MEDICAL TREATMENT SYSTEM AND METHODS USING A PLURALITY OF FLUID LINES

• US 20130184638A1
• Filed: 11/02/2012
• Published: 07/18/2013
• Est. Priority Date: 01/23/2008
• Status: Active Grant

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Scarpaci, Jacob W., Bryant, Robert J. Jr., Spencer, Geoffrey P., Hibbard, David J., Dale, James D., Kerwin, John M., Coll, Andrew S., Beavers, David A., McGill, David W., Helmore, Simon C.
• Granted Patent: US 9,078,971 B2
• Time in Patent Office: Days
• US Class Current: 604/28
• CPC Class Codes: A61M 1/1522 the interface being evacuated interfaces to enhance contact
• 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 1/1565 Details of valves
• CPC Class Codes: A61M 1/159 specially adapted for peritoneal dialysis
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• 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 1/288 Priming priming in extracorporeal blood circuits A61M1/3643
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: G01V 8/20 using multiple transmitters or receivers

Abstract

A medical treatment system, such as peritoneal dialysis system, may include control and other features to enhance patient comfort and ease of use. For example, a peritoneal dialysis system may include a control system that can adjust the volume of fluid infused into the peritoneal cavity to prevent the intraperitoneal fluid volume from exceeding a pre-determined amount. The control system can adjust by adding one or more therapy cycles, allowing for fill volumes during each cycle to be reduced. The control system may continue to allow the fluid to drain from the peritoneal cavity as completely as possible before starting the next therapy cycle. The control system may also adjust the dwell time of fluid within the peritoneal cavity during therapy cycles in order to complete a therapy within a scheduled time period. The cycler may also be configured to have a heater control system that monitors both the temperature of a heating tray and the temperature of a bag of dialysis fluid in order to bring the temperature of the dialysis fluid rapidly to a specified temperature, with minimal temperature overshoot.

Claims

1. A dialysis system comprising:

a pumping cassette having a generally planar body and a first flexible membrane on a side of the cassette overlying a pumping chamber on the cassette; and

a cycler having a control surface including a second flexible membrane arranged to contact and mate with the first flexible membrane of the pumping cassette, the cycler being arranged to move one or more portions of the second flexible membrane to move at least a portion of the first flexible membrane overlying a pumping chamber on the cassette to cause fluid flow in the pumping chamber, the cycler further including at least one port at the control surface arranged to remove fluid in a space between the first and second flexible membranes to draw the first and second flexible membranes toward each other and to introduce fluid into the space to move the first and second flexible membranes away from each other.

2. The system of claim 1, wherein the at least one port includes a vacuum port arranged to selectively remove fluid in the space between the first and second flexible membranes, or introduce fluid into the space between the first and second flexible membranes.

3. The system of claim 2, wherein the fluid removed between the between the first and second flexible membranes includes air or liquid, and the fluid introduced between the first and second flexible membranes includes air.

4. The system of claim 1, wherein the control surface is a sheet of resilient polymer material.

5. The system of claim 1, wherein the control surface include a plurality of movable portions, at least one movable portion being arranged to interact with the portion of the first flexible membrane overlying the pumping chamber, and at least one other movable portion being arranged to interact with another portion of the first flexible membrane to control flow in a channel of the pumping cassette.

6. The system of claim 1, wherein the control surface includes a plurality of ports to remove fluid in a space between the first and second flexible membranes.

7-12. -12. (canceled)

13. A system for mating a fluid pumping cassette with a base unit that provides positive and negative pressure to the pumping cassette comprising:

a pumping cassette having a generally planar body and a first flexible membrane on a side of the cassette overlying a pumping chamber on the cassette;

a base unit comprising a source of positive pressure, a source of negative pressure, a pressure distribution manifold, a pressure delivery block, and a control surface;

the pressure distribution manifold comprising valved channels between the positive and negative pressure sources and the pressure delivery block;

the pressure delivery block comprising a depression in valved fluid communication with the positive and negative pressure sources, the depression arranged to mate with a pumping chamber of the cassette;

the control surface comprising a second flexible membrane and positioned on the pressure delivery block so as to be interposed between the first flexible membrane of the cassette and the depression of the pressure delivery block;

wherein

the pressure distribution manifold is configured to provide a valved channel between the negative pressure source and the region between the opposing first and second flexible membranes to generate a vacuum seal between the first and second flexible membranes for operation of the pumping cassette, and

the pressure distribution manifold is configured to provide a valved channel between the positive pressure source and a region between the opposing first and second flexible membranes to facilitate disengagement of the pumping cassette from the base unit.

14. A method for performing peritoneal dialysis using a pre-determined total volume of dialysate and comprising a plurality of therapy cycles, each cycle comprising infusing dialysate into a peritoneal cavity, allowing dialysate to dwell in the peritoneal cavity for a period of time, and draining dialysate from the peritoneal cavity, the method comprising:

selecting a value for a maximum volume of dialysate that may reside in the peritoneal cavity;

selecting a value for a first infusion volume of dialysate to be infused into the peritoneal cavity;

estimating a volume of ultrafiltration fluid produced in the peritoneal cavity during a therapy cycle;

measuring the volume of dialysate infused in the peritoneal cavity during a cycle;

measuring the volume of dialysate drained from the peritoneal cavity during the cycle;

estimating a volume of residual dialysate remaining in the peritoneal cavity; and

initiating a new therapy cycle before the total of the infused volume plus the estimated ultrafiltered volume of fluid have been drained as long as an estimated residual volume of dialysate in the peritoneal cavity plus the amount of the infused volume plus the estimated ultrafiltered volume in the new therapy cycle does not exceed the maximum volume of dialysate that may reside in the peritoneal cavity.

15-17. -17. (canceled)

18. A peritoneal dialysis system for performing peritoneal dialysis using a pre-determined total volume of dialysate and arranged to employ a plurality of therapy cycles comprising a fill phase in which dialysate is delivered from the dialysis system via a patient line, a dwell phase, and a drain phase in which fluid is drained via a drain line, the system comprising:

at least one pump chamber controllable to move fluid;

a patient line in fluid communication with the at least one pump chamber to receive dialysate from the at least one pump chamber for delivery;

a drain line in fluid communication with the at least one pump chamber to deliver fluid to the at least one pump chamber;

a plurality of valves to selectively control flow in flow channels of the dialysis system; and

a control system arranged to control the dialysis system to perform the following;

control the at least one pump chamber and the plurality of valves to deliver a first infusion volume of dialysate to the patient line as part of a therapy cycle;

measure a volume of dialysate delivered to the patient line during the therapy cycle;

control the at least one pump chamber and the plurality of valves to receive fluid from the drain line as part of the therapy cycle;

measure a volume of fluid received from the drain line during the therapy cycle;

estimate a volume of ultrafiltration fluid produced during the therapy cycle;

estimate a volume of residual fluid for the therapy cycle based on the measured volume of fluid received, the estimated ultrafiltration fluid produced and the measured volume of dialysate delivered;

determine a value for a maximum volume of fluid at the end of a dwell phase; and

initiate a next therapy cycle if the estimated residual volume of fluid for the cycle plus a volume of dialysate to be delivered for the next therapy cycle plus an estimated volume of ultrafiltration fluid produced for the next therapy cycle does not exceed the maximum volume of fluid at the end of a dwell phase.

19. A system for controlling a temperature of a solution line connector having a pierceable seal through which a hollow spike may be connected, comprising:

a carriage on which the connector is placed;

a sensor mounted on the carriage to detect the temperature of the connector;

a heating or cooling element positioned near the connector to affect the temperature of the connector; and

a controller to receive temperature data from the sensor and to control the heating or cooling element.

20. (canceled)

21. A gasket for transferring positive or negative pressure from a peritoneal dialysis apparatus to a pumping cassette, the cassette having a generally planar body and a first flexible membrane covering one or more pump or valve chambers on the cassette, the gasket comprising:

one or more control regions, each comprising a second flexible membrane arranged to align with one or more pumping or valve chambers on the pumping cassette, the pumping or valve chambers each bounded by at least a portion of the first flexible membrane, each said portion of the first flexible membrane arranged to make direct contact with an opposing control region;

a perimeter region arranged to fit the gasket securely over a pressure delivery block of the peritoneal dialysis apparatus, the pressure delivery block configured to channel positive or negative pressure to the one or more control regions;

wherein

a surface of each of the control regions facing the first flexible membrane is roughened or textured to form a porous layer of the surface of the control region when placed in contact with the first flexible membrane.

22. A disposable component system for use with a fluid line connection system of a peritoneal dialysis system, the disposable component system comprising:

a fluid handling cassette comprising;

a generally planar body with at least one pump chamber formed as a depression in a first side of the body and a plurality of flowpaths for fluid;

a solution line spike located at a first end of the body, the solution line spike being in fluid communication with the at least one pump chamber via at least one flowpath; and

a spike cap configured to removably cover the solution line spike, wherein the cap includes at least a flange on an outer surface of the spike cap to aid in removal of the cap from the spike for connection of the spike to a solution line, and a barb on the outer surface of the spike cap configured to engage the spike cap with a hole of a solution line cap.

23-26. -26. (canceled)

27. A pressure distribution module for a fluid flow control apparatus configured to operate a membrane-based pumping cassette, the module comprising:

a manifold comprising an inlet port for positive pressure and an inlet port for negative pressure, and a plurality of channels and valves arranged to selectively connect a source of positive or negative pressure to a plurality of outlet channels;

a pressure delivery block configured to mate with a side of the manifold, wherein a plurality of outlet channels of the manifold fluidly connect with opposing ports on a first side of the pressure delivery block, the opposing ports on the first side of the pressure delivery block fluidly connected to corresponding outlet ports on an opposing second side of the pressure delivery block; and

a control gasket mounted on the second side of the pressure delivery block and having a plurality of control regions, each control region having a first side positioned opposite an outlet port of the pressure delivery block, and each control region having an opposing second side configured to contact and actuate a pumping or valve membrane of a pumping cassette;

wherein

each control region may be positively or negatively pressurized through a corresponding outlet port of the pressure delivery block.

28-37. -37. (canceled)

38. A heating system for a peritoneal dialysis apparatus comprising:

a pumping apparatus configured to pump dialysate into or out of a heater bag;

an electric heater configurable to operate at an AC line voltage in a range of about 100 to 120 volts or an AC line voltage in a range of about 200 to 240 volts;

a controller configured to control a temperature of the dialysate using the electrical heater; and

a universal power supply configured to convert line voltage to one or more DC voltages to power the pumping apparatus and controller, and to configure the electric heater to operate at a voltage in a range of about 100 to 120 volts or in a range of about 200 to 240 volts, based on a measured current flow through the electrical heater.

39. (canceled)

40. (canceled)

41. A method of configuring heating elements of an electrical heater for a peritoneal dialysis apparatus, the electrical heater comprising two heating elements, an end of each heating element connected to a common point, the method comprising:

configuring the heating elements initially in a series configuration;

connecting the electrical heater to line voltage;

measuring electrical current flow through the electrical heater;

determining from the measured current flow whether the line voltage is in a range of about 100-120 volts, or in a range of about 200-240 volts;

providing a user of the peritoneal dialysis apparatus with information about the determined line voltage; and

receiving a verification signal from the user before finally configuring the heating elements in either a series configuration or a parallel configuration.

42. A heating system for a peritoneal dialysis apparatus comprising:

a heater bag containing dialysate solution and positioned on a heater pan;

a pumping apparatus configured to pump dialysate into and out of the heater bag;

an electrical heating element to heat the heater pan;

one or more heater pan temperature sensors to detect a temperature of the heater pan;

a dialysate temperature sensor mounted in the heater pan, thermally isolated from the heater pan, and configured to contact an outer surface of the heater bag; and

a controller programmed to perform an inner control loop process that modulates electrical power provided to the heating element to achieve a target heater pan temperature as measured by the one or more heater pan temperature sensors, and programmed to perform an outer control loop process that determines the target heater pan temperature based on a difference between a pre-determined target dialysate temperature and the dialysate temperature as measured by the dialysate temperature sensor.

43. A liquid heating system comprising:

a heater bag containing a liquid and positioned on a heater pan;

a pumping apparatus configured to pump liquid into and out of the heater bag;

an electrical heating element to heat the heater pan;

one or more heating pan temperature sensors to detect a temperature of the heater pan;

a liquid temperature sensor mounted in the heater pan, thermally isolated from the heater pan, and configured to contact an outer surface of the heater bag; and

a controller programmed to perform an inner control loop process that modulates electrical power provided to the heater element to achieve a target heater pan temperature as measured by the one or more heater pan temperature sensors, and programmed to perform an outer control loop process that determines the target heater pan temperature based on a difference between a pre-determined target liquid temperature and an equilibrium temperature, wherein

the equilibrium temperature is a weighted average of the liquid temperature and the heater pan temperature, the liquid temperature being weighted by a thermal capacitance, mass, or volume of liquid present in the heater bag, and the heater pan temperature being weighted by a thermal capacitance, mass, or volume of the heater pan.

44. A liquid heating system comprising:

a heater bag containing a liquid and positioned on a heater pan;

a pumping apparatus configured to pump liquid into and out of the heater bag;

an electrical heating element to heat the heater pan;

one or more heating pan temperature sensors to detect the temperature of the heater pan;

a liquid temperature sensor mounted in the heater pan, thermally isolated from the heater pan, and configured to contact an outer surface of the heater bag; and

a controller programmed to perform an inner control loop process that modulates electrical power provided to the heater element to achieve a target heater pan temperature as measured by the one or more heater pan temperature sensors, and programmed to perform an outer control loop process that determines the target heater pan temperature based on a difference between a pre-determined target liquid temperature and an equilibrium temperature, wherein

the equilibrium temperature is a weighted average of the liquid temperature and the target heater pan temperature, the liquid temperature being weighted by a thermal capacitance, mass, or volume of liquid present in the heater bag, and the target heater pan temperature being weighted by the thermal capacitance, mass, or volume of the heater pan.

45-47. -47. (canceled)

48. A control system for a medical fluid delivery apparatus comprising:

a pumping apparatus configured to pump fluid to a patient from one or more source containers of fluid, or from a patient to a receptacle, the apparatus comprising one or more pumps, one or more valves, and fluid connections among the pumps, valves and the source containers or receptacle of fluid;

one or more pressure sensors to detect pumping pressures of the one or more pumps;

a first processor configured to control a sequence and timing of valve and pump operations to implement a pumping of fluid from one or more source containers to the patient or from the patient to the receptacle, and configured to monitor one or more volumes of fluid being pumped; and

a second processor configured to implement commands of the first processor and to provide data to the first processor, wherein the second processor is configured to;

collect and store data received from the pressure sensors at pre-determined fixed rate;

provide the stored data to the first processor on command from the first processor;

control the pumping pressure of the one or more pumps on a pre-determined fixed schedule; and

to

open or close the valves on command from the first processor.

49. A power management system for a medical device while operating on battery power comprising:

a medical device having a plurality of functions, each function associated with one of a pre-determined number of levels of power consumption;

an electronic circuit configured to measure an amount of charge remaining in a battery powering the medical device, and to associate the amount of charge with one of the pre-determined levels of power consumption; and

a controller configured to allow the medical device to perform one or more functions of the plurality of functions, as long as the one or more functions and the measured amount of charge are associated with the same level of power consumption.