Vocal cord treatment implant and vocal cord treatment system

Abstract

This vocal cord treatment implant is used in a state of being attached to a vocal cord, and comprises: a plate formed by a cutting process; and a spacer attached to the plate. The plate includes a pressing part, a base part connected to a first end of the pressing part, and a spacer attachment part connected to a second end of the pressing part. The spacer has a footing part, and a column part that extends from the footing part, and is fixed to the spacer attachment part.

Description

Implants and systems for vocal cord treatment

[0001] This invention relates to an implant for vocal cord treatment. It also refers to a vocal cord treatment system comprising a plurality of devices including this vocal cord treatment implant. This application claims priority to Japanese Patent Application No. 2024-159472, filed in Japan on September 13, 2024, the contents of which are incorporated herein by reference.

[0002] The vocal cords are the organs responsible for vocalization, located in the center of the larynx. The vocal cords produce sound (voice) by allowing air exhaled from the lungs to pass through the gap between the opening and closing folds of the left and right vocal cords, causing vibrations. The recurrent laryngeal nerve controls this movement of the vocal cords. Due to recurrent laryngeal nerve paralysis (vocal cord paralysis), trauma, cancer surgery, aging, etc., one vocal cord may become unable to adduct to the midline (closed position), or the entire vocal cord may atrophy, resulting in glottal insufficiency. This can lead to voice disorders such as air leakage and hoarseness (breathable dysphonia), and swallowing difficulties due to food or saliva dripping into the trachea. Surgical procedures to improve this type of glottal insufficiency include injecting autologous tissue (fat) or foreign material (bone paste, atelocollagen) into the paralyzed (affected) vocal cord to increase its volume and correct the gap, and injecting an external incision into the skin and pushing the vocal cord inward through the incised thyroid plate to correct the gap (so-called laryngoplasty).

[0003] Traditionally, to fix the affected vocal cord in an inward position, materials such as autologous cartilage, silicone implants, and stretched polytetrafluoroethylene (ePTFE) sheets have been used. Titanium implants are known as a promising material. Titanium implants have been reported by Friedrich of Austria, and in Japan, a group including the present inventor, Matsushima, published the first paper on the subject.

[0004] In Patent Document 1 related to the previous application of the inventor Matsushima, a voice disorder treatment device obtained by further improving the titanium implant reported in the above paper is disclosed. This voice disorder treatment device is a titanium plate-like body, and has a fixing portion provided at one end for fixing to the thyroid cartilage, and a main body portion that can be bent along bending lines drawn at at least two locations. A plurality of bending lines are provided at each location, and the length of the pushing-in portion can be adjusted by selecting the line to be actually bent.

[0005] Japanese Patent No. 6434921

[0006] The voice disorder treatment device described in Patent Document 1 is excellent in biocompatibility, long-term stability, and workability, and also has high versatility. The inventors have repeatedly studied while considering fully adapting to various individual differences of patients, and have also made improvements to the device used for indwelling, thereby completing the present invention.

[0007] An object of the present invention is to provide a vocal cord treatment implant that can be indwelt while fully adapting to various individual differences of patients. Another object of the present invention is to provide a vocal cord treatment system capable of indwelling the above vocal cord treatment implant with minimal invasion.

[0008] A first aspect of the present invention is a vocal cord treatment implant used by being attached to the vocal cords. This vocal cord treatment implant includes a plate formed by cutting, and a spacer attached to the plate. The plate has a pressing portion, a base portion connected to the first end portion of the pressing portion, and a spacer attachment portion connected to the second end portion of the pressing portion. The spacer has a scaffold portion, and a column portion that extends from the scaffold portion and is fixed to the spacer attachment portion.

[0009] A second aspect of the present invention is a vocal cord treatment system comprising a vocal cord treatment implant according to the first aspect, a first marker used to draw a line segment on the thyroid cartilage that will be the upper edge of the fenestration formed in the thyroid cartilage for the placement of the vocal cord treatment implant, and a second marker used to form spots on the thyroid cartilage that will be the four corners of the fenestration. The first marker has a body with a rail and a gauge attached to the rail. The second marker has an elongated body and a marking portion including a plurality of marking protrusions.

[0010] According to the present invention, it is possible to provide a vocal cord treatment implant that can be implanted while being sufficiently adapted to various individual differences in patients.

[0011] This figure shows a partial configuration of a vocal cord treatment implant according to one embodiment of the present invention. This is a front view showing the plate of the vocal cord treatment implant. This is a bottom view of the plate. This is a left side view of the plate. This is a perspective view showing the anchor of the vocal cord treatment implant. This is a figure for explaining the basic fenestration position in the thyroid cartilage. This is a figure showing one step of the procedure for forming a fenestration in the thyroid cartilage. This figure shows the first marker of the vocal cord treatment system according to one embodiment of the present invention. This is a figure showing one step of the fenestration procedure using the first marker. This figure shows the second marker of the vocal cord treatment system according to one embodiment of the present invention. This is a figure showing the first cauterization area of ​​the second marker. This is a view of the first cauterization area from a different direction. This is a figure showing one step of the fenestration procedure using the second marker. This is a figure showing one step of the procedure for forming a fenestration in the thyroid cartilage. This is a figure showing one step of the procedure for forming a fenestration in the thyroid cartilage. This is a figure showing the implantation body of the vocal cord treatment implant. This is a view of the implanted implantation body from the cephalic side. This is a figure showing one step of the operation for attaching the anchor. This is a figure showing the state after the placement of the vocal cord treatment implant is completed.

[0012] One embodiment of the present invention will be described with reference to Figures 1 to 18. The vocal cord treatment system according to this embodiment consists of a vocal cord treatment implant (hereinafter sometimes simply referred to as "implant") which is placed in the thyroid cartilage of the vocal cords, and two markers used in a series of procedures for placing this implant. First, the structure of the implant will be described, and then the structure and usage of the markers will be described together with the description of the implantation procedure.

[0013] Figure 1 shows a partial configuration of the implant according to this embodiment. The implant consists of three components: the plate 100 shown in Figure 1, the spacer 200, and the anchor, which will be described later. The front view, bottom view, and left side view of the plate 100 are shown in Figures 2, 3, and 4, respectively. As shown in Figures 2 to 4, the plate 100 is composed of a base 110 provided at one end, a pressing portion 120 protruding rearward from the base 110, and a spacer mounting portion 130 provided at the other end, all connected together.

[0014] The voice disorder treatment device described in Patent Document 1 above is configured to adjust the amount of protrusion of the part corresponding to the pressing part 120 (the distance between the base and the pressing part in the front-to-back direction of the plate) and the length of the pressing part (the dimension in the left-to-right direction) to suit the patient by bending a selected folding curve from an initial flat shape. In this embodiment, the plate appears in the figure to be a plate-like member that has been bent, but the shape shown in the figure is directly formed by cutting it out from a titanium block or the like. That is, the plate is provided in the illustrated state, and the user does not bend it when using it. For this reason, in one embodiment, multiple types of plates with different dimensions are prepared to accommodate dimensional variations due to individual differences in patients, and these are housed in the vocal cord treatment system. The number of plates housed in the system and the specific dimensions of each plate can be set as appropriate.

[0015] The base portion 110 is flat, and holes 111 are formed at two locations, upper and lower, near the end of the plate, penetrating in the front-to-back direction. The distance between the holes 111 in the plate 100 can be set as appropriate, but a distance of 4 mm or more is preferable as it allows for stable fixation to the thyroid cartilage. In this embodiment, in order to achieve this distance relationship, the vertical dimension of the base portion 110 is made larger than that of the pressing portion 120, and the base portion 110 is extended downward so as not to protrude excessively beyond the upper end of the pressing portion 120 when viewed from the front.

[0016] The pressing portion 120 is located behind the base portion 110 by being connected to a connecting portion 115 that extends rearward from the base portion 110. As shown in Figure 3, the base portion 110 and the connecting portion 115, and the connecting portion 115 and the pressing portion 120 are all roughly perpendicular to each other, so the base portion 110 and the pressing portion 120 are roughly parallel. Since the thickness of the plate 100 is, for example, about 0.2 mm, the angles they make can be manually adjusted within a certain range.

[0017] As shown in Figure 2, the upper edge of the pressing portion 120 slopes downward from the base portion 110 towards the spacer mounting portion 130 in a front view of the plate 100. The angle of inclination is approximately 20°. This takes into account the anatomical position of the paralyzed side of the vocal cords, which will be explained in more detail later.

[0018] The spacer mounting section 130 has a wall surface 131 extending forward from the end of the pressing section 120, and a pair of arms 132 fixed to the wall surface 131. The pressing section 120 and the wall surface 131 are also roughly at a right angle, but like the connection part between the base 110 and the connecting section 115, the angle can be manually adjusted within a certain range. The arms 132 extend toward the connecting section 115 from the surface facing the connecting section 115, then curve and approach each other. As a result, in a front view of the plate 100, the arms 132 have a shape like part of a cylinder extending in the front-rear direction.

[0019] The left side view of plate 100 shown in Figure 4 is generally similar to the position of plate 100 when viewed from the ventral side of the patient with the implant in place. In Figure 4, the dimensions of the connecting portion 115 in the anterior-posterior direction are longer at the upper end than at the lower end. As a result, the pressing portion 120 connected to the connecting portion 115 is inclined so that its upper side is positioned further back.

[0020] Achieving the aforementioned inclination angle of the upper edge of the pressing portion 120 in a front view, and the left side view shape of the connecting portion 115 simultaneously is impossible by simply bending a flat metal member, and is difficult to actually manufacture without the plate of this embodiment, which is directly formed by cutting.

[0021] As shown in Figure 1, the spacer 200 has a flat scaffold portion 210 and a column portion 220 connected to the scaffold portion 210. The scaffold portion 210 is provided with at least one through hole 211 through which a surgical suture can be passed. The column portion 220 in this embodiment has a cylindrical appearance and dimensions that allow it to enter between a pair of arms 132 of the plate 100. The column portion may be solid (rod-shaped) or hollow (tubular). Figure 1 shows three types of spacers 200: spacer 200A, spacer 200B, and spacer 200C. These spacers have a common scaffold portion 210, differing only in the length of the column portion 220. Therefore, by selecting the spacer to be attached to the plate 100, the position of the pressing portion 120 when the implant is placed can be adjusted. The number of spacers included in the vocal cord treatment system is not limited to three; there may be four or more, or two or fewer.

[0022] Figure 5 shows the anchor 300. The anchor 300 has a plate-shaped main body 310 and a claw portion 320 connected to the main body 310. The main body 310 in this embodiment has a shape in which one end of a substantially rectangular plate-shaped member is gently bent by about 90° in the thickness direction, and the cross-section in the thickness direction is J-shaped. A through hole 311 for passing surgical sutures is provided in the flat part of the main body 310. The claw portion 320 in this embodiment has two claws 321 provided at the bent end of the main body 310. Each claw 321 is pyramidal and extends generally parallel to the part of the main body 310 where the through hole 311 is provided, at a certain distance from it, with one of the edges of the triangular pyramid facing the part where the through hole 311 is provided. The number and arrangement of claws 321 in the claw portion 320, the shape of each claw, etc. can be determined as appropriate.

[0023] The plate 100, spacer 200, and anchor 300, which are components of the implant described above, are all made of titanium. Pure titanium is preferred as the material. Pure titanium is classified into four types in Japan according to JIS H4600 Grades 1 to 4, and in the United States according to ASTM F67 Grade 1 to Grade 4, based on its chemical composition and mechanical properties. Among these, pure titanium of ASTM F67 Grade 2 (equivalent to JIS H4600 Grade 2) is preferred because it has a good balance of processability and strength and is the most widely used as a medical device.

[0024] The vocal cord treatment implant and vocal cord treatment system according to this embodiment are used in thyroplasty type I, a type of laryngoplasty. Thyroplasty type I is performed alone or in combination with arytenoid adduction. The implant is placed in the space surrounded by the thyroid cartilage located around the vocal cords, and presses against the paralyzed vocal cord, holding it in a position close to the midline. The procedure for thyroplasty type I using the implant according to this embodiment will be described below, along with the configuration of other instruments used.

[0025] First, a horizontally elongated rectangular hole (fenestration) is made in the thyroid cartilage for implant placement. The basic position of the fenestration has been determined based on anatomical landmarks since this procedure was first performed. Specifically, in the lateral view of the thyroid cartilage Tc shown in Figure 6, the upper edge of the fenestration W is typically set along line L2, which is parallel to line L1 connecting the lower end P1 of the midline and the lower notch P2, and passes through the midpoint P3 of the midline.

[0026] The above setting is based on the clinical finding that the line L2 is roughly at the same height as the upper surface of the vocal cords. However, in a study by inventor Matsushima using CT to examine the position of the anterior commissure (the site where the vocal cords attach to the thyroid cartilage) in 46 cases, approximately 70% (32 cases) had the anterior commissure at a position higher than line L2, with the most common position being about 1-2 mm higher than line L2. Therefore, in this embodiment, while following the above standard approach using line L2, the height of the upper edge of the fenestration is adjusted to suit the position of the vocal cords of each individual patient.

[0027] First, the user, such as a physician, obtains a tomographic image of the thyroid cartilage Tc along the midline using cervical CT to determine the position of the patient's vocal cords. Furthermore, the distance from the lower end of the midline to the vocal cords is measured, and as shown in Figure 7, the position P4 at the height of the vocal cords on the midline is marked using a surgical dye or the like.

[0028] Next, the first marker is used to draw a line (the line segment WL described later) on the thyroid cartilage Tc that will be the upper edge of the opening W. Figure 8 shows the first marker 400. The first marker 400 has an elongated body 410 and a plurality of gauges 420 that can be selectively attached to the body 410. There are no particular restrictions on the material of the body 410 and the gauges 420, but metals such as stainless steel or titanium are preferred from the viewpoint of dimensional stability against temperature and sterilization resistance.

[0029] The main body 410 has a rectangular prism-shaped rail 411 and a wide grip 412 provided at one end of the rail 411. In this embodiment, the grip 412 is angled with respect to the rail 411 to improve handling, but this is not essential, and the grip 412 may be located on the extension of the rail 411. On the end of the rail 411 on the side where the grip 412 is not provided, a projection 413 extending downward is provided. The first marker 400 of this embodiment has five gauges 420A to 420E. Each gauge has a horizontally extending base 421 and two descending portions 422 extending from both ends of the base 421. Each descending portion 422 has a pair of L-shaped guides 423 extending backward. The rail 411 of the main body 410 can pass through the space surrounded by the guides 423, thereby allowing the gauge 420 to slide relative to the main body 410 without significant rattle. Each gauge has the same dimensions and shape for the descending section 422 and guide 423, as well as the same left-right dimensions for the base 421, while the vertical dimensions of the base 421 differ in 1 mm increments. The gauge lineup in this embodiment is merely an example, and the number of gauges and the units of the difference in the vertical dimensions of the base 421 can be determined as appropriate.

[0030] The user selects one gauge that they deem optimal based on the position of the vocal cords they have located, and passes the rail 411 of the main body 410 through the guide 423. The projection 413 of the main body 410 extends downward and behind the rail 411, but since the rail 411 is provided with a guide groove, the gauge 420 can be attached to the main body 410 without interfering with the projection 413.

[0031] Next, the user places the first marker 400, to which the gauge is attached, against the thyroid cartilage Tc as shown in Figure 9. More specifically, the projection 413 is inserted into the lower notch P2 of the thyroid cartilage Tc, and the first marker 400 is positioned so that the upper edge of the rail 411 is at approximately the same height as the lower edge of the thyroid cartilage Tc. The lower edge of the thyroid cartilage Tc and the upper edge of the rail 411 can be seen from the space below the base 421 and between the descending portions 422 of the gauge 420 attached to the main body 410, making it easy to align the upper edge of the rail 411 with the lower edge of the thyroid cartilage Tc.

[0032] When the first marker 400 is placed on the thyroid cartilage Tc in this manner, the upper edge of the rail 411 roughly coincides with the line L1 described above, and the distance from the lower end of the thyroid cartilage Tc to the upper edge of the gauge 420 becomes equal to a predetermined value, specifically the number (mm) indicated on the gauge. Therefore, the user can attach the gauge 420, which has the same numerical value (mm) as the distance (mm) from the lower end of the midline to the vocal cords in the patient, to the main body 410, place the first marker 400 on the thyroid cartilage Tc as described above, and draw a line along the upper edge of the gauge using a surgical dye or the like, thereby drawing a line segment WL parallel to line L1 on the thyroid cartilage Tc at the height of position P4 (Step A). ​​The line segment WL is roughly parallel to the line L2 described above, and its height is adjusted based on the position of the patient's vocal cords. Therefore, by using the first marker 400, the user can draw a line on the thyroid cartilage Tc that will be the upper edge of the fenestration W optimized for the patient.

[0033] Next, the user uses the second marker to mark the four corners of the opening W on the thyroid cartilage Tc. Figures 10, 11A, and 11B show the second marker according to this embodiment. The second marker 500 of this embodiment is made entirely of metal and has a first cauterization portion 520 and a second cauterization portion 530 at both ends in the longitudinal direction of the elongated body 510, respectively, as marking portions.

[0034] The main body 510 shown in Figure 10 is slightly thicker in the middle than at both ends in the longitudinal direction, but this is not essential, and the shape of the main body 510 may be determined as appropriate considering ease of gripping, etc. The first cauterizing portion 520 has a rectangular plate-like portion 521 and six marking protrusions 522 protruding from the plate-like portion 521, as shown in Figures 11A and 11B. The short side dimension of the plate-like portion 521 in this embodiment is approximately the same as the short side dimension of the opening window W, and the long side dimension is approximately the same as the distance from the midline of the thyroid cartilage to the apex of the opening window W furthest from it. The plate-like portion is fixed to the main body 510 such that the connected main body 510 extends in the direction normal to the plate-like portion 521.

[0035] In this embodiment, the marking projection 522 is provided on the peripheral edge of the plate-shaped portion 521 on the side to which the main body 510 is not connected. That is, the marking projection 522 protrudes in a direction away from the main body 510. The marking projection 522 consists of two reference projections 522a and four window-opening projections 522b. The reference projections 522a are located at the two corners corresponding to both ends of one short side of the plate-shaped portion 521. The two window-opening projections 522b are located at the two corners corresponding to both ends of the other short side of the plate-shaped portion 521, and the remaining two are arranged together with these two to form the four vertices of a rectangle that is the same shape and size as a standard window W.

[0036] An arrow 521a is provided on the surface of the plate-shaped portion 521 facing the main body 510, indicating the side where the reference projection 522a is located. There are no particular restrictions on the direction in which the arrow 521a is formed, but from the viewpoint of contacting the incised biological tissue, it is preferable to form it by engraving using a laser or the like. Although not shown in Figures 11A and 11B, the configuration of the second cauterization portion 530 is similar, and it has a plate-shaped portion and six marking projections. While the first cauterization portion 520 is intended primarily for males, the second cauterization portion 530 is intended primarily for females, so the only difference between the second cauterization portion 530 and the first cauterization portion 520 is that the dimensions of the rectangle formed by the plate-shaped portion and the window-opening projections are slightly smaller.

[0037] When using the second marker 500, the user grasps the main body 510 and brings the first cauterization section 520 or the second cauterization section 530, selected according to the patient, close to the thyroid cartilage Tc, as shown in Figure 12. First, while holding the upper edge of the plate-like section 521 (in the case of the first cauterization section 520) at approximately the same height as the line drawn using the first marker 400, the cranial reference projection 522a is brought into contact with the marked position P4 on the thyroid cartilage Tc. Next, using the contacted reference projection 522a as a fulcrum, the plate-like section 521 is tilted backward, and the four window-opening projections 522b come into contact with the thyroid cartilage Tc (more precisely, the membrane surrounding the thyroid cartilage) while the height of the upper edge is maintained. The thyroid cartilage Tc has a bowl-shaped form that opens upwards, and its outer surface is curved. Therefore, when the reference projection 522a is brought into contact with the thyroid cartilage Tc, the fenestration projection 522b does not make contact, and when the fenestration projection 522b is brought into contact with the thyroid cartilage Tc, the reference projection 522a does not make contact. Consequently, when using the second marker 500, it is basically impossible for all six marking projections 522 to make contact with the thyroid cartilage Tc at the same time.

[0038] When the second marker 500 is energized while the four fenestration projections 522b are in contact with the thyroid cartilage Tc, the membrane at the site of contact with the fenestration projections 522b discolors due to heat, and four dark spots appear on the outer surface of the thyroid cartilage Tc. The second marker 500 according to this embodiment does not have a structure such as wiring for conducting electricity or a connector for connecting to a power source, but since the entire structure is made of a conductor, it can be easily energized by, for example, bringing the tip of an electrosurgical unit used in the procedure into contact with the second marker 500. The method of forming spots using the second marker is not limited to the above. For example, spots may be formed by applying a medical dye to the fenestration projections 522b and pressing them against the thyroid cartilage Tc.

[0039] Figure 13 shows the thyroid cartilage Tc after spots have been formed with the second marker 500. In Figure 13, the two upper spots WS are difficult to see as they lie on the line segment WL drawn using the first marker, but the two lower spots WS are clearly visible. In other words, by using the second marker 500, four spots can be easily formed along the line segment WL (Step B). The formed spots are easily identifiable even when they lie on the line segment WL. Subsequently, by connecting the four spots with straight lines, a horizontal rectangular outline OL for forming the window is completed, as shown in Figure 14. The upper long side of this outline OL lies along the line segment WL, which is optimally set to match the height of the patient's vocal cords. Furthermore, because it is formed while being positioned using the reference projection 522a, even inexperienced users can accurately create the outline OL at a predetermined distance from the midline of the thyroid cartilage Tc by using the first marker 400 and the second marker 500.

[0040] The user excises the thyroid cartilage along the outline OL to form a fenestration W (step C). In foreign-made voice disorder treatment systems currently used outside of Japan, it is necessary to process and remove a certain range of the extrinsic laryngeal muscles attached to the thyroid cartilage when forming the fenestration W, and in some products, it is necessary to remove a considerably dorsal area. This can lead to a decrease in swallowing function after surgery, negatively impacting QOL (quality of life), or an increase in postoperative bleeding. The series of procedures described above using the first marker 400 and the second marker 500 can be performed without problems even with the extrinsic laryngeal muscles attached, so the fenestration W can be formed by removing only a small amount of muscle that is attached to the outline OL as needed when excising the thyroid cartilage. Therefore, compared to the foreign-made systems mentioned above, the amount of muscle to be processed can be significantly reduced, and type I thyroplasty can be performed minimally invasively while suppressing bleeding.

[0041] Next, the user places the implant using the formed opening W. As a preparatory step, an extensor or the like is inserted through the opening W, and the patient, who is awake under local anesthesia, is asked to vocalize while the amount of vocal cord compression is varied. Through this process, the appropriate amount of vocal cord compression for that patient is determined. Based on the determined amount of compression, the user selects one plate 100 and one spacer 200. The scaffold portion 210 of the spacer 200 is positioned in a predetermined position, and the column portion 220 is inserted into the arm 132 of the spacer mounting portion 130 and abutted against it. After that, the arm 132 is tightened and deformed with forceps or the like, so that the spacer 200 becomes the implantation body 10 fixed to the plate 100, as shown in Figure 15. The implant 1 according to this embodiment is composed of this implantation body 10 and the anchor 300 described above. The implantation body 10 according to this embodiment has variations equivalent to the product of the number of plates 100 and spacers 200 in the lineup, by changing the plates 100 and spacers 200 that it is combined with. Therefore, fine adjustments can be made according to the patient's anatomical situation and pathological condition, and the optimal dimensions and shape for that patient can be easily achieved.

[0042] The user makes a hole in the thyroid cartilage Tc, passes a surgical suture through this hole and the hole 111 in the implantation body 10, then places the base 110 on the ventral edge of the opening W, and inserts the remaining part into the interior through the opening W. After that, the surgical suture is tied, fixing the base 110 to the thyroid cartilage Tc, while the remaining part is placed in the space surrounded by the thyroid cartilage Tc (step D). Figure 16 shows the positional relationship of the implanted implantation body 10 as seen from the head side. The state as seen from the head side is similar to the voice disorder treatment device described in Patent Document 1, but the shape as seen from the ventral side is different as described above. In the implantation body 10, as shown in Figure 4, the dimensions of the connection part 115 of the plate 100 in the anterior-posterior direction are longer on the upper side than on the lower side. Therefore, the pressing part 120 presses more firmly on the upper side of the implantation body 10, that is, the part closer to the membranous part of the vocal cords, so that the vocal cords can be effectively closed. On the other hand, in the voice disorder treatment device described in Patent Document 1, the portion corresponding to the connecting part 115 tends to become longer on the lower side than on the upper side due to the bending process. Therefore, there is a possibility that the part that is far from the membranous part and does not contribute much to closing the vocal cords will be pushed in further, and thus the implant according to this embodiment has advantages that the voice disorder treatment device described in Patent Document 1 does not have.

[0043] Next, the anchor 300 is attached. The user brings the anchor 300 close to the cricoid cartilage Cc located below the thyroid cartilage Tc, with the side with the claw portion 320 facing it, and pushes the cricoid cartilage Cc from below the cricoid cartilage Cc between the claw portion 320 and the main body portion 310. Then, the ridge of the claw portion 320 bites into the cricoid cartilage Cc, and as shown in Figure 17, the anchor 300 is attached to the cricoid cartilage Cc (step E). The user inserts a needle into the cricoid cartilage Cc and ligates the surgical thread Th1 through the cricoid cartilage Cc and the through hole 311 to secure the anchor 300 so that it does not fall off. Furthermore, as shown in Figure 18, another surgical thread Th2 is passed through the through hole 211 of the spacer 200 and the through hole 311 of the anchor 300 and ligated in a loop. This connects the anchor 300 to the implant body, and the dorsal end of the implant body, located within the space surrounded by the thyroid cartilage, is supported by the anchor 300 via a loop-shaped surgical suture Th2 (step F). With this, the implantation of implant 1 is completed.

[0044] In this way, the main part of type I thyroplasty using the vocal cord treatment system according to this embodiment, which includes the implant 1, the first marker 400, and the second marker 500, is completed. The user checks the patient's vocalization status and the like, performs necessary fine adjustments and post-treatment, and then closes the wound to end the series of procedures.

[0045] The vocal cord treatment system according to this embodiment enables the type I thyroplasty surgery to be performed in a minimally invasive manner and to sufficiently accommodate individual differences among patients, thus greatly contributing to the treatment of glottic insufficiency patients.

[0046] The implant 1 according to this embodiment has further advantages in addition to the various advantages described above as compared with the voice disorder treatment device according to Patent Document 1. One of them is that the pressing portion 120 of the plate 100 is inclined more greatly toward the dorsal side in a front view. The membranous portion of the vocal cord has been considered to be in a generally horizontal state for a long time. However, in a study by inventor Matsushima who confirmed the posture of the membranous portion using CT for 31 cases, even on the healthy side that was not paralyzed, it was inclined downward by about 14° toward the dorsal side on average. On the paralyzed side, due to the relaxation of the muscles, an average inclination of about 19°, which is larger than that of the healthy side, occurred. Based on this, in this embodiment, by manufacturing the plate 100 by cutting, the inclination angle of the pressing portion 120 is set to 20°, which is impossible with bending, to realize correspondence with the above-described actual inclination. As a result, the pressing portion 120 of the indwelling body 10 is configured to be easily arranged in a state close to parallel to the running of the membranous portion of the paralyzed-side vocal cord of the patient.

[0047] Another is having the anchor 300. Implants for vocal cord treatment currently in clinical use, including those described in Patent Document 1 and those made overseas, are placed in a form where the dorsal end disposed inside the thyroid cartilage is not fixed. Since there are muscle tissues etc. inside the thyroid cartilage, the posture of the implant during placement is not extremely unstable due to not being fixed. However, in the implant 1 according to this embodiment, by having the anchor 300, the placement main body 10 can be supported at both the ventral and dorsal ends, specifically at a total of three points, two points on the ventral side and one point on the dorsal side, so that the posture during placement can be made more stable.

[0048] Furthermore, the anchor 300 can also function to adjust the inclination of the pressing portion 120 in the placed state. Although it has already been explained that the membranous portion of the vocal cord is inclined so as to be lower toward the dorsal side, in actual patients, due to individual differences, the paralyzed side vocal cord may be inclined by 20° or more, or the thyroid cartilage may be inclined with respect to the standard posture. It is quite conceivable that there are cases where it is desirable to place the placement main body 10 in a state where the pressing portion 120 is further inclined toward the dorsal side. In such a case, by making the loop of the surgical thread Th2 stretched between the spacer 200 and the anchor 300 smaller, the dorsal end of the placement main body 10 can be pulled downward to perform adjustment to incline the pressing portion 120 more. Thereby, it is possible to perform a technique that sufficiently accommodates individual differences for a wider variety of patients.

[0049] When the implantation body 10 and anchor 300, which are fitted into the opening W, are fastened together with the surgical sutures without slack, a force acts on the thyroid cartilage Tc and cricoid cartilage Cc in a direction that brings them closer together. As the thyroid cartilage Tc approaches the cricoid cartilage Cc, a traction force acts on the vocal cords, which are supported by the thyroid cartilage Tc, in the anterior-posterior direction of the patient. As a result, the tension of the paralyzed vocal cords, which are sagging, increases, and the insufficient fixation of the arytenoid cartilage connected to the dorsal side of the vocal cords is reduced. This effect is similar to that obtained by arytenoid adduction surgery, but by using the vocal cord treatment system of this embodiment, a similar effect can be obtained without performing arytenoid adduction surgery, which requires advanced techniques. As a result, the vocal cord treatment system of this embodiment can contribute to the standardization and improvement of the effectiveness of surgical treatment of the vocal cords. To ensure or enhance the effects described above, the surgical suture passed through the anchor 300 may be passed through the hole 111 of the implantation body 10 or hooked onto the ventral edge of the opening W, thereby directly applying force to the anterior (ventral) side of the thyroid cartilage Tc.

[0050] Although one embodiment of the present invention has been described above, the specific configuration is not limited to this embodiment, and modifications and combinations of the configuration that do not depart from the spirit of the present invention are also included.

[0051] First, anchors are not essential in the vocal cord treatment system according to the present invention. As mentioned above, anchors exhibit many useful effects, but even with only the implantable body consisting of a plate and spacer, significant effects can be achieved compared to conventionally used voice disorder treatment devices.

[0052] Furthermore, in each component of the implant, the inner surface of the hole through which the surgical suture is passed may be chamfered to prevent the suture from breaking due to friction.

[0053] Since the second marker only needs to be able to conduct electricity to the cauterizing parts such as the first and second cauterizing sections, the cauterizing section may be made of a conductor, while the rest of the body may be made of an insulator.

[0054] The implant, first marker, and second marker described in the above embodiment can all be used in reverse, making them ambidextrous and gender-neutral, usable regardless of whether the paralyzed side is left or right. In the vocal cord treatment implant and vocal cord treatment system according to the present invention, such a dual-purpose configuration is not essential; for example, a configuration that can be used only on one side, or a configuration specialized for one gender, may also be used. Of course, an ambidextrous and gender-neutral configuration is naturally preferred.

[0055] The present invention includes the following technical concepts. (Note 1) A method for treating vocal cords using a vocal cord treatment system comprising a vocal cord treatment implant, a first marker, and a second marker, wherein the vocal cord treatment implant comprises a plate formed by cutting and a spacer attached to the plate, the plate comprises a pressing portion, a base connected to the first end of the pressing portion, and a spacer attachment portion connected to the second end of the pressing portion, the spacer comprises a scaffold portion and a column portion extending from the scaffold portion and fixed to the spacer attachment portion, the first marker comprises a body having a rail and a gauge attached to the rail, the second marker comprises an elongated body and a marking portion including a plurality of marking protrusions, the method for treating vocal cords comprising: step A drawing a line segment on the thyroid cartilage that will be the upper edge of an opening formed in the thyroid cartilage for implanting the vocal cord treatment implant using the first marker, and step B forming spots that will be the four corners of the opening on the thyroid cartilage along the line segment using the second marker.

[0056] (Note 2) A vocal cord treatment method as described in Note 1, wherein the vocal cord treatment system further comprises an anchor attached to the cricoid cartilage to support the spacer, and includes the steps of: forming the opening in the thyroid cartilage along the line segment; attaching the plate with the spacer attached to the spacer attachment portion to the opening; attaching the anchor to the cricoid cartilage; and connecting the spacer and the anchor.

[0057] This invention can be applied to vocal cord treatment implants and vocal cord treatment systems primarily targeting glottal insufficiency.

[0058] 1. Implant for vocal cord treatment 100 Plate 110 Base 120 Pressing part 130 Spacer mounting part 200, 200A, 200B, 200C Spacer 210 Scaffold part 220 Column part 300 Anchor 400 First marker 410 Main body 411 Rail 420, 420A, 420B, 420C, 420D, 420E Gauge 500 Second marker 510 Main body 520 First cauterization area (marking part) 522a Reference projection (marking projection) 522b Window opening projection (marking projection) 530 Second cauterization area (marking part) Cc Cricoid cartilage Tc Thyroid cartilage W Window opening WS Spot WL Line segment

Claims

1. A vocal cord treatment implant used by being attached to the vocal cords, comprising: a plate formed by cutting; and a spacer attached to the plate, wherein the plate has a pressing portion; a base portion connected to the first end of the pressing portion; and a spacer attachment portion connected to the second end of the pressing portion, and the spacer has a scaffolding portion; and a column portion extending from the scaffolding portion and fixed to the spacer attachment portion, the vocal cord treatment implant.

2. The upper edge of the pressing portion is inclined at an angle greater than 15° in a front view of the plate, such that it becomes lower toward the side where the spacer mounting portion is provided, as described in claim 1.

3. The vocal cord treatment implant according to claim 1, further comprising an anchor attached to the cricoid cartilage to support the spacer.

4. A vocal cord treatment system comprising: a vocal cord treatment implant according to any one of claims 1 to 3; a first marker having a body with a rail and a gauge attached to the rail, used to draw a line segment on the thyroid cartilage that will be the upper edge of an opening formed in the thyroid cartilage for the placement of the vocal cord treatment implant; and a second marker having an elongated body and a marking portion including a plurality of marking protrusions, used to form spots on the thyroid cartilage that will be the four corners of the opening.

5. The vocal cord treatment system according to claim 4, comprising a plurality of types of plates having different dimensions or shapes.

6. The vocal cord treatment system according to claim 4, comprising a plurality of types of spacers with different lengths of the column portion.

7. The vocal cord treatment system according to claim 4, comprising multiple types of gauges with different dimensions.

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