U.S. patent application number 10/342150 was filed with the patent office on 2004-02-26 for medical system and a method of controlling the system for use by a patient for medical self treatment.
Invention is credited to Aasmul, Soren, Christensen, Lars Hofmann, Lav, Steffen, Poulsen, Jens Ulrik, Rokkjaer, Kent Halfdan, Simonsen, Jan Henning.
Application Number | 20040039255 10/342150 |
Document ID | / |
Family ID | 26809167 |
Filed Date | 2004-02-26 |
United States Patent
Application |
20040039255 |
Kind Code |
A1 |
Simonsen, Jan Henning ; et
al. |
February 26, 2004 |
Medical system and a method of controlling the system for use by a
patient for medical self treatment
Abstract
This invention relates to an system for self treatment. The
system consists of several portable modules where one of the
modules is designated as a master module. The master module
controls, supervises and monitors all the mutual information and
data exchange between itself and the rest of the modules. The
modules can e.g. consist of a BGM, a doser and a storage container.
The modules may be able to generate and store data which is
transmitted to the master module if it is within range. If the
master module is not within range, the data is kept locally in the
module until the master module is available. The master module can
send the data to an external unit like a computer or database for
further processing. A physician or an expert care-team can access
the data in the database and give guidance to the patient on the
basis of these processed data. This processing could also be done
automatically by utilization of an expert system.
Inventors: |
Simonsen, Jan Henning;
(Struer, DK) ; Poulsen, Jens Ulrik; (Virum,
DK) ; Rokkjaer, Kent Halfdan; (Holstebro, DK)
; Christensen, Lars Hofmann; (Jyllinge, DK) ;
Aasmul, Soren; (Holte, DK) ; Lav, Steffen;
(Bronshoj, DK) |
Correspondence
Address: |
NOVO NORDISK PHARMACEUTICALS, INC
100 COLLEGE ROAD WEST
PRINCETON
NY
08540
US
|
Family ID: |
26809167 |
Appl. No.: |
10/342150 |
Filed: |
January 14, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10342150 |
Jan 14, 2003 |
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09450193 |
Nov 29, 1999 |
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6540672 |
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60111721 |
Dec 9, 1998 |
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Current U.S.
Class: |
600/300 |
Current CPC
Class: |
A61M 2205/18 20130101;
A61M 15/0065 20130101; A61M 2205/3584 20130101; A61M 5/178
20130101; G16H 10/60 20180101; G16H 20/17 20180101; A61M 2205/05
20130101; A61B 5/150305 20130101; A61B 5/157 20130101; A61J 1/03
20130101; A61M 2205/3561 20130101; A61M 15/0066 20140204; A61B
5/7264 20130101; A61B 2560/0443 20130101; A61B 2562/0219 20130101;
A61B 5/150267 20130101; A61B 5/150022 20130101; A61M 15/008
20140204; A61B 5/14532 20130101; A61M 2205/3592 20130101; A61M
2205/50 20130101; A61J 7/0454 20150501; A61M 2205/3553 20130101;
G16H 40/67 20180101; A61B 5/0022 20130101; A61M 2005/3126 20130101;
A61M 2205/502 20130101; A61M 2205/52 20130101; G16H 50/20 20180101;
Y10S 128/903 20130101; A61B 5/150358 20130101; A61M 5/31545
20130101; A61M 2205/3569 20130101; A61M 2230/201 20130101; A61B
2560/0406 20130101; A61B 5/150412 20130101; A61J 7/0409 20130101;
A61B 5/15113 20130101 |
Class at
Publication: |
600/300 |
International
Class: |
A61B 005/00 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 30, 1998 |
DK |
PA 1998 01578 |
Claims
1. A method of controlling data information between a plurality of
portable apparatuses for use by a patient for medical self
treatment, the treatment including a first operation and at least a
second operation, said portable apparatuses comprising a first
apparatus for performing the first operation, and at least a second
apparatus for performing the second operation, characterized in
that each apparatus belonging to the medical self treatment has
means for one or more of the following: storing, transmitting,
receiving and displaying information, and that an attempted data
communication between said apparatuses is initiated on request.
2. A method according to claim 1, characterized in that program
information having the highest priority with respect to control and
monitoring of mutual data communication between said apparatuses is
stored in one of said apparatuses.
3. A method according to claim 2, characterized in that said data
communication is performed as data polling.
4. A method according to claim 2 or 3, characterized in that said
program information of highest priority is stored in the apparatus
which the patient most often carries.
5. A method according to claims 1-4, characterized in that said
means are preadjusted to handle a common set of predetermined
measuring and information representations.
6. A method according to claim 5, characterized in that one or more
of said representations from said common set of measuring and
information representations are stored in said apparatuses and
communicated to said apparatus comprising program information of
highest priority when said apparatus comprising program information
is within range and ready for communication.
7. A method according to claim 5 or 6, characterized in that said
common set of measuring and information representations is stored
as one or more of the following representations: amount of
medication type of medication body fluid concentration time stamp
amount of food measurement of physical activity notification
inventory logistics body characteristics (e.g. weight, blood
pressure).
8. A method according to claim 7, characterized in that said common
set of measuring and information representations relates to one or
more of the following medications insulin growth hormones OHA (Oral
Hyperglychemical Agent) HRT (Hormone Replacement Therapy).
9. A method according to any one of the previous claims,
characterized in that said program information of highest priority
controls storing, transmitting, receiving and/or displaying
information from/to an external unit.
10. A method according to claim 9, characterized in that said
external unit is a computer.
11. A method according to claim 9, characterized in that said
external unit is a database.
12. A medical system for use by a patient for medical self
treatment, the treatment including a first operation and at least a
second operation, the system comprising a first apparatus for
performing the first operation and a second apparatus for
performing the second operation, characterized in that each
apparatus comprises means for storing and/or displaying
information, and comprising means for transmitting and receiving of
information so that each apparatus is able to exchange data with
any of the other apparatuses belonging to the self treatment.
13. A medical system according to claim 12, characterized in that
one of said apparatuses comprises program information having the
highest priority with respect to control and monitoring of mutual
data communication between said apparatuses.
14. A medical system according to claim 12, characterized in that
said apparatus comprising program information of highest priority
comprises means for storing, transmitting, receiving and/or
displaying transmitted information from the other apparatuses.
15. A medical system according to claims 12-14, characterized in
that said means are preadjusted to handle a common set of measuring
and information representations.
16. A medical system according to claim 15, characterized in that
said apparatuses comprise storing means for storing one or more
representations from said common set of measuring and information
representations when said apparatus comprising program information
of highest priority is out of range for communication.
17. A medical system according to claim 16, characterized in that
said common set of measuring and information representations
comprises one or more of the following representations: amount of
medication type of medication body fluid concentration time stamp
amount of food measurement of physical activity notification
inventory logistics body characteristics.
18. A medical system according to claim 17, characterized in that
said common set of measuring and information representations
relates to one or more of the following medication: insulin growth
hormones OHA (Oral Hyperglychemical Agent) HRT (Hormone Replacement
therapy).
19. A medical system according to claim 13 or 14, characterized in
that said apparatus comprising program information of highest
priority comprises means for storing, transmitting, receiving
and/or displaying information from/to an external unit.
20. A medical system according to claim 19, characterized in that
said external unit is a computer.
21. A medical system according to claim 20, characterized in that
said external unit is a database.
22. A medical system according to any one of the previous claims,
characterized in that said first and second apparatuses are
selected from the group of a lancet device a body fluid analyser a
drug administration system for administering, a predetermined dose
of medication to the patient a sensor for obtaining body
characteristics.
23. A medical system according to claim 17 or 22, characterized in
that said body fluid concentration is the blood glucose
concentration.
24. A medical system according to claim 22 or 23, characterized in
that said body fluid analyser is a blood glucose monitor.
25. A medical system according to claim 22, characterized in that
said body fluid analyser is a lipid monitor.
26. A medical system according to claim 22, characterized in that
said body characteristics is one or more of body weight and blood
pressure.
27. A medical system according to claim 22, characterized in that
said drug administration system is an insulin injecting device.
28. A medical system according to any one of claims 23-27,
characterized in that said apparatus has one or more storage
containers for storing a supply of one of more of the following: a
supply of lancets for the body fluid analyser or blood glucose
monitor a supply of test strips for the body fluid analyser or
blood glucose monitor an extra supply (carpoule) of insulin a
supply of needles.
29. A medical system according to claim 24, characterized in that
said blood glucose monitor comprises storing, transmitting and/or
displaying means for blood glucose level and/or time stamp.
30. A medical system according to claim 27, characterized in that
said insulin injecting device comprises storing, transmitting,
receiving and/or displaying means for a number of units of
medication, type of medication and/or time stamp.
31. A medical system according to claim 28, characterized in that
said one or more storage containers comprise storing, transmitting,
receiving and/or displaying means for inventory logistics.
32. A medical system according to any one of the previous claims,
characterized in that said system comprises means for presentation
of choices to the patient for a given situation, said presentation
being dependent on said patient's previous choices.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority under 35 U. S. C. 119 of
U.S. non provisional application No. 09/450,193 filed Nov. 29, 1999
and provisional application No. 60/111,721 filed Dec. 9, 1998 and
Danish Application No. PA 1998 01578 filed Nov. 30, 1998; the
contents of all three are fully incorporated herein by
reference.
[0002] This invention comprises a medical system and a method of
controlling the system for use by a patient for medical self
treatment.
[0003] For a number of years it has been possible to purchase
various devices for the treatment of diabetes, e.g. for injecting
insulin, for measuring blood sugar (such a device is referred to as
BGM in the following), for withdrawing blood samples, and other
accessories, the purpose of which is to enable the patient to nurse
his disease discretely and with a high standard of safety. Many
diabetic patients are elderly people who can easily get insecure
with respect to the medical equipment. It is very reassuring and
therefore also very important that the user can have feedback from
the system which confirms to the user that everything is OK right
from the technical function of the system to the patient's
physiological condition. This stretches out a psychological safety
net under the patient, which contributes to improving the quality
of life of patients having a disease such as diabetes.
[0004] Also many young people need to assure themselves that the
equipment is in order, i.e. calibrated, powered, updated and
otherwise ready to be operated.
[0005] One way of ensuring that you have all the things needed
ready at hand is to build several of the necessary devices together
into a single integral unit, see e.g. U.S. Pat. No. 5,536,249. This
is not an ideal solution since such a multi-functional device is
usually quite complex both with respect to manufacture and use.
People need to be familiar, secure and confident with the use of a
device for self-treatment which such an integral multi-functional
does not provide.
[0006] Another drawback of integrating several functions in one
apparatus is that owing to the commercial outlets the manufacturer
never integrates all possibilities, but just the most important
ones, in order for it to be relevant to a sufficiently large group
of users. The functions which are thus not integrated must be
provided by means of separate apparatuses typically of different
makes, which can easily create uncertainty as to whether the
apparatuses work correctly together.
[0007] According to the invention the individual devices may be
arranged for various respective functions relevant to the treatment
of e.g. diabetes, such as: a lancet device, a body fluid analyser,
one or more drug administration apparatuses for administering a
predetermined dose of medication to the patient. Further, there is
a number of other aids which the diabetic patient uses, e.g. test
strips for the blood analyser, needles, napkins for wiping off
blood, extra insulin carpoule, glucose tablets, waste containers,
etc.
[0008] The object of the invention is to provide a method for
effective monitoring of electronic data relevant to a plurality of
apparatuses which are used by a patient for self-treatment of a
disease, so that a greater level of safety, both functionally and
emotionally, and an effective feedback to the patient are
obtained.
[0009] This is achieved according to the invention in that the
individual apparatuses are provided with electronic communications
equipment so that the apparatuses--when in a state of mutual
communication--frequently exchange information between them. Hereby
a greater functional safety can be achieved and the total data
capacity of the system can be increased, so that the feedback
possibilities, e.g. of the system checking that every apparatus is
OK and set up properly and of the patient be given a number of
possible choices to choose from in a given situation, are
increased.
[0010] More particularly, the invention relates to a method of
controlling data information between a plurality of portable
apparatuses for use by a patient for medical self treatment, the
treatment including a first operation and at least a second
operation, said portable apparatuses comprising a first apparatus
for performing the first operation, and at least a second apparatus
for performing the second operation, wherein each apparatus
belonging to the medical self treatment has means for one or more
of the following: storing, transmitting, receiving and displaying
information, and an attempted data communication between said
apparatuses is initiated on request.
[0011] The request can e.g. be initiated by a timer or other
external events such as the patient performing an action.
[0012] The invention provides the further effect that a patient
need not bring along a large apparatus technically complicated in
use in order to treat his disease, but that the apparatus may be
divided into several smaller and simpler units capable of
communicating mutually. The individual units may optionally be
adapted to be interconnected mechanically, as disclosed in Danish
Patent Application No. PA199800714.
[0013] According to the invention, all apparatuses need not be
active for communication to be established between some of the
apparatuses. This requires that all the apparatuses are adapted to
a specific communications protocol, there being several options in
this respect. For example, one of the units may be provided with
program information of highest priority with respect to the control
and monitoring of data communication between the individual
apparatuses. The unit of highest priority may very well be turned
off, because the apparatuses may be adapted to communicate directly
and perform storage of information, which is subsequently
transmitted to the unit of highest priority when this is again in
communication with another of the apparatuses.
[0014] Alternatively, other communications protocols may be
implemented such as:
[0015] A protocol where a number of potential master modules (unit
of highest priority) is predefined. These predefined master modules
are given a hierarchical priority and the master module with the
highest priority among the activated and present master modules
becomes the functional master module. This master module polls the
other activated and present apparatuses for information.
[0016] A protocol where all the apparatuses can request
information/data exchange with one or more of the other possible
apparatuses (present and activated) on the basis of an event (e.g.
timer based, user operation, etc.). This is done by sending an
interrupt request (IRQ) to the other apparatuses which they can act
upon according to their situation. With this protocol there is not
a designated master module and every apparatus can
communicate/exchange data with one or more of the rest of the
apparatuses.
[0017] A protocol for a self-organizing network where every
apparatus retransmits all the received information until the
apparatus or apparatuses which the information was meant for
receive it. In this way every apparatus functions as a relay
station and a temporary store of transmitted information. This
structure is especially useful when the configuration of the
network is not known or when the configuration of the network
changes in an unpredictable manner. Another feature of a network of
this kind is that a maximal number of redundant transmission paths
with a buffer are created so that the system can transmit
information to apparatuses which were not available when the
information was transmitted.
[0018] A protocol where all the apparatuses transmits their
information without any supervision of any kind. The apparatuses
themselves have to decide what information is relevant for
them.
[0019] The unit of highest priority may be adapted to communicate
with a larger communication center which may contain a patient
database. Such further use of the invention is known e.g. from U.S.
Pat. No. 5,204,670, which, however, cannot offer the patient the
flexible and safe use of a set of different apparatuses according
to the invention which together are used in the treatment of a
disease.
[0020] The apparatuses according to the invention communicate
information such as: amount of medication, type of medication, the
concentration of relevant substances in the body e.g. body fluid
level/concentration, time stamp, amount of food (e.g. amount or
units of carbohydrate), measurement of physical activity,
notification (e.g. alert and warning) to the patient, body
characteristics (e.g. weight, blood pressure etc.) and inventory
logistics. This ensures that relevant information for e.g. a drug
administration system like a doser, i.e. number of units of
insulin, insulin type and time and date for administering, can
automatically be stored, displayed, received and transmitted to and
from all the relevant apparatuses. The doser could also receive
information regarding a predetermined number of units of insulin to
be administered and automatically set the amount of medication to
be administered by electromechanical means. In this way elderly and
handicapped people do not have to set the relevant amount of
medication themselves but just activate the doser.
[0021] It is especially useful to transmit the data from all
apparatuses to the apparatus containing the highest priority
program for safe keeping, calibration and updating of data and
possible transmission to e.g. an external unit like a PC or
database for further data acquisition, storage and processing.
[0022] In this way the patient, a physician or an expert care-team
can obtain the behavior over time of the patient, and a check for
compliance to a diet or treatment given to the patient by a
physician or an expert care-team can be made. This could also be
done automatically.
[0023] Additionally, it is also possible for the patient to
manually input information about the treatment. This information
may be historic information as well as information about a future
scheme (behavioral pattern) e.g. planned physical exercise,
administering of insulin, intake of food and other medications.
This information may be collected and thus serve as an electronic
diabetes diary or may be used to notify the patient through the
receiving means as to whether the planned actions are dangerous or
not.
[0024] It is evident that since the apparatuses are to be carried
by the patient, there is a potential lack of space for an advanced
input device e.g. a keyboard. Therefore, information which cannot
be input on a standardized form e.g. personal comments on the
treatment is typed into the apparatus by the patient using a simple
input device once and can subsequently be chosen from a list if
needed again.
[0025] The patient can further receive recommended amounts of
medication, exercise, food, etc. from a physician, an expert-team
or automatically.
[0026] The invention also relates to an apparatus for a medical
apparatus for use by a patient for medical self treatment, the
treatment including a first operation and at least a second
operation, the apparatus comprising a first apparatus for
performing the first operation and a second apparatus for
performing the second operation, wherein each apparatus comprises
means for storing and/or displaying information, and comprising
means for transmitting and receiving information so that each
apparatus is able to exchange data with any of the other
apparatuses belonging to the self treatment.
[0027] For a BGM according to an embodiment of the invention the
relevant information could be the time and date for measurement,
measured level/concentration of blood glucose which could be stored
or transmitted to another apparatus.
[0028] For a doser according to an embodiment of the invention the
relevant information could be the type of medication (e.g. long
acting or short acting insulin), number of units of insulin to be
administered and the time and date of the administering. This
information could both be set manually by the patient or remotely
by a physician, an expert care-team or automatically.
[0029] For a storage container according to an embodiment of the
invention the relevant information could be to keep track of the
contents of the container so that every time an object (e.g.
carpoule, needle, etc.) is used, the storage container will update
the inventory list. This list could be transferred to an unit of
highest priority immediately or later, which could in turn update
the patient's total holdings of objects, so that the system could
notify the patient when he should order a new stock of objects. The
ordering could also be done automatically by the system if the
inventory list is transferred to an external unit, which greatly
improves the confidence, comfort and safety of the patient.
[0030] In the following, a preferred embodiment according to the
invention is described in detail. This particular embodiment is
meant as one example only of the invention and should not as such
limit the scope of protection.
[0031] In the preferred embodiment a specific simple communication
protocol has been chosen to simplify the explanation of the
invention. In the chosen protocol a predefined apparatus is chosen
as the unit of highest priority (master module) which controls,
coordinates and monitors the mutual data communication between all
the apparatuses including itself The master module collects or
mirrors all the data stored in the other apparatuses. This
collected or mirrored data can then be redistributed to any of the
other apparatuses or an external unit (e.g. a personal computer or
database system ) for later retrieval and/or processing.
[0032] According to the invention the portable system can operate
even if the master module is not present, since all the relevant
apparatuses comprise internal storage means, so that they can store
the relevant information when it is obtained and transmit it when
they can reach the master module once again.
[0033] Preferably the information obtained is kept in the
apparatuses so that the patient on request always can be presented
with the latest measurements and/or information obtained or
received.
[0034] A person skilled in the art could easily implement other
communication protocols such as the ones described above.
[0035] In this embodiment a cap unit for a doser has been chosen as
the master module but any apparatus could have been chosen just as
easily. Preferably, the master module should be the apparatus that
the patient carries most often.
[0036] The invention will now be explained in detail with reference
to the FIGS. 1-9, in which
[0037] FIG. 1 shows a prior art doser with a conventional cap;
[0038] FIG. 2 shows a doser and a cap with a BGM, a lancet device
and a container for test strips attached;
[0039] FIG. 3 shows a cap with a BGM, a lancet device, a test strip
container attached and an additional container together with
useful/needed extras;
[0040] FIG. 4 shows a schematic functional diagram of a BGM
according to an embodiment of the invention;
[0041] FIG. 5 shows a schematic functional diagram of a doser
according to an embodiment of the invention;
[0042] FIG. 6 shows a schematic functional diagram of a unit of
highest priority according to an embodiment of the invention;
[0043] FIG. 7 shows a flowchart illustrating an apparatus
generating new data (e.g. a BGM) and how the apparatus behaves with
respect to data generation and communication;
[0044] FIG. 8 illustrates the general concept according to an
embodiment of the invention with respect to communication;
[0045] FIG. 9 illustrates two dosers and their communication
paths.
[0046] FIG. 1 shows a prior art doser 20 and a cap 10. The doser 20
comprises a turning wheel 21 for adjusting, either electronically
or manually, the level/amount of medication to be administered, and
a display 22 that shows the currently selected amount of medication
to be administered. The doser 20 has processing means and storage
facilities, like a CPU and RAM, for storing data, like the time,
date and amount of medication of the last couple of
administrations. This information can be shown in the display 22 at
request. The doser 20 further comprises a carpoule (not shown) that
contains the medication, and is fitted with a needle 27 through
which the medication is administered. The doser 20 has a
transparent window 25 so that the amount of medication left in the
carpoule can readily be identified. The cap 10 can be fitted to the
doser 20 so that one single compact unit and protection of the
doser 20, needle 27, etc. are obtained.
[0047] FIG. 2 shows a doser 20 with a cap 10 where the cap 10
functions as the master module. The doser 20 corresponds to the
doser 20 shown in FIG. 1 but with the additional feature of having
transmitting and receiving means 12. This enables the doser 20 to
transmit the stored data, i.e. the time, date, amount and type of
medication, to the master module 10 for storage and presentation
there via the master modules receiving means 12. Information of the
last couple of administrations (time, date, type and amount of
medication) can then easily be viewed on the display 11 on the
master module. If the master module 10 is not present or active,
the doser 20 will just store the information locally until the
master module 10 becomes available and the patient will be able to
view the information on the doser 20.
[0048] The doser 20 can also receive information via the receiving
means 12 from the master module 10. This information could for
instance be a predetermined amount of medication dictated remotely
by a physician, an expert care-team or automatically. The received
information is then used to automatically set the correct amount of
medication to be administered so that the patient does not have to
worry about that aspect, which is a great advantage especially if
the patient is elderly or handicapped.
[0049] Also shown is a BGM 30 which has means 34 for inserting test
strips 52 containing a sample of blood, for analysis by the BGM 30
by operating the buttons 36. The result of the analysis is stored
and either shown in the display 32 or transmitted to the master
module 10 via the transmitting means 12 for storage and
presentation on the larger display 11. The patient can at the same
time be presented with the last couple of results over a time
period.
[0050] A test strip container 50 is provided for the safe
keeping/storing of test strips 52 in the space 55 and can be
added/attached through locking means 31. With this addition, a test
strip 52 will always be available.
[0051] Further shown is a lancet device 40 removably attached to
the BGM 30 by the locking means 31. This lancet device 40 is used
by first loading the lancet device through the grip 44 and then
pressing the button 42, which releases the lancet, piercing the
skin, so that a blood sample can be obtained. With this inclusion,
the lancet device 40 is always at hand. This has the advantage that
a lancet device 40 is always available, for taking a blood sample
and applying it to a test strip 52. The test strip 52 can then be
inserted via the means 34 into the BGM 30, which will start
analysing the blood sample and, after completion of the analysis,
will show the result in the display 32. It is very useful to have
the BGM 30 and the lancet device 40 attached together in one
compact unit, since a BGM 30 would not normally be used without the
lancet device 40, thereby avoiding the fuss and uncertainty of
using multiple devices of perhaps different makes. On the other
hand, if the user already has a lancet device and is accustomed to
and familiar with the use of this particular lancet device, he can
still use this original lancet device and just use the remaining
items, which will be a compact set consisting of a doser 20 and a
BGM 30; The cost will be reduced hereby.
[0052] FIG. 3 shows the same units as are shown in FIG. 2, but
instead of a doser 20, there is now provided a container unit 60
with a relative large space 69 for storing the items needed
everyday for self-treatment. For a diabetic, e.g. such items could
be a napkin 61 for wiping excessive blood after a sample has been
taken, a waste container 62 for receiving used items, an extra
carpoule 63 which could contain another type of insulin, spare
needles 27 for the doser, spare lancets 65 for the lancet device
40, some glucose in the form of glucose tablets 64, etc. In some
situations and in certain forms of diabetes, the injection of
insulin may be replaced by administration of pills which may be
stored in the container, which thus replaces the doser described
previously. All these items, or the most relevant ones for a given
situation, could be held in the container space 69 for easy
retrieval, when needed.
[0053] The container unit 60 is provided with transmitting,
receiving and storage means 12. These means are used to communicate
an inventory list to the master module 10 on which the user can
view and update the inventory list via the buttons 36.
[0054] This list could be transferred to an external unit (e.g.
computer, laptop, palmtop, etc.) immediately or later, which could
update a list of the patient's total holdings of objects, so that
the system could notify the patient when he should order a new
stock of objects. The ordering could also be done automatically by
the system. In this way the patient will not have to be concerned
whether he has all the necessary objects for a future span of time
or not, which greatly improves the confidence and safety of the
patient.
[0055] FIG. 4 shows a schematic functional diagram of a BGM
according to an embodiment of the invention. The BGM consists of
the following functional blocks: `Controller`, `Receiving means`,
`Transmitting means`, `storage means`, `Displaying means`, `Input
means` and `Measuring Blood Glucose Level/Concentration`.
[0056] The central block is the functional block `Controller` which
coordinates, monitors and controls the tasks of all the other
functional blocks. The `Receiving means` and `Transmitting means`
is responsible for receiving and transmitting of information data,
respectively. The block `Measuring Blood Glucose
Level/Concentration` performs the measurement of the blood glucose
level/concentration on e.g. a test strip, containing a blood
sample. The `Displaying means` can display relevant information to
the patient e.g. the result of a measurement and a time stamp
containing the time and date of the measurement. The result of the
measurement can be stored in the `storage means` for later
retrieval and further be sent to another apparatus (e.g. the master
module) through the `Transmitting means`. All these tasks take
place under the supervision and coordination of the `Controller`
block.
[0057] The BGM according to an embodiment of the invention could
thus be operated in the following way. When a request for a
measurement of the blood glucose level/concentration is made either
by the patient through the `Input means` or by another apparatus
through the `Receiving means`, the controller receives the request
and activates the `Measuring Blood Glucose Level/Concentration`
block, which initiates and performs the measurement of the blood
glucose level when the patient inserts a test strip with a sample
of blood into a slot on the apparatus. Previously a calibration of
the measurement equipment could be made by insertion of a
calibration test-strip. The result and a time stamp of the
measurement are then transferred to the storage means, and the
controller can send the result via the transmitting means to
another device e.g. the master module if it is within range.
[0058] All these functional blocks could be implemented by prior
art/standard components. The block labeled `Controller` could e.g.
be implemented by any type of CPU, micro processor, micro
controller, EEPROM or ROM containing software, firmware, etc. The
functional block `storage means` could be standard RAM.
[0059] The BGM is only an example of an apparatus that could be
used according to this invention. Any other body fluid analyser
e.g. lipid monitor or the like could be used.
[0060] FIG. 5 shows a schematic functional diagram of a doser
according to an embodiment of the invention. The doser consists of
the following functional blocks: `Controller`, `Receiving means`,
`Transmitting means`, `storage means`, `Displaying means`, `Input
means` and `Administering a dose of Medication`. These functional
blocks correspond to the blocks previously described for the BGM in
FIG. 4, except for the block `Administering a dose of Medication`,
and will therefore not be explained once more.
[0061] The functional block `Administering a dose of Medication`
administers a dose of medication e.g. insulin. The amount of
medication could be set by the patient through the `Input means` or
be set electromechanically by the `Controller` block according to
information received via the `Receiving means`. This information
could be prescribed by a physician, by an expert care-team or
automatically, so that elderly or handicapped people would only
have to activate the doser through the input means to be
administered a dose of medication. After the activation of the
doser, information e.g. type of medication (e.g. long acting or
short acting insulin), amount of medication and the corresponding
time stamp (date and time) is stored in the `storage means` and
transmitted to an apparatus (preferably the master module) if it is
within range.
[0062] Other devices than an insulin doser could be used in
accordance with the invention. These could e.g. be devices that
administer growth hormones, etc. One could also have an device that
obtains information of orally obtained medication like OHA (Oral
Hyperglychemical Agent). This would, however, require the user to
manually input the type and amount of medication, which could be
done by choosing icons, selecting an object in a predetermined list
or typing the information by alphanumeric keys. Preferably, a
predetermined list would require the user to just enter (e.g. by
icons or alphanumeric keys) the relevant text once and then later
just present the user with the already entered text and only ask
for the amount and type (which could also be pre-entered in the
same fashion).
[0063] FIG. 6 shows a schematic functional diagram of a master
module according to an embodiment of the invention. The master
module consists of the following functional blocks: `Controller`,
`Receiving means`, `Transmitting means`, `Storage means`,
`Displaying means`, `Input means` and `External function`. These
functional blocks correspond to the blocks previously described
with reference to FIGS. 4 and 5, except for the block `External
function`, and will therefore not be explained once more.
[0064] The master module is the module responsible for the
coordination, supervision and control of the information and data
exchange between itself and all the other present and activated
apparatuses. These apparatuses identify themselves to the master
module when they are within range so that the master module always
knows which apparatuses are present and activated. The master
module also receives and stores all the information and data
generated in the individual apparatuses for later retrieval and/or
transmission to an external unit (e.g. computer or database) for
further storage and processing. The relevant information can be
displayed on the larger display of the master module and be acted
upon by the patient.
[0065] Some of the tasks of the master module could be implemented
in the external unit and vice versa.
[0066] The master module could be any of the apparatuses as
represented by the functional block `External function` in FIG. 6,
but is in this embodiment the cap unit 10 shown in FIGS. 2-3, and
has as such no external function. Other functions may readily be
implemented in this block.
[0067] FIG. 7 shows a flowchart illustrating an apparatus
generating new data (e.g. a BGM) and how the apparatus behaves with
respect to data generation and communication.
[0068] In idle mode the apparatus determines whether or not data
generation is requested. If this is the case (e.g., if the user has
inserted a blood glucose measuring strip into the apparatus), the
data generation block assumes priority and completes the procedures
associated with the data generation (e.g. measurement of the blood
glucose concentration). After completion of the data generation the
data is stored in the internal memory of the apparatus.
[0069] After completion of the data generation or after
determination that data generation was not requested, the apparatus
determines whether or not communication is requested--either by the
apparatus itself (several criteria can issue the communication
request e.g. a timing event, a user interface event, etc.) or by an
apparatus different from the apparatus itself (e.g. a request from
the master module). If communication is not requested, the
apparatus resumes its idle mode. If communication is requested, the
apparatus sends out a request for the other apparatuses within its
range to identify themselves to the apparatus--enabling it to
establish the present communication environment. Based on the
established communication environment the apparatus identifies
whether or not the master module is within range of the apparatus.
If the master module is not within range of the apparatus, the
communication is terminated and the apparatus returns to its idle
mode. If however, the master module is within range of the
apparatus, the apparatus sets up a connection with the master
module and identifies itself to the master module. After exchange
of apparatus identification it is established whether the master
module is updated with respect to the internal data contained in
the internal memory of the apparatus or not. If the master module
is updated, the data is not transmitted once more. If, however, the
master is not updated regarding the internal data of the apparatus,
the data necessary to update the master is transmitted from the
apparatus to the master module. After completion of the data
transmission it is likewise established if the master module
contains data relevant to the apparatus which is not present in the
apparatus. If this is the case, the master module transmits the
relevant data to the receiving means of the apparatus after which
the data is stored in the internal memory of the apparatus. After
storage of the received data or if no data transmission was
necessary, the apparatus returns to its idle mode and the circle is
completed.
[0070] FIG. 8 illustrates the general concept according to an
embodiment of the invention with respect to communication. Here the
system consists of the portable units: a master module, a doser, a
BGM, the remote units: Remote Receiver, Physician/Expert Care-team
and Stationary Unit and a Communication Interface between them.
[0071] The master module controls the information and data flow
between itself and the other apparatuses and collects relevant data
and information from all the other portable units. This data and
information could e.g. be amount of medication, type of medication,
body fluid concentration, time stamp (date and time) and inventory
logistics. Additionally, the patient can manually input information
and data related to amount of food, measurement of physical
activity in the way described above. This data and information can
then be transmitted via a communication interface (which may be
built into the master module) to external units like a database for
data acquisition of the patient's data over time or a computer
which the patient uses to be kept informed about his treatment.
Alternatively, all the apparatuses could communicate to all the
others.
[0072] The information in the database can be accessed by a
physician or an expert care-team who could easily and quickly check
for compliance to e.g. a diet or treatment course/progress. The
physician or expert care-team could send a notification (e.g. alert
or warning) to the patient if the data shows an inappropriate
future treatment span. The patient could also be notified of a
future appointment in this way or receive guidance.
[0073] The system also makes it possible for the physician or
expert care-team to give the patient a number of choices to a given
situation. The patient could e.g. be informed that the blood
glucose level/concentration is quite high and the patient could be
presented with the choices of either exercising for given amount of
time or administering a given amount of a given type of medication.
The possibility of choices makes the patient feet more in control
of the treatment and enhances the therapeutic value of the
treatment. This could also be done automatically be the
systems.
[0074] Many of the above tasks could be fully automated by
utilization of an expert system which is fully updated with the
patient's data and condition and has access to the patient's
behavior over time.
[0075] FIG. 9 illustrates two dosers and their communication paths
The dosers are identical for the typical patient, one doser
containing fast acting insulin, the other doser containing slow
acting insulin. The dosers comprise a microcontroller and memory as
shown in FIG. 5. The dosers are capable of holding information
about the insulin type they contain. This information may either be
obtained by the doser reading e.g. a bar code on the carpoule or
the information may be input from the patient. Thus the features of
the doser enable it to log information about the insulin treatment
(insulin type size of the dose and time stamp)
[0076] One doser is equipped with a cap unit 73 which acts as a
storage container for an extra insulin carpoule, needles etc. The
storage container is capable of keeping track of the contents of
the container which enables it to keep the inventory list updated,
as described earlier in the present document.
[0077] The other doser is equipped with a cap unit 74 comprising a
BGM, a microcontroller and memory . This enables the cap unit 74 to
log information about the blood glucose concentration (with time
stamp).
[0078] All the dosers 71, 72 and the cap units 73, 74 comprise an
interface which enables them to exchange data. In the present
example the master device is the BGM cap unit 74, which, in
addition to the local interface, comprises an interface that
enables it to communicate with external units through standard
communication links (RS-232, Wireless local area network, phone,
cellular phone, pager, satellite link, etc.). Through these
communication links, the patient's treatment data can be
transferred to the patient's own computer 80 or via e.g. the
telephone system 75 to the patient's electronic medical record on a
central server 76. From here, the treatment data may be accessed by
the patient e.g. from a web page, using a stationary computer 77, a
laptop computer 78, a handheld computer 79, etc. Apart from the
patient, the care team can access the patient's treatment data. The
patient's master unit 74 can receive data from the central server
76, in addition to transmitting data.
[0079] This system has the advantage that the system can function
on 3 levels:
[0080] 1) If one of the patient's devices 71, 72, 73, 74 is
isolated by means of communication, it will log data.
[0081] 2) When the patient's devices 71, 72, 73, 74 are within
communication distance, the treatment data are transferred to the
master unit 74, enabling it to supply the patient with a overview
of his treatment as well as warnings or alarms if data shows that a
potential dangerous situation may occur.
[0082] 3) When the master device 74 is connected to the central
server 76 through standard communication links, the treatment data
is transferred to the patient's electronic medical record. This
enables an expert system on the central server to notify the care
team if needed. The care team may send information back to the user
or send help if needed.
[0083] Furthermore it is well known that due to the safety of the
patient, the development of a medical device is a time consuming
task. Using a local communication form between the patient's
devices 71, 72, 73, 74 has the advantage that only the master
device 74 need to be redesigned to keep up with the continuous
change in the standard communication links.
* * * * *