Patent Application
20140275883
The present disclosure relates generally to medical devices and, more particularly, to medical sensors such as those used for pulse oximetry.
This section is intended to introduce the reader to various aspects of art that may be related to various aspects of the present disclosure, which are described and/or claimed below. This discussion is believed to be helpful in providing the reader with background information to facilitate a better understanding of the various aspects of the present disclosure. Accordingly, it should be understood that these statements are to be read in this light, and not as admissions of prior art.
In the field of medicine, doctors often desire to monitor certain physiological characteristics of their patients. Accordingly, a wide variety of devices have been developed for monitoring many such physiological characteristics. These devices provide doctors and other healthcare personnel with the information they need to provide the best possible healthcare for their patients. As a result, such monitoring devices have become an indispensable part of modern medicine.
One technique for monitoring certain physiological characteristics of a patient is commonly referred to as pulse oximetry, and the devices built based upon pulse oximetry techniques are commonly referred to as pulse oximeters. Pulse oximetry may be used to measure various blood flow characteristics, such as the blood-oxygen saturation of hemoglobin in arterial blood, the volume of individual blood pulsations supplying the tissue, and/or the rate of blood pulsations corresponding to each heartbeat of a patient. In fact, the “pulse” in pulse oximetry refers to the time-varying amount of arterial blood in the tissue during each cardiac cycle.
Pulse oximeters and other types of monitoring devices typically use either disposable sensors, which are discarded after a single use, or reusable sensors. Disposable sensors may provide convenience in the medical setting and may lower the risk of transferring bacteria or disease between patients. However, certain sensor components, especially electrical components, within the sensor may be expensive. Reusable sensors may lower the overall cost of the sensor per use, but these sensors generally require more effort and time on the part of the medical practitioner. For example, such reusable sensors must be thoroughly disinfected after each use.
Additionally, typical pulse oximetry sensors may communicate with a patient monitor using a communication cable. For example, a sensor may use such a communication cable to send a signal corresponding to a measurement performed by the sensor to the patient monitor for processing. However, the use of communication cables may limit the applications available, as the cables may become prohibitively expensive at long distances as well as limit a patient's range of motion by physically tethering the patient to a monitoring device. Although wireless sensors may transmit information without the need for a communication cable, the sensors typically rely on wireless transceivers for communication and batteries to power the sensor. Such wireless transceivers and batteries are often relatively expensive components of a sensor, and thus are generally impractical for use in disposable sensors. Additionally, certain features, such as the wireless transceiver and batteries, may be bulky. For example, in such wireless sensors, a large portion of the bulk and weight of the sensor may be attributable to the battery used to power the sensor, and thus, it may be difficult to adequately and comfortably secure the sensor to the patient.
Advantages of the disclosed techniques may become apparent upon reading the following detailed description and upon reference to the drawings in which:
One or more specific embodiments of the present techniques will be described below. In an effort to provide a concise description of these embodiments, not all features of an actual implementation are described in the specification. It should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which may vary from one implementation to another. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure.
In certain circumstances, it may be desirable to have a medical sensor having both a disposable portion and a reusable portion that function together for patient monitoring. As discussed above, disposable sensors may provide convenience in the medical setting and may lower the risk of transferring bacteria or disease between patients, while reusable sensors may generally lower the overall cost per sensor. Thus, a sensor having both the disposable portion and the reusable portion may combine the convenience and other benefits of disposable sensors with a reduced cost per sensor provided by the reusable portion.
Additionally, it may be desirable to provide a wireless sensor having both the disposable portion and the reusable portion, as wireless sensors may allow for increased mobility of the patient as compared with traditional wired sensors. However, as noted above, such wireless sensors require a wireless transceiver to communicate with a monitor and a power source (e.g., a battery) to power the various components within the sensor. The wireless transceiver and/or battery may be relatively expensive components, and thus may not be well-suited for use in disposable sensors. Therefore, the present embodiments are generally directed to a medical sensor having both a disposable portion and a reusable portion that function together for patient monitoring, and the reusable portion may generally include certain components that are easily reused or relatively expensive sensor components (e.g., the wireless transceiver) to reduce the cost per sensor.
Furthermore, as described above, certain components of wireless sensors (e.g., the wireless transceiver and/or the battery) may be relatively large and bulky. Accordingly, it may be desirable to place these components in more comfortable locations on the patient and/or to use various wraps and bands to securely and comfortably couple the sensor, to the patient.
Monitoring systems and wireless sensors in accordance with the present disclosure may provide certain advantages over typical wired disposable or reusable sensors. For example, such wireless sensors do not require cables to communicate with a monitor, which may reduce interference from such cables and also allow for increased mobility of a patient. Additionally, having both a disposable portion and a reusable portion may provide significant cost savings over traditional disposable sensors. For example, having both the disposable portion and the reusable portion enables certain components to be discarded, while other components may be reused. Generally, less expensive components (such as an emitter) or smaller components may be disposed in the disposable portion, which allows easy application of such components to the patient. However, certain relatively expensive components (such as wireless transceivers, batteries, and/or detectors) or components that may be readily reused may be disposed in the reusable portion, thus reducing the cost per sensor. In some cases, separation of components into the disposable portion and the reusable portion may also enable the system to include larger components, such as a larger, long-lasting battery and/or a more powerful wireless transceiver. Additionally, separation of components into the disposable portion and the reusable portion may enable large components (e.g., a large battery) to be positioned away from the measurement site in a suitable or more comfortable location (e.g., the back of a hand of the patient) during a monitoring session.
As discussed in detail below, the disposable portion and the reusable portion may be coupled together in any suitable way, and the various components of the sensor (e.g., emitter, detector, wireless transceiver, battery, calibration element, etc.) may be arranged in any suitable manner within the disposable portion and the reusable portion. For example, in some embodiments, as described in more detail below, the disposable portion may include the emitter, the detector, and the calibration element, while the reusable portion may include the battery and the wireless transceiver. In certain embodiments, the disposable portion may include the emitter and the calibration element, while the reusable portion may include the detector, the battery, and the wireless transceiver, for example. In other embodiments, the disposable portion may include the emitter, detector, calibration element, and battery, while the reusable portion may include the wireless transceiver, for example.
Additionally, the disposable portion and the reusable portion of the wireless sensors described herein may be configured to be positioned on a variety of tissue locations on a patient, such as on a finger, a toe, a foot, an ankle, an ear, a wrist, a forehead, or any other appropriate measurement site. As discussed in more detail below, such sensors may be utilized for adults and neonates alike, and the various portions of the sensors may be applied to the patient through various means, including adhesives, garments, wraps, and so forth. For example, in some embodiments, the sensor may be fitted into or placed against a wearable garment, such as a glove or headband.
Although the embodiments described below generally relate to wireless photoplethysmography, disclosed embodiments may be adapted or configured to obtain a variety of medical measurements with a suitable medical sensor. For example, the system and devices described herein may, additionally or alternatively, be configured to measure patient temperature, transvascular fluid exchange volumes, tissue hydration, blood flow, blood microcirculation, respiration, ECG, non-invasive blood pressures (NIBP), blood pulse transit time, and/or others.
With the foregoing in mind,
The patient monitor 20 may include a display 22, a wireless module 24 for transmitting and receiving wireless data, a memory, a processor, and various monitoring and control features. Based on data received from the wireless sensor 12, the patient monitor 20 may display patient measurements and perform various measurement or processing algorithms. For example, when the system 10 is configured for pulse oximetry, the patient monitor 20 may perform blood oxygen saturation calculations, pulse measurements, and other measurements based on the data received from the wireless sensor 12. Furthermore, to provide additional functions, the patient monitor 20 may be coupled to a multi-parameter patient monitor 26, for example, via a cable 28 connected to a sensor input port or via a cable 30 connected to a digital communication port. The multi-parameter module 26 may process and/or display physiological parameters from other sensors in addition to the data from the monitor 20 and sensor 12.
Like the patient monitor 20, the sensor 12 may include a wireless module 32. The wireless module 32 of the wireless sensor 12 may establish a wireless communication 34 with the wireless module 24 of the patient monitor 20 using any suitable protocol. By way of example, the wireless modules 24, 32 may be capable of communicating using the IEEE 802.15.4 standard, and may communicate, for example, using ZigBee, WirelessHART, or MiWi protocols. Additionally or alternatively, the wireless modules 24, 32 may be capable of communicating using the Bluetooth standard or one or more of the IEEE 802.11 standards. In an embodiment, the wireless module 32 may include a transmitter (such as an antenna) for transmitting wireless data, and the wireless module 24 includes a receiver (such as an antenna) for receiving wireless data. In an embodiment, the wireless module 32 also includes a receiver for receiving instructions (such as instructions to switch modes), and the wireless module 24 also includes a transmitter for sending instructions to the sensor 12.
The emitter 42 and detector 44 may be generally configured for patient monitoring and may be arranged in a reflectance or transmission-type configuration with respect to one another. For example, in some embodiments in which the sensor 12 is configured for use on a patient's finger, the emitter 42 and detector 44 may be in a reflectance or a transmission configuration. In embodiments in which the sensor 12 is configured for use on a patient's forehead, the emitter 42 and detector 44 may be in a reflectance configuration. Regardless of the particular arrangement of the emitter 42 and detector 44, the emitter 42 may be a light emitting diode, a superluminescent light emitting diode, a laser diode or a vertical cavity surface emitting laser (VCSEL). Generally, the light passed through the tissue is selected to be of one or more wavelengths that are absorbed by the blood in an amount representative of the amount of the blood constituent present in the blood. The amount of light passed through the tissue varies in accordance with the changing amount of blood constituent and the related light absorption. In certain embodiments, the sensor 12 may be configured to perform traditional pulse oximetry measurements, regional pulse oximetry measurements, or the like. In embodiments where the sensor 12 is configured to perform regional pulse oximetry measurements, the emitter 42 may include two or more LEDs, each LED being configured to emit a different wavelength of light.
The emitter 42 may be configured to emit at least two wavelengths of light, e.g., red and infrared (IR) light, into the tissue of the patient. The red wavelength may be between about 600 nanometers (nm) and about 700 nm, and the IR wavelength may be between about 800 nm and about 1000 nm. However, any appropriate wavelength (e.g., green, yellow, etc.) and/or any number of wavelengths (e.g., three or more) may be used. Regardless of the number of emitters 42 or the number of LEDs within each emitter 42, light from the emitter 42 may be used to measure, for example, oxygen saturation, water fractions, hematocrit, or other physiologic parameters of the patient. It should be understood that, as used herein, the term “light” may refer to one or more of ultrasound, radio, microwave, millimeter wave, infrared, visible, ultraviolet, gamma ray or X-ray electromagnetic radiation, and may also include any wavelength within the radio, microwave, infrared, visible, ultraviolet, or X-ray spectra, and that any suitable wavelength of light may be appropriate for use with the present disclosure.
The detector 44 may be an array of detector elements that may be capable of detecting light at various intensities and wavelengths. In one embodiment, light enters the detector 44 after passing through the tissue of the patient. In another embodiment, light emitted from the emitter 42 may be reflected by elements in the patent's tissue to enter the detector 44. The detector 44 may convert the received light at a given intensity, which may be directly related to the absorbance and/or reflectance of light in the tissue of the patient, into an electrical signal. That is, when more light at a certain wavelength is absorbed, less light of that wavelength is typically received from the tissue by the detector 44, and when more light at a certain wavelength is transmitted, more light of that wavelength is typically received from the tissue by the detector 44. After converting the received light to an electrical signal, the detector 44 may send the signal to the monitor 20, where physiological characteristics may be calculated based at least in part on the absorption and/or reflection of light by the tissue of the patient. In embodiments where the sensor 12 is configured for regional saturation monitoring, two detectors 44 may be provided, with one detector 44 relatively close (e.g., proximal) to the emitter 42 and one detector 44 relatively far (e.g., distal) from the emitter 42.
As noted above, in certain embodiments, the disposable portion 14 of the sensor 12 may also include a calibration element 46 that may provide signals indicative of the wavelength of one or more light sources of the emitter 42, which may allow for selection of appropriate calibration coefficients for calculating a physical parameter such as blood oxygen saturation. The calibration element 46 may, for instance, be a coded resistor, EPROM or other coding devices (such as a capacitor, inductor, PROM, RFID, parallel resident currents, barcode, or a colorimetric indicator) that may provide a signal to the monitor 20. The signals may be related to the characteristics of the sensor 12 to enable the microprocessor to determine the appropriate calibration characteristics of the sensor 12, for example.
As described above, the sensor 12 may have both the disposable portion 14 and the reusable portion 16, and the disposable portion 14 may be coupled to the reusable portion 16 through any suitable means. In certain embodiments, as shown in
The reusable portion 16 may include any of a variety of components to facilitate patient monitoring, and the components may be arranged within the reusable portion 16 in any suitable manner. In the depicted embodiment, the reusable portion 16 includes the sensor body 58 which may support certain electrical components and/or power sources for the sensor 12. For example, the sensor body 58 of the reusable portion 16 may support the wireless module 32 for wirelessly communicating with the monitor 12. Additionally, the reusable portion 16 may support a battery 60 configured to supply power to various components (e.g., the emitter 42) of the sensor 12. The reusable portion 16 may also include circuitry 62 (e.g., a low power circuit board) to control the operation of various components (e.g., the emitter 42, the detector 44, etc.) of the sensor 12. In some embodiments, the reusable portion 16 may include a battery meter that may provide a visible indication of battery life, as described in more detail below. Thus, in the sensor 12 illustrated in
The sensor body 58 of the reusable portion 16 may be formed from any suitable material, including rigid or conformable materials, such as foam or other padding materials (e.g., a sponge or gel), fiber, fabric, paper, rubber or elastomeric compositions (including acrylic elastomers, polyimide, silicones, silicone rubber, celluloid, PMDS elastomer, polyurethane, polypropylene, polyethylene, acrylics, nitrile, PVC films, acetates, and latex). In some embodiments, the body 58 of the reusable portion 16 may be a water-proof housing and may encapsulate the battery 60 and the various electrical components disposed therein. Such a configuration may protect such components, and may also allow the reusable portion 16 to be easily cleaned and thoroughly disinfected after each use. For example, the body 58 may enable the reusable portion 16 to be submerged in a disinfecting solution without damaging the components within the body 58.
The reusable portion 16 may generally take any form that enables the reusable portion 16 to be coupled to the disposable portion 14 and to be comfortably positioned on the patient. In particular, the reusable portion 16 may be configured to be positioned on a variety of tissue locations on a patient, such as on a finger, a toe, a foot, an ankle, a wrist, or a forehead. In some embodiments, the reusable portion 16 may be configured to clip to or to wrap around the tissue of the patient, for example. In certain embodiments, the reusable portion 16 may have an adhesive surface to adhere to the patient or to another surface, such as a mounting surface of a band or a wrap, as described in more detail below. In particular, as shown in
In some embodiments, a disposable cover may be provided to cover (e.g., surround, fit around, etc.) at least part of the reusable portion 16. Thus, the disposable cover may fit or wrap around the body 58 of the reusable portion 16. For example, the disposable cover may include hook and loop material to secure the disposable cover to or around the reusable portion 16. The cover may be wrapped around the reusable portion 16 before the reusable portion 16 is coupled to the disposable portion 14 for patient monitoring. In some embodiments, the disposable cover may be attached to and may extend from the disposable portion 14, thus forming a platform, pocket, or cavity for receiving and covering the reusable portion 16 when the reusable portion 16 is coupled to the disposable portion 14. The portion of the disposable cover that extends from the disposable portion 14 may have an adhesive surface for receiving and holding the reusable portion 16 and/or may include a flap that can be wrapped around the reusable portion 16. Regardless of the form, the disposable cover may generally be configured to separate the reusable portion 16 from the tissue of the patient and/or the ambient environment in order to protect the reusable portion 16 and/or to limit the spread of bacteria or disease as the reusable portion 16 is reused or transferred from patient to patient. At the conclusion of the patient monitoring session, the disposable cover may be easily removed and discarded, and the reusable portion 16 may be retained for reuse.
Additionally, each of the portions 14, 16 of the sensor 12 may be configured to be placed on or proximate to (e.g., near, adjacent, etc.) the patient's skin for patient monitoring. In some embodiments, the portions 14, 16 of the sensor 12 may be configured to attach to or be coupled to the patient. For example, the sensor body 40, 58 may include an adhesive or other gripping surface configured to secure the sensor 12 to the patient's skin or to another suitable surface, such as a mounting surface of a band or a wrap, as described below. As noted above, in some circumstances, the disposable portion 14 may remain on the patient for long periods of time. Therefore, it may be desirable to be able to easily replace the reusable portion 16, to provide power (e.g., via battery 60) to the disposable portion 14 over a long period of time, for example. In such cases, the reusable portion 16 may be detached from the disposable portion 14 (or from the flex circuit 18). A new (e.g., charged) reusable portion 16 may then be coupled to the disposable portion 14, without having to remove the disposable portion 14 from the patient. In other cases, the disposable portion 14 may become dislodged or may require replacement, or a different type of disposable portion 14 (e.g., a disposable portion 14 having a different type or configuration of emitters 42) may be desired. In such cases, the disposable portion 14 may be disconnected from the reusable portion 16. Subsequently, the new disposable portion 14 can be easily coupled to the reusable portion 16, without having to remove the reusable portion 16 from the patient.
Additionally, in the embodiment depicted in
In some circumstances, the reusable portion 16 may be too bulky or large for placement over (or adjacent to) certain measurement sites, such as a fingertip of the patient, for example. In other words, it may uncomfortable or impractical to position the reusable portion 16 adjacent to the disposable portion 14 or on certain body locations. Additionally, in some systems, it may be desirable for the reusable portion 16 to include a relatively large battery 60 for long-lasting power and/or relatively large circuitry 62 for higher processing capabilities. In such cases, the reusable portion 16 may be configured to be disposed away from the measurement site and/or at a different body location from the disposable portion 14. For example, the reusable portion 16 may be configured to be disposed on a hand of the patient when the disposable portion 14 is disposed on the finger of the patient.
In some embodiments, a garment 70 (e.g., a band, glove, sock, etc.) may be provided to protect and/or to secure the disposable portion 14 and/or the reusable portion 16 to the tissue of the patient. The garment 70 may provide additional benefits, such as regulating (e.g., warming) the temperature of the tissue of the patient and lowering the incidence of vasoconstriction. The garment 70 may be particularly useful for patients having low perfusion. For example, as shown in
The glove 70 may alternatively provide a mounting surface or element (not shown) or a pocket 72 configured to receive and to hold the reusable portion 16 of the sensor 12, for example. In some embodiments, the mounting element provides an adhesive surface or a mechanical attachment (e.g., a snap, a clip, etc.) for mounting the reusable portion 16 on an exterior surface of the glove 70. In some embodiments, as shown in
In certain embodiments, the glove 70 may be disposable and the disposable portion 14 and/or the flex circuit 18 (or a cable or a wire) may be integrated into or attached to the glove 70. More specifically, in certain embodiments, the disposable portion 14 and/or the flex circuit 18 may be sewn or woven into the glove 70. Thus, in operation, the disposable portion 14 and/or the flex circuit 18 may be applied to the patient when the glove 70 is placed on the hand of the patient. The reusable portion 16 may then be electrically coupled to the disposable portion 14 via the flex circuit 18, for example, and patient monitoring may commence. At the conclusion of a monitoring session, the disposable portion 14 and/or the flex circuit 18 may be disconnected from the reusable portion 16. The disposable glove 70, along with the integrated disposable portion 14 and/or the integrated flex circuit 18, may be discarded.
In alternate embodiments, the reusable portion 16 may be attached to or integrated into the glove 70. In such cases, the glove 70 may not be disposable, but may be cleaned and disinfected for use with different patients and/or may be reused in multiple different monitoring sessions for the same patient. Thus, the glove 70 and the reusable portion 16 may form a reusable unit and may be connected to a disposable portion 14 (e.g., via the flex circuit 18) for monitoring the patient. At the conclusion of the monitoring session, the glove 70 and the reusable portion 16 may be reused for the same patient at a later time, transferred from one patient to another, or may be reused with various disposable portions 16, for example.
Additionally, the glove 70 may be a fingerless glove (e.g., the glove 70 does not cover the fingertips of the patient) as shown in
As noted above, placing the reusable portion 16 away from the measurement site, such as on the back of the hand of the patient, may be more comfortable for the patient in certain cases and may accommodate large components, such as a large battery and/or large processing components. However, in some circumstances, it may be desirable to position the disposable portion 14 and the reusable portion 16 in close physical proximity. For example, placing the disposable portion 14 and the reusable portion 16 in proximity to each other may reduce noise within the system 10. Additionally, in some embodiments, it may be desirable to position the disposable portion 14 and the reusable portion 16 closely enough so that the detector 44 may be incorporated into the reusable portion 16 of the sensor 12. The detector 44 is often a relatively expensive component of the sensor 12, and thus, incorporating the detector 44 into the reusable portion 16 of the sensor 12 may provide significant cost savings. Additionally, disposing the detector 44 within the reusable portion 16 may enable the disposable portion 14 to be smaller, thus resulting in additional cost savings. Moreover, relatively less shielding, or in some cases no shielding, may be required when the detector 44 is disposed within the reusable portion 16 (or in a different portion than the emitter 44), leading to additional cost savings, as well as a less complex design. More particularly, various shielding components are typically employed in sensors 12 to isolate the detector 44 from noise interference. In the present embodiments, shielding may be provided proximate to the detector 44 and/or to the circuitry 62. However, where the emitter 42 is in the disposable portion 14 and the detector 44 is within the reusable portion 16, and the portions 14, 16 are coupled via a wire or a cable, shielding may not be required at or proximate to the detector 44. Furthermore, in embodiments where the portions 14, 16 are joined by a flexible connection, such as a flex circuit, the sensor 12 may be configured to emit light and detect light without any shielding means. In other words, the sensor 12 may be configured to enable the detector 44 to accurately detect the reflected or transmitted light for patient monitoring (i.e., with no interference, or with an acceptable amount or level of interference).
Accordingly,
As mentioned above, the portions 14, 16 of the sensor 12 may be configured to be disposed on a variety of tissue locations on the patient, such as on a finger, a toe, a foot, an ankle, a wrist, or a forehead. The particular embodiments of the sensor 12 of
The disposable portion 14 and the reusable portion 16 of the sensor 12 depicted in
In particular,
However, in some embodiments, as shown in
In certain embodiments, as shown in
In some embodiments, the disposable portion 14 may be attached to or integrated into the headband 90. More specifically, the disposable portion 14 may be sewn or woven into the headband 90, and the disposable portion 14 may be applied to the tissue of the patient when the headband 90 is placed on the patient. The disposable portion 14 may be integrated into the headband 90 such that the disposable portion 14 directly contacts the patient's skin when the headband 90 is placed on the patient. However, in other embodiments, the disposable portion 14 may be integrated into the headband 90 adjacent to (e.g., over) the transparent window 98 of the headband 90, such that the emitted light may pass from the emitter 42 and through the transparent window 98 into the patient's tissue. In embodiments where the disposable portion 14 is integrated into the headband 90, the headband 90 may also include a mounting surface 96 for receiving and/or mounting the reusable portion 16. Thus, the reusable portion 16 may be mounted on the mounting surface 96 and coupled to the integrated disposable portion 14 via the flex circuit 18 or via contacts 82, for example. In some embodiments, the headband 90 may include the pocket 102 for receiving and holding the reusable portion 16. Thus, the reusable portion 16 may be placed within the pocket 102 and coupled to the integrated disposable portion 14 for patient monitoring. At the conclusion of a monitoring session, the reusable portion 16 may be disconnected from the disposable portion 14 and removed from the pocket 102, and the headband 90 and the integrated disposable portion 14 may be discarded as a unit.
In other embodiments, the reusable portion 16 may be integrated into the headband 90. In such cases, the headband 90 may not be disposable, but may be cleaned and disinfected for use with different patients and/or reused in multiple different monitoring sessions for the same patient. Thus, at the conclusion of a monitoring session, the disposable portion 14 may be removed and discarded, while the headband 90 and the reusable portion 16 may be removed as a unit and/or reused with various disposable portions 14.
In certain circumstances, such as in monitoring neonates, it may be desirable to position the sensor 12 on the patient's wrist or ankle. While the sensor 12 may be similar for adult and neonatal applications, in some embodiments, the sensor 12 may have a different configuration for neonates. One such possible configuration is shown in
In neonatal application, it may be desirable to place the sensor 12 on or near the patient's wrist or ankle for patient monitoring. Thus, in some embodiments, a band 120 or a wrap 130 configured to protect the sensor 12 and to couple the sensor 12 to the wrist or ankle of the patient is provided. The band 120 or the wrap 130 configured to wrap around the patient's wrist or ankle may also beneficially secure the sensor 12 to the patient without the need for adhesives, which may injure or irritate the fragile skin of neonates.
In certain embodiments, the band 120 may generally be configured to slide over and to circumferentially surround the ankle or the wrist of the neonate patient. In contrast, the wrap 130 may include extensions 132 that partially or completely wrap around the wrist or ankle of the patient. In certain embodiments, the wrap 130 may include a first extension 132a and a second extension 132b that are configured to wrap around the wrist or the ankle and to attach to each other. The extensions 132a, 132b may attach to each other via any suitable mechanism, such as via a hook and loop fabric, for example. Although embodiments of the band 120 and the wrap 130 have some structural differences (e.g., extensions 132), embodiments of the band 120 and the wrap 130 may also share certain features to secure the sensor 12 to the wrist or ankle of the patient, and thus are described together below.
As with the headband 90, the band 120 and the wrap 130 may take any of a variety of configurations to couple the sensor 12 to the patient. For example, the band 120 and the wrap 130 may be configured to be wrapped over or positioned over the sensor 12. Thus, the disposable portion 14 and the reusable portion 16 of the sensor 12 may be coupled together and applied to the patient's skin. The band 120 or the wrap 130 may then be wrapped over or placed over the sensor 12, protecting the sensor 12 and applying a normal force against the sensor 12 to secure the sensor 12 to the wrist or ankle of the patient for monitoring. In such cases, the band 120 or the wrap 130 may be transparent or may include a transparent portion to enable visualization of the battery meter 80.
In other embodiments, as shown in
In some embodiments, a single mounting surface 138 having a size and shape that generally corresponds to the sensor 12 may be provided to mount the sensor 12 onto the band 120 or the wrap 130. However, in other embodiments, as shown in
The transparent window 140 may be generally configured to facilitate transmission of the light emitted by the emitter 42 through the band 120 or the wrap 130 and into the patient's tissue. The transparent window 140 may also be configured to enable detection of the reflected (or transmitted) light by the detector 44. Thus, in some embodiments, the portions 14, 16 of the sensor 12 may be mounted on the mounting surface 138 and such that the emitter 42 and the detector 44 are each positioned over (e.g., adjacent) the transparent portion of the mounting surface 138 and over the transparent window 140. In some embodiments, both the mounting surface 138 and the transparent window 140 may generally have a size, shape, and configuration that correspond to the sensor 12. However, in other embodiments, one or more transparent windows 140 may be provided to correspond with and align with the emitter 42 and detector 44 when the portions 14, 16 are coupled to the band 120 or the wrap 130. For example, as shown in
Additionally, alignment indicia may be provided, such as visible lines or marks on the band 120 or the wrap 130 to enable the operator to visually confirm proper placement of the portions 14, 16 with respect to the mounting surface 138 and/or the transparent windows 140. Furthermore, in some embodiments, the mounting surface 138 and/or the transparent window 140 may be recessed so that the sensor 12 may generally fit within the recess of the band 120 or the wrap 130, as best shown in
In some embodiments, it may be desirable to provide a protective layer or securing layer to cover the sensor 12 when the sensor 12 is coupled to the band 120 or the wrap 130. Such securing layers may be particularly useful in neonatal applications, where sensors 12 are likely to be dislodged by patient movement, for example. Thus, in some embodiments, the band 120 or the wrap 130 may include one or more securing layers configured to be placed over the portions 14, 16 of the sensor 12 when mounted to the band 120 or the wrap 130. The securing layer combined with other portions of the band 120 or the wrap 130 (e.g., the top layer 136 and/or the mounting surface 138 and/or the transparent window 140) may generally form a pocket to receive and to hold the disposable portion 14 and/or the reusable portion 16. The pocket formed on the band 120 or the wrap 130 may be similar to the pocket 102 described above with respect to
In some embodiments, the disposable portion 14 may be attached to or integrated into the band 120 or the wrap 130. More specifically, the disposable portion 14 may be sewn or woven into the band 120 or the wrap 130, and the disposable portion 14 may be applied to the tissue of the patient when the band 120 or the wrap 130 is placed on the patient. In such cases, the disposable portion 14 may be positioned so that the disposable portion 14 directly contacts the patient's skin when the band 120 or the wrap 130 is placed on the patient. However, in other embodiments, the disposable portion 14 may be integrated into the band 120 or the wrap 130 adjacent to (e.g., over) a transparent window 140, such that the emitted light may pass from the emitter 42 and through the transparent window 140 into the patient's tissue. In embodiments where the disposable portion 14 is integrated into the band 120 or the wrap 130, the band 120 or the wrap 130 may include a mounting surface 138 for receiving and/or mounting the reusable portion 16. Thus, the reusable portion 16 may be mounted on the mounting surface 138 and coupled to the integrated disposable portion 14 via the flex circuit 18 or via contacts 82, for example. In some embodiments, the band 120 or the wrap 130 may include the securing layer that forms the pocket for receiving and holding the reusable portion 16. Thus, the reusable portion 16 may be placed within the pocket and coupled to the integrated disposable portion 14 for patient monitoring. At the conclusion of a monitoring session, the reusable portion 16 may be disconnected from the disposable portion 14 and removed from the pocket, while the integrated disposable portion 14 and the band 120 or the wrap 130 may be discarded as a unit.
In other embodiments, the reusable portion 16 may be integrated into the band 120 or the wrap 130. In such cases, the band 120 or the wrap 130 may not be disposable, but may be cleaned and disinfected for use with different patients and/or reused in multiple different monitoring sessions for the same patient. Thus, at the conclusion of a monitoring session, the disposable portion 14 may be removed and discarded, while the band 120 or the wrap 130 and the integrated reusable portion 16 may be either remain on the patient for use with a second disposable portion 14 or may be removed as a unit and reused for various patients.
While the disclosure may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail herein. However, it should be understood that the embodiments provided herein are not intended to be limited to the particular forms disclosed. Rather, the various embodiments may cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure as defined by the following appended claims. Further, individual features of the disclosed embodiments may be combined or exchanged.
