Systems and methods for cleaning body cavities

Abstract

Systems and methods for cleaning body cavities are presented. Some embodiments reduce size of fecal matter pieces within an evacuation conduit. Some comprise devices and methods for purging an evacuation conduit. Some comprise reduced cross-sectional profiles of a cleaning device. Some protect intestinal tissue by preventing exposure to excessively high and low pressures.

Claims

1. A colon cleaning device, comprising: an evacuation conduit configured for maneuverability from an anal sphincter at the proximal end of a colon through the curves of a colon to the distal end of said colon, and having a distal receiving aperture configured to receive suction for drawing fecal material from at least a portion of said colon and into a lumen of the evacuation conduit while inserted to said colon; and a fluid supply channel, having a supply aperture positioned where a pressure differential between the supply aperture and the evacuation conduit lumen induced by the suction changes upon blockage of said receiving aperture; and wherein the supply aperture position is furthermore external to the evacuation conduit lumen, and near a bypass orifice which is separate from the receiving aperture and providing passage of fecal material from at least one other portion of said colon into the evacuation conduit lumen, into which bypass orifice the change in pressure differential elicits the drawing of fluid exiting said supply aperture, such that a pressure differential across said receiving aperture is reduced.

2. The colon cleaning device of claim 1, wherein said fluid supply channel comprises an irrigation channel, operable by proximally applied pressure to supply fluid exiting said fluid supply channel in a region external to said receiving aperture.

3. The colon cleaning device of claim 1, whereinwhen said blockage occurssaid pressure differential is reduced to below a level at which damage to an intestinal wall occurs.

4. The colon cleaning device according to claim 1, wherein said supply aperture is in a luminal wall of said evacuation conduit.

5. The colon cleaning device of claim 1, comprising: a pressure sensor, positioned within said evacuation conduit and near a distal end thereof; a pressurizing fluid supply for forcing fluid through said fluid supply channel; and a controller, configured to control delivery of said fluid supply as a function of a measured pressure reported by said sensor.

6. The colon cleaning device of claim 2, wherein said supplied fluid comprises a fluid jet configured to reduce fecal matter size outside said evacuation conduit, wherein said jet is drawn through said evacuation conduit upon said receiving of said suction and upon said blockage of said receiving aperture, such that said pressure differential across said receiving aperture is reduced.

7. The colon cleaning device of claim 1, where said pressure differential is further reduced by closing of a closure mechanism inside said evacuation conduit.

8. The colon cleaning device of claim 2, wherein said closing is activated by the pressure of fluid issuing from said fluid supply channel.

9. A method of preventing damage to an intestinal wall during cleaning, comprising: applying suction to an evacuation conduit of a colon cleaning device inserted into an intestine via the anal sphincter, the evacuation conduit being of sufficiently reduced cross-section for maneuverability from an anal sphincter at the proximal end of a colon through the curves of a colon to the distal end of said colon; sucking a portion of the wall of said intestine against a fecal matter receiving aperture of said evacuation conduit; supplying liquid within said evacuation conduit, the supplied liquid issuing from a distal supply aperture of a fluid supply channel, wherein the distal supply aperture is external to the evacuation conduit, and wherein the fluid supply channel has a proximal connection to a fluid supply source outside said anal sphincter; the fluid then passing into the evacuation conduit through a bypass aperture separate from the receiving aperture and positioned near an end of the evacuation conduit positioned at the distal end of the colon, to reduce the pressure differential acting on said portion of intestinal wall induced by said suction.

10. The method of claim 9, wherein said supplying of fluid comprises diverting irrigation fluid supplied to a supply aperture outside said evacuation conduit to the inside thereof through a vacuum reduction opening separate from said receiving aperture.

11. The method of claim 9, wherein said supplying of fluid comprises drawing fluid from said supply aperture inside said evacuation conduit, said drawing being in response to said pressure differential.

12. The method of claim 9, wherein said supplying of fluid comprises: sensing of a pressure change by a sensor located in said evacuation conduit; and activation by a controller of a pressure source configured to supply said fluid; wherein said activation is determined based on said pressure change sensed by said sensor.

13. The colon cleaning device of claim 1, wherein the length of said evacuation conduit insertable into the colon is between 1 and 2.5 meters.

14. The colon cleaning device of claim 1, wherein the outer diameter of said evacuation conduit fits within a system diameter of between 1 and 2.5 cm.

15. The colon cleaning device of claim 1, wherein being configured for maneuverability through the curves of the colon comprises having a sufficiently reduced cross-section.

16. The colon cleaning device of claim 1, wherein the fluid exiting said fluid supply channel comprises liquid.

17. The colon cleaning device of claim 1, wherein said fluid supply channel comprises an irrigation channel, operable by proximally applied pressure to supply fluid exiting said fluid supply channel into lumen of said colon at a region external to said bypass orifice between an opening of said irrigation channel and said bypass orifice.

18. The colon cleaning device of claim 17, wherein at least a portion of said fluid supplied into said lumen of said colon is drawn into said bypass orifice by said change in pressure differential.

19. The colon cleaning device of claim 1, wherein at least a portion of said fluid supply is drawn from said intestinal lumen into said bypass orifice.

20. The colon cleaning device of claim 12, wherein said pressure change sensed by said sensor comprises low pressure in said evacuation conduit.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

(2) FIG. 1 presents a cleaning device which comprises a high-pressure fluid input for shredding matter within an exhaust lumen of the device, according to some embodiments of the present invention;

(3) FIGS. 2A-2F present cleaning devices which comprise mechanism for purging an exhaust passageway, according to some embodiments of the present invention;

(4) FIGS. 3A-3C present cleaning devices using multiple fluid input pipes and/or flattened exhaust lumens to reduce device cross-sectional area of the devices, according to some embodiments of the present invention;

(5) FIGS. 4A-4F present cleaning devices each having a multi-lobe exhaust lumen which comprises a plurality of co-aligned (substantially parallel) lobes running the length of the lumen, according to some embodiments of the present invention;

(6) FIGS. 5A-5F show processes for conveying matter out of an exhaust conduit of a cleaning device, and for breaking conveyed matter into small pieces for easier transport, according to some embodiments of the present invention;

(7) FIGS. 6A and 6B present a cleaning device which provide water jets for irrigating an intestine, according to some embodiments of the present invention;

(8) FIG. 6C presents a cleaning device with a material transportation mechanism which comprises an active distal head and a medial power train, according to some embodiments of the present invention;

(9) FIGS. 7A-7D present cleaning devices using pressure sensors to provide safety features, according to some embodiments of the present invention;

(10) FIGS. 8A and 8B illustrate use of a fluid bypass to prevent dangerous pressure vacuum in an exhaust lumen of a cleaning device, according to some embodiments of the present invention. FIG. 8B presents a bypass orifice according to an embodiment of the present invention; FIG. 8A presents a similar configuration without the bypass;

(11) FIGS. 9A-9C present water jets being used to keep open a bypass orifice, according to some embodiments of the present invention;

(12) FIGS. 10A-10D present a helical matter transportation mechanism which comprises a hollow central portion, according to some embodiments of the present invention; FIGS. 10B-10D also comprise an internal bypass; and

(13) FIG. 11 presents an additional bypass configuration, according to some embodiments of the present invention.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

(14) The present invention, in some embodiments thereof, relates to a system for cleaning body conduits and/or body cavities, and more particularly, but not exclusively, to a system for cleaning the lower GI tract.

(15) It is to be noted that features from the various embodiments presented and discussed herein can be mixed and combined. The figures and discussion of the figures have been selected to simplify presentation and understanding in isolation of features which are intended to be used together. Note also that where specific utilizations of presented features are mentioned, these utilizations are exemplary only and should not be considered limiting; the described embodiments illustrate features which may be used to answer a variety of needs and purposes including, but not limited to, purposes mentioned in this disclosure.

(16) Embodiments are presented below in the following general order: Embodiments illustrating features that can be suitable for purging an evacuation conduit of a cleaning device (FIGS. 2A-2F) Embodiments illustrating features that can be suitable for graining of fecal matter within an evacuation conduit of a cleaning device by one or more of: Cutting and shredding fecal matter using high-velocity liquid sprays, (FIG. 1) Grinding within an evacuation conduit (FIGS. 5A-6B) Creating turbulence within an evacuation conduit (FIGS. 4A-4F) Pulling matter pieces apart by subjecting them to contradictory pulling forces (FIGS. 4A-4F) Embodiments illustrating features that can be suitable for providing mechanical power to graining tools within an evacuation conduit (FIG. 6B) Embodiments illustrating features that can be suitable for reducing the cross-sectional profile of a cleaning device (FIGS. 3A-3C), and Embodiments illustrating features that can be suitable for protecting intestinal tissue by one or more of Preventing exposure of tissue to excessive pressure due to over-inflation of an intestine when liquid is supplied for cleaning purposes, and Preventing exposure of tissue to dangerously low pressure when suction is created in an evacuation conduit.

(17) Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth in the following description and/or illustrated in the drawings and/or the Examples.

(18) The invention is capable of other embodiments or of being practiced or carried out in various ways.

(19) Cleaning Device which Comprises a Purging System

(20) Attention is now drawn to FIGS. 2A-2F which illustrate an endoscope or other cleaning device 300 with a self purging system, according to some embodiments of the present invention.

(21) FIGS. 2A-2F present a cleaning device 300 insertable in a colon 133 and which comprises an evacuation conduit 128 (also called an exhaust lumen 128 herein) for transporting material from said colon out of a body. Conduit 128 comprises a closure mechanism 144 positioned near a distal end 134 of conduit 128. Closure mechanism 144 may be a rotatable flap 146 rotating on a hinge 147, or may be a one-way valve operated hydraulically, or may be any other closure mechanism.

(22) When closure mechanism 144 is open, matter from intestine 133 can flow into conduit 128 and be moved out of the body. When closure mechanism 144 is closed, it at least partially (and in some embodiments entirely) prevents fluid from conduit 128 from flowing through distal end 134 and into intestine 133. When closure mechanism 144 is closed, it partially or substantially or completely prevents fluid movement within conduit 128 from influencing tissues of intestine 133.

(23) Cleaner 300 may comprise a high-pressure fluid source 1441 and/or a high-volume fluid source 1442 and/or a vacuum source 1443, optionally commanded by values which are optionally controlled by a controller 200, as shown in FIG. 2C.

(24) Fluid sources 1441 and 1442, if present, connect to a fluid input channel 149 having distal orifices 149A and 149B. These orifices conduct fluid in channel 149 to enter conduit 128 at a position proximal to closure mechanism 144 and optionally near to mechanism 144.

(25) Cleaner 300 may also comprise a vacuum source 1443, also optionally controlled by a valve commanded by controller 200.

(26) According to some methods of using cleaner 300, cleaner 300 can be used to introduce a cleaning liquid such as water into intestine 133 through an irrigation channel (not shown), and conduit 128 can be used to conduct materials from intestine 133, through distal end 134 of conduit 128, and proximally through conduit 128 and out of the body. Conduit 128 may comprise a material transportation mechanism 137 (not shown in these figures but shown elsewhere herein) for moving such materials through conduit 128 and out of the body.

(27) According to some methods of using cleaner 300, occasionally, (e.g., either periodically and regularly or when flow impediments are detected by a user or by controller 200), closure mechanism 144 is closed, isolating the interior of conduit 128 from intestine 133, and then a pressure differential is created between a medial portion of conduit 128 and a proximal end of conduit 128. This pressure differential, whether of liquid or gas or a mixture of both, purges conduit 128 by pushing its contents toward its proximal end. FIG. 2A shows mechanism 144 open, FIG. 2B shows mechanism 144 closed, and FIG. 2C shows fluid (gas or liquid) optionally being supplied from source 1441 and/or source 1442, and vacuum optionally being applied from source 1443, and creating a pressure differential which causes materials in conduit 128 to flow toward its proximal end and out of the body.

(28) Closure mechanism 144 maybe be closed and opened mechanically (e.g. by a connecting rod, not shown), electromagnetically, or in any other manner. Its closure is optionally commanded by controller 200.

(29) FIGS. 2D, 2E, and 2F show an alternative implementation of closure mechanism 144 which is a one-way valve 154 optionally closed and by hydraulic pressure and optionally opened by hydraulic pressure or by a weak spring (not shown). FIG. 2D shows valve 154 in its open position, where it optionally serves also to close orifices 149A, 149B. FIG. 2E shows flow of fluid through orifices 149A, 149B, where hydraulic pressure moves valve 154 toward its closed position. FIG. 2F shows valve 154 in its closed position against a stop 156, where it isolates intestine 133 from influence by fluid flows within medial and proximal portions of conduit 128.

(30) Cleaning Device Using High-Pressure Fluid Jets to Shred Matter in an Evacuation Conduit:

(31) Attention is now drawn to FIG. 1, which presents a cleaning device which uses high-pressure water for cutting or otherwise graining fecal materials contained in an evacuation conduit 128, according to some embodiments of the present invention.

(32) Known systems for cleaning a colon use water to irrigate the colon and to wash the colon and/or to dilute or dislodge fecal matter within the colon, and also to wash fecal matter from the colon out of the body through an evacuation lumen.

(33) These devices do not use high pressure fluids to shred nor to move fecal matter. Indeed, water jet power is limited by the FDA, which requires that pressure of water introduced into the colon be sufficiently low to prevent damage to tissues which might be caused by pressure from a water jet. In consequence, feces tends to be liberated from the intestinal walls and from impacted feces portions in chunks which will not easily pass through an evacuation conduit, both because of the size of the chunks and because only low water pressure is provided in the intestine itself.

(34) In an exemplary embodiment of the invention, high pressure jets are used to dismember feces, however, they are contained so they cannot contact and damage tissue. In an exemplary embodiment of the invention, the jets have a velocity of between 0.1 m/s and 10 m/s or more, such as 15 m/s or 20 m/s, or, for example, 1 m/s, 5 m/s, 7 m/s or intervening velocities. Optionally, the velocity and cross-section of the jet is such that the jet would cause damage and/or penetration of GI tissue if impinging on the tissue from a distance of 3 cm or less, optionally even with intervening water. Optionally or alternatively, the pressure used is such that the jet would penetrate and/or damage tissue if the nozzle was in contact with tissue. For example, the pressure may be above 4 bar, above 10 bar, above 20 bar or intermediate pressures. Optionally, the jets include particulate matter, which would damage tissue if hurled at tissue with force, but assist in breaking down feces.

(35) FIG. 1 presents an intestinal cleaning device 130 insertable in an intestine 133 and comprising an evacuation conduit 128. Device 130 uses a high-pressure fluid source 1301 connected to lateral openings 138A, 138B into conduit 128 to produce high-speed high-pressure water jets 139 within the protected environment inside conduit 128, to cut or otherwise grain the fecal material contained in conduit 128.

(36) According to some embodiments of the present invention a method for cleaning a colon by drawing fecal matter from a colon in an evacuation conduit method comprises inserting device 130 in a colon, irrigating the colon to liberate fecal material, using suction to draw liberated fecal material into conduit 128, and connecting a source 1301 of high-pressure fluid to lateral opening 138A and 138B to produce a high-velocity fluid jet directed toward the interior of conduit 128, where jets 139 will interact with the liberated fecal matter, reducing in size pieces of the liberated fecal matter and thereby facilitating drawing said fecal matter from said colon through said conduit.

(37) Device 130 comprises a fluid input conduit 136 proximally connected to a fluid source, optionally high-pressure 1301 and distally connected to lateral openings 138A, 138B in a wall 131 of exhaust conduit 128 of device 130. When high pressure fluid (e.g. water) is allowed by a valve 1302 (optionally remotely controlled by a controller 1303) to pass into fluid input conduit 136, passage of the high-pressure fluid through opening 138A and optional additional openings 138B creates high-speed high-pressure fluid jets 139 aimed at contents of exhaust conduit 128. In some embodiments jets 139 are aimed away from all distal openings 132 of exhaust conduit 128, thereby protecting body tissues outside openings 132 from exposure to direct contact with jets 139.

(38) Exhaust conduit 128 may optionally comprise a matter transportation mechanism 137 for transporting matter out of the body through conduit 128. In an exemplary embodiment shown in FIG. 1, mechanism 137 is embodied as a helical spring 1371.

(39) Device 130 also has an optional second fluid input pipe 135 for introducing a fluid 1351 (typically water) into intestine 133 at a pressure low enough to avoid damage to the GI wall.

(40) Openings 138A, 138B are so positioned and so constructed that jets 139 are so directed that should lumen 128 be free of intervening material objects such as feces, jets 139 are directed towards walls 131 or towards internal components of device 130 (such as transporting mechanism 137) within lumen 128, and are not directed towards distal opening 132.

(41) In an exemplary embodiment of the invention, a method using device 130 comprises directing high pressure jets of water or other fluid toward fecal matter or other objects within lumen 128. Low-volume high-pressure fluid flows are used, as these have an effective cutting or shredding effect on such materials. Body tissues outside device 130 are not subject to high pressures because jets 139 are directed towards internal parts of device 130 and not towards distal opening 132, and those body tissues are not subject to massive and/or penetrating fluid flow as a result of this process because high-pressure low-volume flows are used.

(42) High velocity jets 139 produced in device 130 can act as cutters and shredders, and can have the effect of breaking large chunks of feces into smaller chunks more easily transported and less likely to clog exhaust lumen 128. Intestinal tissues are protected from the force of the fluid jet because the process takes place within the device 130 and not in the open GI lumen, and if no feces are present to take the brunt of the high-pressure fluid flow, the jets 139 will hit the hard wall 131 of lumen 128 and bounce back or be otherwise diffused, and consequently will not damage intestinal tissue.

(43) In an exemplary embodiment of the invention, a shredding section of the device is between 2 and 20 cm long, for example, between 3 and 7 cm long. Optionally, over such a section, if, for example, an axial rotating shredding coil (e.g., FIGS. 5A-5C) is used for shredding, the spacing between coils goes down by between 20% and 90%, for example, 50%, or more. Optionally or alternatively, over such a section the diameter of the coils can increase by a factor of, for example, between 2 and 6. In an exemplary embodiment of the invention, the initial diameter and spacing between coils is 3 mm and 10 mm respectively. In some embodiments, the initial spacing between coils is small and then grows and then optionally decreases. In an exemplary embodiment of the invention, the speed of rotation of the coil is between 1 and 7000 rotations per minute, for example, between 3000 and 5000, or more, optionally controllable by an external circuit and user input and/or be set by a manual rotation speed.

(44) In an exemplary embodiment of the invention, between 2 and 10 jets are provided, optionally with spacing of between 2 mm and 30 mm between adjacent jets. Optionally, the jets are at different axial positions along the lumen. Optionally or alternatively, the jets are at different circumferential positions.

(45) Conveying and/or Shredding Matter within an Exhaust Conduit

(46) Attention is now drawn to FIGS. 5A-5C, which show processes for conveying matter out of an exhaust conduit of a cleaning device, and for graining that matter (i.e. breaking conveyed matter into small pieces for easier transport).

(47) FIG. 5A presents a cleaning device 11A in which an inner spring 21A whose windings are wound tightly one against another is positioned within an outer spring 20A whose windings are also positioned tightly on against another, as shown in the figure. Both inner spring 21A and outer spring 20A have what is sometimes called a zero gap or step between spring helix windings, meaning that no space is left between successive windings, as shown. In use, inner spring 21A is rotated, producing the effect of moving pieces of fecal matter 22 proximally and eventually causing them to exit the body. Rotation of inner spring 21A grains and moves fecal parts 22 from the body's cavity and outside it. As shown in the figure, inner spring 21A and outer spring 20A are typically fabricated to be wound in opposite directions, one clockwise and the other counter clockwise. Physical interactions of matter pieces 22 with moving inner spring 21A and static outer spring 20A both transport material pieces 22 proximally but also tend to break pieces 22 into smaller pieces through frictional interactions between pieces 22 and the inner and outer springs. However, the system of FIG. 5A produces only a low speed in transporting matter proximally out of device 11A, and room is available to handle only small pieces of fecal matter 22 because only small pieces will fit between the inner and outer springs

(48) Using outer spring 20A with a zero gap is safe so long as device 11A is positioned in a straight line, but may become unsafe if device 11A is forced into a curved path, as is typically the case in processes of cleaning an intestine. One danger is that portions of intestinal wall can become injured when curving of outer spring 20A creates a gap between spring windings, into which space a portion of intestinal wall can become caught and be injured. This problem is discussed in detail in U.S. Pat. No. 4,923,460.

(49) FIG. 5B illustrates a cleaning device 11B with an inner spring (21B) with wide gaps or steps between each winding of the spring helix. In this embodiment outer spring 20A has a zero-gap winding as shown in FIG. 5A. Rotating wide-gap inner spring 21A can be effective in transporting material in a proximal direction because the wide steps of inner spring 21A advance material rapidly when spring 21A is rotated, and device 11B can handle large fecal pieces 22 since wide-spaced inner spring 21A allows room for them, but there is little graining effect (breaking large fecal pieces into small pieces) because the wide gaps of the inner spring don't tend to force fecal pieces 22 against outer spring 20A.

(50) FIG. 5C presents a cleaning device 11C wherein an inner spring 21B with wide gaps or steps between spring helix windings interacts with an outer spring 20B also having a wide gap. This design has the disadvantage that it conveys matter poorly because of the gap between the outer spring helix windings: if fluid or small fecal parts are moved proximally by inner spring 21B and encounter resistance due to colon geometry or other factors, then fecal parts and fluids will tend to escape from between windings of outer spring 20B as shown at label 22A of FIG. 5C, and may even move backwards and reenter outer spring 20B at a more distal position, as shown at label 22B. In other words, device 11C may not function efficiently as a machine for graining and conveying fecal matter. Moreover, an outer spring 20B with wide gaps between windings may be unsafe since the colon wall could easily catch inside such windings and be damaged and even perforated.

(51) FIGS. 5D-5F present devices for transporting and graining fecal matter according to embodiments of the present invention. FIG. 5D presents a device 11D which is similar to device 11C shown in FIG. 5C, but differs therefrom in that the described apparatus is contained within a flexible outer pipe or tube 23, which is absent in FIGS. 5A-5C. Tube 23 prevents the unwanted effects described above with reference to FIGS. 5A-5C. Fecal matter and fluids move proximally in a highly efficient manner, the hazard of a colon wall touching or being caught in the inner or outer springs is eliminated, and the system can provide both high graining power and fast conveying speed.

(52) In some embodiments tube 23 has a smooth exterior surface and a non-smooth or abrasive interior surface which defines an exhaust lumen. The non-smooth interior of wall 23 can be formed as a helical form glued or welded an inner side of wall 23, the helical form being wound either in the same direction as a helical inner spring 21B, or in an opposite direction. In some embodiments these windings are at least 0.5 mm apart. An inner spring 21B of this embodiment can be formed as described above for devices 11B and 11C. In some embodiments windings of inner spring 21B are also at least 0.5 mm apart.

(53) Alternatively, inner spring 21B may be embodied as any other form of object positionable within pipe 23 and operable to rotate and to advance and retract freely within pipe 23, such as a helical brush or other form of brush, a paddle, a propeller, or any other rotatable object.

(54) FIG. 5E shows a graining effect as that might be created by device 11A of FIG. 5A. A small fecal part 22 between the outer spring 20A and inner spring 21A encounters only a minor graining effect because the ridges encountered by part 22 are small. In contrast, FIG. 5F shows large ridges presented by windings of spring 21B, which large ridges produce a strong graining effect, while spaced-apart windings of spring 21B in this embodiment enable large feces pieces 22 to be handled.

(55) FIGS. 6A and 6B present a cleaning devices 12A, 12B which comprise water jet production units in which fluid inserted via a pipe 24 from a water source passes through lumens of a housing 25 and emerge from a nozzle 26 into an intestine. Water jets emerging from nozzles 26 can be used to break down fecal matter into small parts which can then be transported distally out of the body. Water jet production units may be comprised in any of the embodiments presented herein.

(56) Exemplary Embodiments for Graining and/or Exhausting Fecal Matter:

(57) Attention is now drawn to FIGS. 4A-4F, which present embodiments which include features that facilitate graining of fecal matter within an evacuation conduit of a cleaning device by creating turbulence within the conduit and by grinding and cutting the pieces and by pulling them apart by subjecting them to contradictory pulling forces.

(58) FIGS. 4A-4F present cleaning devices each having a multi-lobe exhaust lumen which comprises a plurality of co-aligned lobes running side by side along at least a portion of the length of the lumen, according to embodiments of the present invention.

(59) FIG. 4A shows a device 10D comprising within a housing 5 an (optional) endoscope optic 4, one or more fluid input conduits 2, and a matter exhaust lumen 1D shaped within housing 5 and which comprises a first lobe 101 and a second lobe 102. Lobes 101 and 102 are in fluid communication along at least a part of their length, which is to say that fluid and other matter can flow between them. Each lobe has a central axis (shown as a + in the figure) and optionally has a cross-section at least part of which has a circular border, as shown in FIG. 4A. Lumen 1D as a whole has a roughly figure 8 shape, optionally providing room for a fluid input lumen 2A as shown in FIG. 4A.

(60) FIG. 4B shows a cleaning device 10E wherein a two-lobed exhaust lumen 1E contains a rotatable device in one or in both lobes. FIG. 4B shows a rotatable device 6A in lobe 101 and a rotatable device 6B in lobe 102. It is to be understood however that device 10E may comprise one rotatable device or two.

(61) Lobes 101 and 102 are open to each other, in the sense that fluid communication between them is possible along at least a portion of their length.

(62) Lobes 101 and 102 are sized and shaped with respect to helical devices 6A and 6B in such a way that devices 6A and 6B are independently rotatable each within its lobe, and are also optionally able to independently advance and retract each within its lobe. However, a shoulder 1G, or other similar formation, prevents devices 6A and 6B from moving from moving sideways from one lobe into another.

(63) In some embodiments devices 6A and 6B can be rotated in the directions shown by the small arrows in FIG. 4B: clockwise in lobe 101 and counterclockwise in lobe 102. In some embodiments both can be rotated in directions opposite to those shown in the figure, i.e. counterclockwise in lobe 101 and clockwise in lobe 102. These directions cause portions of devices 6A and 6B which approach each other within their common lumen 1E to approach a parallel movement where they are closest together, and then to pull apart.

(64) Alternatively, in some embodiments devices 6A and 6B can be rotated in opposing directions (i.e. clockwise in both lobes or counterclockwise in both lobes), which causes the two devices 6A and 6B to be moving in opposing directions where they are at their closest approach. Additionally, in some embodiments one or both rotatable devices can be caused to alternate rotational direction.

(65) In some embodiments, devices 6A and 6B are helical devices (also designated 6A and 6B. If device 1E is inserted in an intestine, rotation of a helical device in one direction serves to pull matter towards the intestine, while rotation in the opposite direction serves to pull matter away from the intestine. Rotating one helical device in a direction which pulls matter towards the intestine and rotating the other in a direction which pulls matter away from the intestine will create shearing forces which will contribute to graining of matter caught between the helices.

(66) In general, that diversity of movements described above (pulling towards intestine or away, rotating the create parallel movement or opposite movement, and independently moving helices or other rotating devices forward and backward in their lumen) create pulling, pushing and cutting forces which can serve to cut, grind, and otherwise grain material within lumen 1E.

(67) In some embodiments, additional graining effects can be produced when helical devices 6A and 6B are caused to overlap, as is shown in FIG. 4C. Overlapping helical devices can provide efficient pumping action and can also contribute to shredding the content of lumen 1E.

(68) Helical devices 6A and 6B can be helical springs, can be rods or pipes surrounded by a helical thread can be formed as a helical brush similar to those used to clean colonoscope working channels, or can be a wire or a rope wire made from stainless steel or another material.

(69) Components having forms other than helical can also be used in one or both of lobes 101 and 102. An example is given in FIG. 4D, where two paddle-shaped forms 106A and 106B are provided in place of helical devices 6A and 6B. (Rotating paddles create turbulence which generates shearing and tearing forces. shape may also be used, and labels 106A and 106B should be understood to refer to these shapes also. In general any shape may be used which provides turbulence within lumen 1E and/or which tends to propel materials proximally within lumen 1E.

(70) It is noted also that the shapes used in lumen 1E can vary along the length of the lumen. For example, a paddle shape as shown in FIG. 4D could be provided at a distal end of lumen 1E, a propeller shape could be provided distal to the paddle shape along the same axes of lobes 101 and 102, and a helical devices could be provided at more proximal portions of those lobes. If we refer to all these shapes extending the length of lobes 101 and 102 as driving devices, then in some embodiments device 10E may be provided with a variety of driving devices from among which a user may select the combination he wishes to used depending on characteristics of the patient or any particular desired effect or desired optimization of the cleaning process. In general, in some embodiments each driving device is free to rotate within its lobe and/or may be free to independently advance and retract within its lobe, yet each driving device is constrained so that a longitudinal axis of each driving device is retained (by the shape of lumen 1E) within one of the lobes.

(71) FIG. 4E provides an additional alternative embodiment, wherein more than two lobes are used in an exhaust conduit 1F. Note that in these embodiments as well as in the other embodiments shown in FIGS. 4A-4F, each lobe may contain a driving device, or alternatively only some lobes may comprise a driving device and others may be empty of devices and available for the moving exhaust matter itself. FIG. 4E shows a central lobe 103 which comprises a driving device (shown as a helical device 6), while side lobes 101 and 102 are empty.

(72) FIG. 4F shows an embodiment similar to that of FIG. 4E, but wherein a driving device is embodied as a rotatable brush 105 within lobe 103 but whose flexible bristles are long enough to penetrate into side lobes 101 and 102, thus providing empty space in lobes 101 and 102 to facilitate transportation of objects out of the body, while also providing a source for driving power and a source of turbulence and possibly shredding and cutting activities accomplished by bristles from brush 105.

(73) Rotational Tool within an Evacuation Conduit Having a Distal Operating Portion and a Proximal Power Transfer Portion

(74) Various figures of the instant application present helical tools and other rotational tools positioned within an evacuation conduit useable to grain fecal matter and/or to propel it out of the body. In some embodiments such rotational tools extend the length of the evacuation conduit. In some embodiments it has been found efficient to use a tool with a distal operational portion and a proximal power transfer portion whose primary function is to transfer rotational power or other power to the distal portion. FIG. 6C presents such a tool according to some embodiments of the present invention.

(75) FIG. 6C presents a cleaning device 12C which has an exhaust lumen 128 which contains a tool 137 having a distal operational portion 171 designed to grain material and/or to propel said material in a proximal direction within lumen 128. Mechanism 137 also comprises a medial portion 172 which comprises a rope or rod or other flexible connector designed to transfer rotational power from a proximal motor or other energy source (not shown) to distal portion 171.

(76) Using Multiple Conduits and Shaped Conduits to Reduce Overall Cross Section of a Cleaning Device:

(77) A device used to clean a colon must pass the anal spincter and/or a speculum to enter the colon. Once in the colon, the device must be maneuverable within the colon, which includes several sharp curves. A device with reduced cross-section is desirable.

(78) Attention is now drawn to FIGS. 3A-3C, which present cleaning device configurations in which multiple input conduits are used to reduce the device cross-section, according to some embodiments of the present invention.

(79) A cleaning device 10A presented in FIG. 3A comprises an evacuation lumen 1A having a cross-section diameter S1. A housing 3 (for example an extrusion housing) comprises a plurality of fluid input conduits 2 usable to introduce water into a colon. The overall diameter of device 10A is R1. Evacuation lumen 1A may comprise a matter transportation mechanism such as mechanism 137 discussed with reference to FIG. 1.

(80) FIG. 3B presents a cleaning device 10B which comprises an endoscope or a colonoscope 4. Endoscope 4 is constructed together with, or attachable to, an evacuation lumen 1A having a cross-sectional diameter S1. A housing 5, optionally an extrusion housing, comprises a plurality of fluid input conduits 2 usable to insert water into a colon. The maximum diameter of device 10B is the diameter of circle R2 seen in FIG. 3B. Evacuation lumen 1A of FIG. 3B is shown as identical in diameter to evacuation lumen 1A shown in FIG. 3A, yet overall device diameter (the diameter of circle R2 of FIG. 3B) is greater than overall device diameter (the diameter of circle R1) of FIG. 3A. The diameter of a colon is limited, and a large-bore device like that shown in FIG. 3B could be problematic in several respects: it would tend to be stiff, difficult to steer, and could cause pain and retard recovery by damaging the intestinal wall of a patient.

(81) FIG. 3C provides a device 10C which comprises an endoscope 4 and a evacuation lumen 1C shaped as a flattened and slightly curved elipse whose cross-section S3 is shown in the figure. Flattened lumen 1C is advantageous over cylindrical lumen 1A of FIG. 3B because an overall diameter of device 10C (diameter of circle R3 of FIG. 3C) is smaller than the overall diameter (diameter of circle R2) of device 10B, for an identical evacuation lumen cross-sectional area.

(82) Preventing Exposure of Tissue to Excessive Pressure Due to Over-Inflation of an Intestine:

(83) Inserting fluid into a colon (e.g. by use of the devices of FIGS. 6A and 6B) can result in dangerously high fluid pressures within the intestine, possible leading to ruptures or other tissue damage.

(84) Attention is now drawn to FIG. 7A which presents a cleaning device 13A which protects against inducing excessive pressure in an intestine, according to some embodiments of the present invention.

(85) Device 13A is a cleaning device for cleaning an intestine which comprises a conduit for delivering a fluid to said intestine, a pressure sensor 31 operable to measure ambient pressure in said intestine, and a controller 200 configured to control delivery of fluid through said fluid delivery conduit as a function measured intra-intestinal pressure measured by sensor 31.

(86) Device 13A comprises an evacuation conduit 128 which comprises a matter transportation mechanism 137 and a fluid input nozzle 30. FIG. 7A shows a situation in which nozzle 30 is supplying water into an intestine but a large block of feces 32 is preventing conduit 128 from emptying that water from the intestine. A serious rise in pressure in the intestine could result, causing damage and even possible rupture of the intestine.

(87) To prevent excessive pressure in the intestine, 13A comprises a pressure sensor 31 operable to measure ambient pressure in the intestine. Sensor 31 reports to a controller 200 (shown in FIG. 7D). Controller 200 is configured to cease delivery of water through nozzle 30 if pressure measured at sensor 31 becomes dangerously high, or if the measured pressure exceeds some predetermined amount. Alternatively, controller 200 may attempt to solve the problem by applying suction to nozzle 30 to remove water from the intestine, or by purging lumen 128 using methods discussed elsewhere in this disclosure.

(88) Preventing Exposure of Tissue to Dangerously Low Pressure when Suction is Created in an Evacuation Conduit:

(89) If a cleaning device which comprises a matter transportation mechanism 137 within a rapidly transports a large piece of feces away from a distal end of the cleaning device at a time when that distal end is blocked or partially blocked by fecal debris, a vacuum may be produced in the exhaust lumen of the device. Other processes connected with cleaning may also create a strong vacuum within the evacuation conduit.

(90) Such a vacuum can expose intestinal tissues to forces strong enough to draw the tissues into the cleaning device and/or damage those tissues as a result of that strong suction.

(91) FIGS. 7B-11 present a embodiments having features which relate to this problem, according to some embodiments of the present invention.

(92) FIG. 7B presents a cleaning device in which a pressure sensor 311 is positioned within lumen 128, optionally near its distal end. Sensor 311 can be used to detect dangerously low pressure in lumen 128. If, for example, a distal opening of lumen 128 were to come to press up against an intestinal wall 131 as shown in FIG. 7C, preventing fluid from within the intestine from flowing into lumen 128, continued operation of transport mechanism 137 could cause low pressure within lumen 128, particularly if a large piece of fecal matter were rapidly transported along the length of lumen 128 by mechanism 137. To deal with this situation sensor 311 is provided to report to a controller 200 (shown in FIG. 7D) that dangerous low pressure exists in lumen 128. Controller 200 can then be configured to cease operation of mechanism 137 under these circumstances, command purging of the evacuation conduit, or to take any other corrective action available to it.

(93) FIG. 7D shows controller 200 connected and configured so as to be able to control water input to nozzle 30 by means of a valve 202 on the water input supply conduit, and/or to be able to control action of transport mechanism 137, and in particular to cause mechanism 137 to cease operation or to reverse direction if pressure sensor 311 detects a pressure which falls below a predetermined value, indicating a dangerous drop in pressure within lumen 128.

(94) FIGS. 8A and 8B illustrate an alternative method and device for preventing tissue damage caused by a vacuum inadvertently generated in an exhaust lumen 128. FIG. 8A reproduces the dangerous situation discussed in reference to FIG. 7C, where action of a matter transport mechanism 137 within a lumen 128 creates a vacuum and the intestinal wall is drawn towards and into a distal end of lumen 128 and is in danger of being damaged by the suction therein. FIG. 8A shows a construction 1313 where no fluid bypass is present. This may be contrasted to FIG. 8B which presents a configuration 13C according to an embodiment of the present invention, wherein additional and optionally lateral openings 34B to lumen 128 are provided, providing passage into lumen 128 from other portions of the intestine, raising pressure therein. Optionally but preferably, at least one opening 34B is positioned near a water source 220. In case of blockage of distal end 134 of lumen 128 (e.g. by suction drawing an intestinal wall towards opening 134 at a distal end of lumen 128, fluid (optionally provided by source 220) can flow through openings 34B and into lumen 128, thereby reducing the vacuum in lumen 128, thereby preventing damage to the intestinal wall.

(95) FIGS. 9A-9C present an additional advantage of embodiments where water source 220 is directed towards and across opening(s) 34B, according to embodiments of the present invention. It may be understood that if fluid is entering lumen 128 through an opening 34B because of a relative low pressure in lumen 128, it is not unlikely that pieces 22 of feces or other materials may be moved towards opening 34B and may block opening 34B. This situation is shown in FIG. 9B where a large piece of feces 22 has lodged in on opening 34B.

(96) By positioning a water nozzle 220 near opening 34B and aiming jets 221 from that nozzle across opening 34B, this dangerous situation can be resolved, in that water jets 221 from nozzle 220 can be made strong enough to displace pieces 22 which block or which risk blocking opening 34B, as shown in FIG. 9B. FIG. 9C shows the situation after water jet 221 has successfully cleaned opening 34B, which is again open and available to prevent dangerous suction from developing in lumen 128.

(97) An additional configuration enabling to provide fluid in an exhaust lumen when required to prevent excessively low pressure is presented by FIGS. 10A-10D, according to some embodiments of the present invention.

(98) FIGS. 10A-10D present a helical matter transportation mechanism 137 which comprises a hollow central portion 35, according to embodiments of the present invention. Optionally, as shown in FIG. 10A, central portion 35 supports a helical structure 35A mounted on the exterior of a central cylinder 35. That helical structure may be a helical brush 350. Cylinder 35 may be rotated, thereby rotating helical structure 35A and enabling helical structure 35A to function as a matter transportation device 137.

(99) Optionally, cylinder 35 is hollow and serves as a fluid input conduit. Optionally, hollow cylinder 35 comprises a nozzle 35B designed to deliver water or other fluid to an intestine near a distal end of cylinder 35.

(100) FIG. 10B presents a cleaning device 13E which differs from device 13D in that cylinder 35 comprises one or more bypass orifice(s) 36B. An interior lumen of cylinder 35 is connected to a fluid source. In the case that an excessive or dangerous vacuum develops within lumen 128 of device 13E, fluid such as water is enabled to pass from cylinder 35 into lumen 128 through opening(s) 36B, thereby raising pressure within lumen 128 and preventing dangerous levels of suction from developing within lumen 128.

(101) Supply of water or other fluid through orifices 36B may be commanded by a controller in response to signals from a pressure sensor 31. Alternatively, orifices 36B may be provided with an automatic valve (e.g. a rubber flap) near orifices 36B or elsewhere within cylinder 35, enables fluid to flow from cylinder 35 into lumen 128 when a large pressure differential develops between the internal lumen of cylinder 35 and lumen 128, thereby reducing pressure within the evacuation conduit.

(102) FIG. 10C shows device 13E functioning normally, with no fluid passing through orifices 36B, while FIG. 10D shows a situation in which a distal end of lumen 128 is blocked, movement of a large piece of feces 32 is causing suction in lumen 128, and fluid is being drawn from orifices 36B and is reducing that suction.

(103) FIGS. 9A-9C presented what might be called an external bypass, whereby fluid from the intestine may be drawn into an exhaust lumen 128 to reduce a vacuum therein. FIGS. 10A-10D presented what might be called an internal bypass, where fluid from a dedicated source provides a fluid flow directly from that source into the interior of lumen 128 to reduce a vacuum therein.

(104) Attention is now drawn to FIG. 11, which presents another configuration which comprises an internal bypass, according to an embodiment of the present invention. In a cleaner 13F shown in FIG. 11, a dedicated fluid supply channel 37 is used to provide fluid flow into a lumen 128 in case of dangerously low pressure therein. As noted above, control of such a flow can be by means of a controller responding to a sensor, or by means of a valve which opens when a pressure differential exceeds a predetermined amount value.

(105) It is expected that during the life of a patent maturing from this application many relevant endoscopes will be developed, and the scope of the term endoscope is intended to include all such new technologies a priori.

(106) The terms comprises, comprising, includes, including, having and their conjugates mean including but not limited to.

(107) The term consisting of means including and limited to.

(108) As used herein, the singular form a, an and the include plural references unless the context clearly dictates otherwise.

(109) It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

(110) Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

(111) All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.