CA2354913C - Blood treatment and disposable kit for a blood treatment device - Google Patents
Blood treatment and disposable kit for a blood treatment device Download PDFInfo
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- CA2354913C CA2354913C CA002354913A CA2354913A CA2354913C CA 2354913 C CA2354913 C CA 2354913C CA 002354913 A CA002354913 A CA 002354913A CA 2354913 A CA2354913 A CA 2354913A CA 2354913 C CA2354913 C CA 2354913C
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- blood treatment
- closure members
- treatment device
- pump
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/30—Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/30—Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
- A61M1/301—Details
- A61M1/302—Details having a reservoir for withdrawn untreated blood
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/30—Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
- A61M1/301—Details
- A61M1/303—Details having a reservoir for treated blood to be returned
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
- A61M1/36225—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit with blood pumping means or components thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
- A61M1/36226—Constructional details of cassettes, e.g. specific details on material or shape
- A61M1/362265—Details of valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
- A61M2205/128—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with incorporated valves
Abstract
A blood treatment device, in particular a dialysis machine, which permits both single-needle and dual--needle operation, has a blood treatment unit, in particular a dialyzer 1, whose inlet is connected to a feed line 5 and whose outlet is connected to a return line 6. The feed line 5 has two parallel line branches 10, 11, with a first positive displacement pump 12 being connected into the first line branch and a second positive displacement pump 13 being connected into the second line branch 11. To produce a fluid connection between the outlet of the dialyzer 1 and one of the two pumps 13, a connection line 18 is provided. For dual--needle operation, the feed and return lines are connected to an arterial and a venous needle 32, 33, while for single-needle operation, the feed and return lines are brought together and connected to a common needle 9. The connection line 18 permits single-needle operation without great changes to the structure of the blood treatment device.
Description
Blood Treatment Device and Disposable Kit for a Blood Treatment Device The invention relates to a blood treatment device, in particular a dialysis machine, which has a blood treatment unit, in particular a dialyzer. The invention further relates to a disposable kit for such a blood treatment device.
Various dialysis methods are known. In dual-needle dialysis, blood is drawn off from a patient via one needle and returned to the patient via another needle. In this case, the blood is pumped continuously through the dialyzer. Single-needle dialysis requires only a single needle in order to draw off and return blood cyclically, i.e. the arterial and venous blood lines are connected to the same needle.
Single-needle and dual-needle dialysis machines generally make use of occluding tube pumps. Dialysis machines are known, however, in which positive displacement pumps are used to pump the blood.
DE 39 11 587 Al describes a single-needle dialysis machine, in which the blood, in a first phase, is drawn off by a needle via an arterial branch and, in a second phase, is returned via a venous branch by the same needle. In order to make it possible to achieve continuous blood flow via the dialyzer, even in the case of single-needle dialysis, compensation chambers are connected into the arterial and venous branches. Single-needle dialysis is less stressful for the patient, but the control of the blood flow via the common needle is more demanding than in the case of dual-needle dialysis.
W084/02473 and W098/22165 disclose blood treatment devices in which various components that form a functional unit are combined in a cassette. This modular design has the advantage that the parts of the system coming into contact with the blood can be replaced easily. A disadvantage, however, is that the flow plan is dictated by the design of the model. If, for example, the module is to be configured for dual-needle operation, then single-needle operation is not possible, or vice versa.
It is an object of the invention to offer a blood treatment device which allows both single-needle and dual-needle operation, without great changes having to be made to the flow plan of the device. It is another object of the invention to provide a disposable kit for such a blood treatment device.
These objects are achieved according to the invention by the features of patent claims 1 and 13, respectively.
The term blood treatment device is intended to mean all devices which have an extracorporeal circuit with a unit for treating blood. These include, in particular, devices for hemodialysis, hemofiltration and hemodiafiltration but also, for example, cell separators.
For the delivery of blood, the blood treatment device has two positive displacement pumps, preferably diaphragm pumps, with the first pump being connected into the first line branch and the second pump being connected into the second line branch of a branching feed line, via which the blood is drawn off from the patient and supplied to the blood treatment unit, for example the dialyzer. The blood from the blood treatment unit is returned via a discharge line.
For dual-needle operation, a needle is attached both to the feed line and the return line. The two pumps operate in alternation. While one pump is taking blood in, the other pump delivers blood into the blood treatment unit, so that blood flows continuously through the blood treatment unit.
A connection line for producing a fluid connection between the outlet of the blood treatment unit and one of the two pumps permits single-needle operation without great changes to the flow plan. The feed and return lines are connected to a common needle during single-rleedle operation. In a first phase, both pumps take blood in via the open fluid connection, with the blood flowing through the first pump and the blood treatment unit to the second pump. The blood is not returned via the return line in this phase. In a subsequent second phase, the fluid connection remains open, with both pumps delivering blood that is returned via the return line.
In an alternative embodiment, the common needle may be attached only to the feed line, with the blood being drawn off and returned only via the feed line in this embodiment.
The parts of the blood treatment device coming into contact with the blood are preferably designed as a disposable kit, although they may also be part of the blood treatment device.
The disposable kit for the blood treatment device has a feed line with two parallel line branches, and a return line,-and pump chambers connected into the first and second line branches, as well as a connection line. The disposable kit may, however, also comprise yet other components, for example main chambers etc. The blood treatment unit may also be part of the disposable kit.
The disposable kit may be designed as a tube set. It is, however, also possible to fit all parts of the disposable kit in one functional unit, for example in the form of a film part.
The blood treatment unit preferably has a holding unit, known from the prior art, into which the disposable kit is put. The pumps and closure members for controlling the blood flow are then part both of the disposable kit and of the holding unit. Disposable kits and holding units having such pumps and closure members are, for example, described in DE 198 14 695 Al, and WO 99/17019, to which reference is expressly made.
The advantages of the invention are effective, in particular, when the parts coming into contact with the blood are designed as a disposable kit, which is put into the holding unit on the machine side. To perform single-needle operation, only minor changes need to be made to the disposable kit and to the holding unit. To that end, only a short sealable tap line is required, which should be as short as possible so that the dead volume is small.
Several exemplary embodiments of the invention will be explained in more detail below with reference to the drawings, in which:
Fig. 1 shows the essential components of a blood treatment device for single-needle operation in a simplified representation, Fig. 2 shows a simplified representation of the part that holds a pump chamber of the disposable kit, in the holding unit of the blood treatment device of Fig.
1, Fig. 3 shows an alternative embodiment of the blood treatment device for sinale-needle operation, and Fig. 4 shows a blood treatment device for dual-needle operation.
Figure 1 shows the essential components of the blood treatment device, which has a blood treatment unit 1. The blood treatment unit 1 may, for example, be a dialyzer which is divided by a semipermeable membrane 2 into a blood chamber 3 and a dialyzer fluid chamber 4.
During the dialysis treatment, blood flows through the blood chamber 3 and dialyzer fluid flows through the dialyzer fluid chamber 4. The flow directions are marked by arrows in Figure 1.
The patient's blood is supplied to the blood chamber 3 of the dialyzer 1 via a feed line 5, and is returned from the blood chamber via a return line 6. The feed and return lines 5, 6 respectively have connectors 5a, 5b and 6a, 6b at their ends. The feed and return lines are attached to the inlet and outlet 3a, 3b of the blood chamber by means of the connectors 5a, 6a.
For single-needle dialysis, the free ends of the feed and return lines 5, 6 are connected by means of a Y-connection piece 7 that has two individual line branches 7a, 7b and a common line branch 7c. To attach the Y-connection piece 7, the connectors 5b, 6b of the feed and return lines 5, 6 are connected to the corresponding connectors 7d, 7e of the connection piece.
A common blood line 8, to which a common needle 9 is attached, is connected to the common line branch of the connection piece 7.
The feed line 5 has two parallel line branches 10, 11, with one positive displacement pump, preferably a diaphragm pump, 12, being connected into the first line branch 10 and a second positive displacement pump, preferably a diaphragm pump, 13, being connected into the second line branch 11. A first closure member 14 is arranged in the line section l0a of the first line branch 10 leading to the first pump 12, a second closure member 15 is arranged in the line section lOb of the first line branch 10 leading off from the first pump, a third closure member 16 is arranged in the section lla of the second line branch 11 leading to the second pump 13 and a fourth closure member 17 is arranged in the line section llb of the second line branch 11 leading off from the second pump.
To produce a fluid connection between the outlet of the blood chamber 3 and the second pump 13, a connection line 18 is provided that branches off from the return line 6 and is attached to the second line section llb of the second line branch 11 between the second pump 13 and the fourth closure member 17. A fifth closure member 19 is provided in the connection line 18.
A sixth closure member 20 is provided at the feed line 5, and a seventh closure member 21 is provided at the return line 6. The sixth closure member in the feed line is not, however, compulsory in this embodiment.
The feed and return lines 5, 6 and the connection line 18 are designed, together with the pump chambers 12a, 13a of the pumps 12, 13, as a disposable kit that is put into a holding unit 22 (represented only by way of indication by broken lines) of the blood treatment device.
Figure 2 shows the part in the holding unit 22 that holds the pump chamber 12a or 13a of the pump 12 or 13, respectively. The holding unit 22 consists of a lower and an upper housing body 23, 24, each of which has a trough-like recess 25, 26. The lower trough-like recess 25 holds a pressure chamber 27 which is alternately filled with and emptied of a gas or a liquid via inlet and outlet channels 28, 29, respectively. The pump chamber 12a or 13a of the first or second pump 12, 13, respectively, is put into the upper trough-like recess 26. During filling, the pressure chamber 27 inflates so that the pump chamber 12a or 13a is compressed (delivery phase) . When the pressure chamber is being emptied, the pump chamber expands (intake operation) . Such holding units are known, for example, from WO 99/17019, to which reference is expressly made.
The closure members are clamp devices that engage on the lines. and are electromagnetically or pneumatically actuated by a control unit 30 that is connected via control lines 31a to 31g to the individual closure members. The control unit 30 is further connected via control lines 31h, 31i to the two pumps 12, 13.
For single-needle dialysis, the disposable kit is put into the holding unit, and the dialyzer 1 and the Y-connection piece 7 are attached. The control unit 30 drives the pumps 12, 13 and the closure members as follows:
Initially, all the closure members are closed.
At the start of a first phase, the control unit 30 opens the first, second, fifth and sixth closure members 14, 15, 19, 20, and switches the first and second pumps 12, 13 to intake operation. The first and second pumps 12, 13 now take in blood from the patient through the needle 9 until both pump chambers 12a, 13a are filled with a particular fluid volume. In this case, blood flows through the first pump chamber 12a, the blood chamber 3 and the connection line 18 into the second pump chamber 13a. When both pump chambers 12a, 13a are filled with the desired vo1 ume, all the closure members are re-closed. This is followed by a second phase. At the start of the second phase, the control unit 30 switches the first and second pumps 12, 13 to delivery operation and opens the second, fifth and seventh closure members 15, 19, 21. The blood from the pump chambers 12a, 13a is now returned via the return line 6 through the needle 9. The second phase is then followed again by the first phase.
During the first and second phases, blood flows continuously through the dialyzer fluid chamber 3 of the dialyzer 1. It is not compulsory for all the closure members to be closed between the two phases. For example, the second and fifth closure members 15 and 19 may remain open.
Figure 3 shows an alternative exemplary embodiment of the blood treatment device for single-needle dialysis. In this exemplary embodiment, the needle 9 is attached directly to the connector 5b of the feed line 5. Therefore, the section of the return line 6 attached to the Y-connection piece 7 is not per se necessary. The Y-connection piece may be omitted, which makes the structure even simpler. In other regards, the structure of the exemplary embodiment according to Figure 2 is identical to the structure of the embodiment according to Figure 1. The pumps and closure members are driven as follows in the exemplary embodiment according to Figure 2:
In the first phase, the control unit 30 switches the first and second pumps 12, 13 to intake operation and opens the first, second, fifth and sixth closure members 14, 15, 19, 20 and closes the third, fourth and seventh closure members 16, 17, 21, so that the two pump chambers 12a, 13a can fill with blood. In this case, blood flows through the first chamber 12a, the dialyzer fluid chamber 3, the connection line 18 into the second chamber 13a. In the subsequent second phase, the control unit 30 switches the chambers 12a, 13a to delivery operation and opens the second, third, fifth and sixth closure members 15, 16, 19, 20 and closes the first, fourth and seventh closure members 14, 17, 21, so that the blood is returned from both chambers 12a, 13a via the feed line 5. In this case, blood flows through the dialyzer fluid chamber 3. All the closure members are re-closed between the two phases. This is not, however compulsory. For instance, the sixth closure member 20 may also remain open.
Figure 4 shows the blood treatment device for dual-needle dialysis. The structure corresponds to the embodiments according to Figures 1 and 3. For dual-needle operation, an arterial needle is attached to the connector 5b of the feed line 5 and a venous needle 33 is attached to the connector 6b of the return line 6.
The sixth and seventh closure members 20, 21 are always open, and the fifth closure member 19 is always closed. During the first phase, the control unit 30 switches the first pump 12 to intake operation and the second pump 13 to delivery operation. The first and fourth closure members 14, 17 are opened and the second and third closure members 15, 16 are closed. While the first pump 12 is taking blood in through the arterial needle 9 via the feed line 5, the second pump 13 supplies the blood chamber 3 with blood that is returned via the return line 6 through the venous needle 33.
After the first pump chamber 12a has been filled and the second pump chamber 13a has been emptied, the control unit 30 switches, in the second phase, the first pump 12 to delivery operation and the second pump 13 to intake operation and opens the.second and third closure members 15, 16 and closes the first and fourth closure members 14, 17. The first pump 12 now supplies the blood chamber 3 with blood that is returned through the venous needle 33, while the second pump 13 takes blood in through the arterial needle 9.
Should complications arise with a patient's vascular accesses during dual-needle dialysis, the blood treatment device according to the invention may be refitted for single-needle dialysis with a few actions.
To that end, changes to the needles 9, 33 and their contacts may p-ossibly be necessary. Further, only the valve and pump control needs to be changed as described above, without there being a need to replace the disposable kit placed in the holding unit 22. In this way, very rapid refitting is possible.
Various dialysis methods are known. In dual-needle dialysis, blood is drawn off from a patient via one needle and returned to the patient via another needle. In this case, the blood is pumped continuously through the dialyzer. Single-needle dialysis requires only a single needle in order to draw off and return blood cyclically, i.e. the arterial and venous blood lines are connected to the same needle.
Single-needle and dual-needle dialysis machines generally make use of occluding tube pumps. Dialysis machines are known, however, in which positive displacement pumps are used to pump the blood.
DE 39 11 587 Al describes a single-needle dialysis machine, in which the blood, in a first phase, is drawn off by a needle via an arterial branch and, in a second phase, is returned via a venous branch by the same needle. In order to make it possible to achieve continuous blood flow via the dialyzer, even in the case of single-needle dialysis, compensation chambers are connected into the arterial and venous branches. Single-needle dialysis is less stressful for the patient, but the control of the blood flow via the common needle is more demanding than in the case of dual-needle dialysis.
W084/02473 and W098/22165 disclose blood treatment devices in which various components that form a functional unit are combined in a cassette. This modular design has the advantage that the parts of the system coming into contact with the blood can be replaced easily. A disadvantage, however, is that the flow plan is dictated by the design of the model. If, for example, the module is to be configured for dual-needle operation, then single-needle operation is not possible, or vice versa.
It is an object of the invention to offer a blood treatment device which allows both single-needle and dual-needle operation, without great changes having to be made to the flow plan of the device. It is another object of the invention to provide a disposable kit for such a blood treatment device.
These objects are achieved according to the invention by the features of patent claims 1 and 13, respectively.
The term blood treatment device is intended to mean all devices which have an extracorporeal circuit with a unit for treating blood. These include, in particular, devices for hemodialysis, hemofiltration and hemodiafiltration but also, for example, cell separators.
For the delivery of blood, the blood treatment device has two positive displacement pumps, preferably diaphragm pumps, with the first pump being connected into the first line branch and the second pump being connected into the second line branch of a branching feed line, via which the blood is drawn off from the patient and supplied to the blood treatment unit, for example the dialyzer. The blood from the blood treatment unit is returned via a discharge line.
For dual-needle operation, a needle is attached both to the feed line and the return line. The two pumps operate in alternation. While one pump is taking blood in, the other pump delivers blood into the blood treatment unit, so that blood flows continuously through the blood treatment unit.
A connection line for producing a fluid connection between the outlet of the blood treatment unit and one of the two pumps permits single-needle operation without great changes to the flow plan. The feed and return lines are connected to a common needle during single-rleedle operation. In a first phase, both pumps take blood in via the open fluid connection, with the blood flowing through the first pump and the blood treatment unit to the second pump. The blood is not returned via the return line in this phase. In a subsequent second phase, the fluid connection remains open, with both pumps delivering blood that is returned via the return line.
In an alternative embodiment, the common needle may be attached only to the feed line, with the blood being drawn off and returned only via the feed line in this embodiment.
The parts of the blood treatment device coming into contact with the blood are preferably designed as a disposable kit, although they may also be part of the blood treatment device.
The disposable kit for the blood treatment device has a feed line with two parallel line branches, and a return line,-and pump chambers connected into the first and second line branches, as well as a connection line. The disposable kit may, however, also comprise yet other components, for example main chambers etc. The blood treatment unit may also be part of the disposable kit.
The disposable kit may be designed as a tube set. It is, however, also possible to fit all parts of the disposable kit in one functional unit, for example in the form of a film part.
The blood treatment unit preferably has a holding unit, known from the prior art, into which the disposable kit is put. The pumps and closure members for controlling the blood flow are then part both of the disposable kit and of the holding unit. Disposable kits and holding units having such pumps and closure members are, for example, described in DE 198 14 695 Al, and WO 99/17019, to which reference is expressly made.
The advantages of the invention are effective, in particular, when the parts coming into contact with the blood are designed as a disposable kit, which is put into the holding unit on the machine side. To perform single-needle operation, only minor changes need to be made to the disposable kit and to the holding unit. To that end, only a short sealable tap line is required, which should be as short as possible so that the dead volume is small.
Several exemplary embodiments of the invention will be explained in more detail below with reference to the drawings, in which:
Fig. 1 shows the essential components of a blood treatment device for single-needle operation in a simplified representation, Fig. 2 shows a simplified representation of the part that holds a pump chamber of the disposable kit, in the holding unit of the blood treatment device of Fig.
1, Fig. 3 shows an alternative embodiment of the blood treatment device for sinale-needle operation, and Fig. 4 shows a blood treatment device for dual-needle operation.
Figure 1 shows the essential components of the blood treatment device, which has a blood treatment unit 1. The blood treatment unit 1 may, for example, be a dialyzer which is divided by a semipermeable membrane 2 into a blood chamber 3 and a dialyzer fluid chamber 4.
During the dialysis treatment, blood flows through the blood chamber 3 and dialyzer fluid flows through the dialyzer fluid chamber 4. The flow directions are marked by arrows in Figure 1.
The patient's blood is supplied to the blood chamber 3 of the dialyzer 1 via a feed line 5, and is returned from the blood chamber via a return line 6. The feed and return lines 5, 6 respectively have connectors 5a, 5b and 6a, 6b at their ends. The feed and return lines are attached to the inlet and outlet 3a, 3b of the blood chamber by means of the connectors 5a, 6a.
For single-needle dialysis, the free ends of the feed and return lines 5, 6 are connected by means of a Y-connection piece 7 that has two individual line branches 7a, 7b and a common line branch 7c. To attach the Y-connection piece 7, the connectors 5b, 6b of the feed and return lines 5, 6 are connected to the corresponding connectors 7d, 7e of the connection piece.
A common blood line 8, to which a common needle 9 is attached, is connected to the common line branch of the connection piece 7.
The feed line 5 has two parallel line branches 10, 11, with one positive displacement pump, preferably a diaphragm pump, 12, being connected into the first line branch 10 and a second positive displacement pump, preferably a diaphragm pump, 13, being connected into the second line branch 11. A first closure member 14 is arranged in the line section l0a of the first line branch 10 leading to the first pump 12, a second closure member 15 is arranged in the line section lOb of the first line branch 10 leading off from the first pump, a third closure member 16 is arranged in the section lla of the second line branch 11 leading to the second pump 13 and a fourth closure member 17 is arranged in the line section llb of the second line branch 11 leading off from the second pump.
To produce a fluid connection between the outlet of the blood chamber 3 and the second pump 13, a connection line 18 is provided that branches off from the return line 6 and is attached to the second line section llb of the second line branch 11 between the second pump 13 and the fourth closure member 17. A fifth closure member 19 is provided in the connection line 18.
A sixth closure member 20 is provided at the feed line 5, and a seventh closure member 21 is provided at the return line 6. The sixth closure member in the feed line is not, however, compulsory in this embodiment.
The feed and return lines 5, 6 and the connection line 18 are designed, together with the pump chambers 12a, 13a of the pumps 12, 13, as a disposable kit that is put into a holding unit 22 (represented only by way of indication by broken lines) of the blood treatment device.
Figure 2 shows the part in the holding unit 22 that holds the pump chamber 12a or 13a of the pump 12 or 13, respectively. The holding unit 22 consists of a lower and an upper housing body 23, 24, each of which has a trough-like recess 25, 26. The lower trough-like recess 25 holds a pressure chamber 27 which is alternately filled with and emptied of a gas or a liquid via inlet and outlet channels 28, 29, respectively. The pump chamber 12a or 13a of the first or second pump 12, 13, respectively, is put into the upper trough-like recess 26. During filling, the pressure chamber 27 inflates so that the pump chamber 12a or 13a is compressed (delivery phase) . When the pressure chamber is being emptied, the pump chamber expands (intake operation) . Such holding units are known, for example, from WO 99/17019, to which reference is expressly made.
The closure members are clamp devices that engage on the lines. and are electromagnetically or pneumatically actuated by a control unit 30 that is connected via control lines 31a to 31g to the individual closure members. The control unit 30 is further connected via control lines 31h, 31i to the two pumps 12, 13.
For single-needle dialysis, the disposable kit is put into the holding unit, and the dialyzer 1 and the Y-connection piece 7 are attached. The control unit 30 drives the pumps 12, 13 and the closure members as follows:
Initially, all the closure members are closed.
At the start of a first phase, the control unit 30 opens the first, second, fifth and sixth closure members 14, 15, 19, 20, and switches the first and second pumps 12, 13 to intake operation. The first and second pumps 12, 13 now take in blood from the patient through the needle 9 until both pump chambers 12a, 13a are filled with a particular fluid volume. In this case, blood flows through the first pump chamber 12a, the blood chamber 3 and the connection line 18 into the second pump chamber 13a. When both pump chambers 12a, 13a are filled with the desired vo1 ume, all the closure members are re-closed. This is followed by a second phase. At the start of the second phase, the control unit 30 switches the first and second pumps 12, 13 to delivery operation and opens the second, fifth and seventh closure members 15, 19, 21. The blood from the pump chambers 12a, 13a is now returned via the return line 6 through the needle 9. The second phase is then followed again by the first phase.
During the first and second phases, blood flows continuously through the dialyzer fluid chamber 3 of the dialyzer 1. It is not compulsory for all the closure members to be closed between the two phases. For example, the second and fifth closure members 15 and 19 may remain open.
Figure 3 shows an alternative exemplary embodiment of the blood treatment device for single-needle dialysis. In this exemplary embodiment, the needle 9 is attached directly to the connector 5b of the feed line 5. Therefore, the section of the return line 6 attached to the Y-connection piece 7 is not per se necessary. The Y-connection piece may be omitted, which makes the structure even simpler. In other regards, the structure of the exemplary embodiment according to Figure 2 is identical to the structure of the embodiment according to Figure 1. The pumps and closure members are driven as follows in the exemplary embodiment according to Figure 2:
In the first phase, the control unit 30 switches the first and second pumps 12, 13 to intake operation and opens the first, second, fifth and sixth closure members 14, 15, 19, 20 and closes the third, fourth and seventh closure members 16, 17, 21, so that the two pump chambers 12a, 13a can fill with blood. In this case, blood flows through the first chamber 12a, the dialyzer fluid chamber 3, the connection line 18 into the second chamber 13a. In the subsequent second phase, the control unit 30 switches the chambers 12a, 13a to delivery operation and opens the second, third, fifth and sixth closure members 15, 16, 19, 20 and closes the first, fourth and seventh closure members 14, 17, 21, so that the blood is returned from both chambers 12a, 13a via the feed line 5. In this case, blood flows through the dialyzer fluid chamber 3. All the closure members are re-closed between the two phases. This is not, however compulsory. For instance, the sixth closure member 20 may also remain open.
Figure 4 shows the blood treatment device for dual-needle dialysis. The structure corresponds to the embodiments according to Figures 1 and 3. For dual-needle operation, an arterial needle is attached to the connector 5b of the feed line 5 and a venous needle 33 is attached to the connector 6b of the return line 6.
The sixth and seventh closure members 20, 21 are always open, and the fifth closure member 19 is always closed. During the first phase, the control unit 30 switches the first pump 12 to intake operation and the second pump 13 to delivery operation. The first and fourth closure members 14, 17 are opened and the second and third closure members 15, 16 are closed. While the first pump 12 is taking blood in through the arterial needle 9 via the feed line 5, the second pump 13 supplies the blood chamber 3 with blood that is returned via the return line 6 through the venous needle 33.
After the first pump chamber 12a has been filled and the second pump chamber 13a has been emptied, the control unit 30 switches, in the second phase, the first pump 12 to delivery operation and the second pump 13 to intake operation and opens the.second and third closure members 15, 16 and closes the first and fourth closure members 14, 17. The first pump 12 now supplies the blood chamber 3 with blood that is returned through the venous needle 33, while the second pump 13 takes blood in through the arterial needle 9.
Should complications arise with a patient's vascular accesses during dual-needle dialysis, the blood treatment device according to the invention may be refitted for single-needle dialysis with a few actions.
To that end, changes to the needles 9, 33 and their contacts may p-ossibly be necessary. Further, only the valve and pump control needs to be changed as described above, without there being a need to replace the disposable kit placed in the holding unit 22. In this way, very rapid refitting is possible.
Claims (14)
1. A blood treatment device having a blood treatment unit (1) that has an inlet (3a) and an outlet (3b), a feed line (5) that leads to the inlet of the blood treatment unit and has two parallel line branches (10, 11), and a return line (6) that leads off from the outlet of the blood treatment unit, a first positive displacement pump (12) connected into the first line branch and a second positive displacement pump (13) connected into the second line branch, with a first closure member (14) being provided at the line section (10a) of the first line branch leading to the first pump, a second closure member (15) being provided at the line section (10b) of the first line branch leading off from the first pump, a third closure member (16) being provided at the line section (11a) of the second line branch leading to the second pump, and a fourth closure member (17) being provided at the line section (11b) of the second line branch leading off from the second pump, and a connection (18) that connects the outlet (3b) of the blood treatment unit to one of the two line branches, with a fifth closure member (19) being provided at the connection line.
2. The blood treatment device as claimed in claim 1, wherein the connection line (18) connects the return line (6) to the line section (11b) of the second line branch (11) leading off from the second pump (13).
3. The blood treatment device as claimed in claim 1 or 2, wherein the feed line (5) and the return line (6) are connected to a common blood line (8), to which a needle (9) is attached, and a seventh closure member (21) is provided at the return line, with a control unit (30) being provided for opening and closing the closure members and for switching over the pumps (12, 13), and being designed in such a way that in a first phase, the first, second and fifth closure members (14, 15, 19) are open and the third, fourth and seventh closure members (16, 17, 21) are closed and, in a subsequent second phase, the second, fifth and seventh closure members (15, 19, 21) are open and the first, third and fourth closure members (14, 16, 17) are closed, with the pumps being switched over from intake operation to delivery operation between the first and second phases.
4. The blood treatment device as claimed in claim 3, wherein between the first and second phases, when the pumps (12, 13) are being switched over, the first to fifth and seventh closure members are closed.
5. The blood treatment device as claimed in claim 1 or 2, wherein a needle (9) is attached to the feed line (5), with a control unit (30) being provided for opening and closing the closure members and for switching over the pumps (12, 13), and being designed in such a way that in a first phase, the first, second and fifth closure members (14, 15, 19) are open and the third and fourth closure members (16, 17) are closed and, in a subsequent second phase, the second, third and fifth closure members (15, 16, 19) are open and the first and fourth closure members (14, 17) are closed, with the pumps being switched over from intake operation to delivery operation between the first and second phases.
6. The blood treatment device as claimed in claim 5, wherein between the first and second phases, when the pumps (12, 13) are being switched over, the first to fifth closure members are closed.
7. The blood treatment device as claimed in claim 1 or 2, wherein an arterial needle (9) is attached to the feed line (5) and a venous needle (33) is attached to the return line, with a control unit (30) being provided for opening and closing the closure members and for switching over the pumps (12, 13), and being designed in such a way that in a first phase, the first and fourth closure members (14, 17) are open and the second, third and fifth closure members (15, 16, 19) are closed and, in a subsequent second phase, the second and third closure members (15, 16) are open and the first, fourth and fifth closure members (14, 17, 19) are closed, with the first pump (12) being switched over from intake operation to delivery operation between the first and second phases and the second pump (13) being switched over from delivery operation to intake operation.
8. The blood treatment device as claimed in claim 7, wherein between the first and second phases, when the pumps are being switched over, the first to fifth closure members are closed.
9. The blood treatment device as claimed in one of claims 1 to 8, wherein the closure members are electromagnetic, or pneumatically actuatable, clamp devices.
10. The blood treatment device as claimed in one of claims 1 to 9, wherein the first and second pumps (12, 13) are diaphragm pumps.
11. The blood treatment device as claimed in one of claims 1 to 10, wherein the first and second pumps (12, 13) respectively have a pump chamber (12a, 13a) that is designed as a replaceable unit, these being connected into the first and second line branches (10, 11) of the feed line (5).
12. The blood treatment device as claimed in claim 11, wherein the feed line (5), the return line (6), the connection line (18) and the pump chambers (12a, 13a) of the first and second pumps (12, 13) are designed as a disposable kit.
13. A disposable kit for a blood treatment device as claimed in one of claims 1 to 12, having a feed line (5) that has two parallel line branches (10, 11), and a return line (6), a first pump chamber (12a) connected into the first line branch (10) and a second pump chamber (13a) connected into the second line branch (11), and a connection line (18) that connects the return line (6) to one of the two line branches (10, 11).
14. The disposable kit as claimed in claim 13, wherein connectors (5b, 6b) for the attachment of needles (9, 3a) or of a Y-connection piece (7) are provided at the free ends of the feed line (5) and the return line (6).
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE10042324.8-41 | 2000-08-29 | ||
| DE10042324A DE10042324C1 (en) | 2000-08-29 | 2000-08-29 | Blood dialysis device has feed line provided with 2 parallel branches for single needle and dual needle operating modes |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2354913A1 CA2354913A1 (en) | 2002-02-28 |
| CA2354913C true CA2354913C (en) | 2008-09-30 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002354913A Expired - Fee Related CA2354913C (en) | 2000-08-29 | 2001-08-09 | Blood treatment and disposable kit for a blood treatment device |
Country Status (11)
| Country | Link |
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| US (1) | US6645166B2 (en) |
| EP (1) | EP1184046B1 (en) |
| JP (1) | JP4520078B2 (en) |
| KR (1) | KR100728522B1 (en) |
| AT (1) | ATE253949T1 (en) |
| AU (1) | AU773648B2 (en) |
| BR (1) | BR0103713B1 (en) |
| CA (1) | CA2354913C (en) |
| DE (2) | DE10042324C1 (en) |
| ES (1) | ES2204793T3 (en) |
| TR (1) | TR200302000T4 (en) |
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2000
- 2000-08-29 DE DE10042324A patent/DE10042324C1/en not_active Expired - Fee Related
-
2001
- 2001-08-09 CA CA002354913A patent/CA2354913C/en not_active Expired - Fee Related
- 2001-08-24 AU AU65460/01A patent/AU773648B2/en not_active Ceased
- 2001-08-25 ES ES01120380T patent/ES2204793T3/en not_active Expired - Lifetime
- 2001-08-25 TR TR2003/02000T patent/TR200302000T4/en unknown
- 2001-08-25 EP EP01120380A patent/EP1184046B1/en not_active Expired - Lifetime
- 2001-08-25 DE DE50100945T patent/DE50100945D1/en not_active Expired - Lifetime
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- 2001-08-27 US US09/940,389 patent/US6645166B2/en not_active Expired - Lifetime
- 2001-08-28 BR BRPI0103713-7A patent/BR0103713B1/en not_active IP Right Cessation
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- 2001-08-28 KR KR1020010051933A patent/KR100728522B1/en not_active IP Right Cessation
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| US6645166B2 (en) | 2003-11-11 |
| EP1184046A1 (en) | 2002-03-06 |
| AU773648B2 (en) | 2004-05-27 |
| EP1184046B1 (en) | 2003-11-12 |
| BR0103713B1 (en) | 2011-08-09 |
| CA2354913A1 (en) | 2002-02-28 |
| KR100728522B1 (en) | 2007-06-15 |
| TR200302000T4 (en) | 2004-01-21 |
| KR20020018040A (en) | 2002-03-07 |
| DE10042324C1 (en) | 2002-02-07 |
| AU6546001A (en) | 2002-03-07 |
| BR0103713A (en) | 2002-06-18 |
| ES2204793T3 (en) | 2004-05-01 |
| US20020041825A1 (en) | 2002-04-11 |
| JP2002119585A (en) | 2002-04-23 |
| JP4520078B2 (en) | 2010-08-04 |
| DE50100945D1 (en) | 2003-12-18 |
| ATE253949T1 (en) | 2003-11-15 |
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