Method and apparatus for performing peritoneal dialysis

• US 5,141,492 A
• Filed: 05/29/1991
• Issued: 08/25/1992
• Est. Priority Date: 05/13/1991
• Status: Expired due to Fees

• Current Assignee: Medionics International, Inc. (Agarwal Hayashidera Holdings, Inc.)
• Original Assignee: Joseph E. Dadson, Mahesh Agarwal
• Inventors: Agarwal, Mahesh, Dadson, Joseph E.
• Primary Examiner(s): Wilson, John J.
• Assistant Examiner(s): Smith, Jeffrey A.
• Application Number:
  US07/707,025
• Time in Patent Office: 454 Days
• Field of Search: 604/27, 604/28, 604/29, 177/225, 177/174, 177/DIG. 6
• US Class Current: 604/28
• CPC Class Codes: A61M 1/1643 with weighing of fresh and used dialysis fluid
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/282 Operational modes
• CPC Class Codes: A61M 2205/3393 by weighing the reservoir

Abstract

An apparatus for carrying out peritoneal dialysis includes a central manifold, a receptacle for waste dialysate, means for supporting and heating a plurality of fresh dialysate bags, a first conduit connecting the manifold with the patient catheter, a second conduit for connecting the manifold with the receptacle, and a plurality of additional conduits connecting the manifold individually with a plurality of fresh dialysate bags. The individual conduits can be selectively closed by clamping means controlled by an electronic control, and the latter has an automatic mode which cycles the apparatus through (a) a fill/dwell phase in which the contents of one of the fresh dialysate bags flows into the patient'"'"'s peritoneum cavity by gravity and remains there, and (b) a drain phase which allows waste dialysate in the patient'"'"'s peritoneum cavity to drain by gravity into the receptacle. The steps (a) and (b) are repeated for all of the bags until they have been used up. A safety provision is provided to determine whether a sufficient quantity of dialysate has drained from the patient'"'"'s cavity during the drain phase. If not, the apparatus is shut down.

Claims

1. A method for carrying out peritoneal dialysis on a patient whose peritoneum cavity communicates with a patient catheter, the method comprising the steps:

a) providing an apparatus which includes

a manifold,

a receptacle for waste dialysate,

support means for supporting a plurality of fresh dialysate bags,

heating means for heating dialysate bags on said support means,

a first conduit for connecting the manifold with the patient catheter,

a second conduit for connecting said manifold with said receptacle,

at least two further conduits for connecting the manifold individually with a plurality of fresh dialysate bags, and

clamping means for selectively closing said conduits;

b) using electronic control means for controlling said clamping means in an automatic mode in which the control means causes the apparatus to cycle through the following phases;

1) a fill/dwell phase in which, for a first predetermined time, the first conduit and one of said at least two further conduits are both open while the remaining conduits are closed, whereby dialysate enters the patient'"'"'s peritoneum cavity by gravity and remains there, so long as the vertical level of the dialysate bags is above that of the patient, and

2) a drain phase in which, for a second predetermined time, the first and second conduits are both open while the remaining conduits are closed, whereby waste dialysate drains by gravity from the patient'"'"'s peritoneum cavity to said receptacle, so long as the vertical level of the patient is above that of the receptacle,

c) determining whether a sufficient quantity of dialysate has drained from the patient'"'"'s cavity during the drain phase, and passing such information to said electronic control means, the electronic control means being such as not to advance to the next fill/dwell phase if an insufficient quantity of dialysate has drained, and

d) repeating said steps

     1) and

     2) for another fresh dialysate bag, and so on until all such bags have been used.

2. The method claimed in claim 1, in which step c) is carried out by monitoring the weight of said receptacle and its contents.

3. An apparatus for carrying out peritoneal dialysis on a patient whose peritoneum cavity communicates with a patient catheter, the apparatus comprising:

(1) a manifold,

(2) a receptacle for waste dialysate,

(3) a plurality of fresh dialysate bags,

(4) support means supporting said plurality of fresh dialysate bags,

(5) heating means for heating said dialysate bags on said support means,

(6) a first conduit for connecting the manifold with the patient catheter,

(7) a second conduit for connecting said manifold with said receptacle,

(8) at least two further conduits connecting the manifold individually with each of said fresh dialysate bags,

(9) clamping means for selectively closing at least said second and said further conduits, and

(10) electronic control means for controlling said clamping means, the electronic control means having an automatic mode in which the control means causes the apparatus to cycle through the following phases;

a) a fill/dwell phase in which, for a first predetermined time, the first conduit and one of said at least two further conduits are both open while the remaining conduits are closed, thus allowing dialysate to enter the patient'"'"'s peritoneum cavity by gravity and remain there, so long as the vertical level of the dialysate bags is above that of the patient, and

b) a drain phase in which, for a second predetermined time, the first and second conduits are both open while the remaining conduits are closed, thus allowing waste dialysate to drain by gravity from the patient'"'"'s peritoneum cavity to said receptacle, so long as the vertical level of the patient is above that of the receptacle,

said steps a) and b) repeating for another fresh dialysate bag, and so on until all such bags have been used;

(11) safety means for determining whether a sufficient quantity of dialysate has drained from the patient'"'"'s peritoneum cavity during the drain phase, and for passing such information to said electronic control means, said electronic control means being such as not to advance to the next fill/dwell phase if an insufficient quantity of dialysate has drained, and

(12) selection means allowing a user to select the first and second predetermined times.

4. The apparatus claimed in claim 3, in which said safety means includes weighing means for weighing said receptacle and for supplying a signal when the weight of the receptacle exceeds a predetermined amount, and means for passing said signal to said electronic means, the apparatus further including:

(13) further selection means allowing the user to input the quantity of liquid in a fresh dialysate bag, said electronic control means being programmed to calculate, from such input, the amount of waste dialysate to expect from the patient during the drain phase.

5. The apparatus claimed in claim 4, further comprising:

a suspension means which includes a horizontally displaceable base portion, a first vertical post portion having a lower end and an upper end, said lower end being affixed to said base portion, a U-shaped intermediate portion secured to the upper end of said post portion, the U-shape having two arms and a bottom, the bottom of the U-shape being displaced laterally from said post portion, and a second vertical post portion fixed to said U-shaped portion in substantial vertical alignment with said first post portion, the second post portion supporting said support means, and

a control housing which contains said clamping means, said weighing means and said electronic control means, the housing being located within said U-shaped portion,

whereby the weights of all the components of the apparatus act generally along the common axis of the vertical post portions, thus permitting the base portion to have a minimal lateral extent.

6. The apparatus claimed in claim 3, further comprising:

a suspension means which includes a horizontally displaceable base portion, a first vertical post portion having a lower end and an upper end, said lower end being affixed to said base portion, a U-shaped intermediate portion secured to the upper end of said post portion, the U-shaped having two arms and a bottom, the bottom of the U-shape being displaced laterally from said post portion, and a second vertical post portion fixed to said U-shaped portion in substantially vertical alignment with said first post portion, the second post position supporting said support means,

a control unit housing said clamping means and said electronic control means, and being located within said U-shaped portion,

whereby the weights of all the components of the apparatus act generally along the common axis of the vertical post portions.

7. The apparatus claimed in claim 3, in which said safety means includes:

a hanger for suspending said receptacle,

a support means,

biasing means operatively interconnecting said hanger and said support means such that, as the receptacle increases in weight, the hanger descends with respect to said support means, and rack-and-pinion means operatively interconnected between said hanger and said support means and including a rack with teeth and a pinion with teeth, the rack teeth engaging the pinion teeth, whereby as the hanger descends the pinion rotates, and

electronic detection means for detecting rotation of said pinion and for transmitting to said electronic control means information based on such pinion rotation.

8. The apparatus claimed in claim 7, in which said biasing means includes a coil compression spring.

9. The apparatus claimed in claim 7, in which said hanger is a horizontal member, a vertical member connected to said horizontal member, a vertical member connected to said horizontal member at an intermediate location thereon and extending upwardly therefrom, a horizontal support connected to the vertical member adjacent the top of the latter, a coil compression spring surrounding the vertical member, the spring urging the horizontal support upwardly with respect to said support means;

and in which said pinion is mounted to said horizontal support for free rotation with respect thereto, such that the pinion moves vertically along with the horizontal support, the rack being fixed with respect to the support means.

10. The apparatus claimed in claim 3, in which the electronic control means further has a manual mode in which the electronic control means stops after each phase, and will not initiate a new phase until it receives a manual instruction to advance.