System and method for monitoring patient and fetus during labor and delivery

Abstract

An integrated labor management system is used to monitor laboring patients and their fetus or fetuses during labor and delivery. The system is intended to reduce complications, improve quality labor care and, ultimately, reduce adverse maternal and neonatal outcomes. The system is designed for labor monitoring by caregivers such as obstetricians, nurses, and midwives. By integrating the technologies described, the integrated care delivery system provides a low-cost, fit-for-purpose, highly interoperable and customizable labor management technology package for LMIC settings.

Description

PATENT SIBEL-011 PCTSYSTEM AND METHOD FOR MONITORING PATIENT AND FETUSDURING LABOR AND DELIVERY

[0001] This application claims priority to and the benefit of U.S. Prov. Pat. App. Ser. No. 63 / 722,452, which was filed on November 19, 2024, and is hereby incorporated herein by reference in its entirety for all purposes, including the right of priority.

[0002] Not applicable.

[0003] The present disclosure relates generally to a system and method for monitoring patient and fetus during labor and delivery.

[0004] This section of this document introduces information about and / or from the art that may provide context for or be related to the subject matter described herein and / or claimed below. It provides background information to facilitate a better understanding of the various aspects of the present invention. This is a discussion of “related” art. That such art is related in no way implies that it is also “prior” art. The related art may or may not be prior art. The discussion in this section of this document is to be read in this light, and not as admissions of prior art.

[0005] Labor and delivery in a clinical environment typically include monitoring the physical health of both the mother and the fetus. Much of this monitoring is performed using various medical monitors and associated sensors. Some monitoring systems furthermore include, for example, central stations and remote workspaces at which one or more patients’ physical condition may be monitored or analyzed.

[0006] The presently disclosed labor and delivery communicatively integrated care delivery system provides an integrated system rather than disparate sensor and display systems or a combination of paper systems and digital. The disclosed system collects maternal vital signs, fetal heart rate tracing, point of care ultrasound, auto-populating a digital partograph, as well as other functionalities as further disclosed below. The ascribed functionality ensures that information is entered in a timely manner and risk is evaluated automatically based on all available information. By providing better monitoring and information for care providers, the system helps mitigate or minimize unnecessary medical interventions unless they are needed for safety, promoting a more natural labor process when possible.PATENT SIBEL-011 PCT

[0007] In a first aspect, a method of monitoring a patient during labor and delivery and a fetus that is being birthed by the patient comprises: receiving physiological parameters of the patient from a physiological sensor; receiving physiological parameters of the fetus from a physiological sensor; receiving user input containing parameters about the patient or fetus; and calculating a risk level based on the patient and fetus physiological parameters and / or user input parameters.

[0008] In a second aspect, a communicatively integrated care delivery system for use in monitoring a patient during labor and delivery and a fetus that is being birthed by the patient comprises a sensor suite and a monitor. The sensor suite further comprises: a physiological sensor configured to monitor one or more physiological parameters of the patient; and a physiological sensor configured to monitor one or more physiological parameters of the fetus. The sensor suite is designed to communicate physiological parameters acquired from the patient and the fetus to the monitor.

[0009] In a third aspect, an integrated labor management system configured to perform a method comprising receiving physiological parameters of the patient from a physiological sensor; receiving physiological parameters of the fetus from a physiological sensor; receiving user input containing parameters about the patient or fetus; and calculating a risk level based on the patient and fetus physiological parameters and / or user input parameters.

[0010] In a fourth aspect, a method of monitoring a patient during labor and delivery and a fetus that is being birthed by the patient is substantially as shown and described.

[0011] In a fifth aspect, an integrated labor management system is substantially as shown and described.

[0012] The above presents a simplified summary in order to provide a basic understanding of some aspects of what is claimed below. This summary is not an exhaustive overview of the claimed subject matter. It is not intended to identify key or critical elements of the disclosure or to delineate the scope of the claims. Its sole purpose is to present some concepts in a simplified form as a prelude to the more detailed description that is discussed below.BRIEF DESCRIPTION OF THE DRAWINGSPATENT SIBEL-011 PCT

[0013] The detailed description is made with reference to the accompanying drawings and is provided to assist in a comprehensive understanding of various example embodiments of the present disclosure. Changes may be made in the function and arrangement of elements discussed without departing from the spirit and scope of the disclosure. Various embodiments may omit, substitute, or add various procedures or components as appropriate. For instance, features described with respect to certain embodiments may be combined in other embodiments. In addition, descriptions of well-known functions and constructions may be omitted for clarity and conciseness. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the examples described herein can be made without departing from the spirit and scope of the present disclosure.

[0014] In the drawings, like reference numbers generally indicate identical, functionally similar, and / or structurally similar elements.

[0015] FIG. 1 conceptually illustrates a labor and delivery communicatively integrated care delivery system in accordance with one or more embodiments.

[0016] FIG. 2 depicts an example patient monitor interface.

[0017] FIG. 3 depicts a plurality of displays in an example of a central monitoring station.

[0018] FIG. 4 depicts an example electronic fetal monitor as applied to a patient.

[0019] FIG. 5 depicts an example screen or view displaying acquired, sensed data.

[0020] FIG. 6 depicts an example partograph display.

[0021] While the disclosed subject matter is susceptible to various modifications and alternative forms, the drawings illustrate specific implementations described in detail by way of example. It should be understood, however, that the description herein of specific examples is not intended to limit that which is claimed to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the appended claims.DETAILED DESCRIPTION

[0022] The presently disclosed labor and delivery communicatively integrated care delivery system is an integrated labor management system used to monitor laboring patients and their fetus or fetuses during labor and delivery. The system is intended to reduce complications, improve quality labor care and, ultimately, reduce adversePATENT SIBEL-011 PCT maternal and neonatal outcomes. The system is designed for labor monitoring by caregivers such as obstetricians, nurses, and midwives. By integrating the technologies described below, the system is a low-cost, fit-for-purpose, highly interoperable and customizable labor management technology package for low and middle income settings.

[0023] Turning now to the drawings, the labor and delivery communicatively integrated care delivery system 100 of FIG. 1 includes a digital, auto-populated partograph linked with sensors 105 delivering, by way of example and without limitation, maternal vital signs and sensors delivering fetal sensors (such as fetal heart rate and uterine contractions). Some of these sensors 105 may be wearable, some may not.

[0024] Patients 110 are monitored with sensors 105, including wearable sensors, connected to bedside (“local”) monitors 112 and central (“remote”) monitors 113 throughout their labor and delivery course. As used herein, “local” means within arm’s reach, or at least within the presence of, the patient 110. For example, within arm’s reach of the patient’s bedside 115 or within line of sight from the patient’s bedside 115 would be considered “local”. “Remote” means not local. For example, a central monitoring station 114 at which the central monitors 113 of a central monitoring station 114 are located is usually located down the hall from the patient’s room or even on a different floor of a facility and, so, are considered “remote” as that term is used herein. Similarly, anything outside of the facility in which the patient’s bedside 115 is located would also be considered “remote”.

[0025] Additionally, the bedside monitor 112, also sometimes referred to as a patient monitor, may integrate with a point of care ultrasound and / or other, similar, patient care technologies. These additional sensors and tracking capabilities may facilitate patient intake and point of care risk stratification. More accurate and timely risk-stratification and plan development may reduce risk during labor and delivery and will assist with institutional referral or intra-institutional treatment pathways.

[0026] The system 100 is an integrated system collecting maternal vital signs, uterine activity, fetal heart rate, and point of care ultrasound to auto-populate a digital partograph as mentioned above. The system 100 is designed for automatic population of data from the sensors 105 that are paired with manual entry from care providers (not shown) as desired, for example the results of a cervical dilation assessed by a sterile vaginal examPATENT SIBEL-011 PCT performed by a healthcare professional. Automatic population reduces clinician workload and simplifies labor monitoring and risk tracking.

[0027] The system 100, powered by care stratification algorithms, can be used to identify and / or predict risk in labor and guide management, including clinician decision making on normal labor progression, escalation of care, or expedition of delivery by cesarean section, independent of care setting. Additionally, the system 100 can be used to triage incoming patients. The ability to triage pregnant patients to the appropriate setting and pathway is essential to reduce maternal morbidity and mortality. Thus, the labor and delivery communicatively integrated care delivery system 100 will serve as a digital front door for this decision-making process driven by vital signs, point of care ultrasound, key demographics, and obstetrical history to create a risk-based triage system no matter the location of care presentation.

[0028] The labor and delivery communicatively integrated care delivery system 100 extends a platform that already allows for essential demographic inputs. The system 100 provides an easy-to-use checklist format to collect obstetrical history (e.g., gestational age, prior obstetrical history, patient’s medical history, current medications, etc.) that can populate a digital partograph or document in the medical record.

[0029] In addition to the maternal vital signs monitoring offered by ANNE One, the presently disclosed system 100 adds fetal monitoring and tracing. The system 100 includes a plurality of patient sensors 105. Such sensors 105 may include, by way of example and without limitation, a chest sensor, a pulse oximeter, and compatible applications that include but are not limited to a bedside monitor 112 and a central monitoring station 114. Additionally, the system 100 can interface to regulatory-approved, commercially available, third-party devices (not shown) that provide additional monitoring capability, such as blood pressure monitors, thermometers, and fetal sensors, resulting in a highly customizable system.

[0030] All sensed parameters are US Food and Drug Administration (“FDA”)-cleared in patients 12 years and older for use in both the home and hospital setting. Examples of such parameters include, but are not limited to, electrocardiogram (“ECG”) for heart rate, respiratory rate, peripheral oxygen saturation (“SpO2”), body position, step count, fall count, temperature, blood pressure via a wireless wearable blood pressure cuff. OnePATENT SIBEL-011 PCT particular embodiment includes wireless wearable sensors with intensive care unit (“ICU”)-grade data and a mobile device interface with alarms and alerts that can be silenced or turned off if desired.

[0031] The patient monitor 112 in the illustrated embodiment is a bedside monitor. The patient monitor 112 is, in this particular embodiment, a wireless tablet that can easily be transported with the patient 110 to various patient care settings within the facility. This system 100 employs several elements of the ANNE® One Platform commercially available from Sibel Health, Inc. The patient monitor runs the ANNE® View application. Data is captured by the ANNE® sensor suite, including the ANNE® Chest, ANNE® Limb, as well as fetal monitor sensors worn by the mother. Sensed data is transmitted to the patient monitor 112 where it is displayed and incorporated into digital partograph and risk scoring and stratification. That is, the patient monitor 112 is programmed to receive sensed data from the sensors 105 and implement them in a digital partograph, in risk scoring, and in stratification.

[0032] The intuitive patient monitor interface 200, one embodiment of which is shown in FIG. 2, allows for rapid toggling between views of the intuitive patient monitor interface 200 selected and / or dictated by the clinician’s preferences and clinical needs. The patient monitoring screen, which is the particular screen from the patient monitor interface 200 shown, is the default view for the patient monitor 112. Alternative views / screens include partograph and early warning score views.

[0033] Returning to FIG. 1 , The sensors 105 may be wired or wireless. When wireless, as in the illustrated embodiment, the sensors 105 can be paired to the patient monitor 112 through wireless links. Suitable communications technologies for the wireless links include BLUETOOTH®, near field communication (“NFC”) tap, or ultra-wideband (“UWB”) perimeter detection. Those in the art having the benefit of this disclosure may appreciate still other wireless communications technologies that may be suitable and / or desirable for other embodiments.

[0034] As mentioned above, the sensors 105 in the illustrated embodiment include the ANNE® Chest sensor and the ANNE® Limb sensor. The ANNE® Chest sensor provides an ECG waveform, the ECG-derived heart rate, as well as respiratory rate and patient temperature. Arrhythmia monitoring can be provided with a continuous processingPATENT SIBEL-011 PCT algorithm. Body position and fall count can also be collected and displayed. Body positions unique to labor can be tracked such as sitting, kneeling, hands and knees, and standing. The ANNE® Limb sensor collects data that is displayed on the monitors 112, 113, including the plethysmography waveform, as well as the SpO2 level, pulse rate, and perfusion index. The ANNE® Limb sensor also can measure and transmit data points including peripheral temperature.

[0035] The waveforms and other data sensed by the sensors 105 can be displayed or hidden on the patient monitor 112 display based upon the clinician’s preferences and needs. The patient monitoring screen displays patient demographic information, such as patient type and bed location. It also displays sensor status, including connection and battery life. The patient monitoring screen also has the ability to display and trend early warning scores for patient or fetus deterioration detection and to display vital signs trending over time. The patient monitoring screen includes audio and visual alerts and alarms that are pushed to the central station(s) 120.

[0036] The illustrated embodiment is deployed with the ANNE® sensor suite as discussed above. However, various embodiments may use other types of sensors obtained from other sources. The system 100 is also compatible with many original equipment manufacturer (“OEM”) sensors, including non-invasive blood pressure cuffs, thermometers, and so on.

[0037] The patient monitor 112 allows healthcare users to enter information manually about the patient 110, the care they have provided, and data they have gathered through other means and processes. For example, information such as urine output, level of consciousness, and cervical dilation are relevant to evaluating a comprehensive understanding of the patient and fetal health and labor and delivery status.

[0038] The patient monitor 112 can track and store sensor data and user entered data. The patient monitor 112 can also communicate in real-time, near real-time, or in bulk transfer to the central monitoring station 114. As used in this context, the term “real-time” means that the sensor data is communicated as it is acquired, without delay or buffering. The term “near real-time” means as close to real-time as available computing resources permit.PATENT SIBEL-011 PCT

[0039] A patient / family view screen 200, shown in FIG. 2, is intended to provide patients and families with a user-friendly interface to quickly view patient status. This includes an indication of vital signs status and general labor status. Patients and families can access educational information provided by the healthcare organization to better understand the patient’s care.

[0040] The central monitoring station 114 aggregates real-time or near real-time data as well as stored data from all the patients of a hospital department 125, ward, or a section within a healthcare facility. Data includes vital measurements such as waveforms and physiological parameters, as well as alarms and alerts. The central monitoring station 114 gives clinicians the ability to get in one glance information on the status of all their patients and act accordingly. Clinicians or other caregivers can also zoom in on a given patient’s data to visualize all real-time information as well as stored data. The central monitoring station 114 interfaces as well with the healthcare’s information technology (“IT”) infrastructure, such as the hospital network 130. The central monitoring station 114 shares bi-directionally any data requested by the central or healthcare applications. Clinicians are able to sort patients based on name, location, and risk level.

[0041] The hospital network 130 in the illustrated embodiment includes a variety of computing resources, such as the central server 132, and communications resources, not shown, such as gateways, routers, etc. The patient monitor 112, the central monitoring station 114, and / or the hospital network 130 may communicate between and among themselves over wired, wireless, or both wired and wireless connections using protocols and standards known to the art to be suitable for the given context. The hospital network 130 may include, residing on one or more servers 132, a variety of data stores such as patient histories (“HIS”), patient electronic medical records (“EMR”), and / or clinical information systems (“CIS”).

[0042] The components of the hospital network 130 may be located onsite at the medical facility where the medical care is delivered, or at some other geographical location, or at some combination of the two. For example, some aspects of the hospital network 130 may be allocated cloud resources located in a data center with which the hospital network communicates over public or private networks not shown.PATENT SIBEL-011 PCT

[0043] The user interface of the central monitoring station 114 may be configured to adapt to the care area or section where it is installed according to the clinicians’ needs. The central monitoring station 114 enables up to 64 patients to be monitored remotely or at a central nursing location. This allows for greater interrogation of vital signs by a single healthcare provider or other caregiver across multiple patients in a ward. FIG. 3 depicts the displays 300 in one particular embodiment of the central monitoring station 114. Those in the art having the benefit of this disclosure will appreciate that in some larger medical facilities there may be a plurality of central stations 120 for monitoring multiple patients. For example, in a hospital, each floor may have a central monitoring station 114. A user interface device — i.e. , a keyboard 305 — is shown.

[0044] Returning to FIG. 1 , an abbreviated set of functionality of the central monitoring station 114 may also be provided via a mobile application called Mobile Hub that runs on some kind of personal digital assistant (“PDA”) 140, for example, like a smartphone or a smart tablet. The PDA may run an operating system such as Android or iOS. This allows for healthcare providers to monitor patients remotely throughout the hospital or care facility. Vital signs and other critical information about a patient such as alarms and alerts can be viewed through an app loaded and executing on the PDA 140.

[0045] The integrated care delivery system 100 includes a patient monitoring system 150 at the patient’s bedside 115, portions of which are described above. In some embodiments, patient monitoring system 150 includes an electronic fetal monitor 400, shown applied to the patient 112 in FIG. 4. The electronic fetal monitor 400 contains a plurality of sensors, such as the sensor 405, for monitoring the vital signs of the fetus as well as uterine contractions. The electronic fetal monitor 400 is a small device, typically placed on a pregnant patient’s abdomen, that uses sensors to monitor and record the baby's heart rate during pregnancy, particularly during labor.

[0046] The fetal heartbeat can be detected through various methods depending on the technology of the electronic fetal monitor. Ultrasound can detect the sound of the fetal heartbeat through the abdominal wall. Alternatively, ECG can be used to monitor both the heart rate of the fetus as well as the mother. Another technology uses cardiotocography (“CTG”) to detect the fetal heart rate. Uterine contractions can be detected and monitored using electromyography (“EMG”), tocodynamometer (“TOCO”) technology, or CTG.PATENT SIBEL-011 PCT

[0047] Integrating this sensor into a monitoring app on the patient monitor 112 and / or the central monitoring station 114 provides continuous monitoring of both the mother and the baby. One such monitoring app that may be adapted as described herein is commercially available from Sibel Health, Inc. and sold as the Anne® monitoring app as part of an ANNE® Maternal system.

[0048] Sensor data from the electronic fetal monitor 400 and other sensors such as the ANNE® Chest or ANNE® Limb monitor can be time-synchronized to allow for visual analysis of historical data by a healthcare provider or to enable advanced algorithms. Examples of advanced algorithms include machine learning derived early warning scores for maternal and fetal outcomes which are based on the dynamics of continuous data from a combination of sensors. One representative example of such a screen / view 500 is shown in FIG. 5, although other screens / views may be used.

[0049] A point of care ultrasound (“POCLIS”) device may also be integrated with the patient monitoring system 150. Integrating the POCUS images, video, measurement, annotations, and controls into the patient monitor app allows healthcare practitioners to seamlessly utilize an additional source of information about the mother and fetus. Data download and data synchronization of ultrasound images and data with physiological data can provide additional information for the healthcare provider or can be used for future analysis.

[0050] POCUS data outputs include key screenshots of fetal anatomy, presentation (e.g. breech or cephalic), fetal biometry indicator of fetal growth, health, and gestational age, umbilical artery doppler, placental location and appearance, and characteristics of the amniotic fluid quantality (e.g. deepest vertical pocket), and even future parameters generated by Al algorithms (e.g. automated gestational age). These data outputs will be linked to both fetal and maternal vital signs outputs. Commercially available point of care ultrasound devices, such as the SonoStar UProbe C5PL available from Universal Diagnostic Solutions, Inc., may provide image adjustment, biopsy assistance, measurement, annotation, and image-saving functions, ensuring the healthcare provider has all the tools necessary to make informed decisions quickly and confidently.

[0051] The patient monitoring system 150 may also implement a simplified partograph display 600, shown in FIG. 6, to be used for most labor courses. A partograph is aPATENT SIBEL-011 PCT graphical tool used in obstetrics to monitor the progress of labor. It helps healthcare providers track various parameters, including cervical dilation, fetal heart rate, and uterine contractions over time. By visualizing this information, clinicians can identify deviations from normal labor patterns, which can prompt timely interventions if complications arise. The partograph aims to improve maternal and fetal outcomes by facilitating better management of the labor process.

[0052] In one embodiment, the digital partograph in the patient monitoring system 150 is based on the World Health Organization (“WHO”) Labor Care Guide. The WHO Labor Care Guide is basically a set of recommendations designed to improve the experience of women during childbirth. It focuses on making labor safer and more supportive by promoting respectful care, effective communication, and evidence-based practices. The guide emphasizes the importance of listening to women’s needs, providing emotional support, and ensuring that they receive appropriate medical care throughout the labor process.

[0053] While the core functionality of the sensor suite 105 and the patient monitoring system 150 provides maternal vital signs monitoring, such as electrocardiogram (“ECG”), heart rate (“HR”), respiration rate (“RR”), oxygen saturation (“SpO2”), skin temperature, blood pressure, and more, the patient monitoring system 150 extends this functional to also monitor the fetus with fetal heart rate (“fHR”) and, optionally, fetal ECG. Providing automated, continuous monitoring of both the maternal and fetal physiological data enables automatic population of a large portion of the digital partograph.

[0054] The patient monitoring system 150 allows users to configure a reminder period for the system to remind healthcare providers to enter manually gathered information. Having up to date information in the system helps to ensure that healthcare providers have a complete and accurate picture of the maternal and fetal status and can make timely decisions about possible interventions. For example, an alert can be given if a cervical dilation measurement has not been conducted in a prespecified period of time.

[0055] Alarms and alerts provide real-time notifications to healthcare providers when a patient's condition changes or falls outside of preset parameters. Alarms can be audible sounds or visual messages or flashing lights. Clinicians can adjust alarm settings forPATENT SIBEL-011 PCT specific patients, reducing unnecessary alarms and alarm fatigue. Alarms and alerts can also be silenced or turned off if desired to prevent alarm fatigue.

[0056] In addition to the alarms and alerts provided by the patient monitoring system 150 for vital sign monitoring (e.g. heart rate, blood pressure, respiratory rate, oxygen saturation, and temperature), the patient monitoring system 150 is designed to provide alerts specific and relevant to labor and delivery. The risk associated with labor and delivery to both the mother and the fetus can be described by an Early Warning Score (“EWS”). In the context of labor and delivery, EWS is a tool used to assess a patient's clinical status and identify those at risk of deterioration. EWS typically assigns scores based on vital signs and other clinical indicators, such as: Heart rate, Blood pressure, Respiratory rate, Temperature, Oxygen saturation, and Level of consciousness.

[0057] Each parameter is assigned a score, and the total score helps healthcare providers recognize when a patient may require closer monitoring or intervention. The goal is to detect potential complications early, ensuring timely care for both the mother and the baby. The risk can be stratified into severity bands indicating the relative risk and triggering intervention or other protocols. Risk scores may be relevant to the mother, the fetus, or both.

[0058] In one embodiment, the patient monitoring system 150 generates a risk score based on MEOWS. MEOWS stands for "Modified Early Obstetric Warning System (MEOWS)." It is a tool used in labor and delivery to help healthcare providers identify early signs of potential complications in pregnant patients. The MEOWS criteria typically include: Mental status changes (e.g., confusion, unresponsiveness), Elevated heart rate (tachycardia), Obstetric pain that is unusual or worsening, Worsening hypertension (high blood pressure), Shortness of breath or respiratory distress

[0059] Information used to calculate risk scores can be based on real-time and / or historical data from the sensors as well as real-time and / or historical information manually entered by the healthcare provider. Information derived from historical data may be based on trends, statistical analysis, or other relevant means of analysis. Risk calculations may be based on deep-learning or other Al or machine learning techniques.

[0060] By monitoring these risk measures, healthcare teams can intervene early to prevent serious complications for both the mother and the baby. The ANNE MaternalPATENT SIBEL-011 PCT system can provide risk-stratification enabling targeted and timely response plan development.

[0061] In general, it is contemplated by the present disclosure that the various devices of the labor and delivery communicatively integrated care delivery system 100, including the patient monitor 112, the central monitoring station 114, the electronic fetal monitor 400, POCLIS device, and the sensors 105, all further include electronic components and / or electronic computing devices operable to receive, transmit, process, store, and / or manage patient data and information associated performing the functions of the system as described herein, which encompasses any suitable processing device adapted to perform computing tasks consistent with the execution of computer-readable instructions stored in a memory or a computer-readable recording medium. The present disclosure will primarily discuss those changes and / or additions used to implement the technique disclosed herein.

[0062] It is also contemplated by the present disclosure that the communication connections established as described herein permit communications over other types of wireless networks using alternate hospital wireless communications such as wireless medical telemetry service (“WMTS”), which can operate at specified frequencies (e.g., 1.4 GHz). Wired connections may include Universal Serial Bus (“USB”), serial, coax, canbus, or other types of wired networks. Wireless communication connections can include wireless connections that operate in accordance with, but are not limited to, IEEE802.11 protocol, a Radio Frequency For Consumer Electronics (RF4CE) protocol, ZigBee protocol, and / or IEEE802.15.4 protocol.

[0063] Further, any, all, or some of the devices disclosed herein may be adapted to execute any operating system, including Linux®, UNIX®, Windows Server®, etc., as well as virtual machines adapted to virtualize execution of a particular operating system, including customized and proprietary operating systems. The components of the ANNE Maternal System may be further equipped to facilitate communication with other computing devices over one or more communications links, which may include connections to local and wide area networks, wireless and wired networks, public and private networks, and any other communication network enabling communication in the system.PATENT SIBEL-011 PCT

[0064] Each of the computational components of the labor and delivery communicatively integrated care delivery system 100 may include at least one or more processors; a memory, and a communications interface, all communicating over an internal bus. Those in the art having the benefit of this disclosure will appreciate that the computational components of the labor and delivery communicatively integrated care delivery system 100 may, and probably will, include other components.

[0065] These other components may implement common functionalities, like a power source. For instance, a power source (not shown) may include a self-contained power source such as a battery pack and / or include an interface to be powered through an electrical outlet, either directly or by way of a monitor mount. The power source may also be a rechargeable battery that can be detached allowing for replacement. In the case of a rechargeable battery, a small built-in back-up battery (or super capacitor) can be provided for continuous power to be provided during battery replacement. The power source for some of the computational components may instead, or additionally, include grid power.

[0066] Some of these other components may differentiate network devices for their intended functions. For example, some network devices may be medical devices, such as patient monitors including sensor interfaces through which they may receive sensed data. For another example, some network devices may be part of a cloud computing system and therefore host virtualized components of a virtual machine. Those in the art having the benefit of this disclosure will appreciate still other examples of functionality differentiation among network devices and concomitantly the differentiation among components.

[0067] The one or more processors may be used for controlling the general operations of the computational components of the labor and delivery communicatively integrated care delivery system 100. The one or more processors may be any suitable processor-based resource. They may be, but are not limited to, a central processing unit (“CPU”), a hardware microprocessor, a multi-core processor, a single core processor, a field programmable gate array (“FPGA”), a controller, a microcontroller, an application specific integrated circuit (“ASIC”), a digital signal processor (“DSP”), or other similar processing device capable of executing any type of instructions, algorithms, or software for controllingPATENT SIBEL-011 PCT the operation and performing the functions of respective computational components. In some embodiments, the one or more processors may comprise a processor chipset including, for example and without limitation, one or more co-processors.

[0068] The memories may be single memory devices or one or more memory devices at one or more memory locations that may include, without limitation, one or more of a random-access memory (“RAM”), a memory buffer, a hard drive, a database, an erasable programmable read only memory (“EPROM”), an electrically erasable programmable read only memory (“EEPROM”), a read only memory (“ROM”), a flash memory, hard disk, various layers of memory hierarchy, or any other non-transitory computer readable medium. The memories may be on-chip or off-chip depending on the implementation of the one or more processors.

[0069] The communications interfaces may permit the respective computational component to directly or indirectly (via, for example, a monitor mount) communicate with one or more computing networks and devices, workstations, consoles, computers, monitoring equipment, alert systems, and / or mobile devices (e.g., a mobile phone, tablet, or other hand-held display device). The communications interfaces may include various network cards, interfaces, communication channels, cloud, antennas, and / or circuitry to permit wired and wireless communications with such computing networks and devices.

[0070] The communications interfaces may be used to implement, for example, a BLUETOOTH® connection, a cellular network connection, and / or a WIFI® connection with such computing networks and devices. Example wireless communication connections implemented using the communication interfaces include wireless connections that operate in accordance with, but are not limited to, IEEE802.11 protocol, a Radio Frequency For Consumer Electronics (“RF4CE”) protocol, and / or IEEE802.15.4 protocol (e.g., ZigBee® protocol). In essence, any wireless communication protocol may be used.

[0071] Additionally, the communications interfaces may permit direct (i.e., device-to- device) communications (e.g., messaging, signal exchange, etc.) using, for example, a universal serial bus (“USB”) connection or other communication protocol interface. The communications interfaces may also permit direct device-to-device connection to otherPATENT SIBEL-011 PCT devices such as to a tablet, computer, or similar electronic device; or to an external storage device or memory.

[0072] Note that the various elements of the computational components may be implemented differently in any given embodiment. As a non-limiting example, in one embodiment the one or more processors may be a single microprocessor while the one or more processors may be a processor chipset. Or, one memory may be implemented in a single RAM device while another memory may be implemented in a redundant array of independent disks. Those in the art having the benefit of this disclosure will appreciate still other examples of differences in implementation-specific differences across embodiments.

[0073] The memories may be used to store any type of instructions associated with algorithms, processes, or operations for controlling the general functions and operations of the computational components. The instructions may be any form of software, including, without limitation, firmware, executable applications, etc. Execution of the instructions by the respective one or more processors will impart the functionalities of the computational component associated with the presently disclosed technique as discussed below.

[0074] As used herein, in one sense, the term “remote” means a physically different location than where the patient monitor is located. In one sense, “remote” may mean that the geographical location is physically different from the “local” location. In a second sense, “remote” also means that the location is outside the physical presence of the patient. The term “remote” may also mean a different device — anything not the primary holder of data. This meaning includes a secondary or further device that could be in same proximity / location. For example, a remote monitor in the same place, but maybe that is bigger than the primary one like a large screen on the wall, or tablet that summarizes information but can still be in the same location.

[0075] Accordingly, rather than deploying disparate sensor and display systems or a combination of paper systems and digital, the labor and delivery communicatively integrated care delivery system 100 provides an integrated system for collecting maternal vital signs, fetal heart rate tracing, and point of care ultrasound, auto-populating a digital partograph. This ensures that information is entered in a timely manner and risk isPATENT SIBEL-011 PCT evaluated automatically based on all available information. By providing better monitoring and information for care providers, the system helps minimize unnecessary medical interventions unless they are needed for safety, promoting a more natural labor process when possible. Note that not all embodiments will necessarily exhibit or possess all these advantages. To the extent any given embodiment possesses one or more of these advantages, various embodiments may possess them to different degrees and in different combinations.

[0076] Accordingly, in a first embodiment, a method of monitoring a patient during labor and delivery and a fetus that is being birthed by the patient comprises: receiving physiological parameters of the patient from a physiological sensor; receiving physiological parameters of the fetus from a physiological sensor; receiving user input containing parameters about the patient or fetus; and calculating a risk level based on the patient and fetus physiological parameters and / or user input parameters.

[0077] In a second embodiment, in the method of the first embodiment, the risk level is associated with the patient.

[0078] In a third embodiment, in the method of monitoring in the method of the first embodiment, the risk level is associated with the fetus.

[0079] In a fourth embodiment, in the method of the first embodiment, the risk level is a score.

[0080] In a fifth embodiment, the method of the first embodiment further comprises tracking a historical time series of the patient and fetus physiological parameters.

[0081] In a sixth embodiment, the method of the first embodiment further comprises tracking a historical time series of parameters received from the user about the patient and fetus.

[0082] In a seventh embodiment, the method of the fifth embodiment further comprises determining the risk level based on one or more of the physiological parameters from the historical time series.

[0083] In an eighth embodiment, the method of the sixth embodiment further comprises determining the risk level based on one or more of the historical time series of parameters received from the user.PATENT SIBEL-011 PCT

[0084] In a ninth embodiment, in the method of the first embodiment, the patient and fetus physiological parameters are time synchronized.

[0085] In a tenth embodiment, a communicatively integrated care delivery system for use in monitoring a patient during labor and delivery and a fetus that is being birthed by the patient comprises a sensor suite and a monitor. The sensor suite further comprises: a physiological sensor configured to monitor one or more physiological parameters of the patient; and a physiological sensor configured to monitor one or more physiological parameters of the fetus. The sensor suite is designed to communicate physiological parameters acquired from the patient and the fetus to the monitor.

[0086] In an eleventh embodiment, in the communicatively integrated care delivery system of the tenth embodiment, the monitor further comprises a display.

[0087] In a twelfth embodiment, in the communicatively integrated care delivery system of the eleventh embodiment, the display shows the real-time physiological parameters of the patient and fetus.

[0088] In a thirteenth embodiment, in the communicatively integrated care delivery system of the eleventh embodiment, the display shows a risk level for the patient and / or fetus.

[0089] In a fourteenth embodiment, in the communicatively integrated care delivery system of the eleventh embodiment, the display shows a historical time series of the patient and fetus physiological parameters.

[0090] In a fifteenth embodiment, in the communicatively integrated care delivery system of the eleventh embodiment, the monitor further comprises an input mechanism for a user to enter parameters about the patient and fetus and a display.

[0091] In a sixteenth embodiment, in the communicatively integrated care delivery system of the fifteenth embodiment, the display shows a historical time series of the user entered parameters.

[0092] In a seventeenth embodiment, in the communicatively integrated care delivery system of the tenth embodiment, the patient and fetus physiological parameters are time synchronized.

[0093] In an eighteenth embodiment, the communicatively integrated care delivery system of the eleventh embodiment further comprises an ultrasound device for monitoring the fetus.PATENT SIBEL-011 PCT

[0094] In a nineteenth embodiment, in the communicatively integrated care delivery system of the eighteenth embodiment, the monitor displays the ultrasound information.

[0095] In a twentieth embodiment, in the communicatively integrated care delivery system of the nineteenth embodiment, the ultrasound information comprises video, images, and / or annotations.

[0096] In a twenty-first embodiment, an integrated labor management system is configured to perform the method of the first embodiment.

[0097] In a twenty-second embodiment, a method of monitoring a patient during labor and delivery and a fetus that is being birthed by the patient is substantially as shown and described.

[0098] In a twenty-third embodiment, an integrated labor management system is substantially as shown and described.

[0099] A sensor refers to a component which converts a physical quantity to be measured to an electric signal, for example, a current signal or a voltage signal. The physical quantity may for example comprise electromagnetic radiation e.g., photons of infrared or visible light), a magnetic field, an electric field, a pressure, a force, a temperature, a current, or a voltage, but is not limited thereto.

[0100] The expressions such as “include” and “may include” which may be used in the present disclosure denote the presence of the disclosed functions, operations, and constituent elements, and do not limit the presence of one or more additional functions, operations, and constituent elements. In the present disclosure, terms such as “include” and / or “have”, may be construed to denote a certain characteristic, number, operation, constituent element, component or a combination thereof, but should not be construed to exclude the existence of or a possibility of the addition of one or more other characteristics, numbers, operations, constituent elements, components or combinations thereof.

[0101] As used herein, the article “a” is intended to have its ordinary meaning in the patent arts, namely “one or more.” Herein, the term “about” when applied to a value generally means within the tolerance range of the equipment used to produce the value, or in some examples, means plus or minus 10%, or plus or minus 5%, or plus or minus 1 %, unless otherwise expressly specified. Further, herein the term “substantially” as usedPATENT SIBEL-011 PCT herein means a majority, or almost all, or all, or an amount with a range of about 51 % to about 100%, for example. Moreover, examples herein are intended to be illustrative only and are presented for discussion purposes and not by way of limitation.

[0102] As used herein, to "provide" an item means to have possession of and / or control over the item. This may include, for example, forming (or assembling) some or all of the item from its constituent materials and / or, obtaining possession of and / or control over an already-formed item.

[0103] Unless otherwise defined, all terms including technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present disclosure pertains. In addition, unless otherwise defined, all terms defined in generally used dictionaries may not be overly interpreted. In the preceding, details are set forth to provide a more thorough explanation of the embodiments. However, it will be apparent to those skilled in the art that embodiments may be practiced without these specific details. In other instances, well-known structures and devices are shown in block diagram form or in a schematic view rather than in detail in order to avoid obscuring the embodiments. In addition, features of the different embodiments described hereinafter may be combined with each other, unless specifically noted otherwise. For example, variations or modifications described with respect to one of the embodiments may also be applicable to other embodiments unless noted to the contrary.

[0104] Further, equivalent or like elements or elements with equivalent or like functionality are denoted in the preceding description with equivalent or like reference numerals. As the same or functionally equivalent elements are given the same reference numbers in the figures, a repeated description for elements provided with the same reference numbers may be omitted. Hence, descriptions provided for elements having the same or like reference numbers are mutually exchangeable.

[0105] It will be understood that when an element is referred to as being “connected” or “coupled” to another element, it can be directly connected or coupled to the other element or intervening elements may be present. In contrast, when an element is referred to as being “directly connected” or “directly coupled” to another element, there are no intervening elements present. Other words used to describe the relationshipPATENT SIBEL-011 PCT between elements should be interpreted in a like fashion (e.g., “between” versus “directly between,” “adjacent” versus “directly adjacent,” etc.).

[0106] In the present disclosure, expressions including ordinal numbers, such as “first”, “second”, and / or the like, may modify various elements. However, such elements are not limited by the above expressions. For example, the above expressions do not limit the sequence and / or importance of the elements. The above expressions are used merely for the purpose of distinguishing an element from the other elements. For example, a first box and a second box indicate different boxes, although both are boxes. For further example, a first element could be termed a second element, and similarly, a second element could also be termed a first element without departing from the scope of the present disclosure.

[0107] Use of the phrases “capable of,” “capable to,” “operable to,” “configured to,” or “programmed to” in one or more embodiments, refers to some apparatus, logic, hardware, and / or element designed in such a way to enable the use of the apparatus, logic, hardware, and / or element in a specified manner. Use of the phrase “exceed” in one or more embodiments, indicates that a measured value could be higher than a predetermined threshold (e.g., an upper threshold), or lower than a pre-determined threshold (e.g., a lower threshold). When a pre-determined threshold range (defined by an upper threshold and a lower threshold) is used, the use of the phrase “exceed” in one or more embodiments could also indicate a measured value is outside the pre-determined threshold range (e.g., higher than the upper threshold or lower than the lower threshold). The subject matter of the present disclosure is provided as examples of apparatus, systems, methods, circuits, and programs for performing the features described in the present disclosure. However, further features or variations are contemplated in addition to the features described above. It is contemplated that the implementation of the components and functions of the present disclosure can be done with any newly arising technology that may replace any of the above-implemented technologies.

[0108] Various modifications to the disclosure will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other variations without departing from the spirit or scope of the present disclosure. Throughout the present disclosure the terms “example,” “examples,” or “exemplary” indicatePATENT SIBEL-011 PCT examples or instances and do not imply or require any preference for the noted examples. Thus, the present disclosure is not to be limited to the examples and designs described herein but is to be accorded the widest scope consistent with the principles and novel features disclosed.

[0109] This concludes the detailed description. The particular embodiments disclosed above are illustrative only, as the invention may be modified and practiced in different but equivalent manners apparent to those skilled in the art having the benefit of the teachings herein. Furthermore, no limitations are intended to the details of construction or design herein shown, other than as described in the claims below. It is therefore evident that the particular embodiments disclosed above may be altered or modified and all such variations are considered within the scope and spirit of the invention. Accordingly, the protection sought herein is as set forth in the claims below.

Claims

PATENT SIBEL-011 PCTCLAIMSWhat is claimed:1 . A method of monitoring a patient during labor and delivery and a fetus that is being birthed by the patient, the method comprising: receiving physiological parameters of the patient from a physiological sensor; receiving physiological parameters of the fetus from a physiological sensor; receiving user input containing parameters about the patient or fetus; and calculating a risk level based on the patient and fetus physiological parameters and / or user input parameters.

2. The method of monitoring in claim 1 , wherein the risk level is associated with the patient.

3. The method of monitoring in claim 1 , wherein the risk level is associated with the fetus.

4. The method of monitoring in claim 1 , wherein the risk level is a score.

5. The method of monitoring in claim 1 , further comprising tracking a historical time series of the patient and fetus physiological parameters.

6. The method of monitoring in claim 1 , further comprising tracking a historical time series of parameters received from the user about the patient and fetus.

7. The method of monitoring in claim 5, further comprising determining the risk level based on one or more of the physiological parameters from the historical time series.

8. The method of monitoring in claim 6, further comprising determining the risk level based on one or more of the historical time series of parameters received from the user.PATENT SIBEL-011 PCT9. The method of monitoring in claim 1 , wherein the patient and fetus physiological parameters are time synchronized.

10. A communicatively integrated care delivery system for use in monitoring a patient during labor and delivery and a fetus that is being birthed by the patient comprising: a sensor suite, further comprising: a physiological sensor configured to monitor one or more physiological parameters of the patient; and a physiological sensor configured to monitor one or more physiological parameters of the fetus; and a monitor to which the sensor suite is designed to communicate physiological parameters acquired from the patient and the fetus.

11. The communicatively integrated care delivery system of claim 10, wherein the monitor further comprises a display.

12. The communicatively integrated care delivery system of claim 11 , wherein the display shows the real-time physiological parameters of the patient and fetus.

13. The communicatively integrated care delivery system of claim 11 , wherein the display shows a risk level for the patient and / or fetus.

14. The communicatively integrated care delivery system of claim 11 , wherein the display shows a historical time series of the patient and fetus physiological parameters.

15. The communicatively integrated care delivery system of claim 11 , wherein the monitor further comprises an input mechanism for a user to enter parameters about the patient and fetus and a display.

16. The communicatively integrated care delivery system of claim 15, wherein the display shows a historical time series of the user entered parameters.PATENT SIBEL-011 PCT17. The communicatively integrated care delivery system of claim 10, wherein the patient and fetus physiological parameters are time synchronized.

18. The communicatively integrated care delivery system of claim 11 , further comprising an ultrasound device for monitoring the fetus.

19. The communicatively integrated care delivery system of claim 18, wherein the monitor displays the ultrasound information.

20. The communicatively integrated care delivery system of claim 19, wherein the ultrasound information comprises video, images, and / or annotations.21 . An integrated labor management system configured to perform the method of claim 1.

22. A method of monitoring a patient during labor and delivery and a fetus that is being birthed by the patient substantially as shown and described.

23. An integrated labor management system substantially as shown and described.

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