Peritoneal dialysis system.

SPECIFICATION

0001The invention refers to a system of tubes for the ex­change of liquids (bring in and out) between the peritoneal cavity and two bags (one of the bags been filled with spe­cial liquid for the peritoneal cleansing, while the other bag is empty) under aseptic conditions, which are assured through an external infusion of antiseptic.

0002Such systems for exchanging liquids are already in ex­istence combined with one (single systems) or two (double systems) bags. The main disadvantage of the existing systems is the high frequency of peritonitis.

0003In order to reduce the frequency of peritonitis an an­tiseptic is used in or out of the tubes. The use of an an­tiseptic in the tubes is made as follows: <ul id="ul0001" list-style="none"><li>a) By suction or infusion of the antiseptic from one end of the tubes of the bags. In this case, free tubes "Y" shaped are used. The vertical branch of the "Y" is connected to the peritoneal catheter and the antiseptic is infused or sucked through one (of the two free) lateral branches of the "Y". Then follows the connection of the bags of the peritoneal cleansing at the ends of the lateral branches of the "Y". A characteristic of the kinetics of the antiseptic is its movement from the end of one of its lateral branches, to the end of its other lateral branch, while the vertical branch of the "Y" is by-passed.</li><li>b) With the insertion of two spikes (usually metallic) in a plastic cartridge full of antiseptic. In this cas also, transfer tubes of liquids "Y" shaped or slightly modified "T" shaped are used. One of the spikes is at the end of the vertical branch of the "Y", while the other spike is fitted to the end of the peritoneal catheter or to the extension tube. The bags of the peritoneal cleansing are fitted to the ends of the lateral branches of the "Y". The two spikes enter the cartridge with the antiseptic just before the exchange of liquids. The whole procedure of the introduction and ab­duction of the solutions is carried out through the cartridge of the antiseptic, which is inserted between the two spikes. A characteristic of the kinetics of the antisep­tic is the modification of its kinetic condition: while not moving (introduced beforehand in the cartridge) is carried away with turbulent flow to the empty bag. In other words, the use of the antiseptic is done through passive immersion of the spikes in a cup (cartridge) containing the antisep­tic.</li></ul>

0004The advantage of this invention is the dynamic infusion (by syringe) of the antiseptic just before the exchange of liquids of the peritoneal cleansing, by means of a special tubular float (Π) installed in the system of tubes for liq­uid exchange. For the system F, the infusion of the antisep­tic is assured on both sides of the conection point (ε) of the tubes (σ) of the bags with the tube (γ) extending the peritoneal catheter.

0005The system F is organized round the "T" shaped conver­gence point of the tubes of the bags. At both ends of the horizontal branch of the T (head-κ- of the T), the system bears the bags of the peritoneal cleansing (one full with liquid and one empty). The free end of the vertical branch (branch-σ- of the T), has a screw (S1), connected with a corresponding screw (S2), of the tube (γ) of the peritoneal catheter. In the middle of the T head, there is an infusion aperture (ϑ) of the antiseptic. The tubular float starts from the aperture of infusion (ϑ) of the T head (Fig. 1), is borne within the T branch and throughout the course of the branch and projects from the connecting screw by 2-3 cm. Just before the exchange of liquids, the free end of the tubular float enters the tube extending the peritoneal catheter and the screw (S1) of the T is connected with the corresponding screw (S2) of the tube extending the peritoneal catheter. Thus, just before the infusion of the antiseptic, the tubular float (Π) is located within the extending tube of the peritoneal catheter, while its free end lies between the closed clamp C1 (Fig. 1) of the tube extending the peritoneal catheter and the point of connection "ε" (=bolding point of the system F, with the tube extending the peritoneal catheter).

0006After connecting the system F, with the tube extending the peritoneal catheter, the infusion of the antiseptic is made through the gate of infusion (ϑ) of the head "T" with the use of a common syringe. Due to the fact that the aperture of infusion communicates hermetically only with the tubular float (Π), the antiseptic flows in the tubular float and sprays the area of the tubes, on both sides of the cor­responding point (ε). Thus, after this area is filled with antiseptic, the antiseptic flows backward (in the branch-σ- of the "T", but outside the tubular float -Π-) to the empty bag. The tubes are washed out of the antiseptic during the evacuation of the peritoneal cavity to the empty bag of sys­tem F. Thereafter follows the filling of the peritoneal cavity with the liquid of the full bag of system F.

0007Figure 1 shows a section of point "T" together with the float of infusion of the antiseptic which projects from the bolt connection by 2-3 cm. Figure 2 shows the connection of the system F with the tube extension (γ) of the peritoneal catheter of a patient. Figure 2 shows the location of the branch of "T" (indicated with "σ") as well as the head of the "T" (indicated with "κ") after connection of the system F with the tube extension of the peritoneal catheter of a patient. Figure 3 shows the successive exchange phases of liquids and the infusion of antiseptic during the operation of system F. The bag "Π" in figure 3 presents the peritoneal cavity of a patient. Thus, figure 3.1 shows the way the float of system F extends from the branch of the "T", just before the connection of the system F with the tube extension of the peritoneal catheter. Figure 3.2 shows the infusion of an­tiseptic in system F from the aperture of infusion of the "T", as well as the area of the initial distribution of the antiseptic between the clamps of the various tubes (C1, C2, C3). Figure 3.3 shows the washing out of the tubes and of the "T" during the evacuation of the liquid which is found in the bag "Π". Figure 3.4 shows the filling of the bag "Π" with the contents of the bag A.

0008A description is given below of one way of application of system F in relation to the drawings. System F is composed of point "T" (figure 1), which is the convergence point of two tubes starting from the two bags (A and B, figure 2): one bag full of liquid of peritoneal cleansing (A, figure 2) and one empty bag (B, figure 2). At the connection of the branch of the "T" (figures 1 and 2), with the tube (γ, figure 2) extension of the peritoneal catheter, the tubular float of "T" (figure 1) enters the pipe of the tube exten­sion of the peritoneal catheter by about 2-3 cm (figure 2) protruding out of the connecting point "ε" (figure 2). Immediately after the above follow: 1) Infusion of the antiseptic through the aperture of infusion (ϑ) of the "T" (figure 3.2). Thus, the microbes which probably entered the system of tubes upon connection are exterminated. 2) Opening of the clamp (C1) of the tube of the bag "Π", resulting in the supply of its contents to the bag "B" (figure 3.3) Thus, a wash out of system F is achieved by the antiseptic. 3) Closing of clamp (C2) of the tube of the bag "B" and opening of the corresponding clamp (C3) of the tube of the bag "A" resulting in the flow of the contents of the bag "A" to the bag "Π". In this way the bag "Π" is filled with fresh solution (figure 3.4). After these manipulations, the system F is dis­connected and rejected.