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WO2001008719A2 - Systemes de traitement hematologique fournissant une pression pulsatoire et procede d'utilisation - Google Patents

Systemes de traitement hematologique fournissant une pression pulsatoire et procede d'utilisation Download PDF

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Publication number
WO2001008719A2
WO2001008719A2 PCT/US2000/019609 US0019609W WO0108719A2 WO 2001008719 A2 WO2001008719 A2 WO 2001008719A2 US 0019609 W US0019609 W US 0019609W WO 0108719 A2 WO0108719 A2 WO 0108719A2
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WO
WIPO (PCT)
Prior art keywords
reservoir
blood
valve
pump
flow
Prior art date
Application number
PCT/US2000/019609
Other languages
English (en)
Other versions
WO2001008719A3 (fr
Inventor
Gerard Champsaur
Original Assignee
Sysflow Medical, Inc.
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 Sysflow Medical, Inc. filed Critical Sysflow Medical, Inc.
Priority to AU63539/00A priority Critical patent/AU6353900A/en
Publication of WO2001008719A2 publication Critical patent/WO2001008719A2/fr
Publication of WO2001008719A3 publication Critical patent/WO2001008719A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/104—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body
    • A61M60/109—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems
    • A61M60/113—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems in other functional devices, e.g. dialysers or heart-lung machines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/30—Medical purposes thereof other than the enhancement of the cardiac output
    • A61M60/36—Medical purposes thereof other than the enhancement of the cardiac output for specific blood treatment; for specific therapy
    • A61M60/37—Haemodialysis, haemofiltration or diafiltration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/424—Details relating to driving for positive displacement blood pumps
    • A61M60/438—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being mechanical
    • A61M60/441—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being mechanical generated by an electromotor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/538—Regulation using real-time blood pump operational parameter data, e.g. motor current
    • A61M60/554—Regulation using real-time blood pump operational parameter data, e.g. motor current of blood pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/845—Constructional details other than related to driving of extracorporeal blood pumps
    • A61M60/849—Disposable parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3334—Measuring or controlling the flow rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient

Definitions

  • the present invention relates to apparatus and methods for providing pulsatile flow in mass transfer units, such as hemodialysis and cardiopulmonary bypass machines, and collecting and reporting data generated during operation of such units.
  • Hemodialysis systems are known for cleansing blood of metabolites in patients having renal deficiency. Such systems typically involve flowing blood in contact with a first surface of a membrane or bundle and flowing a dialysate in contact with an opposing surface of the membrane or bundle, so that certain proteins and metabolites migrate from the blood across the membrane into the dialysate. Where equal pressures are used on either side of the membrane, the mass transfer effect is referred to as "hemodialysis " ; where the blood side pressure exceeds the dialysate pressure, the mass transfer effect is referred to as ''hemofiltration.”
  • U.S. Patent No.4.075,091 to Bellhouse describes a mass transfer unit having a corrugated mass transfer membrane that creates turbulence in the blood and dialysate flows adjacent to the membrane.
  • U.S. Patent No. 4,968.422 to Runge et al. describes a hemodialysis system that employs an external mechanism to cyclically compress a bladder-type chamber to enhance dialysis.
  • U.S. Patent No. 4.492.531 to Kenji et al. describes a system for use in hemodialysis that uses a standard roller pump, pressure absorbing bladder, and pinch- valve synchronized to the patient ' s EKG to induce pulse-like flow.
  • AV fistula arteriovenous fistula
  • an AV fistula typically is formed by providing an anastomosis of the radial artery to the cephalic vein. Over the course of several months, the venous limb of the fistula dilates and its walls thicken, permitting repeated insertion of dialysis needles.
  • the fistula When used as the vascular access site for dialysis over a period of years, however, the fistula gradually becomes obstructed, and may interfere with the efficacy of the dialysis treatment.
  • increased resistance to flow in the AV fistula may result in much less blood being filtered during a given dialysis session than might otherwise be expected based, for example, on roller-pump speed and session duration. This occurs because, in the absence of sufficient forward blood flow. the blood pump of the dialyzer will take up a percentage of the dialyzed blood entering the fistula via the venous needle, thereby recirculating the dialyzed blood and compromising the efficiency of the dialysis session.
  • parameters relevant to a dialysis session such as actual blood flow rate, resistance to flow in the AV fistula, volume of blood dialyzed, etc.. continuously or at selected points throughout a dialysis session, and which provide for that data to be transmitted to the care provider for review and evaluation.
  • a mass exchange system including a pump means providing simultaneous inlet and outlet displacement flow patterns which are independent of each other.
  • the pump of the present invention facilitates measurement of the flow rate and pressure of blood delivered by the pump to the patient, and permits computation of the resistance to blood flow in the patient ' s AV fistula.
  • key parameters relevant in assessing the therapeutic benefit of a dialysis session, may be continuously or intermittently monitored throughout a session. Detailed information regarding a patient ' s dialysis session is than stored and transmitted or made available to the patient ' s care provider for review and evaluation.
  • a dialysis system comprises a disposable time-varying pump assembly including first and second non-compliant reservoirs coupled to a valve wherein the valve is operable to cause the first reservoir to fill while the second reservoir is discharged and the first reservoir to discharge while the second reservoir is filled.
  • This assembly permits blood flow rate, pump outlet pressure, and flow resistance to be readily monitored.
  • non-compliant is intended to refer to a system that does not experience a substantial change in volume, i.e. less than 5% and preferably less than 1% with an increase in pressure expected during a normal pump stroke. Typical pressure excursions are about 200-750 mm Hg.
  • the pump assembly is coupled to a reusable drive system and controller that record and store data regarding relevant parameters, such as pump rate, resistance to flow, flow rate, instantaneous pressure and session duration for each dialysis session.
  • relevant parameters such as pump rate, resistance to flow, flow rate, instantaneous pressure and session duration for each dialysis session.
  • the data then may be processed and transmitted over a local area network, a wide area network, or both, to a computer available to a care provider for prompt review and evaluation.
  • the disposable pump assembly preferably includes an inlet port, an outlet port, first and second fluid reservoirs such as cylinders, and a valve that selectively interconnects the reservoirs to the inlet and outlet ports. Fluid in the cylinders is in direct contact with the piston faces to provide a system that is non-compliant whereby fluid flow can be easily and directly derived for each piston stroke.
  • the pump assembly may be coupled to a drive system and controller that optionally synchronizes operation of the valve and first and second reservoirs.
  • the valve is configured so that when the first reservoir is coupled to discharge through the outlet port, the second reservoir is coupled to fill from the inlet port, and blood is ejected or discharged from the first reservoir while the second reservoir recharges.
  • the flow pattern of blood entering the pump assembly and blood exiting the pump assembly may each by time-varying but independent of each other.
  • the flow pattern of the discharge side of the pump assembly may include a portion where the blood flow is reversed in direction, i.e. where there is backflow of blood into the pump assembly.
  • the pump assembly and drive system of the present invention preferably are configured to be used to retrofit pumps used in previously known dialysis, hemofiltration, and oxygenation systems, such as roller pumps, to reduce the capital cost of upgrading previously owned blood treatment systems.
  • FIG. 1 is a schematic view of an illustrative hemodialysis center using the apparatus of, and configured in accordance with the methods of. the present invention
  • FIG. 2 is a schematic view of a first embodiment of the dialysis system of the present invention
  • FIG. 3 is a schematic view of an alternative embodiment of the dialysis system of the present invention.
  • FIG. 4 is a schematic view of a hemodialysis system employing a pump constructed in accordance with the principles of the present invention
  • FIG. 5 is a side sectional view of the pump assembly and drive system of the present invention.
  • FIG. 6 is a partial exploded perspective view of the pump assembly of FIG. 5;
  • FIGS. 7A-7C are schematic side and plan sectional views of the pump assembly of FIG. 5 showing ejection of fluid from the upper cylinder;
  • FIGS. 8A-8C are schematic side and plan sectional views of the pump assembly of FIG. 5 showing ejection of fluid from the lower cylinder;
  • FIG. 9 is an exploded perspective view of an alternative embodiment of a valve constructed in accordance with the present invention.
  • FIGS. 10A and 10B are sectional views of the valve of FIG. 9 in the first and second positions; and
  • FIG. 11 is a graphic illustration of flow profile as a function of valve position and piston displacement.
  • the present invention relates generally to apparatus and methods for inducing time-varying or pulsatile flow in a mass transfer system, such as a hemodialysis, hemofiltration or blood oxygenation system, and for collecting, storing and transmitting data during use of such systems.
  • a disposable pump assembly and drive system are provided that enable key parameters, such as blood flow rate, pressure and resistance to flow in the patient's AV fistula, to be accurately computed and/or monitored during a dialysis session. These data may be stored and/or processed for later transmission to, and review and evaluation by. a care provider.
  • a fluctuating pressure wave-form is induced in blood flowing through the treatment unit, where the pressure wave-form mimics systolic flow.
  • the pressure fluctuations are expected to disrupt laminar flow fields within the dialysis or oxygenation unit, thereby enhancing mass transfer.
  • the systolic-like flow characteristics of blood returned to the patient will cyclically stretch the endothelium, thereby further enhancing mass transfer, as described, for example, in Champsaur. et al., "Flow-induced Release of Endothelium-derived Relaxing Factor During Pulsatile Bypass: Experimental Study in the Fetal Lamb, " J. Thoracic and Card. Surg., 114(5):739-745 (1997). Accordingly, the overall time that the patient must be connected to the treatment system is expected to be significantly reduced.
  • the apparatus includes a disposable pump assembly comprising a valve and two positive displacement constant-filling cylinders, and a reusable drive system and controller.
  • the apparatus further includes one or more sensors for monitoring the flow rate and pressure of blood leaving the pump assembly, and for computing resistance to flow encountered at the pump outlet.
  • the controller may be programmed to synchronize operation of the valve with the cylinders, and also optionally may synchronize operation of the system to the patient ' s heartbeat, for example, using a signal output from a pulse oximeter.
  • the pump assembly is arranged so that in a first position blood is ejected from the first cylinder while the other cylinder is recharged with blood, and in the second position, the first cylinder is recharged while the second cylinder ejects blood to the dialysis unit.
  • the use of two cylinders makes the pump '"constant filling * ', although there may be brief pauses or even backflow in the flow pattern of the pump assembly inlet.
  • the pump of the present invention therefore avoids the requirement of substantial intervals such as are required in previously known pulsatile pumps recharge, and during which there is no positive flow through the dialysis or oxygenation unit.
  • the pump assembly and drive system of the present invention may be readily adapted to retrofit pre-existing blood treatment systems.
  • Hemodialysis clinic is of the type where patients afflicted with renal disease make, on average, three visits per week to undergo dialysis, and comprises a plurality of booths in which patients may relax and read while undergoing dialysis.
  • Each dialysis system 12 comprises pump 13 and controller 14, as described in detail hereinafter.
  • Controllers 14 are coupled to server computer 15 via network 1 1 , for example, an Ethernet local area network.
  • Each of controllers 14 records and stores data throughout a patient ' s dialysis session, and in accordance with the methods of the present invention, enables that information to be provided to each patient ' s health care provider.
  • Controllers 14 preferably are programmed to compile and upload information for each patient ' s dialysis session to server computer 15 during or upon completion of each dialysis session.
  • Server computer 15 in turn may be programmed to transfer that information via a dial-up modem connection or dedicated line to server computer 16 of one or more health care providers via public standard telephone network 17.
  • Communication between server computer 15 and server computer 16 may be either by direct dial connection, or alternatively over a wide area network, such as the Internet.
  • a system configured as depicted in FIG. 1 therefore enables information critical to assessing the efficacy of a dialysis regime to be transmitted and made available to health care providers promptly upon completion of a dialysis session.
  • Pump 13 comprises positive displacement cylinders 20 coupled to multi-position valve 21 and drive system 22. and includes an inlet line 23 and return line 24. Pump 13 includes sensors, described below, and is controlled by, and provides relevant data to. controller 14. Controller 14 comprises microprocessor 25 coupled to ROM 26.
  • ROM 26 stores the microprocessor firmware
  • Storage device 28 also preferably stores programming for monitoring sensors incorporated in pump 13, and for analyzing that sensor data and uploading the relevant information to server computer 15 via NIC 29.
  • Input panel 30, e.g., a touch sensitive screen or keyboard, enables controller 14 to be selectively programmed to provide the desired treatment parameters, e.g., flow rate, etc., for a dialysis session.
  • Input panel 30 also permits data relevant to a patient, such as the patient ' s name or patient identifier number, pre- and post-dialysis weight, etc., to be input to the controller for purposes of tracking and transmitting data regarding the dialysis session.
  • Display 31 permits information input via input panel 30 to be verified, and also permits key parameters relevant to a dialysis session to be displayed, such as the pump flow rate, cumulative dialyzed volume, resistance to flow, temperature, pressure, duration of session, and the patient ' s name or patient identifier number.
  • controller 14 may be programmed to analyze and sample data collected during the course of a dialysis session, and process that data in a manner suitable for ready comprehension by the health care provider.
  • the controller 14 may be programmed to process or sample data collected throughout the dialysis session and render that information in graphical form or other forms that facilitate comprehension by the health care provider.
  • controller 14 also may be programmed to sound an alarm when critical parameters, such as blood flow rate, pressure and flow resistance encountered in the A-V fistula, exceed predetermined limits input via input panel 30.
  • Dialysis system 35 is similar to system 12 of FIGS. 1 and 2 and includes pump 13 and controller 14. Controller. 14 differs from that of FIG. 2, however, in that storage device 36 is substituted for NIC 29. In this case, controllers 14 are not coupled directly to network 1 1. Instead, removable items of media 37 are inserted into storage device 36 at the beginning of a dialysis session, and then removed upon completion of the session. Data stored on the removable media 37 mav then be transferred to a separate computer (not shown) for upload to server computer 15 and dispatch to server computer 16 of the health care provider.
  • Apparatus 40 includes a mass transfer or mass exchange unit such as dialysis unit 41, dialysate reservoir 42, dialysate pump 43. blood pump 44. controller 45, and pulse sensor 46.
  • Dialysis unit 41. reservoir 42 and pump 43 preferably comprise previously known devices, such as manufactured by Fresenius Medical Care, Bad Homburg, Germany, and are interconnected by suitable tubing 47, as is known in the art.
  • Dialysis unit 41 includes a membrane or filter bundle defining blood side 41a and dialysate side 41b.
  • Blood pump 44 is coupled to the patient and blood side 41a of dialysis unit 41 using suitable biocompatible tubing 48.
  • Tubing 48 includes inlet line 48a and outlet line 48b coupled to the patient ' s A-V fistula. Blood entering pump 44 from inlet line 48a is directed through blood side 41a of dialysis unit 41, and returned to the patient's A-V fistula via outlet line 48b.
  • Controller 45 controls operation of pump 44 so that blood returned to the patient has a pressure-wave-form- approximating that of the patient's blood pressure.
  • controller 45 may in addition comprise previously known pulse oximetry circuitry, and be coupled to pulse sensor 16 (e.g., a pulse oximeter sensor).
  • tubing 48 in addition may include a metered pump or drip line (nor shown) for infusing a small amount of antithrombogenic drug, such as heparin. into the blood passing through the dialysis unit to reduce the risk of clotting.
  • a metered pump or drip line not shown
  • Pump 44 comprises disposable pump assembly 50 (enclosed within the dotted line) removably coupled to reusable drive system 51.
  • Pump assembly 50 includes multi-position valve 52 coupled to cylinders 53 and 54.
  • Valve 52 includes inlet port 55 and outlet port 56 having pressure monitoring port 57 for measuring the pressure at the outlet of the pump 44.
  • Pressure monitoring port 57 may comprise, for example, an elastomer- covered window having a pressure transducer in contact therewith, and may be used to generate a signal corresponding to the pressure encountered at the pump outlet. from which resistance in the A-V fistula may be computed.
  • each of cylinders 53 and 54 includes piston 58 having O-ring 59 seated in a groove in the perimeter of the piston.
  • Rods 62 extend through openings 60 at the rear of each cylinder 53 and 54. and include arms 61 that are slidingly captured in grooves 63a of eccentric cams 63 (see FIG. 6).
  • Eccentric cams 63 are disposed on axle 64 of drive system 51 , so that axle 64 is driven by gearing 65 and motor 66 under the control of controller 14.
  • motor 66 may be coupled directly to axle 64. thus omitting gearing 65 and reducing the complexity of the device.
  • Eccentric cams 63 are 180° out of phase, so that when piston 53 is at its minimum stroke length (i.e.. in the charging position depicted in FIG. 5), cylinder 54 is at its maximum stroke length.
  • grooves 63a of cams 63 preferably are designed so that pistons 58 and rods 62 have a rapid stroke during an "ejection” or “discharge phase”, followed by a pause at the end of each ejection phase, and then a gradual retraction of the pistons during a "filling" or “recharge phase”, as determined by the shape of groove 63 a and the eccentricity of the cam. Inlet and outlet flow patterns can thus be controlled by the grooves. It is advantageously possible with this system to provide a certain amount of blood backflow during the outlet portion of each cycle.
  • an exemplary outlet flow is illustrated and described as segments A-F of a sequence of output flow pulses, each of which contains backflow. discharge and dwell phases.
  • the output pulse may contain some or all of these phases and may contain more than one of any phase.
  • the inlet flow is also illustrated in terms of pulses. However, in the preferred embodiement. the inlet or filling flow is as uniform as possible and the pulse is dominated by the charge phase. The pauses in inlet flow are required to accommodate the outlet pulse backflow phase and valve switching time. The length of the various phases is determined by the piston diplacement profile and the valve switch timing.
  • segment A Initiation of a cycle is represented as segment A.
  • piston 1 is fully extended into the cylinder (100% displacement) and piston 2 is fully retracted (0% displacement).
  • the valve is in position 1 , connecting cylinder 1 (piston 1 ) to the pump outlet.
  • Cylinder 2. (piston 2) is connected to the pump inlet.
  • Piston 1 is retracted while remaining connected to the pump outlet. This causes the negative outlet flow (backflow phase).
  • piston 2 remains stationary and inlet flow pauses.
  • valve is switched to position 2. connecting cylinder 2 (piston 2) to the pump outlet and cylinder 1 (piston 1 ) to the pump inlet.
  • piston 1 continues to be retracted, producing inlet flow (recharge phase).
  • Piston 2 is extended through its entire stroke, producing positive outlet flow (discharge phase).
  • piston 2 is fully extended into the cylinder (100% displacement) and piston 1 is fully retracted (0% displacement).
  • the valve remains in position 2. connecting cylinder 2 (piston 2) to the pump outlet. Cylinder 1, (piston 1) is connected to the pump inlet. Piston 2 is retracted while remaining connected to the pump outlet. This causes the outlet flow to reverse direction (backflow phase).
  • piston 1 remains stationary and inlet flow pauses.
  • valve is switched back to position 1 , connecting cylinder 1 (piston 1 ) to the pump outlet and cylinder 2 (piston 2) to the pump inlet.
  • piston 2 continues to be retracted, producing inlet flow (recharge phase).
  • Piston 1 is extended through its entire stroke, producing positive outlet flow (discharge phase).
  • the pumps may be digitally controlled linear pumps with the flow patterns being precisely controlled by a microcontroller.
  • drive system 51 also includes valve actuator motor
  • Valve actuator motor may comprise, for example, a stepper motor.
  • a preferred embodiment is described, in which cylinders 53 and 54 and housing 69 of valve 52 may be integrally formed using an injection molding process.
  • piece 70 includes one-half of the cylinders 53. 54 and valve housing 69.
  • another piece (not shown), which is the mirror-image of piece 70. is bonded (e.g.. by glue, ultrasonic energy or heat) to piece 70 after pistons 58 and valve body 68 are assembled between the halves.
  • controller 14 regulates the speed of motor 66 and operation of valve actuator motor 67 so that pistons 58 cause blood within the cylinders 53 and 54 to be expelled through outlet port 56 with a pressure wave-form that mimics systolic pressures within blood side 41a of dialysis unit 41.
  • Valve 52 includes valve body 68 rotatably disposed within housing 69.
  • Housing 69 preferably comprises a biocompatible material, and includes inlet port 55, outlet port 56, base 71. plenum 72, sidewall 73 and side ports 74 and 75.
  • Inlet port 55 is configured for connection to inlet line 48a.
  • Each of side ports 74 and 75 is coupled to a respective cylinder 53 and 54.
  • Sidewall 73 has a smooth inner surface, for example, coated with TEFLON*, i.e., polytetrafluoroethylene. for the reasons described hereinbelow.
  • Valve body 68 includes hub 76 that removably couples to valve actuator motor 67, and upper end 77 that seats in O-ring 78 and opens into plenum 72.
  • Valve body 68 includes longitudinal bore 79 that opens into plenum 72 and side members 80 and 81 having bores 82 and 83. respectively, that communicate with longitudinal bore 79.
  • valve body 68 When valve body 68 is disposed within housing 69. the outermost ends of side members 80 and 81 slide along the inner surface of sidewall 73. Side members 80 and 81 are circumferentially offset from one another so that when bore 82 of side member 80 is aligned with side port 74. bore 83 of side member 81 is sealed by the inner surface of sidewall 73. Conversely, when bore 83 of side member 81 is aligned with side port 75. bore 82 of side member 80 is sealed by the inner surface of sidewall 73. Accordingly, valve body 68 is configured so that blood is ejected from one of cylinders 53 and 54, the bore of the side member associated with the other cylinder is sealed, thus causing the blood to exit valve 52 via plenum 72 and outlet port 56.
  • valve 52 blood from inlet line 48a continuously flows through pump inlet port 55 and into annulus 85 defined by the exterior of valve bodv 68 and the inner surface of sidewall 73 of housing 69 (see FIGS. 5 and 6). Consequently, when one of side members 80 and 81 of valve body 68 is aligned with its respective side port 74 or 75, the other side member is moved clear of the other side port 74 or 75, allowing blood to pass from annulus 85 through that side port into the corresponding cylinder 53 or 54. Because one of side ports 74, 75 is always in communication with annulus 85 between the valve body and the housing, the design of pump assembly 50 ensures that one of the cylinders recharges with blood while blood is being expelled from the other cylinder.
  • valve body 68 is alternately rotated so each of cylinders 53 and 54 fills with blood from inlet line 48a through inlet port 55 and annulus 85.
  • Pulse sensor 46 then may be applied to the patient so that controller 45 may operate in synchrony with, or counter pulsation to. the patient ' s heart rhythm.
  • valve body 68 is rotated to a first position by valve actuator motor 67, responsive to controller 45, wherein side member 80 is coupled to cylinder 53 (FIG. 7B), and side member 81 is sealed against the inner surface of sidewall 73. Simultaneously, this movement of valve body 68 causes cylinder 54 to communicate with annulus 85 via side port 75, thereby permitting blood to charge cylinder 54 (FIG. 7C).
  • Motor 66 rotates axle 64 responsive to controller 45. causing eccentric cam 63 to push rod 62 of cylinder 53 to expel blood through side port 74, bore 82, longitudinal bore 79 and outlet port 56 to blood side 41a of dialysis unit 41 (FIG. 7A), while at the same time retracting piston 58 of cylinder 54 to permit that cylinder to recharge with blood.
  • Controller 45 then causes valve actuator motor 67 to rotate valve body 68 to a second position, shown in FIG. 8A, in which side member 80 is sealed against the inner surface of sidewall 73 (FIG. 8B) and side member 81 is coupled to cylinder 54 via side port 75 (FIG. 8C). In this position side port 74 of cylinder 53 communicates with annulus 85. thus causing cylinder 53 to recharge.
  • controller 45 again signals valve actuator motor 67 to return valve body 68 to the first position, so that blood is expelled from cylinder 53 while cylinder 54 recharges with blood. Controller 45 thereafter cycles valve body 68 between the first and second positions to alternately expel blood from cylinders 53 and 54. respectively.
  • blood pump 44 provides all of the data needed to continuously monitor the resistance to flow encountered during perfusion of dialyzed blood into the patient's AV-fistula. These key parameters then may be stored and transmitted to the health care provider using the network configurations of FIGS. 1-3, thus providing the capability for prompt evaluation of the efficacy of a patient's dialysis session.
  • Valve 90 includes valve body 91 disposed for sliding movement within housing 92.
  • Housing 92 preferably comprises a biocompatible material, and includes base 93, lid 94, sidewall 95, inlet port 96 and side ports 97 and 98.
  • Inlet port 96 is configured for connection to inlet line 48a.
  • Side ports 97 and 98 are coupled to cylinders 53 and 54, for example, as part of an integrally molded piece, as described hereinabove with respect to FIG. 6.
  • Sidewall 95 has a smooth inner surface, for example, coated with polytetrafluoroethy lene (TEFLON*) .
  • TEFLON* polytetrafluoroethy lene
  • Valve body 91 includes rod 100 that extends through aperture 101 of base 93, and spring 102 that biases valve body 91 in direction D. Valve body 91 also includes portion 103 that projects through lid 94 to engage with valve actuator motor 67 (see FIG. 5). Valve body 91 includes longitudinal blind bore 104 that extends through portion 103 to form outlet port 105, and side members 106 and 107 having bores 108 and 109, respectively, that communicate with longitudinal bore 104.
  • valve body 91 When valve body 91 is disposed within housing 92. the outermost ends of side members 106 and 107 slide along the inner surface of sidewall 95. Side members 106 and 107 are spaced apart longitudinally from one another so that when bore 108 of side member 106 is aligned with side port 97. bore 109 of side member 107 is sealed by the inner surface of sidewall 95. Conversely, when bore 109 of side member 107 is aligned with side port 98, bore 108 of side member 97 is sealed by the inner surface of sidewall 95. Accordingly, valve body 91 is configured so that blood is ejected from one of cylinders 53, the bore of the side member associated with the other cylinder is sealed, thus causing the blood to exit valve 90 via outlet port 105.
  • valve 90 blood from inlet line 48a continuously flows through pump inlet port 96 and into annulus 1 10 defined by the exterior of valve body 91 and the inner surface of sidewall 95 of housing 92 (see FIGS. 10A and 10B). Consequently, when one of side members 106 and 107 of valve body 91 is aligned with its respective side port 97 or 98, the other side member is moved clear of the other side port 97 or 98, allowing blood to pass from annulus 110 through that side port into the corresponding cylinder 53 or 54. Because one of side ports 97, 98 is always in communication with annulus 1 10 between the valve body and the housing, the one of the cylinders recharges with blood while blood is being expelled from the other cylinder.
  • Portion 103 of valve body 91 preferably is coupled to valve actuator motor 67, such as a stepper motor, through suitable gearing that slides valve body 91 between a first position, wherein cylinder 53 is coupled to outlet port 105, and a second position, wherein cylinder 54 is coupled to outlet port 105.
  • valve actuator motor 67 moves valve body 91 responsive to signals generated by controller 45
  • portion 103 may include rack gear 11 1 adapted to be interengaged with a pinion ring of the stepper motor.
  • portion 103 may be coupled to valve actuator motor 67 by other suitable means, such as a linear actuator. Referring to FIGS. 10A and 10B, operation of blood pump 44 employing valve 90 is described.
  • valve body 91 is alternately moved so each of cylinders 53 and 54 fills with blood from inlet line 48a through inlet port 96 and annulus 1 10.
  • Valve body 91 then is pulled in direction C by valve actuator motor 67 to a first position wherein side member 106 is coupled to cylinder 53 (FIG. 10A). and side member 107 is sealed against the inner surface of sidewall 95.
  • Controller 45 also causes motor 66 to rotate axle 64, which operates the piston of cylinder 53 to expel blood through side port 97 to blood side 41a of dialysis unit 11, while simultaneously causing the piston of cylinder 54 to retract.
  • controller 45 causes valve actuator motor 67 to rotate valve body 91 to a second position wherein side member 106 is sealed against the inner surface of sidewall 95 and side member 107 is coupled to cylinder 54 (FIG. 10B).
  • This movement of valve body 91 also enables annulus 1 10 to communicate with cylinder 53 via side port 97.
  • axle 64 and eccentric cams 63 causes piston 58 of cylinder 54 to expel blood through side port 98, bore 104 and outlet port 105 to blood side 41a of dialysis unit 41, while causing piston 58 of cylinder 53 to retract and draw blood from annulus 1 10 into cylinder 53.
  • valve 52 of FIG. 5 because valve 90 permits one cylinder to be actuated while the other cylinder recharges, there is no time lag associated with recharging the cylinders, as encountered with previously known pulsatile blood pumps.
  • blood pump 44 preferably is designed to permit it to be retrofitted to previously known dialysis machines. Applicant expects that the pulsatile flow provided by the constant filling pump of the present invention may significantly reduce dialysis session times by enhancing mass transfer in the dialysis unit and enhancing the release of endothelial factors by cyclically stretching the patient ' s endothelium. as described hereinabove.
  • pump 44 of the present invention advantageously may be substituted for roller pump 43 of FIG. 4, thereby further enhancing mass transfer in dialysis unit 41 by providing pulsatile flow on both sides of the system.
  • CPB machines cardiopulmonary bypass machines
  • Previously known CPB machines also may benefit from disruption of laminar flow around the hollow fiber bundles used in such machines, and the pulsatile flow generated by the pump of the present invention also may provide benefits with respect to stretching the endothelium to enhance release of endothelial factors.
  • a pump constructed in accordance with the principles of the present invention is expected to provide higher flow rates than previously known pulsatile pumps. This advantage is expected to be particularly beneficial in the context of blood oxygenation. Because the pump of the present invention will enable the use of smaller oxygenators that require a lower priming volume. In addition, the pump of the present invention may facilitate heat transfer in heat exchanger applications.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Mechanical Engineering (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Urology & Nephrology (AREA)
  • External Artificial Organs (AREA)

Abstract

La présente invention concerne un appareil et des procédés d'utilisation de systèmes de traitement hématologique par transfert de masse, tels que les unités d'hémodialyse, d'hémofiltration ou d'oxygénation du sang. Cet appareil comprend une pompe qui possède un orifice d'entrée, un orifice de sortie, un premier et un second réservoir, une vanne qui sélectivement interconnecte les réservoirs aux orifices d'entrée et de sortie. Un contrôleur synchronise le fonctionnement de cette vanne, du premier et du second réservoir de façon à obtenir simultanément des plans de flux de déplacement d'entrée ou de sortie indépendants l'un de l'autre. Cet appareil peut aussi être mis en oeuvre dans une configuration en réseau afin de permettre de télécharger des paramètres clé relatifs à une séance de traitement d'un patient avec cette unité de traitement hématologique, chez un fournisseur de service santé afin d'obtenir une évaluation rapide.
PCT/US2000/019609 1999-07-29 2000-07-18 Systemes de traitement hematologique fournissant une pression pulsatoire et procede d'utilisation WO2001008719A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU63539/00A AU6353900A (en) 1999-07-29 2000-07-18 Blood treatment system providing pulsatile flow and method of use

Applications Claiming Priority (2)

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US36461999A 1999-07-29 1999-07-29
US09/364,619 1999-07-29

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WO2001008719A2 true WO2001008719A2 (fr) 2001-02-08
WO2001008719A3 WO2001008719A3 (fr) 2008-02-28

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7172570B2 (en) 2003-01-28 2007-02-06 Gambro Lundia Ab Apparatus and method for monitoring a vascular access of a patient subjected to an extracorporeal blood treatment
DE102008015387A1 (de) * 2008-03-20 2009-09-24 Sartorius Stedim Biotech Gmbh Vorsterilisierbares Filtrationssystem zum Einmalgebrauch
US7794419B2 (en) 2005-05-18 2010-09-14 Gambro Lundia Ab Apparatus for controlling blood flow in an extracorporeal circuit
US7896831B2 (en) 1998-10-23 2011-03-01 Gambro Lundia Ab Method and apparatus for calculating fluid flow rate
CN115845247A (zh) * 2022-12-20 2023-03-28 上海炫脉医疗科技有限公司 一种可持续冲洗血泵的清洗系统

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3811800A (en) * 1972-07-12 1974-05-21 K Shill Blood pump
US4568249A (en) * 1983-08-26 1986-02-04 Todd James W Variable reciprocating plunger pump
WO1995028185A1 (fr) * 1994-04-15 1995-10-26 Allegheny-Singer Research Institute Hematopompe et son procede de fabrication
JPH08210248A (ja) * 1994-10-31 1996-08-20 Harry Ono 複式ピストン・ポンプ
US5685698A (en) * 1996-07-30 1997-11-11 Smoll; Owen Clark Method and apparatus for a pulsatile blood pump with no hemolysis

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7896831B2 (en) 1998-10-23 2011-03-01 Gambro Lundia Ab Method and apparatus for calculating fluid flow rate
US7955291B2 (en) 1998-10-23 2011-06-07 Gambro Lundia Ab Method and apparatus for detecting access recirculation
US7172570B2 (en) 2003-01-28 2007-02-06 Gambro Lundia Ab Apparatus and method for monitoring a vascular access of a patient subjected to an extracorporeal blood treatment
US7794419B2 (en) 2005-05-18 2010-09-14 Gambro Lundia Ab Apparatus for controlling blood flow in an extracorporeal circuit
DE102008015387A1 (de) * 2008-03-20 2009-09-24 Sartorius Stedim Biotech Gmbh Vorsterilisierbares Filtrationssystem zum Einmalgebrauch
DE102008015387B4 (de) 2008-03-20 2019-01-10 Sartorius Stedim Biotech Gmbh Vorsterilisierbares Filtrationssystem zum Einmalgebrauch
US10766003B2 (en) 2008-03-20 2020-09-08 Sartorius Stedim Biotech Gmbh Presterilizable filtration system to be disposed of after a single use
CN115845247A (zh) * 2022-12-20 2023-03-28 上海炫脉医疗科技有限公司 一种可持续冲洗血泵的清洗系统

Also Published As

Publication number Publication date
AU6353900A (en) 2001-02-19
WO2001008719A3 (fr) 2008-02-28

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