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

Full Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This is a divisional application of co-pending application U.S. Ser. No. 10/855,446 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 includes a novel bellows reservoir and a unique adjustable flow rate control means for precisely adjustably controlling the rate of fluid flow from the bellows reservoir of the device toward the patient. 
         [0006]    2. Description of Related Art Including Information Disclosed Under 37 CFR 1.97 and 1.98 
         [0007]    Many medicinal agents require an intravenous route for administration of the medicament. The delivery device for delivering the medicament, 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. 
         [0008]    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. 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. 
         [0009]    One of the most versatile and unique fluid delivery apparatus developed in recent years is that developed by one of the present inventors and described in U.S. Pat. No. 5,205,820. The components of this novel fluid delivery apparatus generally includes: 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. 
         [0010]    Another prior art patent issued to one of the present applicants, namely U.S. Pat. No. 5,743,879, discloses an injectable medicament dispenser for use in controllably dispensing fluid medicaments such as insulin, anti-infectives, analgesics, oncolylotics, cardiac drugs biopharmaceuticals, and the like from a prefilled container at a uniform rate. The dispenser, which is quite dissimilar in construction and operation from that of the present invention, includes a stored energy source in the form of a compressively deformable, polymeric elastomeric member that provides the force necessary to controllably discharge the medicament from a prefilled container, which is housed within the body of the device. After having been deformed, the polymeric, elastomeric member will return to its starting configuration in a highly predictable manner. 
         [0011]    Another important prior art fluid delivery device is described in the U.S. Pat. No. 6,063,059 also issued to one of the present inventors. 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. 
         [0012]    As will be appreciated from the discussion, which follows, the apparatus of the present invention is uniquely suited to provide precise, continuous fluid delivery management at a low cost in those cases where a variety of precise dosage schemes are of utmost importance. An important aspect of the apparatus of the present invention is the provision a novel, rotatable fluid flow rate control means that includes uniquely formed micro capillary, multichannel flow rate control channels which enable precise control of the rate of fluid flow of the medicament to the patient. More particularly, the apparatus of the present invention includes a novel, adjustable fluid flow rate mechanism which enables the fluid contained within the reservoir of the device to be precisely dispensed at various selected rates. 
         [0013]    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 antibiotics, such as, for example, an antibiotic sold by Abbott Laboratories under the name and style ANCIF and by Rosche under the name and style ROCEPHIN, analgesics, such as morphine and like medicinal agents. 
         [0014]    By way of summary, the apparatus of the present invention uniquely overcomes the drawbacks of the prior art by providing a novel, disposable dispenser of simple but highly reliable construction. A particularly important aspect of the apparatus of the present invention resides in the provision of a novel, self-contained energy source in the form of a compressible-expandable spring member that provides the force necessary to substantially, uniformly dispense various solutions from the device reservoir. 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. 
       BRIEF SUMMARY OF THE INVENTION 
       [0015]    It is an object of the present invention to provide a compact fluid dispenser for use in controllably dispensing fluid medicaments, such as, antibiotics, analgesics, and like medicinal agents from the novel bellows-type device reservoir. 
         [0016]    It is another object of the invention to provide a fluid dispenser of the aforementioned character, which is highly reliable and is easy-to-use by laypersons in a non-hospital environment. 
         [0017]    Another object of the invention is to provide a small, compact fluid dispenser that includes novel fill means for filling the bellows type dispenser reservoir with the medicament to be dispensed. 
         [0018]    Another object of the invention is to provide an apparatus which can be factory pre-filled with a wide variety of medicinal fluids or one which can readily be filled in the field shortly prior to use. 
         [0019]    Another object of the invention is to provide a dispenser in which a stored energy source is provided in the form of a constant force spring member of novel design that provides the force necessary to continuously and substantially uniformly expel fluid from the device reservoir. 
         [0020]    Another object of the invention is to provide a device of the aforementioned character which includes novel adjustable flow rate control means disposed intermediate the fluid reservoir outlet and the outlet port of the device for precisely controlling the rate of fluid flow from the outlet port toward the patient. 
         [0021]    Another object of the invention is to provide a dispenser that includes precise variable flow rate selection. 
         [0022]    Another object of the invention is to provide a fluid dispenser of the class described which is compact, lightweight, is easy for ambulatory patients to use, is fully disposable, and is extremely accurate so as to enable the infusion of precise doses of medicament over prescribed periods of time. 
         [0023]    Another object of the invention is to provide a device of the character described which embodies a novel fluid volume indicator that provides a readily discernible visual indication of the volume of fluid remaining in the device reservoir. 
         [0024]    Another object of the invention is to provide a self-contained medicament dispenser which is of very simple construction and yet extremely reliable in use. 
         [0025]    Another object of the invention is to provide a fluid dispenser as described in the preceding paragraphs, which is easy and inexpensive to manufacture in large quantities. 
     
    
     
       BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS 
         [0026]      FIG. 1  is a generally perspective view of one form of the fluid dispensing device of the present invention showing one side of the device. 
           [0027]      FIG. 2  is a generally perspective view of the fluid dispensing device shown in  FIG. 1  showing the opposite side of the device. 
           [0028]      FIG. 3  is a rear view of the fluid-dispensing device shown in  FIGS. 1 and 2 . 
           [0029]      FIG. 4  is a front view of the fluid-dispensing device shown in  FIGS. 1 and 2 . 
           [0030]      FIG. 5  is a side view of one of the locking arms of the device. 
           [0031]      FIG. 6  is a cross-sectional view taken along lines  6 - 6  of  FIG. 4 . 
           [0032]      FIG. 7  is a cross-sectional view taken along lines  7 - 7  of  FIG. 4 . 
           [0033]      FIG. 8  is a cross-sectional view taken along lines  8 - 8  of  FIG. 7 . 
           [0034]      FIG. 9  is a cross-sectional view taken along lines  9 - 9  of  FIG. 7 . 
           [0035]      FIG. 10  is a cross-sectional view taken along lines  10 - 10  of  FIG. 7 . 
           [0036]      FIG. 11  is a cross-sectional view taken along lines  11 - 11  of  FIG. 7 . 
           [0037]      FIG. 12  is a generally perspective, exploded view of the rear portion of the fluid dispensing device shown in  FIG. 1 . 
           [0038]      FIG. 13  is a generally perspective exploded view of the fluid dispensing device shown in  FIG. 1 . 
           [0039]      FIG. 14  is a generally perspective view of the micro rate selector knob assembly of the device. 
           [0040]      FIG. 15  is a fragmentary cross-sectional view of a portion of the flow rate control means of the invention showing the micro rate selector knob assembly in an off condition. 
           [0041]      FIG. 16  is a fragmentary cross-sectional view of a portion of the flow rate control means of the invention showing the micro rate selector knob assembly in a delivery condition. 
           [0042]      FIG. 17  is a generally perspective view of the macro rate selector knob assembly of the fluid dispensing device. 
           [0043]      FIG. 18  is a side elevational view of the outer face of the cover member of the rate control assembly of the invention. 
           [0044]      FIG. 18A  is an enlarged cross-sectional view taken along lines  18 A- 18 A of  FIG. 18 . 
           [0045]      FIG. 18B  is an enlarged cross-sectional view taken along lines  18 B- 18 B of  FIG. 18 . 
           [0046]      FIG. 19  is an enlarged cross sectional view taken along lines  19 - 19  of  FIG. 18 . 
           [0047]      FIG. 20  is an enlarged cross sectional view taken along lines  20 - 20  of  FIG. 18 . 
           [0048]      FIG. 21  is an end view of the flow rate control assembly of this latest form of the fluid delivery device of the invention. 
           [0049]      FIG. 22  is a view taken along lines  22 - 22  of  FIG. 21 . 
           [0050]      FIG. 23  is an end view of the inner face of the base member of the rate control assembly of this latest form of the invention. 
           [0051]      FIG. 24  is an enlarged, fragmentary view of the portion identified in  FIG. 23  as “ 24 ”. 
           [0052]      FIG. 25  is a generally perspective illustrative view of a portion of the fluid delivery device of the invention showing the fluid flow path during the fill step. 
           [0053]      FIG. 26  is a generally perspective illustrative view of a portion of the fluid delivery device of the invention showing the fluid flow path during the fluid delivery step. 
           [0054]      FIG. 27  is a longitudinal cross-sectional view of an alternate form of the fluid dispensing device of the present invention. 
           [0055]      FIG. 28  is a rear view of the fluid-dispensing device shown in  FIG. 27 . 
           [0056]      FIG. 29  is a front view of the fluid-dispensing device shown in  FIG. 27 . 
           [0057]      FIG. 30  is a cross-sectional view taken along lines  30 - 30  of  FIG. 27 . 
           [0058]      FIG. 31  is a side view of one of the locking arms of the device. 
           [0059]      FIG. 32  is a cross-sectional view taken along lines  32 - 32  of  FIG. 29 . 
           [0060]      FIG. 33  is a cross-sectional view taken along lines  33 - 33  of  FIG. 27 . 
           [0061]      FIG. 34  is a cross-sectional view taken along lines  34 - 34  of  FIG. 27 . 
           [0062]      FIG. 35  is a cross-sectional view taken along lines  35 - 35  of  FIG. 27 . 
           [0063]      FIG. 36  is a generally perspective, exploded view of the fluid dispensing device shown in  FIG. 27 . 
           [0064]      FIG. 37  is a longitudinal cross-sectional view of still another form of the fluid dispensing device of the present invention. 
           [0065]      FIG. 38  is a rear view of the fluid-dispensing device shown in  FIG. 37 . 
           [0066]      FIG. 39  is a front view of the fluid-dispensing device shown in  FIG. 37 . 
           [0067]      FIG. 40  is a cross-sectional view taken along lines  40 - 40  of  FIG. 37 . 
           [0068]      FIG. 41  is a side view of one of the locking arms of the device. 
           [0069]      FIG. 42  is a cross-sectional view taken along lines  42 - 42  of  FIG. 39 . 
           [0070]      FIG. 43  is a cross-sectional view taken along lines  43 - 43  of  FIG. 37 . 
           [0071]      FIG. 44  is a cross-sectional view taken along lines  44 - 44  of  FIG. 37 . 
           [0072]      FIG. 45  is a cross-sectional view taken along lines  45 - 45  of  FIG. 37 . 
           [0073]      FIG. 46  is a generally perspective, exploded view of the fluid dispensing device shown in  FIG. 37 . 
           [0074]      FIG. 47  is a longitudinal cross-sectional view of yet another form of the fluid dispensing device of the present invention. 
           [0075]      FIG. 47A  is a longitudinal cross-sectional view of a specially designed vial cartridge that enables the intermixing of a lyophilized drug with a suitable diluent prior to the delivery of the mixture of the fluid reservoir of the device. 
           [0076]      FIG. 48  is a rear view of the fluid-dispensing device shown in  FIG. 47 . 
           [0077]      FIG. 49  is a front view of the fluid-dispensing device shown in  FIG. 47 . 
           [0078]      FIG. 50  is a cross-sectional view taken along lines  50 - 50  of  FIG. 47 . 
           [0079]      FIG. 51  is a side view of one of the locking arms of the device. 
           [0080]      FIG. 52  is a cross-sectional view taken along lines  52 - 52  of  FIG. 49 . 
           [0081]      FIG. 53  is a cross-sectional view taken along lines  53 - 53  of  FIG. 47 . 
           [0082]      FIG. 54  is a cross-sectional view taken along lines  54 - 54  of  FIG. 47 . 
           [0083]      FIG. 55  is a cross-sectional view taken along lines  55 - 55  of  FIG. 47 . 
           [0084]      FIG. 56  is a generally perspective, exploded view of the fluid dispensing device shown in  FIG. 47 . 
           [0085]      FIG. 57  is a longitudinal cross-sectional view of still another embodiment of the fluid dispensing device of the present invention. 
           [0086]      FIG. 58  is a rear view of the fluid-dispensing device shown in  FIG. 57 . 
           [0087]      FIG. 59  is a front view of the fluid-dispensing device shown in  FIG. 57 . 
           [0088]      FIG. 60  is a cross-sectional view taken along lines  60 - 60  of  FIG. 57 . 
           [0089]      FIG. 61  is a side view of one of the locking arms of the device. 
           [0090]      FIG. 62  is a cross-sectional view taken along lines  62 - 62  of  FIG. 59 . 
           [0091]      FIG. 63  is a cross-sectional view taken along lines  63 - 63  of  FIG. 57 . 
           [0092]      FIG. 64  is a cross-sectional view taken along lines  64 - 64  of  FIG. 57 . 
           [0093]      FIG. 65  is a cross-sectional view taken along lines  65 - 65  of  FIG. 57 . 
           [0094]      FIG. 66  is a generally perspective, exploded view of the fluid dispensing device shown in  FIG. 57 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0095]    Referring to the drawings and particularly to  FIGS. 1 through 26 , one form of the apparatus of the present form of the invention is there illustrated and generally designated by the numeral  102 . As best seen in  FIGS. 1 ,  2  and  13 , the apparatus here comprises a snap together outer housing  104  having first and second portions  104   a  and  104   b,  respectively. Housing portion  104   a  comprises the reservoir portion, while housing portion  104   b  comprises the rate control, fill and delivery and control portions. When snapped together the housing portions define a carrying handle  104   c.    
         [0096]    Disposed within first portion  104   a  of outer housing  104  is a novel expandable housing  105  having a fluid reservoir  105   a  ( FIGS. 7 and 13 ) provided with an inlet passageway  105   b  for permitting fluid flow into the fluid reservoir and an outlet  105   c  for permitting fluid flow from the fluid reservoir. Expandable housing  105 , which can be constructed from a metal or plastic material and can include a coating of the character presently to be described, comprises a bellows structure having an expandable and compressible, accordion-like, annular-shaped sidewall  105   d,  the configuration of which is best seen in  FIGS. 7 and 13 . A capture ring  105   e  ( FIGS. 7 and 13 ) secures the expandable housing in position. 
         [0097]    Disposed within second portion  104   a  of outer housing  104  is the novel stored energy means of the invention for acting upon inner expandable housing  105  in a manner to cause the fluid contained within fluid reservoir  105   a  to controllably flow outwardly of the housing, through the dispensing means of the invention and onwardly toward the patient. In the present form of the invention, this important stored energy means comprises a constant force spring member  107  that is carried within the second portion  104   a  of the outer housing. Spring member  107  is first extended by fluid flowing into reservoir  105   a  and then controllably retracts in the manner shown in  FIG. 7  to cause fluid flow from the outer housing through the dispensing means of the invention. Stored energy member or constant force spring  107 , which is a special variety of extension spring, is readily commercially available from several sources including Barnes Group Inc. of Bristol, Conn., Stock Drive Products/Sterling Instrument of Hyde Park, N.Y. and Walker Corporation of Ontario, Canada. Constant force extension spring  107  is basically a high stress, long deflection device that offers great advantages when used in applications where very low or zero gradient is desired, where space is a factor and where very high reliability is required. Constant force springs, such as spring  107 , provide markedly superior constant force loading when compared to conventional helical extension or like springs. Spring  107 , after being expanded, tends to uniformly return toward its starting configuration and in so doing will exert an inward pressure on a pusher means, shown here as pusher member  109  of the character shown in  FIG. 7 . Pusher member  109  is operably coupled with the expandable housing  105  and functions to move the expandable housing from an expanded configuration to a contracted configuration. More particularly, as the spring  107  returns toward its starting configuration, it will act on pusher member  109  in a manner to move the expandable housing from an expanded configuration to a contracted configuration and in so doing will cause the fluid contained within the fluid reservoir  105   a  to flow outwardly through outlet  105   c  and toward the flow rate control means of the invention at a substantially constant rate. 
         [0098]    Forming an important aspect of the apparatus is the fill means, which is carried by the first portion  104   a  of outer housing  104  and functions to controllably fill the reservoir  105   a  with the fluid to be dispensed. As best seen in  FIG. 7 , housing portion  104   b  includes a fluid passageway  110  that communicates with inlet  105   b  of fluid reservoir  105   a.  Fluid passageway  110  also communicates with a cavity  114  formed within first portion  104   b  of the housing. Disposed within cavity  114  is a conventional, umbrella type check valve  116 , which permits fluid flow toward fill passageway  110 , but blocks fluid flow in the opposite direction. Passageway  110  also communicates, via a passageway  118 , with a cavity  120  that houses a pierceable septum  122 , which comprises a part of one form of the fill means of the invention. Septum  122  may be a conventional slit septum, the character well understood by those skilled in the art, which is pierceable by the cannula of a filling syringe assembly (not shown) which contains the medicinal fluid to be dispensed and which, in a manner presently to be described, can be used to fill or partially fill reservoir  105   a  via passageway  110 . 
         [0099]    First portion  104   a  of housing  104  includes a vial receiving portion  124  that is normally closed by a closure cap  126 . Connector portion  124  is provided with a chamber  124   a  for telescopically receiving the medicament fill vial assembly of the invention the character of which will presently be described. An elongated support  128 , which is mounted within chamber  124   a  includes a threaded end portion  128   a  and carries an elongated, longitudinally extending, hollow needle  129  having a central fluid flow passageway. 
         [0100]    Referring particularly to  FIG. 12 , the medicament containing fill vial assembly  130  includes a fill vial  132  having a fluid chamber  134  for containing the injectable fluid medicament. Chamber  134  is provided with a first open end  134   a  and second closed end  134   b.  First open end  134   a  is sealably closed by closure means here provided in the form of an externally threaded elastomeric plunger  136  which is telescopically movable within chamber  134  from a first location where the plunger is disposed proximate first open end  134   a  to the second, device-fill location where the plunger is disposed proximate second closed end  134   b  ( FIG. 7 ). 
         [0101]    After removal of closure cap  126  from connector portion  124 , vial assembly  130  can be inserted into chamber  124   a  ( FIGS. 7 and 13 ). As the fill vial assembly is so introduced and the plunger  136  is threadably interconnected with threaded end  128   a  of support  128 , the sharp end  129   a  of the elongated needle  129  will pierce the central wall  136   a  of the elastomeric plunger in the manner shown in  FIG. 7 . An inward pressure exerted on the vial assembly will cause the vial to move inwardly of chamber  124   a  and will cause the structural support  128  to move the elastomeric plunger inwardly of the vial chamber  134  in a direction toward the second or closed end  134   b  of the vial chamber. As the plunger is moved inwardly of the vial, the fluid contained within the vial chamber will be expelled there from into the hollow elongated needle  129 , which has pierced the central wall  136   a  of the elastomeric plunger. The fluid will then flow past conventional umbrella type check valve  116 , into passageway  110  and thence into a passageway  140  which communicates with reservoir inlet  105   b.    
         [0102]    As the fluid flows into reservoir  105   a,  the bellows  105   d  will expand in a manner to exert a rearward pressure on the plunger end portion  109   a  of pusher member  109  causing it to move rearwardly. As the pusher member moves rearwardly, it will exert forces on spring member  107  causing it to expand from its retracted configuration shown in  FIG. 7  to its expanded configuration. This rearward movement of pusher member  109  can be viewed through the volume indicator window  142  indicating that the reservoir has changed from an empty configuration to a filled configuration ( FIG. 1 ). 
         [0103]    As the reservoir  105   a  fills with fluid, any gases trapped within the reservoir will be vented to atmosphere via vent means “V”, mounted in portion  104   b  of the housing. This vent means here comprises a gas vent  143  that can be constructed of a suitable hydrophobic porous material such as a porous plastic. 
         [0104]    Upon opening the fluid delivery path to the fluid delivery means of the invention, shown here as a conventional administration set  144  ( FIG. 1 ), the stored energy means, or spring  107 , will tend to return to its starting configuration thereby controllably urging fluid flow outwardly of reservoir  105   a  via the flow control means of the invention the character of which will presently be described. 
         [0105]    Administration set  144  is connected to the second portion  104   b  of housing  104  by a connector  146  in the manner shown in  FIG. 1  of the drawings. The proximal end  148   a  of administration line  148  of the administration set is in communication with an outlet fluid passageway  152  which is formed in housing portion  104   b  in the manner best seen in  FIG. 7 . Disposed between the proximal end  148   a  and the distal end of the administration line are a conventional gas vent and filter  154 . Provided at the distal end  148   b,  is a luer connector  156  of conventional construction ( FIG. 1 ). Between gas vent and filter  154  and luer connector  156  is a conventional line clamp  158  and disposed between gas vent and filter  144  and the proximal end  148   a  of the administration line is a conventional “Y” site  159 . 
         [0106]    A number of beneficial agents can be contained within vial  132  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. 
         [0107]    As the fluid contained within reservoir  105   a  is urged outwardly thereof by the stored energy means, the fluid will flow under pressure through reservoir outlet  105   c  ( FIG. 7 ) and then on toward the flow control means, or flow control assembly of this latest form of the invention. This important flow control means functions to precisely control the rate of fluid flow flowing from the reservoir  105   a  toward the patient. 
         [0108]    Referring to  FIGS. 18 through 26 , it can be seen that the flow rate control means of the flow control means of this latest form of the invention comprises an assembly which includes a base plate, or rate control member  160  and a mating cover member  162  ( FIG. 21 ). Cover member  162  is provided with a fluid inlet port  164  and a plurality of spaced apart, generally tubular shaped micro rate fluid outlet ports  166   a,    166   b,    166   c,    166   d  and  166   e  respectively. As illustrated in  FIG. 22 , flow rate control member, or base plate  160  is uniquely provided with a plurality of micro rate flow control channels  160   a,    160   b,    160   c,    160   d  and  160   e  respectively, each having an inlet and an outlet. As indicated in the drawings, the outlets of the micro rate flow control channels are in communication with the spaced apart micro rate outlet ports of the cover member  162  and the inlet port is in fluid communication with reservoir  105   a.  Cover member  162  is also provided with a plurality of spaced apart, generally tubular shaped macro rate fluid outlet ports  170   a,    170   b,    170   c,    170   d  and  170   e  respectively. Flow rate control member, or base plate  160  is also uniquely provided with a plurality of macro rate flow control channels  172   a,    172   b,    172   c,    172   d  and  172   e  respectively, each having an inlet and an outlet  173   a,    173   b,    173   c,    173   d  and  173   e.  The outlets of the macro rate flow control channels are in communication with the spaced apart macro rate outlet ports of the cover member  162 . 
         [0109]    As indicated in  FIG. 20 , inlet port  164  is provided with a filter member  175  of conventional construction for filtering particulates from the fluid flowing toward the various rate control channels. 
         [0110]    Also forming a part of the flow control means of this latest form of the invention is a micro rate selector knob  180  that is carried within a horizontal bore  182  formed in housing portion  104   b.  Selector knob  180  includes a body portion  180   a  and an enlarged diameter head portion  180   b.  As illustrated in  FIG. 14 , selector knob  180  is uniquely provided with a plurality of radially extending flow control channels  184   a,    184   b,    184   c,    184   d  and  184   e,  each having an inlet port and an outlet port which is in fluid communication with an axially extending passageway  186 . Axially extending passageway  186  is, in turn, in fluid communication with administration line  148 . In a manner presently to be described, micro selector knob, which comprises a part of the selector means of this latest form of the invention, functions to selectively align one of the inlets of the radially extending flow control channels of the selector knob with a selected one of the spaced apart micro rate fluid outlets  166   a,    166   b,    166   c,    166   d  and  166   e  of the rate control cover  162  ( FIG. 18 ). 
         [0111]    Also forming a part of the flow control means of this latest form of the invention is a macro rate selector knob  190  that is carried within a horizontal bore  192  formed in housing portion  104   b.  Selector knob  190  includes an enlarged diameter head portion  190   b  and a generally cylindrical body portion  190   a.  As illustrated in  FIG. 17 , selector knob  190  is uniquely provided with a plurality of radially extending flow control channels  194   a ,  194   b,    194   c,    194   d  and  194   e,  each having an inlet port and an outlet port which it is in fluid communication with an axially extending passageway  196 . Axially extending passageway  196  is, in turn, in fluid communication with administration line  148 . 
         [0112]    In a manner presently to be described, selector knob  190 , which also comprises a part of the selector means of this latest form of the invention, functions to selectively align one of the inlets of the radially extending flow control channels of the macro selector knob with a selected one of the spaced apart macro rate fluid outlets  170   a,    170   b,    170   c,    170   d  and  170   e  of the rate control cover  162  ( FIG. 18 ). 
         [0113]    As best seen in  FIGS. 7 and 25 , inlet port  164  of the rate control assembly is in communication with the outlet port  105   c  of reservoir  105   a  via a passageway  197  with which it is in communication. As the pusher assembly  109  is urged forwardly by the stored energy means, the fluid contained within reservoirs  105   a  will flow through the outlet port  105   c , through passageway  197  and into inlet  164  of the rate control assembly in a manner to permit each of the micro channels and each of the macro channels of the rate control plate  160  to fill with the medicinal fluid to be dispensed to the patient. 
         [0114]    In using the apparatus, rotation of the micro rate selector knob  180  will permit each of the spaced outlets of the micro channels to selectively be aligned with a selected one of the outlets  166   a,    166   b,    166   c,    166   d  and  166   e  of the rate control cover  162 . The fluid can then flow into a selected one of the plurality of passages  184   a,    184   b,    184   c,    184   d  and  184   e,  formed in the micro rate selector knob  180 , into axially extending passageway  186 , into the administration line  148  via a circumferentially extending fluid flow passageway  199  (see  FIGS. 7 and 26 ), into the administration line  148  and then on to the patient at a precise micro rate of flow. To assist in rotating knob  180 , the knob is provided with a finger gripping bar  181  ( FIG. 1 ). 
         [0115]    In operation, upon rotation of selector knob  180  a selected one of the micro channels outlets  166   a,    166   b,    166   c,    166   d  and  166   e  will align with a selected inlet  184   a,    184   b,    184   c,    184   d  and  184   e  of selector knob  180  (see  FIGS. 15 and 16 ). For example, when outlet  166   a  is in index with inlet  184   a  ( FIG. 16 ), fluid will flow from reservoir  105   a  through micro channel  160   a,  into selector knob inlet  184   a  via cylindrical outlet port  166   a,  into central passageway  186 , into annular passageway  199 , into passageway  152 , into the administration line  148  and toward that patient at a precise, predetermined first rate. Similarly, when outlet  166   c  of micro channel  160   c  is aligned with inlet  184   c  of selector  180 , fluid will flow from reservoir  105   a  through micro channel  160   c,  into selector inlet  184   c  via cylindrical outlet port  166   c,  into central passageway  186 , into annular passageway  199 , into passageway  152 , into the administration line  148  and toward the patient at a second rate. 
         [0116]    As shown in  FIG. 14 , selector knob  180  is provided with a plurality of circumferentially spaced apart indexing cavities  200  that closely receive the end of an indexing finger  202   a  of an outwardly extending locking arm  202 , which forms a part of the flow control means of the invention and functions to prevent rotation selector knob  180 . ( FIGS. 6 ,  13  and  10 ) Finger  202   a  is continuously urged into a selected one of the indexing cavities  200  formed in knob  180  by a coiled spring  204  ( FIGS. 6 and 13 ). In order to permit rotation of knob  180 , arm  202  must be pushed inwardly against the urging of spring  204 . 
         [0117]    In a similar manner, rotation of the macro rate selector knob  190  will permit each of the spaced outlets of the macro channels to selectively be aligned with a selected one of the outlets  170   a,    170   b,    170   c,    170   d  and  170   e  of the rate control cover  162 . The fluid can then flow into a selected one of the plurality of passages  194   a,    194   b,    194   c,    194   d  and  194   e  formed in the micro rate selector knob  190 , into axially extending passageway  196 , into the administration line via a circumferentially extending fluid flow passageway  205 , via a passageway  205   a  formed in housing portion  104   b  (see  FIGS. 7 and 17 ) and then on to the patient at a precise macro rate of flow. To assist in rotating knob  190 , the knob is provided with a finger gripping bar  191  ( FIG. 1 ). 
         [0118]    As shown in  FIG. 17 , selector knob  190  is provided with a plurality of circumferentially spaced apart indexing cavities  206  that closely receive the end of an indexing finger  208   a  of an outwardly extending locking arm  208 , which forms a part of the flow control means of the invention and functions to prevent rotation selector knob  190  ( FIGS. 6 and 13 ). Finger  208   a  is continuously urged into a selected one of the indexing cavities  206  formed in knob  190  by a coiled spring  210  ( FIGS. 6 and 13 ). In order to permit rotation of knob  190 , arm  208  must be pushed inwardly against the urging of spring  210 . 
         [0119]    The apparatus of this latest form of the invention also includes disabling means for irrevocably disabling the device and rendering it inert. Referring to  FIGS. 1 ,  4  and  11 , this disabling means here comprises a disabling shaft  214  that is telescopically movable within a passageway  216  formed within housing portion  104   b.  As best seen in  FIG. 11 , shaft  214  has a distal end  214   a,  which, upon insertion of the shaft distal end into passageway  152 , will block fluid flow through the passageway. A friction fit retainer  216  normally holds shaft  214  in the retracted position. 
         [0120]    The details of the construction of the important rate control plate, or member  160  of the invention 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 and epoxies. In other variations, the materials used for the flow control plate may be made of glass or silica. In further variations, the flow control component may be made of metals or inorganic oxides. 
         [0121]    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 and casting. 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. 
         [0122]    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 □m. Subsequently, electroforming is preformed to produce the negative metal form, or mold insert. Alternatively for larger channel systems, precision milling can be used to make the mold insert directly. Typical materials for the mold insert or embossing tool are nickel, nickel alloys, steel and brass. Once the mold insert of embossing tool is fabricated, the polymer of choice may be injection molded or embossed to yield the desired part with imprinted channels. 
         [0123]    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, example MicroTEC, mbH of Duisburg Germany. 
         [0124]    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 cover, or top plate, such as cover  162 , 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 which contains the flow channels by several means, including thermal bonding, sonic welding, laser welding, adhesive bonding and vacuum application. 
         [0125]    Thermal bonding may be preformed 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 interpenetrate with one another, the temperature is slowly reduced and a stress free bonded interface with imbedded micro channels is yielded. 
         [0126]    Additionally, the top plate, or cover 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. 
         [0127]    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 cover. 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. 
         [0128]    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. 
         [0129]    While the rate control plate, or base member  160  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 10-100 um. 
         [0130]    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. 
         [0131]    A typical rate control system of the invention will, by way of example, be able to deliver fluid at six specified flow rates as, for example 0.25, 0.5, 1.0, 2.0 and 5.0 ml/hr. For optimum performance, the flow rate should be constant and within 10% of the desired specified value. 
         [0132]    In operation, the flow of fluid 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 micron 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. 
         [0133]    The path that the micro channels take in any given rate control plate, or chip may be straight, a single meander or two or more meanders. The turns of the meanders 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 um to 500 um in length. 
         [0134]    Referring particularly to  FIG. 7 , reservoir  105   a  can also be filled using an alternate form of fill means of the invention that comprises septum fill means which includes the previously identified septum  122 . Septum  122  can be pierced by the piercing needle of a conventional syringe (not shown). In a conventional manner the fluid contained within the syringe can be caused to flow through the piercing needle which has pierced septum  122 , into passageway  118 , thence into passageway  140 . From passageway  140  the fluid will flow into inlet  105   b  of reservoir  105   a.    
         [0135]    Turning next to  FIGS. 27 through 46 , another form of the apparatus of the present invention is there illustrated and generally designated by the numeral  302 . This apparatus is similar in some respects to the apparatus shown in  FIGS. 1 through 26  and like numerals are used in  FIGS. 27 through 46  to identify like components. As best seen in  FIG. 27 , the primary difference between this latest form of the invention and that shown in  FIGS. 1 through 26  concerns the provision of a differently configured reservoir fill means for filling the device reservoir. More particularly, as will presently be described in greater detail, this alternate form of fill means comprises two fill vials or containers, rather than one. 
         [0136]    As best seen in  FIG. 27 , the apparatus here comprises an outer housing  304  having first and second portions  304   a  and  304   b  respectively. Disposed within outer housing  304   a  is an inner, expandable housing  105  which is identical in construction and operation to that described in connection with the embodiment of  FIGS. 1 through 26 . 
         [0137]    Also disposed within second portion  304   a  of the outer housing is the novel stored energy means of the invention for acting upon inner expandable housing  105  in a manner to cause the fluid contained within fluid reservoir  105   a  thereof to controllably flow outwardly of the housing. In this latest form of the invention, this stored energy means is also identical in construction and operation to that previously described and comprises a constant force spring  107 . 
         [0138]    With regard to the fill means of this latest form of the invention, which is also carried by first portion  304   a  of the outer housing, this important fill means functions to fill the reservoir  105   a  with the fluid to be dispensed. This fill means here comprises the previously described septum fill means, which is identical to that previously described and also includes a vial fill means which includes two, rather than the one, fill vial or fill container. 
         [0139]    As to the septum fill means, as illustrated in  FIG. 27 , second housing portion  304   b  includes a fluid passageway  306  which is in communication with inlet  308  of fluid reservoir  105   a.  Proximate its lower end  306   a,  fluid passageway  306  communicates with a cavity  309  formed within the second housing portion. Disposed within cavity  309  is a pierceable septum  310  that comprises a part of the septum fill means of this latest form of the invention. As before, septum  310  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  105   a  via passageway  306 . 
         [0140]    First portion  304   a  of the housing also includes a first chamber  312  for telescopically receiving a first medicament containing fill vial  314  and a second chamber  316  for receiving a second medicament containing vial  318 . The fill vials  314  and  318  are of identical construction to vial  130  of the earlier described embodiment. Telescopically receivable within each of the fluid chambers of the vials are elongated supports  320 . Each of the elongated supports  320  has an integrally threaded end portion  320   a  and each carries a longitudinally extending, elongated hollow needle  322 . Each of the hollow needles  322  has a flow passageway that communicates with a fluid passageway  324  provided in housing portion  304   b  ( FIG. 27 ). First chamber  312 , second chamber  316 , elongated supports  320 , and hollow needles  322  together comprise the alternate form of the vial fill means of the apparatus of the invention. The method of operation of this alternate form of fill means will presently be described. 
         [0141]    A number of beneficial agents can be contained within vials  314  and  318  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. 
         [0142]    Forming another very important aspect of the apparatus of this latest form of the invention is a novel flow control means that are carried by second portion  304   b  of outer housing  304 . This flow control means which is identical in construction and operation to that described in connection with the first embodiment of the invention, functions to precisely control the outwardly rate of fluid flow from reservoir  105   a  and toward the patient. As before, the flow control means comprises an assembly which includes a base plate, or rate control member  160  and a mating cover member  162  ( FIG. 21 ). As illustrated in  FIG. 22 , flow rate control member, or base plate  160  is uniquely provided with a plurality of micro rate flow control channels  160   a,    160   b,    160   c,    160   d  and  160   e  respectively, which are in communication with the spaced apart micro rate outlet ports of the cover member  162 . Flow rate control member, or base plate  160  is also uniquely provided with a plurality of macro rate flow control channels  173   a,    173   b,    173   c,    173   d  and  173   e  respectively, which are in communication with the spaced apart macro rate outlet ports of the cover member  162 . 
         [0143]    Also forming a part of the flow control means of this latest form of the invention is a micro rate selector knob  180  that is carried within a horizontal bore  182  formed in housing portion  304   b.  Selector knob  180  is of identical construction and operation to the selector knob described in connection with the first embodiment of the invention and is uniquely provided with a plurality of radially extending flow control channels  184   a,    184   b,    184   c,    184   d  and  184   e,  each having an inlet port and an outlet port which is in fluid communication with an axially extending passageway  186 . Axially extending passageway  186  is, in turn, in fluid communication with administration line  148 , which is also of identical construction and operation to that described in connection with the first embodiment of the invention. 
         [0144]    Micro selector knob  180 , which comprises a part of the selector means of this latest form of the invention, functions to selectively align one of the inlets of the radially extending flow control channels of the selector knob with a selected one of the spaced apart micro rate fluid outlets  166   a,    166   b ,  166   c,    166   d  and  166   e  of the rate control cover  162  ( FIG. 18 ). 
         [0145]    Also forming a part of the flow control means of this latest form of the invention is a macro rate selector knob  190  that is carried within a horizontal bore  192  formed in housing portion  304   b.  Selector knob  190  is also of identical construction and operation to selector knob  190  as described in connection with the first embodiment of the invention and is uniquely provided with a plurality of radially extending flow control channels  194   a ,  194   b,    194   c,    194   d  and  194   e,  each having an inlet port and an outlet port which it is in fluid communication with an axially extending passageway  196 . Axially extending passageway  196  is, in turn, in fluid communication with administration line  148 . 
         [0146]    Selector knob  190 , which also comprises a part of the selector means of this latest form of the invention, functions to selectively align one of the inlets of the radially extending flow control channels of the macro selector knob with a selected one of the spaced apart macro rate fluid outlets  170   a ,  170   b,    170   c,    170   d  and  170   e  of the rate control cover  162  (see  FIG. 18 ). 
         [0147]    In using the apparatus of this latest form of the invention, following removal of the vial cover  327 , which forms a part of the first portion of housing  304  ( FIGS. 27 and 36 ), vials  314  and  318  can be inserted into chambers  312  and  316  respectively. As the fill vials are so introduced and the plungers  136  are threadably interconnected with ends  320   a  of supports  320 , the sharp ends of the elongated needles  322  will pierce the central walls  136   a  of the elastomeric plungers. Continuous movement of the vials into chambers  312  and  316  will cause the structural supports  320  to move the elastomeric plungers inwardly of the vial chambers. As the plungers move inwardly of the vials, the fluid contained within the vial chambers will be expelled therefrom into the hollow elongated needles  322 . As best seen in  FIG. 27 , the fluid will then flow past umbrella type check valves  116  and into stub passageways  330  formed in second portion  304   b  of the apparatus housing. From passageways  330  the fluid will flow into passageway  324  and then into reservoir  105   a  of the bellows component  105  via inlet  308 . It is to be understood that the vials  316  and  318  can contain the same or different medicinal fluids and can be introduced into their respective chambers either one at a time, or simultaneously. 
         [0148]    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  310  which is mounted within second portion  304   b  of the apparatus housing. As the reservoir  105   a  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  304   b  of the housing. 
         [0149]    As the fluid flows into reservoir  105   a,  the bellows  105   d  will expand in a manner to exert a rearward pressure on the plunger end portion  109   a  of pusher member  109  causing it to move rearwardly. As the pusher member moves rearwardly, it will exert forces on spring member  107  causing it to it to expand from its retracted configuration shown in  FIG. 27  to its expanded configuration. This rearward movement of pusher member  109  can be viewed through the volume indicator window  142  indicating that the reservoir has changed from an empty configuration to a filled configuration ( FIG. 1 ). 
         [0150]    As before selector knobs  180  and  190  are provided with a plurality of circumferentially spaced apart indexing cavities that closely receive the ends of the indexing fingers of outwardly extending locking arms  208 , which forms a part of the flow control means of the invention and function to prevent rotation of the selector knobs (see  FIGS. 6 and 13 ). Similarly disabling means of the character previously described can be used to disable the apparatus of this latest form of the invention. 
         [0151]    Turning next to  FIGS. 37 through 46 , still another form of the apparatus of the present invention is there illustrated and generally designated by the numeral  402 . This alternate form of the apparatus of the invention is also similar in many respects to that shown in  FIGS. 1 through 26  and like numerals are used in  FIGS. 37 through 46  to identify like components. The primary difference between this latest form of the invention and that shown in  FIGS. 1 through 26  is that the vial fill means for filling the device reservoir is of a different configuration from that used in both the first and second, previously described embodiments of the invention. More particularly, as will presently be described in greater detail, this alternate form of vial fill means comprises a vial cartridge having a hollow glass or plastic body portion that defines a fluid chamber that is closed by a pierceable, elastomeric septum. 
         [0152]    As best seen in  FIG. 37 , the apparatus here comprises an outer housing  404  having first and second portions  404   a  and  404   b  respectively. Disposed within outer housing  404  is an inner, expandable housing  105  which is identical in construction and operation to that described in connection with the embodiment of  FIGS. 1 through 26 . 
         [0153]    Also disposed within housing  404  is the novel stored energy means of the invention for acting upon expandable housing  105  in a manner to cause the fluid contained within fluid reservoir  105   a  thereof to controllably flow outwardly of the housing. In this latest form of the invention, this stored energy means is also identical in construction and operation to that previously described and comprises a constant force spring  107 . 
         [0154]    With regard to the fill means of this latest form of the invention, which is carried by the first portion  404   a  of the outer housing, as before, this important fill means functions to fill the reservoir  105   a  with the fluid to be dispensed. This fill means here comprises the previously described septum fill means which is identical to that previously described, and also includes the previously mentioned, cartridge type vial fill vial which is of the construction best seen in  FIG. 37  of the drawings. As to the septum fill means, as illustrated in  FIG. 37 , second portion  404   b  includes a fluid passageway  408  which is in communication with inlet  410  of fluid reservoir  105   a.  Proximate its lower end  408   a,  fluid passageway  408  communicates with a cavity  414  formed within the second portion  404   b  of the housing. Disposed within cavity  414  is a pierceable septum  416  that comprises a part of the septum fill means of this latest form of the invention. As before, septum  416  is held in position by a retainer  416   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  105   a  via passageway  408 . 
         [0155]    First portion  404   a  of the housing also includes a first chamber  418  for telescopically receiving the previously mentioned cartridge fill vial, which is generally designated in the drawings by the numeral  420 . As shown in  FIG. 37 , cartridge fill vial  420  comprises a hollow glass or plastic body portion  422  that defines a fluid chamber  422   b.  Fill vial  420  has an open first end  422   a  and a second end  424  that is closed by a pierceable, elastomeric septum  426 . An elastomeric plunger  428  is reciprocally movable within fluid chamber  424 . As shown in  FIG. 37 , a hollow needle  430  is mounted within second portion  404   b  of the device housing and is located proximate the inboard end of chamber  424 . Hollow needle  430  is adapted to pierce septum  426  when the fill vial is inserted into chamber  418  and pushed into the position shown in  FIG. 37 . 
         [0156]    A number of beneficial agents can be contained within vial  420  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. 
         [0157]    Forming an important aspect of the apparatus of this latest form of the invention is a novel flow control means that is carried by second portion  404   b  of outer housing  404 . This flow control means which is identical in construction and operation to that described in connection with the first embodiment of the invention, functions to precisely control the outwardly rate of fluid flow from reservoir  105   a  and toward the patient. 
         [0158]    As before, the flow control means comprises an assembly which includes a base plate, or rate control member  160  and a mating cover member  162  ( FIG. 21 ). As illustrated in  FIG. 22 , flow rate control member, or base plate  160  is uniquely provided with a plurality of micro rate flow control channels  160   a,    160   b,    160   c,    160   d  and  160   e  respectively, which are in communication with the spaced apart micro rate outlet ports of the cover member  162 . Flow rate control member, or base plate  160  is also uniquely provided with a plurality of macro rate flow control channels  173   a ,  173   b,    173   c,    173   d  and  173   e  respectively, which are in communication with the spaced apart macro rate outlet ports of the cover member  162 . 
         [0159]    Also forming a part of the flow control means of this latest form of the invention is a micro rate selector knob  180  that is carried within a horizontal bore  182  formed in housing portion  404   b.  Selector knob  180  is of identical construction and operation to the selector knob described in connection with the first embodiment of the invention and is uniquely provided with a plurality of radially extending flow control channels  184   a,    184   b,    184   c,    184   d  and  184   e,  each having an inlet port and an outlet port which is in fluid communication with an axially extending passageway  186 . Axially extending passageway  186  is, in turn, in fluid communication with administration line  148 , which is also of identical construction and operation to that described in connection with the first embodiment of the invention. 
         [0160]    Micro selector knob  180 , which comprises a part of the selector means of this latest form of the invention, functions to selectively align one of the inlets of the radially extending flow control channels of the selector knob with a selected one of the spaced apart micro rate fluid outlets  166   a,    166   b ,  166   c,    166   d  and  166   e  of the rate control cover  162  ( FIG. 18 ). 
         [0161]    Also forming a part of the flow control means of this latest form of the invention is a macro rate selector knob  190  that is carried within a horizontal bore  192  formed in housing portion  404   b.  Selector knob  190  is also of identical construction and operation to selector knob  190  as described in connection with the first embodiment of the invention and is uniquely provided with a plurality of radially extending flow control channels  194   a ,  194   b,    194   c,    194   d  and  194   e,  each having an inlet port and an outlet port which it is in fluid communication with an axially extending passageway  196 . Axially extending passageway  196  is, in turn, in fluid communication with administration line  148 . 
         [0162]    Selector knob  190 , which also comprises a part of the selector means of this latest form of the invention, functions to selectively align one of the inlets of the radially extending flow control channels of the macro selector knob with a selected one of the spaced apart macro rate fluid outlets  170   a ,  170   b,    170   c,    170   d  and  170   e  of the rate control cover  162  (see  FIG. 18 ). 
         [0163]    In using the apparatus of this latest form of the invention, following removal of the vial cover  433 , which forms a part of the first portion of housing  404  ( FIGS. 37 and 46 ), vial  420  can be inserted into chamber  418 . As previously mentioned, plunger  428  is disposed within vial  420  and is moved by a support  436  of a vial cover  433  ( FIG. 46 ) as the vial cover is mated with the apparatus housing. As plunger  428  moves inwardly of vial reservoir  424 , the fluid contained in the reservoir will be forced through hollow needle  430 , passed the umbrella check valve  116  mounted within third housing portion  405 , into a stub passageway  440 , into passageway  408  and finally into reservoir  105   a  of the bellows component  105  via inlet  410 . 
         [0164]    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  416  which is mounted within second portion  404   b  of the apparatus housing. As the reservoir  105   a  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  404   b  of the housing. 
         [0165]    As the fluid flows into reservoir  105   a,  the bellows  105   d  will expand in a manner to exert a rearward pressure on the plunger end portion  109   a  of pusher member  109  causing it to move rearwardly. As the pusher member moves rearwardly, it will exert forces on spring member  107  causing it to expand from its retracted configuration shown in  FIG. 37  to its expanded configuration. This rearward movement of pusher member  109  can be viewed through the volume indicator window  142  indicating that the reservoir has changed from an empty configuration to a filled configuration ( FIG. 1 ). 
         [0166]    As before selector knobs  180  and  190  are provided with a plurality of circumferentially spaced apart indexing cavities that closely receive the ends of the indexing fingers of outwardly extending locking arms  208 , which forms a part of the flow control means of the invention and function to prevent rotation of the selector knobs (see  FIGS. 6 and 13 ). Similarly disabling means of the character previously described can be used to disable the apparatus of this latest form of the invention. 
         [0167]    Turning next to  FIGS. 47 through 56 , still another form of the apparatus of the present invention is there illustrated and generally designated by the numeral  502 . This alternate form of the apparatus of the invention is similar in some respects to the apparatus shown in  FIGS. 27 through 46  and like numerals are used in  FIGS. 47 through 56  to identify like components. As best seen in  FIG. 47 , the primary difference between this latest form of the invention and that shown in  FIGS. 27 through 46  concerns the provision of a differently configured reservoir fill means for filling the device reservoir. More particularly, as will presently be described in greater detail, this alternate form of fill means comprises two fill vials or containers, rather than one. 
         [0168]    As best seen in  FIG. 47 , the apparatus here comprises an outer housing  504  having first and second portions  504   a  and  504   b  respectively. Disposed within outer housing  504   a  is an inner, expandable housing  105  which is identical in construction and operation to that described in connection with the embodiment of  FIGS. 1 through 26 . 
         [0169]    Also disposed within second portion  504   a  of the outer housing is the novel stored energy means of the invention for acting upon inner expandable housing  105  in a manner to cause the fluid contained within fluid reservoir  105   a  thereof to controllably flow outwardly of the housing. In this latest form of the invention, this stored energy means is also identical in construction and operation to that previously described and comprises a constant force spring  107 . 
         [0170]    With regard to the fill means of this latest form of the invention, which is also carried by first portion  504   a  of the outer housing, this important fill means functions to fill the reservoir  105   a  with the fluid to be dispensed. This fill means comprises the previously described septum fill means which is identical to that previously described, and also includes a vial fill means which includes two, rather than the one, fill vial or fill container. 
         [0171]    As to the septum fill means, as illustrated in  FIG. 47 , second housing portion  504   b  includes a fluid passageway  506  which is in communication with inlet  508  of fluid reservoir  105   a.  Proximate its lower end  506   a,  fluid passageway  506  communicates with a cavity  509  formed within the second housing portion. Disposed within cavity  509  is a pierceable septum  510  that comprises a part of the septum fill means of this latest form of the invention. 
         [0172]    As before, septum  510  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  105   a  via passageway  506 . 
         [0173]    First portion  504   a  of the housing also includes a first chamber  512  for telescopically receiving the first medicament containing fill vial  420  and a second chamber  516  for receiving a second medicament containing vial  518 . First vial  420 , which is of identical construction to vial  420  of the earlier described embodiment, comprises a vial cartridge having a hollow glass or plastic body portion that defines a fluid chamber that is closed by a pierceable, elastomeric septum. However, the second vial cartridge  518  is of a uniquely different construction from the previously described medicament containing vials. More particularly, as will be discussed in greater detail hereinafter, this second vial cartridge is specially designed to enable the intermixing of a lypholized drug with suitable diluents prior to the delivery of the mixture to the fluid reservoir of the device. 
         [0174]    A number of beneficial agents can be contained within vials  420  and  518  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. 
         [0175]    As in the earlier described embodiments of the invention, another very important aspect of the apparatus of this latest form of the invention is a novel flow control means that are carried by second portion  504   b  of outer housing  504 . This flow control means which is identical in construction and operation to that described in connection with the first embodiment of the invention, functions to precisely control the outwardly rate of fluid flow from reservoir  105   a  and toward the patient. As before, the flow control means comprises an assembly which includes a base plate, or rate control member  160  and a mating cover member  162  ( FIG. 21 ). As illustrated in  FIG. 22 , flow rate control member, or base plate  160  is uniquely provided with a plurality of micro rate flow control channels  160   a,    160   b,    160   c,    160   d  and  160   e  respectively, which are in communication with the spaced apart micro rate outlet ports of the cover member  162 . Flow rate control member, or base plate  160  is also uniquely provided with a plurality of macro rate flow control channels  173   a,    173   b,    173   c,    173   d  and  173   e  respectively, which are in communication with the spaced apart macro rate outlet ports of the cover member  162 . 
         [0176]    Also forming a part of the flow control means of this latest form of the invention is a micro rate selector knob  180  that is carried within a horizontal bore  182  formed in member  406 . Selector knob  180  is of identical construction and operation to the selector knob described in connection with the first embodiment of the invention and is uniquely provided with a plurality of radially extending flow control channels  184   a,    184   b,    184   c,    184   d  and  184   e,  each having an inlet port and an outlet port which is in fluid communication with an axially extending passageway  186 . Axially extending passageway  186  is, in turn, in fluid communication with administration line  148 , which is also of identical construction and operation to that described in connection with the first embodiment of the invention. 
         [0177]    Micro selector knob  180 , which comprises a part of the selector means of this latest form of the invention, functions to selectively align one of the inlets of the radially extending flow control channels of the selector knob with a selected one of the spaced apart micro rate fluid outlets  166   a,    166   b ,  166   c,    166   d  and  166   e  of the rate control cover  162  ( FIG. 18 ). 
         [0178]    Also forming a part of the flow control means of this latest form of the invention is a macro rate selector knob  190  that is carried within a horizontal bore  192  formed in member  405 . Selector knob  190  is also of identical construction and operation to selector knob  190  as described in connection with the first embodiment of the invention and is uniquely provided with a plurality of radially extending flow control channels  194   a,    194   b,    194   c,    194   d  and  194   e,  each having an inlet port and an outlet port which it is in fluid communication with an axially extending passageway  196 . Axially extending passageway  196  is, in turn, in fluid communication with administration line  148 . 
         [0179]    Selector knob  190 , which also comprises a part of the selector means of this latest form of the invention, functions to selectively align one of the inlets of the radially extending flow control channels of the macro selector knob with a selected one of the spaced apart macro rate fluid outlets  170   a ,  170   b,    170   c,    170   d  and  170   e  of the rate control cover  162  (see  FIG. 18 ). 
         [0180]    With respect to cartridge fill vial  420 , as before, this fill vial comprises a hollow glass or plastic body portion  422  that defines a fluid chamber  424 . Fill vial  420  has an open first end  422   a  and a second end  424  that is closed by a pierceable, elastomeric septum  426 . An elastomeric plunger  428  is reciprocally movable within fluid chamber  424 . As shown in  FIG. 47 , a hollow needle to  430  is mounted within second portion  504   b  of the device housing and is located proximate the inboard end of chamber  424 . 
         [0181]    With respect to second cartridge fill vial  518 , this vial comprises a container of special design that includes a chamber  519  and uniquely contains a lyophilized drug  537  that is separated from a reconstituting fluid  539  by a barrier stopper  542  ( FIG. 47A ). Lyophilized drug  537  can, by way of example, comprise anti-infectives or various other types of beneficial agents. Second fill vial  518  also includes an elastomeric plunger  544  that is reciprocally movable within fluid chamber  519 . 
         [0182]    As illustrated in  FIGS. 47 and 56 , the removable cover  523  of the device housing includes a pair of spaced apart pusher members  544  and  546  which engage plungers  428  and  544  respectively to push them forwardly of their respective container chambers. 
         [0183]    Considering in more detail the novel vial assembly  518 , as best seen in  FIG. 47A , this vial assembly comprises a vial  545  that is sealed at one end by plunger  544  and at the other end by a pierceable septum  548  ( FIGS. 47 and 47A ). Formed intermediate the ends of vial  545  is a raised outer wall portion  547  which permits fluid  539  to bypass a barrier stopper  542  as the barrier stopper is urged inwardly of the container by pressure exerted thereon by the fluid  539 . Fluid  539  exerts pressure on barrier member  542  as a result of pusher member  546  exerting inward pressure on plunger  544 , which pressure is, in turn, caused by the inward movement of plunger  544  as the cover  523  is mated with the apparatus housing. 
         [0184]    A continued inward pressure exerted on plunger  544  will cause fluid  539  to flow past barrier member  542  via wall portion  547  so as to reconstitute lyophilized drug  537 . Continued pressure exerted on plunger  543  will cause the reconstituted drug formed by the fluid  539  which has been intermixed with drug  537  to flow through a hollow needle  550  which is carried by housing portion  504   b,  past a lower check valve  552 , into a stub passageway  554 , then into passageway  506  and finally into the device reservoir  105   a.    
         [0185]    As the vial cover  523  is mated with the apparatus housing, pusher member  544  engages plunger  428  of vial  420  and moves it inwardly of vial reservoir  424 . Continued inward movement of the pusher member causes the fluid contained in the reservoir to be forced through a hollow needle  430 , passed the upper umbrella check valve  556  mounted within second housing portion  504   b,  into a stub passageway  558 , into a passageway  506  and finally into the device reservoir. 
         [0186]    As the fluid flows into reservoir  105   a,  it will compress the stored energy means, or constant force spring  107  in the manner previously described. 
         [0187]    Upon opening the fluid delivery path to the administration set, the stored energy means, or member  107 , will tend to return to its starting configuration thereby controllably urging fluid flow outwardly of reservoir  105   a  via the flow control means of the invention which functions in the manner previously described. 
         [0188]    As in the earlier described embodiments, disabling means of the character previously described can be used to disable the apparatus of this latest form of the invention. 
         [0189]    Turning next to  FIGS. 57 through 67 , another form of the apparatus of the present invention is there illustrated and generally designated by the numeral  602 . This apparatus is similar in some respects to the apparatus shown in  FIGS. 37 through 46  and like numerals are used in  FIGS. 57  through  67  to identify like components. As best seen in  FIG. 57 , the primary difference between this latest form of the invention and that shown in  FIGS. 37 through 46  concerns the provision of a differently configured reservoir fill means for filling the device reservoir. More particularly, as will presently be described in greater detail, this alternate form of fill means comprises two cartridge type fill vials or containers, rather than one. 
         [0190]    As best seen in  FIG. 57 , the apparatus here comprises an outer housing  604  having first and second portions  604   a  and  604   b  respectively. Disposed within outer housing  604   a  is an inner, expandable housing  105  which is identical in construction and operation to that described in connection with the embodiment of  FIGS. 1 through 26 . 
         [0191]    Also disposed within second portion  604   a  of the outer housing is the novel stored energy means of the invention for acting upon inner expandable housing  105  in a manner to cause the fluid contained within fluid reservoir  105   a  thereof to controllably flow outwardly of the housing. In this latest form of the invention, this stored energy means is also identical in construction and operation to that previously described and comprises a constant force spring  107 . 
         [0192]    With regard to the fill means of this latest form of the invention, which is also carried by first portion  604   a  of the outer housing, this important fill means functions to fill the reservoir  105   a  with the fluid to be dispensed. This fill means comprises the previously described septum fill means, which is identical to that previously described and also includes a vial fill means which includes two, rather than the one, fill vial or fill container. 
         [0193]    As to the septum fill means, as illustrated in  FIG. 57 , second housing portion  604   b  includes a fluid passageway  606  which is in communication with inlet  608  of fluid reservoir  105   a.  Proximate its lower end  606   a,  fluid passageway  606  communicates with a cavity  609  formed within the second housing portion. Disposed within cavity  609  is a pierceable septum  610  that comprises a part of the septum fill means of this latest form of the invention. As before, septum  610  is pierceable by the needle of a syringe which contains the medicinal fluid to be dispensed and which can be used in a conventional manner to fill or partially fill reservoir  105   a  via passageway  606 . 
         [0194]    First portion  604   a  of the housing also includes a first chamber  612  for telescopically receiving a first medicament containing fill vial  420  and a second chamber  616  for receiving a second medicament containing vial  420 . The fill vials  420  are of identical construction and operation to vial  420  of the earlier described embodiment and the details of their construction will not here be repeated. 
         [0195]    A number of beneficial agents can be contained within the two vials  420  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. 
         [0196]    Forming another very important aspect of the apparatus of this latest form of the invention is a novel flow control means that are carried by second portion  604   b  of outer housing  604 . This flow control means, which is identical in construction and operation to that described in connection with the first embodiment of the invention, functions to precisely control the rate outwardly of fluid flow from reservoir  105   a  and toward the patient. As before, the flow control means comprises an assembly which includes a base plate, or rate control member  160  and a mating cover member  162  ( FIG. 21 ). As illustrated in  FIG. 22 , flow rate control member, or base plate  160  is uniquely provided with a plurality of micro rate flow control channels  160   a,    160   b,    160   c,    160   d  and  160   e  respectively, which are in communication with the spaced apart micro rate outlet ports of the cover member  162 . Flow rate control member, or base plate  160  is also uniquely provided with a plurality of macro rate flow control channels  173   a,    173   b,    173   c,    173   d  and  173   e  respectively, which are in communication with the spaced apart macro rate outlet ports of the cover member  162 . 
         [0197]    Also forming a part of the flow control means of this latest form of the invention is a micro rate selector knob  180  that is carried within a horizontal bore  182  formed in housing portion  604   b.  Selector knob  180  is of identical construction and operation to the selector knob described in connection with the first embodiment of the invention and is uniquely provided with a plurality of radially extending flow control channels  184   a,    184   b,    184   c,    184   d  and  184   e,  each having an inlet port and an outlet port which is in fluid communication with an axially extending passageway  186 . Axially extending passageway  186  is, in turn, in fluid communication with administration line  148 , which is also of identical construction and operation to that described in connection with the first embodiment of the invention. 
         [0198]    Micro selector knob  180 , which comprises a part of the selector means of this latest form of the invention, functions to selectively align one of the inlets of the radially extending flow control channels of the selector knob with a selected one of the spaced apart micro rate fluid outlets  166   a,    166   b ,  166   c,    166   d  and  166   e  of the rate control cover  162  ( FIG. 18 ). 
         [0199]    Also forming a part of the flow control means of this latest form of the invention is a macro rate selector knob  190  that is carried within a horizontal bore  192  formed in housing portion  604   b.  Selector knob  190  is also of identical construction and operation to selector knob  190  as described in connection with the first embodiment of the invention and is uniquely provided with a plurality of radially extending flow control channels  194   a ,  194   b,    194   c,    194   d  and  194   e,  each having an inlet port and an outlet port which it is in fluid communication with an axially extending passageway  196 . Axially extending passageway  196  is, in turn, in fluid communication with administration line  148 . 
         [0200]    Selector knob  190 , which also comprises a part of the selector means of this latest form of the invention, functions to selectively align one of the inlets of the radially extending flow control channels of the macro selector knob with a selected one of the spaced apart macro rate fluid outlets  170   a ,  170   b,    170   c,    170   d  and  170   e  of the rate control cover  162  (see  FIG. 18 ). 
         [0201]    In using the apparatus of this latest form of the invention, following removal of the vial cover  623 , which forms a part of the first portion of housing  604  ( FIGS. 57 and 67 ), vials  420  can be inserted into chambers  612  and  616 . As previously mentioned, plungers  428  are disposed within vials  420  and are moved by supports  626  of a vial cover  623  ( FIGS. 57 and 67 ) as the vial cover is mated with the apparatus housing. As the plungers  428  move inwardly of their respective vial reservoirs  424 , the fluid contained in the reservoirs will be forced through hollow needles  430 , passed the umbrella check valves  116  mounted within housing portion  604   b , into a stub passageways  630 , into passageway  606  and finally into reservoir  105   a  of the bellows component  105  via inlet  608 . 
         [0202]    It is also to be understood that, if desired, the reservoir of the bellows component can also be filled by alternate septum filling means of the character previously described. As the reservoir  105   a  fills with fluid either from the fill vials or from the filling syringe of the alternate septum filling means, any gases trapped within the reservoir will be vented to atmosphere via vent means “V”, mounted in portion  604   b  of the housing. 
         [0203]    As the fluid flows into reservoir  105   a,  the bellows  105   d  will expand in a manner to exert a rearward pressure on the plunger end portion  109   a  of pusher member  109  causing it to move rearwardly. As the pusher member moves rearwardly, it will exert forces on spring member  107  causing it to it to expand from its retracted configuration shown in  FIG. 57  to its expanded configuration. This rearward movement of pusher member  109  can be viewed through the volume indicator window  142  indicating that the reservoir has changed from an empty configuration to a filled configuration ( FIG. 1 ). 
         [0204]    As before selector knobs  180  and  190  are provided with a plurality of circumferentially spaced apart indexing cavities that closely receive the ends of the indexing fingers of outwardly extending locking arms  208 , which forms a part of the flow control means of the invention and function to prevent rotation of the selector knobs (see  FIGS. 6 and 13 ). Similarly disabling means of the character previously described can be used to disable the apparatus of this latest form of the invention. 
         [0205]    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.

Technology Classification (CPC): 0