Optical detection of intravenous infiltration

Inventors

Winchester, Jr., Leonard W.Chou, Nee-Yin

Assignees

IVWatch LLC

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Publication Number

US-7826890-B1

Patent

Publication Date

2010-11-02

Expiration Date


Abstract

An intravenous infiltration detection apparatus for monitoring intravenous failures, which applies an optical method coupled with fiber optics and algorithms for tissue optics to provide a means for noninvasive detection of intravenous infiltration surround the site of IV injection. In the invention, the tissue surrounding the injection site is exposed to a single-wavelength of electromagnetic radiation, and light is collected with only one detector. Changes in the relative intensity of the radiation reflected, scattered, diffused or otherwise emitted provide a means for monitoring infiltration. The invention provides routine, automated, continuous, and real-time monitoring for patients undergoing IV therapy.

Core Innovation

The invention provides an intravenous infiltration detection apparatus for a patient by directing non-encoded continuous single wavelength light in a certain spectral range through a first disposable light guide fixed in a disposable sensor on the patient’s tissue near an IV site. A second disposable light guide fixed in the disposable sensor collects light reflected, scattered, diffused or otherwise emitted from the patient’s tissue near an intravenous needle injection site. A detector at the proximal end of the second light guide detects the received light, and an analyzer in the electronics unit analyzes the received light by comparing intensity of the received light.

A disposable skin contact sensor holds the distal ends of the first and second light guides against the patient’s tissue, enabling monitoring of light near the IV infusion site. The analyzer provides information on the occurrence of infiltrations by comparing intensity of the received light before and during IV infusion. An indicator connected to the analyzer in the electronics unit provides information and/or an alarm indicative of tissue infiltration.

The monitoring includes comparing intensity differences between received light before infusion and during infusion at a preselected level, with the collected light received from areas near the directed light. The claims further define that receiving the collected light includes receiving the collected light from areas near the directed light, and that alarm triggering is based on a preselected level of differences in the collected light received at the present time and a baseline. In some implementations, intensity comparisons are ambient light compensated and may use ratio-based comparisons involving ambient light signal value.

Claims Coverage

The document includes three independent claims (apparatus, method, and intravenous infiltration detection method). Across these independent claims, the inventive features are centered on non-encoded continuous single wavelength light, two disposable fiber-based light guides held by a disposable skin-contact sensor, detection and analyzing intensity changes before and during IV infusion, and providing an indicator/alarm when a preselected level of intensity change is reached (optionally ambient-compensated and ratio-based).

Continuous single-wavelength non-encoded illumination via disposable light guide near IV site

Directing non-encoded continuous single wavelength light in a certain spectral range from a single light source through a first disposable light guide into the patient’s tissue near an IV site.

Disposable fiber light guide for collecting reflected/scattered/diffused/emitted tissue light

Collecting light reflected, scattered, diffused or otherwise emitted from the patient’s tissue via a second disposable light guide for receiving the electromagnetic radiation.

Detector and analyzer comparing intensity before and during infusion

Detecting the light at a detector and providing an analyzer for analyzing received light by comparing intensity of the received light, including comparing intensity of light received before and during infusion against a baseline.

Indicator and alarm based on preselected differences in collected light

Providing an indicator that provides information on the occurrence of infiltrations, and providing an alarm indicative of tissue infiltration upon a preselected level of differences in collected light received at the present time and a baseline.

Disposable skin-contact sensor fixing the distal ends to patient tissue

Providing a disposable skin contact sensor fixed to and holding the distal ends of the first and second light guides against the patient’s tissue near the IV infusion site, including mounting the skin-contact sensor to the tissue for attachment.

Digitizing and storing detector signals during infusion analysis

Digitizing, analyzing, and storing signals from the detector at the analyzer, followed by providing an indicator and indicating changes in intensity based on preselected level of changes.

Ambient-compensated comparison and ratio-based significant change threshold

Comparing intensity using a baseline and during-infusion comparison that is ambient light compensated, including comparing a ratio of ambient-compensated light received before infusion versus ambient light and ambient-compensated light received during infusion versus ambient light to a preselected level.

Across the independent claim set, the coverage centers on an IV infiltration detection system that uses non-encoded continuous single wavelength illumination delivered by a first disposable fiber light guide, tissue-light collection by a second disposable fiber light guide, detection with a proximal detector and intensity comparison by an analyzer, and an indicator/alarm triggered when intensity differences (optionally ambient-compensated and ratio-based) exceed a preselected level, with both guides held against tissue by a disposable skin contact sensor.

Stated Advantages

Provides an alarm indicative of tissue infiltration based on preselected differences in collected light received before and during infusion.

Documented Applications

Monitoring tissue infiltration during IV infusion by directing non-encoded continuous single wavelength light near an IV site, collecting tissue light, comparing intensity against a baseline, and providing an alarm for tissue infiltration.

Detecting intravenous infiltration using a disposable skin-contact sensor holding illumination and collection light guides against a patient’s tissue near an IV infusion site, with an indicator to provide information on the occurrence of infiltrations.

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