JP6434921B2 - Voice disorder treatment device - Google Patents
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- JP6434921B2 JP6434921B2 JP2015558759A JP2015558759A JP6434921B2 JP 6434921 B2 JP6434921 B2 JP 6434921B2 JP 2015558759 A JP2015558759 A JP 2015558759A JP 2015558759 A JP2015558759 A JP 2015558759A JP 6434921 B2 JP6434921 B2 JP 6434921B2
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- 208000011293 voice disease Diseases 0.000 title description 2
- 229910052719 titanium Inorganic materials 0.000 claims description 109
- 239000010936 titanium Substances 0.000 claims description 109
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims description 108
- 210000000534 thyroid cartilage Anatomy 0.000 claims description 101
- 210000001260 vocal cord Anatomy 0.000 claims description 66
- 208000027765 speech disease Diseases 0.000 claims description 36
- 206010013952 Dysphonia Diseases 0.000 claims description 30
- 230000037418 vocal dysfunction Effects 0.000 claims description 23
- 238000005452 bending Methods 0.000 claims description 12
- 230000001225 therapeutic effect Effects 0.000 claims description 6
- 239000007943 implant Substances 0.000 description 31
- 238000001356 surgical procedure Methods 0.000 description 26
- 239000000463 material Substances 0.000 description 12
- 238000000034 method Methods 0.000 description 12
- 239000012528 membrane Substances 0.000 description 10
- 210000000867 larynx Anatomy 0.000 description 9
- 208000010473 Hoarseness Diseases 0.000 description 7
- 239000004677 Nylon Substances 0.000 description 7
- 239000012634 fragment Substances 0.000 description 7
- 229920001778 nylon Polymers 0.000 description 7
- 206010033799 Paralysis Diseases 0.000 description 5
- 210000000845 cartilage Anatomy 0.000 description 5
- 230000007774 longterm Effects 0.000 description 5
- 206010003694 Atrophy Diseases 0.000 description 4
- 208000005248 Vocal Cord Paralysis Diseases 0.000 description 4
- 230000037444 atrophy Effects 0.000 description 4
- 210000005036 nerve Anatomy 0.000 description 4
- 208000021090 palsy Diseases 0.000 description 4
- 230000000306 recurrent effect Effects 0.000 description 4
- 230000029058 respiratory gaseous exchange Effects 0.000 description 4
- 210000001685 thyroid gland Anatomy 0.000 description 4
- 208000019505 Deglutition disease Diseases 0.000 description 3
- 206010028980 Neoplasm Diseases 0.000 description 3
- 230000032683 aging Effects 0.000 description 3
- 201000011510 cancer Diseases 0.000 description 3
- 238000010586 diagram Methods 0.000 description 3
- 208000014674 injury Diseases 0.000 description 3
- 210000003800 pharynx Anatomy 0.000 description 3
- 229920001296 polysiloxane Polymers 0.000 description 3
- 238000007665 sagging Methods 0.000 description 3
- 210000003296 saliva Anatomy 0.000 description 3
- 239000002356 single layer Substances 0.000 description 3
- 210000003437 trachea Anatomy 0.000 description 3
- 230000008733 trauma Effects 0.000 description 3
- 229920000544 Gore-Tex Polymers 0.000 description 2
- 230000003187 abdominal effect Effects 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 208000035475 disorder Diseases 0.000 description 2
- 210000004704 glottis Anatomy 0.000 description 2
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 2
- 239000004810 polytetrafluoroethylene Substances 0.000 description 2
- QQJLHRRUATVHED-UHFFFAOYSA-N tramazoline Chemical compound N1CCN=C1NC1=CC=CC2=C1CCCC2 QQJLHRRUATVHED-UHFFFAOYSA-N 0.000 description 2
- 229960001262 tramazoline Drugs 0.000 description 2
- 230000001755 vocal effect Effects 0.000 description 2
- 206010067171 Regurgitation Diseases 0.000 description 1
- 230000005856 abnormality Effects 0.000 description 1
- 239000002473 artificial blood Substances 0.000 description 1
- 108010045569 atelocollagen Proteins 0.000 description 1
- 239000000560 biocompatible material Substances 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 239000002639 bone cement Substances 0.000 description 1
- 230000006735 deficit Effects 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 230000004064 dysfunction Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 229910052588 hydroxylapatite Inorganic materials 0.000 description 1
- 238000007373 indentation Methods 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 238000010330 laser marking Methods 0.000 description 1
- 238000002690 local anesthesia Methods 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000011527 multiparameter analysis Methods 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 1
- -1 polytetrafluoroethylene Polymers 0.000 description 1
- 239000002436 steel type Substances 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 150000003608 titanium Chemical class 0.000 description 1
- 208000023180 voice disturbance Diseases 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/24—Surgical instruments, devices or methods, e.g. tourniquets for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers
-
- 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
- A61F2/20—Epiglottis; Larynxes; Tracheae combined with larynxes or for use therewith
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0045—Omega-shaped
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Surgery (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Pulmonology (AREA)
- Public Health (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Veterinary Medicine (AREA)
- Otolaryngology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Transplantation (AREA)
- Vascular Medicine (AREA)
- Dentistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Cardiology (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Prostheses (AREA)
- Surgical Instruments (AREA)
Description
本発明は、発声障害治療具に関する。 The present invention relates to a speech disorder treatment device.
声帯は、咽頭の上部（前部）にある発声するための器官であり、開閉する左右一対の声帯襞の間の隙間に、肺から排出される空気を通過させ、振動を引き起こすことにより音（声）を発する。このような声帯の運動を支配しているのは、反回神経である。反回神経麻痺（声帯麻痺）、外傷、癌の手術、加齢等により、一側の声帯が正中位（閉塞位）への内転障害をきたし、あるいは全体に萎縮して、声門閉鎖不全の状態となると、息漏れや嗄声（気息性嗄声）による音声障害、食物や唾液の気管への垂れ込みによる嚥下障害などが生じる。
このような声門閉鎖不全を改善するための手術としては、麻痺側（患側）声帯に自家組織（脂肪）や異物（骨ペースト、アテロコラーゲン）を注入して体積を増し間隙を矯正する手術と、皮膚に外切開を加え、切開した甲状軟骨板経由に声帯を内方に押し込み間隙を矯正する手術（保険手技名：喉頭形成術）とがある。The vocal cord is an organ for vocalization in the upper part (anterior part) of the pharynx, and the sound (by causing the air discharged from the lungs to pass through the gap between a pair of left and right vocal folds that open and close, causing vibration ( Voice). It is the recurrent nerve that controls such vocal cord movement. Due to recurrent nerve palsy (glottic palsy), trauma, cancer surgery, aging, etc., one side of the vocal fold may be abducted to the median position (obstructed position), or it may atrophy overall, resulting in glottal insufficiency When this happens, voice disturbance due to breath leakage and hoarseness (breathing hoarseness), dysphagia due to sagging food and saliva in the trachea, and the like occur.
Surgery to improve such glottal insufficiency includes surgery to inject autologous tissue (fat) or foreign matter (bone paste, atelocollagen) into the paralyzed side (affected side) vocal cords to increase the volume and correct the gap, There is an operation (insurance technique name: laryngeoplasty) in which an external incision is made and a vocal cord is pushed inward through the incised thyroid cartilage plate to correct the gap.
従来より、患側声帯を内方に押し込んだ状態で固定するためには自家軟骨やインプラントが用いられている。前記インプラントとしては様々な材料が用いられている。前記喉頭形成術が考案された当初はシリコーンブロックを削り出してインプラントとして用いていた。しかし、前記シリコーンブロックは、医療機器として認可されておらず安全性の点で問題があるため、徐々に使用されなくなってきている。
前記シリコーンブロックに代わって用いられるようになってきたのが、ゴアテックス（Ｒ）に代表されるポリテトラフルオエチレン（ＰＴＦＥ）シートを折り畳んで挿入する方法である。前記ゴアテックス（Ｒ）は、人工血管にも使用されている生体適合性の高い材料であり、日本国内では最も使用されているが、固定素材としては軟らかく適切な位置での固定が困難な場合がある。また、一部の施設では人工骨材料であるハイドロキシアパタイトを成形したものを使用している。Conventionally, autologous cartilage and implants have been used to fix the affected vocal folds while being pushed inward. Various materials are used as the implant. When the laryngeoplasty was devised, the silicone block was cut out and used as an implant. However, since the silicone block is not approved as a medical device and has a problem in safety, it is gradually not used.
In place of the silicone block, a method of folding and inserting a polytetrafluoroethylene (PTFE) sheet represented by Gore-Tex (R) has been used. The Gore-Tex (R) is a highly biocompatible material that is also used in artificial blood vessels and is most used in Japan, but it is soft as a fixing material and difficult to fix at an appropriate position. There is. Some facilities use hydroxyapatite, which is an artificial bone material.
一方、チタンは、生体親和性が高く、適度な硬度を有しており、固定素材として適している。例えば、オーストリアのフリードリッヒ（Ｆｒｉｅｄｒｉｃｈ）がチタン製インプラントについて報告している（非特許文献１参照）。前記フリードリッヒのインプラントの鋼種は、ＡＳＴＭＦ６７．Ｇｒａｄｅ４（ＪＩＳ Ｈ４６００ ４種に相当）の純チタンであり、厚みは０．２５ｍｍである。図１Ａ及び図１Ｂは、前記フリードリッヒの論文から抜粋した図である。図１Ａはフリードリッヒのインプラントの写真、図１Ｂはフリードリッヒのインプラントを甲状軟骨に取り付けた状態を示す写真である。 On the other hand, titanium has a high biocompatibility and an appropriate hardness, and is suitable as a fixing material. For example, Friedrich of Austria reports on a titanium implant (see Non-Patent Document 1). The steel type of the Friedrich implant is ASTM F67. Grade 4 (corresponding to 4 types of JIS H4600) pure titanium, and the thickness is 0.25 mm. 1A and 1B are diagrams extracted from the Friedrich paper. FIG. 1A is a photograph of a Friedrich implant, and FIG. 1B is a photograph showing a state where the Friedrich implant is attached to thyroid cartilage.
しかし、前記フリードリッヒのインプラントには、以下の課題乃至問題点がある。
（１）前方（前交連）の押込量の調節ができない。
前記フリードリッヒのインプラントは、厚みが０．２５ｍｍと厚く、ＡＳＴＭＦ６７．Ｇｒａｄｅ４（ＪＩＳ Ｈ４６００ ４種に相当）の高い強度を有しており、インプラントの前方が調節可能な形状では無い。このため、個人差が大きい甲状軟骨の形状に十分対応できないという課題がある。例えば、図２中の矢印で示すように、フリードリッヒのインプラント１が、声帯１４の前方を押し足りなければ気息性嗄声が改善しない。一方、フリードリッヒのインプラント１が、声帯１４の前方を押し過ぎてしまうと詰まった音声になってしまう。However, the Friedrich implant has the following problems or problems.
(1) The amount of pushing forward (front commissure) cannot be adjusted.
The Friedrich implant has a thickness of 0.25 mm and is ASTM F67. It has a high strength of Grade 4 (corresponding to 4 types of JIS H4600), and the front of the implant is not an adjustable shape. For this reason, there exists a subject that it cannot fully respond to the shape of a thyroid cartilage with a large individual difference. For example, as indicated by the arrow in FIG. 2, if the Friedrich's implant 1 does not push forward in front of the vocal cord 14, breathing hoarseness is not improved. On the other hand, if the Friedrich's implant 1 pushes the front of the vocal cord 14 too much, the sound becomes clogged.
（２）押込部の長さ（幅）が調節できない。
声帯において実際に発声に関与するのは声帯膜様部と呼ばれる前２／３の部位である。この声帯膜様部の長さは成人で１２ｍｍ〜１８ｍｍと幅があり、声帯麻痺による声帯の弓状変化（一般的に萎縮と言われている）の程度も様々である。図３中の矢印で示すように、押込部の長さ（幅）が一定であるフリードリッヒのインプラント１ではその個人差に十分に対応できないという課題がある。(2) The length (width) of the pushing part cannot be adjusted.
What is actually involved in vocalization in the vocal cords is the front 2/3 region called the vocal cord membrane-like part. The length of the vocal cord membrane-like part is as wide as 12 mm to 18 mm in an adult, and the degree of arcuate change (generally referred to as atrophy) due to vocal cord paralysis varies. As indicated by the arrows in FIG. 3, there is a problem that the Friedrich implant 1 in which the length (width) of the pushing portion is constant cannot sufficiently cope with individual differences.
（３）声帯と平行に圧迫することが困難である。
甲状軟骨の腹側（前側）と背側（後側）では声帯に対する角度が異なり、図４Ａ及び図４Ｂに示すように声帯膜様部前方では声帯と甲状軟骨がほぼ平行である（図４Ｂ中点線参照）が、図４Ｃ及び図４Ｄに示すように声帯膜様部後方では声帯と甲状軟骨が平行ではない（図４Ｄ中点線参照）。図５中の矢印で示すように、前記フリードリッヒのインプラント１の両端は甲状軟骨の外側に露呈しており、前記フリードリッヒのインプラント１は、甲状軟骨の背側（後側）で一つの取付孔にナイロン糸を通して固定している。この場合、声帯膜様部後方では甲状軟骨は声帯と平行でないため、声帯膜様部後方で前記フリードリッヒのインプラント１を固定すると、前記インプラント１が傾いてしまって声帯１４を平行に圧迫できないという課題がある。
このことは、非特許文献２に掲載されている図６Ａ及び図６Ｂから明らかである。即ち、図６Ａは前記フリードリッヒのインプラントを甲状軟骨に取り付ける前の写真、図６Ｂは前記フリードリッヒのインプラントを甲状軟骨に取り付けた後の写真をそれぞれ示す。図６Ｂのフリードリッヒのインプラントを甲状軟骨に取り付けた後は、図６Ａのインプラントを取り付け前に比べて、声帯より下方が押し出されており、前記フリードリッヒのインプラントは声帯を平行に圧迫できていないことが明らかである。(3) It is difficult to press in parallel with the vocal cords.
The angle to the vocal cord is different between the ventral side (front side) and the back side (rear side) of the thyroid cartilage, and the vocal cord and thyroid cartilage are almost parallel in front of the vocal cord membrane-like part as shown in FIGS. 4A and 4B (in FIG. 4B). As shown in FIGS. 4C and 4D, the vocal cord and the thyroid cartilage are not parallel behind the vocal cord membrane-like part (see the dotted line in FIG. 4D). As shown by arrows in FIG. 5, both ends of the Friedrich implant 1 are exposed to the outside of the thyroid cartilage, and the Friedrich implant 1 has a single attachment hole on the back side (back side) of the thyroid cartilage. It is fixed through nylon thread. In this case, since the thyroid cartilage is not parallel to the vocal cord behind the vocal cord membrane-like part, if the Friedrich's implant 1 is fixed behind the vocal cord membrane-like part, the implant 1 is inclined and cannot press the vocal cord 14 in parallel. There is.
This is apparent from FIGS. 6A and 6B published in Non-Patent Document 2. 6A shows a photograph before the Friedrich's implant is attached to thyroid cartilage, and FIG. 6B shows a photograph after the Friedrich's implant is attached to thyroid cartilage. After the Friedrich's implant of FIG. 6B is attached to the thyroid cartilage, the lower part of the vocal cord is pushed out compared to before the attachment of FIG. 6A, and the Friedrich's implant cannot press the vocal cord in parallel. it is obvious.
本発明者は、先に、患側甲状軟骨翼を窓状に切開し、切開した甲状軟骨片を内方に圧排し、患側声帯を内方に移動させる術式である甲状軟骨形成術Ｉ型において、切開した甲状軟骨片の固定にチタンプレートを用いることの有用性について報告している（非特許文献３参照）。この論文は、甲状軟骨形成術Ｉ型においてチタンプレートを用い甲状軟骨片の固定を行った国内最初の報告である。
この非特許文献３のチタンプレート（以下、「旧チタンプレート」と称する）１０は、図７に示すように、予め一端をクランク状に折曲加工してなり、長さ２０ｍｍ、幅５ｍｍ、厚み０．２ｍｍであり、クランク側の端部に直径２ｍｍの取付孔１１を有している。この前記旧チタンプレート１０は、図８に示すように、前記旧チタンプレート１０のクランク側の端部を甲状軟骨上で取付孔１１にナイロン糸を通して固定している。一方、前記旧チタンプレート１０の他端は、甲状軟骨１３と甲状軟骨片１２との間に配置され内側から甲状軟骨に当接している。なお、必要に応じて前記旧チタンプレート１０を湾曲させて、甲状軟骨片１２の内方移動の程度を調節することができる。The present inventor previously incised the affected thyroid cartilage wing in a window shape, squeezed the incised thyroid cartilage piece inward, and moved the affected vocal fold inward in thyroid chondroplasty type I The usefulness of using a titanium plate to fix an incised thyroid cartilage fragment has been reported (see Non-Patent Document 3). This paper is the first report in Japan to fix thyroid cartilage fragments using a titanium plate in thyroid chondroplasty type I.
The titanium plate (hereinafter referred to as “old titanium plate”) 10 of Non-Patent Document 3 is formed by bending one end in a crank shape in advance as shown in FIG. 7, and has a length of 20 mm, a width of 5 mm, and a thickness. The mounting hole 11 has a diameter of 2 mm at the end on the crank side. As shown in FIG. 8, the old titanium plate 10 has an end on the crank side of the old titanium plate 10 fixed to the attachment hole 11 through a nylon thread on the thyroid cartilage. On the other hand, the other end of the old titanium plate 10 is disposed between the thyroid cartilage 13 and the thyroid cartilage piece 12 and is in contact with the thyroid cartilage from the inside. If necessary, the old titanium plate 10 can be bent to adjust the degree of inward movement of the thyroid cartilage piece 12.
しかしながら、前記旧チタンプレート１０は、窓状に切開した甲状軟骨片１３を押し込む目的で使用しているため、手術後切開した甲状軟骨片が薄くなって声門間隙が広がる傾向があるという課題がある。
また、前記旧チタンプレート１０は、固定部の中央に直径２ｍｍの取付孔１１を設け、前記取付孔１１に前記ナイロン糸を通して甲状軟骨１３に固定している。この固定に用いる２−０サイズ（太さ０．２ｍｍ程度）の前記ナイロン糸に比べて前記旧チタンプレート１０の直径２ｍｍの前記取付孔１１は大きいため、前記旧チタンプレート１０が動き易く、また、前記取付孔１１が甲状軟骨１３の開窓線に近いため、前記旧チタンプレート１０を固定時に前記ナイロン糸で甲状軟骨が切断されてしまう症例が数例存在する。However, since the old titanium plate 10 is used for the purpose of pushing the thyroid cartilage piece 13 incised into a window shape, there is a problem that the thyroid cartilage piece incised after the operation tends to be thinned and the glottic gap tends to be widened. .
Further, the old titanium plate 10 is provided with a mounting hole 11 having a diameter of 2 mm in the center of the fixing portion, and is fixed to the thyroid cartilage 13 through the nylon thread in the mounting hole 11. The old titanium plate 10 is easy to move because the mounting hole 11 with a diameter of 2 mm of the old titanium plate 10 is larger than the nylon thread of 2-0 size (thickness of about 0.2 mm) used for this fixing. Since the mounting hole 11 is close to the fenestration line of the thyroid cartilage 13, there are several cases where the thyroid cartilage is cut with the nylon thread when the old titanium plate 10 is fixed.
したがって、生体親和性、長期安定性、及び易工作性に優れ、高度な手術手技に頼ることなく汎用性のある手術手技によって声帯を平行に押し込むことができ、１回の手術で治療効果を長期間に亘って維持することができる発声障害治療具の提供が望まれている。 Therefore, it has excellent biocompatibility, long-term stability, and easy workability, and it can push the vocal cords in parallel by a versatile surgical technique without relying on advanced surgical techniques. It is desired to provide a speech disorder treatment device that can be maintained over a period of time.
本発明は、従来における前記諸問題を解決し、以下の目的を達成することを課題とする。即ち、本発明は、生体親和性、長期安定性、及び易工作性に優れ、高度な手術手技に頼ることなく汎用性のある手術手技によって声帯を平行に押し込むことができ、１回の手術で治療効果を長期間に亘って維持することができる発声障害治療具を提供することを目的とする。 An object of the present invention is to solve the above-described problems and achieve the following objects. In other words, the present invention is excellent in biocompatibility, long-term stability, and easy workability, and can press the vocal cords in parallel by a versatile surgical technique without relying on advanced surgical techniques. An object of the present invention is to provide a speech disorder treatment device that can maintain a therapeutic effect over a long period of time.
前記課題を解決するための手段としての本発明の発声障害治療具は、第１の形態では、甲状軟骨を窓状に切開し、切開した甲状軟骨片を介さずに患側声帯を内方に移動させて声門閉鎖不全を治療するのに用いられる発声障害治療具であって、
チタン製の板状体であり、
一端に前記甲状軟骨に固定するための固定部と、
少なくとも２箇所に描かれた折曲線に沿って折曲可能な本体部と、を有することを特徴とする。
また、本発明の発声障害治療具は、第２の形態では、甲状軟骨を窓状に切開し、切開した甲状軟骨片を介さずに患側声帯を内方に移動させて声門閉鎖不全を治療するのに用いられる発声障害治療具であって、
チタン製の板状体であり、
一端に前記甲状軟骨に固定するための固定部と、
他端に前記甲状軟骨と当接する当接部と、
前記固定部と前記当接部の間に、前記固定部側から順に第１の折曲線及び第２の折曲線が描かれ、かつ前記第１の折曲線及び前記第２の折曲線に沿って折曲可能な本体部と、を有してなり、
前記固定部と前記本体部との間に描かれた第１の境界線に沿って谷折りし、前記第１の折曲線に沿って山折りし、前記第２の折曲線に沿って山折りし、前記本体部と前記当接部との間に描かれた第２の境界線に沿って谷折りしてなることを特徴とする。In the first embodiment, the dysphonia treatment device of the present invention as means for solving the above-mentioned problems is a thyroid cartilage incised in a window shape, and the affected vocal cord is moved inward without passing through the incised thyroid cartilage fragment. A dysphonia treatment tool used to treat glottic insufficiency,
It is a plate-shaped body made of titanium,
A fixing part for fixing to the thyroid cartilage at one end;
And a main body that can be bent along folding lines drawn in at least two places.
In the second embodiment, the vocal dysfunction treatment device of the present invention treats glottic insufficiency by incising the thyroid cartilage into a window shape and moving the affected vocal cord inward without passing through the incised thyroid cartilage fragment. A speech disorder treatment device used for
It is a plate-shaped body made of titanium,
A fixing part for fixing to the thyroid cartilage at one end;
An abutting part that abuts the thyroid cartilage at the other end;
A first fold line and a second fold line are drawn in order from the fixed part side between the fixed part and the contact part, and along the first fold line and the second fold line. A bendable main body, and
Fold along the first boundary line drawn between the fixed portion and the main body, fold along the first fold, and fold along the second fold In addition, a valley fold is formed along a second boundary line drawn between the main body portion and the contact portion.
本発明によれば、従来における前記諸問題を解決し、前記目的を達成することができ、生体親和性、長期安定性、及び易工作性に優れ、高度な手術手技に頼ることなく汎用性のある手術手技によって声帯を平行に押し込むことができ、１回の手術で治療効果を長期間に亘って維持することができる発声障害治療具を提供することができる。 According to the present invention, it is possible to solve the conventional problems and achieve the object, and is excellent in biocompatibility, long-term stability, and easy workability, and versatile without depending on advanced surgical techniques. The vocal cords can be pushed in parallel by a certain surgical technique, and a vocal dysfunction treatment device that can maintain the therapeutic effect for a long period of time by one operation can be provided.
（発声障害治療具）
本発明の発声障害治療具は、第１の形態では、チタン製の板状体であり、固定部と、本体部とを有し、当接部を有することが好ましく、更に必要に応じてその他の部を有してなる。
本発明の発声障害治療具は、第２の形態では、チタン製の板状体であり、固定部と、当接部と、本体部とを有し、押込部を有することが好ましく、更に必要に応じてその他の部を有してなる。前記第２の形態の発声障害治療具は、折曲加工した後の発声障害治療具である。
前記第１及び第２の形態の発声障害治療具は、甲状軟骨を窓状に切開し、切開した甲状軟骨片を介さずに（直接）患側声帯を内方に移動させて声門閉鎖不全を治療するのに用いられる。(Speech disorder treatment device)
In the first embodiment, the speech disorder treatment device of the present invention is a plate-like body made of titanium, preferably has a fixing portion and a main body portion, and preferably has an abutting portion. It has a part.
In the second embodiment, the speech disorder treatment device of the present invention is a plate-like body made of titanium, and preferably has a fixing portion, a contact portion, and a main body portion, and preferably has a pushing portion. Depending on the situation, it has other parts. The vocal dysfunction treatment device of the second form is a dysphonic treatment device after bending.
The vocal dysfunction treatment device of the first and second embodiments treats glottal insufficiency by incising the thyroid cartilage into a window and moving the affected side vocal cords inwardly without passing through the incised thyroid cartilage fragment. Used to do.
＜チタン製の板状体＞
前記チタンとしては、純チタンが好適に用いられる。前記純チタンは、その化学成分と機械的性質により、日本ではＪＩＳ Ｈ４６００ １種〜４種に、米国ではＡＳＴＭＦ６７．Ｇｒａｄｅ１〜Ｇｒａｄｅ４の４種に分類されている。これらの中でも、加工性と強度のバランスが良く医療用器具として最も多く使用されている点から、ＡＳＴＭＦ６７．Ｇｒａｄｅ２（ＪＩＳ Ｈ４６００ ２種に相当）の純チタンが好ましい。
本発明の発声障害治療具は、前記適正な材質、所定の厚み、及び適度な強度を有する板状体（プレート）であるため、患者の状態に合わせて所望の形状に折曲たり、変形させることにより、前記フリードリッヒのインプラントでは困難であった「前方（前交連）の押込量」及び「押込幅」の調節が可能である。<Titanium plate>
Pure titanium is preferably used as the titanium. The pure titanium is classified into JIS H4600 1 to 4 in Japan and ASTM F67. It is classified into four types of Grade1 to Grade4. Among these, ASTMF67. Has a good balance between workability and strength and is most frequently used as a medical instrument. Grade 2 (equivalent to JIS H4600 type 2) pure titanium is preferred.
Since the speech disorder treatment device of the present invention is a plate-like body (plate) having the appropriate material, a predetermined thickness, and appropriate strength, it is bent or deformed to a desired shape according to the patient's condition. Thus, it is possible to adjust the “forward (front commissure) push amount” and “push width”, which is difficult with the Friedrich implant.
＜固定部＞
前記固定部は、前記発声障害治療具の一端において、甲状軟骨に固定するための部である。
前記固定部は、前記発声障害治療具を甲状軟骨に固定可能であれば材質、大きさ、形状、構造等については、特に制限はなく、目的に応じて適宜選択することができる。前記材質としては、純チタンが用いられる。
前記固定部の形状、大きさ等についても、特に制限はなく、目的に応じて適宜選択することができ、通常用いられる程度の形状及び大きさが好ましい。前記固定部の構造としては、単層構造であることが好ましい。<Fixed part>
The fixing portion is a portion for fixing to the thyroid cartilage at one end of the speech disorder treatment device.
As long as the dysphonia treatment device can be fixed to the thyroid cartilage, the fixing portion is not particularly limited as to the material, size, shape, structure, etc., and can be appropriately selected according to the purpose. Pure titanium is used as the material.
There is no restriction | limiting in particular also about the shape, magnitude | size, etc. of the said fixing | fixed part, According to the objective, it can select suitably, The shape and magnitude | size of the grade normally used are preferable. The structure of the fixing part is preferably a single layer structure.
前記固定部には、少なくとも２つの取付孔を有することが好ましく、２つの取付孔を有することがより好ましい。これにより、声帯との角度が平行な甲状軟骨の前方２箇所で固定を行うことができ、本発明の発声障害治療具であるチタンプレートのずれや傾きを防止できる。
前記２つの取付孔は、前記発声障害治療具の軸線と直交方向に設けることが好ましい。
前記取付孔を設ける位置は、前記発声障害治療具の先端及び上下端から、０．５ｍｍ内側であることが好ましい。これにより、甲状軟骨の開窓線から離れることで、固定時に軟骨が切断されることを防止できる。
前記取付孔の直径は、０．８ｍｍ〜１．２ｍｍが好ましく、１ｍｍがより好ましい。前記直径が、１．２ｍｍを超えると、前記取付孔が先端及び上下端から０．５ｍｍしか離れていないため、前記取付孔の直径を大きくし過ぎると、前記取付孔の辺縁が先端及び上下端に近づきすぎて、前記発声障害治療具における前記取付孔近傍の強度が低下してしまうことがある。The fixing portion preferably has at least two mounting holes, and more preferably has two mounting holes. Thereby, fixation can be performed at two front portions of the thyroid cartilage whose angle with the vocal cord is parallel, and displacement and inclination of the titanium plate that is the speech disorder treatment device of the present invention can be prevented.
The two mounting holes are preferably provided in a direction perpendicular to the axis of the speech disorder treatment device.
It is preferable that the position where the attachment hole is provided is 0.5 mm inside from the distal end and the upper and lower ends of the vocal dysfunction treatment tool. Thereby, it can prevent that a cartilage is cut | disconnected at the time of fixation by leaving | separating from the fenestration line of a thyroid cartilage.
The diameter of the mounting hole is preferably 0.8 mm to 1.2 mm, and more preferably 1 mm. If the diameter exceeds 1.2 mm, the mounting hole is only 0.5 mm away from the tip and upper and lower ends. Therefore, if the diameter of the mounting hole is made too large, the edge of the mounting hole will be It may be too close to the end, and the strength in the vicinity of the mounting hole in the dysphonia treatment device may decrease.
＜本体部＞
前記本体部は、少なくとも２箇所に描かれた折曲線に沿って折曲可能な部である。
前記本体部は、前記折曲線に沿って折曲可能であれば材質、大きさ、形状、構造等については、特に制限はなく、目的に応じて適宜選択することができる。前記材質としては、純チタンが用いられる。
前記本体部の形状、大きさ等についても、特に制限はなく、目的に応じて適宜選択することができ、通常用いられる程度の形状及び大きさが好ましい。前記本体部の構造としては、単層構造であることが好ましい。
前記本体部は、前記固定部と一体であることが好ましい。<Main body>
The main body portion is a portion that can be bent along folding lines drawn in at least two places.
As long as the main body can be bent along the folding line, the material, size, shape, structure and the like are not particularly limited, and can be appropriately selected according to the purpose. Pure titanium is used as the material.
There is no restriction | limiting in particular also about the shape of the said main-body part, a magnitude | size, etc., It can select suitably according to the objective, The shape and magnitude | size of the grade normally used are preferable. The structure of the main body is preferably a single layer structure.
It is preferable that the main body portion is integral with the fixing portion.
前記少なくとも２箇所に描かれた折曲線としては、第１の折曲線及び第２の折曲線であることが好ましい。
前記第１の折曲線及び前記第２の折曲線としては、前記固定部側から順に第１の折曲線及び第２の折曲線が描かれていることが好ましい。
前記第１の折曲線と前記第２の折曲線との間の距離を調整することにより、前記第１の折曲線及び前記第２の折曲線を折曲加工して形成される押込部の長さを調整することができる。
前記折曲線は、特に制限はなく、目的に応じて適宜選択することができるが、例えば、レーザーマーキングにより描かれることが好ましい。
前記第１の折曲線及び前記第２の折曲線のそれぞれと、発声障害治療具の軸線とがなす劣角は、いずれも７０度〜８０度（優角１００度〜１１０度）であり、７５度（優角１０５度）が好ましい。これにより、前記旧チタンプレート（９０度）に比べて１０度〜２０度の傾きを持たせることができ、声帯と平行に本発明の発声障害治療具であるチタンプレートを押し込むことができる。The folding lines drawn in at least two places are preferably a first folding line and a second folding line.
As the first fold curve and the second fold curve, it is preferable that a first fold curve and a second fold curve are drawn in order from the fixed portion side.
The length of the pushing portion formed by bending the first fold curve and the second fold curve by adjusting the distance between the first fold curve and the second fold curve. Can be adjusted.
The folding curve is not particularly limited and may be appropriately selected depending on the intended purpose. For example, it is preferably drawn by laser marking.
The minor angles formed by each of the first fold curve and the second fold curve and the axis of the dysphonia treatment tool are both 70 degrees to 80 degrees (dominant angle 100 degrees to 110 degrees), 75 Degree (major angle 105 degrees) is preferable. Thereby, compared with the said old titanium plate (90 degree | times), it can have 10 to 20 degree | times inclination, and the titanium plate which is a speech disorder treatment tool of this invention can be pushed in parallel with a vocal cord.
前記第１の折曲線の数については、特に制限はなく、目的に応じて適宜選択することができるが、所定間隔離間して３つ描かれていることが好ましい。この場合、隣接する第１の折曲線同士の間隔は１ｍｍが好ましい。
前記第２の折曲線の数については、特に制限はなく、目的に応じて適宜選択することができるが、所定間隔離間して３つ描かれていることが好ましい。この場合、隣接する第２の折曲線同士の間隔は１ｍｍが好ましい。There is no restriction | limiting in particular about the number of said 1st folding lines, Although it can select suitably according to the objective, It is preferable that three are drawn at predetermined intervals. In this case, the interval between adjacent first folding lines is preferably 1 mm.
There is no restriction | limiting in particular about the number of said 2nd folding lines, Although it can select suitably according to the objective, It is preferable that three are drawn at predetermined intervals. In this case, the interval between the adjacent second folding lines is preferably 1 mm.
前記発声障害治療具を折曲加工する際には、前記３つの第１の折曲線の中から１つの第１の折曲線を選択して該第１の折曲線に沿って山折すると共に、前記３つの第２の折曲線の中から１つの第２の折曲線を選択して該第２の折曲線に沿って山折することで押込部を形成することができる。これにより、患者の声帯膜様部の長さ、及び声帯麻痺による声帯の弓状変化の程度に合わせて前記押込部の長さを調節することができる。
前記押込部の長さは、特に制限はなく、目的に応じて適宜選択することができるが、８ｍｍ〜１４ｍｍが好ましい。前記押込部の長さが、８ｍｍ未満であると、発声障害の治療効果が得られないことがあり、１４ｍｍを超えると、声帯を押し過ぎてしまい詰まった音声となることがある。
なお、前記発声障害治療具の折曲加工は、特に制限はなく、目的に応じて適宜選択することができ、例えば、鉗子などを用いて行うことができる。When bending the vocal dysfunction treatment tool, one first fold line is selected from the three first fold lines, and a mountain fold is made along the first fold line. The pushing portion can be formed by selecting one second folding curve from the three second folding curves and folding the mountain along the second folding curve. Thereby, the length of the pushing portion can be adjusted in accordance with the length of the vocal cord membrane-like portion of the patient and the degree of arcuate change of the vocal cord due to vocal cord paralysis.
There is no restriction | limiting in particular in the length of the said pushing part, Although it can select suitably according to the objective, 8 mm-14 mm are preferable. If the length of the push-in portion is less than 8 mm, there may be a case where the treatment effect for dysphonia cannot be obtained. If the length exceeds 14 mm, the vocal cords may be pushed too much, resulting in a clogged sound.
In addition, the bending process of the speech disorder treatment device is not particularly limited, and can be appropriately selected according to the purpose. For example, it can be performed using forceps or the like.
＜当接部＞
前記当接部は、前記発声障害治療具の他端において、甲状軟骨と当接する部である。
前記当接部は、甲状軟骨と当接可能であれば材質、大きさ、形状、構造等については、特に制限はなく、目的に応じて適宜選択することができる。前記材質としては、純チタンが用いられる。
前記当接部の形状、大きさ等についても、特に制限はなく、目的に応じて適宜選択することができ、通常用いられる程度の形状及び大きさが好ましい。前記当接部の構造としては、単層構造であることが好ましい。
前記当接部は、前記本体部と一体であることが好ましい。
前記当接部の大きさ（長さ）は、特に制限はなく、目的に応じて適宜選択することができるが、２ｍｍ〜５ｍｍが好ましい。
前記当接部は、前記発声障害治療具を甲状軟骨に取り付けた際には、通常、甲状軟骨の内側から当接する。<Contact part>
The contact portion is a portion that contacts the thyroid cartilage at the other end of the vocal dysfunction treatment tool.
The material, size, shape, structure, and the like of the abutting portion are not particularly limited as long as they can abut on thyroid cartilage, and can be appropriately selected according to the purpose. Pure titanium is used as the material.
There is no restriction | limiting in particular also about the shape of the said contact part, a magnitude | size, etc., It can select suitably according to the objective, The shape and magnitude | size of the grade normally used are preferable. The structure of the contact portion is preferably a single layer structure.
The contact portion is preferably integral with the main body portion.
The size (length) of the contact portion is not particularly limited and may be appropriately selected depending on the purpose, but is preferably 2 mm to 5 mm.
The abutment portion normally abuts from the inside of the thyroid cartilage when the speech disorder treatment device is attached to the thyroid cartilage.
本発明の発声障害治療具としてのチタンプレートは、例えば、福井県鯖江市の株式会社若吉製作所［２００５年３月、ＱＭＳ（国際規格ＩＳＯ１３４８５に準ずる）高度管理医療機器クラス・製造販売承認・許可を取得］により製造されたものを用いることができる。
前記発声障害治療具の平均厚みは、０．１５ｍｍ以上０．２５ｍｍ未満が好ましく、０．２ｍｍがより好ましい。前記平均厚みが、０．１５ｍｍ未満であると、強度が担保できず折り曲げ加工時に折れてしまうことがあり、０．２５ｍｍ以上であると、硬くなりすぎ、折曲加工が容易に行えないことがある。
前記平均厚みの範囲であると、手術中にニッパーで切断することにより前記発声障害治療具の長さの調節を容易に行うことができる。Titanium plate as a speech disorder treatment device of the present invention is, for example, Wakayoshi Manufacturing Co., Ltd., Sabae City, Fukui Prefecture (March 2005, QMS (according to international standard ISO 13485) highly-managed medical device class / manufacturing approval / permission Can be used.
The average thickness of the speech disorder treatment device is preferably 0.15 mm or more and less than 0.25 mm, and more preferably 0.2 mm. If the average thickness is less than 0.15 mm, the strength cannot be ensured and may be broken during the bending process. If the average thickness is 0.25 mm or more, it is too hard and the bending process cannot be performed easily. is there.
When the average thickness is within the range, it is possible to easily adjust the length of the speech disorder treatment tool by cutting with a nipper during surgery.
前記発声障害治療具の長さは、２５ｍｍ〜３０ｍｍが好ましく、２８ｍｍがより好ましい。これにより、前記旧チタンプレートの長さ（２０ｍｍ）よりも長いので、甲状軟骨を窓状に切開し、切開した甲状軟骨片を介さないで（直接）患側声帯を内方に移動させて声門閉鎖不全を治療する方式に適用することができる。
本発明の発声障害治療具は、前記発声障害治療具の長さの範囲とすることにより、喉頭の大きさが異なる男性と女性であっても、１種類の長さのチタンプレートで兼用することができる。The length of the speech disorder treatment tool is preferably 25 mm to 30 mm, more preferably 28 mm. As a result, the length of the old titanium plate (20 mm) is longer, so the thyroid cartilage is incised into a window, and the affected vocal cords are moved inward without passing through the incised thyroid cartilage fragment to close the glottis. It can be applied to a method of treating failure.
The vocal dysfunction treatment device of the present invention can be combined with a single length of titanium plate even for men and women with different laryngeal sizes by making the length range of the dysphonia treatment device. Can do.
ここで、図９Ａは、本発明の発声障害治療具であるチタンプレートの写真、図９Ｂは、本発明の発声障害治療具であるチタンプレートの平面図、図９Ｃは、図９Ｂの本体部の部分拡大図である。
前記発声障害治療具２０は、チタン製の板状体であり、一端に前記甲状軟骨に固定するための固定部２１と、他端に前記甲状軟骨と当接する当接部２３と、前記固定部２１と前記当接部２３の間に、前記固定部２１側から順に第１の折曲線２４及び第２の折曲線２５が描かれ、かつ前記第１の折曲線２４及び前記第２の折曲線２５に沿って折曲可能な本体部２２と、を有している。Here, FIG. 9A is a photograph of a titanium plate that is a speech disorder treatment device of the present invention, FIG. 9B is a plan view of a titanium plate that is a speech disorder treatment device of the present invention, and FIG. 9C is a view of the main body of FIG. It is a partial enlarged view.
The vocal dysfunction treatment device 20 is a plate-shaped body made of titanium, and has a fixing portion 21 for fixing to the thyroid cartilage at one end, a contact portion 23 that contacts the thyroid cartilage at the other end, and the fixing portion. The first fold line 24 and the second fold line 25 are drawn in this order from the fixed part 21 side between the first fold line 24 and the second fold line. 25, and a main body 22 that can be bent along the line 25.
本発明の発声障害治療具２０は、使用時（手術時）には、図９Ｂに示すチタンプレート２０を、第１の折曲線２４、第２の折曲線２５、第１の境界線２７、及び第２の境界線２８で折曲して、図１０に示す形状に折曲加工したものを用いる。
前記折曲加工としては、前記固定部２１と前記本体部２２との間に描かれた第１の境界線２７に沿って谷折りし、前記第１の折曲線２４に沿って山折りし、前記第２の折曲線２５に沿って山折りし、前記本体部２２と前記当接部２３との間に描かれた第２の境界線２８に沿って谷折りする。その結果、図１０に示す押込部３０が形成される。
前記第１の境界線２７及び前記第１の折曲線２４は、予め折曲加工されていることが、手術を円滑に進める点から好ましい。この場合、予め前記第１の境界線２７及び前記第１の折曲線２４で折り曲げられた形状のチタンプレートを数種類用意しておき、これらの中から、患者の状態に合わせて使用するチタンプレートを選択する。
次いで、選択されたチタンプレートを用い、患者の状態に合わせて３つの第２の折曲線の中から１つの前記第２の折曲線を選択して該第２の折曲線に沿って山折し、前記本体部と前記当接部との間に描かれた前記第２の境界線に沿って谷折りする。
図９Ｃに示すように、第１の折曲線２４及び第２の折曲線２５のそれぞれと、発声障害治療具の軸線２９とがなす劣角θ１、θ２は、いずれも７０度〜８０度であることが好ましい。これにより、前記旧チタンプレート（９０度）に比べて１０度〜２０度の傾きを持たせることができ、声帯と平行にチタンプレートを押し込むことができる。In use (surgical operation), the speech disorder treatment device 20 of the present invention is obtained by attaching the titanium plate 20 shown in FIG. 9B to the first folding line 24, the second folding line 25, the first boundary line 27, and A material that is bent at the second boundary line 28 and bent into the shape shown in FIG. 10 is used.
As the bending process, a valley fold is performed along the first boundary line 27 drawn between the fixed portion 21 and the main body portion 22, and a mountain fold is performed along the first folding curve 24. A mountain fold is performed along the second fold line 25 and a valley fold is performed along a second boundary line 28 drawn between the main body portion 22 and the contact portion 23. As a result, the pushing portion 30 shown in FIG. 10 is formed.
The first boundary line 27 and the first folding line 24 are preferably bent in advance from the viewpoint of smoothly proceeding with surgery. In this case, several types of titanium plates that are bent in advance at the first boundary line 27 and the first folding line 24 are prepared in advance, and a titanium plate to be used according to the patient's condition is selected from these. select.
Next, using the selected titanium plate, one of the second folding curves is selected from among the three second folding curves according to the patient's condition, and the mountain folding is performed along the second folding curves. Folding is performed along the second boundary line drawn between the main body portion and the contact portion.
As shown in FIG. 9C, the minor angles θ1 and θ2 formed by each of the first folding line 24 and the second folding line 25 and the axis 29 of the speech disorder treatment tool are both 70 degrees to 80 degrees. It is preferable. Thereby, compared with the said old titanium plate (90 degree | times), it can give 10 to 20 degree | times inclination, and can push a titanium plate in parallel with a vocal cord.
本発明の発声障害治療具は、使用時に、患者の状態などに応じて、折曲加工して用いられる。
前記旧チタンプレートは、図７に示すように、予め、クランク状（９０度）に折曲加工されているため、甲状軟骨の形状と開窓部及び咽頭の内部構造の影響から、挿入時にチタンプレート先端が上方（頭側）へ向いている。ただし、前記旧チタンプレートのように甲状軟骨片を押し込む方式であれば、チタンプレートの傾きは特に問題にならない。
これに対して、本発明の発声障害治療具であるチタンプレートは、切開した甲状軟骨片を介さないで直接押し込む方式を採用しているため、チタンプレートを声帯に平行に押し込まないと音声に影響が生じ、治療効果が得られない。そのため、予め、図９Ｃに示すように、第１の折曲線２４及び第２の折曲線２５のそれぞれと、前記発声障害治療具２０の軸線２９とのなす劣角θ１、θ２が、いずれも７０度〜８０度となること、即ち、前記旧チタンプレート（９０度）に比べて１０度〜２０度の傾きを設けておくことにより、チタンプレートを挿入時に生じる上方（頭側）への傾きを相殺できるので、声帯と平行にチタンプレートを押し込むことができる。The vocal dysfunction treatment device of the present invention is used after being bent according to the patient's condition and the like when used.
Since the old titanium plate is bent into a crank shape (90 degrees) in advance as shown in FIG. 7, the titanium plate is inserted at the time of insertion due to the shape of the thyroid cartilage and the internal structure of the fenestration and pharynx. The plate tip is facing upward (head side). However, if the thyroid cartilage piece is pushed in like the old titanium plate, the tilt of the titanium plate is not particularly problematic.
On the other hand, the titanium plate that is a speech disorder treatment device according to the present invention employs a method in which the titanium plate is directly pushed without passing through an incised piece of thyroid cartilage. Occurs, and the therapeutic effect cannot be obtained. Therefore, as shown in FIG. 9C, the minor angles θ1 and θ2 formed by the first fold line 24 and the second fold line 25 and the axis 29 of the utterance disorder treatment device 20 are both 70 in advance. The tilt is 10 degrees to 20 degrees compared to the old titanium plate (90 degrees), so that the upward tilt (head side) that occurs when the titanium plate is inserted can be reduced. Since it can cancel, the titanium plate can be pushed in parallel to the vocal cords.
更に、本発明の発声障害治療具であるチタンプレートに傾きを持たせることの必要性及び有効性について説明する。
図１３Ａ及び図１３Ｂに示すように、甲状軟骨１３から剥離した内軟骨膜３２及び喉頭内部の構造（例えば、声帯１４）が、甲状軟骨１３と平行の状態にあれば前記旧チタンプレート１０に傾きを設ける必要はない。しかし、内軟骨膜３２をはじめとした喉頭の内部構造の多くは甲状軟骨１３内に存在しているため、手術の際に、前記旧チタンプレート１０で声帯１４を内方へ押し込むと甲状軟骨１３から剥離した内軟骨膜３２及び咽頭内部の構造は弓状に湾曲してしまう（図１４Ａ及び図１４Ｂ参照）。その結果、図１４Ａ、図１４Ｂ及び図１５に示すように、甲状軟骨１３の開窓部３１は腹尾側に設けられるため、開窓部３１に挿入した前記旧チタンプレート１０の先端は甲状軟骨の頭尾側及び腹背側の中心の内側方向、即ち、上方（頭側）へ傾いてしまう。声帯１４の内方移動を行うにあたり、内側の甲状軟骨１３を長方形の板状体としてみると甲状軟骨形成術Ｉ型の開窓部３１の位置は前下方に位置する（図１３Ａ及び図１４Ａ）。剥離した内軟骨膜の周囲は甲状軟骨１３に付着しているため（図１４Ｂ破線部分）、内軟骨膜と甲状軟骨１３との距離は下方では短く上方にいくにつれて長くなり、片側甲状軟骨板の中央部分が最も長く（深く）なる。 甲状軟骨形成術Ｉ型の開窓部３１の位置は甲状軟骨下端に近いため内軟骨膜は甲状軟骨付着による可動制限を受ける（図１４Ａ及び図１４Ｂ）。このため、長軸面に対して９０°に折り曲げた旧チタンプレート１０を用いると、内方移動した際にこの制限を受け旧チタンプレート１０の先端が上方（甲状軟骨板の中央方向）へ向き、声帯１４と平行に押し込むことができない。
そこで、チタンプレートを挿入時の上方（頭側）への傾きと相殺させて、声帯と平行に前記チタンプレートを押し込むことができるように、本発明の発声障害治療具であるチタンプレート２０を使用時には、患者の状態に合わせて、図９Ｃに示すように、第１の折曲線２４及び第２の折曲線２５のそれぞれと、前記発声障害治療具２０の軸線２９とのなす劣角θ１、θ２が、いずれも７０度〜８０度となるように折曲加工を行うこと、即ち、図７に示す前記旧チタンプレート１０（９０度）に比べて１０度〜２０度の傾きを設けておくことが必要となる。
このことは、図１６〜図２０に示すように、５名の患者（６２歳男性、６６歳男性、６６歳男性、７２歳男性、８４歳男性）について、実際に、本発明の発声障害治療具であるチタンプレートを取り付ける手術を行った後の頸部ＣＴの冠状断画像の結果及び図２１Ａ、図２１Ｂの結果から、５名の患者全員について、チタンプレートが声帯と平行に留置されていることから明らかである。Furthermore, the necessity and effectiveness of giving a tilt to the titanium plate that is the speech disorder treatment device of the present invention will be described.
As shown in FIGS. 13A and 13B, if the endochondral membrane 32 peeled off from the thyroid cartilage 13 and the structure inside the larynx (for example, the vocal cord 14) are parallel to the thyroid cartilage 13, the old titanium plate 10 is inclined. There is no need to provide. However, since most of the internal structure of the larynx including the endochondral membrane 32 is present in the thyroid cartilage 13, when the vocal cord 14 is pushed inward by the old titanium plate 10 during the operation, the thyroid cartilage 13 The endochondral membrane 32 peeled off and the structure inside the pharynx are curved in an arcuate shape (see FIGS. 14A and 14B). As a result, as shown in FIG. 14A, FIG. 14B and FIG. 15, since the fenestration part 31 of the thyroid cartilage 13 is provided on the abdominal tail side, the tip of the old titanium plate 10 inserted into the fenestration part 31 is thyroid cartilage. Of the center of the head and tail side and the back of the stomach, that is, upward (head side). In performing the inward movement of the vocal cord 14, when the inner thyroid cartilage 13 is viewed as a rectangular plate-like body, the position of the thyroid chondroplasty type I fenestration part 31 is located at the front and lower side (FIGS. 13A and 14A). . Since the periphery of the peeled endochondral membrane is attached to the thyroid cartilage 13 (the broken line portion in FIG. 14B), the distance between the endochondral membrane and the thyroid cartilage 13 is short in the downward direction and becomes longer as it goes upward. The center part is the longest (deep). Since the position of the fenestration 31 of the thyroid cartilage surgery type I is close to the lower end of the thyroid cartilage, the endochondral membrane is restricted by the movement of the thyroid cartilage (FIGS. 14A and 14B). For this reason, if the old titanium plate 10 bent at 90 ° with respect to the long axis surface is used, the tip of the old titanium plate 10 is directed upward (in the central direction of the thyroid cartilage plate) due to this restriction when moved inward. It cannot be pushed in parallel with the vocal cords 14.
Therefore, the titanium plate 20 which is a treatment device for dysphonia according to the present invention is used so that the titanium plate can be pushed in parallel to the vocal cords by offsetting the tilt (upward side) when the titanium plate is inserted. Sometimes, depending on the patient's condition, as shown in FIG. 9C, the subordinate angles θ1, θ2 formed by the first folding line 24 and the second folding line 25 and the axis 29 of the speech disorder treatment device 20, respectively. However, the bending process should be performed so that both are 70 degrees to 80 degrees, that is, an inclination of 10 degrees to 20 degrees is provided as compared with the old titanium plate 10 (90 degrees) shown in FIG. Is required.
As shown in FIG. 16 to FIG. 20, this is actually the case of five patients (62 year old male, 66 year old male, 66 year old male, 72 year old male, 84 year old male). From the results of coronal section images of the cervical CT after performing the operation of attaching the titanium plate, which is a tool, and the results of FIGS. 21A and 21B, the titanium plates are placed in parallel with the vocal cords for all five patients. It is clear from this.
本発明の発声障害治療具であるチタンプレートの使用方法としては、特に制限はなく、目的に応じて適宜選択することができるが、図１１及び図１２に示すように、患側甲状軟骨を露出し、一色の原法（甲状軟骨形成術Ｉ型）に従い軟骨を窓状に切開し、患者の状態に合わせて所望の位置で第２の折曲線２５及び第２の境界線２８を折曲げてチタンプレート２０を折曲加工する。その後、折曲加工したチタンプレートを実際に用いて声の状態を確認し微調整を行う。次に、折曲加工したチタンプレートの固定部２１の２つの取付孔２６，２６にナイロン糸を通して、チタンプレートの固定部２１を甲状軟骨に固定する。次に、押込部３０が患側声帯を内方に押込んだ状態となる位置に調整し、チタンプレートの当接部２３を内側から甲状軟骨に当接させて、チタンプレート２０を留置することができる。 The method for using the titanium plate, which is a speech disorder treatment device of the present invention, is not particularly limited and can be appropriately selected according to the purpose. However, as shown in FIGS. 11 and 12, the affected thyroid cartilage is exposed. The cartilage is incised in a window shape according to the original method (Thyrochondroplasty Type I), and the second folding line 25 and the second boundary line 28 are bent at a desired position according to the patient's condition, thereby forming titanium. The plate 20 is bent. After that, the state of the voice is confirmed and finely adjusted by actually using the bent titanium plate. Next, the fixing portion 21 of the titanium plate is fixed to the thyroid cartilage through nylon threads through the two attachment holes 26 and 26 of the fixing portion 21 of the titanium plate that has been bent. Next, the pushing portion 30 is adjusted to a position where the affected vocal cord is pushed inward, and the titanium plate abutment portion 23 is brought into contact with the thyroid cartilage from the inside to place the titanium plate 20 in place. it can.
本発明の発声障害治療具は、生体親和性、長期安定性、及び易工作性に優れ、高度な手術手技に頼ることなく汎用性のある手術手技によって声帯を平行に押し込むことができ、１回の手術で治療効果を長期間に亘って維持することができるので、発声障害の治療に極めて有効である。 The vocal dysfunction treatment device of the present invention is excellent in biocompatibility, long-term stability, and easy workability, and can push the vocal cords in parallel by a versatile surgical technique without relying on advanced surgical techniques. Since the therapeutic effect can be maintained over a long period of time by this surgery, it is extremely effective in the treatment of speech disorders.
本発明の発声障害治療具の適応対象となる発声障害は、反回神経麻痺（声帯麻痺）、外傷、癌の手術、加齢等が原因となり、一側の声帯が正中位（閉塞位）への内転障害もしくは萎縮をきたし声門閉鎖不全を生じ、息漏れや嗄声（気息性嗄声）による音声障害、食物や唾液の気管への垂れ込みによる嚥下障害などを生じた患者に対して声門閉鎖不全を改善する目的で使用することができる。 The vocal dysfunction to which the vocal dysfunction treatment device of the present invention is applied is caused by recurrent nerve palsy (voice vocal cord paralysis), trauma, cancer surgery, aging, etc., and one side of the vocal fold becomes median (obstructed) Dystrophy or atrophy resulting in glottal insufficiency, dysphonia due to breath leak or hoarseness (breathing hoarseness), dysphagia due to sagging food or saliva into the trachea, etc. Can be used for the purpose of improving.
以下、本発明の実施例を説明するが、本発明は、これらの実施例に何ら限定されるものではない。 Examples of the present invention will be described below, but the present invention is not limited to these examples.
（実施例１）
発声障害治療具として、図９Ａ〜図９Ｃに示すチタンプレート［（福井県鯖江市の株式会社若吉製作所製、２００５年３月、ＱＭＳ（国際規格ＩＳＯ１３４８５に準ずる）高度管理医療機器クラス・製造販売承認・許可を取得）を用いた。
このチタンプレートは、ＡＳＴＭＦ６７．Ｇｒａｄｅ２（ＪＩＳ Ｈ４６００ ２種に相当）の純チタンを使用しており、長さ２８ｍｍ、最大幅５ｍｍ、厚み０．２ｍｍであり、固定部２１には発声障害治療具の軸線２９と直交方向に直径１．０ｍｍの取付孔２６を２つ設けている。
予め第１の境界線２７及び第１の折曲線２４が折り曲げられたチタンプレートを数種類用意しておき、これらの中から、患者の状態に合わせて使用するチタンプレートを選択する。Example 1
Titanium plate as shown in FIGS. 9A to 9C (manufactured by Wakayoshi Manufacturing Co., Ltd., Sabae City, Fukui Prefecture, March 2005, QMS (according to international standard ISO 13485)) Acquired approval / permission).
This titanium plate is ASTMF67. Grade 2 (equivalent to 2 types of JIS H4600) pure titanium is used, it has a length of 28 mm, a maximum width of 5 mm, and a thickness of 0.2 mm. The fixed portion 21 has a diameter perpendicular to the axis 29 of the speech disorder treatment device. Two 1.0 mm mounting holes 26 are provided.
Several types of titanium plates in which the first boundary line 27 and the first folding line 24 are bent in advance are prepared, and a titanium plate to be used is selected from these according to the patient's condition.
まず、声門閉鎖不全の患者（６２歳男性）に局所麻酔下で患側甲状軟骨翼を露出し、一色の原法（甲状軟骨形成術Ｉ型）に従い甲状軟骨を窓状に切開した。なお、切開した甲状軟骨片は取り出した。
次に、開窓部の周囲の内軟骨膜を軟骨から剥離し、直角に曲がった（Ｌ字状の）剥離子を用いて開窓部から声帯を押し込み、患者に発声してもらいながら最適な押込み幅と深さを検討してその状態に合わせて、所望の位置で第２の折曲線２５及び第２の境界線２８を折り曲げてチタンプレートを折曲加工した。その後、前記折曲加工したチタンプレートを実際に用いて患者の声の状態を確認しつつ微調整を行った。
次に、前記折曲加工したチタンプレートの固定部２１の２つの取付孔２６，２６にナイロン糸を通して、固定部２１を甲状軟骨に固定した。
次に、前記チタンプレートの押込部３０が患側声帯を内方に押込んだ状態となる位置に調整し、前記チタンプレートの当接部２３を内側から甲状軟骨に当接させて、前記チタンプレートを取り付けた。前記チタンプレートを取り付けた後の喉頭ＣＴ及びシェーマを図１６に、３次元正面図及び側面図を図２１Ａ及び図２１Ｂに示した。
図１６、図２１Ａ及び図２１Ｂの結果から、チタンプレートが声帯と平行に留置されていることがわかった。
手術後は、発声障害は改善され、正常発声に戻り、６ヶ月を過ぎても異常は認められず、発声にも変化が認められなかった。First, the affected thyroid cartilage wing was exposed to a glottal insufficiency patient (a 62-year-old male) under local anesthesia, and the thyroid cartilage was incised into a window according to the original method (thyroid chondroplasty type I). Incised thyroid cartilage pieces were removed.
Next, the inner perichondrium around the fenestration is peeled off from the cartilage, and the vocal cords are pushed in from the fenestration using an exfoliant bent at right angles (L-shaped), and the patient is uttered and optimized. The indentation width and depth were examined and the titanium plate was bent by bending the second folding line 25 and the second boundary line 28 at desired positions according to the state. Thereafter, fine adjustment was performed while actually confirming the state of the patient's voice using the bent titanium plate.
Next, the fixing portion 21 was fixed to the thyroid cartilage by passing nylon thread through the two mounting holes 26 and 26 of the fixing portion 21 of the titanium plate that was bent.
Next, the titanium plate push-in portion 30 is adjusted to a position where the affected vocal cord is pushed inward, and the titanium plate abutment portion 23 is brought into contact with the thyroid cartilage from the inside, so that the titanium plate Attached. The larynx CT and schema after attaching the titanium plate are shown in FIG. 16, and the three-dimensional front view and side view are shown in FIGS. 21A and 21B.
From the results of FIG. 16, FIG. 21A and FIG. 21B, it was found that the titanium plate was placed parallel to the vocal cords.
After the operation, the dysphonia was improved, returned to normal utterance, no abnormality was observed after 6 months, and no change was observed in utterance.
本発明の態様としては、例えば、以下のものなどが挙げられる。
＜１＞ 甲状軟骨を窓状に切開し、切開した甲状軟骨片を介さないで患側声帯を内方に移動させて声門閉鎖不全を治療するのに用いられる発声障害治療具であって、
チタン製の板状体であり、
一端に前記甲状軟骨に固定するための固定部と、
少なくとも２箇所に描かれた折曲線に沿って折曲可能な本体部と、を有することを特徴とする発声障害治療具である。
＜２＞ 少なくとも２箇所に描かれた折曲線が、第１の折曲線及び第２の折曲線であり、前記第１の折曲線及び前記第２の折曲線のそれぞれと、発声障害治療具の中心線とがなす劣角が、７０度〜８０度である前記＜１＞に記載の発声障害治療具である。
＜３＞ 固定部が、少なくとも２つの取付孔を有する前記＜１＞から＜２＞のいずれかに記載の発声障害治療具である。
＜４＞ 平均厚みが、０．１５ｍｍ以上０．２５ｍｍ未満である前記＜１＞から＜３＞のいずれかに記載の発声障害治療具である。
＜５＞ チタン製の板状体が、ＡＳＴＭＦ６７．Ｇｒａｄｅ２の純チタンからなる前記＜１＞から＜４＞のいずれかに記載の発声障害治療具である。
＜６＞ 甲状軟骨を窓状に切開し、切開した甲状軟骨片を介さずに患側声帯を内方に移動させて声門閉鎖不全を治療するのに用いられる発声障害治療具であって、
チタン製の板状体であり、
一端に前記甲状軟骨に固定するための固定部と、
他端に前記甲状軟骨と当接する当接部と、
前記固定部と前記当接部の間に、前記固定部側から順に第１の折曲線及び第２の折曲線が描かれ、かつ前記第１の折曲線及び前記第２の折曲線に沿って折曲可能な本体部と、を有してなり、
前記固定部と前記本体部との間に描かれた第１の境界線に沿って谷折りし、前記第１の折曲線に沿って山折りし、前記第２の折曲線に沿って山折りし、前記本体部と前記当接部との間に描かれた第２の境界線に沿って谷折りしてなることを特徴とする発声障害治療具である。
＜７＞ 第１の折曲線及び第２の折曲線のそれぞれと、発声障害治療具の中心線とがなす劣角が、７０度〜８０度である前記＜６＞に記載の発声障害治療具である。
＜８＞ 予め、第１の境界線に沿って谷折りされ、かつ第１の折曲線に沿って山折りされてなり、
第２の折曲線が、所定間隔離間して３つ描かれており、前記３つの第２の折曲線の中から１つの第２の折曲線を選択して該第２の折曲線に沿って山折することにより押込部を形成してなる前記＜６＞から＜７＞のいずれかに記載の発声障害治療具である。
＜９＞ 押込部の長さが、８ｍｍ〜１４ｍｍである前記＜８＞に記載の発声障害治療具である。Examples of the aspect of the present invention include the following.
<1> A dysphonia treatment tool used to treat glottic insufficiency by incising thyroid cartilage into a window and moving the affected vocal fold inward without passing through the incised thyroid cartilage piece,
It is a plate-shaped body made of titanium,
A fixing part for fixing to the thyroid cartilage at one end;
And a body part that can be bent along a folding line drawn in at least two places.
<2> The folding curves drawn in at least two places are the first folding curve and the second folding curve, and each of the first folding curve and the second folding curve, The dysphonia treatment device according to <1>, wherein an inferior angle formed by the center line is 70 degrees to 80 degrees.
<3> The dysphonia treatment device according to any one of <1> to <2>, wherein the fixing portion includes at least two attachment holes.
<4> The dysphonia treatment device according to any one of <1> to <3>, wherein the average thickness is 0.15 mm or more and less than 0.25 mm.
<5> A plate-shaped body made of titanium is ASTM F67. The dysphonia treatment device according to any one of <1> to <4>, which is made of pure titanium of Grade2.
<6> A vocal dysfunction treatment tool used to treat glottal insufficiency by incising thyroid cartilage into a window shape, moving the affected vocal fold inward without passing through the incised thyroid cartilage fragment,
It is a plate-shaped body made of titanium,
A fixing part for fixing to the thyroid cartilage at one end;
An abutting part that abuts the thyroid cartilage at the other end;
A first fold line and a second fold line are drawn in order from the fixed part side between the fixed part and the contact part, and along the first fold line and the second fold line. A bendable main body, and
Fold along the first boundary line drawn between the fixed portion and the main body, fold along the first fold, and fold along the second fold And it is a vocal dysfunction treatment tool characterized by being valley-folded along the 2nd boundary line drawn between the said main-body part and the said contact part.
<7> The vocal dysfunction treatment device according to <6>, wherein a minor angle formed by each of the first fold curve and the second fold curve and the center line of the speech dysfunction treatment device is 70 degrees to 80 degrees. It is.
<8> Preliminarily folded along the first boundary line and folded along the first folding line,
Three second folding curves are drawn at a predetermined interval, and one second folding curve is selected from the three second folding curves along the second folding curve. The dysphonia treatment device according to any one of <6> to <7>, wherein the pushing portion is formed by folding the mountain.
<9> The dysphonia treatment device according to <8>, wherein the pushing portion has a length of 8 mm to 14 mm.
本発明の発声障害治療具は、生体親和性、長期安定性、及び易工作性に優れ、高度な手術手技に頼ることなく汎用性のある手術手技によって声帯を平行に押し込むことができ、１回の手術で治療効果を長期間に亘って維持することができるので、反回神経麻痺（声帯麻痺）、外傷、癌の手術、加齢等が原因となり、一側の声帯が正中位（閉塞位）への内転障害もしくは萎縮をきたし声門閉鎖不全を生じ、息漏れや嗄声（気息性嗄声）による音声障害、食物や唾液の気管への垂れ込みによる嚥下障害などを生じた患者に対して声門閉鎖不全を改善する目的で使用することができる。 The vocal dysfunction treatment device of the present invention is excellent in biocompatibility, long-term stability, and easy workability, and can push the vocal cords in parallel by a versatile surgical technique without relying on advanced surgical techniques. Because the therapeutic effect can be maintained over a long period of time, the recurrent nerve palsy (voice vocal cord paralysis), trauma, cancer surgery, aging, etc., cause one side of the vocal cord to be in the middle position (obstructed position) ) Glottis for patients with adductive disorder or atrophy resulting in glottal insufficiency, voice impairment due to breath leak or hoarseness (breathing hoarseness), dysphagia due to sagging food or saliva into the trachea It can be used to improve regurgitation.
１ フリードリッヒのインプラント
１０ 旧チタンプレート
１１ 取付孔
１２ 甲状軟骨片
１３ 甲状軟骨
１４ 声帯
２０ 発声障害治療具
２１ 固定部
２２ 本体部
２３ 当接部
２４ 第１の折曲線
２５ 第２の折曲線
２６ 取付孔
２７ 第１の境界線
２８ 第２の境界線
２９ 軸線
３０ 押込部
３１ 開窓部
３２ 軟骨膜DESCRIPTION OF SYMBOLS 1 Friedrich's implant 10 Old titanium plate 11 Mounting hole 12 Thyroid cartilage piece 13 Thyroid cartilage 14 Vocal cord 20 Vocal dysfunction treatment tool 21 Fixing part 22 Main body part 23 Contact part 24 1st folding line 25 2nd folding line 26 Mounting hole 27 1st boundary line 28 2nd boundary line 29 Axis line 30 Push-in part 31 Opening part 32 Perichondrium
Claims (9)
チタン製の板状体であり、
一端に前記甲状軟骨に固定するための固定部と、
少なくとも２箇所に描かれた折曲線に沿って折曲可能な本体部と、を有し、
前記少なくとも２箇所に描かれた折曲線が、それぞれ複数の折曲線からなり、
前記少なくとも２箇所に描かれた折曲線における前記複数の折曲線からそれぞれ１つの折曲線を選択し、該選択した折曲線において前記本体部を折曲することにより形成される押込部の長さが調節可能であることを特徴とする発声障害治療具。 A dysphonia treatment tool used to treat glottal insufficiency by incising thyroid cartilage into a window and moving the affected vocal fold inward without passing through the incised thyroid cartilage piece,
It is a plate-shaped body made of titanium,
A fixing part for fixing to the thyroid cartilage at one end;
A foldable body portion, was perforated along a fold line drawn in at least two locations,
Each of the folding lines drawn in at least two places comprises a plurality of folding lines,
The length of the pushing part formed by selecting one folding line from each of the plurality of folding lines in the folding lines drawn in the at least two places, and bending the main body part in the selected folding line. A vocal dysfunction treatment device characterized by being adjustable .
前記第１の折曲線及び第２の折曲線が、それぞれ複数の折曲線からなり、
前記第１の折曲線及び前記第２の折曲線における前記複数の折曲線からそれぞれ選択した１つの折曲線と、発声障害治療具の軸線とがなす劣角が、７０度〜８０度である請求項１に記載の発声障害治療具。 The folding curves drawn in at least two places are the first folding curve and the second folding curve,
Each of the first fold line and the second fold line is composed of a plurality of fold lines,
The minor angle formed by one fold line selected from the plurality of fold lines in the first fold line and the second fold line and the axis of the speech disorder treatment tool is 70 degrees to 80 degrees. The speech disorder therapeutic device according to Item 1.
チタン製の板状体であり、
一端に前記甲状軟骨に固定するための固定部と、
他端に前記甲状軟骨と当接する当接部と、
前記固定部と前記当接部の間に、前記固定部側から順に第１の折曲線及び第２の折曲線が描かれ、該第１の折曲及び第２の折曲がそれぞれ複数の折曲線からなり、かつ前記第１の折曲線及び前記第２の折曲線に沿って折曲可能な本体部と、を有してなり、
前記第１の折曲線及び第２の折曲線における複数の折曲線からそれぞれ１つの折曲線を選択し、該選択した折曲線において前記本体部を折曲することにより形成される押込部の長さが調節可能であり、
前記固定部と前記本体部との間に描かれた第１の境界線に沿って谷折りし、前記第１の折曲線に沿って山折りし、前記第２の折曲線に沿って山折りし、前記本体部と前記当接部との間に描かれた第２の境界線に沿って谷折りしてなることを特徴とする発声障害治療具。 A dysphonia treatment tool used to treat glottal insufficiency by incising the thyroid cartilage into a window and moving the affected vocal fold inward without going through the incised thyroid cartilage piece,
It is a plate-shaped body made of titanium,
A fixing part for fixing to the thyroid cartilage at one end;
An abutting part that abuts the thyroid cartilage at the other end;
A first fold line and a second fold line are drawn between the fixed part and the abutting part in order from the fixed part side, and each of the first fold line and the second fold line includes a plurality of fold lines . And a main body that can be bent along the first and second folding lines.
The length of the pushing portion formed by selecting one folding curve from each of the plurality of folding curves in the first folding curve and the second folding curve, and bending the main body at the selected folding curve. Is adjustable,
Fold along the first boundary line drawn between the fixed portion and the main body, fold along the first fold, and fold along the second fold And a vocal dysfunction treatment tool which is formed by valley-folding along a second boundary line drawn between the main body and the contact portion.
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| US11523908B2 (en) * | 2016-12-29 | 2022-12-13 | Nobelpharma Co., Ltd. | Dysphonia treatment tool |
| WO2018230613A1 (en) * | 2017-06-14 | 2018-12-20 | ノーベルファーマ株式会社 | Tool for molding dysphonia treatment tool, and method for bending front piece of dysphonia treatment tool |
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| EP0453186B1 (en) * | 1990-04-20 | 1993-11-03 | SMITH & NEPHEW RICHARDS, INC. | Phonosurgery devices |
| US5201765A (en) * | 1991-09-20 | 1993-04-13 | Xomed-Treace Inc. | Vocal cord medialization prosthesis |
| US5197982A (en) * | 1991-10-15 | 1993-03-30 | Goldsmith Iii Manning M | Adjustable prosthetic device for vocal cord and method |
| US5306298A (en) * | 1993-02-16 | 1994-04-26 | Godley Iii Frederick A | Adjustable laryngoplasty device |
| CA2154102C (en) * | 1995-07-18 | 2003-10-07 | Christian Ahmarani | Vocal cord medializing device |
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