Patent Description:
Endoscopes are imaging devices used to image the inside of the body. They generally have a control handle coupled to a long elongated flexible tubular body with an imaging lens and light at a distal end. Optical fibres are often employed to relay light from an illumination source in the handle to the distal tip of the elongated body. Most endoscopes incorporate air/water channels to deliver air and water to the distal tip for the purpose of cleaning the lens (water) or insufflating tissue close to the tip. The air is generally provided by a pump that is connected to an air line in the handle of the endoscope. Water is provided by an external water bottle configured for connection to the handle of the endoscope by a water line and pump. Irrigation and rinsing tube sets and systems are described in <CIT>, <CIT> and <CIT>.

In some endoscopes, air can be routed by means of a valve to an external water bottle to pressurise the bottle. In this type of endoscope, the handle has adjacent air and water ports provided on the handle to fluidically connect a water bottle with the endoscope by means of air and water tubes. In use, air is pumped from the endoscope to the water bottle via an air tube to pressurise the bottle, and the pressure forces water in the bottle into the endoscope through the water line, where the water is used to clean the lens of the endoscope. <FIG> and <FIG> illustrate this type of system, with a handle of an endoscope <NUM> with protruding water port <NUM> and air port <NUM>, water bottle <NUM>, air and water tubes <NUM>, <NUM>, bottle cap <NUM> glued to a distal end of the air and water tubes, and a connector <NUM> glued to a distal end of the air and water tubes and having a distal end <NUM> dimensioned to mate the fluidically connect with the water port <NUM> and air port <NUM>. <FIG> shows the connector <NUM>, tubes <NUM>, <NUM> and bottle cap <NUM> prior to assembly.

The water bottle, tubes and connector are generally used for a <NUM>-hour period before being disposed of. This will mean that they are used on several different patients during this period. While none of these components come into contact with the patient, there is a risk of back-flow (reflux) of water from the endoscope into the water bottle during use. This can cause contamination of water in the water bottle, which can lead to cross-contamination when the endoscope is used on a different patient using the same water bottle and tubing. This problem can be addressed by changing the whole water supply assembly after every patient, although this is an expensive solution as well as being environmentally unfriendly.

To address this problem, it is recommended to incorporate a non-return valve into the fluidic conduits to prevent reflux of water into the bottle. Incorporating a non-return valve into existing machines is expensive and time consuming. An alternative solution is to incorporate a non-return valve into the water line as illustrated in <FIG> in which the non-return valve <NUM> is provided in the water tube <NUM>. However, while this will prevent reflux water into the bottle allowing the bottle to be re-used, the rest of the water supply assembly (cap, tubing, and connector) all must be disposed of because they are glued together and cannot be separated from the potentially contaminated connector. Again, this is an expensive solution.

It is an object of the invention to overcome at least one of the above-referenced problems.

The Applicant has addressed the problems of the prior art by providing a modified connector, that is provided in a two-part form with a distal part detachably attached to a proximal part and where the water lumen of the distal part incorporates a one-way valve. This is illustrated in an exploded view in <FIG> showing the detachable distal and proximal parts and the non-return valve in the distal part. With this connector, after the endoscope has been used with a patient, the connector is detached from the air and water ports of the endoscope, and the distal part of the connector is detached from the proximal part, and a replacement distal part is attached to the proximal part to re-assemble the connector, which is then reattached to the ports of the endoscope. In this way, only the distal part of the connector must be discarded and the remaining parts (proximal part of the connector, attached water and air tubes, bottle cap and bottle) may be re-used for the remainder of the recommended <NUM>-hour period. This allows a kit to be supplied comprising a water bottle, a tubing assembly with bottle cap, air and water tubes, and a connector, and several replacement distal parts for the connector, that can be used with several patients during a <NUM>-hour period without any risk of cross-contamination.

In a first aspect, the invention provides a connector to fluidically connect a medical instrument with an air tube and a water tube, the connector comprising a housing having:.

characterised in that the connector is a two-part connector comprising a proximal part comprising the proximal openings and a distal part comprising the distal openings, wherein the proximal part and distal part are configured for detachable engagement, and wherein the second through lumen comprises a non-return valve disposed in the distal part of the housing.

In any embodiment, the distal openings are configured to fluidically connect with air and water ports of a scoping device. Typically, the ports are protruding ports.

In any embodiment, the distal openings are configured to fluidically connect with an air-water (AW) port of an endoscope.

In any embodiment, each proximal opening comprises a recessed socket dimensioned to receive an end of an air or water tube.

In any embodiment, the recessed socket of the first through lumen has a diameter greater than the recessed socket of the second through lumen.

In any embodiment, the proximal part and distal part are configured for detachable friction-fit engagement.

In any embodiment, a proximal end of the distal part of the housing comprises projecting ports, and a distal end of the proximal part of the housing comprises recessed ports configured to receive the projecting ports to fluidically couple the distal and proximal parts of the housing.

In any embodiment, the proximal part comprises a housing section dimensioned to receive the distal part. An example of this embodiment is illustrated in <FIG>.

In any embodiment, the housing section of the proximal part comprises a base section and a lid section hingedly mounted to the base section and adjustable from an open configuration to allow insertion of the distal part into the housing section and a closed configuration in which the distal part is enclosed within the housing section. The base section may be dimensioned to allow all, substantially all, or part of the distal part of the housing nest within the base when the lid is open.

In any embodiment, the lid section comprises a clamp configured to clamp the proximal part of the housing to the air port or water port of the medical instrument when the lid section is in the closed configuration. The clamp may be a C-shaped element configured to snap fit to the air or water port.

In any embodiment, the lid section comprises a clamp configured to clamp the proximal part of the housing to the air port of the medical instrument when the lid section is in the closed configuration.

In any embodiment, the distal opening of the second through lumen is recessed proximally relative to the distal opening of the first through lumen.

In any embodiment, the connector consists essentially of a proximal part comprising the housing section and the lid section, a distal part, and a non-return valve. In this embodiment, the distal part and non-return valve are disposed and detached and discarded after every use, and the proximal part may be re-used and only replaced after a defined period of use, for example <NUM> hours.

The invention also provides an air and water tube assembly comprising:.

In any embodiment, the distal ends of the air and water tubes are non-detachably attached to the connector (e.g. glued).

In any embodiment, the assembly comprises a bottle cap non-detachably connected to a proximal part of the water tube and air tube to fluidically connect a bottle with the air and water tubes when the cap is attached to the bottle. The cap generally includes bores for receipt of the distal part of the water tune and air tube. Generally, the water tube is fixed to the cap such that a distal part of the tube extends beyond the cap (allowing the tube project into the bottle and into the water in the bottle when the cap is fitted to the bottle).

In any embodiment, the water tube has a bore that is smaller than a bore of the second tube.

The invention also provides a kit of parts comprising an assembly of the invention, and additionally including one or more replacement distal parts of the connector configured for detachable attachment to the proximal part of the connector.

In any embodiment, the medical device is an endoscope of the type having adjacent air and water ports on the handle of the endoscope. In any embodiment, the endoscope is an Olympus <NUM> endoscope. Other endoscopes suitable for use with the connector, assembly and methods of the invention include the Fuji <NUM>, Fuji <NUM> and Pentax <NUM>/<NUM> endoscopes.

An additional and related aspect of the invention is an adapter for a connector of an air and water tube assembly, that allows connectors of conventional air and water tube assemblies (e.g. as shown in <FIG> and <FIG>) connect with an air and water port of a medical instrument such as a scoping device (e.g. an endoscope or the like) while allowing re-use of the air and water assembly with multiple patients. The adapter comprises a housing having:.

Typically, the air and water port sockets of the distal end of the adapter are configured to fluidically connect with air and water ports of an endoscope, typically an Olympus <NUM>, Fuji <NUM>, Fuji <NUM> or Pentax <NUM>/<NUM> endoscopes.

Other aspects and preferred embodiments of the invention are defined and described in the other claims set out below.

As used herein, the term "comprise," or variations thereof such as "comprises" or "comprising," are to be read to indicate the inclusion of any recited integer (e.g. a feature, element, characteristic, property, method/process step or limitation) or group of integers (e.g. features, element, characteristics, properties, method/process steps or limitations) but not the exclusion of any other integer or group of integers. Thus, as used herein the term "comprising" is inclusive or openended and does not exclude additional, unrecited integers or method/process steps.

The invention will now be described with reference to specific Examples. These are merely exemplary and for illustrative purposes only: they are not intended to be limiting in any way to the scope of the monopoly claimed or to the invention described. These examples constitute the best mode currently contemplated for practicing the invention.

Referring to the drawings and initially to <FIG> and <FIG>, there is illustrated a connector to fluidically connect a medical instrument with an air tube and a water tube according to the invention, indicated generally by the reference numeral <NUM>. The connector <NUM> comprises a housing <NUM> having a first through lumen <NUM> for air having a proximal opening <NUM> and a distal opening <NUM>, and a second through lumen <NUM> for water having a proximal opening <NUM> and a distal opening <NUM>. The housing <NUM> has a proximal part <NUM> comprising the proximal openings <NUM>, <NUM> configured for detachable engagement with a distal part <NUM> comprising the distal openings <NUM>, <NUM>. The second through lumen <NUM> has a non-return valve <NUM> disposed in the distal part of the housing that in use prevents back-flow of water from the endoscope to the water bottle and tubing.

In more detail and referring to <FIG>, a proximal end of the distal part <NUM> of the housing has projecting outlet ports <NUM> configured for friction fit engagement with corresponding sockets <NUM> disposed on a distal end of the proximal part <NUM> of the housing, to fluidically couple the distal part <NUM> and proximal part <NUM> together.

Referring to <FIG> and <FIG>, there is illustrated an air and water assembly according to the invention <NUM> and comprising a two-part connector <NUM>, air tube <NUM>, water tube <NUM>, and bottle cap <NUM>. The bottle cap <NUM> is shown attached to a water bottle <NUM>. The air tube <NUM> has a distal end <NUM> fluidically connected to the first through lumen <NUM> of the connector <NUM> and a proximal end <NUM> connected to a through hole <NUM> in the bottle cap <NUM> for fluidic connection with the bottle <NUM>. The water tube <NUM> has a distal end <NUM> fluidically connected to the second through lumen <NUM> of the connector <NUM> and a proximal end <NUM> connected to a through hole <NUM> in the bottle cap <NUM> for fluidic connection with the water bottle <NUM> for pressurising the bottle. Although not shown, the proximal end <NUM> of the water tube <NUM> extends into the bottle to that an inlet of the water tube is under the level of the water in the bottle during use. It will be appreciated that the air and water tubes illustrated are quite short but in practice they will be much longer.

<FIG> also shown the handle <NUM> of an endoscope with air port <NUM> and water port <NUM>. <FIG> shows the air and water ports <NUM>, <NUM> in more detail.

In use, and referring to <FIG>, the air and water assembly <NUM> is used to couple the air and water ports <NUM>, <NUM> of the endoscope handle <NUM> with a water bottle <NUM>. The bottle <NUM> is filled with water and the bottle cap <NUM> is then attached to the bottle to seal the bottle. During use of the endoscope, pressurised air is provided to the endoscope from an external pump, and upon actuation the pressurised air may be diverted to the water bottle through the connector <NUM> and air tube <NUM> to pressurise the bottle. Upon pressurisation, water in the bottle is forced into the endoscope through the water tube <NUM> and connector <NUM> where the water is routed by internal tubing a distal end of the endoscope for the purpose of cleaning the lens. The flow of water can be stopped by diverting the flow of pressurised air to the bottle through the air tube <NUM>. During the procedure, any backflow (reflux) of water into the tubing and bottle is prevented by the non-return valve in the distal part of the connector, ensuring that the proximal part of the connector, tubing and water bottle remain sterile. After the endoscopy procedure in a patient is finished, the connector <NUM> is detached from the handle of the endoscope and the endoscope may then be cleaned and sterilised. To prepare the air and water assembly for the next patient, and to ensure that the tubing and bottle and water is not contaminated with biological matter from the first patient, the distal part <NUM> of the connector <NUM> (containing the non-return valve in the second through lumen) is detached from the proximal part <NUM> and discarded, and a replacement distal part is attached to the proximal part. The connector is then attached to the air and water ports of the sterilised endoscope, and an endoscopy procedure may be carried out on the next patient without any risk of cross-contamination. In this way, the use of the two-part connector with a non-return valve in the water lumen of the distal part allows the bottle, water, tubing, and proximal part of the connector to be re-used numerous times during a <NUM>-hour period, with only the distal part of the connecter being discarded after every patient.

<FIG> illustrates an adapter fitting according to the invention, indicated generally by the reference numeral <NUM>, in which parts described with reference to the previous embodiments are assigned the same reference numerals. The adapter fitting <NUM> is designed to be used with an existing air and water assembly such as that illustrated in <FIG> and <FIG> and is used to convert a conventional one-part connector into a modified two-part connector with a non-return valve. The adapter <NUM> comprises a housing <NUM> having a distal end <NUM> with an air port socket <NUM> dimensioned to mate with the air port <NUM> of an endoscope <NUM> and a water port socket <NUM> dimensioned to mate with the water port <NUM> of the endoscope. A proximal end <NUM> comprises an air port <NUM> and a water port <NUM> identical to the air and water ports of the endoscope (in this case an Olympus <NUM> endoscope) and configured to fluidically couple with air and water sockets of the conventional connector <NUM>. The adapter comprises an air lumen <NUM> fluidically connecting the air port socket <NUM> and the air port <NUM> and a water lumen <NUM> fluidically connecting the water port socket <NUM> and water port <NUM>. A non-return valve <NUM> is disposed in the water lumen <NUM> to prevent backflow of water through the adapter.

In use, the adapter <NUM> may be coupled to a connector of a conventional air and water tube assembly, and then attached to the air and water port of an endoscope. Upon completion of the endoscopy in a first patient, the adapter is detached from the connector and discarded, and a replacement adapter attached to the connector before use in an endoscopy procedure in a second patient. The adapter functions in the same way as the distal part of the two-part connector, ensuring that if any backflow of water occurs that it does not come into contact with the connector allowing the connector and downstream tubing and bottle to be re-used.

<FIG> illustrate a connector according to an alternative embodiment of the invention, indicated generally by the reference numeral <NUM>, in which parts described with reference to the previous embodiments are assigned the same reference numerals. In this embodiment, the proximal part <NUM> of the connector has a housing section <NUM> that is dimensioned to the distal part <NUM> of the connector is a nested arrangement. The housing section has a base section <NUM> and a lid section <NUM> hingedly mounted to the base section and adjustable from an open configuration to allow insertion of the distal part <NUM> into the housing section and a closed configuration in which the distal part <NUM> is enclosed within the housing section. The base section and lid section are dimensioned to receive and enclose the distal part of the connector when the lid section is closed, with a distal end of the housing section open to allow the distal part of the connector fluidically couple to the air and water ports of the endoscope. The distal part <NUM> is shaped such that the distal opening <NUM> of the second through lumen <NUM> is recessed proximally relative to the distal opening <NUM> of the first through lumen <NUM>. This allows the distal opening <NUM> fluidically couple with a proximal end <NUM> the air tube <NUM> but also exposes a distal end <NUM> of the air tube when the connector is coupled to the air tube. As illustrated in <FIG>, an underside of the lid section <NUM> incorporates a clamp <NUM> that is configured to snap-fit around the distal end <NUM> of the air tube <NUM> when the lid is closed. As illustrated in <FIG>, the annular flange <NUM> on the air tube <NUM> combined with the clamp <NUM> serves to lock the connector to the endoscope.

Claim 1:
A connector (<NUM>, <NUM>) to fluidically connect a medical instrument (<NUM>) with an air tube and (<NUM>) a water tube (<NUM>), the connector comprising a housing (<NUM>) having:
a first through lumen (<NUM>) with a proximal opening (<NUM>) configured to couple with the air tube (<NUM>) and a distal opening (<NUM>) configured to couple with an air port (<NUM>) of the medical instrument; and
a second through lumen (<NUM>) with a proximal opening (<NUM>) configured to couple with a water tube (<NUM>) and a distal opening (<NUM>) configured to couple with a water port (<NUM>) of the medical instrument;
characterised in that the connector is a two-part connector comprising a proximal part (<NUM>) comprising the proximal openings (<NUM>, <NUM>) and a distal part (<NUM>) comprising the distal openings (<NUM>, <NUM>), wherein the proximal part and distal part are configured for detachable engagement, and wherein the second through lumen (<NUM>) comprises a non-return valve (<NUM>) disposed in the distal part of the housing.