Medical treatment system and methods using a plurality of fluid lines

• US 9,078,971 B2
• Filed: 11/02/2012
• Issued: 07/14/2015
• 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.
• Primary Examiner(s): Bosques, Edelmira
• Application Number:
  US13/667,696
• Publication Number:
  US 20130184638A1
• Time in Patent Office: 984 Days
• Field of Search: 604/291, 604/6.13, 604/113
• US Class Current: 1/1
• 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;

wherein the cycler includes;

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

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;

wherein the control surface is 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 space 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

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

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 includes 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. The system of claim 6, wherein the plurality of ports are also arranged to introduce fluid into the space between the first and second flexible membranes.

8. The system of claim 1, wherein the at least one port includes a hole in the second flexible membrane through which a raised second port of the pressure delivery block passes.

9. The system of claim 1, wherein the second flexible membrane includes:

one or more control regions each 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 of the second flexible membrane; and

a perimeter region arranged to fit the second flexible membrane securely over a pressure delivery block of the cycler, 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 one or more 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.

10. 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;

wherein the cycler includes;

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; and

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;

wherein the second flexible membrane is mounted on the second side of the pressure delivery block and has 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 chamber of the pumping cassette; and

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