CN114061853B - Blood pump sealing test method - Google Patents
Blood pump sealing test method Download PDFInfo
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- CN114061853B CN114061853B CN202111215509.4A CN202111215509A CN114061853B CN 114061853 B CN114061853 B CN 114061853B CN 202111215509 A CN202111215509 A CN 202111215509A CN 114061853 B CN114061853 B CN 114061853B
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- 210000004369 blood Anatomy 0.000 title claims abstract description 95
- 239000008280 blood Substances 0.000 title claims abstract description 95
- 238000007789 sealing Methods 0.000 title claims abstract description 49
- 238000010998 test method Methods 0.000 title claims abstract description 20
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 59
- 239000007788 liquid Substances 0.000 claims abstract description 44
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 42
- 229910001415 sodium ion Inorganic materials 0.000 claims abstract description 39
- 238000012360 testing method Methods 0.000 claims abstract description 23
- 239000011780 sodium chloride Substances 0.000 claims abstract description 20
- 238000012886 linear function Methods 0.000 claims abstract description 4
- 238000004140 cleaning Methods 0.000 claims description 12
- 238000007599 discharging Methods 0.000 claims description 2
- 239000000243 solution Substances 0.000 description 26
- 238000000034 method Methods 0.000 description 10
- 238000012546 transfer Methods 0.000 description 7
- 210000002381 plasma Anatomy 0.000 description 6
- 239000012530 fluid Substances 0.000 description 4
- 230000003204 osmotic effect Effects 0.000 description 4
- 239000002504 physiological saline solution Substances 0.000 description 4
- 230000000740 bleeding effect Effects 0.000 description 3
- 238000012552 review Methods 0.000 description 3
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 2
- 238000012942 design verification Methods 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 239000011734 sodium Substances 0.000 description 2
- 229910052708 sodium Inorganic materials 0.000 description 2
- 210000000601 blood cell Anatomy 0.000 description 1
- 210000001772 blood platelet Anatomy 0.000 description 1
- 230000036772 blood pressure Effects 0.000 description 1
- 210000005013 brain tissue Anatomy 0.000 description 1
- 238000004364 calculation method Methods 0.000 description 1
- 125000004122 cyclic group Chemical group 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 210000003743 erythrocyte Anatomy 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 210000000265 leukocyte Anatomy 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 230000010412 perfusion Effects 0.000 description 1
- 238000005086 pumping Methods 0.000 description 1
- 239000000523 sample Substances 0.000 description 1
- 230000002861 ventricular Effects 0.000 description 1
Classifications
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01M—TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
- G01M3/00—Investigating fluid-tightness of structures
- G01M3/02—Investigating fluid-tightness of structures by using fluid or vacuum
- G01M3/26—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/02—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance
- G01N27/04—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance by investigating resistance
- G01N27/06—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance by investigating resistance of a liquid
Landscapes
- Physics & Mathematics (AREA)
- General Physics & Mathematics (AREA)
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Electrochemistry (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The invention belongs to the technical field of blood pump tests, and particularly discloses a blood pump sealing test method, which comprises the following steps: s1, one end of a blood chamber system is connected with a liquid storage device I, one end of a pure water sealing system is connected with a liquid storage device II, and the blood chamber system is cleaned in a circulating way; s2, injecting sodium chloride solution into the liquid storage device I, measuring a conductivity value G1, injecting pure water into the liquid storage device II, and measuring a conductivity value G2; s3, starting a blood pump to circulate; s4, after t hours, measuring the conductivity value G3 of the liquid in the pure water sealing system; s5, na ion concentration c1= (G2-a)/b in the pure water sealing system at the beginning, na ion concentration c2= (G3-a)/b in the pure water sealing system at the end, na ion concentration c3= (G1-a)/b in the blood chamber system, leakage amount= (c 2-c 1) multiplied by V2/c 3; wherein: v2 is the pure water volume; na ion concentration; a and b are coefficients of the test instrument characterizing a linear function of conductivity and Na ion concentration. The test method is simple to operate, low in interference degree, high in precision, low in error and reliable in data.
Description
Technical Field
The invention belongs to the technical field of blood pump tests, and particularly relates to a blood pump sealing test method.
Background
The blood pump, i.e. the artificial heart blood pump, is a variable speed, variable volume, miniature pump that is used to replace the heart entirely. The artificial heart is used as an auxiliary and alternative device for heart blood pumping function, in particular an implantable ventricular auxiliary pump, needs to assist circulation in vivo for a long time, maintains normal blood pressure of the body and effective perfusion of brain tissues and other important organs, and has extremely high requirements on effectiveness, sealing performance, safety and stability.
The mechanical seal part of the blood pump has very small gaps below 1 μm, so that the blood chamber cannot leak blood cell components (red blood cells 6-8 μm, white blood cells 10-25 μm and blood platelets 2-3 μm) into the pure water seal liquid chamber, but partial plasma components possibly leak, and a large amount of plasma leaks to the pure water seal liquid side, so that the filter forming a component of the pure water seal is possibly blocked, and potential safety hazards exist.
Disclosure of Invention
The invention aims to provide a blood pump sealing test method, which is characterized in that physiological saline is used for replacing blood to carry out sealing test, the Na ion content in each solution is calculated through conductivity, the Na ion transfer amount is calculated according to the Na ion initial and final contents of each solution, and finally the Na ion transfer amount is used for quantifying the leakage amount of blood pump liquid, so that the sealing performance of the blood pump can be known.
In order to achieve the above purpose, the technical scheme of the invention is as follows:
The blood pump sealing test method comprises the following steps:
S1, connecting a liquid storage device I at one end of a blood chamber system of a blood pump, connecting a liquid storage device II at one end of a pure water sealing system of the blood pump, then injecting pure water into the blood chamber system and the pure water sealing system, and discharging the blood pump after circulating cleaning;
s2, injecting a V1 amount of sodium chloride solution into the liquid storage device I, measuring a conductivity value G1, injecting a V2 amount of pure water into the liquid storage device II, and measuring a conductivity value G2;
s3, transversely placing the blood pump, starting the blood pump, and circulating;
s4, after t hours, measuring the conductivity value G3 of the liquid in the pure water sealing system again;
S5, calculating leakage amount from the conductivity according to the following mode:
The Na ion concentration c1= (G2-a)/b of the liquid in the pure water sealing system at the beginning,
At the end, the Na ion concentration c2= (G3-a)/b of the liquid in the pure water sealing system,
Na ion concentration c3= (G1-a)/b of sodium chloride solution in blood chamber system,
Leakage amount= (c 2-c 1) ×v2++c3;
Wherein: v2 is the pure water volume of the pure water sealing side, and the unit is mL; na ion concentration in mg/L; conductivity unit is ms/m; a and b are coefficients of the test instrument characterizing a linear function of conductivity and Na ion concentration.
Preferably, in step S2, the concentration of the sodium chloride solution injected into the reservoir i is 0.9%, the sodium chloride solution at this concentration is physiological saline, the osmotic pressure, sodium content, and the like are substantially equal to those of human blood plasma, and the osmotic pressure in the environment of the blood is simulated, thereby improving the test accuracy.
Preferably, in step S3, the blood pump speed is 2150-2250rpm. In the practical use process, the higher the rotating speed of the blood pump is, the more leakage amount of the mechanical seal is, the rotating speed of the blood pump is 1600-2200 rpm, the maximum rotating speed of the blood pump is 2200rpm, and the rotating speed of the blood pump is set to be a value close to the maximum rotating speed in the test method, so that the maximum leakage environment is ensured.
Preferably, in step S1, the single cleaning cycle time of the blood pump is 5-6min, and the cleaning times are 3-4 times, so that the blood pump is ensured to be cleaned.
Preferably, the volume of the sodium chloride solution in the reservoir I is 450-550mL, and the volume of the pure water in the reservoir II is 380-420mL, so that the loads of the blood chamber system and the pure water sealing system are basically consistent with the loads in the actual use process.
Preferably, in step S3, the flow rate of the pure water sealing system is set to 115-125mL/min.
Preferably, in step S4, t is 12 or 24, and the single test time is typically 24 hours, i.e. one day, for easy counting.
In the scheme, physiological saline is used for replacing blood for sealing test, the Na ion content in each solution is calculated through conductivity, the Na ion transfer amount is calculated according to the Na ion initial and final contents of each solution, and finally the Na ion transfer amount is used for quantifying the leakage amount of the blood pump liquid, so that the sealing performance of the blood pump can be known.
In the practical use process of the blood pump, if the leakage amount is about 1.0 mL/day, the filter is likely to be blocked in 1 month, and if the leakage amount is less than 0.5 mL/day, the test method is qualified, if the leakage amount is 0.5 mL/day, the filter is blocked, 60 days are required, and the safety rate is about 2 times compared with the hospital-arrival review frequency of the patient (one time from every 30 days to the hospital). The higher the viscosity of the fluid, the less leakage will occur in the mechanical seal, and when the product is actually used, the fluid in the blood chamber system is blood with higher viscosity, while the viscosity of the solution used in the above-mentioned design verification test is almost equal to that of pure water, and the leakage is easier to occur with respect to blood, so that the leakage amount of the plasma component is considered to be smaller in actual use than in the test of the present method.
The test method is simple to operate, low in interference degree, high in precision, low in error and reliable in data.
Drawings
FIG. 1 is a schematic diagram of an embodiment of the present invention;
FIG. 2 is a graph of conductivity as a function of Na ion concentration in the conductivity instrument of the example.
Reference numerals in the drawings of the specification include: a blood chamber system 1, a pure water sealing system 2, a liquid storage device I3 and a liquid storage device II 4.
Detailed Description
The drawings in the present specification are schematic views, which assist in explaining the concept of the present invention, and schematically show the shapes of the respective parts and their interrelationships.
Hereinafter, a preferred embodiment according to the present invention will be described in detail with reference to fig. 1.
The embodiment provides a blood pump sealing test method, which comprises the following steps:
step one, preparation before testing
S1, as shown in FIG. 1, a liquid reservoir I3 is connected to one end of a blood chamber system 1 of a blood pump, a liquid reservoir II 4 is connected to one end of a pure water sealing system 2 of the blood pump, pure water is injected into the blood chamber system 1 and the pure water sealing system 2, and the blood pump is discharged after being circularly cleaned.
The bleeding port and the blood inlet of the blood chamber system 1 are connected with the liquid storage device I3, so that the blood chamber system 1 and the liquid storage device I3 form a loop, and the pure water sealing system 2 and the liquid storage device II 4 form a loop to simulate the loop and the liquid circulation condition of the blood pump after implantation.
After the instrument connection is completed, the blood chamber system 1 and the pure water sealing system 2 are cleaned, specifically, pure water is respectively added into the liquid storage device I3 and the liquid storage device II 4, then a blood pump is started for circulation cleaning, and pure water is discharged after the cleaning is completed.
In the embodiment, the single cleaning cycle time of the blood pump is 5-6min, pure water is replaced after each cleaning, and the cleaning times are 3-4, so that the blood pump can be ensured to be completely cleaned in the cleaning process.
Step two, sealing test
S2, injecting a sodium chloride solution with the volume of V1 into the liquid storage I3, measuring the conductivity value G1 of the sodium chloride solution, injecting pure water with the volume of V2 into the liquid storage II 4, and measuring the conductivity value G2 of the pure water.
In this embodiment, the concentration of the sodium chloride solution is 0.9%, the sodium chloride solution under the concentration is normal saline, the osmotic pressure, sodium content and the like are basically equal to those of human blood plasma, the osmotic pressure in the environment of bleeding is simulated, and the test accuracy is improved.
And the volume of the sodium chloride solution in the liquid storage device I3 is 450-550mL, and the volume of the pure water in the liquid storage device II 4 is 380-420mL, so that the loads of the blood chamber system 1 and the pure water sealing system 2 are basically consistent with the load in the actual use process, the load environment after the implantation of the bleeding pump is simulated, and the test accuracy is improved.
The conductivity values of the sodium chloride solution and the pure water in this example were mainly measured by a conductivity meter.
S3, transversely placing the blood pump, starting the blood pump, and circulating.
The posture of the blood pump is adjusted to be consistent with the posture of the implanted human body, so that the test effect is enhanced. And controlling the rotating speed of the blood pump to 2150-2250rpm, wherein in the actual use process, the higher the rotating speed of the blood pump is, the more leakage amount of the mechanical seal is, the rotating speed of the blood pump is 1600-2200 rpm, and the maximum rotating speed of the blood pump is 2200 rpm.
In the embodiment, during the cyclic test, the flow rate of the pure water sealing system 2 is set to be 115-125mL/min, and is consistent with the flow rate during actual use.
In the circulation test process, the sodium chloride solution in the blood chamber system 1 leaks into the pure water sealing system 2 through the gap of the mechanical sealing part of the blood pump, so that the pure water in the pure water sealing system 2 contains Na ions, and the leakage amount of the sodium chloride solution is quantified through the transfer amount of the Na ions.
Step three, leakage amount calculation
S4, after t hours of circulation, measuring the conductivity value G3 of the liquid in the pure water sealing system 2 again.
Since the sodium chloride solution in the blood chamber system 1 partially leaks into the water seal system, the conductivity value G3 of the liquid in the pure water seal system 2 at this time is significantly changed from the conductivity value G2 at the beginning.
In this embodiment, t is 12 or 24, and the single test time is usually 24 hours, i.e. one day, so that the counting is convenient, and the number of review days of the patient is convenient to quantify.
S5, calculating leakage amount from the conductivity according to the following mode:
the Na ion concentration c1= (G2-a)/b of the liquid in the pure water sealing system 2 at the beginning,
At the end the Na ion concentration c2= (G3-a)/b of the liquid in the pure water sealing system 2,
Na ion concentration c3= (G1-a)/b of sodium chloride solution in blood chamber system 1,
Leakage amount= (c 2-c 1) ×v2++c3;
Wherein: v2 is the pure water volume of the pure water sealing system 2, and the unit is mL; na ion concentration in mg/L; conductivity unit is ms/m; a and b are coefficients of the test instrument characterizing a linear function of conductivity and Na ion concentration.
Referring to fig. 2, in this embodiment, the conductivity tester is a conductivity meter with model DKK-TOA, probe model CT-57101C, and host model MM-60R. In this example, the values of a and b were obtained by linear fitting the measured conductivity (ms/m) to the Na ion concentration (mg/L) to obtain a straight line with the conductivity g=b×na ion concentration+a.
| Solution number | Nacl concentration (mg/L) | Na ion concentration (mg/L) | Conductivity (ms/m) | Solution temperature (. Degree. C.) |
| 1 | 584.40 | 2299.00 | - | - |
| 2 | 5.84 | 22.99 | 13.95 | 27.4 |
| 3 | 1.17 | 4．60 | 3.200 | 26.4 |
| 4 | 0.58 | 2.30 | 1.671 | 26.4 |
| 5 | 0.29 | 1.15 | 0.860 | 27.1 |
| 6 | 0.00 | 0.00 | 0.061 | 28.1 |
From the above experimental parameters, a graph of conductivity (ms/m) as a function of Na ion concentration (mg/L) is obtained, see fig. 2, and b=0.5987, a= 0.2322 is obtained.
In the scheme, physiological saline is used for replacing blood for sealing test, the Na ion content in each solution is calculated through conductivity, the Na ion transfer amount is calculated according to the Na ion initial and final contents of each solution, and finally the Na ion transfer amount is used for quantifying the leakage amount of the blood pump liquid, so that the sealing performance of the blood pump can be known.
In the practical use process of the blood pump, if the leakage amount is about 1.0 mL/day, the filter is likely to be blocked in 1 month, and if the leakage amount is less than 0.5 mL/day, the test method is qualified, if the leakage amount is 0.5 mL/day, the filter is blocked, 60 days are required, and the safety rate is about 2 times compared with the hospital-arrival review frequency of the patient (one time from every 30 days to the hospital). The higher the viscosity of the fluid, the less leakage will occur in the mechanical seal, and when the present product is used in practice, the fluid in the blood chamber system 1 is blood having a higher viscosity, whereas the viscosity of the solution used in the above-described design verification test is almost equivalent to that of pure water, and is more likely to leak relative to blood, and therefore, the leakage amount of the plasma component is considered to be smaller in practical use than in the test of the present method.
The test method is simple to operate, low in interference degree, high in precision, low in error and reliable in data.
The foregoing describes in detail preferred embodiments of the present invention. It should be understood that numerous modifications and variations can be made in accordance with the concepts of the invention by one of ordinary skill in the art without undue burden. Therefore, all technical solutions which can be obtained by logic analysis, reasoning or limited experiments based on the prior art by the person skilled in the art according to the inventive concept shall be within the scope of protection defined by the claims.
Claims (7)
1. The blood pump sealing test method is characterized by comprising the following steps of:
S1, connecting a liquid reservoir I (3) at one end of a blood chamber system (1) of a blood pump, connecting a liquid reservoir II (4) at one end of a pure water sealing system (2) of the blood pump, then injecting pure water into the blood chamber system (1) and the pure water sealing system (2), and discharging the blood pump after circulating cleaning;
S2, injecting a sodium chloride solution with the quantity of V1 into the liquid storage device I (3), measuring a conductivity value G1, injecting pure water with the quantity of V2 into the liquid storage device II (4), and measuring the conductivity value G2;
s3, transversely placing the blood pump, starting the blood pump, and circulating;
S4, after t hours, measuring the conductivity value G3 of the liquid in the pure water sealing system (2) again;
S5, calculating leakage amount from the conductivity according to the following mode:
the Na ion concentration c1= (G2-a)/b of the liquid in the pure water sealing system (2) at the beginning,
At the end, the Na ion concentration c2= (G3-a)/b of the liquid in the pure water sealing system (2),
Na ion concentration c3= (G1-a)/b of sodium chloride solution in blood chamber system (1),
Leakage amount= (c 2-c 1) ×v2++c3;
Wherein: v2 is the pure water volume of the pure water sealing system (2), and the unit is mL; na ion concentration in mg/L; conductivity unit is ms/m; a and b are coefficients of the test instrument characterizing a linear function of conductivity and Na ion concentration.
2. The blood pump seal test method of claim 1, wherein: the concentration of the sodium chloride solution injected into the reservoir I (3) in step S2 was 0.9%.
3. The blood pump seal test method of claim 1, wherein: in step S3, the blood pump speed is 2150-2250rpm.
4. The blood pump seal test method of claim 1, wherein: in the step S1, the single cleaning cycle time of the blood pump is 5-6min, and the cleaning times are 3-4.
5. The blood pump seal test method of claim 1, wherein: in the step S2, the volume of the sodium chloride solution in the liquid reservoir I (3) is 450-550mL, and the volume of the pure water in the liquid reservoir II (4) is 380-420mL.
6. The blood pump seal test method of claim 1, wherein: in the step S3, the flow rate of the pure water sealing system (2) is set to be 115-125mL/min.
7. The blood pump seal test method of claim 1, wherein: in step S4, t is 12 or 24.
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| CN202111215509.4A CN114061853B (en) | 2021-10-19 | 2021-10-19 | Blood pump sealing test method |
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| CN202111215509.4A CN114061853B (en) | 2021-10-19 | 2021-10-19 | Blood pump sealing test method |
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| CN114061853B true CN114061853B (en) | 2024-04-26 |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4443333A (en) * | 1981-09-24 | 1984-04-17 | Mahurkar Sakharam D | Portable dialysis system and pump therefor |
| WO2000012991A1 (en) * | 1998-08-26 | 2000-03-09 | Aksys, Ltd. | Blood tubing set integrity tests for extracorporeal circuits |
| CN206103035U (en) * | 2016-06-28 | 2017-04-19 | 清华大学 | Blood pump testing system |
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2021
- 2021-10-19 CN CN202111215509.4A patent/CN114061853B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4443333A (en) * | 1981-09-24 | 1984-04-17 | Mahurkar Sakharam D | Portable dialysis system and pump therefor |
| WO2000012991A1 (en) * | 1998-08-26 | 2000-03-09 | Aksys, Ltd. | Blood tubing set integrity tests for extracorporeal circuits |
| CN206103035U (en) * | 2016-06-28 | 2017-04-19 | 清华大学 | Blood pump testing system |
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