Abstract:
A device for removing waste from the small intestine so that the colon can be repaired. The method of using the device includes the steps of forming an opening in the colon, inserting the device through the opening in the colon, passing a portion of the device through the ileocecal valve, inflating a balloon associated with the device such that the balloon contacts an inner wall of the small intestine, whereby the balloon prevents waste in the small intestine from passing by the balloon, flowing waste through the device and outside of the body, and repairing the colon.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention relates to a device for allowing repair of the colon, and more particularly to a catheter that diverts waste from the small intestine to the outside of the body, thereby allowing the colon to be repaired.  
         BACKGROUND OF THE INVENTION  
         [0002]    When a person has some type of injury to the colon, whether it be from a gunshot, an infection, a blockage, or any other type of problem, the typical procedure is to perform a colostomy.  
           [0003]    A colostomy is an alternative exit from the colon created to divert waste through a hole in the colon and through the wall of the abdomen. A colostomy is commonly performed by severing the colon to attach the end leading to the stomach to the skin through the wall of the abdomen. The end of the colon that leads to the rectum is closed off and becomes dormant. Usually a colostomy is performed for infection, blockage, or in rare instances, severe trauma of the colon. A colostomy is often performed so that an infection can be stopped and/or the affected colon tissues can heal.  
           [0004]    In the past, a colostomy generally required that the bowel be extended out from an abdominal incision. A colostomy pouch, usually supported by a belt or girdle, was kept constantly in position to receive the fecal matter discharged during the colostomy. The colostomy pouch or bag is a removable, disposable bag that attaches to the exterior opening (stoma) to permit sanitary collection and disposal of bodily wastes. This arrangement is extremely objectionable due to the frequent escapage of foul odors and leakage of the fecal matter onto the body and wearing apparel. In one type of known colostomy procedure, instead of a belt or girdle, the colostomy bag is fixedly positioned against the outside of the abdominal wall with an adhesive. The disadvantage of using an adhesive is that the adhesive often causes irritation, which chafes or macerates the abdominal skin.  
           [0005]    Generally, a colostomy is in place for a period of three to six months. The colostomy often entails complications that are resolved by performing additional surgeries. Even if there are no complications, at the end of the three to six month period, an additional surgery must be performed to remove the colostomy bag and stitch the two parts of the colon back together. These surgeries are major procedures and require recovery time for the patient. The hospital stay after the closing of a colostomy typically requires 4-5 days and results in an additional expense for the colostomy patient.  
           [0006]    A colostomy is particularly important when the colon suffers a perforation, such as from a gunshot or stabbing. If the perforation is not repaired, the patient may die within a matter of hours. The flow of waste through the colon must be stopped to prevent the seepage of waste from the perforation. The flow of waste must also be stopped to allow the perforation to be repaired. Often in a severe perforation situation there is not enough time to perform a colostomy, which usually results in the patients death.  
           [0007]    A long felt need exists for a method and device that limits the amount of time that a colon repair patient must spend in surgery, and that allows colon repair surgery to be quick and easy to perform.  
         SUMMARY OF THE PREFERRED EMBODIMENTS  
         [0008]    In accordance with a first aspect of the present invention there is provided a catheter for removal of waste from an intestine. The catheter is preferably used in conjunction with a cecostomy and controlled ileostomy to facilitate the lesion restoration of the colon. The catheter includes an outer tube having first and second ends, an inner tube having first and second ends, and which is concentric with the outer tube, a balloon associated with the first end of the inner tube, and an inlet member including an inlet opening associated with the second end of the inner tube.  
           [0009]    The first and second ends of the inner tube extend outside of the first and second ends respectively of the outer tube. A channel is defined between the inner tube and the outer tube. In a preferred embodiment, the outer tube has an opening defined therein for allowing gas in the colon to pass into the outer tube and out of the second end (and, therefore, outside the body).  
           [0010]    The device is intended to be used in a surgical procedure with an animal, preferably a human, body. As a result of the procedure, the second ends of the inner and outer tubes and the inlet member extend through an opening in the colon, the inner tube extends through the ileocecal valve, and the first end of the inner tube extends into the small intestine.  
           [0011]    In accordance with another aspect of the present invention there is provided a method of repairing the colon. The method includes the steps of forming an opening in the colon, inserting the catheter through the opening in the colon, passing a portion of the device through the ileocecal valve, inflating a balloon associated with the device such that the balloon contacts an inner wall of the small intestine, whereby the balloon prevents waste in the small intestine from passing by the balloon, flowing waste through the catheter and outside of the body, and repairing the colon.  
           [0012]    In accordance with another aspect of the present invention there is provided a method of removing waste from the small intestine. The method includes the steps of forming an opening in the colon, inserting the device through the opening in the colon, passing a portion of the catheter through the ileocecal valve, inflating a balloon associated with the device such that the balloon contacts an inner wall of the small intestine, whereby the balloon prevents waste in the small intestine from passing by the balloon, and flowing waste through the catheter and outside of the body. In a preferred embodiment, the method includes the step of passing gas from the colon through an opening in the outer tube and outside of the body.  
           [0013]    In accordance with another aspect of the present invention there is provided a medical device that includes a pair of concentric tubes. Each tube has opposed ends, the outer tube has an opening between its ends and one end of one of the tubes is balloonable.  
           [0014]    In accordance with another aspect of the present invention there is provided a medical device that includes a pair of concentric tubes including an inner tube and an outer tube each having opposed ends and a balloon disposed adjacent an end of one of the tubes and in flow communication with a fluid inlet member.  
           [0015]    The fluid inlet member is disposed adjacent an end of one of the tubes opposite the balloon for facilitating inflation of the balloon. The end of the inner tube opposite the balloon is adapted for connection to a waste receiving member, such as a colostomy bag.  
           [0016]    Other objects, features and advantages of the present invention will become apparent to those skilled in the art from the following detailed description. It is to be understood, however, that the detailed description and specific examples, while indicating preferred embodiments of the present invention, are given by way of illustration and not limitation. Many changes and modifications within the scope of the present invention may be made without departing from the spirit thereof, and the invention includes all such modifications. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0017]    The invention may be more readily understood by referring to the accompanying drawings in which  
         [0018]    [0018]FIG. 1 is a elevational view showing a portion of a colon with the appendix extending therefrom and the small intestine connected to the colon.  
         [0019]    [0019]FIG. 2 is a elevational view of a device for allowing repair of the colon in accordance with a preferred embodiment of the present invention. The device is shown in an environment wherein it has been inserted into the colon, through the ileocecal valve and into the small intestine of a human body.  
         [0020]    [0020]FIG. 3 is a cross-sectional elevational view similar to FIG. 2, showing the inner components of the device for allowing repair of the colon.  
         [0021]    [0021]FIG. 4 is a cross sectional end view taken along line  4 -- 4  of FIG. 2. 
     
    
       [0022]    Like numerals refer to like parts throughout the several views of the drawings.  
       DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0023]    Referring generally to FIGS.  1 - 4 , a first embodiment of a medical device or catheter  10  for allowing repair of the colon is shown. The device  10  generally includes an inner tube  12 , a balloon  14 , an outer tube  16  and a fluid inlet member  18 . It will be appreciated that terms such as “below,” “forwardly,” “rearwardly,” “upwardly,” “downwardly” and “sideways” used herein are used merely for ease of description and refer to the orientation of the components as shown in the Figures.  
         [0024]    It should be understood that any orientation of the device  10  described herein is within the scope of the present invention. As used herein, the term fluid means having particles that easily move and change their relative position without a separation of the mass and that easily yield to pressure. Any liquid or gas is a fluid within the scope of the present invention.  
         [0025]    Referring to FIG. 1, the colon  100  is part of the large intestine, which is the tubelike organ that completes the process of digestion, receiving material from the small intestine  106 . The large intestine has four parts: the cecum, the appendix  102 , the colon  100 , and the rectum. Once the products of digestion enter the cecum through the ileocecal valve  104  (which separates the large and small intestines), they move rapidly past the appendix, which juts out from the intestine near the cecum. The colon absorbs any remaining water and forms the stool, which is send to the rectum for elimination. The walls of the large intestine are muscular, and contract to move material along its length.  
         [0026]    The small intestine  106  is the tubelike organ that receives the products of digestion from the stomach. The small intestine has three parts: the duodenum, the jejunum, and the ileum. The ileum ends with the ileocecal valve, which prevents food passed into the large intestine from traveling back into the small intestine  106 . The walls of the small intestine  106  are muscular, and contract to move digested food along its length. The intestinal tube is lined with a mucus-like tissue that sends forth tiny, finger-like projections called villi. The villi increase the surface available for absorbing nutrients from digested food.  
         [0027]    As discussed above, the appendix  102  is part of the large intestine. It is a small, finger-shaped pouch of intestinal tissue that juts out into the volume between the small intestine  106  and large intestine.  
         [0028]    Referring to FIGS.  2 - 4 , the inner tube  12  is hollow and is to be used for diverting the waste or fecal matter within the ileum to the outside of the body. The inner tube  12  has a first end  20  for receiving the waste, and an opposite second end  21  for disposing the waste outside of the body and preferably into a bag  23 . The inner tube  12  is preferably formed of a plastic or rubber material that is safe to use in the body. In a preferred embodiment, the inner tube is formed of two layers, a first or inner layer  22  that is formed of a rigid plastic, and a second or outer layer  24  that is formed of a more pliable plastic or rubber. It will be understood that the inner tube  12  can be formed of a single layer or of multiple layers.  
         [0029]    The balloon  14  is formed of an elastic plastic or rubber material and is preferably formed in the second layer  24  of the inner tube, adjacent the first end  20  of the tube. In another embodiment, the balloon  14  can be attached to the outside surface of the inner tube  12 . When the device  10  is positioned within the small intestine and the balloon  14  is inflated, the balloon  14  fully occupies the space between the device  10  and the inside surface of the small intestine. The inflated balloon  14  completely blocks the waste flowing through the small intestine and fully diverts the waste into the first end  20  of the inner tube  12 . In a preferred embodiment of the invention, the balloon  14  has a volume of 35 cubic centimeters when fully inflated.  
         [0030]    The balloon  14  is filled with air or liquid by a narrow tubular member  26  that preferably extends between first and second layers  22 ,  24  of inner tube  12  and terminates in an opening  18   a  in fluid inlet member  18 . The tubular member  26  extends into the inside of balloon  14  for inflation thereof. In another embodiment, the tubular member  26  can be attached to the inside surface of inner tube  12 . In yet another embodiment, the tubular member  26  can be formed inside the wall of inner tube  12 , such as by molding.  
         [0031]    Devices for filling balloon  14  are well known in the art. For example, the device may include a one way valve that is attached to an inlet end of the tubular member  26  at fluid inlet member  18 , or a second tubular member may be connected to fluid inlet member  18  and the one way valve connected to an inlet end of the second tubular member. It will be understood that any device that is in fluid communication with the tubular member  26  and is capable of inflating balloon  14  with fluid is within the scope of the present invention.  
         [0032]    The inner tube  12  is concentric with the outer tube  16 . The outer tube  16  is preferably formed of a plastic or rubber material that is safe to use in the body. In a preferred embodiment of the invention, the outer tube has a rigid, L-shaped form and is approximately 27 to 30 cm in length. As shown in FIG. 3, an opening  28  is formed in the outer tube  16  in a location such that it will be positioned in the colon  100  after placement of the device  10  within the body. As will be described below, gas in the colon will exit the body through opening  28 . A space  30  is defined between the inner and outer tubes  12 ,  16  to allow gas to pass through the outer tube  16 . The outer tube  16  is preferably not as long as the inner tube  12 . The portion of the inner tube  12  that includes the balloon  14  extends outside the outer tube  16  so that the balloon  14  has room to inflate. The outer tube  16  includes a first end  32  and a second/gas disposal end  34 . In a preferred embodiment, the inner tube  12  is secured within the outer tube  16  by glue or other adhesive. However, it will be understood that the inner tube  12  may be secured inside the outer tube  16  by any known method. For example, the concentric tubes may be formed integrally with another, such as by molding.  
         [0033]    To begin the procedure of positioning the device  10  within the patient, a small incision is made in the lower right side of the abdomen  107  at a location to afford access to the appendix  102 . The appendix  102  is then removed. The removal of the appendix is a common procedure and for sake of efficiency will not be described here. After removal of the appendix  102 , an incision  108  is made in the colon  100  where the appendix  102  was formerly located. In an alternative embodiment, an incision can be made adjacent the appendix  102 , without having to remove the appendix.  
         [0034]    The first end  20  of the inner tube  12  is inserted into the incision in the abdomen and the incision  108  in the colon  100 . The first end  20  is then passed through the ileocecal valve  104  and into the ileum of the small intestine  106 . In a preferred embodiment of the invention, the device is inserted in the ileocecal valve  104  approximately 15 cm. The first end  34  of the outer tube  16  is also passed through the incision  108  and the ileocecal valve  104 . Because the outer tube  16  is used to evacuate gas from the colon  100 , the outer tube  16  may be short enough that it does not pass through the ileocecal valve  104 . In other words, it is only important that the inner tube  12  passes through the ileocecal valve and into the ileum. Due to the musculature of the colon  100 , the incision  108  remains tight around the outer tube  16 , as shown in FIG. 3.  
         [0035]    After the device  10  has been positioned appropriately, a device for inflating the balloon  14  is placed in fluid communication with the tubular member  26  and the balloon  14  is inflated to a point where the small intestine  106  is sealed so that no waste can pass between the wall of the small intestine  106  and the balloon  14 . After the balloon  14  has been inflated, because the small intestine  106  is blocked, the waste in the small intestine  106  enters the first end  20  of the inner tube  12  and passes therethrough to the second end  21  and exits into the bag  23  or other disposal apparatus. Colostomy bags are well known in the art. Therefore the type of bag  23  used for the present invention is not limiting.  
         [0036]    Because the waste from the small intestine  106  is diverted outside of the body and not into the colon  100 , the colon  100  remains empty and can then be repaired. After the surgery for inserting the device  10  and repairing the colon  100 , the colon must then heal. The healing process varies from patient to patient and can take anywhere from about fifteen days to six weeks. The amount of time the device  10  is left in place is not a limitation on the present invention.  
         [0037]    After the colon  100  has been allowed to heal, the device  10  can then be removed from the patient&#39;s body. To remove the device  10 , the balloon  14  is deflated, and the device  10  is pulled back through the ileocecal valve  104 , the incision  108  in the colon (where the appendix was) and the incision in the abdominal wall. The musculature of the sphincter of the ileocecal valve  104  regains its tone when the device  10  is withdrawn, regardless of the length of time that the device was left therein. Accordingly, the requirement of suturing of the colostomy is eliminated.  
         [0038]    The device of the present invention and the method of placement of the device allow the restoration of lesions in the colon in a fast, convenient, and cost-effective manner. A typical colostomy usually requires the patient to wear the colostomy bag and an uncomfortable girdle for three to six months, after which a second surgery is required to reattach the sections of the colon and remove the colostomy bag. The present invention requires a single surgery, avoids the above-mentioned inconveniences during the several months of convalescence that is required for known colostomy procedures, and saves the patient the cost and inconvenience of a second surgery to either correct the complications of the colostomy or to close the colostomy. Moreover, the patient does not need to purchase accessories to ensure hygienic conditions on the patient&#39;s body.  
         [0039]    The embodiments of the present invention recited herein are intended to be merely exemplary and those skilled in the art will be able to make numerous modifications to them without departing from the spirit of the present invention. All such modifications are intended to be within the scope of the present invention as defined by the claims appended hereto.