Portable peritoneal dialysis cycler

• US 5,445,610 A
• Filed: 01/15/1993
• Issued: 08/29/1995
• Est. Priority Date: 01/15/1993
• Status: Expired due to Fees

• Current Assignee: University of Cincinnati
• Original Assignee: University of Cincinnati
• Inventors: Evert, Carl F.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/005,904
• Time in Patent Office: 956 Days
• Field of Search: 604/65, 604/80-81, 604/246, 604/4-6, 604/27-29, 604/33-34, 604/249-250, 604/83, 604/174, 604/283, 604/410
• US Class Current: 604/29
• 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
• CPC Class Codes: A61M 2209/082 Mounting brackets, arm supports for equipment

Abstract

A portable, gravity-type peritoneal dialysis cycler for controlling during each dialysis cycle the volumetric flows of an exchange fluid into and out of the peritoneal space of a patient, and the dwell time of the exchange fluid therein. The cycler comprises an easily assembled vertical stand supporting a load cell from which a pair of exchange fluid filled bags are suspended above the level of the patient'"'"'s peritoneal space and a pair of drain bags are suspended therebelow. The single load cell is connected to an electronic scale circuit. A single tube is connected at one end to a surgically implanted catheter leading to the patient'"'"'s peritoneal space, and at its other end to a "Y" fitting connected to a tube assembly from the exchange fluid bags and to a tube assembly leading to the drain bags. The fluid exchange bag and the drain bag tube assemblies are easily inserted into and controlled by zero loading force, normally closed, solenoid control valves. A laptop microcomputer serves as a controller to convert differential weights into volumes, activate the control valves, time the fill, dwell and drain portions of each cycle, detect and alarm malfunctions, and record all patient information concerning each cycle. The controller permits customizing of the cycles to the patient, has both manual and automatic modes of operation, and provides options to the patient in restarting interrupted cycles.

Claims

1. A peritoneal dialysis cycler of the gravity type for use with a patient, comprising:

(a) a stand having a base portion and an upstanding vertical portion;

(b) a single load cell attached to and supported by said stand;

(c) at least one fluid exchange bag supported by said load cell;

(d) at least one fluid drain bag supported by said load cell;

(e) a fill control valve;

(f) a drain control valve;

(g) a first electrical power supply and interface circuit electrically connected to said fill and drain control valves to convert low voltage signals into higher voltage or current signals to operate said fill and drain control valves;

(h) a second electrical power supply and interface circuit electrically connected to said load cell to convert low voltage signals generated by said load cell into data signals;

(i) computing means for controlling the operation of said fill and drain control valves via said first electrical power supply and interface circuit, and for receiving data signals from said second electrical power supply and interface circuit, said data signals being representative of the weight that is being measured by said load cell;

(j) a set of tubing for transferring liquids, said set of tubing comprising;

(1) a first length of tubing having a first end connected to said at least one fluid exchange bag and a second free end;

(2) a second length of tubing having a first end connected to said at least one fluid drain bag and a second free end;

(3) a third length of tubing having a first end operatively connected to said patient'"'"'s peritoneal space and a second free end;

(4) fitting means for interconnecting said free ends of said first, second and third lengths of tubing;

(k) said fill control valve being associated with said first length of tubing; and

(l) said drain control valve being associated with said second length of tubing.

2. The peritoneal dialysis cycler claimed in claim 1 wherein said stand has means for disassembly into compact parts for portability.

3. The peritoneal dialysis cycler claimed in claim 1 wherein said computing means comprises a laptop microcomputer having at least one input/output port.

4. The peritoneal dialysis cycler claimed in claim 1, wherein substantially zero force is required for said association of said fill control valve with said first length of tubing, and said drain control valve with said second length of tubing.

5. The peritoneal dialysis cycler claimed in claim 1, wherein each of said fill and drain control valves comprises a solenoid valve means for controlling the flow of fluid within a collapsible tube, a body, a plunger contained within a bore of said body, said plunger being axially shiftable between an extended, closed position and a retracted, open position, spring means for biasing said plunger to one of said open and closed positions, electrically-operated coil means for axially shifting said plunger to the other of said open and closed positions, said plunger terminating at one end in a tube-contacting nose portion, a shallow grove in an end surface of the body, said groove extending transversely thereof, said groove intersecting said bore;

a member pivotable between a first position wherein it overlies said groove in parallel spaced relationship to said body end surface and a second position remote from said groove, handle means on said member for manually shifting said member between said first and second positions, said second position enabling easy placement of said collapsible tube in said groove, and said first position retaining said collapsible tube within said groove, a portion of said member being chamfered such that said member can be shifted to said first position over said groove and said collapsible tube requiring substantially zero force, and said plunger and nose portion, when in said extended, closed position, collapsing said collapsible tube against said member to preclude fluid flow through said tube.

6. In a solenoid valve means for controlling the flow of fluid within a collapsible tube, a body, a plunger contained within a bore of said body, said plunger being axially shiftable between an extended, closed position and a retracted, open position, spring means for biasing said plunger to one of said open and closed positions, electrically-operated coil means for axially shifting said plunger to the other of said open and closed positions, said plunger terminating at one end in a tube-contacting nose portion, the improvement comprising:

(a) a shallow grove in an end surface of the body, said groove extending transversely thereof, said groove intersecting said bore, which is proximal to said nose portion;

(b) a member pivotable between a first position wherein it overlies said groove in parallel spaced relationship to said body end surface and a second position remote from said groove, handle means on said member for manually shifting said member between said first and second positions, said second position enabling easy placement of said collapsible tube in said groove and said first position retaining said collapsible tube within said groove, a portion of said member being chamfered such that said member can be shifted to said first position over said groove and said collapsible tube requiring substantially zero force, and said plunger and nose portion, when in said extended, closed position, collapsing said collapsible tube against said member to preclude fluid flow through said tube.

7. A solenoid valve as recited in claim 6, wherein said plunger and nose portion are in said extended, closed position when the valve is de-energized.

8. A solenoid valve as recited in claim 6, wherein said plunger and nose portion are in said retracted open position when the valve is de-energized.

9. A method of performing peritoneal dialysis upon a patient, said method comprising the following steps:

(a) providing a peritoneal dialysis cycler of the gravity-type which includes a single load cell supporting at least one fluid exchange bag and at least one fluid drain bag, a fill control valve and a drain control valve, computing means for controlling the operation of said fill and drain control valves via electrical interfacing circuitry, a set of tubing for transferring liquids from said at least one fluid exchange bag into the patient via said fill control valve, and a set of tubing for transferring liquids into said at least one fluid drain bag from the patient via said drain control valve;

(b) providing the patient with start-up instructions for a dialysis procedure of one or more cycles, via a video monitor under the control of said computing means, said start-up instructions including options for operating the cycler in manual or automatic mode, options for predetermining amounts of infusate and drain fluids, and options for controlling the timing parameters of each cycle by entering information into said computing means before the commencement of the overall dialysis procedure;

(c) commencing the dialysis procedure which comprises for each cycle thereof the additional steps of;

(1) measuring the gross weight supported by said load cell at the start of each cycle, including said at least one fluid exchange bag and said at least one fluid drain bag, to establish a first reference gross weight for that cycle;

(2) filling the patient'"'"'s peritoneal space with infusate fluid by opening said fill control valve while keeping said drain control valve in a closed position;

(3) periodically measuring the gross weight supported by said load cell during said filling step and comparing said gross weights to said first reference gross weight and thereby periodically determining the differential weight of infusate fluid which has passed into the patient;

(4) stopping said filling step by closing said fill control valve via said computing means when said differential weight at least equals a predetermined value entered in said computing means;

(5) retaining the infusate fluid within the patient'"'"'s peritoneal space for a predetermined dwell time interval by maintaining both fill and drain control valves closed;

(6) at the end of said predetermined dwell time, measuring the gross weight supported by said load cell to establish a second reference gross weight for that cycle;

(7) draining the patient'"'"'s peritoneal space by opening said drain control valve while keeping the fill control valve in a closed position;

(8) periodically measuring the gross weight supported by said load cell during said draining step and comparing said gross weights to said second reference gross weight and thereby periodically determining the differential weight of fluid which has drained from the patient;

(9) stopping said draining step by closing said drain control valve via said computing means when said differential weight of said drain fluid at least equals a predetermined value entered in said computing means;

(10) performing any additional cycles of said dialysis procedure according to steps 1 through 9; and

(d) providing the patient with the results of the completed dialysis procedure via said video monitor under the control of said computing means, including in said results information as to how much infusate fluid was placed into the patient'"'"'s peritoneal space and how much fluid was drained from the patient'"'"'s peritoneal space during each of said cycles.

10. A method as recited in claim 9, including the step of causing an alarm condition when a flow restriction occurs in either said set of tubing for transferring liquids from said at least one fluid exchange bag into the patient, or said set of tubing for transferring liquids into said at least one fluid drain bag from the patient.

11. A method as recited in claim 10, including the step of causing said computing means to display restart information on said video monitor for the patient'"'"'s further use of the peritoneal dialysis cycler upon the occurrence of said alarm condition.

12. A method as recited in claim 9, including the step of storing the results of the completed dialysis cycle onto a magnetic disk storage device under the control of said computing means.

13. A method as recited in claim 9, including the step of supplying a first voltage amplitude to each of said fill and drain control valves, for energizing said fill and drain control valves as required, to enable said fill and drain control valves to quickly and affirmatively change state from their de-energized positions to their energized positions, and, after a predetermined time interval, supplying a second voltage amplitude to each of said fill and drain control valves, as required, sufficient for maintaining said fill and drain control valves in their steady-state energized positions, said second voltage amplitude being less than said first voltage amplitude.