WO2005082303A1

WO2005082303A1 - Implanted artificial eustachian tube

Info

Publication number: WO2005082303A1
Application number: PCT/JP2005/002724
Authority: WO
Inventors: Masahiro Morita
Original assignee: Masahiro Morita
Priority date: 2004-02-26
Filing date: 2005-02-21
Publication date: 2005-09-09
Also published as: JPWO2005082303A1

Abstract

An artificial Eustachian tube being a therapeutic implanted implement that is useful for the therapy of Eustachian tube insufficiency and is capable of closing any puncture of the tympanic membrane so as to recover an intra-tympanum environment highly close to physiological condition. There is provided artificial Eustachian tube (111) to be implanted in the human Eustachian tube, comprising stent member (115) having forefront portion (113) adapted to pass through the isthmus of Eustachian tube and to be disposed in the cartilaginous part of Eustachian tube and having rear end portion (114) adapted to be disposed in the tympanum or the osseous part of Eustachian tube, characterized in that the forefront and rear end of the stent member communicate with each other through a tubular hollow, and that at a forefront region the tubular hollow opens from the tube through first opening (121) while at a rear end region the tubular hollow opens from the tube through second opening, and that the stent member is furnished with (a) at the rear end portion at least partially an enlarged outer diameter part of ≤8 mm upper limit and/or projection (116) rising from the external surface of the stent member, and/or (b) at a region ≥2 mm apart from the forefront and within 12 mm of the first opening, constricted portion (120) for engaging the isthmus of Eustachian tube.

Description

Specification

Implantable ear canal

Technical field

The present invention relates to an artificial ear canal for implantation into a human ear canal through an eardrum.

Background art

[0002] The ear includes an outer ear, a middle ear, and an inner ear. The outer and middle ears are separated by the eardrum located at the inner end of the ear canal. The middle ear consists of the tympanic cavity (the middle ear cavity), which is the space containing the ossicles (clavicle, chinuta, and stapes) that connect the tympanic membrane and the vestibular window (which leads to the vestibule of the inner ear). And an Eustachian tube that opens to The Eustachian tube begins in the antrum of the eardrum (tympanic ear canal), extends diagonally from the superior posterolateral to the inferior medial side and opens at the pharyngeal side wall (Eustachian pharyngeal orifice). The Eustachian tube is about 33 mm in length, about 1/3 of the upper side passes through the temporal bone, and about 2/3 of the lower side is wrapped in cartilage. The bony eustachian tube gradually widens through the narrowed ear canal ostium and then gradually narrows, and becomes thinnest at the cartilage entrance site (the eustachian canal region).

), Normally closed at this position. Below the eustachian canal, the Eustachian tube becomes progressively thicker and opens to the pharyngeal orifice of the Eustachian tube. One of the functions of the Eustachian tube is its ventilation function. This is because the lower wall of the cartilage is pulled down due to the contraction of the palatine tractor muscles during the yawning and swallowing, the lumen of the eustachian canal temporarily opens, and air flows from the pharynx into the tympanic cavity. It can be divided into the active type and the passive type, in which ventilation is performed passively in response to changes in external pressure. In the healthy ear, the tympanic pressure is kept equal to the outside pressure because of the ventilation function of the Eustachian tube, especially the active ventilation function. The Eustachian tube also has the function of excreting secretions from the middle ear into the pharynx. Conditions in which these functions are impaired, ie, Eustachian tube dysfunction, include Eustachian tube stenosis (Eustachian tube obstruction), Eustachian tube openness, and Eustachian tube insufficiency.

[0003] Eustachian tube stenosis is a state in which the dilation of the Eustachian tube caused by swallowing, deficiency of elongation or the like is impaired for some reason, and ventilation of the middle ear via the Eustachian tube is impaired. Causes include organic stricture of the Eustachian tube due to inflammation of the nasopharynx and functional stenosis due to dysfunction of the pancreas eustachianis (cuff palatine muscle) such as cleft palate. If the eustachian tube stenosis obstructs the ventilation of the middle ear, oxygen in the tympanic membrane is absorbed by the surrounding mucosa and negative pressure in the tympanic membrane causes the tympanic membrane to collapse. The result It causes symptoms such as fruit sensation, hearing loss, hearing loss, and loud hearing. Prolonged eustachian tube stenosis may lead to exudative otitis media. This is a disease in which the exudate leaks into the middle ear cavity as a result of the sustained negative pressure in the tympanic cavity, causing the exudate to fill the tympanic cavity, causing conducive hearing loss, a feeling of ear obstruction, and recurrent acute otitis media It is also easy to be affected. In addition, when the tympanic chamber is exposed to chronic and irreversible negative pressure, the tympanic membrane adheres to the middle ear wall, which is an intractable otitis media, or in the middle ear cavity, which is not originally epithelial. The keratinized squamous epithelium proliferates and destroys the surrounding bones in the process, causing the disease cholesteatoma otitis media.

In the treatment of Eustachian tube stenosis, so-called Eustachian tube aeration therapy, in which a catheter is inserted into the pharyngeal orifice and ventilated, is frequently used. Other treatments include injecting steroid hormones into the Eustachian tube from the pharyngeal or tympanic side, and injecting steroid hormones submucosally around the pharyngeal orifice. It has not been established. Conservative treatment with medication involves systemic administration of anti-inflammatory enzyme preparations, drugs with anti-allergic effects, and nasal instillation of steroids, but it requires long-term medication and is effective in moderate to moderate cases. There is a problem that it is often not enough. For patients who do not respond to pharmacotherapy, placement of an eardrum tube is also performed to ensure ventilation of the tympanic chamber. The tympanic tube is a tube fitted into a perforation provided in the tympanic membrane, and is commercially available in various sizes and shapes. A central constricted tube with a length of about 3 mm is one of the commonly used ones. In some tympanic tubes, the ventricle can be ventilated. The Eustachian tube stenosis itself cannot be sufficiently improved, and the ventilation and excretory function through the Eustachian tube is not always restored. In addition, the eardrum tube usually falls off in a few months or 11 years due to repair of the perforation of the eardrum, so if the eustachian tube stenosis has not been improved, the eardrum tube must be re-established to secure ventilation. Ube detention is also required. Recently, a treatment method that ablates the mucous membrane in the Eustachian tube from the pharyngeal orifice side with a laser (carbon dioxide laser, KTP laser) has been developed for cases resistant to drug treatment. However, there are many unclear points about the effect on the surrounding tissue when cauterizing the deep part near the eustachian canal.However, sufficient anatomical knowledge and advanced It is essential to master various surgical techniques Not yet done.

[0005] In addition, open ear canal disease refers to a state in which the Eustachian tube is always open, and as a patient's subjective symptom, self-intensified hearing due to his / her own voice reaching the middle ear via the Eustachian tube. Some people complain of dizziness because they can hear their breathing sounds and have a feeling of closed ears. The patient's eardrum is normal, but is observed to move back and forth with breathing. Causes of Eustachian tube openness include atrophy of the nasal mucosa due to aging and neurological diseases, atrophy of the mucosa around the Eustachian tube due to weight loss, and scarring after adenoid surgery, but the cause is unknown in many cases.

[0006] Pharmacotherapy for open Eustachian tube disease includes spraying a mixed powder of boric acid and salicylic acid into the Eustachian tube using an Eustachian catheter, such as the Bezold method, and injecting a gelatin sponge solution into the Eustachian tube cavity. Surgical treatments include injections of liquid silicone, cautery of the otomucosa, movement of the patellar tractor muscles, implantation of cartilage fragments or adipose tissue around the Eustachian tube, and collagen injection. Pharmaceutical treatment requires long-term continuous treatment, and there is a problem that surgical treatment is ineffective. In addition, as a device for treating Eustachian tube openness and Eustachian tube deficiency, a flat-shaped tapered Eustachian pin that is placed in the lumen of the middle ear canal about 5 to 15 mm deep from the eardrum is proposed. However, it works to block the cross section of the Eustachian tube and cannot be applied to Eustachian tube stenosis.

[0007] Furthermore, a so-called floppy tube has recently attracted attention from the aspect of the Eustachian tube function. A floppy tube is an Eustachian tube that is easily closed and easily opened, and the Eustachian tube is opened when yawning and swallowing, resulting in self-voiced hearing and a sense of ear closure. In order to resolve these discomforts, patients often unknowingly nose-slip (which causes negative pressure in the eardrum and closes the Eustachian tube). And, if placed in an irreversible negative pressure condition, it may cause otitis media with effusion, adhesive otitis media and cholesteatomas, as described above in connection with eustachian tube stenosis.

[0008] As described above, abnormalities in the Eustachian tube function cause various diseases of the middle ear, and a floppy tube that causes Eustachian tube stenosis, Eustachian tube openness, or both obstruction and opening is effectively and simply used. There is also a need for a reliable treatment method that can be used for the treatment of otitis media with adhesion, for preventing the adhesion of the tympanic membrane after the operation for otitis media with effusion, and for preventing the recurrence of pearls. [0009] For this purpose, the present inventor first inserted a tube having a predetermined shape having an opening for ventilation in the tube wall from the side of the eardrum into the eustachian canal through the eardrum, and then inserted the tip into the cartilage canal. In addition, by positioning the opening of the tube wall in the tympanic chamber and fixing the rear end of the tube through the tympanic tube attached to the eardrum, Can communicate between the nasal cavity and the tympanic chamber to restore the physiological and ventilatory function through the Eustachian tube to a physiologically close state, and also excessively spread to Eustachian tube openness and Eustachian tube insufficiency. It was found that appropriate communication between the nasal cavity and the tympanic cavity could be secured through the lumen of the tube by closing at least a part of the section of the canal of the ear canal. Focusing on the fact that such a tube is extremely effective in treating Eustachian tube dysfunction and can become an "artificial ear canal", based on this, a tube of a predetermined form can be used. Developed and filed a patent application for this (see Patent Document 2) Patent Document 1: Japanese Patent Application Laid-Open No. 2002-224157

Patent Document 2: Japanese Patent Application No. 2003-375097

Disclosure of the invention

Problems to be solved by the invention

[0010] Although the above-mentioned artificial ear canal has an extremely excellent therapeutic effect, it is designed to prevent displacement by fixing the posterior end to the eardrum tube fitted on the eardrum. It is assumed that a perforation is left in the eardrum. Against this background, the present invention is effective in the treatment of Eustachian tube stenosis (Eustachian tube obstruction), Eustachian tube openness, Eustachian tube insufficiency and Eustachian tube dysfunction including floppy tube, It is an object of the present invention to provide a therapeutic loading device and a therapeutic method capable of achieving the same therapeutic effect while restoring the intratympanic environment closer to a physiological state by enabling perforation closure. Means for solving the problem

That is, the present invention provides the following.

(1) In a human ear canal comprising a tubular body whose distal end is located in the cartilage ear canal through the eustachian canal and whose rear end is located in the tympanic cavity or in the bone canal. An artificial ear canal to be carried in

The front end and the rear end of the tubular body are communicated by a lumen, In the distal region, the lumen opens out of the lumen through the first opening;

In the posterior end region, the lumen opens extraluminally through the second opening, and the tubular body is

(a) at the rear end, at least partially having an outer diameter enlarged portion having an upper limit of 8 mm or less and / or having a projection rising from the outer peripheral surface of the tubular body; and

(b) A constriction for engaging with the eustachian canal is provided in an area at least 2 mm from the tip and within 12 mm from the first opening.

An implantable artificial ear canal, characterized in that:

(2) The implantable artificial ear tube according to (1), wherein the projection comprises at least two projections rising from at least two places of the tubular body.

(3) The implantable artificial ear tube according to the above (1) or (2), wherein a tip of the projection reaches a distance of 1.5 to 5 mm from a central axis of the tubular body.

(4) The carrier according to any of (1) to (3) above, wherein the lumen has a diameter of 0.20 mm or more, and has at least a part not exceeding 0.8 mm. Recessed artificial ear canal.

(5) The implantable artificial ear tube according to any one of (1) to (4) above, wherein the outer diameter of the distal end portion is in a range of 0.335-3. Omm.

(6) The implantable ear canal according to any of (1) to (5) above, wherein the outer diameter of the tip is 0.35 to 1.7 mm.

(7) The implantable ear canal according to any one of (1) to (6), wherein the projection is inclined toward a rear end of the tubular body.

(8) The implantable artificial ear canal according to any of the above (1) to (7), wherein the projection has a length of 116 mm.

(9) The above (1), wherein the tubular body has, within a range of 215 mm from the first opening, a third opening communicating with the lumen and opening outside the tube. The implantable artificial ear canal according to any one of (8) and (7).

(10) The implantable artificial ear according to any of (1) to (9) above, wherein the distal end has a smaller outer diameter than the rear end of the tubular body. tube. (11) The implantable artificial ear canal according to any one of (1) to (10), wherein the total length is 15 to 45 mm.

(12) The above-mentioned (1) to (11), wherein the tubular body has, within a range of 2 to 12 mm from a rear end thereof, a fourth opening which is open to the outside of the tube in communication with the lumen. ) Any implantable ear canal.

(13) The artificial ear canal according to the above (1) to (12), having the above feature (b), wherein the length of the constricted portion along the longitudinal direction of the tubular body is 0.5 to 5 mm. Artificial ear canal.

(14) The artificial ear canal according to any of (1) to (13) above, which has the above feature (b), wherein the constricted portion has an outer diameter of 3: An artificial ear canal having an outer diameter in the range of 11:11.

(15) The artificial ear canal according to the above (1) to (14), having the above feature (b), comprising a protrusion rising from the outer peripheral surface of the tubular body adjacent to the distal end side of the constricted portion. What is an artificial ear canal.

(16) The implantable ear canal according to any one of the above (1) to (15), which is formed of a flexible material.

(17) The implantable ear canal according to any of the above (1) to (16) is inserted transeurally into the ear canal of a human patient having eustachian tube dysfunction, and A method for treating human Eustachian tube dysfunction by placing the tip in the cartilage eustachian tube through the Eustachian canal and the posterior end in the tympanic cavity or in the bony eustachian tube and fixing it at that position .

The invention's effect

The implantable ear canal of the present invention having each of the above-mentioned configurations connects the cartilage ear canal with the eardrum through the first opening, the second opening, and the lumen connecting them. Communication is ensured, thereby ensuring ventilation between the nasal cavity and the tympanic chamber in patients with Eustachian tube stenosis (Eustachian tube obstruction). In patients with Eustachian tube openness or Eustachian tube deficiency, excessive ventilation between the nasal cavity and the tympanic cavity is corrected, and through the lumen of the implantable artificial Eustachian tube inserted into the Eustachian tube. Provides a moderate ventilation state. Furthermore, for a patient having a floppy tube, the open or closed state of the Eustachian tube is removed to restore an appropriate ventilation state. Also, the implantable ear canal of the present invention can be connected to the artificial ear canal through the lumen or by implantation. Through the gap formed between the mucous membrane of the ear canal and the surrounding area of the ear canal to recover or ensure excretion of exudate from the tympanic cavity into the nasal cavity. Therefore, the implantable ear canal of the present invention is effective for fundamentally treating various middle ear diseases caused by these eustachian tube dysfunctions. After insertion into the Eustachian tube, the implantable artificial Eustachian tube of the present invention can be connected to the inner wall of the tympanic chamber or the inner wall of the bone Eustachian tube (when the posterior end has a protrusion and / or an enlarged outside diameter). Or, if it has a constriction, it is fixed in place by physical interaction with the ear canal, so it is not necessary to fix the posterior end to the eardrum. It can also be left loaded so that it does not need to be removed later. Therefore, with the use of the implantable artificial ear canal of the present invention, the perforation of the tympanic membrane created during the operation can be left to repair and close after the operation. After the perforation is closed, there is no risk of infection of the middle ear or foreign matter in the outer ear, and the physiological atmosphere is restored to the tympanic chamber, which is cut off from the outside air, enabling a more physiological life in the eardrum This has excellent effects on both the treatment of the target disease and the quality of life of the patient after treatment.

Brief Description of Drawings

FIG. 1 is a side view of an implantable ear canal of Example 1.

FIG. 2 is a side view of an implantable artificial ear canal of Example 2.

FIG. 3 is a side view of the implantable ear canal of Example 3.

FIG. 4 is a side view of the implantable ear canal of Example 4.

FIG. 5 is a side view of the implantable artificial ear canal of Example 5.

FIG. 6 is a perspective view showing a specific example of the shape and arrangement of projections.

FIG. 7 is a perspective view showing a specific example of the shape and arrangement of projections.

FIG. 8 is a perspective view showing a specific example of the shape and arrangement of projections.

FIG. 9 is a rear end view showing an example of the arrangement of protrusions.

FIG. 10 is a rear end view showing an example of the arrangement of protrusions.

FIG. 11 is a rear end view showing an example of the arrangement of protrusions.

FIG. 12 is a side view of the implantable artificial ear canal of Example 6.

FIG. 13 is a side view of the implantable artificial ear canal of Example 7.

FIG. 14 is a side view of the implantable ear canal of Example 8. FIG. 15 is a side view of the implantable ear canal of Example 9.

FIG. 16 is a partially enlarged view of the implantable artificial ear canal of Example 9.

FIG. 17 is a partially enlarged view of the implantable artificial ear canal of Example 10.

FIG. 18 is a side view of the implantable artificial ear canal of Example 11.

FIG. 19 is a perspective view of the vicinity of a distal end portion and a constricted portion of the implantable artificial ear canal of Example 11.

[FIG. 20] A conceptual diagram showing the principle of an Eustachian tube function test by the pressurization / decompression method

[Figure 21] Conceptual diagram showing the principle of the acoustic auditory canal function test method

Explanation of symbols

1 = Eustachian tube, 2 = Lumen, 3 = Tip, 4 = Posterior, 5 = Tubular, 6, 6a, 6b, 6c, 6d = Protrusion, 7 = Opening (4th opening), 8 = Stenosis Parts, 10a, 10b = opening, 11 = ear canal, 13 = tip, 14 = posterior, 15 = tubular body, 16 = protrusion, 17 = opening (fourth opening), 18 = constriction, 19 = opening (Third opening), 21 = artificial ear canal, 23 = distal end, 24 = posterior end, 25 = tubular body, 26 = protrusion, 27 = opening, 28 = constriction, 29 = opening, 31 = artificial ear tube, 33 = distal end, 34 = posterior end, 35 = tubular body, 36 = protrusion, 37 = opening, 38 = constriction, 39 = opening, 41 = artificial ear canal, 43 = distal end, 44 = posterior end, 45 = tubular part , 46 = protrusion, 47 = opening, 48 = constriction, 49 = opening, 51 = artificial ear tube, 53 = tip, 54 = posterior end, 55f = distal tube, 55 s = shaft tube, 56 = Protrusion, 57 = open, 58 = stenosis, 59 = open, 61 = artificial ear canal, 63 = distal, 64 = posterior, 65f = distal tube, 65m = middle tube, 65s = posterior Tube, 66 = Protrusion, 67 = open, 68 = constriction, 69 = open, 71 = artificial ear canal, 73 = distal, 74 = posterior, 75f = distal tube, 75m = middle tube, 75s = posterior Tube, 76 = protrusion, 77 = opening, 78 = stenosis, 79 = opening, 80 = opening (first opening), 81 = artificial ear tube, 83 = distal, 84 = posterior, 85f = distal tube 85m = middle tube, 85s = posterior tube, 86a, 86b = protrusion, 87 = opening, 88 = constriction, 89 = opening, 90 = short tube, 94 = posterior, 95s = posterior Tubes, 96a, 96b = protrusion, 100 = short tube, 101 = slit, 141 = pressure transducer, 142 = amp, 143 = recorder, 151 = acoustic test function analyzer, 111 = artificial ear tube, 113 = tip , 114 = posterior end, 115 = tubular body, 116 = protrusion, 118 = constriction, 119 = opening, 120 = constriction, 121 = opening (first opening)

BEST MODE FOR CARRYING OUT THE INVENTION [0015] The second opening of the artificial ear canal according to the present invention achieves communication between the patient's ear canal and the cartilage ear canal through the lumen of the artificial ear canal to allow ventilation between the ear canal and the nasal cavity. One purpose is to secure. Therefore, the insertion of the artificial ear canal into the patient should be such that the distal end of the artificial ear canal passes through the eustachian canal into the cartilage canal and the first opening in the distal region opens into the cartilage canal, and The second opening in the posterior end region is made to be located in the tympanic chamber or in the bone canal. In order to meet this purpose, the artificial ear canal of the present invention having an appropriate size according to the length and thickness of the patient's ear canal is used according to a doctor's selection.

[0016] In the present invention, the first opening in the front end region and the second opening in the rear end region are, for example, both formed by opening the lumen of the tubular body in the axial direction at the front end and the rear end, respectively. However, the present invention is not limited to this. For example, alternatively, the lumen may be axially closed (blind end) at the tip and the opening may be provided on the side of the tip region. For example, if the distal end of the tubular body has such a form, when inserting the artificial ear canal into the ear canal using a guide wire passed through the lumen, even if the guide wire is smaller than the inner diameter of the distal end portion Even in the case of a small diameter, the guide wire stops after hitting the inside of the tip of the artificial ear canal, and it is easier to remove only the guide wire after insertion of the artificial ear canal without risk of slipping forward, which contributes to simplification of the operation. In the present invention, the “tip region” of the tubular body refers to the tip and its vicinity, and “near” refers to a range usually within 2 mm or 3 mm from the tip. Further, in the present invention, the “rear end region” refers to the rear end and the region arranged in the tympanic chamber. The term "tip" refers to the portion of the artificial ear canal corresponding to the tip region, and the term "posterior end" refers to the posterior end and posterior end of the artificial canal placed in the tympanic chamber or further in the bony ear canal. The part near the edge.

[0017] In the present invention, when the posterior end disposed in the tympanic cavity or the bony ear canal has an outer diameter enlarged portion, the maximum diameter of the portion is, for example, 3 mm, 3.5 mm, 4 mm, 5 mm, It can be 6 mm, 8 mm, etc. The shape of such an outer diameter enlarged portion may be a columnar shape, or may have a contour whose outer diameter increases or decreases in a curve along the longitudinal direction. A part that includes a reduced outer diameter portion such as a concave portion or a groove is also included in such an outer diameter enlarged portion as long as the outer diameter is increased as a whole. Further, as an example having a profile in which the outer diameter increases and decreases in a curve along the longitudinal direction, an outer peripheral surface in the middle of the rear end portion has a spherical or round shape. One having a swelling shape such as the surface of a spheroid is exemplified.

Further, it is sufficient to provide, for example, 2 to 6, more preferably 3 to 4, plural protrusions rising from two or more places on the outer peripheral surface of the rear end portion. However, a larger number can be provided. These projections can be distributed (eg, evenly) around the periphery of the portion of the prosthetic ear canal so as to face as many directions as possible from the central axis of the tubular body. Further, the arrangement positions can be dispersed also in the longitudinal direction of the artificial ear canal. For example, at a first position in the longitudinal direction (for example, at a position 8 mm from the rear end of the tubular body), a plurality of projections of a first group are dispersedly arranged along the outer periphery, and a second position (for example, At the position (4 mm from the rear end of the body), the second group of 23 projections can be similarly dispersed along the outer circumference.

[0019] In the implantable artificial ear canal of the present invention, in the case where a particularly enlarged portion of the outer diameter is provided at the posterior end to be placed near the ear canal orifice in the tympanic cavity or in the bony ear canal. Usually, the portion is preferably within a region from the rear end to 10 mm, more preferably from 8 mm to the rear end, or up to 5 mm from the rear end. Also, when providing a plurality of projections, it is more preferable to provide them so as to fall within these ranges.

[0020] Even short projections can help fixation when applying a bone putty, so the length of the projection provided at the rear end is not necessarily limited, but it is usually set to be 16mm, more preferably 2-4mm. Power It is convenient because it is versatile and convenient, and it can exert its fixing function by itself. The shape of the projection is not particularly limited, and may be, for example, a rod-like or plate-like shape, a uniform width, or a tapered shape. The width of the projection may be a width that is not inconvenient for disposing the projection on the outer peripheral surface of the tubular body. For example, it can be about 1 mm at the root, for example 0.8-1.2 mm. In the case of a plate-shaped projection, the thickness can be, for example, 0.1-0.2 mm or the like, but is not limited thereto.

[0021] In the implantable artificial ear canal of the present invention, a portion of 112 mm from the first opening in the distal end region exceeds the eustachian canal and is located in the cartilage ear canal, and the remaining portion is located in the bone canal or The specific shape and dimensions may be determined so as to be placed from the bony ear canal to the tympanic cavity.

[0022] The protrusion at the rear end of the tubular body can be provided on the outer periphery of the tubular body by an appropriate method. For example, the tubular body and the projection may be integrally molded with a molding material such as a synthetic resin, or the The separately formed tubular body and the projection may be integrated by heat fusion and adhesion.Furthermore, a cut having the shape of the desired projection is made in the rear end wall of the tubular body. Then, the portion may be pulled out of the tubular body and projected. In this last case, an opening of the same shape occurs after the projection has been outwardly projected, which is not disadvantageous for the implantable ear canal according to the invention.

[0023] Alternatively, a short tubular object having a plurality of protrusions arranged by the above-described method may be covered on the outer periphery of the rear end of the tubular body, and the two may be integrated by heat fusion or adhesion. Thus, a form in which a plurality of protrusions are arranged on the outer diameter enlarged portion may be achieved. Further, in this case, if the inner diameter of the outer tubular body is smaller than the outer diameter of the inner tubular body (for example, when both are based on the same size pipe), the outer tubular body has a shaft attached to the wall. It is also possible to insert a slit in one direction so that the tube can be opened, and to cover the outer periphery of the inner tubular body. By doing so, the outer tubular material has a slit wide enough to fit the inner tubular body, so that the outer tubular material is fitted around the inner tubular body with the inner circumference of the outer tubular body tightly fitted. be able to. Thereafter, the two contact surfaces can be integrated by heat sealing or bonding.

[0024] The rear end portion of the implantable artificial ear canal of the present invention, which is located in the tympanic cavity or in the bony ear canal, is provided with the above-described outer diameter enlarged portion and / or has a protrusion that rises in outer peripheral force. In any case, the provision of the implantable artificial ear canal of the present invention inserted into a human ear canal prevents the predetermined insertion position from being shifted (toward the nasal cavity or the eardrum). Useful.

[0025] That is, the plurality of projections provided on the outer periphery of the posterior end allow one or more of the distal ends to abut on the inner wall of a narrow tympani or a bony ear canal to form an artificial ear canal. By providing resistance to misalignment, it acts to fix the artificial ear canal in place. The enlarged outer diameter at the rear end prevents the Eustachian tube from falling into the nasal cavity. Also, when the rear end of any of the enlarged diameter part and / or the projection is provided in the tympanic cavity, a small amount of bone putty shall be applied to the gap between the surface and the tympanic wall. Accordingly, the force S can be used for fixing the artificial ear canal so that it does not deviate from the predetermined position in any of the front and rear directions. If a projection is provided on the outer diameter enlarged portion, the projection and the inner wall of the tympanic chamber are provided. Not only is the physical interaction with the bone increased, the slip of the artificial ear canal is more effectively prevented, but also the fixation by applying the bone putty is further ensured.

[0026] Although it is not essential that the projection at the rear end is provided as a whole inclined toward the rear end, it is preferable. This is because if the protuberance is so inclined, even if the artificial Eustachian tube tries to retreat in the direction of the outer ear, the protuberance whose tip abuts against the inner wall of the tympanic membrane or the inner wall of the bone canal will be pushed, creating resistance. This is because retreat can be more effectively prevented. The angle of inclination (the angle formed by the straight line connecting the root and the tip of the projection to the central axis of the Eustachian tube) is usually in the range of 30-70 °, preferably in the range of 40-50 °. More preferred. The present invention is directed to such a use condition in which the angle of inclination of the projection can be manually adjusted by the operator during use if the material forming the projection is flexible. Also includes those having projections that are inclined toward the rear end.

[0027] It is preferable that the tip of the above-mentioned projection reaches a range of 1.5 to 5 mm from the center axis. With such a length, the rear end portion of the various outer diameters of the tubular body is also brought into contact with the inner wall of the intratympanic wall or the inner wall of the bone eustachian tube, thereby displacing the position of the implantable ear canal. Can be prevented.

The lumen of the implantable artificial ear canal of the present invention preferably has a diameter of at least 0.20 mm or more. This is because, if the diameter of the lumen is too narrow, there is substantially less concern if the force that can cause resistance to the flow of air (and possibly leachate) in it is 0.20 mm or more. Conversely, if the lumen of the artificial Eustachian tube is too large over its entire length, there is a risk that the self-voice will be conducted into the tympanic cavity by air. In order to prevent this, at least one of the channels up to the first opening force of the artificial ear canal and the second opening (the fourth opening if the fourth opening described later is provided). At the position, the diameter of the flow path should be partially narrowed. In this case, the lower limit of the diameter of the constricted portion is 0.20 mm, but the upper limit is preferably 0.8 mm or less, more preferably 0.6 mm or less. By doing so, even when the diameter of the remaining part of the flow path is large, the constriction provided in the flow path functions as an eruption of the ear canal, and prevents self-voice from being conducted to the eardrum.

[0029] The thickness of the patient's Eustachian tube varies depending on the patient's physique (eg, adults and children) and also between types of Eustachian tube dysfunction. For example, in Eustachian tube stenosis (Eustachian tube obstruction), In some cases, the ear canal is too narrow to allow the insertion of a prosthetic ear canal with a diameter of at most 0.35 mm at the most, while the ear canal is larger, for example, 0.5 mm, 0.8 mm, 1.0 mm, etc. In some cases, an artificial ear canal having an outer diameter of the distal end portion can be inserted. In cases of Eustachian tube sufficiency or Eustachian tube openness, depending on the patient, an artificial canal can be inserted without difficulty even with an artificial eustachian tube having an outer diameter of about 3 mm at the tip of the Eustachian canal. Since the size of the lumen of the canal canal can be estimated almost correctly from the CT image of the problem area, artificial ears of various dimensions with an outer diameter of 0.35 to 3.0 mm can be estimated. From the tube, a tube having a thickness suitable for the patient, for example, 0.35 mm, 0.5 mm, 0.8 mm, 1.0 mm, 2.0 mm, 2.5 mm, 3.0 mm, etc. may be appropriately selected. . If the outer diameter of the tip is relatively smaller than the other parts, it can be, for example, in the range of 0.35 to 1.7 mm, and several types of such diameters should be prepared. If this is the case, an artificial Eustachian tube suitable for introducing into the Eustachian Canal that has been narrowed to various degrees in patients with Eustachian tube stenosis can be selected and used. In the case of an artificial ear canal having a constricted portion adjacent to the distal end, the outer diameter of the distal end is more preferably 0.8 mm or more in consideration of the strength of the constricted portion.

[0030] In carrying out the embedding, a guide wire is usually passed through the implantable artificial ear tube of the present invention from the rear end side into the lumen, and is inserted into the ear tube while being supported thereby, and the distal end portion is inserted. After insertion into the cartilage canal, only the guidewire is removed, leaving only the prosthetic ear canal, with its rear end placed in the tympanic cavity or in the bone canal. Therefore, at the time of insertion, it is preferable that the lumen of the artificial ear canal is open through the lumen as it is.

[0031] The implantable artificial ear canal of the present invention is inserted into the patient's ear canal so that the tip passes through the eustachian canal and reaches the cartilage canal. It is preferable that the first opening in the distal end region of the artificial ear canal is inserted so as to exceed the eustachian canal by 1 mm or more, or 2 mm or more. This is because the tip of the artificial ear canal can be stably placed, and there is no possibility that the position of the artificial ear canal is slightly shifted (retracted) and the first opening in the distal end area is blocked by the eustachian canal. It is. It is preferable that the position of the first opening in the distal end region of the artificial eustachian tube does not exceed about 12 mm from the eustachian canal. This is because it is easier to prevent contamination from the nasal cavity if the tip of the artificial eustachian tube is not too close to the pharyngeal orifice.

[0032] The implantable artificial ear canal of the present invention is positioned such that the distal end thereof exceeds the eustachian canal from the eardrum side. It is suitable for insertion and fixation until the first opening is reached, but with the first opening in the tip region remaining within about 12 mm from the eustachian canal. When fixed in this manner, the first opening opens into the cartilage ear canal to allow the lumen of the artificial ear canal to communicate with the cartilage ear canal (and the nasal cavity), while at the posterior end region of the artificial ear canal. A certain second opening will be located in the tympanic cavity or in the bony ear canal, thereby establishing communication between the tympanic cavity and the nasal cavity. This communication not only functions to eliminate the pressure difference between the tympanic cavity and the outside world (ventilation function), but also functions to discharge secretory fluid to the nasal cavity side (excretion function) if there is any in the tympanic cavity. be able to. The length of the Eustachian tube differs depending on the patient, especially for adults and children, but for each patient, the length of the Eustachian tube must be ascertained by CT images, etc. Depending on whether the tube is inserted, even if the posterior end is located in the tympanic chamber when the tube is introduced, the artificial ear tube according to the present invention is stored so that the posterior end is accommodated without fear of coming into contact with the eardrum. It is only necessary to select and use those with appropriate dimensions.

The size of the second opening is not particularly limited as long as it does not prevent the pressure difference between the eardrum and the nasal cavity through the artificial eustachian tube from being eliminated. It is more preferable that the opening is wider than the opening of the artificial ear canal so that it is easy to flow into the artificial ear canal through the second opening and to flow down when the exudate is present. Even when exudate enters the artificial eustachian tube, since the exudate rises and falls according to the pressure fluctuation between the tympanic cavity and the nasal cavity, there is substantially no pressure difference between the tympanic cavity and the nasal cavity. Function is preserved).

[0034] The cross-sectional shape of the implantable artificial ear canal of the present invention is not particularly limited, but is generally preferably circular or oval. The cross-sectional shape may be the same over the entire length of the artificial ear canal, such as being circular over the entire length of the ear canal, but it is not necessary that the cross-sectional shape be circular for most of the entire length and partially (for example, at the tip). It may be elliptical, or may be elliptical for most of its length and circular for some (eg, tip). In the case of an ellipse, the ratio of the major axis to the minor axis is allowed up to a maximum of 4. The cross section of the Eustachian canal has a flat shape that extends in the front-back direction rather than the left and right.If the tip of the artificial Eustachian tube has an elliptical cross section, it is fitted to most of the entire inner circumference of the Eustachian canal. This is advantageous for easily closing the extra lumen of the eustachian canal for easy open Eustachian tube. Also, for example, in the case of Eustachian tube stenosis, when an artificial Eustachian tube having a generally circular cross section at the tip is inserted into the Eustachian canal, this may result. As a result, a slight gap is formed between the outer wall of the distal end of the artificial Eustachian tube and the inner wall of the Eustachian gorge to push the flat inner periphery of the Eustachian canal to some extent. This is advantageous in securing an excretory channel. Which cross-sectional shape of the artificial ear canal of the present invention is most preferable is selected by the attending physician according to the shape and dysfunction of the patient's ear canal. It is.

In the present invention, the “diameter” of the implantable ear canal means the diameter when the cross-sectional shape of the ear canal is circular, and the length of the minor axis when the oval is oval. In addition, for each opening of the artificial ear canal, the term "diameter" refers to the diameter in the case of a circular shape, the long and thin shape such as an ellipse and an oval, and the short diameter and )

[0036] The implantable artificial ear canal according to the present invention has a drainage outlet for allowing the exudate to enter the lumen through the second opening, to be luminally discharged, and quickly excreted into the nasal cavity side. A third opening can be provided to serve as a service. As already mentioned, the Eustachian canal has a flat cross-sectional shape by nature, so when an artificial Eustachian tube is inserted into this area, the Eustachian canal that is completely in close contact with the entire cross section of the Eustachian canal is not pushed. As far as possible, a gap pushed by the artificial ear canal will be formed around the artificial canal in the eustachian canal into which the artificial ear canal is inserted, and this gap will be a passage for the flow of exudate. Third opening force in the Eustachian tube When located at or just above the Eustachian canal, the exudate that has entered the lumen of the Eustachian tube drains out of the tube through the third opening with the aid of its own weight and surface tension However, it can easily flow down the cartilage into the Eustachian tube and into the nasal cavity through the gap formed in the Eustachian canal, which is widened by the artificial Eustachian tube.

[0037] Since the purpose of setting the third opening is as described above, the position of the third opening is such that the artificial ear canal is located at or immediately above the eustachian canal when properly inserted into the patient's ear canal. It is preferable that Force the artificial ear canal into various patients with different lengths of eustachian tube at a depth appropriate for the patient's condition, with the third opening also at or just above the eustachian canal It is preferable to prepare artificial ear tubes having third openings at various positions within a range of 2 to 15 mm from the first opening in the distal end region. By doing so, for example, when the first opening exceeds the eustachian canal by 2 mm, the first opening force, for example, the one with the third opening at a position of 25 mm can be selected and used. When placing the first opening at a depth of 12 mm beyond the Eustachian canal, the first opening For example, an artificial ear canal with a third opening at 12-15 mm can be used. In the case of a type of artificial ear canal having a constricted portion adjacent to the distal end, a third opening may be provided in the constricted portion or a portion adjacent to the constricted portion (for example, on the rear side).

[0038] The implantable artificial ear canal of the present invention may be connected to the tubular body, apart from the second opening, on a tube wall within a range of 212 mm from the rear end, by communicating with the lumen of the tubular body. It may have a fourth opening that opens to the The fourth opening is intended to be located in the tympanic chamber when the artificial Eustachian tube is inserted into the patient's Eustachian tube, and to perform the ventilation and excretion functions as in the second lumen. Power S can. In particular, in the case where the second opening force S is simply opened in the axial direction at the posterior end of the artificial eustachian tube, a fourth opening provided in the tube wall in a deeper part of the tympanic cavity is further provided. This is beneficial in excreting exudate, if present, in the tympanic cavity more effectively.

[0039] The implantable artificial ear canal of the present invention may be of a uniform thickness for the method of fixing it using a projection at the rear end, but generally, it is generally used as a whole. It is more preferable that the portion closer to the front end is thinner than the portion closer to the rear end. In such a case, especially for patients with a narrow eustachian canal, it can be inserted while supporting a relatively thin distal end with a relatively thick rear end, which is convenient for insertion operation. There is. Also, if the patient has open ear canal and is to be inserted into the enlarged canal gorge to reduce its effective cross-sectional area, insert the one with a thickness appropriate for the tubal canal For this reason, for example, the portion from the rear end to the portion that is sandwiched between the eustachian canals may have a sufficiently large thickness, and the tip side may have a smaller diameter. In such a case, insertion into the canal canal is easy. However, in the case of a type of artificial Eustachian tube with a constriction adjacent to the distal end, it is the constriction that has the outer diameter of the thickness appropriate for the eustachian canal, and therefore, the portion located on the distal end side Has a somewhat larger outer diameter than this.

[0040] The implantable artificial ear tube of the present invention has a tubular body having the same outer diameter over its entire length, a tubular body having a rear end portion having a smaller outer diameter than a tip end portion, and Those having a smaller outer diameter than the rear end are included. When the distal end (or the rear end) of the tubular body has an outer diameter smaller than that of the rear end (or the front end), the outer diameter is gradually increased between the front end and the rear end. Alternatively, it may be changed continuously. [0041] For example, when the outer diameter of the tip portion is reduced as compared with the rear end portion, there is no particular limitation on how to do so, even if the outer diameter is continuously reduced, or a single tubular shape that is simply thinner than the rear end portion. The portion may be formed by the distal end portion, or a plurality of tubular portions may be connected in order to sequentially reduce the outer diameter. Similarly, when reducing the outer diameter of the rear end compared to the front end, whether the rear end forms a single tubular portion that is narrower than the front end, or by using a plurality of tubular portions. There may be a configuration in which the components whose diameters are sequentially reduced are connected.

[0042] When the tubular body is formed of a tubular portion having an outer diameter gradually decreasing from the rear end to the leading end, the difference between the outer diameters of adjacent tubular portions is usually 0.15 mm or more. In this case, it is preferable to bevel or round the shoulder portion where the outer diameter changes, in order to eliminate extra resistance at the time of insertion. The total length of the implantable ear canal is an item that is appropriately determined according to the length of the patient's ear canal and the length to be inserted into the cartilage ear canal. In the case of the type that has a projection or an enlarged outside diameter at the rear end, a force within the range of 15 to 45 mm can be set, usually for infants to adults. However, for example, an extra extension may be added to the front end or the rear end, and the operator may cut off the extra portion at the time of use (before or after insertion into the ear canal). In the case of such a configuration, when referring to the implantable ear canal of the present invention, when referring to the "tip" and "rear end", an extra length portion to be cut when used is excluded. The position after. If an extension is added to the posterior end, its outer diameter is arbitrary, but should not be larger than the outer diameter of the prosthetic ear canal (ie, the part from which the extension has been removed), so as not to unnecessarily enlarge the perforation of the eardrum. It is preferred to make it thinner or at least not more.

[0043] The lumen of the implantable artificial ear canal of the present invention preferably has a larger diameter at the rear end than at the front end. By doing so, when the exudate in the tympanic stomach enters the lumen at the posterior end, the exudate can be easily transferred downward and drained.

[0044] In the artificial eustachian tube of the present invention, which has a constricted portion for engaging with the eustachian canal, it is not necessary to provide a projection or an outer diameter enlarged portion at the rear end (although it is possible to provide it). However, the constriction provided in the tubular body is fixed to a predetermined position by engaging with the patient's ear canal. The degree of constriction and the length of the constriction in the longitudinal direction depend on the patient's physique and It may be adapted to the condition of the ear canal. Usually, the length of the constricted portion should be about 0.5 to 5 mm. The outer diameter of the constricted portion is usually preferably in the range of 3:11 to 9:11 with respect to the outer diameter of the portion adjacent to the tubular body. In general, if the outer diameter of the constricted part is 0.4-1.1 mm, it can be used for most patients. However, the outer diameter is not limited to this, and for patients with a larger inner diameter of the eustachian canal, it is necessary to prepare one with a constriction with a larger outer diameter.

[0045] The length of the artificial ear canal having the constricted portion may be the same as that of the other types. However, since there is no need to provide a protrusion or an outer diameter enlarged portion for fixing at the rear portion, it may be shorter than those types. The length from the center to the rear end of the neck may be, for example, 6 mm-22 mm (under 2 years old), 8-30 mm (2 years old and under 15 years old), 11-38 mm (15 years old and over), etc. . The constricted portion is a region at least 2 mm away from the tip of the tubular body, and the first opening force is preferably provided somewhere in the range of 12 mm or less. Is more preferably provided somewhere.

[0046] Insertion of the artificial ear canal of the type having a constricted portion is performed by pushing out the eustachian canal of the patient with a tip portion wider than the constricted portion. Due to the tissue pressure from the gorge, the Eustachian tube is fixed so as not to fall back and forth.

[0047] The artificial ear canal of the type having a constricted portion may further include a projection rising from the outer peripheral surface of the tubular body at a position adjacent to the constricted portion at the distal end. One or more (for example, two) such protrusions can be provided. Usually, they are preferably inclined toward the side of the constriction (that is, toward the rear end of the tubular body). The length of the projection is appropriate, but depending on the outer diameter of the tubular body (especially the outer diameter of the tip), for example, when the outer diameter is 0.8 to 1.1 mm, usually 0.2 to 0.2 It is preferred to be about 0.8 mm. These projections help to further secure the ear canal. Also, the projection may be formed by making an elongated triangular or arched cut in the tube wall of the tubular body and bending the tube wall at that portion and raising it outward. The opening formed thereafter serves as the above-mentioned third opening which is a drainage outlet for quickly excreting the exudate in the lumen to the nasal cavity side.

[0048] The material constituting the artificial ear canal of the present invention is biocompatible, that is, harmful to living organisms. It is possible to use a material which is unlikely to cause a foreign substance reaction or the like and which does not cause decomposition or deterioration in a living body. As such a material, a metal such as titanium can be used, but a flexible material is more preferable. As the flexible material, a material which is conventionally used for in vivo implantation and detention in a medical application can be appropriately used for producing an artificial ear canal. For example, examples of the flexible synthetic resin include, but are not limited to, butyl chloride, silicone, polyethylene, polypropylene, polypentene, polyurethane resin, and the like. It may be created using a biomaterial such as autologous cartilage. In addition, if a resin designed to increase the softness when heated to body temperature is used, it will maintain a moderate hardness that is easy to handle when purchased. This is more preferable because it is easy to design so that the possibility of giving

Example

[0049] Hereinafter, the present invention will be described more specifically with reference to typical examples, but it is not intended that the present invention be limited to the examples.

[Example 1]

FIG. 1 shows a side view of the implantable ear canal 1 according to the first embodiment. In the figure, an artificial ear canal 1 is a tubular tube with a uniform outer diameter of 28 mm in total length (for adults) whose lumen 2 is opened out of the tube at the front end 3 and the rear end 4 by the first opening and the second opening, respectively. It has a body 5 and a plurality of projections 6 provided on the rear end side of the tubular body 5, and is entirely formed of a polyurethane resin. The cross-sectional shape of the tubular body 5 is circular. This example has an outer diameter of about 2.5 mm and is intended for use in treating eustachian tube openness. In the figure, the tubular body 5 is straight, but as in other embodiments described later, a part can be curved by hand to conform to the shape of the ear canal. An opening 7 (fourth opening) communicating with the lumen 2 is provided on the tube wall at a position of about 20 mm from the front end 3 (about 8 mm from the rear end 4). The lumen 2 has a stenosis 8 in which the inner wall partially protrudes in an annular shape inward, and the inner diameter of the stenosis 8 is about 0.35 mm. In the artificial eustachian tube of this embodiment, the distal end portion of the Eustachian tube is inserted into the cartilage eustachian tube through the Eustachian canal for the purpose of closing and reducing the effective cross-sectional area of the eustachian canal. It was intended. The opening 7 is intended to be positioned in the tympanic chamber when the Eustachian tube 1 is inserted into the patient's Eustachian tube, and when the Eustachian tube 1 is so fixed, It can serve as a drain port to drain exudate into the nasal cavity. That is, the exudate in the tympanic cavity that has entered the lumen 2 through the opening 2 moves downward in the lumen 2 due to its own weight, and is discharged from the distal end 3 into the ear canal cartilage. The exudate can also enter the lumen 2 from the posterior end 4 and form a small force between the canal ridge with a flat cross section and the outer peripheral surface of the inserted artificial ear canal 1 The opening 7 may not be necessary because it can flow down the flow path to be drained, but if it is, the discharge of the exudate through the lumen 2 becomes easier.

[0051] The stenosis part 8 is a part corresponding to the ear canal, and its narrow inner diameter prevents air conduction of the self-voice to the tympanic chamber, and eliminates the patient's self-voiced hearing. However, when the inner diameter of the tubular body 5 is uniformly narrow, for example, when it is uniformly less than 0.8 mm, almost no air is transmitted to the middle ear of the subject's own voice. May be. The stenosis part 8 can also provide a stop site for stopping when the guide wire is hit when the guide wire is used to insert the artificial ear canal 1. In this embodiment, the lumen 4 is simply opened to the outside at the distal end 3, but the distal end may be closed and have an opening on the side as shown in an eighth embodiment described later. Further, in the present embodiment, a thick artificial Eustachian tube for open Eustachian tube disease is used. However, a thin artificial Eustachian tube used for stenosis of the Eustachian tube (obstruction of the Eustachian tube) is also used in the same manner as in this embodiment, except that the diameter of the Eustachian tube is captured. Can be configured.

The protrusion 6 is provided near the rear end of the artificial ear canal 1, and rises from the outer peripheral surface of the tubular body 5 while being inclined rearward at an angle of about 45 ° with respect to the axis of the tubular body 5. Is attached. In the figure, four protrusions 6 are provided, and three of them are seen above, below, and near the outer peripheral surface of the tubular body 5. The other one is provided at a position opposite to the tubular body 5 and symmetric with the protrusion on the near side. The length of the projection is 3-4 mm, and the width near the base is about lmm. One pair of protrusions rise from the position of 8 mm from the rear end 4 of the tubular body 5, and the other pair of protrusions rise from the position of 5 mm. In this example, dimensions are shown for adults. However, in order to use the same form for children (38 years old), for example, the overall length is about 20 mm, and the overall shape is similar. You must determine the dimensions of each part.

[0053] In the artificial ear canal 1 of the present embodiment, the projection 6 comes into contact with the inner wall of the tympanic chamber or the inner wall of the bone ear canal when the ear canal is stuck in the patient's ear canal. Fixed in position. After fixation, the artificial ear canal 1 eliminates self-voiced hearing and provides adequate ventilation. Function and excretion function can be maintained. As a result, the posterior end 4 of the artificial ear canal 1 is located deeper than the eardrum in the tympanic chamber or in the bony ear canal, so that the perforation of the patient's eardrum can be repaired and closed. After the eardrum is closed, the inside of the tympanic room is shut off from the direct outside air, so that the physiological environment of the tympanic room can be restored.

[Example 2]

FIG. 2 shows a side view of the implantable ear canal 11 of the second embodiment. In the figure, the artificial ear tube 11 has a tubular body 15 and four projections 16 provided at the rear end of the tubular body 15 and is formed of a polyurethane resin. In the present embodiment, the tubular body 15 has a tapered shape in which the rear end 14 becomes thinner as it becomes closer to the relatively thick front end 13. The shape of the cross section of the tubular body 15 is circular at all portions. One lumen passes from the front end 13 to the rear end 14 of the artificial ear canal 11, and the lumen is extravascular at the front end 13 and the rear end 14 by the first opening and the second opening, respectively. It is open to. In the present embodiment, the total length of the artificial ear canal 11 is about 27 mm, and an opening 17 (fourth opening) communicating with the lumen is formed in the tube wall at about 2 Omm from the tip 13 (about 7 mm from the rear end 14). Position. The tubular body 15 is provided with a constriction 18 having an inner diameter of 0.25 mm in the lumen at a position of 6 mm from the distal end 13, and communicates with the lumen at a position of about 9 to 10 mm from the distal end 13. Opening 19 (third opening) is provided. The opening 19 is provided so that when the artificial eustachian tube 1 is inserted into the patient's Eustachian tube such that the tip 13 of the Eustachian tube 13 exceeds the Eustachian canal by about several mm, it is located immediately above the Eustachian canal. This is to function as a drainage outlet from the lumen to the outside when the middle ear exudate enters the cavity. In other words, the exudate that has entered the lumen from the tympanic chamber flows out of the opening 19 immediately above the eustachian canal by the action of its own weight and the surface tension of the exudate outside the opening 19, and the outer peripheral surface of the tubular body 15 It flows down to the cartilage eustachian tube side and into the nasal cavity from the flat gap of the eustachian canal, which is slightly expanded. In this way, it is possible to assist the excretory action of the Eustachian tube in patients with Eustachian tube stenosis, and to surely solve the problem of exudate accumulation in the tympanic chamber. Therefore, it is preferable to provide the opening 19 in order to promote the excretion of exudate, but the introduction of the artificial eustachian tube itself slightly widens the flat eustachian canal, and works advantageously for exudate discharge. Therefore, opening 19 is not required.

[0055] The outer diameter of the vicinity of the front end 13 of the tubular body 15 is about 0.6 mm, and the inner diameter is about 0.4 mm. The outer diameter is about 1. lmm and the inner diameter is about 0.9 mm. At the position of the opening 19, the outer diameter is about 0.9 mm and the inner diameter is about 0.4 mm. The protrusion 16 has the same shape and size as the protrusion 6 of the first embodiment, and is provided at the same position.

[0056] The artificial ear canal 11 of the present embodiment has a curved portion near the distal end. This is so that the artificial ear canal 1 can be easily inserted into the ear canal through the eardrum. This is to approximate the curved shape of. Such a curvature may be given by the doctor in charge as appropriate during the operation, and thus may not necessarily be given in advance.

When the artificial ear canal 11 of the present embodiment is inserted into the patient's ear canal from the eardrum side, a guide wire having an appropriate diameter is inserted from the rear end 14 into the artificial ear canal 11 to reinforce the strength. It is preferred that Further, it is preferable to select the diameter of the guide wire so that the distal end does not protrude from the distal end 13 of the artificial ear tube 11. An artificial eustachian tube 11 reinforced with a guide wire, a perforation formed in the tympanic membrane is inserted into the patient's ear canal through the tympanic cavity, the ear canal of the eardrum, and the tip fits into the cartilage eustachian tube. It hits the inner wall of the tympanic membrane or the inner wall of the bony ear canal, whereby the artificial ear canal 11 is fixed in place. The guidewire is then removed, leaving only the prosthetic ear canal 11 in the patient's ear canal.

[Example 3]

FIG. 3 shows a side view of the implantable ear canal 21 of the third embodiment. In this embodiment, the outer diameter of the rear end 24 and the vicinity thereof is larger than that of the second embodiment, and the other points are the same as those of the artificial ear canal of the second embodiment. In the present embodiment, the large outer diameter (1.8 mm) near the rear end 24 narrows the gap between the outer peripheral surface of that portion and the inner wall of the tympanic cavity or the inner wall of the bony ear canal, thereby improving the fixing effect of the protrusion 26. In addition, it becomes easier to apply a small amount of bone putty to the narrow gap and to fix it more securely.

[Example 4]

FIG. 4 shows a side view of the implantable ear canal 31 of the fourth embodiment. In the present embodiment, the tubular body 35 has an outer diameter that is expanded at a part of the rear end portion by expanding the tubular body partially into a balloon shape (outer diameter of the maximum part is 2. Omm). Except for the enlarged-diameter portion, the shape of the present embodiment is the same as that of the third embodiment. By bulging to such a large outer diameter, in this embodiment, use of the bone putty is easier than in Embodiment 3. In this embodiment, The enlarged diameter portion is a force having a simple shape close to the surface of almost one spheroid, and one or more annular grooves or constrictions are provided on the enlarged diameter portion. It may be divided into

[Example 5]

FIG. 5 shows a side view of the implantable ear canal 41 of the fifth embodiment. This example is the same as the artificial ear canal of Example 4 except that no projection is provided. In this embodiment, the fixation of the artificial ear canal 41 is performed only by applying a bone putty to a narrow gap between the surface of the outer diameter enlarged portion at the rear end and the inner wall of the tympanic chamber or the inner wall of the bone canal. Be done.

[Specific Example of Projection]

FIGS. 6 to 11 show typical specific examples of the shape and arrangement of the projections in an implantable ear canal having a projection at the rear end, and are applied to the artificial ear canal of Examples 11 to 15. be able to. In the specific examples shown in FIGS. 6 and 7, the projections 6a and 6b have an elongated shape with a length of 3 to 4 mm integrally provided on the surface of the tubular body 5. These projections may be formed integrally with the tubular body 5 or may be fixed to the surface of the tubular body 5 by adhesion or fusion. The pair of projections 6a are located at positions symmetrical to each other with respect to the central axis of the tubular body 5, and the pair of projections 6b are provided at a position rotated by 90 ° around the central axis of the tubular body 5 with the pair of projections 6a. I have. In this way, the projections 6a and 6b can support and fix the tubular body 5 in various directions. In these specific examples, the pair of protrusions 6b are provided with a pair of protrusions 6b and a pair of protrusions 6a provided at a position slightly closer to the rear end 4 than the pair of protrusions 6a at the same longitudinal position. May be.

FIG. 8 shows a projection having a form different from those of FIGS. 6 and 7. In FIG. 8, the pair of protrusions 6a are located at positions symmetrical to each other with respect to the center axis of the tubular body 5, and the other pair of protrusions 6b are different from the pair of protrusions 6a by 90 ° around the center axis of the tubular body 5. It is provided at the rotated position and at a position slightly closer to the rear end 4 than the pair of protrusions 6a. Each projection is formed by making an elongated triangular shape (such as an isosceles triangle) or an arch-shaped cut in the tube wall of the tubular body 5 and bending the tube wall at that portion outward. 4mm, width of base is about 0.8mm. After the projections 6a and 6b have been formed in this way, the lumen is open outside the vessel at the openings 10a and 10b. These openings 10a and 10b are formed, for example, in the first embodiment. The same function as the opening 7 can be performed.

FIG. 9-11 is an end view showing a typical arrangement example of the projections when viewed from the rear end 4 side of the implantable ear canal. In FIG. 9, the pair of projections 6a (and the pair of projections 6b) are located symmetrically with respect to the center axis of the tubular body 5 as described with reference to FIG. It is slightly closer to the rear end 4 than the projection 6a.

In the example shown in FIG. 10, three projections 6c are evenly arranged along the outer periphery of the tubular body 5, and all the projections 6c are arranged from the rear end 4 of the tubular body 5 and the like. In the distance. In the example shown in FIG. 11, three projections 6c are evenly arranged along the outer periphery of the tubular body 5, and are located between the projections 6c and slightly near the rear end 4 of the tubular body 5. In the position, three protrusions 6d are evenly arranged.

Example 6

FIG. 12 is a side view of the implantable ear canal 51 of the sixth embodiment. In this embodiment, the tubular body is composed of a relatively thin tube 55f on the tip 53 side and a relatively thick tube 55s forming a shaft, and has a total length of about 28 mm (for adults). The pipe 55f has a length of about 7 mm, an outer diameter of about 0.6 mm, and an inner diameter of about 0.4 mm, and the pipe 55s has an outer diameter of about 0.9 mm and an inner diameter of about 0.7 mm near the pipe 55f. In the vicinity of the rear end 54, it has about 1.1 mm and an inner diameter of about 0.9 mm. Both the tube 55f and the tube 55s are made of polyurethane resin, and in this embodiment, a part of the tube 55f is fitted into the lumen of the tube _55s , and is fused and integrated at the fitted portion. At a position about 8 mm from the distal end 53, a stenosis part 58 with an inner diameter of 0.25 mm is opened in the lumen, an opening 57 is opened at a position about 21 mm from the distal end 53 force (a rear end 54 force is about 6 mm), and an opening 57 is opened at about 910 mm. Mouth 59 power is provided for each. The constriction 58 and the openings 57 and 59 correspond to the constriction 18 and the openings 17 and 19 in the second embodiment.

Example 7

FIG. 13 is a side view of the implantable artificial ear canal 61 of the seventh embodiment. In the present embodiment, the tubular body is composed of a relatively thin front-end tube 65f, a middle-diameter middle tube 65m, and a thickest rear-end tube 65s, and has a total length of about 28 mm. (For adults). The pipe 65f has a length of about 7mm, an outer diameter of about 0.6mm, and an inner diameter of about 0.4mm, and the pipe 65m has a length of about 4mm, an outer diameter of about 0.9mm, an inner diameter of about 0.7mm, and a pipe 65s. , Length about 17mm, outer diameter about 1.lmm, It has an inner diameter of about 0.9mm. These three tubes are made of polyurethane resin, and are integrated by fitting a part of the ends to each other and fusing them. Other configurations are the same as in the seventh embodiment.

Example 8

FIG. 14 is a side view of the implantable ear canal 71 of the eighth embodiment. This embodiment is the same as the configuration of the seventh embodiment except that the tip 73 is closed and an opening 80 (first opening) is provided in the tube wall on the side. The opening 80 communicates with the lumen, and performs the same function as the opening formed in the distal end 63 of the artificial ear canal 61 of the seventh embodiment. However, in the present embodiment, since the distal end 73 of the artificial ear tube 71 is closed, when the guide wire is passed through the lumen from the rear end 74 when inserting the artificial ear tube into the patient, the guide wire is not connected to the ear tube. After passing through the gorge, the guidewire does not pass through beyond the tip 73, and it becomes easier to remove only the guidewire after the artificial eustachian tube is inserted, which contributes to simplification of the operation. In the figure, a portion E indicated by a broken line is a tubular extension portion that can be added to the rear end of the artificial ear canal, and is made of, for example, the same material as the human ear canal, and is formed integrally with the artificial ear canal. * Fused. Such an extension can be added to the artificial ear canal of any of the embodiments, and can be cut off as an unnecessary part when the artificial ear canal is loaded into the tympanic chamber.

Example 9

FIG. 15 is a side view of an implantable ear canal 81 of the ninth embodiment. This example is the same as the artificial ear canal of Example 7 except for the structure of the mounting portion of the projection 86. FIG. 16 is an enlarged view showing a mounting portion of the projection of this embodiment. As is clear from these figures, the protrusions 86a and 86b are formed by making an elongated triangular or arched notch in the wall of the short pipe 90 (length: 12 mm) covered by the pipe 85f, The wall is bent up and raised outwards, each 3-4 mm in length, and the width of the root is about 0.8 mm. The short pipe 90 is partly fused and integrated with the pipe 85s. After raising the projections 86a and 86b outward, the outer wall of the tube 85s is exposed.

[Example 10]

FIG. 17 shows a mounting portion of the projection 96 of the implantable ear canal 91 of Example 10. It is an enlarged view. In the present embodiment, the short tube 100 corresponds to the short tube 90 of the ninth embodiment, and has the same thickness as the tube 95 s, but the diameter is enlarged by expanding the slit 101 inserted in the axial direction. , Over the tube 95s. The short pipe 100 and the pipe 95s are fused and integrated at least in part. In other respects, the present embodiment is the same as Embodiment 9.

(Example 11)

FIG. 18 is a side view of the implantable artificial ear canal 111 of the eleventh embodiment, and FIG. 19 is a perspective view of the vicinity of the distal end portion and the constricted portion 120. In these figures, the tubular body 115 has a total length of about 29 mm and has a constricted portion 120 in the middle. Although the constricted portion 120 and the portions before and after it are connected by welding, any other method of constricting portion may be formed. In this embodiment, the length up to the distal end constriction 120 is about 5 mm, and the length of the constriction 120 itself is about 1.5 mm. The tubular body 115 is composed of a relatively thick portion having a length of about 11 mm near the rear end 114 and a relatively thin portion near the front end. The former has an outer diameter of 1.3 mm and the latter has an outer diameter of 1. lmm. The outer diameter of the constricted part 120 is 0.7 mm at the thinnest part, and the inner diameter of the constricted part is about 0.45 mm at the thinnest part. The central force of the constricted portion 120 is approximately 23 mm in length to the rear end. At a position adjacent to the constricted portion 120 at the distal end, a pair of protrusions 116 rise up from the opposite sides of the side surface of the tubular body 115 in a direction toward the rear end. The pair of projections 116 is similar to that shown in FIG. 8, in which a triangular cut is made in the tube wall of the constricted portion 120, and the tube wall at that portion is bent and raised outward. Has a pair of openings 119 in the wall of the tube that communicate with the lumen. However, the opening 119 is formed for convenience of forming the projection 116, and the projection 116 may be provided by any other appropriate method that does not cause unnecessary opening. The length of the projection 116 is about 0.6 mm, and the angle of inclination is about 45 °. The tubular body 115 has an axially open lumen at the rear end 114 (second opening), but is closed at the distal end 113 (blind end), and instead has a distal force of about 2.5 mm. An opening 121 (first opening) is provided in the pipe wall at the position where the pipe 121 is located. The projections 116 provided in the present embodiment may be fixed only by the constricted portion 120 by omitting the force acting to strengthen the fixing. In addition, an opening (fourth opening) may be provided in the tube wall at an appropriate position near the rear end 114 so that the exudate in the tympanic chamber can be quickly guided into the lumen. The present embodiment is also manufactured in various sizes according to the physique of the patient and the variety of the shape of the Eustachian tube. In addition, the constricted part 120 An opening (third opening) may be provided in the tube wall at a position adjacent to the rear end side of the tube.

[Clinical study]

A part of the results of a clinical trial in which the artificial ear canal of the type of Example 1 of the present invention was treated in a patient is described below.

(Test method)

Eustachian tube function test: The Eustachian tube function test was performed by the pressurization / decompression method and the acoustic Eustachian tube method. In the test by the pressurization and decompression method, air pressure is applied at a constant speed from the ear canal side to the ear canal via the eardrum perforation, and the pressure at which the ear canal spontaneously opens (referred to as passive opening pressure or reverse ventilation pressure) is examined. There are static tests and dynamic tests in which a constant positive or negative pressure is applied to the middle ear from the ear canal side and the degree to which the Eustachian tube is opened (active dilatation) by swallowing movement. According to the pressurization and decompression method, in the case of a healthy Eustachian tube, even if the pressure in the tympanic chamber is increased from the outer ear side, the Eustachian tube is opened by the swallowing movement, and a rapid recovery from decompression is seen. Even if the applied air pressure is gradually increased, the eustachian tube is passively expanded and opened (passive expansion) when the air pressure reaches a certain level, and the air flows out. . In Eustachian tube stenosis, in contrast, the eustachian tube remains closed during the swallowing movement, so that the air pressure on the tympanic side does not decrease even after repeated swallowing, and the air pressure in the tympanic chamber is quite high. Otherwise, passive expansion of the Eustachian tube will not occur. The average passive passive pressure is about 355 daPa in the normal ear, and it is considered normal if the standard deviation is within X2.If it exceeds 545 daPa, it can be judged as abnormal.

[0073] An eustachian tube test device ET-1 000 manufactured by Nagashima Medical Instruments Co., Ltd. was used for the test by the pressurization and decompression method (conceptually shown in FIG. 20). When the channel of the device is loaded with air pressure (positive or negative pressure) from the outer ear side of the perforated eardrum and the eustachian tube is opened (by swallowing or The pressure change was measured by the pressure transducer 141, amplified by the amplifier 142, recorded in the recorder 143, and evaluated.

[0074] The acoustic Eustachian tube method examines the opening and closing of the Eustachian tube by projecting sound from a load sound source into the nasal cavity and monitoring the change in sound pressure during swallowing using a microphone attached to the external auditory meatus. It is a way to If the Eustachian tube is enlarged during swallowing, the sound in the nasal cavity is conducted through the Eustachian tube Because the sound reaches the external ear, the presence and degree of stenosis of the Eustachian canal can be evaluated based on the change in sound pressure captured by the microphone on the ear canal side.

[0075] For the examination by the acoustic Eustachian tube method, an Eustachian tube function examination device ET-1 000 manufactured by Nagashima Medical Instruments Co., Ltd. was used (conceptually shown in Fig. 21). The channel of the device was adjusted to the acoustic auditory canal function test, and the swallowing movement and the sound pressure of the external auditory meatus were simultaneously monitored to evaluate whether or not the ear canal was opened during swallowing.

(Case 1) A 24-year-old male patient. Right eustachian tube openness. In the preoperative eustachian tube function test, the passive diastolic pressure at the time of back ventilation from the middle ear to the pharynx by the decompression method is about 150 daPa, which is clear from the normal value (355 ± 190 daPa: mean ± 2SD) Was low. For this patient, a protrusion (3 mm long, root) with an outer diameter of 1.3 mm and a length of 28 mm, fitted at the rear end according to Example 10 (see Figure 17) An artificial ear tube made of a polyurethane resin having a width of 0.9 mm and a thickness of 0.1 mm) at about 5 mm from the rear end in three directions according to FIG. 10 was prepared. An incision was made in the patient's eardrum, and an artificial eustachian tube was inserted from the eardrum side so that the tip reached a position several mm beyond the eustachian canal, and the posterior end was positioned deeper than the eardrum. In this state, the artificial Eustachian tube was fixed in position with the protrusion at the rear end pushing the tympanic wall. Immediately after the operation, the Eustachian tube narrowed slightly to around 550 daPa, but when the inflammatory symptoms subsided on the third day after the operation, the passive open pressure of the Eustachian tube during back ventilation from the middle ear to the pharynx became The perforation of the tympanic membrane was closed with vesquitin because it was almost normalized to 41 OdaPa. No subjective or objective morbid complaints or findings have been reported after eardrum closure.

(Case 2) A 63-year-old male patient. Chronic adhesive otitis media with persistent otorrhea due to right eustachian tube obstruction. For this patient, the outer diameter at the distal end is smaller (outer diameter about 0.7 mm), and the outer diameter increases as it approaches the posterior end (maximum outer diameter about 1.3 mm at a position with a posterior force of about 4 mm). An artificial ear canal of the type of Example 5 (FIG. 5) having a total length of 28 mm was prepared, in which only about 4 mm was thinner again (outer diameter about 1.1 mm). Under general anesthesia, an incision is made in the posterior part of the right auricle, the posterior wall of the ear canal is dissected, the eardrum is detached from the posterior part of the ear canal, and microscopic surgery is performed at a position where the supra-epithelial cavity and the ear canal canal are directly visible. Continued. In this state, the artificial Eustachian tube is inserted into the Eustachian tube from the Eustachian tube mouth, and the inflated portion over the length of about 5 mm of the Eustachian tube locus and the following small diameter portion of about 4 mm protrude. did. Fill the area around the small diameter part roughly with bone putty Fixed the artificial ear canal in that position. A portion of the temporal fascia was collected and reinforced as a new eardrum. Immediately after the operation, otorrhea, which had not stopped before, disappeared, and otitis media on the right side improved completely. Even with subjective eustachian tube insufflation by a catheter, the eustachian tube expanded, and the sound of insufflation began to be heard.

(Case 3) A 34-year-old female patient. Approximately 1 year and 6 months ago, right ear obstruction, hearing loss, and tinnitus have been reported, and as anti-allergic agents, surface active agents, and macrolide antibiotics, similar to exudative otitis media, as right Eustachian tube stenosis and right Eustachian tube obstruction Treatment of the eardrum, insertion of the tympanic membrane tube, etc., Eustachian tube function test: Etal opening of the Eustachian tube during TTAG valsalva ventilation 550 daPa or more, sound pressure rise negative by acoustic method, reverse from middle ear to pharynx The Eustachian tube opening pressure at the time of ventilation was 550 daPa, and both showed signs of Eustachian tube obstruction or stenosis, and were progressing without improvement. The artificial ear canal shown in Example 11 (having the same dimensions) was prepared for this patient. Under local anesthesia, an incision was made in the anterior and upper part of the right eardrum, and the artificial ear canal was pushed into the patient's ear canal so that the posterior end of the eardrum was about 30 mm deep. The insertion of the artificial ear canal was performed by pushing with a guide wire passed from the opening at the rear end of the artificial ear canal to the distal end (blind end) into the lumen. Next, remove only the guidewire and confirm that the posterior end of the artificial ear canal fits inside the tympanic membrane and inside the eardrum, and that the artificial ear canal is fixed at that position. Was confirmed by picking the rear end with forceps. Immediately after the operation, right ear obstruction and hearing loss improved, and tinnitus changed from a loud noise like cicada to a pulsating tinnitus like blood flow, and the symptoms improved. Objectively, the Eustachian tube function test decreased the Eustachian tube open pressure and the acoustic method clearly improved from negative to positive preoperatively.

Industrial applicability

The implantable Eustachian tube of the present invention is used for treating Eustachian tube stenosis (Eustachian tube obstruction), Eustachian tube openness, Eustachian tube insufficiency and Eustachian tube dysfunction including floppy tube. That can be S.

Claims

The scope of the claims

[1] In a human ear canal comprising a tubular body having a distal end positioned through the eustachian canal and into the cartilage ear canal and a posterior end positioned within the tympanic cavity or the bone canal. An artificial ear canal to be implanted,

The distal end and the rear end of the tubular body are communicated by a lumen,

In the distal region, the lumen opens out of the lumen through the first opening;

(a) at the rear end, at least partially having an outer diameter enlarged portion having an upper limit of 8 mm or less and / or having a projection rising from the outer peripheral surface of the tubular body, and / or

(b) A constriction for engaging with the Eustachian gorge is provided in an area at least 2 mm from the tip and within the first opening force of 12 mm.

An implantable artificial ear canal, characterized in that:

[2] The implantable artificial ear tube according to claim 1, wherein the projections include at least two projections that also have a force rising at least at two points of the tubular body.

[3] The implantable artificial ear tube according to claim 1 or 2, wherein the tip of the projection reaches a distance of 1.55 mm from the central axis of the tubular body.

[4] The filling according to any one of claims 1 to 3, wherein the lumen has a diameter of 0.20 mm or more, and has at least a region not exceeding 0.8 mm. Type artificial ear canal.

[5] The implantable ear canal according to any one of [1] to [4], wherein the outer diameter of the distal end portion is in the range of 0.35-3. Omm.

[6] The implantable artificial ear tube according to any one of claims 1 to 5, wherein an outer diameter of the distal end portion is 0.35 to 1.7 mm.

[7] The implantable artificial ear tube according to any one of claims 1 to 6, wherein the projection is inclined toward a rear end of the tubular body.

[8] The implantable artificial ear tube according to any one of claims 1 to 7, wherein the projection has a length of 116 mm.

[9] The tubular body communicates with the lumen within a range of 2 to 15 mm from the first opening, and extends outside the vessel. 9. The implantable ear canal according to claim 1, having an open third opening.

[10] The implantable artificial ear tube according to any one of claims 1 to 9, wherein the distal end has a smaller outer diameter than the rear end of the tubular body.

[11] The implantable artificial ear tube according to any one of claims 1 to 10, wherein the total length is 15 45 mm.

12. The tubular body according to any one of claims 1 to 11, wherein the tubular body has, within a range of 2 to 12 mm from a rear end thereof, a fourth opening communicating with the lumen and opening outside the tube. The implantable ear canal.

13. The artificial ear canal according to claim 1, having the feature (b), wherein the length of the constricted portion along the longitudinal direction of the tubular body is 0.5 to 5 mm. tube.

[14] The artificial ear canal according to any one of claims 1 to 13 having the characteristic (b), wherein the constricted portion has a diameter of 3: 119 with respect to an outer diameter of a portion of the tubular body adjacent to the constricted portion. : Artificial ear canal having an outer diameter in the range of 11.

[15] The artificial ear canal according to any one of claims 1 to 14, which has the feature (b), further comprising a protrusion rising from an outer peripheral surface of the tubular body adjacent to a distal end side of the constricted portion. , Artificial ear canal.

[16] The implantable artificial ear tube according to any one of claims 1 to 15, wherein the artificial ear tube is formed of a flexible material.