WO2006118072A1 - Canal auditif artificiel - Google Patents

Canal auditif artificiel Download PDF

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Publication number
WO2006118072A1
WO2006118072A1 PCT/JP2006/308532 JP2006308532W WO2006118072A1 WO 2006118072 A1 WO2006118072 A1 WO 2006118072A1 JP 2006308532 W JP2006308532 W JP 2006308532W WO 2006118072 A1 WO2006118072 A1 WO 2006118072A1
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WO
WIPO (PCT)
Prior art keywords
ear canal
artificial
canal
artificial ear
opening
Prior art date
Application number
PCT/JP2006/308532
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English (en)
Japanese (ja)
Inventor
Masahiro Morita
Original Assignee
Masahiro Morita
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Masahiro Morita filed Critical Masahiro Morita
Priority to JP2007514708A priority Critical patent/JP5192231B2/ja
Publication of WO2006118072A1 publication Critical patent/WO2006118072A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/18—Internal ear or nose parts, e.g. ear-drums
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/18—Internal ear or nose parts, e.g. ear-drums
    • A61F2002/183—Ear parts

Definitions

  • 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.
  • 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).
  • the eustachian tube 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.
  • 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.
  • the tympanic chamber 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.
  • Eustachian tube ventilation therapy 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.
  • 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.
  • 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.
  • 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.
  • eustachian tube is a condition in which the eustachian tube is always open.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • it can also cause exudative otitis media, adhesive otitis media, and cholesteatoma otitis media when placed under negative pressure.
  • 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.
  • 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.
  • 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).
  • 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.
  • a constricted part or a protrusion in front of the constricted part
  • a 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
  • 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.
  • 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.
  • 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.
  • the present invention provides the following.
  • 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.
  • 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.
  • the lumen is open to the outside through at least one posterior opening
  • An artificial eustachian tube characterized by that.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • an artificial ear canal that can be used to prevent recurrence of the exudate and has a further enhanced exudate excretion function.
  • 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. 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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”.
  • “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.
  • the groups of adjacent front and rear protrusions may be equally spaced or unevenly spaced.
  • 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.
  • 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.
  • 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.
  • 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.
  • the shape of the projecting portion should not be sharp or angular so as not to damage the tissue.
  • 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:
  • wart-shaped protrusion it is preferable to eliminate a sharp corner by rounding the tip even in a conical or pyramidal shape.
  • These protrusions may be flexible.
  • 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.
  • 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.
  • 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.
  • the upper edge has a plurality of cutouts, the artificial ear canal can be fixed by the cutouts. It may be reduced.
  • these protrusions may be flexible.
  • the protrusion is a rod-shaped protrusion protruding from the outer peripheral surface force.
  • 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.
  • 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.
  • 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! /.
  • 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.
  • 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.
  • the distal end or the vicinity thereof e.g., the distal end
  • the distal end or the vicinity thereof is narrowed by 0.2 mm or more from the diameter of the lumen.
  • 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.
  • the number of openings may be one, but a plurality of openings may be provided.
  • a pair of openings may be provided on both sides of the lumen.
  • 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.
  • the posterior opening 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.
  • 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.
  • Such an additional opening can be provided separately from the rear opening.
  • the additional opening is integrated with the rear opening. You can do it.
  • 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.
  • 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.
  • 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. .
  • the inner diameter 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.
  • 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 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.
  • 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.
  • 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.
  • 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!
  • 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.
  • 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 ⁇ .
  • a metal (for example, titanium) or a ceramic can be used for a part (for example, the constricted portion).
  • 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.
  • autologous cartilage formed by culturing as a biomaterial, it is possible to obtain an artificial ear canal having superior safety.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the height of the protrusion 7 is somewhat exaggerated in the figure.
  • 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.
  • the tips are arranged so that the tip height decreases (taperes) toward the tip of the artificial ear canal.
  • 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.
  • 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.
  • 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.
  • 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
  • Length of constricted part 9 1.5 to 2.5 mm
  • the outer diameter of the constricted portion 9 is 1.30-1.35 mm
  • 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.
  • FIG. 2 is a plan view showing a slightly backward force of another embodiment of the artificial ear canal of the present invention.
  • 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.
  • 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.
  • opening 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.
  • 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.
  • 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.
  • FIG. 3 is a plan view of a further embodiment of the present invention as seen from the rear side.
  • 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.
  • 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.
  • 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.
  • flow paths in various directions are provided.
  • 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.
  • 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.
  • FIG. 4 is a plan view of another embodiment of the present invention as seen from the rear.
  • 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.
  • 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.
  • 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.
  • 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.
  • protrusions 37 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.
  • 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 .
  • 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.
  • FIG. 5 is a plan view of a further embodiment of the present invention as seen from the rear side.
  • 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.
  • 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.
  • opening 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.
  • 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.
  • 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.
  • the tips are arranged such that the tip height decreases (taperes) toward the tip side 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 .
  • 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.
  • 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.
  • 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.
  • 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.
  • passive open pressure or reverse ventilation pressure 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.
  • active opening active opening
  • the ear canal is passively expanded and opened (passive expansion).
  • 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.
  • the eustachian function test device ET manufactured by Nagashima Medical Instruments Co., Ltd. 1000 was used (conceptually shown in Figure 7).
  • 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.
  • 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.
  • 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.
  • 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.
  • an increase in middle ear pressure is usually observed at a ventilation pressure of about 8 kPa.
  • 161 is an external auditory canal pressure sensor
  • 162 is an ear canal catheter
  • 163 is a ventilation pressure sensor.
  • the aeration pressure at point A is the open canal pressure (kPa).
  • 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
  • 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.

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  • Health & Medical Sciences (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L’invention concerne un canal auditif artificiel à insérer et à placer dans le canal auditif d'un patient pour normaliser le flux d'air et d'exsudat entre le côté cavité tympanique et le côté cavité nasal, qui peut être complètement enseveli et montrer une efficacité élevée de décharge de l'exsudat de la cavité tympanique vers le côté cavité nasal. Ce canal auditif artificiel possède une extrémité avant, une extrémité arrière et une lumière. Son extrémité avant est introduite depuis le canal auditif dans la partie côté osseux vers le canal auditif dans la partie côté cartilagineux en passant par la partie étroite du canal auditif afin que le canal auditif artificiel soit retenu sur la partie étroite du canal auditif et donc retenu dans celui-ci. Le canal auditif artificiel est caractérisé en ce qu'il possède une pluralité de projections réparties à la périphérie externe sur la face périphérique au moins dans la partie qui est retenue sur la partie étroite du canal auditif. Dans cette partie et/ou une partie côté extrémité avant du canal auditif artificiel, la lumière s’ouvre vers l’extérieur depuis au moins une ouverture côté extrémité avant, et la lumière s’ouvre vers l’extérieur depuis au moins une ouverture côté extrémité arrière, située postérieurement à la partie décrite ci-avant.
PCT/JP2006/308532 2005-04-28 2006-04-24 Canal auditif artificiel WO2006118072A1 (fr)

Priority Applications (1)

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JP2007514708A JP5192231B2 (ja) 2005-04-28 2006-04-24 人工耳管

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JP2005-130946 2005-04-28
JP2005130946 2005-04-28

Publications (1)

Publication Number Publication Date
WO2006118072A1 true WO2006118072A1 (fr) 2006-11-09

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PCT/JP2006/308532 WO2006118072A1 (fr) 2005-04-28 2006-04-24 Canal auditif artificiel

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109350359A (zh) * 2018-11-13 2019-02-19 佛山市第人民医院（中山大学附属佛山医院） 一种咽鼓管吸引器
RU2777241C1 (ru) * 2022-03-28 2022-08-01 Федеральное Государственное Бюджетное Учреждение "Национальный Медицинский Исследовательский Центр Оториноларингологии Федерального Медико-Биологического Агентства" (Фгбу Нмицо Фмба России) Способ хирургического удаления холестеатомы пирамиды височной кости

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4015607A (en) * 1976-01-23 1977-04-05 Wright Iii J William Eustachian tube prosthesis and method for its implantion
JP2002224157A (ja) * 2001-02-06 2002-08-13 Koken Co Ltd 耳管ピン
WO2003022192A1 (fr) * 2001-09-12 2003-03-20 Jason Litner Extenseur pour trompe d'eustache

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4015607A (en) * 1976-01-23 1977-04-05 Wright Iii J William Eustachian tube prosthesis and method for its implantion
JP2002224157A (ja) * 2001-02-06 2002-08-13 Koken Co Ltd 耳管ピン
WO2003022192A1 (fr) * 2001-09-12 2003-03-20 Jason Litner Extenseur pour trompe d'eustache

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109350359A (zh) * 2018-11-13 2019-02-19 佛山市第人民医院（中山大学附属佛山医院） 一种咽鼓管吸引器
RU2777241C1 (ru) * 2022-03-28 2022-08-01 Федеральное Государственное Бюджетное Учреждение "Национальный Медицинский Исследовательский Центр Оториноларингологии Федерального Медико-Биологического Агентства" (Фгбу Нмицо Фмба России) Способ хирургического удаления холестеатомы пирамиды височной кости

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JPWO2006118072A1 (ja) 2008-12-18

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