System and method for patient identification in a remote monitoring system

A patient monitoring system for remote monitoring of medical devices. The system includes a medical device, a patient identification device and a wireless relay module. The relay module receives patient identification information from the patient identification device and medical device identification from the medical device via a wireless relay network, and transmits this information to the remote monitoring device via an internet-accessible wireless communications network. The remote monitoring device returns an acknowledgement status to the relay module, which the relay module transmits to the medical device. Upon receipt of an acknowledgment status indicating that the patient's use of the medical device is authorized, the medical device transmits medical device data to the relay module via the wireless relay network, and the relay module relays the medical device data to the remote monitoring device via the internet-accessible wireless communications network.

FIELD OF THE INVENTION

The present invention is directed to a system and method for identifying a patient in a remote monitoring system monitoring medical devices, and more particularly, to a system and method for associating the patient with a particular medical device before remote monitoring of that medical device begins.

BACKGROUND OF THE INVENTION

In critical care and home care health service centers including hospitals, clinics, assisted living centers and the like, care giver-patient interaction time is at a premium. Moreover, rapid response times by care givers to significant health conditions and events can be critical. Systems of centralized monitoring have been developed to better manage care giver time and patient interaction. In such systems, physiological data from each patient is transmitted to a centralized location. At this centralized location, a single or small number of technicians monitor all of this patient information to determine patient status. Information indicating a patient alarm condition will cause the technicians and/or system to communicate with local care givers to provide immediate patient attention, for example via wireless pagers and/or cell phones, and/or by making a facility-wide audio page.

Implementing such centralized monitoring systems using wireless networks may present a number of difficulties. In order to effectively monitor patient status using information provided by a variety of medical devices that may be dynamically assigned to patients in a variety of rooms and on a variety of floors in a facility, it would be desirable to establish communications between the medical devices and the centralized location by means of a local area network such as, for example, a “WiFi” network based on IEEE 802.11 standards. However, as such networks are typically already in place in facilities to support a variety of other functions (for example, physician access to electronic medical records (EMRs), facility administrative systems and other functions), it is often undesirable to secure sufficient local area network access for the purpose of providing centralized monitoring. Moreover, when a patient is located remotely from a critical care health service center (for example, at home), access to traditional local area network facilities such as a WiFi network may be unavailable or not sufficiently reliable to support critical care monitoring applications.

As an alternative to conventional WiFi or IEEE 802.11-based local area networks, ZIGBEE networks based on the IEEE 802.15.4 standard for wireless personal area networks have been used for collecting information from a variety of medical devices in accordance with IEEE 11073 Device Specializations for point-of-care medical device communication, including for example pulse oximeters, blood pressure monitors, pulse monitors, weight scales and glucose meters. See, e.g.,ZIGBEE Wireless Sensor Applications for Health, Wellness and Fitness, the ZIGBEE Alliance, March 2009, which is incorporated by reference herein in its entirety. ZIGBEE networks provide the advantage of being dynamically configurable, for example, in “self-healing” mesh configurations, and operating with low power requirements (enabling, for example, ZIGBEE transceivers to be integrally coupled to the medical devices under battery power). However, transmission ranges between individual ZIGBEE transceivers are generally limited to no more than several hundred feet. As a consequence, such networks are unusable for centralized monitoring locations located off-site. Also, in accordance with applicable patient data privacy provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), communication of information between the monitored medical devices and the central monitoring location must be done securely.

It is of course critical to the monitoring process that patients are accurately identified in association with the particular medical devices that they are using before treatment and monitoring begin. Challenges exist in identifying patients remotely in “real time” as care providers are about to initiate treatment, while preserving patient confidentiality and privacy (for example, in accordance with HIPAA requirements).

SUMMARY OF THE INVENTION

The present invention is directed to a patient monitoring system for remotely monitoring medical devices used by patients. The system includes at least one medical device for use on or by a patient, at least one patient identification device for identifying the patient and at least one wireless relay module for providing networked communications between at least one medical device and a remote monitoring device. The patient identification device may be, for example, formed as an integral component of, fixedly attached to, coupled (wireless or wired) or disposed separate to the medical device.

In accordance with a preferred embodiment of the invention, the one or more medical devices (including but not limited to, respirators, enteral feeding devices, pulse oximeters, blood pressure monitors, pulse monitors, weight scales and glucose meters) are provided at a patient facility. An interface circuit is coupled to each medical device, and is configured for communicating with the one or more wireless relay modules via a wireless relay network. The wireless relay modules communicate with the remote monitoring device over an internet-accessible wireless communication network, and preferably, over a wireless wide-area network (WWAN) such as a mobile telephone data network including (for example, based on a Global System for Mobile Communications (GSM) or Code Division Multiple Access (CDMA) cellular network or associated wireless data channels). For compliance with HIPAA regulations, for example, communications over each of the wireless networks are preferably conducted securely.

Each of the plurality of wireless relay modules includes a first receiver capable of wirelessly receiving medical device data from respective interface circuits via the wireless relay network, a first transmitter capable of wirelessly transmitting medical device data to another one of the wireless relay modules over the wireless relay network, a second transmitter capable of wirelessly transmitting medical device data over an internet-accessible wireless communications network, a second receiver capable of wirelessly receiving medical device data over the internet-accessible wireless communications network, a controller coupled to the first and second transmitters and receivers, and a memory device coupled to the controller. As used herein, “medical device data” and “data” as generally used herein means data from or about the medical device including, for example, medical device identification, medical device software, medical device settings or status information (including alarm information and/or alarm priority), patient identification information, patient personal identification number(s) “PIN(s)”, patient prescriptions, and/or patient medical and/or physiological data as is collected, produced and/or generated by at least one of the medical device and patient identification device.

The controller is configured to determine access status of the internet-accessible wireless communications network, and to select one of the first or second transmitters based on that status. For example, when the status indicates that the internet-accessible wireless communications network is accessible to the wireless relay module, the controller selects the second transmitter for transmitting medical device data transmitted by the interface circuit to the remote monitoring device. When the status indicates that the internet-accessible wireless communications network is not accessible, the controller selects the first transmitter for transmitting the medical device data to another one of the wireless relay modules. In this manner, another attempt to transmit the medical device data over the internet-accessible wireless communication network can be attempted by this other wireless relay module (and potentially additional ones of the wireless relay modules) until a successful transmission to the remote monitoring device is achieved.

The relay module is further configured to receive identification information from the at least one patient identification device identifying a patient and identification information identifying at least one medical device via the first receiver, to transmit this information or a portion thereof to the remote monitoring device via the internet-accessible wireless communications network, to receive an acknowledgement status from the remote monitoring device via the internet-accessible wireless communications network, and to transmit the acknowledgement status to the medical device over the wireless relay network. Upon receipt of an acknowledgment status indicating that the patient's use of the medical device is authorized, the medical device is configured to transmit medical device data corresponding to an output of at least one sensor of the medical device to the relay module. The relay module relays the medical device data to the remote monitoring device over the internet-accessible wireless communications network.

DETAILED DESCRIPTION OF THE INVENTION

Reference will now be made in detail to exemplary embodiments of the invention, including the best modes contemplated by the inventors for carrying out the invention. Examples of these exemplary embodiments are illustrated in the accompanying drawings. While the invention is described in conjunction with these embodiments, it will be understood that it is not intended to limit the invention to the described embodiments. Rather, the invention is also intended to cover alternatives, modifications, and equivalents as may be included within the spirit and scope of the invention as defined by the appended claims.

In the following description, specific details are set forth in order to provide a thorough understanding of the present invention. The present invention may be practiced without some or all of these specific details. In other instances, well-known aspects have not been described in detail in order not to unnecessarily obscure the present invention.

For the purpose of illustrating the present invention, exemplary embodiments are described with reference toFIGS. 1-7.

A diagram of an exemplary architecture100for a system for monitoring medical devices in accordance with the present invention is illustrated inFIG. 1. One or more medical devices10are provided at a patient facility20for monitoring the medical condition and/or administering medical treatment to one or more patients. Patient facility20may comprise a critical care health service center (for example, including hospitals, clinics, assisted living centers and the like) servicing a number of patients, a home facility for servicing one or more patients, or a personal enclosure (for example, a backpack) that may be attached to or worn by an ambulatory patient. Associated with each medical device10is an interface circuit15that includes a transceiver having one or more of a transmitter and/or a receiver for respectively transmitting and receiving signals in a facility-oriented wireless network such as, for example, a Low-Rate Wireless Personal Area Networks or “LR-WPAN,” ZIGBEE network or another low-power personal area network such as a low power BLUETOOTH network, existing or presently under development or consideration. See, e.g., Houda Labiod et al.,Wi-Fi, Bluetooth, Zigbee and WiMax, Springer 2010, which is incorporated by reference herein in its entirety. It should be understood that interface circuit15may be contained within or disposed external to medical device10in accordance with the present invention. Also provided within the patient facility20are one or more relay modules30a.

As described in greater detail with regard toFIG. 3(a), each relay module30aincludes a first transceiver31for receiving signals from and transmitting signals to the interface circuits15or other relay modules30,30ain the facility-oriented wireless network. Each relay module30a, as depicted inFIG. 3(a), further includes a second transceiver32for wirelessly transmitting signals to and receiving signals from an access point40via a wireless wide-area network or “WWAN”. Suitable WWANs for use with the present invention may include, for example, networks based on a Global System for Mobile Communications (GSM) or Code Division Multiple Access (CDMA) cellular network or associated with the 2G, 3G, 3G Long Term Evolution, 4G, WiMAX cellular wireless standards of the International Telecommunication Union Radiocommunication Sector (ITU-R). See, e.g., Vijay Garg,Wireless Communications&Networking, Morgan Kaufmann 2007, which is incorporated by reference herein in its entirety for all purposes. For compliance with HIPAA regulations, communications over each of the facility-oriented wireless networks and WWAN are preferably conducted securely using, for example, using a Secure Sockets Layer (SSL) protocol or a Transport Layer Security (TLS) protocol.

As illustrated inFIG. 1, the exemplary architecture100may further include one or more wireless patient identification devices17in communication with one or more of the relay modules30aand/or medical devices10in proximity to the patient identification device17via the interface circuits15and17aoperating over the facility-oriented wireless network. Alternatively, a wireless patient identification receiver may be integrated with each medical device10, and access the facility-oriented wireless network via an associated interface circuit15. The wireless patient identification devices17each receive patient identification data from a patient in proximity to the device17that uniquely identifies the patient using one of a variety of commercially-available sensors. For example, each patient identification device17may include a camera or other optical scanner and associated circuitry for sensing a barcode (for example, a UPC code or a QR matrix barcode) attached to or otherwise uniquely associated with a patient, such as a patient's wristband. Alternatively, each patient identification receiver17may include a radio-frequency identification (RFID) sensor and associated circuitry for sensing an RFID tag embedded in the patient wristband, or another commercially-available radio-frequency sensor capable of sensing an identification signal generated by a radio-frequency transmitter embedded in the patient wristband or otherwise provided as attached to or in proximity to the patient. Finally, each device17may in addition or instead include a commercially-available biometric sensor and associated circuitry for patient identification (for example, including one or more of a fingerprint reader, a retinal scanner or a vein-pattern scanner).

For improved efficiencies in centralized monitoring of critical care and home care health service centers, it may be desirable to provide a single “off-site” centralized monitoring location for monitoring several geographically-dispersed critical care health service centers. The exemplary architecture100ofFIG. 1has a suitable access point40that includes an inbound web server41that incorporates or otherwise has access to a transceiver for communicating with the relay modules30aover the WWAN. Medical device data received by the inbound web server41over the WWAN is forwarded to a secure data storage server42, which is configured for example to log the received data in association with identification information of the associated medical devices. An outbound web server43is configured, for example, to receive and qualify data retrieval requests submitted by one or more of remote monitoring devices61,62and63over a broad-band network50(for example, over the Internet), to request associated medical device data to be retrieved from the secure data storage server42, and to format and transmit the retrieved medical device data to the one or more remote monitoring devices61,62and63for display on associated device displays. It should be understood that any architecture for the access point40that enables the receipt, storage and retrieval of medical device data on a device display of the one or more remote monitoring devices61,62and63is suitable for use in conjunction with the present invention. As was previously described infra, “medical device data” and “data” as generally used herein means data from or about the medical device including, for example, medical device identification, medical device software, medical device settings or status information (including alarm information and/or alarm priority), patient identification information, patient personal identification number(s) “PIN(s)”, patient prescriptions, and/or patient medical and/or physiological data as is collected, produced and/or generated by at least one of the medical device and patient identification device.

Thus, and as will be further described herein with reference toFIGS. 2-7, the remote monitoring system ofFIG. 1is capable of obtaining patient identification information to be associated with a particular medical device, securely transmitting the patient identification information with medical device identification information of the associated medical device to verify that the association of the patient with the medical device is authorized, and beginning operation of the medical device and monitoring of medical data generated by the medical device once authorization has been received.

FIG. 2presents a block diagram that further illustrates exemplary components of the inventive architecture that are located within or otherwise associated with the patient facility20ofFIG. 1. InFIG. 2, a number of interface circuits15,17aand relay modules30,30aare arranged in a wireless relay network16within the patient facility20. The interface circuits15,17aand relay modules30,30aare configured to communicate with one another via associated wireless links. In a preferred embodiment of the present invention represented inFIG. 2, the network16is a network based on the IEEE 802.15.4 standard, for example, such as a ZIGBEE network, a WIRELESSHART network and/or a MIWI network. However, the wireless relay network16may be organized according to a variety of other wireless local area network (WLAN) or WPAN formats including, for example, WiFi WLANs based on the IEEE 802.11 standard and/or BLUETOOTH WPANs based on the IEEE 802.15.1 standard.

In the illustrated wireless relay network16, each of the interface circuits15,17aincludes a communications interface such as, for example, a wired communications interface, to an associated medical device10or patient identification device17. In addition, each of the relay modules30,30aincludes at least one transceiver configured to communicate with other relay modules30,30ain the wireless relay network16. Relay modules30afurther include at least a second transceiver for communicating over the WWAN with the access point40.

The use of a ZIGBEE mesh network for network16provides the advantages of being self-configurable when one or more interface circuits15,17aand/or relay modules30,30aare added to the network, and self-healing when one or more interface circuits15,17aand/or relay modules30,30aare removed from or otherwise disabled in the network. Sub-groupings of the interface circuits15,17aand relay modules30,30amay be provided in a defined geographic space (for example, on an individual floor or within a region of a floor in a multi-floor home or care facility).

FIG. 3(a) provides a block diagram illustrating exemplary components of a relay module30a. The relay module30aofFIG. 3(a) includes a first transceiver31for wirelessly communicating with interface circuits15,17aand other relay modules30,30ain the WLAN or WPAN network16ofFIG. 2via an antenna31a. The relay module30afurther includes a second transceiver32for wirelessly communicating with the access point40over the WWAN via an antenna32a. Each of the transceivers31,32is in communication with a data processing circuit33, which is configured to operate under the control of a processor34to accept medical device data received by the transceivers31,32and to store the received medical device data at least temporarily in a buffer element35a. In addition, the data processing circuit33is further configured to retrieve data from the buffer element35aunder the direction of the processor34and provide the retrieved data to a selected one of the transceiver31or transceiver32for transmission. One or more of the data processing circuit33and/or controller34may also preferably include commercially available encryption circuitry for encrypting data to be sent by the transceivers31,32and to decrypt data received by the transceivers31,32, in accordance for example with HIPAA requirements.

In order to make a selection, the processor34is configured to communicate with respective status modules31b,32bof the transceivers31,32in order to determine a communications status of each of the transceivers31,32. Longer term data storage may preferably be provided by a memory35b, for example storing instructions for the controller34, data encryption/decryption software for one of more of the data processing circuit33and/or controller34, a patient identification directory identifying patients using each of the medical devices10, and the like.

The processor34is also preferably in communication with an input/output circuit36, which provides signals to one or more display elements of the relay module30a, for example, for indicating a start-up or current status of the relay module30a, including communication or connection status with the WLAN or WPAN network16and WWAN. Input/output circuit36may also be configured to provide signals to indicate an A/C power loss, and or to be responsive to signals provided by one or more input devices provided in proximity to the one or more display elements.

Relay module30amay preferably be provided as a small physical enclosure with an integral power plug and power supply circuit, such that the relay module30amay be directly plugged into, externally powered and physically supported by a conventional wall outlet providing commercial A/C power. Relay module30amay also preferably include a battery back-up circuit (not shown) to provide uninterrupted power in the event of A/C power outage of short duration. Battery back-up may also be advantageous, for example, for using the relay module30ain an ambulatory mode that enables the patient to move within and potentially at a distance from the facility20, for example, with a medical device10that is an ambulatory enteral feeding device. In this configuration, for example, the medical device10, the interface circuit15and relay module30may be conveniently carried in a patient-wearable backpack.

FIGS. 3(b)-3(d) respectively illustrate top, front and side views of an exemplary configuration37for the relay module30a. Configuration37includes a housing37a, which is shown inFIGS. 3(b)-3(d) configured essentially as a rectangular box or prism. It should however be noted that the housing may alternatively be configured in any of a variety of three-dimensional shapes having a sufficient interior volume for housing the associated circuits, having a sufficient area37con a front panel37bof the housing37afor locating a control panel38(as further illustrated inFIG. 3(e)), and having a sufficient area on a rear panel37dfor providing a receptacle support37eand power plug37ffor supportably plugging the module configuration37into a conventional power outlet. The power plug37fmay also be provided in a modular and replaceably removable configuration enabling power plugs37fto be configured according to a variety of international standards to be easily provided to the configuration37.

FIG. 3(e) illustrates an exemplary control panel38of module configuration37. The exemplary control panel38preferably includes, for example, a power switch38afor powering and/or de-powering the module configuration37after it has been plugged into the conventional wall outlet or equipped with a charged battery back-up subsystem. In addition, the control panel38preferably includes an alarm switch38bwhich allows a user to mute and/or de-mute an audible alarm (for example, a conventional buzzer, not shown) which is coupled to an alarm circuit (not shown) that is configured to issue an alarm when A/C power to the module configuration37has been interrupted and/or when other medical device or remote monitoring system-level alarms occur. The control panel38also includes an A/C power indicator38cwhich may preferably be provided as one or more light-emitting diode (LED) indicator segments which are activated when A/C power has been provided to the module configuration37. Optionally, the indicator38cmay be intermittently activated when A/C power is lost (for example, by means of back-up battery power) to signal the loss of A/C power.

The exemplary control panel38ofFIG. 3(e) also includes a battery indicator38dto indicate a status of the battery back-up circuit. For example, and as illustrated inFIG. 3(e), the battery indicator38dmay preferably include indicator segments38hwhich may be selectively activated to indicate a capacity of the back-up battery. Indicator segments38hmay also be preferably provided as LED segments. Each of the segments38hmay, for example, be activated to indicate that the back-up battery is fully charged, and ones of the segments38hmay be progressively deactivated (for example, proceeding downwardly from an uppermost one of the segments38h) as battery power is drawn down. In the event that remaining battery power is insufficient to operate the module configuration37, each of the segments38may be deactivated. Alternatively, the indicator segments38hmay be provided as multicolor LED segments (for example, red and green), and ones of the segments38hbe illuminated as green and progressively deactivated until reaching a first low power threshold, and then illuminated as red and progressively activated as power is further diminished so that all LED segments are illuminated when battery power is no longer sufficient to power the module configuration37.

As further illustrated inFIG. 3(e), the control panel38may further include an indicator38eto indicate a status of the WLAN or WPAN network16. Similarly to the A/C power indicator38c, the WLAN/WPAN network status indicator38emay be activated when the WLAN/WPAN network status is active or accessible, and either de-activated or intermittently activated when the WLAN/WPAN network status is inactive or inaccessible. Finally, a WWAN indicator38jmay be provided to indicate a status of access to the WWAN network. As depicted inFIG. 3(e), the indicator38jincludes indicator elements38f,38gfor indicating the WWAN network status. In this configuration, for example, the indicator element38fmay be configured with a green LED indicator element that is activated when the WWAN network status is active or accessible, and the indicator element38gmay be configured with a red LED indicator element that is activated when the WWAN network is inactive or inaccessible (for example, when a signal strength of the WWAN network available to the module configuration37is insufficient to support communications). Optionally, the indicator element38fmay be intermittently activated when the signal strength of the WWAN network available to the module configuration37is marginally sufficient to support communications. Alternatively or in addition, one or more of elements38f,38gmay each comprise a single bi-color LED. Indicators of the module configuration37such as indicators38e-38hand38jmay be electrically connected to the input-output circuit36depicted inFIG. 3(a).

In addition, the control panel38may optionally include microphone and speaker elements (not shown) that enable the module configuration37to be operated in a voice communication mode to allow for voice communication, for example, between an operator and a help desk technician in event of a trouble condition reported by one of the medical devices10. Alternatively or in addition, the control panel38may include one or more of a camera element (not shown) and/or a display element (not shown) to be operated in a visual communication mode. For example, the camera element may be used to transfer images from displays of one or more medical devices10to one of the remote monitoring devices61,62and63ofFIG. 1, or alternatively or in addition as a patient identification device as father described herein. Finally, the control panel38may include a synchronization switch38k, which may be used as further described herein to initiate a process for associating patient identification information with identification information of a medical device10.

FIG. 4presents a flow diagram400illustrating an exemplary method of operation for the architecture according toFIG. 1and relay module30,30acomponents ofFIGS. 2 and 3(a), relating to the transmission of medical device data obtained from a medical device10to the access point40. First, at step402of the method400, the medical device data is received at a first one of the relay modules30afrom one of the interface circuits15and/or other relay modules30,30aover the wireless relay network16. At step404, the processor34of the one relay module30adetermines whether the WWAN is accessible by that relay module30a.

The determination of step404may be carried out in a variety of manners. For example, the processor34may interrogate the status module32bof the transceiver32at the time of the receipt of the medical device data to determine a status of access for the transceiver32to the WWAN (for example, as the result of the transceiver32detecting an access signal of the WWAN having adequate signal strength). Alternatively, the processor34may interrogate the status module32bat a different time including, for example, at system start-up and/or intermittently or periodically (for example, hourly), and maintain a status indicator such as in the buffer element35aor another storage element to be retrieved at the time of receipt of the medical data. As yet another alternative, the relay module30,30amay be assigned a predetermined, fixed role within the network16. For example, relay modules30ain the network16may be assigned a data routing assignments by a controller or “master” relay module. By definition, the WWAN status for relay module30that does not possess WWAN access capability shall have a fixed status of “WWAN inaccessible.”

If, as provided for in step404, the status module32bindicates that the WWAN is accessible by the transceiver32, the processor34will proceed to step406to instruct the data processing circuit33of the one relay module30to retrieve the medical device data from the buffer element35a(as necessary) and forward the medical device data to the transceiver32for transmission to the access point40over the WWAN.

Alternatively, in step404, the status module32bmay indicate that the WWAN is not accessible by the transceiver32. For example, if the one relay module30ais located on a basement floor of the building in an area that is substantially shielded with respect to WWAN signals, the WWAN may not be accessible to the one relay module30a. In this event, at step408, the processor34determines whether a second relay module30ais accessible via the WLAN or WPAN. Again, this determination may be made in a variety of manners including by instructing the transceiver31to send a handshake signal transmission directed to a second relay module30aand to listen for a reply, or by retrieving a stored status indicator for the second relay module30a.

If the second relay module30ais accessible, then the processor34instructs the data processing circuit33of the one relay module30ato retrieve the medical device data from the buffer element35a(as necessary) and forward the medical device data to the transceiver31for transmission to the second relay module30aover the WLAN or WPAN at step410. Alternatively, if the second relay module30ais inaccessible in step408, this portion of the process400may preferably be repeated to search for a further relay module30athat is accessible. Alternatively, or in the event that no other relay module30ais available, the processor34of the one relay module30amay preferably issue an alarm notification at step412. Such an alarm notification may, for example, include one or more of local visual and audio alarms as directed by processor34via the input/output circuit36of the one relay module30a, alarm messages directed by the processor34to another accessible WPAN, WLAN or WWAN via one or more of the transceivers31,32, and/or alarm messages generated by the inbound web server41of the access point40ofFIG. 1after a specified time period has been exceeded during which a handshake signal of the relay module30ais due to be received at the inbound web server41.

FIG. 5presents a flow diagram500illustrating another exemplary method of operation500for the architecture according toFIG. 1, relating to the transmission of a message from the access point40to be received by one of the medical devices10. This enables the access point40, for example, to communicate with medical devices in order to download new firmware or software, to respond to error messages initiated by the medical devices (for example, to re-set a device or remove it from service, or to run device diagnostics), and to operate the medical device (for example, to adjust a flow rate on a feeding pump).

At step502of the method500, the message is received at the first one of the relay modules30afrom the access point40via the WWAN. At step504, the one relay module30determines whether the message is intended to reach one of the interface circuits15,17aand/or other relay modules30,30alocated in the facility20. This may be accomplished, for example, by maintaining a list of active interface devices15,17aand modules30,30ain the buffer element35aor in a manner otherwise accessible to the one relay module30a, or coding an identifier of the interface device15,17aor module30,30ato include an identity of the facility20that is stored in the buffer element35aor is otherwise identifiable to the one relay module30.

If the one relay module30adetermines at step506that the interface device15,17aor module30,30ais not located in the facility, the one relay module30may preferably proceed to discard the message at step508, and/or alternatively alert the access point40with a non-delivery message. If the interface device15,17ais located in the facility20, the one relay module30adetermines at step510whether the interface device15,17aor relay module30,30aaccessible to the one relay device30avia the WLAN or WPAN (for example, by consulting a list stored in the buffer element35aor that is otherwise accessible to the one relay module30a, or by instructing the transceiver31to send a handshake transmission directed to the interface device15,17aand to listen for a reply).

If the one relay module30adetermines at step512that the interface device15,17aor relay module30,30ais accessible, then at step514, it transmits the message via network16to that device15,17aor relay module30,30avia the transceiver31. In this case, the message may again be broadcasted to all interface devices15,17aand modules30,30ain communication with the one relay module30a, and each device15,17aor module30,30amay decide to act on or ignore the message (for example, by matching to an associated identifier for a medical device10or patient identification device17, or other identifier in the message). If the one relay module30aalternatively determines at step512that the interface device15,17aor relay module30,301is not accessible, then it proceeds at step516to determine whether a second relay module30,30ais accessible via the WLAN or WPAN (for example, by instructing the transceiver31to send a handshake transmission directed to the second relay module and to listen for a reply). If the second relay module30,30ais available, then the one relay module30forwards the message to the transceiver31for transmission to the second relay module30,30aover the WLAN or WPAN. If the second relay module30,30ais inaccessible, then this portion of the process500may preferably be repeated to search for a third relay module30,30athat is accessible while medical device data remains stored in, for example, buffer element35a. Alternatively, or in the event that no other relay module30,30ais available, the one relay module30may preferably issue an alarm notification at step522, preferably in one of the same manners described above in reference to the method400ofFIG. 4. Once the message is received by an interface device15,17afor an intended medical device10or patient identification device17, the interface device15,17apreferably broadcasts a confirmation message to nearby relay modules30,30afor forwarding to access point40.

FIG. 6presents a flow diagram illustrating an exemplary method600of identifying a patient that is associated with (that is, intends to receive treatment from or provide patient identification information and/or patient medical and/or physiological data to) a medical device10(as depicted, for example, inFIG. 1). At step602, the process may be initiated, for example, by actuating the synchronization switch38kon the control panel38as illustrated inFIG. 3(e) of a relay module30ain proximity to the medical device10. The relay module30aenters an identification signal reception mode, in which it waits for a first predetermined interval (for example, using a time-out algorithm) at step604to receive patient identification data over the facility-oriented wireless network via the interface device17aof a patient identification device17. The relay module30apreferably indicates receipt by presenting an audible or visual signal at the control panel38, or by broadcasting a receipt signal to the patient identification device17over the facility-oriented wireless network.

At step606, after receipt of the patient identification information, the relay module30awaits for a second predetermined interval to receive medical device identification information over the facility-oriented wireless network via the interface circuit15of a medical device10. Once again, the relay module30apreferably indicates receipt of this medical device data by presenting an audible or visual signal at the control panel38, or by broadcasting a receipt signal to medical device10over the facility-oriented wireless network. It should be understood that the order of receipt of the patient identification data and the medical device identification information (which may be respectively transmitted, for example, by a caregiver operating the patient identification device17and the medical device10) may be inverted. In addition, the inventive process600may optionally first require the caregiver to transmit caregiver identification data (for example, via one of the patient identification device17or the medical device10, or via a sensor provided in the relay module30a) which is validated by comparison to a caregiver identification table maintained for example in the memory35bof the relay module30a, or alternatively by forwarding a validation request to the remote monitoring system at the access point40over one or more of the facility-oriented wireless network and WWAN via an associated one of the transceivers31,32.

At step608, upon receipt of each of the patient identification data and the medical device identification data, a verification process is initiated. This process is carried out by the exemplary method700illustrated in the flow diagram ofFIG. 7.

At step702ofFIG. 7, a patient identification directory in the memory35bof the relay module30ais interrogated to determine whether a record is present including the received patient identification data and medical device information data, and if so, whether this record includes a “fresh” time stamp indicating that the record is current (for example, if patient identification is verified on a daily basis, a time stamp during the current day). If the time stamp is current, the record is retrieved from the patient identification directory at step712, and an acknowledgement status identified is extracted from the record at step710.

If the patient identification data and medical device identification data are not present in the patient identification directory, or if the time stamp does not indicate that a record including such data is current, the relay module30aproceeds to form a data packet including the patient identification information and medical device identification and to encrypt this packet (for example, using a suitable conventional encryption algorithm such as secure sockets layer (SSL) data encryption) at step704, and then transmits the encrypted data packet at step706for further validation to the remote monitoring system at the access point40over one or more of the facility-oriented wireless network and WWAN via an associated one of the transceivers31,32. Alternatively, the patient identification information and/or the medical device identification information may be encrypted by one or more of the patient identification information device or the medical device, and steps702,704and712may be omitted.

At step708, the relay module receives a reply packet from the remote monitoring system via one of the transceivers31,32, and decrypts that packet. At step710, the relay module30aextracts the acknowledgement status identifier from the decrypted packet. At step714, the relay module30apreferably adds a record to the patient identification directory in the memory35bthat includes the patient identification information, the medical device identification information, the acknowledgement status identifier and a current time stamp.

Returning toFIG. 6, at step610, the relay module broadcasts the acknowledgement status identifier (preferably together with at least one of the patient identification data or the medical device identification data) via the transceiver31to the medical device10. Upon receipt of the acknowledgement status identifier, the medical device10begins operation and transmits medical device data via an associated interface circuit15over the facility-oriented wireless network for receipt by the wireless network30aat step612. The acknowledgement status identifier may preferably be encoded to instruct the medical device10to operate with predefined operating parameters. Optionally and alternatively, and before beginning operation, the medical device10may transmit a request via the interface circuit15to confirm preset operating parameters and/or request additional information. Once the operating parameters are confirmed and operation of the medical device10begins, the wireless network30amay operate according to the previously-described processes400,500ofFIGS. 4,5.

As illustrated for example inFIG. 2, each rely module30,30ais capable of communicating with a number of medical devices10over a period of time. It is possible that communications with some of the medical devices10are more time-critical with regard to patient safety than others. For example, consider communications with medical devices10including each of a thermometer, a feeding pump and a ventilator. In this case, communications with the ventilator would likely be most time-critical among the three medical devices, while communications with the thermometer might be least critical among the three medical devices.

In accordance with the IEEE 802.15.4 standard, if the network16is a ZIGBEE mesh network then there is little risk that communications from more than one medical device will contend for simultaneous access to the network16. The network16operates with a protocol in which a transmitting device checks for energy on a wireless bus component of the network16. If the bus is in use, the transmitting device waits a preselected amount of time before checking again, and only proceeds to transfer data when the energy level suggests that no other transmission is actively underway on the wireless bus. Nevertheless, for circumstances in which medical device data packets transmitted by the medical devices10arrive at a relay module30,30aat nearly the same time, there may be a need to manage an order of delivery by the relay module30.

For example, consider a data packet from a ventilator indicating disconnection from a comatose patient, with possible fatality. In this case, the ventilator should be assigned priority for transmitting to one or more of remote monitoring devices61,62and63, while data transmissions from thermometer and pump are discontinued until a response to the data packet transmitted by the ventilator is received from one of the remote monitoring devices61,62and63. For example, the ventilator might be assigned a priority of 1, while the feeding pump is assigned a priority of 2 and the thermometer is assigned a priority of 3. The assigned priority is preferably indicated in each data packet transmitted by and to the medical devices, for example, as a “priority nibble.”

With reference toFIG. 3(a), the processor34may be configured to read the priority nibble from each received data packet, and to instruct the data processing circuit33to place the data packet at a logical position in the buffer element35abased upon the priority designation. For example, critical data packets for the ventilator would be positioned for first retrieval and transmission by the relay module30,30a, and other data packets are respectively positioned in order according to their priority.

In addition, under circumstances where urgent commands may need to be transmitted by one of the remote monitoring devices61,62and63anticipated based on an urgent data packet from the medical device (ventilator), the wireless relay module30,30amay in addition discontinue reception of any new medical device information from other medical devices until the urgent commands are relayed and an associated alarm condition has been terminated or released.

The wireless relay module disclosed herein for providing networked communications between a series of medical devices and a remote monitoring device provides a number of distinct advantages in comparison to other monitoring systems. By employing wireless relay networks such as ZIGBEE networks based on the IEEE 802.15.4 standard, for wireless communications between the medical devices10and relay modules30,30ain accordance with one embodiment of the invention, power and size requirements can be minimized so that the interface circuits15can be easily and inexpensively applied to and/or integrated with the medical devices10.

By introducing relay modules30athat are part of the wireless relay networks and are directly able to access off-site monitoring devices via a WWAN, access to and reliance on existing and potentially unreliable LAN facilities at a facility can be avoided. By incorporating relay features into the relay modules30athat relay communications from a first relay module30ato a second relay module30ain the event that WWAN access to the first relay module30ahas been compromised, the present invention improves reliability and enables the use of conventional, low-cost cellular transceivers in the relay modules30afor accessing the WWAN.

It is possible to limit the configuration of cellular transceivers to just the relay modules30ain a facility, instead of modules30and30a. In addition, by providing the relay modules30ain a compact enclosure, the relay modules30aare easily connected to reliable commercial power sources and easily moved when needed to reconfigure the wireless relay networks according to facilities changes. The portability for ambulatory use that is provided by battery back-up is an additional advantage.

It should of course, be understood that while the present invention has been described with respect to disclosed embodiments, numerous variations are possible without departing from the spirit and scope of the present invention as defined in the claims. For example, the present invention may be based on any of a number of current and future WPAN, WLAN and WWAN standards beyond those explicitly described herein. It should also be understood that it is possible to use exclusively relay modules30ain the WLAN or WPAN network16ofFIGS. 1 and 2, with transceivers for communicating with other relay modules as well as over the WWAN.

In addition, respective interface circuits useable with the present invention may include components of and perform the functions of the module30to provide greater flexibility in accordance with the present invention. Further, numerous configurations of components for relay module30aare useable with the present invention beyond the components shown inFIG. 3. For instance, an input-output buffer may be used with respective switches under control of a processor for directing medical device data to transceivers31,32as needed. Moreover, it is intended that the scope of the present invention include all other foreseeable equivalents to the elements and structures as described herein and with reference to the drawing figures. Accordingly, the invention is to be limited only by the scope of the claims and their equivalents.