Abstract:
A wireless mobile device is provided, typically in the form of a handset that is cable of providing voice and data communication using a wide-area wireless carrier system. The wireless handset has an associated bio-metric sensor, which may be integrally formed with the handset or spaced apart and connected with a wired or wireless connection. A patient uses bio-metric sensor to locally collect data, and then transmit that data to a medical server using the wireless handset. In some cases, the wireless handset may also process the data to transmit result or summary information. In other cases, the wireless handset may process the data to perform a local operation, such as signaling an alarm or displaying results to the patient, or to make an adjustment in the bio-metric sensor or other local medical device. In some cases the wireless handset may also receive commands from the medical server, and make an adaptation to the bio-metric sensor or other medical device, such as a medication pump.

Description:
BACKGROUND 
       [0001]    The field of the present invention is devices and processes for remote collection of bio-metric data using wireless mobile devices, and in some cases, the remote control of the wireless mobile device or a bio-metric sensor. 
         [0002]    The medical device industry has advanced to produce smaller and more effective biometric sensors. These sensors are used by a medical provider, such as a doctor or nurse, to collect important biological data regarding a patient. This data may include, for example, ECG, EKG, brain wave, temperature, pulse rate, hydration, blood chemistry, or glucose levels. In some cases, the provider is able to review the collected data and make an immediate therapeutic diagnosis, such as the case in finding an elevated temperature. In other cases, it is only by collecting data over an extended period of time that important medical results can be evaluated. In these cased, the medical provider may have to make several trips to the patient, or the patient will have to make several trips to the provider&#39;s office, before a meaningful result may be obtained. 
         [0003]    In other cases, patient data is only able to be monitored after an important event has occurred, for example, a mild heart attack. In these cases, the most critical data is never collected as the patient is not in their provider&#39;s office when the attack occurs. 
         [0004]    In one of the most challenge aspects of new drug development, a drug company typically pays for and orchestrates one or more human studies regarding safety and efficacy. These studies are time consuming and expensive, and rely on the voluntary participation of human subjects. These subjects must take their dosages according to predefined guidelines, and submit themselves for continual evaluation at a provider&#39;s office. Since the provider has only limited interaction with each subject, there is a substantial risk that the subject will forget of fail to follow the dosing regimen, will fail to participate in required follow-up and testing, or will have a negative reaction that is not detected in the short evaluation visit. 
         [0005]    Accordingly, there is a need for better collection and use of bio-medical data. 
       SUMMARY 
       [0006]    Briefly, the present invention provides a wireless mobile device, typically in the form of a handset that is cable of providing voice and data communication using a wide-area wireless carrier system. The wireless handset has an associated bio-metric sensor, which may be integrally formed with the handset or spaced apart and connected with a wired or wireless connection. A patient uses bio-metric sensor to locally collect data, and then transmit that data to a medical server using the wireless handset. In some cases, the wireless handset may also process the data to transmit result or summary information. In other cases, the wireless handset may process the data to perform a local operation, such as signaling an alarm or displaying results to the patient, or to make an adjustment in the bio-metric sensor or other local medical device. In some cases the wireless handset may also receive commands from the medical server, and make an adaptation to the bio-metric sensor or other medical device, such as a medication pump. 
         [0007]    In one example, a patient uses a bio-metric sensor to collect glucose blood-chemistry data from time to time. The glucose sensor may be integral to a mobile wireless handset, or may connect using a wire or wireless communication. The mobile wireless handset may locally process the glucose level information, and present information or instructions to the patient. The wireless handset may also communicate the raw or processed data to medical server over a wireless communication channel, such as CDMA, GPRS, or UMTS. With greater computational and storage capability, the medical server may provide additional dosing or instructions to the patient. These messages may be delivered to the patient by voice or through a data message. In other cases, the medical server may send the data, or in a more critical case, an alert, to a medical provider or to an emergency responder. In some cases, the patient may have a local device for administering insulin or other medication, which may be activated or adapted from a command sent from the wireless mobile handset. This command may be locally generated responsive to a timer or to collected data, or may be a command received from a medical provider to from a medical server. 
         [0008]    Advantageously, the disclosed patient handset enables high quality medical care to be more efficiently provided. For example, a patient is able to collect bio-metric data at almost any location, and at any time, allowing for more frequent and consistent data collection, with minimal interruption to the patient&#39;s schedule. Medical providers are able to more closely monitor patient conditions and progress, and communicate with those patients using voice or data channels. For example, a doctor may talk to a patient while viewing data results in near-real time, even though both the doctor and the patient are hundreds of miles apart. Due to the ubiquitous nature of mobile handsets, such patient handsets may be readily deployed, and used in almost every geographic location. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]    The invention can be better understood with reference to the following figures. The components within the figures are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the invention. Moreover, in the figures, like reference numerals designate corresponding parts throughout the different views. It will also be understood that certain components and details may not appear in the figures to assist in more clearly describing the invention. 
           [0010]      FIG. 1  is a simplified block diagram of a system for remote bio-medical data collection and device control in accordance with the present invention; 
           [0011]      FIG. 2  is a diagram of a patient handset constructed for use in a bio-medical data collection system in accordance with the present invention; 
           [0012]      FIG. 3  is a diagram of a patient handset constructed for use in a bio-medical data collection system in accordance with the present invention; 
           [0013]      FIG. 4  is flowchart of a process of using a biomedical sensor that is associated with a wireless mobile handset in accordance with the present invention; 
           [0014]      FIG. 5  is flowchart of a process for enabling a medical provider to receive data from a remote data collection device, and to issue commands to the control the device or sensor in accordance with the present invention; and 
           [0015]      FIG. 6  is a block diagram of processes, algorithms, and data structures used in a medical server in accordance with the present invention; 
       
    
    
     DETAILED DESCRIPTION 
       [0016]    Referring now to  FIG. 1 , a distributed biometric system is illustrated. System  10  advantageously enables the remote collection of biometric data, the automated communication of the biometric data to medical personnel, and the ability of medical providers to react to and control the biometric collection devices. In system  10 , data collection, communication, and control are provided in an authenticated and secure manner, assuring patient privacy as well as safely assisting the delivery of quality medical care. 
         [0017]    Biometric system  10  uses commercially available mobile voice and data communication systems  12 . Mobile communication system  12  may be operated by a telecommunication provider, and may use communication standards promulgated by national or international standards bodies. For example, mobile communication system  12  may comply with CDMA, CDMA 2000, WCDMA, EVDO, EVDV, GSM, GPRS, EDGE, PHS, PCS, or other telecommunication standards. The telecommunication system may also include or rely upon other communication protocols such as WiFi, 802.11, Bluetooth, WiMax, or other local or wide area data network. However, the reach and ubiquitous nature of the mobile telephone systems make the mobile telephone system the network of choice. Accordingly, the descriptions provided herein will describe the invention operating using a mobile telecommunications system, however it will be appreciated that other communication and data networks may be used. 
         [0018]    Mobile communication system  12  enables remote voice and data communication with mobile handsets, such as mobile handsets  14 ,  21 , and  28 . The communication of voice and data between a mobile communication system and its associated mobile handsets is well known, so will not be described herein. In a similar way, the construction and deployment of mobile handsets is well known, so will not be described in detail. In one example, patient handset  14  allows voice communication to human medical providers, as well as data communication with a medical server  31 . In some cases, medical providers  42  and  44  may use medical server  31  to send device control commands to the patient handset  14 . 
         [0019]    Patient handset  14  couples to a medical or biometric sensor  16 . In one example, the medical sensor connects using a cable or line, and in another example, medical sensor  18  connects using a wireless communication, such as Bluetooth. The medical sensors  16  and  18  may be any kind of biometric or medical sensor useful for collecting patient data. For example, the sensors may provide an audio signal for hearing heart, lung, or breathing activity; may sense temperature, heart rate, blood pressure, glucose level, or other blood chemistry information; or may measure skin hydration, environment data, exercise data, or location information. It will be appreciated that the biometric or medical sensors may be constructed and configured to collect a wide range of useful information regarding patients and their environment. 
         [0020]    In another example, patient handset  21  has a medical sensor  23  integrally formed with the handset. In this way, the patient uses a single device for voice and data communication, as well as collecting medical data. Although this structure may provide a particularly efficient housing, the integrally formed medical sensor handset provides less flexibility then the discrete sensors discussed with reference to patient handset  14 . The patient handset  14  or  21  may operate local application software for controlling the handset&#39;s respective sensor or sensors. For example, the patient handset may determine when data is collected and when data is transferred to the medical server  31 . This determination may be done according to a time schedule; may be responsive to data collected at one or more medical sensors; or may be initiated by a local command given by the patient or a medical provider. It will be appreciated that other processes and triggers may be used to start or stop data collection and transfer data to medical server. 
         [0021]    The collected data may be sent to medical server  31 . The data may be sent in near real time, or may be collected and processed in the patient handset and then communicated to the medical server  31  from time to time. The medical server  31  is preferably stationed within the control of the mobile communication system  12 . In this way, enhanced security may be established between patient handsets and the medical server  31 . If the medical server is outside the protected environment of the mobile communication system, then additional authentication processes  33  must be used to assure the private and secure transmission of data, as well as to authenticate access to the medical server. A robust and flexible association and authentication process has been fully described in co-pending U.S. patent application Ser. No. 11/296,077 filed Dec. 7, 2005 and titled “Wireless Controller Device”, which is incorporated herein in its entirety. It will be appreciated that other authentication, association, and security processes may be used. Once the medical server  31  has received data from the patient handsets, that data may be processed or made available for use by medical providers, such as medical provider  42  and  44 . It will be appreciated that medical server  31  may operate automated processes for monitoring received data, and may automatically generate alarms or messages responsive to analyzing patient data. 
         [0022]    In some cases, a medical provider may also be operating remotely, and may use a provider handset  28  for both voice communication and for receiving data from the medical server  31 . Advantageously, biometric system  10  enables secure collection of medical data for patient, the transmission of that medical data to a medical server, and distribution and use of the data by distributed medical providers. Further, data collection and transmission may occur simultaneously with voice communication with the patient. In this way, a medical provider may be in voice communication with a patient while monitoring near real time medical data. 
         [0023]    To this point, the distributed biometric system  10  has been described as a data collection and distribution network. As an extension, system  10  also allows medical providers, such as medical providers  42 ,  44 , and  28  to control and adjust the data collection process. For example, the authenticated medical providers may cause commands to be sent to patient handsets  14  and  21  for changing the way data is collected. These commands may be used with in the patient handset for adjusting the timing of data collection and transmission, or may be used with in medical sensors  16 ,  18  or  23  for adjusting sensor configurations. 
         [0024]    The biometric system  10  may be advantageously used in several practical applications. For example, system  10  may enable the automated and remote monitoring of patients. In this way, medical data is collected according to predefined triggers, and that data may be locally or centrally processed to evaluate patient condition. Responsive to processing the medical data, the medical server or medical providers may determine when a patient needs more direct contact with a medical facility, or in some cases may even initiate or adapt medical treatment by sending commands to a local medical device. In this way, patients may be closely monitored with less intrusion into their lives, and a more advanced medical treatment sought before conditions become critical. More effective medical treatment may thereby be delivered to patients in a more comfortable and timely manner. 
         [0025]    In another example of use, clinical trials may use system  10  for controlling clinical studies. A medical server may be used to notify patients when to take a medication, or may even send commands to local medical devices to administer local doses. The medical server may also interrogate the patient with text messages, and solicit current medical information from the patient, or may call the patient using a voice capability the handset, and have the patient give an oral report. Since the patient handset has one or more local sensors, the medical server may also receive real-time or processed data from patients. In this way, more complete and accurate information may be obtained for trial studies, and patients having complications may be more quickly identified and removed from the study. Further, the cost of managing human clinical studies has skyrocketed, with some studies costing more than $30,000 per patient per year of study. Accordingly, a more efficient way of monitoring patients and collecting data could dramatically reduce study costs and increase the study&#39;s reliability, allowing beneficial drugs to come to market more quickly. 
         [0026]    In other examples, system  10  may be used to monitor athletes to assess performance and stress levels, or may be used to monitor military personnel or police. Also, even though the patient handset has been described as being associated with a single patient, in some cases the patient handset may be a handset used by a medical provider, such as an emergency responder. In this way, the emergency responder moves to the location of the patient, and then uses the patient handset to collect the patient&#39;s medical data, and transmit the patient data to a nearby hospital or other medical provider. In this way, the local hospital or medical provider may better understand patient condition, and either be prepared for the patients arrival, or even direct the patient to an alternative facility. With the efficient and accurate transmission of medical data, time may be saved in moving the patient to a preferred medical treatment location. 
         [0027]    Referring now to  FIG. 2 , a patient handset system  50  is illustrated. Mobile handset  50  is similar to patient handset  21  described with reference to  FIG. 1 , and is intended to operate within a distributed biometric system  10 . Handset  50  has a housing  52  holding a standard mobile handset. Typically, a mobile handset  52  will include a textual or graphical display  58 , input keys  60 , as well as internal circuitry for operating local programs as well as wide area communication. The mobile handset  52  may operate according to one or more wide area connection  54 , such as CDMA, WCDMA, UMTS, GSM, WiFi, or other wide area voice and data network. Typically, these wide-area connections are operated by a communication carrier, and the mobile handsets are particularly constructed to operate in a specific carrier&#39;s network. In some cases, mobile handset  52  also has a local area connection such as Bluetooth or 802.11. The local area connection  56  may be useful for connecting to other medical sensors, or to other peripheral devices such as headsets, medical devices, or hands-free car kits. Handset  52  also has an integrated medical sensor  62 . The medical sensor  62  may be constructed as a stethoscope, a heart rate monitor, a blood pressure monitor, a glucose monitor, or other biometric sensor. The mobile handset  52  may also have control keys  69  for allowing the patient or a medical provider to directly interact with medical sensor  62 . A speaker  64  may also be provided for sounding alarms or giving instructions. It will also be appreciated that the handsets regular speakerphone or earpiece may be used in this capacity. The mobile handset may also have alerts or alarm lights  66  associate with the medical sensor  62 . For example, lights  66  may indicate that a glucose level is dangerously low, or that the medical sensor is no longer receiving a required signal. The display  58  may also be used to display instructions on use of the medical sensor  62 , or may be used for outputting results or alarm information. 
         [0028]    Medical sensor  62  may initiate its data collection responsive to a manual local control, as when a patient or medical provider interacts with control buttons  69 . The medical sensor  62  may also operate responsive to an application running within the mobile handset itself, and thereby may periodically begin data collection, or take data collection responsive to some other application or trigger provided by the mobile handset. In another example, and other local medical sensor provides trigger data for medical sensor  62 . The mobile handset may also receive a command from a medical provider or from a medical server, and responsive to receiving the command, initiate or a just medical sensor  62 . The sensor data may be displayed locally to the patient or local medical provider, or the data may be logged in the memory of the mobile handset. The data may also be sent continuously to an associated medical server in near real time, or may be stored locally and periodically transmitted. Mobile handset  52  may also provide local analysis of data, and present local results to the patient or local medical provider. For example, medical sensor  62  may collect blood glucose information, process the data locally, and process and present the results locally. The raw data or resulting blood level data may then be transmitted to a medical server. 
         [0029]    Referring now to  FIG. 3 , patient handset system  100  is illustrated. Patient handset  100  is similar to patient handset  21  described with reference to  FIG. 1  and has many similarities with patient handset system  50  described with reference to  FIG. 2 . Accordingly, mobile handset system  100  will be described with less detail. Patient handset system  100  has mobile handset  102  having a wide area connection  104  for transmitting and receiving data and voice. Mobile handset  102  also has a local area connection such as Bluetooth, Zigbee, or 802.11. The local area connection may be used to connect to a medical sensor  108 , or to a medical control device  113 , for example. The medical sensor  108  may include various control keys, alarms, and displays. The medical sensor  108  may be, for example, an EKG, ECG, blood pressure, thermometer, pulse, hydration, blood analysis, or glucose sensing device. It will be appreciated that other types of sensors may be used, or that multiple sensors may be connected. In operation, medical sensor  108  is positioned on or adjacent patient, and collects data responsive to a local or remote trigger. From time to time or in real time the medical sensor  108  communicates data back to the mobile handset  102 , which periodically transmits the data back to a medical server. The mobile handset will too may also receive commands from a medical provider or from the medical server for adjusting medical sensor  108 . In this way, a remote medical provider may interact with medical sensor  108  or the application interacting with the medical sensor operating on mobile handset  102 . In another control example, a medical control device  113  also uses the local area connection to interact with the mobile handset  102 . This medical control device  113  may be a pacemaker, IV drip, or medication pump, for example. This medical control device  113  may receive the command directly from mobile handset  102 , or the command may have been initiated from a medical server or a human medical provider, and communicated to the mobile handset via the wide area connection  104 . 
         [0030]    In one specific example, mobile handset  102  is used by a patient having a pain medication administered using a medication pump. The medication pump has a medical control device  113  which sets the flow rate or duty cycle or period of operation. A medical sensor  108  may be attached to the patient to monitor pulse rate, skin hydration, or other biometric indicator of pain. Further, the patient may use mobile handset  102  to communicate verbally to a medical provider. Responsive to receiving data that pain has increased, or responsive to a verbal communication from the patient, a medical provider may send a command to medical control device  113  to increase pain medication. In this way, a medical provider is able to accurately evaluate the patients condition, including speaking with the patient, and enable a change in medication delivery from a remote location. Accordingly, patient system  100  facilitates the timely and efficient delivery of high quality medical care. 
         [0031]    Referring now to  FIG. 4 , a process for using a wireless medical sensor with a mobile handset is illustrated. In process  150 , a medical sensor is placed on or near a patient as shown in block  152 . This sensor may be a discrete sensor that connects or couples to a handset, or may be a sensor integrally formed in a wireless mobile handset. The sensor is configured as shown in block  154 . Configuring the sensor may include using local buttons or local commands from the mobile handset, and may include further instruction or commands from a medical server or remote medical provider. Data collection is triggered as shown in block  156 . Data collection may be triggered by a local command received at the sensor or on the handset, may be provided by an application operating on the mobile handset, or may be responsive to a command received from the medical server or remote medical provider. The collected data may be locally logged into memory as shown in block  161 , and may be locally processed as shown in block  163 . In some cases, the data logging and data processing steps may not be used, with raw data being transmitted to the medical server in near real time. In other cases, the logged data and processed data may be sent to the medical server as shown in block  167 . The data may also be locally displayed, as well as local results on display at  169 . The command may be received at the mobile handset from the wide area connection as shown in block  172 . This command may come directly from the medical server, from a medical provider connected to the medical server, or even from a medical provider operating a mobile handset. 
         [0032]    In another example, a command may be generated locally as shown in block  177 . This local command may be from an application operating on the mobile handset, or may be responsive to a patient or medical provider pressing a key. Any of these instructions may then be used to make adjustments in the data collection process. For example, the instruction may affect how the sensor is configured, what triggers the data collection, the amount of data logged, the type of data processing performed, or the timing of data transmissions. In this way, process  150  facilitates the secure and flexible collection of medical data, the use of the medical data by medical providers irrespective of their location, and the adaptation of the sensor and patient handset. Of course, the patient handset may facilitate voice communication  179  between the patient and medical providers, even while medical data is being collected and transmitted. 
         [0033]    Referring now to  FIG. 5 , a process for a medical provider to access and control a biomedical sensor is illustrated. Process  200  allows a remote medical provider to access medical data, evaluate medical data, and control one or more devices associated with a patient. Although the medical provider may be connected to a medical server, in some cases the medical provider may be operating using a wireless mobile device, such as a portable computer or wireless handset. In these cases, the wireless mobile device provides a secure process for authenticating the medical provider to the medical server as shown in block  202 . Once the medical provider has been authenticated to the medical server, then the medical provider has to be associated with particular patients and their associated remote medical devices as shown in block  204 . In this way, a particular medical provider is only able to access data and control devices for that provider&#39;s set of patients. 
         [0034]    Once the medical provider has been authenticated and associated with their set of patients, the medical provider may select a particular patient, and receive data collected by that patient&#39;s medical sensor or medical sensors. As previously discussed, this data may be real-time, batch transmitted, and may include summary or processed results. The medical practitioner then may view and store this medical data or may provide additional analytic tools as shown in block  211 . Responsive to viewing the data, the medical provider may send a command to remote medical device at the patient&#39;s location as shown in block  213 . This command may be used to further adapt the medical sensor, or may provide control for another device, such as an IV pump, at the patient location. 
         [0035]    In another example, the medical provider may stand messages or data information to other medical providers for collaboration as shown in block  217 . In this way, multiple remote medical providers may cooperate in assisting a single patient, and all providers will be using the same medical data information. While receiving and analyzing medical information from the patient, the medical provider may also be in voice communication with the patient as shown in block  221 . Of course, the medical provider may also use forced vacation  221  to discuss the patient with other medical providers. 
         [0036]    Referring now to  FIG. 6 , medical server processes  225  are illustrated. The connection of a medical server to a mobile communications system, as well as the operation of a general computer server, are well known, so will not be described in detail. Instead, the general processes operating on a medical server are described. Medical server  227  has processes  232  for authenticating and associating mobile devices with the medical server. The authentication and association processes are simplified when the medical server operates with in the controlled environment of the mobile communications system, but the medical server may also be connected on a more general network system such as the Internet. The server has mobile handset authentication information  241 , which is useful for authenticating patient handset to the medical server. The mobile handset authentication information  241  may include the mobile identification number for the handset, a serial number for the handset, IP address for the handset, or other identification information. The authentication information may also have carrier information, and password requirements for the user. Once a handset has been authenticated to the server, the server may then associate a particular patient handset with that handsets authorized biometric sensors, and may provide sensor configuration and interface information as shown in block  243 . This information may be specific to the particular sensor at a patients handset, or may be global to a class of products. In another example, sensors may be configured according to the particular medical requirements of the patient. 
         [0037]    The server  227  also maintains information for authorizing medical personnel  244 . Some medical personnel may login through existing server client processes, while others may access the server using their mobile handsets. For those using the mobile handsets, a mobile handset authentication information system to  46  is provided. In this way, a particular medical provider&#39;s handset may be authenticated to the server, and the medical provider associated with an authorized set of patients and patient records. Logging and legal requirements  248  may also be set on a global basis, a provider bases, or a patient basis. In this way, appropriate records may be maintained as to patient care. 
         [0038]    Processes  232  enable server  227  to communicate with a patients handset and its associated sensors, as well as access rules specific to that patient. For example rules  234  may include rules for when the server initiates data collection as shown in block  251 . Alternatively, authorized medical personnel may initiate data collection as shown in block  253 , or a patient may be allowed to initiate the collection as shown in block  255 . In other cases, other remote devices may be allowed to trigger or initiate data collection as shown in block  257 . The data collection rules also may include information as to the trigger for initiating data collection, how much data to store locally, then to transmit data to medical server, and what type of local display and processing may be allowed. In some cases, the collected medical data may be processed locally and used for further adapt in the medical sensor or local application. 
         [0039]    In other cases, server analytics  236  are applied to the received medical data by server  227 . Processing routines  262  may be applied to incoming data, and provided certain thresholds or patterns are seen, notifications may be sent to medical providers  264  or alarms may be generated  266 . The medical provider notifications  264  may include messages, automated phone calls, or other forms of notification. The alarm may also be used to notify medical providers, or may be set as a sound, illumination, or display on the patients handset. For example, if the processing routines  260  to determine that a heart rate is too high, a local alarm may be sounded at the patient&#39;s handset to warn the patient to reduce their level of exertion. In another example, responsive to the processing routines to  62 , the server may send commands to the patient&#39;s handset to  68 . These commands may then be used to adapt or configure the medical sensor, or may be used to set operation of another local medical device. 
         [0040]    While particular preferred and alternative embodiments of the present intention have been disclosed, it will be appreciated that many various modifications and extensions of the above described technology may be implemented using the teaching of this invention. All such modifications and extensions are intended to be included within the true spirit and scope of the appended claims.