A CATHETER
The present invention relates to a catheter for drainage of fluids from a bodily cavity comprising a flexible drainage tube which is provided with a drain opening in the distal end portion of the drainage tube and an inflatable balloon portion adjacent said drain opening, which encompasses the tube for retaining said tube when inserted in the bodily cavity, said balloon portion being encompassed by a tubular basket member with slittings, which is fastened to the drainage tube.
A catheter of this kind is known from US-A-2,854,983. A catheter of this kind is used as urinary catheter for permanent use. The advantage of such balloon catheter is that the balloon in the distal end of the drainage tube of the catheter retains the catheter when it is inserted in the body cavity, such as a bladder. By inflating the balloon with air, the tubular member around the balloon is stretched and forms a cone-shaped basket in front of the balloon. Hereby, the possibility of draining above the balloon at the distal end portion of the drainage tube is provided, where the fluid can flow through the drain opening at the end and into the drainage tube of the catheter. The cone-shaped basket which is formed by the tubular member by the inflation of the balloon prevents that the wall of bodily cavity comes into contact with the drain opening and therefore ensures the flow of fluid through the drain opening and into the inner space of the drainage tube.
However, there can still remain residual urine in the bladder even though the balloon catheter is inserted. Since the drainage consequently is not complete, this results in the risk of bacteria accumulations and accordingly a risk of infection in the bladder.
On this background, it is the object of the invention to provide a catheter for drainage of fluids in a bodily cavity of the initially mentioned kind, whereby the risk of infections in the bodily cavity, in particular a bladder wherein the catheter is inserted, is reduced.
This object is achieved, by a catheter wherein the drainage tube is further provided with one or more drain openings in the opposite end of the balloon portion between the balloon portion and the fastening of the basket member to the drainage tube.
By a catheter according to the invention, an improved drainage of fluid from a bodily cavity compared with the known catheters is achieved. By the inflation of the balloon portion which may be by means of air, water or the like, the tubular member around the balloon element is expanded and forms lamella elements as a basket. Hereby, the drain openings in the catheter are exposed not only in front of but also behind the balloon portion. Hereby, a declive drainage of the bodily cavity, preferably the bladder, is achieved and consequently infections in the bladder are avoided. By a catheter according to the invention, there is ensured a declive drainage of the bladder with the drain openings below the balloon but inside the lamellas of the tubular member. Moreover, by a catheter according to the invention, it is ensured that the wall of the bodily cavity, i.e. the bladder top, is not sucked into the drain openings in the front end of the catheter, whereby pressure wounds in the bladder wall is avoided.
In the preferred embodiment the slit tubular member is provided with at least two lamella elements, preferably three or four lamella elements. Hereby, it is ensured that the drain opening is not blocked by a contact between the drain opening and the cavity wall of the bodily cavity.
Preferably, the slit tubular member is closed at its distal end and surrounds the end portion and the balloon portion and forms a substantially conic basket when the balloon portion is inflated. Hereby, it is ensured in a simple manner that the bladder wall is not sucked into the drain opening in the front end of the catheter, so that pressure wounds in the bladder wall are avoided.
In a preferred embodiment of the invention, the tubular member is made of silicone or latex. By providing the tubular member in a flexible and elastic material, it is
ensured that the tubular member returns to the tubular shape when the balloon is deflated.
In a preferred embodiment of the invention, the drainage tube is provided with an end member in the distal end portion which is mounted at the end of the flexible drainage tube. Hereby a rounded distal end of the catheter is achieved and the risk of damaging the wall of the bodily cavity is avoided. The drainage tube is preferably made in latex, silicone or similar elastically material so that a flexible catheter in a biologically inert material is provided.
In the following, the invention is described in more detail with reference to the accompanying drawings, in which
Figure 1 shows a schematic cross-section view of a catheter according to the invention with the balloon portion inflated;
Figure 2 is an end view of same; figure 3 shows a schematic cross-section view of a catheter according to the invention with the balloon portion deflated; and Figure 4 shows the tubular member of the catheter according to the invention.
In the figures a catheter is shown which comprises a flexible drainage tube 1 with a centrally disposed flow canal 20 (see fig. 1) for removal of fluid from the catheter. The drain tube 1 is closed in the distal front end 3 of the catheter. Immediately behind the front end 3, the catheter is provided with a balloon portion 4 that surrounds the drainage tube 1. On the outside of the balloon portion 4 there is provided a thin tubular member 5, which is made in latex, silicone or the like. This tubular member 5 is fixed to the drainage tube 1 by an adhesive section 11 both in front of the balloon portion 4 and by an adhesive section 8 along the rear flange of the tube, preferably in a distance of 5 to 10 mm from the balloon portion 4. The tubular member 5 is slit with a number of longitudinal slits 10 and associated lamellas 9 (see fig. 4) that ends a few millimetres before the ends of the tubular
member 5. A separate flow canal 21 is formed in the wall of the drainage tube 1 by means of which the balloon portion 4 may be inflated (see. figs. 1 and 2) and deflated (see fig. 3) by providing an air flow or the like. Between the front end 3 and the balloon portion 4, the catheter is provided with a drain opening 2 through which there is access to the flow canal 20 of the drainage tube 1. Behind the balloon portion 4 the drainage tube 1 is also provided with one or more drain openings 7. By inflation of the balloon portion 4, the tubular member 5 creates a cone-shaped basket 6 by its lamellas 9. This results in the drain openings 2 inside this basket 6 are being exposed and thereby opened just as the drain opening 7 behind the balloon 4 is exposed and opened.
In figures 1 and 2 an embodiment is shown where the tubular member 5 is provided with four lamellas 9 that create a conic basket shape 6 in front of the balloon 4. When the balloon portion 4 is deflated, the lamellas 9 will return to the rest position since the tubular member 5 is made of an elastic material, preferably silicone or latex. This elasticity may be increased by differentiating the thickness of the tubular member so that the closed front end 12 and the opposite open end 13, which is glued or otherwise attached around the drainage tube 1, are provided with a larger thickness - preferably approx. 0.7 mm - than the thickness of the lamellas 9 - which preferably is approx. 0.25 mm. In a preferred embodiment, the tubular member 5 is glued at both ends 12, 13, so the front end 12 is glued to the distal front end 11 of the drainage tube 1 and the open end 13 is attached to the drainage tube 1 by a glued section 8. The slits 10 (see fig. 4) are in a preferred embodiment formed with a width of approx. 0.5 mm so that the build-up of tension forces in the end of the slits 10 is reduced.
The lamellas 9 may preferably be formed with a thinner thickness in the middle section. Hereby, the lamellas 9 produce less elastically resistance against inflation of the balloon portion 4.
The drainage tube 1 may in a preferred embodiment be formed with a greater inner diameter at its frontal end, i.e. the end which is surrounded by the balloon portion 4 and the tubular member 5, as the balloon portion 4 and the tubular member 5 offers a good protection of the drainage tube 1 and the requirements for thickness in the drainage tube walls can be reduced. Hereby an increased "drainage capacity" may be achieved with a given external diameter or the catheter may be produced with a smaller diameter that makes it easier to insert.
A catheter according to the invention is intented to be used as a urinary catheter for permanent use, but it is realised that the invention may also be used for draining fluids from other body cavities than the bladder. The balloon portion retains the catheter in the cavity so it does not fall out. At the same time, the drain openings are positioned so the bladder is drained from urine without bringing the drain openings in contact with the bladder wall.