Abstract:
A dispensing device for dispensing pain management medicaments to a patient comprises first and second threadably interconnectable sub-assemblies. The first of these sub-assemblies houses a fluid reservoir defining component while the second comprises a fluid delivery and control assembly that includes a novel flow control means that functions to control the flow of medicinal fluid from the fluid reservoir of the first sub-assembly toward the patient via strategically formed flow control passageways.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     Not applicable 
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     Not applicable 
     INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC 
     Not applicable 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates generally to fluid dispensing devices. More particularly, the invention concerns a novel dispenser for dispensing medicinal fluids, such as Bupivacane to ambulatory patients that uniquely comprises a flow rate control system that regulates the pressure of medicaments flowing to the patient. 
     2. Description of Related Art Including Information Disclosed Under 37 CFR 1.97 and 1.98 
     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. 
     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. 
     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, bio-pharmaceuticals, 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. 
     A more recent fluid dispensing apparatus invented by one of the named inventors of the present application is disclosed in U.S. Pat. No. 7,220,245. This apparatus comprises a compact fluid dispenser for use in controllably dispensing fluid medicaments, such as, antibiotics, oncolylotics, hormones, steroids, blood clotting agents, analgesics, and like medicinal agents from prefilled containers at a uniform rate. The dispenser uniquely includes a stored energy source that is provided in the form of a substantially constant-force, compressible-expandable wave spring that provides the force necessary to continuously and uniformly expel fluid from the device reservoir. The device further includes a fluid flow control assembly that precisely controls the flow of medicament solution to the patient. 
     BRIEF SUMMARY OF THE INVENTION 
     By way of brief summary, one form of the dispensing device of the present invention for dispensing pain management medicaments to a patient comprises first and second threadably interconnectable sub-assemblies. The first of these sub-assemblies houses a fluid reservoir defining component while the second comprises a fluid delivery and control assembly that includes a novel flow control means that functions to control the flow of medicinal fluid from the fluid reservoir of the first sub-assembly toward the patient via a plurality of fluid flow control passageways. 
     By way of brief background, the fluid dispensing system of the present invention has been created to provide safe and efficacious drug and fluid delivery in hospitals, surgery centers, home care, austere environments, and other alternate sites of care. The fluid delivery systems are uniquely configured for use at the point-of-care and will allow drug or fluid infusion to be initiated during virtually any phase of care, in any healthcare setting, and continue uninterrupted, while en-route to other medical facilities or during rehabilitation. 
     Additionally, the self-contained and therapy-specific nature of the fluid delivery systems functions to reduce the probability of costly and potentially life-threatening medication errors. In this regard, the fluid delivery systems of the invention are consistent with the growing trend of unit-dosing, where clinicians, pharmacists and regulators agree that a “unit of use” is the preferred form of containerization for liquid and solid medicines to be administered in hospital, home, or alternate site settings. Unit-dose packaging is preferred because of its inherent ability to reduce the possibility of medication error, while promoting the use of bar coding at the point of care. The unit-dose drug delivery dispensers of the present invention are also equally well suited for use in the inpatient hospital environment, where surgeries that are more complex require longer recovery times, or cannot be sustained in a surgicenter setting, are still performed. 
     With the forgoing in mind, it is an object of the present invention to provide a novel, safe and efficacious drug and fluid delivery system that can be efficiently used in hospitals, surgery centers, home care, austere environments, and other alternate sites of care 
     Another object of the invention is to provide a drug and fluid delivery system of the aforementioned character that is specifically configured for use at the point-of-care and one which will allow drug or fluid infusion to be initiated during virtually any phase of care, in any healthcare setting, and continue uninterrupted, while en-route to other medical facilities or during rehabilitation. 
     Another object of the invention is to provide a fluid dispensing system that can be used for controllably dispensing at a uniform rate a wide variety of fluid medicaments, such as Bupivacane, Ropivaciane, and Propofol and like medicinal. 
     Another object of the invention is to provide a pain management dispensing apparatus of the aforementioned character, of simple construction and one that can be used in the home care environment with a minimum amount of training. 
     Another object of the invention is to allow infusion therapy to be initiated quickly at the point of care without the assistance of a medical professional. 
     Another object of the invention is to provide a novel dispensing apparatus 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. 
     Another object of the invention is to provide a dispenser of the character described in the preceding paragraphs in which the stored energy source is provided in the form of a variable force spring that comprises a tightly coiled wound band of pre-hardened, perforated 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 variable rate. 
     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. 
     Another object of the invention is to provide a fluid dispensing apparatus that enables precise variable flow rate selection. 
     Another object of the invention is to provide a fluid dispensing apparatus of the character described in the preceding paragraphs that embodies an integrally formed, aseptically filled, unitary semi-rigid collapsible container that includes a fluid reservoir that contains the beneficial agents to be delivered to the patient. 
     Another object of the invention is to provide a fluid dispensing apparatus of the class described which is compact and lightweight, is easy for ambulatory patients to use and is extremely reliable in operation. 
     Another object of the invention is to provide a fluid dispensing apparatus that is easy and inexpensive to manufacture in large quantities. 
    
    
     
       BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS 
         FIG. 1  is a generally perspective view of one form of the fluid dispensing apparatus of the present invention. 
         FIG. 2  is a longitudinal cross-sectional view of a fluid dispensing apparatus shown in  FIG. 1  of the drawings. 
         FIG. 3  is a cross-sectional view taken along lines  3 - 3  of  FIG. 2 . 
         FIG. 4  is an enlarged cross-sectional view of the area designated as “ 4 ” In  FIG. 2 . 
         FIG. 5  is a generally perspective, exploded view of a fluid dispensing apparatus shown in  FIG. 1 . 
         FIG. 6  is a greatly enlarged cross-sectional view of the left-hand portion of the apparatus shown in  FIG. 2  of the drawings illustrating the construction of the carriage assembly of the invention. 
         FIG. 7  is a cross-sectional view taken along lines  7 - 7  of  FIG. 6 . 
         FIG. 8  is a top plan view of one form of the closed container of the apparatus of the invention. 
         FIG. 9  is a cross-sectional view taken along lines  9 - 9  of  FIG. 8 . 
         FIG. 10  is an enlarged, exploded view of the upper portion of the container shown in  FIG. 9  of the drawings. 
         FIG. 11  is a rear view of the spring housing front member of the apparatus. 
         FIG. 12  is a cross-sectional view taken along lines  12 - 12  of  FIG. 11 . 
         FIG. 13  is an enlarged cross-sectional view taken along lines  13 - 13  of  FIG. 14 . 
         FIG. 14  is a view taken along lines  14 - 14  of  FIG. 13 . 
         FIG. 15  is a view taken along lines  15 - 15  of  FIG. 13 . 
         FIG. 16  is a front view of the rate control advancement housing of the apparatus of the invention. 
         FIG. 16A  is a view taken along lines  16 A- 16 A of  FIG. 16 . 
         FIG. 17  is an enlarged cross-sectional view taken along lines  17 - 17  of  FIG. 16 . 
         FIG. 18  is a cross-sectional view taken along lines  18 - 18  of  FIG. 17 . 
         FIG. 19  is a cross-sectional view of one form of the rate control and advancement housing of the apparatus of the invention. 
         FIG. 20  is a cross-sectional, exploded view of the rate control and advancement housing shown in  FIG. 19 . 
         FIG. 20A  is a top view of one form of the penetrating assembly of the apparatus of the invention. 
         FIG. 20B  is a side view of  FIG. 20A . 
         FIG. 20C  is a view taken along lines  20 C- 20 C of  FIG. 20B . 
         FIG. 20D  is a view taken along lines  20 D- 20 D of  FIG. 20B . 
         FIG. 21  is an enlarged, generally perspective exploded view of the rate control and advancement housing shown in  FIG. 20 . 
         FIG. 22  is a cross-sectional view of one form of the rate control shaft of the rate control assembly of the apparatus of the invention. 
         FIG. 23  is a cross-sectional view taken along lines  23 - 23  of  FIG. 22 . 
         FIG. 24  is a view partly in cross section taken along lines  24 - 24  of  FIG. 22 . 
         FIG. 25  is a view taken along lines  25 - 25  of  FIG. 22 . 
         FIG. 26  is a view taken along lines  26 - 26  of  FIG. 22 . 
         FIG. 27  is a side elevational view of one form of the rate control cover of the rate control assembly of the apparatus of the invention. 
         FIG. 28  is a view taken along lines  28 - 28  of  FIG. 27 . 
         FIG. 29  is a top plan view of the rate control base of the rate control assembly of the apparatus of the invention. 
         FIG. 30  is a view taken along lines  30 - 30  of  FIG. 29 . 
         FIG. 31  is a longitudinal cross-sectional view similar to  FIG. 2 , but showing the multiple rate control assembly of the apparatus rotated into a forward position to expose the administration set. 
         FIG. 32  as a longitudinal cross-sectional view similar to  FIG. 31 , but showing the front housing rotated into a second position to place the apparatus in a fluid delivery configuration. 
         FIG. 33  is an enlarged cross-sectional view of the area designated as “ 33 ” in  FIG. 32 . 
         FIG. 34  is an enlarged fragmentary perspective front view of the apparatus shown in  FIG. 2  of the drawings illustrating the configuration of the rate control and disable mechanisms of the invention when the device is in a non-operating condition. 
         FIG. 35  is an enlarged fragmentary perspective front view of the apparatus shown in  FIG. 34  of the drawings illustrating the configuration of the rate control and disable mechanisms of the invention when the device is in an operating condition. 
         FIG. 36  is a generally perspective view of an alternate form of the fluid dispensing apparatus of the present invention. 
         FIG. 37  is a longitudinal cross-sectional view of a fluid dispensing apparatus shown in  FIG. 36  of the drawings. 
         FIG. 38  is a fragmentary cross-sectional view of the area designated as  38  in  FIG. 37 . 
         FIG. 38A  is a cross-sectional view taken along lines  38 A- 38 A of  FIG. 37 . 
         FIG. 39  is a generally perspective, exploded view of the fluid dispensing apparatus shown in  FIG. 36 . 
         FIG. 40  is a greatly enlarged cross-sectional view of the left-hand portion of the apparatus shown in  FIG. 37  of the drawings illustrating the construction of the carriage assembly of the invention. 
         FIG. 41  is a cross-sectional view taken along lines  41 - 41  of  FIG. 40 . 
         FIG. 42  is a top plan view of the closed container of this latest form of the invention. 
         FIG. 43  is a cross-sectional view taken along lines  43 - 43  of  FIG. 42 . 
         FIG. 44  is an enlarged, exploded view of the upper portion of the container shown in  FIG. 43  of the drawings. 
         FIG. 45  is an enlarged cross-sectional view taken along the lines  45 - 45  of  FIG. 46 . 
         FIG. 46  is a view taken along lines  46 - 46  of  FIG. 45 . 
         FIG. 47  is a view taken along lines  47 - 47  of  FIG. 45 . 
         FIG. 48  is a side elevational view partially in cross-section of the rate control advancement housing of this latest form of the invention. 
         FIG. 49  is a cross-sectional view taken along lines  49 - 49  of  FIG. 48 . 
         FIG. 50  is a view taken along lines  50 - 50  of  FIG. 48 . 
         FIG. 51  is a side elevational view of the rate control and advancement housing of this latest form of the invention. 
         FIG. 52  is a cross-sectional view taken along lines  52 - 52  of  FIG. 51 . 
         FIG. 53  is a view taken along lines  53 - 53  of  FIG. 51 . 
         FIG. 54  is a cross-sectional view taken along lines  54 - 54  of  FIG. 51 . 
         FIG. 55  is an enlarged, generally perspective exploded view of the rate control and advancement housing of this latest form of the invention. 
         FIG. 56  is a top plan view of the rate control and advancement housing of this latest form of the invention. 
         FIG. 57  is a side elevational view of the rate control and advancement housing shown in  FIG. 56 . 
         FIG. 58  is a cross-sectional view taken along lines  58 - 58  of  FIG. 57 . 
         FIG. 59  is a view partly in cross section taken along lines  59 - 59  of  FIG. 57 . 
         FIG. 60  is a side elevational view of the rate control assembly of this latest form of the invention. 
         FIG. 61  is a view taken along lines  61 - 61  of  FIG. 60 . 
         FIG. 62  is a side elevational view of the rate control cover of the rate control assembly shown in  FIG. 60 . 
         FIG. 63  is a view taken along lines  63 - 63  of  FIG. 62   
         FIG. 64  is a side elevational view of the rate control base of the rate control assembly. 
         FIG. 65  is a view taken along lines  65 - 65  of  FIG. 64 . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Definitions 
     As used herein the following terms mean: 
     Unitary Container: 
     A closed container formed from a single component. 
     Continuous/Uninterrupted Wall: 
     A wall having no break in uniformity or continuity. 
     Hermetically Sealed Container: 
     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. 
     Aseptic Processing: 
     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: 
     A sterile product is one that is free from all living organisms, whether in a vegetative or spore state. 
     Blow-Fill-Seal Process: 
     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. The process is 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. 
     Collapsible Container: 
     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. 
     Constant Force Spring: 
     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. 
     Modified Constant Force Spring (Variable Force Spring): 
     The modified constant force spring or variable force spring of the present invention comprises a spring of highly novel configuration that includes an elongated, pre-stressed strip of spring material that may be metal, a polymer, a plastic, or a composite material with built-in curvature so that, like the conventional constant force spring, each turn of the strip wraps tightly on its inner neighbor. Uniquely, in one form of the invention the elongated pre-stressed strip of spring material exhibits a cross-sectional mass that varies along said length. This variation in cross-sectional mass along the length of the spring can be achieved in various ways, as for example, by varying the width of the pre-stressed strip along its length and by providing spaced-apart apertures in the pre-stressed strip along its length. In another form of the invention, the pre-stressed strip of spring material is coiled about the spring drum to predetermined varying degrees of tightness. Accordingly, similar to the variable force spring having a variation in cross-sectional mass along the length of the spring, a variation of coil tightness can produce highly specific and desirable linear and non-linear force-distention curves. 
     Referring to the drawings and particularly to  FIGS. 1 and 2 , 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  38 . As best seen in  FIG. 2 , the fluid dispensing apparatus here comprises a first assembly  40  that includes an internally threaded first, or front housing  42  and an internally-externally threaded second or reservoir spring housing  44  connected to the internally threaded front housing  42 . Fluid dispensing apparatus  38  also includes a second assembly  46  that is connected to the internally-externally threaded reservoir spring housing  44  of the first assembly  40  by three circumferentially spaced locking tabs  48  ( FIG. 3 ). Located between the first and second assemblies  40  and  46  is a separator collar  50  and disposed between separator collar  50  and front housing  42  is a tear strip, or locking band  52 , the purpose of which will presently be described. 
     Housed within second assembly  46  and carried by a carriage  56  is a fluid reservoir defining component here shown as a hermetically sealed collapsible container  58 . Operably associated with the carriage  56  for moving it between a first retracted position shown in  FIG. 2  and a second advanced, fluid delivery position shown in  FIG. 32  is a novel stored energy means, the character of which will presently be described. As best seen by referring to  FIGS. 5 ,  6  and  7 , carriage  56  includes a base  56   a , an outwardly extending reservoir receiving body  56   b  and a plurality of spring securement subassemblies  56   c  that are connected the base  56   a . The details of construction of spring securement subassemblies  56   c  will be described in the paragraphs which follow. 
     As best seen in  FIGS. 2 ,  5  and  8  through  10 , reservoir defining component  58  here comprises an integrally formed, hermetically sealed container that includes a fluid medicament reservoir  60 . Integrally formed reservoir defining component  58  includes a front portion  58   a , a rear, inwardly extending, ullage defining wall portion  58   b  and a collapsible accordion-like, continuous, uninterrupted side wall  58   c  that interconnects the front and rear portion of the container. In a manner presently to be described, fluid medicament reservoir  60  is accessible via a penetrating member  62  which forms the inlet to the fluid delivery and control assembly of the invention, the character of which will presently be described. More particularly, penetrating member  62 , that forms a part of the penetrating housing of the invention, is adapted to pierce a top, or closure wall  64  of the reservoir defining component  58  as well as a pierceable septum  66  ( FIGS. 2 ,  8 ,  9  and  10 ) which is secured in position over closure wall  64  by means of a closure cap  70  that is affixed to the neck portion  58   a  of the reservoir defining component. 
     The reservoir defining component  60  is uniquely formed using an aseptic blow fill technique and the reservoir portion of the container is sealed by the thin closure or top wall  64 . The continuously formed top, bottom and accordion sidewalls cooperate to define sealed medicament reservoir  60 . Prior to heat sterilization of the container, the piercable septum  66  is positioned over the closure wall and the closure cap  70  is positioned over the piercable septum and is secured to the neck portion  58   a  by any suitable means such as adhesive bonding, sonic welding or heat welding. The container is held in position within housing  46  by means of a ring like member  74  that is disposed in engagement with internally-externally threaded reservoir spring housing  44  in the manner shown in  FIG. 2 . 
     Ring-like member  74  functions to partially support three circumferentially spaced spring carriage assemblies  76 , each of which houses a portion of the previously mentioned stored energy means of the invention ( FIG. 3 ). More particularly, the spring carriage assemblies  76  house the drum assemblies  80  of the stored energy means about which a portion of the elongated springs  82  of the stored energy means are wound. Spring carriage assemblies  76  form a part of the spring retaining means of the invention that functions to initially retain the variable force springs in their extended position and then, upon rotation of said first assembly  40  relative to said second assembly  46 , to permit said variable force springs to retract and in so doing move carriage  56  between the first retracted position shown in  FIG. 2  and the second advanced, fluid delivery position. 
     By way of background, conventional constant force springs are a special variety of extension spring. They comprise 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 (uncoiled), the inherent stress resists the loading force the same as a common extension spring, but at a nearly constant (zero) rate. 
     In the present form of the invention, the stored energy means comprises three variable force spring assemblies that are somewhat similar to the prior art constant force springs, but uniquely comprise assemblies, the details of which will presently be described, in which the elongated band or strip portion  82   a  of the spring  82  is coiled about the spring drum  80   b  in predetermined varying degrees of tightness. In this way, the springs can produce highly specific and desirable linear and non-linear force-distention curves to meet the fluid delivery requirements of the invention. 
     As best seen in  FIG. 2 , springs  82  are mounted with one end  82   b  tightly wrapped about drum assemblies  80  that are housed within spring carriage assemblies  76  and the other end  82   c  attached to carriage  56  by spring clamping members  56   c  in the manner shown in  FIGS. 2 ,  6  and  7 . 
     Referring particularly to  FIGS. 2 ,  3 ,  4  and  5  of the drawings, the configuration of the three identical, circumferentially spaced drum assemblies  80  is there illustrated. As indicated in  FIGS. 3 and 5 , each of the drum assemblies  80  is mounted within a selected one of the spring carriage assemblies  76  so that the shaft portion  80   c  of the drum assembly extends through openings provided in the side walls of the spring housings. More particularly, as indicated in the drawings, each of the sidewalls of each of the spring carriage assemblies  76  is provided with a generally rectangular shaped opening  88  and a smaller, generally rectangular shaped opening  90  that is in communication with the opening  88 . When the shaft portion  80   c  of the spring assembly extends through the smaller opening  90 , rotation of the drum is prevented. However, as will presently be discussed, when the spring housings are urged into a second, rearward position as a result of relative rotation of housings  42  and  44 , drum  80   b  is free to rotate so that the spring can be wound about the drum thereby urging the carriage  76  forwardly of the apparatus. 
     As previously mentioned, ring-like member  74  functions to partially support three circumferentially spaced spring carriage assemblies  76 . As indicated in the drawings, internally-externally threaded reservoir spring housing  44  also functions to partially support the three circumferentially spaced spring carriage assemblies  76 . In this regard, reservoir spring housing  44 , the details of construction of which are illustrated in  FIGS. 13 ,  14  and  15  of the drawings, is provided with a rearward body portion  44   a  to which the three circumferentially spaced locking tabs  48  are connected and a forward end currently-externally threaded reduced diameter portion  44   b . As best seen in  FIG. 14 , body portion  44   a  is provided with three circumferentially spaced cavities  45  within which portions of the spring carriage assemblies  76  are received. Body portion  44   a  is also provided with a central bore  47  that receives a portion of the important fluid delivery and control means of the invention. 
     Considering next the fluid delivery and control means of the invention, this important means, which functions to control the flow of fluid from the fluid reservoir of the collapsible container toward the patient, comprises a flow control assembly generally designated in the drawings by the numeral  94 . Assembly  94  includes a rate control advancement housing  96  the character of which is illustrated in  FIGS. 17 and 18 . Housing  96  includes an enlarged diameter finger gripping portion  96   a  and a reduced diameter, externally threaded portion  96   b . Externally threaded portion  96   b  is provided with central bore  99  which receives a penetrating assembly  102  that includes the previously identified penetrating member  62  that has a fluid passageway  62   a . Penetrating assembly  102  includes a body portion  102   a  having a fluid passageway  108  and a central bore  106   a  that rotatably receives a rate control shaft  110 . Rate control shaft  110  has a central fluid passageway  112  and a plurality of longitudinally spaced radial passageways  114   e ,  114   f ,  114   g  and  114   h  that communicate with central fluid passageway  112  ( FIGS. 23 and 25 ). Rate control shaft  110  also has an outwardly extending indexing tab  116  and a central bore  118  that are in communication with central fluid passageway  112 . Indexing tab is receivable within a groove  96   g , which is formed in the face of the adjacent housing, which groove is provided with circumferentially spaced indexing grooves  96   i . A plurality of O-rings  120  circumscribe the rate control shaft and sealably engage the inner wall of central bore  106   a  so as to prevent fluid leakage between the rate control shaft and body portion  106   a  of the penetrating assembly  102 . 
     As best seen in  FIG. 21 , body portion  102   a  of the penetrating assembly  102  is provided with a longitudinally extending, generally planar surface  122  that engages a generally planar shaped rate control plate  126  that forms a part of the important rate control means of the invention for controlling the rate of fluid flow toward the patient. Also forming a part of the rate control means of the invention is a rate control plate  126  that is covered by cover  124  in the manner illustrated in  FIGS. 20 and 21 . As shown in  FIG. 29 , rate control plate  126  is provided with an inlet  127  that communicates with a plurality of serpentine micro-channels  128   a ,  128   b ,  128   c  and  128   d  the purpose of which will presently be described. Micro-channels, which are controllably etched into the rate control plate  126 , are in communication with fluid passageway  108 . The length, width and depth of the micro-channels determine the rate at which the fluid will flow through the micro-channels toward the patient. 
     In using the apparatus of this latest form of the invention, the first step is to grip the enlarged diameter finger gripping portion  96   a  of housing  96  and rotate the housing from the position shown in  FIG. 2  of the drawings into the extended position shown in  FIG. 31  of the drawings. In this position, the administration line  134   a  of the administration set can be unwrapped from the body of the housing about which it has been coiled into the position shown in  FIG. 32  of the drawings. As shown in  FIG. 32 , the proximal end  133  of administration line  134   a  is connected to housing  96  by means of a connector  136 . Connector  136  is received within an opening  136   a  provided in housing  96  and within an opening  103  provided in penetrating housing  102 . As shown in  FIG. 20A , opening  103  communicates with bore  110   a  of rate control shaft  110 . Disposed between the proximal end  133  and the distal end  135  of the administration line is a conventional gas vent and filter  137  and a generally Y-shaped injector site, generally designated by the numeral  138 . A luer connector  140  of conventional construction is provided at the distal end  135  of the administration line. 
     After the administration line has been unfurled into the configuration shown in  FIG. 32 , the previously mentioned tear strip, or locking band  52 , is removed by pulling upwardly and outwardly on the locking band tab  52   a  (see  FIG. 1 ). Locking band  52  forms a part of the novel locking means of the invention which functions to prevent accidental relative rotation between front housing  42  and internally-externally threaded reservoir spring housing  44 . Removal of locking band  52  permits relative rotation between the first, or front, housing  42  and the reservoir spring housing  44  so as to cause the front housing  42  to move rearwardly into the position illustrated in  FIG. 32  of the drawings. As the front housing  42  moves rearwardly, the penetrating housing  102  will also move rearwardly causing the penetrating member  62  to penetrate elastomeric member, or pierceable septum  66  and closure wall  64  of the fluid reservoir defining component  60 , thereby opening communication between the fluid reservoir  60  and the internal passageway  62   a  of the penetrating member  62 . Penetrating housing  102  is provided with spaced apart O-rings “O” ( FIG. 2 ) to prevent fluid leakage between the moving components. 
     Rearward movement of the first housing  42  as a result of the relative rotational movement between the first, or front housing  42  and the reservoir spring housing  44  will cause shoulder  42   s  of first housing  42  to engage the three spring carriage assemblies  76  that house the drum assemblies  80  of the stored energy means and move them rearwardly from the position shown in  FIG. 31  and into the position shown in  FIG. 32  of the drawings. Movement of the drum assemblies into the position shown in  FIG. 32  will cause the release of the variable force springs  82 , which will cause the carriage  56  to advance to the position shown in  FIG. 32 , which, in turn, will cause the collapse of the fluid reservoir  60 . 
     With communication between the fluid reservoir  60  and the internal passageway  62   a  of the penetrating member  62  having been established, the fluid contained within the fluid reservoir will be expelled from the reservoir and the fluid will flow into the internal passageway  62   a  of the penetrating member  62 . From passageway  62   a , fluid will flow into passageway  108 , into passageway  133  and into inlet  127  of rate control plate  126  and then into the various circuitous fluid micro-channels  128   a ,  128   b ,  128   c  and  128   d  formed in the rate control plate (see  FIG. 29 ). As each of the micro-channels fills with the medicinal fluid to be dispensed to the patient, the fluid will flow next into outlet passageways  148   a ,  148   b ,  148   c  and  148   d , respectively formed in the rate control plate. Rate control plate  126 , which can be constructed from various plastics, is oriented relative to penetrating assembly  102  in the manner depicted in  FIG. 21  so that, as will presently be described, longitudinally spaced radial passageways  114   e ,  114   f ,  114   g  and  114   h  formed in rate control shaft  110  can communicate with outlet passageways  148   a ,  148   b ,  148   c  and  148   d  respectively. 
     As illustrated in  FIG. 21 , a slide lock  150  is carried within a “V” groove formed in a selector knob  152 . Upon advancement of the slide lock  150  into a selector knob locking position, the selector knob can be used to controllably rotate rate control shaft  110  so that a selected one of the plurality of longitudinally spaced radial passageways  114   e ,  114   f ,  114   g  and  114   h  formed in rate control shaft  110  can be brought into communication with a selected one of the outlet passageways  148   a ,  148   b ,  148   c  and  148   d  formed in the rate control plate. Since the central passageway  112  of the selector member is in fluid communication with the administration set  134  in the manner previously described, the fluid can be delivered to the patient at a selected controlled rate of flow. As best seen in  FIGS. 34 and 35 , the rate of fluid flow can be selected by rotating the selector knob to the desired flow rate indicated by the indicia  155  imprinted on the rate control indicator plate  158 ). 
     Considering now the important disable means of the invention for disabling the apparatus and preventing fluid flow from the reservoir of the device toward the administration set  134  via central passageway  112  of the selector member. In the present form of the invention, rate control shaft  110  of the rate control means is provided with a longitudinally extending bore  110   a  that slidably receives a disabling shaft  160  having an enlarged diameter head portion  160   a . As indicated in the drawings, when the disabling shaft  160  is pushed inwardly from the position shown in  FIG. 2  into an inward position, wherein it resides within a cavity  118  provided in the rate control shaft housing  110 , the forward portion  160   b  of the disabling shaft will move into a cavity  110   a  formed in rate control shaft  110  thereby blocking fluid flow from central passageway  112  toward the administration set and toward the patient. Forward travel of the disabling shaft is stopped when the head portion  160   a  seats within a cavity  152   a  formed in selector knobs  152  (see  FIG. 20 ). By stopping fluid flow in this manner, the apparatus is substantially safely disabled until the disabling shaft is once again returned to the starting position shown in  FIG. 2  of the drawings. 
     Turning now to  FIGS. 36 through 66 , an alternate form of the apparatus of the invention is there shown. This form of the apparatus is similar in many respects to the embodiment illustrated in  FIGS. 1 through 36  and like numerals are used in  36  through  66  to identify like components. The primary difference between this alternate embodiment of the invention and the earlier described embodiments resides in the differently configured fluid flow means. In this latest form of the invention, the fluid flow means comprises a fixed rate fluid flow means, rather than a variable rate fluid flow means as described in the embodiment of  FIGS. 1 through 36 . 
     Referring particularly to  FIGS. 36 through 40  of the drawings, this alternate form of the fluid dispensing apparatus of the invention for dispensing medicaments to a patient is generally designated by the numeral  170 . As best seen in  FIGS. 37 and 38 , as in the earlier described embodiment, fluid dispensing apparatus  170  here comprises an internally threaded first, or front housing  42 , an internally-externally threaded second or reservoir spring housing  44  connected to the internally threaded front housing  42  and a second assembly  46  connected to the internally-externally threaded reservoir spring housing  44  by three circumferentially spaced locking tabs  48  ( FIGS. 37 and 39 ). Disposed between front housing  42  and second assembly  46  is a separator collar  50 . Disposed between separator collar  50  and front housing  42  is a tear strip or locking band  52  that functions in the manner previously described. 
     Housed within second assembly  46  and carried by a carriage  56  is a fluid reservoir defining component, or hermetically sealed collapsible container  58 . Carriage  56  as well as collapsible container  58  are substantially identical in construction and operation to those previously described. Operably associated with the carriage  56  for moving it between a first retracted position shown in  FIG. 37  and a second advanced, fluid delivery position shown in  FIG. 68  is a novel stored energy means, which, as before, comprises three drum assemblies  80  about which a portion of three elongated springs  82  are wound. Elongated springs  82 , which are substantially identical in construction and operation to those previously described, comprise 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 (see  FIGS. 37 and 38 ). 
     As in the earlier described embodiment of the invention, the fluid medicament reservoir  60  of collapsible container  58  is accessible via a penetrating member  175  which forms the inlet to the fluid delivery and control assembly of the invention, the character of which will presently be described. More particularly, penetrating member  175 , which forms a part of the penetrating assembly  177  of the invention, is adapted to pierce a top, or closure wall  64  of the reservoir defining component  58  as well as a pierceable septum  66  ( FIGS. 43 and 44 ) which is secured in position over closure wall  64  by means of a closure cap  70  that is affixed to the neck portion  58   a  of the reservoir defining component. 
     As before, the reservoir defining component  58  is held in position within housing  46  by means of a ring like member  74  that is disposed in engagement with internally-externally threaded reservoir spring housing  44  in the manner shown in  FIG. 38 . Ring like member  74  functions to partially support three circumferentially spaced spring carriage assemblies  76 , each of which houses a portion of the previously mentioned stored energy means of the invention. More particularly, the spring carriage assemblies  76  house the drum assemblies  80  of the stored energy means about which a portion of the elongated springs  82  of the stored energy means are wound. The spring carriage assemblies  76  are also substantially identical in construction and operation to those previously described and, as previously discussed, when the spring housings are urged into a second, rearward position as a result of relative rotation of housings  42  and  44 , drum  82  is free to rotate so that the spring can be wound about the drum thereby urging the carriage  56  forwardly of the apparatus. 
     Considering next the fluid delivery and control means of this latest form of the invention, this important means, which functions to control the flow of fluid from the fluid reservoir of the collapsible container toward the patient, comprises a flow control assembly generally designated in the drawings by the numeral  177 . Assembly  177  includes a rate control advancement housing  96  that is substantially identical in construction and operation to that previously described. As before, rate control advancement housing  96  includes an enlarged diameter finger-gripping portion  96   a  and a reduced diameter externally threaded portion  96   b . Externally threaded portion  96   b  is provided with central bore  99  that receives a penetrating-rate control assembly  177  which includes penetrating component  177   a  having a fluid passageway  175   a  and a penetrating member  175  that has a fluid passageway  175   a  that is in communication with fluid passageway  178 . Penetrating-rate control assembly  177  also includes a rate control component  177   b  having a longitudinally extending, generally planar rate control plate receiving surface  180 , having a fluid outlet  181  that is in communication with fluid passageway  178  ( FIG. 56 ). 
     Penetrating rate control assembly  177  further includes the important rate control means of the invention for controlling the rate of fluid flow toward the patient. The rate control means of the invention here comprises a rate control plate  182  that is disposed in engagement with rate control plate receiving surface  180  of rate control cover  180   a . Rate control plate  182  is provided with a serpentine micro-channel  184  which is controllably etched into the rate control plate  182 . The length, width and depth of micro-channel  184  determine the rate at which the fluid will flow through the micro-channel toward the patient. Micro-channel  184  has an inlet  184   a  that is in communication with outlet  181  of rate control plate receiving surface  180  via a connector port  185   a  and an outlet  184   b  that is in communication with an inlet  188  formed in rate control plate receiving surface  180  via a connector port  185   b . Inlet  188  is, in turn, in communication the administration set  134  via an outlet passageway  190  formed in penetrating rate control assembly  177  ( FIG. 52 ). 
     The rate control component  177   b  of penetrating rate control assembly  177  is also provided with a central bore  192  that receives the disabling assembly  194  of this latest form of the invention. Disabling assembly  194  here comprises an elongated shaft  196  having a reduced diameter portion  196   a  and an enlarged diameter portion  196   b . Connected to enlarged diameter portion  196   b  is a pusher head  198  that enables the user of the device to push the disabling assembly inwardly from the position shown in  FIG. 68  of the drawings to an inward position wherein reduced diameter portion  196   a  enters a small bore  200  formed in rate control component  177  thereby blocking fluid flow through passageway  178  and in so doing disabling the apparatus. 
     In using the apparatus of this latest embodiment, after communication between the fluid reservoir  60  and the internal passageway  175   a  of penetrating member  175  has been established in the manner previously described by removing the tear strip and causing relative rotation between the front housing  42  and the reservoir spring housing  44 , the fluid contained within the fluid reservoir will be expelled from the reservoir and the fluid will flow into the internal passageway  175   a  of the penetrating member  175 . From passageway  175   a , fluid will flow into passageway  178  of penetrating assembly  177 , into inlet  184   a  of rate control fluid micro-channel  184 . The fluid will then flow at a controlled rate through micro-channel  184 , outwardly of outlet  184   b , into flow channel  190  and then onward to the patient via the administration set  134 . Once again, O-rings “O” are provided on the penetrating member as indicated in  FIG. 37 . 
     Having now described the invention in detail in accordance with the requirements of the patent statues, 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.