Medical device

Details Medical device Medical device

2001-02-07

2003-09-30

Lee, Michael G. (Department: 2876)

Registers

Systems controlled by data bearing records

C235S449000, C235S451000, C235S382000

Reexamination Certificate

active

06626355

ABSTRACT:

FIELD OF THE INVENTION
The invention relates to a medical device with a medical apparatus comprising an accessory port, and with at least one accessory piece comprising a connection element being complementary to said accessory port, the connection element carrying identification information, with said accessory piece connected to the device said identification information being readable by a readout unit located at said accessory port, read and de-coded identification information being compared to preset identification information stored in said readout unit, and the medical device being activated if the identification information match the preset identification information, and being blocked if the identification information do not match. Medical devices in the meaning of the invention are in particular sucking and/or rinsing pumps or gas supply systems for dialysis, arthroscopy, hyteroscopy, cystoscopy, laparoscopy and breathing technologies. An accessory piece typically is a hose set and/or a filter, for instance a pump hose set for roller pumps, gas hose sets, if applicable with a sterile filter and/or a heating device for a medium passing through, for the connection of the medical device to a medical instrument for said applications. A number of functional accessory pieces may be provided for a device, and it is understood that when using one single device or one single device type, sufficient compatibility between the respective connection element and the accessory port exists.
BACKGROUND OF THE INVENTION
A medical device of the type mentioned above is known as an internal state of the art. Herein, identification information are stored as a bar code and are read out by means of a bar code reader. The structure of bar codes is well known and standardized, so that any user can read a bar code. Insofar a usual bar code does not provide coded identification information; the identification information is available like text in the clear.
Normally, accessory pieces are diposable articles, which are suitable for a limited number of applications only. Typically, many accessory pieces, such as hose sets, are; once-only articles, for sterility reasons. There are therefore general problems for medical devices in that accessory pieces could inadmissibly be re-used, for cost reasons. Another problem is that there are suppliers of accessory pieces, and only of accessory pieces, whose products do not meet) all requirements, in technical or in medical respect. This will lead to substantial health risks for patients, which is of course very disturbing.
The above problems have been solved by authorized manufacturers of accessory pieces in various ways. When using a bar code, the bar code scanner reads the bar code and verifies whether the read bar code corresponds to a reference list of allowed bar codes. If yes, an activation of the device is possible; if not, there is no activation possible. This internal state of the art is a progress for the solution of the above problems, however it is relatively easy to circumvent the thus established safety function. An imitator only needs to read out the bar code and apply it on his products of minor quality.
A different approach to solve the mentioned problems is a complicated shaping of accessory port and connection element. This will make unauthorized imitations more difficult to produce, will however also lead to substantial higher costs for authorized manufacturers, with the consequence of higher prices for the accessory pieces. Finally, no advantage will be achieved, since an unauthorized imitator can nevertheless work on relatively low cost by medically concerning savings in the fields of the technical properties or for instance of sterility.
Further problems in conjunction with accessory pieces will be the often relatively limited durability and the therewith connected expiry dates and the possible mis-use by exceeding the maximum allowable application cycles (typically 1 for hose sets). This is in no way solved by the measures described above.
SUMMARY OF THE INVENTION
The invention is therefore based on the technical object to provide a medical device excluding dangers to patients by using inadmissible accessory pieces. Another embodiment of the invention is based on the further technical object to exclude dangers to patients by inadmissible multiple uses of accessory pieces or by using accessory pieces the expiry dates of which have been exceeded.
For achieving the first object, the invention provides a medical device with a medical apparatus comprising an accessory port, and with at least one accessory piece comprising a connection element being complementary to the accessory port, the connection element including a storage unit where coded identification information, with the accessory piece connected to the device coded or un-coded identification information being readable by means of a readout unit disposed in the section of the accessory port and, in the case of reading of coded identification information, being de-codable, read and de-coded identification information being compared to identification information stored in said readout unit, and the medical device being activated when the identification information at least partly match the desired identification information, and being blocked when the identification information do not match, and coded identification information being de-codable by means of a proprietary key code. It is understood, when reading out as un-coded identification information, that then a de-coding has to be performed beforehand in the storage unit. As a storage unit, any device for fixing information is designated. These are in particular electronic, magnetic, and optical storage media. For the purpose of the invention, a storage unit may include components in addition to the basic memory, as for instance processors and/or communication assemblies. A readout unit typically comprises, in addition to the communication assemblies required for readout, also electronic means for processing the read-out identification information, in particular for comparing to the preset (valid) identification information and for controlling the device according to the result of such comparison. Identification information includes sequences of characters processed according to the structure of the basic memory, these sequences being characteristic for a certain type of an accessory piece and possibly also for an individual accessory piece, and being specified by an authorized manufacturer. In case the identification information is individually characterizing, it is recommended to subdivide the identification information into accessory piece type information and individual piece information. Then the comparison to the preset (valid) identification information will typically be performed with the accessory piece type information only. The authorized manufacturer will then also provide for the integration of respective identification information or accessory piece type information as preset (valid) identification information in the readout unit. Coded identification information differs from un-coded identification information in that the un-coded identification information has been transformed by means of the key code. On a binary basis, a coding may for instance in the simplest case be implemented by shifting the bit orders by means of a shift register function on the basis of, e.g. ASCII, characters, for instance mathematical operations with regard to the alphanumerical (alphabetical) order may be needed. Many various coding techniques are well known to the man skilled in the art and need not be explained here in more detail. Coded identification information in the meaning of the invention does however also exist, if the identification information are per se stored in clear in a storage unit, readout of the storage unit being however only possible by means of a key code or not being re-readable (so-called hidden information).
It is achieved by the invention, based on the identification information being present in the storage

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