CA2219884A1 - Fluid delivery apparatus and method of making same - Google Patents
Fluid delivery apparatus and method of making same Download PDFInfo
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- CA2219884A1 CA2219884A1 CA 2219884 CA2219884A CA2219884A1 CA 2219884 A1 CA2219884 A1 CA 2219884A1 CA 2219884 CA2219884 CA 2219884 CA 2219884 A CA2219884 A CA 2219884A CA 2219884 A1 CA2219884 A1 CA 2219884A1
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Abstract
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 distendable membrane (34), which, in cooperation with a thin planar base (32) defines a fluid chamber (46) having a fluid outlet. 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. The apparatus (30) also includes a highly novel fluid flow indicator (104) that provides a readily discernible visual indication of fluid flow through the apparatus (30).
Description
CA 022l9884 l997-lO-30 WO 96/34651 PCT/US~ ~6017 FLUID DELIVERY APPARATUS AND METHOD OF MAK~G SAME
SPECIFICATION
Background of The Invention This is a Continn~tion-In-part Application of a co-pending Application filed May1, 1995 which is a Co..l;....,.lion-In-Part of co-pending application, Serial No. 08/046,438, filed May 18, 1993; which is a Con~in--~tion-In-Part of Application Serial No. 07/987,021 which has now issued into Patent No. 5,279,558; which is a Co..~ tion-In-Part of Application 07/870,269 which has now issued into Patent No. 5,205,820; and which is, in turn, a Contin-~tion-In-Part of Application Serial No. 07/642,208 which has now issued into U.S. Patent No. 5,169,389; which is a Contin--~tion-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 conce~ an improved apparatus, inrhl-lin~ visual flow inflir~tor means, for infusing medicinal agents into an ambulatory patient at specific rates over extended periods of time.
Des~ lion of the Prior Art Many medicinal agents require an intravenous route for ".l.~ l. ation 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 col~ce-lLldtions has also increased the need for accuracy in controlling the delivery of such drugs. The delivery device, while not an active ph~rm:lrologic agent, may enh~nre the activity of the drug by m~ ting its therapeutic effectiveness. Certain classes of new ph~rm~rologic agents possess a very narrow range of theld~utic effectiveness, for in~t~nre, too small a WO 96/346Sl PCT/US96/06047 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 ~imini~tration sets and the familiar bottle suspended above the patient. Such methods are cumbersome, imprecise and require bed confinPment of the patient. Periodic moni~o,ing of the apparatus by the nurse or doctor is required to detect malfunctions of the infusion dpl)dl~lLUS.
Devices from which liquid is expelled from a relatively thick-walled bladder by internal stresses within the ~ t~n~efl 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 ~lifflrnlt and e~ell~ive to m~ r~. l---e and use. Further, the devices are somewhat unreliable and their fluid discharge rates are frequently h.lpiecise.
The apparatus of the present invention overcomes many of the drawbacks of the prior art by elimin~ting the bladder and making use of l~ct;nLly 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 clasL~llleric film membrane controllably forces fluid within the clldmber into fluid flow cll~nn~-ls provided in the base.
The el~lol..~lic film materials used in the dpparatus of the present invention, as well as various alternate constructions of the apl)dld~us, are described in detail in U. S.
Patent No. 5,205,820 issued to the present inventor. Theler{,l~" U.S. Patent No.5,205,820 is hereby incorporated by r~relellce in its ellLil~Ly 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 embo-limPnt~ of the invention. This co-pending application is also hereby incorporated by lefelellce in its ~Illilely as though fully set forth herein.
The apparatus of the present invention can be used with minim~l professional e in an alternate health care environrnent, such as the home. By way of example?devices of the invention can be comfortably and conveniently removably affixed to the CA 022l9884 l997-lO-30 WO 96/346Sl PCTIU33~ ~0'017 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 t precisely the correct qll~ntitiçs and at extended microfusion rates over time.
One of the embodiments of the invention described in Contin-l~tion-In-Part ~ application Serial No. 08/046,438 includes a highly novel, l~min~ stored energy means made up of a plurality of individual membranes. As before, this unique stored energy means cool,er~tes with the base to define one or more fluid leselvoil~ or chambers.
However, by constructing the stored energy means from a composite of several elements or layers, the elastic chalactelislics 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 sim--lt~nPously precluding any negative migration of selpcte~l atmospheric gases or vapors into the reservoir. Where the composite is made up of two or more layers of alte~ g thi- l~nPss and permeability, and the permeability con~L~ of the individual film layers are pressure depPn~1Pnt, the permeability of the stored energy means is effected and the direction of flow of the permeant through the membrane wall is controlled by the order in which the individual layers or gradations of the composite are assembled.
The embo-limPnt~ of the invention described in Serial No. 08/046,438 also include an embodiment wl~leill the rate of fluid flowing from the di~el~illg means of the device is controlled by flow control means disposed intermlodi~t~ the l~sel voil outlet and the fluid di~ellsillg port of the device. More particularly, the flow rate control means comprises a fluid flow micro-conduit and a porous mPmher which functions to restrict the flow of fluid between the outlet and the dispellsi,lg port. The embo-l;"~ ; of the invention described herein include different forms of flow control means and also include novel flow i~lPrltifiç~ti~n means.
,30 WO 96/34651 PCT/US~ i017 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, l~ t~ construction.
More particularly, it is an object of the invention to provide such an apparatus and the method of m~kin~ the same, which can be used for the precise infusion of pharm~e--tir~l fluids to an ambulatory patient at controlled rates over extended periods of time.
It is another object of the invention to provide an apparatus of the aforementioned character which is highly reliable and easy-to-use by lay persons in a non-hospital environ-ment.
Another object of the invention is to provide an a~ald~us 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 pro-i<lc a low profile, fluid delivery device of l~min~e construction which can be m~nllf~c~ured ine~ell~ively in large volume by automated m~rllinPry Another object of the invention is to provide a device of the aforementioned character which includes a novel rate control ..~c..l~.dne disposed intermediate the fluid reservoir outlet and the outlet port of the devicc.
Another object of the invention is to providc a device of the character described which embodies a highly novel fluid flow in-~ic;~tor thal provides a readily discernible visual indication of fluid flow status through the dc-ricc.
Another object of the invention is to providc an appaldLus of the afo~ Lioned character in which the stored energy source is of a novel l~min~tP construction which can be precisely tailored to deliver fluid from the device at precise rates.
Another object of the invention is to provide a method of making a device of thecharacter described in the prece-lin~ paragraphs in which the elastomeric membrane is ple~LPsse(l and then cnnnPct~ to the base in a sealable manner.
Other objects of the invention are set forth in U. S. Patent No. 5,205,820 which is incorporated herein and still further objects will become more appalellL from the discussion which follows.
By way of s--mm~ry, the fluid delivery apparatus of the present form of the CA 022l9884 l997-l0-30 WO 96/34651 PCT/US~6/OGO17 invention colllplises three cooperating s~ba~semblies, namely a reservoir assembly, a fluid flow control s--b~c.sembly and a flow inrlic~tor s~b~cembly. The reservoir subassembly, which readily lends itself to automated m~mlf~rhlre, is generally similar to that described in copending Serial No. 08/046,438 and includes a base and a stored energy meansconl~lisillg at least one tlicten~l~ble elastomeric membrane which cooperates with the base to form a fluid l~sel~/oil. The fluid flow control sub~c~cmhly 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 inrlir~tor means of the invention colllplises a m~çh~nir~l fluid flow in~lir,~tQr 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 in~lir~ing the operating condition of the device are produced by the movement of thin, indicia-callyhlg films. These films, which cc,lll~lise a part of the flow in-lic~tor means, are shifted by the movement of mrçh~nir~l a~;~uatol~ which are deflected solely by the fluid pl'eS:~UlC within the device. The fluid flow in-lir~tor design does not invade the fluid flow path and yet utilizes the same stored energy means to generate fluid ~les~ e that provides for the normal functioning of the device. The fluid flow intlir~tor is highly reliable in operation, can be produced inexpensively, and, because it has very few parts, is easy to manufacture.
Brief Des~ ,lion of The D
Figure 1 is a generally pel~ye~;live top view of one form of the fluid delivery appaldLus of the invention.
Figure 2 is a generally p~l~L,ective, bottom view of the apparatus shown in Figure 1. , Figure 3A is a generally perspective, exploded view of the dowl~llealll portion of one form of the fluid di~cllshlg app~ldllls of the invention showing the flow in~lic~tor means and a portion of the flow control means.
CA 022l9884 l997-lO-30 WO 96/34651 PCT/US9G/0~017 Figure 3B is a generally perspective, exploded view of the remainder of the flowcontrol 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 illu~ Lillg its l~min~te construction.
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 ~el~e.;live, exploded view of one form of forward housing portionof the apl)dldtus 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 dL)~aldLus of the invention.
Figure 16 is a generally perspective, front view of the substrate portion of the rate control a~pd,alus.
Figure 17 is a generally perspective rear view of the substrate portion.
Figure 18 is a generally ~e-~l.e~ e view of the output port of the dl~pdldLUS.
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 d~)dldLUS.
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 CA 022l9884 l997-lO-30 WO 96/346Sl PCT/US~1G~0~017 of the invention.
Figure 24 is a cross-sectional view similar to Figure 14 showing the in~lic~tor means of the invention in its starting configuration.
Figure 25 is a fragmentary plan view of the symbol that is viewable by the user 5when the apparatus is in the configuration shown in Figure 24.
Figure 26 is a cross-sectional view similar to Figure 24 but showing the in~ic~tor 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 con~lguration shown in Figure 26.
10Figure 28 is a cross-sectional view similar to Figure 24, but showing the in~ tor means as it appears when there is a blockage duwllslll,alll of the in~ tor means that plevell~ 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.
15Figure 30 is a generally perspective, exploded view of one type of apparatus for carrying out the first step of one form of the method of the invention.
Figure 30A is a generally per~,e-;live view of another type of ap~alalu~ used inaccomplishing the method of the invention.
Figure 30B is a fragmentary, cross-sectional view of one of the membrane gripping 20elem~-ltc of the apparatus of Figure 30A.
Figure 31 is a cross-sectional view of the base portion of the device illu~ll dlhl~ the second step of one form of the method of the invention.
Figure 32 is a generally ~ el;live exploded view showing the next sequential steps of one form of the method of the invention.
25Figure 33 is a generally pel~e~;live exploded view of an apparatus for carrying out the first step of an alternate form of the method of the invention.
Figure 34 is a top plan diagr~mm~tic view of a portion of the appaldl~ls depicted generally in Figure 33 showing the tenter frame apparatus of the invention.
Figure 34A is an enlarged cross-sectional view taken along lines 34A-34A of Figure 3034 showing the membrane gripper means of the tenter frame apparatus.
Figure 35 is a generally ~els~e.;Liv-e, exploded view of yet another type of a~dldlus for call.yhlg out still another form of the method of the invention wherein an ela~lo,l,~,ic WO 96/34651 PCT/US~''CJ017 l~min~te is formed, which l~min~te provides the stored energy for expelling fluids from the device.
Des~ ioll of tlle Invention s 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 ;~lentifit-d generally by the numeral 30. As best seen in Figures 3A and 3B, the apparatus colllplises three major coo~eldlhlg s~b~srmblies namely, a reservoir subassembly, a flow rate control sllb~e~nhly, and a flow indicator subassembly. These s~ b~csemhlies will be ~ cl~se~1 in detail in the paragraphs which follow.
Considering first the reservoir s~h~csembly shown in Figure 3B, this sub~elnhly is similar in many respects to that described in Serial No. 08/046,438 and inrh-(lrs a base assembly 32, a stored energy source, or di~t~nfl~hle 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 en~ging element or protuberance 44 (see also Figure 5).
Rt:felling particularly to Figures 3B and 5, the ullage substrate 38 coll.~lises, in addition to the di~t~n~l~ble member eng;l~ing protuberance, or ullage, 44, filling means which enables filling of the fluid reservoir which is formed between protuberance 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 presellLly be described. Protuberance 44 is provided with a longit---lin~lly e~t~n~ling fluid passageway 52 (Figure 3B) which cc-.. -ic~trs with fluid passageways 54 and 56 provided in the base portion 38a of ullage substrate 38 (see also Figures S and 7).
Base portion 38a of ullage substrate 38 also inrl~ldes an ~-pst~n~ling 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 ullagesubstrate and the membrane capture housing are assembled in the ma~ el 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 WO 96/34651 PCT/US~ 017 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 subst~nti~lly tralls~aLent plastic material which is ~ il.,pel.. eable 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 m~n~lf~rture or in the field as may be desired.
Filling is accomplished by introducing fluid under l~lcs~uLe into inlet passageway 48 and thence into reservoir 46 via luer fitting 50. As the fluid under l,res~ulc flows into the reservoir, it will cause membrane assembly 34 to distend outwardly from protuberance 44 in the lllal~lel shown in Figure 5. Luer fitting 50 includes a skirt portion 50a, a valve seat 50b and a biasing spring 50c(see also Figure 22). Receivable into valve seat 50b is a ball check valve 68 which will lift from seat 50b against the 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 plc:jllcssed or un~l~cssed isotropic, elastomeric distendable membrane, it is here shown as a l~min~te assemblage made up of a plurality of initially generally planar tli.cten~l~ble el~m~ont~ or films. Referring particularly to Figure 3C, the stored energy means can be seen to COlll~l ise a l~min~Se assemblage made up of individual layers 34, 34a, 34b, 34c, and 34d.
Assemblage 34, which is typically ~re~llc~sed, filnrtion~ in much the same way as the distendable membranes described in Serial No. 08/046,438 and coupcldLcs 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 elasticcharacteristics of the stored energy means can be precisely tailored in the ",anllel described in Serial No. 08/046,438.
As previously ~ c~lsse~l, as the ~ teml~hle membrane assemblage 34 is ~ ten~
by the fluid p,c~u,c 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 , 30 protuberance 44, fluid within reservoir 46 will be uniformly and controllably forced outwardly through longitll~lin~lly extending passageway 52 in protuberance 44 and then into passageways 54 and 56 of portion 38a of ullage substrate 38.
WO 96/346Sl - PCT/U~, 'IOGO'17 For certain applications it is desirable to provide on one or more layers of themembrane assemblage a surface which is specifically designed to be compatible with the fluid to be delivered. For example, layer 34e can be provided on its underside with a compatibility layer 34f constructed from a co-polyester sold by DuPont under the name and S 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 i~i~n~ifi~od in the prece~iin~ paragraphs.
Turning next to a consideration of the flow rate control sub~c~çmhly of this latest form of the invention, this s~ba~semhly 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 co"~" ises 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 duw~ anl wall 72 of recess 68 is provided with fluid disl,ibuLion means co...~ g 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 rGr~l,ing to Figures 12 and 15, m~mher 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 in~lic~t~d in Figure 14, when member 76 is in place within cavity 68, the flow control membrane 66 is bonded at its cir~;ull-Ç~ ce to member 70 and is securely positioned between stand-offs 74 and 78 which cooperate to define a multiplicity of co~ e~.~. ic and 2~ radial e~ct~-n-ling fluid passageways, which function to direct fluid flow through the flow control means. Air within chamber 68 is vented via vent patch 92a and opening 92b (Figure 3B).
As shown in Figure 3D, flow control 66 here coll-~flses a l~min~tç construction made up of layers 66a, 66b, 66c, 66d, 66e, and 66f. More particularly, layer 66acoll,~ises first filter for initially filtering the fluid; while layer 66b c~.-.p-ises 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 ~lrst rate. Layer 66e is a CA 022l9884 l997-lO-30 WO 96/34651 PCT/US~)G/0'017 second flow rate control membrane for controlling flow at a second rate. Disposed intermP~ tç 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 Gelman Sciences under the name and style of SUPOR.
Flow rate control layers 66c and 66e can be CO~ d 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 th~t the surface and orifice rh~mi~try of each layer of the flow control 66 be rendered hydrophillic.
As best seen in Figures 3B and 15, ~ ..h~r 76 includes a dowllw~ldly ç~ctf-nrling fluid inlet leg or segment 80 which is provided with a fluid passageway 82. Passageway 82 is adapted to co.~.. ic~te with chamber 68 whcn 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 segm.o-nt 80.
Formed on either side of recess 84 are wing-like protubelallces 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 sockel 90 (Figure 7) which closely receives a tubular extension 92 formed as a part of inlet s~gm~nt 80 (Figure 14). Locatedproximate the upper edge of :jul,~oll sllu-,lulc 70 are spaced-apart capture grooves 96, which attach cover 36 to member 70.
As shown in Figure 5, when the flow control sub~emhly is mated with the reservoir assembly, fluid inlet passageway 82 of member 76 is placed in fluid commllnir~tion with reservoir 46 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 ~res~u~e flows into the u~t~calll portion of chamber 68 behind lllelll~ldlle 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 s~b~sçmhly. As best seen in Figures 12 and 18, the outlet port con~ ises an assembly 87 which is receivable in a cavity 73 formed in the back of d~w~ edlll wall 70a of substrate 70. Assembly 87 inrlu~les a fluid outlet 90 and an internal chamber 92, the purpose of which will presently be described. A flexible strain relief tube 91 is sealably receivable over the extremity of assembly 87 (Figure 10) and a centrally disposed microbore delivery tube 91a is telescopically received int~rn~lly of the extremity in the n~dll,lel shown in Figure 10. During filling of chamber 92, air therewithin can be vented to atmosphere via vent patch 92a.
The flow control means can also co,lll"ise an assemblage of a plurality of layers of permeable materials, P-1, P-2, and P-3 of the character seen in Figure 31 of U. S. Patent ' 10 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 ple~ule 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 in~lic~tcr 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 in~lir~tor means here co~ ,lises an in~ tor base or platform 100, a support or lens plate 102, and a hollow housing 104 within which the platform and the :iu~oll plate are mounted. As seen in Figure 12, plate 102 has a viewing lens 102a which indexes with an ape~llul~ 104a provided in housing 104.
Disposed betw~ell platform 100 and plate 102 are first and second indicia-carrying means shown here as thin films. These films identifi~l here as 106 and 108, are in i.. ~ contact and are coll~llu~;led from a s~-bst~nti~lly lldllspalelll, flexible polymer material such as mylar. The indicia-carrying means need not be thin films, but rather can be any type of surface plese~.li..g member upon which indicia can be provided. The dOwl~ll~alll 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 (Flgure 27), and a red X 107c (Figure 29), each con~i~ting 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 WO 96/34651 PCT/US~ 'nC017 printed with a pattern of diagonal alternating clear and opaque strips 108a that occur in a 1:2 ratio. The printed ratio of the supe~ior "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 ~tt~rhmPnt 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 m~int~inPd 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 Lldl-svc~e displ~r~pmpn~ of the patterns illlplhllcd thereon.
Referring particularly to Figures 3A, 9 and 14, it can be seen that support plate 102 is provided with transversely spaced, ch~nnPl-like depressions 120 and 122 which index with slots 114 and 116 res~ec~ively when the components are assembled in the manner shown in Figures 9 and 14. Aligned with the u~sllca~ll side of slots 114 and 116 are mPch~nir~l actuator means, here provided as mPch~nir~l ac~uato,~ or elastomeric element~
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 ll,am1el plcscl1tly to be described, the mPch~ni~l actuator means are deflected from their initial configuration whenever there is sufficient fluid plc:j~ulc present within the fluid flow path to cause their outward deflection toward thin films 106 and 108. During operation the first mPrh~nir~l actuator elemPnt 124 is deflected by fluid ~les~ulc of reservoir 46. More particularly, when there is sufficient fluid ~c~u,c in the fluid reservoir and fluid is being delivered by the stored energy means of the device, the first niPch~nir~l actuator means is deflected ~u~wa,-dly so as to urge the non-patterned portion 109 of in-lir~tor film 108 into expansion ch~nnPI 122. As the film arches into rh~nn~l 122, the printed portion of the film is transversely displaced a specific ~ t~nre. This film displ~ren Pnt 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 102a (see Figures 1, 26 and 27).
CA 022l9884 l997-lO-30 WO 96/34651 PCT/US~16/~lC017 As can be observed by referring to Figures 28 and 29, both the first and second mechanical elastomeric actuator elements 124 and 126 are infl~t~rl and deflected outwardly toward their respective extension ch~nn~ 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 S caused by blockage of the delivery line do~hl~llta"l from second mrc.h~ni-~l actuator element 126. While element 124 can be deflected by normal line pl~s~ule, element 126 is deflected only by ~le~:~ule buildup res~ in~ from the dowll~tle~lll blockage. When both m.of~h~nic~l actuators are deflected outwardly, bolh 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 apt:llule of the support plate (see Figures 28 and 29).
A third ~lignmPnt of symbol patterns as shown in Figures 24 and 25 is visible when the device is in an unfilled state or when the delivcry line is open, the reservoir is empty and fluid delivery to the patient has been completcd. In this case, there is no fluid ples~ule in the line on either the u~Ll~,alll or d~wll~lr~alll side of the flow control means and thus both the first and second mechanical ~c tn~tor elc.. b~ l~t~ are in a non-deflected position. In this condition, the inferior and superior films arc not transversely displaced and thus exhibit a third combination of patterns rçsl~lting in a third symbol as, for example, a circle being visible through the viewing apelluie of the support plate (see Figure 25). .~t~l~ting elements 124 and 126 can be precisely tailored to dctlect under various plCS~UICs thereby permitting great apparatus versatility.
' In considering the method of operation of thc device and the "lamlel in which fluid flows through the device, lc;Çelellce should be ma~le particularly to Figures 5, 10, and 12.
During the filling step, the fluid to be di~Jenscd is introduced into reservoir 46 via a fluid inlet conduit 49a (Figure 1) which is Connf~ct~d ~o luer fitting 50. Fluid flowing into the fitting lifts check valve ball 68 against the urging of spring 50c and causes the distendable nlelllb~ e 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 at-mosphere 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 fluid 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 toreturn toward a less distended configuration causing fluid within the reservoir to flow CA 022l9884 l997-lO-30 WO 96/34651 PCT/US9"~,C017 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 fluid entering chamber 68 of member 70 from passageway 82 and u~L~ l of membrane 66 can by pass flow rate control mernher 66 and flow directly toward an ear-shaped extension 76a provided on ~ member 76 via flow passageways 76b and 76c. From passageway 76c, the fluid will flow under ~les~ e 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 protubc;l~nce 71 formed on end wal1 70c of substrate 70. This co~ luction permits the fluid flowing into ear-shaped protuberance 76a to flow through passageway 70a and impinge directly upon flow in-lir~tor element 124 which sealably engages the protuberance, c<...~ g it to deform outwardly in a manner to force portion 109 of inflir~tor film 108 to arch into expansion channel 122 (Figure 26). This, in turn, will cause Llan~v~l~e displ~t~emPnt of in-lir~tor film 108 in the manner previously described.
As inrlir~t.ocl in Figure 28, fluid flowing through passageway 82 of disc-shapedmember 76 will also be distributed over the upstream face of the rate control membrane 66 by the fluid di~l. ibulion 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 92 of outlet port assembly 87. The fluid will then flow outwardly of the device through fluid outlet 90 to which an infusion line 93 is connPct~l (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 l~les~ul~, F-2 will impinge upon in-lir~tor element 126 c~ in~ it to deflect outwardly in the manner shown in Figure 28. This outward deflection of element 126 will urge a portion of in~lir~tor film 106 into receiving channel 126 of the lens plate c~ ing Llall~v~lse movement of film 106 so as to reposition film 106 relative to film 108. Should fluid flow into chamber 92 cease, in-lir~tor 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 Llleleby once again c~nsing the "O" symbol to be viewable through the viewing WO 96/34651 PCT/US~ 60~17 lens.
The method of the invention for constructing a fluid delivery device of the character described in the prece~ling paragraphs will now be described. Refcl,h~g to Figure 30, one type of apparatus for accomplishing the first step of one form of the method of the S invention is there dia~ ir~11y illustrated. This initial step of the method co~ ,lises .cimnlt~n~ous stretching the elastomeric membrane subst~nti~lly ullirollllly7 dirrc~cllLially~
uniaxially, or biaxially using a stretching means of the general chala~;Lcr shown in Figure 30. This membrane stretching means here colll~ es a stretching, or elongation fixture 150 which functions to controllably stretch the elastomeric membrane 34 in the mallllcl shown in Figure 30. SLlcLcllillg fixture 150 includes four ciL~;u~llrclellLially spaced membrane gripping assemblies 154, each having gripping elem~nt~ 156 for ~,lip~ g the edges of the elastomeric, isotropic membrane 34. Each of the gripping assemblies 154 is affixed to a slide block 158 which is slidably movable along a pair of tracks 160 by means of a screw assembly 162 which is carried by an end plate 160a provided on tracks 160. Each screw assembly 162 colllplises a threaded rod 162a, one end of which is connloctr~l to a slide block 158. As the threaded rod is rotated by means of a handle 162b, the slide block, along with its associated gripping elem~nt 156, will move outwardly relative to the center of membrane 34 causing it to extend OuLwal-lly. A manual vernier 166 is provided on each screw assembly for in~lir~ting the extent of movement of the slide block relative to the membrane.
Turning to Figure 30A, another type of apparatus usable in callyill~, out the method of the invention is there illustrated. This apparatus also includes a membrane stretching fixture 167 which functions to controllably radially stretch the elastomeric membrane 34 in the manner illustrated in Figure 30a. SLIc~ lg fixture 167 inrl~lflrs a plurality of circumrclclllially spaced mPrh~nir~lly ~rt~ tr~l membrane ~,lippillg assemblies 171, each having gripping çl(~ 171a (Figure 30B) for gripping the edges of the isotropic membrane. Each of the gripping assemblies 171 is mounted on a support table "T", which also ~uL,polL~ the mPch~nic~l equipment for operating assemblies 171. This type of e~luil,mcllL is of a character well known to those skilled in the art. As the gripping assemblies are ~ct~ cl, the gripping elemrntc wiil move radially ouLwdldly relative to the center of membrane 34 causing it to extend outwardly a predetermined amount.
Also forming a part of the apparatus of Figure 30A is a centrally disposed sonic CA 022l9884 l997-lO-30 WO 96/34651 PCT/US9~'0~017 welding apparatus 173, the purpose of which will ~l~selllly be described. Surrounding the sonic welder are vacuum operated article pick-up devices 174a, 174b, and 174c which can be used to position the cover portion of the fluid delivery devices relative to the membrane during the assembly operation. Each of these pick-up devices includes a gripping member 174d which is rotatable about a support shaft 174e.
Referring next to Figure 31, following l,re~liessillg of membrane 34, using either -the fixture shown in Figure 30 or the fixture shown in Figure 30A, the next step in the method of the invention col.lplises affixing the ~le~ ;ssed membrane 34 to the periphery of the base portion 38a of ullage substrate 38. This is accomplished by moving capture housing 40 dOwllwaldly relative to base portion 38a in a ,l.amler such that ~ ,ssed membrane 34 will be securely clamped between the peripheral portions of base 38a and the peripheral portion of capture housing 40. As the capture hoùsing is moved toward the base, which is typically ~.lppolled beneath membrane 34, the membrane will engage and conform to the ullage defining means or protuberance 44 in the mdmler illustrated in Figure 31 (see also Figure 3B).
As previously ~li.ccllcc-ed herein, capture hullsing 40, as well as membrane 34, can be illtelco.~.-P~ A with base portion 38a in any suitable l,.allllel- well known to those skilled in the art, such as adhesive or sonic bonding. In the embodiment of the invention shown in Figures 30 and 31, base portion 38a is provided with a capture groove 59 and an ~ ?lçent tongue 60. Capture housing 40, on the other hand, is provided with a capture tongue 61 and a groove 62 which closely receives tongue 60 as the capture housing moves into engagement with base portion 38a in the manner shown in Figures 5, 6, and 31.
Base portion 38a is also provided with an l-pst~n-iing membrane cutting means orprotuberance 155 which cil~;u.l.iclibes tongue 60 and functions to cleanly cut membrane 34 upon capture housing 40 eng~ing base portion 38a. Protube-dllce 155 also uniquely functions as an energy director for sonic weldment of housing 40 to base 38a.
Sim~ nPously with the cutting of the membrane, the capture hollsing can be sonically welded to the base portion in the proximity of protube~dllce 155 through use of a sonic welder 173 (Figure 30A) by techniques well understood by those skilled in the art. After the sonic welding step, the capture plate and membrane are securely, sealably ~ ,rco..~-Pcted with the base portion. Manipulation of the capture housing can be accolllplished using the pick-up devices shown in Figure 30A when this type of fixture is CA 022l9884 l997-lO-30 WO 96/34651 PCTIUS9~'0li017 used.
Turning now to Figure 32, the next sequential steps in the practice of the method of the invention are there illustrated. More particularly, after hlLelcom1ection of the membrane and the housing with base portion 38a to form a base assembly 175, cover 36 S is connPcterl to base assembly 175 to form a fluid delivery reservoir assembly 177 of the character depicted in Figure 32. Cover 36 can be interconn.oct.orl with base assembly 175 by any suitable means such as adhesive bonding or sonic welding.
The next step in the present form of the method of the invention is to connect :~u~po,L structure 70 of the rate control assembly of the invention with fluid delivery reservoir assembly 177. This step is accomplished in the manner previously described herein by inselLi"g wings 86 of support 70 into the wing-receiving ape,Lu,~s 88 formed in base portion 38a. Following insertion of wings 86 into apertures or sockets 88 (Figure 7), wings 86 are secured in place by any suitable bonding means such as adhesive bonding or sonic welding to form the controlled fluid delivery subassembly 179 (Figure 32).This done, the final step in this form of the method of the invention cv.l~,isesi"Lt;,.;o~ octing hou~ing 104 of the in~ tor assembly 181 with the control delivery assembly 179.
Turning now to Figure 33, another novel form of the method of the present inventionistheredia~,a....~.Atir~llyillustrated. Inaccordancewiththiscontinuousassembly type m.-.tho-l of the invention, the el~tomPric membrane, which is to be hllelco~ cle~l with base 38a, col"~.ises a length of ela~l~J"le.ic membrane 34a that is controllably removed from a first roll 183. Roll 183 colllplises a long length of ela~oll.~lic membrane material that has been wound upon a spindle 185 which is suitably mounted for rotation about its Lld~ e axis so that the membrane material can be controllably unrolled thelerlolll.
After a length of elastomeric membrane is removed from roll 183, it is hlLtlco~ l with a series of longitll-lin~lly spaced clamps or ~ li~e.~ 187 (Figures 34 and 34A) which co",prise a part of a ~imlllt~n~ous biaxial stretching means which is used to controllably ~ e~s the membrane. The biaxial stretching means can take several forms, but preferably co"~p,ises a tenter apparatus 188 of the general character illustrated in Figure 34. While a number of different types of tenter ~ppdldLus have been suggested in the past and their design and operation is well known to those skilled in the art, a tenter apparatus of the general character described in German patent 1,504,479 issued to Erwin CA 022l9884 l997-lO-30 WO 96/34651 PCT/US~5. ~a'017 Kampf can be used in modified form to accomplish the biaxial ~Iretc;llh~g step of the inventlon.
As best seen in Figure 34, as the membrane is unrolled from roll 183, it is introduced into the tenter apparatus 188 in a ,l,ani~er such that the edges of the membrane S are ~ipped by gripping clamps 187. These gripping clamps are, in turn, operably associated with elongated endless chain assemblies "C" and with guide rails "R" (Figures 34 and 34A), so that as the chains move about rotating sprockets "S" and dirrG,G"Lial screws "DS", the clamps diverge so as to controllably impart biaxial stretching forces to the membrane c~sinp~ it to be stretched in the manner illustrated in Figures 33 and 34.
Stretching is accomplished simnlt~nrously in the m~(~hinr direction oriGllL~lion (MDO) and in the transverse direction orientation (TDO). It is to be understood that the ~GIchillg ratios can be precisely tailored to each axis to provide the desired initial strain energy density and extension pattern of the ~1ictenrl~hle membrane. Under certain ci~ es, the extension values for the MDO axis may be different than the ext~-n~i-)n values for the TDO axis. It is to be appreci~t~cl, however, that in the same i~ res, no ~lG~ tch of the membrane will be desired and the tenter frame apparatus will not be used.
After the di~tçn~l~ble membrane has been applol,liately stretched to produce a prestressed membrane 34a of the desired biaxial ~1imrn~ion (Figure 33), it is positioned over the upper surface of base portion 38a. This done, capture housing 40 is placed over membrane 34a and base portion 38a in a l"a,."el- to urge a peripheral portion of the p-G~ c~sed membrane into engagement with base 38a. Next, the ~ ,L.essed membraneis cut and then, along with capture housing 40, is affixed to base 38a by any suitable bonding tçrhni~le such as m~rh~nir~l or adhesive bonding or sonic welding. Following the cutting step the rçm~ining e~ o...~lic membrane material is wound about a take-up drum 190 in the Illalll,el shown in Figure 33 for later salvage. It is to be understood that the ~,G~L,essed membrane can be of considerable width so that a plurality of side-by-side housings 40 can be placed over the membrane siml-1t~nrously and the membrane can then be cut at a plurality of side-by-side locations. The housings and the cut membranes can then be sim~lt~nrously joined with a plurality of bases 38a disposed in a side-by-side relationship bellc~lLh the membrane.
After membrane 34a and capture housing 40 have been affixed to base 38a to form base assembly 175 (Figure 32), the next sequential steps in the device assembly are CA 022l9884 l997-lO-30 WO 96/34651 PCT/US9G/C~017 accomplished in the manner illustrated in Figure 32 and as previously described herein in connection with the earlier described method of the invention.
Referring finally to Figure 35, yet another novel form of the method of the present invention is there diagr~mm~ti~ ~lly illustrated. In accordance with this continuous assembly type method of the invention, the stored energy source, which is to be interconnPcted with the base 38a, com~lises a length of ela~loll.elic l~min~te 34b that is formed by controllably removing lengths of membrane material from three rolls of material. These rolls,~esign~te(l as 200, 202, and 204, each c-,lll~lise a long length of elastomeric membrane material that has been wound upon a spindle which is suitably mounted for rotation about its transverse axis so that the membrane material can be controllably unrolled from each of the rolls.
After a length of elastomeric membrane is removed from each of the rolls 200, 202, and 204, the lengths are brought into contact to form a l~min~te construction 34b. This l~min~te co~ u~lion is then h~lel~o....~octed with a series of lon~ih--lin~lly spaced clamps 187 (Figure 34) which co."pli~e a part of the previously described biaxial stretching means which is used to controllably pl~l,ess the membrane. As before, the biaxial ~Llelchillg means can take several forms, but preferably c~lllplises a tenter appdldlus 188 of the general character illustrated in Figure 34.
As the membrane l~min~te 34b is formed in the lllal,l,er shown in Figure 35, it is introduced into the tenter apparatus 188 so that the edges of the l~ tr are gripped by gripping clamps 187. As shown in Figure 34, these gripping clamps are, in turn, associated with elongated endless chain assemblies "C" and guide rails "R" so that as the chains move about rotating sprockets "S", and dirrtl~.,lial screws "DS", the clamps diverge so as to controllably impart biaxial stretching forces on the l~min~te c~sin~ it to be controllably biaxially stretched.
After the ~ ten-l~ble elastomeric membrane l~min~te has been apploL,lidtely stretched to produce the ple~l,essed l~min~te 34b the l~min~t~ is po.~ition~ over the upper surface of base portion 38a. This done, capture housing 40 is placed over the l~min~te and base portion 38a in a nldlmel to urge a peripheral portion of the l~min~t~ into engagement with base 38a. Next the l~min:~te is cut and then, along with capture housing 40, is affixed to base 38a in the ,l,aml~l previously described. Following the cutting step, the rem~ining elastomeric membrane l~min~t~ material is wound about a take-up drum 190 for later WO 96/34651 PCT/U~ '0~017 salvage.
After l~min~t~ 34b and capture housing 40 have been affixed to base 38a to form base reservoir assembly 175 (Figure 32), the next sequential steps in the device assembly are accomplished in the manner illustrated in Figure 32 and as previously described herein 5in comleclion with the earlier described embodiment of the invention.
- 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 m~king changes and modifications in the individual parts or their relativc assembly in order to meet specific requi,~l.le.l~s or conditions. Such changes and modifications may be made without 10departing from the scope and spirit of the invention, as set forth in the following claims.
SPECIFICATION
Background of The Invention This is a Continn~tion-In-part Application of a co-pending Application filed May1, 1995 which is a Co..l;....,.lion-In-Part of co-pending application, Serial No. 08/046,438, filed May 18, 1993; which is a Con~in--~tion-In-Part of Application Serial No. 07/987,021 which has now issued into Patent No. 5,279,558; which is a Co..~ tion-In-Part of Application 07/870,269 which has now issued into Patent No. 5,205,820; and which is, in turn, a Contin-~tion-In-Part of Application Serial No. 07/642,208 which has now issued into U.S. Patent No. 5,169,389; which is a Contin--~tion-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 conce~ an improved apparatus, inrhl-lin~ visual flow inflir~tor means, for infusing medicinal agents into an ambulatory patient at specific rates over extended periods of time.
Des~ lion of the Prior Art Many medicinal agents require an intravenous route for ".l.~ l. ation 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 col~ce-lLldtions has also increased the need for accuracy in controlling the delivery of such drugs. The delivery device, while not an active ph~rm:lrologic agent, may enh~nre the activity of the drug by m~ ting its therapeutic effectiveness. Certain classes of new ph~rm~rologic agents possess a very narrow range of theld~utic effectiveness, for in~t~nre, too small a WO 96/346Sl PCT/US96/06047 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 ~imini~tration sets and the familiar bottle suspended above the patient. Such methods are cumbersome, imprecise and require bed confinPment of the patient. Periodic moni~o,ing of the apparatus by the nurse or doctor is required to detect malfunctions of the infusion dpl)dl~lLUS.
Devices from which liquid is expelled from a relatively thick-walled bladder by internal stresses within the ~ t~n~efl 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 ~lifflrnlt and e~ell~ive to m~ r~. l---e and use. Further, the devices are somewhat unreliable and their fluid discharge rates are frequently h.lpiecise.
The apparatus of the present invention overcomes many of the drawbacks of the prior art by elimin~ting the bladder and making use of l~ct;nLly 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 clasL~llleric film membrane controllably forces fluid within the clldmber into fluid flow cll~nn~-ls provided in the base.
The el~lol..~lic film materials used in the dpparatus of the present invention, as well as various alternate constructions of the apl)dld~us, are described in detail in U. S.
Patent No. 5,205,820 issued to the present inventor. Theler{,l~" U.S. Patent No.5,205,820 is hereby incorporated by r~relellce in its ellLil~Ly 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 embo-limPnt~ of the invention. This co-pending application is also hereby incorporated by lefelellce in its ~Illilely as though fully set forth herein.
The apparatus of the present invention can be used with minim~l professional e in an alternate health care environrnent, such as the home. By way of example?devices of the invention can be comfortably and conveniently removably affixed to the CA 022l9884 l997-lO-30 WO 96/346Sl PCTIU33~ ~0'017 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 t precisely the correct qll~ntitiçs and at extended microfusion rates over time.
One of the embodiments of the invention described in Contin-l~tion-In-Part ~ application Serial No. 08/046,438 includes a highly novel, l~min~ stored energy means made up of a plurality of individual membranes. As before, this unique stored energy means cool,er~tes with the base to define one or more fluid leselvoil~ or chambers.
However, by constructing the stored energy means from a composite of several elements or layers, the elastic chalactelislics 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 sim--lt~nPously precluding any negative migration of selpcte~l atmospheric gases or vapors into the reservoir. Where the composite is made up of two or more layers of alte~ g thi- l~nPss and permeability, and the permeability con~L~ of the individual film layers are pressure depPn~1Pnt, the permeability of the stored energy means is effected and the direction of flow of the permeant through the membrane wall is controlled by the order in which the individual layers or gradations of the composite are assembled.
The embo-limPnt~ of the invention described in Serial No. 08/046,438 also include an embodiment wl~leill the rate of fluid flowing from the di~el~illg means of the device is controlled by flow control means disposed intermlodi~t~ the l~sel voil outlet and the fluid di~ellsillg port of the device. More particularly, the flow rate control means comprises a fluid flow micro-conduit and a porous mPmher which functions to restrict the flow of fluid between the outlet and the dispellsi,lg port. The embo-l;"~ ; of the invention described herein include different forms of flow control means and also include novel flow i~lPrltifiç~ti~n means.
,30 WO 96/34651 PCT/US~ i017 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, l~ t~ construction.
More particularly, it is an object of the invention to provide such an apparatus and the method of m~kin~ the same, which can be used for the precise infusion of pharm~e--tir~l fluids to an ambulatory patient at controlled rates over extended periods of time.
It is another object of the invention to provide an apparatus of the aforementioned character which is highly reliable and easy-to-use by lay persons in a non-hospital environ-ment.
Another object of the invention is to provide an a~ald~us 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 pro-i<lc a low profile, fluid delivery device of l~min~e construction which can be m~nllf~c~ured ine~ell~ively in large volume by automated m~rllinPry Another object of the invention is to provide a device of the aforementioned character which includes a novel rate control ..~c..l~.dne disposed intermediate the fluid reservoir outlet and the outlet port of the devicc.
Another object of the invention is to providc a device of the character described which embodies a highly novel fluid flow in-~ic;~tor thal provides a readily discernible visual indication of fluid flow status through the dc-ricc.
Another object of the invention is to providc an appaldLus of the afo~ Lioned character in which the stored energy source is of a novel l~min~tP construction which can be precisely tailored to deliver fluid from the device at precise rates.
Another object of the invention is to provide a method of making a device of thecharacter described in the prece-lin~ paragraphs in which the elastomeric membrane is ple~LPsse(l and then cnnnPct~ to the base in a sealable manner.
Other objects of the invention are set forth in U. S. Patent No. 5,205,820 which is incorporated herein and still further objects will become more appalellL from the discussion which follows.
By way of s--mm~ry, the fluid delivery apparatus of the present form of the CA 022l9884 l997-l0-30 WO 96/34651 PCT/US~6/OGO17 invention colllplises three cooperating s~ba~semblies, namely a reservoir assembly, a fluid flow control s--b~c.sembly and a flow inrlic~tor s~b~cembly. The reservoir subassembly, which readily lends itself to automated m~mlf~rhlre, is generally similar to that described in copending Serial No. 08/046,438 and includes a base and a stored energy meansconl~lisillg at least one tlicten~l~ble elastomeric membrane which cooperates with the base to form a fluid l~sel~/oil. The fluid flow control sub~c~cmhly 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 inrlir~tor means of the invention colllplises a m~çh~nir~l fluid flow in~lir,~tQr 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 in~lir~ing the operating condition of the device are produced by the movement of thin, indicia-callyhlg films. These films, which cc,lll~lise a part of the flow in-lic~tor means, are shifted by the movement of mrçh~nir~l a~;~uatol~ which are deflected solely by the fluid pl'eS:~UlC within the device. The fluid flow in-lir~tor design does not invade the fluid flow path and yet utilizes the same stored energy means to generate fluid ~les~ e that provides for the normal functioning of the device. The fluid flow intlir~tor is highly reliable in operation, can be produced inexpensively, and, because it has very few parts, is easy to manufacture.
Brief Des~ ,lion of The D
Figure 1 is a generally pel~ye~;live top view of one form of the fluid delivery appaldLus of the invention.
Figure 2 is a generally p~l~L,ective, bottom view of the apparatus shown in Figure 1. , Figure 3A is a generally perspective, exploded view of the dowl~llealll portion of one form of the fluid di~cllshlg app~ldllls of the invention showing the flow in~lic~tor means and a portion of the flow control means.
CA 022l9884 l997-lO-30 WO 96/34651 PCT/US9G/0~017 Figure 3B is a generally perspective, exploded view of the remainder of the flowcontrol 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 illu~ Lillg its l~min~te construction.
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 ~el~e.;live, exploded view of one form of forward housing portionof the apl)dldtus 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 dL)~aldLus of the invention.
Figure 16 is a generally perspective, front view of the substrate portion of the rate control a~pd,alus.
Figure 17 is a generally perspective rear view of the substrate portion.
Figure 18 is a generally ~e-~l.e~ e view of the output port of the dl~pdldLUS.
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 d~)dldLUS.
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 CA 022l9884 l997-lO-30 WO 96/346Sl PCT/US~1G~0~017 of the invention.
Figure 24 is a cross-sectional view similar to Figure 14 showing the in~lic~tor means of the invention in its starting configuration.
Figure 25 is a fragmentary plan view of the symbol that is viewable by the user 5when the apparatus is in the configuration shown in Figure 24.
Figure 26 is a cross-sectional view similar to Figure 24 but showing the in~ic~tor 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 con~lguration shown in Figure 26.
10Figure 28 is a cross-sectional view similar to Figure 24, but showing the in~ tor means as it appears when there is a blockage duwllslll,alll of the in~ tor means that plevell~ 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.
15Figure 30 is a generally perspective, exploded view of one type of apparatus for carrying out the first step of one form of the method of the invention.
Figure 30A is a generally per~,e-;live view of another type of ap~alalu~ used inaccomplishing the method of the invention.
Figure 30B is a fragmentary, cross-sectional view of one of the membrane gripping 20elem~-ltc of the apparatus of Figure 30A.
Figure 31 is a cross-sectional view of the base portion of the device illu~ll dlhl~ the second step of one form of the method of the invention.
Figure 32 is a generally ~ el;live exploded view showing the next sequential steps of one form of the method of the invention.
25Figure 33 is a generally pel~e~;live exploded view of an apparatus for carrying out the first step of an alternate form of the method of the invention.
Figure 34 is a top plan diagr~mm~tic view of a portion of the appaldl~ls depicted generally in Figure 33 showing the tenter frame apparatus of the invention.
Figure 34A is an enlarged cross-sectional view taken along lines 34A-34A of Figure 3034 showing the membrane gripper means of the tenter frame apparatus.
Figure 35 is a generally ~els~e.;Liv-e, exploded view of yet another type of a~dldlus for call.yhlg out still another form of the method of the invention wherein an ela~lo,l,~,ic WO 96/34651 PCT/US~''CJ017 l~min~te is formed, which l~min~te provides the stored energy for expelling fluids from the device.
Des~ ioll of tlle Invention s 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 ;~lentifit-d generally by the numeral 30. As best seen in Figures 3A and 3B, the apparatus colllplises three major coo~eldlhlg s~b~srmblies namely, a reservoir subassembly, a flow rate control sllb~e~nhly, and a flow indicator subassembly. These s~ b~csemhlies will be ~ cl~se~1 in detail in the paragraphs which follow.
Considering first the reservoir s~h~csembly shown in Figure 3B, this sub~elnhly is similar in many respects to that described in Serial No. 08/046,438 and inrh-(lrs a base assembly 32, a stored energy source, or di~t~nfl~hle 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 en~ging element or protuberance 44 (see also Figure 5).
Rt:felling particularly to Figures 3B and 5, the ullage substrate 38 coll.~lises, in addition to the di~t~n~l~ble member eng;l~ing protuberance, or ullage, 44, filling means which enables filling of the fluid reservoir which is formed between protuberance 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 presellLly be described. Protuberance 44 is provided with a longit---lin~lly e~t~n~ling fluid passageway 52 (Figure 3B) which cc-.. -ic~trs with fluid passageways 54 and 56 provided in the base portion 38a of ullage substrate 38 (see also Figures S and 7).
Base portion 38a of ullage substrate 38 also inrl~ldes an ~-pst~n~ling 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 ullagesubstrate and the membrane capture housing are assembled in the ma~ el 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 WO 96/34651 PCT/US~ 017 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 subst~nti~lly tralls~aLent plastic material which is ~ il.,pel.. eable 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 m~n~lf~rture or in the field as may be desired.
Filling is accomplished by introducing fluid under l~lcs~uLe into inlet passageway 48 and thence into reservoir 46 via luer fitting 50. As the fluid under l,res~ulc flows into the reservoir, it will cause membrane assembly 34 to distend outwardly from protuberance 44 in the lllal~lel shown in Figure 5. Luer fitting 50 includes a skirt portion 50a, a valve seat 50b and a biasing spring 50c(see also Figure 22). Receivable into valve seat 50b is a ball check valve 68 which will lift from seat 50b against the 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 plc:jllcssed or un~l~cssed isotropic, elastomeric distendable membrane, it is here shown as a l~min~te assemblage made up of a plurality of initially generally planar tli.cten~l~ble el~m~ont~ or films. Referring particularly to Figure 3C, the stored energy means can be seen to COlll~l ise a l~min~Se assemblage made up of individual layers 34, 34a, 34b, 34c, and 34d.
Assemblage 34, which is typically ~re~llc~sed, filnrtion~ in much the same way as the distendable membranes described in Serial No. 08/046,438 and coupcldLcs 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 elasticcharacteristics of the stored energy means can be precisely tailored in the ",anllel described in Serial No. 08/046,438.
As previously ~ c~lsse~l, as the ~ teml~hle membrane assemblage 34 is ~ ten~
by the fluid p,c~u,c 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 , 30 protuberance 44, fluid within reservoir 46 will be uniformly and controllably forced outwardly through longitll~lin~lly extending passageway 52 in protuberance 44 and then into passageways 54 and 56 of portion 38a of ullage substrate 38.
WO 96/346Sl - PCT/U~, 'IOGO'17 For certain applications it is desirable to provide on one or more layers of themembrane assemblage a surface which is specifically designed to be compatible with the fluid to be delivered. For example, layer 34e can be provided on its underside with a compatibility layer 34f constructed from a co-polyester sold by DuPont under the name and S 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 i~i~n~ifi~od in the prece~iin~ paragraphs.
Turning next to a consideration of the flow rate control sub~c~çmhly of this latest form of the invention, this s~ba~semhly 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 co"~" ises 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 duw~ anl wall 72 of recess 68 is provided with fluid disl,ibuLion means co...~ g 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 rGr~l,ing to Figures 12 and 15, m~mher 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 in~lic~t~d in Figure 14, when member 76 is in place within cavity 68, the flow control membrane 66 is bonded at its cir~;ull-Ç~ ce to member 70 and is securely positioned between stand-offs 74 and 78 which cooperate to define a multiplicity of co~ e~.~. ic and 2~ radial e~ct~-n-ling fluid passageways, which function to direct fluid flow through the flow control means. Air within chamber 68 is vented via vent patch 92a and opening 92b (Figure 3B).
As shown in Figure 3D, flow control 66 here coll-~flses a l~min~tç construction made up of layers 66a, 66b, 66c, 66d, 66e, and 66f. More particularly, layer 66acoll,~ises first filter for initially filtering the fluid; while layer 66b c~.-.p-ises 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 ~lrst rate. Layer 66e is a CA 022l9884 l997-lO-30 WO 96/34651 PCT/US~)G/0'017 second flow rate control membrane for controlling flow at a second rate. Disposed intermP~ tç 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 Gelman Sciences under the name and style of SUPOR.
Flow rate control layers 66c and 66e can be CO~ d 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 th~t the surface and orifice rh~mi~try of each layer of the flow control 66 be rendered hydrophillic.
As best seen in Figures 3B and 15, ~ ..h~r 76 includes a dowllw~ldly ç~ctf-nrling fluid inlet leg or segment 80 which is provided with a fluid passageway 82. Passageway 82 is adapted to co.~.. ic~te with chamber 68 whcn 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 segm.o-nt 80.
Formed on either side of recess 84 are wing-like protubelallces 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 sockel 90 (Figure 7) which closely receives a tubular extension 92 formed as a part of inlet s~gm~nt 80 (Figure 14). Locatedproximate the upper edge of :jul,~oll sllu-,lulc 70 are spaced-apart capture grooves 96, which attach cover 36 to member 70.
As shown in Figure 5, when the flow control sub~emhly is mated with the reservoir assembly, fluid inlet passageway 82 of member 76 is placed in fluid commllnir~tion with reservoir 46 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 ~res~u~e flows into the u~t~calll portion of chamber 68 behind lllelll~ldlle 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 s~b~sçmhly. As best seen in Figures 12 and 18, the outlet port con~ ises an assembly 87 which is receivable in a cavity 73 formed in the back of d~w~ edlll wall 70a of substrate 70. Assembly 87 inrlu~les a fluid outlet 90 and an internal chamber 92, the purpose of which will presently be described. A flexible strain relief tube 91 is sealably receivable over the extremity of assembly 87 (Figure 10) and a centrally disposed microbore delivery tube 91a is telescopically received int~rn~lly of the extremity in the n~dll,lel shown in Figure 10. During filling of chamber 92, air therewithin can be vented to atmosphere via vent patch 92a.
The flow control means can also co,lll"ise an assemblage of a plurality of layers of permeable materials, P-1, P-2, and P-3 of the character seen in Figure 31 of U. S. Patent ' 10 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 ple~ule 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 in~lic~tcr 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 in~lir~tor means here co~ ,lises an in~ tor base or platform 100, a support or lens plate 102, and a hollow housing 104 within which the platform and the :iu~oll plate are mounted. As seen in Figure 12, plate 102 has a viewing lens 102a which indexes with an ape~llul~ 104a provided in housing 104.
Disposed betw~ell platform 100 and plate 102 are first and second indicia-carrying means shown here as thin films. These films identifi~l here as 106 and 108, are in i.. ~ contact and are coll~llu~;led from a s~-bst~nti~lly lldllspalelll, flexible polymer material such as mylar. The indicia-carrying means need not be thin films, but rather can be any type of surface plese~.li..g member upon which indicia can be provided. The dOwl~ll~alll 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 (Flgure 27), and a red X 107c (Figure 29), each con~i~ting 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 WO 96/34651 PCT/US~ 'nC017 printed with a pattern of diagonal alternating clear and opaque strips 108a that occur in a 1:2 ratio. The printed ratio of the supe~ior "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 ~tt~rhmPnt 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 m~int~inPd 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 Lldl-svc~e displ~r~pmpn~ of the patterns illlplhllcd thereon.
Referring particularly to Figures 3A, 9 and 14, it can be seen that support plate 102 is provided with transversely spaced, ch~nnPl-like depressions 120 and 122 which index with slots 114 and 116 res~ec~ively when the components are assembled in the manner shown in Figures 9 and 14. Aligned with the u~sllca~ll side of slots 114 and 116 are mPch~nir~l actuator means, here provided as mPch~nir~l ac~uato,~ or elastomeric element~
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 ll,am1el plcscl1tly to be described, the mPch~ni~l actuator means are deflected from their initial configuration whenever there is sufficient fluid plc:j~ulc present within the fluid flow path to cause their outward deflection toward thin films 106 and 108. During operation the first mPrh~nir~l actuator elemPnt 124 is deflected by fluid ~les~ulc of reservoir 46. More particularly, when there is sufficient fluid ~c~u,c in the fluid reservoir and fluid is being delivered by the stored energy means of the device, the first niPch~nir~l actuator means is deflected ~u~wa,-dly so as to urge the non-patterned portion 109 of in-lir~tor film 108 into expansion ch~nnPI 122. As the film arches into rh~nn~l 122, the printed portion of the film is transversely displaced a specific ~ t~nre. This film displ~ren Pnt 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 102a (see Figures 1, 26 and 27).
CA 022l9884 l997-lO-30 WO 96/34651 PCT/US~16/~lC017 As can be observed by referring to Figures 28 and 29, both the first and second mechanical elastomeric actuator elements 124 and 126 are infl~t~rl and deflected outwardly toward their respective extension ch~nn~ 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 S caused by blockage of the delivery line do~hl~llta"l from second mrc.h~ni-~l actuator element 126. While element 124 can be deflected by normal line pl~s~ule, element 126 is deflected only by ~le~:~ule buildup res~ in~ from the dowll~tle~lll blockage. When both m.of~h~nic~l actuators are deflected outwardly, bolh 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 apt:llule of the support plate (see Figures 28 and 29).
A third ~lignmPnt of symbol patterns as shown in Figures 24 and 25 is visible when the device is in an unfilled state or when the delivcry line is open, the reservoir is empty and fluid delivery to the patient has been completcd. In this case, there is no fluid ples~ule in the line on either the u~Ll~,alll or d~wll~lr~alll side of the flow control means and thus both the first and second mechanical ~c tn~tor elc.. b~ l~t~ are in a non-deflected position. In this condition, the inferior and superior films arc not transversely displaced and thus exhibit a third combination of patterns rçsl~lting in a third symbol as, for example, a circle being visible through the viewing apelluie of the support plate (see Figure 25). .~t~l~ting elements 124 and 126 can be precisely tailored to dctlect under various plCS~UICs thereby permitting great apparatus versatility.
' In considering the method of operation of thc device and the "lamlel in which fluid flows through the device, lc;Çelellce should be ma~le particularly to Figures 5, 10, and 12.
During the filling step, the fluid to be di~Jenscd is introduced into reservoir 46 via a fluid inlet conduit 49a (Figure 1) which is Connf~ct~d ~o luer fitting 50. Fluid flowing into the fitting lifts check valve ball 68 against the urging of spring 50c and causes the distendable nlelllb~ e 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 at-mosphere 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 fluid 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 toreturn toward a less distended configuration causing fluid within the reservoir to flow CA 022l9884 l997-lO-30 WO 96/34651 PCT/US9"~,C017 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 fluid entering chamber 68 of member 70 from passageway 82 and u~L~ l of membrane 66 can by pass flow rate control mernher 66 and flow directly toward an ear-shaped extension 76a provided on ~ member 76 via flow passageways 76b and 76c. From passageway 76c, the fluid will flow under ~les~ e 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 protubc;l~nce 71 formed on end wal1 70c of substrate 70. This co~ luction permits the fluid flowing into ear-shaped protuberance 76a to flow through passageway 70a and impinge directly upon flow in-lir~tor element 124 which sealably engages the protuberance, c<...~ g it to deform outwardly in a manner to force portion 109 of inflir~tor film 108 to arch into expansion channel 122 (Figure 26). This, in turn, will cause Llan~v~l~e displ~t~emPnt of in-lir~tor film 108 in the manner previously described.
As inrlir~t.ocl in Figure 28, fluid flowing through passageway 82 of disc-shapedmember 76 will also be distributed over the upstream face of the rate control membrane 66 by the fluid di~l. ibulion 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 92 of outlet port assembly 87. The fluid will then flow outwardly of the device through fluid outlet 90 to which an infusion line 93 is connPct~l (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 l~les~ul~, F-2 will impinge upon in-lir~tor element 126 c~ in~ it to deflect outwardly in the manner shown in Figure 28. This outward deflection of element 126 will urge a portion of in~lir~tor film 106 into receiving channel 126 of the lens plate c~ ing Llall~v~lse movement of film 106 so as to reposition film 106 relative to film 108. Should fluid flow into chamber 92 cease, in-lir~tor 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 Llleleby once again c~nsing the "O" symbol to be viewable through the viewing WO 96/34651 PCT/US~ 60~17 lens.
The method of the invention for constructing a fluid delivery device of the character described in the prece~ling paragraphs will now be described. Refcl,h~g to Figure 30, one type of apparatus for accomplishing the first step of one form of the method of the S invention is there dia~ ir~11y illustrated. This initial step of the method co~ ,lises .cimnlt~n~ous stretching the elastomeric membrane subst~nti~lly ullirollllly7 dirrc~cllLially~
uniaxially, or biaxially using a stretching means of the general chala~;Lcr shown in Figure 30. This membrane stretching means here colll~ es a stretching, or elongation fixture 150 which functions to controllably stretch the elastomeric membrane 34 in the mallllcl shown in Figure 30. SLlcLcllillg fixture 150 includes four ciL~;u~llrclellLially spaced membrane gripping assemblies 154, each having gripping elem~nt~ 156 for ~,lip~ g the edges of the elastomeric, isotropic membrane 34. Each of the gripping assemblies 154 is affixed to a slide block 158 which is slidably movable along a pair of tracks 160 by means of a screw assembly 162 which is carried by an end plate 160a provided on tracks 160. Each screw assembly 162 colllplises a threaded rod 162a, one end of which is connloctr~l to a slide block 158. As the threaded rod is rotated by means of a handle 162b, the slide block, along with its associated gripping elem~nt 156, will move outwardly relative to the center of membrane 34 causing it to extend OuLwal-lly. A manual vernier 166 is provided on each screw assembly for in~lir~ting the extent of movement of the slide block relative to the membrane.
Turning to Figure 30A, another type of apparatus usable in callyill~, out the method of the invention is there illustrated. This apparatus also includes a membrane stretching fixture 167 which functions to controllably radially stretch the elastomeric membrane 34 in the manner illustrated in Figure 30a. SLIc~ lg fixture 167 inrl~lflrs a plurality of circumrclclllially spaced mPrh~nir~lly ~rt~ tr~l membrane ~,lippillg assemblies 171, each having gripping çl(~ 171a (Figure 30B) for gripping the edges of the isotropic membrane. Each of the gripping assemblies 171 is mounted on a support table "T", which also ~uL,polL~ the mPch~nic~l equipment for operating assemblies 171. This type of e~luil,mcllL is of a character well known to those skilled in the art. As the gripping assemblies are ~ct~ cl, the gripping elemrntc wiil move radially ouLwdldly relative to the center of membrane 34 causing it to extend outwardly a predetermined amount.
Also forming a part of the apparatus of Figure 30A is a centrally disposed sonic CA 022l9884 l997-lO-30 WO 96/34651 PCT/US9~'0~017 welding apparatus 173, the purpose of which will ~l~selllly be described. Surrounding the sonic welder are vacuum operated article pick-up devices 174a, 174b, and 174c which can be used to position the cover portion of the fluid delivery devices relative to the membrane during the assembly operation. Each of these pick-up devices includes a gripping member 174d which is rotatable about a support shaft 174e.
Referring next to Figure 31, following l,re~liessillg of membrane 34, using either -the fixture shown in Figure 30 or the fixture shown in Figure 30A, the next step in the method of the invention col.lplises affixing the ~le~ ;ssed membrane 34 to the periphery of the base portion 38a of ullage substrate 38. This is accomplished by moving capture housing 40 dOwllwaldly relative to base portion 38a in a ,l.amler such that ~ ,ssed membrane 34 will be securely clamped between the peripheral portions of base 38a and the peripheral portion of capture housing 40. As the capture hoùsing is moved toward the base, which is typically ~.lppolled beneath membrane 34, the membrane will engage and conform to the ullage defining means or protuberance 44 in the mdmler illustrated in Figure 31 (see also Figure 3B).
As previously ~li.ccllcc-ed herein, capture hullsing 40, as well as membrane 34, can be illtelco.~.-P~ A with base portion 38a in any suitable l,.allllel- well known to those skilled in the art, such as adhesive or sonic bonding. In the embodiment of the invention shown in Figures 30 and 31, base portion 38a is provided with a capture groove 59 and an ~ ?lçent tongue 60. Capture housing 40, on the other hand, is provided with a capture tongue 61 and a groove 62 which closely receives tongue 60 as the capture housing moves into engagement with base portion 38a in the manner shown in Figures 5, 6, and 31.
Base portion 38a is also provided with an l-pst~n-iing membrane cutting means orprotuberance 155 which cil~;u.l.iclibes tongue 60 and functions to cleanly cut membrane 34 upon capture housing 40 eng~ing base portion 38a. Protube-dllce 155 also uniquely functions as an energy director for sonic weldment of housing 40 to base 38a.
Sim~ nPously with the cutting of the membrane, the capture hollsing can be sonically welded to the base portion in the proximity of protube~dllce 155 through use of a sonic welder 173 (Figure 30A) by techniques well understood by those skilled in the art. After the sonic welding step, the capture plate and membrane are securely, sealably ~ ,rco..~-Pcted with the base portion. Manipulation of the capture housing can be accolllplished using the pick-up devices shown in Figure 30A when this type of fixture is CA 022l9884 l997-lO-30 WO 96/34651 PCTIUS9~'0li017 used.
Turning now to Figure 32, the next sequential steps in the practice of the method of the invention are there illustrated. More particularly, after hlLelcom1ection of the membrane and the housing with base portion 38a to form a base assembly 175, cover 36 S is connPcterl to base assembly 175 to form a fluid delivery reservoir assembly 177 of the character depicted in Figure 32. Cover 36 can be interconn.oct.orl with base assembly 175 by any suitable means such as adhesive bonding or sonic welding.
The next step in the present form of the method of the invention is to connect :~u~po,L structure 70 of the rate control assembly of the invention with fluid delivery reservoir assembly 177. This step is accomplished in the manner previously described herein by inselLi"g wings 86 of support 70 into the wing-receiving ape,Lu,~s 88 formed in base portion 38a. Following insertion of wings 86 into apertures or sockets 88 (Figure 7), wings 86 are secured in place by any suitable bonding means such as adhesive bonding or sonic welding to form the controlled fluid delivery subassembly 179 (Figure 32).This done, the final step in this form of the method of the invention cv.l~,isesi"Lt;,.;o~ octing hou~ing 104 of the in~ tor assembly 181 with the control delivery assembly 179.
Turning now to Figure 33, another novel form of the method of the present inventionistheredia~,a....~.Atir~llyillustrated. Inaccordancewiththiscontinuousassembly type m.-.tho-l of the invention, the el~tomPric membrane, which is to be hllelco~ cle~l with base 38a, col"~.ises a length of ela~l~J"le.ic membrane 34a that is controllably removed from a first roll 183. Roll 183 colllplises a long length of ela~oll.~lic membrane material that has been wound upon a spindle 185 which is suitably mounted for rotation about its Lld~ e axis so that the membrane material can be controllably unrolled thelerlolll.
After a length of elastomeric membrane is removed from roll 183, it is hlLtlco~ l with a series of longitll-lin~lly spaced clamps or ~ li~e.~ 187 (Figures 34 and 34A) which co",prise a part of a ~imlllt~n~ous biaxial stretching means which is used to controllably ~ e~s the membrane. The biaxial stretching means can take several forms, but preferably co"~p,ises a tenter apparatus 188 of the general character illustrated in Figure 34. While a number of different types of tenter ~ppdldLus have been suggested in the past and their design and operation is well known to those skilled in the art, a tenter apparatus of the general character described in German patent 1,504,479 issued to Erwin CA 022l9884 l997-lO-30 WO 96/34651 PCT/US~5. ~a'017 Kampf can be used in modified form to accomplish the biaxial ~Iretc;llh~g step of the inventlon.
As best seen in Figure 34, as the membrane is unrolled from roll 183, it is introduced into the tenter apparatus 188 in a ,l,ani~er such that the edges of the membrane S are ~ipped by gripping clamps 187. These gripping clamps are, in turn, operably associated with elongated endless chain assemblies "C" and with guide rails "R" (Figures 34 and 34A), so that as the chains move about rotating sprockets "S" and dirrG,G"Lial screws "DS", the clamps diverge so as to controllably impart biaxial stretching forces to the membrane c~sinp~ it to be stretched in the manner illustrated in Figures 33 and 34.
Stretching is accomplished simnlt~nrously in the m~(~hinr direction oriGllL~lion (MDO) and in the transverse direction orientation (TDO). It is to be understood that the ~GIchillg ratios can be precisely tailored to each axis to provide the desired initial strain energy density and extension pattern of the ~1ictenrl~hle membrane. Under certain ci~ es, the extension values for the MDO axis may be different than the ext~-n~i-)n values for the TDO axis. It is to be appreci~t~cl, however, that in the same i~ res, no ~lG~ tch of the membrane will be desired and the tenter frame apparatus will not be used.
After the di~tçn~l~ble membrane has been applol,liately stretched to produce a prestressed membrane 34a of the desired biaxial ~1imrn~ion (Figure 33), it is positioned over the upper surface of base portion 38a. This done, capture housing 40 is placed over membrane 34a and base portion 38a in a l"a,."el- to urge a peripheral portion of the p-G~ c~sed membrane into engagement with base 38a. Next, the ~ ,L.essed membraneis cut and then, along with capture housing 40, is affixed to base 38a by any suitable bonding tçrhni~le such as m~rh~nir~l or adhesive bonding or sonic welding. Following the cutting step the rçm~ining e~ o...~lic membrane material is wound about a take-up drum 190 in the Illalll,el shown in Figure 33 for later salvage. It is to be understood that the ~,G~L,essed membrane can be of considerable width so that a plurality of side-by-side housings 40 can be placed over the membrane siml-1t~nrously and the membrane can then be cut at a plurality of side-by-side locations. The housings and the cut membranes can then be sim~lt~nrously joined with a plurality of bases 38a disposed in a side-by-side relationship bellc~lLh the membrane.
After membrane 34a and capture housing 40 have been affixed to base 38a to form base assembly 175 (Figure 32), the next sequential steps in the device assembly are CA 022l9884 l997-lO-30 WO 96/34651 PCT/US9G/C~017 accomplished in the manner illustrated in Figure 32 and as previously described herein in connection with the earlier described method of the invention.
Referring finally to Figure 35, yet another novel form of the method of the present invention is there diagr~mm~ti~ ~lly illustrated. In accordance with this continuous assembly type method of the invention, the stored energy source, which is to be interconnPcted with the base 38a, com~lises a length of ela~loll.elic l~min~te 34b that is formed by controllably removing lengths of membrane material from three rolls of material. These rolls,~esign~te(l as 200, 202, and 204, each c-,lll~lise a long length of elastomeric membrane material that has been wound upon a spindle which is suitably mounted for rotation about its transverse axis so that the membrane material can be controllably unrolled from each of the rolls.
After a length of elastomeric membrane is removed from each of the rolls 200, 202, and 204, the lengths are brought into contact to form a l~min~te construction 34b. This l~min~te co~ u~lion is then h~lel~o....~octed with a series of lon~ih--lin~lly spaced clamps 187 (Figure 34) which co."pli~e a part of the previously described biaxial stretching means which is used to controllably pl~l,ess the membrane. As before, the biaxial ~Llelchillg means can take several forms, but preferably c~lllplises a tenter appdldlus 188 of the general character illustrated in Figure 34.
As the membrane l~min~te 34b is formed in the lllal,l,er shown in Figure 35, it is introduced into the tenter apparatus 188 so that the edges of the l~ tr are gripped by gripping clamps 187. As shown in Figure 34, these gripping clamps are, in turn, associated with elongated endless chain assemblies "C" and guide rails "R" so that as the chains move about rotating sprockets "S", and dirrtl~.,lial screws "DS", the clamps diverge so as to controllably impart biaxial stretching forces on the l~min~te c~sin~ it to be controllably biaxially stretched.
After the ~ ten-l~ble elastomeric membrane l~min~te has been apploL,lidtely stretched to produce the ple~l,essed l~min~te 34b the l~min~t~ is po.~ition~ over the upper surface of base portion 38a. This done, capture housing 40 is placed over the l~min~te and base portion 38a in a nldlmel to urge a peripheral portion of the l~min~t~ into engagement with base 38a. Next the l~min:~te is cut and then, along with capture housing 40, is affixed to base 38a in the ,l,aml~l previously described. Following the cutting step, the rem~ining elastomeric membrane l~min~t~ material is wound about a take-up drum 190 for later WO 96/34651 PCT/U~ '0~017 salvage.
After l~min~t~ 34b and capture housing 40 have been affixed to base 38a to form base reservoir assembly 175 (Figure 32), the next sequential steps in the device assembly are accomplished in the manner illustrated in Figure 32 and as previously described herein 5in comleclion with the earlier described embodiment of the invention.
- 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 m~king changes and modifications in the individual parts or their relativc assembly in order to meet specific requi,~l.le.l~s or conditions. Such changes and modifications may be made without 10departing from the scope and spirit of the invention, as set forth in the following claims.
Claims (32)
1. A device for use in infusing medicinal fluid into a patient at a controlled rate comprising:
(a) a base;
(b) stored energy means for forming, in conjunction with said base a fluid reservoir having 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) an outlet port for dispensing fluids from the device; and (d) 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) a base;
(b) stored energy means for forming, in conjunction with said base a fluid reservoir having 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) an outlet port for dispensing fluids from the device; and (d) 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 port 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 3 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.
5. A device as defined in Claim 4 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.
6. A device as defined in Claim 5 further including flow control means disposed between said fluid outlet of said reservoir and said first and second actuator elements for controlling fluid flow through said outlet port.
7. A device as defined in Claim 6 in which said flow control means comprises a permeable membrane through which at least a portion of said fluids to be infused flows.
8. A device as defined in Claim 7 in which one of said first and second actuator elements is movable by fluid flowing from said reservoir through said permeable membrane and the other of said first and second actuator elements is movable by fluid flowing from said fluid reservoir and by passing said permeable membrane.
9. A device as defined in Claim 7 in which said first and second thin films are substantially transparaent and in which at least one of said first and second thin films carries indicia.
10. A device for use in infusing medicinal fluid into a patient at a controlled rate comprising :
(a) a base;
(b) stored energy means for forming, in conjunction with said base a fluid reservoir having an outlet, said stored energy 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) an outlet port in communication with said outlet of said reservoir for dispensing fluids from the device; and (d) flow control means disposed intermediate said outlet of said reservoir and said outlet port for controlling the rate of flow of fluid from the device, said flow control means comprising:
(i) a permeable membrane; and (ii) support means for supporting said permeable membrane within the path of fluid flowing from said outlet of said reservoir toward said outlet port.
(a) a base;
(b) stored energy means for forming, in conjunction with said base a fluid reservoir having an outlet, said stored energy 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) an outlet port in communication with said outlet of said reservoir for dispensing fluids from the device; and (d) flow control means disposed intermediate said outlet of said reservoir and said outlet port for controlling the rate of flow of fluid from the device, said flow control means comprising:
(i) a permeable membrane; and (ii) support means for supporting said permeable membrane within the path of fluid flowing from said outlet of said reservoir toward said outlet port.
11. A device as defined in Claim 10 in which said support means of said flow control means includes fluid distribution means for distributing fluid flowing from said outlet of said reservoir toward said permeable membrane.
12. A device as defined in Claim 10 in which said support means of said flow control means includes fluid collection means for collecting fluid flowing through said permeable membrane and directing said fluid toward said outlet port.
13. A device as defined in Claim 10 further including fluid actuated indicator means disposed intermediate said flow control means and said outlet port for visually indicating fluid flow from said reservoir.
14. A device as defined in Claim 13 in which said indicator means comprises first and second at least partially overlaying indicia-carrying thin films, said films being movable relative to each other in response to fluid flowing from said fluid reservoir, whereby selected portions of said indicia becomes visible.
15. A device for use in infusing medicinal fluid into a patient at a controlled rate comprising:
(a) a base;
(b) stored energy means for forming, in conjunction with said base a fluid reservoir having a fluid inlet and a outlet, said stored energy means comprising a distendable member superimposed over said base, said member being distendable toestablish internal stresses, said stresses tending to return said member to less distended configuration to urge fluid flow through said fluid outlet;
(c) an outlet port for dispensing fluids from the device; and (d) 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, said indicator means comprising:
(i) a pair of thin films disposed in an overlaying relationship, at least one of said thin films having indicating indicia viewable upon relative movement of said films; and (ii) actuator means communicating with said fluid outlet for moving at least one of said thin films relative to the other in response to fluid pressure being exerted on said actuator means.
(a) a base;
(b) stored energy means for forming, in conjunction with said base a fluid reservoir having a fluid inlet and a outlet, said stored energy means comprising a distendable member superimposed over said base, said member being distendable toestablish internal stresses, said stresses tending to return said member to less distended configuration to urge fluid flow through said fluid outlet;
(c) an outlet port for dispensing fluids from the device; and (d) 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, said indicator means comprising:
(i) a pair of thin films disposed in an overlaying relationship, at least one of said thin films having indicating indicia viewable upon relative movement of said films; and (ii) actuator means communicating with said fluid outlet for moving at least one of said thin films relative to the other in response to fluid pressure being exerted on said actuator means.
16. A method of making a device for infusing medicinal fluid into a patient at a controlled rate, said device having a base provided with an upper surface including a central portion and a peripheral portion circumscribing the central portion, a distendable, elastomeric membrane superimposed over the base, a housing engageable with the base, and a cover covering the housing, the method comprising the steps of:
(a) stretching the distendable membrane to produce a prestressed membrane;
(b) placing the prestressed membrane over the upper surface of the base;
(c) emplacing the housing over the base and the prestressed membrane;
and (d) sealably connecting the prestressed membrane and the housing to the base.
(a) stretching the distendable membrane to produce a prestressed membrane;
(b) placing the prestressed membrane over the upper surface of the base;
(c) emplacing the housing over the base and the prestressed membrane;
and (d) sealably connecting the prestressed membrane and the housing to the base.
17. A method as defined in Claim 16 in which the membrane is stretched biaxially.
18. A method as defined in Claim 16 including the further step of capturing and then cutting the prestressed membrane as the housing is emplaced over the base.
19. A method as defined in Claim 18 including sealably bonding the housing to the peripheral portion of the upper surface of the base.
20. A method as defined in Claim 19 in which the housing is sonically bonded to the peripheral portion of the upper surface of the base.
21. A method as defined in Claim 19 in which said device includes a cover covering the housing and in which the method includes the further step of connecting the cover to the housing.
22. A method of making a fluid delivery device for use in infusing medicinal fluid into a patient at a controlled rate having a generally plate like base provided with a fluid outlet and an upper surface including a central portion, a distendable elastomeric membrane superimposed over the base, a housing engageable with the base, one of said housing and said base having a groove and the other one a tongue receivable within said groove, and a cover covering the housing, the method comprising the steps of:
(a) stretching the distendable membrane to produce a prestressed membrane;
(b) placing the prestressed membrane over the upper surface of the base;
(c) emplacing the housing over the base and the prestressed membrane such that the membrane is clamped between the tongue and the groove;
(d) cutting the prestressed membrane at a location proximate the tongue to provide a cut, prestressed membrane; and (e) sealably interconnecting the cut prestressed membrane and the housing with the upper surface of the base to form a base assembly.
(a) stretching the distendable membrane to produce a prestressed membrane;
(b) placing the prestressed membrane over the upper surface of the base;
(c) emplacing the housing over the base and the prestressed membrane such that the membrane is clamped between the tongue and the groove;
(d) cutting the prestressed membrane at a location proximate the tongue to provide a cut, prestressed membrane; and (e) sealably interconnecting the cut prestressed membrane and the housing with the upper surface of the base to form a base assembly.
23. A method as defined in Claim 22 in which the housing is bonded to the base by sonic welding.
24. A method as defined in Claim 22 including the further step of connecting the cover to said base assembly to form a fluid delivery assembly.
25. A method as defined in Claim 24 in which the fluid delivery device includes a flow rate control assembly for controlling fluid flowing from the fluid outlet of the base and in which the method comprises the further step of connecting the flow rate control assembly to the fluid delivery assembly to form a controlled delivery assembly.
26. A method as defined in Claim 25 in which the fluid delivery device includes a fluid flow indicator assembly for indicating fluid flow from the fluid outlet of the base and in which the method comprises the further step of connecting the fluid flow indicator assembly to the controlled delivery assembly.
27. A method of making a device for infusing medicinal fluid into a patient at a controlled rate, said device having a base provided with an upper surface including a central portion, a distendable, elastomeric membrane superimposed over the base, and a housing engageable with the base, the method comprising the steps of:
(a) removing a first length of elastomeric membrane from a first roll of elastomeric membrane;
(b) stretching said first length of distendable membrane to produce a first prestressed membrane;
(c) placing the first prestressed membrane over the upper surface of the base;
(d) emplacing the housing over the base and the first prestressed membrane; and (e) sealably connecting the first prestressed membrane and the housing to the base.
(a) removing a first length of elastomeric membrane from a first roll of elastomeric membrane;
(b) stretching said first length of distendable membrane to produce a first prestressed membrane;
(c) placing the first prestressed membrane over the upper surface of the base;
(d) emplacing the housing over the base and the first prestressed membrane; and (e) sealably connecting the first prestressed membrane and the housing to the base.
28. A method as defined in Claim 27 in which the membrane is stretched biaxially.
29. A method as defined in Claim 27 including the further step of cutting said length of prestressed membrane as the housing is emplaced over the base.
30. A method as defined in Claim 27 including the further steps of removing a second length of elastomeric membrane from a second roll of elastomeric membrane including:
(a) stretching said second length of distendable membrane to produce a second prestressed housing over the base prior to emplacing the membrane; and (b) placing the said second prestressed membrane over said first prestressed membrane.
(a) stretching said second length of distendable membrane to produce a second prestressed housing over the base prior to emplacing the membrane; and (b) placing the said second prestressed membrane over said first prestressed membrane.
31. A method as defined in Claim 30 including the further steps of removing a third length of elastomeric membrane from a third roll of elastomericmembrane including:
(a) stretching said third length of distendable membrane to produce a third prestressed housing over the base prior to emplacing the membrane; and (b) placing the said third prestressed membrane over said second prestressed membrane.
(a) stretching said third length of distendable membrane to produce a third prestressed housing over the base prior to emplacing the membrane; and (b) placing the said third prestressed membrane over said second prestressed membrane.
32. A method of making a device for infusing medicinal fluid into a patient at a controlled rate, said device having a base provided with an upper surface including a central portion, a distendable, elastomeric membrane superimposed over the base, and a housing engageable with the base, the method comprising the steps of:
(a) removing a first length of elastomeric membrane from a first roll of elastomeric membrane;
(b) removing a second length of elastomeric membrane from a second roll of elastomeric membrane and placing said second length of elastomeric membrane over said first length of elastomeric membrane to form an elastomeric laminate;
(c) stretching said elastomeric laminate to produce a prestressed laminate;
(d) placing said prestressed laminate over the upper surface of the base;
(e) emplacing the housing over the base and the prestressed laminate;
and (f) sealably capturing and connecting the said prestressed laminate and the housing to the base.
(a) removing a first length of elastomeric membrane from a first roll of elastomeric membrane;
(b) removing a second length of elastomeric membrane from a second roll of elastomeric membrane and placing said second length of elastomeric membrane over said first length of elastomeric membrane to form an elastomeric laminate;
(c) stretching said elastomeric laminate to produce a prestressed laminate;
(d) placing said prestressed laminate over the upper surface of the base;
(e) emplacing the housing over the base and the prestressed laminate;
and (f) sealably capturing and connecting the said prestressed laminate and the housing to the base.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/430,221 US5496064A (en) | 1994-04-26 | 1995-04-28 | Inflator assembly having partitioning member redirecting gas flow |
| US08/430,221 | 1995-05-01 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2219884A1 true CA2219884A1 (en) | 1996-11-07 |
Family
ID=23706591
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2219884 Abandoned CA2219884A1 (en) | 1995-04-28 | 1996-05-01 | Fluid delivery apparatus and method of making same |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2219884A1 (en) |
-
1996
- 1996-05-01 CA CA 2219884 patent/CA2219884A1/en not_active Abandoned
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