WO2014051563A1

WO2014051563A1 - Medical sensor cradle

Info

Publication number: WO2014051563A1
Application number: PCT/US2012/057251
Authority: WO
Inventors: Georgios Kokovidis; Clifford M. RISHER-KELLY; Bernd Rosenfeldt; Rand J. Monteleone
Original assignee: Draeger Medical Systems Inc
Current assignee: Draeger Medical Systems Inc
Priority date: 2012-09-26
Filing date: 2012-09-26
Publication date: 2014-04-03
Anticipated expiration: 2015-03-26

Description

Medical Sensor Cradle

TECHNICAL FIELD

[0001] The subject matter described herein relates to a medical sensor cradle for providing isolated power, isolated communication, and display capabilities to a modular array of physiological sensor devices.

BACKGROUND

[0002] Electronic equipment and signal and power transmission lines can be subjected to voltage surges induced by electrostatic discharge, radio frequency transmissions, switching pulses (spikes) and perturbations in power supply. A circuit can also incorporate high voltages by design, in which case it needs safe, reliable means of interfacing its high-voltage components with low-voltage ones. Electrical isolation is a safety issue for medical sensors as they are often in close contact with a patient. Medical sensors without proper power or communication isolation can provide electrical shocks to the wearer of the sensor. Additionally, medical sensors may experience high voltage spikes caused by medical procedures such as electrosurgery (ESU) and cardiac defibrillation, which can damage the medical sensors and related equipment. An electrical-isolator can prevent high voltages or rapidly changing voltages on one side of a circuit from damaging components or distorting transmissions on the other side.

[0003] IEC 60601 is a series of technical standards for the safety and effectiveness of medical electrical equipment, published by the International Electrotechnical Commission. IEC 60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a de-facto

requirement for the commercialization of electrical medical equipment.

[0004] Medical sensors exist which can connect to a computer using a universal serial bus (USB) standard. A drawback is that many of these sensors do not provide for electrical isolation thus endangering the patient. Additionally, while a healthcare provider may wish to analyze data from several different sensors concurrently and in real-time, only a limited number of sensors can be plugged into a typical computer. Special software specific to each sensor must be designed and installed on the computer to receive, process, and display the information.

[0005] The Medical Information Bus (MIB) is another communication standard that suffers from drawbacks. This standard although it has isolation consumes too much power and has not been well adopted in the industry. MIB defines a standard means of connectivity between medical devices and hospital host computers. Typically, the devices can include patient monitors, infusion pumps, ventilators, pulse oximeters and other devices used in operating rooms, intensive care units and emergency rooms. MIB is intended to enable data communications in the acute care environment. MIB is defined by an emerging family of ANSI/IEEE 1073 standards.

[0006] Additionally, current patient monitoring equipment is generally large, difficult to transport, and integrated rather than modular. Further, critical care

environments often have special needs, such as (1) the absolute need to guarantee patient, user and equipment safety; (2) the need for complete standardized plug-and-play operation with no user intervention; and (3) the need to provide open system interoperability to hospital wide information systems. There is a need for smaller, portable, and modular medical monitoring equipment.

SUMMARY

[0007] In one aspect, a system comprises a communication module, a plurality of isolators, and a hub. Each isolator is connected to a port configured to connect to a sensor measuring at least a physiological parameter of a patient. The hub is connected to at least a local host, the communication module, and the plurality of isolators. The isolators provide electrical isolation between the hub and the ports. The hub is configured to receive data from two or more sensors being connected to two or more ports and provide the received data to at least the local host.

[0008] In another aspect, a method comprises receiving first data on a plurality of sensor ports, determining a destination of the received data, and transmitting the first received data to the destination. Each sensor port is connected to a sensor and electrically isolated. The sensors monitor physiological parameters of a patient. The first received data characterizes the physiological parameters. The destination is selected from a group consisting of: at least one of the plurality of sensors and a host.

[0009] In yet another aspect, a system comprises a communication module, a plurality of isolators, and a hub. Each isolator is connected to a port configured to connect to a sensor measuring at least a physiological parameter of a patient. The hub is connectable to at least a local host, the communication module, and the plurality of isolators. The isolators provide electrical isolation between the hub and the ports. The hub is configured to receive data from two or more sensors being connected to two or more ports and provide the received data to at least the local host. [0010] One or more of the following features can be included. The communication module can be wireless. The local host can be a mobile device configured to display at least the provided data. The system can further include a host port and the local host can be connected to the host port. The ports can be Universal Serial Bus (USB) standard. The ports can be Medical Information Bus (MIB) standard. The local host can be configured to derive data from the provided data and display the derived data. The hub can be configured to provide data received from one sensor to a second sensor. The hub can be configured to provide data received from the local host to a sensor.

[0011] The communication module can transmit the provided data to a second host, the second host being an external host. The communication module can receive second data from a second host, the second host being an external host. The system can be simultaneously connected to a local host and an external host. The external host can be a real time view station. The external host can be a detachable mobile device. The mobile device can derive data from the provided data and display at least one of the derived data and the provided data.

[0012] At least one of the sensors can be measuring a physiological parameter of the patient, the sensor can be selected from a group consisting of: electrocardiogram (EKG), blood oxygen sensor (Sp02), temperature sensor, non-invasive blood pressure sensor, invasive blood pressure sensor, carbon dioxide sensor, carbon monoxide sensor, electroencephalography (EEG) sensor, blood glucose sensor, and respiration sensor.

[0013] The system can further comprising a battery configured to provide electrical energy to at least the communication module. The system can further comprise a power adaptor configured to provide electrical power to at least the communication module.

[0014] The wireless communication module can be selected from a group consisting of: WiFi, Bluetooth, cellular, wireless USB, zigbee, mesh network, RFID, and near-field communication. The system can operate on or less than about 2.5 watts of power. The external host can process the provided data, the processing selected from a group consisting of: displaying, storing, and transmitting.

[0015] The method can further comprise receiving second data from the host and providing the received second data to at least one sensor using the respective sensor port. The method can further comprise providing the first received data to a host using a host port. The method can further comprise transmitting the first received data to an external host wirelessly. The provided first received data can be processed, the processing can be selected from a group consisting of: displaying, storing, and transmitting.

[0016] Articles of manufacture are also described that comprise computer executable instructions permanently stored (e.g., non-transitorily stored, etc.) on computer readable media, which, when executed by a computer, causes the computer to perform operations herein. Similarly, computer systems are also described that may include a processor and a memory coupled to the processor. The memory may temporarily or permanently store one or more programs that cause the processor to perform one or more of the operations described herein. In addition, methods can be implemented by one or more data processors either within a single computing system or distributed among two or more computing systems. [0017] The subject matter described herein provides many advantages. The cradle can provide for an interface between commercially available and/or custom components, which cannot currently be combined without creating a custom system, to create a physiological parameter monitoring system with measurement, display, and processing capabilities for a plurality of physiological parameters. Using off the shelf components can allow for design, development, and production costs to be reduced. Further, the monitoring system enabled by the cradle can be modular in terms of the parameters that are measured (e.g., can monitor electrocardiogram (ECG) and/or blood oxygen saturation level, depending on which sensors are connected to the cradle), the processing that is performed on the parameters (e.g., storage, display, alarm detection, etc.), and the user interface (e.g., can easily change the size of the display based on the physiological parameters being measured and the type of data to be displayed). The modularity allows for a cost effective creation of a custom physiological parameter measuring system.

[0018] Additionally, by providing power and communication electrical isolation for the sensors, the current subject matter can provide for adherence to IEC 60601 electrical standards.

[0019] The details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other features and advantages of the subject matter described herein will be apparent from the description and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

[0020] FIG. 1 is a system diagram of an isolated medical sensor cradle; [0021] FIG. 2 is an illustration showing an example mobile device configured as a host;

[0022] FIG. 3A is an illustration showing an external front view of an example cradle;

[0023] FIG. 3B is an illustrations showing an external top view of the example cradle; and

[0024] FIG. 4 is a process flow diagram illustrating a process for determining the destination of data received from a plurality of sensors and providing the data.

[0025] Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION

[0026] FIG. 1 is a system diagram 100 of an isolated medical sensor cradle

102 connected to a host 106 and a plurality of physiological monitoring devices 104i, where i = 1, 2, ..., N. The cradle includes a hub 108 connected to a plurality of isolators 112i where i = 1 , 2, N. Each isolator 112i is connected to a port 114i where i = 1, 2, ..., N. The hub 108 can be connected to a wireless communication module 110. The hub 108 is connected to a host port 115. In general, a hub (e.g., hub 108) expands a single port (e.g., the host port 115) into several (e.g., the plurality of ports 114;) so that there are more ports available to connect devices to the host 106. At least the wireless communication module 110 can be connected to a battery 116, and the cradle 102 can be connected to a power adapter 118. The cradle 102 can additionally contain memory 120.

[0027] The cradle 102 can attach to a plurality of medical sensors 104; (e.g., physiological monitoring devices). The medical sensors 104; measure and acquire physiological parameters. The parameters can include, but are not restricted to, electrocardiogram (EKG), Blood Oxygen (Sp02), temperature, non-invasive blood pressure ( IBP), invasive blood pressure (IBP), Carbon Dioxide (C02), Carbon Monoxide (CO), electroencephalography (EEG), blood glucose, and respiration. The medical sensors 104; can include processors, memory, digital electronics, etc. The medical sensors 104; are the primary interface to a patient's body. They acquire and process the physiological parameters and pass them through each of the isolated communications channels. The wireless communication module 110 can additionally contain a processor and can control and provides a communication channel for the data transfer between the cradle 102 and the host 106. Cradle 102 can contain memory 120 to buffer the physiological data in the event of a loss of communication ability with host 106. Each medical sensor 104; can be considered self contained and perform data processing algorithms prior to sending data to the cradle 102.

[0028] The hub 108, ports 114; and host port 115 can be implemented using any number of data communication standards, such as, but not limited to, the USB standard or the MIB standard. For example, a UART could be used to implement the data communications.

[0029] The isolator 112i is a device designed to transfer electrical signals to provide coupling with electrical isolation between its input and output. The main purpose of an isolator is to prevent high voltages or rapidly changing voltages on one side of the circuit from damaging components or distorting transmissions on the other side. The isolator 112; can be an optical isolator, magnetic isolator, capacitive isolator or another suitable isolator. The isolator can be an integrated circuit housing both a communication isolation and power isolation or any combination of both. [0030] The cradle 102 can connect using the host port 115 to the host 106. The host 106 can be a mobile device such as a smart phone or tablet. The mobile device can run one of a variety of operating systems, for example Android, iOS, WinCE and Linux. The host 106 can be detachable and can include a storage device, which records the physiological parameter data for subsequent data processing and analysis. An example of post processing analysis would be full arrhythmia ECG processing, which is processing that may not be required to be performed in real time. Additionally, the host 106 can be a real time view station.

[0031] The host 106 can display physiological parameter data received from the medical sensors 104; through the cradle 102. FIG. 2 is an illustration 200 showing an example mobile device 205 configured as an host. The device is displaying physiological parameter data received from the medical sensors 104; via the cradle 102. Physiological parameter data can include, for example, ECG 210, Sp02 220, NIBP 230, and temperature 240. Additionally, data derived from the physiological parameter data can also be displayed such as the heart rate 215, blood oxygen saturation level 225, and respiration data 235. The processing to derive the data can be performed either at a medical sensor 104; or on the host 106. The host 106 can connect to the cradle 102 via the host connecter 115 or wireless connection (i.e., use the cradle's wireless communication module 110 to connect wirelessly). The host 106 can, rather than using host port 115, connect to the cradle 102 wirelessly using the wireless communications module 110. The host 106 in this configuration can be referred to as an external host, whereas a host physically connected using the host port 115 can be referred to as a local host.

Additionally, there can be two or more hosts, one can directly connect to the cradle 102 (local host) through the host port 115, and at least one additional host can connect wirelessly (external host). The two or more hosts can provide for similar display, interaction, and processing.

[0032] The host 106 user interface enables a user to interact with the physiological parameter data. For example, a user can scroll through the time dimension of the ECG waveform 210 of FIG. 2 and zoom in and out to inspect the displayed data. The user interface also enables the user to interact with the medical sensors 104;. A user can control functionality of a particular medical sensor 104i, such as instructing the medical sensor 104i to perform a measurement.

[0033] The isolated USB power and communications channels can be bidirectional to allow communication between medical sensors 104i, cradle 102, and host 106. Therefore, the cradle 102 can support two-way data transfer between host 106 and medical sensor 104;. Additionally, the cradle 102 can support two-way data transfer between two or more medical sensors 104;. For example, a QRS synchronization signal can be sent from an ECG monitor to another connected device or ancillary equipment such as a balloon pump. The balloon pump can time its inflation and deflation based on the QRS synchronization signal.

[0034] The cradle 102 also provides an isolated power supply and data communications interface to the physiological monitoring devices. This allows for adherence to the IEC 60601 standard. Since the standard is a de-facto requirement for many markets, the cradle 102 can ensure compliance. The medical sensors 104; do not need to have the isolation capabilities integrated into the medical sensors 104; and thus a wide variety of medical sensors 104; can be used. [0035] The wireless communication module 110 can be based on any acceptable wireless communication technology such as, for example, WiFi, Bluetooth, cellular, wireless USB, Zigbee, mesh network, RFID, and near-field communication.

[0036] Wireless charging technology can be used in place of the power adapter 118. Short distance power transmission is usually based on the principle of magnetic induction. With this technology, power can be transferred when the receiver is close to the transmitter. The cradle can include a wireless power receiver and can be charged by being in physical proximity to a wireless power transmitter. The wireless charging technology can follow the Wireless Power Consortium's Qi low power standard. The Qi low power standard can delivering up to 5 Watts into wireless power receivers. Other wireless power standards are possible.

[0037] The cradle 102 is small, portable, and, due to the integrated battery 116, does not need to have a constant power source. Therefore, the cradle 102 can be used in an ambulating environment.

[0038] The cradle 102 and sensors 104; can use host 106 resources. If the host 106 contains a battery then the battery of the host can be used to power the cradle 102 and medical sensors 104;. Further, a dedicated battery pack can be attached to the cradle 102 to increase the length of operation between charges. If the host 106 has a wireless module, then that wireless module can be used instead of or in addition to the cradle wireless communication module 1 10. For example, if the wireless communication module 1 10 was a WiFi radio, a host with a cellular wireless radio can be used as a LAN to WAN bridge, allowing internet access via a cellular connection. The data transmitted can be encrypted for privacy and HIPAA requirements by the processor in the wireless communications module 1 10.

[0039] The cradle 102 can be used as a standalone device, without requiring the host 106 to be connected to the cradle to provide display and user interface. This can be advantageous to allow the medical sensors 104; to communicate among themselves while no display or additional processing of the data is required. Additionally, the host 106 can be replaced without significant interruption to the system (also known as "hot plugging"). For example, a smart phone can be disconnected and replaced by a tablet or laptop computer without significantly interrupting the processing. This can be desirable when additional data interaction and/or analysis is to be performed or when a larger display screen is required. Further, the host 106 can be connected to the cradle 102 using the host port 115 and then disconnected from the host port 115 and the connection can be re-established using the wireless communications module 110 allowing a physician to take the host 106 and monitor the patient's physiological parameters remotely.

[0040] FIG. 3A is an illustration 300 showing an external front view of an example cradle 102. FIG. 3B is an external top view of the example cradle 102. The cradle 102 is connected to an host 106 via an host port 115. The host 106 is displaying ECG and Sp02 waveform physiological parameter data. Four USB ports 114₁, 114₂, 114₃, and 114₄ are placed such that sensor cables can be inserted. Four corresponding medical sensors 104i, 104₂, 104₃, and 104₄ are connected to their respective USB ports.

[0041] The example cradle 102 can run on 2.5 Watts (i.e., one standard USB power load). 100 to 200 mW of power can be provided for each of four (4) pluggable sensors. Since the isolators may only be 50% efficient, each of the channels will take a maximum of 400 mW from the battery. This means the four medical sensors 104;

combined can draw up to 1.5 Watts of power. The remaining 1 Watt provides power to the wireless module 110, USB hub 108, and for charging the battery 116. The 2.5 Watt power load corresponds to the USB 2.0 standard. Different underlying data communication standards, such as later versions of the USB standard, can have higher maximums.

[0042] FIG. 4 is a process flow diagram 400 illustrating a process for determining the destination of data received from a plurality of medical sensors 104; and providing the data. At 410, data is received on a plurality of ports 114; from physiological parameter sensors. The ports 114; can include USB, MIB, or another standard of data communication. Each port 114;, is electrically isolated. The parameters can include but are not restricted to ECG, Sp02, temperature, Invasive Blood Pressure (IBP), Carbon Dioxide (C02), Carbon Monoxide (CO), Electroencephalography (EEG), blood glucose, respiration, and NIB P. At 420, a destination of the received data is determined. The destination can include a local or external host 106, memory 120 in cradle or another medical sensor 104;. At 430, the data is transmitted to the destination. The transmission can be performed using a host port 115, isolated port 114;, or a wireless communication module 110. Optionally, at 440, data can be received from a host 106, the data can be received using a host port 115 or wirelessly. Optionally, at 450, the data received from the host can be provided to at least one of the plurality of medical sensors 104; using the corresponding port 114;.

[0043] Various implementations of the subject matter described herein may be realized in digital electronic circuitry, integrated circuitry, specially designed ASICs (application specific integrated circuits), computer hardware, firmware, software, and/or combinations thereof. These various implementations may include implementation in one or more computer programs that are executable and/or interpretable on a

programmable system including at least one programmable processor, which may be special or general purpose, coupled to receive data and instructions from, and to transmit data and instructions to, a storage system, at least one input device, and at least one output device.

[0044] These computer programs (also known as programs, software, software applications or code) include machine instructions for a programmable processor, and may be implemented in a high-level procedural and/or object-oriented programming language, and/or in assembly/machine language. As used herein, the term "machine-readable medium" refers to any computer program product, apparatus and/or device (e.g., magnetic discs, optical disks, memory, Programmable Logic Devices (PLDs)) used to provide machine instructions and/or data to a programmable processor, including a machine-readable medium that receives machine instructions as a machine- readable signal. The term "machine-readable signal" refers to any signal used to provide machine instructions and/or data to a programmable processor.

[0045] To provide for interaction with a user, the subject matter described herein may be implemented on a computer having a display device (e.g., a CRT (cathode ray tube), LCD (liquid crystal display), light emitting diode (LED), organic LED, electrophoretic, and/or 3D monitor) for displaying information to the user and a keyboard and a pointing device (e.g., a mouse or a trackball) by which the user may provide input to the computer. Other kinds of devices may be used to provide for interaction with a user as well; for example, feedback provided to the user may be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback); and input from the user may be received in any form, including acoustic, speech, or tactile input (including gesture and multi-touch capability).

[0046] The subject matter described herein may be implemented in a computing system that includes a back-end component (e.g., as a data server), or that includes a middleware component (e.g., an application server), or that includes a front- end component (e.g., a client computer having a graphical user interface or a Web browser through which a user may interact with an implementation of the subject matter described herein), or any combination of such back-end, middleware, or front-end components. The components of the system may be interconnected by any form or medium of digital data communication (e.g., a communication network). Examples of communication networks include a local area network ("LAN"), a wide area network ("WAN"), and the Internet.

[0047] The computing system may include clients and servers. A client and server are generally remote from each other and typically interact through a

communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other.

[0048] Although a few variations have been described in detail above, other modifications are possible. For example, the logic flow depicted in the accompanying figures and described herein do not require the particular order shown, or sequential order, to achieve desirable results. Other embodiments may be within the scope of the following claims.

Claims

WHAT IS CLAIMED IS:

1. A system comprising:

a communication module;

a plurality of isolators, each isolator connected to a port configured to connect to a sensor measuring at least a physiological parameter of a patient; and

a hub connected to at least a local host, the communication module, and the plurality of isolators; the isolators providing electrical isolation between the hub and the ports, the hub configured to receive data from two or more sensors being connected to two or more ports and provide the received data to at least the local host.

2. The system as in claim 1, wherein the communication module is wireless.

3. The system as in any of the preceding claims, wherein the local host is a mobile device configured to display at least the provided data.

4. The system as in any of the preceding claims, wherein the system further includes a host port and the local host is connected to the host port.

5. The system as in any of the preceding claims, wherein the ports are Universal Serial Bus (USB) standard.

6. The system as in any of the preceding claims, wherein the ports are Medical Information Bus (MIB) standard.

7. The system as in any of the preceding claims, wherein the local host is configured to derive data from the provided data and display the derived data.

8. The system as in any of the preceding claims, wherein the hub is configured to provide data received from one sensor to a second sensor.

9. The system as in any of the preceding claims, wherein the hub is configured to provide data received from the local host to a sensor.

10. The system as in any of the preceding claims, wherein the communication module transmits the provided data to a second host, the second host being an external host.

11. The system as in any of the preceding claims, wherein the communication module receives second data from a second host, the second host being an external host.

12. The system as in any of the preceding claims, wherein the system is

simultaneously connected to a local host and an external host.

13. The system as in any of claims 10-12, wherein the external host is a real time view station.

14. The system as in any of the preceding claims, wherein the external host is a detachable mobile device, the mobile device comprising:

at least one data processor; and

memory storing instructions which, when executed by the at least one data processor, causes the at least one data processor to perform operations comprising:

derive data from the provided data; and

display at least one of the derived data and the provided data.

15. The system as in any of the preceding claims, wherein at least one of the sensors is measuring a physiological parameter of the patient, the sensor being selected from a group consisting of: electrocardiogram (EKG), blood oxygen sensor (Sp02), temperature sensor, non-invasive blood pressure sensor, invasive blood pressure sensor, carbon dioxide sensor, carbon monoxide sensor, electroencephalography (EEG) sensor, blood glucose sensor, and respiration sensor.

16. The system as in any of the preceding claims, further comprising: a battery configured to provide electrical energy to at least the communication module.

17. The system as in any of the preceding claims, further comprising:

a power adaptor configured to provide electrical power to at least the

communication module.

18. The system as in any of claims 2-17, wherein the wireless communication module is selected from a group consisting of: WiFi, Bluetooth, cellular, wireless USB, zigbee, mesh network, RFID, and near-field communication.

19. The system as in any of the preceding claims, wherein the system operates on or less than about 2.5 watts of power.

20. The system as in any of the preceding claims, wherein the external host processes the provided data, the processing selected from a group consisting of: displaying, storing, and transmitting.

21. A method implemented by at least one data processor coupled to memory, comprising:

receiving first data on a plurality of sensor ports, each sensor port connected to a sensor and electrically isolated, the sensors monitoring physiological parameters of a patient, the first received data characterizing the physiological parameters;

determining a destination of the received data, the destination selected from a group consisting of: at least one of the plurality of sensors and a host;

transmitting the first received data to the destination.

22. The method of claim 21 , further comprising:

receiving second data from the host; and

providing the received second data to at least one sensor using the respective sensor port.

23. The method as in any one of claims 21-22, wherein at least one of the sensors is measuring a physiological parameter of the patient, the sensor being selected from a group consisting of: electrocardiogram (EKG), blood oxygen sensor (Sp02), temperature sensor, non-invasive blood pressure sensor, invasive blood pressure sensor, carbon dioxide sensor, carbon monoxide sensor, electroencephalography (EEG) sensor, blood glucose sensor, and respiration sensor.

24. The method as in any one of claims 21-23, further comprising:

providing the first received data to a host using a host port.

25. The method as in any one of claims 21-24, further comprising:

transmitting the first received data to an external host wirelessly.

26. The method as in any one of claims 21-25, wherein the provided first received data is processed, the processing selected from a group consisting of: displaying, storing, and transmitting.

27. The method as in any one of claims 21-26, wherein the ports are Universal Serial Bus (USB) standard.

28. The method as in any one of claims 21-26, wherein the ports are Medical Information Bus (MIB) standard.

29. A non-transitory computer readable storage medium comprising executable instructions for executing any of claims 20-28.

30. A system comprising:

a communication module;

a plurality of isolators, each isolator connected to a port configured to connect to a sensor measuring at least a physiological parameter of a patient; and a hub connectable to at least a local host, the communication module, and the plurality of isolators; the isolators providing electrical isolation between the hub and the ports, the hub configured to receive data from two or more sensors being connected to two or more ports and provide the received data to at least the local host.