Patent Application
20060030891
The present invention is related to communication systems for use with a medical device and, more particularly, to remote wireless communication systems for medical devices using a two-way communication channel.
In general, medical device reliability is an essential function for any party relying on the availability and proper function of the medical device. Some medical devices, such as conventional, defibrillators, are typically operated by trained personnel and have been generally expensive to purchase and maintain. Because of the relative expense of these devices and the skill/experience level of the trained personnel operating these devices, such medical devices generally include a variety of diagnostic tools to ensure proper function of the medical device. For example, the medical device may include self-test diagnostic functions that detect and indicate when the device is not properly functioning. In addition, technicians may manually check the medical devices by verifying the device's diagnostics and/or conducting additional maintenance tests on a regular basis. While manual monitoring of the medical devices by a skilled technician allows for the verification of medical device functionality, such an embodiment is typically limited to situations in which a number of medical devices are located in a centralized location, such as a hospital. Accordingly, such an embodiment is generally unavailable, or prohibitively expensive, for situations in which only a small number of medical devices are maintained at one location, or where a number of medical devices are maintained in separate locations.
In yet other embodiments, a remote monitoring service can initiate medical device self-tests and software reconfigurations within the medical device. These conventional remote monitoring systems tend to use either wired connections (e.g., LAN or telephone service) or wireless systems such as cellular telephone or specialized proprietary RF systems to communicate with the medical device and initiate testing.
The conventional remote monitoring service 13 is generally configured to obtain status information from the medical device 11. However, the remote monitoring service 13 is typically limited to implementing specific functions dependent on the use state of the medical device 11. For example, when the medical device 11 is powered, but not in operation, the medical device can provide self-test, calibration, expiration or maintenance information to the remote monitoring system. When the medical device 11 is in operation, the remote monitoring service 13 can send control information or the medical device 11 can provide patient diagnostic information to the remote monitoring system 13.
In the above-described system, the remote monitoring system relies on use of more advanced medical device diagnostic tests to determine the device status. Accordingly, these remote monitoring systems require more advanced, and therefore more costly, medical devices having the advanced diagnostic features. Moreover, current conventional remote monitoring systems are limited to providing medical device configuration changes, and are not able to send actual software updates to the medical device.
Thus, there is a need for a system and device for remote wireless communication with a medical device to obtain a status assessment and to provide software updates.
A medical device is configured to support two-way communication to a remote monitoring system to monitor and manage medical device parameter status and software. A two-way communication module is incorporated into the medical device. A remote monitoring service is configured to regularly communicate with the medical device to initiate status assessments of medical device parameters and to perform software updates. The medical device then sends a return message to the remote monitoring service using the two-way communication network. The return message can include the requested information, parameter values, or information about the software update. This system can be advantageously used to efficiently monitor a large number of portable or mobile medical devices in a manner that is transparent to the users of the medical devices.
In accordance with an aspect of the present invention, a communication system is provided including a medical device having a communication module, a two-way communication network and a remote monitoring service. The remote monitoring service is configured to send a communication to the medical device using the two-way communication network, the communication including an instruction for the medical device to perform a status assessment of at least one medical device parameter when the medical device is not in use. Additionally, in response to receiving the communication, the medical device is configured to obtain the requested information and send a return communication back to the remote monitoring service using the two-way communication network, the return communication including the requested information. In another embodiment of the invention, the communication includes software update information and the medical device is configured to update the software stored in the medical device in response to receiving the software update information.
In accordance with another aspect of the present invention, a method for a remote monitoring service to communicate with a medical device using a two-way communication network is provided. In accordance with the method, the remote monitoring service initiates a communication to the medical device using the two-way communication network, the communication including an instruction by the remote monitoring service for the medical device to perform a status assessment of at least one medical device parameter when the medical device is not in use. The medical device receives the communication and performs the status assessment of the at least one medical device parameter in response to receiving the communication. The medical device sends a return communication to the remote monitoring service using the two-way communication network, the message including the requested status assessment. In another embodiment of the present invention, the communication includes software update information to update software stored in the medical device and, upon receiving the communication, the medical device performs a software update with the software update information.
In accordance with yet another aspect of the present invention, a defibrillator is provided having a power source, a charging circuit coupled to the power source, an energy storage device coupled to the charging circuit, an output circuit coupled to the energy storage device, a pair of electrodes coupled to the output circuit, a two-way communication module, and a controller having a memory. The controller is coupled to the two-way communication module, the charging circuit and the output circuit. The controller is configured to selectively cause the charging circuit to transfer energy from the power source to the energy storage device and to cause the output circuit to transfer energy from the energy storage device to the electrodes. Additionally, the controller is further configured to operate the two-way communication module to (i) receive a communication from a remote monitoring service via a two-way communication network, the communication including an instruction for the medical device to perform a status assessment of at least one medical device parameter when the medical device is not in use, and (ii) send a communication to the remote monitoring service via the two-way communication network, the communication including the requested information. In another embodiment of the present invention, the communication includes software update information to update software stored in the controller memory and the controller is further configured to perform the software update with the software update information.
In still a further aspect of the present invention, a defibrillator is provided having a power source, a charging circuit coupled to the power source, an energy storage device coupled to the charging circuit, an output circuit coupled to the energy storage device, a pair of electrodes coupled to the output circuit, and a two-way communication module. The defibrillator also includes defibrillator control means for selectively causing the charging circuit to transfer energy from the power source to the energy storage device and to cause the output circuit to transfer energy from the energy storage device to the electrodes. Additionally, the defibrillator includes communication module control means, coupled to the two-way communication module, for receiving and processing a communication from a remote monitoring service via a two-way communication network, the communication including an instruction for the defibrillator to perform a status assessment of at least one defibrillator parameter when the defibrillator is not in use, and for sending a communication to the remote monitoring service via the two-way communication network, the communication including the requested information. In another embodiment of the present application, the communication includes software update information and the defibrillator control means further include means for updating defibrillator software with the software update information.
In still a further aspect of the present invention, a communication device for use in conjunction with a medical device, a two-way communication network and a remote monitoring service is provided. The communication device includes a controller and a two-way communication circuit coupled to the controller. In response to a communication from the remote monitoring service using the two-way communication network, the communication including an instruction for the medical device to obtain a status assessment of at least one medical device parameter when the medical device is not in use, the communication device is configured to obtain the requested information from the medical device and send a return communication back to the remote monitoring service using the two-way communication network, the return communication including the requested information. In another embodiment of the present invention, the communication includes software update information and the communication device is configured to instruct the medical device to perform a software update.
In yet another aspect of the present invention, a communication system including a medical device having a two-way communication module, a communication network and a remote monitoring service is provided. The remote monitoring service is configured to send a communication to the medical device via the communication network using a first communication medium, the communication including a request for information from the medical device. Additionally, in response to receiving a communication, the medical device is configured to obtain the requested information and send a return communication to the remote monitoring service via the communication network utilizing a second communication medium. The first and second communication media are different.
The foregoing aspects and many of the attendant advantages of this invention will become more readily appreciated by reference to the following detailed description, when taken in conjunction with the accompanying drawings listed below.
Although only one medical device 21 is shown in
As illustrated in
The remote monitoring service 24 initiates the communication by sending a request to the two-way communication network 23 with the desired medical device 21 and data. In general, any wired or wireless data transmission network may be used to initiate the communication. For example, in an illustrative embodiment of the present invention, the monitoring service 24 initiates this communication by calling a “pager” number previously assigned to the medical device 21, using a standard telephone line and modem connection. In another illustrative embodiment of the present invention, the monitoring service 24 initiates this communication by specifying an IP address previously assigned to the medical device 21, or group of medical devices.
In an actual embodiment of the present invention, the remote monitoring service 24 encodes instructions to be transferred by the communication network 23. The encoding of the instructions may include causing medical device instructions to conform to a specific format required by the medical device and/or providing data encryption to the instructions. Further, error correction techniques are often used to ensure correct reception of the encoded instructions in the presence of impairments in the transmission channel. The two-way communication network 23 includes a switch (not shown) that accepts the communication from the remote monitoring service 24 and generates the desired instruction in accordance with the communication medium/method utilized by the particular medical device 21.
At block 33, the medical device 21 receives the communication via the communication module 22 and then extracts the instructions from the communication. The communication module 22 may be configured to send an acknowledgment communication back to the two-way communication network 23 to confirm receipt of the communication. At block 35, the medical device 21 performs the extracted instructions. For example, the medical device 21 may perform a status assessment of a predetermined number of medical device parameters when the device is not in use, or it may perform a status assessment of one or more medical device parameters specified by the remote monitoring service 24 in the communication.
At block 37, the medical device 21 transmits a communication back to the remote monitoring service 24 through the two-way communication network 23. For example, in accordance with communication network 23 utilizing a two-way paging protocol, a “return page” is transmitted in a return channel that is different from the channel (i.e., frequency band) used to transmit the page initiated by the remote paging service 24 in block 31. This type of system allows the medical device 21 to initiate transmission of the return communication without having to wait to be polled by the two-way communication network 23.
In an actual embodiment of the present invention, the return communication contains self-test results, device parameter data, or condition data, depending on the nature of the instructions sent by the remote monitoring service 24. The return communication from the medical device 21 can be immediately provided by the two-way communication network 23 to the remote monitoring service 24 via the same data transmission network that the remote monitoring service 24 used to initiate the communication. For example, two-way communication network 23 may maintain an open wireless communication channel to obtain the return communication from the medical device 21. Alternatively, the return communication may be stored locally by the medical device 21 for later transmission or may be stored within the two-way communication network 23 in a “mail box” for later retrieval by the remote monitoring service 24.
At block 39, the remote monitoring service 24 extracts the information from the return communication. This information can then be displayed for analysis by a technician at the remote monitoring service 24. Alternatively, the remote monitoring service 24 may be configured with a computer programmed to analyze the information. The remote monitoring service 24 can then alert a technician or even the customer when analysis of the information indicates a problem. Additionally, the remote monitoring service 24 may initiate a request for a replacement medical device 21 upon detection of any abnormal status assessment.
One skilled in the relevant art will appreciate that the present invention can include a remote communication system for medical devices in which several medical devices are monitored by the remote monitoring service 24 using the two-way communication network 23. The remote monitoring service 24 would be configured to “poll” each medical device at given intervals, such as at least once a day, depending on the number of medical devices and the capacity of the two-way communication network 23.
In addition, the controller 40 includes a microprocessor (not shown) such as, for example, a model MC68332 available from Motorola, along with a memory 46. Preferably, the memory 46 includes random access memory such as a DRAM (dynamic random access memory) or SRAM (static random access memory), and non-volatile memory such as an EEPROM (electrically erasable programmable read only memory). The EEPROM can be used to store software programs executed by the processor (not shown). In addition, the EEPROM allows the stored software programs to be remotely updated. The power source 41 is implemented with a battery, such as a LP500 battery available from Medtronic Physio-Control Manufacturing Corp., Redmond, Wash. The energy storage device 42 is implemented with a capacitor with a capacitance of about 190-200 μF. The output circuit 43 is implemented in an H-bridge configuration, which facilitates generating biphasic output pulses. For example, the output circuit 43 can be implemented as disclosed in U.S. patent application Ser. No. 08/811,833 filed Mar. 5, 1997, entitled “H-Bridge Circuit For Generating A High-Energy Biphasic Waveform In An External Defibrillator” by J. L. Sullivan et al. In one embodiment, the controller 40, the power source 41, the energy storage device 42, the output circuit 43 and the electrodes 44 and 45 are the same as used in a LP500 AED available from Medtronic Physio-Control Manufacturing Corp. That is, the hardware aspect of medical device 21 is basically equivalent to a LP500 AED with the addition of the two-way pager module 22, along with suitable software programming stored in the memory 46.
In an illustrative embodiment of the present invention, the control unit 52 is also connected to the user interface 53. This feature can be used to display the processed return communications from a medical device 21 so that a user (not shown) can view the information contained in the received return communication. The user can then analyze the displayed information and take appropriate action. For example, the return communication may contain the results of a status assessment initiated by the remote monitoring service 24. Accordingly, the user interface 53 displays values corresponding to the medical device parameters assessed and the user can then contact the customer (or the party responsible for the medical device 21) to perform maintenance, such as taking the medical device 21 to a repair facility.
The user may also use the user interface 53 to initiate communications to the medical device 21. For example, this feature may be used to send a medical device software update or medical device reconfiguration information to the medical device 21. One skilled in the relevant art will appreciate that a medical device 21 includes software, or other logical controls, that controls the various medical device hardware components. Moreover, to allow the medical device 21 to incorporate multiple functions or to adjust the function of the medical device, some medical devices also include medical device configuration information, or device protocol information, that allows one or more parameters modifications within the scope of the underlying medical device software. For example, defibrillator software generally controls the hardware components utilized to produce a therapy signal, while the defibrillator configuration data can adjust the parameters of the hardware components to vary the function of the therapy signal. Other configuration information can include communication protocols or display protocols that do not affect the underlying medical device software. To allow flexibility in the function of the medical device, the present invention allows the medical device configurations to be changed, or modified, without having to modify the underlying medical device software. Accordingly, the remote monitoring service 24 implements medical device configuration changes by transmitting configuration information to the medical device 21.
The present invention further allows the designation, through the user interface 53, of medical device software update data to be transmitted to the medical device. Upon obtaining the medical device software update, the previous software may be discarded, saved or merely modified. Accordingly, if the medical device 21 obtains configuration information from the remote monitoring service, the medical device 21 implements the configuration change and sends a return communication via the communication network on the success of the configuration change. Similarly, if the medical device obtains software update information, the medical device implements the software update and sends a return communication via the communication network on the success of the software update.
One skilled in the relevant art will appreciate that the user interface 53 may utilize any one of a variety of display techniques, including, but not limited to graphical user interfaces, textual displays and/or animation. Moreover, a communication from the remote monitoring service 24 may include a combination of configuration and software update information.
In one embodiment of the present invention, if the battery voltage drops below a predetermined threshold level, the AED will automatically initiate a communication via the two-way communication network 23 to the remote monitoring service 24. In another embodiment of the present invention illustrating a status assessment, the AED may initiate a communication to the remote monitoring service 24 to report values for various medical device parameters, such as the battery voltage, to provide a status assessment. In this embodiment, the status assessment communication may be initiated if the medical device 21 detects a change in the parameter value or if a sufficient amount of time has elapsed since the last report of the parameter value.
In accordance with the present invention, some medical devices may include an on-board controller and clock system such that the controller can be programmed to periodically initiate various medical device actions such as self-tests, status assessments, and the like. Alternatively, the medical device 21 may initiate a communication with the remote monitoring service 24 upon being activated by a user or after being used. For example, the medical device 21 may be programmed to initiate communications indicating when the medical device 21 is used, if the medical device 21 fails in an attempted use, or to communicate the status of the device after it has been utilized.
At block 63, the medical device 21 initiates a communication through two-way communication network 23 to provide the medical device information to the remote monitoring service 24. Block 63 is performed in essentially the same manner as block 37 (
In one embodiment, the controller 73 is the same as the controller 40 (
In an alternative embodiment, the two-way communication network 23 may also support direct data network email communication requests. This alternative embodiment is similar to the embodiment of
The communication device 103 includes a communication module 22 as described above in conjunction with
The independent subsystem 113 can be an independent battery similar to that disclosed in U.S. patent application entitled “Smart Battery With Maintenance And Testing Functions, Communications, And Display”, Ser. No. 09/237,193 filed on Jan. 26, 1999, which is assigned to the same assignee as the present invention, except that the independent subsystem 113 includes communication module 22. The independent subsystem 113 includes a controller 115 that is similar to the controller 73 described above in conjunction with
The embodiments of the remote wireless communication system described above are illustrative of the principles of the present invention and are not intended to limit the invention to the particular embodiments described. For example, in light of the present disclosure, those skilled in the art can adapt the two-way communication system to medical devices other than AEDs without undue experimentation. In addition, those skilled in the art can adapt the two-way communication system to use other wired or wireless public data network interfaces or wireless telephone interfaces in other embodiments. Accordingly, while the preferred embodiment of the invention has been illustrated and described, it will be appreciated that various changes can be made therein without departing from the spirit and scope of the invention.
This is a continuation-in-part of U.S. patent application Ser. No. 09/311,905, filed May 14, 1999. U.S. patent application Ser. No. 09/311,905 is specifically incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 09898754 | Jul 2001 | US |
| Child | 11247515 | Oct 2005 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 09311905 | May 1999 | US |
| Child | 09898754 | Jul 2001 | US |
