Fluid dispenser with fill adapter

An elastomeric bladder stored energy type infusion apparatus which includes a unique fill assembly for use in controllably filling the fluid reservoir of the dispenser portion of the apparatus. The filling assembly includes a prefilled vial which is partially received within a novel adapter assembly that functions to operably couple the prefilled vial with the fluid dispenser subassembly of the apparatus. The body of the prefilled vial is surrounded by a protective covering until immediately prior to mating the assembly with the fluid delivery device.

FIELD OF THE INVENTION 
The present invention relates generally to infusion devices. More 
particularly, the invention concerns an elastomeric bladder type infusion 
apparatus which is used for delivering a beneficial agent to a patient at 
a substantially constant rate. The apparatus uniquely includes a fluid 
dispensing assembly and a novel fill assembly which can be interconnected 
with the dispensing assembly for filling the fluid reservoir thereof in 
the field prior to use. 
DISCUSSION OF THE INVENTION 
Many types of infusion pumps embodying an elastomeric balloon or bladder 
for delivery of a quantity of pharmaceutically active material to a 
patient have been suggested in the past. For example, U.S. Pat. No. 
4,915,693 issued to Hessel discloses an infusion pump comprising an 
elastomeric bladder having at least an open end, and an elongate stress 
member extending concentrically within the entire length of the hollow 
portion of the bladder and having a fluid tight seal therewith. Both a 
filling port and an exit port are provided in the stress member, each in 
fluid communication with the interior of the bladder by way of an influent 
and an effluent lumen, respectively. The stress member has a diameter that 
is greater than the relaxed internal diameter of the bladder, and has a 
length that exceeds the relaxed internal length of the hollow portion of 
the bladder, so that it prestresses the bladder in both the axial and 
radial directions when disposed therein, substantially filling the bladder 
in its unfilled state. The Hessel device also includes a one-way valve on 
the stress member which permits flow in the influent lumen only in the 
direction of the interior of the bladder. 
Another type of balloon type infusion device is disclosed in U.S. Pat. No. 
4,386,929 issued to Perry, et al. The Perry, et al. device has spaced 
apart inlet and outlet means and the bladder which is capable of expanding 
and contracting radially and axially upon inflation and deflation. When 
deflated the lumen of the bladder is substantially completely filled by 
lumen filling means which protect the bladder from being punctured by the 
hypodermic needle used to fill and inflate the bladder. The lumen filling 
means resists the compressive load applied during insertion of the needle 
and maintains the inlet and outlet means in spaced apart relationship 
while providing substantially no resistance to the axial expansion of the 
bladder. By having the lumen of the bladder filled with the lumen filling 
means when the bladder is deflated, before its subsequent inflation and 
deflation, substantially complete expulsion of the fluid contents of the 
bladder can be obtained. 
Very early balloon type infusion devices are described in U.S. Pat. Nos. 
3,468,308 and 3,469,578 issued to Bierman. These patents disclose a device 
for expelling a liquid from a bladder member at an extremely slow rate 
over an extended period of time. In the device described in U.S. Pat. No. 
3,469,578, the liquid is expelled solely by pressure induced on the liquid 
by the internal stresses of the distended bladder member. In the device 
disclosed in U.S. Pat. No. 3,468,308, the liquid is expelled by pressure 
control means which controls pressure applied to the exterior of the 
bladder member to control its rate of collapse. 
In the devices described in both of the aforementioned patents, the bladder 
member comprises a balloon, or tube-like member which is typically 
distendable both lengthwise and laterally when initially pressured. 
Admission and discharge of liquid is of necessity, through a single neck, 
or outlet portion of the balloon-like bladder. 
None of the prior art devices known to applicant include the unique fill 
assembly of the present invention which can be used to controllably fill 
the fluid reservoir of the fluid dispenser portion of the invention in the 
field. As will be better understood from the description which follows, 
the fill assembly of the present invention includes a fluid containing 
vial assembly mounted within a unique adapter assembly which functions to 
conveniently mate the vial assembly with the fluid dispenser portion of 
the apparatus to enable expeditious filling of the fluid reservoir 
thereof. Co-pending application, Ser. No. 08/192,031 describes in detail 
the construction of several types of elastomeric bladder stored energy 
type infusion devices of a character similar to the fluid dispenser 
portion of the apparatus described herein. The apparatus of the present 
invention comprises an improvement of these devices and accordingly 
application, Ser. No. 08/192,031, is hereby incorporated by reference in 
its entirety as though fully set forth herein. 
SUMMARY OF THE INVENTION 
It is an object of the present invention to provide an elastomeric bladder 
stored energy type infusion apparatus which includes a unique fill 
assembly for use in controllably filling the fluid reservoir of the 
dispenser portion of the apparatus. 
Another object of the present invention is to provide an apparatus of the 
aforementioned character in which the fill assembly comprises a vial 
assembly of generally conventional construction that can be prefilled with 
a wide variety of medicinal fluids. 
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 a novel adapter assembly that 
functions to operably couple the vial assembly with the fluid dispenser 
subassembly of the apparatus. 
Another object of the invention is to provide an adapter assembly of the 
type described in which the body of the prefilled vial is surrounded by a 
protective covering until immediately prior to mating the assembly with 
the fluid delivery device. 
Another object of the invention is to provide an apparatus as described in 
the preceding paragraphs in which the adapter assembly includes locking 
means for locking the assembly to the fluid delivery assembly following 
filling of the fluid reservoir thereof. 
Another object of the invention is to provide a novel adapter assembly for 
use with the bladder type stored energy fluid dispenser subassembly of the 
apparatus which is easy to use, is inexpensive to manufacture, and one 
which maintains the prefilled vial in an aseptic condition until time of 
use. 
Other objects of the invention are set forth in Ser. No. 08/192,031 which 
is incorporated herein by reference and in Ser. No. 08/053,723 which is, 
in turn, incorporated by reference in U.S. Ser. No. 08/192,031.

DESCRIPTION OF ONE FORM OF THE INVENTION 
Referring to the drawings and particularly to FIGS. 1 through 9, one form 
of the fluid dispenser apparatus of the present invention is there 
illustrated and generally identified by a numeral 10. Apparatus 10 
comprises two main assemblies, namely a fluid dispensing assembly 11 and a 
fill assembly 12 for use in filling the fluid reservoir of the dispensing 
assembly. Dispensing assembly 11, the details of construction of which 
will presently be described, is similar in many respects to the dispenser 
described in Ser. No. 08/192,031 and includes a tubular support, a stored 
energy means for forming in conjunction with the support a fluid reservoir 
for containing medicinal fluids to be controllably infused into a patient 
and a generally cylindrically shaped housing which circumscribes the 
tubular support and stored energy means. 
As best seen by referring to FIGS. 2 and 6, the fill assembly portion 12 of 
the apparatus comprises a container subassembly 14, an adapter subassembly 
15, and a cover subassembly 17, the character of which will presently be 
described. Container subassembly 14 includes a body portion 16, having a 
fluid chamber 18 for containing an injectable fluid "F" provided with 
first and second open ends 20 and 22 (FIGS. 7 and 8). First open end 20 is 
sealably closed by closure means here provided in the form of a pierceable 
septum assembly 24. Septum assemby 24 is held securely in position by 
clamping ring 24a. As best seen in FIGS. 7 and 8, a plunger 26 is 
telescopically movable within chamber 18 of container subassembly 14 from 
a first location shown in FIG. 7 where it is proximate first open end 22 
to a second position shown in FIG. 8 where it is proximate first open end 
20. The vial portion of the container subassembly 14 can be constructed of 
various materials such as glass and plastic. 
Referring particularly to FIG. 6, it can be seen that the adapter 
subassembly 15 comprises a hollow housing 30 having a first open end 32 
and a second closed end 34 (FIG. 8). Container subassembly 14 is 
telescopically receivable within open end 32 of housing 30 in the manner 
shown in FIG. 7 so that the housing can be moved from the first extended 
position shown in FIG. 7 to the vial encapsulation position shown in FIG. 
8. Forming an important part of the adapter subassembly is pusher means 
shown here as an elongated pusher rod 36 which functions to move plunger 
26 within fluid chamber 18 from the first position shown in FIG. 7 to the 
second position shown in FIG. 8. In the form of the invention shown in the 
drawings, pusher rod 36 has a first end 36a interconnected with closure 
wall 34 and an opposite end 36b which engages plunger 26 and causes 
telescopic movement of the plunger within chamber 18 of container 
subassembly 14 as housing 30 is moved from the extended position into the 
vial encapsulating position shown in FIG. 8. 
As best seen by referring to FIG. 9, the interior wall 31 of housing 30 is 
provided with circumferentially spaced-apart protuberances 40 which engage 
and center container subassembly 14 within housing 30. Due to the small 
surface area presented by protuberances 40, there is little frictional 
resistance to the sliding movement of container subassembly 14 relative to 
housing 30 as the housing is moved from the extended position shown in 
FIG. 7 into the vial encapsulating position shown in FIG. 8. 
Referring to FIG. 6, it is to be noted that cover subassembly 17 of the 
fill assembly of the present form of the invention includes a spiral 
wound, frangible portion 42 having a first open end 44 for telescopically 
receiving body portion 16 of container subassembly 14 (FIG. 7) and a 
second closed end 46. Portion 42 initially circumscribes a major portion 
of container subassembly 14 in the manner best seen in FIG. 7. An integral 
pull tab 42a is provided to permit the spiral wound, frangible portion to 
be pulled from container subassembly 14 so as to expose a substantial 
portion of body 16. As best seen in FIG. 6, a medicament label 50 
circumscribes spiral wound portion 42 and serves to prevent accidental 
unwinding of the spiral portion from the container subassembly 14. 
However, upon pulling tab 42a, the spiral portion will unwind and, in so 
doing, will tear medicament label 50 so that the spiral portion 42 of the 
covering as well as the cylindrical portion 52 which, also comprises a 
part of the cover assembly, can be slipped from the container 14 so as to 
expose to view septum assembly 24. 
As shown in FIGS. 6 and 7, apertured end 52a of cylindrical portion 52 of 
subassembly 17 is provided with venting apertures 54 which are covered by 
a porous vent patch 56 which can be constructed from any suitable porous 
material that will permit air entrapped within the interior of subassembly 
cover subassembly 17 to be expelled to atmosphere as the subassembly is 
placed over container subassembly 14. 
Turning once again to FIGS. 2 through 5, the fluid dispensing assembly 11 
of the apparatus of the invention can be seen to comprise an elongated 
housing 60 having an internal chamber 62 and a support 64 disposed within 
internal chamber 62 and extending longitudinally thereof. The stored 
energy means of the invention is here provided in the form of a generally 
cylindrically shaped, elongated elastomeric member 66. Housing 60 includes 
a generally cylindrically shaped central portion 60a and inlet and outlet 
end plates 60b and 60c respectively. Central section 60a and end plates 
60b and 60c may be constructed from any suitable rigid plastic material 
such as a polycarbonate and the end plates can be affixed to the central 
section by any suitable means such as adhesive bonding or an appropriate 
sonic weldment. Elastomeric member 66 is securely affixed proximate its 
ends to a two-part support 64 (FIG. 4) by means of suitable ring clamps 68 
and 70 such as self-locking plastic panduit strips of the character shown 
in FIG. 2. 
As best seen by referring to FIG. 4, support 64 is provided with an 
elongated receiving chamber 82 having an inner end wall portion 84 with 
supports a hollow piercing cannula 86 which extends into receiving chamber 
82. Wall 84 is provided with first and second radially extending fluid 
passageways 90 and 92. Passageway 90 communicates proximate its central 
portion with the fluid passageway of hollow cannula 86 and communicates at 
its extremities with a fluid reservoir 94 formed between elastomeric 
member 66 and the outer central surface of support 64. The extremities of 
passageway 92 also communicate with fluid reservoir 94, while the center 
of the passageway communicates with a longitudinally extending outlet 
passageway 96, which, in turn, communicates with flow control means 97, 
the character of which will presently be described. End plate 60c is 
provided with an outlet passageway 100 which is in communication with the 
flow control means 97 and forms a part of luer connector like construction 
102 which is integrally formed with end plate 60c. 
The novel flow control means of the form of the invention shown in FIG. 4 
comprises an assemblage made up of three disc-like wafers which are 
mounted proximate the ends of a rate control chamber 104 formed in a 
cylindrical extension 105 of the end plate 60c. Wafers 106 and 108 of the 
assemblage comprise porous glass distribution frits of a character well 
known in the art, while intermediate wafer 110 comprises a filter member. 
A rate control assemblage, generally designated by the numeral 112, is 
disposed between glass frit 106 and filter member 110. 
Filter member 110 can be constructed from a wide variety of materials, but 
a material comprising polysulfone sold by Gelman Sciences under the name 
and style of SUPOR has proven satisfactory for the purpose. Rate control 
assemblage 112 is preferably constructed from a porous material having 
small flow apertures which controllably impede fluid flow. However, a 
number of other materials can also be used to construct this permeable 
member including metals, ceramics, cermet, plastics and glass. The rate 
control member can be specifically tailored to accommodate very specific 
very specific delivery regimes including very low flow and intermediate 
flow conditions. Such rate control assemblages are well known by those 
skilled in the art. 
In using the apparatus of the invention, with the fill assembly in the 
filled configuration shown in FIG. 7, the cover subassembly is first 
removed from the container subassembly by pulling on pull-tab 42a. This 
will cause the spiral portion 42 of the cover subassembly to tear away 
from the container subassembly so that it can be separated from the 
forwardly disposed portion 52. Once the spiral wound portion 42 is 
removed, cylindrical portion 52 can also be removed and discarded. Removal 
of the cover subassembly exposes the forward portion of the container 
subassembly and readies the adapter subassembly for interconnection with 
the fluid dispensing assembly 11. 
Mating of the adapter subassembly 15 with the dispensing assembly 11 is 
accomplished by telescopically inserting the exposed container portion of 
the container subassembly 14 into receiving chamber 82 and pushing the 
assemblage forwardly of housing 60. As the adapter subassembly approaches 
a seated position within receiving chamber 82, the piercing cannula 86 
connected to end portion 64 will pierce septum assembly 24 of the 
container subassembly. Once the fluid flow path between the hollow cannula 
and the fluid reservoir 94 of the fluid dispensing device is thus created 
via passageway 90, a continued inward movement of the adapter subassembly 
15 will cause pusher rod 36 thereof to move plunger 26 forwardly of 
chamber 18 to a position shown in FIG. 4. As plunger 26 is moved forwardly 
of chamber 18, fluid contained within the chamber will flow through the 
hollow cannula into passageway 90 of partition wall 84 and then into fluid 
reservoir 94. As the fluid under pressure flows into reservoir 82, 
membrane 66 will be distended outwardly in the manner shown in FIG. 4 
wherein the central portion thereof is spaced from support 64. Rings 68 
and 70, which are in clamping engagement with support 64 function to seal 
the membrane against the end portions of the support and prevent leakage 
of fluid between the membrane and the support. As the distendable membrane 
expands outwardly, the displaced air within housing 60 will be vented to 
atmosphere via vent means "V" provided in end plate 60b. 
It is to be understood that membrane 66 can comprise a single film layer or 
can be made up of a laminate construction comprising of a number of 
cooperating layers of material. Materials suitable for constructing 
membrane 66 include latex rubber, polyisoprene (natural rubber), butyl 
rubber, nitrile rubber, other homopolymer, copolymers (random, 
alternating, block, graft, crosslink and starblock), mechanical poly 
blends and interpenetrating polymer networks. 
Once distendable membrane 66 is distended to form fluid reservoir 94, the 
apparatus will remain in this filled condition until outlet passageway 100 
of the luer like connector assembly 102 is opened by the removal of a 
suitable closure cap 103 of the character shown by the phantom lines in 
FIG. 4. With outlet passageway 100 opened, the stored energy means or 
membrane 66 will tend to return to a less distended condition causing 
fluid to flow outwardly of the apparatus via passageway 92, passageway 96, 
through the flow control means 97, and then through passageway 100. 
Materials suitable for use in constructing housing 60 and support 64 
include metals, rubber or plastics that are compatible with the liquids 
they contact and are preferably non-allergenic type material. Examples of 
such materials are: stainless steel, aluminum, latex rubber, butyl rubber, 
nitrile rubber, polyisiprene, styrene-butadiene copolymer, silicones, 
polyolefins such as polypropylene and polyethylene, polyesters, 
polyurethane, polyamides and polycarbonates. Manufactures of suitable 
materials for use in constructing the fluid dispensing assembly of the 
invention include: Dow Corning of Midland, Mich.; General Electric of 
Schenectady, N.Y.; and Shell Chemical Company of Houston, Tex.; DuPont 
Chemical of Wilmington, Del.; and Eastman Chemical of Kingsport, Tenn. 
In order to securely lock the adapter subassembly with the dispensing 
assembly 11 after the reservoir has been filled, novel locking means are 
provided. The locking means here comprise a series of locking teeth 122 
and 124 respectively. As indicated in FIG. 4, these locking teeth are 
constructed so that they will slide under a flexible locking tab 126, 
which is provided proximate the entrance of receiving chamber 82, as the 
adapter subassembly is urged inwardly of receiving chamber 82. However, 
once the adapter subassembly has reached the fully forward position shown 
in FIG. 4, locking tab 126 will engage one of the teeth 124 and 
effectively prevent removal of housing 60 of the adapter subassembly from 
passageway 82. With this novel construction, once the reservoir 94 has 
been filled with the fluid "F" contained in the container subassembly, the 
adapter assembly cannot be removed from the fluid dispensing device and, 
thereby preventing system adulteration. 
Turning to FIG. 10 another form of the apparatus of the invention is there 
shown. This apparatus is similar in construction and operation to that 
shown in FIG. 1 through 9 save that the septum of container septum 
assembly, designated in FIG. 10 as 25, is a slit septum and the cannula, 
designated in FIG. 10 as 86a, is a blunt cannula configuration. Such 
constructions are well known to those skilled in the art and can be used 
in lieu of conventional non-coring pierceable septums and sharp needles. 
The blunt cannula type device partially shown in FIG. 10 operates in the 
same manner as the apparatus of FIGS. 1 through 9. 
Referring next to FIGS. 11 through 15, still another embodiment of the 
present invention is there illustrated. This embodiment is also similar in 
many respects to the embodiment shown in FIGS. 1 through 9 and, 
accordingly, like numbers have been used to identify like components. The 
primary difference between this latest form of the invention and that 
previously described herein is the provision of an alternate fill means 
for filling the reservoir of the device. Forming a part of this novel 
alternate fill means are strategically located valve means which are 
disposed within the dispensing assembly for controlling fluid flow through 
the apparatus. As will become apparent from the discussion that follows, 
this novel valve means permits the inclusion of a fill line 211, which 
forms a part of the alternate fill means, and a fluid delivery line each 
of which communicates with the reservoir of the device. 
Considering particularly FIGS. 11 and 15, the fluid dispensing assembly of 
this latest form of the invention can be seen to comprise an elongated 
housing 60 having an internal chamber 62 and a two-part support 154 
disposed within internal chamber 62 and extending longitudinally thereof. 
The stored energy means of the invention is here provided in the form of a 
generally cylindrically shaped, elongated elastomeric member 66 of 
identical construction to that previously described. 
Housing 60 comprises a cylindrically shaped central portion 60a and inlet 
and outlet end plates 60b and 156 respectively. Central section 60a and 
end plates 60b and 156 may be constructed from any suitable rigid plastic 
material such as a polycarbonate and the end plates can be affixed to the 
central section by any suitable means such as adhesive bonding or an 
appropriate sonic weldment. As before, end plate 60b is provided with a 
vent port "V" for venting gases within the housing to atmosphere. 
Elastomeric member 66 is securely affixed proximate its ends to support 
154 by means of suitable ring clamps 68 and 70 such as self-locking 
plastic panduit strips. 
As best seen by referring to FIG. 15, support 154 is formed by a forward 
section 154a and a rearward section 154b which is integrally formed with 
end plate 60b. Support 154 is provided with an elongated receiving chamber 
157 having an inner end wall portion 158 which is provided with a central 
counterbore 160 (FIG. 11). Wall 158 is also provided with first and second 
radially extending fluid passageways 162 and 164. Passageway 162 
communicates proximate its central portion with counterbore 160 and 
communicates at its end portions with a fluid reservoir 167 (FIG. 15) 
formed between elastomeric member 66 and the outer central surface of 
support 154. The extremities of passageway 164 communicate with fluid 
reservoir 167 while the center portion thereof communicates with an inlet 
passageway 168, which, in turn, communicates with a central bore 170 
provided in end plate 156. End plate 156 is also provided with an inlet 
passageway 172 which forms a part of a luer like connector 174 which is 
integrally formed with end plate 156. 
As shown in FIG. 15, end wall or partition 158 of support 154 is also 
provided with a pair of radially spaced, longitudinally extending fluid 
passageways 176 and 178. The inboard end of each of these passageways 
communicates with reservoir 167 while the outboard ends thereof 
communicate with novel flow control means for controlling fluid flow 
outwardly of passageways 176. This flow control means here comprises an 
annular shaped filter 180 and an annular shaped rate control member 182. 
Member 182 overlays a generally annular shaped chamber 187 formed in end 
plate 156, which chamber, in a manner presently to be described, 
communicates with the fluid outlet port of the apparatus via bore 191. As 
best seen in FIG. 13, annular chamber 187 includes a multiplicity of 
microchannels and grooves 187a which direct the flow of fluid toward an 
outlet passageway 186 formed in end plate 156 (see also FIG. 11). Outlet 
passageway 186 communicates with a fluid delivery tube 190 one end of 
which is received within a bore 191 formed in end plate 156. The opposite 
end of tube 190 is connected to a conventional luer fitting 192. A female 
luer cap 192a (FIG. 15) is mateable with fitting 192 to block fluid flow 
outwardly of delivery tube 190. 
Forming an important aspect of this latest form of the dispensing device is 
the provision of a first check valve means for controlling fluid flow 
toward inlet passageway 162. This first valve means is here provided in 
the form of a first valve assembly which includes a valve seat defining 
housing 195 which has an internal valve seat 197 and an outwardly 
extending hollow piercing cannula 199 (FIG. 11). Housing 195, which is 
closely receivable within counterbore 160 formed in wall 158, houses a 
generally spherical shaped rubber or silicone valve member 201 which is 
normally held in sealing engagement with a seat 197 formed in housing 195 
by a biasing means shown here as a coil spring 204. 
A second check valve means controls fluid flow between passageway 172 and 
passageway 168. This second valve means which forms a part of the 
alternate fill means, comprises a valve member 200 which includes a body 
portion 200a, a neck portion 200b and an intermediate tapered shoulder 
200c. Check valve member 200 can be constructed from rubber, silicone, 
urethane and like materials. When reservoir 167 is filled, fluid under 
pressure within passageway 168 will maintain shoulder 200c of the valve 
member in sealing engagement with the valve seat 207 formed in end plate 
156. 
When the alternate fill means is used to fill reservoir 167 of the 
dispensing portion of the apparatus, a filling line assembly 210, which 
includes a fill line 211, is connected to luer like connector 174 so that 
fluid under pressure can be introduced into passageway 172. This fluid 
under pressure will move valve 200 member inwardly causing shoulder 200c 
to move away from seat 207 thereby permitting fluid to flow past valve 
member body 200a, through a plurality of circumferentially spaced channels 
209 formed in end plate 156 (see FIGS. 11 and 13). Fluid will then flow 
into inlet passageway 168 to passageway 164 to either fill or partially 
fill the reservoir 167. By way of example a dilluent could be introduced 
into reservoir 167 via the filling line assembly 210 and an injectable 
drug could be introduced into the reservoir using fill assembly 12. 
When it is desired to fill or partially fill reservoir 167 with the fill 
assembly of the invention, the cover subassembly is, as before, removed 
from the container subassembly by pulling on pull-tab 42a and the adapter 
subassembly is then telescopically inserted into receiving chamber 157 in 
the manner shown in FIG. 15. 
As the adapter subassembly approaches a seated position within the 
receiving chamber 157, the piercing cannula 199 will pierce septum 24 of 
the container subassembly. Once a fluid flow path between the hollow 
cannula and the fluid reservoir 167 of the fluid dispensing device is thus 
created, a continued inward movement of the adapter subassembly 15 will 
cause pusher rod 36 thereof to move plunger 26 forwardly of chamber 18 to 
a position shown in FIG. 15. As plunger 26 is moved forwardly of chamber 
18, fluid contained within the chamber will flow through the hollow 
cannula and will move valve element 201 away from seat 197 against the 
urging of spring 204. With the valve means open, the fluid will flow into 
passageway 162 of partition wall 158 and then into fluid reservoir 167. As 
the fluid under pressure flows into reservoir 167, membrane 66 will be 
distended outwardly in the manner shown in FIG. 15 wherein the central 
portion thereof is spaced from support 154. It is to be noted that at the 
commencement of the fluid delivery step, spring 204 will urge valve 
element 201 into sealing engagement with seat 197 thereby maintaining 
reservoir 167 in a filled condition. 
As before, locking means, including a flexible locking tab 154c, is 
provided on support 154 to engage locking teeth 122 and 124 provided on 
adapter 15 in order to lock the adapter in position within housing 150 
after the filling step has been completed. A medicament label "L" 
surrounds housing 150 to identify the medicament contained within the 
reservoir 167. 
Once distendable membrane 66 is distended to form fluid reservoir 167, the 
apparatus will remain in this filled condition until the outlet passageway 
of the fitting 192 is opened by the removal of female luer 192a (FIG. 15). 
With the outlet passageway thus opened, the stored energy means or 
membrane 66 will tend to return to a less distended condition causing 
fluid to flow outwardly of the apparatus via passageway 176 and 178, 
through the flow control means 97, into annular chamber 187, and then 
outwardly through passageway 186 and into delivery tube 190. 
Turning now to FIGS. 16 through 22, yet another embodiment of the present 
invention is there illustrated. This embodiment is similar in many 
respects to the embodiment shown in. FIGS. 1 through 9 and, accordingly 
like numbers have been used to identify like components. The primary 
difference between this last form of the invention and that of FIGS. 1 
through 9 is the design of the outlet, or forward portion of the 
dispensing assembly. More particularly, as best seen in FIG. 21, this form 
of the invention includes alternate fill means for filling the fluid 
reservoir of the device. This alternate fill means includes a radially 
offset inlet, part of which includes check valve means for controlling 
fluid flow toward the reservoir 94 of the device. This check valve means 
is housed within a chamber 248 formed in the inboard end of a luer like 
connector 250 which is connected to an end plate 252 and comprises a valve 
member 254 having a body portion 254a, a neck portion 254b and an 
intermediate shoulder portion 254c. Chamber 248 communicates via 
passageway 255a of manifold element 255 (FIGS. 16 and 21) with an inlet 
passageway 256 which is formed in end wall 260a of support 260 and which, 
in turn, communicates with reservoir 94 via annular passageway 256a. 
Central support 160, which is virtually identical to support 64 of the 
embodiment shown in FIG. 4, is also provided with an end wall portion 260a 
having formed thereon radially extending passageways 90 and 92 each of 
which communicates with reservoir 94. As before, the central portion of 
passageway 92 communicates with a passageway 96, which, in turn, 
communicates with the flow control means of the invention. As best seen in 
FIG. 21, an outlet passageway 263 interconnects the flow control means 
with an outlet luer like connector 265 which forms an integral part of end 
plate 252. Connector 265 is designed to receive a closure cap 267 which 
functions to block fluid flow through passageway 263. Similarly, inlet 
luer connector 250 is designed to lockably mate with a locking fill cap 
270. Cap 270 includes circumferentially spaced locking fins 270a which 
lockably mate with circumferentially spaced fins 270e provided on fitting 
250 (FIGS. 16, 17, and 21). With this arrangement, once cap 270 is 
connected to fitting 250, it will be securely locked in place thereon and 
sealably close the inlet passageway thereof. 
As best seen in FIG. 16, the flow control means of the present form of the 
invention comprises an assemblage made up of four disc-like wafers which 
are mounted within a rate control chamber 271 formed in end wall 260 of 
central support 260. Wafers 272 and 274 of the assemblage comprise porous 
glass distribution frits while intermediate wafer 276 comprises a filter 
member and intermediate wafer 278 comprises a rate control member. 
Filter member 276 can be constructed from a wide variety of materials, but 
a material comprising polysulfone sold by Gelman Sciences under the name 
and style of SUPOR has proven satisfactory for the purpose. Rate control 
member 278 is preferably constructed from a thin film, polycarbonate 
material having extremely small flow apertures ablatively drilled by an 
excimer laser ablation process. Both the orifice size and unit 
distribution can be closely controlled by this process. However, a number 
of other materials can also be used to construct this permeable member 
including metals, ceramics, plastics and glass. The rate control C member 
can be specifically tailored to accommodate various delivery regimens 
including low flow and intermediate flow conditions. 
The apparatus of this last form of the invention, is used in the same 
general manner as previously described to fill reservoir 94 either by 
means of the fill assembly or by means of the fill port or luer like 
fitting 250. When filling is accomplished using the alternate fill means, 
fluid is introduced into passageway 256 by exertion of fluid pressure on 
valve member 254 sufficient to move shoulder 254c away from seat 250a of 
fitting 250 so that fluid can flow past valve member body 254a, passageway 
255a of manifold element 255, and through a plurality of circumferentially 
spaced channels 280 formed in fitting 250 through chamber 248, into 
passageway 255a of manifold 255 and then into passageway 256 (FIG. 19). In 
this instance filling of the reservoir is accomplished by a separate luer 
type fill fitting (not shown) and a separate fill line (not shown). After 
the reservoir is filled, the separate fill fitting is removed and replaced 
by a sealing closure 270 (FIG. 21). Cap 270 includes circumferentially 
spaced locking fins 270a which lockably mate with circumferentially spaced 
fins 270-l provided on fitting 250. With this arrangement, once cap 270 is 
connected to fitting 250, it will be securely locked in place thereon. 
When it is desired to fill or partially fill reservoir 94 using the fill 
assembly rather than the alternate fill means, the fill assembly is mated 
with the fluid delivery assembly in the same manner as previously 
described, herein in connection with the embodiments of FIGS. 1 through 
15. 
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.