Dilation Device for Placing Catheter Tubes

1 . A stoma dilation device comprising:

a tubular support defining a continuous pathway through the device;

an inflatable dilation balloon located on the tubular support, the inflatable balloon including a dilation region forming a first portion of the device and a retention region forming a second portion of the device; and

a balloon inflation lumen,

wherein the retention region is configured to have a diameter upon full, unrestrained inflation that is greater than the diameter of the dilation region upon inflation.

2 . The stoma dilation device of claim 1 , wherein the inflatable balloon is made of a compliant material, a non-compliant material, or a semi-compliant material and combinations thereof.

3 . The stoma dilation device of claim 2 , wherein the dilation region and the retention region of the inflatable balloon are each made of different materials.

4 . A stoma dilation device comprising:

a tubular support having a length, width and a longitudinal axis, the tubular support defining a continuous pathway through the device;

an inflatable dilation balloon oriented axially on the tubular support, the inflatable balloon including a dilation region forming a first portion of the device and a retention region forming a second portion of the device; and

a balloon inflation lumen,

wherein the retention region is configured to have a diameter upon full, unrestrained inflation that is greater than the diameter of the dilation region upon inflation.

5 . The stoma dilation device of claim 4 , wherein inflatable balloon is made of a compliant material, a non-compliant material, or a semi-compliant material and combinations thereof.

6 . The stoma dilation device of claim 5 , wherein dilation region and the retention region of the inflatable balloon are each made of different materials.

7 . A system for dilating a stoma and inserting a non-vascular catheter tube, the system comprising:

a stoma dilation device comprising:

a tubular support having a length, width and a longitudinal axis, the tubular support defining a continuous pathway through the device;

an inflatable dilation balloon oriented axially on the tubular support, the inflatable balloon including a dilation region forming a first portion of the device and a retention region forming a second portion of the device; and

a balloon inflation lumen,

wherein the retention region is configured to have a diameter upon full, unrestrained inflation that is greater than the diameter of the dilation region upon inflation, and

a non-vascular catheter tube configured to fit over the fully or partially inflated dilation region through the dilated stoma tract and into the portion of the non-vascular lumen stabilized by the retention region,

wherein the stoma dilation device is configured to be deflated and at least a portion of the device withdrawn through the non-vascular catheter tube.

8 . The stoma dilation device of claim 7 , wherein inflatable balloon is made of a compliant material, a non-compliant material, or a semi-compliant material and combinations thereof.

9 . The stoma dilation device of claim 8 , wherein dilation region and the retention region of the inflatable balloon are each made of different materials.

10 . A method of placing a PEG device including the steps of:

advancing an endoscope into a non-vascular lumen to insufflate and allow palpation to locate a PEG tube location site;

inserting a needle into a stomach through the non-vascular lumen and introducing a guide wire through the needle;

inserting standard endoscopic forceps, an endoscopic snare, or a balloon attachment fixture through the working channel of the endoscope;

grasping the guide wire and pulling said guide wire up through the endoscope and out of a patient's mouth;

securing a dilation device with its attached inflation lumen to the end of the guide wire and is pulling said dilation device through the endoscope using the guide wire, and into the stomach;

removing said needle from the lumen, while retaining the guide wire in the needle tract;

pulling the dilation device up into and partially through the needle tract;

inflating a balloon of said dilation device by gradually introducing controlled amounts of a fluid to increase pressure in the balloon so the balloon smoothly and gradually expands the needle tract into a stoma tract while bringing a wall of said lumen against an abdominal wall;

placing a peel-away sheath over the dilation device, deflating said balloon by only a small amount to allow the peel-away sheath to pass over the distal end of the dilation device and through the stoma tract into the stomach;

threading a PEG device over the guide wire and inserting the PEG device inserted through the peel away sheath;

fully deflating the balloon and withdrawing said balloon through the peel-away sheath;

separating said peel-away sheath and removing it.

11 . The method of placing a PEG device of claim 10 wherein a said dilation device comprises:

a tubular support having a length, width and a longitudinal axis, the tubular support defining a continuous pathway through the device;

an inflatable dilation balloon oriented axially on the tubular support, the inflatable balloon including a dilation region forming a first portion of the device and a retention region forming a second portion of the device; and

a balloon inflation lumen,

wherein the retention region is configured to have a diameter upon full, unrestrained inflation that is greater than the diameter of the dilation region upon inflation.