Hemoglobin display and patient treatment

Inventors

Al-Ali, AmmarKiani, Massi Joe E.O'Reilly, Michael

Assignees

Masimo Corp

Publication Number

US-12318580-B2

Publication Date

2025-06-03

Expiration Date

2030-05-19

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Abstract

The present disclosure describes embodiments of a patient monitoring system and methods that include the measure and display of hemoglobin statistics. In an embodiment, total hemoglobin trending is displayed over a period of time. Statistics can include frequency domain analysis, which may be unique for each patient monitored. The total hemoglobin trending and/or statistics can further be used to help control the treatment of a patient, such as being used to control IV administration.

Core Innovation

The invention provides a patient monitoring system and methods for the measurement, display, and analysis of hemoglobin concentration in living patients, particularly focusing on total hemoglobin (tHb). The system includes a noninvasive sensor with a light emitter and detector designed to gather physiological data from a patient, and processors capable of continuously determining a series of hemoglobin concentration measurements over time from a selected tissue site. This enables the real-time tracking of fluctuations in hemoglobin concentration, which was previously thought to be relatively constant.

Addressing the limitations of standard pulse oximeters, which cannot measure the amount of hemoglobin or detect other molecules binding to it, this system allows continuous, noninvasive monitoring of hemoglobin and related metrics. The patient monitor displays both the current and historical trends of hemoglobin concentration, providing caregivers with visual data and trend analysis. The system is further capable of performing frequency domain analysis, such as a fast Fourier transform, to detect unique or patient-specific patterns in hemoglobin variability.

The device also integrates the capability to control or influence patient treatments, like dialysis or intravenous (IV) administration, based on the hemoglobin measurements. By connecting with devices such as dialysis machines or IV controllers, the system can regulate treatments in response to real-time hemoglobin trends, potentially reducing overuse of treatments and assisting in maintaining hemoglobin within a desired range. The system’s ability to analyze hemoglobin signatures also aids in diagnosing hemoglobin or red blood cell abnormalities, such as sickle cell anemia and Thalassemia.

Claims Coverage

The patent contains three independent claims, each outlining inventive features focusing on the noninvasive, continuous measurement of hemoglobin concentration, integration with systems for patient treatment, and physiologic trend or condition analysis.

Noninvasive, continuous hemoglobin concentration monitoring system with real-time control capability

A system comprising: - A first system with an arterial line to connect to a patient. - A second system with a non-invasive sensor including a light emitter and detector, connected to the patient’s tissue site. - Hardware processors that determine a plurality of hemoglobin concentration measurements continuously over time based on responses from the tissue site. - The first system operates in response to the continuous plurality of hemoglobin concentration measurements.

Patient monitoring method for continuous, noninvasive hemoglobin measurement and system control

A method comprising: 1. Continuously determining, noninvasively, a plurality of hemoglobin concentration measurements over time from a patient’s tissue site, using a light emitter and detector to obtain measurements. 2. Controlling a system (with an arterial line connected to the patient) in response to these continuous hemoglobin measurements.

Processor-controlled system for noninvasive, continuous hemoglobin measurement with treatment system interface

A system where one or more hardware processors are configured to: - Determine, noninvasively, multiple hemoglobin concentration measurements continuously over time from a patient tissue site (via response to light emitter and detector). - Control a system with an arterial line to the patient, responsive to the continuous plurality of hemoglobin concentration measurements.

In summary, the inventive features provide a comprehensive patient monitoring solution that enables continuous, noninvasive measurement of hemoglobin, utilizes this data to control patient treatment devices, and facilitates advanced analysis for determining patient conditions.

Stated Advantages

Provides continuous, noninvasive measurement and trending of total hemoglobin, enabling detection of fluctuations that help caregivers determine patient condition and guide appropriate treatment.

Facilitates real-time analysis, including frequency domain analysis, to identify patient-specific hemoglobin variability signatures, aiding in diagnosis of conditions like sickle cell anemia and Thalassemia.

Enables automated or semi-automated control of treatment systems, such as dialysis or IV fluid administration, resulting in more efficient intervention and potential reduction of unnecessary or excessive treatments.

Allows noninvasive screening for hemoglobin and red blood cell abnormalities, potentially reducing the need for invasive and time-consuming laboratory blood tests.

Documented Applications

Monitoring and controlling dialysis treatments by providing hemoglobin level feedback to dialysis machines for automated regulation during dialysis sessions.

Controlling IV administration, including the rate or amount of IV fluids, drugs, blood, plasma, or nutrition based on continuous hemoglobin measurement.

Screening and diagnosis of hemoglobin and red blood cell function abnormalities, such as sickle cell anemia and Thalassemia, through analysis of hemoglobin variability patterns over time.

Detection of physiological changes or abnormalities in vessel fluid volume, permeability, or spleen function by monitoring hemoglobin concentration trends and patterns.

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