HRP960172A2 - Prothesis for bowel evacuation control-colostomy tube - Google Patents

Description

The invention relates to a bowel control prosthesis or colostomy tube intended to control artificial or natural bowel incontinence and to resolve rectal prolapse difficulties. The bowel control prosthesis according to this invention enables simple, safe and reliable bowel control in case of artificial or natural incontinence.

The problem that has not been satisfactorily solved until now, and which is solved by the prosthesis for bowel control according to this invention, is how to ensure simple, safe and reliable control of bowel movements in case of artificial or natural incontinence and in the case of difficulties due to rectal prolapse, where artificial incontinence means a stoma , that is, a surgical opening in the large intestine made through the abdominal wall, and natural incontinence means anal sphincter incontinence.

The described problem has been solved in different ways so far. Most often, the intestinal content that comes out of the stoma is collected in adhesive colostomy bags - self-adhesive bags or bags with a skin barrier. Also, one of the known methods is washing the stoma. Anus plugging is also used.

Technically more complicated solutions to the problem of artificial incontinence can be roughly divided into four groups.

In the first group, there are different types of self-adhesive bags, that is, self-adhesive closed or open bags. The disadvantage of the bags is that they irritate the skin under the sticky surface. A newer solution in this group are the two-part systems, where the partition and retention ring are permanently attached to the skin and the bags are replaceable.

In the second group are various blocking devices that are inserted into the intestinal lumen. This includes the balloon that is inflated and lying in the intestine acts as a buffer, which is described in the article by J.B. Temiev and M.J. Granev: "The search for continence: a morphological review of the approach to continence colostomy". Dis Colon Rectum 1978, 21:522. Another solution in this group is the "control knob" which consists of a rubber plug and an aluminum partition on the skin. This solution is described in US Patent 2,510,766. A third typical solution is a colostomy plug under the trade name Conseal (Coloplast). It consists of a self-adhesive base plate and a colostomy plug. A retention ring is inserted into the standard base next to the skin as a two-part system. Instead of a collection bag, a plug is inserted into the extension of the base plate. The inserted plug is made of polyurethane foam coated with a thin film that holds the foam together. Due to the humidity of the intestine, the thin film dissolves and the plug expands and takes on a bell-shaped shape in the wider part of the intestinal lumen. When the plug is removed, a simple collection bag is placed and floats on the retaining ring. This solution is described in the paper Burchart F., Kyllberg F. Rasmussen S.N.: "Colostomy plug: a new replaceable means of achieving colostomy continence". Lanciet 1986:1062.

The third group includes a combination of surgery and a passive implant. A typical solution from this group is the magnetic valve under the trade name Maclet Svstem and the Prager plug, where the inner ring is operatively sewn around the stoma while the inflation balloon is inserted through the artificial anus supported by the ring.

The last group includes artificial sphincters such as Buuck's patent, Giori's patent, Summes' patent, the circular balloon sphincter proposed by Heilblum and Cordoba, and the Szinicz sphincter.

The problem of natural incontinence is solved surgically, sometimes a mechanical foundation is placed along with techniques to stimulate muscle activity.

The described solutions point to the fact that the problem of simple, safe and reliable bowel control in artificial or natural incontinence and difficulties due to rectal prolapse have not been satisfactorily solved so far, self-adhesive bags irritate the skin, and collection bags and bags that can be dried burden user. The disadvantage of all types of plugs is that they must be constantly removed and placed in the stoma or anus, which is unpleasant and can cause lesions on the intestine.

The task of this invention is to avoid the mentioned disadvantages of known solutions and to enable simple, safe and reliable control of the discharge of feces in natural as well as in artificial incontinence, and to solve difficulties in rectal prolapse.

According to the present invention, the problem is solved by a bowel control prosthesis as stated in the main claim, which provides simple, safe and reliable bowel control in natural and artificial incontinence.

The invention will be further described through an example and with reference to the corresponding figures where:

Figure 1 shows the first setting of the prosthesis placed in the stoma;

Figure 2 shows the second setting of the prosthesis placed in the stoma;

figure 3 shows the cover before bending;

figure 4 shows the bent cover during insertion,

Figure 5 shows an inserted bent cover;

figure 6 shows the bent cover during removal;

Figure 1 shows a prosthesis for controlling bowel movement in anal incontinence placed in a colostomy according to the first arrangement, that is, the intestine 1 extends through the abdominal wall 2, and consists of an inner expandable ring 3 that continues into a tube 4, from the outer plate 5 and cover 8. In this arrangement, the inner ring 3 is made of a flexible material adapted to the organism, which is internally reinforced by a reinforcement 9. The reinforcement 9 is made as a narrow ring spring and is preferably made of thermoplastic material. Said reinforcement 9 prevents the spatial deformation of the inner ring 3, but enables bending of the plane of the ring 3, which is important when inserting the prosthesis into the stoma, which will be further described. At the same time, the reinforcement 9 enables sufficient force to re-stretch the inner ring 3, which is important for secure fastening and sealing. The inner ring 3 continues along its entire circumference in a piece in a thin (diaphragm-like) tube 4 made of thin-walled material with the same or similar characteristics as the inner ring 3. The diameter of the unstretched tube 4 is slightly smaller than the diameter of the inner ring 3. The length of the tube 4 at the assembled prosthesis is slightly smaller than the thickness of the abdominal wall 2. An external plate 5 is placed on the skin of the abdominal wall, which should preferably be in the middle of the stoma and be made of solid material or of such dimensions that it is strong yet flexible. In the middle of the outer plate 5, an opening formed into a valve 6 is made, which at the same time creates an annular bearing 7. In the opening, that is, under the valve 6, according to Figure 1, a cover 8 is placed, which prevents the excrement from coming out. It goes without saying that instead of the cover placed in the opening as in Figure 1, a gas-permeable cover with a built-in filter and a connection for a bag for collection or drainage, for flushing, and so on, can be placed in the valve.

The prosthesis in accordance with the invention and according to the first setting is placed by assembling the tube 4 and the plate 5 according to the thickness of the abdominal wall 2 so that the end of the tube 4 opposite to the inner ring 3 is passed through the opening of the plate 5 and then it is screwed over the flap 6 so that it clicks to close in its position in the bearing 7. The inner ring 3 is then compressed diametrically with the index finger and the thumb is pushed longitudinally into the lumen of the intestine 1 under the abdominal wall 2 in such a way that the tube 4 looks towards the opening and gives the plate 5 outside the intestine 1. Insert the inner ring 3 into the intestine 1 expands and creates an annular space. At the same time, the flexible tube 4 is pressed against the inner ring 3 against the wall of the hose 2, thus enabling reliable fixing and sealing and holding of the outer plate 5 on the skin. In this way, a simple safe and reliable discharge from the stoma is created that is replaceable and at the same time hygienic.

The prosthesis for controlling bowel movement in case of artificial or natural incontinence according to the second setup, shown in Figure 2, is inserted into the colostomy, that is, the intestine 1 extends outside the abdominal wall 2, and (the prosthesis) consists of an inner ring 3 that continues in in one piece into the tube 4 and it in one piece into the outer plate 5, and the cover 8. The inner ring 3 with reinforcement 9 is made in the same way as in the first setup. The inner ring 3 continues along its entire circular surface into a membrane tube 4, which is made of a thin material with the same or similar properties as the inner ring 3. The diameter of the tube 4 is smaller than the diameter of the inner ring 3. The length of the tube 4 is smaller than the thickness of the abdominal wall. 2. At the opposite end of the inner ring 3, the tube 4 continues in one piece into the outer plate 5, which is preferably circular in shape and made of solid material or dimensioned so that it is strong yet flexible. Plate 5 has an opening in the middle. At the beginning, that is near the transition of the pipe 4 to the plate 5, the plate 5 is fixed along its inner circle in the circular groove 10. As shown in Figure 2, the cover 8 is placed in the opening which is then closed (by clicking) on place in slot 10, preventing spillage of excrement.

The prosthesis according to the invention and in accordance with the second setting is placed by squeezing the inner ring 3 diametrically with the index finger and thumb and pushing the ring 3 longitudinally into the lumen of the intestine 1 under the abdominal wall 2 so that the tube 4 faces the opening. The inserted inner ring 3 in the intestinal lumen 1 under the abdominal wall 2 expands into the annular space while the plate 5 lies centrally in relation to the stoma. At the same time, the flexible tube 4 presses the inner ring 3 against the gut wall 2 on the inner side of the abdominal wall 2, thus enabling a reliable fastening and sealing and placement of the outer plate 5 on the skin. In this way, a simple safe and reliable discharge from the stoma is created that is replaceable and at the same time hygienic.

Figure 3 shows the lid 8 which in both setups is preferably constructed as a relatively thin walled hollow plug and made of a flexible yet strong material. Basically, the cover 8 has the shape of a spindle, its bottom 11 is slightly conical and passes through the sealing ring 12. The height of the circular part 14, when used in the first setting, is slightly higher than when used in the second setting.. The upper end of the cover 8 is formed into a cap 13. The purpose of such an embodiment is described with reference to Figures 4, 5 and 6. As previously described, filters can be additionally placed in the cap 8 or replaced with a connection for bags for collecting or filtering, rinsing, etc.

Figure 4 shows the deformation of the cover 8 when it is inserted into the opening of the plate 5. The described design of the cover 8 causes, due to the deformation, a reduction in the diameter of the bottom 11 and the ring 12, which makes it easier to press the cover 8 onto the opening of the plate 5.

Figure 5 shows the deformation of the inserted cover 8 under the pressure P of feces/excreta on the bottom 11. The described design of the cover 8 causes, in this case, an increase in the diameter of the bottom 11 and the ring 12 and thus the force B and a firm holding of the cover 8 in the opening of the plate 5 or the groove 10.

Figure 6 shows the deformation of the cover 8 when it is removed from the opening. The edge of the cap 13 allows easy and firm grip with the fingers. When the force F pulls the cover out of the opening of the plate 5 at one point, the cover 8 is deformed so that the ring 12 pops out of the opening and thus facilitates the removal of the cover 8.

The prosthesis for controlling incontinence of the natural anus is basically the same as those previously described with the difference in the geometry of the plate 5 and the cover 8, and thus the tube 4 is also somewhat adapted to the geometry of the tissue on which the plate 5 lies.

All parts of the prosthesis for defecation are made of elastic materials that must meet medical requirements. Rubber and silicone proved to be the most suitable materials.

Claims (5)

1. For a prosthesis for bowel control in case of artificial or natural incontinence, it is characteristic that the inner ring (3) passes into a narrower tube with thin walls (4) which is connected on the opposite side to the outer plate (5) in such a way that it can be to separate it or in such a way that it cannot be separated from it, and said inner ring (3) has reinforcement (9). 2. For the bowel control prosthesis from claim 1, it is characteristic that the reinforcement (9) is made as a narrow and relatively high ring spring. 3. For the bowel control prosthesis from claim 1, it is characteristic that the plate (5) has an opening in the form of a valve (6) which simultaneously represents an annular bearing (7). 4. For the bowel control prosthesis from claim 1, it is characteristic that at the opposite end of the inner ring (3) the pipe (4) continues in one piece into the lying plate (5) is open in the middle and fixed in the first part along the inner circles into the hole with the circular slot (10). 5. For the bowel control prosthesis from claim 1, it is characteristic that the cover (8) has a hollow plug whose bottom (11) is slightly conical and which passes through the closing ring (12) and the outer edge is shaped into a cap (13) ).