Integrated fiber optic sensor umbilical catheter
Inventors
Rehan, Virender • Delgado, Jesus
Assignees
Intelligent Optical Systems Inc • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
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Publication Number
US-11389095-B2
Publication Date
2022-07-19
Expiration Date
Abstract
Embodiments described herein relate to a catheter configured to detect at least one blood gas parameter present in blood in an artery of a patient, including, but not limited to, a catheter wall forming at least one lumen configured for umbilical arterial catheterization, at least one optical fiber incorporated in the catheter wall, wherein the at least one optical fiber is configured to detected the at least one blood gas parameter.
Core Innovation
The invention provides an Integrated Fiber Optic Sensor Umbilical (ISUM) catheter configured to detect at least one blood gas parameter present in blood in an artery of a patient. The catheter includes a catheter wall forming at least one lumen for umbilical arterial catheterization and a plurality of channels, each channel open on a side of the catheter wall along at least a portion of a length dimension of the catheter, with at least one optical fiber located in each channel. The open side of the catheter wall and each optical fiber are covered by a permeable membrane.
At least one blood gas parameter sensor is included in each optical fiber and configured to sense the at least one blood gas parameter, with the optical fibers comprising a plurality of optical fibers in each channel. Multiple optical fibers are tuned for respectively different blood gas parameters in the channels, enabling sensor arrays on sensitive segments of the optical fibers, including multiple sensing spots via wells along the sensitive segment. The permeable membrane and embedded sensorized channels support continuous, real-time monitoring in neonates while mitigating the wall effect through redundant oxygen sensing and processing.
In the measurement framework, emission-lifetime measurements are used for calibration-free operation, and a temperature sensing element can be included to detect temperature in the blood of the artery. The sensor outputs are combined into a single output, including combining redundant optical fiber outputs to determine blood gas parameters while filtering or omitting erroneous readings attributed to wall contact artifacts. The document further describes stabilizing sensor readings and continuity of detection while the catheter remains in the artery, with reported performance and safety assertions including correlation to gold-standard blood gas analysis.
Claims Coverage
The document includes three independent claims: catheter, making the catheter, and measuring blood gas parameters. Across these claims, the inventive coverage centers on side-open channels in an umbilical arterial catheter wall containing optical fibers covered by a permeable membrane, blood gas parameter sensors on optical fibers and sensitive segments, multiple optical fibers per channel tuned for respectively different blood gas parameters, and combining sensed outputs into a single output.
Side-open catheter channels with permeable membrane-covered optical fibers
A catheter comprising a catheter wall forming at least one lumen configured for umbilical arterial catheterization and a plurality of channels, each channel open on a side of the catheter wall along at least a portion of a length dimension of catheter; at least one optical fiber in each channel; and a permeable membrane covering the open side of the catheter wall and each optical fiber.
Optical-fiber blood-gas sensing with multiple parameter-tuned fibers in each channel
At least one blood gas parameter sensor included in each optical fiber and configured to sense the at least one blood gas parameter, wherein the at least one optical fiber comprises a plurality of optical fibers in each of the channels, including at least two optical fibers tuned for respectively different blood gas parameters in each of the channels.
Making a catheter with side-open channels and parameter-tuned optical fibers
A method for making a catheter comprising providing a catheter wall having at least one lumen configured for umbilical arterial catheterization and a plurality of channels open on a side of the catheter wall along at least a portion of a length dimension of catheter; providing at least one optical fiber in each channel; covering the open side of the catheter wall and each optical fiber with a permeable membrane; and providing at least one blood gas parameter sensor in each optical fiber configured to sense the at least one blood gas parameter, wherein providing the at least one optical fiber comprises providing a plurality of optical fibers in each of the channels including at least two optical fibers tuned for respectively different blood gas parameters in each of the channels.
Measuring blood gas parameters by sensorized optical-fiber sensitive segments and combined single output
A method for measuring one or more blood gas parameters comprising inserting into an artery of a patient a catheter with a catheter wall forming a plurality of channels each open on a side and containing at least one optical fiber in each channel and a permeable membrane covering the open side and each optical fiber, wherein a plurality of blood gas parameter sensors are arranged on a sensitive segment of the optical fiber; determining a sensed output from each of the plurality of blood gas parameter sensors; and combining the sensed output from each of the plurality of blood gas parameter sensors into a single output, wherein the at least one optical fiber comprises a plurality of optical fibers in each of the channels including at least two optical fibers tuned for respectively different blood gas parameters in each of the channels.
Overall, the independent claims collectively cover a catheter architecture with side-open channels and permeable membrane-covered optical fibers that carry blood-gas-parameter sensors on optical-fiber sensitive segments, with multiple optical fibers per channel tuned for different blood gas parameters, and a measuring method that determines sensor outputs and combines them into a single output.
Stated Advantages
Calibration-free operation using emission-lifetime measurements.
Mitigation of the wall effect by redundant oxygen sensors and filtering of wall-contact artifacts.
Continuous, real-time arterial blood gas monitoring in neonates.
Reduced blood draws and reduced catheter-related line infections, and reduced blood loss.
Faster intervention and improved correlation to gold-standard blood gas analysis.
Hemocompatibility with an absence of thrombogenicity.
Stable readings with improved precision and response time.
Documented Applications
Continuous, real-time arterial blood gas monitoring in neonates using an umbilical arterial catheterization approach.
Measurement of blood gas parameters in arterial blood by inserting the catheter into an artery of a patient and combining sensor outputs into a single output.
Clinical use cases aimed at reducing NICU blood draws and catheter-related line infections, and enabling early detection and faster intervention.
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