U.S. patent application number 12/017369 was filed with the patent office on 2008-07-24 for portable device and method of communicating medical data information.
This patent application is currently assigned to Novo Nordisk A/S. Invention is credited to Michael Eilersen, Henrik Egesborg Hansen, Niels Pryds Rolsted.
Application Number | 20080177154 12/017369 |
Document ID | / |
Family ID | 39641952 |
Filed Date | 2008-07-24 |
United States Patent
Application |
20080177154 |
Kind Code |
A1 |
Hansen; Henrik Egesborg ; et
al. |
July 24, 2008 |
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.
Inventors: |
Hansen; Henrik Egesborg;
(Hellerup, DK) ; Eilersen; Michael; (Hvidovre,
DK) ; Rolsted; Niels Pryds; (Vaerlose, DK) |
Correspondence
Address: |
NOVO NORDISK, INC.;INTELLECTUAL PROPERTY DEPARTMENT
100 COLLEGE ROAD WEST
PRINCETON
NJ
08540
US
|
Assignee: |
Novo Nordisk A/S
Bagsvaerd
DK
|
Family ID: |
39641952 |
Appl. No.: |
12/017369 |
Filed: |
January 22, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10216680 |
Aug 7, 2002 |
|
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12017369 |
|
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|
60315085 |
Aug 27, 2001 |
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Current U.S.
Class: |
600/300 |
Current CPC
Class: |
G16H 40/67 20180101;
A61B 5/1468 20130101; A61B 5/0022 20130101; A61B 5/157 20130101;
A61B 5/002 20130101; A61B 5/4839 20130101; H04W 88/02 20130101;
A61B 5/4833 20130101; A61B 5/0017 20130101; A61B 5/14532
20130101 |
Class at
Publication: |
600/300 |
International
Class: |
A61B 5/00 20060101
A61B005/00 |
Foreign Application Data
Date |
Code |
Application Number |
Aug 13, 2001 |
DK |
PA 2001 01210 |
Claims
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.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Continuation-In-Part of U.S.
Non-Provisional application Ser. No. 10/216,680 (filed on Aug. 2,
2002), and which claims the benefit of priority under 35 USC .sctn.
119 of U.S. Provisional Application 60/315,085 (filed on Aug. 27,
2001) and Danish Application PA 2001 01210 (filed Aug. 13, 2001),
all of which are hereby incorporated by reference in their
entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to a portable medical device
for communication of medical data information.
[0004] The present invention also relates to a method of
communication of medical data information by a portable medical
device.
[0005] 2. Related Art
[0006] Product and software validation for medical products are
troublesome, delays a product's time-to-market, time-consuming,
complicates revision tasks, and is expensive.
[0007] For example, in some jurisdictions, regulatory bodies govern
the approval of medical products (e.g., devices) according to
preset validation standards for medical products. Likewise,
regulatory bodies typically also govern the approval of any
software contained within medical products according to preset
validation standards for medical product software. For example, in
the United States the Food and Drug Administration (FDA) has issued
a document entitled, "Design Control Guidance for Medical Device
Manufacturers," on Mar. 11, 1997, which provides criteria for
approval of medical product (e.g., device) design according to its
established preset validation standards. Likewise, with regard to
software, the FDA has issued a document entitled "General
Principles of Software Validation; Final Guidance for Industry and
FDA Staff" on Jan. 11, 2002 (which supersedes an earlier document
dated Jun. 9, 1997), which provides criteria for approval of
software according to its established preset validation
standards.
[0008] Medical products (e.g., devices) can further include
communication parts (e.g., Bluetooth, 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), GSM (Global System for Mobile
communication), GPRS (General Packet Radio System), UMTS (Universal
Mobile Telephone System), and IrDA, among others) of which the
general design and operation of the communication parts are
governed and/or regulated by standards setting bodies which provide
criteria for approval of communication parts according to
established preset validation standards.
[0009] It has heretofore been known to fully integrate
communication parts and software within the medical products, such
that approval of each of the communication part, the medical
product (e.g., device), and the software is required, each
according to preset validation standards in their appropriate
technology and/or jurisdiction. However, the full integration of
the communication part or software within the medical product can
require renewed approval of the entire medical product (i.e.,
device and software) if any revisions are made to either the
communication part, medical product (e.g., device) itself, or any
software contained in the medical product. Thus, revisions of
either the communication part, medical product (e.g., device) or
any software contained in the medical product can delay a product's
time-to-market, be time-consuming, complicates revision tasks, and
can be expensive.
[0010] Rapid development in the field of communication requires for
frequent updates of communication soft-, hard- and/or firmware in a
medical device. As a result medical product and software validation
is required for a medical device with updated communication means
even though no changes have been made to the medical application
"part" of the device.
SUMMARY OF THE INVENTION
[0011] In view of the above disadvantages, the present invention
provides a method and device that avoids the need for further
medical product validation (e.g., by jurisdictional regulatory
bodies) when the communication part and/or software of a medical
device is changed, updated, or revised.
[0012] Likewise, the present invention provides a method and device
that avoids the need for further software validation (e.g., by
jurisdictional regulatory bodies) when the medical product (e.g.,
device) and/or communication part is changed, updated, or
revised.
[0013] The present invention further provides a method and device
that avoids the need for further communication part validation
(e.g., by standards setting bodies) when the medical product (e.g.,
device) and/or software of a medical device is changed, updated, or
revised.
[0014] The present invention further provides for clearly separate
critical medical application functionalities from the complex
communication software, hardware and/or firmware in order to obtain
maximum safety and reliability of the critical medical
application.
[0015] The present invention can be achieved by a device of the
aforementioned kind that comprises: [0016] a medical device part
comprising: [0017] a first processor and first storage means, and
[0018] a means for executing one or more medical related functions,
[0019] a communication device part comprising: [0020] a second
processor, second storage means, and [0021] a communication means,
[0022] wherein the medical device part and the communication device
part is connected allowing for exchange of data information
according to a predetermined protocol, the exchange of data
information is under the control of the medical device part and
where the functionalities of each device part otherwise is
separated.
[0023] Hereby, two physically and functionally separated
parts/units are obtained where one part is a medical device part
responsible for performing medically related actions, measurements,
calculations, exchange of data with other medical devices, etc. and
another part is a communication device part (just communication
part in the following) responsible for receiving and transmitting
information under the control of the medical device. The medical
device part controls the communication so the communication part
cannot interrupt or request service(s) from the medical device
part, thereby ensuring maximum safety and reliability of the
medical application(s).
[0024] In this way, when the parts (software, hardware, firmware,
etc.) of the communication device needs to be upgraded, the
integrity of the medical device part is preserved and the need for
any further medical product and software validation is avoided
thereby reducing time-to-market, expenses, etc.
[0025] Furthermore, when changes to the medical device part
hardware, software, and/or firmware are required then the scope of
medical product and software validation can be restricted to the
medical device part and need not involve the communication device
part thereby simplifying revisions tasks, etc.
[0026] According to a preferred embodiment, 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.
[0027] In this way, a simple protocol may handle and connect the
two asynchronous systems/parts of the medical device in a very
simple fashion and the communication part cannot interfere,
interrupt and/or transmit data/information to the medical part
without its permission.
[0028] In one embodiment, the medical device part further comprises
one or more of: [0029] a user interface, [0030] at least one
medical transducer, [0031] discrete and/or substantially
continuously body fluid analysis means, [0032] drug administration
means, and [0033] a short-range communication means for exchanging
data information with at least another medical device.
[0034] In this way, relevant medical functions, like blood
glucose/body fluid level measurement(s), drug or insulin
administration, may be integrated directly with the medical device,
so that a user will always have a medical function ready at hand
when using the medical device thereby avoiding the need for an
extra medical device. Additionally, the medical device may act as a
data collection/exchange device collecting/exchanging data with
other relevant medical devices using short-range communication.
[0035] In one embodiment, the at least another medical device is
selected from the group of: [0036] a drug administration device,
[0037] a body fluid analyser, [0038] an insulin administration
device, [0039] a blood glucose monitor (BGM), [0040] a continuous
blood glucose monitor (CGM), [0041] an inhaler, [0042] a tablet
dispenser, [0043] a lipid monitor, [0044] a pulse monitor, [0045] a
lancet device, [0046] a storage container, [0047] a balance, [0048]
and any other apparatus adapted to measure at least one
physiological parameter.
[0049] In one embodiment, the device further comprises a power
supply supplying the communication device part with power where the
power supply may be turned on and off under the control of the
medical device part.
[0050] In this way, power usage may be saved/minimized by turning
the communication part off when it is not used which is especially
important for portable devices usually having a limited power
supply.
[0051] In one embodiment, the communication means is adapted to
communicate according to the Bluetooth protocol.
[0052] Hereby, a very simple way of connecting to other devices
and/or networks are obtained.
[0053] In one embodiment, the communication means are adapted to
communicate information according to one or more of: [0054] Radio
frequency (RF) communication, [0055] Infrared (IR) communication,
[0056] HTTP (Hyper Text Transmission Protocol), [0057] SHTTP
(Secure Hyper Text Transmission Protocol), [0058] TCP/IP
(Transmission Control Protocol/Internet Protocol), [0059] PPP
(Point-to-Point), [0060] SSL (Secure Socket Layer), [0061] TLS
(Transport Layer Security), and [0062] IrDA,
[0063] In one embodiment, the communication means are adapted to
communicate with a wireless access point/a mobile terminal where
the access point/the terminal is adapted to communicate according
to one or more of: [0064] GSM (Global System for Mobile
communication), [0065] GPRS (General Packet Radio System), and
[0066] UMTS (Universal Mobile Telephone System).
[0067] In this way, a great level of mobility is assured for the
user of the medical device as well as being able to transmit
relevant data information.
[0068] In one embodiment, the communication device part is adapted
to exchange data information with a central server via a wireless
network access point.
[0069] The invention also relates to a system for supplying data
from a portable medical device to a third party, where the system
is adapted to:
[0070] automatically transmit data information from a portable
medical device to a central server for storage in at least one
database,
[0071] process said data information, in order to derive additional
information, and
[0072] automatically transmit at least a part of the additional
information to a predetermined third party.
[0073] In this way, a relative/relatives may obtain an ease at mind
since they know that they will receive information if anything is
wrong or may be potentially dangerous or they simply is
automatically updated on the user's current situation. This is
especially useful for relatives of elderly people, children, etc.
using a medical device. A medical professional may also receive
relevant information in this manner.
[0074] In one embodiment, the processing is done at said server
and/or at said medical device.
[0075] In one embodiment, the data information comprises
information representing one or more of: [0076] at least one blood
glucose value, [0077] at least one value representing a body fluid
level, [0078] at least one physiological parameter, [0079] amount
and/or type of administered medication, [0080] amount and/or type
of administered insulin, [0081] a trend of a glucose or body fluid
level, [0082] a prediction of a glucose or body fluid level, [0083]
timestamp in- or excluding date, [0084] amount of food, [0085]
measurement of physical activity, [0086] notification of
appointment, [0087] inventory logistics, and [0088] body
characteristics. [0089] warnings, and [0090] symptoms.
[0091] In one embodiment, the system is adapted to transmit data
information from a portable medical device to a central server
according to the Bluetooth protocol using a wireless access point
connected via a network to the central server.
[0092] In one embodiment, the third parties are one or more of:
[0093] at least one relative, [0094] at least one parent, and
[0095] at least one medical professional.
[0096] In one embodiment, the system is further adapted to exchange
information between the portable medical device and another medical
device in order to retrieve relevant data information.
[0097] The invention also relates to a system for collecting data
information from a number of portable devices, wherein the system
is adapted to: [0098] generate data information in a portable
device, the data information relating to a clinical trial of a
medical device and/or medical product, [0099] automatically sending
the data information from the portable device to a central server
for storage in a database, and [0100] process said data
information.
[0101] In this way, relevant information may then be automatically
transmitted directly to a relevant server for high-quality data
storage and collection since the actual obtained data is obtained
directly from the user/patient and transmitted e.g. for further
processing. This may reduce the cost and the time-to-market of a
new product since the data collection from many medical devices
taking part in the medical trial may be automated. Additionally,
the need for hand-written logs of the participants of the trial is
avoided thereby eliminating possible typos and avoiding the need
for manually inputting/scanning the logs into a system for storage
and processing.
[0102] The invention also relates to a method of communication of
medical data information between [0103] a medical device part
comprising: [0104] a first processor and first storage means, and
[0105] a means for executing one or more medical related functions,
and [0106] a communication device part comprising: [0107] a second
processor, second storage means, and [0108] a communication means,
[0109] wherein the medical device part and the communication device
part exchanges data information according to a predetermined
protocol, the exchange of data information is under the control of
the medical device part and where the functionalities of each
device part otherwise is separated.
[0110] In one embodiment, 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.
[0111] In one embodiment, the medical device part further comprises
one or more of:
a user interface, [0112] at least one medical transducer, [0113]
discrete and/or substantially continuously body fluid analysis
means, [0114] drug administration means, and [0115] a short-range
communication means for exchanging data information with at least
another medical device.
[0116] In one embodiment, the at least another medical device is
selected from the group of: [0117] a drug administration device,
[0118] a body fluid analyser, [0119] an insulin administration
device, [0120] a blood glucose monitor (BGM), [0121] a continuous
blood glucose monitor (CGM), [0122] an inhaler, [0123] a tablet
dispenser, [0124] a lipid monitor, [0125] a pulse monitor, [0126] a
lancet device, [0127] a storage container, [0128] a balance, and
[0129] any other apparatus adapted to measure at least one
physiological parameter.
[0130] In one embodiment, the method further comprises controlling
a power supply by the medical device part, where the power supply
supplies the communication device part with power.
[0131] In one embodiment, said communication means communicates
according to the Bluetooth protocol.
[0132] In one embodiment, said communication means communicates
information according to one or more of: [0133] Radio frequency
(RF) communication, [0134] Infrared (IR) communication, [0135] HTTP
(Hyper Text Transmission Protocol), [0136] SHTTP (Secure Hyper Text
Transmission Protocol), [0137] TCP/IP (Transmission Control
Protocol/Internet Protocol), [0138] PPP (Point-to-Point), [0139]
SSL (Secure Socket Layer), [0140] TLS (Transport Layer Security),
and [0141] IrDA,
[0142] In one embodiment, 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: [0143]
GSM (Global System for Mobile communication), [0144] GPRS (General
Packet Radio System), and [0145] UMTS (Universal Mobile Telephone
System).
[0146] In one embodiment, the communication device part exchanges
data information with a central server via a wireless network
access point.
[0147] The invention also relates to a method of supplying data
from a portable medical device to a third party, the method
comprising the steps of: [0148] automatically transmitting data
information from a portable medical device to a central server for
storage in at least one database, [0149] processing said data
information, in order to derive additional information, and [0150]
automatically transmitting at least a part of the additional
information to a predetermined third party.
[0151] In one embodiment, said processing is done at said server
and/or at said medical device.
[0152] In one embodiment, said data information comprises
information representing one or more of: [0153] at least one blood
glucose value, [0154] at least one value representing a body fluid
level, [0155] at least one physiological parameter, [0156] amount
and/or type of administered medication, [0157] amount and/or type
of administered insulin, [0158] a trend of a glucose or body fluid
level, [0159] a prediction of a glucose or body fluid level, [0160]
timestamp in- or excluding date, [0161] amount of food, [0162]
measurement of physical activity, [0163] notification of
appointment, [0164] inventory logistics, and [0165] body
characteristics. [0166] warnings, and [0167] symptoms.
[0168] In one embodiment, 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 using a wireless access point connected via a
network to the central server.
[0169] In one embodiment, said third parties are one or more of:
[0170] at least one relative, [0171] at least one parent, and
[0172] at least one medical professional.
[0173] In one embodiment, said method further comprises the step of
communicating between the portable medical device and another
medical device in order to retrieve relevant data information.
[0174] Finally, the invention also relates to a method of
collecting data information from a number of portable devices, the
method comprising the steps of: [0175] generating data information
in a portable device, the data information relating to a clinical
trial of a predetermined medical product and/or device, [0176]
automatically sending the data information from the portable device
to a central server for storage in a database, and [0177]
processing said data information.
[0178] The method and embodiments thereof correspond to the device
and embodiments thereof and have the same advantages for the same
reasons, and therefore will not be described again.
BRIEF DESCRIPTION OF THE DRAWINGS
[0179] FIG. 1 shows a schematic block diagram of a medical device
according to the present invention;
[0180] FIG. 2 shows a more detailed schematic block diagram of a
medical device comprising a Bluetooth communication device
part;
[0181] FIG. 3 illustrates the communication between a medical
device part and a Bluetooth communication device part;
[0182] FIGS. 4a and 4b illustrates examples of the communication
between a medical device and other devices according to the present
invention;
[0183] FIG. 5 illustrates the communication between a Bluetooth
communication device part and a central Internet server;
[0184] FIG. 6a illustrates the short-range communication between a
medical device according to the present invention and other medical
devices;
[0185] FIG. 6b illustrates communication between a medical device
according to the present invention and other medical devices;
[0186] FIGS. 7a-7c illustrate examples of various embodiments of
the short-range communication means.
DETAILED DESCRIPTION OF THE INVENTION
[0187] FIG. 1 shows a schematic block diagram of a medical device
according to the present invention. Shown is a medical device (100)
comprising an integrated medical device part (101) (denoted medical
part in the following) and an integrated communication device part
(102) (denoted communication part in the following).
[0188] The medical part (101) comprises one or more first
microprocessors/processing means (104), a first storage/storage
means/memory means (103), and means for providing/performing
medical related functionalities (106) like medically related
actions, measurements, calculations, etc.
[0189] The means for providing medical functionalities (106) may
e.g. comprise one or more of body fluid analyser means, drug
administration means, and/or short-range communication means for
communicating with at least another medical device and may operate
under the control of a separate processor (not shown), again being
controlled by the first processor (104), or under the control of
the first processor (104) directly.
[0190] The communication part (102) comprises one or more second
microprocessors/processing means (104'), a second storage/storage
means/memory means (103'), and communication means (105) for
communicating with and/or via other devices.
[0191] The medical part (101) and the communication part (102) are
connected allowing for exchange of date between them via a physical
interface (like a simple electrical connection) where the exchange
of data happens according to an interface layer (107) located in
and under the control of the processor (104). The interface layer
(107) comprises a suitable protocol and is under the complete
control of the processor (104) of the medical part (101). A
suitable protocol may e.g. be a protocol where the medical part
(101) operates as a master and the communication part (102)
operates as a slave as indicated by the one-way arrow (109) (even
though exchange of information is allowed in both directions). In
this way, two physically and functionally separated parts/units
(101; 102) are obtained as indicated by the line (108) where a
medical part (101) is responsible for performing medically related
actions, measurements, calculations, etc. and another part (102) is
a communication part responsible for receiving and transmitting
information under the control of the medical device. Hereby, the
critical medical application functionalities is clearly separated
from the complex communication software, hardware and/or firmware
giving maximum safety and reliability of the critical medical
application.
[0192] Preferably, the medical device (100) further comprises a
user interface (not shown) for receiving and/or presenting
information from/to a user of the medical device (100). The user
interface preferably comprises input means like buttons,
scroll-wheels or the like and output means like a display or
combined input-output means like a touch sensitive display like
already known in the art.
[0193] The first and second storage/memory means (103; 103') may
e.g. be a non-volatile memory, a volatile memory or a combination
of both. Examples are flash memory, RAM, ROM, EEPROM, magnetic
and/or optic storage means, etc.
[0194] The first (104) and second (104') processing
means/processors may comprise one or more general or special
purpose micro-processors or a mix hereof.
[0195] The communication means (105) preferably communicates
according to the Bluetooth standard/protocol. Alternatively,
communication via RF, IR, a wire/cable is used according to a
suitable protocol.
[0196] FIG. 2 shows a more detailed schematic block diagram of a
medical device comprising a Bluetooth communication part. Shown is
a medical part (101) and a communication part (102) corresponding
to the one shown in FIG. 1.
[0197] The communication part (102) comprises a Bluetooth
communication core and is adapted to communicate with external
devices according to the well-known Bluetooth protocol. The
Bluetooth core/the Bluetooth protocol stack comprises an Interface
Layer interfacing with the medical part (101). The Interface Layer
comprises in one embodiment an XML Glue-layer for generating,
providing, handling, etc. XML scripts thereby allowing for a
receiver to handle/execute these scripts directly. The protocol
stack of the communication part (102) also comprises the TCP/IP
(Transmission Control Protocol/Internet Protocol) and PPP
(Point-to-Point Protocol) protocols connected to the Interface
Layer via the XML Glue-layer. An RFComm (a serial emulation
protocol) manager is connected to the TCP/IP/PPP protocol manager.
The Bluetooth Core also comprises a Service Discovery Protocol
(SDP) manager that is responsible to determine which services are
available from Bluetooth enabled service servers like a PC or a
mobile telephone offering services like Internet and/or Network
connection, etc. or other types of services. The SDP manager is
also connected to the Interface Layer. Both the SDP and the RFComm
manager are connected to a L2CAP (Logical Link Control and Adaption
Protocol) manager (responsible for channel establishment) that is
connected to a Link Manager (LM) (responsible for link
establishment). The Bluetooth Core also comprises a Baseband and a
Bluetooth Radio specification responsible for the radio
communication according to the Bluetooth specification. Information
regarding the Bluetooth protocol may e.g. be obtained at
www.bluetooth.com incorporated herein by reference.
[0198] The communication steps between the medical device part
(101) and a communication part (102) using Bluetooth are explained
in greater detail in connection with FIG. 3.
[0199] The medical part (101) comprises a user interface for
receiving and/or presenting information from/to a user of the
medical device in the form of input means (202) like buttons,
scroll-wheels, etc. and output means like a display (201) or
combined input-output means like a touch sensitive display as
signified by the double arrow in parenthesis. The medical part
(101) also comprises a memory (103) for storing software, firmware,
relevant data/information, etc. The medical part also comprises a
real-time clock (RTS) (110) for enabling time- and date-stamps of
generated/provided information like time-stamping a glucose/body
fluid level measurement, a drug/insulin administration, etc.
[0200] Furthermore, the medical part (103) comprises one or more
medical function(s) (106) like described in connection with FIG. 1.
In this particular embodiment the medical device part (101)
comprises an integrated medical transducer or a medical
potentiostat like a body fluid analyser or more particularly a BGM
(blood glucose monitor), either a continuous (CGM) or a discreet
monitor. An additional medical function in this particular
embodiment is (e.g. very) short-range communication means (106') so
that the medical device part (101) may communicate with another
medical device (405), like a drug administration unit, an insulin
pen, an insulin doser, an inhaler, tablet dispenser, etc., in a
very simple manner thereby allowing exchange of relevant
information/data like type and amount/dose of administered
medication and a corresponding time/date-stamps. The information
may e.g. be generated during use of the other medical device(s) and
stored there until transferred to the medical part (101). These
short-range communication means may e.g. be optically communication
means like a Infrared transmitter/receiver pair (106') where
communication is initiated automatically when the additional
medical device is docked with or fitted to the medical
communication device (100) or simply is in close proximity.
Alternative short-range communications means are inductive or
electronic communications means that are explained in greater
detail in connection with FIGS. 7a-7c.
[0201] Alternatively, the communication part (102) may be used to
exchange information with other medical devices (405) thereby
avoiding the need for short-range communications means (106'),
however the short-range communications means (106') would typically
require less power and allows for simple, easy and transparent, for
the user, (if communication is initiated when docking the device)
exchange of information.
[0202] The medical device part (101) and communication part (102)
are separated like described before and signified by the line (108)
and connected allowing only for exchange of data under the strict
control (as signified by the one-way arrow (109)) of the medical
device part (101).
[0203] The medical device preferably also comprises a power supply
(203) to the communication part (102) that is controlled by the
medical device part (101). In this way, the communication part
(102) may be turned off in order to conserve power.
[0204] FIG. 3 illustrates the communication between a medical part
and a Bluetooth communication part. Shown are the communication
steps between the medical device part (101) and the communication
device part (102).
[0205] The medical device part (101) comprises an application
layer, a Medicom Layer (corresponds to (106) in FIGS. 1 and 2) and
an Interface Layer (corresponds to (107) in FIG. 1). The medical
device part (101) comprises the Bluetooth core shown and described
in connection with FIG. 2.
[0206] Communication may e.g. be initiated either on user request,
request by a medical application in the medical device part (101)
(e.g. on the basis of an obtained measurement from an integrated
medical transducer), an internal request by the medical device
(100), by docking another medical device with the medical device
(100) and/or using short-range communication means (106') with an
additional medical device like a doser, a CGM, inhaler, a BGM,
etc.
[0207] When a request for Bluetooth communication via the
communication device part (102) is generated, the medical part
(101) generates a Bluetooth power-up by activating the power supply
(203 in FIG. 2) if the communication part (102) is not already
powered. Then a request for a Bluetooth link to a relevant
information receiver is sent to the communication part (102). The
communication part (102) establishes a suitable link and returns an
acknowledgement after which the actual communication/transmission
of data may begin. If no establishment of a communication link is
possible or communication is impossible for another reason, the
relevant information is kept and may be tried transmitted at
another time, e.g. when the user uses the medical device (100) the
next time. Preferably, the communication part (102) is switched off
when it is determined that no communication is currently possible
in order to conserve power usage. A warning may be presented to the
user specifying that communication was not possible, but preferably
the communication takes place without the user's specific knowledge
and a warning may e.g. only be presented to the user if no data
communication was possible after a given number of tries or within
a given period of time dependent on the actual application of the
medical device (100).
[0208] After a Bluetooth link is successfully established, a first
frame comprising an amount of data/information is sent to the
communication part (102) where the frame is transmitted via the
Bluetooth radio transmitter. The communication part (102) reports
when the information has been transmitted, i.e. when a frame buffer
is empty. The steps `send frame` and `report empty buffer`
repeats/loops until the complete amount of information has been
sent, i.e. N frames of information has been transmitted via
Bluetooth radio communication. After the medical part (101)
receives a `frame buffer empty` and no further information has to
be sent, the medical part (101) may send a request for receipt of
the Bluetooth communication from the communication part (102). The
communication part (102) returns a receipt of the Bluetooth
communication with the relevant information receiver to the medical
device part (101), which then executes a power-down of the
communication part (102) in order to conserve power if no
additional information is to be exchanged.
[0209] The communication between the communication part (102) and a
relevant information receiver is explained in connection with FIGS.
4a, 4b and 5.
[0210] FIGS. 4a and 4b illustrates examples of the communication
between a medical device and other devices according to the present
invention.
[0211] FIG. 4a illustrates communication between a medical device
(100) and a mobile communications terminal (402) belonging to a
relevant third party via a mobile communications terminal/a
wireless access point (401), belonging to a user of the medical
device (100), to a network/the Internet. The medical device (100)
preferably communicates with the user terminal (401) according to
the Bluetooth protocol like described in connection with FIGS. 2
and 3, thereby establishing a Bluetooth communications link between
the communication device part of the medical device (100) and the
user's terminal (401). Alternatively, the communication between the
medical device (100) and the user's terminal (401) may be done via
IR communications means, a cable connecting them, other radio
frequency (RF) communications means, etc.
[0212] When the Bluetooth communications link is established
information may be transmitted to a terminal (402) of a relevant
third party using a GSM (Global System for Mobile communication),
UMTS (Universal Mobile Telephone System) and/or GPRS (General
Packet Radio System) communication network or another wireless
communication network, so that relevant information may be
exchanged between the user's terminal (401) (and thereby the
medical device (100)) and the terminal (402). The information may
e.g. be exchanged between the terminal (401) and the terminal (402)
using SMS (Short Message Service) or e-mail as a carrier (e.g.
sending SMS messages/e-mails alternating in both or in one
direction only) or alternatively, a two-way data communication
between the terminals (401; 402).
[0213] A relevant third party may e.g. be a medical professional, a
care-team, etc. and/or a relative of the user.
[0214] In this way, a medical professional may, e.g. automatically,
receive status reports of the user at a regular time interval or
when dangerous or potentially dangerous situation occurs or is
about to occur, e.g. when a critical body fluid/blood glucose level
being outside a predetermined interval has been determined and/or
estimated (for a future time) by the medical device (100).
Additionally, the professional may send relevant information, like
an updated medical regime and/or target body fluid/blood glucose
level interval, suggested action for a given situation (e.g.
administer X amounts of type Y medication) e.g. in response to
information/data received from the user's terminal (401)/the
medical device (100). This enables a very close and precise
monitoring of the user since data/information may be transmitted to
a professional regularly in an easy and transparent manner and the
data/information may be obtained directly by the medical device
(100) and/or other devices (BGM, CGM, insulin doser, drug
administration device, body fluid monitor, etc.) in communication
and/or integrated with the medical device (100).
[0215] A medical professional may also determine when the user has
to be called in for a consultation, check-up, etc. based on actual
received information instead of having regular consultations. In
this way, a user only needs to attend a consultation when there is
an actual need. Additionally, the professional is better prepared
since the relevant information is available to him in advance of an
consultation.
[0216] Another application of the present invention is that one or
more relatives of the user of the medical device (100)
automatically may receive a status report or information from the
medical device (100) via the terminal (401) regarding how the
user's situation is and/or going to be in the near future. The
transmitted information may e.g. contain time/date, type and/or
amount of administered medication, time/date and value of performed
measurement(s), compliance with a medical regime, etc. or simply
just a status e.g. `Status is ok`, `possible problem(s)`, `Serious
problems`, `X follows the medical regime fully`, `X has a BGL
within the target range`, etc.
[0217] In this way, a relative/relatives obtains an easy at mind
since they know that they will receive information if anything is
wrong or may be potentially dangerous or they simply is
automatically updated on the user's current situation. This is
especially useful for relatives of elderly people, children, etc.
using a medical device (100).
[0218] The medical device (100) may also receive and/or transmit
relevant data information with one or more external medical related
devices (405) as described later in greater detail in connection
with FIGS. 6a and 6b.
[0219] FIG. 4b illustrates communication between a medical device
(100) and a database server (403). The communication between the
medical device (100) and the terminal (401) is like described in
connection with FIG. 4a. Information/data received from the medical
device (100) is transmitted by the terminal (401) to a server (403)
preferably using the TCP/IP and PPP protocols and GPRS for
high-speed data communication. Alternatively, a GSM or a UMTS
network may be used. The server (403) may e.g. be an Internet
database server. The server (403) receives the relevant information
and stores it and determines what is to happen with the information
e.g. where it/a copy is to be transmitted and/or stored, if and how
it is to be processed, etc.
[0220] The server (403) may transmit the information to a number of
mobile terminals (403) and/or computers (404) e.g. as an SMS
message, an e-mail and/or in a suitable data format. Additionally,
a computer (404) and/or a terminal (402) may also connect to the
server (403) using standard browser software or WAP (Wireless
application Protocol) in order to access, retrieve, etc. the
relevant stored information, preferably, after specifying a valid
password and user-name. In this way, either a client, a relative to
a user and/or a medical professional may obtain easy access to the
stored historical medical data and/or derivations (e.g. processed)
thereof.
[0221] The secure socket layer (SSL)/transport layer security (TLS)
may also be used by the communication devices in this system (one
or more of terminal (401), terminal (402), the medical device
(100), the server (403), the computer (404)) in order to enhance
the security of the information. Bluetooth incorporates the
possibility of using built-in security by finding devices, pairing
devices, authentication, and encryption thereby enhancing the
security between the medical device (100) and the terminal
(401).
[0222] Applications of the embodiment shown in FIG. 4b corresponds
to the applications described above in connection with FIG. 4a.
[0223] Yet another application of the present invention is that it
may be used in connection of a clinical trial of a new medical
product (new/modified drug, new measurement device, new drug
administration device). Data collected by the medical device (100)
and other related medical devices (405) may then be automatically
transmitted directly to the relevant database server (403) for
high-quality data storage and collection since the actual obtained
data is obtained directly from the user/patient and transmitted
e.g. for further processing. This may reduce the cost and the
time-to-market of a new product since the data collection from many
medical devices taking part in the medical trial may be automated.
Additionally, the need for hand-written logs of the participants of
the trial is avoided thereby eliminating possible typos and
avoiding the need for manually inputting/scanning the logs into a
system for storage and processing.
[0224] Alternatively, the mobile terminal (401) and/or the mobile
terminal (402) may be an electronic device like a laptop, a PC, a
PDA, etc. equipped with communication and/or a gateway (e.g.
integrated, a network interface card (NIC), modem, etc.) to the
Internet, a cellular network like a GSM, GPRS, UMTS network, etc.
or another kind of communications network. The communication
between the device (401) and the medical device (100) may e.g. be
done via/according to the Bluetooth protocol or another RF
communication protocol, IrDA (Inrared Data Association) protocols,
a cable connection, etc.
[0225] One example of the use of the medical device (100) according
to the present invention will be illustrated by the following
use-case that describes a typical for a diabetic user equipped with
a medical device (100) according to the invention.
[0226] At 7.00. The user gets out of bed and takes his cap unit
with integrated BGM/medical device (100) and measures the glucose
content of his blood.
[0227] The medical device (100) records this event with a time
stamp and saves it in the memory/an electronic log book. Then the
medical device (100) searches for a wireless access point (401) to
the Internet, and if found, non-replicated data are transferred
from the electronic log book to a server.
[0228] The user then decides to take x units of actrapid (making
ready for his breakfast), he takes an insulin doser/insulin
administration device (405) which he has already dedicated to be
his actrapid doser and injects x units of actrapid. After the
injection the actrapid doser (405) is placed in, docked with,
brought in short-range communication range with, etc. the cap
unit/medical device (100).
[0229] The doser (405) will now make contact to the cap/medical
device (100) e.g. by means of an IR diode and an IR transistor to
transfer dose size, insulin type, relative time stamp and doser
status to the cap.
[0230] The cap/medical device (100) transfers setup data, if any,
to the doser (405). The cap can now calculate the absolute time of
this event and transfers it to the electronic log book.
[0231] The medical device (100) now searches for a wireless access
point (401) to the Internet, and if found, non-replicated data are
transferred from the electronic log book to a server (403).
[0232] At 8.00. The user has his breakfast.
[0233] At 9.00. The user arrives at his job, he decides (optionally
the medical device (100) reminds him) to make a control measurement
of the glucose content of his blood.
[0234] The medical device (100) records this event with a time
stamp and saves it in the electronic log-book. The medical device
(100) then searches for a wireless access point (401) to the
Internet, and if found, non-replicated data are transferred from
the electronic log-book to a server (403).
[0235] At 12.00. The user decides to measure the glucose content of
his blood again.
[0236] The medical device (100) records this event with a time
stamp and saves it in the electronic log-book. The medical device
(100) then searches for a wireless access point (401) to the
Internet, and if such an access point is found, non-replicated data
are transferred from the electronic log-book to a server (403).
[0237] He now decides to take x units of actrapid (making ready for
his lunch). After the injection he places his actrapid doser in the
cap/medical device (100).
[0238] The doser (405) will now make contact to the cap/medical
device (100) by means of an IR diode and an IR transistor to
transfer dose size, insulin type, relative time stamp and doser
status to the cap unit/medical device (100).
[0239] The cap/medical device (100) transfers setup data, if any,
to the doser (405). The cap/medical device (100) can now calculate
the absolute time of this event and transfers it to the electronic
log-book.
[0240] The medical device (100) then searches for a wireless access
point (401) to the Internet, and if such a point is found,
non-replicated data are transferred from the electronic log-book to
a server (403).
[0241] At 12.30. The user has lunch.
[0242] At 13.30. The user decides (optionally the medical device
(100) reminds him) to make a control measurement of the glucose
content of his blood.
[0243] The medical device (100) records this event with a time
stamp and saves it in the electronic log book. The medical device
(100) then searches for a wireless access point (401) to the
Internet, and if found, non-replicated data are transferred from
the electronic log book to a server (403).
[0244] At 17.00. The user decides to measure the glucose content of
his blood again.
[0245] The medical device (100) records this event with a time
stamp and saves it in the electronic log book. The medical device
(100) then searches for a wireless access point (401) to the
Internet, and if found, non-replicated data are transferred from
the electronic logbook to a server (403).
[0246] He now decides to take x units of actrapid (making ready for
his dinner). After the injection he places his actrapid doser (405)
in the cap/medical device (100).
[0247] The doser (405) will now make contact to the cap/medical
device (100) by means of an IR diode and an IR transistor to
transfer dose size, insulin type, relative time stamp and doser
status to the cap/medical device (100).
[0248] The cap/medical device (100) transfers setup data, if any to
the doser (405). The cap/medical device (100) can now calculate the
absolute time of this event and transfers it to the electronic log
book.
[0249] The medical device (100) then searches for a wireless access
point (401) to the Internet, and if is found, non-replicated data
are transferred from the electronic log book to a server (403).
[0250] At 18.00. The user has his dinner.
[0251] At 19.00. The user decides (optionally the medical device
(100) reminds him) to make a control measurement of the glucose
content of his blood.
[0252] The medical device (100) records this event with a time
stamp and saves it in the electronic log book. The medical device
(100) then searches for a wireless access point (401) to the
Internet, and if found, non-replicated data are transferred from
the electronic log book to a server (403).
[0253] At 23.00. The user decides to go to bed. He measures the
glucose content of his blood.
[0254] The medical device (100) records this event with a time
stamp and saves it in the electronic log-book. The medical device
(100) then searches for a wireless access point (401) to the
Internet, and if such a point is found, non-replicated data are
transferred from the electronic log-book to a server (403).
[0255] He now decides to take x units of insulatard (basic level
for the night). He takes another doser (405) which he has already
dedicated to be his insulatard doser and injects x units of
insulatard. After the injection he places his insulatard doser
(405) in/brings within short-range communication range of the
cap/medical device (100).
[0256] The doser (405) will now make contact to the cap/medical
device (100) by means of an IR diode and an IR transistor to
transfer dose size, insulin type, relative time stamp and doser
status to the cap/medical device (100).
[0257] The cap/medical device (100) transfers setup data, if any.
to the doser (405). The cap/medical device (100) can now calculate
the absolute time of this event and transfers it to the electronic
log book.
[0258] The medical device (100) then searches for a wireless access
point (401) to the Internet, and if found, non-replicated data are
transferred from the electronic log book to a server (403).
[0259] The user possibly checks whether the medical device (100)
contains non-replicated data, and if he finds that it is necessary
to connect to his server, he activates a user menu in the medical
device (100), which will immediately try to make contact to the
server (403).
[0260] The medical device (100) then searches for a wireless access
point (401) to the Internet, and if such an access point (401) is
found, non-replicated data are transferred from the electronic
log-book to a server (403).
[0261] FIG. 5 illustrates the communication between a Bluetooth
communication device part and a central Internet server. Shown is a
medical device (100) comprising a medical part (101) and a
communication part (102) like described earlier. The communication
part (102) comprises in this particular embodiment a Bluetooth
communication core. The two parts (101; 102) is connected via an
Interface Layer of each part so that the critical software, etc.
handling the medical related function(s) of the medical device
(100) is clearly separated. The medical related function(s) of the
medical device (100) is illustrated by an Application Layer. The
Interface Layer(s) connects and handles the two asynchronous
systems/parts (101; 102) using polling by the medical part (101),
assigned as master, of the communication part (102), assigned as a
slave. In this way, the communication part (102) may not interfere,
interrupt and/or transmit data/information to the medical part
(101).
[0262] A XML Medicom Layer in the medical part (101) is also shown
and is responsible for retrieving data/information to be
transmitted from the memory of the medical part (101), calculate a
check-sum (e.g. CRC) of the information and format it into a
suitable format e.g. a XML format where the information e.g. is
formatted into a number of frames each comprising a number of
fields.
[0263] An example of fields in a frame for a given format is:
TABLE-US-00001 Length Name of Data field (chars) Description
DeviceID 10 10 chars used for unique identification of the medical
device. DeviceVer 4 4 chars used for definition of an actual
XML-scheme used. DeviceTime 12 A timestamp (e.g. mmddyyhhmmss).
FrameCount 10 Indicates FRAME number. EventType 12 Indicates data
type, etc. Note 1 EventTime 12 A timestamp for a given event (e.g.
mmddyyhhmmss). EventSize 4 Value for event (e.g. amount of
administered medication or value for measured medical value.
CheckSum 8 A calculated check-sum value for the information
contained in the frame.
[0264] In one example/embodiment events being communicated may be
identified by:
[0265] Event_Type=INS-S-001 indicates an event where short-acting
insulin of type 1 was administered.
[0266] Event_Type=INS-S-XXX indicates an event where short-acting
insulin of type `xxx` was administered.
[0267] Event_Type=INS-L-001 indicates an event where long-acting
insulin of type 1 was administered.
[0268] Event_Type=INS-L-YYY indicates an event where long-acting
insulin of type `yyy` was administered.
[0269] Event_Type=INS-M-001 indicates an event where mix-acting
insulin of type 1 was administered.
[0270] Event_Type=INS-M-ZZZ indicates an event where mix-acting
insulin of type `zzz` was administered, etc.
[0271] Event_Type=BGM-mmol/l indicates an event where a body fluid
measurement/a blood glucose measurement (BGM) is done in
mmol/l.
[0272] Event_Type=BGM-mg/dl indicates an event where a body fluid
measurement/a blood glucose measurement (BGM) is done in mg/dl,
etc.
[0273] Event_Type=BGM-mmol/l-k indicates an event where a
calibration of a BGM/medical transducer is done in mmol/l.
[0274] Event_Type=BGM-mg/dl-k indicates an event where a
calibration of a BGM/medical transducer is done in mg/dl, etc.
[0275] Event_Type=STRIPCODE indicates an event where a new
strip-code, number identifier, bar-code, etc. for a given type of
medication is inputted into the medical device (100).
[0276] Each Event_Type has an associated value (if applicable)
specifying the actual value associated with the reported event. The
range and resolution depends on the given event, e.g. may the
values for a given type of medication/insulin cover the values
0-999 units (UI) with a resolution of 1/10, a new strip-code may
cover the values 0-999 with a resolution of 1, a calibration in
mg/dl may cover 0-999 with a resolution of 1, a calibration in
mmol/dl may cover 0-99 with a resolution of 1/10, a BGM/body fluid
measurement event in mg/dl may cover 0-999 with a resolution of 1,
a BGM/body fluid measurement event in mmol/dl may cover 0-99 with a
resolution of 1, etc.
[0277] The relevant information/frames is exchanged with the
Bluetooth core like described in connection with FIG. 3 and
transmitted to a Bluetooth supporting communication device/a mobile
terminal (401) according to the Bluetooth protocol.
[0278] The relevant information/frames is sent via the mobile
terminal (401) e.g. using GPRS, as described earlier, via a cell
phone provider (502) and the Internet/a network (503) to a database
server (403).
[0279] Preferably, a firewall (501) is connected between the
Internet/the network (503) and the database server (403) in order
to enhance the security of the server (403) by prohibiting
unauthorised communication. The server (403) may be accessed and
may process, transmit and/or receive information like described
earlier.
[0280] Preferably, the server site also comprises a HTTP server
connected between the firewall (501) and the database server (403)
for handling requests from browsers according to the HTTP
protocol.
[0281] The communication between the medical device (100) and the
database server (403) may use encryption of communication and the
web site (comprising the server(s)) may be secured using HTTPS/SSL
(or HTTPS/TLS) communication.
[0282] The communication between the medical device (100) and the
server (403) is preferably substantially a one-way communication
(from the device to the server) (although necessary handshakes,
receipts, etc. is transferred to the medical device (100)). If
applicable, information, e.g. updated data/information, like
recommended medical regimes, etc., is also transferred from the
server (403) to the medical device (100).
[0283] FIG. 6a illustrates the short-range communication between a
medical device according to the present invention and other medical
devices. Shown are a mobile medical device (100), two additional
medical devices that in this particular example are two drug
administration devices (405) containing different types of
medication, e.g. fast- and slow-acting insulin, and a CGM/biosensor
(601) like a glucose biosensor.
[0284] The dosers (405) comprises input means e.g. a turning wheel
(611) for adjusting, either electronically or manually, the
level/amount of medication to be administered, activation/input
means (616) for initiating the administration of medication and a
display (612) that shows the currently selected amount of
medication to be administered with text, icons, graphic
representations, etc. The doser (405) preferably has processing
means and storage facilities, like a CPU and RAM, for processing
and storing data, like the time, date and amount of medication of
the last couple of administrations. This information can be shown
in the display (612) e.g. on request.
[0285] The doser (405) further comprises a cartridge (613) that
contains the medication to be administered, and is fitted with a
needle (614) through which the medication is administered. The
doser (405) has a transparent window (615) so that the amount of
medication left in the cartridge (613) can readily be
identified.
[0286] Cartridges (613) may contain different types of insulin,
like fast and slow acting insulin, a mix-acting, etc., and the user
may insert/exchange a cartridge (613) of a given type when needed
and/or use multiple dosers (405) with different types of medication
(e.g. fast-acting and slow-acting insulin).
[0287] The dosers (405) are also provided with short-range
communications means (617) for receiving and transmitting
information and data representations from and to other devices as
will be described in the following. Alternatively, a doser (405)/an
additional medical device (405) may be provided with wireless
communications means/a wireless transceiver, as indicated by the
arrow in parenthesis, instead or in combination with the
short-range communications means (617).
[0288] The CGM (601) is a device that monitors/measures the blood
glucose level/concentration of a user continuously and comprises,
in this embodiment, a base unit and a glucose biosensor (603).
[0289] The CGM base unit is in this embodiment the medical device
(100) or more specifically the medical device part (101) being in
communication with the biosensor (603). Alternatively, a separate
CGM base unit may be provided that communicates with the medical
device (100).
[0290] The glucose biosensor (603) is mounted on an adhesive (602)
located on an appropriate part of the user's body like the stomach,
upper arm, etc. and is located subcutaneous, i.e. in the external
fat, in the user's body.
[0291] The biosensor (603) preferably comprises a potentiostat
where a fixed potential can be applied between two electrodes of
the biosensor hereby measuring the current that the work electrode
of the biosensor produces. The generated current is proportional to
the glucose concentration in the blood of the user.
[0292] The generated current is transmitted via a wire/cable or
wireless communication means like IR transceivers, RF transceivers,
etc. to the CGM base unit (100) for a translation/interpretation
from a continuous signal into a representation for later
processing. Preferably this translation is performed by a standard
A/D converter with a sampling rate which at least is faster than
the worst case change of the BGL so even the fastest change is
`captured` by the CGM (601)/CGM base unit (100). A sampling rate
may e.g. be once every couple of minutes.
[0293] Alternatively, the sampling takes place at the biosensor
(601) and only the sampled values are transmitted to the CGM base
unit (100).
[0294] The converted measurement/continuous values may be presented
to the user via displaying means (606) like a LCD display, etc.
[0295] The converted measurements are kept in a memory for later
retrieval, analysis, and etc. so a detailed history log of sampled
measurements may be obtained. This detailed history log may e.g. be
used to predict a trend for the BGL of a user thereby enhancing the
information value for the user.
[0296] In one embodiment the BGL measurement is converted into a
corresponding amount of insulin needed to bring the user into
compliance and displayed on the display (606).
[0297] The biosensor (603) is preferably calibrated on a regular
basis, e.g. each day, by external calibration e.g. by a traditional
blood glucose monitor (BGM) system, in order to ensure the best
accuracy. Typically the biosensor (603) will have to be replaced
after e.g. three days of use and be calibrated once each day.
[0298] Alternatively, the CGM may be embodied by other invasive,
semi-invasive or non-invasive systems.
[0299] In a preferred embodiment, the medical device (100) is a
protective cap unit comprising an integrated blood glucose monitor
(BGM), and one additional medical device (405) is an insulin
administration device arranged so that they automatically transmit,
via short-range communications means, relevant data information
between them when the devices are mutually positioned in a suitable
communication position, e.g. when the cap unit/the medical device
(100) is fitted onto, docked with/onto, clicked-on, screwed-into,
snapped-with, etc. with the additional medication device (405).
[0300] Alternatively, the additional medication device (405) may be
another type of drug administration device like a pen, syringe,
inhaler, tablet dispenser, etc. or in general any medication
administration device.
[0301] In this way, simplicity for the user is obtained, since the
devices automatically store and exchange data information as part
of the normal use.
[0302] The cap unit/medical device (100) can be fitted to an
additional medication device (405) so that one single compact unit
and protection of the additional medication device (405) is
obtained.
[0303] In this way, the user does not have to worry about
collecting data information in a separate log-book and
additionally, the data information may be collected in a single
apparatus for further processing, transmission and/or use. In this
way, a complete log-book is obtained in e.g. a single device, which
may be used by the user with the help of the devices to obtain
detailed information of trends, current and/or previous state(s),
re-occurring events, e.g. that adverse effects relating to the
self-treatment occur every Sunday by using/analysing for
behavioural and/or measured physiological patterns.
[0304] The short-range communications means (617) is preferably an
infrared (IR) communications means/transceiver providing IR
communication of data information between the medical device (100)
and the additional medication device (405).
[0305] Alternatively, the short-range communications means (617) is
an inductive means i.e. comprising inductive coils or the like in
each device.
[0306] As another alternative, the short-range communications (617)
is a electrical communications means, i.e. a simple switch
mechanism that may be used to transfer data information between
devices.
[0307] The embodiments of the short-range communication means
(617') are explained in greater detail in connection with FIGS.
7a-7c.
[0308] Additionally, the energy/power used for communication
between the apparatuses is minimized and/or reduced since only
(very) short-range communication needs to be used when the
cap/medical device (100) is fitted on, etc. to the additional
medication device (405). This is very important, especially for
portable apparatuses, since reduced energy consumption extends the
time between the need for charging a power source of the
apparatuses, like a battery, etc., prolongs the time where the
apparatuses may be used and/or extends the life-time of a
non-chargeable power source.
[0309] FIG. 6b illustrates communication between a medical device
according to the present invention and other medical devices. Shown
are a medical device (100) according to the present invention, a
CGM biosensor (601), a drug administration device (405), a
schematic representation of additional medical device(s) (405), and
a general base unit (620).
[0310] The general base unit (620) comprises a display (621), a
user interface and, preferably, wireless communication means/a
wireless transceiver for collecting and/or exchange relevant data
information from the other devices (601, 405). The information may
be viewed at the display (621) and stored at the base unit (620)
and be transmitted to the medical device (100) using short-range
communication means (617) when docking, fitting, clicking-on,
screw-into, snap-with, etc. the medical device (100) and the base
unit (620), as described earlier. Alternatively, the base unit
(620) and the medical device (100) is provided with wireless
communications means/a transceiver instead or in addition to the
short-range means (617), as indicated by the arrow in
parenthesis.
[0311] The additional medical device(s) (405) may comprise a tablet
dispenser, inhaler, a balance, body fluid measure device, drug
administration device or in general other diabetes relevant data
sources.
[0312] In this way, an easy way of obtaining additional information
from various other relevant devices is provided.
[0313] FIGS. 7a-7c illustrate examples of various embodiments of
the short-range communication means.
[0314] FIG. 7a illustrates an embodiment of the short-range
communication means adapted to communicate optically. Shown is an
example of an embodiment of infrared (IR) communication
means/transceivers. Shown are a receiver part (701) of the medical
device part and a transmitter part (702) of an additional medical
device. Alternatively, the medical device part and additional
medical device is each provided with a receiver (701) and a
transmitter (702) thereby enabling two-way communication.
[0315] FIG. 7b illustrates an embodiment of the short-range
communication means adapted to communicate via an electrical
switch. Shown is a cross-sectional view of an example of an
embodiment of simple mechanical/electrical communication means in
the form of switches. Shown are the communication switches of a
medical device part (701) and of an additional medical device
(702). The communications switches (703; 703') of the medical part
(701) have an electric connection between them when the medical
device part and additional device (701; 702) is not docked, fitted
onto, in an interrelated communication position, etc. When the two
devices (701; 702) are brought together then a first switch/switch
part (704) of the additional device (702) touches and moves the
first switch/switch part (703) of the medical device part (701)
thereby establishing an electronic connection between them (703,
704) and breaking the connection of switch/switch part (703) and
(703'). During the same movement a second switch/switch part (704')
of the additional device (702) touches the second switch/switch
part (703') of the medical device part (701) thereby establishing
an electronic connection. The breaking of the connection between
the first switch/switch part (703) and the second switch/switch
part (703') may determine when communication, transfer of
information, etc. may be initiated.
[0316] The first (704) and second switch/switch part (704') of the
second apparatus is preferably separated by an insulation layer
(705).
[0317] FIG. 7c illustrates an embodiment of the short-range
communication means adapted to communicate via inductive
communication. Shown is an example of an embodiment of simple
inductive communication means where current induced in a resonance
circuit is used to transfer information. Shown are a receiver part
(701) of a medical device part and a transmitter part (702) of an
additional medical device. Alternatively, the medical device part
and the additional medical device is each provided with a receiver
(701) and a transmitter (702) thereby enabling two-way
communication.
* * * * *
References