Patent Publication Number: US-7896848-B2

Title: Ostomy tube device, ostomy placement kit and method for an ostomy tube placement

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
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     FEDERALLY SPONSORED RESEARCH 
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     SEQUENCE LISTING OR PROGRAM 
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     TECHNICAL FIELD 
     This invention relates to medical devices and methods, more particularly, to improved ostomy tube devices, ostomy placement kits and to methods for an ostomy tube placement. 
     BACKGROUND OF THE INVENTION 
     An ostomy placement as, for example, gastrostomy, jejunostomy, colostomy, ileostomy is utilized in medical profession for feeding patients with impaired swallowing but intact gut function as well as for decompression of overdistended hollow organs. While it is possible to create the ostomy by surgical procedure, recently less invasive endoscopic or fluoroscopic methods of percutaneous ostomy tube placement are widely employed. The percutaneous endoscopic gastrostomy (PEG) tube placement is one of the most commonly used prototypes of the ostomy placement. 
     The percutaneous endoscopic gastrostomy (PEG) tube placement, as it is described in U.S. Pat. No. 6,808,519, “involves introduction of a gastroscope into the stomach, while desired site where the stoma is to be created is indicated from above by depressing the abdomen. A sheathead needle punctures the abdominal wall and enters the stomach, creating the stoma. The needle is removed and a looped insertion wire is introduced through the sheath where it is grasped by a snare deployed from the working channel of the gastroscope. Once it is captured, the insertion wire is pulled into the channel of the gastroscope. The gastroscope is then withdrawn from the patient via the oral cavity, pulling the wire with it. In the standard Ponsky method (or “pull” method), the distal loop of a percutaneous gastrostomy feeding tube is coupled to the insertion wire loop exiting the patients mouth. With the insertion wire now tethered to the gastrostomy feeding tube, the endoscopist then retracts the insertion wire exiting the stoma, thereby pulling the gastrostomy feeding tube into the patient&#39;s mouth and on toward the stomach. The tapered dilator portion aids in allowing the gastrostomy feeding tube to pass through the stoma. Once the tube has been properly positioned with the end cap snugd against the internal wall of the stomach, the dilator portion of the gastrostomy feeding tube is cut away.” This technique was described initially by Jeffrey L. Ponsky and Michael W. L. Gauderer in “Percutaneous endoscopic gastrostomy: a nonoperative technique for feeding gastrostomy”, Gastrointestinal Endoscopy, Vol. 27, N0 1, 1981, pp 9-11. In addition to above steps in the Ponsky and Gauderer references cited above, “another rubber bumper is prepared and is positioned on the catheter (feeding tube) as it emerges from the abdominal wall”. “Rubber bumper” placed over the feeding tube, also known as external retention member, is slidably movable and frictionally retained over feeding tube. Once the feeding tube is secured in place, the Y-port adapter is connected to it. 
     Various types of gastrostomy tube devices were employed for percutaneous insertion by above “pull” method. Most gastrostomy tube devices, including commercially available from Wilson-Cook Medical Inc., Winston-Salem, N.C. or Boston Scientific Corporation, Watertown, Mass., comprise a tubular body having an internal retention member secured at one end, a dilator portion integrally attached at an opposite end, and a pull loop integrally formed and projecting outwardly from the dilator tip. 
     The percutaneous gastrostomy tube devices are preferably supplied in a kit form additionally including a guide wire, a needle catheter, an external retention member having a bore, and a snare. 
     There are problems associated with all three components (device, kit, method) of the above prior art technique. For example: 
     1. Commercially available gastrostomy tube devices with the dilator portion integrally attached to tubular body require sharp devices such as scissors or knife to cut away the dilator portion or the pull loop. 
     2. A gastrostomy tube device described in the Ponsky and Gauderer references cited above requires the time consuming assembly of several separate components in preparation for the operation. This also requires scissors or knife to cut off suture placed through the end of feeding tube. Alternatively time and effort are required to untie abovementioned suture from “guide-wire”, pull off cannula, and remove stitch passed through the end of feeding tube. Additionally placing the suture through the end of the feeding tube may result in partial or complete cutting through that end the feeding tube. This is especially true in cases of significant pull forces used.
 
3. The external retention member of the prior art is difficult to engage over the end of gastrostomy tube because of a smaller size of the bore.
 
4 The external retention member of the prior art is difficult to move along hollow flexible tube for 30-60 cm because of sliding friction.
 
5. The external retention member of the prior art is difficult to position accurately at abdominal surface level because of sliding friction
 
6. The guide-wire in the methods of the prior art is first pulled through the abdominal wall access to the mouth, to be then pulled from mouth to and through the abdominal wall access.
 
7. Use of the snare or any other grasping device suitable for passing through an endoscope is associated with several problems:
 
a) time and effort are required to advance the snare through about 130-150 cm long working channel of endoscope;
 
b) time and effort are required to remove the snare from about 130-150 cm long working channel of endoscope;
 
c) capturing of the guide-wire with a snare is complex maneuver requiring coordination of simultaneous movement of endoscope and snare in different direction;
 
d) an additional assistant is used to open and close the snare;
 
e) a snare occupies a lot of space in percutaneous gastrostomy kits;
 
i) a snare adds a cost to percutaneous gastrostomy kits.
 
     Present invention has various advantages over and addresses several of the shortcomings of previously described techniques: 
     1. Provides secure and releasable attachment between the hollow flexible tube, the pull-loop member, and the tapered cannula. This attachment is strong enough and, at the same time, easy to disengage. 
     2. Eliminates the need of sharp devices such as scissors or knifes to cut the hollow flexible tube, or a pull-loop member to release the hallow flexible tube. 
     3. External retention member coupled with tubular device is easy to engage over the end of the hollow flexible tube. 
     4. External retention member coupled with tubular device is easy to move along the hollow flexible tube. 
     5. Use of a tubular device with side opening provides an accurate positioning of the external retention member. 
     6. Use of a wire-loop device eliminates steps of pulling the guide-wire through abdominal wall access to the mouth. 
     7. Use of the wire-loop device eliminates complex step of capturing the flexible guide wire by snare device. 
     8. Use of the wire-loop device eliminates the need of using the snare or any other grasping device suitable for passing through an endoscope, whereby: 
     a) saves time and effort required to advance the snare through about 130-150 cm long working channel of endoscope, 
     b) saves time and effort required to remove the snare from about 130-150 cm long working channel of endoscope, 
     c) eliminates the need of the assistant to open and close the snare, 
     d) saves the space in percutaneous gastrostomy kits, 
     e) reduces the cost to percutaneous gastrostomy kits, 
     These and further objects and advantages of the present invention will become more apparent upon reference to the following drawings, ensuing description and appended claims. 
     SUMMARY OF THE INVENTION 
     The present invention provides an improved ostomy tube device, an improved ostomy placement kit and an improved method for an ostomy tube placement. 
     In accordance with the present invention, an ostomy placement kit in addition to an external retention member, a needle and a flexible guide wire, includes in different combinations: an ostomy tube device, a wire-loop device and a tubular device for delivering the external retention member over the ostomy tube device. 
     An ostomy tube device of the present invention comprise a hollow flexible tube with internal retention member secured at a first end and a tapered hollow cannula with a pull-loop member releasably attached to a second end. The tapered cannula has a wide portion ending by a wide end and a tapered portion ending by a tapered end, and a lumen open on both ends. The pull-loop member when positioned through the lumen of the tapered cannula forms a leading pole loop and a rear pole loop. The second end of the hollow flexible tube is folded over the rear pole loop and squeezed into the lumen of the wide portion of the tapered cannula, pulled by the rear pole loop. This configuration provides a secure and easy releasable attachment between the pull-loop member, the tapered cannula and the hollow flexible tube. In accordance with the present invention, the wire-loop device has a midportion rod with a wire-loop attached to one end and a handle attached to the other end. In further accordance with the present invention, the tubular device is constructed as a tube of about 3-5 cm from non collapsible, hard material with a lumen slightly bigger than the diameter of the hollow flexible tube of the ostomy tube device. The tubular device included in the ostomy placement kit, has the external retention member positioned over its leading end. The tubular device may have an additional opening on a side, communicating with its lumen. 
     In accordance with the present invention, a method for an ostomy tube placeman includes the following steps: (i) advancing an endoscope through a body opening into a lumen of a desired hollow organ, (ii) introducing a needle into the lumen of the desired hollow organ through an abdominal wall, (iii) passing a wire-loop of a wire-loop device through the needle into the lumen of the hollow organ, (iv) passing a flexible guide wire through the endoscope into the lumen of desired hollow organ, (v) positioning a second end of the flexible guide wire through the wire-loop of the wire-loop device, (vi) grasping the flexible guide wire by the wire-loop of the wire-loop device, (vii) pulling the second end of the flexible guide wire grasped by the wire-loop from the lumen of the hollow organ out through the abdominal wall, (viii) withdrawing the endoscope out of body opening and leaving the first end of the flexible guide wire extending out of body opening, (ix) securing the first end of the flexible guide wire to the leading pole loop of the ostomy tube device, (x) passing the ostomy tube device through the body opening, the lumen and the hollow organ wall, and the abdominal wall by pulling the flexible guide wire until the leading pole loop with the attached tapered cannula and the hollow flexible tube extend out of the abdominal wall and an internal retention member abuts against the inner surface of the hollow organ, (xi) releasing a second end of the hollow flexible tube from the attachment between the leading pole loop, the hollow flexible tube, and the tapered cannula by pulling apart the hollow flexible tube and the tapered cannula of the ostomy tube device, (xii) passing an external retention member positioned on a tubular device over the second end the hollow flexible tube and along the hollow flexible tube, (xiii) holding the hollow flexible tube, passed trough the lumen of the tubular device, against the tubular device by a finger through an additional opening on a side of the tubular device while removing the external retention member from the tubular device, (xiv) pulling off the tubular device from the hollow flexible tube. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       These and further features of the present invention will be apparent with reference to the following description and drawings, wherein: 
         FIG. 1A  is a sectional view of disassembled ostomy tube device of the present invention including a hollow flexible tube, a tapered cannula, and a pull-loop member of first embodiment. 
         FIG. 1B  is a schematic view of the pull-loop member of first embodiment. 
         FIG. 1C  is a schematic view of a pull-loop member of a tear droop shape. 
         FIG. 1D  is a schematic view of O-ring uninterrupted pull-loop member. 
         FIG. 1E  is a schematic view of a pull-loop member with two closed loops separated by a segment of the midportion of the flexible thread. 
         FIG. 1F  is a schematic view of a pull-loop member with two adjacent closed loops. 
         FIG. 1G  is a schematic view of a pull-loop member with two adjacent closed loops having different size. 
         FIG. 1H  is a sectional view of the tapered cannula with a pool-loop member positioned through its lumen with a first end of a flexible thread imbedded into the tapered cannula. 
         FIG. 1K  is a sectional view of the tapered cannula with a pool-loop member positioned through its lumen with a second end of the flexible thread imbedded into the tapered cannula. 
         FIG. 1L  is a sectional view of the tapered cannula with a pool-loop member positioned through its lumen with the first and the second ends of the flexible thread imbedded into the tapered cannula. 
         FIG. 2A  is a sectional view showing schematic relation between the hollow flexible tube, the tapered cannula, and the pull-loop member in process of assembling the ostomy tube device of present invention. 
         FIG. 2B  is a sectional view showing schematic relation between the hollow flexible tube, the tapered cannula, and the pull-loop member of assembled ostomy tube device of the present invention. 
         FIG. 3A  is a perspective schematic view of an external retention member having a disk configuration. 
         FIG. 3B  is a perspective schematic view of an external retention member having a tubular configuration. 
         FIG. 3C  is a perspective schematic view of an external retention member having a triangular configuration. 
         FIG. 3D  is a perspective schematic view of a tubular device of the present invention having an additional opening on a side. 
         FIG. 3E  is a perspective schematic view of the external retention member positioned over the tubular device according to the present invention. 
         FIG. 3F  is a perspective schematic view of the external retention member and the tubular device assembly passed over the hollow flexible tube according to the present invention. 
         FIG. 4A  is an external view of a needle. 
         FIG. 4B  is an external view of a wire-loop device of the present invention. 
         FIG. 4C  is an external view of the wire-loop device of the present invention passed through the needle. 
         FIGS. 5A-5F  sequentially illustrate the methodology for placing an ostomy tube using the wire-loop device, the ostomy tube device, and the tubular device of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     An ostomy tube device according to the present invention, as shown in  FIG. 1A , includes a hollow flexible tube  1  with a collapsible internal retention member  4  secured at a first end  2 , a tapered cannula  5  and a pull-loop member  9 . 
     The hollow flexible tube  1  has a first end  2 , a second end  3  and a lumen opened at both ends. Also, the hollow flexible tube  1  has a collapsible internal retaining member  4  surrounding the first end  2  and being secured thereto. 
     The collapsible retention member  4  may be either flat, having different configuration, or have dome shape, or mushroom shape, or constructed as inflatable balloon, or have any other construction. Generally speaking a collapsible internal retention member of any shape can be used in conjunction with this invention. The collapsible internal retaining member  4  may be secured to the hollow flexible tube  1  by heat sealing, adhesives, sonic bonding, integrally formed with the hollow flexible tube  1 , or attached to it. 
     Spacing indicia are provided along the hollow flexible tube to enable location of the device during installation, and during use. 
     The tapered cannula  5  has a wide portion ending by a wide end  8  and a tapered portion ending by a tapered end  6 . Also, the tapered cannula  5  has a lumen  7  opened on both ends. The lumen  7  of the wide portion of tapered cannula  5  is sized to accommodate folded twice and collapsed hollow flexible tube  1 . The lumen  7  of the tapered portion of tapered cannula  5  is sized to slidably accommodate the pull-loop member  9  passed through. The tapered cannula is made from semi-rigid, yet flexible, or rigid material. 
     The pull-loop member  9  is constructed from a flexible thread. The flexible thread is preferably made from a metal wire such as medical stainless steel wire, but can be made from any synthetic polymer material, as well as natural materials such as silk, and their combinations. 
     In first embodiment of the pull-loop member  9  a first and a second ends of the flexible thread are fastened together forming O shape closed loop as also shown on  FIG. 1B . 
     Alternatively, the first and the second ends of the flexible thread are fastened together forming a tear droop shape closed loop as in the pull-loop member  10  shown on  FIG. 1C . 
     Also, the pull-loop means can be constructed as O ring from uninterrupted flexible thread as in the pull-loop member  11  shown on  FIG. 1D . 
     In another embodiment of the pull-loop member the first and the second ends of the flexible thread are fastened to a midportion of the flexible thread separately and apart one from the other forming the pool-loop member  12  with two closed loops separated by a segment of the midportion of the flexible thread shown on  FIG. 1E . 
     Alternatively, the first and the second ends of the flexible thread are fastened together and to the midportion of the flexible thread forming the pool-loop member with two closed loops not separated by the segment of the midportion of flexible thread. Closed loops in such embodiment may have approximately equal size as in the pull-loop member  13  shown on  FIG. 1F , or one loop may be bigger then the other such as in the pull-loop member  14  shown on  FIG. 1G . 
       FIG. 1H  illustrates the pull-loop member constructed from the flexible thread having the first end  41  imbedded into the wall of the tapered cannula  5 , and the second end  42  fastened to midportion of the flexible thread forming a rear pole loop  16 . The flexible thread is passed through the lumen  7  of the tapered cannula  5  so that midportion of flexible thread extends from the tapered end  6  of the tapered cannula  5  forming a leading pole loop  15  while the rear pole loop  16  extends out of tapered cannula through the wide end  8 . 
       FIG. 1K  illustrates the pull-loop member constructed from the flexible thread having the second end  42  imbedded into the wall of the tapered cannula  5  and the first end  41  fastened to midportion of the flexible thread forming the leading pole loop  16 . The flexible thread is passed through the lumen  7  of the tapered cannula  5  so that midportion of flexible thread extends from the wide end  8  of the tapered cannula  5  forming the rear pole loop  16  while the leading pole loop  15  extends out of tapered cannula through the tapered end  6 . 
       FIG. 1L  illustrates the pull-loop member constructed from the flexible thread having the first end  41  and the second end  42  imbedded into the wall of the tapered cannula  5 . The flexible thread is passed through the lumen  7  of the tapered cannula  5  so that midportion of flexible thread extends from the tapered end  6  of the tapered cannula  5  forming the leading pole loop  15  and from the wide end  8  of tapered cannula  5  forming the rear pole loop  16 . 
       FIG. 2A  shows the pull-loop member  9  passed through the lumen  7  of the tapered cannula  5  so that part of the flexible thread extends from the tapered end  6  of the tapered cannula  5  forming the leading pole loop  15 , while other part of the flexible thread extends from the wide end  8  of the tapered cannula  5  forming the rear pole loop  16 . Similarly, the pull-loop member  10 , or  11 , or  12 , or  13 , or  14  depicted in  FIGS. 2B-2G , when passed through the lumen  7  of the tapered cannula  5 , form the leading pole loop  15  extending from the tapered end  6  of the tapered cannula  5  and the rear pole loop  16  extending from the wide end  8  of the tapered cannula  5 . While in further disclosure of the invention we will refer to the pull-loop member  9  all said will be equally applicable to all described above constructions of the pull-loop member. 
     In the process of assembling the ostomy tube device of present invention, as shown in  FIG. 2A , the second end  3  of the hollow flexible tube  1  is positioned through the rear pole loop  16  extending out of the wide portion of the tapered cannula  8  through the wide end  8 . Pulling the tapered cannula  5  and the leading pole loop  15  apart, moves the rear pole loop  16  into the lumen  7  of wide portion of the tapered cannula  5 . The second end  3  of the hollow flexible tube  1  folds over the rear pole loop  16  and squeezes into the lumen  7  of the wide portion of the tapered cannula  5  pulled by the rear pole loop  16 . Generally speaking, the hollow flexible tube  1  of any given diameter, when folded and squeezed, will fit into about the similar size lumen  7  of wide portion of tapered cannula  5 . Preferably, assembling of the ostomy tube devices of the present invention, as described above, will be done by manufacturer, while an operator, as a physician, will use already assembled device. 
       FIG. 2B  illustrates the ostomy tube device ( 1   a ) of the present invention in assembled configuration. As shown in this figure, the second end  3  of the hollow flexible tube  1  is folded over the rear pole loop  16  and squeezed into the lumen  7  of the wide portion of the tapered cannula  5  pulled by the rear pole loop  16 . This configuration provides a secure and releasable attachment between the pull-loop member  9 , the tapered cannula  5  and the hollow flexible tube  1 . This attachment is strong enough to overcome resistance forces on the ostomy tube device while it is pulled by the leading pole loop  15  through a lumen and a wall of a hallow organ (as, for example, stomach) and an abdominal wall. The second end  3  of the hollow flexible tube  1  is easy to disengage from the attachment with the pull-loop means  9  and the tapered cannula  5  by simply pulling apart the hallow hollow flexible tube  1  and the tapered cannula  5 . Approximately 1 to 3 cm (preferably about 2 cm) of the hollow flexible tube  1  from the second end  3  folded over the rear pole loop  16  is enough to provide strong and, at the same time, easy releasable attachment. 
     Possibility to release the hollow flexible tube  1  from the attachment with the tapered cannula  5  and the pull-loop member  9  eliminates the need of sharp devices as scissors, knifes, cutting pliers to cut the hollow flexible tube  1 , or a pull-loop member  9  to release said hallow flexible tube as was done in prior art. 
       FIGS. 3A-3C  show external retention members  18  of discoid, tubular, and triangular shape, respectively. Any such external retention member  18  has a bore  19  at about midportion. The bore  19  is sized slightly smaller than outer diameter of the hollow flexible tube  1  of the ostomy tube device of present invention. This size difference allows the bore  19  to accommodate and frictionally retain the hollow flexible tube  1 . A size difference of about 10-20 mils is employed in some prior art to provide friction fit between external retention members and hollow flexible tube. However, in prior art this size difference also causes sliding friction when external retention member is moved along hollow flexible tube for 30-60 cm from a second end  3  of hollow flexible tube to its final position against abdominal wall outer surface. Also in prior art this size difference makes it difficult to engage an initial segment of a second end  3  of hollow flexible tube  1  through smaller sized bore  19  of external retention member  18 . In one technique grasping forceps are passed through bore  19 , grasp second end  3  of hollow flexible tube  1  and pulls pull it back through bore  19 . In other technique a tapered dilator integrally attached to a hollow flexible tube is used to engage an initial segment of the hollow flexible tube through smaller sized bore of external retention members. Later technique requires first to cut off a distal wire loop from tapered dilator, and then, when external retention members is appropriately positioned over the hollow flexible tube, to cut off tapered dilator from the hollow flexible tube. These drawbacks of prior art are overcome by employment of a tubular device  20  for delivering the external retention member  18  over the hollow flexible tube described further. 
     A tubular device of this invention is constructed as a tube of about 3-5 cm having a leading end, a second end and a lumen opened at both ends. The diameter of the lumen of the tubular device is sized slightly bigger then the diameter of the hollow flexible tube  1  of the ostomy tube device. Size difference of about 0.5 mm allows to pass the tubular device over the second end  3  of hollow flexible tube  1 , and further along the hollow flexible tube  1  without substantial resistance. 
     The tubular device is made from non-collapsible, hard enough material as metal or plastic, or composite materials, or their combination to sustain elastic pressure of the external retention member  18  positioned over it without deformity of its lumen. 
       FIG. 3D  shows another embodiment the tubular device  20 , having an additional opening  21  on a side, communicating with its lumen. This additional opening  21  is big enough to accommodate one or more fingers of operator. 
       FIG. 3E  illustrates the external retention member  18  positioned over the leading end of the tubular device  20 . Preferably, assembling of the external retention member  18  and the tubular device  20  will be done by a manufacturer, while an operator, as a physician will use already assembled device. In process of assembly leading end of the tubular device is pushed through the bore of the external retention member. This process can be facilitated by using a cylindrical member with a tapered end positioned through the lumen of the tubular device  20  so that tapered end extends from leading end of the tubular device  20 . 
       FIG. 3F  shows external retention member  18  positioned over the leading end of the tubular device  20  passed over the hollow flexible tube  1  of the ostomy tube device. As was clarified earlier, external retention member  18  positioned over the leading end of the tubular device  20  will pass over the second end  3  of the hollow flexible tube  1  and further along the hollow flexible tube  1  without difficulty or substantial resistance. The additional opening  21  of the tubular delivery device  20  will allow operator to hold securely the hollow flexible tube  1 , passed through the lumen of said tubular device  20 , against said tubular device  20  using as few as two or three finger. This technique will prevent displacement of the tubular device  20  from the elected place along the hollow flexible tube  1  when the external retention member  18 , positioned over the tubular device  20 , and the tubular device  20  are pulled apart to remove the external retention member  18  from the tubular device  20 . As a result, this technique will allow accurate positioning of the external retention member  18  in elected place along the hollow flexible tube  1  close to the abdominal wall outer surfaces. 
     A means for delivering the external retention member to desired position over said hollow flexible tube, having a leading end, a second end and a lumen opened at both ends of the means, can be constructed in any shape and configuration provided that at least at one of its end, such as a leading end, the means will be non-collapsible enough to provide, when positioned through said bore of the external retention member, the lumen having size slightly bigger then the diameter of the hollow flexible tube  1  of the ostomy tube device. The means may have one or plurality side openings or splits of any configuration and size, communicating with the lumen of the means. Said openings or splits may or may not extend to one or both ends of the means as long as the lumen of the means with the external retention member positioned over the end, for example, the leading end will be slightly bigger then the diameter of the hollow flexible tube of the ostomy tube device. The tubular device of present invention is one of embodiments of said means for delivering the external retention member to desired position over said hollow flexible tube. 
       FIG. 4A  shows a needle  23  having a first end  30  that is placed into a lumen of a hallow hollow organ through an abdominal wall, a second end remaining outside of abdominal wall and a lumen open at both ends. While length and diameter of such a needle can vary, 16 or 18 gauge 8-10 cm needles are preferable. In prior art such needles were mainly used to place guide wire through abdominal wall into the lumen of hollow organ. 
       FIG. 4B  illustrates a wire-loop device  24  having a midportion rod  25 , with a wire-loop  27  attached to one end and a handle  26  attached to the other end. 
     The midportion rod  25  and the wire-loop  27  are sized in a diameter to be able to pass trough the lumen of the needle  23 , as is shown on  FIG. 4  C. Additionally, the midportion rod  25  is sized in length about the length of the needle  23  to allow the wire-loop  27  to extend out of the first end  30  of the needle  23  when the midportion rod  24  is completely engaged in the lumen of the needle  23 . When passed through the lumen of the needle  23  placed through abdominal wall into the lumen of hollow organ, the wire-loop device  24  opens and can grasp the end of a flexible guide wire, and pull it through the hollow organ and the abdominal wall outside of body. To grasp the end of the flexible guide wire, the handle  26  of the wire-loop device  24  is pulled away from the needle  23  pulling the wire-loop  27  inside the lumen of the needle  23 , of about 16 or 18 gauge, until flexible guide wire  28  is pressed against the first end  30  of the needle  23 . Rotating the plane of open wire-loop  27  by means of the handle  26  remaining outside of subjects body can help in positioning the end of the flexible guide wire  28  through the open wire-loop  27 . 
       FIGS. 5A-5F  illustrate the method of an ostomy tube placement of present invention. It is to be noted, that while  FIGS. 5A-5F  illustrate an ostomy tube placement through stomach  31  and abdominal wall  33 , also known as percutaneous gastrostomy tube placement, the method disclosed herein can be used in other areas of body, such as, for example, jejunostomy, colostomy, ileostomy. 
     As can be seen in  FIG. 5A  (with further reference to  FIGS. 4A-4C ), an endoscope  32  is advanced into the lumen of a desired hollow organ  31 , such as, stomach, in this example. Usually, endoscope is advanced to desired hollow organ through a natural body opening and natural tracts, as in illustrated case of stomach, through the mouth and the esophagus. In other applications, endoscope can be introduced also through artificial openings as gastrostomy, cecostomy, and ileostomy. The lumen of the hollow organ  31  is inflated with air for better visualization and manipulations. Under local or general anesthesia the first end  30  of the needle  23  is introduced into the lumen of the hollow organ  31  through the abdominal wall  33  while the second end of the needle  23  remains outside of abdominal wall  33 . After the first end  30  of the needle  23  is visualized in the lumen of the hollow organ  31 , the wire-loop  27  of wire-loop device  24  is passed through the needle  23  until wire-loop  27  completely extends from the first end  30  of the needle  23  and opens inside the lumen of the hollow organ  31 . A second end of a flexible guide wire  28  is introduced in a working channel of the endoscope and is passed through until appears in the lumen of the hollow organ  31 . At that point a first end (not shown on  FIG. 5A ) of the flexible guide wire  28  forming a loop remains extended from the working channel of endoscope outside of subject&#39;s body. Under endoscope visualization the second end of the flexible guide wire  28  is passed and positioned through open wire-loop  27 . This step can be facilitated by positioning the endoscope  32  perpendicularly to plane of open wire-loop  27 . Rotating the plane of open wire-loop  27  by means of the handle  26  remaining outside of subject&#39;s body can also help in this step. 
       FIG. 5B  shows the second end of flexible guide wire  28  grasped by the wire-loop devices  24  inside the lumen of the hollow organ  31 . To do this, the handle  26  of the wire-loop device  24  is pulled away from the needle  23  pulling the wire-loop  27  inside the lumen of the needle  23  until flexible guide wire  28  is pressed against the first end  30  of the needle  23 . While continuing grasping the flexible guide wire  28  in this manner, the wire-loop device  24  and the needle  23  are pulled together toward and through the hollow organ  31  wall and the abdominal wall  33 . The second end of the flexible guide wire  28  bends over the wire-loop  27  and follows through the hollow organ  31  wall and the abdominal wall  33  outside the abdominal wall. 
     While retaining the second end of the flexible guide wire  28  in position outside the abdominal wall  33 , the endoscope is withdrawn out of the body, leaving the first end of the flexible guide wire  28  extended out of the body natural opening, such as, mouth in this example. 
       FIG. 5C  illustrates an ostomy tube device comprising a hollow flexible tube  1  having a collapsible internal retaining member  4  secured at a first end, a tapered cannula  5  attached to a second end and a leading pole loop  16  attached and extended from a taper end of the tapered cannula  5 . The leading pole loop  16  of the ostomy tube device is secured to the first end of the flexible guide wire  28  extended through the body opening, mouth. In preferred embodiment the first end of the flexible guide wire  28  forms a loop  29 , thus, loop to loop coupling is used to secure the leading pole loop  16  of the ostomy tube device to first end of the flexible guide wire  28 . When the second end of flexible guide wire  28  is pulled out of the abdominal wall  33 , the ostomy tube device secured to the flexible guide wire  28  is pulled into the body opening and passes into the lumen of the hollow organ  31 . 
     Pulling further the flexible guide wire  28  out of abdominal wall  33  will draw the leading pole loop  16  with attached the tapered cannula  5  and the hollow flexible tube  1  through hollow organ  31  wall and abdominal wall  33  out of the abdominal wall as depicted in  FIG. 5D . At that point, the internal retention member  4  abuts against the inner surface of the hollow organ  13 . 
     The method of an ostomy tube placement described above and illustrated in  FIGS. 5A-5D  with use of the wire-loop device  24 , compared with the prior art, allows to improve technique, eliminating a step of passing the flexible guide wire through the needle in abdominal wall and lumen of hollow organ, and further out through natural body opening; eliminates a step of capturing of the flexible guide wire by a snare device introduced through the working channel of endoscope, requiring complex manipulation with the endoscope, the snare and cooperation with an assistant activating the snare; eliminates a step of engaging 150 cm long snare device through working channel of endoscope; eliminates a step of removing 150 cm long snare device out of working channel of endoscope; eliminates a need of using snare device or any other grasping device suitable for use through the endoscope, those devices are about 150 cm long, complex, and costly; eliminates a need of the assistant to help activate the snare device. In contrast with the snare device of the prior art, the wire-loop device  24  of present invention is simple and non costly; is small and requires less place for packaging; requires to be advanced only for about 15 cm; in best mode will be positioned inside the needle  23  by manufacturer and will requires to be advanced only for about 5-6 cm; is easy to be positioned and manipulated by a single person without help of the assistant. 
     In the method of an ostomy tube placement described above and illustrated in  FIGS. 5A-5D  the ostomy tube device of the present invention depicted in  FIGS. 2A-2B  and described in details above is used as preferred embodiment. However, any prior art ostomy tube device, as gastrostomy tube device, having a hollow flexible tube, an internal retaining member and a tapered cannula with a leading pole loop attached and extended from a taper end of the tapered cannula, can be alternatively used. 
     In another method of an ostomy tube placement, including all steps described above and illustrated in  FIGS. 5A-5D , using the ostomy tube device of the present invention depicted in  FIGS. 2A-2B  and described in details above, the following steps are performed additionally: the hollow flexible tube  1  and the tapered cannula  5  are pulled apart, releasing the second end  3  of the hollow flexible tube  1  from the attachment with the pull-loop member  9  and the tapered cannula  5 . Thus, use of the ostomy tube device of the present invention in the method of an ostomy tube placeman of the present invention eliminates the need of sharp devices such as scissors, knifes, cutting pliers to cut the hollow flexible tube  1  or a pull-loop member  9 , to release said hollow flexible tube, as was done in the prior art. 
     Turning to  FIG. 5E  (with further reference to  FIGS. 3E-3F ), the external retention member  18 , positioned over the leading end of the tubular delivery means device  20 , has been passed over the second end  3  of the hollow flexible tube  1 , and further along said hallow hollow flexible tube  1  up to the abdominal wall  33  outer surface. The hollow flexible tube  1 , passed trough the lumen of the tubular device  20 , is held against the tubular device  20  by a finger through the additional opening  21  on the side of the tubular device. At that point, the external retention member  18  is removed from the tubular device  20  and is positioned over the hollow flexible tube  1  in elected place next to the abdominal wall  33  outer surface. The tubular device  20  freed from the external retention member  18  is pulled off the hollow flexible tube  1  in retrograde direction. Thus, the tubular device  20  allows to overcome difficulties of prior art techniques in passing external retention member over the end  3  and along the flexible hollow tube  1 . 
       FIG. 5F  shows the hollow flexible tube  1  positioned through the hollow organ  31  wall and the abdominal wall  33  with the internal retention member  4  abutting against the inner surface of the hollow organ  33 , and the external retention member abutting against the abdominal wall  33  outer surface. A standard connecting union  34  is attached to the second end  3  of the hollow flexible tube  1  and is used for delivery of enteral nutrition, medications, and other fluids, or venting the hollow organ  33 . 
     An ostomy placement kit, in accordance with the present invention, includes an ostomy tube device, an external retention member, a needle and a flexible guide wire. The ostomy tube device, included in this kit and depicted in  FIG. 5C  and  FIG. 5D , comprise the hollow flexible tube  1  having the collapsible internal retaining member  4  secured at the first end, the tapered cannula  5  attached to the second end and the leading pole loop  16  attached and extended from the taper end of the tapered cannula  5 . The external retention member  18  modifications of this kit, depicted in  FIGS. 3   a - 3 C, have the bore  19  about midportion sized to accommodate and frictionally retain the hollow flexible tube  1  of the ostomy tube device. The needle of this kit, depicted in  FIG. 4A , has the first end  30  to be placed in the lumen of the hollow organ  31  through the abdominal wall  33 , a second end to remain outside of the abdominal wall, and the lumen open at both ends. The flexible guide wire  28  of this kit, shown in  FIG. 5C , has the first end forming the loop  29  and the second end. The flexible guide wire  28  is constructed from the flexible thread made either from a metal wire such as medical stainless steel wire, or from any synthetic polymer material such as nylon, or from natural materials such as silk, and their combinations. The length of the flexible guide wire  28  exceeds the length of used endoscope. 
     An alternative ostomy placement kit in addition to the ostomy tube device, the external retention member, the needle and the flexible guide wire includes a wire-loop device. The wire-loop device  24 , included in this kit and shown in  FIG. 4B , has the midportion rod  25  with the wire-loop  27  attached to one end and of the handle attached to the other end. The midportion rod  25  and the wire-loop  27  are sized in a diameter to be able to pass trough the lumen of the needle  23 , as is shown on  FIG. 4  C. Additionally, the midportion rod  25  is sized in length about the length of the needle  23  to allow the wire-loop  27  extend out of the first end  30  of the needle  23  when the midportion rode  24  is completely engaged in the lumen of the needle  23 . 
     Another alternative ostomy placement kit in addition to the external retention member, the needle, the flexible guide wire and the wire-loop device includes the ostomy tube device of present invention. The ostomy tube device of present invention included in this kit as depicted in  FIG. 2B  comprise the hollow flexible tube  1  having the first end  2 , the second end  3  and the lumen opened at both ends; the collapsible internal retention member  4  surrounding the first end  2  of the hollow flexible tube  1  and being secured thereto; the tapered cannula  5  having the wide portion ending by the wide end  8  and the tapered portion ending by the tapered end  6 , and the lumen open on both ends; the lumen of the wide portion of said tapered cannula  5  is sized to accommodate folded and collapsed the second end  3  of the hollow flexible tube  1 ; the pull-loop member  9  having the leading pole loop  15  and the rear pole loop  16 ; the pull-loop member  9  is passed through the lumen of the tapered cannula so that the leading pole loop  15  extends from the tapered end  6  of the tapered cannula  5 , and the rear pole loop  16  extends out of the wide portion of the tapered cannula  5  through the wide end  8 ; the second end  3  of the hollow flexible tube  1  is folded over the rear pole loop  16  and squeezed into the lumen  7  of the wide portion of the tapered cannula  5  pulled by the rear pole loop  16 . 
     Yet another alternative ostomy placement kit in addition to the ostomy tube device, the external retention member, the needle, the flexible guide wire and the wire-loop device includes the tubular device for delivering the external retention member over the hollow flexible tube. The tubular device for delivering the external retention member included in this kit is constructed as a tube of about 3-5 cm from non collapsible, hard material having a leading end, a second end and a lumen opened at both ends. The diameter of the lumen of the tubular device is sized slightly bigger then the diameter of the hollow flexible tube  1  of the ostomy tube device. Preferably, the tubular device included in this kit already has the external retention member  18  positioned over its leading end. 
     In another alternative ostomy placement kit, including the ostomy tube device, the external retention member, the needle, the flexible guide wire, the wire-loop device, and the tubular device for delivering the external retention member over the hollow flexible tube, the tubular device  20  has an additional opening  21 , communicating with the lumen of the tubular device  20 , as depicted in  FIG. 3D-3F . That additional opening  21  is big enough to accommodate a finger so that the finger will hold securely the hollow flexible tube  1 , passed through the lumen of the tubular device  20 , against the tubular device  20 . 
     An alternative ostomy placement kit in addition to the ostomy tube device of present invention, as depicted in  FIG. 2B , the external retention member, the needle, the flexible guide wire and the wire-loop device includes the tubular device for delivering the external retention member over the hollow flexible tube. The tubular device for the external retention member included in this kit is constructed as a tube of about 3-5 cm from non collapsible, hard material having a leading end, a second end and a lumen opened at both ends. The diameter of the lumen of the tubular device is sized slightly bigger then the diameter of the hollow flexible tube  1  of the ostomy tube device. Preferably, the tubular device included in this kit already has the external retention member  18  positioned over its leading end. 
     In another alternative ostomy placement kit including the ostomy tube device of present invention, as depicted in  FIG. 2B , the external retention member, the needle, the flexible guide wire, the wire-loop device, and the tubular device for the external retention member, the tubular device  20  has an additional opening  21 , communicating with the lumen of the tubular device  20 , as depicted in  FIG. 3D-3F . That additional opening  21  is big enough to accommodate a finger so that the finger will securely hold the hollow flexible tube  1 , passed through the lumen of the tubular device  20 , against the tubular device  20 . 
     Yet another alternative ostomy placement kit in addition to the ostomy tube device, the external retention member, the needle and the flexible guide wire includes the tubular device for the external retention member. The tubular device for the external retention member included in this kit is constructed as a tube of about 3-5 cm from non collapsible, hard material having a leading end, a second end and a lumen opened at both ends. The diameter of the lumen of the tubular device is sized slightly bigger then the diameter of the hollow flexible tube  1  of the ostomy tube device. Preferably, the tubular device included in this kit already has the external retention member  18  positioned over its leading end. 
     In an alternative ostomy placement kit including the ostomy tube device, the external retention member, the needle, the flexible guide wire and the tubular device for the external retention member, the tubular device  20  has an additional opening  21 , communicating with the lumen of the tubular device  20 , as depicted in  FIG. 3D-3F . That additional opening  21  is big enough to accommodate a finger so that the finger will hold securely the hollow flexible tube  1 , passed through the lumen of the tubular device  20 , against the tubular device  20 . 
     Another alternative ostomy placement kit in addition to the external retention member, the needle, the flexible guide wire and the tubular device includes the ostomy tube device of present invention. The ostomy tube device of present invention included in this kit as depicted in  FIG. 2B  comprise the hollow flexible tube  1  having the first end  2 , the second end  3  and the lumen opened at both ends; the collapsible internal retaining member  4  surrounding the first end  2  of the hollow flexible tube  1  and being secured thereto; the tapered cannula  5  having the wide portion ending by the wide end  8  and the tapered portion ending by the tapered end  6 , and a lumen opened on both ends; the lumen of the wide portion of said tapered cannula  5  is sized to accommodate folded and collapsed the second end of the hollow flexible tube  1 ; the pull-loop member  9  having said leading pole loop  15  and a rear pole loop  16 ; the pull-loop member  9  is passed through the lumen of the tapered cannula so that the leading pole loop  15  extends from the tapered end  6  of the tapered cannula  5 , and the rear pole loop  16  extends out of the wide portion of the tapered cannula  5  through the wide end  8 ; the second end  3  of the hollow flexible tube  1  is folded over the rear pole loop  16  and squeezed into the lumen  7  of the wide portion of the tapered cannula  5  pulled by the rear pole loop  16 . 
     In one more alternative ostomy placement kit, including the ostomy tube device of present invention, as depicted in  FIG. 2B , the external retention member, the needle, the flexible guide wire and the tubular device, the tubular device  20  has an additional opening  21 , communicating with the lumen of the tubular delivery means  20  as depicted in  FIG. 3D-3F . That additional opening  21  is big enough to accommodate a finger so that the finger will hold securely the hollow flexible tube  1 , passed through the lumen of the tubular device  20 , against the tubular device  20   
     Above described ostomy placement kits as in prior art are packaged in suitable container, sterilized and prepackaged in sterile sealed container. 
     INDUSTRIAL APPLICABILITY 
     The medical profession and enteral feeding industry has sought ways to simplify technique of ostomy placement, reduce time and manpower used, decrease the cost of ostomy kits, when possible eliminate use of sharp instruments. This invention solves these long-felt needs. 
     While the present invention has been described and illustrated in considerable detail with reference to certain preferred versions thereof, it is to be understood that numerous changes and modifications may be made therein, by those of ordinary skill in the art, without departing from the spirit and scope of the invention as defined in the appended claims.