KR20190081534A - Expansion rate controlled dental apparatus containing biodegradable materials and preparation method thereof - Google Patents

Abstract

The present invention relates to a gingival expander containing a biodegradable material to control an expansion speed of hydrogels, and a manufacturing method thereof, and more specifically, to a gingival expander which, unlike existing gingival expander adjusting sizes or numbers of pores or holes to control a speed of body fluid inflow, forms a biodegradable polymer sheet on the pores or holes to prevent the gingival expander from expanding while a cut portion in operation is treated for a sufficient treating time to be secured and for a polymer sheet to be decomposed after a tissue is completely cured, and body fluids are introduced through open pores or holes to expand the hydrogels, thereby controlling the expanding speed. The present invention provides a sufficient time for curing tissues while the gingival expander does not expand for a predetermined time after operation, expands the tissues after the tissues are completely cured, and has a high procedure success rate because a procedure is conducted in a state where the tissues are sufficiently cured and stabled.

Description

TECHNICAL FIELD [0001] The present invention relates to a dental instrument having a controlled rate of expansion including a biodegradable material and a method of manufacturing the same,

The present invention relates to a gingival expander including a biodegradable material and controlling the rate of expansion of a hydrogel, and a method of manufacturing the same. More particularly, the present invention relates to a gingival expander that controls the size and number of pores or holes A biodegradable polymer sheet is formed in the pores or holes to keep the gingival expander from being inflated during the healing period of the incision site of the surgery so that a sufficient healing time can be secured, The present invention relates to a gingival expander in which a swelling rate can be controlled by inflow of a body fluid through an opened pore or hole after the polymer sheet is completely healed, thereby expanding the hydrogel.

As a precondition for successful osseointegration and initial stabilization in implant dentistry, an appropriate amount of bone is required around the implant. However, if there is a shortage of bone volume or bone volume before implantation, it may be necessary to consider the case of implantation due to the positioning of the implant for normal prosthesis placement or various reasons , And guided bone regeneration-augmentation (GBR) is used when a part of the implant is exposed to the outside of the bone.

This bone induction regeneration regenerates the bone tissue by forming a space using a barrier at the edentulous region regardless of the periodontal tissue and inducing osteoblast flow into the bone defect portion under the space, In many cases, absorbent, nonabsorbable dental shields and various bone materials (autogenous bone, allogeneic bone, heterogeneous bone, synthetic bone) are used.

It is known that the dental barrier prevents the gingival epithelium that is early to regenerate from reaching the injured part and prevents it from entering, and has a proper space maintenance ability, which helps to differentiate connective tissue and regenerate bone. In this regard, techniques for dental restoration membranes that can improve the success rate of implant treatment by helping the prognosis of bone induction regeneration have been developed.

On the other hand, the shortage of bone mass or bone volume before implantation is accompanied by the degeneration of the gingiva covering the tooth, which makes it difficult to secure space necessary for alveolar bone regeneration. In order to solve this problem, there has been developed a technique of implanting a gingival expander including a hydrogel before the bone induction regeneration procedure and reconstructing the gingival recession, which has been regressed by using the swelling property of the hydrogel, to a normal state before tooth loss Has come.

The need for the procedure of the gingival dilator and the procedure of the procedure more specifically, when the alveolar bone is absorbed and the tooth is lost and the gingiva (soft tissue) The space under the gingiva is already filled up, eventually resulting in a shortage of gingiva (soft tissue) to perform the last suture.

Therefore, it is possible to secure stable clinical treatment results by expanding the gingival recessed to the gingiva before the GBR procedure to the normal gingiva and securing sufficient gingivality (soft tissue) to the GBR procedure. The gingival dilator is removed from the gingiva after implantation of a gingival expander under the recessed gingiva before the GBR procedure and an expansion period of 4 to 6 weeks (gingival expansion period). When the restored gingiva is reconstructed in this manner, a sufficient space for restoration of the alveolar bone can be secured. The gingival expansion technique corresponds to a tissue expanding technique that secures the space necessary for alveolar bone regeneration by expanding the gingival recession using the self-expanding property of the hydrogel prior to the guided bone regeneration (GBR) procedure to the normal state before tooth loss.

In the conventional commercially available gingival expander, a hydrogel that expands by absorbing body fluids is surrounded by a pore or a hole-formed silicon film, and absorbs the body fluids to expand. As a result, the size or number of pores or holes formed in the silicon film The rate of expansion of the hydrogel is controlled by controlling the amount of body fluid being introduced.

However, in this case, since the body fluids flow directly through the pores or holes immediately after the transplantation, expansion of the gingival expander (that is, expansion of the hydrogel) can be started even before complete healing of the surgical incision site. This may put pressure on the organization.

Particularly, it may affect the incompletely incised incision site, causing the suture to burst, or the suture site to spread, resulting in infection. In severe cases, it may result in interruption or failure of the procedure.

Therefore, it is desirable to provide a time for the tissue to be sufficiently cured in a state in which the gingival dilator is not inflated for a certain period of time during which the incision is healed by the operation, and the gingival dilatation can be inflated after the tissue is completely healed, Development of expander is necessary.

Patent No. 10-1668679 Registration Utility Model No. 20-0475611

The present invention relates to a gingival expander which absorbs body fluids and is surrounded by pores or perforated silicone membranes that absorb and expand body fluids, and the amount of body fluids flowing into the pores or holes formed by the existing gingival expanders is controlled And to solve the problems and limitations by controlling the expansion rate.

More specifically, a biodegradable sheet capable of shielding the pores or holes is formed on the surface of a silicon shell including pores or holes into which saliva or liquid can flow, while enclosing the hydrogel in a gingival expander A gingival expander with a controlled rate of expansion that can be inflated after the tissue is fully healed and can be given a time sufficient to allow tissue to heal in a state in which the gingival dilator is not inflated for an initial period of time after surgery, And a method for producing the same.

A gingival expander with controlled expansion rate according to an embodiment of the present invention includes: a hydrogel for absorbing body fluids and swelling to secure a space in the gingiva; And a silicone shell surrounding the hydrogel and including pores or holes into which saliva or fluid may enter, wherein the biodegradable sheet is positioned on the surface of the silicon shell to shield the pores or holes .

Wherein the biodegradable sheet is a natural polymer selected from the group consisting of chitosan, choline, hyaluronic acid, collagen, alginic acid, heparin, starch, xanthan, lignin, cellulose, curdlan, fibrinogen, gelatin, ; Or copolymers of lactic acid and glycolic acid, polyglycolic acid, polyethylene glycol, polycaprolactone, polyautoester, polyphosphazene, polydecavacin, polyhydroxybutyric acid, And a synthetic polymer selected from the group consisting of a copolymer of hydroxybutyric acid and hydroxyvaleric acid and a polyester of succinic acid.

The hydrated gel is preferably a hydrated gel in which a monomer having methacrylate and a monomer having vinyl group are crosslinked. The hydrated gel is preferably a triangular, square, Or an elliptical columnar shape.

In accordance with one embodiment of the present invention, as the biodegradable sheet is decomposed, the saliva or the sap flows through the pores or holes into the inside of the silicone shell, and the carboxyl group on the surface of the hydrogel is ionized, .

Another embodiment of the present invention is a method of manufacturing a gingival expander, comprising: a first step of polymerizing a hydrogel; A second step of modifying the methylene chain of the methacrylate of the hydrated gel into a carboxyl group by subjecting the polymerized hydrated gel to an alkaline treatment; A third step of compressively drying the hydrolyzed gel treated with the alkali agent using a drying mold; A fourth step of placing the compressively dried hydrated gel in a silicon shell having pores or holes through which saliva or liquid can flow into the interior and then joining the ends of the silicon shell using an adhesive; And a fifth step of attaching the biodegradable sheet to shield pores or holes formed in the surface of the silicon shell.

Preferably, the biodegradable sheet is thermally bonded to the surface of the silicon shell.

A gingival dilator with controlled expansion rate according to the present invention is a gingival dilator which surrounds a hydrogel in a gingiva expander and is configured to shield the pores or holes on the surface of a silicon shell including pores or holes into which saliva or liquid can flow, A biodegradable sheet can be placed so that the gingival expander can be given a time sufficient for the tissue to be cured in a state in which the gingival expander is not inflated during the initial period after the operation and can be expanded after the tissue is completely healed, The procedure can be performed in a state where the tissue is sufficiently healed and stabilized, and the effect of having a high procedure success rate is obtained.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a photograph (a) of a gingival expander according to the present invention and Fig. 1 (b) is a schematic diagram showing a specific structure thereof.
FIG. 2 is a result of measuring the decomposition rate of the biodegradable sheet according to an embodiment of the present invention.
FIG. 3 shows the results of measurement of changes in expansion volume with time of the hydrogel according to the sample / control of the biodegradable sheet according to the present invention.

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the drawings. Prior to this, terms and words used in the present specification and claims should not be construed as limited to ordinary or dictionary terms, and should be construed in a sense and concept consistent with the technical idea of the present invention.

Throughout this specification, when an element is referred to as "including" an element, it is understood that it may include other elements as well, without departing from the other elements unless specifically stated otherwise.

Hereinafter, the dental gauge expander of the present invention will be described in detail with reference to the accompanying drawings.

FIG. 1 (a) shows a gingival expander with an inflation rate controlled according to an embodiment of the present invention, and FIG. 1 (b) schematically shows a specific form.

The gingiva expander according to the present invention shown in FIG. 1 includes a hydrogel 100 capable of swelling by absorbing body fluids and the hydrogel 100, and has a pore or hole through which the saliva or liquid can flow into the inside, (200), wherein the biodegradable sheet (400) is positioned on the surface of the silicon shell (200) to shield the pores or holes.

The joining portion 500 may be formed on both sides or at least one side of the silicone shell 200 so as to surround the hydrogel 10. The joining portion 500 of the silicone shell and the screw As shown in FIG. When a screw is used on both side joints 500 of the silicone shell 200, there is an advantage that it is perfectly fixed to the alveolar bone and movement in the gingival is prevented.

The hydrogel absorbs body fluid to secure a space in the gingiva through swelling in the body. Preferably, the hydrogel contains a monomer having a methacrylate group and a monomer having a vinyl group Crosslinked polymers may be used.

The hydrated gel 100 in which the monomer having methacrylate and the monomer having vinyl group are cross-linked is prepared by mixing methyl methacrylate (MMA) and vinyl-pyrrolidone (VP) (HEMA) and vinyl-pyrrolidone (VP), or n-methacrylate (n = 4, 8, 12; n = 4: butyl methacrylate, n = 8: octylmethacrylate, n = 12: lauryl methacrylate) and vinyl-pyrrolidone (VP).

When the body fluid is absorbed by the hydrogel 100, the -COOH functional groups of the methacrylate (methacrylate) that comprise the hydrogels 100 -COO ^- and is dissociated into H ⁺ -COO ^- cross hydrogel polymer resulting from The repulsive force of the liver is increased, which causes the gap between the polymer chains to become self-swelling capability. The swollen hydrogel 100 is swollen in a round cylinder shape that allows the gingiva to swell broadly regardless of its initial shape.

The hydrogel of the gingival expander is dried under various pressure conditions using various types of drying molds for the convenience of the procedure, so that the shape of the hydrogel can be controlled. Preferably, a polygonal column can be used. It is more preferable that the cross section of the multi-stranded hydrogel is a regular polygon having 3 to 8 sides and the contact area of the hydrated gel with the alveolar bone is 0.35 to 1.5 cm ² .

In addition, the hydrogel may be of a streamlined type. The streamlined hydrogel is preferably a flat streamlined type having a narrower width toward one side or both sides. Such a streamlined hydrogel may be easily inserted into the gingiva Because of its flat shape, the area of contact with the alveolar bone is widened during the procedure, and it is placed in the gingiva, which increases the convenience of the procedure.

The silicon shell 200 is a perforated or semipermeable membrane, and holes (pores or holes) are formed so that body fluids or liquids can permeate. In the case of a conventional gingival expander, the presence or absence and the number of holes of the silicone shell 200 Has controlled the rate of diffusion of body fluids inside the gingival expander.

However, when such pores or holes are simply formed on the surface of the silicone shell 200, since the body fluid is directly introduced through the pores or holes after the gingival expander is implanted, The hydration gel begins to swell or swell without healing, resulting in an increase in the volume of the gingival dilator. This can result in compression of the tissue, especially when the incision is not completely healed, resulting in suture loosening or suture site infections. In severe cases, the procedure may be interrupted or failed have.

Therefore, in the present invention, by using the biodegradable sheet 400 capable of shielding the pores or holes 300 formed on the surface of the silicone shell 200, the flow of body fluid after the implantation of the gingival expander is blocked, The biodegradable sheet 400 is decomposed to a predetermined level or higher, and the bodily fluids are introduced through the pores or holes 300 to control the time point at which the gingival expander expands.

As the biodegradable sheet 400, it is preferable to use a natural polymer or a synthetic polymer harmless to the human body, and specifically, chitosan, chylin, , Fibrinogen, gelatin, fluoran, and polyamino acid; Or copolymers of lactic acid and glycolic acid, polyglycolic acid, polyethylene glycol, polycaprolactone, polyautoester, polyphosphazene, polydecavacin, polyhydroxybutyric acid, And a synthetic polymer selected from the group consisting of a copolymer of hydroxybutyric acid and hydroxyvaleric acid and a polyester of succinic acid.

The decomposition time of the biodegradable sheet 400 to be used at this time can be controlled through the molecular weight of the biodegradable material or the thickness of the sheet. Thus, when the body fluid is absorbed into the hydrogel through the pores or holes 300, I.e., the time point at which the hydrogel begins to expand.

The biodegradable sheet 400 may be manufactured in the form of a patch having a biodegradable material formed thereon, and may be thermo-compressed and fixed in a region where pores or holes are formed in the silicon shell.

The biodegradable sheet produced in the form of a patch is a sheet made of a polymer material such as polystyrene (PS), polyvinyl chloride (PVC), polymethyl methacrylate (PMMA), polyethylene terephthalate (PET) Or by forming a biodegradable material such as a natural polymer or a synthetic polymer harmless to the human body on the surface by spray coating or dip coating method.

The biodegradable material formed on the surface of the biodegradable sheet 400 has a function of shielding the pores or holes of the silicon shell for a certain period of time in the body and then losing the shielding function from about 70% .

[Example 1]

(MMA), vinyl-pyrrolidone (VP), 2-vinylpyrrolidone (VP), and the like are mixed so that the crosslinked methyl methacrylate (MMA) , 0.1 wt% of 2'-azobisisobutylonitrile (polymerization initiator), 0.2 wt% of hydroxypropyl methacrylate (crosslinking agent), and methylpyrrolidone (solvent) After being so blended, the blend was thermally polymerized at a temperature of 65 DEG C for 24 hours

The methylene chain of the methacrylate of the hydrated gel was reformed into a carboxyl group by alkali treatment using the alkaline agent NaOH, and the resulting polymerized hydrogel was compressed and dried using a drying mold.

Thereafter, the compressed and dried hydrated gel was placed inside a silicon shell having a hole with a diameter of 0.5 mm so that the saliva or the solution could flow into the inside, and then the end was bonded.

The biodegradable sheet is thermocompression bonded at a temperature of about 85 degrees so as to block holes formed in the surface of the silicon shell. The biodegradable sheet preferably has a weight average molecular weight of 50,000 to 10,000, PLGA of 80,151 was used, which was extruded to a thickness of 1 mm and then cut into sheets.

[Example 2]

The biodegradation rate of the biodegradable sheet prepared in Example 1 was confirmed by loading the biodegradable sheet in PBS (Phosphate Buffered Saline, pH 7.0-7.4) solution, stirring at about 200 rpm at 37 ° C, And the weight was measured with elapsed time.

3 shows the results of measuring the expansion volume over time of a gingival dilator (sample) according to the present invention to which the biodegradable sheet of FIG. 2 was applied and a gingiva control without biodegradable sheet applied The size and number of holes formed are kept the same).

As can be seen from the results of FIG. 3, in the case of the gingival expander in which the pores or holes of the silicon shell were shielded through the biodegradable sheet, the volume of the biodegradable sheet began to increase from about 5 days later. In the case of a non-gingival expander, it can be confirmed that the volume has continuously increased from the beginning.

3, it can be seen that the volume of the gingival expander is increasing from the time when about 70% of the biodegradable material is decomposed and the remaining amount is about 30% in FIG. 2. As a result, Can be controlled.

[Example 3]

The biodegradation rate was confirmed by changing the molecular weight of PLGA, a biodegradable polymer used in the production of biodegradable films. The concrete manufacturing process and the experiment of measuring the biodegradation rate are the same as in the first embodiment, and the results are summarized in FIG.

As can be seen from the results of FIG. 4, the biodegradation rate of the biodegradable film was changed by controlling the molecular weight of the biodegradable film, which means that the expansion time of the gingival expander can be effectively controlled.

Claims (8)

A hydrogel for absorbing body fluids and swelling to secure a space in the gingiva; And
And a silicone shell surrounding the hydrogel and including pores or holes through which saliva or fluid can flow into the interior,
Wherein the biodegradable sheet is positioned on the surface of the silicon shell to shield the pores or holes.
The method according to claim 1,
Wherein the biodegradable sheet comprises:
A natural polymer selected from the group consisting of chitosan, choline, hyaluronic acid, collagen, alginic acid, heparin, starch, xanthan, lignin, cellulose, curdlan, fibrinogen, gelatin, pullulan and polyamino acid; or
Polylactic acid, a styrenic polymer of polylactic acid, a copolymer of lactic acid and glycolic acid, polyglycolic acid, polyethylene glycol, polycaprolactone, polyautoester, polyphosphazene, polydecavacin, polyhydroxybutyric acid, A copolymer of hydroxybutyric acid and hydroxybutyric acid, a copolymer of hydroxybutyric acid and hydroxybutyric acid, and a polyester of succinic acid.
The method according to claim 1,
Characterized in that the hydrogel is a hydrogel in which a monomer having methacrylate and a monomer having vinyl group are crosslinked.
The method according to claim 1,
Wherein the hydrogel is a triangular prism, a square prism, a prismatic prismatic prism, or an elliptical prismatic prism.
The method according to claim 1,
Characterized in that as the biodegradable sheet is decomposed, the saliva or the sap flows into the inside of the silicon shell through pores or holes, and the carboxyl group on the surface of the hydrogel is ionized to expand the hydrogel. Gingival expander.
A method of manufacturing a gingival expander,
A first step of polymerizing the hydrogel;
A second step of modifying the methylene chain of the methacrylate of the hydrated gel into a carboxyl group by subjecting the polymerized hydrated gel to an alkaline treatment;
A third step of compressively drying the hydrolyzed gel treated with the alkali agent using a drying mold;
A fourth step of placing the compressively dried hydrated gel in a silicon shell having pores or holes through which saliva or liquid can flow into the interior and then joining the ends of the silicon shell using an adhesive; And
And attaching a biodegradable sheet to cover pores or holes formed in the surface of the silicon shell.
The method according to claim 6,
Wherein the biodegradable sheet is thermally bonded to the surface of the silicon shell and adhered thereto.
The method according to claim 6,
Wherein the biodegradable sheet comprises:
A natural polymer selected from the group consisting of chitosan, choline, hyaluronic acid, collagen, alginic acid, heparin, starch, xanthan, lignin, cellulose, curdlan, fibrinogen, gelatin, pullulan and polyamino acid; or
Polylactic acid, a styrenic polymer of polylactic acid, a copolymer of lactic acid and glycolic acid, polyglycolic acid, polyethylene glycol, polycaprolactone, polyautoester, polyphosphazene, polydecavacin, polyhydroxybutyric acid, Wherein the material is a material selected from the group consisting of a copolymer of hydroxybutyric acid and hydroxybutyric acid and a polyester of succinic acid.

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