The present invention relates to a hemodialysis apparatus that is used for a medical treatment with an extracorporeal circulation of blood such as hemodialysis, hemodialysis filtration, or hemofiltration, and more particularly to a hemodialysis apparatus that can fundamentally solve such a problem that air is trapped in a mesh disposed in a vein side chamber CV during priming, and then remains therein.
A hemodialysis apparatus is a type of medical equipment that extracorporeally circulates blood of a patient with renal failure or a drug intoxicated patient to perform blood purification. The hemodialysis apparatus generally includes three portions of (1) a hemodialyzer D that brings blood into contact with a dialysate through a semipermeable membrane to purify blood, (2) a dialysate supply/discharge system mainly including a dialysate supply line L1 that supplies the dialysate to the hemodialyzer D, and a dialysate discharge line L2 that discharges the dialysate from the hemodialyzer D, and (3) a blood circuit mainly including an artery side blood line L3 that allows the blood drawn from the patient to flow into the hemodialyzer D, and a vein side blood line L4 that returns the blood drained from the hemodialyzer D to the patient.
In conducting the medical treatment using the above-mentioned hemodialysis apparatus, priming for washing the flow passages of the hemodialyzer D and a blood circuit including the artery side blood line L3, and the vein side blood line L4 by the aid of a normal saline or a dialysate is conducted as a preliminary process.
(First Process)
In a first process, as illustrated in
Then, the dialysate pushed into the hollow fiber within the hemodialyzer D through the reverse filtering operation due to the third fluid feeding means P3 flows, as illustrated in
Then, the dialysate that has flown in the vein side chamber CV accumulates in the vein side chamber CV illustrated in
As described above, in the first process, the dialysate that has been pushed into the hollow fiber within the hemodialyzer D through the reverse filtering operation due to the third fluid feeding means P3 flows in the flow passage extending from the connection portion between the hemodialyzer D and the vein side blood line L4 to the vein side chamber CV in the stated direction to prime the flow passage and the hemodialyzer D.
(Second Process)
In a second process, as illustrated in
Then, because the dialysate accumulates in the vein side chamber CV by priming made in the first process, the dialysate that has flown in the vein side chamber CV is discharged from the overflow line L5 as illustrated in
As described above, in the second process, the dialysate that has been pushed into the hollow fiber within the hemodialyzer D through the reverse filtering operation due to the third fluid feeding means P3 flows in the flow passage extending from the connection portion between the hemodialyzer D and the artery side blood line L3 to the vein side chamber CV through the blood pump P4 in the stated direction to prime the flow passage and the hemodialyzer D.
(Third Process)
In a third process, as illustrated in
As described above, in the third process, the dialysate that has been pushed into the hollow fiber within the hemodialyzer D through the reverse filtering operation due to the third fluid feeding means P3 flows both in the flow passage extending from the connection portion between the hemodialyzer D and the artery side blood line L3 to the vein side chamber CV through the blood pump P4 and in the flow passage extending from the connection portion between the hemodialyzer D and the vein side blood line L4 to the vein side chamber CV, so as to prime the both flow passages and the hemodialyzer D. The general operation of the priming method according to the conventional art using the dialysate is described above.
Incidentally, the mesh disposed in the vein side chamber CV is made of a hydrophobic material, and hence if the mesh is once wetted with the dialysate, air may hardly pass through the mesh due to surface tension. For that reason, in the above-mentioned priming method, after the mesh disposed in the vein side chamber CV is wetted in the first process illustrated in
If the air remains in the extracorporeal circulation circuit, there is a risk of air entrainment into a body of the patient during a medical treatment with an extracorporeal circulation of blood such as hemodialysis, hemodialysis filtration, or hemofiltration. For that reason, in the priming method according to the conventional art, in the processes illustrated in
However, from the viewpoint of providing a safe medical treatment with no accident to the patient, it is desirable to fundamentally solve the phenomenon in which the air is trapped in the mesh disposed in the vein side chamber CV rather than a coping process of removing the trapped air ex-post facto assuming that the air is trapped in the mesh disposed in the vein side chamber CV.
A problem to be solved by the present invention is to fundamentally solve a problem in that air is trapped in a mesh disposed in a vein side chamber CV during priming, and remains therein, and to provide a hemodialysis apparatus which can prevent beforehand any medical accident caused by air entrainment during a medical treatment with an extracorporeal circulation of blood such as hemodialysis, hemodialysis filtration, or hemofiltration.
The inventor of the present invention has attained a hemodialysis apparatus that can fundamentally solve the above-mentioned problem as a result of repeating various experimental studies and logical studies for solving the above-mentioned problem. The summary is described below.
(1) A hemodialysis apparatus, including: a hemodialyzer (D) of a wet type; a dialysate supply line (L1) that supplies a dialysate to the hemodialyzer (D); a dialysate discharge line (L2) that discharges the dialysate from the hemodialyzer (D); an artery side blood line (L3) that allows blood drawn from a patient to flow into the hemodialyzer (D); a vein side blood line (L4) that returns the blood drained from the hemodialyzer (D) to the patient; first fluid feeding means (P1) disposed in the dialysate supply line (L1); second fluid feeding means (P2) disposed in the dialysate discharge line (L2); third fluid feeding means (P3) that can rotate reversibly and is disposed in a bypass line that communicates an upstream side and a downstream side of any one or both of the first fluid feeding means (P1) and the second fluid feeding means (P2) with each other; a blood pump (P4) disposed in the artery side blood line (L3); a vein side chamber (CV) including a mesh, disposed in the vein side blood line (L4); an overflow line (L5) connected to the vein side chamber (CV); and control means (G1) that conducts, in the stated order: (A) a process in which the blood pump (P4) reversely rotates at the same speed as a reverse filtration speed made by the third fluid feeding means (P3), and the dialysate that has been pushed into a hollow fiber within the hemodialyzer (D) through a reverse filtering operation made by the third fluid feeding means (P3) flows in a first flow passage extending from a connection portion between the hemodialyzer (D) and the artery side blood line (L3) to the vein side chamber (CV) through the joint portion in a loop formed by connecting the artery side blood line (L3) and the vein side blood line (L4), to thereby prime the first flow passage and the hemodialyzer (D); and (B) a process in which a reverse rotation speed of the blood pump (P4) is made lower than the reverse filtration speed made by the third fluid feeding means (P3), and the dialysate of a flow rate corresponding to a speed obtained by subtracting the reverse rotation speed of the blood pump (P4) from the reverse filtration speed made by the third fluid feeding means (P3) flows in a second flow passage extending from a connection portion between the hemodialyzer (D) and the vein side blood line (L4) to the vein side chamber (CV), which is a remaining flow passage of the loop, to thereby prime the second flow passage and the hemodialyzer (D).
(2) A hemodialysis apparatus, including: a hemodialyzer (D) of a wet type or a dry type; a dialysate supply line (L1) that supplies a dialysate to the hemodialyzer (D); a dialysate discharge line (L2) that discharges the dialysate from the hemodialyzer (D); an artery side blood line (L3) that allows blood drawn from a patient to flow into the hemodialyzer (D); a vein side blood line (L4) that returns the blood drained from the hemodialyzer (D) to the patient; first fluid feeding means (P1) disposed in the dialysate supply line (L1); second fluid feeding means (P2) disposed in the dialysate discharge line (L2); third fluid feeding means (P3) that can rotate reversibly and is disposed in a bypass line that communicates an upstream side and a downstream side of any one or both of the first fluid feeding means (P1) and the second fluid feeding means (P2) with each other; a blood pump (P4) disposed in the artery side blood line (L3); a vein side chamber (CV) including a mesh, disposed in the vein side blood line (L4); an overflow line (L5) connected to the vein side chamber (CV); and control means (G2) that conducts a process in which the blood pump (P4) forwardly rotates at a speed lower than a reverse filtration speed made by the third fluid feeding means (P3), and the dialysate that has been pushed into a hollow fiber within the hemodialyzer (D) through a reverse filtering operation made by the third fluid feeding means (P3) circulates in a loop formed by connecting the artery side blood line (L3) and the vein side blood line (L4), which extends from a connection portion between the hemodialyzer (D) and the vein side blood line (L4) to a connection portion between the hemodialyzer (D) and the artery side blood line (L3) through the vein side chamber (CV), to thereby prime the flow passages and the hemodialyzer (D).
(1) According to the hemodialysis apparatus including the control means G1 according to the present invention, as the first process as illustrated in
In this example, because the air within the first flow passage passes through the mesh disposed in the vein side chamber CV earlier than the dialysate, the air is not trapped in the mesh.
Then, as illustrated in
As illustrated in
That is, the hemodialysis apparatus including the control means G1 which conducts the first process and the second process in the stated order according to the present invention can fundamentally solve a problem in that the air is trapped in the mesh disposed in the vein side chamber CV during priming, and remains therein, thereby enabling the medical accident caused by the air entrainment during the medical treatment to be prevented beforehand.
(2) According to the hemodialysis apparatus including the control means G2 according to the present invention, as illustrated in
As described above, if the air is allowed to pass through the mesh disposed in the vein side chamber CV after the mesh is wetted with the dialysate, the air is trapped in the mesh. However, the mesh is wetted with the dialysate for the first time in a phase of
In a phase where the air that has been trapped in the mesh passes through the joint portion of the vein side blood line L4 and the artery side blood line L3, the blood pump P4, and the artery side blood line L3, and flows into the hemodialyzer D, the dialysate of a sufficient amount to be discharged from the overflow line L5 accumulates in the vein side chamber CV. For that reason, the air that flows into the vein side chamber CV does not reach the mesh disposed in the vein side chamber CV due to the buoyancy of the dialysate that has accumulated in the vein side chamber CV as illustrated in
That is, the hemodialysis apparatus including the control means G2 according to the present invention can fundamentally solve a problem in that the air is trapped in the mesh disposed in the vein side chamber CV during priming, and remains therein, even when the hemodialyzer D of the dry type is used, thereby enabling the medical accident caused by air entrainment during the medical treatment to be prevented beforehand.
First, a hemodialysis apparatus according to a first embodiment of the present invention is described. Hereinafter, the hemodialysis apparatus according to the first embodiment of the present invention is referred to as “first embodiment”.
The first embodiment is a hemodialysis apparatus including a hemodialyzer D of a wet type.
The first embodiment is characterized in flow passage selection and a washing direction of the priming solution (dialysate) due to control means G1, which is described.
(First Process)
In a first process, as illustrated in
The reverse rotation means rotation in a direction opposite to a direction (forward rotation direction) along which the blood pump P rotates during a dialysis treatment.
The dialysate that has been pushed into the hollow fiber within the hemodialyzer D through the reverse filtering operation made by the third fluid feeding means P3 flows in a first flow passage extending from a connection portion between the hemodialyzer D and an artery side blood line L3 to a vein side chamber CV through a junction portion in a loop formed by connecting the artery side blood line L3 and a vein side blood line L4 in the stated direction at 200 ml/min which is the same rate as the flow rate of the reverse filtration as illustrated in
In this example, because the air within the first flow passage passes through a mesh disposed in the vein side chamber CV earlier than the dialysate, the air is not trapped in the mesh. That is, because the mesh disposed in the vein side chamber CV is made of a hydrophobic material, if the air passes through the mesh wetted with the dialysate, the air is trapped in the mesh by surface tension action. However, in this process, as illustrated in
Then, the dialysate that has flown into the vein side chamber CV accumulates in the vein side chamber CV as illustrated in
As described above, in the first process, the blood pump P4 reversely rotates at the same speed as the reverse filtration speed made by the third fluid feeding means P3 so that the dialysate that has been pushed into the hollow fiber within the hemodialyzer D through the reverse filtering operation made by the third fluid feeding means P3 flows in the first flow passage in the above-mentioned direction, to thereby prime the flow passage and the hemodialyzer D.
When the blood pump P4 reversely rotates at a speed higher than the reverse filtration speed made by the third fluid feeding means P3, the flow rate of the dialysate that flows in the first flow passage is the same as that when the blood pump P4 reversely rotates at the same speed as the reverse filtration speed made by the third fluid feeding means P3. However, the air is pulled into the hemodialyzer D from the vein side blood line L4, which is undesirable.
On the other hand, when the blood pump P4 reversely rotates at a speed lower than the reverse filtration speed made by the third fluid feeding means P3, the dialysate also flows in the second flow passage extending from the connection portion between the hemodialyzer D and the vein side blood line L4 to the vein side chamber CV in the stated direction. For example, when the reverse rotation speed of the blood pump P4 is set to 100 ml/min in
That is, it is most desirable that the reverse rotation speed of the blood pump P4 be the same as the reverse filtration speed made by the third fluid feeding means P3. However, the speed lower than the reverse filtration speed made by the third fluid feeding means P3 is not completely excluded. Even if the speed is lower than the reverse filtration speed made by the third fluid feeding means P3, when such a speed is a speed at which the dialysate from the second flow passage flows into the vein side chamber CV after the removal of the air from the first flow passage has been completed, that is, after all of the air from the first flow passage has passed through the mesh disposed in the vein side chamber CV, the object of the first embodiment can be achieved.
(Second Process)
In a second process, as illustrated in
Then, because the dialysate has accumulated in the vein side chamber CV by priming in the first process, the air and the dialysate that flow into the vein side chamber CV are discharged from the overflow line L5 as illustrated in
The air within the second flow passage flows into the vein side chamber CV earlier than the dialysate as illustrated in
As described above, in the second passage, the dialysate that has been pushed into the hollow fiber within the hemodialyzer D through the reverse filtering operation made by the third fluid feeding means P3 flows into both of the first flow passage and the second flow passage, to thereby prime those flow passages and the hemodialyzer D.
The general operation of the first embodiment including the control means G1 which conducts the first process and the second process in the stated order is described above. According to the first embodiment, such a problem that the air is trapped in the mesh disposed in the vein side chamber CV during priming, and remains therein, may be fundamentally solved, thereby enabling the medical accident caused by the air entrainment during the medical treatment to be prevented beforehand.
It should be noted that in the second process described above, as illustrated in
However, in this case, because the air that flows into the vein side chamber CV from the second flow passage cannot obtain the upward flow of the dialysate that flows in the first flow passage, the air that flows into the vein side chamber CV reaches a deeper portion of the vein side chamber CV than that when the dialysate flows in both of the first flow passage and the second flow passage. For that reason, when the blood pump P4 stops so that, the dialysate flows only in the second flow passage, the reverse filtration speed made by the third fluid feeding means P3 should be decreased from the viewpoint of decreasing the inflow speed of the air that flows into the vein side chamber CV from the second flow passage.
As to a transition moment from the first process to the second process, it is desirable to transition to the second process at a moment when the dialysate that has washed the first flow passage in the first process as illustrated in
Further, when the dialysate from the second flow passage flows into the vein side chamber CV after all of the air within the first flow passage has passed through the mesh disposed in the vein side chamber CV, the air within the first flow passage is not trapped in the wetted mesh. Therefore, it is possible to transition to the second process at a moment when the dialysate flows into the vein side chamber CV from the first flow passage.
Alternatively, the amount of dialysate necessary to prime the hemodialysis apparatus, that is, the amount of dialysate necessary to wash the flow passages of the hemodialyzer D and the blood circuit including the artery side blood line L3 and the vein side blood line L4 is managed according to the reverse filtration speed and the period of time made by the third fluid feeding means P3, and that information is saved in given recording means such as a memory or a hard disk. The hemodialysis apparatus automatically starts priming according to priming start information from a healthcare professional, for example, upon pressing a priming start button disposed in the hemodialysis apparatus, and operates the third fluid feeding means P3 based on the reverse filtration speed and the period of time which have been saved in the recording means. Accordingly, from the viewpoint of controllability, it is possible that a period of time when the dialysate that has washed the first flow passage is discharged from the overflow line L5, or a period of time when the dialysate flows into the vein side chamber CV from the first flow passage is calculated in advance, the calculated period of time is saved in given recording means such as a memory or a hard disk in advance, and the transition to the second process is performed after the calculated period of time has elapsed from a time point when the priming start button has been pressed. With application of this method, an intervention of the healthcare professional is not required, and the transition to the second process may be automatically performed.
Subsequently, a hemodialysis apparatus according to a second embodiment of the present invention is described. Hereinafter, the hemodialysis apparatus according to the second embodiment of the present invention is referred to as “second embodiment”.
The second embodiment is a hemodialysis apparatus including a hemodialyzer D of the wet type or the dry type.
The second embodiment is also characterized in the flow selection and the washing direction of the priming solution due to the control means G2, which is described.
According to the second embodiment, as illustrated in
As illustrated in
It should be noted that, a case, in which the hemodialyzer D of the wet type is used, is different from the above-mentioned case, and means that all of the air existing in the flow passage has been pushed out by the dialysate.
The reason that the dialysate flows in the flow passage at the flow rate of 200 ml/min although the blood pump P4 forwardly rotates at 160 ml/min is that the dialysate of 200 ml/min which has been pushed into the hollow fiber by the reverse filtration operation made by the third fluid feeding means P3 has nowhere to go other than the flow passage extending from the connection portion between the hemodialyzer D and the vein side blood line L4 to the vein side chamber CV because the blood pump P4 forwardly rotates.
If the completion of the air removal from the flow passage, the dialysate that has been pushed into the hollow fiber within the hemodialyzer D through the reverse filtration operation made by the third fluid feeding means P3, and the air that has been pushed out of the hemodialyzer D of the dry type flow into the vein side chamber CV as illustrated in
That is, as described above, when the air passes through the mesh after the mesh disposed in the vein side chamber CV has been wetted with the dialysate, the air is trapped in the mesh. However, the mesh is wetted with the dialysate for the first time in a phase of
The dialysate and the air that have been pulled into the vein side blood line L4 from the vein side chamber CV by the forward rotate operation of the blood pump P4 are still pulled into the blood pump P4 at 160 ml/min as illustrated in
The air that flows in the vein side chamber CV in this phase means the air that has originally existed in the hemodialyzer D of the dry type, and the air that has been pulled out of the vein side chamber CV when the dialysate has not reached the vein side chamber CV, and pushed into the hemodialyzer D by the blood pump P4. The air also includes air that has trapped in the mesh and then flown into the hemodialyzer D.
As described above, in the phase illustrated in
Further, the dialysate and the air flow into the vein side chamber CV at 360 ml/min while the dialysate is pulled out of the vein side chamber CV at 160 ml/min. Therefore, the dialysate and the air are discharged from the overflow line L5 at 200 ml/min which is a difference therebewteen.
As described above, because the air that flows into the vein side chamber CV is continuously discharged from the overflow line L5, the air is reduced every time the dialysate is circulated as illustrated in
That is, the second embodiment forwardly rotates the blood pump P4 to circulate the dialysate that has been pushed into the hollow fiber within the hemodialyzer D through the reverse filtering operation made by the third fluid feeding means P3 in the loop in the stated direction, to thereby prime the flow passage and the hemodialyzer D.
The general operation of the second embodiment is described above. According to the second embodiment, needless to say the hemodialyzer D of the wet type, even when the hemodialyzer D of the dry type is used, such a problem that the air is trapped in the mesh disposed in the vein side chamber CV during priming, and remains therein, may be fundamentally solved, thereby enabling the medical accident caused by the air entrainment during the medical treatment to be prevented beforehand.
As described above, in the second embodiment, the air that has flown into the vein side chamber CV goes up in the dialysate due to the buoyancy of the dialysate that has accumulated in the vein side chamber CV as illustrated in
However, in the second embodiment, because the upward flow of the dialysate cannot be obtained unlike the first embodiment, the air that has flown into the vein side chamber CV reaches a deeper portion of the vein side chamber CV than that in the first embodiment. That is, in the case of the first embodiment, because the blood pump p4 reversely rotates as illustrated in
Accordingly, a performance that pulls the air from the lower side of the vein side chamber CV is determined according to the flow rate of the blood pump P4. Therefore, it is desirable to determine the flow rate of the blood pump P4 so that the buoyancy of the dialysate that has accumulated in the vein side chamber CV exceeds a pulling force from the lower side of the vein side chamber CV, and the air that has flown into the vein side chamber CV does not reach the mesh, taking the flow rate flowing into the dialysate that has accumulated in the vein side chamber CV, the depth of the vein side chamber CV, and the shape and arrangement of the mesh into consideration.
It is desirable that the hemodialyzer D that brings blood into contact with the dialysate through a semipermeable membrane to purify the blood be of a hollow fiber type.
It is desirable that the dialysate supply line L1 that supplies the dialysate to the hemodialyzer D and the dialysate discharge line L2 that discharges the dialysate from the hemodialyzer D each be formed of a silicon tube.
Further, it is desirable that the artery side blood line L3 that allows the blood drawn from the patient to flow into the hemodialyzer D and the vein side blood line L4 that returns the blood drained from the hemodialyzer D to the patient each be made of a flexible chemosynthetic material.
It is desirable that the first fluid feeding means P1 that feeds the dialysate to the hemodialyzer D, and the second fluid feeding means P2 that sucks the dialysate from the hemodialyzer D each be formed of a diaphragm pump or a duplex pump.
Further, it is desirable that the blood pump 4 that circulates the blood and the like be formed of a roller tubing pump.
It is desirable that the third fluid feeding means P3 that moves the dialysate into the blood circuit by reverse filtration through the hemodialyzer D, and removes the blood within the hemodialyzer D be formed of a reversible metering pump.
In the above-mentioned first and second embodiments, the third fluid feeding means P3 is disposed in the bypass line that communicates the upstream side and the downstream side of the second fluid feeding means with each other. However, the present invention is not limited to this configuration.
In
In
It is desirable that the vein side chamber CV disposed in the vein side blood line L4 be made of a flexible chemosynthetic material.
Further, it is desirable that in the overflow line L5 connected to the vein side chamber CV be made of a flexible chemosynthetic material.
The above-mentioned first and second embodiments each includes only the vein side chamber CV. Alternatively, an artery side chamber CA may be disposed as illustrated in
Further, the shape and arrangement of the mesh disposed in the vein side chamber CV are not limited to the embodiments in which a mesh convex in the upward direction is disposed on the lower portion of the vein side chamber CV as illustrated in
It is desirable that the control means G1 that conducts control for reversely rotating the blood pump P4 at the same speed as the reverse filtration speed of the third fluid feeding means P3 recorded in given recording means based on this reverse filtration speed upon inputting the priming start information from the healthcare professional in the first process of the first embodiment, control for automatically transitioning to the second process based on the reverse filtration time of the third fluid feeding means P3 recorded therein, and control for controlling the reverse rotation speed of the blood pump P4 to a predetermined speed lower than the reverse filtration speed made by the third fluid feeding means P3 to complete the priming after a recorded given period of time has elapsed, be formed of a computer (electronic computer).
Likewise, it is desirable that the control means G2 that conducts control for forwardly rotating the blood pump P4 at a speed lower than the reverse filtration speed of the third fluid feeding means P3, which is also a predetermined speed recorded in given recording means, upon inputting the priming start information from the healthcare professional in the second embodiment, and control for completing the priming after a predetermined given period of time has elapsed, be formed of a computer (electronic computer).
Number | Date | Country | Kind |
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2007-305528 | Nov 2007 | JP | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/JP2008/070955 | 11/18/2008 | WO | 00 | 5/18/2010 |