Abstract:
A compact fluid dispenser for use in controllably dispensing fluid medicaments, such as, antibiotics, oncolytics, hormones, steroids, blood clotting agents, analgesics, and like medicinal agents from prefilled containers at a uniform rate. The dispenser uniquely includes a stored energy source that is provided in the form of a substantially constant-force, compressible-expandable wave spring that provides the force necessary to continuously and uniformly expel fluid from the device reservoir. The device further includes a fluid flow control assembly that precisely controls the flow of medicament solution to the patient.

Description:
[0001]     This is a Continuation Application of co-pending U.S. Ser. No. 10/855,425 filed May 26, 2004. 
     
    
     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 compressible 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, continuous fluid delivery management at a low cost in those cases where a variety of precise dosage schemes 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 a 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 microcapillary multichannel 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.  
         [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 I-V chemotherapy and can accurately deliver fluids to the patient in precisely the correct quantities and at extended microfusion 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 compressible-expandable spring member that provides the force necessary to substantially, uniformly dispense various solutions from standard prefilled 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 biopharmaceuticals, and the like from a prefilled 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, and like medicinal agents from prefilled containers at a uniform rate.  
         [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 of in which a stored energy source is provided in the form of a compressible-expandable spring member that provides the force necessary to continuously and substantially 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 fluid dispenser which is adapted to be used with conventional prefilled drug containers to deliver beneficial agents therefrom in a precise and sterile manner.  
         [0022]     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.  
         [0023]     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  
         [0024]     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.  
         [0025]     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  
       [0026]      FIG. 1  is a generally perspective left front view of one embodiment of the medicament infusion apparatus of the present invention for dispensing fluids at a uniform rate.  
         [0027]      FIG. 2  is a generally perspective right front view of the embodiment of the medicament infusion apparatus shown in  FIG. 1 .  
         [0028]      FIG. 3  is an enlarged, longitudinal cross-sectional view of the apparatus shown in  FIG. 1 .  
         [0029]      FIG. 4  is an enlarged, cross-sectional view of the area designated as “ 4 ” in  FIG. 3 .  
         [0030]      FIG. 5  is a right end view of the apparatus shown in  FIG. 3 .  
         [0031]      FIG. 6  is an exploded view of the forward portion of the apparatus shown in  FIG. 3 .  
         [0032]      FIG. 7  is a cross-sectional view taken along lines  7 - 7  of  FIG. 6 .  
         [0033]      FIG. 8  is a view taken along lines  8 - 8  of  FIG. 6 .  
         [0034]      FIG. 9  is a cross-sectional view taken along lines  9 - 9  of  FIG. 8 .  
         [0035]      FIG. 10  is a view taken along lines  10 - 10  of  FIG. 6 .  
         [0036]      FIG. 11  is a greatly enlarged cross-sectional view of one form of the rate control assembly of the invention.  
         [0037]      FIG. 12  is an exploded, cross-sectional view of the rate control assembly shown in  FIG. 11 .  
         [0038]      FIG. 13  is a generally perspective, exploded front view of the rate control assembly shown in  FIG. 11 .  
         [0039]      FIG. 14  is a generally perspective, exploded rear view of the rate control assembly shown in  FIG. 11 .  
         [0040]      FIG. 15  is a cross-sectional view taken along lines  15 - 15  of  FIG. 11 .  
         [0041]      FIG. 16  is a view similar to  FIG. 15 , but showing an alternate form of flow rate control component.  
         [0042]      FIG. 17  is a generally perspective, exploded view of an alternate form of flow rate control assembly.  
         [0043]      FIG. 18  is a generally perspective, exploded view of yet another alternate form of the fluid flow rate assembly of the invention.  
         [0044]      FIG. 19  is a cross sectional view of still another form of the fluid rate control assembly of the invention.  
         [0045]      FIG. 19A  is an exploded perspective view of the rate control assembly shown in  FIG. 19 .  
         [0046]      FIG. 19B  is a generally diagrammatic, tabular view illustrating various types of springs that can be used as the stored energy source of the invention.  
         [0047]      FIG. 19C  is a generally diagrammatic, tabular view further illustrating various types of springs that can be used as the stored energy source of the invention.  
         [0048]      FIG. 19D  is a generally diagrammatic, tabular view further illustrating various types of springs that can be used as the stored energy source of the invention.  
         [0049]      FIG. 19E  is a generally diagrammatic, tabular view further illustrating various types of springs that can be used as the stored energy source of the invention.  
         [0050]      FIG. 19F  is a generally diagrammatic, tabular view further illustrating various types of springs that can be used as the stored energy source of the invention.  
         [0051]      FIG. 20  is a generally perspective view of an alternate embodiment of the infusion apparatus of the present invention for dispensing fluids at a uniform rate.  
         [0052]      FIG. 21A  is an enlarged, longitudinal cross-sectional view of the forward portion of the apparatus shown in  FIG. 20 .  
         [0053]      FIG. 21B  is an enlarged, cross-sectional view of the rear portion of the apparatus.  
         [0054]      FIG. 21C  is an enlarged, cross-sectional view of the area designated as  21 C in  FIG. 21A .  
         [0055]      FIG. 21D  is an enlarged, cross-sectional view of the area designated as  21 D in  FIG. 21A .  
         [0056]      FIG. 21E  is an enlarged, cross-sectional view of the elastomeric sealing band shown in  21 E in  FIG. 21D .  
         [0057]      FIG. 21F  is an enlarged, cross-sectional view of the elastomeric sealing band shown in  FIG. 21C .  
         [0058]      FIG. 22  is a cross-sectional view similar to  FIG. 21 , but showing the apparatus in a fluid fill mode.  
         [0059]      FIG. 22A  is a cross-sectional view taken along lines  22 A- 22 A of  FIG. 22 .  
         [0060]      FIG. 23  is a cross-sectional view of one of the prefilled medicament shell vials that can be used to fill the fluid reservoir of the apparatus shown in  FIG. 21 .  
         [0061]      FIG. 24  is a view taken along lines  24 - 24  of  FIG. 23 .  
         [0062]      FIG. 25  is an end view of the apparatus shown in  FIG. 21 .  
         [0063]      FIG. 26  is a view taken along lines  26 - 26  of  FIG. 25 .  
         [0064]      FIG. 27  is a cross-sectional view taken along lines  27 - 27  of  FIG. 21B .  
         [0065]      FIGS. 28 and 28 A, when considered together comprise a generally perspective, exploded view of the various internal operating components of this latest form of the apparatus of the invention.  
         [0066]      FIG. 29  is a generally perspective, exploded view of one form of the indexing means of the invention shown in  FIG. 21A .  
         [0067]      FIG. 30  is a fragmentary, front view similar to the front view shown in  FIG. 25 , but better showing the configuration of the indexing means of the invention.  
         [0068]      FIG. 31  is a cross-sectional view taken along lines  31 - 31  of  FIG. 30 .  
         [0069]      FIG. 32  is an enlarged, fragmentary, bottom view of the forward portion of the apparatus shown in  FIG. 22 .  
         [0070]      FIG. 33  is a cross-sectional view taken along lines  33 - 33  of  FIG. 32  but rotated 90° counterclockwise.  
         [0071]      FIG. 34  is a fragmentary, cross-sectional view similar to  FIG. 33  but showing the indexing means in a locked position.  
         [0072]      FIG. 35  is a generally perspective, front view of one form of the fluid flow control assembly of the apparatus of the invention.  
         [0073]      FIG. 36  is a generally perspective, exploded front view of the fluid flow control assembly shown in  FIG. 35 .  
         [0074]      FIG. 37  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. 36 .  
         [0075]      FIG. 38  is a generally perspective, rear view of the fluid flow control assembly of the apparatus of the invention.  
         [0076]      FIG. 39  is a generally perspective, exploded rear view of the fluid flow control assembly shown in  FIG. 38 .  
         [0077]      FIG. 40  is a generally perspective view of an alternate form of the flow control member of the invention.  
         [0078]      FIG. 40A  is a generally perspective view of yet another form of the flow control member of the invention.  
         [0079]      FIG. 41  is a front view of the assembly shown in  FIG. 35 .  
         [0080]      FIG. 42  is a cross-sectional view taken along lines  42 - 42  of  FIG. 41 .  
         [0081]      FIG. 43  is a view taken along lines  43 - 43  of  FIG. 42 .  
         [0082]      FIG. 44  is a cross-sectional view taken along lines  44 - 44  of  FIG. 42 .  
         [0083]      FIG. 45  is a cross-sectional view taken along lines  45 - 45  of  FIG. 42 .  
         [0084]      FIG. 46  is a generally perspective view of an alternate embodiment of the fluid delivery apparatus of the present invention for dispensing fluids at a uniform rate.  
         [0085]      FIG. 47  is an enlarged, longitudinal cross-sectional view of the embodiment of the invention shown in  FIG. 46 .  
         [0086]      FIG. 47A  is an enlarged, cross-sectional view of the area designated as  47 A in  FIG. 47 .  
         [0087]      FIG. 47B  is an enlarged, cross-sectional view of the elastomeric sealing band shown in  FIG. 47A .  
         [0088]      FIG. 48  is view taken along lines  48 - 48  of  FIG. 47 .  
         [0089]      FIG. 49  is a bottom view of the apparatus shown in  FIG. 47 .  
         [0090]      FIG. 50  is an enlarged view of one of the fill vial assemblies shown in  FIG. 47 .  
         [0091]      FIG. 50A  is a view taken along lines  50 A- 50 A of  FIG. 50 .  
         [0092]      FIG. 51  is a generally perspective, exploded view of fluid delivery apparatus shown in  FIG. 47   
         [0093]      FIG. 52  is cross-sectional view taken along lines  52 - 52  of  FIG. 47 .  
         [0094]      FIG. 53  is a generally perspective view of yet another embodiment of the present invention for dispensing fluids at a uniform rate.  
         [0095]      FIG. 54  is an enlarged, longitudinal cross-sectional view of the embodiment of the invention shown in  FIG. 53 .  
         [0096]      FIG. 54A  is an enlarged, cross-sectional view of the area designated as  54 A in  FIG. 54 .  
         [0097]      FIG. 54B  is an enlarged, cross-sectional view of the elastomeric sealing band shown in  FIG. 54A .  
         [0098]      FIG. 55  is a top view of the apparatus shown in  FIG. 54 .  
         [0099]      FIG. 56  is cross-sectional view taken along lines  56 - 56  of  FIG. 54 .  
         [0100]      FIG. 57  is a left end view of the apparatus shown in  FIG. 54 .  
         [0101]      FIG. 58  is a side view of the vial cover component of the apparatus.  
         [0102]      FIG. 59  is a view taken along lines  59 - 59  of  FIG. 58 .  
         [0103]      FIG. 60  is a generally perspective exploded view of this latest embodiment of the invention.  
         [0104]      FIG. 61  is an enlarged, longitudinal, cross-sectional view of one of the fill vial-assemblies shown in  FIG. 54 .  
         [0105]      FIG. 62  is a cross-sectional view taken along lines  62 - 62  of  FIG. 61 .  
         [0106]      FIG. 63  is an enlarged, longitudinal, cross-sectional view of the other fill vial assembly of the apparatus of the invention.  
         [0107]      FIG. 64  is a cross-sectional view taken along lines  64 - 64  of  FIG. 63 .  
         [0108]      FIG. 65  is a cross-sectional view of an alternate form of fill vial assembly of the invention.  
         [0109]      FIG. 66  is a cross-sectional view taken along lines  66 - 66  of  FIG. 65 .  
         [0110]      FIG. 67  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.  
         [0111]      FIG. 68  is a bottom plan view of the embodiment of the apparatus shown in  FIG. 67 .  
         [0112]      FIG. 69  is a top plan view of the embodiment of the apparatus shown in  FIG. 67 .  
         [0113]      FIG. 70  is a side elevational view of the vial cover portion of the apparatus shown in  FIG. 67 .  
         [0114]      FIG. 71  is a view taken along lines  71 - 71  of  FIG. 70 .  
         [0115]      FIG. 72  is a cross-sectional view taken along lines  72 - 72  of  FIG. 69 .  
         [0116]      FIG. 72A  is an enlarged, cross-sectional view of the area designated as  72 A in  FIG. 72 .  
         [0117]      FIG. 72B  is an enlarged, cross-sectional view of the elastomeric sealing band shown in  FIG. 72A .  
         [0118]      FIG. 72C  is an enlarged, cross-sectional view of the area designated as  72 C in  FIG. 72 .  
         [0119]      FIG. 72D  is an enlarged, cross-sectional view of the elastomeric sealing band shown in  FIG. 72C .  
         [0120]      FIG. 73  is a right end view of the apparatus shown in  FIG. 67 .  
         [0121]      FIG. 74  is a left end view of the apparatus shown in  FIG. 67 .  
         [0122]      FIG. 75  is a cross-sectional view taken along lines  75 - 75  of  FIG. 72 .  
         [0123]      FIG. 76  is a cross-sectional view taken along lines  76 - 76  of  FIG. 72 .  
         [0124]      FIG. 77  is a cross-sectional view taken along lines  77 - 77  of  FIG. 72 .  
         [0125]      FIG. 78  is a generally perspective, front view of the flow rate control means of this latest form of the apparatus of the present invention.  
         [0126]      FIG. 79  is a rear view of the forward most rate control plate of the flow control means shown in  FIG. 81 .  
         [0127]      FIG. 80  is a cross-sectional view taken along lines  80 - 80  of  FIG. 79 .  
         [0128]      FIG. 81  is a generally perspective, rear view of the flow rate control means shown in  FIG. 78 .  
         [0129]      FIG. 82A  is a generally perspective exploded view of the rear half of various flow rate control plates that make up the flow rate control plate assembly of the invention.  
         [0130]      FIG. 82B  is a generally perspective exploded view of the front half of various flow rate control plates that make up the flow rate control plate assembly of the invention.  
         [0131]      FIG. 83 , when considered in its entirety, comprises a front view of each of the rate control plates of the invention shown in  FIGS. 82A and 82B .  
         [0132]      FIG. 84  is a rear view of the first, or leftmost rate control plate of the rate control plate assembly shown in  FIG. 81 .  
         [0133]      FIG. 84A  is a cross-sectional view taken along lines  84 A- 84 A of  FIG. 84 .  
         [0134]      FIG. 85  is a side elevational view of the rate control plate assembly shown in  FIG. 81  as it appears in an assembled configuration.  
         [0135]      FIG. 86  is a rear view of the outlet manifold component of the assembly shown in  FIG. 85 .  
         [0136]      FIG. 87  is a cross-sectional view taken along lines  87 - 87  of  FIG. 86 .  
         [0137]      FIG. 88  is a front view of the assembly shown in  FIG. 85 .  
         [0138]      FIG. 89  is a front view of the first from the left, rate control plate or inlet manifold shown in  FIG. 82 .  
         [0139]      FIG. 90  is a front view of the rate control plate shown in  FIG. 82 .  
         [0140]      FIG. 91  is a cross-sectional view taken along lines  91 - 91  of  FIG. 90 .  
         [0141]      FIG. 92  is a front view of the second from the left, rate control plate shown in  FIG. 82 .  
         [0142]      FIG. 93  is a rear view of the rate control plate shown in  FIG. 92 .  
         [0143]      FIG. 94  is a cross-sectional view taken along lines  94 - 94  of  FIG. 93 .  
         [0144]      FIG. 95  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.  
         [0145]      FIG. 95A  is an enlarged, fragmentary cross-sectional view of the upper portion of  FIG. 95 .  
         [0146]      FIG. 95B  is an enlarged fragmentary cross-sectional view of the lower portion of  FIG. 95 .  
         [0147]      FIG. 96  is a cross-sectional view taken along lines  96 - 96  of  FIG. 95 .  
         [0148]      FIG. 97  is a cross-sectional view similar to  FIG. 96 , but showing the rate control knob rotated to a second position.  
     
    
     DESCRIPTION OF THE INVENTION  
       [0149]     Referring to the drawings and particularly to  FIGS. 1 through 10 , one embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral  102 . As best seen in  FIGS. 1 and 2 , the apparatus here comprises an outer housing  104  having first and second portions  106  and  108  respectively that can be snapped together, adhesively bonded, sonic bonded or otherwise suitably interconnected. Disposed within outer housing  104  is an inner, expandable housing  110  having a fluid reservoir  112  provided with an inlet  114  ( FIG. 3 ) for permitting fluid flow into the fluid reservoir and an outlet  116  for permitting fluid flow from the fluid reservoir. Expandable housing  110 , which can be constructed from a metal or plastic material, comprises a bellows structure having an expandable and compressible, accordion-like, annular-shaped sidewall  110   a , the configuration of which is best seen in  FIGS. 3 and 4 . As best seen in  FIG. 4 , the inner wall of the bellows is provided with a surface modification or protective coating  118  that is compatible with the fluids contained within reservoir  112 . This coating  118  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. That is, the drug interface 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. Similar drug interface coatings “C” can be provided on other surfaces, such as fluid passageways, that may be encountered by the drugs that are to be delivered (see, for example,  FIG. 37 ).  
         [0150]     Disposed within second portion  108  of outer housing  104  is the novel stored energy means of the invention for acting upon inner expandable housing  110  in a manner to cause the fluid contained within fluid reservoir  112  to controllably flow outwardly of the housing. In the present form of the invention, this important stored energy means comprises a resiliently deformable, spring  120  that is carried within the second portion  108  of the outer housing. In a manner presently to be described spring  120  is first more fully compressed by fluid flowing into reservoir  112  and then is controllably expanded to cause fluid flow from the outer housing through the dispensing means of the invention. As depicted in  FIGS. 19B through 19F  and as will be discussed in greater detail hereinafter, stored energy member  120  can be constructed in various configurations and from a wide variety of materials including metals and plastics. Preferably, spring  120  takes the form of a wave spring of the type illustrated in configuration F of  FIG. 19C  which is readily commercially available from sources, such as the Smalley Company of Lake Zurich, Ill.  
         [0151]     Typically, wave springs operate as load bearing devices. They can also take up play and compensate for dimensional variations within assemblies. A virtually unlimited range of forces can be produced whereby loads build either gradually or abruptly to reach a predetermined working height. This establishes a precise spring rate in which load is proportional to deflection, and can be tuned to a particular load requirement.  
         [0152]     Typically, a wave spring will occupy an extremely small area for the amount of work it performs. The use of this product is demanded, but not limited to tight axial and radial space restraints.  
         [0153]     Forming an important aspect of the apparatus of the present invention is fill means carried by outer housing  104  for filling the reservoir  112  with the fluid to be dispensed. As best seen in  FIG. 3 , first portion  106  includes a fluid passageway  122  in communication with inlet  114  of fluid reservoir  112 . Proximate its lower end  122   a , fluid passageway  122  communicates with a cavity  124  formed within portion  106  of the housing  104 . Disposed within cavity  124  is an elastomeric, pierceable septum  126  that comprises a part of one form of the fill means of the invention. Septum  126  is held in position by a bonded retainer  126   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  112  via passageway  122  and to recover unused medicament. The fill means can also be used to add adjuvant drugs.  
         [0154]     Forming another very important aspect of the apparatus of the present invention is a novel fluid flow control means that is disposed interiorly of outer housing  104 . This flow control means functions to precisely control the rate of fluid flow outwardly from reservoir  112  and toward the patient. In the form of the invention shown in  FIGS. 1 through 19  the flow control means comprises a flow control assembly generally designated in the drawings by the numeral  130 . As best seen in  FIGS. 11 and 12 , this novel flow control assembly here comprises an inlet manifold  132  having an inlet port  134  that is in communication with the outlet  116  of reservoir  112  and an outlet manifold  136  that is interconnected with intake manifold  132  by means of a separator plate  138 . As indicated in  FIGS. 11 and 12 , outlet manifold  136  as an outlet port  139  that is in communication with the outlet of the apparatus and is provided an elongated microchannel  140  that is in communication both with inlet port  134  and with outlet port  139  of the outlet manifold. Disposed intermediate inlet manifold  132  and a generally circular shaped separator plate  138  is filter means here provided as a filter member  142  that functions to filter fluid flowing toward outlet port  139  of the outlet manifold. Generally disk shaped filter member  142  can be formed from various porous materials, including porous poly propolene. Filter number  142  can be bonded or otherwise suitably fixed in place.  
         [0155]     As best seen in  FIG. 13 , separator plate  138  is provided with standoff ribs  144  for supporting filter member  142  in the manner shown in  FIG. 11 . The assemblage made up of inlet manifold  132 , outlet manifold  136 , separator plate  138  and filter  142  is preferably encapsulated within an outer metal or plastic casing  146  (see  FIG. 11 ).  
         [0156]     As indicated in  FIG. 11 , the flow rate control means, or assemblage  130 , has an axial centerline “CL” with which the inlet port  134  of the inlet manifold  132  is coaxial aligned. However, the outlet port  139  of the outlet manifold is radially spaced from the axial centerline. With this construction, fluid will flow from reservoir  112  into inlet port  134 , through filter member  142 , through a central opening  138   a  formed in a separator plate and thence into microchannel  140 . By controlling the length, depth and width of the microchannel  140 , the rate of fluid flow flowing outwardly of outlet  139  can be precisely controlled. In this regard, the microchannel can take several forms as, for example, those illustrated in  FIGS. 15 and 16  of the drawings and generally designated therein by the numerals  140   a  and  140   b.    
         [0157]     Turning once again to  FIGS. 1, 2  and  3 , also forming a part of the infusion apparatus of the present invention is dispensing means for dispensing fluid to the patient. In the present form of the invention this dispensing means comprises an administration set  148  that is connected to the first portion  106  of housing  104  in the manner shown in the drawings. The proximal end  150   a  of administration line  150  of the administration set  148  is in communication with an outlet fluid passageway  152  which is formed in housing portion  106  in the manner best seen in  FIG. 3 . Disposed between the proximal end  150   a  and the distal end  150   b  of the administration line is a conventional gas vent and particulate filter  156 . Provided at the distal end  150   b  is a luer connector  158  and cap  158   a  of conventional construction ( FIG. 1 ).  
         [0158]     To control fluid flow from the outlet  139  of the flow rate control means toward outlet passageway  152 , novel operating means are provided. This operating means here comprises a control knob assembly  160  that includes a finger gripping portion of  162  and a generally cylindrically shaped shank portion  164  that is rotatably received within a bore  166  formed in housing portion  106  ( FIG. 3 ). O-rings, generally designated as “O”, function to sealably interconnect the various operating components. As indicated in  FIG. 5 , control knob assembly  160  is rotatable from a first “on”, or fluid flow position, to a second “off” position as indicated by indicia provided on the forward face of housing portion  106 . The control knob assembly is retained in position within a housing  106  by a retainer ring  165 . Shank portion  164  of the control knob assembly includes an axial flow passageway  168  that communicates with the earlier identified outlet flow passageway  152  via a stub passageway  169 . The flow passageway  168  also communicates with outlet  139  of flow rate control assembly  130  when the control assembly is in the “on” position shown in  FIG. 5 . In this position, fluid it can flow from reservoir  112 , through outlet  116 , through flow rate control assembly  130 , into central passageway  168  of the control knob assembly and then toward the administration set via passageway  152 . As indicated in  FIGS. 6 and 8 , to guide the travel of the control knob assembly, the control knob assembly is provided with a protuberance  170  that travels within a groove  172  provided in the housing portion  106 .  
         [0159]     In using the apparatus of the invention, with the control knob assembly in the “off” position, the reservoir  112  of the bellows component  110  can be filled by filling means which comprises a conventional syringe having a needle adapted to pierce the pierceable septum  126  which is mounted within portion  106  of the apparatus housing. As the fluid flows into the bellows reservoir, the bellows will be expanded from a collapsed into an expanded configuration such as shown in  FIG. 3 . As the bellows member expands it will urge a telescopically movable volume indicator member  176  that is carried within a second portion  108  of the housing and in engagement with the stored energy source, or spring member  120  causing it to compress. As the reservoir  112  fills with fluid from the filling syringe, any gases trapped within the reservoir will be vented to atmosphere via vent means “V” mounted in control knob assembly  160 . A seal ring  113  ( FIG. 3 ), prevents leakage of fluid between bellows  110  and portion  106  of the housing.  
         [0160]     With the infusion apparatus interconnected with the patient&#39;s clothing by means of a spring clip assembly  184 , which is affixed to the side of the device housing in the manner shown in  FIGS. 2 and 5 , and with the administration set  148  interconnected with the patient, opening the fluid delivery path to the administration set can be accomplished by rotating the control knob from the “off” position to the “on” position. Upon opening the fluid delivery path, the stored energy means, or spring member  120 , will tend to return to its precompressed or less compressed starting configuration thereby controllably urging fluid flow outwardly of reservoir  112  via the flow rate control means of the invention, passageway  168  of the control knob assembly and delivery passageway  152  formed in housing portion  106 . As the fluid flows outwardly of the apparatus due to the urging of the stored energy means, the bellows structure  110  will be collapsed and at the same time member  176  will travel inwardly of housing portion  108 . Coupling member  176 , which forms a part of the volume indicator means of the invention, includes a radially outwardly extending indicating finger  176   a  that is visible through a volume indicator window  177  that is provided in a second portion  108  of the apparatus housing and also comprises a part of the volume indicator means of the invention ( FIG. 1  and  2 ). Indicia  179 , which are provided on indicator window  177 , function to readily indicate to the caregiver the amount of fluid remaining within bellows fluid reservoir  112 . Housing portion  106  includes an inwardly extending ullage portion  180  that functions to ensure that substantially all of the medicinal fluid contained within the bellows reservoir will be expelled therefrom.  
         [0161]     As previously discussed, a number of beneficial agents can be introduced into reservoir  112  and can be controllably dispensed 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.  
         [0162]     Referring next to  FIG. 17 , an alternate form of flow control means of the invention is there shown. This flow control means can be mounted within housing  104  in place of flow control assembly  130  and functions to precisely control the rate of fluid flow from reservoir  112  toward the patient. In the form of the invention shown in  FIG. 17 , the flow control means comprises a flow control assembly generally designated in the drawings by the numeral  180 . Flow control assembly  180  here comprises a first component or inlet manifold  180   a  having an inlet port  183  that can be placed in communication with the outlet  116  of the fluid reservoir  112  and an outlet manifold  180   b  that can be interconnected with first component  180   a  by means of a pair of separator plates or components  181  and  182 . Outlet manifold component  180   b  has an outlet port  181  that is in communication with the outlet  182   a  of separator plate  182  and also in communication with the outlet of the apparatus. Intake manifold  180   a  has an inner surface that is provided with a plurality of interconnected imbedded capillaries  184 . Capillaries  184  have input and output channels  184   a  that are in communication both with inlet port  183  and with an outlet port  185  formed in the inlet manifold. These input and output channels are typically substantially larger than the intermediate rate control channels. Disposed adjacent manifold  180   a  is separator plate  181 . Separator plate  181  has an inner surface that is also provided with a plurality of imbedded capillaries  186  that also have larger input and output channels  186   a  that are in communication with outlet port  185  formed in the inlet manifold. Fluid flowing from capillaries  184  flows into capillaries  186  via an inlet port  181   a  and then outwardly of separator plate  181  via an outlet port  181   b.    
         [0163]     Separator plate  182 , which is disposed intermediate separator plate  181  and outlet manifold  180   b , has an inner surface that is provided with a plurality of interconnected capillaries  187  that receive the fluid flowing outwardly of outlet port  181   b . After the fluid flow through capillaries  187 , it will flow toward outlet  181  of outlet manifold  180   b  via outlet port  182   a . Capillaries  187  also have larger input and output channels  187   a . The various components that make up the flow control assembly are preferably adhesively bonded together. It is to be noted that the rear surfaces of the plates are planar and cooperate with the capillaries to form fluid flow passageways.  
         [0164]     By controlling the length and depth of capillaries  184 ,  186 , and  187 , the rate of fluid flow flowing outwardly of outlet  181  can be precisely controlled. In this regard, it is to be understood that the capillaries of the flow control assembly can take several forms and be of various sizes depending upon the end use of the fluid delivery device.  
         [0165]     Thermal bonding may be performed by using a channeled plate and an adjacent planar surface plate that are of similar polymeric materials. In this case the two plates are placed in contact with one another confined mechanically and heated 2-5° C. above their glass transition temperatures. Following a holding period sufficient enough for the polymer molecules of the two surface interpenetrate with one another, the temperature is slowly reduced and a stress free bonded interface with imbedded microchannels is yielded. The bonding material or adhesive may be of the thermo-melting variety or of the liquid or light curable variety for thermo-melting adhesives, the adhesive material is melted into the two opposed surfaces, thereby interpenetrating these surfaces and creating a sealed channel structure.  
         [0166]     Liquid curable bonding materials or adhesives and light curable bonding materials or adhesives may be applied to one of the surfaces of one of the plates. Subsequently, the other surface is brought into contact with the coated surface and the adhesive is cured by air exposure or via irradiation with a light source. Liquid curable bonding materials or adhesives may be elastomeric (e.g. thermoplastic elastomers, natural or synthetic rubbers, polyurethanes and silicones). Elastomeric bonding materials may or may not require pressure to seal the channel system. They may also provide closure and sealing to small irregularities in the opposed surface of the channel system.  
         [0167]     A channel system may be formed and sealed in cases where two surfaces are being joined and one of the surfaces has one or more apertures. In order to promote bonding between these two surfaces, a vacuum may be applied to the apertures. Bonding may then be accomplished by thermal methods or after previously having applied a bonding material or adhesive.  
         [0168]     Reference should also be made to U.S. Pat. Nos. 6,182,733; 6,555,067; 6,425,972; 5,882,465; 4,999,069; and 5,376,252 which describe various bonding techniques. Reference should also be made to Publication No. WO99/56954 and WO94/29400. It should also be understood that alternate bonding techniques such as sonic welding and laser thermal bonding techniques can be used.  
         [0169]     Turning now to  FIG. 18 , still another form of flow control means of the invention is there shown. This flow control means can also be mounted within housing  104  in place of flow control assembly  130  and functions to precisely control the rate of fluid flow from reservoir  112  toward the patient. In the form of the invention shown in  FIG. 18 , the flow control means comprises a bonded-flow, laminate-stack control assembly generally designated in the drawings by the numeral  190 . Flow control assembly  190  here comprises a first component or inlet manifold  190   a  having an inlet port  191  that can be placed in communication with the outlet  116  of the fluid reservoir  112  ( FIG. 3 ) and a second component or outlet manifold  190   b  that can be interconnected with intake manifold  190   a  by means of a separator component or plates  192  and  193 . Outlet manifold  190   b  has an outlet port  194  that is in communication with the outlet  195   a  of separator plate  193  and also in communication with the outlet of the apparatus. Intake manifold  190   a  has an inner surface that is provided with a plurality of interconnected imbedded capillaries  196 . Capillaries  196  are in communication both with inlet port  191  and with an outlet port  197  formed in the inlet manifold. Disposed adjacent manifold  190   a  is the separator plate  192 . Separator plate  192  has an inner surface that is provided with a plurality of imbedded capillaries  198  that are in communication with outlet port  197  formed in the inlet manifold. Fluid flowing from capillaries  196  flows into capillaries  198  via an inlet port  197  and then outwardly of separator plate  192  via an outlet port  200 .  
         [0170]     Separator plate  195 , which is disposed intermediate separator plate  192  and outlet manifold  190   b , has an inner surface that is provided with a plurality of interconnected capillaries  201  that receive the fluid flowing outwardly of outlet port  200 . After the fluid flows through capillaries  201  it will flow toward outlet  194  of outlet manifold  190   b  via an outlet port  195   a.    
         [0171]     As before, by controlling the length, depth and width of capillaries  196 ,  198  and  201 , the rate of fluid flow flowing outwardly of outlet  194  can be precisely controlled. It is to be noted that the rear surfaces of the plates are planar and cooperate with the capillaries to form fluid flow passageways.  
         [0172]     Referring next to  FIGS. 19 and 19 A, yet another form of flow control means of the invention is there shown. This flow control means can also be mounted within housing  104  in place of flow control assembly  130  and functions to precisely control the rate of fluid flow from reservoir  112  toward the patient. In the form of the invention shown in  FIGS. 19 and 19 A, the flow control means comprises a flow control assembly generally designated in the drawings by the numeral  200 . Flow control assembly  200  here comprises a first component or inlet manifold  202  having an inlet port  202   a  that can be placed in communication with the outlet  116  of the fluid reservoir  112  and a second component or outlet manifold  204  that can be interconnected with intake manifold  202  by means of a separator component or plate  206 . Outlet manifold  204  has an outlet port  204   a  that is in communication with the outlet  206   a  of separator plate  206  and also in communication with the outlet of the apparatus. Separator plate  206  has first and second opposing surfaces  208  and  210 , each of which is provided with a plurality of interconnected, laser-etched capillaries  214 . Capillaries  214  are in communication both with inlet port  202   a  and with an outlet port  204   a  formed in the outlet manifold. As illustrated in  FIG. 19 , the inner surfaces of the inlet and outlet manifold cooperate with the capillaries to form fluid flow channels through which the medicinal fluid flows.  
         [0173]     Referring once again to  FIGS. 19B through 19F , the various types of springs suitable for use as the stored energy source of the invention are there illustrated and described. By way of background, springs are unlike other machine/structure components in that they undergo significant deformation when loaded and their compliance enables them to store readily recoverable mechanical energy.  
         [0174]     With respect to the specific spring configurations shown in the drawings, the following discussion amplifies the descriptive notations in the drawings.  
         [0000]     Compression Springs:  
         [0175]     Compression springs are open-wound helical springs that exert a load or force when compressed. They may be conical or taper springs, barrel or convex, concave or standard cylindrical in shape. Further, they may be wound in constant or variable pitch. The ends can be closed and ground, closed but unground, open and unground and supplied in alternate lengths. They also can include a configuration where a second compression spring of similar or different performance characteristics which can be installed inside the inside diameter of their first compression spring, i.e., a spring in a spring.  
         [0176]     Many types of materials can be used in the manufacture with compression springs including: Commercial Wire (BS5216 HS3), Music Stainless Steel, Phosphur Bronze, Chrome Vanadium, Monel 400, Inconel 600, Inconel X750, Nimonic 90: Round wire, Square and Rectangular sections are also available. Exotic metals and their alloys with special properties can also be used for special and applications; they include such materials as beryllium copper, beryllium nickel, niobium, tantalum and titanium.  
         [0177]     Compression springs can also be made from plastic including all thermoplastic materials used by custom spring winding service providers. Plastic springs may be used in light-to-medium duty applications for quiet and corrosion-resistant qualities.  
         [0000]     Wave Spring:  
         [0178]     Multiwave compression springs, an example of which is shown as “F” in  FIG. 19C  are readily commercially available from sources, such as the Smalley Company of Lake Zurich, Ill. As previously discussed, such springs operate as load-bearing devices. They can take up play and compensate for dimensional variations within assemblies. A virtually unlimited range of forces can be produced whereby loads built either gradually or abruptly to reach a predetermined working height. This establishes a precise spring rate in which load is proportional to deflection, and can be turned to a particular load requirement.  
         [0179]     Typically, a wave spring will occupy an extremely small area for the amount of work it performs. The use of this product is demanded, but not limited to tight axial and radial space restraints.  
         [0000]     Disc Springs:  
         [0180]     Disc springs I, J, K, and L of  FIGS. 19C and 19D  compare conically shaped annular discs (some with slotted or fingered configuration) which when loaded in the axial direction, change shape. In comparison to other types of springs, disc springs product small spring deflections under high loads.  
         [0181]     Some examples of the disc-shaped compression springs include a single or multiple stacked Belleville washer configuration as shown in G and H of  FIG. 19C , and depending on the requirements of the design (flow rate over time including bolus opportunity) one or more disc springs can be used and also of alternate individual thicknesses. Alternate embodiments of the basic disc spring design in a stacked assembly can be also utilized including specialty disc springs similar to the Belleville configuration called K disc springs manufactured by Adolf Schnorr GM8H of Singelfingen, Germany, as well as others manufactured by Christian Bauer GMBH of Welzheim, Germany.  
         [0182]     Disc springs combine high energy storage capacity with low space requirement and uniform annular loading. They can provide linear or nonlinear spring loadings with their unique ability to combine high or low forces with either high or low deflection rates. They can be preloaded and under partial compression in the design application.  
         [0183]     All these attributes, and more, come from single-component assemblies whose nontangle features (when compared to wirewound, compression springs) make them ideal for automatic assembly procedures.  
         [0184]     With respect to the various springs discussed in the preceding paragraphs, it is to be understood that many alternate materials can be used in the design and application of disc springs and include carbon steel, chrome vanadium steel, stainless steel, heat resistant steels, and other special alloys such as nimonic, inconel, and beryllium copper. In some special applications, plastic disc springs designs can be used.  
         [0185]     It should be further observed that, in comparison to other types of springs, disc springs produce small spring deflections under high loads. The ability to assemble disc springs into disc spring stacks overcomes this particular limitation. When disc springs are arranged in parallel (or nested), the load increases proportionate to the number of springs in parallel, while when disc springs are arranges in series (alternately) the travel will increase in proportion to the number of springs serially arranged. These assembly methods may be combined in use.  
         [0186]     One special feature of the disc spring is, undoubtedly, the fact that the load/deflection characteristic curve can be designed to produce a wide variety of possibilities. In addition to practically linear load/deflection characteristic curves, regressive characteristics can be achieved and even disc springs which exhibit increasing spring deflection while the corresponding disc spring load is decreasing are readily available.  
         [0187]     Slotted disc springs present a completely different case. Slotting changes the load/deflection characteristic of the single disc spring, providing larger spring deflections for greatly reduced loads. The slotted part is actually functioning as a series of miniature cantilever arms. In some cases the stacked, slotted disc spring, as shown in the clover dome design, will also produce a non-linear, stress strain curve with a noticed flat region (force/deflection). Application and use of this type of spring operating in this region will provide a near constant force between 15% and 75% of compression.  
         [0188]     As before, by controlling the length and depth and width of capillaries  214 , the rate of fluid flow flowing outwardly of outlet  204   a  can be precisely controlled.  
         [0189]     Turning next to  FIGS. 20 through 45 , an alternate embodiment of the infusion device of the present invention is there illustrated and generally designated by the numeral  221 . As best seen in  FIGS. 21A and 21B , the apparatus here comprises an outer housing  222  having first, second and third portions  222   a ,  222   b  and  222   c  respectively. Disposed within outer housing  222  is an inner, expandable housing  223  having a fluid reservoir  224  ( FIG. 22 ) provided with an inlet  224   a  ( FIG. 22 ) for permitting fluid flow into the fluid reservoir and an outlet  224   b  for permitting fluid flow from the fluid reservoir. Expandable housing  223 , which can be constructed from a metal or plastic material and can include a coating of the character previously described, comprises a bellows structure having an expandable and compressible, accordion-like, generally annular-shaped sidewall  223   a , the configuration of which is best seen in  FIGS. 21A and 21B . It is to be understood that the bellows can be constructed in various configurations and, for example, can also be generally rectangular in cross-section.  
         [0190]     Disposed within second portion  222   b  of outer housing  222  is the novel stored energy means of the invention for acting upon inner expandable housing  223  in a manner to cause the fluid contained within fluid reservoir  224  to controllably flow outwardly of the housing. In the present form of the invention, this important stored energy means comprises a compressively deformable, spring member  225  that is carried within the second portion  222   b  of the outer housing. In a manner presently to be described spring member  225  is further compressed from its initial state by fluid flowing into reservoir  224  and then is controllably expanded to cause fluid flow from the outer housing through the dispensing means of the invention. Stored energy member  225  can be constructed from a wide variety of materials including spring steel and plastic.  
         [0191]     Forming an important aspect of the apparatus of this latest form of the invention is fill means carried by the third portion  222   c  of outer housing  222  for filling the reservoir  224  with the fluid to be dispensed. As best seen in  FIG. 21A , third portion  222   c  includes a fluid passageway  226  in communication with inlet  224   a  of fluid reservoir  224 . Proximate its lower end  226   a , fluid passageway  226  communicates with a cavity  227  formed within the third portion  222   c  of the housing. Disposed within cavity  227  is an elastomeric pierceable septum  228  that comprises a part of one form of the fill means of this latest form of the invention. Septum  228  can be bonded in place and is held in position by a retainer  228   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  224  via passageway  226 . Septum  228  can comprise a conventional or a slip filling septum. Additionally, septum  228  can be replaced with a needleless check valve with luer attachments.  
         [0192]     Third portion  222   c  of housing  222  also includes a first chamber  230  for telescopically receiving a first medicament containing fill vial  232  and a second chamber  234  for telescopically receiving a second medicament containing vial  236 . An elongated support  238  is mounted within first chamber  230  and a second elongated support  240  is mounted within second chamber  234 . Each of the elongated supports  238  and  240  has an integrally threaded end portion  241  and carries a longitudinally extending, elongated hollow needle  242 . Each of the hollow needles  242  has a flow passageway  242   a  that communicates with fluid passageway  226 . First chamber  230 , second chamber  234 , elongated support  238 , elongated support  240  and hollow needles  242  together comprise an alternate form of the fill means of the apparatus of the invention. The method of operation of this alternate form of fill means will presently be described.  
         [0193]     Forming another very important aspect of the apparatus of the present invention is a novel flow control means that is connected to first portion  222   a  of outer housing  222 . This flow control means functions to precisely control the rate of fluid flow outwardly from reservoir  224  and toward the patient. In the form of the invention shown in  FIGS. 20 through 45  the flow control means comprises a flow control assembly generally designated in the drawings by the numeral  246 . This novel flow control assembly here comprises an ullage defining member  248  having a first portion  248   a  disposed within inner, expandable housing  223  and a second portion  248   b  that extends outwardly from housing  222  in the manner shown in  FIG. 21A . For a purpose presently to be described, member  248   b  has a fluid passageway  249  that is in communication with an outlet of the flow control subassembly  250 , the character of which will next be described.  
         [0194]     Referring to  FIGS. 35 through 45 , it can be seen that flow control subassembly  250 , which comprises a part of flow control assembly  256 , comprises an outer casing  252  having a plurality of circumferentially spaced-apart fluid outlets  254 , a flow control member  256  telescopically receivable within casing  252  and a selector knob  258  that is interconnected with control member  256  in the manner shown in  FIGS. 38 and 39 . An elastomeric sealing band  253 , which has the unique configuration shown in  FIGS. 21F and 21E , prevents leakage between casing  252  and member  248 . As best seen in  FIGS. 36 and 39 , flow control member  256  is uniquely provided with a plurality of elongated flow control channels  260 , each having an inlet  260   a  and an outlet  260   b . The flow channels  260  may be of different sizes, lengths and widths and in alternate configurations as shown by  FIGS. 40 and 40 A which depict alternate forms of the flow control member. The flow control member shown in  FIG. 40  is identified as  258   a , while the flow control member shown in  FIG. 40A  is identified as  258   b . Flow control member  258   b  is provided with flow channels  250   b  that are formed in spaced-apart flow segments  251 , each of which has a circuitous microfluidic flow path or micro channel of the configuration shown in  FIG. 40A . Further, the flow control channels may be rectangular in cross-section as illustrated in  FIG. 37 , or alternatively, they 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. When the flow control member is properly positioned within outer casing  252 , the inner surface of the outer casing wall cooperates with channels  260  to form a plurality of generally spiral-shaped fluid flow passageways each being of different overall length and flow capacity. When the flow control member is positioned within the outer casing, a notch  256   b  formed in member  256  receives a tongue  252   a  provided on casing  252  so as to precisely align the outlets  260   b  of the flow channels  260  with fluid outlets  254  formed in casing  252 . The various components of the flow control assembly are appropriately bonded, or otherwise sealably interconnected.  
         [0195]     The flow control channels  260  can be made by several techniques including (micro) injection molding, injection-compression molding, hot-embossing and casting. The techniques used to make these imbedded fluid channels are now common-place in the field of microfluidics, which gave rise to the lab-on-a-chip, bio-MEMS and micro-total analysis systems (m-TAS) industries. Additionally, depending on the size of the fluid channels required for a given flow rate, more conventional injection molding techniques can be used.  
         [0196]     The first step in making the channels using an injection molding or embossing process is a lithographic step, which allows a precise pattern of channels to be printed on a “master” with lateral structure sizes down to 0.05 mm. subsequently, electroforming is performed to produce the negative metal form, or mold insert. Alternatively for larger channel systems, precision milling can be used to make the mold insert directly. Typical materials for the mold insert or embossing tool are Nickel, Nickel alloys, steel and brass. Once the mold insert of embossing tool is fabricated, the polymer of choice may be injection molded or embossed to yield the desired part with imprinted channels.  
         [0197]     Alternatively, channels can also be made by one of a variety of casting processes. In general, a liquid plastic resin (e.g. a photopolymer) can be applied to the surface of a metal master (made by the techniques described above) and then cured via thermal of UV means. After hardening, the material is then “released” from the mold to yield the desired part. Additionally, there are similar techniques available that utilize CAD data (of the desired channel configuration) and direct laser curing of a liquid monomer to yield a polymerized and solidified part with imbedded channels. This process is available by contract, for example, for MicroTEC MbH of Duisburg, Germany.  
         [0198]     A number of materials can be used to fabricate flow control member  256 . While medical grade polymers are the most appropriate materials, other materials can be used including: Thermoplastics (embossing &amp; injection molding); Duroplastics (injection molding); Elastomers (injection compression molding and soft lithography); Polyurethanes (castings); and Acrylics and Epoxies (RMPDO from microTEC). Additionally, the flow control members  256  can be constructed from various metals, metal alloys, silicon, silicon dioxide and inorganic oxides.  
         [0199]     Selector knob  258 , which comprises a part of the selector means of the invention, is rotatably connected to second portion  248   b  of ullage defining member  248  and, in a manner presently to be described, functions to rotate the assembly made up of outer casing  252  and flow control member  256 . In this way, a selected outlet  254  in casing  252  can be selectively aligned with flow passageway  249  provided in the ullage defining member (see  FIGS. 21A and 21B ).  
         [0200]     Turning once again to  FIG. 20 , also forming a part of the fluid dispensing apparatus of the present invention is dispensing means for dispensing fluid to the patient. In the present form of the invention this dispensing means comprises an administration set  264  that is connected to the first portion  222   a  of housing  222  in the manner shown in the drawings. The flow channel in the proximal end  265   a  of administration line  265  of the administration set  264  is in communication with fluid passageway  249  in the manner best seen in  FIG. 21A . Disposed between the proximal end  265   a  and the distal end  265   b  of the administration line is a conventional gas vent and particulate filter  266 . Provided at the distal end  265   b  is a luer connector  268  and cap  286   a  of conventional construction.  
         [0201]     Turning now to  FIGS. 23 and 24 , the details of construction of the vial means or shell vial  270  is there shown. As indicated in these figures, each of the glass or plastic vial housings has a fluid chamber  272  for containing an injectable fluid. Chamber  272  is provided with a first open end  270   a  and second closed end  270   b . First open end  270   a  is sealably closed by closure means here provided in the form of an externally threaded, elastomeric plunger  274  which is telescopically movable within the vial from a first location shown in  FIG. 23 , where the plunger is disposed proximate first open end  270   a , to a second device-fill location where the plunger is disposed proximate second closed end  270   b.    
         [0202]     After removal of the closure  273 , which forms a part of the third portion  222   c  of housing  222  ( FIG. 22 ), vials  232  and  236  can be inserted into chambers  230  and  234  respectively. As the fill vials are so introduced and the plungers  274  are threadably interconnected with ends  241  of supports  238  and  240 , the sharp ends of the elongated needles  242  will pierce the central walls  274   a  of the elastomeric plungers. Continuous pushing movement of the vials into chambers  230  and  234  will cause the structural supports  238  and  240  to move the elastomeric plungers inwardly of the vial chambers in a direction toward the second closed end  270   b  of the vials. As the plunger is moved inwardly of the vial, the fluid contained within the vial chamber will be expelled therefrom into the hollow elongated needles  242   a . As best seen in  FIG. 21A , the fluid will then flow past elastomeric, umbrella type check valves  278  and into passageways  280  formed in third portion  222   c  of the apparatus housing. Umbrella type check valves  278  function to control fluid flow from the elongated hollow needles  242  toward fluid passageways  280 . From passageways  280  the fluid will flow into passageway  226  and then into internal fluid reservoir  224  of the bellows component  223  via ullage filling microchannels  224   a . It is to be understood that the vials  232  and  236  can contain the same or different medicinal fluids and can be introduced into their respective chambers one at a time as shown in  FIG. 22  or simultaneously as shown in  FIG. 21 .  
         [0203]     As the fluid flows into the bellows reservoir, the bellows will be expanded from the collapsed configuration shown in  FIG. 21B  into an expanded configuration, such as shown in  FIG. 22 . As the bellows member expands it will urge a telescopically movable volume indicator or coupling member  282  that is carried within the second portion of the housing in engagement with the stored energy source, or spring member  225  causing it to further compress.  
         [0204]     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  228  which is mounted within third portion  222   c  of the apparatus housing. As the reservoir  224  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  248   b  of the ullage member. This vent means here comprises a gas vent  283  that can be constructed of a suitable hydrophobic porous material such as a porous plastic. Gas vent  283  is held in position within the housing by a bonded retainer ring  283   a  ( FIG. 21A ).  
         [0205]     Upon opening the fluid delivery path to the administration set  264  in a manner presently be described, the stored energy means, or member  225 , will tend to return to its initial starting, less compressed configuration thereby controllably urging fluid flow outwardly of reservoir  224  via the flow control means of the invention.  
         [0206]     As previously discussed a number of beneficial agents can be contained within vials  232  and  236  and can be controllably dispensed to the patient including, by way of example, liquid injectable 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.  
         [0207]     Considering next the operation of the flow rate control means of the invention, as the fluid contained within the bellows reservoir  224  is urged outwardly thereof by the stored energy means, the fluid will flow into a fluid passageway  284  formed in the first portion  248   a  of ullage member  248 . The fluid will then flow under pressure through a filter means shown here as a filter  286  that is peripherally bonded within a cavity provided in the flow control member  256  of the flow control subassembly  250 . Filter  286 , which functions to filter particulate matter from the fluid flowing outwardly from reservoir  224  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  286 , the fluid will flow, via a stub passageway  288  ( FIG. 21A ) into the distribution means of the invention for distributing fluid from the fluid reservoir to each of the plurality of spiral passageways  260 . This distribution means here comprises several radially outwardly extending flow passageways  290  formed in flow control member  256 . The filtered fluid will fill passageways  290  and then will flow into the plurality of spiral passageways  260  formed in member  256  via outlets  260   b , which communicate with passageways  260  (see  FIG. 39 ). The fluid contained within spiral passageways  260  can flow outwardly of the device via outlets  260   b  only when one of the fluid outlets  254  formed in casing  252  is aligned with reservoir outlet passageway  249  ( FIG. 21A ).  
         [0208]     Selection of the passageway  260  from which the fluid is to be dispensed is accomplished by rotation of the selector knob  258  which, as best seen in  FIG. 39 , includes a reduced diameter portion  258   a  having a slot  258   b  formed therein. As illustrated in  FIG. 36 , slot  258   b  is adapted to receive a spline  256   a  ( FIG. 36 ) formed anteriorly of member  256 . With this construction, rotation of selector member  258  by gripping a transversally extending finger gripping member  258   g  will impart rotation to member  256 . As seen in  FIG. 39 , casing  252  is also provided with an inwardly extending spline segment  252   a  that is received within a slot  256   b  formed in the rearward periphery of member  256  ( FIG. 38 ). Accordingly, rotation of member  256  will also impart concomitant rotation to casing member  252 .  
         [0209]     As illustrated in  FIGS. 35 and 39 , selector knob  258  is provided with a plurality of circumferentially spaced apart indexing cavities  258   c  that closely receive an indexing finger  294  which forms a part of the indexing means of the invention, which means comprises a locking shaft cover  296  that is connected to third portion  222   c  of the apparatus housing (see  FIGS. 20 and 21 A). Indexing finger  294  is continuously urged into engagement with a selected one of the indexing cavities  258   c  by a coil spring  298  that also forms a part of the indexing means of the invention. Coil spring  298  can be compressed by an inward force exerted on an indexing shaft  300  that is mounted in locking shaft cover  296  and is movable from the extended position shown in  FIG. 21A  to an inward, finger release position wherein spring  298  is compressed and finger  294  is retracted from a selected indexing cavity  258   c  (see also  FIGS. 30, 31  and  32 ). With finger  294  in its retracted position it is apparent that control knob  258  can be freely rotated to a position wherein flow rate indicia  304  formed on the periphery of knob  258  ( FIG. 35 ) can be viewed through a viewing window  305  formed in the first portion  206  of the apparatus housing. Locking means, here provided in the form of a locking member  310  (see  FIG. 29 ), is also carried by the locking shaft cover and, when moved from the release position shown in  FIG. 33  into the locking position shown in  FIG. 34 , prevents inward movement of the indexing shaft  300  against the urging of spring  298 . A spring biased retainer pin  311  ( FIG. 31 ) functions to retain the selector knob in position within housing  222   a.    
         [0210]     When the selector knob is in the desired position and pressure is released on indexing shaft  300 , spring  298  will urge finger  294  of the indexing means of the invention into locking engagement with one of the indexing cavities  258   c  thereby placing a selected one of the spiral shaped flow control channels  260  in communication with the fluid reservoir  224  via passageways  290 ,  288  and  284 . As the fluid flows outwardly of the apparatus due to the urging of the stored energy means or spring member  225 , the bellows structure  223  will be collapsed and at the same time member  282  will travel inwardly of housing portion  222   b . Coupling member  282 , which forms a part of the volume indicator means of the invention, includes a radially outwardly extending indicating finger  282   a  that is visible through a volume indicator window  313  that is provided in a second portion  222   b  of the apparatus housing and also comprises a part of the volume indicator means of the invention ( FIG. 20 ). Indicia  315 , which are provided on indicator window  313 , function to readily indicate to the caregiver the amount of fluid remaining within fluid reservoir  224 .  
         [0211]     Safety disabling means, shown here as a disabling shaft  318  that is telescopically movable within a passageway  320  formed within housing portion  222   a  functions to disable the device ( FIG. 22A, 28A ), by occluding the output passageway  249 . More particularly, shaft  318  has a distal end  318   a , which, upon insertion of the shaft, will block fluid flow through passageway  249 . A retainer  318   b  normally holds shaft  318  in the retracted position (see  FIG. 22A ).  
         [0212]     Referring now to  FIGS. 46 through 52 , yet another embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral  330 . This alternate form of the apparatus of the invention is similar in many respects to that shown in  FIGS. 20 through 45  and like numerals are used in  FIGS. 46 through 52  to identify like components. The primary difference between this latest form of the invention and the invention shown in  FIGS. 20 through 45  resides in the fact that two cartridge fill vials of a different construction are used to fill the fluid reservoir of the apparatus. As before, the apparatus of this alternate form of the invention comprises an outer housing  332  having first, second and third portions  334 ,  336 , and  338  respectively. Disposed within outer housing  332  is an inner, expandable housing  223  that is of identical construction and operation to the expandable housing of the embodiment of the invention shown in  FIGS. 21A and 21B . As in the earlier described embodiment, housing  223  includes a fluid reservoir that is provided with an inlet  224   a  ( FIG. 47 ) for permitting fluid flow into the fluid reservoir. As shown in  FIG. 47 , expandable housing  223  comprises a bellows structure having an expandable and compressible, accordion-like side wall  223   a , which is suitably bonded at its open end  223   b  to member  370   b.    
         [0213]     Disposed within second portion  336  of outer housing  332  is the stored energy means of the invention for acting upon inner expandable housing  223  in a manner to cause the fluid contained within the fluid reservoir to controllably flow through outlet  376 . In this alternate form of the invention, the important stored energy means is identical in construction and operation to the earlier described stored energy means and here comprises a compressively deformable, wave spring member  225  that is carried within the second portion  336  of the outer housing. As before, in operation member  225  is first more fully compressed by fluid flowing into the reservoir and then is controllably unloaded or expanded to cause fluid flow from the reservoir.  
         [0214]     As in the last described embodiment of the invention, the apparatus of this alternate form of the invention comprises fill means carried by the third portion  338  of outer housing  332  for filling the reservoir with the fluid to be dispensed. This fill means is also similar to the earlier described fill means, save for the fact that the fill means of this latest embodiment comprises a pair of glass or plastic fill vials or cartridges  342  which each are of identical construction. As in the earlier described embodiments, the fill means also includes an alternate fill means that comprises a pierceable septum  344  that is disposed within a cavity  346  formed in the third portion  338  of outer housing  332 . Elastomeric septum  344  is pierceable by the needle of the syringe which contains the medicinal fluid to be dispensed and which can be used to fill or partially fill the fluid reservoir via a passageway  348  formed in third portion  338 .  
         [0215]     As best seen in  FIG. 47 , third portion  338  of housing  332  includes a pair of spaced-apart chambers  350  for telescopically receiving the medicament containing fill vials  342 . As shown in  FIGS. 47 and 51  a pair of elongated supports  354  are mounted within a hollow vial cover  356  that forms a part of the third portion  338  of the housing and removably covers the fill vials in the manner shown in  FIG. 47 . Each of the fill vial cartridges  342 , is of the generally conventional pharmaceutical industry construction shown in  FIGS. 50 and 50 A, and each comprises a hollow glass or plastic body portion  358  that defines a fluid chamber  360 . Each fill vial has an open first end  342   a  and a second end that is closed by a pierceable, elastomeric septum  362  that is held in place by a mechanical clamping ring. Mounted proximate the inboard end of each chamber  350  is a hollow needle  364  which is adapted to pierce septum  362  when the fill vials are inserted into chambers  350  in a manner next to be described.  
         [0216]     Disposed within each vial reservoir  360  is a plunger  366  that is moved by a support  354  of vial cover  356  from a first position proximate end  342   a  of the vial to a second position. More particularly, as the vial cover  356  is mated with the apparatus housing, the inboard end of each of the elongated supports  354  engages a plunger  366  urging the plunger inwardly of the vial chamber  360 . As each of the plungers move inwardly of their respective vial reservoirs, the fluid contained in the reservoir will be forced through hollow needle  364 , passed an umbrella check valve  368  mounted within third housing portion  338 , into a stub passageway  370 , into a passageway and finally into fluid reservoir via inlet  224   a . As the fluid flows into the reservoir, it will more fully compress the stored energy means in the manner previously described.  
         [0217]     The apparatus of this latest form of the invention also includes flow control means that is quite similar in construction and operation to the flow control means described in connection with the embodiment of the invention shown in  FIGS. 20 through 45 . This flow control means is connected to first portion  334  of outer housing  332  and comprises an ullage defining member  370  having a first portion  370   a  disposed within inner, expandable housing  223  and a second portion  370   b  having a fluid passageway  372  that is in communication with outlet  376  of the fluid reservoir.  
         [0218]     As before, the flow control means includes a flow control subassembly that is substantially identical in construction and operation to the earlier described flow control subassembly  250  and is of the configuration shown in  FIGS. 35 through 45  of the drawings. For this reason, the details of the construction and operation of the flow control means of this latest embodiment of the invention will not be here repeated and reference should be made to the earlier description of the flow control subassembly  250 .  
         [0219]     Turning once again to  FIG. 46 , 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 identical in construction and operation to the previously identified administration set  264  and is connected to the first portion  334  of housing  332 .  
         [0220]     Upon opening the fluid delivery path to the administration set  264 , the stored energy means, or member  225 , will tend to return to its less compressed starting configuration thereby controllably urging fluid flow outwardly of the device reservoir via the flow control means of the invention. As the fluid contained within the bellows reservoir is urged outwardly thereof by the stored energy means, the fluid will flow into a fluid passageway  376  formed in the first portion  370   a  of ullage member  370 . The fluid will then flow under pressure through a filter means shown here as a filter  286  that is identical to that previously described. After flow through filter  286 , the fluid will flow, via a stub passageway  378  ( FIG. 47 ) into the several radially outwardly extending flow passageways  290  formed in flow control member  256 . The filtered fluid will fill passageways  290  and then will flow into the plurality of spiral passageways  260  formed in member  256  via outlets  254 , which communicate with passageways  260  (see  FIG. 36 ). The fluid contained within spiral passageways  260  can flow outwardly to the patient via the administration line only when one of the fluid outlets  254  formed in casing  252  is aligned with passageway  372  ( FIG. 47 ).  
         [0221]     Selection of the passageway  260  from which the fluid is to be dispensed is accomplished by rotation of the selector knob  258  in the manner previously described in connection with the embodiment shown in  FIGS. 20 through 45 . The construction and operation of the selector knob, the indexing means and the locking means is identical to that previously described and will not be redescribed at this time.  
         [0222]     As in the earlier described embodiment of the invention, as the fluid flows outwardly of the apparatus due to the urging of the stored energy means or spring member  225 , the bellows structure  223  will be collapsed and at the same time coupler member  282  will travel inwardly of housing portion  336  and will provide an indication of the volume of fluid remaining in the fluid reservoir in the same manner as earlier described.  
         [0223]     This latest embodiment also includes safety disabling means  318 , which is substantially identical in construction and operation to that previously described.  
         [0224]     Turning now to  FIGS. 53 through 66 , still another form of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral  380 . This alternate form of the apparatus of the invention is similar in some respects to that shown in  FIGS. 46 through 52  and like numerals are used in  FIGS. 53 through 66  to identify like components. The primary difference between this latest form of the invention and the invention shown in  FIGS. 46 through 52  resides in the fact that one of the two fill vials used to fill the fluid reservoir of the apparatus is of totally different construction. More particularly, one of the fill vials is specially designed to enable the reconstitution and intermixing of a contained lypholized drug with a suitable reconstitution agent prior to the delivery of the mixture to the fluid reservoir of the device. The second cartridge will typically carry a diluent to add to the first now injectable drug in residence in the reservoir.  
         [0225]     As in the earlier described embodiments, the apparatus of this latest form of the invention comprises an outer housing  382  having first, second and third portions  384 ,  386  and  388  respectively. Disposed within outer housing  382  is an inner, expandable housing  223  that is of identical construction and operation to the expandable housing of the embodiment of the invention shown in  FIGS. 46 through 52 . As in the earlier described embodiment, housing  382  includes a fluid reservoir that is provided with an inlet  216  ( FIG. 54 ) for permitting fluid flow into the fluid reservoir. As shown in  FIG. 54 , expandable housing  223  comprises a bellows structure having an expandable and compressible, accordion like sidewall  223   a.    
         [0226]     Disposed within second portion  386  of outer housing  382  is the stored energy means of the invention for acting upon inner expandable housing  223   a  in a manner to cause the fluid contained within the fluid reservoir of the device to controllably flow through outlet  374 . In this latest form of the invention, the important stored energy means is identical in construction and operation to the earlier described stored energy means and here comprises a compressively deformable, spring member  225  that is carried within the second portion  386  of the outer housing. As before, in operation member  225  is first more fully compressed by fluid flowing into the device reservoir and then is controllably unloaded or expanded to cause fluid flow from the reservoir.  
         [0227]     As previously mentioned, the apparatus of this latest form of the invention comprises fill means of a somewhat different construction, that is, carried by the third portion  388  of outer housing  382  for filling the device reservoir with the fluid to be dispensed. This fill means, like the last described fill means, comprises a pair of fill vials or cartridges, one of which, namely fill vial  342 , is of identical construction and operation to the earlier described fill vial  342 . The second fill vial or cartridge designated by the numeral  392  comprises a container of special design that uniquely contains a lyophilized drug  394  that is separated from a reconstituting fluid  396  by a barrier stopper  398  ( FIG. 61 ). Lyophilized drug  394  can, by way of example, comprise an anti-infective, an oncolytics agent, a cardiac drug or various other types of beneficial agents. Cartridge  392  is telescopically receivable within a vial housing  400  that is of the configuration shown in  FIGS. 54, 58  and  60 . As before, vial housing  400  includes a pair of spaced apart pusher members  402  and  404  which engage plungers  366  ( FIG. 63 ) and  406  ( FIG. 61 ) respectively to push the plungers forwardly of their respective container reservoirs.  
         [0228]     Considering in more detail the novel cartridge assembly  392 , as best seen in  FIG. 61 , this cartridge assembly includes a vial  408  that is sealed at one end by a plunger  406  and at the other end by a pierceable septum  410  ( FIG. 61 ) that is held in place by a suitable crimp ring. Formed intermediate the ends of vial  408  is a raised outer wall portion  408   a  which permits fluid  396  to bypass elastomeric barrier stopper  398  as the barrier stopper is urged inwardly of the container by pressure exerted thereon by the fluid  396 . Fluid  396  exerts pressure on barrier member  398  as a result of pusher member  404  exerting inward pressure on plunger  406 , which pressure is, in turn, caused by the inward movement of plunger  406  as the vial housing is mated with and advanced within the apparatus housing  382 .  
         [0229]     A continued inward pressure exerted on plunger  406  will cause fluid  396  to flow past barrier member  398  via wall portion  408   a  so as to reconstitute lyophilized drug  394  with an internally contained reconstitution agent  396 . Further pressure exerted on plunger  406  will cause the reconstituted drug formed by the fluid  396  which has been intermixed with drug  394  to flow through a hollow cannula  412 , past check valve  414 , into a stub passageway  416  and then into a passageway  418  and finally into the device reservoir via ullage microchannels  420 .  
         [0230]     As previously mentioned, plunger  406  is disposed within vial  392  and is moved by a support  404  of vial closure  400  as the vial cover is mated with the apparatus housing. As plunger  366  is moved inwardly of vial reservoir  360 , the fluid contained in the reservoir will be forced through hollow needle  412   a , passed an umbrella check valve  414   a  mounted within third housing portion  388 , into a stub passageway  416 , into a passageway  418  and finally into the device reservoir via ullage reservoir filling channel  420 . As the fluid flows into the device reservoir, it will more fully compress the stored energy means in the manner previously described.  
         [0231]     As in the earlier described embodiments, the fill means also includes an alternate fill means that comprises a mechanical check valve (not shown) or an elastomeric pierceable septum  344  that is disposed within a cavity  346  formed in the third portion  388  of outer housing  382 . Septum  344  is pierceable by the needle of the syringe which contains the medicinal fluid to be dispensed and which can be used to fill or partially fill the device reservoir via passageway  418  formed in third portion  388 .  
         [0232]     The apparatus of this latest form of the invention also includes flow control means that is identical in construction and operation to the flow control means described in connection with the embodiment of the invention shown in  FIGS. 36 through 45 . This flow control means is connected to first portion  384  of outer housing  382  and comprises an ullage defining member  370  having a first portion  370   a  disposed within inner, expandable housing  223  with which the bellows slidably cooperates and a second portion  370   b  having a fluid passageway  372  that is in communication with outlet  374  of the device reservoir. Once again, the ullage defining member functions to ensure that substantially all of the medicament is dispensed from the fluid reservoir.  
         [0233]     As before, the flow control means includes a flow control subassembly that is substantially identical in construction and operation to the earlier described flow control subassembly  250  and is of the configuration shown in  FIGS. 36 and 38  of the drawings. For this reason, the details of the construction and operation of the control means of this latest embodiment of the invention will not be here repeated and reference should be made to the earlier description of the flow control subassembly  250 .  
         [0234]     Turning once again to  FIG. 53 , 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 identical in construction and operation to the previously identified administration set  264  and is connected to the first portion  384  of housing  382 .  
         [0235]     Upon opening the fluid delivery path to the administration set  264  in the manner previously described, the stored energy means, or member  225 , will tend to return to its less compressed starting configuration thereby controllably urging fluid flow outwardly of the device reservoir via the flow control means of the invention. As the fluid contained within the reservoir is urged outwardly thereof by the stored energy means, the fluid will flow into a fluid passageway  374  formed in the first portion  370   a  of ullage member  370  ( FIG. 54 ). The fluid will then flow under pressure through a filter means shown here as a filter  286  that is identical to that previously described. After flowing through filter  286 , the fluid will flow, via a stub passageway  288  ( FIG. 54 ) into the several radially outwardly extending flow passageways  290  formed in flow control member  256  ( FIG. 44 ). The filtered fluid will fill passageways  290  and then will flow into the plurality of spiral passageways  260  formed in member  256  via outlets  260   b , which communicate with passageways  260  (see  FIG. 36 ). The fluid contained within spiral passageways  260  can flow outwardly of the device only when one of the fluid outlets  254  formed in casing  252  is aligned with passageway  372  ( FIG. 54 ).  
         [0236]     Selection of the passageway  260  from which the fluid is to be dispensed is accomplished by rotation of the selector knob  258  in the manner previously discussed in connection with the earlier described embodiments. The construction and operation of the selector knob, the indexing means and the locking means is identical to that previously described and will not be redescribed at this time.  
         [0237]     As in the earlier described embodiments of the invention, as the fluid flows outwardly toward the patient via the administration set  264  due to the urging of the stored energy means or spring member  225 , the bellows structure  223  will be generally collapsed and at the same time member  282  will travel inwardly of housing portion  386  and will provide an indication of the volume of fluid remaining in the fluid reservoir in the same manner as earlier described.  
         [0238]     This latest embodiment also includes safety defeat disabling means  318 , which is substantially identical in construction and operation to that previously described.  
         [0239]     Considering next the alternate form of fill cartridge assembly  422 , shown in  FIG. 65 . This fill cartridge is similar in some respects to fill cartridge  392  and includes a vial  424  that is sealed at one end by a plunger  425  and at the other end by an elastomeric pierceable septum  428 . Formed intermediate the ends of vial  424  is a plurality of internal fluid flow passageways  430  which permit fluid  432  to bypass a strategically position barrier stopper  434  as the barrier stopper is urged inwardly of the container by pressure exerted thereon by fluid  432 . Fluid  432  exerts pressure on barrier member  434  as a result of pusher member  404  of the vial housing  400  exerting inward pressure on plunger  425 , which pressure is, in turn, caused by the inward movement of plunger  434  as vial housing  400  is mated with the housing  382  as is advanced therewithin.  
         [0240]     A continued inward pressure exerted on plunger  425  will cause fluid  432  to flow past elastomeric barrier member  434  via internal bypass flow channels  430  so as to reconstitute lyophilized drug  433  ( FIG. 65 ). Further pressure exerted on plunger  425  will advance plunger  434  to a more and subsequently fully distal location which will cause the reconstituted drug formed by the fluid  432  which has been intermixed with drug  433  to flow through a hollow cannula  412  past elastomeric check valve  414 , into a stub passageway  416  and then into a passageway  418  and finally into the device reservoir via filling channel  420  ( FIG. 54 ).  
         [0241]     Referring now to  FIGS. 67 through 97 , yet another embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral  442 . This alternate form of the apparatus of the invention is similar in some respects to the previously described embodiments of the invention and like numerals are used in  FIGS. 67 through 97  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 stored energy means and of a differently configured flow rate control means. Further, the reservoir fill means of this latest form of the invention includes only a single, cartridge type fill vial.  
         [0242]     As best seen in  FIG. 67 , the apparatus here comprises an outer housing  442  having first, second and third portions  446 ,  448  and  449  respectively. Disposed within outer housing  442  is an inner, expandable housing  450 , which is generally similar in construction and operation to expandable housing  223 , which housing was described in connection with the embodiment of  FIG. 21 .  
         [0243]     Also disposed within outer housing  442  is the novel stored energy means of the invention for acting upon inner expandable housing  450  in a manner to cause the fluid contained within the fluid reservoir thereof to controllably flow outwardly of the housing ( FIG. 72 ). In this latest form of the invention, this stored energy means comprises a plurality of cooperatively associated disk springs  453 . These disk springs, exhibit superior load/deflection curves and are ideally suited for use in the present application. Springs  453  are readily commercially available from a number of sources including the Schnorr Co. of Sindelfingen, Germany.  
         [0244]     As in the earlier described embodiments of the invention, the present invention includes fill means, which are here carried by the third portion  449  of the outer housing. As before, the fill means functions to fill the device reservoir that is defined by bellows member  450  with the fluid to be dispensed. As best seen in  FIGS. 67, 68  and  72  third housing portion  449  includes a fluid passageway  454  that is in communication with the inlet or passageway  456  of fluid reservoir. Proximate its lower end  454   a  fluid passageway  454  communicates with a cavity  457  formed within the third portion of the housing. Disposed within cavity  457  is a pierceable septum  458  that comprises a part of the fill means of this latest form of the invention. Septum  458  is held in position by a retainer  458   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  454 . As the reservoir fills, and gases trapped within the reservoir will be vented via vents “V”.  
         [0245]     The fill means also here comprises a cartridge type fill vial  460  which is of the construction shown in  FIG. 72 . As shown in  FIG. 72 , the third portion  449  of the housing includes a chamber  462  for telescopically receiving cartridge fill vial  460 . A hollow needle  464  is mounted within third portion  449  of the device housing and is located proximate the inboard end of chamber  462 . When the cartridge fill vial  460  is inserted into chamber  462  and pushed forwardly into the position shown in  FIG. 72 , hollow needle  464  will pierce a septum  466  that sealably closes the open end of the cartridge fill vial.  
         [0246]     As illustrated in  FIGS. 70, 71  and  72 , the vial cover  469  of portion  449  of the device housing includes a pusher member  471  which engages a plunger  474  of vial  460  when the vial cover is mated with the device housing. Pusher member  471  functions to push the plunger forwardly of container reservoir  476  as the vial cover  469  is moved into the fully mated position shown in  FIG. 72 . As plunger  474  is moved forwardly of reservoir  476 , the fluid contained in the vial reservoir will be forced through hollow needle  464 , passed a conventional umbrella check valve  480  that is mounted within third housing portion  449 , into a stub passageway  482 , into passageways  454  and  456  and finally into the device reservoir. As the fluid flows into the device reservoir, it will controllably compress the stored energy means, or disc springs  453 .  
         [0247]     Turning particularly to  FIGS. 78 through 97 , 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 outwardly rate of fluid flow from the device reservoir 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  484 . This flow rate control assembly is non-rotatably mounted within housing portion  446  and includes an elongated spline  485  that functions to align the assembly within the outer housing. As best seen in  FIGS. 72 and 81 , this novel flow rate control assembly here comprises an inlet manifold  486  having an inlet port  488  ( FIG. 72 ) that is in communication with the outlet  489  of the fluid reservoir and an outlet manifold  490  that is interconnected with inlet manifold  486  by means of a plurality of interconnected flow rate control plates  492 ,  494 ,  496 ,  498 ,  500 ,  502 , 504 ,  506 ,  508  and  510  (see also  FIGS. 82A and 82B ).  
         [0248]     As indicated in  FIGS. 79, 80  and  85 , outlet manifold  490  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  514  of the apparatus and with the administration line  150  of the administration set  148  ( FIG. 72 ).  
         [0249]     As best seen by referring to  FIGS. 82A and 82B , 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. 82A and 82B , 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  488  can controllably flow. As indicated in the drawings, one end of each of the micro channels is in communication with the inlet port  488  of the inlet manifold  486  via a center port  489  and the other end of each of the micro channels is in communication with a selected one of the circumferentially spaced outlet ports provided in the outlet manifold  490 . More particularly, as can be seen by referring to  FIGS. 82A, 82B ,  83  and  88  of the drawings, outlet  492   a  of rate control plate  492  is in communication with outlet  521  of outlet manifold  490 ; outlet  494   a  of rate control plate  494  is in communication with outlet  522  of outlet manifold  490 ; outlet  496   a  of control plate  496  is in communication with outlet  523  of manifold  490 ; outlet  498   a  of control plate  498  is in communication with outlet  524  of outlet manifold  490  and outlet  500   a  of rate control  500  is in communication with outlet  525  of outlet manifold  490 , and outlet  502   a  of rate control plate  502  is in communication with outlet  526  of outlet manifold  490 . In similar fashion, outlet  504   a  of rate control plate  504  is in communication with outlet  527  of outlet manifold  490 ; outlet  506   a  of rate control plate  506  is in communication with outlet  528  of manifold  490 ; outlet  508   a  of control plate  508  is in communication with outlet  529  of outlet manifold  490  and outlet  510   a  of rate control plate  510  is in communication with outlet  530  of outlet manifold  490 .  
         [0250]     With the construction of the flow control means shown in the drawings, fluid will flow from the device reservoir into inlet port  488  of inlet manifold  486 , through a filter member  533  ( FIG. 85 ) and thence into micro channel  534  formed in plate  492 . By controlling the length, width and depth of the micro channel  534 , the rate of fluid flow flowing outwardly of outlet  492   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  534  can take various forms and can be of varying length, width and depth to precisely control the rate of fluid flow their through.  
         [0251]     Fluid flowing through inlet port  488  will also flow into micro channel  536  formed in rate control plate  494 . Once again, depending upon the length, width and depth of micro channel  536 , the rate of fluid flowing outwardly of outlet  494   a  can be precisely controlled. In similar manner, fluid flowing through inlet port  488  will fill micro channel  538  formed in rate control plate  496 , will fill micro channel  540  formed in plate  498 , will fill micro channel  542  formed in rate control plate  500 , will fill rate control micro channel  544  formed in rate control plate  502 , will fill rate control micro channel  546  formed in rate control plate  504 , will fill rate control micro channel  548  formed in rate control plate  506 , will fill flow control micro channel  550  formed in rate control plate  508  and will fill rate control micro channel  552  formed in rate control plate  510 . 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  490  and will fill each of the stub passageways  555  formed therein ( FIG. 87 ). 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.  
         [0252]     As shown in  FIGS. 72 and 76 , a selector knob  558  which is sealably rotatably connected to first portion  446  of the outer housing, is provided with a plurality of circumferentially spaced apart indexing cavities  559 . Elastomeric sealing bands  558   c  and  558   d , which are of the unique configuration shown in  FIGS. 72B and 72D , prevent leakage between the cooperatively mated components. These indexing cavities closely receive an indexing finger  560 , which forms a part of the indexing means of the invention, which means comprises a front bezel  562  that is connected to the apparatus housing (see  FIG. 67 ). Indexing finger  560  is continuously urged into engagement with a selected one of the indexing cavities  559  by a coil spring  564  that also forms a part of the indexing means of the invention. Coil spring  564  can be compressed by an inward force exerted on an indexing shaft  566  that is movable from an extended position to an inward, finger release position wherein spring  564  is compressed and finger  560  is retracted from a selected indexing cavity  559 . With finger  560  in its retracted position, it is apparent that control knob  558  can be freely rotated to a position wherein a gripping member  558   a  can be aligned with selected flow rate indicia  568  formed on the front bezel  562  of the apparatus housing.  
         [0253]     When the selector knob is in the desired position and pressure is released on indexing shaft  566 , spring  564  will urge finger  560  of the indexing means of the invention into locking engagement with one of the indexing cavities  559  thereby placing a selected one of flow control channels of a flow rate control plate in communication with flow passageway  558   b  of the flow control knob ( FIG. 81 ). As the fluid flows outwardly of the apparatus due to the urging of the stored energy means or spring members  453 , the bellows structure  450  will be collapsed and at the same time and indicator member  569  will travel inwardly of the housing. Member  569 , which forms a part of the volume indicator means of the invention, includes a radially outwardly extending indicating finger  569   a  that is visible through a volume indicator window  570  that is provided in a second portion  448  of the apparatus housing and also comprises a part of the volume indicator means of the invention. Indicia  571 , which are provided on indicator window  570  ( FIG. 69 ), function to readily indicate to the caregiver the amount of fluid remaining within fluid reservoir of the device at any point in time.  
         [0254]     Referring to  FIGS. 67 and 77 , disabling means, shown here as a disabling shaft  574  that is telescopically movable within a passageway formed within housing portion, functions in the manner previously described to disable the device (see discussion concerning  FIG. 22A ).  
         [0255]     Referring particularly to  FIG. 95 , selector knob  558  (see also  FIGS. 78 and 81 ), which comprises a part of the selector means of the invention, is sealably connected to outlet manifold  490  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  490  toward the administration set  150 . More particularly, as illustrated in  FIGS. 95, 95A  and  95 B, selector knob  558  is provided with a circumferentially extending flow channel  578  which is selectively in communication with passageways  555  of outlet manifold  490  depending upon the position of the selector knob. As illustrated in  FIGS. 95A and 95B , the rearwardly-extending, generally-cylindrical, reduced-diameter portion  558   d  of the control knob, which circumscribes the outlet manifold  490 , is provided with a circumferentially extending, elastomeric band  582  which prevents fluid leakage between the outlet manifold and the flange  558   d . Outlet manifold  490  is also provided with a similarly configured, circumferentially extending, elastomeric band  584 . As indicated in  FIG. 95A , elastomeric band  584  has an opening  584   a  that is in alignment with fluid outlet passageway  514  formed in the first portion  446  of the outer housing (see also  FIG. 72 ). Elastomeric band  582  also has an opening  582   a  which is aligned with a radially extending flow passageway  578   b  formed on portion  558   d  of the control knob, which, in turn, is in communication with circumferentially extending flow channel  578  ( FIG. 95A ). With this construction, when the control knob  558  is rotated to a position such as that illustrated in  FIG. 95A , wherein one of the outlets of the outlet manifold is in alignment with the opening  582   a  formed in the elastomeric band  582 , fluid can flow from that outlet and into circumferentially extending flow channel  578 . From flow channel  578 , the fluid can flow into radially extending passageway  578   b , through opening  584   a  and into passageway  514 . From passageway  514 , the fluid can flow onwardly into the dispensing means or administration set  148 . 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  578   b  formed in the control knob. By way of example, with the control knob  558  in the position shown in  FIG. 95A , it is to be observed that the fluid flowing toward the administration set is flowing from outlet  492   a  of rate control plate  492  and will flow at a rate determined by the configuration of rate control micro channel  534 . (see  FIGS. 82 and 96 ).  
         [0256]     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 of 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.