JP2011518584A - Body passage cleaning device - Google Patents

Abstract

  The present invention is a body passage cleaning device suitable for passing through an internal channel of an endoscope, comprising a distal plug having a proximal end and a distal end, said plug passing through the interior thereof Including a channel, opening, and / or nozzle capable of allowing fluid to pass from the proximal end to the distal end, wherein the plug is connected to a distal end of a wire and is at least outside of the distal plug The portion can be elastically deformed such that its outer diameter is reduced in response to an inward radial compressive force applied thereto, and the channel, opening, and / or nozzle is Provided is a device that is closed when a plug is receiving the compressive force and open when the plug is not receiving the compressive force.

Description

  The present invention relates to an apparatus for cleaning the lumen of a colon or other body cavity through the working channel of an endoscope. More specifically, the device is configured to allow for optimal irrigation of body passages as well as massive aspiration of irrigation fluid and debris.

  During the endoscopic procedure, the physician manually manipulates the device by inserting a flexible endoscope and visualizing the internal pathway using the built-in camera. In colonoscopy, despite the use of various colonoscopy pre-cleaning procedures, the operator's field of view often shows fecal debris and other remaining in the colon lumen or other body passages Severely limited by the particulate matter.

  Various attempts have been made to provide procedures and means for cleaning the colon lumen prior to performing colonoscopy. The diagnostic accuracy and therapeutic safety of colonoscopy (as well as other diagnostic / therapeutic procedures such as virtual colonoscopy, sigmoid colonoscopy, barium enema, and capsule camera) can Depends largely on the quality of the pretreatment. An ideal pretreatment for colonoscopy is a process that is tolerated by the patient, cleans the intestine, and ensures that all fecal material is quickly removed from the colon without damaging the colon tissue. An ideal pretreatment also minimizes or eliminates any patient discomfort. Common pretreatments for lavage include a combination of food saving and laxative, polyethylene glycol pretreatment, gastrointestinal lavage, and phosphate pretreatment (oral sodium phosphate and tableted sodium phosphate). However, the use of each of these approaches has considerable limitations.

  By spraying the mucous membrane to remove bleeding, fecal residue, etc., flush the water over the gastrointestinal (GI) tract wall through the working channel and aspirate the liquid and residue through the working channel. Various attempts have been made to provide treatments and means for cleaning the colon lumen during endoscopic procedures. In certain endoscopes, in addition to the suction channel, there is another small channel (eg, 0.8 mm diameter) for irrigation. It has been found that cleaning fluid through the working channel and / or the smaller channel described above is not effective. Thus, when working channels are used for this purpose, the fluid does not have sufficient driving force to flush debris and is only effective for cleaning small bleeding areas and very soft stool . In the case of small channels, in principle, higher fluid propulsion can be achieved that can be used to remove fecal material, but only one point can be focused and to clean a larger area Such treatment is not effective because the endoscope head needs to be moved.

  In prior art methods, suction has been achieved using vacuum pressure through the working channel of the endoscope. This is relatively effective in aspirating liquid residues and / or extremely soft solid fecal material, but less effective in handling denser and stiff fecal material. In the past, the use of endoscopes with larger channels (up to 6 mm) has been proposed, but in addition to the suction channel limitation, the main limitation of suction is the suction pressure limited to 1 atm, so This solution is limited.

  In principle, endoscopes for both insertion of endoscopic accessories such as biopsy forceps, polypectomy snares, injection needles, nebulization catheters, and air insufflation and aspiration to assist in endoscope insertion It should be possible to use a working channel. This is further used for the passage of irrigation fluid to the area of the colon just distal to the distal end of the endoscope and for the suction and removal of said fluid together with fecal debris. However, when using the working channel of an endoscope, there is no driving force in irrigation because there is minimal resistance pressure and the introduced irrigation fluid has a very low effectiveness. One way to overcome this problem would be to use a catheter that is introduced into the working channel with a built-in nozzle at the distal end of the catheter to allow sufficient cleaning. However, the main drawback of such an approach is that the presence of an irrigation catheter in the working channel limits the available volume that can be used for aspiration. Furthermore, the restriction of the working channel volume will also impede the volume used for the passage of endoscopic equipment or for the insufflation and / or suction of air and the suction of debris.

  Thus, the main purpose of the present invention is through the endoscope working channel, while still allowing the use of the same working channel for other purposes, most specifically for the suction of fluid and debris from body cavities. It is to provide a device that enables effective and higher pressure irrigation of body cavities.

  A further object of the present invention is to allow irrigation and washing of the working channel of the device without removing the endoscopic device from the body so that blockage of the channel by fecal material and debris is prevented or eliminated. It is to provide an apparatus for performing.

  A further object of the present invention is to provide irrigation, lavage for other applications such as upper and lower GI bleeding, bronchoscopy, cystoscopy, gastrostomy surgery, where pretreatment and endoscopic surgery pretreatment are not possible. And providing a device that allows for suction. The main objective is to effectively irrigate and aspirate blood and clots with feces and debris without occluding the suction channels by clots and / or feces.

  It is a further object of the present invention to integrate all endoscopic devices with a nozzle assembly, thereby eliminating the need for instrument replacement (eg, biopsy forceps, snare, syringe needle, etc.) during the procedure. It is possible to improve the device.

  Further objects and objects will be explained as the description proceeds.

  We have used one working channel (or catheter or cannula etc.) of the endoscope for both passing irrigation fluid in the distal direction and aspirating fluid and debris in the proximal direction. Unexpectedly, both of these treatments can be performed very effectively as part of a procedure to clean the body passages and cavities. I found it.

The present invention firstly is a body passage washing device suitable for passing through an endoscopic channel, comprising a distal plug having a proximal end and a distal end, said plug passing through the interior thereof. Including channels, openings, and / or nozzles that allow fluid to pass from the proximal end to the distal end;
The plug is connected to the distal end of the wire;
At least the outer portion of the distal plug can be elastically deformed such that its outer diameter is reduced in response to an inward radial compressive force applied thereto,
The channel, opening, and / or nozzle is in a closed configuration when the distal plug is under the compressive force and is in an open configuration when the plug is not under the compressive force. Intended for body passage cleaning devices.

  It should be noted that for purposes of this disclosure, terms such as “distal spray head” may be used interchangeably with the term “distal plug”. Note also that the term “distal” refers to a direction away from the operator toward the center of the patient's body. Thus, the term “proximal” is taken to indicate the opposite direction.

  In a preferred embodiment of the present invention, the outer diameter of the distal plug when not subjected to an inward radial compressive force is slightly larger than the inner diameter of the endoscope working channel. In many cases, the inner diameter of the working channel in an endoscope is 3.8 mm, typically in the range of 2 to 4 mm.

  In a particularly preferred embodiment of the device, the elastically deformable part outside the distal plug is an O-ring.

In a particularly preferred embodiment of the device described above, the device further comprises a partial length tube coaxially surrounding the wire,
The tube extends from the proximal end of the wire;
The length of the tube is shorter than the length of the wire so that a portion of the distal region of the wire remains unenclosed by the tube.

In another particularly preferred embodiment, the device further comprises a proximal control handle,
The proximal end of the tube is connected to the handle;
The proximal end of the wire is movably connected to the handle;
The handle includes means for varying the distance between the handle and the distal end of the wire;
The handle includes one or more passages for connecting a fluid supply channel to one of the two or more fluid discharge channels;
The handle includes means for switching between fluid discharge channels to which the fluid supply channel is connected.

  Preferably, the proximal handle disclosed immediately above comprises one fluid discharge channel in fluid communication with the lumen of the partial length tube and a second fluid in fluid communication with the space surrounding the outer surface of the tube. An exhaust channel. When inserted into the working channel of the endoscope, this latter space is adjoined from the outside by the wall of the channel.

  Preferably, the means for changing the distance between the handle and the distal end of the wire includes a slider attached to the handle.

In another aspect, the present invention is a body passage cleaning device suitable for passing through an endoscopic channel, the distal head having a channel, opening, and / or nozzle formed therein. Including a spraying section,
The distal head spray is connected to the distal end of the collapsible catheter and the associated distal end of the stiffening wire;
The collapsible catheter provides a body passage washing apparatus that can adopt an expanded structure when a fluid stream passes through the interior and can adopt a folded structure when there is no fluid stream passing through the interior.

  In a preferred embodiment of this aspect of the invention, the collapsible catheter is a single lumen catheter. In another preferred embodiment, the catheter is a dual lumen or multilumen catheter.

In a further aspect, the present invention is a system for cleaning a body passageway:
a) an apparatus according to any one of the embodiments disclosed above and described in detail below;
b) a suction pump;
c) an irrigation pump;
d) A system is also provided that includes relays, transformers, and computer equipment for controlling the functions of the device and pump.

The present invention further provides a method of cleaning a body passageway:
a) inserting an elongate medical device into the body passage so that its distal end is located near and proximal to the region of the passage to be cleaned;
b) a channel, opening formed therein, through the internal channel of the elongate medical device such that the plug is placed over the distal outlet of the internal channel and in contact with the distal surface of the medical device Passing the portion and / or the distal plug to which the nozzle is attached;
c) Introducing irrigation fluid into the internal channel at a pressure sufficient to cause the fluid to form a spray or jet upon passing through the channel, opening, and / or nozzle formed in the distal plug. Steps,
d) causing the spray or jet to wash a region of the body passage located immediately distal to the end of the channel;
e) moving the distal plug in a distal direction such that there is no contact between the plug and the distal surface of the elongate medical device in the body passageway;
f) applying a negative pressure to the proximal end of the internal channel of the elongated medical device to cause suction of fluid and solid particulate matter through the internal channel;
g) if necessary, returning the distal plug to the position defined in step (b) and repeating steps (c) to (f).

  In certain preferred embodiments of the method, the elongate medical device is an endoscope and the internal channel is a working channel contained therein. In a particularly preferred embodiment, the endoscope is a colonoscope and the body passage to be cleaned is part of the large intestine.

  In a preferred embodiment of this method, the distal plug described above is attached to a guide wire.

In a particularly preferred embodiment of the method, the guidewire is surrounded (coaxially) by a partial length tube extending distally from the proximal end of the guidewire, the length of the tube being It is shorter than the length of the wire so that a portion of the distal region of the wire remains unenclosed by the tube. In a particularly preferred embodiment of this version of the method, the method comprises:
i) retracting the distal plug into the distal end of the inner channel such that the plug is radially compressed, thereby reducing its outer diameter, thereby sealing the distal end of the inner channel. When,
ii) when fluid leaves the distal end of the tube, the positive fluid pressure supplied thereby assists in preventing or eliminating blockage in the distal portion of the internal channel of the elongated medical device. Introducing irrigation fluid into the lumen of the long tube.

The present invention further provides a method for cleaning a body passageway comprising:
a) inserting an elongate medical device into the body passage so that its distal end is located near and proximal to the region of the passage to be cleaned;
b) passing a device comprising a distal head spray section formed therein with a channel, opening, and / or nozzle attached into the internal channel of the elongate medical device, wherein The distal head spray is connected to the distal end of the collapsible catheter and the associated distal end of the stiffening wire such that the distal head spray is positioned beyond the distal outlet of the internal channel; Steps,
c) within the lumen of the collapsible catheter with sufficient pressure to cause the fluid to form a spray or jet upon passing through channels, openings, and / or nozzles formed in the distal spray head. Introducing an irrigation fluid into the
d) causing the spray or jet to wash the region of the body passage where the distal spray head is located;
e) closing the supply of irrigation fluid to the lumen of the collapsible catheter so that the wall of the catheter is folded, thereby reducing the volume of the internal channel occupied by the catheter; Optionally applying a negative pressure to the lateral opening;
f) applying a negative pressure to the proximal end of the internal channel of the elongated medical device to cause suction of fluid and solid particulate matter through the internal channel;
and g) repeating steps (c) to (f) if necessary.

  Other advantages and features of the invention will become apparent as the description proceeds.

The present invention is illustrated by way of example in the accompanying drawings in which like reference characters refer to like elements throughout.
The embodiments illustrated in the drawings are not intended to be drawn to scale, and are in a schematic form for easy understanding and explanation.

1 schematically illustrates a preferred embodiment of a single lumen folding catheter of the present invention. 2 schematically illustrates one embodiment of a single lumen folding catheter shown in FIG. 1 having a control wire and a flexible coupled wrap ring. Fig. 3 schematically shows the catheter shown in Fig. 2 when introduced through the working channel of an endoscope. 1 shows an irrigation tube according to the prior art. 1 shows a colonoscope according to the prior art. FIG. 2 schematically shows a cross-sectional view of an embodiment of a foldable tube of the present invention in an expanded state with a hardened wire attached to the exterior. FIG. 2 schematically shows a cross-sectional view of an embodiment of a foldable tube of the present invention in a folded state with a hardened wire attached to the exterior. FIG. 2 schematically shows a cross-sectional view of an embodiment of a foldable tube of the present invention in a folded state with a curing wire attached therein. FIG. 2 schematically illustrates a cross-sectional view of an embodiment of a foldable tube of the present invention in an expanded state with a curing wire attached therein. FIG. 2 schematically shows a cross-sectional view of a multilumen catheter having a foldable inner wall with the inner wall in a folded state. FIG. 2 schematically shows a cross-sectional view of a multilumen catheter having a foldable inner wall with the inner wall in an expanded state. FIG. 6 schematically shows a perspective view of a dual lumen embodiment with a partially folded inner wall. FIG. 6 schematically shows a perspective view of an embodiment of a dual lumen with a partially folded inner wall, through which a series of openings are perforated. Fig. 4 schematically illustrates an irrigation catheter of the present invention in which a deflated balloon is employed to control the irrigation mode. Fig. 4 schematically illustrates an irrigation catheter of the present invention in which an inflated balloon is employed to control the irrigation mode. Fig. 3 schematically illustrates a distal spray head embodiment of the present invention employing a sliding overtube to control jet spray in a recently positioned state. FIG. 6 schematically illustrates a distal spray head embodiment of the present invention employing a sliding overtube to control jet spray in a partially coated state. Fig. 4 schematically illustrates a distal spray head embodiment of the present invention employing a sliding overtube to control jet spray in the farthest position. Figure 7 schematically illustrates a distal spray head embodiment employing a rotating overtube to control jet spray in an inconsistent state. FIG. 6 schematically illustrates a distal spray head embodiment employing a rotating overtube to control jet spray in a partially overlapping state. Figure 7 schematically illustrates a distal spray head embodiment employing a rotating overtube to control jet spray in a precisely aligned state. Figure 7 schematically illustrates a distal spray head embodiment of the present invention that utilizes a removal spring. FIG. 6 schematically illustrates a perspective view of a distal spray head embodiment configured to direct the flow of irrigation fluid in the direction of convergence. FIG. 6 schematically illustrates a cross-sectional view illustrating the flow through the interior of a distal spray head embodiment configured to direct the flow of irrigation fluid in the direction of convergence. FIG. 6 schematically illustrates a cross-sectional view illustrating the flow through the interior of a distal spray head embodiment configured to direct the flow of irrigation fluid in the direction of convergence. FIG. 6 schematically illustrates a cross-sectional view illustrating the flow through the interior of a distal spray head embodiment configured to direct the flow of irrigation fluid in the direction of convergence. FIG. 4 shows a cross-sectional view of a distal spray head embodiment of the present invention configured to direct the flow of irrigation fluid in a converging direction with a preset internal nozzle angle. FIG. 6 schematically illustrates a perspective view of a distal spray head embodiment of the present invention configured to provide divergent flow. FIG. 6 schematically illustrates a cross-sectional view illustrating the flow through the interior of a distal spray head embodiment of the present invention configured to provide divergent flow. FIG. 6 schematically illustrates a cross-sectional view illustrating the flow through the interior of a distal spray head embodiment of the present invention configured to provide divergent flow. FIG. 6 schematically illustrates a cross-sectional view illustrating the flow through the interior of a distal spray head embodiment of the present invention configured to provide divergent flow. Fig. 6 schematically illustrates a distal spray head embodiment of the present invention configured to provide divergent flow with a preset internal nozzle angle. Figure 2 shows a perspective view of a preferred embodiment of the distal spray head of the present invention. Fig. 3 schematically illustrates an embodiment of the irrigation catheter of the present invention including a filter attached to the distal portion of the catheter tube. Fig. 4 schematically illustrates an embodiment of the irrigation catheter of the present invention comprising a catheter and a filter when introduced through a colonoscope. FIG. 3 shows a front perspective view of a preferred embodiment of the distal head portion of the present invention in a “closed” configuration. FIG. 6 shows a rear perspective view of a preferred embodiment of the distal head of the present invention in a “closed” configuration. FIG. 20C shows a rear perspective view of the distal head portion shown in FIG. 20B in a conical / frustum structure. FIG. 20B shows a front perspective view of the distal head portion shown in FIG. 20A in a conical / frustum structure. FIG. 20B shows a front perspective view of the distal head portion shown in FIG. 20A in a second frustoconical configuration. FIG. 20C shows a rear perspective view of the distal head portion shown in FIG. 20B of a second frustoconical structure. FIG. 23 shows a perspective view of the spray head shown in FIGS. 20 and 22 in irrigation mode when positioned over the working channel outlet opening. FIG. 23 shows a front view of the spray head shown in FIGS. 20 and 22 in irrigation mode when placed above the exit opening of the working channel. FIG. 4 shows a side view of a spray head portion of a preferred embodiment of a spray head portion comprised of a flexible plug disposed above an internal rigid element. FIG. 4 shows a cross-sectional view of a spray head portion of a preferred embodiment of a spray head portion comprised of a flexible plug disposed above an internal rigid element. FIG. 4 shows a cross-sectional view of the spray head portion as it travels through the working channel of a preferred embodiment of a spray head portion comprised of a flexible plug disposed above the internal rigid element. Sectional view of the spray head portion in irrigation mode, located above the outlet opening of the working channel, of a preferred embodiment of the spray head portion comprised of a flexible plug placed above the internal rigid element. Indicates. A top view of the spray head portion in irrigation mode, located above the outlet opening of the working channel, of a preferred embodiment of a spray head portion comprised of a flexible plug placed above the internal rigid element. Indicates. One preferred embodiment of a spray head composed of a flexible plug disposed above an internal rigid element, when pulled back into the working channel to sealably seal the internal passage Sectional drawing of a spray head part is shown. Fig. 4 illustrates an exemplary mechanism that may be used with the apparatus of the present invention for removal of solid debris. Fig. 4 illustrates an exemplary mechanism that may be used with the apparatus of the present invention for removal of solid debris. Fig. 4 illustrates an exemplary mechanism that may be used with the apparatus of the present invention for removal of solid debris. A possible suction method using the device of the invention is schematically shown. Fig. 2 schematically shows a front view of a deflated balloon of a preferred embodiment of the present invention in which a spray head is provided in the form of a small balloon. 1 schematically illustrates an inflated balloon of a preferred embodiment of the present invention in which a spray head portion is provided in the form of a small balloon. Fig. 4 schematically shows a balloon in an inflated state in a working channel of a preferred embodiment of the invention, where the spray head is provided in the form of a small balloon. Fig. 2 schematically shows a balloon in a deflated state in a working channel, a preferred embodiment of the present invention in which a spray head is provided in the form of a small balloon. Fig. 4 schematically shows an embodiment of a spray head part provided in the form of a flexible mushroom valve in a reduced state. Fig. 4 schematically shows an embodiment of a spray head part provided in the form of an expanded flexible mushroom valve. Fig. 5 schematically shows an embodiment of a spray head provided in the form of a flexible mushroom valve, showing possible mounting nozzles in the flexible mushroom valve. Fig. 5 schematically shows an embodiment of a spray head provided in the form of a flexible mushroom valve, showing possible mounting nozzles in the flexible mushroom valve. Fig. 5 schematically illustrates an embodiment of a spray head provided in the form of a flexible mushroom valve, showing the flexible mushroom valve when expanded by the flow of irrigation fluid. 1 schematically illustrates a distal spray head portion of the present invention including biopsy forceps. 1 schematically illustrates a distal spray head portion of the present invention including biopsy forceps. 1 schematically illustrates a distal spray head portion of the present invention including biopsy forceps. 1 schematically illustrates a distal spray head portion of the present invention including biopsy forceps. 1 schematically illustrates a distal spray head portion of the present invention including biopsy forceps. Fig. 6 illustrates a possible embodiment in which a hollow wire or tube is used, wherein the deflector is mounted on the wire / tube of the catheter device, further comprising a cleaning opening. Fig. 6 schematically shows a possible embodiment in which the deflector is mounted on the wire / tube of the catheter device. Fig. 2 schematically shows a cleaning device of the present invention when introduced through an endoscope / colon endoscope working channel. FIG. 4 shows a perspective view of a particularly preferred embodiment of the cleaning device in the working channel of the endoscope / colon endoscope, with the rear portion of the distal spray portion located at the distal end opening of the working channel. FIG. 4 shows a perspective view of a particularly preferred embodiment of the cleaning device in the working channel of the endoscope / colon endoscope, with the distal spray part located completely outside the working channel. FIG. 4 shows a perspective view of a particularly preferred embodiment of a cleaning device in the working channel of an endoscope / colon endoscope in which a majority of the distal spray section is sealably disposed in the working channel. FIG. 25 shows a front view of the spray head in irrigation mode, located above the outlet opening of the working channel, of the spray head shown in FIG. 24 in irrigation and suction mode. FIG. 25 shows a perspective view of the spray head part in irrigation mode, located above the outlet opening of the working channel, of the spray head part shown in FIG. 24 in irrigation and suction mode. FIG. 25 shows a perspective view of the spray head shown in FIG. 24 in irrigation and suction mode, showing the state of the spray head in suction mode, being advanced further distally from the working channel outlet opening. Fig. 4 shows a preferred embodiment of the present invention where the catheter device includes a nozzle and a sealing balloon, showing the catheter device in the working channel when both balloons are in a deflated state. Fig. 4 illustrates a preferred embodiment of the present invention where the catheter device includes a nozzle and a sealing balloon, showing the catheter device in the working channel in irrigation mode with the nozzle balloon in an inflated state and the sealing balloon in a deflated state. Fig. 4 illustrates a preferred embodiment of the present invention where the catheter device includes a nozzle and a sealing balloon, showing the catheter device in the working channel in an irrigated state with the nozzle balloon in an inflated state and the sealing balloon in a deflated state. Fig. 4 shows a preferred embodiment of the present invention, where the catheter device includes a nozzle and a sealing balloon, showing the catheter device in the working channel in suction mode with both balloons in a deflated state. Fig. 4 illustrates a preferred embodiment of the present invention where the catheter device includes a nozzle and a sealing balloon, showing the catheter device in the working channel in the wash mode with the nozzle balloon in a deflated state and the sealing balloon in an inflated state. 1 is a block diagram illustrating one possible type of suction system of the present invention. FIG. Fig. 4 schematically shows the change of the operating mode of the device of the present invention by the proximal control handle and shows the setting of the device to the irrigation mode by the handle part. Fig. 6 schematically shows the change of the operation mode of the device of the present invention by the proximal control handle, and shows the setting of the device to the suction mode by the handle part. Fig. 6 schematically shows the change of the operation mode of the device of the present invention by the proximal control handle and shows the setting of the device to the cleaning mode by the handle part. Fig. 4 schematically shows a change of the operating mode of the device of the present invention by the proximal control handle, schematically showing a proximal control handle further including a trigger for setting the device to a removal operating mode. Figure 7 schematically illustrates an embodiment of a distal spray head of the present invention that allows control of the angle of the spray jet and demonstrates the adjustment of the distal spray head to provide a wide angle forward spray. Figure 7 schematically illustrates an embodiment of a distal spray head of the present invention that allows control of the angle of the spray jet and demonstrates the adjustment of the distal spray head to provide a narrow angle forward spray. Figure 7 schematically illustrates an embodiment of a distal spray head of the present invention that allows control of the angle of the spray jet and demonstrates the adjustment of the distal spray head to provide a side spray. Fig. 4 schematically shows an embodiment of the catheter device of the present invention, wherein the sealing of the distal end of the endoscope working channel is achieved by a balloon mechanism, showing the device in a deflated state. Fig. 4 schematically shows an embodiment of the catheter device of the present invention, wherein the sealing of the distal end of the endoscope working channel is achieved by a balloon mechanism, showing the device with the balloon in an inflated state. Fig. 4 schematically shows an embodiment of the catheter device of the present invention, wherein the sealing of the distal end of the endoscope working channel is achieved by a balloon mechanism, showing the device with the balloon in an inflated state. FIG. 6 is a block diagram illustrating a possible implementation of a console for operation of the cleaning apparatus of the present invention. Fig. 4 schematically illustrates a preferred embodiment of the proximal control handle, showing the state of the proximal control handle in the irrigation mode of operation. Fig. 4 schematically illustrates a preferred embodiment of a proximal control handle, showing the state of the proximal control handle in a working channel removal mode of operation.

  The present invention is directed to the technical aspects described above that are faced when using an endoscopic working channel for both irrigation of body passageways (such as the colon) and massive aspiration of irrigation fluid (with removed solid and semi-solid debris). Provides two main solutions to the problem. In the first of these two approaches, the device of the present invention uses a large irrigation lumen (when unfolded) and a large suction lumen when the catheter is folded (ie, working channel volume). Built-in folding catheter that provides both.

  In the second approach, the device includes a novel distal plug / spray head mounted at the distal end of the guidewire. In one highly preferred embodiment of this approach, as will be described later, the device of the present invention extends from the proximal end of the guidewire and terminates a few centimeters before the distal end of the guidewire. A partial length unfoldable catheter or sheath. This partial length tube is most often unfoldable, but in some embodiments it may be provided in the form of a collapsible catheter. As explained further below, this unique structure prevents optimal irrigation and aspiration of the body cavity being treated or cleaned, and occlusion of the endoscopic working channel that would otherwise occur during the cleaning process And combine with the ability to resolve.

Folding Catheter Approach Two main embodiments of the folding catheter device are described below. Single-lumen catheters and multi-lumen catheters.

First Main Embodiment: Single-lumen Folding Catheter The first embodiment includes a device that is introduced into the working channel of the endoscope to clean the colon. As shown in FIG. 1, an irrigation (or irrigation) catheter 1 includes a collapsible sheath 1c and a metal (eg, stainless steel or aluminum) hardening wire 1b. The distal end of the sheath is fluidly connected to a jet spray head 1a fitted with a nozzle 1d capable of directing irrigation fluid spray, as will be described in more detail later. The purpose of the distal end of the stiffening wire 1b connected to the spray head 1a is to insert and advance the catheter 1 even when the sheath is in a relaxed and folded state. In order to assist the operator in guiding the apparatus of the present invention, the curing wire 1b may contain one or more radiopaque materials at various locations along its length (see FIG. Not shown). These radiopaque markers may be used to locate the device by real-time visualization using X-ray imaging. The use of such markers is particularly important in upper GI endoscopic procedures, for example when introducing endoscopic instruments through the nipple.

  The proximal end of the catheter is connected to an irrigation fluid source (eg, saline) and a suitable pump device as shown in FIG. When this irrigation fluid is pumped through the catheter 10, the collapsible sheath accepts its fully expanded structure, thereby allowing maximum transfer of the irrigation fluid to the jet spray head 1a. When the irrigation fluid is interrupted from flowing through the catheter (eg, as a result of turning off the irrigation fluid pump and connecting the proximal end of the sheath to a negative pressure source), the collapsible sheath has its structural rigidity source (irrigation fluid). Column) and return to its relaxed folded state, thereby increasing the volume of the working channel outside the irrigation catheter. This is very advantageous for at least the following three reasons.

a) maximum space is provided for aspiration of irrigation fluid and fecal debris through the working channel;
b) additional space for introduction and passage of endoscopic surgical instruments is created (without the need to remove the irrigation catheter), and c) air delivery of body cavities (eg colon) in the presence of a folded catheter May be executed.

  If the collapsible sheath of the present invention is not present, it may be necessary to completely remove the irrigation catheter from the working channel before aspirating it or inserting an endoscopic instrument therein. Thus, the folding catheter of the present invention has the obvious advantage of eliminating the need for tedious and labor intensive removal and reinsertion of the catheter several times during the cleaning procedure.

  As shown in FIG. 2, this embodiment of the device of the present invention is also for orienting the head during irrigation and aspiration when the distal jet spray head 1a is moved away from the distal outlet of the working channel. A control wire 1e may be further included. The distal end of the control wire 1e is connected to the jet spray head 1a, while the proximal end remains outside the patient's body (optionally a control handle, as commonly used in endoscopic procedures). Terminated within).

  Although the curing wire 1b may not be connected to the foldable sheath 1c, in one embodiment of the present invention, the wire and the sheath may include a plurality of flexible coupled wrapping rings 1f as shown in FIG. May be connected to each other or inserted inside the collapsible tube.

  Referring to FIG. 3, as described above, the irrigation catheter 1 is inserted into the proximal end of the working channel 3c of the endoscope 3e, and the distal end of the catheter leaves the working channel and leaves the colon lumen. Is advanced distally until it enters.

  FIG. 4A shows a simple irrigation tube according to the prior art having a lumen 4c approximately 1 to 3 mm in diameter passing through the 3.8 mm diameter working channel of the conventional colonoscope 4a shown in FIG. 4B. It is sectional drawing. It can be seen that this unfolding catheter occupies a significant proportion of the available cross-sectional area (and thus the volume) of the working channel 4b.

  5A and 5B are in an expanded configuration in FIG. 5A connected to a relatively small diameter (eg, 0.25 to less than 0.6 mm) rigid metal wire 5e that passes through the working channel 5b. 5B is a cross-sectional view of an embodiment of the present invention showing a foldable tube 5d in a folded state (5d ′) in 5B. FIG. 5A shows the catheter 5 in an expanded state, ie when irrigation fluid is pumped through the sheath, to clean a body cavity (eg, the colon). When negative pressure is applied to the proximal end of the sheath, it collapses and contracts (5d '), as shown in FIG. 5B. A check valve may be used for optimal folding.

  In order to pump irrigation fluid into the sheath, the device may be connected to a positive pressure fluid pump (centrifugal, peristaltic, etc.) or to a manual injector. To fold the sheath, it can be connected to a manual injector or through a negative pressure vacuum pump.

  An additional advantage of the present invention is that it allows the use of larger diameter irrigation catheters, thereby reducing tube resistance and thus the use of irrigation pumps that produce lower pressures while maintaining the same water jetting power. Is to do.

  FIGS. 6A and 6B show that a metal-cured wire 6e (eg, having a diameter of about 0.25 mm to 0.6 mm) is located inside the folded sheath 6d (shown in FIG. 6A in the folded state 6d ′). , And thus an alternative configuration passing through the working channel 6b. As the irrigation fluid is pumped through the sheath under positive pressure, the fluid is directed to the body cavity being cleaned (eg, the colon). Conversely, when a negative pressure source is connected to the proximal end of the device, the sheath is folded (6d 'in FIG. 6A), thereby creating a larger free volume in the working channel 6b. A check valve may be used to form an optimal sheath fold.

  The collapsible irrigation catheter 6 may be composed of non-compliant materials such as nylon, Pebax (or mixtures thereof), polyurethane, and preethylene terephthalate (PET). In such a case, the empty (ie, drained) sheath has an arbitrary flat shape (6d '), and when expanded with irrigation fluid, this cross-section becomes circular (6d in FIG. 6B). In another embodiment, the collapsible catheter may be made of a compliant material such as silicone or thermoplastic elastomer (TPE), which can be expanded in the same manner as a compliant balloon.

Second Main Embodiment: Multilumen Folding Catheter The second embodiment likewise includes a device suitable for passing through the working channel of the endoscope. However, in contrast to the first embodiment described above, the device of this embodiment includes a multilumen catheter tube, of which at least one wall of at least one lumen is foldable. The multilumen tube is fluidly connected through at least one of its lumens to a jet spray head disposed at the distal end of the tube. In a preferred embodiment, the multi-lumen tube is a dual-lumen tube and one lumen is suitable for passing irrigation fluid forward (ie, distally) toward the jet spray head described above. While the second lumen may be used as a “virtual working channel”, which sucks and removes fecal debris and passes through endoscopic instruments (forceps, baskets, polypectomy devices, etc.) May be used for many purposes, including

  7A and 7B show an exemplary and preferred embodiment of the dual lumen catheter tube 7 of the present invention. These drawings provide a cross-sectional view of a dual lumen catheter 7 placed within the lumen of the working channel of the colonoscope 7d, where the inner wall 7s is a larger “virtual working channel” (or suction). The lumen 7a is separated from the smaller irrigation lumen 7b. In FIG. 7B, the irrigation lumen 7b is shown in an expanded state, i.e., filled with an irrigation fluid (such as saline). In FIG. 7A, the irrigation lumen is shown in a folded state (7b ') after the irrigation fluid has been removed from the lumen by a negative pressure source connected to its proximal end. From FIG. 7A, when the irrigation lumen 7b ′ is in a folded state, the inner wall contracts (7s ′) and the larger suction (or “virtual working channel”) lumen 7a ′ has a much larger volume, thereby It will be seen that this lumen performs the intended function (aspiration and / or passage of surgical instruments) more effectively.

  In a preferred embodiment, the collapsible wall of the multilumen conduit may be constructed of a flexible, non-compliant material (eg, nylon or Pebax). Alternatively, the foldable wall may be made of a compliant material, such as silicone rubber.

  A perspective view of the dual lumen embodiment 8 is shown in FIG. 8, with the irrigation lumen inner wall 8s in a partially folded state.

  An alternative embodiment of the dual lumen catheter 9 of the present invention is shown in FIG. 9 in which the inner wall 9s (also referred to as a dual lumen septum) of the irrigation lumen is penetrated by a series of openings 9p. . The opening 9p allows a portion of the irrigation fluid to pass from the smaller irrigation lumen 9b into the larger suction lumen 9a. The irrigation fluid flowing through the opening 9p supports the destruction of fecal material sucked into the suction lumen 9a. This further destruction of the particulate material helps inter alia prevent occlusion of the suction lumen 9a and the negative pressure line and the device connected to its proximal end.

  The multilumen catheter tube of the present invention may be manufactured by incorporating an internal septum within a single tube or by connecting two or more single lumen tubes side by side.

Control of distal jet spraying In addition to providing an external collapsible conduit (first main embodiment) or an internal collapsible conduit (second main embodiment), allows expansion of the suction (or virtual working channel) lumen For purposes of the present invention, the present invention also provides various novel solutions for the control of irrigation jet spray through the distal spray head and the portion of the catheter located just proximal to the distal spray head. .

  FIG. 10A schematically illustrates the distal spray head region of one preferred embodiment of the present invention. Although generally similar to the first main embodiment described above (and described in FIGS. 1-6), the presently described embodiment also includes a number of additional features. Thus, referring to FIG. 10A, the distal spray head g1 appears to include a plurality of spray nozzles g3 at its distal portion. The rigid wire g6, in the presently described embodiment, is in fluid contact with the balloon g2 at its distal tip, and with an inflation fluid source and pumping device (not shown) at its proximal tip. It differs from that described above in that it has a lumen that is in fluid contact. Adjacent to the distal head on its proximal side is a sleeve g7 with a series of side openings g4. The foldable catheter sheath g10 is attached to the sleeve g7 with biocompatible glue (for example, UV glue), and further mechanically attached with a pressure ring (g5). Thus, when it is desired to direct the jet spray in the forward (distal) direction, the balloon g2 remains in an uninflated state, thereby causing the distal spray nozzle g3 and the side opening as shown in FIG. 10A. Allows free flow of irrigation fluid through both g4.

  However, if the operator wishes to eject the jet spray only through the side opening g4, the balloon g2 is inflated to occlude the distal jet opening g3, as shown in FIG. 10B. Be made. The operator may choose to pump the irrigation fluid distally through the catheter for an extended period of time, while inflating and deflating the balloon g2 from time to time to direct the fluid as needed. Alternatively, during irrigation, the balloon can be inflated / deflated at a high frequency (eg, up to 10-20 Hz), thereby applying an oscillating force to the irrigation fluid, thus enhancing the cleaning operation.

In a further preferred embodiment, the device of the present invention is further adapted to occlude the aforementioned side opening, thereby permitting or preventing an irrigation fluid jet spray exiting this side opening. Including means for These means may be used in combination with the balloon elements described above, whereby i. Only the distal spray nozzle,
ii. Distal spray nozzle and lateral opening, or iii. Allows selection of jet spray through only the side openings.

  Alternatively, the device may include only lateral occlusion means. That is, the above-described balloon element is not incorporated.

  In a preferred embodiment, the side opening occlusion means comprises a slidable overtube (11t) attached around the catheter tube (11c) in the region of the side opening (11p). 11A to 11C schematically show three different positions of the overtube 11t relative to the opening 11p. Thus, in FIG. 11A, the overtube 11t is in the most proximal position, thereby exposing all of the side openings 11p, thus allowing jet spray to be emitted from the distal side of the catheter tube. To do. In FIG. 11B, the overtube 11t has been moved to partially cover the side opening 11p, thereby reducing the area of the distal portion of the catheter that is available to release the jet spray. Finally, in FIG. 11C, the overtube 11t is retracted to the most distal position, thereby completely closing all of the side openings 11p.

  In an alternative embodiment, as shown in FIGS. 12A-12C, the rotatable overtube h2 (rather than slidable) corresponds exactly to the opening h1 present in the catheter tube h3, A series of side openings h4 of its own are provided. For this reason, in FIG. 12A, the rotatable overtube h2 is positioned so that its opening h1 is not aligned with the side opening h4 of the catheter tube h3, thereby the side opening h1. Prevent any jet spray from being released. However, in FIG. 12B, the overtube h2 is rotated to an intermediate position so that the two sets of openings h1 and h4 partially overlap and follow a series of reduced area jet spray channels. Finally, FIG. 12C shows that the opening h1 is accurately aligned with the side opening (h4, not shown) of the catheter tube h3, thereby allowing the maximum amount of jet spray to pass through the opening. The state after the tube h2 is further rotated is shown.

One of the main advantages provided by the nozzle occlusion mechanism described above is that the suction and irrigation operations may be performed independently (together or separately), which allows for greater flexibility in liquid utilization and higher efficiency. It is possible. as a result,
When it is necessary to irrigate the colon, it is desirable to have maximum propulsion of the flow through the distal spray head. In such cases, the side openings are blocked,
When fecal material needs to be aspirated through the working channel, it is desirable that the spray jet be concentrated laterally in order to achieve maximum fecal destruction and dilution while passing through the working channel.

  It should be noted that the aspiration and dilution of fecal material using the side openings is performed continuously (functioning with the catheter sleeve in the “expanded” state with the side openings exposed). Aspirated diluted / destroyed stool). Alternatively, switch between aspiration and lateral opening spray so that the catheter sleeve is folded (due to application of internal negative pressure) and then expanded again each time aspiration is performed to cause fecal destruction It is possible. This process is then repeated until the desired result is obtained.

In other preferred embodiments of the present invention, the following two configurations may be used individually or together to increase the efficiency of aspiration of destroyed fecal material:
1) Use a jet spray emanating from a side opening to destroy feces aspirated through the working channel.
2) Use a spring-like configuration made of a thin wire mesh that employs a high frequency 20-50 Hz linear motion to remove feces in a manner similar to a food processor.

  The second of the two configurations is schematically shown in FIG. 13 which shows a possible embodiment employing spring-like thin wire meshes q1 and q2.

  The present invention also includes a distal spray head that is capable of directing the flow of irrigation fluid inwardly or outwardly.

Inward Direction of Flow The configuration shown in FIGS. 14A-14D may be used to direct the flow of irrigation fluid from the distal spray head p4 in a predetermined convergence (ie, inwardly directed) direction. . The flow p6 may pass through the optimization entrance p3 in order to avoid local turbulence. The flow p6 is then passed through a fine nozzle p1 (for example having a diameter of about 0.2 to 0.4 mm) and finally flows across the surface of the nipple p2 using the surface tension principle, whereby the spray head discharged from p4. Substantially all of the irrigation fluid is thus oriented inward toward the concentration point p5.

  In an alternative configuration, as shown in FIG. 15, the flow p6 may be oriented with a preset internal nozzle angle p7.

Flow Outward Direction The configuration shown in FIGS. 16A-16D may be utilized to divergently direct the flow from the distal spray head y4. Flow y6 may pass through an optimization portal designed to avoid local turbulence. The flow y6 is then passed through a fine nozzle y2 (for example having a diameter of about 0.2 to 0.4 mm) and finally flows across the surface of the nipple y1 using the surface tension principle, so that the spray head It is discharged from y4. As shown in FIG. 16D, substantially all of the irrigation fluid is thus divergently oriented.

  In an alternative configuration, as shown in FIG. 17, the flow y6 may be oriented with a preset internal nozzle angle y8.

  FIG. 18 illustrates one preferred embodiment of a distal spray head that may be used as part of the present invention. This particular version of the spray head includes a combination of jet spray openings (8a, 8b, 8c, 8d, 8e) arranged at different locations along the surface of the head and angled in various directions. The openings and nozzles labeled in the figure are as follows.

A. A forward-directing jet (via opening 8a) to clean the rectal lumen (or other body cavity) distal to the leading edge of the device;
B. A jet nozzle 8b oriented at an angle other than 90 degrees relative to the distal surface of the device (eg, angled outwardly toward the rectal wall),
C. Radially outwardly directed jet 8c,
D. The force of the irrigation water provides sufficient force to rotate the ring containing the inclined opening 8d and thus propel the cleaning solution in the radial direction.
E. Backward-directed jet (via opening 8e) for device advancement or destruction of fecal material just prior to being aspirated through the working channel and / or cleaning of the endoscope lens and illumination LED.

Filtration and destruction / dilution of fecal material In another preferred embodiment, as shown in FIGS. 19A and 19B, the apparatus may further include a filter portion 9c attached to the distal portion of the catheter tube 9g. The filter 9c can block any material larger than the filter pore size. Feces that reach the filter using a side opening 9b, which may be oriented rearward, are filtered with the help of negative pressure applied to the proximal end of the working channel 9f of the colonoscope 9e. It is destroyed until it is sufficiently diluted so that it can pass through the pores.

Further technical features In additional configurations, the previously disclosed rigid wire may have a lumen (as described in the context of an embodiment with a distal balloon attached). In this particular embodiment, the wire lumen inserts air into the distal spray head so that a mixture of air and irrigation fluid can be used to flush the colon or other body cavity. It may be used to do so.

In yet another embodiment of the device, the nozzle or opening is located at least along the distal 2 to 5 cm, or along the entire length of the tube. Due to the presence of such nozzles,
Device insertion and operability through the colon and working channel,
Self-propelled guidance through the colon or other body cavity,
It is possible to clean the internal working channel, i.e. to cause the destruction of fecal material that can be sucked into the working channel and block the suction channel.

  In yet another embodiment, the device may include an asymmetrical collapsible tube that, when inflated with water, can push fecal material that is still inside the working channel outwardly by dredging power. Such a working arrangement may be achieved by inflating the tube one point at a time (eg up to 1 cm) from the distal to the proximal part of the colonoscope.

  In yet another embodiment, the device is inflated / deflated so as to apply heel force to the inner wall of the colonoscopy working channel, thereby assisting in the destruction of fecal material remaining in the working channel. May be.

  In yet another embodiment of the present invention, the device may further include an additional, parallel, lumen extending along the length of the collapsible catheter sheath. This additional lumen has many purposes, including injection of therapeutic agents, injection of iodine (for chromoendoscopy), application of significant cold water to stop bleeding, and transfer of tumor-specific biomarkers May be used for. In addition, additional lumens may be used to introduce air for the delivery of an air mixture with the irrigation fluid. It should be noted that the additional lumen may have a very small diameter (eg, 0.2 to 1 mm) and may be housed within the collapsible tube.

  In an alternative embodiment, the distal spray head described above may be connected to a flexible tube that does not change its diameter (ie, unfolded) under liquid pressure. Such a configuration may be advantageous when it is mainly necessary to irrigate a specific location without necessarily allocating more space in the working channel. This configuration can also be used in situations where the space between the working channel and the irrigation water lumen is large enough to allow for the suction and / or insertion of additional tools through the working channel. May be advantageously employed. This particular embodiment has the following notable features while employing a conventional catheter tube.

By reducing the overall diameter of the distal spray head from 2 to 3 mm, it can be inserted through small lumens such as the working channel of a colonoscope,
The irrigation fluid is directed through a distal spray head cap mounted on the distal portion of the tube and a hole in the tube;
Wherever possible, special nozzles need to be designed to optimize pressure flow and avoid turbulence,
The inventive device described above is intended to allow maximum liquid driving force with a minimum liquid volume. For example, if the irrigation solution is converted to a spray with very small droplets, no cleaning effect is realized. Alternatively, if the nozzle is too large (eg, 0.8 mm to 3.8 mm) to provide the necessary cleaning propulsion for irrigation, a volume of irrigation fluid that is impractical is required,
The irrigation nozzle is centered forward (inward, outward, angled or straight), so that the physician can maximize the efficiency and the maximum effective force (liquid) in the direction of pointing the colonoscopy camera. Driving force),
A 360 degree automatic wash is available to allow irrigation where there is no field of view (eg, outside the field of view or for diverticulosis).

Distal Plug Guidewire Approach As previously described, the present invention provides sufficient cleaning of the colon or other body cavity located distal to the distal end of the endoscope without causing trauma and tissue damage. Means and techniques for supplying cleaning fluid to a spray head or nozzle located at the distal end of the endoscope working channel with sufficient pressure to allow for the generation of a jet spray The goal is to provide. The main technical problem that needs to be solved to achieve this goal is that the jet spray is formed enough without the need for a separate catheter to supply the irrigation fluid to the spray head. To build a high-pressure head. As explained above, the presence of such a catheter reduces the cross-section and volume of the working channel required for solid and liquid aspiration and increases the friction surface, so such fluid supply within the working channel. The use of a catheter is undesirable.

  The solutions provided by these embodiments of the present invention are further in their most common form a thin guidewire (eg having a diameter of about 0.3 to 0.8 mm), or (some implementations) A distal spray head or plug mounted in a very small diameter tube (in form) having a diameter of about 0.4 to 1.5 mm, for example. This spray head effectively functions as a perforated plug that can partially or completely occlude the distal outlet of the working channel. Thus, when partially occluding the distal outlet, irrigation fluid is supplied through the working channel and the fluid is placed in a body cavity (eg, colon) that is located just distal to the distal end of the working channel. Are ejected from the spray head at higher pressures in the form of jet scattering oriented towards the region of.

  Irrigation fluid may be supplied to the spray head as follows. That is, using a positive pressure water pump (peristalsis, centrifugal pump, dosing pump, gear pump, etc.) with a pump outlet pressure between 2 and 10 atmospheres to deliver irrigation fluid into the endoscope working channel, The pressure range at the discharge nozzle is 2 to 8 atm. The flow rate may be between 0.2 and 2 l / min. Connectors using sealing elements, adapters, and standard luer components may be used. It should be emphasized that the above pressure and flow parameters are for illustrative purposes only and do not limit the invention in any way.

  It should be noted that throughout the disclosure and description of the distal head guidewire solution, the terms “distal plug”, “distal head spray”, etc. are used interchangeably.

  A standard arrangement is shown in FIG. 31, which shows an endoscope 31f having a working channel 31g through which the cleaning device 31k of the present invention is introduced through an endoscope port 31e. The cleaning device 31k includes a guidewire / tube 31j having a distal head 31i attached to its distal end and a proximal handle 31a attached to the proximal end of the guidewire / tube 31j. Guidewire / tube 31j passes through tube 31t, which is attached to proximal handle 31a and can be sealably connected to endoscope port 31e. The tube 31t includes irrigation ports 31b and 31c for supplying irrigation fluid into the working channel 31g through the inside thereof, and a suction port 31d to which a vacuum pump may be connected. As will be described in detail below, the proximal handle 31a is advantageously designated by the letters (A, B, and C) of several working states of the endoscope / cleaner assembly (31f / 31k). ) Including a control mechanism.

  To achieve this function, the distal plug is configured to be moved between the following two structures.

  a) A first structure having a size that allows the spray head portion to pass distally through the working channel prior to irrigation and aspiration, and proximally after these procedures have been completed. This structure also provides a partial length tube or sleeve (with its distal end terminated a few centimeters from the distal end of the guidewire) to supply high pressure irrigation fluid to the distal portion of the endoscope working channel. Is also used to seal the distal outlet of the working channel to assist in cleaning the endoscope working channel. In this way, a positive hydrostatic force is applied to the vacuum pressure, thereby moving the particulate material proximally from the distal end of the working channel to prevent and / or eliminate blockages therein. The effect to do is improved remarkably. This first structure is typically employed when housed within an endoscope working channel (or other narrow instrument channel). The outer diameter of the distal plug is usually greater than the inner diameter of the working channel so that when the plug is received in the channel, its outer diameter decreases and the previously opened plug channel and opening closes. Is also configured to be slightly larger (a few millimeters).

  b) A second structure in which the spray head portion has an outer diameter larger than the first position. This occurs when the spray head (distal plug) leaves the working channel area (its distal end). A proximal force is then applied so that the distal plug contacts the distal outlet of the working channel, effectively providing a fluid seal over the outlet, and the working channel and its distal end are Only fluid movement to and from the region of the body cavity located beyond will be via the channels, openings and / or nozzles formed in the spray head.

  All of the above structures may be incorporated into one device.

  In use, while in its second expanded configuration, the spray head portion again allows free fluid movement between the working channel and the region of the body cavity located beyond its distal end. May move distally from their rest position above the working channel outlet (as described immediately above). In this state, the working channel may be employed as a suction channel for sucking fluid and solid debris from the body cavity in addition to the passage of the endoscopic instrument.

  The potential use of the working channel as an aspiration channel is that the very small diameter wire described above made of metal or plastic resin, rather than on a fluid supply catheter that occupies a correspondingly larger proportion of the available working channel volume. Or it should be emphasized that the spray head part is easily mounted on the tube. This wire or small diameter tube is sufficiently stiff that the operator can advance the distal plug within the working channel and transfer it into the body passage lumen. However, it also needs to be sufficiently flexible to go through the curvature and convolution in this body passage. The present invention also presents another problem with the latter device, ie, fluid delivery catheters with very small diameters need to use much higher pressure pumps than are currently used due to high resistance. Overcoming this problem.

  The presently disclosed device is also a second of the main objectives of the invention described above, namely an endoscopic instrument in such a way that blockage of this channel by fecal material is prevented or eliminated. Working channel irrigation and washing may also be used to accomplish this. Thus, whenever the working channel is occluded by feces (and / or other solid and semi-solid materials), or before it is occluded, the spray head portion of the present invention (see below in more detail). Mounted on a flexible wire, which in turn passes through a hollow tube through which irrigation fluid can pass. The tube may have a lateral opening formed along its entire length or part and / or an opening at the distal end. As an alternative to the above-described wires in the tube assembly, an additional, including a hollow wire or a thin tube with a lateral opening formed along its entire length or part and / or an opening at the distal end Embodiments may also be used. A cleaning fluid (water or special lysis solution) is pumped or injected into the proximal end of the hollow wire / tube so that the fluid is drained from the opening, thereby reducing the size of the solid debris. In the case of large obstructions caused by accumulation of solid material in the working channel, the distal spray head is repeatedly advanced (manually or automatically) and retracted, thereby mechanically contributing to the destruction of the obstruction To do. This combination of mechanical effect and fluid spray thereby allows for effective removal of solid material that might otherwise occlude the working channel.

  In addition to fluids that reduce the size of solid debris, the additional use of fluids, in addition to suction that is limited to pressures up to -1 atm, to help push stool and obstructions backwards, Generating a positive hydrostatic force (eg between 3 and 8 atm). In reality, the vacuum pressure actually realized at the distal part of the endoscope may be much less than -1 atm. In this configuration, it is necessary to seal the distal end of the endoscope.

  In another particularly preferred embodiment of the present invention, the above-defined objective of preventing or disrupting a blockage in the working channel during use of the presently disclosed device is that the guidewire has most of its length (but not This is accomplished using a version of the device that passes through a partial length tube or sheath over all (but not all). The proximal end of the partial length tube is secured within the proximal handle (as described in more detail below). The distal end of the partial length tube terminates a few centimeters (ie, proximal) of the distal end of the guidewire attached to the distal head spray section of the present invention. Any distal head spray section that will be described below may be used to realize this particularly preferred embodiment, but a spray head referred to as a “second spray head section embodiment” is particularly suitable. ing.

  Since the distal-proximal position of the distal end of the guidewire (as will be described later) changes during use, while the position of the partial length tube is fixed (relative to the proximal handle) The exact distance between the distal end of the partial length tube and the distal end of the more distally disposed guidewire will also vary, typically in the range of about 1 cm to about 4 cm. In general, the total length of the guidewire (usually built with a diameter of 0.5 to 0.6 mm) is approximately 150 cm to 210 cm, depending on the length of the endoscope used and the length of the external extension tubing. Within the range. The extension tubing is assembled between the endoscopic working channel adapter and the handheld device and typically has an inner diameter similar to the working channel diameter (typically 3.8 mm) and a length of 50 to 70 cm. The distal end of the guidewire is attached to the distal spray head by gluing, joining, or laser welding / soldering a metal guidewire and distal plug. Partial length tubes are typically made of PTFE tubing (for low friction) or ETFE, depending on the sterilization method used, with an outer diameter of about 1 mm to 1.6 mm and a wall of about 0.25 mm. Have pressure. However, it should be recognized that these measurements are provided as a general guide only and do not limit the scope of the invention in any way.

  In some embodiments of this version of the device, the device incorporates means for assisting the operator in recognizing and detecting the position of the distal spray head during use. In one such embodiment, half of the ratchet mechanism is attached to the distal surface of the endoscope leading to the distal outlet of the working channel. When the spray head is in contact with the distal outlet of the working channel, a clicking sound (generated by a ratchet mechanism) is made so that the distal head is close to the endoscope distal surface A complementary ratchet surface is incorporated into the proximal surface of the spray head portion to inform the operator. Other embodiments are for informing the position of the distal head, including a remote sensor or transmitter disposed on the distal surface of the endoscope in communication with a receiver or transmitter disposed on the proximal handle. It incorporates a different mechanism.

  This particularly preferred embodiment of the device of the present invention is shown in FIGS. 32A to 32C. Thus, FIG. 32A shows the distal spray portion 32a (mounted on the guide wire 32d) disposed within the distal outlet 32b of the colonoscope working channel 32c. Colon lumen irrigation is accomplished by passing irrigation fluid through the working channel 32c. The irrigation jet (32j) passes through a spray nozzle opening 32e disposed between the spray head portion 32a and the working channel outer periphery (32b).

  In FIG. 32B, the spray head 32a allows free aspiration (32s) of irrigation fluid and solid and semi-solid debris through a large space that exists between the guide wire (or tube) 32d and the working channel 32c. It is arranged outside the working channel 32c.

  FIG. 32C shows the inside of the partial length tube 32i to actively push liquid and fecal residue from distal to proximal direction through the lumen of the working channel 32c between the partial length tube 32i and the inner wall of the working channel. Shown is a nozzle sealing the endoscope working channel 32c to allow fluid pressure coming from the irrigation fluid to be diverted distally through the cavity.

  In order to move between three different modes of operation of a particularly preferred embodiment of the device (i.e. irrigation, aspiration, and working channel removal), a dedicated proximal handle is incorporated into the device so that the operator can apply irrigation fluid to the device. It is most convenient to be able to adjust the operating mode by manipulating a manual control that changes the position of the distal spray head as well as the passage through which it is transferred to the distal end of the I know that there is. Details of suitable devices are described below and shown in FIGS. 40A and 40B.

  The spray head portion of the present invention can change the size of the head portion by an operator, for example, by utilizing the linear motion of the head portion from the inside to the outside of the endoscope working channel, or vice versa. Thanks to having one or more structural or functional features, it can be moved between the various above-mentioned structures. However, the present invention is not limited to such mechanisms, but rather includes other mechanical or inflatable mechanisms that can be used to change the spray head structure, and the use of flexible resin silicone or rubber, Further embodiments are included.

  Several different embodiments of the distal spray head are described herein. However, it will be appreciated that there are many other structural variations that meet the functional requirements set forth above, and that these variations are equally considered within the scope of the present invention.

First Spray Head Part Embodiment In this embodiment, as shown in FIGS. 20-22, the distal spray head part 20 is generally conical (shown in FIGS. 21A and 21B) when at rest. Consists of a central portion 20c surrounded by a series of wings 20w or petal-like elements arranged to form a shape or frustoconical structure. However, when the device is inserted into the working channel, the petal-like element adopts a closed small diameter structure as shown in FIGS. 20A and 20B. To place the device in the second open configuration (as defined above), the head portion 20 is further advanced in the distal direction to leave the working channel through its distal outlet. As shown in FIGS. 22A and 22B, the petal-like element 20w is then further opened. This is due to the combination of the force applied between the drawers of the head and the resistance of the working channel outlet so as to employ a second frustoconical structure having the opposite orientation to that shown in FIGS. Achieved. The head portion 20 is then proximally (ie, facing back toward the operator) so that it eventually rests on the distal outlet of the working channel 32c, as shown in FIGS. 23A and 23B. ) Moved. In the structure, the narrow space between the side of the petal-like element 20w and the wall of the working channel distal outlet is similar to the narrow space between each of the elements as a “virtual nozzle” (20n in FIG. 23b). Form). Thus, when irrigation fluid is pumped through the working channel 32c, this fluid is used to wash the part of the colon or other body cavity that is located just distal to the distal outlet of the working channel 32c. Alternatively, the head portion 20 can be separated through these “virtual nozzles” 20n in the form of high-pressure spraying.

  As shown in FIGS. 22A and 22B, the distal head portion 20 further includes an internal passage 20g adapted to receive a distal portion of a guide wire or suitable tube therein through the proximal opening 20p. including. The internal passage 20g is further employed to add an irrigation stream via a nozzle 20z provided at the distal end of the distal head portion 20 by connecting a hollow guidewire or tube to the open proximal 20p. May be. There may be a fixedly attached stabilizing element 20q on the proximal portion of the central portion 20c that is adapted to facilitate movement of the distal head portion within the working channel.

  The “virtual nozzle” (20n) described above merely provides an example of a spray forming outlet that may be formed in this embodiment of the distal head portion 20, and others without departing from the scope of the present invention. It should be emphasized that other nozzle or opening shapes may be incorporated.

Second Spray Head Part Embodiment A further embodiment of the distal spray head part 24u of the present invention is shown in FIGS. 24A to 24D. As shown in FIG. 24A, this embodiment includes two concentrically arranged portions, the first of which is tubular in its proximal (lower) portion and its distal (upper) ) Part is an inner rigid (eg plastic or metal) part 24p with a frustoconical cap. As seen in FIG. 24C, the spray head portion 24u is mounted on a guide wire 24r that passes through both the tubular and cap lumens 24m of the inner rigid portion 24p. The second part is a flexible plug 24t that accommodates a central cavity (in which the upper part of the inner rigid part 24p is inserted) and is attached to its outer surface by an inclined skirt-like element 24k. The inner part 24p is mounted in the lumen of the outer part 24t so that it can be slid in the distal or proximal direction therein. The relationship between the inner and outer portions of this embodiment is shown in the longitudinal cross-sectional view provided in FIG. 24B. A side wing 24g sized so as not to interfere with the distal-proximal movement of the inner portion 24p within the lumen of the outer portion 24t is attached to the tubular portion of the inner rigid portion 24p of the device 24u. You can see from this figure. In the view provided in FIG. 24B, the side wings 24g are positioned along approximately half the length of the lumen of the flexible portion 24t outside the device 24u.

  FIG. 24C is a longitudinal cross-sectional view of the spray head portion 24u positioned within the lumen of the working channel 32c, near the distal outlet of the working channel. As the device 24u is manually advanced distally by the operator, the inner side wings 24g are relative to the outer flexible portion 24t so that they rest on the inner surface of the upper (distal) surface of the outer portion. Note that it is moved in the distal direction. It will also be seen from this figure that the inclined skirt-like element 24k of the outer flexible portion 24t of the device 24u is compressed by the inner wall of the colonoscope working channel 32c.

  As shown in FIG. 24D, the device 24u may be further advanced in the distal direction to leave the working channel 32c through its distal outlet 32x. When leaving the channel 32c, the pre-compressed inclined skirt-like element 24k causes the skirt-like element 24k to occlude the distal outlet of the working channel 32c at the same time as the device 24u is retracted slightly proximally. The device 24u can be returned to its expanded rest position to act as a mechanical stop, preventing the device 24u from returning proximally into the channel. In this first working position (also referred to herein as “irrigation mode”), irrigation fluid flows in the form of a high pressure spray through nozzles (24z, FIG. 24E) present on the top and sides of the rigid cap 24p. May be pumped through the working channel 32c. An example of a suitable nozzle 24z is shown in a transverse cross-sectional view of the upper region of the device 24u provided in FIG. 24E.

  If the operator wishes to perform irrigation fluid and / or debris aspiration through the working channel (hereinafter also referred to as “aspiration mode” and also shown in FIG. 33C), he or she simply The distal outlet of the spray head 24u is slightly advanced in the distal direction so that the distal outlet is unblocked, thereby “opening” the working channel to allow suction.

  Following the irrigation and suction procedure, the operator can manually withdraw the device through the working channel 32c, as shown in FIG. 24F. This step first requires the application of a temporarily applied force of a larger magnitude than previously used in the procedure to compress the skirt element 24k so that it can again enter the working channel 32c. And In this state, the compressed skirt 24k occludes the passage via the working channel 32c and fresh water supplied via the inner tube of the irrigation catheter of the present invention (32i in FIGS. 32 to 33). May be advantageously used to clean the working channel 32c with a stream (hereinafter "removal mode").

  An additional three-dimensional view of the above-described embodiment is shown in FIGS. 33A-33C, where FIGS. 33A and 33B are each sprayed in irrigation mode positioned over the outlet opening 32x of the working channel 32c. FIG. 33C shows a front and perspective view of the head 24u, with FIG. 33C showing the spray in suction mode being advanced further away from the exit opening 32x of the working channel 32c (eg, about 40 mm). The perspective view which shows the state of the head part 24u is shown.

  In another version of this embodiment of the spray head, the head includes an outer O-ring made of a flexible material such as silicone. The presence of this O-ring helps provide smooth movement between the various head positions when transitioning from one operating mode to another. The use of such an O-ring is particularly useful when the device of the present invention is used with an endoscope having an inner taper at the distal end of the working channel. In such a case, the passage of the distal head portion through the working channel has very little friction until the head portion enters the constricted distal portion of the working channel.

Third Spray Head Part Embodiment In another preferred embodiment of the present invention, shown schematically in FIGS. 27A-27D, the spray head part does not form a smooth uninterrupted arc on the outer surface of the balloon, Rather, it is provided in the form of a small balloon 27b having a predetermined shape so as to have a groove-like and wrinkled outer diameter. This head is then attached as a guide wire and on the distal portion of a small diameter tube or hollow wire 27t that serves to inflate the balloon 27b. This balloon 27b is guided through the working channel 32c in its contracted state (27b) to the distal portion of the endoscope until it reaches the distal outlet of the channel. At this point, the balloon is inflated (27bb) and partially occludes the flow, forming a virtual nozzle 27z between the recessed outer surface of the balloon 27bb and the working channel 32c. The fluid supplied through the working channel then leaves the channel in the form of a high pressure jet spray via the virtual nozzle 27z described above. After irrigation is complete, the balloon can be deflated to allocate space for aspiration. The shape of the balloon may be designed to incorporate various special design features such as different wall pressures, different inflated shapes, etc.

  The advantage of such an embodiment is that there is no need to push the nozzle forward to allocate the space for suction, so an optional pedal is provided instead of mechanically moving the device in and out of the endoscope That is, only the expansion pump may be used to simplify the user interface mechanism.

  The balloon 27b used in this embodiment is made of silicone rubber or latex, for example by molding and / or hot extrusion techniques and / or the use of Pebax, polyester, etc., as is well known in the prior art. Also good.

  Additional balloons may be assembled before or after the molded nozzle balloon to seal the exit of the endoscope to allow cleaning of the suction channel and / or assistance with suction. Thus, the irrigation solution can be pushed back by the high pressure water flowing into the distal portion of the endoscope through the inner tube. This embodiment (including an additional sealing balloon) is shown in FIGS. 34A-34E.

  In order to operate both balloons, multi-lumen / dual-lumen tubes may be used to operate all options alone. Thus, FIG. 34A shows an embodiment of an apparatus that includes both a spray head portion balloon 34b (nozzle balloon) and a sealing balloon 34s, both in a deflated state. An inflation tube 34t is also shown, the lumen of which is connected to the balloon lumen.

  In FIG. 34B, the nozzle balloon 34b is inflated to its working position, ie, the most distal portion of the working channel lumen 32c. Note that at this stage, the sealing balloon 34s is still in a deflated state. FIG. 34C shows the use of the device in this irrigation structure (indicated by dotted line 34j) of a body passage (irrigation mode) located distal to the distal end of the device.

  In FIG. 34D, both the nozzle balloon 34b and the sealing balloon are in a deflated state, thereby increasing the available space in the distal portion of the working channel 32c and the fluid and fecal debris ( Suction (in the suction mode) is enabled (indicated by arrow 34a). In FIG. 34E, the drawing shows the sealed balloon 34s in an inflated state (nozzle balloon 34b is deflated), and fluid and fecal debris through the working channel 32c by a high pressure jet in the proximal direction (removal mode). Fig. 4 illustrates how this configuration can be used to assist aspiration.

Fourth Spray Head Part Embodiment In this preferred embodiment of the invention shown in FIGS. 28A-28D, the spray head part 28u is provided in the form of a flexible mushroom valve (FIG. 28A), which is a working It is designed such that its overall diameter increases with increasing water pressure in the channel (FIG. 28B). Thus, when irrigation fluid is pumped into the working channel (indicated by arrow 28w in FIG. 28E), the mushroom head 28u expands until it causes a partial failure of the working channel's distal outlet, the only possible The basic flow is via a nozzle (28z shown in FIG. 28D) and / or a “virtual nozzle” (28v shown in FIG. 28C) formed in the spray head. The mushroom type valve used in this embodiment may be made of a flexible resin, such as, for example, polyurethane or flexible silicone rubber with a Shore-A hardness of 20 to 60.

Fifth Spray Head Part Embodiment In one preferred version of the device of the present invention, the distal spray head part (e.g. according to the first or fourth embodiment described above, and the improved suction described above is enabled. The one that also incorporates the mechanism) may be configured to incorporate biopsy forceps (or other surgical instrument) as shown as item 29f in FIGS. 29A-29E. This modified spray head allows for cleaning of the colon (or other body cavity) at a specific location just prior to performing a tissue biopsy. In one variation of this embodiment, the forceps opening mechanism allows creation of a spray nozzle. Such an arrangement is particularly advantageous in endoscopic surgical procedures that require replacing the endoscopic instrument with an irrigation nozzle and / or allocating room for aspiration. Furthermore, the inner tube (32i in FIG. 29D) may be assembled with the sealing mechanism described above to allow increased suction and working channel removal.

  The device described herein replaces the guide wire with the axis of the endoscopic surgical device and also assembles other subassemblies of the device (nozzle, inner tube, sealing) (FIG. 29D, items 28v and 32i), It may be incorporated in any endoscopic surgical apparatus (snare, forceps, biological forceps, injection needle, cutter, etc.). Item 28v shows the nozzle and optional sealing.

  In the various embodiments described above, the operator apparently controls the position of elements (such as various elements such as spray heads, biopsy scissors) disposed distally from the proximal end of the endoscope. There is a need. This may be accomplished in a variety of ways, using a variety of different elements including:

1. A simple handle for holding wires and tubes for distally pulling / pushing the distal head in and out of the working channel and for positioning the nozzle on the distal outlet.
2. A control thread for holding the device in a closed and / or released state.
3. A trigger to secure the distal portion at one or more locations.
4). Proximal part connected to plug-wire.
5. Torque mechanism.

  As previously explained, one of the advantages of the device of the present invention is that it allows for the aspiration of solid and dense materials through the working channel of the endoscope while reducing the possibility of occluding the channel. It is. An example of one type of suction system 35 is schematically illustrated in FIG. From this figure, this embodiment of the aspiration system 35 provides a passage that allows movement of aspirated liquid and fecal material from the patient's body cavity 35a through the endoscope working channel 35b to the waste container 35d. You will understand. Of particular note is that the system 35 does not require the use of special pump filters. Rather, the waste container 35d functions as a pressure buffer. In this way, the vacuum applied by the vacuum pump 35e can be created inside the waste container 35d and the connected tubing so that the operator performs suction by simply opening the valve 35c. Will be able to.

  The vacuum system 35 produces a rapid pressure change that allows the suction force to be repeatedly turned on and off, thereby allowing the solid debris agglomeration to be progressively advanced in the proximal direction.

  As already explained, certain embodiments of the guidewire device of the present invention (especially those comprising a partial length tube or sleeve that surrounds the guidewire over most of its length) are particulate and liquid materials from the working channel. Allows for enhanced removal of the material, thereby preventing occlusion. In this case, the method involves placing the distal head (32a in FIG. 32C) into the working channel (32c) so that the O-ring 32g is drawn into the working channel, thereby completely closing the outlet of the working channel. It involves a further step of drawing than already described (ie in connection with the irrigation phase). Once the outlet is occluded and the working channel is partially filled with feces and other debris, a high positive pressure pulse of liquid (or air) is directed distally through the lumen of the partial length sleeve (32i in FIG. 32C). This applies a positive pressure to the distal portion of the working channel, and as shown in FIG. 32C, thus a much higher force on the solid debris than would otherwise be possible. Add (ie by using a maximum of minus 1 atm generated by vacuum force).

  In addition to the vacuum force and side jets used to irrigate fecal debris within the working channel (as described above), additional mechanisms are employed to apply mechanical force to the solid debris. Also good. An example of such a mechanism is shown in FIGS. 25A-25C. This mechanism applies mechanical force to feces and debris and pushes debris backward. Such a mechanism is possible as long as the frictional force applied on the blade 25b has a correlation with the moment applied to the shaft 25s from the outside without reaching plastic deformation.

  Alternatively, as already explained, the wire moves around a few millimeters or centimeters to help avoid the occurrence of blockages or push the solid debris down (ie in the proximal direction) It is possible to use linear motion, which causes mechanical vibration and mechanical removal action.

  The linear motion described above can be more effective when any mechanical element is mounted on the wire (32d), such as a small deflector (30d), as illustrated in FIGS. 30A and 30B. . As shown in FIG. 30A, when a hollow wire or tube 32d is used, it is adjacent to deflector 30d to clean debris during removal mode by flowing a cleaning liquid through the hollow wire or tube 32d. The cleaning opening 30n may be further included.

  An additional embodiment of the device is provided at the distal portion of the wire to prevent large particles of feces and / or clots from entering the working channel that could otherwise occlude the channel. An attached washer-like filter may be included. In some embodiments, the nozzle head may also function as a built-in filter.

Sixth Spray Head Part Embodiment In one preferred version of the device of the present invention shown in FIGS. 37A-37C, the distal spray head part 37u is distal to the distal outlet of the working channel 32c. The direction of the jet spray leaving the nozzle is controlled by pushing or pulling part 37d, thereby deflecting the angle of the flexible wing 37w containing the spray channel 37c. This has the effect of diverging jet spray so that a wide-angle forward spray (37j in FIG. 37A), a narrow-angle forward spray (37k in FIG. 37B), and a side spray (37r in FIG. 37C) can be realized. Have. The latter spray direction can be effectively employed to clean an optical device placed on the distal tip of the endoscope. In order to achieve this directional effect, the distal head spray section 37u is configured to include a flexible wing 37w that deforms upon re-entry into the working channel 32c.

Seventh Nebulization Head Part Embodiment Sealing of the distal end of the endoscope working channel can be accomplished using a balloon mechanism (compliant and / or non-compliant material) that uses a pressure differential mechanism. This embodiment, shown schematically in FIGS. 38A-38C, is characterized by the presence of two rows of openings along the distal portion of the inner tube 38c. As shown in FIG. 38B, the opening 38h in the region where the balloon 38f is superimposed on the inner tube 38c is a second set of openings formed in the region of the distal tube where the balloon 38f is not superimposed. The diameter is larger than the portion 38g. This arrangement allows for the generation of hydrostatic pressure that results in a jet spray that first inflates the balloon 38f and then leaves the smaller opening 38g.

  This design is advantageous because it is a single operation (automatic) and no dual lumen or additional inflation tube is required (ie, the same conduit is inflated and back refluxed).

  This embodiment may also be used in vascular applications where aspiration can damage the arteries, or wherever an adjustment system for pressure balance in the lumen and in the balloon is required.

  The various elements of the example of this embodiment shown in FIGS. 38A-38C are as follows.

38a-working channel 38b-guide wire 38c-inner tube (shrink)
38d-Sealed balloon (shrink)
38e-Inner tube distal end occlusion 38f-Balloon (inflation)
38g—pressure opening 38h—inflation balloon opening 38i—forward hydrostatic pressure direction 38j—hydrostatic pressure advance

Operating Handle To control the distal spray head guidewire device and switch between various operating modes, the present invention further provides a proximal control handle that is switchable between the following three modes:

1. Irrigation mode—As described above, the nozzle (spray head) is located at the distal edge of the working channel forming a virtual nozzle spray. Irrigation fluid is flowed through a working channel in the space between the device and the channel. Control of the flow is achieved semi-automatically by pressing a button at a predetermined flow and pressure level, or by pressing a pedal switch.
2. Suction mode-the nozzle is located outside the working channel, preferably 5 to 20 mm distal to it. While the device is still in the body cavity being cleaned, vacuum pressure is applied and liquid and fecal residue are aspirated through the working channel.
3. Working channel removal mode—The distal head is positioned to completely seal the distal outlet of the endoscope working channel. In addition to vacuum pressure, distal fluid positive pressure is applied through the lumen of the partial length tube to assist in the suction process and prevent or remove blockage of the working channel by debris.

  Thus, from the above overview of three different modes of operation, it will be appreciated that the proximal handle has elements that can serve the following two main functions:

a) movement of the distal spray head between three different positions, and b) branching of the irrigation fluid to the desired path (ie working into the lumen of the partial length tube during working channel removal and directly working during irrigation) Into the channel).

  Although specifically intended for use with the irrigation / aspiration device of the present invention, the proximal control handle may be used for other purposes in endoscopic procedures, for example, ink or other markers into the colon lumen. It may also be used for the injection of substances.

  In a preferred embodiment, shown schematically in FIGS. 36A-36D, the control handle 31a may be configured to be used for switching between three different positions or modes. For example, handle component 31h has distal head portion 31i completely outside working channel 31g (ie, distal to the distal working channel outlet) in mode 2 (suction, shown in FIG. 36B), and mode 1 To switch the device between these various modes to be pulled back in (irrigation, shown in FIG. 36A) and further pulled back in mode 3 (strong suction or working channel removal, shown in FIG. 36C) , May be used.

  In an alternative embodiment shown in FIG. 36D, a handle 31y with a linear motion 31h between two mode positions and a trigger 31q for activating the third mode may be used. In such an embodiment, the handle 31y may move linearly between modes 1 and 2. Mode 3 is then activated by setting the handle to mode 2 and pressing the trigger 31q, which causes additional linear or rotational movement to seal the endoscope at the distal working channel exit. .

  A handle for the operator to control and switch between modes by differentiating the modes by a fixed linear position or by using different forces depending on the position at which the distal spray head is located May be recognized. Force feedback may be controlled by manual operator sensory feedback or using mechanisms that are sensitive to different forces and occlusions.

  40A-40B show a proximal control handle 40 that includes a proximal thumb ring 40r attached to a proximal housing 40d that includes a mechanism employed to change the cleaning apparatus of the present invention between different operating conditions. One particularly preferred embodiment is schematically shown. An outer tube 40t, whose proximal end is housed in the proximal housing 40d, extends distally therefrom. The guide wire 40w passes distally from the proximal housing and has a distal head portion 40h mounted at its distal end. Throughout its length, the guidewire 40w is coaxially connected by a partial length tube 40f terminating in a distal direction proximal to the head portion 40h, at a distance of 2 to 8 cm, preferably 4 cm therefrom. It is surrounded by. Proximal to the outer tube 40t disposed in the housing 40d is a slidable, for example having an hourglass shape, including two seals 40c each disposed on its wide base. There is a plunger 40g. The distal end of the slidable plunger 40g is used so that the slider element 40e can sealably slide the plunger 40g distally or proximally inside the proximal portion of the outer tube 40t. , Mechanically coupled at 40q to a slider element 40e disposed on the housing 40d.

  The proximal housing 40d further includes a spring 40s attached to the proximal wall of the housing 40d inside the outer tube 40t, a fluid inlet 40i, and two fluid passages 40a and 40b. The lumen of tube 40t is sealably divided into first and second compartments by a sealing septum 40p through which guidewire 40w of device 40 passes sealably, and the proximal compartment of the outer tube Includes a slidable plunger 40g, the distal section of which includes the proximal portion of a partial length tube 40f. The distal head portion 40h of the present invention is attached to the distal end of the guidewire 40w and the slidable plunger 40g is attached to the proximal end of the guidewire 40w. Ideally, the sealing septum 40p seals the guidewire only during the channel removal mode (does not seal during normal aspiration or irrigation, minimal guidewire friction is desirable, and sealing at 40p is Provided by a dynamic sealing mechanism (not required).

  The fluid passages 40a and 40b are provided with the inlet of the fluid passage 40b between the fluid inlet 40i and the proximal wall of the housing 40d, and the inlet of the fluid passage 40a is disposed on the distal side of the fluid inlet 40i. To communicate between the first and second compartments of the outer tube 40t. The outlet of the fluid passage 40a is provided in a part of the outer tube 40t disposed between the sealing partition wall 40p and the position where the proximal end of the inner tube 40f is sealably attached to the outer tube 40t. It is done.

  This arrangement of the proximal control handle 40 provides the necessary mechanism for moving the cleaning device of the present invention between different modes of operation. In the irrigation mode shown in FIG. 40A, the proximal seal 40c of the slidable plunger 40g is located between the fluid inlet 40i and the inlet of the fluid passage 40a, thereby allowing fluid to flow through the fluid passage. To prevent, the slider element 40e is disposed distally within the proximal portion. In this state, the distal spray head 40h is located at the distal end of the working channel, and the irrigation fluid stream introduced into the outer tube 40t via the fluid inlet 40i passes through the fluid passage 40b in the vicinity of the device. It flows in the lumen formed between the partial length tube 40f and the outer tube 40t in the center and in the space between the partial length tube 40f and the working channel wall at the distal portion of the device. Finally, at the most distal portion of the device, irrigation fluid passes through the opening of the distal head portion 40h in the form of a spray and is distal to the distal end of the colonoscope (or other endoscope). Passes into the colon (or other body passage) lumen placed in the

  If the operator wants to perform irrigation fluid and collapsed solid debris aspiration in the colon (or other body passage) lumen, the distal head 40h moves beyond the distal end of the endoscope Thus, the slider 40e is moved further in the distal direction so that the distal outlet of the working channel remains fully open. Direct the suction of fluid and removed debris into the working channel of the endoscope, pass through it proximally, exit the working channel of the endoscope from the check valve, and finally external Inlet pressure is applied to allow collection in the waste container.

  In the working channel removal mode shown in FIG. 40B, the slider element 40e is pulled proximally by the spring 40s, which is now compressed, until the movement of the slidable plunger 40g is progressively resisted, which is manipulated. The user is in the removal mode. In this mode, the proximal seal 40c is placed between the fluid inlet 40i and the inlet of the fluid passage 40b to prevent fluid from flowing therethrough. In this state, the distal spray head 40h is pulled proximally over the outlet of the working channel and enters the distal portion of the channel so that the outlet is completely occluded by the spray head. The stream of irrigation fluid is then introduced into the lumen of the partial length tube 40f via the fluid inlet 40i and fluid passage 40a and from there to the distal portion of the currently sealed working channel. The The irrigation fluid stream thus introduced then has a dual effect of proximal to distal flow through the lumen of the partial length tube and distal to proximal inspiratory pressure applied to the working channel. Passes in the opposite direction (ie, in the proximal direction) in the space between the partial length tube 40f and the wall of the working channel. In this way, the efficiency of the suction process is increased, thereby preventing the formation of a blockage in the working channel and / or disrupting any blockage that may have already been formed.

  The housing 40d is preferably made of ABS, polycarbonate, delrin, or other plastic resin, depending on the compatibility with the sterilization method (autoclave, gamma radiation, or ETO) used by mass production. Good. The length of the housing may typically be about 80 to 120 mm, and the diameter of the fluid passages 40a and 40b provided therein may typically be in the range of 2 mm to 4 mm. The outer tube 40t may be made of ETFE, PTFE, nylon, etc., preferably PTFE, depending on the length of the endoscope used and the length of the externally extending tubing, approximately 50 to 70 cm. In order to reduce the hysteresis effect, it preferably has a working channel diameter in the range of 2 mm to 4 mm smaller than the working channel diameter and an inner diameter (approximately AWG 8) and a wall thickness of about 0.5 to 1 mm. The partial length tube 40f may be made of ETFE, PTFE, or other plastic resin that has a low coefficient of friction and sufficient rigidity to support the device without folding and is compatible with applicable sterilization methods. . In an alternative flexible configuration, the partial length tube is made of silicone or rubber resin, preferably PTFE, for low friction between the guide wire and the tube and between the tube and the working channel. Depending on the length of the endoscope used and the length of the externally extending tubing, it has a length of about 150 cm to 210 cm, and an inner diameter usually in the range of 1 mm smaller to reduce the hysteresis effect (About AWG 16), and a wall thickness of about 0.25 mm to 0.4 mm. Guidewire 40w is preferably made of stainless steel 304V with an optional configuration of PTFE coating to reduce potential friction between the wire and the internal PTFE tube, and its diameter is usually , 0.5 to 0.7 mm, preferably about 0.6 mm.

  As described above, in the channel removal and suction mode, the irrigation fluid flows proximally through the working channel. In order to prevent this fluid stream from entering the fluid passage 40b, the fluid passage preferably allows only distal flow, so that the washing fluid flowing in the working channel during the removal mode is not It includes a check valve 40v that prevents it from flowing proximally therethrough. When pressurized fluid is introduced into the proximal portion of the outer tube during the removal mode, the slidable plunger 40g can quickly move distally, which causes the distal spray head 40h to move distally. It is important to include such a one-way flow restricting means (40v) in the fluid passage 40b in order to move it out of the working channel and thereby cause unintended changes in the mode of operation of the device. . Examples of suitable valve devices that may be used for this purpose include ball valves and platypus valves.

  It should be appreciated that the proximal handle described above is just one possible, non-limiting embodiment of a proximal portion that may be used in conjunction with the guidewire-mounted distal spray head portion of the present invention. .

  39 shows an irrigation pump 39p (for example, FLOJET diaphragm pump, peristaltic pump, or gear pump), vacuum pump 39v (for example, THOMAS diaphragm pump, piston pump), transformer 39m (for example, medical transformer Mean well / 200W medical FIG. 4 is a block diagram illustrating a preferred console implementation for the cleaning apparatus of the present invention, including a housing 39, which houses a series), safety timer 39t, irrigation pump relay 39y, and vacuum pump relay 39k.

  The housing 39 is connected by suitable piping to a water tank 39a used to supply cleaning fluid to the cleaning device 31k of the present invention 31 which is also in fluid communication with the console. In a preferred embodiment of the present invention, the irrigation pump 39p can provide a positive pressure between 2 and 10 atmospheres and a flow rate of about 1 liter / min. The flushing fluid that is flowed may be controlled by the operator using a pedal switch 39d that is electrically connected to the console. The console is also connected to the working channel of the colonoscope 31f in order to apply a vacuum inside by a vacuum pump 39v and suck debris, fecal matter and other particulate matter into the waste tank 39k. ing.

Additional Features of the Apparatus and Method of the Invention In a further embodiment of the invention, a fluid spray jet generated by the distal head nozzle is employed to facilitate insertion of the endoscope into the body passage. May be. Thus, the spray jet may assist by moving the folds of the gastrointestinal tract and stretching the folds, thereby facilitating the pushing and pulling of the endoscope. The spray jet is also sometimes used to remove large polyps, stones, or other obstacles that would be placed distal to the distal tip of the advancing endoscope from the gastrointestinal lumen Endoscope insertion may be supported. In addition to the movement of the obstacles, in some situations (ie in the case of certain stones) fluid spray jets will also be able to cause their collapse.

  Although various embodiments of the present invention have been described above as devices that are inserted into the working channel of a colonoscope or other endoscope, all of the above embodiments allow access to a body cavity. Note that it may be used equally well in any other lumen (eg, a dedicated catheter).

  In an alternative version of the device of the present invention, part or all of the length of the guide wire is provided in the form of a coil spring. This embodiment can damage the guidewire and attached distal head if the head accidentally slips to the side during ejection from the working channel during suction mode. This is advantageous in that it prevents the application of force.

  In other preferred embodiments of any of the above implementations of the device of the present invention, the distal head portion of the device is then placed in the colon rather than as a single, separate device that is then inserted into the working channel of the endoscope. It may be configured as an integrated part of an endoscope or other endoscope.

Claims (18)

An apparatus suitable for passing through an internal channel of an endoscope, comprising a distal plug having a proximal end and a distal end, through which the plug passes from the proximal end to the distal end Including channels, openings, and / or nozzles through which fluids can be passed to
The plug is connected to the distal end of the wire;
At least the outer portion of the distal plug can be elastically deformed such that its outer diameter is reduced in response to an applied inward radial compression force;
The channel, opening, and / or nozzle is closed when the distal plug is subjected to the compressive force and open when the plug is not under the compressive force. The equipment.   The device of claim 1, wherein the outer diameter of the distal plug when not subjected to an inward radial compressive force is slightly larger than the inner diameter of the endoscope working channel.   The device of claim 1, wherein the elastically deformable portion outside the distal plug is an O-ring. A tube that coaxially surrounds the wire;
The tube extends from the proximal end of the wire;
The apparatus of claim 1, wherein the length of the tube is less than the length of the wire such that a portion of the distal region of the wire remains unenclosed by the tube. Further including a proximal control handle;
The proximal end of the tube is connected to the handle;
The proximal end of the wire is movably connected to the handle;
The handle includes means for varying the distance between the handle and the distal end of the wire;
The handle includes one or more passages for connecting a fluid supply channel to one of the two or more fluid discharge channels;
The apparatus of claim 4, wherein the handle includes means for switching between a fluid discharge channel to which the fluid supply channel is connected.   The apparatus of claim 5, wherein the handle includes one drain channel in fluid communication with the lumen of the tube and a second fluid drain channel in fluid communication with a space surrounding the outer surface of the tube.   6. The apparatus of claim 5, wherein the means for changing the distance between the handle and the distal end of the wire comprises a slider. A body passage cleaning device suitable for passing through an endoscopic channel, comprising a distal head spray section with a channel, opening, and / or nozzle formed therein;
The distal head spray is connected to the distal end of the collapsible catheter and the distal end of the associated stiffening wire;
An apparatus wherein the collapsible catheter can minimize an expanded structure when a fluid stream passes through the interior, and can employ a folded structure when there is no fluid stream passing through the interior.   The apparatus of claim 8, wherein the collapsible catheter is a single lumen catheter.   The apparatus of claim 8, wherein the collapsible catheter has two or more lumens. A system for cleaning a body passage,
a) the device according to any one of claims 1 to 10;
b) a suction pump;
c) an irrigation pump;
d) A system comprising relays, transformers and computer equipment for controlling the functions of the device and pump. In a method for cleaning a body passage,
a) inserting an elongate medical device into the body passage so that its distal end is located near and proximal to the region of the passage to be cleaned;
b) a channel, opening formed therein through the internal channel of the elongate medical device such that the plug is positioned over the distal outlet of the internal channel and in contact with the distal surface of the medical device Passing the portion and / or the distal plug to which the nozzle is attached;
c) Introducing irrigation fluid into the internal channel at a pressure sufficient to cause the fluid to form a spray or jet upon passing through the channel, opening, and / or nozzle formed in the distal plug. Steps,
d) causing the spray or jet to wash a region of the body passage located just distal to the end of the channel;
e) moving the distal plug in a distal direction such that there is no contact between the plug and the distal surface of the elongate medical device in the body passageway;
f) applying a negative pressure to the proximal end of the internal channel of the elongated medical device to draw fluid and solid particulate matter through the internal channel;
g) if necessary, returning the distal plug to the position defined in step (b) and repeating steps (c) to (f).   13. The method of claim 12, wherein the elongate medical device is an endoscope and the internal channel is a working channel contained therein.   14. The method of claim 13, wherein the endoscope is a colonoscope and the body passage to be cleaned is part of the large intestine.   The method of claim 12, wherein the distal plug is attached to a guide wire.   A guide wire is surrounded by a partial length tube extending distally from the proximal end of the guide wire so that the length of the tube is such that a portion of the distal region of the wire is not surrounded by the tube. 16. The method of claim 15, wherein the method is less than the length of the wire to remain. i) retracting the distal plug into the distal end of the inner channel such that the plug is radially compressed, thereby reducing the outer diameter, thereby sealing the distal end of the inner channel;
ii) when fluid leaves the distal end of the tube, the positive fluid pressure supplied thereby assists in preventing or eliminating blockage in the distal portion of the internal channel of the elongated medical device. 17. The method of claim 16, further comprising introducing an irrigation fluid into the lumen of the long tube. In a method for cleaning a body passage,
a) inserting an elongate medical device into the body passage so that its distal end is located near and proximal to the region of the passage to be cleaned;
b) passing a device comprising a distal head spray section formed therein with a channel, opening, and / or nozzle attached into the internal channel of the elongate medical device, wherein The distal head spray is connected to the distal end of the collapsible catheter and the associated distal end of the stiffening wire so that the distal head spray is positioned beyond the distal outlet of the internal channel , Step and
c) within the lumen of the collapsible catheter with sufficient pressure to cause a fluid to form a spray or jet upon passing through channels, openings and / or nozzles formed in the distal spray head. Introducing an irrigation fluid into the
d) causing the spray or jet to wash the region of the body passage where the distal spray head is located;
e) closing the supply of irrigation fluid to the lumen of the collapsible catheter so that the wall of the catheter is folded, thereby reducing the volume of the internal channel occupied by the catheter; Optionally applying a negative pressure to the lateral opening;
f) applying negative pressure to the proximal end of the internal channel of the elongate medical device to draw fluid and solid particulate matter through the internal channel;
g) repeating steps (c) to (f) if necessary.

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