Abstract:
A compact fluid dispenser for use in controllably dispensing fluid medicaments, such as antibiotics, blood clotting agents, analgesics, and like medicinal agents from collapsible containers at a uniform rate. The dispenser includes a novel stored energy source that is provided in the form of a compressible-expandable member that functions to continuously and uniformly expel fluid from the apparatus reservoir. The apparatus further includes a novel fluid flow control assembly that precisely controls the flow of the medicament solutions from the apparatus reservoir to the patient.

Description:
[0001]    This is a Continuation-In-Part of co-pending Application U.S. Ser. No. 11/725,220 filed Mar. 14, 2007. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to fluid dispensing apparatus. More particularly, the invention concerns medicament dispensers for dispensing medicinal fluids to ambulatory patients. 
       DISCUSSION OF THE PRIOR ART 
       [0003]    A number of different types of medicament dispensers for dispensing medicaments to ambulatory patients have been suggested in the past. Many of the devices seek either to improve or to replace the traditional gravity flow and hypodermic syringe methods which have been the standard for delivery of liquid medicaments for many years. 
         [0004]    The prior art gravity flow methods typically involve the use of intravenous administration sets and the familiar flexible solution bag suspended above the patient. Such gravametric methods are cumbersome, imprecise and require bed confinement of the patient. Periodic monitoring of the apparatus by the nurse or doctor is required to detect malfunctions of the infusion apparatus. Accordingly, the prior art devices are not well suited for use in those instances where the patient must be transported to a remote facility for treatment. 
         [0005]    With regard to the prior art, 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 include: a base assembly, an elastomeric membrane serving as a stored energy means, fluid flow channels for filling and delivery, flow control means, a cover, and an ullage which comprises a part of the base assembly. 
         [0006]    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 pre-filled 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 pre-filled 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. 
       SUMMARY OF THE INVENTION 
       [0007]    By way of brief summary, one form of the dispensing device of the present invention for dispensing medicaments to a patient comprises a supporting structure; a carriage assembly interconnected with the supporting structure for movement between a first position and a second position; a collapsible reservoir carried by the carriage assembly, the collapsible reservoir having an outlet port; guide means connected to the supporting structure for guiding travel of the carriage assembly between the first position and said second positions; a stored energy source operably associated with the carriage assembly for moving the carriage assembly between the first and second positions; and an administration set, including an administration line, interconnected with the outlet port of the collapsible reservoir. 
         [0008]    With the forgoing in mind, it is an object of the present invention to provide a compact fluid dispenser for use in controllably dispensing fluid medicaments, such as, antibiotics, blood clotting agents, analgesics, and like medicinal agents from pre-filled or field-filled containers at a uniform rate. 
         [0009]    Another object of the invention is to provide a small, compact fluid dispenser of simple construction that can be used in the field with a minimum amount of training. 
         [0010]    Another object of the invention is to provide a dispenser in which a stored energy source is provided in the form of a compressible, expandable or retractable member of novel construction that provides the force necessary to continuously and uniformly expel fluid from the device reservoir. 
         [0011]    Another object of the invention is to provide a dispenser of the class described which includes a fluid flow control assembly that precisely controls the flow of the medicament solution to the patient. 
         [0012]    Another object of the invention is to provide a dispenser that includes precise variable flow rate selection. 
         [0013]    Another object of the invention is to provide a fluid dispenser of simple construction, which embodies a pair of spaced-apart, collapsible, pre-filled drug containers that contain the beneficial agents to be delivered to the patient. 
         [0014]    Another object of the invention is to provide a fluid dispenser as described in the preceding paragraph in which the stored energy means comprises a plurality of spaced-apart coil springs. 
         [0015]    Another object of the invention is to provide a dispenser of the class described which includes a novel carriage locking mechanism for releasably locking the carriage in a first position. 
         [0016]    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 reliable in operation. 
         [0017]    Another object of the invention is to provide a fluid dispenser as described in the preceding paragraphs that is easy and inexpensive to manufacture in large quantities. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0018]      FIG. 1  is a generally perspective, top view of one form of the fluid dispensing apparatus of the present invention for dispensing medicaments to a patient. 
           [0019]      FIG. 2  is a generally perspective, exploded view of the fluid dispensing apparatus shown in  FIG. 1  as it appears with a top cover of the device removed. 
           [0020]      FIG. 3  is an enlarged, longitudinal, cross-sectional view of the fluid dispensing apparatus illustrated in  FIG. 1 . 
           [0021]      FIG. 4A  is an enlarged, fragmentary, longitudinal, cross-sectional view of the left-hand portion of the apparatus shown in  FIG. 3 . 
           [0022]      FIG. 4B  is a fragmentary, longitudinal, cross-sectional view, similar to  FIG. 4A , but showing the various components of the apparatus as they appear following delivery to the patient of the fluid contained within the device reservoir. 
           [0023]      FIG. 5  is a top plan view of the fluid reservoir assembly of the invention. 
           [0024]      FIG. 6  is a cross-sectional view taken along lines  6 - 6  of  FIG. 5 . 
           [0025]      FIG. 7  is an enlarged cross-sectional view of the area designated in  FIG. 6  by the numeral “ 7 ”. 
           [0026]      FIG. 8  is a cross-sectional view taken along lines  8 - 8  of  FIG. 3 . 
           [0027]      FIG. 9  is a cross-sectional view taken along lines  9 - 9  of  FIG. 8 . 
           [0028]      FIG. 10  is a view taken along lines  10 - 10  of  FIG. 9 . 
           [0029]      FIG. 11  is a generally perspective, exploded view of the fluid delivery apparatus illustrated in  FIG. 1 . 
           [0030]      FIG. 12  is a generally perspective, exploded view of the multiple flow rate control assembly of the apparatus of the invention and a portion of the administration set. 
           [0031]      FIG. 13  is a cross-sectional view of the rate control assembly depicted in  FIG. 12  as it appears in an assembled configuration. 
           [0032]      FIG. 14  is an exploded, cross-sectional view of the rate control assembly illustrated in  FIG. 13 . 
           [0033]      FIG. 15  is a view taken along lines  15 - 15  of  FIG. 14 . 
           [0034]      FIG. 16  is a top plan view of the selector knob of the present invention for rotating the selector member in a manner to select the rate of fluid flow to the patient. 
           [0035]      FIG. 17  is a cross-sectional view taken along lines  17 - 17  of  FIG. 16 . 
           [0036]      FIG. 18  is a bottom plan view of the selector knob shown in  FIG. 17 . 
           [0037]      FIG. 19  is a top plan view of the selector member of the apparatus which is rotated by the selector knob. 
           [0038]      FIG. 20  is a cross-sectional view taken along lines  20 - 20  of  FIG. 19 . 
           [0039]      FIG. 21  is a bottom plan view of the selector member shown in  FIG. 20 . 
           [0040]      FIG. 22  is front view of the selector element of the rate control means of the invention. 
           [0041]      FIG. 23  is a bottom plan view of the selector element. 
           [0042]      FIG. 24  is a top plan view of the nipple portion of one of the rate control covers of the rate control assembly. 
           [0043]      FIG. 25  is a cross-sectional view taken along lines  25 - 25  of  FIG. 24 . 
           [0044]      FIG. 26  is a top plan view of the other of the rate control covers. 
           [0045]      FIG. 27  is a cross-sectional view taken along lines  27 - 27  of  FIG. 26 . 
           [0046]      FIG. 28  is a view taken along lines  28 - 28  of  FIG. 27 . 
           [0047]      FIG. 29  is a side-elevational view of the selector member housing of the apparatus. 
           [0048]      FIG. 30  is a cross-sectional view taken along lines  30 - 30  of  FIG. 29 . 
           [0049]      FIG. 31  is a view taken along lines  31 - 31  of  FIG. 29 . 
           [0050]      FIG. 32  is a bottom plan view of the rate control plate of the rate control assembly. 
           [0051]      FIG. 33  is a top plan view of the cover member  89  of the rate control assembly. 
           [0052]      FIG. 34  is a cross-sectional view taken along lines  34 - 34  of  FIG. 33 . 
           [0053]      FIG. 35  is a top plan view of a portion of the supporting structure of the apparatus of the invention. 
           [0054]      FIG. 36  is a cross-sectional view taken along lines  36 - 36  of  FIG. 35 . 
           [0055]      FIG. 37  is a view taken along lines  37 - 37  of  FIG. 36 . 
           [0056]      FIG. 38  is a side-elevational view of one form of the control shaft of the flow control means of the invention. 
           [0057]      FIG. 39  is a view taken along lines  39 - 39  of  FIG. 38 . 
           [0058]      FIG. 40  is a view taken along lines  40 - 40  of  FIG. 38 . 
           [0059]      FIG. 41  is an enlarged cross-sectional view taken along lines  41 - 41  of  FIG. 38 . 
           [0060]      FIG. 42  is an enlarged, side-elevational view of one form of the spring knife of the invention that is carried within cavities formed in the control shaft as shown in  FIG. 41 . 
           [0061]      FIG. 43  is a view taken along lines  43 - 43  of  FIG. 42 . 
           [0062]      FIG. 44  is an enlarged, cross-sectional view of a portion of the support structure and of the control shaft of the apparatus illustrating the appearance of the components in their starting position. 
           [0063]      FIG. 45  is a cross-sectional view, similar to  FIG. 44 , but showing the appearance of the components after the initial rotation of the control shaft from a first position to a second position. 
           [0064]      FIG. 46  is a cross-sectional view, similar to  FIG. 45 , but showing the appearance of the components after further rotation of the control shaft from the second position to a third, final position. 
           [0065]      FIG. 47  is a generally perspective, diagrammatic view showing the operating handle of the apparatus in its starting position. 
           [0066]      FIG. 48  is a generally perspective, diagrammatic view illustrating the gripping of the apparatus handle by the operator. 
           [0067]      FIG. 49  is a generally perspective, diagrammatic view illustrating the movement of the operating handle by the operator to open the fluid flow path between the reservoir and the rate control means of the invention. 
           [0068]      FIG. 50  is a generally perspective, diagrammatic view illustrating the operation of the locking means of the apparatus in a manner to lock the carriage to the base component of the apparatus structural support. 
           [0069]      FIG. 51  is a generally perspective, diagrammatic view illustrating the operation of the locking means of the apparatus to release the carriage so as to arm the system to permit delivery of fluid to the patient via the administration set of the apparatus. 
           [0070]      FIG. 52  is a generally perspective, top view of one form of the fluid dispensing apparatus of the present invention for dispensing medicaments to a patient. 
           [0071]      FIG. 53  is a generally perspective, bottom view of the fluid dispensing apparatus shown in  FIG. 52 . 
           [0072]      FIG. 54  is an enlarged, top plan view of the dispensing apparatus illustrated in  FIG. 52 . 
           [0073]      FIG. 55  is a fragmentary, cross-sectional view taken along lines  55 - 55  of  FIG. 54  showing only the upper portion of the apparatus shown in  FIG. 54 . 
           [0074]      FIG. 55A  is a cross-sectional view of the area designated in  FIG. 55  as “ 55 A”. 
           [0075]      FIG. 56  is a view taken along lines  56 - 56  of  FIG. 55 . 
           [0076]      FIG. 57  is a cross-sectional view taken along lines  57 - 57  of  FIG. 56 . 
           [0077]      FIG. 58  is a view taken along lines  58 - 58  of  FIG. 57 . 
           [0078]      FIG. 59  is a fragmentary, cross-sectional view of the lower portion of the apparatus shown in  FIG. 54 . 
           [0079]      FIG. 60  is a generally perspective, exploded view of the portion of the apparatus illustrated in  FIG. 59 . 
           [0080]      FIG. 61  is a view, similar to  FIG. 59 , but showing the configuration of the apparatus after the fluid in the fluid reservoirs of the apparatus has been dispensed to the patient. 
           [0081]      FIG. 62  is a top plan view of one of the fluid containers of the apparatus of the invention shown in  FIG. 52 . 
           [0082]      FIG. 63  is a cross-sectional view taken along lines  63 - 63  of  FIG. 62 . 
           [0083]      FIG. 64  is a greatly enlarged, cross-sectional view of the area designated in  FIG. 63  as “ 64 ”. 
           [0084]      FIG. 65  is a top plan view of the operating shaft of the apparatus of the invention shown in  FIG. 52 . 
           [0085]      FIG. 66  is a greatly enlarged, cross-sectional view taken along lines  66 - 66  of  FIG. 65 . 
           [0086]      FIG. 67  is a greatly enlarged, cross-sectional view taken along lines  67 - 67  of  FIG. 65 . 
           [0087]      FIG. 68  is a bottom plan view of the operating shaft of the apparatus of the invention shown in  FIG. 52 . 
           [0088]      FIG. 69  is a cross-sectional view taken along lines  69 - 69  of  FIG. 68 . 
           [0089]      FIG. 70  is a greatly enlarged, cross-sectional view taken along lines  70 - 70  of  FIG. 68 . 
           [0090]      FIG. 71  is an enlarged, cross-sectional view of the operating shaft of the invention as it appears in its first position with the reservoir nipple in the rate control nipple mated with the operating shaft. 
           [0091]      FIG. 72  is a cross-sectional view, similar to  FIG. 71 , but showing the operating shaft of the invention as it appears rotated into its second position after having sheared the tips of the reservoir nipple and the rate control nipple. 
           [0092]      FIG. 73  is an enlarged, cross-sectional view of the operating shaft of the invention as it appears in its first position with the tip of the carriage locking shaft mated with the operating shaft. 
           [0093]      FIG. 74  is a cross-sectional view, similar to  FIG. 73 , but showing the operating shaft of the invention as it appears rotated into its second position after having sheared the tip of the operating shaft. 
           [0094]      FIG. 75  is a cross-sectional view of the area designated in  FIG. 59  as “ 75 ”. 
           [0095]      FIG. 76  is a cross-sectional view taken along lines  76 - 76  of  FIG. 75 . 
           [0096]      FIG. 77  is a cross-sectional view, similar to  FIG. 75 , but showing the carriage locking shaft moved into the carriage unlocked position. 
           [0097]      FIG. 78  is a cross-sectional view taken along lines  78 - 78  of  FIG. 77 . 
           [0098]      FIG. 79  is a top plan view of the reservoir carriage of the apparatus of the invention shown in  FIG. 52 . 
           [0099]      FIG. 80  is a view taken along lines  80 - 80  of  FIG. 79 . 
           [0100]      FIG. 81  is a cross-sectional view taken along lines  81 - 81  of  FIG. 79 . 
           [0101]      FIG. 82  is a cross-sectional view taken along lines  82 - 82  of  FIG. 70 . 
           [0102]      FIG. 83  is a generally perspective, exploded view of the rate control assembly of the apparatus of the invention shown in  FIG. 52 . 
           [0103]      FIG. 84  is a top plan view of the base plate of the rate control assembly shown in  FIG. 83 . 
           [0104]      FIG. 85  is a cross-sectional view taken along lines  85 - 85  of  FIG. 84 . 
           [0105]      FIG. 86  is a greatly enlarged, cross-sectional view of the area designated in  FIG. 85  as “ 86 ”. 
           [0106]      FIG. 87  is a top plan view of the rate control plate of the rate control assembly shown in  FIG. 83 . 
           [0107]      FIG. 88  is a cross-sectional view taken along lines  88 - 88  of  FIG. 87 . 
           [0108]      FIG. 89  is a generally perspective, exploded view of the control portion of the apparatus of the invention shown in  FIG. 52  that includes the rate control assembly and the operating handle assembly. 
           [0109]      FIG. 90  as a top plan view of the rate control selector housing of the apparatus of the invention shown in  FIG. 52 . 
           [0110]      FIG. 91  is a cross-sectional view taken along lines  91 - 91  of  FIG. 90 . 
           [0111]      FIG. 92  is a view taken along lines  92 - 92  of  FIG. 91 . 
           [0112]      FIG. 93  is a top plan view of the rate control knob of the rate control assembly of the apparatus of the invention shown in  FIG. 52 . 
           [0113]      FIG. 94  is a side-elevational view of the rate control knob. 
           [0114]      FIG. 95  is a bottom plan view of the rate control knob. 
           [0115]      FIG. 96  is a top plan view of the rate control selector member of the apparatus of the invention shown in  FIG. 52 . 
           [0116]      FIG. 97  is a cross-sectional view taken along lines  97 - 97  of  FIG. 96 . 
           [0117]      FIG. 98  is a view taken along lines  98 - 98  of  FIG. 97 . 
           [0118]      FIG. 99  is a side-elevational view of the indexing shaft of the apparatus of the invention for releasably locking the rate control knob and a selected position. 
           [0119]      FIG. 100  is a cross-sectional view taken along lines  100 - 100  of  FIG. 99 . 
           [0120]      FIG. 101  is a generally perspective, top view of still another version of the fluid dispensing apparatus of the present invention for dispensing medicaments to a patient. 
           [0121]      FIG. 102  is an enlarged, top plan view of the dispensing apparatus illustrated in  FIG. 101 . 
           [0122]      FIG. 103  is a fragmentary, cross-sectional view taken along lines  103 - 103  of  FIG. 102  showing the upper portion of the apparatus. 
           [0123]      FIG. 103A  is a fragmentary, cross-sectional view of the area designated in  FIG. 103  as “ 103 A”. 
           [0124]      FIG. 104  is a fragmentary, cross-sectional view showing the lower portion of the apparatus. 
           [0125]      FIG. 105  is a top plan view of one of the fluid containers of this latest form of the apparatus of the invention shown in  FIG. 101 . 
           [0126]      FIG. 106  is a cross-sectional view taken along lines  106 - 106  of  FIG. 105 . 
           [0127]      FIG. 107  is a cross-sectional view, similar to  FIG. 106 , but showing the container in a collapsed configuration as it appears after the fluid in the fluid reservoir of the container has been dispensed to the patient. 
           [0128]      FIG. 108  is a greatly enlarged, cross-sectional view of the area designated in  FIG. 106  as “ 108 ”. 
       
    
    
     DESCRIPTION OF THE INVENTION 
       [0129]    Definitions: As used herein, the following terms have the following meanings: 
       Unitary Container 
       [0130]    A closed container formed from a single component. 
       Continuous/Uninterrupted Wall 
       [0131]    A wall having no break in uniformity or continuity. 
       Patient 
       [0132]    Individual seeking medical care. 
       Hermetically Sealed Container 
       [0133]    A container that is designed and intended to be secure against the entry of microorganisms and to maintain the safety and quality of its contents after pressurizing. 
       Biologic 
       [0134]    A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man. 
       Drug 
       [0135]    As defined by the Food, Drug and Cosmetic Act, “drugs” are “articles (other than food) intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, or to affect the structure or any function.” 
       Drug Product 
       [0136]    A finished dosage form (e.g. tablet, capsule, or solution) that contains the active drug ingredient usually combined with inactive ingredients. 
       Artificial Blood Substitutes 
       [0137]    Blood Substitutes are used to fill fluid volume and/or carry oxygen and other gases in the cardiovascular system. These include volume expanders for inert products, and oxygen therapeutics for oxygen-carrying products. 
         [0000]    Resuscitation fluids 
         [0138]    Infusion of hyperosmotic-hyperoncotic solutions such as hypertonic saline dextran (HSD) as used for resuscitation of traumatic shock and perioperative volume support or as an adjunct to other conventional isotonic crystalloid solutions. Where hypotension is caused by myocardial depression, pathological vasodilatation and extravascation of circulating volume due to widespread capillary leak, a resuscitative effort is attempted to correct the absolute and relative hypovolemia by refilling the vascular tree. Here resuscitation with a small volume of hypertonic-hyperoncotic solution allows systemic and splanchnic hemodynamic and oxygen transport recovery, without an increase in pulmonary artery pressure. Alternate types of normotonic, hyperoncotic, hypertonic, and hypertonic-hyperoncotic solutions can be used for systemic hemodynamic recovery. 
       KVO 
       [0139]    KVO—“keeping-the-vein-open” in an IV set-up, a phrase that refers to the flow rate of a maintenance IV line established as a prophylactic access. 
       Nutritionals 
       [0140]    Dietary supplemental enteral nutrition support feeding solutions used for nasoenteric application typically used in nasogastric, nasoduodenal and nasojejunal or intravenous routes of administration. 
       Beneficial Agent 
       [0141]    The term “beneficial agent” can include any substance or compound that is biologically active and includes any physiologically or pharmacologically active substance that produces a localized or systemic effect in humans or animals and that can be delivered by the present invention to produce a beneficial and useful result. 
       Diluent 
       [0142]    A liquid that dilutes, as in an inert solution used to dilute a medicament. An inert liquid carrier of a beneficial agent. 
       Device 
       [0143]    An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is intended for use in the diagnosis, cure, treatment or prevention of disease. A device does not achieve its intended purpose through chemical action in the body and is not dependent upon being metabolized to achieve its purpose. 
       Apparatus 
       [0144]    An appliance or device for a particular purpose: An integrated group of materials or apparatus used for a particular purpose. The totality of means by which a designated function is performed or a specific task executed, a group of body parts that work together to perform a given function. 
       Reservoir 
       [0145]    A receptacle or chamber for storing a fluid. A part of a machine, apparatus, where liquid is stored. 
       Liquid Container 
       [0146]    A receptacle for holding a liquid. A fluid dispenser that is carried or transported. 
       Collapsible 
       [0147]    To cause to fold, break down, or fall down or inward or as in bent-over or doubled-up so that one part lies on another. 
       Collapsible Container 
       [0148]    A dispensing apparatus in which one or more walls of the container are made of a material which will deform (collapse) when pressure is applied thereto; or a dispensing apparatus having a collapsible or telescoping wall structure. 
       Aseptic Processing 
       [0149]    The term “aseptic processing” as it is applied in the pharmaceutical industry refers to the assembly of sterilized components and product in a specialized clean environment. 
       Sterile Product 
       [0150]    A sterile product is one that is free from all living organisms, whether in a vegetative or spore state. 
       Blow-Fill-Seal Process 
       [0151]    The concept of aseptic blow-fill-seal (BFS) is that a container is formed, filled, and sealed as a unitary container in a continuous manner without human intervention in a sterile, enclosed area inside a machine. In the process multi-stepped, pharmaceutical grade resin is extruded into a tube, which is then formed into a container. A mandrel is inserted into the newly formed container and filled. The container is then sealed, all inside a sterile, shrouded chamber. The product is then discharged to a non-sterile area for packaging and distribution. 
       Integrally Formed 
       [0152]    An article of one-piece construction, or several parts that are rigidly secured together and is smoothly continuous in form and that any such components making up the part have been then rendered inseparable. 
       Septum 
       [0153]    A word borrowed from the Latin “saeptum” meaning a dividing wall or enclosure; thus, a thin partition or membrane that divides two spaces. 
       Slit Septum 
       [0154]    A septum that is partially slit to aid in cannula penetration. 
       Penetrating 
       [0155]    Tending to penetrate; having the power of entering or piercing. 
       Cutting 
       [0156]    Capable of or designed for incising, shearing, or severing as to cut off from a main body. 
       Frangible 
       [0157]    An article, item or object that is capable of being ruptured or broken, but does not necessarily imply any inherent materials weakness. A material object, under load that demonstrates a mechanical strain rate deformation behavior, leading to disintegration. 
       Luer Lock Connector 
       [0158]    A connector used to connect medical apparatus. Classically, the Luer consists of a tapered barrel and a conical male part that fits into it with or without a seal. 
       Surface Treatment 
       [0159]    The processes of surface treatments, more formally surface engineering, to tailor the surfaces of engineering materials to change, alter or modify the physical surface characteristics and improve the function of the materials properties for its intended purpose. 
       Spring 
       [0160]    A mechanical element that can be deformed by a mechanical force such that the deformation is directly proportional to the force or torque applied to it. An elastic machine component able to deflect under load in a prescribed manner and to recover its initial shape when unloaded. The combination of force and displacement in a deflected spring is energy which may be stored when moving loads are being arrested. 
       Constant Force Spring 
       [0161]    Constant force springs are a special variety of extension spring. They are tightly coiled wound bands of pre-hardened spring steel or stainless steel strip with built-in curvature so that each turn of the strip wraps tightly on its inner neighbor. When the strip is extended (deflected) the inherent stress resists the loading force, the same as a common extension spring, but at a nearly constant (zero) rate. The constant-force spring is well suited to long extensions with no load build-up. In use, the spring is usually mounted with the ID tightly wrapped on a drum and the free end attached to the loading force. Considerable flexibility is possible with constant-force springs because the load capacity can be multiplied by using two or more strips in tandem, or back-to-back. Constant force springs are available in a wide variety of sizes. 
         [0162]    Referring to the drawings and particularly to  FIGS. 1 through 3 , one form of the fluid dispensing apparatus of the present invention for dispensing medicaments to a patient is there shown and generally designated by the numeral  50 . The dispensing apparatus here comprises a supporting structure  52 , which includes a housing  54  having an upper portion  55  and a generally cylindrically shaped skirt portion  56 . Supporting structure  52  can be constructed from metal, plastic or any suitable material. Connected to portion  56  is a base segment  57 , the details of construction of which will presently be described. 
         [0163]    Disposed within skirt portion  56  is a carriage assembly  58 , which is movable between a first position shown in  FIGS. 3 and 4A  and a second position shown in  FIG. 4B . As best seen by referring to  FIGS. 4A and 4B , carriage assembly  58  comprises a carriage  60  having a carriage flange  60   a  to which the novel stored energy means of the present invention is operably interconnected. Carriage assembly  58  is releasably locked in its first position by a novel locking means the character of which will be described in the paragraphs, which follow. 
         [0164]    Carried by carriage assembly  58  is a reservoir defining assembly  64  that defines a fluid reservoir  65 . As illustrated in  FIGS. 3 and 6 , reservoir defining assembly  64  includes a top wall  64   a,  an accordion-like side wall  64   b  that is connected to top wall  64   a  and a bottom wall  64   c  that is connected to side wall  64   b.  As illustrated in  FIG. 3 , bottom wall  64   c  includes a cup-shaped portion  64   e.  Reservoir  65  has a combination inlet/outlet  66  that is formed in a reservoir nipple  68  showing a score-line  69  that also comprises a part of the reservoir assembly  64 . 
         [0165]    In the preferred form of the invention shown in  FIG. 6 , nipple  68  is sealably interconnected with top wall  64   a  in accordance with an aseptic blow-fill-seal technique of a character well understood by those skilled in the art. This blow-fill-seal technique comprises the continuous extrusion through an extruder head of a length of a parison in the form of a hollow tube between and through two co-acting first or main mold halves. The method includes the step of cutting off the parison below the extruder head and above the main mold halves to create an opening which allows a blowing and filling nozzle assembly to be moved downwardly into the opening in the parison for molding and thereafter filling a molded container. 
         [0166]    When the container portion of the container assembly is filled with the desired amount of liquid, the blowing and filling nozzle assembly is retracted from the opening in the parison. A separate pair of co-acting second or upper sealing mold halves are then moved together around the exposed length of parison to form and seal the container upper portion. The finished container assembly, completely formed, filled, and sealed as a unitary structure is then conveyed out of the molding apparatus. Further information concerning aseptic blow-fill and blow-fill-seal techniques is available from Weiler Engineering of Elgin, Illinois and from Rommelag of Waiblingen, Germany. 
         [0167]    To controllably move the carriage assembly from its first position to its second position and to thereby controllably expel the fluid from the fluid reservoir  65 , novel stored energy means are provided. These novel stored energy means, which are operably associated with carriage assembly  58 , are here provided in the form of three circumferentially spaced-apart, constant force springs  70  ( FIGS. 3 and 8 ). It is to be understood that an alternate number of springs can be used as may be desired. As illustrated in  FIGS. 3 ,  8  and  9 , constant force springs  70  are housed within spring retainers  72   a  which form a part of a spring housing  72  which includes a cavity  73  having internal threads  73   a.  Housing  72 , in turn, forms a part of the supporting structure  52  of the apparatus. The details of construction and operation of these important constant force springs will presently be described. 
         [0168]    As will be discussed more fully in the paragraphs which follow during the fluid dispensing step, as the carriage assembly  58  is moved by the constant force springs  70  toward its deployed position, the accordion-like sidewall  64   b  of the reservoir assembly  64  will be urged to move into the collapsed configuration shown in  FIG. 4B  and in so doing will cause the fluid contained within the container to be controllably and substantially expelled therefrom. 
         [0169]    To further control the flow of fluid from reservoir  65  toward the administration set  76  of the invention and then on to the patient, novel fluid flow control means are provided. The fluid flow control means, which is carried by the supporting structure  52 , here comprises two cooperating components, namely a rate control means for controlling the rate of fluid flow from the collapsible reservoir toward the administration set and an operating means for controlling fluid flow between the collapsible reservoir and the rate control means. 
         [0170]    Considering first the rate control means of the invention, this important means comprises a rate control housing  82 , which includes a first cover member  84 , that engages a selector element  86  which is received within a cavity  87  provided in selector member  88  and located therewithin by a flat “F” ( FIG. 23 ). Selector member  88 , which has an enlarged diameter portion  88   a  (See  FIG. 14 ), forms a part of the selector means of the invention for selecting the desired rate of fluid flow from the fluid reservoir toward the administration set. Cover member  84  also has a rate control plate cavity  84   b.  As best seen in  FIGS. 13 and 14 , rate control housing  82  includes a second cover member  89  having an outwardly extending attached nipple  92 , the purpose of which will presently be described. 
         [0171]    Interconnected with rate control housing  82  is a selector knob  94 , that includes a central bore  96 , the enlarged, threaded diameter portion  96   a  of which sealably receives the connector hub  77  of the administration set  76  ( FIG. 12 ). The enlarged diameter portion  96   b  of bore  96 , which includes a groove  96   c,  receives the reduced-diameter portion  88   b  of selector member  88  ( FIGS. 13 and 14 ). A threaded cap  95  retains selector member  88  in position. As shown in  FIG. 14 , selector member  88  includes an orientation spine  88   s  that is received in groove  96   c.  Selector knob  94  also includes an outwardly extending flange  94   c  which carries circumferentially spaced finger-gripping elements  100  which assist in rotating the selector knob ( FIG. 12 ). Flange  94   c  also carries an indicator arrow  101 , which, upon rotation of the selector member, aligns with flow rate indicia  104  imprinted on the rim portion  106   a  of a selector member support  106  that supports selector knob  94  ( FIGS. 2 ,  12  and  13 ). Selector member support  106  also includes a skirt portion  106   b  that is interconnected with rate control housing  82  in the manner shown in  FIGS. 3 and 13 . It is to be noted that the movable components of the dispensing apparatus typically carry conventional O-rings to provide appropriate sealing of the components within the apparatus with their mating parts. Throughout the drawings these O-rings are identified as “O”. 
         [0172]    As illustrated in  FIGS. 4A and 4B , first cover member  84  cooperates with second cover  89  to sealably enclose the rate control plate  110  of the invention ( FIGS. 13 and 14 ) that is disposed between covers  84  and  89  and is oriented therebetween by a spline  84   c  on cover  84  and notches “N” formed on cover  89  and plate  110 . Rate control plate  110  is provided with a plurality of fluid flow channels of different lengths, widths, depths and geometry ( FIG. 32 ) that are in fluid communication with outlet  66  of collapsible reservoir  65  via the operating means of the invention, central passageway  92   a  of nipple  92 , and central passageway  68   a  of nipple  68 . After operating the operating means of the invention in a manner presently to be described to permit fluid to flow into the passageway of the nipples  68  and  92  via the operating means, fluid will flow through passageway  89   a,  through a conventional particulate filter  111 , into a well  89   b  and into inlet  110   a  of the rate control plate. From inlet  110   a,  the fluid will flow into the various circuitous fluid channels  112   a,    112   b,    112   c,    112   d,    112   e  and  112   f  formed in the rate control plate, each of which is of a different length, width, depth and geometry (see  FIGS. 12 and 32 ). As each of the channels fills with the medicinal fluid to be dispensed to the patient, the fluid will flow into outlet passageways  114   a,    114   b,    114   c,    114   d,    114   e  and  114   f  respectively formed in rate control cover  84  ( FIG. 28 ). From these outlet passageways, the fluid will flow into and fill circumferentially spaced-apart fluid passageways  116   a,    116   b,    116   c,    116   d,    116   e  and  116   f  formed in cover member  84  (see  FIGS. 26 and 27 ). 
         [0173]    As best seen by referring to  FIG. 21 , selector member  88 , which controllably rotates with knob  94 , is provided with an inlet  120 , a radially extending inlet passageway  122  and an outlet  124  that is in communication with a central passageway  126  via an orifice  86   a  of the selector element  86  ( FIG. 23 ). When the connector hub  77  of the administration set  76  is in position within the cavity  96   a  formed in selector knob  94  in the manner shown in  FIG. 4B , the fluid will flow through the selector film  86  and directly into the inlet  77   a  of the hub  77  of the administration set  76  ( FIGS. 3 ,  20 ,  21 ,  22 , and  23 ). 
         [0174]    With the construction just described, by rotating the selector knob  94 , (See  FIG. 4B ) which, in turn, rotates selector member  88 , inlet  120  of the selector member can be selectively brought into index with one of the axially extending passageways formed in selector member  88 , thereby providing fluid communication with a selected one of the circuitous flow passageways formed in rate control plate  110 . Since outlet passageway  124  is in fluid communication with the administration set  76  in the manner previously described, the rate of fluid flow toward the patient can be precisely controlled by selecting a rate control passageway of appropriate length that is formed in rate control plate  110 . 
         [0175]    Considering now the previously identified operating means of the invention, this important means, which controls fluid flow between collapsible reservoir  65  and passageway  92   a  of nipple  92  of the rate control means, here comprises an operating shaft  128  ( FIGS. 4A ,  4 B and  38 ) that is sealably, rotatably mounted within a generally cylindrical-shaped chamber  130  ( FIG. 4A ,  4 B and  36 ) formed in housing  54  of supporting structure  52  ( FIGS. 3 ,  4 A and  36 ). Operating shaft  128  can be rotated within chamber  130 , which is closed by a closure cap  130   a,  by an “L”-shaped operating handle  134  ( FIG. 2 ) between the position shown in  FIG. 44 , blocking fluid flow from collapsible reservoir  65  toward administration set  76  and the position shown in  FIG. 46  permitting fluid flow from the reservoir toward the administration set. 
         [0176]    Turning particularly to  FIGS. 38 through 41 , operating shaft  128  can be seen to comprise a body portion  128   a  and a reduced-diameter neck portion  128   b.  Circumferentially spaced-apart, generally arcuate-shaped cavities  131  and  132 , which are formed in body portion  128   a,  are strategically located to receive the end portions of nipples  68  and  92  when the operating shaft is held in position within chamber  130  by integral retainer clips  135  in the manner shown in  FIG. 36 . Also formed within operating shaft  128  is a transversely extending fluid passageway  136 , which, upon rotation of the operating shaft by handle  134 , can be moved into alignment with the fluid passageways  68   a  and  92   a  of nipples  68  and  92  respectively (see  FIG. 46 ). 
         [0177]    Mounted within each of the cavities  131  and  132  is a spring knife  140 , which, as indicated in  FIGS. 41 and 42 , includes a cutting edge  140   a  formed proximate one extremity and a pair of mounting clips  142  provided proximate the opposite extremity. Tabs  142   a  of the mounting clips are received within slots  144  formed in body portion  128   a  so as to secure the spring knives within the arcuate cavities in the manner illustrated in  FIG. 44 . With this construction, as the operating shaft  128  is rotated by handle  134  from the position shown in  FIG. 44  into the position shown in  FIG. 45  the spring knives will cleanly sever the sealed tip portions  68   b  and  92   b  of nipples  68  and  92  respectively. Continued rotation of operating member  128  will move sealed tip portions  68   b  and  92   b  into the cavities for rotation therewith ( FIG. 45 ) and will move transverse passageway  136  into alignment with passageways  68   a  and  92   a  in a manner shown in  FIG. 46 . With the operating member in this position fluid can flow freely from reservoir  65  toward the rate control means of the invention via passageways  68   a  and  92   a  of nipples  68  and  92 . 
         [0178]    From passageway  68   a,  fluid will flow through passageway  136 , through passageway  92   a,  through conventional particulate filter  111 , through well  89   b,  through outlet  89   a,  into inlet  110   a  of rate control plate  110  of the rate control assembly and then into the various circuitous fluid channels  112   a,    112   b,    112   c,    112   d,    112   e  and  112   f  formed in the rate control plate (see  FIGS. 3 ,  13  and  32 ). Rate control plate  110 , which can be constructed from various plastics, is oriented relative to members  84  and  89  by the previously identified notches “N” and spines “S” and  84   c.  Filter  111  is maintained in position within cavity  92   b  of member  92  which is received in a cavity  89   b  formed in plate  89 . As each of the channels fills with the medicinal fluid to be dispensed to the patient, the fluid will flow next into outlet passageways  114   a,    114   b,    114   c,    114   d,    114   e  and  114   f  respectively formed in rate control cover  84  ( FIG. 28 ). From these outlet passageways, the fluid flows into and fills circumferentially spaced-apart fluid passageways  116   a,    116   b,    116   c,    116   d,    116   e  and  116   f  formed in cover member  84  (see  FIGS. 26 and 27 ). By controllably rotating knob  94  which in turn rotates the selector member  88 , inlet  120  thereof can be selectively brought into index with one of the fluid passageways formed in cover member  84  via element  86 , thereby providing fluid communication with a selected one of the circuitous flow passageways formed in rate control plate  110 . Since outlet passageway  124  of the selector member  88  is in fluid communication with the administration set  76  in the manner previously described the fluid can be delivered to the patient at a selected controlled rate of flow. 
         [0179]    With the apparatus in the configuration shown in  FIG. 1  and with the fluid reservoir  65  filled with the medicament to be dispensed to the patient, the dispensing operation can be commenced by removing the top cover  150  which is snapped over a cover connector  152  that protrudes from the rate control cover  84 . With the top cover removed, the administration line  76   a  of the administration set  76  can be unwrapped from the sleeve  106   b  of the selector knob support  106  about which it has been coiled (see  FIG. 3 ). Removal of the top cover  150  also exposes the selector knob  94  so that the fluid flow rate can be selected by rotating the selector knob to the desired flow rate indicated by the indicia  104  imprinted on the rim of the selector knob support  106  ( FIG. 2 ). In this regard, it is to be noted that selector knob  94  is provided with a plurality of circumferentially spaced cavities  97   c  ( FIG. 17 ) that are engaged by a protuberance  106   p  formed on inwardly extending flange  106   d  of support  106  ( FIGS. 13 and 31 ). With the desired flow rate thusly set, the operating shaft  128  is next rotated through the use of the operating handle  134  from the starting position shown in  FIG. 47  to the fully rotated position shown in  FIG. 49 . In this way, communication is opened between the reservoir outlet  66  and passageway  92   a  of nipple  92  which, in turn, is in communication with the rate control assembly of the invention. 
         [0180]    Following the controlled rotation of the operating shaft  128  in the manner shown in  FIGS. 44 through 49 , the carriage locking means of the invention can now be manipulated in the manner illustrated in  FIG. 51  to release the carriage  60  from base segment  57  in order to permit the stored energy means, or constant force springs  70  to move the carriage from the fully deployed or extended starting position shown in  FIG. 4A  to the retracted position shown in  FIG. 4B . In this regard, as best seen in  FIGS. 4A ,  4 B and  51 , the carriage locking means here comprises the previously identified base segment  57  which includes a locking sleeve  57   a  that is provided with a cam groove  155  that is adapted to mate with a male thread  157  formed on the base  57  of container  64  (see  FIGS. 4A and 6 ). With this construction, upon rotating base segment  57  so as to release the carriage in the manner shown in  FIGS. 4B and 51 , carriage  60  is then free to move in response to the urging of the constant force springs  70  from the position shown in  FIG. 4A  to the fluid delivery position shown in  FIG. 4B . As the carriage moves into the fluid delivery position the fluid contained within reservoir  65  will be caused to controllably flow toward reservoir outlet  66 , into fluid passageway  68   a  of nipple  68 , through passageway  136  formed in control member  128  and into passageway  92   a  of nipple  92 . From passageway  92   a,  fluid will flow through conventional particulate filter  111 , into the well  89   b,  through outlet  89   a,  and into inlet  110   a  of rate control plate  110  and then into the various circuitous fluid channels  112   a,    112   b,    112   c,    112   d,    112   e  and  112   f  formed in the rate control plate (see  FIG. 32 ). As each of the channels fills with the medicinal fluid to be dispensed to the patient, the fluid will flow into and fill circumferentially spaced-apart fluid passageways  114   a,    114   b,    114   c,    114   d,    114   e  and  114   f  formed in cover member  84  (see  FIG. 28 ). By controllably rotating the selector knob  94 , inlet  120  of selector member  88  can be selectively brought into index with one of the fluid passageways  116   a,    116   b,    116   c,    116   d,    116   e  and  116   f  formed in cover member  84 , thereby providing fluid communication with a selected one of the circuitous flow rate control passageways formed in rate control plate  110  and in this way select the desired rate of fluid flow to the administration set and then on to the patient. 
         [0181]    In the present form of the invention, administration set  76 , which comprises a part of the dispensing means of the invention for delivering medicinal fluids to the patient, includes, in addition to administration line  76   a,  a conventional “Y”-site injection septum or port  76   b,  a conventional gas vent and particulate filter  76   c  and a line clamp  76   d.  Provided at the distal end of the administration line is a Luer connector  76   e  of conventional construction ( FIG. 2 ) which enables the apparatus to be interconnected with the patient in a conventional manner. 
         [0182]    The stored energy members or constant-force springs  70 , which are a special variety of extension spring, are 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, Calif. Constant force extension springs are basically high stress, long deflection apparatus that offer great advantages when used in applications, such as the present application, where very low or zero gradient is desired, where space is a factor and where very high reliability, accuracy, and linear force tolerance is required. Constant force springs, such as springs  70 , provide markedly superior constant force loading when compared to conventional helical extension or like conventional types of springs. A constant force spring is typically a roll of pre-stressed metal strip that exerts a nearly constant restraining force to resist uncoiling or recoiling. The force is constant over time because the change in the radius of the curvature is constant. Springs  70  can be of a laminate construction, or alternatively spring  70  can comprise a single spring element of the character shown in the drawings. 
         [0183]    Turning now to  FIGS. 52 through 59 , an alternate form of the dispensing apparatus of the present invention for dispensing medicaments to a patient is there shown and generally designated by the numeral  160 . This alternate form of dispensing apparatus is similar in some respects to that shown in  FIGS. 1 through 51  and like numerals are used in  FIGS. 52 through 59  to identify like components. As before, the dispensing apparatus here includes a supporting structure  162  which includes an upper control portion  164  and a generally oval-shaped lower portion  166  that is interconnected with the upper portion in the manner best seen in  FIG. 55  of the drawings. 
         [0184]    The primary differences between this latest form of dispensing apparatus of the invention and that illustrated in  FIGS. 1 through 51  and previously described herein reside in the provision of a pair of reservoir defining assemblies, or fluid containers that are housed within supporting structure  162  that is of a totally different construction and in the provision of totally differently configured stored energy means for acting on the reservoir defining assemblies. 
         [0185]    Disposed within lower portion  166  of the supporting structure is a carriage assembly  170  that supports the reservoir defining assemblies  167  in the manner shown in  FIG. 59 . Carriage assembly  170  is movable between a first position shown in  FIG. 59  and a second position shown in  FIG. 61 . 
         [0186]    As best seen by referring to  FIGS. 59 and 60 , the carriage assembly  170  comprises a carriage  172  with which the novel stored energy means of the present invention is operably associated. The carriage assembly is releasably locked in its first lowered position by a novel locking means the character of which will be described in the paragraphs that follow. 
         [0187]    The reservoir defining assemblies  167  are similar in construction to reservoir assembly  64  and each includes a sealed container  174  having a top wall  174   a,  an accordion-like side wall  174   b  that is connected to top wall  174   a  and a bottom wall  174   c  that is connected to a bellows-like side wall  174   b  (See  FIG. 63 ). The sealed containers  174  of the preferred form of the invention as shown in  FIG. 63  are formed in accordance with the previously described an aseptic blow-fill-seal technique. Each sealed container  174  defines a reservoir  175  that has a combination inlet/outlet  176  ( FIG. 64 ). Combination inlet/outlet  176  is formed by a reservoir nipple  178  having a score-line  179 . Reservoir nipple  178  also comprises a part of the reservoir defining assembly  167 . 
         [0188]    To controllably move the carriage assembly  170  from its first position to its second position, novel stored energy means are provided. These novel stored energy means, which are operably associated with carriage assembly  170 , are here provided in the form of three transversely spaced-apart coiled springs  180 . As illustrated in  FIGS. 59 and 61 , one end  180   a  of each of the coil springs  180  is disposed in engagement with a generally oval-shaped support plate  182  that is carried by an end cap  184 . Support plate  182  is provided with three transversely spaced-apart, generally cylindrically shaped, cup-like spring receiving portions  182   a.  The other end  180   b  of each of the coil springs  180  is disposed in engagement with carriage  172  ( FIG. 59 ). 
         [0189]    As indicated in  FIG. 61 , support  182  also includes guide means for guiding travel of the carriage assembly between the first position shown in  FIG. 59  and the second position shown in  FIG. 61 . This guide means here comprises a pair of outwardly extending, spaced-apart guides  182   b  that function to guide the travel of carriage assembly  170  between its first and second positions. Also extending from support plate  182  is a centrally disposed locking shaft tube  208  the purpose of which will presently be described. 
         [0190]    With the construction described in the preceding paragraphs, when the fluid reservoir is accessed by the reservoir accessing means of the invention and when the carriage locking means is manipulated in a manner presently to be described to unlock the carriage, coil springs  180  will move from their retracted position shown in  FIG. 59  to their expanded position shown in  FIG. 61 , and in so doing will controllably move the carriage from its starting position shown in  FIG. 59  to its fully deployed, or extended position shown in  FIG. 61 . Carriage assembly  170  is releasably locked in its first position by a novel locking means the character of which will presently be described. 
         [0191]    As the carriage assembly moves toward its deployed position, the accordion sidewalls  174   b  of the containers  174  will move into their collapsed configuration shown in  FIG. 61  and in so doing will cause the medicinal fluid contained within the containers to be controllably expelled therefrom. 
         [0192]    To further control the flow of medicinal fluid from reservoirs  175  toward the administration set  76  of the invention and then on to the patient, flow control means are provided. As before this novel fluid flow control means, comprises two cooperating components, namely a rate control means for controlling the rate of fluid flow from the collapsible reservoirs to the patient and an operating means for controlling fluid flow between the collapsible reservoirs and the rate control means. The important operating means of this latest form of the invention here comprises an operating shaft  188  that is of a somewhat different construction that is rotatably mounted within a generally cylindrically shaped chamber  190   a  formed in reservoir cover member  190  that forms, a part of the upper control portion  164  of the supporting structure ( FIGS. 55 ,  56 ,  57  and  58 ). 
         [0193]    As before, operating shaft  188  can be rotated within chamber  190  by a generally “L”-shaped operating handle  191  between a first position blocking fluid flow from collapsible reservoirs  175  toward administration set  76  and a second position permitting fluid flow from the reservoirs toward the administration set  76 , which is substantially identical to that previously described (See  FIG. 52 ). Generally “L”-shaped operating handle  191  includes a groove  191   a  that closely receives the end portion  188   a  of operating shaft  188  in the manner shown in  FIG. 54 . Handle  191  is releasably maintained in its connected position by a handle release member  193  that has locking arms  193   a  that engage a flat  188   b  ( FIG. 69 ) formed on the operating handle and the control portion  164  in the manner illustrated in  FIGS. 52 and 55 . 
         [0194]    Referring to  FIGS. 65 through 70 , operating shaft  188  can be seen to include a pair of transversely spaced-apart container nipple cavities  194  that are strategically located to receive the upper end portions  178   a  of container nipples  178  the lower portions of which are received within cavities  190   b  of reservoir cover  190  ( FIG. 57 ). Operating shaft  188  also includes a pair of transversely spaced-apart rate control nipple cavities  196  that are strategically located to receive the lower end portions  198   a  of rate control nipples  198  ( FIG. 55 ), the upper portions of which are received within cavities  190   c  of reservoir cover  190  ( FIG. 57 ). With this construction, as the operating shaft  188  is rotated by the operating handle  191  from it first position shown in  FIG. 71  into its second position shown in  FIG. 72 , end portions  178   a  of container nipples  178  as well as the end portions  198   a  of the rate control nipples  198  will be cleanly sheared in the manner depicted in  FIG. 72 . At the same time, the spaced-apart fluid flow passageways  200  that are formed in operating shaft  188  will move from their first positions ( FIG. 71 ) into their second positions ( FIG. 72 ) thereby opening a fluid flow pathway between reservoirs  175  and the rate control means of the invention via nipples  178  and  198 . 
         [0195]    As the operating shaft  188  is rotated by the operating handle  191  from it first position into its second position, the tip  204   a  of a uniquely configured carriage locking shaft  204  will also be cleanly sheared in the manner depicted in  FIG. 74 . Carriage locking shaft  204 , which forms a part of the carriage locking means of the invention, functions to releasably lock carriage  172  in its first position as shown in  FIG. 59 . As illustrated in  FIG. 59 , carriage locking shaft  204  extends from operating shaft  188  to carriage  172  and is telescopically movable within a locking shaft tube  208  that extends outwardly from the base  182   a  of support plate  182 . As indicated in  FIG. 59 , tip  204   a  passes through a bore  190   d  formed in reservoir cover  190  and into a cavity  206  formed in the central portion of operating shaft  188  (see also  FIGS. 57 and 69 ), while the opposite end  204   b  of the locking shaft is in engagement with the locking shaft biasing means of the invention that functions to continuously urge the locking shaft in a direction toward operating shaft  188 . The locking shaft biasing means is here provided in the form of a conventional coil spring  210  which also forms a part of the carriage locking means of the invention. 
         [0196]    As best seen in  FIGS. 59 and 75 , carriage  172  is locked in its first, or lowered position, by a plurality of carriage locking balls  212  that are initially received within cavities  208   a  formed in locking shaft tube  208 . Carriage locking balls  212  are also received within a centrally located pocket  214  that is formed in carriage  172  (see  FIGS. 77 ,  79 ,  81  and  82 ) and circumscribes locking shaft tube  208  in the manner indicated in  FIG. 75 . 
         [0197]    When the operating shaft  188  is rotated by the operating handle  191  from its first position into its second position so as to cause the tip  204   a  of a carriage locking shaft  204  to be cleanly sheared along a score-line  205  (See  FIG. 59 ) in the manner depicted in  FIG. 74 , coil spring  210  will urge the carriage locking shaft upwardly so that the upper end  204   a  thereof is received within a cavity  216  that is formed in operating shaft  188  and has been moved into index with the carriage locking shaft (see  FIGS. 73 and 74 ). As the carriage locking shaft moves upwardly in the manner shown in  FIG. 77 , the carriage locking balls  212  will roll into a groove  218  formed in the carriage locking shaft thereby releasing the carriage and permitting it to move toward its second deployed position due to the urging of the stored energy means, or springs  180 . 
         [0198]    Upon release of the carriage in the manner described in the preceding paragraph, coil springs  180  will move from their retracted position shown in  FIG. 59  to their expanded position shown in  FIG. 61 , and in so doing will controllably move the carriage from its starting position shown in  FIG. 59  to its fully deployed, or extended position shown in  FIG. 61 . 
         [0199]    As the carriage assembly moves toward its deployed position, the accordion sidewalls  174   b  of the containers  174  will move into the collapsed configuration shown in  FIG. 61  and in so doing will cause the medicinal fluid contained within the containers to be controllably expelled therefrom. The fluid will flow through the central fluid passageways  178   p  of the container nipples  178 , through the spaced-apart fluid flow passageways  200 , through the central passageways  198   p  of the rate control nipples  198  and then into the inlets  222  of the base plate  224  of the rate control assembly  226  ( FIGS. 83 and 85 ). The fluid will then flow through channel  228  and outwardly of outlet  230 . From outlet  230  the fluid will flow into the various circuitous fluid channels  232   a,    232   b,    232   c,    232   d,    212   e  and  232   f  formed in the rate control plate  232  via rate control plate inlet  233  (see  FIGS. 83 and 88 ). 
         [0200]    Rate control plate  232 , which can be constructed from various plastics, is oriented relative to base plate  224  so that inlet  233  of rate control plate  232  is aligned with the outlet  230  of base plate  224 . As each of the channels in the rate control plate fills with the medicinal fluid to be dispensed to the patient, the fluid will flow next into a transfer plate  234  via outlet passageways  236   a,    236   b,    236   c,    236   d,    236   e  and  236   f  respectively formed in rate control plate ( FIG. 87 ). From the transfer plate  234  the fluid flows into circumferentially spaced-apart outlets of a rate control top plate  238  via circumferentially spaced-apart outlets  234   a,    234   b,    234   c,    234   d,    234   e  and  234   f  formed in transfer plate  234  ( FIG. 83 ). From the transfer plate the fluid flows into circumferentially spaced-apart outlets  238   a,    238   b,    238   c,    238   d,    238   e  and  238   f  formed in rate control top plate  238 . From outlets  238   a,    238   b,    238   c,    238   d,    238   e  and  238   f,  the fluid flows into and fills circumferentially spaced-apart, generally “L”-shaped fluid passageways  240   a,    240   b,    240   c,    240   d,    240   e  and  240   f  formed in a rate control housing  240  that is superimposed over the rate control assembly  226  in the manner shown in FIG.  55 . As illustrated in  FIGS. 55 ,  90  and  91 , passageways  240   a,    240   b,    240   c,    240   d,    240   e  and  240   f  are adapted to selectively communicate with a generally “L”-shaped fluid passageway  244   a  formed in a selector member  244  that is operably associated with a control knob  246  in the manner shown in  FIG. 55 . Selector member  244 , which is provided with an elastomeric coating  244   b,  is sealably received within a chamber  240   g  formed in control housing  240  and can be controllably rotated by control knob  246 . In this regard, control knob  246  is provided with a shoulder  246   a  ( FIG. 94 ) that is adapted to engage a mating shoulder  244   c  formed on Selector member  244  ( FIG. 94 ). 
         [0201]    By controllably rotating control knob  246  selector member  244  can be rotated in a manner such that the inlet  244   a  thereof can be selectively brought into index with one of the fluid passageways  240   a,    240   b,    240   c,    240   d,    240   e  and  240   f  formed in a rate control housing  240  thereby providing fluid communication with a selected one of the circuitous flow passageways  232   a,    232   b,    232   c,    232   d,    232   e  and  232   f  formed in the rate control plate  232 . Since outlet  244   a  of the selector member  244  is in fluid communication with the administration set  76  in the manner shown in the drawings, the fluid from the reservoirs  175  can be delivered to the patient at a selected controlled rate of flow. 
         [0202]    In operation, after removing a bottom closure cap  247  that has a utility hook  247   a  ( FIG. 53 ), the apparatus is in the operating configuration shown in FIG.  52 . With the fluid reservoirs  175  filled with the medicament to be dispensed to the patient, the dispensing operation can be commenced by rotating the selector knob  246  to the desired flow rate indicated by the indicia  250  imprinted on the body  246   c  of the selector knob  246 , which indicia is viewable through a window  257   a  formed in a control knob housing  262  that circumscribes the control knob and is supported by rate control housing  240  (see  FIG. 55 ). In this regard, it is to be noted that the rim  246   b  of the selector knob is provided with a plurality of circumferentially spaced cavities  258  ( FIG. 89 ) that are engagable by an indexing shaft  260  that is carried within a bore  262   a  formed in control knob housing  262 . As best seen in  FIGS. 55A and 99 , indexing shaft  260 , which is biased upwardly be a small coil spring  261 , includes a top portion  260   a,  a bottom portion  260   b  and is provided with a transverse slot  260   c.  By exerting a downward pressure on the top surface  260   a  of the indexing shaft against the urging of spring  261  until the bottom portion of the indexing shaft engages a shoulder  263  formed in the rate control housing, slot  260   c  can be brought into index with flange portion  246   b  of the control knob thereby allowing free rotation of the control knob to the desired rate control setting. 
         [0203]    With the desired flow rate thusly set, the operating shaft  188  is next rotated through the use of the operating handle  191  from the starting position shown by the solid lines in  FIG. 52  to the fully rotated position indicated by the phantom lines in  FIG. 52 . In this way, communication is opened between the reservoirs  175  and passageways  178   a  of nipples  178  which, in turn, are in communication with the rate control assembly of the invention via passageway  200  of the operating shaft  188  and passageways  198   a  of the rate control nipples  198 . 
         [0204]    After flowing through the various circuitous fluid channels  232   a,    232   b,    232   c,    232   d,    232   e  and  232   f  formed in the rate control plate  232 , the fluid will flow into transfer plate, into the circumferentially spaced-apart outlets  238   a,    238   b,    238   c,    238   d,    238   e  and  238   f  formed in rate control top plate  238  and into the circumferentially spaced-apart, generally “L”-shaped fluid passageways  240   a,    240   b,    240   c,    240   d,    240   e  and  240   f  formed in a rate control housing  240 . Next, the fluid will flow into the generally “L”-shaped fluid passageway  244   a  formed in a selector member  244  that is aligned with the selected passageway formed in a rate control housing  240  and then on to the administration set  76  via passageway  264   a  of the centrally disposed rate control nipple  264  ( FIGS. 55 and 83 ), via fluid passageway  266  formed in transfer plate  234  via transfer nipple  268  and via passageway  270  formed in rate control housing  240 . The fluid will then flow onward toward the patient at a precisely controlled rate. 
         [0205]    If at any time it is desired to disable the device and render it inert, disable means are provided in the form of a disabling member  274  ( FIGS. 55 ,  89  and  91 ) that includes a disabling shaft  274   a  that will block fluid flow through outlet fluid passageway  270  ( FIG. 55 ) when the disabling member is urged inwardly within a cavity  276  formed in the device rate control housing  240  ( FIG. 91 ) causing shaft  274   a  to intersect and block passageway  270 . 
         [0206]    As illustrated in  FIG. 53 , housing  166  is provided with a belt clip receiving member  280  to which a belt clip  282  can be slid ably interconnected. When the belt clip  282  is connected with receiving member  280  the device can be conveniently carried on the user&#39;s belt during the medicament dispensing step. 
         [0207]    As best seen in  FIG. 52 , the lower portion  166  of supporting structure  162  also carries consumption determining means for determining the amount of fluid remaining in the reservoirs  175  of the reservoir defining containers  174 . This consumption determining means here comprises a consumption gauge  285  that includes a viewing window  285   a  that enables the user to view the position of the carriage  172  as it travels upwardly due to the urging of springs  180 . Indicia  287 , which are imprinted on the lower portion  166  of the supporting structure  162  indicate the amount of fluid remaining in the reservoirs of the reservoir defining containers  174  as a function of the position of the carriage  172 . 
         [0208]    Turning now to  FIGS. 101 through 108 , still another form of the dispensing apparatus of the present invention for dispensing medicaments to a patient is there shown and generally designated by the numeral  290 . This alternate form of the dispensing apparatus is similar in many respects to the previously described embodiments and like numerals are used in  FIGS. 101 through 108  to identify like components. The primary difference between this latest form of dispensing apparatus of the invention and that previously described resides in the differently configured fluid reservoir defining containers. More particularly, rather than having bellows-like side walls, the bottle-like collapsible containers  292  of this latest form of the apparatus comprise side walls  292   a  that telescope in the manner shown in  FIGS. 106 and 107  of the drawings. 
         [0209]    As in the earlier described embodiments of the invention, the dispensing apparatus here includes a supporting structure  162  which includes an upper control portion  164  and a generally oval-shaped lower portion  166  that is interconnected with the upper portion in the manner best seen in  FIG. 103  of the drawings. Disposed within lower portion  166  of the supporting structure is a carriage assembly  170  that is substantially identical in construction and operation to that previously described and functions to support the differently configured reservoir defining assemblies  292  in the manner shown in  FIG. 104 . Carriage assembly  170  is movable by the stored energy means of the invention, which is also substantially identical in construction and operation to that previously described between a first, lower position shown in  FIG. 104  and a second, raised more deployed position wherein the reservoir defining assemblies are moved into the collapsed configuration shown in  FIG. 107 . 
         [0210]    The reservoir defining assemblies  292  each includes a sealed container  294  having a top wall  294   a,  an telescoping side wall  294   b  that is connected to top wall  294   a  and a bottom wall  294   c  that is connected to telescoping side wall  294   b.  The sealed containers  294  are preferably formed in accordance with the previously described aseptic blow-fill-seal technique. Each sealed container  294  defines a reservoir  295  that has a combination inlet/outlet  296  ( FIG. 106 ). Combination inlet/outlet  296  is formed by a reservoir nipple  298  having a score-line  299  (See  FIG. 108 ). Reservoir nipple  298  also comprises a part of the reservoir defining assembly  292 . 
         [0211]    As in the last described embodiment of the invention, the novel stored energy means, which are operably associated with carriage assembly  170 , are provided in the form of three transversely spaced-apart coiled springs  180 . As illustrated in  FIG. 104 , one end  180   a  of each of the coil springs  180  is disposed in engagement with a generally oval-shaped support plate  182  that is carried by the lower housing  166 . Support plate  182  is provided with three transversely spaced-apart, generally cylindrically shaped, cup-like spring receiving portions  182   a.  The other end  180   b  of each of the coil springs  180  is disposed in engagement with carriage  172 . 
         [0212]    As before, support  182  also includes guide means for guiding travel of the carriage assembly between its first locked position shown in  FIG. 104  and its second, deployed position. This guide means is substantially identical in construction and operation to that previously described. 
         [0213]    When the fluid reservoirs are accessed by the reservoir accessing means of the invention and when the carriage locking means is manipulated in a manner previously described to unlock the carriage, coil springs  180  will move from their retracted position shown in  FIG. 104  to their expanded position, and in so doing will controllably move the carriage from its starting position shown in  FIG. 104  to its fully deployed, or extended position. Carriage assembly  170  is releasably locked in its first position by a novel locking means, which are also substantially identical in construction and operation for those previously described. 
         [0214]    As the carriage assembly moves toward its deployed position, the telescoping sidewalls  292   a  of the containers  292  will move into the configuration shown in  FIG. 107  and in so doing will cause the medicinal fluid contained within the containers to be controllably expelled therefrom. 
         [0215]    To further control the flow of medicinal fluid from reservoirs  295  toward the administration set  76  of the invention and then on to the patient, flow control means are provided. As before this novel fluid flow control means, comprises two cooperating components, namely a rate control means for controlling the rate of fluid flow from the collapsible reservoirs to the patient and an operating means for controlling fluid flow between the collapsible reservoirs and the rate control means. Both the rate control means and the operating means of this latest form of the invention are substantially identical in construction and operation to those previously described. The important operating means includes an operating shaft  188  that is controllably rotated by a generally “L”-shaped operating handle  191 . As in the earlier described embodiment of the invention, operating shaft  188  rotates within a generally cylindrically shaped chamber  190   a  formed a reservoir cover member  190  that forms a part of the upper control portion  164  of the supporting structure ( FIGS. 55 ,  56 ,  57  and  58 ). 
         [0216]    In the operation of the apparatus of this latest form of the invention, as the operating shaft  188  is rotated by the operating handle  191  from it first position into its second position shown in the phantom lines of  FIG. 101 , end portions  298   a  of container nipples  298  as well as the end portions  198   a  of the rate control nipples  198  will be cleanly sheared in the manner depicted in  FIG. 72 . At the same time, the spaced-apart fluid flow passageways  200  that are formed in operating shaft  188  will move from their first positions ( FIG. 71 ) into their second positions ( FIG. 72 ) thereby opening a fluid flow pathway between reservoirs  295  and the rate control means of the invention via nipples  298  and  198 . 
         [0217]    As the operating shaft  188  is rotated by the operating handle  191  from it first position into its second position, the tip  204   a  of a uniquely configured carriage locking shaft  204  will also be cleanly sheared in the manner depicted in  FIG. 74 . Carriage locking shaft  204 , which is also substantially identical in construction and operation to that described in connection with the previously described embodiment, functions to releasably lock carriage assembly  170  in its first position as shown in  FIG. 104 . As before, and as illustrated in  FIG. 107 , carriage locking shaft  204  extends from operating shaft  188  to carriage  172  and is telescopically movable within a locking shaft tube  208  that extends outwardly from the base  182   a  of support plate  182 . As indicated in  FIG. 103 , tip  204   a  passes through a bore  190   d  formed in reservoir cover  190  and into a cavity  206  formed in the central portion of operating shaft  188 , while the opposite end  204   b  of the locking shaft is in engagement with the locking shaft biasing means of the invention that functions to continuously urge the locking shaft in a direction toward operating shaft  188 . As before, the locking shaft biasing means is here provided in the form of a conventional coil spring  210  which also forms a part of the carriage locking means of the invention. 
         [0218]    Carriage  172  is locked in its first, or lowered position, by a plurality of carriage locking balls  212  that are initially received within cavities  208   a  formed in locking shaft tube  208 . Carriage locking balls  212  are also received within a centrally located pocket  214  that is formed in carriage assembly  172  (see  FIGS. 79 ,  81  and  82 ) and circumscribes locking shaft tube  208  in the manner indicated in  FIG. 75 . When the operating shaft  188  is rotated by the operating handle  191  from it first position into its second position so as to cause the tip  204   a  of a carriage locking shaft  204  to be cleanly sheared along a score-line  205  in the manner depicted in  FIG. 74 , coil spring  210  will urge the carriage locking shaft upwardly so that the upper end  204   b  thereof is received within a cavity  216  that is formed in operating shaft  188  and has been moved into index with the carriage locking shaft (see  FIGS. 73 and 74 ). As the carriage locking shaft moves upwardly in the manner shown in  FIG. 77 , the carriage locking balls  212  will roll into a groove  218  formed in the carriage locking shaft thereby releasing the carriage assembly and permitting it to move toward its second deployed position due to the urging of the stored energy means, or springs  180 . 
         [0219]    Upon release of the carriage assembly in the manner described in the preceding paragraph, coil springs  180  will move from their retracted position shown in  FIG. 104  to their expanded position, and in so doing will controllably move the carriage assembly from its starting position shown in  FIG. 104  to its fully deployed position. 
         [0220]    As the carriage assembly moves toward its deployed position, the telescoping sidewalls  292   a  of the containers  292  will move into the collapsed configuration shown in  FIG. 107  and in so doing will cause the medicinal fluid contained within the containers to be controllably expelled therefrom. The fluid will flow through the central fluid passageways  298   p  of the container nipples  298 , through the spaced-apart fluid flow passageways  200 , through the central passageways  198   p  of the rate control nipples  198  and then into the inlets  222  of the base plate  224  of the rate control assembly  226  ( FIG. 85 ). In the manner previously described, the fluid will then flow through channel  228  and outwardly of outlet  230 . From outlet  230  the fluid will flow into the various circuitous fluid channels  232   a,    232   b,    232   c,    232   d,    232   e  and  232   f  formed in the rate control plate  232  via rate control plate inlet  233  (see  FIGS. 83 and 87 ). 
         [0221]    As each of the channels in the rate control plate fills with the medicinal fluid to be dispensed to the patient, the fluid will flow next into a transfer plate  234 . From the transfer plate  234  the fluid flows into and fills circumferentially spaced-apart, generally “L”-shaped fluid passageways  240   a,    240   b,    240   c,    240   d,    240   e  and  240   f  formed in a rate control housing  240  that is superimposed over the rate control assembly  226  in the manner shown in  FIG. 55 . As illustrated in  FIGS. 55 ,  89 ,  90  and  97  passageways  240   a,    240   b,    240   c,    240   d,    240   e  and  240   f  are adapted to selectively communicate with a generally “L”-shaped fluid passageway  244   a  formed in a selector member  244  that is operably associated with a control knob  246  in the manner shown in  FIG. 55 . Selector member  244 , which is provided with an elastomeric coating  244   b,  is sealably received within a chamber  240   g  formed in control housing  240  and, in the manner previously described, can be controllably rotated by control knob  246 . Since outlet  244   a  of the selector member  244  is in fluid communication with the administration set  76  in the manner shown in the drawings, the fluid from the reservoirs  175  can be delivered to the patient at a selected controlled rate of flow in the same manner as described in connection with the previous embodiment of the invention. 
         [0222]    As illustrated in  FIG. 101 , the lower portion  166  of supporting structure  162  of this latest form of the invention also carries consumption determining means for determining the amount of fluid remaining in the reservoir  295  of the reservoir defining containers  292 . This consumption determining means, which is substantially identical in construction and operation of that previously described, here comprises a consumption gauge  285  that includes a viewing window  285   a  that enables the user to view the position of the carriage  172  as it travels upwardly due to the urging of springs  180 . Indicia  287 , which are imprinted on the lower portion  166  of the supporting structure  162  indicate the amount of fluid remaining in the reservoir defining containers  292  as a function of the position of the carriage  172 . 
         [0223]    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.