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.

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&#39;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]    [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]    [0030]FIG. 2 is a side-elevational, cross-sectional, exploded view of the vial assembly shown in FIG. 1.  
         [0031]    [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]    [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]    [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]    [0034]FIG. 5 is a cross-sectional view taken along lines  5 - 5  of FIG. 3.  
         [0035]    [0035]FIG. 5A is a fragmentary, cross-sectional view of the area designated as  5 A in FIG. 5.  
         [0036]    [0036]FIG. 6 is a fragmentary, cross-sectional view similar to FIG. 5, but showing an alternate form of membrane capture means.  
         [0037]    [0037]FIG. 7 is a side-elevational view of an alternate form of reservoir fill assembly.  
         [0038]    [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]    [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]    [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]    [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]    [0042]FIG. 12 is a generally perspective, exploded view of one form of the flow control and flow indicator means of the invention.  
         [0043]    [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]    [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]    [0045]FIG. 13B is a fragmentary, generally perspective view illustrating an alternate form of flow control means of the invention.  
         [0046]    [0046]FIG. 13C is a fragmentary, generally perspective view illustrating yet another form of flow control means of the invention.  
         [0047]    [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]    [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]    [0049]FIG. 16 is an enlarged, cross-sectional view taken along lines  16 - 16  of FIG. 15.  
         [0050]    [0050]FIG. 17 is a generally perspective bottom view of an alternate form of the fluid delivery apparatus of the invention.  
         [0051]    [0051]FIG. 18 is a generally perspective, top view of the apparatus shown in FIG. 17.  
         [0052]    [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]    [0053]FIG. 20 is a front view of the apparatus showing the closure means of the invention in an open configuration.  
         [0054]    [0054]FIG. 21 is a cross-sectional view taken along lines  21 - 21  of FIG. 20.  
         [0055]    [0055]FIG. 22 is a cross-sectional view taken along lines  22 - 22  of FIG. 20.  
         [0056]    [0056]FIG. 23 is an enlarged, exploded, cross-sectional view of the fluid flow control means of this latest form of the invention.  
         [0057]    [0057]FIG. 24 is a view of the flow control means of FIG. 23 shown in assembled configuration.  
         [0058]    [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]    [0059]FIG. 26 is an exploded, generally perspective, rear view of the apparatus shown in FIG. 25.  
         [0060]    [0060]FIG. 27 is a generally perspective, bottom view of another form of the apparatus of the invention.  
         [0061]    [0061]FIG. 28 is a generally perspective top view of the apparatus shown in FIG. 27.  
         [0062]    [0062]FIG. 29 is a front view of the fluid dispensing apparatus shown in FIG. 28.  
         [0063]    [0063]FIG. 30 is a cross-sectional view taken along lines  30 - 30  of FIG. 29.  
         [0064]    [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]    [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  150   a , a flow rate control subassembly  150   b , a flow indicator subassembly  150   c  and a fill assembly  150   d.  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  150   d.  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  150   d  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  184   a.  Septum  184   a  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  196   a  interconnected with closure wall  194  and an opposite end  196   b  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  3   a , 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  200   a  is provided to permit the tear-off cover  200   b  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  200   c  (FIG. 3A) which lockably engages saw tooth-like protuberances  190   a  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  165   a  formed in the end wall of receiving chamber  165  and is held in position therewithin by a cylindrically shaped housing  185   a  having an end wall  185   b  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  209   a  which will deform inwardly within cavity  165   a  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  158   a  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  154   a  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®. 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  158   a  as it tends to return toward its original configuration. As the membrane moves toward protuberance  158   a , 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  160   a  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  160   a  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  153   a  which tongues are closely receivable within a pair of grooves  161   a  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  161   a  by tongues  153   a.  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  230   a  of slightly different construction, which is closely received within a circular recess  232  formed in support structure  234  (see FIG. 12). Rate control membrane  230   a  comprises a very thin (approximately 0.018 inch thick), rigid polyester plate having only a single small laser drilled orifice  236   a.  This rate control membrane  230   a  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  230   a  and functions to filter particulates from the fluids flowing from passageway  262  toward rate control membrane  230   a  (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  230   a  which is also closely received within a circular recess form in support structure  234  (see FIG. 13). Rate control frit  230   b  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  287   a.  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  230   b  and, as before, functions to filter particulates from the fluids flowing from passageway  262  toward rate control frit  230   b  (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  266   a  which is circumscribed by a marginal portion  266   b.  Marginal portion  266   b  is clamped between manifold plate  260  and a uniquely configured indicator base  268  so that the boot extends through a generally arcuate-shaped opening  268   a  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  272   a  and an outlet end  272   b.  Insert  271  also has a vertically extending fluid passageway  274  having an upper inlet end  274   a  and a lower outlet end  274   b  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  280   a  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  272   a  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  272   b  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  268   b  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  274   a  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  280   a  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  302   a  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  308   a  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  268   a  and  268   b  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  336   a  which is concentric with the inner wall  336   b  of receiving chamber  336 , forms an integral part of ullage substrate  334  and is radially spaced from the inner wall  336   b  of chamber  336  so as to define a longitudinally extending annular space  336   c.  With this construction, during the mating of the reservoir fill assembly with the reservoir assembly, the outer wall  364   a  of hollow housing  364  is closely receivable within space  336   c  as the adapter subassembly is urged inwardly of chamber  336 . At the same time that wall  364   a  moves forwardly of annular space  336   c , 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  374   a  is provided to permit the cover  374   b  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  374   c  which engages teeth-like protuberances  357  formed on wall  364   a  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  332   a  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  382   a  which will deform inwardly within cavity  332   a  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  402   a  and a fluid outlet  402   b  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  402   a  and outlet  402   b.  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  442   b  of the skirt portion  442   a  thereof is provided with a circumferentially extending bead or protuberance  442   c  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  453   a  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  462   a  and a circumferentially extending bead or protuberance  462   b  surrounding open end  462   a.  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  453   a  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  462   a  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  332   a  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  462   b  formed on second housing  453  will move past protuberance  442   c  formed in skirt  442   a  of the cannula support housing thereby locking second housing  453  against removal from the reservoir assembly. Similarly, tab  374   c  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  336   a  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  336   a.  Each of these ring-shaped guide members  480  includes a plurality of circumferentially spaced, resiliently deformable tabs  480   a  which extend inwardly relative from wall  336   a  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  336   c  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  480   a  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  500   a , a flow rate control subassembly  500   b  (FIG. 24), and a fill assembly  500   c  (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  500   a  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  500   c  which assembly is identical to fill assembly  150   d.  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  508   a  (FIG. 19) as it tends to return toward its original configuration. As the membrane moves toward protuberance  508   a , 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  510   a  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  510   a  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  500   a  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  528   a  and a second, or rearward compartment  528   b.  Rearward compartment  528   b  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  530   a  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  528   a  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  528   a  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  528   a  is formed within an access door  576  which is connected to that portion of the rearward portion of housing  528  which defines rearward compartment  528   b , 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  576   a  which, in cooperation with an interconnected circumscribing wall  576   b , forms forward compartment  528   a  (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  528   a  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  600   a , a flow rate control means  600   b  (FIG. 24) and a fluid delivery means  600   c  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  600   a  of this latest embodiment is virtually identical to reservoir subassembly  500   a  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  600   a  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  628   a  and a second, or rearward compartment  628   b.  Rearward compartment  628   b  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  628   c  of forward compartment  628   a  is formed with a plurality of cavity-like recesses which receive portions of the delivery means. More particularly, face  628   c  has formed therein a cavity  570   a  which closely receives luer assembly  570 , a cavity  572   a  which closely receives clamp  572  and a cavity  574   a  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  628   a  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  628   c  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  570   b  (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.