IP Library › Granted Patent US 11,660,032
Granted Patent B2
US 11,660,032 · App. 16/811,295 · Granted May 30, 2023

Catheter assemblies, oxygen-sensing assemblies, and related methods

Inventors: Natalie A. Silverton (Salt Lake City, UT); Kai Kuck (Park City, UT); Bradley J. Stringer (Kaysville, UT); Spencer B. Shumway (South Jordan, UT); Lars Lofgren (Salt Lake City, UT)
Assignees: SWSA Medical Ventures, LLC; University of Utah Research Foundation
A61B5/208A61B5/0261A61B5/14507A61B5/14552A61B5/14556A61B5/201A61M25/10A61B2560/0252A61M2205/0205
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Quick Facts
Patent No.
US 11,660,032
App. No.
16/811,295
Granted
May 30, 2023
Kind
B2
Abstract

An oxygen-sensing assembly for attachment to a urinary catheter may include a housing having a flow pathway extending between an inlet end and an outlet end thereof, an oxygen sensor in operable communication with the flow pathway of the housing, the oxygen sensor configured to detect oxygen levels of a fluid flowing through the flow pathway and a flowrate sensor configured to detect a flowrate of the fluid flowing through the flow pathway. A risk of acute kidney injury may be determined based on the mass flowrate of oxygen through the flow pathway, determined based on the detected oxygen levels and the flowrate of the fluid through the flow pathway. Related catheter assemblies and methods are also disclosed.

Claims (46)

1. A catheter assembly, comprising:

a urinary catheter comprising at least one lumen extending between an inlet end and an outlet end;

an oxygen-sensing assembly in fluid communication with the urinary catheter, the oxygen-sensing assembly comprising:

a housing having a flow pathway extending between an inlet end and an outlet end thereof, wherein the inlet end of the housing is attachable to the outlet end of the urinary catheter;

an oxygen sensor in operable communication with the flow pathway of the housing, the oxygen sensor configured to detect oxygen tension of a fluid flowing through the flow pathway; and

a flowrate sensor disposed between the oxygen sensor and the inlet end of the housing and configured to detect a flowrate of the fluid flowing through the flow pathway; and

a control system operably coupled to the oxygen sensor and the flowrate sensor, the control system comprising:

at least one processor; and

at least one non-transitory computer-readable storage medium storing instructions thereon that, when executed by the at least one processor, cause the control system to:

receive a detected oxygen tension and a detected flowrate of the fluid flowing through the flow pathway; and

based at least partially on the detected oxygen tension and the detected flowrate, determine a mass flowrate of oxygen of the fluid flowing through the flow pathway.

2. The catheter assembly of claim 1 , further comprising a temperature sensor, wherein the at least one non-transitory computer-readable storage medium is configured to cause the control system to compensate the detected oxygen tension of the fluid based on a temperature measured by the temperature sensor.

3. The catheter assembly of claim 1 , wherein the at least one non-transitory computer-readable storage medium is configured to cause the control system to determine a risk of acute kidney injury, medulla oxygenation, or both based on a real time value of one or more of an average value of the mass flowrate of oxygen, a standard deviation of the mass flowrate of oxygen, a median of the mass flowrate of oxygen, an interquartile range of the mass flowrate of oxygen, the maximum value of the mass flowrate of oxygen during a predetermined period of time, the minimum value of the mass flowrate of oxygen during the predetermined period of time, a volume of urine that has flowed through the flow pathway over a duration, arterial blood oxygenation, venous blood oxygenation, hemoglobin oxygenation, blood flowrate, and properties of the urinary catheter.

4. The catheter assembly of claim 1 , wherein the at least one non-transitory computer-readable storage medium is configured to cause the control system to determine the mass flowrate of oxygen in the fluid only when the fluid flows in a direction from the inlet end toward the outlet end.

5. The catheter assembly of claim 1 , wherein the at least one non-transitory computer-readable storage medium is configured to cause the control system to determine durations during which the fluid flowing through the flow pathway is in a direction from the outlet end to the inlet end and not to determine the mass flowrate of oxygen of the fluid during the durations.

6. The catheter assembly of claim 1 , wherein the control system is configured to correlate signals received from the oxygen sensor and the flowrate sensor in time.

7. The catheter assembly of claim 1 , wherein the control system is configured to determine a risk of acute kidney injury based on the mass flowrate of oxygen of the fluid flowing through the flow pathway.

8. The catheter assembly of claim 1 , wherein the oxygen sensor comprises one or more of a fiber-optic sensor, a Fiber Bragg grating sensor, and an electrochemical sensor.

9. The catheter assembly of claim 8 , wherein the oxygen sensor comprises:

an optical fiber extending at least partially into the housing of the oxygen-sensing assembly; and

a sensing portion comprising a dye-impregnated polymer excitable at a selected wavelength, the sensing portion disposed at least partially within the flow pathway of the housing and exposed to the fluid flowing through the flow pathway; and

a barrier between the optical fiber and the sensing portion and configured to prevent the optical fiber from contacting the fluid flowing through the flow pathway,

wherein the optical fiber is configured to transmit light through a distal end of the optical fiber and toward the sensing portion and to receive light from the sensing portion through the distal end of the optical fiber.

10. The catheter assembly of claim 1 , further comprising a user interface configured to provide an indication of a risk of acute kidney injury, a medulla oxygenation, or both of a patient based, at least partially, on the detected oxygen tension and the detected flowrate.

11. The catheter assembly of claim 1 , wherein the at least one non-transitory computer-readable storage medium is configured to cause the control system to determine a risk of acute kidney injury, medulla oxygenation, or both based on all of a concentration of oxygen of the fluid, the flowrate of the fluid, the mass flowrate of oxygen of the fluid, arterial blood oxygenation, venous blood oxygenation, hemoglobin oxygenation, blood flowrate of a patient, and properties of the urinary catheter.

12. An oxygen-sensing assembly for attachment to a urinary catheter, the oxygen-sensing assembly comprising:

a housing having a flow pathway extending between an inlet end and an outlet end thereof;

an oxygen sensor in operable communication with the flow pathway of the housing, the oxygen sensor configured to detect oxygen tension of a fluid flowing through the flow pathway;

a flowrate sensor disposed in the flow pathway and configured to detect a flowrate of the fluid flowing through the flow pathway; and

a control system operably coupled to the oxygen sensor and the flowrate sensor, the control system comprising:

at least one processor; and

at least one non-transitory computer-readable storage medium storing instructions thereon that, when executed by the at least one processor, cause the control system to determine a risk of acute kidney injury based, at least in part, on a mass flowrate of oxygen determined by the oxygen tension of the fluid and the flowrate of the fluid.

13. The oxygen-sensing assembly of claim 12 , wherein the oxygen sensor comprises one or more of a fiber-optic sensor and a Fiber Bragg grating sensor.

14. The oxygen-sensing assembly of claim 12 , further comprising a temperature sensor disposed downstream of the oxygen sensor and configured to detect a temperature of the fluid flowing through the flow pathway.

15. The oxygen-sensing assembly of claim 12 , further comprising a one-way valve disposed within the housing downstream from the oxygen sensor along the flow pathway.

16. A method, comprising:

attaching an oxygen-sensing assembly to a urinary catheter;

disposing the urinary catheter within a bladder of a subject;

detecting oxygen tension within a fluid flowing through the urinary catheter and through a flow pathway of a housing of the oxygen-sensing assembly with an oxygen sensor;

detecting a flowrate of the fluid flowing through the flow pathway with a flowrate sensor;

based at least partially on one or more of the detected oxygen tension and the detected flowrate of the fluid, determining a mass flowrate of oxygen of the fluid flowing through the flow pathway; and

based at least partially on the mass flowrate of oxygen of the fluid flowing through the flow pathway, determining a risk of acute kidney injury of the subject, determining medulla oxygenation of the subject, or both.

17. The method of claim 16 , further comprising positioning an additional oxygen sensor within a lumen of the urinary catheter.

18. The method of claim 16 , wherein based at least partially on the mass flowrate of oxygen of the fluid flowing through the flow pathway, determining a risk of acute kidney injury of the subject, determining medulla oxygenation of the subject, or both comprises determining one or both of the risk of acute kidney injury of the subject and medulla oxygenation of the subject based on all of a concentration of oxygen of the fluid, the flowrate of the fluid, the mass flowrate of oxygen of the fluid, arterial blood oxygenation, venous blood oxygenation, hemoglobin oxygenation, blood flowrate of a patient, and properties of the urinary catheter.

19. The method of claim 16 , wherein determining a risk of acute kidney injury of the subject comprises determining the risk of acute kidney injury of the subject based on one or more of an average mass flowrate of oxygen of the fluid, a standard deviation of the average mass flowrate of oxygen of the fluid, a median of the mass flowrate of oxygen of the fluid, arterial blood oxygenation, venous blood oxygenation, hemoglobin oxygenation, blood flowrate, and properties of the urinary catheter.

20. The method of claim 16 , wherein determining a mass flowrate of oxygen of the fluid flowing through the flow pathway comprises determining the mass flowrate of oxygen during durations of flow of the fluid flowing g through the urinary catheter in a direction from the urinary catheter to the oxygen-sensing assembly.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 6, 2020
From: SILVERTON, NATALIE; LOFGREN, LARS; KUCK, KAI
To: UNIVERSITY OF UTAH
Reel/Frame 052038/0855 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 6, 2020
From: SHUMWAY, SPENCER B.; STRINGER, BRADLEY J.
To: SWSA MEDICAL VENTURES, LLC
Reel/Frame 052038/0875 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 6, 2020
From: UNIVERSITY OF UTAH
To: UNIVERSITY OF UTAH RESEARCH FOUNDATION
Reel/Frame 052038/0937 →
Continuity (4)
Continuation In Part 16121372 · Sep 4, 2018
Provisional Application 62941449 · Nov 27, 2019
Provisional Application 62555161 · Sep 7, 2017
Related Publication 20200205718A1 · Jul 2, 2020
Cited By (1)
US 12,708,302