Abstract:
A dispensing device for dispensing pain management medicaments to a patient comprising first and second threadably interconnectable sub-assemblies. The first of these sub-assemblies houses a novel collapsible 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 collapsible reservoir defining component toward the patient via a plurality of fluid 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, Propofol and like medicinals. 
     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 system of the present invention. 
         FIG. 2  is a generally perspective view of the body portion of the form of the fluid dispensing system shown in  FIG. 1 . 
         FIG. 3  is a generally perspective view similar to  FIG. 2 , but illustrating the manner of operation of the device to enable initiation of fluid flow toward the patient. 
         FIG. 4  is a generally perspective view similar to  FIG. 3 , illustrating the manner of operation of the device to initiate fluid flow toward the patient. 
         FIG. 5  is a longitudinal cross-sectional view of the body portion of the fluid dispensing system shown in  FIG. 2  of the drawings. 
         FIG. 6  is a longitudinal cross-sectional view of the body portion of the fluid dispensing system similar to that shown in  FIG. 5  of the drawings, but illustrating the position of the various components of the device following the fluid delivery step. 
         FIG. 7  is a fragmentary, longitudinal cross-sectional view similar to  FIG. 2 , but showing only the configuration of the base portion of the device. 
         FIG. 8  is a cross-sectional view taken along lines  8 - 8  of  FIG. 7 . 
         FIG. 9  is a view taken along lines  9 - 9  of  FIG. 10 . 
         FIG. 10  is a cross-sectional view taken along lines  10 - 10  of  FIG. 9 . 
         FIG. 11  is a cross-sectional view taken along lines  11 - 11  of  FIG. 10 . 
         FIG. 12  is a generally perspective rear view of the plunger housing of the device that is mounted within the rear housing of the device shown in the left-hand portion  FIG. 1 . 
         FIG. 13  is a generally perspective front view of the plunger housing. 
         FIG. 14  is a generally perspective exploded view of the plunger housing shown in  FIG. 13 . 
         FIG. 15  is a cross-sectional, exploded view of the plunger housing shown in  FIG. 14 . 
         FIG. 16  is a view taken along lines  16 - 16  of  FIG. 15 . 
         FIG. 17  is a cross-sectional view of the plunger housing of  FIG. 15  shown in an assembled configuration. 
         FIG. 18  is a view taken along lines  18 - 18  of  FIG. 17 . 
         FIG. 19  is a view taken along lines  19 - 19  of  FIG. 17 . 
         FIG. 20  is a top plan view of one form of the hermetically sealed collapsible container of the invention that is mounted within the rear housing of the device. 
         FIG. 21  is a cross-sectional view taken along lines  21 - 21  of  FIG. 20 . 
         FIG. 22  is an enlarged, fragmentary exploded view of the upper portion of the collapsible container shown in  FIG. 21 . 
         FIG. 23  is a top plan view of the main dispenser substrate of the apparatus of the invention shown in the central portion of  FIG. 5  of the drawings. 
         FIG. 24  is a cross-sectional view taken along lines  24 - 24  of  FIG. 23 . 
         FIG. 25  is a view taken along lines  25 - 25  of  FIG. 24 . 
         FIG. 26  is a view taken along lines  26 - 26  of  FIG. 24 . 
         FIG. 27  is a top plan view of the rear housing of the apparatus as shown in the rear portion of  FIG. 1  and within which the reservoir plunger assembly and the collapsible container of the invention is mounted. 
         FIG. 28  is a cross-sectional view taken along lines  28 - 28  of  FIG. 27 . 
         FIG. 29  is a view taken along lines  29 - 29  of  FIG. 27 . 
         FIG. 30  is a view taken along lines  30 - 30  of  FIG. 27 . 
         FIG. 31  is a fragmentary cross-sectional view taken along lines  31 - 31  of  FIG. 28 . 
         FIG. 32  is a front view of the front housing of the apparatus of the invention shown in the right-hand portion of  FIG. 1  and within which said rate control means of the invention is mounted. 
         FIG. 33  is a cross-sectional view taken along lines  33 - 33  of  FIG. 32 . 
         FIG. 34  is a view taken along lines  34 - 34  of  FIG. 33 . 
         FIG. 35  is a top plan view of the internally threaded housing portion of the apparatus disposed immediately rearwardly of the housing assembly shown in  FIG. 33 . 
         FIG. 36  is a cross-sectional view taken along lines  36 - 36  of  FIG. 35 . 
         FIG. 37  is a view taken along lines  37 - 37  of  FIG. 36 . 
         FIG. 38  is a view taken along lines  38 - 38  of  FIG. 36 . 
         FIG. 39  is a top plan view of the rate control assembly of the apparatus of the invention shown in  FIG. 5 . 
         FIG. 40  is a cross-sectional view taken along lines  40 - 40  of  FIG. 39 . 
         FIG. 41  is a view taken along lines  41 - 41  of  FIG. 40 . 
         FIG. 42  is a cross-sectional view of the rate control base of the rate control assembly shown in  FIG. 39 . 
         FIG. 43  is a top plan view of one form of the rate control plate of the rate control means of the apparatus of the invention. 
         FIG. 44  is a view taken along lines  44 - 44  of  FIG. 43 . 
         FIG. 45  is a top plan view of the rate control plate housing of the rate control means of the apparatus of the invention. 
         FIG. 46  is a cross-sectional view taken along lines  46 - 46  of  FIG. 45 . 
         FIG. 47  is a view taken along lines  47 - 47  of  FIG. 46 . 
         FIG. 48  is a longitudinal cross-sectional view of the body portion of an alternate form of the fluid dispensing system of the invention. 
         FIG. 49  is a longitudinal cross-sectional view of the body portion of the fluid dispensing system similar to that shown in  FIG. 48  of the drawings, but illustrating the position of the various components of the device following the fluid delivery step. 
         FIG. 50  is a top plan view of an alternate form of the hermetically sealed collapsible container of the invention that is mounted within the rear housing of the device illustrated in  FIG. 48 . 
         FIG. 51  is a cross-sectional view taken along lines  51 - 51  of  FIG. 50 . 
         FIG. 52  is an enlarged, fragmentary exploded view of the upper portion of the collapsible container shown in  FIG. 51 . 
     
    
    
     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. 
     Referring to the drawings and particularly to  FIGS. 1 through 5 , one form of the fluid dispensing apparatus of the present invention for dispensing medicaments to a patient is there shown and generally designated in  FIG. 1  by the numeral  40 . As indicated in  FIG. 4 , the fluid dispensing apparatus here comprises a front or first housing  42  and a rear, or second housing  44  that is connected to the first housing. As will be described in greater detail hereinafter, when the apparatus is in the configuration shown in  FIG. 1 , no fluid can flow toward the patient. However, upon operation of the rotatable housing lock  45  of the apparatus, rotation of the front and rear housings relative to one another from a first position to a second position can be accomplished in the manner indicated in  FIG. 4  of the drawings thereby rendering the device operable so as to permit fluid flow toward the patient. 
     Interconnected with and closing the rear portion of rear housing  44  is an internally threaded dispenser base  46 . Formed in the upper surface of rear housing  44  is an indicator window  48 , the purpose of which will presently be described (see also  FIG. 8 ). Base  46  is provided with a plurality of circumferentially spaced apart cavities  50  that locate and support four circumferentially spaced container guides  52  that function to position the collapsible container of the invention within the rear housing and to guide its forward travel in the manner illustrated in  FIG. 5  of the drawings. As illustrated in  FIGS. 9 and 11 , base  46  is also provided with a plurality of anti-rotational teeth  54  that function to prevent rotation of the dispenser base relative to the rear housing  44 . 
     Disposed internally of the rear housing is the important plunger assembly  56 , the character of which is illustrated in  FIGS. 12 through 18  of the drawings. Plunger assembly  56  comprises a rear or first plunger housing  58  and a front or second plunger housing  60  that is interconnected with the rear housing  58  by mating locking tabs. More particularly, rear plunger housing  58  is provided with a plurality of circumferentially spaced, forwardly extending locking tabs  62 , while front plunger housing  60  is provided with a plurality of circumferentially spaced, rearwardly the extending locking tabs  64 . When the front and rear plunger housings are interconnected in the manner shown in  FIG. 17  of the drawings, the teeth-like end portions  59  of the locking tabs are in locking engagement. However, upon relative rotation of the front and rear housings in a manner presently to be described, the teeth-like end portions of the locking tabs will move out of engagement with one another thereby permitting a spring  66 , which is housed within rear housing  58 , to urge the front plunger housing  60  forwardly in the manner illustrated in  FIG. 15  from a first position to a second position. As best seen by referring to  FIG. 15 , locking tabs  62  cooperate with inwardly extending projections  68 , which are formed on the interior of rear plunger housing  58 , to form a spring locating and receiving channel  70  that locates and receives the rearward extremity of spring  66  (see  FIG. 17 ). Rear plunger housing  58  is also provided with a plurality of circumferentially spaced apart openings  71  that receive the previously mentioned container guides  52  that form a part of the important main dispenser substrate  73  of the invention ( FIGS. 23 and 24 ). As best seen in  FIGS. 5 and 6  of the drawings, housing  44  is interconnected with the main dispenser substrate  73  by means of circumferentially spaced apart housing locking tabs  75 . 
     Front plunger housing  60  is provided with an outwardly extending fluid indicator tab  72 , the purpose of which will presently be described, and a plurality of guide tabs  74  ( FIGS. 12 ,  13 ,  14 ) that are received within a plurality of circumferentially spaced apart guide grooves  75  formed in housing  44  ( FIG. 7 ) and function to guide forward travel of the forward plunger housing  60  within rear housing  44 . Front plunger housing  60  is also provided with a generally cylindrically shaped cavity  76  ( FIG. 14 ) that receives the reservoir guides  52 . 
     As previously mentioned, received within the circumferentially spaced reservoir guides  52  is the important hermetically sealed collapsible container, or fluid reservoir defining component  80 . As best seen in  FIGS. 20 ,  21  and  22 , container  80  includes a front neck portion  80   a , a rear, inwardly extending, ullage defining wall portion  80   b  and a collapsible accordion-like, continuous, uninterrupted side wall  80   c  that interconnects the front and rear portion of the container and cooperates therewith to define a fluid reservoir  82 . As illustrated in  FIG. 21 , ullage defining wall portion  80   b  has a length “L” that is approximately ⅓ the depth “D” of the fluid reservoir  82 . In a manner presently to be described, fluid medicament reservoir  82  is accessible via a piercing member  84  ( FIGS. 5 and 6 ) which forms the inlet to the fluid delivery and control assembly of the invention, the character of which will presently be described. More particularly, piercing member  84  is adapted to pierce a top, or closure wall  80   d  of the collapsible container  80  as well as a pierceable septum  86  ( FIGS. 21 and 22 ) which is secured in position over closure wall  80   d  by means of a closure cap  88 , which is affixed to the neck portion  80   a  of the reservoir defining component. 
     The reservoir defining component, or collapsible container  80 , 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  80   d . The continuous top, bottom and accordion side walls cooperate to define the sealed medicament reservoir  82 . Prior to heat sterilization of the container, the piercable septum  86  is positioned over the closure wall and the closure cap  88  is positioned over the piercable septum and is secured to the neck portion  80   a  by any suitable means such as adhesive bonding, sonic welding or heat welding. The container  80  is held in position within housing  44  by the front plunger housing  60 , the dispenser substrate  73  and the circumferentially spaced reservoir guides  52 . 
     Piercing member  84  forms a part of and provides the inlet to the fluid delivery and control assembly  90  of the invention that is housed within housing  42 . In addition to piercing member  84 , fluid delivery and control assembly  90  includes an externally threaded rate control base  92  ( FIGS. 39 ,  40  and  42 ) and an externally threaded rate control cover  94  ( FIGS. 39 ,  40 ) that is interconnected with rate control base  92 . Rate control base  92  is provided with a rate control cavity  92   a  ( FIG. 42 ) that houses the novel fluid flow rate control assembly  96  that functions to control the rate of flow of medicinal fluid toward the patient. As depicted in  FIG. 5  of the drawings, rate control assembly  90  is threadably interconnected through an internally threaded sleeve  95  ( FIGS. 35 and 36 ) carried within housing  42  and upon relative rotation of housings  42  and  44 , is movable from the retracted position shown in  FIG. 5  to the advanced position shown in  FIG. 6 . 
     As best seen in  FIGS. 43 through 47 , fluid flow rate control assembly  96  comprises a generally planar shaped rate control plate  98 , which as shown in  FIG. 43  is provided with a serpentine micro-channel  100  having an inlet  100   a  and an outlet  100   b . Micro channel  100  which is controllably etched into rate control plate  98 , communicates with an inlet port  102  and with an outlet port  104  formed in rate control cover plate  106  ( FIGS. 46 and 47 ). Cover plate  106  cooperates with rate control plate  98  to define a fluid passageway  107  ( FIG. 5 ), the length, width and depth of which determines the rate at which the fluid will flow from inlet port  102  toward outlet port  104 . 
     As shown in  FIGS. 5 and 6  of the drawings, inlet port  102  communicates with the internal passageway  84   a  of penetrating member  84  via a passageway  107  formed in rate control base  92 . Outlet port  104  communicates with the administration line  108  of a conventional administration set  110  via a passageway  112  formed in rate control base  92 . Administration line  108  is sealably interconnected with an outlet port  114  formed on the front housing assembly  116  of the invention which is connected to sleeve  95  carried in front housing  42  in the manner illustrated in  FIG. 5  of the drawings. Front housing assembly  116  comprises a body portion  116   a  having a rearwardly extending tubular portion  116   b  that is telescopically receivable within a forwardly extending tubular extension  90   a  formed on the fluid delivery and control assembly  90  ( FIGS. 40 and 42 ). A conventional O-ring  117  ( FIG. 33 ) is carried by rearwardly extending tubular portion  116   b  and functions to prevent fluid leakage between the tubular portion  116   b  and the tubular extension  90   a . With the construction thus described, the proximal end  108   a  of the administration line is in communication via passageway  112  with an outlet fluid passageway  120  formed in front housing assembly  116 . 
     Body portion  116   a  of front housing assembly  116  is covered by a co-molded elastomer  116   c  within which a plurality of administration line-receiving grooves  122  are formed. During transport and storage of the dispensing device of the invention, the administration line can be conveniently coiled about the front housing assembly  116  so that it resides within the administration line receiving grooves  122 . 
     As illustrated in  FIG. 1  of the drawings, disposed between the proximal end  108   a  and the distal end  108   b  of the administration line are a conventional clamp  124 , a conventional gas vent and filter  126 , and a generally Y-shaped injector site, generally designated by the numeral  128 . A luer connector  130  of conventional construction is provided at the distal end  108   b  of the administration line. 
     In using the apparatus of this latest form of the invention, the first step is to uncoil the administration line  108  from the front housing assembly so that the administration set is unfurled in the manner shown in  FIG. 1  of the drawings. This done, the locking means of the invention is then operated. This novel locking means functions to prevent accidental relative rotation between the first and second assemblies  42  and  44 . In the present form of the invention, the locking means comprises the previously identified rotatable housing lock  45  that extends into the main dispenser substrate  73  in the manner shown in  FIG. 5  of the drawings. Rotation of the housing lock  45  and its removal from the main dispenser substrate in the manner illustrated in  FIG. 6  of the drawings, permits relative rotation between housings  42  and  44 . 
     Upon relative rotation of housings  42  and  44 , fluid delivery and control assembly  90  will advance along the threads  42   a  provided on control assembly  90 , into the position illustrated in  FIG. 6  of the drawings. As control assembly  90  advances, penetrating member  84  will penetrate elastomeric member, or pierceable septum  86  and closure wall  80   d  of the collapsible container  80 . Advance of control assembly  90  will also cause tubular portion  116   b  of front housing assembly  116  to telescope forwardly of extension  90   a  of control assembly  90  in the manner shown in  FIG. 6  of the drawings. 
     Relative rotation of housings  42  and  44  will also cause the locking tabs  59  formed on rear plunger housing  58  and a front plunger housing  60  to disengage, thereby permitting spring  62  to urge the front plunger housing  60  to move forwardly of housing  44 . As the front plunger housing moves forwardly, the collapsible container constrained between the advancing front plunger housing  60  and the dispenser substrate  73  will collapse in the manner illustrated in  FIG. 6  of the drawings. 
     Communication between the fluid reservoir  82  and the internal passageway  84   a  of the penetrating member  84  having been established by the rearward movement of the fluid and delivery control assembly  90 , the fluid contained within the fluid reservoir will be expelled from the reservoir  82  as a result of the forward movement of the front plunger housing  60 , collapsing container wall  80   c.    
     From the internal passageway  84   a  of penetrating member  84 , the fluid will flow toward longitudinally extending fluid passageway  107  and then into inlet port  102  formed in rate control housing  106 . Next, the fluid will flow into the inlet  100   a  of the serpentine micro-channel  100 , through the micro channel  100  at a controlled rate, through the outlet  100   b  of the micro channel, into outlet port  104 , into passageway  120  and finally into the administration set  40  for delivery to the patient at a precisely controlled rate, depending upon the configuration of the micro-channel  100 . 
     In order that the caregiver can continuously monitor the amount of fluid remaining within the fluid reservoir  82 , indicator means are provided for indicating the volume of fluid contained within the reservoir. In the present form of the invention, this indicator means comprises the previously identified fluid indicator tab  72  of front plunger housing  60  and the fluid indicator window  48  provided in housing  44  that enables the caregiver to view the fluid reservoir  82 . Indicia  48   a  imprinted on the fluid indicator window ( FIGS. 1 through 3 ) along with forward movement of the fluid indicator tab  72 , provides an accurate indication of the volume of fluid contained within the reservoir. 
     Turning now to  FIGS. 48 through 52 , 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 47  and like numerals are used in  FIGS. 48 through 52  to identify like components. The primary difference between this alternate embodiment of the invention and the earlier described embodiments resides in the differently configured reservoir defining assembly  134 . As best seen in  FIG. 51 , reservoir defining assembly  134  comprises telescoping portions  136 ,  138 ,  140  and  142  that cooperate to define a fluid medicament reservoir  144 . More particularly, upper portion  136  is constructed and arranged so as to be telescopically received within intermediate portion  138 . Similarly, portion  140  is constructed and arranged to be telescopically received within portion  138  and lower portion  142  is constructed and arranged to be telescopically received within intermediate portion  140  (see  FIG. 49 ). 
     Upper portion  136  of the collapsible container  134  is sealed by a closure wall  136   a , while lower portion  142  is closed by a bottom wall  142   a  that includes an inwardly extending ullage defining portion  142   b . As in the earlier described embodiment of the invention, fluid medicament reservoir  144  is accessible via a penetrating member  84  which forms the inlet to the fluid delivery and control assembly of the invention, which is substantially identical in construction and operation to that previously described. More particularly, penetrating member  84  is adapted to pierce a top, or closure wall  136   a  of the collapsible container  134  as well as a pierceable septum  146  ( FIGS. 51 and 52 ) which is secured in position over closure wall  136   a  by means of a closure cap  148  which is affixed to portion  136  of the reservoir defining component. 
     As in the earlier described embodiments of the invention, this latest apparatus comprises relatively rotatable front and rear housings  42  and  44  that are substantially identical in construction and operation to the housings previously described. Disposed internally of rear housing  44  is the important plunger housing  56 , which is also substantially identical in construction to the previously described. As indicated in the drawings, penetrating member  84  is housed within housing  42 . In addition to penetrating member  84 , fluid delivery and control assembly  90  includes an externally threaded rate control base  92  ( FIGS. 39 ,  40  and  42 ) and an externally threaded rate control cover  94  ( FIG. 42 ) that is interconnected with rate control base  92 . Rate control assembly  90  is also substantially identical in construction and operation to that previously described and includes the novel fluid flow rate control assembly  96  that functions to control the rate of flow of medicinal fluid toward the patient. As in the earlier described embodiment of the invention, rate control assembly  90  is threadably interconnected through sleeve  95  with housing  42  and upon relative rotation of housings  42  and  44 , is movable from the retracted position shown in  FIG. 48  to the advanced position shown in  FIG. 49 . 
     The fluid flow rate control assembly  96  of this latest form of the invention comprises a generally planar shaped rate control plate  98 , which as shown in  FIG. 43  is provided with a serpentine micro-channel  100  having an inlet  100   a  and an outlet  100   b . Micro-channel  100  which is controllably etched into rate control plate  198 , communicates with an inlet port  102  and with an outlet port  104  formed in a rate control housing  106  ( FIGS. 46 and 47 ). The length, width and depth of the micro-channel determine the rate at which the fluid will flow from inlet port  102  toward outlet port  104 . 
     As shown in  FIGS. 48 and 49  of the drawings, inlet port  102  communicates with the internal passageway  84   a  of penetrating member  84  via passageway  107 . Outlet port  104  communicates with the administration line  108  of a conventional administration set  110  via a passageway  112  formed in rate control base  92 . Administration line  108  is sealably interconnected with an outlet port  114  formed on the front housing assembly  116  of the invention which is connected to housing  94  in the manner illustrated in  FIG. 48  of the drawings. 
     In using the apparatus of this latest form of the invention, the first step is to uncoil the administration line  108  from the front housing assembly so that the administration set is unfurled in the manner shown in  FIG. 1  of the drawings. This done, the locking means of the invention is then operated to permit relative rotation between housings  42  and  44 . 
     Upon relative rotation of housings  42  and  44 , fluid delivery and control assembly  90  will advance along the threads  42   a  provided on assembly  90 , into the position illustrated in  FIG. 49  of the drawings. As assembly  90  advances, penetrating member  84  will penetrate elastomeric member, or pierceable septum  146  and closure wall  136   a  of the collapsible container  134 . Advance of assembly  90  will also cause tubular portion  116   b  of front housing assembly  116  to telescope forwardly of extension  90   a  of assembly  90  in the manner shown in  FIG. 48  of the drawings. 
     Relative rotation of housings  42  and  44  will also cause the locking tabs  59  formed on rear plunger housing  58  and a front plunger housing  60  to disengage, thereby permitting spring  62  to urge the front plunger housing  60  to move forwardly of housing  44 . As the front plunger housing moves forwardly, the collapsible container will collapse in the manner illustrated in  FIG. 49  of the drawings. 
     Communication between the fluid reservoir  57  and the internal passageway  84   a  of the penetrating member  84  having been established by the rearward movement of the fluid and delivery control assembly  90 , the fluid contained within the fluid reservoir  144  will be expelled from the reservoir as a result of the forward movement of the front plunger housing  60 . 
     From the internal passageway  84   a  of penetrating member  84 , the fluid will flow toward longitudinally extending fluid passageway  107  and then into inlet port  102  formed in rate control housing  106 . Next, the fluid will flow into the inlet  100   a  of the serpentine micro-channel  100 , through the micro channel  100  at a controlled rate, through the outlet  100   b  of the micro channel, into outlet port  104 , into passageway  120  and finally into the administration set  40  for delivery to the patient at a precisely controlled rate depending upon the configuration of the micro-channel  100 . 
     As before, so that the caregiver can continuously monitor the amount of fluid remaining within the fluid reservoir  82 , indicator means are provided for indicating the volume of fluid contained within the reservoir. 
     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.