Abstract:
An apparatus for delivering fluids at precisely controlled rates to ambulatory patients. The invention comprises a housing having a fluid reservoir to contain fluids to be delivered to the patient, a novel stored energy membrane for expelling fluid from the reservoir and a unique flow control assembly in communication with the fluid reservoir for the precise infusion of pharmaceutical fluids to ambulatory patients at precisely controlled rates. The flow control assembly includes a novel rate control member having a plurality of fluidic micro-channels through which the fluid is selectively directed.

Description:
This is a Non-Provisional Application claiming the benefit of co-pending Provisional Application No. 60/654,552 filed Feb. 17, 2005. 
    
    
     BACKGROUND OF THE INVENTION  
       [0001]     1. Field of the Invention  
         [0002]     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. The apparatus includes both novel vial assembly fill means for filling the reservoir of the device with medicinal agents and unique flow rate control means for precisely controlling the rate of flow of medicinal agents toward the patient.  
         [0003]     2. Discussion of the Invention  
         [0004]     Many medicinal agents require an intravenous route for administration thus bypassing the digestive system and precluding degradation by the catalytic enzymes in the digestive tract and the liver. The use of more potent medications at elevated concentrations has also increased the need for accuracy in controlling the delivery of such drugs. The delivery device, while not an active pharmacologic agent, may enhance the activity of the drug by mediating its therapeutic effectiveness. Certain classes of new pharmacologic agents possess a very narrow range of therapeutic effectiveness, for instance, too small a dose results in no effect, while too great a dose results in toxic reaction.  
         [0005]     In the past, prolonged infusion of fluids has generally been accomplished using gravity flow methods, which typically involve the use of intravenous administration sets and the familiar bottle suspended above the patient. Such methods are cumbersome, imprecise and require bed confinement of the patient. Periodic monitoring of the apparatus by the nurse or doctor is required to detect malfunctions of the infusion apparatus.  
         [0006]     Devices from which liquid is expelled from a relatively thick-walled bladder by internal stresses within the distended bladder are well known in the prior art. Such bladder, or “balloon”-type, devices are described in U.S. Pat. No. 3,469,578, issued to Bierman, and in U.S. Pat. No. 4,318,400, issued to Perry. The devices of the aforementioned patents also disclose the use of fluid flow restrictors external of the bladder for regulating the rate of fluid flow from the bladder.  
         [0007]     The prior art bladder-type infusion devices are not without drawbacks. Generally, because of the very nature of the bladder or “balloon” configuration, the devices are unwieldy and are difficult and expensive to manufacture and use. Further, the devices are somewhat unreliable and their fluid discharge rates are frequently imprecise.  
         [0008]     The apparatus of the present invention overcomes many of the drawbacks of the prior art by eliminating the bladder and making use of elastomeric films and similar materials, which, in cooperation with a base, define a fluid reservoir that contains the fluid which is to be dispensed. The elastomeric film membrane controllably forces fluid within the reservoir toward the reservoir outlet.  
         [0009]     The elastomeric film materials used in the apparatus of the present invention, as well as various alternate constructions of the apparatus, are described in detail in U.S. Pat. No. 5,205,820 issued to one of the present inventors. Therefore, U.S. Pat. No. 5,205,820 is hereby incorporated by reference in its entirety as though fully set forth herein. U.S. Pat. No. 6,086,561 also issued to one of the present inventors describes various alternate constructions and modified physical embodiments of the invention. This latter patent is also hereby incorporated by reference in its entirety as though fully set forth herein.  
         [0010]     The apparatus of the present invention can be used with minimal professional assistance in an alternate health care environment, such as the home. By way of example, the apparatus can be used for the continuous infusion of antibiotics, hormones, steroids, blood clotting agents, analgesics, and like medicinal agents. Similarly, the devices can be used for I-V chemotherapy and can accurately deliver fluids to the patient in precisely the correct quantities and at extended microfusion rates over time.  
         [0011]     The apparatus of the present invention, which includes a unique vial fill assembly for filling the reservoir of the apparatus, also includes a novel fluid flow rate control assembly for precisely controlling the rate of fluid flow from the apparatus reservoir to the patient. More particularly, the fluid flow rate control assembly comprises a novel flow control plate that is positioned intermediate the apparatus reservoir and the administration set that carries the fluid to the patient. The flow control plate is provided with a plurality of elongated fluidic flow control micro-channels that are in communication with a rate selector member that is rotatably carried by the apparatus housing. Rotation of the rate selector member places a selected one of the flow control micro-channels in communication with the administration set and precisely controls the rate of fluid flow toward the patient.  
         [0012]     A number of fluid flow rate control devices for use in controlling the rate of fluid flow from a fluid supply toward a patient have been suggested in the past. Exemplary of such prior art devices are those described in U.S. Pat. No. 6,095,491 issued to one of the present inventors. This patent describes a readily adjustable flow rate control device having a movable flow control member which includes a plurality of spaced-apart flow restrictors which are adapted to be selectively positioned intermediate a fluid flow path extending between a fluid supply line and a fluid delivery line. In one form of the invention the flow restrictors take the form of a plurality of porous rate control frits which can be selectively moved into index with the fluid flow path.  
         [0013]     Another prior art fluid flow control device is described in U.S. Pat. No. 5,499,968 issued to Milijasevic et al. This patent describes various constructions of in-line fluid flow controllers which are adapted primarily for use with a conventional fluid administration set of the type used for infusion of fluid into the body of a patient. In one embodiment, the Milijasevic et al., fluid flow controllers comprise a housing, a chamber therein and an inlet to and an outlet from the chamber. The housing is adapted to receive therewithin at least one flow restrictor having an orifice configured to control the rate of fluid flow therethrough and into the body of the patient. In an alternate embodiment, the controller is adapted with a series of fluid passageways which are linked with a series of orifice plates held in position by a wedge.  
         [0014]     Another somewhat similar prior art fluid flow rate control device is disclosed in U.S. Pat. No. 4,781,698 issued to Parren. The Parren device comprises a conventional roller clamp which is connected to a drop chamber. The drop chamber controls the size of the droplets flowing toward the roller clamp, and the roller clamp controls the rate of fluid flow through the delivery line. The Parren apparatus includes a disk having a discharge opening which is selectively alignable with one or more drop tubes and includes a flexible edge or wiper means formed around the discharge opening to provide a seal between the disk and the selected drop tube to prevent fluid from seeping between the disk and the mounting plate.  
         [0015]     A common drawback of many of the prior art flow controllers is that the controllers are often complex in construction, are difficult and costly to manufacture, are often somewhat unreliable and lack ease of adjustability to quickly and expeditiously vary the rate of fluid through the device. The rate control assembly of the present invention overcomes these drawbacks by providing a highly precise flow rate control assembly which is particularly well-suited for precisely dispensing medicaments to a patient in a home care environment.  
       SUMMARY OF THE INVENTION  
       [0016]     It is an object of the present invention to provide an apparatus for delivering fluids at a precisely controlled rate which comprises a fluid dispensing component having a fluid reservoir for containing the fluids to be delivered and a reservoir fill component which can be removably interconnected with the fluid dispensing component. More particularly, it is an object of the invention to provide such an apparatus in which the reservoir fill component can be used to controllably fill the reservoir of the dispensing component and in which the dispensing component can be used for the precise infusion of pharmaceutical fluids to an ambulatory patient at precisely controlled rates.  
         [0017]     It is another object of the invention to provide an apparatus of the aforementioned character which is highly reliable and easy-to-use by lay persons in a non-hospital environment.  
         [0018]     Another object of the invention is to provide an apparatus which can readily be filled in the field shortly prior to use using the novel reservoir fill component which can be removably interconnected to the lower surface of the base of the fluid dispenser.  
         [0019]     Another object of the invention is to provide an apparatus of the aforementioned character, which includes a novel fluid flow rate control assembly disposed intermediate the fluid reservoir outlet and the outlet port of the device.  
         [0020]     Another object of the invention is to provide an apparatus which includes a fluid flow rate control assembly as described in the preceding paragraph which includes a novel flow control plate that is provided with a plurality of elongated fluidic flow control micro-channels that are in communication with a rate selector member that is rotatably carried by the apparatus housing. Rotation of the rate selector member places a selected one of the flow control micro-channels in communication with the medicament dispenser and in communication with a patient to precisely control the rate of fluid flow toward the patient.  
         [0021]     Another object of the invention is to provide an apparatus which includes a novel fluid flow rate control assembly as described in the preceding paragraphs in which the fluidic flow control micro-channels comprise meandering micro-channels of various lengths, depths, widths and configurations.  
         [0022]     Another object of the invention is to provide a device of the character described which includes priming means for priming the various fluid passageways of the device and purging the fluid passageways of gases that may be contained therein prior to the delivery of the medicinal fluids to the administration line of the device. More particularly, an object of the invention is to provide such a device which includes a flow control plate that is provided with a priming channel that is in communication with the plurality of elongated fluidic flow control channels formed in a rate control member and is also in communication with the rate selector member that is rotatably carried by the device housing.  
         [0023]     Another object of the invention is to provide an apparatus which includes a novel fluid flow rate control assembly of the class described in which the flow rate selector member can be locked against rotation once a particular fluidic flow control channel is selected.  
         [0024]     Another object of the invention is to provide a unique fill assembly for use in controllably filling the fluid reservoir of the apparatus.  
         [0025]     Another object of the present invention is to provide an apparatus of the aforementioned character in which the fill assembly comprises a vial assembly that can be pre-filled with a wide variety of medicinal fluids.  
         [0026]     Another object of the present invention is to provide a fill assembly of the type described in the preceding paragraph in which the pre-filled vial assembly is partially received within the housing of a novel syringe assembly that can be operably interconnected with the housing of the fluid dispensing apparatus using a sterile coupling.  
         [0027]     Another object of the invention is to provide a novel fill assembly for use with the fluid dispensing apparatus which is easy to use, is inexpensive to manufacture, and one which maintains the fill assembly in an aseptic condition until time of use.  
         [0028]     Other objects of the invention will become more apparent from the discussion which follows. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0029]      FIG. 1  is a generally perspective view of one form of the fluid delivery apparatus of the invention.  
         [0030]      FIG. 2  is a generally perspective view of the forward portion of the apparatus housing shown in  FIG. 1  illustrating the administration set storage compartment of the apparatus in an open configuration.  
         [0031]      FIG. 3  is an enlarged, longitudinal, cross-sectional view of the fluid delivery apparatus of the invention shown in  FIG. 1 .  
         [0032]      FIG. 4  is a generally perspective, fragmentary, exploded view of a portion of the embodiment of the invention shown in  FIG. 1 , illustrating the path of fluid flow through the apparatus.  
         [0033]      FIG. 5  is a generally perspective, exploded view of the forward portion of the apparatus housing showing the rate control housing exploded away from the administration set storage compartment.  
         [0034]      FIG. 6  is a generally perspective, exploded view of the rearward, reservoir defining portion of the apparatus.  
         [0035]      FIG. 7  is an enlarged, generally perspective, exploded view of the fluid flow control portion of the apparatus of one form of the invention.  
         [0036]      FIG. 8  is a plan view of the rear face of the reservoir housing closure member showing the configuration of the fluid diffusion component of the apparatus of the invention.  
         [0037]      FIG. 9  is a cross-sectional view taken along lines  9 - 9  of  FIG. 8 .  
         [0038]      FIG. 10  is a top plan view of the reservoir closure member shown in  FIG. 8 .  
         [0039]      FIG. 11  is a front view of the reservoir closure member shown in  FIG. 8 .  
         [0040]      FIG. 12  is a cross-sectional view taken along lines  12 - 12  of  FIG. 11 .  
         [0041]      FIG. 13  is fragmentary, cross-sectional view illustrating the fluid flow path through the fluid diffusion component and into the fluid flow rate control subassembly of the apparatus of the invention.  
         [0042]      FIG. 14  is a cross-sectional view taken along lines  14 - 14  of  FIG. 15 .  
         [0043]      FIG. 15  is a front view of the rate control housing of the apparatus and a front view of a portion of one form of the flow control assembly of the apparatus of the invention.  
         [0044]      FIG. 16  is a top plan view of one form of the flow rate control subassembly of the fluid flow control assembly of the apparatus of the invention.  
         [0045]      FIG. 17  is front view of the flow rate control subassembly shown in  FIG. 16 .  
         [0046]      FIG. 18  is an enlarged, cross-sectional view taken along lines  18 - 18  of  FIG. 16 .  
         [0047]      FIG. 19  is a top plan view of the base of the flow rate control subassembly shown in  FIG. 17 .  
         [0048]      FIG. 19A  is a fragmentary cross-sectional view of one of the fluidic micro channels of one form of the flow control means of the invention.  
         [0049]      FIG. 20  is a front view of the base of the flow rate control subassembly shown in  FIG. 19 .  
         [0050]      FIG. 21  is a left end view of one form of the rate control cylinder of the fluid flow control assembly of the apparatus of the invention.  
         [0051]      FIG. 22  is a cross-sectional view taken along lines  22 - 22  of  FIG. 21 .  
         [0052]      FIG. 23  is a right end view of the rate control cylinder of the fluid flow control assembly of the apparatus of the invention.  
         [0053]      FIG. 24  is a cross-sectional view taken along lines  24 - 24  of  FIG. 22 .  
         [0054]      FIG. 25  is a cross-sectional view taken along lines  25 - 25  of  FIG. 22 .  
         [0055]      FIG. 26  is a rear view of the rate control knob of the selector means of the apparatus of the invention.  
         [0056]      FIG. 27  is a side view of the rate control knob shown in  FIG. 26 .  
         [0057]      FIG. 28  is a front view of the rate control knob shown in  FIG. 26 .  
         [0058]      FIG. 29  is a top plan view of a portion of one form of the fluid flow control assembly of the apparatus of the invention.  
         [0059]      FIG. 30  is a cross-sectional view taken along lines  30 - 30  of  FIG. 29 .  
         [0060]      FIG. 31  is a front view of the portion of the fluid flow control assembly shown in  FIG. 29 .  
         [0061]      FIG. 32  is a cross-sectional view taken along lines  32 - 32  of  FIG. 31 .  
         [0062]      FIG. 33  is a side view of the portion of the fluid flow control assembly shown in  FIG. 29 .  
         [0063]      FIG. 34  is a bottom view of the portion of the fluid flow control assembly shown in  FIG. 29 .  
         [0064]      FIG. 35  is a fragmentary rear view of one form of the control knob and the locking means of the fluid flow control assembly of the apparatus of the invention.  
         [0065]      FIG. 36  is a cross-sectional view taken along lines  36 - 36  of  FIG. 35 .  
         [0066]      FIG. 37  is a cross-sectional view similar to  FIG. 36 , but showing the locking means and a locked configuration.  
         [0067]      FIG. 38  is a bottom view of the locking means of the invention shown in  FIG. 36 .  
         [0068]      FIG. 39  is a bottom view similar to  FIG. 38 , but showing the locking means of the invention in an unlocked, retracted configuration.  
         [0069]      FIG. 40  is a generally perspective, exploded view of one form of the fill means, or filling syringe of the apparatus of the invention for use in the filling the apparatus reservoir.  
         [0070]      FIG. 41  is an exploded, longitudinal cross-sectional view of one form of the filling syringe and cooperating fill vial of the apparatus of the invention.  
         [0071]      FIG. 42  is a cross-sectional view similar to  FIG. 41 , but showing the fill vial mated with the filling syringe.  
         [0072]      FIG. 43  is a generally perspective, exploded view of an alternate form of fill means, or filling syringe of the apparatus of the invention.  
         [0073]      FIG. 44  is a longitudinal, cross-sectional, exploded view of the filling syringe, cooperating fill vial and pusher means of one form of the fill means of the invention.  
         [0074]      FIG. 45  is a longitudinal cross-sectional view, similar to  FIG. 44 , but showing the components in an assembled configuration.  
         [0075]      FIG. 46  is an enlarged, longitudinal, cross-sectional view similar to  FIG. 3 , but showing the alternate form of fill means, mated with the fluid delivery apparatus of the invention.  
         [0076]      FIG. 47  is a generally perspective, exploded view of the forward portion of an alternate form of the apparatus housing of the invention showing the rate control housing exploded away from the rearward, reservoir defining portion of the apparatus.  
         [0077]      FIG. 48  is a top plan view of the rate control housing of the apparatus.  
         [0078]      FIG. 49  is a front view of the rate control housing of the apparatus.  
         [0079]      FIG. 50  is a cross-sectional view taken along lines  50 - 50  of  FIG. 49 .  
         [0080]      FIG. 51  is a top plan view of an alternate form of the rate control cylinder of the fluid flow control assembly of the apparatus of the invention.  
         [0081]      FIG. 52  is a left-end view of the rate control cylinder shown in  FIG. 51 .  
         [0082]      FIG. 53  is a right-end view of the rate control cylinder shown in  FIG. 51 .  
         [0083]      FIG. 54  is a cross-sectional view taken along lines  54 - 54  of  FIG. 51 .  
         [0084]      FIG. 55  is a top plan view of one form of the flow rate control subassembly of the fluid flow control assembly of the alternate form of the apparatus of the invention.  
         [0085]      FIG. 56  is a cross-sectional view taken along lines  56 - 56  of  FIG. 55 .  
         [0086]      FIG. 57  is an enlarged cross-sectional view taken along lines  57 - 57  of  FIG. 55 .  
         [0087]      FIG. 58  is a top plan view of the base, or rate control member of the flow rate control subassembly shown in  FIG. 55 .  
         [0088]      FIG. 59  is a side view of an alternate form of flow rate control assembly of the present invention.  
         [0089]      FIG. 60  is a top plan view of the flow rate control assembly of the apparatus illustrated in  FIG. 59 .  
         [0090]      FIG. 61  is an enlarged cross-sectional view taken along lines  61 - 61  of  FIG. 60 .  
         [0091]      FIG. 62  is an enlarged cross-sectional view taken along lines  44 - 44  of  FIG. 60 .  
         [0092]      FIG. 63  is a top plan view of the cover member of the flow rate control assembly of the apparatus illustrated in  FIG. 59 .  
         [0093]      FIG. 64  is a view taken along lines  64 - 64  of  FIG. 63 .  
         [0094]      FIG. 65  is a bottom plan view of the cover member of the flow rate control assembly of the apparatus illustrated in  FIG. 59 .  
         [0095]      FIG. 66  is an enlarged view taken along lines  64 - 64  of  FIG. 61 .  
         [0096]      FIG. 67  is an enlarged view taken along lines  67 - 67  of  FIG. 65 .  
         [0097]      FIG. 68  is an enlarged view taken along lines  68 - 68  of  FIG. 63 .  
         [0098]      FIG. 68A  is a fragmentary cross-sectional view similar to  FIG. 68 , but showing the compression of an elastomeric cover port as the rate control assembly is mated with the housing.  
         [0099]      FIG. 69  is an enlarged view taken along lines  69 - 69  of  FIG. 65 .  
         [0100]      FIG. 70  and is a side view of the base member of the flow rate control assembly of this latest form of the invention.  
         [0101]      FIG. 71  is a bottom plan view of the base member the flow rate control assembly of this latest form of the invention.  
         [0102]      FIG. 72  is a generally tabular view illustrating the fluidic properties of one form of the fluid rate control member, or rate control chip of the form of the flow rate control device shown in  FIG. 47 . 
     
    
     DESCRIPTION OF THE INVENTION  
       [0103]     Referring to the drawings and particularly to  FIGS. 1 through 4 , one form of the fluid dispensing apparatus of the invention is there shown and generally designated by the numeral  50  (see  FIG. 1 ). As best seen in  FIG. 3 , the apparatus here comprises four major cooperating subassemblies namely, a reservoir subassembly  52  for containing the fluid to be dispensed to the patient, a flow control subassembly  54  for controlling the flow of fluid from the reservoir subassembly to the patient ( FIG. 3 ), a fluid dispensing subassembly  56  ( FIG. 2 ) for dispensing the fluid to the patient and a fill assembly  58  for controllably filling the reservoir with the fluid to be dispensed to the patient ( FIG. 3 ). The details of each of these subassemblies, which are carried by a housing  60 , will be discussed in greater detail in the paragraphs which follow.  
         [0104]     Considering first the reservoir subassembly shown in  FIG. 6 , this subassembly includes a base assembly  62 , a stored energy means, shown here as a distendable membrane  64 , and a cover  66  for enclosing the stored energy source. The base assembly includes an ullage substrate  68  and a membrane capture housing  70  having a bottom opening  72  which receives the distendable membrane engaging element or protuberance  74  of base assembly  62  (see also  FIG. 3 ). Distendable membrane  64  and ullage substrate  68  cooperate to define a fluid reservoir  75  for containing fluid to be dispensed to the patient. Reservoir  75  is provided with an inlet  75   a  for permitting fluid flow into said fluid reservoir and an outlet  75   b  for permitting fluid flow from said fluid reservoir.  
         [0105]     Referring particularly to  FIGS. 3 and 6 , it can be seen that the ullage substrate  68  is provided with fill assembly receiving means shown here as a generally cylindrically-shaped receiving chamber  77  for receiving the connector portion of the fill assembly  58  ( FIG. 3 ). Provided within chamber  77  is a pierceable septum  79  as well as the valve means of the invention, the nature and purpose of which will presently be discussed ( FIG. 3 ).  
         [0106]     Considering next the important flow control means of the invention that comprises the novel flow rate control subassembly  54 . This novel subassembly includes a novel flow rate control means that comprises a rate control base, plate or substrate  80  and an interconnected rate control cover  82  ( FIG. 4 ). As best seen in  FIGS. 4 and 20 , rate control base, or plate  80  is uniquely provided with a plurality of fluidic micro-channels identified in the drawings as  84 ,  86 ,  88 ,  90 ,  92 ,  94  and  96 . Each of the fluidic micro-channels is in communication with an inlet  98  via a filter means, or filter “F” and passageway  100  and each is provided with an outlet  102 ,  104 ,  106 ,  108 ,  110 ,  112  and  114  respectively. These outlets align with cover outlet ports  82   a,    82   b,    82   c,    82   d,    82   e,    82   f  and  82   g  respectively (see  FIG. 17 ) when the flow rate control assembly is assembled together in the manner illustrated in  FIG. 7 . Similarly, cover inlet port  82   h  aligns with rate control plate inlet  98  in the manner illustrated in  FIG. 17 . As will be presently described, each of the outlet ports formed in cover  82  can be placed in selective communication with the fluid dispensing means of the apparatus ( FIG. 2 ) by controlled rotation of the selector member  120  of the rate control means of the invention the details of construction of which will presently be described.  
         [0107]     It is to be understood that the micro-channels formed in rate control plate  80  may be of different sizes, lengths, widths, depths and configurations as shown by  FIG. 19 . Further, the flow control micro-channels may be rectangular in cross-section, 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. Additionally, as shown in  FIG. 19A , the surface characteristics of the micro channels may be tailored to impart desired flow characteristics (for example, see surface coating “C”).  
         [0108]     As indicated in  FIG. 7 , the flow rate control housing  122  of the flow control means is provided with an upraised portion  122   a  that defines an elongated, generally cylindrically-shaped chamber  124 . Receivable within chamber  124  is the second portion of the flow rate control means of the invention, namely the selector means, which comprises previously identified selector member  120 .  
         [0109]     As best seen by referring to  FIGS. 22 and 26 , this important selector means of the invention also includes a cooperating control knob  126  which is used to controllably rotate selector member  120 . As indicated in  FIGS. 7, 14 ,  22  and  25 , selector member  120  is provided with an axially-extending fluid flow passageway  128  and a plurality of radially-extending passageways  120   a,    120   b,    120   c,    120   d,    120   e,    120   f  and  120   g  that communicate with passageway  128 . In a manner presently to be described, rotation of selector member  120  within chamber  124  as a result of rotation of control knob  126  will permit a selected one of the plurality of radially-extending passageways formed in selector member  120  to be aligned with a selected one of the outlet ports of cover  82  and also with a selected one of the outlets of the fluidic micro-channels formed in rate control plate  80 . As indicated in  FIGS. 22 and 24 , selector member  120  is provided with an outlet passageway  132 , which communicates with axially-extending passageway  128  and also with a circumferentially-extending passageway  134 . As indicated in  FIG. 22 , surrounding member  120  is sealing means, shown here as an elastomeric sleeve  12   s  which functions to seal member  120  relative to the housing. Circumferentially-extending passageway  134  communicates with an outlet port  136  formed on protuberance  122   a  (see  FIG. 7 ), which, in turn, communicates with the fluid delivery line  138  of the fluid dispensing means ( FIGS. 2, 7  and  15 ).  
         [0110]     As indicated in  FIGS. 7, 22  and  23 , the proximal end  121  of selector member  120  is beveled and is provided with a plurality of circumferentially-spaced driven teeth  140 . Teeth  140  mesh with a plurality of circumferentially-spaced driving teeth  142  formed on the inner beveled surface of a flange  144  of control knob  126  (see  FIGS. 26 and 27 ). With this construction, when the shank portion  145  of control knob  126  is mated with flow control cover in the manner shown in  FIG. 14 , rotation of the control knob will impart rotation to the selector member  120 . As previously mentioned, controlled rotation of selector member  120  will cause one of the radially-extending passageways formed within the selector member to be moved into fluid communication with a selected one of the outlets of the rate control channels formed in the rate control plate  80 . As indicated in  FIGS. 1 and 2 , control knob  126  is provided with indicia “I” for indicating fluid flow rate toward the fluid delivery means of the apparatus.  
         [0111]     Before further discussion of the operation of the selector means of the invention, the details of the construction of the rate control plate  80  and the various methods of making the rate control plate will now be considered. With respect to materials, the most appropriate materials for constructing the rate control plate are medical grade polymers. These types of polymers include thermoplastics, duroplastics, elastomers, polyurethanes, acrylics, silicones and epoxies. In other variations, the materials used for the flow control plate may be made of glass, silica or silicon. In further variations, the flow control component may be made of metals or inorganic oxides.  
         [0112]     Using the foregoing materials, there are several ways that the flow control channels can be made. These include injection molding, injection-compression molding, hot embossing, casting and laser ablation. The techniques used to make these imbedded fluid channels are now commonplace in the field of microfluidics, which gave rise to the lab-on-a-chip, bio-MEMS and micro-total analysis systems (μ-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.  
         [0113]     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 μm. 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 or embossing tool is fabricated, the polymer of choice may be injection molded or embossed to yield the desired part with imprinted channels.  
         [0114]     Alternatively, channels can be made by one of a variety of casting processes. In general, a liquid plastic resin, for example, a photopolymer can be applied to the surface of a metal master made by the techniques described in the preceding paragraph and then cured via thermal or ultraviolet (UV) means. After hardening, the material is then “released” from the mold to yield the desired part. Additionally, there are similar techniques available that utilize CAD data of the desired channel configuration and direct laser curing of a liquid monomer to yield a polymerized and solidified part with imbedded channels. This process is available by contract, from, by way of example, MicroTEC, GmbH of Duisburg, Germany.  
         [0115]     In order to seal the flow control channels, a planar top plate may be used. In this instance, the channel system may be sealed with a top plate, which is here defined as any type of suitable cover that functions to seal the channel. The top plate may be sealably interconnected with the base plate which contains the flow channels by several means, including thermal bonding, sonic welding, laser welding, adhesive bonding and vacuum application.  
         [0116]     Thermal bonding may be performed by using a channel base plate material and planar top cover that are made of similar polymeric materials. In this case the two substrates are placed in contact with one another, confined mechanically and heated to 2-5° C. above their glass transition temperature. Following a holding period sufficient enough for the polymer molecules of the two surfaces to interpenetrate with one another, the temperature is slowly reduced and a stress free bonded interface with imbedded micro-channels is yielded.  
         [0117]     Additionally, the top plate may be bonded to the base plate through the use of one or more suitable bonding materials or adhesives. The bonding material or adhesive may be of the thermo-melting variety or of the liquid or light curable variety. For thermo-melting adhesives, the adhesive material is melted into the two apposed surfaces, thereby interpenetrating these surfaces and creating a sealed channel structure.  
         [0118]     Further, liquid curable bonding materials or adhesives and light curable bonding materials or adhesives may be applied to one of the surfaces, for example the top plate. Subsequently, the other surface is brought into contact with the coated surface and the adhesive is cured by air exposure or via irradiation with a light source. Liquid curable bonding materials or adhesives may be elastomeric, for example, thermoplastic elastomers, natural or synthetic rubbers, polyurethanes, and silicones. Elastomeric bonding materials may or may not require pressure to seal the channel system. They may also provide closure and sealing to small irregularities in the apposed surfaces of the channel system.  
         [0119]     A channel system may also be formed and sealed in cases where two surfaces are being joined and one of the surfaces has one or more apertures. In order to promote bonding between these two surfaces, a vacuum may be applied to the apertures. Bonding may then be accomplished by thermal methods or after previously having applied a bonding material or adhesive.  
         [0120]     While the rate control plate can be constructed in various sizes, a rate control chip which is rectangular in shape and approximately 11 cm long and approximately 5 cm wide is suitable for the present application. Similarly, while the depth of the channels can vary depending upon the end use of the device, as a general rule the depth of the channels is on the order of approximately 1-1000 μm.  
         [0121]     As previously mentioned, the cross section of the set of channels may vary in area over the members of the set of individual channels so as to achieve the specified flow rate of a particular channel. The cross section may also vary over the length of any particular channel so as to achieve the specified flow rate for the particular channel. Some examples of typical channel cross sections are square, rectangular, elliptical, circular, semi-circular and semi-elliptical. Channel cross sections may also be more complicated than those noted explicitly here.  
         [0122]     A typical chip will be able to deliver fluid at multiple specified flow rates as, for example 0.25, 0.5, 1.0, 2.0 5.0 ml/hr. and greater for optimum performance, the flow rate should be constant and within 10% of the desired specified value at room temperature.  
         [0123]     In operation, the flow through the flow control channels is controlled by taking advantage of the viscous drag imposed on the moving fluid by the walls of the channels. For a given imposed pressure and channel cross section, the longer the channel the smaller the flow rate. The pressure required to achieve the desired flow rates in the flow channels is preferably in the range of from 0.01 to 1 ATM. However, for some applications it may be desirable to exceed these limits.  
         [0124]     The path that the micro-channels take in any given rate control plate may be straight, a single meander or two or more meanders. The turns of the meanders or serpentines may be of any angle from approximately 45° to approximately 220°. The runs of straight path between turns of the meanders may be of any length that the chip can accommodate, but these straight runs would typically be from 50 μm to 500 μm in length.  
         [0125]     Another important feature of the invention resides in the provision of locking means for locking the selector knob in position after a particular fluid flow micro-channel has been selected through rotation of the selector knob. As indicated in  FIGS. 26 and 35 , flange portion  144  of control knob  126  is provided with a plurality of circumferentially-spaced-apart indexing cavities  146 . Cavities  146  are adapted to receive the end of the outwardly extending finger portion  150   a  of a locking member  150  that is rotatably carried by flow control housing  122  for rotation by means of a physician&#39;s key  151  (see  FIG. 7 ) between a first locked position shown in  FIG. 38  and a second retracted position shown in  FIG. 39 . In the present form of the invention, the physician&#39;s key is provided with spaced-apart tangs  151   a  that are receivable within the spaced-apart bores  150   c  formed in locking member  150  (see  FIGS. 7, 38  and  39 ). Once the end  150   a  of the locking member  150  is in the retracted position, novel release means are provided to permit knob  126  to be rotated to another position. In the present form of the invention this release means comprises a release assembly that is carried by flow control housing  122  in the manner best seen in  FIGS. 7 and 36 . Release assembly  154  (See  FIGS. 4, 7 ,  36  and  37 ) here comprises a push member  156  that can be pushed downwardly in the manner shown in  FIG. 37  against the urging of a coil spring  158 . Disposed within push member  156  is a knob-locking member  160  which includes a shank portion  160   a  and an outwardly extending base portion  160   b  ( FIG. 7 ). When push member  156  is in the upper position shown in  FIG. 36 , the outboard portion  161  of the base portion extends into an indexing cavity  146   a  formed in the control knob that is spaced 180° from the indexing cavity  146   b  that receives the extremity of arm  150   a  of locking member  150 . When the push member is pushed into its downward position shown in  FIG. 37 , outboard portion  161  of the base portion moves from indexing cavity  146   b  into a circumferentially-extending groove  153  formed in control knob  126  (see  FIGS. 35 and 37 ). When outboard portion  161  is moved into groove  153 , knob  126  can be freely rotated to impart rotation to selector member  120  so as to permit another one of the plurality of radially-extending passageways formed in selector member  120  to be aligned with a selected one of the outlet ports of cover  82  and also with a selected one of the outlets of the fluidic micro-channels formed in rate control plate  80 . Once knob  126  has been rotated into the desired position the downward pressure exerted, on member  156  is released causing spring  158  to once again move outboard portion  161  of the release means into a selected indexing cavity formed in knob  126  thereby once again locking the control knob against rotation. This done, using the physicians key, the caregiver can once again rotate member  150  into the locking position shown in  FIG. 38 . Through manipulation of the release means of the invention and the control knob in the manner previously described, it is apparent that the caregiver can select the desired rate of fluid flow from reservoir  75  to the patient via the administration set  163  of the fluid dispensing means ( FIG. 2 ).  
         [0126]     Consider next one form of the fill assembly  58  for controllably filling the reservoir with the fluid to be dispensed to the patient. As previously discussed and as shown in  FIG. 3 , ullage substrate  68  is provided with fill assembly receiving means shown here as cylindrically-shaped receiving chamber  77  that is adapted to receive in an aseptic condition the connector portion of the fill assembly  58 . As illustrated in  FIGS. 40 through 42 , one form of the fill assembly of the invention comprises a syringe-type fill component  166  which includes a hollow housing  168  that is provided with a chamber  170  ( FIG. 41 ) for telescopically receiving a medicament containing fill vial container  172  ( FIG. 42 ), the construction of which will presently be described.  
         [0127]     An elongated support  174 , which is mounted within chamber  170  of component  168 , includes threaded end portions  176  and  178  and a central flow passageway  180 . Support  174  carries at one end a hollow needle  182  having a flow passageway which communicates, via passageway  180 , with the flow passageway of a second needle or cannula  184  that is carried interiorly of the connector portion  186  of the fill means, or fill assembly  168 . Portion  176  of support  174  is threadably interconnected within connector portion  186  and is sealed with respect thereto by means of an O-ring  188  ( FIG. 41 ). Second cannula  184  is adapted to pierce the earlier identified septum  79  when the syringe assembly is operably interconnected with the base assembly  62  in the manner shown in  FIG. 3 . Septum  79  can be either a slit septum or a solid septum and is preferably constructed from an elastomeric material such as a silicone rubber. It is to be understood that a mechanical check valve can also serve as a septal interface. Such a valve is commercially available from C. R. Bard of Murray Hill, N.J.  
         [0128]     Referring particularly to  FIG. 41  of the drawings, the medicament containing fill vial  172  of this form of the invention, includes a body portion  172   a,  having a fluid chamber  190  for containing the injectable fluid medicament “F”. Chamber  190  is provided with a first open end  190   a  and second closed end  190   b.  First open end  190   a  is sealably closed by closure means here provided in the form of an externally threaded elastomeric plunger  192  which is telescopically movable within chamber  190  from a first location wherein the plunger is disposed proximate first open end  190   a  to the second, device-fill location, wherein the plunger is disposed proximate second closed end  190   b.    
         [0129]     After removal of a closure member  196  from the syringe assembly ( FIG. 40 ), vial  172  can be inserted into chamber  170 . As the fill vial is so introduced and the plunger  192  is threadably interconnected with threaded end  178  of support  174 , the sharp end of the elongated needle  182  will pierce the central wall  182   a  of the elastomeric plunger in the manner shown in  FIG. 42 . Following removal of cover member  198 , which covers connector portion  186  of the syringe assembly ( FIG. 40 ), the assembly shown in  FIG. 41  of the drawings can be mated with the fluid dispenser in the manner shown in  FIG. 3 . This done, the gripping fingers  200  can be moved from a retracted position to the extended position shown in  FIGS. 41 and 42 .  
         [0130]     With the syringe fill assembly of the invention mated with the fluid dispenser in the manner shown in  FIG. 3 , the caregiver can grip the fingers  200  with his or her fingers and can exert an inward pressure on vial  172  causing the vial to move inwardly of chamber  170 . A continuous movement of the vial into chamber  170  will cause the structural support  174  to move the elastomeric plunger inwardly of the vial chamber  190  in a direction toward the second or closed end  190   b  of the vial chamber. As the plunger is moved inwardly of the vial, the fluid “F” ( FIG. 41 ) contained within the vial chamber will be expelled therefrom into the hollow elongated needle  180  (See  FIG. 42 ). The fluid will then flow into hollow needle  184  which has pierced septum  79  and, as best seen in  FIG. 3 , will then flow past the valve means which is here shown as a conventional umbrella type check valve  204 . The fluid will flow into inlet passageway  206  and then into reservoir  75 .  
         [0131]     A number of beneficial agents can be contained within vial container  172  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 prevention of diseases or the maintenance of the good health of the patient.  
         [0132]     As the fluid flows into reservoir  75 , it will exert an inward pressure on the distendable membrane  64  distending it from the position shown in the solid lines in  FIG. 3  to the position shown in the phantom lines in  FIG. 3 . Distendable membrane  64  can be in the form of a single pre-stressed or unstressed isotropic, elastomeric distendable membrane, or it can comprise a laminate assemblage made up of a plurality of initially generally planar distendable elements or films.  
         [0133]     As indicated by  FIG. 3 , upstanding tongue  62   a  of base  62  extends completely about the perimeter of the base and is closely receivable within a groove  70   a  of capture housing  70 . When the ullage substrate and the membrane capture housing are assembled in the manner shown in  FIG. 3 , the periphery of distendable membrane  64  will be securely clamped within groove  70   a  by tongue  62   a.  After the parts are thus assembled, capture housing  70  is bonded to base  62  by any suitable means such as adhesive or sonic bonding. This done, cover  66  is mated with capture housing  70  in the manner shown in  FIG. 3  and bonded in place.  
         [0134]     Upon opening the fluid delivery path, in a manner presently to be described, distendable membrane  64  will tend to return to its starting configuration thereby controllably urging fluid flow outwardly of the reservoir  75 . The fluid will then flow, via the flow control means of the invention, into the dispensing means of the invention, which comprises the earlier identified conventional administration set  163  ( FIG. 2 ). Administration set  163  is connected to housing  122  by a connector  211  in the manner shown in  FIG. 2  of the drawings. The proximal end  213   a  of administration line  213  of the administration set is in communication with outlet  136  which is formed in housing  122  in the manner best seen in  FIGS. 2 and 4 . Disposed between the proximal end  213   a  and the distal end  213   b  of the administration line  213  is a conventional Y-site  215 , a conventional gas vent and filter  217  and a conventional line clamp  219 . Provided at the distal end  213   b  is a luer connector  221  of conventional construction ( FIG. 2 ).  
         [0135]     Turning now to a consideration of the important cover means of this latest form of the invention, this means here comprises a housing assembly  224  which is interconnected with the reservoir subassembly  52  and functions to close the forward or delivery end of the device (see  FIGS. 1, 2  and  3 ). As best seen in  FIGS. 3 and 4 , housing assembly  224  includes the previously identified flow rate control housing  122  which defines a first compartment  226  that houses the flow rate control plate  80  and cover  82  and a second compartment  228  that houses the selection means, including the control knob and locking means of the invention. A third compartment  230  is defined by a cover component  232  that is pivotally movable from the closed position shown in  FIG. 1  to the open position shown in  FIG. 2 . Compartment  230  functions to house the dispensing means, or administration set  163  of the invention, when the administration set is not in use. As best seen in  FIG. 5 , rear face  235  of housing assembly  225  has a centrally disposed, socket-like recess  237  that closely receives a filter means shown here as a conventional particulate filter  239  and an inlet, or dispersion element,  240  when structure  225  is mated with reservoir subassembly  52  in the manner shown in  FIG. 3  of the drawings. Inlet element  240 , which functions as a fluid dispersion element, includes an inlet  242 , which communicates with the outlet  75   b  of fluid reservoir  75  via a flow passageway  75   c  ( FIG. 3 ). Inlet  242  also communicates with a circuitous fluid passageway  244 , which has an outlet  244   a  (see  FIGS. 4 and 13 ) that, in turn, communicates with inlet  82   h  to cover  82  of the flow rate control assembly (see  FIG. 16 ). Face  235  also has a rectangular opening  235   a  which receives the rate control plate  84  of the flow control subassembly  54  (see  FIG. 4 ).  
         [0136]     Referring next to  FIGS. 43, 44  and  45 , an alternate form of the fill means of the invention is there shown and generally designated by the numeral  250 . This alternate form of fill means is similar in many respects to that shown in  FIGS. 40, 41  and  42  and like numerals are used to identify like components. As shown in  FIG. 44  this alternate form of fill means comprises a syringe-type fill component  252  which includes a hollow housing  254  that is provided with a chamber  256  ( FIG. 44 ) for telescopically receiving a medicament containing cartridge fill vial container  258  the construction of which is illustrated in  FIG. 44 .  
         [0137]     As shown in  FIG. 44 , cartridge fill vial  258  comprises a hollow glass or plastic body portion  260  that defines a fluid chamber  262 . Fill vial  258  has an open first end  258   a  and a second end  258   b  that is closed by a pierceable, elastomeric septum  263 . An elastomeric plunger  264  is reciprocally movable within fluid chamber  262 . As shown in  FIG. 44 , a hollow needle  266  is mounted within the connector portion  268  of the hollow housing  254 . Hollow needle  266  is adapted to pierce septum  263  when the fill vial is inserted into a chamber  256  and pushed into the position shown in  FIG. 45  by the pusher means, or pusher assembly  270 . With this construction, as the fluid contained within the fluid chamber  262  is urged outwardly thereof by pusher  270   a  (See  FIG. 43 ) of the pusher assembly  270  fluid will controllably flow into hollow needle  266 .  
         [0138]     Turning to  FIG. 46 , it can be seen that when the fill means  250  is mated with the fluid dispenser, needle  266  pierces septum  79  which permits the fluid contained within the fluid chamber  262  to flow into cavity  79 , past umbrella type check valve  204  and into reservoir  75  via inlet  75   a.    
         [0139]     A number of beneficial agents can be contained within vial  258  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 prevention of diseases or the maintenance of the good health of the patient.  
         [0140]     In operation of the apparatus of the invention to deliver medicinal fluids to the patient at a controlled rate, following the opening of the fluid delivery path, distendable membrane  64  will tend to return to its starting configuration thereby controllably urging fluid flow outwardly of the reservoir  75 . The fluid will flow from the reservoir, through reservoir outlet port  75   b,  into inlet  242  of dispersion element  240 , through circuitous fluid passageway  244 , through particulate filter  239 , through outlet  244   a  and into inlet  326  of the control subassembly  54  (see  FIG. 47 ). From inlet  326  the fluid will flow via filter means, here provided as a filter “F” (see  FIGS. 49 and 58 ) into each of the micro-channels of the rate control plate  80 .  
         [0141]     When the selector knob  126  is in the priming position the fluid will flow from micro-channel  96  into radial passageway  120   g  of selector member  120 , into axial passageway  128 , then into an annular passageway  134 , which is in communication therewith and toward outlet port  136  formed on protuberance  122   a  (see  FIG. 7 ). During this process any gases contained within the fluid passageways will be vented to atmosphere via the vent means “V” ( FIG. 14 ).  
         [0142]     Delivery of fluid to the patient at different selected rates can be accomplished in a similar manner through rotation of knob  126  and selector member  302  to align other radial passageways of the selector member with selected outlets of the micro-channels of the rate control plate  80 .  
         [0143]     Referring next to  FIGS. 47 through 58 , a portion of an alternate form of the apparatus of the invention is there shown. This alternate form of the apparatus is similar in many respects to that shown in  FIGS. 1 through 46  and like numerals are used in  FIGS. 47 through 59  to identify like components. A primary difference between this latest form of the invention and that earlier described herein resides in the provision of flow rate control means which uniquely includes priming means for priming the various fluid passageways of the device prior to delivery of fluid to the administration set.  
         [0144]     As best seen in  FIG. 47 , the apparatus of this latest form of the invention comprises four major cooperating subassemblies namely, a reservoir subassembly  52  for containing the fluid to be dispensed to the patient, a flow control means for controlling the flow of fluid from the reservoir subassembly to the patient, a fluid dispensing subassembly  56  for dispensing the fluid to the patient and a fill assembly, similar to fill assembly  250  ( FIG. 46 ), for controllably filling the reservoir with the fluid to be dispensed to the patient.  
         [0145]     The reservoir subassembly  52 , the fluid dispensing subassembly  56  and the fill assembly  250  are substantially identical in construction and operation to those previously described herein and the details of their construction will not be further described. However, as previously discussed, the important flow control means of the invention for controlling the rate of fluid flow toward the fluid dispensing subassembly  56  is somewhat different from that previously described in that it uniquely comprises a priming means for purging and priming the various passageways of the device prior to delivery of fluid from the fluid reservoir to the fluid dispensing subassembly  56 . More particularly, this important priming means first purges to atmosphere any gases contained within the fluid passageways of the device and then controllably fills the fluid passageways with fluids drawn from the device reservoir. This feature of the apparatus ensures that only the desired fluid is delivered at the outlet passageway of the device during normal operation and that the device is in a state in which it will deliver fluid to the outlet passageway in as short a time as possible.  
         [0146]     The novel flow control means of this latest form of the invention comprises a selector means, which includes a selector member  302  having a plurality of fluid passageways formed therein ( FIG. 51 ) and a flow rate control assembly  304  ( FIG. 56 ) for controlling the rate of fluid flow toward the fluid dispensing subassembly  56 . Flow rate control assembly  304  includes a rate control plate, or member  306 , and an interconnected rate control cover  308  ( FIGS. 55 and 56 ). As best seen in  FIGS. 47 and 58 , rate control plate  306  is uniquely provided with a plurality of fluidic micro-channels identified in the drawings as  310 ,  312 ,  314 ,  316 ,  318 ,  320  and  322 . Each of the fluidic micro-channels is in communication with an inlet  326  via a priming passageway  328 , which comprises a part of the priming means of the invention, and each is provided with an outlet  328 ,  330 ,  332 ,  334 ,  336 ,  338 ,  340  and  342  respectively. These outlets align with cover outlet ports  344 ,  346 ,  348 ,  350 ,  352 ,  354 ,  356  and  358  respectively (see  FIGS. 55, 56  and  58 ) when the flow rate control assembly is assembled together in the manner illustrated in  FIG. 56 . Similarly, cover inlet port  360  aligns with rate control plate inlet  326  in the manner depicted in the drawings. As in the earlier described embodiment of the invention, each of the outlet ports formed in cover  308  can be placed in selective communication with the fluid dispensing means of the apparatus by controlled rotation of the selector member  302  of the rate control means of the invention the details of construction of which will presently be described.  
         [0147]     It is to be understood that, as before, the micro-channels formed in rate control plate  306  may be of different sizes, cross-sectional areas, lengths and configurations as shown by  FIG. 58 . Further, the flow control micro-channels may be rectangular in cross-section, 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.  
         [0148]     As indicated in  FIG. 48 , the flow rate control housing  364  of the flow control means is provided with an upraised portion  364   a  that defines an elongated, generally cylindrically-shaped chamber  366 . Receivable within chamber  366  is the second portion of the flow control means of the invention, namely the selector means, which comprises the previously identified selector member  302 . As before, sealing means in the form of an elastomeric sleeve  302   s  circumscribes member  302  and functions to seal member  302  relative to chamber  366 .  
         [0149]     Referring to  FIG. 47 , it can be seen that the important selector means of this latest embodiment of the invention also includes a cooperating control knob  126  which is used to controllably rotate selector member  302 . As indicated in  FIGS. 51, 52 ,  53  and  54 , selector member  302  is provided with an axially-extending fluid flow passageway  368  and a plurality of radially-extending passageways  368   a,    368   b,    368   c,    368   d,    368   e,    368   f,    368   g  and  368   h  that communicate with passageway  368 . In a manner presently to be described, rotation of selector member  302  within chamber  366  as a result of rotation of control knob  126  will permit a selected one of the plurality of radially-extending passageways formed in selector member  302  to be aligned with a selected one of the outlet ports of cover  308  and also with a selected one of the outlets of the fluidic micro-channels formed in rate control plate  306 . As indicated in  FIGS. 51 and 54 , selector member  302  is provided with an outlet passageway  370 , which communicates with axially-extending passageway  368  and also with a circumferentially-extending passageway  372 . Circumferentially-extending passageway  372  communicates with an outlet port  374  formed on protuberance  364   a  (see  FIG. 50 ), which, in turn, communicates with the fluid delivery line  138  of the fluid dispensing means ( FIGS. 2, 7  and  15 ).  
         [0150]     As shown in  FIG. 51 , the proximal end  302   a  of selector member  302  is beveled and is provided with a plurality of circumferentially-spaced driven teeth  140 . Teeth  140  mesh with a plurality of circumferentially-spaced driving teeth  142  formed on the inner beveled surface of a flange  144  of control knob  126  (see also  FIGS. 26 and 27 ). With this construction, when the shank portion  145  of control knob  302  is mated with flow control cover in the manner shown in  FIG. 47 , rotation of the control knob will impart rotation to the selector member  302 . As previously mentioned, controlled rotation of selector member  302  will cause one of the radially-extending passageways formed within the selector member to be moved into fluid communication with a selected one of the outlets of the rate control channels formed in the rate control plate  306 .  
         [0151]     Another important feature of the invention resides in the provision of locking means for locking the selector knob in position after a particular fluid flow micro-channel has been selected through rotation of the selector knob. The locking means of this latest form of the invention is identical in construction and operation to that previously described.  
         [0152]     Similarly, the fill assembly of this latest form of the invention for controllably filling the reservoir with the fluid to be dispensed to the patient is identical in construction and operation to that described in connection with the embodiment of the invention shown in  FIGS. 1 through 46 .  
         [0153]     Upon opening the fluid delivery path of this latest form of the invention, distendable membrane  64  ( FIG. 3 ) will tend to return to its starting configuration thereby controllably urging fluid flow outwardly of the reservoir  75  ( FIG. 3 ). The fluid will then flow through reservoir outlet port  75   b,  into the inlet of dispersion element  240 , through circuitous fluid passageway  244 , through particulate filter  239 , through outlet  244   a  and into inlet  326  of the flow rate control assembly (see  FIG. 47 ). From inlet  326  the fluid will flow into priming channel  328  via the filter “F” as well as into each of the micro-channels of the rate control plate  306 .  
         [0154]     When the selector knob  126  is in the priming position shown in  FIG. 47 , the fluid will flow from a priming channel  328  into radial passageway  368   h  of selector member  302 , into axial passageway  368  and toward outlet  374  thus priming these passageways with fluid and to purge any gases contained therein to atmosphere via the vent means “V” ( FIG. 50 ).  
         [0155]     By way of example, when the selector knob  126  is rotated to a position wherein radial passageway  368   g  of selector member  302  is aligned with the outlet  340  of micro-channel  322  of the rate control plate  306 , fluid will flow from micro-channel  322  into passageway  368 , then into annular passageway  372  which is in communication therewith and then into outlet  374  at a precisely controlled rate ( FIGS. 47, 51  and  58 ). Delivery of fluid to the patient at different selected rates can be accomplished in a similar manner through rotation of knob  126  and selector member  302  to align other radial passageways of the selector member with selected outlets of the micro-channels of the rate control plate  306 .  
         [0156]     It is important to note that priming of the various fluid passageways of the device ensures that only the desired fluid is delivered at the output of the device during normal operation and that the device is in a state in which it will deliver fluid at the exit of the administration line in a reasonably short a time. The value of the priming means of this latest form of the invention is evident from a study of  FIG. 72  of the drawings which comprises a table of the fluidic properties of one form of the flow rate control member, or chip  306 , the flow rate selector means and the administration line of the device of this latest form of the invention. For purposes of illustration in  FIG. 72 , the flow rates are shown to be between 0.1 and 50 ml/hr and the rate defining channels are assumed to be from 4000 μm 2  to 40,000 μm 2 . Similarly, the priming channel is assumed to be 1000 μm×100 μm wide×deep, the channel in the rate control selector means is assumed to be 1 mm in diameter and 3 cm long and the administration line is assumed to be 1 meter long and 40 thousandths of an inch (approx. 1 mm) in diameter. The priming channels on the chip, the channel in the flow rate selector means and the administration line are treated as one item for the purpose of priming time and flow rate.  
         [0157]     If the fluidic system is not compatible with the fluid being transported, either in terms of its biocompatibility or hyrdophilicity characteristics, a surface modification process will be needed. While not wanting to be held to a particular approach, the surface modification methodology may take one of several forms. One process that is extremely clean, fast and effective is plasma processing. In particular this technique allows for any of the following 1) plasma activation, 2) plasma induced grafting and 3) plasma polymerization of molecular entities on the surface of the bellows. For cases where an inert hydrophobic interface is desired, plasmas using hydrophilic molecules may be employed. That is, the channels&#39; surface may be cleaned with an inert gas plasma, and subsequently, an appropriate plasma may be used to graft these molecule to the surface. Alternatively, if a hydrophobic surface is desired (e.g. for solutions that are highly corrosive or in oil-based solvents) an initial plasma cleaning may be done, followed by a plasma polymerization using hydrophobic monomers.  
         [0158]     From a study of  FIG. 72  it can be seen that if one of the flow rate defining fluidic micro-channels were used to prime the administration line, then there would be an unreasonably long time between the time that the device is initially “turned on” and the time that fluid is delivered from the administration line. This is because the volume of the administration line is 0.785 ml. For example, suppose the flow rate is 0.5 ml/hr then it would be 94 minutes (i.e., 0.785 ml/0.5 ml/hr=1.57 hours) before fluid emerges from the administration line and the device is ready to use. This length of time to wait before the device is ready to use is undesirable in most applications of the device. It is evident that a priming means envisioned by this latest form of the device of the invention is an advantageous feature which enables the device be ready to administer fluid in a matter of a minute or less.  
         [0159]     Turning next to  FIGS. 60 through 71 , an alternate form of flow rate control assembly is there illustrated and generally designated by the numeral  440 . Flow rate control assembly  440  is usable with the apparatus shown in  FIGS. 4 and 7  of the drawings and is adapted to be disposed within chamber  226  of the device housing. This alternate form of the flow rate control assembly is also adapted to cooperate with the selector means of the apparatus of  FIG. 4  in a manner previously described to select the desired rate of fluid flow from the fluid source toward the fluid delivery line.  
         [0160]     The primary difference between this latest flow rate control assembly and that previously described is that the fluidic micro flow channels which control the rate of fluid flow are formed in the lower surface  440   a  of the rate control cover  242  of the assembly (see  FIG. 65 ). More particularly, lower surface  442   a  of cover  442  is provided with a plurality of micro channels identified as  444 ,  446 ,  448 ,  450 ,  452 ,  454 , and  456 . When the rate control base  460  of a rate control assembly is sealably interconnected with cover  442  in the manner shown in  FIG. 59  the plurality of micro channels will be sealed to form a plurality of fluidic micro channels. In this regard, it is to be noted that a circumferentially-extending channel  442   b  is formed in cover  442  ( FIG. 62 ). It is also to be observed that cover  442  is provided with a circumferentially extending, sonic energy director  442   c  ( FIG. 66 ), which enables the cover member to be sonically bonded to the apparatus housing  122  when the alternate form of rate control assembly is positioned within chamber  226 . Sealably receivable within channel  442   b  is an upstanding, circumferentially extending step  460   a  formed on base member  460  ( FIGS. 70 and 71 ).  
         [0161]     Each of the fluidic micro channels is in communication with the rate control inlet  462  via the priming means of the invention for purging and priming the various fluid delivery passageways of the flow control means. This priming means here comprises a prime channel  463  which functions to purge gases from delivery line  213  and to prime the various fluidic elements of the device before the fluid is delivered to the fluid delivery line  213 . It is to be noted that the fluidic micro channels are provided with inlets  444   a,    446   a,    448   a,    450   a,    452   a,    454   a,  and  456   a  respectfully ( FIG. 65 ). These inlets are in communication with prime channel  463  so that as the prime channel is filled, each of the fluidic micro channels will also fill. Prime channel  463  is also in communication with a prime channel outlet port  464 , which, in turn, communicates with cover outlet port  464   a  ( FIG. 65 ) formed in cover member  442 . Cover member outlet port  264   a  aligns with an inlet to the flow rate control assembly, the details of construction of which were described in connection with a description of the previously embodiment of the invention. As the various fluid flow passageways of the device fill with fluid during the priming step, gases contained within the passageways will be vented to atmosphere via a vent “V” formed in member  464   a  ( FIG. 50 ). Additionally, venting can be provided by vent means formed on the fluidic chip or plate  460  in the form of a vent VP ( FIG. 65 ) and on the cover  442  in the form of a vent VC ( FIG. 63 ).  
         [0162]     The fluidic micro channels are also provided with outlets  444   b,    446   b,    448   b,    450   b,    452   b,    454   b,    456   b  and  458   b  respectfully ( FIG. 65 ). These outlets align with cover outlet ports  466 ,  468 ,  470 ,  472 ,  474 ,  476 , and  478  respectively ( FIG. 63 ). Each of the cover outlet ports comprises a compressible elastomeric sleeve which sealably engages the wall  226   a  of chamber  226  which receives the rate control assemblage  440  when the components are assembled in the manner shown in  FIG. 68A . As the components are assembled, the sleeves are compressed to provide a fluid seal, or sealing means, that prevents fluid leakage about the ports.  
         [0163]     As previously discussed in connection with the earlier described embodiment of the invention, each of the outlet ports formed in the rate control cover can be placed in selective communication with the fluid delivery line  213  by manipulation of the rate control means of the invention. In this way, the rate of fluid flow toward the fluid delivery line can be can be precisely controlled by the caregiver.  
         [0164]     As earlier described herein, the fluidic micro channels formed in cover  142  of this latest form of the invention may be of different sizes, lengths and configurations as shown in  FIG. 65 . Further, the flow control fluidic micro channels may be rectangular in cross-section, or alternatively, can be semicircular in cross-section, U-shaped in cross-section, or they may have any other cross-sectional and surface configuration that may be appropriate to achieve the fluid flow characteristics that are desired in the particular end use application.  
         [0165]     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.