Medical fluid cassette leak detection methods and devices

• US 10,539,481 B2
• Filed: 01/05/2017
• Issued: 01/21/2020
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Inventors: Plahey, Kulwinder S., Zhu, Jie, Ly, Tri, Ohline, Robert Matthew, Crawford, William Scott
• Primary Examiner(s): Fitzgerald, John
• Application Number:
  US15/399,043
• Publication Number:
  US 20170115178A1
• Time in Patent Office: 1,111 Days
• 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 1/154 with sensing means or components thereof
• 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 1/159 specially adapted for peritoneal dialysis
• CPC Class Codes: A61M 1/16 with membranes
• 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 2205/07 having air pumping means
• 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 2205/123 with incorporated reservoirs
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: G01M 3/3218 for flexible or elastic containers
• CPC Class Codes: G01M 3/3272 for verifying the internal pressure of closed containers
• CPC Class Codes: G01M 3/36 : by detecting change in dimensions of the structure being tested

Abstract

A method is provided for detecting leaks in a disposable medical fluid cassette that includes a base and a flexible membrane attached to the base in such a way that the base and the flexible membrane cooperate to at least partially form a fluid passageway. The method includes applying a first force to the flexible membrane, measuring a first physical property of a system that includes the medical fluid cassette a medical fluid pumping machine, removing the first force from the flexible membrane, applying a second force to the flexible membrane, measuring a second physical property of the system, and determining whether the medical fluid cassette leaks based on a comparison of the first physical property and the second physical property.

Claims

1. A medical fluid pumping machine configured to receive a disposable medical fluid cassette, the medical fluid cassette comprising a base and a flexible membrane attached to the base in such a way that the base and the flexible membrane cooperate to at least partially form a fluid passageway, the medical fluid pumping machine comprising:

a compartment that receives the medical fluid cassette,

a pressure applicator configured to apply a force to the medical fluid cassette when the medical fluid cassette is disposed within the compartment;

a processer that is configured to

control the pressure applicator in such a way that a first force is applied to the flexible membrane when the medical fluid cassette is disposed within the compartment;

measure a first physical property of a system that includes the medical fluid pumping machine with the medical fluid cassette disposed within the compartment while the first force is applied to the flexible membrane;

control the pressure applicator in such a way that the first force is removed from the flexible membrane when the medical fluid cassette is disposed within the compartment;

control the pressure applicator in such a way that a second force is applied to the flexible membrane when the medical fluid cassette is disposed within the compartment;

measure a second physical property of the system that includes the medical fluid pumping machine with the medical fluid cassette disposed within the compartment while the second force is applied to the flexible membrane; and

determine whether the medical fluid cassette leaks based on a comparison of the first physical property and the second physical property.

2. The medical fluid pumping machine of claim 1, comprising

a door that is configured to selectively close the compartment and retain the medical fluid cassette within the compartment, and

an inflatable bladder disposed on an inside surface of the door and configured such that

when inflated while the medical fluid cassette is within the compartment, the inflatable bladder is configured to compress the medical fluid cassette, and

when deflated while the medical fluid cassette is within the compartment, the inflatable bladder is configured to contract against the inside surface of the door and generate a space between the inflatable bladder and the medical fluid cassette, wherein

the processer is configured to deflate the door bladder between controlling the pressure applicator in such a way that the first force is removed from the flexible membrane and controlling the pressure applicator in such a way that the second force is applied to the flexible membrane.

3. The medical fluid pumping machine of claim 1 wherein the medical fluid cassette includes fluid inlet ports and fluid outlet ports that provide communication between the fluid passageway and an exterior of the medical fluid cassette, and

the processer is configured to close the fluid inlet ports and fluid outlet ports after controlling the pressure applicator in such a way that the first force is applied to the flexible membrane and before measuring the first pressure within the medical fluid cassette.

4. The medical fluid pumping machine of claim 1 wherein the medical fluid cassette includes fluid inlet ports and fluid outlet ports that provide communication between the fluid passageway and an exterior of the medical fluid cassette, and

controlling the pressure applicator in such a way that the first force is applied to the flexible membrane is performed with the fluid inlet ports and fluid outlet ports closed.

5. The medical fluid pumping machine of claim 1, comprising a vacuum source controllable by the processor and disposed within the compartment in a manner such that, when activated while the medical fluid cassette is within the compartment, the vacuum source is configured to apply a force to the flexible membrane, and

the processor is configured to change a spacing between the flexible membrane and the base by activating the vacuum source.

6. The medical fluid pumping machine of claim 5, wherein the processor is configured to change the spacing after controlling the pressure applicator in such a way that the first force is removed from the flexible membrane and before controlling the pressure applicator in such a way that the second force is applied to the flexible membrane.

7. The medical fluid pumping machine of claim 5, wherein the vacuum source is configured to apply a force to an outer surface of the flexible membrane.

8. The medical fluid pumping machine of claim 1 wherein controlling the pressure applicator in such a way that the first force is applied to the flexible membrane comprises controlling the pressure applicator in such a way that the flexible membrane is compressed against the base.

9. The medical fluid pumping machine of claim 8 wherein the pressure applicator comprises a piston configured to be advanced into and retracted from the compartment.

10. The medical fluid pumping machine of claim 8 wherein the medical fluid cassette includes fluid inlet ports and fluid outlet ports that provide communication between the fluid passageway and an exterior of the medical fluid cassette, and

controlling the pressure applicator in such a way that the first force is applied to the flexible membrane is performed with the fluid inlet ports and fluid outlet ports open.