WO1996032904A1

WO1996032904A1 - Prosthesis for bowel evacuation control-colostomy tube

Info

Publication number: WO1996032904A1
Application number: PCT/SI1995/000009
Authority: WO
Inventors: Pavel KOS^¿OROK; Peter METLIKOVIC^¿; Pavel Munih
Original assignee: Sava Kranj, Industrija Gumijevih, Usnjenih In Kemic^¿Nih Izdelkov, P.O.
Priority date: 1995-04-20
Filing date: 1995-04-20
Publication date: 1996-10-24
Also published as: SI9600124A; HRP960172A2

Abstract

The problem which is solved by a prosthesis for bowel evacuation control at the incontinence of an artificial or natural anus in accordance with the invention is how to provide simple, safe and reliable control of bowel evacuation in artificial or natural incontinence, where under artificial incontinence colostomy, i.e. a surgically formed opening in the large intestine through the abdominal wall is understood, and under natural incontinence the incontinence of the anal sphincter is understood. The illustrated prosthesis inserted in a colostomy, i.e. a bowel (1) extended through the abdominal wall (2), consists of an inner ring (3) which continues into a pellicular tube (4) and this into a faceplate (5), and of a cover (8). In this embodiment the inner ring (3) is carried out as a ring made of pliable, organism-friendly material with a built-in reinforcement (9) providing a sufficient force for reexpansion of the ring (3) and preventing its deformation when being inserted into the bowel lumen. The inner ring (3) continues along its entire circumference into the tube (4) whose thin walls are made of a material with similar characteristics as the inner ring (3). The diameter of an unstretched tube (4) is a little smaller than the diameter of the inner ring (3). The length of the tube (4) in this embodiment is a little smaller than the thickness of the abdominal wall (2). At the end lying opposite to the inner ring (3) the tube (4) continues into a faceplate (5) which is preferably of circular form and made of firm material or dimensioned so that it is firm yet pliable. The plate (5) has an opening in the centre in which the cover (8) is inserted which prevents the faeces from escaping.

Description

PROSTHESIS FOR BOWEL EVACUATION CONTROL - COLOSTOMY TUBE

The invention relates to a prosthesis for bowel control - colostomy tube, designed for controlling artificial or natural incontinence of bowel evacuation and for solving the difficulties at rectal prolapse. The prosthesis for bowel evacuation control in accordance with the invention provides simple, safe and reliable evacuation control in artificial or natural incontinence.

The problem which has not yet been solved in a satisfactory way, and which has been solved by a prosthesis for bowel evacuation control in accordance with the invention, is how to provide simple, safe and reliable bowel evacuation control in artificial or natural incontinence and at difficulties of rectal prolapse, where under artificial incontinence a stoma is understood, i.e. an opening in the large intestine made surgically through the abdominal wall, and under natural incontinence the incontinence of the anal sphincter is understood.

The described problem is known to have been solved in various ways. The most frequent way of treating stoma is by collecting intestinal contents using adhesive colostomy bags - self-adhesive bags or skin barrier bags. One of known methods is also stomal irrigation. There also exists plugging of the anus.

Technically more complicated solutions of the problem of artificial incontinence are roughly divided into four groups.

The first group concerns various types of adhesive collection bags, i.e. self-adhesive closed or unclosed bags. The drawback of these bags is that they irritate the skin under the adhesive surface. More recent solutions in this group are two-piece systems, where the skin barrier with a retension ring remains adhered to the skin all the time, while the bag is exchangeable.

The second group includes various plugging devices which are insertable into the bowel lumen. These include e.g. an inflatable balloon which acts as a tampon and lies in the colon, and which is described in an article by Tenney JB, Graney MJ: The quest for continence: A morphologic survey of approaches to a continent colostomy. Dis Colon Rectum 1978, 21 :552. Another solution in this group is a "control button" consisting of a rubber plug and an aluminium skin plate. This solution is described in the US patent 2 510 766. The third typical solution in this group is a colostomy plug with the commercial name Conseal (Coloplast). It is made of an adhesive baseplate and a colostomy plug. Into a standard skin base a retention ring is inserted as in the two-part system. Instead of a collection bag the plug is plugged into an extension on the baseplate. The inserted plug is made of polyurethane foam and coated with a thin film which holds the foam together. The wetness of the bowel causes the thin film to dissolve, and the plug expands to obtain a bell-like shape with the wider part in the bowel lumen. When the plug is removed, a simple collection bag can be placed in its place, the bag being sealed at the place of the retention ring. The solution is described in the work of Burchart F, Ballan A, Kyllberg F, Rasmussen SN: The colostomy plug a new disposable device for continent colostomy. Lancet 1986:1062.

The third group concerns a combination of surgical intervention and a passive implant. Typical solutions in this group are a magnetic valve with the commercial name Maclet System and Prager's plug, where an inner ring is operatively sewn around the stoma, while an inflatable balloon is inserted through the artificial anus supported by the ring.

The last group concerns artificial sphincters, such as Buuck's patent, Giori's patent, Summes's patent, a circumferential balloon sphincter proposed by Heilblum and Cordoba, and Szinicz's sphincter.

The solving of the problem of natural incontinence is surgical sometimes with insertion of a mechanical support and techniques of stimulating muscular activity.

The described solutions reveal the fact that the problem of simple, safe and reliable control of bowel evacuation in artificial or natural incontinence and difficulties at rectal prolapse has not yet been solved in a satisfactory way, as the adhesive bags irritate the skin, and the collection and drainable bags are disturbing to the user. The problem of all sorts of plugs is that they have to be constantly taken out and put directly into the stoma or anus, which is unpleasant and can cause intestine lesions.

The task of the invention is to avoid the above mentioned drawbacks of known solutions and to enable simple, safe and reliable control of faeces evacuation in natural as well as artificial incontinence, and in difficulties at rectal prolapse.

In accordance with the invention, the problem has been solved through a prosthesis for bowel evacuation control as claimed in the main Claim, which provides simple, safe and reliable control of bowel evacuation in artificial or natural incontinence. The invention will be further described by way of example and with reference to drawings in which:

Figure 1 illustrates the first embodiment of a prosthesis inserted in the stoma;

Figure 2 illustrates the second embodiment of a prosthesis inserted in the stoma;

Figure 3 illustrates a non-deformed cover;

Figure 4 illustrates a deformed cover during insertion;

Figure 5 illustrates a deformed inserted cover;

Figure 6 illustrates a deformed cover during extraction.

Figure 1 illustrates a prosthesis for bowel evacuation control of anal incontinence according to the first embodiment inserted in a colostomy, i.e. a bowel 1 extended through the abdominal wall 2, consisting of a reexpandable inner ring 3 which continues into a tube 4, of a faceplate 5 and a cover 8. In this embodiment the inner ring 3 is made of pliable, organism-friendly material which is reinforced in the inside by a reinforcement 9. The reinforcement 9 is designed as a narrow spring ring and preferably made of thermoplastic. Said reinforcement 9 prevents a spatial deformation of the inner ring 3 but it allows the inner ring 3 to deform in the plane, which is important for the insertion of the prosthesis in the stoma, which will be additionally described. At the same time, the reinforcement 9 provides sufficient force for the reexpansion of the inner ring 3, which is important for safe anchoring and sealing. The inner ring 3 continues along its entire circumference in one piece into a pedicular tube 4 which is made of a thin-walled material of the same or similar characteristics as the inner ring 3. The diameter of an unstretched tube 4 is a little smaller than the diameter of the inner ring 3. The length of the tube 4 when assembled is a little smaller than the thickness of the abdominal wall 2. Onto the skin of abdominal wall 2 a faceplate 5 is laid centrically to the stoma, said faceplate 5 having preferably a circular shape and being made of a firm material, or dimensioned so that it is firm, yet pliable. In the centre of the faceplate 5 an opening is made in the shape of a flap 6 which at the same time forms a ring-shaped bearing 7. Into the opening, i.e. under the flap 6 according to Figure 1 , a cover 8 is inserted to prevent the faeces from escaping. It is understood that instead of a cover inserted into the opening as illustrated by Figure 1 , i.e. in the flap 6, it is also possible to insert a gas permeable cover with a built-in filter and a connector for a collection or drainable bag, for irrigation, etc.

The prosthesis in accordance with the invention according to the first embodiment is applied by assembling the tube 4 and the plate 5 with regard to the thickness of the abdominal wall 2, so that the end of the tube 4 lying opposite the inner ring 3 is pulled through the opening of the plate 5, then wound over the flap 6 so that it snaps into position in the bearing 7. The inner ring 3 is then diametrically pressed together by e.g. the forefinger and the thumb and pushed longitudinally into the bowel lumen 1 under the abdominal wall 2 in such a way that the tube 4 is facing the opening and that the plate 5 is outside the bowel 1. The inserted inner ring 3 in the bowel 1 reexpands into an annulus. At the same time, the pliable tube 4 presses the inner ring 3 against the wall of the bowel 1 at the inner side of the abdominal wall 2 thus enabling reliable anchoring and sealing and holding the faceplate 5 against the skin. In this way a simple, safe and reliable outlet from the stoma is created which is both exchangeable and hygienic.

The prosthesis for bowel evacuation control in artificial or natural incontinence according to the second embodiment, as illustrated by Figure 2, is inserted in a colostomy, i.e. a bowel 1 extended through the abdominal wall 2, consisting of an inner ring 3 which continues in one piece into a tube 4, and this in one piece into a faceplate 5, and of a cover 8. The inner ring 3 with a reinforcement 9 is made in the same way as in the first embodiment. The inner ring 3 continues along its entire circumference into a pellicular tube 4 which is made of a thin-walled material of the same or similar characteristics 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 end lying opposite the inner ring 3 the tube 4 continues in one piece into the faceplate 5 which is preferably of circular shape and made of a firm material or dimensioned so that it is firm, yet pliable. The plate 5 is open in the centre. At its beginning, i.e. close to the passage of the tube 4 into the plate 5, the plate 5 is fitted along its inner circumference of the opening with a circular groove 10. As illustrated by Figure 2, a cover 8 is inserted into the opening which when snapped into position in the groove 10, prevents the faeces from escaping.

The prosthesis in accordance with the invention according to the second embodiment is applied by pressing the inner ring 3 diametrally with the forefinger and the thumb and pushing the pressed ring 3 longitudinally into the bowel lumen 1 under the abdominal wall 2 in such a way that the tube 4 is facing the opening. The inserted inner ring 3 in the bowel lumen 1 under the abdominal wall 2 reexpands into an annulus, while the plate 5 lies on the skin centrical ly with regard to the stoma. At the same time the pliable tube 4 presses the inner ring 3 against the wall of the bowel 1 in the inner side of the abdominal wall 2 thus providing the anchoring and sealing and holding the plate 5 against the skin. In this way a simple, safe and reliable outlet from the stoma is created which is both exchangeable and hygienic.

Figure 3 illustrates the cover 8 which is in both embodiments preferably constructed as a hollow plug with relatively thin walls and made of pliable, yet firm material. Basically, the cover 8 has the shape of a spindle, its bottom 11 being slightly conical and passing into a stopping ring 12. The height of the circumference 14 is, when applied in the first embodiment, slightly bigger than when applied in the second embodiment. The top of the cover 8 is bent over into a cap 13. The purpose of such a structure will be described by means of Figures 4, 5 and 6. As described before, the cover 8 may be additionally equipped with filters or replaced by a connector for a collecting or drainable bag, irrigation, etc.

Figure 4 illustrates the deformation of the cover 8 during its insertion into the opening of the plate 5. The described structure of the cover 8 causes, due to the deformation, a decrease of the diameter of the bottom 11 and the ring 12, which facilitates the pressing of the cover 8 into the opening of the plate 5.

Figure 5 illustrates the deformation of the inserted cover 8 under the pressure P of the faeces /excrements against the bottom 11. The described structure of the cover 8 causes, in this case, an increase of the diameter of the bottom 11 and the ring 12 and thereby the force B, and firm holding of the cover 8 in the opening of the plate 5 or in its groove 10.

Figure 6 illustrates the deformation of the cover 8 during its extraction from the opening. The rim of the cap 13 allows for an easy and firm grip with fingers. As force F is pulling the cover in one point out of the opening of the plate 5, the cover 8 gets deformed so that the ring 12 jumps out of the opening, and the extraction of the cover 8 is made easier.

The prosthesis for incontinence control of a natural anus is basically the same as those already described, with the difference being that the geometry of the plate 5 and the cover 8 and thereby also partially the tube 4 are adapted to the geometry of the tissue on which lies the plate 5.

All elements of the prosthesis for bowel evacuation control are made from elastic materials which should meet the medical requirements. Latex and silicone have proven as the most suitable materials.

Claims

CLAIMS:

1. A prosthesis for bowel evacuation control in natural or artificial incontinence, characterised in that an inner ring (3) passeses into a narrower thin-walled tube (4) being at the opposite end in a detachable or non-detachable way linked with a faceplate (5), and that said inner ring (3) contains a reinforcement (9).

2. A prosthesis for bowel evacuation control as claimed in Claim 1 , characterised in that the reinforcement (9) is carried out as a narrow and relatively high spring ring.

3. A prosthesis for bowel evacuation control as claimed in Claim 1 , characterised in that the plate (5) has an opening in the centre carried out in the form of a flap (6) forming at the same time a ring- shaped bearing (7).

4. A prosthesis for bowel evacuation control as claimed in Claim 1 , characterised in that at the end opposite to the inner ring (3) the tube (4) continues in one piece into the lying plate (5) which is open in the centre and fitted at the first part along its inner circumference of the opening with a circular groove (10).

5. A prosthesis for bowel evacuation control characterised in that the cover (8) is a hollow plug, whereby the bottom (11) is slightly conical and passing into a stopping ring (12), and the top is bent into a cap (13).