KR102294242B1 - Instrument for preventing adhesion of uterine cervix with dressing material - Google Patents

Abstract

The present invention relates to a device for preventing cervical adhesions including a dressing material, a hollow drainage tube inserted into the cervix, a support cap connected to one end of the hollow drainage tube and configured to span the cervix, and the other of the hollow drainage tube In the cervical adhesion prevention device connected to the end and spread in the uterus and including at least one fixing leg (Leg) to hold the position of the hollow drainage, a dressing material is laminated on the upper layer of the support cap or on the surface of the support cap As the dressing material is coated, the dressing material is a device for preventing cervical adhesions including a dressing material, characterized in that it consists of a coupling hole coupled to the bottom of the hollow drainage tube, and a main body formed with an upper surface side facing the cervix. make the gist Thereby, the present invention helps the recovery of the affected area after cervical coneectomy to prevent adhesion of the cervix after recovery, and forms a dressing material on the device for preventing adhesions of the cervix to face the cervical tissue, after cervical surgery While preventing the adhesion of the uterus and holding the shape of the cervix, there are advantages of rapid hemostasis, adhesion prevention, and tissue regeneration according to the ingredients of the dressing material.

Description

Cervical adhesion prevention device containing dressing material {Instrument for preventing adhesion of uterine cervix with dressing material}

The present invention relates to an apparatus for preventing adhesions to the cervix including a dressing material, and by forming a dressing material to face the cervix in the apparatus for preventing adhesions to the cervix, preventing adhesion of the uterus after cervical surgery, and holding the shape of the cervix It relates to a device for preventing adhesions to the cervix including a dressing material that supplements functions such as rapid hemostasis, adhesion prevention, and tissue regeneration according to the components of the dressing material while serving.

The female reproductive system is largely composed of ovaries, uterus, and vagina, and the uterus has the highest frequency of diseases. The uterus is in turn composed of the cervix, endometrium, and cervix. More specifically, the entire passage between the uterus and the vagina is referred to as the cervix, and the externally visible portion of the passage between the uterus and the vagina is often referred to as the cervix. Among the detailed structures of the uterus, the cervix has the highest frequency of disease.

The cervix is exposed to diseases such as cervical dysplasia, intraepithelial cancer, and invasive cervical cancer caused by direct viral infection, injury and various stimuli from sexual contact.

If cervical disease is detected by gross or tissue biopsy, cervical cone resection is performed to remove the cervix in a cone shape, and the histological changes occurring in this area are magnified under a microscope to make an accurate diagnosis.

A recovery period of 4 to 6 weeks is usually required after cervical coneectomy. After cervical surgery such as cervical cone resection, continuous bleeding or inflammation occurs, which slows the recovery of the damaged cervix. will cause

In addition, after cervical healing, stenosis and blockage of the cervix may occur, leading to infertility. In addition to infertility, menstrual blood is not discharged smoothly, and menstrual blood accumulates in the uterus, causing periodic abdominal pain and menstrual pain.

As described above, when post-operative complications such as adhesions and blockages of the cervix occur, surgery or procedures for artificially opening the cervical vertebrae or widening the diameter are performed using a sharp instrument.

Even if such an operation for opening and widening is performed, temporary opening cannot be a fundamental solution because it is the cervical adhesion and blockage formed during the regeneration of the first damaged tissue. and blockage symptoms.

Therefore, frequent additional procedures are required, and these additional procedures cause a lot of pain to the patient. There are several problems with the addition.

Conventionally, the degree of hemostasis and disinfection was performed to wait for a natural recovery after cervical cone resection, or to finish and treat the surgical site.

As a solution to this, in Patent Document 1, a cervical tube inserted into the cervix and the cervical tube are integrally formed or connected to block the affected area and consist of a thick cap that induces new skin to be created in the same shape as the original cervix. We introduce recovery tools after cervical surgery.

In Patent Document 2, a hollow drainage tube inserted into the cervix, a support cap configured to be connected to one end of the hollow drainage tube to span the uterine inlet, and the other end of the hollow drainage tube to be spread out in the uterus. Introducing a cervical adhesion prevention device including at least one fixed leg (Leg) to hold the position of the drainage tube.

The prior art provides a device for preventing uterine adhesions after cervical surgery, which is easy and convenient to operate, and which can be stably mounted by fixing the position in the uterus.

However, the prior art simply prevents the adhesion of the uterus physically after cervical surgery and serves to hold the shape of the cervix, but functions such as rapid hemostasis, adhesion prevention, and tissue regeneration are insufficient. it is necessary.

Korean Patent No. 10-1435661. Korean Patent No. 10-1851737.

The present invention is devised by the above necessity, by forming a dressing material to face the cervix in the cervical adhesion prevention device, to prevent adhesion of the uterus after cervical surgery, and to hold the shape of the cervix, while the dressing material An object of the present invention is to provide a device for preventing adhesions to the cervix including a dressing material that supplements functions such as rapid hemostasis, adhesion prevention, and tissue regeneration according to the ingredients.

In order to achieve the above object, the present invention provides a hollow drainage tube inserted into the cervix, a support cap connected to one end of the hollow drainage tube and configured to span the cervix, and the other end of the hollow drainage tube connected to the uterus. In the cervical adhesion prevention device comprising at least one fixed leg (Leg) that unfolds and holds the position of the hollow drainage tube, the dressing material is laminated on the upper layer of the support cap or the dressing material is coated on the surface of the support cap, the The dressing material is a technical gist of the cervical adhesion prevention device including the dressing material, characterized in that it consists of a coupling hole coupled to the bottom of the hollow drainage tube, and a main body formed so that the upper surface side faces the cervix.

In addition, the dressing material, a single material or a mixture of two or more materials is preferably formed in a single layer, or is formed in a multi-layer structure using two or more materials.

In addition, in the dressing material, a heterogeneous material is mixed in the capsule form, or a material of a different type from the outer skin is included in the inner shell, or a different kind from the outer shell is included between the outer skin and the outer skin. ) may be formed as a cover structure in which the material is located.

In addition, the coupling hole of the dressing material is formed in a circular or polygonal shape, or the body of the dressing material is preferably formed in a circular or polygonal shape.

In addition, the dressing material, before absorbing blood or exudate, a vertical cross section is formed in a quadrangle, and after absorption of the blood or exudate, a vertical cross section is formed in a rectangular shape or a polygon in which the upper width is relatively narrower than the lower width it is preferable

In addition, the dressing material is preferably implemented with a natural biocompatible material or a synthetic biocompatible material.

Here, the natural biocompatible material is, chitosan (Chitosan), carboxymethyl chitosan (Carboxymethyl chitosan), chitosan succinate (Succinyl chitosan), cellulose (Cellulose), carboxymethyl cellulose (Carboxymethyl cellulose), regenerated cellulose (or rayon) (Regenerated cellulose or Rayon), hyaluronic acid, sodium alginate, collagen (Collagen), it is preferable to use any one or a mixture of two or more of gelatin (Gelatin).

In addition, the synthetic biocompatible material, kaolin (Kaolin), zeolite (Zeolite), γ- polyglutamic acid (γ-PGA), pullulan (Pullulan), chondroitin sulfate (Chondroitin sulphate), catechol (Catechol), calcium chloride (Calcium chloride), thrombin (Thrombin), fibrinogen (Fibrinogen), it is preferable to use any one or a mixture of two or more of polyurethane foam (PU foam).

In addition, the dressing material may be formed by pouring a solution containing the material of the dressing material into a mold, freeze-drying, and then pressing.

In addition, the dressing material may be subjected to chemical treatment or heat treatment using an acidic solution, or absorption power may be improved through crosslinking through UV, and the dressing material may be further subjected to a surfactant treatment to improve the absorption rate.

An object of the present invention is to provide a device capable of preventing adhesions of the cervix after recovery by helping the recovery of the affected area after cervical cone resection.

In addition, the present invention forms a dressing material in the cervical adhesion prevention device to face the cervical tissue, prevents adhesion of the uterus after cervical surgery, and serves to hold the shape of the cervix, according to the ingredients of the dressing material It has the effect of rapid hemostasis, prevention of adhesions, and tissue regeneration.

Therefore, it is possible to prevent the slow recovery of the affected area by infection or foreign substances, and to help the rapid recovery because rapid tissue regeneration is achieved.

1 - A schematic diagram of a device for preventing adhesions to the cervix according to an embodiment of the present invention.
Figure 2 - A schematic diagram showing a structure for a dressing material according to various embodiments of the present invention.
Figure 3 - A schematic diagram showing an upper side structure for a dressing material according to various embodiments of the present invention.
Figure 4 - A schematic diagram showing the structure of the coupling hole of the dressing material according to various embodiments of the present invention.
Figure 5 - A schematic vertical cross-sectional view before (a) and after (b) absorption of blood or exudate of the dressing material according to various embodiments of the present invention.
6 - A perspective view of a dressing material according to an embodiment of the present invention.
7 - A perspective view of a device for preventing adhesions to the cervix including a dressing material according to an embodiment of the present invention.
Figure 8 - A perspective view of a device for preventing cervical adhesions including a dressing material according to another embodiment of the present invention.
Figure 9 - A graph showing the blood coagulation index of the dressing material according to an embodiment of the present invention.
Figure 10 - A schematic diagram of the use state of the cervical adhesion prevention device containing the dressing material according to an embodiment of the present invention applied to the cervix.

The present invention is a device for preventing cervical adhesions, by forming a dressing material to face the cervix, preventing adhesion of the uterus after cervical surgery, and holding the shape of the cervix, while rapidly hemostasis according to the components of the dressing material It relates to an anti-adhesion device on the cervix containing a dressing material that complements functions such as , adhesion prevention and tissue regeneration.

Hereinafter, the present invention will be described in detail with reference to the accompanying drawings. Figure 1 is a schematic diagram of a device for preventing adhesions to the cervix according to an embodiment of the present invention, Figure 2 is a schematic diagram showing the structure of a dressing material according to various embodiments of the present invention, Figure 3 is various implementations of the present invention It is a schematic diagram showing the upper side structure of the dressing material according to the example, Figure 4 is a schematic diagram showing the coupling hole structure of the dressing material according to various embodiments of the present invention, Figure 5 is the blood of the dressing material according to various embodiments of the present invention Or before absorbing exudate (a) and after absorbing (b) shows a vertical cross-sectional schematic diagram, Figure 6 is a perspective view of a dressing material according to an embodiment of the present invention, Figure 7 is an embodiment of the present invention A perspective view of an apparatus for preventing adhesions to the cervix including a dressing material according to an example, FIG. 8 is a perspective view of an apparatus for preventing adhesions to the cervix including a dressing material according to another embodiment of the present invention, and FIG. It is a graph showing the blood coagulation index of the dressing material according to the example, and FIG. 10 is a schematic diagram showing the use state in which the cervical adhesion prevention device including the dressing material according to an embodiment of the present invention is applied to the cervical region.

As shown, the device for preventing cervical adhesions including the dressing material according to the present invention is a hollow drainage tube 100 inserted into the cervix, connected to one end of the hollow drainage tube 100 so as to span the cervix. The configured support cap 200 and at least one fixed leg (Leg) 300 connected to the other end of the hollow drain tube 100 and spread in the uterus to hold the position of the hollow drain tube 100 In the cervical adhesion prevention device, the dressing material 400 is laminated on the upper layer of the support cap 200 or the dressing material 400 is coated on the surface of the support cap 200, the dressing material 400 is, It characterized in that it consists of a coupling hole 410 coupled to the bottom of the hollow drainage tube 100, and a body 420 formed so that the upper surface side faces the cervix.

Since the device for preventing cervical adhesions is maintained during the recovery period in a state of being inserted into the body, it is preferable to be made of a material harmless to the human body. However, the present invention is not limited thereto.

For example, the hollow drain tube 100 and the support cap 200 are integrally molded with a silicone material, or the hollow drain tube 100 is made of a silicone material and the support cap 200 is made of a suture material. It will be possible to implement in a variety of forms, such as a form in which they are configured and connected to each other, or a hollow drain pipe 100 and the support cap 200 are all made of a suture material.

In the case of the suture material, it is used to suture the incision site in general medical surgery or procedure, and the suture is removed after the treatment of the affected area, but an absorbable material, for example, polylactic acid (Polylactic Acid), polydiasonone, a copolymer of lactic acid and glycolic acid, etc., may be used so that it can be absorbed into the body without removing it after the procedure.

As shown in FIG. 1 , the hollow drainage tube 100 is inserted into the cervix, and a space is formed therein, and may be a hollow type having a passage through which secretions generated from the uterus can be discharged to the outside. In addition, the hollow drainage tube 100 may be provided with at least one drainage port 110 for drainage of the secretions on the side.

And the support cap 200 may be configured to be connected to one end of the hollow drainage tube 100 and span the uterine inlet (cervix). At this time, it is preferable to connect the hollow drain pipe 100 as a central axis. That is, the central portion of the support cap 200 and one end of the hollow drain pipe 100 are connected.

The support cap 200 is provided with at least one drainage port 210 on the surface, so that foreign substances such as inflammatory substances generated when the affected part is recovered can be smoothly discharged to the outside to help the recovery.

Even in the case of the drain hole 210 of the support cap 200, when the support cap 200 is made of a silicone material, one or a plurality of drain holes may be formed integrally during the molding process, and the When configured, the support cap 200 may be configured (weaved) in a mesh type to naturally form one or a plurality of drainage holes.

The support cap 200 has a shape extending to a predetermined length in all directions about the hollow drain pipe 100 as a central axis, and may have a circular, polygonal, star-shaped or radial shape, but is not limited thereto.

In addition, since the support cap 200 may have any shape as long as the overall cross-section is a gentle mountain shape or a shape close to the patient's original uterus, such as a square shape or an oval shape, the shape is not limited to any one. Preferably, the support cap 200 is inclined so that the thickness becomes smaller as it goes away from the hollow drain pipe 100 so that the drainage can proceed smoothly.

In addition, the support cap 200 may form a protrusion or concavo-convex on the upper surface to prevent close contact with the cervix.

In addition, the fixing leg 300 is connected to the other end of the hollow drainage tube 100 and spreads in the uterus to hold the position of the hollow drainage tube 100 , and may consist of at least one or more. Accordingly, the fixing leg 300 is preferably made of a flexible material.

The fixing leg 300 is formed to extend long in a plurality of directions from the hollow drainage tube 100, and includes a wing portion that is formed to extend in the left and right directions in the middle portion, the area that can be fixed in the uterus can be obtained more widely. In addition, a fixing protrusion 310 is formed at the distal end of the fixing leg 300 so that it is well fixed in the uterus.

Here, an insertion hole 120 is formed at a position where the outer diameter of one end of the hollow drain pipe 100 and the support cap 200 are connected, and a supporting appearance (not shown) along the outer diameter of the hollow drain pipe 100 time) to be inserted, and the fixed leg 300 moves up and down along the hollow drain pipe 100 to unfold the fixed leg 300 (when the support exterior is removed), or to be wrapped in the support exterior. to be inserted through the cervix.

And the dressing material 400 is laminated on the upper layer of the support cap 200 , or the dressing material 400 is coated on the surface of the support cap 200 . The support cap 200 is configured to span the cervix, and the dressing material 400 is formed between the surface of the cervix and the support cap 200 to absorb blood or exudates emitted from the affected area after surgery, It serves to assist in the rapid regeneration of the affected tissue.

Accordingly, the dressing material 400 is basically formed of a material with excellent biocompatibility, and may include a functional ingredient having a function of preventing adhesion of cervical tissue and tissue regeneration while performing a hemostatic action.

The dressing material 400 may be made of only a fiber-based nonwoven fabric for hemostasis, and may be made of only a chitosan-based nonwoven fabric in order to utilize the useful function of chitosan. In this case, when only chitosan is applied, the material becomes soft as it gels, making it difficult to maintain strength and shape. have.

In addition, the dressing material 400 may be provided in the form of a non-woven fabric in which a hemostatic material is mixed, or a non-woven fabric in which a coating layer made of a hemostatic material is formed on the surface of a single layer or a plurality of layers.

In addition, the dressing material 400 may be implemented with a natural biocompatible material or a synthetic biocompatible material, and the above-described cellulose (cotton, silk or hemp), regenerated cellulose (rayon) to support the material alone or the material. Or human), alginate and casein may be mixed and used.

Specifically, the natural biocompatible material is chitosan (Chitosan), carboxymethyl chitosan (Carboxymethyl chitosan), chitosan succinate (Succinyl chitosan), cellulose (Cellulose), carboxymethyl cellulose (Carboxymethyl cellulose), regenerated cellulose (or rayon) ( Regenerated cellulose or Rayon), hyaluronic acid, sodium alginate, collagen, gelatin, any one or a mixture of two or more is used.

In addition, the synthetic biocompatible material is kaolin (Kaolin), zeolite (Zeolite), γ- polyglutamic acid (γ-PGA), pullulan (Pullulan), chondroitin sulfate (Chondroitin sulphate), catechol (Catechol), calcium chloride ( Calcium chloride), thrombin (Thrombin), fibrinogen (Fibrinogen), any one of polyurethane foam (PU foam) or a mixture of two or more can be used.

The dressing material 400 according to the present invention is formed on the support cap 200, and the coupling hole 410 coupled to the bottom of the hollow drain tube 100 and the upper surface side are formed to face the cervix. It is characterized in that it consists of (420).

The dressing material 400 is coupled to the support cap 200 with the hollow drain pipe 100 in the center, and a coupling hole 410 for coupling with the hollow drain pipe 100 is formed in the center. should be The coupling hole 410 may be formed in a size large enough to accommodate the hollow drain pipe 100, and the shape may be circular or polygonal as shown in FIG. 4 .

In addition, as shown in FIG. 3 , the main body 420 of the dressing material 400 is formed in a circular or polygonal shape around the coupling hole 410 , and is located on the support cap 200 to reduce the cervix. It is formed to have a size and shape similar to that of the support cap 200 to face.

The shape of the dressing material 400 is formed by deforming according to the application environment of the affected part.

5 is a vertical cross-sectional schematic diagram before absorbing blood or exudate of the dressing material 400 according to various embodiments of the present invention (a) and after absorbing (b) a vertical cross-sectional schematic diagram, based on the form after absorption After molding and preparing the dressing 400 through freeze-drying, it is provided by pressing in the form before absorption.

Here, after the dressing material 400 absorbs blood or exudate, it is characterized in that the vertical cross section is formed in a rectangular shape or a polygonal shape having a relatively narrow upper width than the lower width. This is to make it better to conduct a hemovascularization in the affected part of the same shape as the cervix.

That is, the dressing material 400 according to the present invention is manufactured by a mold based on the shape after absorption, and is provided after being freeze-dried. The upper portion of the provided dressing material 400 is compressed to form a pre-absorption shape as shown in FIG. That is, it returns to the initial form that was lyophilized before being compressed.

6 shows a dressing material 400 having a circular coupling hole 410 and a circular body in an embodiment of the present invention, and the hollow drain pipe 100 is coupled to the coupling hole 410 and the body is It is seated on the support cam.

As shown in Figure 7 (a), in one embodiment, the diameter of the dressing material 400 is 20 ~ 26mm, the diameter of the coupling hole 410 is 3 ~ 6mm, the height is 1 ~ 5mm before absorption, absorption In the case of the latter, it will be provided in 10-35mm. It can be formed by adjusting the size of the affected area and the hemovascularization site.

Figure 7 (b) is to form a cutout 430 in a part of the dressing material 400 in order to physically couple the dressing material 400 to the cervical adhesion prevention device according to another embodiment of the present invention, It is fitted to the hollow drain pipe 100 so that the coupling hole 410 of the hollow drain pipe 100 and the dressing material 400 is coupled.

In this case, the dressing material 400 is formed to a predetermined thickness by pouring a solution containing the material of the dressing material 400 into a mold, freezing, freeze-drying, and then compressing it. The solution is prepared by dissolving 1-5% of the dressing material 400 in distilled water, then adding 1-5% glycerin and stirring for 2 hours or more.

The freeze-drying is to evaporate the moisture by putting the blood frame into a freeze dryer and then freeze-drying after rapid cooling, and drying is performed while raising the temperature from -40°C to 30°C in a vacuum. Thereafter, the dressing material 400 is provided by compression to a desired thickness.

Here, the dressing material 400 may be subjected to chemical treatment or heat treatment using an acidic solution, to improve absorption through cross-linking through UV, or to further increase the absorption rate by performing a surfactant treatment.

Specifically, chemical treatment or heat treatment using an acidic solution (acetic acid, hydrochloric acid, ascorbic acid, glutamic acid, citric acid, formic acid, etc.) and glycerin, acetaldehyde, glutaraldehyde, formaldehyde to enhance the absorbency of the dressing material 400 , polyethylene glycol diacrylate, crosslinking through UV can be used.

In addition, surfactant treatment such as tween 20, tween 60, or tween 80 may be applied to enhance the absorption rate.

Of course, the dressing material 400 may be lyophilized and compressed as described above, physically coupled to the hollow drain pipe 100 and laminated on the upper layer of the support cap 200 , and the surface of the support cap 200 . The dressing material 400 may be coated and formed. That is, the support cap 200 may be impregnated in a solution containing the dressing material 400 , or the dressing material 400 may be implemented on the cervical adhesion prevention device by a method such as electrospinning.

Figure 8 is formed by coating the dressing material 400 on the surface of the support cap 200, and is formed by impregnating the support cap 200 in a solution containing the dressing material 400, the dressing material 400 The support cap 200 is positioned therein.

As described above, the dressing material 400 is included in the device for preventing cervical adhesions to facilitate management of bleeding and exudates from the affected area after coneectomy, which is a cervical surgery. to give more functions.

On the other hand, the dressing material 400 used in the present invention is formed as a single layer by mixing a single material (FIG. 2(a) or two or more materials (FIG. 2(d)) on the support cap 200, or 2 It can be formed in a multi-layer structure (FIG. 2(b)) using more than one type of material.

In addition, in the dressing material 400, different materials are mixed in the form of a capsule (Fig. 2(e)) A cover structure may be formed.

In addition, the dressing material 400 may be formed in a sandwich structure (FIG. 2(f)) in which a different material is formed between the outer skin and the outer skin.

When the dressing material 400 has a structure formed in the single layer, as described above, a solution containing the material of the dressing material 400 is poured into a mold, and then freeze-dried to form it. And in the case of the multi-layer structure and the sandwich structure, after freezing the first layer, the solution corresponding to the next layer is poured and frozen, and after repeating this process, freeze-drying is performed.

When the dressing material 400 contains capsules, the capsules are mixed with the solution and dispersed, then the solution is frozen and freeze-dried to form. to form

As described above, after freeze-drying, it is compressed to an appropriate size and punched using a mold suitable for the product shape to provide a dressing material.

Hereinafter, data according to the test for absorbency and hemostatic properties of the dressing material according to an embodiment of the present invention will be described.

① Absorption test

- Test standard: EN13726-1: Test methods for primary wound dressings. Aspects of absorbency

- Scope of application: Absorbent products. Applied to products used for a short period of time in the form of attachment for the purpose of absorption of exudates

- Purpose of the test: This is a test standard to measure the absorption of exudate and body fluids on the wound surface.

- Test Methods:

⑴ Prepare a sample (eg, cut into (5 × 5) cm size) considering the usage method and purpose of the product, place it in a Petri dish, and measure the weight (W1).

(2) Accurately measure up to ± 0.5 g of distilled water pre-warmed to (37 ± 1) °C, and add it in consideration of the absorbency of the product (eg, add 40 times the weight of the sample).

⑶ (37 ± 1) ℃ After standing for 30 minutes in a thermostat, use tweezers to hang the sample for 30 seconds, and then measure the weight (W2).

⑷ Measure the absorption power using the formula below.

The following Table 1 is a test result of testing the absorption power according to each Example.

W1 W2 absorptivity Example One 0.1 3.485 33.85 Example 2 0.097 3.406 34.11 Example 3 0.109 3.897 34.75 average 34.24

Table 2 below is the data of the absorbency test of other companies' products.

Specimen name (2 X 2 cm) W1 W2 absorptivity plain gauze 0.024 0.261 9.875 0.024 0.261 9.875 0.024 0.311 11.958 average 10.569 STANPAD 0.013 0.127 8.769 0.013 0.161 11.385 0.013 0.162 11.462 average 10.539 GuardaCare 0.019 0.146 6.684 0.020 0.161 7.050 0.022 0.161 6.318 average 6.684 QuikClot 0.027 0.279 9.333 0.027 0.298 10.037 0.027 0.301 10.148 average 9.839

It was confirmed that the embodiment (dressing material) according to the present invention has significantly superior absorption power compared to the existing products of other companies.

② Hemostatic test

- Test standard: own standard

- Test purpose: to evaluate the blood clotting ability of the dressing

- Test Methods:

⑴ Cut the sample into 2 x 2 cm, and put it in a 50 ml tube.

₍₂₎ Prepare a mixture of blood collected from rabbits, ACD, and CaCl 2 .

(Blood:ACD:1M CaCl2 = 0.270ml:0.030ml:0.024ml)

Here, ACD is a mixture of citric acid, sodium citrate, and glucose, and is an abbreviation of Acid citrate dextrose solution. It is added for the purpose of preventing coagulation for the storage of the collected blood.

And, CaCl ₂ is administered to prevent the anticoagulant role of blood anticoagulated with ACD.

⑶ In the tube containing each sample, 100ul of the blood prepared in step (2) is treated on the sample, and then reacted at room temperature for 0, 15, 30, 60, and 90 seconds at each time zone.

⑷ Carefully add 10 ml of physiological saline through the inner wall of the tube to the sample reacted for each time period.

⑸ Centrifuge at 100G for 30 seconds.

⑹ Carefully transfer only the supernatant (except the sample and blood) to a new tube, and then add ultrapure distilled water so that the volume becomes 50 ml.

⑺ After reacting at room temperature for 30 minutes, 200 μl of sample is injected into each well of a 96-well transparent plate, and absorbance is measured at 540 nm using an ELISA spectrometer.

Figure 9 is a graph showing the blood coagulation index of the dressing material according to an embodiment of the present invention, BCI: Blood coagulation index shows the blood coagulation index.

This is because as the amount of uncoagulated blood increases, the dispersion of blood in distilled water increases, so the color of the solution becomes reddish and the absorbance at a specific wavelength increases. At this time, the higher the absorbance, the higher the BCI value.

As shown in FIG. 9, the BCI of the dressing material according to the embodiment of the present invention was much lower than that of the general dressing material, and it was confirmed that the embodiment of the present invention had significantly superior hemostatic performance.

OD _b : absorbance in pure distilled water

OD _t : Absorbance of blood released from the sample

10 is a schematic diagram showing a state in which the cervical adhesion prevention device including the dressing material according to an embodiment of the present invention is applied to the cervix, and the cervical adhesion prevention device including the dressing material in the cervix 10 is is inserted, the support cap 200 is spread over the cervix 20, and the fixing leg 300 is spread inside the uterus to hold the position.

As described above, according to the present invention, the device for preventing cervical adhesions of the present invention, which is inserted through the cervix and operated after the cervical cone resection is completed, can prevent the cervix from stenosis or adhesion. Basically, the secretions produced in the uterus can be discharged through the drainage tube and the drainage hole formed on the side of the drainage tube, and foreign substances generated in the process of recovering the affected part are discharged to the outside through one or more drainage holes formed in the support cap. can

And, the dressing material formed on the support cap prevents adhesion of the uterus after cervical surgery, and serves to hold the shape of the cervix, and functions such as rapid hemostasis, adhesion prevention, and tissue regeneration according to the components of the dressing material. .

Therefore, it is possible to prevent the slow recovery of the affected area by infection or foreign substances, and to help the rapid recovery because rapid tissue regeneration is achieved.

10: cervix 20: cervix
100: drain pipe 110: drain port
200: support cap 210: drain port
300: fixing leg 310: fixing protrusion
400: dressing material 410: coupling hole
420: body

Claims (14)

A hollow drainage tube inserted into the cervix, a support cap connected to one end of the hollow drainage tube and configured to span the cervix, and the other end of the hollow drainage tube extended in the uterus to hold the position of the hollow drainage tube In the cervical adhesion prevention device comprising at least one fixed leg (Leg),
At least a portion around one end of the hollow drain pipe on the upper surface of the support cap has a flat shape,
A dressing material for absorbing blood or exudate is laminated on the upper layer of the support cap or a dressing material is coated on the surface of the support cap,
The dressing material,
At least a portion around one end of the hollow drain pipe on the upper surface of the support cap has a flat shape,
a coupling hole coupled to the bottom of the hollow drain pipe; and
Consists of; a body formed so that the upper surface side faces the cervix,
The dressing material,
It is formed by pouring a solution containing the material of the dressing material into the mold, freeze-drying it, and then compressing it.
After absorption of the blood or exudate, the thickness becomes thicker than before absorption, and the vertical section is formed in a polygonal shape having a relatively narrow upper width than the lower width, and the thickness of the central portion of the cervix is thicker than the thickness of the peripheral portion Cervical adhesion prevention device containing a dressing material, characterized in that. According to claim 1, The dressing material,
A single material or two or more materials are mixed to form a single layer,
Cervical adhesion prevention device with dressing material, characterized in that it is formed in a multi-layer structure using two or more materials. According to claim 1, The dressing material,
A device for preventing adhesions to the cervix with a dressing material, characterized in that heterogeneous materials are mixed inside in the form of a capsule. According to claim 1, The dressing material,
A device for preventing adhesions to the cervix with a dressing material, characterized in that it contains a material of a different species from the outer skin inside the outer skin. According to claim 1, The dressing material,
A device for preventing adhesions to the cervix with a dressing material, characterized in that a material of a different species is positioned between the shell and the shell. According to claim 1, wherein the coupling hole of the dressing material,
Cervical adhesion prevention device with dressing material, characterized in that formed in a circular or polygonal shape. According to claim 1, wherein the body of the dressing material,
Cervical adhesion prevention device with dressing material, characterized in that formed in a circular or polygonal shape. delete According to claim 1, The dressing material,
A device for preventing cervical adhesions with a dressing material, characterized in that it is implemented with a natural biocompatible material or a synthetic biocompatible material. 10. The method of claim 9, wherein the natural biocompatible material,
Chitosan, carboxymethyl chitosan, chitosan succinate (Succinyl chitosan), cellulose (Cellulose), carboxymethyl cellulose (Carboxymethyl cellulose), regenerated cellulose (or Rayon), hyaluronic acid ( Hyaluronic acid), sodium alginate (Sodium alginate), collagen (Collagen), gelatin (Gelatin) any one or a combination of two or more of the dressing material containing a cervical adhesion prevention device, characterized in that used. 10. The method of claim 9, wherein the synthetic biocompatible material,
Kaolin, Zeolite, γ-Polyglutamic Acid (γ-PGA), Pullulan, Chondroitin sulphate, Catechol, Calcium chloride, Thrombin , Fibrinogen, polyurethane foam (PU foam), characterized in that any one or a mixture of two or more of the dressing material containing a cervical adhesion prevention device. delete According to claim 1, The dressing material,
chemical treatment or heat treatment using an acidic solution; or
Cervical adhesion prevention device with dressing material, characterized in that the absorption is improved through crosslinking through UV. According to claim 13, The dressing material,
Cervical adhesion prevention device containing a dressing material, characterized in that the surface active treatment is further performed.

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