Needleless injection site

ES 2 227 552 T3

DESCRIPTION

Set for injections without needle.

Field of the invention

The present invention relates to medical techniques in general, and more particularly to a needleless injection kit usable in connection with intravenous infusions.

Background of the invention

It is common medical practice to infuse various fluids intravenously into a patient's blood vessels. Such infusion is generally performed by inserting a hollow introducer needle into the blood vessel in question. The introducer needle is fluidly connected to one end of an elongated, flexible tube, the opposite end of which is fluidly connected to a bag of solution. The solution bag itself is generally suspended above the patient so as to allow fluid to flow down through a line and into the patient's blood vessel via the introducer needle that remains operatively positioned. within it. The fluid tube and the bag with the solution are connected to each other by means of a measuring device that controls the amount of fluid infusion from the bag into the tube.

In many IV sets, there is an injection set that is fluidly coupled to the line between the introducer needle and the solution bag. The injection assembly is generally of 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 conduit, the lower end of the main body portion being fluidly connected to the introducer needle via a lower segment. of driving. The upper end of the main body portion itself is covered by a diaphragm, which is generally made of rubber or similar elastic material.

The inclusion of the set for injections in the conduit allows various medications to be selectively infused into the patient's blood vessel by adding them to the solution flowing from the solution bag into said blood vessel via the upper segment of the blood vessel. conduit, the set for injections, lower segment of the conduit, and introducer needle. This supplemental infusion is generally effected by using a conventional syringe, the needle of which pierces and passes through the diaphragm provided at the upper end of the main body portion of the injection assembly. After the expulsion of the medication, from the interior of the syringe into the flowing solution, the needle is withdrawn out of the main body portion of the injection assembly, leaving the opening created in the diaphragm by the passage of said needle substantially closed. after said recoil thanks to the elasticity of the diaphragm. As will be appreciated, the incorporation of the injection set into the conduit allows the patient to be administered, intravenously, various medications through the existing infusion set into the blood vessel, thus eliminating the need to subject the patient to additional needle sticks. .

Despite providing various advantages to the patient, injection kits constructed in accordance with the known art possess certain deficiencies which detract from their overall utility. As explained above, the use of such injection assemblies generally requires that the needle of a conventional syringe extend (i.e. pierce) through the diaphragm attached to the upper end of the main body portion of the injection assembly. . In any case, the necessity of having to use a syringe with a needle to facilitate the introduction of the medication into the solution fluid is undesirable due to the risk of inadvertent needle sticks. Recognizing this deficiency, needleless injection sets have been developed in the known art incorporating a diaphragm adapted to assume open and closed configurations without having to insert a needle therein. Although these needleless injection kits eliminate the need to puncture the diaphragm with a needle, they have certain shortcomings that are detrimental to their joint usefulness. The main of these deficiencies is the difficulty associated with the disinfection of the injection set, and in particular of its diaphragm, subsequent to the infusion of the medication by it. In this regard, after each use of the injection set, the diaphragm must be cleaned, such cleaning generally being effected by the application of alcohol or a similar disinfecting substance. However, due to the configuration of the diaphragm, complete and effective disinfection of the diaphragm is often difficult to achieve, thus increasing the risk of introducing contaminants into the solution flow with subsequent use of the injection set. The present invention is adapted to overcome these and other deficiencies associated with prior art injection kits.

We know the description of document US-A5108380 referring to a valve assembly for a connecting member of a catheter, in which the valve body has an axially and elastically displaceable valve with an opening at one end between legs that can be pressed and separated. by fluid pressure with the valve in a displaced position. Summary of the invention

The present invention relates to a set for needleless injections as defined in claim 1.

According to a first embodiment of the present invention, a needleless injection assembly comprising a body is provided. The body itself consists of a main body portion defining proximal and distal ends, and an inner recess that extends axially from part to part. The body further comprises a lateral tubular arm portion that is in fluid communication with the main body portion.

Incorporated at the proximal end of the main body portion is a valve member which extends into said inner recess and in which an opening and elastically closable is formed. Said valve member normally remains in a closed position in which the

The opening is in a closed configuration. In the first embodiment, the valve member is deformable such that application of pressure distally thereto causes it to advance distally into the interior hollow toward an open position in which the opening assumes an open configuration. Conversely, removal of the pressure directed distally from the valve member will cause it to spring back to the closed position in which the opening assumes the closed configuration.

The valve member is preferably made of silicone and comprises a proximal portion of circular configuration that defines an upper surface and has a flange formed around the periphery thereof to incorporate the valve member into the main body portion of the assembly. The valve member further comprises a central portion of cylindrical configuration defining a side surface and a lower surface bearing a notch of conical configuration. The opening extends from the upper surface of the portion proximal to the apex of the notch. In addition to the proximal and central portions, the valve member includes an invertible tubular distal portion adapted to overlap the lateral surface of the central portion and radially apply an inward pushing force thereto, when inverted, which maintains the opening. in the closed configuration when no distal directed pressure is applied to the upper surface of the proximal portion.

The injection assembly of the first embodiment further comprises a locking ring adapted to secure the valve member to the proximal end of the main body portion. In this regard, the flange of the valve member is rigidly clamped between the main body portion and the closure ring. Additionally, formed on the outer surface of the main body portion, adjacent to the proximal end thereof, are Luer-type threads.

In accordance with a second embodiment of the present invention, a needleless injection assembly is provided comprising a body that also has a main body portion defining proximal and distal ends and an interior hollow that extends axially from part to side. part. Formed at the proximal end of the main body portion and extending axially therefrom is an expander stem. Said spreader rod defines a longitudinally extending fluid conduit which is in fluid communication with said inner recess. Incorporated at the proximal end of the main body portion is a connection cap that defines a central opening into which the expander stem extends. The body further comprises a tubular side arm portion that is in fluid communication with the main body portion.

Disposed within the recess of the connection cap is a valve member carrying an opening and closing elastically openable, and which normally remains in a closed position in which the opening is in a closed configuration. The body expander stem extends into the valve member. Said valve member is deformable such that the application of pressure directed distally thereto causes it to advance distally within the opening towards an open position in which the opening is forced by a portion of the expander stem. Conversely, removal of the pressure directed distally from the valve member will cause it to spring back to the closed position in which the opening assumes the closed configuration.

In the second embodiment, the valve member is incorporated into the connection cap and comprises a proximal portion of circular configuration that defines an upper surface and has a flange formed around the periphery thereof for fixing the valve member to said connection cap. . The valve member further comprises a central portion of cylindrical configuration defining a lateral surface and a lower surface bearing an elongated and generally concave recess which is dimensioned and configured to receive the expander stem. The opening extends from the upper surface of the portion proximal to the cusp of the recess. In addition to the proximal and central portions, the valve member includes a tubular, invertible distal portion adapted to overlap the lateral surface of the central portion and radially apply an inward thrust force to it when inverted, which maintains the opening in the closed configuration when no distally directed pressure is applied to the upper surface of the proximal portion. Like the valve member previously described in connection with the first embodiment, the valve member constructed in accordance with the second embodiment is preferably made of silicone. Additionally, said valve member is preferably engaged in cooperation with the expander stem and disposed abutting the proximal end of the main body portion.

The body cap includes luer-like threads formed on the outer surface thereof adjacent the central opening. Additionally, the main body portion normally remains in a first position within the port cap, and is adapted to move distally relative to the port cap toward a second position within it when a distally directed pressure is applied to the valve member. Cessation of pressure directed distally from the valve member causes the main body portion to spring back to the first position. Said main body portion preferably includes a leaf spring molded thereon which is cooperatively engaged with the connection cap and adapted to bias the main body portion towards the first position.

Brief description of the drawings

These, as well as other features of the present invention, will be better appreciated with reference to the drawings in which:

Figure 1 is a perspective view of the needleless injection assembly constructed in accordance with a first embodiment of the present invention;

Figure 2 is a sectional view taken along line 2-2 of Figure 1;

Figure 3 is a sectional view of the valve member incorporated in the needleless assembly illustrated in Figure 1;

Figure 4 is a perspective view of the valve member shown in Figure 3;

Figure 5 is a sectional view illustrating how the valve member deforms from a closed position to an open position;

Figure 6 is a side elevational view of a needleless injection assembly constructed in accordance with a second embodiment of the present invention further illustrating various devices that may be connected thereto;

Figure 7 is a sectional view of the valve member incorporated into the needleless injection assembly illustrated in Figure 6;

Figure 8 is an exploded perspective view of the main body portion and valve member of the needleless injection assembly depicted in Figure 6;

Figure 9 is a partial sectional view of the needleless injection assembly illustrated in Figure 6, with the valve member thereof in a closed position;

Figure 10 is a partial sectional view of the needleless injection assembly depicted in Figure 6, with the valve member thereof having been deformed into an open position;

Figure 11 is a side elevation view of another set for needleless injections, which is not part of the present invention, further illustrating a Luer-type connector and a conduction end to which it can be connected;

Figure 12 is a side elevational view of the needleless injection assembly, not part of the present invention, connected to a bottle;

FIG. 13 is a sectional view of the valve member incorporated into the needleless injection assembly illustrated in FIGS. 11 and 12;

Figure 14 is an exploded perspective view of the needleless injection assembly not part of the present invention;

FIG. 15 is a sectional view of the needleless injection assembly illustrated in FIGS. 11 and 12 connected to a Luer-type connector, with the valve member thereof having been deformed to an open position;

FIG. 16 is a sectional view of the needleless injection assembly depicted in FIGS.

and 12 connected to a "Y" injection assembly, with the valve member thereof having been deformed into an open position; and FIG. 17 is a sectional view of the needleless injection assembly illustrated in FIGS. 11 and connected to a fluid line, with the valve member thereof being in a closed position. Detailed description of the preferred embodiment

With reference now to the drawings, the illustrations of which are only for the purpose of illustrating preferred embodiments of the present invention, and not for the purpose of limiting them, Figure 1 illustrates in perspective a needleless injection assembly 10 constructed in accordance with a first embodiment of the present invention. In said first embodiment, the injection assembly 10 comprises a body 12 configured in a Y. The body 12 itself comprises a main body portion 14 defining a proximal end 16, a distal end 18, and an inner recess 20 that extends axially from part to part. The body 12 itself further comprises a tubular side arm portion 22 that extends angularly from the main body portion 14 and defines an interior gap 24 in fluid communication with the interior gap 20 of the main body portion 14. In typical intravenous infusion applications, the side arm portion 22 is fluidly connected to a suspended bag of solution via an upper segment of a fluid line. The same distal end 18 of main body portion 14 is fluidly connected to a hollow introducer needle via an elongated lower segment of a fluid tubing, thereby allowing solution to flow from the bag into a blood vessel in question. via the upper segment of the conduit, the injection assembly 10, the lower segment of the conduit, and the introducer needle.

Referring now to Figures 2-5, incorporated into the proximal end 16 of the main body portion 14 is a valve member 26 that is made of an elastic material and extends into the interior hollow 20. As best seen in the figures 3 and 4, said valve member 26 comprises a proximal portion of circular configuration 28 defining an upper surface 30 and including a flange 32 formed around the periphery thereof. The valve member 26 further comprises a central portion of cylindrical configuration 34 defining a side surface 36 and a bottom surface 38 having a notch of conical configuration 40 formed in the center thereof. In addition to the proximal and central portions 28, 34, the valve member 26 comprises a tubular distal portion 42 that includes an annular rim 44 formed around the interior surface thereof. The distal portion 42 is preferably formed such that it carries a cut 46 disposed in the corner region defined between the rim 44 and the remainder of the distal portion 42. Extending from the surface 30 of the proximal portion 28 toward the cusp of the Notch 40 is an opening 48 that is elastically openable and closable. In injection assembly 10, valve member 26 normally remains in a closed position wherein said opening 48 is in a closed configuration.

To maintain the opening 48 in the closed configuration, the distal portion 42 of the valve member 26 is formed to be invertible relative to the remainder thereof. As best seen in Figures 2 and 5, distal portion 42, when inverted, is adapted to overlap lateral surface 36 of central portion 34 and radially apply an inward thrust force thereto that maintains said aperture. in the closed configuration. Said inversion is effected by initially turning flange 44 outwardly, thereby causing it to extend radially outward with respect to the remainder of distal portion 42. The outward turning of flange 44 is aided by the inclusion of cutout 46 in the interior of distal portion 42. Thereafter, said distal portion 42 is turned toward proximal portion 28, with flange 44 inserting into annular channel 50 defined between proximal and central portions 28,34. When the distal portion 42 is properly inverted, the valve member 26 assumes the configuration shown in Figure 2. For ease of manufacture, the valve member 26 is molded in the manner illustrated in Figures 3 and 4, with the distal portion 42 of it being inverted in the manner already mentioned prior to the incorporation of the valve member 26 into the proximal end 16 of the main body portion

ES 2 227 552 T3 pal 14. As explained above, due to the elasticity of the material from which the valve member 26 is made, the inversion of the distal portion 42 facilitates the radial application of an inward thrust force to the central portion. 34, thus maintaining the opening 48 in the closed configuration.

In injection assembly 10, body 12 further comprises an annular locking ring 52 for securing valve member 26 to proximal end 16 of main body portion 14. In particular, the fixation of the valve member 26 to the main body portion 14 is effected by rigid clamping of the flange 32 between the main body portion 14 and the closing ring 52 which, in turn, is fixed to the portion. of main body 14 by means of a sonic bonding procedure. When attached to the main body portion 14 by means of the closure ring 52, the central portion 34 of the valve member 26 (which is covered by the inverted distal portion 42) remains within the interior recess 20.

Valve member 26, due to its construction, is deformable such that application of a distally directed pressure thereto will advance it distally into inner hollow 20 toward an open position in which opening 48 assumes an open configuration (such as shown in figure 5). Conversely, removal of pressure directed distally from valve member 26 will cause it to spring back to the closed position in which opening 48 assumes the closed configuration. In particular, when the valve member 26 is in the closed position (as illustrated in Figure 2), the upper surface 30 of the proximal portion 28 extends over (that is, covers) the proximal end 16 of the body portion. main 14, with opening 48 in the closed configuration due to the inward bias force applied radially to central portion 34 by inverted distal portion 42. When the tip 54 of an introducer device is used to apply distally directed pressure to the upper surface 30 of the proximal portion 28, such application of pressure causes the valve member 26 (with the exception of the flange 32) to advance distally into the gap. inside 20 (as shown in figure 5). Due to the rigid incorporation of flange 32 into proximal end 16 of main body portion 14 by means of closure ring 52, advancement of valve member 26 distally into interior recess 20 causes opening 48 to assume the open configuration. , which allows fluid to flow from outlet conduit 58 of introducer device 56 into interior recess 20 via the path defined by open opening 48 and notch 40. In addition, due to the elasticity of the valve member 26, the removal of the introducer device 56 from the interior of the injection assembly 10 allows it to elastically return to its closed position (shown in Figure 10), thus causing the opening 48 to adopt once plus the closed configuration. In this regard, when distally directed pressure is not applied to the upper surface 30 of the proximal portion 28, the opening 48 is held in the closed configuration by the thrust force exerted radially inward on the central portion 34 by the distal portion. inverted 42. Tip 54 of introducer device 56 is preferably sized with an outer diameter dimension that is slightly less than the inner diameter dimension of inner bore 20, thus allowing the taut region of proximal portion 28 to form a seal between the outer surface of tip 54 and inner surface of inner recess 20.

In injection assembly 10, valve member 26 is preferably made of silicone, although similar elastic materials, such as rubber, may be used as an alternative. Additionally, the outer surface of main body portion 14 preferably includes Luer-type threads 60 formed thereon and adjacent proximal end 16 to allow introducer devices, such as Luer-type connectors, to interface with the injection assembly. 10. Advantageously, the uniform upper surface 30 defined by the proximal portion 28 when the valve member 26 is in the closed position allows quick and easy cleaning and disinfection thereof. Although valve member 26 has been described using it in conjunction with Y-shaped body 12, it will be understood that valve member 26 could also be used in association with a Luer-type connector, conventional liquid tubing, or any other type of injection assembly. .

Referring now to Figure 2a, there is illustrated a valve member 26a that is adapted to be incorporated into the proximal end of an alternative Y-shaped body 12a. Said valve member 26a is substantially identical to valve member 26 described above and comprises a proximal portion of circular configuration 28a that defines an upper surface 30a and includes flange 32a formed around the periphery thereof. The valve member 26a further comprises a central portion of cylindrical configuration 34a that defines a lower surface 38a with a conical notch 40a formed in the center thereof and a lateral surface that is overlapped by a distal, tubular and inverted portion. 42a. Extending from the upper surface 30a of the proximal portion 28a to the cusp of the notch 40a is an opening 48a that is elastically openable or closable. The only difference between valve member 26a and valve member 26 is in the configuration of flange 32a which is substantially longer than flange 32 for reasons that will be explained later.

The body 12a, into which the valve member 26a is incorporated, is similar to the body 12 described above, but does not carry the Luer-like threads 60 on the outer surface of the main body portion 14a thereof. Instead, the proximal portion of said main body portion 14a of body 12a defines a generally smooth outer surface over which flange 32a extends. As an alternative to the closure ring 52 described above, the body 12a further comprises an annular closure ring 52a adapted to secure the valve member 26a to the proximal end of the main body portion 14a. In particular, the fixing of the valve member 26a to the main body portion 14a is effected by rigid clamping of the flange 32a between the main body portion 14a and the closing ring 52a which, in turn, is incorporated into a annular step 53a formed around the outer surface of main body portion 14a by means of a sonic bonding process. The outer surface of the

ES 2 227 552 T3 locking ring 52a is preferably formed with Luer-type threads 60a to allow introducer devices, such as Luer-type connectors, to mutually engage with body 12a.

Although not illustrated, it will be understood that alternative means may be used to apply an inward bias force radially to the central portion 34, 34a of the valve member 26, 26a to maintain the opening 48, 48a in the closed configuration. In this regard, the valve member 26, 26a could be formed without the invertible distal portion 42,42a, the inward thrust force being applied radially to the central portion 34, 34a by an O-ring that is housed in the annular groove 50 , 50a defined between the proximal portion 28, 28a and the central portion 34, 34a.

Referring now to Figures 6-10, a needleless injection assembly 70 constructed in accordance with a second embodiment of the present invention is illustrated. In said second embodiment, the injection assembly 70 preferably comprises a Y-shaped body 72, although said body 72 may alternatively have a straight configuration. Body 72 itself comprises a main body portion 74 that defines a proximal end 76, a distal end 78, and an inner recess 80 that extends axially from part to part. Extending angularly from the main body portion 74 is a tubular side arm portion 82 which is in fluid communication with the inner recess 80 of the main body portion 74. In typical intravenous infusion applications, the side arm portion 82 of the body 72 is fluidly connected to a bag of suspended solution via an upper segment of a fluid line. Said distal end 78 of main body portion 74 is fluidly connected to a hollow introducer needle via an elongated lower segment of the fluid tubing, thus facilitating the solution to flow from the bag into the blood vessel in question via of the upper line segment, the injection assembly 70, the lower line segment, and the introducer needle.

With reference to Figures 8-10, formed on and extending axially from the proximal end 76 of the main body portion 74 is an expander stem 84. Said expander stem 84 defines a longitudinally extending fluid conduit 86 which is in fluid communication with and coaxially aligned with inner gap 80. Formed around the outer surface of the expander stem 84 is a retaining rib 88 having a generally triangular cross-sectional configuration. Also formed at the proximal end 76 of the main body portion 74 is an annular neck 90 that surrounds said expander stem 84. As best seen in Figure 8, the neck 90 is formed at the proximal end 76 so that the stem expander 84 is centered with respect thereto. Additionally, as best seen in Figures 9 and 10, said neck 90 is formed to define a flared profile that terminates approximately at the most distal surface of retaining rib 88.

In addition to the expander stem 84 and neck 90, formed in the proximal end 76 of the main body portion 74 and extending radially outward therefrom is a stop flange 92. Formed on the proximal surface of said stop flange 92 and extending perpendicular to it are a pair of opposed anti-rotation projections of identical configuration 94. Each of said projections 94 has a height substantially the same as neck 90 and extends generally parallel thereto. Extending radially from the peripheral edge of stop flange 92 and in opposite directions is a pair of stop tabs 96 of identical configuration. Formed around and extending radially outward from the outer surface of main body portion 74 and in opposite directions are a pair of leaf springs 98. Said leaf springs 98, which are located on the main body portion 74 distally of the stop flange 92, are of thin configuration to provide elasticity thereto for reasons that will be explained later. Also formed around and extending radially outward from the outer surface of main body portion 74 is a pair of successive centering flanges 100 of identical configuration, which are located on main body portion 74 distally of leaf springs 98.

In the second embodiment, the body 72 further comprises a hollow connection cap 102, which is incorporated into the proximal portion of the main body portion 74. The connection cap 102 includes an annular mating region 104 formed at the end. proximal of it. Said coupling region 104 defines a central opening 106 which communicates with the hollow interior of the connection cap 102. Additionally, formed on the outer surface of said coupling region 104 are Luer-like threads 108. Coupling of the connection cap 102 to the main body portion 74 is facilitated by the housing of the stop tabs 96 in an annular recess 110 which is disposed on the inner surface of the connection cap 102 and defines a proximal abutment surface 112 and a distal abutment surface 114. When the stop tabs 96 are properly housed in the recess 110, the protrusions 94 formed on the proximal surface thereof are housed in complementary recesses 116 which are disposed on the interior surface of the connection cap 102 and extend longitudinally. from the proximal abutment surface 112 of the recess 110, toward the proximal end of said connection cap 102. As will be discussed in greater detail later, the housing of the projections 94 in the recesses 116 has the mission of preventing the rotation of the connection cap 102 with respect to the main body portion 74.

In addition to the housing of the stop tabs 96 in the recess 110, the peripheral portions of the leaf springs 98 are housed in an annular groove 118 which is also disposed on the inner surface of the connection cap 102 and located distally of the recess 110. When the stop tabs 96 and leaf springs 98 are housed in the recesses 110, 118, the expander stem 84 extends axially towards the central opening 106 of the connection cap 102, but does not protrude from the coupling region 104 thereof. When said connection cap 102 is attached to the main body portion 74 in the aforementioned manner

ES 2 227 552 T3 da, the centering flanges 100 are adapted to keep the main body portion 74 centered within the connection cap 102 such that the expander stem 84, and in particular the fluid conduit 86 thereof, remains coaxially positioned within central aperture 106.

Referring now to Figures 7-10, disposed within said central aperture 106 of connection cap 102 and cooperatively engaged in expander stem 84 is a valve member 120 which is made of an elastic material. As best appreciated in Figures 7 and 8, said valve member 120 comprises a proximal portion of circular configuration 122 that defines an upper surface 124 and includes a flange 126 formed around the periphery thereof. The valve member 120 further comprises a central portion of cylindrical configuration 128 defining a lateral surface 130 and a lower surface with an elongated generally concave recess 134 formed in the center thereof. It should be noted that the recess 134 has a shape complementary to that of the expander stem 84 and that it defines an annular groove 136 within its side wall. In addition to the proximal and central portions 122,128, the valve member 120 comprises a tubular distal portion 138 that includes an annular rim 140 formed around the interior surface thereof. Also formed around the inner surface of the distal portion 138, immediately adjacent to the lower surface 132 of the central portion 128, is an annular extension 139. Extending from the upper surface 124 of the proximal portion 122 of the cusp of the gap 134 is an opening 142 capable of being elastically opened and closed. In injection assembly 70, valve member 120 is normally in a closed position in which opening 142 is in a closed configuration.

To maintain said opening 142 in the closed configuration, distal portion 138 of valve member 120 is formed to be invertible with respect to the remainder thereof. As best seen in FIG. 7, the distal portion 138, when inverted, is adapted to overlap the lateral surface 130 of the central portion 128 and radially apply an inward biasing force thereto that holds the aperture 142 in place. the closed configuration. Said inversion is effected by initially turning flange 140 outward, thereby causing it to extend radially outward relative to the remainder of distal portion 138. Thereafter, distal portion 138 is turned toward proximal portion 122, with flange 140 inserting it into annular groove 144 defined between proximal and central portions 122, 128. When flange 140 is inserted into throat 144, extension 139 extends radially outward with respect to the remainder of valve member 120. When distal portion 138 is appropriately inverted, valve member assumes the configuration illustrated in Figure 8. For ease of manufacture, the valve member 120 is molded in the shape shown in Figure 7, with the distal portion 138 thereof being inverted in the aforementioned manner prior to insertion of the valve member 120 into the central opening 106 and engagement of the same on the expander stem 84. As previously explained, due to the elasticity of the material from which the valve member 120 is made, the inversion of the distal portion 138 facilitates the application of a radial pushing force inward to the central portion 128, thereby maintaining the opening. 142 in the closed configuration.

In the injection assembly 70, the body 72 further comprises an annular locking ring 146 for securing the valve member 120 to the connection cap 102, and in particular to the coupling region 104 thereof. The fixation of the valve member 120 to the connection cap 102 is accomplished by rigidly entrapment of the flange 126 between the outer surface of the coupling region 104 and the closure ring 146 that is fixed to the connection cap 102 by means of a method. sonic bonding. When attached to the end cap 102 by means of the locking ring 146, the central portion 128 of the valve member 120 (which is covered by the inverted distal portion 138) remains within the central opening 106 and the hollow interior of the end cap. 102.

As noted above, in addition to being rigidly secured to connection cap 102, valve member 120 is cooperatively engaged in expander stem 84. In injection assembly 70, such cooperative engagement is achieved by inserting expander stem 84 into the hollow 134 of valve member 120. When the expander stem 84 is fully inserted into the recess 134, the retaining rib 88 formed around it is housed in the slot 136 provided in the side wall of the recess 134. When the retaining rib 88 is housed in said groove 136, the distal portion of the valve member 120 is compressed, and therefore tightly contained, within the annular space defined between the expander stem 84 and the neck 90, with the extension 139 extending radially outward from the valve member 120 and abutting against the inner surface of the neck 90 and with the distal end of the valve member 120 abutting the proximal end 76 of the main body portion 74. Advantageously, the formation of the proximal edge of neck 90 with a flared profile aids insertion of the distal portion of valve member 120 into the annular space between expander stem 84 and neck 90. The distal portion of valve member 120 is held in the annular space between said expander stem 84 and neck 90 in part by retaining rib 88 which, when housed in groove 136, prevents movement of valve member 120 proximally relative to each other. to the expander stem 84. As will be understood, insertion of valve member 120 into expander stem 84 generally occurs prior to attachment thereof to connection cap 102 via locking ring 146.

Valve member 120, due to its construction, is deformable such that application of a distally directed pressure thereto will advance it distally within central opening 106 toward an open position in which opening 142 assumes an open configuration ( as seen in figure 10). Conversely, removal of pressure directed distally from valve member 120 will spring back to the closed position in which opening 142 assumes the closed configuration (as seen in FIG.

ES 2 227 552 T3

9). In particular, when the valve member 120 is in the closed position, the upper surface 124 of the proximal portion 122 extends over (i.e., covers) the proximal end of the coupling region 104, with the opening 142 in the closed configuration. due to the inward bias force applied radially to central portion 128 via inverted distal portion 138. When the tip 148 of an introducer device 150 (such as a syringe or Luer connector as illustrated in Figure 6) is used to apply a distally directed pressure to the upper surface 124 of the proximal portion 122, such application of pressure causes valve member 120 (except flange 126) to advance distally into central opening 106, as illustrated in FIG. 10.

Advancing valve member 120 distally into central aperture 106 causes aperture 142 to be forced onto flare boss 84 so that the proximal tip of flare stem 84 protrudes from top surface 124 of proximal portion 122 and is received in the outlet conduit 152 of the introducer device 150. The extension of the expander stem 84 through the aperture 142 allows fluid to flow from the outlet conduit 152 of the introducer device 150 into the interior recess 80 via the fluid conduit 86 of the expander stem 84. Due to the elasticity of the valve member 120, its engagement with the expander stem 84 and its rigid fixation with the coupling region 104, the removal of the introducer device 150 from the interior of the injection assembly 70 allows it to elastically return to its normal position. closure, thereby causing the opening 142 to once again assume the closed configuration. In that regard, when no distally directed pressure is applied to the upper surface 124 of the proximal portion 122, the opening 142 is held in the closed configuration by the radially inward pushing force exerted on the central portion 128 by the distal portion. inverted 138. The tip 148 of the introducer device 150 is preferably dimensioned with an outer diameter dimension slightly less than the inner diameter dimension of the central opening 106, thus allowing the stretched region of the proximal portion 122 to form a seal between the outer surface of the tip 148 and the inner surface of central aperture 106.

In injection assembly 70, valve member 120 is preferably made of silicone, although similar elastic materials such as rubber may be used as an alternative. Advantageously, the Luer-type threads 108 formed on the outer surface of the coupling region 104 allow introducer devices, such as Luer-type connectors, to be interconnected to the injection assembly 70. Additionally, the uniform upper surface 124 defined by the proximal portion 122 when the valve member 120 is in the closed position, allows for quick and easy cleaning and disinfection thereof.

With reference to Figures 9 and 10, the main body portion 74 of the body 72 normally remains in a first position within the connection cap 102 (as shown in Figure 9) and is adapted to move distally with respect to said cap. of connections 102 to a second position therein when a distally directed pressure is applied to valve member 120 (as illustrated in FIG. 10). When distally directed pressure is removed from valve member 120, main body portion 74 is adapted to spring back to the first position. In injection assembly 70, main body portion 74 is urged to the first position by leaf springs 98 which are molded on the outer surface thereof and housed in groove 118 provided on the inner surface of connection cap 102 . When a distally directed pressure is applied to the valve member 120, and in particular to the upper surface 124 of the proximal portion 122, the main body portion 74 moves distally within the interior of said connection cap 102 toward its second position, thereby which entails the bending of the leaf springs 98. The distal movement of the main body portion 74 within the connection cap 102 is limited by the contact of the stop tabs 96 against the distal stop surface 114 defined by the recess 110. When such stop contact occurs, the stop portion main body 74 is in the second position. It should be noted that the anti-rotation projections 94 are dimensioned such that when the stop tabs 96 make contact against the distal stop surface 114, the projection portions 94 remain within their respective recesses 116. Distally directed pressure exerted on upper surface 124 of proximal portion 122 is transmitted to main body portion 74 via valve member 120 which, as previously indicated, is cooperatively engaged with expander stem 84 and abuts against it. proximal end 76 of main body portion 74.

When distally directed pressure is removed from upper surface 124 of proximal portion 122, leaf springs 98 return to their original, unflexed positions, which results in displacement of main body portion 74 proximally within connection cap 102. towards your first position. Proximal movement of main body portion 74 within connection cap 102 is limited by contact of stop tabs 96 against proximal stop surface 112 defined by recess 110. When such stop contact occurs, stop portion main body 74 is in the first position. It is noteworthy that the length of travel of the main body portion 74, as it travels from the first to the second position, is significantly less than the length of travel of the valve member 120 when it is moved from the closed position. to the open position, thus allowing the opening 142 of the valve member 120 to be forced onto the expander stem 84 despite distal displacement of the main body portion 74 within the connection cap 102. The return of the main body portion 74 to the first position, Although primarily facilitated by the action of leaf springs 98, it is also aided by valve member 120. In this regard, due to the cooperative engagement of the valve member 120 with the expander stem 84 facilitated by the retaining rib 88 in the groove 136, the elastic return of the valve member 120 to the closed position pulls the expander stem 84, and therefore the main body portion 74, proxi

ES 2 227 552 T3 towards the proximal end of the connection cap 102.

Although not illustrated, it will be understood that alternative means may be employed to provide the radially inward biasing force to the central portion 128 of the valve member 120 to maintain the opening 142 in the closed configuration. In this regard, the valve member 120 may be formed without the invertible distal tubular portion 138, with the inward thrust force applied radially to the central portion 128 by means of an O-ring housed in the annular groove 144 defined between the proximal portions. and central 122, 128.

Referring now to Figures 11-17, a needleless injection assembly 160 is illustrated that is not part of the present invention. As will be described in greater detail below, the injection assembly 160 is adapted to selectively engage a Luer connector 162 (as shown in Figures 11 and 15), to a standard fluid line 164 (as shown in Figures 11 and 17). ), to a Y-shaped injection assembly (as shown in Figure 16), and to a bottle 168 (as shown in Figure 12). However, it will be understood that injection assembly 160 may additionally be fluidly coupled to various other intravenous infusion components. The injection assembly 160 comprises a body 170 which, in turn, consists of an adapter member 172 defining a proximal end 174, a distal end 176, and an inner chamber 178.

Referring now to Figures 14-17, adapter member 172 comprises an upper section 180 that defines proximal end 174, a lower section 182 that is rigidly coupled to upper section 180 and defines distal end 176. Lower and lower sections and upper 180,182, when coupled together, define inner chamber 178. When said upper and lower sections 180, 182 are rigidly coupled to each other, the distal portion of the upper section 180 is positioned concentrically within the proximal portion of the lower section 182. Formed on the proximal end 174 of the adapter member 172 is a stem. expander 184 defining a proximal portion 186 that extends axially from proximal end 174, and a distal portion 188 that extends axially toward inner chamber 178. The expander stem 184 further defines a longitudinally extending fluid conduit 190 that is in fluid communication with the inner chamber 178. Formed around the outer surface of the proximal portion 186 of the expander stem 184 is a retention rib 192 having a generally triangular section configuration. The distal portion 188 of the expander stem 184 preferably has a pointed outer surface to facilitate connection of the body 170 with the fluid line 164, as will be described in greater detail below. Additionally, the distal end of distal portion 188 preferably has a beveled configuration that defines a piercing tip 194. Formed on the pointed outer surface of distal portion 188 and extending longitudinally from proximal end 174 of adapter member 172 toward approximately the midpoint of distal portion 188 is an elongated rib 189, the utility of which will also be discussed later.

In addition to the expander stem 184, formed in the proximal end 174 of the adapter member 172 and extending radially outward therefrom is a stop flange 196. Formed on the proximal surface of said stop flange 196 and extending perpendicular to it is a pair or of opposed anti-rotation projections 198 of identical configuration. Furthermore, formed around and extending radially outward from the outer surface of the adapter member 172, and in particular the upper section 180 thereof, is a leaf spring 200. Said leaf spring 200, which is located on the upper section 180 distally of the stop flange 196, is of thin configuration to provide it with elasticity for reasons that will also be discussed later.

In the third embodiment, the body 170 further comprises a hollow connection cap 202 which is attached to the adapter member 172. The connection cap 202 includes an annular mating region 204 formed at the proximal end thereof. Coupling region 204 defines a central opening 206 that communicates with the hollow interior of connection cap 202. Additionally, formed on the outer surface of coupling region 204 are Luer-like threads 208. Attachment of connection cap 202 to adapter member 172 is facilitated by housing the peripheral portion of stop flange 196 in an annular recess. 210 which is disposed on the inside surface of the connection cap 202 and defines a proximal stop surface 212 and a distal stop surface 214. When stop flange 196 is properly housed in recess 210, projections 198 formed on the proximal surface thereof are housed in complementary grooves 216 that are disposed on the interior surface of connection cap 202 and extend longitudinally from the end cap. proximal abutment surface 212 of recess 210 toward the proximal end of connection cap 202. As will be discussed in greater detail below, the housing of the projections 198 in the grooves 216 is intended to prevent rotation of the connection cap 202 with respect to the adapter member 172.

In addition to housing the stop flange 196 in the recess 210, the peripheral portion of the leaf spring 200 is housed in an annular groove 218 that is also disposed on the inner surface of the connection cap 202 and positioned distally of the recess 210. When stop flange 196 and leaf spring 200 are housed in recesses 210, 218, proximal portion 186 of expander stem 184 extends axially toward the central opening 206 of connection cap 202, but does not protrude from the mating region. 204 of the same. The lower section 182 of the adapter member 172 is preferably dimensioned with an outer diameter dimension slightly less than the inner diameter dimension of the connection cap 202 with the effect of holding the adapter member 172 centrally within the connection cap 202 so that the proximal portion 186 of the expander stem 184, and in particular the fluid conduit 190 thereof, remain coaxially positioned within central aperture 206.

Referring now to Figures 13 and 17, disposed within the central opening 206 of the hood

ES 2 227 552 T3 connector 202 and cooperatively nested in the proximal portion 186 of the expander stem 184 is a valve member 220 which is made of an elastic material. Said valve member 220 comprises a proximal tubular portion 224 having an extension 226 formed around the outer surface thereof. Valve member 220 further comprises a cylindrically shaped distal portion 228 defining an upper surface 230, a lower surface 232, and a lateral surface 234. Formed in the center of said lower surface 232 is an elongated and generally concave recess 236 which it has a shape complementary to that of the proximal portion 186 of the expander stem 184 and defines an annular groove 238 in its side wall. Extending from the upper surface 230 of the distal portion 228 to the apex of the gap 236 is an opening 240 capable of being elastically opened and closed. In injection assembly 160, valve member 220 normally remains in a closed position in which opening 240 is in a closed configuration.

To maintain aperture 240 in such a closed configuration, proximal portion 224 of valve member 220 is formed to be invertible relative to the remainder thereof. As best seen in FIG. 13, proximal portion 224, when inverted, is adapted to overlap lateral surface 234 of distal portion 228 and radially apply an inward pushing force that maintains aperture 240 in said closed configuration. . Such inversion is effected by initially turning proximal portion 224 toward distal portion 228, and then turning extension 226 outwardly to cause it to extend radially outward relative to the remainder of valve member 220. When proximal portion 224 is properly inverted, the valve member assumes the configuration illustrated in Figure 17. To facilitate construction, valve member 220 is molded as shown in FIG. 13, with proximal portion 224 thereof reversed in the aforementioned manner prior to insertion of valve member 220 into central opening 206 and engagement of the valve member 220. same in the proximal portion 186 of the expander stem 184. As explained above, due to the elasticity of the material from which the valve member 220 is made, the inversion of the proximal portion 224 facilitates the application of a radially inward thrust force on the distal portion 228, thus keeping the opening 240 in the closed configuration. When the valve member 220 is fully inserted into the central opening 206 and cooperatively engaged in the proximal portion 186 of the expander stem 184, the distal portion 228 of the valve member 220 (which is covered by the inverted proximal portion 224) remains within the opening. center 206 and the hollow interior of the connection cap 202. Additionally, the upper surface 230 of the valve member 220, which has a slightly arcuate profile, is substantially flush with the proximal end of the engagement region 204. As previously indicated, the valve member 220 is cooperatively engaged in the proximal portion 186 of the spreader stem 184. In injection assembly 160, such cooperative engagement is achieved by inserting proximal portion 186 into recess 236 of valve member 220.

When proximal portion 186 is fully inserted into gap 236, retaining rib 192 formed around it is housed in groove 238 disposed within the side wall of gap 236. When the same retaining rib 192 is received in throat 238, the distal portion of valve member 220 is constrained between proximal portion 186 and projections 198, with extension 226 extending radially outward from valve member 220 and abutting against the interior surfaces of projections 198 and the distal end of valve member 220 abutted with proximal end 174 of adapter member 172. Valve member 220 is firmly held by proximal portion 186 of expander stem 184 and projections 198 when forced therebetween in the aforementioned manner. The distal portion of the valve member 220 is held between the proximal portion 186 and the projections 198 in part by the retaining rib 192 which, when housed in the throat 238, prevents movement of the valve member 220 proximally relative to the proximal portion. 186.

Valve member 220, due to its construction, is deformable such that application of a distally directed pressure thereto will cause it to advance distally within central aperture 206 toward an open position in which aperture 240 assumes a configuration. open (as seen in Figures 15 and 16). Conversely, cessation of pressure directed distally from valve member 220 will spring back to the closed position in which opening 240 assumes the closed configuration (as shown in FIG. 17). When the valve member 220 is in the closed position, the upper surface 230 thereof becomes substantially flush with the proximal end of the engagement region 204, with the opening 240 being in the closed configuration due to the radially applied inward thrust force. to the distal portion 228 by the inverted proximal portion 224. When the tip 242 of an introducer device 244 (such as a Luer connector as illustrated in Figure 15 and a syringe such as that shown in Figure 16) is used to apply pressure directed distally to the upper surface 230, such application pressure causes valve member 220 to advance distally into central opening 206, as shown in Figures 15 and 16).

Advancing valve member 220 distally into central aperture 206 causes aperture 240 to be forced onto proximal portion 186 of expander stem 184 such that the proximal tip of proximal portion 186 protrudes from upper surface 230 of the distal portion 228 and is housed in outlet conduit 246 of introducer device 244. Extension of proximal portion 186 through aperture 240 allows fluid to flow from outlet conduit 246 of introducer device 244 into and through fluid conduit 190 of expander stem 184. Due to the elasticity of the valve member 220 and its engagement with the expander stem 184, the removal of the introducer device 244 from the interior of the injection assembly 160 allows it to spring back to its closed position, thus causing the opening 240 to adopt once again the closed configuration. In this regard, when no directed pressure is applied

ES 2 227 552 T3 distally to the upper surface 230 of the distal portion 238, the opening 240 is held in the closed configuration by the radially inward pushing force exerted on the distal portion 238 by the inverted proximal portion 224.

In injection assembly 160, valve member 220 is preferably made of silicone, although similar elastic materials such as rubber could alternatively be used. Luer threads 208 formed on the outer surface of engagement region 204 allow an introducer device 244, such as the Luer connector shown in FIG. 15, to remain engaged in injection assembly 160. Additionally, the uniform upper surface 230 defined by the distal portion 228 when the valve member 220 is in the closed position allows for quick and easy cleaning and disinfection thereof.

Referring to Figures 15-17, adapter member 172 of body 170 normally remains in a first position within port cap 202 (as illustrated in Figure 17), and is adapted to move distally with respect to port cap 202 toward a second position therein when a distally directed pressure is applied to valve member 220 (as shown in Figures 15 and 16). Adapter member 172 is adapted to spring back to the first position when distally directed pressure from valve member 220 is removed. In injection assembly 160, adapter member 172 is urged to a first position by leaf spring 200 which is molded. on the outer surface of the upper section 180 thereof and is housed in the recess 210 provided on the inner surface of the connection cap 202. When a distally directed pressure is applied to the valve member 220, and in particular to the upper surface 230 of the distal portion 228, said adapter member 172 moves distally within the interior of the connection cap 202 towards its second position, which entails the deflection of leaf spring 200. The distal displacement of adapter member 172 within connection cap 202 is limited by contact with the peripheral portion of abutment flange 196 against distal abutment surface 214 defined by recess 210. When such contact occurs, adapter member 172 remains in second position. It is important that the anti-rotation projections 198 are dimensioned so that when the abutment flange contacts the distal abutment surface 214, the portions of the projections 198 remain within their respective recesses 216. The distally directed pressure exerted on the upper surface 230 of the distal portion 228 is transmitted to the adapter member 172 through the valve member 220 which, as previously indicated, is cooperatively engaged in the proximal portion 186 of the expander stem 184 and in contact against proximal end 174 of adapter member 172.

When distally directed pressure is removed from upper surface 230 of distal portion 228, leaf spring 200 returns to its original, unflexed position, which causes displacement of adapter member 172 proximally within connection cap 202 toward its first position. . Proximal displacement of adapter member 172 within connection cap 202 is limited by contact with the peripheral portion of abutment flange 196 against proximal abutment surface 212 defined by recess 210. When such contact occurs, adapter member 172 remains in the first position. It is important that the length of travel of the adapter member 172, as it travels from the first to the second position, is significantly less than the length of travel of the valve member 220 as it travels from the closed position to the open position. thus allowing the opening 240 of the valve member 220 to be forced onto the proximal portion 186 of the expander stem 184 despite distal displacement of the adapter member 172 within the connection cap 202. Additionally, anti-twist projections 198 are positioned on the proximal surface of stop flange 196 so as to be longitudinally movable within grooves 216, however preventing extension 226 of valve member 220 from contacting the interior surfaces of they contact the inside surface of the connection cap 202. The return of adapter member 172 to the first position, although facilitated primarily by the action of leaf spring 200, is also aided by valve member 220. In this regard, due to the cooperative engagement of the valve member 220 with the proximal portion 186 of the expander stem 184 facilitated by the housing of the retaining rib 192 in the slot 238, the elastic return of the valve member 220 to the closed position pulls the stem. expander 184, and hence adapter member 172, proximally toward the proximal end of connection cap 202.

Referring now to Figures 14 and 17, defined within the distal end 176 of the adapter member 172, and in particular the lower section 182 thereof, is a closure region to facilitate connection of the injection assembly 160 to an infusion component. , such as a Luer connector 162, to a Y-injection assembly 166 and to a bottle 168. The closure region of adapter member 172 preferably comprises three groups of Luer-type thread pitch barbed projections 248 formed on the inner surface of lower section 182 and equidistantly spaced at approximately 120 ° intervals. Each group of barbed projections 248 extends longitudinally from distal end 176 of adapter member 172 toward inner chamber 178, and terminates approximately at the distal end of upper section 180. As best seen in FIG. 17, each group of barbed projections 248 is formed within lower section 182 so that they are oriented radially inward of the interior surface thereof.

As already explained, adapter member 172 of body 170 consists of upper and lower sections 180, 182 that are rigidly attached to each other. In the third embodiment, the lower section 182 of the adapter member 172 is molded to include a cover member 250 that attaches to one of the groups of barbed projections 248 via a flange 252. Said cover member 250 defines a tapered hole that is complementary to the tapered outer surface of the distal portion 188 of the expander stem 184. In this regard, after assembly of the injection assembly 160 in the aforementioned manner, the stem 252 is severely broken.

ES 2 227 552 T3 nually, thus allowing the cover member 250 to slidely advance over the distal portion 188 of the expander stem 184. Thanks to the inner recess of the cover member 250 and the distal portion 188 having reciprocal tapered configurations, the cover member 250 is frictionally held on distal portion 188 after it has been slidably advanced thereon. Advantageously, cover member 250 prevents any inadvertent contamination of distal portion 188 prior to incorporation of injection set 160 into an intravenous infusion set. Said cover member 250 also prevents a user from being inadvertently injured by piercing tip 194 of distal portion 188.

In addition to the lower section 182 being molded with the cover member 250, the connection cap 202 of the injection assembly 160 is molded to include a tubular adapter sleeve 254 that is secured to the proximal end of the mating region 204 by means of three ( 3) 256 equidistant tails. Said adapter sleeve 254 has a tapered outer surface 257 and includes a tapered inner recess 258 extending longitudinally from part to part which, like the inner recess of the cover member 250, is complementary to the tapered outer surface of the distal portion 188 of the spreader stem 184. Disposed within the side wall of inner recess 258 are a plurality of equidistantly spaced grooves 260 that extend longitudinally from the larger diameter end of adapter sleeve 254 at a depth approximately proportionate with a shoulder 262 defined in outer surface 257. As will be discussed in greater detail below, adapter sleeve 254 is used to facilitate coupling of injection assembly 160 to Luer connector 162. As will be understood, cover member 250 is necessarily removed from lower section 182 (or above). distal portion 188) and adapter sleeve 254 is removed from connection cap 202 prior to use of injection assembly 160.

As previously noted, the injection assembly 160 is adapted to fit a Luer connector 162, a fluid line 164, a Y injection assembly 166, and a bottle 168. As can be seen in FIG. 15, engagement of the injection assembly 160 to a Luer connector 162 is accomplished by slidingly advancing the adapter sleeve 254 over the distal portion 188 of the expander stem 184 after removing the cover member 250 therefrom and separating said adapter sleeve 254 from connection cap 202. Since the outer surface of the distal portion 188 and the inner recess 258 of the adapter sleeve 254 have reciprocally tapered configurations, the adapter sleeve 254 is frictionally held on the distal portion 188 after slidingly advanced thereon. It is important that each of the grooves 260 be sized and configured to slidably receive the rib 189 formed on the outer surface of the distal portion 188, the advancement of the adapter sleeve 254 being limited proximally along the distal portion 188 by contact. of the distal end of rib 189 against the closed end of slot 260 in which it is housed. Advantageously, the housing of the rib 189 in the groove 260 has the function of preventing the rotation of the adapter sleeve 254 on the distal portion 188 of the expander rod 184.

After fixing the adapter sleeve 254 to the distal portion 188 in the aforementioned manner, said adapter sleeve 254 is slidably inserted into the inner conduit of the Luer connector 162. Advancing the adapter sleeve 254 itself into said inner conduit of the Luer connector 162 follows up to the time when Luer threads formed on the outer surface of the same Luer connector 162 are engaged by barbed projections 248 of the closure region. Due to the tapered outer surface 257 of the adapter sleeve 254, it is frictionally held within the inner conduit of the Luer connector 162 after being inserted therein. Furthermore, said Luer-type connector 162 is prevented from being pulled distally from the adapter member 172, and in particular from the adapter sleeve 254, thanks to the engagement of the barbed projections 248 in the Luer-type threads thereof. As such, the combination of the frictional retention of the adapter sleeve 254 within the inner conduit and the engagement of the barbed projections 248 on the luer threads creates a secure interconnection between the injection assembly 160 and the luer connector 162. When valve member 220 is moved to the open position, fluid flows from outlet conduit 246 of introducer device 244 into inner conduit of Luer connector 162 through fluid conduit 190 of expander stem 184 and inner gap 258 adapter sleeve 254.

Referring now to Figure 16, the engagement of the injection assembly 160 to the Y injection assembly 166 is accomplished by initially removing the cover member 250 from the distal portion 188 of the expander stem 184, and removing the adapter sleeve 254 from the connection cap. 202. Thereafter, the injection assembly 160, and in particular the adapter member 172 thereof, is advanced over the upper end of the Y injection assembly 166 such that the distal portion 188 of the expander stem 184 extends into the assembly for injections 166 (with some diaphragm incorporated into the upper end thereof being pierced by piercing tip 194 of distal portion 188). In addition to said distal portion 188 of the expander stem 184 being extended toward the Y-injection assembly 166, the enlarged end region of the Y-injection assembly 166 is captured within the barbed projections 248, thus preventing distal separation thereof from the adapter member 172 and distal portion 188 therein. When valve member 220 is moved to the open position, fluid flows from outlet conduit 246 of introducer device 244 to Y-injection assembly 166 via fluid conduit 190 of expander stem 184. Although not illustrated in detail , the fitting of the injection assembly 160 to the neck of the bottle 168 is carried out in the same manner as described in connection with the Y injection assembly 166.

As seen in FIG. 17, the engagement of the injection assembly 160 to the fluid line 164 is accomplished by initially removing the cover member 250 from the distal portion 18 of the expander stem.

ES 2 227 552 T3

184, and removing the adapter sleeve 254 from the connection cap 202. Then, the distal portion 188 of the expander stem 184 is slidably advanced into the inner passage of the fluid line 164. Thanks to the tapered outer surface of the distal portion 188, it is frictionally held within fluid line 164 after being inserted into the interior conduit thereof. As valve member 220 is moved to the open position, fluid flows from the introducer device into fluid line 164 via fluid conduit 190 of expander stem 184.

Certain additional modifications and improvements to the present invention will also be apparent to those skilled in the art. Thus, the particular combination of the parts described and illustrated herein is intended to represent only certain embodiments of the present invention, and is not intended to serve as limitations to alternative devices that fall within the scope of the invention.