Portable device and method of communicating medical data information

• US 10,016,134 B2
• Filed: 06/08/2010
• Issued: 07/10/2018
• Est. Priority Date: 08/13/2001
• Status: Expired due to Fees

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Hansen, Henrik Egesborg, Eilersen, Michael, Rolsted, Niels Pryds
• Primary Examiner(s): Thomson, William
• Assistant Examiner(s): JIAN, SHIRLEY XUEYING
• Application Number:
  US12/796,373
• Publication Number:
  US 20100250697A1
• Time in Patent Office: 2,954 Days
• Field of Search: 600300-301
• CPC Class Codes: A61B 5/0017 transmitting optical signals transmission by light H04B10/00
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: H04W 88/02 Terminal devices

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.

Claims

1. A method of communicating medical data information of a portable unitary integrated medical device, the method comprising:

providing the portable unitary integrated medical device comprising;

a medical part comprising;

at least one apparatus selected from the group consisting of;

a discrete or substantially continuous body fluid analysis apparatus structured to monitor one or more bodily parameter(s), and

a drug administration apparatus structured to administer or direct administration of an agent to a patient,

a first processor,

a first storage apparatus, and

a first physical interface; and

a communication part comprising;

a second processor,

a second storage apparatus,

a communication apparatus configured for communication with at least one other medical device, and

a second physical interface;

internal exchanging of the data information between the medical part and the communication part; and

external exchanging of the data information between the communication part and the at least one other medical device;

wherein;

the medical part and the communication part are unitary physically integrated and connected via their respective first and second physical interfaces and the internal exchanging occurs only according to a predetermined protocol, functionalities of each of the medical and communication parts otherwise being separate;

the predetermined protocol comprises the medical part acting as a master and the communication part acting as a slave, such that;

the internal exchanging is initiated and controlled by the medical part solely; and

the external exchanging is performed by the communication part solely.

2. The method according to claim 1, wherein the medical part complies with preset validation standards for medical devices, the communication part complies with preset validation standards for communication devices, and wherein the communication part is able to be interchanged with a second communication part without affecting the medical part'"'"'s compliance with the preset validation standards for medical devices.

3. The method according to claim 1, wherein the medical part further comprises one or more of:

a user interface, and

at least one medical transducer.

4. The method according to claim 1, wherein the at least one other 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,

another said portable unitary integrated medical device and

any other apparatus adapted to measure at least one physiological parameter.

5. The method according to claim 1, wherein the method further comprises controlling a power supply by the medical part, where the power supply supplies the communication part with power, and where the power supply may be turned on and off under the control of the medical part.

6. The method according to claim 1, wherein the communication part communicates according to the IEEE 802.15.1 protocol.

7. The method according to claim 1, wherein the communication part 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),

short-range communication, and

IrDA.

8. The method according to claim 1, wherein the communication part communicates with a wireless access point and/or a mobile terminal, where the access point and/or 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. The method according to claim 1, wherein the communication part exchanges data information with a central server via a wireless network access point.

10. The method according to claim 1, further comprising:

automatically transmitting the data information from the communication part to a central server for storage in at least one database,

processing the data information, in order to derive additional information, and

automatically transmitting at least a part of the additional information to a predetermined third party selected from the group consisting of;

at least one of a relative,

at least one parent, and

at least one medical professional.

11. The method according to claim 10, wherein said processing is done at said server and/or at said portable medical device.

12. The method according to claim 10, 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,

body characteristics,

warnings, and

symptoms.

13. The method according to claim 10, wherein the transmitting data information from the communication part to the central server is done by transmitting the data information according to the IEEE 802.15.1 protocol to a wireless access point connected via a network to the central server.

14. The method according to claim 13, wherein said method further comprises retrieving relevant data information from the at least one other medical device.

15. A portable medical device for communication of medical data information, the device comprising:

a medical part comprising;

at least one apparatus selected from the group consisting of;

a discrete or substantially continuous body fluid analysis apparatus structured to measure one or more bodily parameter(s), and

a drug administration apparatus structured to administer or direct administration of an agent to a patient,

a first processor and first storage apparatus, and

a first physical interface; and

a communication part comprising;

a second processor,

a second storage apparatus,

a communication apparatus, configured for communication with at least one other medical device and external exchange of their data information, and

a second physical interface;

wherein;

the medical part and the communication part are unitary and physically integrated and connected via their respective first and second physical interfaces and internal exchange of the data information between one another occurs only according to a predetermined protocol, functionalities of each of the medical and communication parts otherwise being separate;

the predetermined protocol comprises the medical part acting as a master and the communication part acting as a slave, such that;

the internal exchange initiated and controlled by the medical part solely; and

the external exchange is performed by the communication part solely.

16. The portable medical device according to claim 15, wherein the medical part complies with preset validation standards for medical devices, the communication part complies with preset validation standards for communication devices, and wherein the communication part is structured to be interchanged with a second communication part without affecting the medical part'"'"'s compliance with the preset validation standards for medical devices.

17. The portable medical device according to claim 15, where the communication part is further adapted to:

automatically transmit data information from the portable medical device to a central server for storage in at least one database,

process said data information, in order to derive additional information, and

automatically transmit at least a part of the additional information to a predetermined third party selected from the group consisting of;

at least one medical professional,

at least one relative, and

at least one parent.

18. The medical device of claim 17, wherein the medical part further comprises hardware comprising a computer readable medium encoded with a computer program, wherein the computer program comprises at least one of software or firmware.

19. The medical device according to claim 17, wherein said processing is done at said server and/or at said medical device.

20. The medical device according to claim 17, 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,

body characteristics,

warnings, and

symptoms.

21. The medical device according to claim 17, wherein the communication part is structured to transmit data information according to the IEEE 802.15.1 protocol from the communication part to a wireless access point connected via a network to the central server.

22. The medical device according to claim 17, wherein the communication part is further configured to retrieve relevant data information the at least one other medical device.

23. The system for collecting data information from a number of portable devices according to claim 15, wherein the system is structured to:

generate data information in at least one of the portable devices, the data information relating to a clinical trial of the medical part and/or medical product,

automatically send the data information from the communication part to a central server for storage in a database, and

process said data information.