CN202620371U - Blood return test device - Google Patents

Abstract

The utility model discloses a blood return test device provided with a vein simulation device. A syringe needle of a transfusion leather strip can be pricked in the vein simulation device. The transfusion leather strip is provided with a transducer, the diameter of which is larger than that of the transfusion leather strip. The transducer is horizontally arranged, and is provided with a transparent liquid column, which is communicated with the transducer and is vertically arranged. By adopting the above mentioned technical scheme, devices and methods used for testing whether the blood is returned by using transfusion bottles or transfusion bags made of different materials can be provided. In the utility model, the scientificalness of test devices and test methods can be verified by conducting tests on the various transfusion bottles and bags made of different materials. The test data and conclusion about whether the blood is returned by using the product can be obtained by examining the transfusion of the injection stretch blow seamless transfusion bag with the verified test devices and test methods, therefore the basis of setting the quality standard of the transfusion bags can be provided.

Description

The bleedback test device

Technical field

This utility model belongs to technical field of medical, relates to the technology of transfusion apparatus test, and more particularly, this utility model relates to a kind of bleedback test device.

Background technology

What determine fluid flow direction is fluidic total mechanical energy, and fluid always flows to the low place of total mechanical energy from the high place of total mechanical energy.Mechanical energy in the process fluid flow has potential head z (z is the position of medicinal liquid), (p is the pressure of medicinal liquid to hydrostatic head

; ρ is the density of medicinal liquid; G is an acceleration of gravity), dynamic head

(u is the flow velocity of medicinal liquid); Itself and for total mechanical energy

if total mechanical energy of infusion pipeline herb liquid is higher than total mechanical energy of venous blood, then medicinal liquid can be delivered in the blood vessel and can blood back.

In order to measure total mechanical energy of infusion pipeline herb liquid, in the experimental provision of design, adopt the diameter transducer more much bigger, because the incompressible fluid equation of continuity than leather strap diameter

Restriction, when the cross-sectional area A of transducer ₂Sectional area A much larger than leather strap ₁The time can the flow velocity of transducer herb liquid be regarded as zero, if be the z=0 at zero point of position, can get by bernoulli equation with the center of transducer:

The dynamic head of medicinal liquid in leather strap all is converted into hydrostatic head in transducer, therefore, the liquid-column height that on transducer, records has in fact just been represented total mechanical energy of this place's liquid.

Because the pressure from the transducer to the syringe needle falls identical with a kind of fluid; The liquid-column height that relatively records on the transducer is consistent with the total mechanical energy that compares the syringe needle place; Therefore, in experiment, be standard with the liquid-column height value 24cm water column that records on the soft bag of glass infusion bottle, plastic infusion bottle and the multilamellar transducer with through simulation vein blood vessel device; When medicinal liquid drips to luxuriant luxuriant and rich with fragrance dropper bottom the time, medicinal liquid still can flow out from the vein blood vessel analog; Or drip to luxuriant luxuriant and rich with fragrance dropper bottom the time when medicinal liquid, and the liquid-column height that links to each other with transducer is not less than the 24cm water column, and one of above-mentioned two kinds of situation show that transfusion can blood back.

The at present both at home and abroad all also device of ideal bleedback test and corresponding bleedback test method without comparison.Generally all be to adopt zoopery checking blood back situation.Because zoopery has certain limitation, receive the individual influence that changes of experiment, the concordance and the reproducibility of experimental data are poor; And widely different between human body and the laboratory animal, its experimental data is difficult on the human body to be verified, also is difficult to its apparatus and method are applied in people's the medical treatment.

Therefore, can be applied to the bleedback test device and the bleedback test method thereof of human body, for infusion products

Design, exploitation and production application are of crucial importance and urgent.Through retrieval, invent according to the equation principle and to verify that whether the method and apparatus of blood back is not seen as yet.

The utility model content

This utility model provides a kind of bleedback test device; Can infusion bottle or the transfusion bag that its objective is check and judge Different Package material blood back whether in infusion process promptly detect packaging material such as transfusion, blood transfusion and under airtight situation, import automatically in the life entity of being correlated with.

To achieve these goals, the technical scheme taked of this utility model is:

The bleedback test device that this utility model provided; Comprise infusion bottle or transfusion bag, transfusion leather strap, Murphy type burette, drip fast actuator; Connect by the transfusion standard; Described bleedback test device is established the vein blood vessel analog, and the syringe needle on the described transfusion leather strap penetrates described vein blood vessel analog; The transducer of diameter greater than the transfusion leather strap is set on described transfusion leather strap, and described transducer horizontal positioned is established transparent fluid column on the described transducer, is communicated with described transducer and erects setting.

Described bleedback test device also is provided with scale, and described scale is vertically placed.

The overflow pipe that described vein blood vessel analog is provided with rubber glue head and vertically is provided with.The height of described overflow pipe is 22cm～23cm.

The center line horizontal positioned of described transducer, and the center line of the bottom of the bottom of rubber glue head and scale and transducer is set to the height such as grade.

This utility model also provides the bleedback test method of above-described bleedback test device, and the test procedure that its technical scheme of taking is this method is:

1, will infuse leather strap through syringe needle insertion infusion bottle or transfusion bag, the vertical dimension of the bottleneck of infusion bottle or the bag mouth of transfusion bag and transducer is 0.5～1.5m;

2, the part air in the discharge Murphy type burette, and adjusting medicinal liquid height is 1cm～2cm; Described medicinal liquid height is the distance of liquid level to the Murphy type burette end opening;

3, discharge the interior air of transducer, and the horizontal central line of transducer is fixed on the place at zero point of described bleedback test device;

4, syringe needle is inserted on the glue head of vein blood vessel analog;

A speed of 5, regulating medicinal liquid is at 60～70/min;

6, measure:

The liquid level of the fluid column that links to each other with transducer;

And measure liquid level value h in infusion bottle or the transfusion bag Chinese medicine drop fluid column when infusing the leather strap port ₁, liquid level value h in the fluid column when medicine liquid droplet to the Murphy type burette of transfusion in the leather strap is suitable for reading ₂Liquid level value h in the fluid column during with medicine liquid droplet to Murphy type burette end opening ₃

The Rule of judgment of described bleedback test method is:

When medicinal liquid dripped to the Murphy type burette end opening, medicinal liquid still can flow out from the vein blood vessel analog; Or when medicine liquid droplet to Murphy type burette end opening, be not less than 24cm with the reading of liquid level value in the fluid column that described transducer links to each other, and showing that product meets the requirements, transfusion can blood back.

Being determined as of said speed: press stopwatch writing time, number goes out to get into the number that drips of medicinal liquid in the Murphy type burette in one minute.

The injection that described bleedback test method adopts is the basis transfusion.

This utility model adopts technique scheme; Infusion bottle or the transfusion bag that check Different Package material is provided whether assay device and bleedback test method of blood back in infusion process; The science of demonstration test device, test method is tested in basis transfusion so that vial, use air inlet transfusion device plastic bottle, the plastic bag (using non-air inlet transfusion device) of PP TYPE are packed on assay device as material; With the transfusion of the basis of multilamellar packed in flexible pouchy is that material (using non-air inlet transfusion device) is tested on assay device, proposes to judge polypropene blended transfusion bag critical parameter of blood back whether in infusion process; Adopt device and test method after the checking to check polypropene blended transfusion bag, obtain test data and conclusion that this product whether can blood back; For working out the transfusion bag quality standard foundation is provided.

Description of drawings

The labelling of facing down among expressed content of each width of cloth accompanying drawing of this description and the figure is made brief description:

Fig. 1 is the structural representation of this utility model;

Fig. 2 is the structural representation of vein blood vessel analog.

Be labeled as among the figure:

1, transfusion leather strap, 2, Murphy type burette is suitable for reading, 3, Murphy type burette, 4, the Murphy type burette end opening, 5, transducer, 6, the vein blood vessel analog, 7, fluid column, 8, scale, 9, infusion bottle, 10, drip fast actuator, 11, transfusion leather strap port.

The specific embodiment

Contrast accompanying drawing below,, the specific embodiment of the utility model is described in further detail, inventive concept, the technical scheme of the utility model are had more complete, accurate and deep understanding to help those skilled in the art by description to embodiment.

Like the structure of the expressed this utility model of Fig. 1, be a kind of bleedback test device, comprise infusion bottle 9 or transfusion bag, transfusion leather strap 1, Murphy type burette 3, drip fast actuator 10, connect by the transfusion standard.

One, the bleedback test principle of this utility model:

What determine fluid flow direction is fluidic total mechanical energy.Fluid always flows to the low place of total mechanical energy from the high place of total mechanical energy.Mechanical energy in the process fluid flow has potential energy (also claiming potential energy): z (z is the position of medicinal liquid), hydrostatic head:

(p is the pressure of medicinal liquid; ρ is the density of medicinal liquid; G is an acceleration of gravity), dynamic head (also claiming kinetic energy):

(u is the flow velocity of medicinal liquid), its summation is total mechanical energy:

$E=z+\frac{p}{\mathrm{\ρg}}+\frac{u^2}{2g}$

If total mechanical energy of infusion pipeline herb liquid is higher than total mechanical energy of venous blood, then medicinal liquid can be delivered in the blood vessel, and blood back can not take place.

Two, assay device:

In order to solve the problem that exists at the described present known technology of this description background technology part and to overcome its defective; Infusion bottle or the transfusion bag that realizes check and judge Different Package material blood back whether in infusion process; Can detect packaging material such as transfusion, blood transfusion in other words and under airtight situation, import the goal of the invention in the relevant life entity automatically, the technical scheme that this utility model is taked be:

As shown in Figure 1, the bleedback test device that this utility model provided is established vein blood vessel analog 6, and the syringe needle on the described transfusion leather strap 1 penetrates described vein blood vessel analog 6; The transducer 5 of diameter greater than transfusion leather strap 1 is set on described transfusion leather strap 1, and described transducer 5 horizontal positioned are established transparent fluid column 7 on the described transducer 5, are communicated with described transducer 5 and erect setting.

Described fluid column 7 generally can adopt tube for transfusion, is transparent straight pipe.

In order to measure total mechanical energy of infusion pipeline herb liquid, in the experimental provision that this utility model provides, adopt diameter than the much bigger transducer 5 of transfusion leather strap 1 diameter.

Owing to receive the incompressible fluid equation of continuity

Restriction, when the cross-sectional area A of transducer 5 ₂Sectional area A much larger than transfusion leather strap 1 ₁The time, can be with the flow velocity u of transducer 5 herb liquids ₂Being regarded as zero, is the z=0 at zero point of position as if the center with transducer 5, can be got by Bernoulli equation:

The dynamic head of medicinal liquid in transfusion leather strap 1 all is converted into hydrostatic head in transducer 5, therefore, and the liquid-column height that on transducer 5, records In fact just total mechanical energy of having represented this place's liquid.

Owing to drip under the speed certain; Pressure from transducer 5 to syringe needle falls identical with a kind of fluid; The liquid-column height that relatively records on the transducer 5 is consistent with the total mechanical energy that compares the syringe needle exit; Therefore, the liquid-column height that can record with transducer 5, and can medicinal liquid through vein blood vessel analog 6 for judging the standard of blood back of whether infusing.

Described bleedback test device also is provided with scale 8, and described scale 8 is vertically placed.Described scale 8 is used for confirming bottleneck or the bag mouth of transfusion bag and the vertical dimension of transducer 5 of infusion bottle 9, generally adopts the rigidity ruler.

Overflow pipe as shown in Figure 2, that described vein blood vessel analog 6 is provided with rubber glue head and vertically is provided with.The height of described overflow pipe is 22cm～23cm.

Central venous pressure normal value 5cm～12cm water column of people, people's peripheral venous pressure is less than central venous pressure.For safe reliable, by about twice of the normal value upper limit, the design static pressure is that 22cm～23cm water column is the pressure of vein blood vessel analog 6.If total mechanical energy of syringe needle exit medicinal liquid is greater than the static pressure at this place; Then medicinal liquid can pass through this device smoothly; Show that transfusion can be smoothly normally accomplishes, therefore whether can from the vein blood vessel analog 6 of design, flow out as whether the basis for estimation of blood back is rational with medicinal liquid.

The center line horizontal positioned of described transducer 5, and the center line of the bottom of the bottom of rubber glue head and scale 8 and transducer 5 is set to the height such as grade.

Three, bleedback test method:

This utility model also provides the bleedback test method of above-described bleedback test device, and its technical scheme of taking requires to adopt the infusion bottle and the transfusion bag of different materials, different size a plurality of.

The test procedure of this method is:

1, will infuse leather strap 1 through syringe needle insertion infusion bottle 9 or transfusion bag, the vertical dimension of the bottleneck of infusion bottle 9 or the bag mouth of transfusion bag and transducer 5 is 0.5～1.5m;

2, the part air in the discharge Murphy type burette 3, and adjusting medicinal liquid height is 1cm～2cm; Described medicinal liquid height is the distance of liquid level to Murphy type burette end opening 4;

3, discharge air in the transducer 5, and the horizontal central line of transducer 5 is fixed on the place at zero point of described bleedback test device;

4, syringe needle is inserted on the glue head of vein blood vessel analog 6;

A speed of 5, regulating medicinal liquid is at 60～70/min;

6, measure:

The liquid level of the fluid column 7 that links to each other with transducer 5;

And measure liquid level value h in infusion bottle 9 or the transfusion bag Chinese medicine drop fluid column 7 when infusing leather strap port 11 ₁, in medicine liquid droplet to the Murphy type burette of transfusion in the leather strap 1 fluid column 72 time suitable for reading liquid level value h ₂Liquid level value h in the fluid column 7 during with medicine liquid droplet to Murphy type burette end opening 4 ₃

The Rule of judgment of described bleedback test method is:

When medicinal liquid dripped to Murphy type burette end opening 4, medicinal liquid still can flow out from vein blood vessel analog 6; Or when medicine liquid droplet to Murphy type burette end opening 4, the reading of liquid level value is not less than 24cm in the fluid column 7 that links to each other with described transducer 5, shows that product meets the requirements, and transfusion can blood back.

Owing to is material with glass infusion bottle, plastic infusion bottle and multi-layer co-extruded film soft bag infusion solutions, in experiment, record medicinal liquid and drip to Murphy type burette 3 bottom the time, medicinal liquid still can flow out from vein blood vessel analog 6; Multi-layer co-extruded film soft bag is packaging material simultaneously, and when liquid-column height 24cm water column, medicinal liquid still can flow out from vein blood vessel analog 6.From quantitative angle analysis, can be not less than the 24cm water column as basis for estimation that can blood back in the infusion process with liquid-column height.

Therefore, judge that the criterion that transfusion can blood back has: liquid-column height be not less than 24cm water column and medicinal liquid can pass through vein blood vessel analog 6 both one of.

Being determined as of said speed: press stopwatch writing time, number goes out to get into the number that drips of medicinal liquid in the Murphy type burette 3 in one minute.

The injection that described bleedback test method adopts is the basis transfusion, comprises sodium chloride injection etc.Because of sodium chloride injection is one of clinical most popular kind, so the selective chlorination sodium injection is a testing liquid.

Four, test material:

Vial, plastic bottle, PP TYPE bag transfusion sample are Anhui Double-Crane Pharmaceutical Co., Ltd company limited finished product, and annotating the seamless transfusion bag of stretch blow is the product of producing according to the infusion solutions product preparation process.Each 30 of specification preparation of the said goods is subsequent use.Might not all use in the experiment.

Table 1, test material catalog

Five, experimental data:

Clinical widely used transfusion package container is glass infusion bottle, plastic infusion bottle (using the air inlet transfusion device) and PP TYPE bag (using non-air inlet transfusion device); Their anti-clinically blood back effects gain public acceptance, so be the material foundation that device, bleedback test method and blood back criterion set up that makes an experiment with glass infusion bottle, plastic infusion bottle and PP TYPE bag.

1, glass infusion bottle, plastic infusion bottle sample experimental result:

In the experiment, when the vial not bubbling air of infusing, medicinal liquid can not flow out from vein blood vessel analog 6, therefore must adopt the air inlet transfusion device.Control medicine liquid droplet speed is 60～70/min, record h ₁, h ₂, h ₃Numerical value.

Experimental data sees Table 2, table 3.

Table 2, glass bottle sodium chloride injection experimental data

Table 3, plastic bottle sodium chloride injection experimental data

Above experimental data is the data that different laboratory technicians records on same experimental provision, and same laboratory technician records on different device.Test data changes within the specific limits.Main cause is: along with the carrying out of transfusion, liquid height reduces in the bottle, and dripping speed must reduce, and must control through manual work to drip speed at 60～70 droplets/minute.It is to be undertaken by stopwatch, several numbers by the experimenter that speed is dripped in artificial control, has certain error.Owing to drip speed 60～70 droplets/minute changes; It is different to drip speed; Then flow velocity is also different; Dynamic head

is also different, thereby drips the value that speed influences liquid-column height .

Experimental result shows that medicinal liquid can pass through vein blood vessel analog 6 smoothly, and therefore, can judge can blood back.

Experimental data also shows, no matter to vial or plastic bottle, and liquid-column height h ₁, h ₂, h ₃All in a narrower scope, change, the repeatability of illustrative experiment data is higher, and medicinal liquid can pass through vein blood vessel analog 6 smoothly simultaneously.Explained that the liquid-column height that records with experiment and medicinal liquid can be through vein blood vessel analog 6 as bases for estimation, judged that the method that transfusion can blood back is that science is feasible.

2, PP TYPE transfusion bag sample experimental result:

Non-gas formula transfusion device is adopted in the transfusion of PP TYPE bag, and relevant experimental data sees Table 4.

Table 4, the PP TYPE packed sodium chloride injection experimental data of infusing

Table 4 data show, the h of PP TYPE transfusion bag ₁, h ₂, h ₃The liquid-column height value is less than glass infusion bottle and plastic bottle.

The reason that above-mentioned phenomenon produces is: when using glass infusion bottle and plastic bottle, leave air intake, the pressure perseverance at the air intake place is an atmospheric pressure, and this is the Ma Liaote vessel characters.Pressure perseverance before transfusion finishes above the liquid level is an atmospheric pressure; And not having air admission, the soft bag of multilamellar in infusion process, will deform when using the soft bag of multilamellar to infuse, the pressure of liquid level top is less than atmospheric pressure, makes the data that the record liquid-column height less than glass infusion bottle and plastic bottle; The distortion of PP TYPE transfusion bag can occur on the different directions, and the aspect effect flow of distortion causes the h that uses Different Individual PP TYPE transfusion bag to record ₁, h ₂, h ₃Variation bigger.

Under normal conditions, when medicinal liquid was transported to transfusion leather strap port 11, infusion process finished.Both made the requirement of considering especial patient, the medicinal liquid in the Murphy type burette 3 drips off, and transfusion must finish, so, with h ₃As judging in the infusion process that whether the basis for estimation of blood back is suitable.

Because of the anti-blood back effect of PP TYPE transfusion flexible bag gains public acceptance, and experiment shows that when the 24cm water column appearred in the liquid-column height when the multi-layer co-extruded film soft bag infusion solutions drips to Murphy type burette end opening 4, medicinal liquid can pass through vein blood vessel analog 6 smoothly.Given this, be standard with the 24cm water column, promptly liquid-column height can blood back more than 24cm.

Six, conclusion:

1, through the various transfusion package materials of check, above-mentioned the assay device and the test method of blood back are that science is feasible in infusion process;

2, with the 24cm water column as judge to annotate the seamless transfusion bag of stretch blow in infusion process whether the critical parameter of blood back be reliably, having obtained fluid can be through the evidence of vein blood vessel analog 6.

Seven, relevant explanation:

In the determinator, the relative position that changes various piece can make the liquid-column height h that records ₁, h ₂, h ₃Certain difference is arranged; Needle position is low, and then data are little; Needle position is high, and then data are big.

Combine accompanying drawing that this utility model has been carried out exemplary description above; Obviously the concrete realization of this utility model does not receive the restriction of aforesaid way; As long as adopted the method design of this utility model and the improvement of the various unsubstantialities that technical scheme is carried out; Or the design of this utility model and technical scheme are directly applied to other occasion without improving, all within the protection domain of this utility model.

Claims (5)

1. bleedback test device; Comprise infusion bottle (9) or transfusion bag, transfusion leather strap (1), Murphy type burette (3), drip fast actuator (10); Connect by the transfusion standard; It is characterized in that: described bleedback test device is established vein blood vessel analog (6), and the syringe needle on the described transfusion leather strap (1) penetrates described vein blood vessel analog (6); The transducer (5) of diameter greater than transfusion leather strap (1) is set on described transfusion leather strap (1), and described transducer (5) horizontal positioned is established transparent fluid column (7) on the described transducer (5), is communicated with described transducer (5) and erects setting.

2. according to the described bleedback test device of claim 1, it is characterized in that: described bleedback test device also is provided with scale (8), and described scale (8) is vertically placed.

3. according to the described bleedback test device of claim 2, it is characterized in that: the overflow pipe that described vein blood vessel analog (6) is provided with rubber glue head and vertically is provided with.

4. according to the described bleedback test device of claim 3, it is characterized in that: the center line horizontal positioned of described transducer (5), and the center line of the bottom of the bottom of rubber glue head and scale (8) and transducer (5) is set to the height such as grade.

5. according to claim 3 or 4 described bleedback test devices, it is characterized in that: the height of described overflow pipe is 22cm～23cm.

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