Gastrostomy catheter and capsule cover

The gastrostomy catheter's polygonal capsule cover with bulging corners addresses the challenge of sheath tearing, enabling smoother insertion and effective bumper deployment in the stomach.

JP2025146307APending Publication Date: 2025-10-03SB KAWASUMI LABORATORIES INC +1
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Patent Information

Application Number
JP2024047002
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Filing Date
2024-03-22
Publication Date
2025-10-03

AI Technical Summary

Technical Problem

The existing gastrostomy catheters face challenges in smoothly tearing the gastrostomy sheath during placement.

Method used

A gastrostomy catheter with a capsule cover having a polygonal cross-sectional shape and bulging corners is designed to facilitate smooth tearing of the gastrostomy sheath by pushing it outward along the breaking portion.

Benefits of technology

The capsule cover allows for more efficient and seamless insertion of the gastrostomy catheter by ensuring the sheath is torn smoothly, reducing insertion resistance and ensuring proper placement of the bumper in the stomach.

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Abstract

To provide a gastrostomy catheter that allows a sheath for gastrostomy to be torn more smoothly by a capsule cover.SOLUTION: A gastrostomy catheter 100 includes: a catheter body 1 having a shaft 10 equipped with a lumen 11 and a body surface abutment part; a bumper 50 provided in the lower end part of the shaft 10, which expands in the stomach; and a capsule cover 70 for keeping the bumper 50 in a contracted state. At the time of detention, the capsule cover 70 is separated from the catheter body 1 and the bumper 50 expands. The cross-sectional shape of the contour of the capsule cover 70 is polygonal, and the contour protrudes outward in a corner part 75 of the polygon.SELECTED DRAWING: Figure 1
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Description

[Technical Field]

[0001] The present invention relates to a gastrostomy catheter and a capsule cover. [Background technology]

[0002] An example of a gastrostomy catheter is described in Patent Document 1. The gastrostomy catheter in Patent Document 1 comprises a catheter body having a shaft with a lumen and a body surface contact portion, a bumper that is provided at the lower end of the shaft and expands inside the stomach, and a capsule cover that maintains the bumper in a contracted state; when the catheter is placed, the capsule cover detaches from the catheter body and the bumper expands, and the capsule cover has a circular cross-sectional outer shape. When placing a gastrostomy catheter, the capsule cover and the lower end of the shaft of the gastrostomy catheter first tear the gastrostomy sheath placed in the fistula, and then penetrate the gastrostomy sheath and the fistula into the stomach. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Japanese Patent Application Publication No. 2019-98146 Summary of the Invention [Problem to be solved by the invention]

[0004] According to the investigations of the present inventors, the gastrostomy catheter of Patent Document 1 still has room for improvement in terms of the configuration in which the capsule cover tears the gastrostomy sheath more smoothly.

[0005] The present invention has been made in view of the above problems, and provides a gastrostomy catheter and a capsule cover that enable a gastrostomy sheath to be torn more smoothly by the capsule cover. [Means for solving the problem]

[0006] According to the present invention, there is provided a gastrostomy catheter comprising: a catheter body having a shaft with a lumen and a body surface abutment portion; a bumper provided at the lower end of the shaft and expanding within the stomach; and a capsule cover that maintains the bumper in a contracted state, wherein the capsule cover detaches from the catheter body and the bumper expands when the catheter is placed, and wherein the outer cross section of the capsule cover is polygonal, and the outer shape bulges outward at the corners of the polygonal shape.

[0007] According to the present invention, there is also provided a capsule cover for a gastrostomy catheter, the capsule cover comprising: a catheter body having a shaft with a lumen and a body surface abutment portion; a bumper provided at the lower end of the shaft and expanding within the stomach; and a capsule cover for maintaining the bumper in a contracted state, wherein the capsule cover detaches from the catheter body during placement, causing the bumper to expand, The capsule cover has a polygonal cross-sectional shape, The outer shape is provided with a capsule cover that bulges outward at the corners of the polygonal shape. [Effects of the Invention]

[0008] According to the present invention, the capsule cover allows the gastrostomy sheath to be torn more smoothly. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 is a perspective view of a gastrostomy catheter according to an embodiment. [Figure 2] FIG. 1 is a longitudinal cross-sectional view of a gastrostomy catheter according to an embodiment. [Figure 3] FIG. 3(a) is a perspective view of a gastrostomy sheath according to an embodiment, and FIG. 3(b) is a longitudinal cross-sectional view of the gastrostomy sheath according to an embodiment. [Figure 4] 1A and 1B are diagrams showing a gastrostomy catheter and a gastrostomy sheath according to an embodiment, in which the gastrostomy catheter is shown in a front view and the gastrostomy sheath is shown in a perspective view. [Figure 5]10 shows an embodiment of a capsule cover pushed into a gastrostomy sheath. [Figure 6] FIG. 10 is a diagram for explaining the operation when placing a gastrostomy catheter according to an embodiment, showing the state before the gastrostomy catheter is inserted into the gastrostomy sheath placed in the fistula. [Figure 7] FIG. 10 is a diagram for explaining the operation when placing a gastrostomy catheter according to an embodiment, showing the gastrostomy catheter with an obturator attached inserted into the fistula. [Figure 8] 8(a) and 8(b) are diagrams for explaining placement of a gastrostomy catheter according to an embodiment. Of these, FIG. 8(a) shows a state in which the inner tubular part is pushed downward relative to the outer tubular part, and FIG. 8(b) shows a state in which the obturator has been removed from the gastrostomy catheter. [Figure 9] FIG. 2 is a perspective view of a capsule cover according to an embodiment. [Figure 10] FIG. 2 is a cross-sectional view of a capsule cover according to an embodiment. [Figure 11] Figures 11(a) and 11(b) are plan views of a capsule cover in an embodiment, and in Figure 11(a) imaginary circumscribing lines are shown with dashed double-dot lines, and in Figure 11(b) imaginary regular polygons are shown with dashed double-dot lines. DETAILED DESCRIPTION OF THE INVENTION

[0010] Hereinafter, each embodiment of the present invention will be described with reference to the drawings. In all drawings, similar components are given the same reference numerals, and descriptions thereof will be omitted where appropriate. Note that Fig. 2 and Figs. 6 to 8(b) are cross-sectional views taken along the axial direction of the shaft 10. Fig. 3(b) is a cross-sectional view taken along the axial direction of the gastrostoma sheath 300. Furthermore, the various components of the gastrostomy catheter 100 of the present invention do not need to be independent entities. It is acceptable for multiple components to be formed as a single member, for one component to be formed from multiple members, for one component to be part of another component, or for part of one component to overlap with part of another component, etc. 2 will be referred to as "downward" and "upward" in the following description. The axial direction of the shaft 10 will sometimes be referred to simply as the "axial direction," and the radial direction of the shaft 10 will sometimes be referred to simply as the "radial direction." The circumferential direction of the shaft 10 will sometimes be referred to simply as the "circumferential direction."

[0011] The gastrostomy catheter 100 according to this embodiment comprises a catheter body 1 having a shaft 10 with a lumen 11 and a body surface contact portion, a bumper 50 provided at the lower end of the shaft 10 that expands within the stomach, and a capsule cover 70 that maintains the bumper 50 in a contracted state; when the catheter is placed, the capsule cover 70 detaches from the catheter body 1 and the bumper 50 expands. Here, as shown in Figures 9, 10, 11(a) and 11(b), the cross-sectional shape of the outer shape of the capsule cover 70 is polygonal, and the outer shape bulges outward (opposite the center of the capsule cover 70 in the radial direction) at the corners 75 of the polygon. In the present invention, the outer shape of the capsule cover 70 does not have to bulge outward at all of the multiple corners 75, but only needs to bulge outward at at least one of the multiple corners 75. In this case, "bulging outward" means that a side portion 76 (described in detail below) between the two corners 75 is recessed inward (toward the center of the capsule cover 70 in the radial direction) from a common imaginary circumscribing line (for example, a circumscribing line 601 shown in FIG. 11(a)) between the corner 75 where the outer shape of the capsule cover 70 bulges and another corner 75 adjacent to the corner 75. In the present embodiment, as an example, the outer shape of the capsule cover 70 bulges outward at all of the multiple corners 75. That is, each of the multiple side portions 76 is recessed inward from the corresponding circumscribing lines 601 to 606. Furthermore, in this case, the outer shape of the capsule cover 70 bulges outward from a virtual regular polygon (in this embodiment, a regular hexagon indicated by a two-dot chain line 620 (see FIG. 11(b))) formed by the inscribing lines of each side portion 76 of the outer shape of the capsule cover 70.

[0012] Before the gastrostomy catheter 100 is placed, the bumper 50 is housed inside the capsule cover 70 in a contracted state (folded state) in which it is contracted in the radial direction. When placing the gastrostomy catheter 100, first, the lower end of the shaft 10 is inserted into the lumen of the fistula 530 formed by penetrating the abdominal wall 510 and the stomach wall 520, and the bumper 50 is placed in the stomach. With the bumper 50 placed at a desired position in the stomach, the capsule cover 70 is detached from the bumper 50 using an insertion tool (for example, the obturator 200 shown in Figures 4 and 5, etc.), causing the bumper 50 to expand radially due to its elastic restoring force and become engaged with the stomach wall 520. This allows the gastrostomy catheter 100 to be placed.

[0013] In this embodiment, the capsule cover 70 and the lower end of the shaft 10 are inserted into the fistula 530 through the lumen of the gastrostoma sheath 300 (see FIGS. 3(a) to 4) which is first placed in the fistula 530. More specifically, the gastrostoma sheath 300 has a breaking portion 350 extending in the axial direction of the gastrostoma sheath 300, and when the capsule cover 70 is pushed into the gastrostoma sheath 300, the gastrostoma sheath 300 tears along the breaking portion 350 (see FIG. 5). As a result, the capsule cover 70 and the lower end of the shaft 10 of the gastrostoma catheter 100 tear the gastrostoma sheath 300 along the breaking portion 350, and penetrate the gastrostoma sheath 300 and ultimately the fistula 530 to reach the stomach.

[0014] According to this embodiment, the capsule cover 70 has a polygonal cross-sectional shape, and the outer shape bulges outward at the corners 75 of the polygon. As a result, when the capsule cover 70 is pushed in, the polygonal corners 75 can push the gastrostoma sheath 300 outward in the radial direction. Therefore, the capsule cover 70 can smoothly tear the gastrostoma sheath 300 along the tearing portion 350.

[0015] The gastrostomy catheter 100 will be described in more detail below. In this embodiment, the inner cavity of the shaft 10 forms a lumen 11 . 1 and 2, the shaft 10 is formed in a cylindrical shape with its axial direction extending in the vertical direction. The outer diameter of the upper end of the shaft 10 is relatively larger than the outer diameter of the other parts of the shaft 10. A coupled part 30, which will be described later, is attached to the upper end of the shaft 10. The inner diameter of the upper end of the lumen 11 (the inner diameter of the upper end of the shaft 10) is, for example, relatively larger than other parts of the lumen 11, and forms a storage section in which the check valve 40 described later is stored. A wire lumen 12 is formed inside the tube wall of the shaft 10. One longitudinal end of the wire lumen 12 opens at the lower end of the shaft 10 and communicates with the inside of the bumper 50. The wire lumen 12 is disposed at a position offset radially outward from the lumen 11. A wire (not shown) for deploying the bumper 50 is inserted through the wire lumen 12.

[0016] 7, the body surface contact portion 20 is the portion exposed to the body surface of the living body when the gastrostomy catheter 100 is indwelling, and the lower surface of the body surface contact portion 20 faces the outer surface of the abdominal wall 510. The lower surface of the body surface contact portion 20 is formed flat. For example, a plug member 80 (see FIG. 1) is formed on the body surface contact portion 20. The plug member 80 is capable of closing an opening 31 on the upper end side of the connectable portion 30, which will be described below.

[0017] The shaft 10 and the body surface contact portion 20 are integrally molded from, for example, a resin material. The resin material is not particularly limited, but examples thereof include polyvinylidene fluoride resin, polytetrafluoroethylene resin, polyethylene resin, polypropylene resin, silicone rubber, and other rubber materials.

[0018] In this embodiment, as shown in FIGS. 1 and 2, the gastrostomy catheter 100 further includes a connection receiving portion 30 formed at the upper end of the body surface contact portion 20. The obturator 200 described above is detachably hooked to the connected portion 30. This allows the obturator 200 to be attached to the gastrostomy catheter 100. The coupled part 30 is formed, for example, in a flat tubular shape with an axial dimension smaller than its radial dimension. The coupled part 30 includes a cylindrical main body 30b and an inner flange 30a that protrudes radially inward from the upper end of the main body 30b. The inner peripheral edge of the inner flange 30a defines an opening 31 at the upper end of the coupled part 30. A pair of recesses 32 are formed on the outer peripheral surface of the main body 30b. The claws of the obturator 200 engage with the recesses 32, respectively, whereby the obturator 200 is attached to the gastrostomy catheter 100.

[0019] As shown in FIG. 2 and other figures, the gastrostomy catheter 100 further includes a check valve 40 provided at the upper end of the lumen 11. The check valve 40 is fitted into the inner cavity of the upper end of the lumen 11, for example. The check valve 40 has a valve port that opens and closes between an open state and a closed state. In the present embodiment, the check valve 40 is, for example, a duckbill valve. In the normal state, the valve opening of the check valve 40 is closed, blocking the opening at the upper end of the lumen 11. In this way, the check valve 40 prevents stomach contents from flowing back out of the body from the stomach. On the other hand, when nutrients or the like are injected into the stomach via the gastrostomy catheter 100, the valve opening is in an open state, connecting the lumen 11 to the outside of the body, thereby allowing the check valve 40 to pass nutrients from the outside of the body into the stomach.

[0020] 2, the capsule cover 70 is formed, for example, in a cylindrical shape with a bottom and an axial direction extending in the vertical direction. The capsule cover 70 has, for example, a cylindrical mounting portion 72 that is mounted to the lower end of the shaft 10, and a tip closing portion 73 that closes the lower end of the mounting portion 72. The tip closing portion 73 is formed in a shape that bulges downward. The distal end closing portion 73 of the capsule cover 70 is formed with an insertion hole 74 through which a guide wire (not shown) is inserted vertically. The insertion hole 74, for example, passes vertically through the tip blocking portion 73. The axial center of the insertion hole 74, for example, coincides with the axial center of the mounting portion 72. The outer diameter of the insertion hole 74 is, for example, approximately constant regardless of the position in the axial direction.

[0021] As described above, the cross-sectional shape of the outer shape of the capsule cover 70 is polygonal. More specifically, in this embodiment, the cross-sectional shape of the outer shape of the mounting portion 72 of the capsule cover 70 is approximately hexagonal, and the outer shape bulges outward at six corners 75. Similarly, the cross-sectional shape of the outer shape of the distal end closing portion 73 of the capsule cover 70 is also approximately hexagonal. However, the outer dimensions of the hexagonal shape of the distal end closing portion 73 gradually decrease downward. More specifically, the amount of bulging at each corner 75 of the outer shape of the distal end closing portion 73 gradually decreases. On the other hand, the outer dimensions of the hexagonal shape of the mounting portion 72 are approximately constant regardless of the axial position. More specifically, the amount of bulging at each corner 75 of the outer shape of the mounting portion 72 is approximately constant regardless of the axial position. In this embodiment, each corner 75 is formed continuously from the upper end of the capsule cover 70 to the vicinity of the insertion hole 74 . 10, the outer shape of the capsule cover 70 is a generally arc-shaped convex radially outward at each corner 75. In addition, the outer shape of the capsule cover 70 is a generally arc-shaped concave radially inward at side portions 76 between the corners 75. Here, the radius of curvature of the outer shape of the capsule cover 70 at the corners 75 is smaller than the radius of curvature of the outer shape of the capsule cover 70 at the side portions 76 . With this configuration, each corner 75 of the capsule cover 70 has a shape that bulges outward in the radial direction, and these corners 75 allow the gastrostoma sheath 300 to be smoothly torn along the breaking portion 350.

[0022] When inserting the gastrostomy catheter 100 into the gastrostoma sheath 300, it is also preferable to position the capsule cover 70 relative to the sheath body 310 so that, for example, one of the corners 75 is pushed along the breaking portion 350. By doing so, when the capsule cover 70 is pushed into the gastrostoma sheath 300, the corners 75 can smoothly tear the gastrostoma sheath 300 along the breaking portion 350.

[0023] The material constituting the capsule cover 70 is not particularly limited, but examples thereof include edible cellulose-based or gelatin-based materials, and materials that are decomposed in the body, such as polylactic acid.

[0024] In this embodiment, the thickness of the capsule cover 70 (thickness T1 shown in FIG. 10) is greatest at the corners 75. With this configuration, as described above, the capsule cover 70 can be configured to have locally thicker portions (corner portions 75) at multiple locations in the circumferential direction than other portions of the capsule cover 70. The portions (corner portions 75) that are thicker than other portions of the capsule cover 70 ensure sufficient rigidity, and these corner portions 75 allow the gastrostoma sheath 300 to tear more smoothly along the rupture portion 350. More specifically, the maximum thickness T1 of the capsule cover 70 is preferably 1.1 to 4.0 times the minimum thickness T2 of the capsule cover 70, and more preferably 1.3 to 3.2 times the minimum thickness T2. Furthermore, the maximum wall thickness T1 of the capsule cover 70 is greater than, for example, the wall thickness of the sheath body 310 of the gastrostoma sheath 300. More specifically, from the viewpoint of realizing a configuration in which the capsule cover 70 tears the gastrostoma sheath 300 more smoothly, the maximum wall thickness T1 of the capsule cover 70 is preferably, for example, 1.0 to 7.0 times the wall thickness of the sheath body 310 of the gastrostoma sheath 300, and more preferably 2.5 to 5.3 times the wall thickness of the sheath body 310.

[0025] In this embodiment, the outer cross-sectional shape of the capsule cover 70 is polygonal as described above, while the inner cavity of the capsule cover 70 has a circular cross-sectional shape. Note that the circular shape here may be a perfect circle or an elliptical shape that is elongated in one direction. This allows the gastrostoma sheath 300 to be smoothly torn by the corners 75, while also allowing the inner cavity of the capsule cover 70 to have a circular shape that corresponds to the cross-sectional shape of the shaft 10. This allows the capsule cover 70 to fit well around the lower end of the shaft 10. That is, it is possible to realize a configuration in which the capsule cover 70 tears the gastrostoma sheath 300 more smoothly, and a configuration in which the capsule cover 70 is prevented from falling off the catheter main body 1 at an unintended timing. More specifically, the cross-sectional shape of the cavity of the attachment portion 72 of the capsule cover 70 is circular. Similarly, the cross-sectional shape of the cavity of the distal end closing portion 73 of the capsule cover 70 is also circular. However, the circular inner diameter of the distal end closing portion 73 gradually decreases downward. On the other hand, the circular inner diameter of the attachment portion 72 is approximately constant regardless of the position in the axial direction.

[0026] In this embodiment, the maximum outer diameter R1 of the capsule cover 70 shown in Figure 10 (the distance between the vertices of each corner portion 75 facing each other in the radial direction) is preferably 9.0 mm or more and 11.0 mm or less, and more preferably 10.0 mm or more and 10.6 mm or less. Furthermore, the minimum outer diameter R2 (the distance between the vertices of the side portions 76 facing each other in the radial direction) of the capsule cover 70 shown in FIG. 10 is preferably 8.0 mm or more and 10.0 mm or less, and more preferably 9.0 mm or more and 9.6 mm or less. With this configuration, the capsule cover 70 can be inserted into the lumen of the gastrostoma sheath 300, and when the capsule cover 70 is inserted into the lumen of the gastrostoma sheath 300, the corners 75 can smoothly tear the gastrostoma sheath 300. The maximum inner diameter of the capsule cover 70 is preferably 7.0 mm or more and 9.0 mm or less, and more preferably 8.0 mm or more and 8.25 mm or less. With this configuration, the capsule cover 70 can be fitted well to the lower end of the shaft 10.

[0027] As described above, the capsule cover 70 according to this embodiment is a capsule cover 70 for a gastrostomy catheter that includes a catheter main body 1 having a shaft 10 with a lumen 11 and a body surface abutment portion 20, a bumper 50 that is provided at the lower end of the shaft 10 and expands within the stomach, and a capsule cover 70 that maintains the bumper 50 in a contracted state, and that detaches from the catheter main body when placed, causing the bumper 50 to expand. The capsule cover 70 has a polygonal cross-sectional shape, and the outer shape bulges outward at corners 75 of the polygon.

[0028] The bumper 50 is formed, for example, in a substantially annular bag shape in a plan view, and is open, for example, upward. The bumper 50 is flexible and can be expanded in the radial direction. A portion of a wire (not shown) is arranged in a coiled manner inside the bumper 50. One end of the wire is introduced into the bumper 50 through the above-mentioned wire lumen 12 (see FIG. 2, etc.) formed in the shaft 10. As described above, before the gastrostomy catheter 100 is placed, the bumper 50 is folded and housed inside the capsule cover 70. When the capsule cover 70 is detached from the bumper 50 by the obturator 200, the bumper 50 expands radially due to the elastic restoring force of the wire and is locked to the stomach wall 520. When the wire inside the bumper 50 is removed from the bumper 50 from this state, the bumper 50 contracts radially and is released from the locking of the bumper 50 to the stomach wall 520. The outer surface of the bumper 50 is, for example, textured, which more reliably prevents the outer surfaces of the bumper 50 from sticking together when the bumper 50 is folded and housed in the capsule cover 70.

[0029] Next, the gastrostomy sheath 300 will be described in more detail. As shown in Figures 3(a) and 3(b), the gastrostoma sheath 300 includes, for example, a sheath body 310 into which the capsule cover 70 and the lower end of the shaft 10 are inserted, and a gripping portion 320 provided on the upper end side of the sheath body 310. The sheath body 310 is formed in a substantially cylindrical shape with its axial direction extending in the vertical direction. The upper end of the sheath body 310 forms an expanded diameter section 315 that has a diameter relatively larger than that of the remaining portions of the sheath body 310. More specifically, a circumferential portion of the expanded diameter section 315 expands radially outward. The maximum inner diameter of the expanded diameter section 315 is larger than the inner diameter of the remaining portions of the sheath body 310, and the maximum outer diameter of the expanded diameter section 315 is larger than the outer diameter of the remaining portions of the sheath body 310. The opening on the upper end side of the sheath body 310 (the opening of the expanded diameter portion 315) is, for example, a downwardly inclined oblique cut. The grip portion 320 is a portion that is gripped by the practitioner when inserting the gastrostomy catheter 100. The grip portion 320 is formed in the shape of a tongue that extends from the opening on the upper end side of the sheath body 310. The gripping portion 320 includes a first member 321 and a second member 322, each of which is formed in a plate shape. The gripping portion 320 is fixed to the sheath body 310 such that the upper end of the sheath body 310 is sandwiched between the lower end of the first member 321 and the lower end of the second member 322.

[0030] 3(a), the breaking portion 350 is formed in the sheath body 310. The breaking portion 350 extends along the longitudinal direction (axial direction) of the sheath body 310. The breaking portion 350 may be a portion where the wall thickness of the sheath body 310 is locally reduced by a cut groove extending along the longitudinal direction of the sheath body 310, or may be a slit that penetrates the sheath body 310 in the wall thickness direction. The break 350 can be formed by, for example, laser processing or machining.

[0031] The minimum inner diameter of the sheath body 310 is smaller than the maximum outer diameter of the capsule cover 70 . As a result, when the capsule cover 70 (i.e., the portion having an outer diameter larger than the minimum inner diameter of the sheath body 310) attempts to pass through the sheath body 310, the sheath body 310 is pushed radially outward by the portion and is split vertically along the breaking portion 350.

[0032] The material from which the sheath body 310 is made is not particularly limited, but preferable examples include polyethylene resin, polypropylene resin, polytetrafluoroethylene resin (PTFE), tetrafluoroethylene-hexafluoropropylene copolymer (FEP), tetrafluoroethylene-ethylene copolymer (ETFE), etc. Of these, a fluororesin with low frictional resistance is more preferable, as this reduces the frictional resistance encountered when passing through the lumen of the sheath body 310 during insertion of the gastrostomy catheter 100, thereby reducing the insertion resistance of the gastrostomy catheter 100.

[0033] 5 to 8(b), an example of a method of using the gastrostomy catheter 100 will be described. Note that the description will start from a state in which a fistula 530, into which the gastrostomy catheter 100 is inserted, is formed by penetrating the abdominal wall 510 and the stomach wall 520, and a gastrostomy sheath 300 has been inserted into the fistula 530 in advance.

[0034] First, the obturator 200 is attached to the gastrostomy catheter 100 by connecting the obturator 200 to the connection receiving portion 30 . Next, as shown in Fig. 6, the capsule cover 70 and the lower end of the shaft 10 are inserted (pushed downward) into the fistula 530 through the lumen of the gastrostoma sheath 300 placed in the fistula 530. At this time, the gastrostoma sheath 300 is pushed outward in the radial direction by the capsule cover 70, and the sheath body 310 is split vertically along the breaking portion 350 (see Fig. 5). As a result, the lower end of the shaft 10 of the gastrostomy catheter 100 penetrates the sheath body 310 and reaches the stomach, and the bumper 50 is placed inside the stomach. In this state, the body surface abutting portion 20 and the portion of the gastrostomy catheter 100 above the body surface abutting portion 20 are placed along the body surface. Then, the gastrostomy sheath 300 that has split along the breaking portion 350 is removed from the body (see FIG. 7). As described above, the capsule cover 70 has a polygonal cross-sectional shape, and the outer shape bulges outward at the corners 75 of the polygon. As a result, when the capsule cover 70 is pushed in, the polygonal corners 75 can push the gastrostoma sheath 300 outward in the radial direction. Therefore, the capsule cover 70 can smoothly tear the gastrostoma sheath 300 along the tearing portion 350.

[0035] Next, as shown in Figure 8(a), the inner tubular portion 230 of the obturator 200 is pushed downward relative to the outer tubular portion 220. As a result, the lower end of the inner tubular portion 230 presses the capsule cover 70 downward, the capsule cover 70 is detached from the bumper 50, and the bumper 50 is expanded. As a result, the bumper 50 is engaged with the stomach wall 520, and the gastrostomy catheter 100 is placed. Once the gastrostomy catheter 100 is placed, the connection of the obturator 200 to the connectable portion 30 is released, and the obturator 200 is removed from the gastrostomy catheter 100 (see Figure 8(b)). Furthermore, when removing the gastrostomy catheter 100 from the fistula 530, the wire is pulled out from the wire lumen 12 and therefore from the bumper 50. This causes the bumper 50 to contract radially, releasing the bumper 50 from its engagement with the stomach wall 520. This allows the gastrostomy catheter 100 to be removed from the stomach.

[0036] The present invention is not limited to the above-described embodiments, but includes various modifications and improvements as long as the object of the present invention is achieved.

[0037] The present embodiment encompasses the following technical ideas. (1) A gastrostomy catheter comprising: a catheter body having a shaft with a lumen and a body surface contact portion; a bumper provided at the lower end of the shaft and expanding within the stomach; and a capsule cover that maintains the bumper in a contracted state; wherein the capsule cover detaches from the catheter body during placement, causing the bumper to expand; The capsule cover has a polygonal cross-sectional shape, The gastrostomy catheter has an outer shape in which corners of the polygonal shape bulge outward. (2) The gastrostomy catheter according to (1), wherein the thickness of the capsule cover is greatest at the corners. (3) The gastrostomy catheter according to (1) or (2), wherein the cross-sectional shape of the lumen of the capsule cover is circular. (4) A capsule cover for a gastrostomy catheter, comprising: a catheter body having a shaft with a lumen and a body surface contact portion; 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, wherein the capsule cover detaches from the catheter body during placement, causing the bumper to expand, The capsule cover has a polygonal cross-sectional shape, The capsule cover has an outer shape that bulges outward at the corners of the polygonal shape. [Explanation of symbols]

[0038] 1. Catheter body 10 shaft 11 lumens 12 wire lumens 20 Body surface contact part 30 Connected part 30a Inner flange 30b Main body 31 Aperture 32 recess 40 Check valve 50 Bumper 70 Capsule Cover 72 Mounting part 73 Tip occlusion 74 Insertion hole 75 Corner 76 limbus 80 Plug member 100 Gastrostomy catheter 200 Obturator 210 Tubular body 220 Outer pipe section 230 Inner pipe section 240 Connection section 300 Gastrostomy sheath 310 Sheath body 315 Expanded diameter part 320 Gripping part 321 First member 322 Second member 350 Breaking part 510 Abdominal wall 520 Stomach wall 530 Fistula 601~606 External tangent 620 regular hexagon

Claims

1. A gastrostomy catheter comprising: a catheter body having a shaft with a lumen and a body surface abutment portion; a bumper provided at the lower end of the shaft and expanding within the stomach; and a capsule cover for maintaining the bumper in a contracted state, wherein the capsule cover detaches from the catheter body during placement, causing the bumper to expand; The capsule cover has a polygonal cross-sectional shape, The gastrostomy catheter has an outer shape in which corners of the polygonal shape bulge outward.

2. The gastrostomy catheter according to claim 1 , wherein the thickness of the capsule cover is greatest at the corners.

3. 3. The gastrostomy catheter according to claim 1, wherein the cross-sectional shape of the lumen of the capsule cover is circular.

4. A capsule cover for a gastrostomy catheter comprising: a catheter body having a shaft with a lumen and a body surface abutment portion; a bumper provided at the lower end of the shaft and expanding within the stomach; and a capsule cover for maintaining the bumper in a contracted state, wherein the capsule cover detaches from the catheter body and the bumper expands during placement, The capsule cover has a polygonal cross-sectional shape, The capsule cover has an outer shape that bulges outward at the corners of the polygonal shape.

Citation Information

Patent Citations

  • Gastric fistula catheter

    JP2019098146A