JP2017070605A - Visualization test device and visualization test method of flow of blood purifier and holder used in the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To enable a flow state of blood in an inner space of a header of a blood purifier to be verified in a simulative manner.SOLUTION: A visualization test device 10 includes: a holder 11 holding a case 51 of a blood purifier 50 with a header of the blood purifier 50 detached; and a fluid circuit 12 arranged so as to enable a test fluid to be circulated via the holder 11. The holder 11 includes a header model 17 attached to the case 51 in place of the header. The header model 17 includes: an attachment part 21 attached to the case 51; and a fluid passing part 22 communicating with the attachment part 21 and arranged so as to enable the test fluid to be circulated with respect to the fluid circuit 12. The attachment part 21 includes a simulation space D formed into a shape simulating an inner space of the header when attached to the case 51 and is formed by a light transmissivity material visualizing a state of flow from outside when the test fluid circulated in the fluid circuit 12 passes through the simulation space D.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a flow visualization test apparatus and a visualization test method for a blood purifier, and a holding body used for the same, and more particularly, blood purification that removes wastes and the like in blood during blood filtration and dialysis. The present invention relates to a visualization test apparatus and a visualization test method for a flow of a blood purifier used for verifying a blood flow state in an internal space of a header of the container, and a holder used for these.

  There is a blood purifier for removing waste and the like in blood during blood filtration and dialysis. This blood purifier is composed of a cylindrical case, a large number of hollow fiber membranes housed in a bundle inside the case, and headers attached to both ends of the case. In the process of blood flowing into the internal space of the blood passing through the hollow fiber membrane and flowing out from the internal space of the other header, the waste in the blood is separated by the hollow fiber membrane and discharged to the outside. Purifies blood.

  By the way, for severe patients such as acute renal failure whose renal function is rapidly reduced, continuous renal function replacement that purifies blood over a long period of time in order to artificially remove wastes in the blood. Therapy is applied. In this therapy, a continuous loose blood filter (hereinafter simply referred to as “blood filter”) is used as the blood purifier. This blood filter is used for a longer period than a blood purifier (hemodialyzer) used for dialysis applied to patients with chronic renal failure and the like. Accordingly, the blood filter is required to maintain antithrombogenic properties for a long period of time, which suppresses the formation of thrombus over time in the blood flow path inside the blood filter. However, for example, if a stagnation region of a flow occurs in the blood filter, a blood clot is likely to occur in that region, and the antithrombotic property is influenced by the blood flow state in the blood filter. Analyzing and verifying the flow state is important for the design of hemofilters. At present, animal experiments are conducted as an antithrombogenicity test for hemofilters. However, in the animal experiments, it is impossible to accurately perform comparative evaluation of antithrombogenicity due to individual differences and the like. Et al. Have conducted intensive research on test devices and test methods for verifying the blood flow state in a blood filter that affects antithrombogenicity.

  By the way, Patent Document 1 discloses a blood purifier leak test apparatus. This leak testing device allows water to pass through a hollow fiber membrane present in the blood purifier, and detects the presence or absence of water leakage passing through the blood purifier by a change in pressure value due to damage to the hollow fiber membrane. Is.

JP-A-10-15059

  However, the leak test apparatus disclosed in Patent Document 1 detects the presence or absence of water leakage that passes through the blood purifier under a pressure that is significantly different from the actual usage environment. The flow state of blood passing through can not be grasped. Therefore, from this point of view, even if the test apparatus is used, it cannot be said that it can contribute effectively to the development of a blood purifier having excellent antithrombotic properties. As described above, in the blood purifier, the blood flowing into the internal space of one header passes through the hollow fiber membrane and is purified, and then flows out from the internal space of the other header to the outside. From this, the blood flow path in the blood purifier also includes the internal space of each header on the blood inlet side and blood outlet side in addition to the hollow fiber membrane. In consideration of thrombosis, it is necessary to analyze the flow state of the internal space.

  The present invention has been devised by paying attention to such a problem, and its purpose is blood purification useful for simulating the blood flow state in the internal space of the header of the blood purifier. An object of the present invention is to provide a visualization test apparatus and a visualization test method for a vessel flow, and a holder used for these.

  The present invention mainly includes a cylindrical case in which a hollow fiber membrane is accommodated inside, and headers attached to both ends in the longitudinal direction of the case, and blood flowing from one side of the header A predetermined test fluid is passed through a blood purifier that purifies blood in the process of passing through the hollow fiber membrane through the space and flowing out through the internal space on the other side of the header. An apparatus for simulating a blood flow visualization test in the internal space of the header, the holding body holding the case with the header removed, and the test fluid via the holding body A fluid circuit provided to circulate, and the holding body includes a header model attached to the case instead of the header, and the header model is attached to the case An attachment portion and a fluid passage portion that communicates with the attachment portion and is provided to allow the flow of the test fluid to the fluid circuit, and when the attachment portion is attached to the case, the header A translucent material in which a simulated space having a shape simulating the internal space is formed and the flow state when the test fluid circulating in the fluid circuit passes through the simulated space can be visually recognized from the outside It is formed by.

  The present invention is also a method for simulating a blood flow visualization test in the internal space of the header using the holding body, wherein the header is removed from the blood purifier and then attached to the case. The test liquid is supplied from the fluid passage portion of one of the header models in a state where the header model is fixed by the fixing means and the simulated space is formed, and the hollow fiber membrane The flow of the test liquid in the simulated space is observed from the outside of the header model and / or imaged with a camera in the process of discharging the test liquid from the fluid passage portion of the other header model through , Is adopted.

  According to the present invention, a simulated space is formed in the header model in the internal space of the header of the blood purifier, and the simulated space is visible from the outside of the header model. For this reason, the flow state of the test fluid in the simulation space can be visually recognized from the outside of the header model by flowing the test fluid in the simulation space. As a result, a tracer such as fluorescent particles is added to the test fluid, and the flow state such as the flow velocity distribution of the test fluid in the simulated space is captured over time by imaging the simulated space from the outside of the header model using a camera. Analysis becomes possible. This analysis makes it possible to verify the flow state of the blood flowing through the internal space for the header having the same shape as the simulated space, and the durability of the anti-thrombogenicity due to the relatively simple configuration of the experimental device. From the viewpoint, it is possible to determine the suitability of the internal shape design in the header.

The conceptual diagram showing the structure of the visualization test apparatus which concerns on this embodiment. The partial cross section front view of a blood purifier. The partial cross section front view of a holding body.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings.

  The conceptual diagram showing the structure of the visualization test apparatus of the flow of the blood purifier concerning this embodiment is shown by FIG. In this figure, the visualization test apparatus 10 uses a predetermined test fluid for the blood purifier 50 that separates waste and the like from blood during the filtration and dialysis of blood. This is a device for simulating a blood flow visualization test.

  Predetermined tracer particles are blended in the test fluid and adjusted to a viscosity comparable to that of blood. In the present embodiment, fluorescent particles that fluoresce when irradiated with light are used as tracer particles, and a glycerin aqueous solution containing the fluorescent particles is used as a test fluid. In the present invention, as long as a visualization test described later can be performed, other liquids having a fluid property similar to blood, blood, or the like can be used as the test fluid.

  In the present embodiment, the blood purifier 50 is a mode in which a visualization test is performed on a blood filter that filters blood during treatment by a continuous slow blood filtration method. Such other blood purifiers can also be applied as test objects according to the present invention.

  FIG. 2 shows a partial cross-sectional front view of blood purifier 50 in which only the upper end side portion in the drawing is shown in cross section. This blood purifier 50 includes a cylindrical case 51 that opens at both ends in the extending direction, which is the vertical direction in the figure, a header 52 that is attached to both ends of the case 51 so as to close the open portion, and a case. The thing of the well-known structure comprised by many hollow fiber membranes 53 bundled and accommodated in the inside of 51 is used.

  The upper header 52 in FIG. 2 is an inflow side of blood removed from the patient, and includes an inlet-side blood port 55 that guides the blood to the internal space S thereof. On the other hand, the lower header 52 in the figure is a blood outflow side to the outside, and is provided with a blood port 55 on the outlet side through which blood flows out from the internal space S. That is, blood from the inlet side blood port 55 enters the hollow fiber membrane 53 through the internal space S of the upper header 52 in the figure, and the purified blood in the process of passing through the hollow fiber membrane 53 It flows out of the blood purifier 50 from the blood port 55 on the outlet side through the inner space S of the lower header 52 in the figure. Further, the filtrate such as waste products separated by the hollow fiber membrane 53 is discharged from the dialysate port 57 provided on the peripheral surface of the case 51 to the outside of the blood purifier 50.

  As shown in FIG. 1, the visualization test apparatus 10 includes a holding body 11 that holds only a case 51 in a state where a header 52 (see FIG. 2) is removed from the blood purifier 50, and the holding body 11 through the holding body 11. The fluid circuit 12 is provided so that the test fluid can be circulated, the light irradiation means 14 is provided in the vicinity of the holding body 11, and the imaging means 15 is provided in the vicinity of the holding body 11.

  FIG. 3 is a partial cross-sectional front view of the holding body 11 in which only the upper end side portion in the drawing is shown in cross section. The holding body 11 is composed of a header model 17 disposed in a pair on both the upper and lower sides in the figure so as to sandwich both end sides of the case 51 and a fixing means 19 for fixing the header model 17.

  Each header model 17 is formed of a light-transmitting material such as silicone, and is not particularly limited, but is provided in a prismatic outer shape. The header model 17 is connected to the mounting portion 21 attached to the end portion of the case 51 from which the header 52 (see FIG. 2) is removed, and the test fluid for the fluid circuit 12 (see FIG. 1). And a fluid passage portion 22 provided so as to be able to circulate.

  The mounting portion 21 is formed by partially denting one end surface of the header model 17, and is provided in an internal shape that is substantially the same as the internal space S (see FIG. 2) of the header 52. The case 51 can be mounted in a state almost the same as the mounting state of the header 52. That is, the mounting portion 21 is attached to both end sides of the case 51 instead of the header 52 during the visualization test by the visualization test apparatus 10, and the inside of the header 52 is mounted in the case 51. A simulated space D having a shape simulating the space S is formed.

  The fluid passage portion 22 is configured as a flow path extending in the vertical direction in FIG. 3 so as to penetrate the end surface of the header model 17 opposite to the mounting portion 21 side and the internal space of the mounting portion 21.

  In a state where the header model 17 is mounted on the case 51, the header model 17 is formed of a light-transmitting material and its internal structure can be visually recognized. Therefore, the simulated space D surrounded by the inner wall of the mounting portion 21 and the fluid passage portion The state of the flow of the test fluid passing through 22 can be viewed from the outside.

  The header model 17 includes the mounting portion 21 that can form the simulated space D, and is not limited to the prismatic outer shape of the embodiment as long as the simulated space D is visible from the outside. Various outer shapes such as a columnar shape and an outer shape corresponding to the header 52 can be selected.

  The fixing means 19 includes a pair of acrylic plates 24 and 24 sandwiching the upper and lower sides of each header model 17 in FIG. 3 in a state where the header model 17 is attached to both ends of the case 51, and the header model 17 and the case 51. The outer space is used, and the four corners of the acrylic plates 24, 24 are connected to each other, and the shaft 25 is fixed with screws (not shown). As the fixing means 19, various structures can be adopted as long as the state in which the header models 17 are mounted on the upper and lower sides of the case 51 in the figure can be maintained.

  The holding body 11 holding the case 51 is set in the middle of the fluid circuit 12 as shown in FIG. In this state, the test fluid from the fluid circuit 12 is guided to the simulated space D from the fluid passage portion 22 with the one header model 17 on the upper side in FIG. Thereafter, the test fluid passes through the hollow fiber membrane 53 in the case 51, passes through the simulated space D from the other header model 17 on the lower side in FIG. It has come to be leaked.

  The fluid circuit 12 includes a liquid tank 27 in which a test fluid is stored, an inflow-side main flow path 28 connected between the fluid passage portion 22 and the liquid tank 27 of the upper header model 17 in FIG. An outflow side main flow path 29 connected between the fluid passage portion 22 of the middle and lower header model 17 and the liquid tank 27; a sub flow path 30 connected between the dialysate port 57 of the case 51 and the liquid tank 27; A first pump 32 provided at a position higher than the liquid tank 27 in the middle of the inflow-side main flow path 28, and supplying a test fluid in the liquid tank 27 to the inflow-side header model 17, and a sub-flow path 30 and a second pump 33 that is disposed at substantially the same height as the first pump 32 and returns the test fluid from the dialysate port 57 to the liquid tank 27. In FIG. 1, the lower side in the figure is the installation surface G, and each component is arranged so as to be higher in the upper direction in the figure. Accordingly, the holding body 11 in a state where the case 51 is held is disposed at a height position between the first and second pumps 32 and 33 and the liquid tank 27 installed on the installation surface G. .

  The liquid tank 27 is provided with a thermostat 35 such as a heater for maintaining and controlling the temperature of the test fluid at a temperature corresponding to the body temperature of the human body (about 37 ° C.).

  Further, the test fluid that has flowed out from the fluid passage portion 22 of the lower header model 17 on the lower side in FIG. 1 is returned to the liquid tank 27 through the outflow side main flow path 29 also using gravity. It has become. In the middle of the outflow side main flow path 29, flow path resistance applying means 37 for adjusting the pressure and flow rate of the test fluid flowing through the main flow paths 28 and 29 is provided.

  The first and second pumps 32 and 33 are constituted by roller pumps, and the pressure and flow rate of the test liquid flowing through the inflow side main flow path 28 and the sub flow path 30 are desired based on measured values of a sensor (not shown). Adjustable to the state of For example, for the test fluid that simulates the filtration environment of the blood purifier 50 during the treatment of the continuous slow blood filtration method and flows through the inflow-side main flow path 28, a flow rate that corresponds to the average blood flow rate during the treatment (for example, 100 ml / min) and a pressure corresponding to the inlet pressure of the filter during the treatment (for example, 70 mmHg). The flow rate of the test fluid in the sub-channel 30 is set to a flow rate (for example, 10 ml / min) corresponding to the average filtration flow rate of the filtrate during the treatment.

  The light irradiation means 14 is provided so that the fluorescent particles contained in the test fluid passing through the header model 17 can be irradiated with light from the outside of the header model 17. In the present embodiment, although not particularly limited, a laser sheet light source is used as the light irradiation means 14.

  The imaging means 15 is not particularly limited, but a high-speed camera is used, and is provided at a position where the simulated space D that can be visually recognized from the outside can be imaged from the outside of the header model 17. . In this imaging means 15, the temporal operation state in the simulated space D of the fluorescent particles that are fluorescent with the light from the light irradiation means 14 is imaged. As a result, it is possible to analyze and verify the change over time in the flow state such as the flow velocity of each part of the test fluid in the simulated space D.

  Next, a visualization test method for the flow of the blood purifier 50 using the visualization test apparatus 10 will be described.

  First, the blood purifier 50 to be tested is removed from the case 51 by cutting all of the headers 52 fixed to both ends of the case 51 or the end near the blood port 55. At the same time, the header model 17 having the internal shape of the mounting portion 21 corresponding to the shape of the internal space of the header 52 is prepared. Then, the header model 17 is attached to both ends of the case 51 and fixed by the fixing means 19, and the holding body 11 holding the case 51 is set in the fluid circuit 12. Then, each of the first and second pumps 32 and 33 is driven to circulate the test fluid in the fluid circuit 12, and the light irradiation means 14 passes through the header model 17 and the case 51 in the process of passing the test fluid. The movement of the fluorescent particles in the simulated space D in the header model 17 can be visually recognized from the outside by the fluorescence of the fluorescent particles by the irradiation of the light to the test fluid. Therefore, the movement of the fluorescent particles in the simulated space D can be known over time by observing visually from the outside of the header model 17 and capturing an image of the inside of the simulated space D with the imaging unit 15. Then, the flow of the test fluid in the simulated space D can be visualized from the movement of the fluorescent particles, and fluid analysis such as the flow velocity distribution in the test fluid in the simulated space D can be performed based on the visualization. As a result, the blood flow state in the internal space S of the header 52 can be estimated.

  In the above embodiment, the case where the visualization test is performed by replacing the headers 52 at both ends of the case 51 with the header model 17 is illustrated and described. However, the present invention is not limited to this, and any one of the headers 52 in the case 51 is illustrated. Only the header model 17 is replaced, and the holding body 11 is set in the fluid circuit 12 with the other header 52 left as it is and is attached to the case 51, and only the flow of the part exchanged with the header model 17 is simulated. Visualization tests can also be performed. In this case, the header 52 attached to the case 51 is connected to one of the main flow paths 28 and 29 to which the header model 17 is not connected.

  In addition, the configuration of each part of the apparatus in the present invention is not limited to the illustrated configuration example, and various modifications are possible as long as substantially the same operation is achieved.

DESCRIPTION OF SYMBOLS 10 Visualization test apparatus 11 Holding body 12 Fluid circuit 17 Header model 19 Fixing means 21 Mounting part 22 Fluid passage part 27 Fluid tank 28 Inflow side main flow path 29 Outflow side main flow path 30 Sub flow path 32 1st pump 33 2nd Pump 50 Blood purifier 51 Case 52 Header 53 Hollow fiber membrane 57 Dialysate port D Simulated space S Internal space

By the way, for severe patients such as acute renal failure whose kidney function rapidly decreases, continuous renal function replacement that purifies blood over a long period of time in order to artificially remove waste in the blood Therapy is applied. In this therapy, as the blood purifier, continuous blood filter (hereinafter, simply referred to as "blood filter") is used. This blood filter is used for a longer period than a blood purifier (hemodialyzer) used for dialysis applied to patients with chronic renal failure and the like. Accordingly, the blood filter is required to maintain antithrombogenic properties for a long period of time, which suppresses the formation of thrombus over time in the blood flow path inside the blood filter. However, for example, if a stagnation region of a flow occurs in the blood filter, a blood clot is likely to occur in that region, and the antithrombotic property is influenced by the blood flow state in the blood filter. Analyzing and verifying the flow state is important for the design of hemofilters. At present, animal experiments are conducted as an antithrombogenicity test for hemofilters. However, in the animal experiments, it is impossible to accurately perform comparative evaluation of antithrombogenicity due to individual differences and the like. Et al. Have conducted intensive research on test devices and test methods for verifying the blood flow state in a blood filter that affects antithrombogenicity.

Further, in the present embodiment, as a blood purifier 50, continuous blood has a mode for performing visualization test filtration method by blood during treatment targeting a hemofilter for filtering but, hemodialysis or the like used for dialysis Other blood purifiers can also be applied as test objects according to the present invention.

The upper header 52 in FIG. 2 is an inflow side of blood removed from the patient, and includes an inlet-side blood port 55 that guides the blood to the internal space S thereof. On the other hand, the lower header 52 in the figure is a blood outflow side to the outside, and is provided with a blood port 55 on the outlet side through which blood flows out from the internal space S. That is, blood from the inlet side blood port 55 enters the hollow fiber membrane 53 through the internal space S of the upper header 52 in the figure, and the purified blood in the process of passing through the hollow fiber membrane 53 It flows out of the blood purifier 50 from the blood port 55 on the outlet side through the inner space S of the lower header 52 in the figure. Further, the filtrate such separated wastes in the hollow fiber membrane 53, are discharged from the port 57 provided on the peripheral surface of the case 51 to the outside of the blood purifier 50.

The fluid circuit 12 includes a liquid tank 27 in which a test fluid is stored, an inflow-side main flow path 28 connected between the fluid passage portion 22 and the liquid tank 27 of the upper header model 17 in FIG. the outflow-side main flow path 29 connected between the fluid passage 22 and the liquid tank 27 of the middle below the header model 17, and the sub flow path 30 connected between the port 57 and the liquid tank 27 of the case 51 A first pump 32 provided at a position higher than the liquid tank 27 in the middle of the inflow-side main flow path 28, and supplying a test fluid in the liquid tank 27 to the inflow-side header model 17, and a sub-flow path while it is disposed substantially flush with the first pump 32 in the course of 30, and a second pump 33 for returning a test fluid from the port 57 to the liquid tank 27. In FIG. 1, the lower side in the figure is the installation surface G, and each component is arranged so as to be higher in the upper direction in the figure. Accordingly, the holding body 11 in a state where the case 51 is held is disposed at a height position between the first and second pumps 32 and 33 and the liquid tank 27 installed on the installation surface G. .

The first and second pumps 32 and 33 are constituted by roller pumps, and the pressure and flow rate of the test liquid flowing through the inflow side main flow path 28 and the sub flow path 30 are desired based on measured values of a sensor (not shown). Adjustable to the state of For example, to simulate the filtering environment of the blood purifier 50 during the continuous blood filtration treatment, the test fluid flowing through the inflow-side main flow path 28, the flow rate (e.g., corresponding to the average blood flow rate during the treatment, 100 ml / Min) and a pressure corresponding to the inlet pressure of the filter during the treatment (for example, 70 mmHg). The flow rate of the test fluid in the sub-channel 30 is set to a flow rate (for example, 10 ml / min) corresponding to the average filtration flow rate of the filtrate during the treatment.

DESCRIPTION OF SYMBOLS 10 Visualization test apparatus 11 Holding body 12 Fluid circuit 17 Header model 19 Fixing means 21 Mounting part 22 Fluid passage part 27 Fluid tank 28 Inflow side main flow path 29 Outflow side main flow path 30 Sub flow path 32 1st pump 33 2nd pump 50 blood purifier 51 case 52 header 53 hollow fiber membrane 57 port <br/> D simulated space S interior space of

Claims (5)

A cylindrical case in which a hollow fiber membrane is housed, and headers attached to both ends in the longitudinal direction of the case, and blood that has flowed in from one side of the header passes through the internal space to form the hollow A predetermined test fluid is allowed to flow through a blood purifier that purifies blood in the process of passing through the thread membrane and flowing out through the inner space on the other side of the header. A device for simulating a blood flow visualization test in
A holding body that holds the case with the header removed, and a fluid circuit that is provided so that the test fluid can be circulated through the holding body,
The holding body includes a header model attached to the case instead of the header,
The header model includes a mounting portion that is mounted on the case, and a fluid passage portion that communicates with the mounting portion and is provided to allow the flow of the test fluid to the fluid circuit.
When the mounting portion is mounted on the case, a simulated space having a shape simulating the internal space of the header is formed, and the test fluid circulating in the fluid circuit passes through the simulated space. An apparatus for visualizing the flow of a blood purifier, characterized in that it is made of a light-transmitting material that can be visually recognized from the outside.   The fluid circuit includes a liquid tank in which the test fluid is stored, and an inflow side main flow path connected between the liquid tank and the fluid passage portion of the header model serving as the inflow side of the test fluid; An outflow side main flow channel connected between the liquid tank and the fluid passage part of the header model which is an outflow side of the test fluid, and provided in the liquid tank and the case and separated by the hollow membrane body A sub-flow path connected to a dialysate port for discharging the liquid and a first flow path that is provided in the inflow side main flow path and supplies the test fluid in the liquid tank to the fluid circulation portion. 2. The blood purifier according to claim 1, further comprising: a second pump that is provided in the sub-flow path and returns the test fluid from the dialysate port to the liquid tank. Flow visualization test device.   The blood purifier according to claim 2, wherein the holding body is arranged at a position higher than the liquid tank, and the first and second pumps are arranged at a position higher than the holding body. Flow visualization test equipment. A cylindrical case in which a hollow fiber membrane is housed, and headers attached to both ends in the longitudinal direction of the case, and blood that has flowed in from one side of the header passes through the internal space to form the hollow A predetermined test fluid is allowed to flow through a blood purifier that purifies blood in the process of passing through the fimbriae and flowing out through the inner space on the other side of the header. A holding body for holding the case when performing a blood flow visualization test in
A header model that is attached to the case instead of the header, and a fixing means that fixes the header model,
The header model includes a mounting portion that is mounted on the case, and a fluid passage portion that communicates with the mounting portion and is provided to allow the test fluid to flow.
When the mounting portion is mounted on the case, a simulated space having a shape simulating the internal space of the header is formed, and a flow state when the test fluid passes through the simulated space is formed. A holding body characterized by being formed of a translucent material that is visible from the outside. A method for simulating a blood flow visualization test in the internal space of the header using the holder according to claim 4,
After removing the header from the blood purifier, mounting the mounting portion on the case, and fixing the header model by the fixing means to form the simulated space, one of the header models In the process of supplying the test liquid from the fluid passage portion and discharging the test liquid from the fluid passage portion of the other header model through the hollow fiber membrane, the test liquid in the simulated space is discharged. A blood visualization test method for blood purifier flow, wherein the flow is observed from outside the header model and / or imaged with a camera.

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