U.S. patent application number 10/062796 was filed with the patent office on 2007-11-22 for fluid transfser device.
Invention is credited to Igor Denenburg, Freddy Zinger.
Application Number | 20070270778 10/062796 |
Document ID | / |
Family ID | 46149079 |
Filed Date | 2007-11-22 |
United States Patent
Application |
20070270778 |
Kind Code |
A9 |
Zinger; Freddy ; et
al. |
November 22, 2007 |
FLUID TRANSFSER DEVICE
Abstract
A fluid ducting assembly for enabling flow communication between
a syringe and either one of a vessel and a dispenser for dispensing
a fluid contained, a priori in the syringe or in the vessel. The
fluid ducting assembly includes a base having a first member, a
second member, and a third member for connection to and providing
flow communication with the syringe, the vessel and the dispenser,
respectively. The fluid ducting assembly further includes a flow
controller within the base enabling any one of a flow path between
the first member and the second member and a flow path between the
first member and the third member. The flow controller has either a
first operative position in which the flow path between the first
member and the second member is enabled or a second operative
position in which the flow path between the first member and the
third member is enabled. The flow controller being readily
switchable from its first operative position to its second
operative position but not readily switchable from its second
operative position to its first operative position.
Inventors: |
Zinger; Freddy; (Ra'anana,
IL) ; Denenburg; Igor; (Rehovot, IL) |
Correspondence
Address: |
AKIN GUMP STRAUSS HAUER & FELD L.L.P.
ONE COMMERCE SQUARE
2005 MARKET STREET, SUITE 2200
PHILADELPHIA
PA
19103
US
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20020087144 A1 |
July 4, 2002 |
|
|
Family ID: |
46149079 |
Appl. No.: |
10/062796 |
Filed: |
January 31, 2002 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
09633056 |
Aug 8, 2000 |
6379340 |
|
|
10062796 |
Jan 31, 2002 |
|
|
|
08913432 |
Sep 17, 1997 |
6238372 |
|
|
PCT/US96/03732 |
Mar 19, 1996 |
|
|
|
09633056 |
Aug 8, 2000 |
|
|
|
08407287 |
Mar 20, 1995 |
|
|
|
08913432 |
Sep 17, 1997 |
|
|
|
08499213 |
Jul 7, 1995 |
|
|
|
08913432 |
Sep 17, 1997 |
|
|
|
Current U.S.
Class: |
604/523 ;
604/905 |
Current CPC
Class: |
A61J 1/2075 20150501;
A61M 39/223 20130101; A61M 2039/1077 20130101; A61M 39/18 20130101;
A61J 1/2062 20150501; A61J 1/2096 20130101; A61J 1/2058 20150501;
A61J 1/2082 20150501; A61J 1/2089 20130101; A61J 1/201 20150501;
A61M 5/162 20130101; A61J 1/2013 20150501 |
Class at
Publication: |
604/523 ;
604/905 |
International
Class: |
A61M 25/00 20060101
A61M025/00 |
Foreign Application Data
Date |
Code |
Application Number |
Aug 16, 1995 |
IL |
114960 |
Claims
1. A fluid control device for use with a vial having a container
portion; an upper, generally cylindrically shaped portion; and an
intermediate neck portion, for delivering the contents of the vial
to a patient, the fluid control device including an adapter for
interconnection with the vial, said adapter comprising: (a) a top
wall; and (b) a resiliently deformable skirt connected to said wall
and extending therefrom for telescopically receiving the upper
portion of the vial, said skirt having: (i) a generally cylindrical
body portion; (ii) an angularly outwardly extending marginal
portion; and (iii) an angularly inwardly extending intermediate
portion disposed between said body portion and said outwardly
extending intermediate portion for releasably gripping the
vial.
2. The device as defined in claim 1 in which said adapter further
includes a cannula connected to said top wall and extending into
said skirt.
3. The device as defined in claim 1 in which said skirt is provided
with a plurality of circumferentially spaced slits.
4. The device as defined in claim 1 in which said intermediate
portion comprises a circumferentially extending protuberance formed
intermediate said body portion and said angularly outwardly
extending marginal portion.
5. The device as defined in claim 1 in which said adapter further
includes a connector portion connected to said top wall and filter
means for filtering the fluid within the vial, said filter means
being carried by said connector portion.
6. The device as defined in claim 1 in which said adapter further
includes venting means for providing an air passageway between the
interior of the vial and atmosphere.
7. A fluid control device for use with a vial having a container
portion; an upper, generally cylindrically shaped portion; and an
intermediate neck portion, for delivering the contents of the vial
to a patient, the fluid control device including an adapter for
interconnection with the vial, said adapter comprising: (a) a top
wall; and (b) a resiliently deformable skirt connected to said wall
and extending therefrom for telescopically receiving the upper
portion of the vial, said skirt having: (i) a generally cylindrical
body portion; (ii) an angularly outwardly extending marginal
portion; and (iii) an angularly inwardly extending intermediate
portion disposed between said body portion and said outwardly
extending intermediate portion for releasably gripping the vial;
(c) a cannula connected to said top wall and extending into said
skirt; and (d) a connector portion connected to said top wall and
extending therefrom for connecting tubing to said adapter.
8. The device as defined in claim 7 in which said adapter portion
includes a tapered bore having a cavity formed therein and further
includes a filter disposed within said cavity.
9. The device as defined in claim 7 in which said cannula includes
first and second spaced apart lumens, said second lumen defining a
venting passageway for permitting the flow of air between the
interior of the vial and the exterior thereof.
10. The device as defined in claim 9 further including filter means
carried by said top wall for filtering air flowing toward the
exterior of the vial.
11. The device as defined in claim 9 in which said filter means
comprises a filter that permits the flow of liquid therethrough,
but prevents the flow of air therethrough.
12. The device as defined in claim 9 in which said skirt is
provided with a plurality of circumferentially spaced slits.
13. A fluid control device for use with a vial containing a
lypholized drug for mixing the lypholized drug with a diluent, the
vial having a generally cylindrically shaped top portion, a body
portion and an intermediate neck portion, said fluid control device
comprising an adapter receivable over the top portion of the vial,
said adapter comprising: (a) a top; (b) a resiliently deformable
skirt integrally formed with said top and extending therefrom, said
skirt including: (i) a body portion (ii) an outwardly extending
marginal portion; (iii) an inwardly extending intermediate portion
located between said body portion and said marginal portion for
releasably gripping the vial; and (c) a hollow cannula connected to
said top wall and extending into said skirt.
14. The device as defined in claim 13 in which said skirt portion
of said adapter is provided with at least two circumferentially
spaced slits.
15. The device as defined in claim 16 in which said adapter is
molded in a single piece from a moldable plastic.
16. The device as defined in claim 13 in which said adapter further
includes a connector portion connected to said top wall and
extending therefrom.
17. The device as defined in claim 16 in which said connector
portion includes a tapered bore having an upper portion having an
inwardly tapering wall and a lower portion having an outwardly
tapering wall.
18. The device as defined in claim 17 further including filter
means disposed within said lower portion of said tapered bore for
filtering fluid flowing through said tapered bore.
19. The device as defined in claim 16 in which said cannula
includes first and second spaced apart lumens, said second lumen
defining a venting passageway for permitting the flow of air
between the interior of the vial and the exterior thereof.
20. The device as defined in claim 19 further including filter
means carried by said top wall for filtering air flowing toward the
exerior of the vial.
Description
[0001] This is a Continuation-In-Part Application of co-pending
U.S. Ser. No. 09/633,056 filed Aug. 8, 2000 which is a Divisional
Application of U.S. Ser. No. 08/913,342 now U.S. Pat. No.
6,238,372B1.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] 2. Discussion of the Prior Art
[0004] Drugs intended for parenteral administration are typically
stored in a medicinal vessel either as a dry powder or as a
solution. The solution can be ready for immediate use or in the
form of a liquid concentrate which requires reconstitution with a
physiological solution prior to administration in a similar manner
to a dry powder drug. The physiological solution can be provided in
a pre-filled syringe or a medicinal vessel.
[0005] Medicinal vessels typically fall into one of three
categories. The first type is a vial or a glass bottle closed by a
rubber stopper which can be penetrated by a puncturing tool, for
example, a needle, and which is self-closing upon withdrawal of the
puncturing tool. Such a vial or glass bottle can contain a single
dose or a multiple dose of a drug. The drug contained in a vial can
be under a high vacuum. The second type is an ampoule whose top
portion is broken off enabling access to its contents. The third
type is an IV bag provided with a sample port for enabling access
to its contents. The sample port can be of the pre-slit septum
type.
[0006] Regardless of the manner in which a drug is stored, there is
a need to transfer fluid under sterile conditions before its
administration to a patient by a dispensing tool be it a needle, a
pre-slit septum, or the like. When a prior dilution of a drug is
required, the process requires at least two fluid transfers. The
problem of ensuring proper fluid transfer under aseptic conditions
is especially acute in the case of Self-administration of drugs by
patients in their homes.
[0007] Assemblies which have hitherto been proposed for the aseptic
administration of drugs are described in U.S. Pat. No. Des.
271,421, U.S. Pat. Nos. 3,618,637, 3,757,981, 3,826,261, 3,957,052,
3,977,555, 3,993,063, 4,051,852, 4,564,054, 4,604,093, 4,721,133,
4,758,235, 4,967,797, 4,997,430, 5,201,705, 5,269,768, 5,279,576,
5,288,290, 5,334,163, and 5,466,220, and European Publication Nos.
0 258 913 A2, 0 195 018 B1, 0 192 661 B1, and 0 416 454 B1.
[0008] In particular, EP 0 521 460 B1 describes a fluid control
device for use with a syringe and a pair of medicinal vessels. The
fluid control device includes a housing with a luer-connector port
for receiving the syringe and second and third ports each
comprising an adaptor having a fluid conduit member extending into
the interior of a medicinal vessel when attached thereto. In the
housing, a flow control member is slidingly displaceable from a
first flow control position enabling a flow path between the two
medicinal vessels when connected and a second flow control position
enabling a flow path between one of the medicinal vessels and the
syringe.
SUMMARY OF THE INVENTION
[0009] The object of the invention is to provide fluid control
devices enabling the aseptic administration of drugs.
[0010] In accordance with the invention, there is provided a fluid
control device for use with a syringe and at least one medicinal
vessel, the fluid control device comprising: [0011] (a) a first
port; [0012] (b) a second port for receiving the syringe; [0013]
(c) a third port comprising an adaptor having a fluid conduit
member extending into the interior of the medicinal vessel when
attached thereto; and [0014] (d) a flow control member selectively
disposable from a first flow control position enabling a flow path
between a first pair of two ports and a second flow control
position enabling a flow path between a second pair of two ports,
said flow control member being coupled to one of said ports for
manipulation between said flow control positions.
[0015] In accordance with the teachings of the present invention,
there is provided a family of fluid control devices which are
adapted for the aseptic administration of drugs either directly or
indirectly to a patient. The selection of the most suitable fluid
control device depends on the type of drug to be administered to a
patient, the manner in which it is packaged, the manner in which it
is to be administered to a patient and by whom apart from other
factors. Some of the devices are designed to enable the
reconstitution of a drug provided in a powder form or as a liquid
concentrate. Some of the devices are suited for vials or ampoules
containing a single dose of a drug whilst others are suited for
vials or IV bags containing multiple doses.
[0016] In a preferred embodiment of a fluid control device, the
flow control member is rotatably mounted in a body member so as to
be selectively rotatable between its first flow control position
and its second flow control position.
[0017] In a preferred embodiment of a fluid control device, the
first port is adapted for dispensing a drug directly or indirectly
to a patient and, as such it can be provided with a needle, it can
be fashioned as a male luer connector on which a needle can be
mounted or it can be fashioned as a plastic cannula for insertion
into a pre-slit septum. In such an embodiment, the adaptor is
preferably coupled to a flow control member adapted for rotation in
a body member having the port adapted for receiving a syringe and
the dispensing port.
[0018] The adaptor can be integrally formed with the flow control
member and designed so as to readily broken off therefrom after
rotation of the flow control member from its first flow control
position to its second flow control position. Alternatively, the
adaptor can be detachably engaged to the flow control member by
means of an interengaging means enabling axial detachment of the
adaptor from the body member on a relative rotation therebetween to
a position which urges the flow control member from its first flow
control position to its second flow control position.
[0019] In a preferred embodiment of a fluid control device suitable
for use with drugs which require reconstitution, the fluid control
device includes a fourth port in the form of an adaptor for
enabling the he attachment of a second medicinal vessel to the body
member.
[0020] In a preferred embodiment of a fluid control device, the
first port is also provided with an adaptor adapted for attachment
thereto of a medicinal vessel and, in this case, the port adapted
for receiving the syringe is rotatably coupled to the flow control
member.
[0021] In each case, the adaptor can be adapted for attachment
thereto of a vial, an ampoule or an IV bag, the former requiring
that the fluid conduit member be formed as a puncturing tool for
piercing the vial's rubber stopper on its attachment thereto. In
the case of attachment of an ampoule, because the ampoule cannot be
inverted, the fluid conduit member is required to be provided as a
long straw to enable all or nearly all of its contents to be
aspirated therefrom.
[0022] The adaptor can also include a conduit for venting the
vessel when attached thereto. The conduit can include a filter for
filtering the air traversing therethrough. The filter can be
deployed within a lateral cavity provided within the adaptor or,
alternately, the filter can be provided as a discrete element
exterior to the fluid control device.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] For a better understanding of the present invention and to
show how the same may be carried out in practice, and solely by way
of non-limiting examples, reference will now be made to the
accompanying
drawings, in which:
[0024] FIG. 1 is a perspective view of an assembled fluid control
device including a base member and an integrally formed adaptor cum
flow control member for use with a syringe and a medicinal
vessel.
[0025] FIG. 2 is a perspective view of the fluid control device of
FIG. 1 before assembly.
[0026] FIG. 3 is a vertical cross sectional view of the fluid
control device of FIG. 1 along the line A-A after insertion of a
syringe and the attachment of a vial and before rotation of the
adaptor relative to the base member.
[0027] FIG. 4 is a horizontal cross sectional view of the fluid
control device of FIG. 1 along the line B-B after insertion of a
syringe and the attachment of a vial and before rotation of the
adaptor relative to the base member.
[0028] FIG. 5 is a horizontal cross sectional view of the fluid
control device of FIG. 1 along the line C-C before rotation of the
adaptor relative to the base member.
[0029] FIG. 6 is a vertical cross sectional view of the fluid
control device of FIG. 1 along the line A-A after rotation of the
adaptor relative to the base member.
[0030] FIG. 7 is a horizontal cross sectional view of the fluid
control device of FIG. I along the line B-B after rotation of the
adaptor relative to the base member.
[0031] FIG. 8 is a horizontal cross sectional view of the fluid
control' device of FIG. 1 along the line C-C before rotation of the
adaptor relative to the base member.
[0032] FIG. 9 is a perspective view of a modified integrally formed
adaptor cum now control member adapted such that. the adaptor
breaks off from the flow control member on rotation of the adaptor
relative to the base member beyond a pre-determined position.
[0033] FIG. 10 is a perspective view of a fluid control device
including the modified adaptor cum flow control member of FIG. 9
after the adaptor has been broken off.
[0034] FIG. 11 is a perspective view of an assembled fluid control
device including a base member and an adaptor designed for
releasable engagement with the base member.
[0035] FIG. 12 is a perspective view of the fluid control device of
FIG. 11 after the adaptor has been rotated through a quarter turn
ready for its detachment from the base member;
[0036] FIG. 13 is a vertical cross sectional view of the base
member of the fluid control device of FIG. 11.
[0037] FIG. 14 is a vertical cross sectional view of the. adaptor
of the fluid control device of FIG. 11.
[0038] FIG. 15 is a perspective view of the flow control member of
the fluid control device of FIG. 11.
[0039] FIGS. 16A and 16B are vertical cross sectional views of a
fluid control device in which the flow control member is required
to be rotated through 180.degree. to enable switching between its
flow control position.
[0040] FIG. 17 is a vertical cross sectional view of a fluid
control device provided with an arrangement for the venting of a
vial attached to its adaptor.
[0041] FIGS. 18A and 18B are two views depicting a fluid control
device having a filter for filtering air venting a vial attached to
its adaptor, the filter being provided as a discrete element
exterior to the device.
[0042] FIG. 19 is a vertical cross sectional view of a fluid
control device having an adaptor provided with a lateral cavity for
receiving a filter for filtering air venting a vial attached
thereto.
[0043] FIG. 20 is a vertical cross sectional view of a fluid
control device in a first operative position enabling flow
communication between a medicinal vessel containing a powder drug
and a medicinal vessel containing a physiological solution for
enabling reconstitution of the powder drug.
[0044] FIG. 21 is a vertical cross sectional view of the fluid
control device of FIG. 20 in a second operative position enabling
flow communication between the vial containing the reconstituted
drug and a syringe.
[0045] FIG. 22 is a vertical cross sectional view of the fluid
control device of FIG. 20 in a third operative position enabling
flow communication between the syringe and a dispensing port.
[0046] FIG. 23 is a longitudinal cross sectional view of a fluid
control device for use with a syringe and a pair of medicinal
vessels.
[0047] FIG. 24 is a horizontal cross section sectional view, of the
flow control member of the fluid control device of FIG. 23 along
line D-D.
[0048] FIG. 25 shows a series of steps (FIGS. 25A-25F) depicting
the operation of the fluid control device of FIG. 23.
[0049] FIG. 26 is a longitudinal cross sectional view of the fluid
control device of FIG. 23 with a modified flow control member.
[0050] FIG. 27 is a horizontal cross sectional view of the flow
control member of FIG. 26 along line E-E in FIG. 26.
[0051] FIG. 28 is a longitudinal cross sectional view of a modified
fluid control device of FIG. 23 with an in-line filter.
[0052] FIG. 29 is a longitudinal cross sectional view of a fluid
control device with a modified adaptor enabling venting of a
medicinal vessel attached thereto fitted with a hydrophobic
filter.
[0053] FIG. 30 is a side-elevational view, partly in cross section
of an alternate form of adapter component of the present
invention.
[0054] FIG. 31 is a greatly enlarged, cross-sectional view of the
area designated 31-31 in FIG. 30.
[0055] FIG. 32 is a side-elevational view partly in cross section
similar to FIG. 30 but showing the filter element disposed within a
specially configured cavity formed at the base of the upper
connector portion of the adapter that extends from the top wall
thereof.
[0056] FIG. 33 is a greatly enlarged, cross-sectional view of the
area designated as 33-33 of FIG. 32 better illustrating the
configuration of the filter and the filter retaining cavity.
[0057] FIG. 34 is a cross-sectional view similar to FIG. 33, but
showing the filter element in the process of being inserted into
the connector portion.
[0058] FIG. 35 is a cross-sectional view similar to FIG. 34, but
showing the filter element seated within the filter receiving
cavity.
[0059] FIG. 36 is a side-elevational, cross-sectional view of still
another form of the adapter component of the present invention.
[0060] FIG. 37 is a greatly enlarged cross-sectional view of the
area designated as 37-37 in FIG. 36.
DESCRIPTION OF THE INVENTION
[0061] FIGS. 1-8 depict a first embodiment of a fluid control
device, generally designated 10, constructed and operative in
accordance with the teachings of the present invention for enabling
fluid flow control between a syringe, a medicinal vessel and a
dispensing port. The fluid control device 10 includes an elongated
base member 11 having a port 12 adapted for receiving a syringe and
a dispensing port 13 fashioned as a plastic cannula for insertion
into a pre-slit septum assembly known in the art per se. The port
12 is typically fashioned as a female luer connector.
[0062] As shown in FIG. 3, the port 12 includes a lumen 14 having
an interior opening 14' and the dispensing port 13 includes a lumen
16 having an interior opening 16'. The lumens 14 and 16 are
co-axial and in flow communication via a bore 17 transversely
disposed relative to the elongated base member 11. The bore 17
includes an upper peripheral flange 18 and a lower minor peripheral
abutment wall portion 19 protruding radially inward relative to its
major peripheral wall portion 19' (see FIG. 5), As shown, the
abutment wall portion 19' typically extends through an arc angle of
about 90.degree..
[0063] The fluid control device 10 further includes an integrally
formed adaptor and flow control member, generally designated 20,
for insertion into the bore 17 in which it is restrained therein by
means of a peripherally formed groove 22 designed for receiving the
flange 18 therein. The flow control member 20' is formed with two
flow ducts as follows: A first flow duct 23 (see FIG. 3) in the
form of an L-shaped channel having a radial aperture 23' for
registration with the interior opening 14' and an axial aperture
23' of a fluid conduit member 24 integrally formed as part of the
adaptor 20'' on disposition of the flow control member 20' in a
first flow control position enabling flow communication between a
syringe inserted in the port 12 and a vessel attached to the
adaptor 20''. A second flow duct 25 (see FIG. 4) in the form of a
peripheral slightly longer than a semi-circular groove 25 having a
first end portion 25' for registration with one of the interior
openings 14' and 16' and a second end portion 25'' for registration
with the other of the interior openings 14' and 16' on disposition
of the flow control member 20' in a second flow control position
enabling flow communication between a syringe inserted in the port
12 and the dispensing port 13.
[0064] In addition, the flow control member 20' is provided with a
minor peripheral abutment wall portion 26' protruding radially
outward relative to its major peripheral wall portion 26'' (see
FIG. 5). As shown, the abutment wall portion 26' typically extends
through an arc angle of about 90.degree.. The minor peripheral
abutment wall portions 19' and 26' are so disposed such that they
assume substantially diagonally opposing positions relative to one
another (see FIG. 5) in the first flow control position of the flow
control member 20'.
[0065] The adaptor 20'' is shown to be adapted for the attachment
thereto of a vial 28 (not drawn to size) provided with a rubber
stopper 29. As such, the fluid conduit member 24 is fashioned as a
puncturing tool 30 for penetrating a rubber stopper 29 on
attachment of a vial 28 to its adaptor 20''. Alternatively, the
adaptor 20'' can be adapted for the attachment thereto of an
ampoule 31 (not drawn to size), the difference. being that such an
adaptor will preferably have relatively long springy grips.
[0066] Each stage of the two stage operation of the fluid control
device 10 for the administration of a drug provided in powder form
for dilution with a physiological solution provided in a pre-filled
syringe is now described with reference to FIGS. 3-5 and FIGS. 6-8,
respectively.
[0067] As shown in FIGS. 3-5, the fluid control device 10 is best
provided in a set-up position in which the flow control member 20'
is in its first flow control position and the two minor abutment
wall portions 19' and 26' are diagonally opposed to one another. As
shown, it should be noted as best seen in FIG. 4, that the
semi-circular groove 25 registers with the interior opening 16' but
does not provide a flow path.
[0068] In this arrangement, a pre-filled syringe 32 is inserted
into the port 12 and the vial 28 is attached to the adaptor 20'' by
means of which action, the puncturing tool 30 punctures the vial's
rubber stopper 29, thereby enabling flow communication with its
interior via the fluid conduit member 24. Typically, the syringe 32
requires actuation for expressing its contents into the vial 28
while in some cases, if the contents of the vial 28 are under
vacuum, then the physiological solution of the syringe 32 can be
sucked into the vial without user intervention. Thereafter, the
contents of the vial 28 are shaken so as to reconstitute the
powdered drug. The fluid control device 10 together with the vial
28 are then preferably inverted and the syringe 32 is aspirated so
as to draw the reconstituted liquid drug thereinto.
[0069] Turning now to FIGS. 6-8, the vial 28 together with the
adaptor 20'' are rotated in either a clockwise or a counter
clockwise control position enabling a flow path between the port 12
and the dispensing port 13. Preferably, there is a screw thread
engagement between the base member 11 and the adaptor 41 designed
such that there is an axial displacement of the adaptor 41 away
from the base member 11 when it is rotated from its engaging
position to its disengaging position.
[0070] It can be readily appreciated that the advantage. of this
design over the design of the fluid control device 34 while
retaining all the advantages of the latter resides in the fact that
the former is reusable after sterilization while the latter can
only be used once due to the destruction of the adaptor cum flow
control member 35.
[0071] A further difference between the fluid control devices 40
and 10 resides in the fact the former includes a dispensing port 13
provided with a needle 47.
[0072] FIGS. 16A and 16B depict a fourth embodiment of a fluid
control device, generally designated 48, constructed and operative
in accordance with the teachings of the present invention for
enabling fluid flow control between a syringe, a medicinal vessel
and a dispensing port. The fluid control device 48 is similar in
construction and operation to the fluid control device 41 and
therefore the same reference numerals are used where
appropriate.
[0073] The main difference between the two fluid control devices 48
and 41 resides in the fact that the former includes a flow control
member 49 which is required to be rotated through a 180.degree.
turn between its first flow control position (see FIG. 16A) and its
second flow control position (see FIG. 16B). In particular, the
flow control member 49 includes an inclined channel 50 having a
radial aperture 50' for registration with the interior opening 14'
and an axial aperture 50'' for registration with the fluid conduit
member 24 so as to enable the flow path between a syringe and the
interior of a medicinal vessel. And, the flow control member 49
includes a second inclined channel 52 having a radial aperture 52'
for registration with the interior opening 14' and a radial
aperture 52'' for registration with the interior opening 16' so as
to enable the flow path between a syringe to the dispensing port
13. As shown, in this case, the lumens 14 and 16 are not
co-axial.
[0074] FIGS. 17-19 depict other modified fluid control devices,
generally-designated 53, 54 and 55, constructed and operative in
accordance with the teachings of the present invention for enabling
fluid flow control between a syringe, a medicinal vessel and a
dispensing port The fluid control device 53, 54 and 55 are similar
in construction and operation to the fluid control device 41 and
therefore the same reference numerals are used where appropriate.
The main difference between the fluid control devices 53, 54 and 55
and the fluid control device 41 is that they provide arrangements
for venting a vial and, if necessary, for filtering incoming
air.
[0075] Turning now to FIG. 17, the fluid control device 53 includes
an adaptor 56 provided with a venting conduit 58 for venting a vial
28 to the atmosphere in addition to the fluid conduit member 24.
The venting conduit 58 is preferably provided with a filter 59 for
filtering incoming air. Turning now to FIGS. 18a and 18b, the fluid
control device 54 is similar to the fluid control device 53 except
that it includes a filter 60 exterior to the adaptor 56. Turning
now to FIG. 19, the fluid control device 55 is similar to the fluid
control device 53 except that its adaptor 61 includes an integrally
formed disposed filter 62.
[0076] FIGS. 20-22 depict a fluid control device, generally
designated 64, for enabling the reconstitution of a powder drug
with a physiological solution contained in a medicinal vessel
instead of within a pre-filled syringe as required with the fluid
control device 10. The fluid control device 64 is similar in
construction and operation to the fluid control device 41 and
therefore the same reference numerals are used where
appropriate.
[0077] The main difference between the two fluid control devices 64
and 41 resides in the fact that the former is adapted to be fitted
with two medicinal vessels and, as such, its base member 11 is
provided with a port 12, a dispensing port 13 and two bores 17A and
17B which are interconnected by a channel 65. As shown, the
medicinal vessels are vials 28A and 29B where the vial 28A contains
the powdered drug and the vial 28B contains the physiological
solution for diluting the powdered drug. As explained in greater
detail hereinbelow for the case when the vial 28A has its contents
under high vacuum, the sequence and order of the attachment of the
vials 28A and 28B to the adapters 41A and 41B is not arbitrary.
[0078] In this case, the flow control member 42A has a first flow
control position in which its L-shaped flow duct 23A registers in
flow communication with the channel 65 and a medicinal vessel
attached to its adaptor 41A (see FIGS. 20 and 21) and a second flow
control position in which its peripheral groove flow duct 25A
registers in flow communication with the channel 65 and the
dispensing port 13 (see FIG. 22). In contrast, the flow control
member 42B has a first flow control position in which its L-shaped
flow duct 23B registers in flow communication with the channel 65
and a medicinal vessel attached to its adaptor 41B (see FIG. 20)
and a second flow control position in which its peripheral groove
flow duct 25B registers in flow communication with the channel 65
and. the port 12 (see FIGS. 21 and 22).
[0079] The operation of the fluid control device 64 for the
administration of a powder drug provided in the pressurized vial
28A after reconstitution with a physiological solution provided in
the vial 28B is now described. First, as shown in FIG. 20, the
fluid control device 64 is provided in its first operative
position, namely, enabling the flow path between the vials 28A and
28B when they are attached to the base member 11. It should be
noted that the vial 28B is attached to the adaptor 41B and
thereafter the pressurized vial 28A is attached to the adaptor 41A
such that. the physiological solution contents of the vial 41B is
sucked into the vial 28A. Reconstitution typically requires shaking
the fluid control device 64. As shown in FIG. 21, the adaptor 41B
together with the vial 28B are then rotated so as to enable their
detachment from the base member I1 while at the same time,
effecting the rotation of the flow control member 42B so as to
enable a flow path between the port 12 and the remaining vial 28A.
A syringe 66 is inserted into the port 12 and, after inversion of
the fluid control device 64 such that the vial 28 containing the
reconstituted drug assumes an upward position, the syringe 66 is
aspirated to draw the contents of the vial 28A thereinto.
Thereafter, as shown in FIG. 22, the adaptor 41A together with the
vial 28A are rotated so as to enable their detachment from the base
member 11 while, at the same time, effecting the rotation of the
flow control member 42A so as to enable a flow path between the
syringe 66 and the dispensing port 13. Finally, in this position,
the syringe 66 is actuated so as to express the drug for its
administration to a patient via the dispensing port 13. Finally in
this position, the syringe 66 is actuated so as to express the drug
for its administration to a patient via the dispensing port 13.
[0080] FIGS. 23-25 depicts a fluid control device 67 allowing the
preparation of a drug by the mixing between a first substance
contained in a first medicinal vessel and a second substance
contained in a second medicinal vessel and thereafter the transfer
of the drug to a dispensing tool, namely, a syringe. The fluid
control device 67 includes a base member 68 having a generally
tubular intermediate portion 70 defining a lumen 71 in which a flow
control member 72 is rotatably inserted. The flow control member 72
has a port 73 for receiving a dispensing tool typically, a syringe
74 (see FIG. 25). The port 73 is preferably fashioned as a female
luer connector. The flow control member 72 also has integrally
formed handles 76 for enabling a manual rotating thereof. As shown,
a filter 77 can also be deployed within the port 73 for filtering a
drug on its aspiration into a syringe 74.
[0081] The base member 68 includes two adapters 78 and 79 which are
adapted for the attachment thereto of medicinal vessels. In this
case, the adapters 78 and 79 are adapted for the attachment thereto
of vials and, as such, they include respective co-axial fluid
conduit members 78' and 79' fashioned as piercing tools for
puncturing the vials' rubber stoppers. The fluid conduit members
78' and 79' have respective internal apertures 78'' and 79''.
[0082] The flow control member 72 is rotatably mounted for enabling
either, in a first flow control position, a flow path between vials
attached to the adapters 78 and 79 or, in a second flow control
position, a flow path between a syringe and one of the vials. As
such, in a similar manner to the flow control member 20' (see FIGS.
3 and 4), flow control .member 72. includes two flow ducts as
follows: A first flow. duct 80 in the form of a peripheral groove
slightly longer than semi-circular having end portions 80' and 80''
for registration with the interior apertures 78'' and 79'' so as to
enable a flow path between the interiors of vials when attached to
the adapters 78 and 79. And a second flow duct 82 in the form of an
L-shaped channel having a radial aperture 82' for registration with
the interior opening 71' and an axial outlet port 82'' so as to
enable a flow path between a vial attached to one of the adapters
78 and 79 and a syringe inserted in the port 77.
[0083] The operation of the fluid control device 67 is now
described with reference to the steps depicted in FIG. 25 for the
case that a vial 83 contains a dried drug, e.g. a powder, a
crystalline material, a lyophilizate, etc., stored under a high
vacuum and a vial 84 contains a physiological solution. As
explained in greater detail hereinbelow for the case when the vial
83 has its contents under a high vacuum, the sequence of attachment
of the vials 83 and 84 to the adapters 78 and 79 is not
arbitrary.
[0084] The fluid control device 67 is typically provided in a
hermetically sealed package with its flow control member 72 set so
as to enable the flow path between flow conduit members 78' and 79'
by means of the ends 80' and 80'' of its semi-circular groove 80
registering with their interior openings 78'' and 79'' (FIG. 25A).
The vial 84 containing the diluent solution is attached to the
adaptor 78 (FIG. 25B), the action of attachment puncturing its
rubber stopper and thereafter the vial 83 containing the dried drug
is attached to the adaptor 79 (FIG. 25C) thereby sucking the
diluent solution thereinto once its rubber stopper is punctured
(FIG. 25D). The contents of the vial 83 are then shaken so as to
mix the diluent solution with the dried drug.
[0085] The syringe 74 is inserted into the port 73 (FIG. 25D) and
the flow control member 72 is rotated through a quarter turn
relative to the base member 11 such that the flow path between the
syringe 74 and the vial 83 is enabled. (FIG. 25E). The fluid
control device 67 is then inverted (FIG. 25F) and the syringe 74 is
aspirated so as to draw the reconstituted drug thereinto, the
medicinal preparation passing through a deployed filter 77, if any,
thereby becoming particle free for administration to a patient.
[0086] FIGS. 26 and 27 depict the fluid control device 67 with a
modified flow control member 85 having just the L-shaped flow duct
82, thereby requiring that it be rotated through a 180.degree. turn
for switching between its two flow control positions, the first
flow control position being between a syringe inserted in the port
73 and a first medicinal vessel while the second flow control
position being between a syringe inserted in the port 73 and a
second medicinal vessel.
[0087] The difference between the flow control member 85 and 72
being that a fluid control device 67 fitted with the former can be
employed with medicinal vessels in which their contents are under a
low vacuum or no vacuum, thereby requiring user intervention to
perform the mixing of the powder drug with the physiological
solution. In particular, the flow control member 85 is suitable for
use with a fluid control device 67 having an adaptor suitable for
connection to an IV bag such that on setting the flow control
member 85 in its first operative position, the syringe 74 is
aspirated so as to introduce a predetermined volume of diluent
solution thereinto. Thereafter, on setting the flow control member
85 into its second operative position, the syringe 74 is actuated
so as to introduce the diluent solution into a second medicinal
vessel containing the drug to be reconstituted. After mixing of the
drug with the diluent solution, the syringe 74 is aspirated a
second time so as to introduce the medicinal liquid thereinto at
which time the syringe 74 is removed for administration of the drug
to a patient. In this fashion, such a fluid control device can be
used a number of times with one or more medicinal vessels.
[0088] FIG. 28 depicts a fluid control device 86 with a port 87
provided with an integral in-line filter 88, thereby obviating the
need for a filter 77. FIG. 29 depicts a fluid control device 89
with a modified adaptor 90 having a vent conduit 91 for venting the
vial attached thereto provided with a hydrophobic filter 92 so as
to prevent wastage of the mixed drug when the fluid control device
89 is manipulated into the position shown in FIG. 25F.
[0089] Referring next to FIGS. 30 through 35, another form of the
adapter component of the invention is there shown. This novel
adapter component, which is generally designated in FIG. 30 by the
number 100, comprises a top wall 102, a hollow cannula 104 that is
connected to top wall 102 and depends therefrom and a resiliently
deformable skirt 106 that is connected to top wall 102. As
indicated in FIG. 30, a portion of skirt 106 extends downwardly
from top wall 102 and is adapted to telescopically receive the
generally cylindrically shaped upper portion of a bottle such as
bottle 28 (FIG. 1).
[0090] The skirt 106 of the adapter component is of a unique
configuration and includes a generally cylindrical body portion
106a, an angularly outwardly extending marginal portion 106b and an
angularly inwardly extending intermediate portion 106c that is
disposed between body portion 106a and marginal portion 106b. This
important intermediate portion 106c comprises a circumferentially
extending protuberance 106d that functions to releasably grip the
neck portion of bottle 28. As in the earlier described adapter
constructions, the adapter of the present form of the invention is
provided with a plurality of circumferentially spaced slits 110
that permit the skirt portion to flex sufficiently to enable it to
be expediciously snapped over the neck portion of the bottle.
[0091] Adapter 100 also includes a connector portion 112 that is
connected to top wall 102 and extends outwardly therefrom in the
manner shown in FIGS. 30 and 32. Connector portion 112 functions to
enable a length of tubing to be connected proximte one end thereof
to the adapter. Connector portion 112 also functions to house
filter means for filtering the liquid as it is removed from bottle
28. This important filter means here comprises an in-line,
disc-type filter 114 that is uniquely held in position within a
reverse taper socket 116 that is formed within connector portion
112 (see also FIGS. 32 and 33).
[0092] Referring particularly to FIG. 31, it is to be noted that
connector 112 is provided with a tapered bore 117, the upper wall
portion 117a of which tapers inwardly at an angle X relative to
vertical V. However, the lower wall portion 117b of the bore tapers
outwardly relative to vertical V at an angle of Y, so as to define
a reverse taper that forms the boundry of socket 116 within which
filter 114 is secured in the manner shown in FIGS. 32 and 33. With
this novel construction, the filter will be held securely in place
within the cavity in the manner best seen in FIG. 33.
[0093] Referring to FIGS. 36 and 37, still another form of the
adapter component of the present invention is there shown. This
adapter component is similar in some respects to adapter component
100. However, it is to be noted that the cannula 120 that depends
from top wall 122 of the adapter components has a first lumen 120a
that defines a fluid flow path between the interior of the bottle
and the flow passageway 124a of a connector 124 that extends
upwardly from top wall 122. Cannula 120 also has a second lumen
120b that defines a venting passageway for permitting the passage
of air between the interior of the drug bottle or vial and the
exterior thereof via appropriate air filtering means. This air
filtering means here comprises a conventional microporous filter
126 which permits venting of gases through the filter but prevents
the passage therethrough of liquid and particles of selected
sizes.
[0094] As in the earlier described embodiments, this later form of
adapter component is constructed of plastic and includes a skirt
128 that extends from top wall 122. Skirt 128 has a generally
cylindrically shaped portion 128a and an outwardly extending
marginal portion 128b. Skirt 128 also has an intermediate portion
128c that includes a circumferentially extending protuberance 128d
that functions in the manner previously described to releasably
grip the neck portion of the vial or drug bottle.
[0095] As indicated in the drawings, filter 126 is mounted within a
chamber 130 formed in top wall 122 of the adapter. With this
construction, during the vial filling step, displaced air can flow
from the interior of the bottle through lumen 120b in the direction
of the arrow 132 toward a disk filter 134, around lumen 120a,
through a passageway 136 in the direction of arrow 138 (FIG. 37).
The membrane portion 134a of disc filter 134 permits the flow of
air therethrough, while the blocking ring portion 134b prevents the
flow of air therethrough. After reaching the ring portion of the
disc filter, the air flows in the direction of arrows 138, 140, and
142 to atmosphere via air filter 126. During the infusion step,
when the medicinal fluid is being removed from the bottle and
administered to the patient via passageways 120a and 124a,
replacement air can flow through these same passageways from
atmosphere to the interior of the vial with the replacement air
being appropriately filtered by the filters carried by the adapter
component.
[0096] Having now described the invention in detail in accordance
with the requirements of the patent statutes, those skilled in this
art will have no difficulty in making changes and modifications in
the individual parts or their relative assembly in order to meet
specific requirements or conditions. Such changes and modifications
may be made without departing from the scope and spirit of the
invention, as set forth in the following claims.
* * * * *