English:
[0004] The situation, as described above, is constantly faced by many hospitals in both the developed and developing countries. Presently, much of the time of medical staff is occupied not only with dealing with emergencies but also with the routine measurement of blood glucose levels, blood oxygen and carbon dioxide levels, blood pressure, pulse rate, temperature and respiration rates of patients apart from existing duties such as aiding in the cleanliness and medication of the patients concerned.
[0005] Attempts to automate the routine portions of the job of a medical caregiver include providing an automated measurement system of physiological parameters such as blood pressure, respiration rate and temperature by transceiver devices. Such systems are disclosed in US Patents 6,589,170, 6,544,174, 5,997,476, PCT application WO 01/45014 Al, and US Patent application US 2004/0215098 Al.
[0006] US Patent 6,589,170 discloses a patient monitoring system that comprises a controller, a receiving station and a transceiver sensor located within a local area network (LAN) that can monitor a physiological parameter of a patient. The transceiver is attached to the patient and the document further discloses that the transceiver, which maintains multiple links to various receiving stations, utilizes the time division multiple access (TDMA) protocol in order to transmit and receive data from the LAN to which it is linked. Figure 2 of the US patent shows the attachment of one such transceiver. Based on the design of the transceiver, regardless of where it is placed, be it on the front or rear of the torso, it hinders the mobility and comfort of a patient.
[0007] US Patent 6,544,174 discloses a patient monitoring system that comprises a local area network (LAN), a wireless transceiver sensor and control devices to receive and monitor the physiological parameters that are measured by the sensor. The transceiver utilizes the TCP/IP and UDP protocols to transmit and receive data from the control devices via the LAN. The control device is configured to monitor the physiological parameters received from the transceiver against predetermined threshold values, the frequency of the transmissions and the location of the transmissions, which correlates to the location of the patients as well.
[0008] US Patent 5,997,476 discloses a networked system for the interactive communication and remote monitoring of individuals. In this system, the patient is required to provide an input to the remote interface. The remote interface transmits the input of the patient to a server where the responses are analyzed by a script program. The server responds by transmitting messages back to the patient in order to obtain more data or to advise a patient accordingly. The frequent transmissions and "listening" of the receiver of such a device within said system leads to a consumption of a substantial amount of battery power. In order for the system to function effectively, the remote device contained therein usually requires a large power source or require frequent maintenance in order to function for the period required.
[0012] However, there is still a need to provide a cost effective and reliable system capable of measuring, receiving, recording and processing at least one physiological parameter of at least one person remotely or otherwise. There is also a further need to provide a system, wherein said system provides for a physiological parameter-measuring device that is user — friendly, cost effective and has the capability to remotely measure physiological parameters. In addition, the measuring device should also be functionally efficient to prevent the loss of data during transmission while also capable of tracking the location of said patients within a given area.
[0013] The system, devices and method having the features of the respective independent claims solve the above-mentioned problems.
[0020] Typically, for magnetic means, every magnetic activation means may be utilized. Examples of magnetic non-radio frequency activation means may be a magnetic relay switch, a reed switch and a momentary contact switch. In a further embodiment, the system may further include a separate registration unit that is adapted to function in unison with the switching activation device. The registration unit may be a microprocessor capable of registering (or deregistering) the measuring device when the measuring device is in either the first or second switching state respectively.
[0021] In another embodiment, the system may further comprise of at least one receiver unit. The receiver unit may be adapted to receive a data packet that is transmitted periodically by the at least one measuring device.
[0022] In a further embodiment, the system may further comprise at least one control unit. The control unit is adapted to receive data packets from the receiver unit. The control unit may also be adapted to function as a registration unit as well.
[0023] The at least one measuring device has stored therein, on a memory chip, a unique identifier. The unique identifier allows the registration unit to recognize the at least one measuring device during the registration process. Alternatively, in the embodiment wherein the control unit functions at the registration unit, the control unit may recognize the unique identifier during the registration process. The registration unit is adapted to recognize and record an association between the unique identifier of the at least one measuring device and the particulars of a person.
[0024] Typically, components of the system such as the measuring device, registration unit, receiver unit and control unit, for example, are in communication using a radio frequency (RF) wireless local area network (WLAN) that utilizes one or a multitude of protocols such as WiFi, ZigBee, Bluetooth or other proprietary protocols, for example. Alternatively, the components of the system may utilize a wired local area network (LAN) using one or a combination of protocols such as RS-232, RS-485, the Ethernet or a combination of wireless and wired local area network protocols.
[0025] Once the integrated switching mechanism of the measuring device is activated to the first switching status, the RF signal-transmitting device will transmit the unique identifier to the receiver unit. The receiver unit will then relay the unique identifier to the control unit. The control unit will in turn relay the unique identifier to the registration unit for registration into the communication network. The registration unit may then assign the identity of a patient being monitored to the newly registered unique identifier of the measuring device thereby personalizing the said measuring device.
[0026] The data packet transmitted by the measuring device to the receiver unit, or registration unit as in the case of the registration process, comprises the above-mentioned unique identifier of the at least one measuring device, a signal/data field, at least one measured physiological parameter value and optionally, the battery status of the at least one measuring device.
[0028] Subsequently, when in this embodiment the measuring device is removed from the switching activation device, it then enters the "ON" sub-status of the first switching status and continues to transmit except that it now transmits information packets periodically to the control unit. Each information packet, as with the registration packet, still contains the signal/data field. However, the signal/data field of the information packet now only includes data specific to the information transmission mode, and not to the registration mode or de-registration mode. In other words, the information now transmitted to the control unit pertains rather to the person to which the measuring device is attached to and may only relate to only a physiological parameter such as the temperature, heart rate or pulse rate, for example.
[0030] In an alternative embodiment, when the measuring device is first brought into contact with the switching activation device during registration, the measuring device also enters the initialization status of the first switching status. However, in instead of continuous transmission of registration packets (until the contact with the switching activation device is stopped) the measuring device transmits a predetermined number of registration packets, for example, 10, 15 or 20 registration packets. This status is referred to as the initialization sub-status of the measuring device. Each registration packet contains the signal/data field, which contains the relevant data to indicate to the control unit that registration is taking place or is initiated. Also, in this embodiment the control unit in turn will create an association between the measuring device being registered and a profile/person to which said measuring device will be attached to. As soon as the predetermined numbers of registration packets have been transmitted, the measuring device automatically enters the second sub-status of the first switching status, even if it still remains in contact with the switching activation device. In the second sub-status of the first switching status, the measuring device now transmits information packets.
[0034] In yet another embodiment, when the measuring device is in the first switching status, the data packets transmitted to the controller unit include data/signal fields. However, in this embodiment, the data/signal fields may include both registration data as well as the measured physiological data. Accordingly, the first switching status in this embodiment, unlike the first switching status of the previous embodiment, comprises a single sub-status. In the single sub-status, the measuring device, when in contact with the switching activation device, begins to transmit both registration data as well as measured physiological data as well.
[0036] The measuring device may not transmit the battery status along with the various data packets that are transmitted during the respective four sub-statuses. Instead, the battery contained therein may be adapted to perform a fixed number of transmissions. Accordingly, in such an embodiment, the number of transmissions made correlates to the battery status in that said battery status may be derived from the number of transmissions made and the number of transmissions that the measuring device may still make. As an illustrative example, should a battery be adapted to perform ten transmissions and has already performed five of said ten possible transmissions, it may be concluded that the battery is at fifty percent of its original strength.
[0037] In this embodiment of monitoring the battery status, the control unit may be tasked with monitoring the number of transmissions made by each registered measuring device. In this regard, the control unit may perform a comparative operation and determine that the remaining battery power of a measuring device is low. Subsequently a warning may be issued by the system to any administrators instructing them to replace the measuring device or the battery contained therein.
[0038] In order to increase the reliability of the transmission from the at least one measuring device to the receiver unit, the measuring device may utilize an anti-collision algorithm to minimize the occurrence that two measuring devices transmit simultaneously thereby resulting in a collision of data packets at the receiver unit. Examples of the aforementioned anti-collision algorithm that may be used with the present invention are disclosed in United States Patents US 6,629,776 and US 6,589,170 to name only a few. Apart from these known algorithms, the present invention discloses a novel anti-collision algorithm. This anti-collision algorithm utilized by the present invention, provides for each measuring device, a pseudo-randomized time-slot to periodically transmit a data packet. In one exemplary embodiment of this algorithm, the likelihood of a measuring device having a data packet collision occurring in a scenario where 20 measuring devices are within range of a receiver unit is 1.855%. The likelihood of the same measuring device having a data packet suffering a second consecutive collision decreases to 0.0344%. The anti-collision algorithm of the invention is discussed in greater detail below.
[0039] Upon receiving the data packet from the measuring device, the receiver unit appends a time and date of receipt information (henceforth known as time-code) to each data packet that it receives. In order to accomplish an accurate time coding of all data packets sent to the various receiver units, each receiver unit comprises an internal clock. The internal clocks of all the receiver units are synchronized with the internal clock of the control unit. The receiver units are programmed such that when reset, the startup sequence dictates that the reset receiver units will automatically request such synchronization from the control unit. Alternatively, the receiver units may also conduct a synchronization procedure upon receiving such instructions from the control unit. The synchronization process occurs at least every twenty-four hours or as and when deemed necessary.
[0040] In addition to each receiver unit having an internal clock, each receiver unit has stored therein its own unique identifier. When a receiver unit, in addition to the time- code, receives a data packet the receiver unit appends the unique receiver identifier to the data packet prior to forwarding the data packet to the control unit. Such repeated coding allows the control unit to record which receiver unit transmitted a particular data packet and which particular measuring device said data packet originated from. This also allows the control unit to track the position of each measuring device (as each receiver unit is located in a specific area). Should a particular data packet from a particular receiver unit indicate that a patient has a physiological anomaly, using the time-code information, all other data packets that were transmitted by that particular receiver from other measuring devices can be traced. This means that other patients who may have been in the immediate vicinity of the anomalous patient can be identified for closer observation and immediate treatment rendered, if necessary.
[0044] The system may be linked to the Internet thereby allowing health specialists from other health facilities, especially those who are overseas, to monitor and retrieve data should they be authorized to do so.
[0048] In the above-mentioned embodiment where a mechanical switch, such as a pin actuated mechanical switch, is used, the first actuation of the mechanical switch sets the measuring device into the first sub-status of the first switching status. The first sub-status of the first switching status is the initialization state and takes place during registration. Accordingly, as described above for this embodiment, during the initialization status of the first switching status the measuring device transmits registration packets periodically. Each registration packet contains the signal/data field, which contains the relevant data to indicate to the control unit that registration is taking place or is initiated. The control unit in turn will create an association between the measuring device being registered and a profile/person to which said measuring device would be attached to.
[0049] Subsequently, when the measuring device having the pin actuated mechanical switch is removed from the switching activation device, it then enters the "ON" sub-status of the first switching status and continues to transmit except that it now transmits information packets periodically to the control unit. Each information packet, as with the registration packet, contains the signal/data field. However, the signal/data field of the information packet now only includes data specific to the information transmission mode, and not to the registration mode or de-registration mode. In other words, the information now transmitted to the control unit pertains to the person to which the measuring device is attached to and may be relate to a physiological parameter such as the temperature, heart rate or pulse rate, for example.
[0051] Further examples of mechanical activation may be selected from the group consisting of a pressure switch, a contact switch, a slider switch, a rocker switch, a pushbutton switch, and a rotary switch. Each mechanical switch may be adapted to allow for the four sub-statuses of the first and second switching statuses to be attained respectively.
[0052] The measuring device incorporates a radio frequency (RF) signal-transmitting device. The RF signal-transmitting device is adapted to provide for one-way radio frequency communication. However, if necessary, an embodiment that requires the monitoring system to communicate with the patient may utilize a two-way RF communication device. In this case, the RF signal-transmitting device provides a wireless two-way transfer of data and signals between the measuring device and the receiver unit.
[0053] In principle, the measurement unit of the measuring device may be adapted to measure any physiological parameter, such as the body temperature, blood pressure, pulse rate, SpO 2 , blood CO 2 and O 2 levels, electrocardiogram (ECG), blood glucose levels and respiration rates or any combination thereof. It is to be understood that any other appropriate measuring device for measuring a physiological parameter may also be used.
[0054] In one embodiment, each measuring device may further include a unique identifier. The RF signal-transmitting device transmits the unique identifier to a monitoring system in order that the monitoring system may precisely identify the individual measuring devices present within the system and those from which data is being transmitted. Since each measuring device is worn by a patient, the personal particulars of each patient may then be also associated with the unique identifier of their respective measuring devices.
[0059] In addition, the invention is directed to a method and switching activation device using the system as described above. This method comprises:
[0064] After registration, the measuring device proceeds to measure the assigned physiological parameter intermittently. When measuring the temperature of a patient, the measuring device obtains the necessary value and transmits, intermittently, the measured value to the receiver unit in the form of data packets, for example. Along with the measured value, the unique identifier and the battery status of the measuring device are also included in each data packet transmitted to the receiver unit. As mentioned above, the transmission of the data packets is conducted according to the time-slot allocated by the anti-collision algorithm used by the measuring device. The receiver unit receives the data packet and appends the unique receiver identifier to every data packet received. In addition, each receiver unit appends a time-code comprising of the time and date of receipt of a particular data packet. The receiver forwards each received data packet to the control unit for recordation and monitoring.
[0065] The control unit is used to compare the measured value of at least one physiological parameter with a predetermined threshold value. An exemplary method of calculating said predetermined threshold value that can be used here is disclosed in PCT application WO 2005/006970 Al. Through the use of a graphic user interface (GUI) and a suitable multimedia system, the control unit may be able to provide audio and visual alerts and information-on-demand. The audio and visual alerts may be configured to be activated should the measured physiological values deviate by a predetermined percentage or value from the predetermined threshold values obtained from the method disclosed in the above- mentioned PCT application.
[0068] FIG. 2 illustrates the flow chart for the program, called the measuring device control program (MDCP) hereafter, which in one exemplary embodiment controls the operation of the measuring device;
[0069] FIG. 3 illustrates the flow chart for one exemplary program controlling the synchronization of the date/time of the receiver unit with the control unit;
[0070] FIG. 4 illustrates one program that controls the operation of the control unit (CU);
[0072] FIG. 6 illustrates the transmission time line as well as the different transmission times of the measuring devices in one embodiment;
[0073] FIG. 7 illustrates the system configuration of one embodiment indicating the various components and how they are connected to each another;
[0074] FIG. 8 illustrates an embodiment of the measuring device component of the system;
[0075] FIG. 9 illustrates a further embodiment of the measuring device component of the system;
[0076] FIG. 10 illustrates an embodiment of the switching activation device of the system; and
[0077] FIG. 11 illustrates a further embodiment of the switching activation device of the system.
[0080] In the one embodiment, the measuring device 26 of the present invention is placed on the middle region located between the right iliac 14 and the right hypochondriac 20 or between the left iliac 14 and the left hypochondriac 20, preferably along the line 24 or line 8 respectively for optimum results. To ensure that the measuring unit of the of the measuring device 26 is in optimum contact (an acceptable area of contact) with the skin of the patient, two layers of adhesive are used to help negate the slipping effect that may be present due to the perspiration from the skin of a patient. In another preferred embodiment, the measuring device 28 may be wrapped around the cuff of the patient as shown in Figure 1.
[0083] In the event that the switch is open, the MDCP drives the measuring device 26 or 28 into the "ON" mode 40 (second sub-status of the first switching status). Failing which, it loops back to the previous step 36 and the measuring device 26 or 28 continues to send out registration packets at three-second intervals. In the "ON" mode 40 the MDCP calls the anti-collision algorithm (ACA) to generate pseudo-random time intervals Ts. The program drives the measuring device 26 or 28 to transmit information packets (viz. temperature, blood pressure etc.) at these pseudo-random time intervals. The ACA generates each pseudo-random time interval T so that the probability for two or more measuring devices 26 or 28 to transmit packets simultaneously is reduced.
[0084] In the "ON" mode 40, the MDCP will monitor the state of the switch 42 to establish if it has been closed for a period 't' of two seconds. Otherwise, the MDCP loops back to the previous step 40 and continues to drive the measuring device 26 or 28 to transmit the aforementioned information packets. Then the MDCP drives the measuring device 26 or 28 to transmit the data de-registration packets at 3 second intervals and stop the transmission of information packets 44 (first switching sub-status of the second switching status). The de-registration packet comprises the unique identifier of the measuring device, a signal/data field to indicate de-registration, the battery status of the at least one measuring device and at least one measured physiological parameter value.
[0085] From this step 44 the MDCP continues to check the status of the switch 46. As long as the switch remains closed it continues transmitting de-registration packets. The moment it detects that the switch is open, it loops back to the very beginning 30, viz. the step where it is in the "OFF" mode 30 (second switching sub-status of the second switching status). From here, the whole cycle repeats again.
[0086] FIG. 3 illustrates the flow chart for the program controlling the synchronization of the date/time of the receiver unit with the control unit. This program is termed the Synchronization Date/Time Program or (SDTP) 48. Upon initialization (power up of the system), the SDPT 48 drives the receiver unit (RU) to request for synchronization of date/time with the control unit 50. Next, the SDPT 48 checks if the date/time of the RU has been updated after the request was sent 52. Otherwise, the SDPT 48 continues to drive the RU to send the aforementioned synchronization request 50. If the date/time of the RU has been updated, the RU can proceed to receive packets from the measuring devices, date/time stamp these data packets and forward them to the control unit 54. The SDPT 48 also checks if the RU has been re-started 56. If it has, then the SDPT 48 loops back to the first step 50 and send out the request for synchronization as mentioned. The whole process is then repeated.
[0087] FIG. 4 illustrates the control unit program (CUP). The program sends instructions to all RUs, upon initialization (power up of the system), to synchronize their date/time with the control unit (CU) itself 60. Next, the CUP checks and reports on the status of all RU 62. This is done to ensure that all RU are functioning and to ensure that their data/time are all synchronized with the CU. The CUP also checks if the duration t, measured from the time of initialization till the current time, is 24 hours 64. If t is 24 hours, CUP loops back to the first step 60 and retransmit the synchronization instructions to all RUs. If not, CUP monitors and stores data received from the RUs 66.CUP compares the data received from the RUs with the standards and determines the acceptability 66. If data received is not acceptable, CUP sounds an alarm 68. It will continue to assess the acceptability of the data received in comparison to the standards. The CUP will stop the alarm only when the data received is acceptable.
[0088] FIG. 5 shows the flow chart of the Anti-collision algorithm (ACA) 72. Upon initialization (power up) of the measuring device 26 or 28, 'seed' (a global variable) is initialized to the least significant 16 bits of the measuring device ID 74. Note that 'seed' (a global variable) can be "seen" by all programs running within the measuring device 26 or 28 (viz. ACA 72, MDCP 30, function rand 0, etc.). The ACA 72 checks if the measuring device 26 or 28 is in the "ON" mode and if the MDCP 30 has called for it to generate the pseudo-random time interval T 76. If not, the ACA 72 loops back to the previous step 76 and continues this check. If yes, the ACA 72 will call the function 'rand 0'. In the function 'rand ()', the product of the value of 'seed' (global variable) multiplied by 181 is summed with 359 78. The resultant value of this summation is limited to the range 0 to 65535 by ignoring overflow, and is then assigned to 'seed' (global variable) 78. Hence 'seed' (global variable) takes this new value thereafter. Next, the value of most significant or upper 10 bits of the seed (a 16 bit value) is assigned to the local variable 'rand_num' 80. The value of 'rand_num' is then assigned to the function 'rand 0' 80. Note that each time the function 'rand 0' is called by the ACA 72, the global variable 'seed' will be updated (changed).
[0089] Next, the ACA 72 proceeds to assign the value of the function rand 0 to its own local variable also called randjrram 82. The value 1024 is then summed with the value of random_num 84. The value of this summation is assigned to slot_num (local variable of ACA) 84. Finally, the pseudo-random time interval T is calculated as the product of the value of slot_num and the value of the slot_duration (time of each slot). A packet will then be transmitted by the measuring device 26 or 28 at a time equal to T calculated from the current time. Note that the transmission time line is divided into time slots. In the preferred embodiment, the time slots are each 100ms.
[0090] Once a packet has been transmitted, the ACA 72 loops back to the step where it checks if the measuring device is in the "ON" mode and if the MDCP 30 has called for it to generate the pseudo-random time interval T 76. If the measuring device is in the "ON" mode and if the MDCP 30 has called for it to generate the pseudo-random time interval T, the same cycle is repeated to calculate the next pseudo-random time interval T for the transmission of the next packet.
[0094] In one preferred embodiment, the RUs 110 are connected to the control unit 106 via the RS485 serial communicator 108. The measuring devices 114 are wirelessly connected to the RUs 110 The wireless connection only allows for one-way 5 communication, i.e. only from the measuring devices 114 to the RUs 110 as depicted by the direction of the arrows 112.
[0095] The measuring devices 114 comprise a collection of different measuring units, each for measuring different bio-data such as blood pressure, pulse rate, respiration rate, 10 temperature, SpO 2 , ECG, etc. in one preferred embodiment. Each of the measuring devices 114 may comprise sensing devices to sense various types of bio-data, viz. blood pressure, pulse rate, respiration rate, temperature, SpO 2 , ECG, etc. in another preferred embodiment.
[0097] The placement of the measuring device 800 in contact with a magnetic field of a particular strength ensures that the activation or deactivation of the measuring device 800 takes place. Said activation or deactivation occurs via actuation of the mechanical or 30 magnetic relay switch, for example. After the registration process, as described above, is complete, the measuring 800 device resumes normal functioning in that it measures and transmits, periodically, a value of the physiological parameter that it caters to along with any other suitable data such as signal strength, battery strength and unique identification signatures, for example.
[0099] FIG. 9 is an illustration of a further embodiment of the measuring device 900. The views 920 and 940 show that unlike the embodiment of FIG. 8, the present embodiment does not have a protruding portion 805. Instead, the shaded region 905 is flat and coplanar with the surface of the measuring device. The embodiment of FIG. 9 functions in the same manner, as that of FIG. 8 with the exception that the corresponding switching activation device need not have a complementary recess. Instead, as shown in FIG. 10, said switching device may simply have a corresponding flat planar surface on which the measuring device of FIG. 9 may be place for activation.
[00100] In a further embodiment of the measuring device of FIG. 9, a securing means may be incorporated thereto. The securing means may take the form of a socket and plug, for example. In this regard, the plug may be situated on the switching activation device 1000, such as that from FIG. 10, and the socket 955, formed on the measuring device 900 as shown. It should be noted that the location of the socket 955 and the corresponding plug 1055 may be reversed to be situated on the switching activating device and the measuring device respectively.
[00101 ] The embodiment of the switching activation device in FIG. 10 includes a flat activation portion 1050 upon which the measuring device 900 is placed. Accordingly, the switching to a first or second switching status takes place when the measuring device 900 is placed on the activating portion 1050. In an alternative embodiment of the activation portion 1050 of FIG. 10, may include plugs 1055 along the periphery of the activation portion 1050. In this embodiment, the measuring device 900 shown in FIG. 9, for example, may include corresponding sockets 955 to which the said plugs 1055 connect to thereby securing the measuring device 900 to the activation portion 1050. FIG. 1OB illustrates a cross-sectional view 1090 of the switching activation device 1000 and clearly shows the flat planar activation portion 1050.
[00102] The switching activation device 1100, such as one mentioned above is capable of providing a magnetic field capable of activating and deactivating the measuring device 800. FIG. 11 illustrates the switching activation device 1100 having magnetic actuation means. The switching activation device 1100 includes a first tier recess 1150 in which the measuring device 800 sits in during the registration sequence. The switching activation device 1100 also includes a second tier recess 1175 in which another portion of a measuring device 800 sits in. The shape of the measuring device 800 is complementary to the shape of the recess of the switching activation device 1100, like a socket and plug, for example. In addition, the switching device 1100 includes a pair of recesses 1180 located at opposite ends of the recess 1150. The recesses 1180 aid in the placement and removal of the measuring device 800 from the switching activation device 1100.

中文:
[0004]无论是发达国家还是发展中国家的许多医院都在不断地面对上述情况。目前,医务人员的大部分时间除了用来处理现有职责,例如所医治病人地清洁和用药之外,不仅需要处理急诊,还需要对病人的血糖水平、血氧和二氧化碳水平、血压、脉搏率、温度和呼吸率进行例行测量。
[0005]使医务护理者工作中的例行部分自动化的尝试包括:通过收发机装置提供生理参数的自动测量系统,该生理参数例如是血压、呼吸率和温度。这样的系统在美国专利6,589,170、6,544,174、5,997,476、PCT申请WO01/45014A1、和美国专利申请US2004/0215098A1中公开。
[0006]美国专利6,589,170公开了一种病人监视系统,其包括控制器、接收站和设置在局域网(LAN)内部的可监视病人生理参数的收发机传感器。该收发机附着在病人身上,并且该文献进一步公开了:与不同接收站保持多链路的该无线电收发机使用时分多址(TDMA)协议,以便从与其连接的局域网发送和接收数据。该美国专利的附图2显示了一个这样的收发机的配件。根据该收发机的设计,不管将其放置在哪里,即或躯体的前面或背面,它都会防碍病人的活动能力和舒适度。
[0007]美国专利6,544,174公开了一种病人监视系统,其包括局域网(LAN)、无线电收发机传感器和控制装置以接收和监视由该传感器测量的生理参数。该收发机使用TCP/IP和UDP协议经由该局域网从该控制设备发送和接收数据。该控制装置配置用于监视从该收发机接收到的生理参数以防超出预定阈值,还监视传输频率以及也和病人的位置有关的传输位置。
[0008]美国专利5,997,476公开了一种用于个体的交互通信和远程监视的网络系统。在该系统中,病人需要向远程界面提供输入。该远程界面将该病人的输入传送到服务器,在服务器中通过脚本程序分析响应。该服务器通过向病人传回消息以作出响应,以便获得更多数据或据此给病人提出建议。所述系统内部的这种装置的接收器进行频繁的传输和“监听”,导致消耗大量的电池电源。为使得该系统有效地运行,包含在其中的远程设备通常需要大电源或需要频繁的维护,以便在需要的时间段内运行。
[0012]然而,仍然需要提供一种经济合算的并且可靠的系统,该系统能够远程地或以其他方式测量、接收、记录并处理至少一个人的至少一个生理参数。还进一步需要提供一种系统,其中所述系统提供一种用户友好型的、经济合算并能够远程测量生理参数的生理参数测量装置。此外, 该测量装置还应该在功能上有效地在传送期间防止数据丢失,同时也能够在给定区域内跟踪所述病人的位置。
[0013]具有各个独立权利要求所述特征的系统、设备和方法能够解决上述问题。
[0020]通常,对于磁装置,可以使用各种磁激活装置。磁非射频激活装置的例子可以是磁继电器开关、簧片开关和瞬时接触开关。在另外的实施例中,该系统可以进一步包括独立的注册单位,该注册单元适用于和该开关激活装置协同工作。当该测量装置分别处于第一或者第二开关状态,该注册单元可以是能够注册(或注销)该测量装置的微处理器。
[0021]在另一个实施例中,该系统可以进一步包括至少一个接收器单元。 该接收器单元可以适用于接收由该至少一个测量装置周期性传送的数据包。
[0022]在进一步的实施例中,该系统可以进一步包括至少一个控制单元。 该控制单元适用于从该接收器单元接收数据包。该控制单元也可以起到注册单元的作用。
[0023]该至少一个测量装置在其中的存储芯片上存储有唯一标识符。该唯一标识符允许该注册单元在注册过程中识别该至少一个测量装置。可替代地,在该控制单元起该注册单元的作用的实施例中,该控制单元可以在该注册过程中识别该唯一标识符。该注册单元适用于识别和记录该至少一个测量装置的唯一标识符和人的详细信息之间的关联。
[0024]通常,该系统的组件例如测量装置、注册单元、接收器单元和控制单元,例如使用射频(RF)无线局域网(WLAN)进行通信,该射频(RF)无线局域网(WLAN)例如使用一个或多个协议例如WiFi、ZigBee、 Bluetooth或其他的专有协议。替代地,该系统的组件可以利用有线局域网(LAN),该有线局域网使用例如RS-232、RS-485、Ethernet中一个或多个协议的结合,或使用无线和有线局域网协议的结合。
[0025]一旦该测量装置的集成开关机构被激活到第一开关状态,则该射频信号发送装置会传送该唯一标识符至该接收器单元。该接收器单元则会将该唯一标识符转发至该控制单元。该控制单元会依次将该唯一标识符转发至该注册单元以注册到该通信网络。该注册单元可以将受监视病人的身份分配给该测量装置的新注册唯一标识符,从而使所述测量装置个性化。
[0026]由该测量装置传送至该接收器单元或者在注册过程的情况下传送至注册单元的数据包,包括上述至少一个测量装置的唯一标识符、信号/ 数据字段、至少一个测量生理参数值,并且可选地包括该至少一个测量装置的电池状态。
[0028]接着,在该实施例中,当该测量装置从开关激活装置移走时,它进入第一开关状态的“开”子状态并且继续传送,除非它正在周期性地传送信息包至控制单元。每个信息包,和该注册包一样,仍然包含信号/ 数据字段。然而,该信息包的信号/数据字段只包括专用于信息传输模式的数据,而不包括用于注册模式或注销模式的数据。换言之,现在传送至该控制单元的信息与该测量装置被附着在其上的个人更加相关,并且例如可以只涉及仅仅一个生理参数,例如温度、心率或脉搏率。
[0030]在一个替代的实施例中,当测量装置在注册期间第一次接触开关激活装置,则该测量装置也进入第一开关状态的初始化状态。然而,该测量装置不会连续传送注册包(直到停止与开关激活装置的接触),而是传送预定数量的注册包,例如10、15或20个注册包。该状态称为该测量装置的初始化子状态。每个注册包包含信号/数据字段,其包含向控制单元表示注册正在发生或被初始化的有关数据。并且,在这个实施例中,该控制单元会依次创建正被注册的测量装置与所述测量装置将要附着其上的履历/人之间的关联。一旦该预定数量的注册包传送完毕,该测量装置自动地进入第一开关状态的第二子状态,即使它仍然与该开关激活装置保持接触。处于第一开关状态的第二子状态时,此时该测量装置传送信息包。
[0034]在另一个实施例中,当测量装置处于第一开关状态时,传送至控制单元的数据包包括数据/信号字段。然而,在该实施例中,该数据/信号字段可以包括注册数据以及所测量的生理数据。因此,与前述实施例中的第一开关状态不同的是,该实施例中的第一开关状态包括单个子状态。 在该单个子状态中,当该测量装置与该开关激活装置接触时,可开始传送注册数据以及所测量的生理数据。
[0036]该测量装置可以不随分别在四个子状态下所传送的各种数据包一起传送电池状态。相反,包含在其中的电池可以适合于执行固定数量的传送。因此,在这样的实施例中,所完成的传送数量与电池状态输入相关,因为所述电池状态可以由已完成的传送数量和该测量装置还可以完成的传送数量导出。作为一个说明性的例子,如果电池适合于执行十次传送并且已经完成了所述可能的十次传送中的五次,那么可以得出该电池处于其原始电量的百分之五十的结论。
[0037]在监视电池状态的该实施例中,该控制单元可以执行监视由每个已注册测量装置完成的传送数量的任务。在这点上,该控制单元可以执行比较操作并确定测量装置的剩余电池电源低下。随后,一条警告可以由系统发送至任何管理员,以指示他们更换该测量装置或者更换其中所包含的电池。
[0038]为了增加从至少一个测量装置至接收器单元的传送的可靠性,该测量装置可以利用防冲突算法,以使由于两个测量装置同时传送而导致在该接收器单元处发生数据包冲突的概率最小化。例如,美国专利US 6,629,776和US6,589,170中公开了可以应用于本发明的上述防冲突算法的几个例子。除了这些已知算法,本发明还公开了一种新的防冲突算法。 本发明使用的防冲突算法为每个测量装置提供伪随机时隙以周期性地传送数据包。在该算法的一个示范性的实施例中,有20个测量装置在一个接收器单元范围内的情况下,测量装置发生数据包冲突的概率是1.855%。该同一个测量装置具有经受第二次连续冲突的数据包的概率降至0.0344%。本发明的防冲突算法在下面进行更为详细的论述。
[0039]当从测量装置接收到数据包时,该接收器单元将接收信息的时间和日期(以后称为时间编码)附在其接收到的每个数据包上。为了完成发送至各个接收器单元的所有数据包的精确时间编码,每个接收器单元包括内部时钟。所有接收器单元的内时钟与控制单元的内部时钟同步。 该接收器单元被编程以使得当其被复位时,起动序列命令被复位的接收器单元自动地从控制单元请求上述同步。可替代地,该接收器单元还可以在从控制单元接收到这样的指令时,执行一同步程序。所述同步过程至少每二十四小时发生一次,或在认为需要时发生。
[0040]每个接收器单元除了具有内部时钟,每个接收器单元具有存储在其中的自己的唯一标识符。当接收器单元接收到数据包时,除了时间编码之外,该接收器单元在转发该数据包至控制单元之前将唯一接收器标识符附在该数据包上。这样的重复编码使得控制单元记录哪个接收器单元传送了一个特定数据包以及所述数据包来源于哪个特定的测量装置。这还使得控制单元跟踪每个测量装置的位置(当每个接收器单元位于指定的区域时)。如果来自特定接收器单元的特定数据包指示病人具有生理异常,使用时间编码信息,可以追踪到由那个特定的接收器传送的来自其他测量装置的所有其他数据包。这意味着必要时,紧邻该异常病人的其他病人可以被识别以进行更密切的观察,并且如有必要给予即时治疗。
[0044]该系统可以连接到因特网,从而允许来自其他卫生机构的健康专家,尤其是那些来自海外的健康专家,如果他们被授权,就可以监视并提取数据。
[0048]在上述实施例中使用了机械开关,例如销致动机械开关,该机械开关的第一次致动将该测量装置设置为第一开关状态的第一子状态。第一开关状态的第一子状态是初始化状态并且发生在注册期间。因此,如上所述,对于该实施例,在第一开关状态的初始化状态期间,该测量装置周期性地传送注册包。每个注册包包含信号/数据字段,其包含向控制单元表示注册正在发生或被初始化的有关数据。该控制单元会依次创建正被注册的测量装置与所述测量装置将要附在其上的履历/人之间的关联。
[0049]接着,当具有销致动机械开关的该测量装置从开关激活装置移走时,它进入第一开关状态的“开”子状态并且继续向控制单元周期性地继续传送,除非它正在周期性地传送信息包至控制单元。每个信息包, 如同注册包一样,包含信号/数据字段。然而,该信息包的信号/数据字段现在也只包括专用于信息传输模式的数据,而不包括专用于注册模式或注销模式的数据。换言之,现在传送至该控制单元的信息与该测量装置要附着在其上的个人相关,并且例如可以涉及生理参数,例如体温、 心率或脉搏率。
[0051]机械致动的更进一步的例子可以从包括压力开关、接触开关、滑动器开关、摇臂开关、按钮开关和旋钮开关的组中选择。每个机械开关适用于使第一和第二开关状态的四个子状态分别可以达到。
[0052]该测量装置整合射频(RF)信号发送装置。该射频信号发送装置适用于提供单向射频通信。然而,必要时,需要监视系统与病人通信的实施例可以使用双向射频通讯装置。在这种情况下,该射频信号发送装置在测量单元和接收器单元之间提供数据和信号的无线双向传输。
[0053]原则上,该测量装置的测量单元可以适用于测量任何生理参数, 例如体温、血压、脉搏率、SpO2、血CO2和O2水平、心电图(ECG)、 血糖水平和呼吸率或其中的任何组合。可以理解,还可以使用任何其他用于测量生理参数的适当测量装置。
[0054]在一个实施例中,每个测量装置可以进一步包括唯一标识符。该射频信号发送装置传送该唯一标识符至监视系统,以便该监视系统可以准确地识别目前在系统内的单个测量装置,以及正在传送数据的单个测量装置。因为每个测量装置均由病人穿戴,每个病人的个人资料还可以与他们各自的测量装置的唯一标识符关联。
[0059]此外,本发明涉及一种使用如上所述的系统的方法和开关激活装置。该方法包括:
[0064]注册之后,该测量装置间歇地测量所赋予的生理参数。例如,当测量病人的体温时,该测量装置获得必要的数值并间歇地以数据包的形式传送该测量值至接收器单元。与测量值一起,该测量装置的唯一标识符和电池状态也被包括在每个被传输至接收器单元的数据包中。如上所述,根据由该测量装置所使用的防冲突算法分配的时隙进行该数据包的传送。该接收器单元接收该数据包,并将唯一接收器标识符附在每个所接收的数据包上。此外,每个接收器单元将包括接收信息的时间和日期的时间编码附在特定的数据包上。该接收器转发每个所接收的数据包至控制单元以用于记录和监视。
[0065]该控制单元用来比较至少一个生理参数的测量值与预定阈值。一个在这里可以使用的示范性的计算所述预定阈值的方法在PCT申请WO2005/006970A1中公开。通过使用图形用户界面(GUI)和合适的多媒体系统,该控制单元可能提供声音和视觉警报以及需求信息。该声音和视觉警报可以配置为:当该测量的生理值偏离预定阈值预定的百分比或数值时就被激活,所述预定阈值由上述提到的PCT申请公开的方法获得。
[0068]图2示出了程序的流程图,该程序此后称为测量装置控制程序(MDCP),在一个示范性的实施例中该程序用于控制该测量装置的操作;
[0069]图3示出了作为一个示范性程序的流程图,该程序用于控制接收器单元与控制单元的日期/时间的同步;
[0070]图4示出了一个用于对控制单元(CU)的操作进行控制的程序;
[0072]图6示出了在一个实施例中的测量装置的传输时间线以及不同的传输时间;
[0073]图7示出了一个实施例的系统配置,其表示了各种组件以及各种组件如何彼此相连;
[0074]图8示出了该系统的测量装置组件的一个实施例;
[0075]图9示出了该系统的测量装置组件的又一个实施例;
[0076]图10示出了该系统的开关激活装置的一个实施例;以及
[0077]图11示出了该系统的开关激活装置的又一个实施例;
[0080]在一个实施例中,本发明的测量装置26放置在位于右髂骨部14 和右下腹部20之间或左髂骨部14和左下腹部20之间的中间区域,最好是分别沿着线24或线8放置以获得最佳效果。为确保该测量装置26的测量单元与病人的皮肤处于最佳接触(可接受的接触面积),使用两层粘合剂以帮助免除由于病人的皮肤排汗而出现的打滑影响。如图1所示, 在另一个优选实施例中,测量装置28可以缠绕在病人的袖口周围。
[0083]如果开关打开,该MDCP驱动测量装置26或28进入“开”模式40(第一开关状态的第二子状态)。如果开关没有打开,则返回至前面的步骤36,并且测量装置26或28继续以三秒的时间间隔发送注册包。 在“开”模式40,该MDCP调用防冲突算法(ACA)来产生伪随机时间间隔Ts。所述程序驱动测量装置26或28以该伪随机时间间隔传送信息包(即温度、血压等等)。该ACA产生每个伪随机时间间隔T以使得两个或更多测量装置26或28同时传送数据包的概率降低。
[0084]在“开”模式40,该MDCP会监视开关的状态(步骤42)以确定它是否已经关闭了两秒的时间段′t′。如果否,该MDCP返回至前面的步骤40并继续驱动测量装置26或28传送上述信息包。然后该MDCP 驱动测量装置26或28以3秒的时间间隔传送数据注销包,并停止传送信息包(步骤44)(第二开关状态的第一开关子状态)。该注销包包括测量装置的唯一标识符、用以表示注销的信号/数据字段、至少一个测量装置的电池状态和至少一个测得生理参数值。
[0085]从该步骤44,该MDCP继续检查开关46的状态。只要开关保持关闭,它就持续传送注销包。一旦它检测到开关打开,则返回到最开始处30,即它处于“关”模式30(第二开关状态的第二开关子状态)的步骤。由此,整个循环再次重复。
[0086]图3示出了程序的流程图,该程序用于控制接收器单元与控制单元的日期/时间的同步。该程序称为日期/时间同步程序或(SDTP)48。 一旦初始化(系统加电),SDPT48驱动接收器单元(RU)请求与控制单元50的日期/时间同步。接着,在所述请求发送后,SDPT48检查该RU的日期/时间是否已经更新(步骤52)。若否,SDPT48继续驱动该RU发送上述同步请求50。如果该RU的日期/时间已经更新,该RU可以继续从测量装置接收包,在这些数据包中加入日期/时间戳并将它们转发至控制单元(步骤54)。SDPT48还检查该RU是否已经重启(步骤56)。如果已经重启,那么SDPT48返回至第一步50并发送上面提到的同步请求。然后重复整个过程。
[0087]图4示出了控制单元程序(CUP)。一旦初始化(系统加电), 该程序发送指令至所有接收器单元RU以使得它们的日期/时间与控制单元(CU)本身同步(步骤60)。接着,该CUP检查并报告所有接收器单元的状态(步骤62)。这样做以确保所有接收器单元正在工作,并且确保它们的数据/时间全部与该控制单元CU同步。该CUP还检查从初始化的时间算起到当前时间所测得的持续时间t是否为24小时(步骤64)。 如果t是24小时,CUP返回至第一步60并重新传输同步指令至所有接收器单元。如果不是,CUP监视并储存从接收器单元RU接收的数据(步骤66)。CUP将接收自接收器单元的数据与标准进行比较,并确定可接受性(步骤66)。如果所接收到的数据不可接受,CUP发出声音警报(步骤68)。它会继续与标准进行比较并评估所接收数据的可接受性。只有当所接收的数据可接受,该CUP才会停止警报。
[0088]图5示出了防冲突算法(ACA)的流程图72。一旦测量装置26 或28被初始化(加电),′seed′(全局变量)被初始化为测量装置ID的最低有效16位(步骤74)。注意′seed′(全局变量)可以被所有在测量装置26或28内部运行的程序“看到”(即ACA72、MDCP30、rand() 函数等等)。ACA72检查测量装置26或28是否处于“开”模式,并且检查MDCP30是否已经调用它以产生伪随机时间间隔T(步骤76)。 如果否,ACA72返回至前面的步骤76并继续进行该检查。如果是,ACA 72将调用“rand()”函数。在‘rand()’函数中,‘seed’(全局变量) 的值乘以181的乘积与359相加(步骤78)。通过忽略溢出,该加法的结果数值限定于范围0至65535,然后赋值给′seed′(全局变量)(步骤78)。于是,′seed′(全局变量)在此之后取得了新的数值。接着,seed (16位数值)的最高有效位或高10位的数值赋值给局部变量′rand_num′ (步骤80)。然后′rand_num′的数值赋值给函数‘rand()’(步骤80)。 注意:函数′rand()′每次被ACA调用(步骤72)时,该全局变量′seed′将被更新(改变)。
[0089]接着,ACA72继续将函数rand()的数值赋值给它自身的局部变量,也称为rand_num(步骤82)。数值1024然后与该值rand_num相加(步骤84)。求和的数值被赋值给slot_num(ACA的局部变量)(步骤84)。最终,数值slot_num和数值slot_duration(每个时隙的时间) 的乘积作为伪随机时间间隔T。然后,在从当前时间算起等于T的时刻, 测量装置26或28会发送数据包。注意传送时间线被分成时隙。在最优实施例中,该时隙每个是100ms。
[0090]一旦传送了一个数据包,ACA72返回至步骤76,在该步骤检查测量装置26或28是否处于“开”模式,并且检查MDCP30是否调用ACA72产生伪随机时间间隔T。如果测量装置处于“开”模式,并且如果MDCP30已经调用ACA72产生了伪随机时间间隔T,则重复相同的循环以计算用于传输下一个数据包的下一个伪随机时间间隔T。
[0094]在一个优选实施例中,接受单元110通过RS485串行通讯线108 与控制单元106连接。测量装置114无线地连接到接收器单元110。无线连接只允许单向通信,即如箭头112所示方向,只允许从测量装置114 到接收器单元110的通信。
[0095]在一个优选实施例中,测量装置114包含许多不同的测量单元, 每个测量单元用于测量不同的生理数据,例如血压、脉搏率、呼吸率、 温度、SpO2、ECG等等。在另一个优选实施例中,每个测量装置114 可以包含传感装置以感测多种类型的生理数据,即血压、脉搏率、呼吸率、温度、SpO2、ECG等等。
[0097]测量装置800与特定强度的磁场接触的位置确保测量装置800的激活或反激活发生。例如,所述激活或反激活通过机械或磁继电器开关的致动发生。如上所述的注册过程完成之后,测量装置800重新开始常规工作,即周期性地测量和传送生理参数的数值,其适合于与任何其他合适数据,例如信号强度、电池强度和唯一标识符签名一起测量和传送。
[0099]图9是测量装置900的又一实施例的图示。不同于图8的实施例, 视图920和940表示本实施例不具有凸出部分805。相反,阴影区域905 是平坦的并且与测量装置的表面共面。图9的实施例除了相应的开关激活装置不必具有互补的凹陷以外,其与图8以同样方式工作相反,如图10所示,所述开关装置可以简单地具有相应的平坦平面,图9的测量装置可以放置在其上以实现激活。
[00100]在图9的测量装置的又一实施例中,可以再整合一个紧固装置。 该紧固装置例如可以采取插座与插头的形式。在这方面,如图10中的样子,该插头可以位于开关激活装置1000上,并且插座955如图所示形成在测量装置900上。应当注意到,插座955和对应的插头1055的位置可以反过来分别位于开关触发装置和测量装置上。
[00101]图10中开关激活装置的实施例包括平坦的激活部分1050,其上放置有测量装置900。因此,当测量装置900放置在激活部分1050上时, 进入第一或第二开关状态的切换就会发生。在图10的激活部分1050的替代实施例中,可以包括沿激活部分1050外围的插头1055。在该实施例中,图9所示的测量装置900例如可以包括与所述插头1055连接的对应插座955,从而将测量装置900固定至激活部分1050。图10B示出了开关激活装置1000的剖视图1090并清楚地显示了平坦的平面激活部分1050。
[00102]开关激活装置1100,例如上面所提到的,可以提供能够激活和反激活测量装置800的磁场。图11示出了具有磁致动装置的开关激活装置1100。开关激活装置1100包括第一级凹陷1150,测量装置800在注册序列期间位于其中。开关激活装置1100还包括第二级凹陷1175,测量装置800的另一部分位于其中。测量装置800的形状与开关激活装置1100 的凹陷的形状互补,就比如是插座与插头。此外,开关激活装置1100包括一对位于凹陷1150的相对端的凹陷1180。凹陷1180有助于从开关激活装置1100上放置和移除测量装置800。