CA1063475A - Liquid infusion unit - Google Patents

Liquid infusion unit

Info

Publication number
CA1063475A
CA1063475A CA219,297A CA219297A CA1063475A CA 1063475 A CA1063475 A CA 1063475A CA 219297 A CA219297 A CA 219297A CA 1063475 A CA1063475 A CA 1063475A
Authority
CA
Canada
Prior art keywords
liquid
liquid drug
cartridge
infusion unit
bladder
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA219,297A
Other languages
French (fr)
Inventor
Richard G. Buckles
Seymour Hoff
Sharon Kehr
Su I. Yum
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Alza Corp
Original Assignee
Alza Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Alza Corp filed Critical Alza Corp
Application granted granted Critical
Publication of CA1063475A publication Critical patent/CA1063475A/en
Expired legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/148Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags
    • A61M5/152Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags pressurised by contraction of elastic reservoirs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M39/28Clamping means for squeezing flexible tubes, e.g. roller clamps

Abstract

A B S T R A C T
A liquid infusion unit for infusing liquid drug continuously into a patient at a controlled rate is disclosed. The unit comprises: a housing that is adapted to be attached to the patient; a removable, refillable liquid drug cartridge that fits into a recess in the housing exterior; a liquid drug flow passageway enclosed within the housing whose inlet connects with the cartridge outlet; an adjustable flow controller in the passageway that regulates precisely the flow rate of liquid drug; a conduit connected to the outlet of the passageway that extends to the infusion site; and a catheter or needle connected to the end of the conduit that is inserted into the patient at the infusion site.

Description

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Many uses exist for devices that can dispense a small amount ., of liquid at a precisely metered rate. One such use is the infusion of various liquids, including liquid drugs, at accurate, reproducible flow rates to a patient. The prior art is generally cognizant of such devices, :
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. -' - . 1063475 as exemplified by U.S. Patent No. 2,842,123 to Rundhaug that shows a transfusion apparatus having a collapsible bag for the fluid and a pressure container in sealed relationship about the outside of the bag; U.S. Patent No. 2,847,007 to Fox that discloses a flexible fluid pouch within a resilient container for storing whole blood or plasma; U.S. Patent No. 3,469,578 to Bierman that illustrates an infusion device having a spigot valve for ambulatory use; and U.S. Patent No. 3,486,539 to Jacuzzi, that shows a liquid dispensing device having a restricted outlet passage.
Such devices, while generally satisfactory, have proven to be disadvantageous in many respects. For example, a number of these devices are functional, but only in very crude forms. Complexity in manufacture, awkward operation, and the aesthetically displeasing mechanical appearance of such .: . .
~; devices have hindered eYen their limited acceptance in the - -i marketplace. More importantly, devices heretofore available, .~.
when manufactured on a production-line basis, exhibit liquid discharge characteristics varying widely from device to device;
varying as the liquid contents are dispensed; and at very low flow rates in the range of 0.1 to 10 cc per hour varying from one flow setting to another. These failings make such devices unsuitable for uses where variable amounts of fluid are being passed, the amounts passed must be known with exactness, the , fluid must be dispensed at a consistent rate, calibration after each flow adjustment i5 either impossible or inconvenient, ^ and the displeasing appearance of an overly mechanical assemblage must be minimized.
Accordingly, the need has arisen for a much improved device for the storage and precise dispensing at reproducible low flow rates of fluids, such as liquid drugs, especially in , ~ -2-:.. ~ . . . . ... ., , , _ ,: . .. , .
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3 1063~75 connection with medi.cal applications s.uch as. the infusion of such drugs to a patient. Furthermore, such a need is particularly evident in those applications where certain drugs are pre~erably applied at a continuous, low rate over relatively long periods of time in dosage levels which would preclude application of such medications other than by direct local infusion to the affected area.
STATEMENT OF: THE INVENTION
The invention is a liquid infusion unit for infusing ; 10 liquid drug continuously into a patient at a controlled rate characterized by:
.. (a~ a housin~ aaapted to he attached to the patient and having a recess in its exterior surface;
(~b) a liquid drug flow passageway enclosed within the - housing and having an Inlet and an outlet;
(c) a cartridge adapted to contain liquid drug under :~
pressure that removabl~ fits within the recess in the housing ~ such that the uni.t has a smooth, contiguous exterior surface, the cartridge ha~ing an outlet for the li.quid dxug that connects with the inlet of (b~ when the cartridge. is fitted in the recess;
(d) a flow controller i.n (b) between the inlet and . outlet of (.b) that regulates precisely the flow rate of liquid drug through (b); and (:e~ a condui.t connected to the outlet of (~) that extends to the infusion site.
As used herein and in the claimsr the term "liquid drug" includes drugs that are liquid in their natural form, solutio~s of dxugs and other liquid formulations of drugs.

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B'RIEF :DES'CRIP:TION QF THE DRA~INGs Figure 1 is a perspective view of a preferred embodiment of an intrayascular infusion un~t of the present invention;
Figure 2 is a top plan view, parti.ally in section, of the infusion unit of Figure l;
Figure 3 is a sectional view, partially in elevation, of a portion of the flow control assembly of the infusion unit ; . .
.' of Figure l; ~ .

: 10 Figure 4 is an exploded perspective view of the ... . .
.. infusion unit of Figure 1 ~ith. certain parts broken away and .~

... certain parts shown in section; .' ' Figure 5 is a bottom plan vie~ of the infusion unit .' of Figure l;

:.- Figure 6 is an exploded pers.pective view of the fluid 'Y' repository cartri.dge of the infusion unit of Figure l; and :~ Figure 7 is a sectional view of a detail of the valve :.

'~ assembly of the'cartridge of F~gure 6. ~ :
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' 'DE~A'IL~ '-DESC~IPTTON: OF q~HE ::~ENTION
~ 20 Referring to Figure 1, the preferred embodiment of .,`~ the infusion uni.t of the invention includes a main housing 10 .i :
h.aying a generally rectangular support hase 12 upon which are ;j~ maunted the Yarious subassembLi.es comprising the complete unit.
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~ Support base'12 is prefexabLy sli.ghtly curved to conform to the .~3 :~ curYature of either a particular portion of the torso of a patient or an extremity such. as an arm or a leg.

The' i.llustxated unit i.s particularly well suited for : use on the''arm or leg of a patient, and in order to maintain~' : the infusion unit in position thereon, any of various suitable attaching mechanisms, assembl:ies or devices may be employed, .~ .
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such as a pair of adjustable elastic bands 14 and 16 affixed to the underside of the base 12. Alternative devices to straps 14, 16 are synthetic or metallic clips or bracelets; suitable belts or straps provided with cloth fasteners, zippers or buckles; or elastic or inelastic ties or adhesive tapes.
. Mounted on support base 12 are two spaced, elongated :
compartments or housing sections 18 and 20 each having a generally triangular cross section as shown in Figures 1 and 4.
Compartment 20 i5 defined by a generally flat, upright interior wall 22, an outwardly and downwardly inclined floor 24, and a generally flat inclined outer wall 26. The end of compartment : 2Q, to the left as seen in Figure 1, i.s closed by a triangularly-shaped wall 28 that is contiguous at i.ts periphery with walls 22, 26 and the support base 12.
Compartment 18 has along its inner side a generally upright wall 3Q that extends from support base 12 to the upper edge of a flat, inclined outer wall 32 that joins base 12 along its longitudinal edge. The left end o~ compartment 18, as seen in Figures 1 and 4, is closed by a triangular, upright wall 34, 20 with. the opposite end of the co~partment 18 open and recessed from the edge of support base 12 in a manner similar to that of compartment 2~. A convex wall 36 of generally triangular confi.gurati.on has a s~oothly rounded inwardly directed flange formed about its upper periphery and closes the right end of the unit by joining ~alls 26 and 32 wlth support base 12.
~` A locking le~es 4Q is journalled at an end 42 for .. ~ pivotal rotation about a pin 44 protruding inwardly from upriqht ~all 30 of compart~ent 18. End 42 further supports a , ~ :

_5_ i063475 flange 46 for cooperatiye engagement wi.th a protrusion (.not shown) on wall 3Q so as to limit the degree of upward swing of lever 4Q away from support base 12. The other end 48 of lever 40 carries a downwardly extending, generally flat plate 50. A locking tang 58 protrudes laterally below the bottom edge of plate 50 for cooperative engagement with an aperature . ~' 60 (,Fig. 5) defined in support base 12. Lever 40 also carries a generally triangular, curYed outer wall 62 that acts as a h.andle and is shaped such.that lever 4Q/ when in a closed or locked position, is contiguous at its outer s.uxface boundaries with the outer surfaces of compartment 18.
Referring to Figure 4, floor 24 of compartment 20 carri.es a plurali.ty of protrusions that cooperate with the components of the flo~ control sys:tem shown in Figure 3. Lead-ing to the flow control system is a generally U-shaped flow .::
passage defined ~y element 70. that terminates at one end in a needle-like`protrusi;on 72 ha.Ying a hole 74 that communicates with.a small, generally c~lindrical intexiox chamber 76. Spaced from the fxont ~all of chamber 76 by an ~-ri.ng 78 is a filter assembl-~ 8Q consïst~ng of one or more. fllters designed to xetain small p~a~xticles oX se.diment and b.acteria and preclude the pa5sage o~ the same through the downstream portions of the flow control assembly.
Downstream of filtex ass.embly 8Q i.s. a flow passage 82 defined ~y a g~oo~e in the outer wall of element 70 and a flat plate 84 attached thereoYer. Passa:ge 82 extends through an elbow 86 in element 7a and di~erges outwardly to provide an nteri,or ch~m~ex B8. It i.s noted that elem,ent 7Q is constructed so as to join with ~ase`12, the edge of end piece.36, and ..

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, ~063475 upstanding walls 22 and 30 at the right ends of compartments 18 and 20. Element 70 thus functions as an end wall of the generally rectangular recess 90 on top of base 12 between chambers 18 and 20 and closes off the compartment joining compartments 18 and 20.
Chamber 88 has a first outlet 92 and a second, smaller outlet 94 disposed si.de-by-s;de in a wall 96. Outlets 92 and 94 protrude slightly from the outer surface of wall 96 and are attached in sealed reIationship, to flexible, fluid carrying conduits 98 and 100, respectively. As shown in Figure 4, a ~ generally rectangular upstandi.ng block 102 is formed in floor ; 24 of compartment 20 and includes a pai.r of longitudinally aligned upstanding divi.ding walls lQ4 and 106. Walls 104 and 106 are spaced from each other such that the space between them . will accommodate flexible conduit lQ0, wi.th larger flexible conduit 98 dis-posed on the other side of wall 106. -Conduits 98 and 100 terminate at their opposite ends in a connect;`:ng block. 108 hav~ng i.nlets llQ and 112 similar to inlets 92 and 94, respectiveLy, and accommodating the ends of flexible conduits 98 and 10Q in a fluid-tight manner. Connector block 108 i.s~prefexably rectangular, but may be shaped other-wise. Block. 108 has a groove runni.ng completely around it for firm engagement with a generally U-sh.aped, upstanding pxotrusion 114 i.n floor 24 of compartment 2Q.
~ chamber 116 insi.de of block 108 provides communica-tion between i.nlets llQ and 112 and an outlet 118 for connection through th.e floor of compartment 20 with a flexible surgical tube 120. The end of tube 120 i.s connected with a cathe~er or needle ~or infusion of fluids: to a patient.
Disposed inside of condui.t 98 are a plurality of fibers 122 .~ that are nested coextensiveIy in a close relationship and fill a substantial portion of the cross-sectional area of conduit 98.

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`` 1063475 A sprin~ 124 (Fi.g. 21 is. held at its. proximal end in . a recess 126 adjacent to elbow 86 i.n floor 24 of compartment 20 and has at its distal end an offset, curved portion that : engages flexible conduit 100. Spring 124, when disposed in :- recess 126, exerts a ~iasing force against the flexible conduit '- 100 so as to pinch. the same between its curved offset portion . and the side of wall 106. Thus, spring 124 normally precludes '. the passage of fluid ihrough conduit lQ0 and enables fluid ,~ flow therethrough.only when it is lifted away from wall 106. : .
~' 10 A generally triangular wedge 128 is mounted on the opposite side of flexible conduit 98 from wall 106 and is ~. slidable laterally into engagement with.such conduit in a path ,. defined by stops 13Q and 132 in the floor of compartment 20.
. A control wedge 134 is disposed adjacent wedge 128 such that .,~ longitudinal ~ovement of the control wedge 134 urges wedge 128 '~;., into engagement ~ith flexl~le. conduit q8 and compresses the conduit between ~edge 128, upstanding wa.ll 106, the floor of ,.~ block 102 and wall 26. Such compressi.on distorts conduit 98 such that the area th.ere,i.n de:creases resulting in fibers 122 taking up more of the available space wi.thin the conduit for fluid flow-. At th left e.nd of control wedge 134, as seen in ~ Figuxe 2, a rack gear 136 is provided h.aving a guide prong .~ 138 protruding from its le~t end s-o as to slide against the .;~ front corner of compaxt~ent 2a. ~ poînting arm 140 extends from ~ the left end of rack gear 136 in a direction opposite to -'~ projection 138 and has ~ scribed line for cooperation with a flow xate scale. 144 on the outside of ~all 26 (,Fi.g. 1). Pointer .
14Q.can ~e seen through, an opening 146 in w.all 26 and, since '-:
1 the longitudinal poition of rack 136 de.termines the lateral ,l 30 position of wedge 128, indicates the flo~ rate of setting of I fluid ~eing dispensed through the infusion unit. ~
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An aperture 148 is defined by the wall 26 for admitting one end of a tool 150 having a pinion gear 152 formed thereon for interengagement with the gear teeth of rack 136. As indicated in Figure 1, tool 150 may be inserted through aperture 148 and rotated so as to longitudînally move control wedge 134 for regulating the force applied through wedge 128 to conduit 98. The flow rate thus- established is accurately maintained and is precisely indicated by the position of pointer 140 on scale 144.
. 10 Chamber 116 in connector block 108 defines a hole 158 -. -opposite inlets 110 and 112, that is closed by a flexible diaphragm 16Q sealed by an annular clamp 162. Diaphragm 160 thus moves in response to the pressure within the system between inlet 110 and outlet conduit 120. ~n L-shaped indicator arm 164 is pivotall~ mounted to the floor 24 of compartment 20 and has a first leg 166 that engages and responds to movement of diaphragm 160. Th.e other leg 168 of leYer 164 carries a flag or signal 17Q. Signal 170 may be painted ~ith a bright color or provided ~ith an~ other suitable i.ndicia and has an arcuate path o~ tra~el th.at bisects an aperture 172 in wall 26.
In addi.ti4n, a small biasing spring 174 is torsionally wound about the axis a~ arm 164 between leg 168 and a stop 176 in the floor o~ compartment 20.
In this manner, arm 164 is gently biased such that leg 166 engages the diaphragm 160., with leg 168 carrying signal 170 to a nested position hidden behind wall 26 away from aperture 172. Should the fluid flowing through the system to the catheter or needle become blocked, the pressure of the fluid supply cause~ diaphragm 160 to bulge outwardly from connector b.lock 108 thereby rotating arm 164 and transposing signal 17Q to a position behind aperture 172. The visual _g_ .s ~ .

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perception of signal 170 through aperture 172 notifies the patient or his attending physician or nurse that infusion has ceased. The above described flow indicator is entirely optimal.
A plurality of grooves such as orthogonal grooves 180, 182 and 184 are formed in the undersurface of support base 12 in order to allow conduit 120 to be guide~ along the bottom - of base 12 and brought out to the front, rear or side of the infusion unit for ultimate connection t~ the catheter at the end of the conduit in the most convenient manner. Any number ; 10 of such grooves may be provided in the undersurface of support base 12.
A cartridge assembly 200 formed of left and right - cartridge halYes 202 and 204, respectively, has a generally rectangular cross section and conforms to recess 90 between compartments 18 and 20. The upper surfaces of halves 202 and 204 are slightly curYed such that when the cartridge is slid ; into recess 90 and arm 4Q is pivoted to its locked position, the overall unit has a smooth, contiguous outer surface as shown in Figure 1. HalYe 204 has an end wall 2Q6 defining an aperture 2Q8. Aligned oYer aper*ure 208 is a valve assembly 210 of a di6tensible fluid-containing bladder 212. Valve assembly 210 is attached to wall 206 in any suitable manner such !, as by means of clamps, bolts, ox interlocking grooves.

The basic element of valve assembly 210 is a flat, :.
resilient member 214 having a pair of frustoconical apertures 215 that, as shown in Figure 7 in solid lines, is urged by the internal pressure with~n the bladder into a closed position in sealed eng~gement with wall 206. Alternatives to valYe 210 are a simple flap ~alYe or a flexible seal adapted to be s 30 punctured by a needle for admitting or dispensing fluid. Such al$~rnati~es ~ould require modification of projection 72 or -` substitution of a sharp needle therefor.
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~063~75 The opposite end of bladder 212 defines an opening 216 having an annular flange 218. Aligned over opening 216 against the surface of flange 218 is a microfilter 220 which allows the passage of air but not fluid.
Microfilter 220 is firmly clamped between flange 218 and the inner flat surface of a sliding spider 222 having a plurality of arms 224 extending radially from a central hub.
Arms 224 are preferably engaged with the four inner corners of the rectangular shell provided by halves 202 and 204 of cart-ridge 200 such that the spider i5 freely slidable longitudinal-- ly within the shell. An aperture 226 extends completely through the central hub of spider 222 such that air passing through filter 220 may be expelled to the atmosphere. A
generally L-shaped indicating arm 228 protrudes upwardly from the central hub of spider 222 and has~ a first leg that extends over a recessed path 230 longitudinally disposed along a -~
central portion of halve 2Q4. ~ volume scale 232 is imprinted upon the uppex surface of halve 2Q4 and cooperates with indicator arm 228 to indicate the Yolume of fluid in the bladder 212.
Bladder 212 may be distended by the admission of fluid under pressure through valve 210 such that the bladder is axially and radially enlarged, as shown in Figure 2, for stor-ing the fluid under pressuxe. As the fluid is forced into bladder 212, the bladder becomes axially elongated such that spider 222 slides to~ard the end away from the valve 21Q, with pointer 228 indicating the yolume of fluid admitted on scale 232. In addition, s~nce bladder 212 is supported between valve ,ji assembly 210 attached to wall 206 of cartxidge 20Q and the 3a central hub of spider 222, the same is at all times spaced ., .

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~063475 from the inner walls of halves, 202, 204 to allow precise delivery of the entire contents of the bladder with minimal frictional interference. Furthermore, the distensible elastic wall of bladder 212 is constructed so that it distends radially only to approxi.mately the inner dimens,ions of the cartridge 200.
Therefore, even when fully distended, it does not engage the inner walls of halves 202, 204.
A pair of pins 240 and 241 protrude laterally from the ends of a side wall of halve 202 of cartridge 200 for cooperative engagement wi.th the inner edge of plate 50 and flange 46, respectiveIy. Thus, as cartridge 200 is slid into position along support base 12 (:Fi.g. 4~, pin 241 engages flange 46 and as arm 40 is rotated downwardly, pin 240 slides along said inner edge to firmly urge the cartridge into a nested position with'pin 72 inserted through aperture 208 and into engagement with,member 214 of yalye assembly 210. :~
In operation, a particular li~ui.d drug intended to be administered by i,nfusion to a patient is first forced under pressure into bladder 212 through valve assembly 210. An appropriate interface may be formed on the valYe end of cartxidge 20a for cooperati.on with a suppl.y capsule such that the liquid drug supply may be affixed to the cartridge 200 with a needle-like member engagi.ng member 214 of the valYe assembly to open the s:ame for the admission of drug. The incoming drug causes ~Iadder 212 to radi.ally and axially expand to a capac~ty of from ~bout 20 to laa. cc. While the drug is being forced into bladder 212, spider 222 moves axially toward t~e end opposite yalve'assembly 2I0, indicating the volume of drug ~n the ~l'adder by the pos~tion of pointer ar~ 228 on scale 232.

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After bladder 212 has been completely filled, the liquid drug supply is removed from the cartridge allowing member 214 to become firmly seated against wall 206. The cartridge is then ready for use and may be stored under appropriate conditions or immediately inserted into the unit for use. During the filling operation, microfilter 220 allows any air initially contained within the deflated bladder 212 to pass through aperture 226 in spider 222 for assuring complete filling of the bladder with the liquid drug. By tilting the cartridge such that the end opposite valve assembly 210 is in an elevated position, the air trapped within bladder 212 will rise to the top and will be slowly released through filter 220 to the atmosphere. As noted above, microfilter 220 may be of any suitable type, such as that sold under .: .
the trade mark "Celgard", and enables the passage of air but yet -precludes the flow of the liquid drug out of the bladder under bladder pressure, thereby enabling rapid bleeding of the bladder so that it will be filled only with the liquid drug.
` Once the cartridge assembly has been completely filled with ~.,- i .
liquid drug, and it is desired to administer the drug to a patient, .. :
the cartridge may be properly positioned in recess 90 between compart-ments 18 and 20. Preferably, cartridge 200 is positioned at the left end of recess 90, with locking arm 40 in approximately the position illustrated in figure 4. The cartridge is then gently slid to the right between walls 22 and 30. As shown in Figure 2, as the cartridge moves toward the right end of the unit, projecting pin 72 of end membe~r 70 first passes through aperture 20& in wall 206 of the cartridge and, as the cartridge is further advanced, pushes member 214 into its open position ~illustrated in phantom in Figure 7), thereby ',' ;1 . ~. -: ~ ~. . -i - 13 -~ .
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permitting liquid drug to flow thxough apertures 215 and slots or openings (not shown), in the le,ading end of pin 72 and into hole 74.
At this same time, lever 40 must be moved downwardly toward its locking position. This causes pin 240 to slide along the inner edge of plate 50 and urge the cartridge into its properly nested position atop support base 12. After the cartridge is fully seated to the right as shown in Figure 2, lever 40 may be further moved such that the locking tang 58 engages the shoulder of rectangular opening 60 in base 12 and firmly locks the cartridge in place. As indicated in Figure 1, when the cartridge is positioned atop supp~rt base 12, and lever 40 is rotated down into its locked position, the unit has a smooth, continuous exterior surface.
~ ith the cartridge in position atop base 12, the interaction of pin 72 and member 214 allows the liquid drug , .
,, to flow from bladder 212 into fluid passageway 82 formed in the right end of the unit. The drug flows through aperture 74 and into chamber 76 where it must pass through filter 80 thereby , 20 assuring the removal of any bacteria, sediment or other small ; particles ~hich ma~ have inadvertently entered the system.
; While the liquid drugs that might be expected to be administered with the unit will not normall~ contain any large particles the ~iltex 8Q assures the complete removal of such particles, ~, thereby guaranteeing positive metering of drug through the ~!~ fluid flo~ control described belo~.
The fluid passage 82 opens into chamber 88 that feeds ~ both the main fle,xible`conduit 98 and the smaller secondary '`' conduit lQQ. These t~o condu;ts form parallel paths for the 3Q flow of fluid through`the'system with the main conduit provid-, ing precise and accurate metering of drug during normal opera-~i tion and the`s2~ller conduit 100 enabling rapid bypass or ~063475 bleeding of the system during selected times. The controlled flow through the parallel circuit of flexible conduits 98 and 100 passes through connector block 108 and through conduit 120 for infusion. While the particular details of conduit 120 have not been shown, it should be understood that any well-known surgically approved technique may be utilized whereby the conduit 120 terminates in an I.V. catheter or needle for insertion into the patient for administration of the drug or in a standard connector for connection to a catheter or needle.
As described above, a spring 124 ~Fig. 2) has an offset, curved distal end which is normally biased into engage-~ent with conduit loa so as to pinch it against wall 106 and close it to the passage of fluid from cartridge 212. Since the primary flow-through conduit ~8 is a lo~-rate flow, it would take considerable time to bleed any air from the system when initially preparin~ the unit for use. Thus, spring 124 is provided for cooperation with conduit 100 such that as the spring 124 i5 moYed away from the conduit, a secondary flow is enabled through conduit 100 so as to rapidly purge the system of any air. Theseaftex, spring 124 may be released whereupon conduit lOQ ifi again closed. As shown in Figure 1, a generally rectangular opening may be provided in the wall 26 of compart-ment 20 to enable a flat blade of tool 150 to be inserted into compartment 20 for moving spring 124 away from conduit 100.
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Conduit ~8 contains a plurality of coextensively ` disposed, parallel, elongated fibers 122 that substantially fill the conduit. Fibers 122 are essentially linear and are made of a resilient eIastomeric . ~ .

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material, such as the poly(urethane) sold under the trade mark "Lycra Spandex", silicone rubber, polyisoprene and butyl rubber. Since conduit 98 rests in position atop block 102 between wall 106 and a flat side of wedge member 128, a compressive force is applied to the conduit in a direction which is perpendicular to the flow of fluid therethrough.
This compressive force is applied to the conduit at the point where the fibers 122 are disposed, and may be applied over all or part of the length of the fibers.
As a compressive force is applied against conduit 98 by the ; wedge 128, the conduit is deformed. Since the circumference of conduit 98 does not change appreciably, this deformation brings about a decrease in the conduit's cross-sectional area. ~he cross-sectional area of the fibers 122, however, does not change appreciably so that . .
~ as conduit 98 is compressed, the proportion of the space within the conduit taken up by the fibers increases to enable precise metering of fluid flow. Fibers 122 are closely packed within the conduit and generally should take up at least 50 percent of the internal cross-` sectional area of the conduit prior to compression. Preferably, the~ fibers have circular cross sections so that they align in a close-; packed, nested configuration. The number of fibers may vary. As a general rule, there must be at least six fibers and the upper limit, which is not critical, may be as much as several hundred fibers.
In order to precisely control the flow rate through conduit 98, control wedge 134 is disposed in compartment 20 and coacts with wedge `~ 128 such that changing the longitudinal position of control wedge 134 causes very slight movements of wedge 128 perpendicular to the conduit.
In this manner, compressive forces of greater and lesser magnitude are ,1 .

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simply, effectiYely, and reproducibly genexated and applied by wedge 128 to conduit 98. The control wedge 134 carries a rack - gear 136 which, as~ noted above, is accessible through aperture - 148 in wall 26 of compartment 20. Pinion gear 152 of tool 150 may be easily inserted thxough aperture 148 so as to engage rack. gear 136. Rotation of th.e tool chan~es the longitudinal position of control wed~e. 134.
Since the position of control ~edge 134 determines .: the compressive force applied to conduit 98, and thus, the - 10 flow rate of liquid from the unit, the position of pointer arm 140 on scale 144 enables the simple and precise visual perception of the preselected flow rate. Once the desired flow ;
rate has been es:tablished, tool 15Q may be remoYed so as to -~
preclude inadvertent adjustment ox regulation of the flow rate.
Of course, by subsequent reinsertion af the pinion gear 152 of tool 15Q, the flo~ rate ma~ be reset. .
Conduits 98 and loa, fibers 122, and bladder 212 may . be formed of the same materi.al or of different materials.
. While any number of sui.table materials may be utilized, certain I 20 exemplary materials are those which axe xesilient, defoxmable '~, and are inert to the fluid or liquid dxug stored and admin-istered b.y the unit. Exemplary materials include natural rubber (preferably treated to remove impurities which potential-ly would contaminate the fluid~, as well as synthetic i~ elastomers, fox example, poly(isoprene), poly(.. l,4-butadiene), segmented polyuxethane of the poly-ether variet~, block co-~ ox ter-poly.mers containing butadiene and styrene, silicone .. xubbers, but~l rubber, nitrile~butadiene rubber and neoprene.
. ~eferring to ~igure 1, the infusion unit is preferably ~, 3a designed to be ~orn or attached to a portion of the torso or an extremity of a patient and is particularly well-suited for administexing liquid drugs at very slo~ rates over an extended ~:
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period of time to a particular site of disease or infection.
For example, in certain cancer chemotherapy, it may be desirable to apply a particular liquid drug directly to the forearm of a patient where a detected cancer nucleus has formed. In this case, the infusion uni.t is attached to the patient's upper arm or fore.arm ~ith the slight curvature of the lo~er surface of the support base 12 generally conforming to the curvature of the arm. Straps 14 and 16 may be adjusted so that the infusion unit is comforta~ly held in position ab.out the arm of the patient.
The condui.t 120 may then be posi.tioned within one of the orthogonal grooYes 18Q, 182 or 184 along the bottom of base 12 and brought out from that side of the infusion unit closest to the selected point of insertion of the catheter. Desirably conduit 120 i6 of th.e nonclosure type, that is., its passageway .~""t~ '."
is of a generally tri.angular cross secti.on ~hich prevents it ` from being easily pinched off. Preferably, before the infusion `. : unit is attached to the patient, a cartridge 20.0 ~hich has been pre~iousl~ filled wIth.the`desired drug to be administered is slid onto the support base 12 in the manner described above.

: Thereafter, the blade end of tool 15~ may be inserted through the opening in th.e unit's wall to lift spring 124 away from ~ conduit 100 causing the relati.vely rapi.d emission of drug from ; cartri.dge 212 thxough the passage~ay~ inside the infusion unit ; and thence through condui.t 120 and the catheter so as to di.scharge`all of the air present within the flo~ passageway of .i the unit. $pxin~ 124 is thereafter released closing conduit 100 i~ ~ and allow~ng the des~red, prec~seIy me.tered flow rate to be established through`conduit 98.
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. , .
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~. -18-: .: .
. - - .
. .

10t;3475 The catheter is then inserted into the selected tissue or vascular passage associated with the disease site to be treated, and the precise, desired flow rate is preset by insertion and rotation of tool 150 through opening 148. The -- unit will then continuously administer liquid drug to the - patient at the selected flow rate.
The infusion unit is preferably constructed of molded plastic so as to be extremely lightweight and economical to fabricate. Such-molding may be accomplished by well-known techniques and, as such, may be fabricated from a number of individually molded pieces that are assembled to ~orm the unit. -It can therefore be appreciated that the unit provides a number of material advantages over prior devices and allows -precisely reproducible, metered flow rates of liquid drugs to be administered to a patient by infusion by apparatus which is economical, simple, aesthetically pleasing, and allows the patient to be at all times ambulatory while undergoing treatment.
Further, the infusion unit may easily accommodate any number of replaceable cartridges containing the same or different liquid drugs for administration to a patient at various times, each cartridge being refillable or disposable after such patient has completed the intended treatment.
~ Inasmuch as the present invention is subject to many ,; variations, modifications and changes, it is intended that all matter contained in the foregoing description or shown in the accompan~ing drawings shall be interpreted as illustrative and not limiting.
.. ', .
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.: :

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, . . . . . . . .
.. . .. .. .. . .

Claims (18)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A liquid infusion unit for infusing liquid drug continuously into a patient at a controlled rate characterized by:
(a) a housing adapted to be attached to the patient and having a recess in its exterior surface;
(b) a liquid drug flow passageway enclosed within the housing and having an inlet and an outlet;
(c) a cartridge adapted to contain the liquid drug under pressure that removably fits within the recess in the housing such that the unit has a smooth, contiguous exterior surface, the cartridge having an outlet for the liquid drug that connects with the inlet of said liquid drug flow passageway when the cartridge is fitted in the recess;
(d) a flow controller in said liquid drug flow passageway between the inlet and outlet of said liquid drug flow passageway that regulates precisely the flow rate of liquid drug through said liquid drug flow passageway; and (e) a conduit connected to the outlet of said liquid drug flow pass-ageway that extends to the infusion site.
2. The liquid infusion unit of claim 1 characterized by the housing having a generally crescent-shaped cross section and being comprised of a concave bottom wall, a convex top wall and two opposed end walls.
3. The liquid infusion unit of claim 2 characterized by the recess having a rectangular cross section and being located axially in the top wall with one end opening through one end wall of the housing and the opposite end being closed by the opposite end wall of the housing.
4. The liquid infusion unit of claim 3 characterized by the cartridge having a cross section that conforms to the recess cross section and a top wall of the same convexity as the top wall of the housing.
5. The liquid infusion unit of claims 3 or 4 characterized by the inlet of said liquid drug flow passageway being in the surface of the opposite end wall of the housing that defines the closed end of the recess.
6. The liquid infusion unit of any of claims 1, 2 or 3 characterized by said liquid flow passageway having a filter in it between its inlet and said flow controller.
7. The liquid infusion unit of any of claims 1, 2 or 3 characterized by said liquid drug flow passageway being connected to a flow indicator that is responsive to the hydraulic pressure within said liquid drug flow passage-way.
8. The liquid infusion unit of claim 1 characterized by said liquid drug flow passageway including a bypass of said flow controller.
9. The liquid infusion unit of claim 1 characterized by the cartridge comprising a hollow shell having a cross section that conforms to the recess cross section and a top wall of the same convexity as the top wall of the housing, and a generally cylindrical elastomeric bladder that is contained axially within the shell and is adapted to contain the liquid drug under a self-generated pressure.
10. The liquid infusion unit of claim 9 characterized by the cartridge including a valve assembly connected to one end of the bladder, the valve assembly defining the cartridge outlet and being attached to the inside of an end wall of the shell.
11. The liquid infusion unit of claim 10 characterized by the cartridge including a spider attached to the other end of the bladder whose arms slid-ably engage the inside of the shell, the valve assembly and spider supporting the bladder within the shell such that the bladder wall is at all times spaced from the longitudinal walls of the shell.
12. The liquid infusion unit of claims 10 or 11 characterized by the other end of the bladder being closed by a microfilter that permits air but not liquid to pass.
13. The liquid infusion unit of claims 9, 10 or 11 characterized by the top wall of the shell having an axial aperture whose axial edge carries a bladder volume scale and one arm of the spider acts as a bladder volume indicator in cooperation with the bladder volume scale.
14. The liquid infusion unit of claims 9 or 10 characterized by the cartridge comprising a hollow shell having a cross section that conforms to the recess cross section and a top wall of the same convexity as the top wall of the housing, and a generally cylindrical elastomeric bladder that is con-tained axially within the shell and is adapted to contain the liquid drug under a self-generated pressure and a valve assembly connected to one end of the bladder, the valve assembly defining the cartridge outlet and being attach-ed to the inside of an end wall of the shell, the inlet of said liquid drug flow passageway being defined by a needle-like protusion that extends axially from said surface and penetrates the valve assembly when the cartridge is seated in the recess, thereby opening the valve and permitting the liquid drug to flow from the bladder into said liquid drug flow passageway.
15. The liquid infusion unit of claim 4 characterized by the unit in-cluding a locking lever pivotally attached to the housing that engages the cartridge and locks it in place within the recess.
16. The liquid infusion unit of claim 1 characterized by the flow controller comprising a deformable conduit through which the liquid drug flows, a plurality of parallel, linear elongate fibers disposed coextensively in the conduit and an adjustable pincher disposed about the conduit for pinching the conduit to varying degrees whereby the flow rate of liquid drug may be varied.
17. The liquid infusion unit of claim 16 characterized by the pincher being a pair of wedges disposed on opposite sides of the conduit facing each other, one of the wedges being fixed and the other wedge being axially movable and the top wall of the housing having a hole in it providing access to the axially movable wedge to move the same.
18. The liquid infusion unit of claims 16 or 17 characterized by the top wall having an aperture with a flow rate scale on one of its edges and the axially movable wedge carrying a pointer that cooperates with the flow rate scale to indicate the flow rate.
CA219,297A 1974-02-04 1975-02-03 Liquid infusion unit Expired CA1063475A (en)

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US439137A US3895631A (en) 1974-02-04 1974-02-04 Liquid infusion unit

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CA1063475A true CA1063475A (en) 1979-10-02

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US (1) US3895631A (en)
JP (1) JPS5422718B2 (en)
AR (1) AR203226A1 (en)
AT (1) AT355195B (en)
BE (1) BE824703A (en)
BR (1) BR7500707A (en)
CA (1) CA1063475A (en)
CH (1) CH591248A5 (en)
DE (1) DE2504048A1 (en)
DK (1) DK16375A (en)
ES (1) ES434296A1 (en)
FI (1) FI750291A (en)
FR (1) FR2272686B1 (en)
GB (1) GB1484394A (en)
IE (1) IE42702B1 (en)
IL (1) IL46521A (en)
IT (1) IT1027456B (en)
NL (1) NL168136C (en)
NO (1) NO135119C (en)
SE (1) SE408018B (en)
ZA (1) ZA75546B (en)

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Also Published As

Publication number Publication date
GB1484394A (en) 1977-09-01
ES434296A1 (en) 1976-12-16
IL46521A0 (en) 1975-04-25
SE408018B (en) 1979-05-14
NO135119C (en) 1977-02-16
NL7501132A (en) 1975-08-06
FI750291A (en) 1975-08-05
NO750318L (en) 1975-09-01
IE42702L (en) 1975-08-04
AT355195B (en) 1980-02-25
NL168136C (en) 1982-03-16
FR2272686A1 (en) 1975-12-26
BR7500707A (en) 1975-11-11
DE2504048A1 (en) 1975-08-07
AU7781975A (en) 1976-08-05
JPS50108790A (en) 1975-08-27
DK16375A (en) 1975-09-22
US3895631A (en) 1975-07-22
NO135119B (en) 1976-11-08
SE7501133L (en) 1975-08-05
ZA75546B (en) 1976-01-28
ATA72975A (en) 1979-07-15
NL168136B (en) 1981-10-16
AR203226A1 (en) 1975-08-22
JPS5422718B2 (en) 1979-08-08
DE2504048B2 (en) 1979-05-23
CH591248A5 (en) 1977-09-15
FR2272686B1 (en) 1982-02-12
IT1027456B (en) 1978-11-20
IE42702B1 (en) 1980-10-08
IL46521A (en) 1977-11-30
BE824703A (en) 1975-05-15

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