The present invention relates generally to systems for navigating and imaging body lumens, such as the gastrointestinal (GI) tract, and particularly to a system and method for performing a colonoscopy with self-cleaning features that preclude the need for preparatory cleaning of the colon or assist/clean in cases of poor preparation.
Many imaging devices are known for producing medical images of body lumens, such as the gastrointestinal (GI) tract. For example, endoscopy is widely used for observing, photographing tissue, and taking specimens from lesions and the like. In a conventional method of examining a colon using an endoscope, for example, the endoscope is typically manually inserted into the colon. In this manual technique, patients may often complain of abdominal pain and distention because the colon is extended or excessively dilated, thereby complicating the endoscopic procedure. There may be a risk for the colon to bleed and be accidentally perforated. Insertion of an endoscope through the sigmoid colon and into the descending colon, or through the splenic flexure, the transverse colon, the hepatic flexure or parts affected by previous operations may also be accompanied with difficulty.
The present invention seeks to provide an improved endoscopic device for performing endoscopy in a body lumen comprising a cleaning jet lumen (cleaning includes irrigation and/or washing) that provides a jet of cleaning fluid that cleans said body lumen during imaging thereof, such as the gastrointestinal (GI) tract, as is described more in detail hereinbelow. The invention includes a variety of methods/procedures, such as cleaning while imaging, cleaning during insertion of the endoscope, cleaning while withdrawing, and any combinations thereof. The invention is described hereinbelow with reference to the GI tract, but it is understood that the invention is not limited to the GI tract and may be used for other body lumens as well.
There is thus provided in accordance with an embodiment of the present invention, a method for enhancing performance of an endoscope for use with a body lumen that has not been sufficiently cleaned for viewing with the endoscope, including assembling an endoscopic device to an endoscope, the endoscopic device including a washing member that provides a flow of cleaning fluid for cleaning a body lumen, and a suction member for draining material from the body lumen, and causing fluid to exit the washing member into the body lumen to clear debris away from a path of the endoscope so that the endoscope can view the exposed body lumen, and draining at least a portion of the debris through the suction member.
In accordance with an embodiment of the present invention the endoscopic device is assembled as an add-on accessory to the endoscope. Alternatively, the endoscopic device is assembled with the endoscope as a built-in manufactured assembly.
In accordance with an embodiment of the present invention the method further includes clearing an obstruction from at least one of the washing member and the suction member, such as by causing fluid to exit the washing member and/or the suction member to clear the obstruction.
In accordance with an embodiment of the present invention the method further includes causing fluid to exit the washing member to help propel the endoscope in the body lumen.
In accordance with an embodiment of the present invention the method further includes introducing vibratory motion in the endoscope to help propel the endoscope in the body lumen.
In accordance with an embodiment of the present invention the method further includes introducing percussion forces in the endoscope to help propel the endoscope in the body lumen.
In accordance with an embodiment of the present invention the method further includes fitting a discardable sheath over the endoscope.
In accordance with an embodiment of the present invention the method further includes removing the sheath from the endoscope by inverting the sheath backwards over an end of the endoscope.
In accordance with an embodiment of the present invention the method further includes performing a sequence of alternating between spraying jets of fluid through the washing member to clean away debris in the body lumen, sucking the debris away through the suction member, and cleaning debris away from a drain outlet of the suction member.
In accordance with an embodiment of the present invention the method further includes using a control system to automatically control operational parameters of the sequence, the operational parameters including at least one of time durations of each part of the sequence, and frequency and amplitude of spraying the jets of fluid and sucking the debris.
There is thus provided in accordance with an embodiment of the present invention, an endoscopic device for use with an endoscope, including a washing member that provides a flow of cleaning fluid for cleaning a body lumen, a suction member for draining material from the body lumen, and an anti-clogging element that moves with respect to at least one of the washing member and the suction member for clearing an obstruction from at least one of the washing member and the suction member.
In accordance with an embodiment of the present invention the anti-clogging element includes a spray of fluid that exits the washing member or the suction member.
In accordance with an embodiment of the present invention the endoscopic device further includes a control system for operating the endoscopic device, the control system including a controller, one or more pumps and a control valve, wherein the control valve controls suction to the suction member and the one or more pumps pump cleaning fluid to the washing member. In accordance with an embodiment of the present invention a discardable sheath fits over the endoscope.
The present invention will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which:
Reference is now made to
Referring to
Referring to
The jet spray used to clear the debris is just one example of an anti-clogging element that moves with respect to the washing member 201 and/or suction member 206 for clearing an obstruction from the washing member 201 and/or suction member 206. Alternatively, instead of a fluid element (fluid meaning liquid or gas), the anti-clogging element could be a solid element, such as a probe, needle, pin or other mechanical element, that moves with respect to the washing member 201 and/or suction member 206 for clearing an obstruction from the washing member 201 and/or suction member 206.
Reference is now made to
Referring to
Reference is now made to
In
In
The sleeve mentioned further below is an alternative means for securing the device to the endoscope.
Reference is now made to
Control system 230 may be housed in a control cabinet and may include, without limitation, a power supply 231, controller (processor) 232, one or more pumps 233 (e.g., peristaltic pumps) and one or more control valves 234 (e.g., a pinch valve). Valve 234 is connected to a suction source and controls the suction to the drain lumen 208 of suction member 206. The pumps 233 are used to pump fluid in or out of connector head 211 and suction member 206 and to pump cleaning fluid to washing member 201. The pumps and valve are connected to connector head 211 with tubing 235. The one or more valves 234 may allow switching pressurized washing liquid into the suction drain lumen for unclogging any clog. Such action can be controlled manually or automatically once the controller senses a clog, or in a sequential automatic preventive manner.
The operation of endoscopic device 100 includes pumping a cleaning jet of fluid to washing member 201 for cleaning the GI tract during passage therethrough, typically at low pressure, such as but not limited to, about 2 bar. Waste material (which may flow together with the washing liquid) is sucked into drain lumen 208 and exits to a waste receptacle (not shown) which is preferably disposable.
The cleaning jet can be directed in a variety of directions, such as but not limited to, distally (i.e., forward) to break up clumps and solid waste, proximally (i.e., backwards towards the anus) and to the sides, at angles, or any combination thereof. Control system 230 may be used (e.g., by means of a fluid manifold, fluid switch, electronic valve, etc.) to selectively direct the fluid flow to the cleaning jet lumen 207, drain lumen 208, or debris clearing lumen 209, and/or to selectively direct the jet flow to the forward, side or rear openings of the device. The jet spray can be used to break up and clear away debris from the drain outlet to ensure proper drainage of the fluid used to clean the GI tract. The size of the suction inlet is preferably somewhat smaller than the rest of the path through to the suction outlet so that once debris has passed the inlet it should not cause a clog with the suction lumen.
The jet fluid ensures that any debris, which has become stuck at the suction inlet so as to clog the inlet (because of size or shape), is cleared away from blocking the suction inlet by the force and direction of the flow. The jet fluid avoids sucking the body lumen wall into the suction inlet thus avoiding clogging and potential damage to the body lumen, and also preventing the sucked wall from arresting movement of the endoscope.
A variety of sequence of operations can be used in employing the endoscopic device 100, such as but not limited to, different sequences of alternating between spraying jets of fluid to clean away debris in the GI tract, sucking the debris away, cleaning debris away from the drain outlet, including different time durations of each part of the sequence, frequency and amplitude of the jet sprays and suction, all of which may be automatically controlled by the controller or manually controlled by the operator.
In another embodiment of the invention, all the above-mentioned features/channels/lumens/cleaning jets/suction and the like of the endoscopic device are incorporated within the endoscope itself, that is, supplied or built together with the endoscope by the endoscope manufacturer, or inserted through one or more of available channels within an endoscope.
The lumen for the jet flow to clean the drain may be incorporated in a working channel for passing therethrough working tools (for cutting tissue, collecting biopsy material, etc.).
The work flow may be continuous with a jet flow and suction. Alternatively, the work flow may alternate between jet flow and suction. The work flow may comprise pulses of jet flow, synchronized or not.
The jet flow may be directed proximally to create jet propulsion to propel, or assist in propelling, the endoscope distally into the GI tract. The jet flow may be continuous with suction (and may be used concurrently with the jet flow for cleaning). Alternatively, the work flow may alternate between jet flow and suction. The work flow may comprise pulses of jet flow, synchronized or not.
The suction may take place at a distal portion of the device, on the sides (via suction openings) and/or at a proximal portion of the device, or a combination thereof.
Reference is now made to
Jet steering, jet propulsion or percussion propulsion may be used with the endoscopic accessory.
Reference is now made to
Since a new sheath is placed over the endoscope each time, even if the sheath has a puncture or tear and the endoscope is contaminated, the following patient is protected by a new sheath, thus providing a double safety protection to any treated patient.
As an added protection, as part of the cleaning process of the device after treatment is finished, a second sheath 246 may be placed over the first sheath 244. The second sheath 246 covers and seals the first sheath 244 so that any potential contamination on the first sheath 244 is sealed within the second sheath 246. The far end of the second sheath 246 is attached and sealed onto the far end of the first sheath 244, thus trapping any potential contamination within the closed and sealed sheaths. (The sheaths can be removed from the endoscope by inverting them backwards over the endoscope head, thereby preventing the endoscope from contacting any contaminants.) In this way contamination of the endoscope is prevented. Contamination of the surroundings is also prevented when removing the sheaths. The disposable sheaths once disposed are also sealed thus causing no danger of contamination to any person and equipment involved after completing the colonoscopic procedure.
In an alternative embodiment, the channels are inside the sleeve, and may even be attached to, or part of the sleeve. The sterility of the endoscope is maintained by aseptically sealing the assembly. The sheath may have a transparent window 247 (
The disposable sleeve may contain also one or more working channels to allow medical procedures while keeping the endoscope sterile. The additional working channels may be sufficiently wide for insertion of large tools.
In yet another alternative embodiment, the sleeve itself may be fully transparent allowing undisturbed imaging by the endoscope. In such case, if a working channel of the endoscope is to be used by a surgical tool, or any other tool, the sleeve may be pierced and penetrated by the tool allowing the necessary procedure. Such piercing is doable also during the procedure while the devise is inside the body lumen.
Reference is now made to
The frequency and magnitude of the vibrations can be controlled for the particular situation. Alternatively or additionally, vibratory device 130 can be used in a percussion mode. The motor can be situated within the cabinet unit via proper mechanical connector, or even on or within the endoscope and even at the tip of the endoscope. The motor may be a miniature motor to allow attaching to, or contained within, the endoscope or endoscope tip.
In the illustrated embodiment, vibratory device 130 includes a slender wire that extends partially or fully the length of the cleaning jet lumen, drain lumen, or debris clearing lumen, or which is external to and separate from these lumens (and also can be put inside any working channel of the endoscope, or incorporated into the structure of an endoscope, becoming part of the endoscope). A motor 132 maybe connected to vibratory device 130 for rotation thereof. Vibratory device 130 may be formed with one or more off-center kinks or curves, such as but not limited to, S-shaped curves, such that during rotation the slender wire causes oscillation or any other kind of vibration of endoscopic device 100, along all or part of its length. The wire may be constructed of a material which is sufficiently rigid to create the vibrations, but flexible enough to navigate the various turns of the GI tract (and not disturb/degrade the flexibility and controllability of the endoscope by the user). Examples of suitable materials include, but are not limited to, stainless steel (AISI 316) and nitinol.
The motor may vibrate the vibratory device 130 by rotation motion, linear tangential motion, linear longitudinal motion, or any combination thereof.
Alternatively or additionally, motor 132 may be a percussion type of motor (like a percussion drill motor, for example). When the motor 132 is activated it causes a piston 134 at the distal end of vibratory device 130 to strike a distal end of the endoscopic device 100, thereby causing the endoscope, with endoscopic device 100 attached thereto, to advance distally in the body lumen, similarly to that described above with reference to
Referring to
It is noted that the vibratory device, pistons and other elements of
Vibratory device 130 may be constructed with screw threads and/or grinding or chopping members, similar to the embodiment of
Of course, sensing clogging or blocking can be done even if vibratory devise 130 is not implemented in the system; rather the sensors may be used in simple configurations just with irrigation and suction. Once clogging is sensed, the system may automatically anti-clog the device with a variety of means, such as but not limited to, changing the irrigation/suction routine/sequence/frequency, or increasing suction and/or irrigation pressures and/or flows, or reversing pressure and flow in the opposite directions to release blockages, or more aggressive means, such as vibration, percussion, or changing rotation direction and magnitude.
In accordance with an embodiment of the invention, a similar method of clogging removal may be carried out (as described above with reference to
In this and other embodiments of the invention, lubricants, dyes, marking substances, and/or drugs or other treatment substances may be introduced into guide member 135 and sprayed into the GI tract, e.g., through the cleaning jet lumen or any other port dedicated or not dedicated for such a purpose. Alternatively or additionally, surgical tools, e.g., for cutting and collecting polyps or other tissues for biopsies, may be introduced via guide member 135 or any additional channels. External attachment to the endoscope allows adding more and larger channels and working channels for any necessity.
Various accessories may be mounted at the distal end of vibratory device 130 to enhance its cleaning capability (e.g., to break up debris) and propulsion capability. Some examples are now described with reference to
The grinding tool head 140 of
Instead of the invention being packaged as an add-on accessory, the invention may be built into the endoscope and be provided as part of the endoscope by the endoscope manufacturer.
The invention obviates the need for the aggravating pre-cleaning procedures widely used for preparing for a colonoscopy—no need for enemas, drinking awful tasting glop, diarrhea, etc. Rather the invention starts cleaning the colon upon entering the anus without causing discomfort to the patient. Imaging may be performed while passing the instrument into the colon or while extracting the instrument from the colon.
The following is a summary of a typical, but non-limiting, procedure of using the endoscopic device 100. First, the patient may either skip any pre-cleaning of the colon altogether or may undergo a much shorter and friendlier pre-cleaning, such as a small dosage of an enema.
A sterilized endoscope is prepared by putting/attaching a sterile endoscopic device 100 onto the endoscope (in the case of an add-on accessory). Alternatively, the endoscopic device 100 is pre-manufactured with the endoscope as a built-in manufactured assembly, in which case the manufactured assembly comes sterilized or is sterilized prior to use. Sheath 244 can be part of endoscopic device 100 to maintain sterility.
The endoscope covered with endoscopic device 100 is connected to the endoscope cabinet and the connector head 211 of endoscopic device 100 is connected to the control system 230. Alternatively the endoscope with the endoscopic device 100 built-in is connected to the control system 230. The system is now ready to start the medical procedure.
Next, the endoscope with the endoscopic device 100 is inserted in the colon. Fluid is introduced in the endoscopic device 100 and the jet of fluid starts to clean the path for the endoscope in the colon. The endoscope may take images of the colon as the endoscope enters the colon and/or as the endoscope exits the colon. Any waste material may be collected in a waste container. After imaging and/or other procedures performed with tools through the working channel, the endoscope with endoscopic device 100 is removed from the colon. The second sheath 246 is placed over the first sheath 244 so that any potential contamination on the first sheath 244 is sealed within the second sheath 246. The sheaths are removed from the endoscope by inverting them backwards over the endoscope head, thereby preventing the endoscope and surroundings from contacting any contaminants. The disposable sheaths are then disposed. Any waste material collected during the colonoscopy is sealed in the waste container and disposed.
It will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and subcombinations of the features described hereinabove as well as modifications and variations thereof which would occur to a person of skill in the art upon reading the foregoing description and which are not in the prior art.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US2009/044595 | 5/20/2009 | WO | 00 | 11/18/2010 |
Number | Date | Country | |
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61054510 | May 2008 | US | |
61139647 | Dec 2008 | US |