MXPA98010578A - Disposable hemodiafiltration set - Google Patents

Abstract

A sterile disposable hemodiafiltration set to be connected to a dialysis machine comprising a dialyzer (14) with an extracorporeal blood path (19) and a supplying dialysis liquid supply line (10) which can be connected to the dialyzer. The hemodiafiltration set comprises a sterilized unit consisting of a hose connection (28) with a sterile filter (27) therein, said hose connection being arranged for connection at one end thereof to the extracorporeal path (19) via a separate pump (29;30) and being provided with a three-way joint (22) at the other end thereof for connection of said latter end between the dialysis liquid supply line (10) and the dialyzer (14).

Description

DISPOSABLE HEMODY FILM EQUIPMENT DESCRIPTION OF THE INVENTION The invention relates to a disposable, sterile hemodiafiltration device for being connected to a dialysis machine comprising a dialyzer with an extracorporeal blood path and a dialysis liquid supply line, which can be connected to the dialyzer. In conventional hemodialysis treatment impurities are separated from the blood in the dialyzer by diffusion, while the separation of the impurities in the hemodiafiltration treatment is effected by diffusion and by convection dialysis of the liquid that is supplied as a liquid substitute for blood in the extracorporeal way. Hemodiafiltration treatment is preferred because larger molecules are also separated from the blood; the larger molecules can not be separated to the same degree when the dialysis treatment includes diffusion only. The dialysis fluid that is to be supplied to the blood as the substitute liquid is of course subject to ref. 28986 higher demands for sterility than the dialysis fluid that passes through the dialyzer and, therefore, undergoes additional filtration before being delivered to the blood line. U.S. Patent No. 4,702,829 describes a machine for hemodiafiltration, wherein the dialysis liquid to be used as a substitute liquid is passed through two sterile filters provided in the machine, which are not used to filter the liquid of dialysis that is going to be delivered to the dialyzer. Having passed the sterile filters the substitute fluid is passed through a disposable linear section that includes a microfilter and that is connected to the blood path either on the exit side of the dialyzer (post t-dilution) or on the side dialyzer inlet (pre-dilution). In the dialysis machine designed for hemodiafiltration according to US Patent No. 4,702,829 as in other dialysis machines on the market, designed for hemodiafiltration, a separate outlet is provided on the machine for the substitute liquid to which a disposable equipment that forms part of the hemodiafiltration circuit, in order to establish or adjust the dialysis machine for the treatment of hemodiafiltration, said circuit being partially permanent and exposed to disinfection between the treatments in the dialysis machine, specially constructed for the hemodiafiltration. Taking into account that the dialyzer is always connected to the dialysis machine by means of hoses by quick connectors (Hansen type connectors) the objective of the invention is to provide a disposable equipment that can be easily connected to any dialysis machine built for hemodialysis and that has ultrafiltration control, but in no way constructed or prepared for hemodiafiltration treatment, in order to allow the dialysis fluid to be delivered to the dialyzer, is partially drained and after filtration in a sterile microfilter, included in Disposable equipment is supplied to the blood line. In order to achieve this objective the disposable equipment of the type referred to above has obtained, according to the invention, the characterizing features of claim 1. By this arrangement it is possible to make the dialysis fluid available on any dialysis machine built for hemodialysis , and having ultrafiltration control simply by disconnecting the dialyzer from the dialysis fluid and the supply line, and interconnecting the three-way junction between the supply line and the dialyzer, the dialysis fluid being supplied after the filtration in the sterile filter, by means of the hose connection to the blood path on one side or the other of the dialyzer (pre-dilution or post-dilution), respectively). According to a preferred embodiment of the invention, the sterile filter is combined with the three-way connection and forms an integral unit with it. In order to explain the invention in more detail, reference is made to the accompanying drawings which describe an illustrative embodiment and wherein: Figure 1 is a diagram of a dialysis machine constructed for hemodialysis and having ultrafiltration control with the disposable equipment according to the invention in one embodiment thereof, Figure 2 is a corresponding diagram of a dialysis machine with disposable equipment of a second embodiment, Figure 3 is a perspective view of a three-way union that it forms part of the disposable equipment, and Figure 4 is a perspective view of a three-way union made integral with a sterile filter. In Figure 1 there is shown a dialysis machine built only for hemodialysis and having ultrafiltration control indicated by a block 11. The machine supplies the high quality dialysis liquid in a line 10 which is connected to the inlet 13 of dialysis fluid from a dialyzer. The dialysis fluid outlet 15 thereof is connected to an outlet line 16. An extracorporeal blood line 19 extends through the dialyzer 14 and includes a drip chamber 20. In order to allow treatment by hemodiafiltration by using the dialysis machine with the described system, the invention provides sterile disposable hose equipment located within the structure or frame 21 in dashed lines. This disposable hose assembly comprises a three-way joint 22 of the type described in Figure 3. The three-way joint comprises a plug 23 with quick connectors at both ends thereof, called Hansen connectors, a connector 24 of which is a male connector to be connected to the supply line 20, and the other connector 25 which is a female connector to be connected to the inlet 13 for the dialysis fluid of the dialyzer 14. The inlet is provided with a male connector and the supply line with a female connector, and in the conventional treatment of hemodialysis these two connectors are interconnected as indicated by a dashed dotted line, but when a haemodiafiltration treatment is going to take place, the connectors are disconnected and the plug 23 of the three-way union is interconnected between them. The three-way junction also has a branch plug 26 and is connected in this socket with a sterile filter 27 which is connected to one end of a hose 28. The hose equipment is distributed in a sterile package. After the three-way junction has been connected as explained above, the other end of the hose 28 is connected to the drip chamber 20 and the hose is placed around the rotor of a peristaltic pump 29. From the flow of dialysis fluid supplied to the dialyzer, a flow determined by the peristaltic pump is thus drained, and after filtration in the microfilter, this flow is supplied to the drip chamber to be supplied to the blood in the extracorporeal blood path during a hemodiafiltration treatment. The supply may take place elsewhere either for post-dilution, as shown, or for pre-dilution. In a preferred development of the invention the sterile filter 27 is integrated with the three-way junction 22 as shown in Figure 4. The filter can rather be integrated with yet another element in the circuit for the substitute flow, for example with the drip chamber 20. In the embodiment according to Figure 2, the peristaltic pump is replaced by a pump, indicated by a symbol 30, which is combined with the unit formed by the three-way junction 22 and the sterile filter 27. The pump is connected to a turbine which is driven by the flow of the dialysis fluid to the dialyzer., to pump the substitute fluid to the extracorporeal way by means of the sterile filter. In summary, the invention provides the possibility of effecting, by means of a controlled dialysis machine, ultrafiltration, constructed for hemodialysis only and not constructed or prepared for the treatment of haemodiafiltration, of a hemodiafiltration treatment without making any modification in the machine or in the same program. In other words, no special construction machine is required for hemodiafiltration.

It is noted that in relation to this date, the best method known by the applicant to carry out the aforementioned invention, is the conventional one for the manufacture of the objects to which it relates.

Having described the invention as above, property is claimed as contained in the following:

Claims (5)

1. A sterile, disposable hemodiafiltration device for being connected to a dialysis machine comprising a dialyzer, with an extracorporeal blood route and a dialysis fluid supply line, which can be connected to the dialyzer, characterized by the hemodiafiltration device because it comprises a sterilized unit consisting of a hose connection with a sterile filter provided therein, said hose connection being arranged for connection at one end thereof to the extracorporeal way by means of a separate pump, and which is provided with a three-way junction at the other end of the same, for the connection of the latter and between the supply line for the dialysis fluid and the dialysis machine.

2. The haemodiafiltration device according to claim 1, characterized in that the three-way junction is provided with quick connectors, for connection to the quick coupling connectors on the dialysis liquid supply line and the dialyzer, respectively.

3. The haemodiafiltration device according to claim 1 or 2, characterized in that the three-way junction and the sterile filter are integrated to form a unit.

4. The haemodiafiltration device according to any one of claims 1 to 3, characterized in that the hose connection forms a liquid conducting element in a peristaltic pump.

5. The haemodiafiltration device according to any one of claims 1 to 3, characterized in that the pump is integrated with the three-way connection to form a unit with this.