Abstract:
An elastomeric bladder stored energy type infusion apparatus that can be filled with a medicinal fluid and, after being filled, can efficiently delivery the medicinal fluid to the patient at a selected rate. The apparatus includes a delivery component for delivering medicinal fluid to the patient and a fill component that can expeditiously be used to fill the fluid reservoir of the delivery component in the field.

Description:
BACKGROUND OF THE INVENTION 
     This is a Continuation-In-Part Application of application, Ser. No. 09/250,036 filed Feb. 12, 1999, now U.S. Pat. No. 6,086,561 which is a Continuation-In-Part of Ser. No. 09/017,047 filed Feb. 2, 1998 which has now issued into U.S. Pat. No. 5,962,794, which is a Continuation-In-Part of Ser. No. 08/718,686 filed Sep. 24, 1996, now U.S. Pat. No. 5,721,382, which is a Continuation-In-Part of application, Ser. No. 08/432,220, filed May 1, 1995, now abandoned. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to fluid delivery devices. More particularly, the invention concerns an improved apparatus, including a fluid dispenser having visual flow indicator means, for infusing medicinal agents into an ambulatory patient at specific rates over extended periods of time and a novel reservoir fill assembly for controllably filling the reservoir of the fluid dispenser, including a fill assembly for filling the reservoir in the field. 
     DISCUSSION OF THE INVENTION 
     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. 
     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. 
     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. 
     The prior art bladder type infusion devices are not without drawbacks. Generally, because of the very nature of 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. 
     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. 
     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 one of the present inventors. Therefore, U.S. Pat. No. 5,205,820 is hereby incorporated by reference in its entirety as though fully set forth herein. U.S. Pat. No. 5,721,382, also issued to one of the present inventors, describes various alternate constructions and modified physical embodiments of the invention, including the provision of a novel fluid actuated indicator means for visually indicating fluid flow from the device. This latter U.S. Pat. No. 5,721,382 is also hereby incorporated by reference in its entirety as though fully set forth herein. 
     Another somewhat similar apparatus to that of the present invention is described in application Ser. No. 09/250,036 filed by the present inventors on Feb. 12, 1999. Because of the pertinence of this application, U.S. Ser. No. 09/250,036, now U.S. Pat. No. 6,086,561, is hereby incorporated by reference as through fully set forth herein. 
     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 clothing or to the patient&#39;s body and can be used for the continuous infusion of antibiotics, hormones, steroids, blood clotting agents, analgesics including morphine, 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. 
     One form of the apparatus of the present invention uniquely permits the reservoir of the fluid-dispensing component to be filled in the field. 
     Another form of the apparatus of the invention includes novel volume control means for precisely controlling the volume of fluid to be introduced into the reservoir of the dispensing component. 
     SUMMARY OF THE INVENTION 
     It is an object of the present invention to provide an apparatus for delivering fluids at a precisely controlled rate which comprises a fluid dispensing component having a fluid reservoir for containing the fluids to be delivered and a reservoir fill component which can be removably interconnected with the fluid dispensing component. More particularly, it is an object of the invention to provide such an apparatus in which the reservoir fill component can be used in the field to controllably fill the reservoir of the dispensing component and in which the dispensing component can be used for the precise infusion of pharmaceutical fluids to an ambulatory patient at controlled rates. 
     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. 
     A further object of the invention is to provide an accurate and highly reliable fluid delivery device which can be manufactured inexpensively in large volume by automated machinery. 
     Another object of the invention is to provide an apparatus of the type described in the preceding paragraphs which includes novel volume control means for precisely controlling the volume of medicinal fluids that are introduced into the reservoir of the fluid dispensing component. 
     Another object of the invention is to provide an apparatus of the character described that includes first and second reservoir fill assemblies for filling the fluid reservoir of the fluid dispensing component. 
     Another object of the invention is to provide an apparatus of the aforementioned character which includes a delivery component and a filling component which can be operably interconnected with the delivery component to enable expeditious filling in the field of the reservoir of the delivery component. More particularly, the first fill assembly permits the pharmacist to aseptically fill the container under patient-specific-variable volume and concentration of medicament. In this way, body mass index requirements can be met for selected agents as, for example, immuno- and-chemo-therapeutic agents. 
     Another object of the invention is to provide a device of the class described in the preceding paragraphs in which the dispenser component embodies a highly novel fluid flow indicator that provides a readily discernible visual indication of fluid flow status through the device. 
     Another object of the invention is to provide a device of the aforementioned character in which the dispenser component includes a novel infusion means in the form of delivery line assembly, which can be interconnected with the dispenser. 
     Another object of the present invention is to provide a second reservoir fill means in which the container of the fill means is partially received within a novel adapter subassembly that can be sealably connected to an outlet port provided in the base of the fluid dispensing device. 
     Another object of the invention is to provide first and second reservoir fill assemblies for use with the fluid dispenser subassembly of the apparatus which are easy to use, are inexpensive to manufacture, and which maintain the container of the fill assemblies in a substantially aseptic condition until time of use. 
     Other objects of the invention are set forth in U.S. Pat. Nos. 5,205,820 and 5,721,382 and 6,086,561 all of which are incorporated herein by reference. Still further objects will become more apparent from the discussion that follows. 
     By way of summary, the fluid delivery apparatus of the present form of the invention comprises four cooperating components, namely a fluid delivery apparatus or dispenser, an infusion means for infusing medicaments into the patient and first and second reservoir fill assemblies which can be coupled with the fluid dispenser component for filling the fluid reservoir thereof. The fluid dispenser, which readily lends itself to automated manufacture, is generally similar to that described in U.S. Pat. No. 5,721,382 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 dispenser includes a highly novel fluid flow indicator means which is substantially similar to that described in U.S. Pat. No. 6,086,561 and comprises a mechanical fluid flow indicator that provides a clear visual indication of normal fluid flow and absence of fluid flow from the fluid reservoir. One form of the reservoir fill means of the invention also uniquely includes volume control means for controlling the volume of fluid to be introduced into the reservoir of the fluid dispenser by one of the fill means of the invention. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a side-elevational, cross-sectional view of one form of the apparatus of the invention, which includes a fluid delivery component and first and second fill means for filling the reservoir of the fluid delivery component. 
     FIG. 2 is a cross-sectional view taken along lines  2 — 2  of FIG.  1 . 
     FIG. 3 is a fragmentary, top plan view of a portion of the delivery component and of the first fill means of the invention. 
     FIG. 4 is a right-end view of the device shown in FIG.  3 . 
     FIG. 5 is a fragmentary, side-elevational, cross-sectional view of the base of the fluid delivery component of the invention. 
     FIG. 5A is a fragmentary, cross-sectional view of the pusher means of the base component shown in FIG. 5, partly broken away to show internal construction. 
     FIG. 5B is a right-end view of the pusher member shown in FIG.  5 A. 
     FIG. 6 is an enlarged, side-elevational, cross-sectional view of one form of the first fill means of the invention. 
     FIG. 6A is an exploded, cross sectional view of the first fill means shown in FIG.  6 . 
     FIG. 7 is a cross-sectional view similar to FIG. 6, but showing the fluid chamber of the first fill means having been filled using a syringe-type device. 
     FIG. 8 is a fragmentary, cross-sectional view of the right-end portion of the first fill means shown in FIG. 6 illustrating the manner of opening and closing the end panel of the device to enable filling of the fill means in the field. 
     FIG. 9 is a fragmentary, cross-sectional view of an alternate form of first fill means of the invention. 
     FIG. 9A is a fragmentary, cross-sectional, exploded view of the first fill means shown in FIG. 9 illustrating the removal of the end cap thereof to gain access to the fill port of the fill means. 
     FIG. 9B is an exploded, cross-sectional view of a portion of the first fill means shown in FIG.  9 . 
     FIG. 10 is a fragmentary, cross-sectional view of still another form of first fill means of the invention. 
     FIG. 11 is a fragmentary, cross-sectional view similar to FIG. 10, but showing the removal of the end cap of the device to gain access to a slit septum used to fill the fluid chamber of the device. 
     FIG. 12 is a generally perspective view of the form of the first fill means shown in FIG.  6 . 
     FIG. 13 is a generally perspective view of the alternate form of first fill means of the invention shown in FIG.  9 A. 
     FIG. 14 is a generally perspective, exploded view of the first fill means shown in FIG.  10 . 
     FIG. 15 is a generally perspective, exploded view of the fill means shown in FIG.  13 . 
     FIG. 16 is a generally perspective view of one form of the second or adapter fill means of the invention. 
     FIG. 16A is a cross-sectional view of the adapter fill means shown in FIG.  16 . 
     FIG. 17 is a generally perspective, exploded view of one form of the adapter fill assembly shown in FIG.  16 . 
     FIG. 18 is a top plan view of the adapter fill assembly shown in FIGS. 16 and 17. 
     FIG. 19 is a side elevational, cross-sectional view of the adapter fill assembly shown in FIG.  18 . 
     FIG. 20 is a cross-sectional view taken along lines  20 — 20  of FIG.  19 . 
     FIG. 21 is an enlarged cross-sectional view of the area designated in FIG. 20 by the numeral  21 . 
     FIG. 22 is a top plan view of one form of the stop member of the apparatus for controlling the extent of entry of the container assembly into the adapter assembly. 
     FIG. 23 is a side-elevational view of the stop member shown in FIG.  22 . 
     FIG. 24 is a generally perspective view of still another form of adapter fill assembly of the invention. 
     FIG. 24A is a cross-sectional view taken along lines  24 A— 24 A of FIG.  24 . 
     FIG. 25 is a top plan view of the fill assembly shown in FIG.  24 . 
     FIG. 26 is a view taken along lines  26 — 26  of FIG.  25 . 
     FIG. 27 is a cross-sectional view taken along lines  27 — 27  of FIG.  26 . 
     FIG. 28 is an enlarged cross-sectional view taken along lines  28 — 28  of FIG.  26 . 
     FIG. 29 is a cross-sectional view taken along lines  29 — 29  of FIG.  26 . 
     FIG. 30 is a generally perspective top view of the indicator housing of the fill assembly shown in FIG.  24 . 
     FIG. 31 is a generally perspective bottom view of the indicator housing shown in FIG.  30 . 
     FIG. 32 is a generally perspective, exploded view of the adapter fill assembly shown in FIG.  24 . 
     FIG. 33 is an enlarged, fragmentary, cross-sectional view of the control portion of the fill assembly for controlling the positioning of the stop member of the container assembly. 
     FIG. 34 is a cross-sectional view similar to FIG. 33, but showing the locking means of the assembly in a locked position locking the stop member of the fill adapter in a fixed position. 
     FIG. 35 is a generally perspective view of still another form of adapter fill assembly of the present invention. 
     FIG. 36 is a generally perspective, exploded view of the fill assembly shown in FIG.  35 . 
     FIG. 37 is a top plan view of the adapter fill assembly shown in FIG.  35 . 
     FIG. 38 is a view taken along lines  38 — 38  of FIG.  37 . 
     FIG. 39 is a cross-sectional view taken along lines  39 — 39  of FIG.  38 . 
     FIG. 40 is a cross-sectional view taken along lines  40 — 40  of FIG.  38 . 
     FIG. 41 is an enlarged cross-sectional view taken along lines  41 — 41  of FIG.  38 . 
     FIG. 42 is a generally perspective top view of the indicator housing of the form of the invention shown in FIG.  35 . 
     FIG. 43 is a generally perspective bottom view of the indicator housing shown in FIG.  42 . 
     FIG. 44 is a generally perspective view of one form of the locking means of this latest form of the invention. 
     FIG. 45 is an enlarged, fragmentary, cross-sectional view of the locking means portion of the fill adapter shown in FIG.  35 . 
     FIG. 46 is a fragmentary, cross-sectional view similar to FIG. 45, but showing the locking member in a locked position. 
    
    
     DESCRIPTION OF THE INVENTION 
     Referring to the drawings and particularly to FIGS. 1 through 5, one form of the apparatus of the invention for controlled delivery of medicinal fluid to a patient is there shown and generally designated by the numeral  20 . The apparatus here comprises four major components, namely a fluid delivery component  22 , first and second fill assemblies  24  and  26  respectively and infusion means for infusing medicinal fluids into the patient. The construction of the first and second fill assemblies  24  and  26  will be described hereinafter. 
     The fluid delivery component  22  includes a housing  30  having a base assembly  32  and a stored energy means which cooperates with the base assembly to form a fluid reservoir  34  (FIG.  1 ). Reservoir  34  is provided with first and second inlets  38  and  40  respectively. Base assembly  32  also includes a base  42  having a receiving chamber  44  formed therein (FIG.  5 ). The stored energy means of this form of the invention comprises an elastomeric membrane  46  which is clamped to base  42  by means of a clamping ring  48  in a manner similar to that described in incorporated by reference U.S. Pat. No. 5,840,071. Clamping ring  48 , along with elastomeric membrane  46  is enclosed by a cover  50  of the configuration shown in FIGS. 1 and 2. As best seen in FIG. 1, receiving chamber  44  of base  42  is adapted to controllably receive the first fill means or assembly  24  of the invention to permit controlled filling of the reservoir of the device via inlet  40 . Base  42  also includes a fill port assembly  52  to which the second fill means or assembly  26  of the invention can be removably interconnected. As indicated in FIG. 1, fill port assembly  52  communicates with inlet  38  via a fluid passageway  39 . The construction and operation of the important fill port assembly  52  will presently be described. 
     Turning particularly to FIGS. 6,  6 A,  7 ,  8  and  12 , one form of the first fill assembly  24  of the invention can be seen to comprise a container subassembly  60  that includes a container, or vial portion  60   a  having a fluid chamber  62  for containing an injectable fluid “F”. As shown in FIG. 12, container subassembly  60  can be provided with a medicament identification label  63 . Fluid chamber  62  is provided with first and second open ends  62   a  and  62   b . First end  62   a  is closed by an apertured, self-venting peel away aseptic cover  64 . Second open end  62   b  is sealably closed by closure means here provided in the form of a closure subassembly  66 . Displacement means, here shown as a plunger  68  is telescopically movable within chamber  62  of container subassembly  60  in the manner indicated in FIGS. 6 and 7. 
     In the manner shown in FIGS. 6,  7 , and  8  closure subassembly  66  is sealably connected to container  60   a  and to a conically shaped connector member  67 , which has a fluid passageway  67   a . Closure assembly  66  comprises a generally cylindrically shaped closure housing  70  and a closure panel  72  that is hingedly connected to housing  70  by a living hinge  72   a . Panel  72  is movable from the closed position shown in FIG. 6 to the open position in FIG.  7 . Also comprising a part of closure subassembly  66  is connector means for interconnecting fluid chamber  62  of container  60   a  with a source of medicinal fluid. In the form of the invention shown in FIGS. 6 and 7 this connector means comprises a rearwardly extending male luer connector  74 . As shown in FIG. 6, when panel  72  is in the closed position, a sealing protuberance  72   b  formed on end panel  72  will be sealably received within passageway  74   a  of connector  74  to sealably close the passageway. When panel  72  is raised in the manner shown in FIG. 7, connector  74  becomes accessible and can be interconnected with a source of fluid such as a syringe S that includes a female connector S- 1 . As chamber  62  is filled with fluid, plunger  68  will be moved from the first position shown in FIG. 6 to the second position shown in FIG.  7 . Also forming a part of closure subassembly  66  is valve means for controlling fluid flow toward to chamber  62  of container  60   a . In the present form of the invention this valve means comprises a conventional umbrella check valve  76 . 
     Following filling of chamber  62  and removal of peel-away aseptic cover  64 , container subassembly  60  can be telescopically inserted into receiving chamber  44  of base  42  and moved from a first extended position shown in FIG. 1 into a second fluid filling position. Disposed within chamber  44  is a pusher member  80  having the configuration shown in FIGS. 5A and 5B. Pusher member  80  functions to move plunger  68  within the fluid chamber  62  of the container subassembly as the container subassembly is inserted into chamber  44 . During the mating of the first fill means with the fluid delivery component, the outer wall of vial  60   a  is closely received within chamber  44  as the container subassembly is moved inwardly or forwardly of the device housing. It is to be observed that when the container subassembly is originally mated with the delivery component in the manner shown in FIG. 1, threads  69  provided on plunger  68  will mate with internal threads  80   a  provided on pusher member  80  (FIG. 5A) and a pierceable wall  68   a  of plunger  68  of container subassembly  60  will move into piercing engagement with a hollow cannula  84  that is disposed centrally of pusher member  80 . 
     Once the fluid flow path between the hollow cannula  84  and the fluid reservoir  34  of the delivery component  20  is thus created, via a passageway  86  formed in base  42 , via a second check valve  88  mounted within base  42  and a via inlet  40 , the reservoir can be filled as a result of an inward movement of the container subassembly  60  into receiving chamber  44 . As the container subassembly moves inwardly, pusher member  80  will move plunger  68  rearwardly of chamber  62  causing the fluid contained therewithin to be forced outwardly thereof through hollow cannula  84  and into passageway  86 . As the fluid enters inlet  40 , elastomeric member  46  will be distended in the manner shown in FIG. 1 causing the buildup of internal stresses within the member tending to return it to a less distended position. 
     Referring next to FIGS. 9,  9 A,  9 B,  13  and  15 , an alternative form of first fill means of the invention is there illustrated. This form of the invention is similar in many respects to that shown in FIGS. 1 through 8 and previously described herein and like numerals are used in FIGS. 9 and 9A to identify the like components shown in FIGS. 6,  7  and  8 . As illustrated in FIGS. 9 and 9A this alternate form of first fill means of the invention also includes a container  60   a  having a fluid chamber  62 . However, connected to container  60   a  is an alternative form of closure subassembly that is generally designated in FIGS. 9 and 9A by the numeral  89 . Closure subassembly  89  is sealably connected to container  60   a  in the manner shown in FIGS. 9 and 9A and includes an externally threaded closure housing  89   a . Closure housing  89   a  comprises a luer connector member  91  which is of the same general configuration as luer connector member  74 . Closure subassembly  89  further includes an end closure cap  89   b  which is internally threaded so that it can be threadably interconnected with housing  89   a . During the filling step, access to connector  91  is accomplished by threadably removing end cap  89   b  in the manner shown in FIGS. 9A and 15 so as to enable the interconnection therewith of a filling syringe, such as syringe S (FIG.  7 ). 
     Turning to FIG. 10, still another form of first fill means of the invention is there illustrated. This embodiment is similar in many respects to those previously described, and like numerals are used to identify like components. As before, this latest embodiment includes a container  60   a  having a fluid chamber  62 . Connected to container  60   a  in the manner shown in FIG. 10 is a closure subassembly  90 . Subassembly  90  supports check valve  76  in a manner shown in FIG.  10 . As indicated in FIG. 10, in this latest form of the first fill means, subassembly  90  includes a housing  92  and a slit septum  94  which is sealably mounted within a collar  96  which is, in turn, connected to housing  92 . Slit septum  94  is accessible by lifting hingedly mounted end panel  72  in the manner shown by the phantom lines of FIG. 10 so that the septum can be pierced by the cannula of a fill syringe of a character well known to those skilled in the art to effect a controlled filling of chamber  62 . 
     Referring next to FIG. 11, still another form of first fill means of the invention is their illustrated. This form of the invention is similar in many respects to that previously described and like numerals are used in FIG. 11 to identify the like components shown in FIGS.  10 . As illustrated in FIG. 11, this alternate form of first fill means also includes a container  60   a  having a fluid chamber  62 . Connected to container  60   a  is an alternative form of closure subassembly generally designated as  104 . Closure subassembly  104  is connected to container  60   a  in the manner shown in FIG.  11  and includes a closure housing  106 . Connected to closure housing  106  is an externally threaded septum housing  108  within which a slit septum  110  is sealably mounted. Closure housing  106  is connected to a connector member  67  which, in turn, is connected to container  60   a  in the manner shown in FIG.  11 . Adapted to threadably mate with septum housing  108  is an end closure cap  112 . End closure cap  112  is internally threaded so that it can be threadably interconnected with septum housing  108  in the manner indicated in FIG.  11 . During the filling step, access to septum  110  is accomplished by threadably removing end cap  112  so as to enable piercing of slit septum  110  by a cannula of a syringe or like filling component. 
     Once the reservoir has been filled and the container subassembly has been appropriately mated with delivery component  20 , the apparatus will remain in this readied condition until the administration line  115  of the infusion means of the device is opened. Once the administration line has been opened, the stored energy means or membrane  46  will tend to return to a less distended condition causing fluid to flow outwardly of the apparatus via passageway  116 , which is formed in base  42 , via the novel indicator means of the invention (FIG.  1 ). As previously mentioned, the indicator means, which is generally identified in FIG. 1 by the numeral  117 , is of identical construction to that shown and described in incorporated by reference application Ser. No. 09/250,036. Reference to this application should be made for a description of the construction and operation of the indicator means. 
     Considering next the second, or adapter fill assembly  26  of the invention, this assembly is also used to fill reservoir  34  and comprises a novel fluid transport assembly  120  of the general configuration shown in FIGS. 1 and 16. Referring to FIGS. 16,  17 ,  18  and  19 , it is to be noted that fluid transport assembly  120  is specially designed to be mated with fill port assembly  52  formed in base  42  of the fluid dispenser component  20 . As best seen in FIGS. 16 and 16A, fluid transport assembly  120  comprises a fill assembly  26  which is substantially identical to that shown in FIG.  1  and includes an adapter assembly  122  that telescopically accepts a closed end container assembly  123 . 
     Turning to FIGS. 16,  16 A and  19 , it is to be noted that threads  125   a  provided on a plunger  125  of container subassembly  123  of the second fill assembly can be threadably connected to threads  126  provided on a pusher member  128  of adapter assembly  122 . Pusher member  128  also includes a cannula  130  which is constructed and arranged to pierce the central wall  125   b  of plunger  125  when the container subassembly  123  is mated with the adapter assembly  122 . Cannula  130  communicates with fluid chamber of the container  123   a  of container subassembly  123  and here comprises a part of the adapter flow control means of the adapter assembly for controlling fluid flow toward reservoir  34 . 
     As best seen in FIGS. 16,  16 A and  19 , adapter subassembly  122  comprises a hollow container receiving housing  132  having a first open end  132   a  and a second closed end  132   b . Container subassembly  123  of fill assembly  26  is telescopically receivable within open end  132   a  of housing  132  so that container  123   a  thereof can be moved from a first extended position shown in FIG. 16 to a second advanced position wherein container  123   a  is at least partially encapsulated within housing  132 . 
     Also forming a part of the adapter assembly of the invention is a connector means or cap assembly  134  (FIG. 19) which is connected to body portion  132  in the manner shown in FIG.  19 . Cap assembly  134  includes a generally cylindrical exterior wall  136 , the interior surface  136   a  of which forms a chamber  138  into which a cannula  140  extends. To interconnect second fill assembly  120  with the fluid delivery apparatus, the barrel-like portion of closure cap  134  of the second fill assembly is mated with fill port  52  formed in base  42 . As the barrel-like portion enters the lower portion of the fill port, the circumferentially spaced tabs  144  of closure cap  134  (see FIGS. 16 and 19) are received within circumferentially spaced tab receiving slots  146  formed in the fill port (FIG.  1 ). Cap  134  is provided with an elastomeric O-ring  145  so that an inward pressure exerted on the adapter assembly will effect a secure interconnection and sterile coupling of the second fill assembly with the fill port  52 . As the second fill assembly  120  is mated with the delivery component, cannula  140  of the fill assembly will pierce a pierceable septum  148  which is mounted within fill port  52  in the manner shown in FIG.  1 . 
     As best seen by referring to FIG. 17, container receiving housing  132  is provided with an elongated track  150 . Connected to container receiving housing  132  is an indicator housing  152  having an elongated track  154  that is aligned with and overlays track  150  in the manner shown in FIG.  20 . Forming an important aspect of this latest embodiment of the invention is volume control means for controlling the volume of fluid to be introduced into fluid reservoir  34  of the delivery component  20  by means of fill assembly  120 . This volume control means comprises a stop means here provided as a stop member assembly  155  which includes a push button  156  that is slidably movable within elongated tracks  150  and  154  from a first position to a second position. In a manner presently to be described, push button  156  is constructed and arranged to be engaged by container  123   a  of the fill assembly as the container is introduced into container receiving housing  132  and, in this way, functions to limit the extent of travel of the container within the container receiving housing  132 . By this mechanism, the volume of fluid contained within container  123   a  that is to be introduced into reservoir  34  of the fluid delivery component  20  can be precisely controlled. 
     Referring particularly to FIGS. 17 through 23, it is to be noted that push button  156  has an upper portion  156   a , a lower portion  156   b , and an intermediate portion  156   c . Connected to intermediate portion  156   c  is locking means for locking the stop means in position. This locking means here comprises a longitudinally extending connector member  160  (FIG. 22) to which a pair of longitudinally extending arms  162  are connected. Arms  162  which comprise the biasing means of this form of the invention, are resiliently movable relative to connector member  160  so that angularly shaped indexing tabs  166  that are provided proximate the ends of arms  162  are continuously urged into engagement with a plurality of longitudinally spaced apart locking teeth  168  that are formed on the interior surface of indicator housing  152  (FIG.  19 ). 
     With the construction described in the preceding paragraph, the stop member assembly  155  can be positioned longitudinally of container receiving housing  132  by imparting a downward force on push button  156  thus clearing tabs  166  from teeth  168  thereby enabling the assembly to be moved forwardly or rearwardly of tracks  150  and  154  with tabs  166  slidably moving within a channel  153  (see FIGS. 16A,  19  and  21 ). When the assembly is in the desired position, a release of the downward pressure exerted on push button  156  will cause indexing tabs  166  to, once again, lockably engage locking teeth  168  to lock assembly  155  in place. With the assembly thusly locked in place by the locking means, the extent of entry of container  123   a  will be positively controlled as will the volume of fluid that will be introduced into reservoir  34 . Provided on either side of track  154  are indicating indicia  167  which indicate to the user the volume of fluid that will be introduced into reservoir  34  at a particular setting of the stop assembly  155  within tracks  150  and  154 . 
     With the stop assembly properly positioned, container  123   a  can be moved into housing  132  until the container engages the lower portion  156   b  of push button  156 . As the container moves telescopically inward of housing  132 , fluid will flow from the container into cannula  130 , into central passageway  128   a  formed in pusher member  128 , into a stub passageway  132   c  and into cannula  140  via a conventional umbrella check valve  169  which is mounted within cap  134  (FIG. 19) and via passageway  134   a . Fluid will then flow through cannula  140  into passageway  39  of base  42  and finally into reservoir  34 . As the fluid under pressure enters reservoir  34 , membrane  46  will be distended in the manner shown in FIG.  1 . 
     Turning next to FIGS. 24 through 34, an alternate form of the second, or adapter fill means of the invention is there shown and generally designated by the numeral  170 . This fill means, which is also used to fill reservoir  34 , is of a general configuration shown in FIGS. 24,  25 , and  26 . Referring particularly to FIG. 24, it is to be noted that fill means  170  is also specially designed to be sealably mated with fill port assembly  52  of the fluid delivery component  20 . As illustrated in FIG. 24, fill means  170  comprises a fill assembly  24  which is identical to that previously described and an adapter assembly  174  which telescopically accepts container subassembly  60  of fill assembly  24 . 
     As before, threads  69  provided on plunger  68  of the container subassembly  60  (FIG. 6) can be threadably connected to threads  176  provided on a pusher member  178  which comprises a part of adapter assembly  174  (FIG.  26 ). Pusher member  178  also includes a cannula  180 , that is constructed and arranged to pierce the central wall  68   a  of plunger  68  when the container subassembly  60  is mated with the adapter assembly  174  (FIG.  6 ). Cannula  180  here comprises a part of the adapter flow control means of the adapter assembly for controlling fluid flow toward reservoir  34 . 
     Referring particularly to FIGS. 25,  26 ,  27 , and  28 , it can be seen that adapter subassembly  174  comprises a generally cylindrically shaped hollow container receiving housing  182  having a first open end  182   a  and a second closed end  182   b . Container subassembly  60  of the fill assembly is telescopically receivable within open end  182   a  of housing  182  so that the container component  60   a  thereof can be moved from a first extended position shown in FIG. 24 to a second advanced position wherein container  60  is at least partially encapsulated within housing  182 . 
     Also forming a part of the adapter assembly of this latest form of the invention is a connector means or cap assembly  184  (FIG. 24) which is connected to body portion  182  in the manner shown in FIG.  26 . Cap assembly  184  includes a generally cylindrical exterior wall  186 , the interior surface  186   a  of which forms a chamber  188  into which a cannula  190  extends. To interconnect fill means  170  with the fluid delivery component  20 , the barrel-like portion of closure cap  184  of the fill means is sealably mated with fill port  52  formed in base  42 . As the barrel-like portion enters the lower portion of the fill port, the circumferentially spaced tabs  194  of closure cap  184  (see FIGS. 24 and 26) are received within circumferentially spaced tab receiving slots  146  formed in the fill port (FIG.  1 ). As before, cap  184  is provided with an elastomeric O-ring  195  so that an inward pressure exerted on the adapter assembly will effect a secure interconnection and sterile coupling of the fill means with the fill port  52 . As the fill means  170  is mated with the delivery component, cannula  190  of the fill assembly will pierce the pierceable septum  148  which is mounted within fill port  52 . 
     As best seen by referring to FIGS. 25 through 32, container receiving housing  182  includes an upper, curved portion  182   c  which is provided with an elongated viewing window  197 , the purpose of which will presently be described. Connected to container receiving housing  182  and forming a continuation of upper portion  182   c  is an indicator housing  200  that houses a portion of the volume control means of this latest form of the invention for controlling the volume of fluid to be introduced into reservoir  34  (FIG.  24 ). This volume control means here comprises an internally threaded stop member  203  that is movable along a longitudinally extending track  201  that is formed within housing  182  (FIG.  28 ). As will be described in greater detail hereinafter, stop member  203  is controllably movable along track  201  by an elongated, externally threaded operating shaft  202  that is journaled for rotation with housing  182  and is rotated by operating means, which here comprises a finger-engaging control knob  204 . 
     As best seen by referring to FIGS. 28 and 32, shaft  202  includes an enlarged diameter collar portion  202   a  that is provided with a plurality of circumferentially spaced indexing grooves  205 . Received within grooves  205  is a spring tab  208  that extends downwardly from indicator housing  200  in the manner shown in FIGS. 28 and 31. Spring tab  208  functions to index operating shaft  202  within indicator housing  200 . 
     With the construction described in the preceding paragraph and as illustrated in the drawings, rotation of control knob  204  will cause rotation of shaft  202  which, in turn, will cause forward or rearward movement of stop member  203  along track  201 . As best seen by referring to FIGS. 26,  27  and  32  lower, portion  203   a  of stop member  203  extends downwardly into the interior of housing  182  so that it will be engaged by container subassembly  60  as the container subassembly is telescopically inserted into the open end  182   a  of hollow housing  182 . Accordingly, the position of stop member  203  within hollow housing  182  will control the extent of travel of the container subassembly  60  within housing  182  and thusly will control the amount of fluid contained within container  60   a  of container subassembly  60  that will be introduced into reservoir  34  of the fluid delivery component  20 . In this regard, stop member  203  is provided with an indicating arrow  203   b  (FIG. 32) which is visible through the viewing window  197  provided in housing portion  182   c . As shown in FIG. 25, volume-indicating indicia  211  are provided along viewing window  197 . The position of indicating arrow  203   b  relative to the volume-indicating indicia  211  indicates the volume of fluid that will be introduced into the reservoir of the fluid delivery component when the stop member  203  is moved to a selected position along track  201 . 
     An important feature of this latest embodiment of the invention comprises locking means for locking stop member  203  in a selected position within a hollow housing  182 . This locking means here comprises a locking pin  207  that is slidably carried within an opening  209  formed within indicator housing  200  (FIGS. 30,  33  and  34 ). Locking pin  207  includes a hexagonal-shaped shaft  207   a  that extends inwardly from a generally cylindrically shaped head portion  207   b . Shaft  207   a , which includes an enlarged diameter rib-like portion  207   c  is received within opening  209  in the manner shown in FIG.  33 . When the locking means is in the first unlocked position shown in FIG. 33, rib-like portion  207   c  is received within a circumferentially extending groove  210  formed in opening  209 . However, when the locking means is moved into the second locking position shown in FIG. 34, the inboard end of shaft  207   a  extends inwardly of a generally hexagon-shaped opening  212  formed in control knob  204  and rib-like portion  207   c  seats within a second circumferentially extending groove  213  formed within opening  209 . As shown in FIG. 34, when the locking means is in the second locked position and the inboard end of shaft portion  207   a  is received within the opening  212 , shaft  202  is securely locked against rotation. Accordingly, as long as the locking means is in the locked position shown in FIG. 34, the position of the locking member  203  within the housing  182  cannot be changed and the volume of fluid to be introduced into the reservoir of the fluid delivery component will remain unchanged. 
     In using the apparatus of this latest form of the invention, when the adapter fill means  170  is sealably interconnected with inlet port  52  of the fluid delivery component  20  and the stop member of the volume control means is appropriately set, an inward pressure exerted on container subassembly  60  will cause fluid to flow from fluid chamber  62  of the container into cannula  180 , through a fluid passageway  214 , formed in pusher member  178  and into cannula  190  via umbrella check valve  169  which is carried within cap assembly  184  (FIG.  26 ). Fluid will then flow into reservoir  34  via inlet  38  (FIG.  1 ). 
     Turning next to FIGS. 35 through 46, still another form of the second, or adapter fill means of the invention is there shown and generally designated by the numeral  215 . This fill means, which is also used to fill reservoir  34 , is similar in many respects to the embodiment shown in FIGS. 24,  25 , and  26  and like numerals are used to identify like components. Referring particularly to FIG. 35, it is to be noted that fill means  215  here comprises a pair of interconnected, back-to-back fill assemblies  217 , each of which is comparable in construction to the earlier described adapter fill means  170 . As before, fill means  215  is specially designed to be sealably mated with fill port assembly  52  of the fluid delivery component  20 . As illustrated in FIG. 35, each of the back-to-back fill assemblies  217  include a fill assembly  24  which is identical to that previously described and an adapter assembly  174  which is substantially identical to that previously described and telescopically accepts the container subassembly  60  of the fill assembly  24 . 
     As before, threads  69  provided on plunger  68  of the container subassembly  60  (FIG. 16A) can be threadably connected to threads  176  provided on pusher member  178  of each of the adapter assemblies  174  (see FIG.  36 ). Pusher member  178  also includes a cannula  180  which is constructed and arranged to pierce the central wall  68   a  of plunger  68  when the container subassembly  60  is mated with the adapter assembly  174  in the manner previously described. As before, cannula  180  comprises a part of the adapter flow control means of the adapter assembly for controlling fluid flow toward reservoir  34 . 
     Referring particularly to FIGS. 36 and 38, it can be seen that each of the back-to-back adapter subassemblies  174  is of the general construction previously described in connection with the embodiment of FIGS. 24 through 34 save for a common integral housing and each comprises a generally cylindrically shaped hollow container receiving housing  182  having a first open end  182   a  and a second closed end  182   b . Container subassembly  60  is telescopically receivable within open end  182   a  of housing  182  so that the container  60   a  thereof can be moved from a first extended position shown in FIGS. 24A and 35 to a second, advanced position wherein container  60   a  is at least partially encapsulated within housing  182 . 
     Also forming a part of the adapter fill means of this latest form of the invention is a connector means or cap assembly  184  (FIG. 35) which is connected to end portions  182   b  of housing  182  in the manner shown in FIG.  38 . As before, cap assembly  184  includes a generally cylindrical exterior wall  186 , the interior surface of which forms a chamber  188  into which a cannula  190  extends (FIG.  38 ). To interconnect fill means  215  with the fluid delivery component, the barrel-like portion of closure cap  184  is sealably mated with fill port  52  formed in base  42 . As the barrel-like portion enters the lower portion of the fill port, the circumferentially spaced tabs  194  of closure cap  184  (see FIGS. 35 and 38) are received within circumferentially spaced tab receiving slots  146  formed in the fill port (FIG.  1 ). As before, cap  184  is provided with an elastomeric O-ring  195  so that an inward pressure exerted on the adapter assembly will effect a secure interconnection and sterile coupling of the fill means with the fill port  52 . As the fill means  215  is mated with the delivery component, cannula  190  of closure cap  184  will pierce a pierceable septum  148  which is mounted within fill port  52 . Provided between cannula  190  and each of the container subassemblies  60  are flow control means, shown here as a pair of check valves  193  which, along with check valve  169 , control fluid flow toward cannula  190 . The chambers that house check valves  193  communicate with the chamber that houses check valve  169  via flow passageways  182   d . Similarly the chamber that houses check valve  169  communicates with cannula  190  via a passageway  169   a.    
     As best seen by referring to FIGS. 36 through 40, each container receiving housing  182  includes an upper, curved portion and  182   c  which is provided with an elongated viewing window  197 . Connected to each container receiving housing  182  and forming a continuation of upper portion  182   c  thereof is an indicator housing  200  that houses a portion of the volume control means of this latest form of the invention for controlling the volume of fluid to be introduced into reservoir  34 . This volume control means is identical to that previously described and operates in an identical manner. 
     As in the earlier described embodiment, the position of stop member  203  of the volume control means within each of the hollow housings  182  will control the extent of travel of the container subassembly  60  of the fill means  24  into that housing and thusly will control the amount of fluid contained within the particular container subassembly  60  that will be introduced into reservoir  34  of the fluid delivery component  20 . 
     This latest embodiment, like the earlier described embodiment, also comprises locking means for locking the stop members  203  in a selected position within each of the hollow housings  182 . This locking means is also identical in construction and operation to that described in connection with the previously discussed embodiment of the invention. As before, when the locking means of a selected one of the adapter subassemblies  174  is moved into the second, locking position shown in FIG. 46, shaft portion  207   a  of that locking means extends into a generally hexagon-shaped opening  212  formed in the outboard end of shaft  202  of that locking means and rib-like portion  207   c  seats within second circumferentially extending grooves  213  that are formed within opening  209  of the adapter subassembly. When the locking means is in the second locked position and shaft portion  207   a  is received within the opening  212 , shaft  202  is securely locked against further rotation by rotation of the control knob  204 . Accordingly, as long as the locking means is in the locked position shown in FIG. 46, the position of the locking member  203  within the selected housing  182  cannot be changed and the volume of fluid to be introduced into the reservoir of the fluid delivery component from the container of that subassembly will remain unchanged. 
     With the novel construction of this latest, dual-container subassembly embodiment, selected fluids in selected, controlled volumes can be separately or simultaneously introduced into the fluid reservoir of the fluid delivery component. 
     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.