Indwelling support devices and indwelling support kits
The placement aid and kit facilitate the secure, single-stage insertion of a button-type gastrostomy catheter by pre-expanding the puncture site and using a second tip member to minimize stomach wall burden and accidental removal.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Filing Date
- 2025-07-04
- Publication Date
- 2026-07-07
Smart Images
Figure 2026113382000001_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to a retention aid and a retention aid kit.
Background Art
[0002] For patients who are unable to ingest food through the mouth due to a decline in swallowing function or the like, a method is known in which a gastrostomy catheter is placed in a penetration part that penetrates the abdominal wall and gastric wall of the patient, and nutrients, water, drugs, etc. are supplied into the stomach using the gastrostomy catheter (for example, Patent Document 1 below).
Prior Art Documents
Patent Documents
[0003]
Patent Document 1
Summary of the Invention
Problems to be Solved by the Invention
[0004] The gastrostomy catheter has a tubular catheter body disposed in a penetration part that penetrates the gastric wall and the abdominal wall. The lumen of the catheter body communicates between the inside of the stomach and the outside of the body, and nutrients and the like are supplied into the stomach through the lumen of the catheter body.
[0005] As types of gastrostomy catheters, there are a tube type in which the length of the catheter body exposed outside the body is relatively long, and an adapter for injecting nutrients and the like is connected to the outer end of the catheter body at the time of gastrostomy formation, and a button type in which the length of the catheter body exposed outside the body is relatively short, and a lid portion is provided at the outer end of the catheter body. The lid portion is formed with an opening communicating with the lumen of the catheter body, and is configured to be able to open and close this opening.
[0006] The gastrostomy catheter has an internal structure at the stomach-side end that prevents accidental removal of the catheter from the body. Gastrostomy catheters come in two types: balloon type, where the internal structure is a balloon, and bumper type, where the internal structure is a bumper. The balloon expands from a deflated state when a liquid such as distilled water is injected. The bumper expands when stretched longitudinally and can be expanded when the stretched state is released, or it does not expand or contract.
[0007] Because both tube-type and button-type gastrostomy catheters have variations in their internal structure—some with a balloon-type structure and others with a bumper-type structure—gastrostomy catheters can be broadly classified into four types.
[0008] The surgical procedure for inserting a gastrostomy catheter (gastrostomy) was historically performed as open surgery, but nowadays it is mostly done using an endoscope. The latter is called percutaneous endoscopic gastrostomy (PEG). Currently, PEG is mainly performed using two methods: the pull method and the introducer modification.
[0009] In general terms, the pull method is a method of inserting a gastrostomy catheter by pulling it from inside the stomach to the outside of the body. The gastrostomy catheter used in the pull method is a tube-bumper type. Before gastrostomy placement, the tip of the catheter body used in the pull method is equipped with a roughly conical tip member that tapers towards the tip and has relatively high rigidity. A loop wire is provided at the tip of the roughly conical tip member. A bumper is provided at the proximal end of the catheter body.
[0010] The pull method is performed under observation with a gastrostomy tube, following these steps: First, the stomach wall is fixed in two places around the planned site for gastrostomy, and a relatively small skin incision is made in the center. Next, the incision is punctured into the stomach with a double needle, in which the inner needle is inserted into the outer sheath. Next, the inner needle of the double needle is removed from the outer sheath, and a long, loop-shaped guidewire is inserted into the stomach from outside the body through the outer sheath. Next, while grasping one end of the loop-shaped guidewire with the forceps of the endoscope, the endoscope is withdrawn from the oral cavity, and the other end of the loop-shaped guidewire is led out of the body through the oral cavity. Next, the loop wire provided on the approximately conical tip of the gastrostomy catheter is connected to the one end of the led-out loop-shaped guidewire.
[0011] Next, the portion of the loop-shaped guidewire that is exposed outside the body is pulled out, and the entire loop-shaped guidewire is removed from the body. As a result, the gastrostomy catheter connected to the loop-shaped guidewire is led out of the body through the oral cavity, esophagus, and stomach, with the portion beyond the bumper being led out of the body. The tip of the gastrostomy catheter has a roughly conical tip member and is sharp, so it easily expands the puncture site of the double needle and easily penetrates the stomach wall and abdominal wall.
[0012] Next, after adjusting the bumper to be positioned correctly inside the stomach, the portion of the catheter body that is exposed outside the body is cut at an appropriate length from the surface of the abdominal wall, and the aforementioned adapter is attached to the cut end.
[0013] The advantage of the pull method is that it places less stress on the stomach wall. The reason is as follows: The gastrostomy catheter penetrates the stomach wall and abdominal wall in that order, expanding the puncture site from the stomach wall side toward the abdominal wall side. Because the abdominal wall, which is more rigid than the stomach wall, is in close contact with the outside of the flexible and highly extensible stomach wall, the gastrostomy catheter can suppress overstretching of the stomach wall as it expands the puncture site and penetrates the stomach wall and abdominal wall. This suppresses damage to the stomach wall. In addition, the number of suture sites between the stomach wall and abdominal wall can be limited to two.
[0014] On the other hand, a drawback of the pull method is that the portion of the gastrostomy catheter exposed outside the body is relatively long, which means that the patient may inadvertently pull out the gastrostomy catheter. For this reason, tube-bumper type gastrostomy catheters are often replaced with button-type gastrostomy catheters at an appropriate time after placement.
[0015] In contrast, the introducer modification, in general terms, involves pushing a dilator from the abdominal wall side toward the gastric wall side into the puncture site of a double needle to expand the puncture site and create a penetration site, into which a button-shaped gastrostomy catheter is inserted from the abdominal wall side and left in place. In the button-shaped gastrostomy catheter used in the introducer modification, the internal structure is an expandable and contractible bumper.
[0016] The introducer modification is performed under observation with a gastroscopy, following these steps: First, the stomach wall is fixed in three or four places around the planned site for gastrostomy, and a relatively large skin incision is made in the center. Next, the incision is punctured into the stomach with a double needle, in which the inner needle is inserted into the outer sheath. Next, the inner needle of the double needle is removed from the outer sheath, and a guidewire is inserted into the outer sheath. Next, the outer sheath is removed, and a dilator is inserted into the puncture site from outside the body along the guidewire to expand the puncture site to the extent that the gastrostomy catheter can pass through, or to weaken the surrounding tissue and create a penetration site that facilitates insertion of the gastrostomy catheter. Next, the dilator is removed. Next, with the bumper contracted, the gastrostomy catheter is guided along the guidewire, and the bumper is inserted into the stomach through the penetration site. Next, the bumper is expanded inside the stomach.
[0017] The advantages of the introducer modification are that PEG becomes possible even if there is some stenosis in the esophagus, etc., as long as a thin endoscope can pass through, and that a button-type gastrostomy catheter can be placed from the beginning (in a single stage).
[0018] On the other hand, a drawback of the introducer modification is that it places a greater burden on the stomach wall compared to the pull method. Unlike the pull method, dilators and button-type gastrostomy catheters are inserted into the puncture site from the abdominal wall towards the stomach wall. Therefore, the stomach wall is overstretched by the dilator or gastrostomy catheter, with the stomach wall fixation point acting as a fulcrum, which is thought to place a greater burden on the stomach wall compared to the pull method.
[0019] The objective of the embodiments of the present invention is to provide a placement aid and placement aid kit that allow for the placement of a button-type gastrostomy catheter in a single stage in a manner that places minimal burden on the stomach wall. [Means for solving the problem]
[0020] (1) An indwelling aid according to an embodiment of the present invention is an indwelling aid used when a button-shaped gastrostomy catheter, comprising a catheter body having a lumen formed therein and an expandable and contractible expander provided at one end of the catheter body, is placed in a penetration site that penetrates the stomach wall and abdominal wall, It has flexibility and a long shaft, A base provided at the tip of the aforementioned shaft, A first tip member that is detachable from the base and has a tapered portion that narrows from the base end to the tip end and a loop wire provided at the tip of the tapered portion, A second tip member is provided, which can be attached to the base in place of the first tip member, and which has a storage space formed therein that allows the expanded body of the gastrostomy catheter in a contracted state to be inserted from the tip side and accommodated. It is equipped with.
[0021] (2) The retaining aid of (1) above, wherein the tip of the shaft is provided with a scale along the axial direction of the shaft.
[0022] (3) The implantation aid according to (1) or (2) above, wherein the diameter of the tip of the shaft gradually decreases from the tip side toward the base side, and the diameter of the portion of the shaft closer to the base side than the tip is smaller than the diameter of the tip of the shaft.
[0023] (4) The first tip member and the second tip member are each a retention aid according to any one of (1) to (3) above, which are attached to the pedestal by screwing into the pedestal.
[0024] (5) The proximal end portion of the first tip member is hexagonal when viewed from the axial direction of the shaft, and is the retention aid according to (4) above.
[0025] (6) A retention aid according to any one of (1) to (5) above, a rod that can be inserted into the inner cavity of the gastrostomy catheter and has a length of the portion that can be inserted into the inner cavity longer than the sum of the total length of the gastrostomy catheter and the depth of the accommodation space, and a retention aid kit.
[0026] (7) Further comprising a spacer having elasticity and capable of being attached to the outer peripheral surface of the catheter body of the gastrostomy catheter, wherein a through-hole for arranging the catheter body and a slit extending radially outward from the through-hole are formed in the spacer, and it is the retention aid kit according to (6) above.
[0027] (8) In a state where the rod is inserted into the inner cavity of the gastrostomy catheter housed in the second tip member, male threads are formed on at least the outer peripheral surface of the portion of the rod exposed from the gastrostomy catheter, and further comprising an annular member having female threads formed on the inner peripheral surface thereof to be screwed with the male threads, and it is the retention aid kit according to (6) or (7) above.
Advantages of the Invention
[0028] Using the indwelling aid and indwelling aid kit according to the embodiment of the present invention, the following method of inserting a button-type gastrostomy catheter can be realized. One end of the loop-shaped guidewire is led out of the body from the oral cavity in a manner similar to the pull method. Next, the loop wire of the first tip member, which is attached to the base, is connected to one end of the loop-shaped guidewire. This connects the loop-shaped guidewire and the indwelling aid with the first tip member attached. Next, the portion of the loop-shaped guidewire that is exposed outside the body is pulled, and the entire loop-shaped guidewire is removed from the body. This leads the first tip member out of the body via the oral cavity, esophagus, and stomach.
[0029] The tip of the first tip member is provided with a sharp, tapered portion, allowing it to easily expand the puncture site and penetrate the stomach wall and abdominal wall to form a penetration. The first tip member penetrates the stomach wall and abdominal wall in this order. The abdominal wall, which is more rigid than the stomach wall, is in close contact with the outside of the flexible and highly extensible stomach wall, so when the first tip member expands the puncture site and penetrates the stomach wall and abdominal wall, it is possible to suppress overstretching of the stomach wall. This suppresses damage to the stomach wall. Therefore, the burden on the stomach wall can be reduced.
[0030] Next, the second tip member is attached to the base in place of the first tip member, and the contracted expanded body of the gastrostomy catheter is inserted into the housing space of the second tip member from the tip side. This mounts the gastrostomy catheter to the second tip member. Then, the second tip member, together with the gastrostomy catheter, is pushed in from the abdominal wall side toward the stomach wall side, thereby positioning the gastrostomy catheter at the penetration site.
[0031] The puncture site is pre-expanded using the first tip member to form a penetration point, and the second tip member is pushed into the stomach while maintaining the expanded state of the penetration point. Therefore, the burden on the stomach wall when pushing the second tip member and gastrostomy catheter from the abdominal wall side to the stomach wall side can be reduced compared to the introducer modification method. Next, the expandable body of the gastrostomy catheter is expanded inside the stomach. Then, the part of the shaft that is exposed outside the body is pulled, and the indwelling aid with the second tip member attached is removed from the body. This allows a button-type gastrostomy catheter to be placed in a single procedure.
[0032] Based on the above, according to embodiments of the present invention, it is possible to provide a placement aid and placement aid kit that allow a button-type gastrostomy catheter to be placed in a single stage in a manner that places less burden on the stomach wall. [Brief explanation of the drawing]
[0033] [Figure 1] This is a plan view showing an implantation support kit according to an embodiment. [Figure 2] This is a partial cross-sectional view showing a gastrostomy catheter according to an embodiment. [Figure 3] Figure 1 is a perspective view showing the second tip member of the implantation aid in the implantation aid kit. [Figure 4] This is a schematic diagram illustrating how to place a gastrostomy catheter at the penetration site through the stomach wall and abdominal wall. [Figure 5] This is a schematic diagram showing how to place a gastrostomy catheter at the insertion site. [Figure 6] This is a schematic diagram showing a gastrostomy catheter placed in the penetration site. [Figure 7] This is a perspective view showing a modified example of the embodiment of the retaining aid. [Figure 8] This is a plan view showing a modified example of the embodiment of the implantation support kit. [Figure 9] Figure 8 is a schematic diagram illustrating how to place a gastrostomy catheter in a penetration site that goes through the stomach wall and abdominal wall using the rod and annular member provided in the indwelling support kit. [Figure 10]Figure 8 is a schematic diagram illustrating how to place a gastrostomy catheter in a penetration site that goes through the stomach wall and abdominal wall using the rod and annular member provided in the indwelling support kit. [Modes for carrying out the invention]
[0034] Embodiments and modifications of the present invention will be described below with reference to the drawings. Note that the following description does not limit the technical scope or the meaning of terms as defined in the claims. Furthermore, the dimensional ratios in the drawings are exaggerated for illustrative purposes and may differ from actual ratios.
[0035] <Embodiment> Figure 1 is a plan view showing the implantation support kit 100 according to this embodiment. Figure 2 is a partial cross-sectional view showing the gastrostomy catheter 10 according to this embodiment. Figure 3 is a perspective view showing the second tip member 114 of the implantation aid 110 in the implantation aid kit 100 shown in Figure 1. Figure 4 is a schematic diagram showing a method for placing a gastrostomy catheter 10 in a penetration W0 that penetrates the stomach wall W2 and the abdominal wall W1. Figure 5 is a schematic diagram showing a method for placing the gastrostomy catheter 10 in the penetration site W0. Figure 6 is a schematic diagram showing a gastrostomy catheter 10 placed in the penetration W0.
[0036] The indwelling support kit 100 shown in Figure 1 is used to insert a button-shaped gastrostomy catheter 10 into a penetration W0 that penetrates the abdominal wall W1 and gastric wall W2 of patient H0, as shown in Figures 4 to 6. Before describing the indwelling support kit 100, the gastrostomy catheter 10 will be described below.
[0037] In this embodiment, the gastrostomy catheter 10 is a button-balloon type gastrostomy catheter 10. Referring to Figure 2, the gastrostomy catheter 10 comprises a flexible catheter body 11, an expandable and contractible expander 12 provided at one end of the catheter body 11, and a lid 13 provided at the other end of the catheter body 11.
[0038] The catheter body 11 is positioned in the penetration W0 as shown in Figure 6. As shown in Figure 2, the catheter body 11 comprises an outer tube 11a and an inner tube 11b positioned within the lumen of the outer tube 11a. Hereinafter, the direction in which the catheter body 11 extends will be referred to as the "longitudinal direction," and the direction intersecting the longitudinal direction will be referred to as the "radial direction." One end 11d (the end on the inside of the stomach) of the inner tube 11b in the longitudinal direction protrudes from one end 11e (the end on the inside of the stomach) of the outer tube 11a in the longitudinal direction. Nutritional supplements, water, drugs, etc. are supplied into the stomach H3 through the lumen 11c of the inner tube 11b.
[0039] In this embodiment, the expander 12 is composed of a balloon. As shown in Figure 6, the expander 12 is positioned in an expanded state inside the stomach H3 and functions as an internal stopper to prevent the gastrostomy catheter 10 from being pulled out of the body through the penetration W0. As shown in Figure 2, one end 12a in the longitudinal direction of the expander 12 is joined to one end (the end on the inside of the stomach) 11d in the longitudinal direction of the inner tube 11b, and the other end 12b in the longitudinal direction of the expander 12 is connected to one end (the end on the inside of the stomach) 11e in the longitudinal direction of the outer tube 11a. When an expanding liquid such as distilled water is injected into the expander 12 from the space 11f between the outer tube 11a and the inner tube 11b, the expander 12 expands radially.
[0040] As shown in Figure 6, the lid portion 13 is positioned outside the body and has the function of switching between a state in which the outside of the body and the inside of the stomach H3 are in communication and a state in which communication between the outside of the body and the inside of the stomach is blocked, and also functions as an external stopper to prevent the gastrostomy catheter 10 from falling out of the penetration portion W0 into the stomach H3.
[0041] As shown in Figure 2, the lid portion 13 has a main body portion 13a connected to the other end (external end) of the catheter body 11, a flexible strap portion 13b connected to the main body portion 13a, and a stopper 13c provided on the strap portion 13b. The main body portion 13a has a flow path 13d that communicates with the space 11f between the outer tube 11a and the inner tube 11b, an injection port 13e that communicates with the flow path 13d and into which a syringe or the like for injecting expansion fluid can be inserted, and an opening 13f that communicates with the lumen 11c of the inner tube 11b. The main body portion 13a is also provided with a check valve (not shown) that prevents the contents of the stomach H3 from flowing back out of the body through the lumen 11c of the catheter body 11.
[0042] As shown in Figure 6, by bending the strap portion 13b and inserting the stopper 13c into the opening 13f, the stopper 13c closes the opening 13f. Hereinafter, this state will be referred to as the "closed state of the lid portion 13". On the other hand, as shown in Figure 2, when the stopper 13c is not closing the opening 13f, a tube for injecting nutritional supplements, etc., can be connected to the opening 13f. Hereinafter, this state will be referred to as the "open state of the lid portion 13". When the lid portion 13 is open, if nutritional supplements, etc., are injected into the opening 13f from a tube, etc., the check valve opens, and the nutritional supplements, etc., are injected into the stomach H3 through the lumen 11c.
[0043] However, the configuration of the gastrostomy catheter is not limited to the above. For example, the gastrostomy catheter may be a so-called button-bumper type, which has an expandable and contractible bumper as an internal stopper. In a button-bumper type gastrostomy catheter, the bumper corresponds to the expander. Furthermore, the method of using the gastrostomy catheter is not limited to the above. For example, the gastrostomy catheter may be used to decompress the gastric H3.
[0044] Next, we will explain the 100-unit implantation support kit. The implantation support kit 100, as outlined in Figure 1, comprises an implantation support device 110, a loop-shaped guide wire 120, a rod 130, and a spacer 140. The parts of the implantation support kit 100 will be described below. In the following, the side of the implantation support device 110 that exits the body from the oral cavity H1 of patient H0 will be referred to as the "proximal end," and the opposite side will be referred to as the "proximal end." Furthermore, in each part of the implantation support device 110, a certain range from the tip (outermost point) of each part toward the proximal end will be referred to as the "proximal part," and a certain range from the proximal end (very proximal end) of each part toward the proximal end will be referred to as the "proximal end."
[0045] First, let me explain the indwelling support device 110. The implantation aid 110 comprises a flexible, elongated shaft 111, a base 112 provided at the tip of the shaft 111, a first end member 113 that can be attached to and detached from the base 112, a second end member 114 that can be attached to the base 112 in place of the first end member 113, and a hand-operated part 115 provided at the base end of the shaft 111.
[0046] In this embodiment, the shaft 111 is composed of a long, flexible tube. Hereinafter, the direction in which the shaft 111 extends will be referred to as the "axial direction." The shaft 111 is composed of a flexible material. Such materials are not particularly limited, but include thermoplastic resins such as polyethylene, polypropylene and other polyolefins, and soft polyvinyl chloride; various elastomers such as polyurethane elastomer, polyamide elastomer, and polyester elastomer; and crystalline plastics such as crystalline polyethylene and crystalline polypropylene. However, as long as the shaft is flexible, it is not limited to hollow tubes, etc., but may also be solid, for example.
[0047] Hereinafter, the length of each part of the implantation aid 110 along the axial direction will simply be referred to as "length". As will be explained in detail later, as shown in Figures 4(a) and (b), with the proximal end of the shaft 111 exposed outside the body, the tip of the shaft 111 is positioned near the planned site for gastrostomy in the stomach H3, via the oral cavity H1 and esophagus H2. Therefore, the length of the shaft 111 is such that, with at least the proximal end of the shaft 111 outside the body from the patient H0's oral cavity H1, the tip of the shaft 111 can reach near the planned site for gastrostomy in the stomach H3, via the oral cavity H1 and esophagus H2. The length of the shaft 111 is not particularly limited, but is preferably 60 cm to 120 cm, and more preferably 80 cm to 100 cm. By setting the length of the shaft 111 within the above range, the tip of the shaft 111 can reach the penetration W0 while the proximal end of the shaft 111 is sufficiently outside the body from the oral cavity H1.
[0048] As shown in Figure 1, the diameter (outer diameter) of the tip of the shaft 111 gradually decreases from the tip to the base. Hereinafter, this portion will also be referred to as the "first portion 111a". The diameter (outer diameter) of the portion of the shaft 111 closer to the base than the first portion 111a is smaller than the diameter of the first portion 111a. Hereinafter, the portion closer to the base than the first portion 111a will also be referred to as the "second portion 111b". In this specification, "diameter gradually decreases" does not mean that the diameter decreases strictly, but rather that it decreases to an extent that allows for manufacturing tolerances. In this embodiment, the second portion 111b is connected to the base of the first portion 111a and has a constant diameter from the tip to the base of the shaft 111. In this specification, "constant diameter" or "same diameter" does not mean that the diameters of the shafts 111 are exactly the same, but rather that the diameters are substantially the same to an extent that allows for manufacturing tolerances.
[0049] The length of the first part 111a is not particularly limited, but is preferably 1 cm to 10 cm, and more preferably 2 cm to 5 cm. The length of the second part 111b is not particularly limited, but is preferably 50 cm to 119 cm, and more preferably 70 cm to 99 cm. By setting the lengths of the first part 111a and the second part 111b within the above ranges, as shown in Figure 4(b), although details will be described later, when the first part 111a reaches the vicinity of the planned site for gastrostomy in the stomach H3, the second part 111b, which has a relatively small diameter, is positioned in the esophagus H2. Therefore, with the shaft 111 positioned in the esophagus H2, operations such as insertion and passage of the endoscope 30 into the esophagus H2 become easier.
[0050] The diameter (outer diameter) of the tip of the first part 111a is preferably 5 mm or more and 9 mm or less, and more preferably 6 mm or more and 8 mm or less. This allows the diameter of the tip of the shaft 111 to correspond to the diameter of the base 112, which will be described later. The diameter (outer diameter) of the second part 111b is preferably 3 mm or more and 6 mm or less, and more preferably 4 mm or more and 5 mm or less. This makes it easier to insert and pass the endoscope 30 into the esophagus H2 when the shaft 111 is positioned in the esophagus H2.
[0051] Incidentally, there are individual differences in the thickness of the abdominal wall W1 and the stomach wall W2. Generally, to accommodate individual differences in the thickness of the abdominal wall W1 and the stomach wall W2, the gastrostomy catheter 10 has several variations in the length of the catheter body 11. In this embodiment, the tip of the shaft 111 is provided with a scale indicating the distance from the reference position P1, extending from the reference position P1 on the tip side of the shaft 111 toward the proximal end. The scale is not particularly limited as long as, as shown in Figure 4(c), when the reference position P1 of the shaft 111 is positioned so that it is roughly flush with the surface of the abdominal wall W1, the operator can confirm the scale using the camera function of the endoscope 30 placed inside the stomach H3, and determine the gastrostomy catheter 10 with a length suitable for the patient H0's abdominal wall W1 and stomach wall W2 thickness. Examples of such a scale include marks such as lines provided at unit length intervals from the reference position P1, numerical values indicating the length from the reference position P1, or a combination of marks and numerical values.
[0052] In this embodiment, as shown in Figure 1, the tip of the shaft 111 is defined as the reference position P1, and the scale is composed of lines and numbers provided at 1 cm intervals from the reference position P1. The scale is not particularly limited, but it is preferable that it be provided within a range of 10 cm from the reference position P1. However, the interval between the scales is not particularly limited to 1 cm, and may be 5 mm or 1 mm. Furthermore, the reference position is not limited to the tip of the shaft.
[0053] The base 112 has a proximal end 112a inserted into the lumen of the shaft 111, an intermediate portion 112b connected to the tip of the proximal end 112a and protruding from the shaft 111 toward the tip, and a male screw-shaped tip portion 112c provided at the tip of the intermediate portion 112b. The proximal end 112a is fixed to the shaft 111 by adhesive or welding. The intermediate portion 112b is cylindrical. The diameter of the intermediate portion 112b is approximately the same as the diameter of the tip of the shaft 111.
[0054] As shown in Figure 1, the first tip member 113 has a base end portion 113a that can be attached to and detached from the base 112, a tapered portion 113b that is connected to the tip of the base end portion 113a and tapers from the base end side to the tip side, and a loop wire 113c provided at the tip of the tapered portion 113b.
[0055] As will be explained in more detail later, as shown in Figures 4(a) to (c), with the first tip member 113 attached to the base 112, the loop wire 113c is tied to the loop-shaped guide wire 120. This connects the indwelling aid 110 with the first tip member 113 attached to the loop-shaped guide wire 120. In this state, the first tip member 113 is pulled by the loop-shaped guide wire 120, expanding the puncture portion of the double needle 20 (described later) from the stomach wall W2 side toward the abdominal wall W1 side, and penetrating both the stomach wall W2 and the abdominal wall W1. This creates an expanded penetration portion W0.
[0056] The proximal end 113a and tapered portion 113b have greater rigidity than the shaft 111 and possess sufficient rigidity to penetrate the gastric wall W2 and abdominal wall W1 while expanding the puncture site. The loop wire 113c is flexible.
[0057] The base portion 113a is a hexagonal prism shape with its central axis extending along the axial direction. Therefore, the shape of the base portion 113a when viewed from the axial direction is hexagonal. On the surface (bottom surface) of the base portion 113a facing the base 112, a female thread 113d is formed that can be screwed onto the male threaded tip portion 112c of the base 112. The first tip member 113 is attached to the base 112 by screwing it onto it.
[0058] In this embodiment, the tapered portion 113b is approximately conical in shape. Although not shown, a hole is formed at the tip of the tapered portion 113b, extending from the tip towards the base end. The loop wire 113c is constructed by inserting both ends of a single wire into this hole and fixing both ends to the tapered portion 113b by adhesive or the like.
[0059] The apex angle of the roughly conical tapered portion 113b is preferably 8 degrees or more and 16 degrees or less, and more preferably 10 degrees or more and 14 degrees or less. By setting the apex angle within the above range, the tip of the tapered portion 113b can be made sharp. As a result, the first tip member 113 can easily expand the puncture portion from the stomach wall W2 side toward the abdominal wall W1 side, and easily penetrate both the stomach wall W2 and the abdominal wall W1.
[0060] Furthermore, as mentioned above, a hole for inserting the loop wire 113c is formed at the tip of the tapered portion 113b, so the tip of the tapered portion 113b is not perfectly pointed. However, the diameter (thickness) of the loop wire is sufficiently smaller than the diameter (thickness) of the guide wire inserted into the lumen of the dilator in the introducer modification. Therefore, the diameter of the hole for inserting the loop wire 113c formed at the tip of the tapered portion 113b is sufficiently smaller than the diameter of the lumen formed in the dilator for guide wire insertion. As a result, the tip of the tapered portion 113b can be made sharper than the tip of the dilator. This allows the first tip member 113 to easily expand the puncture site from the stomach wall W2 side towards the abdominal wall W1 side, while easily penetrating both the stomach wall W2 and the abdominal wall W1.
[0061] The diameter (outer diameter) of the tip of the tapered portion 113b is not particularly limited, but is preferably 2 mm or less, and more preferably 1 mm or less. This allows the tip of the first tip member 113 to be sharp. The diameter of the base end of the tapered portion 113b is the same as the diameter of the base 112.
[0062] The second tip member 114 can be attached to the base 112 in place of the first tip member 113, and has a storage space 114c formed therein that can accommodate the contracted expandable body 12 of the gastrostomy catheter 10 by inserting it from the tip side. As will be described in detail later, the second tip member 114 accommodates the gastrostomy catheter 10 by housing the contracted expandable body 12 in the storage space 114c, as shown in Figures 5(a) to (c). The second tip member 114 is then pushed into the stomach H3 from the abdominal wall W1 side, thereby positioning the gastrostomy catheter 10 in the penetration W0.
[0063] Specifically, as shown in Figure 1, the second tip member 114 has a base end portion 114a that is detachable from the base 112, and a housing portion 114b that is connected to the tip of the base end portion 114a and can accommodate the expanded body 12 in a contracted state. The second tip member 114 has higher rigidity than the shaft 111 and has sufficient rigidity to maintain the expanded state of the through portion W0 formed by the first tip member 113.
[0064] As shown in Figure 3, the base end portion 114a is a hexagonal prism shape with its central axis extending along the axial direction. Therefore, the shape of the base end portion 113a when viewed from the axial direction is hexagonal. On the surface (bottom surface) of the base end portion 114a facing the base 112, a female thread 114d is formed that can be screwed into the male threaded tip portion 112c of the base 112. The second tip member 114 is attached by screwing it into the base 112.
[0065] The housing section 114b is a bottomed cylindrical shape with an open tip. The internal space of the housing section 114b corresponds to the housing space 114c. In this embodiment, the housing section 114b includes a first cylindrical section 114e whose outer and inner diameters gradually increase from the proximal end to the tip, and a second cylindrical section 114f connected to the tip of the first cylindrical section 114e, with constant outer and inner diameters. The expandable body 12 of the gastrostomy catheter 10 has a shape that is slightly bulging toward the lid section 13 when contracted. Therefore, by making the housing section 114b have a shape that includes the first cylindrical section 114e and the second cylindrical section 114f, the shape of the housing space 114c can be made to correspond to the shape of the expandable body 12 of the gastrostomy catheter 10. This allows the diameter of the base end 114a of the second tip member 114 to match the diameter of the base 112 and the base end 113a of the first tip member 113, while making the housing portion 114b shaped to accommodate the gastrostomy catheter 10. However, the shape of the housing portion is not limited to the above, as long as the expanded body of the gastrostomy catheter in a contracted state can be inserted from the tip side and accommodated. For example, the shape of the housing portion may be cylindrical with an inner and outer diameter that is approximately constant.
[0066] As shown in Figure 5(b), the length of the expandable body 12 along its longitudinal direction is L1 [mm], and the length of the portion of the catheter body 11 located between the lid 13 and the expandable body 12 is L2 [mm]. The depth L3 [mm] of the housing space 114c is not particularly limited, but it is preferably L1 or greater and (L1 + L2) * 3 / 4 or less. By setting the depth L3 of the housing space 114c to be greater than or equal to the lower limit above, as will be described in detail later, the housing portion 114b can prevent the catheter body 11 from deforming due to the pushing force of the rod 130 when the rod 130 is inserted through the opening 13f of the gastrostomy catheter 10 mounted on the second tip member 114. Furthermore, by setting the depth L3 of the housing space 114c to be less than or equal to the upper limit above, the length of the second tip member 114 can be prevented from becoming excessively long. This makes it easier to separate the second tip member 114 from the gastrostomy catheter 10 positioned in the penetration portion W0. Specifically, the depth L3 of the storage space 114c is not particularly limited, but is preferably 30 mm or more and 40 mm or less, and more preferably 33 mm or more and 37 mm or less.
[0067] The length of the first cylindrical portion 114e is preferably 5 mm or more and 15 mm or less, and more preferably 9 mm or more and 11 mm or less. The length of the second cylindrical portion 114f is preferably 15 mm or more and 35 mm or less, and more preferably 22 mm or more and 28 mm or less.
[0068] The outer diameter of the base end of the first cylindrical portion 114e is the same as the diameter of the base 112. The outer diameter of the second cylindrical portion 114f is preferably 6 mm or more and 10 mm or less, and more preferably 7 mm or more and 9 mm or less. The wall thickness of the housing portion 114b is preferably 0.4 mm or more and 1.0 mm or less, and more preferably 0.6 mm or more and 0.9 mm or less.
[0069] The configuration of the base, the first end member, and the second end member is not limited to those described above. For example, a female screw may be provided at the tip of the base, and male screws may be provided at the base ends of the first and second end members. Furthermore, the first and second end members may be detachable by fitting them to and releasing the base.
[0070] The hand-operated section 115 has higher rigidity than the shaft 111. As shown in Figure 1, the hand-operated section 115 has a cylindrical gripping section and a tip section connected to the tip of the gripping section, where the diameter gradually decreases from the base end to the tip end, and to which the second portion 111b of the shaft 111 is fixed. However, the shape of the hand-operated section is not limited to the above. Also, the implantation aid does not necessarily have to be provided with a hand-operated section.
[0071] The materials that constitute the base 112, the base end 113a of the first tip member 113, the tapered portion 113b, the second tip member 114, and the hand-operated section 115 are not particularly limited, but examples include thermoplastic resins such as polycarbonate, polyamide, polysarsan, and polyarylate, and metal materials such as stainless steel.
[0072] Next, we will describe the loop-shaped guide wire 120. One end of the loop-shaped guidewire 120 is drawn out of the body from the outer casing 21 of the double needle 20, passing through the stomach H3, esophagus H2, and oral cavity H1, as shown in Figure 4(a), although this will be described in detail later. The loop wire 113c of the first tip member 113 is then attached to this end. In this way, the loop-shaped guidewire 120 is connected to the indwelling aid 110 with the first tip member 113 attached. Then, by pulling the portion of the loop-shaped guidewire 120 that is exposed outside the body from the outer casing 21, the entire loop-shaped guidewire 120 is removed from the body, and the first tip member 113 is led out of the body via the oral cavity H1, esophagus H2, and stomach H3. The loop-shaped guidewire 120 is, for example, made by folding a long wire in half and fixing the ends of the wire together. As shown in Figure 1, the loop-shaped guidewire 120 is inserted into the lumen of the sheath 121 and is drawn out of the sheath 121 when in use.
[0073] Next, let's explain rod 130. As shown in Figures 5(b) and (c), the rod 130 is inserted into the lumen 11c of the gastrostomy catheter 10 mounted on the second tip member 114 and is used to push the second tip member 114 from the abdominal wall W1 side toward the stomach wall W2 side. The rod 130 has a rod body 131 which is the part that can be inserted into the lumen 11c, and a handle portion 132 provided at one end of the rod body 131.
[0074] The rod body 131 extends in a straight line. The tip of the rod body 131 is rounded. The length L4 [mm] of the rod body 131 is longer than the sum L0 + L3, which is the total length L0 [mm] of the gastrostomy catheter 10 and the depth L3 of the housing space 114c. As a result, as will be described in detail later, the tip of the rod body 131 can be made to protrude from the lumen 11c of the gastrostomy catheter 10 and abut against the bottom surface of the housing space 114c of the second tip member 114 and then pushed away. This allows the second tip member 114 to be easily separated from the gastrostomy catheter 10 positioned in the penetration W0.
[0075] The length L4 of the rod body 131 is not particularly limited, but is preferably 80 mm to 180 mm, and more preferably 80 mm to 150 mm. The diameter of the rod body 131 is not particularly limited, but is preferably 1 mm to 3 mm, and more preferably 2 mm to 3 mm. The handle portion 132 is roughly disc-shaped. However, the shape of the handle portion is not particularly limited.
[0076] The constituent material of the rod 130 is not particularly limited, but examples include stainless steel metal materials, polycarbonate, polyamide, polysarsan, polyarylate, and other thermoplastic resins. The constituent materials of the rod body 131 and the handle portion 132 may be the same or different. Furthermore, the rod does not necessarily have to have a handle portion.
[0077] Next, I will explain spacer 140. As shown in Figure 6, the spacer 140 is attached to the outer surface of the catheter body 11 of the gastrostomy catheter 10, which is positioned in the penetration W0, and prevents the gastrostomy catheter 10 from sliding in the penetration W0 immediately after placement.
[0078] As shown in Figures 1 and 6, the spacer 140 is disc-shaped. The spacer 140 is made of an elastic material. Such materials are not particularly limited, but include polyurethane elastomers, polyamide elastomers, polyester elastomers, and other elastomers. A through-hole 141 is formed in the center of the spacer 140, into which the catheter body 11 of the gastrostomy catheter 10 can be placed. The spacer 140 also has a slit 142 that extends radially outward from the through-hole 141.
[0079] Because the spacer 140 is elastic, it deforms to widen the slit 142, allowing the catheter body 11 to be positioned in the through-hole 141 through the widened slit 142. When the deformation of the spacer 140 is released in this state, the spacer 140 returns to its original shape, and the inner circumferential surface of the slit 142 (the through-hole forming surface) comes into close contact with the outer circumferential surface of the catheter body 11. This allows the spacer 140 to be attached to the outer circumferential surface of the catheter body 11.
[0080] Next, with reference to Figures 4(a) to 6, the method of inserting the gastrostomy catheter 10 using the insertion support kit 100 will be explained. Note that in Figures 5(a) to 5(c), the second tip member 114 is shown at its end face for clarity of explanation. Insertion of the gastrostomy catheter 10 using the insertion support kit 100 is performed under observation with a gastroscopy using the following procedure.
[0081] First, the surgeon performs gastric wall fixation around the planned site for gastrostomy in the patient H0's abdomen, securing the gastric wall W2 to the abdominal wall W1 using ligature T1 or similar. The gastric wall W2 is fixed to the abdominal wall W1 at two points.
[0082] Next, the surgeon makes an incision of about 10 to 12 mm in the abdominal area where the gastrostomy is to be created. Next, the surgeon inserts a double needle 20, with an inner needle (not shown) positioned inside the lumen of the outer cannula 21, into the stomach H3 through the incision. Next, the surgeon removes the inner needle from the outer cannula 21 of the double needle 20.
[0083] Next, the surgeon inserts one end of the loop-shaped guidewire 120 into the stomach H3 through the lumen of the outer sheath 21 of the double needle 20. Next, the surgeon grasps one end of the loop-shaped guidewire 120 with the forceps of the endoscope 30, which was inserted through the oral cavity H1 and positioned inside the stomach H3. Next, the surgeon withdraws the endoscope 30 from the body through the oral cavity H1, thereby pulling one end of the loop-shaped guidewire 120 out of the body through the oral cavity H1.
[0084] Next, as shown in Figure 4(a), the surgeon attaches the loop wire 113c of the first tip member 113, which is attached to the base 112, to one end of the loop-shaped guide wire 120. This connects the implantation aid 110, to which the first tip member is attached, to the loop-shaped guide wire 120.
[0085] Next, as indicated by arrow a1 in Figure 4(a), the surgeon pulls the portion of the loop-shaped guidewire 120 that is exposed outside the body from the outer sheath 21, thereby removing the entire loop-shaped guidewire 120 from the body. As a result, the first tip member 113 of the indwelling aid 110 is exposed outside the body from the surface of the abdominal wall W1, as shown in Figure 4(b), after passing through the oral cavity H1, esophagus H2, and stomach H3. At this time, the outer sheath 21 of the double needle 20 is removed from the body together with the loop-shaped guidewire 120.
[0086] The tip of the first tip member 113 is provided with a sharp tapered portion 113b, so that the first tip member 113 easily expands the puncture portion of the double needle 20 and easily penetrates the stomach wall W2 and abdominal wall W1. This forms an expanded penetration portion W0. The first tip member 113 penetrates the stomach wall W2 and abdominal wall W1 in this order. The abdominal wall W1, which is more rigid than the stomach wall W2, is in close contact with the outside of the flexible and highly extensible stomach wall W2, so when the first tip member 113 expands the puncture portion and penetrates the stomach wall W2 and abdominal wall W1, it is possible to suppress overstretching and damage to the stomach wall W2. In other words, the burden on the stomach wall W2 can be suppressed. Furthermore, by suppressing the burden on the stomach wall W2, two points of fixation to the stomach wall are sufficient.
[0087] As shown in Figure 4(c), the operator adjusts the position of the indwelling aid 110 so that the reference position P1 of the shaft 111 is approximately flush with the surface of the abdominal wall W1. Next, the operator checks the scale on the shaft 111 again using the camera function of the endoscope 30 which has been placed inside the stomach H3, and selects a gastrostomy catheter 10 with a length suitable for the thickness of the patient H0's abdominal wall W1 and stomach wall W2. As mentioned above, in this embodiment, the diameter of the second portion 111b, which is located proximal to the first portion 111a (tip) of the shaft 111, is smaller than the diameter of the first portion 111a. Therefore, with the shaft 111 positioned in the esophagus H2, operations such as inserting or passing the endoscope 30 into the esophagus H2 become easier.
[0088] In other words, the diameter of the first portion 111a of the shaft 111 is larger than the diameter of the second portion 111b. This allows the diameter of the first portion 111a (tip portion) of the shaft 111 to correspond to the diameter of the first tip member 113, which has a certain diameter for expanding the puncture site, and the second tip member 114, which has a certain diameter for mounting the gastrostomy catheter 10.
[0089] Next, the surgeon removes the first tip member 113 from the base 112. The surface of the first tip member 113, which has passed through the body of patient H0, may have bodily fluids from patient H0 adhering to it, making it slippery. In contrast, in this embodiment, the base end 113a of the first tip member 113 is hexagonal when viewed from the axial direction. Therefore, the surgeon can easily and firmly grasp the side of the base end 113a using an instrument such as forceps, and rotate the base end 113a relative to the base 112 to easily release the screw-in of the base end 113a to the base 112.
[0090] Next, the surgeon attaches the second tip member 114 to the base 112. In this embodiment, the base end portion 114a of the second tip member 114 is also hexagonal when viewed from the axial direction of the shaft 111. Therefore, the surgeon can easily screw the base end portion 114a to the base 112 in the same manner.
[0091] Next, as shown in Figure 5(a), the surgeon inserts the contracted expanded body 12 of the gastrostomy catheter 10 into the housing space 114c of the second tip member 114 from the tip side. This places the gastrostomy catheter 10 on the second tip member 114. The gastrostomy catheter 10 placed here is one that has been selected to have a length suitable for the thickness of the patient H0's abdominal wall W1 and stomach wall W2. The lid 13 of the gastrostomy catheter 10 is left open.
[0092] Next, as shown in Figure 5(b), the surgeon pushes the rod body 131 of the rod 130 into the lumen 11c of the gastrostomy catheter 10 through the opening 13f of the gastrostomy catheter 10 mounted on the second tip member 114. As a result, the second tip member 114 is pushed in from the abdominal wall W1 side toward the stomach wall W2 side. Consequently, the catheter body 11 of the gastrostomy catheter 10 is positioned at the penetration W0 while still mounted on the second tip member 114.
[0093] From this state, the operator pushes the rod body 131 further, causing the tip of the rod body 131 to protrude from the lumen 11c of the gastrostomy catheter 10, as shown in Figure 5(c), and to strike and push away the bottom surface of the housing space 114c of the second tip member 114. As a result, the second tip member 114 separates from the gastrostomy catheter 10 and is pushed into the stomach H3.
[0094] The puncture portion of the double needle 20 is pre-expanded by the first tip member 113 to form a penetration portion W0, and the second tip member 114 is pushed into the stomach H3 while maintaining and slightly expanding the expanded state of the penetration portion W0. Therefore, the burden on the stomach wall W2 when pushing the second tip member 114 and the gastrostomy catheter 10 from the abdominal wall W1 side to the stomach wall W2 side can be reduced compared to the introducer modification.
[0095] As a result, the catheter body 11 of the gastrostomy catheter 10 is positioned at the penetration W0, the lid 13 is positioned directly above the abdominal wall W1, and the expander 12 is positioned inside the stomach H3. Next, the surgeon removes the rod 130 from the lumen 11c of the gastrostomy catheter 10.
[0096] Next, the surgeon connects a syringe to the injection port 13e of the lid 13 and injects the expansion fluid into the space 11f between the outer tube 11a and inner tube 11b of the gastrostomy catheter 10, thereby expanding the expander 12 as shown in Figure 6. Next, the surgeon uses the camera function of the endoscope 30 to check the degree of expansion of the expander 12 and the degree of bleeding around the penetration W0. The surgeon also attaches a spacer 140 to the outer surface of the catheter body 11 that is exposed to the outside of the body from the abdominal wall W1. This prevents the gastrostomy catheter 10 from sliding at the penetration W0 immediately after placement. At this time, the surgeon may place gauze between the spacer 140 and the abdominal wall W1, around the catheter body 11. Next, the surgeon removes the placement aid 110 with the second tip member 114 attached and the endoscope 30 from the oral cavity H1.
[0097] As a result, a button-type gastrostomy catheter can be placed in a single procedure, i.e., in one stage. Furthermore, since the relatively large diameter expander 12 and lid 13 do not pass through the junction between the esophagus H2 and stomach H3, the burden on the junction between the esophagus H2 and stomach H3 can be reduced.
[0098] Furthermore, the indwelling support kit does not necessarily have to include a loop-shaped guidewire, rod, and spacer, and may include other medical devices such as a double needle or gauze. If the indwelling support kit does not include a loop-shaped guidewire, a known loop-shaped guidewire used in the pull method, etc., can be used. Also, if the indwelling support kit does not include a rod, a known rod such as a gastrostomy catheter replacement rod (extender) included in a gastrostomy catheter kit can be used.
[0099] As described above, the indwelling aid 110 according to this embodiment is used when a button-shaped gastrostomy catheter 10 is placed in a penetration W0 that penetrates the stomach wall W2 and the abdominal wall W1. The gastrostomy catheter 10 comprises a catheter body 11 having a lumen 11c and an expandable and contractible expander 12 provided at one end of the catheter body 11. The indwelling aid 110 comprises a shaft 111, a base 112, a first tip member 113, and a second tip member 114. The shaft 111 is flexible and long. The base 112 is provided at the tip of the shaft 111. The first tip member 113 is detachable from the base 112 and has a tapered portion 113b that tapers from the proximal end to the tip and a loop wire 113c provided at the tip of the tapered portion 113b. The second tip member 114 can be attached to the base 112 in place of the first tip member 113, and has a storage space 114c that can accommodate the contracted expanded body 12 of the gastrostomy catheter 10 by inserting it from the tip side.
[0100] Using such a catheter placement aid 110, the following method of placing a button-type gastrostomy catheter 10 can be realized. In the same manner as the pull method, one end of the loop-shaped guidewire 120 is led out of the oral cavity H1. Next, the loop wire 113c of the first tip member 113, which is attached to the base 112, is connected to one end of the loop-shaped guidewire 120. This connects the loop-shaped guidewire 120 to the catheter placement aid 110 with the first tip member 113 attached. Next, the portion of the loop-shaped guidewire 120 that is exposed outside the body is pulled, and the entire loop-shaped guidewire 120 is removed from the body. This leads the first tip member 113 out of the body via the oral cavity H1, esophagus H2, and stomach H3.
[0101] The tip of the first tip member 113 is provided with a sharp tapered portion 113b, so that the first tip member 113 expands the puncture site and easily penetrates the stomach wall W2 and abdominal wall W1 to form a penetration portion W0. Furthermore, the first tip member 113 penetrates the stomach wall W2 and abdominal wall W1 in this order. The abdominal wall W1, which is more rigid than the stomach wall W2, is in close contact with the outside of the flexible and highly extensible stomach wall W2, so when the first tip member 113 penetrates the stomach wall W2 and abdominal wall W1, it is possible to suppress overstretching and damage to the stomach wall W2. In other words, the burden on the stomach wall W2 can be suppressed.
[0102] Next, the second tip member 114 is attached to the base 112 in place of the first tip member 113, and the contracted expanded body 12 of the gastrostomy catheter 10 is inserted into the housing space 114c of the second tip member 114 from the tip side. This mounts the gastrostomy catheter 10 on the second tip member 114. Then, the second tip member 114 is pushed together with the gastrostomy catheter 10 from the abdominal wall W1 side toward the stomach wall W2 side, thereby positioning the gastrostomy catheter 10 in the penetration portion W0.
[0103] The puncture site is first expanded with the first tip member 113 to form a penetration W0, and the second tip member 114 is pushed into the stomach H3 while maintaining the expanded state of the penetration W0. Therefore, the burden on the stomach wall W2 when pushing the second tip member 114 and the gastrostomy catheter 10 from the abdominal wall W1 to the stomach wall W2 can be reduced compared to the introducer modification. Next, the expandable body 12 of the gastrostomy catheter 10 is expanded inside the stomach H3. Then, the part of the shaft 111 that is exposed outside the body from the oral cavity H1 is pulled out, and the indwelling aid 110 with the second tip member 114 attached is removed from the body. This allows the button-type gastrostomy catheter 10 to be placed in the penetration W0 in a single procedure.
[0104] As described above, a button-shaped gastrostomy catheter 10 can be placed in a single stage using a method that places minimal burden on the gastric wall W2. Furthermore, since the button-shaped gastrostomy catheter 10 does not pass through the junction between the esophagus H2 and the stomach H3, the burden on the connection between the esophagus H2 and the stomach H3 can be reduced.
[0105] Furthermore, the tip of the shaft 111 is provided with markings along the axial direction of the shaft 111. This allows the operator to easily select a gastrostomy catheter 10 that is suitable for the thickness of the patient H0's abdominal wall W1 and gastric wall W2.
[0106] Furthermore, the diameter of the tip of the shaft 111 gradually decreases from the tip towards the proximal end, and the diameter of the portion of the shaft 111 closer to the proximal end is smaller than the diameter of the tip of the shaft 111. Therefore, when the shaft 111 is positioned in the esophagus H2, it becomes easier to insert or pass the endoscope 30 into the esophagus H2.
[0107] Furthermore, the first tip member 113 and the second tip member 114 are attached to the base 112 by screwing them into the base 112. Therefore, the surgeon can easily attach and detach the first tip member 113 and the second tip member 114 to the base 112.
[0108] Furthermore, the base end 113a of the first tip member 113 is hexagonal when viewed from the axial direction of the shaft 111. This allows the surgeon to easily and firmly grasp the side of the base end 113a of the first tip member 113 using an instrument such as forceps, and rotate the base end 113a to easily release the screw engagement of the base end 113a with the base 112.
[0109] Furthermore, the indwelling support kit 100 comprises an indwelling support device 110 and a rod 130 that can be inserted into the lumen 11c of the gastrostomy catheter 10, and whose insertable portion (rod body 131) has a length L4 that is longer than the sum L0 of the total length L0 of the gastrostomy catheter 10 and the depth L3 of the housing space 114c. Therefore, the operator can easily insert the rod 130 into the lumen 11c of the gastrostomy catheter 10 mounted on the second tip member 114 and push the second tip member 114 into the penetration W0 and the stomach H3.
[0110] Furthermore, the indwelling support kit 100 further includes a spacer 140 that is elastic and can be attached to the outer surface of the catheter body 11 of the gastrostomy catheter 10. The spacer 140 has a through hole 141 into which the catheter body can be placed, and a slit 142 extending radially outward from the through hole 141. Therefore, the spacer 140 can be easily attached to the outer surface of the catheter body 11 that is placed in the through hole W0. This makes it possible to suppress sliding of the gastrostomy catheter 10 in the through hole W0 immediately after placement.
[0111] Next, a modified example of this embodiment, a retaining aid 210, will be described. Figure 7 is a perspective view showing a modified example of the retention aid 210 according to this embodiment. The retaining aid 210 according to this modified example differs from the retaining aid 110 according to the previously described embodiment in the configuration of the first tip member 213. Hereinafter, the configurations that differ from the previously described embodiment in this modified example will be mainly described, and similar configurations will be denoted by the same reference numerals, and their descriptions will be omitted as appropriate.
[0112] The first tip member 213 has a base end portion 213a that is detachable from the base 112, and a tapered portion 213b that is connected to the tip of the base end portion 213a and tapers from the base end side to the tip side. In this embodiment, the base end portion 213a is cylindrical. The tapered portion 213b has a hole 213e that extends radially and into which the rod body 131 of the rod 130 can be inserted. In this embodiment, the hole 213e penetrates the first tip member 213 radially. However, the hole formed in the first tip member does not have to be a through hole.
[0113] The operator inserts the rod 130 into the hole 213e and rotates it around the axis of the shaft 111 as shown by arrow a2 in Figure 7. This allows the screw-on attachment of the first tip member 213 to the base 112 to be easily released.
[0114] Next, a modified example of the embodiment, the implantation support kit 300, will be described. Figure 8 is a plan view showing a modified example of the implantation support kit 300. Figure 9 is a schematic diagram showing a method of placing a gastrostomy catheter 10 into a penetration W0 that penetrates the gastric wall W2 and abdominal wall W1 using the rod 330 and annular member 350 provided in the indwelling support kit 300 of Figure 8. Figure 10 is a schematic diagram showing a method of placing a gastrostomy catheter 10 into a penetration W0 that penetrates the gastric wall W2 and abdominal wall W1 using the rod 330 and annular member 350 provided in the indwelling support kit 300 of Figure 8. The implantation support kit 300 according to this modified example differs from the implantation support kit 100 according to the previously described embodiment in that a male screw 331a is formed on the rod 330 and it further comprises an annular member 350 that screws onto the male screw 331a. Hereinafter, the configurations that differ in this modified example from the previously described embodiment will be mainly described, and similar configurations will be denoted by the same reference numerals, and their descriptions will be omitted as appropriate.
[0115] The rod body 331 of the rod 330 has a male thread 331a formed on it. As shown in Figure 9(a), the male thread 331a is provided on the outer circumferential surface of at least the portion of the rod body 331 that is exposed from the gastrostomy catheter 10 when the rod body 331 is inserted into the lumen 11c of the gastrostomy catheter 10. The male thread 331a may also be provided on the outer circumferential surface of the portion of the rod body 331 that is inserted into the gastrostomy catheter 10.
[0116] The annular member 350 is not particularly limited, but is composed of, for example, a nut. As shown in Figure 8, a female thread 351 that can be screwed onto the male thread 331a is formed on the inner circumferential surface of the annular member 350. The outer diameter of the annular member 350 is larger than the diameter of the opening 13f of the gastrostomy catheter 10.
[0117] As shown in Figure 9(a), the distance from the tip of the rod body 331 to the lower end of the male thread 331a is less than or equal to the total length L0 of the gastrostomy catheter 10. This allows the annular member 350, which is screwed onto the male thread 331a, to be positioned so as to contact the upper surface of the gastrostomy catheter 10 when the rod body 331 is inserted into the lumen 11c of the gastrostomy catheter 10, as will be described in detail later.
[0118] Furthermore, as shown in Figure 9(b), it is preferable that the longitudinal length L5 [mm] of the male screw 331a is greater than or equal to the sum of the depth L3 [mm] of the housing space 114c of the second tip member 114 and the length L6 [mm] of the annular member 350 along the longitudinal direction of the rod 330, i.e., L5 ≥ L3 + L6. This allows the second tip member 114 to be easily separated from the gastrostomy catheter 10 when the rod 330 is lowered relative to the gastrostomy catheter 10 positioned in the penetration W0, as will be described in detail later.
[0119] Next, with reference to Figures 9(a), (b) and 10, a method for placing the gastrostomy catheter 10 using the placement assistance kit 300 will be described. In Figures 9(a), (b) and 10, the second tip member 114 is shown at its end face for clarity of explanation. Furthermore, the procedure from fixing the catheter to the stomach wall to inserting the contracted expanded body 12 of the gastrostomy catheter 10 into the housing space 114c of the second tip member 114 from the tip side is the same as in the previously described embodiment, so the explanation will be omitted.
[0120] As shown in Figure 9(a), the gastrostomy catheter 10 is mounted on the second tip member 114, with the second tip member 114 attached to the base 112 of the indwelling aid 110 and the second tip member 114 exposed outside the body. As with the previously described embodiment, the operator keeps the lid 13 of the gastrostomy catheter 10 open. Also, as shown by the dashed line in Figure 9(a), the annular member 350 is positioned on the upper end side of the male thread 331a of the rod body 331.
[0121] Next, the surgeon pushes the rod body 331 into the lumen 11c of the gastrostomy catheter 10 mounted on the second tip member 114 through the opening 13f of the gastrostomy catheter 10 until the tip of the rod body 331 touches the bottom surface of the housing space 114c of the second tip member 114. Next, the surgeon rotates the annular member 350 relative to the male screw 331a to lower it. As a result, the annular member 350 comes into contact with the lid 13 of the gastrostomy catheter 10, as shown by the solid line in Figure 9(a).
[0122] Next, the surgeon pushes the rod 330 toward the stomach H3. Because the rod body 331 is inserted into the lumen 11c, the rod body 331 prevents the gastrostomy catheter 10 from bending, and because the annular member 350 is in contact with the lid 13, the force with which the surgeon pushes the rod 330 is efficiently transmitted to the bottom surface of the housing space 114c for the gastrostomy catheter 10 and the second tip member 114. As a result, as shown in Figure 9(b), the gastrostomy catheter 10 mounted on the second tip member 114 can be quickly positioned in the penetration W0.
[0123] Next, while maintaining the annular member 350 in contact with the gastrostomy catheter 10, the surgeon rotates the annular member 350 and the rod 330 relative to each other, causing the rod 330 to descend. As a result, as shown in Figure 10, the annular member 350 is positioned at the upper end of the male screw 331a, and the tip of the rod body 331 protrudes from the lumen 11c of the gastrostomy catheter 10, hitting and pushing away the bottom surface of the housing space 114c of the second tip member 114. This separates the second tip member 114 from the gastrostomy catheter 10 and pushes it into the stomach H3.
[0124] The subsequent procedures are the same as those described in the previously mentioned embodiment, so their explanation will be omitted. Note that, after the gastrostomy catheter 10 is positioned in the penetration W0 as shown in Figure 9(b), the surgeon may raise the annular member 350 instead of rotating the annular member 350 and the rod 330 relative to each other to lower the rod 330. The surgeon may then push the rod 330 in until the annular member 350 contacts the gastrostomy catheter 10 again. In this method as well, the tip of the rod body 331 can protrude from the lumen 11c of the gastrostomy catheter 10, abut against the bottom surface of the housing space 114c of the second tip member 114, and be pushed away.
[0125] As described above, in the indwelling support kit 300 according to this embodiment, when the rod 330 is inserted into the lumen 11c of the gastrostomy catheter 10 housed in the second tip member 114, a male thread 331a is formed on the outer circumferential surface of at least the portion of the rod 330 that is exposed from the gastrostomy catheter 10. The indwelling support kit 300 further comprises an annular member 350 having a female thread 351 formed on its inner circumferential surface that screws into the male thread 331a.
[0126] Therefore, by inserting the rod 330, with the annular member 350 screwed onto it, into the gastrostomy catheter 10 mounted on the second tip member 114, the annular member 350 can be brought into contact with the gastrostomy catheter 10. This prevents the gastrostomy catheter 10 from bending due to the portion of the rod 330 inserted into the gastrostomy catheter 10, while efficiently transmitting the force applied by the operator pushing the rod 330 to the gastrostomy catheter 10 and the second tip member 114 via the annular member 350. As a result, the gastrostomy catheter 10 mounted on the second tip member 114 can be quickly positioned into the penetration section W0. Furthermore, after positioning the gastrostomy catheter 10 in the penetration portion W0, the annular member 350 and the rod 330 can be rotated relative to each other to bring the tip of the rod 330 into contact with the bottom surface of the second tip member 114 and then push it away.
[0127] Although embodiments and modified examples of the implantation aid and implantation aid kit of the present invention have been described above, the implantation aid and implantation aid kit according to the present invention are not limited thereto. Furthermore, each part of the implantation aid and implantation aid kit can be replaced with any structure that can perform a similar function. In addition, any structure may be added. [Explanation of symbols]
[0128] 10…Gastrostomy catheter 11…Catheter body 11a...Outer tube 11b…Inner pipe 11c...lumen 11d...One end 11e...One end 11f…Space 12...Extended form 12a...One end 12b...Other end 13...Lid part 13a...Main body 13b...Strap part 13c... stopper 13…flow channel 13e... Injection port 13f…Aperture 20… Introducer 21…Outer cylinder 30…Endoscopy 100, 300... Indwelling support kit 110, 210... Indwelling aids 111... Shaft 111a...first part 111b…Second part 112... Pedestal 112a...Proximal end 112b…middle part 112c...Tip 113, 213... First tip member 113a, 213a...base end 113b, 213b... tapered section 113c... Loop wire 113d... Female thread 114...Second tip member 114a...Proximal end 114b... Containment area 114c... Containment space 114d... Female thread 114e...First cylindrical part 114f...Second cylindrical part 115...Handheld control unit 120... Loop-shaped guide wire 121...Sheath 130, 330...bar 131, 331... Rod body 132...Handle section 140... Spacer 141…Through hole 142... Slit 213e…hole 331a... Male screw 350... Annular member 351...Female thread H0…patient H1…mouth H2…Esophagus H3…stomach L0…Total length L1...Length L2...Length L3... Depth L4...Length L5...Length L6...Length P1…Reference position T1... Ligature thread W0...Penetration part W1…Abdominal wall W2…Stomach wall a1…Arrow a2…Arrow
Claims
1. A placement aid used when placing a button-shaped gastrostomy catheter, which comprises a catheter body with a formed lumen and an expandable and contractible expander provided at one end of the catheter body, into a penetration site that penetrates the stomach wall and abdominal wall, It has a flexible, long shaft, A base provided at the tip of the aforementioned shaft, A first tip member that is detachable from the base and has a tapered portion that narrows from the base end to the tip end and a loop wire provided at the tip of the tapered portion, A second tip member is provided, which can be attached to the base in place of the first tip member, and which has a storage space formed therein that allows the expanded body of the gastrostomy catheter in a contracted state to be inserted from the tip side and accommodated. An indwelling aid equipped with the necessary features.
2. The retaining aid according to claim 1, wherein the tip of the shaft is provided with a scale along the axial direction of the shaft.
3. The diameter of the tip of the shaft gradually decreases from the tip side towards the base end side. The implantation aid according to claim 1 or 2, wherein the diameter of the portion of the shaft closer to the base end than the tip end is smaller than the diameter of the tip end of the shaft.
4. The first tip member and the second tip member are attached to the base by screwing them to the base, as described in claim 1 or 2.
5. The retaining aid according to claim 4, wherein the base end of the first tip member is hexagonal when viewed from the axial direction of the shaft.
6. The implantation aid described in claim 1, A rod that can be inserted into the lumen of the gastrostomy catheter, the length of the portion that can be inserted into the lumen being longer than the sum of the total length of the gastrostomy catheter and the depth of the containment space, An indwelling support kit equipped with these features.
7. The gastrostomy catheter further comprises a disc-shaped spacer that is elastic and can be attached to the outer surface of the catheter body of the gastrostomy catheter, The catheter placement aid kit according to claim 6, wherein the spacer has a through hole into which the catheter body can be placed and a slit extending radially outward from the through hole.
8. With the rod inserted into the lumen of the gastrostomy catheter housed in the second tip member, a male thread is formed on the outer surface of at least the portion of the rod that is exposed from the gastrostomy catheter. The implantation support kit according to claim 6 or claim 7, further comprising an annular member having a female thread formed on its inner circumferential surface for screwing into the male thread.