JP5992922B2 - Eustachian tympanic tube - Google Patents

Description

  The present invention relates to an artificial ear canal that is embedded in a human ear canal in a state where the rear end is exposed outside the eardrum for the treatment of the middle ear including the ear canal.

  The ear consists of the outer ear, middle ear and inner ear. The outer ear and the middle ear are partitioned by the eardrum located at the inner edge of the ear canal. The middle ear consists of the tympanic chamber (middle ear cavity) that contains the ear ossicles (Tut, Kinuta and Abumi bones) that connect the eardrum and the vestibular window (which leads to the vestibule of the inner ear) and the pharynx extending from the tympanic chamber The ear canal is open to the The eustachian tube begins in the tympanic vestibule (the tympanic ear canal), extends obliquely from the upper back and rear to the lower front and opens in the pharyngeal side wall (the canal and pharyngeal mouth). The eustachian tube is about 33 mm in length, the upper side about 1/3 passes through the temporal bone, and the lower side about 2/3 is wrapped with cartilage. The bony ear canal passes through the narrowed tympanic ear canal and then gradually narrows, becomes the thinnest at the cartilage entry site (the ear canal), and is normally closed at this position. Below the eustachian tube part, the eustachian tube gradually becomes thicker and opens in a trumpet shape at the pharyngeal mouth. One function of the eustachian tube is the ventilation function. This is because active contraction of the palatal canal muscle during contraction and swallowing causes the lower wall of the cartilage to be pulled downward, the lumen of the ear canal temporarily opens, and air flows from the pharynx into the tympanic chamber. It can be divided into a normal type and a passive type that is passively ventilated with changes in the external pressure. In healthy ears, the intratympanic pressure is kept equal to the external pressure because of the ventilatory function of the eustachian tube, especially the active ventilation function. The eustachian tube also functions to excrete middle ear secretions into the pharynx. The state in which these functions are impaired, that is, ear canal dysfunction, includes ear canal stenosis (ear canal obstruction), ear canal opening, and ear canal insufficiency.

  Eustachian stenosis is a condition in which the expansion of the eustachian canal that occurs due to swallowing or distraction is impaired for some reason, and ventilation of the middle ear through the eustachian tube is impaired. The cause of this is organic stenosis of the eustachian tube due to inflammation of the nasopharynx, etc., and functional stenosis due to dysfunction of the open canal muscularis (palatic scapularis) such as cleft palate. When ventral stenosis impedes ventilation of the middle ear, oxygen in the tympanic chamber is absorbed from the surrounding mucosa, and the tympanic chamber becomes negative pressure and the tympanic membrane is indented. As a result, symptoms such as ear tightness, hearing loss, and hearing loss. 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. The exudate fills up into the tympanic chamber, resulting in conductive hearing loss and ear obstruction, as well as recurrent acute otitis media. It becomes easy to suffer from. In addition, when the tympanic chamber is placed in a chronic and irreversible negative pressure state, the tympanic membrane adheres to the middle ear wall. It also causes cholesteatogenic otitis media, a disease in which the keratinized squamous epithelium proliferates and destroys the surrounding bone in the process.

  For the treatment of ear canal stenosis, so-called ear canal ventilation therapy, in which a catheter is inserted into the pharyngeal mouth and ventilated, is frequently used. Other treatments include steroid hormone injection into the ear canal from the pharynx side or tympanic cavity side, and steroid hormone injection around the ear canal and pharyngeal mouth, but the effect is objectively established. It has not been done. Conservative treatment with medication includes systemic administration of anti-inflammatory enzyme preparations and drugs with antiallergic effects, and nasal steroids, which require long-term medication and are effective in patients with moderate or higher severity. There is a problem that there are many cases where it cannot be obtained sufficiently. 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 is fitted into a perforation or incision part opened in the eardrum, and various sizes and shapes are commercially available. One of the most commonly used is a central constricted tube having a length of about 3 mm. However, although the tympanic tube can provide ventilation of the tympanic chamber, the ear canal stenosis itself is not sufficiently improved, and ventilation and excretion through the ear canal are not necessarily restored. Recently, a treatment method for cauterizing the mucous membrane in the ear canal from the pharyngeal mouth side with a laser (carbon dioxide laser, KTP laser) has been developed for cases resistant to treatment with drugs. However, there are many unclear points about the effects on the surrounding tissue when cauterizing the inner part near the canal canal, and sufficient anatomical knowledge and advanced surgical techniques are required to perform eustachian cauterization. Mastering is essential and has not been done widely and easily.

  Eustachian tube is a condition in which the eustachian tube is always open. The patient's subjective symptoms include self-hearing due to his own voice reaching the middle ear through the eustachian tube, Some people complain of dizziness because they can hear breathing sounds and have a 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 disease, atrophy of the peritubular mucosa due to weight loss, and scarring after adenoid surgery, but the cause is unknown.

  Examples of drug therapy for eustachian tube include besolt method (Bezold) in which mixed powder of boric acid and salicylic acid is sprayed into the ear canal with an ear tube catheter, injection of gelatin sponge solution into the ear canal lumen, etc. Surgical treatment includes injection of liquid silicone, otic mucosal cautery, palatal scapular muscle movement, implantation of cartilage pieces or adipose tissue around the ear canal, and collagen injection, but pharmacotherapy continues for a long time. There is a problem that surgical treatment is necessary and surgical therapy is ineffective. In addition, as a device for treatment of eustachian tube and intubation insufficiency, a flattened eustachian pin with a taper that is placed in the lumen of the middle ear canal and about 5 to 15 mm from the eardrum is proposed. (Patent Document 1), however, this works so as to block the cross section of the ear canal and cannot be applied to ear canal stenosis.

  In addition, so-called floppy tubes have recently attracted attention from the viewpoint of the function of the eustachian tube. A floppy tube is an ear canal that easily closes and becomes open, and becomes open when triggered by lack or swallowing, resulting in self-hearing and a feeling of ear closure. In order to resolve these discomforts, patients often become unconsciously sniffing (which causes negative pressure in the tympanic chamber and closes the ear canal), which becomes habitual and makes the tympanic chamber chronic and irreversible As described above in relation to tubal stenosis, it can cause exudative otitis media, adhesive otitis media, and cholesteatoma otitis media.

  As described above, abnormalities of the eustachian tube function cause various diseases of the middle ear. However, it is possible to effectively and easily treat a ureteral stenosis, an eustachian tube opening, or a floppy tube that causes both obstruction and opening. Also, there is a need for a reliable treatment method that can be used for the treatment of adhesive otitis media, prevention of tympanic membrane adhesion after surgery for exudative otitis media, prevention of recurrence of pearl species, and the like.

  For this purpose, the present invention inserts a tube of a predetermined form from the tympanic membrane side into the tubal isthmus through the tympanic membrane and positions the tip in the cartilage portion of the ear canal, while positioning the tube wall opening in the tympanic chamber. An artificial ear canal is proposed in which the rear end is passed through an eardrum tube attached to the eardrum and is left outside the eardrum (Patent Document 2).

  Furthermore, the present inventor has proposed an artificial ear canal (Patent Document 3) designed to be placed in the form of being embedded in the inner side of the eardrum from the cartilage portion of the ear canal to the tympanic chamber, and to be embedded in the inner side of the eardrum as such. Also proposed is an artificial eustachian tube adapted to protrude the rear end from the eardrum (Patent Documents 4 and 5).

JP 2002-224157 A WO 2005/044161 WO 2005-0823303 WO 2006-049131 WO 2006-118072

  Of the artificial ear canal, the tip is made to reach the ear canal and reach the cartilage canal, while the rear end is arranged to protrude into the ear canal through the eardrum tube fitted in the eardrum. Has the advantage over a fully implantable prosthetic canal that it can be easily removed as needed after installation. This type of artificial eustachian tube remains in a fixed position after insertion as long as the appropriate size for the patient is inserted into the eustachian tube, causing misalignment such as falling into the back of the eardrum There is little possibility. However, it is desirable to be able to ensure that the position of the artificial ear canal is maintained more reliably.

  In the above background, the present invention is arranged so that the distal end portion reaches the ear canal portion and faces the inner ear canal of the cartilage portion, while the rear end portion protrudes into the ear canal through the eardrum tube member fitted to the eardrum. Therefore, an ear canal tympanic tube comprising an artificial eustachian tube member, which is an elongated tube inserted to a depth where the tip of the cartilage canal reaches the tip, and a tympanic membrane tube member fitted into the perforation of the tympanic membrane through the tube. Thus, the artificial ear canal member can be easily removed from the eardrum tube member at any time after being attached to the patient's ear canal, while the positional relationship between the artificial ear canal member and the eardrum tube member is accidental. An object of the present invention is to provide an ear canal tympanic tube in which the risk of slippage can be substantially avoided, and in particular, there is no risk that the rear end of the artificial ear canal member will fall behind the ear drum.

The above object is achieved by the invention provided below. Ie:
1. The front end portion and the rear end portion are connected to each other by a through-hole including a central portion having a relatively small outer size and a front end portion and a rear end portion having relatively large outer dimensions, which are mounted across the tympanic membrane. A tympanic membrane tube member which is a short tubular member,
To be inserted out of the eardrum in the external auditory canal through the tip for insertion into the ear canal from the tympanic chamber side and facing the cartilage part through the ear canal and into the ear canal through the through hole of the eardrum tube member mounted across the eardrum An elongate tube having a rear end and an artificial eustachian tube member having a rear end opening and at least one distal opening, the openings being in communication by a lumen An ear canal tympanic tube comprising a rear end portion of the artificial eustachian tube member having an outer dimension enlarged portion which is a portion having an outer dimension larger than the inner diameter of the through hole of the tympanic membrane tube member.
2. The ear canal tympanic membrane according to 1 above, wherein the distal end portion of the artificial eustachian tube member includes a region made of a material or a sieve-like structure that allows movement of air and / or water instead of the opening on the distal end side. tube.
3. 3. The ear canal tympanic tube as described in 1 or 2 above, wherein the outer dimension enlarged portion is an enlarged portion of the outer diameter of the artificial ear canal member.
4). The ear canal according to 1 or 2 above, wherein the outer dimension enlarged portion is formed by a flange formed at the rear end portion or at least one protrusion extending laterally from a part of the outer periphery of the rear end portion. Tympanic tube.
5. The outer dimension enlarged portion is a flange formed at a rear end portion of the artificial eustachian tube member, the flange includes at least one notch portion, and the eardrum tube member is snapped into the notch portion. 4. The ear canal tympanic tube as described above, wherein the rear end portion has a rearwardly projecting portion that can be engaged with the ear canal.
6). The outer dimension enlarged portion is formed by at least one projecting portion extending laterally from a part of the outer periphery of the rear end portion of the artificial eustachian tube member, and the eardrum tube member snaps the projecting portion. 4. The ear tympanic membrane tube according to 4 above, wherein the rear end portion is provided with a recess having a shape to be accommodated.
7). 7. The ear canal tympanic tube according to any one of the above 1 to 6, wherein the artificial eustachian member has a lateral hole on the side surface that communicates the lumen of the tube and the outside of the tube.
8). At least one protrusion is formed on the side surface of the artificial ear canal member in front of the outer dimension enlarged portion, and when the artificial ear tube member is passed through the through hole of the eardrum tube member, the eardrum tube member is the protrusion. And the outer dimension enlarged portion are provided at a first position which is a position allowing the artificial ear canal member to be held in a shape sandwiched between the outer dimension enlarged portion, and the protrusion is provided on the eardrum tube member. 8. The ear canal tympanic tube according to any one of 1 to 7 above, which can pass through the through hole and is configured to snap-engage with the edge of the through hole.
9. 8. The ear canal tympanic tube as described in 8 above, wherein 1 to 6 protrusions are provided along the outer periphery of the artificial eustachian tube member.
10. In front of the first position, at least one additional protrusion on the side of the prosthetic eustachian tube member, the tympanic tube member being sandwiched between the additional protrusion and the protrusion in the first position A second position which is a position that allows the artificial ear canal member to be held in an open shape, the additional protrusion being able to pass through the through hole of the eardrum tube member and 8. The ear canal tympanic tube according to the above 8 or 9, wherein the edge of the through hole is configured to be engaged in a snap-type manner.
11. 10. The above-mentioned ear canal tympanic tube, wherein 1 to 6 further protrusions are provided along the outer periphery of the artificial ear canal member.
12 At least one protrusion is formed on the side surface of the artificial ear canal member in front of the outer dimension enlarged portion, and when the artificial ear tube member is passed through the through hole of the eardrum tube member, the eardrum tube member is the protrusion. And the outer dimension enlarged portion are provided at a first position which is a position allowing the artificial ear canal member to be held in a shape sandwiched between the outer dimension enlarged portion and the through hole of the eardrum tube member. 8. The ear canal tympanic tube according to any one of 1 to 7 above, wherein a longitudinal groove capable of receiving the protrusion and allowing it to pass back and forth is formed on the inner peripheral surface.
13. 12. The twelve ear tympanic tube described above, wherein 1 to 6 protrusions are provided along the outer periphery of the artificial eustachian tube member.
14 In front of the first position, at least one additional protrusion on the side of the prosthetic eustachian tube member, the tympanic tube member being sandwiched between the additional protrusion and the protrusion in the first position And the additional protrusion is formed on the inner peripheral surface of the through hole of the eardrum tube member. 15. Twelve ear tympanic tube according to the above 12 or 13, which can pass back and forth through the longitudinal groove. 14. The ear canal tympanic tube as described in 14 above, wherein 1 to 6 further protrusions are provided along the outer periphery of the artificial ear canal member.

  The ear canal and tympanic tube of the present invention having the above-described configurations is a floppy tube for any patient with ear canal stenosis (ear canal obstruction), ear canal opening or ear canal insufficiency). It is also effective for the patients who have the disease to properly restore the ventilatory function and excretion function of the eustachian tube, and to fundamentally treat various middle ear diseases caused by these eustachian tube dysfunctions. Further, in the ear canal tympanic tube of the present invention, since the rear end portion of the artificial ear canal member cannot pass through the tympanic tube member, the artificial ear canal member reliably stops outside the ear drum tube member, and from the ear drum tube member to the tympanic chamber side. The possibility of falling off can be eliminated.

  Further, in the case where the outer dimension enlarged portion of the rear end portion of the artificial ear canal member and the eardrum tube member are engaged with each other in a snap-type manner, there is no possibility that the artificial ear canal member comes off to the ear canal side.

  In addition, a protrusion provided on the side surface of the artificial ear canal member that snap-engages with the edge of the through hole of the eardrum tube member similarly holds the artificial ear canal member stably with respect to the eardrum tube member. Protrusions provided in multiple stages in the front-rear direction of the artificial ear canal member are the tympanic membranes at a plurality of positions between these protrusions or between the rearmost protrusion and the outer diameter enlarged portion of the rear end portion of the artificial ear canal member. The tube member can be guarded, and the insertion depth can be changed while stabilizing the holding of the artificial eustachian tube member.

  Furthermore, the combination of the protrusions on the side surface of the artificial ear canal member and the tympanic tube member in which the longitudinal grooves are formed so that the protrusions can pass through the through-holes are used after the protrusion passes through the through-holes of the eardrum tube member. By rotating the eustachian tube member by an appropriate angle with respect to the eardrum tube member, the protrusion and the eardrum tube member can be engaged, and the operation becomes easier.

FIG. 1 is a perspective view of (a) an artificial eustachian tube member and (b) an eardrum tube member constituting the ear canal tympanic tube of Example 1. FIG. FIG. 2 is a perspective view of an artificial eustachian tube member constituting the eustachian tympanic tube of the second embodiment. FIG. 3A is a rear end view of the artificial eustachian tube member constituting the ear canal tympanic tube of Example 2, and FIG. 3B is a rear end view of the modification. FIG. 4 is a perspective view of the eardrum tube member constituting the ear canal tympanic tube of Example 2 from an oblique rear side. FIG. 5 is a partial perspective view showing the engagement relationship between the artificial ear canal member and the ear drum tube member in the ear canal tympanic tube of Example 2. FIG. FIG. 6 is a perspective view showing the whole of the ear canal tympanic tube in a state where the artificial ear canal member and the tympanic tube member of Example 2 are integrally engaged. FIG. 7 is a perspective view of an artificial eustachian tube member constituting the eustachian tympanic tube of Example 3. FIG. 8 is a perspective view of the eardrum tube member constituting the ear canal tympanic tube of Example 3 from an oblique rear side. FIG. 9 is a perspective view showing a state immediately before the engagement between the artificial ear canal member and the eardrum tube member in the ear canal tympanic tube of Example 3. FIG. FIG. 10 is a partial perspective view showing the engagement relationship between the artificial ear canal member and the eardrum tube member in the ear canal tympanic tube of Example 3. FIG. FIG. 11 is a perspective view showing the whole of the ear canal tympanic tube in a state where the artificial ear canal member and the tympanic tube member of Example 3 are integrally engaged. FIG. 12 is a perspective view showing the whole of the ear canal tympanic tube of Example 4 as a modification of the ear canal tympanic tube of Example 3. FIG. FIG. 13 is a perspective view of an artificial eustachian tube member constituting the eustachian tympanic tube of Example 5. FIG. 14 is a perspective view of an artificial eustachian tube member constituting the eustachian tympanic tube of Example 6. FIG. 13 is a perspective view of (a) an artificial eustachian tube member and (b) an eardrum tube member constituting the ear canal tympanic tube of Example 7.

  The ear canal tympanic tube of the present invention is an artificial ear canal member inserted through the through hole of the tympanic tube member, inserted into the ear canal of the patient from the tympanic chamber side, with the tip facing the cartilage ear canal, It is held in the ear canal of the patient while being held by the tympanic tube member. In consideration of ease of handling, the total length of the artificial eustachian tube member is preferably in the range of 20 to 40 mm. However, there is no particular upper limit on the total length of the artificial eustachian tube member because the distal end side can be appropriately excised and used so as to have a length suitable for the size of the middle ear of the patient at the time of use.

  The artificial eustachian member may be curved as a whole along the shape of the human eustachian tube, which is a slender shape as a whole because it is inserted into the patient's ear canal from the eardrum side. As long as it is made of a flexible material, it may extend linearly as a whole. . The outer diameter of the artificial eustachian tube member is preferably in the range of about 0.8 to 2 mm even at the thickest part except for the rear end portion fixed to the tympanic membrane tube member. The outer diameter may or may not be constant along the longitudinal direction, but it is preferable that the outer diameter is slightly tapered toward the tip, but it is not essential.

  The artificial ear canal member has a rear end side opening and at least one front end side opening, and these openings communicate with each other through the lumen of the artificial ear canal member.

The distal opening at the distal end of the artificial eustachian tube may be opened in the axial direction of the lumen (ie, forward), or the lumen may be closed axially at the distal end (blind end) You may provide the front end side opening in the side of a part. Further, the opening on the distal end side may include both those opened in the axial direction of the lumen and those provided on the side of the distal end portion.
In the case where the distal end side opening is provided on the side of the distal end portion, one such side opening may be provided, but a plurality of such side opening may be provided, for example, as a pair of openings on both sides of the distal end portion of the lumen. It may be provided. When the distal end side opening is provided on the side of the distal end portion, the position thereof is close to the distal end of the artificial eustachian member, for example, within 3 mm from the distal end so that the artificial auditory canal member does not need to protrude too long into the cartilage canal More preferably, it is provided so that at least the front edge of the opening on the tip side is within 2 mm from the tip. Further, the rear end side opening of the artificial eustachian member may be a tube having a lumen opened in the axial direction at the rear end of the artificial eustachian member.

  In addition, the distal end portion of the artificial eustachian tube member does not need to have a distal end opening as long as the movement of air and / or water at the site can be achieved, and instead of providing the distal end opening, movement of air and / or water is possible. (For example, a porous material, for example, a composite of porous materials such as GORE-TEX (registered trademark)), or a sieve-like structure that allows movement of air and / or water (for example, , Network area, lattice structure, etc.) at the tip.

  Although not required, the artificial eustachian tube member may have a lateral hole in the side surface that communicates with the lumen, and such a lateral hole is formed through the lumen when exudate is present in the tympanic chamber. This has the advantage of facilitating the discharge of nasal cavity into the nasal cavity. The position and number of such lateral holes may be arbitrary, but may be, for example, a position immediately behind the part to be sandwiched between the canal canal parts, or about 20 to 25 mm from the tip of the artificial ear canal member. it can. One side hole may be provided on the side surface, or a plurality of side holes may be provided.

  The lumen of the artificial eustachian member is free from the flow of air and exudate between the cartilage eustachian tube (and hence the nasal cavity) and the tympanic chamber if the artificial eustachian member has the lateral holes on the side. Thus, a flow path that functions as the patient's original ear canal is constructed. The 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, resistance to the flow of air (and possibly exudate) therein may occur, but if it is 0.20 mm or more, there is substantially no concern. On the other hand, if the inner diameter of the flow path is too large over the entire length, the voice may be conducted 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 mm or less. By providing such a portion, even when the diameter of the remaining portion of the flow path is larger, the voice is surely prevented from being conducted to the tympanic chamber. Considering the ease of handling when the guide wire is used for insertion, the inner diameter of the lumen is usually preferably in the range of 0.6 to 0.9 mm.

  The cross-sectional shape of the artificial eustachian tube member is not particularly limited, and may be generally circular. The cross section of the eustachian tube is flat. For example, in the case of Eustachian tube stenosis, if an artificial eustachian tube member with a roughly circular tip section is inserted into the Eustachian canal, this will push the flat inner peripheral surface of the Eustachian canal somewhat. A slight gap is formed between the outer wall of the distal end portion of the eustachian tube member and the inner wall of the eustachian tube portion, which is advantageous in securing a discharge flow path for the secretory fluid in the tympanic chamber. Further, the artificial eustachian tube member may have a flat cross section such as an ellipse. In addition, the cross-sectional shape may be the same over the entire length of the artificial eustachian tube member, but it may not be, for example, a circular portion in a large part of the entire length (for example, from the tip to a portion to be clamped in the canal portion) May be elliptical, or may be elliptical in most of the entire length and circular in part (for example, from the tip to the portion sandwiched between the ear canal portions). Since the cross section of the eustachian tube part is a flat shape extending in the front-rear direction from the left and right, when the artificial eustachian member has an elliptical cross section, it closely contacts most of the inner peripheral surface of the eustachian tube part. In order to be able to cope with various types of patients with artificial ear canal members with as few dimensions as possible, the major axis / 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 size of the artificial ear canal member to be selected are individually determined by the attending physician according to the shape and condition of the patient's ear canal to be treated. In the present invention, when the prosthetic eustachian tube member has a flat cross-sectional shape such as an ellipse, the “outer diameter” and “inner diameter” refer to the longer diameter (major axis). To do.

  The artificial eustachian tube is inserted into the patient's eustachian tube in the state where the tip of the artificial eustachian tube is sandwiched between the ear canal and the canal portion through the eustachian tube and the cartilage tube canal. It is a member. When mounting, consider the approximate length of the ear canal of the cartilage (about 2/3 of the total length of the ear canal) so that the tip of the artificial ear canal is at an appropriate position that is not too close to the pharyngeal mouth. The length of the artificial eustachian member is selected.

  The rear end portion of the artificial eustachian tube member is provided with an “outer dimension enlarged portion” that is a portion having a larger outer dimension than the front portion. Corresponding to this, the eardrum tube member is selected to have an inner diameter that allows the rear end portion of the artificial eustachian tube member not to pass but allows the portion on the tip side to pass therethrough. This outside dimension enlargement part is intended to prevent other parts of the prosthetic eustachian tube member from passing through the through hole of the eardrum tube member but only the rear end part. The method of increasing the size, and thus the shape of the outer dimension enlarged portion, is arbitrary, and the degree of increase can be appropriately set in consideration of the ease of handling of the artificial eustachian tube member. For example, even if the outer diameter of the tube itself is enlarged at the end of the artificial ear canal member, the artificial ear canal member has a lateral protrusion at the rear end of the tube portion. It may be due. An example of a protruding part from the pipe to the side is a flange that protrudes so as to radially surround the entire circumference of the rear end of the pipe. May be completely missing. Further, instead of such a flange, a projecting portion extending outward may be formed only in a partial region of the entire circumference. When it is not necessary to remove only the artificial eustachian tube member after attaching the eustachian tympanic tube to the patient, after the attachment, an adhesive (for example, Aron Alpha: registered) (Trademark). When bonded, there is no possibility that the artificial eustachian member will fall out to the tympanic chamber side, and there is no possibility that the artificial ear canal member will come out to the ear canal side.

  In the present invention, the eardrum tube member is a thick and short member fixed to the eardrum in order to secure a through hole passing through the inside and outside of the eardrum, and is disposed across the perforation or incision portion opened in the eardrum. A member having a central portion with a small outer dimension and both end portions with a relatively large outer dimension sandwiching the central portion, and including a through hole between both ends. In the field of otolaryngology, tympanic membrane tubes of various shapes are well known and sold. From these eardrum tubes, those having an appropriate inner diameter of the through hole can be appropriately selected and used as the eardrum tube member in the present invention. Also, the basic structure of the tympanic tube member is a tube having both end portions having a larger outer dimension than the central portion, and such a structure is used together with the artificial ear canal member in the present invention. What is necessary is just to manufacture and use the thing of the suitable specific structure suitably.

  In addition, if the rear end portion of the artificial ear canal member and the eardrum tube member are formed so that they are engaged with each other, the external force in the direction of pulling the artificial ear canal member may be accidentally applied. However, the position of the artificial eustachian tube member can be stably maintained. For this purpose, for example, a projecting portion and a recessed portion (or notch portion) that can be engaged with each other in a snap-type manner are provided at the contact portion between the rear end portion of the artificial eustachian tube member and the eardrum tube member. Good.

  There is no particular limitation on the specific form for such snap-type engagement between the rear end portion of the artificial ear canal member and the eardrum tube member, and it may be appropriately designed.

  As one specific example of such a snap-type engagement, a flange having a notch on the outer periphery is formed at the rear end portion of the artificial eustachian tube member, and correspondingly, at the rear portion of the tympanic tube member, There may be mentioned one in which at least one projecting portion (rear projecting portion) whose width is slightly widened so as to be snapped into the notch portion is formed in the rearward direction. It is sufficient that the number of notches of the flange is equal to the number of the rear protrusions, but a larger number can be provided, and the range of 1 to 6 is usually sufficient.

  As another specific example of the snap-type engagement, at least one projecting portion (side projecting portion) extending from a part of the outer periphery to the side is formed at the rear end portion of the artificial eustachian tube member. Corresponding to this, there is an example in which a recessed portion that can be accommodated by snapping the side protruding portion into the rear portion of the eardrum tube member is formed. It is sufficient that there are as many recesses as the number of the lateral protrusions, but more recesses can be provided, and usually a range of 1 to 6 is sufficient.

  As another method for mutually engaging the artificial ear canal member and the eardrum tube member, one or a plurality of groups of protrusions are provided on the side surface of the artificial ear canal member, and the artificial ear canal member is used as the eardrum. When passed through the tube member, the tubes and / or their projections pass through the through hole of the eardrum tube member (eg, due to elastic deformation of the artificial ear canal member and / or the eardrum tube member) and when exiting the through hole, the eardrum It can also be configured to snap-engage with the edge of the through hole of the tube member. In this case, the protrusion is a position where the eardrum tube member holds the artificial ear canal member in a form sandwiched between the outer diameter enlarged portion and the protrusion when the protrusion is engaged with the edge of the through hole of the eardrum tube member. (First position) can be provided. The number of protrusions may be one, but along the outer periphery of the artificial eustachian tube member, a plurality of groups of protrusions such as 2, 3, 4, 5, 6, etc. For example, they may be arranged radially.

  In addition, a further protrusion or a group of protrusions may be separated from the first position by a distance that allows the eardrum tube member to be received at a distance (first position). 2), so that the eardrum tube member can hold the artificial ear canal member even in the form of being sandwiched between the protrusions provided at the first and second positions, respectively. By doing so, it is possible to appropriately select the position where the artificial ear canal member is attached to the tympanic membrane tube member from these two positions. Similarly, by providing an additional protrusion or a group of protrusions at a further forward position by the same distance, the additional protrusion and the protrusion positioned immediately behind it are similarly sandwiched between the protrusions. Alternatively, the eardrum tube member may hold the artificial ear canal member. Further, similar projections may be provided at positions where the middle of the section partitioned by these projections is divided (two divisions, three divisions, etc.). In this way, the protrusions are arranged at a narrower pitch along the longitudinal direction of the artificial ear canal member, thereby increasing the options for the position of the eardrum tube member to hold the artificial ear canal member and the length of the patient's ear canal. Accordingly, the depth of insertion of the artificial eustachian tube member can be finely adjusted. As described above, when the protrusions on the artificial ear canal member are arranged at a pitch narrower than the length of the eardrum tube member, the fine adjustment may eventually stay in the through hole of the eardrum tube member. The protuberance can be removed during surgery if necessary. Since the artificial eustachian tube member is made of a flexible material, any protrusion can be easily excised.

  As described above, when one or a plurality of protrusions are provided at a plurality of positions along the front-rear direction of the artificial eustachian tube member, the number of protrusions provided at each position may be appropriately determined for each position. The direction of the protrusions provided at the positions may overlap each other in the front-rear direction between the positions, or may not be (for example, alternate).

  Further, as another method for mutually engaging the artificial ear canal member and the tympanic membrane tube member, one or more groups of one or more groups on the side surface of the artificial ear canal member in front of the outer dimension enlarged portion. Protrusions are provided at a position (first position) where the artificial ear canal member is held in such a manner that the eardrum tube member is sandwiched between the protrusions and the outer enlarged portion of the artificial ear canal member, , A groove (vertical groove) can be formed on the inner peripheral surface of the through hole of the eardrum tube member so that the protrusions can be received and passed back and forth. In this case, when inserting the artificial ear canal member into the eardrum tube member, the protrusion is aligned with the longitudinal groove and passed through the through hole of the eardrum tube member, and after passing through the protrusion, the eardrum tube member is appropriately attached to the artificial ear canal member. By turning this angle, the projection can be engaged with the edge of the through hole away from the position of the longitudinal groove in the circumferential direction. The longitudinal groove is, for example, a groove formed on the inner peripheral surface of the through hole of the eardrum tube and extending linearly back and forth through both ends of the inner peripheral surface. However, since the purpose of forming the longitudinal groove is to provide a passage for the protrusion on the inner peripheral surface of the eardrum tube member, the groove formed in the inner peripheral surface of the eardrum tube member is curved as long as the purpose can be achieved. It may be.

  In addition, a further protrusion or a group of protrusions may be separated from the first position by a distance that allows the eardrum tube member to be received at a distance (first position). 2), and with an arrangement and dimensions that can pass through the longitudinal groove formed in the inner peripheral surface of the through hole of the eardrum tube member, so that the protrusions provided at the first and second positions respectively. The tympanic tube member can also hold the artificial eustachian tube member in a form sandwiched between them. Similarly, a protrusion or a group of protrusions may be additionally provided at a position further forward by the same distance, so that the additional protrusion and a protrusion positioned immediately behind the protrusion may be sandwiched. The tympanic tube member may be capable of holding the artificial eustachian tube member. In addition, similar projections are provided at positions where the middle of the section divided by these projections is divided (two divisions, three divisions, etc.), and the projections are arranged at a narrower pitch along the longitudinal direction of the artificial eustachian tube member. This may be the same as in the above example.

  When providing one or a plurality of protrusions at a plurality of positions along the front-rear direction of the artificial eustachian tube member, the number of protrusions provided at each position (for example, one, two, three, four, five, 6) and the mutual arrangement thereof may be appropriately determined for each position as long as the protrusions can pass through the longitudinal grooves on the inner peripheral surface of the through hole of the eardrum tube member.

  The insertion of the ear canal tympanic tube of the present invention is typically guided through the lumen of the artificial ear canal member from the rear end side with the artificial ear canal member passed through the through hole of the ear drum tube member. Insert the wire into the ear canal while supporting it, pass the tip through the canal, pass the tip to the ear canal, and the eardrum tube crossed the eardrum at its center. Later, it can be done by removing only the guide wire.

  The material constituting the artificial ear canal member and tympanic membrane tube member 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 can be used. As such materials, various materials that are conventionally used for in vivo implantation or indwelling in medical applications may be appropriately used for the production of the artificial ear canal member and the ear canal tube member. Examples of the flexible synthetic resin include, but are not limited to, vinyl chloride, silicone, fluororesin, polyethylene, polypropylene, polypentene, polyurethane resin, and others. A metal (for example, titanium) or a ceramic can be used for a part (for example, the constricted portion). In addition, for artificial eustachian tube members, a resin designed to increase softness when heated to body temperature is easy to handle because it can maintain an appropriate hardness during insertion, but after insertion, the body temperature increases further. Since it becomes soft and there is no possibility of giving a patient a foreign body feeling, it is more preferable as a material constituting an artificial eustachian tube member. Furthermore, by using a biomaterial, for example, autologous cartilage formed by culturing, as a material constituting the artificial eustachian tube member, an artificial eustachian tube member having superior safety can be obtained. Furthermore, in contrast to those stable materials, if it is expected that the treatment can be completed with a relatively short period of insertion of the artificial eustachian member and the subsequent insertion is unnecessary, , It can also be formed of a biodegradable material. Biodegradable materials include, but are not limited to, polylactic acid, polyglycolic acid, and lactic acid / glycolic acid copolymers, cellulose, and gelatin.

  In addition, if desired, the artificial eustachian tube member may be formed of a material that can be inserted into the eustachian tube after impregnating a drug suitable for treatment of the eustachian tube or other antibiotics. An example of such a material is a material obtained by forming the above-described synthetic resin into a porous shape. Further, when the artificial eustachian tube member is formed of a biodegradable material, it may be mixed directly with the biodegradable material itself as long as it is a highly stable drug.

  Hereinafter, the present invention will be described in more detail with reference to typical examples. However, the present invention is not intended to be limited to these examples.

[Example 1]
FIG. 1A is a perspective view of the artificial ear canal member 1 of the ear canal tympanic tube according to the first embodiment. The outer end of the artificial ear canal member 1 is formed outside the remaining portion by forming the flange 3. It is expanding compared to the size. The artificial eustachian tube member 1 has a total length of about 40 mm and is provided with a lumen 5 (shown by a broken line). The lumen 5 opens outward in the axial direction at the front end side opening 7 and the rear end side opening 9. FIG. 1B is a perspective view of the eardrum tube member 10 used integrally with the artificial ear canal member 1 from an oblique rear side. The eardrum tube member 10 includes a front end portion 12, a rear end portion 14, and an intermediate portion 16 positioned therebetween, and a through hole 18 passes through the whole. Since the front end portion 12 and the rear end portion 14 have a larger outer diameter than the intermediate portion 16, the eardrum tube member 10 naturally falls off when attached to the eardrum perforation so as to cross the human eardrum at the intermediate portion 16. hard. The outer diameter of the front end portion 12 is narrowed toward the front so as to be easily fitted into the perforation of the eardrum.

  The artificial eustachian tube member 1 is inserted into the through hole 18 of the eustachian tube member 10 from behind and the perforation or incision provided in the eardrum of the patient from the distal end side with the eustachian tube member 10 passed to the position of the flange 3. The tympanic membrane tube member 10 is fitted to the patient's tympanic membrane at a position where the distal opening faces the inside of the cartilage portion of the ear canal, thereby completing the insertion into the patient. Since the eustachian tube member 10 cannot pass through the through hole 18 of the eardrum tube member 10 attached to the eardrum because of the flange 3 at the rear end, there is no risk of falling into the back of the ear.

[Example 2]

  FIG. 2 is a perspective view of the artificial ear canal member 21 constituting the ear canal tympanic tube according to the second embodiment. The artificial ear canal member 21 includes a lumen 25, a distal end opening 27 opened outward in the axial direction, and a distal side opening 27. A flange 23 including a rear end opening 29 and including a plurality of notches 26 is formed at the rear end. FIG. 3A is a rear end view of the artificial eustachian tube member 21, and six arc-shaped cutouts 26 are provided along the originally circular contour of the flange 23. FIG. 3 (b) is a modification of the flange of FIG. 3 (a), and each notch 26 'reaches the outer peripheral surface (shown by a broken line) of the annular portion of the artificial eustachian tube member. (In this case, the flange is no longer continuous along the outer periphery of the tubular portion, but in this specification, such a configuration is also referred to as a flange including a notch.)

  FIG. 4 is a perspective view of the eardrum tube member 30 used integrally with the artificial ear canal member 21 in the present embodiment from an oblique rear side. The eardrum tube member 30 includes a front end portion 32, a rear end portion 34, and an intermediate portion 36 positioned therebetween, and a through hole 38 passes through them. Further, the rear end portion 34 of the eardrum tube member 30 has a rear protrusion 40 formed on the rear surface thereof. When the artificial ear canal member 21 in this embodiment is passed through the eardrum tube member 30, the rearward projecting portion 40 is fitted into one of the plurality of notches 26 provided in the flange 23 of the artificial ear canal member 21. The position and size can be The rear protrusion 40 has a raised region 42 whose outer diameter slightly bulges in the middle toward the end as compared with its base, and only the outer dimension of this region 42 is within the notch 26 of the flange 23. Slightly larger than the size. For this reason, the rear protrusion 40 is engaged with the notch of the flange 23 in a snap manner, and once engaged, the rear protrusion 40 does not normally separate naturally.

  5 shows that the artificial ear canal member 21 is passed through the through hole 38 of the eardrum tube member 30, and the rear protrusion 40 of the eardrum tube member 30 is fitted into one of the notches 26 of the flange 23 of the artificial ear canal member 21. FIG. 6 is a partial perspective view showing the combined state, and FIG. 6 is a perspective view showing the whole state. Thus, the ear canal tympanic tube comprising the integrated artificial ear canal member 21 and the tympanic tube member 30 is inserted into the patient's ear canal and the rear end portion is attached to the tympanic membrane by the ear drum tube member 30. In the ear canal and tympanic tube according to the present embodiment, the artificial ear canal member 21 has no fear of falling into the back of the ear, and at the same time, the ear canal member is snap-engaged with the eardrum tube member 30, and thus the ear canal. The possibility of falling to the side is also removed.

Example 3
FIG. 7 is a perspective view of an artificial eustachian tube member 51 constituting the eustachian tympanic tube of Example 3, and a pair of projecting portions (side projecting portions) 53 extending laterally are formed at the rear end portion. ing. The shapes and the interrelationships of the lumen 55, the front end side opening 57 and the rear end side opening 59 opened to the outside in the axial direction are the same as those in the first and second embodiments. The artificial eustachian member 51 further includes a lateral hole 58 at a position where it will be placed in the tympanic chamber when the eustachian tympanic tube is inserted. The lateral hole 58 communicates with the lumen 55, and therefore communicates with both the front end side opening 57 and the rear end side opening.

  FIG. 8 is a perspective view of the eardrum tube member 60 used integrally with the artificial ear canal member 51 in the present embodiment from an oblique rear side. The eardrum tube member 60 includes a front end portion 62, a rear end portion 64, and an intermediate portion 66 positioned therebetween, and a through hole 69 passes through them. The rear end portion 64 is formed with a recessed portion 70 that can accommodate the side protruding portion 53 of the artificial eustachian tube member 51. On the surface of the recessed portion 70 is formed a raised portion 72 that must be overcome when the side protruding portion 53 of the artificial eustachian tube member 50 passes in the front-rear direction, and the side protruding portion 53, the recessed portion 70, Can be snapped into engagement.

  FIG. 9 is a perspective view from the rear just before the artificial ear tube member 51 is passed through the through-hole 69 of the eardrum tube member 60. FIGS. 10 and 11 are integrated by snapping them together. FIG. 2 is a partial perspective view and an overall perspective view, respectively, of the state. In the ear canal and tympanic tube of the present embodiment, the artificial ear canal member 51 does not have a risk of falling into the back of the ear, and at the same time, the ear canal member 51 snaps into engagement with the eardrum tube member 60 at the rear end. The possibility of falling to the side is also removed.

Example 4
FIG. 12 is a perspective view showing a modification of the third embodiment. In the present embodiment, the prosthetic eustachian member 51 is different from the structure of the third embodiment in that the distal end is a blind end and the distal end side opening 57 'is provided on the side of the distal end portion. .

Example 5
FIG. 13 is a perspective view of the artificial eustachian member 1a constituting the eustachian tympanic tube of Example 5, which is different from the artificial eustachian member 1 shown in FIG. , 81 are different only in that they are provided. The protrusion 80 is provided at a position away from the flange by a distance that allows the eardrum tube member to be sandwiched between the flange 3 and the prosthetic ear canal member 1a as the eardrum tube member (for example, 10 in FIG. 1). , It can be engaged with the edge of the through hole of the eardrum tube member. The apex of the protrusion slightly protrudes from the inner diameter of the through hole (for example, 18 in FIG. 1) of the eardrum tube member, but when inserting the artificial ear canal member 1a into the through hole of the eardrum tube member, Or it can retreat by both elastic deformations and can pass through a through-hole. After the passage, the projection 80 returns to the original position and engages with the edge of the through hole of the eardrum tube member, so that the artificial ear canal member 1a is more stable between the flange 3 and the projection 80 by the eardrum tube member. Held. The protrusion 81 provided on the distal end side of the protrusion 80 has the same configuration as the protrusion 80 and is arranged away from the protrusion 80 by a distance that allows the tympanic membrane tube member to be sandwiched between the protrusions 80. Therefore, the artificial ear canal member 1a can be stably held by the eardrum tube member even between the protrusions 80 and 81.

Example 6
FIG. 14 is a perspective view of an artificial eustachian tube member 51a constituting the eustachian tympanic tube of Example 6, which is different from the artificial eustachian tube member 51 shown in FIG. The only difference is that 87 is provided. The structure of these protrusions is the same as that of the fifth embodiment. In this embodiment, since the protrusion 87 on the front side is further provided, the artificial ear canal member 51a stabilizes the eardrum tube member at a position further forward than in the case of the embodiment 5, that is, between the protrusions 86 and 87. And hold it.

Example 7
In FIG. 15, (a) is a perspective view of an artificial ear canal member 1b constituting the ear canal tympanic tube of Example 7, and (b) is an ear drum tube member used integrally with the artificial ear canal member 1b. It is a perspective view from diagonally backward of 10b. The artificial eustachian member 1b differs from the artificial eustachian tube member 1 shown in FIG. 1 (a) only in that projections 90, 91, and 92 are provided on the side surfaces in this embodiment. These protrusions can be slightly larger than the protrusions of Example 6 because the following longitudinal grooves can be used to pass through the through-holes of the eardrum tube member. Also. The eardrum tube member 10b differs from the eardrum tube member 10 shown in FIG. 1 (b) only in that a pair of longitudinal grooves (vertical grooves) 95 are formed in this embodiment. The protrusion 90 of the artificial eustachian tube member 10 b is disposed away from the flange 3 by a distance that allows the eardrum tube member 10 b to be sandwiched between the protrusion 3 and the flange 3. The positional relationship before and after the projections 90 and 91 and the projections 91 and 92 is the same. The longitudinal groove 95 of the eardrum tube member 10b has a cross section with a size that allows the projections 90, 91, and 92 to pass therethrough. In the present embodiment, the tympanic membrane tube member 10 b can arbitrarily take any position between the flange 3 and the protrusions 90, 91 and 92 by passing the protrusion through the vertical groove 95. By appropriately rotating the artificial ear canal member 1b at that position and separating the protrusion in the circumferential direction from the position of the longitudinal groove, the protrusion adjacent to the tympanic tube member cannot pass through the longitudinal groove. Held by the tympanic membrane member.

  According to the present invention, effective and simple treatment of a floppy tube that causes ureteral stenosis, ureteral canalism or both obstruction and opening, treatment of adhesive otitis media, prevention of tympanic membrane adhesion after exudative otitis media surgery It is possible to provide a type of artificial eustachian tube that can be used to prevent recurrence of pearls and pearls and has excellent positional stability while being inserted into the patient's ear.

1, 1a, 1b: Artificial eustachian tube member 3: Flange 5: Lumen 7: Front end side opening 9: Rear end side opening 10, 10b: Tympanic membrane tube member 12: Front end portion 14: Rear end portion 16: Intermediate portion 18: Through hole 21: Artificial eustachian member 23: Flange 25: Lumen 26: Notch 27: Front end side opening 29: Rear end side opening 30: Tympanic membrane tube member 32: Front end portion 34: Rear end portion 36: Intermediate portion 38: Through hole 40: Backward projecting portion 42: Raised region 51, 51a: Artificial ear canal member 53: Side projecting portion 55: Lumen 57, 57 ': Front side opening 58: Lateral hole 59: Rear end side opening 60: Tympanic tube Member 62: Front end portion 64: Rear end portion 66: Intermediate portion 69: Through hole 70: Recessed portion 72: Raised portion 80, 81, 85, 86, 87, 90, 91, 92: Projection 95: Vertical groove

Claims (15)

The front end portion and the rear end portion are connected to each other by a through-hole including a central portion having a relatively small outer size and a front end portion and a rear end portion having relatively large outer dimensions, which are mounted across the tympanic membrane. A tympanic membrane tube member which is a short tubular member,
To be inserted out of the eardrum in the external auditory canal through the tip for insertion into the ear canal from the tympanic chamber side and facing the cartilage part through the ear canal and into the ear canal through the through hole of the eardrum tube member mounted across the eardrum An elongate tube having a rear end and an artificial eustachian tube member having a rear end opening and at least one distal opening, the openings being in communication by a lumen An ear canal tympanic tube comprising a rear end portion of the artificial eustachian tube member having an outer dimension enlarged portion which is a portion having an outer dimension larger than the inner diameter of the through hole of the tympanic membrane tube member.   2. The eustachian tube according to claim 1, wherein the distal end portion of the artificial eustachian tube member includes a region made of a material or a sieve-like structure that allows movement of air and / or water instead of the distal end side opening. Tympanic tube.   The ear canal tympanic tube according to claim 1 or 2, wherein the outer dimension enlarged portion is an enlarged portion of the outer diameter of the artificial ear canal member.   The ear according to claim 1 or 2, wherein the outer dimension enlarged portion is formed by a flange formed at the rear end portion or at least one projecting portion extending laterally from a part of the outer periphery of the rear end portion. Tympanic membrane tube.   The outer dimension enlarged portion is a flange formed at a rear end portion of the artificial eustachian tube member, the flange includes at least one notch portion, and the eardrum tube member is snapped into the notch portion. The ear tympanic tube according to claim 4, wherein a rearwardly projecting portion capable of engaging with the rear end portion is provided at the rear end portion.   The outer dimension enlarged portion is formed by at least one projecting portion extending laterally from a part of the outer periphery of the rear end portion of the artificial eustachian tube member, and the eardrum tube member snaps the projecting portion. The ear canal tympanic tube according to claim 4, wherein the rear end portion is provided with a recess having a shape to be accommodated.   The ear canal tympanic tube according to any one of claims 1 to 6, wherein the artificial ear canal member has a lateral hole on a side surface thereof that communicates the lumen of the tube and the outside of the tube.   At least one protrusion is formed on the side surface of the artificial ear canal member in front of the outer dimension enlarged portion, and when the artificial ear tube member is passed through the through hole of the eardrum tube member, the eardrum tube member is the protrusion. And the outer dimension enlarged portion are provided at a first position which is a position allowing the artificial ear canal member to be held in a shape sandwiched between the outer dimension enlarged portion, and the protrusion is provided on the eardrum tube member. The ear canal tympanic tube according to any one of claims 1 to 7, which is configured to be able to pass through the through hole and to be snap-engaged with an edge of the through hole.   9. The ear canal tympanic tube according to claim 8, wherein 1 to 6 protrusions are provided along the outer periphery of the artificial ear canal member.   In front of the first position, at least one additional protrusion on the side of the prosthetic eustachian tube member, the tympanic tube member being sandwiched between the additional protrusion and the protrusion in the first position A second position which is a position that allows the artificial ear canal member to be held in an open shape, the additional protrusion being able to pass through the through hole of the eardrum tube member and The ear tympanic tube according to claim 8 or 9, wherein the edge of the through hole is configured to be engaged in a snap-type manner.   The ear canal tympanic tube according to claim 10, wherein 1 to 6 of the further protrusions are provided along the outer periphery of the artificial ear canal member.   At least one protrusion is formed on the side surface of the artificial ear canal member in front of the outer dimension enlarged portion, and when the artificial ear tube member is passed through the through hole of the eardrum tube member, the eardrum tube member is the protrusion. And the outer dimension enlarged portion are provided at a first position which is a position allowing the artificial ear canal member to be held in a shape sandwiched between the outer dimension enlarged portion and the through hole of the eardrum tube member. 8. The ear canal tympanic tube according to any one of claims 1 to 7, wherein a longitudinal groove capable of receiving the protrusion and allowing it to pass back and forth is formed on the inner peripheral surface.   13. The ear canal tympanic tube according to claim 12, wherein 1 to 6 protrusions are provided along the outer periphery of the artificial eustachian tube member.   In front of the first position, at least one additional protrusion on the side of the prosthetic eustachian tube member, the tympanic tube member being sandwiched between the additional protrusion and the protrusion in the first position And the additional protrusion is formed on the inner peripheral surface of the through hole of the eardrum tube member. The tubal tympanic tube according to claim 12 or 13, which can pass back and forth through the longitudinal groove. The ear canal tympanic tube according to claim 14, wherein 1 to 6 further protrusions are provided along the outer periphery of the artificial ear canal member.

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