Method and apparatus for performing peritoneal dialysis

• US 6,228,047 B1
• Filed: 12/21/1999
• Issued: 05/08/2001
• Est. Priority Date: 07/28/1997
• Status: Expired due to Term

• Current Assignee: Newsol Technologies Incorporated
• Original Assignee: 1274515 Ontario Inc.
• Inventors: Dadson, Joseph E.
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): Hayes, Michael J.
• Application Number:
  US09/468,586
• Time in Patent Office: 504 Days
• Field of Search: 604/27, 604/29-34, 604/89, 604/91, 604/131, 604/407, 137/625, 137/625.11, 137/627.5, 137/625.67
• US Class Current: 604/29
• CPC Class Codes: A61M 1/1524 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: A61M 1/1561 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/159 specially adapted for peritoneal dialysis
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/167 Flexible packaging for solid concentrates
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/281 Instillation other than by gravity
• CPC Class Codes: A61M 1/284 Continuous flow peritoneal dialysis [CFPD]
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3351 Controlling upstream pump pressure
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/583 by visual feedback

Abstract

An automated peritoneal dialysis machine is provided which is capable of selecting and changing the composition of dialysate delivered to a patient in the course of treatment to meet specific physiological needs. The apparatus includes means for metering solutions of osmotic agent, electrolytes and other desired dialysate components from separate solution containers into mixing chamber means for combination in desired proportions. The means for delivery of fresh dialysis fluid to a patient and for removing spent dialysis fluid from the patient includes means for monitoring intraperitoneal pressure and other conditions of the fluid in the peritoneum and electronic control means responsible to the signal of monitoring means for controlling rates of dialysate infusion and removal.

Claims

1. Apparatus for carrying out peritoneal dialysis on a patient whose peritoneal cavity is in communication with at least one patient catheter, said apparatus comprising:

(a) a manifold comprising a plurality of liquid input/output ports;

(b) occlusion means for selectively sealing off and re-opening communication between any one or more of said input/output ports and the other input/output ports of the manifold;

(c) a patient conduit line for connecting at least a second one of said input/output ports to said patient catheter;

(d) conduit lines for connecting others of said input/output ports to respective container bags of dialysate solution components; and

(e) metering means in communication with at least a first one of said input/output ports, operable to withdraw and measure volume of a selected quantity of liquid from said manifold and to allow the mixing together of selected quantities of components of said dialysate solution to provide a dialysis solution of a desired final formulation; and

(f) electronic control and sequencing means for controlling said occlusion means and said metering means, operable to cause the selected volume of each of selected ones of said components to be withdrawn by said metering means and further operable to cause a selected volume of said dialysis solution of a desired final formulation to be injected through said patient conduit line into a peritoneal cavity line of the patient in a FILL phase and, after a first selected time in a DWELL phase, to be withdrawn from the peritoneal cavity into said metering means.

2. Apparatus according to claim 1, further comprising a drain conduit line for connecting a third one of said input/output ports to a receptacle for spent dialysate, said electronic control and sequencing means being operable in a DRIN phase following said first selected time to cause all or part of the spent dialysis solution withdrawn into said metering means to be injected through said drain conduit line into said receptacle.

3. Apparatus according to claim 1, wherein said metering means comprises fluid transfer means including a pumping mechanism and reservoir means of calibrated variable volume, and electromechanical drive means operable to vary the volume of said reservoir means in a program of stepped increases or decreases of said calibrated volume in response to control signals from said electronic control and sequencing means.

4. Apparatus according to claim 3, wherein said metering means comprises a syringe pump having a syringe plunger and electromechanical drive means for stepped advancement or retraction of said syringe plunger in response to control signals from said electronic control and sequencing means, for producing selected fixed or variable fluid proportioning ratios.

5. Apparatus according to claim 4, wherein said manifold, said occlusion means and said syringe pump are housed within an integral cartridge assembly.

6. Apparatus according to claim 5, further including pre-sterilized container bags of dialysate solution in operative connection to said manifold.

7. Apparatus according to claim 2, further comprising means for monitoring the intraperitoneal pressure of the patient and producing a first monitoring signal to said electronic control and sequencing means for use in determining and implementing operation steps of the apparatus appropriate to desired therapeutic treatment of the patient.

8. Apparatus according to claim 7, wherein said operation steps of the apparatus are for the determination or control of ultrafiltration during dialysis treatment of a patient.

9. Apparatus according to claim 7, wherein said operation steps are appropriate to determine elasticity or ageing of the peritoneal membrane of a patient undergoing peritoneal dialysis.

10. Apparatus according to claim 2, further comprising electro-optical means for producing a second monitoring signal to said electronic control and sequencing means, said second monitoring signal being indicative of turbidity of fluid in said patient conduit line at a selected time, for use in determining and implementing operations of the apparatus appropriate to desired therapeutic treatment of the patient.

11. A method for carrying out peritoneal dialysis on a patient whose peritoneal cavity is in communication with at least one patient catheter, said method comprising the step of maintaining liquid pressure in the peritoneal cavity at a selected value during a DWELL phase, by removing excess liquid from, or injection additional dialysate solution into the peritoneal cavity, in response to changes in the peritoneal cavity liquid pressure, and determining ultrafiltration during said DWELL phase from measurements of the excess liquid removed or the additional dialysate solution injected.

19. The method of claim 11, wherein during said DWELL phase, a selected quantity of dialysis fluid is withdrawn from the peritoneal cavity and returned to the peritoneal cavity a selected number of times in order to agitate and homogenize the fluid.

12. A method for carrying out peritoneal dialysis on a patient whose peritoneal cavity communicates with at least one patient catheter, the method comprising the steps of:

(a) providing an apparatus which includes

a manifold with a plurality of liquid input/output ports,

occlusion means for selectively sealing off and re-opening communication between any one or more of said input/output ports and the other input/output ports of said manifold,

metering means in communication with at least a first one of said input/output ports, operable to withdraw and measure a volume of selected quantities of liquid from said manifold and to inject selected volumes of liquid into said manifold,

means for injecting selected volumes of liquid from said manifold into a mixing chamber;

a patient conduit line for connecting at least a second one of said input/output ports to said patient catheter, and

conduit lines for connecting others of said input/output ports to respective container bags of dialysate solution components;

(b) using electronic control and sequencing means, operable to control operation of said occlusion means and metering means, in conjunction with sensor means operable to convey monitoring signals to said electronic control and sequencing means indicative of a condition of liquid in the peritoneal cavity of the patient, in an automatic mode in which said control and sequencing means causes

(i) a selected volume of each of selected ones of said dialysate solution components to be withdrawn by said metering means to provide a dialysis solution in said mixing chamber of any desired final composition or formulation,

(ii) a selected volume of said dialysis solution to be subsequently injected through said patient conduit into the peritoneal cavity in a FILL phase and,

(iii) after a selected dwell time during a DWELL phase at least a portion of spent dialysis solution to be withdrawn from the peritoneal cavity into said metering means.

13. A method according to claim 12, wherein said selected dwell time is determined by monitoring signals received by said electronic control and sequencing means.

14. A method according to claim 12, wherein said apparatus provided to carry out the method further includes a drain conduit line for connecting a third one of said input/output ports to a receptacle for spent dialysate, and wherein said electronic control and sequencing means is used in a DRAIN phase following said selected dwell time to cause the apparatus to withdraw all or part of the spent dialysis solution into said metering means and to be injected through said drain conduit line into said receptacle.

15. A method according to claim 14, wherein said sensor means comprises pressure transducer means operable to produce a monitoring signal indicative of intraperitoneal pressure in the patient.

16. A method according to claim 14, wherein said sensor means comprises electro-optical means for producing a monitor signal indicative of turbidity of fluid in said patient conduit line.

17. A method according to claim 15, wherein said automatic mode of operation includes maintaining liquid pressure in the peritoneal cavity at a selected value by causing the apparatus to remove excess solution from, or inject additional dialysate solution into the peritoneal cavity, in response to the monitoring signals from said pressure transducer means.

18. A method according to claim 17, further comprising the step of measuring as a function of time volume of excess solution removed from the peritoneal cavity of the patient to maintain substantially constant intraperitoneal pressure to characterize transport characteristics of a peritoneal membrane of a patient being treated.