KR20050118060A - Injectable filler made by acellular dermis - Google Patents

Abstract

The present invention relates to a filler processed into a cell-free dermis in an injectable form, and in particular, to a filler having a particle width of 1 mm to 2.3 mm and a length of 4 mm to 5.5 mm and processed in streamline.

The streamlined filler particles can easily pass through the needle to reduce the injection pressure during injection to increase the accuracy of the procedure.The width of the filler particles in the range of 1 mm to 2.3 mm allows the filler particles to be injected 16 or 18 gauge one by one. By passing the needle to uniformly expand the volume, as well as to improve the efficiency of the volume expansion, the length is included in the range of 4 mm to 5.5 mm has an effect that can naturally respond to the movement of the facial muscles.

Description

Filler processed cell-free dermis into injectable form {INJECTABLE FILLER MADE BY ACELLULAR DERMIS}

The present invention relates to a filler used for wrinkle removal and facial contour correction using acellular dermis, and more particularly, to the shape of a filler. Fillers are implants used to improve wrinkles or to reconstruct facial contours by inserting them into specific areas to expand soft tissue, and generally use biological tissue or chemicals.

Fillers made of chemicals such as atechol do not cause allergic reactions by foreign proteins in the human body and can be used as permanent fillers because they are not absorbed by the human body over time, but they are not easy to remove once injected. Care must be taken, and the wrong injection is difficult to recover.

On the other hand, the filler composed of the patient's own biological tissues, such as autologous fat, collagen is a biological tissue separated from the patient's human body does not cause an allergic reaction after injection. However, in order to use this method, there is a disadvantage that a separate process of extracting a living tissue before the procedure is inevitable.

Therefore, in recent years, cell-free dermal fillers, such as alloderm and shurederm, which have been immunized with the dermis separated from the carcass, have been developed and utilized in the field of plastic surgery.

Acellular dermis is a substance made by removing the epidermal layer and immune cells from the skin of a dead person. Since it is composed of tissues and fibers that are not immune, there are no side effects such as immune rejection or infection.

It was developed in the United States for the treatment of burns in 1991, but it has been widely used for the purpose of removing wrinkles, rhinoplasty, and scar removal. When the acellular dermis is implanted into the skin, new cells are inserted into it. As it grows in, new blood vessels form and have the same function as the skin next to it.

Since the cell-free dermis is absorbed into the body after a certain period of time after skin transplantation, there is no difficulty in elimination, which is a disadvantage of the chemical filler, but it is absorbed into the body as time passes and the procedure must be performed again when the volume sense disappears. This remains.

The procedure for inserting acellular dermis into wrinkles or soft tissues to be expanded is largely classified into two types. One is to cut the skin through a surgical operation and insert the cell-free dermis in the form of a stripe into the incision. The other is to process and inject the cell-free dermis into a powder form.

Surgical procedures have the disadvantages of a large surgical incision because of the wide incision site, and a long recovery time such as treatment of edema occurring after surgery. In addition, the cell-shaped dermis in the form of a strip embedded in the skin has a disadvantage in that the movement is not natural in appearance because it moves as a plate as a separate tissue from the patient's skin until engraftment on the skin of the patient.

The injection method using a syringe injects the cell-free dermis powdered into a diameter of about 850 µm with the liquid to the treatment site. This procedure has the advantage that the procedure is simple and quick to recover because it does not cut the skin, but the problem is that the duration is very short, about 10 weeks.

In other words, by processing the cell-free dermis into fine grains, the injection becomes possible and the procedure is easy, but the finer the particles, the shorter the period of absorption into the body. The short duration problem not only creates the hassle of having to repeat the procedure for a short period of time in order to maintain the effectiveness of the procedure, but also makes it difficult to use the procedure due to the high cost of using the cell-free dermis. have.

As described above, the filler has various problems such as allergic reaction by foreign protein, simplicity of procedure and persistence of effect, and especially in wrinkle removal using acellular dermis, the simplicity of procedure and the persistence of procedure effect It has been known to be incompatible conditions.

Recognizing this problem, as shown in FIG. 1, aloderm, which is a kind of cell-free dermis, has been processed into 2mm × 2mm particles, and then injected using 16 or 18 gauge injection, thereby eliminating the cell-free dermis in stripe form. It has been reported in the academic community that the effect of the procedure can last for many years, similar to the insertion of the. In other words, by simply using a syringe and at the same time increasing the particle size of the filler to extend the duration, a new electricity has been prepared in the field of the procedure using acellular dermis.

For reference, the reason for using a 16 or 18 gauge needle during the procedure is as follows. In general, the facial skin thickness is about 1 mm, so when using a thicker needle to inject acellular dermis into the subcutaneous layer, the acellular dermal layer to be injected is formed relatively thicker than the skin, resulting in a smooth facial surface after the procedure. It can be rugged. On the other hand, when the procedure using a needle that is thinner than 16 or 18 gauge, there is a problem that the efficiency of volume expansion is inferior. For this reason, it is preferable to use 16 or 18 gauge needles when injecting filler into the facial area.

However, when the filler particles are processed into a square shape ( 2 mm × 2 mm ) and injected, it is not easy to pass the 16 or 18 gauge needle, so the injection pressure is high. If the injection pressure is high, it is difficult to precisely control the injection amount of the filler, and as a result, it becomes a factor that makes the procedure difficult.

In addition, when the length of the filler is short, such as about 2 mm, it was confirmed that the efficiency of the volume expansion is inferior.

Accordingly, an object of the present invention is to provide a filler having a shape that allows an injection pressure to a degree capable of precisely controlling the injection amount by improving the above-described problem.

In addition, an object of the present invention is to enable the filler particles to pass through a 16 gauge or 18 gauge needle one by one, thereby allowing the volume to be uniformly expanded.

It is also an object of the present invention to provide a filler having a shape that improves the efficiency of volume expansion due to filler injection.

Another object of the present invention is to provide a filler in which the surface, the back, and the sides of the cell-free dermis are evenly mixed when the filler is made of the cell-free dermis.

In addition, an object of the present invention is to provide a filler having a shape such that the facial movement becomes natural in appearance after injecting the filler to engraftment.

It is also an object of the present invention to provide a filler in which the filler is mixed with the fibrin and injected to further delay the absorption of the filler into the living body, thereby increasing the duration.

In order to achieve the above object, the present invention provides a streamlined filler having a width in the range of 1 mm to 2.3 mm and a length in the range of 4 mm to 5.5 mm. 2 to 4 illustrate an embodiment of a filler processed into a shredder or alloder, which is a kind of acellular dermis, in the above-described shape, and FIG. 5 illustrates a procedure of using the filler shown in FIG. 2. 6 is a view illustrating the extent of volume expansion according to the width of the filler when the filler is injected into the subcutaneous fat layer, and FIG. 7 shows a state in which the filler particles are uniformly arranged upwards. 8 shows a state in which the surface, the back side, and the side surfaces of the filler particles are evenly arranged. Hereinafter, the present invention will be described in detail with reference to FIGS. 2 to 8.

Cell-free dermis, as mentioned above, removes the epidermal layer and immune cells from the skin isolated from the corpse, which is somewhat different depending on the site, but is generally about 1 mm thick, 2 cm x 7 cm or 3 cm Size products, such as x 7 cm , are commercially available. In Fig. 2, for example, a shroud of 2 cm by 7 cm is shown, and a filler patterned by streamlined particles having a width of 1 mm to 2.3 mm and a length of 4 mm to 5.5 mm, in particular rice seed-shaped particles, is characterized as a characteristic configuration. I'm proposing. On the other hand, Figure 3 is proposed as a characteristic configuration of a filler patterned in an elongated hexagonal shape as a streamlined particle of the size, Figure 4 is a streamlined particle of the size is added to the pattern of the rod-shaped pieces going to one side as an elongated octagonal A filler is proposed in a characteristic configuration.

Generally, the patterned filler is injected into the subcutaneous fat layer through a syringe after a period of hydration treatment. In this case, the longer the hydration treatment time, the more the filler particles recede, so that the injection pressure during injection becomes low. Therefore, while it is easy to control the injection amount of the filler during the procedure, there is a disadvantage that the volume in the human body decreases as much as withdrawal.

Applicants set the hydration time to 20 minutes in consideration of the degree of volume expansion after the procedure and experimented with fillers patterned into various shapes. As a result, it was confirmed that the filler of the above-mentioned shape exerts an excellent effect in wrinkle treatment or facial contour correction.

First, the relationship between the width of the filler and the injection pressure during the filler injection is as follows. By subdividing the movement of the filler through the syringe, it can be divided into the stage where the filler just enters the syringe opening and the stage passes through the syringe. The injection pressure at the stage where the filler just enters the syringe opening is higher than the injection pressure at the stage where the filler flows through the syringe. Therefore, when the filler is injected into the syringe, the pressure felt in the hand is not constant, and as the filler is injected into the needle one by one, clogging and passing are felt repeatedly.

By the way, when the width of the filler is 2.3 mm or more, the pressure passing through the 16 gauge injection needle becomes 1.0 kgf / cm 2 or more, and at this time, the pressure difference between the blockage and the passage felt by the hand becomes very large. Therefore, it is impossible to uniformly control the injection amount of the filler. In other words, the injection amount of the filler cannot be uniformly controlled because the pressure applied to the hand cannot be appropriately attenuated when the transition from the clogging step to the passage step is performed.

However, when the width of the filler is 2.3 mm or less, since the pressure difference in the blockage and passage stage is not large, relatively uniform control is possible. Therefore, it is preferable that the width of a filler becomes 2.3 mm or less.

On the other hand, a filler width of 2.3 mm or less does not necessarily mean 1.0 kgf / cm 2 or less. The injection pressure may vary depending on the shape of the filler particles. For example, even if the width is 2 mm, if the shape of the filler is rectangular, the injection pressure exceeds 2.0 kgf / cm 2 and is not suitable for the procedure. For this reason, the present invention proposes to process the filler particles in a streamlined fashion. Applicant was able to increase the accuracy of the procedure by significantly lowering the injection pressure by processing the filler in a streamlined injection.

Here, the streamline refers to a thin shape of the head and tail of the filler particles and a thick body. The head and tail are thinned to facilitate passage of the needle, and the body is thickened to effectively expand the volume of the soft tissue. This will be described later in detail.

In particular, by patterning the filler in the shape of a rice seed as shown in FIG. 2, it is possible to minimize the loss when patterning the cell free dermis. Minimizing the loss in the procedure using expensive cell-free dermis means that the volume can be expanded even more at the same cost, thereby reducing the cost of the procedure.

Next, the relationship between the width | variety and the volume expandability of a filler particle is demonstrated with reference to FIG. 5 and FIG. The filler is injected into the subcutaneous fat layer through a 16 gauge needle, as shown in FIG. 5. First, the needle is inserted into the subcutaneous fat layer to form a filler injection space, and then the needle is retracted while injecting the filler by applying pressure to the syringe.

Although there is a difference depending on the treatment site, a filler injection space is generally formed at intervals of about 7 mm at the treatment site. For example, three lines are formed as injection spaces in FIG. 3. When forming the injection space, it is not necessary to insert a needle into each line. Insert the injection needle in a spaced distance from the treatment site and adjust the angle of the needle while considering the skin elasticity to form a filler injection space by inserting the injection needle in each line. Therefore, only 1 needle mark appeared on the outside.

At this time, since the diameter of the 16 gauge needle is 1.295 mm (16 gauge), the filler injection space formed by the needle becomes about 1.295 mm in diameter. Therefore, the filler particles having a larger width are bulged in a direction perpendicular to the skin by the pressing force from both sides of the injection space as shown in FIG. 4. By bulging in this way, the volume of the facial skin is expanded in the vertical direction. (The thickness of the filler particles is limited to 1 mm as described above.)

Therefore, the larger the width of the filler particles, the greater the effect of volume expansion. However, since the thickness of the facial skin is about 1 mm, injecting an excessively large filler may result in aesthetically undesirable results such as uneven surface. Accordingly, the present invention proposes a width of the filler to prevent the surface from becoming excessively uneven in consideration of the facial skin thickness, and the value thereof is 2.3 mm or less.

On the other hand, when the width of the filler particles is 1 mm or less, the width of the filler particles and the diameter of the injection space of the subcutaneous fat layer into which the filler particles are injected are not significantly different. Therefore, the force of the filler particles injected into the subcutaneous fat layer from the side of the injection space is small, and as a result, the degree of swelling in the direction perpendicular to the skin is small. Therefore, it is difficult to expect the effect of filler injection.

In addition, when the width of the filler particles is 1 mm or less, there is a risk that two filler particles are caught at once in a 16 gauge or 18 gauge needle, and in this case, the filler particles cannot pass through the needle, making the procedure impossible. For this reason, the width of the filler particles is preferably included in the range of 1 mm to 2.3 mm.

Next, the relationship between the width of the filler particles and the arrangement of the filler particles will be described with reference to FIGS. 7 and 8. In filler injection, the filler particles are arranged partially out of the injection needle one by one. On the other hand, the cell-free dermis shows a minute difference in the process of engraftment in the human body according to its surface, back and side.

In view of such a difference in engraftment process, as shown in FIG. 7, the filler particles are arranged with the surface of the cell free dermis aligned all up so that the surface of the cell free dermis can contact skin cells. It is good.

However, such control during filler injection is impossible, and as shown in FIG. 8, it is suboptimal to randomly mix the surfaces, the back, and the sides of the cell-free dermis into contact with the skin.

However, when the width of the filler particles is larger than 2.3 mm, the possibility that the side surfaces of the filler particles come into contact with the skin is very low. This is closely related to the thickness of the filler particles of about 1 mm. Since the thickness of the filler particles is about 1 mm and thinner than the width, when the width of the particles is larger than 2.3 mm, the filler particles are difficult to stand laterally and are inclined. As a result, the filler particles collapse and the surface or back face contacts the skin. That is, the possibility that the side surface of a filler particle comes in contact with skin becomes low.

Therefore, the surface, back and sides of the filler particles may not evenly contact the skin, which lowers the engraftment rate of the filler. Therefore, the width of the filler particles is preferably kept at 2.3 mm or less.

Next, the length of the filler particles, the naturalness of facial movement and the efficiency of the procedure will be described. If the length of the filler particles is larger than 5.5 mm, the facial movement becomes unnatural. Filler particles injected into the subcutaneous fat layer move like a plate. Each particle is arranged partially overlapping with each other, and the overlapping parts become joints and move naturally organically.

However, when the filler particles are larger than 5.5 mm in length, the size of the plate mentioned above becomes too large, so that the shape of the filler particles does not naturally form as the facial muscles move. Therefore, it is preferable to maintain the length of the filler particles to 5.5 mm or less for naturalness. On the other hand, if the length of the filler particles is 4 mm or less, the procedure is cumbersome and the efficiency of volume expansion is lowered.

The invention can be applied throughout face contouring using fillers. That is, it can be generally used for facial contouring using fillers such as ears, cheekbones, temples, nose, lips and jawline, and the position and amount of injection of the fillers are variable according to each treatment site, but the technical idea of the present invention The same applies to the shape and size of the phosphor filler particles.

For example, it is preferable to use an 18 gauge needle because the skin is thinner than other parts of the face, and a filler particle having a width of about 1 mm and a length of about 4 mm is used. This range is included in the width and length range of the filler particles proposed by the present invention.

Next, an embodiment in which the filler of the shape according to the present invention is mixed with fibrin in order to further increase the duration will be described. First, 10 cc of blood is collected, anticoagulant is added to the collected blood, and centrifuged for 10 minutes. Only plasma components are taken from the centrifuged blood and thromboxane is added to form fibrin. Mix the acellular dermis or fascia and fibrin of the shape and size according to the present invention described above and inject it into the treatment site.

Using a fibrin-mixed filler in this way, the mesh foam of fibrin interferes with the recollagement of the cell-free dermis (allodum, shredder) or fascia, delaying the time it is absorbed in vivo. Thus, increasing the duration.

The present invention is not limited to the examples described above, and the rights of the present invention are determined as described in the appended claims. In addition, various modifications of the present invention can be carried out by those skilled in the art, but it is obvious that all belong to the scope of the present invention.

As examined above, according to the shape of the filler particle provided by this invention, the injection amount of a filler can be precisely controlled and there exists an effect which can improve the accuracy of a procedure.

In addition, there is an effect to increase the efficiency of the volume expansion during the procedure to achieve a more satisfactory procedure. In addition, by injecting a filler consisting of acellular dermis, the surface, back and sides of the acellular dermis can be evenly mixed, thereby increasing the engraftment rate of the filler. In addition, by injecting the filler so that the appearance of the facial movements naturally until engraftment, there is an effect to further increase the satisfaction of the procedure.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 shows filler particles obtained by cutting 2 mm × 2 mm of shroud or alloderm, which is a kind of cell-free dermis.

Figure 2 shows the filler particles cut into a streamlined in particular in the shape of rice seed of aloderum or shredder which is a kind of acellular dermis as an embodiment according to the present invention.

Figure 3 shows the filler particles cut into a streamlined, particularly elongated hexagonal shape of aloderum or shredder which is a kind of acellular dermis as an embodiment according to the present invention.

Figure 4 shows the filler particles cut to add a rod-shaped piece on either side as a streamlined, particularly elongated octagonal shape of a cell-like dermis, an aloder or shredder, as an embodiment according to the present invention.

FIG. 5 is a view illustrating a procedure of treating a facial part using the filler illustrated in FIG. 2.

6 is a view for explaining the relationship between the width of the filler particles injected into the subcutaneous fat layer and skin volume expansion.

Fig. 7 shows how filler particles are arranged in a constant direction, i.e., the surface is upward.

8 shows the surface, the back and the sides of the filler particles arranged evenly mixed.

Claims (6)

In the filler processed a cell-free dermis into an injectable form, The head and tail of the filler particles are thin and the body is thick and streamlined. Filler, characterized in that the width of the body portion of the filler particles range from 1 mm to 2.3 mm. The method of claim 1, Filler, characterized in that the length of the filler particles range from 4 mm to 5.5 mm. The method according to claim 1 or 2, The filler particles have a shape of rice seed. The method according to claim 1 or 2, The filler particles are characterized in that the elongated hexagonal shape. The method according to claim 1 or 2, The filler particle has an elongated octagonal shape, and a filler having a rod-shaped thin portion attached to one side thereof is added. The method according to claim 1 or 2, The filler is characterized in that the filler is mixed with fibrin.