Ulllted States Patent [19]
`Tamari
`
`US006039078A
`[11] Patent Number:
`[45] Date of Patent:
`
`6,039,078
`*Mar. 21, 2000
`
`[54] INLINE EXTRACORPOREAL RESERVOIR
`AND PRESSURE ISOLATOR
`
`1/1970 Leroy ........................................ .. 251/5
`3,490,732
`5,061,365 10/1991 Utterberg ................................ .. 210/90
`
`[76] Inventor: Yehuda Tamari, 21 SingWorth St.,
`Oyster Bay, NY. 11771-3703
`
`P 1’ imary Examiner—]0hn FOX
`[57]
`ABSTRACT
`
`[ * l
`
`Notice?
`
`Thi_5 Pawnt is Subject to a terminal dis‘
`Clalmer-
`
`The speci?cation describes several uses for pressure sensi
`tive valves during eXtracorporeal pumping in one
`embodiment, an improved pumping loop for a roller pump
`is used in an eXtracorporeal circuit With a pressure relief
`valve and pump tubing. The inlet and outlet of the tubing are
`connected respectively to the outlet and inlet of said valve
`via tWo 3 Way connections, across the outlet of the pump.
`The pumping loop alloWs recirculation of pumped liquid
`between the Inlet and 9mm of the pump When the Outlet
`Pressure generated by Sald Pump exceeds a Set Value thereby
`limiting the pump outlet pressure to the set pressure. The
`pressure relief valve can also be placed at the inlet if the
`pump to protect the circuit from excess negative pressure
`that the pump can generate. The pressure relief valve in
`
`[21] Appl. No.: 08/474,267
`.
`_
`Flled'
`
`[22]
`
`Jun‘ 7’ 1995
`Related U S A H cati on D ata
`'
`' pp
`Continuation-in-part of application No. 07/852,931, Mar.
`13, 1994, Pat. No. 5,186,431, which is a continuation of
`application No‘. 07/683,093, ‘Apr: 10, 1992, abandoned,
`Whlch 1S abcolglnuilnon of apphcatlon N°~ 07/410345: SeP~
`2’ 1989’ a an one '
`[51] Int. Cl.7 .................................................... .. F16L 55/04
`
`[63]
`
`[52] US, Cl, _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
`
`_ _ _ _ __ 138/30; 604/4
`
`combination With the pump loop provides an accurate means
`
`[58] Field of Search ............................... .. 251/4, 5; 604/4,
`604/5; 138/30
`
`[56]
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`te dyhamieally Set the eeehleieh ef the tubing Within the
`roller pump. Other applications for the pressure sensitive
`device include inline noninvasive pressure isolator, and
`pressure relief across other devices. Various designs are
`introduced.
`
`2,575,240 11/1951 Thompson ............................ .. 257/5 X
`
`7 Claims, 9 Drawing Sheets
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`U.S. Patent
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`Mar. 21, 2000
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`Sheet 1 0f 9
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`6,039,078
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`Mar. 21, 2000
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`6,039,078
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`1
`INLINE EXTRACORPOREAL RESERVOIR
`AND PRESSURE ISOLATOR
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`This application is a continuation in part of allowed
`application U.S. Ser. No. 07/852,931 ?led Mar. 13, 1992,
`US. Pat. No. 5,186,431, Which Was a continuation of US.
`Ser. No. 07/683,093 ?led Apr. 10, 1992, noW abandoned,
`Which Was a continuation of US. Ser. No. 07/410,845 ?led
`Sep. 2, 1989, noW abandoned, all of Which Were entitled
`“Pressure Sensitive Valves For Extracorporeal Circuits”,
`application 999,217, ?led Dec. 31, 1992, US. Pat. No.
`5,305,982, and alloWed application U.S. Ser. No. 08/016,
`034, ?led Feb. 10, 1993, both of Which Were continuation in
`part of the aforementioned U.S. Ser. No. 07/852,931, appli
`cation U.S. Ser. No. 07/669,641 ?led Mar. 14, 1991, US.
`Pat. No. 5,215,540; entitled “Innovative Pumping System
`For Peristaltic Pumps”; and US. Ser. No. 876,627 ?led May
`6, 1992 entitled “A Compact LoW Cost Pressure Regulating
`System” Which contain similar pressure sensors and control
`systems, the disclosures of these applications being incor
`porated herein by reference thereto.
`
`BACKGROUND OF THE INVENTION
`
`10
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`15
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`20
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`25
`
`The ?eld of the invention is extracorporeal circulation of
`blood outside a patients’ body, and particularly pressure
`sensitive devices to control blood How and pressure in the
`extracorporeal circuit While reducing hemolysis.
`
`30
`
`DESCRIPTION OF THE PRIOR ART
`
`2
`silicone, and its compliance or the pressure at Which it
`collapses is not adjustable by the user. Also, With this
`chamber the blood sees three different materials (PVC
`tubing to polycarbonate connector to silicone rubber) and
`three physical junctions, all of Which contribute to throm
`bosis. Material and physical discontinuities also make it
`more dif?cult, if not impossible, to apply a continuous
`heparin coating, an anticoagulant that inhibits thrombosis, to
`the circuit. US. Pat. Nos. 4,515,589 and 4,767,289
`(manufactured by Sarns/3M Corp. as the “Safety Loop”),
`and US. Pat. No. 4,650,471, describe devices to be used
`With the roller pump that prevent too much suction. The
`former provides no adjustment over the pressure about
`Which How is controlled. The ’471 patent describes adjust
`ment capabilities for the inlet, but neither provides relief for
`overpressuriZation at the outlet of the pump.
`The only pressure sensitive valve that is knoWn to be used
`clinically in the extracorporeal circuit is the one incorpo
`rated at the inlet to the “Safety Loop” mentioned above. Its
`assembly is labor intensive and requires multiple parts. In
`addition, its housing is exposed to atmosphere and provides
`no mechanism to adjust the interluminal pressure. Senko
`Medical Instrument Mfg. Co., LTD. of Tokyo, Japan manu
`factures a pressure relief valve intended for dialysis that is
`placed at the outlet of an ultra-?ltration device to maintain
`its pressure constant independent of the ?oW. It is made by
`sealing a thin Wall plastic diaphragm betWeen the tWo
`thicker Walls of a tube, the diaphragm separating the pres
`sure port and the blood path. This valve, hoWever, has
`physical discontinuities along the seal betWeen the thin and
`the thick Wall tubing, creating areas of stagnation Which are
`prone to thrombus formation. In addition, the housing is not
`optically clear, Which prevents the user from observing
`Whether the valve is open or closed, and the pressure port is
`perpendicular to the thin membrane, again reducing the
`clarity required for observation of valve open state.
`In the medical ?eld, valves knoWn as Starling resistors,
`are made of a thin Walled sleeve and require negligible
`transWall pressure difference to close them. They have been
`suggested for use to maintain or adjust pressure, (Robert
`Rushmore: Control of Cardiac Output, in Physiology and
`Biophysics 19th edition Ruch TC and Patton HD editors,
`WB Saunders Co. Phil. 1965).
`These valves made of a sleeve sealed in a housing With
`means to pressuriZe the interluminal space (the space
`betWeen the housing and the sleeve). Pressure applied to the
`interluminal space acts upon the Wall of the sleeve forcing
`the opposite Walls of the sleeve to meet and close shut. This
`external force on the Wall is counteracted by the pressure
`Within the lumen of the sleeve Which tends to keep the Walls
`apart. It is the net force of these tWo vectors that determines
`Whether the sleeve is opened, closed or in betWeen.
`In industry, these valves are used as ON/OFF valves or as
`adjustable resistors knoWn as pinch valves. Pinch valves are
`also used to adjust the resistance to How using an external
`roller that pinches and thus controlling the degree of closure
`of the sleeve. If the Wall of the sleeve is made suf?ciently
`thin, the valve can also be used to transfer the pressure of the
`?uid Within the sleeve to the interluminal space Without
`signi?cant changes in the transducer pressure. Thus, these
`devices can transmit the pressure of a ?uid that may be
`corrosive to a pressure gauge While isolating the pressure
`gauge from the ?uid.
`US. Pat. No. 4,767,289 teaches that a Starling valve may
`be made of a thin Wall tubing, each end of Which is sealed
`to a rigid connector Which in turn is sealed to the housing,
`
`35
`
`40
`
`Blood is routinely pumped outside the body during
`dialysis, cardiopulmonary bypass and long term cardiac
`and/or respiratory support (e.g., extracorporeal membrane
`oxygenation, ECMO). TWo types of pumps are used: the
`roller and the centrifugal pump. With the roller pump, and to
`some extent With the centrifugal pump, a decrease in blood
`supply at the pump inlet, Without a concomitant decrease in
`pump speed, can cause excessive suction leading to air
`embolism, thrombosis and damage by the “venous” cannula
`to the vessel’s intima. Similarly, an obstruction at the pump
`outlet can also result in excessive outlet pressure.
`To overcome these potential dangers in closed systems
`such as ECMO or dialysis, bladders, placed at the inlet to the
`pump, collapse When inlet pressure drops beloW atmo
`spheric pressure, actuating a microsWitch that stops the
`pump and restarts When the bladder re?lls. This system
`provides no control over the degree of suction the pump
`generates. These knoWn prior art reservoirs (such as GISH
`BIOMEDICAL Santa Ana Calif.) are designed to operate
`horiZontally, Which forms a loW ?oW region Where red cells
`tend to accumulate and thrombosis is likely to occur. A
`reservoir designed to eliminate gravitational accumulations
`55
`Would increase clinical safety of bypass procedures.
`Pressure measured directly With a liquid ?lled line Which
`connects a pressure transducer to the blood, requires a sterile
`transducer for each application, provides no compliance for
`smooth pump operation, and has blood stagnating in the
`pressure monitoring lines. Pressure measured via a pressure
`isolator (e.g., Pressure Barrier Kit 3 made by American
`Omni of Costa Mesa Calif. 92626) alloWs for damping
`controlled by the amount of air on one of its sides but it has
`a much higher stagnant blood volume than direct
`measurements, thereby increasing the chances of thrombo
`sis. The only available compliance chamber is made of
`
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`providing a ?oW through chamber. US. Pat. No. 4,515,589
`teaches that the Walls of the thin Wall tubing may extend
`beyond the housing, be folded upon themselves and sealed
`over the external Wall of the housing. These techniques have
`one or more of the following disadvantages: 1) the thin Wall
`tube is stressed over the edges of the housing, 2) the
`assembly requires sealing the thin Wall tube to the
`connectors, 3) the discontinuities of the valve at the con
`nection site betWeen the thin Wall and the thick Wall tubing
`can create turbulence and trapped vortices, a leading cause
`of thrombus generation, 4) the assembly is labor intensive
`and requires multiple parts, and 5) control over the interlu
`minal pressure With present systems is provided by a cum
`bersome and bulky combination requiring a compliance
`chamber, a pressure manometer and interconnecting tubing.
`US. Pat. No. 4,250,872 by Tamari illustrates a valve
`made of unitary tubing, a portion of Which has been
`expanded and thinned to alloW easy contraction by external
`?uid pressure. HoWever, the Way this valve Was made, it
`could not fully close (as illustrated in FIG. 5) nor Was it
`preformed to close completely. None of the aforementioned
`devices are suggested for use directly at the pump outlet, a
`placement that alloWs the greatest protection for the entire
`circuit.
`In?atable elastomeric bladders have been used for pres
`sure indication and regulation (e.g., part no. BSVD-300,
`Shiley, Laboratories, Irvine, Calif., and Buckels US. Pat.
`No. 3,993,069). The pressure-volume characteristics of
`these balloons have a high or loW frequency hysteresis,
`and/or the highest pressure occurs upon initiation of in?ation
`and thereafter it decreases (e.g., see FIG. 1 of US. Pat. No.
`3,993,069, and FIG. 6 of Tamari’s US. Pat. No. 5,013,303).
`The Shiley device is a spherical balloon and therefore upon
`in?ation its siZe, but not its shape, changes. Neither device
`alloWs the user to adjust the pressure. It Would be useful to
`have a pressure regulator With a shape change Which indi
`cates pressuriZation more clearly. It Would also be of great
`advantage to provide the user With the means to adjust the
`maximum outlet pressure of pumps and incorporate inex
`pensive means to measure noninvasively the pressure of the
`pumped ?uid.
`Hemolysis by roller pumps is due to crushing of blood
`cells betWeen the Walls of the tubing being squeeZed and/or
`high shear rates possible With retrograde ?oW through
`nonocclusive tubing. Pump occlusion is set by measuring
`the drop rate of a column of liquid at the outlet of a stopped
`pump. Drop rates anyWhere from 1 to 40 cm/min per 100 cm
`pressure difference are reported in the literature. The drop
`method has ?ve major disadvantages: inaccuracy because of
`relatively large variation in tubing Wall thickness (10.003“),
`unequal extension of the tWo rollers, off center roller
`rotation, pump raceWays that are not truly circular and,
`during fast drop rates, the pressure decreases as the liquid
`falls. Thus, proper occlusion setting requires averaging of
`multiple readings Which is a time consuming effort.
`Although it is reported by Bernstein and Gleason (Factors
`in?uencing hemolysis With roller pumps, Surgery,
`61:432—442, 1967) and Noon et. al. (Reduction of blood
`trauma in roller pumps for long-term perfusion, World J.
`Surgery 9:65—71, 1985) that hemolysis increases as the
`occlusion is increased, for very nonocclusive settings the
`drop rate is too fast to measure accurately. Others have
`suggested that roller occlusion be set by measuring a pres
`sure drop at the outlet of the pump. With this method, the
`pump outlet is clamped, the pump is rotated to increase the
`pressure to the desired level, the pump is then stopped, and
`the rate of pressure drop measured. Occlusion setting by this
`
`10
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`6,039,078
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`4
`method is very dependent on the compliance betWeen the
`pressure transducer and the roller occluding the tubing: the
`larger the compliance the loWer the occlusion. Both afore
`mentioned methods use a stationary pump, referred to here
`after as static tests Which rely on a measurement taken from
`a single point along the pump raceWay and from a single
`roller to determine occlusion. It may be that one of the
`reasons that users generally do not set the pumps in a less
`occlusive manner, is the dif?culty in doing so accurately. It
`Would be of great clinical advantage to be able to provide
`control over the maximum pressure in an extracorporeal
`circuit and the maximum suction the patient is exposed to,
`as Well as to provide a simple means to enable the user to set
`the pump nonocclusively and provide a standard roller pump
`With the advantages of a centrifugal pump Without its
`associated high costs. These can be done With pressure
`sensitive valves and appropriate control devices.
`
`SUMMARY OF THE INVENTION
`The present invention is a unique pressure sensitive
`device, Which is used in combination With an extracorporeal
`circuit to control ?oW, pressure and blood handling devices
`therein. In one embodiment, the pressure sensitive device
`and pump tubing are interconnected via 3-Way connectors,
`to limit excess pump pressure in a peristaltic pump used for
`extracorporeal circulation. In another combination, a pres
`sure sensitive valve that is normally open is placed at the
`inlet to the roller pump and is used to limit the negative
`pressure applied to said extracorporeal circuit. The device
`can also be used to accurately set the occlusion of said
`peristaltic pumps as Well as to measure blood pressure
`noninvasively.
`The present invention may be formed in various embodi
`ments each consisting of a polymeric tubing With at least one
`?exible thin Wall section, said section sealed Within a
`housing With a port to form a ?rst pressure chamber. The thin
`Wall section is designed to reduce the pressure required to
`move the thin Wall section and can be used for various
`purposes. Its nominal diameter may be greater than, equal to
`or smaller than the inside diameter of the tubing it is formed
`in or connected to. In one embodiment, the thin Wall section
`can, for example, be incorporated Within a housing to form
`a pressure relief valve. The tubing for the pressure relief
`valve is preferably made of a single, inde?nite length,
`uniform, smooth, ?ssureless, thermoplastic, elastomer
`Which is ?exible and clear, a section of Which has been
`processed and sealed Within the housing to form ?rst pres
`sure chamber therebetWeen. The pressure in the ?rst pres
`sure chamber is adjusted via a port. Thus, When the pressure
`in the ?rst pressure chamber is greater than the pressure
`inside the thin Wall processed section, the valve is closed,
`and When the pressures are reversed, the valve is open.
`When the pressure relief valve is placed betWeen the inlet
`and outlet of a pump, the user can adjust the maximum outlet
`pressure of the pump by adjusting the pressure applied to the
`?rst pressure chamber. When the pump outlet pressure
`reaches the set pressure, the pressure relief valve opens,
`alloWing excess pressure to be relieved by recirculating
`some of the ?oW. The pressure in said ?rst pressure chamber
`can, for example, be controlled by an elastic balloon or by
`other mechanisms to be described herein. The pressure
`sensitive device can also be used to accurately set the
`occlusion of peristaltic pumps as Well as to transmit pressure
`from the ?rst pressure chamber, to thereby alloW noninva
`sive inline pressure measurement. In other designs to be
`described, the processed section, When having an enlarged
`diameter, can be used as an inline reservoir With an adjust
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`able compliance providing both noninvasive pressure mea
`surement and an inline reservoir.
`In another embodiment, the present invention may be
`integrally incorporated into blood tubing intended for use in
`an eXtracorporeal circuit to regulate blood ?oW there
`through. This embodiment uses a length of unitary extra
`corporeal tubing interconnected in the eXtracorporeal circuit.
`The tubing has a ?rst outer diameter and a ?rst Wall
`thickness, With a thin Wall portion de?ned intermediate the
`ends of the tubing. The device also includes a housing
`having an inner diameter at each end thereof Which snugly
`engages the tubing. The housing has a port formed therein
`Which communicates With a sealed interluminal chamber
`formed betWeen the thin Wall tubing portion and the hous
`ing. Each end of the housing extends beyond the thin Wall
`portion to engage the tubing along the ?rst outer diameter.
`Apressure regulating means is then connected to the port,
`to provide a predetermined pressure response to the blood
`?oW. A pressuriZed ?uid betWeen the pressure regulator
`means and the thin Wall portion Will actuate the valve When
`the interluminal pressure varies from the intercorporeal
`pressure Within said thin Wall tubing by at least the amount
`required to overcome the elastic force of the thin Wall
`tubing. It is particularly intended to be incorporated in an
`eXtracorporeal circuit for circulation of blood, Wherein the
`circuit has a plurality of blood treatment devices and a
`plurality of blood compatible tubing members With connec
`tors therebetWeen for circulation of blood therethrough.
`In the present invention a pressuriZed elastic sleeve may
`be used to regulate the pressure and provide a predetermined
`pressure response for the pressure sensitive devices. The
`regulated pressure may be positive or negative pressure.
`The present invention may also be formed as an improved
`pump loop for use With a roller pump in eXtracorporeal
`circulation. When used in this manner, the loop includes a
`?rst tubing segment for insertion in a roller pump for
`pumping eXtracorporeal ?uids therethrough. The tubing has
`a pump inlet and a pump outlet and a shunt tubing for ?uid
`connection of the pump outlet to the pump inlet. A pressure
`relief valve is then provided for closing the shunt tubing
`beloW a predetermined pressure. The pressure relief valve
`may further include a thin Wall tubing portion formed in the
`shunt tubing betWeen said pump outlet and said pump inlet,
`or may include a thin Wall section mounted betWeen said
`pump outlet and said pump inlet, either one of Which is
`surrounded by a housing.
`The present invention may also be formed as a system for
`regulating pressure in an eXtracorporeal circuit, Wherein the
`system includes an eXtracorporeal circuit for circulation of
`blood through a plurality of devices for circulating and
`treating blood, Wherein each device has a blood inlet side
`and a blood outlet side. Ashunt tubing is provided to bridge
`one of the devices by connecting the outlet side to the inlet
`side. Apressure responsive valve is mounted in the shunt to
`normally close the shunt tubing beloW a predetermined
`pressure. The pressure responsive valve Will thus open to
`alloW blood ?oW through said shunt When the blood pressure
`in the shunt is greater than said predetermined pressure.
`Alternately, the pressure responsive valve may be posi
`tioned at the inlet side of the pump to prevent eXcess suction
`that can be generated by the pump for reaching the patient.
`The pressure responsive valve is then formed to be normally
`open above a predetermined pressure at said pump inlet and
`closed When the pressure at the pump inlet drops beloW the
`predetermined pressure.
`The invention may also be used to set pump occlusion for
`eXtracorporeal roller pumps having at least tWo rollers for
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`sequentially occluding a tubing member to pump an eXtra
`corporeal ?uid therethrough, Wherein a shunt tubing mem
`ber interconnects the pump outlet and the pump inlet. A
`pressure relief valve then closes the shunt tubing member
`beloW a predetermined pressure. A means is provided for
`indicating ?uid ?oW from the pump outlet to the pump inlet,
`and a clamp is used to clamp the pump outlet distal to the
`tubing member While the pump occlusion is adjusted. The
`desired occlusion is then obtained by adjusting the setting of
`the adjustable roller to generate a pump pressure essentially
`equal to the predetermined pressure.
`The present invention may also be used to provide a
`noninvasive pressure monitoring system for pumps. This
`combination includes a length of tubing having at least one
`thin Wall portion, a pump having a drive means for pumping
`?uid through the tubing and a pressure isolating chamber
`surrounding the thin Wall portion, the chamber having a
`monitoring port de?ned therein Which is connected to a
`transducer means. The transducer means is then connected
`to the drive means for controlling the speed of the pump, and
`varies pump speed When the pressure in the tubing varies
`from a predetermined value.
`The present invention also includes a noninvasive pres
`sure monitoring system for roller pumps. This system
`includes a length of polymeric, unitary, ?ssureless tubing
`having ?rst and second thin Walled portions With a roller
`pump engaging section therebetWeen and a roller pump
`having an adjustable drive means. The inventor also includes
`?rst and second pressure isolating chambers surrounding
`said ?rst and second thin Walled portions respectively. Each
`of the ?rst and second chambers has ?rst and second
`respective monitoring ports de?ned therein. A variety of
`means are then connected to the monitoring parts.
`The present invention also includes an inline reservoir for
`use in an eXtracorporeal circuit to provide compliance for
`blood ?oW therethrough. The reservoir includes a length of
`unitary eXtracorporeal tubing, interconnected in the extra
`corporeal circuit, With a ?rst outer diameter and ?rst Wall
`thickness, and an enlarged thin Wall portion de?ned inter
`mediate the ends of the ?rst Wall tubing. A housing is
`provided Which snugly engages the outer diameter of the
`tubing. The housing has a port therein, Which communicates
`With a sealed interluminal chamber formed betWeen the
`enlarged thin Wall tubing and the housing. Each end of the
`housing eXtends beyond the enlarged thin Wall portion to
`engage the tubing along its outer diameter. The chamber
`may then be pressuriZed to a predetermined positive or
`negative value to promote compliance in the desired oper
`ating range.
`The present invention may also be used to provide an
`adjustable pressure regulator for supplying a static pressure
`to a pressure sensitive device Which is to be pressure
`regulated. The regulator includes a ?rst isolating chamber,
`With the chamber having a ?rst ?eXible diaphragm for
`separating a ?uid chamber having a ?uid to be pressure
`regulated from a ?rst liquid chamber. The regulator also
`includes a second isolating chamber, With the second cham
`ber having a second ?exible diaphragm for separating a
`second liquid chamber from a third chamber. A conduit
`connects the ?rst liquid chamber and the second liquid
`chamber to form an interconnected liquid column. A tubing
`member connects the ?uid to be pressure regulated to the
`?rst isolating chamber Whereby a static pressure is added to
`the ?uid to be pressure regulated by the static pressure of the
`liquid betWeen the ?rst and second diaphragms.
`The invention also includes an inline eXtracorporeal non
`invasive ?oW meter. The How meter includes a ?rst length of
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`unitary elastomeric tubing having a ?rst and second thin
`Wall portion de?ned therein, With a known ?oW resistance
`therebetWeen and ?rst and second pressure isolating cham
`bers surrounding the ?rst and second thin Wall portions
`respectively. Each of the ?rst and second pressure isolating
`chambers has a ?rst and second respective sampling ports
`de?ned therein Which are connected to a means for measur
`ing the pressure differential betWeen the ?rst and second
`sampling ports, Whereby the extracorporeal How may be
`calibrated from the measured pressure differential and the
`knoWn ?oW resistance.
`It is the objective of the present invention to modify,
`improve and provide a neW overall system that can be used
`to provide an adjustable pressure relief valve and a suction
`shut off valve, both of Which can be controlled With simple
`compact pressure/suction control device.
`A further objective of the present invention is to provide
`a neW overall system that provides the standard roller pump
`With the advantages of the centrifugal pump With the added
`advantages of enabling the user to adjust the maximum
`outlet pressure and minimum inlet pressure, each of Which
`can be controlled With a simple compact pressure/suction
`control device, at a signi?cant reduction in cost.
`It is also an objective of the present invention to modify,
`improve and provide a valve to accurately control resistance
`to blood How in an extracorporeal circulation.
`A further objective of the present invention is to form an
`extracorporeal circulation regulating valve Wherein it
`replaces standard shunts that are presently clamped (e.g.,
`arterio-venous or arterial ?lter shunt).
`A further objective of the present invention is to provide
`a pressure relief valve that provides easy visualization of
`both its closed and pressuriZed states.
`A further objective of the present invention is to provide
`a pressure relief valve With vibration or ?utter to act as an
`alarm. Alternately, the valve may be designed to eliminate
`?utter or vibration due to How through it.
`A further objective of the present invention is to provide
`a pressure relief valve that is blood compatible, that Will
`Withstand high internal pressures and that may be easily
`manufactured.
`Another objective of the present invention is to have a
`thermoplastic, extruded tubing for conventional roller
`pumps (peristaltic pumps) that incorporate inexpensive
`means to measure non invasively and/or control the pressure
`of pumped ?uid at the inlet and outlet of said pump and/or
`the How directed to the patient.
`Another objective of the present invention is to have a
`device that could be used to measure and control the
`minimum inlet and maximum outlet pressure of an extra
`corporeal pump Without additional risk of thrombosis
`present With current systems.
`Another objective of the present invention is to provide a
`single device Which Will facilitate noninvasive pressure
`measurements, provide pressure control and form a blood
`reservoir from a single length of standard extracorporeal
`tubing.
`Another objective of the present invention is to reduce the
`probability of clotting by increasing blood ?oW through the
`circuit, especially through the oxygenator When How to the
`patient is loW.
`Another objective of the present invention is to provide a
`device that Would limit the outlet or inlet pressure When used
`With a centrifugal pump. The device limits the recirculation
`of blood Within the pump that may occur at loW ?oW rates
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`and high pressures. This enables the system to recirculate the
`blood, reducing the exposure time of the blood to high shear
`Within the pump.
`Another objective of the present invention is to provide
`regulation of positive or negative pressure Within an extra
`corporeal circuit.
`A further objective of the present invention is to modify,
`improve and provide a How through (an inline) isolator
`betWeen the blood and pressure monitors and/or other
`devices that require blood pressure (negative or positive) to
`function and/or control Without cont