Validation techniques for fluid delivery systems

{
  "publication_number": "US9260741B2",
  "country": "US",
  "kind": "B2",
  "title": "Validation techniques for fluid delivery systems",
  "abstract": "A fluid delivery system may include a container that houses a medical fluid, a fluid pressurizing unit, and a fluid transfer set that transfers the medical fluid from the container to the fluid pressurizing unit. To validate the integrity and sterility of the fluid delivery system, the system may undergo testing protocols to evaluate the susceptibility of the system to pathogenic ingress, chemical degradation, and/or fluid cross-contamination between patient fluid delivery procedures. The testing protocols may help ensure that delivery system components used during multiple different fluid delivery procedures perform as well as if the components were replaced after each fluid delivery procedure.",
  "claims": [
    "1. A method comprising: providing a fluid delivery system that includes a medical fluid container, a fluid pressurizing unit, and a fluid transfer set, wherein the fluid transfer set is connected to transfer a fluid from the medical fluid container to the fluid pressurizing unit; drawing the fluid from the medical fluid container, through the fluid transfer set, and into the fluid pressurizing unit so that the fluid transfer set and fluid pressurizing unit are filled with the fluid; placing a discharge outlet of the fluid pressurizing unit in fluid communication with a fluid reservoir containing a tracking fluid, wherein the tracking fluid contains a tracking agent, and wherein the fluid reservoir is closed so that the fluid pressurizing unit cannot draw the fluid from the medical fluid container and discharge the fluid into the fluid reservoir; operating the fluid pressurizing unit so as to pressurize a portion of the fluid in the fluid pressurizing unit; extracting one or more samples of the fluid from at least one of the medical fluid container, the fluid transfer set, and the fluid pressurizing unit; and analyzing the one or more samples to determine a concentration of the tracking agent in the at least one of the medical fluid container, the fluid transfer set, and the fluid pressurizing unit.",
    "2. The method of claim 1, wherein the fluid transfer set comprises a polymeric tube that extends from a proximal end to a distal end and includes a bottle spike positioned on the proximal end of the polymeric tube and a mechanical connector positioned on the distal end of the polymeric tube.",
    "3. The method of claim 1, wherein the pressurizing unit comprises one of a syringe and a peristaltic pump.",
    "4. The method of claim 1, wherein the tracking agent is not present in the fluid from the medical fluid container and includes one of a dye, a bacterium, and a virus."
  ],
  "description_excerpt": "This disclosure relates to medical fluid containers and, more particularly, to medical fluid containers for medical fluid delivery systems.\n\nVarious medical procedures require that one or more medical fluids be injected into a patient. For example, medical imaging procedures oftentimes involve the injection of contrast media into a patient, possibly along with saline and/or other fluids. Contrast media can highlight features that would otherwise be less distinguishable from nearby tissue to help a clinician diagnose and treat a patient's medical condition. A patient is typically injected with contrast media before or during an imaging procedure and then exposed to radiation or electromagnetic energy to generate an image of the patient's body.\n\nWhen used, contrast media is usually injected into a patient by an automated injection system. The automated injection system may include a pump, syringe, or other fluid delivery device operatively connected to a catheter. The catheter is placed into a vein or artery of a patient. During operation, the fluid delivery device operates to pressurize the contrast media and to inject the media into the patient at a predetermined rate and volume.\n\nContrast media for an automated injection system can be supplied in a container sized to provide multiple doses of contrast media to multiple different patients or a container sized to provide a single dose of contrast media to a single patient.",
  "cpc": [
    "C12Q 1/22",
    "A61L 2/18",
    "A61L 2/28",
    "A61M 5/00",
    "A61M 5/1408",
    "A61M 5/1413",
    "A61M 5/14232",
    "C12Q 1/18",
    "G01M 3/2853",
    "G01N 2013/003",
    "G01N 31/226",
    "G01N 33/50",
    "Y10T 436/13"
  ],
  "ipc": [
    "C12Q 1/22",
    "G01N 31/22",
    "A61L 2/18",
    "A61L 2/28",
    "A61M 5/00",
    "A61M 5/14",
    "A61M 5/142",
    "C12Q 1/18",
    "G01N 33/50"
  ],
  "assignees": [
    "Bracco Imaging SpA"
  ],
  "inventors": [
    "Robert C. Williams, JR.",
    "Patrice Marchildon"
  ],
  "filing_date": "2013-12-05",
  "publication_date": "2016-02-16",
  "grant_date": "2016-02-16",
  "priority_date": "2012-12-05",
  "application_number": "US-201314097859-A",
  "family_id": "50825786",
  "cited_by_count": 12,
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}