Dialysis apparatus for independently controlling the concentration of at least two ionic substances inside a patient's body

• US 6,325,774 B1
• Filed: 08/20/1998
• Issued: 12/04/2001
• Est. Priority Date: 08/21/1997
• Status: Expired due to Term

• Current Assignee: Industries Gambro
• Original Assignee: Hospal Industrie
• Inventors: Bene, Bernard, Burtin, Jacques
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Bianco, Patricia
• Application Number:
  US09/137,410
• Time in Patent Office: 1,202 Days
• Field of Search: 604/27, 604/4, 604/19, 604/21, 604/28, 604/29, 604/30, 604/31, 604/48, 604/500, 604/502, 604/503, 604/504, 604/505, 604/506, 604/507, 604/508, 604/93, 604/4.01, 604/5.01, 604/5.02, 604/5.04, 604/6.09, 604/6.11, 604/65-67, 210/739, 210/645, 210/646, 210/85, 210/87, 210/96.1, 210/103, 210/137, 210/321.65, 210/321.71, 210/929, 210/92.99, 128/692
• US Class Current: 604/4.01
• 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 1/165 with a dialyser bypass on the dialysis fluid line
• CPC Class Codes: A61M 1/3437 downstream of the filter, e.g. post-dilution with filtrate
• CPC Class Codes: A61M 1/3458 having electrolytes not present in the dialysate
• 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 2205/3393 by weighing the reservoir

Abstract

A dialysis apparatus includes a dialysis liquid circuit for circulating sodium chloride and sodium bicarbonate through a haemodialyser and a circuit for infusing a patient with at least one solution containing at least one ionic substance “A” absent from the dialysis liquid. The substance “A” has a determined concentration (A)sol in the infusion solution. A dialysance detector determines the actual dialysance “D” of the haemodialyser for sodium, and a flow rate detector determines the flow rate Qinf of infusion solution such that the concentration of the substance “A” inside the patient'"'"'s body tends towards a desired concentration (A)des, as a function of the dialysance “D”, the concentration (A)sol of the substance “A” in the infusion solution and the desired concentration (A)des, A regulator regulates the flow rate of infusion solution, and a controller drives the regulator to control the flow rate of the infusion solution such that this flow rate is substantially equal to the determined flow rate Qinf.

Claims

1. Dialysis apparatus comprising:

means for circulating a dialysis liquid containing sodium chloride and sodium bicarbonate through a haemodialyser;

means for infusing a patient with at least one solution containing at least one ionic substance A absent from the dialysis liquid, the substance A having a determined concentration (A)sol in the infusion solution;

means for measuring the conductivity of the dialysis liquid upstream and downstream of the haemodialyser;

means for calculating an actual dialysance D using at least two conductivity values (Cd1in, Cd1out, Cd2in, Cd2out) measured respectively upstream and downstream of the haemodialyser in at least two successively prepared dialysis liquids and using the formula;

$D=\frac{\mathrm{Qd}\times <br><br>\left(\mathrm{Cd1out}\right)-\mathrm{Cd1in})-\left(\mathrm{Cd2out}-\mathrm{Cd2in}\right)}{\mathrm{Cd2in}-\mathrm{Cd1in}}$

where Qd is the flow rate of dialysis liquid;

means for determining a flow rate Qinf of infusion solution such that the concentration of the substance A inside the patients body tends towards a desired concentration (A)des, as a function of the dialysance D, of the concentration (A)sol of the substance A in the infusion solution, and of the desired concentration (A)des;

regulating means for regulating the flow rate of infusion solution; and

control means for driving the means for regulating the flow rate of the infusion solution such that this flow rate is substantially equal to the determined flow rate Qinf.

2. Dialysis apparatus according to claim 1, wherein the means for determining the infusion flow rate Qinf comprise calculation means for calculating the infusion flow rate Qinf according to the formula:

$Q<br><br>\text{\hspace{1em}<br><br>}<br><br>\inf =\mathrm{Cl}\times <br><br>\frac{\left(A\right)<br><br>\mathrm{des}}{\left(A\right)<br><br>\mathrm{sol}-\left(A\right)<br><br>\mathrm{des}}$

where Cl is the clearance of the haemodialyser for the substance A, extrapolated on the basis of the dialysance D for sodium.

3. Dialysis apparatus according to claim 1, wherein the infusion solution contains sodium at a determined concentration (Na+)sol.

4. Dialysis apparatus according to claim 3, further including:

means for preparing the dialysis liquid, comprising means for regulating the sodium concentration of the dialysis liquid;

means for determining the sodium concentration (Na+)dial of the dialysis liquid such that the concentration inside the patient'"'"'s body tends towards a desired sodium concentration (Na+)des, as a function of the dialysance D, of the flow rate of the infusion liquid Qinf, of the sodium concentration (Na+)sol of the infusion solution, and of the desired sodium concentration (Na+)des; and

control means for driving the means for regulating the sodium concentration of the dialysis liquid such that this concentration is equal to the determined concentration (Na+)dial.

5. Apparatus according to claim 4, wherein the means for determining the sodium concentration (Na+)dial of the dialysis liquid comprises calculation means for calculating this concentration according to the formula:

$\left(\mathrm{Na}+\right)<br><br>\mathrm{dial}=\frac{Q<br><br>\text{\hspace{1em}<br><br>}<br><br>\inf }{D}<br><br>\left(\left(\mathrm{Na}+\right)<br><br>\mathrm{des}-\left(\mathrm{Na}+\right)<br><br>\mathrm{sol}\right)+\left(\mathrm{Na}+\right)<br><br>\mathrm{des}$

6. Apparatus according to claim 1, further including means for preparing a dialysis liquid from a first concentrated solution of sodium chloride and a second concentrated solution of sodium bicarbonate, these preparation means comprising means for regulating the sodium concentration and the bicarbonate concentration of the dialysis liquid independently of one another.

7. Apparatus according to claim 6, the means for preparing dialysis liquid comprise means for producing the first concentrated solution from sodium chloride in powder or granular form.

8. Apparatus according to claim 6, the means for preparing dialysis liquid comprise means for preparing the second concentrated solution from sodium bicarbonate in powder or granular form.

9. Apparatus according to claim 1, wherein the infusion means is designed to be connected to an extracorporeal blood circuit which includes the blood compartment of the haemodialyser, downstream of the haemodialyser.

10. Apparatus according to claim 1, wherein the substance A is selected from calcium, potassium and magnesium.

11. Dialysis apparatus comprising:

means for circulating a dialysis liquid containing sodium chloride and sodium bicarbonate through a haemodialyser;

means for infusing a patient with at least one solution containing at least one ionic substance A absent from the dialysis liquid, the substance A having a determined concentration (A)sol in the infusion solution, wherein the infusion solution contains sodium at a determined concentration (Na+)sol;

means for preparing the dialysis liquid, comprising means for regulating the sodium concentration of the dialysis liquid;

means for determining a sodium concentration (Na+)dial of the dialysis liquid such that a concentration inside a patient'"'"'s body tends towards a desired sodium concentration (Na+)des, as a function of a dialysance D, a flow rate of the infusion solution Qinf, the sodium concentration (Na+)sol of the infusion solution, and the desired sodium concentration (Na+)des, wherein the means for determining the sodium concentration employs the formula;

$\left(\mathrm{Na}+\right)<br><br>\mathrm{dial}=\frac{Q<br><br>\text{\hspace{1em}<br><br>}<br><br>\inf }{D}<br><br>\left(\left(\mathrm{Na}+\right)<br><br>\mathrm{des}-\left(\mathrm{Na}+\right)<br><br>\mathrm{sol}\right)+\left(\mathrm{Na}+\right)<br><br>\mathrm{des}$

means for driving the means for regulating the sodium concentration of the dialysis liquid such that this concentration is substantially equal to the determined concentration (Na+)dial;

means for determining an actual dialysance D of the haemodialyser for sodium;

means for determining a flow rate Qinf of infusion solution such that the concentration of the substance A inside the patient'"'"'s body tends towards a desired concentration (A)des, as a function of the dialysance D, of the concentration (A)sol of the substance A in the infusion solution, and of the desired concentration (A)des;

regulating means for regulating the flow rate of infusion solution; and

control means for driving the means for regulating the flow rate of the infusion solution such that this flow rate is substantially equal to the determined flow rate Qinf.