Hemodialysis apparatus comprising a sterile filter
First Claim
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1. Hemodialysis apparatus comprising:
- a dialyzer divided by a membrane into two chambers, the first chamber being connected into a dialysis solution path and a second chamber into a blood path, the dialysis solution path comprising;
a supply line which extends from a means for preparing dialysis solution to the dialyzer and into which a first shutoff member is connected and a second exit line which extends from the dialyzer to a discharge and into which a second shutoff member is connected,a pump for conveying the dialysis solution in the dialysis solution path,an ultrafiltration means provided between the shutoff members in the dialysis solution path,a bypass line which connects the supply line to the exit line of the dialysis solution path and into which a bypass valve is connected, anda sterile filter (38) which is divided by a germ-retaining membrane into a first filter chamber (42) having an inlet (46) and an outlet (48) and a second filter chamber (44), with a first portion of the supply line of the dialysis solution to the first filter chamber of a sterile filter and a second portion of the supply line to the dialysis solution from the second filter chamber of the sterile filter to the dialyzer, wherein the outlet (48) of the first filter chamber (42) of the sterile filter (38) is connected to the bypass line (54) leading to the exit line (24).
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Abstract
A hemodialysis apparatus includes a sterile filter whose outlet, which is usually closed, is connected to a line leading to a discharge outlet in wherein a bypass valve is employed which can be opened at predetermined intervals both during treatment and during flushing operations. The sterile filter has a primary chamber and a secondary chamber. When the bypass valve is opened during treatment, dialysis solution flows out of the primary chamber of the sterile filter and flushes the pyrogens and particles disposed on the membranes of the filter into the discharge. No sterilizating filtration of the dialysis solution takes place through the pores of the membrane because the flow resistance present in the adjoining dialyzer, in conjunction with a degree of clogging of the pores, prevents such a flow. A ventilation means may be provided whereby the bypass circuit of the sterile filter can be ventilated. The bypass circuit may also be employed for a pressure retaining test.
128 Citations
10 Claims
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1. Hemodialysis apparatus comprising:
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a dialyzer divided by a membrane into two chambers, the first chamber being connected into a dialysis solution path and a second chamber into a blood path, the dialysis solution path comprising; a supply line which extends from a means for preparing dialysis solution to the dialyzer and into which a first shutoff member is connected and a second exit line which extends from the dialyzer to a discharge and into which a second shutoff member is connected, a pump for conveying the dialysis solution in the dialysis solution path, an ultrafiltration means provided between the shutoff members in the dialysis solution path, a bypass line which connects the supply line to the exit line of the dialysis solution path and into which a bypass valve is connected, and a sterile filter (38) which is divided by a germ-retaining membrane into a first filter chamber (42) having an inlet (46) and an outlet (48) and a second filter chamber (44), with a first portion of the supply line of the dialysis solution to the first filter chamber of a sterile filter and a second portion of the supply line to the dialysis solution from the second filter chamber of the sterile filter to the dialyzer, wherein the outlet (48) of the first filter chamber (42) of the sterile filter (38) is connected to the bypass line (54) leading to the exit line (24). - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A method for cleaning a sterile filter (38) of a hemodialysis apparatus, said hemodialysis apparatus comprising a dialyzer divided by a membrane into two chambers, the first chamber being connected into a dialysis solution path and a second chamber into a blood path, the dialysis solution path comprising:
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a supply line which extends from a means for preparing dialysis solution to the dialyzer and into which a first shutoff member is connected and an exit line which extends from the dialyzer to the discharge and onto which a second shutoff member is connected, a pump for conveying the dialysis solution in the dialysis solution path, an ultrafiltration means provided between the shutoff members in the dialysis solution path, a bypass line which connects the supply line to the exit line of the dialysis solution path and into which a bypass valve is connected, and a sterile filter (38) which is divided by a germ-retaining membrane into a first filter chamber (42) and a second filter chamber (44), with a first portion of the supply line of the dialysis solution to the first filter chamber of the sterile filter and a second portion of the supply line of the dialysis solution from the second filter chamber of the sterile filter to the dialyzer, wherein an outlet (48) of the first filter chamber (42) of the sterile filter (38) is connected to a bypass line (54) leading to an exit line (24), said method comprising the steps of; opening the bypass valve (58) at predetermined intervals of time during dialysis by means of a control unit (82) in order to bypass said sterile filter; and closing the bypass valve (58) at predetermined intervals of time during dialysis by means of the control unit 82.
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9. A method for checking a sterile filter (38) of a hemodialysis apparatus, the hemodialysis apparatus comprising a dialyzer divided by a membrane into two chambers, the first chamber being connected into a dialysis solution path and a second chamber into a blood path, the dialysis solution path comprising:
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a supply line which extends from a means for preparing dialysis solution to the dialyzer and into which a first shutoff member is connected and a second exit line which extends from the dialyzer to a discharge and into which a second shutoff member is connected, a pump for conveying the dialysis solution in the dialysis solution path, an ultrafiltration means provided between the shutoff members in the dialysis solution path, a bypass line which connects the supply line to the exit line dialysis solution path and into which a bypass valve is connected, and a sterile filter (38) which is divided by a germ-retaining membrane into a first filter chamber (42) having an outlet (48) and a second filter chamber (44), with a first portion of the supply line of the dialysis solution to the first filter chamber of a sterile filter and a second portion of the supply line to the dialysis solution from the second filter chamber of the sterile filter to the dialyzer, wherein the outlet (48) of the first filter chamber (42) of the sterile filter (38) is connected to the bypass line (54) leading to the exit line (24), wherein a ventilation means (60) is connected into the bypass line (54) between the bypass valve (58) in the first filter chamber (42) of the sterile filter (38), wherein the ventilation means (60) comprises a ventilation valve (66), a housing (62) which is connected into the bypass line (54) and a microporous hydrophobic membrane (68) which divides the interior into a first chamber (70) in flow communication with a tube connecting piece (64) leading from the housing and a second chamber (72) in flow communication with the bypass line (54), wherein the end of the tube connecting piece (64) is connected to the ventilation valve (66), wherein the shutoff means are formed as balance chamber (32) and by a control unit (82) which is connected via a first control line (84) to the balance chamber (32), via a fourth control line (90) to the ventilation valve (66), via a fifth control line (92) to an ultrafiltrate pump (76), via a sixth control line (84) to the bypass valve (58), via a seventh control line (96) to the dialysis solution pump (78) and via a signal line (98) to the manometer (80), said method comprising the steps of; removing the dialyzer (12), closing the supply (22) and the exit line (24) with a connector (100), deactivating the dialysis solution pump (78) by means of the control unit (82), closing the balance (32) or the shut off valves (34 and
36) by means of the control unit (82),opening the ventilation (60) with respect to the atmosphere by means of the control unit (82), setting the ultrafiltrate pump (76) in operation until a predetermined pressure value is reported by the manometer (80) by means of the control unit (82), thereafter setting the ultrafiltrate pump (76) out of operation by means of the control unit (82), monitoring the pressure value signals furnished by a manometer (80) for a predetermined period of time by means of the control unit (82), and subsequently indicating the intactness of the sterile filter (38) by means of said control unit (82).
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10. A method for checking a sterile filter (38) of a hemodialysis apparatus, the hemodialysis apparatus comprising a dialyzer divided by a membrane into two chambers, the first chamber being connected into a dialysis solution path and a second chamber into a blood path, the dialysis solution path comprising:
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a supply line which extends from a means for preparing dialysis solution to the dialyzer and into which a first shutoff member is connected and a second exit line which extends from the dialyzer to a discharge and into which a second shutoff member is connected, a pump for conveying the dialysis solution in the dialysis solution path, an ultrafiltration means provided between the shutoff members in the dialysis solution path, a bypass line which connects the supply line to the exit line of the dialysis solution path and into which a bypass valve is connected, and a sterile filter (38) which is divided by a germ-retaining membrane into a first filter chamber (42) having an inlet (46) and an outlet (48) and a second filter chamber (44), with a first portion of the supply line of the dialysis solution to the first filter chamber of a sterile filter and a second portion of the supply line to the dialysis solution from the second filter chamber of the sterile filter to the dialyzer, wherein the outlet (48) of the first filter chamber (42) of the sterile filter (38) is connected to the bypass line (54) leading to the exit line (24), wherein a ventilation means (60) is connected into the bypass line (54) between the bypass valve (58) in the first filter chamber (42) of the sterile filter (38), wherein the ventilation means (60) comprises a ventilation valve (66), a housing (62) which is connected into the bypass line (54) and a microporous hydrophobic membrane (68) which divides the interior into a first chamber (70) in flow communication with a tube connecting piece (64) leading from the housing and a second chamber (72) in flow communication with the bypass line (54), wherein the end of the tube connecting piece (64) is connected to the ventilation valve (66), wherein the shutoff means are formed by shutoff valves (36 and
34) and by a control unit (82) which is connected via second and third control lines (86 and
88) to the first and second shutoff valves (36 and
34), via a fourth control line (90) to the ventilation valve (66), via a fifth control line (92) to an ultrafiltrate pump (76), via a sixth control line (84) to the bypass valve (58), via a seventh control line (96) to the dialysis solution pump (78) and via a signal line (98) to the manometer (80), said method comprising the steps of;removing the dialyzer (12), closing the supply (22) and the exit line (24) with a connector (100), deactivating the dialysis solution pump (78) by means of the control unit (82), closing the balance (32) or the shut off valves (34 and
36) by means of the control unit (82),opening the ventilation (60) with respect to the atmosphere by means of the control unit (82), setting the ultrafiltrate pump (76) in operation until a predetermined pressure value is reported by the manometer (80) by means of the control unit (82), thereafter setting the ultrafiltrate pump (76) out of operation by means of the control unit (82), monitoring the pressure value signals furnished by a manometer (80) for a predetermined period of time by means of the control unit (82), and subsequently indicating the intactness of the sterile filter (38) by means of said control unit (82).
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Specification
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Current AssigneeFresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
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Original AssigneeFresenius AG (Fresenius SE & Co. KGaA)
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InventorsPolaschegg, Hans-Dietrich
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Primary Examiner(s)Jones, W. Gary
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Application NumberUS07/128,131Time in Patent Office544 DaysField of Search210/741, 210/791, 210/806, 210/90, 210/99, 210/120, 210/130, 210/134, 210/254, 210/257.2, 210/258, 210/259, 210/295, 210/321.69, 210/321.72-321.81 , 210/321.84, 210/409, 210/416.1, 210/420, 210/433.1, 210/472, 73/38, 73/40US Class Current210/646CPC Class CodesA61M 1/16 with membranesA61M 1/1601 Control or regulationA61M 1/165 with a dialyser bypass on t...A61M 1/1672 using membrane filters, e.g...A61M 2205/3331 Pressure; FlowA61M 2205/50 with microprocessors or com...A61M 2205/705 Testing of filters for leak...A61M 2205/7554 with means for unclogging o...A61M 2205/7563 with means preventing clogg...
