WO1994027658A1 - Apparatus and method for preventing hypotension in a dialysis patient - Google Patents

Apparatus and method for preventing hypotension in a dialysis patient Download PDF

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Publication number
WO1994027658A1
WO1994027658A1 PCT/US1994/006195 US9406195W WO9427658A1 WO 1994027658 A1 WO1994027658 A1 WO 1994027658A1 US 9406195 W US9406195 W US 9406195W WO 9427658 A1 WO9427658 A1 WO 9427658A1
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WO
WIPO (PCT)
Prior art keywords
sodium
patient
delivered
hemodialysis
concentration
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.)
Ceased
Application number
PCT/US1994/006195
Other languages
English (en)
French (fr)
Inventor
Prakash R. Keshaviah
Jian Ruan
James P. Ebben
David Luhring
Charles J. Dubauskas
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.)
Baxter International Inc
Original Assignee
Baxter International 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
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=22107393&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO1994027658(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Baxter International Inc filed Critical Baxter International Inc
Priority to BR9405391-0A priority Critical patent/BR9405391A/pt
Priority to CA002140521A priority patent/CA2140521C/en
Priority to DE69404805T priority patent/DE69404805T2/de
Priority to KR1019950700364A priority patent/KR100346348B1/ko
Priority to JP7501067A priority patent/JPH07509645A/ja
Priority to EP94919325A priority patent/EP0652780B1/en
Publication of WO1994027658A1 publication Critical patent/WO1994027658A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • 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
    • A61M1/1654—Dialysates therefor
    • A61M1/1656—Apparatus for preparing dialysates
    • 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
    • A61M1/1601—Control or regulation
    • A61M1/1603—Regulation parameters
    • A61M1/1605—Physical characteristics of the dialysate fluid

Definitions

  • the present invention relates generally to methods and apparatus for providing healthcare. More specifically, the present invention relates to methods and apparatus for treating patients via dialysis procedures.
  • Dialysis provides a method for supplementing or replacing renal function in certain patients. Dialysis is the process of separating elements in a solution by diffusion across a semipermeable membrane (diffusive solute transport) down a concentration gradient. Principally, hemodialysis and peritoneal dialysis are utilized. Although dialysis provides in many cases life saving therapy, there are health issues that must be addressed in such patients. In a typical hemodialysis system, blood is removed from the patient and pumped to a dialysis machine including a membrane unit. The membrane unit dialyzes the blood which is then returned to the patient through tubing. Hemodialysis machines may be used at a health facility or in the patient's home.
  • the machine attaches the patient through an extracorporeal circuit of blood tubing to a dialyzer having a pair of chambers separated by a thin semi-permeable membrane.
  • the patient's blood is circulated through one of the chambers.
  • the hemodialysis machine maintains a constant flow of a dialysate through the second chamber. Excess water from the blood is removed by ultrafiltration through the membrane and carried out by the dialysate to drain.
  • a typical hemodialysis machine provides a pair of hoses which connect to the dialyzer and includes a source of incoming water, a heat exchanger and heater for bringing the water to a required temperature, a source of a dialysate concentrate or concentrates which are introduced into the water in a predetermined concentration and necessary pumps, pressure regulators, a deaerator, flow controllers and regulators.
  • a source of incoming water a heat exchanger and heater for bringing the water to a required temperature
  • a source of a dialysate concentrate or concentrates which are introduced into the water in a predetermined concentration and necessary pumps
  • pressure regulators a deaerator
  • flow controllers and regulators In an acetate dialysis system, only one concentrate is utilized, while in the more common bicarbonate dialysis systems, two concentrates, acid and bicarbonate are utilized.
  • the dialysate delivery system mixes water, generally purified by reverse osmosis or deionization, with an electrolyte concentration so that it approximates the chemical composition of ECF, warms the blood to body temperature, and checks the conductivity to ensure it is isotonic to the patient's blood.
  • ECF electrolyte concentration
  • a number of commercially available machines are used to administer hemodialysis. Two such systems include the SPS 550 Delivery System and SPS 1550 Delivery System marketed by Baxter Healthcare, Deerfield, Illinois.
  • Membrane units come in different sizes with differing surface areas, clearance characteristics, and hydraulic coefficients for ultrafiltration. Instructions generally are given with respect to the specifications by the manufacturer. Usually hemodialysis treatments take three to five hours. Most patients with chronic renal failure require three weekly hemodialysis treatments to maintain a state of well being.
  • hypotension is usually due to a reduced blood volume consequent to fluid removable by ultrafiltration and the patient's inability to physiologically compensate for the reduced blood volume.
  • hypotensive dialysis patients are given hypertonic saline prophylactically via sterile injections to recruit fluid from the extravascular space to stabilize blood pressure. It is also common to give hypotensive dialysis patients hypertonic saline as a first recourse when hypotension is noted.
  • hypertonic saline typically, most hemodialysis units monitor, every half hour, the blood pressure of dialysis patients. When blood pressure begins to drop, a hypertonic saline solution is then administered. In other cases, isotonic saline is given, although the patients' weight loss goals must be increased to make up for the additional volume.
  • the present invention provides an automatic means and method for preventing and/or treating hypotension in hemodialysis patients.
  • a system is provided wherein the hemodialysis machine can automatically deliver sodium to the patient through the dialysate so as to increase blood and extracellular osmolarity, increase blood volume from vascular refilling, and raise blood pressure.
  • the sodium is delivered in response to a signal generated by the patient or other person. This would thereby alleviate any clinical symptoms caused by hypotension during hemodialysis.
  • the present invention provides a method for preventing hypotension in a patient receiving hemodialysis comprising the steps of automatically delivering to the patient, through the dialysate, sodium in response to a signal generated by the patient or healthcare personnel.
  • the signal is generated by the patient actuating a button on a controller extending from a hemodialysis machine.
  • the method includes the step of adjusting the concentration of sodium delivered over a predetermined period of time depending on other parameters.
  • the method includes the step of delivering a predetermined concentration of sodium in response to the signal, but, adjusting a length of time over which the sodium is delivered in response to other parameters.
  • the concentration of sodium to be delivered and the length of time over which the sodium is delivered is fixed.
  • the method includes the step of using hardware, at least in part to modify a typical hemodialysis machine so that it automatically delivers the sodium to the patient.
  • the method includes the step of using software, at least in part to modify a typical hemodialysis machine so that it automatically delivers the sodium to the patient.
  • the method includes the step of restricting the sodium delivered to the patient to a predetermined number of milliequivalents.
  • the method includes the steps of: entering into a delivery system, for delivering sodium to the dialysate, a patient's standard dialyzer clearance at a given blood and dialysate flow rate and the patient's sodium concentration and blood flow; calculating the mass transfer area coefficient for the dialyzer; and automatically, through the system, determining the total number of milliequivalents that will be required by the patient to prevent hypotension.
  • the present invention also provides a method for providing hemodialysis to a patient comprising the steps of: passing at least a portion of a patient's blood through a dialyzer that uses a dialysate to remove metabolic waste from the blood; and automatically adding an amount of sodium to the dialysate in response to a signal that may be generated by the patient or other personnel.
  • the present invention provides a hemodialysis system for providing hemodialysis to a patient comprising means for removing through the use of a dialysate, metabolic waste from a patient's blood stream, means for automatically adding to the dialysate an amount of sodium in response to a signal, and means for allowing the patient to generate the signal.
  • a hemodialysis machine that includes a dual variable proportioning pump.
  • An advantage of the present invention is that it provides an improved method and apparatus for hemodialysis.
  • an advantage of the present invention is that a consistent amount of sodium is administered to the patient.
  • an advantage of the present invention is that it reduces the staff requirements for a dialysis center.
  • an advantage of the present invention is that it provides a convenient method for administering an amount of sodium to a hemodialysis patient. Moreover, an advantage of the present invention is that it eliminates a number of the sterile disposables required for a dialysis center, e.g., needles, syringes, and sterile saline.
  • an advantage of the present invention is that it provides for the administration of sodium to a patient without the concomitant administration of fluid volumes.
  • an advantage of the present invention is that it provides sodium to the patient at an appropriate rate of delivery.
  • the present invention provides a method wherein the patient can automatically signal the apparatus to deliver the necessary sodium upon the onset of hypotensive symptoms.
  • Figure 1 illustrates schematically a hemodialysis system of the present invention.
  • Figure 2 illustrates an enlarged view of the means for generating a signal of the present invention.
  • Figure 3 illustrates, generally, a hardware oriented method for controlling a delivery system pursuant to the present invention.
  • Figure 4 illustrates hardware for modifying a typical hemodialysis machine to provide the system of the present invention.
  • Figure 5 illustrates a flow chart diagram of the control of sodium dosing through software, using proportioning pumps.
  • Figure 6 illustrates schematically, the interaction of the hardware, in response to the software of Figure 5.
  • Figure 7 illustrates how the software is implemented to respond to the signal generating means.
  • Figures 8-10 illustrate graphically the results of experiments set forth herein demonstrating the efficacy of the present invention.
  • the present invention provides a method and apparatus for automatically delivering sodium to a hemodialysis patient.
  • the sodium concentration in the dialysate is temporarily raised. This allows sodium to be delivered to the patient without the concomitant administration of fluid volumes.
  • the patient himself upon the onset of symptoms of hypotension, can signal the apparatus to increase the concentration of sodium.
  • others such as healthcare personnel can signal the apparatus to increase the concentration of sodium.
  • the apparatus will automatically dispense the appropriate concentration of sodium preventing the hypotensive episode. This thereby insures that the sodium is administered at the appropriate time and eliminates what is currently a very labor intensive procedure.
  • a hemodialysis machine 10 is illustrated. Any hemodialysis apparatus can be utilized with the present invention. It has been found that the present invention can be used satisfactorily with the SPS 550 Delivery System and SPS 1550 Delivery System available from Baxter Healthcare, Deerfield, Illinois.
  • Such a system e.g., the SPS 1550 Delivery System, includes a dual pump variable proportioning hemodialysis delivery system.
  • the sodium concentration can be changed in the resulting dialysis by varying the dilution ratio in both pumps. Pumps for achieving same are disclosed in U.S. Patent No. 5,158,441, the disclosure of which are incorporated herein by reference.
  • the pump can be a valveless positive displacement pump with a closed end cylinder having fluid inlet and outlet ports.
  • a piston is reciprocably and rotatably driven in the cylinder and includes a reduced area portion on one free end which communicates cyclically with the inlet and outlet ports to pump fluid through the positive displacement pump.
  • the piston also has a gland area formed in the piston which cyclically communicates with a pair of ports to clean the piston and cylinder and prevent the buildup of solids.
  • the angle between the drive shaft and the piston is adjustable to vary the fluid volume and aligned so that the end clearance between the piston and cylinder does not change as the angle is changed.
  • these pumps are utilized to provide short term on demand high sodium dialysate when, and if, needed by the patient to prevent hypotension.
  • Several factors influence the amount of sodium which is transported to the patient across the dialyzer membrane. These factors include the difference between the dialysate sodium and the patient's plasma water sodium. Additionally, the clearance of the dialyzer will influence the sodium transported to the patient. The clearance is influenced by the type of dialyzer, the blood flow rate, the dialysate flow rate, and the rate of ultrafiltration. Additionally, the amount of sodium which is transported will be influenced by a length of time the high sodium bolus persists.
  • each minute of dialysis flow is equivalent to 1 ml of 23.4% saline given by a sterile injection.
  • a patient were to receive a dose of 10 ml of hypertonic saline, the same dose could be given by 10 minutes of elevated dialysate sodium.
  • a standard delivery time and standard concentration elevation is internally set in the delivery system.
  • This can be done through the use of software.
  • the delivery of sodium is then activated by the patient when the patient feels symptoms associated with a hypotensive episode.
  • the patient presses a button on the activator that is attached to the delivery system.
  • the activator 12 is a palm sized pendant 14 including a button 16 which is attached to the delivery system by a cable 18.
  • the pendant includes a light 20 indicating activation of the system.
  • any means can be used for allowing the patient to activate the delivery.
  • a remote control which generates an infrared or other signal could be used if desired.
  • FIGS 3 and 4 illustrate generally a hardware oriented method used to control a hemodialysis delivery system, such as the SPS 1550, for purposes of elevating sodium by a fixed amount for a variable time.
  • the illustrated hardware can be implemented using software programmed into the hemodialysis system.
  • Figure 5 illustrates, generally, a flow diagram of the software used to deliver through a dual variable proportioning pump, sodium to the dialysate.
  • the software can be integrated in CPUs located in the hemodialysis machine.
  • the controller controls the mixing of the dialysate and thereby can add sodium thereto.
  • the monitor insures that the mixing is correct. By activating the button, the controller, through the software, will be caused to adjust the sodium level.
  • Figure 6 illustrates, generally, the interaction of the hardware of the hemodialysis with the software. Specifically, the ability of the hardware to increase the sodium added to the dialysate is illustrated.
  • Figure 7 illustrates how the software is implemented to respond to the button on the pendant that is actuated by the patient or healthcare personnel. The details of the implementation are as follows:
  • a noButtonAvail Button can NOT be used under present conditions.
  • the following State Transition Table defines all the transition paths between states. The table is grouped by exits from a particular state.
  • the system can be initially set to deliver a predetermined amount of sodium for a predetermined time in response to the signal.
  • the delivery time is adjustable while the sodium elevation is fixed. By providing the ability to change the delivery time, this will allow one to account for different dialyzers and/or different practices in different clinics. Again, the maximum total time of delivery will be controlled by limits programmed, stored and/or input in the software of the system, or hardware, to prevent sodium overdosing.
  • the delivery system can estimate the actual number of milliequivalents delivered to the patient.
  • the patient's standard dialyzer clearance (which is available from the manufacturer's specification) at the given blood flow and dialysate flow rates will be entered into the delivery system as part of the system set-up.
  • the patient's serum sodium concentration and blood flow will also be entered. Maximum sodium elevation can also be programmed.
  • the mass transfer area coefficient (MTAC) for the dialyzer can then be calculated from the entered data. This calculation is known in the art and can be performed through software.
  • the system then will calculate the delivery time that is necessary to yield the same sodium concentration as the unit's standard dose. Again, this calculation can be performed using software. In the calculation, it should be noted that since the theoretical dialyzer MTAC is generally higher than the actual whole body MTAC due to access recirculation, the MTAC used in the calculation will be adjusted downward by a standard percentage, for example 10%. Again, the system will operate as in the previous system by the patient, or other person, activating the delivery when the patient feels the symptoms indicating the onset of hypotension. By pressing a button, the delivery will be activated. The total number of meq of sodium delivered will be controlled by limits programmed in the software to prevent sodium overdosing.
  • the system is used with a double variable proportioning pump system
  • the system can also be utilized with a single pump system.
  • the elevation and concentration of non- sodium constituents would be higher than the corresponding elevations with the dual pump system.
  • EXAMPLE It is known to use hypertonic 23.4% sodium chloride solution for the prevention and management of hypotension and for the treatment of muscle cramps during hemodialysis.
  • a Baxter 1550 Delivery System with a dual proportioning system for preparing dialysate was modified, with the hardware illustrated in Figures 2 and 3, to allow for the automatic sodium delivery system of the present invention discussed above. Twelve patients who were enrolled in the study received typical hemodialysis with one exception - at those times when the patients would normally be given hypertonic 23.4% sodium chloride solution, the automated sodium delivery system was used to delivery a similar dose of sodium chloride to the patient.
  • Pre-dialysis samples were collected from the patient's hemodialysis access just prior to initiation of dialysis.
  • Post-dialysis samples were also collected from the patient's access at the conclusion of dialysis. Additionally, sample dialysis was collected pre- and post-dialyzer for sodium analysis during the time when the system was activated.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
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  • Engineering & Computer Science (AREA)
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  • Biomedical Technology (AREA)
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  • External Artificial Organs (AREA)
PCT/US1994/006195 1993-06-02 1994-06-01 Apparatus and method for preventing hypotension in a dialysis patient Ceased WO1994027658A1 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
BR9405391-0A BR9405391A (pt) 1993-06-02 1994-06-01 Processo para previnir hipotensão em paciente que recebe hemodiálise, processo e máquina para propiciar hemodiálise em paciente.
CA002140521A CA2140521C (en) 1993-06-02 1994-06-01 Apparatus and method for preventing hypotension in a dialysis patient
DE69404805T DE69404805T2 (de) 1993-06-02 1994-06-01 Vorrichtung zum vermeiden einer hypotonie bei dialysepatienten
KR1019950700364A KR100346348B1 (ko) 1993-06-02 1994-06-01 투석환자의저혈압을방지하는장치및방법
JP7501067A JPH07509645A (ja) 1993-06-02 1994-06-01 透析患者の低血圧を防止するための装置及び方法
EP94919325A EP0652780B1 (en) 1993-06-02 1994-06-01 Apparatus for preventing hypotension in a dialysis patient

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/072,413 1993-06-02
US08/072,413 US5346472A (en) 1993-06-02 1993-06-02 Apparatus and method for preventing hypotension in a dialysis patient

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WO1994027658A1 true WO1994027658A1 (en) 1994-12-08

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PCT/US1994/006195 Ceased WO1994027658A1 (en) 1993-06-02 1994-06-01 Apparatus and method for preventing hypotension in a dialysis patient

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US (1) US5346472A (https=)
EP (1) EP0652780B1 (https=)
JP (2) JPH07509645A (https=)
KR (1) KR100346348B1 (https=)
CN (1) CN1081933C (https=)
AT (1) ATE156369T1 (https=)
BR (1) BR9405391A (https=)
CA (1) CA2140521C (https=)
DE (1) DE69404805T2 (https=)
DK (1) DK0652780T3 (https=)
ES (1) ES2107840T3 (https=)
SG (1) SG48701A1 (https=)
TW (1) TW287109B (https=)
WO (1) WO1994027658A1 (https=)

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ATE156369T1 (de) 1997-08-15
CA2140521C (en) 1999-11-16
US5346472A (en) 1994-09-13
ES2107840T3 (es) 1997-12-01
SG48701A1 (en) 1998-05-18
TW287109B (https=) 1996-10-01
EP0652780A1 (en) 1995-05-17
BR9405391A (pt) 1999-09-08
KR100346348B1 (ko) 2002-12-28
DE69404805D1 (de) 1997-09-11
DE69404805T2 (de) 1998-03-19
KR950702440A (ko) 1995-07-29
JP2004358269A (ja) 2004-12-24
CA2140521A1 (en) 1994-12-08
CN1112776A (zh) 1995-11-29
DK0652780T3 (da) 1998-03-23
CN1081933C (zh) 2002-04-03
JPH07509645A (ja) 1995-10-26
EP0652780B1 (en) 1997-08-06

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