MEDICAL TREATMENT SYSTEM AND METHODS USING A PLURALITY OF FLUID LINES

• US 20180361048A1
• Filed: 05/29/2018
• Published: 12/20/2018
• Est. Priority Date: 11/04/2011
• Status: Active Grant

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Scarpaci, Jacob W., Bryant, JR., Robert J., 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 10,881,778 B2
• Time in Patent Office: Days
• CPC Class Codes: A61M 1/1522 the interface being evacuated interfaces to enhance contact
• CPC Class Codes: A61M 1/153 the cassette being adapted for heating or cooling the treating fluid, e.g. the dialysate or the treating gas
• 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 1/1664 with temperature control
• 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 2205/122 using evacuated interfaces to enhance contact
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3327 Measuring
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/36 related to heating or cooling
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8212 with means or measures taken for minimising energy consumption
• CPC Class Codes: A61M 2210/1017 : Peritoneal cavity
• CPC Class Codes: A61M 60/113 : in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: F04B 43/02 : having plate-like flexible members, e.g. diaphragms F04B43/14 takes precedence
• CPC Class Codes: F16L 53/00 : Heating of pipes or pipe systems; Cooling of pipes or pipe systems
• CPC Class Codes: F17D 1/00 : Pipe-line systems conveying articles or materials through a pipe- line by means of a fluid carrier B65G51/00, B65G53/00; liquids B67D; special devices for transferring liquids from bulk storage containers into vehicles or boats or vice versa, e.g. loading or unloading vehicles or portable containers B67D7/00; conveying material which has been excavated by a dredger or soil shifter through a pipe-line E02F7/10; sewer pipe-line systems E03F3/00; thermal insulation of pipe-lines F16L59/00; central heating systems F24D
• CPC Class Codes: H05B 1/025 : For medical applications
• CPC Class Codes: Y02E 60/10 : Energy storage using batteries
• CPC Class Codes: Y10T 137/6416 : With heating or cooling of the system
• CPC Class Codes: Y10T 137/85978 : With pump

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

1-13. -13. (canceled)

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.

28-47. -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.