Leakage indicator for recirculating peritoneal dialysis system
First Claim
1. An apparatus for the detection of leakage of a first, substantially colorless sterile solution from a closed system in parenteral administrations, said leakage to occur through an interface means separating said first solution from a second solution wherein the colorless state of the first solution makes visual detection of leakage or flow difficult or impossible, comprising:
- a. a source of hemolysate or other hemoglobin based indicator having strong coloration characteristics upon dilution into larger volumes of colorless solution, andb. means for introducing said hemolysate into the first solution in sufficient quantity to develop detectable color intensity upon leakage into said second solution.
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Abstract
Hemoglobin or hemolysate is used as an indicator for leakage detection in the dialysis membrane interface separating the sterile from the nonsterile circuitry in a recirculating peritoneal dialysis system. The indicator is dissolved in the steril dialysis fluid and is retained within the sterile circuit unless leakage occurs in the membrane. Upon rupture or other leakage in the membrane, fluid turbulance and pressure gradient cause crossflow between the sterile and nonsterile circuitry, endangering the patient with infection, peritonitis and endotoxin shock. Such crossflow is detected by the concurrent coloration caused by the mixing of hemoglobin indicator in the nosterile dialysis fluid.
97 Citations
11 Claims
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1. An apparatus for the detection of leakage of a first, substantially colorless sterile solution from a closed system in parenteral administrations, said leakage to occur through an interface means separating said first solution from a second solution wherein the colorless state of the first solution makes visual detection of leakage or flow difficult or impossible, comprising:
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a. a source of hemolysate or other hemoglobin based indicator having strong coloration characteristics upon dilution into larger volumes of colorless solution, and b. means for introducing said hemolysate into the first solution in sufficient quantity to develop detectable color intensity upon leakage into said second solution. - View Dependent Claims (2, 3, 4)
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5. In a recirculating peritoneal dialysis system having one or more sterile fluid circuits, one or more nonsterile fluid circuits and appropriate interfaces therebetween, an apparatus for the detection of dialysis membrane leakage, comprising:
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a. a source of hemolysate or other hemoglobin based leakage indicator having strong coloration characteristics, and b. means for introducing said hemolysate into a sterile circuit for marking sterile dialysis fluid. - View Dependent Claims (6, 7, 8, 9, 10, 11)
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Specification
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- Resources
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Current AssigneeUniversity of Utah Research Foundation (State of Utah)
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Original AssigneeUniversity of Utah (State of Utah)
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InventorsAtkin, Curtis Lyman, Stephen, Robert Longfield
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Primary Examiner(s)Spear, Jr., Frank A.
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Application NumberUS05/638,729Time in Patent Office841 DaysField of Search210/22, 210/321 B, 210/96 M, 210/94, 252/408, 23/230 B, 128/214 R, 128/214 B, 128/214 EUS Class Current210/94CPC Class CodesA61M 1/1692 Detection of blood traces i...A61M 1/1696 with dialysate regenerationA61M 1/28 Peritoneal dialysis ; Other...A61M 1/281 Instillation other than by ...A61M 2205/705 Testing of filters for leak...
