PATENT ABSTRACT
A fluid dispenser for use in controllably dispensing fluid medicaments, such as antibiotics, oncolytics, hormones, steroids, blood clotting agents, analgesics, bio-pharmaceuticals and like medicinal agents from a reservoir that has been filled from pre-filled containers. The fluid dispenser includes a housing to which fill-vials can be connected for filling the dispenser reservoir with the fluid, and a stored energy source provided in the form of a substantially constant-force spring that provides the force necessary to continuously and uniformly expel fluid from the device reservoir. The fluid dispenser also includes a fluid flow control assembly that precisely controls the flow of the medicament solution to the patient.

PATENT DESCRIPTION
[0001]     This is a Divisional Application of co-pending U.S. Ser. No. 10/634,625 filed Aug. 4, 2003. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     1. Field of the Invention  
         [0003]     The present invention relates generally to medicament infusion devices. More particularly, the invention concerns an improved apparatus for infusing medicinal agents into an ambulatory patient at specific rates over extended periods of time, which apparatus includes a novel constant force spring energy source, and a novel flow rate control means for precisely controlling the rate of fluid flow from the reservoir of the device.  
         [0004]     2. Discussion of the Prior Art  
         [0005]     A number of different types of medicament dispensers for dispensing medicaments to ambulatory patients have been suggested. 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.  
         [0006]     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 gravametric methods are cumbersome, imprecise and require bed confinement of the patient. Periodic monitoring of the apparatus by the nurse or doctor is required to detect malfunctions of the infusion apparatus.  
         [0007]     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 can result in a toxic reaction.  
         [0008]     For those patients that require frequent injections of the same or different amounts of medicament, the use of the hypodermic syringe method of delivery is common. However for each injection, it is necessary to first draw the injection dose into the syringe, then check the dose and, after making certain that all air has been expelled from the syringe, finally, inject the dose either under bolus or slow push protocol. This cumbersome and tedious procedure creates an unacceptable probability of debilitating complications, particularly for the elderly and the infirm.  
         [0009]     As will be appreciated from the discussion, which follows, the apparatus of the present invention is uniquely suited to provide precise fluid delivery management at a low cost in those cases where a variety of precise dosage schemes with infusion over time are of utmost importance. An important aspect of the apparatus of the present invention is the provision of novel fill means for filling the reservoir of the device using conventional medicament vials or cartridge containers of various types having a pierceable septum. Another unique feature of the apparatus of the present invention is the provision of various fluid flow rate control means, including an embedded micro-fluidic capillary flow rate control means which enables precise control of the rate of fluid flow of the medicament to the patient. More particularly, the apparatus of the present invention includes a unique, adjustable fluid flow rate mechanism, which enables the fluid contained within the reservoir of the device to be precisely dispensed at various selected rates over extended periods of time.  
         [0010]     The apparatus of the present invention can be used with minimal professional assistance in an alternate health care environment, such as the home. By way of example, devices of the invention can be comfortably and conveniently removably affixed to the patient&#39;s body or clothing and can be used for the continuous infusion of injectable anti-infectives, hormones, steroids, blood clotting agents, analgesics, and like medicinal agents. Similarly, the devices of the invention can be used for most IV chemotherapy and can accurately deliver fluids to the patient in precisely the correct quantities and at extended micro-fusion rates over time.  
         [0011]     By way of summary, the apparatus of the present invention uniquely overcomes the drawbacks of the prior art by providing a novel, disposable dispenser of simple but highly reliable construction. A particularly important aspect of the apparatus of the present invention resides in the provision of a novel, self-contained energy source in the form of a substantially constant-force spring that provides the force necessary to uniformly and precisely dispense, from the device reservoir, that is filled with various solutions from standard pre-filled vial containers that can be conveniently loaded into the apparatus. Because of the simplicity of construction of the apparatus of the invention, and the straightforward nature of the energy source, the apparatus can be manufactured at low cost without in any way sacrificing accuracy and reliability.  
         [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 the present inventor 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 the present applicant, 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 prefilled 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.  
         [0014]     Another important prior art fluid delivery device is described in the U.S. Pat. No. 6,063,059 also issued to the present inventor. This device, while being of a completely different construction, embodies a compressible-expandable stored energy source somewhat similar to that used in the apparatus of the present invention.  
         [0015]     Still another prior art fluid delivery device, in which the present inventor is also named as an inventor, is described in U.S. Pat. No. 6,086,561. This latter patent incorporates a fill system that makes use of conventional vials and cartridge medicament containers.  
       SUMMARY OF THE INVENTION  
       [0016]     It is an object of the present invention to provide a compact fluid dispenser for use in controllably dispensing fluid medicaments, such as, antibiotics, oncolytics, hormones, steroids, blood clotting agents, analgesics, bio-pharmaceuticals and like medicinal agents from a reservoir that has been filled from pre-filled containers.  
         [0017]     Another object of the invention is to provide a small, compact fluid dispenser that includes a housing to which fill-vials can be connected for filling the dispenser reservoir with the fluid.  
         [0018]     Another object of the invention is to provide a dispenser in which a stored energy source is provided in the form of a substantially constant-force spring that provides the force necessary to continuously and uniformly expel fluid from the device reservoir.  
         [0019]     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.  
         [0020]     Another object of the invention is to provide a dispenser that includes precise variable flow rate selection.  
         [0021]     Another object of the invention is to provide a dispenser that includes a disabling mechanism for disabling the device and rendering it inert following use.  
         [0022]     Another object of the invention is to provide a fluid dispenser which is adapted to be used at point of care being there filled with conventional pre-filled drug containers to deliver beneficial agents therefrom in a precise and sterile manner.  
         [0023]     Another object of the invention is to provide a fluid dispenser of the class described which is compact, lightweight, is easy for ambulatory patients to use, is fully disposable, and is extremely accurate so as to enable the infusion of precise doses of medicament over prescribed periods of time.  
         [0024]     Another object of the invention is to provide a device of the character described which embodies a novel fluid volume indicator that provides a readily discernible visual indication of the volume of fluid remaining in the device reservoir.  
         [0025]     Another object of the invention is to provide a self-contained medicament dispenser which is of very simple construction and yet extremely reliable in use.  
         [0026]     Another object of the invention is to provide a fluid dispenser as described in the preceding paragraphs which is easy and inexpensive to manufacture in large quantities.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0027]      FIG. 1  is a generally perspective view of one embodiment of the medicament infusion apparatus of the present invention for dispensing fluids at a uniform rate.  
         [0028]      FIG. 2  is a top plan view of the embodiment of the medicament infusion apparatus shown in  FIG. 1 .  
         [0029]      FIG. 3  is a bottom plan view of the apparatus 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 greatly enlarged, fragmentary, cross-sectional view of a portion of the bellows component of the apparatus shown in  FIG. 4 .  
         [0032]      FIG. 4B  is an enlarged, cross-sectional view of the area designated as  4 B in  FIG. 4 .  
         [0033]      FIGS. 4B-1  is an enlarged, cross-sectional view of the elastomeric band shown in  FIG. 4B .  
         [0034]      FIG. 4C  is an enlarged, cross-sectional view of the area designated as  4 C in  FIG. 4 .  
         [0035]      FIG. 4C-1  is an enlarged, cross-sectional view of the elastomeric band shown in  FIG. 4C .  
         [0036]      FIG. 5  is an enlarged, generally perspective view of one form of the constant force spring of the apparatus shown in  FIG. 4 .  
         [0037]      FIG. 6  is an enlarged, cross-sectional view of the area designated as “6” in  FIG. 5 .  
         [0038]      FIG. 7  is an enlarged, generally perspective view of an alternate form of the constant force spring of the apparatus of the invention.  
         [0039]      FIG. 8  is a cross-sectional view similar to  FIG. 4 , but showing the fluid reservoir filled with fluid.  
         [0040]      FIG. 8A  is an enlarged, cross-sectional view of the fill-vial of the apparatus of the invention shown in  FIG. 4 .  
         [0041]      FIG. 9  is a left end view of the apparatus shown in  FIG. 1 .  
         [0042]      FIG. 10  is a cross-sectional view taken along lines  10 - 10  of  FIG. 4 .  
         [0043]      FIG. 10A  is a cross-sectional view taken along lines  10 A- 10 A of  FIG. 10 .  
         [0044]      FIG. 11  is a right end view of the apparatus shown in  FIG. 1 .  
         [0045]      FIG. 12  is a cross-sectional view taken along lines  12 - 12  of  FIG. 4 .  
         [0046]      FIG. 13  is a cross-sectional view taken along lines  13 - 13  of  FIG. 4 .  
         [0047]      FIG. 14A and 14B  when considered together comprise a generally perspective, exploded view of the assembly shown in  FIG. 4 .  
         [0048]      FIG. 14B  is an end view of the snap together casing component shown in the lower left hand portion of  FIG. 14A .  
         [0049]      FIG. 14C  is a view taken along lines  14 C- 14 C of  FIG. 14 -B.  
         [0050]      FIG. 15  is a generally perspective, front view of one form of the fluid flow control assembly of the apparatus of the invention.  
         [0051]      FIG. 16  is a generally perspective, exploded front view of the fluid flow control assembly shown in  FIG. 15 .  
         [0052]      FIG. 17  is a greatly enlarged, fragmentary cross-sectional view of one of the flow control channels formed in the flow control member shown in the central portion of  FIG. 16 .  
         [0053]      FIG. 18  is a generally perspective, rear view of the fluid flow control assembly of the apparatus of the invention.  
         [0054]      FIG. 19  is a generally perspective, exploded rear view of the fluid flow control assembly shown in  FIG. 18 .  
         [0055]      FIG. 20  is a generally perspective view of an alternate form of the flow control member of the invention.  
         [0056]      FIG. 21  is a generally perspective view of still another form of the flow control member of the invention.  
         [0057]      FIG. 22  is a front view of the assembly shown in  FIG. 15 .  
         [0058]      FIG. 23  is a cross-sectional view taken along lines  23 - 23  of  FIG. 22 .  
         [0059]      FIG. 24  is a cross-sectional view taken along lines  24 - 24  of  FIG. 23 .  
         [0060]      FIG. 25  is a cross-sectional view taken along lines  25 - 25  of  FIG. 23 .  
         [0061]      FIG. 26  is a view taken along lines  26 - 26  of  FIG. 23 .  
         [0062]      FIG. 27  is a generally perspective view of an alternate embodiment of the medicament infusion apparatus of the present invention for dispensing fluids at a uniform rate.  
         [0063]      FIG. 28  is a top plan view of the embodiment of the medicament infusion apparatus shown in  FIG. 27 .  
         [0064]      FIG. 29  is a bottom plan view of the apparatus shown in  FIG. 27 .  
         [0065]      FIG. 30  is a cross-sectional view taken along lines  30 - 30  of  FIG. 29 .  
         [0066]      FIG. 30A  is an enlarged, cross-sectional view of the area designated as  30 A in  FIG. 30 .  
         [0067]      FIG. 30B  is an enlarged, cross-sectional view of the elastomeric seal shown in  FIG. 30 .  
         [0068]      FIG. 31  is a cross-sectional view similar to  FIG. 30 , but showing the fluid reservoir filled with fluid.  
         [0069]      FIG. 32  is a left end view of the apparatus shown in  FIG. 27 .  
         [0070]      FIG. 33  is a cross-sectional view taken along lines  33 - 33  of  FIG. 30 .  
         [0071]      FIG. 34  is a right end view of the apparatus shown in  FIG. 27 .  
         [0072]      FIG. 35  is a cross-sectional view taken along lines  35 - 35  of  FIG. 30 .  
         [0073]      FIG. 36  is a cross-sectional view taken along lines  36 - 36  of  FIG. 30 .  
         [0074]      FIG. 37  and  37 A when considered together comprise a generally perspective, exploded view of the assembly shown in  FIG. 30  (hereinafter collectively referred to as  FIG. 37 ).  
         [0075]      FIG. 37B  is an end view of the snap together housing component shown in the lower left hand portion of  FIG. 37A .  
         [0076]      FIG. 37C  is a view taken along lines  37 C- 37 C of  FIG. 37B .  
         [0077]      FIG. 38  is a generally perspective view of yet another embodiment of the medicament infusion apparatus of the present invention for dispensing fluids at a uniform rate.  
         [0078]      FIG. 39  is a top plan view of the embodiment of the medicament infusion apparatus shown in  FIG. 38 .  
         [0079]      FIG. 40  is a bottom plan view of the apparatus shown in  FIG. 38 .  
         [0080]      FIG. 41  is a cross-sectional view taken along lines  41 - 41  of  FIG. 40 .  
         [0081]      FIG. 41A  is an enlarged, cross-sectional view of the fill-vial cartridge of the apparatus of the invention shown in  FIG. 41   
         [0082]      FIG. 41B  is an enlarged, cross-sectional view of the area designated as  41 B in  FIG. 41 .  
         [0083]      FIG. 41C  is an enlarged, cross-sectional view of the area designated as  41 C in  FIG. 41 .  
         [0084]      FIG. 41D  is an enlarged, cross-sectional view of the elastomeric sealing band shown in  FIG. 41C .  
         [0085]      FIG. 42  is a cross-sectional view similar to  FIG. 41 , but showing the fluid reservoir filled with fluid.  
         [0086]      FIG. 43  is a left end view of the apparatus shown in  FIG. 38 .  
         [0087]      FIG. 44  is a cross-sectional view taken along lines  44 - 44  of  FIG. 41 .  
         [0088]      FIG. 45  is a right end view of the apparatus shown in  FIG. 38 .  
         [0089]      FIG. 46  is a cross-sectional view taken along lines  46 - 46  of  FIG. 41 .  
         [0090]      FIG. 47  is a cross-sectional view taken along lines  47 - 47  of  FIG. 41 .  
         [0091]      FIGS. 48 and 48 A when considered together comprise a generally perspective, exploded view of the assembly shown in  FIG. 41 (hereinafter collectively referred to as  FIG. 48 ).  
         [0092]      FIG. 48B  is an end view of the snap together housing component shown in the lower left hand portion of  FIG. 48A .  
         [0093]      FIG. 48C  is a view taken along lines  48 C- 48 C of  FIG. 48B .  
         [0094]      FIG. 49  is a generally perspective view of still another embodiment of the medicament infusion apparatus of the present invention for dispensing fluids at a uniform rate.  
         [0095]      FIG. 50  is a top plan view of the embodiment of the medicament infusion apparatus shown in  FIG. 49 .  
         [0096]      FIG. 51  is a bottom plan view of the apparatus shown in  FIG. 49 .  
         [0097]      FIG. 52  is a cross-sectional view taken along lines  52 - 52  of  FIG. 51 .  
         [0098]      FIG. 52A  is an enlarged, cross-sectional view of the area designated as  52 A in  FIG. 52 .  
         [0099]      FIG. 52B  is an enlarged, cross-sectional view of the area designated as  52 B in  FIG. 52 .  
         [0100]      FIG. 52C  is an enlarged, cross-sectional view of the elastomeric sealing band shown in  FIG. 52B .  
         [0101]      FIG. 53  is an enlarged cross-sectional view of the lowermost cartridge reconstitution vial of the apparatus of the invention shown in  FIG. 52 .  
         [0102]      FIG. 54  is a cross-sectional view taken along lines  54 - 54  of  FIG. 53 .  
         [0103]      FIG. 55  is an enlarged cross-sectional view of an alternate form of the lowermost cartridge fill by pass vial of the apparatus of the invention shown in  FIG. 52 .  
         [0104]      FIG. 56  is a cross-sectional view taken along lines  56 - 56  of  FIG. 55 .  
         [0105]      FIG. 57  is a cross-sectional view similar to  FIG. 52 , but showing the fluid reservoir filled with fluid.  
         [0106]      FIG. 58  is a left end view of the apparatus shown in  FIG. 49 .  
         [0107]      FIG. 59  is a cross-sectional view taken along lines  59 - 59  of  FIG. 52 .  
         [0108]      FIG. 60  is a right end view of the apparatus shown in  FIG. 49 .  
         [0109]      FIG. 61  is a cross-sectional view taken along lines  61 - 61  of  FIG. 52 .  
         [0110]      FIG. 62  is a cross-sectional view taken along lines  62 - 62  of  FIG. 52 .  
         [0111]      FIG. 63  and  63 A when considered together comprise a generally perspective, exploded view of the assembly shown in  FIG. 52  (hereinafter collectively referred to as  FIG. 63 ).  
         [0112]      FIG. 63B  is an end view of the snap together housing component shown in the lower left hand portion of  FIG. 63A .  
         [0113]      FIG. 63B  is a view taken along lines  63 B- 63 B of  FIG. 63B .  
         [0114]      FIG. 64  is a generally perspective view of still another embodiment of the medicament infusion apparatus of the present invention for dispensing fluids at a uniform rate.  
         [0115]      FIG. 65  is a top plan view of the embodiment of the medicament infusion apparatus shown in  FIG. 64 .  
         [0116]      FIG. 66  is a bottom plan view of the apparatus shown in  FIG. 64 .  
         [0117]      FIG. 67  is a longitudinal, cross-sectional view of the apparatus shown in  FIG. 64 .  
         [0118]      FIG. 67A  is an enlarged, cross-sectional view of the area designated as  67 A in  FIG. 67 .  
         [0119]      FIG. 68  is a cross-sectional view taken along lines  68 - 68  of  FIG. 67 .  
         [0120]      FIG. 69  is a cross-sectional view similar to  FIG. 67 , but showing the fluid reservoir filled with fluid.  
         [0121]      FIG. 70  is a cross-sectional view taken along lines  70 - 70  of  FIG. 67 .  
         [0122]      FIG. 71  is a left end view of the apparatus shown in  FIG. 64 .  
         [0123]      FIG. 72  is a right end view of the apparatus shown in  FIG. 64 .  
         [0124]      FIG. 73  is a cross-sectional view taken along lines  73 - 73  of  FIG. 67 .  
         [0125]      FIG. 74  is a cross-sectional view taken along lines  74 - 74  of  FIG. 67 .  
         [0126]      FIG. 75  and  75 C when considered together comprise a generally perspective, exploded view of the assembly shown in  FIG. 67  (hereinafter collectively referred to as  FIG. 75 ).  
         [0127]      FIG. 75A  is a view taken along lines  75 A- 75 A of  FIG. 75C .  
         [0128]      FIG. 75B  is a view taken along lines  75 - 75 B of  FIG. 75A .  
         [0129]      FIG. 76  is a generally perspective, exploded view of the flow rate control means of this latest form of the apparatus of the present invention.  
         [0130]      FIG. 77  is a generally perspective, front exploded view of the flow rate control means shown in  FIG. 76 .  
         [0131]      FIG. 78  is a front view of the forward most rate control plate of the flow control means shown in  FIG. 78 .  
         [0132]      FIG. 79  is a cross-sectional view taken along lines  79 - 79  of  FIG. 78 .  
         [0133]     FIGS.  80  and  FIG. 80A , when considered together comprise an exploded, generally perspective view of the rate control plates of the rate control assembly of the invention.  
         [0134]      FIG. 81 , when considered in its entirety, comprises a front view of each of the rate control plates of the assembly shown in  FIGS. 80 and 80 A.  
         [0135]      FIG. 82  is a view taken along lines  82 - 82  of  FIG. 80 .  
         [0136]      FIG. 82A  is a rear view of the inlet manifold component.  
         [0137]      FIG. 82B  is a cross-sectional view taken along lines  82 B- 82 B of  FIG. 82A .  
         [0138]      FIG. 83  is a view taken along lines  83 - 83  of  FIG. 80 .  
         [0139]      FIG. 83A  is a side-elevational view of the rate control assembly shown in  FIG. 77  as it appears in a sealably interconnected configuration.  
         [0140]      FIG. 84  is a front view of the assembly shown in  FIG. 83 .  
         [0141]      FIG. 84A  is a cross-sectional view taken along lines  84 A- 84 A of  FIG. 84 .  
         [0142]      FIG. 85  is a rear view of the outlet manifold component of the assembly shown in  FIG. 83 .  
         [0143]      FIG. 85A  is a cross-sectional view taken along lines  85 A- 85 A of  FIG. 85 .  
         [0144]      FIG. 86  is a generally perspective, partially exploded view similar to  FIG. 83 .  
         [0145]      FIG. 86A  is a front view of the outlet manifold portion of the assembly shown in  FIG. 86 .  
         [0146]      FIG. 87  is a rear view of the first from the left, rate control plate of the assembly shown in  FIG. 80 .  
         [0147]      FIG. 88  is a front view of the rate control plate shown in  FIG. 87 .  
         [0148]      FIG. 89  is a cross-sectional view taken along lines  89 - 89  of  FIG. 88 .  
         [0149]      FIG. 90  is a rear view of the second from the left, rate control plate shown in  FIG. 80 .  
         [0150]      FIG. 91  is a front view of the rate control plate shown in  FIG. 90 .  
         [0151]      FIG. 92  is a cross-sectional view taken along lines  92 - 92  of  FIG. 91 .  
         [0152]      FIG. 93  is a fragmentary, cross-sectional view of the forward portion of the outlet manifold of the flow control means shown sealably mated with the rate control knob of the apparatus of the invention.  
         [0153]      FIG. 93A  is an enlarged, fragmentary, cross-sectional view of the upper portion of  FIG. 93 .  
         [0154]      FIG. 93B  is an enlarged, fragmentary, cross-sectional view of the lower portion of  FIG. 93 .  
         [0155]      FIG. 93C  is an enlarged, cross-sectional view of one of the elastomeric sealing bands shown in  FIG. 93A .  
         [0156]      FIG. 93D  is an enlarged, cross-sectional view of the other elastomeric sealing bands shown in  FIG. 93A .  
         [0157]      FIG. 94  is a cross-sectional view taken along lines  94 - 94  of  FIG. 93 .  
         [0158]      FIG. 95  is a cross-sectional view similar to  FIG. 94 , but showing the rate control knob rotated to second rate control position.  
         [0159]      FIG. 96  is a generally perspective view of yet another embodiment of the medicament infusion apparatus of the present invention for dispensing fluids at a uniform rate.  
         [0160]      FIG. 97  is a top plan view of the embodiment of the medicament infusion apparatus shown in  FIG. 96 .  
         [0161]      FIG. 98  is a bottom plan view of the apparatus shown in  FIG. 97 .  
         [0162]      FIG. 99  is a longitudinal, cross-sectional view of the apparatus shown in  FIG. 96 .  
         [0163]      FIG. 99A  is an enlarged, cross-sectional view of the area designated as  99 A in  FIG. 99 .  
         [0164]      FIG. 99B  is an enlarged, cross-sectional view of the area designated as  99 B in  FIG. 99 .  
         [0165]      FIG. 100  is a cross-sectional view taken along lines  100 - 100  of  FIG. 99 .  
         [0166]      FIG. 100A  is a generally perspective front view of the flow control assembly of the form of the invention shown in  FIG. 100 .  
         [0167]      FIG. 100B  is a generally perspective rear view of the flow control assembly.  
         [0168]      FIG. 100C  is a longitudinal, cross-sectional view of the flow control assembly.  
         [0169]      FIG. 100D  is a generally perspective, exploded view of the flow control assembly.  
         [0170]      FIG. 101  is a cross-sectional view similar to  FIG. 99 , but showing the fluid reservoir filled with fluid.  
         [0171]      FIG. 102  is a cross-sectional view taken along lines  102 - 102  of  FIG. 99 .  
         [0172]      FIG. 103  is a left-end view of the apparatus shown in  FIG. 96 .  
         [0173]      FIG. 104  is a right-end view of the apparatus shown in  FIG. 96 .  
         [0174]      FIG. 105  is a cross-sectional view taken along lines  105 - 105  of  FIG. 99 .  
         [0175]      FIG. 106  and  106 B, when considered together, comprise a generally perspective, exploded view of the assembly shown in  FIG. 99  (hereinafter collectively referred to as  FIG. 106 ).  
         [0176]      FIG. 106C  is an end view of one of the snap together housing components shown in the lower left hand portion of  FIG. 100B .  
         [0177]      FIG. 106A  is a view taken along lines  106 A of  FIG. 106 .  
         [0178]      FIG. 107  is a generally perspective view of still another embodiment of the medicament infusion apparatus of the present invention for dispensing fluids at a uniform rate.  
         [0179]      FIG. 107A  is a generally perspective, exploded view of the embodiment of the apparatus shown in  FIG. 107 .  
         [0180]      FIG. 108  is a longitudinal, cross-sectional view of the apparatus shown in  FIG. 107 .  
         [0181]      FIG. 108A  is an enlarged, cross-sectional view of the area designated as  108 A of  FIG. 108 .  
         [0182]      FIG. 108B  is an enlarged, cross-sectional view of the area designated as  108 B in  FIG. 108 .  
         [0183]      FIG. 108C  is an enlarged, cross-sectional view of the area designated as  108 C in  FIG. 108 .  
         [0184]      FIG. 109  is a left-end view of the apparatus shown in  FIG. 107 .  
         [0185]      FIG. 110  is a cross-sectional view taken along lines  110 - 110  of  FIG. 108 .  
         [0186]      FIG. 110A  is a view taken along lines  110 A- 110 A of  FIG. 110 .  
         [0187]      FIG. 111  is a side elevational view of the vial cover portion of the apparatus shown in  FIG. 108 .  
         [0188]      FIG. 112  is a view taken along lines  112 - 112  of  FIG. 111 .  
         [0189]      FIG. 113  is an enlarged, cross-sectional view of the upper fill-vial of the apparatus of the invention shown in  FIG. 108 .  
         [0190]      FIG. 114  is a view taken along lines  114 - 114  of  FIG. 113 .  
         [0191]      FIG. 115  is an enlarged, cross-sectional view of the lowermost cartridge fill-vial of the apparatus of the invention shown in  FIG. 108 .  
         [0192]      FIG. 116  is a view taken along lines  116 - 116  of  FIG. 115 .  
         [0193]      FIG. 117  is an enlarged, cross-sectional view of an alternate form of the lowermost cartridge fill-vial of the apparatus of the invention shown in  FIG. 108 .  
         [0194]      FIG. 118  is a view taken along lines  118 - 118  of  FIG. 117 . 
     
    
     DESCRIPTION OF THE INVENTION  
       [0195]     Referring to the drawings and particularly to  FIGS. 1 through 14 , one embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral  52 . The apparatus here comprises a snap and bond moldable plastic outer housing  54  having a first, second and third portions  54   a,    54   b  and  54   c  respectively. Disposed within outer housing  54  is a first, expandable housing  56  having a fluid reservoir  58  ( FIGS. 4 and 8 ) that is provided with an inlet passageway  60  for permitting fluid flow into the fluid reservoir and an outlet  64  for permitting fluid flow from the fluid reservoir. Expandable housing  56 , which can be constructed from a metal or plastic material and can include a surface treatment and coating of the character presently to be described, comprises a bellows structure having an expandable and compressible, accordion-like, annular-shaped sidewall  56   a,  the configuration of which is best seen in  FIGS. 4 and 8 .  
         [0196]     Disposed within second portion  54   b  of outer housing  54  is the novel stored energy means of the invention for acting upon inner expandable housing  56  in a manner to cause the fluid contained within fluid reservoir  58  to controllably flow outwardly of the housing. In the present form of the invention, this important stored energy means comprises a constant force extension spring member  67  that is carried within cavities or wells  54   a  formed in the second portion  54   b  of the outer housing (see  FIG. 14 ).  
         [0197]     Spring member  67  is first extended in the manner shown in  FIG. 8  by fluid flowing into reservoir  58  and then controllably retracts in the manner shown in  FIG. 4  to cause fluid flow from the outer housing through the dispensing means of the invention. Stored energy member or constant-force, double-spool, single-layer spring  67 , which is a special variety of extension spring, is readily commercially available from several sources, including Barnes Group Inc. of Bristol, Conn.; Stock Drive Products/Sterling Instrument of Hyde Park, N.Y. and Walker Corporation of Ontario, Calif. Constant force extension spring  67  is basically a high stress, long deflection device that offers great advantages when used in applications, such as the present application, where very low or zero gradient is desired, where space is a factor and where very high reliability, accuracy, and forced tolerance is required. Constant force springs, such as spring  67 , provides markedly superior constant force loading when compared to conventional helical extension or like conventional types of springs. A constant force spring is typically a roll of pre-stressed, strip of metal that exerts a nearly constant restraining force to resist uncoiling. The force is constant because the change in the radius of the curvature is constant. Spring  67  can be of a laminate construction, such as shown in  FIGS. 5 and 6 , and identified as  67   a  wherein the laminate construction acts on a pusher member  69  of the character shown in  FIG. 4 . Alternatively spring  67  can comprise a pair of cooperatively associated, individual extension springs  67   a  and  67   b  of the character shown in  FIG. 7  which have free-end portions  67   c  that are receivable within spring receiving slots  71  formed in a specially constructed pusher member  73 . Springs  67 ,  67   a  and  67   b  can be constructed from a wide variety of materials including stainless steel and are held in position by opposing positioning means or cross members  67   d  which are of the construction shown in  FIGS. 10 and 10 A.  
         [0198]     After the springs are extended in the manner shown by the phantom lines in  FIG. 4  and by the solid lines in  FIG. 8 , the springs will inherently tend to uniformly return toward their starting configuration and in so doing will exert a substantially constant force (force over extension or extension over time) on the pusher member  69  which is operably coupled with the expandable housing  56  in the manner shown in  FIGS. 4 and 8 . As the springs return to their starting configuration, the fluid contained within the fluid reservoir  58  will be caused to flow outwardly through outlet  64  at a substantially constant rate.  
         [0199]     Forming an important aspect of the apparatus of the present invention is fill means carried by the third portion  54   c  of outer housing  54  for filling the reservoir  58  with the fluid to be dispensed. As best seen in  FIG. 4 , third portion  54   c  of the outer housing includes a fluid passageway  78  that is in communication with inlet  60  of fluid reservoir  58 . Proximate its lower end  78   a,  fluid passageway  78  communicates with a cavity  80  formed within the third portion  54   c  of the housing. Disposed within cavity  80  is a pierceable septum  84  that comprises a part of one form of the fill means of this latest form of the invention. Septum  84 , which is of conventional construction, is held in position by a retainer  84   a  and is pierceable by the needle of the syringe which contains the medicinal fluid to be dispensed and which can be used in a conventional manner to fill or partially fill reservoir  58  via passageway  78 . Septum  84  can also be used to accomplish residual drug recovery from reservoir  58 .  
         [0200]     Third portion  54   c  of housing  54  also includes a chamber  85  for telescopically receiving a medicament containing shell fill-vial  88 . An elongated support  90 , which is disposed within chamber  85 , includes a threaded end portion  92  and carries a longitudinally extending, elongated hollow needle  94  having a flow passageway that communicates with fluid passageway  78  via a stub passageway  97 . Chamber  85 , elongated support  90  and hollow needle  94  together comprise an alternate form of fill means of the apparatus of the invention. The method of operation of this alternate form of fill means will presently be described.  
         [0201]     Referring particularly to  FIG. 8A , the medicament containing fill-vial  88  includes a body portion  88   a,  having a fluid chamber  100  for containing the injectable fluid medicament “F”. Chamber  100  is provided with a first open end  100   a  and second closed end  100   b.  First open end  100   a  is sealably closed by closure means here provided in the form of an externally threaded elastomeric plunger  102 , which is telescopically movable within the vial from a first location, where the plunger is disposed proximate first open end  100   a  to a second, device-fill location where the plunger is disposed proximate second closed end  100   b.    
         [0202]     After removal of the vial chamber cover  103 , which forms a part of the third portion  54   c  of the snap and bond together housing  52  ( FIGS. 4 and 14 ), vial  88  can be inserted into chamber  85 . As the fill-vial is so introduced and the plunger  102  is threadably interconnected with end  92  of support  90  ( FIG. 4 ), the sharp end of the elongated needle  94  will pierce the central wall  102   a  of the elastomeric plunger. Continuous pushing movement of the vial into chamber  85  will cause the structural support  90  to move the elastomeric plunger inwardly of the vial chamber  100  in a direction toward the second, or closed, end  100   b  of the vial chamber. As the plunger is moved inwardly of the vial, the fluid “F” contained within the vial chamber will be expelled therefrom into the hollow elongated needle  94 . As best seen in  FIG. 4 , the fluid will then flow past a conventional elastomeric umbrella-type check valve  106 , which is mounted within a cavity  107  formed in lower portion  54   c  of the outer housing. Next, the fluid will flow into stub passageway  97  and thence into passageway  78 . Umbrella-type check valve  106  functions in a conventional manner to control fluid flow from the elongated hollow needle  94  toward fluid passageway  78 . From passageway  78 , the fluid will flow into inlet passageway  60  and then into reservoir  58  of the bellows component  56 .  
         [0203]     As the fluid flows from either of the fill means of the invention into the bellows reservoir  58 , the bellows will expand from the collapsed configuration shown in  FIG. 4  into the expanded configuration shown in  FIG. 8 . As best seen in  FIG. 4A , the inner wall of the bellows is provided with one or more protective coatings “C” that are compatible with the fluids contained within reservoir  58 . This coating can be accomplished by several different processes. One process that is extremely clean, fast and effective is plasma processing. In particular this technique allows for any of the following: plasma activation, plasma induced grafting and plasma polymerization of molecular entities on the surface of the bellows. For cases where an inert hydrophobic interface is desired, plasma-using fluorine-containing molecules may be employed. In this regard, the bellows surface may be cleaned with an inert gas plasma, and subsequently, a fluorine-containing plasma may be used to graft these molecules to the surface. Alternatively, if a hydrophilic surface is desired (e.g. for drug solutions that are highly corrosive or in oil-based solvents) an initial plasma cleaning may be done, followed by a plasma polymerization using hydrophilic monomers.  
         [0204]     As the bellows member expands it will urge a telescopically movable volume indicator member  110 , which is carried within a second portion  54   b  of the housing and which is interconnected with pusher member  69 , rearwardly of the apparatus housing in the manner shown in  FIG. 8 . Pusher member  69  is stabilized by controller struts  69   a  which are located on the housing of body half shells  54   c.  The forces thus exerted on the spring member  67  by the rearwardly moving pusher member  69  will cause the spring member  67  to expand from its retracted configuration shown in  FIG. 4  into the expanded configuration shown in  FIG. 8 . As the reservoir  58  fills with fluid, any gases trapped within the reservoir will be vented to atmosphere via vent means “V” mounted in portion  54   a  of the housing. This vent means here comprises a gas vent  113  ( FIG. 8 ) that can be constructed of a suitable hydrophobic porous material such as a porous plastic.  
         [0205]     Upon opening the fluid delivery path to the fluid delivery means of the invention, shown here as a conventional administration set  114  ( FIG. 1 ), the stored energy means, or spring  67 , will tend to return to its starting configuration thereby controllably urging fluid flow outwardly of reservoir  58  via the flow control means of the invention the character of which will presently be described.  
         [0206]     Administration set  114  is sealably connected to the first portion  54   a  of housing  54  by a connector  114   a  in the manner shown in  FIG. 1  of the drawings. As illustrated in  FIGS. 1 and 4 , the proximal end  116 a of administration line  116  of the administration set is in communication with an outlet fluid passageway  118  which is formed in portion  54   a  of the outer housing. Disposed between the proximal end  116   a  and the distal end  116   b  of the administration line are a conventional clamp  117 , a conventional gas vent and a conventional filter  113 . Provided at the distal end  116   b  of the administration line is a luer connector  122  and luer cap  122   a  of conventional construction ( FIG. 1 ).  
         [0207]     A number of beneficial agents can be contained within shell vial  88  and can be controllably dispensed from the fluid dispenser to the patient including, by way of example, medicaments of various types, drugs, pharmaceuticals, hormones, antibodies, biologically active materials, elements, chemical compounds, or any other suitable material useful in diagnostic cure, medication, treatment or preventing of diseases or the maintenance of the good health of the patient.  
         [0208]     As the fluid contained within the bellows reservoir  58  is urged outwardly thereof by the stored energy means, the fluid will flow under pressure through a filter means, shown here as a filter  124  that is carried in a cavity provided in a generally cylindrically shaped flow rate control member  126  ( FIG. 19 ). Flow rate control member  126  forms a part of the flow control means, or flow control assembly  129  of the invention. As will be better understood from the discussion which follows, this important flow control means functions to precisely control the rate of fluid flow outwardly from reservoir  58  and toward the patient via the administration set.  
         [0209]     Peripherally bonded filter  124 , which functions to filter particulate matter from the fluid flowing outwardly from reservoir  58  is of a character well known to those skilled in the art and can be constructed from various readily available materials such as polysolfone and polypropylene wafers having a desired porosity. After flowing through filter  124 , the fluid will flow via a stub passageway  125  ( FIG. 4 ) into the fluid flow distribution means of flow rate control member  126 , which functions, in a manner presently to be described, to distribute the fluid into the flow control channels strategically formed in member  126 .  
         [0210]     Referring particularly to  FIGS. 15 through 26 , it can be seen that flow control assembly  129  comprises an outer casing  130  having a plurality of circumferentially spaced-apart fluid outlets  132 , a flow rate control member  126 , which is telescopically receivable within casing  130  and a selector knob  134  that is interconnected with rate control member  126  in the manner best seen in  FIGS. 15, 16 ,  18 ,  19  and  23 . A compressibly deformable elastomeric band  131  sealably interconnects casing  130  with the housing portion  54   a  in the manner shown in  FIGS. 4B and 4C . As illustrated in the drawings, flow rate control member  126  is uniquely provided with a plurality of elongated flow control channels  128 , each having an inlet  128   b  and an outlet  128   a.  The flow channels  128  may be of different sizes, lengths, depths, widths and configurations as shown by  FIGS. 20 and 21 , which depict alternate forms of the flow control member. These alternate forms of flow control members with alternate micro-channel configurations, which are identified in the drawings as  126   a  and  126   b,  have uniquely configured flow control channels  128   c.  As used herein, the term “micro-channel” is interchangeable with the term “mini-channel”. As illustrated in  FIG. 17 , the flow control channels may be rectangular in cross-section. Alternatively, the flow control channels can be semicircular in cross-section, U-shaped in cross-section, or they may have any other cross-sectional configuration that may be appropriate to achieve the desired fluid flow characteristics. As previously discussed, where appropriate, channels  128  can be coated with one or more special coating “C” with appropriate surface modification in the manner shown in  FIG. 17 .  
         [0211]     When the flow control member is properly positioned and appropriately registered within outer casing  130 , the inner surface of the outer casing wall sealably cooperates with the flow control member channels  128  to form a plurality of generally spiral-shaped fluid flow passageways of different overall lengths and flow capacities. When the flow control member is positioned within the outer casing, a notch  138  formed in member  126  receives a tongue  140  provided on casing  130  to precisely align the outlets  128   a  of the flow channels  128  with fluid outlets  132  formed in casing  130 .  
         [0212]     Selector knob  134 , which comprises a part of the selector means of the invention, is rotatably connected to portion  54   a  of the outer housing and, in a manner presently to be described, functions to rotate the assemblage made up of outer casing  130  and flow control member  126  ( FIGS. 4 and 14 ). In this way, a selected outlet  132  in casing  130  can be selectively aligned with flow passageway  118  provided in portion  54   a  ( FIG. 4 ).  
         [0213]     As previously discussed herein, as the fluid contained within the bellows reservoir  58  is urged outwardly thereof by the stored energy means, the fluid will flow under pressure through filter  124 , into stub passageway  125  and then into the distribution means of the invention which functions to distribute fluid from the fluid reservoir to each of the plurality of spiral passageways  128  via passageway  142 . This distribution means here comprises several radially outwardly extending flow passageways  142  formed in flow control member  126  ( FIG. 25 ). The filtered fluid will fill passageways  142  and then will flow into the plurality of spiral passageways  128  formed in member  126  via outlets  128   b,  which communicate with passageways  142  (see  FIG. 25 ). The fluid contained within spiral passageways  128  can flow outwardly of the device only when one of the fluid outlets  132  formed in casing  130  is aligned with reservoir outlet passageway  118  ( FIGS. 8, 18  and  20 ).  
         [0214]     Selection of the passageway from which the fluid is to be dispensed is accomplished by rotation of the selector knob  134  which, as best seen in  FIG. 19  includes a reduced-diameter portion  134   a  having a slot  134   b  formed therein. As illustrated in  FIGS. 16 and 19 , slot  134   b  is adapted to receive a spline  146  formed anteriorly of member  126 . With this construction, rotation of selector knob  134  will impart part rotation to member  126 . As seen in  FIG. 19 , inwardly extending spline segment  140  is received within slot  138  formed in member  126 . Accordingly, rotation of member  126  will also impart concomitant rotation to casing member  130 .  
         [0215]     As shown in  FIGS. 18 and 19 , selector knob  134  is provided with a plurality of circumferentially spaced-apart indexing cavities  147  that closely receive an indexing finger  150 , which forms a part of the indexing means of the invention, which means comprises a front bezel  152  that is connected to the apparatus housing (see  FIGS. 4 and 14 ). Indexing finger  150  is continuously urged into engagement with a selected one of the indexing cavities  147  by a coil spring  154  that also forms a part of the indexing means of the invention. Coil spring  154  can be compressed by an inward force exerted on an indexing shaft  156  and button  156   a  that is mounted in locking shaft cover  152  and is movable from an extended position to an inward, finger release position wherein spring  154  is compressed and finger  150  is retracted from a selected indexing cavity  147 . With finger  150  in its retracted position, it is apparent that control knob  134  can be freely rotated to a position wherein a gripping member  157  can be aligned with selected flow rate indicia  159  formed on the front bezel  152  of the apparatus housing. The indicia may be symbols as shown in  FIG. 1  or it may be numbers as shown in  FIG. 11 .  
         [0216]     When the selector knob is in the desired position and pressure is released on indexing button  156   a,  spring  154  will urge finger  150  of the indexing means of the invention into locking engagement with one of the indexing cavities  147  thereby placing a selected one of the spiral-shaped flow control channels  128  that corresponds with the indicia  159  in communication with the fluid reservoir  58  via passageways  125  and  124 . As the fluid flows outwardly of the apparatus due to the urging of the stored energy means or spring member  67 , the bellows structure  56  will be collapsed and at the same time pusher member  69  will travel inwardly of the housing. Member  69 , which forms a part of the volume indicator means of the invention is guided by integral internal wall structure  69   a  of portion  54   c  and includes a radially outwardly extending indicating finger  110  that is visible through a volume indicator window  160  that is provided in a second portion  54   b  of the apparatus housing and also comprises a part of the volume indicator means of the invention ( FIGS. 1, 2 ,  10  and  14 ). Indicia  161 , which are provided on indicator window  160  ( FIGS. 2 and 14 ), function to readily indicate to the caregiver the amount of fluid remaining within fluid reservoir  58  at any point in time.  
         [0217]     Referring to  FIGS. 11 and 12 , disabling means, shown here as a disabling shaft  164  that is telescopically movable within a passageway  166  formed within housing portion  54   a  functions to irrevocably disable the device and render it inert. More particularly, shaft  164  has a distal end  164   a,  which, upon insertion of the shaft distal end  164   a  into bore  164   c  ( FIG. 12 ), will block fluid flow through passageway  118 . A friction-fit retainer  164   b  normally holds shaft  164  in the retracted position ( FIGS. 12 and 14 ). As shown in  FIG. 8 , a receptacle bore  164   c  is provided for receipt of shaft  164 .  
         [0218]     Referring now to  FIGS. 27 through 37 , another embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral  172 . This alternate form of the apparatus of the invention is similar in many respects to that shown in  FIGS. 1 through 26  and like numerals are used in  FIGS. 27 through 37  to identify like components. The primary differences between this latest form of the invention and that shown in  FIGS. 1 through 26  concern the provision of a differently configured internal housing and the provision of a different reservoir fill means for filling the device reservoir. More particularly, as will presently be described in greater detail, this alternate form of fill means comprises two specially designed fill-vials or containers.  
         [0219]     As best seen in  FIG. 27 , the apparatus here comprises an outer housing  174  having a first, second and third portions  176 ,  178  and  180  respectively. Disposed within outer housing  174  is an inner, expandable housing  56  which is identical in construction and operation to that described in connection with the embodiment of  FIGS. 1 through 26 .  
         [0220]     Disposed within second portion  178  of outer housing  174  is the novel stored energy means of the invention for acting upon inner expandable housing  56  in a manner to cause the fluid contained within fluid reservoir  58  thereof to controllably flow outwardly of the housing. In this latest form of the invention, this stored energy means is also identical in construction and operation to that previously described and comprises a constant force spring  67 .  
         [0221]     With regard to the fill means of this latest form of the invention, which is carried by the third portion  180  of the outer housing, this important fill means once again functions to fill the reservoir  58  with the fluid to be dispensed. This fill means here comprises the previously described septum-fill and recovery means, which is identical to that previously described, and also includes a vial-fill means which includes two, rather than the one, shell fill-vials or fill containers.  
         [0222]     With respect to the septum-fill means, as illustrated in  FIGS. 30 and 35 , third portion  180  of the outer housing here includes a fluid passageway  182  which is in communication with inlet  60  of fluid reservoir  58 . Proximate its lower end  182 a, fluid passageway  182  communicates with a cavity  184  formed within the third portion  180  of the housing. Disposed within cavity  184  is a pierceable septum  84  that comprises a part of the septum-fill means of this latest form of the invention. As before, septum  84 , which can be a slit septum, is held in position by a retainer  84   a  and is pierceable by the cannula of the syringe which contains the medicinal fluid to be dispensed and which can be used in a conventional manner to fill or partially fill reservoir  58  via passageway  182 .  
         [0223]     As best seen in  FIG. 30 , third portion  180  of the housing also includes a first chamber  186  for telescopically receiving a first medicament containing fill-vial  188  and a second chamber  190  for telescopically receiving a second medicament containing vial  192 . Fill-vials  188  and  192 , which are of identical construction, each cooperates with an elongated support  194  that is disposed within fluid chambers  196  of the vials. Each of the elongated supports has an integrally threaded end portion  194   a  and carries a longitudinally extending, elongated hollow needle  198 . Each of the hollow needles  198  has a flow passageway that communicates with fluid passageway  182  via the umbrella check valves and stub passageway  204 . First chamber  186 , second chamber  190 , elongated supports  194 , and hollow needles  198  together comprise the alternate form of the vial-fill means of the apparatus of the invention. The method of operation of this alternate form of fill means will presently be described.  
         [0224]     Forming another very important aspect of the apparatus of this latest form of the invention is a novel flow control means that is connected to first portion  176  of outer housing  174 . This flow control means, which is identical in construction and operation to that described in connection with the first embodiment of the invention, functions to precisely control the rate outwardly of fluid flow from reservoir  58  ( FIG. 31 ) and toward the patient. As before, the flow control means comprises a flow control member  126  that is telescopically receivable within casing  130  and a selector knob  134  that is interconnected with control member  126  in the manner shown in  FIGS. 15 and 16 . When the flow control member is properly positioned within outer casing  130 , the inner surface of the outer casing wall cooperates with channels  128  provided in the control member to form a plurality of generally spiral-shaped fluid flow passageways of different overall lengths and flow capacities. Selector knob  134 , which is rotatably mounted within housing portion  176 , functions to rotate the assembly made up of outer casing  130  and flow control member  126  ( FIG. 37 ). In this way, a selected outlet  132  in casing  130  can be selectively aligned with an outlet flow passageway  118  provided in forward housing portion  176  ( FIG. 30 ).  
         [0225]     Also forming a part of the fluid dispensing apparatus of this latest form of the invention is dispensing means for dispensing fluid to the patient. This dispensing means is also identical to that previously described and comprises an administration set  114  that is connected to the first portion  176  of housing  174  in the manner shown in  FIG. 27  of the drawings. The proximal end  116   a  of administration line  116  of the administration set is in communication with fluid passageway  118  in the manner best seen in  FIGS. 30 and 31 .  
         [0226]     Turning particularly to  FIGS. 30 and 37 , each of the shell vials  188  and  192  can be seen to be of the same construction as the shell vial illustrated in  FIG. 8A  and as earlier described herein. After removal of the vial cover  201 , which forms a part of the third portion of housing  174  ( FIGS. 30 and 37 ), vials  188  and  192  can be inserted into chambers  186  and  190  respectively. As the fill-vials are so introduced and the plungers  102  thereof are threadably interconnected with ends  194   a  of supports  194 , the sharp ends of the elongated needles  198  will pierce the central walls  102   a  of the elastomeric plungers. Continuous pushing movement of the vials into chambers  186  and  190  will cause the structural supports  194  to move the elastomeric plungers inwardly of the vial chambers. As the plungers move inwardly of the vial, the fluid contained within the vial chambers will be expelled therefrom into the hollow elongated needles  198 . As best seen in  FIG. 30 , the fluid will then flow past umbrella-type check valves  106  and into passageways  204  formed in third portion  180  of the apparatus housing. From passageway  204  the fluid will flow into passageway  182  and then into reservoir  58  of the bellows component  56  via inlet channel  60  ( FIGS. 30, 31 , and  37 ). It is to be understood that the vials  188  and  192  can contain the same or different medicinal fluids and can be introduced into their respective chambers either one at a time, or simultaneously.  
         [0227]     It is also to be understood that, if desired, the reservoir of the bellows component can be filled by alternate filling means of the character previously described, namely a filling means which comprises a syringe having a needle adapted to pierce the pierceable septum  84  which is mounted within third portion  180  of the apparatus housing. As the reservoir  58  fills with fluid either from the fill-vials or from the filling syringe, any gases trapped within the reservoir will be vented to atmosphere via vent means “V” mounted in portion  176  of the housing.  
         [0228]     Upon opening the fluid delivery path to the administration set in a conventional manner, the stored energy means, or member  67 , will tend to return to its starting configuration thereby controllably urging fluid flow outwardly of reservoir  58  via the flow control means of the invention which functions in the manner previously described. Indexing means of the character previously described functions to index the position of the selector knob. Similarly disabling means of the character previously described can be used to disable the apparatus of this latest form of the invention.  
         [0229]     Turning next to  FIGS. 38 through 48 , still another form of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral  212 . This alternate form of the apparatus of the invention is also similar in many respects to that shown in  FIGS. 1 through 26  and like numerals are used in  FIGS. 38 through 48  to identify like components. The primary difference between this latest form of the invention and that shown in  FIGS. 1 through 26  is that the vial-fill means for filling the device reservoir is of a different configuration from that used in both the first and second previously described embodiments of the invention. More particularly, as will presently be described in greater detail, this alternate form of vial-fill means comprises a vial cartridge having a hollow glass or plastic body portion that defines a fluid chamber that is closed by a pierceable, elastomeric septum.  
         [0230]     As best seen in  FIG. 38 , the apparatus here comprises an outer housing  214  having a first, second and third portions  216 ,  218  and  220  respectively. Disposed within outer housing  214  is an inner, expandable housing  56  which is identical in construction and operation to that described in connection with the embodiment of  FIGS. 1 through 26 .  
         [0231]     Disposed within second portion  218  of outer housing  214  is the novel stored energy means of the invention for acting upon inner expandable housing  56  in a manner to cause the fluid contained within fluid reservoir  58  thereof to controllably flow outwardly of the housing. In this latest form of the invention, this stored energy means is also identical in construction and operation to that previously described and comprises a constant force spring  67 .  
         [0232]     With regard to the fill means of this latest form of the invention, which is carried by the third portion  220  of the outer housing, as before, this important fill means functions to fill the reservoir  58  with the fluid to be dispensed. This fill means here comprises the previously described septum-fill means, which is identical to that previously described, and also includes the previously mentioned, cartridge-type fill-vial which is of the construction best seen in  FIG. 41A  of the drawings.  
         [0233]     As to the septum-fill means, as illustrated in  FIG. 41 , third portion  220  includes a fluid passageway  222  which is in communication with inlet  60  of fluid reservoir  58 . Proximate its lower end  222   a,  fluid passageway  222  communicates with a cavity formed within the third portion  220  of the housing. Disposed within cavity is a pierceable septum  84  that comprises a part of the septum-fill means of this latest form of the invention. As before, elastomeric septum  84  is held in position by a retainer  84   a  and is pierceable by the needle of the syringe which contains the medicinal fluid to be dispensed and which can be used in a conventional manner to fill or partially fill reservoir  58  via passageway  222 .  
         [0234]     Third portion  220  of the housing also includes a first chamber  226  for telescopically receiving the previously mentioned cartridge fill-vial, which is generally designated in the drawings by the numeral  227 . As shown in  FIG. 41 A , cartridge fill-vial  227  comprises a hollow glass or plastic body portion  228  that defines a fluid chamber  230 . Fill-vial  227  has an open first end  232  and a second end  234  that is closed by a pierceable, elastomeric septum  236 . An elastomeric plunger  237  is reciprocally movable within fluid chamber  230 . As shown in  FIG. 41 , a hollow needle to  240  is mounted within third portion  220  of the device housing and is located proximate the inboard end of chamber  226 . Hollow needle  240  is adapted to pierce septum  236  when the fill-vial is inserted into chamber  226  and pushed into the position shown in  FIG. 41 . More particularly, a pusher member  239  which is housed within a casing  239   a  ( FIG. 48 ) pushes the fill-vial inwardly of chamber  226 .  
         [0235]     Forming an important aspect of the apparatus of this latest form of the invention is a novel flow control means that is connected to first portion  216  of outer housing  214 . This flow control means, which is identical in construction and operation to that described in connection with the first embodiment of the invention, functions to precisely control the rate outwardly of fluid flow from reservoir  58  and toward the patient. As before, the flow control means comprises a flow control member  126  that is telescopically receivable within casing  130  and a selector knob  134  that is interconnected with control member  126  in the manner shown in  FIGS. 15 and 16 . When the flow control member is properly sealably positioned within outer casing  130 , the inner surface of the outer casing wall cooperates with channels  128  provided in the control member to form a plurality of generally spiral-shaped fluid flow passageways of different overall lengths, width, depths and flow capacities. Selector knob  134 , which is rotatably mounted within housing portion  216 , functions to rotate the assembly made up of outer casing  130  and flow control member  126 . In this way, a selected outlet  132  in casing  130  can be selectively aligned with an outlet flow passageway  118  provided in forward housing portion  216  ( FIG. 41 ).  
         [0236]     Also forming a part of the fluid dispensing apparatus of the latest form of the invention is dispensing means for dispensing fluid to the patient. This dispensing means is also identical to that previously described and comprises an administration set that is connected to the first portion  216  of housing  214  in the manner shown in  FIG. 38  of the drawings. The proximal end  116   a  of administration line  116  of the administration set is in communication with fluid passageway  118  in the manner best seen in  FIG. 41 .  
         [0237]     It is also to be understood that, if desired, the reservoir of the bellows component can also be filled by alternate filling means of the character previously described which comprises a syringe having a needle adapted to pierce the pierceable septum  84  which is mounted within third portion  220  of the apparatus housing. As the reservoir  58  fills with fluid from the fill-vials or from the filling syringe, any gases trapped within the reservoir will be vented to atmosphere via vent means “V” mounted in portion  216  of the housing.  
         [0238]     Upon opening the fluid delivery path to the administration set, the stored energy means, or member  67 , will tend to return to its starting configuration thereby controllably urging fluid flow outwardly of reservoir  58  via the flow control means of the invention which functions in the manner previously described. Indexing means of the character previously described functions to index the position of the selector knob. Similarly, as in the earlier described embodiments, disabling means of the character previously described can be used to disable the apparatus of this latest form of the invention.  
         [0239]     Turning next to  FIGS. 49 through 63 , still another form of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral  242 . This alternate form of the apparatus of the invention is also similar in many respects to that shown in  FIGS. 1 through 26  and like numerals are used in  FIGS. 49 through 63  to identify like components. The primary difference between this latest form of the invention and that shown in  FIGS. 1 through 26  is that the vial-fill means for filling the device reservoir is of a different configuration from that used in each of the previously described embodiments of the invention. More particularly, as will presently be described in greater detail, this alternate form of vial-fill means comprises a first vial cartridge that is of identical construction and operation to that described in connection with the embodiment of the invention shown in  FIGS. 38 through 48 . However, the vial-fill means also here includes a second vial cartridge that is of a uniquely different construction from the previously described medicament containing vials. More particularly, this second vial cartridge is specially designed to enable the intermixing of an internally contained lypholized drug with a suitable diluent or mixing agent prior to the delivery of the mixture of the fluid reservoir of the device.  
         [0240]     As best seen in  FIG. 49 , the apparatus here comprises an outer housing  242  having a first, second and third portions  244 ,  246  and  248  respectively. Disposed within outer housing  242  is an inner, expandable housing  56  which is identical in construction and operation to that described in connection with the embodiment of  FIGS. 1 through 26 .  
         [0241]     Disposed within second portion  246  of outer housing  242  is the novel stored energy means of the invention for acting upon inner expandable housing  56  in a manner to cause the fluid contained within fluid reservoir  58  thereof to controllably flow outwardly of the housing. In this latest form of the invention, this stored energy means is also identical in construction and operation to that previously described and comprises a constant force spring  67 .  
         [0242]     With regard to the fill means of this latest form of the invention, which is carried by the third portion  248  of the outer housing, as before, this important fill means functions to fill the reservoir  58  with the fluid to be dispensed. This fill means here comprises the previously described septum-fill means, which is identical to that previously described, and also includes the previously mentioned, first and second cartridge-type vial-fill-vials generally designated in  FIG. 52  by the numerals  252  and  272  respectively. As to the septum-fill means, as illustrated in  FIG. 52 , third portion  248  includes a fluid passageway  256  which is in communication with inlet  60  of fluid reservoir  58 . Proximate its lower end  256   a,  fluid passageway  256  communicates with a cavity  258  formed within the third portion  248  of the housing. Disposed within cavity  258  is an elastomeric pierceable septum  84  that comprises a part of the septum-fill means of this latest form of the invention. As before, septum  84  is held in position by a retainer  84   a  and is pierceable by the needle of the syringe which contains the medicinal fluid to be dispensed and which can be used in a conventional manner to fill or partially fill reservoir  58  via passageway  256 .  
         [0243]     Third portion  248  of the housing also includes a first chamber  260  for telescopically receiving the previously mentioned, first cartridge fill-vial  252 , which is identical in construction and operation to the previously described cartridge fill-vial  228 , the construction of which is shown in  FIG. 41A . As illustrated in  FIG. 52 , a hollow needle  240  is mounted within third portion  248  of the device housing and is located proximate the inboard end of chamber  260 . Hollow needle  240  is adapted to pierce septum  236  when the first cartridge fill-vial is inserted into chamber  260  and pushed forwardly into the position shown in  FIG. 52 .  
         [0244]     With respect to second reconstitution cartridge fill-vial  272 , this fill-vial, which is more clearly illustrated in  FIGS. 53 and 54  of the drawings, comprises a container of special design that uniquely contains a lyophilized drug  262  that is separated from a reconstituting fluid  264  by a barrier stopper  266  ( FIG. 53 ). Lyophilized drug  262  can, by way of example, comprise anti-infectives, cardiac drugs or various other types of beneficial agents.  
         [0245]     As illustrated in  FIG. 52 , portion  248  of the device housing includes a pair of spaced-apart pusher members  268  and  270  which engage plungers  237  and  271  respectively to push them forwardly of their respective container reservoirs.  
         [0246]     Considering in more detail the novel bypass cartridge assembly  272 , as best seen in  FIG. 53 , this cartridge assembly includes a vial  272  that is sealed at one end by elastomeric plunger  271  and at the other end by a pierceable septum  274  ( FIGS. 52 and 53 ). Formed intermediate the ends of vial  254  is a raised outer wall portion  272   a  which after installation of the cartridge permits fluid  264  to bypass a barrier stopper  266  as the barrier stopper is urged inwardly of the container by pressure exerted thereon by the fluid  264 , which is being pushed by plunger/stopper  271  resulting from force exerted on pusher element member  270 . Fluid  264  exerts pressure on barrier member  266  as a result of the inward movement of plunger  271  by the pusher member as the vial is fully mated with the apparatus housing.  
         [0247]     A continued inward pressure exerted on plunger  271  will cause fluid  264  to flow past barrier member  266  via the internal passageway defined wall portion  272   a  so as to reconstitute the lyophilized drug  262 . A continued pressure exerted on plunger  271  by the pusher member will cause the reconstituted drug formed by the fluid  264  which has been intermixed with drug  262  to flow through a hollow cannula  240  past check valve  106 , into a stub passageway  282  and then into a passageway  256  and finally into the device reservoir  58 .  
         [0248]     As previously mentioned, plunger  237 , which is disposed within vial  252 , is moved by a support  268  of a vial cover  280  ( FIG. 52 ) as the vial cover is mated with the apparatus housing and locked in position. As plunger  237  is moved inwardly of vial reservoir  252 , the fluid contained in the reservoir will be forced through the upper hollow needle  240 , passed the upper umbrella check valve  106  mounted within third housing portion  248 , into a stub passageway  282 , into a passageway  256  and finally into the device reservoir. As the fluid flows into the device reservoir, it will compress the stored energy means, or constant force spring  67  in the manner previously described.  
         [0249]     Turning to  FIGS. 55 and 56 , an alternate form of drug intermixing vial is there shown. This fill-cartridge is similar in some respects to fill-cartridge  254  and includes a vial  285  that is sealed at one end by a plunger  286  and at the other end by a pierceable septum  274 . Formed intermediate the ends of vial  285  is a plurality of internal fluid flow passageways  292  which permit fluid  264  to bypass member or elastomeric barrier stopper  290  as the barrier stopper is urged inwardly of the container by pressure exerted thereon by fluid  264 . Fluid  264  exerts pressure on barrier member  290  as a result of pusher member  270  of the housing exerting inward pressure on plunger  286 , which pressure is, in turn, caused by the inward movement of plunger  286  as vial housing  285  is mated with the device housing portion  248 .  
         [0250]     A continued inward pressure exerted on plunger  286  will cause fluid  264  to flow past barrier member  290  via flow passageways  292  so as to reconstitute lyophilized drug  262  ( FIG. 55 ). Further pressure exerted on plunger  286  will cause the reconstituted drug formed by the fluid  264  which has been intermixed with drug  262  to flow through hollow cannula  240 , past lower check valve  106 , into a stub passageway  277 , into a passageway  256  and finally into the device reservoir  58  ( FIG. 52 ).  
         [0251]     Forming an important aspect of the apparatus of this latest form of the invention is a novel flow control means that is connected to first portion  244  of the outer housing. This flow control means, which is identical in construction and operation to that described in connection with the first embodiment of the invention, once again functions to precisely control the rate outwardly of fluid flow from reservoir  58  and toward the patient. As before, the flow control means comprises a flow control member  126  that is telescopically receivable within casing  130  and a selector knob  134  that is interconnected with control member  126  in the manner shown in  FIGS. 15 and 16 . When the flow control member is properly positioned within outer casing  130 , the inner surface of the outer casing wall cooperates with channels  128  provided in the control member to form a plurality of generally spiral-shaped fluid flow passageways of different overall lengths and flow capacities. Selector knob  134 , which is rotatably mounted within housing portion  244 , functions to rotate the assembly made up of outer casing  130  and flow control member  126 . In this way, a selected outlet  132  in casing  130  can be selectively aligned with an outlet flow passageway  118  provided in forward housing portion  244  ( FIG. 52 ).  
         [0252]     Also forming a part of the fluid dispensing apparatus of this latest form of the invention is dispensing means for dispensing fluid to the patient. This dispensing means is also identical to that previously described and comprises an administration set  114  that is connected to the first portion  244  of housing  242  in the manner shown in  FIG. 49  of the drawings. The proximal end  116   a  of administration line  116  of the administration set is in communication with fluid passageway  118  in the manner best seen in  FIG. 52 .  
         [0253]     It is also to be understood that, if desired, the reservoir of the bellows component can also be filled by alternate filling means of the character previously described which comprises a syringe having a needle adapted to pierce the pierceable septum  84  which is mounted within third portion  248  of the apparatus housing. As the reservoir  58  fills with fluid either from the fill-vials or from the filling syringe, any gases trapped within the reservoir will be vented to atmosphere via vent means “V” mounted in portion  244  of the housing.  
         [0254]     Referring now to  FIGS. 64 through 95 , yet another embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral  302 . This alternate form of the apparatus of the invention is similar in some respects to that shown in  FIGS. 1 through 26  and like numerals are used in  FIGS. 64 through 84  to identify like components. The primary difference between this latest form of the invention and those previously discussed concerns the provision of a differently configured device housing and a differently configured flow rate control means.  
         [0255]     As best seen in  FIG. 64 , the apparatus here comprises an outer housing  304  having first and second portions  306  and  308  respectively. Disposed within outer housing  304  is an inner, expandable housing  310 , which is generally similar in construction and operation to expandable housing  56 , which housing was described in connection with the embodiment of  FIGS. 1 through 26 .  
         [0256]     Also disposed within second portion  308  of outer housing  304  is the novel stored energy means of the invention for acting upon inner expandable housing  310  in a manner to cause the fluid contained within fluid reservoir  312  thereof to controllably flow outwardly of the housing. In this latest form of the invention, this stored energy means is identical in construction and operation to that previously described and here comprises a constant force spring  67  of the character previously described herein.  
         [0257]     As in the earlier described embodiments of the invention, the present invention includes fill means, which are here carried by the first portion  306  of the outer housing. As before, the fill means functions to fill the reservoir  312  with the fluid to be dispensed. As best seen in  FIG. 67 , first housing portion  306  includes a fluid passageway  313  that is in communication with the inlet  312   a  of fluid reservoir  312 . Proximate its lower end  313   a,  fluid passageway  313  communicates with a cavity  315  formed within the first portion of the housing. Disposed within cavity  315  is a pierceable elastomeric septum  317  that comprises a part of the fill means of this latest form of the invention. Septum  317  is held in position by a retainer  317   a  and is pierceable by the needle of the syringe which contains the medicinal fluid to be dispensed and which can be used in a conventional manner to fill or partially fill reservoir  312  via passageway  313 . As the reservoir fills, and gases trapped within the reservoir will be vented via vents “V”.  
         [0258]     Turning particularly to  FIGS. 76 through 83 , the novel flow control means of the apparatus of this latest form of the invention is there shown. This important flow control means functions to precisely control the rate outwardly of fluid flow from reservoir  312  and toward the patient. In this latest form of the invention, the flow control means comprises a flow rate control assembly generally designated in the drawings by the numeral  314 . This flow rate control assembly is non-rotatably mounted within housing portion  306  and includes an elongated spline  315  that functions to align the assembly within the outer housing. As best seen in  FIGS. 76 and 77 , this novel flow rate control assembly here comprises an inlet manifold  316  having an inlet port  318  ( FIG. 76 ) that is in communication with the outlet  312   a  of the fluid reservoir  312  ( FIG. 69 ) and an outlet manifold  320  that is interconnected with inlet manifold  316  by means of a plurality of interconnected flow rate control plates  322 ,  324 ,  326 ,  328 ,  330 ,  332 ,  334 ,  336 ,  338  and  340  (see also  FIG. 80 ). The rate control plates can be interconnected by various well-known techniques including adhesive, sonic, thermal, laser and chemical bonding without disturbing the integrity of the flow channels. As indicated in  FIGS. 83 and 84 , outlet manifold  320  has a plurality of circumferentially spaced outlet ports, each of which is in communication with an outlet port of a selected one of the rate control plates. In a manner presently to be described, by using the selector means of the apparatus these circumferentially spaced outlet ports can be selectively brought into communication with outlet passageway  380  of the apparatus and with the administration line  341  of the administration set  343 .  
         [0259]     As best seen by referring to  FIG. 80 , each of the flow rate control plates is provided with an elongated micro-channel of a particular configuration. These micro-flow channels can be formed in various ways known to those skilled in the art. For example, U.S. Pat. No. 6,176,962 issued to Soane, et al., describes methods for constructing micro-channel structures for use in micro-fluidic manipulations. Similarly, International Publication WO 99/5694A1 describes such methods. When the rate control plates are assembled in the manner shown in  FIGS. 80 and 83 A, it is apparent that the micro-channel formed in each of the rate control plates will cooperate with the adjacent planar surface of the next adjacent rate control plate to form a fluid flow control channel through which the fluid flowing into inlet  318  can controllably flow. As indicated in the drawings, one end of each of the micro-channels is in communication with the inlet port  318  of the inlet manifold  316  via a center port  319  and the other end of each of the micro-channel is in communication with a selected one of the circumferentially spaced outlet ports provided in the outlet manifold  320 . More particularly, as can be seen by referring to  FIGS. 80, 81  and  84  of the drawings, outlet  322   a  of rate control plate  322  is in communication with outlet  341  of outlet manifold  320 ; outlet  324   a  of rate control plate  324  is in communication with outlet  342  of outlet manifold  320 ; outlet  326   a  of control plate  326  is in communication with outlet  343  of manifold  320 ; outlet  328   a  of control plate  328  is in communication with outlet  344  of outlet manifold  320  and outlet  330   a  of rate control  330  is in communication with outlet  345  of outlet manifold  320 , and outlet  332   a  of rate control plate  332  is in communication with outlet  346  of outlet manifold  320 . In similar fashion, outlet  334   a  of rate control plate  334  is in communication with outlet  347  of outlet manifold  320 ; outlet  336   a  of rate control plate  336  is in communication with outlet  348  of manifold  320  and outlet  338   a  of control plate  338  is in communication with outlet  349  of outlet manifold  320  and outlet  340   a  of rate control plate  340  is in communication with outlet  350  of outlet manifold  320 .  
         [0260]     With the construction of the flow control means shown in the drawings, fluid will flow from reservoir  312  into inlet port  318  of inlet manifold  316 , through a filter member  353  ( FIGS. 82A and 83 ) and thence into micro-channel  354  formed in plate  322 . By controlling the length, width and depth of the micro-channel  354 , the rate of fluid flow flowing outwardly of outlet  322   a  can be precisely controlled. In a manner presently to be described, the fluid will then flow onwardly toward the administration set via the flow regulation means of the invention. It is to be understood that micro-channel  354  can take various forms and can be of varying length, width and depth to precisely control the rate of fluid flow their through.  
         [0261]     Fluid flowing through inlet port  318  will also flow into micro-channel  356  formed in rate control plate  324 . Once again, depending upon the length, width and depth of micro-channel  356 , the rate of fluid flowing outwardly of outlet  324 a can be precisely controlled. In similar manner, fluid flowing through inlet port  318  will fill micro-channel  358  formed in rate control plate  326 , will fill micro-channel  360  formed in plate  328 , will fill micro-channel  362  formed in rate control plate  330 , will fill rate control micro-channel  364  formed in rate control plate  332 , will fill rate control micro-channel  366  formed in rate control plate  334 , will fill rate control micro-channel  368  formed in rate control plate  336 , will fill flow control micro-channel  370  formed in rate control plate  338  and will fill rate control micro-channel  372  formed in rate control plate  340 . After flowing through the rate control micro-channels formed in the various indexedly aligned rate control plates, the fluid will flow onwardly toward outlet manifold  320  and will fill each of the stub passageways  375  formed therein ( FIG. 84  and  85 ). The rate of flow of fluid flowing outwardly of each of the outlet ports of the various rate control plates will, of course depend upon the configuration of the individual rate control micro-channels formed in the rate control plates.  
         [0262]     As shown in  FIG. 74 , selector knob  378  is provided with a plurality of circumferentially spaced-apart indexing cavities  379  that closely receive an indexing finger  389 , which forms a part of the indexing means of the invention, which means comprises a front bezel  384  that is connected to the apparatus housing (see  FIGS. 64 and 75 ). Indexing finger  389  is continuously urged into engagement with a selected one of the indexing cavities  379  by a coil spring  391  that also forms a part of the indexing means of the invention. Coil spring  391  can be compressed by an inward force exerted on an indexing shaft  393  that is movable from an extended position to an inward, finger release position wherein spring  391  is compressed and finger  389  is retracted from a selected indexing cavity  379 . With finger  389  in its retracted position, it is apparent that control knob  378  can be freely rotated to a position wherein a gripping member  394  can be aligned with selected flow rate indicia  395  formed on the front bezel  384  of the apparatus housing.  
         [0263]     When the selector knob is in the desired position and pressure is released on indexing shaft  393 , spring  391  ( FIG. 67 ) will urge finger  389  of the indexing means of the invention into locking engagement with one of the indexing cavities  379  ( FIG. 74 ) thereby placing a selected one of flow control channels of a flow rate control plate in communication with flow passageway  378   a  ( FIGS. 67A and 76 ) of the flow control knob. As the fluid flows outwardly of the apparatus due to the urging of the stored energy means or spring member  67 , the bellows structure  310  will be collapsed and at the same time member  69  will travel inwardly of the housing. Member  69 , which forms a part of the volume indicator means of the invention, includes a radially outwardly extending indicating finger  110  that is visible through a volume indicator window  160  that is provided in a second portion  308  of the apparatus housing and also comprises a part of the volume indicator means of the invention. Indicia  161 , which are provided on indicator window  160  ( FIG. 64 ), function to readily indicate to the caregiver the amount of fluid remaining within fluid reservoir  312  at any point in time.  
         [0264]     Referring to  FIGS. 64 and 73 , disabling means, shown here as a disabling shaft  164  that is telescopically movable within a passageway formed within housing portion, functions in the manner previously described to disable the device.  
         [0265]     Referring particularly to  FIGS. 67, 76  and  77 , a selector knob  378 , which comprises a part of the selector means of the invention, is sealably connected to outlet manifold  320  by means of O-Rings “O” and is rotatable with respect thereto. As previously mentioned, this novel selector means of the invention functions to control the flow of fluid from outlet manifold  320  toward the administration set  343 . More particularly, as illustrated in  FIGS. 93, 93A  and  93 B, selector knob  378  is provided with a circumferentially extending flow channel  378   a  which is selectively in communication with stub passageways  375  of outlet manifold  320  depending upon the position of the selector knob. As illustrated in  FIGS. 93A and 93B , the rearwardly extending generally cylindrical, reduced-diameter portion  378 c of the control knob, which circumscribes the outlet manifold  320 , is provided with a circumferentially extending, elastomeric band  382  which prevents fluid leakage between then the outlet manifold and the flange  378   c.  Outlet manifold  320  is also provided with a similarly configured, circumferentially extending, elastomeric band  384 . As indicated in  FIG. 93A , elastomeric band  384  has an opening  384   a  that is in alignment with fluid outlet passageway  380  formed in the first portion  306  of the outer housing (see also  FIG. 67 ). Elastomeric band  382  also has an opening  382   a  which is aligned with a radially extending flow passageway  378   b  formed on portion  378   c  of the control knob, which, in turn, is in communication with circumferentially extending flow channel  378   a  ( FIG. 93A ). With this construction, when the control knob  378  is rotated to a position such as that illustrated in  FIG. 93A , wherein one of the outlets of the outlet manifold  320  is in alignment with the opening  382   a  formed in the elastomeric band  382 , fluid can flow from that outlet and into circumferentially extending flow channel  378   a.  From flow channel  378   a,  the fluid can flow into radially extending passageway  378   b,  through opening  384   a  and into passageway  380 . From passageway  380 , the fluid can flow onwardly into the dispensing means or administration set  343 . The rate at which the fluid flows toward the administration set depends, of course, upon which rate control plate outlet is in communication with radial passageway  378   b  formed in the control knob. By way of example, with the control knob  378  in the position shown in  FIG. 93A , it is to be observed that the fluid flowing toward the administration set is flowing from outlet  322   a  of rate control plate  322  and will flow at a rate determined by the configuration of rate control micro-channel  354  (see  FIGS. 80 and 80 A).  
         [0266]     Referring now to  FIGS. 96 through 106 , still another embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral  392 . This alternate form of the apparatus of the invention is similar in some respects to that shown in  FIGS. 64 through 95  and like numerals are used in  FIGS. 96 through 106  to identify like components. The primary difference between this latest form of the invention and that discussed in the embodiment of  FIGS. 64 through 95  concerns the provisions of a differently configured flow rate control means. More particularly, the flow rate control means of this latest form of the invention comprises a single fixed, non-variable flow rate control rather than a variable flow rate control as described in the immediately preceding paragraphs.  
         [0267]     As best seen in  FIG. 96 , this latest form of the apparatus of the invention comprises an outer housing  394  having first and second portion  396  and  398  respectively. Disposed within outer housing  394  is an inner, expandable housing  310 , which is identical in construction and operation to the expandable housing, which was described in connection with the embodiment of  FIGS. 64 through 95 .  
         [0268]     Disposed within second portion  398  of outer housing  394  is the novel stored energy means of the invention for acting upon inner expandable housing  310  in a manner to cause the fluid contained within fluid reservoir  312  thereof to controllably flow outwardly of the housing ( FIG. 101 ). In this latest form of the invention, this stored energy means is identical in construction and operation to that previously described and here comprises a constant force spring  67 .  
         [0269]     As in the earlier described embodiment of the invention, the present invention includes fill means which are carried by the first portion  396  of the outer housing. As before, the fill means functions to fill the reservoir  312  with the fluid to be dispensed. As best seen in  FIG. 99 , first portion  396  includes a fluid passageway  400  in communication with the inlet  312   a  of fluid reservoir  312 . Proximate its lower end  400   a,  fluid passageway  400  communicates with a cavity  402  formed within the first portion of the housing. Disposed within cavity  402  is a pierceable septum  317  that comprises a part of the fill means of this latest form of the invention. Septum  317  is held in position by a retainer  317   a  and is pierceable by the needle of the syringe which contains the medicinal fluid to be dispensed and which can be used in a conventional manner to fill or partially fill reservoir  312  via passageway  400 . As the fluid to be dispensed flows toward the fluid reservoir, any gases trapped within the reservoir will be vented to atmosphere through the vents “V”.  
         [0270]     Turning particularly to  FIGS. 99 through 101 , the alternate form of the flow control means of the apparatus of this latest form of the invention is there shown. As before, this alternate flow control means functions to precisely control the rate outwardly to fluid flow from reservoir  312  and toward the patient. In this latest form of the invention, the flow control means comprises a flow rate control assembly generally designated in the drawings by the numeral  404 . This novel flow rate control assembly here comprises an inlet manifold  406  having an inlet port  408  that is in communication with the outlet  312   a  of the fluid reservoir  312  and a fixedly mounted, outlet manifold  410  that is interconnected with inlet manifold  406  by means of a pair of interconnected plates  412  and  414 . Plate  412  is identical in construction and operation to the previously describe flow rate control plate  322  and is provided with a micro-channel  354  (see also  FIGS. 80 and 80 A). Plate  414 , on the other hand, is a generally cylindrically shaped plate having planar front and rear surfaces. With this construction, the rear surface of plate  414  cooperates with the micro-channel  354  of plate  412  to provide a closed flow control channel which controls the rate of fluid flow from the reservoir toward the administration set of the apparatus of the invention. As indicated in the drawings, outlet manifold  410  has an outlet passageway  416  that is in communication with the outlet port of rate control plate  412 .  
         [0271]     With the construction of the flow control means shown in the drawings, fluid will flow from reservoir  312  into inlet port  408  of the inlet manifold and then into micro-channel  354  formed in plate  412 . By controlling the length, width and depth of the micro-channel  354 , the rate of fluid flow flowing into outlet passageway  416  can be precisely controlled. As previously mentioned, the fluid will flow from passageway  416  onwardly toward the administration set via the device outlet passageway  418  ( FIG. 99 ).  
         [0272]     As in the earlier described embodiments, that apparatus includes volume indicator means and disabling means of the character previously described which can be used to determine the volume of fluid remaining in the device reservoir and, when desired to disable the apparatus.  
         [0273]     Referring now to  FIGS. 107 through 118 , yet another embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral  422 . This alternate form of the apparatus of the invention is similar in some respects to that shown in  FIGS. 49 through 63  and like numerals are used in  FIGS. 107 through 118  to identify like components. The primary difference between this latest form of the invention and those previously discussed herein concerns the provision of a fill means, such as that shown in the embodiment of the invention illustrated in  FIGS. 49 through 63 , and the provision of a flow rate control means such as that shown in the embodiment of the invention illustrated in  FIGS. 64 through 95 .  
         [0274]     As best seen in  FIG. 107 , the apparatus here comprises an outer housing  424  having first, second and third portions  426 ,  428  and  429  respectively. Disposed within outer housing  424  is an inner, expandable housing  430 , which is generally similar in construction and operation to expandable housing  310 , which housing was described in connection with the embodiment of  FIGS. 64 through 95 .  
         [0275]     Also disposed within outer housing  424  is the novel stored energy means of the invention for acting upon inner expandable housing  430  in a manner to cause the fluid contained within the fluid reservoir thereof to controllably flow outwardly of the housing. In this latest form of the invention, this stored energy means is identical in construction and operation to that previously described and here comprises a constant force spring  67  of the character previously described.  
         [0276]     As in the earlier described embodiments of the invention, the present invention includes fill means, which are here carried by the third portion  426  of the outer housing. As before, the fill means functions to fill the reservoir defined by bellows member  430  with the fluid to be dispensed. As best seen in  FIG. 108 , third housing portion  429  includes a fluid passageway  433  that is in communication with the inlet or passageway  435  of the fluid reservoir. Proximate its lower end  433   a,  fluid passageway  433  communicates with a cavity  436  formed within the third portion of the housing. Disposed within cavity  436  is a pierceable septum  317  that comprises a part of the fill means of this latest form of the invention. Septum  317 , which is identical in construction and operation to that previously described, is held in position by a retainer  317   a  and is pierceable by the needle of the syringe which contains the medicinal fluid to be dispensed and which can be used in a conventional manner to fill or partially fill the device reservoir via passageway  433 . As the reservoir fills, any gases trapped within the reservoir will be vented via vent “V”.  
         [0277]     Turning particularly to  FIG. 108 , the novel flow control means of the apparatus of this latest form of the invention is there shown and includes a flow rate control assembly generally designated by the numeral  314 . This important flow control means, which is identical in construction and operation to that discussed in connection with the embodiment of the invention shown in  FIGS. 64 through 95 , functions to precisely control the rate outwardly of fluid flow from the device reservoir and toward the patient. As before, flow rate control assembly  314  is non-rotatably mounted within the outer housing and is of a construction illustrated in  FIGS. 76 through 95 . Reference should be made to these Figure drawings and to the earlier discussion thereof to more completely understand the construction and operation of this unique flow rate control assembly of this latest form of the invention.  
         [0278]     As shown in  FIG. 108 , a selector knob  378 , which is of an identical construction to that previously described, is used to controllably rotate the flow rate control assembly. Selector knob  378  as operably associated with the indexing means of the invention, which means is also identical in construction and operation to that previously described.  
         [0279]     As the fluid flows outwardly of the apparatus due to the urging of the stored energy means or spring member  67 , the bellows structure  430  will be collapsed and at the same time member  69  will travel inwardly of the housing. Member  69 , which forms a part of the volume indicator means of the invention, includes a radially outwardly extending indicating finger  110  that is visible through a volume indicator window  160  that is provided in a second portion  428  of the apparatus housing and also comprises a part of the volume indicator means of the invention. Indicia  161 , which are provided on indicator window  160  ( FIG. 107 ), function to readily indicate to the caregiver the amount of fluid remaining within fluid reservoir of the device at any point in time.  
         [0280]     Referring to  FIG. 107 , disabling means, shown here as a disabling shaft  164  that is telescopically movable within a passageway formed within the housing portion, functions in the manner previously described to disable the device.  
         [0281]     With regard to the fill means of this latest form of the invention, which is carried by the third portion  429  of the outer housing, as before, this important fill means functions to fill the device reservoir with the fluid to be dispensed. This fill means here comprises the previously described septum-fill means and also includes the previously mentioned fill-vials generally designated in  FIG. 108  by the numerals  252  and  254  respectively.  
         [0282]     Turning to  FIGS. 108 and 113  through  118 , the fill-vials of the fill means of the dispensing apparatus of this latest form of the invention are there illustrated. These fill-vials, which are of identical construction and operation to those shown in  FIG. 52  and earlier described herein, comprise cartridge fill-vial  252  and a lyophilized drug fill-vial  254 . As shown in  FIG. 108 , the third portion  429  of the housing also includes a first chamber  440  for telescopically receiving cartridge fill-vial  252 . As illustrated in  FIG. 108 , a hollow needle  442  is mounted within third portion  429  of the device housing and is located proximate the inboard end of chamber  440 . Hollow needle  442  is adapted to pierce septum  236  when the cartridge fill-vial  252  is inserted into chamber  440  and pushed forwardly into the position shown in  FIG. 108 .  
         [0283]     With respect to second cartridge fill-vial  254 , this fill-vial, which is more clearly illustrated in  FIGS. 115 and 116  of the drawings comprises a container of special design that uniquely contains a lyophilized drug  262  that is separated from a reconstituting fluid  264  by a barrier stopper  266  ( FIG. 115 ). Lyophilized drug  262  can, by way of example, comprise anti-infectives or various other types of beneficial agents. Cartridge fill-vial  254  is identical in construction and operation to that shown in  FIGS. 53 and 54  and previously described herein. As shown in  FIG. 108 , the third portion  429  of the housing also includes a second chamber  448  for telescopically receiving cartridge fill-vial  254 . As illustrated in  FIG. 108 , a hollow needle  450  is mounted within third portion  429  of the device housing and is located proximate the inboard end of chamber  448 . Hollow needle  450  is adapted to pierce septum  274  when the cartridge fill-vial  254  is inserted into chamber  448  and pushed forwardly into the position shown in  FIG. 108 .  
         [0284]     As illustrated in  FIG. 108 , the vial cover  443  of portion  429  of the device housing includes a pair of spaced-apart pusher members  445  and  447  which engage plungers  237  and  270  respectively to push them forwardly of their respective container reservoirs (see also  FIGS. 111 and 112 ).  
         [0285]     As the vial cover  443  is mated with the apparatus housing, the fluid contained in the vial reservoirs will be forced through the upper and lower hollow needles  442  and  450 , passed the upper umbrella check valves  453  mounted within third housing portion  429 , into a stub passageways  455 , into passageways  433  and  435  and finally into the device reservoir. As the fluid flows into the device reservoir, it will compress the stored energy means, or constant force spring  67 , in the manner previously described.  
         [0286]     Turning to  FIGS. 117 and 118 , an alternate form of drug intermixing vial is there shown. This fill-cartridge is identical in construction and operation to that previously described herein and illustrated in  FIGS. 55 and 56 . This alternate form of drug intermixing vial can be used in place of vial  254  during the reservoir filling step.  
         [0287]     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.