Stylet for assisting intubation of tracheal tube

Abstract

To provide a stylet capable of bending the distal end of an inserted tracheal tube in an intubation manipulation.SOLUTION: The stylet comprises: a shaft inserted into a tracheal tube having a distal end opening and a proximal end opening, and used; and an actuator which is provided at the shaft and receives an actuation for changing the shape of the shaft. The shaft comprises a projection part on a distal end side projecting from the distal end opening and an inserted portion on a proximal end side positioned within the tracheal tube when the shaft is inserted into the tracheal tube from the proximal end opening. The projection part has an easily deformable part which is easier to deform than the inserted part when the actuator is actuated.SELECTED DRAWING: Figure 4

Description

[Technical Field]

[0001] The present disclosure relates to a stylet that is used as an aid in inserting a tracheal tube. [Background technology]

[0002] In medical settings, for example, during general anesthesia, emergency resuscitation, or before artificial respiration, a tracheal tube is inserted into a patient's trachea to secure the airway. A tracheal tube is a flexible tube with openings at its distal and proximal ends, with an inflatable cuff attached near the distal end. Such a tracheal tube is inserted into the patient's trachea through the patient's mouth, and the cuff is positioned deeper than the glottis and then inflated by supplying air. This allows the patient's lungs to communicate with the outside through the interior space of the flexible tube, while the airway outside the flexible tube is blocked (filled) by the cuff. In this state, the patient's breathing is managed by connecting a ventilator to the opening at the proximal end of the flexible tube.

[0003] The human glottis is located in the larynx, which connects the trachea and pharynx. The larynx is divided into a supraglottic region, which is closer to the outside, and a subglottic region, which is farther from the outside (closer to the lungs), by the glottis. The epiglottis is located in the supraglottic region. Therefore, when inserting a tracheal tube, the tip of the tube must be guided through the epiglottis and further into the glottis. Thus, the tracheal tube is passed from the mouth to the larynx, and then through the epiglottis and glottis. However, the shape of the trachea from the mouth to the glottis in the larynx varies depending on the person and their posture, and is generally curved along the way. Therefore, a stylet is used to maintain the curve of the tracheal tube, making it easier to insert the tube into the trachea (see Patent Documents 1 and 2). [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Special Publication No. 2006-527027 [Patent Document 2] Special Publication No. 07-505317 Summary of the Invention [Problem to be solved by the invention]

[0005] The stylet described in Patent Document 1 is made of a flexible rod made of metal such as copper. Therefore, the tracheal tube with the stylet inserted can be curved to match the shape of the patient's trachea before intubation. This is expected to facilitate smooth intubation.

[0006] However, it is not easy to accurately determine the shape of a patient's trachea in advance. Therefore, there are cases where it is necessary to change the shape of the stylet while inserting the tracheal tube into the trachea. In such cases, the tracheal tube must be removed from the trachea, re-bent, and then re-inserted. However, repeated insertions like this waste valuable time during emergency treatment and place a significant burden on the patient. From the user's perspective, the operability of inserting the tracheal tube into the trachea is not good.

[0007] In this regard, the stylet described in Patent Document 2 comprises a flexible member (14) and a fixed-length filament (20), and the curved shape of the flexible member (14) can be changed by manipulating the handle while it is inserted into the tracheal tube.

[0008] However, the stylet in Patent Document 2 is configured such that the entire flexible member (14) is inserted into the tracheal tube and the entire flexible member (14) is bent to curve the tracheal tube. However, tracheal tubes are more rigid and difficult to bend than catheters. Therefore, a large force is required to change the shape of the stylet, and even if it can be changed, the tracheal tube interferes, limiting the degree of freedom of deformation, making it difficult to insert the tracheal tube into the trachea.

[0009] Therefore, an object of the present disclosure is to provide a stylet that allows a tracheal tube to be easily inserted into the trachea. [Means for solving the problem]

[0010] A stylet for assisting tracheal tube intubation according to a first aspect of the present disclosure comprises a shaft portion that is inserted into a tracheal tube having a distal opening and a proximal opening, and an operating device provided on the shaft portion that accepts operations to change the shape of the shaft portion, wherein the shaft portion has a distal protruding portion that protrudes from the distal opening when inserted into the tracheal tube from the proximal opening, and a proximal inserted portion that is positioned within the tracheal tube, and the protruding portion has an easily deformable portion that is more easily deformed than the inserted portion when the operating device is operated.

[0011] In this case, the protruding portion of the shaft that protrudes from the tracheal tube can be easily bent to fit the shape of the patient's trachea by operating the operating device during intubation. The tracheal tube is then advanced into the trachea along the bent protruding portion. This allows the tracheal tube to be guided into the trachea, making it easy to insert the tracheal tube into the trachea.

[0012] In the stylet according to the second aspect of the present disclosure, in the first aspect, the insertion portion may have a distal insertion portion and a proximal insertion portion that is located proximal to the distal insertion portion and has higher rigidity than the distal insertion portion.

[0013] This allows the shaft to be deformed to conform to the shape of the trachea using the relatively low-rigidity distal end insertion portion, while ensuring good pushability of the stylet using the more rigid proximal end insertion portion, thereby improving operability.

[0014] In the stylet according to the third aspect of the present disclosure, in the second aspect, the inserted portion has a distal axial member provided in the distal inserted portion, a proximal axial member provided in the proximal inserted portion and having higher rigidity than the distal axial member, and a covering tube that covers the distal axial member and the proximal axial member, and the proximal end of the distal axial member and the distal end of the proximal axial member may be fixedly connected to each other.

[0015] This makes it easy to achieve a distal end inserted portion and a proximal end inserted portion with different rigidities. Also, by fixing and connecting the distal end axial member and the proximal end axial member to each other, it is possible to prevent the ends of each axial member from rubbing strongly against the inner surface of the covering tube when the shaft is bent, thereby reducing wear on the covering tube.

[0016] In the stylet according to the fourth aspect of the present disclosure, in the first aspect, the operating device may have a support portion that supports the base end of the shaft, a grip portion that is located closer to the tip along the shaft than the support portion, and an operating portion that is provided on the grip portion and accepts operations to deform the protruding portion.

[0017] This allows deformation of the protruding portion at the tip end of the shaft to be performed at a portion (e.g., the middle portion) closer to the tip end than the base end of the shaft, thereby shortening the distance from the operating position to the deformation portion and improving operability.

[0018] A stylet according to a fifth aspect of the present disclosure is the stylet of the first aspect, wherein the operating device may have a fixing portion that removably fixes the base end of the tracheal tube into which the shaft is inserted.

[0019] This allows the tracheal tube to be fixed to the stylet during the tracheal tube intubation procedure, thereby improving operability during the intubation procedure, for example, by allowing the integrated tracheal tube and stylet to be held and operated in one hand. [Effects of the Invention]

[0020] According to the present disclosure, a stylet can be provided that allows an inserted tracheal tube to be easily bent during an intubation procedure. [Brief explanation of the drawings]

[0021] [Figure 1] FIG. 1 is a perspective view showing the external configuration of a stylet according to the present disclosure. [Figure 2] FIG. 2 is a side view of the stylet and tracheal tube. [Figure 3] FIG. 3A is a side view of the stylet with part of the manipulator removed to expose the inside, and FIG. 3B is a side view showing the stylet of FIG. 3A connected to a tracheal tube. [Figure 4] Figure 4A is a cross-sectional view showing the configuration of the stylet in a "first state" in which the tip portion of the shaft is straight, and Figure 4B is a cross-sectional view showing the configuration of the stylet in a "second state" in which the tip portion of the shaft is curved. [Figure 5] FIG. 5 is an enlarged view of a portion V enclosed by a two-dot chain line rectangle in FIG. 4A. [Figure 6] FIG. 6 is an enlarged view of a portion VI enclosed by a two-dot chain line rectangle in FIG. 4A. [Figure 7] FIG. 7 is a cross-sectional view showing the detailed configuration of the operating device. [Figure 8] FIG. 8 is a schematic diagram showing deformation of the protruding portion of the shaft portion 10. In FIG. DETAILED DESCRIPTION OF THE INVENTION

[0022] A stylet for assisting tracheal tube intubation according to an embodiment of the present disclosure will be described below with reference to the drawings. Note that the concept of direction used in the following description is used for convenience of explanation and does not limit the orientation of each disclosed configuration to that direction. Furthermore, the holder described below is merely one embodiment of the present disclosure. Therefore, the present disclosure is not limited to the following embodiment, and additions, deletions, or modifications to the configuration are possible within the scope of the disclosure.

[0023] FIG. 1 is a perspective view of a stylet 1. As shown in FIG. 1, the stylet 1 includes a rod-shaped shaft portion 10 and a manipulator 30, and is used by inserting the shaft portion 10 into a tracheal tube 100 (see FIG. 2). As will be described in detail below, the stylet 1 according to the present disclosure is configured so that when the tracheal tube 100, into which the shaft portion 10 is inserted, is fixed to the manipulator 30, the distal portion of the shaft portion 10 protrudes from the distal end of the tracheal tube 100. That is, the shaft portion 10 has a distal protruding portion 10A that protrudes from the distal end of the tracheal tube 100 when inserted into the tracheal tube 100, and a proximal inserted portion 10B that is located within the tracheal tube 100. The user can manipulate the manipulator 30 to change the curve of the stylet 1 between a "first state" in which the protruding portion 10A of the shaft portion 10 is straight and a "second state" in which the protruding portion 10A is curved.

[0024] For ease of explanation, the following will define a first direction, a second direction, and a third direction as shown in Fig. 1. That is, the longitudinal direction of the shaft portion 10 is defined as the first direction. The direction perpendicular to the first direction is defined as the second direction, and the directions perpendicular to both the first and second directions are defined as the third direction.

[0025] FIG. 2 is a side view of the stylet 1 and the tracheal tube 100. The tracheal tube 100 has a transparent tube body 101 made of a synthetic resin such as polyvinyl chloride (PVC) or silicone. This tube body 101 is open at both a distal end 101f and a proximal end 101r. The dimensions of the tube body 101 can be selected arbitrarily, taking into consideration the patient's age and other factors, within the range of, for example, an inner diameter of 5.0 mm to 10.0 mm (2.0 mm to 10.0 mm, including pediatric versions) and a wall thickness of 1.0 mm to 2.2 mm (0.5 mm to 2.2 mm, including pediatric versions). The tube body 101 is also provided with a cuff 102, an inflation tube 103, a connector 104, and the like.

[0026] The cuff 102 is made of a highly flexible synthetic resin and has a bag shape, and is fitted around the tube main body 101 near the tip 101f. The inflation tube 103 is a flexible tube with a smaller diameter than the tube main body 101. The tip of the inflation tube 103 is connected to the base end of a lumen provided for the inflation tube 103 in the tube main body 101, and the tip of this lumen opens inside the cuff 102.

[0027] A pilot balloon 105 is attached to the proximal end of the inflation tube 103, and a syringe can be connected to the pilot balloon 105. Therefore, by operating the syringe connected to the pilot balloon 105, air can be supplied via the inflation tube 103 to inflate the cuff 102. Note that some tracheal tubes, such as those for children, do not have a cuff, and the stylet 1 according to the present disclosure can also be used to assist in intubation of such cuff-less tracheal tubes.

[0028] The connector 104 is connected to the base end 101r of the tube body 101. More specifically, the connector 104 has a disk-shaped flange 104a with a central hole and a diameter larger than the outer diameter of the base end 101r of the tube body 101. The connector 104 also has a cylindrical first connecting portion 104b with an outer diameter substantially the same as the inner diameter of the base end 101r of the tube body 101. The connector 104 also has a cylindrical second connecting portion 104c with an outer diameter smaller than that of the flange 104a.

[0029] The first connecting portion 104b and the second connecting portion 104c are positioned on either side of the flange 104a, and the flange 104a, the first connecting portion 104b, and the second connecting portion 104c are integrally molded from synthetic resin. The internal space of the first connecting portion 104b communicates with the internal space of the second connecting portion 104c through a central hole in the flange 104a. In this connector 104, the first connecting portion 104b is inserted into and connected to the proximal end 101r of the tube main body 101. Meanwhile, the second connecting portion 104c of the connector 104 is removably fixed (connected) to a stylet 1 (described below) during endotracheal intubation, and after the stylet 1 is removed, it is connected to, for example, an oxygen supply tube extending from an artificial respirator.

[0030] Such a tracheal tube 100 has a distal opening 100f and a proximal opening 100r. The distal opening 100f is an opening located at the distal end 101f of the tube body 101, and the proximal opening 100r is an opening located at the proximal end of the second connecting portion 104c of the connector 104. The distal opening 100f and the proximal opening 100r are in communication with each other via the internal spaces of the tube body 101 and the connector 104.

[0031] A stylet 1 according to the present disclosure is used when intubating such a tracheal tube 100 into a patient's trachea. Specifically, the stylet 1 is inserted into the tracheal tube 100 from its base end opening 100r to its tip end opening 100f.

[0032] Fig. 3A is a side view showing the configuration of the stylet 1 as viewed from the side with part of the operating device 30 removed to expose the interior. Fig. 3B is a side view showing the stylet 1 of Fig. 3A connected to a tracheal tube 100. Fig. 4A is a cross-sectional view showing the configuration of the stylet 1 in a "first state" in which the distal end of the shaft portion 10 is straight. Fig. 4B is a cross-sectional view showing the configuration of the stylet 1 in a "second state" in which the distal end of the shaft portion 10 is curved.

[0033] As shown in Figures 3A and 3B, during the intubation procedure for the tracheal tube 100, the shaft portion 10 of the stylet 1 is inserted into the tracheal tube 100. Then, as shown in Figure 3B, the base end (second connecting portion 104c) of the tracheal tube 100 is removably fixed within the operating device 30 of the stylet 1, and in this state the protruding portion 10A of the shaft portion 10 protrudes outward from the distal opening 100f of the tracheal tube 100. Furthermore, as shown in Figures 4A and 4B, the protruding portion 10A of the shaft portion 10 of the stylet 1 can be deformed into any curved state between a first state (Figure 4A) and a second state (Figure 4B) by operating the operating device 30.

[0034] Next, the configuration of the stylet 1 will be described in detail.

[0035] As shown in FIG. 2, the shaft portion 10 of the stylet 1 is composed of a first portion 11, a second portion 12, and a third portion 13, which are aligned from the distal end to the proximal end. Of these, the first portion 11, which is located closest to the distal end, constitutes the protruding portion 10A described above, while the second portion 12 and the third portion 13 constitute the inserted portion 10B. The protruding portion 10A has a length of approximately one-fourth of the overall length of the shaft portion 10, e.g., 40 mm to 90 mm. The protruding portion 10A has an easily deformable portion 14 that is more easily deformed than the inserted portion 10B when the manipulator 30 is operated. In the stylet 1 of the present disclosure, the easily deformable portion 14 is configured to bend in only one direction, which is a predetermined direction around the axis A1 of the shaft portion 10. Specifically, as indicated by the outline arrow in FIGS. 2 and 4B, the bending direction of the easily deformable portion 14 coincides with the second direction.

[0036] As shown in FIG. 4A, the shaft portion 10 includes a tube member 15, a wire 16, and an axial member 17. The tube member 15 has the same length as the entire length of the shaft portion 10 and is made of a transparent synthetic resin such as polyvinyl chloride. The tube member 15 has a rigidity sufficient to maintain its shape regardless of its position (orientation) in a natural state where no external force is applied, and is flexible enough to bend relatively easily with the force of a human hand. The tube member 15 of the present disclosure has a constant inner and outer diameter along its entire length and includes a distal portion 15A corresponding to the protruding portion 10A (first portion 11) of the shaft portion 10 and a proximal portion 15B corresponding to the inserted portion 10B (second portion 12 and third portion 13) of the shaft portion 10.

[0037] 5 is a schematic diagram showing the configuration of the vicinity of the protruding portion 10A of the shaft portion 10, and is an enlarged view of a portion V enclosed by a two-dot chain line rectangle in FIG. 4A. Note that in FIG. 5, the dimension in the first direction is shortened for ease of illustration. As shown in FIG. 5, a plurality of notches 18 are formed in the distal end portion 15A of the tube member 15. These notches 18 extend radially from the circumferential surface of the distal end portion 15A to a distance greater than the radial dimension of the tube member 15, and when viewed from the third direction, form a V-shape that opens in one direction in the second direction.

[0038] That is, when viewed from the third direction as shown in FIG. 5, the upper end of the V-shaped notch 18 is located on the outer surface of the tube member 15, and the lower end of the notch 18 is located in the internal space of the tube member 15. Therefore, the inside and outside of the tube member 15 are in communication with each other through the openings 19 formed by the notches 18. A plurality of such notches 18 are provided in the distal end portion 15A of the tube member 15, lined up along the first direction. On the other hand, no notches 18 are provided in the proximal end portion 15B. Therefore, the distal end portion 15A of the tube member 15 is more easily deformed (bends) in the second direction than the proximal end portion 15B.

[0039] A cover tube 20 is fitted to the distal end portion 15A of the tube member 15. The cover tube 20 is made of a material that is more flexible and softer than the tube member 15, and can deform in a manner that satisfactorily follows the deformation of the tube member 15. In the present disclosure, the cover tube 20 is made of a heat-shrinkable shrink tube, and is provided on the distal end portion 15A of the tube member 15 so as to cover all of the notches 18 from the outside and airtightly close them.

[0040] A wire 16 is inserted into the tube member 15. The wire 16 is a wire made of stainless steel or the like, and a tip 16f, which is one end of the wire 16 in the first direction, is positioned at the tip 15f of the tube member 15. More specifically, the tip 16f of the wire 16 is fixedly connected to the tip 15f of the tube member 15, and the connection point (position in the second direction) is offset in the second direction from the axis A1. In other words, the wire 16 passes through a position closer to the opening 19 than the axis A1. Meanwhile, as shown in FIG. 4A , the other end 16r of the wire 16 extends outward from the base end 15r of the tube member 15 and is engaged with the operating device 30 as described below.

[0041] As shown in Fig. 4A, an axial member 17 is inserted into the tube member 15 together with the wire rod 16. The axial member 17 is configured by two members, a distal axial member 21 and a proximal axial member 22, which have different rigidities and are coaxially connected to each other. The distal axial member 21 has substantially the same length as the second portion 12 of the shaft portion 10, and the proximal axial member 22 has substantially the same length as the third portion 13 of the shaft portion 10. The axial member 17 is not inserted into the first portion 11 of the shaft portion 10.

[0042] The base-side shaft member 22 is made of a material with higher rigidity than the tip-side shaft member 21. For example, the tip-side shaft member 21 is made of aluminum, and the base-side shaft member 22 is made of stainless steel. The tip-side shaft member 21 has a rigidity sufficient to maintain its shape regardless of its position when no external force is applied, and is flexible enough to bend through plastic deformation when subjected to the force of a human hand or a relatively small external force. On the other hand, the base-side shaft member 22 has a high rigidity sufficient to not bend easily with the force of a human hand. As an example, the Young's modulus of the tip-side shaft member 21 can be set to a value less than 100 GPa, and the Young's modulus of the base-side shaft member 22 can be set to a value between 100 GPa and 250 GPa.

[0043] In the shaft portion 10, the second portion 12, which is the portion having the distal shaft member 21, constitutes the "distal insertion portion" according to the present disclosure, and the third portion 13, which is the portion having the proximal shaft member 22, constitutes the "proximal insertion portion" according to the present disclosure. Due to the difference in rigidity between the shaft members 21 and 22, the third portion 13 of the shaft portion 10 is more rigid than the second portion. Therefore, the second portion 12 can be easily reshaped by the user before intubation and can be deformed in contact with the inner wall of the trachea during the intubation procedure, whereas the third portion 13 is less likely to deform than the second portion 12 and therefore exhibits pushability during intubation.

[0044] 6 is a cross-sectional view showing the internal structure of portion VI enclosed by a two-dot chain line rectangle in FIG. 4A. Portion VI includes the boundary between second portion 12 and third portion 13 in shaft portion 10, and therefore includes the joint between distal shaft member 21 and proximal shaft member 22 in shaft member 17.

[0045] 6, the distal end side shaft member 21 and the proximal end side shaft member 22 are fixedly connected to each other. Specifically, a recessed engaging portion 21a is formed at the proximal end 21r of the distal end side shaft member 21, and an engaged portion 22a shaped to match the engaging portion 21a is formed at the distal end 22f of the proximal end side shaft member 22. The distal end side shaft member 21 and the proximal end side shaft member 22 are abutted against each other with their axial centers aligned, and their contact surfaces (opposing surfaces) are fixedly connected with an adhesive or the like. Specifically, the orientation of one of the shaft members 21 and 22 in the shaft member 17 is fixed relative to the other, and even if the shaft member 17 is bent, the shaft center is fixed so as to bend continuously without being discontinuous, such as by bending at the connection point between the shaft members 21 and 22.

[0046] This prevents the joint between the distal-side shaft member 21 and the proximal-side shaft member 22 from coming loose, even when an external force is applied to the shaft portion 10 in a direction intersecting the axis A1 (the second direction or the third direction). That is, the tube member 15 forms a covering tube that covers the distal-side shaft member 21 and the proximal-side shaft member 22, and if the joints between these shaft members 21, 22 come loose, one or both ends of the shaft members 21, 22 may interfere with the inner surface of the tube member 15. In response to this, by fixedly connecting the shaft members 21, 22 as described above, interference between the corners at the ends of the shaft members 21, 22 and the inner surface of the tube member 15 is prevented.

[0047] The connection between the distal end shaft member 21 and the proximal end shaft member 22 is not limited to the above-described configuration. Other connection configurations may be used as long as the shaft members 21, 22 can be coaxially and fixedly connected to each other. For example, the proximal end 21r of the distal end shaft member 21 and the distal end 22f of the proximal end shaft member 22 may be connected by welding.

[0048] Next, the configuration of the controller 30 will be described in detail.

[0049] 1, the controller 30 has a controller body 31 having a rectangular parallelepiped shape that is long in the first direction, and a slider 32. The controller body 31 has two casings 31L, 31R that can be separated in the third direction, and an opening 34 is formed at the tip, which is one end in the first direction, so that the tracheal tube 100 can be received in the first space 33. The slider 32 is provided on one side in the second direction near the tip of the controller body 31, and is slidable along the first direction.

[0050] Hereinafter, for convenience of explanation, the first direction may also be referred to as the front-to-rear direction, in which case the distal end direction of the first direction may also be referred to as the forward direction, and the proximal end direction thereof may also be referred to as the rearward direction. Therefore, the opening 34 described above may also be said to be provided at the front end of the controller body 31. Furthermore, the second direction may also be referred to as the up-down direction, in which case the direction in which the slider 32 is positioned relative to the controller body 31 may also be referred to as the upward direction, and the opposite direction may also be referred to as the downward direction.

[0051] Fig. 7 is a cross-sectional view showing the detailed configuration of the controller 30, and is an enlarged view of the cross-sectional structure of the controller 30 shown in Fig. 4A. Note that the controller main body 31 shown in Fig. 7 has two casings 31L and 31R, of which one casing 31R has been removed, showing only the other casing 31L.

[0052] 7, the controller body 31 has a rectangular shape that is long in the front-to-rear direction (first direction) in a side view, with each of the four corners being chamfered to form an arc shape. An opening 34 is provided at the front end of the controller body 31, and a first space 33 extends rearward from the opening 34, with its rear end 33r located further rearward than the center position of the controller body 31 in the front-to-rear direction. The cross section of this first space 33 perpendicular to the front-to-rear direction has a rectangular shape (see FIG. 1).

[0053] Furthermore, the cross section of first space 33 perpendicular to the front-rear direction is larger than flange 104a of connector 104 of tracheal tube 100. That is, when viewed from the front-rear direction, the cross section of first space 33 has dimensions large enough to accommodate the entire flange 104a. Therefore, connector 104 of tracheal tube 100 can be freely inserted and removed from first space 33 of operating device 30 in the direction along axis A1 (see FIG. 1) (see FIGS. 3A and 3B).

[0054] At the rear of the first space 33, there is provided a first fixing portion 35 to which the connector 104 of the tracheal tube 100 is connected, and a second fixing portion 36 to which the base end 15r of the tube member 15 of the stylet 1 (i.e., the base end portion of the shaft portion 10) is connected.

[0055] More specifically, a recessed portion 37 is provided at the rear of the first space 33, forming a space that extends further rearward from the rear end 33r of the first space 33. The internal space formed by the recessed portion 37 has a circular outline when viewed from the front-rear direction, and its inner diameter is approximately the same as the outer diameter of the cylindrical second connecting portion 104c of the connector 104. Furthermore, the front-rear dimension of the internal space of the recessed portion 37 is approximately the same as the front-rear dimension of the second connecting portion 104c.

[0056] A cylindrical portion 38 is provided inside the recessed portion 37. This cylindrical portion 38 extends forward from the rear end 37r of the recessed portion 37, and has an outer diameter slightly smaller than the inner diameter of the second connecting portion 104c of the connector portion 104, and the inner diameter is approximately the same as the outer diameter of the tube member 15. In addition, the front-rear dimension of the cylindrical portion 38 is shorter than the front-rear dimension of the recessed portion 37.

[0057] The first fixing portion 35 into which the connector 104 is fitted and connected is formed by the inner peripheral surface of the recessed portion 37. That is, when the second connecting portion 104c of the connector 104 is fitted into the first fixing portion 35, the outer peripheral surface of the second connecting portion 104c comes into contact with the inner peripheral surface of the recessed portion 37 (see also FIG. 3A ), thereby supporting the connector portion 104.

[0058] In this way, second connecting portion 104c is fitted into recessed portion 37 of first fixing portion 35 and connected to operating device 30. The inner diameter of recessed portion 37 is adjusted so that second connecting portion 104c can be press-fit into first fixing portion 35 with a slight force. Therefore, tracheal tube 100 is fixedly connected to operating device 30 and will not easily detach from operating device 30. However, the fit between tracheal tube 100 and operating device 30 is such that it can be detached manually. In other words, first fixing portion 35 removably fixes the base end portion (second connecting portion 104c) of tracheal tube 100.

[0059] The internal space of the cylindrical portion 38 forms a second fixing portion 36 into which the tube member 15 is fitted and connected. Because the inner diameter of the cylindrical portion 38 is substantially the same as the outer diameter of the tube member 15, the base end 15r of the tube member 15 is fitted into and positioned in the second fixing portion 36 with good alignment. A through-hole 39 penetrating in the front-to-rear direction is formed in the rear end wall 38r of the cylindrical portion 38. The wire 16 inserted in the tube member 15 protrudes from the base end 15r of the tube member 15 and extends rearward through this through-hole 39.

[0060] A second space 40 is provided in the rear of the controller body 31, at the rear portion of the rear end wall 38r. A guide portion 41 extending in a third direction, i.e., the left-right direction, protrudes from the second space 40. The guide portion 41 has a shape resembling the rear portion of a cylinder whose axis is oriented in the left-right direction and which is divided into two halves, front and rear, along the axis. Therefore, the rear surface of the guide portion 41 forms a guide surface 42 that has a curved shape that bulges rearward. The lower end of the guide portion 41 is substantially aligned with the through hole 39 in the up-down direction. The wire 16 extending rearward from the through hole 39 extends from the lower end to the upper end along the guide surface 42 of the guide portion 41. This changes the extending direction of the wire 16 from rear to front.

[0061] A slider accommodating portion 44 is provided at the top of the controller body 31. The slider accommodating portion 44 forms an accommodating space 45 that extends in the front-to-rear direction and has a rectangular cross section, and the rear end of the accommodating space 45 communicates with the upper part of the second space 40. The slider accommodating portion 44 has an opening 46 at its front that opens upward and forward. The slider 32 is accommodated in the slider accommodating portion 44.

[0062] The slider 32 has a slide portion 50 that is long in the front-to-rear direction, and an operating portion 51 that protrudes upward from the front of the slide portion 50. The slide portion 50 has a rectangular shape when viewed from the front-to-rear direction, and is housed in the housing space 45 of the slider housing portion 44 so that it can slide in the front-to-rear direction without rattle. The operating portion 51 protrudes from the front of the slide portion 50 and also protrudes upward from the opening 46 of the housing space 45.

[0063] A groove 52 extending in the front-rear direction and opening downward and forward is formed in the lower front portion of the slide portion 50. A through-hole 53 penetrating in the front-rear direction is formed in the rear portion of the slide portion 50. This through-hole 53 opens at the rear end of the groove 52 at its front end and at the rear end of the slide portion 50 at its rear end. The vertical position of the through-hole 53 is approximately aligned with the upper end of the guide portion 41. The wire 16 extending along the guide surface 42 extends forward through the through-hole 53, and the base end 16r of the wire 16 protrudes from the through-hole 53 into the groove 52 and is engaged therein.

[0064] In this type of controller 30, the second fixing portion 36 located at the rear portion of the controller body 31 forms a support portion 60 that supports the base end portion of the shaft portion 10. Furthermore, the front portion of the controller body 31 where the operating portion 51 is located, i.e., the portion closer to the tip end along the shaft portion 10 than the support portion 60, forms a grip portion 61 with which the user grips the controller 30. The operating portion 51 is provided on the grip portion 61 and receives an operation to deform the protruding portion 10A of the shaft portion 10, more specifically, an operation by the user to slide the slider 32 in the forward and backward directions.

[0065] Next, the operation and usage of the stylet 1 will be described.

[0066] In the first state shown in FIG. 4A , the stylet 1 has the slider 32 positioned at the rear. From this state, the user operates the slider 32 while holding the grip portion 61 of the controller 30 with one hand. For example, when holding the stylet 1 with the right hand, the user holds the controller body 30 in a "pen grip" by placing the side of the middle finger on one side 61L ( FIG. 1 ) of the grip portion 61 of the controller body 31, placing the side of the thumb on the other side 61R ( FIG. 1 ) of the grip portion 61, and placing the bottom surface 61B ( FIG. 1 ) of the grip portion 61 in the space between the thumb and index finger (the so-called first interdigital space). In other words, the bottom surface 61B serves as the first interdigital space placement portion, and the side surface 61L and the other side surface 61R serve as finger holding portions. Then, the user presses the operating unit 51 with the tip of the index finger, which is extended upward from the grip portion 61, to slide the slider 32 forward.

[0067] As a result, tension is generated in the wire 16, pulling the base end 16r forward. Because the extending direction of the wire 16 is redirected midway by the guide portion 41, tension is generated in the wire 16 in a direction that pulls the tip 16f rearward. In addition, the tip 16f of the wire 16 is engaged with the tip 15f of the tube member 15 of the shaft portion 10. Therefore, a compressive force acts on the tube member 15 in the front-to-rear direction.

[0068] The manner in which grip portion 61 is held and operated is not limited to the "pen grip" described above. For example, grip portion 61 may be held as if grasping it from above (this grip is referred to as a "bat grip" here), and the thumb may be used to push operating device 51 and slide slider 32. However, the "pen grip" allows for finer movements using the wrist of the hand holding grip portion 61 than the "bat grip." Therefore, while gripping grip portion 61, it is easier to rotate grip portion 61 around the axis of tracheal tube 100 and insert it into the trachea following the curved shape of tracheal tube 100.

[0069] Figure 8 is a schematic diagram showing the deformation state of the protruding portion 10A of the shaft portion 10, where the upper diagram of Figure 8 shows a first state in which the protruding portion 10A is straight, and the lower diagram of Figure 8 shows a second state in which the protruding portion 10A is curved.

[0070] As shown in Figure 8, when the slider 32 is operated to slide forward as described above with the stylet 1 in the first state, a compressive force acts in the front-to-rear direction on the tubular member 15. This causes the distal end portion 15A of the tubular member 15 to deform so that the openings 19 of the notches 18 close. As a result, as shown in the lower diagram of Figure 8, the protruding portion 10A of the shaft portion 10 bends in the second direction so that the tip faces upward (see also Figure 4B).

[0071] Furthermore, when the operating unit 51 is moved backward from the second state, the tension in the wire 16 is reduced. Then, the distal end portion 15A of the tube member 15 returns to the first state due to its own elastic force. In this way, the protruding portion 10A of the shaft 10 can assume any curved state between the first state and the second state depending on the operating position of the operating unit 51, depending on the balance between the tension in the wire 16 and the elastic force of the tube member 15.

[0072] Meanwhile, an axial member 17 is inserted into the inserted portion 10B of the shaft portion 10. Therefore, while the protruding portion 10A is deformed in the second direction by operating the operating unit 51, the inserted portion 10B does not deform in the second direction or deforms to a lesser extent than the protruding portion 10A. In other words, the protruding portion 10A is more easily deformed than the inserted portion 10B when the operating device 30 is operated. As such, the protruding portion 10A forms the easily deformable portion 14 according to the present disclosure and is more easily deformed than the inserted portion 10B regardless of the rigidity of the tracheal tube 100. Since the easily deformable portion 14 is formed in the protruding portion 10A protruding distally from the tracheal tube, the shaft can be bent without being affected by the rigidity of the tracheal tube, even when the shaft portion 10 is inserted into the tracheal tube 100. The easily deformable portion 14 may be the entire protruding portion 10A or a portion of the protruding portion 10A.

[0073] Such a stylet 1 is used by inserting it into a tracheal tube 100 during an intubation procedure. That is, the user inserts the shaft portion 10 of the stylet 1 into the tracheal tube 100 from the proximal end opening 100r, and then fits and fixes the second connecting portion 104c of the connector 104, which is the proximal end of the tracheal tube 100, into the first fixing portion 35 inside the operating device 30. When the tracheal tube 100 is fixed to the operating device 30, as shown in FIG. 3B , the protruding portion 10A of the shaft portion 10 of the stylet 1 protrudes from the distal end opening 100f of the tracheal tube 100, and the inserted portion 10B of the shaft portion 10 is located inside the tracheal tube 100.

[0074] In this manner, the intubation procedure is performed with the stylet 1 and tracheal tube 100 integrated. For example, the patient is placed on their back with their chin up (sniffing position), and the user inserts the blade of the laryngoscope into the oral cavity with their left hand and presses against the vicinity of the epiglottis. This opens the epiglottis, making it easier to visualize the glottis. In this state, the user grasps the gripping portion 61 with their right hand and inserts the stylet 1 and tracheal tube 100, which are integrated as described above, from the oral cavity into the trachea.

[0075] Before inserting the stylet 1 and tracheal tube 100 into the trachea, the tracheal tube 100 can be curved appropriately. That is, the second section 12 of the shaft portion 10 of the stylet 1 is configured to be plastically deformable by hand, as described above. Therefore, by deforming the second section 12 in advance according to the shape of the patient's trachea ascertained before intubation, the integrated stylet 1 and tracheal tube 100 can be formed into a shape that facilitates insertion into the trachea.

[0076] On the other hand, there are cases where it is necessary to change the shape of the tracheal tube 100 during intubation. For example, because it is not possible to completely grasp the shape of the deepest part of the patient's trachea in advance, a laryngoscope equipped with a camera may be used during intubation, and intubation may be performed while checking the deep part of the trachea on a monitor. If the shape of the tracheal tube 100 during intubation does not match the tracheal shape confirmed on the monitor, it is desirable to change the shape of the tracheal tube 100 even during intubation.

[0077] In such a case, with the stylet 1 according to the present disclosure, the protruding portion 10A of the shaft portion 10 protruding from the tracheal tube 100 is deformed by operating the operating device 30. This operation can be achieved by operating the operating unit 51 with the fingertips of the hand holding the gripping portion 61 of the operating device 30. Then, with the protruding portion 10A appropriately deformed and positioned in the trachea where the tracheal tube is to be inserted, the tracheal tube 100 is detached from the operating device 30 and moved toward the tip of the shaft portion 10. As a result, the tracheal tube 100 is inserted into the trachea along the shaft portion 10, which has been deformed according to the shape of the patient's trachea.

[0078] When the tracheal tube 100 is inserted to an appropriate position in the trachea, the stylet 1 is removed from the tracheal tube 100. Then, air is fed through the inflation tube 103 to inflate the cuff 102. This secures the patient's airway via the tracheal tube 100.

[0079] As can be seen from the above description, in the stylet 1 according to the present disclosure, the protruding portion 10A of the shaft portion 10 that protrudes from the tracheal tube 100 can be deformed by operating the operating device 30, even during the intubation procedure. Because the protruding portion 10A is not inserted into the tracheal tube 100, it can be deformed relatively easily without interference from the tracheal tube 100. Furthermore, after bending the protruding portion 10A, the tracheal tube 100 is advanced into the trachea along the protruding portion 10A, allowing the tracheal tube 100 to be properly intubated into the trachea.

[0080] The configuration of a stylet according to the present disclosure is not limited to the configuration of the stylet 1 described above. For example, the stylet 1 described above has been exemplified as having a shaft portion 10 with three different configurations (first portion 11, second portion 12, and third portion 13), but the configuration is not limited to this. For example, the shaft portion may be configured with only two different portions, the protruding portion and the inserted portion, or the inserted portion may be configured with three or more different portions so that the rigidity increases toward the base end.

[0081] In addition, although the above example illustrates a configuration in which the base end 21r of the tip-side shaft member 21 is formed in a concave shape and the tip end 22f of the base-end-side shaft member 22 is formed in a convex shape as a connection mode of the shaft members 21, 22, the present invention is not limited to this. For example, the base end 21r of the tip-side shaft member 21 may be formed in a convex shape, and the tip end 22f of the base-end-side shaft member 22 may be formed in a concave shape that matches the base end 21r.

[0082] Although the configuration in which the protruding portion 10A has a plurality of cutouts 18 as the easily deformable portion 14 is illustrated, the present invention is not limited to this. For example, the protruding portion 10A may have a bellows-like configuration at one side of the axial center A1 in the second direction in the tube member 15A.

[0083] Furthermore, a scale may be provided on the circumferential surface of the proximal end of the shaft portion 10 of the stylet 1 to serve as a guide for understanding the relative positions of the stylet 1 and the tracheal tube 100 in the front-to-rear direction. For example, a line is provided around the circumferential surface as the scale on the circumferential surface of the inserted portion 10B of the shaft portion 10 at a position distal to the operating device 30. Furthermore, a plurality of such lines are provided at intervals in the first direction.

[0084] When the user releases the tracheal tube 100 from the stylet 1 and inserts the tracheal tube 100 deeper into the trachea during intubation, the user can determine how far the tracheal tube 100 has moved toward the distal end relative to the stylet 1 from the positional relationship between the base end of the tracheal tube 100 and the line. This allows the user to easily position the tracheal tube 100 at an appropriate position in the patient's trachea. [Industrial Applicability]

[0085] The present disclosure can be suitably applied to a stylet for assisting in tracheal tube intubation. [Explanation of symbols]

[0086] 1 Stylet 10 Shaft section 10A protruding part 10B Interpolation part 11 Part 1 12 Second part (tip side insert part) 13 Third part (proximal insertion part) 14 Easily deformable part 15 Tube material (covering material) 17 Shaft member 21 Tip side shaft member 22 base end shaft member 30 Controller 35 1st fixed part (fixed part) 36 Second fixed part 60 Support part 61 Gripping part 100 Tracheal Tubes 100f Tip opening 100r proximal opening

Claims

1. a shaft portion used by being inserted into a tracheal tube having a distal opening and a proximal opening; and an operating device provided on the shaft portion and configured to accept an operation for changing the shape of the shaft portion, the shaft portion has a distal-end side protruding portion that protrudes from the distal-end opening when inserted into the tracheal tube from the proximal-end opening, and a proximal-end side inserted portion that is positioned within the tracheal tube, The protruding portion has an easily deformable portion that is more easily deformed than the inserted portion when the operating device is operated. A stylet to assist with tracheal tube intubation.

2. The insertion portion has a distal insertion portion and a proximal insertion portion that is located proximal to the distal insertion portion and has higher rigidity than the distal insertion portion. The stylet for assisting tracheal tube intubation according to claim 1.

3. the inserted portion includes a distal-side axial member provided in the distal-side inserted portion, a proximal-side axial member provided in the proximal-side inserted portion and having higher rigidity than the distal-side axial member, and a covering tube covering the distal-side axial member and the proximal-side axial member, The base end portion of the distal end side shaft member and the distal end portion of the proximal end side shaft member are fixedly connected to each other. The stylet for assisting tracheal tube intubation according to claim 2.

4. The operating device has a support part that supports a base end part of the shaft, a grip part that is located on the distal end side along the shaft relative to the support part, and an operating part that is provided on the grip part and receives an operation to deform the protruding part. The stylet for assisting tracheal tube intubation according to claim 1.

5. The operating device has a fixing portion that detachably fixes the base end portion of the tracheal tube into which the shaft is inserted. The stylet for assisting tracheal tube intubation according to claim 1.

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