Stylet for assisting tracheal tube intubation

The stylet addresses the challenge of airway shape variability by allowing the tracheal tube to be precisely shaped using a variable tip stylet, reducing the need for repeated insertions and enhancing intubation efficiency and safety.

JP2025077263APending Publication Date: 2025-05-19NIPRO CORP +1
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Patent Information

Application Number
JP2023189328
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Filing Date
2023-11-06
Publication Date
2025-05-19

AI Technical Summary

Technical Problem

Existing stylets for tracheal tube intubation require repeated bending and reinsertion due to the variability of airway shapes, leading to time loss and patient burden in emergency treatments.

Method used

A stylet with a shaft portion that has a variable tip shape, allowing for deformation by an operating device, and a second portion with higher rigidity to maintain the tracheal tube's shape, facilitating precise intubation without repeated insertions.

Benefits of technology

The stylet enables precise shaping of the tracheal tube to match the patient's airway, reducing the need for repeated insertions and improving the efficiency and safety of intubation procedures.

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Abstract

To provide a stylet capable of preventing repetition of insertion and extraction of a tracheal tube.SOLUTION: A stylet 10 comprises a shaft part 11 used by being inserted into a tracheal tube 1 and having a tip with a variable shape, and an operation device 12 receiving an operation to change the shape of the tip of the shaft part 11. The shaft part 11 includes a first portion 13, the tip, whose shape is variable due to operation on the operation device 12, and which is located in the tracheal tube when in use, and a second portion 14 located on a base end side with respect to the tip, having higher rigidity than the tracheal tube 1, and which does not deform due to operation on the operation device 12 or which has an amount of deformation due to operation on the operation device 12 less than the first portion 13.SELECTED DRAWING: Figure 2
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Description

Technical Field

[0001] The present disclosure relates to a stylet that is used as an auxiliary when inserting a tracheal tube.

Background Art

[0002] In the medical field, for example, during general anesthesia, cardiopulmonary resuscitation, or before artificial respiration, a tracheal tube is inserted into the trachea of a patient to secure the airway. The tracheal tube has a flexible tube with openings at both the tip and the base, and an inflatable cuff is provided near the tip. Such a tracheal tube is inserted from the patient's mouth into the airway, and air is supplied to and inflated in the cuff with the cuff positioned deeper than the glottis. As a result, the patient's lungs communicate with the outside through the internal space of the flexible tube, while the airway outside the flexible tube is blocked (filled) by the cuff. Then, the patient's respiration is managed by connecting a ventilator to the opening at the base of the flexible tube in this state.

[0003] Also, the glottis of a person is in the larynx that connects the trachea and the pharynx, and the larynx is divided into an upper glottis closer to the outside and a lower glottis farther from the outside (closer to the lungs) with the glottis as the boundary. And there is an epiglottis in the upper glottis. Therefore, in the procedure of inserting a tracheal tube, it is necessary to guide the tip of the tube further into the glottis through the epiglottis. Thus, the tracheal tube is passed from the mouth through the larynx, and in the larynx, it passes through the epiglottis and the glottis in sequence. However, the shape of the airway from the mouth to the glottis of the larynx varies depending on the person and the posture, and generally curves in the middle. Therefore, a stylet is used as a means to pre-curve the tracheal tube in order to facilitate the insertion of the tracheal tube into the trachea (see Patent Document 1).

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] The stylet described in Patent Document 1 is made of a metal such as copper and is composed of a flexible rod. Therefore, the tracheal tube with the stylet inserted can be bent in advance to match the airway shape of the patient before intubation. As a result, smooth intubation is expected.

[0006] However, it is not easy to accurately grasp the patient's airway shape in advance. Therefore, during the insertion of the tracheal tube into the trachea, it may be found that the shape of the tracheal tube is not appropriate. In that case, the tracheal tube is removed from the trachea, bent again, and then inserted again. However, such repeated insertions result in a loss of precious time in emergency treatment and also impose a great burden on the patient.

[0007] Therefore, an object of the present disclosure is to provide an instrument that can prevent repeated insertion and removal of the tracheal tube.

Means for Solving the Problems

[0008] The stylet for assisting tracheal tube intubation according to the first aspect of the present disclosure includes a shaft portion that is inserted into the tracheal tube and has a variable tip shape, and an operating device that receives an operation for changing the shape of the tip portion of the shaft portion. The shaft portion has a first portion that is the tip portion and has a variable shape by an operation on the operating device and is located in the tracheal tube during use, and a second portion that is on the proximal side of the tip portion and has higher rigidity than the tracheal tube and does not deform or deforms less by an operation on the operating device than the first portion.

[0009] Thus, even during the tracheal intubation procedure of inserting the tracheal tube into the trachea, by the operator operating the operating device, the shape of the tip of the shaft portion can be deformed, and even a relatively rigid tracheal tube can be deformed into an appropriate shape. For example, a person's airway generally changes its bending degree near the epiglottis. Therefore, by adopting the above-described configuration, the amount of bending of the first portion can be changed before the tip of the tracheal tube reaches the vicinity of the epiglottis and after passing through that position. Further, even if the shape of the distal end side of the tracheal tube is deformed in this way, the shape on the operator's side can be maintained substantially constant by the second portion having higher rigidity than the tracheal tube, so the operability of the tracheal tube during intubation is high. As a result, repeated insertion and removal of the tracheal tube can be eliminated, and the burden on the patient can be reduced.

[0010] In the stylet according to the second aspect of the present disclosure, in the first aspect, the first portion may be variable only in a predetermined one direction around the axis of the shaft portion.

[0011] Although the bending degree of a person's airway varies, the bending direction is constant. Therefore, by adopting the configuration as described above, deformation of the tracheal tube in a direction different from the bending direction of the airway can be prevented.

[0012] In the stylet according to the third aspect of the present disclosure, in the first aspect, the proximal end of the first portion may be located on the proximal end side of the cuff that the tracheal tube has in a state of being inserted into the tracheal tube.

[0013] In the tracheal intubation procedure, the tracheal tube is positioned further inward of the glottis where the cuff is behind the epiglottis. Therefore, by adopting the configuration as described above, when the tip portion including the cuff of the tracheal tube enters deeper than the epiglottis, the bending shape of the tip portion can be changed, so an appropriate intubation procedure can be performed.

[0014] The stylet according to the fourth aspect of the present disclosure, in the first aspect, the shaft portion may include a tube member having at least a portion corresponding to the first portion being flexible and having a length over the entire length of the shaft member, a wire inserted into the tube member, one end of which is positioned at the tip of the tube member and the other end of which is engaged with the operating device, and a shaft member disposed in a region corresponding to the second portion within the tube member.

[0015] Thereby, a shaft portion composed of the shape-variable first portion and the second portion that is more difficult to deform than the first portion as described above can be simply and suitably realized.

[0016] The stylet according to the fifth aspect of the present disclosure, in the fourth aspect, at least a portion of the tube member corresponding to the first portion may be externally provided with a cover tube that is more flexible than the tube member.

[0017] Thereby, when the first portion is in a curved state, the unevenness of the outer surface shape can be covered by the cover tube, and the friction when contacting the inner surface of the tracheal tube can be reduced.

[0018] The stylet according to the sixth aspect of the present disclosure, in the first aspect, the operating device may be rotatable around the axis of the shaft portion with respect to the shaft portion.

[0019] Thereby, for example, even when the operator operating the shaft portion and the operator operating the operating device are different, the shaft portion and the operating device can be gripped and operated in a convenient posture for each, and the convenience is good.

Effects of the Invention

[0020] According to the present disclosure, it is possible to provide a device that can prevent repeated insertion and extraction of the tracheal tube.

Brief Description of the Drawings

[0021]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

[0022] (Embodiment 1) Hereinafter, a stylet for assisting tracheal tube intubation according to an embodiment of the present disclosure will be described with reference to the drawings. Note that the concept of direction used in the following description is for convenience in explanation and does not limit the orientation of each disclosed configuration to that direction. Also, the stylet described below is only one embodiment of the present disclosure. Therefore, the present disclosure is not limited to the following embodiments, and additions, deletions, or changes to the configuration are possible without departing from the spirit of the disclosure.

[0023] FIG. 1 is a schematic diagram showing a state of a tracheal intubation procedure using the stylet according to the present disclosure. As shown in FIG. 1, in tracheal intubation, the patient 100 is placed in a supine position with the chin raised (sniffing position). This is to make it easier to visually recognize the glottis 105 when inserting the tracheal tube 1 from the oral cavity 101 of the patient 100 to the back of the glottis 105. However, there is an epiglottis 104 near the bifurcation of the esophagus 102 and the trachea 103 at the back of the oral cavity 101, and it is difficult to visually recognize the glottis 105 located behind the epiglottis 104 only in the sniffing position.

[0024] Therefore, in the tracheal intubation procedure, a laryngoscope 2 is used in combination. The laryngoscope 2 has a rod-shaped handle 2a and a blade 2b that extends bent from the tip of the handle 2a. The operator can hold the handle 2a, insert the blade 2b into the oral cavity, and open the epiglottis 104 by pressing near the base of the epiglottis 104. When the epiglottis 104 is opened, the glottis 105 can be visually recognized at the back, making it easier to insert the tracheal tube 1 into the back of the glottis 105.

[0025] However, the airway from the oral cavity 101 through the epiglottis 104 to the back of the glottis 105 is generally curved in the middle, and its curved shape varies depending on the patient and their posture. To smoothly insert the tracheal tube 1 into such a curved airway, a stylet 10 is used to pre-curve the tracheal tube 1 according to the airway shape. The stylet 10 is long and rod-shaped, can be curved and maintain the curved state, and can curve the tracheal tube 1 by curving it while inserted through the tracheal tube 1. Note that the stylet 10 is inserted through the tracheal tube 1 and used in the tracheal intubation procedure, and is pulled out from the tracheal tube 1 after intubation.

[0026] Figure 2 is a schematic diagram showing the configurations of the tracheal tube 1 and the stylet 10. As shown in Figure 2, the tracheal tube 1 has a transparent tube body 3 made of a synthetic resin such as polyvinyl chloride (PVC) or silicone. The tube body 3 has an open tip 3a and a base end 3b. As the dimensions of the tube body 3, for example, the inner diameter is 5.0 mm or more and 10.0 mm or less (when including pediatric use, 2.0 mm or more and 10.0 mm or less), and the wall thickness is 1.0 mm or more and 2.2 mm or less (when including pediatric use, 0.5 mm or more and 2.2 mm or less). It can be arbitrarily selected considering the age of the patient 100, etc. Also, the tube body 3 is provided with a cuff 4, an inflation tube 5, a connector 6, etc.

[0027] The cuff 4 is made of a highly flexible synthetic resin, forms a bag shape, and is externally mounted near the tip 3a of the tube body 3. The inflation tube 5 is a flexible tube with a smaller diameter than the tube body 3, is provided so as to span inside and outside the tube body 3, and its tip opens inside the cuff 3. A pilot balloon 7 is attached to the base end of the inflation tube 5, and a syringe can be connected to the pilot balloon 7. Therefore, by operating the syringe connected to the pilot balloon 7, air can be supplied through the inflation tube 5 to inflate the cuff 4.

[0028] The connector 6 is connected to the base end 3b of the tube body 3. More specifically, the connector 6 has a flange 6a that has a larger diameter than the outer diameter of the base end 3b of the tube body 3 and has a central hole. Further, the connector 6 has a cylindrical first connection portion 6b having an outer diameter substantially the same as the inner diameter of the base end 3b of the tube body 3. Furthermore, the connector 6 has a cylindrical second connection portion 6c having an outer diameter smaller than that of the flange 6a.

[0029] These first connection portion 6b and second connection portion 6c are positioned sandwiching the flange 6a, and the flange 6a, the first connection portion 6b, and the second connection portion 6c are integrally molded by synthetic resin. Also, the internal space of the first connection portion 6b communicates with the internal space of the second connection portion 6c through the central hole of the flange 6a. Such a connector 6 has the first connection portion 6b inserted and connected to the base end 3b of the tube body 3. On the other hand, the second connection portion 6c of the connector 6 is connected to a stylet 10 described later during the procedure of inserting the endotracheal tube, and after the stylet 10 is removed, it is connected to, for example, an oxygen supply tube extending from a ventilator.

[0030] The stylet 10 used during the intubation of the tracheal tube 1 as described above includes a shaft portion 11 that is inserted into the tracheal tube 1 and has a variable tip shape, and an operating device 12 that receives an operation for changing the shape of the tip portion of the shaft portion 11. The shaft portion 11 has an elongated rod shape, and at the tip portion in its longitudinal direction, it has a first portion 13 whose shape is variable by an operation on the operating device 12 and which is located inside the tracheal tube 1 during use, and a second portion 14 on the proximal side of the first portion 13. The second portion 14 is configured to have higher rigidity than the tracheal tube 1, and further, it is configured not to be deformed by an operation on the operating device 12 or to have a smaller amount of deformation by an operation on the operating device 12 than the first portion 13. Also, as the dimensions of the shaft portion 11, for example, in the range where the outer diameter is 4.0 mm or more and 9.0 mm or less (when including those for pediatric use, 2.0 mm or more and 9.0 mm or less), it can be selected according to the inner diameter of the tracheal tube 1 to be used.

[0031] Note that the longitudinal dimension of the shaft portion 11 is smaller (shorter) than the longitudinal dimension of the tube body 3 of the tracheal tube 1, and the tip of the shaft portion 11 inserted into the tube body 3 does not protrude from the opening of the tip 3a of the tube body 3. Also, in the shaft portion 11, the longitudinal dimension of the first portion 13 is smaller than the longitudinal dimension of the second portion 14. Further, the proximal end 13a of the first portion 13 is located on the proximal side by a length L from the cuff 4 in a state where the shaft portion 11 is inserted into the tube body 3.

[0032] Also, the operating device 12 includes an operating device body 15 having a gripping portion 16 that is gripped by hand by an operator who operates it, and a connecting portion 17 to which the shaft portion 11 and the tracheal tube 1 are connected, and a lever 18 that is operated by hanging a finger. In the stylet 10 of the present disclosure, the proximal end of the shaft portion 11 is connected to the operating device 12. Then, when the operator grips the gripping portion 16 and pulls the lever 18, the first portion 13 of the shaft portion 11 is variable so as to bend in a predetermined direction. Note that in the stylet 10 according to the present disclosure, the shaft portion 11 is configured to bend only in one direction in a predetermined direction around its axis.

[0033] FIG. 3A is a schematic view showing the configuration in the vicinity of the first portion 13 of the shaft portion 11, and shows a cross section in a plane along the axis. FIG. 3B is a schematic view showing the configuration of the operating device 12. With reference to FIGS. 3A and 3B, the configuration of the stylet 10 will be described in more detail. Hereinafter, the longitudinal direction of the shaft portion 11 is referred to as the first direction, the direction in which the shaft portion 11 bends orthogonally to the first direction is referred to as the second direction, and the direction orthogonal to both the first direction and the second direction is referred to as the third direction.

[0034] As shown in FIG. 3A, the shaft portion 11 has a tubular member 20 having a circular tube shape with a length extending over the entire length of the shaft portion 11. The tubular member 20 has a closed tip 21 and an open base end 22, and is made of a synthetic resin such as hard polyvinyl chloride and has transparency. The tubular member 20 has a rigidity such that it can maintain its shape regardless of its posture (orientation) in a natural state where no external force is acting. Further, the tubular member 20 has a first portion 23 corresponding to the first portion 13 of the shaft portion 11 and a second portion 24 corresponding to the second portion 24 of the shaft portion 11. The tubular member 20 has flexibility such that at least the first portion 23 can be bent relatively easily by the force of a human hand. In the tubular member 20 according to the present disclosure, both the first portion 23 and the second portion 24 have the same degree of flexibility.

[0035] In the first portion 23 of the tube member 20, a plurality of notches 25 are formed. The notches 25 are notches that extend radially from the circumferential surface of the first portion 23 across the axis A1 of the tube member 20, and when viewed from the third direction, they form a V-shape that opens in the bending direction (the above-mentioned "one direction of the predetermined direction") of the second direction. Also, as shown in FIG. 3A, when viewed from the third direction, the upper ends of the V-shaped notches 25 are located on the outer surface of the tube member 20, and the lower ends of the notches 25 are located in the internal space of the tube member 20. Therefore, the tube member 20 is in a state where the inside and outside communicate with each other through the opening 26 formed by the notch 25. In the first portion 23, a plurality of such notches 25 are provided side by side in the first direction. Therefore, the first portion 23 of the tube member 20 is more likely to bend in the bending direction than the second portion 24.

[0036] A cover tube 40 is externally mounted on the first portion 23 of the tube member 20. The cover tube 40 is made of a material with higher flexibility than the tube member 20 and can deform well following the deformation of the tube member 20. Also, in the present disclosure, this cover tube 40 is composed of a heat-shrinkable shrink tube and is provided in a state of covering all the notches 25 from the outside with respect to the first portion 23 of the tube member 20.

[0037] A wire 30 is inserted into the tube member 20. The wire 30 is a wire made of stainless steel or the like, and the tip 31, which is one end in the second direction, is positioned at the tip 21 of the tube member 20. More specifically, the tip 31 of the wire 30 is fixedly connected to the tip 21 of the tube member 20, and the connection location is offset to the bending direction side with respect to the axis A1. Therefore, the wire 30 passing through the inside of the tube member 20 passes through a position closer to the opening 26 than the axis A1. On the other hand, the other end 32 of the wire 30 extends outward from the base end 22 of the tube member 20 and is engaged with an operating device 12 as will be described later.

[0038] The shaft member 35 is inserted into the tube member 20 together with the wire 30. The shaft member 35 is a rigid rod-shaped member made of, for example, copper or aluminum. The shaft member 35 can be plastically deformed and bent by the force of a human hand, and has rigidity that can maintain its shape regardless of its posture when no external force is applied. The shaft member 35 is shorter than the tube member 20 and has substantially the same length as the second portion 24 of the tube member 20, and is provided in a region corresponding to the second portion 24. That is, the tip 36 of the shaft member 35 is located on the proximal side of the first portion 23 of the tube member 20, and the proximal end 37 of the shaft member 35 is located substantially at the same position as the proximal end 22 of the tube member 20.

[0039] In this way, the wire 30 passes through the entire length of the tube member 20 including the first portion 23 and the second portion 24, while the shaft member 35 does not pass through the first portion 23 and only passes through the second portion 24. Therefore, the second portion 14 of the shaft portion 11 can be bent when a force is applied by a human hand, and the bent shape is maintained because the internal shaft member 35 is plastically deformed. On the other hand, the first portion 13 of the shaft portion 11 is bent by operating the operating device 12 to pull the wire 30 toward the proximal end side.

[0040] As shown in FIG. 3B, the operating device 12 includes an operating device main body 15 and a lever 18, and the operating device main body 15 has a gripping portion 16 and a connecting portion 17. The connecting portion 17 generally has a cylindrical shape and has an opening 50 facing one direction. The inner side of the opening 50 has a multi-step shape, and a first connecting recess 51 to which the connector 6 of the tracheal tube 1 is connected, a second connecting recess 52 to which the proximal end of the shaft portion 11 is connected, and a through hole 53 through which the wire 30 passes are formed.

[0041] The first connection recess 51 has a cylindrical internal space having substantially the same diameter as the outer diameter of the second connection portion 6c of the connector 6 of the tracheal tube 1. Accordingly, the second connection portion 6c of the connector 6 is supported so as to be fitted into the first connection recess 51. Further, the second connection recess 52 is formed so as to open to the back surface (bottom surface) of the first connection recess 51 and to be coaxial with the first connection recess 51. The second connection recess 52 has a cylindrical internal space, the diameter of which is smaller than the diameter of the internal space of the first connection recess 51 and is substantially the same as the outer diameter of the tube member 20 of the shaft portion 11. Accordingly, the proximal end 22 of the tube member 20 is supported so as to be fitted into the second connection recess 52. The through hole 53 extends inward of the operating device body 15 from the back surface (bottom surface) of the second connection recess 52, and the wire 30 extending from the proximal end 22 of the tube member 20 is passed therethrough.

[0042] As described above, since the tracheal tube 1 is supported by being fitted into the first connection recess 51, the tracheal tube 1 and the operating device body 15 are relatively rotatable about the axis of the tracheal tube 1. Similarly, since the shaft portion 11 is supported by being fitted into the second connection recess 52, the shaft portion 11 and the operating device body 15 are relatively rotatable about the axis of the shaft portion 11.

[0043] Thereby, even when the shaft portion 11 of the stylet 10 is inserted into the tracheal tube 1, the tracheal tube 1 and the shaft portion 11 can be relatively rotated with respect to the operating device 12. Accordingly, even if the person who operates the tracheal tube 1 and the person who operates the operating device 12 are different in the endotracheal tube, the tracheal tube 1 and the operating device 12 can be turned and operated in directions that are easy for each person to operate.

[0044] Note that, of the first connection recess 51 and the second connection portion 6c, a circumferential groove extending in the circumferential direction may be provided in either one, and a circumferential projection extending in the circumferential direction may be provided in the other. Then, when the tracheal tube 1 is connected to the operating device 12 by fitting the second connection portion 6c of the connector 6 into the first connection recess 51, the circumferential projection on one side is engaged with the circumferential groove on the other side so as to snap in. Thereby, the connection of the tracheal tube 1 to the operating device 12 is made reliable to prevent detachment, and the operating device 12 and the tracheal tube 1 can be relatively rotatable around the axis of the tracheal tube 1.

[0045] The operating device main body 15 pivotally supports one end of the lever 18, and the base end 32 of the wire 30 extending into the operating device main body 15 through the through hole 53 is connected to this lever 18. More specifically described, the lever 18 has an elongated rod shape and is arranged so as to straddle the virtual extension line of the through hole 53. One end 18a in the longitudinal direction of the lever 18 is pivotally supported at a predetermined position within the operating device main body 15, and the other end 18b extends outside the operating device main body 15. The base end 32 of the wire 30 is connected at a position between one end 18a and the other end 18b of the lever 18.

[0046] Such a lever 18 is rotatable with the pivotally supported one end 18a as the center and the other end 18b along the extending direction of the wire 30 (the first direction in FIG. 3B). Then, when a force is applied to rotate the lever 18 in one direction (the right direction in FIG. 3B) of the first direction, the wire 30 is pulled in the same direction. Further, when the application of the force to the lever 18 is released, the lever 18 rotates in the other direction (the left direction in FIG. 3B) of the first direction and returns to the original position by the tension applied to the wire 30, and the wire 30 also returns in the same direction.

[0047] The operating unit main body 15 is provided with a gripping portion 16 at a position opposite to the connecting portion 17 with reference to the pivot position of the lever 18. The gripping portion 16 generally has a columnar shape and extends in a direction slightly inclined with respect to the extending direction (first direction) of the wire 30. The gripping portion 16 has dimensions (axial length and circumferential length) suitable for being gripped by a human hand. Further, in the operating unit main body 15, a finger-hooking portion 19 protrudes at a position opposite to the gripping portion 16 with reference to the lever 18. Therefore, a person operating the operating unit 12 holds the gripping portion 16, for example, with the thumb, ring finger, and little finger of the hand, and while hanging the index finger on the finger-hooking portion 19, hangs the middle finger on the lever 18 and rotates it.

[0048] With the stylet 10 configured as described above, by operating the lever 18 of the operating unit 12, the first portion 13 of the shaft portion 11 can be bent. The upper diagram of FIG. 4 shows the state of the first portion 13 of the shaft portion 11 in the non-operated state of the lever 18, and the lower diagram shows the state of the first portion 13 of the shaft portion 11 in the operated state of the lever 18. With reference to this FIG. 4, the bending of the shaft portion 11 will be described in more detail.

[0049] When in the non-operated state where no force is applied to the lever 18, the first portion 13 of the shaft portion 11 forms a substantially linear shape as shown in the upper diagram of FIG. 4. On the other hand, when the lever 18 is rotationally operated, the first portion 13 of the shaft portion 11 bends as shown in the lower diagram of FIG. 4. Specifically, since the tension of the wire 30 increases due to the operation of the lever 18, a compressive stress along the axial direction acts on the tube member 20. As a result, the first portion 23 of the tube member 20 deforms so that each notch 25 closes and bends. On the other hand, the second portion 24 of the tube member 20 has no notch and a highly rigid shaft member 35 is inserted therein, so it hardly deforms or does not deform at all depending on the operation of the lever 18.

[0050] The degree of curvature of the first portion 13 of the shaft portion 11 is determined according to the operation amount (rotation amount) of the lever 18. That is, the larger the operation amount of the lever 18, the more the first portion 13 curves and the smaller the radius of curvature becomes. Further, the curved shape of the first portion 13 of the shaft portion 11 is maintained while the operation position of the lever 18 is maintained. Then, when the force applied to the lever 18 is weakened, the lever 18 rotates in the direction of returning to the original position due to the tension applied to the wire 30. As a result, the tension applied to the wire 30 becomes smaller, and the compressive stress acting on the tube member 20 also becomes smaller. As a result, due to the elasticity of the tube member 20, the degree of bending of the tube member 20 becomes smaller (the radius of curvature becomes larger), and when the lever 18 is in a non-operated state, the shaft portion 11 returns to a straight shape (the upper figure in FIG. 4).

[0051] With such a configuration, according to the stylet 10 according to the present disclosure, during the tracheal intubation procedure, by the operator operating the operating device 12, the first portion 13, which is the tip of the shaft portion 11 located in the tracheal tube 1, can be arbitrarily curved, and appropriate intubation can be performed.

[0052] In the case of the stylet 10 described above, the tip 21 of the tube member 20 is closed, and all of the plurality of notches 25 provided in the tube member 20 are covered by the cover tube 40. That is, the internal space of the tube member 20 is hermetically and liquid-tightly closed with respect to the outside of the tube member 20. Therefore, among the stylets 10 used for tracheal intubation, the operating device 12 located outside the oral cavity 101 of the patient 100 and the shaft member 35 inside the tube member 20 are less likely to be contaminated by the body fluid of the patient 100 or the like, and thus the possibility of reuse is increased.

[0053] (Embodiment 2) FIG. 5 is a schematic diagram showing the configuration of a stylet according to another embodiment. While the stylet 10 according to Embodiment 1 has a configuration that is operated by a human hand, the stylet 10A according to the present embodiment has a configuration that is operated by a human foot.

[0054] This stylet 10A includes a shaft portion 11 having a tube member 20, a wire 30, a shaft member 35, and a cover tube 40, which have the same configuration as the stylet 10 described in Embodiment 1. In the stylet 10A according to the present embodiment, the shaft portion 11 is connected to a foot pedal type operating device 12A via a connection portion 60 and a connecting tube 65.

[0055] Specifically, the proximal end 22 of the tube member 20 is connected to the connection portion 60. This connection portion 60 generally has a cylindrical shape, has a first connection recess 61 and a second connection recess 62 on one side, has a third connection recess 63 on the other side, and further has a communication hole 64 that communicates the internal space on one side with the internal space on the other side.

[0056] The configurations of the first connection recess 61 and the second connection recess 62 are the same as those of the first connection recess 51 and the second connection recess 52 of the connection portion 17 of the operating device 12 described in Embodiment 1. Therefore, the second connection portion 6c of the connector 6 of the tracheal tube 1 is fitted and supported in the first connection recess 61, and the proximal end 22 of the tube member 20 of the shaft portion 11 is fitted and supported in the second connection recess 62. Further, the third connection recess 63 of the connection portion 60 is a recess that forms a cylindrical internal space, and one end 65a of a connecting tube 65 that connects the shaft portion 11 and the operating device 12A is fitted and connected here. Furthermore, the communication hole 64 of the connection portion 60 communicates the back surface (bottom surface) of the second connection recess 62 with the back surface (bottom surface) of the third connection recess 63, and the wire 30 extending from the proximal end 22 of the tube member 20 is passed through.

[0057] The other end 65b of the connecting tube 65 is connected to the operating device 12A, and the other end 32 of the wire 30 passing through the inside is engaged with the operating device 12A. Specifically described, the operating device 12A includes a casing 70 and a foot pedal 80. The casing 70 has a rectangular parallelepiped box shape, and an opening 71 is formed over the entire front surface area thereof. A cylindrical connecting portion 73 is erected on the upper wall 72 of the casing 70, and the inside and outside of the casing 70 communicate with each other through the connecting portion 73. The other end 65b of the connecting tube 65 is fitted and connected to the connecting portion 73, and the other end 32 of the wire 30 inserted into the connecting tube 65 extends further from the other end 65b of the connecting tube 65 and is introduced into the casing 70.

[0058] A substrate 75 extends forward from the lower front end of the casing 70. This substrate 75 is configured by extending the bottom wall 74 of the casing 70, and the upper surface of the bottom wall 74 and the lower surface of the substrate 75 are flush flat surfaces.

[0059] A pivot support portion 76 projects on the upper surface of the substrate 75, and this pivot support portion 76 pivotally supports the proximal end 81 of the foot pedal 80. The foot pedal 80 has a rectangular and plate-like shape, and is generally arranged with its main surface facing in the vertical direction and spanning the opening 71 across the inside and outside of the casing 70. The proximal end 81, which is one end in the longitudinal direction of the foot pedal 80, is rotatably supported by the pivot support portion 76 as described above, and the other end 32 of the wire 30 is connected to the distal end 82. Therefore, the foot pedal 80 is rotatable about the proximal end 81 so that the distal end 82 is displaced in the vertical direction between the upper position Pu and the lower position Pd.

[0060] When the foot pedal 80 is in the upper position Pu, such a stylet 10A has a straight shaft portion 11. When the foot pedal 80 is depressed with a person's foot in this state, the foot pedal 80 descends from the upper position Pu and is displaced to the lower position Pd. Then, as the foot pedal 80 descends, the wire 30 is pulled. As a result, as described in the first embodiment, a compressive stress acts on the tube member 20, causing the first portion 23 to bend, and the first portion 13 of the shaft portion 11 also bends similarly.

[0061] The degree of bending of the first portion 13 of the shaft portion 11 is determined according to the operation amount (depression amount) of the foot pedal 80. That is, the larger the operation amount of the foot pedal 80, the more the first portion 13 bends and the smaller the radius of curvature becomes. Also, the bent shape of the first portion 13 of the shaft portion 11 is maintained while the operation position of the foot pedal 80 is maintained. When the force applied to the foot pedal 80 is weakened, due to the tension applied to the wire 30, the foot pedal 80 rotates in the direction of returning to its original position. As a result, the tension applied to the wire 30 decreases, and the compressive stress acting on the tube member 20 also decreases. As a result, due to the elasticity of the tube member 20, the degree of bending of the tube member 20 decreases (the radius of curvature increases), and when the foot pedal 80 is in a non-operated state, the shaft portion 11 returns to a straight shape.

[0062] Thus, according to the stylet 10A according to the second embodiment, similar to the stylet 10 of the first embodiment, during the tracheal intubation procedure, by the operator operating the operating device 12A, the first portion 13, which is the tip of the shaft portion 11, can be arbitrarily bent, and appropriate intubation can be performed. Also, since the operating device 12A is a foot pedal type, the operator's hands are free even during the operation of the operating device 12A. Therefore, when the person operating the tracheal tube 1 and the person operating the operating device 12 are the same in tracheal intubation, both hands can be used to operate the tracheal tube 1.

[0063] (Other Embodiments) In the above-described Embodiments 1 and 2, as the first portion 23 of the tube member 20, a configuration having a notch 25 was exemplified, but the present invention is not limited thereto. For example, the first portion 23 may have a bellows structure in which a plurality of alternately provided circumferential ridges and valleys are provided. Further, the tube member 20 is not limited to being made of a synthetic resin, and a metal pipe may be used. Further, the wire 30 may be composed of a single strand wire, or may be composed of a stranded wire formed by combining a plurality of strand wires. In addition, the configurations shown in Embodiments 1 and 2 are examples, and some of the configurations can be arbitrarily deleted and changed.

Industrial Applicability

[0064] The present disclosure can be suitably applied to a stylet for assisting tracheal tube intubation.

Explanation of Reference Numerals

[0065] 1 Tracheal tube 3 Tube body 4 Cuff 10 Stylet 11 Shaft portion 12 Operator 12A Operator 13 First portion 14 Second portion 20 Tube member 23 First portion 24 Second portion 25 Notch 30 Wire 35 Shaft member 40 Cover tube

Claims

1. The device includes a shaft portion that is inserted into a tracheal tube and has a variable tip shape, and an operating device that accepts an operation to change the shape of the tip of the shaft portion, The shaft portion is a first portion of the tip portion, the shape of which can be changed by operating the operating device and which is positioned inside the tracheal tube during use; a second portion that is located on the base end side of the tip portion and has higher rigidity than the tracheal tube, and is not deformed by an operation of the operation device, or the amount of deformation by an operation of the operation device is smaller than that of the first portion; A stylet to assist with tracheal tube intubation.

2. The first portion is movable only in one predetermined direction around the axis of the shaft portion. The stylet of claim 1 .

3. A proximal end of the first portion is located on the proximal side of a cuff of the tracheal tube when the tracheal tube is inserted into the tracheal tube. The stylet of claim 1 .

4. The shaft portion is a tube member having a length corresponding to at least the first portion and extending along the entire length of the shaft member; a wire that is inserted into the tube member, one end of which is positioned at the tip of the tube member and the other end of which is engaged with the operating device; a shaft member disposed in a region corresponding to the second portion within the tube member, The stylet of claim 1 .

5. A cover tube having a higher flexibility than the tube member is provided on at least a portion of the tube member corresponding to the first portion. The stylet of claim 4.

6. The operating device is rotatable around the axis of the shaft portion with respect to the shaft portion. The stylet of claim 1 .

Citation Information

Patent Citations

  • Intubation device

    JP2006527027A