Storage tool
The container with breakable fracture sections and gripping portions addresses the uncontrollability and damage issues of guidewires by enabling controlled, bundled removal through a side opening, ensuring sterility and protection.
Patent Information
- Application Number
- JP2024107216
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2024-07-03
- Publication Date
- 2026-01-16
AI Technical Summary
Guidewires become uncontrollable due to their long length and repulsive force, making them difficult to maintain in a sterile field and prone to damage from rubbing against the tubular housing, especially when inserted through arteries in the wrist.
A container with a spirally wound tubular body featuring breakable fracture sections and a separation section allows controlled removal of the guidewire without pulling it through the end opening, using gripping portions to facilitate handling and prevent damage.
The container enables easy handling and maintenance of guidewires in a sterile field, preventing damage by allowing removal through a side opening while bundled, thus enhancing control and reducing surface abrasion.
Smart Images

Figure 2026007415000001_ABST
Abstract
Description
[Technical Field]
[0001] The present invention relates to a container for an elongated medical device. [Background technology]
[0002] A guidewire is a device that is inserted into a blood vessel prior to a therapeutic device, such as a catheter or stent, for intravascular treatment in order to guide the device to a target site. Because guidewires are long, they are stored and transported in a container in which a long tubular body is wound in a spiral shape (see, for example, Patent Document 1). [Prior art documents] [Patent documents]
[0003] [Patent Document 1] Japanese Patent Application Publication No. 2019-037660 Summary of the Invention [Problem to be solved by the invention]
[0004] The guidewire is completely removed from the tubular housing to be immersed in saline or the like. However, the guidewire can become uncontrollable due to its long length and the repulsive force of the metal wire. This lack of control makes it difficult to keep the guidewire in the sterile field and can lead to it falling off the operating table. In particular, a guidewire inserted through an artery in the wrist is even more difficult to control because it is much longer than the patient's height.
[0005] Furthermore, the entire guidewire is pulled out from the end opening of the tubular body of the housing. At this time, the outer circumferential surface of the guidewire may rub against the end opening of the tubular body of the housing, potentially damaging the outer circumferential surface of the guidewire. Therefore, if the outer circumferential surface of the guidewire is provided with a hydrophilic coating, the hydrophilic coating may be damaged. Damage to the hydrophilic coating may reduce the ease of insertion and operability of the guidewire into a blood vessel.
[0006] The present invention has been made to solve the above-mentioned problems, and aims to provide a storage device that makes it easy to keep a long device being removed in a sterile field and that can prevent damage to the outer surface of the long device. [Means for solving the problem]
[0007] The above object can be achieved by the invention described in (1) below. (1) The container of the present invention is a container having a spirally wound tubular body capable of storing a long medical device, characterized in that the tubular body has a separation section defined by two breakable fracture sections provided along the entire length of the tubular body in a part of its circumference. [Effects of the Invention]
[0008] The container described in (1) above can form an opening along the longitudinal direction of the tubular body by breaking the breaking portion and removing the separation portion from the tubular body. This allows the surgeon to remove the long device while it is still wound and bundled through the opening formed in the tubular body. As a result, the surgeon can more easily handle the long device being removed, making it easier to keep the long device in the sterile field. Furthermore, there is no need to pull the long device out of the opening at the end of the tubular body in the longitudinal direction. This prevents the outer surface of the long device from rubbing against the edge of the opening at the end of the tubular body and causing damage.
[0009] (2) In the container described in (1) above, the separation part may have a grip part at at least one end in the longitudinal direction of the tubular body, which makes it easier for an operator to recognize the position of the separation part and allows the operator to easily remove the separation part from the tubular body by gripping the grip part with their fingers.
[0010] (3) In the container described in (2) above, the gripping portion may be formed to protrude radially outward from the outer peripheral surface of the separation portion, making it easier for the surgeon to recognize the position of the separation portion and to transmit force to the separation portion.
[0011] (4) In the container described in (2) above, the gripping portion may be formed at at least one end of the tube in the longitudinal direction so as to protrude in the longitudinal direction. This prevents the gripping portion from protruding from the outer circumferential surface of the wound tube. This allows the container to have the gripping portion without increasing its thickness.
[0012] (5) In the container described in (2) above, the gripping portion may be formed between two notches located on extensions of the two fractured portions at at least one end of the tubular body in the longitudinal direction. This allows the container to have a gripping portion without increasing its thickness. Furthermore, since the notches can be formed by processing a portion of the fractured portion during manufacturing, manufacturing is easy.
[0013] (6) The container according to any one of (1) to (5) above may have a clip with at least two recesses into which the spirally wound tubular body is fitted, and the width between the two breaking portions located at the portion of the tubular body fitted into the recesses may be equal to or less than the width of the entrance of the recesses. This allows the surgeon to remove the separation portion from the entrance of the recess while maintaining the tubular body in a spirally wound state with the clip. Therefore, the container allows the long device to be removed from the opening formed in the tubular body while still bundled in a wound state.
[0014] (7) In the container according to any one of (1) to (6) above, the separation section may be formed on an out-of-plane side of the surface on which the tubular body is spirally wound. This allows an operator to remove the separation section from the spirally wound tubular body and take out the long devices in a bundle while still in a wound state through an opening formed in the tubular body.
[0015] (8) In the container according to any one of (1) to (7) above, the width between the two breaking portions in the circumferential direction of the tubular body may be repeatedly increased and decreased along the longitudinal direction of the tubular body, thereby enabling the surgeon to grasp the long device from the wider opening of the tubular body after removing the separation portion, and gradually remove the long device while preventing the long device from jumping out all at once to the narrower opening. [Brief explanation of the drawings]
[0016] [Figure 1] FIG. 1 is a front view showing a container according to a first embodiment. [Figure 2] FIG. 2 is a cross-sectional view taken along line AA in FIG. [Figure 3] 1A and 1B are front views showing the tube body, in which FIG. 1A shows the state before the separation section is separated, and FIG. 1B shows the state after part of the separation section has been separated. [Figure 4] 10A to 10D are front views showing modified examples of the tube body, where (A) shows a first modified example, (B) shows a second modified example, (C) shows a third modified example, and (D) shows a fourth modified example. [Figure 5] FIG. 10 is a front view showing a fifth modified example of the tube body. [Figure 6] 10A and 10B are front views showing a sixth modified example of the tubular body, in which (A) shows the state before the removed portion is removed, and (B) shows the state after the removed portion is removed. DETAILED DESCRIPTION OF THE INVENTION
[0017] Hereinafter, embodiments of the present invention will be described with reference to the drawings. Note that the dimensional proportions in the drawings may be exaggerated for the sake of explanation and may differ from the actual proportions.
[0018] As shown in FIG. 1, a container 10 according to this embodiment is used to store and transport a long medical device.
[0019] An example of the long medical device accommodated in the housing 10 is a guidewire 100. The guidewire 100 may be in a form in which a metal core wire is entirely coated with a highly flexible resin such as urethane, or in a form in which the base end of the core wire is coated with a fluorine-based resin such as polytetrafluoroethylene and the tip end has a coil formed by winding a metal wire. The metal forming the core wire is made of a superelastic alloy such as a nickel-titanium alloy, stainless steel, or the like. The outer circumferential surface of the guidewire 100 is provided with a hydrophilic coating. The long medical device accommodated in the housing 10 is not limited to the guidewire 100 and may be, for example, a catheter.
[0020] As shown in Figures 1 and 2, the storage device 10 includes a spirally wound resin tubular body 20 that stores the guide wire 100, an inserter 50 connected to the tubular body 20, at least one clip 60 that maintains the wound shape of the tubular body 20, and a packaging bag 70.
[0021] The inserter 50 is a member that assists in the insertion of the guidewire 100 into the catheter. The inserter 50 is connected to one end of the tubular body 20 in the longitudinal direction. The inserter 50 is a tubular member made of resin that tapers in diameter toward the tip. Note that the container 10 does not necessarily have to have the inserter 50.
[0022] Each clip 60 is a resin member having a shape in which a plurality of recesses 61, into which the tube 20 fits, are arranged in parallel. By fitting the tube 20 into the recesses 61, the clips 60 fix the relative positions of adjacent portions of the tube 20, helping to maintain the wound shape of the tube 20. One or more clips 60 are provided along the winding direction of the tube 20.
[0023] The packaging bag 70 is a flexible, transparent resin bag that packs and seals the tubular body 20, the inserter 50, the clip 60, and the guidewire 100 together.
[0024] The tubular body 20 is wound so as to compactly accommodate the long guidewire 100 and protects the accommodated guidewire 100 from bending and external impact. The tubular body 20 has a first end opening 21 located at one end in the longitudinal direction of the tubular body 20 and a second end opening 22 located at the other end. Therefore, when using the guidewire 100, the guidewire 100 can be primed by passing physiological saline into the tubular body 20 from the first end opening 21 or the second end opening 22.
[0025] The length of the tube 20 in the longitudinal direction is not particularly limited, but is 150 mm to 500 mm. The inner diameter of the tube 20 is not particularly limited, but is 3 mm. The outer diameter of the tube 20 is not particularly limited, but is 4 mm.
[0026] The tube 20 has, in a portion of its circumferential direction, two breakable breaking portions 23 extending from the first end opening 21 to the second end opening 22, a separation portion 24 defined between the two breaking portions 23, and a tube main portion 25 provided in a different range in the circumferential direction from the separation portion 24. When fixed to the clip 60, the two breaking portions 23 and the separation portion 24 are located on the inlet side of the recess 61 of the clip 60. Furthermore, the two breaking portions 23 and the separation portion 24 are formed on the side of the tube 20 that is away from the plane of the spiral winding in an out-of-plane direction.
[0027] Each breaking portion 23 is formed parallel to the longitudinal axis of the tubular body 20. Therefore, the width W1 between the two breaking portions 23 is constant along the longitudinal axis. However, the width W1 between the two breaking portions 23 does not have to be constant along the longitudinal axis. The breaking portions 23 are, for example, perforations or grooves. The perforations are a structure in which a plurality of through-holes are arranged in a row penetrating the tubular body 20 in the thickness direction. The width W1 between the two breaking portions 23 is larger than the diameter D1 of the guidewire 100 housed in the tubular body 20 and smaller than the diameter D2 of the tubular body 20. This allows the guidewire 100 to be removed from the side opening 40 formed after the breaking portions 23 are broken and the separation portion 24 is separated from the main tubular body portion 25. The width W1 between the two breaking portions 23 is equal to or smaller than the width W0 of the entrance of the recess 61 of the clip 60 to which the tubular body 20 is fitted.
[0028] Separation section 24 is formed to have a size less than half, preferably about 1 / 4, the circumferential length of tubular body 20 in a cross section perpendicular to the longitudinal axis direction of tubular body 20. Main tubular section 25 is formed to have a size more than half, preferably about 3 / 4, the circumferential length of tubular body 20 in a cross section perpendicular to the longitudinal axis direction of tubular body 20. This allows main tubular section 25 to stably hold guidewire 100 inside, even after separation section 24 is separated.
[0029] The separation portion 24 has a grip portion 26 at one end in the longitudinal direction of the tubular body 20, which can be easily gripped by the surgeon. The grip portion 26 protrudes radially outward from the outer peripheral surface of the tubular body 20. The radial thickness of the grip portion 26 is, for example, approximately 3 mm. The width of the grip portion 26 in the circumferential direction of the tubular body 20 is not particularly limited, but is preferably approximately equal to the width of the outer peripheral surface of the separation portion 24. By having the grip portion 26 in the separation portion 24 of the container 10, the surgeon can easily separate the separation portion 24 from the tubular body main portion 25 by grasping the grip portion 26 with their fingers.
[0030] Next, how to use the container 10 will be described. One end of the tubular body 20 in the longitudinal direction is inserted into and connected to the inserter 50. A guidewire 100 is housed in the tubular body 20, and the tip of the guidewire 100 is inserted into the inserter 50. The tubular body 20, clip 60, inserter 50, and guidewire 100 housed in the tubular body 20 are packaged in a packaging bag 70.
[0031] Before using the guidewire 100, the surgeon takes out the tubular body 20, to which the clip 60 and the inserter 50 are connected, from the packaging bag 70, and removes the inserter 50 from the tubular body 20. Next, the surgeon injects saline into the tubular body 20 from the first end opening 21 or the second end opening 22 to prime the guidewire 100 inside the tubular body 20.
[0032] Next, as shown in FIG. 3(B), the surgeon grasps the gripping portion 26 located at the end of the separation portion 24 and breaks the breaking portion 23 along the longitudinal direction of the tubular body 20. This separates the separation portion 24 from the main tubular body portion 25, forming a side opening 40 in the tubular body 20. The surgeon can remove the guidewire 100 from the side opening 40 in its wound and bundled state without pulling it out of the first end opening 21 or the second end opening 22 of the tubular body 20, making it easier to control the guidewire 100. This prevents the guidewire 100 from falling off the operating table. When removing the guidewire 100 from the side opening 40, the surgeon may invert the main tubular body portion 25 so that the side opening 40 faces downward. The two breaking portions 23 and the separation portion 24 are located on the entrance side of the recess 61 of the clip 60 and are formed on the side away from the plane of the spiral winding of the tubular body 20 in an out-of-plane direction. This allows the surgeon to easily separate the separation portion 24 from the main tubular portion 25 and remove the guidewire 100 from the side opening 40.
[0033] As described above, the housing 10 according to this embodiment includes a spirally wound tubular body 20 capable of housing a long medical device (guidewire 100). The tubular body 20 has a separation section 24 defined by two breakable fracture sections 23 provided along the entire length of the tubular body 20 in a portion of its circumference. This allows the housing 10 to form an opening (side opening 40) along the longitudinal direction of the tubular body 20 by breaking the fracture sections 23 and removing the separation section 24 from the tubular body 20. This allows the surgeon to remove the long device in a bundled, wound state through the opening formed in the tubular body 20. This allows the surgeon to more easily control the long device being removed, making it easier to keep the long device in the sterile field. Furthermore, this eliminates the need to pull out the long device from the openings at the longitudinal ends of the tubular body 20 (first end opening 21 and second end opening 22). Therefore, it is possible to prevent the outer peripheral surface of the long device from rubbing against the edge of the opening at the end of the tube body 20 and being damaged.
[0034] Separation unit 24 may also have a gripping portion 26 at at least one end in the longitudinal direction of tubular body 20. This makes it easier for the surgeon to recognize the position of separation unit 24, and by gripping gripping portion 26 with the fingers, separation unit 24 can be easily removed from tubular body 20.
[0035] Furthermore, the gripping portion 26 is formed to protrude radially outward from the outer peripheral surface of the separation portion 24. This makes it easier for the surgeon to recognize the position of the separation portion 24 and to transmit force to the separation portion 24.
[0036] Furthermore, the container 10 has a clip 60 with at least two recesses 61 into which the spirally wound tubular body 20 fits, and the width W1 between the two breaking portions 23 located at the portion of the tubular body 20 that fits into the recesses 61 is equal to or less than the width W0 of the entrance to the recesses 61. This allows the surgeon to remove the separation portion 24 from the entrance to the recesses 61 while maintaining the tubular body 20 in a spirally wound state using the clip 60. Therefore, the container 10 allows the long device to be removed from the opening formed in the tubular body 20 while still bundled in a wound state.
[0037] Separation section 24 is formed on the out-of-plane side (the front side in the plane of FIG. 1 ) of the surface on which tubular body 20 is wound in a spiral shape. This allows long devices to be taken out of the spirally wound tubular body 20 while still bundled in a wound state through an opening formed in tubular body 20 by removing separation section 24.
[0038] 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 concept of the present invention.
[0039] For example, as in a first modified example shown in Fig. 4(A), the separation part 24 may have gripping parts 26 at both ends in the longitudinal direction of the tubular body 20. This allows the container 10 to separate the separation part 24 in either a clockwise or counterclockwise direction, improving workability.
[0040] 4(B), gripping portion 26 may be formed to protrude in the longitudinal direction from at least one end of tubular body 20 in the longitudinal direction. This prevents gripping portion 26 from protruding from the outer circumferential surface of wound tubular body 20. Therefore, container 10 can be provided with gripping portion 26 without increasing its thickness.
[0041] 4(C), grip portion 26 may be formed between two notches 27 located on an extension of breaking portion 23 at at least one end of tubular body 20 in the longitudinal direction. Notch 27 is formed to extend from the end face of tubular body 20 in the longitudinal direction beyond the perforated through-hole that forms breaking portion 23. This allows container 10 to be provided with grip portion 26 without increasing its thickness. Furthermore, notch 27 can be formed by processing a portion of breaking portion 23 during manufacturing, making manufacturing easier.
[0042] 4(D), the separating section 24 may have a gripping section 26 formed by cutting open a portion of the tube from which the tube 20 is made, at least at one end in the longitudinal direction of the tube 20. The width of the gripping section 26 is formed to be larger than the width W1 between the two breaking sections 23, and may also be formed to be larger than the outer diameter D2 of the tube 20. This allows the area that can be gripped by the gripping section 26 of the container 10 to be increased, improving operability. Furthermore, since the separating section 24 can be formed by cutting open a portion of the tube from which the tube 20 is made, it is easy to manufacture.
[0043] 5, the width W1 between the two breaking portions 23 in the circumferential direction of the tubular body 20 may be repeatedly increased and decreased along the longitudinal direction of the tubular body 20. This allows the surgeon to grasp the guidewire 100 from the wider portion of the side opening 40 of the tubular body 20 after removing the separation portion 24, and to remove the guidewire 100 in stages while preventing the guidewire 100 from jumping out all at once due to the narrower portion of the side opening 40.
[0044] The two breaking portions 23 are formed in a symmetrical wave shape. The minimum width W2 between the two breaking portions 23 is greater than the diameter D1 of the guidewire 100 so that the guidewire 100 can be removed from the side opening 40 after the separation portion 24 has been removed from the tubular body 20. The minimum width W2 between the two breaking portions 23 may be smaller than the diameter D2 of the tubular body 20, and the maximum width W3 between the two breaking portions 23 may be approximately the diameter D2 of the tubular body 20. Since the minimum width W2 between the two breaking portions 23 is smaller than the diameter D2 of the tubular body 20, the housing 10 can prevent the guidewire 100 from accidentally popping out of the side opening 40 after the separation portion 24 has been removed. Furthermore, the clip 60 is preferably fitted into the tubular body 20 at the position of the minimum width W2 of the breaking portion 23. This allows the surgeon to easily separate the separation section 24 from the main tubular body section 25 and remove the guidewire 100 from the side opening 40. By adjusting the position of the tubular body 20 relative to the clip 60, the surgeon can align the positions of the maximum widths W3 of the multiple tubular bodies 20 aligned radially from the winding center of the tubular body 20 at any position in the radial direction. As a result, when the separation section 24 is removed, the side openings 40 are formed so that the wider portions are aligned radially from the winding center of the tubular body 20. The surgeon can grasp and remove the guidewire 100 in a bundled, wound state from the position where the wider side openings 40 are aligned radially. Furthermore, by adjusting the position of the tubular body 20 relative to the clip 60, the surgeon can align the positions of the minimum widths W2 of the multiple tubular bodies 20 aligned radially from the winding center of the tubular body 20 with the position where the clip 60 fits. This prevents the clip 60 from partially covering the side opening 40 and hindering removal of the guidewire 100. In order to allow the surgeon to adjust the position of the tubular body 20 relative to the clip 60, it is preferable that the length L of one unit by which the width between the two breaking portions 23 increases or decreases is shorter than the distance between adjacent clips 60.
[0045] Furthermore, the two breaking portions 23 sandwiching the separation portion 24 may be wavy and generally parallel to each other. In this case, the separation portion 24 is also formed in a generally wavy shape.
[0046] Furthermore, the two breaking portions 23 sandwiching the separation portion 24 may be inclined with respect to the longitudinal axis of the tubular body 20. In this case, the guidewire 100 is prevented from jumping out of the side opening 40 all at once.
[0047] The surface of the gripping portion 26 may be processed to increase the contact area with the operator's fingers, such as by frosting or sandblasting to form a finely uneven surface.
[0048] 6(A), the main tubular portion 25 may have a plurality of removable portions 29 in a part of its longitudinal direction, sandwiched between two breakable second breaking portions 28. The plurality of removable portions 29 are arranged at each of a plurality of positions aligned radially from the center of winding of the wound main tubular portion 25. The second breaking portions 28 are, for example, perforations or grooves, similar to the breaking portions 23.
[0049] When removing the guidewire 100 from the container 10, the surgeon separates the separation portion 24 from the main tubular portion 25, and then breaks the multiple second breaking portions 28 of the main tubular portion 25, as shown in FIG. 6(B). This allows the surgeon to remove all of the removal portions 29 that are aligned radially from the center of winding. This allows the surgeon to grasp the guidewire 100 exposed from the main tubular portion 25 at the position where the removal portions 29 have been removed, while still bundled in its wound state, and remove it from the side opening 40. [Explanation of symbols]
[0050] 10 Storage equipment 20 Body 21 First end opening 22 Second end opening 23 Breaking part 24 Separation section 25 Main tube section 26 Gripping part 27 Cut 28 Second break 29 Removal part 40 Side opening 50 Inserter 60 clips 70 packaging bags 100 Guidewire (long device)
Claims
1. A container having a spirally wound tubular body capable of accommodating a long medical device, A container characterized in that the tubular body has a separation portion at a portion of its circumference defined by two breakable breaking portions provided over the entire length of the tubular body.
2. 2. The container according to claim 1, wherein the separating portion has a grip portion at least at one end in the longitudinal direction of the tubular body.
3. The container according to claim 2 , wherein the gripping portion is formed so as to protrude radially outward from the outer peripheral surface of the separating portion.
4. 3. The container according to claim 2, wherein the gripping portion is formed so as to protrude in the longitudinal direction from at least one end of the tubular body in the longitudinal direction.
5. 3. The container according to claim 2, wherein the gripping portion is formed between two notches located on extensions of the two breaking portions at at least one end of the tubular body in the longitudinal direction.
6. a clip having at least two recesses into which the spirally wound tube fits; 3. The container according to claim 1, wherein the width between the two breaks located at the portion of the pipe fitted into the recess is equal to or less than the width of the entrance of the recess.
7. 3. The container according to claim 1, wherein the separating portion is formed on an outward side of the surface on which the tube is spirally wound.
8. 3. The container according to claim 1, wherein the width between the two breaks in the circumferential direction of the tube repeatedly increases and decreases along the longitudinal direction of the tube.
Citation Information
Patent Citations
Package of medical device
JP2019037660A