Container and Needle Assembly

1. Field of the Invention

The present invention relates to a syringe barrel or container and hypodermic needle assembly, and an assembly of syringe barrels or containers. More particularly, the present invention relates to a syringe barrel or container and hypodermic needle assembly wherein the hypodermic needle assembly contains a rearwardly facing cannula capable of piercing a barrier within the syringe barrel or container and to an assembly of a plurality of syringe barrels or containers joined by integral web portions.

2. Description of the Prior Art

Generally speaking, a hypodermic syringe consists of a cylindrical barrel, most commonly made of plastic or glass, with a distal end adapted to be connected to a hypodermic needle and a proximal end adapted to receive a stopper and plunger rod assembly. One of the purposes of the stopper is to provide a relatively air-tight seal between itself and the syringe barrel so that movement of the stopper up and down the barrel will cause liquid, blood or other fluids to be drawn into or forced out of the syringe through the distal end. The stopper is moved along the syringe barrel by applying axial force to a rigid plunger rod which is connected to the stopper and is sufficiently long to be accessible outside of the barrel. An example of a rigid barrel syringe is illustrated in U.S. Pat. No. 4,430,080 to Pasquini et al.

Also known to the art are hypodermic syringes having a flexible barrel portion, usually made of thermoplastic material, with a distal end adapted to be connected to a hypodermic needle. With a hypodermic needle attached, the user of a flexible barrel hypodermic syringe assembly may expel the medication by manually squeezing the flexible barrel portion forcing the medication through the hypodermic needle cannula and into the patient. A hypodermic syringe unit having a flexible barrel portion is illustrated in U.S. Pat. No. 2,680,440 to Fox.

A wide variety of injectable medications, or medications which can be rendered into injectable form by the addition of a diluent, are prefilled in rigid and flexible syringe barrel assemblies by pharmaceutical manufacturers, contract packages, and the like. The medication containing syringes often sit many weeks or months before administration of medication to the patient. Under these circumstances, it is desirable to isolate the medication from the environment as thoroughly as possible. This task is more easily accomplished at the proximal end of the syringe where, in the case of a rigid syringe, a resilient rubber stopper can effectively seal the barrel. In the case of a flexible barrel syringe, the proximal end may be sealed shut, for example, by heat sealing, after the syringe is filled with medication. At the distal end of the syringe barrel the problem of isolating the medication from the environment is more difficult to solve. In rigid barrel syringes, it is common practice to seal the tip at the distal end of the syringe with elastomeric tip caps as described in U.S. Pat. No. 4,444,310 to Odell wherein the tip cap is removed at the time of use and a hypodermic needle assembly is placed over the syringe tip. In a rigid barrel syringe, the medication may also be isolated by placing an additional stopper in the syringe barrel so that the medication is contained between two resilient stoppers. When a stopper is used to provide needle isolation, additional structure in the syringe barrel is necessary to allow fluid to bypass the distal-most stopper. An example of this structure is illustrated in U.S. Pat. No. 3,330,282 to Visser et al.

In prefilled flexible barrel syringes, needle isolation may be accomplished by occluding the lumen of the cannula with a removable plug as illustrated in the above-mentioned patent to Fox. Also, needle isolation may be accomplished by providing a barrier between the medication and the syringe tip, and a hypodermic needle having a dual pointed cannula. At the time of use, the hypodermic needle may be moved in a rearward direction so that the rearmost cannula pierces the barrier establishing fluid communication between the chamber containing the medication and the hypodermic cannula. Such a syringe is illustrated in U.S. Pat. No. 4,018,222 to McAleer et al. A pierceable barrier design along the lines taught by McAleer et al. is advantageous with respect to its ability to isolate the medication from the environment, however, it has deficiencies in that the two-pointed cannula may be inadvertently activated by pressure on the needle shield which forces the cannula through the barrier.

Problems also exist in prefilling rigid or flexible syringe barrels. When filling, for example, thousands of syringe barrels, each of these syringe barrels must be delivered to a filling station, filled and then sealed. If the filling station contains multiple filling nozzles all of the syringe barrels in the area must be spaced appropriately so that each is in the proper position with respect to the filling nozzles, and then the syringe barrels are moved as a group to a sealing station which provides for sealing of the proximal ends of the barrels. A rigid barrel syringe may be sealed via introduction of a stopper into the barrel and a flexible barrel syringe may be sealed by compressing the proximal end of the barrel shut and applying heat energy to seal this end shut. One method of accomplishing multiple unit filling and sealing is to place the syringe barrels in a fixture which holds the syringe barrels at a predetermined distance from each other so that all the barrels in the fixture will be properly aligned with the filling station nozzles and, also, the subsequent sealing operation may be performed with the syringe barrels properly positioned. At the end of the operation the individual syringe barrels must be removed from the fixture so that the fixture may be returned and used again. This is a tedious operation requiring care to avoid contamination of the fixtures by spilled medication.

In addition to hypodermic syringe assemblies, medication is routinely administered using intravenous or I.V. administration sets. Most I.V. administration sets include a specific adapter for connection to a reservoir, a flexible transparent drip chamber, tubing, a clamp on the tubing, a "Y" site having a pierceable septum so that a secondary I.V. set can be attached, and an injection needle or catheter. Secondary intravenous set-ups include a smaller container or reservoir for administering medications such as antibiotics and vitamins. Secondary I.V. administration sets usually include an appropriate adapter, a flexible drip chamber, tubing and a needle cannula for piercing the septum at the "Y" site and establishing fluid communication with the primary I.V. set. In some secondary set-ups where flow rate is not critical, medication is injected directly into the I.V. line, as taught in U.S. Pat. No. 2,999,499 to Willet. More commonly, however, the secondary set-up includes another flexible or rigid container for the medication, as illustrated in U.S. Pat. No. 4,432,756 to Urquhart et al.

Secondary intravenous medication containers are routinely prepared by the hospital pharmacy using specialized equipment and procedures which are sometimes unique for the secondary I.V. reservoirs.

Rigid and flexible barrel syringe assemblies for use with prefilled medication, having structure for isolation of the medication from the environment, and methods of prefilling have been addressed by the prior art, as alluded to above. However, there is still a need for simple, straight-forward, reliable, easily fabricated syringe assemblies for the storage and administration of medications. It is desirable that the syringe barrel effectively isolates the hypodermic needle cannula from the medication and the syringe assembly is easily activated, while being difficult to activate inadvertently. It is also desirable to have a group of syringes assembled in a configuration which will eliminate the use of separate fixtures during the prefilling operation.

An operable syringe barrel and hypodermic needle assembly of the present invention includes a barrel portion having a chamber for retaining fluid and a tip portion extending from a distal end of the barrel portion having a passageway therethrough. A projection extends outwardly from the tip portion. Pierceable barrier means is provided for preventing fluid communication between the chamber and the passageway. A hub having a forward end, a rearward end and a conduit therethrough is movably positioned within the passageway. A first cannula extends outwardly from the forward end of the hub and a second cannula extends outwardly from the rearward end of the hub wherein the first cannula and the second cannula are in fluid communication with each other. A needle shield removably engages the tip, covering the first cannula. This needle shield includes an outer extension portion extending over a portion of the tip wherein the outer extension portion is capable of contacting the projection for limiting the motion of the needle shield toward the proximal end of the barrel. The outer extension portion includes a longitudinal groove which is wider than the projection and capable of receiving the projection. The needle shield also includes an inner extension portion projecting proximally into the passageway and capable of contacting the hub. The inner extension portion is long enough so that when the needle shield is rotated to align the groove and projection, and moved in a proximal direction with respect to the tip portion so that the projection enters the groove, the inner extension pushes against the hub and moves the hub in a proximal direction causing the second cannula to pierce the pierceable barrier means.

In accordance with another embodiment of the present invention, an operative syringe barrel and hypodermic needle assembly includes an elongate barrel portion having an open proximal end and a chamber for retaining fluid. A tip portion extends from a distal end of the barrel portion and includes a passageway therethrough. A planar web extends radially outwardly from the tip portion and is substantially parallel to the longitudinal axis of the tip portion. A pierceable barrier extends across the passageway for preventing fluid communication between the chamber and the passageway. A rigid hub having a forward end, a rearward end and a conduit therethrough is movably positioned within the passageway. A first cannula extends outwardly from the forward end of the hub and a second cannula extends outwardly from the rearward end of the hub wherein the first cannula and the second cannula are in fluid communication with each other. An elongate hollow needle shield slidably engages the tip covering the first cannula. This needle shield has an outer skirt portion extending over a portion of the tip. The outer skirt portion is capable of contacting the web for limiting the motion of the needle shield toward the proximal end of the barrel. The outer skirt portion includes a longitudinal groove being wider than the web and capable of receiving the web. The needle shield includes an inner skirt portion projecting proximally into the passageway and capable of contacting the hub. The inner skirt portion is long enough so that when the needle shield is rotated to align the groove in the web, and moved in a proximal direction with respect to the tip portion so that the web enters the groove, the inner skirt pushes against the hub and moves the hub in a proximal direction causing the second cannula to pierce the piercable barrier.

Another aspect of the present invention is a syringe barrel assembly comprising a plurality of syringe barrels each including a barrel portion having an open proximal end, a chamber for retaining fluid, and a tip portion extending from a distal end of the barrel portion having a passageway therethrough. The passageway is adapted to accept the hub and second cannula of a hypodermic needle assembly having a hub, a first cannula extending outwardly from a distal end of the hub and a second cannula extending outwardly from a proximal end of the hub wherein the cannula are in fluid communication. Pierceable barrier means is included in each of the passageways for preventing fluid communication between the chamber and the passageway of each syringe barrel. A plurality of web portions extend radially outwardly from the tip portions connecting the syringe barrels. The web portions are integrally formed from the same material as a syringe barrel. The web portions in the syringe barrels are connected so that the syringe barrels are spaced apart from each other along a substantially straight line wherein the longitudinal axes of the syringe barrels are substantially parallel to each other.

Another embodiment of this other aspect of the present invention is a syringe barrel assembly comprising a plurality of thermoplastic syringe barrels each including a barrel portion having an open flexible proximal end, a flexible chamber for retaining fluid, and a tip portion extending from a distal end of the barrel having a passageway therethrough. The passageway is adapted to accept the hub and second cannula of a hypodermic needle assembly having a hub, a first cannula extending outwardly from a distal end of the hub and a second cannula extending outwardly from a proximal end of the hub wherein the cannulae are in fluid communication. Pierceable barrier means is included in each of the passageways for preventing fluid communication between the chamber and the passageway. A plurality of planar web shaped portions extending radially outwardly from the tip portions connects the syringe barrels. The web portions are substantially parallel to the longitudinal axis of the tip portions. The web portions are integrally formed from the same thermoplastic material as the syringe barrels. The web portions and the syringe barrels are connected so that the syringe barrels are spaced apart from each other along a substantially straight line.

In accordance with another embodiment of the present invention an operative container and needle assembly includes a container body portion having a proximal end, a distal end and a side wall therebetween defining a chamber for retaining fluid and a tip portion extending from the distal end of the body portion having a passageway therethrough. A projection extends outwardly from the tip portion. Pierceable barrier means is provided for preventing fluid communication between the chamber and the passageway. A hub having a forward end, a rearward end and a conduit therethrough is movably positioned within the passageway. A first cannula extends outwardly from the forward end of the hub and a second cannula extends outwardly from the rearward end of the hub wherein the first cannula and the second cannula are in fluid communication with each other. A needle shield removably engages the tip, covering the first cannula. This needle shield includes an outer extension portion extending over a portion of the tip wherein the outer extension portion is capable of contacting the projection for limiting the motion of the needle shield toward the proximal end of the barrel. The outer extension portion includes a longitudinal groove which is wider than the projection and capable of receiving the projection. The needle shield also includes an inner extension portion projecting proximally into the passageway and capable of contacting the hub. The inner extension portion is long enough so that when the needle shield is rotated to align the groove and projection, and moved in a proximal direction with respect to the tip portion so that the projection enters the groove, the inner extension pushes against the hub and moves the hub in a proximal direction causing the second cannula to pierce the pierceable barrier means.

In accordance with the principles of the present invention, a number of advantages and objectives are attained. The present invention provides a simple straight forward, reliable, easily fabricated syringe barrel/container and hypodermic needle assembly for the storage and administration of medication, wherein the structure of the syringe barrel/container and hypodermic needle assembly effectively isolates the hypodermic needle cannula from the medication before the time of use while the syringe barrel/container and hypodermic needle assembly is easily activated intentionally while being difficult to activate inadvertently. Another aspect of the instant invention provides a syringe barrel/container assembly which holds and orients the syringe barrels with respect to each other in order to minimize the need for additional fixturing during prefilling and sealing operations.

FIG. 1 is a perspective view of the syringe barrel and hypodermic needle assembly of the present invention;

FIG. 2 is an explored perspective view of the components of the syringe barrel and hypodermic needle assembly of FIG. 1;

FIG. 3 is a top plan view of the syringe barrel and hypodermic needle assembly of FIG. 1;

FIG. 4 is a side elevation view of the syringe barrel and hypodermic needle assembly of FIG. 1 shown with the proximal end of the barrel portion sealed;

FIG. 5 is a partial enlarged cross-sectional view of the syringe barrel and hypodermic needle assembly of FIG. 3 taken along lines 5--5;

FIG. 6 is an enlarged partial cross-sectional view, similar to the cross-sectional view of FIG. 5, showing the second cannula piercing the barrier to establish fluid communication between the hypodermic needle assembly and the chamber;

FIG. 7 is a perspective view illustrating the expulsion of medication from the syringe barrel using digital force;

FIG. 8 is a perspective view of another embodiment of the present syringe barrel and hypodermic needle assembly wherein the barrel portion is rigid;

FIG. 9 is a perspective view of the syringe barrel and hypodermic needle assembly of FIG. 8 illustrating the position of the needle shield when the needle assembly is in fluid communication with the chamber;

FIG. 10 is a perspective view of the syringe barrel and hypodermic needle assembly of FIG. 9 with the needle shield removed;

FIG. 11 is a perspective view of the syringe barrel assembly of the present invention;

FIG. 12 is a perspective view of the syringe barrel assembly of the present invention with needle shields attached;

FIG. 13 is a side elevation view of a plurality of syringe barrel assemblies nested together in rows;

FIG. 14 is a top plan view of the plurality of syringe barrel assemblies of FIG. 13;

FIG. 15 is a perspective view of another embodiment of the syringe barrel assembly of the present invention wherein the barrel portions are rigid;

FIG. 16 is a perspective view of an embodiment of the container and needle assembly of the present invention wherein the container is formed of flexible film; and

FIG. 17 is a perspective view of another embodiment of the container and needle assembly of the present invention having a rigid body portion with vent means.

While the invention is satisfied by embodiments in many different forms, there is shown in the drawings and will herein be described in detail preferred embodiments of the invention with the understanding that the present disclosure is to be considered as exemplary of the principles of the invention and is not intended to limit the invention to the embodiments illustrated. The scope of the invention will be measured by the appended claims and their equivalents.

Adverting to FIGS. 1-7, an operable syringe barrel and hypodermic needle assembly 20 includes an elongate barrel portion 21 having a chamber 22 for retaining fluid. A tip portion 23 extends from distal end 25 of the barrel portion and includes passageway 26. For purposes of the description of the present invention, the term "distal end" is intended to refer to the end furthest from the person holding the syringe, whereas the term "proximal end" is meant to refer to the end closest to the holder of the syringe.

A planar web 27 extends radially outwardly from the tip portion. A second planar web 28 extends radially outwardly from the tip portion and is oppositely disposed from planar web 27. These webs are substantially parallel to longitudinal axis 29 of the tip portion. A pierceable barrier 31 extends across passageway 26 for preventing fluid communication between chamber 22 and the passageway. In this preferred embodiment, the pierceable barrier is an integrally formed partition of the same material as the tip portion and barrel portion. However, it is within the purview of the instant invention to include a pierceable barrier structure made of different material which is attached to the barrel portion and/or the tip portion via adhesive bonding, ultrasonic welding or other suitable means and that the integral barrier illustrated is exemplary of these many possibilities.

A needle assembly 32 includes a rigid hub 34 having a forward end 35 and a rearward end 37 and a hub passageway or conduit 38 therethrough. Hub 34 is movably positioned within passageway 26. A first cannula 39, having a lumen 40 therethrough, extends outwardly from the forward end of the hub terminating in a sharpened tip 41 adapted to penetrate human flesh. A second cannula 43 having a lumen (not shown) therethrough extends outwardly from rearward end 37 of the hub and terminates in a sharpened tip 44 adapted to penetrate pierceable barrier 31 to establish fluid communication between chamber 22 and the second cannula. In the preferred embodiment as best illustrated in FIG. 5, the first cannula and the second cannula are made of one piece construction and held in position with respect to the hub via adhesive 45, such as epoxy, UV curable adhesive, heat curable adhesive and the like. It is within the purview of the present invention to include a separate cannula wherein the lumens of the separate cannula are joined by the hub passageway or conduit in the hub to form a continuous fluid path from the tip of the second cannula to the tip of the first cannula. It is also within the purview of the instant invention to include a hub wherein the second cannula is integrally molded from the hub material and not a separate component. The one-piece cannula structure of the preferred embodiment is exemplary of these many structural possibilities wherein the first cannula and the second cannula are in fluid communication.

An elongate hollow needle shield 46 slidably engages tip portion 23 while covering first cannula 39. The needle shield includes an outer extension or outer skirt portion 47 extending over a portion of the tip. The outer extension or outer skirt portion includes intermediate surface 49 which contacts web 27 for limiting the motion of the needle shield toward the proximal end of the barrel. Outer extension or outer skirt portion 47 also includes longitudinal groove 50 which is wider than web 27 and capable of receiving web 27 when the needle shield is rotated so that web 27 and groove 50 are aligned. When web 27 and groove 50 are aligned, the needle shield is capable of moving toward the proximal end of the syringe barrel without being obstructed by the structure of the outer skirt portion, so long as web 27 does not contact base 51 of the groove.

Needle shield 46 also includes an inner projection or inner skirt 52 projecting downwardly in a proximal direction into passageway 26 and capable of contacting hub 34, preferably at forward end 35 of the hub. Inner skirt portion 52 is long enough so that when the needle shield is rotated to align groove 50 with web 27 and the needle shield is moved in a proximal direction with respect to the tip portion, web 27 enters groove 50 while inner skirt 52 pushes against the hub and moves the hub in a proximal direction causing second cannula to pierce the pierceable barrier, establishing fluid communication between the chamber and the second cannula, as best illustrated in FIG. 6, the structure of the instant invention which requires the deliberate act of rotating the needle shield to align groove 50 and web 27 helps overcome a major deficiency of the prior art which is inadvertent activation of the syringe by applying force to the needle shield. With the instant invention inadvertent force applied to the needle shield along its longitudinal axis will not cause the second cannula to pierce the barrier unless the needle shield is deliberately oriented to align the groove and the web.

It should be noted that inner skirt portion 52 is preferably, but not necessarily, circularly shaped having a substantially circularly shaped cross section. The inner skirt portion is a projection and may assume a variety of shapes, such as rod-shaped, so long as the projection has the structural integrity necessary to move the needle assembly, and force the second cannula through the pierceable barrier. Further, the shape of outer skirt portion is preferably, but not necessarily, circularly shaped having a substantially circularly shaped cross section. The circular shape of the outer skirt portion is desirable because it provides a rounded knob-like surface for the user to hold the needle shield for the purpose of rotating it or moving it in a longitudinal direction.

It should also be noted that the planar shape of web 27 is the preferred shape of the structure which interacts with groove 50 in the needle shield. However, other projection structures such as a pin or a cantilever member projecting radially outwardly from the tip are also suitable, and within the purview of the present invention. It is also within the purview of the instant invention to include a barrel portion with more than one projection or planar web, and a needle shield with one or more grooves and that the number of grooves does not necessarily have to equal the number of webs so long as one web portion engages one groove to allow movement of the needle shield in a distal direction. It may be desirable to extend the outer skirt portion for more than 180 degrees and to include two web portions on the syringe barrel and two grooves in the outer skirt portion of the needle shield.

This preferred embodiment also includes retention means for holding the needle shield in the predetermined angular position with respect to the tip portion, before use. The retention means preferably includes a weld portion 55 wherein a small portion of the outer skirt is attached to the outer surface of the tip through the application of heat energy, ultrasonic energy, adhesive or other suitable means. The weld portion holds the needle shield in a position which can be changed only by applying a rotational force to the needle shield, with respect to the barrel, which will shear the weld portion at the interface between the needle shield and the syringe barrel. The weld portion provides additional help to overcome a deficiency of the prior art in that it helps prevent the inadvertent activation of the syringe by increasing the force required to align the web portion on the tip and the groove in the needle shield This weld portion also provides tamper evidence, warning the user of potential contamination of syringe barrel assemblies wherein the weld is broken. An alternative positioning means can include a suitable film or paper (not shown) adhesively attached to the outer skirt portion and the syringe barrel or tip so that forced rotation of the needle shield will cause the paper to shear and rip along the interface between the needle shield and the syringe barrel or tip, again helping to prevent inadvertent activation and providing tamper evidence for the user.

Tip portion 23 also includes a first protuberance projecting radially inwardly into passageway 26. Protuberance 56 is shaped to allow the hub to pass thereover when manual force is applied to the hub through the needle shield. A second protuberance 57 is positioned distally with respect to the first protuberance and projects radially inwardly into the passageway. This second protuberance is shaped to prevent the hub from coming out of the passageway when the needle shield is removed and the syringe is used for mixing the medication and/or for injecting medication. As best illustrated in FIG. 5, a portion of the hub of needle assembly 32 can be placed between protuberances 56 and 57 to hold the hub in a predetermined, desirable, position along the passageway, before use, wherein the second cannula preferably does not contact the pierceable barrier. During use, the hub may be forced over the first protuberance so that the second cannula may pierce the pierceable barrier. Also, in this preferred embodiment the outside diameter of the inner skirt portion is slightly larger than the inside diameter of the passageway at the position of the second protuberance so that there is a frictional interference fit which helps prevent the unintentional removal of the needle shield by requiring an applied force to move the needle shield with respect to the tip portion.

The steps required for placing medication in elongate barrel 21 and sealing its flexible proximal end will be discussed in more detail hereinafter. After the barrel is filled with medication and sealed, the medication is isolated from the environment until the user causes the second cannula to pierce the pierceable barrier and establishes fluid communication between the chamber and the needle assembly. At this point, the syringe barrel and hypodermic needle assembly is ready to use for administering an injection wherein the medication may be forced out of the syringe barrel using digital pressure as illustrated in FIG. 7. If the syringe contains a dry medication in powder or lyophilized form, the diluent usually contained in a vial with a pierceable stopper, will have to be mixed with the powdered medication before administration of the injection. To do this, the syringe and barrel assembly is activated, the first cannula is inserted into a source of diluent and the barrel is digitally depressed to substantially remove the air contained therein, whereupon the removal of the digital pressure will draw the diluent into the syringe barrel for mixing. At this point, the first cannula is removed from the vial and the injection may be administered.

FIGS. 8-10 illustrate an alternative embodiment of the syringe barrel and hypodermic needle assembly of the present invention further including a plunger rod and stopper assembly. In this alternative embodiment the structure at the distal end of the barrel including the needle shield, the needle assembly and the tip portion of the barrel are substantially identical to the embodiment of FIGS. 1-7. Accordingly, substantially similar functions will be numbered identically to those components in the embodiment of FIGS. 1-7, except that a suffix "a" will be used to identify these components in FIGS. 8-10. An operable syringe barrel and hypodermic needle assembly 59 includes a barrel portion 61 having a chamber 62 for retaining fluid and a tip portion 23a having a passageway 26a therethrough. A planar web 27a extends radially outwardly from said tip portion wherein the web is substantially parallel to the longitudinal axis of the tip portion. A pierceable barrier (not shown) extends across the passageway for preventing fluid communication between the chamber and the passageway. A rigid hub (not shown) is slidably positioned within passageway 26a. A first cannula 39a extends outwardly from the forward end of the hub and a second cannula (not shown) extends outwardly from the rearward end of the hub wherein the first and the second cannula are in fluid communication.

A needle shield 46a slidably engages tip portion 23a. Needle shield 46a includes outer skirt portion 47a extending over a portion of the tip. The outer skirt portion is capable of contacting planar web portion 27a. for limiting the motion of the needle shield toward the proximal end of the barrel. The outer skirt portion also includes longitudinal groove 50a which is wider than web 27a and capable of receiving web 27a. The needle shield also includes an inner skirt portion (not shown) projecting proximally into the passageway and capable of contacting the hub. This inner skirt portion is long enough so that when the needle shield is rotated to align groove 50a with web 27a, and moved in a proximal direction with respect to the tip portion so that the web enters the groove, the inner skirt will push against the hub and move the hub in a proximal direction causing the second cannula (not shown) to pierce the pierceable barrier (not shown) establishing fluid communication between the interior of the syringe barrel and the second cannula.

In this alternative embodiment the portion of elongate barrel portion 61 defining the chamber is rigid and has the substantially circularly shaped cross section. In addition to the syringe barrel and hypodermic needle assembly, a quantity of liquid medication 64 is placed in chamber 62. A stopper 65 is slidably positioned in fluid-tight engagement inside barrel portion 61. A rigid plunger rod 67 engages stopper 65 and extends outwardly from proximal end 68 of the barrel portion. The plunger rod is accessible outside the barrel portion so that force can be applied to the plunger rod to move the stopper within the barrel to force medication through the needle assembly during the injection process.

Referring now to FIGS. 11-14, another aspect of the present invention includes a syringe barrel assembly 70 having a plurality of syringe barrels 71 each including a barrel portion 73 having a chamber 74 for retaining fluid. A tip portion 75 extends from distal end 76 of the barrel portion having a passageway 77 therethrough. The passageway is adapted to accept the hub and second cannula of a hypodermic needle assembly having a hub, a first cannula extending outwardly from a distal end of said hub and a second cannula extending outwardly from a proximal end of said hub whereas said cannula are in fluid communication. A pierceable barrier (not shown) is positioned in passageway 77 for preventing fluid communication between chamber 74 and the passageway. A plurality of planar shaped web portions 72 extend radially outwardly from the tip portions connecting the syringe barrels. It is preferred that the web portions are substantially parallel to the longitudinal axes of the tip portions. The web portions are integrally formed of the same material as the syringe barrels. The web portions and the syringe barrels are connected so that the barrels are spaced apart along a substantially straight line wherein the longitudinal axes of said syringe barrels are substantially parallel to each other. It is preferred, but not necessary, that the barrels be equally spaced from each other along the web portions.

The syringe barrel assembly contains syringe barrels which are ready for sterilization, filling and sealing. The filling operation, which will be explained in more detail hereinafter, can be performed by delivering medication through open proximal end 79 of the syringe barrel and then sealing the barrel shut by compressing the open proximal end and applying heat energy or heat producing energy or by other suitable means. Tip portion 75 of the syringe barrels is substantially identical to the tip portion in the embodiment of FIGS. 1-7. The syringe barrels re illustrated with needle shield 46a which is substantially identical to needle shield 46 in the embodiment of FIGS. 1-7 to show that a needle assembly and needle shield may be attached to the syringe barrels before filling or after filling. In filling syringe barrels, in general, it is common practice to place a number of syringe barrels in a fixture which aligns the syringe barrels and spaces them apart in a predetermined manner so that the group of syringes may be filled in a multiple head filling device wherein a plurality of nozzles deliver liquid or solid medication into a plurality of open-ended syringe barrels aligned therewith. Also, the syringe barrels, when in the fixture, may be indexed through a filling station, one at a time or a row at a time, until all barrels are filled. In some cases, the next step may be subjecting the filled syringe barrels to a lyophilization procedure to remove water from the medication. The last stop is to individually, or in a group, seal the proximal end of the syringe barrel from the environment.

The instant invention offers the advantage of providing a plurality of syringe barrels and integral web portions holding the syringe barrels in a relative position with respect to each other so that it may not be necessary to use specific fixtures or dies to carry the syringe barrels through a filling and sealing process because the web portions act as a fixture holding the syringe barrels in a predetermined spaced relationship. In an automated filling and sealing operation, the syringe barrels can be indexed through the filling and sealing stations relying on the web material to hold the relative position of the syringe barrels. Also, the present invention allows the grouping of a plurality of syringe barrels as best illustrated in FIGS. 13 and 14. Here the assemblies are nested together in rows so that the individual barrels in alternate rows are in approximate alignment with each other forming orthogonal rows and columns of syringe barrels in the alternate rows. It is preferred that the groups of nested syringe barrel assemblies be mechanically held together in their relative positions so that they may be, preferably, filled and sealed in a group. One possible method of holding the plurality of syringe barrel assemblies together is the use of known plastic shrink wrap material 81. This material will hold the syringe barrel assemblies together through the filling and sealing operation and can be cut or torn away after the syringes are filled with medication.

The instant invention offers the further advantage that a syringe barrel manufacturer can produce large quantities of syringe barrel assemblies in accordance with the present invention, shrink wrap groups of syringe barrel assemblies together, place the assemblies in a bacteria impervious package which will exclude bacteria from the contents, and sterilize said package and its contents. This sterile package of nested syringe barrel assemblies may then be sold to pharmaceutical manufacturers or hospitals for filling with medication and sealing. It will be apparent to one skilled in the art that there are many possibilities for placing syringe barrels along webs in equal or unequal spacing positions and for joining adjacent rows of syringe barrel assemblies so that they nest or rest in some other tangential relationship with each other and that the equally spaced syringe barrels nested as illustrated in FIG. 14, is exemplary of these many possibilities. It is also within the purview of the present invention to include a substantially long web syringe barrel assembly, containing several hundred syringe barrels, wherein the web and syringe barrel assemblies are rolled in coils for feeding into filling and sealing devices along a straight line.

Adverting to FIG. 15, in another embodiment of the present invention, a syringe barrel assembly 85 includes a plurality of thermoplastic syringe barrels 86 each including a rigid cylindrical barrel portion 87 having an open proximal end 88 and a chamber 89 for retaining fluid. A tip portion 91 extends from distal end 92 of the barrel portion and includes a passageway 93 therethrough. Pierceable barrier means is provided for sealing each of the passageways so that fluid cannot leave the chamber therethrough. In this embodiment a pierceable barrier (not shown) is positioned in each of the passageways. The barrier may be pierced by a dual pointed needle assembly as taught hereinabove. A plurality of web portions 94 between the syringe barrels connects the syringe barrels. The web portions are integrally formed from the same thermoplastic material as the syringe barrels. The web portions and the syringe barrels are connected so that the syringe barrels are spaced apart from each other along a substantially straight line wherein the longitudinal axes of the syringe barrels are substantially parallel to each other. The syringe barrel assembly of the present embodiment may be used in conjunction with the dual cannula needle assembly and needle shield of FIGS. 1-7 wherein this needle shield is shown in phantom lines and indicated as 46a in FIG. 15.

After filling the syringe barrels with medication and sealing the proximal end of the barrels, the barrels may be separated by shearing the web portion between adjacent barrels. The web portion may be sheared so that substantially most of it is discarded or partially removed, such as in the embodiments of FIGS. 1-7 wherein the remaining portion of the web acts as a structure which interacts with the needle shield to help prevent inadvertent piercing of the barrier. The web may be sheared in a press using spaced dies, or with a hot wire or other suitable means.

FIG. 16 illustrates an operable container and needle assembly of the present invention wherein a portion of the container body defining the chamber is made of flexible sheet material. In this embodiment and in the embodiment of FIG. 17, the structure at the distal end of the body container body portion including the needle shield, the needle assembly and the tip portion of the container body portion are substantially identical to the embodiments of FIGS. 1-7. Accordingly, substantially similar components performing substantially similar functions will be numbered identically to those components in the embodiment of FIGS. 1-7, except that a suffix "b" will be used to identify these components in FIGS. 16 and 17.

An operable container and needle assembly 100 includes a container body portion 101 having a proximal end 103, a distal end 104 and a side wall 105 therebetween defining a chamber 107 for retaining fluid 109. A tip portion 23b extends from distal end 104 having a passageway (not shown) therethrough. A projection in the form of a planar web 27b extends outwardly from the tip portion wherein, in this embodiment, the web is desirably positioned substantially parallel with respect to the longitudinal axis 29b of the tip portion. A pierceable barrier (not shown) extends across the passageway for preventing fluid communication between chamber 107 and the passageway. A rigid hub (not shown) is slidably positioned within the passageway. A first cannula (not shown) extends outwardly from the forward end of the hub and a second cannula (not shown) extends outwardly from the rearward end of the hub wherein the first and second cannula are in fluid communication.

A needle shield 46b slidably engages tip portion 23b. Needle shield 46b includes outer skirt portion 47b extending over a portion of the tip. The outer skirt portion is capable of contacting planar web portion 27b for limiting the motion of the needle shield toward the proximal end of the barrel. The outer skirt portion also includes longitudinal groove 50b. which is wider than web 27b and capable of receiving web 27b. The needle shield also includes an inner skirt portion (not shown) projecting proximally into the passageway and capable of contacting the hub. This inner skirt portion is long enough so that when the needle shield is rotated to align groove 50b with web 27b and moved in a proximal direction with respect to the tip portion so that the web enters the groove, the inner skirt will push against the hub and move the hub in a proximal direction causing the second cannula to pierce the pierceable barrier (not shown) establishing fluid communication between chamber 107 and the second cannula.

In this embodiment the container body portion 101 is made of flexible thermoplastic film capable of deformation under atmospheric pressure. In this embodiment the flexible bag shaped body portion 101 includes as part of its structure boss 110 to which the thermoplastic film is heat sealed or attached by other suitable means such as ultrasonic welding, adhesive and the like. This embodiment also includes hangar tab 111 having hangar tab aperture 113 therein. The hangar tab is useful for suspending the container and needle assembly 100 from an apparatus such as an I.V. pole so that it may interact with the "Y" site of an intravenous therapy set-up after piercing the pierceable barrier of the "Y" site and establishing fluid communication with the chamber as described hereinabove. The needle assembly of the instant invention is ideally suited for containers useful in I.V. therapy because it allows the isolation of the parenteral fluids before the time of use. It is also within the purview of the instant invention to include a container and needle assembly where only a portion of the container body portion, for example, at the proximal end, distal end and/or side wall or portions of these elements are made of flexible material which deforms under atmospheric pressure so that after establishing fluid communication between the chamber and the second cannula atmospheric pressure will cause the flexible portion to collapse as the parenteral fluid leaves the container and needle assembly.

It is also within the purview of the present invention to include an embodiment wherein a flexible tube, such as known and available vinyl tubing, is positioned between tip portion 23b and container body portion 101, for example, between the tip and boss 110. This flexible tube includes a bore therethrough for establishing fluid communication between the chamber and the tip passageway. This embodiment is ideally suited for intravenous therapy set-ups because the container body portion may now be positioned a predetermined distance from the tip portion. Also, because the tube is flexible the container body portion may now be elevated with respect to the tip portion to affect the elevation head and, accordingly, the delivery rate of the intravenous parenteral fluid.

Adverting now to FIG. 17 a container and needle assembly 115 includes a container body portion 116 having a proximal end 117, a distal end 119 and a side wall 121 therebetween defining a chamber 122 for retaining fluid. A tip portion 23b extends from the distal end of the body portion and includes a passageway (not shown) therethrough. A projection 27b extends outwardly from the tip portion. This embodiment also includes a pierceable barrier, a rigid hub, a first cannula and a second cannula as described for the embodiments of FIGS. 1-7 and FIG. 16. A needle shield 46b slidably engages the tip covering the first cannula. The needle shield includes an outer skirt portion 47b extending over a portion of the tip. The needle shield functions in the same manner as the needle shield of FIGS. 1-7 and FIG. 16. This embodiment differs from the embodiment of FIG. 16 in that the container body portion is rigid. This embodiment also preferably includes vent means having aperture 123 in proximal end 117 and hollow tube 124, connected or integrally formed with proximal end 117, so that there is fluid communication between the environment and the chamber through aperture 123 and the interior of hollow tube 124. The vent means in this embodiment will allow fluid to drain from the rigid container more readily because as the fluid leaves the chamber gases or air from the environment will enter the hollow tube to replace the displaced volume of liquid so that the flow of liquid through the needle cannula is not inhibited by subatmospheric pressures within the chamber. While not in use, hollow tube 124 may be sealed by resilient tip cap 125 to prevent contamination of the contents. It will be apparent to one skilled in the art that numerous venting structures such as air-permeable, liquid-impermeable membranes, mechanical or float valves and the like may be used as venting means for the container and needle assembly of the instant invention all of which are within the purview of the present invention. It is also within the purview of the instant invention to provide a pierceable septum in the container so that air may be injected into the container pressurizing its contents to facilitate their delivery of liquid through the needle cannula.

The syringe barrel/container of the present invention may be constructed of thermoplastic material such as polypropylene and polyethylene. For embodiments where the barrel portion and the proximal end of the barrel are flexible it will be necessary to form the syringe barrel of substantially thinner sections of material to provide the flexibility necessary. When the container is made of flexible material, plastic sheet such as polyethylene is desirable. A wide variety of materials are suitable for the stopper with natural rubber and butyl rubber being preferred. A wide variety of rigid materials are suitable for the plunger rod with thermoplastic materials such as polypropylene, polyethylene and polystyrene being preferred. A wide variety of rigid materials are suitable for constructing the hub, for use in the needle assembly, with thermoplastic materials such as polypropylene and polyethylene being preferred. It is preferred that the first cannula and the second cannula be formed of medical grade stainless steel. However, it is possible to form the hub and the second cannula out of one-piece thermoplastic material such as ABS, polypropylene or polyethylene. It may also be desirable to apply a medical grade lubricant, such as medical grade silicone lubricant, to the outside of the first cannula to reduce the force required for the cannula to penetrate the patient's flesh, a wide stopper, or I.V. "Y" site. It is preferred that all elements of the syringe barrel/container and hypodermic needle assembly, and the syringe barrel assembly of the instant invention be sterile when used. Accordingly, materials should be selected for compatibility with the sterilization process being used.

Thus, it can be seen that the present invention provides a simple, straight-forward, reliable, easily fabricated syringe barrel/container and hypodermic needle assembly, and the syringe barrel assembly of the instant invention be sterile when used. Accordingly, materials should be selected for compatibility with the sterilization process being used.

Thus, it can be seen that the present invention provides a simple, straight-forward, reliable, easily fabricated syringe barrel/container and hypodermic needle assembly for the storage and administration of medication, wherein the structure of the syringe barrel/container and hypodermic needle assembly effectively isolates the hypodermic needle cannula from the medication before the time of use and the syringe is easily activated intentionally while being difficult to activate inadvertently. Another aspect of the instant invention provides a syringe barrel/container assembly which holds and orients the syringe barrels with respect to each other in order to eliminate the need for additional fixturing during prefilling and sealing operations.