Note: Descriptions are shown in the official language in which they were submitted.
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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
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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
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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
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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
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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.
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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
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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
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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
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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.
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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
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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,
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WO 96/34651 PCT/US96/06047
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
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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).
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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
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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
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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
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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
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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
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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
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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.
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