Abstract:
A method and system for the collection and centralized storage of medical information stored in implantable medical devices and associated programming devices. The system comprises a clinician programmer, a patient programmer, an implanted medical device, and a communication network for storing data found on these devices into a central database for report generation.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention relates generally to a method and system for electronic data management of patient medical information. More particularly, this invention allows for the collection of medical information from an implantable medical device and associated programming devices into a centralized database for analysis and report generation.  
         BACKGROUND OF THE INVENTION  
         [0002]    The medical device industry provides a wide variety of electronic and mechanical devices for treating patient medical conditions. Implantable medical devices are commonly used today to treat patients suffering from various aliments such as pain, spasticity, and cancer. Clinicians use implantable devices separately or in combination with each other to provide the most effective therapy.  
           [0003]    Implantable medical devices include pacemakers, defibrillators, neurostimulators, and drug pumps. These devices provide treatment by delivering electrical stimulation or therapeutic drugs to various portions of a patient&#39;s body. In the case of providing electrical stimulation, an implantable neurostimulator (“INS”) is implanted within a patient&#39;s body. The implantable neurostimulator is coupled to one or more electrodes that provide electrical energy to select portions of a patient&#39;s body. In the case of providing therapeutic drugs to a patient, a pump is implanted within the patient&#39;s body. The pump is coupled to a catheter that delivers therapeutic drugs to select portions of the patient&#39;s body.  
           [0004]    In order to monitor, adjust, and collect data regarding a patient&#39;s therapy from an implantable medical device, various controllers have been developed that communicate via telemetry with the implantable medical devices. These controllers are typically computers that can communicate with the implantable medical device. Two such controllers that are used with implantable medical devices are clinician programmers and patient programmers. Both clinician programmers and patient programmers provide users with the ability to communicate with the implantable medical device. The clinician programmer is provided with full functionality whereas the patient controller is provided with limited functionality. The setup is by design as clinicians utilize the clinician programmer to program the therapy regiment whereas the patient controller is used by a patient to make changes to the therapy regiment within defined limits as established by the clinician.  
           [0005]    Both the clinician programmer and the patient programmer may independently contain valuable information that can be useful in determining the effectiveness of the treatment regiment. Presently, the data must be viewed separately as the data is not contained in centralized database. Therefore, the only way to view all of the data is to separately view the data from each device. The viewing of all of the information from all of these devices simultaneously and frequently is cost prohibitive and not practical as patients and clinicians have busy schedules and can not meet at great frequencies.  
           [0006]    There exists, therefore, a significant need for a method and system to collect the information from all of the devices involved in the therapy into a centralized database that can be used to analyze and generate comprehensive reports regarding a patient&#39;s therapy. The present invention overcomes these and other disadvantages of the prior art.  
         BRIEF SUMMARY OF THE INVENTION  
         [0007]    According to an embodiment, a data management system of the present invention includes a clinician programmer, a patient programmer, an implantable medial device, and a network for transmitting data from the patient programmer and the clinician programmer to a server to store data in a centralized database.  
           [0008]    Additionally, according to a second embodiment, a method of collecting data from an implantable medical device system is disclosed. The method receives input from a first device, the first device comprising data from the implantable medical device. Next, the method receives input from a second device, the second device comprising data from a user. The first device and the second device are connected to a network server to store the data in a database. The server can generate reports from the database based on a users request for data. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0009]    These and other advantages and features will become apparent upon reading the following detailed description and referring to the accompanying drawings in which like numbers refer to like parts throughout and in which:  
         [0010]    [0010]FIG. 1A is a schematic diagram of a clinician and patient programmer as used with an implantable neurostimulator in an embodiment of the present invention.  
         [0011]    [0011]FIG. 1B is schematic diagram of a clinician programmer and a patient programmer connecting to a network in an embodiment of the present invention.  
         [0012]    [0012]FIG. 1C is schematic diagram of a patient programmer connecting to a network in an embodiment of the present invention.  
         [0013]    [0013]FIG. 2A- 2 B are multiple view diagrams of the clinician programmer in accordance with an embodiment of the present invention.  
         [0014]    [0014]FIG. 2C is a block diagram of a clinician programmer in accordance with an embodiment of the present invention.  
         [0015]    [0015]FIG. 3 is a block diagram of a patient programmer in accordance with an embodiment of the present invention.  
         [0016]    [0016]FIG. 4 is block diagram of a remote telemetry unit in accordance with an embodiment of the present invention.  
         [0017]    [0017]FIG. 5 is a flow chart depicting the connection of the clinician programmer and the patient programmer with a server.  
         [0018]    [0018]FIG. 6 is a flow chart depicting the authentication of data from a remote device in accordance with an embodiment of the present invention.  
         [0019]    [0019]FIG. 7 is flow chart depicting the synchronization of data between a server and remote devices in accordance with a preferred embodiment of the present invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0020]    Although the preferred invention is shown for use with an implantable electrical stimulation system, those skilled in the art will appreciate that the data management system of the present invention may also be used with any implantable device such as drug delivery system, or even a combination electrical stimulation/drug delivery system.  
         [0021]    Referring to FIG. 1A, the data management system of the present invention generally includes a clinician programmer  102 , a patient programmer  104 , an implantable medical device  110 , and a network  150 , (FIG. 1B), for the transfer of data to a centralized database. Those skilled in the art will appreciate that the clinician programmer  102  and patient programmer  104  may be portable hand-held devices but are not limited to such devices. In addition, the system of the present invention is shown in use with an implantable neurostimulator, but those skilled in the art will appreciate that the system of the present invention may be used generally with any sort of implantable medical device including, but not limited to neurostimulators, drug delivery devices, pacemakers, defibrillators, and cochlear implants. As shown in FIG. 1A, the clinician programmer  102  and the patient programmer  104  allow for the adjusting and monitoring of the implantable neurostimulator  110  during therapy execution with the patient  115 . Each of these components may be powered by separate power sources such as rechargeable batteries. The implantable neurostimulator  110  may be placed in any number of locations within the body, including the abdominal region. The implantable neurostimulator  110  is coupled to a lead  16  that terminates in one or more electrodes  18  that deliver the desired stimulation therapy to the body. In the exemplary embodiment of FIG. 1, the electrodes  18  are positioned to stimulate a spinal cord  12  of patient  115 .  
         [0022]    In the embodiment where the implantable medical device  110  is a neurostimulator, the device may be a signal generator having a processor or like circuitry. For example, signal generator may take the form of commercially available signal generators like Itrel 7, X-trel 7, or Mattrix 7 (manufactured by Medtronic, Inc. of Minneapolis, Minn.), which are incorporated herein by reference. Where the implanted medical device  110  is a drug delivery system, the implanted drug delivery system would generally consist of a drug delivery pump coupled to one or more catheters having drug delivery ports on the distal ends. Those skilled in the art will appreciate that the clinician programmer  102  and the patient programmer  104  are suited for uses with any known or future developed implantable medial device  110 . Those skilled in the art will also appreciate that the implanted medical device  110  for use with the present invention can take many forms and embodiments. For example, the implanted medical device  110  may be a system that provides a combination of electrical stimulation and drug delivery. FIG. 1B and the particulars of the individual components of the electronic data management of the present invention are discussed in further detail below.  
         [0023]    [0023]FIG. 2A depicts views of the clinician programmer  102  including a front view,  203 , a top view  202 , a bottom view  204 , a back view  205 , a left side view  208 , and right side view  207 . The clinician programmer  102  is preferably a portable computing device having a user interface. The user interface preferably includes a screen display  201  that is touch sensitive to a pointing device  206 , similar to that of a Personal Digital Assistants (PDA) available today. On the dorsal side of the clinician programmer  102  is an area to receive and hold the remote telemetry unit  240 . FIG. 2B illustrates how the remote telemetry unit  240  is stored within the dorsal side of the clinician programmer  102 .  
         [0024]    [0024]FIG. 2C depicts the general componentery of the clinician programmer  102 , which includes a user interface  260 , a processor  265 , a transmitter  215 , and a receiver  220 . The clinician programmer  102  acts as the control interface to the implantable medical device  110 , which is generally directed by the computer software application in the clinician programmer  102 . The application program software for handling the functionality of the clinician programmer  102  is stored in memory  225 . In addition, the memory  225  of the clinician programmer  102  may contain performance parameters of the implantable medical device  110 . The data contained in clinician programmer memory  225  may be useful in assembling comprehensive reports on the status of the therapy, and the equipment administering the therapy to the patient. The present invention would allow for all the data that is logged inside the clinician programmer on a compact flash card, in flash memory, or in RAM memory of the clinician programmer  102  to be synchronized and stored in a centralized database.  
         [0025]    As shown in FIG. 3, the patient controller  104  is preferably a computing device, such as a portable computer or personal digital assistant, having a user interface  310 . Patient programmer  104  is similar to clinician programmer  102  except that it has limited functionality. Typically, patient programmer  104  will be limited such that the patient may adjust settings of the implanted medical device  110  only within a range, such as that specified by the treating clinician. The patient programmer  104  includes similar circuitry such as a microprocessor  320  and memory  340  as that of the clinician programmer  102 . The patient programmer  104  also preferably includes an internal telemetry unit  330  that is similar to the remote telemetry unit  240  of the clinician programmer  102 .  
         [0026]    As shown in FIG. 4, the remote telemetry unit  240  is a relatively small device used to conveniently provide communication between the clinician programmer  102  and the implanted medical device  110 . Remote telemetry unit  240  generally includes a telemetry coil  405 , a receiver  410 , a transmitter  415 , and telemetry processor  420 . Telemetry is preferably conducted at a frequency in the range from about 150 KHz to 200 KHz using a medical device protocol such as described in U.S. Pat. No. 5,752,977 “Efficient High Date Rate Telemetry Format For Implanted Medical Device” issued to Grevious et al. (May 19, 1998). The telemetry coil  405  can be located inside the housing of the remote telemetry unit  240  or attached to the outside of the housing. The receiver  410  provides a digital pulse representing the Radio Frequency (RF) modulated signal received from the clinician programmer  102  and the implanted medial device  110 . The transmitter  415  generates an RF modulated signal from the digital signal generated by the telemetry processor  420 . The telemetry processor  420  can be a state machine configured on an ASIC with the logic necessary to decode telemetry signal during reception. The telemetry processor  420  also provides the logic necessary during transmission.  
         [0027]    The telemetry module of the patient programmer  104  provides bi-directional communications between the implantable medical device  110  and the patient controller  104 . The telemetry module  330  of the patient programmer  104  also generally comprises a telemetry antenna, a receiver, a transmitter, and a telemetry processor (components not shown). Telemetry modules are generally know in the art and are further detailed in U.S. Pat. No. 5,752,977, entitled “An Efficient High Data Rate Telemetry Format For Implanted Medical devices issued to Grevious et al. (May 19, 1998), which is incorporated herein by reference in its entirety.  
         [0028]    Referring back to FIG. 1B depicted is a schematic diagram illustrating clinician programmer  102  connected to a computer network  150  through a computer  160 . Those skilled in the art will recognize that computer  160  could be any general-purpose computing device capable of connecting and transferring data to and from a network. The connection  165  of the clinician programmer  102  to the computer  160  may be accomplished through the use of a serial cable, as illustrated. Those skilled in the art will recognize that the connection  165  between the clinician programmer  102  and the computer  160  may be accomplished in many ways that may include, for example and without limitation, the use of USB ports, infrared ports, modem connections, and wireless connections.  
         [0029]    In an embodiment of the present invention, patient data from the clinician programmer  102  may be synchronized with patient data on the computer  160 . The synchronization process maintains data consistency and integrity between the computer  160  and the clinician programmer  102  as the latest information stored on the clinician programmer  102  is transferred and stored on the computer  160 , and vice versa. Through synchronization the information stored in the clinician programmer will be available for review on computer  160 . The information stored in computer  160  may be placed in a database for easy access. Additionally, through synchronization, information may be transferred to the clinician programmer  102  from the network  150  and will be available to the clinician programmer  102  after synchronization.  
         [0030]    Computer  160  may be operated in a network environment so that computer  160  may be connected to other computers or servers. As shown in FIG. 1B, computer  160  is connected to network  150 . In a business environment, network  150  may be a local area network providing connections to the Internet via a Wide Area Network. In a patient home user environment, network  150  may be an Internet Service Provider&#39;s Network enabling computer  160  access to the World Wide Web. Those skilled in the art will recognize that the connection of computer  160  to the Internet may take many different forms and embodiments. The connection of computer  160  to the Internet allows for the information stored in computer  160  to be accessible by any remote computer connected to the Internet. Additionally, the database information collected on computer  160  from clinician programmer  102  can be stored in different databases located on different severs.  
         [0031]    Patient programmer  104  can be synchronized to the clinician programmer  102  or to computer  160 . The communication between clinician programmer  102  and patient programmer  104  may be accomplished through the use of low-power RF or IR signaling  185  as illustrated in FIG. 1B. Additionally, those skilled in the art will recognize that the connection between the clinician programmer  102  and the patient programmer  104  may also be made through use of any number of ways including, but not limited to, USBA connectors, RS  232  cables, infrared transmitters, or wireless devices. This communication ability allows the clinician programmer  102  and patient programmer  104  to synchronize information. Optionally, the patient programmer  104  may be synchronized with the computer  160  similar to that of the clinician programmer  102 , as shown in FIG. 1C. The patient controller  104  may be coupled to the network  150  either directly through a modem or may be networked to a computer  160  that is coupled to the network  150  through know techniques.  
         [0032]    [0032]FIG. 5 is flow chart depicting the process of creating various reports from a centralized database, the data provided by the implantable device  110 , the clinician programmer  102 , and the patient programmer  104 . At step  505 , a clinician interrogates the implantable neurostimulator  110  with the clinician programmer  102 . The implantable neurostimulator  110  may provide the clinician programmer  102  with certain diagnostic information such as parameter settings (e.g. stimulation frequency, stimulation pulse amplitude, stimulation pulse width, electrode configuration, etc.), patient diagnostic data (e.g., usage data), system diagnostic data, (e.g., battery status, estimated longevity of implanted device, lead system integrity, load impedance, etc.), data on device usage, the state of the device, and whether a valid communication channel exists, and the like.  
         [0033]    At step  510 , the clinician interrogates the patient programmer  104  with the clinician programmer  102 . The patient programmer  104  may provide the clinician programmer  102  with similar information from the implantable medical device  110 , but may also provide additional data such as the actual therapy programs used by the patient, the number of requests for increased and decreased therapy dosages, and the frequency of patient interaction with implantable medical device  110 .  
         [0034]    At step  515 , the clinician reprograms the implantable neurostimulator  110  with the clinician programmer  102 . Similarly, at step  520  the clinician reprograms the patient programmer  104  with the clinician programmer  102 . The reprogramming may be necessary due to changes in the therapy treatment. Additionally, reprogramming may be necessary after updates to the software residing on both the clinician programmer  102  and the patient programmer  104  are implemented.  
         [0035]    At step  525 , the clinician programmer  102  creates a session data file. The data session file may contain all the information stored in the clinician programmer  102  as provided by the INS device  110  and the patient programmer  104 .  
         [0036]    At step  530 , the clinician connects or docks the clinician programmer  102  to a computer or server to transfer the data file to the network and in particular to a database on the network. Those skilled in the art will recognize that the connection to the network may be made in numerous ways in order to transfer the data file to network database.  
         [0037]    On a parallel path to that of the clinician&#39;s actions, the patient may interrogate and reprogram the implantable medical device  110  with the patient programmer  104  as shown in step  535 . At step  540 , the patient docks or connects the patient programmer  104  to a computer or server to transfer data to the network and in particular to a database on the network. This parallel path may ensure that the current information contained in the patient programmer  104  is stored in the database no the network. For example, if a patient is on an extended vacation, a clinician may not be able to interrogate the patient programmer  104  with the clinician programmer  102 . In this situation, the patient can connect the patient programmer  104  to a personal computer or sever and directly synchronize the data on the patient programmer with the data stored in the network database. This will allow those who access the network database to have the latest information for analysis and report generation.  
         [0038]    At step  545 , the server authenticates the data source whether from the data is being sent from the clinician programmer  102  or the patient programmer  104 . The authentication process is to ensure that the data about to be transferred into the network database is from a recognized device.  
         [0039]    At step  550 , the server synchronizes data from the clinician programmer  102 , and or the patient programmer  104 . At step  555 , the data can be analyzed and reports formatted for various media incorporating the collected data from any computer device capable of accessing and displaying information from the network.  
         [0040]    [0040]FIG. 6 is flow chart depicting a method of authenticating the data as discussed above. At step  605 , the server receives a request for connection. This request for connection may be from the clinician programmer  102  or the patient programmer  104 . At step  610 , the sever queries the connected device for an encrypted ID. The server then determines in step  615  if the remote device is a recognized instrument. If the device is a recognized instrument, then the server records the instrument model/serial number and/or ID along with a timestamp in a log file. If the remote device is not found to be a recognized instrument in step  615 , then the request is diverted to a user login screen for browsing. Following the recording of the instrument model/serial number, ID, and timestamp in the log file in step  620 , the data is approved for synchronization in step  630 .  
         [0041]    [0041]FIG. 7 depicts a flow chart demonstrating the steps for synchronization of data from a clinician programmer  102  or a patient programmer  104  as embodied in the present invention. As shown in step  705 , the server establishes a connection with the remote system. The remote system may comprise the patient programmer  102 , the patient programmer  104 , or both.  
         [0042]    In step  710 , the remote system adds a timestamp to the data file and transfers the data file to the server. The server after receipt of the data file adds its own timestamp to the data file in step  715 . In step  720 , the server creates a new universal timestamp for all data within the data file by adding the offset determined by the difference between the server timestamp and the remote system timestamp.  
         [0043]    In step  725 , the server decodes the ID data from the remote system.  
         [0044]    In step  730 , the server determines whether the ID is from a recognized INS system. If the ID is from a recognized INS system then the server retrieves a database file for the model/serial number of the INS. If the ID is not from a recognized INS system, step  730 , then the server searches for a database file with common patient ID&#39;s, patient programmer model/serial numbers, and/or clinician programmer model and serial numbers in step  740 .  
         [0045]    In step  745 , the server compares the timestamp of the data file received with the timestamps of the stored database files. The server in step  750  determines whether the universal timestamp is unique. If the universal timestamp is unique then in step  755  the date is merged into the database file. If the universal timestamp is step  750  is not unique, then the server compares the data source with that of other common timestamps in step  760 . The server in step  765  determines whether the data source is common. If the data source is not common then the data is merged into the database file in step  775 . If the data source is common, then in  770  the server compares the data with that of other common timestamps. The comparison with other common timestamps is to determine whether the data is identical. The server in step  780  determines whether the data is identical. If the data is identical the data is discarded in step  785 . If the data is not identical then in step  790  the data file is saved with the database file in step  790  and is flagged for user review.  
         [0046]    While the invention has been described with respect to specific examples including presently preferred modes of carrying out the invention, those skilled in the art will appreciate that there are numerous variations and permutations of the above described systems and techniques that fall within the spirit and scope of the invention as set forth in the appended claims.