• 专利附录
  • 专利说明
  • 权利要求
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    • 专利摘要:
    COLON CLEANING DEVICEThe present invention relates mainly to a body passage cleaning device comprising at least one distally deformable plug elastically perforated by channels, openings and / or nozzles, said plug being connected to the distal end of an actuator element and said device also comprising an inner tube of partial length which surrounds the actuating element in a coaxial manner, and an outer tube of partial length which, in turn, surrounds said inner tube in a coaxial manner. The present invention also includes a cableproximal control suitable for use with the aforementioned cleaning device.
    公开号:BR112012018577A2
    申请号:R112012018577-2
    申请日:2011-01-25
    公开日:2020-09-15
    发明作者:David Nitsan；Shay Dubi；Nadav Ben-'at；Jack Krzyzanowski
    申请人:Jetprep Ltd.；
    IPC主号:
    专利说明:

    EE 1/19 “COLON CLEANING DEVICE” Field of the Invention: The present invention features improvements in the colon cleaning device described and claimed in the international patent application | 5 number —PCT / IL2009 / 000346 (published as WVVO2009125387). These improvements refer to the following two elements: a) an external tube arranged to surround the inner tube, the guide wire and the distal spray head of the aforementioned colon cleansing device; b) an improved proximal cable that allows the use of the colon cleansing device - when connected to the appropriate auxiliary equipment, such as, for example, pumps and controllers - in the following three modes: aspiration, vigorous aspiration and irrigation.
    Summary of the Invention: In general terms, the improvements now presented refer to a device that is suitable for use, among other things, in an endoscope working channel, for the purpose of cleaning the lumen and the internal wall of a cavity or passage of the body, such as the lumen of the colon. The device offers a fluid spray that can effectively detach solid and semi-solid waste, as well as a suction system for removing the sprayed fluid (along with displaced solid and semi-solid waste). Said device comprises a distal head / obturator mounted on the distal end of a guidewire. The device of the present invention also comprises a catheter or a partial length non-collapsible tube that extends from the proximal end of the guide wire and ends a few centimeters before the distal end of said guide wire. This unique structure allows for better irrigation and aspiration of the body cavity to be treated or cleaned, with the ability to prevent and release blockages in the endoscopic working channel that would otherwise occur during the cleaning process. In addition, the device of the present invention (as mentioned above) also comprises a second outer tube that surrounds the inner tube in a coaxial manner.
    The presence of this external tube gives a series of distinct advantages over the cleaning device, which will be described below.
    One of these most important advantages is that, functionally, the outer tube can be considered to replace the endoscopic working channel, in which the device presented in the international patent application in co-ownership number PCT / IL2009 / 000346 (published as WO2009125387 ) was designed to work.
    In other words, the presence of the external tube allows the cleaning device described here to work either within the working channel (or any other instrumental lumen) or within a naturally occurring channel or passageway (such as, for example, the colon lumen ). Consequently, for the sake of convenience, although most of the description below assumes that the device of the present invention must be placed within a working channel of the endoscope, it should be considered that said device can also be used directly in a passage body, such as the colon.
    The present invention aims to offer means | and techniques for supplying cleaning fluid to a nozzle or head | sprayer located at the distal end of a passage (for example, a | working channel of the endoscope or a natural passage of the body), to a | pressure that is high enough to allow the generation of jet spray, which will allow efficient cleaning of the colon or other body cavity that is distally to the distal end of said | without causing trauma and tissue damage.
    The key technical problem that needs to be solved to achieve this objective is the generation of a sufficiently high pressure and a head with a high flow rate, to | that a jet spray can be formed without the need for a | separate catheter to supply the irrigation fluid to the spray head.
    The solution presented by the present invention comprises, in its most general form, a spray head or distal plug, which is mounted on a thin guidewire (for example, with a diameter of approximately 0.3-0.8 mm) consisting of a single-core wire or multi-core cable or (in some embodiments) a very small diameter tube (for example, with a diameter of approximately 0.4-1.5 mm). This spray head works effectively as a perforated plug that can partially or completely block the distal outlet of the working channel. Consequently, when partially blocking said distal outlet, the irrigation fluid is supplied through the working channel, said fluid leaving the spray head at a higher pressure, in the form | of a jet dispersion directed to the region of the body cavity (for example, colon) located immediately distal to the distal end of said working channel.
    The irrigation fluid can be supplied to the spray head as follows: the irrigation fluid is fed into the working channel of the endoscope (or other passage), using a positive pressure water pump (centrifugal peristaltic pump) , metering pump, gear pump, etc.) at a pump outlet pressure between 2 and 10 atmospheres, resulting in a pressure range of 2-8 atmospheres at the outlet nozzle. The flow rate can vary between 0.2 and 2 1 / min. Sealing elements, adapters and connectors with standard Luer components can be used. It should be emphasized that the pressure and flow parameters mentioned above are provided by way of illustration only and not by way of limitation to the present invention.
    The present invention is therefore directed mainly to a body passage cleaning device suitable for passage through an endoscope channel, which comprises at least one distal obturator having a proximal end and a distal end; - said plug comprising channels, openings and / or nozzles that allow the passage of a fluid through them from said proximal end to said distal end; - the said plug is connected to the distal end of an actuator element (such as, for example, a wire, tube, cable or rod);
    | 4/19 - at least one external portion of said | distal obturator can be elastically deformed, such that the outer contour or its diameter can be reduced in response to the internally directed compression forces exerted on it; - said channels, openings and / or nozzles being in a closed conformation when said distal obturator is subjected to the forces of compression and in an open conformation when said distal obturator is not subjected to said compression forces; - said device also comprising an internal tube of partial length around the actuator element in a coaxial manner, said tube extending from the proximal end of said actuator element and said length of said tube is less than the length said actuator element, such that a portion of the distal region of said actuator element is not bounded by said tube, and; - said device also comprising an outer tube of partial length around said inner tube in a coaxial manner.
    In a particularly preferred embodiment of the device of the present invention, the actuator element is a wire (also referred to herein as a guide wire).
    It should be noted that, for the purposes of this description, the term "distal spray head" or the like is sometimes used interchangeably with the term "distal obturator". In addition, it should be noted that the term "distal" refers towards the direction away from the operator and towards the center of the patient's body. Therefore, the term “proximal” is used to refer to the opposite direction. Examples of suitable distal spray heads that can be used as integral parts of the present invention are presented and described in detail in international patent application jointly owned by PCT / IL2009 / 000346 (published as WO Z2009125387), as well as in the patent application international in
    5/19 | co-property number PCT / 1L2009 / 000112 (published as WO2009 / 095915), which are both incorporated herein by reference.
    In a preferred embodiment of the present invention, the outer diameter of the distal obturator, when not subjected to internally directed compression forces, is slightly larger than the inner diameter of an endoscope working channel. In many cases, the internal diameter of the working channel in a colonoscope is 38 mm and generally varies between 2 mm and 4 mm.
    In a particularly preferred embodiment of the device of the present invention, the distal obturator comprises an "O" ring.
    The additional external tube defined above offers the colon cleaning device the following additional advantages: * an independent configuration that allows the use of the device in any lumen (natural or instrumental), including working channels of the endoscope.
    “The device can extend beyond the distal end of the working channel and / or another natural or instrumental lumen.
    * the camera can be included in the outer tube and will allow you to see more areas while cleaning.
    * aspiration and irrigation will be done through the space between the outer tube and the inner tube.
    | * the outer tube can be constructed in such a way that it has a flexible semi-rigid or rigid configuration.
    A typical example of the device of the present invention (10) is shown in Figure 1. A distal spray head (12) is shown mounted on a flexible guide wire (14) which, in turn, is coaxially disposed (and mobile) ) within the lumen of the partial length inner tube (16). Said inner tube is bounded by the outer tube (18) which, in itself, is partially contained within the lumen of an endoscope working channel (20) or some other instrumental or natural lumen.
    It should be noted that in the event that the device needs to be used in | a working channel of the endoscope (or in a similar instrumental lumen), a fixation seal is introduced around the device at the entrance proximal to said working channel.
    This sealing element, which can be made of flexible material, such as, for example, biocompatible rubber, plastic or metal, prevents irrigation and spraying of residues on the operator.
    In addition, its presence is necessary to i maintain the integrity of the negative suction pressure, which is applied to the | space between the inner and outer tubes of the device.
    The presence of the outer tube described above in the device of the present invention results in the aspiration of liquid and waste through said device (in the space between the inner and outer tubes) and not | through the work channel itself.
    This provision 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 - through a unidirectional valve - along a waste line to a collection container.
    In another aspect, the present invention also features a proximal cable that can be used to operate endoscopic instruments, such as, for example, the device of the present invention, said cable incorporating a new mechanism to direct the flow to different lumens and channels .
    It should be noted that in addition to its use in conjunction with the colon cleansing device that comprises the external tube of partial length described above, 6 proximal cable can also be used together with variants of this device (for example, that does not comprise a tube external) and, in fact, with other endoscopic instruments.
    Therefore, in the context of a particularly preferred embodiment of the body passage cleaning device defined hereinbefore, said device also comprises a proximal control cable, - the proximal ends of both the inner and outer tubes being connected to said cable; - being that the proximal end of the actuator element (for example, guide wire, cord, rod, tube or the like) is connected in a mobile way to said cable; - said cable comprising means for changing the distance between said cable and the distal end of said actuator element; - said cable comprising switching means for directing the outlet of a fluid supply channel to one or more fluid outlet channels, and; - wherein said cable comprises coupling means for coordinating the aforementioned switching between fluid outlet channels with said means for changing the distance between said cable and said distal end of the actuator element.
    In a preferred embodiment of this aspect of | present invention, the actuator element is a wire. | In a preferred embodiment of this aspect of | In the present invention, the means for changing the distance between the proximal cable and the distal end of the guide wire comprises a sliding mechanism which is movably attached to the external surface of said cable, the | proximal end of said guidewire is connected to said mechanism | slider.
    More details of an appropriate sliding mechanism are described in international co-owned patent application number PCT / IL2009 / 000346 (published as WO (20) 09125387), which is hereby incorporated by reference.
    In a preferred embodiment of this aspect of the present invention, the aforementioned switching means comprise a multidirectional fluid valve.
    | 8/19 | In a 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 the sliding mechanism | mentioned above and to said means of switching. | Preferably the proximal cable shown immediately above comprises a 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 outer surface of said tube and the inner wall of the outer tube. ! The proximal control cable defined above can | allow the cleaning device to be switched between the following three operating modes:
    1. Irrigation mode - the nozzle (spray head) | 15 is located on the distal edge of the working channel, creating the spray nozzle | virtual. The irrigation fluid (such as saline) is required to | flow through the working channel (or other instrumental or natural lumen) in the space between the inner tube and the outer tube of the cleaning device | described earlier. Flow control can be achieved or semi | 20 automatically, by pressing a button with pre-defined pressure and flow levels, or by pressing a foot switch.
    2. Aspiration mode - the nozzle is located outside the working channel, preferably 8-20 mm on the distal side of it. The vacuum pressure is activated and leftover liquids and feces are sucked through the space between the inner and outer tubes, while the device is still inside the body cavity being cleaned.
    3. Vigorous suction mode - the distal head is positioned in such a way that it completely seals the distal outlet of the endoscope's working channel. In addition to the vacuum pressure, a positive flow pressure directed distally is activated through the lumen of the inner tube of
    Lo A DP PR EDP TP EDP AND AA EA AND PR TP EI TP TP PPP PP PP PP AND PTP IR DT ED a | | . 9/19 partial length, to assist in the suction process and prevent or eliminate the blockage of the working channel by waste. | It can, therefore, be appreciated from the previous synthesis of the three different operational modes, that the proximal cable has elements that are capable of serving two main functions: a) movement of the distal spray head between the various locations described above, and; b) deviation of the irrigation fluid to the desired route (that is, to the lumen of the internal tube of partial length during the cleaning of the working channel and to the space between the internal and external tubes during regular irrigation).
    Although it was specifically designed to be used in conjunction with the irrigation / aspiration device of the present invention, it should be noted that the proximal control cable can also be used for other purposes during endoscopic procedures, such as, for example, injection ink or other marker material in the colon lumen.
    Brief Description of the Figures: Various preferred embodiments of the proximal cable of the present invention will now be described with reference to the accompanying drawings.
    Figure 2 presents an overview of a first embodiment of the proximal cable of the present invention.
    Figure 3 shows an approximate view of the valve actuating mechanism of a first modality of the proximal cable.
    Figures 4-6 illustrate a first embodiment of a water box (dispenser) of the present invention and the way that said water box can be used so that a colon cleaning device connected to it can be switched between the different modes operational.
    Figure 7 shows the way in which the external slider is used to switch between the different operating modes of a connected colon cleansing device.
    Figure 8 illustrates a second cable mode next! of the present invention, in which the external slider has been pushed distally, thus allowing the connected cleaning device to operate in irrigation mode.
    Figure 9 illustrates a second embodiment of the proximal cable of the present invention, in which the external slider has been pulled proximally, thus allowing the connected cleaning device to operate in vigorous suction mode.
    Figure 10 shows an approximate view of the water box (distributor) of the second modality of the proximal cable, in a configuration that allows the flow of the fluid to both the lumen of the inner tube | of a connected colon cleansing device as well as space | between the inner and outer tubes.
    | Figure 11 shows an approximate view of the water box (distributor) of the second modality of the proximal cable, in a configuration that allows fluid flow only to the lumen of the inner tube of an connected colon cleaning device.
    Figure 12 illustrates the various elements used to control the position of the manifold valve lever, by changing the position of the external slider.
    DETAILED DESCRIPTION OF THE INVENTION: Proximal cable - first embodiment: A preferred embodiment of the proximal control cable of the present invention is illustrated schematically in Figure 2.
    "| In this modality, the cable comprises a main body consisting of the cable in the shape of a shell, as well as a slider that is used to control the axial (distal-proximal) movement of the guide wire, thus controlling the position of the distal spray head.
    It can be seen in Figure 2 that, in addition to the externally visible parts of the cable mechanism (22), the proximal cable also comprises, in its distal portion, a water box (24), which contains the elements necessary to direct the flow of irrigation fluid from the pump to the distal end of the device along the relevant paths.
    In particular, the mechanism housed in the water box allows the irrigation fluid to be routed between the irrigation modes and cleaning the canal with water (vigorous irrigation). As shown in the Figure, the water box outlet is connected (via the guide wire) to the distal spray head (26). Figure 3 presents a more detailed view of the working components of the proximal cable, including the external slider (32), which is connected to an internally located slider (34), whose purpose is to move an actuator, which in turn , causes the water valve (30) to rotate. In the example shown in this Figure, the valve is similar to the state of the art regulating valve.
    The channel on which the slider moves can be toothed so that the operator can receive the tactile feedback regarding the position of the slider (and therefore the current operating mode of the device). Figure 4 shows a detailed view of the water box (24) and its relationship with 68 Other main components of the cleaning device of the present invention.
    Consequently, the water valve (30) is located close to the inlet of the irrigation liquid (42), which receives the irrigation fluid pumped from a fluid reservoir or other externally located fluid source.
    This fluid inlet will then be directed (according to the position of the water valve lever) to one or both routes of the fluid channel: 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 the guide wire (14) inside the lumen of the
    E TP IP ET TE ID ET A IJ PO PO PTI IPO IP ED RAP EP EDP DP ETA TP TP TP DI E ED ET ED EP ET ED A 12/19 inner tube (16). A guide wire sealing element (44), such as an “O” ring) is incorporated into the device to prevent fluid loss around the guide wire (14), while allowing smooth axial movement of said guidewire through the water box (24). | 5 The routing of water and piping can be | configured in two main ways: | 1) irrigation through the lumen of the inner tube always open; 2) irrigation through the lumen of the inner tube, either open or closed.
    The first of these two modes ("always open mode") is illustrated in Figures 5A and 5B.
    Therefore, in Figure 5A, the lever of the water valve is positioned in such a way 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 tubes and external (channel B). This way of | irrigation is achieved when the operator pushes the slider forward (ie, distally) and then retracts slightly so that the | distal spray head rests on the distal outlet of the endoscopic working channel.
    Simultaneously, the actuator connected to the slider will move the water valve to the desired position, in which both channels A and B are placed in fluid communication with the irrigation fluid inlet.
    In this state, the irrigation fluid that is pumped distally through channels A and B will pass through the openings in the distal spray head in the form of a spray of fluids, which can be used to clean the body cavity region (colon, for example). example) which is found immediately after the distal end of the working channel.
    The device can then be switched from irrigation mode to vigorous suction mode (shown in Figure 5B) when the operator also retracts (ie, proximal movement) the external slider, such that the distal spray head is compressed more strongly against the exit of the distal working channel, Í
    | 13/19 thus closing the distal openings of the head, and therefore avoiding any transfer of additional fluid through said distal head.
    The corresponding movement of the actuator causes the valve to turn to a | position in which channel B is closed, while channel A remains in | 5 open position.
    In this mode, the pumped fluid passes through the lumen of the inner tube (ie, channel A). The negative pressure is then applied to a suction inlet on the proximal cable which (in this mode) is in fluid contact with channel B.
    In this way, the irrigation fluid that leaves the distal end of the lumen of the inner tube is aspirated proximally, through the space between the inner and outer tubes (channel B). The second of the main modes mentioned above is shown in Figure 6 - that is, the way in which the lumen of the inner tube can be in both the closed and the open state (in relation to the inlet of the irrigation fluid), according to the position of the water valve lever.
    The panel on the left of the Figure illustrates the situation in which channel A is open, thus allowing the irrigation fluid to pass distally through the lumen of the inner tube.
    On the right-hand panel, however, channel A is closed and channel B is open, the state of the inlet of the irrigation fluid being in fluid contact only with the space | 20 between the inner and outer tubes.
    Figure 7 illustrates the way in which | slider control by the operator is used to change the operating mode of the cleaning device of the present invention.
    Therefore, in panel A, the device is in the suction mode, in which the slider is in its most advanced position, and the negative suction pressure is applied to the space between the inner and outer tubes.
    The movement of the slider to a more proximal position takes the device to the irrigation mode, in which the irrigation fluid is pumped distally through the space between the inner and outer tubes (and in the 'always open' mode, also through the lumen Finally, the additional proximal movement of the slider brings the device into its vigorous suction mode, in which the irrigation fluid is pumped distally through the lumen of the inner tube against a
    | 14/19 distal head completely sealed and then aspirated proximally, through the space between the inner and outer tubes.
    Proximal cable - second embodiment: A second preferred embodiment of the proximal cable of the present invention will now be described in detail, with reference to Figures 8-11. This cable mode has an external shape similar to the first mode described above, and can be used to control the operation of a connected device in a similar way.
    There are, however, some important differences between the two modalities with regard, firstly, to the valve actuator and, secondly, to the internal arrangement of the water tank (also referred to here as a collector). Figure 8 shows a side view of the second preferred embodiment of the proximal cable of the present invention, having a collector (48) located at its distal end and an external slider (52) shown at its most distal position.
    Also shown is the externally positioned valve actuator stem (46), which replaces the internal slide actuator of the first mode described above and represented by the part number (34) in Figure 3. This actuator stem is shown in more detail in Figure 12, in which it can be seen that said rod is integrated 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 control external slide (52). It can also be seen that the distal end of the valve actuator stem (46) is integrated with a pair of jaws (70) oriented at right angles to the actuator stem itself, and said jaws are used to grip the movable end of the valve lever (50). Therefore, when the external slider (52) is pushed distally, the movable end of the valve lever (50) is similarly moved in a distal direction (as shown in Figure 8). Conversely, when the external slider (82) is pulled by the operator in a proximal direction, the movable end of the valve lever (50) is turned counterclockwise and, consequently, moved to its proximal position,
    as shown in Figure 9. It should also be noted that once the guide wire (53) of the colon cleaning device is connected to the slider (52), the movement of said slider distally or proximally will cause, respectively , the distal advance or proximal indentation of the distal obturator, which is connected to said guidewire.
    In this way, the movement of the external slider (52) can control two functions: the distal-proximal position of the distal plug of the connected cleaning device and the channeling of the irrigation fluid through the collector (48). As in the case of the first modality of the proximal cable presented and described here earlier, the second modality of the cable can be configured to operate in one or the other of the following two main modes, with respect to a colon cleaning device connected to said cable : 1) irrigation through the lumen of the inner tube always open; 2) irrigation through the lumen of the inner tube, either open or closed.
    The first of these two modes ("always open mode") is illustrated in Figures 10 and 11. Therefore, in Figure 10, the water valve lever (50) is positioned in such a way that the irrigation fluid (introduced through the inlet 54) is fluted simultaneously through two channels: the lumen of the inner tube (channel A; indicated by the numeral 56) and the space located between the inner and outer tubes (channel B; indicated by the numeral 64). This mode of irrigation is achieved when the operator pushes the external slider forward (that is, distally) and then moves back slightly, so that the distal spray head rests at the distal outlet of the endoscopic working channel.
    Simultaneously, the actuator connected to the slider will move the water valve to the desired position, in which the two channels A and B are placed in fluid communication with the inlet of the irrigation fluid (through a channel formed in the pivot of the water lever). water valve). In this state, the irrigation fluid that is pumped distally through channels A and B will pass through the openings in the distal spray head in the form of a spray of fluid that can be used to clean the body cavity region (for example, colon) which is found immediately after the distal end of the working channel.
    The device can then be switched from irrigation mode to vigorous suction mode (shown in Figure 11) when the operator also retracts (that is, proximal movement) the external slider, such that the distal spray head it is compressed more strongly against the outlet of the distal working channel, thus closing the distal openings of the head, and therefore preventing any further fluid transfer through said distal head.
    The corresponding movement of the actuator causes the valve to turn counterclockwise to a position in which channel B (indicated as 64 in Figure 10) is closed, while channel A (568) remains in the open position.
    In this mode, the pumped fluid that enters the collector through the fluid inlet (54) passes only through the lumen of the inner tube (i.e., channel A). The negative pressure is then applied to a suction inlet on the proximal cable which (in this mode) is in fluid contact and is channel B.
    In this way, the irrigation fluid that leaves the distal end of the lumen of the inner tube is aspirated proximally, through the space between the inner and outer tubes (channel B). It should be noted that this collector used in this preferred mode of the proximal cable incorporates several “O” rings (62) that are used to provide fluid sealing of the various components that are connected to it, such as, for example, internal tube (58 ), outer tube (60) and the guide wire (not shown). Although the mode described here immediately above (ie "always open inner tube" mode) is, for many applications, the preferred mode, it is also possible to configure the collector in such a way that the lumen of the inner tube can be both in the closed state , as in the open state (with respect to the irrigation fluid inlet), according to the position of the water valve lever.
    It should be noted that, while the collector (water box) of the second preferred modality is functionally very similar to the comparable element of the first modality, there are a number of differences in relation to the arrangement of the various channels within said collector. The inventors of the present invention have found that the channel arrangement used in the second embodiment is especially advantageous in relation to the set of tools needed during the manufacture of the device. Therefore, while several tools are required to manufacture the collector of the first modality, the second modality requires the use of only one tool.
    It should also be noted that, as previously mentioned, the proximal cable (in its various different modalities) that is presented and described here can be used in conjunction with several different elongated instruments, which are designed for insertion into a body passage (such as , for example, the colon). Therefore, in the description above of the fluid channeling inside the collector (water box) of the proximal cable, it should be understood that the "external tube" also includes other tubular structures in its scope, including, but not limited to, the wall | internal part of a body passage (such as the colon or other part of the gastrointestinal tract), and other unnatural tubular elements, such as the internal wall of an endoscopic channel (eg the working channel colonoscope).
    As explained earlier, the device of the present invention can be introduced into a passage of the body through the working channel of an endoscope, such as, for example, a colonoscope. In a preferred embodiment of such a case, the length of the guide wire and the inner and outer tubes is arranged in such a way that the proximal cable described above is located approximately 70 cm close to the proximal end of the endoscope. This arrangement allows the device to be held and manipulated by an assistant (for example, technician, nurse or assistant physician) standing or sitting at the aforementioned distance from the endoscope (and therefore the patient), thus allowing the main operator to perform their tasks. procedures in an unobstructed way.
    | The proximal cable in the shape of a shell can be made of ABS plastic, polycarbonate, Delrin and other plastic resins, depending on the compatibility with the sterilization method to be used (autoclave, gamma radiation or ETO), preferably by casting in mass production.
    The length of the casing can generally be approximately 80-120 mm, and the diameter of the fluid passages included therein can generally vary from 2-4 mm.
    The outer tube and the partial length inner tube can be made of ETFE, PTFE or other plastic resins that are compatible with the applicable sterilization method, with low friction coefficient and sufficient stiffness to support the device without collapse.
    In an alternative flexible configuration, the inner tube can be made of silicon or rubber resin, preferably PTFE to obtain less friction between the guide wire and the tube, as well as between the tube and the working channel, having a length of approximately 150-210 cm, depending on the length of the endoscope used, as well as the length of the outer tube, and having an inner diameter generally in the range of 1 mm, preferably smaller to reduce the effects of hysteresis (approximately AWG16) , and a wall thickness of approximately 0.25 mm to 0.4 mm.
    The guidewire is preferably made of 304V stainless steel with an optional PTFE coating configuration to reduce the potential friction between the wire and the PTFE inner tube and its diameter can generally range from 0.5-0, 7 mm, preferably approximately 0.8 mm.
    The partial-length inner tube is generally made of PTFE (for less friction) or ETFE, depending on the sterilization method of the device to be used, and has an outside diameter of approximately 1-1.6 mm and a wall thickness of approximately 0.25 mm.
    The outer tube can also be made from the materials mentioned above, and can have an outer diameter that generally ranges from 2-4 mm.
    However, both the inner and outer tubes can have diameters that differ considerably from these exemplary values, particularly when the device in which they are incorporated is intended for use in natural lumens or in instrumental lumens other than colonosocopic working channels.
    In any case, it should be contemplated that all the measurements mentioned above are given only as a general guide and in no way to limit the scope of the present invention.
    The device of the present invention can be part of a system that additionally includes a control console, an irrigation fluid pump (for example, diaphragm pump, peristaltic pump or a gear pump), a vacuum pump (for example, THOMAS diaphragm pump, piston pump), a transformer (eg MedicalWise MedicalWire 200W series medical transformer), safety timer, irrigation pump relay and vacuum pump relay, all of which are well known by experts in the art.
    The aforementioned additional equipment that can be used in conjunction with the device now presented can be conveniently contained within a discrete housing. This housing is connected by appropriate piping to a water tank used to supply the irrigation fluid to the cleaning device of the present invention. In a preferred embodiment, the device of the present invention can withstand irrigation pressures of up to 10 atmospheres and flow rates of approximately 1 liter / minute. The flow of the flushing fluid can be controlled by the operator by means of a foot switch electrically connected to the console. The console is also connected to the working channel of a colonoscope for the application of vacuum through it, using | a vacuum pump and aspirating waste, fecal material and other particles into a waste tank. | |
    权利要求:
    Claims (8)
    [1]
    1. COLON CLEANING DEVICE, characterized by the fact that it comprises at least one distal obturator having a proximal end and a distal end; - said obturator comprising channels, openings and / or nozzles that allow the passage of a fluid through them from said proximal end to said distal end; - said plug is connected to the distal end of an actuator element (such as, for example, a wire, tube, cord or rod); - at least an external portion of said distal obturator can be elastically deformed, such that the external contour or its diameter can be reduced in response to the internally directed compressive forces exerted thereon; - said channels, openings and / or nozzles being in a closed conformation when said distal obturator is subjected to the forces of compression and in an open conformation when said distal obturator is not subjected to said compression forces; - said device also comprising an internal tube of partial length around the actuator element in a coaxial manner, said tube extending from the proximal end of said actuator element and said length of said tube is less than the length said actuator element, such that a portion of the distal region of said actuator element is not bounded by said tube, and; - said device also comprising an outer tube of partial length around said inner tube in a coaxial manner.
    [2]
    2. DEVICE, according to claim 1, characterized by the fact that the actuator element is selected from the group consisting of a wire, a tube, a cable and a rod.
    [3]
    3. DEVICE, according to claim 2, characterized by the fact that the actuating element is a wire.
    [4]
    4. PROXIMAL CONTROL CABLE, characterized by the fact that it is suitable for use in conjunction with a device, according to claim 1, - the proximal ends of both the inner and outer tubes are connected to said cable; - the proximal end of the actuator element being connected in a mobile way to said cable; - said cable comprising means for changing the distance between said cable and the distal end of said actuator element; - said cable comprising switching means for directing the outlet of a fluid supply channel to one or more fluid outlet channels, and; - said cable comprising coupling means for coordinating the aforementioned switching between the fluid outlet channels with said means for changing the distance between said cable and said distal end of the actuator element.
    [5]
    5. PROXIMAL CABLE, according to claim 4, characterized in that the switching means comprise a multidirectional fluid valve.
    [6]
    6. PROXIMAL CABLE, according to claim 4, characterized in that the means for changing the distance between the proximal cable and the distal end of the actuator element comprise a sliding mechanism that is movably attached to the external surface of said cable, and the fact that said actuating element is connected to said sliding mechanism.
    [7]
    7. PROXIMAL CABLE, according to claim 6, characterized in that the coupling means comprise a mechanical actuator that is connected to both the sliding mechanism and the switching means.
    [8]
    PROXIMAL CABLE, according to claim 7, characterized in that the mechanical actuator is an elongated strip, a rod or a bar.
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    EN EO [MANTA Ce RS AI NAS A HER ll I AREA AE ESA RENA Es es DRA | | Nr SAAB NA ES and STE No ls ge o EN o RA VAR NEN DT) is IRENE OT Ne bo | EÉTE: RE) RESEATES SAIA LE RARA PST IATA ta A MBNVEEOAS S6 54 Figure 11
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    EAN ANA A NNE AND UNE AA A CO INTE ISRTOO ONE A AND a A 6B 52. 48 .. and To:. | 'Figure 12 f 111 o CHANGED SUMMARY:
    “COLON CLEANING DEVICE”. The present invention relates mainly to a body passage cleaning device that comprises at least one distally deformable plug elastically perforated by channels, openings and / or nozzles, said plug being connected to the distal end of an actuator element,
    and said device also comprising an inner tube of partial length which surrounds the actuating element in a coaxial manner, and an outer tube of partial length which, in turn, surrounds said inner tube in a coaxial manner.
    The present invention also includes a proximal control cable suitable for use with the aforementioned cleaning device.
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    公开号 | 公开日
    US9333287B2|2016-05-10|
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    AU2011210351B2|2014-07-31|
    US20110092892A1|2011-04-21|
    AU2011210351A1|2012-08-23|
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    WO2011092689A1|2011-08-04|
    JP5860410B2|2016-02-16|
    EP2528640A1|2012-12-05|
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    法律状态:
    2017-09-12| B12F| Other appeals [chapter 12.6 patent gazette]|
    2020-09-24| B15I| Others concerning applications: loss of priority|Free format text: PERDA DA PRIORIDADE DE 26/01/2010 US 61/298,265 POR NAO ENVIO DE DOCUMENTO COMPROBATORIO DE CESSAO DA MESMA CONFORME AS DISPOSICOES LEGAIS PREVISTAS NO ART. 16, 6O DA LEI 9.279 DE 4/05/1996 (LPI), ITEM 27 DO ATO NORMATIVO 128/1997, ART. 28 DA RESOLUCAO INPI-PR 77/2013 E ART. 3O DA IN 179/2017, UMA VEZ QUE O DEPOSITANTE CONSTANTE DA PETICAO DE REQUERIMENTO DO PEDIDO PCT E DISTINTO DAQUELE QUE DEPOSITOU A PRIORIDADE. |
    2020-10-06| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2021-02-09| B08F| Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]|Free format text: ARQUIVADO O PEDIDO DE PATENTE, NOS TERMOS DO ARTIGO 86, DA LPI, E ARTIGO 10 DA RESOLUCAO 113/2013, REFERENTE AO NAO RECOLHIMENTO DA 8A A 10A RETRIBUICAO ANUAL, PARA FINS DE RESTAURACAO CONFORME ARTIGO 87 DA LPI 9.279, SOB PENA DA MANUTENCAO DO ARQUIVAMENTO CASO NAO SEJA RESTAURADO DENTRO DO PRAZO LEGAL, CONFORME O DISPOSTO NO ARTIGO 12 DA RESOLUCAO 113/2013. |
    2021-07-20| B08K| Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]|Free format text: REFERENTE AO DESPACHO 8.6 PUBLICADO NA RPI 2614 DE 09/02/2021. |
    2021-11-23| B350| Update of information on the portal [chapter 15.35 patent gazette]|
    优先权:
    申请号 | 申请日 | 专利标题
    US29826510P| true| 2010-01-26|2010-01-26|
    US12/923,796|US9333287B2|2008-04-08|2010-10-07|Body passage cleansing device|
    US12/923,796|2010-10-07|
    PCT/IL2011/000086|WO2011092689A1|2010-01-26|2011-01-25|Colonic cleansing device|
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