Abstract:
A fixation mechanism used for attaching a flexible line or any other catheter extending through the abdominal wall or percutaneously applied in any other location during a percutaneous endoscopic gastrostomy (PEG). The fixation mechanism utilizes a cover plate fitted with a support base through which the flexible line ( 10 ) is placed. In order to attach the flexible line, a barrel vault-shaped body is folded and clicked into a closed position. The flexible line extending outside the abdominal wall ( 14 ) is then folded at an angle of 90° without appreciably changing its cross-sectional pre-insertion dimensions.

Description:
This application claims priority under 35 U.S.C. §365(c) based on the PCT Application No. PCT/DE98/03285, filed Nov. 10, 1998 and having a priority date of Nov. 11, 1997 based on German Patent Application No. 197 49 741.1. 
     FIELD OF THE INVENTION 
     This invention relates to the field of percutaneous endoscopic gastrostomy (PEG) and, in particular, attaching a percutaneously applied flexible line or tube to the skin. 
     BACKGROUND OF THE INVENTION 
     The problem of fixating a PEG tube or line in position on a patient&#39;s skin is well known in the art. A typical solution is disclosed in WO 94/08648. This device is primarily used during a percutaneous endoscopic gastrostomy (PEG) and serves as fixation device for a percutaneous catheter. During a percutaneous endoscopic gastrostomy, as described in DE 9112338U1, a cannula is inserted into the stomach through a hole that is placed in the abdominal wall. A suture is then thread through the cannula. Using an endoscope, the end of the suture is grasped and guided up through the patient&#39;s mouth. The suture is then attached to the flexible line or tube and the tube is guided down through the esophagus into the stomach and out through the abdominal incision where the flexible line leaves percutaneously. One end of the line is attached to the inner abdominal wall of the stomach. The flexible line or cannula serves for example as catheter for enteral feeding. 
     To avoid unintentional movement, a fixation device is required at the outside of the abdominal wall. A typical fixation device is disclosed in WO 94/08648 comprising a covering plate with a hole for the flexible line that is attached to the patient&#39;s abdominal wall. On top of the cover plate, there is a supporting plate with an open channel on its edge having in its cross section the shape of a semicircle. In the first area, the channel runs vertically to the cover plate, and after bending in the second area, it runs parallel to the cover plate. The result achieved is that the flexible line leaves the patient&#39;s body vertically but is then rerouted parallel to the skin surface. The cover plate in both mentioned areas has solidly affixed mechanisms that close the channel&#39;s aperture and constitute eyelets through which the flexible line has to pass. 
     However, one difficulty in using the above-mentioned fixation device as well as other prior art devices is that during the process of inserting the flexible line into the fixation device, the flexible line changes diameter. A fixation device that does not cause the diameter of the flexible to appreciably change, provides a simple insertion of the flexible line and an easy way to move it to for adaptation to the individual situation, can operated single handedly, and enables the fixation of the flexible line in a 90° angle without the flexible line becoming crimped or bent is not found in the prior art. 
     SUMMARY OF THE INVENTION 
     The invention comprises a fixation device that presses the flexible line into a supporting wall having a channel, and a pivotally hinged securing mechanism (barrel-vault shaped body) to secure the flexible line that is flexibly attached to the cover plate. The hole for the passage of the flexible line is located between the barrel-vault shaped body&#39;s axis and the supporting wall. Therefore, the barrel-vault shaped body can be turned in the direction of the flexible line. If it is open, the flexible line passes through the cover plate directly. In closing, the barrel-vault shaped body takes hold of the flexible line and bends it onto the supporting plate&#39;s surface. With the barrel-vault shaped body open, the cover plate can be easily moved and adjusted, whereas the flexible line is fixed if the barrel-vault shaped body is closed. The fixation happens solely by using the tension in the flexible line material; consequently, its diameter remains substantively unchanged. The flexible line does not crimp or bend. This is important to guarantee an optimal and undisturbed flow of liquid through the flexible line. Another feature of the invention is the one-hand-operability of the fixation mechanism. The cover plate can easily be moved with the open barrel-vault shaped body and the fixation mechanism can be closed and locked by using only one hand. 
     The invention is preferably equipped with a cover plate made of soft and elastic material, while the barrel-vault shaped body is made of a stiff material. A cover plate made of soft and elastic material enables a tactile comfortable application to the patient&#39;s skin and can be used as fixation mechanism to arrest the barrel-vault shaped body at the same time. 
     Preferably, the barrel-vault shaped body comprises a preformed channel, that together with the channel on the supporting plate forms a cross section with the shape of a circle that covers the flexible line and keeps it in shape. This securely prevents the flexible line from being bent even if the flexible line is being pulled. 
     The cover plate preferably is made in a triangular shape and, at the side of the supporting wall, has triangular wings. The hole for the passage of the flexible line preferably is located close to the center of this triangle, allowing an even dispersion of pressure and avoiding local concentrated pressure. This means an optimal wearing comfort that is important because the fixation mechanism can be utilized together with a catheter for long-term enteral feeding; hence, it can be used for long periods of time. Additionally there is the possibility of plaster fixation. 
     Another part of the invention is a gastrostomy-set that comprises a flexible line with a retaining element and a fixation mechanism. The barrel-vault shaped body and the flexible line are attuned in a way that prevents the flexible line from being crimped or bent and keeps its tubular shape from compressing. 
     These aspects of the invention are not meant to be exclusive and other features, aspects, and advantages of the present invention will be readily apparent to those of ordinary skill in the art when read in conjunction with the following description, appended claims and accompanying drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a perspective view of the fixation mechanism in accordance with the invention before its fixation to a flexible line that percutaneously enters the abdominal wall. 
     FIG. 2 is a cross-sectional view of the fixation mechanism in the direction of the arrow  11  as shown in FIG.  1 . 
     FIG. 3 is a cross-sectional view along line III—III of FIG. 2 with the fixation mechanism closed. 
     FIG. 4 is a top view of the fixation mechanism. 
     FIG. 5 is a cross-sectional view on the fixation mechanism in direction of arrows V—V of FIG.  3 . 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The invention is a fixation device that allows a simple insertion of the flexible line and an easy way to move it to for adaptation to the individual situation, and on the other hand enables the fixation of the flexible line in a 90° angle without the flexible line becoming crimped or bent. The invention comprises a fixation device that presses the flexible line into a channel of a supporting wall and a pivotally hinged securing mechaism (barrel-vault shaped body) to secure the flexible line that is flexibly attached to a over plate. The hole for the passage of the flexible line is located between the barrel-vault shaped body&#39;s axis and the supporting wall. Therefore, the barrel-vault shaped body can be turned in the direction of the flexible line. If it is open, the flexible line passes through the cover plate directly. In closing, the barrel-vault shaped body takes hold of the flexible line and bends it onto the supporting plate&#39;s surface. With the barrel-vault shaped body open, the cover plate can be easily moved and adjusted, whereas the flexible line is fixed if the barrel-vault shaped body is closed. The fixation happens solely by using the tension in the flexible line material; consequently, its diameter remains unchanged. The flexible line does not crimp or bend. This is important to ensure an optimal and undisturbed flow of liquid through the flexible line. 
     The invention also permits one-hand-operability of the fixation mechanism. The cover plate can easily be moved with the open barrel-vault shaped body and the fixation mechanism can be closed and locked by using only one hand. 
     The cover plate is preferably made of soft and elastic material, while the barrel-vault shaped body is made of a stiffer material. Having the cover plate made of soft and elastic material enables a tactile comfortable application to the patient&#39;s skin and can be used as fixation mechanism to arrest the barrel-vault shaped body at the same time. 
     Preferably, the barrel-vault shaped body comprises a preformed channel, that together with the channel on the supporting plate forms a cross section with the shape of a circle that covers the flexible line and keeps it in shape. This securely prevents the flexible line from being bent even if the flexible line is being pulled. 
     The cover plate preferably is made in a triangular shape and, at the side of the supporting wall, has triangular wings. The hole for the passage of the flexible line preferably is located close to the center of this triangle, allowing an even dispersion of pressure, comprising a cover plate with a hole for the flexible line, whereas the plate folds the flexible line at an angle of 90°. 
     As shown in FIG. 1, flexible line  10  is used as enteral catheter. The flexible line  10  has a retaining element  11  at its end with the shape of a dish and a sling  13  at its sling attachment end  12 . The flexible line  10  is inserted into the stomach through the esophagus with its sling attachment end  12  first. It exits distally through the previously punctured abdominal wall  14  and the inner side stomach wall  15  with the help of a suture attached to the sling  13 . Then, the sling attachment end  12  of the flexible line  10  can be pulled out of the patient&#39;s body with the retaining element  11  remaining at the inner side stomach wall  15 . The flexible line  10  is fixed by fixation mechanism  16 , which is applied from the outside to the patient&#39;s skin. 
     The fixation mechanism  16  comprises cover plate  18  that essentially has the shape of a triangle with three equal sides and with rounded corners. In the cover plate  18 , there is aperture  19  to allow the flexible line  10  to pass through. The sling attachment end  12  of the flexible line  10  is put through this aperture  19  and the cover plate  18  is threaded onto and moved along the flexible line  10  until its underside rests upon the skin  17 . 
     The cover plate  18  has a support base  20  vertically attached with a support channel  21  on top of it. This support channel  21  has a cross-section of a semicircle and is dimensioned to accommodate approximately one-half the diameter surface of flexible line  10 . The support channel  21  runs, as shown in FIG. 3, in the shape of the bow  22  to the aperture  19 . The flexible line  10  is being bent in the bow  22  in a 90° angle at the support base  20  and runs in the support channel  21  parallel to the cover plate  18 . 
     At the cover plate  18 , barrel vault-shaped body  23  is installed, which is attached to the pivotal axis  24 . The aperture  19  is located between the pivotal axis  24  and the support base  20 . The pivotal axis  24  is attached to the barrel vault-shaped body  23  and anchored in the side parts  25  of the cover plate  18 . The side parts  25  are elevated at the side of the support base  20 . Between the support base  20  and the side parts  25 , there are locking grooves  26 . (see FIG.  5 ). 
     The barrel vault-shaped body  23  has the shape of a stretched shovel with two parallel side flanks  27  and a vault-shaped middle part  28  connecting the side flanks  27 . There are locking element  29  connected to the side flanks  27  that lock into the side parts  25  if the barrel vault-shaped body  23  is put in its locking position according to FIG.  3 . The barrel vault-shaped body  23  comprises a channel  30  (see FIG. 5) in the shape of a semicircle, which is embedded into the support base  20  of the support channel  21  which closes over the flexible line  10  forming a tunnel around the flexible line  10 . This channel  30  goes through the bending area of the barrel vault-shaped body  23  opposite of the bow  22 , so that the barrel vault-shaped body  23  entirely holds and forms the flexible line  10 . The flexible line&#39;s  10  diameter, which is formed by the support channel&#39;s  21  and channel&#39;s  30  profile, corresponds to the outer diameter of the flexible line  10 , so that it can hold the flexible line  10 . The flexible line  10  is fixated by means of the 90° angle and the friction of the line  10  against the supporting tunnel. 
     The closed barrel vault-shaped body  23  can be flipped to the open position by grabbing the handle  31  (see FIG. 5) at the end of the barrel vault-shaped body  23 . By applying force to open the barrel vault-shaped body  23 , the locking element  29  is pushed out of its resting location. The barrel vault-shaped body  23  can be put into its locking position at the cover plate  18  by merely pressing it down. The cover plate  18  is preferably made of soft and elastic material, while the barrel vault shaped body  23  preferably is made of hard or less elastic plastic. 
     As FIG. 4 shows, the cover plate  18  has the basic shape of a triangle. At both sides of the barrel vault-shaped body  23 , there are triangular wings  33 . At the triangular wings  33 , the cover plate  18  is very thin and highly flexible. These triangular wings  33  can be affixed with bandages to the patient&#39;s skin. The triangular wings  33  do not have sharp edges and thereby achieve equal distribution of pressure on the patient&#39;s skin without the danger of punctual imprints on the patient&#39;s skin. The aperture  19  is located adjacent to the center point of the cover plate  18  and aligned with support base  20  and pivotal axis  24 . 
     After the flexible line  10  is set up as shown in FIG. 1, the fixation mechanism  16  is mounted on the flexible line  10  and attached to the skin  17 . By moving the fixation mechanism  16  on the flexible line  10 , the appropriate distance of the fixation mechanism  16  from the retaining element  11  can be determined. To simplify this, there are metering marks on the flexible line  10  (not shown). Next, the barrel vault-shaped body  23  is pressed down and locked with the locking element  29 . Finally, the locking element  29  and the triangular wings  33  of the cover plate  18  are attached with bandages to the patient&#39;s body. If necessary, the barrel vault-shaped body  23  can be reopened to service and/or readjust the fixation mechanism  16  and/or administer to the patient. 
     Although the present invention has been described in considerable detail with reference to certain preferred versions thereof, other versions would be readily apparent to those of ordinary skill in the art. Therefore, the spirit and scope of the appended claims should not be limited to the description of the preferred versions contained herein.