Inserter

The inserter's design with a groove and bending portion addresses the challenge of attaching and detaching elongated medical objects with curved tips and varying diameters, enabling multiple uses and smooth insertion into medical instruments.

JP2025176378APending Publication Date: 2025-12-04TERUMO KK
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Patent Information

Application Number
JP2024082488
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Filing Date
2024-05-21
Publication Date
2025-12-04

AI Technical Summary

Technical Problem

Existing inserters struggle to accommodate elongated medical objects with curved tips and varying diameters, leading to difficulty in attachment and detachment, and are often not reusable.

Method used

An inserter with a groove extending from the tip to the base, featuring a bending portion and a groove with varying gap widths, allowing multiple uses with elongated medical objects having curved shaping portions and varying diameters.

Benefits of technology

Enables repeated use of the inserter with elongated medical objects by minimizing interference and ensuring stable attachment and detachment, facilitating insertion into medical instruments.

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Abstract

To provide an inserter that can be used multiple times in a medical long body including a shape imparting part shaped so as to be curved in a distal end side, and a portion with an outer diameter that increases, in a proximal end side from the shape imparting part.SOLUTION: An inserter 10 includes: a distal end part 11 forming a distal end; and a bent part 12 bent in a proximal end side from the distal end part 11. The inserter 10 is formed with a groove 14 extending from the distal end of the distal end part 11, over the bent part 12, to the proximal end side, and capable of storing a medical long body.SELECTED DRAWING: Figure 1
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Description

[Technical Field]

[0001] The present invention relates to an inserter that assists in inserting an elongated medical object into another medical instrument. [Background technology]

[0002] In the treatment of blood vessels, procedures using long medical objects such as catheters and dilators are performed. When the tip of a dilator is curved, it is difficult to insert the tip of the dilator into a catheter. For this reason, an inserter is needed to straighten the tip of the dilator (see, for example, Patent Document 1). [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 4373083 specification Summary of the Invention [Problem to be solved by the invention]

[0004] After inserting an elongated medical object (e.g., a dilator) into a medical device (e.g., a catheter) via a cylindrical inserter, the inserter must be moved along the outer surface of the dilator to its proximal end in order to remove it from the dilator. However, if the dilator has a portion where the outer diameter increases along its longitudinal axis, it is difficult to move the inserter along the outer surface of the dilator. In contrast, peel-off inserters, which can be torn along their longitudinal axis to remove the inner member, can be used with dilators that have a portion where the outer diameter increases along their longitudinal axis, but once torn, they cannot be reused.

[0005] The present invention has been made to solve the above-mentioned problems, and aims to provide an inserter that can be used multiple times on a medical elongate body that has a shaping portion that is curved and shaped at the tip side and a portion whose outer diameter increases proximally from the shaping portion. [Means for solving the problem]

[0006] The above object can be achieved by the invention described in (1) below. (1) The inserter according to the present invention has a tip portion that forms the tip, and a bending portion that is bent at a position closer to the base end than the tip portion, and is characterized in that a groove that extends from the tip of the tip portion beyond the bending portion to the base end and is capable of accommodating a medical elongated body is formed. [Effects of the Invention]

[0007] The inserter described in (1) above can be used to attach and detach the elongated medical object to and from the groove from the side, and the bent portion makes it less likely that the proximal end of the inserter will interfere with the portion of the elongated medical object where the outer diameter increases. Therefore, the inserter can be used multiple times with an elongated medical object that has a curved shaping portion and a portion where the outer diameter increases proximally from the shaping portion.

[0008] (2) In the inserter described in (1) above, the groove may have a receiving portion with a larger gap width than the narrow portion, located closer to the bottom of the groove than the narrow portion, in a cross section perpendicular to the longitudinal axis. This allows the inserter to stably hold the elongated medical object pushed into the groove from the side beyond the narrow portion in the receiving portion.

[0009] (3) In the inserter described in (1) or (2) above, the groove may be located on the side that becomes convex when the bending portion bends. This makes it less likely that the portion of the inserter that is closer to the base end than the bending portion will interfere with the elongated medical object when the elongated medical object is pushed into the groove from the side. This makes it easier to attach and detach the elongated medical object to and from the inserter.

[0010] (4) In the inserter described in any one of (1) to (3) above, the distal end portion may have a tapered distal end portion whose outer diameter decreases toward the distal end, thereby facilitating insertion of the tapered distal end portion into another medical instrument. [Brief explanation of the drawings]

[0011] [Figure 1] FIG. 2 is a front view showing the inserter according to the embodiment. [Figure 2] FIG. 2 is a top view showing the inserter according to the embodiment. [Figure 3] FIG. 2 is a cross-sectional view taken along line AA in FIG. [Figure 4] 10A and 10B are cross-sectional views showing modified inserters, where FIG. 10A shows a first modified example and FIG. 10B shows a second modified example. [Figure 5] FIG. 1 is a front view showing a dilator, which is an example of a medical elongate body. [Figure 6] FIG. 10 is a front view illustrating a state in which the dilator is pushed into the groove of the inserter from the side. [Figure 7] 7 is a cross-sectional view taken along line BB in FIG. 6. [Figure 8] FIG. 10 is a front view illustrating a state in which the shape imparting portion of the dilator is linearly extended by the inserter. [Figure 9] FIG. 10 is a front view illustrating a state in which the tip of the dilator is inserted into the suction catheter via the inserter. [Figure 10] FIG. 10 is a front view illustrating the state in which the inserter has been removed from the suction catheter and the dilator. DETAILED DESCRIPTION OF THE INVENTION

[0012] Hereinafter, an embodiment of the present invention will be described with reference to the drawings. Note that the dimensional proportions in the drawings may be exaggerated for convenience of explanation and may differ from the actual proportions. In the following description, the side of the inserter that is inserted into another medical instrument will be referred to as the "distal side," and the opposite side will be referred to as the "proximal side."

[0013] The inserter 10 according to an embodiment of the present invention is configured so that a dilator 20 (elongated medical body) (see FIG. 5) having a curved, shaped shaping portion 38 and a portion (first tapered portion 32) whose outer diameter increases proximally from the shaping portion 38 can be inserted multiple times into another medical instrument, a suction catheter 40 (see FIGS. 9 and 10). When performing suction using the suction catheter 40 multiple times or when suctioning thrombi at multiple sites, the surgeon must insert the dilator 20 into the suction catheter 40 multiple times, allowing the inserter 10 to be used effectively.

[0014] 1 to 3, the inserter 10 is a long member extending from the distal end to the proximal end, and has a distal portion 11 forming the distal end, a bent portion 12 located proximally of the distal portion 11, and a proximal end 13 located proximally of the bent portion 12. A groove 14 extending from the distal end of the distal portion 11 to the proximal end of the proximal end 13 is formed on the side surface of the inserter 10.

[0015] The distal end portion 11 has a linearly extending axis. The distal end portion 11 has a tapered distal end portion 15 whose outer diameter decreases toward the distal end, and a constant outer diameter portion 16 whose outer diameter is approximately constant on the proximal side of the tapered distal end portion 15.

[0016] The bending portion 12 is a portion between the distal end portion 11 and the proximal end portion 13, where the axis is curved or bent at an angle θ. The angle θ is 5 to 60 degrees, more preferably 10 to 30 degrees, and even more preferably 15 to 25 degrees. If the angle θ is too small, the proximal end portion 13 of the inserter 10, which is closer to the proximal end than the bending portion 12, is likely to come into contact with and interfere with the dilator 20 when the dilator 20 is housed in the groove 14 of the distal end portion 11 of the inserter 10, thereby reducing operability when the surgeon grips the proximal end portion 13 and operates the inserter 10 with the dilator 20 housed in the groove 14 of the distal end portion 11 of the inserter 10.

[0017] The base end portion 13 is located closer to the base end than the bent portion 12 and has a linearly extending axis. Note that the axis of the base end portion 13 may not be linear but may be curved.

[0018] As shown in FIG. 3 , in a cross section perpendicular to the long axis, the groove 14 has an opening 19 in which a narrow width portion 17 having the smallest gap width A is formed, and a storage portion 18 formed at the bottom (rear side) of the groove 14 relative to the opening 19 and having a gap width B larger than that of the narrow width portion 17. The gap width A of the narrow width portion 17 is smaller than the outer diameter C of the suction catheter 40 stored in the groove 14. This prevents the suction catheter 40 stored in the groove 14 from unintentionally detaching from the inserter 10 through the narrow width portion 17. The gap width B of the storage portion 18, i.e., the inner diameter of the storage portion 18, is larger than the gap width A of the narrow width portion 17 and is also larger than the outer diameter C of the dilator 20. This allows the inserter 10 to slidably store the dilator 20 in the storage portion 18 of the groove 14. The difference between the inner diameter of the inserter 10 (gap width B of the housing portion 18) and the outer diameter C of the shape-imparting portion 38 of the dilator 20 is preferably 0.27 mm or less.

[0019] In this embodiment, the inserter 10 is formed in an arc shape with a central angle α in a cross section perpendicular to the major axis. The central angle α is 180 to 340 degrees, more preferably 200 to 300 degrees, and even more preferably 230 to 270 degrees.

[0020] 1, groove 14 is located on the side of bent portion 12 that becomes convex when bent (upper side of the paper in FIG. 1). Note that the position of groove 14 is not limited to the side of bent portion 12 that becomes convex when bent, and may be, for example, a position shifted by 90 degrees from the convex side (toward the rear or front of the paper in FIG. 1) or a position shifted by 180 degrees from the convex side (lower side of the paper in FIG. 1).

[0021] Furthermore, the shape of the opening 19 where the narrow portion 17 of the groove 14 is formed is not limited. For example, as in a first modified example shown in Fig. 4(A), the opening 19 may have a constant gap width A in the radial direction. Furthermore, as in a second modified example shown in Fig. 4(B), the opening 19 may be formed to have a flat surface 19A facing the opening direction.

[0022] The material of the inserter 10 is not particularly limited as long as it has a certain degree of strength and can be elastically deformed to change the gap width A of the opening 19. For example, various resin materials such as polyolefins such as polyethylene, polypropylene, and ethylene-propylene copolymers, polyvinyl chloride, polystyrene, polyamide, polycarbonate, and acrylic resins can be used. The material of the inserter 10 may also be a metal material.

[0023] Next, we will explain the dilator 20 (elongated medical body) whose insertion into the suction catheter 40 (medical instrument) is assisted by the inserter 10 according to this embodiment. As shown in Fig. 5, the dilator 20 has a tubular body 21 and a hub 22 fixed to the base of the tubular body 21. The tubular body 21 has an inner cavity 23 that runs through it in the longitudinal direction, and a tip opening 24 is formed at the tip end.

[0024] The tube body 21 has, from the tip side, a first thin diameter portion 31, a first tapered portion 32, a first thick diameter portion 33, a second tapered portion 34, a second thin diameter portion 35, a third tapered portion 36, and a second thick diameter portion 37.

[0025] The first narrow diameter section 31 is located on the distal end side of the tubular body 21 and is formed with a constant outer diameter in the longitudinal direction. The first narrow diameter section 31 has a so-called pigtail shape. The first narrow diameter section 31 has a shape imparting section 38 on the distal end side and a straight section 39 located on the proximal end side of the shape imparting section 38. The radius of curvature of the curved axis of the shape imparting section 38 is preferably 3 mm to 15 mm. The radius of curvature of the shape imparting section 38 may not be constant but may vary along the longitudinal axis. The straight section 39 has an axis that extends linearly. The first narrow diameter section 31 does not have to have the straight section 39.

[0026] The first tapered portion 32 is formed with an outer diameter that increases in a tapered manner from the base end of the first thin diameter portion 31 in the base end direction. The first thick diameter portion 33 is formed with a constant outer diameter from the base end of the first tapered portion 32 in the base end direction. The first thick diameter portion 33 has an axis that extends substantially linearly. The second tapered portion 34 is formed with an outer diameter that decreases in a tapered manner from the base end of the first thick diameter portion 33 in the base end direction.

[0027] The second small diameter portion 35 is formed with a constant outer diameter from the base end toward the base end of the second tapered portion 34. The second small diameter portion 35 has an axis that extends substantially linearly.

[0028] The third tapered portion 36 is formed with an outer diameter that increases in a tapered manner from the base end of the second thin diameter portion 35 toward the base end. The second thick diameter portion 37 is formed with a constant outer diameter from the base end of the third tapered portion 36 toward the base end. The second thick diameter portion 37 has an axis that extends substantially linearly.

[0029] The dilator 20 fills the space between the suction catheter 40 and the guidewire inserted into the lumen 23 of the dilator 20, increasing the rigidity of the catheter system including the suction catheter 40, the dilator 20, and the guidewire, and improving pushability. In addition, the dilator 20 has a second thin diameter section 35 that is thinner than the first thick diameter section 33 and the second thick diameter section 37, between the first thick diameter section 33 and the second thick diameter section 37, which are thick and difficult to bend, making it easier to bend, improving blood vessel selectivity and operability.

[0030] Next, a method for inserting the tip of the dilator 20 into the suction catheter 40 using the inserter 10 according to this embodiment will be described.

[0031] First, as shown in FIGS. 6 and 7 , the surgeon grasps the inserter 10 with one hand and the dilator 20 with the other hand, and pushes the straight portion 39 of the dilator 20, located between the shaping portion 38 and the first tapered portion 32, into the groove 14 of the inserter 10 from the side. At this time, although the outer diameter C of the dilator 20 is larger than the gap width A of the opening 19, the dilator 20 and the inserter 10 deform, allowing the dilator 20 to enter the accommodation portion 18 of the groove 14 of the inserter 10. At this time, it is preferable that the tip of the inserter 10 be located proximally of the shaping portion 38 of the dilator 20, and that the bent portion 12 of the inserter 10 be located distally of the first tapered portion 32 of the dilator 20. This allows the inserter 10 to smoothly accommodate the dilator 20 without coming into contact with the shaping portion 38 and the first tapered portion 32.

[0032] Next, as shown in Figure 8, the surgeon grasps the inserter 10 with one hand and the dilator 20 with the other hand and moves them toward the proximal end. As a result, the shape imparting portion 38 of the dilator 20, which is curved in a so-called pigtail shape, is accommodated in the distal end portion 11 of the inserter 10 and deformed into a straight line.

[0033] 9, the surgeon moves the dilator 20 together with the inserter 10 toward the distal end, and inserts the distal end of the inserter 10 into the suction catheter 40. The distal end of the inserter 10 is formed with a tapered distal end portion 15, allowing the surgeon to smoothly insert the distal end of the inserter 10 into the suction catheter 40.

[0034] Next, as shown in FIG. 10 , the surgeon moves the inserter 10 toward the proximal end, leaving the dilator 20 inside the suction catheter 40. Next, the surgeon moves the inserter 10 in a direction approximately perpendicular to the longitudinal direction, causing the dilator 20 to separate from the groove 14. At this time, although the outer diameter C of the dilator 20 is larger than the gap width A of the opening 19, the dilator 20 and the inserter 10 deform, allowing the dilator 20 to separate from the groove 14 of the inserter 10. Thereafter, the surgeon moves the dilator 20 further toward the distal end, causing it to pass through the suction catheter 40.

[0035] As described above, the inserter 10 according to this embodiment has a distal portion 11 forming the distal tip, a bent portion 12 bent proximally of the distal portion 11, and a groove 14 capable of accommodating an elongated medical object (dilator 20) that extends from the distal end of the distal portion 11 to the proximal side of the bent portion 12. This allows the inserter 10 to be used by attaching and detaching the elongated medical object to and from the groove 14 from the side, and the presence of the bent portion 12 makes it less likely that the proximal end 13 of the inserter 10 will interfere with a portion of the elongated medical object where the outer diameter increases. Therefore, the inserter 10 can be used multiple times with an elongated medical object that has a curved shaping portion 38 and a portion where the outer diameter increases proximally of the shaping portion 38.

[0036] Furthermore, in a cross section perpendicular to the long axis, the groove 14 has a storage portion 18 having a larger gap width B than the narrow width portion 17, which is located closer to the bottom of the groove 14 than the narrow width portion 17, which has the smallest gap width A. This allows the inserter 10 to stably hold the elongated medical object (dilator 20) pushed into the groove 14 from the side in the storage portion 18, beyond the narrow width portion 17.

[0037] Furthermore, the groove 14 is located on the side that becomes convex when the bending portion 12 is bent. As a result, when the elongated medical object (dilator 20) is pushed into the groove 14 from the side, the portion of the inserter 10 that is closer to the base end than the bending portion 12 is less likely to interfere with the elongated medical object. This makes it easy to attach and detach the elongated medical object to and from the inserter 10.

[0038] The distal end portion 11 also has a distal end tapered portion 15 whose outer diameter decreases toward the distal end, which makes it easy to insert the distal end tapered portion 15 into another medical instrument (suction catheter 40).

[0039] The present invention is not limited to the above-described embodiment, and various modifications can be made by those skilled in the art within the technical spirit of the present invention. For example, the medical elongate body is not limited to the dilator 20, but may be, for example, a catheter or a guidewire. Furthermore, the medical device is not limited to the suction catheter 40, but may be, for example, a catheter used for a purpose other than suction. [Explanation of symbols]

[0040] 10 Inserter 11 Tip 12 Bending section 13 Proximal end 14 groove 15 Tapered tip 16 Constant outer diameter part 17 Narrow width section 18 Storage section 19 Opening 20 Dilator (long medical body) 31 First tapered section 38 Shape imparting section 40 Suction catheter (medical device)

Claims

1. The needle has a tip portion that forms a tip end and a bent portion that is bent on the base end side of the tip portion, An inserter characterized in that a groove is formed that extends from the tip of the distal end portion, beyond the bent portion, to the base end side, and is capable of accommodating a medical elongate body.

2. The inserter according to claim 1, characterized in that the groove has a storage portion, the storage portion having a gap width larger than the narrow width portion, located closer to the bottom of the groove than the narrow width portion, which has the smallest gap width, in a cross section perpendicular to the major axis.

3. The inserter according to claim 1 or 2, wherein the groove is located on a side of the bent portion that becomes convex when bent.

4. 3. The inserter according to claim 1, wherein the tip portion has a tapered tip portion whose outer diameter decreases toward the tip.

Citation Information

Patent Citations

  • guide wire inserter

    JP4373083B2