HK1192131A - Controlled-use imaging system - Google Patents

Description

Controlled use imaging system

Technical Field

The present invention relates to the technical field of instruments for medical purposes, which can access, illuminate and examine the interior of the body in a general sense, such as a lumen or a tube.

More specifically, the present invention relates to single-use medical endoscopes, which are suitable for superficial or deep examination of hollow organs, or natural or artificial lumens or tubes in the human body for therapeutic, surgical or diagnostic purposes.

For example, the endoscope of the present invention may be used in the following fields: the urethra, the gastrointestinal tract, the respiratory system, the cardiovascular system, the trachea, the sinus cavity, the female reproductive system, the abdominal cavity, or any other part of the human body that can be detected via natural or artificial entry.

Background

In the above-mentioned technical field, there are different types of endoscopes, which are suitable for accessible organs to be observed. In general, endoscopes comprise an insertion tube with a more or less flexible nature, having a proximal end for connection to an actuation support base which makes it possible to guide and manipulate the tube within an insertion channel. The endoscope also has a viewing system, typically optical, such as a camera associated with a light source, so that the distal end of the insertion tube can illuminate and examine organs, lumens or ducts of the human body.

In general, endoscopes are relatively complex electromechanical devices that have a relatively high cost. Given its price, endoscopes are reused many times after being cleaned or decontaminated in use.

However, over the years, due to the reduced cost of electronic components, it has been found possible to make non-reusable detachable medical devices that are attached to a reusable connection support base. Moreover, making medical devices that are not reusable, i.e., single use devices, allows for the use of materials that do not need to withstand cleaning, sterilization, or decontamination processes. Furthermore, such medical devices have a low manufacturing cost as long as the service life is no longer an important criterion.

However, one problem associated with the use of single use medical devices relates to the possibility of using the medical device on another patient. As long as such instruments are not designed to undergo a decontamination or cleaning process, there is still a risk of reusing such medical instruments even if such instruments have already been subjected to a decontamination or cleaning process.

In an attempt to combat multiple uses of single-use medical instruments, patent application WO2010/066187 describes an endoscope in which a detachable medical instrument includes a camera and a non-volatile memory. Such endoscopes have a system for detecting the connection between a detachable medical instrument and a support base enabling the camera operation to be controlled. The nonvolatile memory records the use time of the camera. When the use time stored in the nonvolatile memory is reached, the control unit stops the operation of the camera.

In practice, it has been found that blocking the use of the endoscope at the end of a predetermined duration is very inflexible. In some cases, the inspection process may encounter difficulty and the process cannot be completed within the allotted usage time. In addition, the physician may find it necessary to re-perform the examination procedure on a given patient, and have to use another endoscope.

Patent application EP1935327 describes an imaging system with an endoscope that can be detached from an attachment support. The endoscope is provided with a memory containing endoscope identification data. The imaging system also has an imaging device for processing images taken by the endoscope. The imaging system also has a system for detecting the connection between the endoscope and the connection support. Such systems attempt to make it possible to identify the endoscope and update the parameters for proper operation of the endoscope.

In the same way, document US2004/1064019 describes an imaging system with an endoscope that is detachable from the connection support. The imaging system has a unit that enables the light source of the endoscope to be controlled.

None of these documents provide a solution to the problem of controlling multiple uses of a single-use medical device.

Patent application EP1679030 describes an endoscope which is detachable from a support base. This document describes means for updating parameters of an imaging system.

This document also does not provide a solution to the problem of controlling the safety of use of single-use medical devices.

Document EP1864607 describes a system for managing the cleaning and sterilization of the insertion tube of an endoscope. For this purpose, the management system comprises an acquisition unit adapted to acquire information about the imminent end of an endoscopic examination, so that the cleaning and disinfecting device can be configured accordingly. Such systems are designed to manage cleaning of the endoscope and are not suitable for controlling the use of single use endoscopes.

Disclosure of Invention

The present invention seeks to remedy the drawbacks of the prior art by proposing an imaging system comprising a detachable medical instrument, the use of which is controlled to avoid any contamination between patients, while still providing flexibility of use.

Another object of the invention is to propose an imaging system in which the use of the detachable medical instrument is controlled, while not limiting the length of time it can be used and while allowing it to be reused under the responsibility of the user, and while maintaining traceability of the operation.

To achieve such an object, the imaging system includes:

a medical instrument separable from the connection support, the separable medical instrument including an insertion tube provided with a non-volatile memory and a viewing system forming part of the imaging device;

an imaging device comprising a processor and an image display unit connected to the viewing system; and

a control unit enabling operation of the imaging device to be controlled, and the control unit being connected to a system for detecting a connection between the medical instrument and the connection support.

According to the invention, the non-volatile memory contains identification data of the medical instrument, the identification data being associated with data relating to the use of the imaging device and comprising at least one flag relating to the previous use of the medical instrument, this use data being transmitted by a control unit at each connection and the control unit allowing the operation of the imaging device only when the use data of the imaging device are provided by a user by means of an interface connected to the control unit, the control unit acting at each connection to read the identification data of the medical instrument and the data relating to the use of the imaging device stored in the non-volatile memory.

Furthermore, the system of the invention may also provide at least one and/or more of the following additional features in combination:

the control unit allows the image forming apparatus to operate only when a user provides identification data authorized by the control unit as usage data using the interface;

the control unit requesting the user to use the interface to provide data associated with the patient as usage data;

upon each connection, the control unit acts to record identification data of the user in the non-volatile memory as data relating to use of the imaging apparatus;

upon each connection, the control unit acts to store data associated with the patient in the non-volatile memory as data relating to use of the imaging device;

at each connection, the control unit acts to store the date and time of the start and the date and time of the end of the connection in the nonvolatile memory as data relating to the use of the imaging apparatus;

the control unit storing a flag relating to a previous use of the medical instrument in the non-volatile memory as data relating to a use of the imaging device;

the control unit acting via a display screen or the interface to require authorization from a user for any new use of a medical appliance for which the flag indicates that there has been a previous use of the medical appliance; and

the control unit acts to store usage data of the image forming apparatus in a storage unit at each connection.

Drawings

Various other features are apparent from the following description with reference to the accompanying drawings, which illustrate embodiments of the invention as non-limiting examples.

Fig. 1 is a diagrammatic view showing an imaging system according to the present invention.

Fig. 2 shows an example of an algorithm for illustrating the operating principle of the present invention.

Detailed Description

As can be seen more clearly in FIG. 1, the present invention relates to a medical imaging system 1 including an endoscope 2 adapted to access and examine any part of the human body from a natural or artificial access channel. In a conventional manner, the endoscope 2 makes it possible to examine superficial or deep-inside tissues, hollow organs, lumens or any ducts in the human body for therapeutic, surgical or diagnostic purposes. The present invention relates to endoscopes of various types suitable for use with organs accessible via natural passages, such as, for example, laryngoscopes, bronchoscopes, esophagoscopes, gastroscopes, duodenoscopes, cystoscopes, hysteroscopes and colonoscopes. The invention also relates to any type of endoscope that also makes it possible to access via channels that are made manually in the human body.

In a conventional manner, the endoscope 2 comprises a medical instrument 3 detachable from a connecting block or connecting support 4. The connection block or connection support 4 is typically in the form of a handle or robotic arm. The medical instrument 3 is temporarily mounted relative to the connection support 4. Thus, between the detachable instrument 3 and the connection and support base 4, the endoscope 2 comprises a connection and disconnection system 5 adapted to establish a mechanical and electrical connection quickly while also providing the advantage of making the medical instrument 3 easily detachable from the connection and support base 4. The connection and disconnection system 5 is not described in depth and does not form particularly a part of the present invention, since it is well known to a person skilled in the art.

In general, the medical device 3 is in the form of an insertion tube, has greater or lesser flexibility and is made of a biocompatible material. The insertion tube has a proximal end 6 for connection to the connection support 4 and, at the opposite end of the proximal end 6, has a distal end 7 forming the head of the medical device 3. In a variant embodiment, the endoscope 2 comprises means enabling the distal end 7 of the instrument 3 to be folded or deflected. Of course, it should be understood that the insertion tube of the medical device 3 may be rigid, such that the distal end of the endoscope is not adapted with a deflection system.

The imaging system 1 of the invention further comprises an imaging device 11 comprising a viewing system 12 adapted to the medical instrument 3. The viewing system 12 is an imaging system such as a camera mounted at the distal end 7 of the medical instrument 3 for viewing or examining the interior of a human body. Such a viewing system 12 comprises, for example, an image forming system connected to an image processor unit 14 via a transmission line bundle extending inside the medical instrument 3, which image processor unit 14 is connected to an image display screen 15. The imaging device 11 is not described in further detail, but does not particularly form part of the present invention, as it is well known to a person skilled in the art.

The imaging system 1 also has a control unit 20 that enables the operation of the imaging device 11 to be controlled. This control unit 20 is connected to a system 21 for detecting the connection between the medical instrument 3 and the connection support 4. The control unit 20 also has a human/machine interface 22 enabling a user to input data or operate the control unit 20. This human/machine interface may be, for example, a keyboard, a mouse, a smart card reader, or a touch screen, or the display screen 15 of the imaging device 1.

According to a feature of the invention, the medical instrument 3 is provided with at least one non-volatile memory 23. This non-volatile memory, such as an electrically erasable programmable read-only memory (EEPROM), is connected to the control unit 20 to enable data to be transferred between the control unit and the non-volatile memory 23. Such a non-volatile memory 23 contains data for identifying the medical instrument 3 associated therewith. For example, the non-volatile memory 23 contains the following as data for identifying the associated medical instrument: serial number, manufacturer data, age, … …. Furthermore, as illustrated in the following description, the nonvolatile memory 23 also contains data associated with use of the imaging apparatus 11.

The control unit 20 makes it possible to control the operation of the imaging device 11. For this purpose, the control unit 20 enables the imaging device 11 to operate only when the control unit 20 has identified the user of the endoscope 2. Access to the imaging apparatus 11 is authorized only when the user gives an identification code, if any, to the control unit 20, which is recognized and authorized by the control unit 20. Thus, by using the interface 22, the user provides the control unit 20 with identification data, which in the following description is regarded as usage data. Such usage data is associated with each authorized user and may be biometric data or a confidential access code. Of course, the control unit 20 contains pre-recorded data relating to the user in order to grant or deny any access requested to the imaging apparatus 11.

As can be seen from the above, the control unit 20 records at least the identity of the user as usage data in the non-volatile memory 23. In a preferred variant embodiment, the control unit 20 also records patient-related data in the non-volatile memory 23 as usage data, such as, for example, the identity of the patient or the like. As explained in the following description, for each connection made between the support base 4 and the medical instrument 3, the control unit 20 also records, in the nonvolatile memory 23, the date and time of the start and the date and time of the end of the connection of the medical instrument 3 and the connection support base 4 as data relating to the use of the imaging device 11.

The control unit 20 also records in the non-volatile memory 23 a flag relating to previous use of the medical instrument 3 as data relating to use of the imaging apparatus 11. Thus, each of the nonvolatile memories 23 in the medical instrument 3 contains a flag so that it is possible to know whether the medical instrument 3 has been used with the imaging apparatus 11. When the medical instrument 3 is new, the flag stored in the associated non-volatile memory 23 does not indicate any previous use. When the medical instrument 3 has been used, the control unit 20 modifies the state of the flag recorded in the associated non-volatile memory 23 so that this flag indicates that the medical instrument 3 has been used previously.

As explained in the following description, the medical instrument 3 that has been used can then be used. In this case, the control unit 20 records this information in its non-volatile memory 23 so that the flag indicates a second use of the medical instrument 3.

In a preferred embodiment, the control unit 20 acts (act) on each connection of the medical instrument 3 to record usage data of the imaging device 11 in a memory unit or database 25 connected to the control unit.

The control unit 20 also reads all or some of the identification data of the medical instrument 3 and the usage data of the imaging device 11 stored in the non-volatile memory 23 at each connection between the medical instrument 3 and the connection support 4. Thus, each time the medical instrument 3 is connected to the connection support 4, the user can know the history of the medical instrument 3 and decide whether to use the medical instrument 3.

In another variant embodiment, the control unit 20 also records, in the non-volatile memory 23, an identifier of the imaging device 11 to which the medical instrument 3 is connected, as data relating to the use of the imaging device 11, at the first connection between the support 4 and the medical instrument. Thus, each imaging device 11 is given a different identifier, such as a serial number.

When the medical instrument 3 that has been the subject of previous use is connected, the control unit 20 allows the imaging device 11 to operate only when the identifier of the imaging device recorded in the nonvolatile memory 23 corresponds to the identifier of the imaging device to which the medical instrument 3 is connected. In other words, if the medical instrument 3 has been previously used with one imaging device and is subsequently connected to another imaging device, the control unit 20 of the other imaging device prevents its operation. In this preferred embodiment, the medical instrument 3 can therefore only be used with one imaging device 11.

Thus, the imaging system 1 of the present invention allows the medical instrument 3 to be reused under the full responsibility of the user (doctor). For whatever reason, the physician can decide whether to repeat or restart the examination by confirming the reuse request to be recognized by the control unit 20.

The use of the non-volatile memory 23 as a means of verifying single use makes it possible to fully understand the status of the endoscope and the status of the examination in the normal operating mode:

the medical instrument 3 is not used yet and the examination is not started;

the medical instrument 3 is in use, and the examination has started; and

the medical device 3 is used and the examination is finished.

The imaging system 1 of the present invention also makes it possible to recognize that the operation of the endoscope is being switched to the abnormal mode:

the medical instrument 3 has been used, but the examination is still in progress (accidental disconnection of the medical instrument 3 or accidental switching off of the imaging device). The doctor must confirm reuse of the endoscope; and

the medical device 3 is used and the examination is finished. The physician is repeating the examination and must make the reuse of the endoscope effective.

The use of the control unit 20 makes it possible to have redundant data in relation to the data contained in the medical instrument 3. Information relating to all used medical instruments 3 is stored in the database 25. The information stored in the database 25 also contains confirmation of deviation from normal operation given by the doctor and the doctor's identity.

The operating principle of such an imaging system for enabling single use of consumables has two advantages:

flexibility of use, as such systems do not inhibit use, nor prevent use after a given period of use;

safety is achieved by performing a double check or cross check on the involuntary reuse of the endoscope by means of the non-volatile memory of the medical instrument 3 and by means of the control unit 20.

Thus, the imaging system of the present invention makes it possible to realize a single use of medical instruments safely for a single patient under the responsibility of the user (doctor).

Fig. 2 is a schematic view showing the operation of the image forming apparatus of the present invention.

After step 100 of switching on and initializing the control unit 20, the physician is asked to provide his or her own identity and optionally the patient's identity together, step 101. It should be noted that the physician's identity needs to be entered in order to be able to continue the procedure using the endoscope. As explained above, the user provides the identity data to enable the request for use to be authorized. Of course, any type of process for verifying the identity of a doctor (confidential codes, biometric data, etc.) may be implemented.

Starting with a request to start the examination as in step 102, there is a step 103 for detecting the connection between the medical instrument 3 and the connection support 4. This detection step is performed by the system 21. This step is repeated as long as the medical device 3 is not connected to the connection support 4, step 104. Once the medical instrument 3 is connected to the connection support 4, the control unit 20 acts in step 105 to read the data contained in the non-volatile memory 23. This data corresponds to the identification data of the medical instrument associated with the usage data of the imaging device 11, indicating that the medical instrument 3 has not been previously used, or, conversely, that it has been previously used. This reading is followed by a step 106 of recording the data in the database 25.

In a subsequent step 107, a check of the marking relating to the previous use of the medical instrument 3 is carried out. If the flag indicates a new and unused state, the control unit 20 moves to a subsequent step 108, step 108 being the storage of usage data of the imaging apparatus 11, and in particular in the non-volatile memory 23. If the flag indicates that there is a previous use of the medical instrument 3, the control unit 20 uses the display screen 15 or the interface 22 to alert the user that the medical instrument 3 may be forced to be used, step 109.

If the flag indicates that there is a previous use of the medical instrument 3, the control unit 20 reads the identifier of the imaging device stored in the non-volatile memory 23. If the identifier stored in the non-volatile memory 23 of the medical instrument 3 corresponds to the identifier of the imaging device to which the medical instrument is connected, the control unit 20 authorizes this new use of the medical instrument 3. In contrast, if the identifier stored in the non-volatile memory 23 of the medical instrument 3 does not correspond to the identifier of the imaging apparatus to which it is connected, the control unit 20 prevents the operation of the imaging apparatus 11 and warns the user.

If the user decides not to use the medical device 3 in the test step 110, the method comprises returning to the step 103 of detecting the connection between the medical device 3 and the connection support 4.

If the user decides to force the use of the already used medical instrument 3, the control unit 20 acts in a subsequent storing step 108 to store this new use in the database 25 in order to provide traceability.

The storing step 108 further comprises storing in the non-volatile memory 23 usage data of the imaging apparatus 11, i.e. identity data of the user, data associated with the patient, date and time of connection start, a flag indicating usage of the medical device 3, and an identifier of the imaging apparatus 11.

Thereafter, a diagnostic procedure using the endoscope 2 can be performed. In the examination of step 111, the control unit 20 periodically updates the date and time so that this information is recorded in the nonvolatile memory 23. In the end-of-visit step 112, the date and time of end-of-use is recorded in both the non-volatile memory 23 and the database 25.

If the medical instrument 3 of the endoscope is connected again to the connection support 4 at the end of the examination using the endoscope 2, the control unit 20 acts in step 105 to read the content of the non-volatile memory 23 attached to the medical instrument 3 to determine whether this medical instrument 3 has been the object of previous use. Unlike known prior art solutions, this medical device 3 can be used again by the user under the full responsibility of the user, step 110.

Since various modifications may be made to the invention without departing from the scope thereof, the invention is not to be limited to the examples described and illustrated.

Claims (10)

1. An imaging system, comprising:

a medical instrument (3) detachable from the connection support (4), said detachable medical instrument comprising an insertion tube provided with a non-volatile memory (23) and a viewing system (12) forming part of the imaging device;

an imaging device (11) comprising a processor and an image display unit connected to the viewing system; and

a control unit (20) enabling the operation of the imaging device (11) to be controlled, and the control unit (20) being connected to a system (21) for detecting the connection between the medical instrument (3) and the connection support (4);

the system being characterized in that the non-volatile memory (23) contains identification data of the medical instrument (3), the identification data being associated with data relating to the use of the imaging apparatus and comprising at least one marker relating to a previous use of the medical instrument (3), this usage data is transmitted by the control unit (20) at each connection and the control unit (20) allows the imaging device (11) to operate only if the usage data of the imaging device is provided by a user by means of an interface (22) connected to the control unit (20), -the control unit (20) acts upon each connection to read the identification data of the medical instrument (3) and the data relating to the use of the imaging device (11) stored in the non-volatile memory (23).

2. Imaging system according to claim 1, characterized in that the control unit (20) allows the imaging apparatus (11) to operate only if a user provides identification data authorized by the control unit as usage data using the interface (22).

3. The imaging system according to claim 2, characterized in that the control unit (20) asks the user to use the interface (22) to provide data associated with the patient as usage data.

4. The imaging system according to any one of claims 1 to 3, characterized in that at each connection, the control unit (20) acts to record the identification data of the user in the non-volatile memory (23) as data relating to the use of the imaging apparatus.

5. The imaging system according to claim 1 or 2, characterized in that at each connection the control unit (20) acts to store data associated with the patient in the non-volatile memory (23) as data relating to the use of the imaging device.

6. The imaging system according to claim 4 or 5, characterized in that at each connection, the control unit (20) acts to store the date and time of the start and the date and time of the end of the connection in the non-volatile memory (23) as data relating to the use of the imaging apparatus.

7. The imaging system according to any one of claims 1 to 6, characterized in that the control unit (20) stores a flag relating to a previous use of the medical instrument (3) in the non-volatile memory (23) as data relating to a use of the imaging device.

8. The imaging system according to any one of claims 1 to 7, characterized in that the control unit (20) acts to store an identifier of the imaging device in the non-volatile memory (23) as data relating to use of the imaging device during connection of the medical instrument (3) with the connection support (4), and the control unit (20) authorizes operation of the imaging device (11) only if the identifier of the imaging device recorded in the non-volatile memory (23) corresponds to the identifier of the imaging device to which the medical instrument (3) is connected.

9. The imaging system according to claim 8, characterized in that the control unit (20) acts via a display screen (15) or the interface (22) to require authorization from a user for any new use of a medical instrument (3), wherein for the medical instrument (3) the flag indicates that there has been a previous use of the medical instrument (3).

10. The imaging system according to any one of claims 1 to 9, characterized in that the control unit (20) acts to store the usage data of the imaging device (11) in a storage unit (25) at each connection.