Abstract:
A fluid delivery apparatus for infusing medicinal fluids into a patient which is of a compact, low profile, laminate construction. The apparatus embodies a novel thermal expanding polymer material which uniquely functions as an internal energy source for expelling the medicinal fluids from the device. The apparatus can be used for subdermal, intradermal and intramuscular infusion of fluids and in one form of the invention, includes a novel delivery cannula having a body portion disposed within a circuitous channel formed within the base superstructure of the apparatus and a pierceable portion which extends outwardly from the base of the apparatus. By constructing the cannula in a circuitous configuration and dynamically connecting it to the base assembly, movement of the cannula relative to the base assembly is permitted thereby minimizing needle related tissue necrosis. The heat-expandable mass which is heated by the patient&#39;s body temperature in a manner to controllably expel fluid from the device uniquely functions to provide a conformable ullage within the reservoir of the device which will effectively avoid extended flow delivery rate trail-off at the end of the fluid delivery period. Further, the heat expandable mass can be specifically tailored to provide precise, predictable protocol delivery of the medicinal agent stored within the reservoir of the device.

Description:
This is a Continuation-In-Part of co-pending application Ser. No. 09/387,447 filed Sep. 1, 1999, now allowed, which is a Divisional application of co-pending application Ser. No. 08/919,147 filed Aug. 27, 1997, now U.S. Pat. No. 5,961,492. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     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. 
     2. Discussion of the Invention 
     The oral route is the most frequent route of drug administration. Oral administration is relatively easy for most patients and rarely causes physical discomfort. However, many medicinal agents require a parenteral route of 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 my 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. 
     In the past, prolonged infusion of fluids has generally been accomplished using gravity flow means coupled with electronic based controls and typically involve the use of intravenous administration sets and the familiar bottle or solution bag suspended above the patient. Such methods are cumbersome, imprecise and, generally non-ambulatory requiring 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 of the character from which liquid is expelled from a relatively thick-walled bladder by internal stresses within the distended bladder have also been suggested for infusion of medicaments. For example, 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. 
     A family of highly unique fluid delivery devices has been developed by the present inventor. These novel devices make use of recently developed elastomeric films, expandable foams and similar materials, which, in cooperation with a base define a fluid chamber that contains the fluid to be dispensed. The elastomeric film membrane or the expandable member controllably forces fluid within the chamber into outlet fluid flow channels provided in the device. Elastomeric film membrane devices are described in detail in U.S. Pat. No. 5,205,820 issued to the present inventor. U.S. Pat. No. 5,468,226, also issued to the present inventor, describes various types of expandable cellular elastomers and elastomeric foams used as the energy source of the fluid delivery device for expelling fluid from various physical forms of the fluid delivery device. Because of the pertinence of U.S. Pat. Nos. 5,205,820 and 5,468,226, these patents are hereby incorporated herein by reference in their entirety as though fully set forth herein. Copending U.S. Application Ser. No. 08/541,030, filed Oct. 11, 1996 in which the present inventor is named as co-inventor, is also pertinent to one form of the apparatus of the invention which is described hereinafter. Accordingly, Ser. No. 08/541,030 is also hereby incorporated by reference as though fully set forth herein. 
     U.S. Ser. No. 08/919,147, now U.S. Pat. No. 5,961,492 is also incorporated by reference as though fully set forth herein. 
     The apparatus of the present invention, which takes various physical forms, makes use of novel temperature expansive material as an energy source. This family of devices can also 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 and can be used with or without remotely located infusion sets 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. 
     One of the embodiments of the present invention comprises an ambulatory fluid dispensing system which includes a relatively thin body attached rigid base assembly and a uniquely designed stored energy means which cooperates with the base assembly for controllably expelling fluid from the reservoir of the device. In this form of the invention, the stored energy means is provided in the form of a heat expandable gel, the nature of which will be described in greater detail hereinafter. In this particular form of the invention, a novel, remotely located subcutaneous infusion set can be quickly coupled to the base assembly to enable precise infusion of fluid to a patient upon stimulation of the expandable gel by the gel stimulation means of the invention. 
     Another embodiment of the invention comprises an ambulatory fluid dispensing system which includes a rigid base assembly and a uniquely designed stored energy means which cooperates with the base assembly for controllably expelling fluid from the reservoir of the device. In this latter form of the invention, the stored energy means is also provided in the form of an expandable gel and a remotely located subcutaneous infusion set can be quickly coupled to the base assembly to enable precise infusion of fluid to a patient upon stimulation of the expandable gel caused by operator energization of a battery powered heating element. 
     Alternatively, in other embodiments of the invention, infusion is accomplished by infusion means integrally formed with the base assembly. 
     In still other embodiments of the invention which also use a heat expandable gel as an energy source, medicinal fluids are delivered to the patient from the fluid dispenser via various types of infusion means. By way of example, such dispensers can accomplish parenteral administration of a beneficial agent by the subcutaneous, subdermal, intradermal, intramuscular or intravenous routes. Subcutaneous injection places the drug into the tissues between the skin and the muscle. Drugs administered in this manner are absorbed somewhat slowly. When the beneficial agent is administered subcutaneously, the needle can be inserted at a 45 degree angle or, in some cases, as with obese patients, at a 90 degree angle. A beneficial agent administered by the intravenous route is given directly into the blood by a needle inserted into a vein. In such instances, action occurs almost immediately. An intramuscular injection is the administration of a beneficial agent into a muscle. Agents given by this route are absorbed more rapidly than those given by the subcutaneous route. In addition, a larger volume (1-5 mL) can be given at one site. The sites for intramuscular administration are the deltoid muscle (upper arm), the ventrogluteal or dorsogluteal sites (hip), and the vastus lateralis (thigh). When giving a beneficial drug by the intramuscular route, the needle of the infusion means is preferably inserted at a 90 degree angle. 
     The primary thrust of the various inventions described herein is to provide novel expandable gel type fluid delivery systems which are compact, easy to use, relatively low profile and are eminently capable of meeting even the most stringent of fluid delivery tolerance requirements. In this regard, medical and pharmacological research continues to reveal the importance of the manner in which a medicinal agent is administered. For example, certain classes of pharmacological agents possess a very narrow dosage range of therapeutic effectiveness, in which case too small a dose will have no effect, while too great a dose can result in toxic reaction. In other instances, some forms of medication require an extended delivery time to achieve the utmost effectiveness of a medicinal therapeutic regimen. 
     SUMMARY OF THE INVENTION 
     It is an object of the present invention to provide a technically advanced, fluid delivery apparatus for infusing medicinal fluids into a patient which is of a compact, low profile, laminate construction. More particularly, it is an object of the invention to provide an apparatus of such a character which embodies a novel expanding polymer gel material which uniquely functions as an internal energy source for expelling the medicinal fluids from the device. 
     Another object of the invention is to provide an ambulatory fluid delivery apparatus which can conveniently be used for the precise infusion of various pharmaceutical fluids into an ambulatory patient at controlled rates over extended periods of time. 
     Another object of the invention is to provide an apparatus of the aforementioned character which is highly reliable and easy-to-use by lay persons in a non-hospital environment. 
     Another object of the invention is to provide an apparatus as described in the preceding paragraphs which can be used for subdermal, intradermal and intramuscular infusion of fluids. In this regard, in one form of the invention, the apparatus includes a novel and unique delivery cannula having a body portion disposed within a circuitous channel formed within the base superstructure of the apparatus and a pierceable portion which extends outwardly from the base of the apparatus. By constructing the cannula in a circuitous configuration and dynamically connecting it to the base assembly, movement of the cannula relative to the base assembly is permitted thereby minimizing needle related tissue necrosis. 
     Another object of the invention is to provide an apparatus which embodies as its stored energy source, a soft, pliable, semi-solid, heat-expandable mass which is heated either by the patient&#39;s body temperature or by an external stimulus in a manner to controllably expel fluid from the device. 
     Another object of the invention is to provide an apparatus as described in the preceding paragraph in which the heat expandable mass is specifically tailored to provide precise, predictable protocol delivery of the medicinal agent stored within the reservoir of the device. 
     Another object of the invention is to provide an apparatus of the class described which includes novel means for indicating the presence of fluid within the reservoir and for also indicating fluid flow from the reservoir. 
     A further object of the invention is to provide a low profile, fluid delivery low profile, body attaching fluid delivery device of laminate construction which can meet even the most stringent fluid delivery tolerance and flow signature requirements. 
     Another object of the invention is to provide an apparatus of the character described which is responsive to an external source of stimulation such as heat and radiation, and includes a three-dimensional polymer network which functions as a stored energy source that can be constructed from various types of polymeric conformable materials such as phase transition gels. 
     Another object of the invention is to provide stored energy sources of the character described in the preceding paragraph which comprise blends or laminate constructions of phase transition gels that will enable the achievement of multi-rate delivery protocols. 
     Another object of the invention is to provide an apparatus of the character described which includes a novel, combination filter and rate control assemblage disposed intermediate the fluid reservoir and the outlet port of the device or intermediate outlet port of the device and the infusion means. 
     Another object of the invention is to provide an apparatus of the character described which, due to its unique construction, can be manufactured inexpensively in large volume by automated machinery. 
     Other objects of the invention are set forth in U.S. Pat. Nos. 5,205,820 and 5,468,226, which patents are incorporated herein by reference. Still further objects of the invention will become apparent from the discussion which follows. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a top plan view of one form of the fluid delivery apparatus of the invention. 
     FIG. 2 is a side elevational view of the device shown in FIG.  1 . 
     FIG. 3 is a cross-sectional view taken along lines  3 — 3  of FIG.  1 . 
     FIG. 3A is an enlarged, fragmentary, cross-sectional view of the right-hand portion of the device shown in FIG. 3 illustrating the manner of connection of the cover assembly to the base. 
     FIG. 3B is an enlarged, cross-sectional view taken along lines  3 B— 3 B of FIG.  1 . 
     FIG. 3C is an enlarged, cross-sectional view of the area designated as  3 C in FIG.  3 B. 
     FIG. 3D is a greatly enlarged view of an alternate form of distendable membrane and barrier membrane of the invention showing the barrier membrane as a laminate construction. 
     FIG. 4 is a fragmentary, cross-sectional view of the central portion of the device shown in FIG.  3 . 
     FIG. 5 is an enlarged, cross-sectional view of the area designated in FIG. 4 as  5 — 5 . 
     FIG. 6 is a generally perspective, exploded view of the apparatus shown in FIG.  1 . 
     FIG. 7 is a generally perspective, bottom view of the cover sub-assembly shown in FIG.  6 . 
     FIG. 8 is a generally perspective, bottom view of the base sub-assembly shown in FIG.  6 . 
     FIG. 9 is a generally schematic view of one form of the electrical circuitry of the invention. 
     FIG. 9A is a block diagram of the electrical circuitry shown in FIG.  9 . 
     FIG. 10 is a top plan view of an alternate form of the fluid delivery apparatus of the invention. 
     FIG. 11 is a side elevational view of the device shown in FIG.  10 . 
     FIG. 12 is a cross-sectional view taken along lines  12 — 12  of FIG.  10 . 
     FIG. 12A is an enlarged, cross-sectional view similar to FIG. 12 but showing the heat expandable gel expanded. 
     FIG. 12B is an enlarged plan view of the delivery cannula assembly. 
     FIG. 12C is a cross-sectional view taken along lines  12 C— 12 C of FIG.  12 B. 
     FIG. 12D is an enlarged, cross-sectional, exploded view of the assembly shown in FIG.  12 . 
     FIG. 12E is an enlarged, cross-sectional view of the area designated in FIG. 12D as  12 E. 
     FIG. 13 is a cross-sectional view taken along lines  13 — 13  of FIG.  10 . 
     FIG. 13A is an enlarged, cross-sectional view showing the cannula assembly of FIG. 12D connected to the base assembly shown in FIG.  12 D. 
     FIG. 14 is a generally perspective, exploded view of the apparatus shown in FIG.  10 . 
     FIG. 15 is a fragmentary, cross-sectional view of the central portion of the device shown in FIG.  13 . 
     FIG. 16 is an enlarged, cross-sectional view of the area designated in FIG. 15 as  16 — 16 . 
     FIG. 17 is a generally schematic view of another form of the electrical circuitry of the invention. 
     FIG. 17A is a block diagram of the electrical circuitry shown in FIG.  17 . 
     FIG. 18 is a top plan view of an alternate form of the fluid delivery apparatus of the invention. 
     FIG. 19 is a cross-sectional view taken along lines  19 — 19  of FIG.  18 . 
     FIG. 19A is an enlarged, cross-sectional view similar to FIG. 19, but showing the heat expandable member expanded. 
     FIG. 19B is an exploded, cross-sectional view of the device shown in FIG.  19 . 
     FIG. 19C is a view taken along lines  19 C— 19 C of FIG.  19 B. 
     FIG. 20 is a cross-sectional view taken along lines  20 — 20  of FIG.  18 . 
     FIG. 21 is an enlarged, cross-sectional view of the area designated in FIG. 19 as  21 — 21 . 
     FIG. 22 is a generally perspective, exploded view of the apparatus shown in FIG.  18 . 
     FIG. 23 is a fragmentary top plan view of still another form of the fluid delivery apparatus of the invention having a different type of infusion means. 
     FIG. 24 is a cross-sectional view taken along lines  24 — 24  of FIG.  23 . 
     FIG. 25 is a generally perspective fragmentary view of the area of the apparatus shown in FIG.  23 . 
     FIG. 26 is a generally schematic view of another form of the electrical circuitry of the invention. 
     FIG. 26A is a block diagram of the electrical circuitry shown in FIG.  26 . 
     FIG. 27 is a top plan view of yet another alternate form of the fluid delivery apparatus of the invention. 
     FIG. 28 is a left side elevational view of the device shown in FIG.  27 . 
     FIG. 29 is a right side elevational view of the device shown in FIG.  27 . 
     FIG. 30 is a cross-sectional view taken along lines  30 — 30  of FIG.  27 . 
     FIG. 30A is an enlarged, cross-sectional view taken along lines  30 A— 30 A of FIG.  27 . 
     FIG. 30B is a generally perspective, exploded view of the cannula assembly of the device shown in FIG.  30 . 
     FIG. 30C is an enlarged, cross-sectional view similar to FIG. 30, but showing the heat expandable member expanded. 
     FIG. 31 is a generally perspective, exploded view of the apparatus shown in FIG.  27 . 
     FIG. 32 is a generally perspective, bottom view of the cover sub-assembly shown in FIG.  31 . 
     FIG. 33 is a generally perspective view of the device illustrated in FIG. 27 shown interconnected with an external power source. 
     FIG. 33A is an enlarged generally perspective bottom view of the device shown in FIG.  33 . 
     FIG. 33B is an enlarged, cross-sectional view taken along lines  33 B— 33 B of FIG.  33 A. 
     FIG. 34 is a generally schematic view of still another form of the electrical circuitry of the invention. 
     FIG. 34A is a block diagram of the electrical circuitry shown in FIG.  34 . 
     FIG. 35 is a generally perspective view of still another embodiment of the invention which includes a novel controller component for controlling the infusion of beneficial agents to the patient and a novel sensor for sensing metabolic conditions of the patient. 
     FIG. 36 is a generally perspective, diagrammatic view showing the apparatus illustrated in FIG. 35 interconnected with the patient. 
     FIG. 37 is a generally perspective, diagrammatic view of an alternate form of metabolic sensing device connected to the patient&#39;s wrist. 
     FIG. 38 is a block diagram showing the components of the controller and the fluid delivery device shown in FIG.  35 . 
     FIG. 39 is a generally perspective view of yet another embodiment of the invention. 
     FIG. 40 is a top plan view of the base and cover assemblies of the apparatus shown in FIG.  39 . 
     FIG. 41 is a cross-sectional view taken along lines  41 — 41  of FIG.  40 . 
     FIG. 42 is a view taken along lines  42 — 42  of FIG.  41 . 
     FIG. 43 is a top plan view of yet another alternate form of the fluid delivery apparatus of the invention. 
     FIG. 43A is a generally perspective rear view of the device shown in FIG.  43 . 
     FIG. 43B is a generally perspective right-side view of the device shown in FIG.  43 . 
     FIG. 43C is a generally perspective rear view of the device shown in FIG. 43 along with a generally perspective view of a belt clip for receiving the device to enable it to be affixed to the user&#39;s belt. 
     FIG. 44 is rear view of the device shown in FIG.  43 . 
     FIG. 45 is front view of the device shown in FIG.  43 . 
     FIG. 46 is a right side elevational view of the device shown in FIG.  43 . 
     FIG. 47 is a cross-sectional view taken along lines  47 — 47  of FIG.  43 . 
     FIG. 48 is a cross-sectional view taken along lines  47 — 47  of FIG.  43 . 
     FIG. 49 is a cross-sectional view taken along lines  49 — 49  of FIG.  43 . 
     FIG. 50 is a cross-sectional view taken along lines  50 — 50  of FIG.  43 . 
     FIG. 51 is an exploded, cross-sectional view of the apparatus shown in FIG.  49 . 
     FIG. 52 is an exploded, cross-sectional view of the apparatus shown in FIG.  50 . 
     FIG. 53 is an exploded cross-sectional view of a portion of the apparatus shown in FIG. 48 along with a cross-sectional view of the mating delivery line quick disconnect assembly of the invention. 
     FIG. 54 is a generally perspective, top view of the electronics housing of the apparatus shown in FIG.  43 . 
     FIG. 55 is a generally perspective, exploded view of the electronics housing shown in FIG.  54 . 
     FIG. 56 is a generally perspective, bottom view of the fluid reservoir housing of the apparatus shown in FIG.  43 . 
     FIG. 57 is a generally perspective, fragmentary exploded view of the electronics housing and fluid reservoir housing portions of the apparatus shown in FIG.  43 . 
     FIG. 58 is a generally perspective fragmentary view of the components shown in FIG. 57 as they appear in an assembled configuration. 
     FIG. 59 is a fragmentary cross-sectional view showing the construction of the locking mechanism for connecting together the components shown in FIG.  57 . 
     FIG. 60 is a fragmentary, cross-sectional view showing the components illustrated in FIG. 59 in an assembled configuration. 
     FIG. 61 is a generally diagrammatic view showing the various components of the controller and stimulation means of this latest embodiment of the invention. 
    
    
     DESCRIPTION OF THE INVENTION 
     Referring to the drawings and particularly to FIGS. 1 through 9, one form of the apparatus of the invention for use in the infusion of medicinal fluids into a patient is there shown and generally designated by the numeral  30 . As best seen by referring to FIG. 3, the embodiment of the invention here shown comprises a low-profile, fluid storage device  32  which includes an infusion means  34  for infusing the fluid stored in the device into the patient. 
     Turning particularly to FIGS. 3 and 8, it can be seen that fluid storage device  32  includes a base assembly  36  having a central portion  36   a  and peripheral portion  36   b  circumscribing central portion  36   a . Base assembly  36  is provided with a curved lower surface  36   c  which is engagable with the patient when the device is taped or otherwise removably affixed to the patient such as by a pad-like member  38  having adhesive on both sides of the member. 
     Formed within a cover sub-assembly  40 ,which is connected to base  36 , is a generally circular shaped chamber  42  (FIGS.  3  and  4 ), which houses the extremely important expandable means of the invention. This expandable means functions to cause the fluids contained within the sealed reservoir  44  of the device (FIG. 3) to flow outwardly through an outlet  46  formed in base  36  (FIG.  4 ). The heat-expandable means is here provided in the form of a thermal expandable polymer mass  50  which is disposed within chamber  42  in the manner best seen in FIG.  3 . 
     Expandable mass  50  can take several forms, but a particularly attractive form for the delivery devices of the present invention, comprises a semisolid form such as a gel. Unlike liquids, which can offer no permanent resistance to change in shape and must be constrained within some type of container, the gel materials which make up the expandable means of the invention, are of a semisolid form which can advantageously be handled without external containment under ambient manufacturing conditions. By way of example, the gels comprise a cross-linked network of long polymer molecules with liquid molecules trapped within the network. 
     The various phase transition gels best suited for use in constructing the expandable means of the present invention are discussed in detail in incorporated by reference U.S. Pat. No. 5,961,492. Reference should be made to this patent for details concerning gels suitable for the present application which exhibit a large volume change at a given phase-transition condition and which can be made to respond to various types of external stimuli. 
     Turning once again to FIG. 3 of the drawings, it is to be noted that sealing means are superimposed over base  36  to seal chamber  42 . This sealing means here comprises a distendable membrane  52  having an O-ring like periphery  52   a  that is sealably connected to the peripheral portion  36   b  of base  36  in the manner shown in FIG.  3 C. Membrane  52  cooperates with base  36  to form fluid reservoir  44  (FIG.  3 ). It is to be understood that the reservoir-defining cavity can be of any desired geometry. In a manner presently to be described, fill means are provided for introducing fluids into reservoir  44  through a fluid inlet  58  formed in base  36  (FIG.  3 ). As mass  50  is heated, it will controllably expand from the compressed configuration shown in FIG. 3 to an expanded configuration shown in FIG. 3B and, in so doing, will experience a change in volume. Mass  50  can be free standing or, if desired, can be encapsulated within a yieldably deformable covering made up of interconnected membrane layers of the character shown in FIG. 22 of incorporated by reference U.S. Pat. No. 5,961,492. 
     With the construction of the fluid storage device  32  shown in FIG. 3, when the heat expandable mass  50  is heated causing it to expand it will engage sealing membrane  52  which will, in turn, act on an expandable barrier membrane  53  (FIG.  6 ). Membrane  53 , which is disposed within chamber  42 , will then act on the fluid “F” which is contained within the reservoir  44  in a manner to controllably force it outwardly thereof through outlet passageway  46 . As mass  50  expands, it will exert forces on sealing membrane  52  and barrier membrane  53  in a direction toward base  36  resulting in a controlled expelling of fluid from reservoir  44  through fluid outlet  46  and into the infusion means  34  of the apparatus, the details of construction, which will presently be described. If desired, medicament and instruction labels can be affixed to cover  40  to identify the medicinal fluid contained within reservoir  44  of the device. 
     For a discussion of the various materials that can be used to construct base  36 , cover  40 , and membrane  52 , reference should be made to U.S. Pat. No. 5,205,820. This patent also discusses in greater detail techniques for labeling and venting of the fluid storage device where necessary. It should be noted that barrier membrane  53  can be of a single layer or multiple layer construction with one of the layers such as layer  53   a  comprising a thermal barrier (see FIG.  3 D). Thermal barrier layer  53   a  can be formed from various materials including a polyurethane foam material sold under the name and style Poron® by Rogers Corporation of Rogers, Conn.; silicone rubber or foam also sold by Rogers Corporation; and a polyethylene naphthalate (PEN) sold by Amoco Chemicals Co. It should also be understood that a barrier layer  52   b  may also be provided to overlay membrane  52  and can function as either a chemical barrier or as a thermal barrier. 
     Forming a unique aspect of the apparatus of the present invention is the stimulation means for controllably heating expandable mass  50 . As best seen in FIGS. 6 and 7, this stimulation means here comprises a flat printed circuit heater element  60 , a battery  62  for heating element  60  and an operating chip  64  (FIGS. 7,  9  and  9 A), which comprises the control circuit of the apparatus for operably interconnecting the heating element with the battery. As shown in FIG. 3, flat circuit heater element  60  is disposed within chamber  42  and is located between expandable mass  50  and the upper surface  42   a  of chamber  42 . In operation, when heater element  60  is energized by operation of a membrane switch  67  (FIG. 7) it will generate heat sufficient to cause expandable mass  50  to force membrane  52  downwardly toward base  36  in the manner shown in FIG. 3B causing the fluid “F” to controllably flow through outlet  46  in a direction toward the infusion means  34 . The heater element leads  60   a  (FIG. 6) are interconnected with battery  62  via the operating chip  64  and the membrane switch  67  in a manner well understood by those skilled in the art. Referring to FIGS. 9 and 9A, one form of the electrical circuitry of the heating means of the invention is there shown illustrating the manner of inter-connection of the various components that make up the stimulation means. Also forming a part of the stimulation means of the invention are indicator means for indicating energization and deenergization of the heater element. These indicator means here comprise red and green light emitting diodes  71  and  73  respectfully, which diodes are carried by cover  40  in the manner indicated in FIG.  6 . Also comprising a part of the indicator means of the invention is an audio horn  74  which is suitably interconnected with battery  62  and chip  64  and functions to emit an audio signal when the reservoir of the device is empty (see also FIG.  9 ). 
     Turning particularly to FIGS. and  9  and  9 A, the electrical circuitry of the apparatus can be seen to comprise a power source, shown here as battery  62  which, via switch  67 , controls current flow to a control circuit which comprises the earlier identified chip  64 . Operably interconnected with the control circuit is the previously identified foil heater  60 , a heat sensor  61  for sensing the temperature of the foil heater, the visual indicators, or red and green light emitting diodes  71  and  73  and the audio horn  74 . 
     As best seen in FIGS. 3,  3 B and  6 , the infusion means of the invention here comprises a uniquely configured hollow cannula  77 . Cannula  77  includes a circuitously shaped body portion  77   a  which is disposed within a chamber  79  formed within a base insert  36   d  which comprises a part of base assembly  36 . Cannula  77  also includes an outlet end here provided in the form of a needle-like segment  77   b  (FIG. 3B) which extends generally perpendicularly downward from the lower surface of the base and is used for subdermal infusion of medicinal fluids into the patient. For this purpose, segment  77   b  is provided with a sharp ground needlepointed extremity  77   c  (FIGS.  3  and  3 B). Also shown in FIG. 3 is a twist-off protective sheath  80 , which forms a part of base insert  36   d . Sheath  80  surrounds and protects extremity  77   c  of the cannula. The body portion of the very small diameter spiral cannula  77  is rigidly supported within base insert  36   d  by encapsulation means such as a standard potting compound “P” (FIG. 3C) of a character well known to those skilled in the art. 
     As best seen in FIGS. 4 and 5, the inlet  77   d  of cannula  77  is in fluid communication with reservoir  44  via the novel flow control means of the invention which is shown here as flow control assembly  84 . Flow control assembly  84  comprises a rate control or impedance member  86  that is held in position within outlet  46  by an elastomer molded ring  88 . Member  86  can be constructed from a porous ceramic, a plastic, a sintered metal or other suitable materials which will control the rate of fluid flow toward cannula  77 . 
     While cannulas of conventional construction can be used as the infusion means, a novel feature of the present invention relates to the novel design of the circuitously shaped cannula and the unique manner of its interconnection with base  36 . More particularly, with the novel construction shown in the drawings, when the device is connected to the patient the needle portion  77   c  of the cannula penetrates the patient&#39;s skin and tissue as, for example, that found on the patient&#39;s arm, leg, or abdomen, while the body portion thereof is securely held in position within base insert  36   d.    
     In using the apparatus of the present invention, reservoir  44  is first filled with the beneficial agent to be infused into the patient. This is accomplished through use of the fill means of the invention, which here comprises a non-coring, elastomeric septum  90 . As shown in FIG. 6, septum  90  is securely held in position within base  36  by a clamping ring  92 , which is, in turn affixed to base  36 . Septum  90  is of standard construction and is penetrable by a cannula of a filling syringe of conventional construction. The conventional syringe (not shown) can be used to introduce the fluid to be dispensed to the patient into inlet passageway  58  and thence into reservoir  44 . It is to be understood, however, that reservoir  44  can also be filled at the factory at the time of manufacture of the fluid storage device. Alternatively, the reservoir can be filled in the field shortly before use by means of the conventional syringe. 
     With reservoir  44  filled in the manner shown in FIGS. 3 and 4 of the drawings, protective sheath  80  is slipped from the end of cannula. With end  77   c  of cannula  77  thus exposed, the infusion device can be interconnected with the patient by penetrating the patient&#39;s skin with the sharp point  77   c  of the infusion cannula. As the infusion needle penetrates the patient&#39;s skin and tissue, the lower surface of base  36 , which is preferably coated with an adhesive, or a suitable adhesive coated pad, will engage the patient&#39;s skin so as to hold the device securely in position. If desired, a peelable cover can be emplaced over a portion of the lower surface of the device to maintain the adhesive in an aseptic condition until time of use. 
     When the device is suitably affixed to the patient&#39;s body, such as to an arm, leg, or abdomen, energization of heating element  60  will cause heat expandable mass  50  to expand in the manner shown in FIG. 3B thereby causing the fluid “F” contained within reservoir  44  to controllably flow under pressure toward outlet passageway  46 . For this purpose, mass  50  should controllably expand within a temperature range in excess of normal body temperature. The fluid “F” entering outlet passageway  46  will flow through a fluid flow control means and into inlet  77   d  of cannula  77  (FIG.  4 ). 
     Turning to FIGS. 10 through 17, an alternate form of the apparatus of the invention for use in the infusion of medicinal fluids into a patient is there shown and generally designated by the numeral  100 . This alternate embodiment is similar in many respects to that shown in FIGS. 1 through 9 and like numerals are used in FIGS. 10 through 16 to identify like components. As best seen by referring to FIGS. 12 and 14, the apparatus here comprises a low-profile device  102  for infusing fluid contained within the device into the patient. While the base assembly, the fill means and the infusion means of the invention are substantially identical to that previously described in connection with FIGS. 1 through 9, the stimulation means is of a somewhat different construction. More specifically, the stimulation means here comprises a heater means which includes a foil heater  104  and the circuitry which controls the heater. As shown in FIGS. 14,  17  and  17 A, this circuitry includes a dome switch subassembly  106  that is mounted within an electronics cover  108  that forms a part of the cover sub-assembly  110  of this latest embodiment of the invention. 
     Formed within cover  112  of cover sub-assembly  110 , which is connected to base  36 , is a generally circular shaped chamber  114  (FIGS.  12  and  13 ), which houses the earlier described heat-expandable means of the invention. As before, the stimulation means functions to act upon the expandable gel in a manner to cause the fluids contained within the sealed reservoir  44  of the device (FIG. 12) to flow outwardly through an outlet  46  formed in base  36  The expandable gel, or thermal expandable polymer mass  50 , functions to controllably force the fluids contained within the sealed reservoir  44  of the device to flow outwardly through the previously identified outlet  46  formed in base  36 . The expandable gel is of the character previously described herein and is covered by a sealing means comprising membrane  52  which is sealably connected to the peripheral portion  36   b  of base  36  in the manner indicated in FIGS. 12 and 12A. However, as illustrated in FIG. 12, the heat expandable gel is here mounted within a porous gas vent ring  75  that functions during the reservoir filling step to vent chamber  42  via a porous plug vent “V”. Fill means of the same character described in connection with the first embodiment of the invention are provided for introducing fluids into reservoir  44  through fluid inlet  58  formed in base  36 . 
     As best seen in FIGS. 12,  14 ,  17  and  17 A, the heating means here comprises the previously identified foil heater element  104 , a power source or battery  116  for heating element  104  and an electronics mounting board  118  which carries battery  116  as well as an audio horn  120 . As shown in FIG. 12, heater element  104  is disposed within chamber  42  and is located between expandable mass  50  and the upper surface  114   a  of chamber  114 . In operation, when heater element  104  is energized by operation of the dome switch  106   a  of switch assembly  106  by pressing on the flexible switch cover  106   b  (FIG. 12) it will generate heat sufficient to cause expandable mass  50  to force membranes  52  and  53  downwardly toward base  36  causing the fluid “F” to controllably flow throughout outlet  46  in a direction toward the infusion means  34 . The heater element leads  104   a  (FIG. 14) are interconnected with battery  116  and with switch  106   a  and with a light-emitting diode or indicator  107  in a manner well understood by those skilled in the art. More particularly, referring to FIGS. 17 and 17A, the electrical circuitry of the heating means of this latest form of the the invention is there shown indicating the manner of inter-connection of the various components that make up the heating means. The indicator means of this latest embodiment comprise the previously identified diode  107  and the audio horn  120  which is suitably interconnected with battery  116  and functions to emit an audio signal when the reservoir of the device is empty. 
     As indicated in FIGS. 17 and 17A, the electrical circuitry of this latest form of the apparatus comprises a power source, shown here as battery  116  which, via switch  106  controls current flow from the power source to the foil heater  104 . The light emitting diode  107  is interconnected between the switch  106  and the foil heater  104  in the manner shown in FIGS. 17 and 17A. 
     As illustrated in FIGS. 12B and 12C, the infusion means of this latest form of the invention is similar to that previously described and includes a base insert  36   d  that houses the circuitous cannula  77  and is interconnectable with the base of the delivery device in the manner shown in FIGS. 12 and 13. 
     In using the apparatus of this latest form of the invention, reservoir  44  is filled in the manner previously described through use of the fill means of the invention, which comprises a non-coring elastomeric septum  90  (FIG.  12 ). As before, reservoir  44  can be filled at the factory at the time of manufacture of the fluid storage device or it can be filled in the field shortly before use by means of a conventional syringe. 
     With reservoir  44  filled in the manner shown in FIGS. 12 and 13 of the drawings, protective sheath  80  is slipped from end of cannula and the device is interconnected with the patient by penetrating the patient&#39;s skin with the sharp point  77   c  of the infusion cannula. 
     With the device affixed to the patient&#39;s body, energization of heating element  104  will cause heat expandable mass  50  to expand in the manner shown in FIG. 12A thereby causing the fluid “F” contained within reservoir  44  to controllably flow under pressure toward outlet passageway  46  via the flow control means of the device which is of the character previously described. 
     Turning to FIGS. 18 through 22, another form of the apparatus of the invention for use in the infusion of medicinal fluids into a patient is there shown and generally designated by the numeral  130 . This latest embodiment is also similar in many respects to that shown in FIGS. 1 through 9 and like numerals are used in FIGS. 18 through 22 to identify like components. As before, the apparatus here comprises a low-profile device for infusing fluid contained within the device into the patient. While the fill means and the infusion means of the invention are substantially identical to that previously described in connection with FIGS. 1 through 9, the base and cover assemblies are of a somewhat different construction and are adapted to removably support a different type of battery. More specifically, the base component  132  here includes a side extension  132   a  which, in conjunction with a side extension  134   a  of a cover assembly  134 , forms a generally cylindrical shaped battery receiving chamber  136  (FIG. 19) for receiving a high performance battery  140  such as a lithium or mercury battery. Battery  140  comprises a part of the heating means of this latest form of the invention, which also comprises the previously described flat printed circuit heater element  60 . 
     As shown in FIG. 19, flat circuit heater element  60  is disposed within a chamber  142  formed in cover  134  and is located between expandable mass  50  and the upper surface  134   b  of chamber  142 . In operation, after the reservoir has been filled using the fill means, the heater element  60  can be energized by operation of a dome switch  146  mounted proximate one end of chamber  136  (FIG.  18 ). Dome switch  146  can be off, on or intermittent depending upon the end use application of the device. Upon being energized, the heating element will generate heat sufficient to cause expandable mass  50  to force membranes  52  and  53  downwardly toward base  132  causing the fluid “F” to controllably flow through an outlet  147  formed in base  132  in a direction toward the infusion means  34 . 
     The heater element leads  60   a  of the heater element (FIG. 22) are interconnected with battery  140  and with dome switch  146  (FIG. 18) in the manner shown in FIGS. 26 and 26A. Also forming a part of the heating means of this latest form of the invention are indicator means for indicating energization and deenergization of the heater element. This indicator means here comprises a light emitting diode  149  that is carried by cover  134  in the manner illustrated in FIG.  22 . 
     An important aspect of the apparatus of this latter form of the invention is the previously discussed infusion means or assembly  34 . Assembly  34 , which comprises a subcutaneous infusion device, is of identical construction to that previously described and functions in an identical manner. 
     Turning to FIGS. 23 through 25, yet another form of the apparatus of the invention is there shown and generally designated by the numeral  156 . This latest embodiment is similar in many respects to that shown in FIGS. 18 through 21 and like numerals are used in FIGS. 23 through 25 to identify like components. While the cover assembly, the fill means and the heating means of the invention are substantially identical to that previously described in connection with FIGS. 18 through 21, the base assembly  160  and the infusion means are of a somewhat different construction. More particularly, the infusion means here comprises a novel administration set  158  that is connected to base  162  of base assembly  160  in the manner best seen in FIGS. 23 and 25. 
     As shown in FIGS. 23,  24  and  25 , the base assembly  160  also includes an outlet passageway  163  that communicates with reservoir  44  and with an externally accessible luer connector  164 . Luer connector  164  enables quick interconnection of the infusion means with base assembly  160  so that the delivery tube or administration line  158   a  of the administration set  158  is placed in fluid communication with fluid passageway  163 . Forming a unique aspect of the administration set is the remotely located subcutaneous infusion device  165 , which is provided at the distal end of line  158   a  (FIG.  25 ). This device is similar in construction and operation to device  83  shown in FIG. 16 of incorporated by reference U.S. Pat. No. 5,961,492 and includes a base  166  that supports a generally dome-shaped cover  168 . Cover  168  defines a chamber  95 , which houses the body portion of a hollow cannula  170  of the invention. Cannula  170  includes a needle-like segment which extends generally perpendicularly downward from base  166  and is used for subdermal infusion of medicinal fluids into the patient. Reference should be made to U.S. Pat. No. 5,961,492 for a more detailed description of infusion device  165 . Provided at the proximal end of line  158  is a luer connector  173  that can be mated with luer connector  164  to sealably connect the administration set with base  162 . 
     With the construction thus described, after the reservoir has been filled using the fill means, the heater element  60  can be energized by operation of a dome switch  146  mounted proximate one end of chamber  142  (FIG.  18 ). Upon being energized, the heating element will generate heat sufficient to cause expandable mass  50  to force membranes  52  and  53  downwardly toward base  160  causing the fluid “F” to controllably flow through an outlet  147  formed in base  132  (FIG. 24) then into passageway  163  and finally into the infusion means of this latest form of the invention. After the infusion device  165  has been connected to the patient in the manner discussed in incorporated by reference U.S. Pat. No. 5,961,492, the fluid will controllably flow into the patient via the flow control means of the invention. 
     The heater element leads  60   a  of the heater element (FIG. 22) are interconnected with battery  140  and with dome switch  146  in the manner indicated in FIGS. 26 and 26A. Also forming a part of the heating means of this latest form of the invention are indicator means for indicating energization and deenergization of the heater element. This indicator means here comprises a light emitting diode  149  that is carried by cover  134  in the manner illustrated in FIG.  22  and is interconnected with the foil heater in the manner indicated in FIGS. 26 and 26A. 
     Turning next to FIGS. 27 through 33, yet another form of the apparatus of the invention for use in the infusion of medicinal fluids into a patient is there shown and generally designated by the numeral  180 . This latest embodiment is also similar in many respects to that shown in FIGS. 1 through 9 and like numerals are used in FIGS. 27 through 33 to identify like components. While the base, the fill means and the infusion means of the invention are once again substantially identical to that previously described in connection with FIGS. 1 through 9, the cover assembly is of a somewhat different construction and is adapted to provide a port  182  for housing an electrical connection means in the form of a multi-pin electrical interconnection  184  (FIG. 27) to enable the delivery device to be interconnected with an external power source. 
     As best seen in FIG. 30, the cover component  186  here includes a side extension which defines port  182  and a generally cylindrical shaped chamber  188  for receiving the previously described flat printed circuit heater element  60 . As shown in FIG. 30, flat circuit heater element  60  is once again located between expandable mass  50  and the upper surface  188   a  of chamber  188 . 
     In operation, after the reservoir has been filled using the fill means and the power source “S” has been connected to connector  184  using female connector  190  (FIG.  33 ),the heater element  60  can be energized by operation of a conventional switch  192  that is disposed within an electrical line  194  which interconnects the power source “S” with female connector  190 . Power source “S” can comprise a battery pack, an AC/DC converter, or other type of power source known to those skilled in the art. Upon being energized, the heating element will generate heat sufficient to cause expandable mass  50  to force membranes  52  and  53  downwardly toward base  185  causing the fluid “F” to controllably flow through an outlet  46  formed in base  185  via flow control element  86  in a direction toward the infusion means  34 . The heater element leads  60   a  of the heater element (FIG. 31) are interconnected with power source “S” and with switch  192  in the manner shown in FIGS. 34 and 34A. 
     Turning to FIGS. 35 through 37, still another form of the apparatus of the invention for use in the infusion of medicinal fluids into a patient is there shown and generally designated by the numeral  200 . This latest embodiment is similar in many respects to that just described and shown in FIGS. 27 through 34 and like numerals are used to identify like components. While the base, fill means and infusion means of the invention are substantially identical to that previously described in connection with FIGS. 27 through 34, the power supply and infusion means are of a different construction. More specifically, the power supply comprises a novel belt mounted power supply and electronic controller  202  the character of which will presently be described. As best seen in FIGS. 35 and 38, controller  202  is electrically connected to cover  186  by female connector  190  and an electrical conduit  206 . Female connector  190  mates with connector  184  in the manner previously described. 
     As indicated in FIGS. 35 and 36, controller  202  can be connected to the patient&#39;s belt or other article of clothing and is, in turn, connected to a sensor  210  by a conduit  212 . The nature and purpose of sensor  210  will be discussed presently. As best seen by referring to FIGS. 35 and 38, controller  202  includes a housing  214  that houses the various operating components shown in FIG. 38, which comprise a main control unit  216  having a memory  218 , manual programming interface switches  220 , a conventional power source  222  and a power switch  224  (FIG.  38 ). Connected to main control unit  216  is a visual indicator  226 , a data display  228  and an audible horn  230 . Also connected to main control unit  216  is a download port  232 , a physician&#39;s key  234  and a real time clock  236 . 
     Referring also to FIG. 35, it can be seen that the delivery device, which includes base  185 , cover  186  and heater  60  is connected to the patient in the manner previously described and as illustrated in FIG.  36 . Located on the top of the controller  202  is a navigation keypad  240  and a function keypad  241 . 
     In operation of the apparatus of this latest embodiment of the invention, the electronic controller can be programmed by a health care provider using an assigned physician&#39;s key and the various controls located on the controller to select the desired functions which can be displayed on the data display. By way of example, the controller can be programmed in a manner well known to those skilled in the art to precisely deliver basal, elevated basal, bolus and varying dosing volumes in response to either physiological sensor  210  or to a pre-programmed delivery protocol. In this regard, the various delivery levels can be achieved by selectively varying the power supplied to the delivery heater as, for example, by changing the voltage or current levels, by changing the pulse width modulation of the applied power, or by changing the frequency, amplitude or pulse amplitude modulation of the applied power. The electronic controller can also be programmed to monitor the heat sensor  244  of the delivery device (FIG. 38) to verify the desired delivery performance of the device and to detect the highly unlikely event of a thermal runaway failure of the heater. The user will be notified of any heater malfunction by the audio alarm or audible horn  230 . 
     After the electronic controller is initially programmed, function keypads  241 , which are operably associated with switches  220 , can be used to select a different delivery schedule. If desired, once the unit is programmed, the controller can be locked using the physician&#39;s key thereby preventing any unauthorized user changes to the settings. 
     While the unit is operating, data display  228  will display information concerning the current basal and bolus settings, total drug amount delivery, time or dosage remaining or other information determined to be needed. Physiological sensor information could also be displayed, and downloaded to a compatible system to allow analysis of the physiological sensor data at a later time. In this regard, the previously identified physiological sensor  210  can comprise a glucose sensor of the general character developed by Minimed, Inc. of Sylmar, Calif. and Integ, Inc. of St. Paul, Minn. These devices, which may be affixed to the patient&#39;s abdomen as shown in FIG. 36, uses a small sampling cannula which is inserted into the tissue of the patient. Referring to FIG. 37, an alternate, wristmounted sensor  210   a  can also be used. This sensor may comprise a patch type sensor of the type developed by Cygins, Inc. of San Diego, Calif., or TCPI of Pompano Beach, Fla., or a sensor that can sample interstirial fluids. 
     Turning next to FIGS. 39 through 42, yet another form of the apparatus of the invention for use in the infusion of medicinal fluids into a patient is there shown. This latest embodiment is similar in many respects to that just described and shown in FIGS. 35 through 38 and like numerals are used to identify like components. While the cover, the heating means and fill means the invention are substantially identical to that previously described in connection with FIGS. 35 through 38, the infusion means are of a different construction. More specifically, the infusion means includes an infusion device  165  that is identical to that shown in FIG.  25 . However, the infusion device is here connected to a slightly differently configured base component  242  by a novel quick connect assembly  244 . As before, the power supply comprises a part of the novel belt mounted, electronic controller  202  which is of the character previously described. 
     As best seen in FIGS. 39 and 41, base  242  includes a tapered chamber  246  (FIG. 41) that communicates with reservoir  44  via an outlet passageway  248 . Quick connect assembly  244  here includes a body portion  250  having a tapered forward portion  250   a  that is sealably received within chamber  246  in the manner shown in FIG.  41 . Body portion  250  also includes a centrally disposed, outwardly extending finger  250   b  which is either connected to, or alternatively is integrally formed with, an operating lever arm  250   c  to form a living hinge type construction. Formed proximate the inboard end of lever arm  250   c  is a locking tooth  250   d  which lockably engages an upwardly extending, generally “U” shaped member  252  that is provided on base component  242  (FIGS.  39  and  42 ). With this construction, an inward force imposed on the outboard end of arm  250   c  will cause locking tooth  250   d  to swing away from member  252  a sufficient distance to permit withdrawal of body portion  250   a  from chamber  246  so as to enable separation of the infusion device  165  from base  242 . 
     In operating the apparatus of this latest form of the invention, after the reservoir  44  has been filled using the previously described fill means, the infusion device  165  can be interconnected with base  242  through appropriate manipulation of the quick connect mechanism. This done, the device can be interconnected with the patient and the heating element  60  be energized using the controller  202 . The elevated temperature of the heating element will cause heat expandable mass  50  to increase in volume causing the fluid contained within reservoir  44  to controllably flow under pressure toward outlet passageway  248 . The fluid will then flow through the central passageway  250   e  of body  250  , through a line  254  and into infusion device  165  for controlled delivery to the patient (FIG.  39 ). 
     Referring next to FIGS. 43 through 60, still another form of the apparatus of the invention is there shown and generally designated by the numeral  260 . This alternate embodiment is quite different from those previously described in that the heating means and the fluid housing are discrete components that can be snapped together to form the dispensing device of the invention. More particularly, as best seen in FIGS. 51 and 52, the apparatus here comprises a disposable upper reservoir component  262  and a re-usable lower electronics component  264 . Referring also to FIG. 56, it can be seen that reservoir component  262  includes a cover  266  having a generally circular shaped chamber  268  which houses the heat-expandable means of the invention. As before, the heat expandable means functions to cause the fluids contained within the sealed reservoir of the device to flow outwardly through an outlet  270  formed in cover  266  (FIG.  43 ). The heat-expandable means is here provided in the form of a thermal expandable polymer mass  272  which is disposed within chamber  268  in the manner best seen in FIGS. 51 and 52. Once again expandable mass  272  can take several forms, but a particularly attractive form for devices of the present invention comprises a semisolid form such as a gel. 
     As in the earlier described embodiments, sealing means are superimposed over chamber  268 . This sealing means here comprises a distendable membrane  274  having an O-ring like periphery  274   a  that is sealably connected to the peripheral portion of cover  266  in the manner shown in FIGS. 51 and 52. Membrane  274  cooperates with cover  266  to form a fluid reservoir that can be filled with the fluid to be dispensed by novel fill means of a character presently to be described. As mass  272  is heated by a heater coil  275 , which is housed within lower electronics component  264 , it will controllably expand from a compressed configuration to an expanded configuration and, in so doing, will experience a change in volume. With the construction of the device  260  shown in FIGS. 49 and 50, when the reservoir is filled heat expandable mass will be compressed by a gel barrier membrane  277  which spans chamber  268  and engages membrane  274 . Then, as the heat expandable means is heated by the heating means of the invention, it will controllably expand against membrane  277  which will, in turn, act on the fluid which is contained within the reservoir in a manner to controllably force it outwardly thereof through outlet passageway  270  and into the infusion means of the apparatus, the details of construction which will presently be described. 
     As best seen in FIGS. 51,  52  and  55 , the re-usable electronics component  264  includes a base member  264   a  and an electronics housing  264   b , which is connected thereto. Base member  264   a  is apertured to receive a heater assembly frame  281  that is provided with a first chamber  280   a . Chamber  280   a  houses heater coil  275  as well as a ceramic thermal barrier  282  that is supported by a conventional potting compound  284  that is contained within a second, lower chamber  280   b  formed in heater assembly frame  280 . 
     Electronics housing  264   b  includes a chamber  288  which can be closed by a cover  289  and which houses the power supply, here provided as a high performance battery  290 . Electronics housing  264   b  also houses the electronic control module  292  of the device, the character of which will presently be described. As will later be discussed, module  292  can be programmed by means of the electronic programming buttons  294  carried by housing  264   b  (FIG.  44 ). 
     Superimposed over base member  264   a  is a locking plate  296 , which comprises part of the component connector means of the invention, and which functions to releasably interconnect reservoir component  262  with electronics component  264  in the manner shown in FIGS. 43A and 43B. Locking plate  296 , which includes opposed operating springs  298 , the purpose of which will presently be described, is held in position by a retainer plate  300  which overlays base member  264   a  in the manner shown in FIGS. 51 and 52. As shown in FIG. 55, locking plate  296  includes a generally oval shaped central clearance opening  296   a  and four generally keyhole-shaped openings  302 , each of which has an enlarged diameter portion  302   a . Portions  302   a  can be moved into index with one of four bores  304  formed in base member  264   a  and with one of four apertures  306  formed in retainer plate  300  by pushing locking plate  296  inwardly against the urging of springs  298 . More particularly, as illustrated in FIG. 59, by pushing inwardly on a push pad  308  provided at the edge of plate  296 , the enlarged diameter portions  302   a  of keyhole-shaped openings  302  will move into index with bores  304  and with apertures  306 . However, as shown in FIG. 60, when pressure on push pad  308  is released, springs  298 , which are positioned within openings  310  of base member  264   a , will urge locking plate  296  to the right as shown in FIG. 60, causing the neck portions  302   b  of openings  302  to move into index with bores  304  and apertures  306 . 
     With the construction described in the preceding paragraph, when push pad  308  has been pushed inwardly into slot  314  of base member  264   a  (FIG.  59 ), connector pins  312  provided on the reservoir component can be freely inserted into apertures  306 , past locking plate  296  and into bores  304  of base member  264   a . Once the pins are fully seated within bore  304 , a release of pressure on push pad  308  will cause springs  298  to urge locking plate  296  into the position shown in FIG.  60 . In this position, the edges of the necked down portions  302   b  of the keyhole-shaped openings  302  will reside within grooves  312   a  formed in connector pins  312  thereby locking together reservoir component  262  and electronics component  264 . When desired, the components can be separated by pushing inwardly on push pad  308  to move enlarged diameter portions  302   a  into index with bores  304  and apertures  306 . 
     When the reservoir and electronic component  262  and  264  have been connected in the manner shown in FIGS. 43A,  43 B,  49  and  50 , energization of heater coil  275 , in the manner previously described, will controllably expand mass  272  urging the fluid to be dispensed to the patient outwardly of the device reservoir which is formed by distendable membrane  274  upon filling the dispensing device using the reservoir fill means of the invention. 
     Considering next the novel reservoir fill means of the invention, this means here comprises three major components, namely a side housing  266   a  connected to cover  262 , the previously mentioned medicament vial cartridge or container assembly  280  and an adapter or pusher sleeve assembly  316  (FIGS.  47  and  56 ). Container assembly  280  contains the medicinal fluid with which the reservoir of the dispensing device is to be filled. As best seen in FIG. 47, container assembly  280  includes a chamber  318  having first and second open ends. The first open end is sealably closed by closure means, here provided in the form of septum assembly  320  which includes a pierceable septum and a clamping ring for connecting the septum to the container proximate the first open end. The septum of the septum assembly  320  is pierceable by a cannula means or cannula  322  which is carried by side housing  266   a.    
     Referring next to FIGS. 49 through 52 it is to be noted that cover  266  may be constructed of a plastic material such as, for example, a polycarbonate, an acrylic polystyrene, polyvinylchloride, polyethylene, polyester, PMMA, polysulfone, polyurethane, polyinuide, polyvinylalcohol, polypropylene. With this construction, the interior surface of the cover  266  as well as fluid flow passageways which carry fluid to the infusion means can be surface modified or coated with various materials to form thin conformable, protective, interfacial barriers “B” for biological compatibility or to promote wetlubricity or wettability. 
     These barriers or surface treatments “B” can include hydrophilic agents that offer a wide range of wettability characteristics which can be tailored to meet the required surface wetting, priming, reduction of gas bubble adhesion, and other flow performance characteristics. Other forms of these coatings can also reduce the absorption and denaturation of other biomaterials, including proteins. Alternatively, modified proteins, peptides, carbohydrates and synthetic polymers can also be covalently bonded to surfaces to generate ultrathin coatings or crosslinked to generate other three dimensional intermediate polymer matrices to either inhibit other biochemical responses or for immobilization of related biomaterials. These coatings and surface modification treatments are readily available from multiple sources and well known to those skilled in the art. 
     To expel fluid from chamber  318  of the container assembly and into cannula  322  and thence into the fluid reservoir of the dispenser unit via passageways  333  and  270 , displacement means are provided. This displacement means here comprises a plunger  324  which is telescopically movable within chamber  318  by pusher sleeve assembly  316 . To accomplish this movement, pusher sleeve assembly  316  is provided with pusher means shown here as a pusher rod  326  which is integrally formed with end wall  316   a  of the pusher sleeve assembly (FIG.  47 ). 
     Referring particularly to FIGS. 47 and 56, it is to be noted that side housing  266   a  includes an inner, generally cylindrically shaped wall  327  which defines an elongated annular space  329  within which the pusher sleeve assembly  316  is slidably received. As shown in FIGS. 47 to  56 , container assembly  280  is closely receivable within a chamber  331  formed internally of wall  327  and can be urged forwardly of chamber  331  by inward telescopic movement of the pusher sleeve assembly into annular space  329 . More particularly, as indicated in FIG. 47, the inboard end of pusher rod  326  engages plunger  324  and urges it inwardly of chamber  318  as the pusher sleeve is moved inwardly of annular space  329 . 
     During the initial mating of the pusher sleeve assembly and the container assembly with side housing  266   a , the resistance of the fluid within chamber  318  will resist movement of plunger  324  inwardly of chamber  318  so as to cause the entire container assembly to initially move inwardly of chamber  331  to a position wherein the septum assembly  320  is engaged by cannula  322  of the side housing. A continued inward force on the pusher sleeve assembly will cause cannula  322  to pierce the septum in the manner shown in FIG. 47, thereby opening fluid communication between chamber  318  of the container assembly and the internal fluid passageway of cannula  322 . Once the septum has been pierced, pusher rod  326  will urge plunger  324  forwardly of chamber  318  from a first location proximate the second open end to the second location shown in FIG.  47 . As plunger  324  moves forwardly of chamber  318 , fluid within the chamber will be caused to flow into the central fluid passageway of cannula  322  toward a passageway  333  formed in cover  266   b  and finally into the device reservoir via passageway  270  (FIG.  43 ). 
     It is to be noted that the pusher sleeve assembly includes a plurality of longitudinally spaced locking teeth  316   b  which are engaged by a locking tab  267  provided on a clip-like member  267   a  that is mounted within a space  329   a . As the pusher sleeve assembly is urged into annular space  329   a , tab  267  will ride over teeth  316   b . However, teeth  316   b  are configured to prevent attempted removal of the pusher sleeve thereby preventing re-use of the fill means. 
     Following filling of the reservoir of the device with the fluid to be infused into the patient, the novel infusion means of the invention, which includes line connector  320 , is connected to reservoir component  262  in the manner shown in FIGS. 43A and 43B. As indicated in FIG. 53, line connector  320  includes a body  322  having a fluid passageway  324  therethrough. Connected to the outboard end of passageway  324  is a conventional administration set delivery line  326 . The forward portion of body  322  is sealably received within a tapered bore  328  formed in a connector block  330 . Connector block  330  is, in turn, received within a cavity  332  formed in a second side housing  266   b  that is connected to cover  266 . Cavity  332  is in communication with the reservoir of the device via passageways  333  and  270  (FIGS.  50  and  53 ). When connector block  330  is in position within cavity  332 , passageway  333  is also in communication with passageway  338  formed in connector block  330  via the flow control means of the device. This flow control means here comprises a porous impedance frit  340  which functions to controllably impede or modulate fluid flow toward line  326  in the event of any unexpected environmental perterbation and during the reservoir filling step. Body  322  of line connector  320  further includes a resilient tab  322   a  which is engaged by a release button  342  that releasably secures the line connector in position within the connector block. 
     In operation of the apparatus of this latest embodiment of the invention, after the reservoir has been filled and the infusion means connected in the manner just described, the electronic controller and storage module of the device can be programmed to enable the precise delivery of basal, elevated basal, bolus and varying dosing volumes in response to either a physiological sensor of the character previously described or to a programmed delivery protocol. As was the case with the embodiment shown in FIGS. 35 through 38, the various delivery levels can be achieved by selectively varying the power supplied to the delivery heater as, for example, by changing the voltage or current levels, by changing the pulse width modulation of the applied power, or by changing the frequency, amplitude or pulse amplitude modulation of the applied power. The electronic controller can also be programmed to indicate function status to the user and to detect the highly unlikely event of a thermal runaway failure of the heater. The user will be notified of any heater malfunction by the audio alarm or audible horn  23  (see FIG.  61 ). 
     Referring particularly to FIG. 61, it can be seen that the electronic controller module  292  comprises a main control unit  346  having a memory  348 , manual programming interface switches  350 , a conventional power source  352  and a power switch  354 . Connected to main control unit  346  is a data display shown here as a backlit LCD display  356  and an audible horn  358 . Also connected to main control unit  346  is a download port  359 , a physician&#39;s interface  360  and a real time clock  362 . Additionally, the main control unit is connected to the heater or heater coil  275  and to a heat sensor  364  in the manner shown in FIG.  61 . After the electronic controller and storage means are initially programmed, programming buttons  299  (FIG.  44 ), which are operably associated with switches  350 , can be used to select a different delivery schedule. If desired, once the unit is programmed, the controller can be locked using the physician&#39;s interface thereby preventing any changes to the settings by an unauthorized person. It is to be understood that electronic controller  292 , as well as the earlier described controller  202  can readily be programmed by one skilled in the art to perform the aforementioned functions as well as other functions that may be desired by the physician. 
     While the unit is operating, data display  356  will display information concerning the current basal and bolus settings, total drug amount delivery, time or dosage remaining or other information determined to be needed such as battery charge level and the like. Physiological sensor information from sensors of the character previously identified can also be displayed, and downloaded to a compatible system to allow analysis of the physiological sensor date at a later time. After the device has been programmed, it can be inserted into a belt clip  345  of the character shown in FIG. 43 c  and then attached to the user&#39;s belt. 
     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.