Methods for ultrafiltration control in hemodialysis

• US 5,725,776 A
• Filed: 03/01/1996
• Issued: 03/10/1998
• Est. Priority Date: 02/13/1995
• Status: Expired due to Term

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Aksys Ltd.
• Inventors: Treu, Dennis M., Kenley, Rodney S., Pawlak, Kenneth E., Brose, Tom L., Feldsein, Thomas M.
• Primary Examiner(s): KIM, SUN U
• Application Number:
  US08/560,334
• Time in Patent Office: 739 Days
• Field of Search: 210/645, 210/646, 210/739, 210/741, 210/805, 210/85, 210/90, 210/97, 210/137, 210/195.2, 210/929, 604/4, 604/5
• US Class Current: 210/646
• CPC Class Codes: A61L 2/04 Heat A61L2/08 takes precedence
• CPC Class Codes: A61L 2/18 Liquid substances or solutions comprising solids or dissolved gases
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1607 before use, i.e. upstream of dialyser
• CPC Class Codes: A61M 1/1609 after use, i.e. downstream of dialyser
• CPC Class Codes: A61M 1/1649 with pulsatile dialysis fluid flow
• CPC Class Codes: A61M 1/165 with a dialyser bypass on the dialysis fluid line
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/1658 Degasification
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• CPC Class Codes: A61M 1/1662 with heat exchange between fresh and used dialysate
• CPC Class Codes: A61M 1/1666 by dissolving solids
• CPC Class Codes: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/1672 using membrane filters, e.g. for sterilising the dialysate
• CPC Class Codes: A61M 1/1682 both machine and membrane module, i.e. also the module blood side
• CPC Class Codes: A61M 1/1684 Checking the module characteristics before reuse
• CPC Class Codes: A61M 1/1686 by heat
• CPC Class Codes: A61M 1/1688 with recirculation of the sterilising fluid
• CPC Class Codes: A61M 1/169 using chemical substances
• CPC Class Codes: A61M 1/1692 Detection of blood traces in dialysate
• CPC Class Codes: A61M 1/1694 : with recirculating dialysing liquid
• CPC Class Codes: A61M 1/288 : Priming priming in extracorporeal blood circuits A61M1/3643
• CPC Class Codes: A61M 1/3434 : with pre-dilution and post-dilution
• CPC Class Codes: A61M 1/3437 : downstream of the filter, e.g. post-dilution with filtrate
• CPC Class Codes: A61M 1/3465 : using dialysate as substitution fluid
• CPC Class Codes: A61M 1/3468 : using treated filtrate as substitution fluid
• CPC Class Codes: A61M 1/3609 : Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/3622 : with a cassette forming partially or totally the blood circuit
• CPC Class Codes: A61M 1/36224 : with sensing means or components thereof
• CPC Class Codes: A61M 1/36226 : Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/362263 : Details of incorporated filters
• CPC Class Codes: A61M 1/3626 : Gas bubble detectors
• CPC Class Codes: A61M 1/3627 : Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 1/3629 : degassing by changing pump speed, e.g. during priming
• CPC Class Codes: A61M 1/3639 : Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3641 : Pressure isolators
• CPC Class Codes: A61M 1/3643 : Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3644 : Mode of operation
• CPC Class Codes: A61M 1/3646 : Expelling the residual body fluid after use, e.g. back to the body
• CPC Class Codes: A61M 1/3647 : with recirculation of the priming solution
• CPC Class Codes: A61M 1/3649 : using dialysate as priming or rinsing liquid
• CPC Class Codes: A61M 1/365 : through membranes, e.g. by inverted trans-membrane pressure [TMP]
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/15 : Detection of leaks
• CPC Class Codes: A61M 2205/17 : with redundant control systems
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/3317 : Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 : PH measuring means
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3344 : Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3368 : Temperature
• CPC Class Codes: A61M 2205/3382 : Upper level detectors
• CPC Class Codes: A61M 2205/3386 : Low level detectors
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/6072 : Bar codes
• CPC Class Codes: A61M 2205/705 : Testing of filters for leaks blood in dialysate A61M1/1692
• CPC Class Codes: A61M 2205/707 : Testing of filters for clogging
• CPC Class Codes: A61M 2205/7554 : with means for unclogging or regenerating filters
• CPC Class Codes: A61M 2205/7581 : with means for switching over to a fresh filter on clogging or saturation
• CPC Class Codes: A61M 2206/11 : Laminar flow
• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity
• CPC Class Codes: A61M 39/16 : having provision for disinfection or sterilisation A61M39/143 takes precedence; methods or apparatus for disinfection or sterilisation A61L2/00
• CPC Class Codes: B01D 2311/04 : Specific process operations in the feed stream; Feed pretreatment
• CPC Class Codes: B01D 2311/10 : Temperature control
• CPC Class Codes: B01D 2311/25 : Recirculation, recycling or bypass, e.g. recirculation of concentrate into the feed
• CPC Class Codes: B01D 2311/2626 : Absorption or adsorption
• CPC Class Codes: B01D 2321/04 : Backflushing
• CPC Class Codes: B01D 2321/16 : Use of chemical agents
• CPC Class Codes: B01D 2321/32 : By heating or pyrolysis
• CPC Class Codes: B01D 61/02 : Reverse osmosis; Hyperfiltration ; Nanofiltration
• CPC Class Codes: B01D 61/025 : Reverse osmosis; Hyperfiltration
• CPC Class Codes: B01D 61/04 : Feed pretreatment
• CPC Class Codes: B01D 61/12 : Controlling or regulating
• CPC Class Codes: B01D 61/32 : Controlling or regulating
• CPC Class Codes: B01D 65/022 : Membrane sterilisation
• CPC Class Codes: B01D 65/102 : Detection of leaks in membranes
• CPC Class Codes: B01D 65/104 : Detection of leaks in membrane apparatus or modules
• CPC Class Codes: C02F 1/441 : by reverse osmosis
• CPC Class Codes: F16K 17/0453 : the member being a diaphragm
• CPC Class Codes: Y10S 210/929 : Hemoultrafiltrate volume measurement or control processes
• CPC Class Codes: Y10S 215/03 : Medical
• CPC Class Codes: Y10T 137/7722 : Line condition change responsive valves
• CPC Class Codes: Y10T 137/7794 : With relief valve
• CPC Class Codes: Y10T 137/7796 : Senses inlet pressure
• CPC Class Codes: Y10T 137/7799 : Liquid transfer

Abstract

Methods and apparatus for increasing the accuracy of ultrafiltration in a dialysis machine and decreasing the time required for dialysis. The machine inclused a substantially non-compliant tank for mixing and storing a batch of dialsyate. In a preferred form, the tank is a hollow vessel made from a lightweight and chemically inert material, such as polypropylene, reinforced on its exterior. The machine further includes an ultrafiltration pump for pumping fluid from an extracorporeal circuit to an ultrafiltration tank commensurate with the removal of water from the patient. The pump is calibrated with the volume of fluid in the tank. The reduction in the time to conduct hemodialysis of the patient is achieved by introducing the patient'"'"'s blood into the arterial line and conducting the blood to the blood pump, measuring the pressure of the blood in the arterial line, increasing the pump rate of the blood pump, and in the event that the pressure measured in the arterial line drops below a predetermined threshold value, slowing the pump rate of the blood pump.

Claims

1. A method for improving the control of ultrafiltration of a dialysis patient, comprising the steps of:

filling a substantially non-compliant tank with a batch preparation of dialysate, said tank comprising a cylindrical vessel made from polypropylene reinforced with fibers wound about the exterior surface of said tank;

pumping the dialysate through a dialysate circuit to a dialyzer;

conducting dialysis of the patient'"'"'s blood at said dialyzer;

pumping fluid from said dialysate circuit into an ultrafiltration tank;

whereby expansion of said substantially non-compliant tank is minimized, permitting accurate measurement of the fluids removed from the patient in said ultrafiltration tank.

2. The method of claim 1, wherein said dialyzer comprises a blood side and a dialysate side, the method further comprising the step of balancing the fluid pressure in said dialysate side and said blood side prior to conducting dialysis, thereby insuring that volumes of fluid removed from said dialysate circuit during ultrafiltration closely approximates the volume of fluid removed from said patient.

3. A method of increasing the accuracy of the removal of volumes of fluid from a patient during a dialysis session, said session having a predermined target of volume of fluid to be removed from the patient during the dialysis, said method performed in a dialysis machine having an ultrafiltration pump, a dialysate circuit and an ultrafiltration tank for receiving fluids from said dialysate circuit commensurate with the fluid removed from the patient, comprising the steps of:

prior to conducting dialysis of said patient,

(a) pumping dialysate through said dialysate circuit with said ultrafiltration pump, said dialysate circuit comprising a closed volume fluid circuit;

(b) measuring the flow rate of said dialysate with a flow meter in said dialysate circuit;

(c) calibrating said ultrafiltration pump from said measured flow rate; and

thereafter

conducting dialysis of said patient; and

during dialysis, pumping dialysate from said dialysate circuit with said ultrafiltration pump into said ultrafiltration tank in accordance with said predetermined target of volume of fluid to be removed from the patient.

4. The method of claim 3, wherein said method further comprises the steps of:

during said step of conducting dialysis, measuring the level of fluid in said ultrafiltration tank and comparing said measurements of fluid level with an expected volume of fluid in said ultrafiltration tank based on said target ultrafiltration volume, and

adjusting the pump rate of said ultrafiltration pump based on said comparison.

5. A method of increasing the accuracy of fluid removal from a patient during dialysis, said method performed in a dialysis machine having dialyzer, a dialysate circuit, an arterial line conducting blood from the patient to said dialyzer and a venous line conducting blond from said dialyzer back to said patient, comprising the steps of:

prior to dialysis,

(a) conducting blood from the patient into the blood side of said dialyzer;

(b) measuring the blood pressure in the inlet and outlet sides of said dialyzer;

(c) measuring the fluid pressure in the dialysate circuit;

(d) computing the average blood pressure in the dialyzer from said measured blood inlet pressure and said measured blood outlet pressure;

(e) comparing said average blood pressure with said measured pressure in said dialysate circuit; and

responsively

(f) adjusting the fluid pressure of said dialysate circuit to substantially match said average blood pressure;

wherein said step of adjusting the fluid pressure in said dialysate circuit comprises the step of;

pumping fluid between said ultrafiltration tank and said dialysate circuit, whereby pumping fluid from said ultrafiltration tank into said dialysate circuit increases the pressure in said dialysate circuit, and pumping dialysate from said dialysate circuit into said ultrafiltration tank decreases the pressure in said dialysate circuit;

and thereafter

pumping dialysate through the dialysate side of said dialyzer to dialyze the patient'"'"'s blood; and

pumping dialysate from said dialysate circuit into said ultrafiltration tank;

whereby the volume of fluid pumped into said ultrafiltration tank during dialysis closely approximates the volume of fluid removed from said patient due to the balance of pressure between said blood side and said dialysate side of said dialyzer.

6. The method of claim 5, wherein said tank is constructed of polypropylene reinforced with fibers wound on the exterior surface of said tank.

7. The method of claim 5, wherein the pump rate of said ultrafiltration pump is calibrated against a flowmeter in said dialysate circuit prior to the initiation of dialysis of said patient, so as to increase the accuracy of the ultrafiltration.

8. The method of claim 5, wherein said tank is constructed of polyvinylidene fluoride reinforced with fibers wound on the exterior surface of said tank.

9. A method of testing the integrity of an ultrafiltration system, said method performed in a dialysis machine having an ultrafiltration pump, a dialysate circuit comprising a closed fluid system and having a tank containing a batch of dialysate, and an ultrafiltration tank for receiving fluids from said dialysate circuit commensurate with the fluid removed from a dialysis patient, comprising the step of:

prior to dialysis,

(a) filling said dialysate circuit substantially completely with fluid;

(b) filling said ultrafiltration tank at least partially with fluid;

(c) pumping fluid from said ultrafiltration tank into said dialysate circuit;

(d) measuring the fluid pressure in said dialysate circuit in response to said pumping of fluid from said ultrafiltration tank into said dialysate circuit, the maintenance of an increase in pressure indicative of the integrity of said ultrafiltration system, and thereafter

conducting dialysis of said patient; and

pumping dialysate from said dialysate circuit into said ultrafiltration tank.

10. A method for improving the ultrafiltration control of a dialysis patient, comprising the steps of:

providing a volumetrically closed and substantially noncompliant dialysate circuit comprising a substantially noncompliant dialysate solution tank and a volumetrically closed dialysate flow path for circulation of a dialysate solution to a dialyzer having a blood side and a dialysate side;

providing an extracorporeal circuit for conducting blood from a patient to said blood side of said dialyzer and back to said patient, said blood creating a fluid pressure in said blood side of said dialyzer;

filling said dialysate solution tank and said dialysate flow path with said dialysate solution and circulating said dialysate solution through said dialysate circuit, said dialysate solution creating a fluid pressure in said dialysate side of said dialyzer;

providing an ultrafiltration pump in said dialysate circuit for removal of said dialysate solution from said dialysate circuit and calibrating said dialysate pump during said step of circulating said dialysate solution through said dialysate circuit;

immediately prior to commencing or terminating a dialysis session, balancing the fluid pressure in said dialysate side of said dialyzer with the fluid pressure in said blood side of said dialyzer by transferring fluid between an ultrafiltration tank and said dialysate circuit with said ultrafiltration pump to thereby raise or lower the pressure in said dialysate circuit;

during dialysis, removing a portion of said dialysate solution from said dialysate circuit in accordance with said ultrafiltration pump and storing said removed portion of said dialysate solution in said ultrafiltration tank.

11. The method of claim 10, further comprising the step of, prior to conducting dialysis, testing the integrity of said dialysate circuit by adding a quantity of fluid into said dialysate circuit after said dialysate circuit has been substantially filled with said dialysate solution and measuring the fluid pressure in said dialysate circuit, the maintenance of and increase in the fluid pressure indicative of the integrity of the dialysate circuit.