JP6751355B2 - Flange member - Google Patents

Description

The present invention relates to a flange member used with a tracheostomy tube.

Conventionally, for patients who have difficulty breathing spontaneously or who have difficulty discharging sputum by themselves, the trachea is incised at the throat, and a tracheostomy tube inserted into the trachea from the incision site is used to connect the body to the outside and inside the trachea. It is performed by directly connecting the above to facilitate the inhalation of foreign matter such as breathing and sputum. Such a tracheostomy tube is generally attached to a flange member and fixed to a human body such as a patient using this flange member.

For example, Patent Document 1 includes a cylindrical mounting portion that is a mounting portion of a tracheostomy tube, and a plate-shaped flange main body in which a string passage hole and a suture hole are provided at both ends sandwiching the mounting portion. A flange member is described. With this flange member, a string-like member such as a string or a belt is passed through string through holes provided at both ends of the flange body, and the string-like member for fixation can be wound around the neck to be fixed to the human body. In addition, for patients with a narrow neck (neck) or who can easily remove the tracheostomy tube, the flange member can be directly sutured to the skin with suture threaded through the suture hole and fixed to the human body. There is.

Special table 2011-525836 gazette

With a conventional flange member, when directly suturing and fixing the flange member to the skin using a suture thread, it is difficult to hang the suture thread between the pair of suture holes. It is general that the passed suture thread is hung over the outer peripheral edge of the flange member for suturing.

However, in such suturing, when a force is applied to the flange member, the suture thread hung on the outer peripheral edge moves along the outer peripheral edge and the flange member moves, so that the tracheostomy tube is There is a problem that it cannot be held at a predetermined position.

An object of the present invention is to solve such a point, and an object thereof is a flange member that can be securely fixed to a human body by suturing using a suture and can hold a tracheostomy tube at a predetermined position. Is to provide.

Flange member of the present invention is a flange member for use with a tracheostomy tube, a plate-shaped flange body with a suture locking recesses in the outer periphery provided with a sewing engagement hole, the tracheostomy tube is mounted And a mounting part to be mounted .

In the above configuration, the flange member of the present invention is preferably provided with the suturing hole and the suture thread locking recess at both left and right sides of the flange body with the mounting portion sandwiched therebetween.

In the above configuration, the flange member of the present invention is preferably provided with a pair of the suturing holes, which are vertically arranged on both left and right sides of the flange body with the mounting portion interposed therebetween.

In the above configuration, the flange member of the present invention is preferably provided with a pair of the suturing holes arranged side by side at left and right sides on both left and right sides of the flange body with the mounting portion sandwiched therebetween.

In the above configuration, the flange member of the present invention is preferably provided with the suture thread locking recesses at both upper and lower portions of the flange body.

It is preferable that the flange member of the present invention has the same number of the suture holes and the suture thread locking recesses in the above structure.

In the above configuration, the flange member of the present invention preferably has a reinforcing portion integrally provided on the surface of the flange body, the reinforcing portion being continuous with the opening of the stitching hole and protruding from the surface of the flange body.

In the above-mentioned configuration, the flange member of the present invention is preferably formed such that the stitching hole has a tapered shape in which the diameter gradually increases from the front surface to the back surface of the flange body.

In the above configuration, the flange member of the present invention is provided with string passing holes, through which the fixing string-like members are inserted, on both left and right sides of the flange body sandwiching the mounting portion, and the string passing hole is mainly An opening, a narrow width formed to have a vertical width smaller than that of the main opening, the narrow opening being provided outside the main opening, the main opening and the narrow opening being connected together, and the narrow width being narrowed. It is preferable that the connecting portion with the opening has a connecting opening portion whose vertical width is narrower than the vertical width of the narrow opening portion.

According to the present invention, it is possible to provide a flange member that is securely fixed to a human body by suturing using a suture and that can hold the tracheostomy tube at a predetermined position.

It is a figure shown in the state where the tracheostomy tube attached to the flange member which is one embodiment of the present invention was left indwelling in the trachea. It is a top view which shows the detail of the flange member shown in FIG. FIG. 3A is an enlarged view showing details of the string passing hole shown in FIG. 2, and FIG. 3B is a partially enlarged view in which a part of FIG. FIG. 3 is a cross-sectional view of the suture hole shown in FIG. 2. FIG. 3 is an enlarged view showing details of the suture thread locking recess shown in FIG. 2. It is a figure which shows roughly the fixing flange set which made the flange member and fixing cord-shaped member shown in FIG. 1 into a set. The state where the flange member is fixed to the body by the string-like member for fixing which has passed through the string-through hole, and (a) shows the state where the string-like member for fixing is passed through one narrow opening and locked. It is an explanatory view, and (b) is an explanatory view showing the state where the string-like member for fixation was spanned and locked so as to straddle two narrow width openings. It is explanatory drawing which shows the state which directly sewed the flange member to the skin by the suture thread which passed through the hole for stitching. It is a perspective view which shows the tube main body in the tracheostomy tube shown in FIG. 1 alone. (A) And (b) is each a side view of the tube main body shown in FIG. (A) And (b) is each a side view of the tube main body shown in FIG. (A) is a top view of a tube main body, (b) is a bottom view of a tube main body. FIG. 11 is a sectional view taken along line I-I of FIG. FIG. 11 is a sectional view taken along line II-II of FIG. It is sectional drawing which added the cuff to the III-III sectional view of FIG. 12 (a). It is the figure which looked at the tracheostomy tube shown in FIG. 1 from the base end side. It is a IV-IV sectional view of FIG. It is a figure which shows the modification of the 1st suction opening part in the tube main body of the tracheostomy tube shown in FIG. It is a flowchart figure which shows the procedure of the manufacturing method of a tube main body among the manufacturing methods of the tracheostomy tube shown in FIG. It is sectional drawing which shows a tracheostomy tube set. It is sectional drawing which shows the modification of the 2nd suction opening part shown in FIG.

Hereinafter, an embodiment of a flange member of the present invention will be described in detail with reference to the drawings. In the drawings, common members are designated by the same reference numerals.

As shown in FIG. 1, the flange member 1 of the present invention has a tracheostomy tube (tracheal tube) 101 attached thereto and is used together with the tracheostomy tube 101.

The tracheostomy tube 101 includes a tube body 102 and a cuff 103 that can be contracted and expanded on the outer peripheral surface of the tube body 102, and is attached to the flange member 1 at the proximal end portion of the tube body 102. The tracheostomy tube 101 is used by inserting the tube main body 102 into the trachea from the outside of the body through the incision portion of the throat. The flange member 1 fixes the tracheostomy tube 101 at a predetermined position by contacting the skin from outside the body when the tube body 102 is left in the trachea.

As shown in FIG. 2, the flange member 1 includes a mounting portion 2 and a flange body 3.

Here, in the flange member 1, when the flange member 1 is fixed to a human body in a predetermined posture, the head side (upper side in FIG. 2) is “upper side” and the foot side (upper side) when viewed from the front side of the human body. The lower side in FIG. 2 is the “lower side”, the left-hand side (the right side in FIG. 2) is the “right side”, and the right-hand side (the left side in FIG. 2) is the “left side”.

The mounting portion 2 is formed in a cylindrical shape, and the base end portion of the tube body 102 is inserted inside thereof. The tube body 102 is mounted on the flange member 1 while being fixed to the mounting portion 2 by, for example, press fitting (fitting) or adhesion. Therefore, when the flange member 1 is fixed to the human body, the tracheostomy tube 101 is fixed or held at a predetermined position by the flange member 1.

As shown in FIG. 1, the mounting portion 2 can be configured to have communication holes to which the suction tubes 119 and 120 are connected, but these communication holes are omitted in FIGS. 2 and 8 for convenience. Indicate. The configurations of the communication holes of the mounting portion 2 and the suction tubes 119 and 120 will be described later.

As shown in FIG. 2, the flange body 3 is formed in a plate shape that extends radially outward with respect to the mounting portion 2. The flange member 1 comes into contact with the skin on the back surface of the flange body 3 when the tube body 102 attached thereto is left in the trachea.

In the present embodiment, the flange body 3 is formed in a rectangular shape that slightly curves upward in FIG. The mounting portion 2 is provided at the center of the flange main body 3, and a portion of the flange main body 3 that extends toward the left side with respect to the mounting portion 2 is a left side portion 3a and a portion that extends toward the right side is a right side portion 3b. In this way, the flange member 1 has a bilaterally symmetrical shape with the mounting portion 2 as the center.

The flange body 3 is not limited to the above shape and may have any shape as long as it is formed in a plate shape that extends radially outward with respect to the mounting portion 2.

On both left and right sides of the mounting portion 2, a connecting body 4 having a thickness equal to or larger than that of the flange body 3 is integrally provided. When the thickness of the connecting body 4 is larger than the thickness of the flange body 3, the connecting strength can be further increased. Further, visual opening 5 is provided in each of the upper and lower sides of the mounting portion 2 of the flange main body 3, and the incised portion through which the tube main body 102 is inserted can be visually confirmed through the visual opening 5. It is like this. When the visual aperture 5 is provided, the connecting body 4 and the flange body 3 may be configured to move in an angle-variable manner about the major axis of the flange body 3 with respect to the mounting portion 2. The flange body 3 may be configured so that the connecting body 4 and the visual aperture 5 are not provided.

The left side portion 3a and the right side portion 3b of the flange body 3 are provided with string passing holes 10, respectively. The string passing hole 10 is a hole through which a fixing string-shaped member for fixing the flange member 1 to a human body is passed. Since the string passing hole 10 provided in the left side portion 3a of the flange body 3 and the string passing hole 10 provided in the right side portion 3b have the same shape except that they are bilaterally symmetric, the string passing hole 10 will be described below. The detailed shape will be described based on the string passing hole 10 provided in the right side portion 3b.

As shown in FIG. 3A, the string passage hole 10 is formed in a shape having a main opening 11, a narrow opening 12, and a connecting opening 13.

The string passing hole 10 may have a configuration in which at least one narrow opening 12 and the connecting opening 13 are provided for the main opening 11, but a plurality of narrow widths are provided for one main opening 11. The opening 12 and the connecting opening 13 may be arranged side by side in the vertical direction. In the present embodiment, the string passage hole 10 is provided with three narrow width openings 12 and three connecting openings 13 arranged in the vertical direction with respect to one main opening 11.

The main opening 11 is formed in an elongated hole shape extending in the up-down direction with a vertical width of about half of the flange main body 3, and constitutes a portion of the string passing hole 10 located closest to the mounting portion 2.

Each of the narrow openings 12 is formed in a circular shape whose vertical width is narrower than that of the main opening 11, that is, a circular shape whose diameter is smaller than the vertical width of the main opening 11. It is arranged on the side opposite to the mounting portion 2 with respect to the opening 11 with a gap.

The narrow opening 12 is not limited to the circular shape, and may have various shapes such as an elliptical shape and a rectangular shape as long as the shape has a narrower vertical width than the main opening 11.

In the present embodiment, the narrowest opening 12 that is arranged on the uppermost side of the three narrower openings 12 is arranged above the upper end of the main opening 11 and is the uppermost one of the three narrower openings 12. The narrow opening 12 arranged on the lower side is arranged below the lower end of the main opening 11, and the narrow opening 12 arranged in the middle of the three narrow openings 12 is the uppermost side. It is arranged in the middle between the narrow opening 12 and the narrowest opening 12 on the lowermost side. That is, the plurality of narrow openings 12 are arranged in a wider area in the vertical direction than the main opening 11.

Each of the three connecting openings 13 extends from the main opening 11 toward the corresponding narrow opening 12, and connects the main opening 11 and the corresponding narrow opening 12. In this embodiment, the narrowest opening 12 on the uppermost side is arranged above the upper end of the main opening 11, and the narrower opening 12 arranged on the lowermost side is below the lower end of the main opening 11. The narrow opening 12 arranged in the middle is also located between the uppermost narrow opening 12 and the lower narrow opening 12, so that the upper narrow width The connecting opening 13 corresponding to the opening 12 extends obliquely upward from the upper end of the main opening 11, and the connecting opening 13 corresponding to the lowermost narrow opening 12 is below the main opening 11. The connecting opening 13 extending obliquely downward from the end and corresponding to the middle narrow opening 12 extends straight from the intermediate position of the main opening 11 to the outside.

Each of the three connecting openings 13 is formed in a tapered shape in which the vertical width (interval between the inner surfaces 13a facing each other) gradually decreases from the main opening 11 side toward the narrow opening 12 side, The vertical width in the connecting portion with the narrow opening 12, that is, the vertical opening width in the connecting portion is narrower (smaller) than the vertical width of the narrow opening 12. In the illustrated case, the connecting opening 13 is formed in a linear taper shape in which the diameter is reduced at a constant rate, but it may be formed in a curved taper shape in which the diameter reduction rate is gradually changed.

The connecting opening 13 is not limited to the tapered shape, and if the vertical width in the connecting portion with the narrow opening 12 is narrower than the vertical width of the narrow opening 12, for example, a rectangular shape having a constant vertical width, or the like. It can also be formed in other shapes.

Further, the inner surfaces 13a of the adjacent connecting openings 13 are connected to each other at an acute angle. That is, between the adjacent connecting openings 13 of the flange body 3, an acute triangular portion projecting toward the main opening 11 side is formed.

In this way, the one main opening 11 and the three circular narrow openings 12 are connected by the tapered connecting opening 13, so that the string passing hole 10 has a substantially crown shape as a whole. There is.

The string passing hole 10 may be configured such that a pair of return pieces 14 are integrally provided at the connecting portions of the narrow opening 12 and the connecting opening 13. As shown in FIG. 3B, the return pieces 14 are formed in the shape of thin, acute-angled projections that extend along the inner surface 13 a of the connecting opening 13 and project into the narrow opening 12. .. That is, one outer surface 14a of the return piece 14 is continuous with the inner surface 13a of the connecting opening 13 in the same plane, and the other outer surface 14b is inclined to the outer surface 14a at an acute angle and is formed on the inner surface of the narrow opening 12. It is lined up. Since the outer surface 14a of the pair of return pieces 14 protruding inside the narrow opening 12 is formed in the same plane as the inner surface 13a of the tapered connection opening 13, the return piece 14 has a vertical direction at the tip thereof. The opening width of is smaller than the opening width in the up-down direction at the connecting portion of the connecting opening portion 13 with the narrow opening portion 12.

As shown in FIG. 2, the flange body 3 is provided with a suture hole 20. These suturing holes 20 are holes through which suture threads for fixing the flange member 1 to the human body by suturing are passed.

In the present embodiment, four stitching holes 20 are provided in each of the left side portion 3a and the right side portion 3b of the flange body 3. That is, in the present embodiment, the flange body 3 is provided with eight suturing holes 20. The suturing holes 20 have the same shape, and are provided in the portion between the string passing hole 10 of the flange body 3 and the mounting portion 2, respectively.

The four suturing holes 20 provided in the left side portion 3a of the flange body 3 are arranged such that two of the suturing holes 20 are paired and are vertically arranged side by side, and the other two suturing holes 20 are arranged. Similarly, the two pairs of suturing holes 20 are arranged side by side with a space therebetween in the vertical direction, and these two pairs of suturing holes 20 are arranged with a space in the lateral direction. Similarly, the four suturing holes 20 provided in the right side portion 3b of the flange body 3 are also arranged such that two of the suturing holes 20 are paired and are vertically spaced apart from each other. Similarly, the holes 20 form a pair and are arranged side by side with an interval vertically, and these two pairs of suture holes 20 are arranged side by side with an interval left and right. In both of the left side portion 3a and the right side portion 3b, the distance between the upper outer peripheral edge 30 of the flange main body 3 of the two stitching holes 20 arranged on the upper side and the two stitching holes 20 arranged on the lower side of The distance from the outer peripheral edge 30 on the lower side of the flange body 3 is the same.

The surface of the flange body 3 is integrally provided with a reinforcing portion 21 for reinforcing the opening portion of the suturing hole 20. As can be seen from FIG. 4, the reinforcing portion 21 is formed in a cylindrical shape protruding from the surface of the flange body 3, and the inner portion thereof is a hole that is continuous with the opening of the suture hole 20. By providing such a reinforcing portion 21, it is possible to increase the plate thickness in the opening portion of the suturing hole 20 of the flange main body 3 and increase the strength of the suturing hole 20 with respect to the suture thread.

As shown in FIG. 4, the suturing hole 20 can be formed in a tapered shape in which the diameter gradually increases from the front surface to the back surface of the flange body 3. In the illustrated case, the suturing hole 20 is formed in a linear taper shape (conical conical surface shape) in which the diameter is expanded at a constant rate, but is formed in a curved taper shape in which the diameter expansion rate is gradually changed. You can also do it.

The suture hole 20 is formed in a taper shape in which the diameter gradually increases from the front surface to the back surface of the flange main body 3 so that the suture thread is sutured using a suture needle (not shown) having a curved needle tip. When performing the suturing operation through the suture 20, the needle tip of the suturing needle inserted into the suturing hole 20 from the surface side is not easily pierced into the inner surface of the suturing hole 20, and the suturing operation can be facilitated.

Note that, in the case shown in FIG. 4, only the suturing hole 20 is tapered and the inner surface of the reinforcing portion 21 is formed to have a constant inner diameter. However, the inner surface of the reinforcing portion 21 is also tapered with the suturing hole 20. It is also possible to adopt a configuration in which it is formed in a taper shape that is integrally connected to the inner surface of the. Further, the suturing hole 20 is not limited to the tapered shape, and may have a shape having a constant inner diameter.

As shown in FIG. 2, the outer peripheral edge 30 of the flange body 3 is provided with a suture thread retaining recess 31. The suture thread locking recess 31 is formed in a notch shape in which the outer peripheral edge 30 of the flange body 3 is cut inward, and when the flange body 3 is directly sutured and fixed to a human body with a suture thread, The suture thread passed through the suture hole 20 can be hung over the suture thread retaining recess 31. Then, the suture thread is sewn between the suture hole 20 and the suture thread locking recess 31 to prevent the suture thread from moving along the outer peripheral edge 30 after the suture, and The suture thread can surely be sutured and fixed to the human body.

In this embodiment, four suture thread locking recesses 31 are provided in each of the left side portion 3a and the right side portion 3b of the flange body 3. That is, in this embodiment, the flange main body 3 is provided with eight suture thread locking recesses 31 as many as the suturing holes 20. In this case, two suture locking recesses 31 are provided respectively on the outer peripheral edges 30 of the left side portion 3a and the right side portion 3b of the flange main body 3 which face upward, and the lower side of the left side portion 3a and the right side portion 3b of the flange main body 3 are provided. Two suture thread locking recesses 31 are provided on the outer peripheral edge 30 facing each other. In addition, these suture thread locking recesses 31 have the same shape.

As described above, the suture thread retaining recesses 31 are provided in the same number as the suture holes 20, and each suture thread retaining recess 31 is used as a pair with the corresponding suture hole 20. It is preferable that the suture thread retaining recess 31 is provided at a portion of the outer peripheral edge 30 of the flange body 3 that is closest to the pair of suturing holes 20. For example, the suture thread locking recess 31 corresponding to the suturing hole 20 on the leftmost side and the upper side in FIG. 2 passes through the outer peripheral edge 30 of the flange main body 3 facing upward and the axial center of the suturing hole 20. It is provided at a site orthogonal to the virtual straight line. In this manner, the same number of the suture thread locking recesses 31 and the suture holes 20 are provided, and these are used as a pair, thereby narrowing the distance between the suture thread locking recesses 31 and the suturing hole 20. It is possible to reduce the looseness of the suture thread that is stretched between the suture thread retaining recess 31 and the suture hole 20.

As shown in FIG. 5, the suture thread locking recess 31 is formed in a substantially V shape having a pair of inner wall portions 31a whose width gradually narrows from the outer peripheral edge 30 of the flange body 3 toward the suturing hole 20. Is preferred. With such a shape, the opening of the suture thread locking recess 31 is enlarged to facilitate the work of hanging the suture thread passed through the suture hole 20 into the suture thread locking recess 31. It is possible to reliably prevent the movement of the suture in the direction along the outer peripheral edge 30.

The bottom wall portion 31b of the suture thread retaining recess 31 is preferably formed in a curved shape such as a semicircle. By forming the bottom wall portion 31b of the suture thread retaining recess 31 into a curved shape, the strength against the shearing force of the bottom wall portion 31b is increased as compared with the case where the suture thread retaining recess 31 is formed into an acute V shape. Thus, it is possible to prevent the flange main body 3 from being cut from the bottom wall portion 31b of the suture thread locking recess 31 by the suture thread hooked in the suture thread locking recess 31.

Note that the recess 31 for locking the suture thread is not limited to the above-described shape, and may be a rectangular shape or a U shape as long as the suture thread can be hooked to lock the movement of the suture thread along the outer peripheral edge 30. It can also be formed in other shapes such as a letter shape.

Further, in the present embodiment, four stitching holes 20 and four suture thread locking recesses 31 are provided in the left side portion 3a and the right side portion 3b of the flange body 3, respectively, but at least one suture is sutured. It suffices that the working hole 20 and at least one suture locking recess 31 are provided. Even when a plurality of suturing holes 20 and a plurality of suture thread locking recesses 31 are provided in the flange body 3, the number of them is not limited to the same number, and for example, the left side portion 3a and the right side portion 3b of the flange body 3 are vertically arranged. One suturing hole 20 is provided at the center position in the direction, and a pair of suture thread locking recesses 31 corresponding to the suturing hole 20 are provided on the upper outer peripheral edge 30 and the lower outer peripheral edge 30 of the flange body 3. The number of the arrangements and the installation positions can be variously changed, such as the configuration provided respectively.

As the constituent material of the flange member 1, for example, silicone, polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly-(4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile-butadiene-styrene copolymer Various resins such as a combination, a polyester such as polyethylene terephthalate, a butadiene-styrene copolymer, and a polyamide (for example, nylon 6, nylon 6.6, nylon 6/10, nylon 12) can be used. Among them, it is preferable to use a resin such as polyvinyl chloride, polypropylene, or a cyclic polyolefin in that molding is easy.

As shown in FIG. 6, the flange member 1 can form a fixing flange set 41 together with the fixing string member 40. The flange member 1 can be fixed to a human body by passing the fixing cord-shaped member 40 through a pair of cord passing holes 10 provided at both ends of the flange body 3 and winding the fixing cord-shaped member 40 around the neck. it can. In this case, it is preferable to use a cord formed in a flat band shape as the fixing cord-shaped member.

As the fixing string-like member 40, as long as it can be passed through the string passing hole 10 of the flange body 3 and can be wound around the neck, a braid, a non-woven fabric, or the like formed by knitting fibers such as threads, Various structures such as a string or belt formed of a resin material or a band member provided with a mechanism capable of adjusting the length can be used. Further, the fixing string-shaped member 40 is not limited to a flat band-shaped member, and various shapes such as a circular cross-section can be used.

When the flange member 1 is fixed to the human body by using the fixing string-like member 40, first, the vertical width of the string passing hole 10 of the flange body 3 is wide as shown by a chain double-dashed line in FIG. A strip-shaped fixing cord-shaped member 40 is passed through the main opening 11. At this time, since the main opening 11 is formed to have a larger vertical width than other portions, the work of inserting the fixing cord-like member 40 is easy.

Next, when the fixing cord-shaped member 40 passed through the main opening 11 is wrapped around the patient's neck and bound so that the flange member 1 has a length that does not move, the tension causes the fixing cord-shaped member 40 to bind. Reference numeral 40 moves from the main opening 11 to the narrow opening 12 through the connecting opening 13 and is put into the narrow opening 12 as shown by the solid line in FIG. 7A. At this time, since the connecting opening 13 is formed in a tapered shape, the strip-shaped fixing cord-shaped member 40 passed through the main opening 11 can be easily moved from the main opening 11 to the connecting opening 13. In addition, the width can be gradually narrowed by the connection opening 13 and easily moved to the inside of the narrow opening 12.

Since the vertical width of the narrow opening 12 is narrower than that of the main opening 11, the fixing cord-shaped member 40 passed through the narrow opening 12 is rolled into the narrow opening 12. Is arranged in the vertical direction, and movement in the vertical direction is suppressed. By suppressing the vertical movement of the fixing cord-shaped member 40 passed through the string passing hole 10 along the string passing hole 10 in this manner, the flange member 1 is attached to the human body by the fixing cord-shaped member 40. The tracheostomy tube 101 mounted on the flange member 1 can be securely held and securely held at a predetermined position.

In the present embodiment, since the string passage hole 10 is configured to include a plurality of narrow width openings 12 arranged in the vertical direction, the thickness of the neck of the patient and the proximal end of the tube body 102 in the state of being placed in the trachea. Depending on the position and the like, the position where the fixing cord-shaped member 40 is inserted into the flange member 1, that is, the connecting position of the fixing cord-shaped member 40 to the flange member 1 can be changed or adjusted up and down. As a result, the fixing string-like member 40 can be connected to the flange body 3 at a more appropriate position, and the flange member 1 or the tracheostomy tube 101 can be more reliably fixed at a predetermined position.

In particular, when the narrow opening 12 is arranged above the upper end of the main opening 11 and below the lower end thereof as in the present embodiment, the fixing string for the flange member 1 is fixed. The adjustment width in the vertical direction of the connecting position of the strip-shaped member 40 can be increased. Therefore, the flange member 1 or the tracheostomy tube 101 can be more reliably fixed to a predetermined position.

The vertical width of the connecting portion of the connecting opening portion 13 with the narrow opening portion 12 is narrower than the vertical width of the narrow opening portion 12, so that the fixing cord-shaped member 40 passed through the narrow opening portion 12 is The separation from the narrow opening 12 toward the main opening 11 side is suppressed. In particular, in this embodiment, since the return piece 14 is provided at the connecting portion, the return piece 14 ensures the movement of the fixing cord-like member 40 from the narrow opening 12 toward the main opening 11. It is possible to reliably suppress the detachment of the fixing cord-shaped member 40 from the narrow opening portion 12 by restricting to the above. Thus, the fixing string member 40 can be reliably held in the narrow opening 12 for a long period of time, and the flange member 1 or the tracheostomy tube 101 can be stably fixed at a predetermined position for a long period of time. ..

In the flange member 1, for example, when the fixing string member 40 has a thickness or a width that does not fit inside the narrow opening 12, as shown in FIG. It is also possible to suppress the vertical movement within the string passing hole 10 by hooking the passed fixing string-shaped member 40 on the pair of adjacent narrow-width openings 12 and connecting openings 13. In this case, the strip-shaped fixing cord-shaped member 40 engages with the one narrow opening 12 and the connecting opening 13 on one side thereof, and the other narrow opening 12 and the connecting opening 13 on the other side thereof. By engaging with the opening 13, vertical movement is restricted. Further, since the inner surfaces 13a of the adjacent connecting openings 13 are connected to each other at an acute angle, the acute triangular portions between the adjacent connecting openings 13 are engaged with the fixing cord-like member 40 so that the fixing cord-shaped member 40 is also formed. The movement of the member 40 in the vertical direction is restricted. With this locking method as well, as in the case shown in FIG. 7A, the vertical movement of the fixing string-shaped member 40 passed through the string passing hole 10 is suppressed, and the flange member 1 or The tracheostomy tube 101 can be reliably fixed at a predetermined position.

As shown in FIG. 8, the flange member 1 can be fixed to the human body of a patient by suturing using a suture thread 50. For example, it is preferable to use a method of directly suturing the flange member 1 to the skin by using the suture thread 50 and fixing it to the human body for a patient having a narrow neck or a patient in which the tracheostomy tube 101 is easily removed.

The suturing using the suture thread 50 is performed using, for example, a suture needle (not shown) whose tip is bent. In this case, the suture needle to which the suture thread 50 is connected is pierced from the surface side of the flange body 3 through the suture hole 20 into the skin, and the suture thread 50 is sewn to the skin. The suture thread passed through the skin is hooked in the suture thread locking recess 31 and is sewn to the skin again through the same suturing hole 20 with a suture needle.

At this time, the suture thread locking recess 31 is further formed in a substantially V-shape whose width gradually narrows from the outer peripheral edge 30 of the flange body 3 toward the suturing hole 20, so that the opening is large, It is possible to reliably prevent the suture 50 from moving in the direction along the outer peripheral edge 30 while facilitating the work of passing the suture 50 through the suture hole 20.

By repeating such a suturing operation a plurality of times, the suture thread 50 is wound between the suture hole 20 and the suture thread locking recess 31, and the flange member 1 is cut by the suture thread 50 into the skin. Sutured to. The suture thread 50 is preferably double or triple wound between the suture hole 20 and the suture locking recess 31, but the number of windings is arbitrary.

Thus, the flange member 1 can be fixed to the human body of the patient by performing the suturing using the suture thread 50 between the suturing hole 20 provided in the flange body 3 and the suture thread locking recess 31. it can.

Further, the suture thread 50 passed through the suture hole 20 is hooked in the suture thread locking recess 31 provided on the outer peripheral edge 30 of the flange body 3 to connect the suture hole 20 and the suture thread locking recess 31. Since it is wound in between, the movement of the suture thread 50 along the outer peripheral edge 30 of the flange body 3 after suturing is restricted. Therefore, even if a force is applied to the flange member 1 after the suturing, the suture thread 50 is prevented from moving along the outer peripheral edge 30 of the flange body 3, and the flange member 1 or the tracheostomy tube 101 is securely placed at a predetermined position. Can be fixed to.

Further, since the bottom wall portion 31b of the suture thread retaining recess 31 is formed in a curved shape such as a semicircle, the suture thread 50 hung on the suture thread retaining recess 31 causes the bottom wall portion 31b to be flanged. It is possible to prevent the main body 3 from being cut.

Further, since the reinforcing portion 21 is provided at the opening of the suturing hole 20, the inner surface of the suturing hole 20 from the suture thread 50 passed through the suturing hole 20 by applying force to the flange member 1 after suturing. Even if a shear load is applied to, the flange body 3 is effectively prevented from being cut.

In the present embodiment, the suturing holes 20 and the suture thread retaining recesses 31 are provided in the same number, and the suture thread retaining recesses 31 respectively corresponding to the suturing holes 20 are formed as a pair with the outer peripheral edge 30 of the flange body 3. The length of the suture thread 50 stretched between the suture hole 20 and the suture thread locking recess 31 can be further shortened because the suture thread 20 is provided at a position closest to the suture hole 20. .. As a result, the loosening of the suture thread 50 that is stretched between the suture hole 20 and the suture thread locking recess 31 is reduced, and the flange member 1 or the tracheostomy tube 101 is reliably fixed at a predetermined position. You can

In the present embodiment, since two pairs of suturing holes 20 having different lateral distances with respect to the mounting portion 2 are provided, suturing is performed according to the thickness of the patient's neck and the burden on the skin due to suturing. The suturing place using the thread 50 can be selected from two places in the left-right direction. As a result, the flange member 1 can be reliably fixed to the human body with the suture thread 50 regardless of the thickness of the neck of the patient, and the suture location is changed according to the skin burden (skin roughening, ulcer) due to the suture. Therefore, the burden on the skin can be reduced.

The fixing of the flange member 1 by suturing is not limited to the suturing thread 50 spanning between the suturing hole 20 and the suture thread locking recess 31, and the suturing thread is provided in the narrow opening 12 of the string passing hole 10. It can also be done through 50. In this case, a suture thread locking recess having the same shape as the suture thread locking recess 31 is provided at a portion of the outer peripheral edge 30 of the flange body 3 that is closest to the narrow opening 12, and the narrow opening is formed. It is also possible to hang suture thread 50 between 12 and the recess for suture thread locking so as to perform suturing.

In the tracheostomy tube 101 mounted on the flange member 1, the tube body 102, the cuff 103, and the like may have the configurations described below.

As shown in FIGS. 9 to 12, etc., the tube main body 102 extends from the tip 105 in the extending direction of the central axis O1 of the inner peripheral surface of the tube main body 102 (hereinafter, simply referred to as “central axial direction A”). The hollow portion 107 that penetrates to the base end 106 is partitioned, and in the state where the tracheostomy tube 101 is inserted from the outside into the trachea and left indwelling, the hollow portion 107 secures an airway. The tip 105 of the tube body 102 is the distal end of the tube body 102, and is one end located on the side of the tracheal branch when the tracheostomy tube 101 is left in the trachea. The proximal end 106 is the proximal end of the tube body 102, and is the other end located on the jaw side when the tracheostomy tube 101 is placed in the trachea.

More specifically, the tube body 102 includes a distal end portion 108 including a distal end 105 and a cuff attachment portion 109 that is continuous with the proximal end 106 side of the distal end portion 108 in the central axis direction A and that has the cuff 103 mounted on the outer peripheral surface. The cuff mounting portion 109 includes a curved portion 110 that is continuous on the proximal end 106 side, and a proximal portion 111 that is continuous on the proximal end 106 side of the curved portion 110 and that includes the proximal end 106. In other words, the tip end portion 108 of the tube body 102 is connected to the base end portion 111 via the cuff attachment portion 109 and the bending portion 110. The flange member 1 is attached to the base end portion 111.

Here, in the tracheostomy tube 101, when the tube body 102 is viewed from the distal end 105 side of the distal end portion 108 (see FIG. 10( b )), the proximal end 106 is in the direction toward the distal end 105, that is, the distal end. The direction in which the bending portion 110 is bent with respect to 105 is “upper side”, and the opposite side is “lower side”.

Further, as shown in FIG. 9 to FIG. 15 and the like, in the wall of the tube main body 102 between the outer peripheral surface of the tube main body 102 and the inner peripheral surface defining the hollow portion 107 of the tube main body 102, the central axis O1 is formed. Three hollow portions extending along the are defined. Specifically, the tube body 102 is formed in the wall, and extends from the first to third base end openings 112a to 114a defined in the base end face along the central axis O1 to the first to third lumens 112 to. 114 are provided. Note that the small-diameter first to third lumens 112 to 114 partitioned in the wall are also hollow portions, but here, for convenience of description, in order to distinguish from the large-diameter hollow portion 107 for securing the airway, here, Described as "lumen".

The first lumen 112 extends from the first proximal end opening 112a of the proximal end surface to a predetermined position on the proximal end 111 side of the cuff 103 and the cuff mounting portion 109, and is formed at the predetermined position. It communicates with the outside of the tube body 102 through a first suction port portion 112b that penetrates to the outer peripheral surface of the tube body 102. The first suction port portion 112b of the tracheostomy tube 101 is a suction port, and is formed in the curved portion 110 at a position closer to the proximal end portion 111 side than the cuff 103 and the cuff mounting portion 109. More specifically, the first suction port portion 112b of the tracheostomy tube 101 is formed in the end portion of the bending portion 110 on the tip end portion 108 side, that is, in the vicinity of the base end portion 111 side of the cuff attachment portion 109. There is. The first lumen 112 is a lumen for sucking and removing foreign matter X such as sputum, saliva, and blood accumulated on the upstream side (jaw side) of the trachea from the cuff 103 in the state of being placed in the trachea. Hereinafter, it is referred to as "first suction lumen".

The second lumen 113 extends from the second proximal end opening 113a of the proximal end surface to a predetermined position closer to the distal end portion 108 side than the cuff 103 and the cuff mounting portion 109, and a tube formed at the predetermined position. It communicates with the hollow portion 107 of the tube body 102 through a second suction port portion 113b that penetrates to the inner peripheral surface of the body 102. The second suction port portion 113b of the tracheostomy tube 101 is formed at the tip portion 108 at a position closer to the tip portion 108 side than the cuff 103 and the cuff mounting portion 109. More specifically, the second suction port portion 113b of the tracheostomy tube 101 is a notch-shaped suction port that continues to the position of the tip 105 on the inner peripheral surface of the tip portion 108, as shown in FIG. The second lumen 113 is a lumen for sucking and removing the foreign matter X such as sputum stored near the distal end portion 108 on the trachea downstream side (tracheal branch portion side) of the cuff 103 left in the trachea. And is hereinafter referred to as “second suction lumen”.

The third lumen 114 extends from the third base end opening 114a of the base end surface to the position of the cuff 103 and the cuff mounting portion 109, and penetrates to the outer peripheral surface of the tube body 102 formed at that position. It communicates with the outside through 114b. Therefore, for example, by using a syringe or the like, air or the like is introduced into the annular space Y defined by the outer peripheral surface of the cuff mounting portion 109 and the inner surface of the cuff 103 from the third proximal end opening 114a of the third lumen 114 through the flow path 114b. By supplying this fluid, the cuff 103 can be expanded in the radial direction B (see FIG. 15) by the supplied fluid. For the cuff 103 in the expanded state, if the fluid is sucked from the annular space Y through the flow passage 114b of the third lumen 114 and the third proximal end opening 114a, the cuff 103 is contracted in the radial direction B. Can be made. As described above, the third lumen 114 is a lumen used for contracting and expanding the cuff 103, and is hereinafter referred to as a “cuff lumen”.

Examples of the constituent material of the tube body 102 include silicone, polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly-(4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile-butadiene-styrene copolymer. Various resins such as a combination, a polyester such as polyethylene terephthalate, a butadiene-styrene copolymer, and a polyamide (for example, nylon 6, nylon 6.6, nylon 6/10, nylon 12) can be used. Among them, it is preferable to use resins such as polyvinyl chloride, polypropylene, cyclic polyolefin, polyester, and poly-(4-methylpentene-1), because they are easily molded.

The cuff 103 is mounted on the outer peripheral surface of the cuff mounting portion 109 of the tube body 102 as shown in FIGS. 8 and 15, and the outer peripheral surface of the cuff mounting portion 109 is passed through the cuff lumen 114 of the tube body 102 described above. It can be expanded by the pressure of the fluid supplied to the annular space Y defined by the inner surface of the cuff 103. Therefore, when the tracheostomy tube 101 is inserted from the outside into the trachea and the tracheostomy tube 101 is to be placed at a predetermined position, the fluid is supplied to the annular space Y through the cuff lumen 114 of the tube body 102. Then, the cuff 103 is expanded in the radial direction B (see FIG. 15) of the tube body 102. As a result, the outer surface of the expanded cuff 103 comes into close contact with the inner wall of the trachea, and the cuff 103 is sandwiched by the inner peripheral surface of the trachea due to the frictional force between the outer surface of the cuff 103 and the inner wall of the trachea. The inside of the trachea is blocked. Therefore, the position of the cuff 103 in the trachea is fixed, and the tracheostomy tube 101 can be left at the predetermined position described above.

Further, when removing the tracheostomy tube 101 from the inside of the trachea, or when re-adjusting the position of placing the tracheostomy tube 101, the fluid in the annular space Y is sucked using the cuff lumen 114, Cuff 103 is deflated. Thereby, the tube body 102 of the tracheostomy tube 101 can be moved in the trachea along the trachea.

In such a cuff 103, the end edge portion 115 on the base end 106 side and the end edge portion 116 on the tip end 105 side in the central axis direction A are in the circumferential direction C of the tube body 102 (see FIG. 9, FIG. 13, etc.). The entire area is adhered to the outer peripheral surface of the cuff attachment portion 109 by welding, ultrasonic adhesion, or the like. Thereby, the above-mentioned annular space Y is defined by the inner surface of the cuff 103 and the outer peripheral surface of the cuff mounting portion 109. More specifically, as shown in FIG. 15, the end edge portion 115 on the base end 106 side is bent inside the annular space Y, and a surface of the end edge portion 115 extending from the outer surface of the cuff 103 is formed. In the annular space Y, it is bonded to the outer peripheral surface of the cuff mounting portion 109. Further, the end edge portion 116 on the side of the tip 105 is bent to the outside of the annular space Y, and the surface of the end edge portion 116 extending from the inner surface of the cuff 103 is outside the annular space Y and the cuff mounting portion 109. Is bonded to the outer peripheral surface of the.

The constituent material of the cuff 103 may be, for example, soft polyvinyl chloride, polyurethane, polyethylene, polypropylene, polyester, ethylene-vinyl acetate copolymer (EVA), silicone, or a mixture of any of these materials. A flexible material can be used.

As shown in FIG. 16, the mounting portion 2 of the flange member 1 has the first suction lumen 112, the second suction lumen 113, and the cuff lumen 114, which are located on the base end side of the flange body 3 as described above. Alternatively, the communication holes 117a, 117b, and 117c that communicate with each other may be partitioned and formed. Note that, in FIG. 16, for convenience of description, the flange main body 3 is shown in a simplified shape by omitting the description of the string passing hole 10, the suturing hole 20, and the like, and the first suction lumen 112 of the tube main body 102, 2 The positions of the suction lumen 113 and the cuff lumen 114 are indicated by a chain double-dashed line. In this example, the first suction lumen 112, the second suction lumen 113, and the second suction lumen 113 when the proximal end portion 111 of the tube body 102 is fitted into the inside of the mounting portion 2 of the flange member 1 by fitting. The cuff lumen 114 communicates with the outside of the tracheostomy tube 101 via the corresponding communication holes 117a, 117b, 117c, and a medical tube may be connected to each of the communication holes 117a to 117c. it can.

In the example shown in FIG. 16, more specifically, the first suction lumen 112 is provided on the proximal side of the tracheostomy tube 101 through the corresponding communication hole 117a formed in the mounting portion 2 and is outside the tracheostomy tube 101. It is in communication with people. Therefore, if a syringe or a suction pump is connected to the other end of the suction tube 119, one end of which is fitted into the communication hole 117a of the mounting portion 2 exposed to the outside of the body, and suction is performed, the first suction lumen from the outside of the body. Foreign matter X such as sputum can be sucked through 112. The second suction lumen 113 is also similar to the first suction lumen 112, and the foreign matter X is absorbed through the suction tube 120, the corresponding communication hole 117b formed in the mounting portion 2 and the second suction lumen 113. Can be aspirated.

Further, the cuff lumen 114 communicates with the outside of the tracheostomy tube 101 on the proximal end side of the tracheostomy tube 101 through the corresponding communication hole 117c formed in the mounting portion 2. Therefore, if a syringe or the like is connected to the other end of the cuff tube 121, one end of which is fitted into the communication hole 117c of the mounting portion 2 exposed outside the body, the annular space of the cuff 103 can be operated by operating the syringe or the like outside the body. A fluid can be supplied to Y and suction can be performed, whereby the expansion and contraction of the cuff 103 can be manipulated.

The mounting portion 2 of the flange member 1 is mounted concentrically with the base end portion 111 of the tube body 102, the position of the first suction lumen 112 in the circumferential direction C of the tube body 102, and the second suction lumen 113. The position and the position of the cuff lumen 114 are near the positions of the corresponding communicating holes 117a, 117b, and 117c of the mounting portion 2 in the circumferential direction C. Therefore, the communication holes 117a, 117b, 117c can be shortened, and the complication of the structure of the communication holes 117a, 117b, 117c of the mounting portion 2 can be suppressed. Further, as shown in FIG. 16, the suction tubes 119 and 120 and the cuff tube 121 are arranged in a direction in which the flange main body 3 is projected from the communication holes 117a, 117b, 117c in the plan view of FIG. It is connected so as to extend and does not extend to the side of the tip portion 108. By connecting in this manner, the suction tubes 119 and 120 and the cuff tube 121 are prevented from hitting the patient's jaw in the state where the tracheostomy tube 101 is left in the trachea, and the tracheostomy tube 101 is prevented. It is possible to reduce the discomfort of the patient who is indwelled.

Hereinafter, the details of the tube body 102 in the tracheostomy tube 101 will be further described.

[Tip part 108 of tube body 102]
As shown in FIG. 13, in the tube body 102, the central axis O2 of the outer peripheral surface is different from the central axis O1 of the inner peripheral surface that defines the hollow portion 107. Specifically, in a cross section (excluding one cross section including the tip end surface of the tube body 102) orthogonal to the central axis O1 of the inner peripheral surface as shown in FIG. 13, the central axis O1 of the inner peripheral surface is It is located above the central axis O2, and as shown in FIG. 13, the outer peripheral surface and the inner peripheral surface are not concentric circles in the same cross section. More specifically, as shown in FIG. 13, the outer peripheral surface of the tube main body 102 is positioned on the outer curved surface side (lower side in FIG. 13) of the bending portion 110 in the cross section orthogonal to the central axis O1 of the inner peripheral surface. A lower surface portion 122, an upper surface portion 123 located on the inner curved surface side (upper side in FIG. 13) of the bending portion 110, and a side surface portion 124 connecting the lower surface portion 122 and the upper surface portion 123 in the circumferential direction C of the tube body 102. In the same cross section (the same cross section that does not include the portion on the upper surface 123 side of the tapered shape portion 125 described later), the thickness T of the tube main body 102 is closer to the lower surface 122 side than to the upper surface 123 side. thick. Further, in the same cross section, the thickness T of the tube main body 102 is configured to gradually increase in the circumferential direction C from the upper surface portion 123 toward the lower surface portion 122 (see FIG. 13 ). The "thickness T of the tube body 102" means the wall thickness of the tube body 102 on a line segment connecting the central axis O1 and one point on the outer peripheral surface.

By making the thickness T on the lower surface 122 side of the tube body 102 thicker than the thickness T on the upper surface 123 side, the first and second suction lumens 112 and 113 formed in the wall on the lower surface 122 side are formed. The cross-sectional area can be made relatively large, clogging of the foreign matter X in the first and second suction lumens 112 and 113 can be suppressed, the suction pressure required for suction can be reduced, and suction efficiency can be improved. Can be improved.

Here, as shown in FIGS. 9 to 15 and the like, on the outer peripheral surface of the tip end portion 108 of the tube main body 102, a taper-shaped portion 125 having an outer diameter gradually decreasing toward the tip end 105 and extending to the tip end 105 is formed. ing. The tapered portion 125 can reduce insertion resistance when the tube body 102 is inserted from the outside of the body into the trachea. In particular, as described above, by providing the tapered portion 125 on the outer peripheral surface of the distal end portion 108 of the tube body 102 having a different thickness T (see FIG. 13) depending on the position in the circumferential direction C, the tube body 102 is moved from outside the body to the trachea. It is possible to suppress an increase in insertion resistance that may occur in a portion having a large thickness T when inserting. When the tube body 102 is inserted into the trachea from outside the body, for example, the skin of the throat and the trachea are incised to form an insertion opening, and the insertion opening is enlarged by using an obturator 150 or the like described later, Insert 102. The obturator 150 is withdrawn from the proximal end 106 side of the tube body 102 after the cuff 103 is expanded and the tube body 102 is left at a predetermined position in the trachea. Further, the obturator 150 may leave the tube body 102 at a predetermined position in the trachea and remove it from the proximal end 106 side of the tube body 102 before expanding the cuff 103.

Further, as shown in FIG. 15, the angle θ1 of the tapered portion 125 with respect to the central axis O1 of the inner peripheral surface of the tube body 102 is substantially the same regardless of the position in the circumferential direction C. As a result, when inserting the tube body 102 into the trachea from outside the body, it is possible to reduce the insertion resistance difference in the circumferential direction C that may occur due to the difference in the angle with respect to the central axis O1 depending on the position in the circumferential direction C.

Further, the tapered portion 125 has a truncated cone shape in which the length of the lower surface portion 122 in the central axis direction A is longer than the length of the upper surface portion 123 in the central axis direction A. Specifically, as described above, the angle θ1 of the tapered portion 125 with respect to the central axis O1 of the inner peripheral surface of the tube body 102 is substantially the same regardless of the position in the circumferential direction C (see FIG. 15 ). As shown in FIG. 10(a), an ellipse formed by connecting the base ends of the outer peripheral surface of the tapered shape portion 125 in the central axis direction A in the circumferential direction C (as indicated by the solid line indicated by “M” in FIG. 10(a)). A circle formed by connecting a cross-section including the formed ellipse) and the tip of the outer peripheral surface of the tapered portion 125 (the same as the tip of the outer peripheral surface of the tube body 102) in the circumferential direction C (in FIG. 10A). It is not parallel to the cross section including the circle formed by the solid line indicated by "N". That is, as shown in FIG. 15, the angle θ1 of the tapered portion 125 with respect to the central axis O1 in the lower surface portion 122 and the upper surface portion 123 is the same, but the taper in the central axis direction A in the lower surface portion 122 and the upper surface portion 123. The shapes 125 have different lengths.

Then, by making the length of the lower surface portion 122 in the central axis direction A longer than the length of the upper surface portion 123 in the central axis direction A, the tube on the lower surface portion 122 side in the portion other than the tapered portion 125. Although the thickness T of the main body 102 (see FIG. 13) is thicker than the thickness T of the tube body 102 on the upper surface 123 side, the thickness T on the lower surface 122 side and the upper surface 123 side on the distal end surface of the tube main body 102 side. The thickness difference (difference in thickness T) with the thickness T can be made small, or the thickness T of both can be made substantially equal. That is, since the difference in wall thickness depending on the position in the circumferential direction C can be reduced on the distal end surface of the tube body 102, uneven deformation of the tube body 102 due to the difference in rigidity in the circumferential direction C and this unevenness. It is possible to suppress an increase in insertion resistance due to a large deformation.

In particular, the thickness T of the tube main body 102 at the tip end surface is made uniform regardless of the position in the circumferential direction C, and the center axis O1 of the inner peripheral surface and the center axis O2 of the outer peripheral surface are substantially coincident with each other at the tip end surface of the tube main body 102. It is preferable to have a concentric configuration (see FIG. 15). In the case of such a configuration, it is particularly preferable to make the thickness T uniform at the tip end surface in order to reduce the insertion resistance at the tip end surface. In the illustrated case, the thickness T of the tip surface of the tube body 102 is set to 0.6 mm regardless of the position in the circumferential direction C.

[First and Second Suction Lumens 112 and 113 of Tube Body 102] Next, the positional relationship between the first suction lumen 112 (first lumen 112) and the second suction lumen 113 (second lumen 113) Will be described in detail.

As shown in FIGS. 9 to 15, the first suction lumen 112 extends inside the wall of the tube body 102 along the central axis O1 of the inner peripheral surface of the tube body 102, and the first suction lumen 112 The lumen for use 112 is located closer to the base end 111 than the cuff 103 and the cuff mounting portion 109 is, and the outer wall is formed on the outer peripheral surface of the tube body 102 through the inner wall opening 126 formed in the inner wall of the first suction lumen 112. It communicates with the outside through a suction port serving as a first suction port 112b penetrating to the opening 127.

Further, the second suction lumen 113 is provided in the wall of the tube main body 102 along the central axis O1 of the inner peripheral surface of the tube main body 102 from the base end portion 111 closer to the base end portion 111 than the cuff 103 to the cuff 103. It extends to the tip end portion 108 closer to the tip end portion 108 side. As described above, the second suction lumen 113 communicates with the inner hollow portion 107 of the tube body 102 through the suction port as the second suction port portion 113b that penetrates to the inner peripheral surface of the tube body 102. There is.

Here, the cross section shown in FIG. 13 is a cross section that includes the first suction lumen 112, the second suction lumen 113, and the cuff lumen 114 and is orthogonal to the central axis O1. 13 indicates a first virtual plane P1 including the central axis O1 at the positions of the distal end portion 108 and the proximal end portion 111 of the tube body 102, and the first virtual plane P1 is , A plane including all of the central axis O1 of the tube body 102. Further, “P2” indicated by a broken line in FIG. 13 indicates a second virtual plane P2 that passes through the central axis O1 on the cross section of FIG. 13 and is orthogonal to the first virtual plane P1. Then, a line of intersection between the first virtual plane P1 and the lower surface portion 122 located on the outer curved surface side of the curved portion 110 (see FIG. 9 and the like) on the outer peripheral surface of the tube body 102 is a first intersecting line L1 (see FIG. 15), the point K1 shown in FIG. 13 indicates a point on the first intersection line L1. When the intersection line of the first virtual plane P1 and the upper surface portion 123 of the outer peripheral surface of the tube body 102 located on the inner curved surface side of the curved portion 110 is the second intersection line L2 (see FIG. 15 ). The point K2 shown in FIG. 13 indicates a point on the second intersection line L2. Further, a straight line L3 shown by a chain double-dashed line in FIG. 13 is an imaginary line passing through two points forming the maximum diameter of the first suction lumen 112 among the inner walls that partition the first suction lumen 112 in this cross-sectional view. In FIG. 13, a straight line L4 indicated by a chain double-dashed line in FIG. 13 is an imaginary line that passes through two points forming the maximum diameter of the second suction lumen 113 among the inner walls that partition the second suction lumen 113. A line is shown. For convenience of description, the straight line L3 will be referred to as a "first straight line L3" and the straight line L4 will be referred to as a "second straight line L4".

As shown in FIG. 13, the second suction lumen 113 is formed at a position where the first straight line L3 does not intersect, and the first suction lumen 112 is formed at a position where the second straight line L4 does not intersect. There is. With such a configuration, the distance between the first suction lumen 112 and the second suction lumen 113 in the circumferential direction C can be set to a predetermined distance or more, and the tube body 102 of the tracheostomy tube 101 is manufactured. At this time, it becomes easy to form the first suction lumen 112 and the second suction lumen 113 as separate separate lumens. Further, as shown in FIG. 17, when the outer wall opening 127 is formed on the outer peripheral surface of the tube body 102, it is possible to prevent the formed opening from communicating with the second suction lumen 113.

Further, as shown in FIG. 13, the second suction lumen 113 is provided on the lower surface 122 side of the tube body 102 and at a position intersecting with the first virtual plane P1. The lower surface 122 of the tube body 102 is a surface that is the back side when the tracheostomy tube 101 is left in the trachea, and is a vertically lower surface for a patient who is lying down. That is, by arranging the second suction lumen 113 on the lower surface 122 side, foreign matter X (such as sputum) that is likely to be stored on the inner surface (back surface) vertically downward in the trachea of the sleeping patient. 1 (see FIG. 1) can be easily sucked through the second suction lumen 113.

Further, as shown in FIG. 13, the angle θ2 formed by the first straight line L3 and the second straight line L4 is larger than 90 degrees. With such a configuration, the distance between the first suction lumen 112 and the second suction lumen 113 in the circumferential direction C can be less than the predetermined distance. As described above, in the trachea of a sleeping patient, foreign matter X such as sputum is likely to accumulate on the back surface of the trachea. Therefore, like the second suction lumen 113, the first suction lumen 112 is also preferably on the lower surface 122 side of the tube body 102. Therefore, by arranging the first suction lumen 112 and the second suction lumen 113 such that the angle θ2 formed by the first straight line L3 and the second straight line L4 in the cross-sectional view of FIG. 13 is larger than 90 degrees, The position of the first suction lumen 112 in the circumferential direction C can be set to a position close to the second suction lumen 113 arranged at a position intersecting the first virtual plane P1 on the lower surface portion 22 side.

In other words, the first suction lumen 112 is formed at a position where the central angle is less than 90 degrees from the point K1 on the first intersection line L1 with the central axis O1 as the center in the cross-sectional view of FIG. It is formed at a position that does not intersect the first virtual plane P1 and the second virtual plane P2. That is, in the cross section of FIG. 13, the first suction lumen 112 is formed on the lower surface portion 122 side of the second virtual plane P2 and at a position that does not intersect the first virtual plane P1 and the second virtual plane P2. There is.

In the cross-sectional view of FIG. 13, the center point R of the first suction lumen 112 on the first straight line L3 with the center axis O1 as the center has a center angle of 30 to 30 from the point K1 on the first intersecting line L1. The range of 80 degrees is preferable, the range of 40 to 70 degrees is more preferable, and the range of 55 to 65 degrees is particularly preferable. Further, in the cross-sectional view of FIG. 13, it is preferable that the midpoint S of the second suction lumen 113 on the second straight line L4 is located at a position intersecting with the first virtual plane P1. With respect to the central axis O1, the midpoint R of the first suction lumen 112 on the first straight line L3 has a central angle of 30 to 80 degrees from the midpoint S of the second suction lumen 113 on the second straight line L4. Is more preferable, the range of 40 to 70 degrees is more preferable, and the range of 55 to 65 degrees is particularly preferable. However, the second suction lumen 113 may be located on the lower surface 122 side, and as shown in FIG. 13, the middle point S of the second suction lumen 113 is not located on the first virtual plane P1. It may be configured.

Further, as shown in FIG. 13, in a cross section including the first suction lumen 112 and the second suction lumen 113 and orthogonal to the central axis O1, the first suction lumen 112 and the second suction lumen 113 are substantially elliptical. have. Therefore, the first straight line L3 is the long axis of the first suction lumen 112 and its extension line, and the second straight line L4 is the long axis of the second suction lumen 113 and its extension line.

In addition, as shown in FIG. 13, in the cross section that includes the first suction lumen 112, the second suction lumen 113, and the cuff lumen 114 and is orthogonal to the central axis O1, the cuff lumen 114 also has an outer circumference of the tube body 102. It is formed at a position intersecting the first virtual plane P1 on the upper surface 123 side of the surface. That is, in the cross-sectional view shown in FIG. 13, the second suction lumen 113 and the cuff lumen 114 are formed at positions substantially facing each other with the central axis O1 interposed therebetween.

[First suction port portion 112b of the first suction lumen 112]
Next, the details of the suction port as the first suction port portion 112b of the first suction lumen 112 will be described. As shown in FIGS. 9, 11A, and 12B, the first suction port portion 112b is formed on the inner wall of the first suction lumen 112 at a position closer to the base end portion 111 side than the cuff 103. It is a suction port that penetrates from the inner wall opening 126 to the outer wall opening 127 formed on the outer peripheral surface of the tube body 102.

FIG. 17 shows a cross section that is orthogonal to the central axis O1 and includes the inner wall opening 126. As shown in FIG. 17, the inner wall opening 126 passes through the central axis O1 on the cross section shown in FIG. 17 and is orthogonal to the first imaginary plane P1 similarly to the first suction lumen 112 in FIG. 13 described above. The first virtual plane P1 and the second virtual plane P2 that are on the lower surface portion 122 side of the outer peripheral surface of the tube body 102 that is located on the outer curved surface side of the curved portion 110 (see FIG. 9, etc.) with respect to the virtual plane P2. It is formed in a position that does not intersect with. Therefore, the foreign matter X such as sputum, which is easily stored on the inner surface of the trachea on the back side, can be easily sucked through the inner wall opening 126 and the first suction lumen 112.

Further, in the cross section shown in FIG. 17, the position of the midpoint W in the circumferential direction of the inner wall opening 126 is the same as the midpoint R of the first suction lumen 112 on the first straight line L3 in FIG. With respect to the central axis O1 on the cross section shown in FIG. 17, the central angle is preferably in the range of 30 to 80 degrees from the point K1 on the first intersection line L1, and more preferably in the range of 40 to 70 degrees. The range of 55 to 65 degrees is particularly preferable.

Further, when the suction port as the first suction port portion 112b is viewed from the outside of the outer peripheral surface of the tube body 102 to the front, the inner wall opening 126 has a substantially rectangular shape as shown in FIG. 11(a). The outer wall opening 127 has a substantially elliptical shape. More specifically, the inner wall opening 126 has a substantially rectangular shape, and the outer wall opening 127 has a substantially elliptical shape in which the long axis direction is not parallel to the central axis direction A and is substantially orthogonal. The shapes of the inner wall opening 126 and the outer wall opening 127 are formed by forming the suction port as the first suction port 112b into a groove formed in the outer wall of the tube body 102. Specifically, the groove forming the suction port extends linearly in a direction not parallel to the central axis O1 and not along the circumferential direction C of the tube body 102. Then, as shown in FIG. 9, the groove forming the suction port has an arc shape in which the cross section of the inner surface of the groove is uniform. The edge of the groove defines an outer wall opening 127 having a substantially elliptical shape, and a part of an arc-shaped curved surface having a uniform cross section inside the groove defines an inner wall opening 126 having a substantially quadrangular shape. In other words, the groove forming the suction port has a receiving shape of a cylindrical outer peripheral surface that imitates the outer peripheral surface of the tube body 102 against the outer peripheral surface of the tube body 102.

As described above, by forming the suction port as the first suction port portion 112b by the groove that extends linearly without extending along the circumferential direction C of the tube body 102 in a direction not parallel to the central axis O1, during suction, It is possible to prevent the inner surface of the trachea from sticking so as to close the inner wall opening 126.

FIG. 18 shows a modification of the suction port as the first suction port portion 112b. The suction port as the first suction port portion 112b shown in FIG. 11A is configured by a groove extending in a direction substantially orthogonal to the central axis O1, but the first suction port portion shown in FIG. The suction port 112b is formed by a groove extending in a direction that is not parallel to the central axis O1 and is not orthogonal to the central axis O1. By forming the suction port as the first suction port portion 112b with such a groove, the inner wall opening 126 has a substantially parallelogram shape when viewed from the outside of the outer peripheral surface of the tube body 102 to the front. Due to the influence of surface tension and the like, it is possible to make the shape easy to suck sputum, saliva and the like.

Further, in FIG. 18, a plurality of convex portions 140 are provided on the inner surface of the groove forming the suction port serving as the first suction port portion 112b, and a concavo-convex shape is formed. By forming such a concavo-convex shape on the inner surface of the groove, it is possible to further prevent the inner surface of the trachea from adhering so as to close the inner wall opening 126 during suction.

Furthermore, in FIG. 18, the suction port as the first suction port portion 112b is formed at the position of the curved portion 110 in the central axis direction A. Then, when forming the suction port as the first suction port portion 112b in the curved portion 110, it is beneficial to configure it by a groove that extends in a direction that is not parallel to the central axis O1 and is not orthogonal. That is, if the suction port as the first suction port portion 112b is configured by a groove extending in a direction that is not parallel to the central axis O1 and is not orthogonal to the central axis O1, and the groove is formed at the position of the curved portion 110, the inner wall opening is formed. 126 can be formed in a substantially parallelogram shape having a long diagonal line in the vertical direction. Therefore, the lower end position of the inner wall opening 126 can be on the lower surface 122 side as compared with the case where a groove extending in the direction orthogonal to the central axis O1 is formed at the position of the bending portion 110, and thus the tube main body. When 102 is placed in the trachea, it is possible to easily inhale sputum, saliva, etc. accumulated on the inner surface on the back side in the trachea.

As described above, the suction port serving as the first suction port portion 112b sucks the foreign matter X (see FIG. 1) such as sputum or saliva stored near the proximal end 106 side of the cuff 103 of the tracheostomy tube 101. Therefore, it is particularly preferable that the cuff 103 and the cuff mounting portion 109 be located near the base end 106 side in the central axis direction A.

[Method for manufacturing tracheostomy tube 101]
Next, a method for manufacturing the tracheostomy tube 101 will be described. FIG. 19 is a flowchart showing the procedure of the method of manufacturing the tube body 102 of the method of manufacturing the tracheostomy tube 101. As shown in FIG. 19, in the method for manufacturing the tube body 102 of the tracheostomy tube 101, the hollow portion 107 penetrating from the distal end 105 to the proximal end 106 is defined, and the first suction lumen 112 as two lumens is formed in the wall. And step S1 of extruding and molding the tube material having the second suction lumen 113, step S2 of adhering the cuff 103 to the outer peripheral surface of the extruded tube material, and forming a tapered shape at the tip of the tube material. Step S3 of pressing the mold having the formed inner surface to form a tapered portion 125 having an outer diameter gradually decreasing toward the distal end and extending to the distal end on the outer peripheral surface at the distal end of the tube material; A blade such as a feather blade is inserted through the tip opening, and a groove is formed at the position where the tip of the second suction lumen 113 is located on the inner peripheral surface at the position where the tapered portion 125 of the outer peripheral surface is formed. Step S4 and step S5 of forming the first suction port portion 112b with a tool having a circular tip at a position near the base end side from the cuff attachment portion of the tube material are included.

In step S3 of forming the tapered portion 125 described above, the end edge portion 116 of the cuff 103 on the distal end 105 side of the tube material is sandwiched between the inner surface of the mold and the outer peripheral surface of the tube material, and the cuff 103 is cut off. Melt part. As a result, the edge portion 116 of the cuff 103 is melted, and the adhesive force between the edge portion 116 of the cuff 103 and the outer peripheral surface of the cuff mounting portion 109 can be further strengthened.

In addition, the second suction port portion 113b of the second suction lumen 113 (see FIG. 14) is formed by the groove formed in step S4 of forming a groove on the inner peripheral surface that defines the tip of the second suction lumen 113. ) Is formed. In the above-described manufacturing method, the groove is formed by cutting off a part of the inner wall using a blade, but it may be a notch member capable of forming a groove by cutting out a part of the inner wall, and the above-mentioned blade It is not limited to. Further, in the manufacturing method described above, also in step S5 of forming the first suction port portion 112b, a blade having a circular tip or a blade having a U-shaped tip such as a chisel of a chisel is used. Although the groove-shaped first suction port portion 112b is formed as shown in FIG. 17 and the like, a notch capable of forming the groove-shaped first suction port portion 112b by cutting out a part of the outer wall of the tube material. It may be any member, and is not limited to the above-mentioned blade.

Note that each step of the method for manufacturing the tracheostomy tube 101 other than the method for manufacturing the tube body 102 can be realized by using various known methods, and a description thereof will be omitted here.

[Tracheostomy tube set 200]
Finally, a tracheostomy tube set 200 including the above-described tracheostomy tube 101 and an obturator 150 that is inserted into the trachea from outside the body together with the tube body 102 will be described.

FIG. 20 is a cross-sectional view of the tracheostomy tube set 200. As shown in FIG. 20, a tracheostomy tube set 200 includes a tracheostomy tube 101 including a tube body 102, and a tracheostomy tube 101 and the inside of the trachea with the tip protruding from a tip opening 128 of the tube body 102. And an obturator 150 to be inserted.

The tip of the obturator 150 is inserted into the insertion opening formed in the skin and trachea before the tip 105 of the tube body 102 of the tracheostomy tube 101. The obturator 150 widens the insertion port to facilitate insertion of the tube body 102 into the trachea.

In the tracheostomy tube 101, when the obturator 150 is inserted into the tube body 102, the obturator 150 is engaged with the obturator 150 so that the obturator 150 with respect to the tracheostomy tube 101 in the central axial direction A of the inner peripheral surface of the tube body 102. An engagement portion 129 that regulates the insertion amount is provided.

Specifically, the engaging portion 129 of the tracheostomy tube 101 shown in FIG. 20 is the base end surface of the mounting portion 2 of the flange member 1, and the obturator 150 is placed from the base end 106 (see FIG. 9) side of the tube body 102. As it is inserted into the tube body 102, the flange portion 152 provided on the base end portion 151 of the obturator 150 comes into contact with the base end surface of the mounting portion 2 of the flange member 1 on which the tracheostomy tube 101 is mounted, and the obturator No more 150 can be inserted. That is, the insertion amount of the obturator 150 into the tracheostomy tube 101 is regulated by the base end surface of the mounting portion 2 of the flange member 1 to which the tracheostomy tube 101 is mounted. The engagement portion is not limited to that shown in FIG. 20, and for example, a female screw portion is provided on the inner surface of the mounting portion 2 of the flange member 1 and a male screw portion is provided on the outer surface of the base end portion 151 of the obturator 150. The tracheostomy tube 101 and the obturator 150 may be engaged with each other by screwing the female screw portion and the male screw portion.

As described above, on the outer peripheral surface of the tip end portion 108 of the tube body 102, the tapered shape portion 125 extending to the tip end 105 is formed, the outer diameter of which gradually decreases toward the tip end 105 (see FIG. 9, etc.). .. Further, on the outer peripheral surface of the tip portion 153 of the obturator 150, a tapered portion 154 having an outer diameter gradually decreasing toward the tip is formed. Hereinafter, in order to distinguish the taper-shaped portion 125 of the tube body 102 and the taper-shaped portion 154 of the obturator 150, the taper-shaped portion 125 of the tube body 102 is referred to as a “first taper-shaped portion 125 ”, and the taper-shaped portion 125 of the obturator 150 is described. The taper-shaped portion 154 is referred to as a “second taper-shaped portion 154”.

In a state where the obturator 150 is engaged with the engagement portion 129, at least a part of the second tapered shape portion 154 is exposed outward from the tip end opening 128 of the tube body 102, and in the central axis direction A, the tube body 102. The first taper-shaped portion 125 and the second taper-shaped portion 154 of the obturator 150 are continuously positioned. With such a configuration, insertion resistance at the distal end 105 of the tube body 102 when inserting from the outside of the body into the trachea can be reduced.

Further, in FIG. 20, the angle θ1 of the first tapered shape portion 125 with respect to the central axis direction A is larger than the angle θ3 of the second tapered shape portion 154. The angle θ1 of the first tapered shape portion 125 with respect to the central axis direction A can be made smaller than the angle θ3 of the second tapered shape portion 154 or can be made substantially equal, as shown in FIG. In addition, it is more preferable to make the angle θ1 of the first tapered portion 125 larger than the angle θ3 of the second tapered portion 154 because the insertion resistance at the tip 105 of the tube body 102 can be reduced. Further, by making the angle θ1 of the first taper-shaped portion 125 substantially equal to the angle θ3 of the second taper-shaped portion 154, the tip 105 of the tube main body 102 and the obturator 150 have a substantially integrated structure, and the tip 105 has Insertion resistance can also be reduced. Further, by making the angle θ1 of the first taper-shaped portion 125 smaller than the angle θ3 of the second taper-shaped portion 154, the tip 105 of the tube body 102 and the obturator 150 are excessively inserted into the trachea inner wall. The damage of can be reduced.

Further, the tube body 102 has a tip surface including an edge portion 130 that defines the tip opening 128, and when the obturator 150 is engaged with the engaging portion 129, the outer peripheral surface of the second tapered shape portion 154 is a tube. The edge portion 130 of the body 102 is fitted and abutted. That is, the outer peripheral surface of the second tapered shape portion 154 is in contact with the edge portion 130 over the entire area in the circumferential direction C. With such a configuration, the step in the radial direction B between the first tapered shape portion 125 and the second tapered shape portion 154 is limited to the thickness T (see FIG. 13) at the distal end surface of the tube body 102. Therefore, the insertion resistance at the tip 105 of the tube body 102 is reduced as compared with the configuration in which the outer peripheral surface of the second tapered shape portion 154 is not in contact with the edge portion 130 of the tube body 102 in the entire circumferential direction C. be able to.

In the tracheostomy tube 101 described above, the tube body 102 is a straight tubular portion that does not bend the distal end portion 108, the cuff attachment portion 109, and the proximal end portion 111, but from the distal end portion to the proximal end portion. Can also be a curved tube body.

Further, as shown in FIG. 13, the midpoint S of the second suction lumen 113 on the second straight line L4 in the above-mentioned tube body 102 is not located on the first imaginary plane P1 and the side surface portion 124. If the configuration is such that the midpoint S is located on the first imaginary plane P1 in the cross-sectional view of FIG. 13 although it is displaced to the side, foreign matter X such as sputum that easily accumulates on the inner surface on the back side in the trachea Since it is easy to be sucked through the second suction lumen 113, such an arrangement is more preferable. Further, as shown in FIG. 13, in the case where the midpoint S of the second suction lumen 113 on the second straight line L4 in the above-mentioned tube body 102 is not located on the first virtual plane P1. However, as shown in FIG. 21, if the suction port as the second suction port portion 113b is formed at a position near the point K1 on the first intersection line L1, the foreign substance X can be easily sucked. It can be configured. Note that FIG. 21 shows a cross section at the same position as in FIG. 14, and in this cross-sectional view, the third suction port as the second suction port portion 113b passes through two points forming the maximum diameter of the suction port. The suction port as the second suction port portion 113b is arranged such that the midpoint U of the suction port on the straight line L5 (virtual line) is located on the first virtual plane P1.

The present invention is not limited to the configurations specified in the above-described embodiments, and various modifications can be made without departing from the scope of the invention described in the claims.

For example, in the above embodiment, the pair of string passing holes 10 are provided in the flange body 3, but the string passing holes 10 may not be provided.

INDUSTRIAL APPLICABILITY The present invention can be used when providing a flange member that is securely fixed to a human body by suturing using a suture and that can hold a tracheostomy tube at a predetermined position.

1: Flange member 2: Mounting part 3: Flange body 4: Connection body 5: Opening hole 10 for visual observation: String passing hole 11: Main opening 12: Narrow opening 13: Connecting opening 13a: Inner surface of connecting opening 14: Return piece 14a: One outer surface 14b of the return piece: The other outer surface 20 of the return piece 20: Stitching hole 21: Reinforcing part 30: Outer peripheral edge 31 of the flange body 31: Suture locking recess 31a: Inner wall 31b: Bottom wall 40: Fixing string member 41: Fixing flange set 50: Suture 101: Tracheostomy tube 102: Tube body 103: Cuff 105: Tube body tip 106: Tube body base 107: Hollow portion 108 : Tube body tip portion 109: Tube body cuff attachment portion 110: Tube body curved portion 111: Tube body base end portion 112: First suction lumen (first lumen)
112a: 1st base end opening 112b: 1st suction port part (suction port)
113: Second suction lumen (second lumen)
113a: 2nd base end opening 113b: 2nd suction port part (suction port)
114: Cuff lumen (3rd lumen)
114a: 3rd base end opening 114b: Flow path 115: Base end side edge part 116: Tip side end edge parts 117a to 117c: Communication holes 119, 120: Suction tubes (medical tubes)
121: Cuff tube (medical tube)
122: lower surface part 123: upper surface part 124: side surface part 125: first tapered shape part (tapered shape part)
126: Inner wall opening 127: Outer wall opening 128: Tip opening 129: Engaging portion 130: Edge portion 140: Convex portion 150: Obturator 151: Obturator base end portion 152: Flange portion 153: Obturator tip end portion 154: Second taper Shaped part (tapered part)
200: Tracheotomy tube set A: Direction of the central axis of the inner peripheral surface of the tube body B: Radial direction of the tube body C: Circumferential direction of the tube body K1: Point on the first intersection line K2: Point on the second intersection line L1 : First intersection line L2: Second intersection line L3: First straight line (virtual line)
L4: Second straight line (virtual line)
L5: Third straight line (virtual line)
M: A line connecting the base ends of the tapered portions in the circumferential direction N: A line connecting the tips of the tapered portions in the circumferential direction O1: A central axis line of the inner peripheral surface of the tube body O2: A central axis line P1 of the outer peripheral surface of the tube body First virtual plane P2: Second virtual plane R: Midpoint of the first suction lumen on the first straight line S: Midpoint of the second suction lumen on the second straight line T: Thickness of the tube body U: Third Midpoint X of the second suction port portion on the straight line: Foreign substance Y: Annular space W: Midpoint in the circumferential direction of the inner wall opening θ1: Angle of the tapered portion of the tube body with respect to the central axis θ2: First straight line and second straight line Angle θ3 formed by and: Angle of tapered portion of obturator with respect to central axis

Claims (9)

A flange member used with a tracheostomy tube ,
A plate-shaped flange body with a suture locking recesses in the outer periphery provided with a sewing engagement hole,
A mounting portion to which the tracheostomy tube is mounted , the flange member. The flange member according to claim 1, wherein the suturing hole and the suture thread retaining recess are provided in both left and right sides of the flange body with the mounting portion interposed therebetween. The flange member according to claim 2, wherein a pair of the suturing holes are provided side by side at upper and lower intervals on both left and right sides of the flange body with the mounting portion interposed therebetween. The flange member according to claim 2 or 3, wherein a pair of the stitching holes are provided side by side at left and right sides on both left and right sides of the flange body with the mounting portion interposed therebetween. The flange member according to any one of claims 1 to 4, wherein the suture thread locking recesses are provided in both upper and lower portions of the flange body. The flange member according to any one of claims 1 to 5, wherein the same number of the suture holes and the suture thread locking recesses are provided. The reinforcing portion which is continuous with the opening of the suturing hole and protrudes from the surface of the flange body is integrally provided on the surface of the flange body. Flange member. The flange member according to any one of claims 1 to 7, wherein the stitching hole is formed in a tapered shape in which the diameter gradually increases from the front surface to the back surface of the flange body. On both right and left sides of the flange body with the mounting portion sandwiched therebetween, string passing holes through which fixing string-like members are inserted are provided,
The string passing hole,
The main opening,
A narrow opening formed vertically narrower than the main opening, the narrow opening being provided outside the main opening;
It has a connection opening part which connects the main opening part and the narrow width opening part, and has a vertical width of a connecting portion with the narrow opening part whose vertical width is narrower than the vertical width of the narrow opening part. Item 9. The flange member according to any one of items 1 to 8.

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