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Title:
COLONIC CLEANSING DEVICE
Document Type and Number:
WIPO Patent Application WO/2011/092689
Kind Code:
A1
Abstract:
The present invention is primarily directed to a body passage cleansing device comprising at least one elastically deformable distal plug perforated by channels, apertures and/or nozzles, wherein said plug is connected to the distal end of an actuating element, and wherein said device further comprises a partial length inner tube surrounding the actuating element in a coaxial manner, and a partial length outer tube which in turn surrounds said inner tube in a coaxial manner. The present invention also encompasses a proximal control handle suitable for use with the aforementioned cleansing device.

Inventors:
NITSAN DAVID (IL)
DUBI SHAY (IL)
BEN-DA AT NADAV (IL)
KRZYZANOWSKI JACK (CA)
Application Number:
PCT/IL2011/000086
Publication Date:
August 04, 2011
Filing Date:
January 25, 2011
Export Citation:
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Assignee:
JETPREP LTD (IL)
NITSAN DAVID (IL)
DUBI SHAY (IL)
BEN-DA AT NADAV (IL)
KRZYZANOWSKI JACK (CA)
International Classes:
A61M3/02; A61M1/00; A61B1/12
Domestic Patent References:
WO2009125387A22009-10-15
WO2008093288A22008-08-07
WO2009125387A22009-10-15
WO2009095915A12009-08-06
Foreign References:
US20070015965A12007-01-18
US20050159648A12005-07-21
US5347992A1994-09-20
US20040210186A12004-10-21
IL2009000346W2009-03-26
IL2009000112W2009-01-29
Other References:
See also references of EP 2528640A1
Attorney, Agent or Firm:
PYERNIK RUTMAN et al. (91 Herzl St, P.O.Box 84106 Beer-Sheva, IL)
Download PDF:
Claims:
CLAIMS :

1. A body passage cleansing device comprising at least one distal plug having a proximal end and a distal end, wherein said at least one plug comprises channels, apertures and/or nozzles which are capable of allowing the passage of a fluid therethrough from said proximal end to said distal end, wherein said plug is connected to the distal end of an actuating element; wherein at least an outer portion of said distal plug is capable of being elastically deformed such that the external outline or diameter thereof may be reduced in response to inwardly-directed compression forces exerted thereon; and wherein said channels, apertures and/or nozzles are in a closed conformation when said distal plug is subject to said compression forces, and in an open conformation when said plug is not subject to said compression forces; and wherein said device further comprises a partial length inner tube surrounding the actuating element in a coaxial manner, wherein said tube extends from the proximal end of said actuating element, and wherein the length of said tube is less than the length of said actuating element, such that a portion of the distal region of said actuating element is left unenclosed by said tube; and wherein said device further comprises a partial length outer tube surrounding said inner tube in a coaxial manner .

2. The device according to claim 1, wherein the actuating element is selected from the group consisting of a wire, a tube, a cord and a rod.

3. The device according to claim 2, wherein the actuating element is a wire.

4. A proximal control handle suitable for use in conjunction with a device according to claim 1, wherein the proximal ends of both the inner and outer tubes of said device are connected to said handle; wherein, the proximal end of the actuating element is movably connected to said handle; wherein said handle comprises means for changing the distance between said handle and the distal end of said actuating element; wherein said handle comprises switching means for directing the output of a fluid-supply channel to one or more fluid outlet channels; and wherein said handle comprises coupling means for coordinating the aforementioned switching between the fluid outlet channels with said means for changing the distance between said handle and the distal end of the actuating element .

5. The proximal handle according to claim 4, wherein the switching means comprises a multi-way fluid valve.

6. The proximal handle according to claim 4, wherein the means for changing the distance between the proximal handle and the distal end of the actuating element comprises a slider mechanism that is movably affixed to the outer surface of said handle, and wherein said actuating element is connected to said slider mechanism.

7. The proximal handle according to claim 6, wherein the coupling means comprises a mechanical actuator which is connected to both the slider mechanism and to the switching means .

8. The proximal handle according to claim 7, wherein the mechanical actuator is an elongate strip, rod or bar.

Description:
COLONIC CLEANSING DEVICE

The present invention provides improvements in the colonic cleansing device described and claimed in international patent application number PCT/IL2009/0003 6 (published as O2009125387 ) . These improvements relate to the following two elements: a) an outer tube disposed such that it surrounds the inner tube, guidewire and distal spray head of the aforementioned colonic cleansing device; b) an improved proximal handle that enables the use of the colonic cleansing device - when connected to appropriate auxiliary equipment such as pumps and controllers - in the following three modes: aspiration, power aspiration and irrigation

In general terms, the presently-disclosed improvements relate to a device which is suitable for use {inter alia) in an endoscope working channel for the purpose of cleansing the lumen and inner wall of a body cavity or passage such as the colonic lumen. The device provides a fluid spray that is capable of effectively loosening solid and semi-solid debris, as well as an aspiration system for removing the sprayed fluid (together with the displaced solid and semi-solid debris). Said device comprises a distal plug/spray head mounted on the distal end of a guidewire. The device of the present invention further comprises a partial length non-collapsible catheter or tube extending from the proximal end of the guidewire and ending a few centimeters short of the distal end of said guidewire. This unique structure enables optimum irrigation and aspiration of the body cavity being treated or cleansed with the ability to prevent and free blockages of the endoscopic working channel which would otherwise occur during the cleansing process. In addition, the device of the present invention (as mentioned above) further comprises a second, outer tube that surrounds the inner tube in a coaxial manner. The presence of this outer tube confers a number of distinct advantages on the cleansing device, all of which will be described hereinbelow. One of the most important of these advantages is the fact that, functionally, the outer tube may be considered to replace the endoscopic working channel in which the device disclosed in co-owned international patent application number PCT/IL2009/000346 (published as WO2009125387 ) was designed to function. In other words, the presence of the outer tube enables the cleansing device described herein to function either within the working channel (or any other instrumental lumen) or within a naturally-occurring channel or passageway (such as the colonic lumen). Thus, while for the sake of convenience, much of the description that follows assumes that the device of the present invention is to be placed within an endoscope working channel, it is to be recognized that said device may equally be used directly in a natural body passageway, such as the colon. The present invention aims to provide means and techniques for supplying cleaning fluid to a spray head or nozzle situated at the distal end of a passageway (e.g. an endoscope working channel or a natural body passage) , at a pressure that is sufficiently high in order to permit generation of a jet spray that will allow efficient cleaning of the colon or other body cavity which lies distally to the distal end of said passageway without causing trauma and tissue injury. The key technical problem that needs to be solved in fulfilling this aim is the generation of a sufficiently high pressure and high flow rate head in order that a jet spray may be formed, without the need for a separate catheter to supply the irrigation fluid to the spray head.

The solution provided by the present invention comprises, in its most general form, a distal spray head unit or plug which is mounted on a thin guidewire (e.g., having a diameter of about 0.3-0.8mm) constructed of a single core wire or multi core strand or (in some embodiments) a very small diameter tube (e.g., having a diameter of about 0.4- 1.5 mm) . This spray head effectively functions as a perforated plug that may be caused to partially or completely block the distal exit of the working channel. Thus, when partially blocking said distal exit, irrigation fluid is supplied through the working channel, said fluid being caused to exit the spray head at a higher pressure, in the form of a jet scatter directed towards the region of the body cavity (e.g. colon) located immediately distal to the distal end of said working channel.

The irrigation fluid may be supplied to the spray head unit in the following manner: the irrigation fluid is fed into the endoscope working channel (or other passageway) using a positive pressure water pump (peristaltic, centrifugal pump, dosing pump, gearwheel pump, etc.) at a pump outlet pressure of between 2 and 10 atmospheres, resulting in a pressure range of 2-8 atm in the outlet nozzle. The flow rate may. range between 0.2 and 2 1/min. Sealing elements, adaptors and connectors using standard Luer components may be used. It is to be emphasized that the abovementioned pressure and flow parameters are for the purpose of illustration only, and do not limit the invention in any way.

The present invention is thus primarily directed to a body passage cleansing device suitable for passage through an endoscopic channel, comprising at least one distal plug having a proximal end and a distal end, wherein said at least one plug comprises channels, apertures and/or nozzles which are capable of allowing the passage of a fluid therethrough from said proximal end to said distal end, wherein said plug is connected to the distal end of an actuating element (such as a wire, tube, cord or rod) ; wherein at least an outer portion of said distal plug is capable of being elastically deformed such that the external outline or diameter thereof may be reduced in response to inwardly-directed compression forces exerted thereon; and wherein said channels, apertures and/or nozzles are in a closed conformation when said distal plug is subject to said compression forces, and in an open conformation when said plug is not subject to said compression forces; and wherein said device further comprises a partial length inner tube surrounding the actuating element in a coaxial manner, wherein said tube extends from the proximal end of said actuating element, and wherein the length of said tube is less than the length of said actuating element, such that a portion of the distal region of said actuating element is left unenclosed by said tube; and wherein said device further comprises a partial length outer tube surrounding said inner tube in a coaxial manner .

In one particularly preferred embodiment of the device of the invention, the actuating element is a wire (also referred to herein as a guidewire) . It should be noted that for the purpose of the present disclosure the term "distal spray head unit" and the like are sometimes used interchangeably with the term "distal plug". It should further be noted that the term 'distal' refers to the direction away from the operator and towards the center of the patient's body. Consequently, the term 'proximal' is taken to refer to the opposite direction.

Examples of suitable distal spray head units that may be used as part of the present invention are disclosed and described in detail in co-owned international application number PCT/IL2009/000346 (published as WO2009125387 ) , as well as in co-owned international application number PCT/IL2009/000112 (published as WO2009/095915 ) which are both incorporated herein by reference.

In one preferred embodiment of the invention, the external diameter of the distal plug when not subjected to inwardly- directed compression forces is slightly larger than the internal diameter of an endoscope working channel. In many cases, the internal diameter of the working, channel in a colonoscope is 3.8 mm and generally in the range of 2 - 4mm.

In one particularly preferred embodiment of the device, the distal plug comprises an O-ring. The additional outer tube defined hereinabove provides the colonic cleansing device with the following additional advantages :

• A stand alone configuration which permits the use of the device in any lumen (natural or instrumental) including endoscopic working channels.

• The device may extend beyond the distal end of the working channel and/or other natural or instrumental lumen .

• A camera may be included on the outer tube and it will enable to view further areas while performing the cleansing .

• Aspiration and irrigation will be done through the gap between the outer tube and the inner tube

• The outer tube may be constructed such that it has a flexible, semi rigid or rigid configuration.

A typical example of the device of the present invention 10 is depicted in Fig. 1. A distal spray head 12 is shown mounted on a flexible guidewire 14, which in turn is disposed coaxially (and movably) within the lumen of partial length inner tube 16. Said inner tube is enclosed by outer tube 18, which itself is partially contained within the lumen of an endoscope working channel 20 or some other instrumental or natural lumen. It is to be noted that in the event that the device is to be used in an endoscope working channel (or similar instrumental lumen) , an attachment seal is inserted around the device at the proximal entrance to said working channel. This sealing element, which may be constructed of flexible material such a biocompatible rubber, plastics or metal, prevents irrigation and debris being sprayed on the operator. In addition, its presence is necessary for maintaining integrity of the negative aspiration pressure that is applied to the space between the inner and outer tubes of the device.

The presence of the above-described outer tube in the device of the present invention results in liquid and debris aspiration taking place through said device (in the space between the inner and outer tubes) rather than through the working channel itself. This arrangement therefore requires the inclusion of a Y-connector at the proximal end of the working channel, in order to direct the aspirated liquid and solid material - via a one-way valve - along a waste line to a collection container.

In another aspect, the present invention further provides a proximal handle that may be used to operate endoscopic instruments, such as the device of the present invention, wherein said handle incorporates a novel mechanism for directing flow to different lumens and conduits. It is to be emphasized that in addition to its use in conjunction with the colonic cleaning device incorporating the partial length outer tube disclosed above, said proximal handle may also be used together with variants of this device (e.g. not comprising an outer tube) and indeed with other endoscopic instruments.

Consequently, in the context of a particularly preferred embodiment of the body passage cleansing device defined hereinabove, said device further comprises a proximal control handle, wherein the proximal ends of both the inner and outer tubes are connected to said handle; wherein the proximal end of the actuating element (for example a guidewire, cord, rod, tube or the like) is movably connected to said handle; wherein said handle comprises means for changing the distance between said handle and the distal end of said actuating element; wherein said handle comprises switching means for directing the output of a fluid-supply channel to one or more fluid outlet channels; and wherein said handle comprises coupling means for coordinating the aforementioned switching between the fluid outlet channels with said means for changing the distance between said handle and the distal end of the actuating element . In one preferred embodiment of this aspect of the invention, the actuating element is a wire.

In one preferred embodiment of this aspect of the invention, the means for changing the distance between the proximal handle and the distal end of the guidewire comprises a slider mechanism that is movably affixed to the outer surface of said handle, wherein the proximal end of said guidewire is connected to said slider mechanism. Further details of a suitable slider mechanism are described in co-owned international patent application number PCT/IL2009/000346 (published as WO2009125387 ) , which is incorporated herein by reference.

In one preferred embodiment of this aspect of the invention, the aforementioned switching means comprises a multi-way fluid valve.

In one preferred embodiment, the coupling means comprises a mechanical actuator (for example in the form of an elongated strip, rod or bar) which is connected to both the aforementioned slider mechanism and to said switching means .

Preferably, the proximal handle disclosed immediately hereinabove comprises one fluid outlet channel in fluid communication with the lumen of the partial length inner tube, and a second fluid outlet channel in fluid communication with the space located between the external surface of said tube and the inner wall of the outer tube.

The above-defined proximal control handle is capable of enabling the cleansing device to be switched between the following three operating modes:

1. Irrigation Mode - the nozzle (spray head unit) is located at the distal edge of the working channel creating the virtual nozzle spray. Irrigation fluid (such as saline) is caused to flow through the working channel (or other instrumental or natural lumen) in the space situated between the inner tube and outer tube of the cleansing device disclosed hereinabove. Control of the flow may be accomplished either semi automatically by pressing a button with predefined flow and pressure levels, or by pressing a pedal switch .

2. Aspiration Mode - the nozzle is located outside of the working channel, preferably 5-20mm on the distal side thereof. Vacuum pressure is activated and liquid and feces remains are aspirated through the space located between the inner and outer tubes, while the device is still inside the body cavity that is being cleansed.

3. Power Aspiration Mode - the distal head is positioned such that it completely seals the distal exit of the endoscope working channel. In addition to the vacuum pressure, a distally-directed positive flow pressure is activated through the lumen of the inner, partial- length tube, in order to assist in the aspiration process and prevent or clear blockage of the working channel by debris.

It may thus be appreciated from the foregoing summary of the three different operating modes that the proximal handle possesses elements that are capable of serving two key functions: a) movement of the distal spray head between the various locations described above; and b) diversion of the irrigation fluid into the desired route (i.e. into the lumen of the inner partial-length tube during working channel clearing and into the space between the inner and outer tubes during regular irrigation) .

While specifically intended for use in conjunction with the irrigation/aspiration device of the present invention, it is to be noted that the proximal control handle may also be used for other purposes during endoscopic procedures, for example the injection of ink or other marker material into the colonic lumen.

Various preferred embodiments of the proximal handle of the present invention will now be de scribed, with reference to the following drawings: Fig. 2, which provides a general view of a first embodiment of the proximal handle of the present invention.

Fig. 3, which provides a close-up view of valve actuator mechanism of a first embodiment of the proximal handle .

Figs. 4 - 6, which depict a first embodiment of a water box (manifold) of the present invention, and the way in which said water box may be used to enable a colonic cleansing device connected thereto to be switched between different operating modes.

Fig. 7, which shows the way in which the external slider is used to switch between different operating modes of a connected colonic cleansing device.

Fig. 8, which shows a second embodiment of the proximal handle of the present invention in which the external slider has been pushed forward distally, thereby enabling the connected cleansing device to operate in irrigation mode.

Fig. 9, which shows the second embodiment of the proximal handle of the present invention in which the external slider has been pulled proximally, thereby enabling the connected cleansing device to operate in power aspiration mode.

Fig. 10, which provides a close-up view of the water box (manifold) of the second embodiment of the proximal handle, in a configuration which permits fluid flow into both the lumen of the inner tube of a connected colonic cleansing device and into the space between the inner and outer tubes. Fig. 11, which provides a close-up view of the water box (manifold) of the second embodiment of the proximal handle, in a configuration which permits fluid flow only into the lumen of the inner tube of a connected colonic cleansing device.

Fig. 12, which illustrates the various elements employed to control the position of the manifold valve lever by means of altering the position of the external slider .

Proximal handle - 1 embodiment:

One preferred embodiment of the proximal control handle of the present invention is schematically illustrated in Fig. 2. In this embodiment, the handle comprises a main body which consists of the handle shell, as well as a slider that is used to control the axial (distal-proximal) movement of the guide wire, thereby controlling the position of the distal spray head unit. It may be seen from Fig. 2 that in addition to the externally-visible parts of the handle mechanism 22, the proximal handle also comprises, in its distal portion, a water box 24, which contains the elements required for directing the irrigation fluid flow from the pump to the distal end of the device along the relevant pathways. In particular, the mechanism housed in the water box enables routing of the irrigation fluid between irrigation and water channel clearing (power irrigation) modes As shown in the figure, the outlet of the water box is connected (by means of the guidewire) to the distal spray head 26.

Fig. 3 provides a more detailed view of the working components of the proximal handle, including the external slider 32 which is connected to an internally-located slider 34, the purpose of which is to move an actuator, which in turn causes rotation of water valve 30. In the example shown in this figure, the valve is similar to state of the art stopcock valve. The channel in which the slider moves may be notched, in order that the operator is able to receive tactile feedback concerning the position of the slider (and hence the current operating mode of the device) .

Fig.- 4 provides a detailed view of the water box 24 and of its relation to the other key components of the cleansing device of the present invention. Thus, water valve 30 is shown located close to irrigation fluid inlet 42, which receives irrigation fluid pumped from a fluid reservoir or other externally-located fluid source. This fluid input will then be directed (in accordance with the position of the water valve lever) to one or both of two fluid channel routes: the space between the inner tube 16 and the outer tube 18 and/or the lumen of said inner tube 16. Finally, this figure also illustrates the location of guidewire 14 within the lumen of inner tube 16. A guidewire sealing element 44 (e.g. an 0-ring) is incorporated into the device to prevent fluid loss around the guidewire 14, while permitting the smooth axial movement of said guidewire through water box 24.

The tubing and water routing may be configured in two main modes :

1) irrigation through the inner tube lumen always open;

2) irrigation through the inner tube lumen either open or closed.

The first of these two modes ("always open mode") is illustrated in Figs. 5A and 5B. Thus, in Fig. 5A, the water valve lever is positioned such that the irrigation fluid is caused to flow simultaneously through two channels: the lumen of the inner tube (channel A) and the space located between the inner and outer tubes (channel B) . This irrigation mode is achieved by means of the operator pushing the slider forward (i.e. distally) and then retracting slightly, in order that the distal spray head comes to rest on the distal outlet of the endoscopic working channel. Simultaneously, the actuator connected to the slider will move the water valve into the desired position, whereby both channels A and B are brought into fluid communication with the irrigation fluid source. In this state, the irrigation fluid that is pumped distally through channels A and B will pass through the apertures in the distal spray head in the form of a fluid spray which may be used to cleanse the region of the body cavity (e.g. colon) that lies immediately beyond the distal end of the working channel.

The device may then be switched from the irrigation mode to the power aspiration mode (shown in Fig. 5B) by means of the operator causing further retraction (i.e. proximal movement) of the slider, such that the distal spray head is more tightly compressed against the distal working channel exit, thereby closing the distal head apertures, and thus preventing any further fluid . transfer across said distal head. The corresponding movement of the actuator causes the valve to be rotated to a position in which channel B is closed, while channel A remains in the open position. In this mode, the pumped fluid passes through the lumen of the inner tube (i.e. channel A). Negative pressure is then applied to an aspiration inlet in the proximal handle that is (in this mode) in fluid contact with channel B. In this way, irrigation fluid that exits the distal end of the inner tube lumen is aspirated, proximally, through the space between the inner and outer tubes (channel B) .

The second of the main modes mentioned hereinabove - i.e. the mode in which the inner tube lumen may be in either closed or open states (in relation to the irrigation fluid inlet) in accordance with the position of the water valve lever - is depicted in Fig. 6. The left-side panel of the figure illustrates the situation wherein channel A is open, thereby allowing irrigation fluid to pass distally through the lumen of the inner tube. In the right-side panel, however, channel A is closed and channel B is open, in which state the irrigation fluid inlet is in fluid contact only with the space between the inner and outer tubes.

Fig. 7 illustrates the way in which manipulation of the slider by the operator is used in order to change the operating mode of the cleansing device of the present invention. Thus, in panel A, the device is in aspiration mode, in which the slider is in its forward-most position, and negative aspiration pressure is applied to the space between the inner and outer tubes. Movement of the slider into a more proximal location brings the device into irrigation mode, in which irrigation fluid is pumped distally through the space between the inner and outer tubes (and in the ^always open' mode, also through the lumen of the inner tube). Finally, further proximal movement of the slider brings the device into its power aspiration mode, in which irrigation fluid is pumped distally through the inner tube lumen against, a completely sealed distal head unit, and then aspirated proximally through the space between the inner and outer tubes.

Proximal handle - 2nd embodiment:

A second preferred embodiment of the proximal handle of the present invention will now be described in detail, with reference to Figs. 8-11. This embodiment of the handle has a similar external form to the first embodiment described hereinabove, and may be used to control the operation of a connected device in a similar manner. There are, however, some important differences between the two embodiments with respect to, firstly, the valve actuator, and, secondly, the internal arrangement of the water box (also referred to herein as a manifold) .

Fig. 8 provides a side view of the second preferred embodiment of the proximal handle of the present invention, having a manifold 48 situated at its distal end and an external slider 52 shown in its most distal position. Also shown is the externally-placed valve actuator rod 46 (which replaces the internal slide actuator of the first embodiment described above and represented by part number 34 in Fig. 3) . This actuator rod is shown in more detail in Fig. 12, in which it may be seen that said rod is fitted with a distal stop element 66 and a proximal stop element 68 , said stop elements being designed to be respectively pushed and pulled by the external slider 52 . It may also be seen that the distal end of valve actuator rod 46 is fitted with a pair of jaws 70 (orientated at right angles to the actuator rod itself) which are used to grasp the movable end of valve lever 50 . Thus, when external slider 52 is pushed distally, the movable end of valve lever 50 is similarly moved in a distal direction (as shown in Fig. 8) . Conversely, when slider 52 is pulled by the operator in a proximal direction, the movable end of valve lever 50 is rotated in an anti-clockwise direction, and thereby moved into its proximal position, as shown in Fig. 9. It should also be noted that since the guidewire 53 of the colonic cleansing device is connected to the slider 52, movement of said slider distally or proximally will respectively cause distal advancement or proximal retreat of the distal plug that is connected to said guidewire. In this way, movement of external slider 52 is able to control two functions: the distal-proximal position of the distal plug of the connected cleansing device and the channeling of irrigation fluid through manifold 48.

As in the case of the first embodiment of the proximal handle disclosed and described hereinabove, the second embodiment of the handle may be configured to operate in one or other of the following two main modes, with respect to a colonic cleansing device connected to said handle:

1) irrigation through the inner tube lumen always open;

2) irrigation through the inner tube lumen either open or closed.

The first of · these two modes ("always open mode") is illustrated in Figs. 10 and 11. Thus, in Fig. 10, the water valve lever 50 is positioned such that the irrigation fluid (introduced via inlet 54) is caused to flow simultaneously through two channels: the lumen of the inner tube (channel A; indicated by numeral 56) and the space located between the inner and outer tubes (channel B; indicated by numeral 64) . This irrigation mode is achieved by means of the operator pushing the external slider forward (i.e. distally) and then retracting slightly, in order that the distal spray head comes to rest on the distal outlet of the endoscopic working channel. Simultaneously, the actuator connected to the slider will move the water valve into the desired position, whereby both channels A and B are brought into fluid communication with the irrigation fluid inlet (via a channel formed in the pivot of the water valve lever) . In this state, the irrigation fluid that is pumped distally through channels A and B will pass through the apertures in the distal spray head in the form of a fluid spray which may be used to cleanse the region of the body cavity (e.g. colon) that lies immediately beyond the distal end of the working channel .

The device may then be switched from the irrigation mode to the power aspiration mode - shown in Fig. 11 - by means of the operator causing further retraction (i.e. proximal movement) of the external slider, such that the distal spray head is more tightly compressed against the distal working channel exit, thereby closing the distal head apertures, and thus preventing any further fluid transfer across said distal head. The corresponding movement of the actuator causes the valve to be rotated in an anticlockwise direction to a position in which channel B (indicated as 64 in Fig. 10) is closed, while channel A (56) remains in the open position. In this mode, the pumped fluid that enters the manifold through fluid inlet 54 passes through the lumen of the inner tube (i.e. channel A) only. Negative pressure is then applied to an aspiration inlet in the proximal handle that is (in this mode) in fluid contact with channel B. In this way, irrigation fluid that exits the distal end of the inner tube lumen is aspirated, proximally, through the space between the inner and outer tubes (channel B) . It is to be noted that that manifold used in this preferred embodiment of the proximal handle incorporates several O-rings 62 that are used to provide fluid sealing of the various components that are connected thereto, such as inner tube 58, outer tube 60 and the guidewire (not shown) .

While the mode described immediately hereinabove (i.e. "inner tube always open" mode) is, for many applications, the preferred mode, it is also possible to configure the manifold such that the inner tube lumen may be in either closed or open states (with relation to the irrigation fluid inlet) in accordance with the position of the water valve lever.

It is to be noted that while the manifold (water box) of the second preferred embodiment is functionally very similar to the comparable element of the first embodiment, there are a number of differences with respect to the arrangement of the various channels within said manifold. It was found by the inventors that the channel arrangement used in the second embodiment is especially advantageous in relation to the tooling required during manufacture of the device. Thus, while several tools are required to manufacture the manifold of the first embodiment, the second embodiment requires the use of only one such tool. It should also be noted that, as stated hereinabove, the proximal handle (in its various different embodiments) that is disclosed and described herein may be used in conjunction with several different elongate instruments that are designed for insertion into a body passage (such as the colon) . Thus, in the above description of the fluid channeling within the manifold (water box) of the proximal handle, the "outer tube" is to be understood to also include within its scope other tubular structures including (but not limited to) the internal wall of a body passage (such as the colon or other part of the gastrointestinal tract) , and other non-natural tubular elements such as the internal wall of an endoscopic channel (e.g. the working channel of a colonoscope) .

As explained hereinabove, the device of the present invention may be inserted into a body passage via the working channel of an endoscope, such as a colonoscope. In one preferred embodiment of such a case, the length of the guidewire and of the inner and outer tubes is arranged such that the proximal handle described hereinabove is situated approximately 70 cm proximal to the proximal end of the endoscope. This arrangement enables the device to be held and manipulated by an assistant (e.g. nurse, technician or assisting physician) standing or sitting at the aforementioned distance from the endoscope (and hence the patient), thereby permitting the primary operator to perform his/her procedures in an unhindered manner. The proximal handle shell may be manufactured from ABS, polycarbonate, Delrin and other plastic resins depending on the compatibility with the sterilization method to be used (autoclaving, Gamma radiation or ETO, preferably, by means of casting in mass production. The length of housing may generally be about 80-120mm, and the diameter of fluid passages provided therein may generally be in the range of 2mm-4mm. Both the partial length inner tube and the outer tube may be made from ETFE, PTFE or other plastic resins which are compatible with the applicable sterilization method with low friction coefficient and sufficient rigidity to support the device without collapsing. In an alternative flexible configuration, the inner tube may be made of silicon or rubber resin, preferably from PTFE for low friction between the guidewire and tube as well as between the tube and the working channel, having a length of about 150cm-210cm, depending on the endoscope length used as well as the external extension tubing length, and having an inner diameter generally in the range of 1mm preferably smaller to reduce hysteresis effects (around A G16) , and a wall thickness of about 0.25mm to 0.4mm. The guidewire is preferably made from stainless steel 304V with an optional configuration of PTFE coating to reduce potential friction between the wire and the inner PTFE tube and its diameter may generally be in range of 0.5-0.7 mm, preferably about 0.6 mm.

The partial-length inner tube is generally constructed of PTFE tubing (for low friction) or ETFE, depending on the sterilization method of the device to be used, and has an external diameter of about 1-mm - 1.6 mm and a wall thickness of about 0.25 mm. The outer tube may also be constructed from the aforementioned materials, and may' have an external diameter that is commonly in the range of 2mm - 4mm. However, both the inner and outer tubes may have diameters that differ considerably from these exemplary values, particularly when the device into which they are incorporated is intended for use in natural lumens or in instrumental lumens other than colonosocopic working channels. In any event, it is to be recognized that all of the aforementioned measurements are given only as a general guide and do not limit the scope of the present invention in any way.

The device of the present invention may form part of a system that additionally includes a control console, an irrigation fluid pump (e.g. diaphragm pump, peristaltic pump or a gear wheel pump) a vacuum pump (e.g. THOMAS diaphragm pump, piston pump) a transformer (e.g., medical grade transformer Mean well/ 200W Medical series) , safety timer, irrigation pump relay and vacuum pump relay, all of which devices are well known to the skilled artisan in the field.

The aforementioned additional equipment that may be used in conjunction of the presently-disclosed device may be conveniently contained within a discrete housing. This housing is connected by suitable tubing to a water tank used for supplying the irrigation fluid to the cleansing device of the invention. In a preferred embodiment of the device of the invention may withstand irrigation pressures of up to 10 atmospheres and flow rates of about 1 liter/min. The streamed washing fluid may be controlled by the operator by means of pedal switch electrically connected to the console. The console is also connected to the working channel of a colonoscope for applying vacuum therethrough by means of a vacuum pump and aspirating debris, fecal material and other particulate matter into a waste tank.