DE2820256A1 - SINGLE-PIECE HYDRAULIC CIRCUIT UNIT FOR A BLOOD DIALYZER - Google Patents

Description

2820256 Henkel, Kern, Feiler & Hänzel Patent Attorneys

Möhlstrasse 37 Baxter Travenol Laboratories, Ine. D-8000 Munich 80

Dee rf ie ld, 111. V. St. A. Tel .: 089 / 982085-87

Telex: 05 29 802 hnkl d

Telegrams: ellipsoid

May 9, 1978

One-piece hydraulic circuit unit for a blood dialyzer

The invention relates to a one-piece hydraulic circuit unit for a blood dialyzer.

Hemodialysis devices for so-called. "Artificial kidneys" included usually a supported, semi-permeable membrane made of a cellular glass-like material, which is so in a Housing is arranged to have a blood flow path on one side and a dialysis solution flow path along the other side for a diffusion exchange between the blood and the dialysis solution taking place across the membrane without direct mixing of the two liquids.

There are a considerable number in the actual hemodialysis process of treatment steps necessary during the process in which the blood is fed to the hemodialyzer and from there to the Return to the patient is taken. With the currently usual arterial and vein (line) sets with which the blood taken from the patient, passed to the dialyzer and back to the

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Patient is returned, bubble traps, filters, sterile access points for injection needles and access points or taps for pressure switch devices can all be in These kits are comprised primarily of flexible, blood-compatible plastic tubing. The current one Dialysis technology therefore requires two different and separate, long hose sets, namely the - based on the blood flow - the set of arteries located upstream of the dialyzer and the set of veins located downstream thereof.

To initiate a dialysis process, a dialyzer must therefore be selected, and the assistant must also be separated Procure a set of arteries and a set of veins from it. The packaging of all these devices must be opened, and the individual devices must be connected and put together and other auxiliary devices are also switched on into the system. These operations require one highly skilled technician who makes a considerable number of connections between the sets or devices and the Dialyzer must produce error-free and error-free.

The object of the invention is thus to create a one-piece hydraulic circuit unit which has numerous functions the arterial inlet and outlet sets and auxiliary equipment. This unit should, if desired be connectable to the dialyzer itself during manufacture. Setting up the dialysis machine prior to use is done This is very much simplified in this way, and in particular many of the connections that are made by the technician on Place of use would have to be produced, which in turn reduces the possibility of errors and contamination of the System during assembly and connection can be avoided. In addition, the device according to the invention should be compact and be simplified so that they represent a substantial saving

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provides otherwise required space around the patient's bed during the dialysis process.

This task is performed with a one-piece hydraulic circuit unit for use in a blood dialyzer according to the invention solved by a rigid or rigid, one-piece part, the three spaced apart chambers, one in communication with the first chamber and connectable to a venous line leading to a patient first inlet and one communicating with the first chamber and connectable to the outlet of a blood dialyzer having a second inlet, the second chamber having a third, connectable to an arterial line of the patient Permit is in communication and also communicates with a fourth permit which is connected to a blood conveying or pump line is connectable, and the third chamber with a fifth, connectable to the blood pump line inlet and with one communicates sixth, with the inlet of the blood dialyzer connectable admission.

In the special embodiment of the to be described Invention, the flow of blood from the patient's artery enters the second chamber, being in the top of the chamber collect any bubbles, for example, at a puncture or. Injection point in the line for flow monitoring can penetrate. The fourth outlet is located essentially at the bottom of the chamber, whereby the Bubble separation is favored. The blood oozes out the fourth admission via a pump line, which is in a conventional roller pump device for conveying the blood flow can be incorporated by the device.

The blood flowing through the pump or delivery line enters the fifth inlet and the third chamber in which

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an additional bubble separation function takes place around the Safely prevent (gas) bubbles from entering the dialyzer. The sixth admission, the one from the bottom of the third evacuation goes off, is connected to a line, which in turn leads to the blood inlet of the dialyzer.

After passing through the dialyzer, the blood emerges from the outlet, which in turn is connected to the second admission of the first chamber is connected. The blood flowing into the first chamber then generally flows through an air exclusion filter, to prevent blood from infusing into the patient. The blood then flows through the first admission of the first chamber, which is in communication with a line connected to the venous system of the patient.

As a result of this training, the highly desirable bubble trapping function, plus a blood filtering function, by the one-piece hydraulic circuit unit according to the invention can be guaranteed.

In addition, other injection access sites, e.g. for the removal of air, as well as a connection point for the measurement of the chamber pressure. Furthermore, if desired a saline infusion line and a heparin line additionally be connected to the device.

The following are preferred embodiments of the invention explained in more detail with reference to the accompanying drawing. Show it:

Fig. 1 is a perspective view of a tinetückigen Hydraulikkreieeinheit according to the invention, the TiN ■ al angeschloeitn is a hollow fiber dialyzer, and · on the other various additives or ΗΰΓβleitungen,

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9 Fig. 2 shows a section along the line 2-2 in Fig. 1,

3 shows a sectional view, similar to FIG. 2, of a modified form of advice guidance of the device according to the invention,

Fig. 4 shows a detail showing a section through a modified one Pressure measuring element and

5 shows a section along the line 5-5 in FIG. 1, on an enlarged scale.

The hydraulic circuit unit 10 shown in the drawing consists of a rigid, flat plastic plate in which Chambers 12, 14 and 16 are formed.

Referring to Figure 2, the unit 10 comprises a flat lower plastic plate 18, in which the chambers and the necessary permits are designed as recesses. The plate 18 can be covered with a cover element 20 to close the recesses.

According to FIG. 3, both the plate 18a and the cover 20a can optionally be plate parts of the same dimensions, both of which have recesses to form the chambers 12, 14 and 16 and the various approvals.

The chamber 12 preferably contains a blood filter element 22 around a first port 24 which in turn communicates between the chamber 12 and a flexible conduit 26 connected to a patient's vein is connectable. The venous line 26 can be a sterile injection site 28 for taking blood samples in a conventional manner or drug delivery, a clamp 30 and a removable sterile closure 32 for sealing the line

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exhibit. The line 26 can be connected to a hollow needle for introduction into the patient, to an artery-vein bridge or to any other means of establishing communication with the patient's venous system be connected.

The chamber 12 also contains a second admission in the form a conduit 34 which forms an elongated passage for connection to a blood outlet conduit 36, which the Blood from the dialyzer 38 is supplied. In the embodiment shown, the dialyzer 38 is a commercially available one Hollow fiber dialyzer, but the invention is applicable to any type of dialyzer.

The blood exiting from the dialyzer 38 thus flows into the chamber 12 at the upper end thereof, in order to pass through the filter to flow into the venous line 26 and to be returned to the patient via this.

The second chamber 14 is connected via an inlet or a line 40 with a blood line 42, which in turn is connected a patient's arterial system can be connected. The line 42 can also be a conventional injection site 28, a clip 30 and a sterile closure 32, and other common equipment. If desired, can lines 26 and 42 through a thin plastic web 44 be integrally connected to one another, which is torn open over a desired length of the length of the two lines 26 and 42 can be, in its intact area, however, the two lines uniformly hold together to avoid confusion as well as to prevent disruptive separate movement and rolling up of the individual lines.

The lines 26 and 42 can expediently together and

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be extruded in one piece, so that between them the tearable Connecting web 44 is formed. For appropriate identification of the lines 26 and 42 can be on them suitable markings, for example colored lines 46 and 48, respectively, are attached.

The blood supplied via line 42 flows over a third inlet 40, preferably at an entry point 50 which is approximately half the length of the chamber 14, so that in this chamber an upper area 52 for receiving and Trapping of gas bubbles is present.

The blood then exits the chamber 14 at the lower end thereof in the downward direction via a fourth admission or a fourth Line 54, which in turn is connected to a blood pump line piece 56. Line 56 can be a roller blood pump be switched on to transfer the blood from the chamber 14 to the chamber 16 and convey it through the entire system.

If desired, a terminal 60 controlled Saline solution infusion line 58 for occasional use - be connected to the inlet 54 in a sterile manner.

From the line 56, the blood enters a fifth inlet 62, which leads to the chamber 16 and about halfway through Height of this chamber lying point, similar to the entry point 50, with this chamber is in connection, so that the Chamber fulfills a similar bubble separation function.

The blood suction from the chamber 16 with the assistance of a The blood pump switched into the line 56 takes place via a sixth admission or a sixth line 64, which in turn lead with a into the blood inlet of the dialyzer 38-

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- 12 communicates with the inlet line 66.

If desired, a heparin administration line can be connected to the inlet 62 70, which has a sterile end cap 72 for connection to a suitable heparin administration Device carries, with the help of which over a certain period of time dosed amounts of heparin into the bloodstream can be introduced.

The blood from the patient's arterial system thus flows via line 42 to the inlet for the separation of bubbles 40 to chamber 14 and from there via the inlet 54 to the Purapen line 56.

Under the pumping by the blood pump, the blood is over the admission 62 for further bubble separation into the Kanmer 16 transferred and passed from this via the inlet 64 to the dialyzer 38. The dialyzed blood flows in via line 34 the chamber 12. This blood then flows through the filter 22, the inlet 24 and into the venous line for return to the patient 26th

The hydraulic circuit unit 10 carries clamping pieces 74 for clamping the dialyzer 38 in the manner shown, see above that a conveniently operable, unitary construction is formed, which both the dialyzer and the largest Includes part of its flow paths. The whole construction can have a hanging or fastening element (not shown) have, with the help of which it can be attached to a corresponding hanging frame. Each chamber 12, 14, 16 has one upper, outwardly protruding nozzle 76. On each nozzle is a closed or sealed injection point element 78 connected, which may contain a latex element pressed into a pipe part, similar to the current, commercial injection site elements is the case,

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as in arterial and vein (conduction) sentences for the Dialysis can be used. The excess air trapped in the chambers can be supplied via the relevant injection or Puncture parts 78 sucked off with the aid of a hollow needle and syringe will.

A hose line 80 is connected to each of the outwardly protruding, upper connecting pieces 76 of each chamber or closed end to a manometer or other pressure measuring device can be connected to a carry out immediate measurement of the pressure prevailing in the chambers 12, 14 or 16. When the hose lines 80 are not used, they are closed with the aid of clamps 82. The directly to the relevant chamber 12, 14 or 16 connected hose line 80 can optionally be replaced by a pressure measuring element 84, which the in the pressure prevailing in the chambers concerned indirectly, i.e. without reaching into these chambers.

According to Fig. 4, the pressure measuring element 84 has a housing 86 which has an opening or bore 88 in a part of the Wall of the unit 10 can be placed, which is connected to the passage 76. A arranged above the bore 88, liquid-impermeable, flexible membrane 90 is located in the effective measuring range of a pressure transducer 92, which the size of the outward or inward bulging of the membrane 90 is able to measure as a function of an overpressure or underpressure in the passage 76.

The pressure prevailing in the individual chambers 12, 14, 16 is thus determined by the size of the outward or inward curvature of the membrane 90 is reflected. This membrane bulge is in turn tapped by the transducer 92 and (in the form of a signal) via an electrical line 94 to a conventional

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Indicator transmitted so that the prevailing pressures in the chambers 12, 14 and 16 are monitored as required while the system itself remains locked and sealed.

If desired, the dialyzer 38 can be part of the hydraulic circuit unit 10 are formed, in which case the hollow fibers and the erdialysers usually used in hollow fibers Potting compound or another membrane material is used with the carriers in a bore provided infer unit 10 so that the unit 10 also takes over the puncture of the dialyzer.

It goes without saying that the above disclosure is intended to explain the invention only by way of example and by no means limit, since various changes and modifications are possible for those skilled in the art without departing from the scope of the invention is deviated.

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Claims (16)

2B2Ü256 Henkel, Kern, Feiler & Hänzef patent attorneys Baxter Travenol Laboratories, Ine. Möhlstrasse 37 D-8000 Munich 80 Deerfield, 111., V.St.A. Tel .: 089 / 982085-87 Telex: 0529802 hnkld Telegrams: ellipsoid k May 9, 1978 Claims 1. One-piece hydraulic circuit unit for use with a blood dialyzer, characterized by a rigid one or rigid, one-piece part (10), the three spaced apart chambers (12, 14, 16), one communicating with the first chamber (12) and being connectable to a venous line (26) leading to a patient first inlet (24) and one with the first chamber (12) in communication, to the outlet of one Blood dialyzer (38) has connectable second inlet (34), wherein the second chamber (14) with a third, is connected to an arterial line (42) of the patient connectable inlet (40) and also with a communicates fourth inlet (54) which can be connected to a blood delivery or pump line (56), and the third Chamber (16) with a fifth, with the blood pump line connectable inlet (62) and with a sixth, with the inlet of the blood dialyzer (38) communicable inlet (64) communicates. 2. Unit according to claim 1, characterized in that the the first chamber includes a blood filter (22) for filtering gases from the blood stream through the first port. 809847/0798
Ke / Bl / ro -z- 3. Unit according to claim 1, characterized in that the rigid, one-piece part (10) is a flat plastic plate is that the chambers and admissions are formed as recesses in this plate and that the plate with a cover element (20) is covered as a closure for the recesses. 4. Unit according to claim 3, characterized in that the first and the second chamber each have an opening, which by means of a liquid-tight, flexible Membrane is sealed, and that on the membrane outside of the chamber in question each a Druckmeßeinricrtung is arranged, which measures the deflection of the membrane as a function of the pressure prevailing in each chamber. 5. Unit according to claim 3, characterized in that a saline solution infusion line is connected to the fourth admission is. 6. Unit according to claim 5, characterized in that a heparin line is connected to the fifth inlet. 7. Unit according to claim 3> characterized in that a sealable or closable injection site is provided, via which a connection is established by means of an injection needle can be produced with the chambers, 8. Unit according to claim 3, characterized in that it has means for bracing and holding a blood dialyzer having. 9. Unit according to claim 3, characterized in that the the first inlet is connected to a venous line and the third inlet is connected to an arterial line, these lines are interconnected along one side for most of their length. 809847/0798 10. Unit according to claim 3, characterized in that the third and the fifth admission with the second or the third chamber communicates at a point approximately in the middle of its length, while the fourth and the sixth admission communicates with a lower end of the second and the third chamber, respectively. 11. Unit according to claim 10, characterized in that the first admission with the lower end of the first chamber communicates and the second inlet near the upper end of the first chamber is connected to this. 12. Unit according to claim 3 »characterized in that it has a blood dialyzer. 13. One-piece hydraulic circuit unit for a blood dialyzer, in particular according to one of the preceding claims, characterized characterized in that it has a rigid, integral part in which chambers and ports are formed are that means for connecting a first inlet to a venous line leading to the patient are provided to the blood from the outlet of a blood dialyzer via the unit to the venous system of the patient direct that another inlet of the unit is connectable to a patient arterial line to transfer the blood directing the unit to the inlet of the dialyzer and that the unit also has bubble trap chamber facilities for the separation of (gas) bubbles from the blood which has entry into the blood dialyzer and prior to entry into the patient's venous system. 14. Unit according to claim 13, characterized in that intermediate ports in the blood flow path through the unit are provided which are connected to a blood pump or delivery line. ! - <0 9 B 4 7/0 7 9 8 15. Unit according to claim 14, characterized in that the blood dialyzer as part of the hydraulic circuit unit is designed. 16. Unit according to claim 15, characterized in that arterial and venous lines are connected to the admission, over the greater part of their length on their
one side are connected to each other. 809847/0798