U.S. patent application number 09/732857 was filed with the patent office on 2001-11-08 for fluid delivery apparatus with flow indicator and vial fill.
Invention is credited to Arnold, Steven M., Garrison, James, Kazemzadeh, Farhad, Kriesel, Marshall S..
Application Number | 20010039396 09/732857 |
Document ID | / |
Family ID | 25083143 |
Filed Date | 2001-11-08 |
United States Patent
Application |
20010039396 |
Kind Code |
A1 |
Kriesel, Marshall S. ; et
al. |
November 8, 2001 |
Fluid delivery apparatus with flow indicator and vial fill
Abstract
An apparatus for accurately infusing medicinal agents into an
ambulatory patient at specific rates over extended periods of time.
The apparatus is of a compact, low profile, laminate construction
and includes an elastic distendable membrane, chamber having a
fluid outlet. Disposed within the fluid chamber is a thin fluid
permeable member which precisely controls the rate of fluid flow
through the fluid outlet. The apparatus also includes a highly
novel fluid flow indicator that provides a readily discernible
visible indication of fluid flow through the apparatus.
Additionally, the apparatus includes a fill assembly comprising a
prefilled vial that can be used to fill the fluid reservoir of the
device with a selected medicinal fluid.
Inventors: |
Kriesel, Marshall S.; (Saint
Paul, MN) ; Arnold, Steven M.; (Minnetonka, MN)
; Garrison, James; (Minneapolis, MN) ; Kazemzadeh,
Farhad; (Bloomington, MN) |
Correspondence
Address: |
JAMES E. BRUNTON
P.O. BOX 29000
Glendale
CA
91209-9000
US
|
Family ID: |
25083143 |
Appl. No.: |
09/732857 |
Filed: |
December 7, 2000 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09732857 |
Dec 7, 2000 |
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09139605 |
Aug 24, 1998 |
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6159180 |
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09139605 |
Aug 24, 1998 |
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08768663 |
Dec 18, 1996 |
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5840071 |
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Current U.S.
Class: |
604/132 |
Current CPC
Class: |
A61M 5/16877 20130101;
A61M 5/152 20130101; Y10S 128/12 20130101; A61M 2205/585 20130101;
A61M 5/141 20130101; A61M 2205/583 20130101 |
Class at
Publication: |
604/132 |
International
Class: |
A61M 037/00 |
Claims
We claim:
1. A device for use in infusing medical fluids comprising: (a) a
base assembly including: (i) an ullage substrate having a receiving
chamber formed therein; and (ii) a hollow cannula mounted within
said receiving chamber; (b) stored energy means for forming in
conjunction with said base assembly a fluid reservoir having an
inlet in communication with said hollow cannula and an outlet, said
energy storage means comprising at least one distendable member
superimposed over said base, said member being distendable as a
result of pressure imparted by the fluids to be infused, to
establish internal stresses, said stresses tending to move said
member toward a less distended configuration; (c) fill means for
filling said fluid reservoir, said fill means comprising a fill
assembly including a container subassembly and an adapter
subassembly, said container subassembly comprising: (i) a fill
assembly including a fluid container and an adapter subassembly,
for interconnecting said fluid container with said base assembly;
and (ii) an auxiliary filling means including a housing connected
to said ullage substrate, said housing having a fluid inlet in
communication with said fluid reservoir, a fluid outlet spaced
apart from said fluid inlet and valve means for controlling fluid
flow between said fluid inlet and said fluid outlet; (d) an outlet
port in communication with said outlet of said reservoir for
dispensing fluids from the device; and (e) fluid actuated indicator
means disposed intermediate said fluid outlet of said reservoir and
said outlet port for visually indicating fluid flow from said fluid
reservoir.
2. A device as defined in claim 1 in which said fluid container of
said fill assembly has first and second open ends and in which said
fill assembly further includes: (a) pierceable means for sealably
closing one of said first and second open ends of said container,
said pierceable means being pierceable by said hollow cannula; and
(b) a plunger telescopically movable within said container from a
first location proximate said pierceable means to a second,
spaced-apart location.
3. A device as defined in claim 1 in which said indicator means
comprises first and second at least partially overlaying thin
films, said film being movable relative to each other in response
to fluid flowing from said fluid reservoir.
4. A device as defined in claim 1 further including flow control
means disposed intermediate said indicator means and said outlet of
said fluid reservoir for controlling the rate of flow of fluid from
the device.
5. A device for use in infusing medicinal fluid into a patient at a
controlled rate comprising: (a) a base having a receiving chamber
formed therein; (b) a hollow blunt end cannula mounted within said
receiving chamber of said base; (c) stored energy means for
forming, in conjunction with said base a fluid reservoir having an
inlet in communication with said hollow cannula and an outlet, said
energy storage means comprising at least one distendable member
superimposed over said base, said member being distendable as a
result of pressure imparted by the fluids to be infused, to
establish internal stresses, said stresses tending to move said
member toward a less distended configuration; (d) container means
interconnectable with said base for filling said fluid reservoir
said container means comprising: (i) a container having a fluid
chamber with first and second open ends; (ii) a plunger
telescopically movable within said container from a first location
proximate said pierceable means to a second, spaced-apart location;
(e) adapter means for interconnecting said container means with
said base, said adapter means comprising: (i) first hollow housing
for receiving said container of said container means, said first
hollow housing having: a. first and second open ends; b. an
intermediate wall disposed between said first and second open ends;
c. a sharp, needle-like hollow cannula connected to and extending
through said intermediate wall for piercing engagement with said
pierceable means of said container assembly; and d. a split cannula
sealably closing said first end of said first hollow housing; (ii)
a second hollow housing for receiving said first hollow housing,
said second hollow housing being receivable within said receiving
chamber of said base to move said split cannula of said first
hollow housing into engagement with said blunt end cannula; and (e)
fluid dispensing means in communication with said outlet of said
fluid reservoir for dispensing fluids from the device.
6. A device as defined in claim 5 further including fluid actuator
means disposed intermediate said fluid outlet of said reservoir and
said fluid dispensing means for visually indicating fluid flow from
said fluid reservoir.
7. A device as defined in claim 6 further including flow control
means disposed intermediate said indicator means and said outlet of
said fluid reservoir for controlling the rate of flow of fluid from
the device.
8. A device as defined in claim 7 in which said indicator means
comprises first and second at least partially overlaying thin
films, said films being movable relative to each other in response
to fluid flowing from said fluid reservoir.
9. A device for use in infusing medical fluids comprising: (a) a
base assembly including: (i) an ullage substrate having a receiving
chamber formed therein; and (ii) a hollow cannula mounted within
said receiving chamber; (iii) a plurality of generally ring shaped
guides mounted within said receiving chamber; (b) stored energy
means for forming in conjunction with said base assembly a fluid
reservoir having an inlet in communication with said hollow cannula
and an outlet, said energy storage means comprising at least one
distendable member superimposed over said base, said member being
distendable as a result of pressure imparted by the fluids to be
infused, to establish internal stresses, said stresses tending to
move said member toward a less distended configuration; and (c)
fill means receivable within said receiving chamber of said base
for filling said fluid reservoir, said fill means comprising a fill
assembly including a container and an adapter subassembly, said
container being telescopically movable within said receiving
chamber from a first position to a second position, said container
also receivable within and guided by said ring shaped guides as
said container moves from said first location to said second
location.
10. A device as defined in claim 9 in which said adapter
subassembly comprises a hollow housing having an elongated
generally cylindrical wall.
11. A device as defined in claim 10 in which said ullage substrate
is provided with an elongated bore having a longitudinally
extending surface and in which said receiving chamber of said
ullage substrate is defined by an elongated, generally
cylindrically shaped inner wall, said inner wall defining in
conjunction with said surface of said bore, an annular space, said
wall of said hollow housing of said adapter subassembly being
telescopically receivable within said annular space.
12. A device as defined in claim 11 further including fluid
actuated indicator means for visually indicating fluid flow from
said fluid outlet of said reservoir.
13. A device as defined in claim 12 further including flow control
means disposed intermediate said indicator means and said outlet of
said fluid reservoir for controlling the rate of flow of fluid from
the device.
14. A device as defined in claim 13 in which said indicator means
comprises first and second at least partially overlaying thin
films, said films being movable relative to each other in response
to fluid flowing from said fluid reservoir.
15. A device for use in infusing medicinal fluid into a patient at
a controlled rate comprising: (a) a reservoir assembly including a
base having a receiving chamber formed therein; (b) stored energy
means for forming, in conjunction with said base a fluid reservoir
having an inlet and an outlet in said stored energy means
comprising at least one distendable member superimposed over said
base, said member being distendable as a result of pressure
imparted by the fluids to be infused, to establish internal
stresses, said stresses tending to move said member toward a less
distended configuration; (c) fluid delivery means in communication
with said outlet of said fluid reservoir for delivery fluid from
the device; (d) flow control means disposed intermediate said
outlet of said fluid reservoir and said fluid delivery means for
controlling the rate of flow of fluid flowing from said fluid
delivery means; (e) closure means connected to said reservoir
assembly for supporting therewithin said fluid delivery means; and
(f) fill means receivable within said receiving chamber for filling
said fluid reservoir, said fill means comprising a container
subassembly, said container assembly comprising: (i) a container
having a fluid chamber with first and second open ends; (ii)
pierceable means for sealably closing one of said first and second
open ends of said container; and (iii) a plunger telescopically
movable within said container from a first location proximate said
pierceable means to a second, spaced-apart location.
16. A device as defined in claim 15 in which said fill means
further comprises an adapter subassembly, said adapter subassembly
including a hollow housing for receiving said container, said
hollow housing having first and second ends.
Description
[0001] This is a Divisional Application of co-pending U.S.
application Ser. No. 09/139,605, filed Aug. 24, 1998; which is a
Divisional Application of U.S. Ser. No. 08/768,663 filed Dec. 18,
1996 now U.S. Pat. No. 5,849,071.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates generally to fluid delivery
devices. More particularly, the invention concerns an improved
apparatus for infusing medicinal agents into an ambulatory patient
at specific visual rates over extended periods of time, which
apparatus includes both flow indicator means and a novel vial
assembly fill means for filling the reservoir of the device.
[0004] 2. Discussion of the Invention
[0005] Many medicinal agents require an intravenous route for
administration thus bypassing the digestive system and precluding
degradation by the catalytic enzymes in the digestive tract and the
liver. The use of more potent medications at elevated
concentrations has also increased the need for accuracy in
controlling the delivery of such drugs. The delivery device, while
not an active pharmacologic agent, may enhance the activity of the
drug by mediating its therapeutic effectiveness. Certain classes of
new pharmacologic agents possess a very narrow range of therapeutic
effectiveness, for instance, too small a dose results in no effect,
while too great a dose results in toxic reaction.
[0006] In the past, prolonged infusion of fluids has generally been
accomplished using gravity flow methods, which typically involve
the use of intravenous administration sets and the familiar bottle
suspended above the patient. Such methods are cumbersome, imprecise
and require bed confinement of the patient. Periodic monitoring of
the apparatus by the nurse or doctor is required to detect
malfunctions of the infusion apparatus.
[0007] Devices from which liquid is expelled from a relatively
thick-walled bladder by internal stresses within the distended
bladder are well-known in the prior art. Such bladder, or "balloon"
type, devices are described in U.S. Pat. No. 3,469,578, issued to
Bierman and in U.S. Pat. No. 4,318,400, issued to Perry. The
devices of the aforementioned patents also disclose the use of
fluid flow restrictors external of the bladder for regulating the
rate of fluid flow from the bladder.
[0008] The prior art bladder type infusion devices are not without
drawbacks. Generally, because of the very nature of the bladder or
"balloon" configuration, the devices are unwieldy and are difficult
and expensive to manufacture and use. Further, the devices are
somewhat unreliable and their fluid discharge rates are frequently
imprecise.
[0009] The apparatus of the present invention overcomes many of the
drawbacks of the prior art by eliminating the bladder and making
use of recently developed elastomeric films and similar materials,
which, in cooperation with a base define a fluid chamber that
contains the fluid which is to be dispensed. The elastomeric film
membrane controllably forces fluid within the chamber into fluid
flow channels provided in the base.
[0010] The elastomeric film materials used in the apparatus of the
present invention, as well as various alternate constructions of
the apparatus, are described in detail in U.S. Pat. No. 5,205,820
issued to the present inventor. Therefore, U.S. Pat. No. 5,205,820
is hereby incorporated by reference in its entirety as though fully
set forth herein. Co-pending U.S. Ser. No. 08/046,438 filed by the
present inventor on May 18, 1993 also describes various alternate
constructions and modified physical embodiments of the invention.
This co-pending application is also hereby incorporated by
reference in its entirety as though fully set forth herein. Because
the present application discloses a novel improvement to the
apparatus described in co-pending U.S. Ser. No. 08/432,221 filed
May 1, 1995, this co-pending application is also hereby
incorporated by reference in its entirety as though fully set forth
herein.
[0011] The apparatus of the present invention can be used with
minimal professional assistance in an alternate health care
environment, such as the home. By way of example, devices of the
invention can be comfortably and conveniently removably affixed to
the patient's body and can be used for the continuous infusion of
antibiotics, hormones, steroids, blood clotting agents, analgesics,
and like medicinal agents. Similarly, the devices can be used for
I-V chemotherapy and can accurately deliver fluids to the patient
in precisely the correct quantities and at extended microfusion
rates over time.
[0012] The embodiments of the invention described in Ser. No.
08/432,221, which application is incorporated herein by reference,
comprises a fluid delivery apparatus having a fluid reservoir,
fluid flow control assembly, and an indicator assembly for
indicating fluid flow through the apparatus. However, unlike the
apparatus of the present invention, which includes a unique vial
fill assembly for filling the reservoir, the reservoir of the
apparatus described in Ser. No. 08/432,221 is filled from an
external fluid source which is connected to a conventional luer
connector provided on the base of the device. As will be better
understood from the description which follows, the novel vial fill
assembly of the present invention significantly expands the
capability of the apparatus, including enabling the reservoir of
the device to be filled at time of usability to controllably fill
the reservoir of the device with a wide variety of medicinal fluids
that can be conveniently stored within the prefilled vial component
of the vial assembly.
SUMMARY OF THE INVENTION
[0013] It is an object of the present invention to provide an
apparatus for expelling fluids at a precisely controlled rate which
is of a compact, low profile, laminate construction. More
particularly, it is an object of the invention to provide such an
apparatus which can be used for the precise infusion of
pharmaceutical fluids to an ambulatory patient at controlled rates
over extended periods of time.
[0014] It is another object of the invention to provide an
apparatus of the aforementioned character which is highly reliable
and easy-to-use by lay persons in a non-hospital environment.
[0015] Another object of the invention is to provide an apparatus
which can be factory prefilled with a wide variety of medicinal
fluids or one which can readily be filled in the field shortly
prior to use.
[0016] A further object of the invention is to provide a low
profile, fluid delivery device of laminate construction which can
be manufactured inexpensively in large volume by automated
machinery.
[0017] Another object of the invention is to provide a device of
the aforementioned character which includes a novel rate control
membrane disposed intermediate the fluid reservoir outlet and the
outlet port of the device.
[0018] Another object of the invention is to provide a device of
the character described which embodies a highly novel fluid flow
indicator that provides a readily discernible visual indication of
fluid flow status through the device.
[0019] Another object of the invention is to provide an apparatus
of the aforementioned character in which the stored energy source
is of a novel laminate construction which can be precisely tailored
to deliver fluid from the device at precise rates.
[0020] Another object of the invention is to provide a unique fill
assembly for use in controllably filling the fluid reservoir of the
apparatus.
[0021] Another object of the present invention is to provide an
apparatus of the aforementioned character in which the fill
assembly comprises a vial assembly that can be prefilled with a
wide variety of medicinal fluids.
[0022] Another object of the present invention is to provide a fill
assembly of the type described in the preceding paragraph in which
the prefilled vial assembly is partially received within the
housing of the fluid dispensing device for operable interconnection
therewith.
[0023] Another object of the invention is to provide an apparatus
as described in the preceding paragraphs which includes locking
means for locking the vial assembly to the fluid delivery assembly
following filling of the fluid reservoir.
[0024] Another object of the invention is to provide a novel vial
assembly for use with the fluid dispenser subassembly of the
apparatus which is easy to use, is inexpensive to manufacture, and
one which maintains the vial in an aseptic condition until time of
use.
[0025] Other objects of the invention are set forth in U.S. Pat.
No. 5,205,820 which is incorporated herein and still further
objects will become more apparent from the discussion which
follows.
[0026] By way of summary, the improved fluid delivery apparatus of
the present form of the invention comprises four cooperating
subassemblies, namely a reservoir assembly, a fluid flow control
subassembly, a flow indicator subassembly and a reservoir fill
assembly. The reservoir subassembly, which readily lends itself to
automated manufacture, is generally similar to that described in
copending Ser. No. 08/432,221 and includes a base and a stored
energy means comprising at least one distendable elastomeric
membrane which cooperates with the base to form a fluid reservoir.
The fluid flow control subassembly is also similar to that
described in Ser. No. 08/432,221 in that it comprises a thin
permeable flow control membrane which controls the rate of flow of
fluid flowing toward the outlet port of the device.
[0027] As will be discussed in greater detail hereinafter, the
highly novel fluid flow indicator means of the invention comprises
a mechanical fluid flow indicator that provides a clear visual
indication of normal fluid flow and absence of fluid flow either
because the reservoir is empty or because the flow lines are
occluded. More particularly, symbols indicating the operating
condition of the device are produced by the movement of thin,
indicia-carrying films. These films, which comprise a part of the
flow indicator means, are shifted by the movement of mechanical
actuators which are deflected solely by the fluid pressure within
the device. The fluid flow indicator design does not invade the
fluid flow path and yet utilizes the same stored energy means to
generate fluid pressure that provides for the normal functioning of
the device. The fluid flow indicator is highly reliable in
operation, can be produced inexpensively, and, because it has very
few parts, is easy to manufacture.
[0028] As previously mentioned, the novel fill assembly for use in
filling the reservoir of the reservoir assembly comprises a novel
vial assembly which can be operably mated with the reservoir
assembly for the controlled filling thereof at time of use.
BRIEF DESCRIPTION OF THE DRAWINGS
[0029] FIG. 1 is an exploded, generally perspective bottom view of
one form of the apparatus of the present invention in which the
reservoir of the fluid delivery device is filled by a vial assembly
of novel construction.
[0030] FIG. 2 is a side-elevational, cross-sectional, exploded view
of the vial assembly shown in FIG. 1.
[0031] FIG. 3 is a side-elevational, cross-sectional view of the
apparatus of FIG. 1 showing the vial assembly coupled with the
reservoir assembly of the fluid delivery device.
[0032] FIG. 3A is a generally perspective exploded view of the
sterile cover subassembly of the invention for closing the vial
assembly receiving chamber of the fluid delivery device.
[0033] FIG. 4 is an enlarged, generally perspective, exploded view
of the vial assembly receiving chamber of the reservoir assembly
showing the vial assembly in position to be mated with the
reservoir assembly.
[0034] FIG. 5 is a cross-sectional view taken along lines 5-5 of
FIG. 3.
[0035] FIG. 5A is a fragmentary, cross-sectional view of the area
designated as 5A in FIG. 5.
[0036] FIG. 6 is a fragmentary, cross-sectional view similar to
FIG. 5, but showing an alternate form of membrane capture
means.
[0037] FIG. 7 is a side-elevational view of an alternate form of
reservoir fill assembly.
[0038] FIG. 8 is a generally perspective bottom view illustrating
the manner of filling the reservoir using the reservoir fill
assembly shown in FIG. 7.
[0039] FIG. 9 is a side-elevational, cross-sectional, exploded view
showing an alternate form of the apparatus of the invention in
which the blunt end cannula of the reservoir assembly has been
replaced with a needle like piercing cannula.
[0040] FIG. 10 is a side-elevational, cross-sectional view of an
apparatus similar to that depicted in FIG. 3, but showing an
alternate form of reservoir fill assembly that uniquely embodies an
adapter subassembly that permits a vial assembly having a
needle-type pierceable septum to be mated with a reservoir assembly
such as shown in FIG. 3 which has a blunt end cannula.
[0041] FIG. 11 is an enlarged fragmentary, cross-sectional view of
a proportion of the adapter subassembly shown in FIG. 10 with a
portion of a vial assembly having a needle piercing cannula mated
therewith.
[0042] FIG. 12 is a generally perspective, exploded view of one
form of the flow control and flow indicator means of the
invention.
[0043] FIG. 13 is a generally perspective, exploded view similar to
FIG. 12 also illustrating the construction of the alternate form of
flow control and indicator means of the invention.
[0044] FIG. 13A is a generally perspective view of one form of the
elastomeric boot component of the indicator means of the invention
which, in response to fluid pressure, acts upon the indicia
carrying means of the flow indicating means.
[0045] FIG. 13B is a fragmentary, generally perspective view
illustrating an alternate form of flow control means of the
invention.
[0046] FIG. 13C is a fragmentary, generally perspective view
illustrating yet another form of flow control means of the
invention.
[0047] FIG. 14 is a fragmentary, side-elevational, cross-sectional
view of still another form of reservoir assembly of an alternate
embodiment of the invention.
[0048] FIG. 15 is a fragmentary, side-elevational, cross-sectional
view similar to FIG. 10, but showing the fill means of this
alternate form of the invention being mated with the reservoir
assembly.
[0049] FIG. 16 is an enlarged, cross-sectional view taken along
lines 16-16 of FIG. 15.
[0050] FIG. 17 is a generally perspective bottom view of an
alternate form of the fluid delivery apparatus of the
invention.
[0051] FIG. 18 is a generally perspective, top view of the
apparatus shown in FIG. 17.
[0052] FIG. 19 is a fragmentary, cross-sectional view of the
forward portion of the form of the fluid dispensing apparatus shown
in FIG. 18.
[0053] FIG. 20 is a front view of the apparatus showing the closure
means of the invention in an open configuration.
[0054] FIG. 21 is a cross-sectional view taken along lines 21-21 of
FIG. 20.
[0055] FIG. 22 is a cross-sectional view taken along lines 22-22 of
FIG. 20.
[0056] FIG. 23 is an enlarged, exploded, cross-sectional view of
the fluid flow control means of this latest form of the
invention.
[0057] FIG. 24 is a view of the flow control means of FIG. 23 shown
in assembled configuration.
[0058] FIG. 25 is an exploded, generally perspective front view of
the support structure of the fluid delivery apparatus of the form
of the invention shown in FIGS. 17 and 18
[0059] FIG. 26 is an exploded, generally perspective, rear view of
the apparatus shown in FIG. 25.
[0060] FIG. 27 is a generally perspective, bottom view of another
form of the apparatus of the invention.
[0061] FIG. 28 is a generally perspective top view of the apparatus
shown in FIG. 27.
[0062] FIG. 29 is a front view of the fluid dispensing apparatus
shown in FIG. 28.
[0063] FIG. 30 is a cross-sectional view taken along lines 30-30 of
FIG. 29.
[0064] FIG. 31 is a fragmentary, cross-sectional view taken along
lines 31-31 of FIG. 29 showing the forward portion of the fluid
delivery apparatus.
[0065] FIG. 32 is a fragmentary top view of the forward portion of
this latest form of the invention showing the circumferentially
extending channel which is provided for storage of the delivery
line of the apparatus.
DESCRIPTION OF THE INVENTION
[0066] Referring to the drawings and particularly to FIGS. 1
through 5, the apparatus of this form of the present invention is
there illustrated and identified generally by the numeral 150. In
order to avoid possible confusion with the numbering of U.S. Ser.
No. 08/432,221, which is incorporated herein by reference,
numbering of the drawings of the application will start with the
numeral 150.
[0067] As best seen in FIGS. 1 and 3, the apparatus here comprises
four major cooperating subassemblies namely, a reservoir
subassembly 150a, a flow rate control subassembly 150b, a flow
indicator subassembly 150c and a fill assembly 150d. Each of these
subassemblies will be discussed in greater detail in the paragraphs
which follow.
[0068] Considering first the reservoir subassembly shown in FIG. 3,
this subassembly includes a base assembly 152, a stored energy
source, shown here as a distendable membrane component 154, and a
cover 156 for enclosing the stored energy source. The base assembly
includes an ullage substrate 158 and a membrane capture housing 160
having a bottom opening 162 which receives the distendable membrane
engaging element or protuberance 164 (see also FIG. 5) of base
assembly 152.
[0069] Referring particularly to FIGS. 3 and 5, the ullage
substrate 158 is provided with fill assembly receiving means shown
here as a longitudinally extending, generally cylindrically shaped
receiving chamber 165 for receiving the fill assembly 150d.
Provided within chamber 165 are the valve and cannula means of the
invention, the nature and purpose of which will presently be
discussed. As best seen by referring to FIGS. 1 and 2, one form of
the fill assembly 150d of the apparatus comprises a container
subassembly 170 and an adapter subassembly 172. Container
subassembly 170 includes a body portion 176, having a fluid chamber
178 for containing an injectable fluid. Chamber 178 is provided
with first and second open ends 180 and 182 (FIG. 2). First open
end 180 is sealably closed by closure means here provided in the
form of a pierceable septum assembly 184 which includes a septum
184a. Septum 184a is pierceable by the cannula means of the
invention which is shown in FIGS. 3 and 4 as a blunt end, hollow
cannula 185. Septum assembly 184 is held securely in position
within open end 180 by clamping ring 186. As best seen in FIGS. 2
and 3, to expel fluid from chamber 178, a plunger 188 is
telescopically movable within the chamber from a first location
where it is proximate second open end 182 to a second position
shown in FIG. 3 where it is proximate first open end 180. The vial
or body portion of the container subassembly 170 can be constructed
of various materials such as glass and plastic.
[0070] Referring particularly to FIG. 2, it can be seen that the
adapter subassembly 172 of this form of the invention comprises a
hollow housing 190 in the manner shown in having a first open end
192 and a second closed end 194. Container subassembly 170 is
telescopically receivable within open end 192 of housing 190 in the
manner shown in the drawings so that the housing can be moved from
the first extended position shown in FIG. 1 to the vial
encapsulation position shown in FIG. 3. Forming an important part
of the adapter subassembly is pusher means shown here as an
elongated pusher rod 196 which functions to move plunger 188 within
fluid chamber 178 from the first position shown in FIG. 1 to the
second position shown in FIG. 3. In the form of the invention shown
in the drawings, pusher rod 196 has a first end 196a interconnected
with closure wall 194 and an opposite end 196b which engages
plunger 188 and causes telescopic movement of the plunger within
chamber 178 of container subassembly 170 as housing 190 is moved
from the extended position shown in FIG. 1 into the vial
encapsulating position shown in FIG. 3.
[0071] As best seen by referring to FIGS. 1 and 3, receivable
within the mouth of chamber 165 of substrate 158 is a retaining
ring 191 having an alignment protuberance 197 which engages and
centers adapter subassembly 172 within chamber 165. Due to the
small surface area presented by protuberance 197, there is little
frictional resistance to the sliding movement of the adapter
subassembly relative to base assembly 152 as the adapter
subassembly is moved from the extended position shown in FIG. 1
into the vial encapsulating position shown in FIG. 3.
[0072] Turning particularly to FIGS. 1, 3, and 3a, it is to be
noted that prior to the fill assembly being inserted into chamber
165, the chamber is maintained in a sterile condition by a sterile
tear-off cover assemble 200 which is bonded or otherwise removably
affixed to retaining ring 191. An integral pull tab 200a is
provided to permit the tear-off cover 200b to be pulled from
retaining ring 191 so as to permit insertion of the fill assembly
into chamber 165. Assembly 200 also includes a resilient tab-like
element 200c (FIG. 3A) which lockably engages saw tooth-like
protuberances 190a formed on adapter subassembly 172 to prevent
removal of the adapter subassembly from chamber 165 after it has
been fully inserted therewithin. As best seen in FIG. 1, a
medicament label 204 circumscribes adapter portion 172 and serves
to identify the contents of container subassembly 170 prior to
mating the fill assembly with the dispensing device. It is also to
be noted that container subassembly 170 is provided with indicator
means shown here as a plurality of spaced-apart index lines 206,
which, by viewing the container assembly through a window 207
provided in substrate 158 (FIG. 1), permit the user to determine
how much fluid remains within the container at any given time.
[0073] As plunger 188 is moved forwardly of container 170 by the
insertion of the fill assembly into chamber 165, the fluid
contained in the container will flow under pressure into passageway
218 via the valve means which is here provided as an umbrella type
check valve 209. As best seen in FIG. 4, valve 209, which is of a
conventional construction, is received within a cavity 165a formed
in the end wall of receiving chamber 165 and is held in position
therewithin by a cylindrically shaped housing 185a having an end
wall 185b which supports cannula 185 in the manner shown in FIG. 4.
Valve 209 is constructed from an appropriate elastomer and has a
resiliently deformable skirt portion 209a which will deform
inwardly within cavity 165a to permit fluid to flow toward the
reservoir of the device, but will block reverse flow. From
passageway 218, the fluid will flow under pressure into reservoir
220 where it will cause the stored energy means or membrane 154 to
distend outwardly from protuberance 158a of ullage substrate 158 in
the manner shown in FIGS. 3 and 5.
[0074] As before, the stored energy means can be in the form of a
single prestressed or unstressed isotropic, elastomeric distendable
membrane, or it can comprise a laminate assemblage made up of a
plurality of initially generally planar distendable elements or
films. In particular, as shown in FIG. 5A, the layer 154a that will
be in contact with the fluid may be a fluoroelastomer coating of
the type made by Lauren International, Inc. that is known by the
tradename Flurolast WB.RTM.. The outer layer 154 can be any
suitable elastomer having the characteristics best suited for the
end application to be made of the device. As previously discussed,
as the distendable membrane 154 is distended by the fluid pressure
exerted by the fluid flowing into the reservoir, internal stresses
are formed therein which continuously urge the assemblage toward
engagement with protuberance 158a as it tends to return toward its
original configuration. As the membrane moves toward protuberance
158a, fluid within reservoir 220 will be uniformly and controllably
forced outwardly through reservoir outlet 222, through passageway
224 and finally through longitudinally extending passageway 226
which is formed in ullage substrate 158.
[0075] As indicated by FIGS. 3 and 5, upstanding tongue 164 of base
152 extends completely about the perimeter of the base and is
closely receivable within a groove 160a of capture housing 160.
When the ullage substrate and the membrane capture housing are
assembled in the manner shown in FIGS. 3 and 5, the periphery of
distendable membrane 154 will be securely clamped within groove
160a by tongue 164. After the parts are thus assembled, housing 160
is bonded to base 152 by any suitable means such as adhesive or
sonic bonding. This done, cover 156 is mated with capture housing
160 in the manner shown in FIGS. 3 and 5 and bonded in place.
[0076] Referring next to FIG. 6, an alternate form of the apparatus
of the invention is there shown. This embodiment is virtually
identical in construction and operation to that shown in FIGS. 3
and 5 save that the base 153 is provided with a pair of
circumferentially extending tongues 153a which tongues are closely
receivable within a pair of grooves 161a provided in the capture
housing 161. With this construction, when the modified ullage
substrate and the modified membrane capture housing are assembled
in the manner shown in FIG. 6, the periphery of distendable
membrane 154 will be securely clamped within grooves 161a by
tongues 153a. After the parts are thus assembled, housing 161 is
bonded to base 153 by any suitable means such as adhesive or sonic
bonding.
[0077] Once again, reference should be made to U.S. Ser. No.
08/432,221 for the various materials that can be used to construct
the base assemblies 152 and 153, the cover 156, and the membrane
capture housings 160 and 161 as identified in the preceding
paragraphs.
[0078] Turning now to a consideration of the important flow rate
control subassembly of this latest form of the invention, this
subassembly is somewhat similar to that previously described and
also includes flow control means which are disposed externally of
reservoir 220 for controlling the rate of fluid flow of fluid from
the device. This flow control means here comprises a rate control
means, here shown as membrane 230 (FIG. 12), which is closely
received within a circular recess 232 formed in support means shown
here as comprising a support structure 234. Rate control membrane
230 comprises a very thin (approximately 0.018 inch thick), rigid
polyester plate having a multiplicity of small laser drilled
orifices 236. It is to be understood that rate control membrane 230
can be constructed from materials other than polyester, including
those materials identified in U.S. Pat. No. 5,205,820 which patent
is incorporated herein by reference.
[0079] Referring to FIG. 13B, an alternate form of the flow control
means of the invention is there shown. This flow control means is
usable with the various components previously described and here
comprises a rate control membrane 230a of slightly different
construction, which is closely received within a circular recess
232 formed in support structure 234 (see FIG. 12). Rate control
membrane 230a comprises a very thin (approximately 0.018 inch
thick), rigid polyester plate having only a single small laser
drilled orifice 236a. This rate control membrane 230a can also be
constructed from various materials including those materials
identified in U.S. Pat. No. 5,205,820.
[0080] Also comprising a part of the flow control means of this
latest form of the invention is a vent patch or membrane 287, which
is of the character previously described, and filter means shown
here as a thin membrane 237. Filter membrane 277 is positioned
proximate rate control membrane 230a and functions to filter
particulates from the fluids flowing from passageway 262 toward
rate control membrane 230a (see also FIG. 13). Filter membrane 237
can be constructed from a number of porous materials such as metal
and ceramics. A polyether sulfone material sold by Gelman Sciences
under the name and style "SUPOR" has also proven satisfactory.
[0081] Turning next to FIG. 13C, still another form of flow control
means of the invention is there shown. This flow control means is
also usable with various components previously described and here
comprises frit or rate control membrane 230a which is also closely
received within a circular recess form in support structure 234
(see FIG. 13). Rate control frit 230b here comprises a rigid,
porous glass frit of a character well known in the art which can be
tailored to provide the desired flow rate.
[0082] Also comprising a part of the flow control means of this
latest form of the invention is a small version of the previously
identified membrane 287, here identified as 287a. Also forming a
part of this flow control means is the previously identified filter
membrane 237. Filter membrane 277 is positioned proximate rate
control frit 230b and, as before, functions to filter particulates
from the fluids flowing from passageway 262 toward rate control
frit 230b (see FIG. 13).
[0083] Support structure 234 includes an outwardly extending
generally cylindrically shaped, fluid inlet element 240 (FIG. 13)
which is provided is a fluid passageway 242. Passageway 242 is
adapted to communicate with reservoir 220 via passageways 224 and
226 when support structure 234 is mated with base assembly 152. As
best seen in FIG. 3, base assembly 152 has a centrally disposed
socket-like recess 244 that closely receives inlet element 240 when
structure 234 is mated with base assembly 152.
[0084] Formed on either side of element 240 are wing-like
protuberances 248 (FIG. 13) which are received within spaced-apart,
arcuate-shaped cavities formed in base assembly 152 (not shown).
Located proximate the upper edge of support structure 234 are
arcuately, spaced-apart connector members 252 which mate with
arcuately spaced openings 254 provided on cover 156 to enable
secure interconnection of support structure 234 with the reservoir
assembly.
[0085] As shown in FIG. 3, when the support structure 234 is mated
with the reservoir assembly, fluid inlet passageway 242 is placed
in fluid communication with reservoir 220 via passageways 224 and
226. With this construction, when fluid is forced through fluid
passageway 242 of inlet 240 by the stored energy means, the fluid
will flow into a vertically extending passageway 256 formed in a
thin manifold plate 260 (FIG. 13) which is closely receivable
within a similarly shaped cavity 261 formed in the forward face of
element 234 (FIG. 12). Next, the fluid will flow into a
horizontally extending passageway 262 formed in manifold plate 260
and finally into a chamber 264 formed in a distendable, elastomeric
first boot 266 of the flow indicator means of the invention. As
shown in FIG. 13A, boot 266 includes a yieldably distendable fluid
flow blocking body portion 266a which is circumscribed by a
marginal portion 266b. Marginal portion 266b is clamped between
manifold plate 260 and a uniquely configured indicator base 268 so
that the boot extends through a generally arcuate-shaped opening
268a formed in the indicator base 268. It is to be understood that,
when the fluid flowing from reservoir 220 fills passageways 256 and
262 and impinges upon boot 266, flow will be diverted back in the
direction of arrows 269 of FIGS. 12 and 13 toward support structure
234 and into a chamber 270 which is formed in the rear surface of
the support structure (FIG. 13). Chamber 270 is adapted to closely
receive an angularly shaped insert 271 of the character shown in
FIG. 12. As shown in FIG. 12, insert 271 includes a horizontally
extending fluid passageway 272 having an inlet end 272a and an
outlet end 272b. Insert 271 also has a vertically extending fluid
passageway 274 having an upper inlet end 274a and a lower outlet
end 274b which terminates in a socket-like cavity 276. Cavity 276
is in communication with a tubular quick-connect coupling 280
formed on support structure 234 (FIG. 12). In a manner presently to
be described, tubular extension 280 is adapted to mate with a quick
disconnect outlet adapter 280a which is, in turn, connected to the
fluid delivery line 281 of the apparatus (FIG. 1).
[0086] It is to be observed that fluid which is diverted back from
boot 266 toward support structure 234, will flow in the direction
of the arrow 269 of FIG. 13, through rate control element 230, and
then into inlet end 272a of passageway 272 formed in insert 271.
After flowing through rate control element 230, the fluid will next
flow along passageway 272 toward the outlet end 272b in the
direction of arrow 283 (FIG. 13) and then outwardly of the
passageway through an outlet port 284 formed in support structure
234. Next, the fluid will flow forwardly in the direction of arrow
286 through an orifice 288 formed in plate 260 where it will
impinge on a second elastomeric, distendable boot 286 which also
forms a part of the indicator means of the invention. Indicator
boot 286, which is of identical construction to boot 266, is
clamped within an oval shaped opening 268b formed in indicator base
268. After impinging on boot 286, the fluid will next flow back
toward support structure 234 in the direction of arrow 287, through
a lower orifice 290 formed in plate 260 and then, via orifice 291
formed in structure 234, into the upper inlet end 274a of
passageway 274 which is formed in insert 271. Upon entering
passageway 274, the fluid will flow downwardly of the passageway
into cavity 276 and then into tubular extension 280 where it can
enter the quick disconnect outlet adapter 280a and finally delivery
line 281.
[0087] It is to be noted that fluid flowing from reservoir 220 into
passageway 240 and then on toward boot 266 is under a higher
pressure than fluid flowing toward boot 286. This is because the
pressure of the fluid flowing toward boot 286 has been reduced as a
result of the fluid flowing through rate control element 230. It
should also be noted that vent means, shown here as a vent patch
287, is provided in the system to permit air trapped within the
flow control assembly to be vented via a port 289 formed in plate
260.
[0088] Next to be considered is the important flow indicator means
of the invention, which functions to distinguish among three
conditions of operation, namely normal fluid flow, fluid flow
blockage or occlusion, and reservoir empty. Turning particularly to
FIGS. 3, 12, and 13, the flow indicator means here comprises the
previously identified indicator base or platform 268, as well as
the boot clamping plate 260. Additionally, the indicator means
comprises a support or lens plate 300, and a hollow housing 302
within which the platform and the support plate are enclosed (FIG.
3). As seen in FIG. 3, a viewing lens 301 is viewable through an
aperture 302a provided in housing 302.
[0089] Disposed between platform 268 and plate 300 are first and
second indicia-carrying means shown here as a pair of closely
adjacent, thin films. These films, identified here as 306 and 308,
are in intimate contact and are preferably constructed from a
substantially transparent, flexible polymer material such as mylar.
It is to be understood that the indicia-carrying means need not be
thin films, but rather can be any type of surface presenting member
upon which indicia can be provided. The downstream surface of the
inferior or first film 306 is printed with three integrated symbols
307 (FIG. 12), which may comprise, by way of example, a blue
circle, a green arrow, and a red X, each consisting of diagonal
strips of color printed in an alternating pattern (blue, green,
red, blue, green, red, and so on (see also FIGS. 25 through 29 of
U.S. Ser. No. 08/432,221 which is incorporated herein by
reference). The second film 308 serves as a "mask" over film 306
and is printed with a pattern of diagonal alternating clear and
opaque strips 308a that occur in approximately a 1:2 ratio. The
printed ratio of the "mask" allows only one colored symbol to
appear at a time when viewed through viewing lens 301. The inferior
and superior films are provided at their opposite ends with
apertures 310 which receive retention pins 312 provided on platform
268 (FIG. 12) which permit attachment of the film to platform 268
in a manner such that the non-patterned portions of each film
covers boot openings 268a and 268b provided proximate each end of
platform 268 with the patterned portions of both the superior and
inferior films being maintained in index. With this construction,
each thin film is able to move in response to pressure exerted
thereon by the elastomeric boots in opposing directions parallel to
the film plane with its range of motion limited to one axis in the
film plane by edge guides 318 provided on platform 268 (FIG. 12).
As the films move, the visible symbol pattern will, of course,
change due to the transverse displacement of the patterns imprinted
thereon.
[0090] As is apparent from a study of FIG. 13, the central portions
of both the first and second elastomeric actuator elements or boots
266 and 286 will be deflected outwardly toward plate 300 when the
device is filled and primed, but not in a state of delivery or when
there is a build up of fluid pressure during delivery that is
caused by blockage of the delivery line downstream from boot 286.
While boot 266 can be deflected by normal line pressure, boot 286
is deflected only by pressure buildup resulting from the downstream
blockage. When both elastomeric boots 266 and 268 are deflected
outwardly, both the superior and inferior films are displaced
transversely to a second position revealing a second symbol, as for
example, an X as viewed through the viewing aperture of the support
plate (see also FIGS. 28 and 29 of U.S. Ser. No. 08/432,221 which
is incorporated herein by reference).
[0091] A third alignment of symbol patterns as shown in FIGS. 24
and 25 of U.S. Ser. No. 08/432,221 (which is incorporated herein by
reference) is visible when the device is in an unfilled state or
when the delivery line is open, the reservoir is empty and fluid
delivery to the patient has been completed. In this case, there is
no fluid pressure in the line on either the upstream or the
downstream side of the flow control means and thus both the first
and second boots are in a non-deflected position. In this
condition, the inferior and superior films are not transversely
displaced and thus exhibit a third combination of patterns
resulting in a third symbol as, for example, a circle being visible
through the viewing aperture of the support plate. Boots 266 and
286 can be precisely tailored to deflect under various pressures
thereby permitting great apparatus versatility.
[0092] Turning next to FIGS. 7 through 9, still another form of the
apparatus of the invention is there shown and generally designated
by the numeral 330. This embodiment is similar in many respects to
the embodiment shown in FIGS. 1 through 8 and like numerals have
been used to identify like components. More particularly, only the
reservoir and fill subassemblies of the device have been modified,
with the flow rate control subassembly and the indicator
subassembly of the device remaining unchanged.
[0093] With regard to the modified reservoir subassembly which is
shown in FIG. 9, this subassembly includes a base assembly 332, a
distendable membrane component 154, and a cover 156 for enclosing
the membrane. While the base assembly 332 includes a slightly
modified ullage substrate 334, the membrane capture housing 160 is
virtually identical to that previously described and includes a
bottom opening 162 which receives the basically unchanged
distendable membrane engaging element or protuberance 164 of base
assembly 332. As before, the modified ullage substrate 334 is
provided with fill assembly receiving means shown here as a
longitudinally extending, generally cylindrically shaped receiving
chamber 336 for receiving the fill assembly 340 which is also of a
slightly different construction from that shown in FIGS. 1 through
8. As best seen in FIG. 9, the cannula means of the latest form of
the invention comprises a sharp, needle-like, hollow cannula 342,
rather than a blunt end cannula.
[0094] The fill assembly 340 of this latest embodiment of the
invention comprises a container subassembly 344 and an adapter
subassembly 346. Container subassembly 344 includes a body portion
348, having a fluid chamber 350 for containing an injectable fluid
"F". Chamber 350 is provided with first and second open ends 352
and 354. First open end 352 is sealably closed by closure means
here provided in the form of a pierceable septum assembly 356 which
includes a septum 358. Septum 358 is pierceable by the needle-like
sharp cannula mounted within receiving chamber 336. Septum 358 is
held securely in position within open end 352 by clamping ring 360.
As before, in order to expel fluid from chamber 350, a plunger 188
is telescopically movable within the chamber from a first location
where it is proximate second open end 354 to a second position
where it is proximate first open end 352.
[0095] The adapter subassembly 340 of this form of the invention
comprises a hollow housing 364 having a first open end 366 and a
second closed end 368. Container subassembly 344 is telescopically
receivable within open end of chamber 336, then the adapter
subassembly 340 is introduced to open end of chamber 336 when
pusher rod engages plunger of vial. Adapter subassembly 340 also
includes an elongated pusher rod 370 which functions to move
plunger 188 within fluid chamber 350 from a first extended position
to the second position proximate septum assembly 356 as the fill
assembly is mated with the reservoir assembly.
[0096] As best seen in FIG. 9, provided within chamber 336 is an
inner cylindrically shaped wall 336a which is concentric with the
inner wall 336b of receiving chamber 336, forms an integral part of
ullage substrate 334 and is radially spaced from the inner wall
336b of chamber 336 so as to define a longitudinally extending
annular space 336c. With this construction, during the mating of
the reservoir fill assembly with the reservoir assembly, the outer
wall 364a of hollow housing 364 is closely receivable within space
336c as the adapter subassembly is urged inwardly of chamber 336.
At the same time that wall 364a moves forwardly of annular space
336c, the container assembly telescopes inwardly of hollow housing
364 and is guided thereby so as to move septum 358 into piercing
engagement with sharp end cannula 342.
[0097] Prior to the reservoir fill assembly being mated with the
reservoir assembly, chamber 336 is maintained in a sterile
condition by a sterile tear-off cover assembly 374 which is bonded
or otherwise removably affixed to the wall of a counter bore 376
formed in ullage substrate 334. An integral pull tab 374a is
provided to permit the cover 374b to be pulled free so as to permit
insertion of the reservoir fill assembly into chamber 336. Cover
assembly also includes an inwardly extending tab 374c which engages
teeth-like protuberances 357 formed on wall 364a of the fill
adapter so as to prevent removal thereof after the fill assembly
has been mated with the reservoir assembly.
[0098] As plunger 188 of the container assembly is moved forwardly
of container 344 by pusher rod 370, the fluid contained in the
container will flow under pressure into a passageway 380 via hollow
cannula 342 and via an umbrella type check valve 382 which is of
similar construction and operation to valve 209. Valve 382 is
received within a cavity 332a formed in the end wall of receiving
chamber 336 and is held in position therewithin by a disc-shaped
member 384 which supports cannula 342 in the manner shown in FIG.
9. Valve 382 is constructed from an appropriate elastomer and has a
resiliently deformable skirt portion 382a which will deform
inwardly within cavity 332a to permit fluid to flow toward the
reservoir of the device but will block reverse flow. From
passageway 380, the fluid will flow under pressure into reservoir
390 where it will cause the stored energy means or membrane 154 to
distend outwardly from ullage substrate 334 n the manner shown in
FIG. 9.
[0099] After the reservoir has been filled and as membrane 154
moves toward substrate 334 during the fluid dispensing step, fluid
within reservoir 390 will be uniformly and controllably forced
outwardly through reservoir outlet 392, through a passageway 394
and then into passageway 242 of the fluid inlet to substrate 234 of
the flow control means (see for example FIG. 3).
[0100] As shown in FIG. 9, the embodiment of this latest form of
the invention also includes a uniquely designed auxiliary filling
means mounted on ullage substrate 334 which enables filling of
reservoir 390 other than by mating the fill assembly 340 with the
reservoir assembly. This auxiliary filling means here comprises a
generally cylindrically shaped housing 402 having a fluid inlet
402a and a fluid outlet 402b in communication with reservoir 390.
Housing 402 terminates at its inlet end in a conventional luer type
connector end 404 and includes valve means for controlling fluid
flow between inlet 402a and outlet 402b. Valve means 400 here
comprises a valve seat 406 which is adapted to sealably engage a
tapered shoulder 408 formed on a generally cylindrically shaped
valve member 410. Valve member 410 is mounted within housing 402
for reciprocal movement therewithin between a valve closed position
shown in FIG. 9 and a valve open position wherein tapered surface
408 is moved away from valve seat 406 a distance sufficient to
permit fluid flow toward reservoir 390. An apertured cover 412
closes the upper open end of housing 402 with the aperture 414
which is provided therein in alignment with a reservoir inlet
passageway 416.
[0101] In using the auxiliary fill means of the invention, a
sanitary closure cap 417, which is temporarily received over luer
connector end 404 is first removed. This done, a conventional
luer-type connector can be interconnected with end 404 of housing
402 so as to open communication between the interior of housing 402
and a conventional fill line interconnected with the luer connector
(not shown). The luer connector and fill line is of standard
construction and, in this instance, includes an outwardly extending
pintle which engages valve member 410 as the luer connector is
mated with housing 402 so as to move valve member 410 into its
second open position permitting fluid to flow from the fluid
delivery line past valve member 410 and into reservoir 390 via
inlet 416. Such a luer connector construction is well understood by
those skilled in the art. It is to be observed that the auxiliary
fill means can be used as the primary fill means for filling the
reservoir or, alternatively, can be used to add an appropriate
additive fluid to fluid earlier dispensed into the reservoir 390 by
the vial-type fill assembly 340.
[0102] Referring next to FIGS. 7 and 8, still another form of fill
means of the invention is there shown. This alternate fill means
comprises a pistol grip-type fill device 420 which is usable with a
reservoir assembly of the character shown in FIG. 8 which is
similar in construction to the reservoir assembly shown in FIG. 9.
As best seen in FIG. 7, fill device 420 includes a hollow barrel
portion 422 and an interconnected hand grip portion 424. Provided
at the forward end of barrel portion 422 is a septum assembly 426
which includes a pierceable septum of the same general character as
pierceable septum 358 shown in FIG. 9. Provided at the opposite end
of barrel 420 from septum assembly 426 is a connector means 428 for
interconnecting the interior of barrel portion 422 with a fill line
430 which is, in turn, connected to a pressurized source of
medicinal fluid of the character to be used in the filling of
reservoir 390.
[0103] The fill means of this latest form of the invention is used
in connection with the modified reservoir assembly shown in FIG. 9
by holding the reservoir in one hand in the manner shown in FIG. 8.
With the pistol grip fill means held in the other hand as shown in
FIG. 8, barrel 422 is inserted into chamber 336 and pushed
forwardly of the base assembly to cause cannula 342 to pierce
septum assembly 426 thereby opening communication between supply
line 430 and reservoir 390 of the reservoir subassembly. It is to
be understood that the reservoir assembly usable with the pistol
grip filling means shown in FIG. 7 can also be of the character
shown in FIG. 4 which is provided with a blunt end cannula 185
rather a needle-like cannula 342 as shown in FIG. 8. In this
instance, the septum assembly 426 will, of course, embody a split
septum rather than a needle-piercing septum so as to accommodate
the blunt-end cannula.
[0104] Turning next to FIGS. 10 and 11, still another embodiment of
the invention is there shown and generally designated by the
numeral 440. This embodiment is also similar in many respects to
the embodiment shown in FIGS. 1 through 8 and like numbers have
been used to identify like components. More particularly, only the
fill assembly 444 and the housing 442, which supports the blunt end
cannula 185, have been modified with the remainder of the device
remaining unchanged. The main purpose of this latest embodiment of
the invention is to provide means for coupling a container assembly
having a standard needle piercing septum with a reservoir assembly
having a blunt end cannula.
[0105] As shown in FIG. 10, modified housing 442 of the reservoir
assembly of this latest form of the invention supports the blunt
end cannula 185 in the manner previously described. However, the
inner wall 442b of the skirt portion 442a thereof is provided with
a circumferentially extending bead or protuberance 442c which, in a
manner presently to be described, lockably engages a portion of the
modified fill assembly 444.
[0106] The modified fill assembly 444 of the form of the invention
shown in FIGS. 10 and 11 comprises a hollow housing 448 having a
first open end 450 and a closed second end 452. The container
subassembly, which is of identical construction to the container
subassembly 340 shown in FIG. 9, is telescopically receivable
within the open end 453a of a second housing 453 which is, in turn,
receivable within housing 448 in the manner shown in FIG. 39.
Second housing 453 is of a novel generally cylindrically shaped
construction of a character presently to be described. As shown in
FIG. 10, assembly 444 includes an elongated pusher rod 454 which,
as the fill assembly is mated with the reservoir assembly,
functions to move plunger 188 of the container subassembly
telescopically of fluid chamber 350 from a first extended position
to the second position proximate septum assembly 356.
[0107] As best seen by referring to FIG. 11, second housing 453
includes a hollow, central body portion 460 and a forward end
portion 462 having an open end 462a and a circumferentially
extending bead or protuberance 462b surrounding open end 462a.
Sealably closing open end 462 is a split septum 464 which is of a
conventional construction adapted to sealably receive a blunt end
cannula such as cannula 185 which is carried by modified housing
442.
[0108] Extending through and supported by a wall 466 which divides
body portion 460 and forward portion 462 of second housing 453 is a
sharp needle-like hollow cannula 470 which is adapted to sealably
pierce septum 358 of container assembly 340.
[0109] In using the apparatus of this latest embodiment of the
invention, container assembly 340 is first inserted into open end
453a of second housing 453 and is urged forwardly to the position
shown in FIG. 11 wherein needle-like cannula 470 pierces septum
358. This step opens communication between fluid chamber 350 of the
container assembly and a subchamber 471 formed in the forward
portion 462 of second housing 453 and in communication with chamber
473 which sealably receives split septum 464. After removing a
protective cap 472 which closes open end 462a of forward portion
462, the assembly made up of second housing 453 and fluid container
assembly 340 is mated with hollow housing 448. The assemblage is
then urged forwardly of chamber 165 which causes pusher rod 454 to
move plunger 188 of the container assembly forwardly of chamber
350. As the assemblage seats the split septum 464 will be sealably
pierced by blunt end cannula 185. This step opens fluid
communication between chamber 350 of the container subassembly and
chamber 332a which houses check valve 382. As before, as the fluid
contained within chamber 350 of the container subassembly is urged
outwardly of the container by forward movement of plunger 188, the
fluid contained within the container assembly will flow through
hollow needle 470, through hollow blunt end cannula 185, past
umbrella check valve 382 and into reservoir 220 via inlet portion
218. As shown in FIG. 10, when the fill assembly seats within
receiving chamber 165, protuberance 462b formed on second housing
453 will move past protuberance 442c formed in skirt 442a of the
cannula support housing thereby locking second housing 453 against
removal from the reservoir assembly. Similarly, tab 374c formed on
closure cap assembly 374 will lockably engage the saw tooth shaped
protuberance 475 formed on housing 448 so as to prevent removal of
housing 448 from the reservoir assembly.
[0110] It is apparent that with this latest embodiment of the
invention, a container subassembly of the character shown in FIG. 9
which has a standard septum 358 can be readily mated with an
apparatus of the character shown in FIG. 10 which embodies a blunt
end cannula 185, without having to modify either the container
subassembly or the reservoir assembly.
[0111] Turning to FIGS. 14, 15, and 16, yet another embodiment of
the invention is there illustrated. This embodiment is generally
similar to the embodiment shown in FIG. 9 save that the reservoir
assembly does not include the secondary fill means and save for the
fact that the cannula means is of a slightly different
construction. Also different from the embodiment of the invention
shown in FIG. 9 is the fill means of the invention which is here
designed to accommodate a fluid container subassembly which has a
diameter substantially less than the internal diameter of wall 336a
of the base assembly. Because of the similarity of construction,
like numerals are used to identify like components.
[0112] As best seen in FIG. 15, to accommodate a smaller diameter
container assembly of the character there shown, a plurality of
ring-like guide members 480 are positioned at longitudinally spaced
apart locations along inner wall 336a. Each of these ring-shaped
guide members 480 includes a plurality of circumferentially spaced,
resiliently deformable tabs 480a which extend inwardly relative
from wall 336a and function to guidably engage the outer wall of
body portion 482 of the fluid container assembly 484 of this latest
form of the invention (FIG. 15). Container assembly 484 includes a
septum assembly 356 of the same general construction as shown in
FIG. 9, the pierceable septum 358 of which is adapted to be pierced
by the sharp end, needle-like cannula 342 which is supported by a
slightly differently configured cannula support 493. As before, a
plunger 486 of the container assembly is moved longitudinally of
fluid chamber 488 by a pusher rod 490 which forms a part of the
hollow housing 492 of the adapter portion of the fill means. As
before, as housing 492 of the fill means is inserted into annular
space 336c in the manner shown in FIG. 15, pusher rod 490 will move
plunger 486 forwardly of the fluid container assembly causing fluid
flow through cannula 342, past check valve 382, and into fluid
reservoir 390 via an inlet 494. As adapter sleeve 492 is mated with
the reservoir assembly, the fluid container assembly will remain
perfectly centered with respect to pusher rod 490 due to the
guiding action of tabs 480a of guide rings 480.
[0113] Turning next to FIGS. 17 through 26, yet another form of the
apparatus of the invention is there shown and generally identified
by a numeral 500. This form of the apparatus is similar to that
illustrated in FIGS. 1 through 5 and like numbers are used to
identify like components. However, in this latest embodiment only
three major cooperating subassemblies are provided, namely, a
reservoir subassembly 500a, a flow rate control subassembly 500b
(FIG. 24), and a fill assembly 500c (FIG. 18). An important feature
of this latest embodiment is the provision of a highly novel
closure means for closing the forward end of the device. This
closure means, which is best seen in FIGS. 18 and 19 and is
generally designated therein by the numeral 517. This important
closure means will be further described in the paragraphs which
follow.
[0114] As indicated in FIG. 19, the reservoir subassembly 500a of
this latest embodiment is quite similar to that shown in FIG. 3 and
includes a base assembly 502, a stored energy source, shown here as
a distendable membrane component 504, and a cover 506 for enclosing
the stored energy source in the manner previously discussed. The
base assembly, only a portion of which is shown in FIG. 19, is of
the same basic design as base assembly 152 and includes an ullage
substrate 508 as well as a membrane capture housing 510 which is of
identical construction to previously described capture housing 160.
Housing 510 includes a bottom opening 512 which receives the
distendable membrane engaging element or protuberance 514 (see also
FIG. 5) of base assembly 502.
[0115] As before, ullage substrate 508 is provided with fill
assembly receiving means which takes the form of a longitudinally
extending, generally cylindrically shaped receiving chamber which
is similar in construction to previously described chamber 165
(FIG. 3), and which function to receive a fill assembly 500c which
assembly is identical to fill assembly 150d. Valve and cannula
means of identical construction and operation to that previously
described are disposed within the fill assembly receiving chamber
and cooperate with the fill assembly to fill reservoir 515.
[0116] As in the earlier discussed embodiments, the stored energy
means can take the form of a single prestressed or unstressed
isotropic, elastomeric distendable membrane, or it can comprise a
laminate assemblage made up of a plurality of initially generally
planar distendable elements or films. As the distendable membrane
154 is distended by the fluid pressure exerted by the fluid flowing
into reservoir 515, internal stresses are formed therein which
continuously urge the assemblage toward engagement with
protuberance 508a (FIG. 19) as it tends to return toward its
original configuration. As the membrane moves toward protuberance
508a, fluid within reservoir 515 will be uniformly and controllably
forced outwardly through reservoir outlet 518, through passageway
520 and finally through a longitudinally extending passageway 522
which is formed in ullage substrate 508 (FIG. 19).
[0117] As previously discussed, the upstanding tongue of base 502
extends completely about the perimeter of the base and is closely
receivable within a groove 510a provided in capture housing 510.
When the ullage substrate and the membrane capture housing are
assembled in the manner shown in FIGS. 19, 3 and 28, the periphery
of distendable membrane 504 will be securely clamped within groove
510a by tongue 514. After the parts are thus assembled, cover 506
is mated with the capture housing 510 in the same manner as is
shown in FIGS. 3 and 5 and then is suitably bonded in place.
[0118] Turning now to a consideration of the important cover means
of this latest form of the invention, this means here comprises a
housing assembly 528 which is interconnected with the reservoir
subassembly 500a and functions to close the forward or delivery end
of the device (see FIGS. 18 and 19). As best seen in FIG. 19,
housing assembly 528 includes a first or forward compartment 528a
and a second, or rearward compartment 528b. Rearward compartment
528b houses a support structure 530, which is generally similar in
construction to support structure 234 (FIG. 3). Like support
structure 234, support structure 530 includes an outwardly
extending, generally cylindrically shaped, fluid inlet element 532
within which is provided a fluid passageway 534. When support
structure 530 is mated with base assembly 502, passageway 534 will
communicate with reservoir 515 via passageways 520 and 522. As
before, base assembly 502 has a centrally disposed, socket-like
recess 535 that closely receives inlet element 532 when structure
530 is mated with base assembly 502 in the maimer shown in the
drawings.
[0119] The flow control means of this latest form of the invention
for controlling the rate of fluid flow of fluid from the device
here comprises a novel flow control assembly 540 of the character
shown in FIGS. 23 and 24. As best seen in FIGS. 21 and 22, a rate
control assembly 540 is mounted within a socket like portion 542
formed in an insert 544 which is received within a cavity 546
formed in the forward wall 530a of support structure 530 (see FIG.
26). Insert 544, in cooperation with a fluid passageway 548 formed
in support structure 530, functions to provide a fluid flow path
between reservoir 515 and the flow control assembly 540. More
particularly, assembly 540 here comprises a quick disconnect
housing 550 which has a central fluid passageway 552 having an
inlet 554 which communicates with passageway 548 in the manner
shown in FIGS. 21 and 22.
[0120] Interconnected with quick disconnect housing 550 is a
delivery line housing 556 to which a delivery line 558 is sealably
connected. Disposed within housing 556 is an elastomeric
compression ring 560 which sealably receives the flow rate control
means of this form of the invention, which means is here provided
as a generally cylindrically shaped rate control frit 562. Also
forming a part of the flow control means of this latest embodiment
is filter means, here shown as a filter element 564 which is
disposed between frit 562 and quick disconnect housing 550 (FIG.
24). Frit 562 and filter element 564 are preferably constructed
from the same type of materials as previously identified herein in
connection with the discussion of elements 237 and 239.
[0121] When insert 544 is in position within cavity 546 in the
manner shown in FIG. 22, quick connect socket portion 542 extends
into forward chamber 528a of the closure means. With this
construction, the flow control means can be placed in fluid
communication with the fluid reservoir of the device by inserting
quick disconnect housing 550 into socket portion 542 and then
turning it in conventional fashion to securely lock it in position.
To prevent leakage of fluid between housing 550 and socket portion
542 an elastomeric O-ring 565 is provided in housing 550 (FIGS. 23
and 24).
[0122] Connected to the flow control means is the fluid delivery
means of the invention. This latter means, which is uniquely
removably stowed within first or forward compartment 528a of the
closure means, here comprises a delivery line luer assembly 570 and
a line clamp 572 both of which are of conventional construction.
Previously identified delivery line 558 is interconnected with luer
assembly 570 in the manner shown in FIG. 18. Disposed between the
flow control means and luer assembly 570 is a vent means shown here
as a conventional gas vent assembly 574 for venting gases trapped
within the system to atmosphere.
[0123] Forward compartment 528a is formed within an access door 576
which is connected to that portion of the rearward portion of
housing 528 which defines rearward compartment 528b, by hinge means
here shown as a pair of living hinge elements 577. With this
arrangement, door 576 can be pivoted relative to the reservoir
assembly from the closed position shown in FIG. 19 to the open
position shown in FIG. 18. Door 576, which forms a part of closure
means 517, includes a front face 576a which, in cooperation with an
interconnected circumscribing wall 576b, forms forward compartment
528a (FIGS. 18 and 20). Latching means, shown here as comprising an
arcuate protuberance 579 formed on housing 528, and an arcuate
locking tab 581 formed on door 576, cooperate to latchably maintain
the door in a normally closed condition (FIG. 19). With this novel
arrangement, the delivery means of the invention can remain
securely stowed within compartment 528a until time of use.
[0124] Turning next to FIGS. 27 through 31, still another form of
the apparatus of the invention is there shown and generally
identified by a numeral 600. This form of the apparatus is somewhat
similar to that illustrated in FIGS. 17 through 25 and like numbers
are used to identify like components. In this latest embodiment
three major cooperating subassemblies are provided, namely, a
reservoir subassembly 600a, a flow rate control means 600b (FIG.
24) and a fluid delivery means 600c which is of the same basic
character as is shown in FIGS. 17 and 18. An important feature of
this latest embodiment is the provision of a closure means of a
slightly different construction for closing the forward end of the
device and for stowing the delivery means in cavities provided in
the face of the closure means. This closure means, which is best
seen in FIG. 27 will be further described in the paragraphs which
follow.
[0125] As indicated in FIG. 29, the reservoir subassembly 600a of
this latest embodiment is virtually identical to reservoir
subassembly 500a and, therefore, will not here be described in
further detail. Suffice to say that the reservoir subassembly
includes a stored energy source, shown as a distendable membrane
component 504, and a cover 506 for enclosing the stored energy
source in the manner previously discussed. The base assembly, only
a portion of which is shown in FIG. 29, is of the same basic design
as base assembly 522 and includes an ullage substrate 608 as well
as a membrane capture housing 510 which is of identical
construction to previously described capture housing 160. Since in
this embodiment the reservoir is filled by an external fill line,
or the like, no container type fill means is provided and,
accordingly, the ullage substrate has no fill assembly receiving
chamber. Reference should be made to FIG. 3B of Ser. No. 08/432,221
which is incorporated by reference, wherein the details of
construction of the fill means of this latest form of the invention
is shown.
[0126] With regard to the cover means of the form of the invention
shown in FIGS. 27 and 28, this means here comprises a housing
assembly 628 which is interconnected with the reservoir subassembly
600a and functions to close the forward or delivery end of the
device (see FIGS. 29 and 30). As best seen in FIG. 29, housing
assembly 628 includes a first or forward compartment 628a and a
second, or rearward compartment 628b. Rearward compartment 628b
houses a support structure 530, which is generally similar in
construction to support structure 234 (FIG. 3). Like support
structure 234, support structure 530 includes an outwardly
extending, generally cylindrically shaped, fluid inlet element 532
within which is provided a fluid passageway 534. When support
structure 530 is mated with base assembly 502, passageway 534 will
communicate with reservoir 515 via passageways 520 and 522. As
before, base assembly 502 has a centrally disposed, socket-like
recess 535 that closely receives inlet element 532 when structure
530 is mated with base assembly 502 in the manner shown in the
drawings.
[0127] The flow control means of this latest form of the invention
for controlling the rate of flow of fluid from the device is
substantially identical to that previously described and comprises
a rate control frit 562 and a filter element 564 (FIG. 59). These
elements function in the manner described in connection with FIGS.
46 through 54 and are assembled together in the manner shown in
FIGS. 23 and 24.
[0128] Interconnected to a quick disconnect housing 550 of the
character previously described is a delivery line housing 556 to
which a delivery line 558 is sealably connected (FIG. 30). As
before, when the various components of the flow control assembly
540 are interconnected in the manner shown in FIG. 23 and when the
assembly is in position within socket portion 542, the flow control
means is in fluid communication with the fluid reservoir 515 of the
device.
[0129] In addition to delivery line 558, the fluid delivery means
of this latest form of the invention also comprises a delivery line
luer assembly 570 and a line clamp 572 both of which are of the
character previously described. Disposed between the flow control
means and luer assembly 570 is a vent means shown here as a
conventional gas vent and filter assembly 574, which is also of the
character previously described.
[0130] As best seen in FIGS. 28, 30, and 31, the front face 628c of
forward compartment 628a is formed with a plurality of cavity-like
recesses which receive portions of the delivery means. More
particularly, face 628c has formed therein a cavity 570a which
closely receives luer assembly 570, a cavity 572a which closely
receives clamp 572 and a cavity 574a which closely receives gas
vent assembly 574. Turning to FIG. 31, it is to be noted that
delivery line 558 extends downwardly of forward compartment 628a
and passes through an opening 575. The line can then be uniquely
wound around housing 628 so that it safely resides within a
circumferentially extending channel 577 provided in the housing
(FIGS. 28, 31, and 32). With this novel arrangement, until the
device is to be used, the luer assembly 570, the roller clamp 572,
and the vent assembly 574 can be conveniently stowed with the
cavities formed in face 628c with the delivery line neatly wrapped
around the unit and securely stowed within channel 577. At time of
use, the components can be quickly and easily removed from their
respective storage cavities and the delivery line expeditiously
unwound from the unit. Upon releasing the line clamp 572, and
removal of luer aseptic cap 570b (FIG. 26) the stored energy means
will then cause fluid to flow through the delivery line at a
precisely controlled rate.
[0131] 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.
* * * * *