Method and apparatus for loading syringes without the need for hypodermic needles

A needleless dosage transfer system for filling medicating devices such as syringes or needleless cannulas to minimize the likelihood of an unwanted needle stick and to avoid the initial cost of a needle as well as the disposal cost of the needle. A vial has a body portion (20) formed with flexibly deformable walls and defines a blind bore. An opening of the vial includes a tapered section adapted to frictionally fit over a taper of a male luer-type fitting commonly found on syringes and needleless cannulas. By deforming the walls of the vial, fluid is forced from the vial into a syringe. The opening of the vial (10) is protected with a cap and includes a scoreline which, when fractured, defines the opening. The cap to be removed from the vial prior to its use is fabricated as one piece with the vial in order to assure sterile conditions during manufacture and filling. A tab is associated with the cap which lists the ingredients within the vial. The vial also supports an area which lists the vial's contents. The cap is structured with a coupling so that after its removal from the vial, it can frictionally engage the luer opening of the syringe or cannula. The tab provides indicia thereon as to the contents within the thus loaded syringe and to temporarily seal the syringe or cannula.

FIELD OF THE INVENTION 
The following invention relates generally to a method and apparatus for 
transferring fluid from an ampule or vial into a syringe or cannula 
without the need for a needle. More specifically, a male and female 
docking arrangement is disclosed coupled with structure for storing and 
transferring liquids so that the number of times needles are used in a 
medicating situation is kept to a minimum. 
BACKGROUND OF THE INVENTION 
Diseases such as hepatitis and AIDS, which are pathogens that can be 
transmitted with the body fluids of a person, are running rampant 
globally. As a result, medical environments such as hospitals spend 
considerable amounts of money, time and energy attending to the problems 
that arise when hypodermic needles are required. 
Complex protocols are evolving which attempt to minimize the likelihood of 
a needle stick from the time that a needle has been removed from its 
sterile storage environment through loading, utilization and disposal. 
Examples of heightened care with respect to the use of hypodermic needles 
are chronicled in patent literature, in the development of anti-stick 
needle caps, devices which destroy the needle itself after use and other 
instrumentalities for receiving both the used needle and syringe for safe 
disposal. Thus, the prevailing systems are based on the premise of the 
very existence of the needle for the medicating process. 
The instant invention to a large extent obviates the need for the needles 
themselves in the many common instances where syringe needles have 
heretofore been used. Typically, one scenario where the use of a 
hypodermic needle is now commonplace includes the steps immediately prior 
to injection in the patient. The process involves loading the syringe with 
a sterile, pharmaceutical-grade fluid by extracting medicating fluid from 
a vial by using the needle of a syringe for access. When using an ampule, 
the tip is broken off and then the ampule is entered with a needle, often 
a filtered needle to filter out glass particles. Next, penetrating the 
skin of the patient who is to receive this medicating fluid is sometimes 
performed with the same, or another new, needle. 
Prior art drug containing vials are formed from an open mouthed bottle or 
jar wherein the walls of the container defining the vial are rigid and 
non-flexible. The opening of the jar includes a lip which supports a metal 
ferrule which supports an elastomeric diaphragm made from a rubber-type 
material having a resealable property such that once the diaphragm has 
been penetrated by a needle and then removed, the diaphragm reseals 
itself. Examples of these devices are believed to be presently classified 
in class 604, subclass 415. Typically, a syringe body is first fitted with 
a hypodermic needle. It is common practice that prior to the needle being 
plunged into the vial through the rubber diaphragm, it is first loaded 
with air. Because the prior art vials are rigid, the vial is first 
pressurized to assist in fluid withdrawal. While this technique makes it 
easier to withdraw fluid, it introduces non-sterile air into the vial. 
Technically, the needle is to then be replaced with a new needle for 
injecting a patient. 
The syringe is, in general, an elongate cylindrical object having a plunger 
adapted to reciprocate within an interior hollow. By withdrawing the 
plunger from the interior of the cylindrical hollow, fluid is drawn from 
the vial and is loaded into the syringe. Once the syringe has been removed 
from the vial, great care must be exercised for a multiplicity of reasons. 
The medication contained within the syringe is now provided with the 
present ability to discharge the medication to any who come in contact 
with the needle, albeit inadvertently. In order to reduce the amount of 
time a "loaded" syringe is carried, the medicating healthcare 
professionals normally will use a cart which contains all pharmaceuticals 
which are to be distributed during rounds to the patients. This reduces 
the amount of time the healthcare professional is required to walk with an 
armed syringe whose needle has been exposed or whose exposed needle has 
been recapped. Recapping provides further risk of self sticking due to 
misaligning a needle cap with the syringe. 
After dispensing the medicine to the patient, the healthcare professional 
typically has one of several choices, none of which is entirely 
satisfactory for safe disposal of the needle. In one scenario, the 
healthcare professional is required to carefully recap the needle hoping 
that in the multiple times this procedure is reperformed he or she does 
not misalign the cap with the needle and inadvertently stiffer a needle 
stick. 
Another device has been developed which appears like a pencil sharpener and 
allows the healthcare professional to place the leading end of the syringe 
into an opening where an electric current is applied to the needle which 
melts the needle. 
A third strategy involves discarding the needle and the syringe in a 
container for subsequent destruction or internment as biomedical waste. 
This technique presents ongoing risk to people who subsequently handle 
this waste. 
The Food and Drug Administration (FDA) has accordingly issued an alert 
urging hospitals to use needleless systems or recessed needle systems 
instead of hypodermic needles for accessing Intravenous lines. Plastic 
cannulas now exist which can fit onto luer connections and penetrate 
sealable diaphragms on infusion catheters. Thus, the FDA is urging the use 
of hypodermic needles only to penetrate the skin. 
SUMMARY OF THE INVENTION 
The instant invention completely avoids the use of a needle when loading 
the syringe by extracting fluid from a vial or ampule. In its essence, the 
instant invention takes advantage of a coupling that is the standard on a 
majority of syringes which had heretofore only been used in the past to 
support the hypodermic needle on the syringe. This coupling, called a luer 
fitting, has a male component and a female component. Typically, the 
syringe is configured with the "male" luer coupling which appears as a 
truncated cone that has an opening at its narrowest cross section. The 
luer coupling diverges toward an interior cylindrical hollow portion of 
the syringe. The instant invention replaces the "female" luer coupling and 
associated needle itself and instead replicates the female coupling on a 
specially formed ampule or vial so that docking between the ampule and a 
needleless syringe benefits from the pre-existing male coupling already 
found on common syringes. Walls of the ampule or vial are flexible to 
promote removal of the fluid therewithin. 
With an opening of the ampule and the opening of the syringe in 
face-to-face docking registry and in fluidic communication, the ampule can 
be evacuated by any of a combination of manipulative steps. First, assume 
the syringe is in its initialized state, with its plunger nested well 
within the cylindrical hollow of the syringe body so that the plunger is 
in a compact, retracted state. The contents of the ampule can then be 
transferred with a minimal amount of air into the syringe by deforming the 
side walls of the ampule and "milking" (i.e. applying hydrostatic force 
to) the liquid from the ampule and thus into the syringe. This causes the 
plunger of the syringe to translate outside the cylindrical hollow. As the 
plunger advances out of the cylindrical hollow, liquid enters the syringe. 
Another strategy involves manipulation of the plunger to draw the fluid 
from the ampule by suction so that the arming of the syringe occurs by 
retracting the plunger to extract the liquid from the ampule. As before, 
the plunger starts well within the syringe and reciprocates outwardly of 
the cylindrical hollow. 
A third strategy is a hybrid of the two previously discussed techniques 
which involves manipulation of both the ampule by squeezing the ampule and 
suction by moving the plunger out of the syringe cylindrical hollow. 
Thereafter, in all cases the ampule is disconnected from the syringe. 
Once the ampule has been removed, a syringe has the intended fluid 
medication disposed therewithin. Unlike the prior art, no needle has yet 
been involved. Also, no air from the ambient environment has been mixed 
with the sterile fluid as was the case with rigid wall vials. 
In one form of the invention, it is contemplated that the opening 
associated with the ampule is provided with a removeable cap having a 
luer-type coupling and an indicia bearing tab. The medicinal contents of 
the ampule is stamped on the tab for identification purposes. With such an 
arrangement, it is possible to transfer the cap and tab from the ampule 
and connect the cap to the syringe to provide a tell tale of the contents 
of the fluid contained within the syringe. As an alternative, the ampule 
could remain docked to the syringe until subsequent use. The ampule would 
also note the contents on a surface thereof. 
As a result of this system, the entire process for filling a syringe has 
been accomplished without the use of a needle. Personnel are able to 
operate more quickly with less fear of either inadvertent needle stick or 
inadvertent exposure to the medicine contained within the syringe. 
It is to be noted that for many in-patients, the standard procedure in a 
hospital is to tap into a person's vein only once with an infusion 
catheter and to leave the catheter needle in place with tubing 
communicating therewith so that subsequent fluids such as intravenous 
drips and the like can be used. With such a system, a needle would never 
be needed with the syringe according to the present invention. "Y" 
connectors are well known in the art, one branch of which would have a 
complemental female luer coupling. Thus, for a patient's entire stay at a 
hospital, the only needle associated with that one patient, ideally, would 
be the one which initially had been placed in the patient's vein to 
support the infusion catheter. In this way, the opportunity for 
inadvertent needle sticks would be reduced to a minimum. 
OBJECTS OF THE INVENTION 
Accordingly, it is a primary object of the present invention to provide a 
method and apparatus for transferring sterile fluid from an ampule to a 
hypodermic syringe without the need of a hypodermic needle. 
It is a further object of the present invention to provide a device and 
method as characterized above which reduces the amount of time which 
hospital staff must spend in transferring fluid from a sterile ampule to a 
hypodermic syringe while also eliminating the fear of an inadvertent 
needle stick thereby avoiding the possibility of both unwanted 
contamination and unwanted medication. 
A further object of the present invention contemplates providing a device 
and method as characterized above which is extremely inexpensive to 
fabricate, safe to use and lends itself to mass production techniques. 
A further object of the present invention is to provide a device which can 
reduce the number of times that needles are required in a hospital or 
other medical setting. 
A further object of the present invention contemplates providing a device 
and method which minimizes the disposal problems of hypodermic syringes 
with needles. 
A further object of the present invention contemplates providing a device 
and method for use in which a telltale is associated with first the ampule 
that stores the medicine, and then the syringe so that the fluid 
transferred from the ampule and into the syringe will be known at all 
times. In this way, the chain of custody of the fluid can be more readily 
monitored. 
A further object of the present invention contemplates providing a system 
for loading syringes that obviates the need for the medicating health 
professional from having to trundle a miniature pharmacy on a cart from 
patient to patient. By pre-filling the syringes at a remote location added 
security and efficiency may be provided. 
When viewed from a first vantage point it is an object to provide a 
needleless dosage transfer system for removing a sterile fluid from a 
sealed vial to a conventional syringe. The syringe has a plunger such that 
the plunger of the syringe translates from a first position telescoped 
within an interior cylindrical hollow of the syringe to a second position 
where the plunger has been displaced from the interior hollow and replaced 
by the fluid. The vial is defined by an end, collapsible sidewalls 
extending from the end thereby defining a blind bore and having an open 
end, a coupler at the open end of the vial, and a removable cap occluding 
the open end at the coupler. The vial coupler is provided with means to 
connect to a needleless opening of the syringe to be in fluid 
communication therewith, whereby fluid can be transferred to the syringe 
from the vial without an interconnecting needle. 
Viewed from a second vantage point, it is an object to provide a method for 
transferring injectable fluids from a storage ampule or vial to a 
needleless syringe or other device using a male luer fitting. The syringe 
has a first coupling and an opening which communicates within an interior 
cylindrical hollow of the syringe so that fluid passes by the first 
coupling through the opening and into the hollow to load the syringe. The 
steps include providing a vial filled with fluid and with an outlet which 
has a second coupler defining the outlet. The vial is sealed by occluding 
the coupler outlet with a cap subsequently, removing the cap and orienting 
the first and second couplers into complemental fluid tight docking 
arrangement (so that the opening of the vial registers with the opening of 
the syringe) allows transfer of the contents of the vial to the syringe 
without the need for a traditional needle extraction system. 
Viewed from a third vantage point, it is an object to provide a method for 
forming an ampule to transfer medicine to be injected. The steps include 
forming an ampule with resilient walls so that the ampule can be 
collapsed, forming an opening on the ampule such that the opening is 
circumscribed by a coupler which is complementally fashioned to receive a 
dose administering device, filling the ampule with the medicine and 
finally capping the ampule opening. 
These and other objects were made manifest when considering the following 
detailed specification when taken into conjunction with the appended 
drawing figures.

DESCRIPTION OF PREFERRED EMBODIMENTS 
Referring to the drawings now, wherein like reference numerals refer to 
like parts throughout the various drawing figures, reference numeral 10 is 
directed to the vial or ampule according to the present invention. 
In its essence, the vial 10 is formed from two parts: a body portion 20 and 
a cap portion 40. An area of transition noted as a scoreline 30 serves as 
an area of demarcation between the cap 40 and body 20. The scoreline 30 
allows the cap 40 to be dissociated from the body 20 so that the body 20 
can dock with a syringe S as shown in FIG. 3 for filling the syringe S 
with a fluid F contained within the body 20 of the vial 10. 
More specifically, and referring to the drawings in detail, the vial 10 
includes a body 20 having an end wall 2, and a peripheral side wall 4. The 
peripheral side wall 4 has one proximal end coterminus with an outer 
periphery of the end wall 2 and extends away from the end wall 2 so that a 
blind bore 6 has been formed within which the fluid F is to be stored. As 
shown, the side wall 4 can be substantially cylindrical in shape. The end 
wall 2 can be hemispherical. Alternatively, the end wall 2 can appear as a 
fan-shaped seam 3 caused by flattening and sealing the sidewalls 4 (See 
FIG. 2). 
Typically, fluids such as a saline solution or pharmaceutical drugs and 
other medicaments can be stored within the blind bore 6. A distal end of 
the side wall 4 remote from the end wall 2 is provided with a tapering 
section 8 which converges towards a longitudinal axis L of the vial 10 
defining a converging portion of the vial 10. This tapering section 8 
converges to an opening 12, or outlet and thereafter communicates with the 
cap 40. The opening 12 defines a coupler of the vial 10. The area of 
transition where the opening 12 is located is preferably coincident with 
the scoreline 30 to facilitate fracture of the vial 10 at the opening 12. 
Thus, the cap 40 can be separated from the body 20. 
The cap 40 includes a flag type tab 42 on an exterior surface thereof upon 
which is printed the product contained within the vial 10. The tab 42 is 
shown having a substantially rectangular, planar configuration to provide 
an exposed surface sufficient to place the name of the product on the tab. 
The tab 42 also serves as a purchase area to allow a person to grasp the 
cap 40 so that a twisting motion of the cap 40 with respect to the body 20 
will cause severing of the body 20 from the cap 40 at the scoreline 30. 
The cap 40 also includes an interior passageway 44 having a diverging 
contour 38 which substantially mirrors the slope of the tapered section 8 
of the body 20 of the vial 10 about an axis of symmetry coincident with 
the scoreline 30. This diverging passageway 44 extends a short distance 
within the cap 40 for purposes to be assigned. 
As shown in FIG. 2, prior to docking with the empty syringes S (or 
needleless cannula), the cap 40 will have been removed from the body 20 of 
the vial 10. This allows the opening 12 of the body 20 to be exposed. The 
opening 12 has an inner peripheral dimension complemental to an exterior 
diameter of a male luer coupling M found on the syringe's or cannula's 
outlet. This coupling M defines an opening which forms a coupler of the 
syringe. Typically, this luer-type connection tapers and diverges as it 
approaches a cylindrical hollow H of the syringe S. 
For a friction fit, and with respect to the syringe S shown in FIG. 1, the 
taper of the luer M traditionally couples to a needle. Instead, the 
syringe docks with the vial 10 as shown in FIG. 3 such that the "male" 
conical taper of luer coupling M of the syringe S passes within the female 
opening 12 of the body 20 and becomes frictionally engaged in the tapering 
section 8 of the vial's body 20. Note that the plunger P on the syringe S 
(FIG. 3) is in a contracted position such that the syringe's cylindrical 
hollow H, located on an interior portion of the syringe S has received the 
plunger P to its entire extent and the push rod of the plunger P is in a 
position immediately adjacent to the cylindrical barrel of the syringe S. 
In other words, the syringe S is empty. 
With respect to FIG. 4, it should be noted that the side walls 4 of the 
vial 10 are formed from a material having the ability to elastically 
deform in the presence of force. In other words, the side walls 4 of the 
body of the vial 10 can collapse. In this way, fluid F contained within 
the vial 10 can be transferred into the syringe S. It is contemplated that 
one of three methods could be used to transfer the fluid F of the vial 10 
into the syringe S. 
One scenario, shown in FIG. 4, envisions the vial 10 being deformed by 
providing external force in the direction of the arrows D along the outer 
periphery of the side walls 4. This causes the incompressible fluid F to 
be forced from the vial 10 and into the syringe S. The plunger P will now 
be forced by fluidic pressure, induced from the vial 10, to move the 
plunger P from a first contracted position (FIG. 3) to a second expanded 
position (FIG. 4). The cylindrical hollow H of the syringe S receives the 
fluid F. In other words, the syringe S will now have been filled with the 
fluid F and the plunger P will have been extended to a second position for 
delivery to a patient. 
A second scenario involves docking the syringe S or needleless cannula with 
the vial 10 as described above. Rather than exerting force D on the vial 
10, instead the plunger P is pulled in the direction of the arrow A and 
causes negative pressure to exist in the cylindrical hollow H of the 
syringe S. Since the side walls 4 of the vial 10 are elastically 
deformable, the pressure induced by pulling the plunger P in the direction 
of the arrow A will cause the fluid F within the vial 10 to migrate into 
the cylindrical hollow H of the syringe S, filling the syringe S. 
A third scenario involves a hybridization of the first two mentioned 
techniques. Namely, force D on the exterior side walls 4 of the vial 10 
will be coupled in concert with pulling of the plunger P in the direction 
of the arrow A so that the incompressible fluid F will have migrated from 
the vial 10 to the syringe S. 
FIG. 5 is directed to a final manipulation of one component of the 
apparatus according to the present invention. The cap 40 has indicia 
thereon correlative to the identity of the fluid F which has now been 
transferred from the vial 10 into the syringe S. The cap 40 has an 
interior passageway 44 which is placed in axial registry with the long 
axis L of the syringe S or needleless cannula. Thus, the syringe S or 
cannula will be covered with cap 40. As mentioned above, the scoreline 30 
of the opening 12 defines an axis of symmetry between the tapering section 
8 of the vial body 20 and the diverging contour 38 of the passageway 44 of 
the cap 40. As shall now be evident, the cap 40 can be frictionally forced 
over the conical taper of the syringe S thereby covering the male luer 
coupling M. 
In this way, after the syringe S is loaded and ready for subsequent use, 
the contents of the fluid F within the syringe S will be known to the 
person dispensing the medication. Thus, different fluids can be pre-loaded 
into several syringes in a secure area. The healthcare professional can 
merely take a collection of the syringes or needleless cannulas to the 
site for ultimate medicating without having to use a drug preparation cart 
as is commonly in vogue today. The cap 40 can include a support foot 46 to 
support the syringe S or vial 10 on end. The foot 46 is located at an end 
of the cap 40 remote from passageway 44 and defines a planar surface 
transverse to the long axis 2. This allows the on end orientation of FIG. 
6. The foot 46 is preferable faceted at extremities thereof so that the 
foot 46 prevents the syringe S or vial 10 connected thereto from rolling 
when oriented as shown in FIGS. 1 and 5. 
As had been mentioned briefly hereinabove, many people residing in 
hospitals as in-patients have infusion catheters operatively coupled at 
all times during their stay. Many of the infusion catheters include a 
female luer coupling similar to the contour of both the vial 10 and the 
passageway 44 of the cap. When this is the case, the syringe S never needs 
to include a needle on the male luer coupling M. Instead, one can 
administer the medicine directly through the infusion catheter. In this 
way, the number of instances where trained medical personnel are exposed 
to administering fluids with hypodermic needles will be minimal. This 
reduces the amount of time and care required in the efficient performance 
of their tasks and minimizes both occasions for needle sticks and problems 
of needle disposal. 
Moreover, having thus described the invention, it should be apparent that 
numerous structural modifications and adaptations may be resorted to 
without departing from the scope and fair meaning of the instant invention 
as set forth hereinabove and as defined hereinbelow by the claims.