Portable persistaltic pump for peritoneal dialysis

• US 6,129,699 A
• Filed: 10/31/1997
• Issued: 10/10/2000
• Est. Priority Date: 10/31/1997
• Status: Expired due to Term

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Sorenson Development, Incorporated
• Inventors: Sorenson, James L., Winterton, Reed F., Herbst, Royce, Haight, Levoy G.
• Primary Examiner(s): Polutta, Mark O.
• Assistant Examiner(s): BIANCO, PATRICIA
• Application Number:
  US08/961,757
• Time in Patent Office: 1,075 Days
• Field of Search: 604/4-5, 604/19, 604/27-34, 604/153, 604/155, 417/477.2-477.6, 417/477.9, 417/477.12-477.13, 417/44.2
• 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 1/156 Constructional details of the cassette, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/1565 Details of valves
• CPC Class Codes: A61M 1/159 specially adapted for peritoneal dialysis
• 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 1/282 Operational modes
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 39/281 Automatic tube cut-off devices, e.g. squeezing tube on detection of air
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: F04B 2203/0209 Rotational speed
• CPC Class Codes: F04B 43/1276 Means for pushing the rollers against the tubular flexible member
• CPC Class Codes: F04B 49/065 and making use of computers

Abstract

A pump assembly for ambulatory peritoneal dialysis transfer procedures includes a portable power supply geared to drive a high-volume peristaltic pump. A cassette of the pump comprises an encasement; tubing including an inner portion positioned within the encasement, a patient-side portion for connection to an indwelling peritoneal dialysis catheter and an opposing portion connectable to a system for containment and communication of a peritoneal dialysis solution which may be one single-compartment bag assembly; a safety valve for selectively occluding and permitting the communication of the solution through the inner portion; and a filter preferably interposed along the patient-side portion which filters air and particles from peritoneal dialysate that is flowing toward a patient and which allows peritoneal dialysate to flow substantially freely and unfiltered away from the patient.

Claims

1. An apparatus for portable peritoneal dialysis procedures, comprising:

a transfer set in association with a high-volume peristaltic pump assembly, said pump assembly comprising;

a portable power supply;

a motor, powered by said power supply, and including;

a drive shaft capable of clockwise and counterclockwise rotation;

a displacement impeller assembly, mounted to turn within an impeller chamber in response to rotation of said drive shaft, and including;

a plurality of roller elements carried through a circular travel path within said impeller chamber,

said travel path being situated partially within a zone which presents a receptacle opening into said impeller chamber;

said transfer set comprising;

a cassette configured to install within said receptacle opening to occupy said zone, constituting an encasement for a segment of medical tubing, including a reaction surface constructed and arranged closely to approach said travel path when said cassette is installed within said receptacle; and

a length of medical tubing, including an intermediate segment positioned within said cassette adjacent said reaction surface, said length of medical tubing including;

a patient end releasably connectable to an indwelling peritoneal dialysis tube; and

an opposite end releasably connectable to an assembly for containment of dialysate solution.

2. The apparatus of claim 1, wherein said transfer set further comprises:

a safety valve for selectively permitting flow of a dialysate solution through said length of medical tubing.

3. The apparatus of claim 2, wherein said safety valve is carried by said cassette, and is structured and arranged so that it is normally biased closed and is urged open upon installation of said cassette in said receptacle.

4. The apparatus of claim 1, said pump assembly further comprising:

a check valve assembly in fluid flow communication with said length of medical tubing, said check valve assembly being structured and arranged to filter air and particles from fresh dialysate solution as it flows toward a patient and to allow free, unfiltered flow of spent dialysate solution away from a patient.

5. The apparatus of claim 1, said pump assembly further comprising:

electronic control means for said motor, said control means including circuitry for selectively governing actuation and operation of said motor to effect intermittent pump reversal in a selected pattern.

6. In combination, a high-volume, inexpensive, portable, closed system peristaltic pump and transfer set assembly for portable peritoneal dialysis procedures, comprising:

a motor assembly, including;

a battery power supply;

a drive shaft with a velocity of between 1,500 and 20,000 rotations per minute;

gear means for communicating drive shaft revolutions in a ratio of at least fifteen to one;

capability to drive volumetric flow rates in excess of 100 ml/minute for at least 20 minutes;

a spindle including;

a turn shaft in torque communication with the drive shaft, said turn shaft being located along a central axis of the spindle, the spindle being rotatable in two directions on a plane transverse the axis;

support structure affixed to and extending radially outward from the turn shaft to a periphery;

a plurality of wheels, each wheel being rotatable around a respective wheel axis, said wheel axis being transverse the plane;

said wheels being spaced evenly from each other and connected to the support structure at said periphery;

with

said transfer set comprising;

an encasement defining a continuous wall and a covering for said spindle, and

a tube including an intermediate portion positionable along the wall and formed of a biocompatible material, said intermediate portion being collapsible when compressed between said wall and one of said wheels and having a resilient memory against collapse;

a patient end releasably connectable to an indwelling peritoneal dialysis tube; and

an opposite end releasably connectable to an assembly for containment and transfer of the dialysate solution.

7. The assembly of claim 6 further comprising:

a check valve structured and arranged to filter air and particles from the dialysate solution as it flows toward a patient and to allow free, unfiltered flow of dialysate solution away from a patient.

8. The assembly of claim 6, further comprising:

circuitry means for selectively governing actuation and operation of said motor;

said circuitry comprising;

means for intermittent pump reversal in a selected pattern.

9. The assembly of claim 6, wherein said transfer set further comprises:

a safety valve for selectively occluding and permitting flow of a dialysate solution through said tube.

10. A system for portable peritoneal dialysis transfer procedures, comprising:

a portable peristaltic pump including;

battery-powered motor means for rotating a drive chain across a gear assembly to a reduced ratio of rotation;

spindle means rotatable at the reduced ratio of rotation in response to rotation of the drive chain for movement of a plurality of evenly spaced wheels against a resilient, compressible dialysate tube, said tube being seated against a rigid wall, said wall being defined by an encasement, said encasement providing a covering for a portion of said spindle means and for a portion of said tubing, and comprising;

a safety valve structured and arranged to selectively occlude or permit flow of the solution through the tube.

11. The system of claim 10, wherein:

a check valve is interposed along the tube, in fluid communication with the tube, and structured and arranged in combination with a filter to filter air and particles from a dialysate solution as said solution flows toward a patient and to allow free, unfiltered flow of the dialysate solution away from a patient.

12. The system of claim 10, wherein the dialysate tube comprises a patient end releasably connectable to an indwelling peritoneal dialysis tube and an opposite end in fluid communication with one single-compartment peritoneal dialysate container for containment of a dialysate solution prior to flow of the solution toward and after flow from a patient.

13. A transfer set for the exchange of dialysate solution;

comprising;

a length of medical tubing constituting a bidirectional flow path for dialysate solution between an indwelling patient catheter tube and a dialysate containment system;

a coupling carried at one end of said length of medical tubing for connection to said catheter tube;

structure in fluid flow communication with said length of medical tubing, said structure constituting means for directing fresh dialysate solution traveling through said tubing towards said coupling through a first travel path and directing spent dialysate solution traveling through said tubing from said coupling through a second travel path;

a biofilter in circuit with said first travel path; and

a check valve assembly in fluid flow communication with said length of medical tubing, said check valve assembly including said biofilter and being structured and arranged to filter air and particles from fresh dialysate solution as said fresh dialysate flows toward a patient and to allow free, unfiltered flow of spent dialysate solution away from a patient.

14. A transfer set according to claim 13, including:

a positive displacement pump in which said length of medical tubing functions as a resilient pump chamber;

said pump chamber being positioned within a housing comprising a support surface for said resilient chamber such that dialysate is urged through said resilient chamber by a traveling roller assembly associated with said housing;

said roller assembly being structured and arranged to press a roller surface against a section of said resilient chamber towards said support surface, whereby to reduce the transverse cross section of said tubing between said roller surface and said support surface, while said roller surface travels away from an inlet to said resilient chamber and towards an outlet from said resilient chamber;

said resilient pump chamber and said support surface being provided in a cassette;

said roller assembly being provided in association with a drive mechanism organized such that said roller surface travels repetitively within an open sided housing from an inlet towards an outlet;

said open sided housing being structured to receive said cassette in an installed condition;

said housing and cassette being mutually adapted so that when said cassette is in said installed condition, said resilient chamber is functionally positioned with respect to said roller assembly; and

a normally biased closed valve being provided in association with said cassette, said valve being structured and arranged to open when said cassette is in its installed condition.

15. A transfer set according to claim 13, including a safety valve for selectively permitting flow of a dialysate solution through said length of medical tubing.

16. In combination, a high-volume, inexpensive, portable, closed system peristaltic pump and transfer set assembly for portable peritoneal dialysis procedures, comprising:

a motor including;

a battery power supply;

a drive shaft with a velocity of between 1,500 and 20,000 rotations per minute;

gear means for communicating drive shaft revolutions in a ratio of at least fifteen to one;

capability to drive volumetric flow rates in excess of 100 ml/minute for at least 20 minutes;

a spindle including;

a turn shaft in torque communication with the drive shaft, said turn shaft being located along a central axis of the spindle,

the spindle being rotatable in two directions on a plane transverse the axis;

support structure or spokes affixed to and extending radially outward from the turn shaft to a periphery;

a plurality of wheels, each wheel being rotatable around a respective wheel axis, said wheel axis being transverse the plane;

said wheels being spaced evenly from each other and connected to the support structure at said periphery;

a transfer set comprising;

an encasement defining a continuous wall and a covering for said spindle, and

a tube including;

an intermediate portion positionable along the wall and formed of a biocompatible material said intermediate portion being collapsible when compressed between the wall and one of the wheels and having a resilient memory against collapse;

a patient end releasably connectable to an indwelling peritoneal dialysis tube; and

an opposite end releasably connectable to an assembly for containment and transfer of the dialysate solution; and

circuitry means for selectively governing actuation, direction and operation of said motor;

said circuitry means comprising sensor means for detecting pressure changes based upon changes of rotational rate per time interval of the drive shaft or turn shaft.

17. The assembly of claim 16, further comprising second valve means for ensuring that used dialysate substantially entirely circumvents the filter media.

18. A system for a portable peritoneal dialysis transfer procedure, comprising:

a portable peristaltic pump including;

a battery-operated motor, comprising;

a drive shaft,

gear means for communicating drive shaft revolutions in a reduced ratio, and capability to drive flow rates suitable for peritoneal dialysate transfer;

a spindle rotatable on a spindle plane in ratio-reduced response to operation of said motor, wherein a plurality of wheels is rotatable on a plane non-perpendicular to the spindle plane, said wheels being spaced evenly from each other and affixed to a support structure said support structure appending from the spindle;

an encasement defining a wall;

a transfer tube releasably connected to and in fluid communication with an indwelling peritoneal dialysis tube at a patient end of said transfer tube, an intermediate portion of the transfer tube resiliently collapsible when compressed between the wall and any of said wheels;

circuitry means for selectively governing actuation and operation of said motor;

a check valve interposed along the tube, in fluid communication with the tube, and structured and arranged to filter air and particles from a dialysate solution as it flows toward a patient and to allow substantially free, unfiltered flow of the dialysate solution away from a patient; and

one single-compartment peritoneal dialysate container in fluid communication with said transfer tube at an opposite end of said transfer tube relative to said patient end for containment of the dialysate prior to flow toward and after flow from the patient.

19. Apparatus for the micro-evacuation of fluids from a body, comprising:

a conduit, having a first end adapted to receive fluid from a body and a second end adapted to discharge said fluid into a disposal site;

a pump mechanism with a chamber communicating with said conduit between said first and second ends, said pump mechanism being constructed and arranged alternately to draw fluid into said chamber from said conduit during an intake phase and to discharge fluid from said chamber into said conduit during an exhaust phase;

a first valve operable selectively to open or close flow between said chamber and the portion of said conduit between said chamber and said first end;

a second valve operable selectively to open or close flow between said chamber and the portion of said conduit between said chamber and said second end; and

control means for coordinating the operation of said first and second valves with said intake and exhaust phases, whereby to alternate the direction of flow within said conduit such that there is a net flow from said first end to said second end.