Gastrostomy catheter and gastrostomy kit

Abstract

To provide a gastrostomy catheter and a gastrostomy kit capable of reducing a burden of a patient.SOLUTION: A gastrostomy catheter 100 includes: a tubular pipe part 113 inserted to a fistula; and a bumper part 112 configured to be deformable in a state capable of passing through the fistula and provided in a distal end side of the pipe part 113. The bumper part 112 has: a distal end pressure reception part 112a arranged so as to be spaced in a distal end side from the pipe part 113 to receive a pressing force when being deformed; a projection part 112b connecting the pipe part 113 and the distal end pressure reception part 112a and projecting in a radially outside of the pipe part 113; and a deformation suppression member 112d being another member that engages with the distal end pressure reception part 112a.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to a gastrostomy catheter and a gastrostomy kit used for a gastrostomy in which nutrients are directly injected into the stomach via a catheter that penetrates the abdominal wall and the stomach wall. [Background technology]

[0002] Conventionally, patients who have difficulty taking food orally have been treated with a gastrostomy, which allows nutrients to be directly injected into the stomach. This gastrostomy is a nutritional supplementation method in which a gastrostomy catheter is inserted and left in place through a fistula formed in the abdominal wall and stomach wall, and nutrients are supplied to the stomach through this gastrostomy catheter.

[0003] A gastrostomy catheter is left in the patient for, for example, several months. Therefore, the distal end of the gastrostomy catheter, i.e., the portion placed inside the stomach, is provided with a bumper portion that extends radially outward from the tubular portion inserted into the fistula to prevent it from falling out while in place.

[0004] For this reason, when inserting or removing a gastrostomy catheter, it is necessary to deform this bumper and reduce the protrusion before passing the catheter through the fistula. Therefore, gastrostomy catheters are generally provided as gastrostomy kits together with a dedicated obturator (rod-shaped tool) and stopper (locking member) for deforming the bumper during insertion and removal (see, for example, Patent Document 1). [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Japanese Patent Application Laid-Open No. 2014-68654 Summary of the Invention [Problem to be solved by the invention]

[0006] However, conventional gastrostomy catheters and gastrostomy kits have not been able to reduce the burden on patients, and there has been a demand for something that can reduce the burden on patients.

[0007] In view of the above circumstances, the present invention aims to provide a gastrostomy catheter and a gastrostomy kit that can reduce the burden on the patient. [Means for solving the problem]

[0008] The gastrostomy catheter of the present invention has a tubular tube section that is inserted into a fistula, and a bumper section that is provided at the distal end of the tube section and is deformable so that it can pass through the fistula, and is characterized in that the bumper section has a distal pressure-receiving section that is disposed distally from the tube section and receives a pressing force when the bumper section is deformed, a protruding section that connects the tube section and the distal pressure-receiving section and protrudes radially outward from the tube section, and a deformation-suppressing member that is a separate member that engages with the distal pressure-receiving section.

[0009] The gastrostomy kit of the present invention is characterized by comprising the gastrostomy catheter of the present invention, an obturator that applies a pressing force to the tip pressure-receiving portion when the bumper portion is deformed, and a stopper that applies a tensile force opposing the pressing force to the base end side of the gastrostomy catheter when the bumper portion is deformed.

[0010] The bumper is deformed by pressing the tip pressure-receiving portion with a thin rod-shaped member and stretching the bumper in the axial direction, but the gastrostomy catheter and gastrostomy kit of the present invention make it possible to suppress local deformation of the tip pressure-receiving portion due to the local pressing force of the thin rod-shaped member, thereby increasing the degree of freedom in designing the bumper. This makes it possible to realize a bumper that can be deformed into a shape that makes it easier than ever to insert into and remove from the fistula, thereby reducing the burden on the patient when inserting and removing the gastrostomy catheter.

[0011] In the gastrostomy catheter of the present invention, it is preferable that at least a portion of the deformation suppression member is embedded in the tip pressure-receiving portion, or at least a portion is embedded in the tip pressure-receiving portion and the protruding portion.

[0012] This allows the deformation suppression member to be more reliably engaged with the tip pressure receiving portion, thereby further enhancing the deformation suppression effect.

[0013] In the gastrostomy catheter of the present invention, the deformation suppression member is preferably configured in a flat plate shape.

[0014] This makes it possible to achieve both the deformation suppression effect of the deformation suppression member and the compactness of the bumper portion, thereby preventing the occurrence of problems such as ulcers caused by the bumper portion coming into contact with the stomach wall on the opposite side of the fistula during placement.

[0015] In the gastrostomy catheter of the present invention, the deformation suppression member preferably has a plurality of holes.

[0016] This makes it possible to ensure sufficient engagement force with the tip pressure-receiving portion through the hole, thereby increasing the freedom in the shape of the deformation suppression member and enabling a higher level of both the deformation suppression effect of the deformation suppression member and the compactness of the bumper portion.

[0017] In the gastrostomy catheter of the present invention, it is preferable that the protruding portion, at least in a portion near the tip, has a pentagonal cross section perpendicular to the longitudinal direction, with the central portion of the inner surface in the width direction raised to form a mountain shape.

[0018] This prevents accumulation of nutrients on the protruding portion, and also makes it possible to deform the outer surface of the protruding portion when the bumper is stretched into a shape that conforms to the circumference of a circle centered on the axis of the tubular portion, making it easier to insert and remove the device from the fistula.

[0019] Furthermore, the gastrostomy catheter of the present invention preferably has a connector section provided on the base end side of the tubular section to which a nutrient supply tube is connected, and the connector section also preferably serves to connect a member that applies a tensile force that counteracts the pressing force received by the tip pressure-receiving section when the bumper section is deformed.

[0020] Conventionally, when removing a gastrostomy catheter from a patient, a hook-type member (stopper) that applies a tensile force was inserted between the connector part and the patient's skin and pulled, thereby deforming the bumper part. However, with this new system, it is no longer necessary to insert a member that applies a tensile force between the connector part and the patient's skin, thereby reducing the burden on the patient.

[0021] Furthermore, in the gastrostomy catheter of the present invention, it is preferable that the connector portion has a cylindrical tubular portion and an engaged portion that is provided on the outer or inner surface of the tubular portion and that engages with an engaging portion of a connection partner, and the engaged portion has: a retaining portion that is located closer to the connection partner than at least a portion of the engaging portion and thereby holds the connection partner at a predetermined position in the axial direction of the tubular portion; a guide portion that is provided on one circumferential side of the tubular portion relative to the retaining portion and is inclined so that the surface opposite to the connection partner is gradually positioned closer to the connection partner as it moves away from the retaining portion in the circumferential direction of the tubular portion; and a restricting portion that is provided on the other circumferential side of the tubular portion relative to the retaining portion and protrudes further from the retaining portion on the side opposite to the connection partner.

[0022] According to this, simply by rotating the connecting partner around the axis of the tubular part, the engaging portion of the connecting partner can be guided to the holding part by the guiding part. Furthermore, when the engaging portion of the connecting partner reaches the holding part, it abuts against the restricting part, restricting further rotation of the connecting partner and holding the connecting partner in a predetermined position in the axial direction. In other words, it is possible to connect a supply tube or the like to the connector part without pushing it toward the patient, thereby reducing the burden on the patient.

[0023] Furthermore, the gastrostomy catheter of the present invention preferably has a flange portion that protrudes radially outward from the tubular portion on the base end side of the tubular portion, the flange portion being configured with a shape whose longitudinal direction is a specific radial direction of the tubular portion, and the connector portion being configured such that, when the connection partner is the supply tube, the supply tube extends in the longitudinal direction of the flange portion when the supply tube is held in the predetermined position by the holding portion.

[0024] Generally, the supply tube is connected to the gastrostomy catheter so that it extends radially from the tubular portion. In this way, if force is applied to the supply tube extending from the gastrostomy catheter, causing the gastrostomy catheter to tilt toward the fistula, this tilt can be effectively suppressed by the flange portion. This reduces the risk of inflammation and excessive granulation tissue in and around the fistula caused by pressure from the gastrostomy catheter, and reduces the burden on the patient.

[0025] Furthermore, the gastrostomy catheter of the present invention preferably includes a check valve that closes the tubular portion, and the check valve is configured to open the tubular portion by being pressed by the connecting partner and elastically deforming, and the engaged portion preferably has a protrusion that protrudes further from the holding portion on the holding portion side of the guide portion toward the opposite side from the connecting partner.

[0026] This allows the engaging portion of the connecting partner to overcome the protrusion against the restoring force of the elastic deformation of the check valve when it moves from the guide portion to the holding portion, thereby informing the user by a clicking sensation that the engaging portion of the connecting partner has reached the holding portion. Furthermore, by using the elastic deformation of the relatively soft check valve portion rather than the elastic deformation of the relatively hard connector portion to generate the clicking sensation, the increase in operating force required to generate the clicking sensation can be reduced, preventing excessive force from being applied to the fistula during the connection operation. In other words, a reliable connection can be achieved by a clicking sensation without increasing the burden on the patient. [Effects of the Invention]

[0027] The gastrostomy catheter and gastrostomy kit of the present invention can provide the excellent effect of reducing the burden on the patient. [Brief explanation of the drawings]

[0028] [Figure 1] FIG. 1 is a front view showing the configuration of a gastrostomy kit according to a first embodiment of the present invention. [Figure 2] 1A is a plan view of a gastrostomy catheter, B is a front view of a gastrostomy catheter, and C is a bottom view of a gastrostomy catheter. [Figure 3] 2A is a left side view of the gastrostomy catheter, and FIG. 2B is a cross-sectional view taken along line AA in FIG. 2A. [Figure 4] 3A, and FIG. 3B is a diagram showing the change in the cross-sectional shape when the protruding portion is stretched. [Figure 5] 1A is a plan view of a deformation suppressing member, B is a front view of the deformation suppressing member, and C is a plan view showing another configuration example of the deformation suppressing member. [Figure 6] 1A is a plan view of the connector portion; FIG. 1B is a front view of the connector portion; FIG. 1C is a bottom view of the connector portion; FIG. 1D is a left side view of the connector portion; and FIG. 1E is a front view showing another configuration example of the connector portion. [Figure 7] 1A and 1B are diagrams showing a method for connecting a gastrostomy catheter and a stopper. [Figure 8] 10A to 10C are diagrams illustrating a method for deforming the bumper portion. [Figure 9] 10A to 10C are diagrams illustrating a method for deforming the bumper portion. [Figure 10] FIG. 1 is a schematic diagram showing a gastrostomy catheter indwelling in a patient. [Figure 11] FIG. 10 is a front view showing the configuration of a gastrostomy kit according to a second embodiment of the present invention. [Figure 12] 1A is a plan view of a gastrostomy catheter, B is a front view of a gastrostomy catheter, and C is a bottom view of a gastrostomy catheter. [Figure 13]12A is a left side view of the gastrostomy catheter, and FIG. 12B is a cross-sectional view taken along line CC in FIG. 12A. [Figure 14] 14A is a plan view of the connector portion, B is a front view of the connector portion, C is a bottom view of the connector portion, D is a left side view of the connector portion, and E is a cross-sectional view taken along line DD in FIG. 14A. [Figure 15] 1A is a plan view of the stopper, and FIG. 1B is a left side view of the stopper. [Figure 16] 1A and 1B are diagrams showing a method for connecting a gastrostomy catheter and a stopper. [Figure 17] 10A and 10B are diagrams showing a method of connecting the obturator and the stopper when deforming the bumper portion. [Figure 18] 10A and 10B are diagrams showing an example in which the locking pieces of the obturator are configured to be elastically deformed radially outward of the thin tube portion. [Figure 19] FIG. 10 shows the state in which a supply tube is connected to a gastrostomy catheter. [Figure 20] 1A is a front view of the stopper, B is a right side view of the stopper, and C is a view showing the stopper in use when deforming the bumper portion. DETAILED DESCRIPTION OF THE INVENTION

[0029] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings.

[0030] Fig. 1 is a front view showing the configuration of a gastrostomy kit 1 according to a first embodiment of the present invention. As shown in Fig. 1, the gastrostomy kit 1 includes a gastrostomy catheter 100 to be placed in a patient, an obturator 200 for deforming the gastrostomy catheter 100 during insertion and removal, a stopper 300 for connecting the gastrostomy catheter 100 and the obturator 200 to maintain the deformed state of the gastrostomy catheter 100, and a supply tube 400 that is connected to the gastrostomy catheter 100 placed in the patient and supplies nutrients.

[0031] Gastrostomy catheter 100 is inserted into fistula 30 (see Figure 10) that has been formed in advance in the patient's abdominal wall 10 and stomach wall 20, and allows for direct injection of nutrients into the stomach by connecting the inside of the stomach with the outside of the body. Gastrostomy catheter 100 is composed of a main body 110 made of a flexible material, a connector 120 provided on the base end side of main body 110 (the side that will be placed outside the body when indwelling, the upper side in the figure), and a check valve 130 provided on the inside of connector 120.

[0032] The main body 110 has a supply passage 111 through which the nutritional agent passes, and a bumper 112 that functions as a retainer to prevent the catheter from falling out of the patient is provided on the tip side (the side that is placed inside the stomach when indwelling, the lower side in the figure). Details of the gastrostomy catheter 100 will be described later.

[0033] The obturator 200 is inserted into the supply passage 111 of the gastrostomy catheter 100 and is used to press and stretch the bumper portion 112 toward the tip side. In other words, the obturator 200 applies a pressing force to the gastrostomy catheter 100, thereby deforming the gastrostomy catheter 100 so that it can be easily inserted into and removed from the fistula 30. The obturator 200 is composed of a long, slender, tubular thin tube portion 210, a pressing portion 220 connected to the tip side (patient side, lower side in the figure) of the thin tube portion 210, and a gripping portion 230 connected to the base end side (user side, upper side in the figure) of the thin tube portion 210.

[0034] The thin tube portion 210 is a portion that transmits the force for deforming the bumper portion 112 from the grip portion 230 to the pressing portion 220. The thin tube portion 210 is made of an appropriate metal (for example, stainless steel, etc.) to ensure strength and rigidity despite its small diameter. The thin tube portion 210 is also formed in a hollow tubular shape so that a guide wire can be inserted therein.

[0035] The pressing portion 220 is a portion for widening the contact surface with the bumper portion 112 and for applying stable pressure. The pressing portion 220 is made of a suitable relatively hard resin (for example, ABS resin, etc.), and is configured in a stepped cylindrical shape into which the thin tube portion 210 is inserted and through which a guide wire from the thin tube portion 210 can be inserted. The portion of the pressing portion 220 with a smaller outer diameter on the tip side serves as a positioning portion 221 for positioning with respect to the bumper portion 112.

[0036] Grip portion 230 is a portion that is gripped by the user and receives the pressing force of the user when deforming bumper portion 112. Grip portion 230 is made of a suitable relatively hard resin (for example, ABS resin, etc.), and is provided at the base end side of grip portion 230 with force-receiving portion 231 in the shape of a rectangular flat plate that is curved so that the tip side is convex.

[0037] Further, a cylindrical accommodating portion 232 capable of accommodating the insertion portion 312 on the base end side of the stopper 300 is provided on the tip side of the gripping portion 230, and this accommodating portion 232 is provided with an L-shaped locking groove 233 that locks with the locking protrusion 313 of the stopper 300. Specifically, the locking groove 233 is composed of an introduction portion 233a extending axially from the tip of the accommodating portion 232 toward the base end side, and a locking portion 233b extending circumferentially from the inner end of the introduction portion 233a.

[0038] The gripping portion 230 is also provided with a communication groove 234 that communicates with the inside of the thin tube portion 210, and a guide wire can be inserted into the thin tube portion 210 through this communication groove 234. In this embodiment, the force receiving portion 231 is also provided with a slit 231a through which the guide wire can pass, thereby facilitating the handling of the guide wire.

[0039] The stopper 300 is connected to the base end side of the gastrostomy catheter 100, and is pulled toward the base end by the user when deforming the bumper portion 112, thereby applying a tensile force to the gastrostomy catheter 100 that opposes the pressing force of the obturator 200. After being pulled toward the base end by the user, the stopper 300 is engaged with the grip portion 230 of the obturator 200, thereby maintaining the deformed state of the bumper portion 112.

[0040] The stopper 300 is made of a suitable relatively hard resin (e.g., ABS resin, etc.) and is composed of a stepped cylindrical body 310, two engagement portions 320 provided at the tip side of the body 310, and a force receiving portion 330 provided at the base end side of the body 310.

[0041] The body portion 310 is configured as a stepped cylinder of a size that allows the thin tube portion 210 and the pressing portion 220 of the obturator 200 to be inserted therein. In other words, the body portion 310 has an insertion hole 310a through which the thin tube portion 210 and the pressing portion 220 can be inserted, and this insertion hole 310a is configured to communicate with the supply passage 111 when connected to the gastrostomy catheter 100.

[0042] The portion of the body 310 that is distal to the engaging portion 320 constitutes a valve-opening portion 311 that is inserted into the check valve portion 130 when connected to the gastrostomy catheter 100 and pushes open the valve body 131. This valve-opening portion 311 is configured to have a smaller outer diameter than the middle portion of the body 310 (the portion between the engaging portion 320 and the force-receiving portion 330). Furthermore, in order to make it easier to push open the valve body 131 of the check valve portion 130, most of the valve-opening portion 311, except for a portion on the base end side, is configured to have a tapered shape in which the outer diameter gradually decreases toward the distal end, and the corners of the distal end are appropriately rounded.

[0043] The portion of the trunk 310 closer to the base end than the force receiving portion 330 constitutes an insertion portion 312 that is inserted into the accommodation portion 232 when connected to the gripping portion 230 of the obturator 200. The insertion portion 312 is configured to have a smaller outer diameter than the intermediate portion of the trunk 310, and is provided with a large chamfer at the corner of the tip to facilitate insertion into the accommodation portion 232. A locking protrusion 313 that enters and locks into a locking groove 233 of the obturator 200 is provided on the outer peripheral surface on the tip side of the insertion portion 312.

[0044] The two engaging portions 320 are portions that engage with the connector portion 120 of the gastrostomy catheter 100, thereby locking the connection with the gastrostomy catheter 100. The two engaging portions 320 extend radially outward from the body portion 310 in opposite directions, then extend toward the tip, and finally form a J-shape such that the engaging end 321 at the tip protrudes slightly radially inward.

[0045] The force receiving portion 330 is configured as a thin, elongated rectangular flat plate that is curved so that the base end side is convex. The force receiving portion 330 is provided so that the body portion 310 penetrates the middle portion in the longitudinal direction, and extends from the body portion 310 in the same direction as the two engaging portions 320. In this embodiment, by aligning the extension direction of the force receiving portion 330 with the two engaging portions 320, the operability of the stopper 300 is improved and the bulkiness of the package containing the stopper 300 is reduced.

[0046] The supply tube 400 connects a nutritional bag or syringe containing a nutrient to the gastrostomy catheter 100, and is used to supply the nutrient to the gastrostomy catheter 100. The supply tube 400 is composed of a flexible tube section 410 made of an appropriate flexible resin (for example, PVC resin), a distal connector section 420 provided at one end of the flexible tube section 410, and a proximal connector section (not shown) provided at the other end of the flexible tube section 410.

[0047] The distal connector section 420 connects the supply tube 400 to the gastrostomy catheter 100. The distal connector section 420 is made of an appropriate resin (for example, PVC resin, etc.) and has a valve opening section 421 and two engagement sections 422 that are configured similarly to the stopper 300. That is, in this embodiment, the connector section 120 of the gastrostomy catheter 100 is used for both connection to the stopper 300 and connection to the supply tube 400.

[0048] The valve opening part 421 has a circumferentially continuous rib 421a provided on the outer peripheral surface of the base end side of the tapered portion, and this rib 421a is in close contact with the inner peripheral surface of the check valve part 130, thereby ensuring the sealing of the passage for the nutrient solution. In addition, the two engaging parts 422 are each configured in an L shape to match the tip side connector part 420, extending towards the tip side and then with the engaging end 422a at the tip part protruding slightly towards the valve opening part 421 side.

[0049] Note that, since supply tube 400 of the present embodiment is a general continuous administration type, distal connector portion 420 is configured so that the protruding direction of valve-opening portion 421 is approximately perpendicular to the extending direction of flexible tube portion 410, but it goes without saying that supply tube 400 may also be a rapid administration type in which valve-opening portion 421 is arranged coaxially with flexible tube portion 410. Furthermore, the configuration of the proximal connector portion is not particularly limited, and an existing connector that can be connected to a nutrition bag, a syringe, or the like can be used.

[0050] Next, the gastrostomy catheter 100 will be described in detail.

[0051] Fig. 2A is a plan view (viewed from the base end side) of the gastrostomy catheter 100, Fig. 2B is a front view of the gastrostomy catheter 100, and Fig. 2C is a bottom view (viewed from the tip side) of the gastrostomy catheter 100. Fig. 3A is a left side view of the gastrostomy catheter 100, and Fig. 3B is a cross-sectional view taken along line AA in Fig. 2A. As described above, the gastrostomy catheter 100 is composed of a main body portion 110, a connector portion 120, and a check valve portion 130.

[0052] The main body 110 is made of a suitable relatively soft resin (for example, silicone resin), and is composed of a cylindrical tube 113, a bumper 112 provided at the tip end of the tube 113, a flange 114 provided at the base end of the tube 113, and a cap 115 connected to the flange 114. The tube 113, bumper 112, and flange 114 are provided with a supply passage 111 for supplying a nutrient into the stomach.

[0053] When placed, most of tubular portion 113 is disposed within fistula 30. The outer diameter of tubular portion 113 is approximately constant in the middle portion, but gradually expands toward bumper portion 112 and flange portion 114, thereby smoothly connecting to both.

[0054] The bumper section 112 prevents the gastrostomy catheter 100 from falling out of the body by projecting radially outward beyond the tubular section 113. The bumper section 112 is composed of a tip pressure-receiving section 112a that is spaced apart from the tip side of the tubular section 113, and four projecting sections 112b that connect the tip pressure-receiving section 112a and the tubular section 113 and project radially outward from the tubular section 113.

[0055] The distal pressure receiving portion 112a is a portion that is pressed by the pressing portion 220 of the obturator 200 when the bumper portion 112 is deformed. The distal pressure receiving portion 112a has a dome-shaped outer shape on the distal end side and a through-hole 112c penetrating in the axial direction provided in the center. This through-hole 112c is for inserting a guidewire. In this embodiment, the inner diameter of a portion of the through-hole 112c on the proximal end side gradually increases toward the proximal end side, thereby facilitating insertion of the guidewire. Furthermore, the portion of the through-hole 112c whose inner diameter gradually increases toward the proximal end side forms a positioning recess 112c1 into which the positioning portion 221 of the pressing portion 220 fits and is positioned, as shown by the two-dot chain line in FIG. 3B .

[0056] The protruding portion 112b is formed by bending a substantially strip-shaped member in the thickness direction, so as to have a U-shape that extends radially outward from the pipe portion 113 and then radially inward to connect to the tip pressure receiving portion 112a. In this embodiment, four protruding portions 112b are arranged at intervals of approximately 90 degrees in the circumferential direction, and are provided so as to present a cross shape in bottom view (viewed from the tip side).

[0057] Fig. 4A is a cross-sectional view taken along line BB in Fig. 3A. The cross-sectional shape of protruding portion 112b perpendicular to the longitudinal direction is a pentagon in which the central portion in the width direction of inner surface 112b1 is raised to form a mountain shape, except for a portion on the base end side (the side facing tubular portion 113). More specifically, protruding portion 112b is configured such that the height H of the mountain shape gradually increases from the rectangular shape on the base end side toward the tip end side, and the width W gradually decreases toward the tip end in the longitudinal intermediate portion, making the width W on the tip end side narrower than on the base end side.

[0058] In this embodiment, the proximal end side of the overhanging portion 112b is made wide, ensuring removal resistance that prevents the gastrostomy catheter 100 from being naturally pushed out of the body and becoming self-removed. Furthermore, the distal end side (the distal end pressure-receiving portion 112a side) of the overhanging portion 112b is made narrow and pentagonal, preventing the accumulation of nutrients that flow out of the supply passage 111 on the inner surface 112b1 of the overhanging portion 112b. This also prevents the fiberscope from getting caught when being inserted into the stomach through the supply passage 111.

[0059] 4B shows the change in cross-sectional shape when the overhanging portion 112b is stretched. By making the cross-sectional shape of the overhanging portion 112b pentagonal, when the distal pressure-receiving portion 112a is separated from the tubular portion 113 and the overhanging portion 112b is stretched, the outer surface 112b2 can be made to have an outwardly convex arc shape. In this embodiment, this reduces the protrusion of the outer corners of the four stretched overhanging portions 112b, and makes the four outer surface 112b2 approximately follow the circumference of a circle centered on the axis of the tubular portion 113, thereby facilitating insertion of the gastrostomy catheter 100 into the fistula 30.

[0060] Returning to Figures 2A-C and Figures 3A and B, a deformation suppression member 112d made of a material (e.g., PTFE resin, etc.) that is harder (less likely to deform) than the material of the main body 110 is embedded in the tip pressure receiving portion 112a of the bumper portion 112.

[0061] To facilitate insertion and removal of the gastrostomy catheter 100 into and from the fistula 30, it is preferable to construct the main body 110, including the bumper 112, from a softer material so that the protruding portion 112b can be stretched more easily. However, the deformation of the bumper 112 is achieved by pressing the tip pressure-receiving portion 112a with the pressing portion 220 of the obturator 200, and the tip pressure-receiving portion 112a must include a through-hole 112c through which a guidewire is inserted to guide the catheter when inserted into the fistula 30. Therefore, if the bumper 112 is made too soft, the through-hole 112c will deform to expand when pressed, causing the pressing portion 220 to pass through the through-hole 112c.

[0062] Therefore, in this embodiment, the deformation suppressing member 112d is embedded in the tip pressure receiving portion 112a by insert molding, and the two are engaged with each other to prevent the pressing portion 220 from being pushed through.

[0063] Fig. 5A is a plan view of the deformation suppressing member 112d, and Fig. 5B is a front view of the deformation suppressing member 112d. The deformation suppressing member 112d is a disk-shaped member that has a circular central hole 112d1 that penetrates in the thickness direction at the center, so that the through-hole 112c is not blocked.

[0064] In this embodiment, the deformation suppression member 112d is formed by punching a mesh-like flat plate material with a plurality of circular mesh holes 112d2 that penetrate through the thickness. By using a mesh-like material for the deformation suppression member 112d in this way, the engagement force with the tip pressure-receiving portion 112a can be increased, making it possible to reliably achieve the deformation suppression effect.

[0065] In this embodiment, the positioning ability of the positioning recess 112c1 is improved by setting the inner diameter of the central hole 112d1 larger than that of the through-hole 112c and substantially the same as the outer diameter of the positioning portion 221 of the pressing portion 220. Furthermore, in this embodiment, the outer diameter of the deformation suppression member 112d is set slightly larger than the outer diameter of the pressing portion 220, so that the pressing force from the pressing portion 220 can be reliably received by the tip pressure receiving portion 112a.

[0066] FIG. 5C is a plan view showing another example of the configuration of the deformation suppression member 112d. The shape of the deformation suppression member 112d is not limited to a disk shape, and various shapes that can appropriately suppress deformation of the tip pressure receiving portion 112a can be adopted. For example, as shown in FIG. 5C, the deformation suppression member 112d may have four rectangular extension portions 112d3 extending toward the protruding portion 112b, which can further increase the engagement force with the tip pressure receiving portion 112a. In this case, the extension portions 112d3 may be entirely located within the range of the tip pressure receiving portion 112a, or may be partially located within the range of the protruding portion 112b.

[0067] Although not shown, the shape of the mesh holes 112d2 is not particularly limited and may be, for example, a square shape. Instead of the mesh holes 112d2, an appropriate uneven shape may be provided in the deformation suppressing member 112d. If sufficient engagement force can be obtained with the central hole 112d1 alone, the mesh holes 112d2 and uneven shape may not be provided. The material of the deformation suppressing member 112d is not particularly limited and may be, for example, a metal such as stainless steel.

[0068] Furthermore, the deformation suppression member 112d does not necessarily have to be entirely embedded, but may be partially exposed, for example, on the inside of the bumper portion 112 or inside the through-hole 112c, and depending on the shapes of the tip pressure receiving portion 112a and the protruding portion 112b, may be engaged with the tip pressure receiving portion 112a without being embedded.

[0069] 2A to 2C and 3A and 3B, in this embodiment, the provision of deformation suppression member 112d increases the degree of freedom in the design of the shape of bumper portion 112. In other words, the wider range of materials available for main body portion 110 makes it possible to design bumper portion 112 with a short axial dimension L (see FIG. 2B) so that it is less likely to come into contact with stomach wall 20 on the side opposite fistula 30, even when peristaltic movement of the stomach or contractions during hunger occur. Furthermore, it is possible to incorporate innovations into the design, such as varying the width dimension of overhanging portion 112b in the axial direction or making the cross-sectional shape pentagonal.

[0070] Furthermore, in this embodiment, by embedding the entire deformation suppression member 112d within the material of the tip pressure receiving portion 112a, it is possible to reliably achieve the deformation suppression effect even while making it a thin, flat plate, and the provision of the deformation suppression member 112d prevents an increase in the axial dimension L of the bumper portion 112. Furthermore, it is possible to make the shape of the tip pressure receiving portion 112a and its surrounding area, where nutrients are likely to accumulate, into a smooth shape that makes it difficult for nutrients to accumulate.

[0071] Flange portion 114 is a portion that prevents gastrostomy catheter 100 from entering the body by projecting radially outward beyond tubular portion 113. Flange portion 114 has an oval shape in plan view, and the tip side that comes into contact with the patient's skin surface is formed into a smooth dome shape. In other words, flange portion 114 is configured in a shape that has a specific radial direction of tubular portion 113 as its longitudinal direction.

[0072] Cap portion 115 is a portion that closes supply passage 111 by being inserted into check valve portion 130. Cap portion 115 is configured in a cylindrical shape with a tip surface (the upper end surface in FIG. 2B) that bulges out in a hemispherical shape, and a circumferentially continuous locking rib 115a is provided on the tip side of the outer circumferential surface. This locking rib 115a is engaged with locking groove 132 of check valve portion 130 to position cap portion 115 and prevent it from accidentally falling off.

[0073] The cap portion 115 is connected to the flange portion 114 via a strip-shaped connecting portion 115b to prevent loss, etc. The cap portion 115 also includes a tab 115c formed by widening and extending the connecting portion 115b to facilitate handling.

[0074] Connector section 120 engages with engaging sections 320, 422 of stopper 300 and supply tube 400, which are the connection counterparts, thereby connecting stopper 300 and supply tube 400 in a locked state (a state in which they cannot be easily removed) to gastrostomy catheter 100. Connector section 120 is made of an appropriate resin (e.g., PEEK resin) that is harder than main body section 110, and is engaged with main body section 110 by embedding a portion of its tip side into flange section 114 by insert molding.

[0075] Fig. 6A is a plan view of connector portion 120, Fig. 6B is a front view of connector portion 120, Fig. 6C is a bottom view of connector portion 120, and Fig. 6D is a left side view of connector portion 120. Connector portion 120 is composed of a cylindrical tube portion 121 and two tongue-shaped tongue portions 122 extending radially from the tip side of the outer circumferential surface of tube portion 121.

[0076] The tip end portion of the tubular portion 121 is embedded in the flange portion 114, and the base end portion is exposed from the flange portion 114 and engages with the engaging portions 320, 422. The tongue-shaped portion 122 is embedded entirely in the flange portion 114, thereby increasing the engaging force with the main body portion 110. The tip end portion of the tubular portion 121 and the tongue-shaped portion 122 are provided with a plurality of locking holes 123 that penetrate in the thickness direction, thereby increasing the engaging force with the main body portion 110.

[0077] Two rib-shaped engaged portions 124 with which the engaging portions 320, 422 engage are provided on the outer peripheral surface of the exposed portion of the cylindrical portion 121. The engaged portions 124 are provided to extend in the circumferential direction of the cylindrical portion 121 and are composed of a guide portion 124a that is inclined with respect to the circumferential direction so as to guide the engaging portions 320, 422 toward the tip side as the engaging portions 320, 422 rotate around the axis of the cylindrical portion 121, a holding portion 124b that extends in the circumferential direction so as to hold the engaging portions 320, 422 in a predetermined locked position, and a restricting portion 124c that restricts further rotation of the engaging portions 320, 422 by abutting against the engaging portions 320, 422 that have reached the holding portion 124b.

[0078] In this embodiment, similar to a general fastener, the engaged portion 124 is configured so that clockwise rotation in a plan view moves the engaging portions 320, 422 from the guiding portion 124a to the holding portion 124b. Therefore, the guiding portion 124a is provided on the counterclockwise circumferential side of the holding portion 124b in a plan view. The surface of the guiding portion 124a on the main body portion 110 side (the side opposite the connecting partner, the lower side in FIGS. 6B and 6D) is inclined so as to be gradually positioned closer to the connecting partner side (the upper side in FIGS. 6B and 6D) as it moves away from the holding portion 124b in the circumferential direction of the tubular portion 121, so as to contact the engaging ends 321, 422a of the engaging portions 320, 422 and guide them to the holding portion 124b.

[0079] Holding portion 124b is configured to be located closer to the connection partner than engaging ends 321, 422a, thereby preventing the connection partner from moving in a direction away from connector portion 120. The surface of holding portion 124b on the main body portion 110 side is provided along a plane perpendicular to the axis of tubular portion 121 so as to make stable contact with engaging ends 321, 422a.

[0080] The restricting portion 124c is provided on the clockwise side in the circumferential direction relative to the holding portion 124b in a plan view. The restricting portion 124c is provided so as to protrude further toward the main body portion 110 than the holding portion 124b, and this protruding portion abuts against the engaging end portions 321, 422a, thereby restricting the clockwise rotation of the engaging portions 320, 422 in a plan view.

[0081] In this embodiment, the surface of restricting portion 124c on the mating side is inclined so as to be gradually positioned closer to main body 110 as it becomes more spaced from holding portion 124b in the circumferential direction of tubular portion 121. In this manner, when engaging end portions 321, 422a come into contact with the surface of restricting portion 124c on the mating side when stopper 300 or supply tube 400 is connected, engaging end portions 321, 422a can be guided to a position (a position closer to main body 110 than guide portion 124a) where they can be guided by the surface of guide portion 124a of the other engaged portion 124 on the main body 110 side.

[0082] The two engaged portions 124 are arranged at equal intervals in the circumferential direction of the tubular portion 121 in accordance with the two engaging portions 320, 422, and therefore the restricting portion 124c is located on the counterclockwise side in the circumferential direction in a plan view relative to the guiding portion 124a of the other engaged portion 124. The restricting portion 124c also protrudes further toward the main body portion 110 than the holding portion 124b, making it a suitable location for providing an inclined surface that gradually moves closer to the main body portion 110 as it moves away from the holding portion 124b.

[0083] In this embodiment, such a regulating portion 124c is effectively utilized, and in addition to functioning as a stopper that abuts against the engaging ends 321, 422a, it is also given the function of guiding the engaging ends 321, 422a to a position where they can be guided by the guiding portion 124a of the other engaged portion 124, thereby facilitating connection to the other connection partner without complicating the structure of the connector portion 120.

[0084] Furthermore, in this embodiment, the surface of guiding portion 124a on the connection partner side is inclined so as to be gradually positioned closer to the connection partner as it moves away from holding portion 124b in the circumferential direction of tubular portion 121, similar to the surface on the main body portion 110 side. Also, by making the surface of holding portion 124b on the connection partner side follow a plane perpendicular to the axis of tubular portion 121, similar to the surface on the main body portion 110 side, the surface of guiding portion 124a on the connection partner side and the surface of restricting portion 124c on the connection partner side are smoothly connected.

[0085] In this way, even when engaging end portions 321, 422a come into contact with the surface of any portion of engaged portion 124 on the connection partner side, by rotating engaging portions 320, 422 around the axis of tubular portion 121 so as to align with engaged portion 124, engaging end portions 321, 422a can be guided to a position where they can be guided by the surface of guide portion 124a of the other engaged portion 124 on the main body portion 110 side. As a result, connector portion 120 of this embodiment can engage engaged portion 124 and engaging portions 320, 422 without strictly aligning their relative positions, making it possible to easily connect the connection partner.

[0086] 6E is a front view showing another example of the configuration of connector portion 120. Connector portion 120 is not limited to being fixed to main body portion 110 by insert molding, and may be fixed to main body portion 110 by adhesion or welding. In this case, in order to increase the engagement force against rotation of engagement portions 320, 422, it is preferable to provide an engagement structure that appropriately engages with main body portion 110, such as two engagement protrusions 125 shown in FIG. 6E.

[0087] 2A-C and 3A and B, the check valve 130 blocks the base end of the supply passage 111, thereby preventing the outflow of nutrients and the like from inside the stomach to the outside of the body, while allowing the inflow of nutrients from the supply tube 400 into the stomach.

[0088] In this embodiment, check valve unit 130 is configured as a typical duckbill valve including two valve bodies 131 that are gradually closer to each other toward the tip end. That is, check valve unit 130 normally closes pipe portion 113 (more specifically, the base end side of supply passage 111) by the tips of two valve bodies 131 abutting against each other. When valve opening portion 311 of stopper 300 or valve opening portion 421 of supply tube 400 is inserted into check valve unit 130 from the base end side, two valve bodies 131 and their surrounding areas elastically deform appropriately, pushing open two valve bodies 131 and opening pipe portion 113 (more specifically, the base end side of supply passage 111).

[0089] Check valve portion 130 is made of a suitable relatively soft resin (for example, silicone resin). Therefore, the resistance force (recovery force of elastic deformation) when valve-opening portions 311, 421 push open two valve bodies 131 is relatively small. This resistance force acts in a direction that moves stopper 300 or supply tube 400 axially away from connector portion 140, and appropriately presses engaging ends 321, 422a against engaged portion 124. As a result, guiding portion 124a guides engaging ends 321, 422a smoothly with relatively low friction.

[0090] The check valve portion 130 is fixed by being adhered to the main body portion 110 inside the connector portion 120. That is, in this embodiment, a stepped cylindrical portion that protrudes from the flange portion 114 toward the base end side is interposed between the connector portion 120 and the check valve portion 130 (see FIG. 3B). In addition, a circumferentially continuous locking groove 132 is provided on the inner circumferential surface of the check valve portion 130 on the base end side of the valve body 131. This locking groove 132 locks with a locking rib 115a of the cap portion 115, thereby positioning the cap portion 115 at a position where the valve body 131 will not open and preventing the cap portion 115 from accidentally falling off.

[0091] 7A and 7B are diagrams showing a method for connecting the gastrostomy catheter 100 and the stopper 300. To connect the gastrostomy catheter 100 and the stopper 300, first, as shown in Fig. 7A, the stopper 300 is brought close to the gastrostomy catheter 100 in the axial direction, and the open valve portion 311 is inserted into the check valve portion 130.

[0092] Next, the stopper 300 is rotated about its axis so that the engaging portion 320 and the engaged portion 124 engage with each other. This rotation guides the engaging end 321 of the engaging portion 320 into the guide portion 124a, increasing the insertion depth of the valve-opening portion 311 and opening the check valve portion 130. When the engaging end 321 reaches the holding portion 124b and abuts against the restricting portion 124c, the valve-opening portion 311 is properly fitted to the inner circumferential surface of the check valve portion 130. This completes the connection between the gastrostomy catheter 100 and the stopper 300, as shown in FIG. 7B.

[0093] As described above, in this embodiment, even if the engaging end 321 does not fall between the two engaged portions 124 and abuts against the surface of the engaged portion 124 on the stopper 300 side, by rotating the stopper 300 around its axis while lightly pressing the engaging end 321 against the engaged portion 124, it is possible to guide the engaging end 321 to a position where it is guided by the surface of the guiding portion 124a on the main body portion 110 side.

[0094] In this embodiment, the gastrostomy catheter 100 and the stopper 300 can be connected by simply rotating them approximately around the axis, with almost no axial force being applied to them. Furthermore, by providing the engaged portion 124 on the outer peripheral surface of the tubular portion 121 and configuring the engaging portion 320 as two J-shaped arms, the connection state can be easily confirmed. Furthermore, in this embodiment, by positioning the engaged portion 124 so that the longitudinal direction of the force-receiving portion 330 and the longitudinal direction of the flange portion 114 are approximately aligned when the stopper 300 is connected to the gastrostomy catheter 100, handling of the connected gastrostomy catheter 100 and stopper 300 is simplified.

[0095] For example, an appropriate protrusion protruding outward may be provided on the outer peripheral surface of engaged portion 124, and engaging portion 320 may reach holding portion 124b after climbing over this protrusion. In this case, when engaging portion 320 climbs over this protrusion, a clicking sensation can be generated by the restoring force of the elastic deformation of engaging portion 320 or connector portion 120, thereby informing the user through the sensation at their fingertips that the connection has been properly completed. Furthermore, in this embodiment, connector portion 120 is used for both connection with stopper 300 and connection with supply tube 400, and therefore the same effect can be achieved when connecting supply tube 400.

[0096] 8 and 9 are diagrams showing a method for deforming the bumper portion 112. When inserting the gastrostomy catheter 100 into the fistula 30 or removing it from the fistula 30, it is necessary to use the obturator 200 to deform the bumper portion 112 so that it can pass through the fistula 30.

[0097] To deform the bumper portion 112, first, as described above, the stopper 300 is connected to the gastrostomy catheter 100. Next, as shown in Fig. 8, the pressing portion 220 of the obturator 200 is inserted from the base end side through the stopper 300 into the supply passage 111 of the gastrostomy catheter 100, and the tip of the pressing portion 220 is brought into contact with the tip pressure-receiving portion 112a of the bumper portion 112. At this time, the positioning portion 221 enters the positioning recess 112c1, thereby appropriately positioning the pressing portion 220 relative to the tip pressure-receiving portion 112a.

[0098] When inserting the pressing part 220, the check valve part 130 is opened in advance by the valve opening part 311 of the stopper 300, so the user can smoothly insert the pressing part 220 into the supply passage 111. In addition, the check valve part 130 is prevented from being damaged by the pressing part 220.

[0099] When the pressing portion 220 abuts against the distal end pressure-receiving portion 112a, the stopper 300 is moved toward the proximal end of the obturator 200. At this time, the user can easily move the stopper 300 by applying force to the force-receiving portion 231 of the obturator 200 and the force-receiving portion 330 of the stopper 300.

[0100] As the stopper 300 moves, the bumper portion 112 is deformed so as to be stretched in the axial direction. When the stopper 300 approaches the gripping portion 230 of the obturator 200, the stopper 300 is rotated appropriately about the axis to insert the locking protrusion 313 into the introduction portion 233a of the locking groove 233.

[0101] Then, when the locking projection 313 abuts against the inner end of the locking groove 233, the stopper 300 is rotated appropriately about its axis to insert the locking projection 313 into the locking portion 233b of the locking groove 233. As a result, as shown in Fig. 9, the locking projection 313 is locked in the locking groove 233, and the bumper portion 112 is thereby held in its stretched and deformed state.

[0102] In this embodiment, when the locking protrusion 313 enters and locks into the locking portion 233b, the locking groove 233 is configured so that the longitudinal directions of the force receiving portion 231 of the obturator 200 and the force receiving portion 330 of the stopper 300 (and the flange portion 114 of the gastrostomy catheter 100) are substantially aligned. This facilitates the operation of stretching the bumper portion 112 and the operation of connecting the obturator 200 and the stopper 300, and improves operability when inserting the gastrostomy catheter 100 with the stretched bumper portion 112 into or removing it from the fistula 30.

[0103] 9 is not necessarily accurate. As with the engaged portion 124, an appropriate protrusion may be provided in the locking groove 233 so that the locking protrusion 313 passes over this protrusion before entering the locking portion 233b.

[0104] As described above, in this embodiment, by arranging the deformation suppressing member 112d on the tip pressure receiving portion 12a, it is possible to stably deform the bumper portion 112 without causing unnecessary deformation or damage to the tip pressure receiving portion 12a, even with the pressing portion 220 having a relatively small outer diameter. Furthermore, by providing the deformation suppressing member 112d, it is possible to make the main body portion 110 from a softer material and stretch and deform the bumper portion 112 so that the protrusion from the pipe portion 113 is sufficiently small.

[0105] Furthermore, in this embodiment, the cross-sectional shape of the protrusion 112b is configured such that the inner surface 112b1 is a pentagonal angle, so that when the bumper portion 112 is stretched and deformed, the outer surface 112b2 becomes an arc-shaped surface that convex outward, thereby making it possible to reduce the angularity of the outer shape of the bumper portion 112 in the stretched state.

[0106] Therefore, in this embodiment, the gastrostomy catheter 100 can be smoothly inserted into the fistula 30 simply by applying a lubricant while the bumper portion 112 is deformed by the obturator 200 and the stopper 300, greatly reducing the burden on the patient. Note that the gastrostomy catheter 100 is inserted into the fistula 30 with a guide wire that has been inserted into the fistula 30 in advance being inserted through the gastrostomy catheter 100 and the obturator 200.

[0107] Furthermore, in this embodiment, by leaving the stopper 300 connected to the gastrostomy catheter 100 even after placement of the gastrostomy catheter 100, it is possible to keep the check valve section 130 in an open state. Therefore, in this embodiment, the state of the bumper section 112 can be easily checked using a fiberscope inserted into the stomach from the supply passage 111 without using a separate part for opening the check valve section 130.

[0108] Furthermore, in this embodiment, by ensuring a tight seal between the valve opening portion 311 and the check valve portion 130 of the stopper 300, it is possible to inject and discharge or aspirate a coloring liquid (diluted indigo carmine solution) through the cylindrical body portion 310 of the stopper 300. As a result, in this embodiment, confirmation of the placement state by the sky blue method (confirmation that the gastrostomy catheter 100 has reached the stomach) can also be easily performed without reconnecting a dedicated tube or the like to the gastrostomy catheter 100. Note that the sky blue method may be made even easier by providing a connector to which a syringe or the like can be connected at an appropriate position, such as the insertion portion 312 of the stopper 300.

[0109] 10 is a schematic diagram showing a gastrostomy catheter 100 placed in a patient. The gastrostomy catheter 100 is placed with the tube portion 113 inserted through a fistula 30 formed to penetrate the abdominal wall 10 and the stomach wall 20, the bumper portion 112 positioned inside the stomach, and the flange portion 114 and connector portion 120 positioned outside the body.

[0110] As described above, in this embodiment, the bumper portion 112 is sized to be unlikely to come into contact with the stomach wall 20a on the opposite side of the fistula 30 during peristaltic movement or contraction of the stomach, making it less likely that ulcers or the like will occur due to contact with the stomach wall 20. In addition, the flange portion 114 has a dome-like shape on the skin 11 side, making it less likely that pain, inflammation, or the like will occur due to contact with the skin 11.

[0111] The supply tube 400 is connected to the gastrostomy catheter 100 by engaging the engaging portion 422 with the engaged portion 124, similar to the stopper 300. Therefore, the user can attach and detach the distal connector portion 420 by merely rotating it, with almost no force being applied in the axial direction of the gastrostomy catheter 100. In other words, when connecting or detaching the distal connector portion 420, the user hardly needs to push or pull the distal connector portion 420 against the patient, which reduces the patient's pain.

[0112] Furthermore, in this embodiment, the engaging portion 422 and the engaged portion 124 can be engaged without regard to their relative positions, so that the gastrostomy catheter 100 or the supply tube 400 does not have to be moved roughly to adjust their relative positions, which also reduces the burden on the patient.

[0113] Furthermore, in this embodiment, by devising the positioning of the engaged portion 124, when the gastrostomy catheter 100 is connected to the supply tube 400 (when the engaging end 422a is located at the holding portion 124b), the flexible tube portion 410 extends in substantially the same direction as the longitudinal direction of the flange portion 114. By doing so, if the gastrostomy catheter 100 tends to tilt relative to the fistula 30, for example, due to the flexible tube portion 410 being pulled, this tilt can be suppressed by utilizing the large protruding portion of the flange portion 114. This reduces pressure on the fistula 30 and its surrounding area that may accompany tilting of the gastrostomy catheter 100, thereby reducing the risk of inflammation, excessive granulation, and the like, and making it possible to reduce the burden on the patient.

[0114] The nutrient solution supplied from the supply tube 400 passes through the supply passage 111 and then flows into the stomach through the protruding portion 112b of the bumper portion 112. In this embodiment, the distal end of the protruding portion 112b is narrower than the proximal end, and the cross section of the protruding portion 112b is pentagonal, allowing the nutrient solution to flow smoothly. In addition, in this embodiment, the engagement structure of the connector portion 120 is composed of two engaged portions 124 arranged circumferentially spaced apart on the outer circumferential surface of the tubular portion 121, which makes it easier to clean the connector portion 120 and allows the gastrostomy catheter 100 to be kept clean.

[0115] When removing the gastrostomy catheter 100 from the patient, the stopper 300 is connected to the indwelling gastrostomy catheter 100 in the same manner as during insertion, the bumper portion 112 is deformed using the obturator 200, and the gastrostomy catheter 100 is then removed from the fistula 30. When a new gastrostomy catheter 100 is to be placed after removal, the guide wire to be used for the next insertion is inserted into the obturator 200 and through-hole 112c after the pressing portion 220 abuts against the tip pressure-receiving portion 112a.

[0116] As described above, in this embodiment, the bumper portion 112 is stretched to be sufficiently thin, so that removal imposes little strain on the patient. Furthermore, when deforming the bumper portion 112, it is not necessary to insert a hook-type stopper between the flange portion 114 and the skin 11, as is the case with conventional gastrostomy catheters. Therefore, even when subcutaneous fat increases after the initiation of gastrostomy and the flange portion 114 is partially embedded in the abdominal wall 10, or when inflammation occurs around the fistula 30, the patient is less burdened during removal. Note that in this embodiment, the flange portion 114 has a shape that allows the use of conventional hook-type stoppers, thereby increasing the versatility of the gastrostomy catheter 100.

[0117] In this way, the gastrostomy catheter 100 and gastrostomy kit 1 of this embodiment can reduce the burden on the patient at the time of insertion, placement, and removal.

[0118] Next, a gastrostomy kit 2 according to a second embodiment of the present invention will be described. In the following description, the same parts as those in the first embodiment will be given the same reference numerals and their description will be omitted, and only the parts that differ from the first embodiment will be described.

[0119] 11 is a front view showing the configuration of the gastrostomy kit 2. The gastrostomy kit 2 includes a gastrostomy catheter 102, an obturator 202, a stopper 302, and a supply tube 402.

[0120] Fig. 12A is a plan view of the gastrostomy catheter 102, Fig. 12B is a front view of the gastrostomy catheter 102, and Fig. 12C is a bottom view of the gastrostomy catheter 102. Also, Fig. 13A is a left side view of the gastrostomy catheter 102, and Fig. 13B is a cross-sectional view taken along line CC in Fig. 12A.

[0121] In the gastrostomy catheter 102 of this embodiment, the protrusion of the protruding portion 112b of the main body 110 is slightly smaller than in the first embodiment, and the area of ​​the pentagonal cross-section is slightly smaller. The diameter of the tubular portion 113 is also slightly reduced and it has been extended. The shape of the flange portion 114 in a plan view is configured as an octagon, and the shape of the cap portion 115 has been changed to match the connector portion 120 and check valve portion 130 of this embodiment. A connector portion 140 having a different configuration from that of the first embodiment is provided on the base end side of the main body 110.

[0122] 14A is a plan view of connector portion 140, FIG. 14B is a front view of connector portion 140, FIG. 14C is a bottom view of connector portion 140, FIG. 14D is a left side view of connector portion 120, and FIG. 14E is a cross-sectional view along line DD in FIG. 14A.

[0123] The connector portion 140 includes a double-cylindrical tubular portion 141. The tubular portion 141 is composed of an inner tubular portion 141a on the radially inner side and an outer tubular portion 141b on the radially outer side, and the two are connected at the end portion on the base end side. The outer circumferential surface of the inner tubular portion 141a and the inner and outer circumferential surfaces of the outer tubular portion 141b are provided with flat portions corresponding to the shape of the flange portion 114 in a plan view. An engaged portion 144 is provided on the inner circumferential surface of the inner tubular portion 141a.

[0124] The engaged portion 144 is configured by partially protruding two opposing locations on the inner circumferential surface of the inner cylindrical portion 141a. As in the first embodiment, the engaged portion 144 is configured from a guide portion 144a, a holding portion 144b, and a restricting portion 144c. In addition, a space is provided between the two engaged portions 144 for inserting engaging portions 320, 422 that engage with the engaged portion 144.

[0125] The guide portion 144a has a stepped surface (facing the tip) that is inclined relative to the circumferential direction to guide the engaging portions 320, 422 toward the tip. The retaining portion 144b has a stepped surface (facing the tip) along the circumferential direction to retain the engaging portions 320, 422 in a predetermined locking position. The restricting portion 144c is formed over the entire axial length of the inner cylindrical portion 141a to restrict further rotation of the engaging portions 320, 422 by abutting against the engaging portions 320, 422 that have reached the retaining portion 144b.

[0126] By providing the engaged portion 144 on the inner peripheral surface of the tubular portion 141 (of the inner tubular portion 141a), it is possible to make the outer peripheral surface of the tubular portion 141 (of the outer tubular portion 141b) and the base end surface of the tubular portion 141 smooth, which facilitates cleaning of the gastrostomy catheter 102. Furthermore, it is possible to use the outer peripheral surface or base end surface of the tubular portion 141 as a surface on which various information such as product number and size can be displayed by printing, engraving, etc., which improves the ease of handling and safety of the gastrostomy catheter 102.

[0127] Furthermore, in this embodiment, a protrusion 144d that protrudes further toward the tip side than the holding portion 144b is provided on the holding portion 144b side of the guide portion 144a. That is, in this embodiment, when the engagement portions 320, 422 move over the protrusion 144d and enter the holding portion 144b from the guide portion 144a, a clicking sensation is generated by the restoring force of the elastic deformation of the check valve portion 130 that has been pushed open by the valve-opening portions 311, 421.

[0128] By generating a clicking sensation in this way, it is possible to notify the user through the sensation at their fingertips that the connection has been properly completed, but by utilizing the restoring force of elastic deformation in check valve portion 130, which is made of a relatively soft material, it is possible to reduce wear between engaging portions 320, 422 and engaged portion 144 while still generating a clicking sensation. Furthermore, since it is possible to reduce the increase in operating force that accompanies the generation of a clicking sensation, it is possible to prevent excessive force from being applied to fistula 30 when connecting supply tube 400.

[0129] In this embodiment, the protrusion 144d is formed so as to smoothly continue with the inclined surface of the guiding portion 144a; in other words, the end of the guiding portion 144a on the holding portion 144b side is made to protrude further toward the tip side than the holding portion 144b to form the protrusion 144d, thereby realizing a smooth connection operation; however, it goes without saying that a wedge-shaped, dome-shaped, or other protrusion 144d may be separately provided on the inclined surface connected to the holding portion 144b.

[0130] Two engagement protrusions 145 are provided on the tip side of the outer cylindrical portion 141b. That is, the connector portion 140 is fixed to the main body portion 110 by adhesive. The two engagement protrusions 145 are each configured in an L shape that extends toward the tip side and then extends radially outward.

[0131] 13B, the engaging protrusion 145 is accommodated in an accommodating recess 114a provided in the flange portion 114. The accommodating recess 114a is configured to have a shape complementary to the engaging protrusion 145, thereby increasing the engagement force between the main body portion 110 and the connector portion 140. In this embodiment, the provision of the deformation suppression member 112d allows the main body portion 110 to be made of a softer material. Therefore, even if the accommodating recess 114a is configured to have a shape complementary to the L-shaped engaging protrusion 145, the engaging protrusion 145 can be easily pushed into the accommodating recess 114a when assembling the gastrostomy catheter 102.

[0132] 12A-C and 13A and B, check valve portion 130 of the present embodiment is configured from a typical duckbill valve, as in the first embodiment, but differs from the first embodiment in that it is provided with reduced-diameter portion 133, the inner diameter of which is reduced, on the base end side in order to improve the sealing performance between valve-opening portions 311, 421. Furthermore, check valve portion 130 of the present embodiment does not include locking groove 132, and therefore cap portion 115 of the present embodiment is configured in a shape in which locking rib 115a locks onto engaged portion 144 of connector portion 140.

[0133] Furthermore, the check valve portion 130 of this embodiment is adhered to the main body portion 110 at a position slightly closer to the tip than the connector portion 140, and is fixed such that the flange portion on the base end side is pressed in the axial direction by the inner tubular portion 141a of the connector portion 140. Therefore, in this embodiment, unlike the first embodiment, the circumferential boundary between the check valve portion 130 and the main body portion 110 is covered by the connector portion 140, thereby preventing the accumulation of dust and the like at the boundary portion.

[0134] 11 , in the obturator 202 of this embodiment, the axial dimension of the positioning portion 221 of the pressing portion 220 is configured to be longer than in the first embodiment, and four axially extending ribs 221a are provided on the proximal end side of the outer peripheral surface of the positioning portion 221. In this embodiment, providing four ribs 221a in this manner enables stable positioning even when the through hole 112c and the positioning recess 112c1 in the distal end pressure receiving portion 112a of the bumper portion 112 are large. That is, the pressing portion 220 of this embodiment has an increased outer diameter on the proximal end side of the positioning portion 221, thereby expanding the range of applicable shapes of the distal end pressure receiving portion 112a and improving the versatility of the obturator 202.

[0135] The grip portion 230 also has two locking pieces 235 instead of the locking groove 233 of the first embodiment. The locking pieces 235 are provided so as to extend toward the tip side from portions that protrude toward one and the other longitudinal sides of the force receiving portion 231 at the base end side of the accommodating portion 232. The tip side of the locking piece 235 is provided with a wedge-shaped locking protrusion 235a that protrudes toward the outside in the radial direction of the accommodating portion 232 and gradually decreases in protrusion amount toward the tip side. The base end side of the locking piece 235 is provided with a restricting protrusion 235b that protrudes toward the outside in the radial direction of the accommodating portion 232 and gradually decreases in protrusion amount toward the base end side.

[0136] The locking protrusion 235a is a portion that locks onto the stopper 302, and the restricting protrusion 235b restricts the axial movement of the obturator 202 after the locking protrusion 235a locks onto the stopper 302. In addition, the restricting protrusion 235b is also a portion that the user presses when elastically deforming the locking piece 235 to release it from the stopper 302, and therefore is appropriately provided with an uneven shape to prevent slipping.

[0137] Furthermore, instead of the communication groove 234 in the first embodiment, the gripping portion 230 has an internal cavity 236 that communicates with the interior of the thin tube portion 210, and this cavity 236 has an opening 236a that opens over a wide area from the base end side of the gripping portion 230 to one side in the longitudinal direction of the force receiving portion 231. In this embodiment, by providing the cavity 236 that opens over a wide area toward the outside in this manner, the degree of freedom in handling the guidewire is further increased. Furthermore, in this embodiment, the portions on both ends in the longitudinal direction of the force receiving portion 231 are gently curved toward the tip side, thereby making it a shape that fits comfortably in the palm of your hand, and making it easier to input force into the force receiving portion 231 when stretching the bumper portion 112.

[0138] In the stopper 302 of this embodiment, the axial dimension of the valve-opening portion 311 of the body portion 310 is shorter than in the first embodiment, and a large-diameter portion 314 having a larger diameter than the valve-opening portion 311 is formed between the valve-opening portion 311 and the force-receiving portion 330. In this embodiment, when the stopper 302 is connected to the gastrostomy catheter 102, this large-diameter portion 314 is inserted into and fitted into the reduced-diameter portion 133 of the check valve portion 130, thereby improving the sealing performance between the stopper 302 and the check valve portion 130. Therefore, the outer diameter of the large-diameter portion 314 is set slightly larger than the inner diameter of the reduced-diameter portion 133. Furthermore, the corners at the tip of the large-diameter portion 314 are appropriately rounded to facilitate insertion into the reduced-diameter portion 133.

[0139] By improving the sealing performance of the stopper 302 and the check valve 130, it is possible to prevent leakage of the colored liquid, making it easier to perform the Sky Blue Method via the stopper 302 connected to the gastrostomy catheter 102. Furthermore, it is possible to efficiently send air into the stomach via the stopper 302 connected to the gastrostomy catheter 102, making it easier to observe the inside of the stomach while it is in an inflated state. In this embodiment, the insertion section 312 is provided with a female luer section 312a to which a syringe or the like can be connected, making these procedures even easier.

[0140] In stopper 302, engaging portion 320 is configured as a truncated quadrangular pyramid-shaped protrusion that protrudes radially outward from body portion 310 to match connector portion 140. More specifically, engaging portion 320 is configured as a truncated quadrangular pyramid-shaped protrusion whose tip-side surface is gradually inclined away from the tip side toward the apex. Engaging portions 320 are provided at two locations on the tip side of the outer peripheral surface of large diameter portion 314, each offset by approximately 80 degrees counterclockwise in plan view from positions corresponding to one side and the other side of force receiving portion 330 in the longitudinal direction.

[0141] Further, stopper 302 has two locking beams 340 instead of locking protrusion 313 in the first embodiment. Fig. 15A is a plan view of stopper 302, and Fig. 15B is a left side view of stopper 302.

[0142] On the front and back sides of the insertion portion 312 of the stopper 302, there are provided support portions 341 each having a horizontally elongated wall plate shape that protrudes from the force receiving portion 330 toward the base end and extends along the longitudinal direction of the force receiving portion 330. The locking beam 340 is provided to connect both ends of the two support portions 341. That is, the stopper 302 is configured so that the locking piece 235 of the obturator 202 is inserted between the two support portions 341, thereby locking the locking protrusion 235a to the locking beam 340, and the two support portions 341 restrict the relative rotation (rotation around the axis) of the obturator 202 and the stopper 302.

[0143] The two support portions 341 have their longitudinal ends bent toward the base end so that the distance between them gradually increases toward the base end in order to appropriately guide the locking pieces 235. The two support portions 341 are also curved so that their longitudinal intermediate portions bulge toward the front and rear sides in order to avoid interference with the housing portion 232 of the obturator 202. Furthermore, the portions of the two support portions 341 that are distal to the locking beam 340 are notched in a rectangular shape in order to improve the visibility of the locking protrusions 235a locked by the locking beam 340.

[0144] As described above, in this embodiment, by improving the sealing between the check valve portion 130, it is possible to efficiently send air into the stomach via the stopper 302 connected to the gastrostomy catheter 102 and inflate the stomach, but it is also possible to simultaneously send air through the stopper 302 and insert a fiberscope through the stopper 302.

[0145] Figure 15C is a cross-sectional view showing an example of a case where stopper 302 is provided with intake port 350, and is equivalent to the cross-sectional view taken along line EE in Figure 15A. In this example, intake port 350 communicating with insertion hole 310a is provided so as to protrude from the base end side of large diameter portion 314 toward the rear side. Note that although intake port 350 in this example is provided with female luer portion 350a, intake port 350 may be provided with a connector of another shape.

[0146] In this example, an annular shutoff valve 360 ​​is provided inside the body 310 to prevent air from leaking from the insertion portion 312 by coming into close contact with the outer peripheral surface of the fiberscope inserted into the body 310. In this example, the insertion portion 312 is made up of a separate member that is adhesively fixed to the main body 302a of the stopper 302, and the shutoff valve 360 ​​is fixed inside the body 310 by being sandwiched between the insertion portion 312 and the main body 302a.

[0147] Note that the blocking valve 360 ​​in this example is made of an appropriate elastic material (for example, silicone resin, etc.) and is formed into a circular shape with an inner diameter smaller than the outer diameter of the fiberscope by punching out a flat plate-like material, but the blocking valve 360 ​​may also be made of a general O-ring, etc. Also, the stopper 302 may be formed integrally and fitted into a groove provided on the inner circumferential surface of the insertion hole 310a to fix the blocking valve 360. Also, an appropriate check valve may be provided in the intake port 350.

[0148] 11, the supply tube 402 of this embodiment, like the first embodiment, has a valve-opening section 421, a large-diameter section 423, and two engagement sections 422, which have the same configuration as the stopper 302. Therefore, the connection mode of the supply tube 402 to the gastrostomy catheter 102 is the same as the connection mode of the stopper 302. Also, in the supply tube 402, the engagement of the large-diameter section 423 and the reduced-diameter section 133 ensures a tight seal between the tip-side connector section 420 and the check valve section 130.

[0149] 16A and 16B are diagrams showing a method for connecting the gastrostomy catheter 102 and the stopper 302. To connect the gastrostomy catheter 102 and the stopper 302, first, as shown in Fig. 16A, the stopper 302 is positioned so that the engaging portion 320 does not interfere with the engaged portion 144, and then the stopper 302 is brought close to the gastrostomy catheter 100 in the axial direction, and the open valve portion 311 is inserted into the check valve portion 130.

[0150] When the tip of the large diameter portion 314 of the stopper 302 abuts against the reduced diameter portion 133 of the check valve portion 130, the engaging portion 320 is positioned at a position where it can be guided by the guide portion 144a of the engaged portion 144. Therefore, once the user feels that the tip of the large diameter portion 314 has abutted against the reduced diameter portion 133, the user can rotate the stopper 300 about the axis to cause the engaging portion 320 to engage with the engaged portion 144. That is, in this embodiment, the user is notified by the sensation in their fingertips that the engaging portion 320 is now in a state where it can engage with the engaged portion 144, thereby preventing poor connection.

[0151] By rotating the stopper 300 around its axis, the engaging portion 320 moves over the protruding portion 144d and reaches the holding portion 144b. As a result, as shown in FIG. 16B, the connection between the gastrostomy catheter 102 and the stopper 302 is completed. At this time, the user can know that the engaging portion 320 has reached the holding portion 144b by a soft clicking sensation that utilizes the restoring force of the elastic deformation of the check valve portion 130. Also, as with the first embodiment, the provision of the guide portion 144a allows connection with almost no axial force required.

[0152] When the stopper 302 is connected to the gastrostomy catheter 102, the check valve section 130 is pushed open by the valve-opening section 311, and the large-diameter section 314 fits into the reduced-diameter section 133, thereby sealingly connecting the insertion hole 310a inside the stopper 302 to the supply passage 111 inside the gastrostomy catheter 102. This facilitates the supply of air, liquid, etc. via the stopper 302, as described above.

[0153] 17A and 17B are diagrams showing a method for connecting the obturator 202 and the stopper 302 when deforming the bumper portion 112. In this embodiment, the obturator 202 and the stopper 302 are connected by the wedge-shaped locking protrusions 235a locking with the locking beams 340. Therefore, as shown in Fig. 17A, a user can simply apply force to the force receiving portion 231 of the obturator 202 and the force receiving portion 330 of the stopper 302 and bring the obturator 202 and the stopper 302 close to each other, thereby elastically deforming the locking pieces 235 toward the inside in the radial direction of the thin tube portion 210 (and the housing portion 232) due to the pressure from the locking beams 340, and causing the locking protrusions 235a to ride over the locking beams 340.

[0154] 17B , the locking beam 340 is disposed between the locking protrusion 235a and the restricting protrusion 235b, thereby completing the connection between the obturator 202 and the stopper 302. That is, in this embodiment, since the rotation operation around the axis as in the first embodiment is not required, the obturator 202 and the stopper 302 can be connected with only one hand, and the bumper portion 112 can be stretched extremely easily.

[0155] The locking pieces 235 of the obturator 202 may be configured to elastically deform radially outward from the thin tube portion 210. Figures 18A and 18B are diagrams showing an example of a configuration in which the locking pieces 235 of the obturator 202 are configured to elastically deform radially outward from the thin tube portion 210, and show a method of connecting the obturator 202 and the stopper 302 when the bumper portion 112 is deformed.

[0156] In the obturator 202 of this example, the locking protrusion 235a is formed by projecting the tip end of a flat locking piece 235 that is curved so that the radially outer side of the thin tube section 210 is convex toward the radially inner side of the thin tube section 210. The stopper 302 is provided with a wedge-shaped locking wedge 370 that projects radially outward from the body section 310 and whose projection amount gradually decreases toward the base end side.

[0157] Furthermore, inner flat surfaces 232a for preventing rotation are provided on the inner peripheral surface of the accommodation portion 232 of the obturator 202, on one and the other longitudinal sides of the force receiving portion 231. Further, outer flat surfaces 312b for preventing rotation are provided on the outer peripheral surface of the insertion portion 312 of the stopper 302, on one and the other longitudinal sides of the force receiving portion 231 and on one and the other longitudinal sides of the force receiving portion 231 in a direction perpendicular to the longitudinal direction.

[0158] In this example as well, as shown in FIG. 18A , the user simply applies force to the force receiving portion 231 of the obturator 202 and the force receiving portion 330 of the stopper 302, and brings the obturator 202 and the stopper 302 close to each other, whereby the locking piece 235 is elastically deformed radially outward of the thin tube portion 210 by the pressure from the locking wedge 370, and the locking protrusion 235 a is allowed to climb over the locking beam 340.

[0159] Then, after the locking protrusion 235a climbs over the locking wedge 370, the elastic deformation of the locking piece 235 is released, and as shown in FIG. 18B, the locking protrusion 235a is positioned further distal than the locking wedge 370, thereby completing the connection between the obturator 202 and the stopper 302.

[0160] At this time, movement of the obturator 202 and the stopper 302 in directions away from each other is restricted by the abutment of the locking protrusions 235a with the locking wedges 370, and movement of the obturator 202 and the stopper 302 in directions toward each other is restricted by the abutment of the accommodation portion 232 with the locking wedges 370. Furthermore, the restriction by the inner flat surface portion 232a and the outer flat surface portion 312b arranged opposite each other prevents the locking protrusions 235a from coming off the locking wedges 370 due to relative rotation about the axis of the obturator 202 and the stopper 302.

[0161] Even in this case, the user can easily connect the obturator 202 and the stopper 302 with only one hand. To release the connection between the obturator 202 and the stopper 302, the user simply rotates the obturator 202 by approximately 90 degrees around the axis relative to the stopper 302 while elastically deforming the housing portion 232 (and the insertion portion 312) so that the inner flat surface portion 232a faces the other set of outer flat surfaces 312b.

[0162] 19 is a diagram showing the state in which the supply tube 402 is connected to the gastrostomy catheter 102. The supply tube 402 is connected to the gastrostomy catheter 102 by engaging the engaging portion 422 with the engaged portion 144, similar to the stopper 302.

[0163] Therefore, the user can attach or detach the distal connector section 420 to or from the gastrostomy catheter 102 by merely rotating it, with almost no force being applied in the axial direction of the gastrostomy catheter 100. Furthermore, the user can sense with his or her fingertips when the large-diameter section 423 and the reduced-diameter section 133 come into contact and when the engaging section 422 reaches the holding section 144b, allowing for easy and reliable connection.

[0164] Furthermore, by fitting large-diameter section 423 into reduced-diameter section 133, leakage of nutrients into connector section 140 is more reliably prevented, making it possible to maintain gastrostomy catheter 102 placed in a patient in a good hygienic state. Furthermore, by extending flexible tube section 410 in the extension direction of flexible tube section 410 and in the longitudinal direction of flange section 114, tilting of gastrostomy catheter 102 can be effectively suppressed, as in the first embodiment.

[0165] The gastrostomy kit 2 may include a hook-type stopper 500 instead of or in addition to the stopper 302. Fig. 20A is a front view of the stopper 500, and Fig. 20B is a right side view of the stopper 500. Fig. 20C is a view showing the stopper 500 in use when the bumper portion 112 is deformed.

[0166] The stopper 500 is composed of a hook portion 510 that hooks onto the flange portion 114, a force receiving portion 520 that receives force when the bumper portion 112 is deformed, and a connecting portion 530 that connects the hook portion 510 and the force receiving portion 520.

[0167] The hook portion 510 is configured in a fork shape by having a flat plate-like portion on the tip side of the connecting portion 530 protrude obliquely toward the front side and the base end side, and by having a tip-side insertion groove 511 at a midpoint in the width direction. The force receiving portion 520 is provided on the base end side of the connecting portion 530, and is configured in a rectangular flat plate shape with its longitudinal direction perpendicular to the protruding direction of the hook portion 510 and both end portions in the longitudinal direction curved toward the tip side. The base-side insertion groove 521 is provided on the front side of the force receiving portion 520 at a midpoint in the longitudinal direction. The connecting portion 530 is configured in a rectangular flat plate shape bent in a crank shape so that its tip side portion is located on the rear side to avoid interference with the flange portion 114.

[0168] As shown in FIG. 20C , the stopper 500 is configured such that, with the tube portion 113 of the gastrostomy catheter 102 inserted into the distal-end insertion groove 511, the hook portion 510 is hooked onto the flange portion 114, and with a portion of the grip portion 230 of the obturator 202 inserted into the proximal-end insertion groove 521, the force-receiving portion 520 is engaged with an engaging step portion 237 provided on the grip portion 230, thereby maintaining the bumper portion 112 (not shown) in an extended state.

[0169] By providing such a stopper 500 in the gastrostomy kit 2, the locking structure between the obturator 202 and the stopper 500 is simplified, making it possible to arrange multiple locking step portions 237 side by side in the axial direction, as shown in Fig. 20C. This makes it possible to adjust the deformation state of the bumper portion 112 by changing the locking position, and therefore the bumper portion 112 can be deformed in accordance with the patient's condition, etc., when inserting or removing the gastrostomy catheter 102. Furthermore, for example, if a gastrostomy catheter equipped with a connector portion different from the connector portion 140 is indwelling in a patient, it becomes possible to remove this gastrostomy catheter using the obturator 202 and stopper 500 provided in the gastrostomy kit 2. In other words, it becomes possible to exchange a different gastrostomy catheter for the gastrostomy catheter 102 using only the gastrostomy kit 2.

[0170] Since the obturator 200 of the first embodiment also has a locking step portion (see FIG. 1, etc.), it goes without saying that the gastrostoma kit 1 may also be provided with a stopper 500.

[0171] Although the embodiments of the present invention have been described above, the gastrostomy catheter and gastrostomy kit of the present invention are not limited to the above-described embodiments, and various modifications can be made without departing from the spirit and scope of the present invention.

[0172] Furthermore, the actions and effects shown in the above-described embodiments are merely a list of the most preferable actions and effects resulting from the present invention, and the actions and effects of the present invention are not limited to these. [Explanation of symbols]

[0173] 1, 2 Gastrostomy Kit 30 Fistula 100, 102 Gastrostomy catheter 112 Bumper section 112a Tip pressure receiving part 112b Protruding part 112d Deformation suppression member 112d2 mesh hole 113 Pipe section 114 Flange 120, 140 connector part 121, 141 Cylindrical part 124, 144 engaged portion 124a, 144a Induction part 124b, 144b holding part 124c, 144c Regulation Department 144d Protrusion 130 Check valve section 200, 202 Obturator 300, 302, 500 stopper 320, 422 engagement portion 400, 402 supply tube

Claims

1. a tubular tube portion to be inserted into the fistula; a bumper portion provided on the distal end side of the tubular portion and configured to be deformable into a state that allows passage through the fistula, The bumper portion is a tip pressure receiving portion that is disposed at a distance from the tubular portion toward the tip side and receives a pressing force when the tubular portion is deformed; a protruding portion that connects the pipe portion and the tip pressure receiving portion and protrudes radially outward from the pipe portion; a deformation suppression member that is a separate member that engages with the tip pressure-receiving portion.

2. The gastrostomy catheter according to claim 1, A gastrostomy catheter characterized in that at least a portion of the deformation suppression member is embedded in the tip pressure-receiving portion, or at least a portion is embedded in the tip pressure-receiving portion and the protruding portion.

3. The gastrostomy catheter according to claim 2, The gastrostomy catheter is characterized in that the deformation suppression member is formed in a flat plate shape.

4. The gastrostomy catheter according to claim 2 or 3, A gastrostomy catheter, wherein the deformation suppression member has a plurality of holes.

5. The gastrostomy catheter according to claim 1, The gastrostomy catheter is characterized in that the protruding portion has a pentagonal cross-sectional shape perpendicular to the longitudinal direction, at least in a portion of the tip side, with the central portion of the width direction of the inner surface raised to form a mountain shape.

6. The gastrostomy catheter according to claim 1, a connector portion provided on the proximal end side of the tubular portion to which a nutrient supply tube is connected; A gastrostomy catheter characterized in that the connector portion is also used to connect a member that applies a tensile force opposite to the pressing force received by the tip pressure-receiving portion when the bumper portion is deformed.

7. The gastrostomy catheter according to claim 6, The connector portion has a cylindrical portion and an engaged portion that is provided on an outer peripheral surface or an inner peripheral surface of the cylindrical portion and engages with an engaging portion of a connection partner, The engaged portion is a holding portion that is positioned closer to the connecting partner than at least a portion of the engaging portion and holds the connecting partner at a predetermined position in the axial direction of the cylindrical portion; a guide portion provided on one side of the cylindrical portion in the circumferential direction with respect to the holding portion, the guide portion having a surface opposite to the connecting partner that is inclined so as to be gradually positioned toward the connecting partner as the surface becomes more spaced from the holding portion in the circumferential direction of the cylindrical portion; a restricting portion that is provided on the other circumferential side of the tubular portion with respect to the holding portion and that protrudes beyond the holding portion to the side opposite the connection partner.

8. The gastrostomy catheter according to claim 7, a flange portion extending radially outward from the tubular portion at a base end side of the tubular portion, The flange portion is configured to have a shape whose longitudinal direction is a specific radial direction of the pipe portion, the engaged portion is arranged such that, when the connection partner is the supply tube, the supply tube extends in the longitudinal direction of the flange portion when the holding portion holds the supply tube in the predetermined position.

9. The gastrostomy catheter according to claim 7 or 8, a check valve portion that closes the pipe portion, the check valve portion is configured to open the pipe portion by being pushed by the connecting partner and elastically deforming, The gastrostomy catheter is characterized in that the engaged portion has a protrusion that protrudes further from the holding portion on the holding portion side of the guide portion toward the opposite side from the connection partner.

10. The gastrostomy catheter according to claim 1; an obturator that applies a pressing force to the tip pressure-receiving portion when the bumper portion is deformed; a stopper on the base end side of the gastrostomy catheter that applies a tensile force opposite to the pressing force when the bumper portion is deformed.

Images