Disposable components for reusable physiological sensor
Inventors
Al-Ali, Ammar • Lamego, Marcelo • Litchfield, Jim • Olsen, Gregory A.
Assignees
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Publication Number
US-12408869-B2
Publication Date
2025-09-09
Expiration Date
Abstract
A sensor cartridge according to embodiments of the disclosure is capable of being used with a non-invasive physiological sensor. Certain embodiments of the sensor cartridge protect the sensor from damage, such as damage due to repeated use, reduce the need for sensor sanitization, or both. Further, embodiments of the sensor cartridge are positionable on the user before insertion in the sensor and allow for improved alignment of the treatment site with the sensor. In addition, the sensor cartridge of certain embodiments of the disclosure can be configured to allow a single sensor to comfortably accommodate treatment sites of various sizes such as for both adult and pediatric applications.
Core Innovation
The invention provides disposable sterile barriers configured to interpose a material between a tissue site and surfaces of a reusable optical sensor that transmits optical radiation into the tissue site and generates a signal responsive to the optical radiation after attenuation by pulsatile blood flow. The disposable sterile barrier comprises a collapsible tube or an elongate tube having substantially optically transparent material so that the barrier is interposed between the tissue site and an emitter-adjacent surface and between the tissue site and a detector-adjacent surface. The barrier is sized to receive the reusable optical sensor, with portions including an open end and a closed end to position the barrier proximate the reusable optical sensor surfaces.
In one form, the barrier includes a collapsible tube sized such that a first portion with an open end receives the reusable optical sensor and is configured to be interposed proximate an emitter of the reusable optical sensor, and a second portion with a closed end receives the reusable optical sensor and is configured to be interposed proximate a detector of the reusable optical sensor. The collapsible tube is configured to be interposed during application of the reusable optical sensor to urge emitter and detector housings against opposite sides of a tissue site while making physiological measurements without direct contact between the tissue site and the reusable optical sensor. A fastener may be used to close or seal the barrier around a sensor cable to maintain the sterile barrier at a cable entry.
The invention further includes an optical sensing method of non-invasively measuring constituents of pulsatile blood flow within a tissue site without substantial risk of nosocomial infection by direct contact between a reusable optical sensor and the tissue site. The method applies a substantially transparent barrier configured to be interposed between the tissue site and the first housing and between the tissue site and the second housing upon application of the reusable optical sensor. The disposable sterile barrier may be sized for a tissue site including at least a portion of a finger, and separate disclosed embodiments include light-bounce reduction using absorptive cartridge materials and/or connecting portions bridging gaps around emitter/detector apertures to improve measurement accuracy and calibration.
Claims Coverage
The document includes three independent claims (1, 5, and 9) focused on a disposable sterile barrier for reusable optical sensors and a non-invasive optical sensing method that uses such a barrier, plus a particular disposable sterile barrier structure using an elongate optically transparent tube and a cable-sealing fastener. Across these claims, the core inventive features center on optically transparent disposable barriers that interpose between a tissue site and emitter/detector surfaces, and on barrier geometry (collapsible tube or elongate cavity tube) and sealing around a sensor cable to support non-invasive measurements with reduced nosocomial infection risk.
Disposable sterile barrier with collapsible tube interposed at emitter and detector surfaces
A disposable sterile barrier configured to interpose a material between a tissue site and surfaces of a sensor configured to transmit optical radiation into the tissue site and to generate a signal responsive to the optical radiation after attenuation by pulsatile blood flow within the tissue site, wherein the disposable sterile barrier comprises a barrier comprising a collapsible tube made of a substantially optically transparent material; a first portion including an open end sized to receive a reusable optical sensor, configured to be interposed between the tissue site and a first surface of the reusable optical sensor proximate an emitter; and a second portion including a closed end sized to receive the reusable optical sensor, configured to be interposed between the tissue site and a second surface of the reusable optical sensor proximate a detector.
Non-invasive optical sensing method using a substantially transparent barrier interposed between tissue and sensor housings
An optical sensing method of non-invasively measuring constituents of pulsatile blood flow within a tissue site without substantial risk of nosocomial infection by direct contact between a reusable optical sensor and the tissue site, comprising providing a reusable optical sensor with an emitter in a first housing and a detector in a second housing in communication with a sensor cable, urging the housings against opposite sides of the tissue site, transmitting optical radiation into the tissue site and receiving attenuated optical radiation to generate signals for a monitor, and applying a barrier so that physiological measurements are made without direct contact between the tissue site and the reusable optical sensor, wherein the barrier is interposed between the tissue site and the first housing and between the tissue site and the second housing upon application, the barrier comprises material substantially transparent so as not to substantially distort the physiological measurements, and the barrier further comprises a collapsible tube comprising a first portion with an open end sized to receive the reusable optical sensor and a second portion with a closed end sized to receive the reusable optical sensor.
Disposable sterile barrier with elongate optically transparent tube cavity and cable-sealing fastener
A disposable sterile barrier comprising an elongate tube comprising a cavity, an open end, and a closed end, where the open end comprises an opening large enough to accommodate a reusable optical sensor, the cavity is sized to fully enclose the reusable optical sensor and at least a portion of a sensor cable extending from the optical sensor, the elongate tube comprises a material substantially optically transparent, and a fastener disposed proximate the open end configured to seal the open end of the elongate tube around the sensor cable.
Across independent claims 1, 5, and 9, the claims cover disposable sterile barriers that are made of substantially optically transparent material and are configured to interpose between a tissue site and reusable optical sensor emitter/detector surfaces (collapsible tube embodiments) while enabling optical measurement of pulsatile blood flow. The claims also cover a non-invasive optical sensing method that uses such barriers to avoid direct contact with the tissue site and reduce nosocomial infection risk, and a specific disposable barrier structure using an elongate optically transparent tube cavity enclosing the reusable optical sensor and at least a portion of a sensor cable with a fastener sealing the open end around the cable.
Stated Advantages
Non-invasively measuring constituents of pulsatile blood flow within a tissue site without substantial risk of nosocomial infection by direct contact between a reusable optical sensor and the tissue site.
Making physiological measurements without direct contact between the tissue site and the reusable optical sensor.
Barrier interposed while comprising material substantially transparent so as not to substantially distort the physiological measurements.
Documented Applications
Non-invasive optical sensing in which a reusable optical sensor having an emitter and detector in communication with a sensor cable is applied to a tissue site, with a disposable sterile barrier used to allow physiological measurements without direct contact between the tissue site and the reusable optical sensor.
Use of the tissue site including at least a portion of a finger for the non-invasive optical sensing method.
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