Surgery – Diagnostic testing
Reexamination Certificate
1999-11-29
2003-04-01
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
C128S903000, C600S316000
Reexamination Certificate
active
06540672
ABSTRACT:
This invention comprises a medical system and a method of controlling the system for use by a patient for medical self treatment.
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.
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.
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 and No. 5,593,390. 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 device does not provide.
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.
Additionally, the functionality and the individual devices of an integral multi-functional device are very hard if not impossible to update without updating everything else.
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 cartridge, glucose tablets, waste containers, etc.
The object of the invention is to provide a method for effective monitoring of electronic data relevant to a plurality of apparatuses/units 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.
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.
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, processing and displaying information, an attempted data communication between said apparatuses is initiated on request, said communication being controlled by a functional master module, and designating said functional master module among at least two of said apparatuses.
The request can e.g. be initiated by a timer or other external events such as the patient performing an action. The invention provides the specialeffect 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.
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 and being designated as the functional master module, where the program information of highest priority may either be activated in or transferred to the designated functional master module. The unit of highest priority may very well be turned off by the user or even be broken, because the apparatuses may be adapted to communicate directly with each other 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.
Preferably a protocol where a number of potential master modules (unit of highest priority) is predefined. These predefined potential master modules are given a hierarchical priority and the potential master module with the highest priority among the activated and present potential master modules becomes the functional master module. This master module polls the other activated and present apparatuses for information.
In this way, when the user selects some of the apparatuses and takes them with him for a shorter or longer period of time, he still has a group/subset of apparatuses relevant to his self treatment which communicates/exchanges information with each other, where the designated functional master module is responsible for controlling the communication between the subset of apparatuses. The functional master module may receive and store/mirror all the information provided by/at the individual apparatuses for backup purposes, and for processing and collecting of information and an easier update with an overall master module (the one with the highest hierarchical priority), since it contains a mirror of all the information/data. Additionally the functional master module is responsible for controlling the transmission of relevant data, e.g. received from another apparatus, to the appropriate apparatus(es).
If the functional master module becomes unavailable, the individual apparatuses may just store the information locally until the master module becomes available or initiate the designation of a new functional master module, i.e. the one with the highest available priority.
U.S. Pat. No. 5,204,670 discloses a system for monitoring and identification which has a master module which transmits information collected from different sensors to a central system for further processing. It mentions the possibility of using software and hardware modules to implement a flexible system, but once the selection of modules has been made, the system and configuration are static.
WO 98/02086 discloses an inspecti
Aasmul Søren
Christensen Lars Hofmann
Iav Steffen
Poulsen Jens Ulrik
Rokkjaer Kent Halfdan
Began, Esq. Marc A.
Bosk, Esq. Richard W.
Green, Esq. Reza
McCrosky David J.
Novo Nordisk A/s
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