1. Field of the Invention
The present invention relates to tracking of disposable items in order to prevent their intentional or inadvertent reuse, their unauthorized use or use of disapproved, non-ingenious items. More particularly the present invention concerns monitoring and tracking of various medical disposable items, which are employed in various types of endoscopes for examination of body passages and cavities for abnormalities. Even more particularly, the present invention refers to monitoring and tracking of disposable items, which are used mostly in gastroenterology. The present invention is especially relevant to gastroenterology endoscopes provided with disposable covering sleeves, which protect the insertion tube from contamination. If the endoscope is used as a colonosocope, such a sleeve might at the same time assist, upon inflation, in propelling the endoscope within the colon.
Among disposable items, which are associated with such colonoscopes and should be monitored, one can mention single-use surgical tools, like biopsy forceps, snares, baskets etc., components of sheathing assemblies for single-use tools, internal working channels, e.g. single-lumen or multilumen tubings, caps for covering optical head, tubes for connecting with control unit and so on.
It should be borne in mind, however, that the present invention is not limited strictly to tracking disposable items referring to endoscopes used in gastroeneterology and that it is suitable for preventing reuse of disposable items associated with any other endoscopes or other medical devices as well.
2. Brief Description of the Related Art
The use of a disposable sleeve (also referred to as a sheath) to cover an endoscope is well known in the art. Flexible endoscopes, such as colonoscopes, are notoriously difficult to clean and disinfect thoroughly, leading to problems of cross-contamination between patients and between patients and staff. These problems can be partially avoided by covering the endoscope with a disposable sleeve, which is discarded after use. By using disposable sleeves it is possible to avoid labor and time consuming re-processing steps associated with disinfections of the colonoscope between adjacent colonsocopic examinations. By using disposable sleeves it is possible also to prevent cross-contamination. It can be readily appreciated that after the endoscopic procedure is finished, the disposable sleeve becomes a potential source for contamination and its reuse must be prevented.
Furthermore, endoscopes commonly have working channels, running from a proximal port outside the body to a distal port at the distal end of the endoscope. When the distal end of the endoscope is inserted into the body, the working channel may be used, inter alia, to pass a surgical instrument through to the distal end of the endoscope in order to perform a surgical procedure, such as a biopsy. Instruments that are used in this manner become contaminated with biological matter from inside the patient's body. As the instrument is withdrawn from the body, it spreads the contamination to the interior of the working channel and to the proximal port of the endoscope and eventually to the operator's hands. Therefore reuse of such instrument without disinfection/sterlization must be also prevented.
Embodiments of the present invention are particularly (although not exclusively) suitable for use with endoscopes, which are provided with sheathing systems for covering the outer surface of an endoscope, such as described in Eizenfeld (WO 2004/016299; PCT patent application PCT/IL2003/000661), which is incorporated herein by reference, or for use with the endoscopes provided with other sheathing systems known in the art. Such sheathing systems typically include disposable components, e.g. disposable dispenser assemblies for retaining the sleeve before use, disposable working channels or a disposable internal sleeve that fits inside the working channel of the endoscope and protects it from contamination.
It is known in the art also an apparatus for sheathing an endoscopic tool as described in Aizenfeld (WO 2005/023100; PCT patent application PCT/IL2004/000710), which is incorporated herein by reference.
The sheathing techniques employed in the apparatus described in this application are used to cover the endoscopic tool outside the body, after it has been withdrawn from the working channel. Optionally, the tool may subsequently be advanced again distally out of the sheath and into the working channel, and afterwards be retracted back proximally into the sheath. When the endoscopic procedure is finished, the tool can be disposed off and its sleeve must be disposed. The present invention is intended to prevent an inadvertent reuse of the sheath.
On the other hand it is well known in the art to use so called Radio Frequency Identification Devices or RFID for monitoring and tracking objects used in various applications, including medical devices.
An RFID system consists of two main components. The first main component is an antenna and a transceiver and a processing device, which sends RF energy and an interrogating signal (if necessary) to a transponder and then receives an RF response signal from the transponder and transfers it to a processing device. The second main component is a transponder, or tag, which is an integrated circuit containing RF circuitry programmed with information to be transmitted and an antenna.
RFID systems can be used for monitoring people, animals or physical objects used anywhere, including medical field.
In Butterfield (US Pub. No. 2004/0193453) is described an infusion data communication system, which employs RFID to ensure that the right medication is administered to the right patient through the right pump. This system is not designed for and is not capable of preventing reuse of a disposable item of an endoscope.
In WO2004008387 is disclosed a system for monitoring medical devices, such as pharmaceuticals and prescriptions. The system includes an RFID tag embedded in the cover of a container for the pharmaceutical or prescription and a reader that interrogates the tag and updates a database regarding the condition of the tag. The information in the tag can be revised by the reader or by an associated detector as the condition of the medical device changes. This system is not designed for and is not suitable for monitoring and tracking such disposable items, like flexible sheaths and sleeves employed in endoscopes in general and colonoscopes in particular.
The present invention seeks to provide a solution for preventing reuse of various disposable components employed in endoscopic apparatuses so as to ensure that only authorized disposable components are used. This is achieved by providing the disposable components with an RFID tag enabling their reliable monitoring and tracking and at the same time preventing their inadvertent reuse and preventing use of components fitted with inappropriate RFID tag or not having a tag at all.
The main object of the present invention is providing a new method and system for monitoring and tracking of various information identifying disposable components associated with endoscopic apparatuses.
Another object of the present invention is providing a new method and system for monitoring and tracking, which employs RFID tag attached to the disposable component of an endoscopic apparatus.
For a better understanding of the present invention as well of its benefits and advantages, reference will now be made to the following description of various exemplary embodiments taken in combination with the accompanying drawings.
With reference to
It is seen also in
One should bear also in mind that within the insertion tube are provided various devices, which are necessary for proper functioning of the endoscope. These devices are known per se. Among such devices one can mention vertebrae and strings, which can be manipulated by the operation handle, and a multilumen tubing with appropriate passages for supplying water, as required for irrigation, or vacuum, as required for suction.
The multilumen tubing also is provided with a dedicated passage for introducing surgical instruments into the colon as might be required during a colonoscopic procedure. Along the insertion tube might extend also a dedicated tube through which air is supplied as required for inflating the sleeve. The multilumen tubing extends through the endoscope and through the handle to a connector means 30, which provides flow communication between lumens of the multilumen tubing and tubes passing along the umbilical duct tubes and supplying air and vacuum to the insertion tube from the control unit and water from the flask.
With reference to
All above-mentioned disposable components (inflatable sleeve 22, dispenser 18, multilumen tubing, cap 32 and tubes passing along the umbilical duct) are manufactured from plastic material; they are cheap, disposable items, which are discarded at the end of the colonoscopic procedure after evacuation of the insertion tube from the colon. By virtue of this provision preparation of the endoscopic apparatus for a new endoscopic procedure is simple, convenient and fast. Furthermore, by virtue of the above-mentioned disposable components, contamination of the insertion tube from within the gastroenterological tract is prevented.
The present invention makes it possible to monitor, track and validate the information associated with at least one of the disposable items, employed in the endoscopic apparatus. This possibility is achieved by providing the endoscopic apparatus with a passive RFID tag deployed on the disposable item and with an interrogator/reader, which is capable upon receiving a signal from the processing device to transmit an interrogation signal to the tag so as to power it, interrogate and then, upon receiving modulated response signal from the tag, to read and process the information stored in the tag.
In the further disclosure the RFID tag comprises a passive transponder, which is an integrated circuit containing the RF circuitry along with a logic circuitry programmed therein with the data to be transmitted.
By the reader here is meant a device that supplies RF energy to the passive RFID tag and is capable to modify and/or extract the data contained in the modulated response signal. The reader also transmits this received data to a processing unit for validation. In some cases, in addition to supplying energy to the RFID tag, the reader is capable of interrogating the data. Therefore it will be referred-to further as interrogator/reader. It should be borne in mind however that within the scope of the present invention are also readers, which are not intended for interrogation.
Referring again to
The front-end interrogator/reader for the RFID tag 36 is not shown, however it similarly can be deployed either on the insertion tube in vicinity of the RFID tag or within the control unit. One skilled in the art should appreciate that, instead of separate interrogators/readers, a common interrogator/reader could be employed, which is capable to communicate with several RFID tags deployed on various disposable components. It should be also appreciated that the interrogator/reader irrespective of being a common one or a separate one would be electrically connected with the control unit by suitable wiring.
The RFID tag can be secured on the cap by different ways, e.g. by gluing to the cap's periphery or by molding within a dedicated recess 40 made on the cap's periphery or by any other suitable method.
As seen in
The response signal proceeds from the interrogator/reader to a data processing device 50, which is capable to process and to compare it with the data stored for the purpose of validation. The processing and comparison can be carried according to a method, which will be explained later on. The method allows comparing the information stored in the tag with a validation data stored within a dedicated database provided in the processor. It might be advantageous if the method employs a generator of random numbers for identification of disposable components to be interrogated. The processor and the database can be located either within the control unit 26 or within a dedicated separated item. It is also advantageous if the database with the validation data and/or the method would be accessible for update from the outside e.g. via the Internet, external computer, etc.
If upon validation procedure the information stored in the RFID tag does not match the data referring to an invalid disposable component (e.g. obsolete), the processor will generate a termination signal, which stops functioning of various components of the endoscopic apparatus. The endoscopic procedure will be resumed only after a new disposable component with a new RFID tag replaces the invalid disposable component and only after the information on the new RFID tag has been again verified against the validation data.
Referring now to
If the type or model received from the first validation module matches the non-valid data, in other words the disposable component in question is not permitted for use, or the data does not exist at all, the first validation module generates a System Disable signal 56 to terminate functioning of the system. Otherwise the information from the RFID tag proceeds for further validation.
It is shown in
If the type or model of the disposable component matches the valid model data the information from the RFID tag proceeds further to a second validation module, i.e. a serial number validation module 60. If the received serial number matches the non-valid serial number, or the data does not exist at all, the validation module 60 generates termination signal to disable the system. Otherwise the information from the RFID tag proceeds further to a further validation module 62, in which the expiration date is validated. The validation of the expiration date is carried out by comparing the expiration date programmed in the RFID tag with the current date, when the validation is carried out. There is provided also a supplemental validation module 64 for further validation of any other data, which may be programmed in the RFID tag.
If upon competition of the validation procedure all the data received from the RFID tag was found valid, a System Enable signal 66 is generated to enable the system. At the same time relevant information identifying the disposable component is displayed on the monitor and is stored in the processor for procedure record. This information enters also into a database with non-valid data in order to prevent a second use of the same disposable component.
It will thus be appreciated that the embodiments described above are cited by way of example, and that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and sub combinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art. Below is a partial list of such modifications.
So for example, the present invention would be suitable for use not only with colonoscopic apparatuses but with any other endoscopic apparatuses, e.g. gastroscopes, bronchoscopes, sigmoidoscopes, etc.
The present invention would be suitable for use with other disposable components, e.g. surgical tools, working channels etc.
The present invention would be suitable for use with disposable components, which are employed either in rigid or resilient endoscopes.
The present invention would be suitable for use with disposable components employed in endoscope, which is not provided with inflatable propelling sleeve.
It is not compulsory that the transceiver is able of interrogating the response signal.
The RFID tag can be reprogrammable so as to store new information.
Updating of valid/non-valid data may include not only addition of fresh information, but also changing of already stored information, e.g. change of designation of a model from valid to non-valid and vice versa.
Number | Date | Country | |
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60684153 | May 2005 | US |