WO2015111340A1

WO2015111340A1 - Dysphonia treatment implement

Info

Publication number: WO2015111340A1
Application number: PCT/JP2014/083845
Authority: WO
Inventors: 康二松島
Original assignee: 学校法人東邦大学
Priority date: 2014-01-27
Filing date: 2014-12-22
Publication date: 2015-07-30
Also published as: JPWO2015111340A1; JP6434921B2

Abstract

　Provided is a dysphonia treatment implement used for treating incomplete glottal closure by incising a window shape in the thyroid cartilage and moving affected vocal cords to the inside while bypassing the incised thyroid cartilage, the dysphonia treatment implement having a titanium plate as a fixing part for fixing at one end thereof to the thyroid cartilage, and a main body part capable of bending along bend lines drawn in at least two locations.

Description

Voice disorder treatment device

The present invention relates to a speech disorder treatment device.

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.

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.

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 with a thickness of 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.

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) 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) 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.

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.

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 has a larger mounting hole 11 with a diameter of 2 mm than the nylon thread of 2-0 size (thickness of about 0.2 mm) used for the 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.

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.

This invention makes it a subject to solve the said various problems in the past and to achieve the following objectives. 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.

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.

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.

FIG. 1A is a photograph showing a Friedrich implant. FIG. 1B is a photograph showing a Friedrich implant attached to thyroid cartilage. FIG. 2 is a diagram for explaining a problem in Friedrich's implant. FIG. 3 is another view for explaining a problem in Friedrich's implant. FIG. 4A is a photograph showing the cutting position in front of the vocal cord membrane-like part. FIG. 4B is a cross-sectional photograph taken along line XX in FIG. 4A. FIG. 4C is a photograph showing the cutting position behind the vocal cord membrane-like part. 4D is a cross-sectional photograph taken along line YY in FIG. 4C. FIG. 5 is a schematic diagram showing a Friedrich implant attached to thyroid cartilage. FIG. 6A is a photograph before the Friedrich implant is attached to the thyroid cartilage. FIG. 6B is a photograph after the Friedrich implant is attached to the thyroid cartilage. FIG. 7 is a schematic perspective view showing an example of an old titanium plate. FIG. 8 is a schematic view showing a state in which the old titanium plate is attached to the thyroid cartilage. FIG. 9A is a photograph showing an example of a titanium plate which is a speech disorder treatment device of the present invention. FIG. 9B is a plan view showing an example of a titanium plate that is a speech disorder treatment device of the present invention. FIG. 9C is a partially enlarged view of the main body of FIG. 9B. FIG. 10 is a side view showing an example of a folded state of a titanium plate that is a speech disorder treatment device of the present invention. FIG. 11 is a photograph showing an example of a state in which a titanium plate, which is a speech disorder treatment device of the present invention, is attached to thyroid cartilage. FIG. 12 is a schematic view showing an example of a state in which a titanium plate which is a speech disorder treatment device of the present invention is attached to thyroid cartilage. FIG. 13A is a schematic front view showing a state in which the endochondral membrane detached from the thyroid cartilage and the structure inside the larynx are parallel to the thyroid cartilage. FIG. 13B is a schematic side view showing a state in which the endochondral membrane peeled from the thyroid cartilage and the structure inside the larynx are parallel to the thyroid cartilage. FIG. 14A is a schematic front view showing a state in which the endochondral membrane peeled from the thyroid cartilage and the structure inside the larynx are curved in an arcuate shape. FIG. 14B is a schematic side view showing a state in which the endochondral membrane peeled from the thyroid cartilage and the structure inside the larynx are curved in an arcuate shape. FIG. 15 is a schematic view showing a state in which the tip of the inserted old titanium plate is inclined in the immediate direction of the center of the head and tail side and the abdominal back side of the thyroid cartilage. FIG. 16 is a coronal cut image of cervical CT after surgery showing that a titanium plate of a 62-year-old male patient is placed in parallel with the vocal cords. FIG. 17 is a coronal section image of a cervical CT after surgery showing that a titanium plate of a 66-year-old male patient is placed in parallel with the vocal cords. FIG. 18 is a coronal section image of cervical CT after surgery showing that a titanium plate of a 66-year-old male patient is placed in parallel with the vocal cords. FIG. 19 is a coronal section image of cervical CT after surgery showing that a titanium plate of a 72-year-old male patient is placed in parallel with the vocal cords. FIG. 20 is a coronal cut image of cervical CT after surgery showing that a titanium plate of an 84-year-old male patient is placed in parallel with the vocal cords. FIG. 21A is a three-dimensional front view of the neck after surgery of the same 62 year old male patient as FIG. FIG. 21B is a three-dimensional side view of the neck after surgery of the same 62 year old male patient as FIG.

(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.

<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 4 types of Grade 1 to Grade 4. 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.

<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.

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.

<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.

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 speech disorder treatment tool are both 70 degrees to 80 degrees (dominant angle 100 degrees to 110 degrees), and 75 Degree (major angle 105 degrees) is preferable. Accordingly, it is possible to give an inclination of 10 degrees to 20 degrees as compared with the old titanium plate (90 degrees), and it is possible to push in the titanium plate that is the speech disorder treatment tool of the present invention in parallel with the vocal cords.

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.

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.
The length of the pushing portion is not particularly limited and may be appropriately selected depending on the intended purpose, but is preferably 8 mm to 14 mm. 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.

<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 intended 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.

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.

The length of the speech disorder treatment device is preferably 25 mm to 30 mm, and 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.

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.

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 inferior 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, it is possible to give an inclination of 10 degrees to 20 degrees compared to the old titanium plate (90 degrees), and the titanium plate can be pushed in parallel to the vocal cords.

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. By setting a tilt of 10 ° to 20 ° compared to the old titanium plate (90 °), 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.

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 arch 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 the angle is 70 degrees to 80 degrees, that is, the inclination is 10 degrees to 20 degrees 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 for 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.

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.

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.

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.

Examples of the present invention will be described below, but the present invention is not limited to these examples.

Example 1
Titanium plate shown in Fig. 9A to Fig. 9C [Wakayoshi Manufacturing Co., Ltd., Kanie City, Fukui Prefecture, March 2005, QMS (conforms to international standard ISO 13485) highly managed medical device class as a voice disorder treatment tool 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.

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.

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 the minor 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 dysphonia 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 voicing disorder 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.

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.

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

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;
And a body part that can be bent along folding lines drawn in at least two places.
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 and the axis of the speech disorder treatment tool are The dysphonia treatment device according to claim 1, wherein the minor angle formed is 70 degrees to 80 degrees.
3. The vocal dysfunction treatment device according to claim 1, wherein the fixing portion has at least two mounting holes.
4. The vocal dysfunction treatment device according to claim 1, wherein the average thickness is 0.15 mm or more and less than 0.25 mm.
Titanium plate is ASTM F67. The vocal dysfunction treatment device according to any one of claims 1 to 4, comprising pure titanium of Grade2.
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 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 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.
7. The vocal dysfunction treatment device according to claim 6, wherein a minor angle formed by each of the first fold curve and the second fold curve and the axis of the dysphonia treatment device is 70 degrees to 80 degrees.
In advance, the valley is folded along the first boundary line, and the mountain is 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 speech disorder treatment device according to any one of claims 6 to 7, wherein the pushing portion is formed by mountain folding.
The vocal dysfunction treatment device according to claim 8, wherein the length of the pushing portion is 8 mm to 14 mm.