SpO2 sensor having partitioned electronics

A sensing device for acquiring data from a finger. The device includes a carrier board having a stacked portion with a finger side and a canopy side. A tip wing extends from the stacked portion and wraps around the finger. Electrical components are coupled to the carrier board, including a first circuit board on the canopy side of the stacked portion, and one or more optical components electrically on the tip wing. The optical components are configured to transmit light towards the finger and to detect the light from the finger. The carrier board electrically couples the electrical components to acquire the data from the finger. A power system is positioned between the canopy side and the finger side of the carrier board, where the power system provides power to the electrical components via the carrier board. A cover secures the carrier board to the finger.

FIELD

The present disclosure generally relates to a SpO2 sensors having partitioned electronics, and more particularly to single-use SpO2 sensors partitioning high- and low-pitch electrical components.

BACKGROUND

Pulse oximetry is patient monitoring process known in the art for measuring the oxygen saturation within a blood stream, and particularly non-invasively. Specifically, pulse oximeters are devices configured to measure the peripheral oxygen saturation (SpO2) within a patient's bloodstream, which can provide invaluable information about the patient's health. Exemplary sensors known in the art can be classified as either reflective or transmissive sensor types. In each case, the pulse oximeter transmits light (typically of two wavelengths) through a body part, such as a finger or toe, whereby the light is then detected via a photodetector. Different materials absorb light at differing rates at the differing wavelengths. Therefore, it is possible to determine peripheral oxygen saturation using the detected light since oxygen in the bloodstream absorbs light differently than other materials, such as skin, bone, muscle, fat, and fingernail, for example. In the case of a transmissive configuration, the light transmission device and photodetector are positioned on opposing sides of a body part, for example where the light passes straight through a finger or toe. In contrast, reflectance pulse oximeters detect the light reflecting back from the body part, or in other words where the photodetector is not be on an opposing side of the body part from the transmitter.

It is critical for the accuracy for pulse oximeters that the device is provided in good contact with the body part. Likewise, it is important that ambient light is blocked so that the light detected at the photodetector is effectively exclusively from the transmitter.

SUMMARY

One embodiment of the present disclosure generally relates to a sensing device for acquiring data from a finger. The device includes a carrier board having a stacked portion with a finger side configured to face the finger, a canopy side opposite the finger side, and a connector side between the finger side and the canopy side, where a tip wing extends from the stacked portion and is configured to wrap around a tip of the finger, and where the carrier board has an exterior side and an opposite interior side. Electrical components are electrically coupled to the carrier board, the electrical components including a first circuit board electrically coupled to the carrier board on the canopy side of the stacked portion, and one or more optical components electrically coupled to the tip wing of the carrier board, where the one or more optical components are configured to transmit light towards the finger and to detect the light from the finger, and where the carrier board electrically couples the electrical components to acquire the data from the finger. A power system is positioned between the canopy side and the finger side of the carrier board, where the power system provides power to the electrical components via the carrier board. A cover is configured to secure the carrier board to the finger.

Another embodiment generally relates to a method for making a sensing device for acquiring data from a finger. The method includes positioning batteries within a housing to together form a power system, and electrically coupling electrical components to a carrier board. The carrier board has a stacked portion and a tip wing extending therefrom, where the tip wing is configured to wrap around a tip of the finger, and where the carrier board has an exterior side and an opposite interior side. The electrical 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 transmit light towards the finger and to receive the light from the finger. The carrier board electrically couples the electrical components to acquire the data from the finger. The method further includes coupling a cover to the carrier board, the cover being configured to secure the carrier board to the finger. The method further includes wrapping the stacked portion of the carrier board around the power system so as to form a finger side configured to face the finger, a canopy side opposite the finger side, and a connector side between the finger side and the canopy side. The power system provides power to the electrical components via the carrier board and the carrier board electrically couples the electrical components to acquire the data from the finger.

Another embodiment generally relates to an SpO2 sensing device securable on a finger. The device includes a carrier board having a single, integrally formed material, where the carrier board has a stacked portion with a finger side configured to face the finger, a canopy side opposite the finger side, and a connector side between the finger side and the canopy side. A tip wing extends from the stacked portion and is configured to wrap around a tip of the finger. The carrier board has an exterior side and an opposite interior side. Electrical components are electrically coupled to the carrier board, which include: a first circuit board electrically coupled to the carrier board on the canopy side of the stacked portion, the first circuit board providing wireless communication for the device; a light transmitter coupled to the tip wing of the carrier board and configured to transmit light towards the finger; a light receiver coupled to the tip wing of the carrier board and configured to detect the light from the finger, where the light transmitter and the light receiver are positioned on the carrier board so as to be on opposing sides of the finger in use; and a second circuit board electrically coupled to the carrier board on the finger side of the stacked portion, where the second circuit board control the light transmitter and the light receiver. The carrier board electrically couples the electrical components to determine SpO2 data from the finger based on the light detected by the light receiver. A power system is sandwiched between the canopy side and the finger side of the stacked portion of the carrier board, where the power system provides power to the electrical components via the carrier board. A cover is configured to secure the carrier board to the finger.

Various other features, objects and advantages of the disclosure will be made apparent from the following description taken together with the drawings.

DETAILED DISCLOSURE

Through experimentation and development, the inventors have recognized multiple problems with SpO2 sensor devices presently known in the art, both respect to usability, and the quality and accuracy of data being produced. In particular, the inventors have recognized the importance of SpO2 sensors being configured to be tightly fixed to a body part, such as a finger, which improves light transmission and helps reduce the detection of ambient light. The challenge of achieving good fixation is further exacerbated as SpO2 devices become wireless, allowing patients to become more mobile and active. The inventors have recognized that issues further arise with respect to the durability of single-use detectors being used over longer periods of time, in certain cases 72 hours or longer. In these extended duration situations, it is often necessary to periodically remove the sensor, for example when the patient washes their hands. However, the inventors have recognized that sensor devices presently known in the art do not do well being detached and reattached several times. The adhesives start to fail and/or the wrap material becomes damaged, leading to poor engagement with the skin that results in decreased comfort and degraded quality of the outputted data.

With respect to sensor devices presently known in the art, the inventors have recognized the following shortcomings. Certain sensors are of a “rubber boot” type configured to be reusable. However, the inventors have recognized that these devices are physically heavy due to the use of the thick elastomer, resulting in patient discomfort and poor resultant data. Fixation to the finger is also inadequate, as these rubber boot type sensors are not well suited for a full range of patient sizes (e.g., finger sizes), which can range greatly by weight, gender, and age, for example. In addition to poor fixation or pressure on the finger, the rubber boot style also provides poor breathability, once again degrading data output due to extensive sweating, and further worsening fixation.

Clip-type sensors also exist but are mechanically complex and thus are not suited for single-use devices (e.g., GE Healthcare's® TruSignal Finger Sensor TS-F-D.

Bandage type single-use sensors have also become common, which generally consist of a textile-like wrap with an adhesive surface for bonding to the skin (for example, GE Healthcare's® TruSignal Adult Adhesive Wrap sensor TS-AAW). These designs tend to lose adhesion when being detached and reattached. Additionally, the wraps of presently known devices are typically narrow and provide only minimal ambient light attenuation. GE Healthcare produces an airplane-type disposable sensor (for example, GE Healthcare's® TruSignal Adult/Pediatric sensors TS-AP having a wing that wraps over a fingertip, and two identical side wings that wrap around the finger that while covering the finger well and providing good ambient light attenuation is difficult to provide and maintain controlled pressure on the finger.

As will become apparent, the presently disclosed sensor devices solve many of the problems mentioned above, as well as providing other improvements for single-use sensors. Among these, the disclosed sensor is configured to be tightly (but adjustably) fixed to the finger, and to remain effective despite being attached and detached several times during an extended period of use, for example 72 hours or more. The disclosed sensors provide adequate pressure on the fingertip for optimal performance, and also provide good attenuation of ambient light.

The inventors have recognized that attenuation has become further problematic as patients increasingly use mobile devices while being monitored by an SpO2 sensing device. In this case, substantial light may be emitted from these mobile devices in close proximity to the SpO2 sensing devices, effecting the accuracy of the outputted data since not all detected light is coming from the patient. Moreover, the disclosed sensors are lightweight, provide for a minimal amount of materials for disposing, refurbishing, and/or recycling (e.g., of batteries), and allow for breathability such that extensive sweating does not occur.

It will be recognized that while the present disclosure principally refers to SpO2 devices, the devices and methods disclosed herein are also applicable for other devices being coupled to a subject (which is not limited to humans, for example also including animals), and not limited to placement on a finger (for example, including wrists, arms, ankles, legs, toes, or an entire foot for a neonatal infant). For example, the disclosed methods and devices may be adapted for single-use blood pressure monitoring, blood glucose monitoring, drug delivery infusion devices, and other medical or non-medical devices. Likewise, while the present disclosure generally refers to communication with the device being wireless, wired configurations are also anticipated.

FIG.1depicts an exemplary embodiment of a sensing device10according to the present disclosure. As shown, the overall system1includes the sensing device10for obtaining SpO2 data from a finger9of a patient. The sensing device10communicates via a wireless communication device and antenna131with a central receiver2in a manner known in the art. For example, wireless communication may be provided via Bluetooth®, wi-fi, or other long, short, or medium range wireless protocols known in the art. In the example shown, the central receiver2has a display4and controls6and communicates with the sensing device10via wireless connections8therebetween.

The sensing device10extends from a tip side11aligned with the tip of the finger9, to a knuckle side13, as well as a left side15and right side17. A top12is oriented above the finger9, with an opposite bottom14on the underside of the finger. The sensing device10is held in place on the finger9by a wrap20(also referred to as a cover), which is discussed further below. A canopy70extends above the wrap20and contains at least a portion of the electrical components for the sensing device10therein, which are discussed further below. The canopy70provides the space for these electrical components to extend above the wrap20, while also protecting them from moisture, impact, and/or other damage or interference.

FIGS.2and3depict the wrap20and canopy70of the sensing device10ofFIG.1from top and bottom views, respectively, without electrical components installed therein. The wrap20has an exterior side22opposite a finger side24, whereby the finger side24is configured to contact the finger9of the patient in use. The wrap20is formed by a central portion30having a length31and a width33and defining a central opening36therein. A tip wing40having a bulb47and an extension49extends from the central portion30of the wrap20. The tip wing40is configured to wrap over the tip of the finger9such that a portion of the extension49remains above the finger (e.g., on the fingernail) with the bulb47opposing the portion of the extension49on the underside of the finger9. The tip wing40has a base end42and distal end44extending a length of41therebetween, and also widths43A,43B corresponding to the extension49and bulb47. It will be recognized that while the bulb47has a greater width43B than the width43A of the extension49, this is not required, and other configurations are anticipated by the present disclosure. The wrap20may be formed of materials presently known in the art, including woven or non-woven fabrics, films, tapes, or foams, for example.

As also shown inFIGS.2and3, first and second side wings50,60also extend from the central portion30in opposing directions from each other. In the embodiment shown, the first side wing50has a base end52and distal end54and extends a length51therebetween. The first side wing50has widths53A,53B and is shown to be extending from the central portion30approximately 90° apart from the extension of the tip wing40. Similarly, the second side wing60has a base end62and distal end64and extends a length61therebetween. The second side wing60has widths63A,63B, which like the widths53A,53B of the first side wing50taper downwardly as the second side wing60and first side wing50extend away from the central portion30. The inventors have recognized that wrapping the wrap20around the finger9on three sides as presently shown is particularly effective at attenuating ambient light, as well as fixating the device.

It will be recognized that while the present disclosure principally focuses on wraps having three wings that wrap around a finger, other numbers of wings are also anticipated, whether for use with fingers or other parts of a subject. For example, other embodiments according to the present disclosure include two side wraps without a tip wing, a single side wrap that attaches to itself (with or without a tip wing), and other configurations (e.g., multiple side wings resembling a butterfly bandage, with or without a tip wing), to name a few.

In the embodiment ofFIGS.2and3, an adhesive196is provided on the finger side24of the wrap20, particularly on the second side wing60, to assist in fixating the sensing device10on the finger9. This embodiment also features additional adhesive196provided over the central portion30, as discussed further below. In addition to these adhesives196,FIGS.2and3depict an attachment system including the first attachment portion210and second attachment portion220configured to releasably engage each other, which in the present example are hook and loop type fasteners (e.g., Velcro®). The first attachment portion210is affixed to the finger side24of the wrap20particularly on the first side wing50, and in the present example is the “loop” portion of the attachment system as this side faces the finger9of the patient. Likewise, the second attachment portion220is affixed to the exterior side22of the wrap20, particularly on the second side wing60, and in the present case constitutes the “hook” that engages the loops. It will be recognized that different types of fasteners (e.g., “touch” or 3M®'s “dual lock” fasteners) may be used as the first attachment portion210and second attachment portion220, as well as alternating the positions of these first and second attachment portions210,220.

In the examples shown inFIGS.2and3, the first attachment portion210has a tip side211, knuckle side213, left side215, and right side217. An exterior side212is configured to engage with the second attachment portion220, and an interior side (not labeled) is configured to be attached to the wrap20, for example using an adhesive. Exemplary adhesives available in the market include double coated polyethylene tape, acrylic adhesive tape, and others known in the art. In a similar manner, the second attachment portion220extends between a tip side221and a knuckle side223, and between a left side225and a right side227. An exterior side222is configured to engage with the first attachment portion210in the manner previously described, and an interior side (not labeled) is configured to be attached to the wrap20in a secured manner.

By providing the attachment system of the first attachment portion210and second attachment portion220in addition to the use of adhesives, the inventors have recognized that the sensing device10can be reattached many times with no degradation on the ability to fixate the sensing device10on the finger9. In some examples, the adhesive196provided between the sensing device10and the finger9is configured to generally provide friction that resists translation and rotation of the sensing device10relative to the finger9, whereas pressure on the finger9is adjustably provided through engagement of the first attachment portion210and second attachment portion220.

Since the attachment system provided by the first attachment portion210and second attachment portion220need not adhere to the skin, durable and highly-reusable materials such as hook and loop fasteners may be incorporated, providing hundreds or even thousands of reuses to accommodate for pressure adjustments and the like. The first and second attachment portions210,220also allow the patient to frequently remove the sensing device10for washing hands and the like. Particularly in light of the COVID-19 pandemic, the inventors have recognized that the ability to enable frequent hand washing without discouraging the removable of the sensing device10, or requiring frequent replacement thereof, is highly beneficial over systems presently known in the art. In short, the inventors have identified that the “sticky” type securement from adhesives, along with a non-adhesive secondary attachment system (the first and second attachment portions210,220) provide a combined benefit that is greater than the sum of these parts separately.

Remaining withFIGS.2and3, the sensing device10includes a canopy70having an exterior side20facing away from the finger9, and an interior side74towards the finger9. The canopy70extends a length71and a width73such that an interior volume80is provided therein for retaining a portion of the electronics for operating the sensing device10discussed further below. In the example shown, an edge82of the canopy70is permanently or semi-permanently coupled to the wrap20in a water-tight manner via a weld region83, which may be welded using laser welding or other types of welding known in the art. Other methods for attaching the canopy70to the wrap20include adhesives, or integral formation between the two, for example. The canopy70may be formed of a plastic or ceramic material, for example, to provide waterproofing and impact protection for the components retained therein. In certain embodiments, the canopy70is constructed of ABS plastic, polycarbonate, polyamide PA6, and/or polyamide PA66, for example.

In certain embodiments, the weld region83where canopy70meets the wrap20forms a transmissive border by which light generated within the canopy70is visible to the patient or caregiver from the outside. For example, the weld region83(which need not be welded, but is referred to for simplicity) may be made of polycarbonate, a clear acrylic, and/or fiberoptic material with light indicators156(FIG.7, discussed below) positioned in sufficient proximity that a portion or the entire transmissive boarder glows.

In certain embodiments, the canopy70is removable (e.g., via a razor blade cutting the weld region83) so as to provide service and/or replacement to the electronic components held therein, for example to replace batteries before returning the device to (new) service. In this manner, a new canopy70may then be re-adhered or re-welded to the wrap20, which allows a single-use sensing device10to be refurbishable for many uses. In certain examples, other steps are also involved in the refurbishment process, including sterilization and the application of a new adhesive196for contacting the skin of a new patient, and applying a new temporary backing sheet, for example.

The embodiment shown inFIG.2depicts light openings86provided within the canopy70, which provide visibility to LEDs or other lights indicators (see156ofFIG.7) within the interior volume80of the canopy70to be seen outside of the sensing device10. In particular, these light openings86may be used for communicating a status of a pairing process between the sensing device10and a central receiver2, a power state, a communication state, or battery level for the sensing device10, and/or provide indications as to the current SpO2 level being detected by the sensing device10. For example, different colors may represent different states (green for high battery, yellow for medium, red for low), flashing and/or pulsing at different rates during the pairing process or other operations, or a combination of these features, for example.

In the embodiment shown inFIG.6, the canopy70further defines vent openings84therein, which in the present example allow for gas exchange between the interior volume80of the canopy70and the ambient air. In the case of using Zn-air batteries, which are discussed further below, these vent openings84also provide for necessary oxygen for the chemical reactions of these batteries, while still being defined sufficiently small so as to prevent moisture from entering the canopy70to damage electrical components therein. In particular, the inventors have recognized that vent openings84may be particularly sized such that heat and air flow may occur, but that the surface tension of water and other liquids prevents such moisture from passing through the vent openings84.

FIG.4depicts an exemplary carrier board100within the electronics system90(FIG.6) for operating the sensing device10. The carrier board100is shown in a flat configuration, before being formed and installed within the sensing device10. In particular, the carrier board100has a central portion110configured to substantially align with the central portion30of the wrap20. A tip extension112extends from the central portion110and is configured to substantially align with the tip wing40of the wrap20. A side extension114comprising a connector116and shelf118extend from the central portion110as well, whereby the side extension114is configured to be folded or rolled into a stacked portion120(FIG.6) to be discussed below. A notch111is formed in the central portion110, serving as a strain relief for the side extension114.

In the embodiment shown inFIG.4, the tip extension112and the side extension114extend away from the central portion110at approximately 90° apart. In total, the carrier board100extended between the tip side101and a knuckle side103, and between a left side105and a right side107. As will be more apparent in view of the folded form shown inFIG.6, the carrier board100has an exterior side102opposite an interior side104. Fold lines106depict where the carrier board100of the present embodiment is folded or rolled as shown inFIG.6. As will become apparent, the carrier board100is configured such that a power system140(FIG.5) can be retained within the interior side104of the carrier board100, specifically within the stacked portion120.

FIG.5depicts an exemplary power system140such as may be incorporated within the electronics system90to power the sensing device10. The power system140ofFIG.5includes a housing142defining receivers143configured to receive one or more batteries144. Springs146are provided such that the batteries144make contact with upper contacts148and lower contacts152, which are anchored to the housing142via anchors150,154, respectively, in a manner presently known in the art. In certain embodiments, the housing142is made of a rigid material, such as plastic, to provide sufficient strength for supporting the springs146, upper contacts148, and lower contacts152.

As discussed above and shown inFIG.6, the power system140is configured to be received within a cavity121defined within the stacked portion120, formed by virtue of folding the side extension114in the manner previously discussed. This provides for space savings due to the greater density of the electronic system90, and also isolation between components within the electronics system as discussed below. The power system140is electrically coupled to the carrier board100in a manner known in the art.

FIG.6depicts the sensing device10as layers, which provide features and functionality described above, but also provides for efficient manufacturing and water-sealing for electrical components therein. The uppermost layer shown is the wrap20(including the canopy70) previously discussed, which may include an adhesive on the underside of the central portion30for coupling to the next layer, in the present case is first sealing layer160. It will be recognized that while the present example shows a first sealing layer160and a second sealing layer170, greater or fewer sealing layers may be used, and thus different configurations are anticipated by the present disclosure. In certain embodiments, the sealing layers are made of a foam material. Exemplary materials for constructing the sealing layers include Vancive 2120U+3M1774 W by Avery Dennison® and/or NMC TA-100+3M 1522 medical tape by 3M®.

In the example shown inFIG.6, the first sealing layer160is configured to substantially overlap with the central portion30of the wrap20. The first sealing layer160extends between tip side161and knuckle side163and left side165and right side167. An exterior side162is configured to be coupled to the wrap, such as via an adhesive168on the first sealing layer160, wrap, or both. A finger side164is opposite of the exterior side162, which may also in certain embodiments be provided with an adhesive168for adhering to the carrier board100, which may be the same or different from the adhesive on the exterior side162and/or on the wrap20. The first sealing layer160defines an opening166therethrough, which in the present example includes a notch169. This opening166is configured to receive at least a portion of the stacked portion120of the carrier board100therein. A notch169provided within the opening166of the first sealing layer160for generally aligning with the stacked portion120of the carrier board100, thus enabling centering and alignment of the carrier board100and the first sealing layer160.

Remaining withFIG.6, the stacked portion120of the carrier board100is defined as having a canopy side122, finger side124, and connector side126therebetween. At least a portion of the stacked portion120is received within the canopy70by extending through the opening166in the first sealing layer160. As previously discussed, the power system140(not presently shown) may be incorporated within the cavity121of the stacked portion120. Additionally, a first circuit board132is electrically coupled to the carrier board100and positioned on the shelf118thereof. In this manner, the first circuit board132is also configured to be retained within the canopy70when assembled.

In certain examples, the carrier board100is single or double sided etched copper on polyimide (PI) film, approximately 0.2 mm thick, for example. In other examples, the carrier board100is formed of polyethylene (PET) or thermoplastic polyurethane (TPU). On which the traces may be printed, for example using silver ink.

In certain embodiments, the first circuit board132is configured to provide wireless connectivity between the sensing device10and central receiver2. The first circuit board132includes a microcontroller unit (MCU), radio circuit (RFID), power management unit (PMU), and antenna. The electronics circuits may be separate or parts of a single silicon (e.g., nRF52), or packaged in a single hybrid component, for example. In certain examples, the first circuit board132is approximately 10 mm×10 mm and approximately 0.5 mm thick. The first circuit board132may be constructed of FR4 with etched copper tracings as known in the art, which may be 4 or 6 layers thick, for example. In certain examples the component pitch is tight, down to 0.4 mm. Large pads of approximately 1 mm thickness may be used on the non-component side for bonding the first circuit board132to the carrier board100. Bonding between the first circuit board132and the carrier board100may be done by soldering (e.g., for PI) and/or conductive adhesives such as silver-epoxy or anisotropic conductive file (ACF) (e.g., for PET or TPU).

It will be recognized that these dimensions have been provided as merely exemplary and are not limitations on the present disclosure.

A second circuit board136is also electrically coupled to the carrier board100. However, in contrast to the first circuit board132provided on the canopy side122of the stacked portion120, the second circuit board136is coupled on the finger side124of the stacked portion120. In certain embodiments, the second circuit board136is configured to control the optical components138and to process data received therefrom, which is further sent to the first circuit board136. In certain embodiments, the second circuit board136includes analog front-end (AFE) and optical components. One such example of an AFE is an Analog Devices ADPD106 or AD80396 as known in the art, which includes LED drivers, amplifiers, and AD-converters. The AFE may communicate with the microcontroller unit (MCU) on the first circuit board132via serial data bus, such as SPI or I2C, for example.

It will be recognized that the specific configuration of components between the first circuit board132and second circuit board136is not fixed and may be configured in many ways. By way of providing another non-limiting example, the PMU, AFE, and MCU are located on the second circuit board136, with the RFID and antenna being on the first circuit board132. In certain examples, the RFIC is a hybrid including the MCU, RF, and antenna.

In further examples, a redundant MCU may be avoided by including the AFE on the second circuit board136and a single-chip MCU/RF on the first circuit board132. The antenna may reside on the first circuit board132, or may be implemented as part of other structures (for example, on the carrier board100or printed on the canopy70). In this configuration, the PMU may reside on either of the first circuit board132or second circuit board136(the latter potentially providing improved measurement noise performance).

Also coupled on the exterior side102of the carrier board100, though in the present example not within the stacked portion120, are optical components138for transmitting and/or receiving light to detect SpO2 levels of the patient. In the example shown, the optical components138include a transmitter137, and a separate receiver139, which as previously discussed are configured to be positioned on opposing sides of the finger9in use such that light is transmitted therethrough. The optical components138may be chosen from among those presently known in the art, or others that transmit light, receive light, or both transmit and receive light, for example.

An exemplary transmitter137available in the market is the Osram SFH 7016. Likewise, an exemplary receiver139is the Osram BPW 34 S-Z or SFH 2200. However, it will be recognized that these optical components138are merely exemplary and that other optical components138are also anticipated by the present disclosure.

In certain embodiments, the carrier board100and one or more electrical components130coupled thereto are overmolded so as to protect the assembly, which may then serve as a replaceable subcomponent for refurbishment and the like.

As shown in the embodiment ofFIG.6, a second sealing layer170is provided below the carrier board100, and in certain examples coupled thereto via an adhesive184, which may be provided on the sealing layer170and/or on the carrier board100. The second sealing layer170extends between a tip side171and a knuckle side173, and between a left side175and a right side177. The second sealing layer170is coupled to the carrier board170, and in certain places directly to the finger side164of the first sealing layer160, on its exterior side172. A finger side174is opposite of the exterior side172and an opening176is defined through the second sealing layer170. The opening176is configured to substantially receive the second circuit board136therein. In particular, the second circuit board136is defined as having a height H1, and in the embodiment shown the height H2of the second sealing layer170is configured to be at least as great as the height H1of the second circuit board136. The inventors have chosen to provide a second sealing layer170having a height H2at least as great as the height H1of the second circuit board136such that the patient cannot feel any electronics extending from the finger side124of the second circuit board136when the sensing device10is positioned on the finger9.

Sensor openings are also defined within the second sealing layer170, in the present example a transmitter opening178in alignment with the transmitter137and a receiver opening179in alignment with the receiver139. In the present example shown inFIG.6, the heights of the transmitter137and receiver139are less than the height H1of the second circuit board136, and thus the height H1of the second sealing layer170provides that the patient cannot feel the transmitter137and/or receiver139when the sensing device10is positioned on the finger9. This allows the light transmitted from the transmitter137and received by the receiver139to pass through the second sealing layer170unimpeded. This configuration also provides for sealing out ambient light by the transmitter opening178and receiver opening179being defined within the material of the second sealing layer170.

In the embodiment shown inFIG.6, a protective layer is also provided to protect the integrity of the transmitter137and receiver139, particularly as there is a direct transmitter opening178and receiver opening179through the second sealing layer170. In the example shown, a coating180is provided on a base182, which may be adhered to the finger side174of the second sealing layer170using an adhesive such as described above. In other examples, coatings180may be provided directly within the transmitter opening178and/or receiver opening179, or in other words overlapping these openings. For example, drops of silicone may be positioned within the transmitter opening178and/or receiver opening179and serve as the coating180to provide protection without adversely impacting the transmitting of the transmitter137, and the receiving by the receiver139. In essence, the coating180provides protection for the transmitter137and receiver139from moisture, dust, and other damage. It will be recognized that in certain embodiments, a base182is not necessary, and the coatings180may be independent, such as being retained within the transmitter opening178and/or receiver opening179directly.

The embodiment ofFIG.6includes an adhesive layer190below the second sealing layer170, below the base182containing the coating180previously discussed. However, it will be recognized that the adhesive layer90and the second sealing layer170may be a single component, for example where the coatings180are positioned directly within the transmitter opening178and receiver opening179, for example. In this case, the adhesive184on the finger side174of the second sealing layer170would be a skin-compatible adhesive (which in certain embodiments would not be as strong and/or permanent as an adhesive for bonding to another material layer, such as the adhesive layer190).

In the example shown inFIG.6, the adhesive layer190extends between a tip side191and a knuckle side193, and also between a left side195and right side197. An exterior side192of the adhesive layer190is configured to be coupled to the base182and/or second sealing layer170, for example via an adhesive198, which may be the same or different from adhesives used for coupling other layers. The adhesive layer90further includes a finger side194opposite the exterior side192, which is configured to contact the skin of the finger9. The finger side194is provided with a skin adhesive196, which is biocompatible and configured to contact the skin of the finger9in a manner presently known in the art. In the embodiment shown inFIG.6, openings199are provided through the adhesive layer190to provide unimpeded transmission of the transmitter137and receiver139.

In the embodiment ofFIG.6, the adhesive layer190is made of a dark color, which the inventors have identified to improve ambient light attenuation (thereby including openings199or transparent regions—at least with respect to the light produced by the transmitter137—to allow transmission by the optical components138). However, other embodiments according to the present disclosure provide for an adhesive layer190that is transparent or otherwise either does not impede transmission by the transmitter137or receiving by the receiver139, or does so in a known and compensatable manner such that no openings199are needed through the adhesive layer190. For example, the section view shown inFIG.7shows a sensing device10similar to that shown inFIG.6, but having a transparent adhesive layer190such that no openings199are required for transmission and receipt of the light. Other configurations, including greater or fewer openings199or partially darkened portions of the adhesive layer190(e.g., surrounding the perimeter thereof) are also anticipated by the present disclosure.

Finally,FIG.6depicts a backing sheet230is releasably adhered to the finger side194of the adhesive layer190, which is removed before attaching the sensing device10to the finger9. The backing sheet230extends between a tip side231and a knuckle side233, and between a left side235and a right side237. The backing sheet230is temporarily coupled to the adhesive layer90on an interior side234, also having an exterior side232opposite the interior side234. In this manner, the backing sheet230may be peeled away from the adhesive layer190to expose the skin adhesive196, allowing the sensing device10to be positioned on the patient's finger9.

FIG.7shows a sectional side view of the embodiment shown inFIG.6, now depicting the power system140in position within the cavity121formed within the carrier board100. In the embodiment shown, light indicators156, such as LEDs, are also provided on the canopy side122of the stacked portion120of the carrier board100. As previously discussed, the light indicators156may provide differing colors, on/off states, or duty cycles to indicate different states for the sensing device10.

Returning to the embodiment ofFIG.6, the inventors have configured the electronics90and carrier board100in this manner to provide additional benefits over devices presently known in the art. First, by forming the carrier board100in this manner, it is possible to attain efficiency and cost-savings by using a single-sided PCT, for example. Additionally, by separating the high-pitch (or high frequency) electronics into distinct, high-density boards that are electrically connected to the carrier board100(e.g., the first circuit board132and second circuit board136), these devices may be separately built and tested before being assembled with the overall electronics system90. Likewise, the wrap-around or folded construction of the carrier board100provides for separation of the high-frequency components (first circuit board132and second circuit board136) to prevent or reduce interference or noise, while also shielding the analog electronics from ambient interference. Folding the carrier board100around the power system140also limits the folds to angles that will not overly strain the carrier board100, preventing damage to electrical contacts therein, for example. Non-limiting examples of “analog electronics” include the second circuit board136, optical components138, and traces therebetween.

Likewise, in certain embodiments, the antenna131for wireless communication may be etched copper on PI, or printed silver on PET film positioned in close proximity to the first circuit board132atop the stacked portion120of the carrier board100. This proximity of the RF electronics (within the first circuit board132) avoids interference with the antenna131, and likewise from the increased distance of the antenna131from the patient's skin. In other words, the sensing device10is optimized such that RF devices are far from the skin, and sensor devices are near the skin.

FIG.8depicts an exemplary control system300that may be incorporated within the sensing device10for performing the functions discussed above, which may be incorporated in part or whole within the first circuit board132and/or the second circuit board136. It will be recognized that certain aspects of the present disclosure are described or depicted as functional and/or logical block components or processing steps, which may be performed by any number of hardware, software, and/or firmware components configured to perform the specified functions. For example, certain embodiments employ integrated circuit components, such as memory elements, digital signal processing elements, logic elements, look-up tables, or the like, configured to carry out a variety of functions under the control of one or more processors or other control devices. The connections between functional and logical block components are merely exemplary, which may be direct or indirect, and may follow alternate pathways.

In certain examples, the control system300communicates with each of the one or more other electrical components130of the sensing device10and the central receiver2via a communication link CL, which can be any wired or wireless link. The control system300is capable of receiving information and/or controlling one or more operational characteristics of the sensing device10and its various sub-systems by sending and receiving control signals via the communication links CL. In one example, the communication link CL is a controller area network (CAN) bus; however, other types of links could be used. It will be recognized that the extent of connections and the communication links CL may in fact be one or more shared connections, or links, among some or all of the components in the sensing device10. Moreover, the communication link CL lines are meant only to demonstrate that the various control elements are capable of communicating with one another, and do not represent actual wiring connections between the various elements, nor do they represent the only paths of communication between the elements. Additionally, the sensing device10may incorporate various types of communication devices and systems, and thus the illustrated communication links CL may in fact represent various different types of wireless and/or wired data communication systems.

The control system300may be a computing system that includes a processing system310, memory system320, and input/output (I/O) system330for communicating with other devices, such as input devices299(e.g., the receiver139and/or wireless communication devices and the antenna131communicating with the first circuit board132and/or second circuit board134) and output devices301(e.g., the transmitter137, wireless communication devices, the antenna131), either of which may also or alternatively be stored in a cloud302. The processing system310loads and executes an executable program322from the memory system320, accesses data324stored within the memory system320, and directs the sensing device10to operate as described in further detail below.

The processing system310may be implemented as a single microprocessor or other circuitry, or be distributed across multiple processing devices or sub-systems that cooperate to execute the executable program322from the memory system320. Non-limiting examples of the processing system include general purpose central processing units, application specific processors, and logic devices.

The memory system320may comprise any storage media readable by the processing system310and capable of storing the executable program322and/or data324. The memory system320may be implemented as a single storage device, or be distributed across multiple storage devices or sub-systems that cooperate to store computer readable instructions, data structures, program modules, or other data. The memory system320may include volatile and/or non-volatile systems, and may include removable and/or non-removable media implemented in any method or technology for storage of information. The storage media may include non-transitory and/or transitory storage media, including random access memory, read only memory, magnetic discs, optical discs, flash memory, virtual memory, and non-virtual memory, magnetic storage devices, or any other medium which can be used to store information and be accessed by an instruction execution system, for example.

In this manner, the presently disclosed systems and methods provide for SpO2 sensor devices configured to be tightly fixed to a body part, which remaining lightweight, highly adjustable, recyclable, and providing other benefits over those known in the prior art.