Note: Descriptions are shown in the official language in which they were submitted.
~Q379~
; Many medicaments are prepared, stored and supplied in dry or lyop-
hilized form. Such medicaments must be reconstituted at the time of use by
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the addition of a diluent thereto. ~arious ~ethods of adding the diluent to
the dry or lyophil~zed med~cament have ~een used. One method in common use ~`
is the "open-pour" technique in which the diluent, such as a bottle of in~
travenous solution, is opened and some of the contents poured into the vial
or bottle containing the dry or lyophilized material. After reconstitution, -
the liquid is usually returned to the intravenous solution bottle or vial,
or other source of diluent. Thi5 techni~ue is unsatisfactory because both
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the dry or lyophilized material and the diluent are exposed to ambient air-
borne bacterial contamination.
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~i Another procedure is the "intravenous set transfer" technique which
requires not only an intravenous solution set and stand, but also a needle
; or venting or a special dispensing cap.
,~ It is also possible to accomplish reconstitution using an ordinary
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syringe to transfer diluent into the container for the dry or lyophilized
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"1 material. In this operation, the needle is exposed to constant airborne
~' contamination.
.1 The present invention is concerned with solving and avoiding the
problems~associated with~the prior art. It is to be expected that this in~
~- vention~will be rapidl~ adapted ~r hospitals~ i
Briefl~, the present in~ention consists of a fluid transfer device
comprising t~o parallel ~luid passages ~ithin a single elon~ated rigid member
having open cutt~ng ends~ said rigid member being carried by a generally `
disk~like flange disposed midway between the ends of said rigid member which
! is generally perpendicular to said passages, the improvement wherein said
passages are of equal length and the two open ends of said passages on each
1 side of said flanges are longitudinally displaced from one another, and
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1 urther wherein said rigid member is provided with at least one lateral air
i 3~ hole in one of said passages and, on the opposite of said flange, tfle other
of said passages is provided with at least one lateral hole to prevent the
formation of fluid slug~
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A comm~n coyer can ~e ~rov~ded for one end of each fluid passage, ~;~
. sa~d coyer forming a fluid tight seal w~th:the exterior of said passages and
abutting said flange.
. One preferred embodiment of the device includes. a medicament con-
: tainer having an open end and an imperforate rubber stopper in said open end
which seals said container. One end of each of said fluid passages is
. adapted to pierce said stopper with.said flange abutting the exterior of .
said stopper. The cover seals the interior of said container against con- ,
tamination. .
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In the drawings:
~igure 1 is a perspective view of one embodiment of the transfer
' devlce of my inventlon;
.~1 Figure 2 is an end view of the dovice of Figure 1;
Pigure 3 is a sido sectional view along the lino 3-3 o~ ~igure 2;
, 'igure 4 is a perspective view of another embodiment of this .-
.;1 invention;
~ Figure S is a side sectional view of the device of Figure 4;
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.~ Figure 6 is a perspective view of the transfer device of Figures
... 1 _ 5 with the cover remof~ed;
~ 20 Figure ~ is a~sectional view o another embodiment of the invention; ~. ~
'j$;~,' Pigure 8 is~a perspective ~f~ew of the embodiment; .; :: -
::.:. ~igure 9 ~s a pe~specti~e view~showing the first step in the use i.
of the transfer device w~th a diluent bottle or vial;
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Figure 10 is a perspective view showing the next step in the use
~ of the transfer device; :. :
`~ Figure 11 is a perspective view of the next step in the use of the ~.. : ~;
. transfer device to transfer fluid between medicament containers; . .~::
i Figure 12 is a side sectional view of the transfer device in place
between two medicament containers, and operating to transfer liquid from the
' upper bottle to the lower bottle; ~. .
,~. Figure 13 shows in perspective view the embodiment of the cover of . . -
,
Figures 4 and 5 on the transfer device at the beginning of use with a diluant
; bottle or vial;
Pigure 14 shows the next step in sequence with the transf0r devic
fully inserted into the stoppered opening o:F a diluent bottlc or vial; .;
Figure lS is a side sectiona} view showing the operation of thc
'J,:' apparatus of Figures 13 and 14 wherein liquid medication is being added to ..
the diluent bottle or vial through the cover and transfer device. .~.
Figure 16, which appears on the second page of drawingsJ is a side ~,
;:l sectional view showing the operation of the transfer device of Figures 7 and -.
8 wherein liquid medication is being added to the diluent bottle or vial .
through the cover and transfer device. .:
Figure l' is a perspective view of one embodiment of the transfer
device of my invention;
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Figure 2' is an end view of the device of Figure l';
: Figure 3' is a side sectional view along the line 3-3 of Figure 2';
Figure 4' is a perspective view of another embodiment of the ~rans-
fer device of this invention; `. .;
~¦ Figure S' is an end view of the device of Figure 4'; ~:
; Figure 6' is a sectional view taken along the line 5-5 o Figure
5';
~ Pigure 7',which appears on the fifth page of drawings, is a perspec-
tive view showing the device of Figure 1' with a protective cover thereover;
Figure 8' is a perspective view of the device of Figure 4' with
the protective cover shown in Figure 7'; ~ :
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~ Figure 9' shows the initial step on the use of the transfer device ~
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of Pigur~s 1' - 3' and 7';
Figure 10' shows the next step;
~ Figure 11' shows the next step in sequence with the transfer device
- being inserted into the stoppered opening of a diluent bottle or vial;
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Figure 12' is a side sectional view showing the operation of the ~ ~
.. ..
~;~ device o Figures 1' - 3' in the transfer of fluid between medicament contain-
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, ers. :`
Turning to the drawings in greater detail, the fluid transfer de- .
' 10 vice of Figures 1-16 comprises parallel fluid passages 10 and 12 of flange
14. The 1uid passages are approximately equal in length with bias-cut ends
;'~ or openings 16 and 18J and 20 and 22, which are opposed to each other, I
' have found that if the ends of tlle fluid passage aro oppositely facing or
r'j~ displaced from one another, the downcoming diluent or liquid cannot form a
j block or slug in the air riser passage. If, however, the ends or openings
of the fluid passages face each other, an air block can develop which prevents
or stops the fluid transfer. Accordingly, the disposition of the ends of ~ ~
the fluid passages is a significant feature of this invention. Preferably, ;
the one end of the devlce lS covered with a cap 24, the inside of which has
an interference or press fit with the exterior surface 26 of the transfer ;;
~?:~ device to form a seal~The cap 24 has a flange portion 28 which abuts flange ~ ~;
^~ 14 when the cap is fully advanced over the fluid transfer device. ` `
gr~ The use of the device is clearly shown in Figures 9 - 12. The J~
transfer device is forced downwardly through the stopper ~usually rubber) 30
on the container 32 for the dry or lyophilized materlal until 1ange 14 abuts !i?
stopper 30, Then, as shown in Flgure 1OJ the cap 24 is removed wlth a twist- ;`
~`~ ing motion. The combination container 32 and fluid transfer device is then `
inverted as shown in Figure 11 over the dlluent contalner 34, which is also
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~;(, usually provided with a rubber stopper 36 in the neck 38 thereof, The points ``
20 and 22 are forced through stopper 36 until the containers are disposed as
shown in Figure 12. Fluid transfer then occurs automatically, with passage
~ 10 acting as a diluent or liquid downcomer and passage 12 acting as a path
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or riser for the displacement of air from container 32 upwardly into contain-
~ er 34, After transfer is comple~e, the empty diluent container 34 and the
- fluid transfer device are removed. The container 32 then contains the recon-
; stituted medicament in sterile form. The container 32 can be used in a var-
iety of ways, TypicallyJ its contents are administered using a conventional ^~
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intravenous solution set.
Figures 4JSJ and 13 - 15 show another embodiment of the cap of my
inv~ntion. In this embodiment, the cap 40 has a flange portion 42, The cap
; 40 seals on the transfer device as previously described, The cap 40 has a
projection 44 provided with an opening 46 at the end opposite flange 42,
'rhe projection is covered by an imperforate cap 48J which is normally resi~
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$~ lient, and held on projection 44 with a snap or inter~erence i~it, The conter
~,t of cap 48 is dished and has a central diaphragm S0 whicll ls adapted to bo
pierced with the needle 52 of a syringe or vial injector, In this way, as
~,i,,,, shown in Figure 15, a liquid medication can be withdrawn from or added to ,
'~ the diluent bottle or vial, It is to be understood that thereafter, the cap `
1; ,; 40 can be removed and transfer carried out with a second bottle as shown in
;¦ Figures 11 and 12.
The embodiment of Figures 7J8 and 16 has a cap 54 having a flange -;
20~ 56. The cap 54 seals on the transfer device as hereinbefore explained. The
cap 54 has a projection sa provided with an opening 60 at the end opposite
flange 56. The projection 58 is covered by imperforate cap 62 which is held
in projection 58 with a snap or interference fit. The center of cap 62 is
dished and has a central diaphragm 64 for piercing with a needle 66 of a
~¦ syringe or vial injector, The cap 54 also has an airway 68 provided with a , `
~i ilter 70 so that filtered air can enter cap 54 as medication is withdrawn
,, into the syringe. The flow of air isJ of courseJ reversed in the case of the
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I addition of medication from the syringe or vial injector to the diluent bottle 1
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;' or vial, ;
i 30 Turning to the drawings in greater detailJ the embodiment of Figures `,
1' - 31J 7' and '3' - 12' comprises parallel fluid passages 10' and 12' and
flange 14', The fluid passages are approximately equal in length but stagger-
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: ~37qL2~ : ~
ed so that the bias-cut ends or openings 16' and 18', and 20' and 22', are ~
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not immediately adjacent each other. Preferably, the one end of the device
~' is coverad with a protective cap. Cap 24' shown in Figure 7' inside forms -
an interference or press fit with the enlarged circular base portion 26' of
the transfer device to form a fluid-tight seal. The cap 24' has a flange
: portion 28' which abuts flange 14' when the cap is fully advanced over the
; ...................................................................... . .
i fluid transfer device.
In use, the device as shown in Figure 9', normally shipped in an ~;
imperforate tear-away, thin plastic bag, is forced downwardly through the
stopper (usually rubber) 30' on the container 32' for the dry or lyophilized l
material until flange 14' abuts stopper 30'. Then, as shown in Figure lO', ~'m~' '
the cap 24' is removed with a twisting motion. The combination container
32' and fluid transfer device is then inverted as shown in Pigure 11' over
the diluent container 34', which is also usually provided with a rubber
stopper 36' in the neck 38' thereo. The points 20' and 22' are forced ;
~;,j through stopper 36' until the containers are disposed as shown in Figure 12'. ;
Fluid transfer then occurs automatically, with passage 10' acting as a dil- ;
uent or liquid downcomer and passage 12' acting as a path for the displace-
ment of air from container 32' upwardly into container 34', After transfer -
is complete, the empty diluent container 34 and the fluid transfer device
are removed. The co~tainer 32' then contains the reconstituted medicament ~-
` ~ in sterile form. ~he container 32' can be used in a variety of ways. Typi-
cally, its contents are administered using a conventional intravenous solu-
tion set. ~lowever, this invention is not so limited and is applicable to
the transfer of liquids between any stoppered containers.
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l Alternatively, the fluid trans~er device mny have the configuration
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shown in Figures 4' - 6' and 8'. In said Figures, the passages 48' and 50'
, are formed by center divider 52'. The flange is identi~ied as 54'. In large `;
;l devices, the divider 52' is adequate to prevent the formation of n diluent
or liquid slug in the air viser passage. In smaller size transfer devices,
this is not true, in which case it is necessary to provide pressure relieving , i
openings 56'. The openings 56' prevent a fluid slug from forming and shutting ~
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; off the transfer of liquid and air. The transfer device of Figures 4' - 6' .~:
`. and 8' are used with diluent container and dry or lyophilized material con-
,~ tainer in the manner previously described.
~ I`he fluid transfer device of Figures 4' - 6' is generally smaller ..
`; in diameter than the device of Figures 1' - 3', and hence is adapted to be ~.
; used with small-llecked bottles and vials.
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