SpO2 sensor with partitioned electronics

Abstract

A sensing device for acquiring data from a finger. The device includes a carrier plate having a stacked portion having a finger side and a cover side. A tip wing extends from the stacked portion and wraps around the finger. Electronic components coupled to the carrier plate include a first circuit board located on the cover side of the stacked portion and one or more optical components electrically located on the tip wing. The optical components are configured to emit light toward the finger and detect the light from the finger. The carrier plate is electrically coupled to the electronic components to acquire the data from the finger. A power system is located between the cover side and the finger side of the carrier plate, wherein the power system supplies power to the electronic components via the carrier plate. A cover secures the carrier plate to the finger.

Description

[0001] Cross-reference of related applications

[0002] This invention claims priority to U.S. Patent Application Serial No. 17 / 094,328, filed November 10, 2020, entitled “SpO2 SENSOR HAVING PARTITIONED ELECTRONICS”. Technical Field

[0003] This disclosure generally relates to SpO2 sensors with partitioned electronics, and more specifically to single-use SpO2 sensors with partitioned high-pitch and low-pitch electronics. Background Technology

[0004] Pulse oximetry is a known patient monitoring procedure in the art for measuring oxygen saturation in the bloodstream, and specifically, a non-invasive measurement. Specifically, a pulse oximeter is a device configured to measure peripheral oxygen saturation (SpO2) in a patient's bloodstream, which can provide valuable information about the patient's health. Exemplary sensors known in the art can be classified as reflective or transmissive sensor types. In each case, the pulse oximeter emits light (typically two wavelengths) through a body part, such as a finger or toe, whereby the light is subsequently detected by a photodetector. Different materials absorb light at different rates at different wavelengths. Therefore, for example, since oxygen in the bloodstream absorbs light differently than other materials such as skin, bone, muscle, fat, and fingernails, the detected light can be used to determine peripheral oxygen saturation. In a transmissive configuration, the light-transmitting device and the photodetector are positioned on opposite sides of the body part, for example, where the light passes directly through the finger or toe. Conversely, a reflective pulse oximeter detects light reflected back from the body part, or in other words, where the photodetector is not on the side of the body part opposite the emitter.

[0005] For pulse oximeters to be accurate, it is important that the device is configured to make good contact with the body part. Similarly, it is important to block ambient light so that the light detected at the photodetector effectively comes only from the emitter. Summary of the Invention

[0006] This summary is provided to introduce a series of concepts that will be further described in the detailed embodiments below. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to help limit the scope of the claimed subject matter.

[0007] One embodiment of this disclosure generally relates to a sensing device for acquiring data from a finger. The device includes a carrier plate having a stacked portion having a finger side configured to face the finger, a cover side opposite the finger side, and a connector side located between the finger side and the cover side. A tip wing extends from the stacked portion and is configured to wrap around the tip of the finger, and the carrier plate has an outer side and an opposing inner side. Electronic components are electrically coupled to the carrier plate, including a first circuit board electrically coupled to the carrier plate on the cover side of the stacked portion, and one or more optical components electrically coupled to the tip wing of the carrier plate. The optical components are configured to emit light toward and detect the light from the finger, and the carrier plate is electrically coupled to the electronic components to acquire the data from the finger. A power system is located between the cover side and the finger side of the carrier plate, and the power system provides power to the electronic components via the carrier plate. A cover is configured to secure the carrier plate to the finger.

[0008] Another embodiment typically relates to a sensing device for enabling a sensing device to acquire data from a finger. The method includes positioning a battery within a housing to form a power system, and electrically coupling electronic components to a carrier plate. The carrier plate has a stacked portion and a tip wing extending therefrom, wherein the tip wing is configured to wrap around the tip of the finger, and wherein the carrier plate has an outer side and an opposing inner side. The electronic components include a first circuit board coupled to the stacked portion and one or more optical components coupled to the tip wing. The one or more optical components are configured to emit light toward and receive light from the finger. The carrier plate electrically couples the electronic components to acquire the data from the finger. The method also includes attaching a cover to the carrier plate, the cover being configured to secure the carrier plate to the finger. The method further includes wrapping the stacked portion of the carrier plate around the power system to form a finger side configured to face the finger, a cover side opposite the finger side, and a connector side located between the finger side and the cover side. The power system supplies power to the electronic component via the carrier plate, and the carrier plate electrically couples the electronic component to acquire the data from the finger.

[0009] Another embodiment typically involves an SpO2 sensing device that can be attached to a finger. The device includes a carrier plate of a single, integrally formed material, wherein the carrier plate has a stacked portion having a finger side configured to face the finger, a cover side opposite the finger side, and a connector side located between the finger side and the cover side. A tip wing extends from the stacked portion and is configured to wrap around the tip of the finger. The carrier plate has an outer side and an opposing inner side. The electronic component is electrically coupled to the carrier plate. The electronic component includes: a first circuit board electrically coupled to the carrier plate on the cover side of the stacked portion, the first circuit board providing wireless communication for the device; a light emitter coupled to the tip wing of the carrier plate and configured to emit light toward the finger; a light receiver coupled to the tip wing of the carrier plate and configured to detect the light from the finger, wherein the light emitter and the light receiver are positioned on the carrier plate so as to be on opposite sides of the finger in use; and a second circuit board electrically coupled to the carrier plate on the finger side of the stacked portion, wherein the second circuit board controls the light emitter and the light receiver. The carrier plate electrically couples the electronic component to determine SpO2 data from the finger based on the light detected by the light receiver. A power system is sandwiched between the cover side and the finger side of the stacked portion of the carrier plate, wherein the power system supplies power to the electronic component via the carrier plate. A cover is configured to secure the carrier plate to the finger.

[0010] Various other features, objects, and advantages of this disclosure will become apparent from the following embodiments, taken in conjunction with the accompanying drawings. Attached Figure Description

[0011] This disclosure is described with reference to the following figures.

[0012] Figure 1 This is an isometric top view of an exemplary sensor device disposed on a patient's finger according to the present disclosure;

[0013] Figure 2 and Figure 3 They are Figure 1 Top and bottom views of parts of the device shown;

[0014] Figure 4 It is possible Figures 1 to 3 A top view of the exemplary carrier plate provided in the illustrated embodiment;

[0015] Figure 5 Such as can be combined in Figures 1 to 3 The decomposed isometric view of the power system in the implementation plan;

[0016] Figure 6 It is similar to Figure 1 The implementation scheme shown is a breakdown isometric view before being attached to the patient;

[0017] Figure 7 It is along Figure 6 Line 7-7 is similar to the one cut in the middle. Figure 6 The illustrated cross-sectional side view of the embodiment; and

[0018] Figure 8 This is an exemplary control system that can be incorporated into a sensor device according to the present disclosure. Detailed Implementation

[0019] Through experimentation and development, the inventors have recognized several issues with the usability and quality and accuracy of the generated data in SpO2 sensor devices currently known in the art. In particular, the inventors have recognized the importance of configuring the SpO2 sensor to be securely attached to body parts such as the fingers, which improves light transmission and helps reduce detection by ambient light. The challenge of achieving good attachment is further exacerbated as SpO2 devices become wireless, allowing patients to become more mobile and active. The inventors have also recognized the further emergence of issues regarding the durability of disposable detectors used for extended periods (in some cases 72 hours or longer). In these extended durations, periodic removal of the sensor is often necessary, such as when the patient washes their hands. However, the inventors have recognized that sensor devices currently known in the art do not readily detach and reattach themselves. Adhesives begin to fail and / or the wrapping material becomes damaged, resulting in poor adhesion to the skin, which leads to reduced comfort and decreased quality of the output data.

[0020] Regarding sensor devices known in the art, the inventors have recognized the following drawbacks. Some sensors are configured as reusable "rubber sleeve" types. However, the inventors have recognized that these devices are physically heavy due to the use of thick elastomers, leading to patient discomfort and poor data. Fixation to the finger is also insufficient because these rubber sleeve type sensors do not fit well across a wide range of patient body types (e.g., finger size), which can vary considerably due to factors such as weight, gender, and age. In addition to poor fixation or pressure on the finger, the rubber sleeve style also suffers from poor breathability, again reducing data output due to excessive sweating and further worsening the fixation.

[0021] Clip-on sensors also exist, but they are mechanically complex and therefore unsuitable for disposable devices (e.g., GE). TruSignal finger sensor TS-FD).

[0022] Bandage-type disposable sensors have also become common, typically consisting of a textile-like wrapping with an adhesive surface for bonding to the skin (e.g., GE). The TruSignal adult adhesive-wrapped sensor TS-AAW). These designs tend to lose adhesion when detached and reattached. Additionally, the wrappers of currently known devices are typically narrow and offer only minimal ambient light attenuation. GE Healthcare manufactures an aircraft-type disposable sensor (e.g., GE...). The TruSignal TS-AP adult / child sensor, with its wing that wraps around the fingertip and two identical side wings that wrap around the finger, is difficult to apply and maintain controlled pressure on the finger when it provides good coverage and good ambient light attenuation.

[0023] As will become apparent, the currently disclosed sensor devices address many of the aforementioned problems and offer further improvements for single-use sensors. In these sensors, the disclosed sensors are configured to be securely (but adjustablely) attached to the finger and remain effective despite being attached and detached several times during extended use periods (e.g., 72 hours or longer). The disclosed sensors provide sufficient pressure on the fingertip for optimal performance and also offer good attenuation of ambient light.

[0024] The inventors have recognized that attenuation has become more problematic as patients increasingly use mobile devices while being monitored by SpO2 sensing devices. In this situation, a significant amount of light can be emitted from these mobile devices near the SpO2 sensing device, affecting the accuracy of the output data, since not all detected light originates from the patient. Furthermore, the disclosed sensor is lightweight, provides minimal amounts of materials for disposal, refurbishment, and / or recycling (e.g., batteries), and is breathable to prevent excessive sweating.

[0025] It should be understood that while this disclosure primarily relates to SpO2 devices, the devices and methods disclosed herein are also applicable to other devices connected to a subject (not limited to humans, but also including, for example, animals), and are not limited to placement on the fingers (e.g., the wrist, arm, ankle, leg, toe, or entire foot of a newborn). For example, the disclosed methods and devices are suitable for disposable blood pressure monitoring, blood glucose monitoring, drug delivery infusion devices, and other medical or non-medical devices. Similarly, while this disclosure generally relates to communication with wireless devices, wired configurations are also contemplated.

[0026] Figure 1An exemplary embodiment of the sensing device 10 according to this disclosure is depicted. As shown, the entire system 1 includes a sensing device 10 for acquiring SpO2 data from a patient's finger 9. The sensing device 10 communicates with a central receiver 2 via a wireless communication device and an antenna 131 in a manner known in the art. For example, the wireless communication may be via... Wi-Fi or other long-range, short-range, or medium-range wireless protocols known in the art may be used. In the example shown, the central receiver 2 has a display 4 and a controller 6, and communicates with the sensing device 10 via a wireless connection 8 between the two.

[0027] The sensing device 10 extends from the tip side 11, aligned with the tip of the finger 9, to the knuckle side 13, and to the left side 15 and right side 17. The top 12 is oriented above the finger 9, and the opposite bottom 14 is oriented below the finger. The sensing device 10 is held in place on the finger 9 by a cover 20 (also referred to as a covering), which will be discussed further below. A cover 70 extends above the cover 20 and houses at least a portion of the electronic components for the sensing device 10, which will be discussed further below. The cover 70 provides space for these electronic components to extend above the cover 20 while also protecting them from moisture, impact, and / or other damage or interference.

[0028] Figure 2 and Figure 3 Depicted from the top and bottom views respectively Figure 1 The sensing device 10 comprises a cover 20 and a cover 70, in which no electronic components are installed. The cover 20 has an outer side 22 opposite to the finger side 24, whereby the finger side 24 is configured to contact the patient's finger 9 in use. The cover 20 is formed by a central portion 30 having a length 31 and a width 33 and defining a central opening 36 therein. A tip wing 40 having a spherical part 47 and a protrusion 49 extends from the central portion 30 of the cover 20. The tip wing 40 is configured to wrap around the tip of the finger 9 such that a portion of the protrusion 49 remains above the finger (e.g., on the fingernail), wherein the spherical part 47 is opposite to the portion of the protrusion 49 on the underside of the finger 9. The tip wing 40 has a basal end 42 and a distal end 44 extending 41 between them, and also has widths 43A, 43B corresponding to the protrusion 49 and the spherical part 47. It should be understood that although the sphere 47 has a wider width 43B than the width 43A of the protrusion 49, this is not necessary, and other configurations are contemplated in this disclosure. The wrapping 20 may be formed of materials currently known in the art, including, for example, woven or nonwoven fabrics, films, tapes, or foams.

[0029] Similarly, Figure 2 and Figure 3As shown, the first wing 50 and the second wing 60 also extend from the central portion 30 in directions opposite to each other. In the illustrated embodiment, the first wing 50 has a basal end 52 and a distal end 54, extending a length 51 between them. The first wing 50 has widths 53A and 53B, and is shown as protrusions extending from the central portion 30 away from the tip wing 40 spaced approximately 90° apart. Similarly, the second wing 60 has a basal end 62 and a distal end 64, extending a length 61 between them. The second wing 60 has widths 63A and 63B, similar to the widths 53A and 53B of the first wing 50, tapering downwards as the second wing 60 and the first wing 50 extend away from the central portion 30. The inventors have recognized that wrapping the wrapper 20 around the finger 9 on three sides, as currently shown, is particularly effective in attenuating ambient light and securing the device.

[0030] It should be understood that while this disclosure focuses primarily on wraps having three wings that wrap around a finger, other numbers of wings are also contemplated, whether for a subject's finger or other body parts. For example, other embodiments of this disclosure include two side wraps without pointed wings, a single side wrap attached to itself (with or without pointed wings), and other configurations (e.g., multiple side wings similar to a butterfly bandage, with or without pointed wings), for instance.

[0031] exist Figure 2 and Figure 3 In one embodiment, adhesive 196 is disposed on the finger side 24 of the wrapping 20, particularly on the second wing 60, to help secure the sensing device 10 to the finger 9. This embodiment is further characterized by additional adhesive 196 disposed on the central portion 30, as discussed further below. In addition to these adhesives 196, Figure 2 and Figure 3 An attachment system is depicted including a first attachment portion 210 and a second attachment portion 220, the first attachment portion and the second attachment portion being configured to releasably engage with each other, the first attachment portion and the second attachment portion being, in this example, hook and loop fasteners (e.g., The first attachment portion 210 is attached to the finger side 24 of the package 20, particularly to the first wing 50, and in this example is the "ring" portion of the attachment system because this side faces the patient's finger 9. Similarly, the second attachment portion 220 is attached to the outer side 22 of the package 20, particularly to the second wing 60, and in this case forms the "hook" of the engaging ring. It should be recognized that different types of fasteners (e.g., "touch" fasteners or...) The “double-locking” fastener can be used as the first attachment portion 210 and the second attachment portion 220, and the positions of these first attachment portions 210 and the second attachment portions 220 can be alternated.

[0032] exist Figure 2 and Figure 3 In the example shown, the first attachment portion 210 has a tip side 211, a knuckle side 213, a left side 215, and a right side 217. The outer side 212 is configured to engage with the second attachment portion 220, and the inner side (unlabeled) is configured to be attached to the package 20, for example, using an adhesive. Exemplary adhesives available commercially include double-coated polyethylene tape, acrylic adhesive tape, and other adhesives known in the art. Similarly, the second attachment portion 220 extends between the tip side 221 and the knuckle side 223, and between the left side 225 and the right side 227. The outer side 222 is configured to engage with the first attachment portion 210 in the aforementioned manner, and the inner side (unlabeled) is configured to be attached to the package 20 in a secure manner.

[0033] In addition to using adhesives, by providing an attachment system with a first attachment portion 210 and a second attachment portion 220, the inventors have realized that the sensing device 10 can be reattached multiple times without diminishing its ability to hold the sensing device 10 to the finger 9. In some examples, the adhesive 196 disposed between the sensing device 10 and the finger 9 is configured to generally provide friction against translation and rotation of the sensing device 10 relative to the finger 9, while pressure on the finger 9 is provided in an adjustable manner through the engagement of the first attachment portion 210 and the second attachment portion 220.

[0034] Because the attachment system provided by the first attachment portion 210 and the second attachment portion 220 does not require adhesion to the skin, durable and highly reusable materials, such as hook and loop fasteners, can be combined to provide hundreds or even thousands of reuses to accommodate pressure regulation, etc. The first attachment portion 210 and the second attachment portion 220 also allow patients to frequently remove the sensing device 10 for purposes such as handwashing. In particular, given the COVID-19 pandemic, the inventors have recognized that the ability to frequently wash hands without hindering the removability of the sensing device 10 or eliminating the need for frequent replacement of the sensing device is far more advantageous than systems currently known in the art. In short, the inventors have recognized that the “adhesive” type of fixation from the adhesive, together with the non-adhesive secondary attachment system (the first attachment portion 210 and the second attachment portion 220), provides a combined beneficial effect greater than the sum of the individual parts.

[0035] Still refer to Figure 2 and Figure 3The sensing device 10 includes a cover 70 having an outer side 20 facing away from the finger 9 and an inner side 74 facing the finger 9. The cover 70 extends in length 71 and width 73 such that an internal volume 80 is disposed therein for holding a portion of the electronics used to operate the sensing device 10, discussed further below. In the illustrated example, the edge 82 of the cover 70 is permanently or semi-permanently attached to the package 20 in a watertight manner via a welding area 83, which can be welded using laser welding or other types of welding known in the art. Other methods for attaching the cover 70 to the package 20 include, for example, adhesives or integral formation of both. For example, the cover 70 may be formed of a plastic or ceramic material to provide waterproof and impact protection for the component held therein. In some embodiments, the cover 70 is made of, for example, ABS plastic, polycarbonate, polyamide PA6, and / or polyamide PA66.

[0036] In some embodiments, the welded area 83 where the cover 70 meets the wrapping 20 forms a transmission boundary through which light generated within the cover 70 can be seen from the outside by the patient or caregiver. For example, the welded area 83 (which does not need to be welded, but is referred to for simplicity) can be made of polycarbonate, clear acrylic, and / or fiber optic materials, through which the light indicator 156 ( Figure 7 (Discussed below) Position it close enough that part or all of the transmission boundary emits light.

[0037] In some embodiments, the cover 70 is removable (e.g., via a razor blade cutting the welding area 83) to servicing and / or replacing the electronic components held therein, such as replacing the battery before returning the device to (new) service. In this way, a new cover 70 can then be re-attached or re-welded to the package 20, allowing the disposable sensing device 10 to be refurbished for a variety of uses. In some examples, additional steps are also involved in the refurbishment process, including, for example, sterilization and application of a new adhesive 196 for contact with a new patient's skin, and application of a new temporary backing sheet.

[0038] Figure 2 The illustrated embodiment depicts light openings 86 disposed within the cover 70, which serve as LED or other light indicators within the internal volume 80 of the cover 70 (see...). Figure 7The 156 apertures provide visibility so that the sensing device 10 is visible from the outside. Specifically, these apertures 86 can be used to transmit the status of the pairing process between the sensing device 10 and the central receiver 2, the power status, the communication status, or the battery level of the sensing device 10, and / or provide an indication of the current SpO2 level being detected by the sensing device 10. For example, different colors can represent different states (green for high battery power, yellow for medium battery power, red for low battery power), flash and / or pulse at different rates during the pairing process or other operations, or combinations of these characteristics, for example.

[0039] exist Figure 6 In the illustrated embodiment, the cover 70 also defines venting openings 84 therein, which in this example allow gas exchange between the internal volume 80 of the cover 70 and the ambient air. In the case of zinc-air batteries, this is discussed further below; these venting openings 84 also provide the necessary oxygen for the chemical reactions of these batteries, while still being limited to a size sufficient to prevent moisture from entering the cover 70 and damaging the electronic components therein. In particular, the inventors have recognized that the venting openings 84 can be specifically sized to allow heat and airflow to occur, but the surface tension of water and other liquids prevents such moisture from passing through the venting openings 84.

[0040] Figure 4 An electronic system 90 for operating the sensing device 10 is described. Figure 6 An exemplary carrier plate 100 is shown within the sensing device 10. The carrier plate 100 is shown in a flat configuration before being formed and installed within the sensing device 10. Specifically, the carrier plate 100 has a central portion 110 configured to substantially align with the central portion 30 of the package 20. A tip extension 112 extends from the central portion 110 and is configured to substantially align with the tip wing 40 of the package 20. Side extensions 114, including a connector 116 and a shelf 118, also extend from the central portion 110, whereby the side extensions 114 are configured to fold or roll into a stacked portion 120. Figure 6 This will be discussed below. A notch 111 is formed in the central portion 110 and serves as a strain relief element for the side protrusion 114.

[0041] exist Figure 4 In the illustrated embodiment, the tip extension 112 and the side extension 114 extend approximately 90° apart from the central portion 110. Generally, the support plate 100 extends between the tip side 101 and the knuckle side 103, and between the left side 105 and the right side 107. As per... Figure 6 The folding pattern will be more obvious as shown, with the support plate 100 having an outer side 102 opposite to the inner side 104. Fold lines 106 depict the locations where the support plate 100 of this embodiment is folded or rolled up, such as... Figure 6 As will become apparent, the carrier plate 100 is configured such that the power system 140 ( Figure 5 It can be held inside the inner side 104 of the support plate 100, specifically within the stacked portion 120.

[0042] Figure 5 An exemplary power system 140 is depicted, such as one that can be incorporated within an electronic system 90 to power a sensing device 10. Figure 5 The power system 140 includes a housing 142 defining a receiver 143 configured to receive one or more batteries 144. A spring 146 is configured such that the battery 144 contacts an upper contact 148 and a lower contact 152, which are anchored to the housing 142 via anchors 150 and 154, respectively, in a manner known in the art. In some embodiments, the housing 142 is made of a rigid material such as plastic to provide sufficient strength to support the spring 146, the upper contact 148, and the lower contact 152.

[0043] As discussed above and as... Figure 6 As shown, the power system 140 is configured to be received within a cavity 121 defined within the stack portion 120, which is formed by folding the side protrusion 114 in a manner previously discussed. This provides space savings due to the greater density of the electronic system 90, and also provides isolation between components within the electronic system, as discussed below. The power system 140 is electrically coupled to the carrier plate 100 in a manner known in the art.

[0044] Figure 6 The sensing device 10 is depicted as layers that provide the aforementioned features and functionality, but also provide efficient fabrication and watertight sealing for the electronic components therein. The uppermost layer shown is the previously discussed enclosure 20 (including the cover 70), which may include an adhesive on the underside of the central portion 30 for attachment to the next layer, in this case, the first sealing layer 160. It should be understood that while this example shows a first sealing layer 160 and a second sealing layer 170, more or fewer sealing layers can be used, and therefore different configurations are contemplated in this disclosure. In some embodiments, the sealing layers are made of foam material. Exemplary materials for constructing the sealing layers include Avery. Vancive 2120U+3M1774W and / or NMC TA-100+3M 1522 medical tape.

[0045] exist Figure 6In the example shown, the first sealing layer 160 is configured to substantially overlap the central portion 30 of the package 20. The first sealing layer 160 extends between the tip side 161 and the knuckle side 163, and between the left side 165 and the right side 167. The outer side 162 is configured to be attached to the package, such as via the first sealing layer 160, the package, or both, with an adhesive 168. The finger side 164 is opposite the outer side 162, and in some embodiments, this outer side may also be provided with an adhesive 168 for adhesion to the carrier plate 100, which may be the same as or different from the adhesive on the outer side 162 and / or the package 20. The first sealing layer 160 defines an opening 166 therethrough, which in this example includes a notch 169. This opening 166 is configured to receive at least a portion therein of the stacked portion 120 of the carrier plate 100. The notch 169 is provided in the opening 166 of the first sealing layer 160 for general alignment with the stacked portion 120 of the carrier plate 100, thereby enabling the carrier plate 100 and the first sealing layer 160 to be centered and aligned.

[0046] Still refer to Figure 6 The stacked portion 120 of the carrier plate 100 is defined as having a cover side 122, a finger side 124, and a connector side 126 between them. At least a portion of the stacked portion 120 is received within the cover 70 via an opening 166 extending through the first sealing layer 160. As previously discussed, the electrical system 140 (not shown) may be incorporated within the cavity 121 of the stacked portion 120. Additionally, a first circuit board 132 is electrically coupled to the carrier plate 100 and positioned on its shelf 118. In this way, the first circuit board 132 is also configured to be held within the cover 70 during assembly.

[0047] In some examples, the substrate 100 is copper etched on one or both sides of a polyimide (PI) film, for example, about 0.2 mm thick. In other examples, the substrate 100 is formed of polyethylene (PET) or thermoplastic polyurethane (TPU). The traces can be printed on it, for example, using silver ink.

[0048] In some embodiments, the first circuit board 132 is configured to provide a wireless connection between the sensing device 10 and the central receiver 2. The first circuit board 132 includes a microcontroller unit (MCU), radio circuitry (RFID), a power management unit (PMU), and an antenna. For example, the electronic circuitry may be a separate or monocrystalline silicon (e.g., nRF52) component, or packaged in a single hybrid component. In some examples, the first circuit board 132 is approximately 10 mm × 10 mm and approximately 0.5 mm thick. The first circuit board 132 may be constructed of FR4 with etched copper traces, and may be, for example, 4 or 6 layers thick, as is known in the art. In some examples, the component pitch is tight, as low as 0.4 mm. Large pads approximately 1 mm thick may be used on the non-component side to bond the first circuit board 132 to the carrier plate 100. The bonding between the first circuit board 132 and the carrier plate 100 may be accomplished by soldering (e.g., for PI) and / or by conductive adhesives such as silver-epoxy resin or anisotropic conductive film (ACF) (e.g., for PET or TPU).

[0049] It should be understood that these dimensions are merely exemplary and not a limitation of the invention.

[0050] The second circuit board 136 is also electrically coupled to the carrier board 100. However, unlike the first circuit board 132, which is disposed on the cover side 122 of the stacked portion 120, the second circuit board 136 is coupled to the finger side 124 of the stacked portion 120. In some embodiments, the second circuit board 136 is configured to control the optical components 138 and process data received therefrom, which is further transmitted to the first circuit board 136. In some embodiments, the second circuit board 136 includes analog front-end (AFE) components and optical components. One such example of an AFE is an analog device such as the ADPD106 or AD80396 known in the art, which includes an LED driver, an amplifier, and an AD converter. For example, the AFE may communicate with a microcontroller unit (MCU) on the first circuit board 132 via a serial data bus (such as SPI or I2C).

[0051] It should be understood that the specific configuration of the components between the first circuit board 132 and the second circuit board 136 is not fixed, but can be configured in various ways. By providing another non-limiting example, the PMU, AFE, and MCU are located on the second circuit board 136, while the RFID and antenna are located on the first circuit board 132. In some examples, the RFIC is a hybrid circuit including the MCU, RF, and antenna.

[0052] In other examples, redundant MCUs can be avoided by including an AFE on the second board 136 and a single-chip MCU / RF on the first board 132. The antenna may reside on the first board 132 or may be implemented as part of other structures (e.g., on the carrier board 100 or printed on the cover 70). In this configuration, the PMU may reside on either the first board 132 or the second board 136 (the latter potentially providing improved measurement noise performance).

[0053] On the outer side 102 of the support plate 100 (although not within the stack portion 120 in this example), an optical component 138 for emitting and / or receiving light to detect the patient's SpO2 level is also coupled. In the illustrated example, the optical component 138 includes an emitter 137 and a separate receiver 139, as previously discussed, which are configured to be positioned on opposite sides of the finger 9 in use such that light is emitted through them. For example, the optical component 138 may be selected from optical components currently known in the art, or from other optical components that emit light, receive light, or both emit and receive light.

[0054] An exemplary transmitter 137 available on the market is the Osram SFH 7016. Similarly, an exemplary receiver 139 is the Osram BPW 34S-Z or SFH 2200. However, it should be understood that these optical components 138 are merely exemplary, and other optical components 138 are also contemplated in this disclosure.

[0055] In some embodiments, the carrier plate 100 and one or more electronic components 130 coupled thereto are overmolded to protect the assembly, which can then serve as a replaceable sub-component for refurbishment, etc.

[0056] like Figure 6As shown in the embodiment, a second sealing layer 170 is disposed below a carrier plate 100 and, in some examples, attached to the carrier plate via an adhesive 184, which may be disposed on the sealing layer 170 and / or the carrier plate 100. The second sealing layer 170 extends between the tip side 171 and the knuckle side 173, and between the left side 175 and the right side 177. The second sealing layer 170 is attached to the carrier plate 170 and, in some places, directly attached to the finger side 164 (on its outer side 172) of the first sealing layer 160. The finger side 174 is opposite the outer side 172, and an opening 176 is defined to extend through the second sealing layer 170. The opening 176 is configured to substantially receive a second circuit board 136 therein. In particular, the second circuit board 136 is defined to have a height H1, and in the illustrated embodiment, the height H2 of the second sealing layer 170 is configured to be at least as high as the height H1 of the second circuit board 136. The inventors have chosen to provide a second sealing layer 170 having a height H2 that is at least as high as the height H1 of the second circuit board 136, such that when the sensing device 10 is positioned on the finger 9, the patient cannot feel any electronics extending from the finger side 124 of the second circuit board 136.

[0057] The sensor opening is also defined within the second sealing layer 170. In this example, the transmitter opening 178 is aligned with the transmitter 137 and the receiver opening 179 is aligned with the receiver 139. Figure 6 In the example shown, the heights of the transmitter 137 and receiver 139 are less than the height H1 of the second circuit board 136, and therefore the height H1 of the second sealing layer 170 is such that the patient cannot feel the transmitter 137 and / or receiver 139 when the sensing device 10 is positioned on the finger 9. This allows light emitted from the transmitter 137 and received by the receiver 139 to pass unobstructed through the second sealing layer 170. This configuration also seals off ambient light by defining the transmitter opening 178 and receiver opening 179 within the material of the second sealing layer 170.

[0058] exist Figure 6In the illustrated embodiment, a protective layer is also provided to protect the integrity of the transmitter 137 and receiver 139, particularly when there are direct transmitter openings 178 and receiver openings 179 penetrating the second sealing layer 170. In the illustrated example, coating 180 is disposed on a base 182, which can be adhered to the finger side 174 of the second sealing layer 170 using an adhesive such as described above. In other examples, coating 180 may be disposed directly within the transmitter openings 178 and / or receiver openings 179, or in other words, overlap with these openings. For example, silicone droplets may be positioned within the transmitter openings 178 and / or receiver openings 179 and serve as coating 180 to provide protection without adversely affecting the transmission of the transmitter 137 and the reception of the receiver 139. Essentially, coating 180 provides protection for the transmitter 137 and receiver 139 against moisture, dust, and other damage. It should be recognized that in some embodiments, the base 182 is not required, and the coating 180 may be independent, such as being directly retained within the transmitter opening 178 and / or receiver opening 179.

[0059] Figure 6 One embodiment includes an adhesive layer 190 located beneath the second sealing layer 170, below a base 182 containing the previously discussed coating 180. However, it should be understood that the adhesive layer 90 and the second sealing layer 170 can be a single component, for example, where the coating 180 is positioned directly within, for example, the transmitter opening 178 and the receiver opening 179. In this case, the adhesive 184 on the finger side 174 of the second sealing layer 170 will be a skin-compatible adhesive (in some embodiments, this adhesive will be less strong and / or permanent than the adhesive used to bond to another material layer, such as adhesive layer 190).

[0060] exist Figure 6 In the example shown, adhesive layer 190 extends between the tip side 191 and the knuckle side 193, and also between the left side 195 and the right side 197. The outer side 192 of adhesive layer 190 is configured to attach to base 182 and / or second sealing layer 170, for example, via adhesive 198, which may be the same as or different from the adhesive used to attach the other layers. Adhesive layer 90 also includes a finger side 194 opposite the outer side 192, configured to contact the skin of finger 9. Finger side 194 is provided with skin adhesive 196, which is biocompatible and configured to contact the skin of finger 9 in a manner known in the art. Figure 6 In the illustrated embodiment, the opening 199 is configured to pass through the adhesive layer 190 to provide unobstructed transmission of the transmitter 137 and the receiver 139.

[0061] exist Figure 6In one embodiment, the adhesive layer 190 is made of a dark color, which the inventors have determined improves ambient light attenuation (thereby including the opening 199 or at least a transparent area relative to the light generated by the emitter 137 to allow transmission by the optical component 138). However, other embodiments of this disclosure provide an adhesive layer 190 that is transparent or does not obstruct the emission of the emitter 137 or the reception of the receiver 139, or does so in a known and compensable manner, such that it is not necessary to pass through the opening 199 of the adhesive layer 190. For example, Figure 7 The sectional view shown illustrates a pattern similar to Figure 6 The sensing device 10 shown has a transparent adhesive layer 190, which eliminates the need for openings 199 to transmit and receive light. Other configurations that include more or fewer openings 199 or partially darkened portions of the adhesive layer 190 (e.g., around its perimeter) are also contemplated in this disclosure.

[0062] at last, Figure 6 A backing sheet 230 is depicted releasably adhered to the finger side 194 of the adhesive layer 190, and this backing sheet is removed before the sensing device 10 is attached to the finger 9. The backing sheet 230 extends between the tip side 231 and the knuckle side 233, and between the left side 235 and the right side 237. The backing sheet 230 is temporarily attached to the adhesive layer 90 on its inner side 234 and also has an outer side 232 opposite to the inner side 234. In this way, the backing sheet 230 can be peeled off from the adhesive layer 190 to expose the skin adhesive 196, thereby allowing the sensing device 10 to be positioned on the patient's finger 9.

[0063] Figure 7 It shows Figure 6 The cross-sectional side view of the illustrated embodiment now depicts the electrical system 140 within the cavity 121 formed within the carrier plate 100. In the illustrated embodiment, a light indicator 156, such as an LED, is also provided on the cover side 122 of the stacked portion 120 of the carrier plate 100. As previously discussed, the light indicator 156 can provide different colors, on / off states, or duty cycles to indicate different states of the sensing device 10.

[0064] Return to Figure 6In this embodiment, the inventors have configured the electronic device 90 and the carrier plate 100 in such a manner to provide additional benefits superior to devices currently known in the art. Firstly, by forming the carrier plate 100 in this manner, efficiency and cost savings can be achieved by using, for example, a single-sided PCT. Additionally, by separating the high-pitch (or high-frequency) electronic devices into different high-density boards (e.g., first circuit board 132 and second circuit board 136) electrically connected to the carrier plate 100, these devices can be built and tested individually before assembly with the overall electronic system 90. Similarly, the surrounding or folded configuration of the carrier plate 100 provides separation of high-frequency components (first circuit board 132 and second circuit board 136) to prevent or reduce interference or noise, while also shielding the analog electronic devices from environmental interference. For example, folding the carrier plate 100 around the power system 140 also limits the fold to an angle that does not excessively stretch the carrier plate 100, thereby preventing damage to the electrical contacts in the carrier plate. Non-limiting examples of “analog electronic devices” include the second circuit board 136, optical components 138, and the traces between them.

[0065] Similarly, in some embodiments, the antenna 131 for wireless communication may be copper etched on a PI (polyimide) or silver printed on a PET film positioned close to a first circuit board 132 on top of the stacked portion 120 of the carrier plate 100. This proximity of the RF electronics (within the first circuit board 132) avoids interference with the antenna 131 and also avoids an increased distance between the antenna 131 and the patient's skin. In other words, the sensing device 10 is optimized such that the RF device is away from the skin and the sensor device is close to the skin.

[0066] Figure 8 An exemplary control system 300 is depicted, which may be incorporated within a sensing device 10 for performing the functions discussed above, the sensing device being incorporated partially or entirely within a first circuit board 132 and / or a second circuit board 136. It should be understood that certain aspects of this disclosure are described or depicted as functional and / or logical block components or processing steps that may be performed by any number of hardware, software, and / or firmware components configured to perform specified functions. For example, some embodiments employ integrated circuit components (such as memory elements, digital signal processing elements, logic elements, lookup tables, etc.) configured to perform various functions under the control of one or more processors or other control devices. The connections between functional components and logical block components are merely exemplary and may be direct or indirect, and may follow alternative paths.

[0067] In some examples, the control system 300 communicates with each of the sensing device 10 and one or more other electronic components 130 of the central receiver 2 via a communication link CL, which can be any wired or wireless link. The control system 300 is able to receive information and / or control one or more operational characteristics of the sensing device 10 and its various subsystems by sending and receiving control signals via the communication link CL. In one example, the communication link CL is a Controller Area Network (CAN) bus; however, other types of links may be used. It should be understood that the degree of connectivity and the communication link CL can actually be one or more shared connections or links between some or all of the components in the sensing device 10. Furthermore, the communication link CL lines are intended only to illustrate that various control elements can communicate with each other and do not represent actual wiring connections between the various elements, nor do they represent the only communication path between the elements. Additionally, the sensing device 10 can incorporate various types of communication devices and systems, and therefore the communication link CL shown can actually represent various different types of wireless data communication systems and / or wired data communication systems.

[0068] The control system 300 may be a computing system including a processing system 310, a memory system 320, and an input / output (I / O) system 330 for communicating with other devices, such as input devices 299 (e.g., receivers 139 and / or wireless communication devices communicating with the first circuit board 132 and / or the second circuit board 134, and antenna 131) and output devices 301 (e.g., transmitter 137, wireless communication device, antenna 131). Any of these other devices may also be or alternatively stored in a cloud 302. The processing system 310 loads and executes an executable program 322 from the memory system 320, accesses data 324 stored in the memory system 320, and instructs the sensing device 10 to operate as described in further detail below.

[0069] The processing system 310 may be implemented as a single microprocessor or other circuitry, or distributed across multiple processing devices or subsystems that cooperate to execute the executable program 322 from the memory system 320. Non-limiting examples of the processing system include general-purpose central processing units, dedicated processors, and logic devices.

[0070] The memory system 320 may include any storage medium capable of being read by the processing system 310 and capable of storing executable program 322 and / or data 324. The memory system 320 may be implemented as a single storage device or distributed across multiple storage devices or subsystems that cooperate to store computer-readable instructions, data structures, program modules, or other data. The memory system 320 may include volatile and / or non-volatile systems and may include removable and / or non-removable media for storing information, implemented in any method or technology. For example, the storage medium may include non-transitory and / or transient storage media, including random access memory, read-only memory, magnetic disk, optical disk, flash memory, virtual memory and non-virtual memory, magnetic storage devices, or any other medium that can be used to store information and accessed by the instruction execution system.

[0071] In this way, the currently disclosed systems and methods provide SpO2 sensor devices configured to be securely attached to body parts, which remain lightweight, highly adjustable, recyclable, and offer additional benefits superior to those known in the prior art.

[0072] This written description uses examples to disclose the invention, including the best mode, and also enables those skilled in the art to perform and use the invention. Certain terms are used for the purposes of brevity, clarity, and ease of understanding. Unnecessary limitations should not be inferred from this description beyond the requirements of the prior art, as such terms are used for descriptive purposes only and are intended to be understood broadly. The patent scope of this invention is defined by the claims and may include other examples that would occur to those skilled in the art. These other examples are intended to be within the scope of the claims if they have features or structural elements that are not different from the literal language of the claims, or if they include equivalent features or structural elements that are not substantially different from the literal language of the claims.

Claims

1. A sensing device for acquiring data from a finger, the device comprising: A carrier plate having a stacked portion having a finger side configured to face the finger, a cover side opposite to the finger side, and a connector side located between the finger side and the cover side, wherein a tip wing extends from the stacked portion and is configured to wrap around the tip of the finger, and wherein the carrier plate has an outer side and an opposite inner side; Electronic components electrically coupled to the carrier plate, the electronic components including: A first circuit board is electrically coupled to the carrier plate on the cover side of the stacked portion; At least one optical component electrically coupled to the tip wing of the carrier plate, wherein the at least one optical component is configured to emit light toward the finger and detect the light from the finger, and wherein the carrier plate electrically couples the electronic component to acquire the data from the finger; A power system, located between the cover side and the finger side of the support plate, wherein the power system supplies power to the electronic components via the support plate; and A cover configured to secure the support plate to the finger.

2. The sensing device of claim 1, wherein the electronic component further comprises a second circuit board electrically coupled to the carrier plate on the cover side of the stacked portion.

3. The sensing device of claim 2, wherein the first circuit board is configured to provide communication with the device.

4. The sensing device of claim 3, wherein the communication is wireless.

5. The sensing device of claim 3, wherein the second circuit board controls the operation of the at least one optical component.

6. The sensing device of claim 2, wherein the second circuit board is coupled to the carrier plate on the finger side of the stacked portion.

7. The sensing device of claim 1, wherein the at least one optical component comprises two components, and wherein the two components are electrically coupled to the carrier plate such that they are located on opposite sides of the finger when the tip wing wraps around the tip of the finger.

8. The sensing device according to claim 1, wherein the power system is electrically coupled to the inside of the carrier plate.

9. The sensing device of claim 8, wherein the power system comprises one or more zinc-air batteries.

10. The sensing device of claim 9, wherein the cover comprises a cover, the cover side of the carrier plate extending into the cover, wherein the cover defines an opening therein, the opening being configured to allow gas exchange between the interior of the cover and ambient air, and wherein the opening is configured such that the surface tension of a liquid prevents the liquid from passing through the opening.

11. The sensing device of claim 1, wherein the power system includes a housing for holding two or more batteries.

12. The sensing device of claim 1, wherein the carrier plate is a single integrally formed material, wherein the cover side is folded relative to the connector side and the connector side is folded relative to the finger side.

13. The sensing device of claim 12, wherein the cover side is substantially parallel to the finger side.

14. The sensing device of claim 12, wherein, prior to folding, the connector side of the carrier plate extends 90 degrees away from the tip wing.

15. The sensing device of claim 1, wherein the electronic component further comprises one or more light indicators configured to indicate the state of the sensing device.

16. The sensing device of claim 15, wherein the one or more light indicators are one or more LEDs, and wherein the state of the sensing device is indicated based on at least one of the colors and illumination patterns of the one or more LEDs.

17. The sensing device of claim 1, wherein the electronic component further comprises an antenna for wireless communication with the sensing device.

18. The sensing device of claim 17, wherein the antenna is coupled to the cover side of the stacked portion of the carrier plate.

19. A method for enabling a sensing device to acquire data from a finger, the method comprising: The batteries are positioned inside the casing to form a power system together; Electronic components are electrically coupled to a carrier plate having a stacked portion and a tip wing extending therefrom, wherein the tip wing is configured to wrap around the tip of the finger, and wherein the carrier plate has an outer side and an opposing inner side, wherein the electronic components include a first circuit board coupled to the stacked portion and one or more optical components coupled to the tip wing, wherein the one or more optical components are configured to emit light toward the finger and receive the light from the finger, and wherein the carrier plate is electrically coupled to the electronic components to acquire the data from the finger; A cover is attached to the support plate, the cover being configured to secure the support plate to the finger; as well as The stacked portion of the carrier plate is wrapped around the power system to form a finger side configured to face the finger, a cover side opposite the finger side, and a connector side located between the finger side and the cover side. The power system provides power to the electronic component via the carrier plate, and the carrier plate is electrically coupled to the electronic component to acquire the data from the finger.

20. A SpO2 sensing device that can be fixed to a finger, the device comprising: A carrier plate made of a single integrally formed material, wherein the carrier plate has a stacked portion having a finger side configured to face the finger, a cover side opposite to the finger side, and a connector side located between the finger side and the cover side, wherein a tip wing extends from the stacked portion and is configured to wrap around the tip of the finger, and wherein the carrier plate has an outer side and an opposite inner side. Electronic components electrically coupled to the carrier plate, the electronic components including: A first circuit board is electrically coupled to the carrier plate on the cover side of the stacked portion, and the first circuit board provides wireless communication for the device; A light emitter coupled to the tip wing of the carrier plate and configured to emit light toward the finger; A light receiver, coupled to the tip wing of the carrier plate and configured to detect light from the finger, wherein the light emitter and the light receiver are positioned on the carrier plate so as to be on opposite sides of the finger in use; and A second circuit board, electrically coupled to the carrier plate on the finger side of the stacked portion, wherein the second circuit board controls the light emitter and the light receiver. The carrier plate is electrically coupled to the electronic components to determine SpO2 data from the finger based on the light detected by the light receiver; A power system, sandwiched between the cover side and the finger side of the stacked portion of the carrier plate, wherein the power system supplies power to the electronic components via the carrier plate; and A cover configured to secure the support plate to the finger.

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