JP2019502422A - Pulse oximeter using disposable multi-material stretch bandage - Google Patents

Abstract

A customizable pulse oximetry assembly is disclosed. The assembly has a bandage comprising a first receptacle, a second receptacle, and a flexible connector connecting the first and second receptacles. The assembly also includes a light emitter that includes a first probe housing that removably attaches a light emitter to the first receptacle, and a light sensor that includes a second probe housing that is removably attached to the second receptacle. Have. A cable connector that physically couples the light emitter and the light sensor and communicatively couples the light emitter and the light sensor to a patient monitor is included as part of the assembly. The flexible connector, the first probe housing, and the second probe housing can be adjusted for separation and alignment between the light emitter and the light sensor according to the dimensions of the patient's body part.

Description

  The present invention generally relates to pulse oximetry assemblies. More particularly, the present invention relates to a pulse oximetry assembly having a flexible connector and receptacle for mounting a light emitter and a light sensor.

  Pulse oximetry is an effective and non-invasive method of monitoring and obtaining a patient's oxygen saturation (SpO2) level and perfusion index. Pulse oximetry requires illumination of the patient's blood perfused tissue using a light source of one or more wavelengths. Spectroscopy is then used to determine the change in oxygen saturation. This can give an indication of the patient's condition.

  Because of the way pulse oximetry acquires light-based physiological data, it maximizes the amount of desired detection signal and ensures alignment of the luminescent and detection elements to minimize the contribution of the detected signal This is very important.

  To align the light emitting and detecting elements, pulse oximeters typically use clip-on devices made of rigid materials. These ensure placement or attachment to the patient's body part, but the clip-on device cannot accommodate patient bodies of significantly different sizes. A flexible oximeter device has advantages over clip-on-pulse oximeters in terms of suitability for use with various sized patient body parts. Nevertheless, the light emitting and light detecting elements remain difficult to align in flexible oximeter devices.

  For example, one US patent application publication discloses a flexible oximetry assembly to mitigate the undesirable effects of patient movement on oximeter readings. The flexible oximeter includes an elastic sensor body that is disposed between the emitter and the detector and includes a reinforcing member that stabilizes a distance between the emitter and the detector. The reinforcing member is configured to bend to establish a certain distance between the emitter and the detector.

  As a further example, U.S. Pat. No. 8,706,179 discloses a disposable dressing device having a probe emitter receptacle and a probe detector receptacle for removably attaching an emitter and a detector, respectively. The apparatus also includes a biasing member to ensure alignment between the emitter and detector.

  There is a need in the art for a pulse oximeter assembly that can be adjusted to ensure separation and alignment between a light emitter and a light sensor while addressing the dimensions of a patient's body part. Yes.

  A first embodiment of the present invention relates to a customizable pulse oximetry assembly that connects a bandage comprising a first receptacle and a second receptacle to the first receptacle and the second receptacle. And a flexible connector. The assembly includes a light emitter including a first probe housing that removably attaches a light emitter to the first receptacle, and a light sensor including a second probe housing that is removably attached to the second receptacle. Have. The assembly further includes a cable connector that physically couples the light emitter and the light sensor and communicatively couples the light emitter and the light sensor to a patient monitor. The flexible connector, the first probe housing, and the second probe housing are configured to adjust the separation and alignment between the light emitter and the light sensor according to the dimensions of the patient's body part.

  The second embodiment of the present invention includes a method of attaching a light emitter having a first probe housing and an optical sensor having a second probe housing to a bandage. The bandage includes a first receptacle for the first probe housing, a second receptacle for the second probe housing, and a flexible connector that connects the first receptacle to the second receptacle. The bandage is stretched through a flexible connector to accommodate the dimensions of the patient's body part. The bandage is attached to the patient's body part. The bandage may be adjusted so that the light emitter and the light sensor are aligned. Photosensor data is then acquired using the photoemitter and photosensor. The data can then be transmitted to the patient monitor via the cable connector.

FIG. 5 shows a customizable pulse oximetry assembly. FIG. 3 shows a pulse oximetry assembly in a contracted state. FIG. 2 shows a pulse oximetry assembly in an extended state to accommodate the physical dimensions of a patient's body part. FIG. 6 illustrates a method for measuring pulse oximeter data using the pulse oximetry assembly of the present invention. FIG. 5 shows a pulse oximetry assembly attached to a small finger. FIG. 5 shows a pulse oximetry assembly attached to a large finger. 1 shows a pulse oximetry assembly 100 attached to an infant's foot.

  The accompanying drawings, which are included to provide a further understanding of the invention, are incorporated herein to illustrate embodiments of the invention. Together with the description, the drawings also serve to explain the principles of the invention.

  The following are definitions of terms used in various embodiments of the present invention.

  As used herein, the term “receptacle” refers to a structural element for mounting a light emitter or light sensor. The receptacle may include a rigid element (eg, metal, glass or rigid polymer), a flexible element (eg, polymer or rubber), or any combination thereof.

  As used herein, the term “flexible connector” refers to a physical connector for connecting two receptacles and adjusting the separation and orientation between the two receptacles. The flexible connector can be a wire, mesh, polymer, a series of pivotally connected segments, or any combination thereof, which can be stretchable or contractible in length.

  As used herein, the term “bandage” refers to an assembly that includes two receptacles connected by a flexible connector.

  As used herein, the term “probe housing” refers to a housing that encloses a light emitter or light sensor. The probe housing is flexible and can further be used to attach a light emitter or light sensor to the receptacle. The probe housing is flexible including a material such as a polymer sheath and a metal or polymer configured as a wire, mesh, plate, or any configuration that is flexible and structurally stable upon bending. Can have an internal substance.

  The term “cable connector” as used herein refers to a cable that physically connects a light emitter and a light sensor and communicatively connects the light emitter and light sensor to an external device such as a patient monitor. The cable connector can be a Y-shaped cable, with one end connected to an external system and the other end with a Y branch connected to the light emitter and light sensor. The cable connector can be a USB cable that can transmit data packets and power from one end of the cable to the other. The cable connector may be an optical fiber cable.

  With the above definitions in mind, pulse oximetry is a method of measuring the oxygen saturation of a patient's blood. Blood oxygen saturation is a measure of the amount of oxygen carried by hemoglobin in the bloodstream. Saturation is usually expressed as a percentage rather than an absolute value.

  For example, blood oxygen saturation levels measured immediately after birth can provide a good indicator of general health. A level of less than 75% may indicate that the newborn may have some abnormality. In order to determine the patient's condition, blood oxygen saturation should be expressed as a percentage of total hemoglobin saturated with oxygen. An acceptable normal range for healthy patients is in the range of 95 to 99%.

  The pulse oximeter according to the present invention includes an electronic processor and two or more small light emitting diodes (LEDs) or series of LEDs that face the photodiodes in a translucent part of the patient's body. This is usually applied to the fingertip or earlobe. One of the LEDs emits light in the red part (red LED) of the visible part of the electromagnetic spectrum, and the other LED emits light in the infrared part. The amount of light absorbed at these two wavelengths varies significantly between oxygen-enriched and oxygen-deficient blood, and oxygenated hemoglobin absorbs more infrared light and more red light passes through. Make it possible to do. Deoxygenated hemoglobin allows more infrared light to pass through and absorbs more red light. Oxyhemoglobin and its deoxygenated form have significantly different absorption patterns.

  In operation, the LEDs of the present invention are alternately turned on / off and then both turned off for a predetermined time. This alternation and termination allows an optical sensor, such as a photodiode, to respond separately to red and infrared light and correct the light detected due to ambient light. This is measured when both LEDs are off and is used as a baseline or reference signal. The amount of light transmitted (ie, not absorbed) is measured and separate normalized signals are generated for each wavelength.

  These signals change over time. This is because the amount of arterial blood present increases with each heartbeat. By subtracting the minimum transmitted light from the peak transmitted light at each wavelength, the effects of other tissues and materials (including venous blood, skin, bone, muscle, fat, nail polish) are usually constant over a period of time. It can be corrected in that it absorbs an amount of light. The ratio of the measured red light to the measured infrared light is calculated by the processor. This ratio, which represents the ratio of oxidized hemoglobin to deoxygenated hemoglobin, is then converted by the processor into a measure of oxygen saturation level.

  The light emitter of the present invention is a light emitting diode, photodiode, phototransistor, photoemitter, or any other that can emit light at one or more wavelengths and change the intensity and duration of the emitted light. The type of light emitting element may be used. The light sensor may be a photodetector, a photoelectric receiver, a photodiode, or any other sensor that can detect light with one or more wavelengths or intensities. The patient monitor transmits operational data and receives operational data between the light emitter and the optical sensor via the cable connector. The operational data can include wavelength, light intensity, duration, and sampling rate.

  The light emitter and the light sensor each include a probe housing for attaching the light emitter or light sensor to a respective receptacle. The probe housing can be configured to establish sufficient contact with the patient's body part. The probe housing can also be physically manipulated to allow alignment of the light emitters and light sensors and to otherwise conform to the shape of the surface of the patient's body part to which they are attached. . One form of physical manipulation involves bending the probe housing to conform to the shape of the surface of the patient's body part. For example, a patient's body part can have a relatively flat surface. As a result, the probe housing is also configured to be flat. On the other hand, another patient's body part can be curved. As a result, the probe housing is bent to conform to the curved surface.

  The probe housing preferably incorporates one or more perforations to allow light to pass from the light emitter to the photosensor with minimal intensity loss. Alternatively, the probe housing can completely enclose the light emitter or light sensor. In such embodiments, the housing is preferably optically transparent at the wavelength at which the light emitter and light sensor operate.

  The patient monitor of the present invention includes a processor, a display, a user interface, and a memory. The patient monitor further includes a communication module that transmits or receives data with an external system via a wireless or wired connection. The patient monitor can also include a cable connector port for connecting the cable connector to the patient monitor.

  The patient monitor can perform the function of transmitting and receiving data between the light emitter and the light sensor via the cable connector. The monitor can not only receive input from the user via the user interface, but can also process data, store data, and display data. The monitor can also communicate with devices such as cloud servers, hospital servers, mobile devices, or external systems such as desktop computers.

  FIG. 1A shows a customizable pulse oximetry assembly 100. As shown in FIG. 1A, the assembly includes a bandage 108 having a flexible connector 110 connected to a cable connector 102, a light emitter 104, a light sensor 106, and receptacles 112 and 114. The light emitter 104 and light sensor 106 of FIG. 1A are attached to receptacles 112 and 114, respectively. The flexible connector 110 can be stretched, contracted, or distorted to fit the dimensions of the patient's body part. FIG. 1B shows the pulse oximetry assembly 100 in a contracted state. FIG. 1C shows the pulse oximetry assembly 100 in an extended state to accommodate the physical dimensions of the patient's body part.

  The bandage 108 includes two receptacles 112 and 114 and a flexible connector 110 that connects the two receptacles 112 and 114. Receptacles 112 and 114 can be used to attach light emitter 104 and light sensor 106. The flexible connector 110 allows separation of the light emitter 104 and the light sensor 106 and alignment adjustment.

  Receptacles 112 and 114 further include attachments for securing light emitter 104 and light sensor 106 to receptacles 112 and 114. The receptacle may incorporate any one or more of attachment means such as velcro, magnet, fastener, screw, clamp, clip, hook, pocket, strap, suction cup, pin, hole, and snap. Other means for realizing the attachment can also be used.

  In one embodiment, the aforementioned attachment is located on the underside of the receptacle. As a result, the light emitter and light sensor are in direct contact with the patient's body part. In another embodiment, the attachment is located outside the receptacle. As a result, the light emitter and the light sensor are attached to the outside of the receptacle via the attachment. In embodiments where the receptacle is opaque and the light emitter and light sensor are mounted outside the opaque receptacle, a window is constructed through the receptacle so that light from the light emitter passes through the patient's body part and the patient's body part. To the optical sensor.

  The flexible connector is preferably made of a material that, when stretched as shown in FIG. 1C, does not snap back to the original configuration shown in FIG. 1B. The flexible connector can include a metal wire or wire mesh that can be bent to assume a variety of configurations. The physical operation of the flexible connector and probe housing, such as bending, stretching, twisting, contracting, tensioning, or any combination thereof is reversible in the preferred embodiment.

  The flexible connector can include a lightweight casing or sheath that protects the flexible connector. The flexible connector is preferably made of one or more materials that are strong and non-toxic. For example, the flexible connector can include a metal wire wrapped in a rubber casing. Alternatively, the flexible connector includes a wire mesh confined within a plastic sheath. The choice of casing can be based on aesthetics or form factor. The medical facility or institution can design the casing to include a label or other useful information such as the manufacturer name, hospital, or date of manufacture of the pulse oximetry assembly.

  The flexible connector can also include a plurality of inflexible sub-elements connected by a hinge or similar connector. As a result, the plurality of inflexible sub-elements are collectively flexible, as can occur with a series of rigid segments pivotally interconnected in a continuous manner. The series of rigid segments may be bent into a horseshoe shape with varying curvature. The pivots of the individual sub-elements can further provide a degree of rigidity to maintain the bending configuration set by the medical personnel. As a result, the pivot provides sufficient rigidity to the interconnected sub-elements and allows them to retain the overall shape regardless of the physical strain or operation in question. The number of rigid segments used in the flexible connector can vary based on one or more dimensions of the patient's body part.

  In one embodiment, the flexible connector can have a corrugation. As a result, extending or contracting the flexible connector results in the corrugated flexible connector contracting, expanding, unfolding, and folding. As a result, at least a portion of the corrugated ridges and grooves overlap to substantially match the size of the patient's body part. At least some portions of the corrugations can have velcro-type hooks and loops to prevent unfolding of the folded corrugated flexible connector.

  The bandage flexible connector and the two receptacles may be integrated so that the flexible connector cannot be removed from the two receptacles. Alternatively, the flexible connector and the receptacle may be removable from each other. A removable or replaceable flexible connector can allow a high degree of customization. This is because the user can replace the flexible connector or receptacle as necessary.

  For example, a user can replace a short flexible connector with a longer flexible connector, or replace a long flexible connector with a shorter flexible connector. The user can also replace a worn or contaminated flexible connector with a new or sterile flexible connector. Conversely, a user can replace a worn or contaminated receptacle with a new or sterilized flexible connector.

  FIG. 2 illustrates a method for measuring pulse oximeter data using the pulse oximetry assembly of the present invention. The light emitter and light sensor are first attached to a bandage that includes a flexible connector (step 202). To fit the shape and size of the patient's body part, the assembly is stretched through a flexible connector (step 204) and attached to the patient's body part used for pulse oximetry measurements (step 206). The assembly is adjusted so that the attachment is stable, the light emitters and light sensors are aligned and in contact with the patient's body part (step 208). Acquisition of pulse oximetry data is initiated by actuating the light emitter and the light sensor to obtain light sensor data (step 210). The acquired optical sensor data is then transmitted to the patient monitor via the cable connector for storage or further processing (step 212).

  3A-3C illustrate various embodiments of customizable pulse oximetry assemblies for use with various patient body parts. FIG. 3A shows the pulse oximetry assembly 100 attached to a small finger 302. FIG. 3B shows the pulse oximetry assembly 100 attached to a larger finger 304. FIG. 3C shows the pulse oximetry assembly 100 attached to the infant's foot 306. The pulse oximetry assembly of the present invention can also be used on other patient body parts such as ears, forehead, nose and toes.

  In an exemplary use in connection with the present invention, three patients are brought to the emergency room. The first patient is a 10 year old child, the second patient is an adult male, and the third patient is an infant. The health care professional prepares the pulse oximeter assembly by attending to the first patient, selecting the bandage first, and attaching the light emitter and light sensor to the bandage. The bandage is then applied to the child's finger. The bandage is adjusted to fit the shape and size of the child's fingers. Thereafter, the health professional measures the blood oxygen saturation level of the child.

  After the measurement, the healthcare worker attends a second patient. Health care workers use the same pulse oximetry assembly for adult patients. The pulse oximetry assembly is first wiped with a disinfectant and then the flexible connector is extended to accommodate a second patient body part, such as a finger. This finger will be larger than the first patient. Thereafter, pulse oximeter data is measured.

  The health care worker then performs pulse oximetry measurements on the infant patient. The health care professional decides to use the same light emitter and light sensor after disinfection, but uses a new bandage for the infant to minimize infection. Thereafter, the medical staff extends the flexible connector to fit the infant's foot, and acquires the infant's pulse oximetry data.

  After acquiring each pulse oximeter data, the health professional transfers the acquired data to the desktop computer in the emergency room to display and process the acquired data. The healthcare professional views various data on the desktop computer, analyzes the data, reaches a diagnosis, and enters findings and comments into each patient record. The used pulse oximetry assembly element can be discarded or sterilized for reuse in another patient.

  The pulse oximetry assembly can include flexible electronic elements such as flexible displays, flexible power sources, flexible light sources, and flexible sensors. In one embodiment, both the light sensor and the light emitter are flexible to facilitate adjustment when fitting the pulse oximetry assembly to the patient's body part. In another embodiment, the receptacle can include a flexible display that provides a visual indication, such as a flexible OLED display, to indicate the degree of alignment of the light emitter and light sensor. The light emitter and light sensor may be powered by a flexible battery embedded in the bandage receptacle.

  The present invention is not limited to the several exemplary embodiments of the invention described above. Other variations envisioned by those skilled in the art are also intended to be included within the scope of the present disclosure.

Claims (15)

Customizable pulse oximetry assembly,
A bandage comprising a first receptacle and a second receptacle;
A flexible connector connecting the first receptacle and the second receptacle;
A light emitter including a first probe housing removably attaching the light emitter to the first receptacle;
An optical sensor including a second probe housing removably attached to the second receptacle;
A cable connector for physically coupling the light emitter and the light sensor and further communicatively coupling the light emitter and the light sensor to a patient monitor;
The flexible connector, the first probe housing, and the second probe housing are adjusted for separation and alignment between the light emitter and the light sensor resulting from dimensions of a patient's body part;
The pulse oximetry assembly, wherein the first receptacle, the second receptacle, and the flexible connector are individually removable.   The assembly of claim 1, wherein the light emitters alternate in operation for a predetermined period of time.   The assembly of claim 1, wherein the light sensor is responsive to both red and infrared light.   The assembly of claim 1, wherein the light sensor corrects ambient light.   The assembly of claim 1, wherein the light emitter is selected from the group comprising an LED, a photodiode, a phototransistor, and a photoemitter.   The assembly of claim 1, wherein the light emitter operates at one or more wavelengths.   The assembly of claim 1, wherein the probe housing is flexible.   The assembly of claim 1, wherein the probe housing includes one or more perforations that allow transfer of light from the emitter to the sensor.   The assembly of claim 8, wherein the probe housing is optically transparent at at least one wavelength, wherein the at least one wavelength is a wavelength at which the light emitter operates.   At least one of the receptacles includes one or more attachments selected from the group comprising velcro, magnet, fastener, screw, clamp, clip, hook, pocket, strap, suction cup, pin, hole, or snap; The assembly of claim 1.   11. The assembly of claim 10, wherein the attachment is disposed under the receptacle to allow direct contact of the light emitter and the light sensor with a patient body part.   The assembly of claim 10, wherein the attachment is disposed outside the receptacle and the light emitter and the light sensor can be externally attached.   The assembly of claim 1, wherein the receptacle is opaque and includes a window that allows light to pass from the light emitter through the patient body part and from the patient body part to the light sensor.   The assembly of claim 1, wherein the flexible connector includes a series of hinges.   The assembly of claim 14, wherein the hinges are pivotably and sequentially interconnected to allow manipulation into a horseshoe configuration.

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