Insertion device and gastrostomy catheter kit for gastrostomy catheters
The insertion jig with a detachable outer and inner tube system and locking mechanism addresses structural limitations in gastrostomy catheter tools, facilitating controlled expansion and stable placement, thus simplifying the indwelling process.
Patent Information
- Application Number
- JP2022046731
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2021-03-24
- Filing Date
- 2022-03-23
- Publication Date
- 2026-07-13
- Estimated Expiration
- 2042-03-23
AI Technical Summary
Existing gastrostomy catheter insertion tools face challenges in efficiently performing indwelling operations due to structural limitations.
An insertion jig with a detachable outer and inner tube system, featuring a pressing portion, locking member, and a guide wire mechanism that facilitates controlled expansion of the bumper within the stomach, ensuring precise placement of the gastrostomy catheter.
Enables easy and stable insertion of the gastrostomy catheter by restricting unintended movement and enhancing control during the indwelling process, thereby simplifying the procedure.
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Abstract
Description
Technical Field
[0001] The present invention relates to an insertion tool for a gastrostomy catheter and a gastrostomy catheter kit.
Background Art
[0002] As an insertion tool for a gastrostomy catheter used for indwelling a gastrostomy catheter, for example, there is one described in Patent Document 1. The insertion tool for a gastrostomy catheter of Patent Document 1 is an insertion tool used for inserting and indwelling a gastrostomy catheter having a shaft provided with a lumen, a bumper provided at the lower end of the shaft and expanding in the stomach, and a capsule cover for maintaining the bumper in a contracted state. It includes a cylindrical outer tube portion (described as an outer jacket portion in the same document) and an inner tube portion (described as an inner insertion portion in the same document) that is inserted into the outer tube portion so as to be able to move forward and backward. One of the outer tube portion and the capsule cover has a locking portion that locks to the other, and when the inner tube portion is passed through the outer tube portion and advanced, the locking by the locking portion is released.
Prior Art Documents
Patent Documents
[0003]
Patent Document 1
Summary of the Invention
Problems to be Solved by the Invention
[0004] According to the study of the inventor of the present application, the insertion tool for a gastrostomy catheter of Citation Document 1 still has room for improvement in the structure for performing the indwelling operation of the gastrostomy catheter as intended.
[0005] The present invention has been made in view of the above problems, and provides an insertion tool for a gastrostomy catheter and a gastrostomy catheter kit that can easily perform the indwelling operation of the gastrostomy catheter as intended.
Means for Solving the Problems
[0006] According to the present invention, an insertion jig is used for inserting and placing a gastrostomy catheter, which has a shaft with a lumen, a bumper provided at the lower end of the shaft that expands in the stomach, and a capsule cover that maintains the bumper in a contracted state, through a fistula. An outer tube portion having a connecting portion that is detachably connected to the upper end of the shaft, An inner tube portion is inserted into the lumen so as to be able to insert a guide wire and slide vertically relative to the outer tube portion, Equipped with, The upper end of the inner tube section is formed with a pressing portion that is pressed downward by the user. The pressing force applied to the pressing portion causes the inner tube portion to be pushed downward relative to the outer tube portion, thereby causing the lower end of the inner tube portion to press the capsule cover downward, detaching the capsule cover from the bumper and expanding the bumper. The lumen of the inner tube portion is open at the upper end surface of the pressing portion. The insertion jig further includes a locking member that is detachably attached to the outer tube portion and the inner tube portion, The locking member, when attached to the outer tube and the inner tube, maintains a state in which the vertical movement of the inner tube relative to the outer tube is restricted, thereby providing an insertion jig for a gastrostomy catheter.
[0007] Furthermore, the present invention provides a gastrostomy catheter kit comprising the insertion jig for a gastrostomy catheter of the present invention and the gastrostomy catheter. [Effects of the Invention]
[0008] According to the present invention, it becomes possible to easily perform the intended procedure of inserting a gastrostomy catheter. [Brief explanation of the drawing]
[0009] [Figure 1]This is a perspective view of a gastrostomy catheter kit according to an embodiment. [Figure 2] Figures 2(a) and 2(b) are longitudinal cross-sectional views of a gastrostomy catheter kit according to an embodiment. [Figure 3] This is a front view of an insertion jig for a gastrostomy catheter according to an embodiment. [Figure 4] This is a plan view of an insertion jig for a gastrostomy catheter according to an embodiment. [Figure 5] Figures 5(a), 5(b), 5(c), and 5(d) show the locking member in the embodiment, of which Figure 5(a) is a plan view, Figure 5(b) is a side view, Figure 5(c) shows the locking member inserted into the tubular body, and Figure 5(d) shows the locking member removed from the tubular body. [Figure 6] Figures 6(a) and 6(b) are side views showing the connecting portion of the insertion jig and the connected portion of the gastrostomy catheter and their surrounding structures in the embodiment. Figure 6(a) shows the state where the claw portion is located at the other end of the recess, and Figure 6(b) shows the state where the connecting portion is rotated relative to the connected portion from the state shown in Figure 6(a). [Figure 7] Figures 7(a) and 7(b) are diagrams illustrating the operation of the gastrostomy catheter kit according to the embodiment. Figure 7(a) shows the gastrostomy catheter kit inserted into the fistula, and Figure 7(b) shows the locking member removed from the tubular body. [Figure 8] Figures 8(a) and 8(b) illustrate the operation of the gastrostomy catheter kit according to the embodiment. Figure 8(a) shows the inner tube being pushed downward relative to the outer tube, and Figure 8(b) shows the insertion jig for the gastrostomy catheter being removed from the gastrostomy catheter. [Figure 9] This is a bottom view of the capsule cover in a modified example 1 of the embodiment. [Figure 10] Figure 10(a) is a cross-sectional view along line AA shown in Figure 9, and Figure 10(b) is a side view of the capsule cover in modified example 1 of the embodiment. [Figure 11]It is a longitudinal sectional view showing a state where the capsule cover in Modification Example 1 of the embodiment is attached to the bumper. [Figure 12] It is a bottom view of the capsule cover in Modification Example 2 of the embodiment. [Figure 13] FIG. 13(a) is a cross-sectional view taken along the line A-A shown in FIG. 12, and FIG. 13(b) is a side view of the capsule cover in Modification Example 2 of the embodiment. [Figure 14] It is a longitudinal sectional view showing a state where the capsule cover in Modification Example 2 of the embodiment is attached to the bumper. [Figure 15] It is a plan view of the capsule cover in Modification Example 2 of the embodiment.
Mode for Carrying Out the Invention
[0010] Hereinafter, embodiments of the present invention will be described with reference to FIGS. 1 to 8(b). In all the drawings, the same reference numerals are given to the same components, and the description will be omitted as appropriate. Further, FIG. 2(a) is a cross-sectional view taken along the line A-A shown in FIG. 4, and FIG. 2(b) is a cross-sectional view taken along the line B-B shown in FIG. 4. Further, FIGS. 7(a) to 8(b) are cross-sectional views at positions corresponding to the line A-A shown in FIG. 4. Moreover, various components of the gastrostomy catheter kit 300 of the present invention do not necessarily exist independently. It is acceptable that a plurality of components are formed as one member, one component is formed of a plurality of members, one component is a part of another component, and a part of one component overlaps with a part of another component. In the following description, it is assumed that the downward direction in FIGS. 2(a) and 2(b) is downward and the upward direction is upward. Also, the axial direction of the inner tube portion 30 may be simply referred to as the axial direction, and the radial direction of the inner tube portion 30 may be simply referred to as the radial direction. Further, the circumferential direction of the inner tube portion 30 may be simply referred to as the circumferential direction.
[0011] As shown in FIGS. 1, 2(a) and 2(b), an insertion jig for a gastrostomy catheter according to this embodiment (hereinafter, the insertion jig 100) includes a shaft 210 provided with a lumen 211, a bumper 250 provided at the lower end of the shaft 210 and expanding in the stomach, and a capsule cover 260 (see FIG. 7(a)) for maintaining the bumper 250 in a contracted state. The insertion jig is used to insert and留置 a gastrostomy catheter 200 through a fistula hole 430 (see FIG. 7(a) etc.). The insertion jig has an outer tube portion 20 having a connecting portion 40 detachably connected to the upper end portion of the shaft 210, and an inner tube portion 30 that is inserted through the lumen of the outer tube portion 20 and is slidable up and down with respect to the outer tube portion 20. At the upper end portion of the inner tube portion 30, a pressing portion 38 that is pressed downward by a user is formed. By pressing on the pressing portion 38, the inner tube portion 30 is relatively pushed downward with respect to the outer tube portion 20 (hereinafter, the pushing operation). As a result, the lower end portion of the inner tube portion 30 presses the capsule cover 260 downward, detaching the capsule cover 260 from the bumper 250 and expanding the bumper 250. The lumen of the inner tube portion 30 opens at the upper end surface of the pressing portion 38 (hereinafter, the opening 39). The insertion jig also further includes a lock member 60 detachably attached to the outer tube portion 20 and the inner tube portion 30. When the lock member 60 is attached to the outer tube portion 20 and the inner tube portion 30, the vertical movement of the inner tube portion 30 with respect to the outer tube portion 20 is maintained in a restricted state.
[0012] As shown in FIG. 7(a), when留置 the gastrostomy catheter 200, the guide wire <500> is inserted through the lumen of the inner tube portion 30, and the insertion jig 100 is inserted into the fistula hole 430 along the guide wire <500>. In FIGS. 7(a) to 8(a), the guide wire <500> is shown by a two-dot chain line.
[0013] According to this embodiment, when the lock member 60 is attached to the outer tube portion 20 and the inner tube portion 30, the vertical movement of the inner tube portion 30 with respect to the outer tube portion 20 is maintained in a restricted state. This prevents the inner tube 30 from unintentionally moving relative to the outer tube 20, and makes it easier to push the inner tube 30 downward relative to the outer tube 20 at the desired timing. Furthermore, according to this embodiment, the lumen of the inner tube portion 30 is open at the upper end surface of the pressing portion 38. As a result, when the guide wire 500 is inserted into the lumen of the inner tube 30, the end of the guide wire 500 is led out from the opening 39 on the upper end surface of the pressing portion 38. Therefore, when inserting the 200 towards the placement position along the 500, the guide wire 500 led out from the opening 39 can effectively hinder the pushing operation. Thus, it is possible to prevent the user from unintentionally pressing the pressing portion 38 at a stage prior to performing the pushing operation. Thus, according to this embodiment, it becomes possible to easily perform the intended placement of the gastrostomy catheter 200.
[0014] The gastrostomy catheter kit 300 according to this embodiment comprises an insertion jig 100 for a gastrostomy catheter and a gastrostomy catheter 200.
[0015] As shown in Figures 1 and 3, the outer tube portion 20 is formed in a cylindrical shape with the vertical direction as its axial direction. A finger rest portion 25 is formed at the upper end of the outer tube portion 20, where the user's fingers can be placed. The finger rest portion 25 is formed as a flat plate that protrudes radially outward from the outer circumferential surface of the upper end of the outer tube portion 20, and its surface is perpendicular to the axial direction. The planar shape of the finger rest portion 25 is, for example, approximately circular.
[0016] Furthermore, a connecting portion 40 is formed at the lower end of the outer tube portion 20, which is detachably hooked onto the connected portion 230. As shown in Figure 2(b), the connecting portion 40 includes, for example, a pair of protruding portions 42 extending laterally from the outer tube portion 20, a pair of downwardly protruding portions 44 each protruding downward from the tips of the pair of protruding portions 42, and a pair of claw portions 46 each protruding radially inward from the lower ends of the pair of downwardly protruding portions 44. Here, "later" means the direction perpendicular to the axial direction, i.e., the radial direction. In this embodiment, the pair of protruding portions 42 are positioned at different locations relative to each other, for example, around the axis of the outer tube portion 20. More specifically, for example, they are positioned 180 degrees rotationally symmetrical with respect to the axis of the outer tube portion 20. Similarly, the pair of downward projections 44 are positioned 180 degrees rotationally symmetrical with respect to the axis of the outer tube portion 20, and the pair of claw portions 46 are also positioned 180 degrees rotationally symmetrical with respect to the axis of the outer tube portion 20. As shown in Figures 2(a) and 3, each of the pair of protruding portions 42 is formed in a flat plate shape perpendicular to the axial direction. Furthermore, each of the pair of protruding portions 42 is wider toward the outer tube portion 20. This ensures sufficient bending rigidity of the pair of protruding portions 42. In this embodiment, one downward projection 44 protrudes downward from each of the two protruding portions 42 (the tip in the protruding direction). The upper part of the downward projection 44 gradually widens towards the protruding portion 42. The lower part of the downward projection 44 remains substantially constant regardless of its position in the vertical direction. This suppresses stress concentration at the boundary between the protruding portion 42 and the downward projection 44. Furthermore, as shown in Figure 3, each claw portion 46 protrudes radially inward from the lower end of the downward projection 44. The tip surface 46a (the tip in the projection direction) of each claw portion 46 is, for example, a flat surface perpendicular to the radial direction. Similarly, the upper end surface of each claw portion 46 is a flat surface perpendicular to the axial direction. In addition, a portion of both ends of each claw portion 46 in the circumferential direction is a chamfered shape (not shown). Furthermore, the connecting portion 40 has a cylindrical portion 41 that protrudes downward from the lower end of the outer tube portion 20. The outer diameter of the cylindrical portion 41 is set to be approximately the same as the inner diameter of the outer tube portion 20.
[0017] As shown in Figures 2(a), 2(b), and 3, the inner tube portion 30 includes, for example, a first cylindrical portion 31 that is inserted into the outer tube portion 20 so as to be slidable vertically, and a second cylindrical portion 36 that protrudes downward from an opening at the lower end of the first cylindrical portion 31. Each of the first cylindrical portion 31 and the second cylindrical portion 36 is formed in a cylindrical shape with the vertical direction as its axial direction. The lumen of the first cylindrical portion 31 and the lumen of the second cylindrical portion 36 are in communication with each other and constitute the lumen of the inner tube portion 30. The inner diameter of the first cylindrical portion 31 is set to be approximately the same as the outer diameter of the second cylindrical portion 36. The outer diameter of the first cylindrical portion 31 is set to be slightly smaller than the inner diameter of the outer tube portion 20. The upper end of the second cylindrical portion 36 is fitted into the lumen of the lower end of the first cylindrical portion 31, and the first cylindrical portion 31 and the second cylindrical portion 36 are integrally inserted into the lumen of the outer tube portion 20 so as to be slidable.
[0018] A pressing portion 38 is formed at the upper end of the first cylindrical portion 31, which is pressed downward by the user. When the pressing portion 38 is pressed downward, the inner tube portion 30 (the first cylindrical portion 31 and the second cylindrical portion 36) is pushed downward relative to the outer tube portion 20. The pressing portion 38 is formed, for example, as a flat plate perpendicular to the axis of the lumen of the inner tube portion 30. More specifically, the pressing portion 38 is formed as a flat plate that protrudes radially outward from the outer circumferential surface of the upper end of the first cylindrical portion 31, and its plate surface is perpendicular to the axial direction. In this embodiment, with respect to the axis AX of the inner tube portion 30, the amount of protrusion of the pressing portion 38 in one direction is greater than the amount of protrusion of the pressing portion 38 in the opposite direction to that one direction. As a result, even when the guide wire 500 is inserted into the lumen of the inner tube 30, the pushing operation can be easily performed by pressing the portion of the pressing part 38 that has a large amount of protrusion in one direction. More specifically, in this embodiment, the pressing portion 38 has a circular portion 38b that is substantially circular in plan view, and a protruding portion 38a that extends laterally (radially outward) from a portion of the peripheral edge of the circular portion 38b. The center of the circular portion 38b is positioned concentrically with the axis AX of the inner tube portion 30. The protruding portion 38a constitutes the part of the pressing portion 38 that has a large amount of protrusion in one direction.
[0019] Furthermore, in this embodiment, as shown in Figure 4, the area centroid A of the pressing portion 38 in plan view is offset with respect to the axis AX of the lumen of the inner tube portion 30. More specifically, in this embodiment, the center of the opening 39 is concentric with the axis AX of the lumen of the inner tube portion 30. Therefore, the end of the guide wire 500 is led out from a position offset from the area centroid A of the pressing portion 38 in a plan view. As a result, when pressing the pressing portion 38, even when the guide wire 500 is inserted into the lumen of the inner tube portion 30, it becomes easy to press the centroid A of the pressing portion 38 in a plan view while avoiding the end of the guide wire 500, thus enabling a smooth pushing operation.
[0020] As shown in Figures 2(a) and 2(b), the lower surface of the pressing portion 38 and the upper surface of the finger rest portion 25 face each other. As shown in Figure 8(a), during the pushing operation, the lower surface of the pressing portion 38 comes into contact with the upper surface of the finger rest portion 25, thereby restricting further downward movement of the inner tube portion 30 relative to the outer tube portion 20.
[0021] Furthermore, in this embodiment, the vertical dimension of the inner tube portion 30 is greater than the vertical dimension of the outer tube portion 20, and the lower end of the inner tube portion 30 protrudes from the opening on the lower end side of the outer tube portion 20. More specifically, the vertical dimension of the first cylindrical portion 31 is set to be approximately the same as or slightly smaller than the vertical dimension of the outer tube portion 20. On the other hand, the vertical dimension of the second cylindrical portion 36 is greater than the vertical dimension of the first cylindrical portion 31 and also greater than the vertical dimension of the outer tube portion 20. Therefore, at least the lower end of the second cylindrical portion 36 protrudes from the opening on the lower end side of the outer tube portion 20. As the inner tube portion 30 is pushed downward relative to the outer tube portion 20, the amount of protrusion of the second cylindrical portion 36 from the opening on the lower end side of the outer tube portion 20 increases.
[0022] The outer tube portion 20 and the first cylindrical portion 31 are integrally formed from, for example, a rigid resin material. The rigid resin material is not particularly limited, but examples include polyethylene, polyolefins such as polypropylene, polyamide, polycarbonate, and polystyrene. The second cylindrical portion 36 is made of a metal material such as stainless steel (SUS). The inner tube section 30 may, for example, be integrally molded as a whole. The outer tube section 20 may, for example, be constructed by assembling a plurality of individually molded components.
[0023] Furthermore, as described above, the insertion jig 100 includes a locking member 60 (see Figures 5(a) and 5(b), etc.) that is detachably attached to the outer tube portion 20 and the inner tube portion 30. In this embodiment, the locking member 60 has a base portion 62 and a bifurcated portion 64 that protrudes from the base portion 62 in a bifurcated manner. The base portion 62 is formed, for example, as a long, roughly rectangular flat plate. One surface of the base portion 62 is positioned facing the outer tube portion 20. As shown in Figures 3 and 4, the width dimension (lengthwise dimension) of the base portion 62 is set to be smaller than the maximum outer diameter (circular portion 38b) of the finger rest portion 25. This prevents the locking member 60 from interfering with the user's hand when the user grips the insertion jig 100. The bifurcated portion 64 is formed as a flat plate that protrudes from the surface of the base portion 62 on the outer tube portion 20 side in a direction perpendicular to the plate surface of the base portion 62. The plate surface of the bifurcated portion 64 is perpendicular to the longitudinal direction of the base portion 62 and also perpendicular to the axial direction. The bifurcated portion 64 has a notched portion 64a that penetrates the bifurcated portion 64 in the thickness direction. The notched portion 64a extends in a direction perpendicular to the plate surface of the base portion 62 and is open toward the outer tube portion 20 side. Because such a notched portion 64a is formed in the bifurcated portion 64, the bifurcated portion 64 is formed in a bifurcated shape that is open toward the outer tube portion 20 side.
[0024] The inner tube portion 30 has, for example, a constricted portion 33 (see Figures 5(c) and 5(d)) that engages with the bifurcated portion 64, and the engagement of the bifurcated portion 64 with respect to the constricted portion 33 restricts the vertical movement of the inner tube portion 30 relative to the outer tube portion 20. More specifically, on the outer circumferential surface of the first cylindrical portion 31, a portion in the axial direction is locally narrower in diameter, and this narrowed portion constitutes a constricted portion 33. Furthermore, as shown in Figures 1 and 2(b), the outer tube portion 20 has a notch 22 into which, for example, the bifurcated portion 64 can be inserted from the side. In this embodiment, two notches 22 are formed in the outer tube portion 20. The two notches 22 are positioned 180 degrees rotationally symmetrical to each other with respect to the axis of the outer tube portion 20. Each notch 22 is a slit that penetrates the inside and outside of the outer tube portion 20 and extends horizontally. Also, in this embodiment, as shown in Figure 3, each notch 22 is formed at the upper end of the outer tube portion 20. Therefore, the locking member 60 is attached to the upper end of the outer tube portion 20.
[0025] In this embodiment, as shown in Figure 5(d), the notches 22 and the constricted portion 33 are formed at positions corresponding to each other in the axial direction (the constricted portion 33 can be seen through the notches 22 when viewed from one side in the radial direction). Therefore, as shown in Figures 5(a) and 5(c), when the bifurcated portion 64 is inserted into each of the notches 22, the bifurcated portion 64 engages with a portion of the constricted portion 33 in the circumferential direction. More specifically, as shown in Figure 5(c), the maximum opening width of the notched portion 64a is smaller than the outer diameter of the first cylindrical portion 31 and is approximately the same as the outer diameter of the constricted portion 33. Furthermore, the dimensions of the axial cut 22 and the constricted portion 33 are set to approximately the same dimensions as, for example, the thickness of the bifurcated portion 64. When the bifurcated portion 64 is inserted into each notch 22, the bifurcated portion 64 engages with each notch 22, thereby restricting the vertical movement of the outer tube portion 20 relative to the locking member 60. Furthermore, since the bifurcated portion 64 fits into the constricted portion 33, the vertical movement of the inner tube portion 30 relative to the locking member 60 is restricted. Thus, the vertical movement of the inner tube portion 30 relative to the outer tube portion 20 is restricted. In this way, the locking member 60 is attached to the outer tube portion 20 and the inner tube portion 30, and the vertical movement of the inner tube portion 30 relative to the outer tube portion 20 is maintained in a restricted state.
[0026] In this embodiment, as shown in Figures 2(a) and 2(b), the gastrostomy catheter 200 further includes, in addition to the shaft 210, lumen 211, bumper 250, and capsule cover 260 described above, a body surface contact portion 220 provided at the upper end of the shaft, and a connected portion 230 formed at the upper end of the body surface contact portion and connected to the connecting portion 40. In this embodiment, with the connecting portion 40 connected to the connected portion 230, the portion of the second cylindrical portion 36 protruding from the opening at the lower end of the outer tube portion 20 is inserted into the lumen 211 and the interior of the capsule cover 260. The lower end of the second cylindrical portion 36 then presses the capsule cover 260 downward, causing the capsule cover 260 to detach from the bumper 250, thereby expanding the bumper 250. This locks the bumper 250 to the stomach wall 420 and places the gastrostomy catheter 200 in place. In this state, the gastrostomy catheter 200 connects the inside of the stomach with the outside of the body, and a liquid such as a nutritional supplement is injected into the stomach via the gastrostomy catheter 200. Note that the capsule cover 260 is not shown in Figures 1, 2(a), and 2(b). Also, in Figures 7(a) and 7(b), the retracted bumper 250 is shown by a dashed line.
[0027] In this embodiment, the lumen of the shaft 210 constitutes the lumen 211. As shown in Figures 2(a) and 2(b), the shaft 210 is formed in a cylindrical shape with its axial direction in the vertical direction. The outer diameter of the lower end of the shaft 210 is tapered in two stages, for example, downwards. The outer diameter of the upper end of the shaft 210 is relatively larger than that of the rest of the shaft 210. A connecting portion 230 is attached to the upper end of the shaft 210. The body surface contact portion 220 is the part exposed to the user's body surface when the gastrostomy catheter 200 is in place, and the lower surface of the body surface contact portion 220 faces the outer surface of the abdominal wall 410. The body surface contact portion 220 protrudes laterally from, for example, the outer peripheral surface of the upper end of the shaft 210. The lower surface of the body surface contact portion 220 is formed flat. In this embodiment, as described above, the insertion jig 100 is connected to the connecting portion 230 located at the upper end of the body surface contact portion 220, so the insertion jig 100 does not slip under the body surface contact portion 220. Therefore, the insertion jig 100 is not located below the lower surface of the body surface contact portion 220, and the lower surface of the body surface contact portion 220 is able to face the outer surface of the abdominal wall 410 directly. As a result, the lower surface of the body surface contact portion 220 can be positioned along the outer surface of the abdominal wall 410, so that the gastrostomy catheter 200 can be stably placed on the body surface.
[0028] The shaft 210 and the body surface contact portion 220 are integrally molded from, for example, a resin material. The resin material is not particularly limited, but examples include polyvinylidene fluoride resin, polytetrafluoroethylene resin, polyethylene resin, polypropylene resin, or silicone rubber or other rubber materials.
[0029] The capsule cover 260 is formed, for example, as a bottomed cylindrical shape with the vertical direction as its axial direction. The capsule cover 260 has, for example, a cylindrical mounting portion 262 that is attached to the bumper 250, and a tip closing portion 264 that closes the lower end of the mounting portion 262, the tip closing portion 264 being formed in a shape that bulges outwards in a convex manner. Furthermore, the capsule cover 260 has an insertion hole 261 for inserting the guide wire 500 vertically, located at the most bulging portion 266 of the tip closure portion 264, which protrudes the most downwards. However, the insertion hole 261 may be located, for example, near the most bulging portion 266. The inner and outer diameters of the mounting portion 262 are, for example, substantially constant regardless of their position in the axial direction. The tip closure portion 264 is formed, for example, in a rounded shape that is convex downwards. The inner diameter and outer diameter of the tip closure portion 264 each gradually decrease in diameter towards the bottom, for example. The insertion hole 261 penetrates the tip closure portion 264 vertically, for example. The axial center of the insertion hole 261 coincides with the axial center of the mounting portion 262, for example. The outer diameter of the insertion hole 261 is substantially constant, for example, regardless of its position in the axial direction. The outer diameter of the insertion hole 261 is set to a dimension smaller than, for example, the inner diameter and outer diameter of the second cylindrical portion 36. In this embodiment, for example, the thickness of each part of the capsule cover 260 is approximately constant. However, as shown in Modification 1 described later, the thickness of each part of the capsule cover 260 may differ depending on the location. The materials constituting the capsule cover 260 are not particularly limited, but examples include cellulose-based or gelatin-based edible materials, or biodegradable materials such as polylactic acid.
[0030] As shown in Figure 7(a), before the gastrostomy catheter 200 is placed, the bumper 250 is housed in a contracted state inside the capsule cover 260. The upper end of the mounting portion 262 of the capsule cover 260 is attached, for example, to the upper end of the bumper 250, and consequently to the lower end of the shaft 210. The lower end of the second cylindrical portion 36 is inserted into the mounting portion 262, and the lower end of the second cylindrical portion 36 faces the inner circumferential surface of the tip closure portion 264 in the vertical direction, for example. The insertion hole 261 is positioned at a location corresponding to the axial center of the inner tube portion 30 (second cylindrical portion 36). The guide wire 500 is inserted into the capsule cover 260 through the insertion hole 261 and further inserted into the lumen of the inner tube portion 30 from the opening on the lower end side of the second cylindrical portion 36. When the lower end of the cylindrical portion 30 presses the capsule cover 260 downward, for example, the lower end of the second cylindrical portion 36 comes into contact with the edge 263 of the insertion hole 261 in the tip closing portion 264. Here, the outer diameter of the insertion hole 261 is, for example, 1.1 mm or more and 1.5 mm or less. Having an outer diameter of 1.1 mm or more allows the guide wire 500 to be easily guided out from the insertion hole 261. Having an outer diameter of 1.5 mm or less allows the edge 263 of the insertion hole 261 to be effectively pressed by the lower end of the second cylindrical portion 36 (preventing the lower end of the second cylindrical portion 36 from being inserted into the insertion hole 261).
[0031] The bumper 250 is flexible and expandable in the radial direction. A portion of a wire (not shown) is arranged inside the bumper 250 in a coiled manner. One end of the wire is introduced into the bumper 250 through an inlet hole 212 formed in the shaft 210 (see Figure 8(a), etc.), and the other end is led to the outside of the bumper 250 through the inlet hole 212. The entry hole 212 is formed, for example, at a position offset from the central axis of the shaft 211. As shown in Figure 8(a), when the capsule cover 260 is detached from the bumper 250, the bumper 250 expands radially due to the elastic restoring force of the wire and locks into the stomach wall 420. Then, from this state, when the wire inside the bumper 250 is removed from the bumper 250, the bumper 250 contracts radially and its locking into the stomach wall 420 is released. The gastrostomy catheter 200 may, for example, be equipped with a balloon (not shown) instead of a bumper 250. In this case, saline solution or distilled water is injected into the balloon, causing it to inflate and lock onto the stomach wall 420. Then, by draining the saline solution or distilled water from inside the balloon, the balloon deflates, and its lock onto the stomach wall 420 is released.
[0032] Furthermore, the connected portion 230 is equipped with, for example, a check valve 240 (see Figures 2(a) and 2(b)), which allows the nutritional supplement to pass from outside the body into the stomach, while restricting the reflux of stomach contents from the stomach to outside the body. In this embodiment, the check valve 240 is, for example, a duckbill valve. The check valve 240 is fitted, for example, into the lumen at the upper end of the lumen 211. Under normal conditions, the check valve 240 closes the opening at the upper end of the lumen 211, but when injecting nutritional supplements into the stomach via the gastrostomy catheter 200, it connects the lumen 211 with the outside of the body. Furthermore, when the connecting portion 40 is locked to the connected portion 230, as shown in Figure 2(b), the second cylindrical portion 36 is inserted through the check valve 240 from top to bottom and is slidable up and down within the lumen of the check valve 240.
[0033] As shown in Figures 2(b) and 6(b), the connected portion 230 is formed in a flattened cylindrical shape, for example, with an axial dimension smaller than the radial dimension. The connected portion 230 includes a cylindrical main body portion 230b and an inner flange portion 230a that protrudes radially inward from the upper end of the main body portion 230b. The inner periphery of the inner flange portion 230a defines the opening 231 on the upper end side of the connected portion 230. The outer diameter of the opening 231 is set to be larger than the cylindrical portion 41 of the outer tube portion 20. As shown in Figure 2(b), the outer diameter of the connected portion 230 is set to a dimension approximately equivalent to the distance (radial distance) between the inner surfaces (outer tube side surfaces) of the pair of downward protrusions 44. Therefore, when the connecting portion 40 is inserted into the connected portion 230 from above, the connected portion 230 is positioned between the pair of downward protrusions 44.
[0034] Here, for example, as shown in Figures 2(b), 6(a), and 6(b), a pair of recesses 232 are formed on the outer circumferential surface of the main body portion 230b of the connected portion 230, and the connecting portion 40 is hooked onto the connected portion 230 by engaging the corresponding claw portion 46 with each recess 232. Each of the pair of recesses 232 is recessed radially inward and extends circumferentially. The pair of recesses 232 are positioned 180 degrees rotationally symmetric to each other with respect to the axis of the connected portion 230, for example, and are also rotationally symmetric to each other. The depth of each recess 232 (radial dimension) is set to approximately the same dimension as, for example, the protruding length of a pair of claw portions 46. In the radial direction, the distance between the outer surfaces 232d of each recess 232 is set to approximately the same dimension as the distance between the tip surfaces 46a of each claw portion 46. The width dimension (axial dimension) of each recess 232 is set to approximately the same dimension as, for example, the thickness dimension (axial dimension) of a pair of claw portions 46.
[0035] As shown in Figures 6(a) and 6(b), each recess 232 is, for example, a groove extending in the circumferential direction. The other end 232c of each recess 232 in the circumferential direction reaches the upper end of the main body 230b and opens upward (hereinafter referred to as the opening 232a). Furthermore, at the upper end of the connected portion 230, each recess 232 is defined, and the areas where the opening 232a is not formed become detachment restricting portions 234 that the corresponding claw portions 46 abut against. The lower surface of the detachment restricting portion 234 is the top surface of the recess 232. Furthermore, a convex portion 233 is formed at one end 232b of the recess 232, for example, extending radially outward from the outer surface 232d of the recess 232. The protruding length (radial dimension) of the convex portion 233 is set to a dimension smaller than the formation depth, for example.
[0036] As shown in Figures 6(a) and 6(b), for example, by inserting a pair of claw portions 46 into the connected portion 230 from above and rotating the outer tube portion 20 and the connecting portion 40 in one direction around the axis, the connecting portion 40 is hooked onto the connected portion 230 while the pair of claw portions 46 are prevented from falling out upward from the connected portion 230.
[0037] More specifically, in order to engage the connecting portion 40 with the connected portion 230, first, a pair of claw portions 46 are inserted into the connected portion 230 from above, and the cylindrical portion 41 of the connecting portion 40 is inserted into the lumen of the check valve 240 through the opening 231 of the connected portion 230. At this time, each claw portion 46 is inserted into the interior of the corresponding recess 232 through the opening 232a of the recess 232 and positioned at the other end 232c of the recess 232. In this state, the tip surface 46a of each claw portion 46 is in contact with the outer surface 232d of the corresponding recess 232. Next, the connecting portion 40 and the connected portion 230 are rotated relative to each other around their axis. For example, when the connecting portion 40 is rotated in the direction of the arrow shown in Figure 6(b) (clockwise as an example), each claw portion 46 is guided by the outer surface 232d and moves from the other end 232c side of the recess 232 to the one end 232b side. This rotation operation is continued until each claw portion 46 has overcome the corresponding protrusion 233 (see Figure 6(b)). In this state, the upper end surface of each claw portion is in contact with the lower surface of the corresponding detachment restricting portion 234. As a result, with the pair of claw portions 46 prevented from detaching upward from the connected portion 230, the connecting portion 40 is hooked onto the connected portion 230, and the insertion jig 100 is attached to the gastrostomy catheter 200. In this embodiment, the dimension of the recess 232 on the side of one end 232b relative to the convex portion 233 in the circumferential direction is set to be approximately equal to the width dimension of the claw portion 46. Therefore, when rotation is performed, after each claw portion 46 overcomes each convex portion 233, each claw portion 46 engages with the gap between the end face on the side of one end 232b of the recess 232 and the convex portion 233. This restricts the relative displacement of the connecting portion 40 with respect to the connected portion 230 in the rotational direction. As a result, rattling of the connecting portion 40 in the rotational direction is reduced, and the state in which the connecting portion 40 is hooked onto the connected portion 230 can be stably maintained. Furthermore, as described above, a chamfered shape is formed on a part of both ends of each claw portion 46 in the circumferential direction. Therefore, when rotation is performed, each claw portion 46 can smoothly overcome the corresponding convex portion 233. Furthermore, as each claw portion 46 moves from one end 232b to the other end 232c, a clicking sensation is generated as each claw portion 46 overcomes each protrusion 233. This clicking sensation allows the user to easily recognize that the connection of the connecting portion 40 to the connected portion 230 has been completed.
[0038] Furthermore, for example, from a state in which the connecting portion 40 is hooked onto the connected portion 230, the tubular body 10 and the connecting portion 40 are rotated around the axis in opposite directions to one direction, and the pair of claw portions 46 are pulled upward from the connected portion 230, thereby separating the connecting portion 40 from the connected portion 230.
[0039] More specifically, from a state in which the pair of claw portions 46 are prevented from falling upward from the connected portion 230 (as shown in Figure 6(b)), by rotating the connecting portion 40 in the opposite direction of the arrow shown in Figure 6(b) (for example, counterclockwise), each claw portion 46 is guided by the outer surface 232d and moves from one end 232b side to the other end 232c side of the recess 232. This rotation operation is continued until each claw portion 46 moves to a position corresponding to the opening 232a. In this state, by pulling the pair of claw portions 46 upward from the connected portion 230, the connecting portion 40 is separated from the connected portion 230, and the insertion jig 100 can be removed from the gastrostomy catheter 200. In this embodiment, the chamfered shape of each claw portion 46 allows each claw portion 46 to smoothly overcome each protrusion 233 even when the connecting portion 40 is rotated counterclockwise. However, for example, the chamfered shape of the claw portion 46 may be formed on the other end 232c side in the circumferential direction, but not on the one end 232b side. By doing so, each claw portion 46 becomes less likely to move from the one end 232b side to the other end 232c side (it becomes less likely to overcome the protrusion 233), so the state in which the connecting portion 40 is hooked onto the connected portion 230 can be maintained well. Furthermore, as each claw portion 46 moves from one end 232b to the other end 232c, a clicking sensation is generated as each claw portion 46 overcomes the protrusion 233. This clicking sensation allows the user to easily recognize that the separation of the connecting portion 40 from the connected portion 230 has begun.
[0040] The following describes an example of how to use the gastrostomy catheter kit 300, which includes the gastrostomy catheter 200 and the insertion jig 100 for the gastrostomy catheter, using Figures 7(a) to 8(b). The description begins with the assumption that the fistula 430 into which the guidewire 500 is inserted is formed by penetrating the abdominal wall 410 and the stomach wall 420, and that the guidewire 500 is inserted through the fistula 430. First, the insertion jig 100 is attached to the gastrostomy catheter 200 by connecting the connecting part 40 to the connected part 230. Next, as shown in Figure 7(a), one end of the guidewire 500 is inserted into the lumen of the inner tube 30 through the insertion hole 261 of the capsule cover 260. The end of the guidewire 500 inserted into the lumen of the inner tube 30 is led out to the outside through the opening 39 on the upper end side of the first cylindrical part 31. Then, along the guidewire 500, the shaft 210 and the lower end of the second cylindrical part 36 are inserted into the lumen of the fistula 430, and the bumper 250 is positioned in the stomach. In this state, the body surface contact portion 220 and the portion above the body surface contact portion 220 of the gastrostomy catheter kit 300 are positioned along the body surface. Next, as shown in Figures 7(b) and 8(a), the locking member 60 is removed from the outer tube portion 20 and the inner tube portion 30. Then, the inner tube portion 30 is pushed downward relative to the outer tube portion 20. As a result, the lower end of the second cylindrical portion 36 presses downward against the capsule cover 260, causing the capsule cover 260 to detach from the bumper 250 and the bumper 250 to expand. This locks the bumper 250 against the stomach wall 420, and the gastrostomy catheter 200 is placed. After the gastrostomy catheter 200 is placed, the guidewire 500 is removed from the lumen of the inner tube portion 30. However, for example, the guidewire 500 may be removed from the lumen of the inner tube portion 30 before performing the pushing operation. Furthermore, the capsule cover 260, detached from the bumper 250, is made of edible material or a material that is biodegradable in the body, as described above, and is therefore excreted with the stomach contents or dissolved in the stomach. Once the gastrostomy catheter 200 is in place, the connection of the connecting part 40 to the connected part 230 is released, as shown in Figure 8(b), and the insertion jig 100 is removed from the gastrostomy catheter 200.
[0041] <Example 1> Next, a modified example 1 of the embodiment will be described using Figures 9 to 11. The capsule cover 260 in this modified example differs from the capsule cover 260 in the above embodiment in the respects described below, and is otherwise configured the same as the capsule cover 260 in the above embodiment.
[0042] As shown in Figures 10(a) and 10(b), in this modified example, in the capsule cover 260, the thickness T2 of the edge portion 263 (Figure 9) of the insertion hole 261 in the tip closing portion 264 is greater than the thickness T1 of the mounting portion 262. As described above, when the cylindrical portion 30 presses against the capsule cover 260, the lower end of the second cylindrical portion 36 comes into contact with the edge 263 of the insertion hole 261 in the tip closing portion 264. Therefore, when the capsule cover 260 is pressed downward by the lower end of the cylindrical portion 30, it is possible to prevent the lower end of the second cylindrical portion 36 from penetrating the tip closure portion 264.
[0043] More specifically, in this modified example, the inner circumferential surface of the edge portion 263 is, for example, formed flat and positioned facing upward. This allows the lower end surface of the second cylindrical portion 36 to contact the inner circumferential surface of the edge portion 263 in a circumferential manner, so that the lower end of the second cylindrical portion 36 can effectively press against the tip closing portion 264. On the other hand, the outer circumferential surface of the edge portion 263 is formed in a curved shape that is convex downwards, for example. The radius of curvature of the outer circumferential surface of the edge portion 263 is smaller than the radius of curvature of the portion of the tip closing portion 264 other than the edge portion 263.
[0044] The thickness T1 of the mounting portion 262 is, for example, 0.3 mm or more and 0.6 mm or less. By having a thickness T1 of 0.3 mm or more of the mounting portion 262, sufficient structural strength of the capsule cover 260 can be ensured, and deformation of the capsule cover 260 due to the elastic restoring force of the bumper 250 can be suppressed. By having a thickness T1 of 0.6 mm or less of the mounting portion 262, when the capsule cover 260 is detached from the bumper 250, the capsule cover 260 can be made to decompose within the body. The thickness T2 of the edge 263 of the insertion hole 261 in the tip closure portion 264 is, for example, 0.8 mm or more. This makes it possible to more reliably prevent the lower end of the second cylindrical portion 36 from penetrating the tip closure portion 264 when the capsule cover 260 is pressed downward by the lower end of the cylindrical portion 30. Furthermore, as shown in Figure 11, the outer diameter of the edge portion 263 is, for example, larger than both the inner and outer diameters of the second cylindrical portion 36. This ensures sufficient contact area between the inner circumferential surface of the edge portion 263 and the lower end surface of the second cylindrical portion 36.
[0045] <Modification 2> Next, a modified example 2 of the embodiment will be described using Figures 12 to 15. The capsule cover 260 in this modified example differs from the capsule cover 260 in the above embodiment and modified example 1 in the points described below, and is otherwise configured the same as the capsule cover 260 in the above embodiment and modified example 1. In Figure 15, the inner peripheral edge 30a at the lower end of the inner tube portion 30 is shown by a dashed line.
[0046] In this modified example, as shown in Figures 13(a) and 13(b), the most protruding portion 266 of the tip-closed portion 264, which bulges the most downwards, is positioned at an offset location with respect to the axial center AX1 of the mounting portion 262. The insertion hole 261 is positioned near the most protruding portion 266. That is, the insertion hole 261 is positioned at an offset location with respect to the axial center AX1 of the mounting portion 262. Here, as shown in Figure 14, when the capsule cover 260 is attached to the bumper 250, the axial center AX2 of the inner tube portion 30 may be positioned at a location offset from, for example, the axial center AX1 of the mounting portion 262. More specifically, because one end of the wire inside the bumper 250 is inserted into an introduction hole 212 formed at an offset position relative to the shaft 211, or because it is difficult to fold the bumper 250 isotropically, the rigidity of the bumper 250 housed in the capsule cover 260 may be biased to one side in the radial direction. In this case, as shown in Figure 14, when the gastrostomy catheter 200 is placed, the lower end of the inner tube portion 30 inside the bumper 250 is biased radially from the side with higher rigidity of the bumper 250 (in this modified example, the introduction hole 212 side) to the opposite side. As a result, the axial center AX2 of the inner tube portion 30 is positioned, for example, offset from the axial center AX1 of the mounting portion 262.
[0047] According to this modified example, even in such a case, since the insertion hole 261 is positioned at an offset position with respect to the axial center AX1 of the mounting portion 262, the rotational phase of the capsule cover 260 around the axis of the mounting portion 262 can be adjusted so that the insertion hole 261 is positioned at a position corresponding to the extension line of the axial center AX2 of the inner tube portion 30. This allows the lower end of the inner tube section 30 (the lower end of the second cylindrical section 36) to be positioned in a location corresponding to the insertion hole 261, so that the guide wire 500 led out through the insertion hole 261 can be easily inserted into the lumen of the inner tube section 30 (the lumen of the second cylindrical section 36). In this context, "position corresponding to the insertion hole 261" refers to the portion that overlaps with the insertion hole 261 in a plan view, as shown in Figure 15. In the present invention, it is preferable that, in a plan view, at least a portion of the inner peripheral edge 30a of the lower end of the inner tube portion 30 is positioned in a location that corresponds to (overlaps with) the insertion hole 261. Furthermore, in the example shown in Figure 14, the rotational phase of the capsule cover 260 around the axis of the mounting portion 262 is adjusted such that the insertion hole 261 is positioned offset from the radially opposite side of the introduction hole 212, with respect to the axial center AX1 of the mounting portion 262.
[0048] Furthermore, in this modified example, in a cross-section obtained by cutting the capsule cover 260 in a plane including the axial center AX3 of the insertion hole 261 and the axial center AX1 of the mounting portion 262 (see Figure 13(a)), the tip closing portion 264 has a first wall portion 267 connecting the insertion hole 261 and one wall portion 262a of the mounting portion 262, and a second wall portion 268 connecting the insertion hole 261 and the other wall portion 262b of the mounting portion 262. Here, the connection point between the second wall portion 268 and the other wall portion 262b of the mounting portion 262 (P21 and P22, described later in this modified example) is higher than the connection point between the first wall portion 267 and one wall portion 262a of the mounting portion 262 (P11 and P12, described later in this modified example). Also, in a cross-section obtained by cutting the capsule cover 260 in a plane including the axis center AX3 of the insertion hole 261 and the axis center AX1 of the mounting portion 262 (see Figure 13(a)), the most bulging portion 266 is positioned, for example, offset from the axis center AX1 of the mounting portion 262 towards the connection points P11 and P12. With this configuration, compared to the capsule cover 260 in the embodiment and modified example 1, the tip closure portion 264 has a tapered shape that slopes downward from the connection points P21 and P22 towards the connection points P11 and P12. Therefore, the capsule cover 260 can be easily inserted into the fistula 430. In this modified example, for instance, the connection point between the inner surface of the first wall portion 267 and the inner surface of one wall portion 262a of the mounting portion 262 is referred to as P11, and the connection point between the outer surface of the first wall portion 267 and the outer surface of one wall portion 262a of the mounting portion 262 is referred to as P12. Similarly, the connection point between the inner surface of the second wall portion 268 and the inner surface of the other wall portion 262b of the mounting portion 262 is referred to as P21, and the connection point between the inner surface of the second wall portion 268 and the inner surface of the other wall portion 262b of the mounting portion 262 is referred to as P22. Furthermore, the lower-positioned of P21 and P22 is at a higher position than the higher-positioned of P11 and P12.
[0049] Furthermore, in this modified example, the area occupied by the second wall portion 268 in the tip-closing portion 264 is larger than the area occupied by the first wall portion 267. As a result, compared to the capsule cover 260 in the embodiment and modified example 1, the tip closure portion 264 can sufficiently secure a surface (blade surface) that is inclined (i.e., downward inclined) from the connection point P21, P22 side toward the connection point P11, P12 side, so that the capsule cover 260 can be inserted into the fistula 430 more easily. However, even in this modified example, it is preferable that the tip closure portion 264 has a rounded shape. More specifically, it is preferable that the entire tip closure portion 264 does not include, for example, an inwardly convex portion, and more preferably, the entire portion is an outwardly arc-shaped convex portion.
[0050] In this modified example, in the capsule cover 260, the portion of the capsule cover 260 whose radial distance from the axial center AX1 is the same as the inner diameter of the upper end of the capsule cover 260 constitutes the mounting portion 262, and the portion smaller than the inner diameter constitutes the tip closing portion 264. Furthermore, in this modified example, as shown in Figure 12, in a plan view, with respect to a virtual line perpendicular to the virtual line connecting connection points P11, P12 and connection points P21, P22 in the mounting portion 262 and passing through the center C1 of the insertion hole 261, the portion on the connection point P11, P12 side is one wall portion 262a, and the portion on the connection point P21, P22 side is the other wall portion 262b. Similarly, in a plan view, with respect to the above-mentioned imaginary line, the portion of the tip-closing portion 264 on the connection point P11 and P12 side is the first wall portion 267, and the portion on the connection point P21 and P22 side is the second wall portion 268. In the tip-closed portion 264, the area occupied by the second wall portion 268 is preferably at least twice the area occupied by the first wall portion 267, and more preferably at least three times the area occupied by the first wall portion 267. Furthermore, as shown in Figure 13(a), the second wall portion 268 includes, for example, a first portion 268a which is the most bulging portion 266 and the portion near it, and a second portion 268b which is the portion of the second wall portion 268 other than the first portion 268a (for example, above the intersection of the central axis AX and the tip closing portion 264). The first portion 268a is connected to the lower side of the second portion 268b, and the second portion 268b is connected to the lower side of the other wall portion 262b of the mounting portion 262. In this modified example, the second portion 268b slopes downward from, for example, the P21 and P22 side toward the most protruding portion 266 (first portion 268a), and the first portion 268a slopes slightly upward from the second portion 268b side toward the P11 and P12 side. The radius of curvature of the second portion 268b is, for example, larger than the radius of curvature of the first portion 268a. Also, in the second wall portion 268, the proportion of the area occupied by the second portion 268b is, for example, larger than the proportion of the area occupied by the first portion 268a. Furthermore, in the tip-closed portion 264, it is preferable that the radius of curvature of the second portion 268b of the second wall portion 268 is larger than, for example, the radius of curvature of the first wall portion 267. The radius of curvature of the first portion 268a may be larger than or smaller than the radius of curvature of the first wall portion 267. Furthermore, in this modified example, for instance, the first portion 268a of the second wall portion 268 constitutes a part of the edge portion 263, and therefore the through hole 261 is located near the most bulging portion 266. More specifically, as an example, the through hole 261 is located at a position offset radially outward from the most bulging portion 266 with respect to the axial center AX1. Alternatively, the through hole 261 may be located above the most bulging portion 266. However, the present invention is not limited to this example, and the through hole 261 may be located, for example, at the most bulging portion 266.
[0051] Thus, in this modified example, the most protruding portion 266 of the tip closure portion 264, which bulges the most downwards, is positioned offset from the axial center AX1 of the mounting portion 262. The capsule cover 260 has an insertion hole 261 for inserting the guide wire 500 vertically at or near the most protruding portion 266. When the capsule cover 260 is mounted on the bumper 250, the axial center AX1 of the mounting portion 262 is positioned offset from the extension line of the axial center AX2 of the inner tube portion 30. The rotational phase of the capsule cover 260 around the axis of the mounting portion 262 is adjusted so that the insertion hole 261 is positioned in a position corresponding to the extension line of the axial center AX2 of the inner tube portion 30, and the capsule cover 260 is mounted on the bumper 250.
[0052] In this modified example, for example, similar to Modified Example 1 described above, the thickness of the edge 263 of the insertion hole 261 in the tip closing portion 264 may be greater than the thickness of the mounting portion 262. By doing so, when the capsule cover 260 is pressed downward by the lower end of the cylindrical portion 30, it is possible to prevent the lower end of the second cylindrical portion 36 from penetrating the tip closing portion 264.
[0053] The present invention is not limited to the embodiments described above, and includes various modifications, improvements, and other forms as long as the objectives of the present invention are achieved.
[0054] This embodiment encompasses the following technical concepts. (1) An insertion device used for inserting and leaving in place a gastrostomy catheter through a fistula, the gastrostomy catheter having a shaft with a lumen, a bumper provided at the lower end of the shaft that expands in the stomach, and a capsule cover that maintains the bumper in a contracted state, An outer tube portion having a connecting portion that is detachably connected to the upper end of the shaft, An inner tube portion is inserted into the lumen so as to be able to insert a guide wire and slide vertically relative to the outer tube portion, Equipped with, The upper end of the inner tube section is formed with a pressing portion that is pressed downward by the user. The pressing force applied to the pressing portion causes the inner tube portion to be pushed downward relative to the outer tube portion, thereby causing the lower end of the inner tube portion to press the capsule cover downward, detaching the capsule cover from the bumper and expanding the bumper. The lumen of the inner tube portion is open at the upper end surface of the pressing portion. The insertion jig further includes a locking member that is detachably attached to the outer tube portion and the inner tube portion, The locking member, when attached to the outer tube and the inner tube, maintains a state in which the vertical movement of the inner tube relative to the outer tube is restricted, in the insertion jig for a gastrostomy catheter. (2) The pressing portion is formed in the shape of a flat plate perpendicular to the axis of the lumen of the inner tube portion, An insertion jig for a gastrostomy catheter according to (1), wherein, with respect to the axis, the amount of protrusion of the pressing portion in one direction is greater than the amount of protrusion of the pressing portion in the opposite direction to that one direction. (3) The locking member has a base portion and a bifurcated portion that protrudes from the base portion in a bifurcated manner, The outer tube portion has a notch into which the bifurcated portion can be inserted from the side. The inner tube portion has a constricted portion that engages with the bifurcated portion, The insertion jig for a gastrostomy catheter according to (1) or (2), wherein the bifurcated portion engages with the constricted portion, thereby restricting the vertical movement of the inner tube relative to the outer tube. (4) The insertion jig for a gastrostomy catheter according to any one of (1) to (3), wherein the area centroid of the pressing portion in a plan view is offset with respect to the axis of the lumen of the inner tube portion. (5) The capsule cover has a cylindrical mounting portion that is attached to the bumper and a tip closing portion that closes the lower end of the mounting portion, The aforementioned tip-closed portion is formed in a shape that bulges outwards in a convex manner. The insertion jig for a gastrostomy catheter according to any one of (1) to (4), wherein the capsule cover has an insertion hole for inserting the guide wire vertically at the most bulging portion of the tip occlusion, or near thereto, which is the portion that bulges most downwards. (6) An insertion device used for inserting and leaving in place a gastrostomy catheter through a fistula, the gastrostomy catheter having a shaft with a lumen, a bumper provided at the lower end of the shaft that expands in the stomach, and a capsule cover that maintains the bumper in a contracted state, An outer tube portion having a connecting portion that is detachably connected to the upper end of the shaft, An inner tube portion is inserted into the lumen so as to be able to insert a guide wire and slide vertically relative to the outer tube portion, Equipped with, As the inner tube portion is pushed downward relative to the outer tube portion, the lower end of the inner tube portion presses the capsule cover downward, making it possible to detach the capsule cover from the bumper and expand the bumper. The capsule cover has a cylindrical mounting portion that is attached to the bumper, and a tip closing portion that closes the lower end of the mounting portion. The aforementioned tip-closed portion is formed in a shape that bulges outwards in a convex manner. An insertion jig for a gastrostomy catheter, wherein the capsule cover has an insertion hole for inserting the guide wire vertically, located at or near the most bulging portion of the tip occlusion that protrudes downwards. (7) The most bulging portion of the tip-closed portion is positioned at an offset position with respect to the axial center of the mounting portion, When the capsule cover is attached to the bumper, the axial center of the attachment portion is positioned at a location offset from the extension line of the axial center of the inner tube portion. An insertion jig for a gastrostomy catheter according to (5) or (6), wherein the rotational phase of the capsule cover around the axis of the mounting portion is adjusted so that the insertion hole is positioned at a location corresponding to the extension of the axis center of the inner tube portion, and the capsule cover is mounted on the bumper. (8) In a cross-section obtained by cutting the capsule cover in a plane that includes the axis of the insertion hole and the axis of the mounting portion, The tip closing portion has a first wall portion connecting the insertion hole and one wall portion of the mounting portion, and a second wall portion connecting the insertion hole and the other wall portion of the mounting portion. The insertion jig for a gastrostomy catheter according to (7), wherein the position of the connection point between the second wall portion and the other wall portion of the mounting portion is higher than the position of the connection point between the first wall portion and the one wall portion of the mounting portion. (9) An insertion jig for a gastrostomy catheter according to any one of (5) to (8), wherein the thickness of the edge of the insertion hole in the tip occlusion portion is greater than the thickness of the mounting portion. (10) The insertion jig for a gastrostomy catheter as described in (9), wherein the thickness of the mounting portion is 0.3 mm or more and 0.6 mm or less. (11) The insertion jig for a gastrostomy catheter according to (9) or (10), wherein the thickness of the edge of the insertion hole in the tip occlusion portion is 0.8 mm or more. (12) An insertion device for a gastrostomy catheter as described in any one of items (1) to (11), The aforementioned gastrostomy catheter, A gastrostomy catheter kit equipped with [features / equipment]. [Explanation of symbols]
[0055] 20 Outer tube section 22 cuts 25 Finger rest 30 Inner pipe section 30a Inner periphery 31 First cylindrical part 33. Constricted area 36 Second cylindrical part 38 Pressing part 38a Overhang 38b Circular section 39 Aperture 40 Connection part 41 Cylindrical section 42 A pair of protruding parts 44 Downward protrusion 46 Pair of claws 46a Tip surface 47 Protrusion 60 Locking member 62 Base section 64 Bifurcated part 64a Notched section 71 Pair of extending parts 73 Pair of extending connecting parts 100 Insertion tool for gastrostomy catheter 200 Gastrostomy Catheters 210 shaft 211 lumens 212 Inlet holes 220 Body surface contact part 230 Connected part 230a Inner flange section 230b Main body 231 Aperture 232 recess 232a aperture 232b One end 232c Other end 232d External surface 233 Convex part 240 Check valve 241 recess 250 Bumper 260 Capsule Covers 261 Through hole 262 Mounting part 262a One wall section 262b Other wall section 263 Edge 264 Tip occlusion 266 The most expanded part 267 1st wall 268 2nd wall 268a Part 1 268b Part 2 300 Gastrostomy Catheter Kit 410 Abdominal wall 420 Stomach wall 430 Fistula 500 guide wires A area centroid AX axis center AX1, AX2, AX3 axis center P11, P12, P21, P22 connection points T1, T2 thickness
Claims
1. An insertion jig used for inserting and leaving in place a gastrostomy catheter through a fistula, the gastrostomy catheter having a shaft with a lumen, a bumper provided at the lower end of the shaft that expands in the stomach, and a capsule cover that maintains the bumper in a contracted state, An outer tube portion having a connecting portion that is detachably connected to the upper end of the shaft, An inner tube portion is inserted into the lumen so as to be able to insert a guide wire and slide vertically relative to the outer tube portion, Equipped with, The upper end of the inner tube section is formed with a pressing portion that is pressed downward by the user. The pressing force applied to the pressing portion causes the inner tube portion to be pushed downward relative to the outer tube portion, thereby causing the lower end of the inner tube portion to press the capsule cover downward, detaching the capsule cover from the bumper and expanding the bumper. The lumen of the inner tube portion is open at the upper end surface of the pressing portion. The insertion jig further includes a locking member that is detachably attached to the outer tube portion and the inner tube portion, The locking member, when attached to the outer tube and the inner tube, maintains a state in which the vertical movement of the inner tube relative to the outer tube is restricted, in the insertion jig for a gastrostomy catheter.
2. The pressing portion is formed in a flat plate shape perpendicular to the axis of the lumen of the inner tube portion, The insertion jig for a gastrostomy catheter according to claim 1, wherein, with respect to the axis, the amount of protrusion of the pressing portion in one direction is greater than the amount of protrusion of the pressing portion in the opposite direction to that one direction.
3. The locking member has a base portion and a bifurcated portion that protrudes from the base portion in a bifurcated manner. The outer tube portion has a notch into which the bifurcated portion can be inserted from the side. The inner tube portion has a constricted portion that engages with the bifurcated portion, The insertion jig for a gastrostomy catheter according to claim 1 or 2, wherein the bifurcated portion engages with the constricted portion, thereby restricting the vertical movement of the inner tube relative to the outer tube.
4. An insertion jig for a gastrostomy catheter according to any one of claims 1 to 3, wherein the area centroid of the pressing portion in a plan view is offset with respect to the axis of the lumen of the inner tube portion.
5. The capsule cover has a cylindrical mounting portion that is attached to the bumper, and a tip closing portion that closes the lower end of the mounting portion. The aforementioned tip-closed portion is formed in a shape that bulges outwards in a convex manner. The insertion jig for a gastrostomy catheter according to any one of claims 1 to 4, wherein the capsule cover has an insertion hole for inserting the guide wire vertically at the most bulging portion of the tip occlusion, or near thereto, which is the portion that bulges most downwards.
6. An insertion jig used for inserting and leaving in place a gastrostomy catheter through a fistula, the gastrostomy catheter having a shaft with a lumen, a bumper provided at the lower end of the shaft that expands in the stomach, and a capsule cover that maintains the bumper in a contracted state, An outer tube portion having a connecting portion that is detachably connected to the upper end of the shaft, An inner tube portion is inserted into the lumen so as to be able to insert a guide wire and slide vertically relative to the outer tube portion, Equipped with, As the inner tube portion is pushed downward relative to the outer tube portion, the lower end of the inner tube portion presses the capsule cover downward, making it possible to detach the capsule cover from the bumper and expand the bumper. The capsule cover has a cylindrical mounting portion that is attached to the bumper, and a tip closing portion that closes the lower end of the mounting portion. The aforementioned tip-closed portion is formed in a shape that bulges outwards in a convex manner. The capsule cover has an insertion hole for inserting the guide wire vertically at the most protruding portion of the tip closure, or near thereto, The most bulging portion of the tip-closed part is positioned at an offset location with respect to the axial center of the mounting part. In a view from the bottom, the insertion hole is positioned at an offset location with respect to the axial center of the mounting portion. When the capsule cover is attached to the bumper, the axial center of the attachment portion is positioned at a location offset from the extension line of the axial center of the lower end of the inner tube portion. An insertion jig for a gastrostomy catheter, wherein the rotational phase of the capsule cover around the axis of the mounting portion is adjusted so that the insertion hole is positioned corresponding to the extension of the axis center of the lower end of the inner tube portion, and the capsule cover is attached to the bumper.
7. The insertion jig for a gastrostomy catheter according to claim 6, wherein, in a view from the bottom, the entire insertion hole is positioned at an offset location with respect to the axial center of the mounting portion.
8. In a cross-section obtained by cutting the capsule cover along a plane that includes the axial center of the insertion hole and the axial center of the mounting portion, The aforementioned tip-closing portion has a first wall portion connecting the insertion hole and one wall portion of the mounting portion, and a second wall portion connecting the insertion hole and the other wall portion of the mounting portion. The insertion jig for a gastrostomy catheter according to claim 7, wherein the position of the connection point between the second wall portion and the other wall portion of the mounting portion is higher than the position of the connection point between the first wall portion and the one wall portion of the mounting portion.
9. An insertion jig for a gastrostomy catheter according to any one of claims 5 to 8, wherein the thickness of the edge of the insertion hole in the tip occlusion portion is greater than the thickness of the mounting portion.
10. The insertion jig for a gastrostomy catheter according to claim 9, wherein the thickness of the mounting portion is 0.3 mm or more and 0.6 mm or less.
11. The insertion jig for a gastrostomy catheter according to claim 9 or 10, wherein the thickness of the edge of the insertion hole in the tip occlusion portion is 0.8 mm or more.
12. An insertion device for a gastrostomy catheter according to any one of claims 1 to 11, The aforementioned gastrostomy catheter, A gastrostomy catheter kit equipped with [features / equipment].
Citation Information
Patent Citations
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