CN108896426B - System and method for evaluating hemostatic performance of dressing in vitro - Google Patents
System and method for evaluating hemostatic performance of dressing in vitro Download PDFInfo
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Abstract
The invention discloses a dressing hemostasis performance in-vitro evaluation system and method, relates to the technical field of medical detection equipment, and aims to solve the technical problems that when the existing animal model is used for evaluating and detecting the dressing hemostasis performance, the result is inaccurate, quantification cannot be achieved, and the cost is high. In the in-vitro evaluation system for the hemostatic performance of the dressing, a test model mechanism for measuring the reduction rate of the blood flow flowing through the dressing is arranged on an analytical balance, the test model mechanism is communicated with a plurality of bubblers through a suction pipeline, and the front end of the suction pipeline is connected with a biological isolation air filter in series; the airflow dryer and the bubble counting device are integrated into a whole, and a drying agent is filled in a drying cavity of the airflow dryer; the operation touch device is connected with the airflow dryer and is used for executing constant negative pressure suction operation; and the data processing device is respectively connected with the analytical balance and the operation touch device, and is used for acquiring and processing data and outputting results.
Description
Technical Field
The invention relates to the technical field of medical detection equipment, in particular to a dressing hemostasis performance in-vitro evaluation system and method.
Background
Currently, in the prior art, evaluation and detection of hemostatic performance of dressings are generally performed by using animal models.
However, the inventor of the present application finds that, when the hemostatic performance of the dressing is evaluated and tested by using an animal model, the following defects are easy to exist:
the test animal and the human body have difference, and the evaluation detection result is inaccurate; the consumption of experimental animals is not beneficial to animal protection; the experimental design is relatively complex, the result cannot be quantized, and the hemostatic performance of the dressing is difficult to compare; the evaluation and detection cost is high.
Therefore, how to provide an in vitro evaluation system and method for the hemostatic performance of a dressing, which can realize the evaluation and detection of the hemostatic performance of the dressing in vitro, has become a technical problem that needs to be solved by those skilled in the art.
Disclosure of Invention
The invention aims to provide an in-vitro evaluation system and method for the hemostatic performance of a dressing, so as to solve the technical problems that the result is inaccurate, quantification cannot be realized and the cost is high when the hemostatic performance of the dressing is evaluated and detected by the conventional animal model.
The invention provides an in vitro evaluation system for the hemostatic performance of a dressing, which comprises: the device comprises an analytical balance, a plurality of bubble devices and a biological isolation air filter, wherein the analytical balance is provided with a test model mechanism for measuring the flow rate reduction rate of blood flowing through a dressing, the test model mechanism is communicated with the bubble devices through an attraction pipeline, and the front end of the attraction pipeline is connected in series with the biological isolation air filter; the air flow dryer is integrated with the bubble counting device, and a drying cavity of the air flow dryer is filled with a drying agent; the operation touch device is connected with the airflow dryer and is used for executing constant negative pressure suction operation; and the data processing device is respectively connected with the analysis antenna and the operation touch device, and is used for acquiring and processing data and outputting results.
In practical application, the test model mechanism comprises: a disposable sample holding device, the disposable sample holding device comprising: a blood container containing human whole blood, and a disposable syringe containing a test sample or a control sample; the disposable syringe is communicated with an injection needle, and the injection needle extends into the human whole blood in the blood container.
Wherein, test model mechanism still includes: the spring ball-touching clamping structure is used for clamping the disposable syringe.
Specifically, the spring knob chucking structure includes: the disposable syringe comprises a card body, a clamping head and a clamping head, wherein the card body is provided with an accommodating groove for clamping the disposable syringe, the card body is also provided with a groove which is perpendicular to and communicated with the accommodating groove, and a compression spring is arranged in the groove; one end of the compression spring is connected with the groove, the other end of the compression spring is connected with a steel ball, and the steel ball is in contact with the disposable injector.
Furthermore, the clamping body is provided with three groups of accommodating grooves and grooves at intervals, and each group of grooves is internally provided with a pair of compression springs and steel balls.
Still further, the test model mechanism further comprises: a fast lifting device located above the analytical balance; the quick lifting device comprises: a rack and a gear engaged with the rack; the spring ball-touching clamping structure is connected with the gear and can move up and down along the rack.
Still further, the quick lifting device further comprises: and the locking bolt is used for locking and fixing the spring ball-bumping clamping structure after the spring ball-bumping clamping structure is at a proper height.
Preferably, the bubble counter is a negative-pressure bubble counter, and the counting mode is photoelectric counting.
Compared with the prior art, the dressing hemostasis performance in-vitro evaluation system has the following advantages:
the in-vitro evaluation system for the hemostatic performance of the dressing provided by the invention comprises: an analytical balance, an air flow dryer, an operating touch device, and a data processing device; the analytical balance is provided with a test model mechanism for measuring the reduction rate of the blood flow flowing through the dressing, the test model mechanism is communicated with a plurality of bubble generators through a suction pipeline, and the front end of the suction pipeline is connected with a biological isolation air filter in series; specifically, the airflow dryer and the bubble counter are integrated into a whole, and a drying agent is filled in a drying cavity of the airflow dryer; further, the operation touch device is connected with the airflow dryer and is used for executing constant negative pressure suction operation; and the data processing device is respectively connected with the analytical balance and the operation touch device, and is used for acquiring and processing data and outputting results. Therefore, the in-vitro evaluation system for the hemostatic performance of the dressing, provided by the invention, can be used for evaluating and detecting the hemostatic performance of the dressing in vitro, so that various problems existing in the existing evaluation and detection by using an animal model are solved, and particularly, the evaluation and detection result is inaccurate due to the difference between a test animal and a human body; the consumption of experimental animals is not beneficial to animal protection; the experimental design is relatively complex, the result cannot be quantized, and the hemostatic performance of the dressing is difficult to compare; the evaluation and detection cost is high.
The invention also provides an in vitro evaluation method for the hemostatic performance of the dressing, which comprises the following steps: the blood flow rate reduction rate of the blood flowing through the dressing is measured by constant negative pressure suction by an analytical balance and a test model mechanism, and d ═ Vi－Vf) The formula of/t processes data; in the formula: d-flow reduction, micrograms per square second (. mu.g/s)2)；Vi-initial flow rate, micrograms per second (μ g/s); vf-final flow rate, micrograms per second (μ g/s); t — the time interval between the initial flow and the final flow is 30s, seconds(s).
Wherein the constant negative pressure suction is-4 kPa +/-0.1 kPa.
Compared with the prior art, the in vitro evaluation method for the hemostatic performance of the dressing has the same advantages as the in vitro evaluation system for the hemostatic performance of the dressing, and the detailed description is omitted.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.
FIG. 1 is a schematic structural diagram of an in-vitro evaluation system for hemostatic performance of a dressing provided by an embodiment of the invention;
FIG. 2 is a schematic structural diagram of a disposable sample holding device of a test model mechanism in an in vitro evaluation system for hemostatic performance of a dressing provided by an embodiment of the present invention;
FIG. 3 is a schematic structural diagram of a spring ball-in-ball mounting structure of a test model mechanism in the in-vitro evaluation system for hemostasis performance of a dressing provided by the embodiment of the invention;
fig. 4 is a schematic structural diagram of a rapid lifting device of a test model mechanism in an in vitro evaluation system for hemostatic performance of a dressing provided by an embodiment of the invention;
FIG. 5 is a schematic structural diagram of a bubbler in the in-vitro evaluation system for hemostatic performance of a dressing provided by the embodiment of the invention;
fig. 6 is a schematic structural diagram of an airflow dryer and a bubble counter in the in-vitro evaluation system for hemostatic performance of a dressing according to an embodiment of the present invention.
In the figure: 1-analytical balance; 2-a test model mechanism; 3-a bubble counter; 4-biological isolation air filter; 5-an air flow dryer; 51-a desiccant; 6-operating the touch device; 7-a data processing device; 21-a disposable sample holding device; 211-a blood container; 212-a disposable syringe; 213-injection needle; 22-spring ball-catch mounting and clamping structure; 221-installing the card body; 222-a compression spring; 223-steel ball; 23-a fast lifting device; 231-a rack; 232-gear; 233-locking the bolt.
Detailed Description
The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; the connection can be mechanical connection or electrical connection; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.
Fig. 1 is a schematic structural diagram of an in-vitro evaluation system for hemostatic performance of a dressing provided by an embodiment of the invention.
As shown in fig. 1, an embodiment of the present invention provides an in vitro evaluation system for hemostatic performance of a dressing, including: the device comprises an analytical balance 1, wherein a test model mechanism 2 for measuring the flow rate reduction rate of blood flowing through a dressing is arranged on the analytical balance 1, the test model mechanism 2 is communicated with a plurality of bubble making devices 3 through a suction pipeline, and the front end of the suction pipeline is connected with a biological isolation air filter 4 in series; the air flow dryer 5, the air flow dryer 5 is integrated with the bubble counter 3, and a drying agent 51 is filled in a drying cavity of the air flow dryer 5; an operation touch device 6, wherein the operation touch device 6 is connected with the airflow dryer 5, and the operation touch device 6 is used for executing the constant negative pressure suction operation; and the data processing device 7 is connected with the analytical balance 1 and the operation touch device 6 respectively, and the data processing device 7 is used for acquiring and processing data and outputting the result.
Compared with the prior art, the dressing hemostasis performance in-vitro evaluation system provided by the embodiment of the invention has the following advantages:
the in-vitro evaluation system for the dressing hemostasis performance provided by the embodiment of the invention comprises the following components: analytical balance 1, air dryer 5, operating touch device 6, and data processing device 7; the analytical balance 1 is provided with a test model mechanism 2 for measuring the flow rate reduction rate of blood flowing through the dressing, the test model mechanism 2 is communicated with a plurality of bubble devices 3 through a suction pipeline, and the front end of the suction pipeline is connected with a biological isolation air filter 4 in series; specifically, the airflow dryer 5 is integrated with the bubble counter 3, and a drying cavity of the airflow dryer 5 is filled with a drying agent 51; further, the operation touch device 6 is connected to the air flow dryer 5, and the operation touch device 6 is used for execution of the constant negative pressure suction operation; the data processing device 7 is respectively connected with the analytical balance 1 and the operation touch device 6, and the data processing device 7 is used for collecting and processing data and outputting the result. Therefore, the in-vitro evaluation system for the hemostatic performance of the dressing provided by the embodiment of the invention can be used for in-vitro evaluation and detection of the hemostatic performance of the dressing, so that various problems existing in the existing evaluation and detection by using an animal model are solved, and particularly, the evaluation and detection results are inaccurate due to the difference between a test animal and a human body; the consumption of experimental animals is not beneficial to animal protection; the experimental design is relatively complex, the result cannot be quantized, and the hemostatic performance of the dressing is difficult to compare; the evaluation and detection cost is high.
In the system for evaluating the hemostatic performance of the dressing in vitro provided by the embodiment of the invention, the biological isolation air filter 4 is a hydrophobic filter; the drying agent 51 in the airflow dryer 5 is water-absorbing silica gel; the constant negative pressure suction operation was-4 kPa. + -. 0.1 kPa.
Fig. 2 is a schematic structural diagram of a disposable sample clamping device of a test model mechanism in an in vitro evaluation system for hemostatic performance of a dressing provided by an embodiment of the invention.
In practical applications, as shown in fig. 2, the test model mechanism 2 may include: a disposable sample holding device 21, the disposable sample holding device 21 may include: a blood container 211 containing human whole blood, and a disposable syringe 212 containing a test sample or a control sample; the disposable syringe 212 is connected to an injection needle 213, and the injection needle 213 is inserted into the whole human blood in the blood container 211.
It should be added here that since the test uses contact blood, if the sample holding device in the test model is repeatedly used, it will be at risk to the biological safety of the testing personnel; therefore, the design considers that disposable consumables with high availability are adopted, and a disposable syringe with the specification of 1mL is finally determined as a clamping device of the hemostatic material sample through repeated demonstration and discussion; and the specification of the communicated injection needle is 0.2 mm-0.3 mm.
Fig. 3 is a schematic structural diagram of a spring ball-in-ball mounting structure of a test model mechanism in the dressing hemostasis performance in-vitro evaluation system provided by the embodiment of the invention.
As shown in fig. 3, the test model mechanism 2 may further include: a spring ball-on-ball mounting structure 22, the spring ball-on-ball mounting structure 22 being capable of holding a disposable syringe 212. The spring ball-touching type clamping design is adopted, the sample clamping device can be assembled and disassembled by a single hand, the left hand and the right hand can be operated, the convenience of operation is improved, and meanwhile, the stability in the test process is ensured.
Specifically, as shown in fig. 3, the spring ball mounting structure 22 may include: the disposable injector 212 clamping device comprises a clamping body 221, wherein the clamping body 221 is provided with an accommodating groove for clamping the disposable injector 212, the clamping body 221 is also provided with a groove which is vertical to and communicated with the accommodating groove, and a compression spring 222 is arranged in the groove; one end of the compression spring 222 is connected with the groove, the other end is connected with a steel ball 223, and the steel ball 223 is arranged in contact with the disposable syringe 212.
Further, as shown in fig. 3, three groups of receiving grooves and grooves may be formed in the card mounting body 221 at intervals, and a pair of compression springs 222 and steel balls 223 are installed in each group of grooves, so that the spring ball-in-ball card mounting structure 22 can simultaneously mount three disposable syringes 212, thereby effectively improving the inspection efficiency.
Fig. 4 is a schematic structural diagram of a rapid lifting device of a test model mechanism in the in-vitro evaluation system for hemostasis performance of a dressing provided by the embodiment of the invention.
Further, as shown in fig. 4, the test model mechanism 2 may further include: a fast lifting device 23, the fast lifting device 23 being located above the analytical balance 1; the rapid elevating device 23 may include: a rack 231, and a gear 232 engaged with the rack 231; during the specific assembly, the spring ball-catch mounting and clamping structure 22 is connected with the gear 232 and can move up and down along the rack 231, so that the heights of the spring ball-catch mounting and clamping structure 22 and the disposable injector 212 can be quickly adjusted.
Still further, the fast lifting device 23 may further include: a locking bolt 233, the locking bolt 233 being used to lock and secure the spring catch ball mounting structure 22 after it is at the proper height.
FIG. 5 is a schematic structural diagram of a bubbler in the in-vitro evaluation system for hemostatic performance of a dressing provided by the embodiment of the invention; fig. 6 is a schematic structural diagram of an airflow dryer and a bubble counter in the in-vitro evaluation system for hemostatic performance of a dressing according to an embodiment of the present invention.
Preferably, as shown in fig. 5 and 6, the bubble counter 3 may be a negative pressure bubble counter, and the counting mode may be photoelectric counting, so as to automatically check the smoothness of the microporous needle tube.
Certainly, in the system for evaluating the hemostatic performance of the dressing in vitro provided by the embodiment of the present invention, the bubble counter 3 may also be manually counted; the working principle is that before the test needle is not inserted into blood, the needle is subjected to air suction under-4 kPa, bubbles in a bubble reading cavity in the device are observed visually, the time of 10 bubbles is recorded manually by a stopwatch, and the needle which does not bubble or slowly bubbles is accurately judged as the 'blocked needle' and cannot be used for the test. The operation can effectively avoid the interference of invalid test data, and save the test time and blood consumption.
As shown in fig. 5 and 6, in order to prevent the moisture from entering the suction system, the air flow dryer 5 has a cavity filled with water-absorbing silica gel, and the air flowing through the cavity turns in a curved path above the silica gel to dry the silica gel sufficiently, so as to effectively prevent the moisture in the moisture from being sucked into the suction system.
It should be added that, in the system for evaluating hemostatic performance of a dressing in vitro according to the embodiments of the present invention, in order to protect the system from biological contamination, the hydrophobic air filter is connected in series to the front end of the suction line, so that blood can be effectively prevented from being accidentally sucked into the suction system.
In addition, the panel of the host computer operating the touch device 6 is provided with a start key (starting to suck negative pressure after being touched) and a timing key which are operated by a mouse attached to a computer, and the transparent injector and the injection needle seat can realize that the instrument starts to record after the mouse keyboard is touched by hands at the moment when blood contacts a test sample.
The embodiment of the invention also provides an in-vitro evaluation method for the hemostatic performance of the dressingThe method comprises the following steps: the blood flow rate reduction rate of the blood flowing through the dressing is measured by constant negative pressure suction by an analytical balance and a test model mechanism, and d ═ Vi－Vf) The formula of/t processes data; in the formula: d-flow reduction, micrograms per square second (. mu.g/s)2)；Vi-initial flow rate, micrograms per second (μ g/s); vf-final flow rate, micrograms per second (μ g/s); t — the time interval between the initial flow and the final flow is 30s, seconds(s).
Wherein the constant negative pressure suction is-4 kPa + -0.1 kPa.
The system and the method for evaluating the hemostatic performance of the dressing in vitro provided by the embodiment of the invention meet the following requirements:
firstly, the biological safety requirement is as follows: the humanized design is adopted, the sample is convenient to load and unload, and the risk of blood pollution to the test system is in an acceptable range; the risk of accidental needle sticks is within acceptable limits;
II, operation requirements are as follows: a reliable lifting system; the panel of the host computer is provided with a starting key (starting to suck negative pressure after being touched) and a timing key (starting to time the instrument after the instant blood is observed to contact with the test sample is touched);
thirdly, the automation requirement is as follows: after the time key was turned on, the instrument was automatically stopped after recording and running for 90s + -0.5, recording the mass loss for the first 30s and the last 30s, respectively, automatically displaying and/or printing the results (difference between the flow for the first 30s and the last 30s, divided by the total time) and, in μ g/s2Or μ L/s2(conversion of weight counts to volume readings by blood density) as units;
fourthly, the stability requirement of the negative pressure suction source is as follows: outputting negative pressure suction of-4 kPa +/-0.5 kPa;
fifthly, the screening function requirement of the injection needle is as follows: the host machine is provided with an interface for screening gas of the injection needle, and can judge whether the inner cavity of the injection needle is smooth and/or meet the test requirements;
sixthly, the electrical safety requirement is as follows: part 1 of the safety requirements for electrical equipment for measurement, control and testing, which are GB in 4793.1: general requirements.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.
Claims (8)
1. An in vitro evaluation system for hemostatic performance of a dressing, comprising:
the device comprises an analytical balance, a plurality of bubble devices and a biological isolation air filter, wherein the analytical balance is provided with a test model mechanism, the analytical balance and the test model mechanism are used for measuring the flow rate reduction rate of blood flowing through a dressing, the test model mechanism is communicated with the bubble devices through an attraction pipeline, and the front end of the attraction pipeline is connected in series with the biological isolation air filter;
the air flow dryer is integrated with the bubble counting device, and a drying cavity of the air flow dryer is filled with a drying agent;
the operation touch device is connected with the airflow dryer and is used for executing constant negative pressure suction operation;
the data processing device is respectively connected with the analysis antenna and the operation touch device and is used for acquiring and processing data and outputting results;
the test model mechanism comprises: a disposable sample holding device, the disposable sample holding device comprising: a blood container containing human whole blood, and a disposable syringe containing a test sample or a control sample;
the disposable syringe is communicated with an injection needle, and the injection needle extends into the human whole blood in the blood container;
the bubble counting device is a negative pressure bubble counter, and the counting mode is photoelectric counting.
2. The in vitro evaluation system of hemostatic performance of a dressing according to claim 1, wherein the test model mechanism further comprises: the spring ball-touching clamping structure is used for clamping the disposable syringe.
3. The in vitro evaluation system for hemostatic performance of a dressing according to claim 2, wherein the spring-ball mounting and clamping structure comprises: the disposable syringe comprises a card body, a clamping head and a clamping head, wherein the card body is provided with an accommodating groove for clamping the disposable syringe, the card body is also provided with a groove which is perpendicular to and communicated with the accommodating groove, and a compression spring is arranged in the groove;
one end of the compression spring is connected with the groove, the other end of the compression spring is connected with a steel ball, and the steel ball is in contact with the disposable injector.
4. The dressing hemostasis performance in-vitro evaluation system of claim 3, wherein three groups of accommodating grooves and grooves are arranged on the clamping body at intervals, and a pair of compression springs and steel balls are arranged in each group of grooves.
5. The in vitro evaluation system of hemostatic performance of a dressing of claim 2, wherein the test model mechanism further comprises: a fast lifting device located above the analytical balance;
the quick lifting device comprises: a rack and a gear engaged with the rack; the spring ball-touching clamping structure is connected with the gear and can move up and down along the rack.
6. The in vitro evaluation system of the hemostatic performance of a dressing according to claim 5, wherein the rapid lifting device further comprises: and the locking bolt is used for locking and fixing the spring ball-bumping clamping structure after the spring ball-bumping clamping structure is at a proper height.
7. An in vitro evaluation method for the hemostatic performance of a dressing is characterized in that an analytical balance is provided with a test model mechanism, and a blood container in the test model mechanism is placed on the analytical balance; the test model mechanism comprises: disposable test sample clampA holding device, the disposable sample holding device comprising: a blood container containing human whole blood, and a disposable syringe containing a test sample or a control sample; the disposable syringe is communicated with an injection needle, and the injection needle extends into the human whole blood in the blood container; the blood flow rate reduction rate of the blood flowing through the dressing is measured by constant negative pressure suction by an analytical balance and a test model mechanism, and d ═ Vi－Vf) The formula of/t processes data; in the formula:
d-rate of flow reduction, micrograms per square second (. mu.g/s)2)；
Vi-initial flow rate, micrograms per second (μ g/s);
Vf-final flow rate, micrograms per second (μ g/s);
t — the time interval between the initial flow and the final flow is 30s, seconds(s).
8. The in vitro evaluation method of the hemostatic performance of the dressing according to claim 7, wherein the constant negative pressure suction is-4 kPa ± 0.1 kPa.
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