Pump cassette and methods for use in medical treatment system using a plurality of fluid lines

• US 9,358,332 B2
• Filed: 01/23/2009
• Issued: 06/07/2016
• Est. Priority Date: 01/23/2008
• Status: Active Grant

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: McGill, David W., Dale, James D., Helmore, Simon C., Lanigan, Richard J., Demers, Jason A., Kamen, Dean
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): PATEL, SHEFALI DILIP
• Application Number:
  US12/864,378
• Publication Number:
  US 20110092894A1
• Time in Patent Office: 2,692 Days
• Field of Search: 604/27, 604/29
• US Class Current: 1/1
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00 ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/1522 the interface being evacuated interfaces to enhance contact
• 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 1/153 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 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1623 Disposition or location of membranes relative to fluids
• CPC Class Codes: A61M 1/1629 with integral heat exchanger
• CPC Class Codes: A61M 1/1631 having non-tubular membranes, e.g. sheets
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• CPC Class Codes: A61M 1/1694 with recirculating dialysing liquid
• 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 1/288 Priming priming in extracorporeal blood circuits A61M1/3643
• CPC Class Codes: A61M 2039/1066 having protection means, e.g. sliding sleeve to protect connector itself, shrouds to protect a needle present in the connector, protective housing, isolating sheath
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/121 : interface between cassette and base
• CPC Class Codes: A61M 2205/122 : using evacuated interfaces to enhance contact
• CPC Class Codes: A61M 2205/123 : with incorporated reservoirs
• CPC Class Codes: A61M 2205/127 : with provisions for heating or cooling
• CPC Class Codes: A61M 2205/128 : with incorporated valves
• 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 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3379 : Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/36 : related to heating or cooling
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/6036 : characterised by physical shape, e.g. array of activating switches
• CPC Class Codes: A61M 2209/08 : Supports for equipment
• CPC Class Codes: A61M 39/1011 : Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• CPC Class Codes: A61M 39/105 : Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes multi-channel connectors in general F16L37/56
• CPC Class Codes: A61M 39/20 : Closure caps or plugs for connectors or open ends of tubes
• CPC Class Codes: A61M 39/28 : Clamping means for squeezing flexible tubes, e.g. roller clamps tube strippers A61M1/83
• CPC Class Codes: A61M 39/281 : Automatic tube cut-off devices, e.g. squeezing tube on detection of air
• CPC Class Codes: A61M 5/16809 : by repeated filling and emptying of an intermediate volume pressure infusion using positive displacement pumps A61M5/142
• CPC Class Codes: A61M 5/16813 : by controlling the degree of opening of the flow line
• CPC Class Codes: A61M 5/16827 : controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: F04B 43/0054 : particularities of the flexible members
• CPC Class Codes: F04B 43/02 : having plate-like flexible members, e.g. diaphragms F04B43/14 takes precedence
• CPC Class Codes: F04B 43/073 : the actuating fluid being controlled by at least one valve
• CPC Class Codes: F04B 43/08 : having tubular flexible members F04B43/12 takes precedence
• CPC Class Codes: F04B 43/086 : with two or more tubular flexible members in parallel F04B43/1136 takes precedence
• CPC Class Codes: F04B 53/22 : Arrangements for enabling ready assembly or disassembly
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

A fluid handling cassette, such as that useable with an automated peritoneal dialysis (APD) cycler device or other infusion apparatus, may include a generally planar body having at least one pump chamber formed as a depression in a first side of the body and a plurality of flowpaths for a fluid that includes a channel. A patient line port may be arranged for connection to a patient line and be in fluid communication with the at least one pump chamber via at least a first one of said flowpaths, and an optional membrane may be attached to the first side of the body over the at least one pump chamber. In one embodiment, the membrane may have a pump chamber portion with an unstressed shape that generally conforms to the depression of the at least one pump chamber in the body and is arranged to be movable for movement of the fluid in a useable space of the at least one pump chamber. One or more spacers may be provided in the at least one pump chamber to prevent the membrane from contacting an inner wall of the at least one pump chamber. The patient line, a drain line, and/or a heater bag line may be positioned to be separately occludable in relation to one or more solution lines that are connectable to the cassette.

Claims

1. A fluid handling cassette for use with a fluid handling system of a medical infusion device, the cassette comprising:

a generally planar body having at least one pump chamber formed as a depression in a first side of the body and a plurality of flowpaths for a fluid that includes a channel, the at least one pump chamber including a plurality of spacer elements having ends that extend from a flat bottom inner wall of the depression, at least some of the spacer elements varying in height;

a patient line port arranged for connection to a patient line, the patient line port being in fluid communication with the at least one pump chamber via at least a first one of said flowpaths;

a drain line port arranged for connection to a drain line, the drain line port being in fluid communication with the at least one pump chamber via at least a second one of said flowpaths; and

a flexible membrane attached to the first side of the body over the at least one pump chamber, a first portion of the flexible membrane over the at least one pump chamber being arranged to be movable for movement of the fluid in the at least one pump chamber, and second portions of the flexible membrane positioned over respective valves and movable to open and close the respective valves;

wherein said first portion of the flexible membrane has a shape arranged to conform to a usable area of a corresponding pump chamber while at rest and without being stressed, the usable area of the corresponding pump chamber being defined in part by the plurality of spacer elements.

2. The cassette of claim 1, wherein the spacer elements are arranged to minimize deformation of the flexible membrane at edges of the spacer elements when the flexible membrane is forced against the spacer elements.

3. The cassette of claim 1, wherein the spacer elements are arranged in a concentric elliptical pattern.

4. The cassette of claim 3, wherein the concentric elliptical pattern of the spacer elements includes breaks in the pattern.

5. The cassette of claim 4, wherein the breaks in the pattern are symmetrical.

6. The cassette of claim 1, wherein the spacer elements vary in height such that the ends of the spacer elements increase in height from the bottom inner wall with distance away from a center of the at least one pump chamber.

7. The cassette of claim 6, wherein the ends of the spacer elements form a semi-elliptical domed shaped region.

8. The cassette of claim 1, wherein the body includes a vacuum vent clearance depression formed adjacent to, extending from, and fluidly connected to the at least one pump chamber, the vacuum vent clearance depression arranged to allow a vacuum vent port of a pump control region of a control surface to remove fluids from between the flexible membrane and the control surface without obstruction.

9. The cassette of claim 8, wherein the vacuum vent clearance depression extends outwards from the at least one pump chamber.

10. The cassette of claim 1, further comprising a plurality of solution line spikes being in fluid communication with the at least one pump chamber via at least the first one of said flowpaths.

11. A fluid handling cassette for use in a fluid handling system useable in a medical infusion application, the cassette comprising:

a generally planar body having at least one pump chamber formed as a depression in a first side of the body and a plurality of flowpaths for a fluid that includes a channel, the at least one pump chamber including a plurality of spacer elements having ends that extend from a flat bottom inner wall of the depression, at least some of said spacer elements varying in height, and said at least one pump chamber including a fluid outlet;

a patient line port arranged for connection to a patient line, the patient line port being in fluid communication with the at least one pump chamber via at least a first one of said flowpaths;

a drain line port arranged for connection to a drain line, the drain line port being in fluid communication with the at least one pump chamber via at least a second one of said flowpaths; and

a flexible membrane attached to the first side of the body over the at least one pump chamber, a first portion of the flexible membrane over the at least one pump chamber being arranged to be movable for movement of the fluid in the at least one pump chamber, and second portions of the flexible membrane positioned over respective valves and movable to open and close the respective valves;

wherein said first portion of the flexible membrane has a shape arranged to conform to a usable area of a corresponding pump chamber while at rest and without being stressed, the usable area of the corresponding pump chamber being defined in part by the plurality of spacer elements, and said plurality of spacer elements are configured to inhibit the flexible membrane from covering the fluid outlet.

12. The cassette of claim 11, further comprising a plurality of solution line spikes being in fluid communication with the at least one pump chamber via at least the first one of said flowpaths.

13. A fluid handling cassette for use with a fluid handling system of a medical infusion device, the cassette comprising:

a generally planar body having at least one pump chamber formed as a depression in a first side of the body and a plurality of flowpaths for a fluid that includes a channel, the at least one pump chamber including one or more spacer elements having ends that extend from an inner wall of the depression, at least some of said spacer elements varying in height;

a patient line port arranged for connection to a patient line, the patient line port being in fluid communication with the at least one pump chamber via at least a first one of said flowpaths;

a drain line port arranged for connection to a drain line, the drain line port being in fluid communication with the at least one pump chamber via at least a second one of said flowpaths; and

a flexible membrane attached to the first side of the body over the at least one pump chamber, the flexible membrane being sealed against a periphery of the body to prevent the fluid from leaking from the cassette, a first portion of the flexible membrane over the at least one pump chamber being arranged to be movable for movement of the fluid in the at least one pump chamber, and second portions of the flexible membrane positioned over respective valves and movable to open and close the respective valves, said first portion of the flexible membrane having a shape arranged to conform to a usable area of a corresponding pump chamber while at rest and without being stressed, the usable area of the corresponding pump chamber being defined in part by the one or more spacer elements;

wherein the body includes a vacuum vent clearance depression formed adjacent to, extending from, and in fluid communication with the at least one pump chamber, said vacuum vent clearance depression configured to allow a vacuum vent port of the medical infusion device to remove air or a fluid between the flexible membrane and a control surface of the medical infusion device when the fluid handling cassette is installed in the medical infusion device.

14. The cassette of claim 13, wherein the vacuum vent clearance depression extends outside of a perimeter of the at least one pump chamber.