JP2005224597A - Automatic reinfusion apparatus - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an automatic reinfusion apparatus, when reinfused to a patient after finishing a hemodialysis, eliminating contamination and a medical error and preventing it from getting a burden of a medical worker by facilitating an operation. <P>SOLUTION: This automatic reinfusion apparatus, in a hemodialysis circuit, is provided with a fluid replacement supply source and a means of opening/closing a fluid replacement supply source in the fluid replacement line; dialysis fluid supply/discharge lines for perfusing the fluid to a dialyzer; fluid feeding means in the dialysis supply/discharge lines respectively; and at least a single filtration/inverse filtration third fluid feeding means capable of performing normal/inverse rotation for performing the filtration and the inverse filtration and controlling a flow rate, and a removed water discharging means. The blood feeding means and the filtration/inverse filtration third fluid feeding means are connected by an co-operating control means co-operatingly controlling the blood feeding means, the fluid feeding means, the opening/closing means for opening/closing the fluid replacement line, and opening/closing means between an artery connecting end and a fluid replacement line branch part. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention is a hemodialysis apparatus, particularly an automatic blood return apparatus, which can automate as much as possible a series of operations such as hemodialysis and blood collection (returning blood) which have been performed manually until now, and can save labor and prevent erroneous operations. About.

  A hemodialysis apparatus is a medical device for purifying the blood of patients with renal failure and drug addicts. The mechanism of hemodialysis therapy is usually composed of three elements: a hemodialyzer (dialyzer), a blood circuit through which blood circulates, and a dialysate supply system. A hollow hemodialyzer with blood connected to the middle of the blood circuit while maintaining extracorporeal circulation by a blood circuit directly connected to the blood vessel and two puncture needles (in the case of a single needle, there is only one puncture needle) It flows into the compartment on the thread lumen side.

  On the other hand, an electrolyte solution called dialysate flows into the compartment outside the hollow fiber of the hemodialyzer in the direction opposite to the blood flow. Both compartments of the hemodialyzer are separated by a separation membrane called a dialysis membrane, and while the blood and dialysate flow in opposite directions, diffusion movement of substances according to the concentration gradient on both sides of the separation membrane occurs, and uremic toxins and Addictive substances are removed and deficient substances are replenished. In general, the hemodialysis apparatus described above is constituted by a device that controls the maintenance of extracorporeal circulation, the stable supply of dialysate, and the removal of excess water from blood.

In conventional hemodialysis monitoring devices, fluid replacement operations during dialysis treatment, hemodialysis (blood circulation), and blood return operations after dialysis are completed as separate steps. In particular, blood return operations are performed using a inserted puncture needle. The blood vessel was removed from the blood vessel, and care must be taken so that air is not injected into the patient's body. In other words, the so-called “air return” is performed, in which physiological saline is injected into the circuit to start blood return, and after being replaced with the saline solution halfway, the blood is returned while the air is in the circuit. It had been. There is also a risk of air contamination due to the release of air staying in the stepped part or the chamber part in the circuit. Furthermore, in the procedure of extracting the puncture needle on the arterial side and injecting physiological saline from the end of the artery side circuit, there was a mistake such as erroneously extracting the venous side first.
Therefore, it was a mental burden for the medical staff, and a considerable amount of time was taken for blood return operation.

On the other hand, in order to reliably perform dialysis and blood return operation, Patent Document 1 provides a replacement fluid supply means connected via a branch pipe to the main pipe connecting the blood outlet and the return port, and branches the branch pipe. A first clamp that opens and closes the main pipe between the point and the blood outlet; a second clamp that opens and closes the main pipe provided between the second chamber and the blood return port; and the branch pipe. A method for performing hemodialysis and blood return by providing a third clamp for opening and closing the branch pipe and providing a bubble detector in the vicinity of the blood outlet and the return port is disclosed, with the intention of improving the efficiency of the blood return operation. Yes.
Japanese Patent Laid-Open No. 6-261938

As described above, there is a risk of bacterial contamination, operation mistakes in connection / operation sequence, and the like when moving to a blood return operation after completion of hemodialysis, and improvement has been desired. On the other hand, in the method as in the previous example, since the liquid to be injected into the blood circuit only considers physiological saline (medical solution in the replacement fluid bottle), the pressure in the blood circuit during the return stroke to the artery side is It would vary greatly and it was impossible to detect even when a blockage occurred in the circuit.
Therefore, the present invention can be operated easily and simply so that there is no contamination, medical error or operational problem when returning blood to the patient after hemodialysis is completed, and it does not become a burden on the medical staff. It is to provide an automatic blood return device.

In the following description, the reference numerals (numbers) attached to the respective parts are the same as the reference numerals (numbers) in the attached drawings, but are not limited thereto.
In the present invention, the artery side (blood) circuit 1 on the upstream side of the hemodialyzer 2, the vein side (blood) circuit 10 on the downstream side, and the artery side circuit 1 are branched to supply fluid to the circuit. The fluid replacement line 5 and means 18 for opening and closing the fluid replacement line,
The arterial circuit 1 has an arterial connection end A that communicates with a patient's artery via a puncturing means (not shown), and an opening / closing means 19 between the arterial connection end A and the replacement fluid branch 5a. A dialyzer connection end A ′ for connection to the hemodialyzer 2, an arterial chamber 4, a blood pump 3, and the replacement fluid line branching portion 5 a provided in the middle of the both end portions A and A ′, Having bubble detection means 6 and opening / closing means 19;
The venous side circuit 10 includes a dialysis machine connection end B ′ and a venous side connection end B for connection to the hemodialyzer 2, a venous chamber 11 provided in an intermediate part between the both end parts B′B, and bubble detection means. 12, and opening / closing means 13;
The replacement fluid line 5 has a replacement fluid supply source 7 and means 18 for opening and closing the replacement fluid line.
A dialysate supply line 20 for perfusing the dialyzer 2 and a dialysate drainage line 21 are provided, and the dialysate supply line 20 and the dialysate drainage line 21 are provided with liquid feeding means P2 and P3, respectively. Alternatively, at least one third filtration / reverse filtration third feed means capable of forward / reverse rotation and flow rate control for performing filtration and reverse filtration in parallel with the liquid feed means in any of the dialysate drainage lines 21 P1 and slow water draining means P4. The blood pump 3 and the filtration / back-filtration third liquid feeding means P1 are the blood pump 3, the filtration / back-filtration third liquid feeding means P1, the venous side By means of an automatic blood return device, the circuit opening and closing means 13, the fluid replacement opening and closing means 18 and the interlocking control means 16 for controlling the opening and closing means 19 on the arterial circuit 1 in conjunction with each other are connected. Solved the problem.

Further, according to the present invention, the flow rate (flow velocity) of both the blood pump 3 and the filtration / back-filtration third liquid feeding means P1 is substantially equalized or increased by the interlock control means according to each stroke and situation. Alternatively, the interlocking control can be performed so as to reduce the number.
The venous chamber 11 is provided with an overflow line 14 for overflowing the liquid in the chamber, and an opening / closing means 15 is attached to the overflow line.

In the replacement fluid line 5, pressure measuring means P is provided on a communication circuit between the replacement fluid line branch 5 a and the blood pump 3 site or the open / close means 18 between the arterial connection end A and the replacement fluid branch 5 a. .
Further, according to the present invention, the blood circuit 3, the liquid feeding means P2 and P3, the filtration / back-filtration third liquid feeding means P1, the opening / closing means 18 for opening and closing the replacement fluid line, and the arterial line are controlled by the blood circuit internal pressure by the pressure measuring means P. The opening / closing means between the connecting end and the replacement fluid line branching portion can be controlled in conjunction with each other.

  In the present invention, the upstream side (downstream side) means the direction of the flow path (arterial side → venous side) when the blood circuit is connected to the patient's artery / vein and normal hemodialysis is performed. ).

In the above configuration, the automatic blood return device of the present invention drives the opening / closing means 18 of the replacement fluid line 5 and the opening / closing means 19 on the arterial circuit 1 and the blood pump 3 during hemodialysis. It is possible to perform rapid fluid replacement during hemodialysis, and by controlling and adjusting the opening / closing means 18 on the blood pump 3 and the fluid replacement line and the opening / closing means 19 on the arterial circuit, the hemodialysis process can be performed. It is possible to automatically shift to the blood return process. When the dialysis is completed and the blood returning operation is started, the opening / closing means (19) on the arterial circuit is closed in conjunction with opening of the opening / closing means 18 on the replacement fluid line, and the blood returning operation is started.
According to the configuration of the present invention, when moving from the dialysis process to the blood return process, it is not necessary to perform the operation of removing the puncture needle from the patient's body or the operation of detaching the circuit during the blood dialysis → blood return operation. , It is possible to prevent mistakes in the needle removal order and the desorption site. That is, in the conventional blood return operation, blood was returned only in the venous direction, whereas in the present invention, the blood is returned in both the arterial and venous directions. Because there is no.
Further, since the bubble detection means 6 and 12 are attached to both the artery side circuit 1 and the vein side circuit 10, it is possible to prevent bubbles from flowing into the blood vessels of the patient.

  In addition, blood in the circuit and fluid replacement are controlled by interlockingly controlling the flow rates of the opening / closing means 18 of the blood pump 3 and the replacement fluid line 5 and the flow rate of the filtration / reverse filtration third fluid supply means P1 and the opening / closing means 12 of the venous circuit 10. It is possible to control the flow direction and flow rate. As a result, the transition from hemodialysis treatment to blood return operation is easy, and can be performed quickly and reliably.

  According to the automatic blood return apparatus of the present invention, in the replacement operation during hemodialysis and the blood return operation after the completion of dialysis, there is no contamination or erroneous operation, and the manual operation can be automated, thereby improving the efficiency of work. Labor saving is possible. Further, since the operation is automated and simplified, the experience and skill of the worker are not particularly required as in the past.

Furthermore, in the present invention, unique effects can be obtained by various embodiments as described below. That is, the venous circuit 10 has an opening / closing means 13 for opening and closing the venous circuit, and the interlocking control means 16 is connected to the opening / closing means 13 so that the opening / closing means 13 can also be interlocked. Is an automatic blood return device.
In the automatic blood return device of the present invention, the flow rate is adjusted by adjusting the ratio or flow direction of the flow rate of the open / close means 18 of the replacement fluid line 5 and the third liquid supply means P1 of the filtration / reverse filtration and the blood pump 3 and the blood flow rate. Road regulation and selection will be more reliable and safe.

  In the present invention, the interlock control means 16 makes the flow rates (flow velocity) of both the blood pump 3 and the filtration / back-filtration third liquid feeding means P1 substantially equal to or larger according to each stroke and situation, Or it is the said automatic blood return apparatus which can carry out interlocking control so that it may decrease. With the above configuration, the direction and sequence of blood return, and the blood return form (returning blood and veins simultaneously or one after the other in order) can be freely changed, and valuable blood can be collected without wasting it.

Alternatively, the automatic blood return apparatus according to any one of the above, wherein the venous chamber 11 is provided with an overflow line 14 for overflowing the liquid in the chamber, and the opening / closing means 15 is attached to the overflow line. is there.
With the above-described configuration, a part of the liquid can be allowed to flow out from the overflow line 14 while injecting the replacement liquid during priming, and efficient cleaning and air bubble removal are possible.

  In the fluid replacement line 5, the pressure measuring means 23 is provided on a communication circuit between the fluid replacement line branch 5a and the blood pump 3 site or the opening / closing means 19 site between the arterial connection end A and the fluid replacement line branch 5a. The automatic blood return device described in any of the above. Providing the pressure measuring means 23 at the site of the replacement fluid line 5 is effective because it can prevent or estimate an abnormal pressure rise or pressure reduction and the current liquid supply state.

In the following, an embodiment of the present invention will be described in more detail with reference to the drawings.
1 to 5 show the general configuration and arrangement of an automatic blood return device, and the flow paths and directions of blood and replacement fluid in each stroke and each state. FIG. 1 is a schematic view showing a state in which hemodialysis is performed without performing a replacement fluid. In FIG. 1, the artery side (blood) circuit 1 starts from the artery side connection end A and ends at the dialyzer connection end A ′ connected to the hemodialyzer 2. The arterial circuit 1 is provided with a blood pump 3 and an arterial chamber 4 in this order from the upstream side, and a replacement fluid line branching portion 5a connected to the replacement fluid line 5 exists between the blood pump 3 and the artery side connection end A. A bubble sensor 6 is mounted between the branch portion 5a and the arterial connection end A. An opening / closing means 19 is provided between the replacement fluid branch 5a and the arterial connection end A.

  The replacement fluid line 5 starts from the replacement fluid container 7 serving as a replacement fluid supply source, and is provided in the range where an opening / closing means 18 is provided on the replacement fluid line 5 and ends at the replacement fluid line branch portion 5a. A pressure sensor 23 for measuring the pressure between the opening / closing means 18 on the replacement fluid line and the branch portion 5a is provided.

The venous side (blood) circuit 10 starts at the dialyzer 2 connection end B ′ and ends at the venous side connection end B. The venous circuit 10 is provided with a venous chamber 11, a bubble sensor 12, and a clamp 13 as an opening / closing means in order from the upstream side.
An overflow line 14 is connected to the upper portion of the venous chamber 11 to overflow or remove the cleaning liquid and bubbles at the time of liquid priming of the blood circuit. The overflow line 14 is provided with a clamp 15 that can open and close the line 14.

  The blood pump 3, the opening / closing means 18 on the replacement fluid line 5, the opening / closing means 19 on the arterial circuit 1, and the filtration / back-filtration third liquid feeding means P 1 provided in parallel with the dialysate perfusion line are: The communication path 17 communicates with the control device 16, and the control device 16 not only drives and stops the blood pump 3 and the filtration / back-filtration third liquid feeding means P <b> 1, but also the respective liquid feeding directions and liquid feeding amounts (flow velocity). Is controlled to be a predetermined value, or the ratio of the liquid supply amount of the blood pump 3, the filtration / back-filtration third liquid supply means P1 is a predetermined value. Further, the control device 16 connects the passage 13 so that the opening and closing of the clamp 13 attached to the venous circuit 10, the driving / stopping of the blood pump 3, the filtration / reverse filtration third liquid feeding means P1, and the flow rate adjustment can be controlled in conjunction. 17 is in contact.

Hereinafter, the state of each stroke and the blood feeding and feeding of the blood circuit in the stroke will be briefly described.
FIG. 1 shows a state where hemodialysis is performed without a replacement fluid operation. The open / close means 18 on the replacement fluid line 5 is closed, the open / close means 19 on the arterial circuit 1 is open, and only the blood pump 3 is rotating. The clamp 13 is open and the clamp 15 is closed. As the open / close means 18 on the replacement fluid line 5 is closed and blood does not flow through the replacement fluid line 5, the blood flowing into the artery side circuit 1 from the arterial connection end A is shown in FIG. 2 is passed through the venous circuit 10 and returned from the venous connection end B to the patient.

  Here, the clamp 15 is closed, and there is no fluid flow in the overflow line 14. Further, in each of the hemodialysis process, the replacement liquid process, and the blood return process described in this embodiment, the overflow line 14 is kept closed. The configuration is the same in each process.

  Next, the replacement fluid process will be described. When it is necessary to rapidly replace the fluid during hemodialysis due to reasons such as a decrease in blood pressure of the patient, the opening / closing means 18 on the replacement fluid line 5 is opened as shown in FIG. 19 is in a closed state. The replacement fluid is controlled by the flow rate of the blood pump 3. For example, if the flow rate of the blood pump 3 is 100 ml / min, the flow rate of the replacement fluid is 100 ml / min. If the flow rate of the blood pump 3 is 100 ml / min and the opening / closing means 19 on the arterial circuit 1 is closed, the blood flowing in from the arterial connection end A becomes 0 ml / min, and the replacement fluid flowing out from the replacement fluid line 5 Flows through the blood circuit. Furthermore, the amount of fluid replacement can be determined by setting the fluid replacement time.

  Next, the blood return process will be described. The control of the blood return process varies depending on the method, but only a representative one will be described here. As an example, the blood filled in the blood circuit 1 downstream from the replacement fluid branch 5a is first returned (FIG. 3), and then the blood circuit upstream from the replacement fluid branch 5a is filled. There is a mode of returning the blood (FIG. 4).

  In FIG. 3, the opening / closing means 18 on the replacement fluid line is opened, and the opening / closing means 19 on the arterial circuit 1 is controlled to be closed, and the blood downstream from the replacement fluid branch point 5a at the flow rate of the blood pump 3. The blood filled in the circuit is returned to the patient according to the direction of the arrow in FIG. When the blood completely flows out of the blood circuit 1 downstream from the replacement fluid branch 5a, the opening / closing means 18 on the replacement fluid line 5 is closed, and the opening / closing means 19 on the arterial circuit is opened. In conjunction with the switching (in conjunction with the opening and closing means 18 being closed and the opening and closing means 19 being switched to the open state): If this switching is not completed (unless switched normally) The reverse rotation of the pump 3 and the reverse filtration direction operation of the filtration / reverse filtration third liquid feeding means P1 are not performed.) The blood pump 3 is reversely rotated, and at the same time, the filtration / reverse filtration third liquid feeding means (filtration of the dialysate line) / Back filtration pump) P1 is operated in the back filtration direction. Then, as shown in FIG. 4, the blood remaining on the upstream side from the branch line 5 is returned to the patient from the artery side connection end A by the reverse filtrate that is reversely filtered from the dialyzer 2.

At this time, in FIG. 4, the clamp 13 may be interlocked and controlled by the control device 16 using the control device.
Further, in this blood return process, the blood pump 3 and the third filtration / back-filtration third liquid feeding means are controlled by the pressure measured by the pressure measuring means (the pressure sensor 9 or the pressure sensor 23), and the internal pressure in the blood circuit rises abnormally. It is possible to ensure safety by preventing this, or by issuing an alarm when the pressure becomes abnormally high and closing with an opening / closing means.

  Another example is as shown in FIG. That is, by making the flow rate of the filtration / reverse filtration third liquid feeding means P1 in the dialysate perfusion line larger than the flow rate of the blood pump 3 that is rotating in the reverse direction, the fluid replacement line branching section 5a is moved upstream and downstream. The remaining blood can be returned to the patient at the same time. That is, of the back filtrate that is back-filtered from the dialyzer 2 by the filtration / back-filtration third liquid feeding means P1, an amount equal to that of the blood pump 3 flows to the blood circuit 1 on the artery side, and the remaining (surplus) ) Flows through the blood circuit 10 on the venous side and is returned to the patient. With this method, blood can be returned via the artery side connection end A and the vein side connection end B at the same time, so that the operation can be completed in a short time.

  The automatic blood return device of the present invention can perform a blood return operation with high certainty that there is no contamination or medical error and no burden on the medical staff in the replacement operation during hemodialysis or the blood return operation after dialysis. Suitable for automatic blood return devices.

It is the schematic which shows an example of the automatic blood return apparatus of this invention, Comprising: The process is in process of hemodialysis. In FIG. 1, the schematic which shows the state which is performing the replacement fluid during hemodialysis. BRIEF DESCRIPTION OF THE DRAWINGS It is an example of the automatic blood return apparatus of this invention, Comprising: The schematic which shows one Embodiment of an automatic blood return process. It is an example of the automatic blood return apparatus of this invention, Comprising: The schematic which shows another embodiment of an automatic blood return process. 1 is a schematic diagram illustrating an embodiment of the automatic blood return device of the present invention, which simultaneously returns blood from an arterial circuit and a venous circuit. FIG.

Explanation of symbols

1. 1. Arterial blood circuit 2. hemodialyzer Blood pump 4. 4. Arterial chamber Fluid replacement line 5a: branch point 6. Bubble sensor 7. Replenisher container 8. 8. Fluid replacement pump Pressure sensor 10. 10. Venous blood circuit Venous chamber 12. Bubble sensor 13. Clamp 14. Overflow line 15. Clamp 16. Control device 17. Connecting way 18. Fluid replacement line clamp 19. Arterial line clamp 20. Dialysate supply line 21. Dialysate drainage line 22. Dialysate / filtration / back filtration line 23. Pressure sensor P1. Filtration / back filtration pump P2. Dialysate supply pump P3. Dialysate drainage pump P4. Slow water pump A. Arterial connection end A ′: dialyzer arterial connection end B. Venous side connection end B ': Dialyzer vein side connection end

Claims (6)

An arterial side (blood) circuit on the upstream side of the hemodialyzer, a venous side (blood) circuit on the downstream side, and a replacement fluid line for branching from the arterial side circuit and for supplying replacement fluid to the circuit. The line is provided with opening and closing means for opening and closing the replacement fluid line.
The arterial circuit includes an arterial connection end connected to a patient artery via a puncture means, a dialyzer connection end for connection to a hemodialyzer, and an arterial chamber provided between the both ends. , Blood supply means, and the fluid replacement line branch, the bubble detection means, the arterial side connection end and the fluid replacement line branch between the opening and closing means,
The venous side circuit has a dialyzer connection end and a venous side connection end for connection to a hemodialyzer, a venous chamber provided at an intermediate portion between the both ends, a bubble detection means, and an opening / closing means.
The replacement fluid line has a replacement fluid supply source,
The blood supply means (blood pump) provided on the arterial circuit side of the blood circulation system has a blood pump capable of forward / reverse rotation capable of flow rate control, and a dialysate supply line for perfusing the dialyzer and dialysate drainage A dialysis supply line and a dialysate drainage line, respectively, and the dialysate supply line or dialysate drainage line is subjected to filtration and reverse filtration in parallel with the liquid feed means. At least one filtration / reverse filtration third liquid feeding means and slow water draining means capable of forward / reverse rotation and flow rate control, and the blood feeding means and the third filtration / back filtration third feed The fluid means is a blood supply means, an opening / closing means for opening / closing the fluid supply means and the replacement fluid line, and an interlocking control means for controlling the opening / closing means between the arterial connection end and the replacement fluid line branching portion in conjunction with each other. Automatic characterized by being contacted Blood system. 2. The automatic blood return according to claim 1, wherein the venous circuit has an opening / closing means for opening and closing the venous circuit, the interlock control means being in communication with the opening / closing means, and the opening / closing means can also be interlocked. apparatus. By the interlock control means, the flow rate (flow velocity) of both the blood feeding means and the filtration / back-filtration third liquid feeding means is substantially equal, increased, or decreased depending on each process and situation. The automatic blood return apparatus according to claim 1, wherein the automatic blood return apparatus is capable of interlocking control. The automatic blood return apparatus according to any one of claims 1 to 3, wherein the venous chamber is provided with an overflow line for overflowing the liquid in the chamber, and an opening / closing means is attached to the overflow line. 5. The pressure measuring means is provided in the fluid replacement line on a communication circuit between the fluid replacement line branch portion and the blood feeding means portion or an opening / closing means portion between the arterial side connection end and the fluid replacement line branch portion. An automatic blood return device according to any one of the above. Blood supply means, liquid supply means, filtration / reverse filtration third liquid supply means, opening / closing means for opening / closing the replacement fluid line, and opening / closing means between the arterial connection end and the replacement fluid line branching portion by the blood circuit internal pressure by the pressure measuring means The automatic blood return device according to any one of claims 1 to 5, which can be controlled in conjunction with each other.

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