 |
Description  |
|
|
TECHNICAL FIELD
The present invention relates to an adapter which locks onto a medication
vial (MV) and provides an interface between the medication vial (MV) and a
needle-less syringe to permit filling the syringe with medication inside
of the MV without the use of a needle.
BACKGROUND OF THE INVENTION
With the increased concern about the possibility of contracting blood borne
diseases, such as AIDS and hepatitis, from accidental, self-inflicted,
needle stick injuries with a possibly contaminated needle, the health care
industry is presently concentrating on minimizing, or eliminating, the use
of needles wherever possible. The FDA has urged health care workers to
avoid re-capping of needles after using them for intravenous (IV) and
intramuscular injections. One solution to avoiding re-capping needles
after using them for IV injections is to use a needle-less IV injection
port. The use of needle-less IV injection ports has become more widespread
over the past few years. One complaint, however, when using a needle-less
IV injection port is that one must still use a needle to fill the syringe,
before it can be used with the needle-less IV injection port. A needle
used to fill a syringe is usually not infectious, but the use of a needle
here, does expose a health care worker to a potential needle stick, and
does add the extra cost of a needle. One way to avoid this potential
needle-stick, and fill a syringe without the use of a needle, is to use a
medication vial (MV) adapter.
There are a few special devices presently described which do permit filling
syringes without the use of needles (Froning et al., U.S. Pat. No.
4,505,709, Smith et al., No. 4,650,475, and Schroeder, No. 5,035,689).
There are some devices that have means for affixing themselves to a
medication vial (Forman et al., No. 4,759,756, Gilbert et al., No.
4,969,883, and Holtz, No. 4,944,736). These devices and the methods used
to attach them to a standard MV (Holtz, Froning et al., Smith et al.,
Forman et al., Schroeder) are somewhat cumbersome. Their design makes them
hard to attach their respective device to the MV, and this difficulty in
attaching them to the MV can easily lead to contamination of the device,
with loss of sterility of the device, loss of sterility of the MV, and
loss of sterility of the medication contained inside of the MV.
Other examples of related art in this field are shown in Smith, U.S. Pat.
No. 4,230,112, Parsons, U.S. Pat. No. 4,913,699, and Curley et al., U.S.
Pat. No. 4,328,802.
SUMMARY OF THE INVENTION
The present invention is an improved medication vial (MV) adapter that
locks onto a standard MV at one end, and interfaces with a standard
needle-less syringe at the opposite end, to permit filling a syringe with
medication, without the use of a needle, in a more sterile, and more
efficient manner. The adapter has a body with a detachable means on one
end, and a locking and piercing means on the opposite end. The detachable
means is for sealably connecting to the inlet of a needle-less syringe and
is centered substantially on the body, and has a central bore which
fluidically connects the adapter with the syringe. The piercing means, for
piercing the cap of the medication vial, is substantially elongated in
shape and has a longitudinal axis with a spike bore extending along the
longitudinal axis, fluidically connecting the central bore to the spike
bore. An adapter inlet is positioned along the longitudinal axis at a
distance such that the distance between the inlet and the body is only
slightly greater than the thickness of the cap of the medication vial. At
least two resilient locking attachment limbs extend from the body
substantially in the same direction as the piercing means with each limb
having a length substantially less than that of the piercing means. Angled
foot pieces are attached to the distal ends of each of the resilient
limbs. Each of the angled foot pieces has an inward and upward extending
guiding ramp portion on the outer, lower end, and a hook portion on the
opposite, inner, upper end.
DESCRIPTION OF THE DRAWINGS
FIG. 1 is an oblique view of one embodiment of the invention with a
standard type syringe attached to the outlet end, and a standard type
medication vial (MV) attached to the inlet end. The MV is affixed to the
improved MV adapter of the present invention by a spike end and resilient
attachment means.
FIG. 2 is an oblique view of one embodiment of the MV adapter of the
present invention.
FIG. 3 is a cross-sectional view of the prior art unassembled standard MV
showing the rubber sealing stopper fitting over the mouth of the standard
MV, after the MV has been filled with medication, and before the rubber
sealing stopper has been permanently attached to the glass vial by a
crimped metal band.
FIG. 4 is a top view of the prior art fully assembled top of a standard MV
showing the exposed portion of the rubber sealing stopper as accessed
through the opening in the metal band.
FIG. 5 is a side view of a fully assembled prior art standard MV with the
metal band affixing the rubber sealing stopper onto the glass mouth of the
MV, showing the neck and cylindrical body portions of the MV.
FIG. 6 is a side view of the prior art metal band as it appears after it
has been placed over the rubber sealing stopper and the glass mouth of the
standard MV, and has been crimped over the lower edge of the glass mouth
to affix the rubber sealing stopper onto the MV and form a hermetic seal.
FIG. 7 is a side view of one embodiment of the invention, showing the
reusable sterile cover cap and the medication flow path through the
syringe end, the flange, the spike end, and the fluid entry side hole, or
side holes, in the spike end.
FIG. 8 is a side view of another embodiment of the invention, showing the
presence of standard, prior art, luer locking lugs on the syringe end.
FIG. 9 is a side view of another embodiment of the invention, showing the
device built as two mating components which functions similar to the
embodiments built as one unit.
FIG. 10 is a top view of the invention without the sterile, reusable cover
cap, showing the flow channel in the syringe end, and a top view of the
resilient attachment means.
FIG. 11 is a side view of one embodiment of the invention showing its
locked-on position when affixed to the standard medication vial.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The reference numbers used in the descriptions that follow refer to
features of the invention shown in FIGS. 1 through 11.
The present invention of "an improved medication vial adapter" is used with
a hermetically sealed medication vial (MV) 13 of standard type and shape.
The MV 13 is typically made of transparent glass or plastic, and includes
a mouth 19 with a stopper 20 of rubber or elastomer type material mounted
thereupon by metal band 21. The glass mouth 19 of the MV 13 narrows down
to a neck 26 and then broadens out again to a cylindrical part 29 which
contains the sterile medication. A metal band 21 is mounted about the
mouth 19, retaining the rubber or elastomer stopper 20 to the top of the
MV 13 and forms part of the top cover of the MV 13. The metal band 21 has
a central opening 25 on its top surface which exposes the access site of
the rubber or elastomer stopper 20 as it is bound by the metal band 21 to
the glass mouth for piercing. The center of the rubber or elastomer
stopper 20 exposed in the center opening 25 of metal band 21 serves as an
access site to the sterile medication contained inside the MV.
A junction 27 is formed where the edge of the metal band 21 is crimped, and
meets the glass of the bottom side of the mouth 19 near the neck 26 of the
MV. The rubber or elastomer stopper 20 is self-sealing when a piercing
device has been inserted through it and also when the piercing device is
removed from it, provided that the diameter of the piercing device was not
too large. In addition the metal band 21 affixing the rubber or elastomer
stopper 20 to the mouth 19 has a height or thickness 23.
The improved medication vial adapter of the present invention 30 consists
of a syringe attaching end 1, a flange 2, at least two resilient
attachment limbs 3 and 3a, and a piercing spike end 4 with a central bore
7. Syringe attaching end 1 has a central bore 10, which extends through
the flange 2, and communicates with the central bore 7 of the piercing
spike end 4.
Syringe end 1 may or may not contain luer locking lugs 11 (shown in FIG. 8)
depending on which embodiment is presented. When not being used, syringe
end 1 is covered with a removable and re-usable sterile hermetic sealing
cover cap 14. Cover cap 14 preserves sterility of the syringe end 1 and
the medication contained within the attached standard MV 13. Cover cap 14
also prevents leakage of medication from inside of the standard MV 13 when
the standard MV 13 is placed on its side with the improved MV adapter 30
of the present invention attached.
The spike end 4 has a sharp pointed tip 9, a central bore 7, and a fluid
entry side hole, or side holes 8, depending upon which embodiment of the
improved MV adapter 20 of the present invention is presented.
The two resilient attachment limbs 3 and 3a of the improved MV adapter 30
of the present invention are similar in design, but are set on flange 2 as
mirror images of each other. The free ends of resilient attachment limbs 3
and 3a terminate in an angled foot piece 12. Each angled foot piece 12 of
the improved MV adapter 30 of the present invention is angled upward, and
points inward, like sides of an inverted funnel, and has a hook portion 5
on the inner, upper end, and a guiding ramp portion 6 on the outer, lower,
end.
The distance between the resilient attachment limbs 3 and 3a of the
improved MV adapter 30 of the present invention is substantially equal to
the diameter 22 of the metal top 21 of the standard medication vial 13.
The vertical distance between the lower side 17 of the flange 2 and the
upper tip 18 of hook portion 5, of angled foot piece 12, of resilient
attachment limbs 3 and 3a of the improved MV adapter 30 of the present
invention, in closest proximity to the lower side 17 of flange 2, is equal
to the height 23 of the metal top 21 of the standard medication vial 13.
The piercing spike end 4 of the improved MV adapter 30 of the present
invention is formed in the radial center of the lower side 17 of the
flange 2. The hollow syringe end 1 of the improved MV adapter 30 of the
present invention is formed at the radial center of the top surface 28 of
the flange 2 opposite the spike end 4. There is a central fluid flow
channel 7 which begins in the spike end 4 at fluid entry side hole (or
holes) 8 and passes through the radial center of flange 2, to communicate
with the central flow channel 10 in syringe end 1.
The opening hole (or holes) 8 of the medication fluid flow channel 7 in the
spike end 4 of the improved MV adapter 30 of the present invention is
placed at the level where the maximum amount of medication can be removed
from the standard medication vial 13 when the improved MV adapter 30 is
attached to the standard MV 13 by the attachment means 3 and 3a. Thus, the
distance between the opening hole (or holes) 8 of the flow channel 7 in
the spike end 4 and the lower side 17 of flange 2 of the improved MV
adapter 30 of the present invention is greater than the combined thickness
of the rubber or elastomer stopper 20 and the thickness of the top wall of
the metal top 21. In the preferred embodiment, the distance is only
slightly greater. The diameter of the bore of the central flow channel 7
through 10 varies dependent upon the diameter of the part of the improved
MV adapter 30 of the present invention that it is passing through, so that
the bore is always maximum to give the best combination of maximum fluid
flow rate and tubular wall strength.
The syringe attaching end 1 of the improved MV adapter of the present
invention 30 may or may not contain luer locking lugs 11. In the preferred
embodiment of the improved MV adapter 30 the luer locking lugs 11 are
absent. Absence of the luer locking lugs 11 makes using the improved MV
adapter 30 faster and more efficient. Without the presence of luer locking
lugs 11, needle-less syringes 15 can be quickly pushed onto, and pulled
off of, the syringe end 1 as they are being filled with medication without
the use of a needle. With the absence of the luer locking lugs 11, it is
not necessary to use the more time consuming, less efficient, method of
screwing and locking the empty syringe 15 onto, and then unscrewing and
unlocking the medication filled syringe 15 from the attaching end 1 of the
improved MV adapter 30 of the present invention.
The flange 2 of the improved MV adapter 30 is disk shaped. With the
resilient attachment means 3 and 3a, the improved MV adapter 30 of the
present invention may be made as one piece or as two separate mating
pieces. Whether it is made as one piece, or two separate mating pieces,
the improved MV adapter 30 will function the same. Once the improved MV
adapter 30 has been affixed to the standard MV 13, the flange 2
protectively shields the top of the standard MV 13 from any spilled
liquids and particulate matter falling onto the flange 2. In this manner,
flange 2 helps maintain sterility of the medication inside of the MV 13.
The removable and re-usable cover cap 14 forms a hermetic seal with, and
protects the syringe end 1 of the improved MV adapter 30 and the MV
contents from contamination of sterility. When filling a syringe 15, the
re-usable cap 14 is removed and laid aside in a sterile manner. When the
syringe 15 has been filled and removed from the improved MV adapter 30,
the cover cap 14 is replaced over the syringe end in a sterile manner.
The distance between the two upper tips 18 of hook portions 5 of the angled
foot pieces 12 of the resilient attachment limbs 3 and 3a of the improved
MV adapter 30 of the present invention is shorter than the diameter 22 of
the metal top 21 and is equal to or slightly shorter than the diameter
across the glass neck 26. The space enclosed by the lower edges 17 of the
flange 2, the inner facing edges 16 of the resilient attachment limbs 3
and 3a, and the upper tip 18 of hook portions 5 of the improved MV adapter
30 is nearly the same size as the side dimensions of the metal top 21 of
the MV 13 that the improved MV adapter 30 of the present invention
attaches to. The fairly close tolerances between these contacting surfaces
provides a firm locking attachment of the improved MV adapter 30 to the
standard MV 13.
The piercing spike 4, with its sharp pointed spike tip 9, is longer than
resilient members 3 and 3a, with their attached foot pieces 12 and their
hook portion 5, and guiding ramp portion 6. Because the sharp pointed
spike tip 9 of the piercing spike 4 extends beyond the level of the
resilient attachment limbs (3, 3a, 5 and 6), when the improved MV adapter
30 of the present invention is inserted into the rubber or elastomer
stopper 20 exposed by the center hole 25 in the metal top 21 of the
standard MV 13, the sharp pointed spike tip 9, of the piercing spike 4,
engages and pierces the rubber or elastomer stopper 20 of the standard MV
13 first. This initial piercing of the rubber or elastomer stopper 20 by
the leading spike tip 9 of the improved MV adapter 30 of the present
invention stabilizes the improved MV adapter 30 onto the metal top 21
before the shorter diameter between the two hook portions 5 of the angled
foot pieces 12 of the resilient attaching means 3 and 3a encounters the
larger diameter 22 of the metal band 21 on the top rim of metal band 21 of
the top of the standard MV 13.
When attaching the improved MV adapter 30 of the present invention to the
standard MV 13, the MV adapter 30 will have the re-usable cover cap 14
attached to the syringe end 1. The improved MV adapter 30 of the present
invention is held with the fingers holding onto the cover cap 14 and
resting against the upper flat surface 28 of flange 2. As the fingers grip
the cover cap 14 attached to syringe end 1, and push forward against the
flat surface 28 of the flange 2, the sharp pointed spike tip 9 of the
piercing spike 4 is placed at the exposed radial center of the self
sealing rubber or elastomer stopper 20 of the standard MV 13. As the MV
adapter 30 is pushed further forward, the sharp pointed spike tip 9 of the
piercing spike 4 pierces the center of the self sealing rubber or
elastomer stopper 20 of the top of the standard MV 13. The entry of the
sharp pointed spike tip 9 of the piercing spike 4 into the rubber or
elastomer sealing top 20 of the standard MV 13 stabilizes the improved MV
adapter 30 in the center of the self sealing rubber or elastomer stopper
20 of the standard MV 13. This prevents any tendency for the MV adapter 30
of the present invention to slip around the metal top 21 of the standard
MV 13 and become contaminated. As the spike 4 of the improved MV adapter
30 of the present invention is pushed further into the rubber stopper 20,
the MV adapter 30 remains stabilized in the center of the rubber or
elastomer stopper 20 of the standard MV 13, not tending to slip off to one
side and contaminate sterility of the attaching components. With further
pushing forward of the improved MV adapter 30 of the present invention
into, and onto the standard MV 13, the inverted funnel shaped guiding ramp
portions 6 of the angled foot piece 12 of the resilient attachment means 3
and 3a contact the diameter 22 of metal top 21 of the standard MV 13 and
guide it straight, in the axial direction of the piercing spike 4.
The resilient attachment limbs 3 and 3a flex outward away from the upper
corners 31 of the metal top 21 of the MV 13 because of the lateral vector
force exerted on them by the pushing pressure from the outward angle of
the guiding ramp portion 6 of the angled foot piece 12. This outward
flexing of the resilient attachment limbs 3 and 3a, caused by the lateral
vector force, continues as the improved MV adapter 30 of the present
invention is pushed farther onto the MV 13, until the hook portions 5 of
the angled foot pieces 12 are spread to a distance equal to the diameter
22 of the metal top 21 of the standard MV 13.
Further pushing forward of the improved MV adapter 30 of the present
invention, with the spike end 4 advancing further into the rubber or
elastomer stopper 20, with the hook portions 5 spread apart the distance
equal to the diameter 22 of the metal top 21 of the standard MV 13, causes
the upper tips 18 of hook portions 5 to resiliently slip beneath the lower
edge of the metal cap 21, firmly grip, and thus permanently attach the
improved MV adapter 30 of the present invention to the standard MV 13 with
the upper tips 18 of the hook portion 5 of the angled foot pieces 12
firmly gripping the corner junctions 27 where the metal band 21 crimp
meets the underside of glass mouth 19 near the neck 26.
Because the improved MV adapter 30 is initially fixed to the center of the
rubber stopper 20 on the standard MV 13 by the leading piercing tip 9 of
piercing spike 4, there is no slipping of the improved MV adapter 30 of
the present invention on or around the metal top 21 of the standard MV 13
as the resilient attaching limbs 3 and 3a and angled foot pieces 12 with
guiding ramp portions 6 flex outward, slip over, and lock onto the metal
top 21 of the standard MV 13 by the hook portions 5 of the angled foot
pieces 12. The initial fixation in the center of the rubber stopper 20 of
the improved MV adapter 30 by the forward extending sharp pointed tip 9 of
the piercing spike 4 combined with resultant lateral vector forces on the
guiding ramps 6 of the angled foot pieces 12 attached to the resilient
attachment limbs 3 and 3a guiding and pushing the hook portions 5 of the
angled foot pieces 12 of the resilient attachment limbs 3 and 3a onto the
sides and to the undersurface of the MV 13 produces an easy, safe,
accurate and sterile method to permanently attach the improved MV adapter
30 of the present invention to a standard MV 13. Thus, when using the MV
adapter 30 of the present invention, there is less chance of contaminating
the MV adapter 30 itself, the rubber or elastomer stopper 20, the top of
the standard MV 13, and the sterile medication contained inside of the
standard MV 13. This represents an easier, safer, more accurate, and more
sterile method of attaching a MV adapter to a standard medication vial 13.
Because the distance between the hook portions 5 of the angled foot pieces
12 at the ends of resilient attachment limbs 3 and 3a, of the improved MV
adapter 30 is shorter than the diameter 22 of the metal top 21 of the
standard MV 13 that it is to be attached to, without the presence of the
outward extending guiding ramp portions 6 of the angled foot pieces 12 it
will be difficult to attach such a MV adapter (such as with Holtz, Curley
et al., and Forman et al.) to the standard MV 13. An adapter without the
inverted funnel design of the guiding ramp portions 6 of the angled foot
pieces 12, or the initial stabilization feature provided by the leading
piercing spike end 4 with its sharp pointed spike tip 9 being longer than
the resilient attachment limbs 3 and 3a, will tend to slip to one side or
slide around the top of the standard MV 13 as one attempts to attach and
affix it permanently to a standard MV 13. This instability and slipping
can result in loss of sterility of the joining parts, from finger
contamination or rubbing against a non-sterile portion of the standard MV
13.
Because the sharp pointed tip 9 of the spike 4 has a symmetrical conical
shape instead of a slanted angular tip as in piercing needles of much of
the prior art, it is easier to insert the spike 4 in the center of the
rubber or elastomer sealing stopper 20 and push the spike 4 straight
through without it wandering off center. Also, because the spike bore 7
communicates with the inside of the standard MV 13 through the side
hole(s) 8, there is no tendency for the spike to core or cut off a piece
of the rubber or elastomer stopper 20 as it is being inserted into the
standard MV 13 as may occur with the angular end bore design of piercing
needles of much of the prior art. A dislodged piece of the rubber or
elastomer stopper 20 may clog the needle, drop into and contaminate the
medicine inside the MV 13, or worse yet, get drawn with the medicine, into
the syringe 15 and then be injected into the blood stream of a patient.
The distance between the farthest ends of the guiding ramp portions 6 of
the angled foot piece 12 of the end of resilient attachment limbs 3 and 3a
is substantially greater than the diameter 22 of the metal top 21 of the
standard MV 13 to which the improved MV adapter of the present invention
30 is being attached to. Guiding ramp portion 6 of each angled foot piece
12 is angled upward and points inward like sides of an inverted funnel.
When the upward and inward angled foot pieces 12 with the guiding ramp
portions 6 and the hook portions 5 are lowered over the smaller diameter
22 of the metal top 21, the inverted funnel-shaped guiding ramp portions 6
cover beyond the full diameter 22 of the MV 13 and guide the hook portions
5 over the metal top 21 to permit them to permanently attach and lock the
improved MV adapter 30 of the present invention onto the MV 13. The
lateral vector force resulting from the downward push on the angled foot
pieces 12 pushes the hook portions 5 outward. The downward vector force
pushes the hook portions 5 downwards past the upper outer corner 31 of the
metal top 21, down the sides of the metal top 21 of the standard MV 13,
and then past the lower outer corner 32 of the metal top 21. The resilient
members 3 and 3a bring the hook portions 5 and their upper tip portions 18
back, under and into the lower inner corner 27 of the top of the MV 13,
where the metal top 21 of the standard MV 13 ends at the glass neck 26 of
the standard MV 13. The hook portions 5 now permanently lock the improved
MV adapter 30 of the present invention onto the standard MV 13 below the
metal top 21 at the point 27 near the point where the lower inner end of
the metal top 21 and the glass neck 26 approach each other.
The final location of the hook portions 5 at the point 27 below the metal
top 21 of the standard MV 13 makes a permanent attachment to the standard
MV 13, the resiliency of the attachment limbs 3 and 3a prevents the
improved MV adapter of the present invention from coming off of the
attached standard MV 13 when the medication filled syringe 15 is pulled
off. The permanent attachment of the improved MV adapter 30 of the present
invention to the standard MV 13, permits faster and more efficient filling
of syringes 15 without the use of needles, and it helps preserve sterility
of both the improved adapter of the present invention 30 and sterility of
the contents of the medication vial 13. In contrast to using a MV adapter
that does not have permanent attachment means (Smith et al., Froning et
al.), when using the improved MV adapter of the present invention 30, one
does not have to make a special effort to hold the improved MV adapter 30
at the top surface 28 of the flange 2 and simultaneously hold lower
surface 17 of the flange 2 against the top surface of the metal top 21 of
the standard MV 13 in order to prevent the MV adapter from being pulled
off with the syringe 15 when the medication filled syringe 15 is pulled
of. The resilient attachment means 3 and 3a will hold the improved MV
adapter 30 of the present invention onto the standard MV 13. One may now
hold the standard MV 13 at any convenient location when pulling the
medication filled syringe off of the improved MV adapter of the present
invention 30 without having concern that it will come off of the standard
MV 13 and become contaminated. In the case of an adapter without
attachment means, if the adapter comes off with the syringe 15, and it is
subsequently pushed back onto the standard MV 13, loss of sterility of
both the MV adapter and the contents of the medication vial can occur.
The unique combination of the sharp pointed tip 9 of the piercing spike 4
of the improved MV adapter 30 of the present invention being longer, or
extending further forward, than the resilient attachment limbs 3 and 3a,
the resiliency of the attachment limbs 3 and 3a, and the design of the
resilient attachment limbs 3 and 3a with their metal-top-encompassing
angled foot pieces 12 with their guiding ramp portions 6 and their hook
portions 5, permits the improved MV adapter 30 of the present invention to
be attached to a standard MV 13 in a manner which is easier, more
accurate, safer, and more sterile. Once the improved MV adapter 30 of the
present invention has been permanently attached to the standard MV by this
improved attachment method, it permits filling standard syringes 15
without the use of needles, with sterile medication from a standard MV 13,
in a manner which is easier, faster, more efficient, and most importantly,
more sterile.
It is to be understood that the present invention is not limited to the
sole embodiments described above, but encompasses any and all variations
falling within the scope of the appended claims.
* * * * *
|
|
 |
|
 |
Description |
|
