WO2020175812A1 - 코팅층을 포함하는 안질환용 임플란트 - Google Patents

코팅층을 포함하는 안질환용 임플란트 Download PDF

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Publication number
WO2020175812A1
WO2020175812A1 PCT/KR2020/001653 KR2020001653W WO2020175812A1 WO 2020175812 A1 WO2020175812 A1 WO 2020175812A1 KR 2020001653 W KR2020001653 W KR 2020001653W WO 2020175812 A1 WO2020175812 A1 WO 2020175812A1
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WIPO (PCT)
Prior art keywords
tube
implant
eye
coating layer
area
Prior art date
Application number
PCT/KR2020/001653
Other languages
English (en)
French (fr)
Inventor
기창원
한종철
이연
강선아
박소현
백인수
Original Assignee
사회복지법인 삼성생명공익재단
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Application filed by 사회복지법인 삼성생명공익재단 filed Critical 사회복지법인 삼성생명공익재단
Priority to US17/434,277 priority Critical patent/US20220133953A1/en
Publication of WO2020175812A1 publication Critical patent/WO2020175812A1/ko

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/34—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
    • A61F2002/009—Special surfaces of prostheses, e.g. for improving ingrowth for hindering or preventing attachment of biological tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2420/00—Materials or methods for coatings medical devices
    • A61L2420/06—Coatings containing a mixture of two or more compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2420/00—Materials or methods for coatings medical devices
    • A61L2420/08—Coatings comprising two or more layers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/16—Materials or treatment for tissue regeneration for reconstruction of eye parts, e.g. intraocular lens, cornea

Definitions

  • the present invention relates to an implant for eye diseases for controlling intraocular pressure including a coating layer, and specifically to prevent fibrosis around the implant. It is about implants for eye diseases to control intraocular pressure that can be prevented.
  • Glaucoma is a disease in which the optic nerve is depressed due to an increase in intraocular pressure or a disorder in the blood supply, which causes an abnormality in the function of the optic nerve.
  • the optic nerve is a nerve that transmits light received by the eye to the brain and makes it visible. Defects appear, and vision is lost at the end.
  • the main cause of the onset of glaucoma is damage to the optic nerve due to an increase in intraocular pressure.
  • the intraocular pressure is mainly watertight (water produced in the eye, maintaining the shape of the eye and inside the eye). It is determined by the role of supplying nutrients).
  • Such glaucoma treatment methods include instillation or administration of an intraocular pressure-lowering agent, or glaucoma filtration, which helps circulation and discharge of water through a small hole in the iris through a laser. Treatment and filtration with such drugs fail or To prevent an increase in intraocular pressure after treatment and filtration, surgery is performed to insert an implant to maintain a certain level of intraocular pressure by adjusting the amount of intraocular water at the guide.
  • the technical task to be achieved by the present invention is intraocular pressure that can prevent foreign body reactions.
  • An exemplary embodiment of the present invention is the implant base material; and the outside of the implant base material.
  • An implant for eye disease for controlling intraocular pressure comprising a coating layer to be formed, wherein the coating layer is an acrylate-based monomer comprising two or more and six or less acrylate groups; And (meth)acryloyloxyethylphosphorylcholine monomer; It provides an implant for eye disease, which is a cured product of the polymer of the composition comprising a.
  • the implant for eye disease according to an exemplary embodiment of the present invention can prevent a reaction of foreign substances occurring around.
  • the implant for eye diseases can prevent proteins and cells from adsorbing and denatured in the implant.
  • FIG. 1 is a schematic diagram showing that an implant for eye diseases for controlling intraocular pressure including a coating layer is inserted into a guide.
  • FIG. 2 is a perspective view showing an example of an implant for eye diseases for controlling intraocular pressure including a coating layer.
  • FIG 3 is a cross-sectional view showing an example of an implant for eye disease for controlling intraocular pressure including a coating layer.
  • FIG. 4 is a perspective view showing another example of an implant for eye diseases for controlling intraocular pressure including a coating layer.
  • FIG. 5 is a cross-sectional view showing another example of an implant for eye diseases for controlling intraocular pressure including a coating layer.
  • FIG. 6 is a perspective view showing an implant for eye disease for controlling intraocular pressure including a coating layer with pores formed thereon.
  • FIG. 7 is a photograph taken with a camera of the conjunctiva of the right eye into which the implant of Example 1 was inserted and the left eye into which the implant of Comparative Example 1 was inserted, 2 weeks after the implant was inserted.
  • FIG. 8 is a diagram schematically showing a method of measuring the number of fibroblasts and the thickness of fibroblasts on an optical micrograph of an implant-inserted specimen of Example 1.
  • An exemplary embodiment of the present invention is an implant for eye diseases for controlling intraocular pressure including an implant base; and a coating layer formed on the outside of the implant base, wherein the coating layer includes 2 or more and 6 or less acrylate groups.
  • proteins and cells are prevented from adsorbing and denatured in the implant, thereby preventing side effects that may occur in patients with eye diseases, such as fibrosis, thrombus formation, inflammation, and tissue necrosis.
  • eye diseases may include glaucoma that occurs due to an increase in intraocular pressure, and such glaucoma includes congenital glaucoma, traumatic glaucoma, symptoms of glaucoma, hypertension, primary open right angle glaucoma, normal Intraocular pressure glaucoma, intraocular cystic glaucoma with caustic drop of the lens, chronic simple glaucoma, hypotonic glaucoma, pigmented glaucoma, primary closed right angle glaucoma, acute closed right angle glaucoma, chronic closed right angle glaucoma, intermittent closed right angle glaucoma, trauma of the eye It may include secondary glaucoma, glaucoma secondary to eye inflammation, drug secondary glaucoma, neovascular glaucoma, or secondary glaucoma caused by uveitis. Therefore, an implant according to one embodiment of the present invention may be an implant for glaucoma
  • the material of the implant base material is
  • the implant base material is polydimethylsiloxane (PDMS),
  • HA Hydroxyapatite
  • polylactic acid polylactic acid
  • PLA polyglycolic acid
  • PGA polyglycolic acid
  • PTFE Polytetrafluoroethylene
  • PET Polyethyleneterephthalate
  • Polypropylene Polypropylene
  • polyamides polyamides
  • the coating layer and the material of the implant base form a covalent bond, so that the implant according to an exemplary embodiment of the present invention may have excellent coating strength of the coating layer. .
  • compositions containing an acrylate monomer containing two or more and not more than six acrylate groups and a (meth)acryloyloxyethylphosphorylcholine monomer as a raw material for the coating layer, foreign substance reactions occurring in the surroundings are prevented. While suppressing, it is possible to provide an implant with excellent coating strength.
  • This acts as a crosslinking agent for an acrylate-based monomer containing two or more and six or less acrylate groups, and the (meth)acryloyloxyethylphosphorylcholine monomer and This is because it polymerizes. That is, containing the above 2 or more and 6 or less acrylate groups
  • the acrylate monomer is polymerized while being crosslinked like the (meth)acryloyloxyethylphosphorylcholine monomer and the net structure.
  • the polymerization may be initiated by a photoinitiator or a radical formed by thermal initiation.
  • the photoinitiator is benzophenone, benzoyl peroxide, azobisisobutyronitrile (AIBN), and
  • DMPA 2-dimethoxy-2-phenylacetophenone
  • the polymer of the composition containing the monomer may impart hydrophilicity to the coating.
  • the coating layer which is a cured product of the polymer, may have a contact angle of W O or more and 50 ⁇ or less.
  • the contact angle of the coating layer to water may be within the above range.
  • it can prevent proteins and cells from adsorbing to the implant, which can prevent fibrosis, thrombosis, inflammation and tissue necrosis, which are side effects that may occur in patients with eye diseases.
  • the polymer is photocured or thermally cured. It could be.
  • the acrylate-based monomer containing 2 or more and 6 or less acrylate groups is dipentaerythritol pentaacrylate, dipentaerythritol nucleus acrylate, ethylene glycol dimetha It may be one or more selected from acrylate and ethylene glycol diacrylate.
  • the acrylate monomer and (meth)acryloyloxyethylphosphorylcholine monomer are crosslinked in a network structure, and the implant according to one embodiment of the present invention
  • the coating layer of can have excellent coating strength.
  • the acrylate-based monomer comprising two or more and six or less acrylate groups is
  • the (meth)acryloyloxyethylphosphorylcholine monomer may be included in an amount of 1 part by weight or more and 5 parts by weight or less based on W0 parts by weight. 2020/175812 1»(:1 ⁇ 1 ⁇ 2020/001653
  • the implant according to one embodiment of the present invention is It can suppress the reaction of foreign substances that occur.
  • the coating layer of the implant is not more than 3 parts by weight and not more than 5 parts by weight, 2 parts by weight or more and 4 parts by weight or less.
  • the crosslinking between the acrylate-based monomer and the (meth)acryloyloxyethylphosphorylcholine monomer is sufficiently formed, so that the strength can be excellent, and the coating layer can be evenly coated on the outside of the implant base.
  • the thickness of the coating layer may be 100 11111 or more and 300 and 11 or less. Specifically, the thickness of the coating layer is 100 11111 or more and 250 11111 or less,
  • It may be 150 11111 or more 300 11111 or less, 150 11111 or more 250 11111 or less, 200 11111 or more 250 11111 or less. If the thickness of the coating layer is within the above range, a foreign body reaction that occurs around the implant when the implant is inserted into the guide ( Fibrosis) can be suppressed, as well as minimize the paint.
  • the implant base material is used to control intraocular pressure.
  • It may include a first tube through which the inner waterproofing water flows; and a second tube formed inside the first tube, wherein the second tube is disassembled in the guide according to the passage of a predetermined time after being inserted into the inner cavity. It can be formed of biodegradable materials.
  • the first tube and the second tube can be divided into a first area and a second area according to the distance from the front of the eyeball, and the second area of the first tube and the second tube is the first tube and the second tube.
  • the diameter may be wider and the structure may be expandable as the inner waterproofing water is introduced.
  • FIG. 1 is a schematic diagram showing that an implant for eye disease for controlling intraocular pressure including a coating layer is inserted into a guide according to an exemplary embodiment of the present invention.
  • the implant for eye diseases according to one embodiment of the present invention is the conjunctival tissue of the eye.
  • the tenon tissue 4 may be removed and inserted, and after the insertion, it may be placed on the guide by covering the conjunctival tissue or the tenon tissue 4 again.
  • the implant 100 for eye diseases is shown. When inserted, one side of the implant can be inserted anteriorly of the eyeball and one side of the opposite side can be inserted into the conjunctival tissue or tenon tissue (4).Through this, the anterior eye-repellent eye implant 100 is passed through the solution membrane tissue or Tenon organization (4) can be discharged.
  • Figure 3 is a cross-sectional view showing an example of the implant for eye diseases 100 for the control of the intraocular pressure according to the embodiment of the present invention.
  • the intraocular pressure is reduced by controlling the amount of douche of the generated eye waterproofing ⁇ 3 ⁇ 41160118 11111110]' 2020/175812 1»(:1 ⁇ 1 ⁇ 2020/001653
  • the implant 100 for eye diseases for controlling intraocular pressure is provided with water for the control of intraocular pressure.
  • the coating layer 30 is formed on the outside of the first tube 10
  • the second tube (20) is formed of a biodegradable material that is decomposed in the guide after a predetermined time passes after being inserted into the eye, and the first tube (10) and the second tube (20) are Depending on the distance from the first area (11,
  • the first region of the first tube (10) and the second tube (20) is the first region of the first tube (10) and the second tube (20) It has a wider diameter compared to that and may have an expandable structure as the inner waterproofing flows in.
  • the implant 100 for eye diseases may include a second tube 20 formed inside the first tube 10 on which the coating layer 30 is formed.
  • the tube 20 may be formed of a biodegradable material that is degraded in the guide according to a predetermined time course.
  • the biodegradable material may be collagen chitin ( ⁇ 1), but is not limited thereto. It can be decomposed, and even after decomposition, it may contain all biodegradable polymer substances that do not cause various diseases and have no side effects.
  • the second tube 20 can be formed so that the decomposition can be completely decomposed for a month, preferably, and not.
  • the second tube 20 can be formed so that the time it takes for the second tube 20 to be completely disassembled varies depending on the degree of disease, the condition of the eyeball, etc.
  • the implant is of the ocular waterproofing as time passes. You can control the amount of discharge, and you can control the intraocular pressure efficiently.
  • the second region 12 of the first tube 10 is similar to the second tube 20 described above.
  • the first region 11 of the first tube 10 is formed of a non-degradable material such as silicon
  • the second region 12 is made of a biodegradable material such as collagen and chitin.
  • the first region 11 and the second region 12 can be formed of different materials. This is in accordance with the purpose of effectively controlling intraocular pressure by controlling the discharge of intraocular water, and the first area (11) of the first tube (10) is formed of a material that does not decompose, a passage that supports the discharge of intraocular water continuously. If the second area 12 of the first tube 10 is formed of a biodegradable material like the second tube 20, the second area 12 and 22 are formed according to a predetermined time flow without any additional operation. ) Is decomposed, making it easier to control the waterproofing.
  • an area whose distance from the front of the eyeball is relatively close is connected to the first area (11, 21) and the first area (11, 21), and the area is relatively far from the front of the eyeball.
  • the second area 12 of the first tube 10 has the same purpose as described above. The point at which the necessity was no longer achieved after being achieved 2 2020/175812 1»(:1 ⁇ 1 ⁇ 2020/001653
  • the tube 20 When the tube 20 is completely disassembled, it can be removed in the same way as opening it with a syringe, etc. by a clinician, and after the second area 22 is removed, the first tube 10 is removed from the guide.
  • the intraocular pressure can be adjusted by allowing only zone 11 to discharge a certain amount of the aqueous humor.
  • FIG. 3 shows another cross-sectional view of the implant 100 for eye disease in the X-axis direction of FIG. 2. That is, referring to FIGS. 2 and 3), the first tube 10 and the second tube ( 20) The second regions 12 and 22 may have a wider diameter than the first regions 11 and 21 in the axial direction, and may have a structure capable of expanding in the axial direction as the inner waterproof water flows in. Therefore, the cross section of the first region (11, 21) of the first tube (10) and the second tube (20) according to one embodiment of the present invention may be circular, and the first tube (10) and the second tube (20) The cross section of the second area (12, 22) may be oval. For the cross section of the second area (12, 22) which can be formed in an elliptical shape as described above, the long diameter can be formed in the axial direction, and the short diameter is the ⁇ axis. Can be formed in any direction.
  • the thickness of the second regions 12 and 22 of the first tube 10 and the second tube 20 in order to facilitate expansion of the second regions 12 and 22 in the X-axis direction is 1 Compared to the regions 11 and 21, it can be formed relatively thinner.
  • the reason that the second regions 12 and 22 have an expandable structure is to control the pressure formed inside the tube by the inflow of the inner water, so it is suitable for this purpose.
  • the thickness of the second areas 12 and 22 is relatively thick compared to the first areas 11 and 21 formed with a predetermined thickness so that the inner waterproofing water can be fixed and flow in order to expand the second areas 12 and 22. It can be formed thin.
  • the first area 11 of the first tube 10 is
  • a hole may be formed at the contact point where the area 12 meets, and a medical room, etc., can be connected through the hole so that the implant for eye disease 100 can be easily fixed in the guide, i.e., the implant for eye disease 100 is guided.
  • the hole formed at the contact point where the first area 11 and the second area 12 meet by a clinician etc. is connected to the tissue of the guide through a medical room, etc. (100) It is possible to prevent problems such as movement or shaking from the inserted area to another area due to the internal waterproof pressure or the fiber structure of the guide.
  • one surface of the eye disease implant 100 may be formed in a shape similar to that of the eyeball.
  • one surface of the eye disease implant 100 is referred to as eye disease. It refers to the part that is placed in the vitreous direction of the eyeball when the implant 100 is inserted into the guide. If this one side is formed in a shape similar to the curved surface of the eyeball, the implant 100 can be more stably fixed in the guide.
  • the inner waterproof water is introduced into the first areas 11 and 21 and discharged through the second areas 12 and 22, and the pressure of the incoming inner waterproofing water is used.
  • the diameter of the second regions 12 and 22 can be made wider than that of the first regions 11 and 21 in order to effectively discharge the eye water.
  • the first region 11 of the first tube 10 has The diameter () may be 100 or more, and the diameter () of the first region 21 of the second tube 20 is 2020/175812 1»(:1 ⁇ 1 ⁇ 2020/001653
  • the diameter 0 0 of the first region 21 of the second tube 20 before decomposition can be formed to have a diameter of 45 / /.
  • the diameter of the second region (12, 22) may be wider than that of the first region (11, 21), so the diameter () of the second region (22) of the second tube (20) is the subject of the first tube (10). It can be wider than the diameter () of 1 area (11).
  • the inlet port of 21) may have the same diameter or may be wider. In other words, the diameter of the outlet port ultimately determines the flow rate of the intraocular water discharged through the eye disease implant 100, depending on the degree of eye disease and the condition of the eye.
  • the diameter of the outlet of the second zone (12, 22) of the first tube (10) and the second tube (20) is equal to or wider than the diameter of the inlet of the first zone (11, 21) in order to control the discharge rate and discharge of the waterproof water. Can be selectively formed to
  • the lengths of the first areas 11 and 21 of the first tube 10 and the second tube 20 may be 7 _ or more and less than or equal to 7 _, that is, as described above, the second area ( 12) After this is removed by clinical, etc., the eye must be discharged from the front of the eye to the conjunctival tissue or tenon tissue through only the first area (11).
  • the first areas 11 and 21 may be formed to have a length in the above-described range.
  • Figure 4 is for eye diseases for the control of intraocular pressure according to one embodiment of the present invention
  • FIG. 1 It is a perspective view showing another example of the implant 100
  • Figure 5 is a cross-sectional view showing another example of the implant 100 for eye diseases for the control of intraocular pressure according to an exemplary embodiment of the present invention.
  • the second tube 20 according to an exemplary embodiment of the present invention is connected to the second region 22 of the second tube 20, the first of the second tube 20 Area 21 and
  • the rear protective tube 13 of the first tube 10 is blocked or damaged by the rear tube 23 of the second tube 20 due to the fiber structure. It can be formed in the form of wrapping the rear tube (23) from the outside to prevent the case.
  • the rear protection tube 13 is formed to be connected to the second area 12 of the first tube 10, and is intended to protect the rear tube 23 from the fibrous structure, so that the second area 12 of the first tube 10 is
  • the rear protective tube 13 and the rear tube 23 have the second tube 20, like the second area 12, 22 of the first tube 10 and the second tube 20. At the point of complete disintegration, it can be removed in the same way as opening it with an injection needle, etc. by a clinical back.
  • the rear protective tube (13) and the rear tube (23) are biodegradable as described above. When it is formed of a sexual substance, it is naturally decomposed over a predetermined period of time, and the hydraulic pressure and discharge amount of the inner water can be easily adjusted.
  • FIG. 6 is a perspective view showing an implant for eye diseases 100 for controlling intraocular pressure in which pores 0 ⁇ ) 40 are formed according to an exemplary embodiment of the present invention.
  • the pore 40 for fixing the implant 100 may be formed, i.e., when the pore 40 is formed in the second region 12 of the first tube 10, the implant for eye disease 100 is guided.
  • the fibrous tissue of the eyeball that has grown over time after being inserted into the eyeball flows into the pore 40 to fix the implant for eye disease 100.
  • the pore 40 is formed in the second tube 20 Since the fibrous tissue is introduced into the tube to prevent the movement of the inner waterproof, the pore 40 is preferably formed in the first tube 10, but may also be formed in the second tube 20 depending on the purpose.
  • the pores on the rear protection tube 13 ( 40) is preferably formed, but is not limited thereto.
  • [6 is 3*3*0.4 111111 sized implant base (material: polydimethylsiloxane or
  • a composition containing 0 parts by weight of methacryloyloxyethylphosphorylcholine monomer and benzophenone as a photoinitiator was prepared.
  • an implant base material material: polydimethylsiloxane or polytetrafluoroethylene
  • an implant base material material: polydimethylsiloxane or polytetrafluoroethylene
  • Example 1 The implant of Example 1 was inserted into the right eye of 12 New Zealand white rabbits having a weight of 1.5 kg to 2.0 kg, and the implant of Comparative Example 1 was inserted into the left eye.
  • FIG. 7 shows the right eye into which the implant of Example 1 was inserted and a comparison. This is a picture of the conjunctiva of the left eye in which the implant was inserted in Example 1 was taken with a camera two weeks after the implant was inserted.
  • the eyeball was cut into 5 [ mi-sized sagittal sections with a microincision, and then put on a gelatin-painted slide to make a specimen. After removing the wax, rehydration was performed, and H & E (Hematoxylin & Eosin) staining was performed.
  • FIG. 8 is a diagram schematically showing the method of measuring the number of fibroblasts and the thickness of the fibroblasts on an optical micrograph of the implanted specimen of Example 1. Specifically, in the part where fibrosis was observed (the square part in Fig. 8(a)) the middle conjunctival part 3 part and the sclera part 3 part (the square part in Fig. 8(b)), each randomly square part of size 100 X 100 (Fig. Of 8(c) 2020/175812 1»(:1 ⁇ 1 ⁇ 2020/001653
  • the number of cells observed in the square was immediately determined by selecting two areas).
  • the thickness of the fibrotic membrane was measured at an arbitrary point near the square.
  • Table 1 shows the average values of the cell number and fibrotic membrane thickness in the three conjunctival and scleral regions.
  • the implant for eye diseases is an acrylate monomer containing 2 or more and 6 or less acrylate groups on the outside of the implant base; And (meth)acryloyloxyethylphosph
  • a coating layer which is a cured product of a polymer of a composition containing a porylcholine monomer; it can be seen that cells and proteins can be prevented from adsorbing and denatured, thereby preventing foreign body reactions such as fibrosis, thrombosis, inflammation, and tissue necrosis. there was.
  • Retina of the eye 4 Conjunctival tissue or tenon tissue of the eye

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Abstract

[요약] 본 발명은 임플란트 기재의 외부에 형성되는 코팅층을 포함하는 안압 조절을 위한 안질환용 임플란트에 관한 것이다. 본 발명은 구체적으로 임플란트 기재의 외부에 형성되는 아크릴레이트계 단량체 및 (메트)아크릴로일옥시에틸포스포릴콜린 단량체를 포함하는 조성물의 중합물의 경화물인 코팅층을 포함하여 임플란트 주변에서 발생하는 이물 반응을 억제시킬 수 있는 임플란트에 관한 것이다. [대표도] 도 1

Description

2020/175812 1»（：1/10公020/001653 명세서
발명의 명칭:코팅층을포함하는안질환용임플란트 기술분야
[1] 본명세서는 2019년 02월 27일에한국특허청에제출된한국특허출원
제 10-2019-0023214호의출원일의이익을주장하며,그내용전부는본발명에 포함된다.본발명은코팅층을포함하는안압조절을위한안질환용임플란트에 관한것으로,구체적으로임플란트주변의섬유화를방지할수있는안압조절을 위한안질환용임플란트에관한것이다.
배경기술
[2] 녹내장은안압의상승으로인해시신경이눌리거나혈액공급에장애가생겨 시신경의기능에이상을초래하는질환이다.시신경은눈으로받아들인빛을 뇌로전달하여보게하는신경이므로여기에장애가생기면시야결손이 나타나고,말기에는시력을상실하게된다.녹내장의발병의주요원인은안압 상승으로인한시신경의손상이다.안압은주로안방수（눈안에서만들어지는 물을말하며,눈의형태를유지하고눈내부에영양분을공급하는역할을 담당한다）에의해결정된다.
[3] 이러한녹내장의치료방법에는안압하강제를점안또는복용하거나,레이저를 통해홍채에작은구멍을뚫어안방수의순환및배출을돕는녹내장여과술 등이 있는데,이러한약물치료및여과술이실패하거나약물치료및여과술 이후안압의상승을예방하기위해안내에안방수의양을조절하여안압을일정 수준유지하기위한임플란트를삽입하는수술을진행한다.
[4] 그러나,수술이잘시행된경우에도임플란트주변에서이물반응으로주변 조직이딱딱하게굳어지는섬유화가발생하여결국안압이다시조절되지않는 경우가있다.따라서안질환용임플란트에있어서,이물반응을억제하고 최소화하는것은가장중요한숙제라고할수있다.
[5] 그러므로,안질환용임플란트의기계적물성을유지하면서이물반응즉,체내 단백질이흡착및변성되는것을방지할수있는안질환용임플란트가필요한 실정이다.
발명의상세한설명
기술적과제
[6] 본발명이이루고자하는기술적과제는이물반응을방지할수있는안압
조절을위한안질환용임플란트를제공하는것이다.
[7] 다만,본발명이해결하고자하는과제는상기언급한과제로제한되지않으며 , 언급되지않은또다른과제들은하기의기재로부터당업자에게명확하게 이해될수있을것이다.
과제해결수단 2020/175812 1»（：1^1{2020/001653
2
[8] 본발명의일실시상태는임플란트기재;및상기임플란트기재의외부에
형성되는코팅층을포함하는안압조절을위한안질환용임플란트로서 ,상기 코팅층은 2개이상 6개이하의아크릴레이트기를포함하는아크릴레이트계 단량체;및（메트）아크릴로일옥시에틸포스포릴콜린단량체;를포함하는 조성물의중합물의경화물인안질환용임플란트를제공한다.
발명의효과
[9] 본발명의일실시상태에따른안질환용임플란트는주변에서발생하는이물 반응을방지할수있다.
[1이 구체적으로,본발명의일실시상태에따른안질환용임플란트는임플란트에 단백질및세포가흡착되고변성되는것을방지할수있다.
도면의간단한설명
[11] 도 1은코팅층을포함하는안압의조절을위한안질환용임플란트가안내에 삽입된것을나타낸모식도이다.
[12] 도 2는코팅층을포함하는안압의조절을위한안질환용임플란트의일예를 나타낸투시도이다.
[13] 도 3은코팅층을포함하는안압의조절을위한안질환용임플란트의일예를 나타낸단면도이다.
[14] 도 4는코팅층을포함하는안압의조절을위한안질환용임플란트의또다른일 예를나타낸투시도이다.
[15] 도 5는코팅층을포함하는안압의조절을위한안질환용임플란트의또다른일 예를나타낸단면도이다.
[16] 도 6은포어 가형성된코팅층을포함하는안압의조절을위한안질환용 임플란트를나타낸사시도이다.
[17] 도 7은실시예 1의임플란트가삽입된우안및비교예 1의임플란트가삽입된 좌안의결막을임플란트삽입한날로부터 2주후에카메라로찍은사진이다.
[18] 도 8은실시예 1의임플란트가삽입된표본의광학현미경사진에섬유아세포의 수와섬유화막두께의측정방법을개략적으로나타낸도면이다.
발명의실시를위한최선의형태
[19] 본발명에서사용되는용어는본발명에서의기능을고려하면서가능한현재 널리사용되는일반적인용어들을선택하였으나,이는당분야에종사하는 기술자의의도또는판례,새로운기술의출현등에따라달라질수있다.또한, 특정한경우는출원인이임의로선정한용어도있으며,이경우해당되는발명의 설명부분에서상세히그의미를기재할것이다.따라서본발명에서사용되는 용어는단순한용어의명칭이아닌,그용어가가지는의미와본발명의전반에 걸친내용을토대로정의되어야한다.
[2이 본명세서에 있어서,어떤부분이어떤구성요소를 "포함”한다고할때,이는 특별히반대되는기재가없는한다른구성요소를제외하는것이아니라다른 구성요소를더포함할수있는것을의미한다.
[21] 본명세서에 있어서,”...부”,”모듈”등의용어는적어도하나의기능이나
동작을처리하는단위를의미하며 ,이는하드웨어또는소프트웨어로
구현되거나하드웨어와소프트웨어의결합으로구현될수있다.
[22] 본명세서에 있어서,본발명을명확하게설명하기위하여도면에서설명과 관계없는부분은생략하였으며,명세서전체를통하여유사한부분에대해서는 유사한도면부호를붙였다.
[23]
[24] 이하,본발명에대하여더욱상세하게설명한다.
[25]
[26] 본발명의일실시상태는임플란트기재 ;및상기임플란트기재의외부에 형성되는코팅층을포함하는안압조절을위한안질환용임플란트로서 ,상기 코팅층은 2개이상 6개이하의아크릴레이트기를포함하는아크릴레이트계 단량체 ;및 (메트)아크릴로일옥시에틸포스포릴콜린단량체 ;를포함하는 조성물의중합물의경화물인안질환용임플란트를제공한다.
[27] 본발명의일실시상태에따른임플란트를안내에삽입하는경우생체
적합성이높아임플란트주변에서발생하는이물반응을방지할수있다.
구체적으로,단백질및세포가임플란트에흡착되고변성되는것을방지하여, 안질환환자에게발생할수있는부작용,예를들어,섬유화,혈전형성,염증, 조직괴사등을방지할수있다.
[28] 본발명의일실시상태에따르면,안질환에는안압상승으로인해발생하는 녹내장등이포함될수있으며,이러한녹내장에는선천성녹내장,외상성 녹내장,녹내장의증,고안압증,원발성개방우각녹내장,정상안압녹내장, 수정체의가성낙설을동반한수정체낭성녹내장,만성단순녹내장,저안압 녹내장,색소성녹내장,원발성폐쇄우각녹내장,급성폐쇄우각녹내장,만성 폐쇄우각녹내장,간헐성폐쇄우각녹내장,눈의외상에속발된녹내장,눈의 염증에속발된녹내장,약물에속발된녹내장,신생혈관녹내장또는포도막염에 의한이차녹내장등이포함될수있다.따라서,본발명의일실시상태에따른 임플란트는녹내장용임플란트일수있다.
[29] 본발명의일실시상태에따르면,임플란트기재의소재는상기조성물에
포함되는 (메트)아크릴로일옥시에틸포스포릴콜린단량체의아크릴레이트기의 C=C결합과반응하여공유결합을형성할수있는라디칼을제공할수있는 작용기를포함하는물질일수있다.예를들어,상기임플란트기재의소재는 를리디메틸실록산 (polydimethylsiloxane; PDMS)계 ,
하이드록시아파타이트 (hydroxyapatite; HA)계 ,쓸리락트산 (polylactic acid;
PLA)계 ,폴리글리콜산 (polyglycolic acid; PGA)계 ,
쓸리테트라늘루오로에틸렌 (polytetrafluoroethylene; PTFE)계 ,
쓸리에틸렌테레프탈레이트 (polyethyleneterephthalate; PET)계 , 쓸리프로필렌 (polypropylene)계 ,쓸리아미드 (polyamides)계 ,
를리아세탈 (polyacetal)계 ,쓸리에스테르 (polyester)계및
쓸리메틸메타크릴레이트 (polymethyl metacrylate)계중에서선택된 1종이상일수 있다.이경우,코팅층과임플란트기재의소재가공유결합을형성하여본 발명의일실시상태에따른임플란트는코팅층의코팅강도가우수할수있다.
[3이 본발명의일실시상태에따르면,상기임플란트기재의외부에형성되는
코팅층의원료로상기 2개이상 6개이하의아크릴레이트기를포함하는 아크릴레이트계단량체와 (메트)아크릴로일옥시에틸포스포릴콜린단량체를 동시에포함하는조성물을이용함으로써주변에서발생하는이물반응을 억제하면서코팅강도가우수한임플란트를제공할수있다.이는상기 2개이상 6개이하의아크릴레이트기를포함하는아크릴레이트계단량체가가교제로 작용하여,상기 (메타)아크릴로일옥시에틸포스포릴콜린단량체와중합하기 때문이다.즉,상기 2개이상 6개이하의아크릴레이트기를포함하는
아크릴레이트계단량체는상기 (메타)아크릴로일옥시에틸포스포릴콜린 단량체와그물구조와같이가교되면서중합된다.상기중합은광개시제또는 열개시에에의하여형성되는라디칼에의하여개시 (initiation)될수있다.상기 광개시제는벤조페논 (benzophenone),벤조일퍼옥사이드 (benzoyl peroxide), 아조비스이소부티로니트릴 (azobisisobutyronitrile, AIBN)및
2, 2 -디메톡시 -2 -페닐아세토페논 (2,2-dimethoxy-2-phenylacetophenone, DMPA) 중에서선택된 1종이상일수있다.다만,이에한정되는것은아니다.
[31] 상기아크릴레이트계단량체및 (메타)아크릴로일옥시에틸포스포릴콜린
단량체를포함하는조성물의중합물은코팅증에친수성을부여할수있다.이에 따라,상기중합물의경화물인코팅층은물에대한접촉각이 W O이상 50ᄋ 이하일수있다.상기코팅층의물에대한접촉각이상기범위내인경우,단백질 및세포가임플란트에흡착되는것을방지하여,안질환환자에게발생할수있는 부작용인섬유화,혈전형성,염증및조직괴사를방지할수있다.한편,상기 코팅층은상기중합물이광경화또는열경화된것일수있다.
[32] 본발명의일실시상태에따르면,상기 2개이상 6개이하의아크릴레이트기를 포함하는아크릴레이트계단량체는디펜타에리트리톨펜타아크릴레이트, 디펜타에리트리톨핵사아크릴레이트,에틸렌글리콜디메타크릴레이트및 에틸렌글리콜디아크릴레이트중에서선택된 1종이상일수있다.이경우, 아크릴레이트계단량체및 (메타)아크릴로일옥시에틸포스포릴콜린단량체가 그물구조로가교되어본발명의일실시상태에따른임플란트의코팅층은코팅 강도가우수할수있다.
[33] 본발명의일실시상태에따르면,상기 2개이상 6개이하의아크릴레이트기를 포함하는아크릴레이트계단량체는상기
(메트)아크릴로일옥시에틸포스포릴콜린단량체 W0중량부에대하여 1중량부 이상 5중량부이하의함량으로포함될수있다.구체적으로상기 2020/175812 1»（：1^1{2020/001653
5 아크릴레이트계단량체의함량음상기 (메트)아크릴로일옥시에틸포스포릴콜린 단량체 100중량부에대하여, 1중량부이상 4중량부이하, 1중량부이상 3 중량부이하, 2중량부이상 5중량부이하, 3중량부이상 5중량부이하, 2 중량부이상 4중량부이하일수있다.상기아크릴레이트계단량체의함량이 상기범위내인경우,본발명의일실시상태에따른임플란트는주변에서 발생하는이물반응을억제할수있다.또한,임플란트의코팅층은
아크릴레이트계단량체와 (메타)아크릴로일옥시에틸포스포릴콜린단량체의 가교가충분히형성되어강도가우수할수있다.그리고,임플란트기재의 외부에상기코팅층이고르게코팅될수있다.
[34] 본발명의일실시상태에따르면,상기코팅층은두께가 100 11111이상 300며11 이하일수있다.구체적으로,상기코팅층의두께는 100 11111이상 250 11111이하,
150 11111이상 300 11111이하, 150 11111이상 250 11111이하, 200 11111이상 250 11111이하일 수있다.상기코팅층의두께가상기범위내인경우,임플란트를안내에 삽입하였을때임플란트주변에서발생하는이물반응 (섬유화)을억제할수있을 뿐만아니라이물감을최소화할수있다.
[35] 본발명의일실시상태에따르면,상기임플란트기재는안압조절을위해
안방수가유입되는제 1튜브;및상기제 1튜브의내부에형성되는제 2튜브;를 포함할수있고,상기제 2튜브는안 句내부로삽입된이후소정의시간이 흐름에따라안내에서분해되는생분해성물질로형성될수있다.또한,상기제
1튜브및제 2튜브는안구의전방 으로부터의거리에따라제 1 영역및제 2영역으로구분가능할수있고,상기제 1튜브및제 2튜브의제 2 영역은상기제 1튜브및제 2튜브의제 1영역에비해직경이넓고상기 안방수가유입됨에따라팽창가능한구조일수있다.
[36] 도 1은본발명의일실시상태에따른코팅층을포함하는안압의조절을위한 안질환용임플란트가안내에삽입된것을나타낸모식도이다.
[37] 본발명의일실시상태에따른안질환용임플란트 (100)는안구의결막조직
또는테논조직 (4)을박리시켜삽입될수있으며,삽입된이후에는다시결막조직 또는테논조직 (4)을덮는방식으로안내에배치될수있다.도 1을참조하면, 안질환용임플란트 (100)가삽입될시,임플란트의일측이안구의전방에 삽입되고반대편일측이결막조직또는테논조직 (4)에삽입될수있으며,이를 통해전방에서생성되는안방수가안질환용임플란트 (100)를통해결막조직 또는테논조직 (4)으로배출될수있도록할수있다.
[38] 도 2는본발명의일실시상태에따른안압의조절을위한안질환용
임플란트 (100)의일예를나타낸투시도이며,도 3은본발명의일실시상태에 따른안압의조절을위한안질환용임플란트 (100)의일예를나타낸단면도이다.
[39] 본발명의일실시상태에따른안질환용임플란트 (100)는안질환으로인해
안압이상승하여시신경이손상되는것을막기위하여안구의
Figure imgf000007_0001
Figure imgf000007_0002
생성되는안방수 ＜¾1160118 11111110]')의배줄량을조절하여안압을 2020/175812 1»（：1^1{2020/001653
6 조절하는튜브형태의 임플란트를의미할수있다.도 2및도 3을참조하면,본 발명의 일실시상태에 따른안압의조절을위한안질환용임플란트 (100)는, 안압의조절을위해 안방수가유입되는제 1튜브 (10)및제 1튜브 (10)의 내부에 형성되는제 2튜브 (20)를포함하고,제 1튜브 (10)의외부에상기코팅층 (30)이 형성되며,제 2튜브 (20)는안 句내부로삽입된이후소정의시간이흐름에 따라안내에서분해되는생분해성물질로형성되고,제 1튜브 (10)및제 2 튜브 (20)는안구의
Figure imgf000008_0001
부터의 거리에따라제 1영역 (11,
21)및제 2영역 (12, 22)으로구분가능하고,제 1튜브 (10)및제 2튜브 (20)의제 2 영역 (12, 22)은제 1튜브 (10)및제 2튜브 (20)의제 1영역에 비해직경이 넓고 안방수가유입됨에따라팽창가능한구조일수있다.
[4이 본발명의 일실시상태에 따른안질환용임플란트 (100)는외부에코팅층 (30)이 형성된제 1튜브 (10)의 내부에 형성된제 2튜브 (20)를포함할수있다.상기 제 2 튜브 (20)는소정의시간흐름에 따라안내에서분해되는생분해성물질로형성될 수있다.이 때,생분해성물질은콜라겐 키틴 (油他 1)등일수있으며, 이에 한정되지 않고생체내에서분해될수있으며분해가된이후에도각종 질병을일으키지 않고부작용이 없는생분해성고분자물질등을모두포함할수 있다.또한,제 2튜브 (20)는바람직하게는한달동안완전히분해가이루어질수 있도록형성될수있으며,안질환의정도,안구의상태등에 따라제 2튜브 (20)가 완전히분해되는데까지걸리는시간이달라지도록제 2튜브 (20)를형성할수 있다.이 경우,상기 임플란트는시간이흐름에 따라안방수의 배출량을조절할 수있고,효율적으로안압을조절할수있다.
[41] 또한,제 1튜브 (10)의 제 2영역 (12)은전술한제 2튜브 (20)와마찬가지로
소정의시간의흐름에 따라안내에서분해되는생분해성물질로형성될수있다. 즉,제 1튜브 (10)의제 1영역 (11)은실리콘등과같이분해되지 않는물질로 형성되고,제 2영역 (12)은콜라겐,키틴등과같은생분해성물질로
형성됨으로써 제 1영역 (11)과제 2영역 (12)은서로다른물질로형성될수있다. 이는안방수의 배출량을조절하여 안압을효과적으로조절하기 위한목적에 따른것으로,제 1튜브 (10)의 제 1영역 (11)은분해되지 않는물질로형성되어 지속적으로안방수가배출될수있도록지지하는통로의 역할을할수있으며, 제 1튜브 (10)의제 2영역 (12)이 제 2튜브 (20)와같이 생분해성물질로형성되면 별도의조작없이도소정의시간흐름에따라제 2영역 (12, 22)이분해됨으로써 안방수의조절이더욱용이하게 이루어질수있다.
[42] 도 3을참조하면,안구의 전방으로부터 거리가상대적으로가까운영역을제 1 영역 (11, 21),제 1영역 (11, 21)과연결되며 안구의 전방으로부터 거리가 상대적으로먼영역을제 2영역 (12, 22)으로구분할수있는데,제 2영역 (12,
22)은유입되는안방수의 압력을조절하여 안방수가적절한유속및유량으로 배출될수있도록하기위함에그목적이 있다.제 1튜브 (10)의 제 2영역 (12)은 전술한바와같은목적이달성되어 더 이상필요성이 없어진시점인제 2 2020/175812 1»（：1^1{2020/001653
7 튜브 (20)가완전히분해되는시점에 임상의등에 의해주사침등으로열어주는 것과같은방식으로제거될수있으며,제 2영역 (22)이 제거된이후에는 안내에서 제 1튜브 (10)의 제 1영역 (11)만이남아일정한양의 안방수를 배출하도록하여 안압이조절될수있다.
[43] 도 3의如는안질환용임플란트 (100)를도 2의 X축방향으로다른단면도를 나타낸다.즉,도 2및도 3의知)를참조하면제 1튜브 (10)및제 2튜브 (20)의제 2 영역 (12, 22)은 축방향으로제 1영역 (11, 21)에 비해직경이 넓은형태로 형성될수있으며,안방수가유입됨에따라 å축방향으로팽창될수있는구조를 가질수있다.따라서,본발명의 일실시상태에따른제 1튜브 (10)및제 2 튜브 (20)의제 1영역 (11, 21)의 단면은원형일수있고,제 1튜브 (10)및제 2 튜브 (20)의제 2영역 (12, 22)의 단면은타원형일수있다.전술한바에따라 타원형으로형성될수있는제 2영역 (12, 22)의단면에 있어서,긴지름은 축 방향으로형성될수있고,짧은지름은 å축방향으로형성될수있다.
[44] 또한,제 2영역 (12, 22)이 X축방향으로용이하게 팽창가능하도록하기위해 제 1튜브 (10)및제 2튜브 (20)의제 2영역 (12, 22)의두께는제 1영역 (11, 21)에 비해상대적으로얇게 형성될수있다.제 2영역 (12, 22)이 팽창가능한구조를 가지는것은안방수가유입되어튜브내부에서 형성하는압력을조절하기 위함이므로,이러한목적에부합하여 제 2영역 (12, 22)이 팽창되기위해 안방수가고정되어흐를수있도록소정의두께로형성되는제 1영역 (11, 21)과 비교하여 제 2영역 (12, 22)의두께는상대적으로얇게형성될수있다.
[45] 본발명의 일실시상태에 따르면,제 1튜브 (10)의 제 1영역 (11)과제 2
영역 (12)이만나는접점에구멍이 형성될수있으며,구멍을통해의료용실등이 연결되어 안질환용임플란트 (100)가안내에서용이하게고정될수있다.즉, 안질환용임플란트 (100)가안내에삽입된이후제 1튜브 (10)의 임상의등에 의해 제 1영역 (11)과제 2영역 (12)이 만나는접점에 형성된구멍이 의료용실등을 통해 안내의조직과연결됨으로써,안질환용임플란트 (100)가안방수의 압력 또는안내의섬유조직등에의해삽입된영역에서다른영역으로이동하거나 흔들리는등의문제를방지할수있다.
[46] 또한,본발명의 일실시상태에 따른안질환용임플란트 (100)의 일면은안구의 곡면과유사한형태로형성될수있다.이때,안질환용임플란트 (100)의 일면이라 함은안질환용임플란트 (100)가안내에삽입되었을때 안구의유리체방향으로 배치된부분을말하는것으로,이러한일면이 안구의곡면과유사한형태로 형성되는경우임플란트 (100)가더욱안정적으로안내에서고정될수있다.
[47] 도 3의 )및 ( 를참조하면,안방수는제 1영역 (11, 21)으로유입되어 제 2 영역 (12, 22)을통과하여 배출되며,유입되는안방수의 압력을이용하여 안방수가효과적으로배출되도록하기위하여 제 1영역 (11, 21)에 비해제 2 영역 (12, 22)의직경을더 넓게할수있다.이 때,제 1튜브 (10)의 제 1영역 (11)의 직경 ( )은 100 이상일수있으며 ,제 2튜브 (20)의 제 1영역 (21)의직경 ( )은 2020/175812 1»（：1^1{2020/001653
8
30 ^이상 100 ^미만일수있다.바람직하게는분해되기전제 2튜브 (20)의제 1영역 (21)의직경 0 0은 45 / /이의직경을가지도록형성될수있다.앞서
설명하였듯이제 2영역 (12, 22)의직경이제 1영역 (11, 21)의직경보다넓을수 있으므로,제 2튜브 (20)의제 2영역 (22)의직경 ( )는제 1튜브 (10)의제 1 영역 (11)의직경 ( )보다넓을수있다.
[48] 또한,안방수가배출되는제 1튜브 (10)및제 2튜브 (20)의제 2영역 (12, 22)의 배출구와안방수가유입되는제 1튜브 (10)및제 2튜브 (20)의제 1영역 (11,
21)의유입구는직경이동일하거나더넓을수있다.다시말해서,배출구의 직경은최종적으로안질환용임플란트 (100)를통해배출되는안방수의유속을 결정하므로,안질환의정도,안구의상태등에따라안방수의배출속도및 배출량을조절하기위해제 1튜브 (10)및제 2튜브 (20)의제 2영역 (12, 22)의 배출구의직경이제 1영역 (11, 21)의유입구의직경과동일하거나더넓도록 선택적으로형성될수있다.
[49] 본발명의일실시상태에따른제 1튜브 (10)및제 2튜브 (20)의제 1영역 (11, 21)의길이는 7 _이상 이하일수있다.즉,앞서설명하였듯이제 2 영역 (12)이임상의등에의해제거되고나면제 1영역 (11)만을통해안방수를 안구의전방으로부터결막조직또는테논조직으로배출해야하므로,
안정적으로안방수를배출하기위해제 1영역 (11, 21)은상기한범위의길이를 가지도록형성될수있다.
[5이 전술한수치범위내에서임상적으로효과 .적정안방수유지또는안방수 유출등)가두드러지게나타날수있으나,이러한수치에반드시한정되는것은 아니다.환자의안구크기，치료
Figure imgf000010_0001
의하여미리결정된직경 또는길이값을갖도록제작될수도있다.
[51] 도 4는본발명의일실시상태에따른안압의조절을위한안질환용
임플란트 (100)의또근다른일예를나타낸투시도이며,도 5는본발명의일 실시상태에따른안압의조절을위한안질환용임플란트 (100)의또다른일예를 나타낸단면도이다.
[52] 도 4및도 5를참조하면,본발명의일실시상태에따른제 2튜브 (20)는제 2 튜브 (20)의제 2영역 (22)과연결되며,제 2튜브 (20)의제 1영역 (21)과
동일하거나더좁은직경으로형성되는후방튜브 (23)를더포함하며,제 1 튜브 (10)는제 1튜브 (10)의제 2영역 (12)과연결되며,후방튜브 (23)를보호하기 위해후방튜브 (23)를외부에서감싸는형태로형성되는후방보호튜브 (13)를더 포함할수있다.
[53] 다시말해서 ,도 5를참조하면제 2튜브 (20)의후방튜브 (23)는효과적인
안방수의압력조절을위해제 2튜브 (20)의제 2영역 (22)과연결되어
추가적으로형성되는것으로,안질환의정도,안구의상태등에따라안방수의 배출량,배출속도등을결정하여후방튜브 (23)의직경 ( )을제 2튜브 (20)의제 1 영역 (21)의직경 ( )과동일하거나더좁은직경으로형성할수있다. 2020/175812 1»（：1^1{2020/001653
9
[54] 또한,도 5의如를참조하면제 1튜브 (10)의후방보호튜브 (13)는섬유조직에 의해제 2튜브 (20)의후방튜브 (23)가섬유조직에의해막히거나손상되는 경우를방지하기위해후방튜브 (23)를외부에서감싸는형태로형성될수있다. 후방보호튜브 (13)는제 1튜브 (10)의제 2영역 (12)과연결되도록형성되며, 후방튜브 (23)를섬유조직으로부터보호하기위한것이므로제 1튜브 (10)의제 2 영역 (12)보다두꺼운두께로형성될수있다.또한,후방보호튜브 (13)및후방 튜브 (23)는제 1튜브 (10)및제 2튜브 (20)의제 2영역 (12, 22)과마찬가지로제 2 튜브 (20)가완전히분해되는시점에임상의등에의해주사침등으로열어주는 것과같은방식으로제거될수있다.전술한바와같이제거되는방식이 아니더라도,후방보호튜브 (13)및후방튜브 (23)가전술한바와같은생분해성 물질로형성되는경우소정의시간흐름에따라자연스럽게분해되어안방수의 유압및배출량을용이하게조절할수있다.
[55] 도 6은본발명의일실시상태에따른포어여0^)(40)가형성된안압의조절을 위한안질환용임플란트 (100)를나타낸사시도이다.
[56] 도 6의如를참조하면,제 1튜브 (10)의제 2영역 (12)에안질환용
임플란트 (100)의고정을위한포어 (40)가형성될수있다.즉,제 1튜브 (10)의제 2영역 (12)에포어 (40)가형성되는경우,안질환용임플란트 (100)가안내에 삽입된이후에시간이흐름에따라자라난안구의섬유조직이포어 (40)로 유입되어안질환용임플란트 (100)를고정시킬수있다.제 2튜브 (20)에 포어 (40)가형성되면섬유조직이튜브내부로유입되어안방수의이동을방해할 수있으므로,포어 (40)는제 1튜브 (10)에형성되는것이바람직하나목적에따라 제 2튜브 (20)에도형성될수있다.
[57] 또한,도 6의 (비와같이후방튜브 (23)및후방보호튜브 (13)가추가로형성된 경우에도제 1튜브 (10)의제 2영역 (12)또는후방보호튜브 (13)중적어도 하나에안질환용임플란트 (100)의고정을위한포어 (40)가형성될수있다.
전술한바와같이,후방보호튜브 (13)의경우제 1튜브 (10)의제 2영역 (12)보다 후방튜브 (23)의보호를위해상대적으로두꺼운두께로형성되므로후방보호 튜브 (13)에포어 (40)가형성되는것이바람직하나이에한정되는것은아니다. 발명의실시를위한형태
[58] 이하,본발명을구체적으로설명하기위해실시예를들어상세하게
설명하기로한다.그러나,본발명에따른실시예들은여러가지다른형태로 변형될수있으며,본발명의범위가아래에서기술하는실시예들에한정되는 것으로해석되지않는다.본명세서의실시예들은당업계에서평균적인지식을 가진자에게본발명을보다완전하게설명하기위해제공되는것이다.
[59] 실시예 1
[6이 3*3*0.4 111111크기의임플란트기재 (소재 :폴리디메틸실록산또는
폴리테트라플루오로에틸렌)를준비하였다. 2020/175812 1»（：1/10公020/001653
10 아크릴레이트계단량체로서 디펜타에리트리톨펜타아크릴레이트 1중량부및 에틸렌글리콜디메타크릴레이트 2중량부,
메트아크릴로일옥시에틸포스포릴콜린단량체 0중량부,광개시제로서 벤조페논을포함하는조성물을준비하였다.
62] 상기조성물을임플란트기재상에도포하고 11¥를조사하여,상기조성물의 광중합물의 광경화물인코팅층이 형성된안압조절을위한안질환용
임플란트를제조하였다. 비교예 1
임플란트로서코팅층이 형성되지 않은 3*3*0.4 mm크기의 임플란트 기재 (소재 :폴리디메틸실록산또는폴리테트라플루오로에틸렌)를준비하였다. 심험동물모템제작및경막과참
1.5 kg내지 2.0kg의 체중을갖는토끼 (New Zealand white rabbit) 12마리의 우안에실시예 1의 임플란트를삽입하고,좌안에 비교예 1의 임플란트를 삽입하였다.
69] 실시예 1의 임플란트가삽입된우안및비교예 1의 임플란트가삽입된좌안의 결막을임플란트삽입한날로부터 2주후,육안으로관찰하였다.도 7은실시예 1의 임플란트가삽입된우안및비교예 1의 임플란트가삽입된좌안의결막을 임플란트삽입한날로부터 2주후에카메라로찍은사진이다. 성유아세포수및성유화막두께확이
임늘란트를삽입하고 2주후 8 ml/Kg Tiletamine/Zolazepham 1: 1 mixture를토끼 12마리에주사하여마취시킨후안구를적출하였다.안구적출시윤부주위 470235681
7776666666 결막과테논조직이 떨어지지 않도록포함시켜박리하였으며,이후 0.4 M
포스페이트버퍼 (PB: pH 7.4)로희석한 4 %파라포름알데히드에 3시간동안 담가고정시켰다.고정액에서꺼내어 면도날로 axial절개면 (axial section)으로 나눈후 0.1M PB에담가세척하였다.일련의단계별에탄올로탈수시킨후왁스 (polyethylene glycol 400 disterate; Polysciences, Warrington, PA)를입혔다.
미세절개도로안구를 5 [mi크기의 sagittal절개면 (sagittal section)으로자른다음 젤라틴이 칠해진슬라이드위에올려표본을만들었다.왁스를제거한후 재수화시키고 H & E(Hematoxylin & Eosin)염색을시행하였다.
[73] 광학현미경으로 X 200확대하에서 테논조직속에 있는
섬유아세포 (fibroblast)의 개수및섬유화막의두께를측정하였다.도 8은실시예 1의 임플란트가삽입된표본의광학현미경사진에섬유아세포의수와섬유화막 두께의측정방법을개략적으로나타낸도면이다.구체적으로,섬유화가관찰된 부분 (도 8(a)의사각형부분)중결막부위 3부분과공막부위 3부분 (도 8(b)의 사각형부분)에서각각임의로 100 X 100 크기의사각형부분 (도 8(c)의 2020/175812 1»（：1^1{2020/001653
11 사각형부분）을두군데정하여사각형에서관찰되는세포수를즉정하였다. 또한,사각형근처의 임의지점에서섬유화막의두께를측정하였다.결막부위 3부분과공막부위 3부분의세포수와섬유화막두께의 평균값을하기표 1에 나타내었다.
[74]
[표 1]
Figure imgf000013_0001
[76] 도 7에 따라실시예 1의 임플란트를삽입한우안이 비교예 1의 임플란트를 삽입한좌안보다충혈정도가감소한것을확인할수있었다.또한,표 1에 따라 실시예 1의 임플란트를삽입한우안의 임플란트주변의섬유아세포의수및 섬유화막두께가비교예 1의 임플란트를삽입한좌안의 임플란트주변의 섬유아세포의수및섬유화막두께보다적고얇은것을확인할수있었다.
[78] 따라서,본발명의 일실시상태에 따른안질환용임플란트는임플란트기재의 외부에 2개 이상 6개 이하의 아크릴레이트기를포함하는아크릴레이트계 단량체;및（메트）아크릴로일옥시에틸포스포릴콜린단량체;를포함하는 조성물의중합물의경화물인코팅층을포함함으로써,세포및단백질이 흡착되고변성되는것을방지할수있으며 ,이에따라섬유화,혈전형성,염증, 조직괴사같은이물반응도방지할수있다는것을알수있었다.
［부호의 설명］
90
7 787 75
1 :눈의 각막 2:눈의수정체
81] 3:눈의 망막 4:눈의결막조직또는테논조직
82] 10:제 1튜브 11 :제 1튜브의 제 1영역
83] 12:제 1튜브의 제 2영역 13:제 1튜브의후방보호튜브
84] 20:제 2튜브 21 :제 2튜브의 제 1영역
85] 22:제 2튜브의 제 2영역 23:제 2튜브의후방튜브
86] 30:코팅증 40:포어
871 100:안질환용임플란트

Claims

2020/175812 1»（：1/10公020/001653
12 청구범위
［청구항 1］ 임플란트기재;및
상기임플란트기재의외부에형성되는코팅층을포함하는안압조절을 위한안질환용임플란트로서 ,
상기코팅층은 2개이상 6개이하의아크릴레이트기를포함하는 아크릴레이트계단량체 ;및（메트）아크릴로일옥시에틸포스포릴콜린 단량체;를포함하는조성물의중합물의경화물인안질환용임플란트.
［청구항 2］ 제 1항에 있어서,
상기코팅층은물에대한접촉각이 。이상 50ᄋ이하인안질환용 임플란트.
［청구항 3］ 제 1항에 있어서,
상기아크릴레이트계단량체는디펜타에리트리톨펜타아크릴레이트, 디펜타에리트리톨핵사아크릴레이트,에틸렌글리콜디메타크릴레이트 및에틸렌글리콜디아크릴레이트중에서선택된 1종이상인안질환용 임플란트.
［청구항 4］ 제 1항에 있어서,
상기아크릴레이트계단량체는상기
（메트）아크릴로일옥시에틸포스포릴콜린단량체 0중량부에대하여 1 중량부이상 5중량부이하의함량으로포함되는안질환용임플란트.
［청구항 5］ 제 1항에 있어서,
상기코팅층은두께가 0 11111이상 300 11111이하인안질환용임플란트. ［청구항 6］ 제 1항에 있어서,
상기임플란트기재는안압조절을위해안방수가유입되는제 1튜브;및 상기제 1튜브의내부에형성되는제 2튜브;를포함하고, 상기제 2튜브는안 句내부로삽입된이후소정의시간이흐름에따라 안내에서분해되는생분해성물질로형성되며,
상기제 1튜브및제 2튜브는안구의
Figure imgf000014_0001
거리에따라제 1영역및제 2영역으로구분가능하고,상기제 1튜브및 제 2튜브의제 2영역은상기제 1튜브및제 2튜브의제 1영역에비해 직경이넓고상기안방수가유입됨에따라팽창가능한구조인안질환용 임플란트.
［청구항 7］ 제 6항에 있어서,
상기제 1튜브및제 2튜브의제 1영역의단면은원형이고,상기제 1 튜브및제 2튜브의제 2영역의단면은타원형인안질환용임플란트.
［청구항 8］ 제 6항에 있어서,
상기제 1튜브의제 1영역은직경이 100 이상이며 ,상기제 2튜브의 제 1영역은직경이 30 ^이상 100 ^미만인안질환용임플란트. 2020/175812 1»（：1^1{2020/001653
13
[청구항 9] 제 6항에 있어서,
상기 제 1튜브및제 2튜브의제 1영역은길이가 7111111
Figure imgf000015_0001
이하인 안질환용임플란트.
[청구항 10] 제 6항에 있어서 ,
상기 제 2튜브는상기 제 2튜브의제 2영역과연결되며,상기제 2 튜브의 제 1영역과동일하거나더좁은직경으로형성되는후방튜브를 더포함하며,
상기 제 1튜브는상기 제 1튜브의제 2영역과연결되며,상기후방 튜브를보호하기위해상기후방튜브를외부에서감싸는형태로 형성되는후방보호튜브를더포함하는안질환용임플란트.
PCT/KR2020/001653 2019-02-27 2020-02-05 코팅층을 포함하는 안질환용 임플란트 WO2020175812A1 (ko)

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