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WO2024208183A1 - 一种口腔给药器及其制备方法和应用 - Google Patents

一种口腔给药器及其制备方法和应用 Download PDF

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Publication number
WO2024208183A1
WO2024208183A1 PCT/CN2024/085477 CN2024085477W WO2024208183A1 WO 2024208183 A1 WO2024208183 A1 WO 2024208183A1 CN 2024085477 W CN2024085477 W CN 2024085477W WO 2024208183 A1 WO2024208183 A1 WO 2024208183A1
Authority
WO
WIPO (PCT)
Prior art keywords
functional area
molar
ring
section
teeth
Prior art date
Application number
PCT/CN2024/085477
Other languages
English (en)
French (fr)
Inventor
范茗
董良昶
刘哲鹏
魏晓雄
Original Assignee
上海汉都医药科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202310366350.9A external-priority patent/CN118767308A/zh
Priority claimed from CN202320730369.2U external-priority patent/CN219764274U/zh
Application filed by 上海汉都医药科技有限公司 filed Critical 上海汉都医药科技有限公司
Publication of WO2024208183A1 publication Critical patent/WO2024208183A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body

Definitions

  • the present invention specifically relates to an oral drug delivery device and a preparation method and application thereof.
  • a drug delivery system that can provide long-term drug component exposure is needed, which is suitable for drugs with absorption windows in the upper gastrointestinal tract or requiring oral topical administration.
  • the drug is loaded by a drug delivery device, and fixed in the oral cavity after being combined with a fixer to form a drug controlled release system, providing long-term exposure of drugs with absorption windows limited to the upper gastrointestinal tract.
  • patent applications US10668274 and CN1997421A disclose an oral drug-containing container based on an electrically controlled drug release mechanism.
  • the drug-containing container and the electrically controlled system claimed in the patent are difficult to implement.
  • CN105873631A discloses an oral drug delivery device, which requires an electronic pump or a mechanical pump as an external power to achieve drug delivery.
  • CN1925823A discloses a tooth bracket for attaching a fluoride pill body to teeth to improve the treatment or prevention of caries. This patent application does not involve drug absorption in the upper gastrointestinal tract.
  • patent application CN109908461A discloses an oral drug delivery device for dentures, braces or oral implants, which is suitable for oral mucosal drug delivery and does not involve drug absorption in the upper gastrointestinal tract.
  • the above-mentioned patent applications that have been published may require external power, or need to rely on dentures, braces, etc. to achieve, or do not involve drug absorption at the absorption end in the upper gastrointestinal tract.
  • CN114191307A and CN212973560U disclose an oral retention device for retaining tablets in the oral cavity, providing long-term exposure of drugs with absorption windows limited to the upper gastrointestinal tract, so as to obtain long-term stable blood drug concentration.
  • the oral retention device has taken into account that the tablet is inserted from the back to the front, close to the throat and blocked by oral tissues such as the buccal fat pad tip, so that the tablet is not easy to fall off when the device is worn.
  • the tooth-matching component in the oral retention device can fit the patient's teeth according to the personalized design, making it stable to wear.
  • the oral retention device may be poorly retained and there is a risk of tilting or falling off.
  • the above-mentioned intraoral drug delivery devices do not take into account the wearing firmness under special oral conditions, and the complex structure or large device volume may cause poor wearing comfort and safety for patients, and will also have a great impact on the facial appearance when worn.
  • the present invention provides an oral applicator and its preparation method and application.
  • the present invention provides an oral applicator for inserting tablets from back to front, which is composed of a core component and a fixing device, which can keep the oral applicator and tablets stably in the oral cavity and will not fall off with oral movements.
  • the long-term release of drugs with an absorption window limited to the upper end of the gastrointestinal tract, as well as oral mucosal administration or drug release acting locally in the oral cavity can be achieved by patients wearing the applicator.
  • the oral applicator is highly comfortable when used and has little impact on facial appearance.
  • the present invention provides an oral drug delivery device, which comprises a core component and a fixing device, wherein the core component comprises an integrally formed molar anastomotic functional area and a drug-carrying functional area;
  • the drug-carrying functional area is located in the space between the teeth and the cheek, or the drug-carrying functional area is located in the space between the teeth and the tongue;
  • the molar anastomosis functional area includes a first section close to the drug-carrying functional area and a second section away from the drug-carrying functional area; one end of the first section and the second section are connected to each other, and the other end is an open end, forming a U-shaped structure; the first section and the second section are respectively used to anastomose with the buccal side and the lingual side of the tooth, and are used to fix the drug-carrying functional area on the tooth;
  • the drug-carrying functional area comprises a first ring and a second ring arranged coaxially; the axial clamping space formed between the first ring and the second ring is used to fix the drug;
  • the fixing device is a fixing device or a fixing layer, which is used to strengthen the fixing effect of the core component on the teeth;
  • the lingual side, buccal side and occlusal surface of the retainer are correspondingly matched with the lingual side, buccal side and occlusal surface of the teeth and covered on the outer peripheral surface of the teeth; the retainer also covers the molar matching functional area;
  • the fixing device is a fixing layer:
  • the fixing layer is attached to the outer surfaces of the first section and the second section for contacting with teeth.
  • the first ring and the second ring are preferably located on the buccal side of the first or second molar.
  • the fixture and the molar anastomotic functional area are preferably connected by mechanical assembly, mechanical connection or adhesive bonding.
  • the mechanical assembly is preferably embedded, and a slot is opened on the fixture at the position corresponding to the drug-carrying functional area to achieve detachable fixation of the fixture and the core component.
  • the embedding means that the molar anastomosis functional area is embedded in the space formed on both sides of the fixture.
  • the mechanical connection is preferably welding, riveting or bolting.
  • the adhesive is preferably one or more of pressure-sensitive adhesive, starch adhesive, latex, epoxy resin and polyurethane acrylate.
  • the fixing layer is preferably also attached to other outer surfaces of the first section and the second section.
  • the first ring is close to the open end of the molar anastomotic functional area, and the second ring is away from the molar.
  • the first ring and the second ring are preferably solid or hollow ring structures.
  • the hollow annular structure is a closed loop or an open loop.
  • the shape of the annular structure is preferably one or more of circular, elliptical and polygonal.
  • the shapes of the annular structures of the first ring and the second ring are preferably circular; the hollow area of the first ring is preferably smaller than the hollow area of the second ring, and the tablet can be inserted from the second ring into the first ring.
  • the material of the core component is preferably one of titanium, stainless steel, cobalt-chromium alloy, cobalt-chromium-molybdenum alloy or precious metal, more preferably cobalt-chromium alloy, and the material of the core component meets the standards of materials used in dentistry.
  • the material of the fixator is preferably one or more of polyvinyl chloride, polyethylene terephthalate, polyethylene terephthalate-1,4-cyclohexanedimethanol ester, polyurethane, polyamide, ethylene-vinyl acetate copolymer, polycaprolactone, high-density polyethylene, polypropylene, epoxy acrylate, methacrylate, and polyurethane acrylate; more preferably, polyethylene terephthalate or ethylene-vinyl acetate copolymer.
  • the material of the fixator meets medical grade standards.
  • the material of the fixing layer is preferably one or more of polyvinyl chloride, polyethylene terephthalate, polyethylene terephthalate-1,4-cyclohexanedimethanol, polyurethane, polyamide, ethylene-vinyl acetate copolymer, polycaprolactone, high-density polyethylene, polypropylene, cellulose acetate, hydroxypropyl cellulose and copolyvidone, more preferably polyethylene terephthalate or copolyvidone, and the material of the fixing layer meets medical grade standards.
  • the thickness of the fixing layer is preferably 0.01 mm-1 mm.
  • the number of teeth covered by the retainer can be adjusted according to the tooth condition and the wearing firmness, and the length of the retainer is preferably corresponding to the length of 4 to 16 teeth in the upper or lower jaw, and more preferably corresponding to the length of 5 to 9 teeth in the upper or lower jaw.
  • the length of the molar anastomotic functional area is preferably corresponding to the length of 2 to 5 teeth in the mandible.
  • the length is a length that enables the fixture or the molar anastomotic functional area to cover the number of teeth and does not exceed the number of teeth in the target range.
  • the fixture is connected to the molar anastomosis functional area in an embedded manner, and a slot is provided on the fixture at a position corresponding to the drug-carrying functional area to achieve detachable fixation of the fixture and the core component;
  • the length of the molar anastomosis functional area corresponds to the length of the mandibular first and second premolars and the first and second molars;
  • the first ring and the second ring are circular closed rings.
  • the fixture is connected to the molar anastomosis functional area in an embedded manner; the length of the molar anastomosis functional area corresponds to the length of the mandibular first and second premolars and the first and second molars; the first ring and the second ring are elliptical closed rings.
  • the fixture is connected to the molar anastomosis functional area in an embedded manner; the length of the molar anastomosis functional area corresponds to the length of the maxillary second premolar and the first, second and third molars, and the first ring and the second ring are circular closed rings.
  • the fixture is connected to the molar anastomosis functional area by bonding using a pressure-sensitive adhesive; the length of the molar anastomosis functional area corresponds to the length of the first, second and third molars; the first ring and the second ring are polygonal closed loops.
  • the fixing layer is attached to the entire outer surface of the first section of the U-shaped structure and the second section of the U-shaped structure; the length of the molar anastomosis functional area corresponds to the length of the mandibular first and second premolars and the first and second molars; the first ring and the second ring are circular closed rings.
  • a pair of clamping walls are symmetrically provided on the first ring along the direction of the open end of the molar anastomotic functional area.
  • the present invention also provides a method for preparing the above-mentioned oral applicator, which comprises the following steps: when the fixing device is a fixer, combining the fixer with the first section and the second section formed integrally in a coated form; when the fixing device is a fixing layer, attaching the fixing layer to the outer surface of the first section and the second section formed integrally.
  • the preparation method of the core component preferably includes laser melting, injection molding or die molding.
  • the laser melting and casting steps are preferably: scanning the subject's oral cavity or taking an oral mold to make a plaster model and then scanning it to obtain the subject's oral data; using three-dimensional design software and dental design software to respectively design the drug-loading functional area and molar anastomosis functional area of the core component, and combining them in the dental design software to generate a core component design file; preparing the core component by laser melting and casting, grinding, polishing, and cleaning.
  • the injection molding step is preferably as follows: taking a mouth mold from a subject to make a plaster model; using dental wax as a material to prepare a dental wax model on the plaster model, and preparing a core component by a traditional injection molding process.
  • the method for preparing the fixator preferably includes lamination, molding, cutting or 3D printing.
  • the laminating step is preferably as follows: the raw material of the fixture is heated and softened by a laminating machine and then vacuumed, so that the raw material of the fixture covers the dental model and the molar anastomotic functional area.
  • the impression step is preferably as follows: heating and softening the raw material of the fixture, and covering the teeth of the test subject and the molar matching functional area.
  • the raw material of the fixator is preferably as described above.
  • the method for preparing the fixing layer preferably includes dipping, spraying or lamination.
  • the dipping step is preferably as follows: after dissolving the raw material of the fixing layer, immersing the molar anastomotic functional area into the raw material solution of the fixing layer, taking it out, and drying it to form a film.
  • the spraying step is preferably as follows: dissolving the raw material of the fixing layer and applying it to the molar anastomotic functional area by spraying, and then drying to form a film.
  • the lamination step is preferably as follows: heating and softening the raw material of the fixing layer, covering the molar anastomotic functional area, and then cooling.
  • the raw material of the fixing layer is preferably as described above.
  • the fixing device and the covering structure of the first section and the second section are preferably formed by mechanical assembly, mechanical connection or adhesive bonding.
  • the mechanical assembly is preferably in the form of embedding.
  • the retainer When the combination is mechanically assembled, the retainer fits with the dental mold and the core component during the molding process to naturally form a slot-like structure. At the same time, a buckle design can be added to the molar anastomosis functional area as needed.
  • the mechanical connection is preferably in the form of welding, riveting or bolting.
  • the adhesive is preferably applied on the outer surfaces of the first section and the second section that are in contact with teeth, and more preferably on the entire outer surfaces of the first section and the second section.
  • the coating thickness of the adhesive is preferably no more than 1.0 mm.
  • the present invention also provides an application of the above-mentioned oral drug delivery device, characterized in that: when the fixing device is a fixture: the lingual side, buccal side and occlusal surface of the fixture are correspondingly matched with the lingual side, buccal side and occlusal surface of the teeth and covered on the outer peripheral surface of the teeth; the drug-carrying functional area is placed in the space between the teeth and the cheek, or the drug-carrying functional area is placed in the space between the teeth and the tongue; and the fixture is used to cover the molar matching functional area;
  • the fixing device is a fixing layer: the drug-carrying functional area is placed in the space between the teeth and the cheek, or the drug-carrying functional area is placed in the space between the teeth and the tongue.
  • the reagents and raw materials used in the present invention are commercially available.
  • the present invention provides an oral drug delivery device that matches the teeth in the oral cavity and has a very low risk of falling off.
  • the tablets are inserted into the drug-carrying functional area of the drug delivery device from the back side to the front side, and the oral drug delivery device after the combined tablets is fixed on the corresponding teeth in the oral cavity, so that the sustained release of the drug can be achieved, and the drug includes but is not limited to the drug whose absorption window is limited to the upper gastrointestinal tract and the drug acting locally in the oral cavity.
  • the oral medicator of the present invention does not require external power, nor does it require adjustment of the patient's teeth, and is easy to wear and operate.
  • the oral medicator of the present application is highly secure to wear, that is, highly safe, and can avoid accidental swallowing or choking caused by the medicator loosening and falling off; the oral medicator of the present application has little impact on the patient's facial appearance when worn, and has a high degree of aesthetics when worn; at the same time, the oral medicator is also highly comfortable.
  • Figure 1 is a schematic diagram of the structure of the various components of the oral drug delivery device of Example 1 of the present invention, which is composed of a core component 1 and a fixing device 2, wherein the core component 1 includes a molar anastomosis functional area 11 and a drug loading functional area 12, and the drug loading functional area 12 is composed of a first ring 121 and a second ring 122.
  • FIG. 2 is a schematic structural diagram of the core components of the oral medicating device according to Example 1 of the present invention.
  • FIG3 is a schematic diagram of the structure of a holder when the fixing device in the oral medicating device of Example 1 of the present invention is a holder.
  • Fig. 4 is a cross-sectional view along the A-A plane of Fig. 1 .
  • FIG5 is a schematic structural diagram of the oral applicator of Example 2.
  • FIG6 is a schematic structural diagram of the oral applicator of Example 3.
  • FIG. 7 is a schematic structural diagram of the oral applicator of Example 6.
  • Fig. 8 is a cross-sectional view along the B-B plane of Fig. 7 .
  • FIG. 9 is a schematic structural diagram of the oral applicator of Example 9.
  • 1-core component 2-fixing device; 201-lingual side of the fixing device; 202-buccal side of the fixing device; 203-occlusal surface of the fixing device; 11-molar anastomotic functional area; 12-drug loading functional area; 121-first ring; 122-second ring; 123-clamping wall.
  • This embodiment is an oral medicator that covers all mandibular teeth, as shown in FIG1 , and includes a core component 1 and a fixing device 2, the fixing device 2 being a fixing device, the core component 1 structural schematic diagram is shown in FIG2 , the fixing device 2 structural schematic diagram is shown in FIG3 , and the oral medicator cross-sectional diagram is shown in FIG4 .
  • the lingual side 201 of the fixing device, the buccal side 202 of the fixing device, and the occlusal surface 203 of the fixing device are correspondingly matched with the lingual side, buccal side, and occlusal surface of the teeth and coated on the outer peripheral surface of the teeth; the fixing device 2 also covers the molar anastomosis functional area 11.
  • the core component 1 is composed of the molar anastomosis functional area 11 and the drug-carrying functional area 12, the molar anastomosis functional area 11 can be tightly fitted with the mandibular first and second premolars and the first and second molars in the subject's oral cavity, and the size of the drug-carrying functional area 12 allows it to accommodate at least one tablet and fix the tablet in the oral cavity.
  • the fixing device 2 is tightly fitted with all the mandibular teeth of the subject and is tightly fitted with the molar anastomosis functional area 11, so that the core component 1 and the tablet are fixed in the oral cavity.
  • the molar anastomosis functional area 11 and the drug-carrying functional area 12 are made of cobalt-chromium alloy, and the molar anastomosis functional area 11 and the drug-carrying functional area 12 are connected at their respective sides.
  • the drug-carrying functional area 12 includes a first ring 121 and a second ring 122, and the first ring 121 and the second ring 122 are circular closed loops. The tablet is inserted from the second ring 122 and blocked by the first ring 121.
  • the molar anastomosis functional area 11 and the fixing device 2 are combined in an embedded mechanical assembly manner, and a slot is provided at the position corresponding to the drug-carrying functional area 12 on the fixing device 2 to realize the detachable fixation of the fixing device 2 and the core component 1.
  • the fixing device 2 is made of colorless and transparent polyethylene terephthalate and covers all mandibular teeth, that is, 14 teeth. After the core component 1 and the fixing device 2 are combined, they match the teeth in the subject's mouth.
  • the oral applicator of this embodiment can be firmly worn in the oral cavity after being loaded with tablets, and the tablets are fixed in the oral cavity.
  • the fixator, core component and tablets will not fall off or shift with the movement of the oral cavity. It is very comfortable to wear and has little impact on the facial appearance.
  • the present embodiment is an oral drug delivery device that covers 10 mandibular teeth, as shown in FIG5 , and includes a core component 1 and a fixing device 2.
  • the fixing device 2 is a fixing device.
  • the core component 1 is composed of a molar anastomosis functional area 11 and a drug-carrying functional area 12.
  • the molar anastomosis functional area 11 can be tightly fitted with the mandibular first and second premolars and the first and second molars in the subject's oral cavity.
  • the size of the drug-carrying functional area 12 allows it to accommodate at least one tablet and fix the tablet in the oral cavity.
  • the fixing device 2 is tightly fitted with part of the subject's mandibular teeth (including the teeth from the left canine to the right second molar), and is tightly fitted with the molar anastomosis functional area 11, so that the core component 1 and the tablet are fixed in the oral cavity.
  • the molar anastomosis functional area 11 and the drug-carrying functional area 12 are made of cobalt-chromium alloy, and the molar anastomosis functional area 11 and the drug-carrying functional area 12 are connected at their respective sides.
  • the drug-carrying functional area 12 includes a first ring 121 and a second ring 122.
  • the first ring 121 and the second ring 122 are elliptical closed rings.
  • a pair of clamping walls 123 are symmetrically provided on a ring 121 along the direction of the open end of the molar anastomosis functional area, which is suitable for the insertion of non-cylindrical tablets.
  • the tablets are inserted from the second ring 122 and blocked by the first ring 121.
  • the molar anastomosis functional area 11 and the fixture 2 are combined in an embedded mechanical assembly manner.
  • a slot is provided at the position of the fixture 2 corresponding to the drug-carrying functional area 12 to achieve detachable fixation of the fixture 2 and the core component 1.
  • the fixture 2 is made of colorless and transparent polyethylene terephthalate and covers 10 teeth from the left canine to the right second molar in the mandible. After the core component 1 and the fixture 2 are combined, they match part of the mandibular teeth in the subject's mouth.
  • the oral applicator of this embodiment can be firmly worn in the oral cavity after being loaded with tablets, and the tablets are fixed in the oral cavity.
  • the fixator, core component and tablets will not fall off or shift with the movement of the oral cavity. It is very comfortable to wear and has little impact on the facial appearance.
  • This embodiment is an oral drug delivery device covering 7 mandibular teeth, as shown in FIG6 , which includes a core component 1 and a fixing device 2, the fixing device 2 being a fixing device, the core component 1 consisting of a molar anastomosis functional area 11 and a drug-carrying functional area 12, the molar anastomosis functional area 11 can be tightly fitted with the mandibular first and second premolars and the first and second molars in the subject's oral cavity, and the size of the drug-carrying functional area 12 allows it to accommodate at least one tablet and fix the tablet in the oral cavity.
  • the fixing device 2 is tightly fitted with part of the subject's mandibular teeth (including a total of 7 teeth from the right incisor to the right second molar), and is tightly fitted with the molar anastomosis functional area 11, so that the core component 1 and the tablet are fixed in the oral cavity.
  • the molar anastomosis functional area 11 and the drug-carrying functional area 12 are made of cobalt-chromium alloy, and the molar anastomosis functional area 11 and the drug-carrying functional area 12 are connected at their respective sides.
  • the drug-carrying functional area 12 includes a first ring 121 and a second ring 122.
  • the first ring 121 and the second ring 122 are circular closed rings suitable for inserting cylindrical tablets.
  • the tablets are inserted from the second ring 122 and blocked by the first ring 121.
  • the molar anastomosis functional area 11 and the fixture 2 are combined in an embedded mechanical assembly manner.
  • a slot is provided at the position of the fixture 2 corresponding to the drug-carrying functional area 12 to achieve detachable fixation of the fixture 2 and the core component 1.
  • the fixture 2 is made of colorless and transparent ethylene-vinyl acetate copolymer and covers a total of 7 teeth on the right side of the mandible from the incisor to the second molar.
  • the core component 1 and the fixture 2 are combined to match the teeth of the subject.
  • the oral applicator of this embodiment is worn in the oral cavity. After loading the tablets, the tablets can be fixed in the oral cavity and are not easy to fall off.
  • the wearing firmness is not significantly different from that of Examples 1 and 2. At the same time, because the number of teeth covered is small, the wearing comfort and the degree of impact on facial appearance are better than those of Examples 1 and 2.
  • the oral applicator covers all maxillary teeth, and the molar anastomosis functional area 11 can fit tightly with the maxillary second premolars and the first, second and third molars in the oral cavity of the subject, and the rest is the same as embodiment 1.
  • the oral applicator of this embodiment can be firmly worn in the oral cavity after being loaded with tablets, and the tablets are fixed in the oral cavity.
  • the fixator, core component and tablets will not fall off or shift with the movement of the oral cavity. It is very comfortable to wear and has little impact on the facial appearance.
  • the length of the core component 1 is 3 teeth, which can be designed for subjects with molar defects; the first ring 121 and the second ring 122 are polygonal closed loops, and the molar anastomosis functional area 11 and the fixed
  • the device 2 is bonded by using a pressure-sensitive adhesive as an adhesive, the bonding position is the entire outer surface of the molar anastomotic functional area 11, and the adhesive thickness is 0.1 mm;
  • the fixing device 2 is prepared from colorless and transparent ethylene-vinyl acetate copolymer; the rest is the same as Example 1.
  • the oral applicator of this embodiment can be firmly worn in the oral cavity after being loaded with tablets, and the tablets are fixed in the oral cavity.
  • the fixator, core component and tablets will not fall off or shift with the movement of the oral cavity. It is very comfortable to wear and has little impact on the facial appearance.
  • FIG7 The structural schematic diagram of the oral drug delivery device of this embodiment is shown in FIG7 , which includes a core component 1 and a fixing device 2, the fixing device 2 being a fixing layer, and a cross-sectional view of the oral drug delivery device is shown in FIG8 .
  • the core component 1 is composed of a molar anastomosis functional area 11 and a drug-carrying functional area 12, and the molar anastomosis functional area 11 can be tightly fitted with the first and second premolars and the first and second molars of the mandible in the subject's oral cavity.
  • the drug-carrying functional area includes a first ring 121 and a second ring 122, and the first ring 121 and the second ring 122 are circular closed loops, which are suitable for inserting cylindrical tablets, and the tablets are inserted from the second ring 122 and blocked by the first ring 121.
  • the size of the drug-carrying functional area 12 allows it to accommodate at least one tablet and fix the tablet in the oral cavity.
  • the fixing device 2 is attached to the entire outer surface of the first section of the U-shaped structure and the second section of the U-shaped structure; the molar anastomosis functional area 11 and the drug-carrying functional area 12 are made of cobalt-chromium alloy, and the molar anastomosis functional area 11 and the drug-carrying functional area 12 are connected at their respective sides.
  • the fixture 2 is colorless and transparent polyethylene terephthalate, which is softened by heating and covered on the surface of the molar anastomotic functional area 11, and then trimmed of excess material after cooling.
  • the thickness of the fixture 2 is 0.3-0.5 mm, and the core component 1 and the fixture 2 are combined to match the teeth of the subject.
  • the oral applicator of this embodiment can be firmly worn in the oral cavity after being loaded with tablets, and the tablets are fixed in the oral cavity.
  • the fixing layer, core component and tablets will not fall off or shift with the movement of the oral cavity. It is very comfortable to wear and has little impact on the facial appearance.
  • the fixing device 2 is light blue polycaprolactone, and the thickness of the fixing device 2 is 0.8-1 mm, and the rest is the same as embodiment 6.
  • the oral applicator of this embodiment can be worn more firmly in the oral cavity after being loaded with tablets, and the tablets can be fixed in the oral cavity. However, due to the thickness of the fixing device, the oral applicator of this embodiment is not as firmly worn and comfortable as that of embodiment 6. Compared with embodiment 6, this embodiment has a greater impact on facial appearance.
  • the core component 1 and the fixing device 2 are bonded together by using a pressure-sensitive adhesive, the bonding position is the part where the molar anastomotic functional area contacts the teeth, and the thickness of the adhesive is 0.1 mm; the fixing device 2 is a colorless and transparent polypropylene film with a thickness of 0.02 to 0.04 mm; the rest is the same as embodiment 6.
  • the oral medicator of this embodiment can be worn more firmly in the oral cavity after being loaded with tablets, and the tablets can be fixed in the oral cavity.
  • the thickness of the fixing layer is relatively thin and the surface of the fixing layer material is relatively smooth, the wearing firmness and wearing comfort of the oral medicator of this embodiment are not as good as those of Examples 6 and 7.
  • the oral medication device of this embodiment is shown in FIG9 , which includes a core component 1 and a fixing device symmetrical on both sides. 2.
  • the fixing device 2 is a fixture.
  • the two core components 1 are composed of a molar anastomosis functional area 11 and a drug-carrying functional area 12.
  • the molar anastomosis functional area 11 can be tightly fitted with the first and second premolars and the first and second molars in the subject's oral cavity.
  • the size of the drug-carrying functional area 12 allows it to accommodate at least one tablet and fix the tablet in the oral cavity.
  • the fixing device 2 is tightly fitted with all the maxillary teeth of the subject and the molar anastomosis functional area 11, so that the core component 1 and the tablet are fixed in the oral cavity.
  • the molar anastomosis functional area 11 and the drug-carrying functional area 12 are made of cobalt-chromium alloy, and the molar anastomosis functional area 11 and the drug-carrying functional area 12 are connected at their respective sides.
  • the drug-carrying functional area 12 includes a first ring 121 and a second ring 122.
  • the first ring 121 and the second ring 122 are circular closed rings, which are suitable for inserting cylindrical tablets. The tablet is inserted from the second ring 122 and is blocked by the first ring 121.
  • the molar anastomotic functional area 11 and the fixture 2 are combined in an embedded mechanical assembly manner, and a slot is provided on the fixture 2 at a position corresponding to the drug-carrying functional area 12 to achieve detachable fixation of the fixture 2 and the core component 1.
  • the fixture 2 is made of colorless and transparent polyethylene terephthalate and covers all maxillary teeth.
  • the core component 1 and the fixture 2 are combined to match the teeth in the subject's mouth.
  • the oral applicator of this embodiment can be firmly worn in the oral cavity after being loaded with tablets, and the tablets are fixed in the oral cavity.
  • the fixator, core component and tablets will not fall off or shift with the movement of the oral cavity. It is very comfortable to wear and has little impact on the facial appearance.
  • the cobalt-chromium alloy core components were prepared by laser melting and casting, and the fixator was prepared by die-casting. The specific steps are as follows:
  • Step 1 Obtain the oral data of the subject by scanning the subject's oral cavity or taking an oral mold to make a plaster model and then scanning it.
  • Step 2 Use 3D design software and dental design software to respectively design the drug-carrying functional area and molar anastomosis functional area of the core component, and combine them in the dental design software to generate a core component design file.
  • Step 3 Prepare the cobalt-chromium alloy core components by laser melting, grinding, polishing and cleaning.
  • Step 4 Wear the core component on the subject's dental mold, heat and soften the polyethylene terephthalate through a laminator and then draw a vacuum on the dental mold, trim off excess material and polish it, and remove it from the dental mold to obtain the oral applicator, which matches the subject's teeth.
  • the cobalt-chromium alloy core components are prepared by injection molding and the applicator is prepared by die-casting. The specific steps are as follows:
  • Step 1 Make a plaster model by taking a mouth mold of the subject.
  • Step 2 Use dental wax as material to prepare a dental wax model on the plaster model.
  • Step 3 Use cobalt-chromium ceramic alloy as material and prepare core components through traditional injection molding process.
  • Step 4 Wear the core component on the plaster dental model, heat and soften the polyurethane through a laminating machine and then draw a vacuum on the dental model, trim off excess material and polish it, and remove it from the dental model to obtain the oral drug delivery device consisting of the core component and the retainer.
  • the cobalt-chromium alloy core components were prepared by injection molding and the applicator was prepared by the impression method. The specific steps are as follows:
  • Step 1 Make a plaster model by taking a mouth mold of the subject.
  • Step 2 Use dental wax as material to prepare a dental wax model on the plaster model.
  • Step 3 Using cobalt-chromium ceramic alloy as material, prepare the applicator through traditional injection molding process.
  • Step 4 Wear the core component on the corresponding teeth of the subject, heat and soften the polycaprolactone material, cover the molar matching functional area of the subject's teeth and the core component, and remove it from the teeth together with the core component after cooling to obtain the oral applicator.
  • the oral medicator of this comparative example only includes the core component 1 in Example 1, as shown in FIG. 2 .
  • Example 1 The oral applicators of Example 1, Example 3, Example 6 and Comparative Example 1 were tested for wearing firmness, and the wearing firmness scores were as follows in Table 1: 1: not firm, and the applicator is very easy to fall off under basic oral movements such as opening the mouth and talking after wearing; 2: relatively loose, and the applicator sometimes becomes loose, tilted or falls off under basic oral movements such as opening the mouth and talking after wearing; 3: basically firm, and the applicator is easy to fall off only during large-scale oral movements; 4: firm, and the applicator tilts or loosens only during large-scale oral movements, but does not fall off; 5: very firm, and the applicator does not loosen, tilt or fall off during basic or large-scale oral movements.
  • the embodiments 1, 3 and 6 of the present application which combine the fixing device and the core component have better wearing firmness compared with the comparative example 1 which only uses the core component, and the fixing device using a fixer has higher wearing firmness than using a fixing layer.
  • Example 1 extremely uncomfortable, with obvious foreign body sensation or irritation, and unacceptable
  • 2 uncomfortable, with obvious foreign body sensation or irritation, and not quite acceptable
  • 3 with foreign body sensation or irritation, which has a slight effect on oral function, but is acceptable
  • 4 relatively high comfort, with no obvious foreign body sensation or irritation, and basically no effect on oral function
  • 5 high comfort, with almost no foreign body sensation or irritation, and no effect on oral function.
  • Example 1 which only uses the core component
  • Example 3 which combines the fixing device and the core component
  • Example 6 of the present application which combines the fixing device and the core component has a similar degree of influence on the facial appearance when worn
  • the oral applicator of the embodiments of the present application has a similar wearing aesthetics as the comparative example.

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Abstract

本发明公开了一种口腔给药器及其制备方法和应用。该口腔给药器包括核心组件和固定装置，核心组件包括一体成型的磨牙吻合功能区和载药功能区；磨牙吻合功能区包括靠近载药功能区的第一段和远离载药功能区的第二段；第一段和第二段的一端相互连接，另一端为开放端，形成U形结构；第一段和第二段分别用于与牙齿的颊侧和舌侧吻合；载药功能区包括同轴设置的第一环和第二环；固定装置用于加强所述核心组件在牙齿上的固定作用；固定装置为固定器或固定层。该口腔给药器在使用时佩戴牢固性高、安全性高、舒适度高以及对面部外观的影响小。

Description

一种口腔给药器及其制备方法和应用
本申请要求申请日为2023/4/4的中国专利申请2023103663509和申请日为2023/4/4的中国专利申请2023207303692的优先权。本申请引用上述中国专利申请的全文。
技术领域
本发明具体涉及一种口腔给药器及其制备方法和应用。
背景技术
对于左旋多巴、卡比多巴、巴氯芬、阿昔洛韦德等吸收窗口限制在上胃肠道的活性药物成分，常规的缓释制剂存在生物利用度低，治疗覆盖不足的问题。现有的延长药物胃滞留时间的技术(包括扩张、膨胀、漂浮、筏形成、下沉、黏膜粘附)，其延长效果非常有限，特别是在禁食状态下给药时。另外，针对口腔黏膜局部给药，常用的喷雾剂、含漱剂、软膏等液体或半固体制剂在口腔内停留时间短，不能达到持续给药效果。因此，需要一种能提供长时间药物成分暴露的给药系统，适用于吸收窗口在上胃肠道或需要口腔局部给药的药物。通过给药器装载药物，并与固定器组合后固定在口腔中，形成药物控释系统，提供吸收窗口限制在上胃肠道的药物的长时间暴露。
关于口腔内给药装置，专利申请US10668274和CN1997421A公开了一种基于电动控制药物释放机理的口腔含药装容器，该专利声称的含药容器和电动控制系统实施困难。CN105873631A公开了一种口腔药物递送装置，需要以电子泵或机械泵作为外部动力实现给药。另外，CN1925823A公开了一种牙齿托架，用于将氟化物药丸体附着于牙齿，以提高龋齿的治疗或预防，该专利申请不涉及上胃肠道的药物吸收。另外，专利申请CN109908461A公开了一种应用于义齿、牙套或口腔种植体的口腔给药装置，适用于口腔黏膜给药，不涉及上胃肠道的药物吸收。以上已公开的专利申请中或需要外部动力，或需要依靠义齿、牙套等实现，或未涉及吸收端在上胃肠道的药物吸收。
CN114191307A和CN212973560U中公开了一种口腔滞留装置，用于将药片滞留于口腔，提供吸收窗口限制在上胃肠道的药物的长时间暴露，以获取长期稳定的血药浓度。该口腔滞留装置已考虑到药片从后向前插入，靠近咽喉处且有颊脂垫尖等口腔组织阻挡，在佩戴装置时药片不易脱落。同时，该口腔滞留装置中的牙齿吻合构件根据个性化的设计能与患者牙齿贴合，使其佩戴稳固。但对于临床牙冠过短、颊侧空间小或口腔状况较特殊的患者，在口腔动作幅度大时，可能造成口腔滞留装置固位欠佳，有翘起或脱落的风险。
以上口腔内给药装置未考虑特殊口腔状况下的佩戴牢固性，以及复杂结构或较大的装置体积可能造成患者佩戴舒适性、安全性较差，同时还会在佩戴时对面部外观有较大的影响。
发明内容
为了解决现有技术中部分患者佩戴给药器在大幅度张口等动作后，给药器有脱落风险的问题，本发明提供了一种口腔给药器及其制备方法和应用。具体地，本发明中提供了一种药片由后向前插入的口腔给药器，其由核心组件和固定装置组成，能够使口腔给药器和药片稳定地保持在口腔中，不会随口腔动作而脱落。针对吸收窗口限制在胃肠道上端的药物的长时间释放，以及口腔黏膜给药或作用于口腔局部的药物释放，患者佩戴该给药器都可以实现，同时，该口腔给药器在使用时的舒适度高以及对面部外观的影响小。
本发明主要采用以下技术方案解决上述技术问题：
本发明提供了一种口腔给药器，其包括核心组件和固定装置，所述核心组件包括一体成型的磨牙吻合功能区和载药功能区；
所述口腔给药器在口腔中固定时，所述载药功能区位于牙齿和脸颊之间的空间内，或者，所述载药功能区位于牙齿和舌头之间的空间内；
所述磨牙吻合功能区包括靠近所述载药功能区的第一段和远离所述载药功能区的第二段；所述第一段和所述第二段的一端相互连接，另一端为开放端，形成U形结构；所述第一段和第二段分别用于与牙齿的颊侧和舌侧吻合，用于将所述载药功能区固定在牙齿上；
所述载药功能区包括同轴设置的第一环和第二环；所述第一环和所述第二环之间形成的轴向夹持空间用于固定药物；
所述固定装置为固定器或固定层，用于加强所述核心组件在牙齿上的固定作用；
当所述固定装置为固定器时：
所述口腔给药器在使用时，所述固定器的舌侧、颊侧和咬合面对应地与牙齿的舌侧、颊侧和咬合面吻合并包覆在牙齿的外周面上；所述固定器同时包覆住所述磨牙吻合功能区；
当所述固定装置为固定层时：
所述固定层贴设于所述第一段和所述第二段中用于与牙齿接触的外表面。
本发明中，所述第一环和所述第二环较佳地位于第一或第二磨牙的颊侧。
本发明中，所述固定器与所述磨牙吻合功能区较佳地通过机械组装、机械连接或胶黏剂粘接的方式连接。
其中，所述机械组装较佳地为嵌入，所述固定器上对应所述载药功能区的位置处开设有槽孔，以实现所述固定器与所述核心组件的可拆卸固定，所述嵌入的含义为所述磨牙吻合功能区嵌入所述固定器两侧形成的空间内。
其中，所述机械连接较佳地为焊接、铆接或栓接。
其中，所述胶黏剂较佳地为压敏胶、淀粉胶、乳胶、环氧树脂和聚氨酯丙烯酸酯中的一种或多种。
本发明中，所述固定层较佳地还贴设于所述第一段和所述第二段的其他外表面。
本发明中，所述第一环靠近所述磨牙吻合功能区的开放端，所述第二环远离所述磨 牙吻合功能区的开放端，所述第一环和所述第二环较佳地为实心或镂空的环状结构。
其中，所述镂空的环状结构为闭环或开环。
其中，所述环状结构的形状较佳地为圆形、椭圆形和多边形中的一种或多种。
其中，所述第一环和所述第二环的环状结构的形状较佳地均为圆形；所述第一环的镂空面积较佳地比所述第二环的镂空面积小，药片可由第二环插入到第一环处。
本发明中，所述核心组件的材质较佳地为钛、不锈钢、钴铬合金、钴铬钼合金或贵金属中的一种，更佳地为钴铬合金，所述核心组件的材质均符合牙科使用材质的标准。
本发明中，所述固定器的材质较佳地为聚氯乙烯、聚对苯二甲酸乙二醇酯、聚对苯二甲酸乙二醇酯-1,4-环己烷二甲醇酯、聚氨酯、聚酰胺、乙烯-醋酸乙烯共聚物、聚己内酯、高密度聚乙烯、聚丙烯、环氧丙烯酸酯、甲基丙烯酸酯、聚氨酯丙烯酸酯中的一种或多种；更佳地为聚对苯二甲酸乙二醇酯或乙烯-醋酸乙烯共聚物，所述固定器的材质均符合医用级标准。
本发明中，所述固定层的材质较佳地为聚氯乙烯、聚对苯二甲酸乙二醇酯、聚对苯二甲酸乙二醇酯-1,4-环己烷二甲醇酯、聚氨酯、聚酰胺、乙烯-醋酸乙烯共聚物、聚己内酯、高密度聚乙烯、聚丙烯、醋酸纤维素、羟丙基纤维素和共聚维酮中的一种或多种，更佳地为聚对苯二甲酸乙二醇酯或共聚维酮，所述固定层的材质均符合医用级标准。
本发明中，所述固定层的厚度较佳地为0.01mm-1mm。
本发明中，所述固定器覆盖牙齿的数量可以根据牙齿情况和佩戴牢固性调整，所述固定器的长度较佳地为对应于上颌或下颌4～16颗牙的长度，更佳地为对应于上颌或下颌5～9颗牙的长度。
本发明中，所述磨牙吻合功能区的长度较佳地为对应于下颌2～5颗牙的长度。
其中，本领域技术人员应当理解，所述长度为使所述固定器或所述磨牙吻合功能区能够包覆住所述牙齿数量的长度，且不会超过目标范围的牙齿数量。
在某一优选的实施例中，所述固定器与所述磨牙吻合功能区以嵌入的方式连接，所述固定器上对应所述载药功能区的位置处开设有槽孔，以实现所述固定器与所述核心组件的可拆卸固定；所述磨牙吻合功能区的长度为对应于下颌第一、第二前磨牙和第一、第二磨牙的长度；所述第一环和第二环为圆形闭环。
在某一优选的实施例中，所述固定器与所述磨牙吻合功能区以嵌入的方式连接；所述磨牙吻合功能区的长度为对应于下颌第一、第二前磨牙和第一、第二磨牙的长度；所述第一环和第二环为椭圆形闭环。
在某一优选的实施例中，所述固定器与所述磨牙吻合功能区以嵌入的方式连接；所述磨牙吻合功能区的长度为对应于上颌第二前磨牙和第一、第二、第三磨牙的长度，所述第一环和第二环为圆形闭环。
在某一优选的实施例中，所述固定器与所述磨牙吻合功能区以压敏胶为胶黏剂的粘接方式连接；所述磨牙吻合功能区的长度为对应于第一、第二、第三磨牙的长度；所述第一环和第二环为多边形闭环。
在某一优选的实施例中，所述固定层贴设于所述U形结构的第一段和所述U形结构的第二段的全部外表面；所述磨牙吻合功能区的长度为对应于下颌第一、第二前磨牙和第一、第二磨牙的长度；所述第一环和第二环为圆形闭环。
在某一优选的实施例中，在所述第一环上沿所述磨牙吻合功能区的开放端的方向，对称设有一对夹持壁。
本发明还提供了一种上述口腔给药器的制备方法，其包括以下步骤：当所述固定装置为固定器时，将所述固定器与一体成型的所述第一段和所述第二段以包覆的形式结合；当所述固定装置为固定层时，将所述固定层贴设于一体成型的所述第一段和所述第二段的外表面。
本发明中，所述核心组件的制备方法较佳地包括激光熔铸、注塑成型或印模成型。
其中，所述激光熔铸的步骤较佳地为：对受试者口腔扫描或取口模制作石膏模型后扫描，得到受试者口腔数据；使用三维设计软件和齿科设计软件分别设计核心组件的载药功能区和磨牙吻合功能区，并在齿科设计软件中结合，生成核心组件设计文件；通过激光熔铸、打磨、抛光、清洁制备核心组件。
其中，所述注塑成型的步骤较佳地为：对受试者取口模，制作石膏模型；以牙蜡为材料，在石膏模型上制备牙蜡模型，通过传统注塑工艺制备核心组件。
本发明中，所述固定器的制备方法较佳地包括压膜、印模、切削或3D打印。
其中，所述压膜的步骤较佳地为：将所述固定器的原材料通过压膜机加热软化后抽真空，使所述固定器的原材料覆盖在牙模和所述磨牙吻合功能区上。
其中，所述印模的步骤较佳地为：将所述固定器的原材料加热软化，覆盖在受试者牙齿和所述磨牙吻合功能区上。
本发明中，所述固定器的原材料较佳地如前所述。
本发明中，所述固定层的制备方法较佳地包括浸涂、喷涂或压膜。
其中，所述浸涂的步骤较佳地为：将所述固定层的原材料溶解后，将所述磨牙吻合功能区浸入固定层的原材料溶液，取出，干燥成膜即可。
其中，所述喷涂的步骤较佳地为：将所述固定层的原材料溶解后通过喷雾的方式涂布到所述磨牙吻合功能区，干燥成膜后即可。
其中，所述压膜的步骤较佳地为：将所述固定层的原材料加热软化后，覆盖所述磨牙吻合功能区后冷却。
本发明中，所述固定层的原材料较佳地如前所述。
本发明中，所述固定器与所述第一段和所述第二段的包覆结构的形成方式较佳地为机械组装、机械连接或胶黏剂粘接。
其中，所述机械组装的形式较佳地为嵌入。
当所述组合方式为机械组装时，固定器在成型过程中与牙模和核心组件贴合，自然形成类似卡槽样的结构，同时可根据需要在所述磨牙吻合功能区上增加卡扣设计。
其中，所述机械连接的形式较佳地为焊接、铆接或栓接。
其中，所述胶黏剂的涂布位置较佳地为所述第一段和所述第二段中用于与牙齿接触的外表面，更佳地为所述第一段和所述第二段的全部外表面。
其中，所述胶黏剂的涂布厚度较佳地为不超过1.0mm。
本发明还提供了一种上述口腔给药器的应用，其特征在于：当所述固定装置为固定器时：将所述固定器的舌侧、颊侧和咬合面对应地与牙齿的舌侧、颊侧和咬合面吻合并包覆在牙齿的外周面上；将所述载药功能区置于牙齿和脸颊之间的空间内，或者，将所述载药功能区置于牙齿和舌头之间的空间内；并用所述固定器包覆住所述磨牙吻合功能区；
当所述固定装置为固定层时：将所述载药功能区置于牙齿和脸颊之间的空间内，或者，将所述载药功能区置于牙齿和舌头之间的空间内。
在符合本领域常识的基础上，上述各优选条件，可任意组合，即得本发明各较佳实例。
本发明所用试剂和原料均市售可得。
本发明的积极进步效果在于：
本发明提供了一种与口腔中牙齿相吻合的，极低脱落风险的口腔给药器。将药片从后侧向前插入给药器的载药功能区，将组合药片后的口腔给药器固定于口腔中相应的牙齿上，可以实现药物的持续释放，药物包括但不限于吸收窗口限制在上胃肠道的药物和作用于口腔局部的药物。
本发明中的口腔给药器不需要外部动力，也不需要对患者牙齿做调整，佩戴操作简便。本申请的口腔给药器佩戴牢固性高，即安全性高，可以避免出现给药器松动脱落造成的误吞或呛咳；本申请的口腔给药器在佩戴时对患者面部外观的影响小，佩戴美观程度高；同时该口腔给药器还具有高舒适度。
附图说明
图1为本发明实施例1的口腔给药器各部件结构示意图，其由核心组件1和固定装置2组成，其中，核心组件1包含磨牙吻合功能区11和载药功能区12，载药功能区12由第一环121和第二环122组成。
图2为本发明实施例1的口腔给药器中核心组件的结构示意图。
图3为本发明实施例1的口腔给药器中固定装置为固定器时的固定器结构示意图。
图4为沿图1的A-A面的剖面图。
图5为实施例2的口腔给药器的结构示意图。
图6为实施例3的口腔给药器的结构示意图。
图7为实施例6的口腔给药器的结构示意图。
图8为沿图7的B-B面的剖面图。
图9为实施例9的口腔给药器的结构示意图。
附图标记说明如下：
1-核心组件；2-固定装置；201-固定装置的舌侧；202-固定装置的颊侧；203-固定装
置的咬合面；11-磨牙吻合功能区；12-载药功能区；121-第一环；122-第二环；123-夹持壁。
具体实施方式
下面通过实施例的方式进一步说明本发明，但并不因此将本发明限制在所述的实施例范围之中。下列实施例中未注明具体条件的实验方法，按照常规方法和条件，或按照商品说明书选择。
实施例1
本实施例为覆盖全部下颌牙的口腔给药器，如图1所示，其包括核心组件1和固定装置2，固定装置2为固定器，核心组件1结构示意图如图2所示，固定装置2的结构示意图如图3所示，口腔给药器的剖面图如图4所示。固定装置的舌侧201、固定装置的颊侧202和固定装置的咬合面203对应地与牙齿的舌侧、颊侧和咬合面吻合并包覆在牙齿的外周面上；固定装置2同时包覆住磨牙吻合功能区11。核心组件1由磨牙吻合功能区11和载药功能区12组成，磨牙吻合功能区11可与受试者口腔内的下颌第一、第二前磨牙和第一、第二磨牙密合，载药功能区12的尺寸使其可容纳至少一药片，并使药片固定于口腔中。固定装置2与受试者的全部下颌牙齿密合，并与磨牙吻合功能区11密合，使核心组件1和药片固定在口腔中。磨牙吻合功能区11和载药功能区12由钴铬合金制备而得，磨牙吻合功能区11和载药功能区12于各自的侧部相连接。载药功能区12包括第一环121和第二环122，第一环121和第二环122为圆形闭环，药片从第二环122插入，被第一环121挡住。磨牙吻合功能区11和固定装置2以嵌入的机械组装方式结合，固定装置2上对应载药功能区12的位置处开设有槽孔，以实现固定装置2与核心组件1的可拆卸固定。固定装置2由无色透明的聚对苯二甲酸乙二醇酯制备得到，并覆盖全部下颌牙，即覆盖14颗牙，核心组件1与固定装置2组合后与受试者口腔内的牙齿匹配。
本实施例的口腔给药器装载药片后能在口腔中佩戴牢固，并使药片固定在口腔中，且固定器、核心组件和药片均不会随口腔动作而脱落或移位，佩戴舒适程度高，且对面部外观的影响程度小。
实施例2
本实施例为覆盖10颗下颌牙的口腔给药器，如图5所示，其包括核心组件1和固定装置2，固定装置2为固定器，核心组件1由磨牙吻合功能区11和载药功能区12组成，磨牙吻合功能区11可与受试者口腔内的下颌第一、第二前磨牙和第一、第二磨牙密合，载药功能区12的尺寸使其可容纳至少一药片，并使药片固定于口腔中。固定装置2与受试者的部分下颌牙齿(包括从左侧尖牙到右侧第二磨牙的牙齿)密合，并与磨牙吻合功能区11密合，使核心组件1和药片固定在口腔中。磨牙吻合功能区11和载药功能区12由钴铬合金制备而得，磨牙吻合功能区11和载药功能区12于各自的侧部相连接。载药功能区12包括第一环121和第二环122，第一环121和第二环122为椭圆形闭环，在第 一环121上沿磨牙吻合功能区的开放端的方向，对称设有一对夹持壁123，适用于非圆柱体形状的药片插入，药片从第二环122插入，被第一环121挡住。磨牙吻合功能区11和固定装置2以嵌入的机械组装方式结合，固定装置2上对应载药功能区12的位置处开设有槽孔，以实现固定装置2与核心组件1的可拆卸固定。固定装置2由无色透明的聚对苯二甲酸乙二醇酯制备得到，并覆盖下颌从左侧尖牙到右侧第二磨牙的10颗牙齿，核心组件1与固定装置2组合后与受试者口腔内的部分下颌牙匹配。
本实施例的口腔给药器装载药片后能在口腔中佩戴牢固，并使药片固定在口腔中，且固定器、核心组件和药片均不会随口腔动作而脱落或移位，佩戴舒适程度高，且对面部外观的影响程度小。
实施例3
本实施例为覆盖7颗下颌牙的口腔给药器，如图6所示，其包括核心组件1和固定装置2，固定装置2为固定器，核心组件1由磨牙吻合功能区11和载药功能区12组成，磨牙吻合功能区11可与受试者口腔内的下颌第一、第二前磨牙和第一、第二磨牙密合，载药功能区12的尺寸使其可容纳至少一药片，并使药片固定于口腔中。固定装置2与受试者的部分下颌牙齿(包括从右侧切牙到右侧第二磨牙的共7颗牙齿)密合，并与磨牙吻合功能区11密合，使核心组件1和药片固定在口腔中。磨牙吻合功能区11和载药功能区12由钴铬合金制备而得，磨牙吻合功能区11和载药功能区12于各自的侧部相连接。载药功能区12包括第一环121和第二环122，第一环121和第二环122为圆形闭环，适用于圆柱体形状的药片插入，药片从第二环122插入，被第一环121挡住。磨牙吻合功能区11和固定装置2以嵌入的机械组装方式结合，固定装置2上对应载药功能区12的位置处开设有槽孔，以实现固定装置2与核心组件1的可拆卸固定。固定装置2由无色透明的乙烯-醋酸乙烯共聚物制备得到，并覆盖下颌右侧从切牙到第二磨牙的共7颗牙齿，核心组件1与固定装置2组合后与受试者牙齿匹配。
在口腔中佩戴本实施例的口腔给药器，装载药片后能使药片固定在口腔中不易脱落，佩戴牢固程度与实施例1和2无明显差别，同时因为覆盖牙齿数量少，其佩戴舒适度和对面部外观的影响程度相较于实施例1和2更好。
实施例4
本实施例与实施例1的区别在于口腔给药器覆盖全部上颌牙，且磨牙吻合功能区11可与受试者口腔内的上颌第二前磨牙和第一、第二、第三磨牙密合，其余均与实施例1相同。
本实施例的口腔给药器装载药片后能在口腔中佩戴牢固，并使药片固定在口腔中，且固定器、核心组件和药片均不会随口腔动作而脱落或移位，佩戴舒适程度高，且对面部外观的影响程度小。
实施例5
本实施例与实施例1的区别在于核心组件1的长度为3颗牙齿，可针对有磨牙缺损情况的受试者设计；第一环121和第二环122为多边形闭环，磨牙吻合功能区11和固定 装置2以压敏胶为胶黏剂的粘接方式结合，粘接位置为磨牙吻合功能区11的全部外表面，胶黏剂厚度为0.1mm；固定装置2由无色透明的乙烯-醋酸乙烯共聚物制备得到；其余均与实施例1相同。
本实施例的口腔给药器装载药片后能在口腔中佩戴牢固，并使药片固定在口腔中，且固定器、核心组件和药片均不会随口腔动作而脱落或移位，佩戴舒适程度高，且对面部外观的影响程度小。
实施例6
本实施例的口腔给药器的结构示意图如图7所示，其包括核心组件1和固定装置2，固定装置2为固定层，口腔给药器的剖面图如图8所示。核心组件1由磨牙吻合功能区11和载药功能区12组成，磨牙吻合功能区11可与受试者口腔内的下颌第一、第二前磨牙和第一、第二磨牙密合。载药功能区包括第一环121和第二环122，第一环121和第二环122为圆形闭环，适用于圆柱体形状的药片插入，药片从第二环122插入，被第一环121挡住。载药功能区12的尺寸使其可容纳至少一药片，并使药片固定于口腔中。固定装置2贴设于U形结构的第一段和U形结构的第二段的全部外表面；磨牙吻合功能区11和载药功能区12由钴铬合金制备而得，磨牙吻合功能区11和载药功能区12于各自的侧部相连接。固定装置2为无色透明的聚对苯二甲酸乙二醇酯，通过加热软化后覆盖到磨牙吻合功能区11的表面，冷却后修剪多余材料得到。固定装置2厚度为0.3～0.5mm，核心组件1与固定装置2组合后与受试者牙齿匹配。
本实施例的口腔给药器装载药片后能在口腔中佩戴牢固，并使药片固定在口腔中，且固定层、核心组件和药片均不会随口腔动作而脱落或移位，佩戴舒适程度高，且对面部外观的影响程度小。
实施例7
本实施例与实施例6的区别在于固定装置2为浅蓝色的聚己内酯，且固定装置2的厚度为0.8～1mm，其余均与实施例6相同。
本实施例的口腔给药器装载药片后能在口腔中佩戴较稳固，并使药片固定在口腔中，但因为固定装置厚度较厚，本实施例中的口腔给药器佩戴牢固程度和佩戴舒适程度均不如实施例6，且与实施6相比，本实施例对面部外观的影响程度更大。
实施例8
本实施例与实施例6的区别在于核心组件1和固定装置2以压敏胶为胶黏剂粘接的方式结合，粘接位置为磨牙吻合功能区与牙齿接触的部分，胶黏剂厚度为0.1mm；固定装置2为无色透明的聚丙烯膜，厚度为0.02～0.04mm；其余均与实施例6相同。
本实施例的口腔给药器装载药片后能在口腔中佩戴较稳固，并使药片固定在口腔中，但因为固定层厚度较薄且固定层材料表面较光滑，本实施例中的口腔给药器佩戴牢固性和佩戴舒适程度不如实施例6和7。
实施例9
本实施例的口腔给药器如图9所示，其包括左右两侧对称的核心组件1和固定装置 2，固定装置2为固定器，两个核心组件1由磨牙吻合功能区11和载药功能区12组成，磨牙吻合功能区11可与受试者口腔内的上颌第一、第二前磨牙和第一、第二磨牙密合，载药功能区12的尺寸使其可容纳至少一药片，并使药片固定于口腔中。固定装置2与受试者的全部上颌牙齿密合，并与磨牙吻合功能区11密合，使核心组件1和药片固定在口腔中。磨牙吻合功能区11和载药功能区12由钴铬合金制备而得，磨牙吻合功能区11和载药功能区12于各自的侧部相连接。载药功能区12包括第一环121和第二环122，第一环121和第二环122为圆形闭环，适用于圆柱体形状的药片插入，药片从第二环122插入，被第一环121挡住。磨牙吻合功能区11和固定装置2以嵌入的机械组装方式结合，固定装置2上对应载药功能区12的位置处开设有槽孔，以实现固定装置2与核心组件1的可拆卸固定。固定装置2由无色透明的聚对苯二甲酸乙二醇酯制备得到，并覆盖全部上颌牙，核心组件1与固定装置2组合后与受试者口腔内的牙齿匹配。
本实施例的口腔给药器装载药片后能在口腔中佩戴牢固，并使药片固定在口腔中，且固定器、核心组件和药片均不会随口腔动作而脱落或移位，佩戴舒适程度高，且对面部外观的影响程度小。
实施例10
采用激光熔铸法制备钴铬合金核心组件和压膜法制备固定器，具体步骤如下：
步骤1：通过对受试者口腔扫描或取口模制作石膏模型后扫描，得到受试者口腔数据。
步骤2：使用三维设计软件和齿科设计软件分别设计核心组件的载药功能区和磨牙吻合功能区，并在齿科设计软件中结合，生成核心组件设计文件。
步骤3：通过激光熔铸、打磨、抛光、清洁制备钴铬合金核心组件。
步骤4：将核心组件佩戴在受试者牙模上，将聚对苯二甲酸乙二醇酯通过压膜机加热软化后在牙模上抽真空，修剪去多余材料并打磨，从牙模上取下即得到口腔给药器，口腔给药器与受试者牙齿匹配。
实施例11
采用注塑成型制备钴铬合金核心组件和压膜法制备给药器，具体步骤如下：
步骤1：通过对受试者取口模，制作石膏模型。
步骤2：以牙蜡为材料，在石膏模型上制备牙蜡模型。
步骤3：以钴铬烤瓷合金为材料，通过传统注塑工艺制备核心组件。
步骤4：将核心组件佩戴在石膏牙模上，将聚氨酯通过压膜机加热软化后在牙模上抽真空，修剪去多余材料并打磨，从牙模上取下即得到核心组件和固定器组合的口腔给药器。
实施例12
采用注塑成型制备钴铬合金核心组件和印模法制备给药器，具体步骤如下：
步骤1：通过对受试者取口模，制作石膏模型。
步骤2：以牙蜡为材料，在石膏模型上制备牙蜡模型。
步骤3：以钴铬烤瓷合金为材料，通过传统注塑工艺制备给药器。
步骤4：将核心组件佩戴在受试者对应的牙齿上，将聚己内酯材料加热软化，覆盖在受试者牙齿和核心组件的磨牙吻合功能区上，待冷却后和核心组件一起从牙齿上取下，即得到口腔给药器。
对比例1
本对比例的口腔给药器仅包括实施例1中的核心组件1，如图2所示。
效果实施例1
对实施例1、实施例3、实施例6和对比例1的口腔给药器进行佩戴牢固性测试，佩戴牢固性评分如下表1：其中，1分为不牢固，佩戴后在张口、说话等基本口腔动作下极易脱落；2分为较不牢固，佩戴后在张口、说话等基本口腔动作下有时会松动、翘起或脱落；3分为基本牢固，仅大幅度口腔动作时容易脱落；4分为牢固，仅大幅度口腔动作时有翘起或松动，但无脱落；5分为非常牢固，基本口腔动作或大幅度口腔动作时均无松动、翘起或脱落。
表1
由表1可知，本申请实施例1、实施例3、实施例6采用将固定装置和核心组件组合的方式与对比例1仅采用核心组件相比，佩戴牢固性更好，且固定装置采用固定器比采用固定层的佩戴牢固性更高。
效果实施例2
对实施例1、实施例3、实施例6和对比例1的口腔给药器进行佩戴舒适度测试，佩戴舒适度评分如下表2：其中，1分为极不舒适，异物感或刺激性明显，不可接受；2分为不舒适，异物感或刺激性较明显，不太能接受；3分为有异物感或刺激性，对口腔功能略有影响，但可接受；4分为舒适度较高，异物感或刺激性不明显，对口腔功能基本无影响；5分为舒适度高，几乎无异物感或刺激性，对口腔功能无影响。
表2

由表2可知，本申请实施例1、实施例3、实施例6采用将固定装置和核心组件组合的方式与对比例1仅采用核心组件相比，佩戴舒适度更好。
效果实施例3
测试实施例1、实施例3、实施例6和对比例1的口腔给药器佩戴时对面部外观的影响程度，评分如下表3：其中，1分为对面部外观的影响程度最大，不可接受；2分为对面部外观的影响程度较大，不太能接受；3分为对面部外观有影响，但可接受；4分为对面部外观影响小；5分为佩戴前后的面部外观几乎无差别。
表3
由上表可知，本申请实施例1、实施例3、实施例6采用将固定装置和核心组件组合的方式与对比例1仅采用核心组件相比，口腔给药器佩戴时对面部外观的影响程度接近，即本申请实施例的口腔给药器与对比例相比具有相近的佩戴美观度。
虽然以上描述了本发明的具体实施方式，但是本领域的技术人员应当理解，这些仅是举例说明，在不背离本发明的原理和实质的前提下，可以对这些实施方式做出多种变更或修改。因此，本发明的保护范围由所附权利要求书限定。

Claims (10)

  1. 一种口腔给药器，其特征在于，其包括核心组件和固定装置，所述核心组件包括一体成型的磨牙吻合功能区和载药功能区；
    所述口腔给药器在口腔中固定时，所述载药功能区位于牙齿和脸颊之间的空间内，或者，所述载药功能区位于牙齿和舌头之间的空间内；
    所述磨牙吻合功能区包括靠近所述载药功能区的第一段和远离所述载药功能区的第二段；所述第一段和所述第二段的一端相互连接，另一端为开放端，形成U形结构；所述第一段和所述第二段分别用于与牙齿的颊侧和舌侧吻合，用于将所述载药功能区固定在牙齿上；
    所述载药功能区包括同轴设置的第一环和第二环；所述第一环和所述第二环之间形成的轴向夹持空间用于固定药物；
    所述固定装置为固定器或固定层，用于加强所述核心组件在牙齿上的固定作用；
    当所述固定装置为固定器时：
    所述口腔给药器在使用时，所述固定器的舌侧、颊侧和咬合面对应地与牙齿的舌侧、颊侧和咬合面吻合并包覆在牙齿的外周面上；所述固定器同时包覆住所述磨牙吻合功能区；
    当所述固定装置为固定层时：
    所述固定层贴设于所述第一段和所述第二段中用于与牙齿接触的外表面。
  2. 如权利要求1所述的口腔给药器，其特征在于，所述固定器与所述磨牙吻合功能区通过机械组装、机械连接或胶黏剂粘接的方式连接；
    和/或，所述固定层还贴设于所述第一段和所述第二段的其他外表面；
    和/或，所述第一环靠近所述磨牙吻合功能区的开放端，所述第二环远离所述磨牙吻合功能区的开放端，所述第一环和所述第二环为实心或镂空的环状结构。
  3. 如权利要求2所述的口腔给药器，其特征在于，所述机械组装为嵌入，所述固定器上对应所述载药功能区的位置处开设有槽孔，以实现所述固定器与所述核心组件的可拆卸固定；
    和/或，所述机械连接为焊接、铆接或栓接；
    和/或，所述胶黏剂为压敏胶、淀粉胶、乳胶、环氧树脂和聚氨酯丙烯酸酯中的一种或多种；
    和/或，所述镂空的环状结构为闭环或开环；
    和/或，所述环状结构的形状为圆形、椭圆形和多边形中的一种或多种；
    和/或，所述第一环和所述第二环的环状结构的形状均为圆形；所述第一环的镂空面积比所述第二环的镂空面积小。
  4. 如权利要求1-3中至少一项所述的口腔给药器，其特征在于，所述核心组件的材质为钛、不锈钢、钴铬合金、钴铬钼合金或贵金属中的一种，较佳地为钴铬合金；
    和/或，所述固定器的材质为聚氯乙烯、聚对苯二甲酸乙二醇酯、聚对苯二甲酸乙二醇酯-1,4-环己烷二甲醇酯、聚氨酯、聚酰胺、乙烯-醋酸乙烯共聚物、聚己内酯、聚乙烯、聚丙烯、环氧丙烯酸酯、甲基丙烯酸酯、聚氨酯丙烯酸酯中的一种或多种；较佳地为聚对苯二甲酸乙二醇酯或乙烯-醋酸乙烯共聚物；
    和/或，所述固定器的长度为对应于上颌或下颌4～16颗牙的长度，较佳地为对应于上颌或下颌5～9颗牙的长度；
    和/或，所述磨牙吻合功能区的长度为对应于下颌2～5颗牙的长度。
  5. 如权利要求1-4中至少一项所述的口腔给药器，其特征在于，所述固定层的材质为聚氯乙烯、聚对苯二甲酸乙二醇酯、聚对苯二甲酸乙二醇酯-1,4-环己烷二甲醇酯、聚氨酯、聚酰胺、乙烯-醋酸乙烯共聚物、聚己内酯、高密度聚乙烯、聚丙烯、醋酸纤维素、羟丙基纤维素和共聚维酮中的一种或多种；较佳地为聚对苯二甲酸乙二醇酯或共聚维酮；
    和/或，所述固定层的厚度为0.01mm-1mm。
  6. 如权利要求1-5中至少一项所述的口腔给药器，其特征在于，所述固定器与所述磨牙吻合功能区以嵌入的方式连接；所述磨牙吻合功能区的长度为对应于下颌第一、第二前磨牙和第一、第二磨牙的长度；所述第一环和第二环为圆形闭环；
    或者，所述固定器与所述磨牙吻合功能区以嵌入的方式连接；所述磨牙吻合功能区的长度为对应于下颌第一、第二前磨牙和第一、第二磨牙的长度；所述第一环和第二环为椭圆形闭环；
    或者，所述固定器与所述磨牙吻合功能区以嵌入的方式连接；所述磨牙吻合功能区的长度为对应于上颌第二前磨牙和第一、第二、第三磨牙的长度，所述第一环和第二环为圆形闭环；
    或者，所述固定器与所述磨牙吻合功能区以压敏胶为胶黏剂的粘接方式连接；所述磨牙吻合功能区的长度为对应于第一、第二、第三磨牙的长度；所述第一环和第二环为多边形闭环；
    或者，所述固定层贴设于所述U形结构的第一段和所述U形结构的第二段的全部外表面；所述磨牙吻合功能区的长度为对应于下颌第一、第二前磨牙和第一、第二磨牙的长度；所述第一环和第二环为圆形闭环；
    或者，在所述第一环上沿所述磨牙吻合功能区的开放端的方向，对称设有一对夹持壁。
  7. 一种如权利要求1-6中至少一项所述的口腔给药器的制备方法，其特征在于，其包括以下步骤：当所述固定装置为固定器时，将所述固定器与一体成型的所述第一段和所述第二段以包覆的形式结合；当所述固定装置为固定层时，将所述固定层贴设于一体成型的所述第一段和所述第二段的外表面。
  8. 如权利要求7所述的口腔给药器的制备方法，其特征在于，所述核心组件的制备方法包括激光熔铸、注塑成型或印模成型；
    和/或，所述固定器的制备方法包括压膜、印模、切削或3D打印；
    和/或，所述固定层的制备方法包括浸涂、喷涂或压膜；
    和/或，所述固定器与所述第一段和所述第二段的包覆结构的形成方式为机械组装、机械连接或胶黏剂粘接。
  9. 如权利要求7和/或8所述的口腔给药器的制备方法，其特征在于，所述固定器的制备方法中：
    所述压膜的步骤为：将所述固定器的原材料通过压膜机加热软化后抽真空，使所述固定器的原材料覆盖在牙模和所述磨牙吻合功能区上；
    或者，所述印模的步骤为：将所述固定器的原材料加热软化，覆盖在受试者牙齿和所述磨牙吻合功能区上；
    和/或，所述固定层的制备方法中：
    所述浸涂的步骤为：将所述固定层的原材料溶解后，将所述磨牙吻合功能区浸入固定层的原材料溶液，取出，干燥成膜即可；
    或者，所述喷涂的步骤为：将所述固定层的原材料溶解后通过喷雾的方式涂布到所述磨牙吻合功能区，干燥成膜后即可；
    或者，所述压膜的步骤为：将所述固定层的原材料加热软化后，覆盖所述磨牙吻合功能区后冷却；
    和/或，所述机械组装的形式为嵌入；
    和/或，所述机械连接的形式为焊接、铆接或栓接；
    和/或，所述胶黏剂的涂布位置为所述第一段和所述第二段中用于与牙齿接触的外表面，较佳地为所述第一段和所述第二段的全部外表面；
    和/或，所述胶黏剂的涂布厚度不超过1.0mm。
  10. 一种如权利要求1-6中至少一项所述的口腔给药器的应用，其特征在于：
    当所述固定装置为固定器时：将所述固定器的舌侧、颊侧和咬合面对应地与牙齿的舌侧、颊侧和咬合面吻合并包覆在牙齿的外周面上；将所述载药功能区置于牙齿和脸颊之间的空间内，或者，将所述载药功能区置于牙齿和舌头之间的空间内；并用所述固定器包覆住所述磨牙吻合功能区；
    当所述固定装置为固定层时：将所述载药功能区置于牙齿和脸颊之间的空间内，或者，将所述载药功能区置于牙齿和舌头之间的空间内。
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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040158194A1 (en) * 2003-02-06 2004-08-12 Wolff Andy And Beiski Ben Z. Oral devices and methods for controlled drug release
CN105873631A (zh) * 2013-11-05 2016-08-17 辛纳吉勒公司 经由口腔进行连续药物递送的装置和方法
CN106137764A (zh) * 2015-03-27 2016-11-23 上海时代天使医疗器械有限公司 具有储药结构的牙科器械及其制造方法
CN112118886A (zh) * 2018-05-23 2020-12-22 上海汉都医药科技有限公司 活性药物成分的控释系统及其制备方法
CN212973560U (zh) * 2020-09-17 2021-04-16 上海汉都医药科技有限公司 一种口腔滞留装置
CN114191307A (zh) * 2020-09-17 2022-03-18 上海汉都医药科技有限公司 一种口腔滞留装置及其制备方法
WO2022060909A1 (en) * 2020-09-15 2022-03-24 Synagile Corporation Devices and methods for continuous extrusion of a drug into the mouth
CN219764274U (zh) * 2023-04-04 2023-09-29 上海汉都医药科技有限公司 一种口腔给药器

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040158194A1 (en) * 2003-02-06 2004-08-12 Wolff Andy And Beiski Ben Z. Oral devices and methods for controlled drug release
CN105873631A (zh) * 2013-11-05 2016-08-17 辛纳吉勒公司 经由口腔进行连续药物递送的装置和方法
CN106137764A (zh) * 2015-03-27 2016-11-23 上海时代天使医疗器械有限公司 具有储药结构的牙科器械及其制造方法
CN112118886A (zh) * 2018-05-23 2020-12-22 上海汉都医药科技有限公司 活性药物成分的控释系统及其制备方法
WO2022060909A1 (en) * 2020-09-15 2022-03-24 Synagile Corporation Devices and methods for continuous extrusion of a drug into the mouth
CN212973560U (zh) * 2020-09-17 2021-04-16 上海汉都医药科技有限公司 一种口腔滞留装置
CN114191307A (zh) * 2020-09-17 2022-03-18 上海汉都医药科技有限公司 一种口腔滞留装置及其制备方法
CN219764274U (zh) * 2023-04-04 2023-09-29 上海汉都医药科技有限公司 一种口腔给药器

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