WO2006118072A1 - Artificial auditory canal - Google Patents

Abstract

An artificial auditory canal to be inserted and placed in the auditory canal of a patient for normalizing the air flow and the exudate flow between the tympanum side and the nasal cavity side, which can be completely embedded and shows an elevated discharge efficiency of the exudate in the tympanum into the nasal cavity side. This artificial auditory canal, which has a front end, a back end and a lumen and the front end of which is introduced from the auditory canal in the bony part side to the auditory canal in the cartilaginous part side via the narrow part of the auditory canal so that the artificial auditory canal is held on the narrow part of the auditory canal and thus retained in the auditory canal, characterized in that it has a plural number of projections dispersed around the outer periphery on the peripheral face at least in the part to be held on the narrow part of the auditory canal and, in this part and/or a part in the front end side of the artificial auditory canal, the lumen is open outward from at least one opening in the front end side while the lumen is open outward from at least one opening in the back end side located posterior to the above-described part.

Description

 Specification

 Artificial ear canal

 Technical field

 [0001] The present invention relates to an artificial ear canal that can restore the function of a patient's ear canal by being embedded in the ear canal of a patient.

 Background art

 [0002] The ear includes an outer ear, a middle ear, and an inner ear. The outer ear and the middle ear are separated by the eardrum located at the inner edge of the ear canal. The middle ear is the tympanic chamber (middle ear cavity), which is the space that houses the ear ossicles (Tuchi, Kinuta and Abumi bones) that connect the tympanic membrane and the vestibular window (which leads to the vestibule of the inner ear), and the pharynx with extended tympanic force The ear canal is open to the The eustachian tube begins in the tympanic vestibule (the tympanic ear canal) and extends diagonally from the upper rear outer side to the lower front inner side and opens in the pharyngeal side wall (the ear canal pharyngeal mouth). The eustachian tube is approximately 33mm long, with the upper 1Z3 passing through the temporal bone and the lower 2Z3 encased in cartilage. The bone ear canal passes through the narrowed tympanic ear canal and then gradually narrows and becomes the thinnest at the cartilage entrance (the canal area).

) Normally closed at this position. Below the eustachian tube, the eustachian tube gradually thickens and opens into the pharyngeal mouth in a rapper shape. One of the functions of the eustachian tube is the ventilation function. This is because the lower wall of the cartilage part is pulled downward by the contraction of the palatal levee muscle during swallowing, the lumen of the canal is temporarily opened, and air flows into the pharyngeal tympanum It is divided into active ones and passive ones that passively ventilate as the external pressure changes. In healthy ears, the intratympanic pressure is kept equal to the external pressure due to the ventilatory function of the eustachian tube, especially the active ventilation function. The eustachian tube also has the function of excreting middle ear secretions into the pharynx. The state in which these functions are impaired, i.e., ear canal dysfunction, include ear canal stenosis (ear canal obstruction), ear canal opening, ear canal insufficiency, exudative otitis media, cholesteatic otitis media, Adhesive otitis media and the like can be mentioned.

[0003] Eustachian stenosis is a condition in which the expansion of the eustachian tube, which is the result of swallowing, etc., is impaired for some reason, and ventilation of the middle ear through the eustachian tube is impaired. The cause of this is due to organic stenosis of the eustachian tube due to inflammation of the nasopharynx, etc. There is functional stenosis due to dysfunction. When ventral ventilation of the middle ear is obstructed due to the stenosis of the ear canal, oxygen in the tympanic chamber is absorbed from the surrounding mucosa, resulting in negative pressure in the tympanic chamber and infiltration of the tympanic membrane. As a result, symptoms such as ear-closed feeling, hearing loss, and hearing loss are caused. If tubal stenosis persists, it may shift to exudative otitis media. This is a disease in which exudate leaks into the middle ear cavity as a result of persistent negative pressure in the tympanic chamber, which fills the tympanic chamber with exudate and causes hearing loss and ear obstruction, as well as recurrent acute otitis media. It becomes easy to suffer from. In addition, if the tympanic chamber is placed in a chronic and irreversible negative pressure state, it may occur in adhesive otitis media, an extremely refractory disease in which the tympanic membrane adheres to the middle ear wall, or in the mucous membrane of the middle ear cavity, which is not essentially epithelial It also causes cholesteaten otitis media, a disease in which the keratinized squamous epithelium of the tympanic membrane proliferates and destroys the surrounding bone in the process.

For treatment of Eustachian tube stenosis, V and so-called Eustachian tube ventilation therapy is frequently used. Other treatments include steroid hormone injection into the ear canal from the pharyngeal side or tympanic chamber side, and sterol hormone injection submucosally around the ear canal pharyngeal mouth. It has not been established. In conservative treatment by medication, anti-inflammatory enzyme preparations are administered systemically with antiallergic drugs and nasal drops of steroids, but they require long-term medication and are effective in patients with moderate or higher severity. You can't get enough! / There are many cases! In cases where drug therapy is not effective, tympanic tube placement is also performed to ensure ventricular ventilation. The eardrum tube is a tube that can be fitted into a perforation provided in the eardrum, and various sizes and shapes are commercially available. One of the most commonly used is a central tube with a length of about 3mm. However, depending on the tympanic membrane tube, the tympanic tube can be ventilated. The ear canal stenosis itself is not sufficiently improved, and the ventilation and excretion through the ear canal are not necessarily restored. In addition, the eardrum tube naturally falls off within a few months to a year with the repair of the perforation of the eardrum. If ear canal stenosis has not been improved, the eardrum tube must be re-applied to ensure ventilation. Yuve detention is also required. Recently, a treatment method has been developed to cauterize the mucous membrane in the ear canal and pharyngeal mouth with a laser (carbon dioxide laser, KTP laser) for cases that resist drug treatment. While cautiously, cauterize the inner part near the canal It is essential to master sufficient anatomical knowledge and advanced surgical techniques in order to perform ablation of the canal, which has many unclear points about the effects on the surrounding tissue. It will come to be.

 [0005] In addition, eustachian tube is a condition in which the eustachian tube is always open. As a subjective symptom of a patient, self-hearing is caused by the fact that his / her voice reaches the middle ear via the eustachian tube. Some people complain of dizziness, such as hearing their own breathing sounds and feeling of ear closure. The patient's tympanic membrane is normal but is observed to move back and forth with breathing. Causes of eustachian tube include atrophy of the nasal mucosa due to aging and neurological diseases, atrophy of the peritubular mucosa due to weight loss, and scarring after adenoid surgery, but the cause is unknown.

 [0006] Pharmacotherapy for Eustachian tube disease includes the Bezold method in which a mixed powder of boric acid and salicylic acid is sprayed into the ear canal with an ear canal catheter, injection of gelatin sponge solution into the ear canal lumen, etc. Surgical therapy includes injection of liquid silicone, cauterization of the mucosa of the ear, movement of the palatal scapularis, injection of collagen or cartilage around the ear canal, and collagen injection. However, there was a problem that long-term continuous treatment was required and the surgical treatment was not effective enough. In addition, as a device for treatment of eustachian tube and ureteral insufficiency, a flattened eustachian pin with a taper that is placed in the middle ear canal lumen from the eardrum about 5 to 15 mm deep is proposed. (See Patent Document 1), however, this works to block the cross section of the ear canal and is not applicable to ear canal stenosis.

 [0007] In addition, a so-called floppy tube has recently been attracting attention as a function of the eustachian tube function. A floppy tube is an ear canal that is easy to block and easily open, and when it is swallowed, the ear canal is opened, resulting in self-hearing and a feeling of ear closure. In order to resolve these discomforts, patients often become unconsciously sniffing (this causes negative pressure in the tympanic chamber and closes the ear canal), but this becomes habitual and chronic and irreversible. As described above in relation to ear canal stenosis, it can also cause exudative otitis media, adhesive otitis media, and cholesteatoma otitis media when placed under negative pressure.

[0008] As described above, abnormalities of the eustachian tube function cause various diseases of the middle ear. However, it is possible to effectively and simply use a floppy tube that causes both ocular canal stenosis, eustachian tube opening, or both occlusion and opening. Treatment of adhesive otitis media, adhesion of tympanic membrane after exudative otitis media surgery There is a need for reliable treatment methods that can be used to prevent pearl seeds and prevent recurrence of pearl species.

 [0009] For this purpose, the present inventor has previously developed a tube having a predetermined shape having an opening for ventilation on the tube wall. Then, this is inserted into the tympanic side through the eardrum and inserted into the ear canal part, and the tip is located in the cartilage part of the ear canal, while the opening of the tube wall is located in the eardrum and the rear end of the tube is attached to the eardrum. By fixing it through the tube, the nasal cavity and the tympanic chamber are communicated with the ear canal stenosis (tubal obstruction), and the ventilation function and excretion function through the ear canal are restored to a physiologically close state. What can be done, and at least a part of the cross-sectional area of the tubal canal that is overspread is closed and adequate communication between the nasal cavity and the tympanic chamber is ensured through the tube lumen. I found out that I can do it. Focusing on the fact that such a tube is extremely effective in the treatment of ear canal dysfunction and can be an “artificial ear canal”, based on this, an artificial ear canal consisting of a tube of a predetermined form was developed. (International application date October 28, 2004: Patent Document 2).

 [0010] Further, the present inventor does not need to fix the rear end to the eardrum, and thus enables the perforation of the eardrum to be closed, and has the same therapeutic effect while restoring the intratympanic environment closer to a more physiological state. Two types of artificial ear canals that can be completely implanted have been developed, and patent applications and international applications were also filed for them (patent document 3, Nov. 2004, Patent Document 3, International filing date February 21, 2005 Patent document 4). Of these fully-embedded artificial ear canals, the former has a multi-stage annular projection at the part to be sandwiched between the canal canals, and the latter has a structure that fixes itself to the inner chamber wall at the rear end. Or a constricted part (or a protrusion in front of the constricted part) is provided at a portion to be sandwiched between the canal part. Each of these fully implantable artificial eustachian tubes has a smooth outer periphery such as a circle or an ellipse in the cross-section at the portion sandwiched between the canal canal portions. Contact is in close contact with the surface.

 Patent Document 1: JP 2002-224157

 Patent Document 2: PCT / JP2004 / 015995

 Patent Document 3: PCT / JP2005 / 002724

Patent Document 4: Column 2004-323016 Disclosure of the invention

 Problems to be solved by the invention

 [0011] In the above background, the present invention relates to a fully implantable type artificial ear canal that is inserted into a patient's ear canal to normalize the flow of air and exudate between the tympanic chamber side and the nasal cavity side. An object of the present invention is to provide a human ear canal that can further increase the efficiency of excretion of exudate in the tympanic chamber to the nasal cavity side.

 Means for solving the problem

 [0012] The present inventor has a smooth outer periphery such as a circle or an ellipse in a cross section at a portion sandwiched between the canal isthmus in the above-described fully-embedded artificial ear canal. We focused on the point of contact with the inner wall of the strait in the form of close contact between the surfaces. That is, exudate does not flow along the outer periphery of the artificial ear canal at the close contact area between the inner wall of the ear canal and the outer peripheral surface of the artificial ear canal. In contrast, if the flow path in the front-rear direction is secured around the prosthetic canal while maintaining the function of maintaining the position of the prosthetic canal in the region sandwiched between the canal isthmus, It will be possible to further promote the outflow of exudate in an implantable type artificial ear canal. The present inventor is able to achieve this by securing a flow path in the front-rear direction between the protrusions by providing a plurality of protrusions dispersed around the outer periphery at the portion sandwiched between the canal isthmus. As a result, the present invention was completed. That is, the present invention provides the following.

 [0013] (1) A patient having a distal end, a rear end, and a lumen, and facing the tip of the cartilage part through the canal from the bony part of the canal, and being sandwiched by the canal part. An artificial eustachian tube to be inserted into the ear canal,

 At least at the part to be sandwiched between the ear canal part, the outer peripheral surface is provided with a plurality of protrusions dispersed around the outer periphery,

 The lumen is open to the outside through at least one distal-side opening at the site of the artificial ear canal and at or near the distal end of Z.

Behind the site, the lumen is open to the outside through at least one posterior opening An artificial eustachian tube characterized by that.

 (2) The artificial ear canal according to the above 1, wherein a plurality of protrusions are further dispersed on the outer peripheral surface in the longitudinal direction of the artificial ear canal at least at a portion sandwiched between the canal canal portions.

(3) The plurality of protrusions provided around the outer periphery and dispersed in the longitudinal direction are such that the height of their tips as a whole decreases toward the tip side of the artificial ear canal. The artificial ear canal of 2 above.

 (Four)

 4. The artificial ear canal according to any one of 1 to 3 above, wherein the protrusion is a warped protrusion.

 (5) The projecting portion is a projecting ridge extending in the longitudinal direction of the artificial ear canal, and rises while increasing in height toward the rear at the distal end side thereof. Any one of the artificial eustachian tubes.

 (6) The protrusions described in 1 to 3 above, wherein the protrusion is a protrusion extending in the longitudinal direction of the artificial ear canal, and the protrusion has a plurality of cutouts on the upper edge in a lateral cross section thereof. Any artificial eustachian tube.

 (7) The artificial eustachian tube as described in 6 above, wherein the protrusion has a triangular blade shape in which a plurality of ridges are formed in a lateral cross section.

 (8) The artificial eustachian tube according to 6 or 7 above, wherein the protruding ridge is directed rearward on the rear end side to reduce the height.

 (9) The artificial ear canal according to any one of 1 to 3 above, wherein the protruding portion is a rod-like protrusion protruding from the outer peripheral surface force of the artificial ear canal.

 (10) The artificial eustachian tube according to any one of 1 to 9 above, wherein a portion to be sandwiched between the eustachian tube portions is such that the tip force of the artificial eustachian tube is also within 20 mm.

 (11) The protrusion is provided over a range of 5 mm or more in the longitudinal direction of the artificial ear canal! Any one of the above mentioned artificial ear canals.

 (12) The artificial ear canal according to any one of 1 to 11 above, wherein the protrusion is provided on the rear side from the position of the distal force 4.5 mm of the artificial ear canal, V.

(13) Any one of 1 to 12 above, wherein the tip of the protrusion is located within a radius of 0.3 to 3. Omm from the central axis of the artificial ear canal Artificial ear canal.

 (14) An annular constriction portion is included on the distal side of the artificial ear canal in the rear side from a position 4.5 mm from the distal end of the artificial ear canal and adjacent to the projecting portion provided in a distributed manner. The artificial eustachian tube of any one of 1 to 13.

 (15) providing a flow path having at least an inner diameter of 0.2 mm or more through which the distal end opening, the lumen, and the rear opening communicate with the inside and outside of the artificial ear canal; The artificial ear canal according to any one of 1 to 14 above, wherein the flow path has a portion having an inner diameter of 0.9 mm or less.

 (16) The artificial canal of any one of 1 to 15 above, wherein the rear opening is open on the side wall of the artificial canal.

 (17) The above 16 artificial ear canal, wherein the rear opening is also opened at the rear end of the artificial ear canal.

(18) The artificial ear canal according to any one of 1 to 17 above, having an overall length of 22 mm or more.

 (19) The artificial ear canal according to any one of 1 to 18 above, which is made of flexible rosin.

 The invention's effect

 [0014] According to the present invention configured as described above, since a flow in the front-rear direction can be ensured at the contact portion between the artificial ear canal and the ear canal portion at the portion sandwiched between the ear canal portions, the tube of the artificial ear canal Together with the flow path provided by the cavity, it is possible to further promote the discharge of exudate in the tympanic chamber to the nasal cavity side. Therefore, effective and simple treatment of floppy tubes that cause both ear canal stenosis, ear canal openness or both obstruction and openness, treatment of adhesive otitis media, prevention of tympanic membrane adhesion after surgery for exudative otitis media, and pearl species Provided is an artificial ear canal that can be used to prevent recurrence of the exudate and has a further enhanced exudate excretion function.

 Brief Description of Drawings

[0015] [FIG. 1] A plan view of the artificial eustachian tube of Example 1 as seen from slightly behind.

 FIG. 2 is a plan view of the artificial eustachian tube of Example 2 as seen from slightly behind.

 [Fig. 3] Plan view of the artificial eustachian tube of Example 3 as seen from slightly behind.

 [Fig. 4] Plan view of the artificial ear canal of Example 4 as seen from the rear.

FIG. 5 is a plan view of the artificial eustachian tube of Example 5 as seen from slightly behind. [Fig. 6] Plan view of the artificial eustachian tube of Example 6 as seen from slightly behind.

 [Fig.7] Conceptual diagram showing the principle of eustachian tube function testing by the pressurized and reduced pressure method

 [Fig.8] Conceptual diagram showing the principle of acoustic ear canal function testing

 [Fig. 9] Conceptual diagram showing the principle of eustachian catheter air permeability test

 FIG. 10 is a chart showing the results of preoperative acoustic eustachian examination in case 1

 [Fig. 11] Chart showing the results of preoperative Valsalva ventilation test in Case 1

[Fig. 12] Chart showing the results of preoperative deep nasal breathing in case 1

 FIG. 13 is a chart showing the results of a pre-pressure pressurization test in case 1

 FIG. 14 is a chart showing the results of postoperative acoustic eustachian examination in case 1

 [Fig. 15] Chart showing test results of postoperative eustachian catheter ventilation in case 1 Explanation of symbols

 [0016] 1 = tubular body, 2 = small diameter part, 3 = tip, 4 = opening, 5, 5 '= opening, 6 = opening, 7 = protrusion, 8

 = Tip side shaft, 9 = constricted part, 11 = tubular body, 12 = small diameter part, 13 = tip, 14 = opening, 15 = opening, 16 = opening, 17 = protrusion, 18 = tip side shaft, 19 = Constricted part, 21 = Tubular body, 22 = Small diameter part, 23 = Tip, 24 = Opening, 25 = Opening, 26 = Opening, 27 = Protrusion, 28 = Shaft part, 29 = Constricted part, 31 = Tubular Body, 32 = small diameter part, 33 = tip, 34 = opening, 35 = opening, 36 = opening, 37 = projection, 38 = tip shaft, 39 = constricted part, 41 = tubular body, 42 = small diameter part 43 = tip, 44 = aperture, 45 = aperture, 46 = aperture, 47 = protrusion, 48 = tip shaft, 49 = constricted portion, 51 = tubular body, 52 = small diameter portion, 53 = tip, 54 = Opening, 55 = opening, 56 = opening, 57 = protrusion 5, 8 = tip shaft, 59 = constricted section, 141 = pressure transducer, 142 = amplifier, 143 = recorder, 151 = acoustic test function analyzer, 161 = External auditory canal pressure sensor, 162 = Eustachian catheter, 163 = Aeration pressure sensor

 BEST MODE FOR CARRYING OUT THE INVENTION

[0017] The artificial ear canal of the present invention is inserted into the patient's ear canal from the tympanic chamber side, the tip is made to face the cartilage ear canal, and the rear end is in principle located in the tympanic chamber (that is, It ends inside the eardrum) and is kept in the patient's ear canal. Considering ease of handling, the human ear canal of the present invention preferably has a total length of 22 mm or more. Usually, it can be used for most patients with a total length of 30 mm or more. In contrast, the artificial ear canal of the present invention is Therefore, the length of the rear end of the patient should be appropriately excised so that it is suitable for the size of the middle ear of the patient. About 45 mm is sufficient for most patients, but it may be set to 50 mm, 70 mm, etc. as desired, taking into account the convenience of handling, including the part to be excised.

 [0018] The artificial ear canal of the present invention has an elongated shape as a whole because it is inserted into the ear canal of a patient such as the eardrum side. The outer diameter of the rear part of the plurality of protrusions provided on the outer peripheral surface may or may not be constant, but it is usually preferable to keep it within about 3 mm. However, this part has an outer diameter slightly larger than 3 mm as long as it has an elongated shape as a whole, due to the bone ear canal that expands toward the front side and the force that is placed in the wider tympanic chamber. Allowed.

 [0019] The cross-sectional shape of the artificial ear canal of the present invention is not particularly limited. Usually, it may be circular, but since the cross section of the canal is flat, it may be a flat cross section like an ellipse. In addition, the cross-sectional shape may be the same over the entire length of the artificial ear canal, but it may not be, for example, a circular part in the majority of the entire length (for example, from the tip to the portion held between the ear canal) May be elliptical, or may be elliptical in most of the entire length and circular in part (for example, up to a portion where the tip force is also sandwiched between the ear canal portions). Since the cross-section of the canal is a flat shape extending in the front-rear direction from the left and right, if the prosthetic canal has an elliptical cross-section, the protruding part abuts most of the inner peripheral surface of the canal Increase the stability of the fixation of the artificial ear canal. In order to be able to handle various types of patients with the artificial ear canal of the fewest possible dimensional standards, the major axis Z minor axis ratio is limited to 5 even in the case of a flat cross-sectional shape such as an ellipse. Is preferred. For example, it can be 5, 4, 3, 2, etc. The cross-sectional shape and dimensions of the artificial ear canal of the present invention are individually determined by the attending physician in accordance with the shape and condition of the patient's ear canal to be treated. In the case of a flat cross-sectional shape such as an ellipse, the “outer diameter” and the “inner diameter” of the artificial ear canal of the present invention, and the “diameter” in the case of the artificial ear canal means a shorter diameter (short axis). .

[0020] In the present invention, "the part to be clamped in the canal part" means that the artificial ear canal of the present invention faces the tip of the cartilage part through the canal part from the bone part of the canal part to the ear canal. Since it is an artificial eustachian tube that is inserted into the patient's ear canal while being sandwiched between the isthmus, Considering the approximate length (approximately 2Z3 of the entire ear canal), the tip should not be too close to the pharyngeal mouth! Normally, the tip force of the artificial ear canal should be set within the range of several millimeters to several tens of millimeters. However, in the case of a patient with a large physique and a long ear canal, it can be set at a site about 20 mm away from the tip. . Usually, it is preferably within 20 mm from the tip, more preferably within 16 mm.

[0021] In the present invention, the "plurality of protrusions" are for holding the artificial ear canal in a fixed position by the drag received from the canal canal portion in contact with the ear canal portion. Various forms can be adopted as long as they are “dispersed around the outer periphery”. Here, “dispersed around the outer circumference” means that a plurality of protrusions are provided with gaps when viewed in a cross section of the artificial ear canal. Accordingly, the “dispersion around the outer circumference” may be a radial distribution with equal intervals or a non-uniform distribution. The gap between the plurality of projecting portions provided in a distributed manner is the front-rear direction between the inner wall surface of the eustachian tube portion and the outer peripheral surface of the artificial eustachian tube in the state where the artificial canal tube of the present invention is sandwiched between the canal tube portion. It works to secure the flow path.

 [0022] In the present invention, when "a plurality of protrusions are provided to be dispersed in the longitudinal direction", the groups of adjacent front and rear protrusions may be equally spaced or unevenly spaced. In addition, the group of protrusions provided dispersed around the outer periphery and the group of protrusions adjacent immediately after that are the protrusions before the front and rear protrusions may be aligned at the same position around the outer periphery. They may be arranged in a staggered manner so that the rear protrusions are located in the gap, or may be arranged at random.

 [0023] In order to effectively hold the canal portion of various inner diameters, it is preferable that the projecting portion is provided over a range of 5 mm or more in the longitudinal direction of the artificial ear canal. More preferably. Usually, it should be in the range of 5 ~: LOmm.

[0024] The plurality of protrusions provided to be distributed around the outer periphery and in the longitudinal direction are such that the height of the tip as a whole decreases toward the tip side of the artificial ear canal. This is because the protrusions are made smaller toward the end of the prosthetic ear canal, or even if the protrusions are the same size, the outer peripheral surface on the front end side of the prosthetic ear canal is arranged. This can be achieved by tapering down. By doing so, Since the part to be clamped is tapered when viewed as a whole projection group, it becomes easy to insert into the canal part, and the operator can not feel the resistance during insertion by adjusting the depth of insertion. In addition, since the optimal thickness of the artificial eustachian tube can be held between the canal canal, the stability of fixation increases.

 [0025] The shape of the projecting portion is not particularly limited as long as it can leave the outer peripheral surface of the artificial ear canal and abut against the inner wall of the canal canal. However, the shape of the projecting portion should not be sharp or angular so as not to damage the tissue. It is preferable that An example of the protrusion is a hemispherical shape, a stump shape, a cone shape, a truncated cone shape, a pyramid shape, a truncated pyramid shape, a cubic shape, and other polyhedrons, and the ratio of width to height is 1: 2 to 2: This is a ridge protrusion having a relatively low height compared to the width in the range of about 1 (in the present invention, it is generally referred to as “wart-shaped protrusion”). However, it is preferable to eliminate a sharp corner by rounding the tip even in a conical or pyramidal shape. These protrusions may be flexible.

 [0026] Another example of the projecting portion is a projecting ridge extending in the longitudinal direction, which may be a fin-shaped projecting ridge having a height higher than the thickness, or a projecting arch-shaped projecting strip having a greater thickness. Also, a ridge having a rectangular cross section may be used. Such ridges may vary in height in the longitudinal direction, and in particular for the convenience of insertion into the canal canal, the height increases with the rearward force on the distal side. It is preferable. Further, the protrusion may have a plurality of cutouts in the side cross section, and in that case, the cutouts engage with the curved surface of the inner wall of the eustachian tube, and the position change in the front-rear direction of the artificial eustachian tube It works to increase resistance. A typical example of such a cutout is a series of V-shaped cutouts that result in a triangular blade shape with multiple upper edges in the lateral cross section of the ridge. In addition, when the upper edge has a plurality of cutouts, the artificial ear canal can be fixed by the cutouts. It may be reduced. Further, these protrusions may be flexible.

[0027] Yet another example of the protrusion is a rod-shaped protrusion protruding from the outer peripheral surface force. Here, the “rod-like projection” may be a straight extension or a curved one. The thickness may be constant, but may be a taper that changes along the length, such as tapering. The rod-shaped protrusion may protrude perpendicularly from the outer peripheral surface in the radial direction. In order to facilitate the insertion into the isthmus and the stability of the fixing against the rearward slipping, it is preferable to incline backward. The rod-like protrusion is preferably flexible.

 [0028] It should be noted that the outer diameter of the artificial eustachian tube should be selected as appropriate according to the inner diameter of the eustachian tube part affected by the state of tubal stenosis (Eustachian obstruction), eustachian tube openness, etc. and the physique It is a matter. In order to increase the versatility of one artificial auditory canal with respect to the inner diameters of various canal canals, the tip of the protruding portion is usually placed at the site of the canal canal. It is preferable to create it so that the radius is within the range of 0.3 to 3. Omm from the center axis. It is more preferable to create it so that it is within the range of 0.3 to 1.8 mm! /.

 [0029] Since the distal side opening at the distal end of the artificial ear canal of the present invention is an opening for opening the lumen to the side of the cartilage ear canal (that is, the nasal cavity), it is opened in the axial direction of the lumen. However, a distal end side opening may be provided on the side of the distal end portion as a blind end in the axial direction. If the tip is blind, when the artificial ear canal is inserted into the ear canal using a guide wire that passes through the lumen, there is no risk that the tip will hit the blind end of the artificial ear canal and stop moving forward. Since it becomes easy to remove only the guide wire after the insertion of the artificial ear canal, surgery is simplified. However, even when the distal opening is provided at the distal end of the artificial ear canal in the same axial direction as the lumen, the distal end or the vicinity thereof (e.g., the distal end) is narrowed by 0.2 mm or more from the diameter of the lumen. Within 5mm or within 10mm from the top), it is larger than the opening on the tip side by narrowing the inner diameter of the flow path and providing a portion 0.2mm or more narrower than the inner diameter of the lumen behind it. By using a guide wire with a diameter, it is possible to prevent the guide wire from slipping forward, so there is no problem. Further, when the distal end side opening is provided on the side of the distal end portion, the number of openings may be one, but a plurality of openings may be provided. For example, a pair of openings may be provided on both sides of the lumen. When the distal end side opening is provided on the side wall other than the distal end of the artificial ear canal, the position thereof may be appropriately selected between the distal end of the artificial ear canal and the portion to be sandwiched between the ear canal.

[0030] The artificial ear canal of the present invention is externally provided through at least one opening (referred to as "rear opening" in the present specification) behind the site to be clamped by the canal canal part, in addition to the opening on the tip side. Is open. The posterior opening may be provided on the side wall of the lumen or may be the end of the axially open lumen and may include both. An opening in the side wall of the lumen means that if there is exudate in the tympanic chamber, it will be discharged to the nasal cavity side through the lumen. There is an advantage of making it easier. When the posterior opening is provided in the side wall of the lumen, the position and the number thereof may be appropriate.For example, immediately behind a group of protrusions provided at a site to be sandwiched between the ear canal or the tip of an artificial ear canal The force can also be around 20-25mm. One opening may be provided on the side wall, or a plurality of openings may be provided on both sides of the lumen. In addition, the artificial ear canal of the present invention has an opening (for example, a slit-like opening extending over the entire length of the part or a longitudinal direction of the part between the group of protrusions provided in the part to be sandwiched between the ear canal parts. 1 or a plurality of openings) arranged in the same manner. When such an opening is added, the flow and ventilation of the exudate are further promoted in conjunction with the swallowing movement, and a more preferable effect is obtained. Such an additional opening can be provided separately from the rear opening. When the rear opening is provided immediately behind the projections of the group, the additional opening is integrated with the rear opening. You can do it.

 [0031] It should be noted that the insertion of the artificial ear canal into the patient of the present invention typically involves inserting the guide wire into the lumen of the rear end side force and inserting it into the ear canal while supporting the tip wire. Is passed through the ear canal and the tip of the cartilage is exposed to the ear canal. Then, only the guide wire is removed and the artificial ear canal is placed in the tympanic chamber or the bone ear canal. Left behind. Therefore, typically, at the time of insertion, it is preferable that a lumen penetrates and opens as it is at the rear end of the artificial ear canal. However, if the artificial ear canal is made of a sufficiently strong material, the use of a guide wire is not necessary, and the rear end can be closed.

[0032] The distal opening, lumen, and posterior opening are used for air (and exudate in cooperation with the outer protrusion gap) between the cartilage ear canal (ie, the nasal cavity) and the tympanic chamber. By strengthening the distribution, a flow path that fulfills the function of the patient's original ear canal is constructed. This flow path preferably has an inner diameter of at least 0.20 mm. This is because if the diameter of the lumen is too narrow, it may cause a resistance to the flow of air (and possibly exudate) in the lumen, but if it is 0.20 mm or more, there is substantially less concern. . Conversely, if the inner diameter of the flow path is too large over the entire length, there is a risk that the voice will conduct air into the tympanic chamber. In order to prevent this, the inner diameter of at least any part of the flow path is preferably 0.9 mm or less, more preferably 0.8 or less. By providing such a part, the diameter of the remaining part of the flow path is larger. Even if it is a threshold, the voice is surely prevented from being conducted to the tympanic chamber.

 [0033] The artificial ear canal of the present invention achieves communication between the tympanic chamber of the patient and the cartilage ear canal via the lumen of the artificial ear canal, and ensures ventilation between the tympanic chamber and the nasal cavity. One purpose. Therefore, when inserting an artificial ear canal into a patient, the artificial ear canal engages with or near the canal of the canal, the tip of the artificial ear canal faces the cartilage canal, and the distal opening is the cartilage. It is done to open into or against the ear canal. The artificial ear canal inserted into the patient's ear canal is excised if there is an excess in the length of the rear end, and typically the rear end is located inside the eardrum and within the tympanic chamber. And stay in the patient.

 [0034] The artificial ear canal of the present invention can include a shaft portion (referred to as a "tip-side shaft portion") that extends forward from the plurality of protrusions, although it is not essential. Since the distal end side shaft portion serves as a guide during insertion, it is usually preferable to have the distal end side shaft portion. Considering strength and the inner diameter of the lumen, the outer diameter of the distal shaft is usually preferably 0.6-2 mm, but it is as thin as 0.4 mm for patients with a particularly narrow canal. It is also possible to do. Except for these points, the outer diameter of the distal end side shaft portion may be appropriately determined in relation to the height of the most distal end side protruding portion adjacent thereto. Further, the length of the tip side shaft portion may be determined as appropriate, for example, about 4.5 to 6 mm.

 [0035] When the artificial ear canal of the present invention includes the distal end side shaft portion, the distal end side shaft portion is adjacent to the distal end side of the plurality of protruding portions, that is, an annular constricted portion, that is, a portion with a reduced outer diameter. Can be included. The annular constricted portion preferably has a width of 0.5 to 2.5 mm in the longitudinal direction. Depending on the dimensions of the patient's canal, it can be used to engage an annular constriction with the canal. The annular constricted part should be 0.1 to 0.4 mm smaller than the outer diameter of the tip side shaft adjacent to the part!

[0036] The material constituting the artificial ear canal of the present invention is biocompatible, that is, there is no possibility of causing a foreign body reaction harmful to the living body, and there is no possibility of causing decomposition or deterioration in the living body. A flexible material is preferred. As such materials, various materials that have been conventionally used for in-vivo implantation or the like in medical applications can be appropriately used for the production of an artificial ear canal. Examples of flexible synthetic resins include vinyl chloride, silicone, polyethylene, polypropylene, polypentene, polyurethane-based resin, etc. Not limited to ヽ. A metal (for example, titanium) or a ceramic can be used for a part (for example, the constricted portion). In addition, coagulants designed to increase softness when warmed to body temperature are easy to handle because they can maintain moderate hardness during insertion, but become softer at body temperature after insertion. This is more preferable because there is no possibility of giving. Furthermore, by using autologous cartilage formed by culturing as a biomaterial, it is possible to obtain an artificial ear canal having superior safety.

 Example

 [0037] Hereinafter, the ability to more specifically describe the present invention with reference to typical examples. It is not intended that the present invention be limited to these examples.

[Example 1]

 FIG. 1 is a plan view of an example of an artificial ear canal (made of polyurethane) according to the present invention as seen from the rear side. In the figure, reference numeral 1 denotes a tubular body constituting the tube part of the artificial ear canal, and is drawn with the length direction shortened due to limitations of the figure. The tubular body 1 includes a small diameter portion 2 near the rear end. The narrow-diameter part 2 is a thinned part from the eardrum in case the artificial ear canal is inserted into the patient's ear canal and part of the rear end is projected via the eardrum for follow-up. However, it may be removed even if it is not essential for the purpose of the present invention. In the tubular body 1, a lumen passes to the rear end of the force near the tip 3, and opens to the outside through the opening 4 (one of the rear openings) at the rear end. The opening 4 can be used when a guide wire is passed through the artificial ear canal when it is inserted. However, if it can be inserted without using a guide wire, it is not necessary (i.e., the rear end is regarded as the blind end). You can). The tubular body 1 is also provided with an opening 5 (which is one of the rear openings) on the side wall, and is open to the outside through this. In the figure, only one opening 5 is drawn on the front side of the side wall of the tubular body 1, but the back side of the side wall of the tubular body 1 is further symmetric with respect to the central axis of the tubular body 1. An opening may be provided. Further, in addition to or instead of the opening 5, an opening 5 ′ may be provided at a position indicated by a broken line. The tubular body 1 further has an opening 6 (front end side opening) in the vicinity of the distal end 3, through which a lumen is opened to the outside on the distal end side. Thus, the tubular body 1 is provided with a flow path communicating with the outside between the vicinity of the front end and the rear end side.

[0039] In the tubular body 1, a plurality of large and small protrusions 7 are distributed around the outer periphery of the tubular body in a region near the tip. It is provided in a scattered state. To help understanding, the height of the protrusion 7 is somewhat exaggerated in the figure. In this embodiment, the protrusions 7 are provided in a state of being dispersed in the longitudinal direction of the artificial ear canal, and gradually increase in height from the front end side to the rear end side of the artificial ear canal, that is, as a whole. When viewed, the tips are arranged so that the tip height decreases (taperes) toward the tip of the artificial ear canal. In this embodiment, around the outer periphery of the artificial ear canal, four groups of four projections 7 (some of which are hidden behind the tubular body 1 and cannot be seen) are dispersed in the longitudinal direction and arranged in five groups. The projections of each group are arranged so that a part of the rear projection enters between the front projections. This interleaved staggered arrangement, coupled with the gradual increase in height between groups, enhances the compatibility of the prosthetic canal to various sizes of the canal gorge and also allows the projections 7 to move in various directions. Provide a flow path. Each protrusion 7 has a parabolic cross section, and rises while increasing in height from the distal end side to the rear side of the artificial ear canal. This structure facilitates insertion of the artificial eustachian tube into the eustachian tube.

[0040] Between the distal end force of the artificial ear canal and the projection 7, the distal end side shaft portion 8, which is a part of the tubular body 1, extends without the projection 7. An annular constricted portion 9 is provided in a region adjacent to the protrusion of the distal end side shaft portion 8. The constricted portion 9 is used for holding the region between the canal portion when the portion of the canal portion is particularly narrow, and is not essential for the purpose of the present invention, but the canal portion having various dimensions. This is useful for increasing the compatibility of the artificial eustachian tube to the isthmus.

 [0041] The dimensions of the artificial ear canal in the present embodiment can be variously determined in consideration of the inner diameter of the patient's ear canal and the length of the ear canal. For example, the remaining length of the tubular body 1 excluding the small diameter portion 2 is 30 to 32.5 mm, the length of the thin diameter portion 2 is 10 mm, the length of the distal end shaft portion 8 is 6 to 8.5 mm, and Length of constricted part 9 1.5 to 2.5 mm, outer diameter of central part of tubular body 1.50 mm, outer diameter of thin part 2 1.OOmm, maximum diameter of tip side shaft part 8.45 mm, The outer diameter of the constricted portion 9 is 1.30-1.35 mm, and the projections 7 are provided in the range of 6 to 8 mm in the longitudinal direction of the artificial ear canal, and their height is the outer circumference of the tubular body 1 The range is 0.2 to 0.6 mm from the surface.

 [Example 2]

FIG. 2 is a plan view showing a slightly backward force of another embodiment of the artificial ear canal of the present invention. In the figure, 11 is a tubular body constituting the tube portion of the artificial ear canal. The direction is shortened. The tubular body 11 includes a small-diameter portion 12 near the rear end, and the purpose and function of the small-diameter portion 12 are the same as those of the small-diameter portion 2 of the first embodiment. In the tubular body 11, a lumen passes from the vicinity of the front end 13 to the rear end, and opens to the outside through the opening 14 (one of the rear openings) at the rear end. The purpose and function of the opening 14 is the same as the corresponding opening in Example 1. 15 is an opening (one of the rear openings) provided on the side wall of the tubular body 11, and 16 is an opening (tip-side opening) provided near the tip. The openings 15 and 16 may be further provided at symmetrical positions on the back side of the tubular body 11.

 [0043] In the tubular body 11, a plurality of protrusions 17 are provided in a region near the tip in a state of being distributed around the outer periphery of the tubular body, and the gaps form a flow path in the front-rear direction. . To aid understanding, the height of the protrusion 17 is somewhat exaggerated in the figure. The ridge 17 is a fin-like ridge that is taller than the thickness, and has a series of V-shaped notches with N, resulting in a triangular blade shape (sawtooth shape). Have. Further, the ridge 17 increases in height toward the rear on the front end side and decreases in height toward the rear on the rear end side, and has the highest portion in the middle portion. The notches of various heights increase the compatibility of the prosthetic canal to the dimensions of the canal of various patients and stabilize the fixation. The distal end side opening 13, the distal end side shaft portion 18, and the constricted portion 19 are the same as the corresponding portions in the first embodiment.

 [Example 3]

 FIG. 3 is a plan view of a further embodiment of the present invention as seen from the rear side. In the figure, 21 is a tubular body constituting the tube portion of the artificial ear canal, and is drawn with the length direction shortened due to the constraints of the figure. The tubular body 21 includes a small diameter portion 22 in the vicinity of the rear end, and the purpose and function of the small diameter portion 22 are the same as those of the small diameter portion 2 of the first embodiment. In the tubular body 21, a lumen passes from the vicinity of the front end 23 to the rear end, and is opened to the outside through the opening 24 (one of the rear openings) at the rear end. The purpose and function of the opening 24 is the same as the corresponding opening in Example 1. 25 is an opening (one of the rear openings) provided on the side wall of the tubular body 21, and 26 is an opening (tip-side opening) provided near the tip. The openings 25 and 26 may be further provided at symmetrical positions on the back side of the tubular body 21.

[0045] In the tubular body 21, a plurality of large and small curved rod-shaped protrusions 27 are distributed around the outer periphery of the tubular body 21 and also in the longitudinal direction of the artificial ear canal in a region near the tip. Prepared ing. To help understanding, the height of the protrusion 27 is somewhat exaggerated in the figure. The protrusion 27 gradually increases in height from the distal end side to the rear end side of the artificial ear canal, that is, when viewed as a whole, the height of the distal end decreases toward the distal end side of the artificial ear canal (tapering). ) Is arranged as follows. These bar-shaped protrusions 27 with different heights enhance the compatibility of the prosthetic canal to the canal of various dimensions, and increase the resistance to posterior withdrawal, thereby improving the stability of the prosthetic canal. Increase in particular. Between the protrusions 27, flow paths in various directions are provided. In the figure, for example, a group of 14 protuberances 27 (of which 6 are hidden behind the tubular body 21) are arranged around the outer periphery so that they are distributed around the outer periphery. Typically, 6-14 ridges 27 are provided in a distributed manner. The distal end side opening 23, the distal end side shaft portion 28, and the constricted portion 29 are the same as the corresponding portions in the first embodiment.

[Example 4]

 FIG. 4 is a plan view of another embodiment of the present invention as seen from the rear. In the figure, reference numeral 31 denotes a tubular body constituting the tube portion of the artificial ear canal, and is drawn with the length direction shortened due to the constraints of the figure. The tubular body 31 includes a small diameter portion 32 near the rear end, and the purpose and function of the small diameter portion 32 are the same as those of the small diameter portion 2 of the first embodiment. In the tubular body 31, a lumen passes from the vicinity of the front end 33 to the rear end, and is opened to the outside through the opening 34 (one of the rear openings) at the rear end. The purpose and function of the opening 34 is the same as the corresponding opening in Example 1. 35 is an opening (one of the rear openings) provided on the side wall of the tubular body 31, and 36 is an opening (tip-side opening) provided near the tip. The openings 35 and 36 may be further provided at symmetrical positions on the back side of the tubular body 21.

[0047] The tubular body 31 is provided with a plurality of large and small substantially straight rod-shaped protrusions 37 in a region near the tip, inclining backward in a dispersed state around the outer periphery of the tubular body. In this embodiment, the protrusions 37 are provided in a state of being dispersed in the longitudinal direction of the artificial ear canal, and when the height is gradually increased from the front end side to the rear end side of the artificial ear canal, that is, as a whole. It is arranged so that the height of the tip end decreases (taperes) toward the tip side of the artificial ear canal. In this embodiment, around the outer periphery of the artificial ear canal, four groups of protrusions 37 (some of which are hidden behind the tubular body 31 and cannot be seen) are dispersed in the longitudinal direction and arranged in four groups. The protrusions in each group are arranged so that the rear protrusion is located between the front protrusions. High These rod-shaped protrusions 37 of different heights increase the compatibility of the prosthetic canal with various dimensions of the canal canal, increase resistance to posterior withdrawal, and particularly enhance the stability of the prosthetic eustachian tube . Between the projections 37, flow paths in various directions are provided. The distal end side opening 33, the distal end side shaft portion 38, and the constricted portion 39 are the same as the corresponding portions in the first embodiment.

[Example 5]

 FIG. 5 is a plan view of a further embodiment of the present invention as seen from the rear side. In the figure, reference numeral 41 denotes a tubular body constituting the tube portion of the artificial ear canal, and is drawn with the length direction shortened due to the constraints of the figure. The tubular body 41 includes a small diameter portion 42 in the vicinity of the rear end, and the purpose and function of the small diameter portion 42 are the same as those of the small diameter portion 2 of the first embodiment. In the tubular body 41, a lumen passes from the vicinity of the front end 43 to the rear end, and opens to the outside through the opening 44 (one of the rear openings) at the rear end. The purpose and function of the opening 44 is the same as the corresponding opening in Example 1. 45 is an opening (one of the rear openings) provided on the side wall of the tubular body 41, and 46 is an opening (tip-side opening) provided near the tip. The openings 45 and 46 may be further provided at symmetrical positions on the back side of the tubular body 41.

[0049] The tubular body 41 is provided with a plurality of large and small hemispherical projections 47 in a distributed state around the outer periphery of the tubular body in a region near the tip. In the present embodiment, the protrusions 47 are provided in a state of being dispersed in the longitudinal direction of the artificial ear canal, so that the height gradually increases from the front end side to the rear end side of the artificial ear canal, that is, as a whole. As a result, the tips are arranged such that the tip height decreases (taperes) toward the tip side of the artificial ear canal. In the present embodiment, around the outer periphery of the artificial ear canal, a group of protrusions 47 (of which 4 are hidden behind the tubular body 41 and cannot be seen) are arranged on the most distal side, and the rear end side. There are 5 groups of projections 47 (the-part is hidden behind the tubular body 41 and cannot be seen), and 5 groups are distributed in the longitudinal direction. The rear protrusions are arranged between the front protrusions. These protrusions 47 with different heights enhance the compatibility of the prosthetic canal to various dimensions of the canal gorge, increase resistance to posterior withdrawal, and increase the stability of the fixation of the prosthetic canal . Between the protrusions 47, flow paths in various directions are provided. The front end side opening 43, the front end side shaft portion 48, and the constricted portion 49 are the same as the corresponding portions in the first embodiment. [Example 6]

 FIG. 6 is a plan view seen from a slightly rear side of still another embodiment in which the artificial ear canal of the fifth embodiment is partially changed. In this embodiment, the protrusions 57 are all the same size, and the outer diameter of the force tube 51 is partially enlarged to provide a tapered area on the surface (in this embodiment, the rear side In this case, the outer diameter is restored again), and the protrusions 57 are arranged on the tapered surface so that the shape of the protrusions is tapered when viewed as a whole. The distal end side opening 53, the distal end side shaft portion 58, and the constricted portion 59 are the same as the corresponding portions in the first embodiment.

[0051] [Clinical trial]

 Some of the results of clinical trials treated by inserting the artificial ear canal of the present invention into a patient are described below.

[0052] (Test method)

 Eustachian tube function test: Eustachian tube function tests were performed by the pressure-depressurization method, the acoustic eustachian tube method, and the eustachian tube force aeration method.

 In the pressure-decompression method, air pressure is applied to the ear chamber from the ear canal side at a constant speed through the tympanic membrane, and the pressure at which the eustachian tube naturally opens (referred to as passive open pressure or reverse ventilation pressure) is examined. There is a physical examination and a dynamic examination in which a certain positive or negative pressure is applied to the middle ear from the external auditory canal side and the degree of opening of the ear canal by swallowing (active opening) is examined. According to the pressurization and decompression method, in the case of a healthy ear canal, even if the external ear side tympanic pressure is increased, the ear canal is opened by swallowing movement, so that recovery by rapid decompression can be seen. In addition, even if the applied air pressure is gradually increased, if the air pressure exceeds a certain level, the ear canal is passively expanded and opened (passive expansion). . In contrast, in ear canal stenosis, the ear canal remains closed during swallowing, so the tympanic air pressure does not decrease even after repeated swallowing, and the tympanic pressure is quite high. Otherwise, the passive expansion of the ear canal will not occur. Passive open pressure is normal when the average of normal ears is about 355 daPa, and the standard deviation X 2 is considered normal, and when it exceeds 545 daPa, it can be judged as abnormal.

[0053] For the inspection by the pressure reduction method, the eustachian function test device ET— manufactured by Nagashima Medical Instruments Co., Ltd. 1000 was used (conceptually shown in Figure 7). When the device channel is loaded with air pressure (positive pressure or negative pressure) from the outer ear side of a tympanic membrane perforated patient and the ear canal is released (by swallowing or loading) The pressure change (due to the increase in air pressure) was measured with the pressure transducer 141, amplified with the amplifier 142, recorded on the recorder 143, and evaluated.

 [0054] The acoustic eustachian tube method examines the open / closed state of the eustachian tube by monitoring changes in sound pressure during swallowing using a microphone attached to the external auditory canal while projecting the sound of a load sound source force into the nasal cavity. It is a method. If the eustachian tube is enlarged during swallowing, sound in the nasal cavity conducts air through the eustachian tube and reaches the outer ear, so the presence or absence and degree of ear canal stenosis are evaluated based on changes in sound pressure captured by the microphone on the ear canal side. can do.

 [0055] For the examination by the acoustic eustachian tube method, an eustachian function inspection apparatus ET-1000 manufactured by Nagashima Medical Instruments Co., Ltd. was used (conceptually shown in FIG. 8). The channel of the device 151 was adjusted to the acoustic ear canal function test, and the swallowing motion and the sound pressure of the ear canal were simultaneously monitored to evaluate the presence or absence of the ear canal during swallowing.

 [0056] The test using the eustachian catheter aeration method is a method of measuring the change in the middle ear cavity pressure by increasing the aeration pressure of the catheter inserted from the nasal cavity side, as conceptually shown in FIG. In normal cases, an increase in middle ear pressure is usually observed at a ventilation pressure of about 8 kPa. In the figure, 161 is an external auditory canal pressure sensor, 162 is an ear canal catheter, and 163 is a ventilation pressure sensor. Also, the aeration pressure at point A is the open canal pressure (kPa).

[0057] (Case 1) A 16-year-old male patient. Right ear canal, almost always with the air in the ear and nose in circulation, and the acoustic method of the eustachian function test shows a ski slope-like curve with a long duration of eustachian tube opening. (Fig. 10), Talval Valsalva ventilation has an abnormally low open pressure of the ear canal of 14 daPa (Fig. 11), and middle ear pressure fluctuations are large even in deep nasal breathing (Fig. 12). In the pressure reduction test (Fig. 13) through the tympanic membrane perforation from before surgery, when the middle ear pressure rises to lOdaPa, the ear canal opens, the load pressure is released, and the ear canal is at a very low pressure. Open. All were findings of open ear canal. An artificial eustachian tube having a triangular blade-like projection of the type of Example 2 was created and inserted. On the 10th day after surgery, the subjective symptoms such as clogging of the ears and breathing sound were also greatly improved. With the acoustic method, the ski slope-like curve disappeared and the ears were swallowed. The duration of tube opening was normalized (Figure 14). In the canal catheter aeration using a catheter, the open pressure of the eustachian tube was 9 kPa, which was in the normal range (Fig. 15). It should be noted that the open canal pressure is an objective measurement of the canal catheter air permeability. When the catheter vent pressure is increased and the change in the middle ear cavity pressure is detected by the pressure sensor, it is usually around 8 kPa. However, in this case, the preoperative ear canal pressure was about lkPa, and it was clearly diagnosed as open ear canal (Figure 15). Industrial applicability

 According to the present invention, an effective and simple treatment of a floppy tube that causes tubal stenosis, thoracic canalism, or both occlusion and opening, treatment of adhesive otitis media, eardrum after exudative otitis media surgery An artificial eustachian tube with greatly enhanced exudate excretion function, which can be used to prevent adhesion of pearls and recurrence of pearl seeds, is provided.

Claims

The scope of the claims

 [1] It has a tip, a rear end, and a lumen. The tip of the cartilage part is exposed to the ear canal part through the ear canal part from the bony part of the ear canal, and is sandwiched between the ear canal part. An artificial eustachian tube to be placed in the tube,

 At least at the part to be sandwiched between the ear canal part, the outer peripheral surface is provided with a plurality of protrusions dispersed around the outer periphery,

 The lumen is open to the outside through at least one distal-side opening at the site of the artificial ear canal and at or near the distal end of Z.

 Behind the site, the lumen is open to the outside through at least one posterior opening

 An artificial eustachian tube characterized by that.

 [2] The artificial ear canal according to claim 1, wherein a plurality of projecting portions are further dispersed in the longitudinal direction of the artificial ear canal on the outer peripheral surface at least at a portion sandwiched between the canal canal portions.

 [3] The plurality of protrusions provided around the outer periphery and distributed in the longitudinal direction are such that the height of the tip as a whole decreases toward the tip side of the artificial ear canal. The artificial eustachian tube of claim 2.

 4. The artificial ear canal according to any one of claims 1 to 3, wherein the protrusion is a warped protrusion.

 [5] The projecting portion is a ridge extending in the longitudinal direction of the artificial ear canal, and standing up while increasing in height toward the rear at the distal end side thereof. Any artificial ear canal.

 6. The protruding portion is a ridge extending in the longitudinal direction of the artificial ear canal, and the ridge has a plurality of cutouts at the upper edge in a lateral cross section thereof. Any one of the ear canal.

 7. The artificial eustachian tube according to claim 6, wherein the ridge has a triangular blade shape in which a plurality of ridges are arranged in a lateral cross section.

 [8] The artificial ear canal according to claim 6 or 7, wherein the protrusion is directed rearward on the rear end side to reduce its height.

[9] The projecting portion is a rod-like projection that also projects an outer peripheral surface force of the artificial ear canal. Any of the artificial eustachian tubes.

 [10] The artificial ear canal according to any one of claims 1 to 9, wherein the portion to be sandwiched between the ear canal portions is located within 20 mm from the tip of the artificial ear canal.

11. The artificial ear canal according to any one of claims 1 to 10, wherein the protrusion is provided over a range of 5 mm or more in the longitudinal direction of the artificial ear canal.

12. The artificial eustachian tube according to any one of claims 1 to 11, wherein the protruding portion is provided on the rear side from a position of 4.5 mm from the distal end of the artificial ear canal.

[13] The method according to any one of claims 1 to 12, wherein the tip of the projecting portion is located within a range of 0.3 to 3. Omm in diameter from the central axis of the artificial ear canal in a portion to be sandwiched between the ear canal portions. An artificial eustachian tube.

 [14] A ring-shaped constricted portion is included on the distal side of the artificial ear canal adjacent to the projecting portion provided at a position distant from the distal end of 4.5 mm from the distal end of the artificial ear canal. The artificial ear canal according to any one of Items 1 to 13.

 [15] The flow path having at least an inner diameter of 0.2 mm or more through which the distal end side opening, the lumen, and the rear side opening communicate with the inside and the outside of the artificial ear canal, are provided. The artificial ear canal according to any one of claims 1 to 14, wherein the flow path has a portion having an inner diameter of 0.9 mm or less.

 [16] The artificial ear canal according to any one of claims 1 to 15, wherein the rear opening is open on a side wall of the artificial ear canal.

 17. The artificial ear canal of claim 16, wherein the posterior opening is also open at the rear end of the artificial ear canal.

[18] The artificial ear canal according to any one of claims 1 to 17, wherein the total length is 22 mm or more.

[19] The artificial ear canal according to any one of claims 1 to 18, which is made of flexible rosin.