WO1998026834A1

WO1998026834A1 - Fluid delivery apparatus

Info

Publication number: WO1998026834A1
Application number: PCT/US1997/023604
Authority: WO
Inventors: Marshall S. Kriesel; Steven M. Arnold; James Garrison; Farhad Kazemzadeh
Original assignee: Science Incorporated
Priority date: 1996-12-18
Filing date: 1997-12-18
Publication date: 1998-06-25
Also published as: AU5803698A; EP1007144A4; EP1007144A1

Abstract

This invention is an apparatus (30) for accurately infusing medicinal agents into an ambulatory patient at specific rates over extended periods of time. The apparatus (30) is of a compact, low profile, laminate construction, and includes an elastic distending membrane (34), a chamber (46) having a fluid outlet (52). Disposed within the fluid chamber (46) is a thin fluid permeable member (66) which precisely controls the rate of fluid flow through the fluid outlet (52). The apparatus (30) also includes a highly novel fluid flow indicator (100) that provides a readily discernible visible indication of fluid flow through the apparatus (30). Additionally, the apparatus (30) includes a fill assembly (150d) comprising a prefilled vial (170) that can be used to fill the fluid reservoir (46) of the device (30) with a selected medicinal fluid.

Description

FLUID DELIVERY APPARATUS

S P E C I F I C A T I O N

Background of The Invention

This is a Continuation-In-Part Application of co-pending Application, Serial No. 08/432,221, filed May 1, 1995; which is a Continuation-In-Part Application of Application, Serial No. 08/046,438 filed May 18, 1993 which has now issued into Patent No. 5,411,480; which is a Continuation-In-Part of Application Serial No. 07/987,021 filed December 7, 1992 which has now issued into Patent No. 5,279,558; which is a Continuation-In-Part of Application 07/870,269 which has now issued into Patent No. 5,205,820; and which is, in turn, a Continuation-In-Part of Application Serial No. 07/642,208 which has now issued into U.S. Patent No. 5,169,389; which is a Continuation-In-Part of Application Serial No. 07/367,304 filed June 16, 1989 which has now issued into U.S. Patent No. 5,019,047 Field of The Invention -

The present invention relates generally to fluid delivery devices. More particularly, the invention concerns an improved apparatus, including visual flow indicator means and a novel vial assembly reservoir filling means for infusing medicinal agents into an ambulatory patient at specific rates over extended periods of time.

Discussion of The Invention

Many medicinal agents require an intravenous route for administration thus bypassing the digestive system and precluding degradation by the catalytic enzymes in the digestive tract and the liver. The use of more potent medications at elevated concentrations has also increased the need for accuracy in controlling the delivery of such drugs. The delivery device, while not an active pharmacologic agent, may enhance the activity of the drug by mediating its therapeutic effectiveness. Certain classes of new pharmacologic agents possess a very narrow range of therapeutic effectiveness, for instance, too small a dose results in no effect, while too great a dose results in toxic reaction.

In the past, prolonged infusion of fluids has generally been accomplished using gravity flow methods, which typically involve the use of intravenous administration sets and the familiar bottle suspended above the patient. Such methods are cumbersome, imprecise and require bed confinement of the patient. Periodic monitoring of the apparatus by the nurse or doctor is required to detect malfunctions of the infusion apparatus.

Devices from which liquid is expelled from a relatively thick-walled bladder by internal stresses within the distended bladder are well-known in the prior art. Such bladder, or "balloon" type, devices are described in U.S. Patent No. 3,469,578, issued to Bierman and in U.S. Patent No. 4,318,400, issued to Perry. The devices of the aforementioned patents also disclose the use of fluid flow restrictors external of the bladder for regulating the rate of fluid flow from the bladder.

The prior art bladder type infusion devices are not without drawbacks. Generally, because of the very nature of bladder or "balloon" configuration, the devices are unwieldy and are difficult and expensive to manufacture and use. Further, the devices are somewhat unrelieble and their fluid discharge rates are frequently imprecise.

The apparatus of the present invention overcomes many of the drawbacks of the prior art by eliminating the bladder and making use of recently developed elastomeric films and similar materials, which, in cooperation with a base define a fluid chamber that contains the fluid which is to be dispensed. The elastomeric film membrane controllably forces fluid within the chamber into fluid flow channels provided in the base.

The elastomeric film materials used in the apparatus of the present invention, as well as various alternate constructions of the apparatus, are described in detail in U. S. Patent No. 5,205,820 issued to the present inventor. Therefore, U.S. Patent No. 5,205,820 is hereby incorporated by reference in its entirety as though fully set forth herein. Co-pending USSN 08/046,438 filed by the present inventor on May 18, 1993 also describes various alternate constructions and modified physical embodiments of the invention. This co-pending application is also hereby incorporated by reference in its entirety as though fully set forth herein.

The apparatus of the present invention can be used with minimal professional assistance in an alternate health care environment, such as the home. By way of example, devices of the invention can be comfortably and conveniently removably affixed to the patient's body and can be used for the continuous infusion of antibiotics, hormones, steroids, blood clotting agents, analgesics, and like medicinal agents. Similarly, the devices can be used for I-V chemotherapy and can accurately deliver fluids to the patient in precisely the correct quantities and at extended microfusion rates over time. One of the embodiments of the invention described in Continuation-In-Part application Serial No. 08/046,438 includes a highly novel, laminate stored energy means made up of a plurality of individual membranes. As before, this unique stored energy means cooperates with the base to define one or more fluid reservoirs or chambers. However, by constructing the stored energy means from a composite of several elements or layers, the elastic characteristics of the stored energy means can be precisely tailored and the stored energy means can be uniquely constructed to function also as a gas permeability valve as well as the means for expelling fluids from the fluid reservoir. This unique, multilayered or gradient construction may permit venting to atmosphere through the membrane surface certain selected, entrained gases or vapors in the reservoir while simultaneously precluding any negative migration of selected atmospheric gases or vapors into the reservoir. Where the composite is made up of two or more layers of alternating thickness and permeability, and the permeability constants of the individual film layers are pressure dependent, the permeability of the stored energy means is effected and the αirection of flow of the permiant through the membrane wall is controlled by the order in which the individual layers or gradations of the composite are assembled.

The embodiments of the invention described in Serial No. 08/046, 438 also include an embodiment wherein the rate of fluid flowing from the dispensing means of the device is controlled by flow control means disposed intermediate the reservoir outlet and the fluid dispensing port of the device. More particularly, the flow rate control means comprises a fluid flow micro-conduit and a porous member which functions to restrict the flow of fluid between the outlet and the dispensing port. The embodiments of the invention described herein include different forms of flow control means and also include novel flow identification means.

Summary of The Invention

It is an object of the present invention to provide an apparatus for expelling fluids at a precisely controlled rate which is of a compact, low profile, laminate construction. More particularly, it is an object of the invention to provide such an apparatus which can be used for the precise infusion of pharmaceutical fluids to an ambulatory patient at controlled rates ever extended periods of time.

It is another object of the invention z provide an apparatus of the aforementioned character which is highly reliable and easy-to-use by lay persons in a non-hospital environment.

Another object of the invention is to provide an apparatus which can be factory prefilled with a wide variety of medicinal fluids or one which can readily be filled in the field shortly prior to use.

A further object of the invention is to provide a low profile, fluid delivery device of laminate construction which can be manufactured inexpensively in large volume by automated machinery. Another object of the invention is to provide a device of the aforementioned character which includes a novel rate control membrane disposed intermediate the fluid reservoir outlet and the outlet port of the device.

Another object of the invention is to provide a device of the character described which embodies a highly novel fluid flow indicator that provides a readily discernible visual indication of fluid flow status through the device.

Anotner object of the invention is to proviαe an apparatus of the aforementioned character in which the stored energy source is of a novel laminate construction which can oe precisely tailored to deliver fluid from the device at precise rates.

Another object of the invention is to provide a unique fill assembly for use in controllably filling the fluid reservoir of t-.e apparatus.

Another object of the present invention is to provide an -pDaratus of the aforementioned character in which the f ll asseroly comprises a vial assembly that can be prefilled with a wide variety of medicinal fluids.

Another object of the present invention is to provide a fill assembly of tne type described in the preceding oaragraph in «N/hιc- tne prefilled vial assembly is partially received within the housing of tne fluid dispensing device for operable mtercon- τect_on therewith.

Anotner object of the invention is to provide an apparatus as αescribed in the preceding paragraphs which includes looting means for locking the vial assembly to the fluid delivery assenoly following filling of the fluid reservoir.

Another object of the invention is to provide a novel vial assemoly for use with the fluid dispenser subassembly of the apparatus which is easy to use, is inexpensive to manufacture, and one /hich maintains the vial in an aseptic condition until time of use .

Gtner objects of the invention are set forth in U. S. present form of the invention comprises four cooperating subas- semblies, namely a reservoir assembly, a fluid flow control subassembly, a flow indicator subassembly and a reservoir fill assembly. The reservoir subassembly, which readily lends itself to automated manufacture, is generally similar to that described in copending Serial No. 08/046,438 and includes a base and a stored energy means comprising at least one distendable elastomeric membrane which cooperates with the base to form a fluid reservoir. The fluid flow control subassembly is also similar to that described in Serial No. 08/046,438 in that it comprises a thin permeable flow control membrane which controls the rate of flow of fluid flowing toward the outlet port of the device.

However, in the present embodiment of the invention, the flow control membrane is not disposed within the reservoir, but rather resides exteriorly thereof. The highly novel fluid flow indicator means of the invention comprises a mechanical fluid flow indicator that provides a clear visual indication of normal fluid flow and absence of fluid flow either because the reservoir is empty or because the flow lines are occluded. More particularly, symbols indicating the operating condition of the device are produced by the movement of thin, indicia-carrying films. These films, which comprise a part of the flow indicator means, are shifted by the movement of mechanical actuators which are deflected solely by the fluid pressure within the device. The fluid flow indicator design does not invade the fluid flow path and yet utilizes the same stored energy means to generate fluid pressure that provides for the normal functioning of the device. The fluid flow indicator is highly reliable in operation, can be produced inexpensively, and, because it has very few parts, is easy to and yet utilizes the same stored energy means to generate fliiiα pressure that provides for the normal functioning of the device. The fluid flow indicator is highly reliable in operation, can be produced inexpensively, and, because it has very few parts, is easy to manufacture.

The novel fill assembly for use in filling the reservoir of the reservoir assembly comprises a novel vial assembly which can be operably mated with the reservoir assembly.

Brief Description of The Drawings

Figure 1 is a generally perspective top view of one form of the fluid delivery apparatus of the invention.

Figure 2 is a generally perspective, bottom view of the apparatus shown in Figure 1.

Figure 3A is a generally perspective, exploded view of the downstream portion of one form of the fluid dispensing apparatus of the invention showing the flow indicator means and a portion of the flow control means.

Figure 3B is a generally perspective, exploded view of the remainder of the flow control means along with the reservoir subassembly portion of one form of the fluid dispenser apparatus of the invention shown in Figures 1 and 2.

Figure 3C is a generally perspective, fragmentary view of a portion of the distendable membrane assembly of the apparatus.

Figure 3D is a generally perspective, exploded view of the fluid flow control assembly illustrating its laminate con- struction.

Figure 4 is a top plan view of the apparatus, partly broken away to show internal construction.

Figure 5 is a cross-sectional view taken along lines 5-5 of Figure 4.

Figure 6 is a cross-sectional view taken along lines 6-6 of Figure 5.

Figure 7 is a cross-sectional view taken along lines 7-7 of Figure 5.

Figure 8 is a view of the apparatus taken along lines 8-8 of Figure 5.

Figure 9 is a cross-sectional view taken along lines 9-9 of Figure 8.

Figure 10 is a cross-sectional view taken along lines 10-10 of Figure 8.

Figure 11 is a cross-sectional view taken along lines 11-11 of Figure 8.

Figure 12 is a generally perspective, exploded view of one form of forward housing portion of the apparatus of the invention which is also shown on the left-hand portion of Figure 3.

Figure 13 is a front view of the housing portion. Figure 14 is a cross-sectional view taken along lines 14-14 of Figure 13.

Figure 15 is a generally perspective view of the cover for the rate control apparatus of the invention.

Figure 16 is a generally perspective, front view of the substrate portion of the rate control apparatus.

Figure 17 is a generally perspective rear view of the substrate portion.

Figure 18 is a generally perspective view of the output port of the apparatus.

Figure 19 is a front view of the output port shown in Figure 18.

Figure 20 is a cross-sectional view taken along lines 20-20 of Figure 19.

Figure 21 is a front view of the luer valve fitting of the apparatus.

Figure 22 is a cross-sectional view taken along lines 22-22 of Figure 21.

Figure 23 is an enlarged plan view of the indicia carrying thin films of the apparatus of the invention.

Figure 24 is a cross-sectional view similar to Figure 14 showing the indicator means of the invention in its starting configuration.

Figure 25 is a fragmentary plan view of the symbol that is viewable by the user when the apparatus is in the configuration shown in Figure 24.

Figure 26 is a cross-sectional view similar to Figure 24 but showing the indicator means as it appears when fluid is flowing through the apparatus in a normal fashion.

Figure 27 is a fragmentary plan view of the symbol that is viewable by the user when the apparatus is in the configuration shown in Figure 26.

Figure 28 is a cross-sectional view similar to Figure 24, but showing the indicator means as it appears when there is a blockage downstream of the indicator means that prevents normal fluid flow. Figure 29 is a fragmentary plan view of the symbol that is viewable by the user when the apparatus is in the configuration shown in Figure 28.

Figure 30 is an exploded, generally perspective bottom view of still another form of the apparatus of the invention in which the reservoir of the fluid delivery device is filled by a vial assembly of novel construction.

Figure 31 is a side-elevational, cross-sectional, exploded view of the vial assembly of the apparatus shown in Figure 30.

Figure 32 is a side-elevational, cross-sectional view of the apparatus of Figure 30 showing the vial assembly coupled with the reservoir assembly of the fluid delivery device.

Figure 32A is a generally perspective exploded view of the sterile cover subassembly of the invention for closing the vial assembly receiving chamber of the fluid delivery device.

Figure 33 is an enlarged, generally perspective, exploded view of the vial assembly receiving chamber of the reservoir assembly showing the vial assembly in position to be mated with the reservoir assembly.

Figure 34 is a cross-sectional view taken along lines 34-34 of Figure 32.

Figure 34A is a fragmentary, cross-sectional view of the area designated 34A in Figure 34.

Figure 35 is a fragmentary, cross-sectional view similar to Figure 34 but showing an alternate form of membrane capture means .

Figure 36 is a side-elevational view of an alternate form of reservoir fill assembly. Figure 37 is a generally perspective bottom view illustrating the manner of filling the reservoir using the reservoir fill assembly shown in Figure 36.

Figure 38 is a side-elevational, cross-sectional, exploded view showing an alternate form of the apparatus of the invention in which the blunt end cannula of the reservoir assembly has been replaced with a needle like piercing cannula.

Figure 39 is a side-elevational, cross-sectional view of an apparatus similar to that depicted in Figure 32 but showing an alternate form of reservoir fill assembly that uniquely embodies an adapter subassembly that permits a vial assembly having a needle-type pierceable septum to be mated with a reservoir assembly such as shown in Figure 32 which has a blunt end cannula.

Figure 40 is an enlarged fragmentary, cross-sectional view of a proportion of the adapter subassembly shown in Figure 39 with a portion of a vial assembly having a needle piercing cannula mated therewith.

Figure 41 is a generally perspective, exploded view of one form of the flow control and flow indicator means of the invention.

Figure 42 is a generally perspective, exploded view similar to Figure 41 also illustrating the construction of the alternate form of flow control and indicator means of the invention.

Figure 42A is a generally perspective view of one form of the elastomeric boot component of the indicator means of the invention which, in response to fluid pressure, acts upon the indicia carrying means of the flow indicating means.

Figure 42B is a fragmentary, generally perspective view illustrating an alternate form of flow control means of the invention.

Figure 42C is a fragmentary, generally perspective view illustrating yet another form of flow control means of the invention.

Figure 43 is a fragmentary, side-elevational, cross-sectional view of still another form of reservoir assembly of an alternate embodiment of the invention.

Figure 44 is a fragmentary, side-elevational, cross-sectional view similar to Figure 39, but showing the fill means of this alternate form of the invention being mated with the reservoir assembly.

Figure 45 is an enlarged, cross-sectional view taken along lines 45-45 of Figure 44.

Figure 46 is a generally perspective bottom view of an alternate form of the fluid delivery apparatus of the invention.

Figure 47 is a generally perspective, top view of the apparatus shown in Figure 46.

Figure 48 is a fragmentary, cross-sectional view of the forward portion of the form of the fluid dispensing apparatus shown in Figure 47.

Figure 49 is a front view of the apparatus showing the closure means of the invention in an open configuration.

Figure 50 is a cross-sectional view taken along lines 50-50 of Figure 49.

Figure 51 is a cross-sectional view taken along lines 51-51 of Figure 49.

Figure 52 is an enlarged, exploded, cross-sectional view of the fluid flow control means of this latest form of the invention.

Figure 53 is a view of the flow control means of Figure 52 shown as an assembled configuration.

Figure 54 is an exploded, generally perspective front view of the support structure of the fluid delivery apparatus of the form of the invention shown in Figures 46 and 47.

Figure 54A is an exploded, generally perspective, rear view of the apparatus shown in Figure 54.

Figure 55 is a generally perspective bottom view of still another form of the apparatus of the invention.

Figure 56 is a generally perspective, top view of the apparatus shown in Figure 55_.

Figure 57 is a front view of the fluid dispensing apparatus shown in Figure 56.

Figure 58 is a cross-sectional view taken along lines 58-58 of Figure 57.

Figure 59 is a fragmentary, cross-sectional view taken along lines 59-59 of Figure 57 showing the forward portion of the flu a delivery apparatus.

Figure 60 is a fragmentary top view of the forward portion of this latest form of the invention showing the circum- ferentially extending recess which is provided for delivery line storage.

Description of the Invention

Referring to the drawings and particularly to Figures 1 through 7, the apparatus of this latest form of the present invention is there illustrated and identified generally by the numeral 30. As best seen in Figures 3A and 3B, the apparatus comprises three major cooperating subassemblies namely, a reservoir subassembly, a flow rate control subassembly, and a flow indicator subassembly. These subassemblies will be discussed in detail in the paragraphs which follow.

Considering first the reservoir subassembly shown in Figure 3B, this subassembly is similar in many respects to that described in Serial No. 08/046,438 and includes a base assembly 32, a stored energy source, or distendable membrane assembly 34, and a cover 36 for enclosing the stored energy source and the base assembly (see also Figures 1 and 2) . The base assembly includes an ullage substrate 38 and a membrane capture housing 40 having a bottom opening 42 which receives the distendable membrane engaging element or protuberance 44 (see also Figure 5) .

Referring particularly to Figures 3B and 5, the ullage substrate 38 comprises, in addition to the distendable member engaging protuberance, or ullage, 44, filling means which enables filling of the fluid reservoir which is formed between protu berance 44 and distended membrane 34. This filling means here comprises a fluid inlet 48 provided in a luer valve fitting 50, the character of which will presently be described. Protuberance 44 is provided with a longitudinally extending fluid passageway 52 (Figure 3B) which communicates with fluid passageways 54 and 56 provided in the base portion 38a of ullage substrate 38 (see also Figures 5 and 7) .

Base portion 38a of ullage substrate 38 also includes an upstanding tongue 60 which extends about the perimeter of the base portion and is closely receivable within a groove 62 formed in the base of membrane capture housing 40 (Figure 5) . When the ullage substrate and the membrane capture housing are assembled in the manner shown in Figure 5, the periphery of distendable membrane assembly 34 will be securely clamped within groove 62 by tongue 60. After the parts are thus assembled, housing 40 is bonded to substrate 38 by any suitable means such as adhesive or sonic bonding. This done, cover 36 is mated with housing 40 in the manner shown in Figure 5 and bonded in place. Cover 36 is preferably constructed from a substantially transparent plastic material which is impermeable to fluids, including gases.

The apparatus of this latest embodiment of the invention is adapted to be filled with the selected medicinal fluid either at time of manufacture or in the field as may be desired. Filling is accomplished by introducing fluid under pressure into inlet passageway 48 and thence into reservoir 46 via luer fitting 50. As the fluid under pressure flows into the reservoir, it will cause membrane assemDly 34 to distend outwardly from protuberance 44 in the manner shown in Figure 5. Luer fitting 50 includes a skirt portion 50a, a valve seat 50b and a biasing spring 50c (see alsc Figure 22) . Receivable into valve seat 50b is a ball check valve 68 which will lift from seat 50b against tne urging of spring 50c during reservoir filling, but will sealably engage seat 50b after the reservoir has been filled. Inlet 48 is closed by a closure cap 51 prior to and following the filling step.

While the stored energy means can be in the form of a single prestressed or unstressed isotropic, elastomeric distendable membrane, it is here shown as a laminate assemblage made up of a plurality of initially generally planar distendable elements or films. Referring particularly to Figure 3C, the stored energy means can be seen to comprise a laminate assemblage 34 made up of individual layers 34a, 34b, 34c, 34d, 34e, and 34f. Assemblage 34, which is typically prestressed, functions in much the same way as the distendable membranes described in Serial No. 08/046,438 and cooperates with ullage substrate 38 to define a fluid chamber, or reservoir 46. However, by constructing the stored energy means from a composite of distinct elements or layers, the elastic characteristics of the stored energy means can be precisely tailored in the manner described in Serial No. 08/046,438. As previously discussed, as the distendable membrane assemblage 34 is distended by the fluid pressure exerted by the fluid flowing into inlet 48, internal stresses are formed therein which continuously urge the assemblage toward engagement with protuberance 44 as it tends to return toward its original configuration. As the assemblage moves toward protuberance 44, fluid within reservoir 46 will be uniformly and controllably forced outwardly through longitudinally extending passageway 52 in protuberance 44 and then into passageways 54 and 56 of portion 38a of ullage substrate 38. For certain applications it is desirable to provide on one or more layers of the membrane assemblage a surface which is specifically designed to be compatible with the fluid to be delivered. For example, layer 34e can be provided cn its underside with a compatibility layer 34f constructed from a co-polyester sold by DuPont under the name and style of HYTREL.

Reference should be made to United States Serial No. 08/046,438 for the various materials that can be used to construct the base assembly, the cover and the membrane assemblage identified in the preceding paragraphs.

Turning next to a consideration of the flow rate control subassembly of this latest form of the invention, this subassembly includes novel flow control means which are disposed externally of reservoir 46 for controlling the rate of fluid flow of fluid from the device. In the embodiment of the invention shown in Figures 3A through 7, the flow control means comprises a rate control membrane 66 (Figure 3A) which is closely received within a circular recess 68 formed in support means shown here as a membrane support structure 70. The downstream wall 72 of recess 68 is provided with fluid distribution means comprising a multiplicity of circumferentially spaced, manifolding stand-off elements 74 against which membrane 66 is held in engagement by a disc-like member 76 (Figure 3B) which is receivable within recess 68 (see also Figures 16 and 17). As best seen by also referring to Figures 12 and 15, member 76 is provided with fluid collection means shown here as a multiplicity of circumferentially spaced, manifolding stand-offs 78 which engage membrane 66 when member 76 is in position within cavity 68. More particularly, as indicated in Figure 14, when member 76 is in place within cavity 68, the flow control membrane 66 is bonded at its circumference to member 70 and is securely positioned between stand-offs 74 and 78 which cooperate to define a multiplicity of concentric and radial extending fluid passageways, which function to direct fluid flow through the flow control means. Air within chamber 68 is vented via vent patch 79a and opening 79b (Figures 3B and 12) .

As shown in Figure 3D, flow control 66 here comprises a laminate construction made up of layers 66a, 66b, 66c, 66d, 66e, and 66f. More particularly, layer 66a comprises first filter for initially filtering the fluid, while layer 66b comprises a second filter for providing a second, more refined, filtering of the fluid. Layer 66c is here shown as a first flow rate control membrane for controlling flow at a first rate. Layer 66e is a second flow rate control membrane for controlling flow at a second rate. Disposed intermediate rate control membranes or layers 66c and 66e is a distribution means or porous distribution layer for distributing the fluid flowing through membrane 66c across the surface of membrane 66e. Layer 66f comprises a porous support member for supporting membrane 66e.

First and second filters 66a and 66b can be constructed from polyether sulfone sold by Gel an Sciences under the name and style of SUPOR.

Flow rate control layers 66c and 66e can be constructed from a porous polycarbonate material available from Poretics Corporation or from Corning Costar Corporation. The distribution or separation layer can be constructed from polypropylene available from Gelman Sciences. It is preferable that the surface and orifice chemistry of each layer of the flow control 66 be rendered hydrophillic.

As best seen in Figures 3B and 15, member 76 includes a downwardly extending fluid inlet leg or segment 80 which is provided with a fluid passageway 82. Passageway 82 is adapted to communicate with chamber 68 when member 76 is mated with support structure 70. As best seen in Figure 16, support structure 70 has a centrally disposed recess 84 that receives inlet segment 80.

Formed on either side of recess 84 are wing-like protuberances 86 that are received within spaced-apart, arcuate-shaped cavities 88 formed in the base portion 38a of ullage substrate 38. Also formed in substrate 38 is a socket 91 (Figure 7) which closely receives a tubular extension 92 formed as a part of inlet segment 80 (Figure 15) . Located proximate the upper edge of support structure 70 are spaced-apart capture grooves 96, which attach cover 36 to member 70.

As shown in Figure 5, when the flow control subassembly is mated with the reservoir assembly, fluid inlet passageway 82 of member 76 is placed in fluid communication with reservoir46 via passageways 54 and 56. With this construction, when fluid is forced through fluid passageway 52 of protuberance 44 by the stored energy means, the fluid will flow into passageway 54, next into passageway 56, then into passageway 82 of member 76, and finally into chamber 68 formed in member 70. As the fluid under pressure flows into the upstream portion of chamber 68 behind membrane 66, it will be distributed by stand-offs 78 so that it will uniformly flow through membrane 66 and toward the fluid outlet port of the flow control subassembly. As best seen in Figures 12 and 18, the outlet port comprises an assembly 87 which is receivable in a cavity 73 formed in the back of downstream wall 70c of substrate 70. Assembly 87 includes a fluid outlet 90 and an internal chamber 92, with actuator fill port 92a the purpose of which will presently be described.

The flow control means can also comprise an assemblage of a plurality of layers of permeable materials, ?-l, P-2, and P-3 of the character seen in Figure 31 of U. S. Patent No. 5,205,820. These layers, which may be composites, thin films, or porous substrates, may be constructed of any one of the materials described in U.S. Patent No. 5,205,820 so that the fluid pressure flow characteristics of the assemblage can be precisely tailored for the particular medicinal or other fluid being dispensed. Reference should be made to U. S. Patent No. 5, 205,820 for a further description of the construction and operation of the flow control membrane. Considering now the flow indicator means of the invention, this novel means visually distinguishes among three conditions of operation, namely normal fluid flow, fluid flow blockage or occlusion, and reservoir empty. Turning to Figure 3A, the flow indicator means here comprises an indicator base or platform 100, a support or lens plate 102, and a hollow housing 104 within which the platform and the support plate are mounted. As seen in Figure 12, plate 102 has a viewing lens 102a which indexes with an aperture 104a provided in housing 104.

Disposed between platform 100 and plate 102 are first and second indicia-carrying means shown here as thin films. These films identified here as 106 and 108, are in intimate contact and are constructed from a substantially transparent, flexible polymer material such as mylar. The indicia-carrying means need not be thin films, but rather can be any type of surface presenting member upon which indicia can be provided. The downstream surface of the inferior or first film 106 is printed with three integrated symbols 107 (Figure 23), namely, a blue circle 107a (Figure 25), a green arrow 107b (Figure 27), and a red X 107c (Figure 29), each consisting of diagonal stripes of color printed in an alternating pattern (blue, green, red, blue, green red, and so on) . (Figures 23 through 29) . The superior, or second film 108 serves as a "mask" over the inferior film 106 and is printed with a pattern of diagonal alternating clear and opaque strips 108a that occur in a 1:2 ratio. The printed ratio of the superior "mask" allows only one colored symbol to appear at a time when viewed through viewing lens 102a in plate 102. The inferior and superior films are provided at their opposite ends with apertures 110 which receive retention pins 112 provided on platform 100 (Figure 12) which permit attachment of the film to platform 100 in a manner such that the non-patterned portions of each film covers actuator slots 114 and 116 provided proximate each end of platform 100 with the patterned portions of both the superior and inferior films being maintained in the index. With this construction, each thin film is able to move in opposing directions parallel to the film plane with its range of motion limited to one axis in the film plane by edge guides 118 provided on platform 100 (Figure 12). As the films move, the visible symbol pattern changes due to the transverse displacement of the patterns imprinted thereon.

Referring particularly to Figures 3A, 9 and 14, it can be seen that support plate 102 is provided with transversely spaced, channel-like depressions 120 and 122 which index with slots 114 and 116 respectively when the components are assembled in the manner shown in Figures 9 and 14. Aligned with the upstream side of slots 114 and 116 are mechanical actuator means, here provided as mecnanical actuators or elastomeric elements 124 and 126. More particularly the first actuator element 124 aligns with slot 114 and the second actuator element 126 aligns with slot 116.

In a manner presently to be described, the mechanical actuator means are deflected from their initial configuration whenever there is sufficient fluid pressure present within the fluid flow path to cause their outward deflection toward thin films 106 and 108. During operation the first mechanical actuator element 124 is deflected by fluid pressure of reservoir 46. More particularly, when there is sufficient fluid pressure in the fluid reservoir and fluid is being delivered by the stored energy means of the device, the first mechanical actuator means is deflected outwardly so as to urge the non-patterned portion 109 of indicator film 108 into expansion channel 122. As the film arches into channel 122, the printed portion of the film is transversely displaced a specific distance. This film displacement re-aligns the printed symbol patterns on the inferior film 106 with the mask pattern on the superior film 108 and results in a change of the symbol (in this case an arrow) that is visible through the support plate view aperture I02a (see Figures 1, 26 and 27) .

As can be observed by referring to Figures 28 and 29, both the first and second mechanical elastomeric actuator elements 124 and 126 are inflated and deflected outwardly toward their respective extension channels when the device is filled and primed but not in a state of delivery or when there is a build up of fluid pressure during delivery that is caused by blockage of the delivery line downstream from second mechanical actuator element 126. While element 124 can be deflected by normal line pressure, element 126 is deflected only by pressure buildup resulting from the downstream blockage. When both mechanical actuators are deflected outwardly, both the superior and inferior films are displaced transversely to a second position revealing a second symbol, as for example, an X as viewed through the viewing aperture of the support plate (see Figures 28 and 29) .

A third alignment of symbol patterns as shown in Figures 24 and 25 is visible when the device is in an unfilled state or when the delivery line is open, the reservoir is empty and fluid delivery to the patient has been completed. In this case, there is no fluid pressure in the line on either the upstream or downstream side of the flow control means and thus both the first and second mechanical actuator elements are in a non-deflected position . In this condition, the inferior and superior films are not transversely displaced and thus exhibit a third combination of patterns resulting in a third symbol as , for example , a circle being visible through the viewing aperture of the support plate (see Figure 25 ) . Actuating elements 124 and 126 can be precisely tailored to deflect under various pressures thereby permitting great apparatus versatility.

In considering the method of operation of the device and the manner in which fluid flow through the device , reference should be made particularly to Figures 5 , 10 , and 12 . During the filling step, the fluid to be dispensed is introduced into reservoir 46 via a fluid inlet conduit 49a ( Figure 1 ) which is connected to luer fitting 50 . Fluid flowing into the fitting lifts check valve ball 68 against the urging of spring 5Cc and causes the distendable membrane assembly to be displaced away from ullage protuberance 44 in the manner shown in Figure 5. Air within housing 40 and cover 36 will be suitably vented to atmosphere via a vent 41 which is receivable within a vent aperture 41a provided in housing 40 ( Figure 3B) . During the filling step , the gaseous component of the f luid is vented to atmosphere via a vent patch 43 provided in portion 38a of substrate 38 ( Figures 3B and 5 ) .

During the fluid dispensing step, the prestressed membrane assembly will tend to return toward a less distended configuration causing fluid within the reservoir to flow outwardly of passageway 52 and into passageways 54 and 56. The fluid under pressure will next flow into passageway 82 of disc-shaped member 76. Turning particularly to Figures 15 and 16, it is to be observed that a portion of the f luid entering chamber 68 of member ^"70 from passageway 82 and upstream of membrane 66 can by pass flow rate control member 66 and flow directly toward an ear-shaped extension 76a (Figure 15) provided on member ^"6 via flow passageways 76b and 76c. From passageway 76c, the fluid will flow under pressure into a passageway 70a formed in substrate 70 and toward passageway outlet 70b. Referring also to Figure 17, it is to be noted that passageway 70a extends through a protuberance 71 formed on end wall 70c of substrate 70. This construction permits the fluid flowing into ear-shaped protuberance 76a to flow through passageway 70a and impinge directly upon flow indicator element 124 which sealably engages the protuberance, causing it to deform outv:ardly in a manner to force portion 109 of indicator film 108 to arch into expansion channel 122 (Figure 26) . This, in turn, will cause transverse displacement of indicator film 108 in the manner previously described.

As indicated in Figure 28, fluid flowing through passageway 82 of disc-shaped member 76 will also be distributed over the upstream face of the rate control membrane 66 by the fluid distribution means, or protuberances 78 and will pass through the membrane at a predetermined controlled rate. The fluid flowing through the rate control membrane will be collected by the fluid collection means or protuberance 74 and then will flow via passageway 85 into passageway 92a of outlet port assembly 87 (Figure 19) . The fluid will then flow outwardly of the device through fluid outlet 90 to which an infusion line 93 is connected. (Figures 1, 18, 19, and 20). It is to be observed that a portion of the fluid flowing into outlet port assembly 87 is free to flow through a passageway 92a provided in a protruding portion 87a thereof. If there is a blockage which prevents continued free fluid flow outwardly of the device through outlet 90 and infusion line 93, fluid, under pressure, F-2 will impinge upon indicator element 126 causing it to deflect outwardly in the manner shown in Figure 28. This outward deflection of element 126 will urge a portion of indicator film 106 into receiving channel 120 of the lens plate causing transverse movement of film 106 so as to reposition film 106 relative to film 108. Should fluid flow into chamber 92 cease, indicator element 126 will return to its at-rest position as will film 106. Similarly, if fluid flow from the reservoir ceases, film 108 will also return to its at rest position thereby once again causing the "0" symbol to be viewable thrcugh the viewing lens.

Turning next to Figures 30 through 34, another form of the apparatus of the invention is there shown and generally identified by a numeral 150. As best seen in Figures 30 and 32, the apparatus here comprises four major cooperating subassemblies namely, a reservoir subassembly 150a, a flow rate control subassembly 150b, a flow indicator subassembly 150c and a fill assembly 150c. Each of these subassemblies will be discussed in greater detail in the paragraphs which follow.

Considering first the reservoir subassembly shown in Figure 32, this subassembly includes a base assembly 152, a stored energy source, shown here as a distendable membrane component 154, and a cover 156 for enclosing the stored energy source. The base assembly includes an ullage substrate 158 and a membrane capture housing 160 having a bottom opening 162 which receives the distendable membrane engaging element or protuberance 164 (see also Figure 34) of base assembly 152.

Referring particularly to Figures 32 and 34, the ullage substrate 158 is provided with fill assembly receiving means shown here as a longitudinally extending, generally cylindrically shaped receiving chamber 165 for receiving the fill assembly 150d. Provided within chamber 165 are the valve and cannula means of the invention, the nature and purpose of which will presently be discussed. As best seen by referring to Figure 30 and 31, one form of the fill assembly 150d of the apparatus comprises a container subassembly 170 and an adapter subassembly 172. Container subassembly 170 includes a body portion 176, having a fluid chamber 178 for containing an injectable fluid. Chamber 178 is provided with first and second open ends 180 and 182 (Figure 31) . First open end 130 is sealably closed by closure means here provided in the form of a pierceable septum assembly 184 which includes a septum 184a. Septum 184a is pierceable by the cannula means of the invention which is shown in Figures 32 and 33 as a blunt end, hollow cannula 185. Septum assembly 184 is held securely in position within open end 180 by clamping ring 186. As best seen in Figure 31 and 32, to expel fluid from chamber 178, a plunger 188 is telescopically movable within the chamber from a first location where it is proximate second open end 182 to a second position shown in Figure 32 where it is proximate first open end 180. The vial or body portion of the container subassembly 170 can be constructed of various materials such as glass and plastic.

Referring particularly to Figure 31, it can be seen that the adapter subassembly 172 of this form of the invention comprises a hollow housing 190 in the manner shown in having a first open end 192 and a second closed end 194. Container subassembly 170 is telescopically receivable within open end 192 of housing 190 in the manner shown in the drawings so that the housing can be moved from the first extended position shown in Figure 30 to the vial encapsulation position shown in Figure 32. Forming an important part of the adapter subassembly is pusher means shown here as an elongated pusher rod 196 which functions to move plunger 188 within fluid chamber 178 from the first position shown in Figure 30 to the second position shown in Figure 32. In the form of the invention shown in the drawings, pusher rod 196 has a first end 196a interconnected with closure wall 194 and an opposite end 196b which engages plunger 188 and causes telescopic movement of the plunger within chamber 178 of container subassembly 170 as housing 190 is moved from the extended position shown in Figure 30 into the vial encapsulating position shown in Figure 32.

As best seen by referring to Figures 30 and 32, receivable within the mouth 165a of chamber 165 of substrate 158 is a retaining ring 191 having an alignment protuberance 197 which engages and centers adapter subassembly 172 within chamber 165. Due to the small surface area presented by protuberance 197, there is little frictional resistance to the sliding movement of the adapter subassembly relative to base assembly 152 as the adapter subassembly is moved from the extended position shown in Figure 30 into the vial encapsulating position shown in Figure 32.

Turning particularly to Figures 30, 32, and 32a, it is to be noted that prior to the fill assembly being inserted into chamber 165, the chamber is maintained in a sterile condition by a sterile tear-off cover assemble 200 which is bonded or otherwise removably affixed to retaining ring 191. An integral pull tab 200a is provided to permit the tear-off cover 200b to be pulled from retaining ring 191 so as to permit insertion of the fill assembly into chamber 165. Assembly 200 also includes a resilient tab-like element 200c (Figure 32A) which lockably engages saw tooth-like protuberances 190a formed on adapter subassembly 172 to prevent removal of the adapter subassembly from cha ber 165 after it has been fully inserted therewithin. As best seen in Figure 30, a medicament label 204 circumscribes adapter portion 172 and serves to identify tne contents of container subassembly 170 prior to mating the fill assembly with the dispensing device. It is also to be noted that container subassembly 170 is provided with a plurality of spaced-apart index lines 206, which, by viewing the container assembly tnrough a window 207 provided n substrate 158 (Figure 30), permit tne user to determine how much fluid remains within the container at any given time.

As plunger 188 is moved forwardly of container 170 by the insertion of tne fill assembly into chamber 165, the fluid contained in the container will flow under pressure into passageway 218 via the valve means which s here provided as an umbrella type chec. valve 209. As best seen in Figure 33, valve 209, which is jf a conventional construction, is received within a cavity 165a formeα m the eno wail of receiving chamber 165 and is held in position therewithin by a cylindrically shaped housing 185a having an end wall 185b which supports cannula 185 m the manner shown in Figure 33. Valve 209 is constructed from an appropriate elastomer and has a resiliently deformable skirt portion 209a which will deform inwardly within cavity 165a to permit fluid to flow toward the reservoir of the device, but will block reverse flow. From passageway 218, the fluid will flow under pressure into reservoir 220 wnere it will cause the stored energy means or memorane 154 to distend outwardly from protuberance 158a of ullage substrate 158 in the manner shown in Figures 32 and 34.

As before, the stored energy means can be in the form of a single prestressed or unstressed isotropic, elastomeric distendable membrane, or it can comprise a laminate assemblage made up of a plurality of initially generally planar distendable elements or films. In particular, as shown in Figure 34A, the layer that will be in contact with the fluid may be a fluoroelas- tomer coating of the type made by Lauren International, Inc. that is known by the tradename FLUOROLAST WB^R. As previously discussed, as the distendable membrane 154 is distended by the fluid pressure exerted by the fluid flowing into the reservoir, internal stresses are formed therein which continuously urge the assemblage toward engagement with protuberance 158a as it tends to return toward its original configuration. As the membrane moves toward protuberance 158a, fluid within reservoir 220 will be uniformly and controllably forced outwardly through reservoir outlet 222, through passageway 224 and finally through longitudinally extending passageway 226 which is formed in ullage substrate 158. As indicated by Figures 32 and 35, upstanding tongue 164 cf base 152 extends completely about the perimeter of the base and is closely receivable within a groove 160a of capture housing 160. When the ullage substrate and the membrane capture housing are assembled in the manner shown in Figures 32 and 34, the periphery of distendable membrane 154 will be securely clamped within groove 160a by tongue 164. After the parts are thus assembled, housing 160 is bonded to base 152 by any suitable means such as adhesive or sonic bonding. This done, cover 156 is mated with capture housing 160 in the manner shown in Figures 32 and 34 and bonded in place. Referring next to Figure 35, an alternate form of the apparatus of the invention is there shown. This embodiment is virtually identical in construction and operation to that shown in Figures 32 and 34 save that the base 153 is provided with a pair of circumferentially extending tongues 153a which tongues are closely receivable within a pair of grooves 161a provided in the capture housing 161. With this construction, when the modified ullage substrate and the modified membrane capture housing are assembled in the manner shown in Figure 35, the periphery of distendable membrane 154 will be securely clamped within grooves 161a by tongues 153a. After the parts are thus assembled, housing 161 is bonded to base 153 by any suitable means such as adhesive or sonic bonding.

Once again, reference should be made to United States Serial No. 08/432,221 for the various materials that can be used to construct the base assemblies 152 and 153, the cover 156, and the membrane capture housings 160 and 161 as identified in the preceding paragraphs.

Turning now to a consideration of the important flow rate control subassembly of this latest form of the invention, this subassembly is somewhat similar to that previously described and also includes flow control means which are disposed externally of reservoir 220 for controlling the rate of fluid flow of fluid from the device. This flow control means here comprises a rate control membrane 230 (Figure 41) which is closely received within a circular recess 232 formed in support means shown here as comprising a support structure 234. Rate control membrane 230 comprises a very thin (approximately 0.018 inch thick), rigid polyester plate having a multiplicity of small laser drilled orifices 236. It is to be understood that rate control membrane 230 can be constructed from materials other than polyester, including those materials identified in Patent No. 5,205,820 which patent is incorporated herein by reference.

Referring to Figure 42B, an alternate form of the flow control means of the invention is there shown. This flow control means is usable with the various components previously described and here comprises a rate control membrane 230a of slightly different construction, which is closely received within a circular recess 232 formed in support structure 234 (see Figure 42) . Rate control membrane 230a comprises a very thin (approximately 0.018 inch thick), rigid polyester plate having only a single small laser drilled orifice 236a. This rate control membrane 230a can also be constructed from various materials including those materials identified in Patent No. 5,205,820.

Also comprising a part of the flow control means of this latest form of the invention is a vent patch or membrane 287, which is of the character previously described, and a filter membrane 237. Filter membrane 237 is positioned proximate rate control membrane 230a and functions to filter particulates from the fluids flowing from passageway 262 toward rate control membrane 230a (see also Figure 42) . Filter membrane 237 can be constructed from a number of porous materials such as metal and ceramics. A polyether sulfone material sold by Gilman Sciences under the name and style "SUPOR" has also proven satisfactory.

Turning next to Figure 42C, still another form of flow control means of the invention is there shown. This flow control means is also usable with various components previously described and here comprises frit or rate control membrane 239 which is also closely received within a circular recess form in support structure 234 (see Figure 41) . Rate control frit 239 here comprises a rigid porous glass frit of a character well known in the art which can be tailored to provide the desired flow rate. Also comprising a part of the flow control means of this latest form of the invention is a small version of the previously identified membrane 237, here identified as 237a. Also forming a part of this flow control means is the previously identified filter membrane 237. Filter membrane 237 is positioned proximate rate control frit 239 and, as before, functions to filter particulates from the fluids flowing from passageway 262 toward rate control frit 230 (see Figure 42C) .

Support structure 234 includes an outwardly extending generally cylindrically shaped, fluid inlet element 240 (Figure 42) in which is provided a fluid passageway 242. Passageway 242 is adapted to communicate with reservoir 220 via passageways 224 and 226 when support structure 234 is mated with base assembly 152. As best seen in Figure 32, base assembly 152 has a centrally disposed socket-like recess 244 that closely receives inlet element 240 when structure 234 is mated with base assembly 152.

Formed on either side of element 240 are wing-like protuberances 248 (Figure 42) which are received within spaced-apart, arcuate-shaped cavities formed in base assembly 152 (not shown) . Located proximate the upper edge of support structure 234 are arcuately, spaced-apart connector members 252 which mate with arcuately spaced openings 254 provided on cover 156 to enable secure interconnection of support structure 234 with the reservoir assembly. As shown in Figure 32, when the support structure 234 is mated with the reservoir assembly, fluid inlet passageway 242 is placed in fluid communication with reservoir 220 via passageways 224 and 226. With this construction, when fluid is forced through fluid passageway 242 of inlet 240 by the stored energy means, the fluid will flow into a vertically extending passageway 256 formed in a thin manifold plate 260 (Figure 42) which is closely receivable within a similarly shaped cavity 261 formed in the forward face of element 234 (Figure 41) . Next, the fluid will flow into a horizontally extending passageway 262 formed in manifold plate 260 and finally into a chamber 264 formed in a distendable, elastomeric first boot 266 of the flow indicator means of the invention. As shown in Figure 42A, boot 266 includes a yieldably distendable fluid flow blocking body portion 266a which is circumscribed by a marginal portion 266b. Marginal portion 266b is clamped between manifold plate 260 and a uniquely configured indicator base 268 so that the boot extends through a generally arcuate-shaped opening 268a formed in the indicator base 268. It is to be understood that, when the fluid flowing from reservoir 220 fills passageways 256 and 262 and impinges upon boot 266, flow will be diverted back in the direction of arrows 269 of Figures 41 and 42 toward support structure 234 and into a chamber 270 which is formed in the rear surface of the support structure (Figure 42). Chamber 270 is adapted to closely receive an angularly shaped insert 271 of the character shown in Figure 41. As shown in Figure 41, insert 271 includes a horizontally extending fluid passageway 272 having an inlet end 272a and an outlet end 272b. Insert 271 also has a vertically extending fluid passageway 274 having an upper inlet end 274a and a lower outlet end 274b which terminates in a socket-like cavity 276. Cavity 276 is in communication with a tubular quick-connect coupling 280 formed on support structure 234 (Figure 41) . In a manner presently to be described, tubular extension 280 is adapted to mate with a quick disconnect outlet adapter 280a which is, in turn, connected to the fluid delivery line 281 of the apparatus (Figure 30) .

It is to be observed that fluid which is diverted back from boot 266 toward support structure 234, will flow in the direction of the arrow 269 of Figure 42, through rate control element 230, and then into inlet end 272a of passageway 272 formed in insert 271. After flowing through rate control element 230, the fluid will next flow along passageway 272 toward the outlet end 272b in the direction of arrow 283 (Figure 42) and then outwardly of the passageway through an outlet port 284 formed in support structure 234. Next, the fluid will flow forwardly in the direction of arrow 285 through an orifice 288 formed in plate 260 where it will impinge on a second elastomeric, distendable boot 286 which also forms a part of the indicator means of the invention. Indicator boot 286, which is of identical construction to boot 266, is clamped within an oval shaped opening 268b formed in indicator base 268. After impinging on boot 286, the fluid will next flow back toward support structure 234 in the direction of arrow 287, through a lower orifice 290 formed in plate 260 and then, via orifice 291 formed in structure 234, into the upper inlet end 274a of passageway 274 which is formed in insert 271. Upon entering passageway 274, the fluid will flow downwardly of the passageway into cavity 276 and then into tubular extension 280 where it can enter the quick disconnect outlet adapter 280a and finally delivery line 281.

It is to be noted that fluid flowing from reservoir 220 into passageway 240 and then on toward boot 266 is under a higher pressure than fluid flowing toward boot 286. This is because the pressure of the fluid flowing toward boot 286 has been reduced as a result of the fluid flowing through rate control element 230. It should also be noted that vent means, shown here as a vent patch 289a, is provided in the system to permit air trapped within the flow control assembly to be vented via a port 289 formed in plate 260.

Next to be considered is the important flow indicator means of the invention, which functions to distinguish among three conditions of operation, namely normal fluid flow, fluid flow blockage or occlusion, and reservoir empty. Turning particularly to Figures 32, 41, and 42, the flow indicator means here comprises the previously identified indicator base or platform 268, as well as the boot clamping plate 260. Additionally, the indicator means comprises a support or lens plate 300, and a hollow housing 302 within which the platform and the support plate are enclosed (Figure 32) . As seen in Figure 32, a viewing lens 301 is viewable through an aperture 302a provided in housing 302.

Disposed between platform 268 and plate 300 are first and second indicia-carrying means shown here as a pair of closely adjacent, thin films. These films, identified here as 306 and 308, are in intimate contact and are preferably constructed from a substantially transparent, flexible polymer material such as mylar. It is to be understood that the indicia-carrying means need not be thin films, but rather can be any type of surface presenting member upon which indicia can be provided. The down- stream surface of the inferior or first film 306 is printed with three integrated symbols 307 (Figure 41) , which may comprise, by way of example, a blue circle, a green arrow, and a red X, each consisting of diagonal strips of color printed in an alternating pattern (blue, green, red, blue, green, red, and so on (see also Figures 25 through 29) . The second film 308 serves as a "mask" over film 306 and is printed with a pattern of diagonal alternating clear and opaque strips 308a that occur in approximately a 1:2 ratio. The printed ratio of the "mask" allows only one colored symbol to appear at a time when viewed through viewing lens 301. The inferior and superior films are provided at their opposite ends with apertures 310 which receive retention pins 312 provided on platform 268 (Figure 41) which permit attachment of the film to platform 268 in a manner such that the non-patterned portions of each film covers boot openings 268a and 268b provided proximate each end of platform 268 with the patterned portions cf both the superior and inferior films being maintained in index. With this construction, each thin film is able to move in response to pressure exerted thereon by the elastomeric boots in opposing directions parallel to the film plane with its range of motion limited to one axis in the film plane by edge guides 318 provided on platform 268 (Figure 41). As the films move, the visible symbol pattern will, of course, change due to the transverse displacement of the patterns imprinted thereon.

As is apparent from a study of Figure 42, the central portions of both the first and second elastomeric actuator elements or boots 266 and 286 will be deflected outwardly toward plate 300 when the device is filled and primed, but not in a state of delivery or when there is a build up of fluid pressure during delivery that is caused by blockage of the delivery line downstream from boot 286. While boot 266 can be deflected by normal line pressure, boot 286 is deflected only by pressure buildup resulting from the downstream blockage. When both elastomeric boots 266 and 286 are deflected outwardly, both the superior and inferior films are displaced transversely to a second position revealing a second symbol, as for example, an X as viewed through the viewing aperture of the support plate (see also Figures 28 and 29) .

A third alignment of symbol patterns as shown in Figures 24 and 25 is visible when the device is in an unfilled state or when the delivery line is open, the reservoir is empty and fluid delivery to the patient has been completed. In this case, there is no fluid pressure in the line on either the upstream or the downstream side of the flow control means and thus both the first and second boots are in a non-deflected position. In this condition, the inferior and superior films are not transversely displaced and thus exhibit a third combination of patterns resulting in a third symbol as, for example, a circle being visible through the viewing aperture of the support plate (See figure 25) . Boots 266 and 286 can be precisely tailored to deflect under various pressures thereby permitting great apparatus versatility. Turning next to Figures 36 through 38, still another form of the apparatus of the invention is there shown and generally designated by the numeral 330. This embodiment is similar in many respects to the embodiment shown in Figures 30 through 37 and like numerals have been used to identify like components. More particularly, only the reservoir and fill subassemblies of the device have been modified, with the flow rate control subassembly and the indicator subassembly of the device remaining unchanged.

With regard to the modified reservoir subassembly which is shown in Figure 38, this subassembly includes a base assembly 332, a distendable membrane component 154, and a cover 156 for enclosing the membrane. While the base assembly 332 includes a slightly modified ullage substrate 334, the membrane capture housing 160 is virtually identical to that previously described and includes a bottom opening 162 which receives the basically unchanged distendable membrane engaging element or protuberance 164 of base assembly 332. As before, the modified ullage substrate 334 is provided with fill assembly receiving means shown here as a longitudinally extending, generally cylindrically shaped receiving chamber 336 for receiving the fill assembly 340 which is also of a slightly different construction from that shown in Figures 30 through 37. As best seen in Figure 38, the cannula means of the latest form of the invention comprises a sharp, needle-like, hollow cannula 342, rather than a blunt end cannula. The fill assembly 340 of this latest embodiment of the invention comprises a container subassembly 344 and an adapter subassembly 346. Container subassembly 344 includes a body portion 348, having a fluid chamber 350 for containing an injectable fluid "F". Chamber 350 is provided with first and second open ends 352 and 354. First open end 352 is sealably closed by closure means here provided in the form of a pierceable septum assembly 356 which includes a septum 358. Septum 358 is pierceable by the needle-like sharp cannula mounted within receiving chamber 336. Septum 358 is held securely in position within open end 352 by clamping ring 360. As before, in order to expel fluid from chamber 350, a plunger 188 is telescopically movable within the chamber from a first location where it is proximate second open end 354 to a second position where it is proximate first open end 352.

The adapter subassembly 340 of this form of the invention comprises a hollow housing 364 having a first open end 366 and a second closed end 368. In assemblying the unit, container subassembly 344 is first inserted into the open end of chamber 336, and the adapter subassembly 340 is then introduced. As shown in Figure 38, adapter subassembly 340 also includes an elongated pusher rod 370 which functions to move plunger 188 within fluid chamber 350 from a first extended position to the second position proximate septum assembly 356 as the fill assembly is mated with the reservoir assembly. With this arrangement, when adapter assembly 340 is inserted into chamber 336, the inboard end of pusher rod 370 will operably mate with plunger 188.

As best seen in Figure 38, provided within chamber 336 is an inner cylindrically shaped wall 336a which is concentric with the inner wall 336b of receiving cnamber 336, forms an integral part of ullage substrate 334 and is radially spaced from the inner wail 336b of chamber 336 so as to define a longitudinally extending annular space 336c. With this construction, during the mating of the reservoir fill assembly with the reservoir assembly, the outer wall 364a of hollow housing 364 is closely receivable within space 336c as the adapter subassembly is urged inwardly of chamber 336. At the same time that wall 364a moves forwardly of annular space 336c, the container assembly telescopes inwardly of hollow housing 364 and is guided thereby so as to move septum 358 into piercing engagement with sharp end cannula 342. Prior to the reservoir fill assembly being mated with the reservoir assembly, chamber 336 is maintained in a sterile condition by a sterile tear-off cover assembly 374 which is bonded or otherwise removably affixed to the wall of a counter bore 376 formed in ullage substrate 334. An integral pull tab 374a is provided to permit the cover 374b to be pulled free so as to permit insertion of the reservoir fill assembly into chamber 336. Cover assembly also includes an inwardly extending tab 374c which engages teeth-like protuberances 375 formed on wall 364a of the fill adapter so as to prevent removal thereof after the fill assembly has been mated with the reservoir assembly.

As plunger 188 of the container assembly is moved forwardly of container 344 by pusher rod 370, the fluid contained in the container will flow under pressure into a passageway 380 via hollow cannula 342 and via an umbrella type check valve 382 which is of similar construction and operation to valve 209. Valve 382 is received within a cavity 332a formed in the end wall of receiving chamber 336 and is held in position therewithin by a disc-shaped member 384 which supports cannula 342 in the manner shown in Figure 38. Valve 382 is constructed from an appropriate elastomer and has a resiliently deformable skirt portion 382a which will deform inwardly within cavity 332a to permit fluid to flow toward the reservoir of the device but will block reverse flow. From passageway 380, the fluid will flow under pressure into reservoir 390 where it will cause the stored energy means or membrane 154 to distend outwardly from ullage substrate 334 in the manner shown in Figure 38.

After the reservoir has been filled and as membrane 154 moves toward substrate 334 during the fluid dispensing step, fluid within reservoir 390 will be uniformly and controllably forced outwardly through reservoir outlet 392, through a passageway 394 and then into passageway 242 of the fluid inlet to substrate 234 of the flow control means (see for example Figure 32) .

As shown in Figure 38, the embodiment of this latest form of the invention also includes a uniquely designed auxiliary filling means mounted on ullage substrate 334 which enables filling of reservoir 390 other than by mating the fill assembly 340 with the reservoir assembly. This auxiliary filling means here comprises a generally cylindrically shaped housing 402 having a fluid inlet 402a and a fluid outlet 402b in communication with reservoir 390. Housing 402 terminates at its inlet end in a conventional luer type connector end 404 and includes valve means for controlling fluid flow between inlet 402a and outlet 402b. Valve means 400 here comprises a valve seat 406 which is adapted to sealably engage a tapered shoulder 408 formed on a generally cylindrically shaped valve member 410. Valve member 410 is mounted within housing 402 for reciprocal movement therewithin between a valve closed position shown in Figure 38 and a valve open position wherein tapered surface 408 is moved away from valve seat 406 a distance sufficient to permit fluid flow toward reservoir 390. An apertured cover 412 closes the upper open end of housing 402 with the aperture 414 which is provided therein in alignment with a reservoir inlet passageway 416.

In using the auxiliary fill means of the invention, a sanitary closure cap 417, which is temporarily received over luer connector end 404 is first removed. This done, a conventional luer-type connector can be interconnected with end 404 of housing 402 so as to open communication between the interior of housing 402 and a conventional fill line interconnected with the luer connector (not shown) . The luer connector and fill line is of standard construction and, in this instance, includes an outwardly extending pintle which engages valve member 410 as the luer connector is mated with housing 402 so as to move valve member 410 intc its second open position permitting fluid to flow from the fluid delivery line past valve member 410 and into reservoir 390 via inlet 416. Such a luer connector construction is well understood by those skilled in the art. It is to be observed that the auxiliary fill means can be used as the primary fill means for filling the reservoir or, alternatively, can be used to add an appropriate additive fluid to fluid earlier dispensed into the reservoir 390 by the vial-type fill assembly 340.

Referring next to Figures 36 and 37, still another form of fill means of the invention is there shown. This alternate fill means comprises a pistol grip-type fill device 420 which is usable with a reservoir assembly of the character shown in Figure 37 which is similar in construction to the reservoir assembly shcv.n in Figure 38. As best seen in Figure 36, fill device 420 includes a hollow barrel portion 422 and an interconnected hand grip portion 424. Provided at the forward end of barrel portion 422 is a septum assembly 426 which includes a pierceable septum of the same general character as pierceable septum 358 shown in Figure 38. Provided at the opposite end of barrel 420 from septum assembly 426 is a connector means 428 for interconnecting the interior of barrel portion 422 with a fill line 430 which is, in turn, connected to a pressurized source of medicinal fluid of the character to be used in the filling of reservoir 390.

The fill means of this latest form of the invention is useα in connection witn the modified reservoir assemoly shown in Figure 38 by holding the reservoir in one hand m the manner shown in Figure 37. With the pistol grip fill means held in the other hanα as shown in Figure 37, barrel 422 is inserted nto chamber 336 and pushed forwardly of the base assembly to cause cannula 342 to pierce septum assembly 426 thereby opening communication between supply line 430 and reservoir 390 of the reservoir subassembly. It is to be understood that the reservoir assembly usable with the pistol grip filling means shown in Figure 36 can also be of the character shown in Figure 32 which is provided with a blunt end cannula 135 rather a needle-lικe cannula 342 as shown in Figure 37. In this instance, the septum assembly 426 will, of course, embody a split septum rather than a needle-piercmg septum so as to accommodate tne blunt-end cannula.

Turning next to Figures 39 and 40, still another embodiment of the invention is there shown and generally designated by the numeral 440. This embodiment is also similar m many respects to the embodiment shown in Figures 30 througn 37 and like numoers have been usea to identify Iι e components. More particularly, only the t ll assembly 444 and the nousmg 442, which supports the blunt end cannula 185, nave oeen modified with the remainder of the device remaining unchanged. The main purpose of this latest embodiment of the invention is to provide means for coupling a container assembly having a standard needle piercing septum with a reservoir assembly having a olunt end cannula.

As shown in Figure 39, modified housing 442 of the reservoir assembly of this latest form of the invention supports the blunt end cannula 185 in the manner previously described. However, the inner wall 442b of the skirt portion 442a thereof is provided with a circumferentially extending bead or protuberance 442c which, in a manner presently to be described, lockably engages a portion of the modified fill assembly 444.

The modified fill assembly 444 of the form of the invention shown in Figures 39 and 40 comprises a hollow housing 448 having a first open end 450 and a closed second end 452. The container subassembly, which is of identical construction to the container subassembly 340 shown in Figure 38, is telescopically receivable within the open end 453a of a second housing 453 which is, in turn, receivable within housing 448 in the manner shown in Figure 39. Second housing 453 is of a novel generally cylindrically shaped construction of a character presently to be described. As shown in Figure 39, assembly 444 includes an elongated pusher rod 454 which, as the fill assembly is mated with the reservoir assembly, functions to move plunger 188 of the container subassembly telescopically of fluid chamber 350 from a first extended position to the second position proximate septum assembly 356.

As best seen by referring to Figure 40, second housing 453 includes a hollow, central body portion 460 and a forward end portion 462 having an open end 462a and a circumferentially extending bead or protuberance 462b surrounding open end 462a. Sealably closing open end 462 is a split septum 464 which is of a conventional construction adapted to sealably receive a blunt end cannula such as cannula 185 which is carried by modified housing 442.

Extending through and supported by a wall 466 which divides body portion 460 and forward portion 462 of second housing 453 is a sharp needle-like hollow cannula 470 which is adapted to sealably pierce septum 358 of container assembly 340. In using the apparatus of this latest embodiment of the invention, container assembly 340 is first inserted into open end 453a of second housing 453 and is urged forwardly to the position shown in Figure 40 wherein needle-like cannula 470 pierces septum 358. This step opens communication between fluid chamber 350 of the container assembly and a subchamber 471 formed in the forward portion 462 of second housing 453 and in communication with chamber 473 which sealably receives split septum 464. After removing a protective cap 472 which closes open end 462a of forward portion 462, the assembly made up o second housing 453 and fluid container assembly 340 is mated with hollow housing 448. The assemblage is then urged forwardly of chamber 165 which causes pusher rod 454 to move plunger 188 of the container assembly forwardly of chamber 350. As the assemblage seats the split septum 464 will be sealably pierced by blunt end cannula 185. This step opens fluid communication between chamber 350 of the container subassembly and chamber 332a which nouses check valve 382. As before, as the fluid contained within chamber 350 of the container subassembly is urged outwardly of the container by forward movement of plunger 188, the fluid contained within the container assembly will flow through hollow needle 470, through hollow blunt end cannula 185, past umbrella check valve 382 and into reservoir 220 via inlet portion 218. As shown in Figure 39, when the fill assembly seats within receiving chamber 165, protuberance 462b formed on second housing 453 will move past protuberance 442c formed in skirt 442a of the cannula support housing thereby locking second housing 453 against removal from the reservoir assembly. Similarly, tab 374c formed on closure cap assembly 374 will lockably engage the saw tooth shaped protuberances 475 formed on housing 448 so as to prevent removal of housing 448 from the reservoir assembly.

It is apparent that with this latest embodiment of the invention, a container subassembly of the character shown in Figure 38 which has a standard septum 358 can be readily mated with an apparatus of the character shown in Figure 39 which embodies a blunt end cannula 185, without having to modify either the container subassembly or the reservoir assembly.

Turning to Figures 43, 44, and 45, yet another embodiment of the invention is there illustrated. This embodiment is generally similar tc the embodiment shown in Figure 38 save that the reservoir assembly does not include the secondary fill means and save for the fact that the cannula means is of a slightly different construction. Also different from the embodiment of the invention shown in Figure 38 is the fill means of the invention which is here designed to accommodate a fluid container subassembly which has a diameter substantially less than the internal diameter of' wail 336a of the base assembly. Because of the similarity of construction, like numerals are used to identify like components.

As best seen in Figure 44, to accommodate a smaller diameter container assembly of the character there shown, a plurality of ring-like guide members 480 are positioned at longitudinally spaced apart locations along inner wall 336a. Each of these ring-shaped guide members 480 includes a plurality of circumferentially spaced, resiliently deformable tabs 480a which extend inwardly relative from wall 336a and function to guidably engage the outer wall of body portion 482 of the fluid container assembly 484 of this latest form of the invention (Figure 44) . Container assembly 484 includes a septum assembly 356 of the same general construction as shown in Figure 38, the pierceable septum 358 of which is adapted to be pierced by the sharp end, needle-like cannula 342 which is supported by a slightly differently configured cannula support 493. As before, a plunger 486 of the container assembly is moved longitudinally of fluid chamber 488 by a pusher rod 490 which forms a part of the hollow housing 492 of the adapter portion of the fill means. As before, as housing 492 of the fill means is inserted into annular space 336c in the manner shown in Figure 44, pusher rod 490 will move plunger 486 forwardly of the fluid container assembly causing fluid flow through cannula 342, past check valve 382, and into fluid reservoir 390 via an inlet 494. As adapter sleeve 492 is mated with the reservoir assembly, the fluid container assembly will remain perfectly centered with respect to pusher rod 490 due to the guiding action of tabs 480a of guide rings 480.

Turning next to Figures 46 through 54A, yet another form of the apparatus of the invention is there shown and generally identified by a numeral 500. This form of the apparatus is similar tc that illustrated in Figures 30 through 34 and like numbers are used to identify like components. However, in this latest embodiment only three major cooperating subassemblies are provided, namely, a reservoir subassembly 500a, a flow rate control subassembly 500b (Figure 53), and a fill assembly 500c (Figure 47) . An important feature of this latest embodiment is the provision of a highly novel closure means for closing the forward end of the device. This closure means, which is best seen in Figures 47 and 48 and is generally designated therein by the numeral 517. This important closure means will be further described in the paragraphs which follow.

As indicated in Figure 48, the reservoir subassembly 500a of this latest embodiment is quite similar to that shown in Figure 32 and includes a base assembly 502, a stored energy source, shown here as a distendable membrane component 504, and a cover 506 for enclosing the stored energy source in the manner previously discussed. The base assembly, only a portion of which is shown in Figure 48, is of the same basic design as base assembly 152 and includes an ullage substrate 508 as well as a membrane capture housing 510 which is of identical construction to previously described capture housing 160. Housing 510 includes a bottom opening 512 which receives the distendable membrane engaging element or protuberance 514 (see also Figure 34) of base assembly 502.

As before, ullage substrate 508 is provided with fill assembly receiving means which takes the form of a longitudinally extending, generally cylindrically shaped receiving chamber which is similar in construction to previously described chamber 165 (Figure 32), and which function to receive a fill assembly 500c which assembly is identical to fill assembly 150d. Valve and cannula means of identical construction and operation to that previously described are disposed within the fill assembly receiving chamber and cooperate with the fill assembly to fill reservoir 515.

As in the earlier discussed embodiments, the stored energy means can take the form of a single prestressed or unstressed isotropic, elastomeric distendable membrane, or it can comprise a laminate assemblage made up of a plurality of initially generally planar distendable elements or films. As the dis- tendable membrane 154 is distended by the fluid pressure exerted by the fluid flowing into reservoir 515, internal stresses are formed therein which continuously urge the assemblage toward engagement with protuberance 508a (Figure 48) as it tends to return toward its original configuration. As the membrane moves toward protuberance 508a, fluid within reservoir 515 will be uniformly and controllably forced outwardly through reservoir outlet 518, through passageway 520 and finally through a longitudinally extending passageway 522 which is formed in ullage substrate 508 (Figure 48).

As previously discussed, the upstanding tongue of base 502 extends completely about the perimeter of the base and is closely receivable within a groove 510a provided in capture housing 510. When the ullage substrate and the membrane capture housing are assembled in the manner shown in Figures 48, 32 and 34, the periphery of distendable membrane 504 will be securely clamped within groove 510a by tongue 514. After the parts are thus assembled, cover 506 is mated with the capture housing 510 in the same manner as is shown in Figures 32 and 34 and then is suitably bonded in place.

Turning now to a consideration of the important cover means of this latest form of the invention, this means here comprises a housing assembly 528 which is interconnected with the reservoir subassembly 500a and functions to close the forward or delivery end of the device (see Figures 47 and 48) . As best seen in Figure 48, housing assembly 528 includes a first or forward compartment 528a and a second, or rearward compartment 528b. Rearward compartment 528b houses a support structure 530, which is generally similar in construction to support structure 234 (Figure 32) . Like support structure 234, support structure 530 includes an outwardly extending, generally cylindrically shaped, fluid inlet element 532 within which is provided a fluid passageway 534. When support structure 530 is mated with base assembly 502, passageway 534 will communicate with reservoir 515 via passageways 520 and 522. As before, base assembly 502 has a centrally disposed, socket-like recess 535 that closely receives inlet element 532 when structure 530 is mated with base assembly 502 in the manner shown in the drawings.

The flow control means of this latest form of the invention for controlling the rate of fluid flow of fluid from the device here ' comprises a novel flow control assembly 540 of the character shown in Figures 52 and 53. As best seen in Figures 50 and 51, a rate control assembly 540 is mounted within a socket like portion 542 formed in an insert 544 which is received within a cavity 546 formed in the forward wall 530a of support structure 530 (see Figure 54). Insert 544, in cooperation with a fluid passageway 548 formed in support structure 530, functions to provide a fluid flow path between reservoir 515 and the flow control assembly 540. More particularly, assembly 540 here comprises a quick disconnect housing 550 which has a central fluid passageway 552 having an inlet 554 which communicates with passageway 548 in the manner shown in Figures 50 and 51.

Interconnected with quick disconnect housing 550 is a delivery line housing 556 to which a delivery line 558 is sealably connected. Disposed within housing 556 is an elastomeric compression ring 560 which sealably receives the flow rate control means of this form of the invention, which means is here provided as a generally cylindrically shaped rate control frit 562. Also forming a part of the flow control means of this latest embodiment is filter means, here shown as a filter element 564 which is disposed between frit 562 and quick disconnect housing 550 (Figure 53) . Frit 562 and filter element 564 are preferably constructed from the same type of materials as previously identified herein in connection with the discussion of elements 237 and 239.

When insert 544 is in position within cavity 546 in the manner shown in Figure 50, quick connect socket portion 542 extends into forward chamber 528a of the closure means. With this construction, the flow control means can be placed in fluid communication with the fluid reservoir of the device by inserting quick disconnect housing 550 into socket portion 542 and then turning it in conventional fashion to securely lock it in position. To prevent leakage of fluid between housing 550 and socket portion 542 an elastomeric O-ring 565 is provided in housing 550 (Figures 52 and 53) .

Connected to the flow control means is the fluid delivery means of the invention. This latter means, which is uniquely removably stowed within first or forward compartment 528a of the closure means, here comprises a delivery line luer assembly 570 and a line clamp 572 both of which are of conventional construction. Previously identified delivery line 558 is interconnected with luer assembly 570 in the manner shown in Figure 47. Disposed between the flow control means and luer assembly 570 is a vent means shown here as a conventional gas vent assembly 574 for venting gases trapped within the system to atmosphere.

Forward compartment 528a is formed within an access door 576 which is connected to that portion of the rearward portion of housing 528 which defines rearward compartment 528b, by hinge means here shown as a pair of living hinge elements 577. With this arrangement, door 576 can be pivoted relative to the reservoir assembly from the closed position shown in Figure 48 to the open position shown in Figure 47. Door 576, which forms a part of closure means 517, includes a front face 576a which, in cooperation with an interconnected circumscribing wall 576b, forms forward compartment 528a (Figures 47 and 49) . Latching means, shown here as comprising an arcuate protuberance 579 formed on housing 528, and an arcuate locking tab 581 formed on door 576, cooperate to latchably maintain the door in a normally closed condition (Figure 48) . With this novel arrangement, the delivery means of the invention can remain securely stowed within compartment 528a until time of use.

Turning next to Figures 55 through 60, still another form of the apparatus of the invention is there shown and generally identified by a numeral 600. This form of the apparatus is somewhat similar to that illustrated in Figures 46 through 54 and like numbers are used to identify like components. In this latest embodiment three major cooperating subassemblies are

As indicated in Figure 58, the reservoir subassembly 600a of this latest embodiment is virtually identical to reservoir subassembly 5C0a and, therefore, will not be described in further detail. Suffice to say that the reservoir subassembly includes a stored energy source, shown as a distendable membrane component 504 and a cover 506 for enclosing the stored energy source in the manner previously discussed. The base assembly, only a portion of which is shown in Figure 58, is of the same basic design as base assembly 522 and includes an ullage substrate 608 as well as a membrane capture housing 510 which is of identical construction to previously described capture housing 160. Since in this embodiment, the reservoir is filled by an external fill line, or the like, no container type fill means is provided and, accordingly, the ullage substrate has no fill assembly receiving chamber. Reference should be made to Figure 3B wherein the details of construction of the fill means 50 of this latest form of the invention is shown.

With regard to the cover means of this latest form of the invention shown in Figures 55 and 56, this means here comprises a housing assembly 628 which is interconnected with the reservoir subassembly 600a and functions to close the forward or delivery end of the device (see Figures 58 and 59) . As best seen in Figure 58, housing assembly 628 includes a first or forward compartment 628a and a second, or rearward compartment 628b. Rearward compartment 628b houses a support structure 530, which is generally similar in construction to support structure 234 (Figure 32). Like support structure 234, support structure 530 includes an outwardly extending, generally cylindrically shaped, fluid inlet element 532 within which is provided a fluid passageway 534. When support structure 530 is mated with base assembly 502, passageway 534 will communicate with reservoir 515 via passageways 520 and 522. As before, base assembly 502 has a centrally disposed, socket-like recess 535 that closely receives inlet element 532 when structure 530 is mated with base assembly 502 in the manner shown in the drawings.

The flow control means of this latest form of the invention for controlling the rate of flow of fluid from the device is substantially identical to that previously described and comprises a rate control frit 562 and a filter element 564 (Figure 59) . These elements function in the manner described in connection with Figures 46 through 54 and are assembled together in the manner shown in Figures 52 and 53.

Interconnected to a quick disconnect housing 550 of the character previously described is a delivery line housing 556 to which a delivery line 558 is sealably connected (Figure 59) . As before, when the various components of the flow control assembly 540 are interconnected in the manner shown in Figure 53 and when the assembly is in position within socket portion 542, the flow control means is in fluid communication with the fluid reservoir 515 of the device.

In addition to delivery line 558, the fluid delivery means of this latest form of the invention also comprises a delivery line luer assembly 570 and a line clamp 572 both of which are of the character previously described. Disposed between the flow control means and luer assembly 570 is a vent means shown here as a conventional gas vent and filter assembly 574, which is alsc of the character previously described.

As best seen in Figures Ξ6, 58, and 59 the front face 628c of forward compartment 628a is formed with a plurality of cavity- like recesses which receive portions of the delivery means. More particularly, face 628c has formed therein a cavity 570a which closely receives luer assembly 570, a cavity 572a which closely receives clamp 572 and a cavity 574a which closely receives gas vent assembly 574. Turning to Figure 59, it is to be noted that delivery line 558 extends downwardly of forward compartment 628a and passes through an opening 575. The line can then be uniquely wound around housing 628 so that it safely resides within a circumferentially extending channel 577 provided in the housing (Figures 58, 59, and 60) . With this novel^' arrangement, until the device is to be used, the luer assembly 570, the roller clamp 572, and the vent assembly 574 can be conveniently stowed with the cavities formed in face 628c with the delivery line neatly wrapped around the unit and tightly stowed within channel 577. At time of use, the components can be quickly and easily removed from their respective storage cavities and the delivery line expeditiously unwound from the unit. Upon releasing the line clamp 572, and removal of the luer aseptic cup 570b (Figure 55), the stored energy means will then cause fluid to flow through the delivery line at a precisely controlled rate.

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.

Claims

CLAIMS :

1. A device for use in infusing medicinal fluid into a patient at a controlled rate comprising:

(a) a base having a receiving chamber formed therein;

(b) a hollow cannula mounted within said receiving chamber of said base;

(c) stored energy means for forming, in conjunction with said base a fluid reservoir having an inlet in communication with said hollow cannula and an outlet, said energy storage means comprising at least one distendable member superimposed over said base, said member being distendable as a result of pressure imparted by the fluids to be infused, to establish internal stresses, said stresses tending to move said member toward a less distended configuration;

(d) fill means receivable within said receiving chamber of said base for filling said fluid reservoir;

(e) an outlet port in communication with said outlet of saic: fluid reservoir for dispensing fluids from the device; and

(f) fluid actuated indicator means disposed intermediate said fluid outlet of said reservoir and said outlet port for visually indicating fluid flow from said fluid reservoir.

2. A device as defined in Claim 1 further including flow control means disposed intermediate said indicator means and said outlet of said fluid reservoir for controlling the rate of flow of fluid from the device.

3. A device as defined in Claim 1 in which said indicator means comprises first and second at least partially overlaying thin films, said films being movable relative to each other in response to fluid flowing from said fluid reservoir.

4. A device as defined in Claim 1 in which said fill means comprises a container subassembly, said container subassembly comprising:

(a) a container having a fluid chamber with first and second open ends;

(b) pierceable means for sealably closing one of said first and second open ends of said container, said pierceable means being pierceable by said hollow cannula; and

(c) ^' a plunger telescopically movable within said container from a first location proximate said pierceable means to a second, spaced-apart location.

5. A device as defined in Claim 4 in which said fill means further comprises an adapter subassembly, said adapter subassembly including a hollow housing for receiving said container, said hollow housing having first and second ends.

6. A device as defined in Claim 5 in which said adapter subassembly includes pusher means for moving said plunger of said container assembly from said first location toward said second location.

7. A device for use in infusing medical fluids comprising:

(a) a base assembly including:

(i) an ullage substrate having a receiving chamber formed therein; and

(ii) a hollow cannula mounted within said receiving chamber;

(b) stored energy means for forming in conjunction with said base assembly a fluid reservoir having an inlet in communication with said hollow cannula and an outlet, said energy storage means comprising at least one distendable member superimposed over said base, said member being distendable as a result of pressure imparted by the fluids to be infused, to establish internal stresses, said stresses tending to move said member toward a less distended configuration;

(c) fill means receivable within said receiving chamber of said base for filling said fluid reservoir, said fill means comprising a fill assembly including a container subassembly and an adapter subassembly, said container subassembly comprising:

(i) a container having a fluid chamber with first and second open ends;

(ii) pierceable means for sealably closing one of said first and second open ends of said container, said pierceable means being pierceable by said hollow cannula; and (iii)a plunger telescopically movable within said container from a first location proximate said pierceable means to a second, spaced-apart location;

(d) an outlet port in communication with said outlet of said reservoir for dispensing fluids from the device;

(e) fluid actuated indicator means disposed interme- diatesaid fluid outlet of said reservoir and said outlet port for visually indicating fluid flow from said fluid reservoir; and

(f) flow control means disposed intermediate said indicator means and said outlet of said fluid reservoir for controlling the rate of flow of fluid from the device.

8. A device as defined in Claim 7 in which said indicator means comprises first and second at least partially overlaying thin films, said film being movable relative to each other in response to fluid flowing from said fluid reservoir.

9. A device as defined in Claim 8 in which said indicator means includes actuator means movable by fluid flowing from said reservoir between a first position wherein said actuator means are spaced from said thin films to a second position wherein said actuator means engage at least one of said thin films.

10. A device as defined in Claim 9 in which said actuator means comprise first and second actuator elements disposed proximate said first and second thin films, said first actuator element being movable into engagement with said first film and said second actuator element being movable into engagement with said second film.

11. A device for use in infusing medical fluids comprising:

(a) a base assembly including:

(i) an ullage substrate having a receiving chamber formed therein; and

(ii) a hollow cannula mounted within said receiving chamber;

(c) fill means for filling said fluid reservoir, said fill means comprising a fill assembly including a container subassembly and an adapter subassembly, said container subassembly comprising:

(i) a fill assembly including a fluid container and an adapter subassembly, for interconnecting said fluid container with said base assembly; and

(ii) an auxiliary filling means including a housing connected to said ullage substrate, said housing having a fluid inlet in communication with said fluid reservoir, a fluid outlet spaced apart

60/1 fluid flow between said fluid inlet and said fluid outlet;

(d) an outlet port in communication with said outlet of said reservoir for dispensing fluids from the device; and

(e) fluid actuated indicator means disposed intermediate said fluid outlet of said reservoir and said outlet port for visually indicating fluid flow from said fluid reservoir.

(a) pierceable means for sealably closing one of said first and second open ends of said container, said pierceable means being pierceable by said hollow cannula; and

(b) a plunger telescopically movable within said container from a first location proximate said pierceable means to a second, spaced-apart location.

13. A device as defined in Claim 11 in which said indicator means comprises first and second at least partially overlaying thin films, said film being movable relative to each other in response to fluid flowing from said fluid reservoir.

14. A device as defined in Claim 11 further including flow control means disposed intermediate said indicator means and said outlet of said fluid reservoir for controlling the rate of flow of fluid from the device.

61

15. A device for use in infusing medicinal fluid into a patient at a controlled rate comprising:

(a) a base having a receiving chamber formed therein;

(b) a hollow blunt end cannula mounted within said receiving chamber of said base;

(d) container means interconnectable with said base for filling said fluid reservoir said container means comprising:

(i) a container having a fluid chamber with first and second open ends;

(ii) a plunger telescopically movable within said container from a first location proximate said pierceable means to a second, spaced-apart location;

(d) adapter means for interconnecting said container means with said base, said adapter means comprising:

(i) first hollow housing for receiving said container of said container means, said first hollow housing having:

a. first and second open ends; b. an intermediate wall disposed between said first

62 and second open ends; c. a sharp, needle-like hollow cannula connected to and extending through said intermediate wall for piercing engagement with said pierceable means of said container assembly; and d. a split cannula sealably closing said first end of said first hollow housing;

(ii) a second hollow housing for receiving said first hollow housing, said second hollow housing being receivable within said receiving chamber of said base to move said split cannula of said first hollow housing into engagement with said blunt end cannula; and

(e) fluid dispensing means in communication with said outlet of said fluid reservoir for dispensing fluids from the device.

16. A device as defined in Claim 15 further including fluid actuator means disposed intermediate said fluid outlet of said reservoir and said fluid dispensing means for, visually indicating fluid flow from said fluid reservoir.

17. A device as defined in Claim 16 further including flow control means disposed intermediate said indicator means and said outlet of said fluid reservoir for controlling the rate of flow of fluid from the device.

18. A device as defined in Claim 17 in which said indicator means comprises first and second at least partially overlaying thin films, said films being movable relative to each other in response to fluid flowing from said fluid reservoir.

19. A device for use in infusing medical fluids com-

63 prising :

(a) a base assembly including:

(i) an ullage substrate having a receiving chamber formed therein; and

(ii) a hollow cannula mounted within said receiving chamber;

(iii)a plurality of generally ring shaped guides mounted within said receiving chamber;

(b) stored energy means for forming in conjunction with said base assembly a fluid reservoir having an inlet in communication with said hollow cannula and an outlet, said energy storage means comprising at least one distendable member superimposed over said base, said member being distendable as a result of pressure imparted by the fluids to be infused, to establish internal stresses, said stresses fencing to move said member toward a less distended configuration; and

(c) fill means receivable within said receiving chamber of said base for filling said fluid reservoir, said fill means comprising a fill assembly including a container and an adapter subassembly, said container being telescopically movable within said receiving chamber from a first position to a second position, said container also receivable within and guided by said ring shaped guides as said container moves from said first location to said second location.

20. A device as defined in Claim 19 in which said adapter subassembly comprises a hollow housing having an elongated generally cylindrical wall.

64

21. A device as defined in Claim 20 in which said ullage substrate is provided with an elongated bore having a longitudinally extending surface and in which said receiving chamber of said ullage substrate is defined by an elongated, generally cylindrically shaped inner wall , said inner wall defining .in conj unction with said surface of said bore, an annular space , said wall of said hollow housing of said adapter subassembly being telescopically receivable within said annular space .

22. A device as defined in Claim 21 further including fluid actuated indicator means for visually indicating fluid flow from said fluid outlet of said reservoir .

23. A device as defined in Claim 22 further including flow control means disposed intermediate said indicator means and said outlet of said fluid reservoir for controlling the rate of flow of fluid from the device .

24 . A device as defined in Claim 23 in which said indicator means comprises first and second at least partially overlaying thin films , said films being movable relative to each other in response to fluid flowing from said fluid reservoir .

25. A device for use in infusing medicinal fluid into a patient at a controlled rate comprising :

(a) a base having a receiving chamber formed therein;

(b) a hollow cannula mounted within said receiving chamber at said base;

(c) stored energy means for forming, in conjunction with said base a fluid reservoir having an inlet in communication with said hollow cannula and an outlet, said energy storage means comprising a laminate assemblage including at least one initially generally

65 planar distendable member superimposed over said base and at least one coating layer affixed to said distendable member, said laminate assembly being distendable as a result of pressure imparted by the fluids to be infused, to establish internal stresses, said stresses tending to move said laminate assemblage toward a less distended configuration;

(e) an outlet port in communication with said outlet of said fluid reservoir for dispensing fluids from the device;

(f) fluid actuated indicator means disposed intermediate said fluid outlet of said reservoir and said outlet port for visually indicating fluid flow from said fluid reservoir; and

(g) flow control means disposed intermediate said indicator means and said outlet of said fluid reservoir, said flow control means comprising rate control means for controlling the rate of flow of fluid from the device and filter means for filtering particulates from fluid flowing toward said rate control means.

26. A device as defined in Claim 25 in which said distendable member of said stored energy means comprises an elastomer and in which said coating layer comprises a fluoroelas- tomer.

27. A device as defined in Claim 25 in which said rate control means comprises a rigid polyester plate having at least one orifice therethrough.

66

28. A device as defined in Claim 25 in which said rate control means comprises a rigid polyester plate having a multiplicity of laser drilled orifices formed therein.

29. A device as defined in Claim 25 in which said rate control means comprises a porous glass frit.

30. A device as defined in Claim 25 in which said filter means comprises 'a porous filter membrane disposed proximate said rate control means.

31. A device as defined in Claim 30 in which said porous filter membrane is constructed from a polyester sulfone material.

32. A device as defined in Claim 30 in which said indicator means comprises first and second at least partially overlaying thin films, said films being movable relative to each other in response to fluid flowing from said fluid reservoir.

33. A device as defined in Claim 30 in which said fill means comprises a container subassembly, said container subassembly comprising:

(a) a container having a fluid chamber with first and second open ends;

(c) a plunger telescopically movable within said container from a first location proximate said pierceable means to a second, spaced-apart location.

34. A device as defined in Claim 33 in which said fill means further comprises an adapter subassembly, said adapter

67 subassembly including a hollow housing for receiving said container, said hollow housing having first and second ends.

35. A device as defined in Claim 33 in which said filter means includes indicator means for determining the amount of fluid remaining in said container.

36. A device for use in infusing medicinal fluid into a patient at a controlled rate comprising:

(a) a reservoir assembly including a base;

(b) stored energy means for forming, in conjunction with said base a fluid reservoir having an inlet and an cutlet, said stored energy neans comprising at least one distendable member superimposed over said base, said member being distendable as a result of pressure imparted by the fluids to be infused, to establish internal stresses, said stresses tending to move said member toward a less distended configuration;

(c) fluid delivery means in communication with said cutlet of said fluid reservoir for delivery fluid from the device;

(d) flow control means disposed intermediate said cutlet of said fluid reservoir and said fluid delivery means for controlling the rate of flow of fluid flowing from said fluid delivery means; and

(e) closure means connected to said reservoir assembly for supporting therewithin said fluid delivery means.

37. A device as defined in Claim 36 in which said closure means comprises a door pivotally movable relative to said reservoir assembly.

38. A device as defined in Claim 36 in which said closure

68 means comprises a closure housing having a front face provided with a plurality of component storage cavities.

39. A device as defined in Claim 36 in which said flow control means comprises rate control means for controlling the rate of flow of fluid from said fluid delivery means and filter means for filtering fluid flowing from said reservoir toward said rate control means.

40. A device as defined in Claim 36 in which said base of said reservoir assembly has a receiving chamber formed therein and in which said device further includes fill means receivable within said receiving chamber for filling said fluid reservoir.

41. A device as defined in Claim 40 in which said fill means comprises a container subassembly, said container subassembly comprising:

(a) a container having a fluid chamber with first and second open ends;

(b) pierceable means for sealably closing one of said first and second open ends of said container; and

42. A device as defined in Claim 41 in which said fill means further comprises an adapter subassembly, said adapter subassembly including a hollow housing for receiving said container, said hollow housing having first and second ends.

69 AMENDED CLAIMS

[received by the International Bureau on 22 May 1998 (22.05.98); original claim 12 amended; remaining claims unchanged (1 page)]

(ii) an auxiliary filling means including a housing connected to said ullage substrate, said housing having a fluid inlet in communication with said fluid reservoir, a fluid outlet spaced apart from said fluid inlet and valve means for controlling fluid flow between said fluid inlet and said fluid outlet;

12. A device as defined in Claim 11 in which said fluid container of said fill assembly has first and second open ends and in which said fill assembly further includes:

14. A device as defined in Claim 11 further including flow control means disposed intermediate said indicator means and said outlet of said fluid reservoir for controlling the rate of flow of

70