Patent Description:
The term "reconditioning", here and in the present description, generally refers to a complete cycle of treatment of a medical instrument, for example prewashing, washing, disinfecting, drying and storing the medical instrument.

As is known, tubular flexible medical instruments exist, made of various materials, in particular metal, plastic and/or rubber used in the medical field to explore, to examine using optical apparatuses or to empty the body's natural cavities, introduced through natural or artificial paths. Such endoscopic instruments may be, for example, colonoscopes, bronchoscopes, gastroscopes or other.

These flexible endoscopes allow to carry out check-ups and/or interventions on the patient in a non-invasive manner, acting from the inside of the body, thus avoiding having to intervene surgically from the outside.

Generally, an endoscope is formed by a control and service unit and an operating unit, connected by a flexible tube in which all the tubular elements or connecting channels between the two operating units are housed. In the most complex endoscopic instruments, there may be as many as eight connection channels, with functions for example for the conduction and suction of sterile or contaminated substances, housing of optical and surgical devices or other.

As can easily be imagined, normal endoscopic instruments are frequently used throughout the day inside structures such as hospitals, clinics, or suchlike. Therefore, before any new use, these instruments require a reconditioning process, in order to guarantee they are aseptic at the time of reuse.

Three main steps of reconditioning of an endoscopic instrument can be distinguished, which come between the last use and subsequent use: a first prewash step, a second washing and disinfection step and a third drying and storage step. Usually these three main steps are carried out in as many dedicated machines, so that for each step it is necessary to position the endoscopic instrument correctly in each specific machine.

For the instrument to be made suitably aseptic, each of the steps cited above must cover both the outside part and also the internal connection channels. To do this, in each of the three steps, the channels are connected, by means of corresponding connectors, to a corresponding processing machine, then to a machine that does the prewash, then to a machine that does the washing and disinfection, and finally to a machine which does the drying and storage. Normally, therefore, passing from one step to another and from one machine to another, the instrument must be handled so that the individual connectors of the individual connection channels are first connected and then disconnected.

As can be understood, the need for a prolonged and repetitive handling of the endoscopic instrument, essential to the reconditioning steps performed as described above, forces frequent and prolonged interventions by an operator. Because of these interventions, the medical instrument is also at high risk of re-contamination. The risk of re-contamination is difficult to overcome and reduce with known reconditioning machines and methods, as these are obligated process passages or steps.

For example, in document <CIT>, an endoscope is described which is provided with a device for cleaning the site where the endoscopy is performed.

This document is therefore mainly intended to solve the problem of cleaning the site, or "lumen", where the endoscopy is performed, while the problem of contamination of the instrument is not posed, especially in steps of non-use, for example during the reconditioning steps of the endoscope.

Document <CIT> concerns an apparatus for cleaning and disinfecting an endoscope.

This document takes into consideration a situation in which the endoscope is connected to a single apparatus to be cleaned and disinfected, but the problem of subjecting the endoscope to a reconditioning cycle comprising several reconditioning steps, typically three steps as described above, is not taken into consideration.

None of the above documents, <CIT> or <CIT>, therefore poses the problem of contamination of a medical instrument, for example an endoscope, which is subjected to a plurality of reconditioning steps in which it may be subjected to contamination, in particular following its repeated handling, for example to transfer the medical instrument from one step to another.

<CIT> discloses a system for reconditioning a medical instrument which comprises a device having a single connector configured to be removably connected to the medical instrument and suitable for being connected to counter-connectors of distinct dedicated reconditioning machines, said connector and said counter-connector being mating and a method to recondition a medical instrument which comprises a first step of univocally connecting a medical instrument to a connector, an intermediate step of reconditioning said medical instrument, in which said connector, with said medical instrument connected, is associated with a corresponding reconditioning counter-connector, said intermediate reconditioning steps of said medical instrument are carried out in succession, said method providing to keep said connector always connected to said medical instrument during the course of said one intermediate reconditioning step and also during the passage from one intermediate step to another, and, on each occasion, in relation to the intermediate reconditioning steps that follow each other, to connect/ disconnect said single specific connector to/from a respective counter-connector of the specific reconditioning machine in which a respective specific intermediate reconditioning step is carried out and a final step of univocally disconnecting said connector from said medical instrument once the reconditioning cycle has been completed, before said medical instrument is again used.

Other limitations and disadvantages of conventional solutions and technologies will be clear to a person of skill after reading the remaining part of the present description with reference to the drawings and the description of the embodiments that follow, although it is clear that the description of the state of the art connected to the present description must not be considered an admission that what is described here is already known from the state of the prior art.

There is therefore a need to provide a method and system for reconditioning a medical instrument, in particular an endoscope, which can overcome at least one of the disadvantages of the state of the art.

One purpose of the present invention is therefore to perfect a method for reconditioning a medical instrument, in particular an endoscope, in which the risk of contamination or re-contamination during the various reconditioning steps is drastically reduced compared to known reconditioning methods.

Another purpose of the present invention is to perfect a method for reconditioning a medical instrument, in particular an endoscope, in which the operations to transport and temporarily retrieve the medical instrument by the operators, during its reconditioning, which operations are generally carried out manually, are drastically simplified and unified, ensuring fast connection between the instrument and individual machines for each step of the reconditioning cycle.

Another purpose of the present invention is to perfect a method for reconditioning a medical instrument, in particular an endoscope, which dramatically reduces the possibility of positioning and recognition errors in the connection between the instrument and the machine for each of the steps of the reconditioning cycle.

Another purpose is to obtain an effective and functional system to implement said method, which also has an advantageously ergonomic shape and which preferably allows a single identification step of the connection between the instrument and the machine for each of the steps of the reconditioning cycle.

In accordance with the above purposes and according to a first aspect of the invention, a system of reconditioning a medical instrument is as defined in annexed claim <NUM>.

A reconditioning method of a medical instrument is according to annexed claim <NUM>.

The method and system according to the present description therefore allow to isolate the medical instrument from any possible risk of contamination due to the repeated connections and disconnections of the connectors; indeed the single connector connected on the instrument side collects the connections at the terminals of the instrument. The same single specialized connector is used in the various reconditioning steps, since the same connection is identical in the counter-connectors of the reconditioning machines. The present invention therefore allows to carry out a single connection on the instrument side before the beginning of the reconditioning cycle, that is, upstream of the first intermediate reconditioning step, and a single disconnection at the end of the cycle, where for example the cycle can be concluded in a drying and storage/preservation apparatus or cabinet, from which the instrument is removed for a new use.

These and other aspects, characteristics and advantages of the present disclosure will be better understood with reference to the following description, drawings and attached claims. The drawings, which are integrated and form part of the present description, show some forms of embodiment of the present invention, and together with the description, are intended to describe the principles of the disclosure.

The various aspects and characteristics described in the present description can be applied individually where possible. These individual aspects, for example aspects and characteristics described in the attached dependent claims, can be the object of divisional applications.

It is understood that any aspect or characteristic that is discovered, during the patenting process, to be already known, shall not be claimed and shall be the object of a disclaimer.

We shall now refer in detail to the various embodiments of the present invention, of which one or more examples are shown in the attached drawings. Each example is supplied by way of illustration of the invention and shall not be understood as a limitation thereof. For example, the characteristics shown or described insomuch as they are part of one embodiment can be adopted on, or in association with, other embodiments to produce another embodiment. It is understood that the present invention shall include all such modifications and variants.

<FIG> is used to describe a device <NUM> for the treatment of a medical instrument <NUM>, in particular, for example, but not limited to, a flexible endoscope, shown schematically in <FIG>, usable in the embodiments described here in relation to a reconditioning cycle of the medical instrument <NUM>.

Here and in the present description, a reconditioning cycle can be understood, for example, as a cycle that comprises, or consists of, a prewash step, a washing and disinfection step and a step of drying and storage/preservation/stocking of the medical instrument <NUM>. Consequently, the beginning of the reconditioning cycle is represented by the beginning of the first prewash step, while the end of the reconditioning cycle may be understood, in the embodiments described here, to correspond to the moment when the medical instrument <NUM> is removed from its storage condition for a new use.

In some embodiments, the device <NUM> comprises a multiple connector <NUM>, removable in itself and in relation to the medical instrument <NUM>, and a multiple and fixed counter-connector 12a-c. The connector <NUM> and counter-connector 12a-c are coordinated so that they are correctly coupled to each other quickly and easily for an operator.

The connector <NUM> is a standardized multiple connector that has unified seatings to connect individual tubular elements, or flexible pipes <NUM>, to coordinated apertures or terminals present in the medical instrument <NUM>, for example an endoscope.

According to a variant, an intermediate connection element is provided, suitable to facilitate the correct connection of the connector <NUM> and counter-connector 12a-c.

The fixed counter-connector 12a-c can be installed on any reconditioning machine whatsoever that performs at least one of the steps of the treatment cycle of the medical instrument <NUM> discussed. With reference to <FIG> and <FIG>, a counter-connector 12a of a first prewash machine <NUM>, a counter-connector 12b of a second washing and disinfection machine <NUM> and a counter-connector 12c of a third drying and optionally storage machine <NUM> are shown schematically by way of example.

The counter-connectors 12a, 12b and 12c are unified and all coherent and mating with the connector <NUM> for a quick, reliable and secure connection.

The connector <NUM> comprises a connection head <NUM> provided with a series of connection elements <NUM>.

A specific tubular treatment element <NUM> is connected to each of the connection elements <NUM>, for example inside a casing <NUM> of the connector <NUM>, in which tubular treatment element <NUM> a particular fluid for washing, disinfection or otherwise can flow.

Each of the tubular elements <NUM> is flexible and can be connected by means of suitable connection means to apertures or inlets of the medical instrument <NUM>, so as to reach the channels and the internal zones.

As we said, the counter-connector 12a-c is installed on board each of the machines <NUM>, <NUM> and <NUM>, and in this regard comprises a support plate <NUM> which can be connected, for example, to one of the walls of the machine <NUM>, <NUM>, <NUM>, in which the functions operable in the device <NUM> converge.

The connection head <NUM> of the connector <NUM> is inserted into a seating <NUM> of the counter-connector 12a-c, so as to obtain a stable and sealed connection.

The removable and sealed connection between the connection head <NUM> and the seating <NUM> can be carried out in any way whatsoever, for example by means of a rotating, bayonet or similar attachment system.

In this regard, in the connection head <NUM> of the connector <NUM>, pins <NUM> can be provided by way of example, able to be inserted into corresponding slits <NUM>, made in the seating <NUM> of the counter-connector 12a-c.

One of the slits <NUM> is visible in <FIG>. The other slit will be made on the seating <NUM> in a position diametrically opposite to the slit <NUM> visible in the drawing.

The seating <NUM> is configured to rotate with respect to the plate <NUM> so as to make the connection of the connector <NUM> to the counter-connector 12a-c stable.

The rotation of the seating <NUM> can be effected by means of a corresponding drive lever <NUM>, which can be driven manually by an operator so that the pins <NUM> are positioned on the bottom of the corresponding slits <NUM>.

The connection head <NUM> able to engage in said seating <NUM> thus represents, as we said, one of the various removable connection means of the connector <NUM> to the counter-connector 12a-c.

On the machine side, the counter-connector 12a-c has counter-connection elements <NUM> to allow the passage of a determinate treatment fluid according to the treatment step of the medical instrument <NUM>.

This passage can be univocal, or also provide a return.

Each of the counter-connection elements <NUM> is able to engage fluidically, hence to be removably connected to a corresponding connection element <NUM> of the connector <NUM>.

As we said, the medical instrument <NUM> can be an endoscope provided with a flexible tube <NUM> that connects a control and service unit <NUM> and an operating unit <NUM>.

Inside the flexible tube <NUM>, all the channels or connection elements between the two units <NUM> and <NUM> are collected. The channels can be used, for example, for functions of conduction and/or aspiration of sterile or contaminated substances, to accommodate connections for optical or surgical devices or other.

Each of the connection elements or channels of the medical instrument <NUM> is connected to the tubular elements <NUM> of the connector <NUM> by means of suitable removable connection means. This step is shown schematically in <FIG>.

The connector <NUM> with the medical instrument <NUM> connected can be put in a suitable container, for example a rack, where the medical instrument <NUM> is housed in a predefined position at least with its connector. Advantageously, according to some possible embodiments, from now on and until the end of the treatment cycle, only the rack will be moved, transported and handled, while the medical instrument <NUM> is no longer handled, remaining connected and protected by the connector <NUM>.

According to other variants, the medical instrument <NUM>, being always connected to the connector <NUM> in the passage between one reconditioning step and the other, can also be handled by an operator in terms of movement and/or transport between one machine and the other and/or in terms of positioning or housing in a desired reconditioning machine. However, thanks to the present invention, the operator will no longer be required to connect and disconnect the medical instrument <NUM> from the connector <NUM>, since these two elements will always remain connected during the reconditioning cycle and in the passage from one intermediate step to the other, thus isolating the medical instrument <NUM>, and advantageously the apertures, or terminals thereof, from the risk of contamination. In practice therefore, the connector <NUM>, being always connected to the medical instrument <NUM> from the beginning to the end of the conditioning cycle, during the intermediate reconditioning steps and in the passage between them, protects the medical instrument <NUM> from contamination, and in particular protects the apertures or terminals thereof, since the latter are always connected to the tubular elements <NUM> of the connector <NUM> and hence isolated from the outside.

At the end of this step of univocal connection of the tubular elements <NUM> to the connection elements, channels or terminals of the medical instrument <NUM>, for example using the rack or being positioned manually, the connector <NUM>, which is connected on the instrument side, is then associated, on the machine side, with the counter-connector 12a of the machine <NUM>, so that the medical instrument <NUM> can be subjected, for example, to a first pre-washing step, in which the tubular elements <NUM> are also advantageously prewashed inside.

The connection between the connector <NUM> already connected on the instrument side and the counter-connector 12a on the machine side is carried out by inserting the connection head <NUM> inside the seating <NUM> of the counter-connector 12a in a sealed manner, so that the connection elements <NUM> are connected to the corresponding counter-connection elements <NUM>.

At the end of the prewash step, where the device or machine concerned is only dedicated to the prewash, the connector <NUM>, always held connected with the medical instrument <NUM>, is rapidly and effectively removed from the counter-connector 12a of the prewash machine <NUM>.

At this point, the rack containing the connector <NUM> connected to the medical instrument <NUM> that has been subjected to the prewash step, or directly the medical instrument <NUM> connected to the connector <NUM> if the rack is not provided, is inserted into a washing and disinfection machine <NUM>, advantageously without needing to re-connect the various channels of the medical instrument <NUM> one by one to the machine <NUM>, since, thanks to the fact that the connector <NUM> is already connected with its tubular elements <NUM> to the apertures or terminals of the medical instrument <NUM>, it is sufficient to connect the machine side connector <NUM> with a single standardized operation. In fact, the machine-side connection operation is carried out simply and quickly by inserting the connector <NUM> into the counter-connector 12b of the machine <NUM>, in a similar way to that described for the machine <NUM>, therefore by means of a sealed insertion of the connection head <NUM> in the seating <NUM> of the counter-connector 12b, so that the connection elements <NUM> are again connected to the corresponding counter-connection elements <NUM>. As we said, in some possible variants, the medical instrument <NUM> is in no way handled, but left in the rack, while in other variants it can be moved by an operator directly without using a rack, in both cases with the provision that the same medical instrument <NUM> will still be always connected to the connector <NUM>, which therefore protects it and isolates it from the risk of contamination.

At the end of this washing and disinfection step inside the machine <NUM>, in which advantageously the tubular elements <NUM> and the apertures or terminals of the medical instrument <NUM> are then also washed and disinfected inside, by means of suitable fluids and/or treatment systems, the connector <NUM> is disengaged from the counter-connector 12b and hence another treatment step of the medical instrument <NUM> can be performed in another machine <NUM> as described below in detail, that is to say, a drying and storage step, the latter generally carried out in a machine <NUM> which is a drying and storage apparatus, also called drying and storage cabinet, where the medical instrument <NUM> can be dried and stored under sterile conditions until required for a new use.

The drying and storage step is carried out by moving the rack, containing inside it the connector <NUM> with the medical instrument <NUM> connected, into the machine <NUM>, where the rack is deposited, or by directly transporting the medical instrument <NUM>, without using the rack, and housing it inside the machine <NUM>, for example, deposited horizontally, hanging vertically, in an elongated/extended configuration, or wound or rolled or otherwise, as needed. The connector <NUM>, always connected on the instrument side, is connected on the machine side to the counter-connector 12c of the drying and storage machine <NUM>, by means of a new sealed insertion of the connection head <NUM> into the seating <NUM> of the counter-connector 12c of the machine <NUM>, so that the connection elements <NUM> are again connected to the corresponding counter-connection elements <NUM>.

At the end of this step carried out in the machine <NUM>, in which the tubular elements <NUM> and the apertures or terminals of the medical instrument <NUM> are advantageously also dried inside, the connector <NUM> and the medical instrument <NUM> can be stored in a connected condition in the machine <NUM> itself, until required for a new use, or can be disconnected and separated in the event of a new use, as shown schematically in <FIG>, that is to say, the tubular elements <NUM> of the connector <NUM> can be univocally separated from the channels or connections of the medical instrument <NUM> on which a complete reconditioning cycle has been carried out, to be used in a new use.

In particular, since the machine <NUM> can typically be used for both drying and storing/preserving reconditioned medical instruments <NUM>, until required for a new use, the disconnection can be performed at the time when a medical instrument <NUM> is removed from the machine <NUM> for a new use, thus guaranteeing sterility until before said new use.

The medical instrument <NUM> has therefore been subjected to a complete reconditioning cycle, advantageously by a single connection operation, at the beginning of the reconditioning cycle, and disconnection, at the end of the reconditioning cycle when the instrument <NUM> has to be used again, of the corresponding channels or internal connections with the tubular elements <NUM> of the connector <NUM>.

The connection of the tubular elements <NUM> of the connector <NUM> is therefore only made prior to the entrance into the first treatment machine <NUM>, whereas the disconnection is made only at the end of the reconditioning cycle, as required, when it is necessary to remove the medical instrument <NUM> from the machine <NUM> for a new use of the medical instrument <NUM> itself, dried and stored/preserved in sterile conditions, contained in a rack in a container, in a drawer or case, or free, but still inside the machine <NUM>.

The univocal operations to connect and disconnect the medical instrument <NUM> to the connector <NUM> naturally reduce the risk of contamination of the medical instrument <NUM> and also reduce working times, making the treatment cycle faster and more efficient.

The medical instrument <NUM> is therefore handled only at the beginning of the treatment cycle to perform a univocal operation to connect the various channels with the connector and at the end of the cycle to disconnect.

According to possible embodiments of the method described here, in the intermediate steps of the cycle, for the movements from one machine <NUM>, <NUM> and <NUM> to another, only the rack or other housing container of the medical instrument <NUM> and the connector <NUM>, in some variants, are handled, but the medical instrument <NUM> itself is not handled, at least in terms of connection or disconnection with respect to the connector <NUM>. Alternatively, in other variants of the method, the medical instrument <NUM> can also be handled directly, in order to transport it or position it in relation to the various machines <NUM>, <NUM> and <NUM>, but not in terms of connection and disconnection with respect to the connector <NUM>, which is always connected during the reconditioning cycle and in the passage from one step to another, thus isolating as much as possible the medical instrument <NUM> and the apertures, or terminals, thereof, from the risk of contamination. It is also possible that, for some movements or positioning in relation to one or more of the machines <NUM>, <NUM> and <NUM>, a suitable rack, drawer, case, or similar container is used, and for other movements the medical instrument <NUM>, always connected to the connector <NUM>, is handled directly to be moved or positioned in relation to one or more of the machines <NUM>, <NUM> and <NUM>.

The connection shown between the connection head <NUM> and the seating <NUM> of any of the counter-connectors 12a, 12b or 12c is extremely precise, therefore the possibility of coupling errors of the connector to the counter-connector is drastically reduced.

The connection of the connector <NUM> to any one of the counter/connectors 12a, 12b or 12c is also very fast and allows a univocal identification that simplifies the monitoring of the reconditioning cycle.

The operations performed on the connector <NUM> during the reconditioning cycle or the complete treatment of the medical instrument <NUM> are also advantageously facilitated by the ergonomic shape of the connector <NUM> itself.

It is clear that modifications and/or additions of parts may be made to the method and system for reconditioning a medical instrument, in particular an endoscope, as described heretofore, without departing from the field and scope of the present invention.

It is also clear that, although the present invention has been described with reference to some specific examples, a person of skill in the art shall certainly be able to achieve many other equivalent forms of method and system for performing a reconditioning cycle on a medical instrument, in particular an endoscope, having the characteristics as set forth in the claims and hence all coming within the field of protection defined thereby.

Claim 1:
A system of reconditioning a medical instrument (<NUM>) comprising a device (<NUM>) and distinct dedicated reconditioning machines (<NUM>, <NUM>, <NUM>) to recondition said medical instrument (<NUM>), said device (<NUM>) comprising a single connector (<NUM>) configured to be removably connected to the medical instrument (<NUM>) and to counter-connectors (12a, 12b, 12c) of said distinct dedicated reconditioning machines (<NUM>, <NUM>, <NUM>), said connector (<NUM>) and said counter-connector (12a, 12b, 12c) being mating,
wherein said connector (<NUM>) comprises a connection head (<NUM>) provided with a series of connection elements (<NUM>) and on one side a plurality of tubular elements (<NUM>),
wherein a specific tubular treatment element (<NUM>) is connected to each of the connection elements (<NUM>), inside a casing (<NUM>) of the connector (<NUM>), in which tubular treatment element (<NUM>) fluid for washing or disinfection can flow,
wherein each of the tubular elements (<NUM>) is flexible and is connectable by means of suitable connection means to apertures or inlets of the medical instrument (<NUM>), so as to reach the channels and the internal zones,
wherein the counter-connector (12a, 12b, 12c) is installed on each of the machines (<NUM>, <NUM>, <NUM>) and comprises a support plate (<NUM>) which is connectable to one of the walls of the machine (<NUM>, <NUM>, <NUM>) and a seating (<NUM>) and
wherein the connection head (<NUM>) of the connector (<NUM>) is inserted into the seating (<NUM>) of the counter-connector (12a, 12b, 12c), so as to obtain a stable and sealed connection.