BACKGROUND

[0001] This application claims the benefit of earlier filed United States Provisional Patent Application No. 62/517,827 filed June 09, 2017 for Device for Cleaning Proximal Portion of Body Cavity. The '827 application including the appendices are incorporated by reference herein.

[0002] Field of the Disclosure.

[0003] This disclosure relates generally to medical devices and methods, more particularly to devices and methods to clean contaminated body cavities including cleaning the lower end of the gastrointestinal (GI) tract.

[0004] Vocabulary.

[0005] In this disclosure and the claims associated with this disclosure, the term proximal is defined relative to the user of the device. So the proximal end would be closer to the user of the device and the distal end may be inserted into the body cavity.

[0006] In this disclosure and the claims associated with this disclosure, the term set may apply to a set of just one item or a set of more than one item.

[0007] In this disclosure and the claims associated with this disclosure, the terms distal and proximal are defined with respect to the health care provider using the device. So proximal would be towards the health care provider and distal would away from the health care provider and possibly inserted into the body cavity.

[0008] Related Art.

[0009] United States Patent Application No. 14/959,908 filed December 04, 2015 is was published as Publication No. US 2016/0158423 Al on June 09, 2016 with the title Devices and Methods for Cleaning Contaminated Body Cavities teaches a device that may be used for lavaging (rinsing and washing out) contaminated body cavities. The '908 application is incorporated by reference herein. [0010] As noted in the '908 application, there are a range of treatments of the lower GI tract that require insertion of equipment. Visualization of the lower GI tract or just the ability to insert medical equipment into the lower GI tract can be impaired by the presence of mucus secretions, fecal matter, blood, bacteria, undigested food, or other material. The '908 application suggested a body cavity cleansing device 50 for cleaning the lower GI tract as shown in FIG. 1.

[0011] The prior art device 50 includes housing 54, a first cannula 58 and a second cannula 62. The distal end 66 of the prior art device 50 may be inserted into a cavity to flush the nearby volume of the cavity and remove material. A primary use of such a prior art device 50 is to insert the distal end 66 of the device through the anus to gain access to the space within the rectum and possibly further into colon.

[0012] The housing 54 on prior art device 50 may be substantially cylindrical with a domed distal end 66. The device may have a moveable flange 70 that is used as a splash guard.

[0013] Near the distal end 66 are a first set of openings 78 which are in fluid communication with the first cannula 58 which is connected to a vacuum source (not shown). Thus, when the device is inserted, the first set of openings 78 may be connected to a vacuum source to remove material through the first set of openings 78, through a first passageway 88 (shown in next figure) in the housing 54 and through the first cannula 58 and any control devices to the vacuum source.

[0014] Between the first set of openings 78 and the distal end 66 of the prior art device 50 is a second set of openings 82. The second set of openings 82 may be connected to a pressurized fluid source by the second cannula 62. The fluid may be sterile water or saline solution appropriate for introduction into the body cavity to irrigate the body cavity and cause movement of material towards the first set of openings 78 so that the vacuum source may pull material out of the body cavity.

[0015] As would be appreciated by one of skill in the art, the first passageway 88 within the housing 54 connecting the first set of openings 78 and the vacuum source connected to the first cannula 58 must be isolated from the second passageway 92 within the housing 54 connecting the second set of openings 82 with the source of pressurized fluid connected to the second cannula 62. [0016] FIG. 2 shows the first passageway 88 and second passageway 92. Second passageway 92 is essentially an extension of second cannula 62 to provide pressurized fluid the second set of openings 82 which are the most distal set of openings. A distal portion 98 of first passageway 88 is essentially the interior of housing 54 and minus the second passageway 88 as it travels to a chamber 72 which serves to distribute the pressurized fluid to the second set of openings 82. However, there is a transition 68 between the distal portion 98 of the first passageway 88 and a proximal portion 48 of the first passageway 88. Material sucked into the distal portion 98 of the first passageway 88 through the first set of openings 78 may have difficulty entering through transition 68 from the annular chamber of the distal portion 98 to the proximal portion 48 which is within housing 54 but no larger than first cannula 58.

[0017] To convey a sense of scale, it may be useful to note that the '908 application teaches that the first set of openings 78 may have diameters in the range of 4 millimeters, and the second set of openings 82 may have diameters in the range of 2 millimeters. As would be appreciated by those of skill in the art, having relatively small openings for the second set of openings 82 will allow a higher discharge velocity of the pressurized fluid for a given volume of delivered fluid for a given number of openings. Having a relatively large number of relatively small openings may be desirable for providing a number of discharge flows in different directions while not using a tremendous amount of fluid.

[0018] Unless explicit to the contrary, the word "or" should be interpreted as an inclusive or rather than an exclusive or. Thus, the default meaning of or should be the same as the more awkward and/or.

[0019] The terms proximal and distal as used in connection with medical devices are used in the conventional manner. Thus proximal is closer to the operator of the device and distal is further away from the operator of the device.

SUMMARY OF THE DISCLOSURE

[0020] This summary is meant to provide an introduction to the concepts that are disclosed within the specification without being an exhaustive list of the many teachings and variations upon those teachings that are provided in the extended discussion within this disclosure. Thus, the contents of this summary should not be used to limit the scope of the claims that follow.

[0021] Inventive concepts are illustrated in a series of examples, some examples showing more than one inventive concept. Individual inventive concepts can be implemented without implementing all details provided in a particular example. It is not necessary to provide examples of every possible combination of the inventive concepts provide below as one of skill in the art will recognize that inventive concepts illustrated in various examples can be combined together in order to address a specific application.

[0022] Other systems, methods, features and advantages of the disclosed teachings will be immediately apparent or will become apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be included within the scope of and be protected by the accompanying claims.

BRIEF DESCRIPTION OF THE FIGURES

[0023] The disclosure can be better understood with reference to the following figures. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the disclosure. Moreover, in the figures, like reference numerals designate corresponding parts throughout the different views.

[0024] FIG. 1 shows a prior art body cavity cleansing device 50 for cleaning the lower GI tract.

[0025] FIG. 2 shows the first passageway 88 and second passageway 92 for a prior art device.

[0026] FIG. 3 shows an improved device 100 for lavaging an opening to a body cavity such as the opening to the lower GI tract.

[0027] FIG. 4 is a longitudinal cross section of FIG. 3.

[0028] FIG. 5 is a longitudinal cross section of distal section 104 that has been rotated slightly to make certain components visible.

[0029] FIG. 6 shows distal section 104 without a cross section. [0030] FIG. 7 shows a first view of prior art device 500.

[0031] FIG. 8 is a longitudinal cross section of prior art device 500.

[0032] FIG. 9 is an enlarged portion of the longitudinal cross section of prior art device 500 shown in FIG. 7.

[0033] FIG. 10 shows a prototype created to implement the fluid flow properties of the embodiment from the '908 application shown in FIGs. 12-14 of the '908 application.

[0034] FIG. 11 provides a perspective view of a cross-section of device 504 taken distal to the flange 570.

[0035] FIG. 12 is the cross section of device 100 previously shown in FIG. 4 but with fewer element numbers to minimize clutter.

[0036] FIG. 13 is a cross section of an earlier version of this device.

[0037] FIG. 14 shows device 300 which is device 100 with the addition of a third port such as needleless injection port 304.

[0038] FIG. 15 provides a flow chart for method 1000 for a process of removing material from a body cavity.

DETAILED DESCRIPTION

[0039] FIG. 3 shows an improved device 100 for lavaging an opening to a body cavity such as the opening to the lower GI tract. The device 100 has a distal section 104 and a medial section 108 for insertion into the body cavity. Proximal relative to flange 120, the device has a proximal section 112 and an exit tube 116 that are not inserted into the body cavity.

[0040] As described in more detail below, a fluid supply tube 130 is in fluid connection with a set of fluid ports 134 near the distal tip 138 of the device 100. As described in more detail below, the open end 140 of the exit tube 116 may be connected to a vacuum source (not shown) to pull material into a set of vacuum ports 144 which are relatively close to the distal tip 138 but not as distal as the fluid ports 134. Note that the prior art device 50 which had rows and rows of openings for the first set of openings 74 and the second set of openings 78 and thus had openings connected to vacuum a considerable distance from the distal end 66 of prior art device 50. In marked contrast, device 100 has one row of fluid ports 134 and one row of vacuum ports 144 so that all vacuum ports may be within the body soon after inserting the distal tip 138 so that vacuum force is not depleted by having vacuum ports outside of the body passing air into the vacuum system. [0041] FIG. 4 is a longitudinal cross section of FIG. 3. Visible in FIG. 4 is a threaded connection 150 that connects distal section 104 to medial section 108. Also visible in FIG. 4 is a threaded connection 154 that connects medial section 108 to proximal section 112. The distal end 160 of exit tube 116 is stretched to fit over a proximal portion 164 of proximal section 112. The proximal portion 164 may have a small flange 168, rib or other shape known to those of skill in the art to retain the distal end 160 of the exit tube 116.

[0042] The open proximal end 170 of the fluid supply tube 130 may be connected to a fluid supply. The connection between the fluid supply tube 130 and the fluid supply may include controls to regulate the amount of fluid supplied to the fluid supply tube 130. Moving from the open proximal end 170 of the fluid supply tube 130 in a distal direction, the fluid supply tube enters into the cavity 148 of the device 100 through channel 174. The interior diameter of the channel 174 is substantially the same as the outer diameter of the fluid supply tube 130 so that significant amounts of air do not leak between the fluid supply tube 130 and the channel 174 to decrease the suction at vacuum ports 144.

[0043] A distal section 178 of the fluid supply tube 130 fits over raised portions 188 of the fluid header 184 near the open proximal end 192 of the fluid header 184. Thus, fluid entering the open proximal end 170 of the fluid supply tube 130 passes through the supply tube within the cavity 148 of the device 100 and passes through the open proximal end 192 into the fluid header 184 and exits one of the four fluid ports 134. The fluid in the fluid supply tube 130 is isolated from the vacuum path within the cavity 148 between the vacuum ports 144 and the open end 140 of the exit tube 116.

[0044] FIG. 5 is a longitudinal cross section of distal section 104 that has been rotated slightly to make certain components visible. The male threads 204 that connect with female threads in the medial section 108 form the threaded connection 150 that connects distal section 104 to medial section 108 (See FIG. 4). The proximal end 208 of the fluid header 184 has the open proximal end 192 and raised portions 188.

[0045] In FIG. 5, three of the four fluid ports 134 are visible. Two of the fluid ports 134 are cut by the cross section and are aligned close to vertical. For each of these two fluid ports 134, the flared opening 228 is visible. A third fluid port 134 is visible in fluid header 184 and exits into the page away from the viewer. The fourth fluid port 134 open towards the viewer is in the half of the distal section 104 removed in the cross section.

[0046] FIG. 5 also shows three of the four vacuum ports 144. Two vacuum ports 144 are cut by the cross section. A third vacuum port 144 is partially visible behind the fluid header 184 and opens into the page away from the viewer. The fourth vacuum port 144 that would be oriented open towards the viewer has been removed with the cross section.

[0047] Note that the open ends of the vacuum ports 144 and the flared openings 228 of the fluid ports 134 are in each in one of the four recessed zones 220 (See also FIG. 3).

[0048] Phantom lines 299 are just an artifact of the CAD program image and do not represent a distinct structure.

[0049] FIG. 6 shows distal section 104 without a cross section. Visible in FIG. 6 are male threads 204, recessed zone 220, fluid port 134 and flared opening 228 of the fluid port 134. Notice the vacuum port 144 also has an enlarged surface perimeter 244 although the percent of increase is small relative to fluid port 134 and flared opening 228.

[0050] Velocity Profiles.

[0051] Putting aside the secondary consideration of losses due to friction losses within the short runs of piping, velocity will vary with cross sectional area. For one prototype built in keeping with the teachings of the present disclosure the relative velocities will be as shown in Table 1.

[0052] TABLE 1.

Within the set of four fluid Total-0.12 Square Inches 4.1V ports 134(FIG. 3)

[0053] Perhaps more importantly, the cross sectional area on the vacuum side decreases from the vacuum port 144 to the proximal portion 164 of the proximal section 112. Decreases in velocity could lead to solid items that entered the vacuum port falling out of the vacuum flow stream and starting to obstruct the flow path. Table 2 shows the relative cross sectional areas and relative velocities.

[0054] TABLE 2.

[0055] Second Device from '908 application.

[0056] The '908 application includes another embodiment as shown in FIGs. 12-14 of the '908 application. As described in more detail below, this embodiment has a pair of concentric walls with arrays of holes for the vacuum path from outside of the device to the interior channel connected to a vacuum source. This embodiment merits a brief discussion as a prototype of this embodiment was created and tested against the device 100 of the present disclosure. As indicated below, device 100 had superior results as compared to the prototype made in accordance with FIGs. 12-14 of the '908 application. [0057] FIG. 7 shows a first view of prior art device 500. Prior art device 500 has a housing 554. As with prior art device 50 within housing 554 there is a second path for the provision of pressurized fluid such as sterile water or saline to a second set of openings 582 near the distal tip 566 of the device 500. Note that the second set of openings 582 extend into the domed portion 568 of the device. Note also that the openings in the second set of openings are not evenly distributed around the circumference of the device 500 but have at least one gap 584. A second cannula 562 providing the pressurized fluid may be connected to a second port 564.

[0058] Likewise, as with prior art device 50 within housing 554 there is a first path for the provision of vacuum pressure to a first set of openings 578 between flange 570 and the second set of openings 582. A first cannula 558 connected to a first port 560 may connect the first set of openings 578 to a vacuum source to pull material into housing 554. Note that the first set of openings 578 also has a gap 584.

[0059] One possible advantage of the gaps 584 within the first set of openings 578 and the second set of openings 582 is a decrease in the aggregate area of the first set of openings 578 and the second set of openings 582 so that the velocity of the pressurized fluid and the vacuum pressure are increased compared to a similar partem of openings of the same size without a gap 584. As the device 500 may be rotated along the longitudinal centerline, the location of the gap 584 can be rotated so that all 360 degrees of the body cavity may be exposed to pressurized fluid and vacuum pressure.

[0060] FIG. 8 is a longitudinal cross section of prior art device 500.

[0061] FIG. 9 is an enlarged portion of the longitudinal cross section of prior art device 500 shown in FIG. 7. As best seen in FIG. 9 the second pathway 592 carrying pressurized fluids includes second channel 512, chamber 572 and then out through housing 554 via any of the second set of openings 582.

[0062] As best seen in FIG. 9 the path for material removed from the body cavity is through first pathway 588 is through one of the set of first openings 578 through housing 554 and then through gap 510 separating inner housing 520 from housing 554. The first pathway 588 passes through inner housing 520 via one a third set of openings 524 to annular volume 528 which surrounds isolated second channel 512. Moving proximally, the annular space for vacuum flow decrease as noted at location 532 and more proximal location 536. The material conveyed by vacuum on the first pathway 588 leaves device 504 through first port 560. [0063] Prototype Device.

[0064] FIG. 10 shows a prototype created to implement the fluid flow properties of the embodiment from the '908 application shown in FIGs. 12-14 of the '908 application. As the replication is substantial but not perfect, the device in FIG. 10 is referred to as device 504 rather than 500.

[0065] Pressurized fluid can travel on second pathway 592 through second cannula 562, second port 564, second channel 512, chamber 572, and out one of the second set of openings 582.

[0066] FIG. 11 provides a perspective view of a cross-section of device 504 taken distal to the flange 570. Visible in this view are housing 554, inner housing 520, first set of openings 578 in housing 554, third set of openings 524 in inner housing 520, second channel 512 for provision of pressurized fluid, and annular volume 528 between the outer wall of second channel 512 and inner wall of inner housing 520. Note that non-liquid material may become stuck in individual openings in the first set of openings 578, third set of openings 524, the gap between the inside of the housing 554 and the outside of the inner housing 520, or in the relatively narrow gap in the annular volume 528 between the outer wall of the second channel 512 and the inner wall of the inner housing 520.

[0067] Table 3 looks at the relative cross sectional areas along the second pathway 592.

[0068] TABLE 3.

Within the second set of openings 582 Total-0.415 Square 0.070 V

(FIG. 10) Inches

[0069] Thus, as pressurized fluid traverses device 504, the velocity of the pressurized fluid varies but ends up only 70% of the inlet velocity. Compare with Table 1 where the velocity of fluid leaving the set of four fluid ports 134 is more than 4x the velocity of the pressurized fluid entering device 100.

[0070] Table 4 looks at the velocity of the material drawn from the first set of openings 578 along the first pathway 588.

[0071] TABLE 4.

[0072] Several things stand out when comparing Table 4 examining the vacuum path for device 504 versus Table 2 examining the vacuum path for device 100. First the variation between the total volume of vacuum ports and the vacuum line is much smaller in device 100 than in device 504. The large disparity in cross sectional area means that the vacuum suction pulling material into device 504 would be much smaller than the vacuum suction pulling material into device 100 if both were connected to the same vacuum source.

[0073] Second, the cross sectional area of the vacuum path leaving device 100 at 0.078 square inches is approximately 2.7 times the cross sectional area of the vacuum path leaving device 504 at 0.029 inches square. For a device intended to remove a range of materials from a body cavity including non-liquid items, having a larger minimum size is an advantage.

[0074] Third, the sequence of cross-sectional areas in Table 4 has a local maximum at the annular volume 528 which is significantly smaller than before or after the annular volume 528. Dramatic changes in cross-sectional area and thus velocity are apt to cause material to drop out from the outbound flow when the velocity slows.

[0075] In marked contrast, the cross-sectional area in device 100 as reflected in Table 2 is consistently getting smaller although the cross-sectional area at exit is still 2.7 times the area at exit from device 504. Further, the large cross sectional area of the individual vacuum ports 144 from device 100 are well suited to allow non-fluid items to enter the device 100 and there is not a second set of openings in a second housing to impede the movement of non-liquid items.

[0076] Test of Device 504 against Device 700 (Early Version of Device 100).

[0077] In order to get an initial assessment of the performance of device 100 against a benchmark of device 504, an artificial GI tract was created using 1.25 ID silicone tubing. In lieu of using fecal matter for the testing, a soybean paste was included in the faux body cavity. The formula for the soybean paste used as a fecal simulant is as follows.

[0078] Materials to make about 2/3rds of a pound of simulant are:

· 120 grams of dry mix comprised of 50% isolated soy protein with less than 2% lecithin, 30% rice flour, and 20% salt.

• 159 grams of water.

• 43 grams of canola oil.

[0079] The simulant is created by:

· Add the dry mix to the mixer and turn on the mixer.

• Slowly add water and oil in even increments until the dough is soft, slightly sticky, and retains its shape (10 minutes).

• Continue to mix for 2 minutes to even out the dough.

• Take a palm-sized piece and roll into a log. The log should stretch slightly before breaking in extension. The log should bend slightly and break in shear. • To store, wrap in plastic wrap and leave at room temperature. Refrigeration is recommended for storage longer than 24 hours. Shelf life is approximately one week.

[0080] Test Procedure

[0081] Materials and Equipment.

• 1-1/4 silicon tubing (McMaster-Carr 5155T69), 15 inches

• Cable ties, (McMaster-Carr 7130K12), 6 each

• Bump Tubing (Qosina#), 8ft,

• Vacuum pump (Medi-Pump 2107CA20P-721 or equivalent)

• 1 inch PVC tubing, 6 inches

• 1 inch PVC reducing coupling

• ½ inch barbed fitting (McMaster-Carr 5372K125)

• Oatey All Purpose Cement for PVC

• Standard Enema kit

• Stopcock

• Simulation Feces (per recipe listed above)

• Prototype device (100 or 504)

[0082] Procedure.

• Fit PVC tubing and fittings together with the reducing coupling and barbed fitting on one end. Use the PVC cement to bind the pipe and fitting together.

• Slide the silicone tube over the opposite end of the PVC pipe up to the coupling.

• Slide a 3 ft. section of bump tubing onto the barbed fitting and hang the end up as vertical as possible.

• Fold over the end of the open end of the silicone tubing and use a cable tie to cinch down the folded opening to roughly the size of the prototype diameter.

• Use another cable tie to tie cinch the silicone tubing 6 inches from the open end.

• Assemble the enema kit according to the instructions. Hang from the top of the workbench • (~ 3 feet).

• Slide the Roberts clamp onto the end of a ¼ inch x 4 ft. long hose.

• Close the Roberts camp.

• Attach the hose to the appropriate barb on the cleaning device.

• Attach a hose (1/4 or 3/8 inch) onto the remaining barb of the cleaning device.

• Connect the hose from (7) to the "Patient" side of the vacuum pump.

• Close the valve in-line (8).

• Fill the enema bag with 1.5L of DI water.

• Load the simulation feces into the open end of the silicone tubing up to the 2 ^nd cable tie, leaving 1 inch of clearance from the open end of the silicone tubing. With this setup and recipe, -1/4 lb. of simulation feces is loaded into the silicone tubing. It is best to finish the setup and run the test as soon as this step is completed.

• Plug in and power on the vacuum pump.

• Adjust the pressure on the vacuum pump to -22 mm Hg.

• Open the Roberts clamp on the enema bag line (4).

• Open the valve in-line with the vacuum pump (9).

• Insert the cleaning device into the simulated colon slowly.

• Once the cleaning device is inserted far enough to just cover the vacuum holes, cease insertion, and wait for the water to dilute the waste (~1L of water drained).

• Slowly insert and retract the cleaning the device using the following:

o Linear Motion

o Rotational Motion

o Circular Motion

• Scrape the walls of the simulated colon with the side of the cleaning device in a circular motion.

• Continue until no particulate is drained from the simulated colon.

• Rinse all parts out and reset from Step (1). [0083] Testing of Device 504 and Device 700.

• Rectal model created using 1 ¼" ID silicone tubing as noted above

• Zip ties used to simulate anatomical geometry and strictures.

• 80g Custom made soybean paste used as fecal simulant (recipe in Appendix) for each test run.

• Two Liter saline reservoir (water used instead of saline).

• Head height of saline reservoir to be 36 inches.

• Vacuum pressure set at 22mm Hg.

[0084] Results and Observations for Test of Device 504.

• Due to the design of the outer shaft, the prototype 504 has to be inserted into the rectal model roughly 3.5 inches before the vacuum ports are actually engaged. Prior to this depth of insertion, the distal vacuum ports are not sucking in any water as the proximal vacuum ports are allowing air to bypass the system.

• As a result, we noticed a substantial amount of solid matter being pushed distally into the rectal model. The volume of solid matter, pushed distally is roughly equal to the volume of the prototype device 504 distal shaft.

• During the time it took to insert the prototype into the rectal model to the appropriate depth, we noticed substantial leakage out the proximal end of the rectal model. This is a result of the vacuum ports not being fully engaged.

• Once we had inserted the prototype to the full depth we used a combination of motions to clear the solid matter.

o Rotation along axis of device

o Linear, in and out of the rectal model

o Circular

• After roughly two minutes we had cleared the solid contents of the first five inches of the rectal model. This is the length of the prototype device 504 handle.

• The solid matter that was initially pushed distally, during insertion of the prototype was not able to be retrieved as it was beyond the reach of the prototype device 504. • Of the 80g of starting solid material, we were able to retrieve 46g, leaving 34g of solid material in the distal section of the rectal model.

• Of the 46g of solid matter that was removed, roughly 5-10g of solids remained in the prototype.

• Total volume of water used to remove the 46g of solid material was 1.5 liters.

• It is important to note that our rectal model is not an anatomically correct model in that it does not truly represent the geometry or behavior of the human rectum and colon.

• Summary: two min, 46g solid matter removed, 34g solid matter remained, 1.5 liters of water.

[0085] Explanation of Difference between Device 100 and Device 700.

[0086] FIG. 12 is the cross section of device 100 previously shown in FIG. 4 but with fewer element numbers to minimize clutter. FIG. 13 is a cross section of an earlier version of this device. As this earlier device is slightly different from the device 100, it is device 700.

[0087] Device 100 differs from device 700 in the path taken for fluid supply tube 130. In device 100, the fluid supply tube 130 is run along the midline of the device 700. In device 100, a portion of the path of fluid supply tube 130 is along the upper interior wall of device 100. This is the only difference between the two devices. The discussion of velocity caused by changes in square area apply equally to both device 100 and device 700 so it is believed that test results for device 700 are indicative of the performance of device 100.

[0088] Results and Observations for Test of Device 700.

• Wet Lab Testing recorded on video.

• As shown in the video we noticed a substantial increase in flow velocity as saline exited the distal tip of the prototype.

• There was a minor amount of clear fluid that leaked out of the rectal model upon insertion of the device.

• As the device was inserted further to engage the vacuum ports, solid matter was partially extruded into the vacuum ports. (Note, this did not clog the vacuum ports). • As a result, very little solid matter was pushed distally as the device was inserted.

• As soon as the vacuum ports engaged, the solid matter was mined away by moving the device in a gentle circular motion.

• Material was removed as the device was slowly pushed distally.

• No leakage was observed during the removal of solid matter.

• After roughly one minute we had cleared the solid contents of the entire rectal model.

• The small amount of solid matter that was initially pushed distally, during insertion of the prototype was suctioned back into the prototype.

• Of the 80g of starting solid material, we were able to retrieve 80g.

• Roughly 5g of solid material remained inside the prototype.

• Total volume of water used to remove the 80g of solid material was 1.25 liters.

• It is important to note that our rectal model is not an anatomically correct model in that it does not truly represent the geometry or behavior of the human rectum and colon.

• Summary: one min, 80g solid matter removed, no solid matter remained, 1.25 liters of water.

[0089] Summary of the Testing.

[0090] For the test of device 504 and device 700, the following parameters were kept constant:

• 80 grams of the soybean paste were inserted into the faux body cavity,

• water was used instead of saline,

• the water was held in a reservoir to provide 36 inches of head from the initial height of the fluid reservoir;

• Vacuum pressure at the source was set at 22 millimeters of mercury. [0091] Results are summarized in Table 5.

[0092] TABLE 5.

[0093] Comments from Testing.

[0094] When using device 504, there was no effective removal of material until the most proximal of all of the first set of openings 578 were inserted into the body cavity. With the design of the device 504, this meant that the device 504 needed to be inserted 3.5 inches. During the insertion of the first 3.5 inches of device 504, the soy paste in the body cavity was pushed distally and the pressurized fluid was leaking out the proximal end of the body cavity as there was not effective removal by vacuum and the flange was not close to the proximal end of the body cavity.

[0095] The distal shaft diameter of the device 100 was a bit smaller than the distal shaft diameter of the device 504. The difference is approximately 1/8* of an inch but this difference is believe to make the insertion of a device into a rectum to easier for the medical provider and less traumatic to the patient's anatomy.

[0096] Clinical Impact.

[0097] Changes from a device like device 504 to a device like device 700 or device 100 will reduce the time necessary to remove material from a body cavity. A few minutes saved when setting up and cleaning a rectum before an endoscopic or surgical procedure reduces the time that the surgical team and the operating room are used. The surgical team and the operating rooms are expensive resources so saving time is saving money. [0098] Reducing the amount of leakage through having effective vacuum operation early in the insertion process leads to less need for cleaning of the surgical table or the patient and is more pleasant for the surgical team.

[0099] A more effective process to clear out the rectum with less risk of pushing fecal matter out of reach of the device may lead to a better view of the cavity during subsequent steps and thus better diagnostic accuracy.

[00100] Third Port.

[00101] One prior art surgical procedure is a surgical anastomosis. A surgical anastomosis is a surgical technique used to make a new connection made between two body structures that carry fluid, such as blood vessels or bowel. For example, an arterial anastomosis is used in vascular bypass and a colonic anastomosis is used to restore colonic continuity after the resection of colon cancer. A surgical anastomosis can be created using suture sewn by hand, mechanical staplers and biological glues, depending on the circumstances. https://en.wikipedia.org/wiki/Surgical_anastomosis

[00102] In some fraction of surgical procedures the connection of two segments of the gastrointestinal tract is not complete so that there is a path for contents of the GI tract to leak out into the body cavity. This is a serious and potentially life threatening complication.

[00103] An introduction to one recent article on this subject started as follows:

Colorectal anastomotic leakage (CAL) still remains a frequent and dangerous complication after gastrointestinal surgery, occurring in 4%-33% of patients and contributing to one third of postoperative mortality. An anastomotic defect causes leakage of colonic content into the abdominal or pelvic cavity leading to peritonitis, abscess formation or sepsis. CAL substantially prolongs hospital stay - by one to two weeks - and increases medical costs by as much as $24000 within the first period of hospitalization, thereby approximately tripling the expenditure relative to that of normal recovery. Moreover, CAL is identified as a risk factor for local recurrence of colorectal cancer and is reported to reduce long-term cancer specific survival. The need for more effective strategies to prevent and detect CAL is undoubtedly urgent. [00104] See - Integrated Approach to Colorectal Anastomotic Leakage: Communication, Infection and Healing Disturbances, Sparrebroom, Cloe L, et al. World J. Gastroenteral 2016 August 28: 22(32): 7226-7235. [00105] Device 100 may be modified to add a third port.

[00106] FIG. 14 shows device 300 which is device 100 with the addition of a third port such as needleless injection port 304. The port may be comparable to Qosina 80146 Needleless Y Swabbable Injection site, as shown at www. Qosina.com/needleless-y- injection-site-swabbable-80146 (space added to avoid a live link). While a needless port is preferred, the third port could employ a connection that would allow introduction of a therapeutic fluid through a needle.

[00107] This third port such as needleless injection port 304 may be used for a variety of purposes. One purpose for third port such as needleless injection port 304 is the introduction of a therapeutic liquid such as an antibiotic into the body cavity. The body cavity may have received treatments to remove undesired growths or damaged tissue. The remaining tissue after the surgical procedure may benefit from the localized application of antibiotics or some other therapeutic liquid directly to the body cavity rather than through a systemic dosing. After turning off the source of pressurized liquid to the first port and the source of vacuum to the second port, the therapeutic liquid can be introduced through the third port.

[00108] The uses of the third port to deliver a therapeutic liquid may vary based on the preferences of the surgeon and the particular medical needs of the patient. In some instances, an antibiotic such as Flagyl® or Cipro® may be sprayed over some or all of the body cavity within reach of the inserted device. In most instances, the expensive antibiotics or other therapeutic liquid would be applied at the end of the procedure and not vacuumed out of the body cavity.

[00109] Another purpose for the third port such as needleless injection port 304 is to allow the introduction of air or some other gas such as C02 in order to assess the body cavity for leakage. An inflation bulb with valve that may be used to inject air through the third port such as needleless injection port 304 in order to check for leakage from the body cavity. For example open surgery or laparoscopic surgery on the colon may merit leak testing after completion of the surgery which may include constricting the GI track above the location to be leak tested. The duration of the leak test may be in the range of 10 to 20 seconds after application of the desired pressure

[00110] Note that the inclusion of a third port could be done to earlier prior art devices such as the devices shown in United States Provisional Patent Application No. 62/517,827 filed June 09, 2017 for Device for Cleaning Proximal Portion of Body Cavity.

[00111] Method of Use.

[00112] FIG. 15 provides a flow chart for method 1000 for a process of removing material from a body cavity.

[00113] Step 1004 Obtain a device for insertion into a body cavity, the device having a first flow path to provide fluid to the body cavity through a first set of openings near a distal end of the device. The first set of openings in fluid communication with a source of fluid for injection into the body cavity. The area of the inlet for the device for fluid for injection into the body cavity being larger than the total area of the first set of openings near a distal end of the device so that the velocity of fluid ingressing into the device is less than the velocity of the fluid egressing the device. The device having a second set of openings in fluid communication with a vacuum source so that material can be removed from the body cavity. The total of area of the second set of openings being more than the area at the egress of the device so that the velocity of the material increases from ingress to egress.

[00114] Step 1008 Insert the distal tip of the device into the body cavity until both the first set of openings and the second set of openings are inserted into the body cavity. A lubricant may be applied to the distal portion of the device before insertion. The source of fluid may be actuated to provide irrigation before insertion into the body cavity or just after insertion into the body cavity. The vacuum source may be actuated at about the same time the source of irrigation fluid is activated.

[00115] Step 1012 Using a combination of linear motion - in and out of the cavity and rotation of the device around the longitudinal axis of the device to expose portions of the body cavity to the fluid source and the vacuum source in order to remove material from the body cavity. [00116] Step 1016 Optionally, spraying a therapeutic fluid into the body cavity through a first set of openings near a distal end of the device. The injection of a therapeutic fluid would occur after removal of the material to be removed. The fluid source would be shut off so avoid diluting the therapeutic liquid and the vacuum source would be shut off so that the therapeutic liquid remains in the body cavity.

[00117] Step 1020 Optionally, after using the device to clear the cavity of material that can be removed by a combination of the fluid and the vacuum, using the device to add a gas (such as ambient air) to the body cavity to see if the body cavity resists additional addition of gas to confirm that the body cavity lacks any opening that would allow the added gas to escape rather than pressurize the cavity. The optional testing of the body cavity occurring after stopping the supply of pressurized fluid but closing a line between the device and the source of pressurized fluid and stopping the provision of vacuum to the device by closing a line between the device and the source of vacuum. [00118] Suitable Materials.

[00119] The body of device 100 may be made of material suitable for contact with body cavity tissues. While not required, it can be helpful to make the device and associated tubing transparent so that the clinical team can know that the device is not clogged and is continuing to remove material.

[00120] ALTERNATIVES AND VARIATIONS

[00121] Source of Pressurized Fluids.

[00122] One of skill in the art may elect to provide pressurized fluids for irrigation and removal of material from the body cavity through the use of a pump and a pressure regulating device to avoid inadvertent introduction of pressurized fluid into a body cavity at a pressure or velocity that might impart damage on body tissues. An alternative is to provide the pressurized fluid from a reservoir of fluid in fluid communication with the device where the fluid reservoir is held elevated relative to the elevation of the body cavity so that the difference in elevation is a controlled pressure source that is does not rely on the operation of controls to limit the pressure supplied to the device. [00123] Testing of prototype devices found that having a reservoir of fluid 36 inches above the opening to the body cavity was sufficient to provide adequate irrigation.

[00124] Number of Ports.

[00125] The example device 100 showed a set of four vacuum ports 144 and four fluid ports 134 equally spaced around the circumference of device 100. While this configuration is a good choice, those of skill in the art will appreciate that a single vacuum port and fluid port may be used as the device may be rotated around the long axis to provide coverage within the body cavity.

[00126] A device may be made with a different number of fluid ports 134 than vacuum ports 144. A device may be made with two, three, and even five evenly spaced vacuum ports. Having more than five vacuum ports may lead to vacuum ports that are relatively small and that may be appropriate for some applications but perhaps not for cleaning the lower GI tract.

[00127] Laparoscopic Surgery.

[00128] Laparoscopic surgery and other forms of minimally invasive surgery have surgical sites created within the body which are accessed by a surgical access channel. This forms a body cavity for the performance of a surgical procedure or other therapy. Those of skill in the art know that there is a wide range of surgical procedures performed via minimally invasive surgical procedures. In many instances, there is a need to irrigate and remove blood or other material from the surgical site. A modified version of the devices 100 or 300 could be sized for insertion through a trocar into the surgical site. The trocar may be a 5mm trocar, a 10mm trocar or another trocar of appropriate size for the surgical procedure. A device for use with laparoscopic surgery may not benefit from a flange to preclude over insertion into the body cavity and thus a device adopted for use in laparoscopic surgery may not have a flange.

[00129] One of skill in the art will recognize that some of the alternative implementations set forth above are not universally mutually exclusive and that in some cases additional implementations can be created that employ aspects of two or more of the variations described above. Likewise, the present disclosure is not limited to the specific examples or particular embodiments provided to promote understanding of the various teachings of the present disclosure. Moreover, the scope of the claims which follow covers the range of variations, modifications, and substitutes for the components described herein as would be known to those of skill in the art.

[00130] The legal limitations of the scope of the claimed invention are set forth in the claims that follow and extend to cover their legal equivalents. Those unfamiliar with the legal tests for equivalency should consult a person registered to practice before the patent authority which granted this patent such as the United States Patent and Trademark Office or its counterpart.