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US4081372A Expired / Lapsed US ⏱️ 0.0 years remaining

Leakage indicator for recirculating peritoneal dialysis system

Assignee: University of Utah Research Foundation Inc
•
Filing: 1975-12-08
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Granted: 1978-03-28
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Expires: 1995-12-08
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Abstract

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.

Inventors

  • 👤 Curtis Lyman Atkin
  • 👤 Robert Longfield Stephen

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 12:15
CPC Classifications
A; A61; A61M; A61M1/00; A61M1/14; A61M1/28; A61M1/281; A61M1/16; A61M1/1692; A61M1/1694; A61M1/1696; A61M2205/00; A61M2205/70; A61M2205/705

Claims Analysis

Total Claims: 13
Claim 1
Independent Claim 103 words
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, 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.
Claim 2
Independent Claim 103 words
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, 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.
Claim 3
Dependent Claim 21 words
An apparatus as defined in claim 1, further comprising a means for in-process observation of coloration changes within said second solution.
Claim 4
Dependent Claim 23 words
An apparatus as defined in claim 1, further comprising a means for warning of the presence of hemolysate coloration of said second solution.
Claim 5
Dependent Claim 20 words
An apparatus as defined in claim 2, further comprising a means for warning of hemolysate coloration of said second solution.
Claim 6
Dependent Claim 64 words
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: 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.
Claim 7
Dependent Claim 64 words
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: 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.
Claim 8
Dependent Claim 26 words
An apparatus as defined in claim 5, further comprising a means for observing coloration of circulating nonsterile dialysis fluid immediately following exposure to said dialysis membrane.
Claim 9
Dependent Claim 23 words
An apparatus as defined in claim 5, further comprising a means for detecting and/or warning of hemolysate coloration within said nonsterile dialysis circuit.
Claim 10
Dependent Claim 40 words
An apparatus as defined in claim 6, wherein the observing means is a cuvet coupled into the nonsterile dialysis circuit to provide a longitudinal view down the length of the cuvet fluid path for increased sensitivity in detection of coloration.
Claim 11
Dependent Claim 30 words
An apparatus as defined in claim 6, wherein the observing means is an observation cell coupled into the nonsterile dialysis circuit to enable direct viewing of the circulating nonsterile fluid.
Claim 12
Dependent Claim 22 words
An apparatus as defined in claim 6, further comprising a means for warning of the hemolysate coloration within said nonsterile dialysis circuit.
Claim 13
Dependent Claim 16 words
An apparatus as defined in claim 7, wherein said detecting means is a photometric monitoring device.

References Cited (Backward Citations)

US3519572A Cited
US3802562A Cited
US3873467A Cited
US3900396A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1981-03-27 1981-09-26 1982-03-28 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1985-03-27 1985-09-26 1986-03-28 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1989-03-27 1989-09-26 1990-03-28 $7700.00 Window Closed / Lapsed

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