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 compressible-expandable elastomeric member of novel construction 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 the medicament solution to the patient.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This is a Divisional application of co-pending U.S. Ser. No. 10/855,436 filed May 26, 2004. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not Applicable 
       INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC 
       [0003]    Not Applicable 
       BACKGROUND OF THE INVENTION 
       [0004]    1. Field of the Invention 
         [0005]    The present invention relates generally to fluid delivery 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 energy source, a novel fill means for filling the reservoir of the apparatus and a unique, adjustable, multichannel flow rate control means for precisely adjustably controlling the rate of fluid flow from the reservoir of the device. 
         [0006]    2. Description of Related Art Including Information Disclosed Under 37 CFR 1.97 and 1.98 
         [0007]    A number of different types of medicament dispensers for dispensing medicaments to ambulatory patients have been suggested. Many of the devices seek either to improve or to replace the traditional gravity flow and hypodermic syringe methods which have been the standard for delivery of liquid medicaments for many years. 
         [0008]    The prior art gravity flow methods typically involve the use of intravenous administration sets and the familiar flexible solution bag suspended above the patient. Such gravimetric methods are cumbersome, imprecise and require bed confinement of the patient. Periodic monitoring of the apparatus by the nurse or doctor is required to detect malfunctions of the infusion apparatus. 
         [0009]    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. 
         [0010]    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. 
         [0011]    As will be appreciated from the discussion which follows, the apparatus of the present invention is uniquely suited to provide precise fluid delivery management at a low cost in those cases where a variety of precise dosage schemes 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 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. 
         [0012]    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. 
         [0013]    By way of summary, the apparatus of the present invention uniquely overcomes the drawbacks of the prior art by providing a novel, disposable dispenser of simple but highly reliable construction. A particularly important aspect of the apparatus of the present invention resides in the provision of a novel, self-contained energy source in the form of a substantially constant-force compressible-expandable elastomeric member that provides the force necessary to uniformly and precisely 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. 
         [0014]    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. 
         [0015]    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 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. 
         [0016]    Another important prior art fluid delivery device is described in 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. 
         [0017]    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. 
       BRIEF SUMMARY OF THE INVENTION 
       [0018]    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. 
         [0019]    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 injectable fluid. 
         [0020]    Another object of the invention is to provide a dispenser in which a stored energy source is provided in the form of a substantially constant-force, compressible-expandable elastomeric member of novel construction that provides the force necessary to continuously and uniformly expel fluid from the device reservoir. 
         [0021]    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. 
         [0022]    Another object of the invention is to provide a dispenser that includes precise variable flow rate selection. 
         [0023]    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. 
         [0024]    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. 
         [0025]    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 Another object of the invention is to provide a point of care, self-contained medicament dispenser which is of very simple construction and can be filled at will at time of use. 
         [0026]    Another object of the invention is to provide a fluid dispenser as described in the preceding paragraphs which is easy and inexpensive to manufacture in large quantities. 
     
    
     
       BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS 
         [0027]      FIG. 1  is a generally perspective view of one embodiment of the fluid delivery apparatus of the present invention for dispensing fluids at a uniform rate. 
           [0028]      FIG. 2A  is an enlarged longitudinal cross-sectional rear view of the apparatus shown in  FIG. 1 . 
           [0029]      FIG. 2B  is an enlarged longitudinal cross-sectional front view of the apparatus shown in  FIG. 1 . 
           [0030]      FIG. 3  is a cross-sectional view similar to  FIG. 2 , but showing the apparatus in a fluid fill mode. 
           [0031]      FIG. 3A  is a cross-sectional view taken along lines  3 A- 3 A of  FIG. 3 . 
           [0032]      FIG. 4  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. 
           [0033]      FIG. 5  is a view taken along lines  5 - 5  of  FIG. 4 . 
           [0034]      FIG. 6  is a view taken along lines  6 - 6  of  FIG. 2B . 
           [0035]      FIG. 6A  is a view taken along lines  6 A- 6 A of  FIG. 6 . 
           [0036]      FIG. 7  is a cross-sectional view taken along lines  7 - 7  of  FIG. 2A . 
           [0037]      FIGS. 8A and 8B , when considered together comprise a generally perspective, exploded view of the various internal operating components of the apparatus of the invention. 
           [0038]      FIG. 8C  is a generally perspective exploded view of one form of the indexing means of the invention. 
           [0039]      FIG. 8D  is a fragmentary front view similar to the front view shown in  FIG. 6 , but better showing the configuration of the indexing means of the invention. 
           [0040]      FIG. 8E  is a cross-sectional view taken along lines  8 E- 8 E of  FIG. 8D . 
           [0041]      FIG. 8F  is an enlarged, fragmentary, bottom view of the forward portion of the apparatus shown in  FIG. 3 . 
           [0042]      FIG. 8G  is a cross-sectional view taken along lines  8 G- 8 G of  FIG. 8F . 
           [0043]      FIG. 8H  is a fragmentary cross-sectional view similar to  FIG. 8G  but showing the indexing means in a locked position. 
           [0044]      FIG. 9  is a generally perspective front view of one form of the fluid flow control assembly of the apparatus of the invention. 
           [0045]      FIG. 10  is a generally perspective exploded front view of the fluid flow control assembly shown in  FIG. 9 . 
           [0046]      FIG. 11  is a fragmentary cross-sectional view of one of the flow control channels formed in the flow control member shown in the central portion of  FIG. 10 . 
           [0047]      FIG. 12  is a generally perspective rear view of the fluid flow control assembly of the apparatus of the invention shown in  FIG. 9 . 
           [0048]      FIG. 13  is a generally perspective exploded rear view of the fluid flow control assembly shown in  FIG. 10 . 
           [0049]      FIG. 13A  is a generally perspective view of an alternate form of the flow control member of the invention. 
           [0050]      FIG. 13B  is a generally perspective view of yet another form of the flow control member of the invention. 
           [0051]      FIG. 14  is a front view of the assembly shown in  FIG. 9 . 
           [0052]      FIG. 15  is a cross-sectional view taken along lines  15 - 15  of  FIG. 14 . 
           [0053]      FIG. 16  is a cross-sectional view taken along lines  16 - 16  of  FIG. 15 . 
           [0054]      FIG. 17  is a cross-sectional view taken along lines  17 - 17  of  FIG. 15 . 
           [0055]      FIG. 18  is a view taken along lines  18 - 18  of  FIG. 15 . 
           [0056]      FIG. 19  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. 
           [0057]      FIG. 20  is a generally perspective exploded rear view of the alternate form of the invention shown in  FIG. 19 . 
           [0058]      FIG. 21  is a generally perspective front view of the alternate form of the invention shown in  FIG. 19 . 
           [0059]      FIG. 22  is an enlarged longitudinal cross-sectional view of the manifold and control apparatus shown in  FIG. 19 . 
           [0060]      FIG. 22A  is a generally perspective exploded view of the apparatus shown in  FIG. 22 . 
           [0061]      FIG. 23  is an end view of one of the prefilled medicament shell vials that can be used to fill the fluid reservoir of the apparatus. 
           [0062]      FIG. 24  is a view taken along lines  24 - 24  of  FIG. 23 . 
           [0063]      FIG. 25  is cross-sectional view taken along lines  25 - 25  of  FIG. 22 . 
           [0064]      FIG. 26  is a view taken along lines  26 - 26  of  FIG. 22 . 
           [0065]      FIG. 27  is a view taken along lines  27 - 27  of  FIG. 22 . 
           [0066]      FIG. 28  is a cross-sectional view taken along lines  28 - 28  of  FIG. 22 . 
           [0067]      FIG. 29  is a bottom view of the apparatus shown in  FIG. 19 . 
           [0068]      FIG. 30  is a cross-sectional view taken along lines  30 - 30  of  FIG. 22 . 
           [0069]      FIG. 31  is a fragmentary side elevational view of the forward portion of the alternate form of the apparatus shown in  FIG. 19 . 
           [0070]      FIG. 32  is a generally perspective view of still another embodiment of the fluid delivery apparatus of the present invention for dispensing fluids at a uniform rate. 
           [0071]      FIG. 32A  is a cross-sectional view of the fill vial assembly of the form of the invention shown in  FIG. 32 . 
           [0072]      FIG. 33  is a top plan view of the alternate form of the invention shown in  FIG. 32 . 
           [0073]      FIG. 34  is a side elevational view of the fill vial cover assembly of the alternate form of the invention shown in  FIG. 32 . 
           [0074]      FIG. 35  is a view taken along lines  35 - 35  of  FIG. 34 . 
           [0075]      FIG. 36  is a right-end view of the apparatus shown in  FIG. 37 . 
           [0076]      FIG. 37  is cross-sectional view taken along lines  37 - 37  of  FIG. 36 . 
           [0077]      FIG. 38  is a bottom plan view of the alternate form of the apparatus shown in  FIG. 32 . 
           [0078]      FIG. 39  is a cross-sectional view taken along lines  39 - 39  of  FIG. 37 . 
           [0079]      FIG. 40  is a view taken along lines  40 - 40  of  FIG. 37 . 
           [0080]      FIG. 41  is a cross-sectional view taken along lines  41 - 41  of  FIG. 37 . 
           [0081]      FIG. 42  is a cross-sectional view taken along lines  42 - 42  of  FIG. 37 . 
           [0082]      FIG. 43  is a generally perspective view of yet another embodiment of the fluid delivery apparatus of the present invention for dispensing fluids at a uniform rate. 
           [0083]      FIG. 44  is an enlarged longitudinal cross-sectional view of the embodiment of the invention shown in  FIG. 43 . 
           [0084]      FIG. 45  is a cross-sectional view taken along lines  45 - 45  of  FIG. 44 . 
           [0085]      FIG. 46  is a left-end view of the apparatus shown in  FIG. 44 . 
           [0086]      FIG. 47  is view taken along lines  47 - 47  of  FIG. 44 . 
           [0087]      FIG. 48  is a cross-sectional view taken along lines  48 - 48  of  FIG. 44 . 
           [0088]      FIG. 49  is an enlarged view of one of the fill vial assemblies shown in  FIG. 44 . 
           [0089]      FIG. 49A  is a view taken along lines  49 A- 49 A of  FIG. 49 . 
           [0090]      FIG. 50  is a generally perspective exploded view of the alternate form of the invention shown in  FIG. 43 . 
           [0091]      FIG. 51  is a generally perspective view of still another embodiment of the fluid delivery apparatus of the present invention for dispensing fluids at a uniform rate. 
           [0092]      FIG. 52  is an enlarged longitudinal cross-sectional view of the embodiment of the invention shown in  FIG. 51 . 
           [0093]      FIG. 53  is a cross-sectional view taken along lines  53 - 53  of  FIG. 52 . 
           [0094]      FIG. 54  is a left-end view of the apparatus shown in  FIG. 52 . 
           [0095]      FIG. 55  is a side view of the vial cover assembly of the apparatus of the invention. 
           [0096]      FIG. 56  is a view taken along lines  56 - 56  of  FIG. 55 . 
           [0097]      FIG. 57  is an enlarged, longitudinal, cross-sectional view of one of the fill vial assemblies shown in  FIG. 52 . 
           [0098]      FIG. 58  is a cross-sectional view taken along lines  58 - 58  of  FIG. 57 . 
           [0099]      FIG. 59  is an enlarged, longitudinal, cross-sectional view of the other fill vial assembly of the apparatus of the invention. 
           [0100]      FIG. 60  is a cross-sectional view taken along lines  60 - 60  of  FIG. 59 . 
           [0101]      FIG. 61  is a cross-sectional view of an alternate form of fill vial assembly of the invention. 
           [0102]      FIG. 62  is a cross-sectional view taken along lines  62 - 62  of  FIG. 61 . 
           [0103]      FIG. 63  is a generally perspective exploded view of the embodiment shown in  FIG. 51 . 
           [0104]      FIG. 64  is a generally perspective view of still another embodiment of the fluid delivery apparatus of the present invention for dispensing fluids at a uniform rate. 
           [0105]      FIG. 65  is a top plan view of the embodiment of the invention shown in  FIG. 64 . 
           [0106]      FIG. 66  is a longitudinal cross-sectional view of the embodiment of the invention shown in  FIG. 64 . 
           [0107]      FIG. 67  is a right-end view of the apparatus shown in  FIG. 66 . 
           [0108]      FIG. 68  is a bottom plan view of the apparatus of the invention. 
           [0109]      FIG. 69  is a cross-sectional view taken along lines  69 - 69  of  FIG. 66 . 
           [0110]      FIG. 70  is a generally perspective exploded view of the apparatus of this latest form of the invention. 
           [0111]      FIG. 71  is a generally perspective front view of yet another embodiment of the fluid delivery apparatus of the present invention for dispensing fluids at a uniform rate. 
           [0112]      FIG. 72  is a generally perspective rear view of the embodiment shown in  FIG. 71 . 
           [0113]      FIG. 73  is an enlarged longitudinal cross-sectional view of the apparatus shown in  FIG. 71 . 
           [0114]      FIG. 74  is an enlarged cross-sectional view of the area designated as “74” in  FIG. 73 . 
           [0115]      FIG. 75  is a right end view of the apparatus shown in  FIG. 73 . 
           [0116]      FIG. 76  is an exploded view of the forward section of the apparatus shown in  FIG. 73 . 
           [0117]      FIG. 77  is a cross-sectional view taken along lines  77 - 77  of  FIG. 76 . 
           [0118]      FIG. 78  is a view taken along lines  78 - 78  of  FIG. 76 . 
           [0119]      FIG. 79  is a cross-sectional view taken along lines  79 - 79  of  FIG. 78 . 
           [0120]      FIG. 80  is a view taken along lines  80 - 80  of  FIG. 76 . 
           [0121]      FIG. 81  is a greatly enlarged cross-sectional view of one form of the rate control assembly of the invention. 
           [0122]      FIG. 82  is an exploded, cross-sectional view of the rate control assembly shown in  FIG. 81 . 
           [0123]      FIG. 83  is a generally perspective, exploded front view of the rate control assembly shown in  FIG. 81 . 
           [0124]      FIG. 84  is a generally perspective exploded rear view of the rate control assembly shown in  FIG. 81 . 
           [0125]      FIG. 85  is a cross-sectional view taken along lines  85 - 85  of  FIG. 81 . 
           [0126]      FIG. 86  is a view similar to  FIG. 85 , but showing an alternate form of the fluid flow control member of the rate control assembly of the invention. 
           [0127]      FIG. 86A  is an enlarged cross-sectional view taken along lines  86 A- 86 A of  FIG. 86 . 
           [0128]      FIG. 87  is an exploded view of still another form of the rate control assembly of the invention. 
           [0129]      FIG. 88  is an exploded view of yet another form of the rate control assembly of the invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0130]    Referring to the drawings and particularly to  FIGS. 1 through 8H , one embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral  34 . As best seen in  FIGS. 1 and 2A  and  2 B, the apparatus here comprises a snap-together plastic outer housing  35  having a first, second and third portions  36 ,  38  and  40  respectively. Disposed within outer housing  34  is an inner, expandable housing  42  having a fluid reservoir  44  provided with an inlet  46  ( FIG. 2B ) for permitting fluid flow into the fluid reservoir and an outlet  48  for permitting fluid flow from the fluid reservoir. Expandable housing  42 , which can be constructed from a metal or plastic material, comprises a bellows structure having an expandable and compressible, accordion-like, annular-shaped sidewall  42   a , the configuration of which is best seen in  FIG. 3 . If the internal materials interface of the bellows structure and other fluid channels or surfaces are not sufficiently compatible with the planned beneficial agent to be delivered, either in terms of its biocompatibility or drug up-take characteristics, application of a surface modification process is appropriate. This surface modification methodology which may involve one or more layers, may take one of several forms. One process that is extremely clean, fast and efficient 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 internal drug surface of the bellows. For cases where an inert hydrophobic interface is desired, plasmas using fluorine-containing molecules may be employed. That is, the bellows surface as well as other surfaces that may be contacted by the beneficial agent 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. 
         [0131]    Disposed within second portion  38  of outer housing  34  is the novel stored energy means of the invention for acting upon expandable housing  42  in a manner to controllably collapse the expandable housing so as to cause the fluid contained within fluid reservoir  44  to controllably flow outwardly of the housing. In the present form of the invention, this important stored energy means here comprises a compressively deformable, generally homogeneous member  50  that is carried within the second portion  38  of the outer housing. As used herein, the term “homogeneous” means a member of the same general composition or structure throughout, that is, of the same kind and nature as opposed to a member consisting of different elements. In a manner presently to be described, member  50  which is depicted in  FIG. 2A  as an elastomeric polymeric member, is first compressed by fluid flowing into reservoir  44  and then is controllably expanded to cause fluid flow from the outer housing through the dispensing means of the invention. It is to be understood that the stored energy means can be constructed from a wide variety of solid, semisolid, and cellular materials including open cell, closed cell, syntactic forms with micro spheres, rubbers, foams, sponges, metalized foams, plastics and other thermoplastic elastomers (TPE). Other suitable materials include latex rubber, rubber polyolefins, polyisoprene (natural rubber), butyl rubber, nitrile rubber, polystyrene, polyethylene, polyvinyl chloride polyurethane, vinyls, vinyl-end-blocked polydimethylsiloxanes, other homopolymer, copolymers (random alternating, block, graft, cross-link and star block), silicones and other flouropolymers, mechanical poly-blends, polymer alloys and interpenetrating polymer networks. Suppliers of elastomeric materials suitable for construction of member  50  include “2 and 5 Plastics” of Newark, N.J.; Ludlow Composite Corp. of Fremont, Ohio and Polymer Technologies, Inc. of Newark, Del. Member  50  can also comprise a ductile metalized foam of the character available from various sources, including “Chemetall” of Frankfurt, Germany 
         [0132]    Forming an important aspect of the apparatus of the present invention is fill means carried by the third portion  40  of outer housing  34  for filling the reservoir  44  with the fluid to be dispensed. As best seen in  FIG. 2B , third portion  40  includes a fluid passageway  52  in communication with inlet  46  of fluid reservoir  44 . Proximate its lower end  52   a , fluid passageway  52  communicates with a cavity  54  formed within the third portion of the housing  34 . Disposed within cavity  54  is a pierceable septum  56  that comprises a part of one form of the fill means of the invention. Septum  56  is held in position by a retainer  56   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  44  via passageway  52  or to retrieve fluid from reservoir  44 . Septum  56  can be a slit or a solid septum constructed from an elastomeric material such as silicone rubber. Additionally, a mechanical check valve can function as a septal interface, for drug filling and for residual drug recovery such as valves available from C. R. Bard of Murray Hill, N.J. 
         [0133]    Third portion  40  of housing  34  also includes a first chamber  60  for telescopically receiving a first medicament containing fill vial  62  such as a closed-end glass or plastic shell vial, and a second chamber  64  for telescopically receiving a similarly constructed second medicament containing vial  66 . An elongated support  68  is mounted within said first chamber  60  and a second elongated support  70  is mounted within second chamber  64 . Each of the elongated supports  68  and  70  has an integrally threaded end portion  71  and carries a longitudinally extending, elongated hollow needle or cannula  72 . Each of the hollow needles  72  has a flow passageway  72   a  that communicates with fluid passageway  52 . First chamber  60 , second chamber  64 , elongated support  68 , elongated support  70  and hollow needles  72  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. 
         [0134]    Forming another very important aspect of the apparatus of the present invention is a novel flow control means that is connected to first portion  36  of outer housing  34 . This flow control means functions to precisely control the outwardly rate of fluid flow from reservoir  44  and toward the patient. In the form of the invention shown in  FIGS. 1 through 18  the flow control means comprises a flow control assembly generally designated in the drawings by the numeral  76 . This novel flow control assembly here comprises an ullage defining member  78  having a first portion  78   a  disposed within inner, expandable housing  42  and a second portion  78   b  to which the bellows is bonded. Portion  78   b  extends outwardly from housing  42  in the manner shown in  FIG. 2B . Bellows  42  cooperates with and is slidably movable relative to ullage portion  78   a  in the manner shown in  FIGS. 2B and 3 . For a purpose presently to be described, member  78   b  has a fluid passageway  79  that is in communication with an outlet of the flow control subassembly  80 , the character of which will next be described. Portion  78   a  of the ullage member functions to ensure that substantially all of the medicinal fluid contained within the bellows reservoir will be dispensed from the device. 
         [0135]    Referring to  FIGS. 10 through 13 , it can be seen that flow control subassembly  80 , which comprises a part of flow control assembly  76 , includes an outer casing  82  having a plurality of circumferentially spaced apart fluid outlets  84  (see  FIG. 10 ), a flow control member  86  telescopically receivable within casing  82  and a selector knob  88  that is interconnected with control member  86  in the manner shown in  FIGS. 9 and 12 . O-rings generally designated in the drawings as “O” sealably interconnect the various components (see  FIG. 15 ). As best seen in  FIGS. 10 and 13 , flow control member  86  is uniquely provided with a plurality of elongated flow control channels  90 , each having an inlet  90   a  and an outlet  90   b . The flow channels  90  may be of different sizes, lengths, width and depth and configurations as shown by  FIGS. 13A and 13B  which depict alternate patterned forms of the flow control member, here identified as  86   a  and  86   b . The flow control channels identified in  FIG. 13B  by the numeral  90   b  are formed in individual, spaced-apart capillary segments  91  and define the circuitous flow path depicted in  FIG. 13B . Further, the flow control channels may be rectangular in cross-section as illustrated in  FIG. 11 , 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. As indicated by the designation “C”, when necessary for drug compatibility reasons, the flow channels can be appropriately coated in the manner indicated in  FIG. 11 . Coating “C” can be of various types and the coating can be applied by several techniques including the earlier-described cold plasma processing technique. When the flow control member is properly positioned within outer casing  82 , the inner surface of the outer casing wall sealably cooperates with channels  90  to form a plurality of individual shaped fluid flow passageways of different overall lengths and flow capacities. When the flow control member is positioned within the outer casing in the manner shown in  FIG. 12 , a notch  86   b  formed in member  86  receives a tongue  82   a  provided on casing  82  so as to precisely align the outlets  90   b  of the flow channels  90  with fluid outlets  84  formed in casing  82  (see  FIG. 10 ). 
         [0136]    The flow control channels  90  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. 
         [0137]    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 0.5 mm. or less. 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 the embossing tool is fabricated, the polymer of choice may be injection molded or embossed to yield the desired part with imprinted channels. 
         [0138]    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 or 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 from multiple sources including MicroTEC MbH of Duisburg, Germany. 
         [0139]    A number of materials can be used to fabricate flow control member  86 . 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. 
         [0140]    Selector knob  88 , which comprises a part of the selector means of the invention, is rotatably connected to second portion  78   b  of ullage defining member  78  and, in a manner presently to be described, functions to rotate the assembly made up of outer casing  82  and flow control member  86 . In this way, a selected outlet  84  in casing  82  can be selectively aligned with flow passageway  79  provided in the ullage defining member (see  FIG. 2B ). 
         [0141]    Turning once again to  FIG. 1 , 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  94  that is connected to the first portion  36  of housing  34  in the manner shown in the drawings. The proximal end  95   a  of administration line  95  of the administration set or channel  94  is in communication with fluid passageway  79  in the manner best seen in  FIG. 2B . Disposed between the proximal end  95   a  and the distal end  95   b  of the administration line is a conventional gas vent and particulate filter  96  and clamp  97 . Provided at the distal end  95   b  is a luer connector  98  of conventional construction. 
         [0142]    Turning now to  FIGS. 4 and 5 , the details of construction of a glass or plastic shell vial  62 , which vial is identical in construction to fill vial  66 , is there shown. As indicated in these Figures, each of the fill vials includes a body portion  100 , having a fluid chamber  102  for containing an injectable fluid. Chamber  102  is provided with a first open end  100   a  and second closed end  100   b . First open end  100   a  is sealably closed by closure means here provided in the form of an externally threaded elastomeric plunger  104  which is telescopically movable within the vial from a first location shown in  FIG. 4 , where the plunger is disposed proximate first open end  100   a , to a second device-fill location shown in  FIG. 2A  where the plunger is disposed proximate second closed end  100   b.    
         [0143]    After opening of closure  103 , which forms a part of the third portion  40  of housing  34  ( FIG. 3 ), vials  62  and  66  can be inserted into chambers  60  and  64  respectively. As the fill vials are so introduced and the plungers  104  are threadably interconnected with ends  71  of supports  68  and  70 , the sharp ends of the elongated needles will pierce the central walls  104   a  of the elastomeric plungers. Continuous longitudinal movement of the vials into chambers  60  and  64  will cause the structural supports  68  and  70  to move the elastomeric plungers inwardly of the vial chambers in a direction toward the second closed end  100   b  of the vials. As the plunger is moved inwardly of the vial in the manner shown in the lower portion of  FIG. 3 , wherein only vial  66  is shown being used, the fluid contained within the vial chamber will be expelled therefrom into the passageway  72   a  of hollow elongated needles  72 . As best seen in  FIG. 2B , the fluid will then flow past umbrella type check valves  108  and into passageways  110  formed in third portion  40  of the apparatus housing. Elastomeric umbrella type check valves  108  will function to substantially block reverse fluid flow from fluid passageways  110 . From passageways  110  the fluid will flow into passageway  52 , into stub passageway  52   b  and then into the reservoir portion  44  of the bellows component  42  via inlet  46  which comprises micro-channels formed in ullage  78   a . It is to be understood that the vials  62  and  66  can contain the same or different medicinal fluids or diluents and can be installed into their respective chambers in the manner shown in  FIGS. 2A and 3 . 
         [0144]    As the fluid flows into the reservoir portion of the bellows, the bellows will be expanded from the collapsed configuration shown in  FIG. 2A  into an expanded configuration such as shown in  FIG. 3 . As the bellows member expands it will simultaneously urge a telescopically movable volume indicator member  112  that is carried within second portion of the housing into engagement with the stored energy source, or compressible-expandable member  50  causing it to compress. It is also to be understood that, if desired, the reservoir portion 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  56  which is mounted within third portion  40  of the apparatus housing. Fluid can also be retrieved from the reservoir using a syringe in conjunction with a mechanical septum or, alternatively, septum  56 . 
         [0145]    As the reservoir  44  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  78   b  of the ullage member. This vent means here comprises a gas vent  113  that is bonded to the housing and can be constructed of a suitable hydrophobic porous material such as a porous plastic. Bonded gas vent  113  is held in position within the housing by a retainer ring  113   a  ( FIG. 8B ). This alternate fill means can be used to initially fill the reservoir or alternatively can be used to add an injectable fluid such as an adjuvant fluid. 
         [0146]    Upon opening the fluid delivery path to the administration set  94  in a manner presently be described, the stored energy means, or member  50 , will tend to return to its starting configuration thereby controllably urging fluid flow outwardly of reservoir  44  via passageway  114  and the flow control means of the invention. 
         [0147]    As previously discussed, a number of beneficial agents can be contained within liquid vial containers  62  and  66  and can be controllably dispensed to the patient including, by way of example, medicaments of various types, injectable 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. 
         [0148]    Considering next the important operation of the fluid flow rate control means of the invention, as the fluid contained within the bellows reservoir  44  is urged outwardly thereof by the stored energy means, the fluid will flow into a fluid passageway  114  formed in the first portion  78   a  of ullage member  78 . The fluid will then flow under pressure through a filter means shown here as a filter  116  that is carried in a cavity provided in the flow control member  86  of the flow control subassembly  80 . Filter  116  which functions to filter particulate matter, undissolved drugs, or precipitates from the fluid flowing outwardly from reservoir  44 , is of a character well known to those skilled in the art and can be constructed from various readily available materials such as polysulfone and polypropylene wafers having a desired porosity. After flowing through filter  116 , the fluid will flow, via a stub passageway  118  ( FIG. 15 ) into the distribution means of the invention for distributing fluid from the fluid reservoir to each of the plurality of spiral passageways  90 . This distribution means here comprises several radially outwardly extending flow passageways  120  formed in flow control member  86 . The filtered fluid will fill passageways  120  and then will flow into the plurality of spiral passageways  90  formed in member  86  via outlets  90   b , which communicate with passageways  120  (see  FIG. 10 ). The fluid contained within spiral passageways  90  can flow outwardly of the device housing only when one of the fluid outlets  84  formed in casing  82  is aligned with reservoir outlet  79 . 
         [0149]    Selection of the passageway  90  from which the fluid is to be dispensed is accomplished by rotation of the selector knob  88  which, as best seen in  FIG. 13  includes a reduced diameter portion  88   a  having a slot  88   b  formed therein. As illustrated in  FIG. 13 , slot  88   b  is adapted to receive a spline  86   a  ( FIG. 10 ) formed anteriorly of member  86 . With this construction, rotation of selector member  88  by gripping a transversally extending finger gripping member  89  will impart part rotation to member  86 . As seen in  FIG. 13 , casing  82  is also provided with an inwardly extending spline segment  82   a  that is received within a slot  86   b  formed in the rearward periphery of member  86 . Accordingly, rotation of member  86  will also impart concomitant rotation to casing member  82 . 
         [0150]    As illustrated in  FIGS. 12 and 13 , selector knob  88  is provided with a plurality of circumferentially spaced apart indexing cavities  88   c  that closely receive an indexing finger  124  (see  FIG. 2B ) which forms a part of the indexing means of the invention, which means comprises a locking shaft cover  126  that is connected to third portion  40  of the apparatus housing (see  FIGS. 1 and 2B ). Indexing finger  124  is continuously urged into engagement with a selected one of the indexing cavities  88   c  by a coil spring  128  that also forms a part of the indexing means of the invention. Coil spring  128  ( FIG. 2B ) can be compressed by an inward force exerted on an indexing shaft  130  that is mounted in locking shaft cover  126  and is movable from the extended position shown in  FIG. 2B  to an inward, finger release position wherein spring  128  is compressed and finger  124  is retracted from a selected indexing cavity  88   c . With finger  124  in its retracted position it is apparent that control knob  88  can be freely rotated to a position wherein flow rate indicia  134  (see  FIGS. 9 and 13 ) formed on the periphery of knob  88  ( FIG. 9 ) can be viewed through a viewing window  36   a  formed in the first portion  36  (see  FIG. 1 ) of the apparatus housing. Locking means, here provided in the form of a locking tab  140  (see  FIG. 8C ), is also carried by the locking shaft cover and, when moved from the release position shown in  FIG. 8G  into the locking position shown in  FIG. 8H , prevents inward movements of the indexing shaft  130  against the urging of spring  128  ( FIGS. 6A ,  8 B,  8 D,  8 E and  8 F). A spring biased retainer pin  141  ( FIG. 8E ) functions to retain the selector knob in position within housing  34 . 
         [0151]    When the selector knob is in the desired position and pressure is released on indexing shaft  130 , spring  128  will urge finger  124  of the indexing means of the invention into locking engagement with one of the indexing cavities  88   c  thereby placing a selected one of the spiral shaped flow control channels  90  in communication with the fluid reservoir  44  via passageways  120 ,  118  and  114 . As the fluid flows outwardly of the apparatus due to the urging of the stored energy means  50 , the bellows structure  42  will be collapsed and at the same time member  112  will travel inwardly of housing portion  38 . Member  112 , which forms a part of the volume indicator means of the invention, includes a radially outwardly extending indicating finger  112   a  that is visible through a volume indicator window  143  that is provided in second portion  38  of the apparatus housing and also comprises a part of the volume indicator means of the invention ( FIG. 1 ). Indicia  145 , which are provided on indicator window  143 , function to readily indicate to the caregiver the amount of fluid remaining within fluid reservoir  44 . 
         [0152]    A safety disabling means is shown here as a disabling shaft  151  that is telescopically movable within a passageway  151   a  formed within the housing functions to disable the device and render it unusable. More particularly, shaft  151  has a distal end  151   b  which, upon insertion of the shaft, will block fluid flow through passageway  79 . A retainer  151   c  normally holds shaft  151  in the retracted position (see  FIG. 3A ). 
         [0153]    Turning next to  FIGS. 19 through 31 , an alternate embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral  153 . This alternate form of the apparatus of the invention is similar in many respects to that shown in  FIGS. 1 through 18  and like numerals are used in  FIGS. 19 through 31  to identify like components. As best seen in  FIGS. 19 ,  20  and  21 , the apparatus of this alternate form of the invention comprises an outer housing  154  having first, second and third portions  156 ,  158  and  160  respectively. Disposed within outer housing  154  is an inner, expandable housing  162  that is quite similar in construction and operation to expandable housing  42 . Housing  162  includes a fluid reservoir  164  that is provided with an inlet  166  ( FIG. 22 ) for permitting fluid flow into the fluid reservoir. Expandable housing  162 , like expandable housing  42 , comprises a bellows structure having an expandable and compressible, accordion-like, annular sidewall  162   a  of the character best seen in  FIG. 22 . 
         [0154]    Disposed within second portion  158  of outer housing  154  is the stored energy means of the invention for acting upon inner expandable housing  162  in a manner to cause the fluid contained within fluid reservoir  164  to controllably flow through outlet  185 . In this alternate form of the invention, the important stored energy means is also similar in construction and operation to the earlier described stored energy means and here comprises a compressively deformable, elastomeric member  170  that is carried within the second portion  158  of the outer housing. As before, in operation member  170  is first compressed by fluid flowing into reservoir  164  and then is controllably expanded to cause fluid flow from the fluid reservoir. Stored energy member  170  can be constructed from a wide variety of materials including those materials earlier described herein. 
         [0155]    As in the earlier described embodiment of the invention, the apparatus of this alternate form of the invention comprises fill means carried by the third portion  160  of outer housing  154  for filling the reservoir  164  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 only one fill vial  172  which is identical in construction and operation to the earlier described fill vial  62 . As before, the fill means also includes an alternate fill means that comprises a pierceable septum  56  that is disposed within a cavity  54  formed in the third portion  160  of outer housing  154 . Septum  56  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 reservoir  164  or to recover medicinal fluid therefrom via a passageway  171  formed in third portion  160 . 
         [0156]    Third portion  160  of housing  154  includes a chamber  174  for telescopically receiving the medicament containing fill vial  172 . An elongated support  178 , which is mounted within chamber  174 , is provided with an internally threaded end portion  175  and a longitudinally extending, elongated hollow needle  180  which has a flow passageway  180   a  that communicates with a fluid passageway  171  via an umbrella type check valve  182  and a stub passageway  171   a.    
         [0157]    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. 1 through 18 . This flow control means is connected to first portion  156  of outer housing  154  and comprises an ullage defining member  184  having a first portion  184   a  disposed within inner, expandable housing  162  and a second portion  184   b  having a fluid passageway  185  that is in communication with fluid reservoir  164   
         [0158]    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  80  and is of the configuration shown in  FIGS. 9 ,  10 ,  12  and  13  of the drawings. Accordingly, 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  80 . 
         [0159]    Turning once again to  FIG. 19 , 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  94  and is connected to the first portion  156  of housing  154 . 
         [0160]    Turning now to  FIGS. 23 and 24 , it is to be noted that glass or plastic shell vial  172  is identical in construction to fill vial  66  and includes a fluid chamber  102  for containing an injectable fluid. Chamber  102  is provided with a first open end  100   a  and second closed end  100   b . First open end  100   a  is sealably closed by closure means here provided in the form of an externally threaded elastomeric plunger  104  which is telescopically movable within the vial from a first location shown in  FIG. 24 , where the plunger is disposed proximate first open end  100   a , to a second location where the plunger is disposed proximate second, closed end  100   b.    
         [0161]    After opening of cover  160   a  ( FIG. 22 ), vial  172  can be inserted into chamber  174 . As the fill vial is so introduced and the plunger  104  is threadably interconnected with end  175  of the elongated support, the sharp end of elongated needle  180  will pierce the central wall  104   a  of the elastomeric plunger. Continuous movement of the vial into chamber  174  will cause the structural support  178  to move the elastomeric plunger inwardly of the vial chamber in a direction toward the second closed end  100   b  of the vial. As the plunger is moved inwardly of the vial, the fluid contained within the vial chamber will be expelled therefrom into the hollow elongated needle  180 . As best seen in  FIG. 22 , the fluid will then flow past umbrella type check valve  182  and into passageway  171  formed in third portion  160  of the apparatus housing. 
         [0162]    As the fluid flows into the bellows reservoir, the bellows will be expanded from the collapsed configuration shown in  FIG. 22  into an expanded configuration. As the bellows member expands it will urge a telescopically movable volume indicator member  112  that is carried within second portion of the housing and in engagement with the stored energy source, or compressible-expandable member  170  causing it to compress. 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  56  which is mounted within third portion  160  of the apparatus housing. As the reservoir  164  fills with fluid either from the fill vial  172  or from the filling syringe, any gases trapped within the reservoir will be vented to atmosphere via vent means “V” which comprises the earlier described gas vent  113 . 
         [0163]    Upon opening the fluid delivery path to the administration set  94  in a manner presently to be described, the stored energy means, or member  170 , will tend to return to its less compressed starting configuration thereby controllably urging fluid flow outwardly of reservoir  164  via passageway  185  and the flow control means of the invention. As the fluid contained within the bellows reservoir  164  is urged outwardly thereof by the stored energy means, the fluid will flow into a fluid passageway  185  formed in the first portion  184   a  of ullage member  184 . The fluid will then flow under pressure through a filter means shown here as a filter  116  that is identical to that previously described. After flowing through filter  116 , the fluid will flow, via a stub passageway  185   a  ( FIG. 22 ) into the several radially outwardly extending flow passageways  120  formed in flow control member  86 . The filtered fluid will fill passageways  120  and then will flow into the plurality of spiral passageways  90  formed in member  86  via outlets  90   b , which communicate with passageways  120  (see  FIG. 10 ). The fluid contained within spiral passageways  90  can flow outwardly of the device only when one of the fluid outlets  84  formed in casing  82  is aligned with a passageway  186  formed in the ullage member. 
         [0164]    Selection of the passageway  90  from which the fluid is to be dispensed is accomplished by rotation of the selector knob  88  in the manner previously described in connection with the embodiment shown in  FIGS. 1 through 18 . The construction and operation of the selector knob is identical to that previously described and will not be re-described at this time. 
         [0165]    As illustrated in  FIGS. 22 and 28 , as before, the distal portion of selector knob  88  is provided with a plurality of circumferentially spaced apart indexing cavities  88   c  that closely receive an indexing finger  190  which forms a part of the indexing means of this latest form of the invention which is carried within third portion  160  of the apparatus housing. Indexing finger  190  is continuously urged into engagement with a selected one of the indexing cavities  88   c  by a coil spring  192  that also forms a part of the indexing means of the invention. Coil spring  192  can be compressed by an inward force exerted on an indexing shaft  194  that is received within front retaining plate  196  and is movable from the extended position shown in  FIG. 22  to an inward, finger release position wherein spring  192  is compressed and finger  190  is retracted from a selected indexing cavity  88   c . With finger  190  in its retracted position it is apparent that control knob  88  can be freely rotated to a position wherein flow rate indicia  134  formed on the periphery of knob  88  can be viewed through a viewing window  136   a  formed in the housing. Button  197  disables (stops the flow) to the dispenser line. 
         [0166]    When the selector knob  88  is in the desired position and pressure is released on indexing shaft  194 , finger  190  of the indexing means of the invention will move into locking engagement with one of the indexing cavities  88   c  thereby placing a selected one of the spiral shaped flow control channels  90  in communication with outlet  186  of the fluid reservoir  164 . As the fluid flows outwardly of the apparatus due to the urging of the stored energy means or elastomeric member  170 , the bellows structure  162  will be collapsed and at the same time member  112  will travel inwardly of housing portion  158  and will provide an indication of the volume of fluid remaining in the fluid reservoir in the same manner as earlier described. 
         [0167]    The apparatus of this latest form of the invention also includes novel safety disabling means for disabling the apparatus. As best seen in  FIGS. 19 and 30 , the disabling means here comprises a disable shaft  197  that is telescopically movable within a passageway  198   a  formed in a housing  198  that forms a part of portion  156  of the outer housing of the apparatus. Shaft  197  includes a distal end  197   a , which, upon insertion of shaft  197  inwardly of passageway  198   a , will block fluid flow through passageway  186  and outwardly into the fluid dispensing means. A retainer  199  normally holds shaft  197  is the retracted position and an elastomeric O-ring  200  carried by shaft  197  prevents fluid leakage past the shaft. 
         [0168]    Referring now to  FIGS. 32 through 42 , still another embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral  202 . This alternate form of the apparatus of the invention is similar in many respects to that shown in  FIGS. 19 through 31  and like numerals are used in  FIGS. 32 through 42  to identify like components. The primary difference between this latest form of the invention and the invention shown in  FIGS. 19 through 31  resides in the fact that the fill vial used to fill the fluid reservoir is of different construction. As best seen in  FIGS. 32 through 36 , the apparatus of this alternate form of the invention comprises an outer housing  202  having mechanically engaged or suitably bonded together first, second and third portions  206 ,  208  and  210  respectively. Disposed within outer housing  206  is an inner, expandable housing  162  that is of identical construction and operation to the expandable housing of the last described embodiment of the invention. Housing  162  includes a fluid reservoir  164  that is provided with an inlet  166  ( FIG. 37 ) for permitting fluid flow into the fluid reservoir. As before, expandable housing  162  comprises a bellows structure having an expandable and compressible, accordion like sidewall  162   a  of the character best seen in  FIG. 37 . 
         [0169]    Disposed within second portion  208  of outer housing  202  is the stored energy means of the invention for acting upon inner expandable housing  162  in a manner to cause the fluid contained within fluid reservoir  164  to controllably flow through outlet  185 . In this alternate form of the invention, the important stored energy means is identical in construction and operation to that earlier described in stored energy means and here comprises a compressively deformable, elastomeric member  170  that is carried within the second portion  208  of the outer housing. As before, in operation member  170  is first compressed by fluid flowing into reservoir  164  and then is controllably expanded to cause fluid flow from the fluid reservoir. 
         [0170]    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  210  of outer housing  202  for filling the reservoir  164  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 single cartridge fill vial  212  which is of a slightly different construction and operation from closed-end shell fill vial  172  (see  FIG. 32A ). As before, the fill means also includes an alternate fill and drug recovery means that comprises a pierceable septum  56  that is disposed within a cavity  54  formed in the third portion  210  of outer housing  202 . Septum  56  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 reservoir  164  via a passageway  171  formed in third portion  210 . 
         [0171]    As best seen in  FIG. 37 , third portion  210  of housing  202  includes a chamber  214  for telescopically receiving the medicament containing fill cartridge vial  212 . As shown in  FIG. 34 , an elongated support  218  is mounted within a hollow vial cover  220  that removably covers the fill vial in the manner shown in  FIG. 37 . The purpose of elongated support  218  will presently be described. Fill vial cartridge  212 , which is of the generally conventional construction shown in  FIG. 32A , comprises a hollow glass or plastic body portion  219  having an inner surface  216  that defines a fluid chamber  219   a . The fill cartridge vial has an open first end  214   a  and a second end  214   b  that is closed by a pierceable, elastomeric septum  221  secured in place by a conventional crimp closure means (see  FIG. 32A ). Mounted proximate the inboard end of chamber  214  of housing  202  is a hollow needle  215  ( FIG. 37 ) which is adapted to pierce septum  221  when the fill vial is inserted into chamber  214  in a manner next to be described. 
         [0172]    Disposed within fluid reservoir  219   a  is a plunger  224  that is moved by support  218  of vial cover  220  from a first position proximate end  214   a  of vial  212  to a second position shown in  FIG. 37 . More particularly, as the vial cover  220  is mated with the apparatus housing, the inboard  218   a  of elongated support  218  engages plunger  224  urging the plunger inwardly of fluid chamber  219   a  (see  FIGS. 34 and 32A ). As the plunger moves inwardly of the fluid reservoir, the fluid contained in the reservoir will be forced through hollow needle  215 , passed an umbrella check valve  226  mounted within third portion  210 , into a stub passageway  228 , into passageway  171  and finally into fluid reservoir  164 . As the fluid flows into reservoir  164  it will compress the stored energy means in the manner previously described. 
         [0173]    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. 18 through 31 . This flow control means is connected to first portion  206  of outer housing  202  and comprises an ullage defining member  184  having a first portion  184   a  disposed within inner, expandable housing  162  and a second portion  184   b  having a fluid passageway  186  that is in communication with the outlet of the fluid. reservoir  164   
         [0174]    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  80  and is of the configuration shown in  FIGS. 9 ,  10 ,  12  and  13  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  80 . 
         [0175]    Turning once again to  FIG. 32 , 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  94  and is connected to the first portion  206  of housing  202 . 
         [0176]    Upon opening the fluid delivery path to the administration set  94  in a manner presently to be described, the stored energy means, or member  170 , will tend to return to its less compressed starting configuration thereby controllably urging fluid flow outwardly of reservoir  164  via the flow control means of the invention. As the fluid contained within the bellows reservoir  164  is urged outwardly thereof by the stored energy means, the fluid will flow into a fluid passageway  185  formed in the first portion  184   a  of ullage member  184 . The fluid will then flow under pressure through a filter means shown here as a filter  116  that is identical to that previously described. After flowing through filter  116 , the fluid will flow, via a stub passageway  185   a  ( FIG. 37 ) into the several radially outwardly extending flow passageways  120  formed in flow control member  86 . The filtered fluid will fill passageways  120  and then will flow into the plurality of spiral passageways  90  formed in member  86  via outlets  90   b , which communicate with passageways  120  (see  FIG. 10 ). The fluid contained within spiral passageways  90  can flow outwardly of the device only when one of the fluid outlets  84  formed in casing  82  is aligned with passageway  186  ( FIG. 37 ). 
         [0177]    Selection of the passageway  90  from which the fluid is to be dispensed is accomplished by rotation of the selector knob  88  in the manner previously described in connection with the embodiment shown in  FIGS. 19 through 31 . 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 re-described at this time. 
         [0178]    As in the earlier described embodiments of the invention, as the fluid flows outwardly of the apparatus due to the urging of the stored energy means or elastomeric member  170 , the bellows structure  162  will be collapsed and at the same time member  212  will travel inwardly of housing portion  208  and will provide an indication of the volume of fluid remaining in the fluid reservoir in the same manner as earlier described. 
         [0179]    This latest embodiment also includes disabling means, which, as shown in  FIG. 42 , is substantially identical in construction and operation to that previously described. 
         [0180]    Referring now to  FIGS. 43 through 50 , yet another embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral  230 . This alternate form of the apparatus of the invention is similar in many respects to that shown in  FIGS. 32 through 34  and like numerals are used in  FIGS. 43 through 50  to identify like components. The primary difference between this latest form of the invention and the invention shown in  FIGS. 32 through 42  resides in the fact that two fill vials 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  232  having a first, second and third portions  234 ,  236 , and  238  respectively. Disposed within outer housing  232  is an inner, expandable housing  162  that is of identical construction and operation to the expandable housing of the embodiment of the invention shown in  FIGS. 32 through 42 . As in the earlier described embodiment, housing  162  includes a fluid reservoir  164  that is provided with an inlet  166  ( FIG. 44 ) for permitting fluid flow into the fluid reservoir. As shown in  FIG. 44 , expandable housing  162  comprises a bellows structure having an expandable and compressible, accordion-like side wall  162   a.    
         [0181]    Disposed within second portion  236  of outer housing  232  is the stored energy means of the invention for acting upon inner expandable housing  162  in a manner to cause the fluid contained within fluid reservoir  164  to controllably flow through outlet  186 . 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, elastomeric member  170  that is carried within the second portion  236  of the outer housing. As before, in operation member  170  is first compressed by fluid flowing into reservoir  164  and then is controllably expanded to cause fluid flow from the fluid reservoir. 
         [0182]    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  238  of outer housing  232  for filling the reservoir  164  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 identical fill vials or cartridges  212  which are of the same construction and operation as the earlier described fill vial  212 . As in the previously described embodiments, the fill means also includes an alternate fill means that comprises a pierceable septum  56  that is disposed within a cavity  54  formed in the third portion  238  of outer housing  232 . Septum  56  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 reservoir  164  via a passageway  241  formed in third portion  238 . 
         [0183]    As best seen in  FIGS. 44 and 50 , third portion  238  of housing  232  includes a pair of spaced-apart chambers  242  for telescopically receiving the medicament containing fill vials  212 . As shown in  FIGS. 43 ,  44 , and  50 , a pair of elongated supports  244  are mounted within a hollow vial cover  246  that forms a part of the third portion  238  of the housing and removably covers the fill vials in the manner shown in  FIG. 44 . Each of the fill vial cartridges  212  has a generally conventional construction, shown in  FIGS. 49 and 49A , and each comprises a hollow glass or plastic body portion  219  that defines a fluid chamber  220 . Each fill vial has an open first end  214   a  and a second end that is closed by a pierceable, elastomeric septum  221 . Mounted proximate the inboard end of each chamber of the housing is a hollow needle  215  which is adapted to pierce septum  221  when the fill vials are inserted into chambers  242  in a manner next to be described. 
         [0184]    Disposed within each fluid reservoir  220  is a plunger  224  that is moved by a support  244  of vial cover  246  from a first position proximate end  214   a  of the vial to a second position. More particularly, as the vial cover  246  is slidably mated with the apparatus housing, the inboard of each of the elongated supports engages a plunger  224  urging the plunger inwardly of fluid chamber  220 . As each of the plungers move inwardly of their respective fluid reservoirs, the fluid contained in the reservoir will be forced through hollow needle  215 , passed an umbrella check valve  226  mounted within third housing portion  238 , into a stub passageway  248 , into passageway  241  and finally into fluid reservoir  164  via 166. As the fluid flows into reservoir  164 , it will compress the stored energy means in the manner previously described. 
         [0185]    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. 32 through 42 . This flow control means is connected to first portion  234  of outer housing  232  and comprises an ullage defining member  184  having a first portion  184   a  disposed within inner, expandable housing  162  and a second portion  184   b  having a fluid passageway  186  that is in communication with the outlet of the fluid reservoir  164 . 
         [0186]    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  80  and is of the configuration shown in  FIGS. 9 ,  10 ,  12  and  13  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  80 . 
         [0187]    Turning once again to  FIG. 43 , 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  94  and is connected to the first portion  234  of housing  232 . 
         [0188]    Upon opening the fluid delivery path to the administration set  94 , the stored energy means, or member  170 , will tend to return to its less compressed starting configuration thereby controllably urging fluid flow outwardly of reservoir  164  via the flow control means of the invention. As the fluid contained within the bellows reservoir  164  is urged outwardly thereof by the stored energy means, the fluid will flow into a fluid passageway  185  formed in the first portion  184   a  of ullage member  184 . The fluid will then flow under pressure through a filter means shown here as a filter  116  that is identical to that previously described. After flowing through filter  116 , the fluid will flow, via a stub passageway  185   a  ( FIG. 44 ) in the several radially outwardly extending flow passageways  120  formed in flow control member  86 . The filtered fluid will fill passageways  120  and then will flow into the plurality of spiral passageways  90  formed in member  86  via outlets  90   b , which communicate with passageways  120  (see  FIG. 10 ). The fluid contained within spiral passageways  90  can flow outwardly of the device only when one of the fluid outlets  84  formed in casing  82  is aligned with passageway  186  ( FIG. 44 ). 
         [0189]    Selection of the passageway  90  from which the fluid is to be dispensed is accomplished by rotation of the selector knob  88  in the manner previously described in connection with the embodiment shown in  FIGS. 19 through 31 . 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 re-described at this time. 
         [0190]    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 elastomeric member  170 , the bellows structure  162  will be collapsed and at the same time member  112  will travel inwardly of housing portion  236  and will provide an indication of the volume of fluid remaining in the fluid reservoir in the same manner as earlier described. 
         [0191]    This latest embodiment also includes a safety defeat disabling means, which is substantially identical in construction and operation to that previously described. 
         [0192]    Turning now to  FIGS. 51 through 63 , another form of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral  250 . This alternate form of the apparatus of the invention is similar in many respects to that shown in  FIGS. 43 through 50  and like numerals are used in  FIGS. 51 through 63  to identify like components. The primary difference between this latest form of the invention and the invention shown in  FIGS. 43 through 50  resides in the fact that one of the two cartridge fill vials used to fill the fluid reservoir of the apparatus is of a different construction. More particularly, one of the fill vials is specially designed to enable the reconstitution and intermixing of a lypholized drug with a suitable diluent prior to the delivery of the mixture to the fluid reservoir of the device. 
         [0193]    As in the earlier described embodiments, the apparatus of this latest form of the invention comprises an outer housing  252  having first, second and third portions  254 ,  256  and  258  respectively. Disposed within outer housing  252  is an inner, expandable housing  162  that is of identical construction and operation to the expandable housing of the embodiment of the invention shown in  FIGS. 32 through 42 . As in the earlier described embodiment, housing  162  includes a fluid reservoir  164  that is provided with an inlet  166   a  ( FIG. 52 ) for permitting fluid flow into the fluid reservoir. As shown in  FIG. 52 , expandable housing  162  comprises a bellows structure having an expandable and compressible, accordion like sidewall  162   a.    
         [0194]    Disposed within second portion  256  of outer housing  252  is the stored energy means of the invention for acting upon inner expandable housing  162  in a manner to cause the fluid contained within fluid reservoir  164  to controllably flow through outlet  186 . 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, elastomeric member  170  that is carried within the second portion  256  of the outer housing. As before, in operation, member  170  is further compressed by fluid flowing into reservoir  164  and then is controllably expanded to cause fluid flow from the fluid reservoir. 
         [0195]    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  258  of outer housing  252  for filling the reservoir  164  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  212 , is of identical construction and operation to the earlier described fill vial  212 . The second fill vial or cartridge designated by the numeral  262  comprises a container of special design that uniquely contains a lyophilized drug  264  that is separated from a reconstituting fluid  266  by a barrier stopper  268  ( FIG. 57 ). Lyophilized drug  264  can, by way of example, comprise anti-infectives, oncolytics, cardiac drugs or various other types of beneficial agents. Cartridge  262  is telescopically receivable within a vial housing  270  that is of the configuration shown in  FIGS. 52 ,  55  and  56 . As before, vial housing  270  includes a pair of spaced apart pusher members  272  and  274  which, upon mating of the vial housing within the apparatus housing, engage plungers  224  ( FIG. 59) and 276  ( FIG. 57 ) respectively to push them forwardly of their respective container reservoirs. 
         [0196]    Considering in more detail the reconstitution cartridge assembly  262 , as best seen in  FIG. 57 , this cartridge assembly includes a vial  280  that is sealed at one end by a plunger  276  and at the other end by a pierceable septum  282  ( FIGS. 54   57 , and  61 ). Formed intermediate the ends of vial  280  is a raised outer wall portion  280   a  which permits fluid  266  to bypass barrier stopper  268  as the elastomeric barrier stopper is urged inwardly of the container by pressure exerted thereon by the fluid  266 . Fluid  266  exerts pressure on barrier member  268  as a result of pusher member  274  exerting inward pressure on plunger  276 , which pressure is, in turn, caused by the inward movement of plunger  276  as vial housing  262  is mated with the apparatus housing  270  ( FIG. 52 ). 
         [0197]    A continued inward pressure exerted on elastomeric plunger  276  will cause the reconstitution agent  266  to flow past barrier stopper member  268  via wall portion  280   a  or the bypass chamber, so as to reconstitute lyophilized drug  264 . Further pressure exerted on plunger  276  will cause the reconstituted drug formed by the fluid  266  which has been intermixed with drug  264  to flow through a hollow cannula  215 , past check valve  284 , into a stub passageway  286  then into a passageway  290  then into microgrooves  166   a  formed in ullage  184   a  and finally into reservoir  164  ( FIG. 52 ). 
         [0198]    As previously mentioned, plunger  224  is disposed within vial  212  and is moved by a support  272  of vial cover  270  as the vial cover is slidably mated with the apparatus housing. As plunger  224  is moved inwardly of fluid reservoir  219 , the diluent contained in the reservoir will be forced through hollow needle  215 , passed an umbrella check valve  226  mounted within third housing portion  258 , into a stub passageway  248 , into passageway  290 , into micro-channels  166   a  and finally into fluid reservoir  164 . As the fluid flows into reservoir  164 , it will compress the stored energy means in the manner previously described. 
         [0199]    As in the earlier described embodiments, the fill means also includes an alternate fill and recovery means that comprises a pierceable septum  56  that is disposed within a cavity  54  formed in the third portion  258  of outer housing  252 . Septum  56  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 reservoir  164  via a passageway  290  formed in third portion  258 . 
         [0200]    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. 32 through 42 . This flow control means is connected to first portion  254  of outer housing  252  and comprises an ullage defining member  184  having a first portion  184   a  disposed within inner, expandable housing  162  and a second portion  184   b  having a fluid passageway  186  that is in communication with outlet  168  of the fluid reservoir  164   
         [0201]    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  80  and is of the configuration shown in  FIGS. 9 ,  10 ,  12  and  13  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  80 . 
         [0202]    Turning once again to  FIG. 51 , 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  94  and is connected to the first portion  254  of housing  252 . 
         [0203]    Upon opening the fluid delivery path to the administration set  94  in a manner presently to be described, the stored energy means, or member  170 , will tend to return to its less compressed starting configuration thereby controllably urging fluid flow outwardly of reservoir  164  via the flow control means of the invention. As the fluid contained within the bellows reservoir  164  is urged outwardly thereof by the stored energy means, the fluid will flow into a fluid passageway  185  formed in the first portion  184   a  of ullage member  184 . The fluid will then flow under pressure through a filter means shown here as a filter  116  that is identical to that previously described. After flowing through filter  116 , the fluid will flow, via a stub passageway  185   a  ( FIG. 52 ) into the several radially outwardly extending flow passageways  120  formed in flow control member  86 . The filtered fluid will fill passageways  120  and then will flow into the plurality of spiral passageways  90  formed in member  86  via outlets  90   b , which communicate with passageways  120  (see  FIG. 10 ). The fluid contained within spiral passageways  90  can flow outwardly of the device only when one of the fluid outlets  84  formed in casing  82  is aligned with passageway  186  ( FIG. 52 ). 
         [0204]    Selection of the passageway  90  from which the fluid is to be dispensed is accomplished by rotation of the selector knob  88  in the manner previously described in connection with the embodiment shown in  FIGS. 19 through 31 . 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 re-described at this time. 
         [0205]    As in the earlier described embodiments of the invention, as the fluid flows outwardly of the apparatus due to the urging of the stored energy means or elastomeric member  170 , the bellows structure  162  will be collapsed and at the same time member  112  will travel inwardly of housing portion  256  and will provide an indication of the volume of fluid remaining in the fluid reservoir in the same manner as earlier described. 
         [0206]    This latest embodiment also includes safety defeat disabling means, which, as shown in  FIG. 43 , is substantially identical in construction and operation to that previously described. 
         [0207]    Considering next the alternate form of fill cartridge assembly  292 , shown in  FIGS. 61 and 62 , this fill cartridge is similar in some respects to fill cartridge  262  and includes a vial  294  that is sealed at one end by a plunger  295  and at the other end by a pierceable septum  282 . Formed intermediate the ends of vial  294  is a plurality of spaced-apart, angularly inclined fluid flow passageways  296  which permit fluid  266  to bypass a member or barrier stopper  297  as the barrier stopper is urged inwardly of the container by pressure exerted thereon by fluid  266 . Fluid  266  exerts pressure on barrier member  297  as a result of pusher member  274  of the vial housing  270  exerting inward pressure on plunger  295 , which pressure is, in turn, caused by the inward movement of plunger  295  as vial housing  270  is mated with the housing  252 . 
         [0208]    A continued inward pressure exerted on elastomeric plunger  295  will cause fluid  266  to flow past elastomeric barrier member  297  via flow passageway  296  so as to reconstitute lyophilized drug  264  ( FIG. 61 ). Further pressure exerted on plunger  295  will cause the reconstituted drug formed by the fluid  266  which has been intermixed with drug  264  to flow through a hollow cannula  283  past check valve  284 , into a stub passageway  286 , then into a passageway  290  into the micro-channels  166   a  and, finally, into reservoir  164  ( FIG. 52 ). 
         [0209]    Referring now to  FIGS. 64 through 70 , yet another embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral  302 . This alternate form of the apparatus of the invention is somewhat similar to that shown in the previous Figure drawings and like numerals are used in  FIG. 64 through 70  to identify like components. The primary difference between this latest form of the invention and the invention shown in earlier Figure drawings resides in the fact that the only fill means comprises a septum  304  that is disposed within a cavity  306  in the device housing  308 . Septum  304  is pierceable by the needle of a syringe which contains the medicinal fluid to be dispensed and used to fill the fluid reservoir of the device ( FIG. 66 ). 
         [0210]    As best seen in  FIGS. 64 and 68 , the outer housing  308  comprises first and second portions  310  and  312  respectively. Disposed within outer housing  308  is an inner, expandable housing  162  that is of identical construction and operation to the expandable housing of the earlier described embodiments of the invention. Housing  162  includes a fluid reservoir  164  that is provided with an inlet  314  ( FIG. 66 ) for permitting fluid flow into the fluid reservoir. As before, expandable housing  162  comprises a bellows structure having an expandable and compressible, accordion like sidewall  162   a  of the character best seen in  FIG. 66 . 
         [0211]    Disposed within second portion  312  of outer housing  308  is the stored energy means of the invention for acting upon inner expandable housing  162  in a manner to cause the fluid contained within fluid reservoir  164  to controllably flow through an outlet, the character of which will presently be described. Any gases contained within the expandable housing will be substantially vented to atmosphere through a vent “V” via a passageway  316  and a filter  317 . 
         [0212]    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, elastomeric member  170  that is carried within the second portion  312  of the outer housing. As before, in operation, member  170  is first compressed by fluid flowing into reservoir  164  and then is controllably expanded to cause fluid flow from the fluid reservoir. 
         [0213]    As previously mentioned, in the last described embodiment of the invention, the fill means which is carried by the second portion  312  of outer housing  308  for filling the reservoir  164  with the fluid to be dispensed comprises the septum  304 . Septum  304  is pierceable by the needle of the syringe which contains the medicinal fluid that can be used to fill or partially fill reservoir  164  via passageway  314  formed in second portion  312  of the housing. 
         [0214]    Turning once again to  FIG. 64 , 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  94  and is connected to the ullage defining means of the invention that comprises a part of the housing  308 . This ullage means is provided in the form of an ullage defining member  315  that includes a first portion  315   a  that is disposed within inner expandable housing  162  and a second portion  315   b  having a passageway  316  that is in communication with fluid reservoir  164 . 
         [0215]    Upon opening the fluid delivery path to the administration set  94 , the stored energy means, or member  170 , will tend to return to its uncompressed starting configuration thereby controllably urging fluid flow outwardly of reservoir  164 . As the fluid contained within the bellows reservoir  164  is urged outwardly thereof by the stored energy means, the fluid will flow under pressure through a filter means shown here as filter  116  that is identical to that previously described. After flowing through filter  116 , the fluid will flow, via a stub passageway  318  ( FIG. 66 ) and into a fluid passageway  320 , which comprises a fine bore capillary line portion of the administration set  94 . The capillary line portion can be of various diameters and lengths to thereby enable precise fluid flow rate control. 
         [0216]    As in the earlier described embodiments of the invention, as the fluid flows outwardly of the apparatus due to the urging of the stored energy means or elastomeric member  170 , the bellows structure  162  will be collapsed and at the same time a member  112  will travel inwardly of housing portion and will provide an indication of the volume of fluid remaining in the load reservoir in the same manner as earlier described. 
         [0217]    This latest embodiment also uniquely includes fastening means for releasably fastening the device to the clothing of the patient, such as a shirt pocket or a belt. This fastening means is here provided in the form of a spring clip  322  that is affixed to one side of the housing  308 . 
         [0218]    Referring next to  FIGS. 71 through 85 , yet another embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral  442 . As best seen in  FIGS. 71 and 72 , the apparatus here comprises an outer housing  444  having first and second portions  446  and  448  respectively. Disposed within outer housing  444  is an inner, expandable housing  450  having a fluid reservoir  452  provided with an inlet  454  ( FIG. 73 ) for permitting fluid flow into the fluid reservoir and an outlet  456  for permitting fluid flow from the fluid reservoir. Expandable housing  450 , which can be constructed from a metal or plastic material, comprises a bellows structure having an expandable and compressible, accordion-like, annular-shaped sidewall  450   a , the configuration of which is best seen in  FIGS. 73 and 74 . As best seen in  FIG. 74 , the inner wall of the bellows is provided, in the manner previously described herein, with one or more layers of a protective coating  458  that is compatible with the fluids contained within reservoir  452 . 
         [0219]    Disposed within second portion  448  of outer housing  444  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 fluid reservoir  452  to controllably flow outwardly of the housing. In the present form of the invention, this important stored energy means comprises a compressively deformable, elastomeric member  460  that is carried within the second portion  448  of the outer housing. In a manner presently to be described, member  460  is first compressed by fluid flowing into reservoir  452  and then is controllably expanded to cause fluid flow from the outer housing through the dispensing means of the invention. Stored energy member  460  can be constructed from a wide variety of materials including metals and plastics. By way of example, stored energy member  460  can be constructed from a wide variety of foam-like, solid and cellular materials including rubbers, molded or extruded plastics and other thermoplastic elastomers (TPE) and thermoplastic urethane (TPU) and polyethylene. By way of example, suitable materials include latex rubber, rubber polyolefins, polyisoprene (natural rubber), butyl rubber, nitrile rubber, polyurethane, vinyls, vinyl-end-blocked polydimethylsiloxanes, other homopolymer, copolymers (random alternating, block, graft, cross-link and star block), silicones and other flouropolymers, mechanical poly-blends, polymer alloys and other thermoplastic elastomers (TPE) and thermoplastic urethane (TPU) and polyethylene. 
         [0220]    Forming an important aspect of the apparatus of the present invention is fill means carried by outer housing  444  for filling the reservoir  452  with the fluid to be dispensed. As best seen in  FIG. 73 , first portion  446  includes a fluid passageway  462  in communication with inlet  454  of fluid reservoir  452 . Proximate its lower end  462   a , fluid passageway  462  communicates with a cavity  464  formed within portion  446  of the housing  444 . Disposed within cavity  464  is a pierceable septum  466  that comprises a part of one form of the fill means of the invention. Septum  466  is held in position by a retainer  466   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  452  via passageway  462 . 
         [0221]    Forming another very important aspect of the apparatus of the present invention is a novel flow control means that is disposed interiorly of outer housing  444 . This flow control means functions to precisely control the outwardly rate of fluid flow from reservoir  452  and toward the patient. In the form of the invention shown in  FIGS. 71 through 88  the flow control means comprises a flow control assembly generally designated in the drawings by the numeral  470 . As best seen in  FIGS. 81 and 82 , this novel flow control assembly here comprises an inlet manifold  472  having an inlet port  474  that is in communication with the outlet  456  of the fluid reservoir  452  and an outlet manifold  476  that is interconnected with intake manifold  472  by means of a separator plate  478 . As indicated in  FIGS. 81 and 82 , outlet manifold  476  as an outlet port  479  that is in communication with the outlet of the apparatus and is provided with an elongated micro-channel  480  that is coated with a coating C- 1  ( FIG. 86A ) and is in communication both with inlet port  474  and with the outlet port  479  of the outlet manifold. Disposed intermediate inlet manifold  472  and a generally circular shaped separator plate  478  is filter means, here provided as a filter member  482  that functions to filter fluid flowing toward outlet port  479  of the outlet manifold. Generally disk shaped filter member  482  can be formed from various porous materials, including porous metals, plastics and porous ceramics. 
         [0222]    As best seen in  FIG. 82 , separator plate  478  is provided with standoff ribs  484  for supporting filter member  482  in the manner shown in  FIG. 81 . The assemblage made up of inlet manifold  472 , outlet manifold  476 , separator plate  478  and filter  482  is preferably encapsulated within an outer metal or plastic casing  486  (see  FIG. 81 ). 
         [0223]    As indicated in  FIG. 81 , the flow rate control means, or assemblage  470 , has an axial centerline “C” with which the inlet port  474  of the inlet manifold  472  is coaxial aligned. However, the outlet port  479  of the outlet manifold is radially spaced from the axial centerline. With this construction, fluid will flow from reservoir  452  into inlet port  474 , through filter member  482 , through a central opening  478   a  formed in separator plate  478  and thence into micro-channel  480  (see also  FIG. 85 ). By controlling the length, depth and width of the micro-channel  480 , the rate of fluid flow flowing outwardly of outlet  479  can be precisely controlled. In this regard, the micro-channel can take several forms as for example that illustrated in  FIG. 86  of the drawings and generally designated therein by the numeral  480   a . Where required for drug compatibility purposes, the micro channel  480   a  can be coated with a compatibility coating “C- 1 ” of the character previously described. This coating can be accomplished in several ways, including the plasma coating process earlier described herein. 
         [0224]    Turning once again to  FIGS. 71 ,  72  and  73 , 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  488  that is connected to the first portion  446  of housing  444  in the manner shown in the drawings. The proximal end  490   a  of administration line  490  of the administration set  488  is in communication with an outlet fluid passageway  492  which is formed in housing portion  446  in the manner best seen in  FIG. 73 . Disposed between the proximal and  490   a  and the distal end  490   b  of the administration line is a conventional gas vent and filter  496 . Provided at the distal end  490   b  of the administration line is a luer connector  498  of conventional construction (see  FIG. 71 ). 
         [0225]    To control fluid flow from the outlet  479  of the flow rate control means toward outlet passageway  492 , novel operating means are provided. This operating means here comprises a control knob assembly  500  that includes a finger gripping portion of  502  and a generally cylindrically shaped shank portion  504  that is rotatably received within a bore  506  formed in housing portion  446  ( FIG. 73 ). As indicated in  FIG. 75 , control knob assembly  500  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  446 . The control knob assembly is retained in position with a housing  446  by a retainer ring  505 . Shank portion  504  of the control knob assembly includes an axial flow passageway  508  that communicates with the earlier identified outlet flow passageway  492  via a stub passageway  509 . The flow passageway  508  also communicates with outlet  479  of flow rate control assembly  470  when the control assembly is in the “on” position shown in  FIG. 75 . In this position, fluid can flow from reservoir  452 , through outlet  456 , through flow rate control assembly  470 , into central passageway  508  of the control knob assembly and then toward the administration set via passageway  492 . As indicated in  FIGS. 76 and 78 , to guide the travel of the control knob assembly, the control knob assembly is provided with a protuberance  502   a  that travels within a groove  511  provided in the housing portion  446 . 
         [0226]    In using the apparatus of the invention, with the control knob assembly in the “off” position, the reservoir  452  of the bellows component  450  can be filled by filling means which comprises a conventional syringe having a needle adapted to pierce the pierceable septum  466  which is mounted within portion  446  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 is shown in  FIG. 73 . As the bellows member expands it will urge a telescopically movable volume indicator member  512  that is carried within a second portion  448  of the housing into engagement with the stored energy source causing it to compress. As the reservoir  452  fills with fluid from the filling syringe, any gases trapped within the reservoir will be vented to atmosphere via vent means “V” mounted in knob  502 . 
         [0227]    With the infusion apparatus interconnected with the patient&#39;s clothing by means of a spring clip assembly  518 , which is affixed to the side of the device housing in the manner shown in  FIGS. 72 and 75 , and with the administration set  488  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 member  460 , will tend to return to its starting configuration thereby controllably urging fluid flow outwardly of reservoir  452  via the flow rate control means of the invention, passageway  508  of the control knob assembly and delivery passageway  492  formed in housing portion  446 . As the fluid flows outwardly of the apparatus due to the urging of the stored energy means, the bellows structure  450  will be collapsed and at the same time member  512  will travel inwardly of housing portion  448 . Member  512 , which forms a part of the volume indicator means of the invention, includes a radially outwardly extending indicating finger  512   a  that is visible through a volume indicator window  514  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 ( FIGS. 71 and 72 ). Indicia  516 , which are provided on indicator window  514 , function to readily indicate to the caregiver the amount of fluid remaining within fluid reservoir  452 . 
         [0228]    As previously discussed, a number of beneficial agents can be introduced into reservoir  452  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. 
         [0229]    Referring next to  FIG. 87 , an alternate form of flow control means of the invention is there shown. This flow control means can be mounted within a modified housing  444  that will accommodate off-set, in-line input and output ports of the diameter shown in  FIGS. 77 and 78 . This latter flow control means functions to precisely control the rate of fluid flow from reservoir  452  toward the patient. In the form of the invention shown in  FIG. 87 , the flow control means comprises a flow control assembly generally designated in the drawings by the numeral  520 . Flow control assembly  520  here comprises a first component or inlet manifold  522  having an inlet port  524  that can be placed in communication of the outlet  456  of the fluid reservoir  452  and an outlet manifold  526  that can be interconnected with first component  522  by means of a pair of separator plates or components  528  and  529 . Outlet manifold component  526  has an outlet port  543  that is in communication with the outlet  542  of separator plate  529  and also in communication with the outlet of the apparatus. Intake manifold  522  has an inner surface  522   a  that is provided with a plurality of interconnected, imbedded capillaries  532 . Capillaries  532  are in communication both with inlet port  524  and with an outlet port  534  formed in the inlet manifold. Disposed adjacent manifold  522  is separator plate  528 . Separator plate  528  has an inner, uninterrupted surface  528   a  that is also provided with a plurality of imbedded capillaries  536  that are in communication with outlet port  534  formed in the inlet manifold. Fluid flowing from capillaries  532  flows into capillaries  536  via an inlet port  537  and then outwardly of separator plate  528  via an outlet port  536   a.    
         [0230]    Separator plate  529 , which is disposed intermediate separator plate  528  and outlet manifold  526 , has an inner, uninterrupted surface  529   a  that is provided with a plurality of interconnected capillaries  540  that receive the fluid flowing outwardly of outlet port  536   a . After the fluid flow through capillaries  540 , it will flow toward outlet  543  of outlet manifold  526  via an outlet port  542 . 
         [0231]    By controlling the length, width and depth of capillaries  532 ,  536 , and  540 , the rate of fluid flow flowing outwardly of outlet  543  can be precisely controlled. In this regard, it is to be understood that the capillaries of the flow control assembly can take several forms depending upon the end use of the fluid delivery device. 
         [0232]    Turning now to  FIG. 88 , still another form of flow control means of the invention is there shown. This flow control means can also be mounted within housing  444  in place of flow control assembly  470  and functions to precisely control the rate of fluid flow from reservoir  452  and toward the patient. In the form of the invention shown in  FIG. 88 , the flow control means comprises a flow control assembly generally designated in the drawings by the numeral  550 . Flow control assembly  550  here comprises a first component or inlet manifold  552  having an inlet port  554  that can be placed in communication with the outlet  456  of the fluid reservoir  452  and a second component or outlet manifold  556  that can be interconnected with intake manifold  552  by means of a separator component or plates  558  and  559 . Outlet manifold  556  has an outlet port  557  that is in communication with the outlet  560  of separator plate  559  and also in communication with the outlet of the apparatus. Intake manifold  552  has an inner surface  552   a  that is provided with a plurality of interconnected imbedded capillaries  562 . Capillaries  562  are in communication both with inlet port  554  and with an outlet port  564  formed in the inlet manifold. Disposed adjacent manifold  552  is a separator plate  558 . Separator plate  558  has an inner surface  558   a  that is provided with a plurality of imbedded capillaries  566  that are in communication with outlet port  564  formed in the inlet manifold. Fluid flowing from capillaries  562  flows into capillaries  566  via an inlet port  569  and then outwardly of separator plate  558  via an outlet port  567 . 
         [0233]    Separator plate  559 , which is disposed intermediate separator plate  558  and outlet manifold  556 , has an inner surface  559   a  that is provided with a plurality of interconnected capillaries  570  that receive the fluid flowing outwardly of outlet port  567 . After the fluid flows through capillaries  570 , it will flow toward outlet  557  of outlet manifold  556  via an outlet port  560 . 
         [0234]    As before, by controlling the length, width and depth of capillaries  562 ,  566 , and  570  the rate of fluid flow flowing outwardly of outlet  557  can be precisely controlled. 
         [0235]    Having now described the invention in detail in accordance with the requirements of the patent statutes, those skilled in this art will have no difficulty in making changes and modifications in the individual parts or their relative assembly in order to meet specific requirements or conditions. Such changes and modifications may be made without departing from the scope and spirit of the invention, as set forth in the following claims.