Abstract:
Catheter system consisting of a sleeve, a catheter and a membrane partially arranged in the sleeve, which can be fixed in a skin passage unit in such a way that the catheter protrudes from the skin passage unit towards the interior of the body, wherein the individual components of the catheter system are inseparably connected to one another.

Description:
This application is a continuation of U.S. patent application Ser. No. 09/048,756, filed Mar. 26, 1998, now issued as U.S. Pat. No. 6,071,265, issued on Jun. 6, 2000, which is hereby incorporated herein by reference. 
    
    
     PRIORITY CLAIM 
     This application claims priority of Swiss patent application 1997 0727/97, filed Mar. 26, 1997, which hereby fully is incorporated herein by reference. 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The invention refers to a catheter system consisting of a sleeve, a catheter and a membrane partially arranged in the sleeve, which can be fixed in a skin passage unit in such a way that the catheter protrudes from the skin passage unit towards the interior of the body, wherein the individual components of the catheter system are inseparably connected to each other. 
     2. Description of the Related Art 
     Single and multi-lumen catheters made from extruded plastic and cut to a standard length are known. The catheter tip, arranged at the release site of the drug in the human or animal body, is rounded to such an extent that, as far as possible, the hazard of damaging the vessels or the intestinal skin in the abdominal cavity is avoided. The catheter is purposely produced by the manufacturer in a size exceeding the required length so that the catheter can be shortened to the required length during an operation by cutting away the superfluous part. The catheter end created by the cutting process is subsequently formed into a funnel shape to allow a couple with an infusion set inside a port chamber. 
     U.S. Pat. No. 5,306,255 and European patent EP-B-0 302 076 describe subcutaneous and percutaneous port bodies. These port bodies serve to connect an infusion hose situated outside of the human or animal body to a port catheter situated inside the human or animal body. External embodiments of such port bodies are sufficiently described in the aforementioned patent specifications and we therefore refer to these specifications at this point. 
     European patent EP-B-0 398 950 describes the internal design of a port body, the port chamber. The port chamber consists of a membrane chamber with two opposing apertures, a membrane made from a flexible material and arranged between these two apertures, containing a connecting channel in its center between the two apertures of the chamber. One aperture serves to accommodate an external infusion hose while a post catheter is located at the other aperture. 
     In the known devices, the port catheter is connected to the port chamber in such a way that after one end of the catheter has been formed into a funnel shape, the rounded end of the port catheter tip is pushed through the port until the funnel-shaped part of the port catheter wedges itself in the respective aperture of the port body. 
     The disadvantage of the known systems is that for the mechanical finishing of the catheter end, resulting in the said funnel shape, a special device is needed whose operation requires prior training. The device must be available in every hospital, resulting in purchasing, maintenance, cleaning and sterilization costs. The finishing of the catheter end also takes up a certain time during the operation. Furthermore, the functionality after the reshaping of the catheter end can only be checked visually in the operating theater. 
     After having been prepared as specified above, the catheter end must be pushed through the port body into its end position. This requires asserting some force directly on the previously prepared catheter end. As a result the catheter end may be damaged, soiled or incorrectly assembled, causing the drug channel to be blocked. A further disadvantage is that the functionality can only be checked after its installation. 
     SUMMARY OF THE INVENTION 
     The invention aims to remedy these disadvantages. The object of the invention is to provide a catheter system for administering drugs that neither requires nor permits a mechanical finishing of a catheter end by the operator, that is simple and secure to handle and allows a quick implantation. The function of the catheter system must also be tested outside of the port and before its implantation. 
     The invention solves the set task with a catheter system consisting of a sleeve, a catheter and a membrane partially arranged in the sleeve, which can be fixed in a skin passage unit in such a way that the catheter protrudes from the skin passage unit towards the interior of the body, wherein the individual components of the catheter system are inseparably connected to each other. 
     The invention offers the principle advantages that a mechanical finishing of the catheter by the operator during the operation is neither required nor possible, and that it allows a simple and rapid handling of the catheter system fixing inside the port body. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     A preferred embodiment of the invention is shown in the figures, in which: 
     FIG. 1 represents a port body; and 
     FIG. 2 represents a catheter system according to the invention. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Hereinafter the term “inside” will mean “within the human or animal body” and “outside” will mean “outside of the human or animal body.” 
     As shown in FIGS. 1 and 2, a closing sleeve  4  of a catheter system  1  is inserted into a port body  111  which alternatively may be called a skin passage unit the port body  111  consists of a hollow cylindrical sleeve portion  114  and a radial anchoring plate  113  arranged on the sleeve. The port body  111  contains two opposing apertures  131 ,  132 . An aperture  131  facing towards the outside corresponds to the internal diameter of the hollow cylindrical sleeve portion  114 . The second aperture  132  is located at the end of port body  111  and closes off in a conical shape. 
     As shown in FIG. 2, the catheter system  1  consists of a hollow cylindrical closing sleeve  4 , a cylinder-shaped membrane  8  partially arranged in the closing sleeve  4  and a hose-shaped catheter  9 . 
     The catheter  9  is preferably made from a biocompatible plastic and may be divided into three sections: a catheter head  10 , a hose-shaped interim section  15  and a rounded end section  11 . A continuous drug channel  13  runs through the inside of the catheter  9 . 
     The outer diameter of the catheter head  10  is larger than that of the hose-shaped interim section  15 . The transition between the catheter head  10  and the interim section  15  is preferably designed as steep. 
     The inner part of the catheter head  10  is funnel-shaped, ending in the drug channel  13 . 
     The closing sleeve  4  has a cylindrical structure and contains two opposing apertures  3 ,  33 . The aperture  3 , facing towards the outside, is located in the center of a cover  2 , providing the external seal of the closing sleeve  4 . The second aperture  33 , facing towards the inside, corresponds to the internal diameter of the closing sleeve  4 . 
     The membrane  8  fills the closing sleeve  4  and overlaps the aperture  33  in such a way that it closes off the closing sleeve  4  in a conical shape  14 . The membrane is preferably produced from a flexible plastic such as silicone or polyurethane. The center of the membrane contains a self-closing connecting channel  7 . An inlet aperture  7   a  of the connecting channel  7 , facing towards the outside, is located at the aperture  3  of the cover  2  while an outlet aperture  7   b  of the connecting channel  7  is located inside the membrane. The catheter head  10  is arranged at the outlet opening  7   b  so that the closing sleeve  4 , the membrane  8  and the catheter  9  form one integral unit. 
     The closing sleeve  4  surrounds the membrane  8  containing the catheter head  10  in such a way that the membrane  8  and the catheter head  10  are centrically held together between the cover and the internal wall  18  of the closing sleeve with a defined initial pressure. 
     The external casing  19  of the closing sleeve  4  contains up to three closing cams of closing elements so that the closing sleeve  4  and thus the entire catheter system  1  can be installed in a respectively designed cylindrical sleeve portion  114  of port body  111 . The diameter of the cover  2  of the closing sleeve  4  corresponds to the external diameter of the sleeve portion  114  of port body  111 . A closing seal  17  arranged between the cover  2  and the sleeve portion  114  of port body  111  ensures that no dirt or bacteria can enter between the port housing  114  and the closing sleeve  4 . 
     The closing sleeve  4  is preferably produced from injection-molded plastic. This allows a skin-like color to already be applied to the closing sleeve  4  or at least the cover  2  during manufacture, making the externally visible cover  1  less noticeable. 
     The requirement for a correct catheter length will be met by producing the catheter  9  in various lengths. 
     The catheter system  2  according to the invention is installed in a port body  111  in such a way that the catheter  9  is first pushed through the respective opening  132  of the port housing  114 . As soon as the conically shaped section  14  of the membrane  8  pushes against the internal wall of the port housing  114 , the locking cams  5  arranged on the external casing  19  of the closing sleeve  4  are anchored in a respective recess or counter elements of the internal casing of the port sleeve portion  114  of the port body  111  by a slight rotation of the closing sleeve  4 . The hexagonal socket shape of the cover aperture  3  allows the slight rotation of the closing sleeve  4 . Naturally also other key forms are feasible. 
     To release drugs from a container into a human or animal body, an infusion hose is pushed from the outside through the opening  3  of the lid  2  and through the connecting channel  7  to the catheter head  10 . In order to secure the infusion hose in this connection, the end of the infusion hose can be designed in such a way that it is retained in a respective recess  16  between the membrane  8  and the catheter head  10 . 
     Once the infusion hose is removed, the aperture  3  can be closed with a cover.