Medical rod intubation assistance device
Patent Information
- Application Number
- JP2025031262
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2025-02-28
- Publication Date
- 2026-09-09
AI Technical Summary
【0023】 本開示によれば、曲げやすさと姿勢保持力とを好適なバランスで実現することができる医療用ロッドの挿管補助装置を提供することができる。
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Figure 2026144133000001_ABST
Abstract
Description
Technical Field
[0001] The present disclosure relates to an intubation assisting device that is auxiliary used when inserting a medical rod such as a tracheal tube into a body cavity. Background Art
[0002] In clinical medical settings, a tracheal tube is inserted into a patient's trachea to secure an airway, for example during general anesthesia, emergency resuscitation, or before artificial respiration. A tracheal tube includes a flexible tube having an open distal end and an open proximal end, and an inflatable / deflatable cuff is provided near the distal end of the flexible tube. Such a tracheal tube is inserted into the trachea through the patient's mouth, and with the cuff positioned deeper than the glottis, air is supplied to the cuff to inflate it. As a result, the patient's lung communicates with the outside through the inner space of the flexible tube, while the airway outside the flexible tube is occluded (occluded) by the cuff. Then, in this state, by connecting a ventilator to the opening at the proximal end of the flexible tube, the patient's respiration is managed.
[0003] In addition, the human glottis is located in the larynx connecting the trachea and the pharynx, and the larynx is divided with the glottis as a boundary into a supraglottic portion closer to the outside and a subglottic portion farther from the outside (closer to the lung). The epiglottis is located in the supraglottic portion. Therefore, in the procedure of inserting a tracheal tube, it is necessary to guide the distal end of the tube through the epiglottis further to the deep side of the glottis. As described above, the tracheal tube is passed from the mouth through the larynx, and in the larynx, it is sequentially passed through the epiglottis and the glottis. However, the shape of the trachea from the mouth to the glottis of the larynx varies depending on the person and posture, and is generally curved along the path. Accordingly, in order to facilitate insertion of the tracheal tube into the trachea, a stylet is used as a means for curving the tracheal tube (see Patent Document 1). Prior Art Documents Patent Documents
[0004] Patent Document 1 Japanese National Publication of International Patent Application No. 07-505317 Summary of the Invention [Problems that the invention aims to solve]
[0005] The stylet described in Patent Document 1 comprises a flexible member (14) and a fixed-length filament (20), and the curvature of the flexible member (14) can be changed during the intubation procedure by manipulating the prong while it is inserted into the tracheal tube. However, it is preferable for the stylet to have both appropriate flexibility and appropriate posture-holding ability. However, in the case of the stylet described in Patent Document 1, since the flexible member (14) is composed of a single long rod-shaped member, it is difficult to achieve such flexibility and posture-holding ability.
[0006] Therefore, the present disclosure aims to provide an intubation assist device for medical rods that can achieve a suitable balance between flexibility and posture-holding force. The intubation assist device of this disclosure can be applied to various medical rods, such as stylets and bougies. [Means for solving the problem]
[0007] A medical rod intubation assist device according to a first aspect of the present disclosure comprises a shaft having a plurality of blocks aligned in the axial direction, and including a movable shaft portion that can be bent in a first direction intersecting the axial direction by the relative postural displacement of two adjacent blocks; a wire provided so as to penetrate the plurality of blocks in the axial direction and applying the axial force to bend the movable shaft portion; and a linear core material provided so as to penetrate the plurality of blocks in the axial direction and applying a postural holding force to the movable shaft portion.
[0008] As a result, the movable shaft is composed of multiple blocks, making it easy to bend, and the core material enhances the ability to maintain posture against external loads during intubation procedures.
[0009] In the second aspect of the present disclosure, in the first aspect, one of two adjacent blocks is provided with a pivot shaft portion extending in a second direction perpendicular to both the axial direction and the first direction, and the other block is provided with a bearing portion through which the pivot shaft portion is inserted, and the pivot shaft portion is slid into the bearing portion and fitted into the bearing portion, and a hinge portion is formed which prevents the axial direction from coming out.
[0010] This allows the hinge mechanism to prevent the blocks from coming apart axially and also prevents twisting around the axis. Furthermore, because the blocks are secured to each other, only simple support is needed when passing wires or core materials through them, improving work efficiency.
[0011] In the third aspect of the present disclosure, in the first aspect, the movable shaft portion has a passage hole through the axis of the movable shaft portion in a space in which the core material is provided, and the wire may have a first wire and a second wire provided so as to sandwich the passage hole.
[0012] This allows the movable shaft to be bent in two directions: one in the first direction and the other in the second direction. Furthermore, because there is a core material between the first and second wires, the attitude-holding force exerted by the core material is the same regardless of whether the external load is from the first or second direction. In addition, it is easier to secure space for a through hole in the axial center, and the degree of freedom in selecting the diameter of the core material is increased.
[0013] In the fourth aspect of the present disclosure, in the first aspect, the movable shaft portion has a passage hole that extends in the axial direction and is a space in which the core material is provided, and the inner surface of the passage hole and the outer surface of the core material are configured to move relative to each other in the axial direction when the movable shaft portion is displaced in the first direction, and a radial gap may be provided between the inner surface of the passage hole and the outer surface of the core material.
[0014] This reduces the sliding resistance that occurs between the outer surface of the core material and the inner surface of the passage hole when the movable shaft is bent, making bending operations easier.
[0015] In the fifth aspect of the present disclosure, the intubation assist device, in the fourth aspect, has a core material in which one of its axial base end and tip end is fixed to the shaft, while the other end is not fixed to the shaft.
[0016] This allows for axial misalignment between the passage hole and the core material when bending the movable shaft, making it easier to bend. Furthermore, since only one end of the core material is fixed, even if the movable shaft twists, torsional loads are less likely to be applied to the core material and its fixing part, improving the durability of the core material and fixing part.
[0017] In the sixth aspect of the present disclosure, in the first aspect, the proximal end of the core material is located more towards the proximal end than the space between two adjacent blocks that are located furthest towards the proximal end in the movable shaft portion, and the tip of the core material is located more towards the tip than the space between two adjacent blocks that are located furthest towards the tip in the movable shaft portion.
[0018] As a result, a core material is provided in the area including all the spaces between the blocks that make up the movable shaft, and the core material can provide posture-holding force between all the blocks.
[0019] In the first embodiment, the intubation assist device according to the seventh aspect of the present disclosure may include a covering tube that covers the movable shaft portion and holds a plurality of the blocks.
[0020] This allows each block to be held securely by the covering tube, and also facilitates smooth insertion into the trachea during intubation. Furthermore, by providing a reduced-diameter section with a smaller outer diameter than the surrounding portion in the block located at the very tip of the movable shaft, and positioning the tip of the covering tube in this reduced-diameter section, the step difference between the outer surface of the movable shaft and the tip of the covering tube can be reduced.
[0021] In an intubation assistance device according to an eighth aspect of the present disclosure, in the first aspect, the shaft includes a resin tube-shaped proximal shaft portion located on a proximal end side relative to the movable shaft portion and coaxial with the movable shaft portion, and the wire includes: a first portion passing through an internal space of the proximal shaft portion; a second portion continuous from the first portion, passing through a proximal end side portion of the movable shaft portion, and heading outward in a radial direction of the shaft from the proximal end toward the distal end; and a third portion continuous from the second portion, heading toward the distal end side along the movable shaft portion, and located outward in the radial direction relative to the first portion, and a tube through which the first portion and the second portion of the wire pass may be provided inside the shaft.
[0022] According to this configuration, the radial positions of the wire differ between the first portion and the third portion, and the third portion is located radially outward compared to the first portion, so the deformability of the movable shaft portion when a pulling operation is performed is improved. In addition, since the first portion is located closer to the radial center of the proximal shaft portion, a wide range of thickness dimensions can be selected for the proximal shaft portion, and a member with a thickness that achieves suitable bending rigidity can be selected from among resin tubes that are relatively easily available. Furthermore, since the first portion of the wire only needs to be passed through the internal space of the tube member, there is no need to separately provide a lumen in the thick portion of the proximal shaft portion. Still further, by passing the portion from the first portion to the second portion through the tube, sliding resistance generated on the outer surface of the wire during operation can be reduced, and operability is improved. When a coil tube is used as the aforementioned tube, contact between the tube and the wire passing through the inside of the tube becomes point contact, which further reduces sliding resistance and improves operability. Effects of the Invention
[0023] According to the present disclosure, it is possible to provide an intubation assistance device for a medical rod that achieves a favorable balance between ease of bending and posture holding force. Brief Description of the Drawings
[0024] [Figure 1]Figure 1 is a schematic diagram showing the state of performing endotracheal intubation using a stylet, which is an intubation assisting device according to the present disclosure. [Figure 2] Figure 2 is a drawing showing the entire stylet, which also shows, in addition to the stylet, an operating device for operating the stylet, a tracheal tube, and a cover sleeve. [Figure 3] Figure 3 is a drawing showing the distal end portion including the movable shaft part of the stylet, and includes an external view, a longitudinal sectional view, and a longitudinal sectional view with a core member not illustrated. [Figure 4] Figure 4A is an external view of a first wire and a second wire, showing the state when they are passed through wire passage holes, and Figure 4B is an external view of a core member. [Figure 5] Figure 5A is a perspective view of an intermediate block, Figure 5B is a side view of the intermediate block, and Figure 5C is a longitudinal sectional view of the intermediate block. [Figure 6] Figure 6 is a side view showing a state where two intermediate blocks are fitted together. [Figure 7] Figure 7A is a perspective view of a proximal block, Figure 7B is a side view of the proximal block, and Figure 7C is a longitudinal sectional view of the proximal block. [Figure 8] Figure 8A is a perspective view of a distal block, Figure 8B is a side view of the distal block, and Figure 8C is a longitudinal sectional view of the distal block. [Figure 9] Figure 9A is an external view showing only blocks of the movable shaft portion of the assembled stylet that forms a linear shape, and Figure 9B is an external view showing a state where the movable shaft portion of Figure 9A is bent upward. Description of Embodiments
[0025] (1. Example of Use of Intubation Assisting Device) The intubation assistance device for medical rods described herein will be explained below with reference to the drawings. Here, a stylet will be used as an example of an intubation assistance device. A stylet is a device that assists in the intubation of a tracheal tube as a medical rod. However, the intubation assistance device described herein is not limited to a stylet and can also be applied to intubation assistance devices for bougies and other tubes inserted into body cavities, for example.
[0026] The concept of direction used in the following description is for illustrative purposes only and does not limit the orientation of each disclosed configuration to that direction. Furthermore, the intubation assist device described below is merely one embodiment of this disclosure. Therefore, this disclosure is not limited to the following embodiments, and additions, deletions, or modifications to the configuration are permitted without departing from the spirit of the disclosure.
[0027] Figure 1 is a schematic diagram showing the procedure of endotracheal intubation using the stylet 20, an intubation assist device according to this disclosure. As shown in Figure 1, in endotracheal intubation, patient 1 is in a supine position with their chin raised (sniffing position). This is to make it easier to visualize the glottis 6 when inserting the tracheal tube 10 from the oral cavity 2 to the back of the glottis 6. However, the epiglottis 5 is located near the branching point of the esophagus 3 and trachea 4 at the back of the oral cavity 2, and it is difficult to visualize the glottis 6, which is located behind the epiglottis 5, simply by being in the sniffing position.
[0028] Therefore, a laryngoscope 15 is used in conjunction with the endotracheal intubation procedure. The laryngoscope 15 has a rod-shaped handle 16 and a blade 17 that bends and extends from the tip of the handle 16. The operator grasps the handle 16, inserts the blade 17 into the oral cavity, and presses near the base of the epiglottis 5 to open the epiglottis 5. Once the epiglottis 5 is opened, the glottis 6 can be seen behind it, making it easier to insert the tracheal tube 10 behind the glottis 6.
[0029] However, the airway from the oral cavity 2 through the epiglottis 5 to the back of the glottis 6 is generally curved along its course, and the shape of this curve varies depending on the patient and their posture. To facilitate the insertion of the tracheal tube 10 into such a curved airway, a stylet 20 is used to pre-curve the tracheal tube 10 according to the shape of the airway. The stylet 20 is a long, rod-shaped object that is bendable and can maintain its curved state, and can be curved by bending it while it is inserted into the tracheal tube 10. The stylet 20 is inserted into the tracheal tube 10 during the endotracheal intubation procedure, and can be used so that the tip of the stylet 20 is exposed distal to the tip of the tracheal tube 10. After intubation, the stylet 20 is withdrawn from the tracheal tube 10.
[0030] The tracheal tube 10 has a transparent tube body made of synthetic resin such as polyvinyl chloride (PVC) or silicone, an inflatable cuff provided near the tip of the tube body, and further includes an inflation tube and connectors. The dimensions of the tube body are such that the inner diameter is 5.0 mm to 10.0 mm (2.0 mm to 10.0 mm if including pediatric tubes) and the wall thickness is 1.0 mm to 2.2 mm (0.5 mm to 2.2 mm if including pediatric tubes), and can be arbitrarily selected considering the age and body type of the patient 1.
[0031] (2. Overall structure) Figure 2 is a diagram showing the entire stylet 20, and in addition to the stylet 20, it also shows the actuator 12 for operating the stylet 20, the tracheal tube 10, and the cover sleeve 11. The stylet 20 comprises a long, rod-shaped shaft 21, a wire 24 and a core material 26 (see Figure 3) passing through the shaft 21, and the base end (rear end) of the shaft 21 is supported by the actuator 12. The actuator 12 has a gripping part 12a that the user holds with their hand, and an operating part 12b that the user can operate in the forward and backward directions with their fingertips while holding the gripping part 12a. When the user operates the operating part 12b forward or backward, the wire 24 inside the shaft 21 is pushed and pulled, causing the tip portion (front end portion) of the shaft 21 to curve in the vertical direction.
[0032] Such a stylet 20 is covered with a cover sleeve 11 when in use. The cover sleeve 11 comprises a mounting portion 11a and a sleeve portion 11b extending forward from the mounting portion 11a. The mounting portion 11a has a through hole through which the shaft 21 is inserted and is configured to be detachable from a predetermined location on the actuator 12. The sleeve portion 11b is a long cylindrical shape with an internal space communicating with the through hole of the mounting portion 11a, and its end is closed. Therefore, when the shaft 21 is inserted into the sleeve portion 11b, the shaft 21 is sealed and contamination from the outside is prevented. The sleeve portion 11b is made of a soft, film-like synthetic resin or the like that does not affect the deformation (bending) of the stylet 20.
[0033] When performing the intubation procedure for the tracheal tube 10, the stylet 20, with the cover sleeve 11 described above, is inserted into the tracheal tube 10. The proximal end 10a of the tracheal tube 10 is then attached to the operating device 12. Thus, the stylet 20, cover sleeve 11, and tracheal tube 10 form a single unit and are all attached to the operating device 12. The stylet 20 has a resin tubular proximal shaft portion 22 located at the proximal end and a movable shaft portion 23 located at the tip of the proximal shaft portion 22. When the stylet 20 is inserted into the tracheal tube 10, the movable shaft portion 23 is exposed from the tip opening of the tracheal tube 10 toward the tip.
[0034] The above-described method of using the stylet 20 is merely an example and is not limited thereto. For example, the cover sleeve 11 may be omitted, and the stylet 20 may be inserted directly into the tracheal tube 10. However, using the cover sleeve 11 prevents contamination of the stylet 20 during the intubation procedure. Therefore, the cover sleeve 11 can be discarded after intubation, eliminating the need to clean the stylet 20.
[0035] In the following, as shown in Figure 2, the direction along the axis Ax of the stylet 20 is defined as the front-rear direction, and the curvature direction of the movable shaft portion 23 is defined as the up-down direction. The direction that intersects both the front-rear and up-down directions is defined as the left-right direction. However, the front end may also be called the tip, and the rear end may also be called the base.
[0036] (3. Stylet) Figure 3 is a drawing showing the tip portion of the stylet 20, including the movable shaft portion 23, and includes an external view, a longitudinal section view, and a longitudinal section view with the core material 26 not shown. The longitudinal section view is a cross-sectional view taken when the stylet is cut by a plane perpendicular to the left-right direction and passing through the axis Ax. The stylet 20 is provided with a movable shaft portion 23 at its tip. The movable shaft portion 23 is composed of a plurality of blocks 28 arranged in the front-rear direction. These blocks 28 include a base block 28A located at the rearmost position, a tip block 28C located at the frontmost position, and a plurality of intermediate blocks 28B located between the base block 28A and the tip block 28C.
[0037] The movable shaft portion 23 can bend vertically (in a first direction intersecting the axis Ax) by displacing the relative positions of two adjacent blocks 28, 28 among these blocks 28. Inside this movable shaft portion 23, there is one core material passage hole 31 extending in the front-rear direction and two wire passage holes 32 extending in the front-rear direction. The core material passage hole 31 passes through the axis Ax of the movable shaft portion 23 and forms a space in which the core material 26 is provided. The two wire passage holes 32 are formed so as to sandwich the core material passage hole 31 and form a space in which the wires 24 are provided.
[0038] In this embodiment, the core material passage hole 31 is formed coaxially with respect to the movable shaft portion 23, but it is not necessarily required that the two be coaxial. The two wire passage holes 32 are arranged symmetrically with respect to the core material passage hole 31, and the distance from the core material passage hole 31 to one wire passage hole 32 and the distance from the core material passage hole 31 to the other wire passage hole 32 are equal. One wire 24 (first wire 24A) is passed through one wire passage hole 32, and one wire 24 (second wire 24B) is passed through the other wire passage hole 32. The tips of these two wires 24 are fixed to the tip portion of the movable shaft portion 23, and their base ends are engaged with the actuator 12 by passing through the internal space of the base shaft portion 22.
[0039] Furthermore, in such a stylet 20, the base shaft portion 22 and the base block 28A are connected via a pipe member 37. Specifically, the pipe member 37 is, for example, a metal pipe-shaped member, into which the front end of the base shaft portion 22 is inserted through the rear end opening of the pipe member 37, and the rear end of the base block 28A is inserted through the front end opening. The front end of the base shaft portion 22 and the rear end of the base block 28A are then abutted together within the pipe member 37. By connecting the base shaft portion 22 and the base block 28A using a rigid pipe member 37 in this way, the base shaft portion 22 and the base block 28A can maintain coaxiality stably.
[0040] Furthermore, the section from the base end of the pipe member 37 to partway along the longitudinal direction of the tip block 28C is covered by a covering tube 38. The covering tube 38 is a cylindrical member made of a highly flexible resin film. The stylet 20 has its surface covered from the base shaft portion 22 to the tip block 28C by this covering tube 38. The configuration of the base shaft portion 22 is not particularly limited, but as an example, a thick-walled tube member made of synthetic resin, with a reinforcing wire spirally wound inside the wall embedded in it, can be used, which is a braided tube. The thickness dimension of the base shaft portion 22 made of the tube member can be selected as appropriate. For example, if one coil tube 34 (described later) is provided, a thickness dimension larger than the diameter of the coil tube 34 may be selected, and if two coil tubes 34 are provided, a thickness dimension larger than twice the diameter of the coil tubes 34 may be selected. Also, if no coil tube 34 is provided, a thickness dimension of 1.25 times or more the diameter of the wire 24 may be selected.
[0041] (3.1) Wire and core material Figure 4A shows the external view of the first wire 24A and the second wire 24B, illustrating their state when passed through the wire passage hole 32. Since the first wire 24 and the second wire 24B have similar configurations, they will be described simply as wire 24 without distinction.
[0042] The wire 24 is provided within the wire passage hole 32 so as to penetrate multiple blocks 28 in the front-rear direction (see Figure 3), and by operating the actuator 12 by the user, a force is applied to the movable shaft portion 23 in the direction along the axis Ax, causing the movable shaft portion 23 to bend in the vertical direction. The wire 24 is made of a metal wire, such as stainless steel. It is preferable that the diameter of the wire 24 is smaller than the inner diameter of the wire communication hole 31, but for example, a wire with a diameter smaller than the core material 26, less than 0.8 mm, may be used.
[0043] A cylindrical metal first cap 33 is fixedly attached to the tip of the wire 24 by welding or the like. The wire 24 is then passed through the wire passage hole 32 of the movable shaft portion 23, and the first cap 33 at the tip is connected to the tip block 28C by welding or the like. The base end of the wire 24 is inserted into the coil tube 34. The coil tube 34 is a tube member constructed by winding a metal wire, such as stainless steel, into a coil. When the wire 24 is passed through the wire passage hole 32, a radial gap C2 exists between the outer surface of the wire 24 and the inner surface of the wire passage hole 32 (see Figure 3).
[0044] Such a wire 24 has a first portion 241 that passes through the internal space of the base shaft portion 22, a second portion 242 that extends from the tip of the first portion 241 and passes through the base block 28A, and a third portion 243 that extends from the tip of the second portion 242. As can be seen from Figure 4A, in the upper wire 24 (first wire 24A), the second portion 242 extends upward as it goes forward, and the third portion 243 beyond it is located above the first portion. Similarly, in the lower wire 24 (second wire 24B), the second portion 242 extends downward as it goes forward, and the third portion 243 beyond it is located below the first portion. In the coil tube 34 described above, the first portion 241 and the second portion 242 of each wire 24 are inserted, and the third portion 243 is exposed.
[0045] Figure 4B is an external view of the core material 26. The core material 26 is provided within the core material passage hole 31 so as to penetrate the multiple blocks 28 in the front-rear direction (see Figure 3), and provides a posture-holding force to the movable shaft portion 23. This core material 26 is made of a metallic wire, such as stainless steel, is straight, and in this embodiment has a predetermined elasticity. The base end of the core material 26 is fixed to the movable shaft portion 23. When the core material 26 has a predetermined elasticity, the core material 26 can exert a posture-restoring force that returns the movable shaft portion 23 from a curved state to a straight state.
[0046] Specifically, a cylindrical metal second cap 35 is fixedly attached to the base end of the core material 26 by welding or the like. The core material 26 is then passed through the core material passage hole 31 of the movable shaft portion 23, and the second cap 35 at the base end is connected to the base end block 28A by welding or the like. Note that the tip and other parts of the core material 26, excluding the base end, are not fixed to the movable shaft portion 23. Alternatively, the core material 26 may be configured so that the tip is fixed to the movable shaft portion 23, but the other parts are not fixed to the movable shaft portion 23. In other words, it is acceptable to have a configuration where one of the tip and base ends is fixed and the other is not.
[0047] As shown in the cross-sectional view of Figure 3, the core material 26 has a length dimension extending from the base block 28A to the tip block 28C. More specifically, the base end of the core material 26 is located on the base side of the connection point P1 between the base block 28A and the intermediate block 28B adjacent to it in front. Also, the tip of the core material 26 is located on the tip side of the connection point P2 between the tip block 28C and the intermediate block 28B adjacent to it in rear. In other words, the core material 26 extends over a range that includes all the connection points between two adjacent blocks 28, 28.
[0048] It is more preferable that the diameter of the core material 26 is smaller than the inner diameter of the core material communication hole 32. More specifically, the core material 26 may be thicker than the wire 24, for example, and may be 0.5 mm to 1.2 mm in diameter. The core material 26 may be a single wire, a bundle or twist of thin wires, or a resin rod. It is more preferable that it has the desired elastic force.
[0049] When such a core material 26 is passed through the core material passage hole 31, a radial gap C1 is formed between the outer surface of the core material 26 and the inner surface of the core material passage hole 31 (see Figure 3). Furthermore, as described above, the base end of the core material 26 is fixed to the base end block 28A via the second cap 35, while the rest of the core material is not fixed. Therefore, when the movable shaft portion 23 is bent, the outer surface of the part of the core material 26 other than the base end and the inner surface of the core material passage hole 31 can move relative to each other in the direction along the axis Ax, reducing sliding resistance and making it easier to bend.
[0050] (3.2) Intermediate block Figure 5A is a perspective view of the intermediate block 28B, Figure 5B is a side view of the intermediate block 28B, and Figure 5C is a longitudinal cross-sectional view of the intermediate block 28B. As shown in Figure 5A, the intermediate block 28B is made up of a generally cylindrical member and has three holes that penetrate in the front-to-back direction. One of these holes is the first hole 41, which passes through the axis Ax of the intermediate block 28B and forms the core material passage hole 31. The other two holes are the second holes 42, which pass above and below the axis Ax, respectively, and form the wire passage holes 32.
[0051] A rotating shaft portion 50 is provided at the rear and vertical center of the intermediate block 28B, formed to protrude rearward. The rotating shaft portion 50 has a cylindrical shaft portion 55 and a support portion 51 that supports the shaft portion 55. The shaft portion 55 is an axis that extends in the left-right direction from the left end face to the right end face of the intermediate block 28B, and its vertical cross-section is circular with a predetermined outer diameter. The support portion 51 is the part that supports the shaft portion 55 at the rear of the intermediate block 28B and has the same left-right dimensions as the shaft portion 55.
[0052] As shown in Figure 5B, the support portion 51 has an upper first rear surface 51u and a lower first rear surface 51d. The upper first rear surface 51u is a surface that extends forward and upward from the front surface of the shaft portion 55, and the lower first rear surface 51d is a surface that extends forward and downward from the front surface of the shaft portion 55. These first rear surfaces 51u and 51d form a predetermined angle A1 in a side view and are symmetrical with respect to the axis Ax. Therefore, the support portion 51 has a triangular shape in which the vertical dimension decreases as it moves towards the rear, and supports the shaft portion 55 at its apex, which is the rear end portion.
[0053] Furthermore, the rear of the intermediate block 28B is provided with an upper second rear surface 52u and a lower second rear surface 52d. The upper second rear surface 52u is a surface that continues from the upper first rear surface 51u described above, and when viewed from the side, it extends upward and backward from the front end of the first rear surface 51u. This second rear surface 52u has a larger area than the first rear surface 51u. Similarly, the lower second rear surface 52d is a surface that continues from the lower first rear surface 51d described above, and when viewed from the side, it extends downward and backward from the front end of the first rear surface 51d. This second rear surface 52d also has a larger area than the first rear surface 51d. These second rear surfaces 52u and 52d form a predetermined angle A2 when viewed from the side and are symmetrical with respect to the axis Ax.
[0054] Thus, the rear portion of the intermediate block 28B has a concave shape that is generally recessed forward (or open to the rear) in a side view due to the large area of the second rear surfaces 52u and 52d, and has a rotating shaft portion 50 at its central position in the vertical direction.
[0055] A bearing portion 60 is provided at the front and vertical center of the intermediate block 28B, formed to be recessed to the rear. The bearing portion 60 is groove-shaped and extends in the left-right direction, with openings on both sides at the left and right end faces of the intermediate block 28B. The bearing portion 60 also has a circular cross-section with a predetermined inner diameter, which is slightly larger than the outer diameter of the shaft portion 55 described above.
[0056] The front of the intermediate block 28B is provided with a first front surface 61u extending upward from the bearing portion 60 and a first front surface 61d extending downward. The upper first front surface 61u is a surface extending forward and upward from the upper edge of the front opening of the bearing portion 60, and the lower first front surface 61d is a surface extending forward and downward from the lower edge of the front opening of the bearing portion 60. These first front surfaces 61u and 61d form a predetermined angle A3 in a side view and are symmetrical with respect to the axis Ax. The angle A4 formed by the first front surfaces 61u and 61d is greater than the angle A1 formed by the first rear surfaces 51u and 51d (A4 > A1).
[0057] Furthermore, the front of the intermediate block 28B is provided with an upper second front surface 62u and a lower second front surface 62d. The upper second front surface 62u is a surface that continues from the upper first front surface 61u described above, and when viewed from the side, it extends upward and backward from the front end of the first front surface 61u. This second front surface 62u has a larger area than the first front surface 61u. Similarly, the lower second front surface 62d is a surface that continues from the lower first front surface 61d described above, and when viewed from the side, it extends downward and backward from the front end of the first front surface 61d. This second front surface 62d also has a larger area than the first front surface 61d. These second front surfaces 62u and 62d form a predetermined angle A4 when viewed from the side and are symmetrical with respect to the axis Ax. Note that the angle A3 formed by the second front surfaces 62u and 62d is smaller than the angle A2 formed by the second rear surfaces 52u and 52d (A3 <A2)。
[0058] Thus, the front part of the intermediate block 28B has a convex shape that generally protrudes forward in a side view due to the second front surfaces 62u and 62d which have a large surface area, and has a bearing portion 60 at its central position in the vertical direction.
[0059] Furthermore, the first hole 41 of the intermediate block 28B described above opens to the rear by cutting out a part of the rotating shaft portion 50 at the center position in the left-right direction, and also opens to the front by cutting out a part of the bearing portion 60. In addition, the upper second hole 42 opens to the rear at the upper second rear surface 52u and to the front at the upper second front surface 62u, and the lower second hole 42 opens to the rear at the lower second rear surface 52d and to the front at the lower second front surface 62d.
[0060] Figure 6 is a side view showing the state in which the two intermediate blocks 28B are fitted together. When fitting the two intermediate blocks 28B together, the shaft portion 55 of the rotating shaft portion 50 of one intermediate block 28B and the bearing portion 60 of the other intermediate block 28B are arranged coaxially in the left-right direction, and from that state they are slid in the left-right direction to bring them closer together and fit together. That is, the rotating shaft portion 50 is inserted through the bearing portion 60, and the two intermediate blocks 28B are engaged. As a result, as shown in Figure 6, a hinge portion 70 is formed by the rotating shaft portion 50 of the front intermediate block 28B and the bearing portion 60 of the rear intermediate block 28B. In other words, the two intermediate blocks 28B are hinged together.
[0061] Furthermore, as shown in Figure 6, the diameter D of the shaft portion 55 of the rotating shaft portion 50 is larger than the opening width W, which is the vertical dimension of the opening to the front of the bearing portion 60. Therefore, the two interlocking intermediate blocks 28B are prevented from coming apart in the front-rear direction by the hinge portion 70. In addition, since the interlocking rotating shaft portion 50 and bearing portion 60 are elongated in the left-right direction, displacement of two adjacent intermediate blocks 28B around the axis Ax is suppressed.
[0062] Furthermore, as described above, the angle A1 formed by the first rear surfaces 51u, 51d is smaller than the angle A3 formed by the first front surfaces 61u, 61d, and the angle A2 formed by the second rear surfaces 51u, 52d is smaller than the angle A4 formed by the second front surfaces 62u, 62d. Therefore, as shown in Figure 6, when the two intermediate blocks 28B are positioned coaxially (in a straight line), a predetermined gap Cu is formed between the first rear surface 51u and the first front surface 61u, and between the second rear surface 52u and the second front surface 62u, which are opposite each other above the hinge portion 70. Similarly, a predetermined gap Cd is formed between the first rear surface 51d and the first front surface 61d, and between the second rear surface 52d and the second front surface 62d, which are opposite each other below the hinge portion 70. Thus, the two intermediate blocks 28B that engage with each other can be displaced vertically by rotating around the hinge portion 70.
[0063] The vertical rotation range of the two intermediate blocks 28B is defined by the gaps Cu and Cd described above, in other words, by the rear and front surfaces that face each other in the front-rear direction. Specifically, one limit position is when the upper first rear surface 51u and the upper first front surface 61u, which face each other, are in contact. The other limit position is when the lower first rear surface 51d and the lower first front surface 61d, which face each other, are in contact. Between these two limit positions, the two intermediate blocks 28B can be displaced (rotated) relative to each other.
[0064] Furthermore, in one of the angle limit positions described above, the upper second rear surface 52u and the second front surface 62u are positioned slightly apart and not in contact with each other, and in the other limit position, the lower second rear surface 52d and the second front surface 62d are also positioned slightly apart and not in contact with each other. This makes it possible to prevent steps from occurring in the middle of the wire communication holes 32 between adjacent blocks, or steps from occurring on the outer surfaces between blocks.
[0065] When the two intermediate blocks 28B engage, their respective first holes 41 are coaxially positioned in the front-to-back direction, forming a core material passage hole 31. Similarly, the upper second holes 42 of the two intermediate blocks 28B are coaxially positioned in the front-to-back direction to form an upper wire passage hole 32, and the lower second holes 42 are coaxially positioned in the front-to-back direction to form a lower wire passage hole 32.
[0066] (3.3) Base block Figure 7A is a perspective view of the base block 28A, Figure 7B is a side view of the base block 28A, and Figure 7C is a longitudinal cross-sectional view of the base block 28A. As shown in Figure 7A, the base block 28A is made up of a generally cylindrical member and, like the intermediate block 28B, is provided with three holes, namely one first hole 41 and two second holes 42. The first hole 41 passes through the axis Ax of the base block 28A and forms the core material passage hole 31. The second holes 42 pass above and below the axis Ax, respectively, and form the wire passage holes 32.
[0067] The base block 28A has a front portion 80 and a rear portion 81. Of these, the front portion 80 has the same shape as the front portion of the intermediate block 28B. That is, the front portion 80 of the base block 28A has a bearing portion 60, an upper first front surface 61u, a lower first front surface 61d, an upper second front surface 62u, and a lower second front surface 62d. These configurations have already been explained in the section on the intermediate block 28B, so a redundant explanation will be omitted here.
[0068] On the other hand, the rear portion 81 of the base block 28A is cylindrical, and its outer diameter is slightly smaller than that of the front portion 80. Therefore, a step 81a is provided around the entire circumference between the rear end of the front portion 80 and the front end of the rear portion 81, such that the higher portion 81 is lower than that of the front portion 80 (closer to the axis Ax).
[0069] Furthermore, a slit 82 is formed in the center of the rear section 81 in the left-right direction, extending from the upper end to the lower end. Therefore, the rear section 81 is configured with a semi-cylindrical left member 81L and a right member 81R arranged on either side of the slit 82. The slit 82 has the same width as the inner diameter of the second hole 42 that forms the wire passage hole 32, and the rear ends of the upper and lower second holes 42 that penetrate the front section 80 open toward the slit 82 of the rear section 81. In other words, each second hole 42 of the front section 80 communicates with the slit 82 of the rear section 81 at the opening at its rear end.
[0070] Furthermore, the rear end of the first hole 41, which penetrates the front portion 80, also opens toward the slit 82 of the rear portion 81. The inner diameter of the first hole 41 is larger than the width of the slit 82. However, on the two opposing wall surfaces of the left member 81L and the right member 81R, in the portion extending from the rearward extension of the first hole 41, a groove 83 is formed that is recessed in an arc shape and extends in the front-rear direction, increasing the width between the walls. When viewed along the front-rear direction, the contour of this groove 83 coincides with that of the first hole 41. In this way, a passage with the same spatial cross-sectional area as the first hole 41 is formed in the center of the slit 82 by the groove 83.
[0071] Since the base block 28A is equipped with a bearing portion 60, it is fitted into the rotating shaft portion 50 of the intermediate block 28B and hinged together. The manner of this hinge connection is the same as the manner of connection between the two intermediate blocks 28B described above. As will be described later, the second cap 35 of the base end of the core material 26 is fixed by welding or the like in the slit 82 of the rear portion 81 of the base block 29A, between the left and right grooves 83. In addition, the tip of the coil tube 41 is fixed to the wall surface of the slit 82 by welding or the like.
[0072] (3.4) Tip block Figure 8A is a perspective view of the tip block 28C, Figure 8B is a side view of the tip block 28C, and Figure 8C is a longitudinal cross-sectional view of the tip block 28C. As shown in Figure 8A, the tip block 28C is made up of a generally cylindrical member, and its length along the axis Ax is longer than that of the intermediate block 28B. For example, it has a length that is 30% to 60% of the length of the movable shaft portion 23 excluding the base block 28A, that is, the length from the connection position P1 in Figure 3 to the tip of the tip block 28C. The end face of the front end portion 90 of the tip block 28C is spherical, and a reduced diameter portion 91 with a smaller outer diameter than the surrounding portion is provided on the rear side of the front end portion 90. Therefore, a step 91a is formed between the front end portion 90 and the reduced diameter portion 91.
[0073] The tip block 28C has a main body portion 92 behind the reduced diameter portion 91. The outer diameter of the main body portion 92 is the same as the outer diameter of the front end portion 90. A vertical through hole 93 is formed near the center of the main body portion 92 in the front-rear direction, penetrating in the vertical direction.
[0074] The rear of the main body 92 has the same shape as the rear of the intermediate block 28B. That is, the rear of the main body 92 has a rotating shaft 50, an upper first rear surface 51u, a lower first rear surface 51d, an upper second rear surface 52u, and a lower second rear surface 52d. These configurations have already been explained in the section on the intermediate block 28B, so a redundant explanation will be omitted here.
[0075] Furthermore, the tip block 28C, like the intermediate block 28B, is provided with three holes: one first hole 41 and two second holes 42. The first hole 41 passes through the axis Ax of the tip block 28C and forms the core material passage hole 31. The second holes 42 pass above and below the axis Ax, respectively, and form the wire passage holes 32.
[0076] As shown in Figure 8C, the first hole 41 has its rear end open at the rear end of the tip block 28C, and its front end is located within the front end 90 and closed. The first hole 41 also intersects the vertical through hole 93 midway along its longitudinal direction. The second hole 42 has its rear end open at the rear end of the tip block 28C, and its front end opens toward the vertical through hole 93. Therefore, the second hole 42 is in communication with the vertical through hole 93.
[0077] (4. Assembly) Next, the assembly procedure for the stylet 20 with the above configuration will be explained. First, in the first step, all blocks 28 are assembled. That is, the rotating shaft portion 50 of one block 28 is inserted from the side into the bearing portion 60 of one block 28 and engaged. This is done for the base block 28A, the multiple intermediate blocks 28B, and the tip block 28C, so that all blocks 28 are engaged with each other. In this state, all blocks 28 are prevented from coming off in the direction along the axis Ax, and twisting around the axis Ax is restricted, and the posture is stabilized.
[0078] In the second step, the core material 26 is inserted into the core material passage hole 31 and fixed in place. Specifically, the tip of the core material 26 is inserted forward from the opening at the rear part 81 of the base block 28A into the first hole 41 of the base block 28A (i.e., the core material passage hole 31). Then, with the front part of the second cap 35 at the base end of the core material 26 pressed into the first hole 41 of the base block 28A, the second cap 35 is welded to the base block 28A. With the core material 26 fixed in place, a gap C3 of a predetermined size is formed between the tip of the core material 26 and the tip of the core material passage hole 31 in the direction along the axis Ax.
[0079] In the third step, two wires 24 are inserted into and fixed in the wire passage holes 32. Specifically, the base end of one wire 24 is inserted through the upper opening of the vertical through hole 93 of the tip block 28C into the upper second hole 42 (i.e., the wire passage hole 32). Then, a portion of the first cap 33 at the tip of the wire 24 is press-fitted into the second hole 42, and in this state, the first cap 33 is welded to the tip block 28C. Similarly, the base end of the other wire 24 is inserted through the lower opening of the vertical through hole 93 of the tip block 28C into the lower second hole 42 (i.e., the wire passage hole 32). Then, a portion of the first cap 33 at the tip of the wire 24 is press-fitted into the second hole 42, and in this state, the first cap 33 is welded to the tip block 28C.
[0080] In the fourth step, the coil tube 41 is passed through the wire 24, and the tip of the coil tube 41 is fixed to the base block 28A. That is, at the end of the third step, the wire 24 has its first portion 241 and second portion 242 located inside the movable shaft portion 23, and its third portion 243 extending rearward from the movable shaft portion 23. The coil tube 41 is attached to the wire 24 by passing this third portion 243 through the coil tube 41. Then, the tip of the coil tube 41 is welded to the wall surface of the slit 82 of the base block 28A.
[0081] In the fifth step, the movable shaft portion 23 and the base shaft portion 22 are connected. Specifically, the two wires 24, which are inserted through the coil tube 41, are inserted into the internal space of the pipe member 37 and the base shaft portion 22. Then, the rear end of the base block 28A is fitted into the front end opening of the pipe member 37 and welded, and the rear end opening of the pipe member 37 is fitted into the front end of the base shaft portion 22 and bonded, so that the front end of the base shaft portion 22 and the rear end of the base block 28A are butted together inside the pipe member 37.
[0082] The base shaft portion 22 and the movable shaft portion 23, which are connected in this manner, are covered with a covering tube 38. As already described, the covering tube 38 has a predetermined length and covers the entire pipe member 37 on the base end side, covers a part of the base end side of the tip block 28C on the tip end side, and covers all the intermediate blocks 28B in between.
[0083] Here, the covering tube 38, in its unused state, has an inner diameter slightly smaller than the outer diameter of the block 28 and is also elastic. Therefore, when the covering tube 38 is placed over the movable shaft portion 23, the covering tube 38 makes tight contact with the outer surface of each block 28. As a result, displacement of adjacent blocks 28 in the left-right direction (displacement toward the direction in which the hinge portion 70 comes off) is prevented. In other words, each block 28 is held in place by the covering tube 38.
[0084] Furthermore, the front end of the pipe member 37 is positioned so as to abut from the rear against a step 81a at the boundary between the front portion 80 and the rear portion 81 of the base block 28A. This step 81a has a step dimension that is the same as or close to the wall thickness dimension of the pipe member 37. Therefore, when the pipe member 37 is fitted onto the base block 28A, the step difference between the outer surface of the pipe member 37 and the outer surface of the front portion 80 exposed from the pipe member 37 on the base block 28A is zero or a small value close to zero.
[0085] Furthermore, the front end of the covering tube 38 is positioned to abut from the rear against a step 91a at the boundary between the front end 90 and the reduced diameter portion 91 in the tip block 28C. This step 91a has a step dimension that is the same as or close to the wall thickness dimension of the covering tube 38. Therefore, when the covering tube 38 is fitted onto the tip block 28C, the step difference between the outer surface of the covering tube 38 and the outer surface of the front end 90 exposed from the covering tube 38 in the tip block 28C is zero or a small value close to zero.
[0086] (5. Stylet operation) The stylet 20 is assembled as described above. Figure 9A is an external view showing only the block 28 of the movable shaft portion 23 of the assembled stylet 20, which is in a straight line, and Figure 9B is an external view showing the movable shaft portion 23 of Figure 9A bent upward.
[0087] As shown in Figure 9A, the stylet 20, which consists of a base block 28A, a plurality of intermediate blocks 28B, and a tip block 28C, has adjacent blocks 28 connected to each other by a hinge portion 70 in which one rotating shaft portion 50 and the other bearing portion 60 engage. When the user is not operating the actuator 12 (see Figure 2), the movable shaft portion 23 maintains a straight shape due to the elastic force of the core material 26.
[0088] On the other hand, when the user operates the actuator 12 to pull, for example, the upper wire 24 backward, the movable shaft 23 bends upward, as shown in Figure 9B. The amount of displacement (bending) of the movable shaft 23 is proportional to the amount of operation of the actuator 12, but as already mentioned, the maximum displacement occurs when the opposing surfaces of adjacent blocks 28 are in contact. On the other hand, when the user reduces the amount of operation of the actuator 12, a restoring force acts on the movable shaft 23 to a straight state due to the elasticity of the core material 26, and the amount of displacement (bending) of the movable shaft 23 decreases by the amount of operation reduced. Then, when the user releases the operation of the actuator 12, the movable shaft 23 returns to its straight shape, which is the unoperated state, due to the elasticity of the core material 26 (see Figure 9A).
[0089] Furthermore, as shown in Figure 3, the base end of the core material 26 is located closer to the base than the connection position P1 at the base end, and the tip of the core material 26 is located closer to the tip than the connection position P2 at the tip end. Therefore, the core material 26 can provide posture holding force and posture restoring force to the hinge portion 70 between all blocks 28.
[0090] Furthermore, the stylet 20 of this disclosure has a configuration in which the first portion 241 and the third portion 243 of the wire 24, which pass through the base shaft portion 22, and the third portion 243, which passes through the movable shaft portion 23, are connected by a second portion 242 that extends diagonally with respect to the axis Ax, so that the radial positions of the first portion 241 and the third portion 243 are different.Therefore, the base shaft portion 22 has a high degree of freedom in selecting the inner diameter dimension, and preferred materials and configurations can be adopted according to the necessary conditions such as rigidity, weight, and cost.
[0091] On the other hand, since the wire 24 is inserted through the coil tube 41 from the first part 241 to the second part 242, even if the second part 242 is inclined, the sliding resistance when the wire 24 moves back and forth during operation can be reduced. Note that the tube through which the wire 24 passes is not limited to the coil tube 41; other configurations such as a normal tube with a flat curved surface may also be used. However, when the coil tube 41 is used, the contact with the wire 24 becomes a point contact, reducing the contact area, which is effective in reducing sliding resistance.
[0092] (6. Variant) The configuration of the stylet 20 described above is just one example of an intubation assist device according to this disclosure, and is not limited thereto. For example, although this embodiment shows an example with one core material 26, a configuration with two core materials is also possible. In this case, twisting of adjacent blocks 28 around the axis Ax can be further suppressed. Alternatively, the two core materials may be arranged parallel to each other to the left and right. In this case, the posture-holding force against the load from above and the load from below of the movable shaft portion 23 can be equalized. Similarly, the restoring force acting on the upward bending of the movable shaft portion 23 and the restoring force acting on the downward bending can be equalized.
[0093] Furthermore, in this embodiment, the base end of the core material 26 is fixed within the base block 28A via the second cap 35, but the embodiment is not limited to this. For example, the base end of the core material 26 may be extended further towards the base than the base block 28A, into the interior of the tip of the base shaft portion 22. Moreover, the base end of the core material 26 may be extended to a position that coincides with the base end of the pipe member 37 that fits onto the base shaft portion 22, or even further towards the base. This suppresses deformation such as bending of the tip of the base shaft portion 22, thereby preventing the adhesive between the base shaft portion 22 and the pipe member 37 from peeling off.
[0094] Furthermore, in this embodiment, the core material 26 is exemplified as having a constant diameter along its entire length, but it is not limited to such a configuration. For example, the core material 26 may have a configuration in which the diameter gradually decreases from the base end to the tip end, or in which the diameter varies depending on the position in the longitudinal direction. Also, the core material 26 is not limited to having a circular cross-sectional shape, but may have a polygonal shape such as a rectangle, or a cross-sectional shape such as an oval or elliptical shape. [Industrial applicability]
[0095] This disclosure can be applied to medical devices in which the tip portion can be bent by manual manipulation, and is particularly suitable for intubation assistance devices used to assist in inserting medical rods such as tracheal tubes into body cavities, such as stylets and bougies. [Explanation of symbols]
[0096] 20. Stylet (intubation support device) 21 Shaft 22 Base shaft section 23 Movable shaft section 24 wires 24A First wire 24B Second wire 26 Core material 28 blocks 28A Base block 28B Intermediate Block 28C Tip Block 31 Core material passage holes 32 Wire passage holes 34 Coil Tubes 50 Rotating shaft section 60 Bearing section 82 Slits 91 Reduced diameter part 93 Vertical through hole 241 Part 1 242 Part 2 243 Part 3
Claims
1. A shaft having multiple blocks aligned in the axial direction, and including a movable shaft portion that can bend in a first direction intersecting the axial direction due to the relative attitude displacement of two adjacent blocks, A wire is provided so as to penetrate the plurality of blocks in the axial direction and applies the axial force to bend the movable shaft portion, The plurality of blocks are provided so as to penetrate the axial direction, and a linear core material is provided to impart a posture-holding force to the movable shaft portion, A device to assist in the intubation of a medical rod.
2. One of the two adjacent blocks is provided with a pivot shaft portion extending in a second direction perpendicular to both the axial direction and the first direction, and the other block is provided with a bearing portion through which the pivot shaft portion is inserted. The pivot shaft portion is fitted into the bearing portion by sliding in the second direction, and a hinge portion is formed that prevents the axial direction from coming loose. The medical rod intubation assist device according to claim 1.
3. The movable shaft portion has a passage hole that passes through the axis of the movable shaft portion in the space where the core material is provided, The wire has a first wire and a second wire that are provided so as to sandwich the passage hole. The medical rod intubation assist device according to claim 1.
4. The movable shaft portion has a passage hole that extends in the axial direction and is a space in which the core material is provided, and the inner surface of the passage hole and the outer surface of the core material are configured to move relative to each other in the axial direction when the movable shaft portion is displaced in the first direction. A radial gap is provided between the inner surface of the passage hole and the outer surface of the core material. The medical rod intubation assist device according to claim 1.
5. The core material has one of its axial base and tip ends fixed to the shaft, while the other end is not fixed to the shaft. The medical rod intubation assist device according to claim 4.
6. The base end of the core material is located closer to the base than the space between the two adjacent blocks that are located closest to the base in the movable shaft portion, and the tip of the core material is located closer to the tip than the space between the two adjacent blocks that are located closest to the tip in the movable shaft portion. The medical rod intubation assist device according to claim 1.
7. It is equipped with a covering tube that covers the movable shaft portion and holds a plurality of the blocks, The medical rod intubation assist device according to claim 1.
8. The shaft has a resin tube-shaped base shaft portion that is located closer to the base end than the movable shaft portion and is coaxial with the movable shaft portion. The aforementioned wire is The first portion passing through the internal space of the base shaft portion, Continuing from the first portion, the second portion passes through the base end portion of the movable shaft and extends radially outward from the base end towards the tip, Continuing from the second portion, the movable shaft portion extends toward the tip and has a third portion located radially outward from the first portion, A tube is provided inside the shaft through which the first and second portions of the wire pass. The medical rod intubation assist device according to claim 1.
Citation Information
Patent Citations
intubation stylet
JP1995505317A