Classifications

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  • 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
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• • A—HUMAN NECESSITIES
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  • 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
  • A61F2/02—Prostheses implantable into the body
  • A61F2/28—Bones
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  • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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  • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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  • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
  • A61L27/14—Macromolecular materials
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  • B29C35/00—Heating, cooling or curing, e.g. crosslinking or vulcanising; Apparatus therefor
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  • B29C39/00—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
  • B29C39/003—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor characterised by the choice of material
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  • C08J3/02—Making solutions, dispersions, lattices or gels by other methods than by solution, emulsion or suspension polymerisation techniques
  • C08J3/03—Making solutions, dispersions, lattices or gels by other methods than by solution, emulsion or suspension polymerisation techniques in aqueous media
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  • C08J3/24—Crosslinking, e.g. vulcanising, of macromolecules
  • C08J3/246—Intercrosslinking of at least two polymers
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  • A61L2430/00—Materials or treatment for tissue regeneration
  • A61L2430/12—Materials or treatment for tissue regeneration for dental implants or prostheses
• • B—PERFORMING OPERATIONS; TRANSPORTING
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  • B29K2071/00—Use of polyethers, e.g. PEEK, i.e. polyether-etherketone or PEK, i.e. polyetherketone or derivatives thereof, as moulding material
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• • B—PERFORMING OPERATIONS; TRANSPORTING
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  • B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
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• • B—PERFORMING OPERATIONS; TRANSPORTING
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  • B29K2995/00—Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
  • B29K2995/0037—Other properties
  • B29K2995/0088—Molecular weight
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  • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
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Definitions

• Hydrogel that can control the rate of decomposition in the body and its manufacturing method
• the present invention relates to a dental hydrogel and a method for manufacturing the same, and more particularly, to a hydrogel and a method for manufacturing the hydrogel that can be rapidly decomposed after completion of bone regeneration at a certain time, which can be controlled in the body.
• a hydrogel membrane that can be freely applied to bone defects and a method of manufacturing the same.
• the sheet-type dental membrane had to use the cut sheet to fit the shape of bone defects, there was a hassle that the total procedure time is extended,
• the sheet-type membrane is mainly composed of collagen, so its absorption into the body is fast, and thus, space maintenance and soft tissue shielding function are weak.
• US Patent No. 6306922 discloses a photopolymerizable hydrogel type membrane, but such a photopolymerized hydrogel type membrane has a problem of very low decomposition in the body due to high physical strength.
• hydrogel-type membrane using the H-type membrane has a problem that it is difficult to disintegrate at an appropriate time due to the strong physical strength.
• An object of the present invention is to provide a hydrogel and a method for producing the same, which can be rapidly decomposed after a certain point, that is, bone regeneration is possible to control the decomposition rate in the body to solve the above problems.
• Another object of the present invention is to provide a hydrogel gel membrane and a method of manufacturing the same, which can be freely applied regardless of the shape of bone defects in order to overcome inconveniences of conventional sheet type membranes.
• the present invention has a functional group capable of photopolymerization PEG (polyethylene glycol), together with the photopolymerized PEG to form an interpenetrating polymer network (IPN), a natural polymer additive having a higher viscosity and faster biodegradation rate than the PEG, and to initiate photopolymerization of the PEG It provides a hydrogel and a hydrogel membrane comprising a photopolymerization initiator for generating radicals.
• PEG polyethylene glycol
• the present invention is i) photopolymerization that produces a first polymer containing PEG having a functional group capable of photopolymerization, and a natural polymer additive having a higher viscosity and faster biodegradation rate than the PEG and a radical for initiating photopolymerization of the PEG.
• Preparing a second liquid form containing an initiator ii) mixing the prepared first liquid form and a second liquid form in a cavity, and iii) irradiating visible light to the mixed solution to form an interpenetrating polymer network (IPN).
• IPN interpenetrating polymer network
• the present invention is i) generating a first liquid containing a PEG having a functional group capable of photopolymerization, and a natural polymer additive having a higher viscosity and faster biodegradation rate than the PEG and a radical for initiating photopolymerization of the PEG Preparing a second liquid form containing a photopolymerization initiator, ii) mixing the prepared first liquid form and a second liquid form through a cavity, iii) shaping the mixed solution into a membrane form, and iv) It provides a method for producing a hydrogel gel membrane comprising the step of forming a hydrogel in the interpenetrating polymer network (IPN) form by irradiating visible light in the wavelength range of 400 ⁇ 750 nm to the membrane.
• IPN interpenetrating polymer network
• the present invention is i) generating a first liquid containing a PEG having a functional group capable of photopolymerization, and a natural polymer additive having a higher viscosity and faster biodegradation rate than the PEG and a radical for initiating photopolymerization of the PEG Preparing a two-component type crab containing a photopolymerization initiator; ii) mixing the prepared first liquid type and the second liquid type in a cavity; Hi) irradiating visible light to the mixed solution to form an interpenetrating polymer network. It provides a method of producing a hydrogel gel comprising the step of forming a hydrogel (IPN) form, and iv) shaping the hydrogel in the form of a membrane.
• IPN hydrogel
• the photopolymerizable functional group may be any one or more of acrylate, methacrylate, coumarin, thymine, and cinnamate.
• the natural polymer additive forming an interpenetrating polymer network with the PEG is carboxyl Any one or more of methyl salose, heparan sulfate, hyaluronic acid, collagen, chitosan, dextran and alginate may be used, wherein the molecular weight of the natural polymer additive is preferably 100, 000-10,000, 000. .
• the photopolymerization initiator may react with visible light having a wavelength of 400 to 750 nm to generate radicals.
• Dental hydrogel of the present invention can be freely treated irrespective of the shape of the bone defect, as well as having a form of interpenetrating polymer network (IPN) made of PEG and natural polymer additives to control the decomposition rate in the body at a certain point In other words, it maintains space and soft tissue shielding function until bone regeneration is completed, but can be rapidly decomposed after bone regeneration is completed.
• IPN interpenetrating polymer network
• Figure 4-Visual and histological evaluation of the 1 week acute inflammatory response of the hydrogel membrane through subcutaneous transplantation such as rat ⁇ : hydrogel membrane residual subcutaneous implant, PEG: photopolymerized PEG hydrogel membrane, PEG + C0L + HA: present Photopolymerized PEG hydrogel gel membrane in which collagen and hyaluronic acid prepared by the method of the invention are combined with IPN)
• the hydrogel of the present invention forms an interpenetrating polymer network (IPN) together with a PEG having a photopolymerizable functional group, a photopolymerized PEG, a natural polymer additive having a higher viscosity and a faster biodegradation rate than the PEG, and It has a configuration comprising a photopolymerization initiator for generating radicals for initiating photopolymerization, photopolymerized PEG and natural It is characterized by having a form of interpenetrating polymer network (IPN) formed by mixing the molecular additives.
• IPN interpenetrating polymer network
• the hydrogel using photopolymerization used in the conventional membrane is a high-density polymer network structure in which several PEGs are cross-linked at one linking point, and thus exhibits high physical strength, thereby not decomposing even after bone regeneration is completed.
• the membrane itself acts as an obstacle to the fusion of hard and soft tissue.
• the natural polymer additive constituting the interpenetrating polymer network is decomposed first at an appropriate decomposition point, so that the internal network structure of the hydrogel is reduced. It becomes loose and immune cells easily penetrate into the loose network, resulting in rapid in vivo degradation of the membrane.
• the natural polymer additive may be used a variety of natural polymer material having a faster biodegradation rate than PEG, preferably any one of carboxy methyl cellulose, heparan sulfate, hyaluronic acid, collagen, chitosan, dextran and alginate This phase can be used.
• the molecular weight of the natural polymer additive is preferably in the range of 100,000 ⁇ 10,00 000.
• the PEG component may have various functional groups capable of photopolymerization, and may preferably have one or more functional groups of acrylate, methacrylate, coumarin, thymine, and cinnamate.
• the photopolymerization initiator serves to generate radicals for initiating the photopolymerization of the PEG, and may preferably generate radicals by reacting to visible light having a wavelength of 400 to 750 nm.
• the hydrogel is i) photopolymerized with a first liquid form containing PEG and a natural polymer additive Preparing a second liquid form containing an initiator, ii) mixing the prepared first liquid form and a second liquid form in a cavity, and iii) irradiating visible light to the mixed solution to form an interpenetrating polymer network (IPN) form.
• IPN interpenetrating polymer network
• the membrane using the hydrogel has i) preparing a first liquid form containing PEG, and a second liquid form containing a natural polymer additive and a photopolymerization initiator; ii) preparing the first liquid form and the second liquid form.
• the manufacturing method of the hydrogel of the present invention first preparing a first liquid form containing PEG, and a second liquid form containing a natural polymer additive and a photopolymerization initiator, the prepared first liquid form And mixing the second component through the cavity.
• the natural polymer additive serves to prevent the flow to the peripheral portion by imparting viscosity (viscosity) to the mixed solution, it is preferable to have a higher viscosity than PEG.
• the mixed solution as described above has a viscosity that does not flow to the periphery, so that the mixed solution is applied to the bone defects in the form of an injectable container or the like, or directly applied to the mammalian bone defects to provide a suitable membrane. It can be freely formed into a shape, and finally the hydrogel gel membrane of the interpenetrating polymer network (IPN) form can be prepared by irradiating and polymerizing the shaped membrane by visible light.
• IPN interpenetrating polymer network
• FIGS. 3 to 5 Data related to the degradability and body safety of the hydrogel membrane prepared as described above can be confirmed through FIGS. 3 to 5.
• FIG. 3 after analyzing similar enzyme reaction conditions in the body, the degradation of the hydrogel membrane was evaluated.
• the polymer network is dense, so that the degradation due to hydrolysis and enzyme reaction is relatively low. Remaining.
• PEG + COL + HA hydrogel membranes in which collagen (C0L) and hyaluronic acid (HA) cross-linked PEG and ⁇ structures are similar to PEG hydrogel membranes. After the degradation of collagen and hyaluronic acid, the internal network structure was loosened, and the degree of swelling was relatively increased.
• the actual body condition is not an environment in which excessive excess fluid is present as in the above experimental condition, and thus the result may not be representative of the decomposition behavior in the body, but may be used as a basis for predicting tendency.
• FIG. 4 is a photograph showing the results of acute inflammatory lesions at 1 week after the implantation of each hydrogel membrane.
• PEG and PEG + COL + HA In all hydrogel membrane systems, early acute inflammatory reactions of surrounding tissues were not observed and histological analysis showed no specific inflammatory reactions except for normal tissue reactions on raw materials. Therefore, it was confirmed that the hydrogel membrane of the present invention satisfies biocompatibility.
• FIG. 5 shows the results of evaluation of in vivo degradability of hydrogel membrane with histocompatibility characteristics.
• the degradation tendency in the body is not the same as the result of FIG. 3, but the difference in degradation tendency between the two hydrogels was similarly observed after a certain point in time.
• the degradability in the body rapidly increases after 8 weeks, resulting in about 60%, At 16 weeks, most of the membranes degraded in the body.
• collagen and hyaluronic acid can be PEG-IPN structured to give a degradation rate control function that accelerates the degradation in the body after a certain point, whereas the photopolymerized hydrogel composed of only PEG exhibits a tendency to slowly degrade in the body linearly. It was.
• the visible solution is directly irradiated with visible light directly to the mixed solution of the first liquid type and the second liquid type, and then hydrated in the form of a hydrogel, and then the hydrogel is applied by applying an appropriate pressure.
• Membranes may also be prepared.

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