JP6057628B2 - Priming method for artificial dialysis machine - Google Patents

Description

The present invention relates Puraimin grayed how by dialysate arteriovenous circuit through the dialyzer for hemodialysis machines.

  Generally, in an artificial dialysis apparatus, a priming process is performed before hemodialysis is performed on a patient. This priming process introduces and fills the priming solution into the arteriovenous circuit including the dialyzer, thereby removing air and foreign matter in the circuit and detecting defects such as leakage and breakage in the circuit. To do. Conventionally, physiological saline has been used as a priming solution for this priming treatment. However, since a large amount of physiological saline is consumed, in recent years, in order to reduce costs, dialysate is used instead of physiological saline. A method using the method (for example, Patent Documents 1 to 3) is spreading.

  In the priming process using the dialysate, for example, as shown in FIG. 1, the end a of the arterial blood circuit L1 connected to the dialyzer D and the end b of the venous blood circuit L2 are connected to form a blood circuit loop L. The dialysate formed and supplied from the dialysate line L3 is back-filtered by the dialyzer D, and this back-filtered dialysate is circulated to the blood circuit loop L by the blood pump P. The air expelled from the blood circuit loop L and excess dialysate are discharged from a discharge line L4 extending out of the loop from the vein chamber C2 interposed in the vein-side blood circuit L2. Is discharged by a drainage funnel 1 at the inlet of the drainage line L5 disposed further downward, and drains through the bed under the treatment room via the check valve 3 at the end of the tube 2 constituting the drainage line L5. It flows out to the drain hole 4a of the pipe 4. In the figure, C1 denotes an artery side chamber, and M denotes a patient monitoring device (console).

Japanese Patent No. 3302520 JP 2004-187990 A JP 2007-167107 A

  However, since the water washing process applied to the dialysate line L3 does not extend to the drain line L5 of another circuit, when dialysate is used as the priming solution, calcium carbonate is derived from the calcium component contained in the dialysate. The calcium carbonate adheres to and accumulates on the inner periphery of the tube 2 and the periphery of the check valve 3, eventually resulting in blockage of the line and malfunction of the valve. In addition to incurring a situation overflowing from the funnel 1, it is feared that germs will propagate using the sugar contained in the dialysate as a nutrient source. Thus, the tube 2 has a shape in which the downstream side of the upstream vertical line portion 2a that hangs down from the drainage funnel 1 runs along the floor surface as a horizontal line portion 2b. Accumulation of calcium carbonate is conspicuous due to the stay of the drainage flowing into the liquid line L5. Therefore, in the priming method using the dialysate, it is necessary to perform acid cleaning for the drainage line L5. However, in addition to requiring a lot of labor and time for the work, human, time and cost in dialysis treatment are also required. It is also difficult to clean every time due to restrictions.

  In view of the above circumstances, the present invention reliably prevents the adhesion and accumulation of calcium carbonate at a low cost with little effort and time for a priming drainage line using dialysis fluid. An object of the present invention is to provide an extremely simple means capable of removing accumulated calcium carbonate.

In order to achieve the above object, an artificial dialysis device priming method according to the first aspect of the present invention includes an arterial blood circuit and a venous blood in priming with a dialysate in an arteriovenous blood circuit including a dialyzer of the artificial dialysis device. The dialysate is supplied to the blood circuit loop connecting the ends of the circuit and back-filtered by a dialyzer, and the dialyzed solution filtered back is circulated to the blood circuit loop by a blood pump and driven out of the blood circuit loop. A drainage funnel provided on the inlet side of the drainage line is disposed in the discharge part of the air and surplus dialysate outside the loop, and the drainage for priming is formed by tableting acid agent powder into the drainage funnel. The treatment tablet is loaded, and the dialysate flowing into the drainage funnel from the discharge part is brought into contact with the drainage treatment tablet and discharged to the drainage channel outside the system through the drainage line.

As a preferred embodiment of the priming method of claim 1, in the invention of claim 2, the volume of the draining tablet for priming is 1 to 50 cm ³ , and 2 to 5 tablets are loaded into the draining funnel. In the invention of claim 3, the drainage line is composed of a flexible tube, a check valve is interposed at the end thereof, the drainage line is composed of a flexible tube, and the check valve is provided at the end thereof. In the invention of claim 4, the priming drain is arranged such that the upstream side forms a vertical line portion depending from the drainage funnel and the downstream side forms a horizontal line portion along the floor surface. Liquid-treated tablets are prepared by blending a disinfectant and anhydrous sodium sulfate as an excipient into an acid agent powder composed mainly of at least one selected from maleic acid, malonic acid, succinic acid, and sulfamic acid. Na A configuration is adopted, respectively.

According to the priming method of the artificial dialysis device according to the first aspect of the present invention , in priming using dialysis fluid as the priming fluid , the priming wastewater is formed by compressing the acid agent powder into the drainage funnel at the inlet of the drainage line. Since the liquid-treated tablet is loaded , the tablet is dissolved by the dialysate discharged into the drainage funnel, and the dialysate itself is acidified . Therefore, the calcium contained in the dialysate does not adhere or accumulate as calcium carbonate around the inner periphery of the tube of the drainage line or around the check valve, and the drainage line is blocked due to the adhesion or accumulation of calcium carbonate. No malfunction of the valve or valve occurs, and the propagation of germs using the sugar contained in the dialysate as a nutrient source is also suppressed. Even if the priming drainage line has already adhered and accumulated calcium carbonate, if the tablet is loaded in the drainage funnel, the calcium carbonate that has adhered and accumulated at each subsequent priming will be affected by the acid. Since the amount of adhesion / accumulation gradually decreases after dissolution, calcium carbonate can be removed almost completely after a certain number of priming cycles.

According to the invention of claim 2, in the above priming method, since a specific number of drainage processing tablets of a specific size is loaded in the drainage funnel, the dialysate discharge position in the drainage funnel is concerned. Instead, the dialysate is surely brought into contact with the tablet and dissolved.

According to the invention of claim 3, the drainage line is composed of a flexible tube having a check valve at the end, and the drainage is retained in the horizontal line portion on the downstream side. Calcium carbonate does not adhere and accumulate as calcium carbonate around the inner periphery of the horizontal line of the tube or around the check valve, causing drainage line blockage or valve malfunction due to adhesion or accumulation of calcium carbonate. Does not occur.

According to the invention of claim 4, since the draining tablet for priming contains the disinfectant and the specific excipient in the specific acid agent powder, the tableting / molding property and shape retention are good, and the tablet production In addition to improving the yield, it exhibits an appropriate solubility in the dialysis solution, and therefore it is possible to continuously exhibit an excellent calcium carbonate precipitation preventing action and a good dissolving action on existing calcium carbonate .

It is a flow-path block diagram which shows an example of the priming process by a dialysate. It is a perspective view which shows one form of the drainage processing tablet for priming which concerns on this invention. 1 shows a drainage funnel portion of a priming drainage line to which the present invention is applied, (a) is a perspective view of the entire drainage funnel, and (b) is a discharge of dialysate into a drainage funnel loaded with a drainage treatment tablet. FIG. 5C is a longitudinal side view showing the state, and FIG. 5C is a plan view showing the inside of the drainage funnel loaded with the drainage treatment tablet.

  As described above, the draining tablet for priming according to the present invention is obtained by compressing and molding an acid agent powder, and during the priming process using a dialysate in an arteriovenous circuit including a dialyzer of an artificial dialyzer. The dialysis fluid is dissolved in the dialysis fluid discharged into the drainage funnel by being charged in the drainage funnel that constitutes the inlet portion of the drainage line. In addition to preventing the precipitation of calcium carbonate in the water, it also suppresses the growth of germs that use the sugar contained in the dialysate as a nutrient source, and also dissolves and removes calcium carbonate already present in the drainage line. To do.

  As an acid agent used for this drained tablet, it can be used as long as it is powdery at normal temperature (25 ° C.) and the aqueous solution shows acidity. In this case, it is preferable to use a material that does not generate precipitates or insoluble materials, is excellent in solubility of calcium carbonate, and has good tableting moldability. From these viewpoints, it is recommended that at least one selected from maleic acid, malonic acid, succinic acid, and sulfamic acid be the main component. The reason why a moderate solubility in the dialysate is required is that if the solubility is too high, it is consumed uneconomically, whereas if the solubility is too low, the use effect is insufficient.

  In addition, as the drainage-treated tablet, a disinfectant may be added to the acid agent powder in order to further enhance the effect of suppressing the propagation of various bacteria. Such a disinfectant is not particularly limited as long as it is in a powder form. For example, potassium peroxosulfate, parachlorometaxylenol, benzalkonium chloride and the like can be used. In addition, it is good for the compounding quantity of a disinfectant to be about 0.1-5 weight part with respect to 100 weight part of acidic agent powder from the surface of the bactericidal action and economical efficiency.

  Further, the drainage-treated tablet may contain an excipient for improving its tableting moldability. The excipient may be any excipient as long as it does not inhibit the solubility of the tablet in the dialysate and does not produce precipitates or insolubilized materials when dissolved in the dialysate, but anhydrous sodium sulfate is particularly preferred. is there. In addition, the blending amount of the excipient is preferably about 10 to 80 parts by weight with respect to 100 parts by weight of the acid agent powder from the viewpoint of sterilization action and economy.

The size of the drained tablet is not particularly limited, but the tablet volume is preferably in the range of 1 to 50 cm ³ . If this size is too small, it becomes difficult to stay in the drainage funnel in addition to the quick consumption. On the other hand, if the size is too large, it will be difficult to load a plurality of tablets into the drainage funnel, and even if the dialysate contact part melts and becomes a hole, it will not move in the drainage funnel. There is a concern that the tablet components will not dissolve just by passing the dialysate through the. In addition, although there is no restriction | limiting in particular also about the form of a drainage processing tablet, A cylindrical form like the tablet T shown in FIG. 2 is easy to tablet. In the case of this cylindrical shape, the diameter φ is preferably about 15 to 40 mm, and the thickness t is preferably about 5 to 30 mm.

  An example of the drainage funnel of the priming drainage line in which such drainage processing tablets are loaded is shown in FIG. The drainage funnel 1 includes a substantially cylindrical funnel body 11 opened upward and a substantially annular tube retaining frame 12 fitted to the upper edge of the funnel body 11. It consists of two members. The funnel body 11 is provided with a short tube-shaped tube connecting portion 11a at the tapered lower end, and an annular rib 11b is formed on the outer periphery of the upper portion. As shown in FIG. In a state where the end of the tube 2 of the drainage line is connected to the portion 11a, the tube is fitted to the support ring 7 on the patient monitoring device side and hooked by the annular rib 11b. Moreover, the tube latching frame 12 has a plurality of strips (four strips in the figure) in which the latching portion 12b rises from a part of the circumference of the annular portion 12a and steeply inclines from the outside to the upper end of the latching portion 12b. As shown in FIG. 3B, the end side of the discharge tube 5 (which constitutes the discharge line L4 in FIG. 1) is fitted into and latched into the hook groove 13 as shown in FIG. The discharge port 5 a of the discharge tube 5 is positioned at an appropriate height in the funnel body 11.

  In the priming method of the present invention, as shown in FIGS. 3 (b) and 3 (c), a plurality of the drainage-treated tablets T having a cylindrical shape shown in FIG. Lock). Reference numeral 6 denotes a receiving material made of a spiral wire, which prevents the tablet T from fitting into the flow-down port 10.

  If a plurality of the drainage treatment tablets T are loaded in the drainage funnel 1 in this way, even if the position of the discharge port 5a of the discharge tube 5 varies with each processing, it is discharged from the discharge port 5a. Since the dialysate is always in contact with the drainage-treated tablet T and flows down, the acidic agent of the tablet T dissolves in the dialysate, and the above-described effects can be reliably exhibited.

  In FIG. 1, the dialysis fluid used for priming is supplied from the dialysis fluid line L3 and is reversely filtered by the dialyzer D and circulated through the blood circuit loop L. However, the conventional physiological saline for priming is used. As described above, a system in which a container such as a bag or a tank is supplied to the blood circuit loop L may be supplied.

[Manufacture of drained tablets]
A powder mixture obtained by adding a disinfectant and an excipient to an acid agent powder at the blending ratio shown in Table 1 below is used as a raw material, and tableting is performed by a tableting machine, and the columnar shape is 20 mm in diameter and 8 mm in thickness. Drained tablets T1 to T12 weighing about 5 g were manufactured.

  The manufactured drainage-treated tablets T1 to T12 were tested for the following items: tablet shape retention, tablet solubility, insoluble component generation upon dissolution, calcium carbonate solubility, and sterilization effect. It describes. The test method and evaluation for each item are as follows.

<Tablet moldability>
The shape retention as a tablet after tableting was observed and evaluated in the following four stages.
◎ ... Hard and does not lose shape.
○ ... Slightly brittle, but with shape retention that can be used.
Δ: Easy to collapse and poor shape retention.
×: Tableting is difficult and yield as a tablet is poor.

<Dissolution of tablets>
A dialysate (trade name Kindery AF-2S manufactured by Fuso Yakuhin Kogyo Co., Ltd.) is poured into a drainage funnel loaded with 3 tablets (total 15 g) for 5 minutes (total flow rate: 1 L). The tablet component concentration in the dialysate was measured and evaluated in the following four stages.
A: Tablet component concentration of 0.3% by weight or more to less than 1.0% by weight → moderate solubility.
○: Tablet component concentration 1.0% by weight or more → Excessive dissolution due to excessive dissolution.
Δ: Tablet component concentration of 0.1 to 0.3% by weight → Insufficient dissolution.
×: Tablet component concentration of less than 0.1% by weight → Poor use effect.

<Insoluble component generation during dissolution>
Each tablet was dissolved at a concentration of 0.5% by weight in dialysate (Kindaly AF-2S: supra), 0.5 g / L calcium carbonate was added to this solution and stirred, and left for 24 hours. The state of the solution was visually observed and evaluated in the following three stages.
○ ... No insoluble material is observed.
Δ: Slightly insoluble matter is observed.
X: Considerable insoluble matter is observed.

<Calcium carbonate solubility>
Each tablet was dissolved in a dialysate (Kindaly AF-2S: supra) at a concentration of 0.5% by weight, and the amount of calcium carbonate dissolved in this solution was measured and evaluated in the following three stages.
○: Dissolved amount of 1.0 g / L or more.
Δ: Dissolved amount of 0.5 g / L or more and less than 1.0 g / L.
X: Dissolution amount is less than 0.5 g / L.

<Sterilization>
Dissolved tablets in powder form are dissolved in dialysate (above) at a concentration of 0.5% by weight. Bacteria and mold are added to this solution and stored in a 40 ° C incubator. Bacteria and mold agar medium in a sterile petri dish was smeared and maintained at 37 ° C. for bacteria and 28 ° C. for mold for 48 hours, and then the presence or absence of growth of bacteria and mold on the medium was observed.
○ ... Sterilization effect.
X: No sanitization effect.

  As is apparent from the above table, succinic acid, maleic acid, malonic acid, and sulfamic acid are suitable as the acidic agent used in the drained tablet, and it is particularly recommended that succinic acid be the main component. However, malic acid is hard to be formed as a tablet due to its hygroscopicity, and citric acid is inferior in shape retention as a tablet and is insoluble (presumed to be a reprecipitate of calcium carbonate) when added to dialysate. In addition, tartaric acid and oxalic acid are found to have poor solubility in calcium carbonate.

[Priming machine test 1]
Regarding the drainage line for priming using the dialysate of an artificial dialysis machine (trade name TR-3000MA manufactured by Toray Industries, Inc.) in operation by requesting the medical institution A performing artificial dialysis treatment, the drainage treatment of the present invention When the calcium carbonate adhesion / removal test was performed depending on whether the tablet was used or not, the results shown in Table 2 below were obtained. The operating conditions for dialysis and priming and the test conditions are as follows.

<Operating conditions for dialysis and priming>
Dialysis operation cool ... Almost 2 cools / day Priming fluid: Dialysis fluid: Brandy 3E manufactured by Fuso Yakuhin Kogyo Co., Ltd., priming capacity: about 1.45L / 7 minutes, liquid temperature: 35-37 ° C

<Test conditions>
Three artificial dialysis machines A1 to A3 are set as test tables, and in the next test condition of each test table, a vertical line portion 2a that is upstream of the tube 2 of the drainage line L5 shown in FIG. About the horizontal line part 2b which is, the adhesion condition of calcium carbonate was investigated.
○ Test stand A1 ・ ・ ・ After removing calcium carbonate adhering at the stage before the test with acid solution, 3 tablets of drainage treatment tablet T1 manufactured above in drainage funnel 1 (capacity about 200 ml) The test was carried out in such a manner that the tablet T1 in the drainage funnel 1 was supplemented to 3 tablets every Monday and Thursday every check.
○ Test stand A2: Without removing calcium carbonate adhering to the stage before the test, the drainage funnel 1 was loaded with 3 tablets of the above-mentioned drainage-treated tablets T1, and every Monday and Thursday Each time the check was performed, the test was performed in such a manner that the tablet T1 in the drainage funnel 1 was supplemented so that there were 3 tablets.
○ Test stand A3: After removing calcium carbonate adhering to the stage before the test with an acid solution, priming was performed in the same manner as before without using a drained tablet.

[Priming machine test 2]
Regarding the drainage line of the priming using the dialysate of the artificial dialysis apparatus (trade name GC-110N manufactured by JMS Co., Ltd.) that is in operation and requested to the medical institution B performing artificial dialysis treatment, the drainage treatment of the present invention When the calcium carbonate adhesion / removal test was performed depending on whether the tablet was used or not, the results shown in Table 3 below were obtained. The operating conditions for dialysis and priming and the test conditions are as follows.

<Operating conditions for dialysis and priming>
Dialysis operation cools: 2 cools on Monday, Wednesday and Friday, 1 cool on Tuesdays, Thursdays and Saturdays Priming fluid: Dialysate: Brand name made by Ajinomoto Chemicals, Priming capacity: 4L / 4min Liquid temperature: 35-37 ° C

<Test conditions>
Three dialysis machines B1 to B3 are set as test tables, and the front side of the horizontal line portion 2a, which is the downstream side of the tube 2 of the drainage line L5 shown in FIG. And the adhesion state of calcium carbonate was investigated about the rear side.
○ Test stand B1 ・ ・ ・ After removing the calcium carbonate adhering to the stage before the test with acid solution, load 3 tablets of the above-mentioned drainage treatment tablet T1 into the drainage funnel 1 (capacity 200ml). The test was carried out in such a manner that the tablet T1 in the drainage funnel 1 was supplemented to 3 tablets every Monday and Thursday.
○ Test stand B2: Without removing the calcium carbonate adhering to the stage before the test, the drainage funnel 1 was loaded with 3 tablets of the drainage treatment tablet T1, and every Monday and Thursday. Each time the check was performed, the test was performed in such a manner that the tablet T1 in the drainage funnel 1 was supplemented so that there were 3 tablets.
○ Test stand B3: Calcium carbonate adhering to the stage before the test was removed with an acid solution, and priming was performed in the same manner as before without using a drained tablet.

  From the results of Tables 1 and 2, by loading the drainage treatment tablet of the present invention into the drainage funnel 1 of the drainage line L5, adhesion of calcium carbonate in the tube 2 of the drainage line L5. It is clear that this can be reliably prevented. In addition, even if calcium carbonate has already adhered to the entire inner circumference of the tube 2, it is adhered by repeating the subsequent priming after the drainage treatment tablet of the present invention is loaded in the drainage funnel 1 as it is. It can also be seen that the calcium carbonate that has been dissolved is gradually dissolved and removed, and after a certain period of time, it can be recovered to a state without adhesion. In addition, according to the size and composition of the drainage treatment tablet T3 used, the three tablets are loaded into the drainage funnel 1 so that the dialysate flows into contact with any drainage treatment tablet T3. It has been found that approximately 1 tablet is consumed at 3 to 6 courses per day, depending on the type of patient monitoring device.

DESCRIPTION OF SYMBOLS 1 Drainage funnel 2 Tube 2a Vertical line part 2b Horizontal line part 3 Check valve 4 Drain pipe C1 Arterial chamber C2 Venous chamber D Dialyzer L Blood loop L1 Arterial blood circuit L2 Venous blood circuit L3 Dialysate line L4 Drain line L5 Drainage line P Blood pump T Drainage treatment tablet

Claims (4)

In priming with the dialysate of the arteriovenous blood circuit including the dialyzer of the artificial dialyzer, the dialysate is supplied to the blood circuit loop connecting the ends of the arterial blood circuit and the venous blood circuit, and reverse filtration is performed with the dialyzer. The dialyzed fluid that has been reverse-filtered is circulated to the blood circuit loop by a blood pump, and is provided on the inlet side of the drainage line at the discharge portion of the air and excess dialysate discharged from the blood circuit loop to the outside of the loop. The drainage funnel is placed, and the drainage funnel is loaded with a priming drainage treatment tablet formed by compression molding of acid powder, and the dialysate flowing into the drainage funnel from the drainage part is discharged into the drainage funnel. A priming method for an artificial dialysis machine, wherein the priming method is performed by contacting a treated tablet and discharging it to a drainage channel outside the system through the drainage line. The volume of the draining tablet for priming is 1-50 cm ^Three The priming method for an artificial dialysis apparatus according to claim 1, wherein 2 to 5 tablets are loaded into the drainage funnel. The drainage line is made of a flexible tube, and a check valve is interposed at the end thereof. The upstream side forms a vertical line portion depending from the drainage funnel, and the downstream side forms a horizontal line portion along the floor surface. The method for priming an artificial dialysis device according to claim 1 or 2, wherein the priming method is arranged as described above. The draining tablet for priming is composed of an acid powder mainly composed of at least one selected from maleic acid, malonic acid, succinic acid, and sulfamic acid, a disinfectant, and anhydrous sodium sulfate as an excipient. The method for priming an artificial dialysis device according to any one of claims 1 to 3, wherein the priming method is composed of a blended material.

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