KR20160003506A - Pressed object for medical implant - Google Patents

Abstract

The present invention relates to a compression receptor for a medical implant, and more particularly, a compression receptor for a medical implant according to the present invention includes a key change from a hydrogel state to compression and dehydration condensation with a greater shrinkage rate than simple shrinkage by dehydration condensation .
According to the present invention, it is possible to improve the ease of operation and to prevent the problem such as the necrosis of the tissue of the human body even when the pouch is broken and the contents are leaked to the human body by including the physiological saline solution harmless to the human body and the synthetic resin having high human- .

Description

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BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a compression receptor for a medical implant and a method of manufacturing the same. More particularly, the present invention relates to a receptor that can be accommodated in a medical implant to improve touch and human fitness.

Medical implants are used for the purpose of restoring a damaged body such as a depression due to accident or illness of injuries or improving the appearance of a woman's chest. May be used, for example, to restore the volume of the chest that may be needed after tumor removal, or to aesthetically improve the shape of the chest.

In the case of implants for women's breasts, liquid implants, that is, implants with silicone-type silicone implants, have been developed in hard-type silicone pouches of 1 to 2 mm in thickness.

However, in the case of such a type of implant, when the silicone pouch is broken and the inner silicone gel flows out to the human body, the silicone gel may be absorbed into the human body tissue, causing the necrosis of the tissue.

For this reason, efforts have been made to increase the biocompatibility of silicone pouches by replacing silicone gel with physiological saline or cohesive gel by reducing the likelihood of breakage by making two ply hard pouches.

However, when the hard type silicon pouch is doubled, there is a problem in that the strength is strong, causing a heterogeneous touch which is different from the touch of the human body, and still there is a risk of breakage.

In addition, in the case of implants that replaced silicone gel with physiological saline, there was a problem such that the feeling was not good and the subject himself / herself felt a sense of heterogeneity at the time of daily life. In the case of implants using Kochische gel, There is a problem in that the strength is so strong that the deformation of the shape causes a different feeling from the human body.

Thus, the implant for human body should have a similar feeling to the human body, have high fitness for human body or stability, and should not be heterogeneous in shape similar to human body. The incision site of the human body should be minimized during surgery.

The present invention provides a filling member for a medical implant which can simultaneously improve ease of operation and spatial efficiency in the manufacturing / distribution process.

In addition, the present invention provides a filling member improved in human fitness so that a problem does not occur even when the implants are broken and the contents are leaked to the human body.

In addition, the present invention provides a filling member having improved human fitness and improved tactility as compared to a conventional sanitary saline or Kohsib gel-loaded implant.

Further, the present invention provides a filling member for a medical implant, which can minimize the natural and heterogeneous feeling of shape deformation even in daily life.

The compression receptacle for a medical implant according to the invention comprises a key exchange from the hydrogel state which is compressed and dehydrated and condensed at a greater shrinkage rate than the shrinkage by simple dehydration condensation.

In addition, the key exchange may be made of at least one of PVA (polyvinyl alcohol) and PVAc (polyvinyl acetate).

Also, the key exchange may be formed of a porous material.

In addition, the key exchange may be made of a biocompatible material.

The gun replacement may also be manufactured to have a volume greater than the maximum compressible volume and having a volume that is less than or equal to the volume of the object to be accommodated.

Also, the key exchange may be formed in the shape of any one of a lump, a strap and a plate.

On the other hand, a method of manufacturing a compression receptor for a medical implant according to the present invention includes: providing a water-soluble synthetic resin; A softening step of softening the water-soluble synthetic resin through hydrolysis; Compressing the softened water-soluble synthetic resin; And a dehydrating condensation step of dehydrating or drying the compressed water-soluble synthetic resin.

The providing step may further include the step of preparing a PVA sponge from PVA or PVAc.

Also, the PVA sponge may be prepared by mixing PVA and water to obtain a PVA aqueous solution; Introducing and stirring a pore-forming agent into the PVA aqueous solution; And heating and acetalizing the mixture after the stirring step.

The PVA sponge may be prepared by hydrolyzing PVAc to obtain a PVA aqueous solution; Introducing and stirring a pore-forming agent into the PVA aqueous solution; And heating and acetalizing the mixture after the stirring step.

Further, in the compression step, the softened water-soluble synthetic resin can be compressed by any one of rolling, folding, pressing, or a combination of two or more methods.

According to the present invention, it is possible to minimize the incision site of the patient at the time of surgery by artificially adding a compression process before manufacture of the key exchange.

According to the present invention, there is an effect of preventing the problem such as the necrosis of the tissue of the human body and the like, even when the pouch is broken and the contents are leaked to the human body, by including the physiological saline solution harmless to the human body and the synthetic resin having high human fitness.

According to the present invention, by including PVA and PVAc in the form of a hydrogel, the human fitness can be improved, and a feeling similar to that of a human body can be felt as compared with a case in which only physiological saline solution is accommodated or the Kochisberg having high strength is accommodated.

In addition, according to the present invention, it is possible to minimize the natural and heterogeneous feeling of shape deformation even in daily life compared with physiological saline having weak viscosity or Kohish gel having high viscosity.

1 is a schematic view showing a medical implant according to an embodiment of the present invention.
2 is a block diagram illustrating a method of manufacturing a water soluble synthetic resin and a gun replacement for a medical implant according to one embodiment.
3 is a schematic diagram illustrating a method of making and using a gun replacement for a medical implant according to one embodiment.
4 is a cross-sectional view illustrating a medical implant according to one embodiment.
5 is a cross-sectional view showing a medical implant according to another embodiment.
6 and 7 are cross-sectional views illustrating a medical implant according to another embodiment.
8 is a cross-sectional view illustrating a medical implant according to another embodiment.
FIGS. 9 and 10 are perspective views schematically showing a conventional medical implant and a medical implant of FIG. 8, respectively.
11 and 12 are cross-sectional views showing combinable embodiments.
13 is a cross-sectional view showing a medical implant according to another embodiment.

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. In the absence of special definitions or references, the terms used in this description are based on the conditions indicated in the drawings. The same reference numerals denote the same members throughout the embodiments. For the sake of convenience, the thicknesses and dimensions of the structures shown in the drawings may be exaggerated, and they do not mean that the dimensions and the proportions of the structures should be actually set.

A medical implant according to an embodiment of the present invention will be described with reference to FIG. 1 is a schematic view showing a medical implant according to an embodiment of the present invention.

As shown in FIG. 1, the medical implant 100 according to the present embodiment may be inserted into the human body B, in particular, a woman's chest region. 1 and the related description are illustrative for convenience of explanation, and are not limited to the operation of the female breast of the medical implant 100. That is, medical implants can be applied to various parts of the human body through size and shape changes in addition to the use for women's breast surgery.

The medical implant 100 according to the present embodiment includes a pouch 110, a physiological saline solution W and a filler member 120. The pouch 110 is formed of a hard type silicone material to form the external shape of the implant 100, and may have some elasticity or no elasticity according to purposes. The physiological saline solution W and the receiver 120 are accommodated in the pouch 110. In the interior of the pouch 110, the receptacle 120 is provided in a state softened by physiological saline (W).

The receptor 120 may be formed of a water-soluble synthetic resin and may be provided inside the pouch 110 in a softened state by being hydrolyzed by physiological saline solution W. In this case, PVA (polyvinyl alcohol) and PVAc (polyvinyle acetate) may be used as the water-soluble synthetic resin.

The receptor 120 is made of xerogel and then reacts with physiological saline solution W in the pouch 110 to be present as a hydrogel.

A hydrogel is a state in which when a substance is placed in a larger amount of water, the substance can swell quickly and maintain a large amount of water in the swollen structure. The material that exists in the hydrogel state maintains a three-dimensional structure rather than dissolving in water. A gel that has been structured in such an aqueous solution is referred to as a hydrogel. Hydrogels are usually made of hydrophilic polymers that are crosslinked by other binding forces, such as chemical bonds, ionic interactions, hydrogen bonding or hydrophobic action.

The term hydrogel applies when the material has already swelled in water. The dried gel is called a xerogel or dry gel. During the drying process, moisture evaporates from the gel, and surface tension causes the gel itself to crumble. The gel therefore shrinks to a very small fraction of the swollen size. If moisture is removed by freeze drying or by extraction with an organic solvent without disturbing the polymer structure, then the remaining material will have an extremely light weight with high porosity. The hydrogel thus dehydrogenated is called xerogel or sponge.

Hereinafter, for convenience of explanation, the receptor in the preparation step or the receptor dried in the physiological saline is referred to as dry change, and the receptor contained in physiological saline is referred to as a hydrogel in particular.

On the other hand, polyvinyl alcohol (PVA) is a hydrophilic polymer synthetic resin obtained through hydrolysis of polyvinyl acetate (PVAc). Cross-linking of PVA is achieved through chemical and physical methods. Chemical cross-linking is the formation of a gel by combining a hydroxyl group and an aldehyde-based solution of PVA with an acidic cross-linking agent. A typical method of physical crosslinking is freeze-thawing. The hydrogel prepared by the freeze-thaw process has little toxicity and does not contain any impurities, and contains about 80 to 90% of water. Also, since it does not use a crosslinking agent, it can be used as an attractive biomedical hydrogel.

That is, in the case of the silicone gel, when the outermost pouch is broken, there is a fear that it flows out and is absorbed into the living tissue to cause necrosis. On the other hand, in the case of the PVA hydrogel as in this embodiment, Even if it is kept in a certain shape, there is less possibility of leakage to the outside, and even if it is leaked, biocompatibility is high and there is no possibility of necrosis of the living tissue.

2 and 3, a receptor according to an embodiment and a manufacturing method thereof will be described. FIG. 2 is a block diagram illustrating a method of manufacturing a gun replacement for a water soluble synthetic resin and a medical implant according to an embodiment, and FIG. 3 is a schematic diagram illustrating a method of manufacturing and using a gun replacement for a medical implant according to an embodiment.

The PVA gun replacement is characterized in that it is excellent in elasticity in a wet state and is very soft while it hardens in a dry state, so that it can be used not only for cleaning cleaning rollers for semiconductor wafers, cleaning and transporting rollers for TFT LCD glass , A medical gauze, a beauty towel, a sports towel, a kitchen scaffolding mat, and a material for microbial coatings.

PVA, a raw material for PVA gun replacement, is a white powder that does not dissolve in ordinary organic solvents other than water. To maintain a stable state. It is used as a pulp of fabric, sizing of paper, emulsification stabilizer and so on. This PVA is used as a raw material to manufacture a PVA gun replacement (S10). PVA and water are mixed at a certain ratio and heated to obtain an aqueous PVA solution. Then, corn starch and the like are added as a pore forming agent, formalin is added thereto and stirred, and then sulfuric acid (H2SO4) After that, it is injected into a mold prepared in advance, heated and acetalized, and the PVA gun is replaced. The acetalized PVA gun replacement is extracted from the mold, thoroughly cleaned, cut and processed according to the standard to commercialize.

This method of manufacturing a PVA sponge has a problem in that formalin or paraformaldehyde, which is a regulated substance used, must be used in spite of the tendency that regulations on the use of harmful substances are spreading.

It is also possible to manufacture the PVA gun replacement by using the following method in order to avoid the use of environmentally controlled substances and to improve the environment of the manufacturing workplace.

First, 16 ~ 21% of PVA resin is weighed and mixed with water. To 25 to 45% of the PVA aqueous solution according to the ratio of pores to be formed with corn starch and the like as a porogen in the PVA aqueous solution. Separately, 28 to 35% of hexamethylene tetramine by weight of water was added to the water, Or more to obtain an aqueous solution of hexamethylenetetramine.

PVA and hexamethylenetetramine aqueous solution were obtained by adding 12 to 18% aqueous hexamethylenetetramine aqueous solution of PVA aqueous solution to the PVA aqueous solution and stirring to obtain an aqueous solution of sulfuric acid having a dilution concentration of about 50% 19 ~ 21% is input. After that, it is injected into a mold prepared in advance and placed in an oven. And heated (aged) for 29 to 34 hours at a temperature to be acetalized. The acetalized PVA sponge is extracted from the mold, thoroughly cleaned, and cut and processed according to the standard to produce a product.

(S20). However, the softening step of the present invention is merely required to perform the subsequent compression step (S30), and the same step as the providing step of the water soluble synthetic resin (S10) , And it is not necessarily performed in a separate step from the water-soluble synthetic resin providing step (S10).

On the other hand, when the hydrogel-type receptor is dehydrated and condensed and dried, as described above, the moisture is released, and the volume is reduced and solidified at the same time. However, when dehydration and condensation of a hydrogel-like receptor is simply performed, the volume reduction is insufficient. Therefore, in this embodiment, the compression process is further performed before drying or dehydration condensation of the hydrogel-like receptor. In the compressing step S30 according to the present embodiment, the compressing process is performed using one or more of the following methods: rolling up, folding, twisting, pressing, and the like in a hydrogel state It is possible to do.

Thereafter, the compressed receptor may be dried or dehydrated to a dry state (S40).

3, the receptor (HG) in the softened state is converted into dry gas replacement (XG) through compression (II) and dehydration condensation (III) before drying and then hydrolysis is induced again To a hydrogel (HG) state (IV).

Hereinafter, medical implants according to various embodiments will be described. Also, in the following embodiments, it is desirable to prepare implants using the compressed gun replacement described above. By manufacturing the medical implant using compressed gun replacement, it is possible to minimize the incision site of the patient during surgery or to improve the spatial efficiency of storage and transportation in the manufacturing process.

First, referring to FIG. 4, a medical implant according to an embodiment will be described. 4 is a cross-sectional view illustrating a medical implant according to one embodiment.

The medical implant 100 according to the present embodiment is characterized in that the receptacle 120 provided inside the pouch 110 is formed as a single solid body.

Specifically, the pouch 110 forms the contour of the medical implant 100. The pouch 110 is preformed to have a volume and shape according to the desired volume and shape. The pouch 110 may be manufactured using hard type silicon used for medical use.

A physiological saline solution W similar to a body component is provided inside the pouch 110 and a receiver 120 is provided as a single solids in the saline solution W.

The receptors 120 may be formed in various sizes and shapes depending on the volume and elasticity of the desired medical implant 100. When compressed gun replacement is used, the gun replacement is manufactured to account for the volume to be expanded when the gun replacement is converted to the hydrogel state. In order to increase or decrease the elasticity of the manufactured medical implant 100, it is possible to adjust the volume of gun replacement to be larger or smaller. However, considering that the gun replacement is expanded, it is preferable that the size of the gun replacement itself is made not to exceed the volume of the pouch 110.

On the other hand, as described above, it is preferable that the gun replacement is made in the form of a porous material or a sponge to further improve the expansion and shrinkage of the volume.

The medical implant 100 manufactured in this way has improved tactile sensation due to the PVA and PVAc contained in the hydrogel state unlike the medical implant having only the physiological saline solution. Even if the pouch 110 is broken, It is harmless to the human body due to leakage, and even when PVA or PVAc hydrogel flows out, biocompatibility is high, so that there is no problem such as tissue necrosis.

A medical implant according to another embodiment will be described with reference to FIG. 5 is a cross-sectional view showing a medical implant according to another embodiment.

This embodiment differs from the embodiment of FIG. 4 described above in that the receptors 120a included therein are divided into a plurality of solid bodies.

That is, the receptor 120a may be contained in the pouch 110 as a small mass having a certain size instead of being contained in a single solid body. In this case, the position of the receiver 120a in the pouch 110 can be more easily secured in the process of expanding the receiver 120a than the above-described embodiment.

Other conditions such as the condition of the receptor 120a are not much different from the embodiments described above.

A medical implant according to another embodiment will be described with reference to Figs. 6 and 7. Fig. 6 and 7 are cross-sectional views illustrating a medical implant according to another embodiment.

The present embodiment is different from the above-described embodiment in that it has a structure and structure for maximizing easiness in operation.

The medical implant 100b according to the present embodiment does not include physiological saline solution in the manufacturing step.

Specifically, in the manufacturing step, as shown in Fig. 6, the cartridge replacement of the receptor 120b in the pouch 110 is made, preferably a compressed cartridge replacement is accommodated. However, an inlet 112 is provided on one side of the pouch 110. The inlet 112 serves as a valve through which the fluid can flow, and it is preferable to use a one-way valve so that the fluid can be easily injected and the introduced fluid does not flow out to the outside.

The medical implant 100b thus manufactured can be used for surgery. For example, physiological saline can be injected through the inflow section 112 after inserting the medical implant shown in FIG. 6 through the incision site during surgery of the patient. In this case, as shown in FIG. 7, the receiver 120b is swollen by the inflowed physiological saline W and is restored to its volume and shape before being compressed. As the saline solution flows into the pouch 110 and the inner receptacle 120b expands, the medical implant 100b has the intended volume, shape, and elasticity in the patient's body.

As shown in FIG. 6, during surgery, the body is inserted into the patient's body in a state in which the body can be deformed into a minimized volume and easy insertion. On the other hand, after the body is inserted into the body, The same effects as those of the above-described embodiments can be obtained, so that the incision site of the patient can be minimized.

A medical implant according to another embodiment will be described with reference to Figs. 8 to 12. Fig. 9 and 10 are perspective views schematically showing a conventional medical implant and a medical implant of FIG. 8, respectively, FIGS. 11 and 12 are cross-sectional views of a medical implant according to another embodiment Sectional views showing embodiments.

The medical implant 100c according to the present embodiment differs from the medical implant 100c in that a receptacle 120c for forming a separate layer is provided on the inner wall of the pouch 110 as shown in FIG. At this time, the receptacle 120c may be attached to the entire inner wall of the pouch 110, or may be attached to only a part of the inner wall of the pouch 110 where wrinkles are likely to be formed. At this time, the receiver 120c may be formed in the shape of a strap, a plate, or the like.

In the case of a conventional implant using a single silicone pouch, wrinkles are formed in the implant according to the use state as shown in FIG. 9, and such wrinkles are reflected in the external shape of the human body as a whole to cause problems in appearance . In order to compensate for this, when using a silicone pouch having two or more layers, problems may occur in terms of tactile or shape as described above.

However, in the case where a receptor is attached to the inner wall of the silicon pouch to form a separate layer as in the present embodiment, since the receptor is present as a hydrogel in physiological saline, the thickness of the pouch is compensated for It is possible to prevent the formation of wrinkles as shown in Fig. 10 as much as possible.

The formation of a layer using a separate receptor on the inner side of the pouch can be implemented together with each of the embodiments described above. For example, as shown in FIG. 11, it is also possible to have another receiver 120 formed as a single solid body inside the receiver 120c forming a separate layer, and as shown in FIG. 12, It is also possible to have other receptors 120a formed into a plurality of solid bodies inside the receptors 120c forming the receptors 120a and 120b.

A medical implant according to another exemplary embodiment will be described with reference to Fig. 13 is a cross-sectional view showing a medical implant according to another embodiment.

The medical implant 100f according to the present embodiment has a peculiar effect in that it employs two pouches 110a and 110b to more effectively prevent breakage of the pouch 110. [

Specifically, as shown in FIG. 13, the pouch 110 may be composed of two layers of an inner pouch 110b and an outer pouch 110a. The inner pouch 110b and the outer pouch 110a may be formed of the same component and the inner pouch 110b and the outer pouch 110a may be filled with the silicone gel 115. [

Instead of the silicone gel 115, it is also possible to replace the silicone gel 115 with a PVA hydrogel in order to improve the tactile sensation.

The other internal structures are not different from the previously described embodiments, and each embodiment may be applied or a combination of the embodiments.

While the present invention has been described with reference to exemplary embodiments, it is to be understood that the invention is not limited to the disclosed exemplary embodiments, but, on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims. have.

100, 100a, 100b, 100c, 100d, 100e: medical implant
110, 110a, 110b: pouch
120, 120a, 120b, 120c:

Claims (11)

A compression receptor for a medical implant, comprising a key exchange for compression and dehydration condensation with a greater shrinkage rate than the shrinkage due to simple dehydration condensation from the hydrogel state. The method according to claim 1,
Wherein the key exchange is made of at least one material selected from the group consisting of PVA (polyvinyl alcohol) and PVAc (polyvinyl acetate). The method according to claim 1,
Wherein said gun replacement is formed of a porous material. The method according to claim 1,
Wherein the key exchange is formed of a biocompatible material. The method according to claim 1,
Wherein the key exchange is manufactured to have a volume greater than the maximum compressible volume and having a volume that is less than or equal to the volume of the article to be accommodated. The method according to claim 1,
Wherein the key exchange is formed in the shape of a lump, a strap and a plate. Providing a water-soluble synthetic resin;
A softening step of softening the water-soluble synthetic resin through hydrolysis;
Compressing the softened water-soluble synthetic resin; And
And a dehydrating condensation step of dehydrating or drying the compressed water-soluble synthetic resin. 8. The method of claim 7,
Wherein the providing step further comprises preparing a PVA sponge from PVA or PVAc. 9. The method of claim 8,
The PVA sponge manufacturing step may include:
Mixing PVA and water to obtain a PVA aqueous solution;
Introducing and stirring a pore-forming agent into the PVA aqueous solution;
And heating and acetalizing the mixture after the stirring step. 10. The method of claim 9,
The PVA sponge manufacturing step may include:
Hydrolyzing PVAc to obtain an aqueous PVA solution;
Introducing and stirring a pore-forming agent into the PVA aqueous solution;
And heating and acetalizing the mixture after the stirring step. 8. The method of claim 7,
Wherein the softening water-soluble synthetic resin is compressed by any one of rolling-up, folding, pressing, or a combination of two or more methods in the compression step.

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