JP2016083276A - Intraoral appliance and method for manufacturing intraoral appliance - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an intraoral appliance that can stably fitting a palatal obturator into the oral cavity and to provide a method for manufacturing the intraoral appliance.SOLUTION: The intraoral appliance comprises: a frame made of polycarbonate or the like; and a gel composition formed on the frame and being used by bringing a crosslinked body produced by crosslinking a backbone of poly-N-(carboxymethyl)-N,N-dimethyl-2-(methacryloyloxy)ethanaminium or the like with a crosslinking agent of a methylenebisacrylamide or the like into contact with intraoral mucous.SELECTED DRAWING: None

Description

  The present invention relates to an intraoral device and a method for producing an intraoral device.

  For palate cleft patients, a palatal floor may be attached before cleft palate for the purpose of improving nasopharyngeal closure function. This is because the nasal-oral traffic part of the hard palate is closed with a palate closing floor to prevent exhalation rhinorrhea and prevent language development from being hindered.

  Generally, a ball clasp and an Adams clasp are used as a maintenance device for a resin floor of a palate-closed floor (FIG. 3).

  Attempts have also been made to use denture stabilizers for palate floors, and various denture stabilizers have been proposed.

  In Patent Document 1, a denture stabilizer and denture stabilizer characterized by being a soft adhesive obtained by adding a low-polymerization polyvinyl acetate resin to a deacetic acid type room temperature condensation liquid silicone rubber and stirring and dissolving the denture base, a denture stabilizer is a denture base. A denture is characterized by being backed. Patent Document 2 discloses a denture stabilizer mainly composed of a hydrophobic rubber-like substance (polyisobutylene) and a water-swellable polymer substance. Patent Document 3 discloses a denture stabilizer containing a vinyl acetate resin, petrolatum, ethanol and water.

JP 2008-289833 A JP 2000-351709 A JP 2011-63538 A

  However, when a closed palate floor using a clasp is attached, gingivitis may occur due to the clasp, or lateral growth of the dentition may be hindered. In addition, since the denture stabilizer described in Patent Documents 1-3 is difficult to obtain a uniform thickness, the moving area of the tongue is narrowed by reducing the sense of discomfort during wearing or narrowing the oral cavity space. In some cases, language training was hindered.

  This invention is made | formed in view of the said situation, and aims at providing the intraoral apparatus which can be stably mounted | worn in an intraoral area, and its manufacturing method.

In order to achieve the above object, an intraoral device according to the first aspect of the present invention is provided.
Frame,
A gel composition formed on the frame, the gel composition comprising a crosslinked body having a main chain crosslinked by a crosslinking agent;
With
The gel composition is used in contact with the oral mucosa.

  For example, the main chain may be poly-N- (carboxymethyl) -N, N-dimethyl-2- (methacryloyloxy) ethanaminium, polydimethylacrylamide, polyacrylamide, poly N-ornithine acrylamide, poly N- ( 2-hydroxypropyl) acrylamide, polyhydroxy-ethyl acrylate, polyhydroxyethyl methacrylate, poly (polyethylene glycol) acrylate, poly (polyethylene glycol) methacrylate, poly N-vinyl pyrrolidone, poly N-phenyl acrylamide, polydimethylaminopropyl methacrylamide , Polyacrylic acid, polybenzylmethacrylamide, polyvinyl alcohol, sodium poly-2-methylpropanesulfonate, sodium polystyrenesulfonate, poly-3 (Methacryloylamino) propyl trimethyl ammonium chloride, poly-acryloyloxyethyl trimethyl ammonium chloride, is at least one selected from polymethacrylate Lato trimethyl ammonium chloride and the group consisting of poly-4-vinylpyridine chloride.

  For example, the main chain is poly-N- (carboxymethyl) -N, N-dimethyl-2- (methacryloyloxy) ethanaminium.

  For example, the cross-linking agent is methylene bisacrylamide, methylene bismethacrylamide, butanediol diacrylate, butanediol dimethacrylate, ethylene glycol diacrylate, ethylene glycol dimethacrylate, allyl (meth) acrylate, triallyl cyanurate, diallyl maleate. , Polyallyl ester, tetraallyloxyethane, triallylamine, tetraallylethylenediamine, pentaerythritol triallyl ester, and ethylenebisacrylamide.

  For example, the frame includes polycarbonate.

  For example, the intraoral device is a palatal closed floor.

  In the method for producing an intraoral device according to the second aspect of the present invention, a monomer, a polymerization initiator, and a crosslinking agent are mixed, the monomer is polymerized to form a main chain, and the main chain is cross-linked by the cross-linking agent. Thus, a step of forming a gel composition on the frame is included.

  For example, the main chain may be poly-N- (carboxymethyl) -N, N-dimethyl-2- (methacryloyloxy) ethanaminium, polydimethylacrylamide, polyacrylamide, poly N-ornithine acrylamide, poly N- ( 2-hydroxypropyl) acrylamide, polyhydroxy-ethyl acrylate, polyhydroxyethyl methacrylate, poly (polyethylene glycol) acrylate, poly (polyethylene glycol) methacrylate, poly N-vinyl pyrrolidone, poly N-phenyl acrylamide, polydimethylaminopropyl methacrylamide , Polyacrylic acid, polybenzylmethacrylamide, polyvinyl alcohol, sodium poly-2-methylpropanesulfonate, sodium polystyrenesulfonate, poly-3 (Methacryloylamino) propyl trimethyl ammonium chloride, poly-acryloyloxyethyl trimethyl ammonium chloride, is at least one selected from polymethacrylate Lato trimethyl ammonium chloride and the group consisting of poly-4-vinylpyridine chloride.

  For example, the main chain is poly-N- (carboxymethyl) -N, N-dimethyl-2- (methacryloyloxy) ethanaminium.

  For example, the cross-linking agent is methylene bisacrylamide, methylene bismethacrylamide, butanediol diacrylate, butanediol dimethacrylate, ethylene glycol diacrylate, ethylene glycol dimethacrylate, allyl (meth) acrylate, triallyl cyanurate, diallyl maleate. , Polyallyl ester, tetraallyloxyethane, triallylamine, tetraallylethylenediamine, pentaerythritol triallyl ester, and ethylenebisacrylamide.

  For example, the polymerization initiator may be benzophenone, 2-oxoglutaric acid, sodium peroxodisulfate, potassium and ammonium salts, hydrogen peroxide, tert-butyl peroxide, tert-butyl hydroperoxide, potassium peroxodiphosphate, tert-butylperoxy At least one selected from the group consisting of pivalate, cumyl hydroperoxide, isopropylbenzyl monohydroperoxide and azobisisobutyronitrile.

  For example, the intraoral device is a palatal closed floor.

  ADVANTAGE OF THE INVENTION According to this invention, the intraoral apparatus which can be stably mounted | worn in an intraoral area, and its manufacturing method can be provided.

FIG. 2 schematically shows a palatal closed floor according to the invention. It is a figure which shows the preparation procedures of the palate closure floor by a present Example. (A) is a figure which shows the upper dentition gypsum model which took the patient's upper jaw impression, (b) is a figure which shows the flame | frame shape | molded based on the upper dentition gypsum model of (a), (c) is a figure which shows the silicon dentition model produced based on the maxillary dentition gypsum model of (a), (d) is a figure which shows the state in which the PCDME gel was formed on the flame | frame, (e ) Is a diagram showing a palatal closed floor after trimming. It is a figure which shows the conventional palate closing floor which uses a clasp.

  First, the intraoral apparatus by this invention is demonstrated in detail.

  An intraoral device according to the present invention comprises a frame and a gel composition formed on the frame.

  A flame | frame plays the role which supports the gel composition mentioned later. The material of the frame can be appropriately selected as long as it is suitable for mounting in the oral cavity and has a mechanical strength sufficient to support the gel composition. For example, polycarbonate, ethylene / vinyl acetate are used. In addition to polymerized resin (EVA), plastics, resins, ceramics and the like that are usually used in the dental field can be used. As the material of the frame, for example, polycarbonate (for example, trade name Imprelon) can be suitably used from the viewpoint of versatility and ease of processing.

  The gel composition formed on the frame serves to contact the oral mucosa and fix the oral device to the oral mucosa. The gel composition includes a crosslinked body in which the main chain (polymer) is crosslinked by a crosslinking agent. Referring to FIG. 1, an intraoral device 100 according to the present invention includes a frame 110 and a gel composition 150 formed on the frame 110. The gel composition 150 has a main chain 120 having a cross-linking agent 130. The cross-linked body 140 is cross-linked. The cross-linked body includes a main chain and a cross-linking agent, and means a state in which the main chain is cross-linked by a cross-linking agent. The gel composition contains a crosslinked body, has adhesiveness, and can be adhesively fixed to the oral mucosa.

  Examples of the main chain included in the gel composition include poly-N- (carboxymethyl) -N, N-dimethyl-2- (methacryloyloxy) ethanaminium (PCDME), polydimethylacrylamide, polyacrylamide, and polyN. Ornithine acrylamide, poly N- (2-hydroxypropyl) acrylamide, polyhydroxy-ethyl acrylate, polyhydroxyethyl methacrylate, poly (polyethylene glycol) acrylate, poly (polyethylene glycol) methacrylate, poly N-vinylpyrrolidone, poly N-phenyl Acrylamide, polydimethylaminopropyl methacrylamide, polyacrylic acid, polybenzylmethacrylamide, polyvinyl alcohol, sodium poly-2-methylpropanesulfonate, polystyrene Sodium sulfonate, poly-3- (methacryloylamino) propyltrimethylammonium chloride (MPTC), polyacryloyloxyethyltrimethylammonium chloride (DMAEA-Q), polymethacrylatoethyltrimethylammonium chloride (MATC), poly-4-vinyl Mention may be made of pyridine chloride or mixtures thereof. From the viewpoint of good adhesion to the oral mucosa, poly-N- (carboxymethyl) -N, N-dimethyl-2- (methacryloyloxy) ethanaminium (PCDME) is preferably used as the main chain. It is done.

  Examples of the cross-linking agent used in the gel composition include methylene bisacrylamide, methylene bismethacrylamide, butanediol diacrylate, butanediol dimethacrylate, ethylene glycol diacrylate, ethylene glycol dimethacrylate, allyl (meth) acrylate, triallylcia. Mention may be made of nurate, diallyl maleate, polyallyl ester, tetraallyloxyethane, triallylamine, tetraallylethylenediamine, pentaerythritol triallyl ester, ethylenebisacrylamide, or mixtures thereof.

  In addition, as a material of a gel composition, what can be used repeatedly by preserve | saving using the optimal preservation | save liquid is preferable. In addition to the above-mentioned crosslinked body, the gel composition may be mixed with a thickener, a stabilizer and the like that can be usually contained in an intraoral device.

  In the intraoral device according to the present invention, the gel composition formed on the frame may be shaped to match the shape of the oral mucosa to be contacted; or the oral cavity where both the frame and the gel composition are in contact You may shape | mold according to the shape of a mucous membrane. A method for producing the intraoral device will be described later.

  The intraoral apparatus according to the present invention can be widely applied as a “floor” in the oral cavity, and can be used for, for example, a palatal closed floor, a hots floor, a retainer, a mouth guard, a denture and the like.

  For example, when the intraoral device according to the present invention is used as a palatal closed bed, the gel composition having adhesiveness can be fixed by contacting the oral mucosa, so that it differs from the conventional palatal closed bed (FIG. 3). Does not require a clasp. For this reason, generation | occurrence | production of the gingivitis resulting from a clasp can be reduced and the hindrance of the lateral growth of a dentition can be avoided. In addition, since there is no clasp, it can be comfortably worn without a feeling of tightening, a feeling of pressure, etc., and can be safely performed without damaging the oral cavity when the palatal closure floor is attached or detached. Furthermore, the gel composition can be formed thinly on a thin frame, and the thickness can be made uniform. For this reason, a sense of incongruity at the time of wearing is reduced, a wide oral space can be secured, and the movable region of the tongue is widened, which is effective for language training.

  Next, a method for producing an intraoral device according to the present invention will be described in detail.

  The method for producing an intraoral device according to the present invention comprises mixing a monomer, a polymerization initiator and a cross-linking agent, polymerizing the monomer to form a main chain, and cross-linking the main chain with the cross-linking agent. Forming a step.

  The monomer used in the method for producing an intraoral device according to the present invention can be appropriately selected as long as it can be polymerized to form an adhesive gel. (Carboxymethyl) -N, N-dimethyl-2- (methacryloyloxy) ethanaminium (PCDME), polydimethylacrylamide, polyacrylamide, poly N-ornithine acrylamide, poly N- (2-hydroxypropyl) acrylamide, poly Hydroxy-ethyl acrylate, polyhydroxyethyl methacrylate, poly (polyethylene glycol) acrylate, poly (polyethylene glycol) methacrylate, poly N-vinyl pyrrolidone, poly N-phenyl acrylamide, polydimethylaminopropyl methacrylamide, poly Acrylic acid, polybenzylmethacrylamide, polyvinyl alcohol, sodium poly-2-methylpropanesulfonate, sodium polystyrenesulfonate, poly-3- (methacryloylamino) propyltrimethylammonium chloride (MPTC), polyacryloyloxyethyltrimethylammonium chloride N- (carboxymethyl) -N, N-dimethyl-2- (methacryloyloxy) which is a main chain such as (DMAEA-Q), polymethacrylatoethyltrimethylammonium chloride (MATC), poly-4-vinylpyridine chloride Ethanaminium, dimethylacrylamide, acrylamide, N-ornithine acrylamide, N- (2-hydroxypropyl) acrylamide, hydroxy-ethyl acrylate, hydride Xylethyl methacrylate, (polyethylene glycol) acrylate, (polyethylene glycol) methacrylate, N-vinyl pyrrolidone, N-phenyl acrylamide, dimethylaminopropyl methacrylamide, acrylic acid, benzyl methacrylamide, vinyl alcohol, sodium 2-methylpropane sulfonate, List sodium styrenesulfonate, 3- (methacryloylamino) propyltrimethylammonium chloride (MPTC), acryloyloxyethyltrimethylammonium chloride (DMAEA-Q), methacrylatoethyltrimethylammonium chloride (MATC), 4-vinylpyridine chloride. Can do. A mixture thereof may be used.

  As the polymerization initiator used in the method for producing an intraoral device according to the present invention, any reagent that generates free radicals can be used as appropriate. For example, benzophenone, 2-oxoglutarate, sodium peroxodisulfate, potassium, and ammonium Salt, hydrogen peroxide, tert-butyl peroxide, tert-butyl hydroperoxide, potassium peroxodiphosphate, tert-butyl peroxypivalate, cumyl hydroperoxide, isopropylbenzyl monohydroperoxide, azobisisobutyronitrile, or these Can be mentioned. As for the polymerization initiator, for example, it may be added when the monomer and the crosslinking agent are mixed, or it may be preliminarily applied to the frame, or may be preliminarily included (mixed) in the frame. It may be left.

  Examples of the cross-linking agent and the frame used in the method for producing an intraoral device according to the present invention include those described above.

  In the method for producing an intraoral device according to the present invention, for example, N- (carboxymethyl) -N, N-dimethyl-2- (methacryloyloxy) ethanaminium as a monomer, ethylenebisacrylamide as a cross-linking agent, and polymerization initiator When benzophenone or 2-oxoglutaric acid is used, the polymerization reaction may be advanced by irradiation (for example, about 8 hours) with ultraviolet light (for example, wavelength 365 nm) in an argon atmosphere. In addition, as a method of generating free radicals for initiating polymerization, a method of applying heat as a stimulus under the use of an appropriate polymerization initiator; a method of using a redox reaction; a method of irradiating ultrasonic waves; A method of irradiating microwaves; a method of irradiating gamma rays or the like can be used.

  A specific aspect of the method for producing an intraoral device according to the present invention will be described.

First, a mode in which a frame is formed according to the shape of the oral mucosa and then a gel composition is formed on the frame will be described. In this case, for example, the intraoral device can be produced by the following procedure.
(I) A frame is formed in accordance with the shape of the oral mucosa. As a molding method, for example, there is a method in which a frame is molded by a dental pressure molding machine using a polycarbonate plate on a maxillary dentition model obtained by taking an impression of a patient's upper jaw.
(Ii) A solution containing a monomer and a crosslinking agent is poured into an upper dentition model obtained by taking an impression of the upper jaw of a patient.
(Iii) A frame coated with a polymerization initiator (formed according to the shape of the oral mucosa in (i) above) is covered.
(Iv) Ultraviolet light is irradiated for a certain period of time in an argon atmosphere to form a gel composition on the frame.
(V) After forming the gel composition, the gel composition is removed from the used maxillary dentition model.
(Vi) Rinse with pure water; Trim to the required size, etc., and use it in the oral cavity.

Next, the aspect which forms a gel composition on a flame | frame, and shape | molds according to the shape of an intraoral mucous membrane in the state by which the gel composition was formed on a flame | frame after that is demonstrated. In this case, for example, the intraoral device can be produced by the following procedure.
(I) A solution in which a monomer, a polymerization initiator, and a crosslinking agent are mixed is poured onto the frame.
(Ii) Irradiate ultraviolet light for a certain period of time in an argon atmosphere to form a gel composition on the frame.
(Iii) After forming the gel composition, it is applied to a maxillary dentition model produced by taking an impression of the patient's upper jaw, and shaped according to the shape of the oral mucosa using a dental pressure molder.
(Iv) Wash with pure water; Trim to the required size, etc., and use it in the oral cavity.

  According to the method for producing an intraoral device according to the present invention, an intraoral device such as a palate-closed floor, a hots floor, a retainer, a mouth guard, and a denture can be easily produced. In addition, for example, after taking an impression of a dental model of a patient in the hospital, an intraoral device can be produced in a short time.

  Hereinafter, the present invention will be specifically described with reference to examples. However, the present invention is not limited to these examples.

Example 1
A closed palate bed using poly-N- (carboxymethyl) -N, N-dimethyl-2- (methacryloyloxy) ethanaminium (PCDME) gel was prepared as follows.

(1) Production of frame of palatal closure floor First, an impression of the upper jaw of a patient was obtained, and an upper dentition gypsum model (FIG. 2 (a)) was produced.

  Next, a 1 mm polycarbonate plate (Imperon S, manufactured by Rocky Mountain Co.) is used for the prepared maxillary dentition gypsum model, and the frame (FIG. 2 (b)) is formed by Biostar (manufactured by Rocky Mountain Morita Co., Ltd.). Produced.

(2) Production of a silicon dentition model First, an impression of a maxillary dentition model was obtained with an alginate impression agent.

  Next, a silicon dental impression material (memozil 2, manufactured by Heraeus Kultzer) was added to the above impression to produce a silicon dentition model (FIG. 2 (c)).

(3) Preparation of PCDME gel Ethylenebisacrylamide (EBAM) (crosslinking agent) was added to N- (carboxymethyl) -N, N-dimethyl-2- (methacryloyloxy) ethanaminium (CDME) (monomer) An aqueous solution was prepared. This aqueous solution was poured into the above-mentioned silicon dentition model and covered with a polycarbonate frame (described above) coated with a benzophenone solution (0.3 g of benzophenone and 2 g of polyvinyl acetate dissolved in 100 g of acetone) as a polymerization initiator, The CDME was polymerized by irradiating ultraviolet light having a wavelength of 365 nm for 8 hours under an argon atmosphere. After the polymerization reaction, the polycarbonate frame to which the PCDME gel was adhered was removed from the silicon dentition model and washed with pure water.

(4) Shaping of palate-closed floor The PCDME gel obtained as described above (FIG. 2 (d)) was trimmed to obtain a palate-closed floor (FIG. 2 (e)). It was confirmed that when the finger was pressed against the PCDME gel side of the obtained palatal closed floor and lifted, the palatal closed floor was lifted.

  The PCDME gel used this time has the property that the degree of adhesion changes depending on the degree of wetting, and the property that it absorbs moisture and expands. By placing the frame inside the oral cavity and mounting PCDME gel on the mucosa side, it was considered that the influence of moisture in the oral cavity was reduced, and appropriate wetting and adhesion to the mucosa could be obtained. It was considered that the expansion coefficient can be reduced by reducing the thickness of the PCDME gel.

100 Intraoral device 110 Frame 120 Main chain 130 Crosslinker 140 Crosslinked body 150 Gel composition

Claims (12)

Frame,
A gel composition formed on the frame, the gel composition comprising a crosslinked body having a main chain crosslinked by a crosslinking agent;
With
An intraoral device used by bringing the gel composition into contact with the oral mucosa. The main chain is composed of poly-N- (carboxymethyl) -N, N-dimethyl-2- (methacryloyloxy) ethanaminium, polydimethylacrylamide, polyacrylamide, poly N-ornithine acrylamide, poly N- (2- Hydroxypropyl) acrylamide, polyhydroxy-ethyl acrylate, polyhydroxyethyl methacrylate, poly (polyethylene glycol) acrylate, poly (polyethylene glycol) methacrylate, poly N-vinyl pyrrolidone, poly N-phenyl acrylamide, polydimethylaminopropyl methacrylamide, poly Acrylic acid, polybenzylmethacrylamide, polyvinyl alcohol, sodium poly-2-methylpropanesulfonate, sodium polystyrenesulfonate, poly-3- (meta Riroiruamino) trimethylammonium chloride, poly-acryloyloxyethyl trimethyl ammonium chloride, is at least one selected from polymethacrylate Lato trimethyl ammonium chloride and the group consisting of poly-4-vinylpyridine chloride,
The intraoral device according to claim 1. The main chain is poly-N- (carboxymethyl) -N, N-dimethyl-2- (methacryloyloxy) ethanaminium,
The intraoral device according to claim 1 or 2. The cross-linking agent is methylene bisacrylamide, methylene bismethacrylamide, butanediol diacrylate, butanediol dimethacrylate, ethylene glycol diacrylate, ethylene glycol dimethacrylate, allyl (meth) acrylate, triallyl cyanurate, diallyl maleate, poly At least one selected from the group consisting of allyl ester, tetraallyloxyethane, triallylamine, tetraallylethylenediamine, pentaerythritol triallyl ester and ethylenebisacrylamide,
The intraoral device according to any one of claims 1 to 3. The frame includes polycarbonate;
The intraoral device according to any one of claims 1 to 4, wherein the intraoral device is characterized. A palatal closed floor,
The intraoral device according to any one of claims 1 to 5, wherein   Intraoral including a step of mixing a monomer, a polymerization initiator, and a crosslinking agent, polymerizing the monomer to form a main chain, and crosslinking the main chain with the crosslinking agent to form a gel composition on the frame Device fabrication method. The main chain is composed of poly-N- (carboxymethyl) -N, N-dimethyl-2- (methacryloyloxy) ethanaminium, polydimethylacrylamide, polyacrylamide, poly N-ornithine acrylamide, poly N- (2- Hydroxypropyl) acrylamide, polyhydroxy-ethyl acrylate, polyhydroxyethyl methacrylate, poly (polyethylene glycol) acrylate, poly (polyethylene glycol) methacrylate, poly N-vinyl pyrrolidone, poly N-phenyl acrylamide, polydimethylaminopropyl methacrylamide, poly Acrylic acid, polybenzylmethacrylamide, polyvinyl alcohol, sodium poly-2-methylpropanesulfonate, sodium polystyrenesulfonate, poly-3- (meta Riroiruamino) trimethylammonium chloride, poly-acryloyloxyethyl trimethyl ammonium chloride, is at least one selected from polymethacrylate Lato trimethyl ammonium chloride and the group consisting of poly-4-vinylpyridine chloride,
The manufacturing method of the intraoral apparatus of Claim 7 characterized by the above-mentioned. The main chain is poly-N- (carboxymethyl) -N, N-dimethyl-2- (methacryloyloxy) ethanaminium,
A method for producing an intraoral device according to claim 7 or 8. The cross-linking agent is methylene bisacrylamide, methylene bismethacrylamide, butanediol diacrylate, butanediol dimethacrylate, ethylene glycol diacrylate, ethylene glycol dimethacrylate, allyl (meth) acrylate, triallyl cyanurate, diallyl maleate, poly At least one selected from the group consisting of allyl ester, tetraallyloxyethane, triallylamine, tetraallylethylenediamine, pentaerythritol triallyl ester and ethylenebisacrylamide,
The method for producing an intraoral device according to any one of claims 7 to 9. The polymerization initiator includes benzophenone, 2-oxoglutaric acid, sodium peroxodisulfate, potassium and ammonium salts, hydrogen peroxide, tert-butyl peroxide, tert-butyl hydroperoxide, potassium peroxodiphosphate, tert-butyl peroxypivalate At least one selected from the group consisting of cumyl hydroperoxide, isopropylbenzyl monohydroperoxide and azobisisobutyronitrile;
The method for producing an intraoral device according to any one of claims 7 to 10. The intraoral device is a palatal closed floor;
The method for producing an intraoral device according to any one of claims 7 to 11.