Portable Device and Method Of Communicating Medical Data Information

Abstract

A portable medical device for communication of medical data information has a medical device part that includes a first processor and first storage means, and means for executing one or more medical related functions, a communication device part comprising a second processor, second storage means, and communication means. The medical device part and the communication device part are connected allowing for exchange of data information according to a predetermined protocol. The exchange of communication may be under the control of the medical device part, but the functionalities of each device part otherwise is separated providing for easy interchangeability of the communication device part or the medical device part. Also disclosed is a method for communication of medical data information.

1 . A method of communicating medical data information between a medical device part comprising:
 providing a medical device part which is approvable according to preset validation standards for medical device parts, the medical device part comprising:
 at least one of a discrete or substantially continuous body fluid analysis means, 
 a drug administration means, 
 a first processor and first storage means, 
 a means for executing one or more medical related functions, and 
 a physical interface; 
   a communication part which is approvable according to preset validation standards for communication parts, the communication part comprising:
 a second processor, a second storage means, 
 a communication means, and 
 a physical interface; 
   wherein the medical device part and the communication part exchanges data information according to a predetermined protocol, the exchange of data information via said physical interface according to a predetermined protocol, the exchange of data information is under the control of the medical device part wherein the functionalities of each device part otherwise is separated, and wherein the communication part is optionally interchanged with a second communication part without affecting the medical device part validation according to preset standards for medical device parts.   
     
     
         2 . A method according to  claim 1 , wherein the predetermined protocol comprises the medical device part acting as a master and the communication device part acting as a slave where the exchange of information is done by the medical device part polling the communication device part. 
     
     
         3 . A method according to  claim 2 , wherein the medical device part further comprises one or more of:
 a user interface,   at least one medical transducer, and   a short-range communication means for exchanging data information with at least another medical device.   
     
     
         4 . A method according to  claim 3 , wherein the at least another medical device is selected from the group of:
 a drug administration device,   a body fluid analyzer,   an insulin administration device,   a blood glucose monitor (BGM),   a continuous blood glucose monitor (CGM),   an inhaler,   a tablet dispenser,   a lipid monitor,   a pulse monitor.   a lancet device,   a storage container,   a balance, and   any other apparatus adapted to measure at least one physiological parameter.   
     
     
         5 . A method according to  claim 4 , wherein the method further comprises controlling a power supply by the medical device part, where the power supply supplies the communication device part with power. 
     
     
         6 . A method according to  claims 5 , wherein said communication means communicates according to the Bluetooth protocol. 
     
     
         7 . A method according to  claim 6 , wherein said communication means communicates information according to one or more of:
 Radio frequency (RF) communication,   Infrared (IR) communication,   HTTP (Hyper Text Transmission Protocol),   SHTTP (Secure Hyper Text Transmission Protocol),   TCP/IP (Transmission Control Protocol/Internet Protocol),   PPP (Point-to-Point),   SSL (Secure Socket Layer),   TLS (Transport Layer Security), and   IrDA,   
     
     
         8 . A method according to  claim 7 , wherein said communication means communicates with a wireless access point/a mobile terminal where the access point/the terminal communicates according to one or more of:
 GSM (Global System for Mobile communication),   GPRS (General Packet Radio System), and   UMTS (Universal Mobile Telephone System).   
     
     
         9 . A method according to  claim 8 , wherein the communication device part exchanges data information with a central server via a wireless network access point. 
     
     
         10 . A method of supplying data from a portable medical device to a third party, the method comprising:
 automatically transmitting data information from a portable medical device to a central server for storage in at least one database,   processing said data information, in order to derive additional information, and   automatically transmitting at least a part of the additional information to a predetermined third party.   
     
     
         11 . The method according to  claim 10 , wherein said processing is done at said server and/or at said medical device. 
     
     
         12 . The method according to  claim 11 , wherein said data information comprises information representing one or more of:
 at least one blood glucose value,   at least one value representing a body fluid level,   at least one physiological parameter,   amount and/or type of administered medication,   amount and/or type of administered insulin,   a trend of a glucose or body fluid level,   a prediction of a glucose or body fluid level,   timestamp in- or excluding date,   amount of food,   measurement of physical activity,   notification of appointment,   inventory logistics, and   body characteristics.   warnings, and   symptoms.   
     
     
         13 . The method according to  claim 12 , wherein said step of transmitting data information from a portable medical device to a central server is done by transmitting said data information according to the Bluetooth protocol to a wireless access point connected via a network to the central server. 
     
     
         14 . The method according to  claim 13 , wherein said third parties are one or more of:
 at least one relative,   at least one parent, and   at least one medical professional.   
     
     
         15 . The method according to  claim 14 , wherein said method further comprises communicating between the portable medical device and another medical device in order to retrieve relevant data information. 
     
     
         16 . A medical system for assisting in the treatment of a human patient, the system comprising:
 a.) a medical part comprising:
 i.) hardware comprising a computer readable medium encoded with a computer program, wherein the medical part is structured to be approvable according to preset validation standards for medical parts, and the computer readable medium encoded with a computer program is configured to be approvable according to preset software validation standards for software, and 
 ii.) a medical part processor; 
   b.) a communication part that comprises a communication means for communicating with other devices;   c.) a physical interface between the medical part and the communication part; and   d.) an interface layer that facilitates communication across the physical interface,   wherein the interface layer is under control of the medical part processor; and wherein the communication part is structured to be interchanged with a second communication part without affecting the medical part or software validation according to preset standards for medical parts and software.   
     
     
         17 . The system of  claim 16 , wherein at least one of the medical part and the communication part further comprises a storage unit for storing data. 
     
     
         18 . The system of  claim 16 , wherein the medical part acts a master and the communication part acts as a slave. 
     
     
         19 . The system of  claim 16 , wherein the medical part is capable of performing medical functionalities and the communication means is capable of performing communication functionalities and wherein the communication functionalities and medical functionalities are separated from each other. 
     
     
         20 . The system of  claim 16 , wherein the computer program comprises at least one of software or firmware.