Abstract:
A compact fluid dispenser for use in controllably dispensing fluid medicaments, such as, antibiotics, analgesics, and like medicinal agents from the device reservoir which is provided in the form of a novel bellows-type assembly. The fluid dispenser includes a unique stored energy mechanism which takes the form of a constant force spring member of novel design that provides the force necessary to continuously and substantially uniformly expel fluid from the device reservoir. The device also includes novel adjustable flow rate control assembly that is disposed intermediate the fluid reservoir outlet and the outlet port of the device for precisely controlling the rate of fluid flow from the outlet port toward the patient.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This is a Continuation-in-Part of co-pending U.S. Ser. No. 11/823,084, filed Jun. 25, 2007. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not applicable 
       INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC 
       [0003]    Not applicable 
       BACKGROUND OF THE INVENTION 
       [0004]    1. Field of the Invention 
         [0005]    The present invention relates generally to fluid dispensing devices. More particularly, the invention concerns medicament dispensers for dispensing medicinal fluids to ambulatory patients. 
         [0006]    2. Description of Related Art Including Information Disclosed Under 37 CFR 1.97 and 1.98 
         [0007]    A number of different types of medicament dispensers for dispensing medicaments to ambulatory patients have been suggested in the past. Many of the devices seek either to improve or to replace the traditional gravity flow and hypodermic syringe methods which have been the standard for delivery of liquid medicaments for many years. 
         [0008]    The prior art gravity flow methods typically involve the use of intravenous administration sets and the familiar flexible solution bag suspended above the patient. Such gravimetric 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. Accordingly, the prior art devices are not well suited for use in those instances where the patient must be transported to a remote facility for treatment. 
         [0009]    As will be fully appreciated from the discussion that follows, the devices of the present invention are particularly useful in combat situations. The ability to quickly and efficaciously treat wounded soldiers, especially in unpredictable or remote care settings, can significantly improve chances for patient survival and recovery. Accurate intravenous (IV) drug and fluid delivery technologies for controlling pain, preventing infection, and providing a means for IV access for rapid infusions during patient transport are needed to treat almost all serious injuries. 
         [0010]    It is imperative that battlefield medics begin administering life saving medications as soon as possible after a casualty occurs. The continuous maintenance of these treatments is vital until higher echelon medical facilities can be reached. A compact, portable and ready-to-use infusion device that could be easily brought into the battlefield would allow medics to begin drug infusions immediately. Additionally, it would free them to attend to other seriously wounded patients who may require more hands-on care in the trauma environment following triage. In most serious trauma situations on the battlefield, IV drug delivery is required to treat fluid resuscitation, as well as both pain and infection. Drug infusion devices currently available can impede the timely administration of IV infusions in remote care settings. 
         [0011]    Expensive electronic infusion pumps are not a practical field solution because of their weight and cumbersome size. Moreover, today&#39;s procedures for starting IV infusions on the battlefield are often dangerous because the attending medic must complete several time consuming steps. The labor intensive nature of current gravity solution bag modalities can prevent medics from attending to other patients also suffering from life threatening injuries. In some cases, patients themselves have been forced to hold infusion bags elevated in order to receive the medication by gravity drip. 
         [0012]    With regard to the prior art, one of the most versatile and unique fluid delivery apparatus developed in recent years is that developed by one of the present inventors and described in U.S. Pat. No. 5,205,820. The components of this novel fluid delivery apparatus generally include: a base assembly, an elastomeric membrane serving as a stored energy means, fluid flow channels for filling and delivery, flow control means, a cover, and an ullage which comprises a part of the base assembly. 
         [0013]    Another prior art patent issued to one of the present applicants, namely, U.S. Pat. No. 5,743,879, discloses an injectable medicament dispenser for use in controllably dispensing fluid medicaments such as insulin, anti-infectives, analgesics, oncolylotics, cardiac drugs, bio-pharmaceuticals and the like, from a pre-filled container at a uniform rate. The dispenser, which is quite dissimilar in construction and operation from that of the present invention, includes a stored energy source in the form of a compressively deformable, polymeric, elastomeric member that provides the force necessary to controllably discharge the medicament from a pre-filled container which is housed within the body of the device. After having been deformed, the polymeric, elastomeric member will return to its starting configuration in a highly predictable manner. 
       BRIEF SUMMARY OF THE INVENTION 
       [0014]    By way of brief summary, one form of the dispensing device of the present invention for dispensing medicaments to a patient comprises a supporting structure; a carriage assembly interconnected with the supporting structure for movement between a first position and a second position; a semi-rigid collapsible reservoir carried by the carriage assembly; the collapsible reservoir having an outlet port; guide means connected to the supporting structure for guiding travel of the carriage assembly between the first position and said second positions; a stored energy source operably associated with the carriage assembly for moving the carriage assembly between the first and second position; adding means for adding medicaments to the fluid within the fluid reservoir and an administration set including an administration line interconnected with the outlet port of the reservoir. 
         [0015]    Another form of the dispensing device of the invention for dispensing medicaments to a patient is similar to that described in the preceding paragraph, but the dispensing device comprises two major cooperating components, namely a dispenser unit and a separate, stand-alone additive sub-system. 
         [0016]    With the forgoing in mind, it is an object of the present invention to provide a compact fluid dispenser for use in controllably dispensing fluid medicaments, such as, antibiotics, anesthetics, analgesics, and like medicinal agents from a pre-filled dispenser at a uniform rate. 
         [0017]    Another object of the invention is to provide a small, compact fluid dispenser of simple construction that can be used in the field with a minimum amount of training. 
         [0018]    Another object of the invention is to allow infusion therapy to be initiated quickly, at will, at point of care on the battlefield so that the attending medic or medical professional can more efficiently deal with triage situations in austere environments. 
         [0019]    Another object of the invention is to provide a dispenser in which a stored energy source is provided in the form of a compressible, expandable or retractable member of novel construction that provides the force necessary to continuously and uniformly expel fluid from the device reservoir. 
         [0020]    Another object of the invention is to provide a dispenser of the class described which includes a fluid flow control assembly that precisely controls the flow of the medicament solution to the patient. 
         [0021]    Another object of the invention is to provide a dispenser that includes precise variable flow rate selection. 
         [0022]    Another object of the invention is to provide a fluid dispenser of simple construction which includes a novel adding means for adding medicaments to the fluid contained within the fluid reservoir. 
         [0023]    Another object of the invention is to provide a fluid dispenser as described in the preceding paragraph which embodies a semi-rigid collapsible container that includes a fluid reservoir that contains the beneficial agents to be delivered to the patient. 
         [0024]    Another object of the invention is to provide a fluid dispenser of the class described which is compact and lightweight, is easy for ambulatory patients to use, is fully disposable and is extremely reliable in operation. 
         [0025]    Another object of the invention is to provide a small, compact fluid dispenser that includes a housing to which vials can be connected for use in adding medicaments to the fluid within the fluid reservoir of the device. 
         [0026]    Another object of the invention is to provide a fluid dispenser as described in the preceding paragraphs that is easy and inexpensive to manufacture in large quantities. 
     
    
     
       BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS 
         [0027]      FIG. 1  is a generally perspective, top view of one form of the fluid dispensing device of the present invention for dispensing medicaments to a patient. 
           [0028]      FIG. 2  is a fragmentary, generally perspective bottom view of the front portion of the fluid dispensing device shown in  FIG. 1 . 
           [0029]      FIG. 3  is an enlarged front view of the fluid dispensing device shown in  FIG. 1 . 
           [0030]      FIG. 4  is a cross-sectional view taken along lines  4 - 4  of  FIG. 3 . 
           [0031]      FIG. 4A  is a cross-sectional view similar to  FIG. 4 , but showing the device following the collapse of the reservoir housing. 
           [0032]      FIG. 4B  is a front view of the rate control subassembly of the dispenser portion of the device. 
           [0033]      FIG. 4C  is a cross-sectional view taken along lines  4 C- 4 C of  FIG. 4B . 
           [0034]      FIG. 4D  is a view taken along lines  4 D- 4 D of  FIG. 4C . 
           [0035]      FIG. 4E  is a front view of the rate control plate of the rate control subassembly shown in  FIG. 4C  of the drawings. 
           [0036]      FIG. 4F  is a cross-sectional view taken along lines  4 F- 4 F of  FIG. 4E . 
           [0037]      FIG. 4G  is a view taken along lines  4 G- 4 G of  FIG. 4F . 
           [0038]      FIG. 5  is a generally perspective, top view of an alternate form of the fluid dispensing device of the present invention for dispensing medicaments to a patient. 
           [0039]      FIG. 6  is a fragmentary, generally perspective, bottom view of the front portion of the fluid dispensing device shown in  FIG. 5 . 
           [0040]      FIG. 7  is longitudinal, cross-sectional view of the fluid dispensing device shown in  FIG. 5 . 
           [0041]      FIG. 8  is a generally perspective, exploded view of the fluid dispensing device illustrated in  FIG. 7 . 
           [0042]      FIG. 9  is a longitudinal, cross-sectional view of the additive sub-system of the fluid dispensing device shown in  FIG. 7 . 
           [0043]      FIG. 10  is a longitudinal, cross-sectional view of the fluid dispenser portion of the device illustrated in  FIG. 7 . 
           [0044]      FIG. 11  is a generally perspective, exploded view of the additive sub-system of the fluid delivery dispenser illustrated in  FIG. 9 . 
           [0045]      FIG. 12  is a longitudinal, cross-sectional, exploded view of the additive sub-system of the fluid delivery dispenser illustrated in  FIG. 9 . 
           [0046]      FIG. 13  is a cross-sectional view taken along lines  13 - 13  of  FIG. 12 . 
           [0047]      FIG. 14  is a cross-sectional view taken along lines  14 - 14  of  FIG. 12 . 
           [0048]      FIG. 15  is a cross-sectional view taken along lines  15 - 15  of  FIG. 12 . 
           [0049]      FIG. 16  is a cross-sectional view taken along lines  16 - 16  of  FIG. 12 . 
           [0050]      FIG. 17  is a cross-sectional view taken along lines  17 - 17  of  FIG. 12 . 
           [0051]      FIG. 18  is a top view of the reservoir housing of the fluid dispenser portion of the device. 
           [0052]      FIG. 19  is a cross-sectional view taken along lines  19 - 19  of  FIG. 18 . 
           [0053]      FIG. 20  is an exploded, cross-sectional view of the upper neck portion of the reservoir housing of the fluid dispenser portion of the device shown in  FIG. 19 . 
           [0054]      FIG. 21  is a top view of the rate control knob of the fluid dispenser portion of the device. 
           [0055]      FIG. 22  is a view taken along lines  22 - 22  of  FIG. 21 . 
           [0056]      FIG. 23  is a bottom view of the rate control knob of the fluid dispensing portion of the device. 
           [0057]      FIG. 24  is a cross-sectional view taken along lines  24 - 24  of  FIG. 23 . 
           [0058]      FIG. 25  is a cross-sectional view taken along lines  25 - 25  of  FIG. 23 . 
           [0059]      FIG. 26  is a front view of the carriage locking and release member of the additive sub-system. 
           [0060]      FIG. 27  is a cross-sectional view taken along lines  27 - 27  of  FIG. 26 . 
           [0061]      FIG. 28  is a fragmentary, cross-sectional view of one end of the additive sub-system of the invention illustrating the carriage locking and release member in a carriage locking position. 
           [0062]      FIG. 29  is a cross-sectional view taken along lines  29 - 29  of  FIG. 28 . 
           [0063]      FIG. 30  is a cross-sectional view, similar to  FIG. 28 , but showing the carriage locking and release member in a carriage release position. 
           [0064]      FIG. 31  is a cross-sectional view taken along lines  31 - 31  of  FIG. 30 . 
           [0065]      FIG. 32  is a longitudinal, cross-sectional view, similar to  FIG. 7 , but showing the configuration of the dispenser following filling of the fluid reservoir. 
           [0066]      FIG. 33  is a cross-sectional view taken along lines  33 - 33  of  FIG. 32 . 
           [0067]      FIG. 34  is a cross-sectional view of the additive sub-system of the invention further illustrating the carriage locking and release member in a carriage locking position and showing the fill-vial in a filled condition. 
           [0068]      FIG. 35  is a cross-sectional view taken along lines  35 - 35  of  FIG. 34 . 
           [0069]      FIG. 36  is a fragmentary, cross-sectional view of the forward end of the additive sub-system of the invention illustrating the main check valve in a sealing configuration. 
           [0070]      FIG. 37  is a cross-sectional view similar to  FIG. 34 , but showing the carriage locking and release member in a carriage release position and showing the fill-vial as it appears following filling of the reservoir of the dispenser portion of the device. 
           [0071]      FIG. 38  is a longitudinal, cross-sectional view, similar to  FIG. 32 , but showing the configuration of the dispenser following expelling of the fluid from the fluid reservoir. 
           [0072]      FIG. 39  is a front view of the rate control subassembly of the dispenser portion of the device. 
           [0073]      FIG. 40  is a cross-sectional view taken along lines  40 - 40  of  FIG. 39 . 
           [0074]      FIG. 41  is a view taken along lines  41 - 41  of  FIG. 40 . 
           [0075]      FIG. 42  is a front view of the rate control plate of the rate control subassembly shown in  FIG. 40  of the drawings. 
           [0076]      FIG. 43  is a cross-sectional view taken along lines  43 - 43  of  FIG. 42 . 
           [0077]      FIG. 44  is a view taken along lines  44 - 44  of  FIG. 43 . 
           [0078]      FIG. 45  is a fragmentary, cross-sectional view of the forward end of an alternate form of the additive sub-system of the invention illustrating the main check valve in a sealing configuration. 
           [0079]      FIG. 46  is a longitudinal, cross-sectional view of the alternate form of additive sub-system shown interconnected with the upper portion of the dispenser unit. 
           [0080]      FIG. 47  is a longitudinal, cross-sectional view of the alternate form of additive sub-system, similar to  FIG. 46 , but showing the carriage locking and release member in a carriage release position and showing the fill-vial as it appears following filling of the reservoir of the dispenser unit portion of the device. 
           [0081]      FIG. 48  is an enlarged cross-sectional view taken along lines  48 - 48  of  FIG. 46 . 
           [0082]      FIG. 49  is a longitudinal, cross-sectional view of another form of the additive sub-system of the invention. 
           [0083]      FIG. 50  is a longitudinal, cross-sectional view of the fluid dispenser portion of the device with which the additive sub-system illustrated in  FIG. 49  can be mated. 
           [0084]      FIG. 51  is a longitudinal, cross-sectional view of the fluid dispenser portion of the device showing the additive sub-system illustrated in  FIG. 49  mated therewith. 
           [0085]      FIG. 52  is a top view of the reservoir housing of the fluid dispenser portion of the device shown in  FIG. 51 . 
           [0086]      FIG. 53  is a cross-sectional view taken along lines  53 - 53  of  FIG. 52 . 
           [0087]      FIG. 54  is an exploded, cross-sectional view of the upper neck portion of the reservoir housing of the fluid dispenser portion of the device shown in  FIG. 53 . 
           [0088]      FIG. 55  is a longitudinal, cross-sectional view, similar to  FIG. 51 , but showing the fill-vial as it appears following filling of the reservoir of the dispenser unit portion of the device. 
           [0089]      FIG. 56  is a longitudinal, cross-sectional view of the additive sub-system of the invention that is similar to the additive sub-system shown in  FIG. 49 . 
           [0090]      FIG. 57  is a longitudinal, cross-sectional view of the fluid dispenser portion of the device with which the additive sub-system illustrated in  FIG. 56  can be mated. 
           [0091]      FIG. 58  is a longitudinal, cross-sectional view showing the additive sub-system illustrated in  FIG. 56  mated with the dispenser unit, but showing the fill-vial as it appears following filling of the reservoir of the dispenser unit portion of the device. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0092]    Referring to the drawings and particularly to  FIGS. 1 through 4 , one form of the dispensing device of the present invention for dispensing medicaments to a patient is there shown and generally designated by the numeral  70 . The dispensing device here includes a housing  72  which includes a control portion  74  and a generally cylindrically shaped reservoir housing  76  that is interconnected with the control portion  74  in the manner best seen in  FIG. 4  of the drawings. Housing  72  can be constructed from metal, plastic or any suitable material. Reservoir housing  76  includes a generally cylindrically shaped wall portion  76   a  and a base portion  76   b.    
         [0093]    Disposed within wall portion  76   a  is a carriage assembly  78  which is movable between a first position shown in  FIG. 4  and a second position shown in  FIG. 4A . As best seen by referring to  FIG. 4 , carriage assembly  78  comprises a carriage  80  having a carriage base  80   a  that is provided with a plurality of circumferentially spaced openings  82  and a generally cylindrically shaped sidewall  80   b  which terminates in circumferentially spaced, radially outwardly extending flanges  80   c . Carriage assembly  78  is releasably locked in its first position by a novel locking means the character of which will presently be described. 
         [0094]    Carried by carriage assembly  78  is a semi-rigid reservoir defining assembly  84  that defines a fluid reservoir  85 . As indicated in  FIG. 4 , reservoir defining assembly  84  comprises a top wall  86 , a bottom wall  88  and an accordion-like side wall  90 . Connected to top wall  86  is a neck portion  94  that is sealed by a closure wall  92   a.    
         [0095]    In the preferred form of the invention reservoir defining assembly  84  is formed in accordance with an aseptic blow-fill seal manufacturing technique which is of a character well understood by those skilled in the art. This technique involves the continuous plastic extrusion through an extruder head of a length of parison in the form of a hollow tube between and through two co-acting first or main mold halves. The technique further includes the step of cutting off the parison below the extruder head and above the main mold halves to create an opening which allows a blowing and filling nozzle assembly to be moved downwardly into the opening in the parison for molding the molded container. Further details concerning the technique are available from Rommelag GMBH of Stutgart, Germany and Weiler Engineering of Elgin, Ill. 
         [0096]    In a manner presently to be described, a collapsible container is accessible via a penetrating member  93  that is adapted to pierce closure wall  92   a  as well as a pierceable membrane  95  which is positioned over closure wall  92   a  by means of a closure cap  97  which is affixed to the neck portion  94  of container assembly  84  ( FIG. 4 ). As previously described, the basic container  84  is formed using the earlier described aseptic blow-fill technique and the reservoir portion of the container is sealed by the thin closure wall  92   a . The piercable membrane  95  is then positioned over the closure wall and the closure cap  97  is positioned over the piercable septal membrane and secured to neck portion  94  by any suitable means such as adhesive bonding, sonic or heat welding. 
         [0097]    An important feature of the invention resides in the provision of novel guide means for guiding travel of carriage assembly  78  between the first position shown in  FIG. 4  and a second position. In the present form of the invention this important guide means comprises a plurality of circumferentially spaced guide members  99  which are connected to and extend outwardly from body  74   a  of control portion  74  ( FIG. 4 ). As indicated in the drawings, guide members  99  are slidably received within openings  82  provided in carriage base  80   a  ( FIG. 4 ) so that, as the carriage assembly travels from its first position toward its second position, guide members  99  precisely guide its travel. Also forming a part of the guide means of the apparatus of the present invention are a plurality of circumferentially spaced guide grooves  101  that are formed on the inner wall of outer housing  76  ( FIG. 4 ). 
         [0098]    To controllably move the carriage assembly from its first position to its second position, novel stored energy means are provided. This novel stored energy means, which is operably associated with carriage assembly  78 , is here provided in the form of a coiled spring  104 . As illustrated in  FIG. 4 , one end  104   a  of the coil spring  104  is disposed in engagement with the threaded base portion  76   b  of reservoir housing  76  and the other end  104   b  thereof is disposed in engagement with radially outwardly extending flange segments  80   c  of carriage  80 . With this construction, following penetration of the reservoir septum, and when the locking means of the invention is manipulated in a manner to unlock the carriage assembly from base portion  76   b  of the outer housing, spring  104  will move from its retracted position shown in  FIG. 4  to its expanded position shown in  FIG. 4A , and in so doing will controllably move the carriage assembly from its starting position shown in  FIG. 4  to its fully deployed or extended position and in so doing will controllably move the carriage assembly from its starting position shown in  FIG. 4  to its fully deployed or extended position. As will be described more fully in the paragraphs that follow, as the carriage assembly moves toward its deployed position, the accordion-like side wall  90  of the reservoir defining container will move into the collapsed configuration and in so doing will cause the medicinal fluid contained within the container to be controllably expelled therefrom. 
         [0099]    Forming an important aspect of the apparatus of the present invention is adding means carried by portion  76  of housing  72  for adding injectable medicaments to the fluid within the fluid reservoir  85 . The details of construction and operation of this important adding means will presently be discussed. As best seen in  FIG. 4 , body  74   a  of control portion  74  includes a fluid passageway  108  that is in communication with the fluid passageway of penetrating member  93  via passageways  110  and  111 . Proximate its outer extremity  108   a , fluid passageway  108  communicates with a cavity  112  formed within control portion  74  (See  FIG. 4 ). Disposed within cavity  112  is a porous filter  114  which comprises a part of the vent means “V” of this latest form of the invention for venting to atmosphere any gasses that would otherwise be trapped within the fluid passageways of the device during the medicament adding step. Filter  114 , which is of a conventional construction such as hydrophobic-treated, sintered metal or porous membrane, is held in position by a retainer  114   a.    
         [0100]    Control portion  74  of housing  72  also includes a vial housing  116  having a chamber  116   a  for telescopically receiving a medicament containing reconstitution-type fill-vial  118 . An elongated vial  120 , which is disposed within chamber  116   a , along with first and second spacers  122  and  124 , function to hold vial  118  in a proper position within chamber  116   a . Vial  120  is telescopically receivable within a vial tube  126 , which in turn carries a pusher member  128 , the purpose of which will presently be described. Also carried by control portion  74  in close proximity with vial  120  is a needle holding component  130 . As shown in  FIG. 4 , needle holding component  130  carries a longitudinally extending, elongated hollow needle  132  having a flow passageway  132   a  that communicates with fluid passageway  108  via a stub passageway  134  and a conventional check valve  136  which is carried by a check valve housing  138 . Vial  118 , vial  120 , vial tube  126 , needle holding component  130  and hollow needle  132  together comprise one form of the adding means of the device of the present invention. The method of operation of this important adding means will presently be described. 
         [0101]    Referring particularly to  FIG. 4 , the medicament containing fill-vial  118  comprises a container of special design that uniquely contains a lyophilized drug  142 . Vial  118  is sealed at one end by a slidable elastomeric plunger  144  and at the other end by a pierceable septum  146 . Formed intermediate the ends of the vial is a raised outer wall by-pass portion  118   a , which permits the fluid “F” that is contained within a chamber  148  to bypass a barrier stopper  150  as the barrier stopper is urged inwardly of the container by pressure exerted thereon by the fluid, which is being pushed by plunger  144  resulting from force exerted on pusher element member  128  (see  FIG. 4 ). 
         [0102]    A continued inward pressure exerted on plunger  144  will cause fluid “F” to flow past barrier member  150  via the internal passageway defined wall portion  118   a  so as to reconstitute the lyophilized drug  142 . A continued pressure exerted on plunger  144  by the pusher member will cause the reconstituted drug formed by the fluid “F” which has been intermixed with drug to flow through hollow needle  132 , into a chamber  138   a  formed in check valve housing  138 , past check valve  136 , into a stub passageway  134 , then into passageway  108  and finally into the device reservoir  85 . 
         [0103]    Device reservoir  85  and reconstitution medicament containing fill-vial  118  can be of various volumes ranging from about 5 ml to about 50 ml. 
         [0104]    To control the flow of medicinal fluid from the adding means into the reservoir  85  and then, during the fluid dispensing step, out of reservoir  85  toward the administration set  162  of the invention, novel flow control means are provided. This novel fluid flow control means, which is housed within the control portion  74  of the device, here comprises two cooperating components, namely a rate control means for controlling the rate of fluid flow from the semi-rigid collapsible reservoir toward the administration set and an operating means for controlling fluid flow from the adding means into the reservoir  85  and then, after the reservoir has been filled, out of reservoir  85  toward the rate control means. 
         [0105]    Considering first the operating means of the invention, this important means, which first controls fluid flow from the adding means toward the reservoir  85  and subsequently controls fluid flow between collapsible reservoir  85  and the rate control means, here comprises a control knob  150  that is rotatably mounted on body  74   a  of control portion  74 . As best seen in  FIG. 4 , control knob  150  is held in position on body  74   a  by a knob retaining ring  152 . Control knob  150 , which is provided with control indicia  153  ( FIG. 3 ), has an axial bore  154  having threads that threadably receive the head portion  156   a  of an elongated needle housing  156  that carries penetrating member  93  ( FIGS. 4 and 4A ). With this construction, an initial rotation of knob  150  will cause the needle housing  156  to controllably move from the position shown in  FIG. 4  to the fill position, wherein fluid passageway  111  aligns with fill passageway  108  formed in control body portion  74   a . This initial rotation of control knob  150  will also cause penetrating member  93  to pierce both septal membrane  95  as well as closure wall  92   a  of the reservoir container. This movement of the housing  156  and the penetrating member  93  opens fluid communication between the fill-vial  118  and the fluid reservoir  85  via penetrating needle  93 , the opened check valve  136 , stub passageway  134 , fill passageway  108 , stub passageway  111 , and the internal fluid flow passageway of penetrating member  93 . In the manner previously discussed, an inward force exerted on pusher member  128  will cause the fluid “F” to flow past barrier member  150  via the internal by-pass passageway defined by wall portion  118   a  so as to reconstitute the lyophilized drug  142 . A continued pressure exerted on plunger  144  by the pusher member will cause the reconstituted drug formed by the fluid “F”, which has been intermixed with the drug, to flow through penetrating needle  132  and then on to the fluid reservoir  85 . After the reservoir is filled, check valve  136  will return to its initial closed position shown in  FIG. 4  blocking reverse fluid flow from collapsible reservoir  85  toward fill-vial  118 . 
         [0106]    To prevent accidental rotation of control knob  150 , the operating means further includes indexing means, here provided in the form of an indexing button  157 . This important indexing means functions to prevent rotation of the control knob until the indexing button, which is pivotally mounted on the side of the control portion of the device ( FIG. 4 ), is pivoted inwardly. The skirt portion  150   a  of the control knob is provided with a plurality of circumferentially spaced notches  150   b  that closely receive a locking tab  157   a  formed on indexing button  157  when the button is biased toward its outward locking position. To accomplish the initial rotational step, described in the preceding paragraph, the indexing button  157  is pushed inwardly to move the locking tab  157   a  out of engagement with the notch within which it resides and the control knob is rotated from the “OFF” position ( FIG. 3 ) to the “FILL” position. Release of the indexing button will then cause the outwardly biased locking tab  157   a  to move into engagement with an appropriate locking notch so as to lock the control knob in the “FILL” position. 
         [0107]    After the diluent reservoir-filling step has been completed in the manner previously described, the fluid contained within the field reservoir can be dispensed to the patient by once again pivoting the indexing button  157  inwardly to move the locking tab  157   a  out of engagement with the notch within which it resides. This done, the control knob can be further rotated to the “DEL.” position thereby causing the needle housing  156  to controllably move from the position shown in  FIG. 4  to the fluid delivery position shown in  FIG. 4A . In this position fluid passageway  170  aligns with dispensing passageway  172  formed in control body portion  74   a  so that fluid can flow from reservoir  85  toward the administration set  162  via the flow rate control means of the invention the character of which will presently be described. 
         [0108]    To cause the fluid to flow from reservoir  85  toward the flow rate control means, the locking means of the invention must be manipulated in a manner to release the carriage assembly from base wall  76   b  of reservoir housing  76 . In this regard, as best seen in  FIG. 4 , the carriage locking means includes a locking member  164  having a yieldably deformable locking tab  164   a  which extends through a strategically shaped opening  166  provided in the base wall  76   b  of reservoir housing  76 . With this construction, an inward force exerted on the locking member will deform the locking tab  164  in a manner to permit it to pass through the opening  166  and in so doing release the carriage from the base wall  76   b . Release of the carriage will permit the stored energy means, or coiled spring  104 , to move the carriage from a position shown in  FIG. 4  into the extended position. As the semi-rigid, accordion-like side wall of the container collapses due to the urging of the coiled spring, the medicinal fluid contained within the container will be controllably expelled therefrom and will flow toward the fluid passageway of penetrating member  93  which has now moved into a downward position. From the fluid passageway of penetrating member  93 , fluid will flow into a stub passageway  170  formed in needle housing  156 . With the penetrating member in its downward position, stub passageway  170  is aligned with a passageway  172  which forms the inlet to the fluid rate control means of the invention. 
         [0109]    Referring to  FIGS. 4A through 4G , the important fluid rate control means of the invention comprises a rate control housing  174 , which includes a front cover  176  having an inlet  176   a  and an outlet  176   b . Rate control housing  174  also includes a back cover  178  having an inlet  178   a  and an outlet  178   b . Disposed between the front and back cover is a novel rate control plate  180  having a uniquely configured, circuitous fluid flow channel  180   a  formed on the first surface  180   b  thereof and a substantially linear fluid flow channel  180   c  formed on the second surface  180   d  thereof. 
         [0110]    With the construction described in the preceding paragraphs, as the accordion-like side wall of the fluid container collapses in a controlled manner, fluid will flow from reservoir  85  into the flow passageway of penetrating member  93 , into stub passageway  170  and then into the inlet passageway  176   a  of the rate control means. From passageway  172 , the fluid will flow into the inlet  176   a  of front cover  176  and then into inlet  181  of rate control plate  180 . The fluid will then flow through the circuitous fluid flow channel and into the inlet of the linear fluid flow channel. Next, the fluid will flow through outlet  185  into inlet  178   a  of back cover  178 , outwardly through outlet  178   b  thereof and then into an elongated passageway  194  formed in body  74   a  of control portion  74 . From the elongated channel  194  the fluid will flow onward to the administration set  162  and then to the patient. It is apparent that by varying the geometry, including the length, width and depth of the flow control channel  180   a , the rate of fluid flow to the administration set and to the patient can be readily varied. 
         [0111]    As best seen in  FIG. 3 , administration set  162  is sealably connected to the control portion  74  by a connector  195  so that the proximal end  162   a  of administration line  162  of the administration set is in communication with an outlet fluid passageway  194 . Disposed between the proximal end  162   a  and the distal end  162   b  of the administration line are a conventional clamp  197 , a conventional gas vent and a conventional filter  199  and an injector site  198 . Provided at the distal end  162   b  of the administration line is a luer connector  201  and luer cap  203  of conventional construction (See  FIG. 1 ). 
         [0112]    To accomplish residual drug recovery from reservoir  85  as may be required, recovery means are provided. In this regard, as best seen in FIG.  4 , a stub passageway  205  formed in body  74   a  also communicates with fluid passageway  194 . Stub passageway  205  also communicates with a cavity  205   a  formed in body  74   a . Sealably mounted within cavity  205   a  is a non-coring pierceable septum  205   b  ( FIG. 4 ) which is pierceable by the needle of a conventional syringe that can be used to accomplish residual drug recovery from reservoir  85 . 
         [0113]    As illustrated in  FIG. 1 , housing  76  is provided with a belt clip receiving member  206  to which a belt clip  208  can be slidably interconnected. When the belt clip  208  is connected with receiving member  206  the device can be conveniently carried on the user&#39;s belt during the medicament dispensing step. 
         [0114]    Referring now to  FIGS. 5 through 10 , an alternate form of the dispensing device of the present invention for dispensing medicaments to a patient is there shown and generally designated by the numeral  280 . The apparatus of this latest embodiment is similar to that previously described, but the dispensing device here comprises two major cooperating components, namely a dispenser unit  282  and a separate, stand-alone additive sub-system  284 . Dispenser unit  282  includes an outer housing  283 , which comprises a control portion  285  and a generally cylindrically shaped reservoir housing  286  that is interconnected with the control portion  285  in the manner best seen in  FIG. 7  of the drawings. Additive sub-system  284 , the details of construction and operation of which will presently be described, is also operably interconnected with the control portion  285  in the manner best seen in  FIG. 7 . As shown in  FIGS. 7 and 10 , reservoir housing  286 , which can be constructed from metal, plastic or any suitable material, includes a generally cylindrically shaped wall portion  286   a  and a base portion  286   b.    
         [0115]    Disposed within wall portion  286   a  is a carriage assembly  288  ( FIGS. 7 ,  8  and  10 ), which is movable between a first position shown in  FIG. 7  and a second position shown in  FIG. 38 . As best seen by referring to  FIG. 8 , carriage assembly  288  comprises a carriage having a carriage base  290   a  that is provided with a plurality of circumferentially spaced openings  292  and a generally cylindrically shaped sidewall  290   b  which terminates in circumferentially extending flange  290   c . Carriage assembly  288  is releasably locked in its first position by a novel locking means the character of which will presently be described. 
         [0116]    Carried by carriage assembly  288  is a reservoir-defining assembly  294  that defines a fluid reservoir  295 . As indicated in  FIGS. 18 ,  19  and  20 , reservoir-defining assembly  294  comprises a top wall  296 , a bottom wall  298  and an accordion-like sidewall  300 . Connected to top wall  296  is a neck portion  302  that is sealed by a closure wall  302   a  ( FIGS. 19 and 20 ). 
         [0117]    In the preferred form of the invention, reservoir-defining assembly  294  is formed in accordance with an aseptic blow-fill seal technique which is of a character well understood by those skilled in the art. This technique involves the continuous extrusion through an extruder head of a length of parison in the form of a hollow tube between and through two co-acting first or main mold halves. The technique further includes the step of cutting off the parison below the extruder head and above the main mold halves to create an opening which allows a blowing and filling nozzle assembly to be moved downwardly into the opening in the parison for molding the molded container. 
         [0118]    In a manner presently to be described, the collapsible container is accessible via a penetrating member  303  that is adapted to pierce closure wall  302   a  as well as a pierceable membrane  305  ( FIGS. 18 and 19 ) which is positioned over closure wall  302   a  of by means of a closure cap  307  which is affixed to the neck portion  302  of container assembly  294  ( FIG. 19 ). As previously described, the basic container  294  is formed using the earlier described aseptic blow-fill technique and the reservoir portion of the container is sealed by the thin closure wall  302   a . The piercable membrane  305  is then positioned over the closure wall and the closure cap  307  is positioned over the piercable membrane and secured to neck portion  302  by any suitable means such as adhesive bonding or sonic welding. 
         [0119]    An important feature of the invention resides in the provision of novel guide means for guiding travel of carriage assembly  288  between the first position shown in  FIG. 7  and the second position shown in  FIG. 38 . In the present form of the invention this important guide means comprises a plurality of circumferentially spaced guide members  309  which are connected to and extend outwardly from body  285   a  of control portion  285  ( FIGS. 7 and 8 ). As indicated in the drawings, guide members  309  are slidably received within openings  292  provided in carriage base  290   a  ( FIG. 8 ) so that as the carriage assembly travels from its first position toward its second position, guide members  309  precisely guide its travel. Also forming a part of the guide means of the apparatus of the present invention are a plurality of circumferentially spaced guide grooves  311  that are formed on the inner wall of outer housing  286  ( FIG. 7 ). 
         [0120]    To controllably move the carriage assembly from its first position to its second position, novel stored energy means are provided. This stored energy means, which is operably associated with carriage assembly  288 , is here provided in the form of a coiled spring  314 . As illustrated in  FIGS. 7 and 10 , one end  314   a  of the coil spring  314  is disposed in engagement with the threaded base portion  286   b  of reservoir housing  286  and the other end  314   b  thereof is disposed in engagement with radially outwardly extending flange segments  290   c  of carriage  288 . With this construction, when, as will presently be described, the operating means of the invention has been operated in a manner to place the device in the fluid delivery mode and when the locking means of the invention is manipulated in a manner to unlock the carriage assembly from base portion  286   b  of the outer housing, spring  314  will move from its retracted position shown in  FIG. 7  to its expanded position shown in  FIG. 38 . As the spring moves toward its expanded position it will controllably move the carriage assembly from its starting position shown in  FIG. 7  to its fully deployed, or extended position shown in  FIG. 38 . As will be described more fully in the paragraphs which follow, as the carriage assembly moves toward its deployed position, the accordion-like side wall  300  of the reservoir-defining container will move into the collapsed configuration shown in  FIG. 38  and in so doing will cause the medicinal fluid contained within the container to be controllably expelled therefrom. 
         [0121]    To control the flow of medicinal fluid from the reservoir  295  toward the administration set  318  of the invention ( FIG. 5 ), novel flow control means are provided. This novel fluid flow control means, which is housed within the control portion  285  of the device, here comprises two cooperating components, namely a rate control means for controlling the rate of fluid flow from the collapsible reservoir toward the administration set and the previously mentioned operating means for controlling fluid flow into and out of the fluid reservoir  295 . 
         [0122]    Considering first the operating means of the invention, this important means, here comprises reservoir accessing means for accessing the fluid reservoir  295  that includes a control knob  320  ( FIGS. 5 ,  7 ,  8 ,  10 ,  21  and  22 ) that is rotatably mounted on body  285   a  of control portion  285  and penetrating means for penetrating both membrane  305  as well as closure wall  302   a  of the reservoir container. As best seen in  FIGS. 7 and 8 , the control knob  320  is held in position on body  285   a  by a knob retaining ring  322 . Control knob  320 , which is provided with control indicia  323  ( FIG. 21 ), has an axial bore  324  having threads  324   a  that threadably receive the head portion  326   a  of an elongated needle housing  326  that carries penetrating member  303  of the previously identified penetrating means of the invention ( FIGS. 7 ,  8  and  22 ). With this construction, an initial rotation of knob  320  will cause the needle housing  326  to controllably move from the position shown in  FIG. 7  to the position shown in  FIG. 32 , wherein fluid passageway  328  aligns with passageway  330  formed in control body portion  285   a.    
         [0123]    As indicated in  FIG. 32 , rotation of control knob  320  will also cause penetrating member  303  to pierce both membrane  305  as well as closure wall  302   a  of the reservoir container. With the additive sub-system  284  interconnected with the dispenser unit in the manner shown in  FIG. 7 , this movement of the needle housing  326  and the penetrating member  303  opens fluid communication between the additive sub-system  284  and the fluid reservoir  295  via passageway  330 , stub passageway  328  and the internal fluid flow passageway  303   a  of penetrating member  303 . 
         [0124]    To prevent accidental rotation of control knob  320 , indexing means, here provided in the form of an indexing button  334 , functions to prevent rotation of the control knob until the indexing button, which is pivotally mounted on the side of the control portion of the device ( FIGS. 7 and 8 ), is pivoted inwardly of a cavity  335  formed in body  285   a  of control portion  285 . As illustrated in  FIGS. 8 and 22  of the drawings, the skirt portion  320   a  of the control knob is provided with a plurality of circumferentially spaced notches  320   b  that closely receive a locking tab  334   a  ( FIG. 8 ), formed on indexing button  334  when the button is biased toward its outward locking position shown in  FIG. 7  by a living hinge  334   c  that interconnects a finger  334   d  with the body portion  334   e  of the indexing button ( FIG. 8 ). To accomplish the initial rotational step, described in the preceding paragraph, the indexing button  334  is pushed inwardly to move the locking tab  334   a  out of engagement with the notch within which it resides and the control knob is rotated from the “OFF” position ( FIG. 21 ) to the “ADD” position. Release of the indexing button will then cause the outwardly biased locking tab  334   a  to move into engagement with an appropriate locking notch so as to lock the control knob in the “ADD” position. 
         [0125]    Considering now the details of the construction and operation of the form of the additive sub-system shown in  FIGS. 9 ,  11  and  12  and generally designated by the numeral  284 ; this important additive sub-system here comprises a vial housing  340  having a chamber  340   a  for telescopically receiving the novel medicament containing, bellows-type, collapsible fill-vial  342 . Chamber  340   a  is initially sealed at one end by a seal cover  343  and at the other end by an end wall  340   e . In the present form of the invention, dispenser reservoir  295  and medicament containing vial of the vial assembly  340  can be of various volumes ranging from about 5 ml to about 50 ml. 
         [0126]    As shown in  FIGS. 7 and 8 , vial housing  340  has a forward wall  340   b  that includes a generally cylindrical, forwardly extending portion  340  that is receivable within an internal chamber  344   a  formed in a check valve housing  344 . Check valve housing  344  has a forwardly extending portion  344   b  that is receivable within an internal chamber  285   c  formed in connector control portion  285 . Mounted within internal chamber  344   a  of the check valve housing is a check valve actuator  345  the construction and operation of which will later be described. 
         [0127]    Formed in the lower surface  340   d  of connector housing  340  is a dove tail receiving groove  340   c  ( FIGS. 8 and 11 ), the purpose of which will presently be described. Also forming a part of the additive sub-system  284  of the invention is a carriage assembly  346  ( FIGS. 9 ,  11  and  12 ), which is movable between a first position shown in  FIGS. 7 and 9  to a second position shown in  FIG. 32 . Carriage assembly  346  here comprises a carriage  348  having a carriage base  348   a  having a plurality of circumferentially spaced openings  349   a  and a generally cylindrically shaped sidewall  348   b  which terminates in a circumferentially extending flange  348   c . Carriage assembly  346  is releasably locked in its first position by a novel locking means the character of which will presently be described. 
         [0128]    Carried by carriage assembly  346  is the previously identified bellows-type, collapsible fill-vial  342  that defines a fluid reservoir  351 . As indicated in  FIG. 12  fill-vial  342  comprises a flange portion  352 , a closure wall  354  and an accordion-like sidewall  356 . In the preferred form of the invention, the bellows-type, collapsible fill-vial  342  is blow-molded in a manner well understood by those skilled in the art. 
         [0129]    Flange portion  352  of the vial  342  is closely receivable within an annular groove  360  formed in forward wall  340   b  of additive housing  340 . As indicated in  FIG. 12  of the drawings, the generally cylindrical portion  340   f  of the forward wall, which here comprises a main check valve housing, is provided with an internal chamber  364  that is in communication with the fluid reservoir  351  via an inlet port  366 . Connected to forward wall  340   b  and extending into fluid reservoir  351  is an ullage member  351   a , the purpose of which will presently be described. 
         [0130]    Mounted within the chamber  364  of the main check valve housing is a novel yieldably deformable check valve  368  that functions to prevent fluid flow outwardly of fluid reservoir  351  until the additive sub-system  284  is interconnected with the dispenser unit  285 . More particularly, as the additive sub-system is mated with the dispenser unit, check valve  368  will be deformed by the neck portion  345   a  of the actuator member  345  ( FIG. 32 ) from the first sealing configuration shown in  FIG. 36  wherein the fluid flow from reservoir  351  is blocked from flowing through the fluid passageways  370  formed in portion  344   b  by the sealing shoulders  368   a  of the check valve  368  which are in sealing engagement with the check valve retainer member  372  to the second configuration shown in  FIGS. 34 and 37 . As indicated in  FIG. 37 , as the additive sub-system is mated with the dispenser unit, the neck portion  345   a  of the valve actuator  345  will urge the check valve  368  inwardly in a manner such that the sealing shoulders  368   a  of the check valve  368  will be separated from the check valve retainer member  372  thereby permitting fluid flow through the fluid passageway  372   a  in the direction of the arrows  373 . 
         [0131]    The reservoir fill step for filling reservoir  FIG. 37  from the additive subsystem  295  of the dispenser  285  is accomplished by first removing sterile cover  343 . Next, the additive sub-system  284  of the device is interconnected with the control portion  285  of the dispenser unit in the manner illustrated in  FIG. 7 . More particularly, as shown in  FIGS. 8 and 11 , reservoir housing  286  is provided with a dovetail connector segment  286   c  that is slidably received within the groove  340   c  formed in connector housing  340 . 
         [0132]    As indicated in  FIG. 7 , when the dovetail connector segment  286   c  is mated with and urged forwardly of the dovetail receiving groove  340   c  formed in connector housing  340 , cylindrical portion  340   f  of front wall  340   b  will be telescopically received and seated within internal chamber  344   a  of connector portion  344 . 
         [0133]    When the dovetail connector segment  286   c  is mated with and urged forwardly of the dovetail receiving groove  340   c  formed in connector housing  340 , cylindrical portion  340   f  of front wall  340   b  will be telescopically received and seated within internal chamber  344   a  of connector portion  344  and the check valve will be deformed in a manner previously described so that the sealing shoulders  368   a  of the check valve  368  will be separated from the check valve retainer member  372 . With the additive sub-system thusly interconnected with the dispenser component, the carriage lock  382 , which is carried within a slot  379  formed in end wall  340   e  of housing  340 , is manipulated in a manner to release carriage  346 . More particularly, as best seen and  FIGS. 26 through 31 , carriage lock  380  comprises a central body portion  380   a  to which a pair of spaced-apart, yieldably deformable side members  380   b  and a yieldably deformable bottom member  380   c  are connected. Bottom member  380   c  continuously urges the carriage lock  380  toward the at-rest position shown in  FIG. 29 . Central body portion  380   a  is provided with an opening  381  that is adapted to receive the hook-like locking protuberance  382  that is connected to and extends outwardly from base wall  348   a  of the carriage assembly  346 . When the carriage lock  380   c  is in its at-rest position shown in  FIG. 29  of the drawings, the locking elements  383  formed at the extremities of side members  380   b  are retained within locking slots  385  formed in wall  340   e . When a downward force is exerted on the locking member, the side members  380   b , along with bottom member  380   c  will be yieldably deformed in the manner shown in  FIG. 31  of the drawings. This downward movement of the carriage lock from the at-rest locking position shown in  FIG. 29  to the downward position shown in  FIG. 31  will cause the opening  381  to move downwardly a sufficient distance to release the hook-like protuberance in the manner shown in  FIG. 30 . 
         [0134]    Release of the hook-like protuberance  382  will permit the coiled spring  386 , which is carried within housing  340  in the manner shown in  FIGS. 28 and 30 , to urge the carriage assembly  346  forwardly of housing  340  from the position shown in  FIG. 28  the position shown in  FIG. 30 . Forward movement of the carriage will be guided by the plurality of spaced-apart guide members  390  that are mounted within the housing  340  and are received within the circumferentially spaced slots  349   a  formed in carriage base  348   a . As the carriage moves forwardly the bellows-like sidewall of the fluid containing vial  342  will collapse in the manner shown in  FIG. 37  of the drawings causing the fluid contained within vial reservoir  351  to be urged outwardly thereof via fluid passageways  345   a  ( FIG. 34 ) and in the direction of the arrow  391  of  FIG. 37 . The ullage  351   a  functions to ensure that substantially all of the fluid contained within reservoir  351  will be expelled therefrom. 
         [0135]    The fluid flowing from vial reservoir  351  will flow past main check valve  368 , through the fluid passageways  370  in the direction of the arrows  391  and  373  and around and about an umbrella check valve  377  that is carried by check valve housing  344 . The fluid flowing around and about an umbrella check valve  377  in the direction of the arrows  373  of  FIG. 37  will then flow into fluid passageway  330  that is formed in dispenser housing portion  285   c  via a stub passageway  394   a.    
         [0136]    From passageway  330 , the fluid will flow into inlet passageway  328  and then into reservoir  295  of the container via the central passageway  303   a  of penetrating member  303 . During the adding process, any gases trapped within the flow passageways of the device are vented to atmosphere via a vent “V- 1 ” formed in connector portion  285   c  of control portion  285 . Following the completion of the adding process as described in the preceding paragraphs wherein the fluid medicament “F” contained within vial reservoir  351  is added to the reservoir  295 , the operating means is used to control the flow of the fluid mixture from the collapsible reservoir toward the rate control means and then onward toward the administration set. More particularly, to accomplish this fluid dispensing step, the indexing button  334  is once again pushed inwardly of cavity  335  to move the locking tab  334   a  out of engagement with the notch within which it resides and the control knob is rotated from the “ADD” position ( FIG. 21 ) to the “DISP” position. Release of the indexing button will then cause the outwardly biased locking tab  334   a  to move into engagement with an appropriate locking notch so as to lock the control knob in the “ADD” position. 
         [0137]    Further rotation of control knob  320 , will also cause penetrating member  303  to move further inwardly to the position illustrated in  FIG. 38 , wherein a stub passageway  400  formed in penetrating member  303  aligns with a fluid flow passageway  402  formed in control portion  285   a . With the penetrating member  303  in this advanced position fluid communication between the fluid reservoir  295  and the rate control means of the device is established via fluid flow passageway  303   a  of penetrating member  303 . 
         [0138]    To cause the fluid to flow from reservoir  295  toward the flow rate control means, the locking means of the invention must be manipulated in a manner to release the carriage assembly from base wall  286   b  of reservoir housing  286 . In this regard, as best seen in  FIGS. 7 ,  8 ,  10  and  38 , the carriage locking means includes a locking member  404  having a yieldably deformable locking tab  404   a  which extends through a strategically shaped opening  406  provided in the base wall  286   b  of reservoir housing (see  FIGS. 8 and 38 ). With this construction, an inward force exerted on the locking member will deform the locking tab  404  in a manner to permit it to pass through the opening  406  and in so doing release the carriage from the base wall  286   b . Release of the carriage will permit the stored energy means, or coiled spring  314 , to move the carriage from a position shown in  FIGS. 7 and 10  into the position shown in  FIG. 38 . 
         [0139]    As the accordion-like sidewall of the container collapses due to the urging of the coiled spring, the medicinal fluid mixture contained within the reservoir  295  will be controllably expelled therefrom and will flow toward the fluid passageway  303   a  of penetrating member  303 , which has now moved into the position shown in  FIG. 38  of the drawings. From the fluid passageway of penetrating member  303 , fluid will flow into a stub passageway  400  into passageway  402  and then into the inlet  409  of the fluid rate control means of the invention. 
         [0140]    The important fluid rate control means of the invention, which is illustrated in  FIGS. 40 and 41  of the drawings, comprises a rate control housing  410 , which includes a front cover  412  having the previously identified inlet  409  and an outlet  414 . Rate control housing  410  also includes a back cover  416  having an inlet  416   a  and an outlet  416   b . Disposed between the front and back cover is a novel rate control plate  420  having a uniquely configured, circuitous fluid flow channel  420   a  formed on the first surface  420   b  thereof and a substantially linear fluid flow channel  420   c  formed on the second surface  420   d  thereof ( FIGS. 42-44 ). 
         [0141]    With the construction described in the preceding paragraphs, as the sidewall of the fluid container collapses ( FIG. 38 ), fluid will flow from reservoir  295  into the flow passageway of penetrating member  303 , into stub passageway  400 , then into passageway  402  and then into the inlet passageway  409  of the rate control means. From passageway  409 , the fluid will flow into the front cover  412 , through the outlet  414  and then into inlet  421  of fluid flow channel  420   a . The fluid will then flow through the rate control channel, out the outlet  423  of the rate control channel and into the inlet  416   b  of back cover  416 , outwardly into substantially linear fluid flow channel  420   c  formed on the second surface  420   d  of rate control plate  420 , out through outlet  425  thereof, out through outlet  414  of back cover  416  and then into an elongated passageway  428  formed in the connector portion  285   c  of control portion  285 . From the elongated channel  428  the fluid will flow onward to the administration set  318  and then to the patient. It is apparent that by varying the geometry, including the length, width and depth of the flow control channels  420   a  and  420   c , the rate of fluid flow to the administration set and to the patient can be readily varied. During the fluid dispensing process, any gases trapped within the fluid delivery passageways of the device are vented to atmosphere via a vent “V- 2 ” formed in connector segment  285   b.    
         [0142]    As indicated in  FIG. 5 , administration set  318  is sealably connected to the control portion  285   a  by any suitable means so that the proximal end of the administration line  318   a  of the administration set is in communication with an outlet fluid passageway in communication with passageway  428 . Disposed between the proximal end and the distal end of the administration line is a conventional clamp  435 , a conventional gas vent and filter  437  and a conventional “Y” site  439 . Provided at the distal end of the administration line is a luer connector  441  of conventional construction. 
         [0143]    To accomplish residual drug recovery from reservoir  295  as may be required, recovery means are provided. In this regard, as best seen in  FIGS. 7 and 38  a stub passageway  444  formed in body  285   b  also communicates with fluid passageway  428 . Stub passageway  444  also communicates with a cavity  446  formed in body  285   b  ( FIG. 38 ). Sealably mounted within cavity  446  is a pierceable septum  448  which is pierceable by the needle of a conventional syringe that can be used to accomplish residual drug recovery from reservoir  295 . 
         [0144]    As illustrated in  FIGS. 5 and 8 , housing  286  is provided with a belt clip receiving member  452  to which a belt clip  454  can be slidably interconnected. When the belt clip  454  is connected with receiving member  452 , the device can be conveniently carried on the user&#39;s belt during the adding and medicament dispensing steps. 
         [0145]    Referring to  FIGS. 45 through 48 , an alternate form of the fluid dispensing device of the present invention for dispensing medicaments to a patient is there shown. This alternate form of dispensing device is similar in many respects to that shown in  FIGS. 5 through 44  and like numerals are used in  FIGS. 45 through 47  to identify like components. The major difference between this latest embodiment of the invention and that shown in  FIGS. 5 through 44  resides in the differently configured additive sub-system  458 . The dispenser unit  282  of this latest embodiment of the invention is substantially identical in construction and operation to that previously described and the additive sub-system  458  is connected to the dispenser unit in substantially the same manner. 
         [0146]    This important additive sub-system  458  here comprises a vial housing  460  having a chamber  460   a  for telescopically receiving the novel medicament containing, collapsible fill-vial  462 . Collapsible fill-vial  462 , rather than being of a bellows-type construction, here comprises a collapsible bottle-like construction. As before, dispenser reservoir  461  and medicament containing vial  462  can be of various volumes ranging from about 5 ml to about 50 ml. 
         [0147]    As shown in  FIG. 46 , vial housing  460  has a forward wall  460   b  that includes a generally cylindrical, forwardly extending portion  460   c  that is receivable within internal chamber  344   a  formed in check valve housing  344 . As before, check valve housing  344  has a forwardly extending portion  344   b  that is receivable within an internal chamber  285   c  formed in connector control portion  285   b . Mounted within internal chamber  344   a  of the check valve housing is a check valve actuator  345  the construction and operation of which is identical to that previously described. 
         [0148]    Formed in the lower surface  460   d  of connector housing  460  is a dovetail receiving groove  460   e  that mates with dovetail connector  286   c  in the manner previously described. Also forming a part of the additive sub-system  458  of this latest embodiment of the invention is a carriage assembly  346  which is substantially identical in construction and operation to that previously described and is movable between a first position shown in  FIG. 46  to a second position shown in  FIG. 47 . 
         [0149]    Carried by carriage assembly  346  is the previously identified bottle-like, collapsible fill-vial  462  that defines a fluid reservoir  461 . As indicated in  FIG. 46 , fill-vial  462  comprises a flange portion  463 , a closure wall  465  and a collapsible sidewall  467 . In the preferred form of the invention, the collapsible fill-vial  462  is blow-molded in a manner well understood by those skilled in the art. 
         [0150]    Flange portion  463  of the vial  462  is closely receivable within an annular groove  471  formed in forward wall  460   b  of connector housing  460 . As indicated in  FIGS. 46 and 47  of the drawings, the generally cylindrical portion  460   c  of the forward wall, which here comprises a main check valve housing, is provided with an internal chamber  464  that is in communication with the fluid reservoir  461  via an inlet port  476 . Connected to forward wall  460   b  and extending into fluid reservoir  461  is an ullage member  477 , the purpose of which will presently be described. 
         [0151]    In carrying out the reservoir-filling step, the additive sub-system  458  of this latest form of the invention is interconnected with the control portion  285  by mating the dovetail connector segment  286   c  of the dispenser unit with the groove formed in connector housing  460  and then sliding the additive sub-system forwardly into the position shown in  FIG. 46 . As before, this step causes the check valve  368  to be moved from the reservoir sealing configuration shown in  FIG. 45  to the configuration shown in  FIGS. 46 and 47  where fluid is permitted to flow from the reservoir of the fill-vial toward the umbrella check valve  377 . 
         [0152]    Following the mating of the additive sub-system  458  with the dispenser unit, the carriage lock  482 , which is carried within a slot  481  formed in end wall  460   e  of housing  460 , is manipulated in the manner previously described to release carriage  346 . More particularly, end wall  460   e  is provided with an opening  481  that is adapted to receive the hook-like locking protuberance  482  that is connected to and extends outwardly from base wall  346   b  of the carriage assembly  346 . Accordingly, when the carriage lock  380  is manipulated in the manner previously described the hook-like protuberance will be released in the manner shown in  FIG. 47 . 
         [0153]    Release of the hook-like protuberance  482  will permit the coiled spring  386 , which is carried within housing  460 , to urge the carriage assembly  346  forwardly of housing from the position shown in  FIG. 46  toward the position shown in  FIG. 47 . Forward movement of the carriage will be guided by the plurality of spaced-apart guide members  390  that are mounted within the housing  460  and are received within the circumferentially spaced slots  349   a  formed in carriage base  346   b . As the carriage moves forwardly the sidewall of the fluid containing vial  467  will collapse in the manner shown in  FIG. 47  of the drawings causing the fluid contained within vial reservoir  461  to be urged outwardly thereof via fluid passageway  476  ( FIG. 46 ) and in the direction of the umbrella valve  377 . As before, the ullage  477  functions to ensure that substantially all of the fluid contained within reservoir  461  will be expelled therefrom. 
         [0154]    The fluid flowing from vial reservoir  461  will flow past main check valve  368  and around and about the umbrella check valve  377 . The fluid will then flow into fluid passageway  330  that is formed in dispenser housing portion  285   b  via a stub passageway  394   a.    
         [0155]    From passageway  330 , the fluid will flow into inlet passageway  328  and then into reservoir  493  of the container via the central passageway  303   a  of penetrating member  303 . During the adding process, any gases trapped within the flow passageways of the device are vented to atmosphere via a vent “V- 1 ” formed in connector housing portion  285   b  of control portion  285 . Following the completion of the adding process as described in the preceding paragraphs, wherein the fluid medicament “F- 1 ” contained within vial reservoir  461  is added to the reservoir  493 , the operating means is used in the manner previously described to control the flow of the fluid mixture from the collapsible reservoir  493  toward the rate control means and then onward toward the administration set. 
         [0156]    Referring next to  FIGS. 49 through 55 , still another form of the fluid dispensing device of the present invention for dispensing medicaments to a patient is there shown. This latest form of dispensing device is similar in some respects to that shown in  FIGS. 45 through 48  and like numerals are used in  FIGS. 49 through 55  to identify like components. As before, this latest embodiment of the invention comprises two major cooperating components, namely a dispenser unit  490  and an additive sub-system  458 . Additive sub-system  458  is substantially identical in construction and operation to that previously described in connection with the embodiment illustrated in  FIGS. 45 through 48  and is connected to the dispenser unit in substantially the same manner. 
         [0157]    The major difference between this latest embodiment of the invention and that shown in  FIGS. 45 through 48  resides in the differently configured fluid container component  492  of the dispenser unit. This fluid container component, rather than being of a bellows-type construction, here comprises a collapsible bottle-like construction of the character best seen in  FIG. 53  of the drawings. 
         [0158]    As before, the reservoir  493  of the fluid container component  492  of the dispenser unit and medicament containing vial  462  of the additive sub-system can be of various volumes ranging from about 5 ml to about 50 ml. 
         [0159]    As illustrated in  FIG. 50 , the dispenser unit  490  is quite similar in construction to dispenser unit  282  and includes an outer housing  286 , which comprises a control portion  285  and a generally cylindrically shaped reservoir housing  286  that is interconnected with the control portion  285  in the manner best seen in  FIG. 51  of the drawings. 
         [0160]    Housed within reservoir housing  286  is the differently configured fluid container component  492 . As illustrated in  FIGS. 50 and 52 , the fluid container component  492  here comprises a bottle-like configuration having a top wall  492   a , collapsible side wall  492   b  and an interconnected base  492   c . Connected to top wall  492   a  is a neck portion  492   g  that is sealed by a closure wall  492   d  ( FIGS. 53 and 54 ). 
         [0161]    In the preferred form of the invention, reservoir defining assembly  492  is formed in accordance with an aseptic blow-fill technique of the character previously described. As before, reservoir defining assembly  492  is carried by a carriage assembly  288  which is of substantially identical construction and operation to that previously described. 
         [0162]    In carrying out the reservoir-filling step, the additive sub-system  458  of this latest form of the invention is interconnected with the control portion  285  by mating the dovetail connector segment  286   c  of the dispenser unit with the groove  460   c  formed in connector housing  460  and then sliding the additive sub-system forwardly into the position shown in  FIG. 51 . As before, this step causes the check valve  368  to be moved from the reservoir sealing configuration to the configuration shown in  FIG. 51  where fluid is permitted to flow from the reservoir of the fill-vial toward the umbrella check valve  377 . 
         [0163]    Following the mating of the additive sub-system  458  with the dispenser unit  490 , the carriage lock  380 , which is carried within a slot  460   s  formed in end wall  460   e  of housing  460 , is manipulated in the manner previously described to release carriage  348 . More particularly, end wall  460   e  is provided with an opening  481  that is adapted to receive the hook-like locking protuberance  382  that is connected to and extends outwardly from base wall  348   a  of the carriage assembly  346 . Accordingly, when the carriage lock  380  is manipulated in the manner previously described the hook-like protuberance will be released in the manner shown in  FIG. 55 . 
         [0164]    Release of the hook-like protuberance  382  will permit the coiled spring  386  to urge the carriage assembly  346  forwardly of housing from the position shown in  FIG. 51  toward the position shown in  FIG. 55 . Forward movement of the carriage will be guided by the plurality of spaced-apart guide members  390  that are mounted within the housing  460  and are received within the circumferentially spaced slots  349   a  formed in carriage base  348   a . As the carriage moves forwardly the sidewall of the fluid containing vial  462  will collapse in the manner shown in  FIG. 55  of the drawings causing the fluid contained within vial reservoir  461  to be urged outwardly thereof via fluid passageway  476  ( FIG. 55 ) and in the direction of the umbrella valve  377 . As before, the ullage  477  functions to ensure that substantially all of the fluid contained within reservoir  461  will be expelled therefrom. 
         [0165]    The fluid flowing from vial reservoir  461  will flow past main check valve  368  and around and about the umbrella check valve  377 . The fluid will then flow into fluid passageway  330  that is formed in dispenser housing portion  285   d  via a stub passageway  394   a.    
         [0166]    From passageway  330 , the fluid will flow into inlet passageway  328  and then into reservoir  493  of the container via the central passageway  303   a  of penetrating member  303 . During the adding process, any gases trapped within the flow passageways of the device are vented to atmosphere via a vent “V- 1 ” formed in connector housing portion  285   b  of control portion  285 . Following the completion of the adding process as described in the preceding paragraphs, wherein the fluid medicament “F- 1 ” contained within vial reservoir  461  is added to the reservoir  493 , the operating means is used in the manner previously described to control the flow of the fluid mixture from the collapsible reservoir  493  toward the rate control means and then onward toward the administration set. 
         [0167]    Referring next to  FIGS. 56 ,  57  and  58 , still another form of the dispensing device of the present invention for dispensing medicaments to a patient is there shown. This alternate form of dispensing apparatus is similar in many respects to that shown in  FIG. 51  and like numerals are used in  FIGS. 56 ,  57  and  58  to identify like components. The major difference between this latest embodiment of the invention and that shown in  FIG. 51  resides in the differently configured reservoir defining assembly. More particularly, the reservoir defining assembly  294  is substantially identical in construction and operation to that of the embodiment of the invention shown in  FIGS. 18 ,  19  and  20 . The additive sub-system  458  of this latest form of the invention is also substantially identical in construction and operation to that previously described and illustrated in  FIG. 49  and includes a medicament containing, fill-vial assembly  462 . 
         [0168]    As was described in connection with the embodiment of  FIGS. 18 ,  19  and  20 , reservoir-defining assembly  294  comprises a top wall  296 , a bottom wall  298  and an accordion-like sidewall  300 . Connected to top wall  296  is a neck portion  302  that is sealed by a closure wall  302   a  (see also  FIGS. 19 and 20 ). 
         [0169]    In carrying out the reservoir-filling step, the additive sub-system  458  of this latest form of the invention is interconnected with the control portion  285  of the dispenser by mating the dovetail connector segment  286   c  of the dispenser unit with the groove formed in connector housing  460  and then sliding the additive sub-system forwardly into the position shown in  FIG. 58 . As before, this step causes the check valve  368  to be moved from the reservoir sealing configuration to the configuration shown in  FIG. 58  where fluid is permitted to flow from the reservoir of the fill-vial toward the umbrella check valve  377 . 
         [0170]    Following the mating of the additive sub-system  458  with the dispenser unit, the carriage lock  380 , which is carried within a slot  460   s  formed in end wall  460   b  of housing  460 , is manipulated in the manner previously described to release carriage  346 . More particularly, end wall  460   b  is provided with an opening  481  that is adapted to receive the hook-like locking protuberance  482  that is connected to and extends outwardly from base wall  348   a  of the carriage assembly  346 . Accordingly, when the carriage lock  380  is manipulated in the manner previously described the hook-like protuberance will be released in the manner shown in  FIG. 58 . 
         [0171]    Release of the hook-like protuberance  482  will permit the coiled spring  386  to urge the carriage assembly  346  forwardly of housing from the position shown in  FIG. 56  the position shown in  FIG. 58 . Forward movement of the carriage will be guided by the plurality of spaced-apart guide members  390  that are mounted within the housing and are received within the circumferentially spaced slots  349   a  formed in carriage base  348   a . As the carriage moves forwardly the sidewall of the fluid containing vial assembly  462  will collapse in the manner shown in  FIG. 58  of the drawings causing the fluid contained within vial reservoir  461  to be urged outwardly thereof via fluid passageway  476  ( FIG. 55 ) and in the direction of the umbrella valve  377 . As before, the ullage  477  functions to ensure that substantially all of the fluid contained within reservoir  461  will be expelled therefrom. 
         [0172]    The fluid flowing from vial reservoir  461  will flow past main check valve  368  and around and about the umbrella check valve  377 . The fluid will then flow into fluid passageway  330  that is formed in dispenser housing portion  282  via a stub passageway  394   a.    
         [0173]    From passageway  330 , the fluid will flow into inlet passageway  328  and then into reservoir  493  of the container  492  via the central passageway  303   a  of penetrating member  303 . During the adding process, any gases trapped within the flow passageways of the device are vented to atmosphere via a vent “V- 1 ” formed in connector housing portion  285   b  of control portion  285 . Following the completion of the adding process as described in the preceding paragraphs, wherein the fluid medicament “F- 1 ” contained within vial reservoir  461  is added to the reservoir  295 , the operating means is used in the manner previously described to control the flow of the fluid mixture from the collapsible reservoir  295  toward the rate control means and then onward toward the administration set. 
         [0174]    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.