WO2016052860A1 - Dental gingiva expander having improved operation convenience - Google Patents

Dental gingiva expander having improved operation convenience Download PDF

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WO2016052860A1
WO2016052860A1 PCT/KR2015/008754 KR2015008754W WO2016052860A1 WO 2016052860 A1 WO2016052860 A1 WO 2016052860A1 KR 2015008754 W KR2015008754 W KR 2015008754W WO 2016052860 A1 WO2016052860 A1 WO 2016052860A1
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hydrogel
gingival
gingiva
swelling
polygonal
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PCT/KR2015/008754
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French (fr)
Korean (ko)
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김민경
신승화
최다미
송주동
엄태관
최규옥
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오스템임플란트 주식회사
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Publication of WO2016052860A1 publication Critical patent/WO2016052860A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00Dilators with or without means for introducing media, e.g. remedies

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  • the present invention relates to a dental gingival expander, and more particularly, the insertion into the gingiva using a narrow column of a hydrogel or one side of a hydrogel or an elliptic cylinder having a wide contact area with the alveolar bone and the gingiva.
  • the streamlined hydrogel eases, the invention relates to a gingival expander having a structure surrounded by a silicon shell bonded to both ends, there is an advantage that can be used to expand the tissue of the desired area and the convenience of the procedure.
  • the bone-induced regeneration is a procedure to secure bone space by using a barrier membrane at the gingival area irrespective of the periodontal tissue, and to induce the introduction of osteoblasts into the bone defect in the lower part of the space to promote bone tissue regeneration.
  • the bone guided regeneration procedure is generally used for absorbing or non-absorbing dental barrier, and various bone materials such as autologous bone, allogeneic bone, xenograft and synthetic bone.
  • Dental barrier membranes are known to prevent the rapid regeneration of gingival epithelium to grow and enter the damaged area first, and to maintain proper space to help connective tissue differentiation and bone regeneration. Therefore, techniques for dental barrier membranes that can further improve the success rate of implant procedures because they help the prognosis of the bone guided regeneration procedure have been actively studied.
  • the self-expansible tissue expansion member (Gewebeexpander) presented in U.S. Patent No. 5496368 (registered on March 5, 1996) is for making a hollow space for conjugating transplanted tissue or for arranging tissue for self-transplantation.
  • a tissue dilator is presented that includes a polymer that absorbs and swells body fluids or water.
  • the tissue expander presented in US Pat. No. 6282116 (registered on May 8, 2001) is mainly composed of a silicone balloon, and the tissue expander is introduced into an area requiring expansion, and then swells for a predetermined time by injecting a saline solution. Proposed organization expanders.
  • the gingival dilator equipped with the periodontal tissue regeneration function disclosed in Korean Patent Publication No. 2013-0108118 (published on October 02, 2013) can shorten the gingival expansion time, thereby reducing the implant procedure time and sustaining release of the growth factor in the gingival dilator.
  • This study suggests a gingival dilator that can restore the gingival tissue weakened by rapid tissue expansion in a short time.
  • the conventional tissue expander takes 6 to 8 weeks to expand the tissue when implanted into the depressed gingiva, or the inserted tissue expander fails to settle in the gingival, protrudes into the incision and adversely affects the healing of the incision. Since there is a problem, the development of a tissue dilator that can increase the rate of gingival fixation and obtain the effect of tissue expansion of the desired area is still required.
  • the present invention is to solve the above-mentioned problems, to reduce the swelling time of the gingival, and to provide a gingival dilator that can obtain the expansion effect of the desired area in the gingiva.
  • the hydrogel of the gingival expander has a round cylindrical shape, and in order to compensate for the problem that the contact area is narrow when inserted after the gingival incision, it does not settle out of the gingiva, and thus, a polygonal hydrogel and an elliptic cylinder.
  • a polygonal hydrogel and an elliptic cylinder To present the gingival dilator containing the type hydrogel and streamlined hydrogel, and to reduce the volume before swelling of the hydrogel to reduce the incision site and to improve the convenience of the procedure.
  • the gingival dilator proposed in the present invention by placing both sides of the silicone shell as a junction, and completely secured to the alveolar bone, obtains the effect of tissue expansion of the desired site, and has a positive effect on the recovery of the surrounding soft tissue.
  • the polygonal or elliptic columnar hydrogel which absorbs body fluid and secures the gingival space through the body swelling, the hydration It surrounds the gel, and includes a silicon shell including a joint bonded to both sides and a screw for fixing the joint and the alveolar bone of the silicone shell.
  • the hydrogel is a hydrogel crosslinked with a monomer having a methacrylate group and a monomer having a vinyl group.
  • the cross section of the polygonal hydrogel is a regular polygon having 3 to 8 sides, and the contact area of the polygonal hydrogel with the alveolar bone is 0.35 to 1.5 cm 2. to be.
  • the cross-section of the polygonal hydrogel is polygonal, and the length of the linear symmetry axis of the polygon is longer than or equal to the rectangular long axis that meets at a right angle with respect to the linear symmetry axis.
  • the ratio between the longitudinal axis of the elliptic cylindrical hydrogel cross section and the horizontal axis perpendicular to the longitudinal axis is not one.
  • the hydrogel has a flat streamline shape that narrows toward one side or both sides.
  • the silicon shell has a thickness of 200 to 250 ⁇ m, and includes holes having a diameter of 0.3 to 0.7 mm, and both joints and alveolar bones of the silicon shell are fixed using the screws.
  • the gingiva dilator of the present invention is manufactured in the shape of a hydrogel with a polygonal column, an elliptic column, or a streamline, and when inserted under the alveolar periosteum after gingival dissection, the contact area between the hydrogel and the alveolar bone can be increased to increase the seating rate. .
  • the volume before the swelling of the hydrogel is smaller than the volume before the swelling of the hydrogel included in the gingival dilator, so it is easy to insert under the gingival, increasing the convenience of the procedure, and has a fast recovery effect after the procedure due to the reduction of the incision site. have.
  • Figure 1 is a schematic diagram showing a state in which the gingiva is expanded when a conventional gingival dilator is implanted.
  • FIG. 2 is a diagram schematically showing the gingival dilator of the present invention.
  • Figure 3 is observed before and after the swelling (a1, b1) and the post-swelling (a2, b2) form of the conventional round cylindrical hydrogel (a) and the square column hydrogel (b) according to an embodiment of the present invention It is a photograph.
  • Figure 4 is a conventional round cylindrical hydrogel (a) and swelling before (a1, c1) and after swelling (a2, c2) of the top and side of the elliptic cylindrical hydrogel (c) according to another embodiment of the present invention It is a photograph observing the form.
  • FIG. 5 is a conventional round cylindrical hydrogel (a) and the swelling before (a1, d1) and after the swelling (a2, d2) of the top and side of the streamlined hydrogel (d) according to another embodiment of the present invention It is a photograph observing.
  • FIG. 6 is a diagram schematically showing a cross section of a conventional round cylindrical hydrogel and a cross section of a regular polygonal hydrogel according to another embodiment of the present invention.
  • FIG. 7 is a graph showing the contact area with the alveolar bone of the regular polygon pillar hydrogel according to another embodiment of the present invention.
  • Example 12 is a graph comparing the volume before and after swelling of Comparative Example 1 (round cylindrical hydrogel, a) and Example 7 (wired hydrogel, d).
  • Example 13 is a graph comparing the swelling period of the gingival expander according to Comparative Example 1 (round cylindrical hydrogel, a) and Example 1 (square pillar hydrogel, b).
  • 15 is a graph comparing the swelling speed according to the thickness of the silicon shell of the present invention.
  • an axis of symmetry refers to an axis that overlaps when a figure is symmetric about a straight line.
  • a straight line that completely overlaps when a certain line is folded with a straight line on its center axis as a folding line
  • the long axis is the longest length of the right angle axis that meets the line symmetry axis in the polygon and forms an angle of 90 degrees. It means a right angle axis with.
  • the gingival dilator of the present invention is a gingival dilator that is implanted into the gingiva before the guided bone regeneration-augmentation (GBR), the hydration that absorbs body fluids to secure the gingival space through swelling in the body It includes a gel (10), a silicone shell 20 surrounding the hydrogel (10), the bonding portion 23 is bonded to both sides and a screw for fixing the bonding portion 23 and the alveolar bone of the silicone shell.
  • GLR guided bone regeneration-augmentation
  • the hydration gel 10 serves to secure the gingival space through swelling in the body by absorbing body fluid, and preferably, a monomer having a methacrylate group and a monomer having a vinyl group are crosslinked. Bound polymers can be used.
  • a -COOH functionality of methacrylate (methacrylate) that make up the hydrogel (10) -COO - and is dissociated into H + -COO - cross hydrogel polymer resulting from The repulsive force of the liver is increased, which leads to the expansion of the spacing between the polymer chains and thus the self-swelling ability.
  • the swelled hydrogel 10 is swelled in a round cylindrical shape that can expand the gingiva generally broadly, regardless of its initial shape.
  • the silicon shell 20 is a porous or semi-permeable membrane, the hole is preferably formed so that the body fluid or the fluid can penetrate. Therefore, by controlling the presence and the number of holes of the silicon shell 20, it is possible to control the diffusion rate of the body fluid inside the gingival dilator.
  • the diameter of the hole of the silicon shell 20 is preferably 0.3 to 0.7 mm.
  • the diameter is less than 0.3 mm, the amount of bodily fluid entering the silicon shell 20 is small so that the swelling speed of the hydrogel 10 is reduced. It is difficult to obtain a maximum expansion volume within a desired period (4 weeks), and when the hole diameter of the silicon shell 20 exceeds 0.7 mm, the amount of body fluid entering the silicon shell 20 increases, thereby increasing the amount of the hydrogel 10 ) Rapid swelling, which can cause strong tension on the incision, adversely affecting the healing of the incision.
  • Both sides of the silicone shell 20 may include a joint 23 bonded with an adhesive. Both junctions 23 of the silicon shell 20 are fixed to the alveolar bone using a screw.
  • the silicone shell of the conventional gingival expander fixed only one side with the alveolar bone so that movement of the gingiva occurs after the procedure, but the gingival expander of the present invention uses a screw on both sides of the joint 23 of the silicon shell 20 by using a screw. It is perfectly fixed and prevents movement within the gingiva. Therefore, the tissue can be expanded to a desired area, and there is no movement of the gingival dilator inside the gingival, thus helping to recover the surrounding soft tissue.
  • FIG. 3 before the swelling of the conventional round cylindrical hydrogel (FIG. 3 a) and the square pillar hydrogel (FIG. 3 b) according to an embodiment of the present invention (a1 or b1 of FIG. 3). ) And the picture after swelling (a2 or b2 in FIG. 3).
  • the hydrogel of the gingival expander of the present invention is dried under pressurized conditions using various types of drying molds in order to increase convenience during the procedure, thereby controlling the shape of the hydrogel.
  • the hydrogel may be modified in various forms as necessary, and the form is preferably a polygonal column shape.
  • the cross section of the polygonal hydrogel is a regular polygon having a number of sides of 3 to 8,
  • the contact area of the hydrogel with the alveolar bone is 0.35 to 1.5 cm2 to be.
  • the contact area of the hydrogel having a regular polygonal cross section exceeds 1.5 cm 2, the initial volume of the hydrogel is also increased, resulting in a large incision site during the procedure, which slows recovery after the procedure, and when the contact area is less than 0.35 cm 2, the periodontal period Lower settling rate with the bone is less convenient for the procedure.
  • the cross-section of the polygonal hydrogel is polygonal, and the length of the line symmetry axis of the polygon is longer than or equal to the rectangular long axis which meets at right angles with respect to the line symmetry axis. Accordingly, the cross section of the polygonal hydrogel may be used as a polygon of various shapes, and the shape of the polygon is not particularly limited.
  • the elliptic column-type hydrogel has a cross section in which the ratio between the vertical axis and the horizontal axis perpendicular to the vertical axis is not one.
  • FIG. 5 before the swelling of the conventional round cylindrical hydrogel (FIG. 5 a) and the streamlined hydrogel (FIG. 5 d) according to another embodiment of the present invention (a1 and d1 in FIG. 5). It is a photograph comparing the appearance after swelling (a2 and d2 in Figure 5).
  • the streamlined hydrogel is preferably a flat streamline that becomes narrower toward one or both sides. Therefore, the streamlined hydrogel has an advantage of being easily inserted into the gingiva during the procedure by using a narrow part of one side, and due to the flat shape, the contact area with the alveolar bone is widened during the procedure, and the convenience of the procedure is increased. do.
  • FIG. 6 and 7 are schematic diagrams showing cross sections of a conventional cylindrical cylindrical hydrogel and a regular polygon pillar hydrogel, which is an embodiment of the present invention, respectively (FIG. 6) and a contact area between the regular polygon hydrogel and the alveolar bone.
  • a graph (FIG. 7) is shown.
  • Table 1 shows the length of one side and the contact area between the alveolar bone according to the round cylindrical and regular polygonal hydrogels fixed with a height of 1.5 cm and 0.42 ml. Referring to FIG. 7 and Table 1, the volume is 0.42 ml.
  • the contact area between the hydrogel and the alveolar bone is the widest, and as the number of angles increases, the contact area becomes narrower.
  • the contact area is preferably 0.35 to 1.5 cm 2.
  • the contact area exceeds 1.5 cm 2, accordingly, the initial volume of the hydrogel is also increased to increase the incision site during the procedure, and if the contact area is less than 0.35 cm 2, the rate of settlement with the periodontal bone is low, thereby reducing the convenience of the procedure.
  • the regular polygonal hydrogel is wider in contact area with the alveolar bone due to the prismatic surface, and the seating rate is increased, and the movement of the gingiva inside the gingiva is minimal, and the convenience of the procedure is increased.
  • hydrogels prepared in the same manner as in Comparative Examples 1 to 3 were placed in a square column-shaped compression mold, and compressed and dried for 5 hours by applying an average 8 MPa pressure and an average temperature of 60 ° C. to prepare Examples 1 to 3.
  • hydrogels prepared in the same manner as in Comparative Examples 1 to 3 were placed in an elliptic cylindrical compression mold, and compressed and dried for 5 hours by adding an average 8 MPa pressure and an average temperature of 60 ° C. to prepare Examples 4 to 6.
  • Example 7 0.55 ml of the methyl methacrylate (MMA) and vinyl-pyrrolidone (VP) cross-linked hydrogels were put in a flat streamlined compression mold and subjected to compression drying for 5 hours by applying an average 8 MPa pressure and an average temperature of 65 ° C.
  • Example 7 was prepared.
  • Examples 1 to 7 and Comparative Examples 1 to 3 were swelled by immersion in saline for 40 days in an incubator at 37 ° C.
  • FIG. 8 is a volume before and after swelling of the comparative examples 1 to 3 of the conventional round cylindrical hydrogel (a in FIG. 8) and the square pillar hydrogel (b in FIG. 8) according to Examples 1 to 3 of the present invention.
  • 9 is a graph comparing the conventional round cylindrical hydrogels (a in FIG. 9), and Comparative Examples 1 to 3 and elliptic cylindrical hydrogels according to Examples 4 to 6 of the present invention (c in FIG. 9). ) Is a graph comparing the volume before and after swelling.
  • Examples 1 to 6 have a smaller volume before swelling than Comparative Examples 1 to 3, so that the incision site becomes smaller during the procedure, so that the recovery is faster, and the small volume facilitates the insertion under the gingiva.
  • FIG. 11 is the maximum expansion rate (Q) of the conventional round cylindrical hydrogel (a in FIG. 11) Comparative Examples 1 to 3 and the elliptic cylindrical hydrogel (c in FIG. 11) according to Examples 4 to 6 of the present invention ),
  • the average value of the maximum expansion rate (Q) of the Comparative Examples 1 to 3 is 4.97
  • the average value of the maximum expansion rate (Q) of the Examples 1 to 3 was 6.4 it was confirmed that the excellent swelling characteristics. .
  • FIG. 12 is a graph comparing a volume before and after swelling of Comparative Example 1, which is a conventional round cylindrical hydrogel (a in FIG. 12) and a streamlined hydrogel (d in FIG. 12), which is a seventh embodiment of the present invention.
  • the volume before swelling of 1 and Example 7 was 0.15 ml and 0.05 ml, but became 0.7 ml and 0.5 ml after swelling.
  • the streamlined hydrogel of the present invention has a small volume before swelling, and has a flat streamline shape that narrows toward one side or both sides, so that it is easy to insert during the procedure, and the incision is small, so that the recovery is faster.
  • Comparative Example 1 As shown in FIG. 13, the initial volume of the hydrogel before swelling in Comparative Example 1 (a in FIG. 13) was 0.15 ml, and the initial volume of the hydrogel before swelling in Example 1 (b in FIG. 13) was 0.1 ml. Although gradually swelled with the body fluid introduced through the silicon hole, the volume after swelling is equal to 0.7 ml, Comparative Example 1 takes a swelling time of 40 days until swelling is completed in a volume of 0.7 ml, Example 1 It was confirmed that the need for 27 days of swelling time.
  • Example 1 of the present invention has the advantage of having a short swelling time compared to Comparative Example 1, since the volume before the swelling Example 1 is smaller than Comparative Example 1 is easy to insert under the gingival incision during the procedure It was found that the decrease and convenience increased.
  • the diameter of the hole of the silicon shell is preferably 0.3 to 0.7 mm. If the diameter is less than 0.3 mm, the amount of body fluid entering the silicon shell is small and the swelling speed of the hydrogel is low, making it difficult to obtain a maximum expansion volume within a desired period (4 weeks), and the hole diameter of the silicon shell is 0.7 mm. If exceeded, the amount of body fluid entering the silicone shell increases, leading to rapid swelling of the hydrogel, which may exert strong tension on the incision and adversely affect the healing of the incision.
  • the thickness of the silicon shell is preferably 200 to 250 ⁇ m. If the thickness of the silicon shell is less than 200 ⁇ m, the swelling speed is increased. If the swelling speed is faster than appropriate, there is a problem that a strong tension is applied to the incision to adversely affect the healing of the incision. In addition, when the thickness of the silicon shell exceeds 250 ⁇ m, the swelling speed is slowed and it takes a long time to expand the tissue.
  • the present invention relates to a dental gingival expander, a streamlined type that facilitates insertion into the gingival using a narrow or partial portion of a hydrogel or hydrogel of a polygonal or elliptic column type having a wide contact area with the alveolar bone and gingiva.
  • the hydrogel has a structure surrounded by a silicon shell bonded to both ends.
  • the gingiva dilator of the present invention has the effect of providing the convenience of the procedure and expanding the tissue of the desired area, there is industrial applicability.

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Abstract

The present invention relates to a dental gingiva expander and, more particularly, to a gingiva expander surrounded with a silicone shell, hydrogel being bonded to both sides of the gingiva expander in the shape of a polygonal post or an elliptical post, which increases the area of contact with the alveolar bone and the gingiva, or in the shape of a streamline, which facilitates insertion into the gingiva using a narrow portion on one side thereof. The gingiva expander is advantageous in that, since the hydrogel is manufactured in the shape of a polygonal post, an elliptical post, or a streamline, the area contact between the hydrogel and the alveolar bone is increased, during insertion beneath the periosteum after gingiva incision, thereby increasing the rate of successful seating; the volume before swelling is decreased, compared with hydrogel included in conventional gingiva expanders, thereby facilitating insertion beneath the gingiva and improving the convenience in operation; and the reduced area of incision quickens recovery after operation.

Description

시술 편의성이 향상된 치과용 치은확장기Dental gingival expander with improved convenience
본 발명은 치과용 치은확장기에 관한 것으로서, 보다 상세하게는 치조골 및 치은과의 접촉면적이 넓은 다각기둥형 또는 타원기둥형의 수화젤 또는 수화젤 일측의 폭이 좁은 부분을 이용하여 치은 내 삽입을 편하게 하는 유선형의 수화젤이, 양단부가 접합된 실리콘 쉘에 의해 둘러 싸여진 구조를 갖는 치은 확장기에 관한 발명으로, 이를 사용하여 시술의 편의성과 원하는 부위의 조직을 확장시킬 수 있는 장점이 있다.The present invention relates to a dental gingival expander, and more particularly, the insertion into the gingiva using a narrow column of a hydrogel or one side of a hydrogel or an elliptic cylinder having a wide contact area with the alveolar bone and the gingiva. The streamlined hydrogel eases, the invention relates to a gingival expander having a structure surrounded by a silicon shell bonded to both ends, there is an advantage that can be used to expand the tissue of the desired area and the convenience of the procedure.
치과에서 임플란트의 시술 시, 성공적인 치조골 유착과 초기 안정을 위한 전제 조건으로 임플란트 식립체 주위에 적당량의 치조골이 요구된다. 따라서, 임플란트의 식립 전 치조골 량 또는 치조골 부피의 부족이 예상되거나, 임플란트 식립 시 정상적인 보철물 제작을 위한 식립체의 위치 설정에 따라 식립체가 노출될 경우, 또는 임플란트 식립 후에 염증에 의한 치조골 흡수 등의 다양한 이유로 식립체의 일부가 치조골 밖으로 노출되었을 때 골 유도 재생술(Guided Bone Regeneration-augmentation : GBR)이 시술된다. In dentistry, an appropriate amount of alveolar bone is required around the implant implant as a prerequisite for successful alveolar bone adhesion and initial stability. Therefore, the lack of alveolar bone volume or alveolar bone volume before implantation is expected, or when the implant is exposed according to the positioning of the implant for the production of a normal prosthesis during implant placement, or the absorption of the alveolar bone due to inflammation after implant placement For this reason, guided bone regeneration-augmentation (GBR) is performed when part of the implant is exposed to the alveolar bone.
상기 골 유도 재생술은, 치주조직과는 무관하게 무치악 부위에서 차단막을 사용하여 공간을 확보하고, 이 공간 하부의 골결손부 내로 조골세포(Osteoblast)의 유입을 유도함으로써 골조직 재생을 도모하는 시술이다.The bone-induced regeneration is a procedure to secure bone space by using a barrier membrane at the gingival area irrespective of the periodontal tissue, and to induce the introduction of osteoblasts into the bone defect in the lower part of the space to promote bone tissue regeneration.
상기 골 유도 재생술의 시술은 일반적으로 흡수성 또는 비흡수성 치과용 차단막과, 자가골, 동종골, 이종골 및 합성골 등 다양한 골재료가 이용된다. 치과용 차단막은, 재생이 빠른 치은 상피가 먼저 자라나서 손상부로 들어가지 못하게 막아주고, 적당한 공간을 유지하여 결합 조직의 분화와 골 재생에 도움을 주는 것으로 알려져 있다. 따라서, 상기 골 유도 재생술의 시술 예후에 도움을 주기 때문에 임플란트 시술의 성공률을 보다 향상시킬 수 있는 치과용 차단막에 관한 기술이 활발하게 연구되고 있다.The bone guided regeneration procedure is generally used for absorbing or non-absorbing dental barrier, and various bone materials such as autologous bone, allogeneic bone, xenograft and synthetic bone. Dental barrier membranes are known to prevent the rapid regeneration of gingival epithelium to grow and enter the damaged area first, and to maintain proper space to help connective tissue differentiation and bone regeneration. Therefore, techniques for dental barrier membranes that can further improve the success rate of implant procedures because they help the prognosis of the bone guided regeneration procedure have been actively studied.
한편, 임플란트 식립 전의, 골량 또는 골 부피의 부족은 치아를 덮고 있는 치은의 퇴축을 유발하여 치조골 재생에 필요한 공간이 적어지는 문제점이 있다. 따라서, 도 1에 제시된 것처럼, 골 유도 재생술의 시술 전에 수화젤(hydrogel)이 포함된 치은 확장기를 이식시켜, 수화젤의 팽윤 성질을 통해 퇴축된 치은을 확장시켜 치조골 재생에 필요한 공간을 충분히 확보하여 이러한 문제점을 해결할 수 있다.On the other hand, lack of bone mass or bone volume before implant placement causes a problem that the space required for alveolar bone regeneration is reduced by causing retraction of the gingiva covering the tooth. Therefore, as shown in Figure 1, before the operation of bone-induced regeneration procedure by implanting a gingival dilator containing a hydrogel, by expanding the depressed gingiva through the swelling properties of the hydrogel to secure enough space for alveolar bone regeneration This problem can be solved.
미국특허공보 제5496368호 (1996.03.05 등록)에 제시된 자기 확장성 조직 확장 부재(Gewebeexpander)은 이식 조직을 접합하기 위한 중공 공역을 만들거나 또는 자가 이식을 위한 조직을 정돈하기 위한 것으로, 상기 자기 확장 부재가 조직 내에 이식되면 체액 또는 수분을 흡수하여 팽윤하는 폴리머를 포함한 조직 확장기를 제시하고 있다.The self-expansible tissue expansion member (Gewebeexpander) presented in U.S. Patent No. 5496368 (registered on March 5, 1996) is for making a hollow space for conjugating transplanted tissue or for arranging tissue for self-transplantation. When the member is implanted into a tissue, a tissue dilator is presented that includes a polymer that absorbs and swells body fluids or water.
미국특허공보 제6228116호 (2001.05.08 등록)에 제시된 조직 확장기는 실리콘 벌룬을 주체로 하는 것이며, 상기 조직 확장기는 확장이 필요로 하는 영역에 도입된 후, 생리식염수를 주입하여 일정한 시간을 들여 팽윤되는 조직 확장기를 제시하고 있다.The tissue expander presented in US Pat. No. 6282116 (registered on May 8, 2001) is mainly composed of a silicone balloon, and the tissue expander is introduced into an area requiring expansion, and then swells for a predetermined time by injecting a saline solution. Proposed organization expanders.
공개특허 제2013-0108118호 (2013.10.02 공개)에 제시된 치주조직 재생기능이 탑재된 치은 확장기는, 치은 확장시간을 단축시킴으로서 임플란트 시술시간을 단축시킬 수 있고, 치은확장기 내 성장인자의 지속방출을 통해 빠른 조직확장으로 인해 약해진 치은 조직을 단시간 내 회복시킬 수 있는 치은 확장기를 제시하고 있다. The gingival dilator equipped with the periodontal tissue regeneration function disclosed in Korean Patent Publication No. 2013-0108118 (published on October 02, 2013) can shorten the gingival expansion time, thereby reducing the implant procedure time and sustaining release of the growth factor in the gingival dilator. This study suggests a gingival dilator that can restore the gingival tissue weakened by rapid tissue expansion in a short time.
하지만 종래의 조직 확장기는 퇴축된 치은 내에 이식 시, 조직을 확장시키는데 6 ~ 8 주간의 장시간이 소요되거나, 삽입된 조직 확장기가 치은 내에서 안착하지 못하고, 절개부위로 돌출되어 절개부의 치유에 악영향을 미치는 문제점이 발생하므로, 치은 내 안착률을 높히고, 원하는 부위의 조직 확장 효과를 얻을 수 있는 조직 확장기의 개발이 여전히 요구되고 있다.However, the conventional tissue expander takes 6 to 8 weeks to expand the tissue when implanted into the depressed gingiva, or the inserted tissue expander fails to settle in the gingival, protrudes into the incision and adversely affects the healing of the incision. Since there is a problem, the development of a tissue dilator that can increase the rate of gingival fixation and obtain the effect of tissue expansion of the desired area is still required.
본 발명은 상술한 문제점을 해결하기 위한 것으로, 치은 팽윤 시간을 단축시키고, 치은 내 원하는 부위의 확장 효과를 얻을 수 있는 치은 확장기를 제공하고자 한다.The present invention is to solve the above-mentioned problems, to reduce the swelling time of the gingival, and to provide a gingival dilator that can obtain the expansion effect of the desired area in the gingiva.
또한, 종래의 치은 확장기의 수화젤이 둥근 실린더형으로 되어 있어, 치은 절개 후 삽입 시, 접촉면적이 좁아 안착하지 못하고 치은 밖으로 빠져나오는 문제를 보완하기 위해 본 발명에서는 다각기둥형 수화젤, 타원기둥형 수화젤 및 유선형 수화젤이 포함된 치은 확장기를 제시하고, 상기 수화젤의 팽윤 전 부피를 감소시킴으로서 절개 부위의 감소와 시술의 편의성을 높이고자 한다.In addition, in the present invention, the hydrogel of the gingival expander has a round cylindrical shape, and in order to compensate for the problem that the contact area is narrow when inserted after the gingival incision, it does not settle out of the gingiva, and thus, a polygonal hydrogel and an elliptic cylinder. To present the gingival dilator containing the type hydrogel and streamlined hydrogel, and to reduce the volume before swelling of the hydrogel to reduce the incision site and to improve the convenience of the procedure.
본 발명에서 제시하는 치은 확장기는, 실리콘 쉘의 양측을 접합부로 두어, 치조골에 완벽하게 고정시킴으로써, 원하는 부위의 조직 확장 효과를 얻고, 주변 연조직의 회복에 긍정적인 효과를 갖는다.The gingival dilator proposed in the present invention, by placing both sides of the silicone shell as a junction, and completely secured to the alveolar bone, obtains the effect of tissue expansion of the desired site, and has a positive effect on the recovery of the surrounding soft tissue.
상술한 바와 같은 목적을 달성하기 위하여 본 발명의 시술의 편의성이 향상된 치과용 치은 확장기는, 체액을 흡수하여, 체내 팽윤을 통해 치은 내 공간을 확보하는 다각기둥형 또는 타원기둥형 수화젤, 상기 수화젤을 둘러싸고, 양측이 접합된 접합부가 포함되는 실리콘 쉘 및 상기 실리콘 쉘의 접합부와 치조골을 고정시키는 스크류를 포함한다.Dental gingival expander with improved convenience of the procedure of the present invention to achieve the object as described above, the polygonal or elliptic columnar hydrogel, which absorbs body fluid and secures the gingival space through the body swelling, the hydration It surrounds the gel, and includes a silicon shell including a joint bonded to both sides and a screw for fixing the joint and the alveolar bone of the silicone shell.
상기 수화젤은 메타크릴레이트(Methacrylate) 기를 갖는 모노머와 비닐(vinyl) 기를 갖는 모노머가 가교결합된 수화젤이다.The hydrogel is a hydrogel crosslinked with a monomer having a methacrylate group and a monomer having a vinyl group.
상기 다각기둥형 수화젤의 단면은 변의 수가 3 내지 8인 정다각형이고, 상기 다각기둥형 수화젤의 치조골과의 접촉면적이 0.35 내지 1.5 ㎠ 이다.The cross section of the polygonal hydrogel is a regular polygon having 3 to 8 sides, and the contact area of the polygonal hydrogel with the alveolar bone is 0.35 to 1.5 cm 2. to be.
또는, 상기 다각기둥형 수화젤의 단면은 다각형이고, 상기 다각형의 선대칭축의 길이가 상기 선대칭축을 기준으로 직각으로 만나는 직각장축보다 길거나 같다.Alternatively, the cross-section of the polygonal hydrogel is polygonal, and the length of the linear symmetry axis of the polygon is longer than or equal to the rectangular long axis that meets at a right angle with respect to the linear symmetry axis.
상기 타원기둥형 수화젤 단면의 종축과 상기 종축에 수직인 횡축의 비가 1이 아니다.The ratio between the longitudinal axis of the elliptic cylindrical hydrogel cross section and the horizontal axis perpendicular to the longitudinal axis is not one.
본 발명의 다른 실시예에 따른 시술의 편의성이 향상된 치과용 치은 확장기는, 체액을 흡수하여, 체내 팽윤을 통해 치은 내 공간을 확보하는 유선형의 수화젤, 상기 수화젤을 둘러싸고, 양측이 접합된 접합부가 포함되는 실리콘 쉘 및 상기 실리콘 쉘의 접합부와 치조골을 고정시키는 스크류를 포함한다.Dental gingival expander with improved convenience of the procedure according to another embodiment of the present invention, a streamlined hydrogel to secure the gingival space through swelling in the body by absorbing body fluid, surrounding the hydrogel, the joint portion is joined to both sides It includes a silicon shell and a screw for fixing the junction and the alveolar bone of the silicon shell.
상기 수화젤은 일측 또는 양측으로 갈수록 폭이 좁아지는 납작한 유선형이다.The hydrogel has a flat streamline shape that narrows toward one side or both sides.
상기 실리콘 쉘의 두께는 200 ~ 250 ㎛ 이고, 지름이 0.3 ~ 0.7 ㎜ 인 홀을 포함하고, 상기 실리콘 쉘의 양측 접합부와 치조골이 상기 스크류를 이용하여 각각 고정된다.The silicon shell has a thickness of 200 to 250 μm, and includes holes having a diameter of 0.3 to 0.7 mm, and both joints and alveolar bones of the silicon shell are fixed using the screws.
본 발명의 치은 확장기는, 수화젤의 형태를 다각기둥형 또는 타원기둥형이나 유선형으로 제조되어 치은 절개 후 치조골막 아래로 삽입될 때, 상기 수화젤과 치조골의 접촉면적을 늘려 안착률을 높일 수 있다. 상기 수화젤의 팽윤 전 부피는 종래의 치은 확장기에 포함되는 수화젤의 팽윤 전 부피보다 작아, 치은 아래에 삽입이 용이하여 시술의 편의성이 증가하고, 절개 부위의 감소로 시술 후 회복이 빠른 효과가 있다.The gingiva dilator of the present invention is manufactured in the shape of a hydrogel with a polygonal column, an elliptic column, or a streamline, and when inserted under the alveolar periosteum after gingival dissection, the contact area between the hydrogel and the alveolar bone can be increased to increase the seating rate. . The volume before the swelling of the hydrogel is smaller than the volume before the swelling of the hydrogel included in the gingival dilator, so it is easy to insert under the gingival, increasing the convenience of the procedure, and has a fast recovery effect after the procedure due to the reduction of the incision site. have.
또한, 실리콘 쉘의 양측 접합부를 각각 스크류를 이용하여 치조골에 고정함으로써, 이식된 치은 확장기의 이동을 방지하여, 치은 내 원하는 부위에 확장 효과를 얻을 수 있다.In addition, by fixing both sides of the silicon shell to the alveolar bone by using screws, respectively, it is possible to prevent the movement of the implanted gingival dilator, thereby obtaining an expansion effect on a desired area of the gingiva.
도 1은 종래 치은 확장기를 이식한 경우의 치은이 확장된 모습을 개략적으로 나타낸 모식도이다.Figure 1 is a schematic diagram showing a state in which the gingiva is expanded when a conventional gingival dilator is implanted.
도 2는 본 발명의 치은 확장기를 도식적으로 나타낸 그림이다.2 is a diagram schematically showing the gingival dilator of the present invention.
도 3은 기존의 둥근 실린더형 수화젤(a)과 본 발명의 일 실시예에 따른 사각기둥형 수화젤(b)의 팽윤 전(a1, b1)과 팽윤 후(a2, b2) 형태를 관찰한 사진이다.Figure 3 is observed before and after the swelling (a1, b1) and the post-swelling (a2, b2) form of the conventional round cylindrical hydrogel (a) and the square column hydrogel (b) according to an embodiment of the present invention It is a photograph.
도 4는 기존의 둥근 실린더형 수화젤(a)과 본 발명의 다른 실시예에 따른 타원기둥형 수화젤(c)의 윗면과 측면의 팽윤 전(a1, c1)과 팽윤 후(a2, c2) 형태를 관찰한 사진이다.Figure 4 is a conventional round cylindrical hydrogel (a) and swelling before (a1, c1) and after swelling (a2, c2) of the top and side of the elliptic cylindrical hydrogel (c) according to another embodiment of the present invention It is a photograph observing the form.
도 5는 종래의 둥근 실린더형 수화젤(a)과 본 발명의 또 다른 실시예에 따른 유선형 수화젤(d)의 윗면과 측면의 팽윤 전(a1, d1)과 팽윤 후(a2, d2) 형태를 관찰한 사진이다.5 is a conventional round cylindrical hydrogel (a) and the swelling before (a1, d1) and after the swelling (a2, d2) of the top and side of the streamlined hydrogel (d) according to another embodiment of the present invention It is a photograph observing.
도 6은 종래의 둥근 실린더형 수화젤의 단면과 본 발명의 또 다른 실시예에 따른 정다각기둥형 수화젤의 단면을 도식적으로 나타낸 그림이다.6 is a diagram schematically showing a cross section of a conventional round cylindrical hydrogel and a cross section of a regular polygonal hydrogel according to another embodiment of the present invention.
도 7은 본 발명의 또 다른 실시예에 따른 정다각기둥형 수화젤의 치조골과의 접촉면적을 나타낸 그래프이다.7 is a graph showing the contact area with the alveolar bone of the regular polygon pillar hydrogel according to another embodiment of the present invention.
도 8은 비교예 1 내지 3(둥근 실린더형 수화젤, a)과 실시예 1 내지 3(사각기둥형 수화젤, b)의 팽윤 전후 부피를 비교한 그래프이다.8 is a graph comparing volumes before and after swelling of Comparative Examples 1 to 3 (round cylindrical hydrogels, a) and Examples 1 to 3 (square prismatic gels, b).
도 9는 비교예 1 내지 3(둥근 실린더형 수화젤, a)과 실시예 4 내지 6(타원기둥형 수화젤, c)의 팽윤 전후 부피를 비교한 그래프이다.9 is a graph comparing the volumes before and after swelling of Comparative Examples 1 to 3 (round cylindrical hydrogels, a) and Examples 4 to 6 (elliptic cylindrical hydrogels, c).
도 10은 비교예 1 내지 3(둥근 실린더형 수화젤, a)과 실시예 1 내지 3(사각기둥형 수화젤, b)의 최대 팽창율을 비교한 그래프이다.10 is a graph comparing the maximum expansion ratio of Comparative Examples 1 to 3 (round cylindrical hydrogel, a) and Examples 1 to 3 (square pillar hydrogel, b).
도 11은 비교예 1 내지 3(둥근 실린더형 수화젤, a)과 실시예 4 내지 6(타원기둥형 수화젤, c)의 최대 팽창율을 비교한 그래프이다.11 is a graph comparing the maximum expansion ratios of Comparative Examples 1 to 3 (round cylindrical hydrogels, a) and Examples 4 to 6 (elliptic cylindrical hydrogels, c).
도 12는 비교예 1(둥근 실린더형 수화젤, a)과 실시예 7(유선형 수화젤, d)의 팽윤 전후 부피를 비교한 그래프이다.12 is a graph comparing the volume before and after swelling of Comparative Example 1 (round cylindrical hydrogel, a) and Example 7 (wired hydrogel, d).
도 13는 비교예 1(둥근 실린더형 수화젤, a)과 실시예 1(사각기둥형 수화젤, b)에 따른 치은확장기의 팽윤 기간을 비교한 그래프이다. 13 is a graph comparing the swelling period of the gingival expander according to Comparative Example 1 (round cylindrical hydrogel, a) and Example 1 (square pillar hydrogel, b).
도 14은 본 발명의 실리콘 쉘의 홀 크기에 따른 팽윤 속도를 비교한 그래프이다.14 is a graph comparing the swelling speed according to the hole size of the silicon shell of the present invention.
도 15은 본 발명의 실리콘 쉘의 두께에 따른 팽윤 속도를 비교한 그래프이다.15 is a graph comparing the swelling speed according to the thickness of the silicon shell of the present invention.
이하 도면을 참조하여 본 발명의 바람직한 실시예를 상세히 설명하기로 한다. 이에 앞서, 본 명세서 및 청구범위에 사용된 용어나 단어는 통상적이거나 사전적인 의미로 한정하여 해석되어서는 아니 되며, 본 발명의 기술적 사상에 부합하는 의미와 개념으로 해석되어야 한다.Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings. Prior to this, the terms or words used in the present specification and claims should not be construed as being limited to ordinary or dictionary meanings, but should be construed as meanings and concepts consistent with the technical spirit of the present invention.
본 명세서 전체에서, 어떤 부분이 어떤 구성요소를 "포함" 한다고 할 때, 이는 특별히 반대되는 기재가 없는 한 다른 구성요소를 제외하는 것이 아니라 다른 구성 요소를 더 포함할 수 있는 것을 의미한다.Throughout this specification, when a part is said to "include" a certain component, it means that it can further include other components, without excluding other components unless otherwise stated.
또한, 본 명세서에서 특별한 언급이 없는 한, 선대칭축(axis of symmetry)은 어떤 도형을 한 직선을 중심으로 대칭시켰을 때 겹쳐지는 축을 말한다. 즉, 어떤 도형을 한 직선을 중심축으로 이 직선을 접는 선으로 하여 접었을 때 완전히 겹쳐지는 직선을 의미하며, 직각장축은 다각형 내 선대칭축과 만나서 이루는 각이 90도를 이루는 직각축 중에서 가장 긴 길이를 가지는 직각축을 의미한다.In addition, unless otherwise specified herein, an axis of symmetry refers to an axis that overlaps when a figure is symmetric about a straight line. In other words, a straight line that completely overlaps when a certain line is folded with a straight line on its center axis as a folding line, and the long axis is the longest length of the right angle axis that meets the line symmetry axis in the polygon and forms an angle of 90 degrees. It means a right angle axis with.
이하에서는, 본 발명의 치과용 치은 확장기를 첨부된 도면을 참조하여 상세히 설명하도록 한다.Hereinafter, with reference to the accompanying drawings the dental gingival expander of the present invention will be described in detail.
도 2를 참조하면, 본 발명의 치은 확장기는 골 유도 재생술(Guided Bone Regeneration-augmentation : GBR) 이전, 치은 내로 이식되는 치은 확장기로서, 체액을 흡수하여, 체내 팽윤을 통해 치은 내 공간을 확보하는 수화젤(10), 상기 수화젤(10)을 둘러싸고, 양측이 접합된 접합부(23)가 포함되는 실리콘 쉘(20) 및 상기 실리콘 쉘의 접합부(23)와 치조골을 고정시키는 스크류를 포함한다.Referring to Figure 2, the gingival dilator of the present invention is a gingival dilator that is implanted into the gingiva before the guided bone regeneration-augmentation (GBR), the hydration that absorbs body fluids to secure the gingival space through swelling in the body It includes a gel (10), a silicone shell 20 surrounding the hydrogel (10), the bonding portion 23 is bonded to both sides and a screw for fixing the bonding portion 23 and the alveolar bone of the silicone shell.
상기 수화젤(10)은 체액을 흡수하여 체내 팽윤을 통해 치은 내 공간을 확보하는 역할을 하며, 바람직하게는 메타크릴레이트(Methacrylate) 기을 갖는 모노머(Monomer)와 비닐(Vinyl) 기를 갖는 모노머가 가교 결합된 고분자가 사용될 수 있다. The hydration gel 10 serves to secure the gingival space through swelling in the body by absorbing body fluid, and preferably, a monomer having a methacrylate group and a monomer having a vinyl group are crosslinked. Bound polymers can be used.
상기 메타크릴레이트(methacrylate) 기를 갖는 모노머와 비닐(vinyl) 기를 갖는 모노머가 가교결합된 수화젤(10)은 메틸 메타크릴레이트(MMA)와 비닐-피롤리돈(VP)을 6~7 : 4~3의 질량비로 가교 결합시켜 합성될 수 있으며, 이 외에도 하이드록시에틸 메타크릴레이트(HEMA)와 비닐-피롤리돈(VP)이나, n-메타크릴레이트(n=탄소수,4,8,12)와 비닐-피롤리돈(VP)을 가교결합시켜 합성할 수 있다.(n=4 : butyl methacrylate, n=8 :octyl methacrylate, n=12 : lauryl methacrylate)The hydrogel 10 in which the monomer having a methacrylate group and the monomer having a vinyl group is crosslinked is methyl methacrylate (MMA) and vinyl-pyrrolidone (VP) 6-7: 4. It can be synthesized by crosslinking at a mass ratio of ˜3, in addition to hydroxyethyl methacrylate (HEMA) and vinyl-pyrrolidone (VP), or n-methacrylate (n = carbon number, 4,8,12). ) And vinyl-pyrrolidone (VP) can be synthesized by crosslinking (n = 4: butyl methacrylate, n = 8: octyl methacrylate, n = 12 lauryl methacrylate).
상기 수화젤(10)에 체액이 흡수되면, 수화젤(10)을 구성하고 있는 메타크릴레이트(methacrylate)의 -COOH 작용기가 -COO-와 H+로 해리되고 -COO-로 인한 수화젤 고분자 상호 간의 척력이 증가되고, 이로 인해 고분자 사슬 사이의 간격이 벌어지면서 자가팽윤능력을 갖게 되다. 이렇게 팽윤된 수화젤(10)은 초기의 형태와 관계없이 치은을 전반적으로 넓게 팽창시킬 수 있는 둥근 실린더형으로 팽윤된다.When the body fluid is absorbed into the hydrogel 10, a -COOH functionality of methacrylate (methacrylate) that make up the hydrogel (10) -COO - and is dissociated into H + -COO - cross hydrogel polymer resulting from The repulsive force of the liver is increased, which leads to the expansion of the spacing between the polymer chains and thus the self-swelling ability. The swelled hydrogel 10 is swelled in a round cylindrical shape that can expand the gingiva generally broadly, regardless of its initial shape.
상기 실리콘 쉘(20)은 유공 또는 반투과성 막으로, 체액 또는 수액이 투과할 수 있도록 홀이 형성되는 것이 바람직하다. 따라서, 상기 실리콘 쉘(20)의 홀의 유무 및 갯수를 조절함으로서, 치은 확장기 내부의 체액의 확산 속도를 제어할 수 있다. The silicon shell 20 is a porous or semi-permeable membrane, the hole is preferably formed so that the body fluid or the fluid can penetrate. Therefore, by controlling the presence and the number of holes of the silicon shell 20, it is possible to control the diffusion rate of the body fluid inside the gingival dilator.
본 발명에서는 실리콘 쉘(20)의 홀의 지름이 0.3 ~ 0.7 ㎜이 바람직한데, 이는 지름이 0.3 ㎜ 미만인 경우에는, 체액이 실리콘 쉘(20) 내부로 들어가는 양이 적어 수화젤(10)의 팽윤속도가 느려 원하는 기간(4주) 내에 최대 팽창 부피를 얻기 어렵고, 상기 실리콘 쉘(20)의 홀 지름이 0.7 ㎜ 초과하면, 체액이 실리콘 쉘(20) 내부로 들어가는 양이 많아져 상기 수화젤(10)의 급속한 팽윤을 가져오고, 이는 절개부에 강한 장력이 가해져 절개부의 치유에 악영향을 미칠 수 있다.In the present invention, the diameter of the hole of the silicon shell 20 is preferably 0.3 to 0.7 mm. When the diameter is less than 0.3 mm, the amount of bodily fluid entering the silicon shell 20 is small so that the swelling speed of the hydrogel 10 is reduced. It is difficult to obtain a maximum expansion volume within a desired period (4 weeks), and when the hole diameter of the silicon shell 20 exceeds 0.7 mm, the amount of body fluid entering the silicon shell 20 increases, thereby increasing the amount of the hydrogel 10 ) Rapid swelling, which can cause strong tension on the incision, adversely affecting the healing of the incision.
실리콘 쉘(20)의 양측은 접착제로 접합된 접합부(23)를 포함할 수 있다. 상기 실리콘 쉘(20)의 양측 접합부(23)는 스크류를 이용하여 치조골과 고정된다. 종래의 치은확장기의 실리콘 쉘이 일측부분만 치조골과 고정되어 있어 시술 후 치은 내부의 이동이 발생하였으나, 본 발명의 치은확장기는 상기 실리콘 쉘(20)의 양측 접합부(23)에 스크류를 이용하여 치조골과 완벽하게 고정되어 치은 내에서 이동이 방지된다. 따라서, 원하는 부위에 조직을 확장할 수 있으며, 상기 치은 내부의 치은 확장기의 이동이 없어 주변의 연조직 회복에도 도움을 준다. Both sides of the silicone shell 20 may include a joint 23 bonded with an adhesive. Both junctions 23 of the silicon shell 20 are fixed to the alveolar bone using a screw. The silicone shell of the conventional gingival expander fixed only one side with the alveolar bone so that movement of the gingiva occurs after the procedure, but the gingival expander of the present invention uses a screw on both sides of the joint 23 of the silicon shell 20 by using a screw. It is perfectly fixed and prevents movement within the gingiva. Therefore, the tissue can be expanded to a desired area, and there is no movement of the gingival dilator inside the gingival, thus helping to recover the surrounding soft tissue.
도 3을 참조하면, 종래의 둥근 실린더형 수화젤(도 3의 a)과 본 발명의 일 실시예에 따른 사각기둥형 수화젤(도 3의 b)의 팽윤 전의 모습(도 3의 a1 또는 b1)과 팽윤 후 모습(도 3의 a2 또는 b2)을 관찰한 사진이다. Referring to FIG. 3, before the swelling of the conventional round cylindrical hydrogel (FIG. 3 a) and the square pillar hydrogel (FIG. 3 b) according to an embodiment of the present invention (a1 or b1 of FIG. 3). ) And the picture after swelling (a2 or b2 in FIG. 3).
본 발명의 치은 확장기의 수화젤은 시술시 편의성을 높이기 위하여, 다양한 형태의 건조용 몰드를 이용하여 가압 조건하에서 건조됨으로서, 수화젤의 형태가 제어된다. 상기 수화젤은 필요에 따라 다양한 형태로 변형될 수 있는데, 그 형태는 바람직하게는 다각기둥형이다. The hydrogel of the gingival expander of the present invention is dried under pressurized conditions using various types of drying molds in order to increase convenience during the procedure, thereby controlling the shape of the hydrogel. The hydrogel may be modified in various forms as necessary, and the form is preferably a polygonal column shape.
상기 다각기둥형 수화젤의 단면은, 변의 수가 3 내지 8인 정다각형이고, 상기 수화젤의 치조골과의 접촉면적이 0.35 내지 1.5 ㎠ 이다. 상기 단면이 정다각형인 수화젤의 접촉면적이 1.5 ㎠를 초과하면, 그에 따라 수화젤이 초기 부피 또한 커져 시술시 절개 부위가 커지게 되어 시술 후 회복이 더디게 되고, 접촉면적이 0.35 ㎠ 미만이면, 치주골과의 안착률이 낮아 시술의 편의성이 떨어지게 된다. The cross section of the polygonal hydrogel is a regular polygon having a number of sides of 3 to 8, The contact area of the hydrogel with the alveolar bone is 0.35 to 1.5 ㎠ to be. When the contact area of the hydrogel having a regular polygonal cross section exceeds 1.5 cm 2, the initial volume of the hydrogel is also increased, resulting in a large incision site during the procedure, which slows recovery after the procedure, and when the contact area is less than 0.35 cm 2, the periodontal period Lower settling rate with the bone is less convenient for the procedure.
또는, 상기 다각기둥형 수화젤의 단면이 다각형이고, 상기 다각형의 선대칭축의 길이가 상기 선대칭축을 기준으로 직각으로 만나는 직각장축보다 길거나 같은 다각형이다. 따라서, 상기 다각기둥형 수화젤의 단면은 다양한 모양의 다각형으로 사용할 수 있으며 특별히 다각형의 모양은 한정되지 않는다.Alternatively, the cross-section of the polygonal hydrogel is polygonal, and the length of the line symmetry axis of the polygon is longer than or equal to the rectangular long axis which meets at right angles with respect to the line symmetry axis. Accordingly, the cross section of the polygonal hydrogel may be used as a polygon of various shapes, and the shape of the polygon is not particularly limited.
도 3에 나타난 바와 같이, 다각기둥형 수화젤과 종래의 둥근 실린더형 수화젤의 팽윤 전후를 비교한 사진을 보면, 팽윤 전 초기 형태(도 3의 왼쪽)는 서로 다르지만 팽윤이 진행됨에 따라 치은 확장에 효과적인 둥근 실린더형(도 3의 오른쪽)으로 팽윤됨을 알 수 있으며, 이하의 다른 실시예인 타원기둥형 수화젤(도 4의 c) 및 유선형 수화젤(도 5의 d)에도 동일한 방식으로 관찰하였다.As shown in Figure 3, when comparing the swelling before and after the swelling of the polygonal hydrogel and the conventional round cylindrical hydrogel, the initial shape before the swelling (left of Figure 3) is different from each other, but gingival expansion as the swelling progresses It can be seen that the swelling in a round cylindrical shape (right side of Figure 3) effective for, and was observed in the same manner in the other examples of elliptic columnar hydrogel (FIG. 4) and streamlined hydrogel (D in Figure 5). .
도 4를 참조하면, 종래의 둥근 실린더형 수화젤(도 4의 a)과 본 발명의 다른 실시예에 따른 타원기둥형 수화젤(도 4의 c)의 팽윤 전의 모습(도 4의 a1 및 c1)과 팽윤 후 모습(도 4의 a2 및 c2)을 관찰한 사진이다. 상기 타원기둥형 수화젤의 단면은 종축과 상기 종축에 수직인 횡축의 비가 1이 아닌 형태가 바람직하다. Referring to Figure 4, before the swelling of the conventional round cylindrical hydrogel (Fig. 4a) and the elliptic columnar hydrogel (FIG. 4c) according to another embodiment of the present invention (a1 and c1 in Figure 4) ) And the picture after swelling (a2 and c2 of FIG. 4). The elliptic column-type hydrogel has a cross section in which the ratio between the vertical axis and the horizontal axis perpendicular to the vertical axis is not one.
도 5를 참조하면, 종래의 둥근 실린더형 수화젤(도 5의 a)과 본 발명의 또 다른 실시예에 따른 유선형 수화젤(도 5의 d)의 팽윤 전의 모습(도 5의 a1 및 d1)과 팽윤 후 모습(도 5의 a2 및 d2)을 비교한 사진이다. 상기 유선형 수화젤은 일측 또는 양측으로 갈수록 폭이 좁아지는 납작한 유선형이 바람직하다. 따라서, 상기 유선형 수화젤은 일측의 좁은 부분을 이용하여 시술시 치은 내에 삽입하기 용이한 장점이 있고, 납작한 형태로 인하여, 시술시 치조골과의 접촉면적이 넓어져 치은 내에 안착되어 시술의 편의성이 증가된다.Referring to FIG. 5, before the swelling of the conventional round cylindrical hydrogel (FIG. 5 a) and the streamlined hydrogel (FIG. 5 d) according to another embodiment of the present invention (a1 and d1 in FIG. 5). It is a photograph comparing the appearance after swelling (a2 and d2 in Figure 5). The streamlined hydrogel is preferably a flat streamline that becomes narrower toward one or both sides. Therefore, the streamlined hydrogel has an advantage of being easily inserted into the gingiva during the procedure by using a narrow part of one side, and due to the flat shape, the contact area with the alveolar bone is widened during the procedure, and the convenience of the procedure is increased. do.
이하에서는 본 발명에 따른 바람직한 실시예를 통해 상세히 설명하기로 한다.Hereinafter will be described in detail through a preferred embodiment according to the present invention.
[실험예1] 수화젤의 단면적에 따른 치조골과의 접촉면적 비교 [Experimental Example 1] Comparison of Contact Area with Alveolar Bone by Cross-sectional Area of Hydrogel
도 6과 7에는 각각 종래의 둥근 실린더형의 수화젤과 본 발명의 일 실시예인 정다각기둥형 수화젤의 단면을 나타낸 모식도(도 6)와 상기 정다각기둥형 수화젤과 치조골 사이의 접촉면적을 나타낸 그래프(도 7)가 제시되어 있다.6 and 7 are schematic diagrams showing cross sections of a conventional cylindrical cylindrical hydrogel and a regular polygon pillar hydrogel, which is an embodiment of the present invention, respectively (FIG. 6) and a contact area between the regular polygon hydrogel and the alveolar bone. A graph (FIG. 7) is shown.
형태shape 둥근 실린더형(cylinder)Round cylinder 정삼각기둥(regular triangle)Regular triangle 정사각기둥(regular square)Regular square 정오각기둥(regular pentagon)Regular pentagon 정육각기둥(regular hexagon)Regular hexagon 정팔각기둥(regular octagon)Regular octagon 정구각기둥(regular nonagon)Regular nonagon 정십각기둥(regular decagon)Regular decagon
높이(cm)Height (cm) 1.51.5 1.51.5 1.51.5 1.51.5 1.51.5 1.51.5 1.51.5 1.51.5
부피(ml)Volume (ml) 0.420.42 0.420.42 0.420.42 0.420.42 0.420.42 0.420.42 0.420.42 0.420.42
단면적(cm2)Cross section area (cm 2 ) 0.280.28 0.280.28 0.280.28 0.280.28 0.280.28 0.280.28 0.280.28 0.280.28
한변의 길이(cm)Length of one side (cm) -- 0.800.80 0.530.53 0.410.41 0.330.33 0.240.24 0.210.21 0.190.19
치조골과의 접촉면적(cm2)Area of contact with alveolar bone (cm 2 ) -- 1.211.21 0.790.79 0.610.61 0.490.49 0.360.36 0.320.32 0.290.29
상기 표 1은 1.5 ㎝ 높이 및 0.42 ㎖ 부피가 고정된 둥근 실린더형과 정다각형 수화젤에 따른 한변의 길이와 치조골과의 접촉면적을 나타낸 것으로, 도 7과 상기 표 1을 참조하면, 부피가 0.42 ㎖로 고정된 정다각기둥형 수화젤의 단면이 정삼각형일 때, 수화젤과 치조골 사이의 접촉면적이 가장 넓고, 점점 각의 개수가 증가함에 따라서, 상기 접촉면적이 좁아지는 것을 볼 수 있다. 상기 접촉면적은 바람직하게는 0.35 내지 1.5 ㎠ 이다. Table 1 shows the length of one side and the contact area between the alveolar bone according to the round cylindrical and regular polygonal hydrogels fixed with a height of 1.5 cm and 0.42 ml. Referring to FIG. 7 and Table 1, the volume is 0.42 ml. When the cross section of the fixed polygonal hydrogel is fixed to an equilateral triangle, the contact area between the hydrogel and the alveolar bone is the widest, and as the number of angles increases, the contact area becomes narrower. The contact area is preferably 0.35 to 1.5 cm 2.
접촉면적이 1.5 ㎠를 초과하면, 그에 따라 수화젤의 초기 부피 또한 커져 시술시 절개 부위가 커지고, 접촉면적이 0.35 ㎠ 미만이면, 치주골과의 안착률이 낮아 시술의 편의성이 떨어지게 된다.If the contact area exceeds 1.5 cm 2, accordingly, the initial volume of the hydrogel is also increased to increase the incision site during the procedure, and if the contact area is less than 0.35 cm 2, the rate of settlement with the periodontal bone is low, thereby reducing the convenience of the procedure.
따라서, 정다각기둥형 수화젤은 각기둥면으로 인하여 종래의 둥근 실린더형 수화젤에 비하여 치조골과의 접촉면적이 넓어지면서 안착률이 높아지고, 삽입 후에 치은 내부에서 움직임이 미미하여 시술의 편의성이 증가한다.Therefore, the regular polygonal hydrogel is wider in contact area with the alveolar bone due to the prismatic surface, and the seating rate is increased, and the movement of the gingiva inside the gingiva is minimal, and the convenience of the procedure is increased.
[실험예2] 수화젤 제조 Experimental Example 2 Preparation of Hydrogel
가교결합된 메틸 메타크릴레이트(MMA)와 비닐-피롤리돈(VP)이 6~7 : 4~3 의 질량비를 갖도록, 메틸 메타크릴레이트(MMA), 비닐-피롤리돈(VP), 2,2'-아조비스이소부틸로니트릴(중합 개시제) 0.1 wt%, 히드록시프로필 메타크릴레이트(가교제) 0.2 wt%, 및 메틸피롤리돈(용매)를 배합하여 전체 용액의 농도가 0.8 M이 되도록 배합한 후, 상기 배합물을 24 시간 동안 65 ℃의 온도로 열 중합시켰다. 이후 용매 등의 잔유물을 제거하고 가수분해하여 메틸 메타크릴레이트(MMA)와 비닐-피롤리돈(VP)이 가교결합된 수화젤을 부피가 서로 다른 0.15, 0.25 및 0.42 ml의 둥근 실린더형 몰드에 부어 비교예 1 내지 3을 제조하였다. Methyl methacrylate (MMA), vinyl-pyrrolidone (VP), 2, such that crosslinked methyl methacrylate (MMA) and vinyl-pyrrolidone (VP) have a mass ratio of 6-7: 4-3 0.1 wt% of 2'-azobisisobutylonitrile (polymerization initiator), 0.2 wt% of hydroxypropyl methacrylate (crosslinking agent), and methylpyrrolidone (solvent) were combined to give a total solution concentration of 0.8 M. After blending, the blend was thermally polymerized to a temperature of 65 ° C. for 24 hours. Subsequently, the residues such as solvents were removed and hydrolyzed to prepare hydrogels crosslinked with methyl methacrylate (MMA) and vinyl-pyrrolidone (VP) in 0.15, 0.25 and 0.42 ml round cylindrical molds having different volumes. Pour Comparative Examples 1 to 3 were prepared.
상기 비교예1 내지 3과 동일한 방법으로 제조된 수화젤을 사각기둥형 압축몰드에 넣고, 평균 8 ㎫ 압력과 평균 60 ℃ 온도를 가하여 5시간 동안 압축건조하여 실시예 1 내지 3을 제조하였다. The hydrogels prepared in the same manner as in Comparative Examples 1 to 3 were placed in a square column-shaped compression mold, and compressed and dried for 5 hours by applying an average 8 MPa pressure and an average temperature of 60 ° C. to prepare Examples 1 to 3.
상기 비교예1 내지 3과 동일한 방법으로 제조된 수화젤을 타원기둥형 압축몰드에 넣고, 평균 8 ㎫ 압력과 평균 60 ℃ 온도를 가하여 5시간 동안 압축건조하여 실시예 4 내지 6을 제조하였다. The hydrogels prepared in the same manner as in Comparative Examples 1 to 3 were placed in an elliptic cylindrical compression mold, and compressed and dried for 5 hours by adding an average 8 MPa pressure and an average temperature of 60 ° C. to prepare Examples 4 to 6.
0.55 ㎖의 상기 메틸 메타크릴레이트(MMA)와 비닐-피롤리돈(VP)이 가교결합된 수화젤을 납작한 유선형 압축몰드에 넣고, 평균 8 ㎫ 압력과 평균 65 ℃온도를 가하여 5시간 동안 압축건조하여 실시예 7를 제조하였다.0.55 ml of the methyl methacrylate (MMA) and vinyl-pyrrolidone (VP) cross-linked hydrogels were put in a flat streamlined compression mold and subjected to compression drying for 5 hours by applying an average 8 MPa pressure and an average temperature of 65 ° C. Example 7 was prepared.
상기 실시예 1 내지 7와 비교예 1 내지 3을 37 ℃의 인큐베이터에서 생리식염수(saline)에 40일간 침지하여 팽윤시켰다.Examples 1 to 7 and Comparative Examples 1 to 3 were swelled by immersion in saline for 40 days in an incubator at 37 ° C.
[실험예3] 비교예와 실시예의 팽윤 전후 부피 비교 Experimental Example 3 Comparison of Volume Before and After Swelling of Comparative Example and Example
크기size 수화젤의 형태Form of hydrogel 팽윤 전 부피 (㎖)Volume before swelling (ml) 팽윤 후 부피 (㎖)Volume after swelling (ml) 팽창율(Q) Expansion rate (Q)
소형(small)Small 둥근 실린더형(비교예1)Round Cylinder (Comparative Example 1) 0.150.15 0.70.7 4.74.7
사각기둥형(실시예1)Square Column Type (Example 1) 0.10.1 0.70.7 77
타원기둥형(실시예4)Elliptic column type (Example 4) 0.10.1 0.70.7 77
중형(medium)Medium 둥근 실린더형(비교예2)Round Cylinder (Comparative Example 2) 0.250.25 1.31.3 5.25.2
사각기둥형(실시예2)Square Column Type (Example 2) 0.20.2 1.31.3 6.56.5
타원기둥형(실시예5)Elliptic column type (Example 5) 0.20.2 1.31.3 6.56.5
대형(large)Large 둥근 실린더형(비교예3)Round Cylinder (Comparative Example 3) 0.420.42 2.12.1 55
사각기둥형(실시예3)Square Column Type (Example 3) 0.370.37 2.12.1 5.75.7
타원기둥형(실시예6)Elliptic column type (Example 6) 0.370.37 2.12.1 5.75.7
유선형 (실시예7)Streamlined (Example 7) 0.050.05 0.50.5 1010
팽창율(Q) = (Swollen Volume of Hydrogel) / (Dry Volume of Hydrogel)Expansion rate (Q) = (Swollen Volume of Hydrogel) / (Dry Volume of Hydrogel)
도 8은 종래의 둥근 실린더형의 수화젤(도 8에서 a)인 비교예 1 내지 3과 본 발명의 실시예 1 내지 3에 따른 사각기둥형의 수화젤(도 8에서 b)의 팽윤 전후 부피를 비교한 그래프이고, 도 9는 종래의 둥근 실린더형의 수화젤(도 9에서 a)인 비교예 1 내지 3과 본 발명의 실시예 4 내지 6에 따른 타원기둥형 수화젤(도 9에서 c)의 팽윤 전후 부피를 비교한 그래프이다. 8 is a volume before and after swelling of the comparative examples 1 to 3 of the conventional round cylindrical hydrogel (a in FIG. 8) and the square pillar hydrogel (b in FIG. 8) according to Examples 1 to 3 of the present invention. 9 is a graph comparing the conventional round cylindrical hydrogels (a in FIG. 9), and Comparative Examples 1 to 3 and elliptic cylindrical hydrogels according to Examples 4 to 6 of the present invention (c in FIG. 9). ) Is a graph comparing the volume before and after swelling.
상기 도 8 및 도 9에 따르면, 본 발명의 수화젤은 가압 조건에서 건조하는 공정을 더 거치면서, 상기 수화젤의 부피가 종래의 치은 확장기의 수화젤의 부피보다 12 ~ 34 vol% 감소되었으나, 팽윤 후의 부피는 동일한 것을 확인할 수 있었다. 따라서, 실시예 1 내지 6은 비교예 1 내지 3보다 팽윤 전 부피가 작아, 시술시 절개 부위가 작아지게 되어 회복이 빨라지게 되고, 작은 부피로 인하여 치은 아래 삽입이 용이하게 된다.8 and 9, while the hydrogel of the present invention is further subjected to a drying process under pressure conditions, the volume of the hydrogel is reduced by 12 ~ 34 vol% than the volume of the hydrogel of the conventional gingival expander, The volume after swelling was confirmed to be the same. Therefore, Examples 1 to 6 have a smaller volume before swelling than Comparative Examples 1 to 3, so that the incision site becomes smaller during the procedure, so that the recovery is faster, and the small volume facilitates the insertion under the gingiva.
도 10은 종래의 둥근 실린더형의 수화젤(도 10에서 a)인 비교예 1 내지 3과 본 발명의 실시예 1 내지 3에 따른 사각기둥형 수화젤(도 10에서 b)의 최대 팽창율(Q)을 나타낸 그래프로서, 상기 비교예 1 내지 3의 최대팽창율(Q)의 평균값은 4.97이고, 상기 실시예 1 내지 3의 최대팽창율(Q)의 평균값은 6.4로 우수한 팽윤 특성이 있음을 확인할 수 있었다 10 is the maximum expansion rate (Q) of the conventional round cylindrical hydrogel (a in FIG. 10) of Comparative Examples 1 to 3 and the square column type hydrogel (b in FIG. 10) according to Examples 1 to 3 of the present invention. ), The average value of the maximum expansion rate (Q) of the Comparative Examples 1 to 3 is 4.97, the average value of the maximum expansion rate (Q) of the Examples 1 to 3 was 6.4 it was confirmed that the excellent swelling characteristics.
도 11은 종래의 둥근 실린더형의 수화젤(도 11에서 a)인 비교예 1 내지 3과 본 발명의 실시예 4 내지 6에 따른 타원기둥형 수화젤(도 11에서 c)의 최대 팽창율(Q)을 나타낸 그래프로서, 상기 비교예 1 내지 3의 최대팽창율(Q)의 평균값은 4.97이고, 상기 실시예 1 내지 3의 최대팽창율(Q)의 평균값은 6.4로 우수한 팽윤 특성이 있음을 확인할 수 있었다. 11 is the maximum expansion rate (Q) of the conventional round cylindrical hydrogel (a in FIG. 11) Comparative Examples 1 to 3 and the elliptic cylindrical hydrogel (c in FIG. 11) according to Examples 4 to 6 of the present invention ), The average value of the maximum expansion rate (Q) of the Comparative Examples 1 to 3 is 4.97, the average value of the maximum expansion rate (Q) of the Examples 1 to 3 was 6.4 it was confirmed that the excellent swelling characteristics. .
도 12는 종래의 둥근 실린더형의 수화젤(도 12에서 a)인 비교예 1과 본 발명의 실시예 7인 유선형 수화젤(도 12에서 d)의 팽윤 전후 부피를 비교한 그래프로, 비교예 1과 실시예 7의 팽윤 전 부피는 0.15 ㎖ 와 0.05 ㎖ 였으나, 팽윤 후 0.7 ㎖와 0.5 ㎖가 되었다. 12 is a graph comparing a volume before and after swelling of Comparative Example 1, which is a conventional round cylindrical hydrogel (a in FIG. 12) and a streamlined hydrogel (d in FIG. 12), which is a seventh embodiment of the present invention. The volume before swelling of 1 and Example 7 was 0.15 ml and 0.05 ml, but became 0.7 ml and 0.5 ml after swelling.
비교예 1과 실시예 7의 최대 팽창율을 비교해 보면, 4.7과 10으로 실시예 7의 최대 팽창율이 상당히 우수함을 알 수 있었다. 따라서, 본 발명의 유선형 수화젤은 팽윤 전 부피가 작고, 일측 또는 양측으로 갈수록 좁아지는 납작한 형태의 유선형를 하고 있어 시술시 삽입이 용이하고, 절개 부위가 작아져 회복이 빨라지는 장점이 있다.Comparing the maximum expansion rate of Comparative Example 1 and Example 7, it can be seen that the maximum expansion rate of Example 7 is significantly excellent in 4.7 and 10. Accordingly, the streamlined hydrogel of the present invention has a small volume before swelling, and has a flat streamline shape that narrows toward one side or both sides, so that it is easy to insert during the procedure, and the incision is small, so that the recovery is faster.
[실험예4] 비교예 1과 실시예 1의 팽윤 시간 비교 Experimental Example 4 Comparison of Swelling Time of Comparative Example 1 and Example 1
도 13에 제시된 바와 같이, 상기 비교예 1(도 13에서 a)의 팽윤 전 수화젤의 초기 부피는 0.15 ㎖이고, 실시예 1(도 13에서 b)의 팽윤 전 수화젤이 초기 부피는 0.1 ㎖였으나, 실리콘 홀을 통해 유입된 체액으로 점진적으로 팽윤되어, 팽윤 후 부피는 0.7 ㎖로 같아지고, 0.7 ㎖의 부피로 팽윤이 완료되기까지 비교예 1은 40일의 팽윤시간이 걸리고, 실시예 1은 27일의 팽윤 시간이 필요함을 확인할 수 있었다.As shown in FIG. 13, the initial volume of the hydrogel before swelling in Comparative Example 1 (a in FIG. 13) was 0.15 ml, and the initial volume of the hydrogel before swelling in Example 1 (b in FIG. 13) was 0.1 ml. Although gradually swelled with the body fluid introduced through the silicon hole, the volume after swelling is equal to 0.7 ml, Comparative Example 1 takes a swelling time of 40 days until swelling is completed in a volume of 0.7 ml, Example 1 It was confirmed that the need for 27 days of swelling time.
따라서, 본 발명의 실시예 1은 비교예 1에 비하여 짧은 팽윤시간을 갖는 장점이 있으며, 팽윤 전의 부피가 비교예 1에 비해 실시예 1이 더 작기 때문에 치은 아래에 삽입이 용이하여 시술 시 절개부위 감소와 편의성이 증가됨을 알 수 있었다.Therefore, Example 1 of the present invention has the advantage of having a short swelling time compared to Comparative Example 1, since the volume before the swelling Example 1 is smaller than Comparative Example 1 is easy to insert under the gingival incision during the procedure It was found that the decrease and convenience increased.
[실험예5] 실리콘 쉘의 홀의 크기와 두께 비교 Experimental Example 5 Comparison of Hole Size and Thickness in Silicon Shell
도 14는 200 ㎛ 두께의 실리콘 쉘 안에 상기 실시예 1의 수화젤을 넣고, 양측을 접합하고, 펀치를 사용하여 홀을 형성시켜 제조한 치은 확장기의 상기 홀 크기에 따른 팽윤 속도를 비교한 그래프로, 본 발명에서는 실리콘 쉘의 홀의 지름이 0.3 ~ 0.7 ㎜이 바람직하다. 이는 지름이 0.3 ㎜ 미만이면, 체액이 실리콘 쉘 내부로 들어가는 양이 적어 수화젤의 팽윤속도가 느려 원하는 기간(4주) 내에 최대 팽창 부피를 얻기가 힘들고, 상기 실리콘 쉘의 홀 지름이 0.7 ㎜를 초과하면, 체액이 실리콘 쉘 내부로 들어가는 양이 많아져 상기 수화젤의 급속한 팽윤을 가져오고, 이는 절개부에 강한 장력이 가해져 절개부의 치유에 악영향을 미칠 수도 있다.14 is a graph comparing the swelling speed according to the hole size of the gingival dilator prepared by putting the hydrogel of Example 1 in a 200 μm thick silicone shell, bonding both sides, and forming a hole using a punch. In the present invention, the diameter of the hole of the silicon shell is preferably 0.3 to 0.7 mm. If the diameter is less than 0.3 mm, the amount of body fluid entering the silicon shell is small and the swelling speed of the hydrogel is low, making it difficult to obtain a maximum expansion volume within a desired period (4 weeks), and the hole diameter of the silicon shell is 0.7 mm. If exceeded, the amount of body fluid entering the silicone shell increases, leading to rapid swelling of the hydrogel, which may exert strong tension on the incision and adversely affect the healing of the incision.
도 15는 실리콘 쉘 안에 상기 실시예 1의 수화젤을 넣고, 양측을 접합하고, 펀치를 사용하여 0.4 ㎜의 홀을 형성시켜 제조한 치은 확장기의 상기 실리콘 쉘 두께에 따른 팽윤 속도를 비교한 그래프를 나타낸 것으로서, 상기 실리콘 쉘이 두꺼워질수록 쉘에 둘러싸여있는 수화젤의 팽윤을 방해하는 힘이 커지기 때문에 팽윤 속도 역시 감소됨을 알 수 있다. 상기 실리콘 쉘의 두께는 바람직하게는 200 ~ 250 ㎛이다. 실리콘 쉘의 두께가 200 ㎛ 미만이면, 팽윤 속도가 증가하게 되는데. 상기 팽윤 속도가 적정이상 빨라지면 절개부에 강한 장력이 가해져 절개부의 치유에 악영향을 미치는 문제점이 존재한다. 또한, 실리콘 쉘의 두께가 250 ㎛ 초과하면, 팽윤 속도가 느려져 조직을 확장하는데 장시간이 소요된다. 15 is a graph comparing the swelling speed according to the thickness of the silicon shell of the gingival expander prepared by placing the hydrogel of Example 1 in the silicon shell, bonding both sides, and forming a hole of 0.4 mm using a punch. As shown, it can be seen that the thicker the silicone shell, the greater the force that hinders the swelling of the hydrogel surrounded by the shell, thereby decreasing the swelling rate. The thickness of the silicon shell is preferably 200 to 250 μm. If the thickness of the silicon shell is less than 200 μm, the swelling speed is increased. If the swelling speed is faster than appropriate, there is a problem that a strong tension is applied to the incision to adversely affect the healing of the incision. In addition, when the thickness of the silicon shell exceeds 250 µm, the swelling speed is slowed and it takes a long time to expand the tissue.
본 발명은 치과용 치은확장기에 관한 것으로서, 치조골 및 치은과의 접촉면적이 넓은 다각기둥형 또는 타원기둥형의 수화젤 또는 수화젤 일측의 폭이 좁은 부분을 이용하여 치은 내 삽입을 편하게 하는 유선형의 수화젤이, 양단부가 접합된 실리콘 쉘에 의해 둘러싸여진 구조를 갖는다. 이러한 본 발명의 치은 확장기는 시술의 편의성을 제공하고 원하는 부위의 조직을 확장시킬 수 있는 효과가 있어, 산업상 이용가능성이 있다.The present invention relates to a dental gingival expander, a streamlined type that facilitates insertion into the gingival using a narrow or partial portion of a hydrogel or hydrogel of a polygonal or elliptic column type having a wide contact area with the alveolar bone and gingiva. The hydrogel has a structure surrounded by a silicon shell bonded to both ends. The gingiva dilator of the present invention has the effect of providing the convenience of the procedure and expanding the tissue of the desired area, there is industrial applicability.

Claims (10)

  1. 체액을 흡수하여, 체내 팽윤을 통해 치은 내 공간을 확보하는 다각기둥형 또는 타원기둥형 수화젤;A polygonal columnar or elliptic columnar hydrogel that absorbs body fluid and secures a gingival space through swelling in the body;
    상기 수화젤을 둘러싸고, 양측이 접합된 접합부가 포함되는 실리콘 쉘; 및A silicon shell surrounding the hydration gel and including a joint portion joined to both sides; And
    상기 실리콘 쉘의 접합부와 치조골을 고정시키는 스크류;를 포함하는, 시술 편의성이 향상된 치과용 치은확장기.And a screw for fixing the joint and the alveolar bone of the silicone shell.
  2. 제1항에 있어서,The method of claim 1,
    상기 수화젤은 메타크릴레이트(Methacrylate)를 갖는 모노머와 비닐(vinyl)그룹을 갖는 모노머가 가교결합된 수화젤인, 시술 편의성이 향상된 치과용 치은확장기.The hydrogel is a hydrogel with a monomer having a methacrylate (metheth) and a monomer having a vinyl group (vinyl) cross-linked hydrogel, improved dental gingiva expander.
  3. 제1항에 있어서,The method of claim 1,
    상기 다각기둥형 수화젤의 단면은 변의 수가 3 내지 8인 정다각형인, 시술의 편의성이 향상된 치과용 치은확장기.Cross-section of the polygonal hydrogel gel is a regular polygon with the number of sides 3 to 8, dental gingival expandr with improved convenience of the procedure.
  4. 제3항에 있어서,The method of claim 3,
    상기 다각기둥형 수화젤의 치조골과의 접촉면적이 0.35 내지 1.5 ㎠ 인, 시술 편의성이 향상된 치과용 치은확장기.A dental gingival expander having improved ease of treatment, wherein the contact area with the alveolar bone of the polygonal hydrogel is 0.35 to 1.5 cm 2.
  5. 제1항에 있어서,The method of claim 1,
    상기 다각기둥형 수화젤의 단면은 다각형이고, The cross section of the polygonal hydrogel is polygonal,
    상기 다각형의 선대칭축의 길이가 상기 선대칭축을 기준으로 직각으로 만나는 직각장축보다 길거나 같은, 시술 편의성이 향상된 치과용 치은확장기.The length of the polygonal symmetry axis of the polygon is longer than or equal to the right longitudinal axis to meet at a right angle relative to the linear symmetry axis, dental gingival expandr with improved convenience.
  6. 제1항에 있어서, The method of claim 1,
    상기 타원기둥형 수화젤 단면의 종축과 상기 종축에 수직인 횡축의 비가 1이 아닌 것을 특징으로 하는, 시술 편의성이 향상된 치과용 치은확장기.The ratio of the longitudinal axis of the elliptic columnar hydrogel cross section and the horizontal axis perpendicular to the longitudinal axis is not 1, dental gingival device with improved procedure convenience.
  7. 체액을 흡수하여, 체내 팽윤을 통해 치은 내 공간을 확보하는 유선형의 수화젤;A streamlined hydrogel that absorbs body fluid and secures a gingival space through swelling in the body;
    상기 수화젤을 둘러싸고, 양측이 접합된 접합부가 포함되는 실리콘 쉘; 및A silicon shell surrounding the hydration gel and including a joint portion joined to both sides; And
    상기 실리콘 쉘의 접합부와 치조골을 고정시키는 스크류;를 포함하는, 시술 편의성이 향상된 치과용 치은확장기.And a screw for fixing the joint and the alveolar bone of the silicone shell.
  8. 제7항에 있어서,The method of claim 7, wherein
    상기 수화젤은 일측 또는 양측으로 갈수록 폭이 좁아지는 납작한 유선형인, 시술 편의성이 향상된 치과용 치은확장기.The hydration gel is a flat streamline that is narrower in width toward one side or both sides, the dental gingival expandr with improved convenience.
  9. 제1항 내지 제8항 중 어느 한 항에 있어서,The method according to any one of claims 1 to 8,
    상기 실리콘 쉘의 두께는 200 ~ 250 ㎛ 이고, 지름이 0.3 ~ 0.7 ㎜ 인 홀을 포함하는, 시술 편의성이 향상된 치과용 치은확장기.The thickness of the silicon shell is 200 ~ 250 ㎛, including a diameter of 0.3 ~ 0.7 ㎜, dental gingival dilator with improved convenience.
  10. 제1항 내지 제8항 중 어느 한 항에 있어서,The method according to any one of claims 1 to 8,
    상기 실리콘 쉘의 양측 접합부와 치조골이 상기 스크류를 이용하여 각각 고정되는, 시술 편의성이 향상된 치과용 치은확장기.Both sides of the joint and the alveolar bone of the silicone shell is fixed using the screw, the dental gingiva expander improved convenience.
PCT/KR2015/008754 2014-09-29 2015-08-21 Dental gingiva expander having improved operation convenience WO2016052860A1 (en)

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