JP2018064792A - Trachea tube - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a trachea tube capable of improving working property of aspiration of phlegm by a suction catheter.SOLUTION: A trachea tube 101 comprises: a tip end part 112 arranged on a lung side in a trachea; a base end part 121; and a lumen body 102 having a lumen for airway maintenance which penetrates from the base end part to the tip end part. At least a part of the lumen body is formed of a moisture content permeable resin material p, and on a part of an inner peripheral surface of the lumen body, a hydrophilic coating 150 is formed. The portion formed of the moisture content permeable resin material can transmit a moisture content in a body fluid contacting with an outer surface of the lumen body to an inner surface side of the lumen body in a detention portion of the lumen body. The hydrophilic coating can hold a water layer on its surface, by at least one selected from a moisture content in respiratory air which passes through the lumen body, moisture content included in phlegm which passes through the lumen body, and moisture content which transmitted to the inner surface side of the lumen body, in a non-immersion state.SELECTED DRAWING: Figure 2A

Description

  The present invention relates to tracheal tubes such as tracheostomy tubes and endotracheal tubes.

  As a method for securing the airway of a patient who needs to secure the airway, tracheal intubation, which is a method of inserting a tracheal tube called an endotracheal tube into the trachea from the mouth or nose through the pharynx to the trachea, Tracheostomy (surgical trachea) is a method in which tracheostomy tubes called tracheostomy tubes are inserted into the trachea from the incision through the skin of the trachea and the upper part of the trachea when the intubation is prolonged or when tracheal intubation is impossible Incision) If the airway is urgently needed, annular thyroid incision is a method of inserting the tracheal cannula by incising the annular thyroid (annular thyroid ligament), and inserting the tracheal cannula by puncturing the annular thyroid An example is a ring-shaped thyroid puncture.

  Tracheal tubes used in these various methods (hereinafter collectively referred to as tracheal tubes) are used in the operating room, ICU ward, medical ward, etc., for the purpose of respiratory management and airway securing (vaginal suction). Medical equipment.

  However, since the trachea is stimulated by inserting the tracheal tube into the trachea, the amount of sputum and other secretions increases, causing constriction / occlusion of the tracheal tube and causing dyspnea / suffocation There is a fear. Although wrinkles are normally discharged by ciliary movement of the trachea, wrinkles are likely to adhere because the tracheal tube has no cilia. Therefore, the sputum in the tracheal tube must be periodically sucked to prevent the tracheal tube from becoming constricted and not blocked. The salmon is mainly composed of water and glycoprotein (mucin), and its viscosity is as wide as several hundred to several hundreds of thousands cP. The higher the viscosity, the easier it will adhere to the tracheal tube. Residue is likely to appear. The soot left behind in the tracheal tube may dry out and become more likely to adhere. The burden on the nurse / caregiver is large because the suction must be carefully conducted so as to reduce as much as possible. If the wrinkles that could not be removed adhere to the inner surface of the tube and become blocked, it is necessary to replace the tracheal tube, which places a burden on the patient's body. Therefore, a method for reducing the sticking of soot to the inner surface of the tracheal tube is desired.

  For example, Patent Document 1 discloses that a coating film, which is composed of a mixture of a methyl vinyl ether maleic anhydride copolymer and a fluorine-containing / acrylic / urethane / silicone resin, that exhibits surface lubricity when wet is formed on the inner surface of the tube. Describes a tracheostomy tube that can be inserted into a trachea in which foreign objects such as sputum are less likely to accumulate.

International Publication No. 2006/037626

M. Tanaka; A. Mochizuki, Effect of water structure on blood compatibility-thermal analysis of water in poly (meth) acrylate, J. Biomed. Mat. Res. Part A 68A (4), 684-695 (2004)

The inventors of the present invention have found that the tracheal tube described in Patent Document 1 may have insufficient suppression of soot adhesion.
Accordingly, an object of the present invention is to provide a tracheal tube to which soot is difficult to adhere.

  As a result of intensive studies by the present inventors, it has been found that the above object can be achieved by adopting the following configuration.

A distal end portion disposed on the lung side in the trachea, a proximal end portion provided on the opposite side of the distal end portion, and a lumen body having an airway securing lumen penetrating from the proximal end portion to the distal end portion. A tracheal tube,
At least a part of the lumen body is made of a water-permeable resin material,
A hydrophilic film is formed on at least a part of the inner peripheral surface of the lumen body,
The part of the luminal body made of the water-permeable resin material is permeable to the water in the body fluid that comes into contact with the outer surface of the luminal body in the indwelling part of the luminal body. Can be
In the non-immersed state, the hydrophilic film includes moisture in the respiratory air that passes through the lumen body, moisture contained in the sputum that passes through the lumen body, and moisture that has permeated the inner surface side of the lumen body. A tracheal tube characterized in that an aqueous layer can be retained on the surface by at least one selected from the group consisting of:

  ADVANTAGE OF THE INVENTION According to this invention, the tube for tracheas to which a wrinkle cannot adhere easily can be provided.

It is a figure which shows the state which mounted | wore the patient with the tracheostomy tube. It is sectional drawing which shows the principal part of a tracheotomy tube. It is the sectional view on the AA line of FIG. It is the BB sectional view taken on the line of FIG. It is sectional drawing which shows the state which attracts | sucks the wrinkles adhering to the inside of a tracheotomy tube. 2 is a cross-sectional view schematically showing an example of a water layer held on the surface of a hydrophilic film A. FIG. 5 is a cross-sectional view schematically showing another example of a water layer held on the surface of the hydrophilic film A. FIG. 2 is a cross-sectional view schematically showing an example of a water layer held on the surface of a hydrophilic film B. FIG. 4 is a cross-sectional view schematically showing another example of an aqueous layer held on the surface of the hydrophilic film B. FIG.

[Definition of terms]
“Wrinkle” is a type of mucus that is a viscous fluid that is secreted from mucous membranes such as the trachea and has a slimy nature. It has a property of pulling a thread) and viscoelasticity (a property of rubber, such that it stretches when it is grabbed and lifted, returns to its original shape when released, and breaks when stretched more than a certain amount). Examples of the main components of koji include water and glycoproteins such as mucin.

[Tracheal tube]
First, the tracheal tube will be described with reference to FIGS. 1 and 2A to 2D. The tracheal tube shown in FIGS. 1 and 2A to 2D is a so-called tracheostomy tube.
A tracheostomy tube 101 shown in FIG. 1 is an instrument for performing respiratory management of a patient, and is used in a state where it is directly inserted into the trachea 7 through an incision hole formed by incising the trachea. The tracheostomy tube 101 includes a lumen body 102 constituting a main part of the tracheostomy tube 101, and a fixing portion 127 for fixing the lumen body 102 to a patient.
As shown in FIGS. 2A and 2B, a specific hydrophilic film 150 is disposed on the inner surface (inner peripheral surface) forming the lumen 102 a for securing the airway of the lumen body 102.
Hereinafter, each member constituting the tracheostomy tube 101 will be described.

The lumen body 102 is formed in a cylindrical shape that is open at both ends and has a uniform outer diameter and inner diameter along the length direction. Inside the lumen body 102, an airway securing lumen 102a that is a space through which exhalation passes along the length direction of the lumen body 102 is formed.
The lumen body 102 includes a distal end portion 122, a proximal end portion 121 disposed on the opposite side of the distal end portion 122, and a curved portion 123 positioned between the proximal end portion 121 and the distal end portion 122. The curved portion 123 is curved so that the central axis of the distal end portion 122 and the central axis of the proximal end portion 121 intersect at an angle θ. In FIG. 2A, the lumen body 102 is formed in a substantially L shape. That is, the angle θ is about 90 °.
The lumen body 102 has such flexibility that the θ can be changed in a range from about 90 ° to about 120 ° in accordance with a change in the posture of the patient. Even if the θ changes within this range, the hydrophilic film 150 does not peel off or fall off from the lumen body 102.

  As shown in FIG. 2A, from a tracheostomy hole formed by incising the tube wall of the trachea 7 and the skin 5 on the upper part of the trachea 7 with respect to a patient lying on his / her back (the supine position), The distal end portion 122 of the lumen body 102 is inserted into the trachea 7. At this time, the distal end portion 122 of the luminal body 102 is tracheal toward the lung side so as to be spaced apart from the mucous membranes (skin-side tracheal mucosa 7a, inner tracheal mucosa 7b) constituting the tube wall of the trachea 7. 7.

  Further, the proximal end portion 121 of the lumen body 102 is exposed to the outside from the tracheostomy hole, and a ventilator (not shown) is attached to the proximal end portion 121. By operating the ventilator, exhaled air and inhaled air (breathing air) pass through the airway securing lumen 102a. Thereby, the patient's breathing is sustained and respiratory management is performed. As a result, it is possible to prevent the airway, which is a passage for oxygen necessary for breathing, from being blocked, and to manage the patient's breathing.

The fixing portion 127 is attached to the proximal end portion 121 of the lumen body 102. The fixing portion 127 fixes the distal end portion 122 to an appropriate position in the trachea 7 by contacting the skin 5 when the luminal body 102 is attached to the patient. 129.
The fixed plate 128 is a flat plate member, and a storage hole 131 that penetrates the fixed plate 128 is formed at the center. An adhesive portion 129 is attached to the front surface of the fixing plate 128, and the back surface of the fixing plate 128 is brought into contact with the patient's skin 5.
The bonding portion 129 is for bonding the lumen body 102 to the fixing portion 127, and has a ring shape in which a substantially circular through hole 130 is formed at the center. The through hole 130 of the bonding portion 129 communicates with the storage hole 131 of the fixing plate 128, and the size of the through hole 130 is set according to the outer diameter of the lumen body 102.
The lumen body 102 passes through the accommodation hole 131 of the fixing plate 128 and the through hole 130 of the bonding portion 129, and is fixed by, for example, an adhesive.

The case where the wrinkles in the tracheostomy tube 101 are removed using a suction catheter will be described with reference to FIG. 2D.
As shown in FIG. 1, since a patient wearing the tracheostomy tube 101 usually has his head raised and lies on his back, foreign objects such as a heel tend to accumulate on the back side in the direction of gravity. That is, wrinkles easily collect on the lower side in FIG. 2D.
Therefore, the suction catheter 601 is inserted into the lumen body 102 from the proximal end 121 side of the lumen body 102, and the tip of the suction catheter 601 is advanced to the vicinity of the tip section 122 along the inner surface of the lumen body 102, The soot Z can be removed by suction.
Further, by removing or inserting the suction catheter 601 in the vicinity of the distal end portion 122 or rotating it, the sputum Z is removed by being pushed out at the distal end of the suction catheter 601 or attached to the outside of the suction catheter 601. You can also

In the medical tube of the present invention, at least a part of the lumen 102 is made of a water-permeable resin material. In FIG. 2A and FIG. 2C, the site | part shown with the code | symbol p among the lumen bodies 102 is comprised with the water-permeable resin material. In the part indicated by the symbol p, all parts from the outer surface of the lumen body 102 in contact with the subcutaneous tissue 6 to the inner surface forming the airway securing lumen 102a of the lumen body 102 are made of a water-permeable resin material. ing.
As shown to FIG. 2A and FIG. 2B, you may comprise by the resin material other than the site | part shown with the code | symbol p among the lumen bodies 102. FIG. Examples of other resin materials include synthetic resins such as silicone, polycarbonate, polypropylene, polyethylene, and polyvinyl chloride.
All the parts other than the part shown by the code | symbol p may be comprised with the moisture-permeable resin material.

  Examples of the moisture permeable resin material constituting the lumen body 102 include a porous resin material such as Gore-Tex provided with many fine holes communicating from the outer surface to the inner surface of the lumen body 102. In addition, a synthetic resin such as silicone, polycarbonate, polypropylene, polyethylene, and polyvinyl chloride may be provided with a large number of fine holes communicating from the outer surface to the inner surface of the lumen 102 by laser processing, ion beam processing, or the like. In addition, a highly water-permeable resin material used for applications where moisture permeability is required, such as hard contact lenses and soft contact lenses. Specifically, methyl methacrylate (MMA), siloxanyl methacrylate (SMA), fluoromethacrylate (FMA), hydroxyethyl methacrylate (HEMA), N-vinylpyrrolidone (N-VP), dimethylacrylamide (DMAA), glycerol methacrylate (GMA), silicon rubber, butyl acrylate, dimethylsiloxane, collagen, amino acid copolymer, silicon-containing methacrylate (SIMA), fluorine-containing methacrylate (FMA), poly-2-hydroxyethyl methacrylate (P-HEMA), silicone hydrogel (TRIS, SIGMA, etc.). These high moisture permeable resin materials may constitute the luminal body 102 as a single layer, or may constitute the luminal body 102 by laminating a plurality of high moisture permeable resin materials. In the case where a plurality of layers are laminated, it is preferable that the material constituting the inner surface side layer of the lumen body 102 has higher moisture permeability than the material constituting the outer surface side layer of the lumen body 102.

  In the lumen body 102, the portion indicated by the symbol p is made of a water-permeable resin material, so that moisture in the body fluid that comes into contact with the outer surface of the lumen body 102 at the indwelling portion of the lumen body 102. , And can be transmitted through the inner surface side of the lumen body 102. In the case of FIG. 2A, a body fluid existing in the subcutaneous tissue 6 that comes into contact with the luminal body, specifically, blood, lymph fluid, or the like can be transmitted to the inner surface side of the luminal body 102.

  A hydrophilic film 150 is disposed on at least a part of the inner peripheral surface of the lumen body 102. Of the inner peripheral surface of the luminal body 102, it is preferable that the hydrophilic film 150 is disposed on the portion indicated by the symbol p, and the hydrophilic film 150 is disposed on the entire inner peripheral surface of the luminal body 102. It is more preferable.

[Hydrophilic film]
The hydrophilic film disposed on at least a part of the inner peripheral surface of the lumen body of the tracheal tube retains an aqueous layer on the surface by moisture permeated to the inner surface side of the lumen body in a non-immersed state. Can do.
Here, the “non-immersed state” means that the corresponding surface of the medical device, that is, the inner surface of the lumen for securing the airway of the tracheal tube in the present invention is not in contact with the liquid (aqueous solvent, body fluid, secretion fluid, etc.), or A state in which at least a part does not contact. This state is an immersion state, in which the corresponding surface of the medical device is in contact with a liquid (aqueous solvent, body fluid, secretion fluid, etc.), specifically, the inner surface of the lumen for securing the airway is immersed or in contact with body fluid or blood The luminal surface is not in contact with the liquid, but the respiratory moisture passing through the luminal body, the moisture contained in the sputum passing through the luminal body, and the luminal body The state which can form a water layer on a hydrophilic membrane | film | coat by contacting with at least one selected from the group which consists of the water | moisture content permeate | transmitted to the inner surface side of.
Examples of the hydrophilic film satisfying the above include hydrophilic film A and hydrophilic film B described later. In the following, first, the hydrophilic film A is described in detail, and then the hydrophilic film B is described in detail.

<Hydrophilic film A>
The hydrophilic film A is a hydrophilic film containing at least a copolymer A described below.
The content of the copolymer A in the hydrophilic film A is, for example, 50% by mass or more, preferably 70% by mass or more, more preferably 85% by mass or more, still more preferably 95% by mass or more, and 98% by mass or more. Is particularly preferred.

<Copolymer A>
The copolymer A has a repeating unit (A) represented by the following formula (1) and a repeating unit (B) represented by the following formula (2), and the repeating unit (A) for all repeating units. Is a copolymer having a content of 0.6 to 7 mol%.

However, in Formula (1), R < ¹¹ > is a hydrogen atom or a methyl group, Z is an oxygen atom or -NH-, R < ¹² > is a C1-C6 alkylene group, R <^13> and R ¹⁴ is independently an alkyl group having 1 to 4 carbon atoms, and R ¹⁵ is an alkylene group having 1 to 6 carbon atoms.
In Formula (2), R ²¹ is a hydrogen atom or a methyl group, R ²² is an alkylene group having 1 to 6 carbon atoms, and R ²³ is an alkyl group having 1 to 4 carbon atoms.

  The terminal of the copolymer A is not particularly limited and is appropriately defined depending on the type of raw material used, but is usually a hydrogen atom. Copolymer A may be any of a random copolymer, an alternating copolymer, a periodic copolymer, and a block copolymer.

The weight average molecular weight of the copolymer A is preferably 1,000 to 1,000,000, more preferably 50,000 to 500,000.
In addition, the value measured by the gel permeation chromatography (Gel Permeation Chromatography, GPC) using polystyrene as a standard substance and tetrahydrofuran (THF) as a mobile phase shall be employ | adopted for "weight average molecular weight."

  Hereinafter, each structural unit (repeating unit) of the copolymer A will be described.

(Repeating unit (A))
The copolymer A essentially contains the repeating unit (A) represented by the above formula (1).

In the above formula (1), R ¹¹ is a hydrogen atom or a methyl group, a methyl group is preferable.

  In said formula (1), Z is an oxygen atom or -NH-. From the viewpoint of durability, Z is preferably —NH—. When Z is —NH—, an amide structure is formed in the above formula (1). Therefore, it is excellent in hydrolysis resistance compared with the case where Z is an oxygen atom (that is, the case where the ester structure in the above formula (1) is formed), and is suitable for use in contact with biological components for a long period of time.

In said formula (1), R < ¹² > is a C1-C6 linear or branched alkylene group, Specifically, a methylene group, ethylene group, trimethylene group, propylene group, tetramethylene group, A pentamethylene group, a hexamethylene group, etc. are mentioned. Among these, a linear or branched alkylene group having 1 to 4 carbon atoms is preferable, a methylene group, an ethylene group, or a trimethylene group is more preferable, and an ethylene group or a trimethylene group is further preferable.

In the above formula (1), R ¹³ and R ¹⁴ are each independently an alkyl group having 1 to 4 carbon atoms, specifically, methyl group, ethyl group, propyl group, isopropyl group, butyl group, Examples thereof include a linear or branched alkyl group of an isobutyl group, a sec-butyl group, and a tert-butyl group. Of these, a linear or branched alkyl group having 1 to 3 carbon atoms is preferable, an alkyl group having 1 or 2 carbon atoms (methyl group, ethyl group) is more preferable, and a methyl group is preferable. And more preferred.

In the above formula (1), R ¹⁵ is a linear or branched alkylene group having 1 to 6 carbon atoms, and specific examples thereof include the same groups as those described in the description of R ¹² above. . Among these, a linear or branched alkylene group having 1 to 4 carbon atoms is preferable, a methylene group, an ethylene group, or a trimethylene group is more preferable, and a trimethylene group is further preferable.

Thus, the repeating units (A), in the above formula (1), R ¹¹ is a methyl group, Z is an oxygen atom or -NH-, R ¹² is an alkylene group having 1 to 4 carbon atoms , R ¹³ and R ¹⁴ are each independently an alkyl group having 1 or 2 carbon atoms, and R ¹⁵ is preferably an alkylene group having 1 to 4 carbon atoms. In the above formula (1), R ¹¹ is a methyl group, R ¹² is an alkylene group having 2 or 3 carbon atoms, Z is an oxygen atom or —NH—, and R ¹³ and R ¹⁴ are carbon atoms. More preferably, it is an alkyl group having 1 atom (methyl group), and R ¹⁵ is an alkylene group having 3 carbon atoms.

  The copolymer A includes a monomer (hereinafter also referred to as “monomer a”) that forms the repeating unit (A) and a monomer (hereinafter referred to as “monomer b”) that forms the repeating unit (B) described in detail below. Also referred to as a polymerization reaction).

  As the monomer a, for example, when Z is an oxygen atom or when Z is -NH-, the following compounds can be used. The following monomers may be used alone or in combination of two or more. Moreover, you may mix and use the compound whose Z is an oxygen atom, and the compound whose Z is -NH-.

  When Z is an oxygen atom, examples of the monomer a include [2- (methacryloyloxy) ethyl] dimethyl- (3-sulfopropyl) ammonium hydroxide, [2- (acryloyloxy) ethyl] dimethyl- (3- Sulfopropyl) ammonium hydroxide, {2-[(meth) acryloyloxy] ethyl} dimethyl- (2-sulfoethyl) ammonium hydroxide, {2-[(meth) acryloyloxy] ethyl} diethyl- (2-sulfoethyl) ammonium Hydroxide, {2-[(meth) acryloyloxy] ethyl} diethyl- (3-sulfopropyl) ammonium hydroxide, {3-[(meth) acryloyloxy] propyl} dimethyl- (2-sulfoethyl) ammonium hydroxide, {3-[(meta) a Liloyloxy] propyl} dimethyl- (3-sulfopropyl) ammonium hydroxide, {3-[(meth) acryloyloxy] propyl} diethyl- (2-sulfoethyl) ammonium hydroxide, {3-[(meth) acryloyloxy] propyl } Diethyl- (3-sulfopropyl) ammonium hydroxide and the like can be mentioned, and [2- (methacryloyloxy) ethyl] dimethyl- (3-sulfopropyl) ammonium hydroxide is preferable.

  When Z is —NH—, examples of the monomer a include [3- (methacryloylamino) propyl] dimethyl (3-sulfopropyl) ammonium hydroxide, [3- (acryloylamino) propyl] dimethyl (3 -Sulfopropyl) ammonium hydroxide, {2-[(meth) acryloylamino] ethyl} dimethyl (2-sulfoethyl) ammonium hydroxide, {2-[(meth) acryloylamino] ethyl} dimethyl (3-sulfopropyl) ammonium Hydroxide, {2-[(meth) acryloylamino] ethyl} diethyl (2-sulfoethyl) ammonium hydroxide, {2-[(meth) acryloylamino] ethyl} diethyl (3-sulfopropyl) ammonium hydroxide, {3 -[(Meta) Ac Roylamino] propyl} dimethyl (2-sulfoethyl) ammonium hydroxide, {3-[(meth) acryloylamino] propyl} diethyl (2-sulfoethyl) ammonium hydroxide, {3-[(meth) acryloylamino] propyl} diethyl ( Examples thereof include [3-sulfopropyl) ammonium hydroxide, and [3- (methacryloylamino) propyl] dimethyl (3-sulfopropyl) ammonium hydroxide is preferable.

  In the present specification, “(meth) acryl” means “acryl” and / or “methacryl”, and “(meth) acryloyl” means “acryloyl” and / or “methacryloyl”. "(Meth) acrylate" means "acrylate" and / or "methacrylate".

(Repeating unit (B))
The copolymer A essentially contains the repeating unit (B) represented by the above formula (2).

In the formula (2), R ²¹ is a hydrogen atom or a methyl group, a hydrogen atom is preferable.

In the above formula (2), R ²² is a linear or branched alkylene group having 1 to 6 carbon atoms, specifically, a methylene group, an ethylene group, a trimethylene group, a propylene group, a tetramethylene group, A pentamethylene group, a hexamethylene group, etc. are mentioned. Of these, a linear or branched alkylene group having 1 to 3 carbon atoms is preferable, a methylene group or an ethylene group is more preferable, and an ethylene group is still more preferable.

In the above formula (2), R ²³ is a linear or branched alkyl group having 1 to 4 carbon atoms, specifically, methyl group, ethyl group, propyl group, isopropyl group, butyl group, isobutyl. And a linear or branched alkyl group of a group, sec-butyl group, and tert-butyl group. Of these, a linear or branched alkyl group having 1 to 3 carbon atoms is preferable, an alkyl group having 1 or 2 carbon atoms (methyl group, ethyl group) is more preferable, and a methyl group is preferable. And more preferred.

From the above, in the repeating unit (B), in the above formula (2), R ²¹ is a hydrogen atom or a methyl group, R ²² is an alkylene group having 1 to 3 carbon atoms, and R ²³ is carbon. An alkyl group having 1 or 2 atoms is preferable. In the above formula (2), R ²¹ is a hydrogen atom or a methyl group, R ²² is an alkylene group having 2 carbon atoms (ethylene group), and R ²³ is an alkyl group having 1 carbon atom. (Methyl group) is more preferable.

  Examples of the monomer b constituting the repeating unit (B) include methoxymethyl (meth) acrylate, methoxyethyl (meth) acrylate, methoxypropyl (meth) acrylate, methoxybutyl (meth) acrylate, (meth ) Ethoxymethyl acrylate, ethoxyethyl (meth) acrylate, ethoxypropyl (meth) acrylate, ethoxybutyl (meth) acrylate, propoxymethyl (meth) acrylate, propoxyethyl (meth) acrylate, (meth) acrylic Examples include propoxypropyl acid, propoxybutyl (meth) acrylate, butoxymethyl (meth) acrylate, butoxyethyl (meth) acrylate, butoxypropyl (meth) acrylate, butoxybutyl (meth) acrylate, and the like.

The monomer b is preferably methoxymethyl (meth) acrylate, methoxyethyl (meth) acrylate, ethoxymethyl (meth) acrylate, ethoxyethyl (meth) acrylate, and is easily available. More preferably, it is methoxyethyl acrylate (MEA).
The said monomer may be used individually by 1 type or in mixture of 2 or more types.

(Content of each repeating unit)
Copolymer A contains 0.6 to 7 mol% of repeating units (A) in all the structural units (100 mol%) of copolymer A. The repeating unit (A) is preferably 0.8 to 6 mol%, more preferably 0.9 to 4.7 mol%, and further preferably 1 to 4 mol% in all the structural units.

  In all the structural units of the copolymer A, the repeating unit (B) is preferably contained, for example, at 60 mol% or more, more preferably 80 mol% or more, and 90 mol% or more. More preferably, it is particularly preferably contained in an amount of 93 mol% or more. On the other hand, the upper limit is 99.4 mol% from the relationship with the repeating unit (A).

  The copolymer A may contain structural units other than the repeating units (A) and (B), but is preferably composed of only the repeating units (A) and (B). That is, in the copolymer A, the total amount of the repeating unit (A) and the repeating unit (B) is preferably 100 mol%.

As the content (ratio) of each repeating unit in the copolymer A, a value determined by the NMR method is adopted (the same applies to the polymer B described later).
For example, in the case of the copolymer A composed of the repeating unit (A) and the repeating unit (B), an alkylene group on the nitrogen atom which is a characteristic structure in each of the repeating units (A) and (B) (That is, R ¹⁵ ) and the ¹ H-NMR integrated value of the alkoxy group (ie, —OR ²³ ) are obtained, and the repeating unit (A) in the copolymer A is repeated based on the ratio of the integrated value. The ratio with the unit (B) can be analyzed. Moreover, in the measurement of ¹ H-NMR, when the peaks overlap, it can be calculated using ¹³ C-NMR.

(Other repeat units)
As described above, the copolymer A preferably comprises only the repeating units (A) and (B), but may contain other repeating units. That is, the copolymer A includes structural units (repeating units) derived from the monomer a, the monomer b, and other monomers copolymerizable therewith (hereinafter also simply referred to as “other monomers”). May be.

  Examples of other monomers copolymerizable with the monomer a and the monomer b include (meth) acrylamide, N, N-dimethyl (meth) acrylamide, N, N-diethyl (meth) acrylamide, aminomethyl (meth) acrylate, Aminoethyl (meth) acrylate, aminoisopropyl (meth) acrylate, diaminomethyl (meth) acrylate, diaminoethyl (meth) acrylate, diaminobutyl (meth) acrylate, methyl (meth) acrylate, ethyl (meth) acrylate, isopropyl (meth) ) Acrylate, butyl (meth) acrylate, 2-ethylhexyl (meth) acrylate, hexyl (meth) acrylate, ethylene, propylene, N-vinylacetamide, N-isopropenylacetamide, N- (meta There is acryloyl morpholine.

  The ratio of the repeating unit derived from the other monomer is not particularly limited in the total structural unit of the copolymer A, but is, for example, more than 0 mol% and less than 39 mol%, preferably more than 0 mol%. It is less than 33 mol%, more preferably more than 0 mol% and less than 9 mol%, and particularly preferably more than 0 mol% and less than 3 mol%.

(Method for producing copolymer A)
The ratio of the repeating unit derived from the repeating unit (A), the repeating unit (B), or other monomer in the copolymer A can be arbitrarily adjusted by changing the ratio of the monomer used in the polymerization. More specifically, the monomer a for constituting the repeating unit (A) may be added at a ratio of 0.6 to 7 mol% with respect to the total number of moles of all monomers used in the polymerization. Further, at this time, it is preferable to add the monomer b for constituting the repeating unit (B) at a ratio of 99.4 to 93 mol% with respect to the total number of moles of all monomers used. Basically, when the molecular weight fractionation or the like is not performed for the copolymer A obtained by copolymerization of the monomer a, the monomer b, and other monomer optionally added, the monomer used for the copolymerization is charged. The ratio is the content of each repeating unit in the copolymer A to be obtained.

The production method of the copolymer A is not particularly limited. For example, known polymerization methods such as radical polymerization, anionic polymerization, and cationic polymerization can be employed, and radical polymerization that is easy to produce is preferably used.
In addition, as a method for producing the copolymer A, plasma polymerization using radiation or ultraviolet rays is employed, and the hydrophilic film A containing the copolymer A is used to form a lumen for securing the airway of the lumen of the tracheal tube. It may be formed on the surface.

  The monomer polymerization method usually requires one or more monomers a corresponding to the repeating unit (A) and one or more monomers b corresponding to the repeating unit (B). For example, a method is used in which other monomers are copolymerized by stirring and heating together with a polymerization initiator in a polymerization solvent.

  The polymerization temperature is preferably 30 ° C to 100 ° C from the viewpoint of controlling the molecular weight. The polymerization reaction is usually performed for 30 minutes to 24 hours.

  The polymerization solvent is preferably an aqueous solvent such as water; alcohols such as methanol, ethanol, propanol and n-butanol; polyhydric alcohols such as ethylene glycol, diethylene glycol, propylene glycol and dipropylene glycol; more preferably methanol. , Ethanol, or propanol. These may be used alone or in combination of two or more.

  The monomer concentration (solid content concentration) in the polymerization solvent is usually 10 to 90% by mass, preferably 15 to 80% by mass, based on the entire reaction solution. In addition, the monomer concentration with respect to the polymerization solvent is the monomer a, the monomer b, and other monomers copolymerizable with these (hereinafter referred to as “monomer a, monomer b, and optional copolymerized with these”). “Other possible monomers” are also referred to as “polymerization monomers”)).

  The polymerization solvent to which the polymerization monomer is added may be subjected to a degassing treatment before the addition of the polymerization initiator.

For the production of the copolymer A, conventionally known polymerization initiators can be used. For example, 2,2′-azobisisobutyronitrile, 2,2′-azobis (4-methoxy-2,4- Examples thereof include, but are not limited to, azo polymerization initiators such as dimethylvaleronitrile) and 2,2′-azobis (2,4-dimethylvaleronitrile).
The compounding quantity of a polymerization initiator is 0.0001-1 mol with respect to all the monomers (1 mol) used for manufacture of the copolymer A, for example.

  Furthermore, if necessary, a chain transfer agent, a polymerization rate adjusting agent, a surfactant, and other additives may be appropriately used in the polymerization.

The atmosphere in which the polymerization reaction is performed is not particularly limited, and can be performed in an air atmosphere or an inert gas atmosphere such as nitrogen gas or argon gas. Further, during the polymerization reaction, the reaction solution may be stirred.
The copolymer A after polymerization can be purified by a general purification method such as a reprecipitation method, a dialysis method, an ultrafiltration method, or an extraction method.

  The purified copolymer A can be dried by any method such as freeze drying, reduced pressure drying, spray drying, or heat drying. However, from the viewpoint of little influence on the physical properties of the polymer, Vacuum drying is preferred.

<< Formation of hydrophilic film A >>
As a method of forming the hydrophilic film A containing the copolymer A, for example, a polymerization solvent containing a monomer for obtaining the copolymer A is applied to the inner surface of the lumen of the tracheal tube, and plasma is applied. A method of performing polymerization; a method of using coating agent A containing copolymer A; and the like. Among these, from the viewpoint of ease of production, the latter method, that is, a method of obtaining the hydrophilic film A using the coating agent A is preferable.

  When the hydrophilic film A is obtained using the coating agent A, more specifically, the coating agent A containing the copolymer A is applied to the inner surface of the lumen body of the tracheal tube by a known method, and thereafter The hydrophilic film A is formed by drying. The drying temperature is appropriately selected and is, for example, 15 to 50 ° C. The atmosphere during drying is not particularly limited, and examples include an air atmosphere or an inert gas atmosphere such as nitrogen gas or argon gas.

The coating agent A is preferably a coating agent in which the copolymer A is dissolved in a solvent. The solvent used for the coating agent A is not particularly limited as long as it can dissolve the copolymer A. For example, alcohol solvents such as methanol, ethanol, isopropanol, and butanol; water; chloroform, tetrahydrofuran, acetone, dioxane, Examples include non-proton donating organic solvents such as benzene; The above solvents may be used alone or in combination of two or more.
The amount of the copolymer A contained in the coating agent A can be arbitrarily set, and can be used as a solution in which the copolymer A is dissolved up to the saturation amount. -50 mass% is preferable and 0.1-50 mass% is more preferable.
The coating agent A may optionally further contain other components such as a crosslinking agent, a thickener, a preservative, and a pH adjuster.

<< Film thickness of hydrophilic film A >>
The film thickness of the hydrophilic film A may be adjusted as appropriate, and is not particularly limited. For example, the film is formed within a range of 1 to 1000 nm.

<Hydrophilic film B>
The hydrophilic film B is a hydrophilic film formed by crosslinking a polymer B described below.
The content of the polymer B in the hydrophilic film B is, for example, 50% by mass or more, preferably 70% by mass or more, more preferably 85% by mass or more, still more preferably 95% by mass or more, and 98% by mass or more. Particularly preferred.

<< Polymer B >>
The polymer B is a polymer having a site that exhibits lubricity and a site that has crosslinkability. Examples of the mode of the polymer B include modes such as a copolymer or a macromonomer.
The weight average molecular weight of the polymer B is preferably 1,000 to 1,000,000, more preferably 50,000 to 500,000.

Examples of the site exhibiting lubricity include, for example, (meth) acrylamide, (meth) acrylamide derivatives, N, N-dimethylaminoethyl (meth) acrylate, monomers having sugars and phospholipids in the side chain, maleic anhydride The site | part derived from etc. is mentioned, Especially, it is preferable that it is a site | part derived from (meth) acrylamide or a (meth) acrylamide derivative. Examples of the (meth) acrylamide derivative include N, N-dimethyl (meth) acrylamide, N, N-diethyl (meth) acrylamide and the like.
The site having crosslinkability is not particularly limited, and examples thereof include a site having a crosslinkable group that is crosslinked by heat treatment or a catalyst. Specific examples thereof include a site having an epoxy group and a (meth) acryloyl group. And the like. In addition, as a site | part which has an epoxy group, the site | part derived from glycidyl (meth) acrylate is mentioned, The polyglycidyl (meth) acrylate which is a polymer of glycidyl (meth) acrylate is mentioned as the specific example.

When the polymer B is a copolymer having a site exhibiting lubricity and a site having crosslinkability, the molar ratio is preferably 1: 5 to 10, and more preferably 1: 6 to 9.
As the polymer B as such a copolymer, for example, polyglycidyl (meth) acrylate, which is a polymer of glycidyl (meth) acrylate, and (meth) acrylamide or a (meth) acrylamide derivative are polymerized. A copolymer (block copolymer) is mentioned. The polymerization conditions are not particularly limited. For example, the reaction is performed in a solvent such as dimethyl sulfoxide at a temperature of 65 to 85 ° C. for about 15 to 20 hours.

Examples of the polymer B that is a macromonomer include a macromonomer of glycidyl (meth) acrylate and dimethyl (meth) acrylamide; a macro of glycidyl (meth) acrylate and maleic anhydride / hydroxyethyl (meth) acrylate copolymer Monomer; macromonomer of glycidyl (meth) acrylate and maleic anhydride / (meth) acrylamide copolymer; and the like.
The following polymer (2) is mentioned as a specific example of such a macromonomer.
First, 10 g of dimethylacrylamide, 1 g of iodoacetic acid as a chain transfer agent, and 0.05 g of t-butyl peroctoate as an initiator are reacted under reduced pressure at 80 ° C. for 8 hours to obtain a polymer (1). 5 g of the obtained polymer (1) and 1 g of glycidyl methacrylate are dissolved in 90 g of benzene and reacted in a nitrogen atmosphere at 60 ° C. for 8 hours in the presence of a small amount of hydroquinone. The reaction product is purified using diethyl ether as a poor solvent and tetrahydrofuran as a good solvent to obtain a polymer (2).

<< Formation of hydrophilic film B >>
Examples of the method for forming the hydrophilic film B formed by crosslinking the polymer B include a method obtained using a coating agent B containing the polymer B. In this case, more specifically, the coating agent B containing the polymer B is applied to the inner surface of the lumen body of the tracheal tube by a known method, and then the polymer B is crosslinked by heating or the like. To form a hydrophilic film B.
In the case of heating, the heating conditions are not particularly limited. For example, the heating is performed at a temperature of more than 50 ° C. and 80 ° C. or less for about 5 to 20 hours.

The solvent used for the coating agent B is not particularly limited as long as the polymer B can be dissolved, and examples thereof include 1,4-dioxane, tetrahydrofuran, chloroform and the like.
The amount of the polymer B contained in the coating agent B can be arbitrarily set, and is, for example, 0.01 to 50% by mass, preferably 0.1 to 25% by mass, based on the entire coating agent B, 1-10 mass% is more preferable.

In the coating agent B, a known catalyst such as pyridine or azobisisobutyronitrile is preferably selected and blended appropriately depending on the site having crosslinkability.
Although the compounding quantity of a catalyst is not specifically limited, For example, it is the range of 0.001-1 mass part with respect to 1 mass part polymer B, The range of 0.005-0.5 mass part is preferable.

<< Thickness of hydrophilic film B >>
Although the thickness of the hydrophilic film | membrane B is not specifically limited, For example, it forms in the range of 1-1000 nm.

[Water layer retained on hydrophilic film]
Polymers such as PMEA (2-methoxyethyl polyacrylate) take up and retain water. The water retained in the polymer has properties different from, for example, water in a cup (bulk water: freezes at 0 ° C.).
Water (hydration water) in such a polymer is classified into non-freezing water (non-freezing water) and freezing water (freezing water) as a result of differential scanning calorimetry (DSC) measurement. Antifreeze water is water that does not freeze even when cooled to minus 100 ° C. (water that has a strong interaction with the polymer). Freezing water includes water that freezes around 0 ° C (free water: very little interaction with polymer) and water that freezes at minus tens of degrees (intermediate water: water that has moderate interaction with the polymer). There are two types (see Non-Patent Document 1, for example).

  For example, when the process of water adsorption on PMEA is observed by time-resolved infrared spectroscopy (in situ ATR-IR), antifreeze water, intermediate water, and free water are observed at different adsorption times. Specifically, antifreeze water forms hydrogen bonds with carbonyl groups in the early stage of adsorption, intermediate water interacts with side chain terminal methoxy groups in the middle stage of adsorption, and forms a hydrogen bond structure similar to that of bulk water in the late stage of adsorption. It is observed that the free water it has is bound.

<Water layer retained by hydrophilic film A>
As will be described later in Test Example 1, the presence of antifreeze water and intermediate water is confirmed from the hydrophilic film A in a state of contact with respiratory air (see Sample A1a in Test Example 1).
Similarly, the presence of antifreeze water, intermediate water and free water is confirmed from the hydrophilic film A in a state where the simulated sputum is in contact with the breathing air (see sample A1b in Test Example 1).

  The relative quantitative ratios of antifreeze water, intermediate water and free water in the hydrophilic film A are shown in Table 1 below. In Table 1 below, the greater the number of “+”, the greater the amount of water. In addition, “-” in the following Table 1 indicates that water (here, free water) does not exist. In sample A1b, compared with sample A1a, the presence of soot increases the amount of intermediate water and free water.

In this specification, when the presence of at least antifreeze water and intermediate water is confirmed from the hydrophilic film A, it is assumed that an aqueous layer is held on the surface of the hydrophilic film A.
For this reason, in sample A1a, the water layer derived from the water | moisture content in respiratory air is hold | maintained on the surface of the hydrophilic membrane | film | coat A. FIG.
Moreover, in sample A1b, the water layer derived from the water | moisture content in the soot is hold | maintained on the surface of the hydrophilic membrane | film | coat A. FIG. This aqueous layer is also derived from the moisture in the respiratory air.
By holding such an aqueous layer on the surface of the hydrophilic film A, the simulated soot does not adhere to the surface of the hydrophilic film A and the flow of respiratory air, as will be described later in Test Example 1. And can be easily removed by a suction catheter.
Although not shown in Test Example 1 described later, even when the moisture in the body fluid contacts the outer surface of the luminal body at the indwelling site of the luminal body, the moisture remains on the inner surface side of the luminal body. The aqueous layer is retained on the surface of the hydrophilic film A by passing through and contacting the hydrophilic film A.

  From the viewpoint of the strength of interaction with the polymer, the water layer made of antifreeze water is a “strongly fixed layer” relatively strongly fixed to the hydrophilic film A, and the water layer made of intermediate water is relative to the hydrophilic film A. In particular, the “medium fixing layer” fixed to a medium level and the water layer made of free water can be defined as “weak fixing layer” fixed relatively weakly to the hydrophilic film A.

For example, in the sample A1a, as shown in FIG. 3A, the strongly fixed layer W ₁ and the intermediate fixed layer W ₂ are held in this order on the surface of the hydrophilic film A (indicated by reference numeral 150 in FIG. 3A). Yes. In FIG. 3A, the strongly fixed layer W ₁ is held on the smooth surface of the hydrophilic film A denoted by reference numeral 150, and the middle fixed layer W ₂ is held on the strongly fixed layer W ₁ . Aqueous layer on the middle fixed layer W ₂ is absent, the middle fixed layer W ₂ is relatively thicker than the reinforced fixed layer W _1.
In Sample A1b, as shown in FIG. 3B, on the hydrophilic film A (indicated by reference numeral 150 in FIG. 3B), the strong fixed layer W ₁ , the intermediate fixed layer W ₂ and the weak fixed layer W ₃ are They are held in this order. In FIG. 3B, the strong fixed layer W ₁ is held on the smooth surface of the hydrophilic film A denoted by reference numeral 150, the middle fixed layer W ₂ is held on the strong fixed layer W ₁ , A weak fixed layer W ₃ is held on the middle fixed layer W ₂ . There is no water layer on the weak fixed layer W ₃ , the strong fixed layer W ₁ and the weak fixed layer W _{3 have} the same thickness, and the middle fixed layer W ₂ is the strong fixed layer W ₁ and the weak fixed layer W _3. Relatively thicker.
As a result, the strong fixed layer W ₁ is protected by the intermediate fixed layer W ₂ , or the intermediate fixed layer W ₂ and the weak fixed layer W ₃ , and the protected strong fixed layer W ₁ is applied to the surface of the hydrophilic film A. Sputum is prevented from adhering.

<Water layer of hydrophilic film B>
As will be described later in Test Example 2, the presence of antifreeze water and free water is confirmed from the hydrophilic film B in contact with respiratory air (see Sample B1a in Test Example 2).
Similarly, the presence of antifreeze water and free water is confirmed from the hydrophilic film B in a state where the simulated sputum is in contact with the breathing air (see sample B1b of Test Example 1).

  The relative quantitative ratios of antifreeze water, intermediate water and free water in the hydrophilic film B are shown in Table 2 below. In Table 2 below, the greater the number of “+”, the greater the amount of water. In addition, “-” in Table 2 below indicates that water (in this case, intermediate water) does not exist. In sample B1b, free water is increased due to the presence of soot compared to sample B1a.

In this specification, when the presence of at least antifreeze water and free water is confirmed from the hydrophilic film B, an aqueous layer is assumed to be held on the surface of the hydrophilic film B.
For this reason, in sample B1a, the water layer derived from the water | moisture content in respiratory air is hold | maintained on the surface of the hydrophilic membrane | film | coat B. FIG.
Moreover, in sample B1b, the water layer derived from the water | moisture content in the soot is hold | maintained on the surface of the hydrophilic membrane | film | coat B. FIG. This aqueous layer is also derived from the moisture in the respiratory air.
By holding such an aqueous layer on the surface of the hydrophilic film B, the simulated soot does not adhere to the surface of the hydrophilic film B and the flow of respiratory air, as will be described later in Test Example 2. And can be easily removed by a suction catheter.
Although not shown in Test Example 2 described later, even when the moisture in the body fluid contacts the outer surface of the luminal body at the indwelling site of the luminal body, the moisture remains on the inner surface side of the luminal body. The aqueous layer is held on the surface of the hydrophilic film B by passing through and contacting the hydrophilic film B.

  From the viewpoint of the strength of interaction with the polymer, the water layer composed of antifreeze water is a “strongly fixed layer” relatively strongly fixed to the hydrophilic film B, and the water layer composed of intermediate water is relative to the hydrophilic film B. In particular, the “medium fixing layer” fixed to a medium level and the water layer made of free water can be defined as “weak fixing layer” fixed relatively weakly to the hydrophilic film B.

For example, in the sample B1a, as shown in FIG. 4A, the strong fixing layer W ₁ and the weak fixing layer W ₃ are held in this order on the surface of the hydrophilic film B (indicated by reference numeral 150 in FIG. 4A). Yes. In FIG. 4A, the strong fixed layer W ₁ is held on the smooth surface of the hydrophilic film A denoted by reference numeral 150, and the weak fixed layer W ₃ is held on the strong fixed layer W ₁ . Aqueous layer on top of the weak anchoring layer W ₃ being absent, weak fixed layer W ₃ being strong relatively thinner than the fixed layer W _1.
Similarly, in the sample B1b, as shown in FIG. 4B, the strong fixed layer W ₁ and the weak fixed layer W ₃ are held in this order on the surface of the hydrophilic film B (indicated by reference numeral 150 in FIG. 4B). ing. In FIG. 4B, the strong fixed layer W ₁ is held on the smooth surface of the hydrophilic film A denoted by reference numeral 150, and the weak fixed layer W ₃ is held on the strong fixed layer W ₁ . Aqueous layer on top of the weak anchoring layer W ₃ being absent, the thickness of the reinforced fixed layer W ₁ and weakly fixed layer W ₃ being equal.
Thereby, the strong fixing layer W ₁ is protected by the weak fixing layer W ₃ , and the adhesion of wrinkles to the surface of the hydrophilic film B is suppressed by the protected strong fixing layer W ₁ .

[Test Example 1]
<Production of Copolymer A>
Dissolve 5 g (38.4 mmol) of methoxyethyl acrylate (MEA) and 0.55 g (1.9 mmol) of [3- (methacryloylamino) propyl] dimethyl (3-sulfopropyl) ammonium hydroxide in 22 g of methanol. Into a four-necked flask, N ₂ bubbling was performed at 50 ° C. for 1 hour to obtain a methanol solution 1.
Next, a methanol solution obtained by dissolving 0.006 g of 2,2′-azobis (4-methoxy-2,4-dimethylvaleronitrile) (V-70, manufactured by Wako Pure Chemical Industries, Ltd.) in 1 mL of methanol in methanol solution 1 2 was added and polymerized at 50 ° C. for 5 hours to obtain a polymerization solution.
The obtained polymerization solution was added dropwise to diethyl ether, and the precipitated copolymer A1 was recovered.
Content of the repeating unit (A) in copolymer A1 was 4.7 mol% with respect to all the repeating units. This was the same value as the content calculated from the charged amount.

<Preparation of coating agent A>
About the copolymer A1, a 0.5 mass% methanol solution was prepared and this was made into coating agent A1.

<Formation of hydrophilic film A>
As an alternative to the tracheostomy tube, a flexible PVC tube (inner diameter: 8.0 mm, outer diameter: 11.5 mm, length: 100 mm) was prepared. Hereinafter, this alternative is also referred to as a “tracheostomy tube”. The coating agent A1 was applied on the inner peripheral surface of the luminal body of the tracheostomy tube and dried at room temperature (25 ° C.) to form a hydrophilic film A1. The thickness of the hydrophilic film A1 was in the range of 1 to 1000 nm at any part.

<test>
<Artificial respiration conditions>
A simulated lung was connected to the distal end portion of the tracheostomy tube formed with the hydrophilic film A1 on the inner peripheral surface of the lumen body, and an artificial respirator was connected to the proximal end portion on the opposite side, and artificial respiration was performed under the following conditions. .
IPAP (positive intake pressure): 18.0 cmH ₂ O
EPAP (positive expiratory pressure): 3.0 cmH ₂ O
・ Number of breaths: 15 bpm
・ Intake air temperature: 24-28 ℃
・ Intake relative humidity: 75-100%
・ Time for artificial respiration: 50 hours

<< Simulation and suction conditions >>
During the artificial respiration, a simulated sputum was introduced into the lumen of the tracheostomy tube under the following conditions, and the simulated sputum was aspirated using a suction catheter under the following conditions.
-Simulated rice cake: 8% by mass aqueous paste paste (viscosity: 5000 to 10000 cP)
・ Number of simulated sputum injections: once every 15 minutes ・ Amount of simulated sputum injections: 0.25 mL / time ・ Number of suctions: once every 60 minutes ・ Suction conditions: −20 kPa, 20 seconds / time

"Test results"
During the artificial respiration, the behavior of the simulated sputum was confirmed by visually observing the lumen of the tracheostomy tube. The simulated sputum moved on the inner peripheral surface of the luminal body according to the flow of respiratory air. There was.
More specifically, it is confirmed that the simulated soot on the inner peripheral surface of the luminal body moves to the distal end side according to the flow of inspiration and moves to the proximal end side according to the flow of exhalation. It was done.
The simulated sputum that showed such behavior was easily sucked by the suction catheter.

<Confirmation of water layer formation>
On the aluminum foil, the coating agent A1 was applied in the same manner as described above to obtain a sample A1 in which the hydrophilic film A1 was formed.
Sample A1 was placed in the same environment as the artificial respiration environment described above, and then DSC measurement was performed. As a result, the presence of antifreeze water and intermediate water was confirmed (sample A1a).
In addition, the sample A1 was placed in the same environment as the artificial respiration environment described above, and then the simulated sputum was dropped, and then DSC measurement was performed. As a result, the presence of antifreeze water, intermediate water and free water was confirmed (sample A1b).
Therefore, in any case, it was found that the aqueous layer was retained in the hydrophilic film A.

[Test Example 2]
<Manufacture of polymer B>
29.7 g of triethylene glycol was added dropwise to 72.3 g of adipic acid dichloride at 50 ° C., and then hydrochloric acid was removed under reduced pressure at 50 ° C. for 3 hours, to 22.5 g of the resulting oligoester and 4.5 g of methyl ethyl ketone. Was added. This was added dropwise to a solution consisting of 5 g of sodium hydroxide, 6.93 g of 31% hydrogen peroxide, 0.44 g of surfactant dioctyl phosphate and 120 g of water and reacted at −5 ° C. for 20 minutes to obtain a reaction product. It was.
The obtained reaction product was repeatedly washed with water and methanol, and then dried to obtain a polyperoxide having a plurality of peroxide groups in the molecule.
Using 0.5 g of the obtained polyperoxide as an initiator and 30 g of benzene as a solvent, 9.5 g of glycidyl methacrylate (GMA) was polymerized with stirring at 80 ° C. for 2 hours under reduced pressure. After the polymerization, purification was performed using diethyl ether as a poor solvent and tetrahydrofuran as a good solvent to obtain polyglycidyl methacrylate (PPO-GMA) having a plurality of peroxide groups in the molecule.
Next, 9.0 g of dimethylacrylamide and 90 g of dimethyl sulfoxide as a solvent were charged into 1.0 g of the obtained PPO-GMA, sealed under reduced pressure, and then heated to 80 ° C. to carry out a polymerization reaction for 18 hours.
After the polymerization reaction, purification was carried out using diethyl ether as a poor solvent and tetrahydrofuran as a good solvent to obtain a block polymer having an epoxy group in the molecule. The obtained block polymer was confirmed to have an epoxy group in the molecule by NMR and IR measurements. The obtained block polymer was designated as a polymer B1.

<Preparation of coating agent B>
Polymer B1 (2 parts by mass) and pyridine (1 part by mass) as a catalyst were dissolved in 1,4-dioxane, and the resulting solution was used as coating agent B1.

<Formation of hydrophilic film B>
As an alternative to the tracheostomy tube, a flexible PVC tube (inner diameter: 8.0 mm, outer diameter: 11.5 mm, length: 100 mm) was prepared. Hereinafter, this alternative is also referred to as a “tracheostomy tube”. The coating agent B1 was applied on the inner peripheral surface of the lumen body of the tracheostomy tube and heated at 60 ° C. for 18 hours to form a hydrophilic film B1. The thickness of the hydrophilic film B1 was in the range of 1 to 1000 nm at any part.

<test>
<Artificial respiration conditions>
A simulated lung was connected to the distal end portion of the tracheostomy tube formed with the hydrophilic coating B1 on the inner peripheral surface of the luminal body, and an artificial respirator was connected to the proximal end portion on the opposite side, and artificial respiration was performed under the following conditions. .
IPAP (positive intake pressure): 18.0 cmH ₂ O
EPAP (positive expiratory pressure): 3.0 cmH ₂ O
・ Number of breaths: 15 bpm
・ Intake air temperature: 24-28 ℃
・ Intake relative humidity: 75-100%
・ Time for artificial respiration: 50 hours

<< Simulation and suction conditions >>
During the artificial respiration, a simulated sputum was introduced into the lumen of the tracheostomy tube under the following conditions, and the simulated sputum was aspirated using a suction catheter under the following conditions.
-Simulated rice cake: 8% by mass aqueous paste paste (viscosity: 5000 to 10000 cP)
・ Number of simulated sputum injections: once every 15 minutes ・ Amount of simulated sputum injections: 0.25 mL / time ・ Number of suctions: once every 60 minutes ・ Suction conditions: −20 kPa, 20 seconds / time

"Test results"
During the artificial respiration, the behavior of the simulated sputum was confirmed by visually observing the lumen of the tracheostomy tube. The simulated sputum moved on the inner peripheral surface of the luminal body according to the flow of respiratory air. There was.
More specifically, it is confirmed that the simulated soot on the inner peripheral surface of the luminal body moves to the distal end side according to the flow of inspiration and moves to the proximal end side according to the flow of exhalation. It was done.
The simulated sputum that showed such behavior was easily sucked by the suction catheter.

<Confirmation of water layer formation>
On the aluminum foil, the coating agent B1 was applied in the same manner as described above to obtain a sample B1 in which the hydrophilic film B1 was formed.
Sample B1 was placed in the same environment as the artificial respiration environment described above, and then DSC measurement was performed. As a result, the presence of antifreeze water and free water was confirmed (sample B1a).
In addition, the sample B1 was placed in the same environment as the artificial respiration environment described above, and then the simulated sputum was dropped, and then DSC measurement was performed. As a result, the presence of antifreeze water and free water was confirmed (sample B1b).
Therefore, in any case, it was found that the water layer was retained in the hydrophilic film B.

  The tracheal tube is not limited to the tracheostomy tube described based on FIG. 1 and FIGS. 2A to 2D, for example, a multi-tube shown in FIGS. 6 to 10 of International Publication No. 2016/052340 A tracheostomy tube and its inner tube; an endotracheal tube; a tracheal cannula that can be inserted into the trachea through a puncture or incision hole in the cricoid thyroid; a tracheal cannula that can puncture the cricoid thyroid membrane; a small tracheostomy tube; There may be.

DESCRIPTION OF SYMBOLS 5 Skin 6 Subcutaneous tissue 7 Trachea 7a Skin side tracheal mucosa 7b Body inner side tracheal mucosa 101 Tracheostomy tube 102 Lumen 102a Airway securing lumen 121 Base end part 122 Front end part 123 Curved part 127 Fixing part 128 Fixing board 129 Adhesive part 130 Through-hole 131 Storage hole 140 Water-repellent coating 150 Hydrophilic coating (hydrophilic coating A, hydrophilic coating B)
p Moisture permeable resin material W ₁ strong fixed layer W ₂ middle fixed layer W ₃ weak fixed layer X Body fluid Z 痰

Claims (1)

A distal end portion disposed on the lung side in the trachea, a proximal end portion provided on the opposite side of the distal end portion, and a lumen body having an airway securing lumen penetrating from the proximal end portion to the distal end portion. A tracheal tube,
At least a part of the lumen body is made of a water-permeable resin material,
A hydrophilic film is formed on at least a part of the inner peripheral surface of the lumen body,
The part of the luminal body made of the water-permeable resin material transmits the moisture in the body fluid that contacts the outer surface of the luminal body to the inner surface side of the luminal body at the indwelling part of the luminal body. Can be
In the non-immersed state, the hydrophilic film includes moisture in the respiratory air that passes through the lumen body, moisture contained in the sputum that passes through the lumen body, and moisture that has permeated the inner surface side of the lumen body. A tracheal tube characterized in that an aqueous layer can be retained on the surface by at least one selected from the group consisting of: