Abstract:
A medical device is provided for use in the lumen of a patient, such as in the Gastro-Intestinal Tract (GI Tract). The medical device can include a through channel for permitting passage of solid material, such as fecal material in the GI tract. In one embodiment, the device includes a self propelled capsule with a through channel, and a balloon disposed inside of the channel of the capsule. When inflated, the balloon provides occlusion of the channel.

Description:
[0001]    This application claims priority to the following provisional patent applications: “Method for Providing Access to Luminal Tissue”, Serial No. 60/344,426, filed Nov. 9, 2001 in the name of Long et al.; and “Luminal Propulsive Device Having a Generally Continuous Passageway”, Serial No. 60/344,429, filed Nov. 9, 2001 in the name of Long et al. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    The present invention relates to a medical device that moves within a lumen of a patient&#39;s body.  
         BACKGROUND  
         [0003]    A physician typically accesses and visualizes tissue within a patient&#39;s gastrointestinal (GI) tract with a long, flexible endoscope. For the upper GI, a physician may insert a gastroscope into the sedated patient&#39;s mouth to examine and treat tissue in the esophagus, stomach, and proximal duodenum. For the lower GI, a physician may insert a colonoscope through the sedated patient&#39;s anus to examine the rectum and colon. Some endoscopes have a working channel, typically about 2.5-3.5 mm in diameter, extending from a port in the handpiece to the distal tip of the flexible shaft. A physician may insert medical instruments into the working channel to help diagnose or treat tissues within the patient. Physicians commonly take tissue biopsies from the mucosal lining of the GI tract using a flexible, biopsy forceps through the working channel of the endoscope.  
           [0004]    Insertion of a flexible endoscope, especially into the colon, is usually a very time-consuming and uncomfortable procedure for the patient, even when sedated with drugs. A physician often needs several minutes to push a flexible endoscope through the convoluted sigmoid, descending, transverse, and ascending portions of the colon. The physician may diagnose and/or treat tissues within the colon either during insertion or removal of the endoscope. Often the flexible endoscope “loops” within the colon, such as at the sigmoid colon or at the splenic flexure of the colon, so that the inserted length of the endoscope is longer than the portion of colon containing it. Depending on the anatomy of the patient and the skill of the physician in manipulating the flexible endoscope, some portions of the colon may be unexamined, thus increasing the risk of undiagnosed disease.  
           [0005]    Given® Engineering LTD, Yoqneam, Israel, sells a device in the U.S. called the M2A™ Swallowable Imaging Capsule. The device contains a tiny video camera, battery, and transmitter. It is propelled through the gastrointestinal tract by natural peristalsis. The device is currently used for diagnostic purposes and passes through the intestinal tract with a velocity determined by the natural, peristaltic action of the patient&#39;s body. World Publication WO 0108548A1 filed by C. Mosse, et al. describes a self-propelling device adapted to travel through a passage having walls containing contractile tissue. The applicants disclose that the device is particularly useful as an enteroscope and may also carry objects such as feeding tubes, guide wires, physiological sensors or conventional endoscopes within the gut. A summary of other alternatives to push endoscopy can be found in “Technical Advances and Experimental Devices for Enteroscopy” by C. Mosse, et al, published in Gastrointestinal Endoscopy Clinics of North America, Volume 9, Number 1, January 1999: pp. 145-161.  
           [0006]    Often during colonoscopy, the physician finds that the patient has been inadequately prepared for the procedure, and a large amount of feces and other matter may be obstructing the passage of a flexible endoscope into the colon. A device and method for either proceeding with the examination or for cleaning the colon immediately prior to the examination would save overall time and costs for both the physician and the patient. What is needed, therefore, is a self-propelled, intraluminal device that includes means for using the device in a lumen containing obstructive matter such as feces, or for thoroughly cleaning such matter from the lumen prior to endoscopic examination.  
         SUMMARY OF THE INVENTION  
         [0007]    In one embodiment, the present invention provides an apparatus, such as a capsule, adapted for movement through a bodily lumen, such as the gastro-intestinal (GI) tract. The apparatus comprises a channel passing longitudinally through the apparatus. The through channel is sized and shaped to pass solid material, such as fecal material in the GI tract. The device can include an inflatable member for occluding the through channel so that the solid material can be withdrawn from the lumen when the apparatus is removed from the body. The apparatus can include one or more electrodes for providing electrical stimulation of lumen tissue for moving the apparatus through the lumen. The apparatus can further include a recess in its outer surface, and one or more seals for separating lumen tissue positioned at the recess from adjacent portions of the lumen.  
           [0008]    The present invention can also provide a method for removing solid material, such as fecal material, from a lumen. By way of example, the method can be used as part of a bowel preparation procedure prior to a subsequent surgical or other medical procedure. In one embodiment, the method includes the steps of moving an apparatus sized and shaped to pass through the GI tract, such as by electrical stimulation of GI tissue, expanding a portion of the apparatus, such as by inflation, and withdrawing the apparatus from GI tract to remove the material from the GI tract. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0009]    We have set forth the novel features of the invention with particularity in the appended claims. To fully understand the invention, however, please refer to the following description and accompanying drawings.  
         [0010]    [0010]FIG. 1 is a cross sectional view of a wall  14  of a hollow organ such as the colon.  
         [0011]    [0011]FIG. 2 is a perspective view of a medical device  101  of the present invention, including an end view and a side view of a capsule  100 , side views of an umbilicus  140 , a valve  42 , and an inflater  40 , and a schematic view of a control unit  20 .  
         [0012]    [0012]FIG. 3 is a sectional view of capsule  100  shown in FIG. 2 positioned inside of a bodily lumen  15 , wherein capsule  100  includes a channel  102  for passage of solid matter  16 .  
         [0013]    [0013]FIG. 4 is a sectional view of capsule  100  shown in FIG. 2 positioned inside of a bodily lumen  15 , wherein a balloon  108  is shown in an inflated configuration and occluding channel  102  to prevent the passage of solid matter  16 .  
         [0014]    [0014]FIG. 5 is an end view of a capsule  200 , which includes a plurality of distal electrodes  212  and a channel  202 .  
         [0015]    [0015]FIG. 6 is a side view of capsule  200  shown in FIG. 5, and also including a plurality of proximal electrodes  210 .  
         [0016]    [0016]FIG. 7 is a sectional view of capsule  200  shown in FIG. 6, showing an umbilicus  240  attached to the inside of channel  202 , and including a balloon  208  shown in a deflated configuration.  
         [0017]    [0017]FIG. 8 is an end view of a capsule  300 , which includes a plurality of distal electrodes  312  and a channel  302 , wherein distal electrodes  312  are flexibly mounted.  
         [0018]    [0018]FIG. 9 is a side view of capsule  300  shown in FIG. 8, and also including a plurality of distal electrodes  310 , wherein proximal electrodes  310  are flexibly mounted.  
         [0019]    [0019]FIG. 10 is a sectional view of capsule  300  shown in FIG. 9, showing an umbilicus  340  attached to the inside of channel  302  and including a balloon  308  shown in a deflated configuration.  
         [0020]    [0020]FIG. 11 is an end view of a capsule  400 , which includes a leading end  404  having a plurality of struts  403  spanning a channel  402 .  
         [0021]    [0021]FIG. 12 is a side view of capsule  400  shown in FIG. 11, showing leading end  404  and a trailing end  406  separated by an expandable body  405 , and an umbilicus  440  attached to trailing end  406 .  
         [0022]    [0022]FIG. 13 is a sectional view of capsule  400  of FIG. 12, showing a conduit  416  longitudinally positioned inside of channel  402  and connecting trailing end  406  to leading ends  404 , and a balloon  408  shown in a deflated configuration and mounted on conduit  416 .  
         [0023]    [0023]FIG. 14 is a side view of capsule  400  of FIG. 13 positioned inside of bodily lumen  15  and in a contracted configuration, thus allowing passage of solid matter  16  as capsule  400  moves in a forward (left) direction.  
         [0024]    [0024]FIG. 15 is a sectional view of capsule  400  of FIG. 14 positioned inside of bodily lumen  15  and in an expanded configuration, wherein balloon  408  is shown in an inflated configuration, thus occluding channel  408 , so that the operator may pull an umbilicus  440  to remove solid matter  16  from bodily lumen  15 .  
         [0025]    [0025]FIG. 16 is schematic view of a medical device  501 , another embodiment of the present invention, and includes the same elements as medical device  101  of FIG. 1, but also includes a fluid source  32 , a vacuum source  30 , a fluid valve  34 , and a fluid line  36 .  
         [0026]    [0026]FIG. 17 is a perspective view of a capsule  500 , which includes a recess  515  with a port  517 , a plurality of distal electrodes  512 , a plurality of proximal electrodes  510 , and an umbilicus  540 .  
         [0027]    [0027]FIG. 18 is a perspective view of a capsule  600 , which includes a recess  615  with a port  617 , a plurality of distal electrodes  612  flexibly mounted, a plurality of proximal electrodes  610  flexibly mounted, and an umbilicus  640 .  
         [0028]    [0028]FIG. 19 is a sectional view of capsule  500  of FIG. 17, shown in a non-sealing configuration while recess  515  is positioned over a tissue structure  13  inside of a working space  516 .  
         [0029]    [0029]FIG. 20 is a sectional view of capsule  500  of FIG. 19, shown in a sealing configuration while working space  516  is filled with a fluidic agent  31 .  
         [0030]    [0030]FIG. 21 is a sectional view of capsule  500  of FIG. 20, shown as a medical device  580  may be used inside of working space  516 .  
         [0031]    [0031]FIG. 22 is an exploded, perspective view of capsule  500  of FIG. 17, an endoscope adapter  600 , and an endoscope  680 . 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0032]    The present invention is a self-propelled intraluminal medical device including one or more of the improvements previously listed. By way of example, the present invention is illustrated and described for application in the colon of a human patient. However, the present invention is applicable for use in the bodily lumens of other hollow organs in humans and in other mammals.  
         [0033]    [0033]FIG. 1 shows a section of a wall  14  of the mammalian colon, and includes a mucosal layer  2 , a submucosal layer  4  (shown with a lymph node  12 ), a circular muscular layer  6 , a longitudinal muscular layer  8 , and a serosa  10 . Natural peristalsis is a progressive wavelike contraction of wall  14  that occurs involuntarily and is normally stimulated by distention of wall  14  from the contents within. Circular muscular layer  6  and longitudinal muscular layer  8  comprise the contractile tissue and contract when electrically stimulated, causing an instantaneous circumferential reduction of that portion of the lumen.  
         [0034]    [0034]FIG. 2 illustrates a medical device  101  of the present invention and comprises a capsule  100 , an umbilicus  140 , a control unit  20 , an inflater  40 , and a valve  42 . Capsule  100  has a leading end  104 , a trailing end  106 , and is sized to slide easily through the anus of the patient. In general, the outside of capsule  100  is smooth and streamlined for sliding easily through the colon. Trailing end  106  of capsule  100  is tapered so that when the colon constricts due to electrical stimulation, capsule  100  moves in a forward direction with attached umbilicus  140  trailing behind. Many other suitable shapes for capsule  100  are possible. Umbilicus  140  is flexible and is approximately as long as the flexible shaft of a colonoscope, which typically has a length of about 1.7 meters. Umbilicus  140  is preferably made from a thin wall flexible plastic or rubber tube suitable for transporting fluid between inflater  40  and capsule  100 . Capsule  100  further includes a plurality of electrodes  110  that are mounted on trailing end  106  and electrically connected to control unit  20 .  
         [0035]    Control unit  20  provides electrical pulses to electrodes  110 . At least one of electrodes  110  receives electrical pulses of a first electrical polarity, and the remaining electrodes receive electrical pulses of a second (opposite) electrical polarity. Control unit  20  comprises a frequency generator that provides at least one electrical waveform. Suitable waveforms include sinusoidal waves, square waves, triangular waves, and combinations. Control unit  20  also includes a constant current source, such as the Stimulus Isolator commercially available from World Precision Instruments of Sarasota, Fla. Control unit  20  allows the operator to activate and deactivate electrical stimulation to the colon, thus controlling the intraluminal propulsion of capsule  100 . Control unit  20  also allows the operator to control the electrical pulse frequency of the stimulation, which may be generally uniform or varying. A suitable pulse frequency is approximately in the range of 5 to 20 Hz, but can be as high as approximately 1000 Hz. Control unit  20  also allows the operator to control electrical stimulation current amplitude. A suitable electrical stimulation current amplitude is approximately in the range of 10 to 50-mA, but can be as high as about 100-mA. However, it is also possible for waveform, frequency, and current amplitude to operate according to predetermined values set in control unit  20 , therefore not requiring operator adjustment during the medical procedure. One particularly suitable electrical stimulation type is a half duty cycle, 15 Hz, 30-mA square wave.  
         [0036]    [0036]FIG. 3 and FIG. 4 are sectional views of capsule  100  while positioned inside of a bodily lumen  15 , which is the lumen of the colon in this example. Capsule  100  can include a through channel  102 . Through channel  102  can be sized and shaped to be able to pass solid material, such as fecal material, through the capsule  100 . The channel  102  can have a generally cylindrical shape (generally circular when viewed on end, as in FIG. 5), though other shapes may be suitable. The channel  102  can have a maximum radial dimension (such as when viewed as in FIG. 5) which is at least about one-half the maximum radial dimension of the capsule  100  (e.g. channel  102  can have diameter which is at least about half the maximum diameter of the capsule  100 ); more particularly, the channel  102  can have a maximum radial dimension which is at least about two-thirds the maximum radial dimension of the capsule  100 . By way of example, the channel  102  can have a diameter of at least about one half inch; more particularly the channel  102  can have a diameter of at least about three quarters of an inch.  
         [0037]    In FIG. 3, solid matter  16  passes through a channel  102  of capsule  100  as capsule  100  and umbilicus  140  move in a forward (left) direction. A balloon  108  mounted on the distal end of umbilicus  140  inside of channel  102  is shown in a deflated configuration, thus allowing passage of solid matter  16  through capsule  100 . Electrodes  110  contact wall  14  of the colon as electrical pulses from control unit  20  (FIG. 2) electrically stimulate the contractile tissue in wall  14 . The portion of wall  14  that surrounds trailing end  106  of capsule  100  constricts, and capsule  100  “selfpropels” in the forward direction, which for this example, is against the natural, peristaltic direction. In FIG. 4, balloon  108  is shown in the inflated configuration, thus occluding channel  102  and preventing passage of solid matter  16  through capsule  100 . While control unit  20  is deactivated, the operator may pull gently on umbilicus  140  to move capsule  100  in a reverse (right) direction, while at the same time removing solid matter  16  that is on the proximal side of capsule  100 . As capsule  100  is pulled towards the anus, solid matter  100  and accompanying fluids may then be collected in an appropriate receptacle external to the patient. The bowel preparation is then completed, and the physician may next proceed with a conventional colonoscopy using a flexible endoscope to examine the interior walls of the colon.  
         [0038]    [0038]FIG. 5 is an end view and FIG. 6 is side view of a capsule  200 , which comprises a leading end  204  having a plurality of distal electrodes  212 , and a trailing end  206  having a plurality of proximal electrodes  210 . Capsule  200  may be used instead of capsule  100  as part of medical device  101  shown in FIG. 2. Distal electrodes  212  electrically connect to control unit  20  with a pair of wires  219 . Proximal electrodes  210  electrically connect to control unit  20  with a pair of wires  220 . When control unit  20  sends electrical pulses to proximal electrodes  210 , capsule  200  moves in the forward direction. When control unit  20  sends electrical pulses to distal electrodes  212 , capsule  200  moves in the reverse direction. When control unit  20  sends electrical pulses to both distal electrodes  212  and proximal electrodes  210 , capsule  200  is held tightly in place by the constriction of colon around trailing end  206  and leading end  204 .  
         [0039]    [0039]FIG. 7 is a sectional view of capsule  200  of FIG. 6. The distal portion of umbilicus  240  attaches to capsule  200  with a clip  226  located in a recess  224 . A balloon  208 , shown in a deflated configuration, is mounted on the distal portion of umbilicus  240  and is fluidly connected to inflater  40  (FIG. 2). When balloon  208  is in the deflated configuration, solid matter  16  may pass through capsule  200 . When balloon  208  is in the inflated configuration, channel  202  is occluded and solid matter  16  cannot pass through capsule  200 . Wires  219  and  220  exit umbilicus  240  through a seal  222 .  
         [0040]    [0040]FIG. 8 is an end view and FIG. 9 is a side view of a capsule  300  that is generally the same as capsule  200  of FIG. 7, except that distal electrodes  312  are flexibly mounted on a leading end  304 , and also except that proximal electrodes  310  are flexibly mounted on a trailing end  306 . Each of distal electrodes  312  and proximal electrodes  310  are made from a spring metal flat that is formed into one of many possible shapes to allow deflection in the radial direction, thus providing intimate contact with bodily lumen walls of varying diameters to ensure optimal electrical stimulation. A pair of wires  319  electrically connect to distal electrodes  312 , and a pair of wires  320  electrically connect to proximal electrodes  310 . Control unit  20  provides electrical pulses in a similar manner as was describe for capsule  200  of FIG. 7. FIG. 10 is a sectional view of capsule  300 . A balloon  308  is attached to the distal end of umbilicus  340  and is fluidly connected to inflater  40  (FIG. 2). The operator may occlude channel  302  and use capsule  300  for bowel preparation in a similar manner as was described for capsule  100  shown in FIG. 3 and FIG. 4.  
         [0041]    [0041]FIG. 11 is an end view and FIG. 12 is a side view of a capsule  400 , which may be used in medical device  101  of FIG. 2 instead of capsule  100 . Capsule  400  comprises a leading end  404 , and expandable body portion  405 , and a trailing end  406 , which connects to an umbilicus  440 . A plurality of electrodes  410  are mounted on trailing end  406  and are electrically connected to control unit  20  by wires  420 . Leading end  404  includes a plurality of radial struts  403  that span the distal end of a channel  402 . Trailing end  406  similarly includes a plurality of radial struts  407  that span the proximal end of channel  402 . In the sectional view of capsule  400  in FIG. 13, a conduit  416  is disposed longitudinally in channel  402  and connects the centers of leading end  404  and trailing end  406 . A balloon  408  is mounted around conduit  416  and is fluidly connected to inflater  40  (FIG. 2) via at least one port  409  in conduit  416 . When the operator actuates inflater  40 , balloon  408  inflates, occludes channel  402 , and expands expandable body portion  405 , and capsule  400  is in an expanded configuration. When the operator deflates balloon  408 , channel  402  opens and capsule  400  resumes a contracted configuration. The distal end of umbilicus  440  connects to the proximal end of conduit  416 . A pair of wires  420  run through conduit  416  and electrically connects electrodes  410  to control unit  20 . Leading end  404  and the distal portion of conduit  416  are preferably injection molded as one piece from a rigid plastic such as polycarbonate. Trailing end  406  and the proximal portion of conduit  416  are also preferably injection molded as one piece from a rigid plastic. Expandable body portion  405  is preferably made from a length of rubber tube material and attaches to trailing end  406  and leading end  404  as shown. A plug  417  inserts into the distal end of conduit  416  to allow pressurization of balloon  408 . Plug  417  may be removable to allow the operator to use conduit  416  and umbilicus  440  as a working channel for suction, irrigation, or the introduction of various types of medical instruments from outside the bodily lumen to the interior of the bodily lumen.  
         [0042]    [0042]FIG. 14 and FIG. 15 depict how an operator may use medical device  101  (FIG. 2) with capsule  400  (FIG. 12) for bowel preparation. In FIG. 14 capsule  400  moves inside of bodily lumen  15  as the contractile tissue in wall  14  is electrically stimulated by electrodes  410 . Solid matter  16  passes through capsule  400 , which is in the contracted configuration. A sectional view of capsule  400  is shown inside bodily lumen  15  in FIG. 15 for when balloon  408  is inflated with a fluid such as saline and capsule  400  is in the expanded configuration. The outer diameter of expandable body portion  405  is increased substantially so that as the operator pulls on umbilicus  440 , solid matter  416  on the proximal side of capsule  400  may be cleaned from the bodily lumen. Since umbilicus  440  attaches to the center of trailing end  406 , and since radial struts  407  have a rounded profile, capsule  400  may be less likely to catch on protruding or uneven tissue structures (such as diverticula “pouches” in the colon) inside the bodily lumen than for the previous embodiments. During removal of capsule  400  from the bodily lumen, electrical stimulation may be deactivated, although electrical stimulation during removal would not normally be harmful to the patient, and may even be beneficial.  
         [0043]    [0043]FIG. 16 illustrates another embodiment of the present invention, a medical device  501 , which is very similar to medical device  101  of FIG. 2. Medical device  501  includes a capsule  100 , an umbilicus  140 , an inflater valve  42 , an inflater  40 , and a control unit  20 . Medical device  501 , however, includes the additional elements of a fluid source  32 , a vacuum source  30 , a fluid valve  34 , and a fluid line  36 . The operator may use medical device  501  to administer suction and irrigation from outside the bodily lumen to the inside of the bodily lumen. Fluid source  32  may comprise a fluid such as saline, water, a pharmaceutical agent, a surface anesthetic solution, or a cleaning agent, for example. Medical device  501  may be used with any of the capsule embodiments described herein.  
         [0044]    [0044]FIG. 17 is a perspective view of a capsule  500 , which is very similar to capsule  200  of FIG. 6. Capsule  500  comprises a trailing end  506  with a plurality of proximal electrodes  510 , a leading end  504  with a plurality of distal electrodes  512 , a body portion  505 , and a channel  502  for the passage of solid matter  16  as described for the previous embodiments. An umbilicus  540  attaches to trailing end  506 . Capsule  500  also includes, however, a distal inflatable sealing ring  520 , and a proximal inflatable sealing ring  522 . Sealing rings  520  and  522  are disposed circumferentially around body portion  505 . A recess  515  with a port  517  is positioned between sealing rings  520  and  522  on the outside of body portion  505 . When capsule  500  is inside the bodily lumen, recess  515  creates a sealed working space over a portion of the wall of the bodily lumen. Port  517  provides the operator access to the inside of the working space with medical instruments, fluids, and the like, from outside the bodily lumen.  
         [0045]    [0045]FIG. 18 is a perspective view of capsule  600 , which is very similar to capsule  500  of FIG. 17. Capsule  600  comprises a trailing end  606 , a leading end  604 , a body portion  605 , and a channel  602  for the passage of solid matter  16  as described for the previous embodiments. An umbilicus  640  attaches to trailing end  606 . Capsule  600  also includes a distal inflatable sealing ring  620 , a proximal inflatable sealing ring  622 , a recess  615 , and a port  617 , as was described for capsule  500 . Capsule  600  includes a plurality of proximal electrodes  610  and a plurality of distal electrodes  612  that comprise bare metal wire loops flexibly mounted on capsule  600  to improve electrical contact with the wall of the bodily lumen.  
         [0046]    [0046]FIG. 19, FIG. 20, and FIG. 21 are sectional views of capsule  500  inside bodily lumen  15 , and depict how an operator may use capsule  500  to treat a tissue structure  13  on wall  14 . The operator advances capsule  500  within bodily lumen  15  using electrical stimulation as previously described until recess  515  is over the portion of wall  14  to be treated, creating a working space  516  over tissue structure  13 , which may be a polyp, for example. The operator may rotate capsule  500  about the longitudinal axis by manually twisting umbilicus  540 , to center tissue structure  13  inside working space  516 . Visualization inside of working space  516  may be accomplished by numerous ways. For example, a very small diameter fiber optic visualization device (not shown) may be introduced through umbilicus  540  and port  517  to position recess  517  over tissue structure  13 , then removed so that port  517  may be used for administering fluids, agents, and the like. It is possible also to install a small camera (CMOS, CCD) that is electrically connected to a display and signal processing unit (not shown) into capsule  500  to see directly into working space  516 , or through a window in the wall of capsule  500 . Another visualization means is to removably attach the distal end of a flexible endoscope to capsule  500  as shown in FIG. 22. A scope adapter  600  removably attaches to the inside of channel  502  of capsule  500 . The distal end of endoscope  680  removably attaches to an adapter bore  681  of scope adapter  600 . A passage  603  in adapter  600  allows the passage of solid matter as described for the previous embodiments so that the solid matter does not impede the advancement of capsule  500 . Capsule  500  and adapter  600  may be constructed from a transparent material such as clear polycarbonate plastic. Also, endoscope  680  may be positioned within bore  681  so that working space  516  (FIG. 19) is within the field of view of endoscope  680 . The operator may then view tissue structure  13  on a display during the procedure.  
         [0047]    [0047]FIG. 20 illustrates sealing rings,  520  and  522 , which are fluidly connected to inflater  40  (FIG. 16), in an inflated configuration, thus isolating a circumferential portion  517  of wall  14 . A fluid  31  from fluid source  32  (FIG. 16) fills working space  516  and circumferential  517 . Using capsule  500  in this way, the operator may apply a small amount of fluid  31  to only diseased tissue and adjacent tissue, rather than expose a much larger portion of wall  14  to fluid  31 . FIG. 21 illustrates a medical instrument  524  inserted through port  517  for treatment of tissue structure  31 . After treatment of tissue structure  13 , the operator may deflate sealing rings,  520  and  522 , and move capsule  500  within bodily lumen  15  as described for the other embodiments. A balloon may also be constructed into capsule  500  so that capsule  500  may also be used for bowel preparation as described for the previous embodiments.  
         [0048]    While the present invention has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Further, various elements of the present invention can be equivalently described in terms of a means for accomplishing the elements&#39; associated functions.