WATER CYCLING COLONOSCOPY SYSTEM AND METHOD FOR USING SAME

Abstract

The present invention is a system and method for water cycling colonoscopy that includes a colonoscope with a water ejection system and a camera, and a rectal overtube that receives the colonoscope therein. The overtube is placed in the anus and has a vacuum port outside the anus that attaches to a vacuum source. The overtube vacuum port vacuums water emitted by the colonoscope while the colonoscope is moving through the colonic lumen to control the amount of fluid in the colonic lumen. The overtube may be fitted with structures to improve the fit and attachment to the anus, including an inflatable cuff and a flexible skirt.

Claims

1. (canceled) A system for performing a water cycling colonoscopy, comprising: a colonoscope having a camera and a fluid conduit; a vacuum source; an overtube having an inner diameter sized to receive the colonoscope thereinthrough, the overtube having; a tubular element with a flexible skirt extending radially outwardly at an intermediate position, and a vacuum port in fluid communication with the tubular element and connected to the vacuum source for drawing effluent from a body cavity; and a closure covering adapted to seal a proximal end of the overtube while permitting the colonoscope to pass therein.

2. The system of claim 13, further comprising an adhesive coating on the flexible skirt on only a proximal facing surface.

3. The system of claim 2, wherein the closure covering includes a circular hole that allows for passage of the colonoscope while maintaining a seal around the colonoscope.

4. The system of claim 13, further comprising an introducer sized to pass through the overtube and adapted to expand tissue surrounding an anus for insertion of the overtube.

5. The system of claim 13, wherein the vacuum port is disposed on a portion of the overtube, said portion configured to rotate three hundred sixty degrees about a longitudinal axis with respect to a remaining portion of the overtube.

6. The system of claim 13, wherein a portion of the overtube adapted to be inserted into a patient is inflatable to an open position from a deflated, closed position while inside the patient.

7. The system of claim 13, further comprising a manual flow control valve configured to adjust a flow rate through the tubular element.

8. The system of claim 7, wherein the manual flow control valve comprises a thumb wheel.

9. The system of claim 13, further comprising a bracket mounted on the overtube adjacent a proximal end of the overtube, the bracket adapted to secure an emesis bag below a proximal opening of the overtube.

10. The system of claim 9, further comprising an emesis bag and a removable screen cooperating with the emesis bag to collect solid objects exiting the overtube through the proximal opening.

11. The system of claim 9, wherein the bracket includes first and second arms that form a semi-circular support with a channel.

12. The system of claim 13, wherein the fluidic vacuum source is connected to both the vacuum tube of the overtube and the colonoscope.

13. A system for performing a water cycling colonoscopy, comprising: a colonoscope having a camera and a fluid conduit; a fluidic vacuum source configured to withdraw fluid from a body cavity; and an overtube configured to receive the colonoscope at a proximal end and extend the colonoscope through a distal end, the overtube comprising: a vacuum tube fluidly connected to the overtube's interior volume and the fluidic vacuum source, the vacuum tube configured to pass fluid in the overtube therein through; a frustoconical portion; a flexible skirt disposed between the vacuum tube and the frustoconical portion, the distal skirt abutting the frustoconical portion and having an outer diameter greater than an outer diameter of the frustoconical portion; and a removeable closure covering enclosing a proximal end of the overtube, the removeable closure covering proximal to the vacuum tube.

14. The system of claim 13, further comprising an inflatable cuff at a distal end of the overtube, said inflatable cuff expandable from a closed frustoconical shape to an open funnel shape.

15. The system of claim 13, further comprising a thumbwheel configured to adjust a syphon flow of effluent through the vacuum tube.

16. The system of claim 13, wherein the fluidic vacuum source is a manual pump that induces syphonic action to remove fluid from the patient.

Description

DESCRIPTION OF THE FIGURES

[0046] FIG. 1 is a schematic diagram of the colon and colonoscope configured for water exchange colonoscopy using the present invention;

[0047] FIG. 2 is an elevated, perspective view of a first embodiment of an overtube and introducer of the present invention;

[0048] FIG. 3 is a cross sectional view of an overtube and introducer;

[0049] FIG. 4 is an enlarged, cross sectional view of the overtube and sealing cap;

[0050] FIG. 5 is a cross sectional view of the overtube and sealing cap;

[0051] FIG. 6 is a cross sectional view of the overtube and sealing cap with a vacuum source attached to the vacuum port;

[0052] FIG. 7 is the embodiment of FIG. 6 shown in the anus with a colonoscope in the overtube;

[0053] FIG. 8A illustrates an alternate embodiment of an overtube of the present invention in a closed configuration;

[0054] FIG. 8B illustrates an enlarged view of the alternate embodiment of the overtube of FIG. 8A in the open configuration;

[0055] FIG. 9A illustrates a manual flow control mechanism of the present invention;

[0056] FIG. 9B shows the manual flow control mechanism of FIG. 9A is the closed position;

[0057] FIG. 10 is an illustration of the system of the present invention with a first draining system; and

[0058] FIG. 11 is an illustration of the system of the present invention with a bracket assembly for connecting an emesis bag.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0059] The present invention solves a critical problem found with standard WE and WI colonoscopy, namely the sole dependence on the water infusion and water, waste, and air suction capabilities of the colono scope to perform effluent exchange. Water Cycling Colonoscopy moves the vacuum system for colonic waste, air, water, sediment, and sludge from the colonoscope to the anal canal using a short overtube system for both a new vacuum system and colonoscope insertion port. The insertion port at the entrance to the overtube can also serve as a site for removal of polyps, stool, blood, foreign material and other GI related materials. This system uses the close dimensions of its outer diameter to the anal canal and an air and water-tight seal from its attachment to the perineum to address and minimize leakage. This in turn makes the colon, with the exception of the ileocecal valve, substantially a closed system. It further presents an opportunity for greater and more sensitive monitoring and adjusting of the volume and dimensions (diameter and length) of the colon.

[0060] As seen in FIG. 1, an overly simplified patient colon system 10 is shown with a colonoscope 12 inserted and extended to a distal position in the right colon. The colonoscope 12 is equipped with a water port 16 at a distal end 14 for introducing clean, fresh water at the distal position shown in FIG. 1. The port for the biopsy/vacuum channel on the end of the colonoscope 16A is the dedicated vacuum port for the colonoscope. The water cleans the inner walls of the colonic lumen while a camera sends images to a remote screen being viewed by the colonoscopist. The accumulating water infused from the distal end 14 of the colonoscope 12 serves to inflate the colon 10 and expand the folds and crevices of the wall to allow better observation via the camera 19. The colonoscope is equipped with a biopsy/vacuum port 16A to be used for procedures (polypectomy, biopsy, hemostasis, repair of mucosal trauma, and endomucosal resection), trapped gas removal and only sparingly, for fluid removal.

[0061] During Water Cycling Colonoscopy, clean, clear water is pumped through the colonoscopy and into the body lumen immediately upon insertion at the rectum 18. Special attention is paid to the use of higher water infusion volumes and infusion flow rates. The relationship of the more localized and controlled hydrostatic effect on colonic distention to pain is of particular importance. Simultaneous removal of residual air is performed to aid in water infusion and better control of colonic distention. A foot pedal (not shown) may adjust the water infusion through the colonoscope, while vacuum for air removal is actuated by a vacuum control on the colonoscope control handle. Water removal from residual colonic preparation, infused water (clear or soiled), sediment, sludge, and fragmented stool, is accomplished by suction through the overtube 20. This may be performed using a vacuum source 24 that imposes a negative pressure at the entrance of the vacuum port 22 on the overtube 20 via a vacuum tube 26. The vacuum source 24 may be controlled by using a manually controlled valve such as, for example, by a trumpet-type finger control attached to the control handle of the colonoscope. The vacuum source 24 may be a standard wall vacuum unit, common in the hospital and clinic procedures room setting, or a portable unit of the type commonly used in surgery, intensive care units and outpatient procedure settings. This draws the effluent materials away from the colonoscope 12 and the area of the water jet and objective lens at the distal end 14 of the colonoscope 12, through the colon and into the overtube 20, and from there into the vacuum waste collection receptacle (not shown). This system can easily be varied or alternated from totally infusion to totally suction to modulate between the two.

[0062] The system of the present invention produces a more effective cleansing and visualization of the mucosa. This is accomplished by constantly infusing clear, clean water from the distal end of the colonoscope 12 coordinated with a constant suction removal of accumulating dirty water, sediment, sludge and fecal material away from the distal end of the colonoscope insertion tube, specifically, the objective lens of camera 19, into the rectal overtube 20 and out through the vacuum system into a waste receptacle. This produces better and quicker visualization of the colonic wall (mucosa) and frees the water infusion lumen 16 of the colonoscope 12 by not drawing the waste back into the colonoscope's biopsy/vacuum port 16A just millimeters away from the lens. This quicker, more accurate site picture is better for seeing potential lesions (polyps, cancer), mucosal pathology (colitis, vascular malformations), and defining strictures, adhesions and colonic malrotation.

[0063] Enhanced visualization of the colonic lumen and mucosa using a localized hydrostatic effect and shear force of the water jet helps the colonoscopist to more carefully distend and maintain the colon at a narrower diameter. This acts so as not to efface small, sessile polyps or lesions by “stretching out” the mucosa. The present invention also allows easier transition of the colonic insertion tube through a minimally, yet adequately, distended and elongated colon and into the cecum. This is related to the shared localized hydrostatic ability with water exchange/removal to prevent colonic dilation, lengthening, angulation, exaggeration of colonic tortuosity and ensuing colonoscopic looping. Particularly significant, this also produces much less pain and discomfort for the patient. Directing the waste away from the biopsy/vacuum port 16A prevents it and its channel in the insertion tube from becoming clogged which hampers interventional colonoscopy, air pocket removal and the necessity of cleaning the channel or replacing the colonoscope in the middle of the procedure or halting the procedure all together.

[0064] Stool retention in the channel may produce problems in cleansing the colonoscope, potentially damaging the colonoscope and causing potential infection risks. Infusion of water and vacuum removal by the system can be done not only upon insertion but during removal of the colonoscope, enhancing cleansing and potentially increasing ADR/PDR. Higher flow rates of water infusion increases the shear forces on the colon wall, which in turn allows for even better cleansing of the colon to enhance the surveillance capability of the colonoscope and water magnification effect improving visualization of small lesions on both insertion and removal of the colonoscope. Continuous flow of clear, clean water at higher infusion rates with constant removal of effluent or variations of these gives a more immediate clearer picture of the colon and mucosa. It provides a better, quicker, more accurate evaluation of the colon and its pathology and more rapid progression to the cecum. This is time saving, which alleviates the problematic prolonged insertion time caused by repetitive water instillation and suction through the vacuum port of the colonoscope.

[0065] The continuous flow system is helpful in the case of a poorly prepared colon. Most studies cite from 25-30% of colonoscopies as having inadequate preparation. This would be in the range in the US from between 4,750,000-5,700,000 colonoscopic procedures per year. Successful application of the present invention to the problem of poor preparation would be both medically and financially efficacious. The sealed nature of the system works well for aggressive cleansing yet maintaining cleanliness of the patient and endoscopy suite. The present invention also allows for high water flow into and out of the colon, increasing visual capability and reducing the number of failed or repeated procedures. The water flow rate also keeps the lens field of view clear of stool, blood, and debris, improving visual quality and maximizing the magnification effect of the water.

[0066] FIG. 2 illustrates one example of an overtube used in connection with the present invention. In one preferred embodiment, the overtube 20 is approximately ten centimeters in length and caries an outer diameter of approximately 2.5 centimeters. The overtube 20 includes a thin-walled flexible skirt 30 attached to the tubular element 32. The outer surface 34 of the skirt around the periphery may include an adhesive material 35 that helps the skirt attach to the patient's dermis to form a substantially air-tight and water-tight seal. The skirt also forms a stop to help position the overtube 20 in proper position within the anal canal (see FIG. 7). To facilitate insertion of the overtube 20 into the anal canal, one may employ a specifically constructed introducer 40 in a fashion similar to an anoscope. The introducer 40 is formed with a rounded distal end 42 with a diameter that fits within the inner diameter D of the overtube 20. The introducer 40 is inserted into the overtube 20, such that the distal end 42 protruded through the overtube 20 (see FIG. 3). The introducer/overtube combination is inserted into the anus to prevent the soft tissues of the anus and anal canal from being injured by the edges of the open end of the overtube 20. The introducer 40 is then withdrawn, leaving the overtube inserted in the anus so that the colonoscope can then be inserted. The system also includes a cap 56 that can be used to cover the overtube's entrance once the colonoscope is removed to seal the colonoscope and allow the vacuum to continue to remove fluid post removal of the colonoscope 12.

[0067] The fit of the overtube 20 and the incorporation of the thin walled skirt 30 and adhesive coating serves to seal the anal opening against the overtube for both air and water leakage. The skirt 30 allows the overtube to be inserted into the anal canal to seal the canal in a “plug-like” fashion. Once inserted and anchored into proper position, the proximal end of the overtube 20 is covered with a thin flexible membrane covering 50 having a central opening 54 through which the colonoscope 12 is inserted. The membrane wall 52 may be covered by a hydromer that enhances the passage of the insertion tube of the colonoscope forward and backward without losing the seal about the colonoscope.

[0068] The overtube 20 is a cylinder of approximately 2.5 centimeters in outer diameter and 10 centimeters in length, and a wall thickness of between 1-2 millimeters. It may be constructed of an elastomer to be semi rigid with slight to moderate flexibility and compressibility. The distal segment 36 is inserted into the anal canal up to the skirt 30 and remains there throughout the procedure. It serves as a conduit for the passage of the introducer 40 and the colonoscope 12 into the patient. The distal segment 36 is specially adapted to fit snuggly to establish an air-tight and water-tight seal while favoring passage of air, water, sediment, sludge, fecal material, polyps and foreign material through the tube. The proximal or external segment 38 is purposed for being the site of waste removal and colonoscope insertion.

[0069] Waste removal is accomplished in large part using a vacuum port 22. This has removable fittings (not shown) at the vacuum attachment site for connecting to standard vacuum tubing 26 of the type used in endoscopy suites and medical centers. Removability is also important to clear any blockage at or above the point of attachment should this happen while vacuuming of the waste material during the procedure. Waste is vacuumed by either a separate vacuum source 24, portable or standard wall type vacuum unit, or a “Y” type connector so that both vacuum systems of the overtube 20 and colonoscope 12 may share the same vacuum source. This proves useful where extra vacuum sources are unavailable at the time of the procedure. The vacuum system may use a trumpet type valve (not shown) to open and close the overtube 20 to the vacuum source 24. It is attached by ties and a tacky surface on the trumpet valve to the control handle of the colonoscope in an ergonomic fashion. The valve is easy to connect and disconnect from the ties to the control handle. The system is operated by one finger which is within a few centimeters of the related controls of the colonoscope.

[0070] The overtube's proximal end includes an opening or port 23 that may be approximately 2.5 cm in outer diameter with a wall thickness of 2 millimeters and has a removable membrane covering 50 made of a thin, flexible polymer membrane made of or covered with a high coefficient of friction material. The central opening for insertion of the colonoscope insertion tube is 0.8 to 1.3 centimeters in diameter, close enough for the colonoscope insertion tube to have a close air to water seal yet move easily due to the low coefficient of friction of the material. This opening allows for the performance of the usual diagnostic (biopsy, polypectomy, endomucosal resection) and therapeutic (hemostasis, colonic wall repair, volvulus reversal) colonoscopic procedures. The opening 23 also serves as an auxiliary drainage port for stool and effluent. The cap 50 is removable to allow for polyp extraction, foreign body removal, problematic waste disposal etc., without need to remove the overtube 20.

[0071] The vacuum port 22 may be positioned about 0.5 cm above the opening to the colonoscope introducer port for better drainage. It is positioned in the most proximal 2 cm of the overtube 20 on a cylindrical element 38 that can be twisted independently from the rest of the overtube through 360 degrees (see FIG. 6). This rotation keeps the waste removal port available in any suitable position for good drainage and prevents the drainage line from getting “wrapped around” the patient in the event the patient's position needs to be changed during the colonoscopy. Cap 56 occludes the overtube once the colonoscope is removed to cover opening 23.

[0072] FIG. 7 shows the overtube 20 in the patient with the colonoscope passing through the overtube. The overtube forms a fluid tight seal with the anus, and the effluent is vacuumed out the vacuum port 22 and into tube 26, where it can be collected and discarded into a bag or container. The skirt 30 attaches to the patient's buttocks and helps to seal the overtube 20 with the tissue surrounding the anus, and the adhesive coating on the surface of the skirt 30 further enhances the contact and limits leakage.

[0073] An alternate configuration of the overtube is shown in FIG. 8A,B and includes a low-pressure water or air inflatable cuff 60 for overtube placement and retention in the anal canal, and to help further assure prevention of air and fluid leakage around the overtube 20. The cuff 60 attaches to the end of the distal opening 62 of the overtube 20 and in the closed state surrounds both the most distal portion of the overtube and the colonoscope 12 as well. This closes the annular gap between the insertion tube 64 of the colonoscope 12 and the inner wall of the overtube. Closure of this space prevents trauma to the mucosa of the anal canal on insertion of the overtube as well as possibly obviating the need for a dedicated introducer 40. The structure now becomes a single, smooth overtube-insertion unit free of areas which would catch on the anatomy of the anal canal. Inflation of the cuff 60 through an inflation port 66 on the mid portion of the overtube via a tube 68 connecting the port 66 to the cuff 60 opens the distal opening of the overtube (reminiscent of a flower, see FIG. 8B) to permit fluid and air removal, as well as providing another anchoring point for placement and retention of the overtube 20 and establishing a seal against air and fluid leakage around the overtube.

[0074] When the cuff 60 is open as shown in FIG. 8B, it anchors the overtube 20 in place and cooperates with the skirt 30 to more precisely position and stabilize the overtube. Using the cuff 60 as described may obviate the need for an adhesive coating on the skirt to hold the overtube in place. The water or air inflation of the cuff 60 is atraumatic to the mucosal and other anatomic structures in the anal canal and proximal rectum. Varying the inflation of the cuff 60 can adjust the fit of the overtube 20 with anal canals of varying lengths.

[0075] Removing the waste material can take several forms. When a siphoning action is used, the effluent flow rate may be controlled by a wheel type flow control system (FIGS. 9A, 9B). A wheel 122 is mounted on an inclined guide 124 proximal to the effluent syphon tube 120, where rotation of the wheel 122 such as by use of the thumb rolls the wheel 122 into contact with the tube 120. Further rotation pushes the wheel into engagement with the tube, collapsing the tube and constricting the flow of fluid and effluent in the tube (FIG. 9B). Fully rotating the wheel to the end of the rail substantially closes the tube 120, thereby providing complete control over the flow through the tube. Such a device, by its compression of the effluent tube 120, changes flow by a fourth power of the radius. Decreasing the radius by half decreases flow to one-sixteenth of the original value (Poiseuille's Law). Such a system allows for simple yet sensitive control of effluent flow, balancing waste removal against proper fluid inflation and cleansing of the colon.

[0076] FIG. 10 illustrates an alternate flow control for the system of the present invention. This new lavage fluid and waste removal technique makes use of the intraabdominal and intracolonic pressure produced by the abdominal wall, viscera, colonic wall, and luminal water level in the closed system of the colon due to the presence of the sealed overtube 20. A drainage line 150 extends from the overtube 20 to a receptacle 160, either open or closed, on the floor or a position lower than that of the patient (siphonic physics-Bernoulli Equation). This produces a siphonic action using extraluminal and intraluminal (fluid) pressure and gravity aided by the sealed nature of the system to help initiate a constant outflow of fluid and waste. The more fluid, the more pressure, the more cleansing action, and better waste removal not to mention a cleaner procedure. Flow rate through the drainage tube is adjustable to balance water infusion and waste removal to maintain proper colonic luminal dilation for better observation and procedure performance as well as cleansing.

[0077] To assist in the establishment, maintenance and if necessary, reestablishment of siphonic action in the water/waste removal line, an integral squeeze-type balloon pump 170 may be used. This is useful to keep the line free from obstruction from blood, stool and other materials as well as maintain or reinitiate siphonic action. The balloon pump 170 includes two one-way valves, defaulted to an open position, that allows normal free fluid flow through the pump but close appropriately when necessary, to establish fluid and waste flow and remove obstruction in the line. This technique uses principals of physics to affect siphonic fluids/waste removal as previously mentioned in absence of a dedicated ancillary vacuum system. The system is easy to setup and use, is of a simple design using no moving parts. It places minimal demands on material needs and staff interventions.

[0078] Keeping the colonoscope in proper position and with the removal of the insertion port covering 50 by sliding it backward from the port 23 over the colonoscope insertion tube toward the colonoscope control handle opens a wider site egress for waste material (approximately 2.0 to 2.1 centimeters in diameter). Constant water infusion from the water jet distal end of the insertion tube produces an enema effect to flush out residual liquid and solid waste through the open insertion opening 23 that would be problematic for the smaller vacuum port 22 of the overtube 20. The insertion port covering 50 could be easily slid back into position over the colonoscope and resealed.

[0079] The cap 56 is used to close the central opening in the insertion port. This helps to retain water and prevent air from entering the colon should the colonoscopist wish to remove and then reinsert the colonoscope to continue the procedure.

[0080] FIG. 11 further illustrates how the effluent flow can be directed out of the overtube through the opening 23. This mode makes use of a bracket attachment 182 on the overtube which holds an emesis bag 200 in proper position to collect waste effluent when the flexible covering over the colonoscope insertion port is removed. The bracket attachment 182 is mounted on the overtube adjacent to its proximal end to secure the emesis bag 200 below the opening 23 of the overtube 20. The bracket attachment 182 may include first and second arms 184 that form a semi-circular support with a channel 185 that receives a rim 186 of the emesis bag 200 therebetween. This is especially useful in maintaining the cleanliness of the endoscopy suite, endoscopy platform (table, gurney, or bed) and the patient during polyp removal, foreign body removal, removal of waste material too large or viscous to be cleared through the waste port or clearance of waste obstructing the entrance to the waste port from the overtube. A screen attachment 190 which is inserted into the opening of the emesis bag strains for polyps or other material which could not pass through the vacuum channel or were lost during the removal process. The bracket attachment 182 clamps onto the overtube 20 using a hinged clamp 194 that can quickly be released and disconnected from the overtube for removing or replacing the bag 200.

[0081] While this disclosure has described and depicted multiple embodiments of the present invention, it is to be understood that the invention is not limited to any single embodiment or depiction. Rather, the various features and elements of the disclosure are understood to be combinable where appropriate to create various combinations and arrangements of the various elements of the invention. Thus, nothing in this disclosure should be construed as limited to any particular embodiment shown or described.