WO2016204026A1 - Nostril indwelling device - Google Patents

Nostril indwelling device Download PDF

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Publication number
WO2016204026A1
WO2016204026A1 PCT/JP2016/066916 JP2016066916W WO2016204026A1 WO 2016204026 A1 WO2016204026 A1 WO 2016204026A1 JP 2016066916 W JP2016066916 W JP 2016066916W WO 2016204026 A1 WO2016204026 A1 WO 2016204026A1
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WO
WIPO (PCT)
Prior art keywords
nasal cavity
insert
nasal
placement device
drug
Prior art date
Application number
PCT/JP2016/066916
Other languages
French (fr)
Japanese (ja)
Inventor
阪根 信一
幹太 倉内
貴史 本田
坂尻 浩一
Original Assignee
seven dreamers laboratories株式会社
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
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Application filed by seven dreamers laboratories株式会社 filed Critical seven dreamers laboratories株式会社
Priority to JP2017525157A priority Critical patent/JPWO2016204026A1/en
Publication of WO2016204026A1 publication Critical patent/WO2016204026A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body

Definitions

  • the present invention relates to a nasal cavity indwelling device.
  • a patch such as an adhesive patch holding the drug in a contact portion with skin or mucous membrane has been known (for example, see Patent Document 1).
  • an object of the present invention is to provide a nasal indwelling device capable of bringing drugs into contact with the mucous membrane for a certain period of time.
  • a nasal indwelling device comprising an insert having a longitudinally proximal end and a distal end, for placing the insert in the nasal cavity,
  • the insert includes a drug holding unit capable of holding drugs, At least a part of the medicine holding part is exposed on the surface between the proximal end and the distal end of the insert, and is configured so that the surface and the mucous membrane of the nasal cavity come into contact with each other at the time of placement. Yes.
  • the insert is inserted from the nostril into the nasal cavity and placed in the nasal cavity.
  • the contact surface of the insert placed in the nasal cavity is in contact with the mucous membrane of the nasal cavity with the drug holding part holding the drug exposed. Therefore, the drugs can be brought into contact with the mucous membrane for a desired time.
  • the nasal cavity placement device further comprises a nasal cavity mounting body for mounting the insert body on the nasal cavity,
  • the nasal cavity mounting body is preferably connected to the proximal end of the insert.
  • the nasal cavity mount body when the nasal cavity placement device is inserted into the nasal cavity from the distal end of the insert body, the nasal cavity mount body is connected to the proximal end of the insert body. Located in. Therefore, the nasal cavity mounting body inside or outside the nostril can be operated with fingers or the like, and the nasal cavity mounting body can be mounted in the state where the insertion body is placed in the nasal cavity on the nostril side. Similarly, the nasal cavity wearing body can be operated with fingers or the like, and the insertion body can be pulled out from the nasal cavity.
  • the insert is preferably a tube having a circular cross section.
  • the insert is a tube having an annular cross section
  • fluid such as air and mucus
  • the fluid flowing in from the nostril side can flow into and out of the pharynx side, and the fluid flowing in from the pharyngeal side can flow into and out of the nostril side through the tube of the insert. Therefore, physiological phenomena such as nasal breathing are not easily inhibited by the nasal cavity placement device.
  • the surface area of the insert is increased, it is possible to hold the drug on the back surface as well as on the back surface of the tube in the drug holding section.
  • an opening is defined between the nasal cavity wearing body and the proximal end of the insertion body.
  • the mucous membrane of the nasal cavity placement device when the insert is placed in the nasal cavity, the mucous membrane of the nasal cavity placement device is exposed from the nostril to the opening toward the nasal cavity wearing body. Inhalation from the nostril side toward the pharynx side comes into contact with the exposed mucous membrane and then flows into the insert through the opening. Therefore, the nasal cavity indwelling device hardly inhibits the physiological action of humidification and warming of inspiration by the mucous membrane.
  • the nasal cavity mounting body includes a support portion that extends toward the insertion body and is connected to a proximal end of the insertion body, It is preferable that the support portion has higher rigidity than the insert.
  • the insertion body when the insertion body is inserted from the nostril toward the nasal cavity, the insertion body can be inserted while the rigid support portion supports the insertion body. Therefore, the insert can be easily inserted into the nasal cavity.
  • the insert is preferably a tube having a U-shaped cross section.
  • the insert when the insert is placed in the nasal cavity, the insert is formed with a portion that opens in the longitudinal direction. Inhalation from the nostril side toward the pharynx side can contact the mucous membrane at the opening. Therefore, the nasal cavity indwelling device hardly inhibits the physiological action of humidification and warming of inspiration by the mucous membrane. In addition, since the back of the tube is exposed at the part that opens in the longitudinal direction, the medicines can be easily held on the back of the tube by spraying or other methods even after it is molded into the tube of the insert. Can be made.
  • the insert includes a thin plate-like part provided with the medicine holding part,
  • the thin plate-like portion preferably has a shorter length than the nasal cavity wearing body.
  • the thin plate-like part having a large length in the short direction extends in the nasal cavity. Therefore, it becomes easy to bring the medicine holding part provided in the thin plate-like part into contact with the mucous membrane at a predetermined position of the nasal cavity.
  • the thin plate portion is preferably elastically deformable.
  • the insert when the insert is inserted from the nostril toward the nasal cavity, the thin plate-like portion of the insert is elastically deformed according to the shape of the nasal cavity. Therefore, the insert can be easily inserted into the nasal cavity.
  • the thin plate-like portion is configured by connecting a plurality of sheet-like members to each other.
  • each of the plurality of sheet-like members when the insert is placed in the nasal cavity, each of the plurality of sheet-like members can contact the mucous membrane at a predetermined position. Therefore, the medicine holding part provided in the thin plate-like part can be brought into contact with the mucous membrane at a plurality of locations.
  • the surface area of the inserted body is larger than that of a thin plate-shaped portion formed of a single sheet-like member, and the area in contact with the mucous membrane can be increased. Furthermore, since a gap is formed between the sheet-like members, physiological phenomena such as nasal breathing are not easily inhibited.
  • a cross section of the thin plate-like portion has a shape that becomes thinner toward a surface side where the medicine holding portion is exposed.
  • the cross section of the thin plate-like part is similar to the shape of the nostril and nasal cavity, and the deformation required for the insert is small. Therefore, the insert can be easily inserted into the nasal cavity. Moreover, since there is a relatively thick part in the shape of the thin plate-like part, a large amount of drugs can be held in that part.
  • the length of the thin plate-like portion in the short direction decreases along the distal end.
  • the thin plate-like portion when the insertion body is started to be inserted from the nostril toward the nasal cavity, the thin plate-like portion has a short length in the short direction on the distal end side of the insertion body where the insertion is started. Therefore, the insertion of the insert can be easily started. Further, on the proximal end side of the insert that comes into contact with the mucous membrane, since the thin plate-like portion has a large length in the short direction, the medicine holding portion provided in the thin plate-like portion is attached to the mucosa in a predetermined position. It becomes easy to make it contact.
  • the nasal cavity mounting body includes a support portion that is connected to a proximal end of the insert and is intubated into the insert. It is preferable that the support portion has higher rigidity than the insert.
  • the insertion body when the insertion body is inserted from the nostril toward the nasal cavity, the insertion body can be inserted while the rigid support portion supports the insertion body. Therefore, the insert can be easily inserted into the nasal cavity.
  • the nasal cavity wearing body includes a pair of sandwiching portions facing each other and an elastically deformable coupling portion that couples the pair of sandwiching portions.
  • the pair of holding parts of the nasal cavity wearing body is placed with the nose column or nose wings sandwiched between fingers or the like.
  • a pair of arranged clamping parts clamp a nasal column or a nasal wing with the elastic force of the connection part which connects them. Therefore, the insertion body can be stably mounted in a state of being placed in the nasal cavity via the nasal cavity mounting body to be connected.
  • the nasal cavity wearing body includes a locking portion having a circular outer periphery, It is preferable that the locking portion is locked to the nasal vestibule when the insert is placed.
  • the locking part of the nasal cavity mounting body is locked in the nasal vestibule. Therefore, it is possible to suppress a sense of incongruity with the nostril without applying a load to the nose column or wing. Further, since the entire nasal cavity wearing body can be placed in the nasal cavity to such an extent that it can be extracted from the nostril, in that case, the nasal cavity placement device is not exposed outside the nasal cavity.
  • the nasal cavity mounting body is preferably a spring-like member having a C-shaped cross section.
  • the nasal cavity mounting body which is a C-shaped spring member
  • the nasal cavity mounting body which is a C-shaped spring member
  • the external force applied to the spring member is released and opened, and the open spring member is locked in the nasal vestibule or nostril. Therefore, it can be locked at any position in the nasal vestibule and nostril.
  • the mucous membrane preferably includes at least a kieselbach region.
  • the contact surface of the insert comes into contact with the kieselbach region.
  • veins are concentrated under the mucous membrane of the region, so that the absorbability of drugs is high. Therefore, the absorbability of the held medicines can be improved.
  • the medicine holding part has a porous structure.
  • the drug holding part having a porous structure absorbs and holds the drug in the porous part. Therefore, a larger amount of drugs can be retained.
  • the medicine holding unit preferably has a matrix structure.
  • the matrix structure has an effect of relaxing the absorption rate of drugs. Therefore, the time for which the drugs are absorbed by the mucous membrane can be extended.
  • the matrix structure is formed as a crosslinked structure by polymerizing monomers and / or polymers. Therefore, by setting the reaction conditions of the polymerization reaction (for example, reaction temperature, monomer and polymer composition, concentration) to a predetermined condition, good reproducibility of the cross-linked structure is obtained, and the absorption rate between the nasal indwelling devices is increased. Variations can be suppressed.
  • the nasal cavity indwelling device is capable of bringing drugs into contact with the mucous membrane for a certain period of time.
  • (A) It is a front view which shows typically an example of the nasal cavity indwelling device which concerns on Embodiment 1 of this invention.
  • (B) It is a left view. It is a figure which shows typically an example of the state by which the C-shaped spring member which concerns on Embodiment 1 of this invention was used for the nose.
  • (A) It is the front view which looked through the nose from the nasal septum side which shows typically an example of the state by which the insert which concerns on Embodiment 1 of this invention was detained in the nasal cavity.
  • (B) It is the figure which saw through the nose from the nasal column side.
  • (C) It is the rear view which saw through the nose from the left cheek side.
  • (A) It is a front view which shows typically the modification of the insertion body which concerns on Embodiment 1 of this invention.
  • (B) It is a left view.
  • (A) It is the front view which looked through the nose from the nasal septum side typically showing the modification of the state where the insert concerning Embodiment 1 of the present invention was detained in the nasal cavity.
  • (B) It is the figure which saw through the nose from the nasal column side.
  • (C) It is the rear view which saw through the nose from the left cheek side.
  • (A) It is a front view which shows typically an example of the nasal cavity indwelling device which concerns on Embodiment 2 of this invention.
  • (B) It is a left view.
  • (A) It is the front view which looked through the nose from the nasal septum side which shows typically an example of the state by which the insert based on Embodiment 2 of this invention was detained in the nasal cavity.
  • (B) It is the figure which saw through the nose from the nasal column side.
  • (C) It is the rear view which saw through the nose from the left cheek side.
  • (A) It is a front view which shows typically the modification 1 of the insertion body which concerns on Embodiment 2 of this invention.
  • (B) It is a left view.
  • (A) It is a front view which shows typically the modification 2 of the insertion body which concerns on Embodiment 2 of this invention.
  • (B) It is a left view.
  • the insert is a tube.
  • FIG. 1A is a front view schematically showing an example of the nasal cavity indwelling device according to the first embodiment.
  • FIG. 1B is a left side view.
  • the nasal cavity placement device 1A includes an insertion body 10A and a nasal cavity mounting body 20A along the longitudinal direction (the X direction in FIG. 1 (A)). Inserted and placed in nasal cavity.
  • the term “indwelling” refers to the retention of drugs, which will be described later, to the extent necessary to absorb the mucous membrane for a predetermined amount and for a predetermined time.
  • the time is appropriately set according to the drug, and is, for example, 5.0 minutes to 30 days, and preferably, for example, 5.0 minutes to 10 minutes when the drug is insulin.
  • the time is preferably 3.0 hours to 6.0 hours.
  • the insert 10A is a cross-sectional annular tube comprising a drug retaining portion 101, a contact surface 102, a proximal end 103, a distal end 104, a proximal end opening 105, and a distal end opening 106. is there.
  • the length in the longitudinal direction (X direction in FIG. 1 (A)) of the nasal cavity placement device 1A is the length
  • the dimension in the short direction is the width
  • the dimension in the direction perpendicular to the longitudinal direction and the single-handed direction (the Y direction in FIGS. 1A and 1B) is defined as the width.
  • the length of the insert 10A is preferably, for example, 10 mm to 80 mm, and more preferably 30 mm to 80 mm, and even more preferably 50 mm to 80 mm when increasing the amount of drugs to be held.
  • the insertion body 10A may be less than this in accordance with the amount of drugs to be held.
  • the thickness and width of the insert 10A are preferably 8.0 mm to 40 mm.
  • the thickness of the tube is preferably, for example, 0.1 mm to 5.0 mm.
  • the material of the insertion body 10A is not particularly limited as long as it can be placed in the nasal cavity, and examples thereof include resins such as silicone and thermoplastic resin. High-pressure steam sterilization, ethylene oxide gas, ⁇ -ray sterilization, etc. To avoid deterioration of the material, silicone is preferred.
  • the drug holding unit 101 is configured to hold drugs.
  • the medicine holding unit 101 may be configured to hold the medicine by encapsulating the medicine in the layer of the insert 10A. More specifically, the medicine holding unit 101 may have a porous structure or a matrix structure.
  • the method having a porous structure is not particularly limited, and examples thereof include a method of forming the insert 10A itself as a porous body, and a method of bonding the porous body to the outer surface of the tube to form an insert.
  • the porous structure is not particularly limited as long as it has a porous part capable of holding drugs, but the average pore size is preferably 3.0 nm to 300 ⁇ m. In order to hold hydrophobic molecules, 6.0 nm More preferably, it is ⁇ 10.0 nm. Further, in the case of a configuration having a porous structure, the flexibility of the insert 10A is increased and insertion is facilitated.
  • the medicine holding unit 101 may have a matrix structure to hold a medicine.
  • the absorption rate of the drugs in the nasal mucosa is reduced, and the drugs are continuously released for a longer time.
  • a method having a matrix structure is not particularly limited. For example, a method of forming the insert itself as a matrix structure by a sol-gel method, and a method of coating the matrix structure by applying a polymer to the surface of the insert and causing a crosslinking reaction, etc. The method of doing is mentioned. In these methods, drugs are dispersed in a matrix structure.
  • a matrix structure when a matrix structure is formed on the surface of the insert, its thickness is preferably 5.0 fm to 0.1 mm so as not to impair the flexibility of the insertion part and the medicine holding part.
  • the substance that forms the matrix structure is as flexible as or more than the drug holding part, such as gel or gel, the maximum may be 1.0 mm.
  • the material constituting the matrix structure is preferably a biostable polymer or a bioabsorbable polymer.
  • the matrix structure refers to a structure in which the polymer is intertwined in a complicated manner such as by crosslinking, and includes a matrix structure used for a known sustained-release system for drugs.
  • the bioabsorbable polymer is not particularly limited as long as at least a part of the polymer can be absorbed by the living body.
  • polycaprolactone poly (lactide-co-glycolide), poly (hydroxybutyrate), poly ( Hydroxybutyrate-co-valerate), polydioxanone, polyorthoester, polyanhydride, polyglycolic acid, poly (D, L) lactic acid, poly (glycolic acid-co-trimethylene carbonate), polyphosphoester, polyphospho Ester urethane, polyamino acid, cyanoacrylate, poly (trimethylene carbonate), poly (iminocarbonate), copoly (ether-ester), polyalkylene oxalate, polyphosphazene; fibrin, fibrinogen, cellulose, cellulose Loin, starch, collagen, and hyaluronic acid.
  • the biostable polymer is not particularly limited as long as it is a polymer that is stable to the living body, and examples thereof include polyurethane, silicone, and polyester.
  • Drugs held in the drug holding unit 101 are not limited to the following, but include, for example, pharmaceuticals, quasi drugs; dietary supplements such as various nucleic acids, various vitamins, and iron preparations. Among these, from the viewpoint of ease of holding the drug holding unit 101, liquid drugs are preferable.
  • the medicines widely include things that are intended to affect the structure or function of the human body.
  • the contact surface 102 is a portion where the drug holding portion 101 is exposed between the proximal end 103 and the distal end 104 of the insert 10A.
  • the contact surface 102 is formed on the entire surface of the insert 10A. Has been. At least a part of the contact surface 102 comes into contact with the mucous membrane of the nasal cavity b during placement.
  • the insertion body 10A is held at the proximal end 103 by the nasal cavity mounting body 20A at the time of indwelling, but the distal end 104 becomes a free end, so that the insertion body 10A is deformed according to gravity and the shape of the insertion body 10A.
  • the surface on the proximal end 103 side of this is in contact with the adjacent mucosa. If the medicine holding part 101 is exposed as the contact surface 102 on the surface of the insert 10A, the contact surface 102 comes into contact with the adjacent mucosa.
  • the proximal end 103 and the distal end 104 are both ends in the longitudinal direction of the insert 10A.
  • the proximal end 103 is disposed on the nostril (FIG. 3 (A) h) side.
  • the distal end 104 is arranged on the pharynx (FIG. 3 (A) i) side.
  • the insert 10A is a tube having a circular cross section, and has a proximal end opening 105 on the proximal end 103 side and a distal end opening 106 on the distal end 104 side.
  • the section being circular may be circular or substantially circular in cross section. If the cross section is circular or substantially circular, there is a tendency that the insert can be more smoothly inserted into the nasal cavity due to the small friction generated when the insert is inserted into the nasal cavity.
  • the nasal cavity mounting body 20A is provided in the nasal cavity placement device 1A in order to mount the insert 10A on the nasal cavity b.
  • the nasal cavity mounting body 20 ⁇ / b> A includes a spring-like member 201 having a C-shaped cross section and a support body 202. Since the spring-like member 201 is locked at the position of the nasal vestibule when the insertion body 10A is indwelled, the spring-like member 201 is locked without applying a load to the site outside the nasal cavity b.
  • FIG. 2 is a diagram schematically illustrating an example of a state in which the spring member 201 according to the first embodiment is used for the nose.
  • the spring-like member 201 is an elastic body having a C-shaped cross section.
  • the spring member 201 locks the insert 10A in the nasal cavity by pressing the nasal wing k and the nasal column j from the inside.
  • the spring-like member 201 is made of spring steel, for example.
  • the support portion 202 extends in the longitudinal direction toward the insert 10A and is connected to the proximal end 103 of the insert 10A. This support portion 202 has higher rigidity than the insert 10A.
  • the material of the support portion 202 can be selected as appropriate as long as it has higher rigidity than the insert 10A.
  • An example is polypropylene.
  • the shape of the support portion 202 is not particularly limited, but is preferably a shape that increases rigidity, for example, a solid bar shape.
  • the support portion 202 has a length of, for example, 1.0 mm to 15 mm.
  • the length of the support 202 is 15 mm or more in order to prevent the insert 10A and the support 202 from peeling off and dropping off.
  • the cross section is substantially circular, the outer diameter is, for example, 8.0 mm to 20 mm. Note that when the support portion 202 is intubated and used in the insertion body 10A, the length is increased by the amount of intubation. (how to use)
  • FIG. 3 (A) is a front view seen through the nose from the nasal septum side, schematically showing an example of a state in which the insert 10A according to Embodiment 1 is placed in the nasal cavity b.
  • FIG. 3B is a perspective view of the nose from the nasal column side.
  • FIG. 3C is a rear view seen through the nose from the left cheek side.
  • each part of the nose includes the paranasal sinus a, the nasal cavity b, the kieselbach c, the middle turbinate d, the lower nasal turbinate e, the lower nasal passage f, the upper lip g, the nostril h, and the pharynx.
  • i, nasal column j, nose wing k, and nose tip l are shown.
  • the distal end 104 side of the insert 10A is picked up and applied to the nostril h.
  • the nasal cavity mounting body 20A is picked up and the insertion body 10A is inserted into the nasal cavity b.
  • the insertion is performed while grasping the nasal cavity mounting body 20A of the nasal cavity placement device 1A.
  • an external force acts on the insertion body 10A through the proximal end 103 to which the support portion 202 of the nasal cavity mounting body 20A is connected, and the insertion body 10A is inserted into the nasal cavity b.
  • the support portion 202 is larger in rigidity than the insertion body 10A, the support portion 202 is not bent at the time of insertion, and an external force can be efficiently transmitted to the insertion body 10A.
  • the spring-like member 201 When inserting the insertion body 10A into the nasal cavity b, the spring-like member 201 is inserted from the nostril h while the spring-like member 201 is closed by the external force of the fingers. If it does so, fingers will remove
  • the opened spring-like member 201 opens and stops in the nasal vestibule or nostril h, and locks the insert 10A. Thereafter, when the nasal cavity indwelling device 1A is pulled out after being left for a predetermined time, the spring-like member 201 can be directly grasped and pulled out.
  • the insertion body 10A is inserted into the nasal cavity b from the nostril h and placed in the nasal cavity b.
  • the nasal cavity placement device 1A does not reach the pharynx i.
  • the contact surface 102 is in contact with the mucous membrane of the kieselbach site c.
  • the Kieselbach region c has a concentration of veins under the mucous membrane of the region, and therefore, the absorption rate of the drugs tends to be higher than that of the mucous membrane of the nasal cavity b. As preferred.
  • the insert 10A is an annular tube, even when the insert 10A is placed in the nasal cavity, the proximal end opening 105, the distal end opening 106, In between, fluids such as air and mucus flow into and out of the insertion body 10A, and physiological actions such as nasal breathing are unlikely to be hindered.
  • the proximal end opening 105 is disposed in the kieselbach part c, and fluid such as air and mucous membrane flows from the opening 105 into the insert 10A.
  • fluid such as air and mucous membrane flows from the opening 105 into the insert 10A.
  • the inspiration from the nostril h to the pharynx i comes into contact with the exposed mucous membrane and is heated and humidified.
  • the mucous membrane and the drug holding part can be brought into contact with each other for a long time, a specific effect is exhibited when a specific drug is used.
  • a specific drug for example, when a water-soluble drug having low gastrointestinal absorbability is used as a drug, even if it is low absorbable, absorption can be maintained for a long period of time, so that a sufficient therapeutic effect can be desired.
  • the absorption rate is fast and metabolized quickly in the body, but if it is harmful to the human body at high concentrations, once the nasal indwelling device of this embodiment is used, the drugs are gradually released in small amounts, Its medicinal properties can be maintained safely.
  • FIG. 4A is a front view schematically showing a modification of the insert according to the first embodiment.
  • FIG. 4B is a left side view.
  • FIG. 5 (A) is a front view seen through the nose from the nasal septum side, schematically showing a modification of the state in which the insert according to Embodiment 1 is placed in the nasal cavity.
  • FIG. 5B is a perspective view of the nose from the nasal column side.
  • FIG. 5C is a rear view of the nose seen through from the left cheek side.
  • the insert having a tube with an annular cross section has been described.
  • the present invention is not limited to this, and for example, as shown in FIG. 4B, the insert 10B having a U-shaped cross section. It may be.
  • the U-shape does not need to be strictly U-shaped, and includes, for example, V-shape and C-shape.
  • the insert 10B is a tube having a U-shaped cross section, when the insert 10B is placed in the nasal cavity, an opening is formed in the insert 10B along the longitudinal direction. Since there is an opening, the physiological action of humidification and warming of inhalation by the mucous membrane during placement is more difficult to be inhibited. Moreover, since the back surface of the tube of the insertion body 10B can be easily exposed by opening the opening, it is easy to apply drugs to the back surface.
  • the spring-like member 201a is disposed at a predetermined angle with respect to the insert 10B. Thereby, it can be adapted to the shape of the nasal cavity, and the uncomfortable feeling at the time of placement can be alleviated.
  • the support 202a is intubated into the insert 10B.
  • the rigidity of the insertion body 10B is increased, and bending of the insertion body 10B during insertion into the nasal cavity can be suppressed.
  • the cross-sectional shape of the insert is not limited to the described annular and U-shape.
  • the shape obtained by deforming the annular shape may be, for example, a triangle, a quadrangle, a pentagonal polygon; a shape having a concave shape or a convex shape.
  • the insert is not particularly limited as long as it is a tube, and may be a tube having a slit in the longitudinal direction.
  • a method of forming a slit in the tube for example, a method of cutting out a part of the tube after manufacturing the tube, forming the sheet by winding the sheet, without bonding the ends of the sheet to each other in the wound direction There is a method in which a slit is provided between them.
  • the length of the insert does not reach the pharynx i in order to reduce the uncomfortable feeling at the time of placement. If there is, the length of the insert may reach the pharynx i.
  • a method for enabling the drug holding unit 101 to hold the drug is not particularly limited.
  • a method of applying drugs to the surface of the tube by spraying a method of forming the tube as a porous body, a method of holding the drug of fluid in the tube, a tube made of a material having a certain permeability, and a tube
  • a method of including the drug inside the tube and a method of forming the tube itself from the material of the drug In the method of applying a drug to the surface of the tube, a larger amount of the drug can be held by holding the drug not only on the surface of the tube but also on the back and inside.
  • the present invention is not limited to this.
  • at least a part of the drug from the contact surface 102 is gradually discharged from the drug holding part 101 due to warming at body temperature or mucus secreted from the mucous membrane, and flows to the pharynx i to be administered to the digestive tract. May be.
  • the example in which all of the medicine holding unit 101 is exposed as the contact surface 102 of the insert 10A on the entire surface of the insert 10A has been described, but is not limited thereto.
  • a part of the medicine holding unit 101 may be exposed as a contact surface 102 on a part of the insertion body 10A.
  • the medicine holding part 101 is included in the insertion body 10 ⁇ / b> A, and a part of the medicine holding part 101 is exposed as the contact surface 102. Since the entire medicine holding unit 101 is not exposed, the speed at which the medicine is absorbed by the mucous membrane can be reduced.
  • the insert includes a thin plate portion, and the shape of the insert is different from that of the first embodiment.
  • symbol and / or name which are the same as what was used in this Embodiment 1 are attached
  • FIG. 6A is a front view schematically showing an example of the nasal cavity indwelling device according to the second embodiment.
  • FIG. 6B is a left side view thereof.
  • FIG. 7A is a front view seen through the nose from the nasal septum side, schematically showing an example of a state in which the insert according to Embodiment 2 is placed in the nasal cavity.
  • FIG. 7B is a view seen through the nose from the nasal column side.
  • FIG. 7C is a rear view seen through the nose from the left cheek side.
  • the nasal cavity indwelling device 2A includes an insert 11A and a nasal cavity mounting body 20B.
  • the insert 11A includes a thin plate-like portion 110 provided with a medicine holding portion 101, and a proximal end 103 and a distal end 104 in the longitudinal direction.
  • the thin plate-like portion is longer in the short direction than the nasal cavity mounting body 20B. Therefore, in a state where the insert 11A is placed in the nasal cavity (see FIGS. 7A to 7C), the thin plate-like portion 110 of the insert 11A extends widely in the nasal cavity b and is provided in the thin plate-like portion 110.
  • the medicinal product holding part 101 can be brought into contact with the mucous membrane in the nasal cavity b in a larger area.
  • the thin plate portion 110 is a material that can be elastically deformed.
  • the term “elastically deformable” means that the insert 11A is elastic enough to allow the required deformation while it is inserted from the nostril h to the nasal cavity b.
  • the elastically deformable material is, for example, one in which the thin plate portion 110 is formed of a material such as rubber containing silicone. Since the thin plate-like portion 110 can be elastically deformed, when the insert 11A is inserted into the nasal cavity b, it is inserted while being elastically deformed in accordance with the shape of the nasal cavity b, so that the insertion is easy.
  • the width of the thin plate-like portion 110 gradually increases from the proximal end 103 along the approximate center in the longitudinal direction of the insert 11A, and gradually decreases along the distal end 104 from the approximately longitudinal center.
  • the maximum width of the thin plate-like portion 110 is not particularly limited as long as the surface can contact the mucous membrane when placed in the nasal cavity.
  • the length is preferably from 10 mm to 80 mm, more preferably from 10 mm to 40 mm, and even more preferably from 10 mm to 20 mm from the viewpoint of reducing the uncomfortable feeling during placement.
  • the width of the thin plate portion 110 on the proximal end 103 side is preferably 8.0 mm to 30 mm.
  • the width of the thin plate portion 110 on the distal end 104 side is preferably 2.0 mm to 8.0 mm.
  • the thickness is preferably 0.1 mm to 5.0 mm.
  • the nasal cavity mounting body 20B includes a spring-like member 201a and a support portion 202a.
  • the support portion 202a is connected to the proximal end 103 of the insert 11A and is inserted into the insert 11A.
  • the support portion 202a has higher rigidity than the insertion body 11A. Since the insertion body 11A including the thin plate-like portion 110 tends to have a large deformation amount when inserted, the support portion 202a is intubated into the insertion body 11A.
  • FIG. 8A is a front view schematically showing Modification Example 1 of the insert according to Embodiment 2.
  • FIG. FIG. 8B is a left side view.
  • the present invention is not limited to this, and a configuration like the insert body 11B shown in FIG. May be. That is, the thin plate-like portion 110 may be configured by connecting the two sheet-like members 110a to each other in the thickness direction and connecting them with the connecting portion 110b. It should be noted that the number of sheet-like members to be connected is not limited to two and may be larger.
  • the medicine holding part 101 can be brought into contact with the mucous membrane at more places.
  • the surface area of the whole thin plate-shaped part 110 increases, the area of the chemical
  • the sheet-like member 110a has the same shape and size as the thin plate-like portion 110 of the insert 11A. However, the thickness of the sheet-like member 110a is preferably 0.1 mm to 5.0 mm in the whole connected thin plate-like portions.
  • FIG. 9 (A) is a front view schematically showing Modification Example 2 of the insert according to Embodiment 2.
  • FIG. FIG. 9B is a left side view.
  • an insert can hold a drug like an insert 11C illustrated in FIG.
  • You may provide the thin plate-shaped part which has a cross section which is a shape which becomes thin toward the surface 102 side which the part 101 exposes.
  • the cross section of the thin plate-like portion 110 has a triangular shape similar to the shape of the nostril h and the nasal cavity b, and is required for the insert 11C. Deformation is small. Therefore, the insert 11C can be easily inserted into the nasal cavity. Moreover, since there exists a part (thick) where the width
  • the structure (the porous structure, the matrix structure, etc.) in which the drug holding unit holds the drug in the layer of the insert has been described.
  • the method for holding the drug is limited to this. Absent.
  • the medicine holding unit may hold the medicine on the surface of the insert. In this case, since it is not necessary to provide the porous structure or matrix structure as described above in the insertion body, the structure of the medicine holding part can be simplified.
  • the liquid medicine is directly applied to the surface of the insert, and the medicine is held on the surface of the insert by the surface tension acting on the interface between the liquid medicine and the surface of the insert.
  • the liquid medicine is directly applied to the outer surface of the insert, or the insert is made of a material that can penetrate the medicine from the inner surface toward the outer surface.
  • a method of directly applying a liquid drug to the inner surface of the insert may be mentioned.
  • the liquid drug is not particularly limited, but a drug containing a thickener or a gelling agent is preferable from the viewpoint of obtaining higher surface tension.
  • the “thickening agent” means a raw material in which a liquid drug is viscous by being contained in the drug.
  • the “gelling agent” means a raw material that can be solidified or semi-solidified by being contained in the drug.
  • the drugs may contain a thickener and a gelling agent in combination, or each may be contained alone.
  • Specific examples of the thickener include cellulose derivatives such as hydroxypropylcellulose, hydroxypropylmethylcellulose and carboxymethylcellulose; modified starch, xanthan gum, guar gum and tamarind gum.
  • Specific examples of the gelling agent include agar and carrageenan.
  • the liquid drug may further contain a solvent and a dispersant from the viewpoint of adjusting the viscosity of the drug and improving the dispersibility of the drug.
  • the solvent is not particularly limited as long as it dissolves an active ingredient in pharmaceuticals.
  • water monohydric alcohols such as ethanol, diols such as propylene glycol (dihydric alcohols), triols such as glycerin (3 (Hydric alcohol).
  • the dispersant is not particularly limited as long as it disperses the active ingredient in the drug.
  • water a monohydric alcohol such as ethanol, a diol (dihydric alcohol) such as propylene glycol, glycerin, and the like.
  • examples include triol (trihydric alcohol) and water-soluble polymer.
  • the solvent or dispersant contained in the drug can be removed from the drug by means such as heating or vacuum drying after the drug is held on the surface of the insert. For this reason, by further containing a solvent or a dispersant in the drug, liquid components such as the solvent and the dispersant can be removed on the surface of the insert, and the drug in a thinned state can be obtained.
  • the thinned drugs are compared with the case where the drugs are inserted and the liquid drugs are held on the surface of the insert as it is due to the adhesive force acting on the interface between the drugs and the surface of the insert.
  • the drugs can be held on the surface of the insert more stably.
  • the drug holding unit holds the drug on the surface of the insert.
  • a thinned drug film preparation
  • a liquid drug is preliminarily removed from the insert itself or an intermediate medium other than the insert by heating or vacuum drying to form a film preparation, which is then inserted via an adhesive or adhesive.
  • a method of holding the drugs by laminating the film preparation on the surface of the body is mentioned.
  • the size and thickness of the film preparation are not particularly limited as long as they are appropriately set according to the amount and quality of the active ingredient of the drug and the additive contained and can be held in the insert.
  • the adhesive and the pressure-sensitive adhesive are not particularly limited as long as they are not invasive to the human body and the film preparation can be held in the insert, and known materials can be used.
  • a desired position of the insert can be used as a medicine holding part, and the medicine can be easily administered to a desired position in the nasal cavity.
  • the adhesive is not particularly limited as long as it can bond the objects, but for example, a solution containing cellulose derivatives such as hydroxypropylcellulose, hydroxypropylmethylcellulose, carboxymethylcellulose, polyvinylpyrrolidone, polyvinyl alcohol, etc .; wheat And paste made from starch derived from tapioca. Moreover, as an adhesive, you may use what can peel off the target stuck together later. By using such an adhesive, the film preparation can be held once on the surface of the insert, and then the film preparation can be held again at a position on a different surface of the insert. It becomes easier to administer the drugs to a desired position.
  • the liquid medicine holding part holds the medicine on the surface of the insert. It may be achieved by spraying on the surface. Further, in order to more strongly hold the drugs on the surface of the insert, the above-described adhesive or pressure-sensitive adhesive may be provided in advance on the surface of the insert, and the spray agent may be sprayed on the surface. By providing the drugs on the surface of the insert by spraying the spray, the drugs can be easily held.
  • the drugs may be those in which the above-mentioned pressure-sensitive adhesive or adhesive contains a drug component.
  • the drugs By applying such drugs to the surface of the insert as the above liquid drugs or film preparations, the drugs can be held with better adhesion on the surface of the insert.
  • the drug holding unit a configuration in which a plurality of different types of drugs are stacked may be used, or a structure in which the drugs have a concentration gradient in the thickness direction may be used.
  • the first film preparation contains a high concentration of the active ingredient
  • the second film preparation contains the low active ingredient.
  • a concentration gradient of drugs may be provided in the thickness direction of the insert, which is included in the concentration.
  • the drug holding unit increases the affinity with the liquid drug or film preparation held in the drug holding unit.
  • Surface treatment may be applied to the outer surface or inner surface of the insert so as to facilitate the process.
  • the surface treatment examples include a treatment in which the insert is immersed in an aqueous solution of a known acid or base, a treatment in which the insert is left in an ozone atmosphere, and a treatment in which a silane coupling agent and a polymer are reacted with the material on the insert surface.
  • the surface of the insert made of silicone is high in affinity with water-soluble drugs and low in affinity with fat-soluble drugs because the silicone end has a hydroxyl group. . Therefore, the surface of the insert becomes fat-soluble by reacting the insert made of silicone with the silane coupling agent and a polymer reactive with the silane coupling agent on the surface of the insert.
  • the affinity with fat-soluble drugs can be increased, and the fat-soluble drugs can be more strongly retained.
  • the nasal cavity indwelling device including one insert has been described.
  • the present invention is not limited to this, and a nasal cavity indwelling device including two inserts may be used. Two inserts are respectively inserted into the two nostrils.
  • the size of both the length, thickness, etc. For example, one insert may have the same length as the above-described insert, and the other insert may be relatively short. Both may have the same size.
  • each of the two inserts may be provided with a medicine holding part, or only one of them may be provided.
  • one of the inserts may include a drug holding unit that holds a fat-soluble drug, and the other insert may include a drug holding unit that holds a water-soluble drug. In this case, different types of drugs can be held simultaneously.
  • FIG. 10 is a front view schematically showing an example of a state in which the locking part of the nasal cavity mounting body according to the embodiment is locked to the nasal vestibule.
  • FIG. 11 is a front view schematically showing a modification of the nasal cavity wearing body according to the embodiment.
  • FIG. 12 is a front view schematically showing a modification of the nasal cavity mounting body according to the embodiment of the present invention.
  • a nasal cavity mounting body that is a spring member having a C-shaped cross section has been described.
  • the present invention is not limited to this, and has a circular outer periphery as shown in FIGS.
  • a nasal cavity mounting body that includes the locking portions 203a, 203b, and 203c and that is locked to the nasal vestibule when the insertion body is placed may be used.
  • the nasal cavity mounting body 20C includes a locking portion 203a that is a portion having the largest outer diameter, and a spring 204 that is elastically deformed in the insertion direction.
  • the nasal cavity mounting body 20C is connected to the insertion body 10A.
  • the nasal cavity mounting body 20C preferably has a substantially cylindrical shape that is hollow toward the X direction. This allows the fluid to flow into and out of the pharynx from the nostril h together with the insertion body 10A.
  • the nasal cavity mounting body 20C is provided with a locking portion 203a on the end side connected to the insertion body 10A, and the outer diameter decreases toward the other end side not connected to the insertion body 10A.
  • the spring 204 has an effect of reducing external force in the insertion direction, and can be adjusted so that the nasal cavity mounting body 20C is not inserted too much.
  • the nasal cavity mounting body 20D is configured in the same manner as the nasal cavity mounting body 20C shown in FIG. 10 except that it includes a plurality of protrusion-like locking portions 203b. Since the locking force on the nasal vestibule is increased by the plurality of locking portions 203b, the nasal cavity placement device can be more stably attached.
  • the nasal cavity mounting body 20E is connected to the insertion body 10A and has a cone part 205 having a plurality of openings 205a, and is connected to the cone part 205 to constitute the end of the nasal cavity mounting body 20E.
  • Engaging portion 203c The cross-sectional diameter of the cone portion 205 gradually increases from the connecting end of the insert 10A toward the locking portion 203c, and is connected to the locking portion 203c having the maximum cross-sectional diameter.
  • the opening 205a communicates with the inside of the tube of the insert 10A, and allows fluid to flow into and out of the pharynx from the nostril h.
  • the nasal cavity mounting body may be configured to include a pair of sandwiching portions 206 facing each other and an elastically deformable 207 connecting the pair of sandwiching portions 206 as shown in FIG.
  • the nasal cavity mounting body 20F the one connected to the insertion body 10A of the pair of holding portions 206 is inserted from one nostril h, and the other holding portion 206 is inserted into the other nostril h. Since any of the clamping portions 206 are connected to the connecting portion 207, all of them are not inserted into the nostril h. In this case, the pair of holding portions 206 are connected by the connecting portion 207 with the nose column j interposed therebetween.
  • the nasal cavity indwelling device does not go too far into the nasal cavity b and cannot be pulled out.
  • the other holding part 206 may be arranged outside the nose wing k, and the pair of holding parts 206 may be connected by the connecting part 207 with the nose wing k interposed therebetween.
  • clamping part 207 ... connecting part a ... sinuses, b ... nasal cavity, c ... kieselbach region, d ... middle turbinate, e ... bottom Nasal concha, f ... lower nasal passage, g ... upper lip, h ... nostril, i ... pharynx, j ... nasal column, k ... nasal wing, l ... nasal tip

Abstract

The present invention provides a nostril indwelling device 1A which is provided with an insert 10A that has both a proximal end 103 and a distal end 104 in the length direction, and which can allow the insert 10A to dwell in nasal cavity. In the device, the insert 10A is provided with a drug-retaining section 101 which can retain a drug, and at least a part of the drug-retaining section 101 is so configured as to be exposed at a contact surface 102 lying between the proximal end 103 and the distal end 104 of the insert 10A and is also so configured that the contact surface 102 and the mucosa of nasal cavity can contact with each other during the dwelling of the device.

Description

鼻腔留置デバイスNasal indwelling device
 本発明は、鼻腔留置デバイスに関する。 The present invention relates to a nasal cavity indwelling device.
 従前から、薬剤等を非経口投与するためのデバイスとして、皮膚又は粘膜との接触部に薬剤を保持した粘着パッチ等の貼付剤が知られている(例えば、特許文献1参照)。 Conventionally, as a device for administering a drug or the like parenterally, a patch such as an adhesive patch holding the drug in a contact portion with skin or mucous membrane has been known (for example, see Patent Document 1).
特開2009-051840号公報JP 2009-051840 A
 しかしながら、この貼付剤では、その貼付剤を粘膜に用いた場合に、粘膜から分泌される粘液により貼付剤の粘着力を保つことが難しく、短時間で容易に脱落してしまう。また、鼻腔等の身体の表面に露出されていない粘膜に対しては、貼付剤を用いることも、回収することも難しい。 However, with this patch, when the patch is used on the mucous membrane, it is difficult to maintain the adhesive strength of the patch due to mucus secreted from the mucous membrane, and it easily falls off in a short time. In addition, it is difficult to use a patch or to recover the mucous membrane that is not exposed on the surface of the body such as the nasal cavity.
 そこで、本発明は、薬剤類を一定時間粘膜に接触させることが可能な鼻腔留置デバイスを提供することを目的とする。 Therefore, an object of the present invention is to provide a nasal indwelling device capable of bringing drugs into contact with the mucous membrane for a certain period of time.
 長手方向に近位端と遠位端とを有する挿入体を備え、該挿入体を鼻腔に留置させるための鼻腔留置デバイスであって、
 前記挿入体は、薬剤類を保持可能な薬剤類保持部を備え、
 前記薬剤類保持部の少なくとも一部は、前記挿入体の近位端と遠位端との間の表面に露出しており、留置時に前記表面と鼻腔の粘膜とが接触するように構成されている。
A nasal indwelling device comprising an insert having a longitudinally proximal end and a distal end, for placing the insert in the nasal cavity,
The insert includes a drug holding unit capable of holding drugs,
At least a part of the medicine holding part is exposed on the surface between the proximal end and the distal end of the insert, and is configured so that the surface and the mucous membrane of the nasal cavity come into contact with each other at the time of placement. Yes.
 上記構成によれば、挿入体が鼻孔から鼻腔に挿入され、鼻腔に留置される。そして、鼻腔に留置された挿入体の接触表面は、薬剤類を保持した薬剤類保持部を露出した状態で、鼻腔の粘膜と接触している。そのため、薬剤類を所望の時間粘膜に接触させることができる。 According to the above configuration, the insert is inserted from the nostril into the nasal cavity and placed in the nasal cavity. The contact surface of the insert placed in the nasal cavity is in contact with the mucous membrane of the nasal cavity with the drug holding part holding the drug exposed. Therefore, the drugs can be brought into contact with the mucous membrane for a desired time.
 前記鼻腔留置デバイスにおいて、前記挿入体を鼻腔に装着させるための鼻腔装着体をさらに有し、
 前記鼻腔装着体は、前記挿入体の近位端に連結されていることが好ましい。
In the nasal cavity placement device, the nasal cavity placement device further comprises a nasal cavity mounting body for mounting the insert body on the nasal cavity,
The nasal cavity mounting body is preferably connected to the proximal end of the insert.
 上記構成によれば、鼻腔留置デバイスを挿入体の遠位端から鼻腔へ挿入したとき、鼻腔装着体は挿入体の近位端に連結されているため、鼻腔装着体は挿入体よりも鼻孔側に位置する。そのため、鼻孔の内側又は外側にある鼻腔装着体を手指等で操作し、鼻腔装着体を鼻孔側で挿入体を鼻腔に留置された状態で装着させることができる。また、同様に鼻腔装着体を手指等で操作し、挿入体を鼻腔から引き抜くことができる。 According to the above configuration, when the nasal cavity placement device is inserted into the nasal cavity from the distal end of the insert body, the nasal cavity mount body is connected to the proximal end of the insert body. Located in. Therefore, the nasal cavity mounting body inside or outside the nostril can be operated with fingers or the like, and the nasal cavity mounting body can be mounted in the state where the insertion body is placed in the nasal cavity on the nostril side. Similarly, the nasal cavity wearing body can be operated with fingers or the like, and the insertion body can be pulled out from the nasal cavity.
 前記鼻腔留置デバイスにおいて、前記挿入体は、断面が環状のチューブであることが好ましい。 In the nasal cavity placement device, the insert is preferably a tube having a circular cross section.
 上記構成によれば、挿入体は断面が環状のチューブであるため、挿入体が鼻腔に留置されたとき、挿入体内部に空気、粘液等の流体が流出入可能である。鼻孔側から流入した流体は咽頭部側へ、咽頭部側から流入した流体は鼻孔側へ、挿入体のチューブを通して流出入可能である。そのため、鼻腔留置デバイスによって、鼻呼吸等の生理現象が阻害されにくい。また、挿入体の表面積が大きくなるので、薬剤類保持部にて薬剤類をチューブの表面のみならず裏面にも保持させることも可能になる。 According to the above configuration, since the insert is a tube having an annular cross section, when the insert is placed in the nasal cavity, fluid such as air and mucus can flow into and out of the insert. The fluid flowing in from the nostril side can flow into and out of the pharynx side, and the fluid flowing in from the pharyngeal side can flow into and out of the nostril side through the tube of the insert. Therefore, physiological phenomena such as nasal breathing are not easily inhibited by the nasal cavity placement device. In addition, since the surface area of the insert is increased, it is possible to hold the drug on the back surface as well as on the back surface of the tube in the drug holding section.
 前記鼻腔留置デバイスにおいて、前記鼻腔装着体と前記挿入体の近位端との間に開口が画成されていることが好ましい。 In the nasal cavity placement device, it is preferable that an opening is defined between the nasal cavity wearing body and the proximal end of the insertion body.
 上記構成によれば、挿入体が鼻腔に留置されたとき、鼻腔留置デバイスは、鼻孔から上記開口までの間で、鼻腔装着体に向かって粘膜が露出されている。鼻孔側から咽頭側へ向かう吸気は、その露出されている粘膜と接触した後に、上記開口から挿入体に流入する。そのため、鼻腔留置デバイスは、粘膜による吸気の加湿及び加温の生理作用を阻害しにくい。 According to the above configuration, when the insert is placed in the nasal cavity, the mucous membrane of the nasal cavity placement device is exposed from the nostril to the opening toward the nasal cavity wearing body. Inhalation from the nostril side toward the pharynx side comes into contact with the exposed mucous membrane and then flows into the insert through the opening. Therefore, the nasal cavity indwelling device hardly inhibits the physiological action of humidification and warming of inspiration by the mucous membrane.
 前記鼻腔留置デバイスにおいて、前記鼻腔装着体は、前記挿入体に向かって延出して前記挿入体の近位端に連結する支持部を備え、
 前記支持部は前記挿入体よりも剛性が大きいことが好ましい。
In the nasal cavity placement device, the nasal cavity mounting body includes a support portion that extends toward the insertion body and is connected to a proximal end of the insertion body,
It is preferable that the support portion has higher rigidity than the insert.
 上記構成によれば、挿入体を鼻孔から鼻腔に向かって挿入するとき、剛性の大きい支持部が挿入体を支持しながら、挿入体を挿入できる。そのため、挿入体を容易に鼻腔に挿入することができる。 According to the above configuration, when the insertion body is inserted from the nostril toward the nasal cavity, the insertion body can be inserted while the rigid support portion supports the insertion body. Therefore, the insert can be easily inserted into the nasal cavity.
 前記鼻腔留置デバイスにおいて、前記挿入体は、断面がU字状のチューブであることが好ましい。 In the nasal cavity placement device, the insert is preferably a tube having a U-shaped cross section.
 上記構成によれば、挿入体が鼻腔に留置されたとき、挿入体は、その長手方向に開口している部分が形成される。鼻孔側から咽頭側へ向かう吸気は、その開口している部分で粘膜と接触できる。そのため、鼻腔留置デバイスは、粘膜による吸気の加湿及び加温の生理作用を阻害しにくい。また、チューブの裏面が、長手方向に開口している部分で露出しているため、挿入体のチューブに成形した後においても、スプレー塗布等の方法により、薬剤類をチューブの裏面に容易に保持させることができる。 According to the above configuration, when the insert is placed in the nasal cavity, the insert is formed with a portion that opens in the longitudinal direction. Inhalation from the nostril side toward the pharynx side can contact the mucous membrane at the opening. Therefore, the nasal cavity indwelling device hardly inhibits the physiological action of humidification and warming of inspiration by the mucous membrane. In addition, since the back of the tube is exposed at the part that opens in the longitudinal direction, the medicines can be easily held on the back of the tube by spraying or other methods even after it is molded into the tube of the insert. Can be made.
 前記鼻腔留置デバイスにおいて、前記挿入体は、前記薬剤類保持部が設けられた薄板状部を備え、
 前記薄板状部は、前記鼻腔装着体よりも短手方向の長さが大きいことが好ましい。
In the nasal cavity indwelling device, the insert includes a thin plate-like part provided with the medicine holding part,
The thin plate-like portion preferably has a shorter length than the nasal cavity wearing body.
 上記構成によれば、挿入体が鼻腔に留置されたとき、短手方向の長さが大きい薄板状部は鼻腔内で広がっている。そのため、薄板状部に設けられている薬剤類保持部を、鼻腔の所定の位置にある粘膜に接触させることが容易となる。 According to the above configuration, when the insert is placed in the nasal cavity, the thin plate-like part having a large length in the short direction extends in the nasal cavity. Therefore, it becomes easy to bring the medicine holding part provided in the thin plate-like part into contact with the mucous membrane at a predetermined position of the nasal cavity.
 前記鼻腔留置デバイスにおいて、薄板状部は、弾性変形可能であることが好ましい。 In the nasal cavity indwelling device, the thin plate portion is preferably elastically deformable.
 上記構成によれば、挿入体を鼻孔から鼻腔に向かって挿入するとき、挿入体の薄板状部が、鼻腔の形状に合わせて弾性変形する。そのため、挿入体を容易に鼻腔に挿入することができる。 According to the above configuration, when the insert is inserted from the nostril toward the nasal cavity, the thin plate-like portion of the insert is elastically deformed according to the shape of the nasal cavity. Therefore, the insert can be easily inserted into the nasal cavity.
 前記鼻腔留置デバイスにおいて、前記薄板状部は、複数のシート状部材が互い連結して構成されていることが好ましい。 In the nasal cavity indwelling device, it is preferable that the thin plate-like portion is configured by connecting a plurality of sheet-like members to each other.
 上記構成によれば、挿入体が鼻腔に留置されたとき、所定の位置にある粘膜に対して、複数のシート状部材の各々が接触できる。そのため、薄板状部に設けられている薬剤類保持部を、複数の箇所で粘膜に接触させられる。また、単一のシート状部材で構成されている薄板状部に比べて挿入体の表面積が大きくなり、粘膜と接触する面積を大きくすることができる。さらに、シート状部材間に空隙が形成されるため、鼻呼吸等の生理現象が阻害されにくい。 According to the above configuration, when the insert is placed in the nasal cavity, each of the plurality of sheet-like members can contact the mucous membrane at a predetermined position. Therefore, the medicine holding part provided in the thin plate-like part can be brought into contact with the mucous membrane at a plurality of locations. In addition, the surface area of the inserted body is larger than that of a thin plate-shaped portion formed of a single sheet-like member, and the area in contact with the mucous membrane can be increased. Furthermore, since a gap is formed between the sheet-like members, physiological phenomena such as nasal breathing are not easily inhibited.
 前記鼻腔留置デバイスにおいて、前記薄板状部の断面は、前記薬剤類保持部が露出する表面側に向かって薄手になる形状であることが好ましい。 In the nasal cavity indwelling device, it is preferable that a cross section of the thin plate-like portion has a shape that becomes thinner toward a surface side where the medicine holding portion is exposed.
 上記構成によれば、挿入体を鼻孔から鼻腔に向かって挿入するとき、薄板状部の断面が鼻孔及び鼻腔の形状に類しており、挿入体に必要とされる変形が小さい。そのため、挿入体を容易に鼻腔に挿入することができる。また、薄板状部の形状に比較的厚手の部分があるため、その部分に薬剤類を多量に保持することができる。 According to the above configuration, when the insert is inserted from the nostril toward the nasal cavity, the cross section of the thin plate-like part is similar to the shape of the nostril and nasal cavity, and the deformation required for the insert is small. Therefore, the insert can be easily inserted into the nasal cavity. Moreover, since there is a relatively thick part in the shape of the thin plate-like part, a large amount of drugs can be held in that part.
 前記鼻腔留置デバイスにおいて、前記薄板状部の短手方向の長さは、前記遠位端に沿って小さくなることが好ましい。 In the nasal cavity placement device, it is preferable that the length of the thin plate-like portion in the short direction decreases along the distal end.
 上記構成によれば、挿入体を鼻孔から鼻腔に向かって挿入を始めるとき、挿入が始められる挿入体の遠位端側において、薄板状部は短手方向の長さが小さい。そのため、挿入体の挿入が容易に始められる。また、粘膜と接触する挿入体の近位端側において、薄板状部は短手方向の長さが大きいため、薄板状部に設けられている薬剤類保持部は、所定の位置にある粘膜に接触させることが容易となる。 According to the above configuration, when the insertion body is started to be inserted from the nostril toward the nasal cavity, the thin plate-like portion has a short length in the short direction on the distal end side of the insertion body where the insertion is started. Therefore, the insertion of the insert can be easily started. Further, on the proximal end side of the insert that comes into contact with the mucous membrane, since the thin plate-like portion has a large length in the short direction, the medicine holding portion provided in the thin plate-like portion is attached to the mucosa in a predetermined position. It becomes easy to make it contact.
 前記鼻腔留置デバイスにおいて、前記鼻腔装着体は、前記挿入体の近位端に連結して、前記挿入体に挿管される支持部を備え、
 前記支持部は、前記挿入体よりも剛性が大きいことが好ましい。
In the nasal cavity indwelling device, the nasal cavity mounting body includes a support portion that is connected to a proximal end of the insert and is intubated into the insert.
It is preferable that the support portion has higher rigidity than the insert.
 上記構成によれば、挿入体を鼻孔から鼻腔に向かって挿入するとき、剛性の大きい支持部が挿入体を支持しながら、挿入体を挿入できる。そのため、挿入体を容易に鼻腔に挿入することができる。 According to the above configuration, when the insertion body is inserted from the nostril toward the nasal cavity, the insertion body can be inserted while the rigid support portion supports the insertion body. Therefore, the insert can be easily inserted into the nasal cavity.
 前記鼻腔留置デバイスにおいて、前記鼻腔装着体は、互いに対向する一対の挟持部と、該一対の挟持部を連結する、弾性変形可能な連結部と、を備えることが好ましい。 In the nasal cavity placement device, it is preferable that the nasal cavity wearing body includes a pair of sandwiching portions facing each other and an elastically deformable coupling portion that couples the pair of sandwiching portions.
 上記構成によれば、挿入体が鼻腔に留置されたとき、手指等により鼻腔装着体の一対の挟持部を鼻柱又は鼻翼を挟んで配置する。配置された一対の挟持部は、それらを連結する連結部の弾性力により鼻柱又は鼻翼を挟持する。そのため、連結する鼻腔装着体を介して、挿入体を鼻腔に留置された状態に安定して装着させることができる。 According to the above configuration, when the insert is placed in the nasal cavity, the pair of holding parts of the nasal cavity wearing body is placed with the nose column or nose wings sandwiched between fingers or the like. A pair of arranged clamping parts clamp a nasal column or a nasal wing with the elastic force of the connection part which connects them. Therefore, the insertion body can be stably mounted in a state of being placed in the nasal cavity via the nasal cavity mounting body to be connected.
 前記鼻腔留置デバイスにおいて、前記鼻腔装着体は、円形状の外周を有する係止部を備え、
 前記係止部は、前記挿入体の留置時に鼻前庭に係止されることが好ましい。
In the nasal cavity indwelling device, the nasal cavity wearing body includes a locking portion having a circular outer periphery,
It is preferable that the locking portion is locked to the nasal vestibule when the insert is placed.
 上記構成によれば、挿入体が鼻腔に留置されたとき、鼻腔装着体は、鼻前庭において、その係止部が係止される。そのため、鼻柱や鼻翼へ負荷を与えることがなく、鼻孔に対する違和感を抑えることもできる。また、鼻腔装着体の全体を、鼻孔から抜き出せる程度において鼻腔内に留置させることも可能であるため、その場合には、鼻腔留置デバイスが鼻腔外部に露出されない。 According to the above configuration, when the insert is placed in the nasal cavity, the locking part of the nasal cavity mounting body is locked in the nasal vestibule. Therefore, it is possible to suppress a sense of incongruity with the nostril without applying a load to the nose column or wing. Further, since the entire nasal cavity wearing body can be placed in the nasal cavity to such an extent that it can be extracted from the nostril, in that case, the nasal cavity placement device is not exposed outside the nasal cavity.
 前記鼻腔留置デバイスにおいて、前記鼻腔装着体は、断面がC字状のバネ状部材であることが好ましい。 In the nasal cavity placement device, the nasal cavity mounting body is preferably a spring-like member having a C-shaped cross section.
 上記構成によれば、挿入体をその近位端から鼻孔から鼻腔に向かって挿入するとき、C字状のバネ部材である鼻腔装着体は、バネ部材に手指等により外力を与えて閉じた状態で鼻腔へ挿入する。挿入した後に、バネ部材に与えていた外力を開放して開き、開いたバネ部材が、鼻前庭又は鼻孔において係止する。そのため、鼻前庭及び鼻孔の任意の位置で係止することができる。 According to the above configuration, when the insertion body is inserted from the proximal end toward the nasal cavity from the nostril, the nasal cavity mounting body, which is a C-shaped spring member, is closed by applying an external force to the spring member with fingers or the like. To insert into the nasal cavity. After the insertion, the external force applied to the spring member is released and opened, and the open spring member is locked in the nasal vestibule or nostril. Therefore, it can be locked at any position in the nasal vestibule and nostril.
 前記鼻腔留置デバイスにおいて、前記粘膜は、少なくともキーゼルバッハ部位を含むことが好ましい。 In the nasal cavity placement device, the mucous membrane preferably includes at least a kieselbach region.
 上記構成によれば、挿入体が鼻腔に留置されたとき、挿入体の接触表面とキーゼルバッハ部位とが接触する。キーゼルバッハ部位は、その部位の粘膜下に静脈が集中しているため、薬剤類の吸収性が高い。そのため、保持されている薬剤類の吸収性を向上させることができる。 According to the above configuration, when the insert is placed in the nasal cavity, the contact surface of the insert comes into contact with the kieselbach region. In the Kieselbach region, veins are concentrated under the mucous membrane of the region, so that the absorbability of drugs is high. Therefore, the absorbability of the held medicines can be improved.
 前記鼻腔留置デバイスにおいて、前記薬剤類保持部は、多孔性構造を有することが好ましい。 In the nasal cavity indwelling device, it is preferable that the medicine holding part has a porous structure.
 上記構成によれば、挿入体に薬剤類を保持させるとき、多孔性構造を有する薬剤類保持部が、薬剤類をその多孔部に吸収して保持する。そのため、薬剤類をより多量に保持することができる。 According to the above configuration, when the drug is held in the insert, the drug holding part having a porous structure absorbs and holds the drug in the porous part. Therefore, a larger amount of drugs can be retained.
 前記鼻腔留置デバイスにおいて、前記薬剤類保持部は、マトリクス構造を有することが好ましい。 In the nasal cavity indwelling device, the medicine holding unit preferably has a matrix structure.
 上記構成によれば、挿入体が鼻腔に留置されたとき、薬剤類保持部が露出している表面から、その表面が接触している粘膜へマトリクス構造を通して薬剤類が吸収される。マトリクス構造は、薬剤類の吸収速度を緩和する効果を有する。そのため、薬剤類が粘膜に吸収されている時間を延長することができる。また、マトリクス構造は、モノマー及び/又はポリマーを重合反応させることによって架橋構造として形成されている。そのため、その重合反応の反応条件(例えば、反応温度、モノマーやポリマーの組成、濃度)を所定の条件とすることにより、架橋構造の良好な再現性を得て、鼻腔留置デバイス間の吸収速度のバラツキを抑えることができる。 According to the above configuration, when the insert is placed in the nasal cavity, the drug is absorbed through the matrix structure from the surface where the drug holding portion is exposed to the mucosa where the surface is in contact. The matrix structure has an effect of relaxing the absorption rate of drugs. Therefore, the time for which the drugs are absorbed by the mucous membrane can be extended. The matrix structure is formed as a crosslinked structure by polymerizing monomers and / or polymers. Therefore, by setting the reaction conditions of the polymerization reaction (for example, reaction temperature, monomer and polymer composition, concentration) to a predetermined condition, good reproducibility of the cross-linked structure is obtained, and the absorption rate between the nasal indwelling devices is increased. Variations can be suppressed.
 本発明に係る鼻腔留置デバイスは、薬剤類を一定時間粘膜に接触させることが可能である。 The nasal cavity indwelling device according to the present invention is capable of bringing drugs into contact with the mucous membrane for a certain period of time.
(A)本発明の実施の形態1に係る鼻腔留置デバイスの一例を模式的に示す正面図である。(B)左側面図である。(A) It is a front view which shows typically an example of the nasal cavity indwelling device which concerns on Embodiment 1 of this invention. (B) It is a left view. 本発明の実施の形態1に係るC字状のバネ部材が鼻に用いられた状態の一例を模式的に示す図である。It is a figure which shows typically an example of the state by which the C-shaped spring member which concerns on Embodiment 1 of this invention was used for the nose. (A)本発明の実施の形態1に係る挿入体が鼻腔に留置された状態の一例を模式的に示す、鼻中隔側から鼻を透視した正面図である。(B)鼻柱側から鼻を透視した図である。(C)左頬側から鼻を透視した背面図である。(A) It is the front view which looked through the nose from the nasal septum side which shows typically an example of the state by which the insert which concerns on Embodiment 1 of this invention was detained in the nasal cavity. (B) It is the figure which saw through the nose from the nasal column side. (C) It is the rear view which saw through the nose from the left cheek side. (A)本発明の実施の形態1に係る挿入体の変形例を模式的に示す正面図である。(B)左側面図である。(A) It is a front view which shows typically the modification of the insertion body which concerns on Embodiment 1 of this invention. (B) It is a left view. (A)本発明の実施の形態1に係る挿入体が鼻腔に留置された状態の変形例を模式的に示す、鼻中隔側から鼻を透視した正面図である。(B)鼻柱側から鼻を透視した図である。(C)左頬側から鼻を透視した背面図である。(A) It is the front view which looked through the nose from the nasal septum side typically showing the modification of the state where the insert concerning Embodiment 1 of the present invention was detained in the nasal cavity. (B) It is the figure which saw through the nose from the nasal column side. (C) It is the rear view which saw through the nose from the left cheek side. (A)本発明の実施の形態2に係る鼻腔留置デバイスの一例を模式的に示す正面図である。(B)左側面図である。(A) It is a front view which shows typically an example of the nasal cavity indwelling device which concerns on Embodiment 2 of this invention. (B) It is a left view. (A)本発明の実施の形態2に係る挿入体が鼻腔に留置された状態の一例を模式的に示す、鼻中隔側から鼻を透視した正面図である。(B)鼻柱側から鼻を透視した図である。(C)左頬側から鼻を透視した背面図である。(A) It is the front view which looked through the nose from the nasal septum side which shows typically an example of the state by which the insert based on Embodiment 2 of this invention was detained in the nasal cavity. (B) It is the figure which saw through the nose from the nasal column side. (C) It is the rear view which saw through the nose from the left cheek side. (A)本発明の実施の形態2に係る挿入体の変形例1を模式的に示す正面図である。(B)左側面図である。(A) It is a front view which shows typically the modification 1 of the insertion body which concerns on Embodiment 2 of this invention. (B) It is a left view. (A)本発明の実施の形態2に係る挿入体の変形例2を模式的に示す正面図である。(B)左側面図である。(A) It is a front view which shows typically the modification 2 of the insertion body which concerns on Embodiment 2 of this invention. (B) It is a left view. 本発明の実施の形態に係る鼻腔装着体の係止部が鼻前庭に係止された状態の一例を模式的に示す、正面図である。It is a front view which shows typically an example of the state by which the latching | locking part of the nasal cavity mounting body which concerns on embodiment of this invention was latched by the nasal vestibule. 本発明の実施の形態に係る鼻腔装着体の変形例を模式的に示す、正面図である。It is a front view which shows typically the modification of the nasal cavity mounting body which concerns on embodiment of this invention. 本発明の実施の形態に係る鼻腔装着体の変形例を模式的に示す、正面図である。It is a front view which shows typically the modification of the nasal cavity mounting body which concerns on embodiment of this invention. 本発明の実施の形態に係る一対の挟持部及び連結部を備える鼻腔装着体の一例を模式的に示す、斜視図である。It is a perspective view which shows typically an example of a nasal cavity mounting body provided with a pair of clamping part and connection part which concern on embodiment of this invention.
 以下、添付図面を参照しながら本発明の実施の形態に係る鼻腔留置デバイスについて詳細に説明する。ただし、実施の形態によって本発明が限定されるものではない。 Hereinafter, a nasal cavity placement device according to an embodiment of the present invention will be described in detail with reference to the accompanying drawings. However, the present invention is not limited to the embodiments.
〔実施の形態1〕
 まず、実施の形態1について説明する。この実施の形態は、挿入体がチューブである形態である。
[Embodiment 1]
First, the first embodiment will be described. In this embodiment, the insert is a tube.
(全体構成)
 最初に鼻腔留置デバイス1Aの構成について説明する。図1(A)は、実施の形態1に係る鼻腔留置デバイスの一例を模式的に示す正面図である。図1(B)は、左側面図である。図1(A)に示すように、鼻腔留置デバイス1Aは、長手方向(図1(A)のX方向)に沿って挿入体10Aと、鼻腔装着体20Aとを備え、当該長手方向で鼻腔に挿入され、鼻腔内に留置される。なお、「留置」とは、後述する薬剤類を粘膜に対して所定量及び所定時間吸収させるために必要とされる程度に留め置くことをいう。その時間は、薬剤類に応じて適宜設定され、例えば、5.0分間~30日間であり、また例えば、薬剤類がインスリンの場合には5.0分~10分であることが好ましく、さらに例えば、薬剤類がニコチンの場合3.0時間~6.0時間であることが好ましい。
(overall structure)
First, the configuration of the nasal cavity placement device 1A will be described. FIG. 1A is a front view schematically showing an example of the nasal cavity indwelling device according to the first embodiment. FIG. 1B is a left side view. As shown in FIG. 1 (A), the nasal cavity placement device 1A includes an insertion body 10A and a nasal cavity mounting body 20A along the longitudinal direction (the X direction in FIG. 1 (A)). Inserted and placed in nasal cavity. The term “indwelling” refers to the retention of drugs, which will be described later, to the extent necessary to absorb the mucous membrane for a predetermined amount and for a predetermined time. The time is appropriately set according to the drug, and is, for example, 5.0 minutes to 30 days, and preferably, for example, 5.0 minutes to 10 minutes when the drug is insulin. For example, when the drug is nicotine, the time is preferably 3.0 hours to 6.0 hours.
(構成-挿入体)
 挿入体10Aは、薬剤類保持部101と、接触表面102と、近位端103と、遠位端104と、近位端開口105と、遠位端開口106とを備える、断面環状のチューブである。以下の説明においては、鼻腔留置デバイス1Aの長手方向(図1(A)のX方向)の寸法を長さ、短手方向(図1(A)(B)のZ方向)の寸法を幅、長手方向及び単手方向に直交する方向(図1(A)(B)のY方向)の寸法を幅とする。
(Configuration-Insert)
The insert 10A is a cross-sectional annular tube comprising a drug retaining portion 101, a contact surface 102, a proximal end 103, a distal end 104, a proximal end opening 105, and a distal end opening 106. is there. In the following description, the length in the longitudinal direction (X direction in FIG. 1 (A)) of the nasal cavity placement device 1A is the length, the dimension in the short direction (Z direction in FIGS. 1 (A) and (B)) is the width, The dimension in the direction perpendicular to the longitudinal direction and the single-handed direction (the Y direction in FIGS. 1A and 1B) is defined as the width.
 挿入体10Aの長さは、例えば、10mm~80mmであることが好ましく、保持させる薬剤類を増量する場合には、30mm~80mmであることがより好ましく、50mm~80mmであることがさらに好ましい。ただし、支持体202の長さを、例えば20mm~40mmまで伸張させた場合には、保持させる薬剤類の量に合わせて挿入体10Aをこれ以下としてもよい。挿入体10Aの厚さ及び幅は、8.0mm~40mmであることが好ましい。ただし、保持させる薬剤類の量、鼻腔粘膜との接触面積に制限がない場合には、鼻腔内に留置する際の違和感を軽減させるために、これ以下としてもよい。チューブの厚み(チューブの外径の半径と内径の半径との差)は、例えば、0.1mm~5.0mmであることが好ましい。 The length of the insert 10A is preferably, for example, 10 mm to 80 mm, and more preferably 30 mm to 80 mm, and even more preferably 50 mm to 80 mm when increasing the amount of drugs to be held. However, when the length of the support 202 is extended to, for example, 20 mm to 40 mm, the insertion body 10A may be less than this in accordance with the amount of drugs to be held. The thickness and width of the insert 10A are preferably 8.0 mm to 40 mm. However, if there is no limitation on the amount of the drug to be retained and the contact area with the nasal mucosa, the amount may be less than this in order to reduce the uncomfortable feeling when placed in the nasal cavity. The thickness of the tube (the difference between the radius of the outer diameter of the tube and the radius of the inner diameter) is preferably, for example, 0.1 mm to 5.0 mm.
 挿入体10Aの材質としては、鼻腔に留置できるものであれば特に限定されず、例えば、シリコーン、熱可塑性樹脂等の樹脂が挙げられるが、高圧蒸気滅菌、エチレンオキサイドガス、γ線等による滅菌処理によって材料の劣化をさけるため、シリコーンが好ましい。 The material of the insertion body 10A is not particularly limited as long as it can be placed in the nasal cavity, and examples thereof include resins such as silicone and thermoplastic resin. High-pressure steam sterilization, ethylene oxide gas, γ-ray sterilization, etc. To avoid deterioration of the material, silicone is preferred.
 薬剤類保持部101は、薬剤類を保持可能に構成されている。例えば、薬剤類保持部101は、挿入体10Aの層中に薬剤類を内包させることで、薬剤類を保持する構成としてもよい。より具体的には、薬剤保持部101は、多孔性構造やマトリクス構造を有するようにしてもよい。 The drug holding unit 101 is configured to hold drugs. For example, the medicine holding unit 101 may be configured to hold the medicine by encapsulating the medicine in the layer of the insert 10A. More specifically, the medicine holding unit 101 may have a porous structure or a matrix structure.
 多孔性構造を有する方法としては、特に限定されないが、例えば、挿入体10A自体を多孔性体として形成する方法、及び多孔性体をチューブの外表面に接着させて挿入体とする方法が挙げられる。多孔性構造は薬剤類を保持できる多孔部を備えるものであれば特に限定されないが、その平均孔径が3.0nm~300μmであることが好ましく、疎水性分子を保持させるためには、6.0nm~10.0nmであることがより好ましい。また、多孔性構造を有している構成の場合には、挿入体10Aの柔軟性が上がり、挿入が容易となる。 The method having a porous structure is not particularly limited, and examples thereof include a method of forming the insert 10A itself as a porous body, and a method of bonding the porous body to the outer surface of the tube to form an insert. . The porous structure is not particularly limited as long as it has a porous part capable of holding drugs, but the average pore size is preferably 3.0 nm to 300 μm. In order to hold hydrophobic molecules, 6.0 nm More preferably, it is ˜10.0 nm. Further, in the case of a configuration having a porous structure, the flexibility of the insert 10A is increased and insertion is facilitated.
 なお、薬剤類保持部101は、マトリクス構造を有することにより、薬剤類を保持する構造であってもよい。マトリクス構造である場合は、鼻腔粘膜における薬剤類の吸収速度が緩和され、より長時間において薬剤類を放出し続ける。マトリクス構造を有する方法としては、特に限定されないが、例えば、挿入体自体をゾルゲル法によりマトリクス構造として形成する方法、及び挿入体の表面にポリマーを塗布し、架橋反応させる等してマトリクス構造をコーティングする方法が挙げられる。これらの方法の際には、マトリクス構造中に薬剤類を分散させる。また、挿入体の表面にマトリクス構造を形成する場合には、その厚さは、挿入部及び薬剤類保持部の柔軟性を損なわないために、5.0fm~0.1mmであることが好ましい。ただし、マトリクス構造を形成させる物質が、ゲル、ジェル等のように、薬剤類保持部と同等かそれ以上の柔軟性の場合は最大1.0mmとしてもよい。 Note that the medicine holding unit 101 may have a matrix structure to hold a medicine. In the case of the matrix structure, the absorption rate of the drugs in the nasal mucosa is reduced, and the drugs are continuously released for a longer time. A method having a matrix structure is not particularly limited. For example, a method of forming the insert itself as a matrix structure by a sol-gel method, and a method of coating the matrix structure by applying a polymer to the surface of the insert and causing a crosslinking reaction, etc. The method of doing is mentioned. In these methods, drugs are dispersed in a matrix structure. Further, when a matrix structure is formed on the surface of the insert, its thickness is preferably 5.0 fm to 0.1 mm so as not to impair the flexibility of the insertion part and the medicine holding part. However, when the substance that forms the matrix structure is as flexible as or more than the drug holding part, such as gel or gel, the maximum may be 1.0 mm.
 マトリクス構造を構成する材料は、生体安定性ポリマー及び生体吸収性ポリマーが好ましい。ここでマトリクス構造とは、ポリマーが架橋する等して複雑に絡み合った構造をいい、公知の薬品の徐放性システムのために用いられるマトリクス構造を含む構造をいう。 The material constituting the matrix structure is preferably a biostable polymer or a bioabsorbable polymer. Here, the matrix structure refers to a structure in which the polymer is intertwined in a complicated manner such as by crosslinking, and includes a matrix structure used for a known sustained-release system for drugs.
 生体吸収性ポリマーとしては、少なくともその一部が生体に吸収され得るポリマーであれば特に限定されないが、例えば、ポリカプロラクトン、ポリ(ラクチド-コ-グリコライド)、ポリ(ヒドロキシブチラート)、ポリ(ヒドロキシブチラート-コ-バリレート)、ポリジオキサノン、ポリオルソエステル、ポリアンハイドライド、ポリグリコーリック酸、ポリ(D,L)乳酸、ポリ(グリコーリック酸-コ-トリメチレンカーボネート)、ポリホスホエステル、ポリホスホエステルウレタン、ポリアミノ酸、シアノアクリレート、ポリ(トリメチレンカーボネート)、ポリ(イミノカーボネート)、コポリ(エーテル-エステル)、ポリアルキレンオギザレート、ポリホスファゼン;フィブリン、フィブリノーゲン、セルロース、アガロース、スターチ、コラーゲン、ヒアルロン酸が挙げられる。生体安定性ポリマーとしては、生体に対して安定しているポリマーであれば特に限定されないが、例えば、ポリウレタン、シリコーン、ポリエステルが挙げられる。また、その他のポリマーとして、ポリオレフィン、ポリイソブチレンと、エチレン-アルファオレフィンとの共重合体、アクリル酸ポリマーとの共重合体、ポリビニルクロライドのようなビニルハライドポリマーとの共重合体;ポリビニルメチルエーテルのようなポリビニルエーテル;ポリビニリデンフルオライド、ポリビニリデンクロライドのようなポリビニリデンハライド;ポリアクリロニトリル、ポリビニルケトン;ポリスチレンのようなポリビニルアロマチック、ポリビニルアセテートのようなポリビニルエステル;エチレン-メチルメタクリレートコポリマーのようなビニルモノマー同士又はオレフィンとの共重合体、アクリロニトリルとスチレンとの共重合体、ABS樹脂、エチレンとビニルアセテートとの共重合体;ナイロン66、ポリカプロラクタムのようなポリアミド;アルキッド樹脂;ポリカーボネート;ポリオキシメチレン;ポリイミド;ポリエーテル;エポキシ樹脂;ポリウレタン;レーヨン;レーヨントリアセテート;セルロース、セルロースアセテート、セルロースブチラート;セルロースアセテートブチラート;セロファン;セルロースナイトレート;セルロースプロピオネート;セルロースエーテル;カルボキシメチルセルロース;キチン、キトサン等もマトリクス構造に用いることができる。これらは1種単独で用いてもよく、2種以上を併用してもよい。 The bioabsorbable polymer is not particularly limited as long as at least a part of the polymer can be absorbed by the living body. For example, polycaprolactone, poly (lactide-co-glycolide), poly (hydroxybutyrate), poly ( Hydroxybutyrate-co-valerate), polydioxanone, polyorthoester, polyanhydride, polyglycolic acid, poly (D, L) lactic acid, poly (glycolic acid-co-trimethylene carbonate), polyphosphoester, polyphospho Ester urethane, polyamino acid, cyanoacrylate, poly (trimethylene carbonate), poly (iminocarbonate), copoly (ether-ester), polyalkylene oxalate, polyphosphazene; fibrin, fibrinogen, cellulose, cellulose Loin, starch, collagen, and hyaluronic acid. The biostable polymer is not particularly limited as long as it is a polymer that is stable to the living body, and examples thereof include polyurethane, silicone, and polyester. As other polymers, polyolefins, copolymers of polyisobutylene and ethylene-alpha olefins, copolymers of acrylic acid polymers, copolymers of vinyl halide polymers such as polyvinyl chloride; polyvinyl methyl ether Such as polyvinyl ether; polyvinylidene fluoride, polyvinylidene halide such as polyvinylidene chloride; polyacrylonitrile, polyvinyl ketone; polyvinyl aromatic such as polystyrene, polyvinyl ester such as polyvinyl acetate; ethylene-methyl methacrylate copolymer, etc. Copolymer of vinyl monomers or olefin, copolymer of acrylonitrile and styrene, ABS resin, copolymer of ethylene and vinyl acetate; nylon 6, Polyamides such as polycaprolactam; Alkyd resins; Polycarbonates; Polyoxymethylenes; Polyimides; Polyethers; Epoxy resins; Polyurethanes; Rayon; Rayon triacetates; Nitrate; cellulose propionate; cellulose ether; carboxymethyl cellulose; chitin, chitosan and the like can also be used for the matrix structure. These may be used alone or in combination of two or more.
 薬剤類保持部101に保持される薬剤類は、以下のものに限定されないが、例えば、医薬品、医薬部外品;各種核酸、各種ビタミン、鉄剤等の栄養補助食品が挙げられる。これらの中でも、薬剤類保持部101に保持させる容易さの観点からは、液状の薬剤類が好ましい。ここで、薬剤類には、人の身体の構造又は機能に影響を及ぼすことが目的とされている物が広く含まれる。 Drugs held in the drug holding unit 101 are not limited to the following, but include, for example, pharmaceuticals, quasi drugs; dietary supplements such as various nucleic acids, various vitamins, and iron preparations. Among these, from the viewpoint of ease of holding the drug holding unit 101, liquid drugs are preferable. Here, the medicines widely include things that are intended to affect the structure or function of the human body.
 接触表面102は、挿入体10Aの近位端103と遠位端104との間で薬剤類保持部101が露出している部分であり、本実施の形態においては、挿入体10Aの全面に形成されている。接触表面102は、留置時にその少なくとも一部が鼻腔bの粘膜と接触する。挿入体10Aは、留置時において、鼻腔装着体20Aにより近位端103で保持されているものの、遠位端104は自由端となるため、重力や挿入体10Aの形態に従って変形し、挿入体10Aの近位端103側の表面が近接する粘膜と接触する。薬剤類保持部101が挿入体10Aの表面に接触表面102として露出していれば、当該接触表面102が近接する粘膜と接触する。 The contact surface 102 is a portion where the drug holding portion 101 is exposed between the proximal end 103 and the distal end 104 of the insert 10A. In the present embodiment, the contact surface 102 is formed on the entire surface of the insert 10A. Has been. At least a part of the contact surface 102 comes into contact with the mucous membrane of the nasal cavity b during placement. The insertion body 10A is held at the proximal end 103 by the nasal cavity mounting body 20A at the time of indwelling, but the distal end 104 becomes a free end, so that the insertion body 10A is deformed according to gravity and the shape of the insertion body 10A. The surface on the proximal end 103 side of this is in contact with the adjacent mucosa. If the medicine holding part 101 is exposed as the contact surface 102 on the surface of the insert 10A, the contact surface 102 comes into contact with the adjacent mucosa.
 近位端103と遠位端104は、挿入体10Aの長手方向の両端部であり、鼻腔留置デバイス1Aの留置時に、近位端103は、鼻孔(図3(A)h)側に配置され、遠位端104は咽頭(図3(A)i)側に配置される。また、挿入体10Aは、その断面が環状のチューブであり、近位端103側に近位端開口105を有しており、遠位端104側に遠位端開口106を有している。 The proximal end 103 and the distal end 104 are both ends in the longitudinal direction of the insert 10A. When the nasal cavity placement device 1A is placed, the proximal end 103 is disposed on the nostril (FIG. 3 (A) h) side. The distal end 104 is arranged on the pharynx (FIG. 3 (A) i) side. The insert 10A is a tube having a circular cross section, and has a proximal end opening 105 on the proximal end 103 side and a distal end opening 106 on the distal end 104 side.
 ここで、断面が環状とは、断面が円形又は略円形であればよい。断面が円形又は略円形であれば、挿入体を鼻腔へ挿入するときに発生する摩擦が小さことに起因して、より滑らかに挿入体を鼻腔へ挿入できる傾向にある。 Here, the section being circular may be circular or substantially circular in cross section. If the cross section is circular or substantially circular, there is a tendency that the insert can be more smoothly inserted into the nasal cavity due to the small friction generated when the insert is inserted into the nasal cavity.
(構成-鼻腔装着体)
 鼻腔装着体20Aは、挿入体10Aを鼻腔bに装着させるために、鼻腔留置デバイス1Aに備えられている。鼻腔装着体20Aは、断面がC字状のバネ状部材201と、支持体202とを備える。バネ状部材201は、挿入体10Aの留置時に、鼻前庭の位置で係止しているため、鼻腔b外の部位に対して負荷をかけずに係止している。
(Configuration-nasal cavity body)
The nasal cavity mounting body 20A is provided in the nasal cavity placement device 1A in order to mount the insert 10A on the nasal cavity b. The nasal cavity mounting body 20 </ b> A includes a spring-like member 201 having a C-shaped cross section and a support body 202. Since the spring-like member 201 is locked at the position of the nasal vestibule when the insertion body 10A is indwelled, the spring-like member 201 is locked without applying a load to the site outside the nasal cavity b.
 図2は、実施の形態1に係るバネ部材201が鼻に用いられた状態の一例を模式的に示す図である。バネ状部材201は、断面がC字状の弾性体である。バネ部材201は、鼻翼k及び鼻柱jを内側から押圧することにより、挿入体10Aを鼻腔内で係止する。バネ状部材201は、例えばバネ鋼で形成される。 FIG. 2 is a diagram schematically illustrating an example of a state in which the spring member 201 according to the first embodiment is used for the nose. The spring-like member 201 is an elastic body having a C-shaped cross section. The spring member 201 locks the insert 10A in the nasal cavity by pressing the nasal wing k and the nasal column j from the inside. The spring-like member 201 is made of spring steel, for example.
 支持部202は、挿入体10Aに向かって長手方向に延出して挿入体10Aの近位端103に連結している。この支持部202は、挿入体10Aよりも剛性が大きい。 The support portion 202 extends in the longitudinal direction toward the insert 10A and is connected to the proximal end 103 of the insert 10A. This support portion 202 has higher rigidity than the insert 10A.
 支持部202の材質は、挿入体10Aよりも剛性が大きいもの適宜選択可能である。例えばポリプロピレンが挙げられる。挿入体10Aと連結する方法に特に限定はないが、例えば、支持部202を挿入体10Aに挿管する方法、支持部202と挿入体10Aとの各々の端部に接着又は接合させる方法、支持部202と挿入体10Aとを一体的に形成する方法が挙げられる。 The material of the support portion 202 can be selected as appropriate as long as it has higher rigidity than the insert 10A. An example is polypropylene. Although there is no particular limitation on the method of connecting to the insert 10A, for example, a method of intubating the support 202 into the insert 10A, a method of adhering or joining each end of the support 202 and the insert 10A, a support A method of integrally forming 202 and the insert 10 </ b> A may be mentioned.
 支持部202の形状は、特に限定されないが、剛性を大きくする形状であることが好ましく、例えば中実の棒状である。支持部202は、長さが例えば、1.0mm~15mmである。ただし、挿入体10Aの質量が5000mg以上の場合は、挿入体10Aと支持部202とが剥離、脱落することを防ぐため、支持部202の長さを15mm以上とすることが望ましい。また、断面が略円形である場合に外径は、例えば、8.0mm~20mmである。なお、支持部202を挿入体10Aに挿管して用いる場合には、長さは、挿管されている分だけ長くなる。
(使用方法)
The shape of the support portion 202 is not particularly limited, but is preferably a shape that increases rigidity, for example, a solid bar shape. The support portion 202 has a length of, for example, 1.0 mm to 15 mm. However, when the mass of the insert 10A is 5000 mg or more, it is desirable that the length of the support 202 is 15 mm or more in order to prevent the insert 10A and the support 202 from peeling off and dropping off. Further, when the cross section is substantially circular, the outer diameter is, for example, 8.0 mm to 20 mm. Note that when the support portion 202 is intubated and used in the insertion body 10A, the length is increased by the amount of intubation.
(how to use)
 次に図3を用いて、鼻腔留置デバイス1Aの使用方法を説明する。ここで、図3(A)は、実施の形態1に係る挿入体10Aが鼻腔bに留置された状態の一例を模式的に示す、鼻中隔側から鼻を透視した正面図である。図3(B)は、鼻柱側から鼻を透視した図である。図3(C)は、左頬側から鼻を透視した背面図である。 Next, a method of using the nasal cavity placement device 1A will be described with reference to FIG. Here, FIG. 3 (A) is a front view seen through the nose from the nasal septum side, schematically showing an example of a state in which the insert 10A according to Embodiment 1 is placed in the nasal cavity b. FIG. 3B is a perspective view of the nose from the nasal column side. FIG. 3C is a rear view seen through the nose from the left cheek side.
 図3(A)~(C)において、鼻の各部位として、副鼻腔a、鼻腔b、キーゼルバッハ部位c、中鼻甲介d、下鼻甲介e、下鼻道f、上唇g、鼻孔h、咽頭i、鼻柱j、鼻翼k、鼻尖部lを示す。 3 (A) to 3 (C), each part of the nose includes the paranasal sinus a, the nasal cavity b, the kieselbach c, the middle turbinate d, the lower nasal turbinate e, the lower nasal passage f, the upper lip g, the nostril h, and the pharynx. i, nasal column j, nose wing k, and nose tip l are shown.
 まず、挿入体10Aの遠位端104側を手にとり、鼻孔hにあてがう。次に、鼻孔hから挿入体10Aが外れないよう抑えつつ、鼻腔装着体20Aを手にとり、挿入体10Aを鼻腔bへ挿入していく。挿入体10Aの遠位端104を鼻孔hから鼻腔bへ挿入するとき、鼻腔留置デバイス1Aの鼻腔装着体20Aを把持しつつ挿入する。そうすると、鼻腔装着体20Aの支持部202が連結している近位端103を通じて挿入体10Aに外力が働き、挿入体10Aは鼻腔b内に挿入される。このとき、支持部202は挿入体10Aよりも剛性が大きいため、挿入時に支持部202が曲がってしまうようなことがなく、外力を効率的に挿入体10Aに伝達することができる。 First, the distal end 104 side of the insert 10A is picked up and applied to the nostril h. Next, while preventing the insertion body 10A from being removed from the nostril h, the nasal cavity mounting body 20A is picked up and the insertion body 10A is inserted into the nasal cavity b. When the distal end 104 of the insertion body 10A is inserted from the nostril h into the nasal cavity b, the insertion is performed while grasping the nasal cavity mounting body 20A of the nasal cavity placement device 1A. Then, an external force acts on the insertion body 10A through the proximal end 103 to which the support portion 202 of the nasal cavity mounting body 20A is connected, and the insertion body 10A is inserted into the nasal cavity b. At this time, since the support portion 202 is larger in rigidity than the insertion body 10A, the support portion 202 is not bent at the time of insertion, and an external force can be efficiently transmitted to the insertion body 10A.
 挿入体10Aを鼻腔bへ挿入の際は、バネ状部材201を手指の外力により閉じた形状としつつ、バネ状部材201も鼻孔hから挿入していく。そうすると、自然と手指がバネ状部材201から外れ、バネ状部材201は外力から開放されて開いた形状となる。開いたバネ状部材201は、鼻前庭又は鼻孔hで開いて止まり、挿入体10Aを係止する。その後、所定時間留置した後において鼻腔留置デバイス1Aを引き抜く際には、直接バネ状部材201を掴んで引き抜くことができる。 When inserting the insertion body 10A into the nasal cavity b, the spring-like member 201 is inserted from the nostril h while the spring-like member 201 is closed by the external force of the fingers. If it does so, fingers will remove | deviate from the spring-shaped member 201 naturally, and the spring-shaped member 201 will be open | released from an external force and will become an open shape. The opened spring-like member 201 opens and stops in the nasal vestibule or nostril h, and locks the insert 10A. Thereafter, when the nasal cavity indwelling device 1A is pulled out after being left for a predetermined time, the spring-like member 201 can be directly grasped and pulled out.
 これにより、図3(A)~(C)に示すように、挿入体10Aは、鼻孔hから鼻腔bに挿入され鼻腔bに留置される。鼻腔留置デバイス1Aは、咽頭iには至っていない。 Thereby, as shown in FIGS. 3A to 3C, the insertion body 10A is inserted into the nasal cavity b from the nostril h and placed in the nasal cavity b. The nasal cavity placement device 1A does not reach the pharynx i.
 本実施形態においては、接触表面102は、キーゼルバッハ部位cの粘膜と接触する。キーゼルバッハ部位cは、その部位の粘膜下に静脈が集中しているため、そうでない鼻腔bの粘膜と比較して、薬剤類の吸収速度が速い傾向があり、薬剤類保持部101を接触させる箇所として好ましい。 In the present embodiment, the contact surface 102 is in contact with the mucous membrane of the kieselbach site c. The Kieselbach region c has a concentration of veins under the mucous membrane of the region, and therefore, the absorption rate of the drugs tends to be higher than that of the mucous membrane of the nasal cavity b. As preferred.
 図3(A)~(C)に示すように、挿入体10Aが環状のチューブであるため、挿入体10Aが鼻腔に留置された状態においても、近位端開口105と遠位端開口106との間で空気、粘液等の流体が挿入体10Aに流出入し、鼻呼吸等の生理作用を阻害しにくい。 As shown in FIGS. 3A to 3C, since the insert 10A is an annular tube, even when the insert 10A is placed in the nasal cavity, the proximal end opening 105, the distal end opening 106, In between, fluids such as air and mucus flow into and out of the insertion body 10A, and physiological actions such as nasal breathing are unlikely to be hindered.
 近位端開口105は、図3(A)~(C)に示すように、キーゼルバッハ部位cに配置され、開口105から、挿入体10Aに空気、粘膜等の流体が流入する。空気の場合には、鼻孔から開口105までの間に粘膜が露出されているため、鼻孔hから咽頭iへ向かう吸気は、その露出されている粘膜と接触し、加温及び加湿される。 As shown in FIGS. 3A to 3C, the proximal end opening 105 is disposed in the kieselbach part c, and fluid such as air and mucous membrane flows from the opening 105 into the insert 10A. In the case of air, since the mucous membrane is exposed between the nostril and the opening 105, the inspiration from the nostril h to the pharynx i comes into contact with the exposed mucous membrane and is heated and humidified.
 また、粘膜と薬剤類保持部とを長時間接触させることができるため、特定の薬剤類を用いた場合に、特有の効果を奏する。例えば、消化管吸収性が低い水溶性薬剤を薬剤類として用いた場合には、低い吸収性であっても長期間吸収を持続させられるため、十分な治療的効果を望むことができる。他にも、吸収速度が速く体内で速やかに代謝されるが、高濃度では人体に有害となる場合では、本実施の形態の鼻腔留置デバイスを一度用いれば、薬剤類が少量ずつ徐放され、安全にその薬効を持続させることができる。 Also, since the mucous membrane and the drug holding part can be brought into contact with each other for a long time, a specific effect is exhibited when a specific drug is used. For example, when a water-soluble drug having low gastrointestinal absorbability is used as a drug, even if it is low absorbable, absorption can be maintained for a long period of time, so that a sufficient therapeutic effect can be desired. In addition, the absorption rate is fast and metabolized quickly in the body, but if it is harmful to the human body at high concentrations, once the nasal indwelling device of this embodiment is used, the drugs are gradually released in small amounts, Its medicinal properties can be maintained safely.
〔実施の形態1に対する変形例〕
 以上、実施の形態1について説明したが、実施の形態1の具体的な構成及び手段は、特許請求の範囲に記載した各発明の技術的思想の範囲内において、任意に改変及び改良することができる。以下、このような変形例について説明する。
[Modification to Embodiment 1]
Although the first embodiment has been described above, the specific configuration and means of the first embodiment can be arbitrarily modified and improved within the scope of the technical idea of each invention described in the claims. it can. Hereinafter, such a modification will be described.
(挿入体について)
 図4(A)は、実施の形態1に係る挿入体の変形例を模式的に示す正面図である。図4(B)は、左側面図である。図5(A)は、実施の形態1に係る挿入体が鼻腔に留置された状態の変形例を模式的に示す、鼻中隔側から鼻を透視した正面図である。図5(B)は、鼻柱側から鼻を透視した図である。図5(C)は、左頬側から鼻を透視した背面図である。
(About the insert)
FIG. 4A is a front view schematically showing a modification of the insert according to the first embodiment. FIG. 4B is a left side view. FIG. 5 (A) is a front view seen through the nose from the nasal septum side, schematically showing a modification of the state in which the insert according to Embodiment 1 is placed in the nasal cavity. FIG. 5B is a perspective view of the nose from the nasal column side. FIG. 5C is a rear view of the nose seen through from the left cheek side.
 上記実施の形態1では、断面が環状のチューブである挿入体を説明したが、これに限られず、例えば、図4(B)に示すように、断面がU字状のチューブである挿入体10Bであってもよい。なお、U字状とは、厳密にU字である必要はなく、例えば、V字、C字の形状をも含む。 In Embodiment 1 described above, the insert having a tube with an annular cross section has been described. However, the present invention is not limited to this, and for example, as shown in FIG. 4B, the insert 10B having a U-shaped cross section. It may be. The U-shape does not need to be strictly U-shaped, and includes, for example, V-shape and C-shape.
 挿入体10Bは、断面がU字状のチューブであることにより、挿入体10Bが鼻腔に留置されたとき、挿入体10Bには、長手方向に沿って開口部が形成される。開口部があるため留置時に粘膜による吸気の加湿及び加温の生理作用がより阻害されにくい。また開口部を開くことで、挿入体10Bのチューブの裏面を容易に露出させることができるため、薬剤類を裏面に塗布することも容易である。 Since the insert 10B is a tube having a U-shaped cross section, when the insert 10B is placed in the nasal cavity, an opening is formed in the insert 10B along the longitudinal direction. Since there is an opening, the physiological action of humidification and warming of inhalation by the mucous membrane during placement is more difficult to be inhibited. Moreover, since the back surface of the tube of the insertion body 10B can be easily exposed by opening the opening, it is easy to apply drugs to the back surface.
 図4(A)に示すように、バネ状部材201aは、挿入体10Bに対して所定角度傾いて配設されている。これにより鼻腔の形状により適合させることができ、留置時の違和感を緩和できる。 As shown in FIG. 4A, the spring-like member 201a is disposed at a predetermined angle with respect to the insert 10B. Thereby, it can be adapted to the shape of the nasal cavity, and the uncomfortable feeling at the time of placement can be alleviated.
 また、図4(A)に示すように、支持体202aは、挿入体10Bに挿管されている。これにより、挿入体10Bの剛性が大きくなり、鼻腔への挿入中に挿入体10Bが曲がってしまう等を抑制できる。 Further, as shown in FIG. 4A, the support 202a is intubated into the insert 10B. As a result, the rigidity of the insertion body 10B is increased, and bending of the insertion body 10B during insertion into the nasal cavity can be suppressed.
 また例えば、挿入体の断面形状は、叙述した環状及びU字状に限られるものではない。環状を変形した形状として、例えば、三角形、四角形、五角形の多角形;凹状、凸状の凹凸を有する形状等であってもよい。 Also, for example, the cross-sectional shape of the insert is not limited to the described annular and U-shape. The shape obtained by deforming the annular shape may be, for example, a triangle, a quadrangle, a pentagonal polygon; a shape having a concave shape or a convex shape.
 また例えば、挿入体は、チューブであれば特に限定されず、長手方向にスリットの入ったチューブであってもよい。チューブにスリットを形成する方法としては、例えば、チューブを作製後にその一部を切り除く方法、シートを巻いて成形しつつ、巻いた方向にシートの端部同士を接着させずに、その端部同士の間をスリットとする方法が挙げられる。 For example, the insert is not particularly limited as long as it is a tube, and may be a tube having a slit in the longitudinal direction. As a method of forming a slit in the tube, for example, a method of cutting out a part of the tube after manufacturing the tube, forming the sheet by winding the sheet, without bonding the ends of the sheet to each other in the wound direction There is a method in which a slit is provided between them.
 また例えば、上記実施の形態においては、挿入体の長さは、留置時の違和感を軽減するため、咽頭iにまで至っていないが、例えば、咽頭iの粘膜にも薬剤類を接触させるような要請がある場合は、挿入体の長さを咽頭iに至るようにしてもよい。 Further, for example, in the above embodiment, the length of the insert does not reach the pharynx i in order to reduce the uncomfortable feeling at the time of placement. If there is, the length of the insert may reach the pharynx i.
 また、例えば、薬剤類保持部101に薬剤類を保持可能にする方法は、特に限定されない。例えば、チューブの表面に薬剤類をスプレー等により塗布する方法、チューブを多孔体として形成し、そのチューブが流体の薬剤類を保持する方法、一定の透過性を有する材料でチューブを形成し、チューブの内側に薬剤類を包含させる方法、及びチューブ自体を薬剤類の材料により成形する方法が挙げられる。チューブの表面に薬剤類を塗布する方法においては、チューブの表面のみならず、裏面や内部にも薬剤類を保持させることにより、より多量に薬剤類を保持できる。 In addition, for example, a method for enabling the drug holding unit 101 to hold the drug is not particularly limited. For example, a method of applying drugs to the surface of the tube by spraying, a method of forming the tube as a porous body, a method of holding the drug of fluid in the tube, a tube made of a material having a certain permeability, and a tube And a method of including the drug inside the tube and a method of forming the tube itself from the material of the drug. In the method of applying a drug to the surface of the tube, a larger amount of the drug can be held by holding the drug not only on the surface of the tube but also on the back and inside.
 また上記実施の形態1では、接触表面102から鼻腔bの粘膜からのみ薬剤類を吸収させる例を説明したが、これに限られない。例えば、接触表面102から薬剤類の少なくとも一部が、体温で温められること又は粘膜から分泌される粘液により薬剤類保持部101から徐々に流出し、咽頭iへ流れて消化管へ投与されていってもよい。 In the first embodiment, the example in which the drugs are absorbed only from the contact surface 102 through the mucous membrane of the nasal cavity b has been described. However, the present invention is not limited to this. For example, at least a part of the drug from the contact surface 102 is gradually discharged from the drug holding part 101 due to warming at body temperature or mucus secreted from the mucous membrane, and flows to the pharynx i to be administered to the digestive tract. May be.
 また、上記実施の形態1では、薬剤類保持部101は、その全てが挿入体10Aの接触表面102として挿入体10Aの全面に露出している例を説明したが、これに限られない。例えば、薬剤類保持部101の一部が挿入体10Aの一部に接触表面102として露出していてもよい。例えば、薬剤類保持部101が挿入体10Aに内包されており、その一部が接触表面102として露出している構成が挙げられる。薬剤類保持部101の全体が露出していないことにより、薬剤類を粘膜に吸収させる速度を緩和することができる。 In the first embodiment, the example in which all of the medicine holding unit 101 is exposed as the contact surface 102 of the insert 10A on the entire surface of the insert 10A has been described, but is not limited thereto. For example, a part of the medicine holding unit 101 may be exposed as a contact surface 102 on a part of the insertion body 10A. For example, the medicine holding part 101 is included in the insertion body 10 </ b> A, and a part of the medicine holding part 101 is exposed as the contact surface 102. Since the entire medicine holding unit 101 is not exposed, the speed at which the medicine is absorbed by the mucous membrane can be reduced.
〔実施の形態2〕
 次に、実施の形態2について説明する。この実施の形態は、挿入体が薄板状部を備える形態であって、実施の形態1とは挿入体の形状が異なる。なお、実施の形態1の構成と略同一の構成についてはこの実施の形態1で用いたものと同一の符号及び/又は名称を必要に応じて付して、その説明を省略する。
[Embodiment 2]
Next, a second embodiment will be described. In this embodiment, the insert includes a thin plate portion, and the shape of the insert is different from that of the first embodiment. In addition, about the structure substantially the same as the structure of Embodiment 1, the code | symbol and / or name which are the same as what was used in this Embodiment 1 are attached | subjected as needed, and the description is abbreviate | omitted.
(構成)
 最初に鼻腔留置デバイス2Aの構成について図6及び図7を用いて説明する。ここで、図6(A)は、実施の形態2に係る鼻腔留置デバイスの一例を模式的に示す正面図である。また、図6(B)は、その左側面図である。図7(A)は、実施の形態2に係る挿入体が鼻腔に留置された状態の一例を模式的に示す、鼻中隔側から鼻を透視した正面図である。図7(B)は、鼻柱側から鼻を透視した図である。図7(C)は、左頬側から鼻を透視した背面図である。
(Constitution)
First, the configuration of the nasal cavity placement device 2A will be described with reference to FIGS. Here, FIG. 6A is a front view schematically showing an example of the nasal cavity indwelling device according to the second embodiment. FIG. 6B is a left side view thereof. FIG. 7A is a front view seen through the nose from the nasal septum side, schematically showing an example of a state in which the insert according to Embodiment 2 is placed in the nasal cavity. FIG. 7B is a view seen through the nose from the nasal column side. FIG. 7C is a rear view seen through the nose from the left cheek side.
(構成-挿入体)
 図6(A)に示すように、鼻腔留置デバイス2Aは、挿入体11Aと、鼻腔装着体20Bとを備える。挿入体11Aは、薬剤類保持部101が設けられた薄板状部110と、長手方向に近位端103及び遠位端104とを備える。図6(A)に示すように、薄板状部は、鼻腔装着体20Bよりも短手方向の長さが大きい。そのため、挿入体11Aが鼻腔に留置された状態において(図7(A)~(C)参照)、挿入体11Aの薄板状部110が鼻腔b内で大きく広がり、薄板状部110に設けられている薬剤類保持部101を、鼻腔b内の粘膜により大きい面積で接触可能になる。
(Configuration-Insert)
As shown in FIG. 6A, the nasal cavity indwelling device 2A includes an insert 11A and a nasal cavity mounting body 20B. The insert 11A includes a thin plate-like portion 110 provided with a medicine holding portion 101, and a proximal end 103 and a distal end 104 in the longitudinal direction. As shown in FIG. 6A, the thin plate-like portion is longer in the short direction than the nasal cavity mounting body 20B. Therefore, in a state where the insert 11A is placed in the nasal cavity (see FIGS. 7A to 7C), the thin plate-like portion 110 of the insert 11A extends widely in the nasal cavity b and is provided in the thin plate-like portion 110. The medicinal product holding part 101 can be brought into contact with the mucous membrane in the nasal cavity b in a larger area.
 薄板状部110は、弾性変形可能な材質である。ここで、弾性変形可能とは、挿入体11Aを鼻孔hから鼻腔bまで挿入する間に、必要とされる変形が可能な程度に弾性を有することをいう。弾性変形可能な材質とは、例えば、薄板状部110を例えばシリコーンを含むゴム等の材質で形成したものである。薄板状部110が弾性変形可能であることにより、挿入体11Aを鼻腔bに挿入するとき、鼻腔bの形状に合わせて弾性変形しながら挿入されるため、挿入が容易である。 The thin plate portion 110 is a material that can be elastically deformed. Here, the term “elastically deformable” means that the insert 11A is elastic enough to allow the required deformation while it is inserted from the nostril h to the nasal cavity b. The elastically deformable material is, for example, one in which the thin plate portion 110 is formed of a material such as rubber containing silicone. Since the thin plate-like portion 110 can be elastically deformed, when the insert 11A is inserted into the nasal cavity b, it is inserted while being elastically deformed in accordance with the shape of the nasal cavity b, so that the insertion is easy.
 薄板状部110の幅は、近位端103から挿入体11Aの長手方向略中央に沿って漸増し、該長手方向略中央から遠位端104に沿って漸減する。挿入体11Aを鼻孔hから挿入するとき、幅の狭い遠位端104から挿入していくため、挿入が容易である。 The width of the thin plate-like portion 110 gradually increases from the proximal end 103 along the approximate center in the longitudinal direction of the insert 11A, and gradually decreases along the distal end 104 from the approximately longitudinal center. When the insertion body 11A is inserted from the nostril h, the insertion is easy because the insertion is performed from the narrow distal end 104.
 薄板状部110の最大幅は、鼻腔に留置されたときに、その表面が粘膜と接触できる程度の大きさであれば特に限定されない。長さは、10mm~80mmであることが好ましく、留置時の違和感を軽減させる点から、10mm~40mmであることがより好ましく、10mm~20mmであることがさらに好ましい。薄板状部110の近位端103側における幅は、8.0mm~30mmであることが好ましい。薄板状部110の遠位端104側における幅は、2.0mm~8.0mmであることが好ましい。厚さは、0.1mm~5.0mmであることが好ましい。 The maximum width of the thin plate-like portion 110 is not particularly limited as long as the surface can contact the mucous membrane when placed in the nasal cavity. The length is preferably from 10 mm to 80 mm, more preferably from 10 mm to 40 mm, and even more preferably from 10 mm to 20 mm from the viewpoint of reducing the uncomfortable feeling during placement. The width of the thin plate portion 110 on the proximal end 103 side is preferably 8.0 mm to 30 mm. The width of the thin plate portion 110 on the distal end 104 side is preferably 2.0 mm to 8.0 mm. The thickness is preferably 0.1 mm to 5.0 mm.
(構成-鼻腔装着体)
 鼻腔装着体20Bは、バネ状部材201aと、支持部202aとを備える。支持部202aは、挿入体11Aの近位端103に連結して、挿入体11Aに挿管されている。支持部202aは、挿入体11Aよりも剛性が大きい。薄板状部110を備える挿入体11Aは挿入するときの変形量が大きくなりやすいため、支持部202aは挿入体11A内まで挿管されている。
(Configuration-nasal cavity body)
The nasal cavity mounting body 20B includes a spring-like member 201a and a support portion 202a. The support portion 202a is connected to the proximal end 103 of the insert 11A and is inserted into the insert 11A. The support portion 202a has higher rigidity than the insertion body 11A. Since the insertion body 11A including the thin plate-like portion 110 tends to have a large deformation amount when inserted, the support portion 202a is intubated into the insertion body 11A.
〔実施の形態2の変形例〕
 以上、実施の形態2について説明したが、実施の形態2の具体的な構成及び手段は、特許請求の範囲に記載した各発明の技術的思想の範囲内において、任意に改変及び改良することができる。以下、このような変形例について説明する。
[Modification of Embodiment 2]
Although the second embodiment has been described above, the specific configuration and means of the second embodiment can be arbitrarily modified and improved within the scope of the technical idea of each invention described in the claims. it can. Hereinafter, such a modification will be described.
(挿入体について)
 図8(A)は、実施の形態2に係る挿入体の変形例1を模式的に示す正面図である。図8(B)は、左側面図である。上記実施の形態2では、挿入体が1枚のプレート状である形状である薄板状部を備える例を説明したが、これに限られず、図8(B)に示す挿入体11Bのように構成してもよい。すなわち、薄板状部110を、2つのシート状部材110aを厚み方向に互いに対向させて、連結部110bにより連結して構成してもよい。なお、連結するシート状部材の枚数は2枚でなくてもさらに多くともよい。
(About the insert)
FIG. 8A is a front view schematically showing Modification Example 1 of the insert according to Embodiment 2. FIG. FIG. 8B is a left side view. In the second embodiment, the example in which the insert body is provided with a thin plate-like portion having a plate-like shape has been described. However, the present invention is not limited to this, and a configuration like the insert body 11B shown in FIG. May be. That is, the thin plate-like portion 110 may be configured by connecting the two sheet-like members 110a to each other in the thickness direction and connecting them with the connecting portion 110b. It should be noted that the number of sheet-like members to be connected is not limited to two and may be larger.
 挿入体11Bは、シート状部材110aの各々が粘膜に接触しているため、より多くの箇所で薬剤類保持部101を粘膜と接触させられる。また、薄板状部110全体の表面積が増大するため、粘膜と接触する薬剤類保持部101の面積を大きくすることができる。さらに、シート状部材110aと連結部110bとの空隙が、空気等の流体が往来することができる。シート状部材110aは、挿入体11Aの薄板状部110と同様の形状及び寸法が用いられる。ただし、シート状部材110aの厚さは、連結された薄板状部全体で、0.1mm~5.0mmであることが好ましい。 In the insertion body 11B, since each of the sheet-like members 110a is in contact with the mucous membrane, the medicine holding part 101 can be brought into contact with the mucous membrane at more places. Moreover, since the surface area of the whole thin plate-shaped part 110 increases, the area of the chemical | medical agent holding | maintenance part 101 which contacts a mucous membrane can be enlarged. Further, fluid such as air can come and go through the gap between the sheet-like member 110a and the connecting portion 110b. The sheet-like member 110a has the same shape and size as the thin plate-like portion 110 of the insert 11A. However, the thickness of the sheet-like member 110a is preferably 0.1 mm to 5.0 mm in the whole connected thin plate-like portions.
 図9(A)は、実施の形態2に係る挿入体の変形例2を模式的に示す正面図である。図9(B)は、左側面図である。上記実施の形態2では、厚さが均一である薄板状部を備える例を説明したが、これに限られず、図9(B)に示す挿入体11Cのように、挿入体は、薬剤類保持部101が露出する表面102側に向かって薄手になる形状である断面を有する薄板状部を備えていてもよい。 FIG. 9 (A) is a front view schematically showing Modification Example 2 of the insert according to Embodiment 2. FIG. FIG. 9B is a left side view. In Embodiment 2 described above, an example in which a thin plate-like portion having a uniform thickness is provided has been described. However, the present invention is not limited to this, and an insert can hold a drug like an insert 11C illustrated in FIG. You may provide the thin plate-shaped part which has a cross section which is a shape which becomes thin toward the surface 102 side which the part 101 exposes.
 挿入体11Cは、挿入体11Cを鼻孔hから鼻腔bに向かって挿入するとき、薄板状部110の断面が鼻孔h及び鼻腔bの形状に類した三角形状であり、挿入体11Cに必要とされる変形が小さい。そのため、挿入体11Cを容易に鼻腔に挿入することができる。また、薄板状部の幅が大きい(厚手の)部分があるため、その部分に薬剤類を多量に保持させることができる。 When the insert 11C is inserted from the nostril h toward the nasal cavity b, the cross section of the thin plate-like portion 110 has a triangular shape similar to the shape of the nostril h and the nasal cavity b, and is required for the insert 11C. Deformation is small. Therefore, the insert 11C can be easily inserted into the nasal cavity. Moreover, since there exists a part (thick) where the width | variety of a thin-plate shaped part is large, a chemical | medical agent can be hold | maintained abundantly in the part.
〔実施の形態1及び2に対する変形例〕
 以上、実施の形態1及び2について説明したが、実施の形態1及び2の具体的な構成及び手段は、特許請求の範囲に記載した各発明の技術的思想の範囲内において、任意に改変及び改良することができる。以下、このような変形例について説明する。
[Modifications to Embodiments 1 and 2]
While the first and second embodiments have been described above, the specific configurations and means of the first and second embodiments are arbitrarily modified and modified within the scope of the technical idea of each invention described in the claims. It can be improved. Hereinafter, such a modification will be described.
(挿入体について)
 上記実施の形態1では、薬剤類保持部が挿入体の層中に薬剤類を保持する構成(多孔性構造やマトリクス構造等)について説明したが、薬剤類を保持する方法は、これに限られない。薬剤類保持部は、薬剤類を挿入体の表面上に保持するようにしてもよい。この場合、挿入体内に上述したような多孔性構造やマトリクス構造を設けなくてもよいので薬剤類保持部の構成を簡易なものとすることができる。
(About the insert)
In Embodiment 1 described above, the structure (the porous structure, the matrix structure, etc.) in which the drug holding unit holds the drug in the layer of the insert has been described. However, the method for holding the drug is limited to this. Absent. The medicine holding unit may hold the medicine on the surface of the insert. In this case, since it is not necessary to provide the porous structure or matrix structure as described above in the insertion body, the structure of the medicine holding part can be simplified.
 例えば、液状の薬剤類を挿入体の表面に直接塗布し、該液状の薬剤類と挿入体の表面との界面に働く表面張力により、該薬剤類を挿入体の表面に保持する構成にしてもよい。より具体的には、液状の薬剤類を挿入体の外表面に直接塗布する方法や、挿入体がその内表面から外表面に向けて該薬剤類を浸透させることができる材質で構成されている場合には、液状の薬剤類を挿入体の内表面に直接塗布する方法が挙げられる。 For example, the liquid medicine is directly applied to the surface of the insert, and the medicine is held on the surface of the insert by the surface tension acting on the interface between the liquid medicine and the surface of the insert. Good. More specifically, the liquid medicine is directly applied to the outer surface of the insert, or the insert is made of a material that can penetrate the medicine from the inner surface toward the outer surface. In some cases, a method of directly applying a liquid drug to the inner surface of the insert may be mentioned.
 この場合、挿入体の作製後にも所望の位置に薬剤類を直接塗布することで薬剤類保持部とすることができ、薬剤類保持部の設置箇所の自由度が格段に向上する。 In this case, it is possible to provide a medicine holding part by directly applying the medicine to a desired position even after the insertion body is manufactured, and the degree of freedom of the place where the medicine holding part is installed is greatly improved.
 液状の薬剤類としては、特に限定されないが、より高い表面張力を得る観点から、増粘剤やゲル化剤を含有する薬剤類が好ましい。ここで、「増粘剤」とは、薬剤類中に含有させることで、液状の薬剤類が粘性を帯びる原材料を意味する。また、「ゲル化剤」とは、薬剤類中に含有させることで、該薬剤類を固形化又は半固形化させることのできる原材料を意味する。なお、薬剤類には、増粘剤とゲル化剤とを組み合わせて含有させてもよいし、それぞれを単独で含有させてもよい。増粘剤の具体例としては、例えば、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース、カルボキシメチルセルロース等のセルロース誘導体;加工デンプン、キサンタンガム、グアガム、タマリンドガムが挙げられる。また、ゲル化剤の具体例としては、例えば、寒天、カラギナンが挙げられる。 The liquid drug is not particularly limited, but a drug containing a thickener or a gelling agent is preferable from the viewpoint of obtaining higher surface tension. Here, the “thickening agent” means a raw material in which a liquid drug is viscous by being contained in the drug. The “gelling agent” means a raw material that can be solidified or semi-solidified by being contained in the drug. The drugs may contain a thickener and a gelling agent in combination, or each may be contained alone. Specific examples of the thickener include cellulose derivatives such as hydroxypropylcellulose, hydroxypropylmethylcellulose and carboxymethylcellulose; modified starch, xanthan gum, guar gum and tamarind gum. Specific examples of the gelling agent include agar and carrageenan.
 また、液状の薬剤類には、上述した薬剤類の成分以外に、薬剤類の粘度を調整することや薬剤類の分散性を向上させる観点から、溶剤や分散剤をさらに含有させてもよい。溶剤としては、薬剤類中の有効成分を溶解させるものであれば特に限定されないが、例えば、水、エタノール等の1価アルコール、プロピレングリコール等のジオール(2価アルコール)、グリセリン等のトリオール(3価アルコール)が挙げられる。また、分散剤としては、薬剤類中の有効成分を分散させるものであれば特に限定されないが、例えば、水、エタノール等の1価アルコール、プロピレングリコール等のジオール(2価アルコール)、グリセリン等のトリオール(3価アルコール)、水溶性ポリマーが挙げられる。薬剤類に含有させた溶剤や分散剤は、該薬剤類を挿入体の表面上で保持させた後に、挿入体を加熱や真空乾燥する等の手段により、該薬剤類から除去することができる。このため、溶剤や分散剤を薬剤類にさらに含有させることにより、挿入体の表面上で溶剤や分散剤等の液体成分を除去し、薄膜化された状態の薬剤類を得ることができる。また、薄膜化された薬剤類は、該薬剤類と挿入体の表面との界面に働く密着力により、該薬剤類を挿入、液状の薬剤類をそのまま挿入体の表面上に保持した場合に比べて、より安定的に挿入体の表面上に薬剤類を保持できる。 In addition to the above-described components of the drug, the liquid drug may further contain a solvent and a dispersant from the viewpoint of adjusting the viscosity of the drug and improving the dispersibility of the drug. The solvent is not particularly limited as long as it dissolves an active ingredient in pharmaceuticals. For example, water, monohydric alcohols such as ethanol, diols such as propylene glycol (dihydric alcohols), triols such as glycerin (3 (Hydric alcohol). In addition, the dispersant is not particularly limited as long as it disperses the active ingredient in the drug. For example, water, a monohydric alcohol such as ethanol, a diol (dihydric alcohol) such as propylene glycol, glycerin, and the like. Examples include triol (trihydric alcohol) and water-soluble polymer. The solvent or dispersant contained in the drug can be removed from the drug by means such as heating or vacuum drying after the drug is held on the surface of the insert. For this reason, by further containing a solvent or a dispersant in the drug, liquid components such as the solvent and the dispersant can be removed on the surface of the insert, and the drug in a thinned state can be obtained. Further, the thinned drugs are compared with the case where the drugs are inserted and the liquid drugs are held on the surface of the insert as it is due to the adhesive force acting on the interface between the drugs and the surface of the insert. Thus, the drugs can be held on the surface of the insert more stably.
 また薬剤類保持部が薬剤類を挿入体の表面上に保持する方法としては、上記直接塗布に加えて、例えば、薄膜化した状態の薬剤類(フィルム製剤)を挿入体上に積層させる構成も考えられる。例えば、予め挿入体自体又は挿入体以外の中間媒体上で液状の薬剤類を加熱や真空乾燥によって該薬剤類中の液体成分を除いてフィルム製剤とした後に、接着剤や粘着剤を介して挿入体の表面上に当該フィルム製剤を積層させて薬剤類を保持する方法が挙げられる。フィルム製剤の大きさや厚みは、薬剤類の有効成分や含まれる添加剤の量や質に応じて適宜設定され、挿入体に保持させることが可能な程度のものであれば特に限定されない。なお、接着剤や粘着剤は、人体への侵襲性がなく、かつフィルム製剤が挿入体に保持させることが可能なものであれば特に限定されず、公知の材料を用いることができる。挿入体の表面上にフィルム製剤を設けることにより、挿入体の所望の位置を薬剤類保持部とすることができ、鼻腔内の所望の位置へ薬剤類を投与することが容易となる。 In addition to the direct application described above, for example, the drug holding unit holds the drug on the surface of the insert. For example, a thinned drug (film preparation) may be stacked on the insert. Conceivable. For example, a liquid drug is preliminarily removed from the insert itself or an intermediate medium other than the insert by heating or vacuum drying to form a film preparation, which is then inserted via an adhesive or adhesive. A method of holding the drugs by laminating the film preparation on the surface of the body is mentioned. The size and thickness of the film preparation are not particularly limited as long as they are appropriately set according to the amount and quality of the active ingredient of the drug and the additive contained and can be held in the insert. The adhesive and the pressure-sensitive adhesive are not particularly limited as long as they are not invasive to the human body and the film preparation can be held in the insert, and known materials can be used. By providing a film preparation on the surface of the insert, a desired position of the insert can be used as a medicine holding part, and the medicine can be easily administered to a desired position in the nasal cavity.
 接着剤としては、対象をはり合わせることができるものであれば特に限定されないが、例えば、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース、カルボキシメチルセルロース等のセルロース誘導体や、ポリビニルピロリドン、ポリビニルアルコール等を含む溶液;小麦やタピオカ由来のでんぷんを原料とする糊が挙げられる。また、粘着剤としては、はり合わせた対象を後ではがすことができるものを用いてもよい。このような粘着剤を用いることにより、フィルム製剤を挿入体の表面上で一度保持させた後で、再度、このフィルム製剤を挿入体の異なる表面上の位置に保持させることができ、鼻腔内の所望の位置へ薬剤類を投与することがより容易となる。 The adhesive is not particularly limited as long as it can bond the objects, but for example, a solution containing cellulose derivatives such as hydroxypropylcellulose, hydroxypropylmethylcellulose, carboxymethylcellulose, polyvinylpyrrolidone, polyvinyl alcohol, etc .; wheat And paste made from starch derived from tapioca. Moreover, as an adhesive, you may use what can peel off the target stuck together later. By using such an adhesive, the film preparation can be held once on the surface of the insert, and then the film preparation can be held again at a position on a different surface of the insert. It becomes easier to administer the drugs to a desired position.
 さらに、薬剤類保持部が挿入体の表面上で薬剤類を保持する構成を、挿入体の表面上に液状の薬剤類やフィルム製剤を適用するために、液体や粉末のスプレー剤を挿入体の表面に対して噴霧することにより達成してもよい。また、より強く挿入体の表面に薬剤類を保持させるため、挿入体の表面に予め上述した接着剤や粘着剤を設けておき、その表面に対してスプレー剤を噴霧してもよい。スプレー剤を噴霧により挿入体の表面上に薬剤類を設けることにより、簡易に薬剤類を保持することができる。 Furthermore, in order to apply the liquid medicine or film preparation on the surface of the insert, the liquid medicine holding part holds the medicine on the surface of the insert. It may be achieved by spraying on the surface. Further, in order to more strongly hold the drugs on the surface of the insert, the above-described adhesive or pressure-sensitive adhesive may be provided in advance on the surface of the insert, and the spray agent may be sprayed on the surface. By providing the drugs on the surface of the insert by spraying the spray, the drugs can be easily held.
 また、薬剤類は、上述したような粘着剤や接着剤に薬剤成分を含有させたものとしてもよい。このような薬剤類を上記液状の薬剤類やフィルム製剤として挿入体の表面に適用することにより、薬剤類を挿入体表面上により密着性をもたせて保持することができる。 Also, the drugs may be those in which the above-mentioned pressure-sensitive adhesive or adhesive contains a drug component. By applying such drugs to the surface of the insert as the above liquid drugs or film preparations, the drugs can be held with better adhesion on the surface of the insert.
 また例えば、薬剤保持部として、異なる種類の薬剤類が複数積層した構成を用いてもよいし、薬剤類が厚み方向に濃度勾配を有する構成を用いてもよい。例えば、挿入体の表面、接着剤、第1フィルム製剤、接着剤、第2フィルム製剤の順に設けることにより、第1フィルム製剤が有効成分を高濃度に含み、第2フィルム製剤が有効成分を低濃度に含んだ、挿入体の厚み方向に薬剤類の濃度勾配を設けてもよい。また、第1フィルム製剤が脂溶性の有効成分を含み、第2フィルム製剤が水溶性の有効成分を含んだ、異なる組成の薬剤類を順次投与するよう設計することができる。 Further, for example, as the drug holding unit, a configuration in which a plurality of different types of drugs are stacked may be used, or a structure in which the drugs have a concentration gradient in the thickness direction may be used. For example, by providing the surface of the insert, the adhesive, the first film preparation, the adhesive, and the second film preparation in this order, the first film preparation contains a high concentration of the active ingredient, and the second film preparation contains the low active ingredient. A concentration gradient of drugs may be provided in the thickness direction of the insert, which is included in the concentration. Moreover, it can design so that the 1st film formulation contains a fat-soluble active ingredient and the 2nd film formulation contains the water-soluble active ingredient, and administers the medicine of a different composition one by one.
 なお、薬剤類保持部が挿入体の表面上で薬剤類を保持する構成において、薬剤類保持部に保持される液状の薬剤類やフィルム製剤との親和性を高めて該薬剤類を保持することが容易となるよう、挿入体の外表面や内表面に表面処理を施してもよい。 In the configuration in which the drug holding unit holds the drug on the surface of the insert, the drug holding unit increases the affinity with the liquid drug or film preparation held in the drug holding unit. Surface treatment may be applied to the outer surface or inner surface of the insert so as to facilitate the process.
 表面処理としては、例えば挿入体を、公知の酸や塩基の水溶液に浸漬する処理、オゾン雰囲気下に放置する処理、シランカップリング剤及びポリマーを挿入体表面の材料と反応させる処理が挙げられる。例えば、材質がシリコーンである挿入体の表面は、該シリコーンの末端が水酸基を有することに由来して、水溶性の薬剤類との親和性が高く、脂溶性の薬剤類との親和性が低い。よって、材質がシリコーンである挿入体に対して、シランカップリング剤及びそのシランカップリング剤と反応性を有するポリマーを挿入体の表面に対して反応させることにより、挿入体の表面が脂溶性となり、脂溶性の薬剤類との親和性を高くなり、脂溶性の薬剤類をより強く保持することができる。 Examples of the surface treatment include a treatment in which the insert is immersed in an aqueous solution of a known acid or base, a treatment in which the insert is left in an ozone atmosphere, and a treatment in which a silane coupling agent and a polymer are reacted with the material on the insert surface. For example, the surface of the insert made of silicone is high in affinity with water-soluble drugs and low in affinity with fat-soluble drugs because the silicone end has a hydroxyl group. . Therefore, the surface of the insert becomes fat-soluble by reacting the insert made of silicone with the silane coupling agent and a polymer reactive with the silane coupling agent on the surface of the insert. The affinity with fat-soluble drugs can be increased, and the fat-soluble drugs can be more strongly retained.
 上記実施の形態1及び2では、1つの挿入体を備える鼻腔留置デバイスについて説明したが、これに限られず、2つの挿入体を備える鼻腔留置デバイスであってもよい。2つの挿入体は2つの鼻孔に対してそれぞれ挿入される。双方の長さ、太さ等のサイズに特に限定はなく、例えば、一方の挿入体は上述した挿入体と同程度の長さを有し、他方の挿入体は比較的短くしてもよいし、双方を同一のサイズとしてもよい。また2つの挿入体のそれぞれに薬剤類保持部を備えるようにしてもよいし、一方のみに備えるようにしてもよい。また例えば、一方の挿入体は脂溶性の薬剤類を保持する薬剤類保持部を備え、他方の挿入体は水溶性の薬剤類を保持する薬剤類保持部を備える等としてもよい。この場合には、異なる種類の薬剤類を同時に保持することができる。 In Embodiments 1 and 2 described above, the nasal cavity indwelling device including one insert has been described. However, the present invention is not limited to this, and a nasal cavity indwelling device including two inserts may be used. Two inserts are respectively inserted into the two nostrils. There is no particular limitation on the size of both the length, thickness, etc. For example, one insert may have the same length as the above-described insert, and the other insert may be relatively short. Both may have the same size. In addition, each of the two inserts may be provided with a medicine holding part, or only one of them may be provided. Further, for example, one of the inserts may include a drug holding unit that holds a fat-soluble drug, and the other insert may include a drug holding unit that holds a water-soluble drug. In this case, different types of drugs can be held simultaneously.
(鼻腔装着体について)
 図10は、実施の形態に係る鼻腔装着体の係止部が鼻前庭に係止された状態の一例を模式的に示す、正面図である。図11は、実施の形態に係る鼻腔装着体の変形例を模式的に示す、正面図である。図12は、本発明の実施の形態に係る鼻腔装着体の変形例を模式的に示す、正面図である。上記実施の形態1及び2では、断面がC字状のバネ部材である鼻腔装着体の例を説明したが、これに限られず、図10~図12に示すように、円形状の外周を有する係止部203a、203b、203cを備え、係止部203a、203b、203cが挿入体の留置時に鼻前庭に係止される鼻腔装着体であってもよい。
(About nasal cavity wearing body)
FIG. 10 is a front view schematically showing an example of a state in which the locking part of the nasal cavity mounting body according to the embodiment is locked to the nasal vestibule. FIG. 11 is a front view schematically showing a modification of the nasal cavity wearing body according to the embodiment. FIG. 12 is a front view schematically showing a modification of the nasal cavity mounting body according to the embodiment of the present invention. In the first and second embodiments, an example of a nasal cavity mounting body that is a spring member having a C-shaped cross section has been described. However, the present invention is not limited to this, and has a circular outer periphery as shown in FIGS. A nasal cavity mounting body that includes the locking portions 203a, 203b, and 203c and that is locked to the nasal vestibule when the insertion body is placed may be used.
 図10に示すように、鼻腔装着体20Cは、外径の最も大きい部分である係止部203aと、挿入方向に向かって弾性変形するスプリング204とを備える。また、鼻腔装着体20Cは、挿入体10Aと連結している。鼻腔装着体20Cは、X方向に向かって中空である略円筒形状であること好ましく、これにより挿入体10Aと合わせて、流体を鼻孔hから咽頭側へ流出入させることができる。また、鼻腔装着体20Cは、挿入体10Aと連結する端部側に係止部203aを備え、挿入体10Aと連結しない他端部側に向かって外径が小さくなっていく形状である。スプリング204は、挿入方向への外力を緩和する効果を有し、鼻腔装着体20Cが挿入され過ぎないように調整できる。 As shown in FIG. 10, the nasal cavity mounting body 20C includes a locking portion 203a that is a portion having the largest outer diameter, and a spring 204 that is elastically deformed in the insertion direction. The nasal cavity mounting body 20C is connected to the insertion body 10A. The nasal cavity mounting body 20C preferably has a substantially cylindrical shape that is hollow toward the X direction. This allows the fluid to flow into and out of the pharynx from the nostril h together with the insertion body 10A. The nasal cavity mounting body 20C is provided with a locking portion 203a on the end side connected to the insertion body 10A, and the outer diameter decreases toward the other end side not connected to the insertion body 10A. The spring 204 has an effect of reducing external force in the insertion direction, and can be adjusted so that the nasal cavity mounting body 20C is not inserted too much.
 図11に示すように、鼻腔装着体20Dは、突起状の係止部203bを複数備えること以外は、図10に示す鼻腔装着体20Cと同様に構成されている。複数の係止部203bにより鼻前庭に対してより係止力が大きくなるので、より安定して鼻腔留置デバイスを装着させることができる。 As shown in FIG. 11, the nasal cavity mounting body 20D is configured in the same manner as the nasal cavity mounting body 20C shown in FIG. 10 except that it includes a plurality of protrusion-like locking portions 203b. Since the locking force on the nasal vestibule is increased by the plurality of locking portions 203b, the nasal cavity placement device can be more stably attached.
 図12に示すように、鼻腔装着体20Eは、挿入体10Aに連結し、複数の開口205aを有する錐体部205と、この錐体部205に連結し、鼻腔装着体20Eの端部を構成する係止部203cとを備える。錐体部205の断面径は、挿入体10Aの連結端から係止部203cに向かって漸次大きくなり、最大の断面径を有する係止部203cに連結する。この形状により、鼻腔装着体20Eが指等で摘みやすいため、鼻腔留置デバイスの装着、脱着がより容易になる。開口205aは、挿入体10Aのチューブ内側に通じており、流体を鼻孔hから咽頭側へ流出入させることができる。 As shown in FIG. 12, the nasal cavity mounting body 20E is connected to the insertion body 10A and has a cone part 205 having a plurality of openings 205a, and is connected to the cone part 205 to constitute the end of the nasal cavity mounting body 20E. Engaging portion 203c. The cross-sectional diameter of the cone portion 205 gradually increases from the connecting end of the insert 10A toward the locking portion 203c, and is connected to the locking portion 203c having the maximum cross-sectional diameter. With this shape, the nasal cavity mounting body 20E can be easily picked with a finger or the like, so that the nasal cavity indwelling device can be more easily attached and detached. The opening 205a communicates with the inside of the tube of the insert 10A, and allows fluid to flow into and out of the pharynx from the nostril h.
 また例えば、鼻腔装着体は、図13に示すように、互いに対向する一対の挟持部206と、一対の挟持部206を連結する弾性変形可能な207とを備える構成であってもよい。鼻腔装着体20Fは、一対の挟持部206の挿入体10Aと連結している方が一つの鼻孔hから挿入され、他方の挟持部206がもう一方の鼻孔hに挿入される。いずれの挟持部206も、連結部207と連結しているため、その全ては鼻孔hの内部まで挿入されない。この場合には、一対の挟持部206は鼻柱jを挟んで連結部207により連結されている。これにより、鼻腔留置デバイスが鼻腔bの内部まで入りすぎて、引き抜けなくなってしまうことがない。他に、他方の挟持部206を鼻翼kの外部に配置し、一対の挟持部206が鼻翼kを挟んで連結部207により連結してもよい。 Further, for example, the nasal cavity mounting body may be configured to include a pair of sandwiching portions 206 facing each other and an elastically deformable 207 connecting the pair of sandwiching portions 206 as shown in FIG. In the nasal cavity mounting body 20F, the one connected to the insertion body 10A of the pair of holding portions 206 is inserted from one nostril h, and the other holding portion 206 is inserted into the other nostril h. Since any of the clamping portions 206 are connected to the connecting portion 207, all of them are not inserted into the nostril h. In this case, the pair of holding portions 206 are connected by the connecting portion 207 with the nose column j interposed therebetween. As a result, the nasal cavity indwelling device does not go too far into the nasal cavity b and cannot be pulled out. Alternatively, the other holding part 206 may be arranged outside the nose wing k, and the pair of holding parts 206 may be connected by the connecting part 207 with the nose wing k interposed therebetween.
1A、1B、2A、2B、2C…鼻腔留置デバイス
10A、10B、11A、11B、11C…挿入体
110…薄板状部
110a…シート状部材
110b…連結部
101…薬剤類保持部
102…接触表面
103…近位端
104…遠位端
105…近位端開口
106…遠位端開口
20A、20B、20C、20D、20E、20F…鼻腔装着体
201、201a…バネ状部材
202、202a…支持部
203a、203b、203c…係止部
204…スプリング
205…錐体部
205a…開口
206…挟持部
207…連結部
a…副鼻腔、b…鼻腔、c…キーゼルバッハ部位、d…中鼻甲介、e…下鼻甲介、f…下
鼻道、g…上唇、h…鼻孔、i…咽頭、j…鼻柱、k…鼻翼、l…鼻尖部
1A, 1B, 2A, 2B, 2C ... nasal cavity placement devices 10A, 10B, 11A, 11B, 11C ... Insert 110 ... Thin plate portion 110a ... Sheet-like member 110b ... Connection portion 101 ... Drug holding portion 102 ... Contact surface 103 ... Proximal end 104 ... Distal end 105 ... Proximal end opening 106 ... Distal end opening 20A, 20B, 20C, 20D, 20E, 20F ... Nasal cavity mounting body 201, 201a ... Spring- like member 202, 202a ... Support part 203a , 203b, 203c ... locking part 204 ... spring 205 ... cone part 205a ... opening 206 ... clamping part 207 ... connecting part a ... sinuses, b ... nasal cavity, c ... kieselbach region, d ... middle turbinate, e ... bottom Nasal concha, f ... lower nasal passage, g ... upper lip, h ... nostril, i ... pharynx, j ... nasal column, k ... nasal wing, l ... nasal tip

Claims (18)

  1.  長手方向に近位端と遠位端とを有する挿入体を備え、該挿入体を鼻腔に留置させるための鼻腔留置デバイスであって、
     前記挿入体は、薬剤類を保持可能な薬剤類保持部を備え、
     前記薬剤類保持部の少なくとも一部は、前記挿入体の近位端と遠位端との間の表面に露出しており、留置時に前記表面と鼻腔粘膜とが接触するように構成されている、鼻腔留置デバイス。
    A nasal indwelling device comprising an insert having a longitudinally proximal end and a distal end, for placing the insert in the nasal cavity,
    The insert includes a drug holding unit capable of holding drugs,
    At least a part of the medicine holding part is exposed on the surface between the proximal end and the distal end of the insert, and is configured such that the surface and the nasal mucosa come into contact when placed. Nasal placement device.
  2.  前記挿入体を鼻腔に装着させるための鼻腔装着体をさらに有し、
     前記鼻腔装着体は、前記挿入体の近位端に連結されている、請求項1に記載の鼻腔留置デバイス。
    A nasal cavity mounting body for mounting the insert body on the nasal cavity;
    The nasal cavity placement device according to claim 1, wherein the nasal cavity mounting body is connected to a proximal end of the insert.
  3.  前記挿入体は、断面が環状のチューブである、請求項2に記載の鼻腔留置デバイス。 The nasal cavity placement device according to claim 2, wherein the insert is a tube having an annular cross section.
  4.  前記鼻腔装着体と前記挿入体の近位端との間に開口が画成されている、請求項3に記載の鼻腔留置デバイス。 The nasal cavity placement device according to claim 3, wherein an opening is defined between the nasal cavity wearing body and a proximal end of the insertion body.
  5.  前記鼻腔装着体は、前記挿入体に向かって延出して前記挿入体の近位端に連結する支持部を備え、
     前記支持部は前記挿入体よりも剛性が大きい、請求項4に記載の鼻腔留置デバイス。
    The nasal cavity mounting body includes a support portion that extends toward the insertion body and connects to the proximal end of the insertion body,
    The nasal cavity indwelling device according to claim 4, wherein the support portion has higher rigidity than the insertion body.
  6.  前記挿入体は、断面がU字状のチューブである、請求項1又は2に記載の鼻腔留置デバイス。 The nasal cavity placement device according to claim 1 or 2, wherein the insert is a tube having a U-shaped cross section.
  7.  前記挿入体は、前記薬剤類保持部が設けられた薄板状部を備え、
     前記薄板状部は、前記鼻腔装着体よりも短手方向の長さが大きい、請求項2に記載の鼻腔留置デバイス。
    The insert includes a thin plate-like part provided with the medicine holding part,
    The nasal cavity indwelling device according to claim 2, wherein the thin plate-like portion is longer in the short direction than the nasal cavity wearing body.
  8.  前記薄板状部は、弾性変形可能である、請求項7に記載の鼻腔留置デバイス。 The nasal cavity placement device according to claim 7, wherein the thin plate portion is elastically deformable.
  9.  前記薄板状部は、複数のシート状部材が互い連結して構成されている、請求項7又は8に記載の鼻腔留置デバイス。 The nasal cavity placement device according to claim 7 or 8, wherein the thin plate-like portion is configured by connecting a plurality of sheet-like members to each other.
  10.  前記薄板状部の断面は、前記薬剤類保持部が露出する前記表面側に向かって薄手になる形状である、請求項7~9のいずれか一項に記載の鼻腔留置デバイス。 The nasal cavity indwelling device according to any one of claims 7 to 9, wherein a cross section of the thin plate-like portion has a shape that becomes thinner toward the surface side where the medicine holding portion is exposed.
  11.  前記薄板状部の短手方向の長さは、前記遠位端に沿って小さくなる、請求項7~10のいずれか一項に記載の鼻腔留置デバイス。 The nasal cavity placement device according to any one of claims 7 to 10, wherein a length of the thin plate portion in a short direction is reduced along the distal end.
  12.  前記鼻腔装着体は、前記挿入体の近位端に連結して、前記挿入体に挿管される支持部を備え、
     前記支持部は、前記挿入体よりも剛性が大きい、請求項7~11のいずれか一項に記載の鼻腔留置デバイス。
    The nasal cavity mounting body includes a support portion that is connected to the proximal end of the insert and is intubated by the insert.
    The nasal cavity indwelling device according to any one of claims 7 to 11, wherein the support portion has higher rigidity than the insert.
  13.  前記鼻腔装着体は、互いに対向する一対の挟持部と、該一対の挟持部を連結する弾性変形可能な連結部とを備える、請求項2~12のいずれか一項に記載の鼻腔留置デバイス。 The nasal cavity placement device according to any one of claims 2 to 12, wherein the nasal cavity wearing body includes a pair of holding parts facing each other and an elastically deformable connecting part that connects the pair of holding parts.
  14.  前記鼻腔装着体は、円形状の外周を有する係止部を備え、
     前記係止部は、前記挿入体の留置時に鼻前庭に係止される、請求項2~12のいずれか一項に記載の鼻腔留置デバイス。
    The nasal cavity wearing body includes a locking portion having a circular outer periphery,
    The nasal cavity placement device according to any one of claims 2 to 12, wherein the locking portion is locked to the nasal vestibule when the insert is placed.
  15.  前記鼻腔装着体は、断面がC字状のバネ状部材である、請求項2~12のいずれか一項に記載の鼻腔留置デバイス。 The nasal cavity placement device according to any one of claims 2 to 12, wherein the nasal cavity wearing body is a spring-like member having a C-shaped cross section.
  16.  前記鼻腔粘膜は、少なくともキーゼルバッハ部位を含む、請求項1~15のいずれか一項に記載の鼻腔留置デバイス。 The nasal cavity placement device according to any one of claims 1 to 15, wherein the nasal mucosa includes at least a kieselbach region.
  17.  前記薬剤類保持部は、多孔性構造を有する、請求項1~16のいずれか一項に記載の鼻腔留置デバイス。 The nasal cavity indwelling device according to any one of claims 1 to 16, wherein the medicine holding part has a porous structure.
  18.  前記薬剤類保持部は、マトリクス構造を有する、請求項1~17のいずれか一項に記載の鼻腔留置デバイス。 The nasal cavity indwelling device according to any one of claims 1 to 17, wherein the medicine holding unit has a matrix structure.
PCT/JP2016/066916 2015-06-15 2016-06-07 Nostril indwelling device WO2016204026A1 (en)

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