1. A preparation method of a high-transparency elastic puncture catheter point liquid stopping and bleeding stopping device specifically comprises the following steps:

the method comprises the following steps: the mold is manufactured, the center of the mold is hemispherical, a groove which is transversely communicated is formed in the middle of the mold, the bottom of the groove is slightly wider than the top of the groove, a drainage pipe groove is formed in the side face of the groove, one end of the drainage pipe groove is connected with the through groove in the middle of the groove, and one end of the drainage pipe groove is communicated with the outer edge of the device.

Step two: adding medical high molecular material as raw material into injection machine, filling into mould, holding pressure, cooling, demoulding, and modifying and polishing to obtain the invented high-transparency elastic puncture tube point liquid-stopping and hemostatic device.

2. A method for preparing a puncture catheter insertion site liquid stopping and bleeding stopping device according to claim 1, which is characterized in that: the medical polymer material is a thermoplastic elastomer with the hardness of 40-70 degrees.

3. A method for preparing a puncture catheter insertion site liquid stopping and bleeding stopping device according to claim 1, which is characterized in that: the die is a hemispherical device, and the central hemispherical diameter of the die is 2-6 cm.

4. A method for preparing a puncture catheter insertion site liquid stopping and bleeding stopping device according to claim 1, which is characterized in that: the diameter of the bottom of the groove is 2 mm-5 mm.

5. A puncture catheter site fluid stopping and bleeding stopping device prepared by the method of any one of claims 1-4.

Background

The artery and vein puncture catheterization is two common clinical diagnosis and treatment means, has very wide application, is mainly suitable for various critical patients, complicated major operations and operations with major hemorrhage, extracorporeal circulation intracardiac direct vision, operations with low temperature and controlled blood pressure reduction, operations requiring repeated blood pressure measurement such as severe hypotension and shock, and the like, and patients needing continuous application of vasoactive drugs, and is generally selected from radial artery, brachial artery, axillary artery, instep artery, ulnar artery, femoral artery and the like, the central vein puncture catheterization generally selects internal and external jugular vein, subclavian vein, femoral vein and the like, is mainly suitable for critical patients needing large amount of rapid blood transfusion and fluid infusion, major operations of cardiovascular, craniocerebral and abdominal organs, patients needing long-term transfusion and difficult puncture of peripheral vein due to sclerosis and collapse, and can not measure urine volume or anuria, for patients needing central venous pressure measurement, after the patients are subjected to puncture catheterization, seepage or blood seepage is often easy to occur near the puncture point.

At present, the problem of seepage and bleeding is solved by means of gauze absorption, adhesive tape pressurization and the like, but the problem is not solved fundamentally by the method, the gauze adhesive tape needs to be replaced frequently, the cost is increased, and the puncture point is susceptible to infection and the like.

Disclosure of Invention

The invention mainly aims to provide a preparation method of a high-transparency elastic puncture catheter point liquid stopping and bleeding stopping device, which aims to solve the problems of seepage and bleeding and the like by means of gauze absorption, adhesive tape pressurization and the like in the prior art.

In order to achieve the purpose, the invention adopts the technical scheme that: a preparation method of a high-transparency elastic puncture catheter point liquid stopping and bleeding stopping device specifically comprises the following steps:

the method comprises the following steps: the mold is manufactured, the center of the mold is hemispherical, a groove which is transversely communicated is formed in the middle of the mold, the bottom of the groove is slightly wider than the top of the groove, a drainage pipe groove is formed in the side face of the groove, one end of the drainage pipe groove is connected with the through groove in the middle of the groove, and one end of the drainage pipe groove is communicated with the outer edge of the device.

Step two: adding medical high molecular material as raw material into injection machine, filling into mould, holding pressure, cooling, demoulding, and modifying and polishing to obtain the invented high-transparency elastic puncture tube point liquid-stopping and hemostatic device.

Preferably, the medical polymer material is a thermoplastic elastomer with the hardness of 40-70 degrees.

Preferably, the die is a hemispherical device, and the central hemispherical diameter of the die is 2 cm-6 cm.

Preferably, the diameter of the bottom of the groove is 2 mm-5 mm.

Preferably, the puncture catheterization point liquid stopping and bleeding stopping device prepared by the method in any one of the above steps.

Compared with the prior art, the technical scheme of the invention has the advantages that: the whole body of the invention is made of thermoplastic elastomer, is a common biomedical material, is nontoxic and harmless to human body, has high transparency, can observe the puncture point of a patient and check whether the patient seeps liquid and bleeds through the device, has high elasticity, can effectively play a role in stopping bleeding under the fixing action of the adhesive tape, can recover the original shape after the adhesive tape is removed, has excellent fatigue resistance, can be repeatedly bent for 100 times, has no obvious damage to the appearance of the device, still can effectively play a role in stopping liquid and stopping bleeding, and is not easy to cause the harm of infection and the like.

Drawings

Fig. 1 is a schematic structural view of the entire mold, with a top view on the left side and a side view on the right side.

Fig. 2 is a schematic structural diagram of two quarter-spheres after the mold is disassembled, wherein the left side is a top view, and the right side is a side view.

Fig. 3 is a schematic structural view of a T-shaped beam.

Fig. 4 is a schematic structural view of the sealing cover.

FIG. 5 is a graph showing the relationship between the hardness of a thermoplastic elastomer and the amount of liquid permeation.

Fig. 6 is a photograph of a device fabricated using a thermoplastic elastomer having a hardness of 60 degrees.

Fig. 7 is a graph showing the relationship between the hardness of the thermoplastic elastomer and the amount of liquid permeation after bending 100 times.

FIG. 8 is a graph showing the relationship between the diameter of the device and the amount of liquid permeation.

FIG. 9 is a photograph of a device having an overall diameter of 4 cm.

FIG. 10 is a graph showing the relationship between the diameter of the device and the amount of liquid leakage after bending 100 times.

FIG. 11 shows the relationship between the groove diameter and the amount of liquid leakage.

FIG. 12 is a photograph of a device with a 3mm slot diameter.

FIG. 13 shows the relationship between the groove diameter and the amount of liquid leakage after bending 100 times.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the schematic structural diagram of the present invention. It is to be understood that the described embodiments are only a few embodiments of the invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without any inventive step, are within the scope of the present invention.

A preparation method of a high-transparency elastic puncture catheter point liquid stopping and bleeding stopping device specifically comprises the following steps:

the method comprises the following steps: the mold is manufactured, the center of the mold is hemispherical, a groove which is transversely communicated is formed in the middle of the mold, the bottom of the groove is slightly wider than the top of the groove, a drainage pipe groove is formed in the side face of the groove, one end of the drainage pipe groove is connected with the through groove in the middle of the groove, and one end of the drainage pipe groove is communicated with the outer edge of the device.

Step two: adding medical high molecular material as raw material into injection machine, filling into mould, holding pressure, cooling, demoulding, and modifying and polishing to obtain the invented high-transparency elastic puncture tube point liquid-stopping and hemostatic device.

Further, the medical polymer material is a thermoplastic elastomer with the hardness of 40-70 degrees, and the hardness of the medical polymer material is optimally 60 degrees.

Further, the die is a hemispherical device, the central hemispherical diameter of the die is 2 cm-6 cm, and the optimal central hemispherical diameter of the die is 4 cm.

Further, the diameter of the bottom of the groove is 2 mm-5 mm, and the optimal diameter of the bottom of the groove is 3 mm.

Further, the puncture catheterization point liquid stopping and bleeding stopping device prepared by the method is provided.

Example 1:

1. base material: the matrix material used was a medical thermoplastic elastomer having a hardness of 40 degrees.

2. Preparing a mould: the overall structure of the die is as shown in figure 1, the die is of a detachable structure and mainly comprises four parts, namely two quarter balls (figure 2), a T-shaped cross beam (figure 3), a sealing cover (figure 4) and a hemisphere, wherein the two quarter balls are combined into the hemisphere, the T-shaped cross beam can be inserted into the hemisphere to be fixed, the hemisphere is sealed and fastened by the sealing cover, the diameter of the hemisphere is 2cm, a long beam in the T-shaped cross beam is U-shaped, the top of the T-shaped cross beam is slightly wider than the bottom of the T-shaped cross beam, four different sizes are manufactured respectively, and the diameter of the top of the T-shaped cross beam is 4 mm.

3. Respectively adding the medical thermoplastic elastomer serving as a raw material into an injection molding machine, performing hydrophobic treatment on the inner surface of a mold before injection molding, then performing injection molding on the raw material and filling the raw material into the mold, and performing pressure maintaining, cooling and demolding processes in sequence, and performing appropriate correction and polishing on the shape after demolding to obtain the high-transparency and high-elasticity puncture catheter insertion point liquid stopping and bleeding stopping device.

Example 2:

1. base material: the base materials used were medical thermoplastic elastomers having a hardness of 60 degrees.

2. Preparing a mould: the structure of the die is the same as that of embodiment 1, the sizes are different, the diameter of a hemisphere is 4cm, a long beam in a T-shaped cross beam is U-shaped, the top of the long beam is slightly wider than the bottom of the long beam, four different sizes are respectively manufactured, and the diameter of the top of the long beam is 3 mm.

3. Respectively adding the medical thermoplastic elastomer serving as a raw material into an injection molding machine, performing hydrophobic treatment on the inner surface of a mold before injection molding, then performing injection molding on the raw material and filling the raw material into the mold, and performing pressure maintaining, cooling and demolding processes in sequence, and performing appropriate correction and polishing on the shape after demolding to obtain the high-transparency and high-elasticity puncture catheter insertion point liquid stopping and bleeding stopping device.

Example 3:

1. base material: the base materials used were medical thermoplastic elastomers having a hardness of 70 degrees.

2. Preparing a mould: the structure of the die is the same as that of embodiment 1, the sizes are different, the diameter of a hemisphere is 6cm, a long beam in a T-shaped cross beam is U-shaped, the top of the long beam is slightly wider than the bottom of the long beam, four different sizes are respectively manufactured, and the diameter of the top of the long beam is 5 mm.

3. Respectively adding the medical thermoplastic elastomer serving as a raw material into an injection molding machine, performing hydrophobic treatment on the inner surface of a mold before injection molding, then performing injection molding on the raw material and filling the raw material into the mold, and performing pressure maintaining, cooling and demolding processes in sequence, and performing appropriate correction and polishing on the shape after demolding to obtain the high-transparency and high-elasticity puncture catheter insertion point liquid stopping and bleeding stopping device.

The research method comprises the following steps:

1. according to the device transparency test mode prepared in the examples: the prepared puncture catheter point liquid stopping and bleeding stopping device is placed on the paper surface, and characters on the paper surface are observed through the device, so that the content of the characters can be clearly identified, and the transparency is considered to be good.

2. According to the device prepared in the embodiment, the hemostasis effect test mode comprises the following steps: the infusion tube is penetrated through the device and fixed by the adhesive tape, then a certain pressure is applied to the liquid in the infusion tube, the pressure is about the human venous blood pressure, the infusion tube is placed for 2 hours, whether the liquid seeps out or not is observed, and the seeped liquid is weighed. The less the seepage, the better the liquid stopping effect.

3. The fatigue resistance test mode of the device prepared in the example: after continuously bending for 100 times, the transparency, the liquid stopping effect and the hemostatic effect of the device are tested again.

The research results are as follows:

1. effect of hardness of medical thermoplastic elastomer:

the medical thermoplastic elastomer with the hardness of 40 degrees, 50 degrees, 60 degrees and 70 degrees is selected as a raw material, the diameter of the bottom of the groove is 3mm, the diameter of the prepared hemostatic device is 3cm, and the influence of the hardness of the raw material on the performance of the hemostatic device is analyzed.

As can be seen from the observation, the medical thermoplastic elastomer has small influence on the transparency due to the hardness, and when the hardness is increased from 40 degrees to 70 degrees, the transparency is slightly reduced, but the text covered below can be clearly observed, so that the medical thermoplastic elastomer with each hardness has high transparency.

The infusion tube is passed through the liquid stopping and bleeding stopping devices with different hardness, then the devices are bent and fixed by using the adhesive tape, and liquid with certain pressure intensity is added into the infusion tube, and the pressure intensity is about the human venous blood pressure. After being placed for 2 hours, the seepage is weighed, and as a result, as shown in fig. 5, the liquid stopping and stopping device made of medical thermoplastic elasticity with the hardness of 40 degrees seeps a great deal of liquid and cannot be discharged through the drainage tube groove, which is mainly because the device hardness is too low to effectively compress the infusion tube, so that the infusion tube cannot be completely closed, and therefore a great deal of seepage occurs, when the hardness is respectively 50 degrees, 60 degrees and 70 degrees, a small amount of seepage also occurs, but the seepage can be discharged through the lateral drainage tube groove, and the seepage is the least when the hardness is 60 degrees, because when the hardness is 50 degrees, the infusion tube still cannot be completely closed, so that a small amount of seepage occurs, and when the hardness is 70 degrees, because the device is hard, a large force is required to bend the device, and the force applied by the adhesive tape is small, so that the liquid stopping and stopping device has a certain rebound after being bent, and therefore the infusion tube has a, as a result, the device made of the medical thermoplastic elastomer having a hardness of 60 degrees had the best hemostatic effect, as shown in fig. 6.

After the liquid stopping and hemostatic device is continuously bent for 100 times, the appearance is not obviously damaged, the transparency is slightly changed, a white crease appears in the middle, but certain transparency is still kept, the liquid stopping is carried out again, and the result after the hemostatic effect test is carried out is shown in fig. 7. It can be seen that the effect is not obviously changed, when the hardness is 60 degrees, a small amount of seepage is generated, but the seepage can be discharged through the side drainage pipe groove, and the drainage pipe can still be normally used.

2. Fluid stopping, influence of the diameter of the hemostatic device:

the hardness of a medical thermoplastic elastomer with the hardness of 60 is selected as a raw material, the diameter of the bottom of the groove is 3mm, the diameters of the prepared liquid stopping device and the hemostatic device are respectively 2cm, 3cm, 4cm, 5cm and 6cm, and the influence of the diameters on the performances of the liquid stopping device and the hemostatic device is analyzed.

When the transmittance of samples with different diameters is observed, the diameter does not directly influence the transparency, but because the internal groove can obstruct the view, the observation of covered characters can be obstructed when the difference between the diameter and the groove aperture is too small.

Stopping the liquid to the device of each diameter respectively, hemostasis effect test, the result is as shown in figure 8, can see that 2cm diameter device appears a large amount of sepage, this is because the diameter is less, when fixing with the sticky tape bending, the center is too near from the edge, lead to unfavorable force application, consequently appear the sepage, 3cm, a small amount of sepage appears in the device of 4cm diameter, can discharge through side drainage tube groove, 5cm, the device of 6cm diameter does not observe obvious sepage, but the device size is too big, oppress too big to the skin during the use, so the device of size 4cm is selected preferably, as shown in figure 9.

After the liquid stopping and hemostatic device is continuously bent for 100 times, the liquid stopping and hemostatic device is not obviously damaged, and a white crease appears in the middle, so that the condition of liquid seepage is not influenced. And (5) performing the liquid stopping and hemostasis effect test again, as shown in fig. 10, a small amount of seepage appears, but the seepage can be discharged through the drainage tube, so that the use is not influenced.

3. Influence of the bottom diameter of the slot:

the medical thermoplastic elastomer with the hardness of 60 is selected as a raw material to prepare the hemostatic device, the diameter of the hemostatic device is 5cm, the diameters of the bottoms of the grooves are 2mm, 3mm, 4mm and 5mm respectively, and the influence of the diameters of the grooves on the performances of the hemostatic device and the hemostatic device is analyzed.

The diameter of the slot has no direct effect on transparency, but the slot can obstruct the view, so the device with the smaller diameter of the slot is more beneficial to observing the covered characters.

Liquid is stopped to the fluting of each diameter respectively, hemostatic effect test, the result is as shown in fig. 11, because the transfer line diameter of chooseing for use is 3.6mm, the fluting of 2mm diameter is difficult to pass through, consequently can't use, 3mm and 4 mm's fluting can let the transfer line pass through easily, also can be better after crooked fastening prevent liquid ooze simultaneously, can only observe trace liquid, and 5mm diameter's fluting is owing to too loose, still appear a large amount of sepages after crooked fastening, can't use. Therefore, the diameter of the notch is preferably selected to be similar to the diameter of the infusion tube, thereby being beneficial to placing the infusion tube and ensuring excellent liquid stopping and hemostasis effects, as shown in figure 12.

After the liquid stopping and hemostatic device was continuously bent 100 times, the appearance was not significantly affected, and the liquid stopping and hemostatic effect test was performed on the bent sample, as shown in fig. 13. The condition of the seepage is not obviously different from that before bending, a small amount of seepage appears, but the seepage can be discharged through the drainage tube, and the use is not influenced.

In summary, the final optimal parameters are medical thermoplastic elastomer with hardness of 60 degrees, device diameter of 4cm and slotting diameter of 3 mm.

Finally, it should be noted that: although the present invention has been described in detail with reference to the foregoing embodiments, it will be apparent to those skilled in the art that changes may be made in the embodiments and/or equivalents thereof without departing from the spirit and scope of the invention as defined in the following claims. Any modification, equivalent replacement, improvement and the like made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.