JP7081173B2 - Balloon type gastric fistula catheter - Google Patents

Description

The present invention relates to a balloon-type gastric fistula catheter.

A gastrostomy leading to the stomach may be created in the abdomen of a patient who cannot eat by mouth (this procedure is called PEG (Percutaneous Endoscopic Gastrostomy)). A tube of a gastric fistula catheter is inserted into the gastric fistula. Through this tube, a liquid nutrient is administered to the patient's stomach.

The gastric fistula catheter is indwelled in the patient for an extended period of time. The gastric fistula catheter is roughly classified into a balloon type and a bumper type according to the type of an internal stopper (fixture) for fixing the tube so as not to come out of the patient. In the balloon type, a balloon capable of expanding and contracting is provided at the tip of the tube. The tube is fixed by injecting water (distilled water) into the balloon and inflating the balloon in the stomach.

The balloon-type gastric fistula catheter is provided with a one-way valve in the flow path communicating with the balloon in order to prevent the backflow of water in the balloon and maintain the inflated state of the balloon. The one-way valve is provided on the body of the gastric fistula catheter, which is placed on the body surface of the patient (see, for example, Patent Document 1). As the one-way valve, a duck bill type one-way valve is advantageous from the viewpoint of downsizing the main body.

Japanese Unexamined Patent Publication No. 2014-161670

When draining water from the balloon to replace the gastric fistula catheter, a one-way valve must be opened. However, in order to open the Duckville type one-way valve, a special tool is required. This complicates the operation for contracting the balloon.

An object of the present invention is to provide a balloon-type gastric fistula catheter in which a one-way valve is not provided in a flow path communicating with a balloon.

The balloon-type gastric fistula catheter of the present invention has a flexible tube provided with a first flow path and a second flow path, and an inflatable and inflatable tube provided at the tip of the tube and communicating with the second flow path. It comprises a deflated balloon and a body connected to the base end of the tube. The main body is a rotatable cock provided with a first hole penetrating the main body and communicating with the first flow path of the tube, a one-way valve provided in the first hole, and a female connector. And. The rotation direction position of the cock is switched between a first position where the cock blocks communication between the balloon and the outside world and a second position where the balloon communicates with the female connector via the second flow path. Can be done.

According to the present invention, the communication between the balloon and the outside world can be switched by switching the rotation direction position of the cock between the first position and the second position. Therefore, in the catheter of the present invention, it is not necessary to provide a one-way valve in the flow path communicating with the balloon. The operation for contracting the balloon can be easily performed without using a dedicated instrument.

Further, since the cock is provided with a female connector, the main body can be miniaturized.

FIG. 1A is a perspective view of a balloon-type gastric fistula catheter according to an embodiment of the present invention. FIG. 1B is a cross-sectional view of a balloon-type gastric fistula catheter along the vertical plane including line 1B-1B of FIG. 1A. FIG. 2 is an exploded perspective view of a balloon-type gastric fistula catheter according to an embodiment of the present invention. FIG. 3A is a perspective view of the main body constituting the balloon-type gastric fistula catheter according to the embodiment of the present invention as viewed from above on the front side. FIG. 3B is a perspective view seen from above the rear side of the main body. FIG. 3C is a side view of the main body. FIG. 3D is a top view of the main body. FIG. 3E is a bottom view of the main body. FIG. 4A is a perspective view of a cock constituting a balloon-type gastric fistula catheter according to an embodiment of the present invention. FIG. 4B is a cross-sectional view taken along a plane including the central axis of the cock. FIG. 5 is a cross-sectional view showing a state in which a syringe is connected to the cock of the balloon-type gastric fistula catheter according to the embodiment of the present invention.

In the above-mentioned balloon-type gastric fistula catheter of the present invention, the position in the rotation direction of the cock is set to the third position where the female connector is communicated with the portion on the first flow path side of the one-way valve of the first hole. Further switching may be possible. According to such an embodiment, it is possible to clean the flow path of the nutritional supplement such as the lower surface of the one-way valve and the inner peripheral surface of the first hole. In addition, since the liquid (for example, water) for cleaning the flow path of the nutrient can be injected from the female connector of the cock, compared with the case where a dedicated connector for injecting the cleaning liquid is provided other than the cock. Therefore, the main body can be miniaturized.

The opening on the first hole side of the flow path that communicates the female connector with the first hole may be configured such that the liquid is ejected from the opening toward the one-way valve. According to such an embodiment, the lower surface of the one-way valve to which dirt easily adheres can be washed with a liquid. Therefore, the flow path of the nutrient can be maintained in a clean state.

The opening on the first hole side of the flow path that communicates the female connector and the first hole is configured so that the liquid jetted from the opening swirls and flows on the inner peripheral surface of the first hole. You may have. According to such an aspect, it is possible to wash with a small amount of unwashed residue. Therefore, the flow path of the nutrient can be maintained in a clean state.

When the cock is in the third position, communication between the balloon and the outside world may be cut off. According to such an embodiment, it is possible to prevent the occurrence of a situation in which the water in the balloon leaks to the outside world and the balloon contracts when the flow path of the nutritional supplement is washed.

When the cock is in the first position and the second position, the cock may cut off communication between the first hole and the female connector. According to such an embodiment, even if the contents of the stomach flow back into the first hole under normal use conditions in which the catheter is placed in the patient, the contents do not leak to the outside from the female connector, and the balloon does not leak to the outside world. During the operation of inflating or contracting the balloon, water for inflating the balloon does not pass through the first hole and flow into the stomach.

When viewed along the central axis of the first hole, the axis of rotation of the cock may be perpendicular to a straight line extending from the central axis. Such an embodiment is advantageous for downsizing the main body.

The female connector may include a female tapered surface coaxial with the rotation axis of the cock. The female tapered surface may be a tapered surface whose inner diameter increases toward the opening. According to such an embodiment, the cock can be rotated by connecting the tip of the syringe to the female connector and rotating the syringe. Therefore, a series of operations necessary for expanding and contracting the balloon and cleaning the flow path of the nutritional supplement can be efficiently performed using only a syringe without using a special instrument.

The catheter of the present invention may include a rotatable angle limiting mechanism that limits the rotatable angle range of the cock. According to this aspect, the second position and the third position can be set at the two limit positions that define the rotatable angle range. This facilitates positioning of the cock in the second and third positions.

Hereinafter, the present invention will be described in detail with reference to suitable embodiments. However, it goes without saying that the present invention is not limited to the following embodiments. For convenience of explanation, each figure referred to in the following description is a simplified representation of the main members constituting the embodiment of the present invention. Therefore, the present invention may include any member not shown in each of the following figures. Further, within the scope of the present invention, each member shown in each of the following figures may be changed or omitted.

FIG. 1A is a perspective view of a balloon-type gastric fistula catheter (hereinafter referred to as “catheter”) 1 according to an embodiment of the present invention. FIG. 1B is a cross-sectional view of the catheter 1 along the plane including the line 1B-1B of FIG. 1A and the central axis of the tube 10. The catheter 1 is a balloon button type gastric fistula indwelled in the patient by inserting the tube 10 into the gastric fistula constructed in the patient's abdomen, inflating the balloon 15 in the stomach, and bringing the main body 20 into close contact with the body surface. It is a catheter. FIG. 1A further shows a male connector 60 connected to the port 22 and a syringe 70 connected to the cock 40. The flexible tube connected to the hole 62 at the top of the male connector 60 is not shown. The liquid nutritional supplement (which may contain a drug or the like) is administered to the patient via the male connector 60. Water for expanding and contracting the balloon 15 (for example, distilled water) is flown in and out of the balloon 15 using a syringe 70. For the convenience of the following explanation, the longitudinal direction of the tube 10 is referred to as "vertical direction", the gastric side (lower side in FIG. 1A) is referred to as "lower" side, and the opposite side (male connector 60 side) is referred to as "upper". It is called the side. The direction parallel to the plane perpendicular to the vertical direction is called the "horizontal direction". However, the "vertical direction" and the "horizontal direction" do not mean the orientation when the catheter 1 is used. Of both ends in the longitudinal direction of the tube 10, the lower end is referred to as the "tip" and the upper end is referred to as the "base end".

FIG. 2 is an exploded perspective view of the catheter 1.

The tube 10 is a double lumen type tube provided with a first flow path 11 and a second flow path 12 independent of each other. The first flow path 11 extends along the longitudinal direction of the tube 10 and is open at both ends of the tube 10 (see FIG. 1B). The first flow path 11 is a flow path for the nutritional supplement to be administered to the patient. One end (upper end) of the second flow path 12 is opened at the base end of the tube 10 as in the first flow path 11. The other end (lower end) of the second flow path 12 is open to the outer peripheral surface of the tube 10 at a position near the tip of the tube 10 so as to communicate with the balloon 15 (not shown). The second flow path 12 is a flow path for water for expanding and contracting the balloon 15. In the present embodiment, the second flow path 12 is provided along the inner wall surface of the first flow path 11.

The balloon 15 is provided on the outer peripheral surface of the tube 10 in a region at a predetermined distance from the tip of the tube 10. The balloon 15 is made of a thin film that is flexible and can be stretched and contracted. 1A, 1B and 2 show a state in which the balloon 15 is inflated. As shown, the balloon 15 expands to expand in diameter like a donut. Although not shown, when the balloon 15 is contracted, the diameter of the balloon 15 is reduced so as to be in close contact with the outer peripheral surface of the tube 10.

The tube 10 is flexible so that it can be easily bent. The material of the tube 10 preferably has biocompatibility in addition to flexibility and is not limited, but for example, silicone rubber or polyurethane elastomer can be used, and silicone rubber is particularly preferable. The balloon 15 can also be constructed using the same material as the tube 10.

3A is a perspective view seen from above the front side of the main body 20, FIG. 3B is a perspective view seen from above the rear side of the main body 20, FIG. 3C is a side view of the main body 20, FIG. 3D is a top view of the main body 20, and FIG. 3E is. It is a bottom view of the main body 20. In FIGS. 3C and 3D, the main internal structures (second hole 30, first connecting flow path 38, second connecting flow path 39, etc.) that cannot be seen from the appearance of the main body 20 are shown by broken lines.

The plan view shape of the main body 20 is substantially rectangular as a whole (see FIG. 3D). More specifically, the two short sides constituting the substantially rectangle project in an arc shape. The main body 20 is provided with a first hole 21 that penetrates the main body 20 in the vertical direction. The first hole 21 has a large diameter portion 21a and a small diameter portion 21b arranged coaxially in this order from top to bottom (see FIGS. 3C and 1B). The inner peripheral surface of the large diameter portion 21a is a cylindrical surface, and the inner diameter thereof is larger than the inner diameter of the small diameter portion 21b.

A one-way valve 23 and a cap 24 are sequentially attached to the large diameter portion 21a of the first hole 21 from above (see FIG. 2), and a port 22 (see FIGS. 1A and 1B) is configured. The one-way valve 23 allows the nutrient to flow from the port 22 towards the patient's stomach, but conversely prevents the stomach contents from leaking out of the port 22 to the outside world. The one-way valve 23 is a valve that allows fluid to flow in only one direction and has a function of preventing backflow, and is also called a check valve or a check valve. The configuration of the one-way valve 23 is not limited as long as it has such a function. In this embodiment, a duck bill type one-way valve is used as the one-way valve 23. The duck bill type one-way valve 23 is advantageous for downsizing the main body 20. The one-way valve 23 is inserted into the first hole 21 so as to close the first hole 21. The cap 24 is an annular member with an open center. The cap 24 is fitted into a circular groove surrounding the first hole 21 in order to fix the one-way valve 23 to the main body 20. The cap 24 defines the opening of the port 22 into which the male luer 61 of the male connector 60 (see FIG. 1A) is fitted. In the present invention, the cap 24 can be omitted. In this case, the opening of the port 22 is defined by the edge of the opening of the first hole 21 or the one-way valve 23.

The connecting cylinder 27 projects downward from the lower surface of the main body 20. The connecting cylinder 27 has a hollow substantially cylindrical shape. As shown in FIG. 3C, the connection cylinder 27 is arranged coaxially with the first hole 21 and communicates with the first hole 21. The inner peripheral surface of the connecting cylinder 27 is a cylindrical surface having a constant inner diameter in the vertical direction. The inner diameter of the connecting cylinder 27 is larger than the inner diameter of the small diameter portion 21b of the first hole 21. Therefore, a stop surface 26 due to the difference in inner diameter is provided between the connection cylinder 27 and the small diameter portion 21b. As shown in FIG. 3E, the stop surface 26 is an annular plane and is parallel in the horizontal direction. A first connecting flow path 38 (details will be described later) is open on the stop surface 26.

As shown in FIG. 1B, the upper end of the tube 10 is inserted into and fixed to the connecting cylinder 27. The upper end surface of the tube 10 and the stop surface 26 are in surface contact with each other, and a liquidtight seal is formed between these surfaces. The first flow path 11 of the tube 10 communicates with the first hole 21 (port 22). The second flow path 12 (see FIG. 2) of the tube 10 communicates with the first connecting flow path 38 (see FIG. 3E) opened in the stop surface 26.

The main body 20 is integrally provided with a lid 29 via a hinge 28. The lid 29 is rotatable around the hinge 28. 1A-3E show the lid 29 in the open state. Although not shown, the lid 29 is superposed on the upper surface of the main body 20 in the closed state. The port 22 is covered with a lid 29. A locking convex portion 29a is provided on the end edge of the lid 29 opposite to the hinge 28 so that the lid 29 is maintained in the closed state, and the main body 20 has a locking concave portion 20a into which the locking convex portion 29a is fitted. It is provided. The structure for keeping the lid 29 in the closed state is not limited to the locking convex portion 29a and the locking concave portion 20a, and can be arbitrarily changed. The outer surface of the lid 29 (the surface facing the opposite side of the port 22 in the closed state) is a smooth convex curved surface. When the lid 29 is closed, the convex curved surface of the lid 29 is continuous with the outer surface of the main body 20 to form a smooth convex curved surface as a whole. Therefore, the patient does not feel a sense of discomfort in the main body 20 with the lid 29 closed, and the possibility that the main body 20 is caught in clothing is low.

The main body 20 is provided with a second hole 30 extending along the horizontal direction. As shown in FIG. 3D, the second hole 30 is a non-through hole (so-called blind hole) in which one end in the longitudinal direction thereof is open and the other end is closed. The opening of the second hole 30 is provided on the side surface of the main body 20 (the side surface along the long side of the main body 20 having a substantially rectangular shape in a plan view). The second hole 30 is provided at a position slightly distant from the first hole 21 on the side opposite to the hinge 28. The central axis of the second hole 30 is perpendicular to the straight line (radius of the first hole 21) extending from the central axis of the first hole 21. The second hole 30 includes a large diameter portion 31 and a cylindrical portion 32. The inner peripheral surfaces of the large diameter portion 31 and the cylindrical portion 32 are both cylindrical surfaces whose inner diameters are constant in the longitudinal direction of the second hole 30. The large diameter portion 31 extends from the open end edge of the second hole 30 and has the largest inner diameter in the second hole 30. Two tapered portions 33 are provided between the large diameter portion 31 and the cylindrical portion 32 so that the inner diameter increases toward the large diameter portion 31. A stop protrusion 34 is provided at the deepest portion of the second hole 30. The stop protrusion 34 is a protrusion whose shape as seen along the longitudinal direction of the second hole 30 is substantially triangular (see FIG. 3C).

The main body 20 is further provided with a first connecting flow path 38 and a second connecting flow path 39. The first and second connecting flow paths 38 and 39 have a smaller diameter than the second hole 30 and extend straight. The first connecting flow path 38 connects the cylindrical portion 32 of the second hole and the stop surface 26 (see FIGS. 3C to 3E). The second connecting flow path 39 connects the cylindrical portion 32 of the second hole and the first hole 21 (particularly the large diameter portion 21a) (see FIGS. 3B to 3D). The opening 39a of the second connecting flow path 39 on the inner peripheral surface of the first hole 21 is located below the one-way valve 23 (on the tube 10 side) (see FIG. 1B). As shown in FIG. 3C, the second connecting flow path 39 is higher on the first hole 21 (opening 39a) side than on the hole 30 (cylindrical portion 32) side when viewed along the horizontal direction. It is tilted. That is, the opening 39a of the second connecting flow path 39 faces diagonally upward toward the one-way valve 23. Further, as shown in FIG. 3D, when viewed along the central axis of the first hole 21, the opening 39a of the second connecting flow path 39 faces a direction deviating from the central axis of the first hole 21. ing. That is, the second connecting flow path 39 extends along the tangent line of the inner peripheral surface of the first hole 21 (particularly the large diameter portion 21a).

The material of the body 20 (including the hinge 28 and the lid 29) is preferably flexible and biocompatible, but is not limited, such as silicone rubber, because the body 20 is indwelled on the patient's body surface for a long period of time. Polyurethane elastomers can be used, with silicone rubber being particularly preferred.

The material of the cap 24 is preferably a hard material (hard material) having mechanical strength (rigidity) to such an extent that it is not substantially deformed by an external force. Use, but not limited to, resin materials such as polycarbonate (PC), acrylonitrile-butadiene-styrene copolymer (ABS), hard polyvinyl chloride, polyacetal (POM), polystyrene, polyamide, polyethylene, polypropylene (PP). Of these, polycarbonate, acrylonitrile-butadiene-styrene copolymer, and polypropylene are preferable.

4A is a perspective view of the cock 40, and FIG. 4B is a sectional view of the cock 40. As shown in FIG. 4A, the cock 40 has a substantially cylindrical shape as a whole. A base end portion 41 and a cylindrical portion 42 are provided on the outer peripheral surface of the cock 40. The outer peripheral surfaces of the base end portion 41 and the cylindrical portion 42 are both cylindrical surfaces whose outer diameters are constant in the longitudinal direction of the cock 40. The base end portion 41 has a larger outer diameter than the cylindrical portion 42. Two tapered portions 43 whose outer diameter is changed toward the proximal end portion 41 are provided between the proximal end portion 41 and the cylindrical portion 42. A stop protrusion 44 is provided at the tip of the cock 40. The stop protrusion 44 is a protrusion whose shape as seen along the longitudinal direction of the cock 40 is substantially triangular.

As shown in FIG. 4B, the cock 40 is provided with a hole 45 extending from the side end of the base end portion 41 along the longitudinal direction of the cock 40. The hole 45 is a non-penetrating hole (so-called blind hole) that does not penetrate the cock 40 in the longitudinal direction and is opened only on the base end portion 41 side. A female tapered surface 46 is provided on the inner peripheral surface of the hole 45 in a region (a region corresponding to the proximal end portion 41) at a predetermined distance from the opening edge of the hole 45. The female tapered surface 46 is a tapered surface (or conical surface) whose inner diameter increases toward the opening. The female tapered surface 46 is coaxial with the central axis of the cock 40 (that is, the rotation axis of the cock 40). The female tapered surface 46 functions as a female connector.

The columnar portion 42 is provided with two lateral holes 48, 49 extending in the radial direction. The lateral holes 48 and 49 communicate the lumen of the hole 45 with the outside world of the cock 40 in the radial direction.

The cock 40 is fitted into the second hole 30 of the main body 20. The base end portion 41, the tapered portion 43, and the cylindrical portion 42 of the cock 40 are fitted to the large diameter portion 31, the tapered portion 33, and the cylindrical portion 32 of the second hole 30, respectively. Once the tapered portion 43 and the tapered portion 31 are fitted, it is difficult to pull out the cock 40 from the second hole 30. The outer peripheral surface of the cylindrical portion 42 and the outer peripheral surface of the cylindrical portion 32 are in surface contact with each other, and a liquidtight seal is formed between them.

The cock 40 is rotatable about its central axis in the second hole 30. However, since the stop protrusion 44 of the cock 40 collides with the stop protrusion 34 of the second hole 30, the rotatable angle range of the cock 40 in the second hole 30 is limited to a predetermined angle (about 180 degrees in this embodiment). Will be done. The stop protrusions 34 and 44 function as a "rotatable angle limiting mechanism" that limits the rotatable angle range of the cock 40.

When the cock 40 is in a rotation direction position, the first lateral hole 48 of the cock 40 communicates with the first connecting flow path 38 of the main body 20. As a result, the hole 45 of the cock 40 is communicated with the balloon 15 via the first lateral hole 48, the first connecting flow path 38, and the second flow path 12 of the tube 10 in this order. The second lateral hole 49 of the cock 40 is liquidtightly sealed by the inner peripheral surface of the cylindrical portion 32 of the second hole 30. Further, the second connecting flow path 39 of the main body 20 is liquidtightly sealed by the outer peripheral surface of the cylindrical portion 42 of the cock 40. In the present embodiment, this rotation direction position of the cock 40 is referred to as a "second position".

When the cock 40 is in another rotational position, the second lateral hole 49 of the cock 40 communicates with the second connecting flow path 39 of the main body 20. As a result, the hole 45 of the cock 40 is communicated with the first hole 21 via the second horizontal hole 49 and the second connecting flow path 39 in this order. The first lateral hole 48 of the cock 40 is liquidtightly sealed by the inner peripheral surface of the cylindrical portion 32 of the second hole 30. Further, the first connecting flow path 38 of the main body 20 is liquidtightly sealed by the outer peripheral surface of the cylindrical portion 42 of the cock 40. In the present embodiment, this rotation direction position of the cock 40 is referred to as a "third position".

When the cock 40 is in a position other than the above-mentioned second and third positions, the first and second lateral holes 48 and 49 of the cock 40 are liquid-tightened by the inner peripheral surface of the cylindrical portion 32 of the second hole 30. The first and second connecting flow paths 38 and 39 of the main body 20 are hermetically sealed by the outer peripheral surface of the cylindrical portion 42 of the cock 40. In the present embodiment, this rotation direction position of the cock 40 is referred to as a "first position".

A tapered surface 46 that functions as a female connector is formed on the inner peripheral surface of the hole 45 of the cock 40. Therefore, the female connector provided on the cock 40 communicates with the balloon 15 when the cock 40 is in the second position, communicates with the first hole 21 when the cock 40 is in the third position, and the cock 40 is in the first position. When it is in, it is sealed without communicating with either the balloon 15 or the first hole 21. Further, the balloon 15 communicates with the female connector when the cock 40 is in the second position, and the communication with the outside world is cut off when the cock 40 is in the first position and the third position. Further, the first hole 21 communicates with the female connector when the cock 40 is in the third position and does not communicate with the female connector when the cock 40 is in the first and second positions. In this way, the cock 40 functions as a "switching valve" that switches the communication state between the female connector, the balloon 15, and the first hole 21.

The material of the cock 40 is preferably a hard material (hard material) having mechanical strength (rigidity) to such an extent that it is not substantially deformed by an external force. Use of, but not limited to, resin materials such as polycarbonate (PC), acrylonitrile-butadiene-styrene copolymer (ABS), rigid polyvinyl chloride, polyacetal (POM), polystyrene, polyamide, polyethylene, polypropylene (PP). Of these, polycarbonate and polypropylene are preferable.

A method of using the catheter 1 of the present embodiment will be described.

In normal use of the catheter 1 in which the catheter 1 is placed in the patient, the balloon 15 is inflated in the stomach and the cock 40 is set in the first position. Since the communication between the balloon 15 and the outside world is cut off, the inflated state of the balloon 15 is maintained. Since the communication between the first hole 21 and the female connector is cut off, even if the contents of the stomach flow back into the first hole 21 through the first flow path 11 of the tube 10, the contents leak from the cock 40 to the outside world. It never comes out. In this normal use state, the port 22 is covered with a lid 29 in order to maintain good hygiene. Further, in order to maintain good hygiene of the hole 45 of the cock 40, the opening of the hole 45 may be closed by inserting a stopper (not shown) into the female tapered surface 46.

A method of contracting or inflating the balloon 15 will be described. First, the tip 72 of the tip of the outer cylinder 71 of the syringe 70 is inserted into the female tapered surface 46 (see FIG. 4B) of the cock 40 (see FIG. 1A). Water for inflating the balloon 15 (for example, distilled water) may be stored in the syringe 70. FIG. 5 is a cross-sectional view showing a state in which the cylinder tip 72 is inserted into the female tapered surface 46. The outer peripheral surface of the cylinder tip 72 is provided with a male tapered surface whose outer diameter decreases toward the tip of the cylinder tip 72. The female tapered surface 46 of the cock 40 is configured to have the same diameter and taper angle as the male tapered surface of the cylinder tip 72. For example, the female tapered surface 46 and the male tapered surface may be 6% tapered surfaces conforming to ISO594-1. Therefore, the female tapered surface 46 of the cock 40 and the male tapered surface of the cylinder tip 72 are in surface contact with each other to form a so-called taper fitting (sometimes called a slip connection) and are liquidtightly connected.

With the cylinder tip 72 connected to the cock 40, the syringe 70 (particularly its outer cylinder 71) is rotated. Since a frictional force is generated between the female tapered surface 46 and the male tapered surface, when the syringe 70 is rotated, the cock 40 rotates integrally with the syringe 70. Rotate the cock 40 to the second position. The balloon 15 is communicated with the syringe 70. In this state, the plunger 73 (see FIG. 1A) of the syringe 70 is operated to suck the water in the balloon 15 into the balloon 70 to contract the balloon 15, or inject the water in the syringe 70 into the balloon 15. Inflate the balloon 15. The syringe 70 is then rotated to return the cock 40 to the first position. After that, the cylinder tip 72 is pulled out from the cock 40. The inflated or deflated state of the balloon 15 is maintained.

In the above operation of expanding and contracting the balloon 15, the cock 40 can only be switched in the order of the first position, the second position, and the first position, and cannot be switched to the third position. Therefore, water for inflating the balloon 15 does not pass through the first hole 21 and flow into the stomach by this operation.

A method of administering a nutritional supplement to a patient via the catheter 1 will be described. First, the lid 29 is opened to expose the port 22. Next, in FIG. 1A, the male luer 61 at the tip of the male connector 60 is inserted into the port 22. In this state, the nutritional supplement is flushed toward the patient. The nutritional supplement flows into the stomach through the male connector 60, the one-way valve 23, the first hole 21, and the first flow path 11 of the tube 10 in this order. When the administration of the nutritional supplement is completed, the port 22 is covered with the lid 29. Since the one-way valve 23 is provided, nutrients and stomach contents do not leak from the port 22 to the outside world. While administering the nutrient, the cock 40 is maintained in the first position described above. Therefore, the administered nutritional supplement in the first hole 21 does not leak from the cock 40 to the outside world.

After administering the nutrient, the tip 72 of the syringe 70 may be connected to the cock 40 (see FIG. 5). For example, water (or plain hot water) is stored in the syringe 70. Rotate the syringe 70 to switch the cock 40 to the third position. The syringe 70 communicates with the first hole 21. In this state, push the plunger 73. The water in the syringe 70 is vigorously ejected into the first hole 21 from the second connecting flow path 39 (see FIG. 1B). The nutrients adhering to the lower surface of the one-way valve 23 (the surface on the tube 10 side), the inner peripheral surface of the first hole 21, and the inner peripheral surface of the first flow path 11 of the catheter 10 are washed away with water to the patient. Sent to the stomach. The syringe 70 is then rotated to return the cock 40 to the first position. After that, the cylinder tip 72 is pulled out from the cock 40.

In the jet of water from the second connecting flow path 39 to the first hole 21, the contents regurgitated from the stomach (hereinafter referred to as “stomach contents”) are the lower surface of the one-way valve 23 and the inner circumference of the first hole 21. It is also effective for washing away the stomach contents when it adheres to the surface and the inner peripheral surface of the first flow path 11.

In the above operation of cleaning the flow path of the nutrient, the cock 40 can only be switched in the order of the first position, the third position, and the first position, and cannot be switched to the second position. Therefore, this operation does not cause the water in the balloon 15 to accidentally flow out to the female connector and cause the balloon 15 to contract.

As described above, the catheter 1 of the present embodiment is a cock capable of switching the rotation direction position between the first position for blocking communication between the balloon 15 and the outside world and the second position for communicating the balloon 15 with the female connector. 40 is provided. Therefore, in the present embodiment, it is not necessary to provide a one-way valve in the flow path communicating with the balloon 15.

As described above, in the conventional catheter, in order to drain the water in the balloon, it is necessary to open a one-way valve (hereinafter referred to as "one-way valve for balloon") provided in the flow path communicating with the balloon. rice field. If the one-way valve is of the Duckville type, a special device is required to open the one-way valve. On the other hand, in the present embodiment, the balloon 15 can be communicated with the female connector without using a dedicated instrument. The operation of draining the water in the balloon 15 is extremely simple.

Further, the cock 40 can also switch its rotation direction position to a third position in which the female connector communicates with the first hole 21. When water is injected from the female connector while the cock 40 is in the third position, the water is ejected into the first hole 21, and the lower surface of the one-way valve 23, the inner peripheral surface of the first hole 21, and the first hole 21 are injected. The nutrients and stomach contents adhering to the inner peripheral surface of the flow path 11 are washed away. If nutrients and stomach contents remain attached to these surfaces, they are prone to unsanitary conditions such as bacterial growth. The catheter 1 of the present embodiment can always maintain a clean flow path of the nutrient preparation.

Unlike the present embodiment, if a dedicated female connector for connecting a syringe storing water for cleaning is provided in the main body 20 separately from the cock 40, the flow path of the nutrient is washed with the water. Is possible. However, in this configuration, the main body 20 becomes large by providing a dedicated female connector. In this embodiment, the female connector provided on the cock 40 is used for both expansion and contraction of the balloon 15 and cleaning of the nutrient flow path. This configuration makes it possible to add a function of cleaning the flow path of the nutrient to the balloon-shaped catheter 1 without enlarging the main body 20.

The opening 39a of the second connecting flow path 39 has an inclination angle with respect to the horizontal surface (that is, an inclination with respect to the one-way valve 23) and a vertical direction so that water is ejected from the opening 39a toward the one-way valve 23. The position (that is, the distance to the one-way valve 23) and the like are set. Dirt tends to adhere to the lower surface of the one-way valve 23 for a long period of time, and therefore, it is easy to fall into an unsanitary state. By injecting water toward the lower surface of the one-way valve 23, the lower surface of the one-way valve 23, which is particularly liable to get dirty, can be maintained in a clean state.

Further, when the water jetted from the opening 39a is viewed along the central axis of the first hole 21 so as to swirl and flow along the inner peripheral surface of the first hole 21 (particularly the large diameter portion 21a). The orientation of the opening 39a of the two connecting flow paths 39 is set. As a result, water can be flowed over a wider range, so that the amount of unwashed nutrients and stomach contents is reduced, and the flow path of the nutrients can be maintained in a clean state.

A female connector is provided on the cock 40. This is advantageous in reducing the size of the main body 20 as compared with the case where the female connector is provided separately from the cock 40.

The female connector includes a female tapered surface 46 coaxial with the rotation axis of the cock 40. Therefore, the female tapered surface 46 of the female connector can be tapered and fitted with the male tapered surface widely used for the cylinder tip 72 of the syringe 70. Tapered fitting makes it easy to connect and separate the female connector and the male connector (cylinder tip 72), and in the connected state, a liquid-tight seal is formed between the female connector and the male connector, and a rotational force is further applied between the two connectors. It can also be communicated. Therefore, the syringe 70 used for injecting or sucking water into the balloon 15 or injecting water into the first hole 21 can also be used to rotate the cock 40. A series of operations necessary for inflating and contracting the balloon 15 and cleaning the flow path of the nutrient preparation can be efficiently performed using only the syringe 70 without using a special instrument.

Further, since the rotational force can be transmitted only by inserting the cylinder tip 72 of the syringe 70 into the female connector of the cock 40, for example, an engaging structure that engages with each other is provided between the cock 40 and the cylinder tip 72. There is no need. Therefore, the cock 40 can be miniaturized. Further, the engagement structure provided on the cock 40 does not cause a malfunction in which the patient's clothing is caught and the cock 40 unintentionally rotates.

The axis of rotation of the cock 40 is parallel to a plane (that is, a horizontal plane) perpendicular to the central axis of the first hole 21. When viewed along the central axis of the first hole 21, the rotation axis of the cock 40 is perpendicular to a straight line extending from the central axis of the first hole 21 (that is, a straight line along the radial direction of the first hole 21). Is. In other words, when viewed along the central axis of the first hole 21, the axis of rotation of the cock 40 is located outside the first hole 21 and parallel to the circular tangent of the first hole 21. .. Such an arrangement of the cock 40 with respect to the main body 20 reduces the horizontal dimension of the main body 20 and is advantageous for miniaturization of the main body 20. In contrast, in conventional catheters, the one-way valve for balloons is arranged so that its central axis coincides with a straight line (a straight line along the radial direction) extending from the central axis of the flow path through which the nutrients flow. Was common (see, for example, Patent Document 1). Therefore, the main body of the catheter installed on the body surface has an elongated shape with the straight line as the long axis. Such an elongated and large body installed on the surface of the body makes the patient feel uncomfortable. In the present embodiment, the cock 40 can be arranged as described above by providing the first and second connecting flow paths 38 and 39 substantially perpendicular to the longitudinal direction of the cock 40. The plan view shape of the main body 20 of the present embodiment (shape seen along the central axis of the first hole 21, see FIG. 3D) has an aspect ratio (major axis direction dimension / minor axis direction dimension) as compared with the conventional main body. ) Is small and is closer to a square or circle as a whole. The patient is less likely to feel discomfort with the main body 20.

The above embodiment is merely an example. The present invention is not limited to the above embodiment, and can be appropriately modified.

In the above embodiment, the opening 39a of the second connecting flow path 39 is configured such that the water jetted from the opening 39a swirls toward the one-way valve 23 and on the inner peripheral surface of the large diameter portion 21a. Was done. However, the direction of the water jetted from the opening 39a is not limited to this, and can be arbitrarily changed. Further, two or more openings 39a into which water is injected may be provided by providing two or more second connecting flow paths 39 or by branching the second connecting flow path 39. In this case, water is sprayed from different directions toward the one-way valve 23, or the one-way valve 23 and the inner peripheral surface of the first hole 21 (or the large diameter portion 21a) are sprayed from different openings 39a. It can be washed, etc., and the cleanability of the flow path of the nutritional supplement is improved.

In the present invention, it is also possible to configure the cock 40 so that it cannot rotate to the third position. In this case, the cock 40 can be switched only to the first position and the second position.

The arrangement of the cock 40 in the main body 20 is not limited to the above embodiment, and may be arbitrarily changed. For example, the rotation axis of the cock 40 may be along the radial direction of the first hole 21.

The configuration of the rotatable angle limiting mechanism of the cock 40 is not limited to the stop protrusions 34 and 44. For example, the rotatable angle limiting mechanism may be provided on the outer peripheral surface of the cock 40 (for example, the base end portion 41) and the inner peripheral surface of the second hole 30 corresponding to the outer peripheral surface.

The rotatable angle range of the cock 40 can be set arbitrarily. The first position, the second position, and the third position can be provided at any position within this range. For example, one of the two rotation limit positions that define the rotatable angle range of the cock 40 may be the second position, the other may be the third position, and the space between them may be the first position. According to this configuration, the alignment of the first and second lateral holes 48, 49 with respect to the first and second connecting flow paths 38, 39 becomes easy. Further, when the cock 40 is switched from the first position (the position when the catheter 1 is normally used) to the third position where the flow path of the nutrient is washed, the cock 40 does not pass through the second position, so that the cock 40 does not pass through the second position. It is possible to prevent an erroneous operation in which water unintentionally leaks from the female connector.

In the present invention, the cock 40 may be configured to be freely rotatable by omitting the rotatable angle limiting mechanism (stop projections 34, 44) of the cock 40.

The one-way valve 23 provided in the first hole 21 is not limited to the duck bill type, and any one-way valve can be used.

The field of application of the present invention is not limited, but it can be widely used as a balloon-type gastric fistula catheter placed in a gastric fistula. In particular, the tube inserted into the gastric fistula can be used as a balloon button type gastric fistula catheter that is fixed by a balloon in the stomach and a main body on the body surface.

1 Gastric fistula catheter (catheter)
10 Tube 11 1st flow path 12 2nd flow path 15 Balloon 20 Main body 21 1st hole 23 One-way valve 34 Stop protrusion (rotatable angle limiting mechanism)
38 1st connecting flow path 39 2nd connecting flow path 39a Opening on the 1st hole side of the 2nd connecting flow path 40 Cock 44 Stop protrusion (rotatable angle limiting mechanism)
46 Female tapered surface (female connector)

Claims (9)

A flexible tube provided with a first flow path and a second flow path,
An inflatable and contractible balloon provided at the tip of the tube and communicating with the second flow path,
A balloon-type gastric fistula catheter with a body connected to the base end of the tube.
The main body is
A first hole that penetrates the main body and communicates with the first flow path of the tube,
The one-way valve provided in the first hole and
Equipped with a rotatable cock with a female connector,
The rotation direction position of the cock is a first position where the cock blocks communication between the balloon and the outside world, a second position where the balloon is communicated with the female connector via the second flow path, and the female. A balloon-type gastric fistula catheter characterized in that the connector can be switched to a third position that communicates with a portion on the first flow path side of the one-way valve of the first hole. The first aspect of the present invention, wherein the opening on the first hole side of the flow path for communicating the female connector and the first hole is configured so that the liquid is ejected from the opening toward the one-way valve. Balloon type gastric fistula catheter. The opening on the first hole side of the flow path that communicates the female connector and the first hole is configured so that the liquid jetted from the opening swirls on the inner peripheral surface of the first hole and flows. The balloon-type gastric fistula catheter according to claim 1 or 2. The balloon-type gastric fistula catheter according to any one of claims 1 to 3, wherein communication between the balloon and the outside world is cut off when the cock is in the third position. Any of claims 1 to 4, when viewed along the central axis of the first hole, the axis of rotation of the cock does not intersect the central axis and is perpendicular to a straight line extending from the central axis. The balloon-type gastric fistula catheter according to paragraph 1. A flexible tube provided with a first flow path and a second flow path,
An inflatable and contractible balloon provided at the tip of the tube and communicating with the second flow path,
A balloon-type gastric fistula catheter with a body connected to the base end of the tube.
The main body is
A first hole that penetrates the main body and communicates with the first flow path of the tube,
The one-way valve provided in the first hole and
Equipped with a rotatable cock with a female connector,
The rotation direction position of the cock is switched between a first position where the cock blocks communication between the balloon and the outside world and a second position where the balloon communicates with the female connector via the second flow path. Can be done,
When viewed along the central axis of the first hole, the rotation axis of the cock does not intersect the central axis and is perpendicular to a straight line extending from the central axis. Deaf catheter. The balloon-type stomach according to any one of claims 1 to 6, wherein when the cock is in the first position and the second position, the cock blocks communication between the first hole and the female connector. Deaf catheter. The female connector comprises a female tapered surface coaxial with the axis of rotation of the cock.
The balloon-type gastric fistula catheter according to any one of claims 1 to 7, wherein the female tapered surface is a tapered surface whose inner diameter increases toward its opening. The balloon-type gastric fistula catheter according to any one of claims 1 to 8, further comprising a rotatable angle limiting mechanism for limiting the rotatable angle range of the cock.

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