CA2224124A1

CA2224124A1 - Medicament dispenser

Info

Publication number: CA2224124A1
Application number: CA002224124A
Authority: CA
Inventors: Marshall S. Kriesel
Original assignee: Individual
Current assignee: Science Inc
Priority date: 1995-06-06
Filing date: 1996-06-06
Publication date: 1996-12-12
Also published as: EP0836505A1; US5743879A; WO1996039220A1; EP0836505A4; US6063059A; JPH11507260A; AU6160796A; US5876377A

Abstract

An injectable medicament dispenser (12) for use in controllably dispensing fluid medicaments, such as an insulin, antibiotics, oncolytic, and the like from a pre-filled container (14) at a uniform rate. The dispenser includes a unique stored energy means (48a-48c).

Description

MEDICAMENT DISPENSER
~PECIFI~TION
Back~round of the Invention Field of the Invention The present invention relates generally to fluid mPtlir~mPnt ~ e~rl~ More particularly, the mvention concerns a ~ P~l~e~ for use in controllably disl~el~illg a liquid mP-lir~mPnt as, for example, an insulin solution.
Discussion of the Invention Traditionally, conventional syringes are used to inject many beneficial agent solutions such as insulin. In accordance with conventional procedures, the ~l~sclibed dose is first drawn into the syringe and a visual check is made to make certain that the correct amount of insulin is present in the syringe. Next, air is expelled from the syringe and the dose is injected m~ml~lly.
These cc"lvt:lllional procedures have llulll~lulls drawbacks including adverse reaction caused by the bolus injection of drugs by hand via a syringe. In the majority of cases, the adverse reactions are not due to the drug itself, but rather are due to an illl~ )C~
rate of injection of the drug. Ideally, the collLe~ of a syringe should be delivered over a number of minlltPs or hours. However, in clinical practice, this rarely occurs due to time Ul~ on the staff who must operate the syringe m~ml~lly Rec~llce diabetics generally require regular and l~cal~d injectior~ of insulin, the use of self-delivering devices, such as conventional syringes, is cumbersome, time Co~ g, and da~ .,us if not pluy~.ly ~,rulllled. In addition, the process of stir1~ing one's self and expulsing the liquid ",~.l;r,..~ 1 can be extremely unpleasant for the mPt~ir~lly Ulllldillcd. For this reason, several types of .li~ "!~i"g devices have been sn~gPsted for ~ r~ y di~ellsillg a pred~ ~ "..i--Pd quantity of a liquid mP~1ir~mPnt such as insulin from a multi-does container.
Exemplary of such devices are those described in European Patent Application No. 37696 and in U.S. Patent No. 4,592,745 issued to Rex, et al. Both of the aforementioned devices CA 02224124 1997-12-0~

W O 96/39220 PCT~US96/09516 dispellse a pre~ Pd quantity of liquid from a liquid I~S~ uil or container and both include m~-~h~llir~l opeldLing IllPc~ ---c for expelling the fluid from the reservoir.
The Rex, et al device co~ lises an elongated body formed from two separable sections one of which collLdills an ope.dLillg mPrh~ ... and the other of which contains a prefilled cartridge. The Op~,ldLillg mPch~nicm of the .device ",Pcl ~,~ir~lly advances an axially movable piston rod which, in turn, drives a piston plug located inside the cartridge so as to expel fluid from the device via a needle located at the bottom end of the body. The piston rod advances in sllccessive axial steps of fixed length through rotation of a rotatable piston rod nut. The piston rod nut is driven by a rotatable worm, which is rotated by the advancing axial movement of a pl~ u~ device located at the top of the elongated body.
The EPO application discloses a ~ ell~illg device somewhat similar to the Rex, et al. device, but embodies an opeldting mPch~ ." that co...~ es a pawl which permits relative movement of a ratchet-toothed l..~..,h~, in a snhst~nti~lly rectilinP~r ar-g~llP II As in the Rex, et al. device, the OpC.dLillg m~ch~ni~m drives the plunger of a mP-lir~m.ont vial to expel fluid Lll~ rlulll.
U. S. Patent No. 4,813,937 issued to Vaillancourt discloses an infusion system in which the inflow of fluid into the device causes an elastomeric member ~tr~rhP~l to a piston to be moved so as to stretch the elastomeric member. The thusly tensioned elastomeric member provides the source of energy to expel the fluid from the device when the outlet tubing of the system is opened. However, as is clear from a study of the Vaillancourt patent. the device disclosed therein operates in a substantially different manner than the device of the present invention. 4 Electrically operated syringe pumps are also well known, however, they are typically of considerable complexity and are de~isgn~od to inject very small doses of mPriirinP
with considerable accuracy over a long period, which may be up to 24 hours. Such syringe CA 02224124 1997-12-0~

W O 96/39220 PCTrUS96/09516 pumps do not provide the i,l~ te, simple and m~ml~liy operated device suitable for the slow injection of drugs over a shorter period of time, which may range from one to 15 ~ minutes.
Many of the prior art m~Air~nnPn~ di~ hlg devices are of complex construction and. therefore, are often very eA~e~ /e to m~mlf~rtllre. Additionally, such devices tend to be somewhat unreliable in use and frequently have a limited useful life. In using certain of the prior art devices, m~in~ining sterility has also proven to be a problem.
As will be a~,cciat~d from the ~liccllssion which follows, the a~dldLus of the present invention uniquely ov~coll.es the drawbacks of the prior art by providing a novel, disposable di~,ns~l of simple but highly reliable coll~L,u~;Lion. A particularly illl~)OlidllL
aspect of the a~aldLus of the present invention resides in the provision of a novel, self-contained energy source in the form of a constant-force spring that provides the force I-~ces.c~,y to uniformly and precisely rlicpçnce solutions, such as insulin, from ~Ldlldd~d prefilled containers that can be conveniently loaded into the a~dldLus. Because of the simplicity of construction of the a~dldLus of the invention, and the straight-forward nature of the energy source, the a~alaLus can be m:lmlf~r~lred at low cost without in any way sacrificing accuracy and reliability.
A so~ wl.at similar mP~ir~mPnt di~ensel is disclosed in co-pending application Serial No. 08/349,496 filed by the present inventor. This application is hereby incorporated herein by reference as though fully set forth herein. Reference to this earlier-filed application will show that the device of the present invention embodies a stored energy means of quite a different construction and mode of operation than that disclosed in Serial No. 08/349,496.
Summarv of the Invention ~t is an object of the present inv~ention to provide a small, compact fluid CA 02224124 1997-12-0~

di~l,ense~ for use in controllably dispensing fluid mP-iic~ Pll~s, such as insulin, antibiotics, oncolytics and the like from a prefilled container at a unirollll rate.
Another object is to provide a device of the afolclllclllioned character which is of very simple construction and embodies a minimnm number of parts.
Another object of the invention is to provide a small, compact fluid ~ ce that is receivable within a housing to which a fill vial can be collue-;Led for filling the .ell~el with the fluid.
Another object of the invention is to provide a dispenser of in which a stored energy source is provided in the form of a stretchable, elastomeric member of novel coll~llucLion that provides the force nPcpss~ry to continuously and uniformly expel fluid from the prefilled container.
Another object of the invention is to provide a di~e.lsel of the character d~s~;libed in the preceding paragraph in which the cla~l~Jlll~:,ic Ill~.llber is uniformly and controllably stretched by a novel ~LIc~l~ g Illpcll;~ni~lll and, after being stretched, exhibits a tendency to predictably return toward it original configuration.
Another object of the invention is to provide a di~ellsel of the class described which inrhl(l~Ps a fluid flow control assembly that filters and precisely controls the flow of the mP-1ic~mPnt solution from the prefilled container.
Another object of the invention is to provide a fluid dispenser which is adapted to be used with conventional prefilled insulin drug vials to deliver an insulin solution ~h~"~rlulll in a precise and sterile manner.
Another object of the invention is to provide a fluid dispenser of the class described which is compact, lightweight, is easy for ambulatory patients to use, is fully disposable, and is extremely accurate so as to enable the infusion of precise doses of insulin over ~lc~;lil)ed periods of time.

CA 02224124 1997-12-0~

W O 96~9220 PCT~US96/09516 Another object of the invention is to provide a self-contained m~llir~mPnt pçn~er which is of very simple col~Llu~;Lion and yet ~Ll~"llely reliable in use.
Another object of the invention is to provide a ~ c l~el of the class described which includes means for interco.-,.P~'i..g the device with the body or clothing of the patient.

Another object of the invention is to provide a fluid dispenser as described in the preceding paragraphs which is easy and i~Xllen~ive to m~m-fartllre in large qll~nthitos.

Brief Description of the Drawin~s Figure 1 is a generally p~ ,eclive, exploded view of one embodiment of the di~l,ensillg apparatus of the present invention for dis~ensillg fluids at a uniform rate.
Figure 2 is a cross-sectional, exploded view of the di~ellsillg head portion of the a~ Lus of Figure 1.
Figure 3 is a view taken along lines 3-3 of Figure 2.
Figure 4 is an enlarged, side-elevational. cross-sectional view of the assembled apparatus of the form of the inven~ion shown in Figure 1.
Figure 4A is an enlarged, side-elevational, cross-sectional view of the forward portion of the apparatus illustrating the appearance of the various components during the filling step.
Figure S is an enlarged side-elevational view similar to Figure 4, but showing the apparatus filled with the fluid to be dispersed.
Figure 6 is a generally perspective, exploded view of an alternate embodiment of the dispensing a~~,ardtus of the present invention for dispensing fluids at a uniform rate.
Figure 7 is a fragm~nt~ry, cross-sectional, exploded view of the forward portion of the apparatus inrlu~ling the di~enshlg head.

CA 02224124 1997-12-0~

W O 96/39220 PCT~US96/09516 Figure 8 is a view taken along lines 8-8 of Figure 7.
Figure 9 is a view of the rate control element side of fluid flow control assembly of the apparatus.
Figure 10 is a side-elevational, cross-sectional view of the fluid flow control assembly of the appa,~tus.
Figure l l is a front view of the filter element side of the fluid flow control assembly of the appa-dlu~.
Figure 12 is an enlarged, side-elevational view of the assembled ap~alaLus of the forrn of the invention shown in Figure 6.
Figure 13 is an enlarged, side-elevational view similar to Figure 12, but showing the apparatus filled with the fluid to be di~ ed.
Figure 13A is a fr~ ;..y, side-elevational view of the forward portion of the device as it appears during the fluid ~ e..~i..g step.
Figure 14 is a gen-or~lly pe.~e~;Li~e, exploded view of still another embodiment of the di~ensillg appaldL~Is of the present invention for dispensing fluids at a rate.
Figure 15 is a top plan, exploded view of the housing of the apparatus partly broken away to show internal construction, and of the fluid expelling and fluid filling suh~csemhlies of the a~al~-tus.
Figure 16 is a right end view of the apparatus shown in Figure 14.
Figure 17 is an enlarged, generally p.,.~eeLive exploded view of the fluid dispensing head and flow control means of this latest form of the invention.
Figure 17A is a cross-sectional view taken along lines 17A-17A of Figure 16.
Figure 18 is a generally perspective view of still another embodiment of the di~ellsing apparatus of the present invention for di~L~e~ g fluids at a uniform rate.

CA 02224124 1997-12-0~

W O 96~9220 PCTAJS96/09516 Figure 19 is a genPrally p~ ec~iv~, dia~ r view ill~ i..v the manner in which a portion of the ol)eldLillg member of the apparatus is advanced by the user ~ into the body of the ~aldLus.
Figure 20 is a fr~g...~ .y, generally pel~e~;Li~e view of the left-end portion of the ap~)dldLus shown in Figure 18 illustrating rotational movement of the end portion and further illustrating the direction of the force n~res~ry to operate the locking mPrh~ni~m of the device.
Figure 21 is a generally p~ e~;Li~re, exploded view of the appdldLus of the invention shown in Figure 18.
Figure 22 is an enlarged, left-end view of the apparatus shown in Figure 1.
Figure 23 is an enlarged, cross-sectional view taken along lines 23-23 of Figure 22.
Figure 24 is a cross-se~;Liondl view taken along lines 24-24 of Figure 23.
Figure 25 is a cross-sectional view taken along lines 25-25 of Figure 23.
Figure 26 is a cross-sectional v;ew taken along lines 26-26 of Figure 23.
Figure 27 is a cross-sectional view taken along lines 27-27 of Figure 23.
Figure 28 is a cross-sectional view taken along lines 28-28 of Figure 23.
Figure 29 is a cross-section~l view taken along lines 29-29 of Figure 23.
Figure 30 is a cross-sectional view taken along lines 30-30 of Figure 23.
Figure 31 is a cross-sectional view taken along lines 31-31 of Figure 23.
Figure 32 is a development view taken along lines 32-32 of Figure 31 illusLIdthlg the manner in which the locking teeth and locking tabs of the device cooperate to lock the operating member to the housing.
Figure 33 is an enlarged, cross-sectional view similar to Figure 23, but showing the position of the component parts of the apparatus after a portion of the Op-,-dLillg CA 02224124 1997-12-0~

be. has been threadably advanced into the body.
Figure 34 is a fr~gm.ont~ry, cross-sectional view of the di~ g end portion of the dp~aldLus illu~LldLillg the position of the COu~ ldtillg colllL,ollenl parts after the cannula has pierced the pierceable septum of the m~oAiC~mpnt vial.

Description of the Invention Referring to the drawings and particularly to Figures 1 through 5, one embodiment of the m~r~ic~m~nt delivery system of the present inveMion is there illustrated and generally c~esign~te-l by the mlmPral 12. This embodiment is somewhat similar to that described in the parent application No. No. 08/349,496 which is incorporated by .~fe.~ ce.
However, the forms of the invention shown herein are quite small, very compact, easy to use, and are of a less complex construction than those illustrated and described in the parent application.
The ap~a.dLus of this latest form of the invention col-.~ es a container 14, having a first open end 14a and a closed end 14b. End 14b is closed by an end wall 14c having a centrally disposed socket like portion 14d and a vent "V" for venting the interior of the container to atmosphere. Received within a reservoir-defining chamber 14e of container 14 is the stored energy means of this form of the invention, the purpose of which will pre-sently be described.
First end 14a of the container is closed by a fill and dispensing means for filling ~h~mber 14e with fluid and for di~en~ g fluid Lhelt:lrulll. The fill and di~lJe..~illg means here comprises a dispensing head assembly generally ~lesisgn~tt-d by the numeral 18.
As best seen in Figure 2, assembly 18 includes a closure cap 20 which is receivable over container 14 in the manner shown in Figures 4 and 5 Disposed within cap 20 is a flow control means for controlling the outward flow of fluid flowing from the reservoir or -CA 02224124 1997-12-0~

W O 96/39220 PCTrUS96/09516 internal çh~mher 14e of container 14. The flow control means of this embodiment of the invention comprises a gentorally annular shaped flow rate control e!ern~nt 24 and a gen~r~ily annular shaped filter çlem~nt 26. The flow colltrol means fur~er in~hl~es valve means which are supported within head assembly 18 by an al.elLul~,d support 27 which ~u~olL~ the made up of elements 24 and 26 and a bore 20a provided in the forward wall 20b of cap 20 (see Figure 4). In a manner prtselllly to be described, the valve means filnrtio~c to block fluid flow beLwcell reservoir 14e and the fluid passageway 30a of a luer c~.nl~e.;L~,l 30 which extends ouLwaldly from wall 20b of cap 20 and defines the fluid inlet 30b of the device. The valve means here conl~l;ses a valve member 32 having a neck portion 32a and a seat eng~ging portion 32b which sealably engages a valve seat 34 formed internally of bore 20a.
Turning to Figures 3 and 4A it is to be noted that bore 20a includes a plurality of circumferentially spaced bypass flow channels 35 which permit fluid flow into reservoir 14e when valve .. lhel 32 is moved lchlwaldly away from seat 34 in the manner shown in Figure 4A. As seen in Figure 3, cap 20 is provided with an annular collector manifold 36 having micro-ch~nn~olc 38 that direct fluid flow from reservoir 14e toward the outlet port 40 of the device via a fluid passage~way 41. Connected to outlet port 40 is a delivery conduit 42 having at its OuLboald end a male luer fitting 43 which mates with a female luer cap 45.
Disposed within reservoir 14e of the container 14 is the important stored energy means of the invention, which functions to urge fluid contained within the reservoir outwardly of the device via the flow control means. This unique stored energy means here cc~ es a specially configured elastomeric spring-like member 48 which is movable from a first configuration shown in Figure 4 to a second, more colll~ ed configuration shown in Figure S wh~,.cill it has a tendency to return toward its first configuration. As best seen CA 02224124 1997-12-0~

W O 96/39220 PCT~US96/09516 in Figure 1, member 48 co",pli~es an elongated col.,~.~ssible member having a plurality of longi~lrlin~lly spaced apart grooves and ridges 48a and 48b .c~e~ tely.
As ~ii.ccllcc.--l in U. S. Serial No. 08/349,496, which is incorporated herein by reference, the stored energy means can be constructed from a wide variety of materials inrhl-ling rubbers, plastics and other thermoplastic elastomers (TPE) and thermoplastic urethane (TPU). By way of example, suitable materials include latex rubber, rubber polyolefins, polyisoprene (natural rubber), butyl rubber, nitrile rubber, polyurethane, vinyls, vinyl-end-blocked polydimethylsiloxanes, other homopolymer, copolymers (random alLt;.~Ling, block, graft, cross-link and star block), silicones and other flouropolymers, "~ch~ni~ poly-blends, polymer alloys and hl~ GlleL.dting polymer networks.
In operating the apparatus of the form of the invention shown in Figure 1 through 5, with the outlet conduit 42 closed by luer closure cap 45 (Figure 4), a suitable filling tube "FT" and luer co~ule~;Lor "LC" (Figure 4) is h,L~.~o,l,lected with luer fitting 30 to enable filling of reservoir 14e with the fluid to be ~licpen.ced During filling, valve mPmher 32 will move away from seat 34 and into engagement with a central wall portion 27a provided on support 27 (Figure 2) thereby permitting fluid to flow from the fill tube past valve member 35 via bypass ch~nn~olc 33 and into reservoir 14e.
As the fluid under pressure flow through bypass channels 35, and into reservoir 14e, it will engage the forward piston-like portion 48c of the s~ored energy member 48 urging portion 48c inwardly of reservoir 14e. As the fluid under pressure urges piston portion 48a telescopically of the reservoir, the body portion of the stored energy member will be co~ c~scd in the manner inrljc~rPd in Figure 5. When fluid flow ceases through fill tube 52, check valve member 32 will be urged by the fluid ~lt;;S~Ul~ within reservoir 14e into seating engagement with valve seats 34 thereby sealing the inlet port of the device so that the fluid "F" which is to be ~li.cpencecl will be contained within reservoir CA 02224124 1997-12-0~

14e.
Following the filling step, a closure plug assembly "CP" is conn~-ctrA with luer fitting 30 so as to sealably close inlet 30b. As best seen in Figure 1, closure plug assembly "CP" co~ -ises a cap 50 which includes a multiplicity of ch.;u,ll~lcllLially spaced locking fins 50a which are lockably received within a multiplicity of ch~ re.ellLially spaced locking tabs 51 provided on assembly 18 (Figure 1). With this col~LlucLion, following filling, cap assembly "CP" is locked to assembly 18.
Upon opening the fluid delivery path by removal of closure cap 45 (Figure 4)?
the stored energy means, or .. - ..h~ 48, will tend to return to its ullcol~ essed starting configuration thereby controllably urging fluid flow uu~wdl.lly of the device via apclLu.es 27b in support 27, via rate control e~emlont 24 and via filter elrmPnt 26. Fluid flowing through these ele...e-lls will flow into annular shaped fluid collection passageway 36 and then uulwardly of the device via the delivery tube 42. Filter 26 which functions to filter particulate matter from the fluid flowing culw~-dly from ~ el~/oiL 14e is of a ch~r~rtrr well known to those skilled in the art and can be constructed from various readily available materials such as polysolfone and polypropylene wafers having a desired porosity.
Similarly, rate control elem~ t 24 can be consltructed from any suitable porous material such as pol~/carbonate. a metal or a ceramic having the desired porosity.
As before various fluids can be AicrenceA from container 14. including, by way of example, beneficial agents such as mPAir~mrntc of various types, drugs, ph~rm~relltir~lc, hormones, antibodies, biologically active materials, elements, rh~mir~l compounds, or any other suitable material useful in diagnostic cure, mPAir~tion, ~ ..l or preventing of Aice~cPs or the m~illlrl~nre of the good health of the patient.
Turning next to Figures 6 through 13 of the dl~whlgs, still ano~her form of the di~.lsh.g ap~a.~LLus of the present invention is there illustrated and generally Aecign~tloA

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by the numeral 60. The ~al~LuS of this ~IttornAt~ form of the invention is also similar in certain ,e~e~;L~ to the previously described embo-limPntc of the invention.
The a~aldLus of this latest form of the invention, like the embodiment just described, culnl!lises a container 62, having a first open end 62a and a closed end 62b and a fluid reservoir 62c disposed between ends 62a and 62b. End 62b is closed by an end wall 62d provided with a gas vent 63 for venting any gases contained within reservoir 62c to atmosphere. Vent 63 can be constructed of a suitable porous material such as a porous plastic. Received within reservoir 62c is the stored energy means of this form of the invention, the cllald~;LcL of which will p~cscllLly be described.
First end 62a of the container is closed by a fill and di~l,ensillg means shown here as a head assembly generally (lesignAtP~ by the numeral 64. As best seen in Figure 7, head assembly G4 is of a slightly different con~L.-IL;Lion than the previously described fill and ,cn~il)g head and inrlnrles a closure cap 66 which is receivable over end 62a of collL~ine 62 in the manner shown in Figure 12. Disposed within cap 66 is a flow control means for controlling the ouLwald flow of fluid flowing from the l~sel~oi. or internal chamber 62c of container 62. The flow control means of this embodiment of the invention comprises a generally annular shaped flow rate control element 67 and a generally annular shaped filter el~m~nt 68. The flow control means further inri~ s a support member 70 which is disposed between, and provides support to, rate control element 67 and filter element 68.
As shown in Figure 10, support ...~I..h~l 70 is provided with a plurality of circumferentially spaced fluid flow passageways 70a.
Cap 66 is provided with an annular shaped fluid collection channel 72 which is in co.. ~ Ation with passageway 70a and also with the outlet port 73 of the device.
Collnc~L~d to cap 66 proximate outlet port 73 is a hollow infusion needle 74 which is le~;Lively surrounded by an integrally molded twist off cap 75 and a closely fitting closure CA 02224124 1997-12-0~

W O 96/39220 PCT~US96/09516 sleeve 77, which cooperate to m~int~in the needle in a sterile condition and prevent fluid flow until time of use.
Disposed within rh~mher 62c of lhe container is the important stored energy means of the invention, which functions to urge fluid contained within reservoir 62c outwardly of the device via the flow control means and infusion needle 74. This unique stored energy means here co~ylises a specially configured sponge like mrmber 78 which is movable from a first configuration shown in Figure 12 to a second, more col..ylc:ssed configuration shown in Figure 13 wh~,eh~ it has a tendency to return toward its first configuration.
As previously r~icc--Ccec~ the stored energy means, including the stored energy means of this latest embodiment of the invention, can be constructed from a wide variety of materials inrlnrling rubbers, plastics and other thermoplastic elastomers (TPE) and thermoplastic u.eLl.alle (TPU).
In o~eldtillg the apydldLus of the form of the invention shown in Figures 6 through 13, with the fluid passageway of needle 74 closed by closure sleeve 77, reservoir 62c is filled with the fluid to be dispensed using a syringe having a needle adapted to yencL~dLe a centrally disposed, peneL.dble septu~,n 80 which is mounted within a central bore 66a provided in cap 66.
As the fluid under yl~ ur~: flowing from the filling syringe (not shown) enters reservoir 62c, it will engage a piston-like ~ lllibe. 82 which is telescopically movable longin~ n~lly of reservoir 62c. This fluid under pressure will urge member 82 telescopically inward of the reservoir causing the stored energy member to be col~y~._ssed in the manner in-~ir~t~d in Figure 13.
Upon removing twist off cap 75 and closure sleeve 77 from the needle thereby opening the fluid delivery path of the device. stored energy member 78 will tend to return to CA 02224124 1997-12-0~

W O 96/39220 PCT~US96/09516 its unco,l,pl~,ssed, starting configuration thereby controllably urging fluid flow uuLwdldly of reservoir 62c via filter element 68 and rate control element 67. Fluid flowing through these elPmPnt~ will next flow into annular shaped fluid passageway 72 and then outwardly of the device through infusion needle 74. Filter 68 which functions to filter particulate matter from the fluid flowing outwardly from reservoir 62c is of the character previously descrlbed herein as is rate control elem~ont 67. As before, the various fluids previously i~ ntifi.od herein can be dispensed from reservoir 62c. During the delivery step, the infusion needle is, of course, inserted into the vein of the patient. To stabilize the device, cap assembly 64 inrlnrles a curved base portion 64a which can be affixed to the patient by an adhesive layer 64b which is ~ tected prior to use by a peal strip 64c (Figure 13A) Turning now to Figures 14 through 17A, yet another embodiment of the invention is there shown. The ~ Jel~ lg means of this embodiment is somewhat similar to that shown in Figures 1 through 5, but the fill means of the apL)dldtus is quite different.
More particularly, the fill means here cul"~lises a separate fill assembly 81 (Figure 15), which is insertable into a ch~mher formed in a housing 83 of novel construction. As best seen in Figures 14 and 15, honeing 83 includes a base portion 83a and an upper body portion cover 83b having first and second iongihl/lin~lly e~tr~ ing internal chambers 83c and 83d which are suitably vented to atmosphere by vents "V" Formed within chamber 83c is a fluid reservoir 84 having a first open end 84a and a closed second end 84b (Figure 17A).
First end 84a is closed by a closure cap assembly 86 of the character shown in Figures 14, 15, and 17, which assembly colll~,lises a part of the dispensing means of this embodiment of the invention.
Cap assembly 86 includes a hollow cap 87 which carries the flow control means of this form of the invention for controlling the flow of fluid outwardly of reservoir 84. The flow control means here col"~,ises a generally disc shaped flow rate control wafer CA 02224124 1997-12-0~

W O 96~9220 PCTAJS96/09516 88 and a generally disc shaped filter wafer 89 which are ~ olLt:d in a back-to-back relationship by an ape-Lul~d support member 90. As shown in Figure 17, ~..c..-b~. 90 is provided with a plurality of ci..;u,l.fcl~llLially spaced flow passageways 90a to permit fluid flow toward the ~ r assemblage made up of wafers 88 and 89.
In this latest form of the invention, cap 87 inrhldr~s a plurality of radially e~ctr~n~lin~ support ribs 87a for ~.u~o~Li~g the iFlow control means. Cap 87 also inrhl~les a centrally disposed outlet, or fluid delivery por~ 92, to which a suitable delivery tube (not shown) can be co,n-r---lrd (Figure 17). The flow control means here Op~,~aLcs in the same maimer to accomplish the same result as does the flow control means considered in connec-tion with the earlier described embollimr~ntc of the invention.
Disposed within ~cse.voi, 84 is the important stored energy means of the invention, wh.ch ~lnr-ti-)nC to urge fluid contained within the ..,~.~,.vui. uulw~dly of the device via the flow control means and delivery port 92. This unique stored energy means here co~ es a specially configured r~ lllr lic spring-like m-onnhçr 94 which is movable from a first e?~p~nrlr~A configllration shown in Figure 15 to a second, more co~ lc~.~.cd configuration shown in Figure 17A wh~ it has a tendency to return toward its first configuration. As best seen in Figure 15, Ill~.llhel 94 co",p.i..es an elongaoed body having a plurality of lon~ih-rlin~lly spaced apart grooves and ridges 94a and 94b .e~ecLivcly. Once again, the stored energy means can be constmcted from a wide variety of materials inr~ln~ing rubbers, plastics and other thermoplastic elastomers (TPE) and thermoplastic urethane (TPU). The forward end 94c of member 94 engages a piston-like member 95 which is telescopically movable within chamber 83c of body 83.
Receivable within the second longih-r~in~lly e~trnr~ing ch,.mher 83d of housing 83 is the previously mentioned fill means of l:he invention. This novel fill means inr Indes fill vial assembly 81 which co~ .ises a fill vial 99 having a first open end 99a and a second CA 02224124 1997-12-0~

W O 96/39220 . PCT~US96/09516 closed end 99b. Fill vial 99 also inr!~ os fluid reservoir 99c within which a plunger-like n~,lllbel 100 is telescopically movable from a first position to a second position. Plunger 100, which is constructed of a non-coring claslolneL~ is adapted to be pierced by an elongated hollow needle 102 which extends longinl-lin~lly of ch~mher 83d of housing 83 in the manner shown in Figure 17A.
In Op~,laLillg the a~ldLus of the form of the invention shown in Figures 14 through 17A, with the outlet port of the device closed as, for example, by a cl~mre~l delivery tube, reservoir 84 can be filled by removing sterile safety cap 103 (Figure 15) and inseliillg vial 99 into opening 83e of ch~rnher 83d of housing 83. As the vial, which has been previously prefilled with the fluid to be ~ ensed. is urged inwardly of chamber 83d, needle 102 will pierce pierceable plunger 100 in the manner shown in Figure 17A.
Co.~ inward movement of the vial will cause the plunger to engage an internal stem 83f which is formed intf rn~ily of ch~..b~l 83. Stem 83f will force plunger 100 inwardly of the vial from the position shown in the phallLulll lines of Figure 17A to the position shown in the solid lines. This telescopic movement of plunger 100 will cause the fluid contained within reservoir 99c to be forced into the internal fluid passageway 102a of hollow needle 102. As best seen in Figure 15, passageway 102a of the needle commlmir~tçs with passageway 105 formed in stem 83f and then into a transverse passageway lOSa formed internally of housing 83. Passageway 105a is, in turn, in collllllllllir~rion with reservoir 84 so that fluid flowing from vial 99 will flow into and fill reservoir 84.
As the fluid under plcS:jul~ flows into reservoir 84, it will engage a piston-like ..-~-.~hei 95 which will, in turn, COlllL)l~,SS stored energy m~mher 94 in the manner shown in Figure 17A. When vial 99 is fully seated within chamber 83d, a cooperating split ring 103a (Figure 15) will securely lock the vial in place within chamber 83d in the manner shown in Figure 17a.

CA 02224124 1997-12-0~

W O 96~9220 PCTAJS96/09516 Upon opening the c!~mrled fluid delivery tube, the stored energy means or member 94, will tend to return to its ~ co~ lc~.sed starting configuration thereby controllably urging piston 95 to move telescopically within lese.~oi, 84 this telescopic movement of piston 95 will cause the fluid contained in the lc~.el~/oi~ to flow oulwdldly of the device via rate control e!em~nt 88 and filter cl~...,..~ 89. Fluid flowing through these rl~ will flow into an armular shaped fluid passageway 107 formed in cap assembly 86 and then uuLwdl.lly of the device via outlet port 92.
Turning once again to Figures 14 and 15, it is to be observed that body portion 83b of the housing is provided with a Lldll:~Jdl~ lL indicia carrying portion 108 which culll~ .es a part of the ;-~ t~-L means of the: invention for in-lir~ting the amount of fluid cont~in~l within reservoir 84. Since reservoir 84 is visible through cover portion 108, the location of m.omher 95 within reservoir 84 can be observed in relation to the indicia 108a provided on portlon 108. In this way, at any point in time, the amount of fluid rPm~ining within the reservoir can be readily ascertained.
An ait~rn~t~ filling and drug recovery means for either filling ~eP,el ~/oi~ 84 or for recovering drugs th~,.cr,ulll is also here provided. This ~ItPrn~t~ means culll~ es a septum assembly 109 which is carried within a septum receiving chamber lO9a provided in the side wall of cover 83b (Figures 14 and lS). Chamber lO9a is in co~ r~tion with passageway 105a of hollcing 83b so that fluidl under pl~ .ulc introduced into passageway 105a through the use of a syringe, the needle of which has pierced septum 109b of the septum assembly, will flow under ~ Ul~ into reservoir 84. As before, this fluid flowing into reservoir 84 will impinge upon piston 9S moving it telescopically inwardly of the reservoir and controllably colll~ .illg the stored energy member 94. After being thusly colll~lcssed, the stored energy member can function to controllably expel fluid from the device during the delivery step. In similar fashion, drugs can be removed from the reservoir CA 02224124 1997-12-0~

using a syringe and thereby ~eco~ d if desired. As shown in Figure 15, septum lO9b is retained within chamber 109a by a retaining cap lO9c which is ~p~ iat~ly bonded to cover 83b (Figure 17A).
Co~ lisi-lg a part of the housing assembly is means for affixing the device to the patient. This means here cullll..ises a sponge pad 110 having adhesive covered surfaces 110a and 110b (Figure 14) . Pad 110 is receivable within an opening 111 formed in base 83a so that the adhesive covered sponge can bond the cover assembly to base 83 and also bond the assemblage to the patient.
The housing assembly itself can be constructed from various materials including polycarbonate, acrylic, polystyrene and the like. Vial 99 is preferably constructed from glass or suitable plastic materials. Plunger 100 can be constructed from aL~ ia~c elastomers such as rubber or silicon.
Needle 102a is p.ef,lably made from st~inl~cc steel and may be a sharp or blunt end c~nmll~
Referring next to Figures 18 through 33, still another embodiment of the m~ ir~m-?nt delivery system of the present invention is there illustrated and generally cign~ted by the numeral 112. The a~a.~Lus of this form of the invention co...p,iaes an elongated body 114, which is made up of three hll~..;o~ Fcle~l, generally tubular shaped portions 116, 118, and 120 ~c~e~ ely, portion 120 co~nL,.iaes a part of the operating means of the invention, the purpose of which will p~cscl~lly be described. As best seen by referring to Figure 23, when portions 116, 118, and 120 are h.le.~;olulecLcd to form elongated body 114 they define first, second and third co~ lu~icating interior chambers 122, 124, and 126 .esl,e~Li~ely.
Removably receivable within a top opening 122a of first chamber 122 (Figure 21) is a prefilled m~ m-ont vial 130 having a first end 130a sealed by a pierceable member CA 02224124 1997-12-0~

W O 96/39220 PCT~US96/09F.16 132 and a second end 130b sealed by an elastomeric plunger 134 which is telescopically movable longin~riin~lly of the internal fluid reservoir or chamber 130c of vial 130.
Pierceable member 132 comprises a part of t'ne outlet means of the reservoir for pe ...;~ g fluid flow therefrom.
Disposed witnin second ch~mher 124 of elongated body 114 is plunger en~ ing means for moving plunger 134 of the vial assembly axially of chamber 130c. The details of construction and operation of this plunger ~ng~ging means and its interrelationship with the operating means will presc.lLly be described. Also disposed within second clldl.lbel 124 of the elongated body is the novel stored energy means of the invention, which provides energy nPcPcc~ry to move plunger 134 longinlriin~lly of reservoir 130c. This unique stored energy means here co~ ises a controllably stretchable el~ctomPric, dome-like mPmher 137 which is stretchable from a first configuration. shown in Figure 23 to a second, .L-~L~hed configuration shown in Figure 33 wl.t.c;n it has a tendency to return toward its first configuration. The method and a~>aldLus for controllably ~.LI~t~;hing el~ctomPric mPmher 137, which includes mPmhPr 120 and its finger-eng~ging portion 120a (Figure 18), will be described in the paragraphs which follow.
Also comprising an important aspect of the apparatus of the present form of the invention is flow control means for controlling the outward flow of fluid flowing from the reservoir or internal chamber 130c of vial 130. This flow control means here co~ lises a body portion provided in the form of an end cap assembly 140 which is threadably interconnectable wi~h body portion 116. As best seen by ~ lhlg to Figure ~1. cap assembly 140 comprises an internally threaded cap 142 having a fluid outlet 144 and de~lning an interior chamber 146. Disposed within chamber 146 and forming a part of the flow control means of the invention is a cannula assembly 148 which comprises a hollow cannula 150 and a cannula support plate 152. C~nnni~ 150 can be either a conventional, CA 02224124 1997-12-0~

W O 96/39220 PCT~US96/09516 sharp, hollow needle or a blunt end cannula of a chald~;Ler well known in the art. C~nm assembly 148 is held in position within cap 142 by sonic bonding or the like. Disposed adjacent plate 152 is a spacer means, shown here as a coln~ ible, elastomeric spacer plug assembly 154, which includes a pierceable membrane 154a that is receivable within the mouth of cap chamber 146 in the manner shown in Figure 23. Prior to the cap assembly being interconnected with body portion 116 interior chamber 146 of the cap assembly is preferably closed and m~int:~into-l in a sterile configuration by a tear-away cap of col~Llu_Lion well known to those skilled in the art.
Disposed b~Lweel1 cannula support plate 152 and an end wall 142a of cap 142 (Figure 23) is a filtering and flow rate control means for filtering and controlling the rate of fluid flow ouLwa~dly through outlet 144 of cap 142. This filtering and fluid rate control means co~ ,ises a part of the fluid flow control means of the invention and, in the forrn of the invention shown in the dlawing~ inrlllriPs a rate control filter 161. Rate control 161, which can be constructed from any suitable porous material such as a polycarbonate, a metal or a ceramic, is supported by a support plate 163 carried within chamber 146. In some rec, additional filtration is desired u~Ll~âlll of rate control ekPmPnt 161 and in those incr~nr~Ps a porous filter is placed u~sLl-,alll of elPmPllt 161. This filter can be of the character shown in Figure 15 and ~l~Pcign~tPd by the numeral 89. Support plate 163 can be constructed from any suitable porous material of a character well known by those skilled in the art as, by way of example, porous polypropylene, porous polycarbonate. and porous polysulfone and non-porous polyamide sold under the name and style KAPTON.
In using the apparatus of the invention shown in Figures 18 through 30 the component parts of the appar~Lus are assembled in the manner shown in Figure 23. More particularly, fluid vial 130 cont~inin~ a fluid such as the mP-lir~mPnt "M", which may be insulin. al,lil)io~ics, analgesics. oncolytics, human growth hormones, gerlptir~lly enginee.ed CA 02224124 1997-12-0~

W O 96/39220 PCT~US96/09516 biologic agents, or any other type of ifljectdbl~: beneficial agent, is inserted into first chamber 122 of the elongated body via top opening 122a. End assembly 142 is then threadably interconnPctP~ with body portion 116. Next, the plunger eng~ging means shown here as an elongated pusher member 170 is inserted into second chamber 124 in the manner shown in Figure 23. ConnPctPc~ to pusher member 170 is the novel stored energy means of the invention which is shown here as c!~lu.l~ .ic dome member 137. Dome member 137 inrln-lPs a dome or top portion 137a, a flange 137b and side walls 137c which interconnect portions 137a and 137b. Flange 137b is clamped within a groove 138a formed in a ring 138 which is slidably disposed within chamber 124 by a cylindrical portion 175 of the ~ ,dLing means which also extends into ch~mher 124. In this regard, it is to be noted that body 120 is provided with internal threads 172 (Figure 23) which engage external threads 174 that are formed on portion 177 of the o~eldLillg means which is connected to cylindrical portion 175.
Portion 177 is initially disposed within challlbFr 126 so that as portion 120 is rotated, it cooperates with threaded portion 177 to strategically advance portion 175 inwardly of chamber 124 causing telescopic movement of ring 138 longih~in~lly of chamber 124.
After the appaldLus has been assembled in the manner shown in Figure 23, a cylindrically shaped head portion 170a of pusher member 170 will engage portion 137a of elastomeric dome 137. Sim~lt~nPously, end 170b of the push rod will engage plunger 134 of the vial assembly in the manner shown in Figure 23. With this novel construction, and unlike the prior art devices, the stored energy means never contacts the fluid to be dispensed thereby preserving the sterile integrity of the reservoir contents.
At the start of the operation of the apparatus of this latest form of the invention, locking means, shown here as a push button assembly 180, is in the unlocked configuration shown in Figure 23. With the locking means in this unlocked position, rotation of member 120 relative to lllelllbel 118 and relative to portion 177 will cause CA 02224124 1997-12-0~

W O 96/39220 PCT~US96/09516 portion 177 to advance within chamber 124 from the starting position shown in Figure 23 to the extended position shown in Figure 33.
As best seen in Figures 21, 23, 24, and 33, portion 177 includes a plurality of longinl-lin~lly spaced splines 182 which, during operation of the device, are seql-enti~lly engaged by an interiorly ext~ ing tab 183 (Figures 21 and 24) provided on a forwardly e~rt.on-ling portion 198 of member 118. Splines 182 and tab 183 comprise the tactile sensing means of the invention for providing a tactile sensation as the stored energy means is stretched. It is also to be noted that portion 198 inr.lllri.os a bearing surface 118a upon which member 120 rotates.
As portion 177 of the opelaLillg means moves toward its advanced or extended position, it will urge travel of ring 138 over pusher member 170. However, when the outlet port of cap 140 is closed by closure 188 in the manner shown in Figure 23, fluid cannot flow outwardly of the outlet port. Accol-li.lgly, when the outlet is closed, the le~ i.n~e offered by the fluid within the vial reservoir to axial movement of plunger 134 will cause the pusher memher to controllably stretch wall 137c of elastomeric dome 137 in the manner shown in Figure 33. With this construction. upon opening outlet 144, only then will a fluid flow path be formed beLween the me~ ment reservoir of the vial and an infusion set or other delivery system 190 which is connected to cap 142 in the manner shown in Figure 34, thereby permitting fluid to be r~icpenc~d from the device. As before, expansion of the stored energy means provides the force nPcec~ry to cause the controlled movement of the vial plunger and the resulting discharge of the fluid contained within the vial. It is to be noted that a novel feature of the Op~,latillg means is that this means permits the stored energy means to be controllably expanded to any desired strain energy densi~y loading to enable precise solution of fluid flow rates. Indicia "I" are provided on members 118 and 120 so that the degree of loading of the stored energy means can be se!pcted CA 02224124 1997-12-0~

W O 96/39220 ; PCTrUS96/09516 Following the desired strain energy density loading of the stored energy means, portion 177 of the O~JC;ld~ g means can be locked in the extPn~lPd position shown in Figure 33 through operation of push button 192 of the locking means or locking assembly 180 in a marmer to push it inwardly into the open end of body portion 120. As best seen by referring to Figures 21 and 23, push button 192 inrhldPc an internal chamber 194 into which a generally cylindrically shaped extension 196 of portion 198 of member 118 extends. As best seen in Figure 21, portion 198 comprises a pair of spaced apart connector arms 198a and 198b which connect portions 118a and 196.
Formed on extension 196 are cil ~;ull,rt;l~ ially spaced, arcuaoe shaped ret~ining segmPnt~ 200 (Figure 21) which are [ockably eng~ge~hle with a first annular collar 202 formed within chamber 194. Also formed within chamber 194 is a second annular collar 204 which is eng~gP~ble by arcuate ret~ilning segments 200 when push button 192 is pushed inwardly of body portion 120 (Figure 33). To guide travel of push button 192 inwardly of body portion 120 and to lock the finger-eng~ging means against rotation with respect to member 118, the push button is provided with a keyway 206 (Figures 21 and 23) which slidably receives a key 208 formed within interior chamber 126 of body portion 120.
Also forming a part of the locking means of this form of the invention. is a non-rotatable locking ring 210 which is affixed to extension 196 as by sonic bonding. As in~lir~tPd in Figure 21, ring 210 is provided with circumferentially exten~ling teeth 210a which lockably engage serations 212 provided within push but~on 192 when the push button is t'ully inserted as shown in Figure 33. RP~C~ e key 208 is locked within keyway 206, rotation of the push button relative to the member 120 is prevented. Therefore, when the push button is locked against rotation with respect to fixed ring 210, rotation of member 120 is also positively prevented.
During the fluid delivery step, the stored energy source or ~ ;hed CA 02224124 1997-12-0~

W O 96/39220 PCTrUS96/09516 elastomeric dome member 137, will move pusher member 170 toward its initial starting configuration. This causes vial 130 to move from the position shown in Figure 23 to the position shown in Figure 33 wl~ cannula 150 pierces member 154a and septum 132 thereby opening a flow path beLw~ reservoir 130c and the fluid delivery means. The stored energy source will then cause plunger 134 to move axially of reservoir 130c from a first position shown in Figure 23 to a second position shown in Figure 34. As the plunger moves within the reservoir, the fluid contained therein will be urged into the fluid passageway 150 of cannula 150 and toward the flow control means of the apparatus (Figure 34). The fluid will then flow under pl~ 7UI~ through rate control 161 and then Oulwaldly of outlet 144 and into the fluid delivery means 190.
The various fluids that can be dispensed from vial 130c, include all those previously described, inrln-ling by way of example, benPfiriAI agents, such as mr-lifA,.....
of various types, drugs and pl~ ..Ar~.lirAI~.
With respect to the important stored energy means, as before a wide variety of materials such as those previously described, can be used to form the stored energy means inrln~ling synthetic polymers, latex rubber, synthetic rubber, rubber polyolefins, silicon plastics and other thermoplastic elasLolll~, (TPE) and thermoplastic urethane (TPU).
l~SAmlfArhlres of materials suitable for use in the construction of stored energy source. include Advance Elastomer Systems, Dow Chemical, General Electric, B.P.
Polymers. Mobay ChrmirAI, Shell Oil Corp., Petrarch Systems, DuPont. Akron Rubber, Concept Polymers and Union Carbide.
Turning particularly to Figures 21, 31, and 32 cap 142 is provided with threads 142t which threadably engage threads 116t provided on body portion 116 Cap 142 is also provided with circumferentially extrn~ling, flexibly deforrnable locking tabs 143 which are adapted to lockably engage locking teeth 116a provided on body portion 116.

CA 02224124 1997-12-0~

When the loc~king tabs 143 engage locking teeth 116a in the manner shown in Figure 32, removal of the cap is effectively ~ve~lL~d.
Turning next to Figures 18, 21, 22, and 29, the embodiment of the invention there shown co~ -ises a support means for removably supporting body 114. This support means here includes a supporting base assembly 214, which is llçsign~-d to be lockably illL~,..;ollllected with and securely support elongated body 118 in the manner shown in Figure 18. As best seen in Figure 21, base assembly 214 inrllldçs a curved base plate 216 which is provided with longih~llin~lly e~ctt~n-ling channel 218 and a locking assembly 220 which in.~ln~.os a transversely e~lr~ il.g release arm 222 having a locking protuberance 224.
T ockinE protuberance 224 is provided with a sloping face that is adapted to engage one of a plurality of outwardly e~cr~ ing locking teeth 2''6 (Figure 23) provided on the base of body member 118 as flange portion 118b of member 118 is slidably received within groove 218.
With this col~LIu~;lion, as flange 118b slides into groove 218 protuberance 224 will ratchet over teeth 226 until body portion 118 is finally seated within the base assembly.
At this point, the eng~ tooth will block ren.loval of flange 118b. However, upon de~l~ssing arm 222, plu~ube,dnce 224 will pivot dowllw~ldly about leg 225 (Figure 21) of the release mPçh~ni~m so as to move clear of the teeth so that body portion 118 can be .ong~ge~i from the base assembly.
Body 114 can be interconnected with other types of base assemblies which permit the hlL~.~;olllle~;~ion therewith of a variety of f~ct~ning devices that enable the aLuS to be readily hlhl~olulec~d with the body or clothing of an ambulatory patient.
Materials particularly well suited for the construction of the elongated body and the operating mPmhçr include polycarbonates, nylons, and acrylics. Preferred materials for the construction of the pusher-eng~ging member include polypropylene~ polystyrene and polyoxnyl chloride.

W O 96t39220 PCTAJS96/09516 Having now des~,libed the invention in detail in accordance with the Uil~,lllellLS of the patent statutes, those skilled in this art will have no tlifflrulty in making changes and morlific~tions in the individual parts or their relative assembly in order to meet specific requirements or conditions. Such ch~ngçs and moriifit~tions may be made without departing from the scope and spirit of the invention, as set forth in the following claims.

Claims

I CLAIM:

1. A dispensing apparatus for dispensing fluids comprising:
(a) a container ;
(b) a fluid reservoir disposed within said container. said reservoir having an outlet for permitting fluid flow from said fluid reservoir;
(c) a plunger sealably movable within said reservoir from a first position to a second position;
(d) stored energy means for acting upon said plunger to cause the fluid to controllably flow through said outlet means, said stored energy means comprising a compressively deformable, elastomeric member carried within said reservoir, said compressively deformable elastomeric member being expandable to cause fluid flow from said reservoir; and (e) fill means operatively associated with said container for filling said reservoir with the fluid to be dispensed.

2. An apparatus as defined in Claim 1 further including flow control means operatively associated with said container for controlling fluid flowing from said outlet means of said reservoir.

3. An apparatus as defined in Claim 1 in which said elastomeric member comprises a flexible polymeric member.

4. An apparatus as defined in Claim 1 in which said elastomeric member comprises a cellular mass.

5. An apparatus as defined in Claim 1 further including a housing having first and second chambers disposed side by side. said first chamber defining said container and said second chamber being adapted to receive a vial comprising a part of said fill means.

6. An apparatus as defined in Claim 1 in which said container comprises a vial having a first open end and a closed second end, said reservoir being disposed between said first and second ends.

7. An apparatus as defined in Claim 6 in which said fill means comprises a closure cap connected to said first end of said vial, said closure cap having a fluid outlet.

8. An apparatus as defined in Claim 7 in which said flow control means comprises a flow rate control element carried within said closure cap.

9. An apparatus as defined in Claim 7 in which said flow control means comprises a filter element carried within said closure cap.

10. An apparatus as defined in Claim 7 further including a fluid administration line with luer connector disposed in fluid communication with said fluid outlet.

11. An apparatus as defined in Claim 7 further including an infusion needle connected to said closure cap proximate said fluid outlet.

12. A dispensing device for dispensing fluid comprising;
(a) a container having a first open end and a closed second end and a fluid reservoir disposed between first and second ends;
(b) a fill and dispensing means connected to said first end of said container for filling said fluid reservoir with the fluid to be dispensed and for dispensing the fluid from said reservoir, said fill and dispensing means comprising a closure cap having a fluid outlet; and (c) stored energy means disposed within one of said fluid reservoir for acting upon the fluid contained therein to cause the fluid to controllably flow through said fluid outlet of said closure cap, said stored energy means comprising a compressively deformable, elastomeric member, said compressively deformable, elastomeric member being expandable to cause fluid flow from said reservoir toward said fluid outlet.

13. An apparatus as defined in Claim 12 in which said elastomeric member comprises a flexible polymeric member.

14. An apparatus as defined in Claim 12 further including flow control means carried by said closure cap for controlling fluid flow between said reservoir and said fluid outlet.

15. An apparatus as defined in Claim 14 in which said flow control means comprises fluid flow rate control means for controlling the rate of the fluid flow from said reservoir toward said fluid outlet.

16. An apparatus as defined in Claim 14 in which said flow control means comprises filter means for filtering particulate matter from fluid flowing from said reservoir.

17. An apparatus as defined in Claim 14 in which said flow control means comprises valve means for blocking fluid flow between said reservoir and said fluid outlet.

18. An apparatus as defined in Claim 17 in which said closure cap includes a central bore defining a valve seat and in which said valve means comprises a valve member movable within said bore toward and away from said valve seat.

19. An apparatus as defined in Claim 18 in which said closure cap includes a luer connector and in which said apparatus further includes a filling assembly interconnectable with said luer connector.

20. A dispensing apparatus for dispensing fluid comprising:
(a) a housing having first and second chambers, said first chamber including a fluid reservoir having an outlet for permitting fluid flow from said fluid reservoir;
(b) stored energy means for acting upon the fluid contained within said reservoir to cause the fluid to controllably flow through said outlet, said stored energy means comprising a compressively deformable, elastomeric member carried within said reservoir, said elastomeric member being expandable to cause fluid flow from said reservoir;
(c) fill means for filling said reservoir with the fluid to be dispensed, said fill means comprising a fill vial assembly receivable within said second chamber of said housing; and (d) dispensing means for dispensing fluid from said fluid reservoir, said dispensing means comprising a cap assembly connected to housing proximate said first chamber, said cap assembly including a hollow cap having a fluid outlet in communication with said outlet of said reservoir.

21. An apparatus as defined in Claim 20 in which said elastomeric member comprises a flexible polymeric foam member.

22. An apparatus as defined in Claim 20 further including flow control means carried by said hollow cap for controlling fluid flow between said reservoir and said fluid outlet of said hollow cap.

23. An apparatus as defined in Claim 20 in which said housing includes indicator means for indicating the amount of fluid contained within said fluid reservoir thereof.

24. An apparatus as defined in Claim 20 in which said housing includes a fluid passageway and in which said fill means further comprises an elongated hollow needle disposed within said second chamber, said hollow needle defining a flow passageway in communication with said fluid passageway of said housing.

25. An apparatus as defined in Claim 24 in which said vial assembly comprises:
(a) a vial having a first open end, a closed second end and a fluid reservoir disposed between said first and second ends; and (b) a pierceable plunger disposed within said vial for movement within said fluid reservoir from a first to a second position.

26. An apparatus as defined in Claim 24 in which said housing includes a septum receiving chamber in communication with said fluid passageway and a pierceable septum mounted within said septum receiving chamber for gaining access to said fluid passageway.

27. A dispensing apparatus for dispensing fluids comprising:
(a) a housing;
(b) a vial deployed within said housing, said vial defining a reservoir having an outlet for permitting fluid flow from said fluid reservoir;
(c) stored energy means for acting upon the fluid contained within said reservoir to cause the fluid to controllably flow through said outlet means, said stored energy means comprising a stretchable, elastomeric member carried by said housing, said stretchable, elastomeric member being contractible to cause fluid flow from said reservoir; and (d) operating means carried by said housing for controllably stretching said elastomeric member.

28. An apparatus as defined in Claim 27 further including flow control means carried by said housing for controlling fluid flowing from said outlet means of said reservoir.

29. An apparatus as defined in Claim 28 in which said vial has first and second ends between which a plunger is telescopically movable, said plunger being operably associated with said stored energy means.

30. An apparatus as defined in Claim 29 in which said reservoir outlet means comprises a penetrable sealing means for sealably closing said first end of said chamber.

31. An apparatus as defined in Claim 31 in which said flow control means comprises a pierceable cannula connected to said housing for penetrating sealing means.

32. An apparatus as defined in Claim 31 in which said flow control means is provided with a fluid outlet port and further includes flow rate control means disposed between said cannula and said fluid outlet port for controlling the rate of fluid flow from said fluid outlet port.

33. An apparatus as defined in Claim 32 in which said flow rate control means comprises a membrane having fluid passageways therethrough.

34. A dispensing apparatus for dispensing fluids comprising:
(a) a housing;
(b) fluid reservoir disposed within said housing, said reservoir having an outlet for permitting fluid flow from said fluid reservoir;
(c) stored energy means for acting upon said fluid contained within said reservoir to cause the fluid to controllably flow through said outlet means, said stored energy means comprising a stretchable, elastomeric member carried by said housing of said stretchable elastomeric member being contractible to cause fluid flow from said reservoir; and (d) operating means carried by said housing for selectively loading said elastomeric member to achieve a specific strain energy density loading of said elastomeric member.

35. An apparatus as defined in Claim 34 in which said elastomeric member comprises a synthetic polymer.

36. An apparatus as defined in Claim 34 in which said elastomeric member comprises a silicon.

37. An apparatus as defined in Claim 34 in which said elastomeric member comprises latex rubber.

38. A dispensing device for dispensing fluid comprising:
(a) an elongated body having a plurality of interconnected chambers;
(b) a fluid container receivable within one of said chambers, said fluid container having fluid outlet means and plunger means telescopically movable within said fluid container for urging fluid contained therein to flow out of said fluid outlet means;
(c) fluid flow control means carried by said elongated body, said fluid flow control means having an outlet port in communication with said fluid outlet means of said container for controlling fluid flow from said outlet port; and (d) stored energy means disposed within one of said chambers for controllably moving said plunger means telescopically of said fluid container, said stored energy means comprising a generally dome-shaped, elastomeric member having stretchable wall portion.

39. A device as defined in Claim 38 further including operating means for controllably stretching said wall portions of said elastomeric member.

40. A device as defined in Claim 39 in which said operating means comprises an operating member rotatably carried by said elongated body.

41. A device as defined in Claim 40 in which said elastomeric member comprises a polymer.

42. A device as defined in Claim 41 in which said fluid flow control means further comprises flow rate control means disposed between said fluid outlet means of said fluid container and said outlet portion of said flow control means for controlling the rate of fluid flow through said outlet port.

43. A device as defined in Claim 42 in which said fluid flow control means further includes filter means for capturing particulates contained with the fluid flowing through said outlet of said fluid container.

44. A device as defined in Claim 43 in which said first body portion of said elongated body is threaded and in which said fluid flow control means comprises a threaded cap threadably connected to said body portion.

45. A device as defined in Claim 43 in which said fluid container comprises a prefilled vial containing insulin, said vial having a first end sealed by a penetrable septum and a second end sealable by said plunger means.

46. A device as defined in Claim 45 in which said fluid container comprises a prefilled vial containing analgesic said vial having a first end sealed by a penetrable septum and a second end sealable by said plunger means.

47. A device as defined in Claim 45 in which said fluid container comprises a prefilled vial containing antibiotics, said vial having a first end sealed by a penetrable septum and a second end sealable by said plunger means.

48. A device as defined in Claim 45 in which said fluid container comprises a prefilled vial containing chemotherapeutic agents, said vial having a first end sealed by a penetrable septum and a second end sealable by said plunger means.

49. A device as defined in Claim 45 in which said fluid container comprises a prefilled vial containing radioactive dyes, said vial having a first end sealed by a penetrable septum and a second end sealable by said plunger means.

50. A device as defined in Claim 45 in which said fluid container comprises a prefilled vial containing hormonal agents, said vial having a first end sealed by a penetrable septum and a second end sealable by said plunger means.

51. A device as defined in Claim 45 in which said fluid container comprises a prefilled vial containing biologic agents, said vial having a first end sealed by a penetrable septum and a second end sealable by said plunger means.