JP2021154089A - Transfistula tube device - Google Patents

Abstract

To provide a transfistula tube device simplifying management in an acute period, while mitigating stimulation to a wound area in a fistula after the construction and preventing leak of transudate.SOLUTION: A transfistula tube device 100 comprises a lumen 21 for passing fluid from a distal side to a proximal side, and a tube 20 to be inserted into a fistula constructed, with it penetrating through an abdominal wall and a gastric tube wall (a gastric wall), which is an alimentary tract, of a patient. The tube 20 includes an absorbing expansion part 40 provided such that at least a part thereof is located in the fistula H and expanding by absorbing transudate leaked from the fistula.SELECTED DRAWING: Figure 1

Description

The present invention relates to a transfistula tube device that supplies fluid into the gastrointestinal tract from a constructed fistula.

Conventionally, as a response to patients who have difficulty in adequate nutritional management by oral ingestion due to swallowing disorders, various fluids such as nutritional supplements, liquid foods, and drugs are directly applied to the digestive tract (stomach, jejunum, etc.) from outside the body. The tube feeding method to be delivered is selected. In tube feeding, for example, a fistula (gastrostomy) that serves as a passage for fluid between the inside of the stomach and the body surface is constructed by percutaneous endoscopic gastrostomy (PEG), and the stomach is constructed. The fluid is supplied directly into the stomach via a dedicated tube device that is attached to the fistula.

Patent Document 1 below discloses a gastrostomy tube device attached to a fistula constructed by PEG. The device of Patent Document 1 is a tubular tube (shaft) that is inserted into a fistula to supply fluid into the stomach, and an internal body that is provided on the tip side of the tube to prevent the device from coming off the patient. Locking part for fixing (internal balloon) and connecting part for fixing outside the body (main body including nutrient injection port and external balloon) that is connected to the tube to supply a predetermined fluid and is locked outside the body It has.

Japanese Unexamined Patent Publication No. 2003-38655

Generally, after PEG construction, about 1 to 2 weeks until the fistula is completed is the acute phase, and various body fluids such as bleeding, exudate, and gastric fluid from the created wound (hereinafter, these fluids are "leaked". (Refered to "fluid") leaks easily, and there is a high risk of causing complications such as wound infection, local compression necrosis, peri-fistula dermatitis, and thus peritonitis and septicemia due to pressure on the stomach wall or wound by a gastrostomy. .. Therefore, in the acute phase, it is necessary to remove the contamination between the fistula and the tube with gauze or the like while observing the skin condition of the patient to keep the wound portion clean.

Further, in order to prevent fistula ulcers and adhesions, the tube is rotated and moved at least once a day, but friction due to excessive movement of the tube, foreign body reaction by the tube, and the like can cause defective granulation.

As described above, in the acute phase after fistula construction, the medical staff has different care methods depending on the condition of the patient and the condition of the wound, so it is necessary to manage it while paying close attention according to the situation. The burden is heavy.

At least one embodiment of the present invention has been made in view of the above circumstances, and specifically, it is acute while alleviating irritation to the wound portion in the fistula after construction and preventing leakage of leaked liquid. It is an object of the present invention to provide a transfistula tube device that can simplify the management in the period.

The transfistula tube device according to the present embodiment includes a lumen that communicates from the distal end side to the proximal end side, and inserts a tube that is inserted into the fistula that is constructed through the abdominal wall of the patient and the tube wall of the gastrointestinal tract. The tube is provided with an absorption-expanding portion that is provided so that at least a part thereof is located in the fistula and absorbs and expands the leaked liquid leaking from the fistula.

According to at least one embodiment of the present invention, it is possible to simplify the management in the acute phase while alleviating the irritation to the wound portion in the fistula after construction and preventing the leakage of the leaked liquid.

It is a figure which shows the schematic structure of the transfistula tube device which concerns on this embodiment. It is a figure which shows the state which the transfistula tube device which concerns on this embodiment is attached to a patient. It is a perspective view which shows typically the absorption expansion part which concerns on this embodiment. It is sectional drawing of the absorption expansion part cut by the line BB shown in FIG. It is a figure which shows the state at the time of use of the transfistula tube which concerns on this embodiment. It is a figure which shows the state at the time of use of the transfistula tube which concerns on this embodiment. It is a figure which shows the state at the time of use of the transfistula tube which concerns on this embodiment. It is a figure which shows the state at the time of use of the transfistula tube which concerns on this embodiment. It is a figure which shows the state at the time of use of the transfistula tube which concerns on this embodiment. It is a figure which shows the modification of the transfistula tube which concerns on this embodiment.

Hereinafter, embodiments for carrying out the present invention will be described in detail with reference to the drawings. The embodiments shown here are examples for embodying the technical idea of the present invention, and do not limit the present invention. In addition, all other feasible forms, examples, operational techniques, etc. that can be considered by those skilled in the art without departing from the gist of the present invention are included in the scope and gist of the present invention, and are described in the claims. It is included in the invention and its equivalent range.

Further, the drawings attached to the present specification may be represented schematically by changing the scale, aspect ratio, shape, etc. from the actual ones for convenience of illustration and comprehension. However, it does not limit the interpretation of the present invention.

In the present specification, the side to be inserted into the living body is referred to as "tip" or "tip side", and the hand side operated by the operator is referred to as "base end" or "base end side". Further, a portion indicating a certain range including the tip and its peripheral portion is referred to as a "tip portion", and a portion indicating a certain range including the proximal end and its peripheral portion is referred to as a "base end portion". Further, the direction in which the tube 20 extends is referred to as an "axial direction", and the direction orthogonal to the axial direction is referred to as a "width direction". For example, the "short direction X" in FIG. 3 corresponds to the width direction, and the "longitudinal direction Y" corresponds to the axial direction. These directions are set for convenience to explain the relative relationships of the components.

The transfistula tube device 100 according to the present embodiment has a gastrointestinal tract D (stomach, It is a device for directly supplying the fluid F to the intestine (jejunum, etc.). The transfistula tube device 100 according to the present embodiment will be described as a so-called "gastrostomy tube device" installed in a gastric fistula constructed in the stomach as a fistula H.

Further, as the transfistula tube device 100 according to the present embodiment, the device configuration of a general fistula tube device (gastrostomy tube or the like) installed in the fistula H constructed in the patient can be applied. In the present embodiment, a so-called "balloon button type" is adopted in which the internal locking portion 10 is a "balloon type" and the external locking portion 30 is a "button type" as the device configuration.

The transfistula tube device 100 is not limited to the "balloon button type" as a device configuration, and the "balloon tube" in which the internal locking portion 10 is "balloon type" and the external locking portion 30 is "tube type". "Mold", "bumper button type" with the internal locking part 10 as the "bumper type" and the external locking part 30 as the "button type", and the internal locking part 10 as the "bumper type" with the external locking part 30 It can also be applied to the "bumper tube type" which is the "tube type". The device configuration of the transfistula tube device 100 may be appropriately selected in consideration of the pathological condition of the patient, the patient response status of a hospital or a nursing care facility, and the like.

The fistula H to which the transfistula tube device 100 according to the present embodiment is mounted is a hole created to directly supply the fluid F into the gastrointestinal tract D of the patient. The fistula H may be constructed by, for example, percutaneous endoscopic gastrostomy (PEG) or percutaneous endoscopic jejunostomy (PEJ). The fistula H may be constructed by a method other than these construction techniques.

In the transfistula tube device 100 according to the present embodiment, the "fluid F" supplied to the digestive tract D is, for example, a fluid generally used in tube feeding methods such as nutritional supplements, liquid foods, and drugs. Aspects thereof include solidified, semi-solidified, gelled or solified, and mixtures thereof.

[composition]
FIG. 1 shows the configuration of the transfistula tube device 100 according to the present embodiment, and FIG. 2 shows a state in which the transfistula tube device 100 is installed in a patient. As shown in FIG. 1 or 2, the transfistula tube device 100 includes an internal locking portion 10, a tube 20, an external locking portion 30, and an absorption and expansion portion 40. In the transfistula tube device 100, the internal locking portion 10 and the external locking portion 30 function as a detachment prevention device for preventing the patient from coming off, and are attached through the fistula H of the patient.

In the present embodiment, the transfistula tube device 100 will be described with a configuration in which the internal locking portion 10 and the external locking portion 30 are integrally provided with respect to the tube 20, but these configurations are integrally formed. The form is not limited, and each may be a separate body and may be assembled and used at the time of use.

Further, as shown in FIG. 2, the transfistula tube device 100 is configured to be connected to the supply port 32 of the extracorporeal locking portion 30 with a connector 210 provided on the tip end side of the extracorporeal tube 200. The base end side of the extracorporeal tube 200 is connected to the outlet 310 of the container 300 accommodating the fluid F, and the fluid F is supplied into the body via the extracorporeal tube 200.

As shown in FIG. 2, the fluid F is flowed downward from the container 300 arranged at the upper part in the figure. The axial directions of the inner body flow path 11, the lumen 21, and the outer body flow path 33 substantially coincide with the flow direction of the fluid F (for example, the vertical direction in FIG. 2).

<Internal locking part>
As shown in FIG. 1, the internal locking portion 10 is composed of a bag-shaped annular member that is displaced by injecting a predetermined fluid so as to be expandable and contractible. Functions as a stop.

As shown in FIG. 1, the internal locking portion 10 is in a contracted state when inserted into the body, and is expanded in a ring shape when a fluid is injected after being placed in the tube. Further, when the transfistula tube device 100 is replaced, the fluid to be filled can be removed and the transfistula tube device 100 can be removed from the fistula H in a reduced state. The internal locking portion 10 may be composed of a balloon that expands by being filled with a predetermined fluid (distilled water, physiological saline, etc. if it is a liquid, air, oxygen, etc. if it is a substrate).

The internal locking portion 10 is expanded in the gastrointestinal tract D in order to prevent the transfistula tube device 100 from detaching from the fistula H, and is placed in the gastrointestinal tract D in a state of being in contact with the tube wall Dw of the gastrointestinal tract D. Will be done. This prevents the transfistula tube device 100 from being detached due to accidental removal or the like.

Further, a body inner flow path 11 communicating with the lumen 21 of the tube 20 is provided at a substantially central portion of the body locking portion 10. The fluid F supplied from the container 300 passes through the extracorporeal tube 200 and the lumen 21 of the tube 20, and is supplied into the digestive tract D via the internal flow path 11 of the internal locking portion 10.

The constituent material of the internal locking portion 10 is preferably a soft material having flexibility and biocompatibility that can be expanded and contracted by a fluid and can be used in the medical field, and is not particularly limited, but as an example, a silicone rubber or an elastomer material. Etc. can be preferably used.

<tube>
The tube 20 is a tubular member that is interposed between the base end side of the internal locking portion 10 and the bottom of the main body 31 of the external locking portion 30 and extends along the flow direction of the fluid F. The tube 20 has a lumen 21 that communicates from the distal end side to the proximal end side along the axial direction. The distal end side of the lumen 21 communicates with the inner body flow path 11 of the internal locking portion 10, and the proximal end side communicates with the outer body flow path 33 of the main body 31 of the extracorporeal locking portion 30.

The constituent material of the tube 20 is preferably a soft material having flexibility and biocompatibility that can be used in the medical field, and is not particularly limited, but as an example, a silicone rubber, an elastomer material, or the like may be preferably used. can. Further, the tube 20 can be configured by using the same material as the internal locking portion 10.

The total length of the tube 20 depends on the total length of the fistula H (that is, the length from the patient's body surface (the epidermis constituting the abdominal wall Aw covering the abdominal cavity) to the inner surface of the gastrointestinal tract D in the body). May be set. Further, the diameter of the tube 20 may be appropriately set so as to be compatible with the state of the flowing fluid F (viscosity, size of solid matter, etc.).

<External locking part>
The extracorporeal locking portion 30 is provided so that at least a part of the body surface (epidermis) is in contact with the base end side of the tube 20, functions as a retainer for the transfistula tube device 100, and is in contact with the extracorporeal tube 200. It also functions as an introduction unit that is connected and introduces the fluid F into the tube 20.

The extracorporeal locking portion 30 is via a main body 31, a supply port 32 provided on the upper surface of the main body 31, an outer body flow path 33 communicating from the opening of the supply port 32 toward the bottom of the main body 31, and a hinge 34. The lid portion 35 provided integrally is provided.

The main body 31 is, for example, a plate-shaped member having a predetermined thickness. A supply port 32 connected to the connector 210 of the extracorporeal tube 200 is provided on the upper surface of the main body 31. Further, a lid portion 35 is openably and closably connected to the edge portion of the upper surface of the main body 31 via a hinge 34.

The supply port 32 is provided on the upper surface of the main body 31 and is connected to the connector 210 of the extracorporeal tube 200. The opening of the supply port 32 is sealed by closing the lid portion 35. The supply port 32 is provided with an outer body flow path 33 communicating with the lumen 21 of the tube 20 inside the supply port 32. The body outer flow path 33 is provided so as to communicate with the opening of the supply port 32 toward the bottom of the main body 31, and allows the fluid F to flow through the tube 20.

The lid portion 35 is provided so as to be openably and closably connected to the main body 31 via a hinge 34. The lid portion 35 is provided with a top plate portion 35a, a side wall portion 35b provided so as to extend from the peripheral edge portion of the top plate portion 35a, and a bottomed cylindrical engaging recess 35c provided on the inner surface of the top plate portion 35a. Has been done. When the lid portion 35 is closed, the bottom portion of the engaging recess 35c is brought into close contact so as to cover the opening of the supply port 32, and the hermeticity of the transfistula tube device 100 is ensured in a state where the fluid F is not supplied. It has become like.

As a constituent material of the extracorporeal locking portion 30, the main body 31 is preferably a soft material that can be used in the medical field and has appropriate flexibility and biocompatibility because it is indwelled on the body surface of a patient for a long period of time. Although not particularly limited, a silicone rubber, an elastomer material, or the like can be preferably used as an example.

The constituent material of the supply port 32, the hinge 34, and the lid 35 is preferably a hard material (hard material) having a rigidity that is not substantially deformed by an external force applied at the time of opening and closing, and is not particularly limited. Resin materials such as polycarbonate, acrylonitrile-butadiene-styrene copolymer, rigid polyvinyl chloride, polyacetal, polyethylene, polystyrene, polyamide, and polypropylene can be preferably used. The extracorporeal locking portion 30 may be made of the same material as the entire component.

<Absorption expansion part>
In the absorption expansion portion 40, the absorption expansion portion 40 is provided between the internal locking portion 10 and the external locking portion 30 and at least above the proximal end side of the internal locking portion 10 to absorb the leaked liquid. And expand. As shown in FIG. 3, the absorption expansion portion 40 of the present embodiment is a rectangular sheet body, and is configured to be wound around the tube 20 and detachably attached to the tube 20.

The absorption expansion portion 40 is provided so that at least a part thereof is located inside the fistula H so that the leaked liquid leaked from the fistula H can be absorbed. However, considering the absorption efficiency of the leaked liquid, the stimulus-mitigating property of the tube 20 with respect to the fistula H, and the like, the absorption expansion portion 40 is provided on the surface of the tube 20 so as to cover the inner peripheral surface of the fistula H over the entire circumference. Is preferable. For example, in FIG. 3, the lateral direction of the absorption expansion portion 40 (longitudinal direction Y of the absorption expansion portion 40) is set to be substantially equal to the outer peripheral length of the tube 20, and the vertical direction of the absorption expansion portion 40 (absorption expansion portion 40). The dimension in the lateral direction X) may be set to be substantially equal to the total length of the tube 20.

The absorption expansion unit 40 absorbs the leaked liquid leaked from the fistula H and expands in the fistula H to prevent the leaked liquid from leaking from the fistula H. Further, the absorption expansion portion 40 serves as a cushioning material by expanding due to absorption of the leaked liquid, and suppresses irritation due to contact between the surface of the fistula H serving as the wound portion and the tube 20.

Subsequently, the configuration of the absorption / expansion portion 40 will be described in detail. As shown in FIG. 4, the absorption expansion portion 40 includes a support layer 41 as a substrate, an absorption expansion layer 42 provided on one surface of the support layer 41 (upper surface in FIG. 4), and the other surface of the support layer 41. An adhesive layer 43 provided on (lower surface in FIG. 4) and having an adhesive portion 43a and a support portion 43b is provided, and a plurality of functional layers (sheet bodies) are laminated. Further, the adhesive portion 43a of the absorption expansion layer 42 and the adhesive layer 43 is provided with a release liner 44 for preventing adhesion to other parts, absorption of liquid, etc. during storage.

The support layer 41 is a layer serving as a base of the absorption expansion portion 40 provided with the absorption expansion layer 42 on one surface (upper surface in FIG. 4) and the adhesive layer 43 on the other surface (lower surface in FIG. 4). be.

The constituent material of the support layer 41 is not particularly limited as long as it can form the absorbent expansion layer 42 and the adhesive layer 43 and has flexibility and biocompatibility and can be used in the medical field. For example, films, sheets, woven fabrics, non-woven fabrics and the like produced from polyesters such as polyethylene terephthalate, polyolefins such as polyethylene and polypropylene, rayon, nylon, cotton, urethane and pulp can be preferably used.

The absorption expansion layer 42 is a layer for absorbing and expanding the liquid leaked from the fistula H. The absorption expansion layer 42 is provided on one surface of the support layer 41 so as to be arranged so as to face the fistula H when the absorption expansion portion 40 is attached to the tube 20.

The constituent material of the absorption expansion layer 42 is not particularly limited as long as it is a material that is biocompatible and can be used in the medical field that can absorb and expand the leaked liquid, and is hydrophilic such as hydrogel. A polymer compound in which the compound is dispersed in the form of particles can be preferably used.

In addition, the polymer compound may contain the following additives, if necessary. Examples of such additives include preservatives, antibacterial agents, bactericides, antioxidants, and medicinal ingredients (for example, anti-inflammatory agents, vitamin agents, etc.). The sustained release rate of these additives can be appropriately adjusted according to a predetermined period (between the post-construction period and the acute phase, or between the chronic phase after the acute phase and the device replacement period).

Since the absorption expansion layer 42 has the same function as a commercially available hydrocolloid wound dressing, commercially available hydrocolloids such as Leucomed C (manufactured by Terumo Corporation) and Careleave (manufactured by Nichiban Co., Ltd.) It is also possible to apply a mold wound dressing.

The adhesive layer 43 is a layer for adhering to the surface of the tube 20 to adhere and hold the absorption / expansion portion 40 to the tube 20, and has an adhesive portion 43a and a support portion 43b on which the adhesive portion 43a is laminated. The adhesive layer 43 is provided on the other surface of the support layer 41 so that when the absorption expansion portion 40 is attached to the tube 20, it is arranged so as to face the surface of the tube 20.

The constituent material of the adhesive portion 43a is not particularly limited as long as it is a material that can be used in the medical field and has a biocompatible state in which the adhesive state with respect to the tube 20 is maintained at least in the acute phase in which the fistula H is formed. Copolymerized ester-based pressure-sensitive adhesives such as natural rubber-based, synthetic rubber-based, acrylic-based, silicone-based, and ethylene-vinyl acetate can be preferably used. Further, the constituent material of the support portion 43b is not particularly limited as long as the adhesive portion 43a can be supported, and for example, the same material as the support layer 41 can be used. The support layer 41 may provide the function of the support portion 43b.

The peeling liner 44 is laminated so as to be peelable from each layer in order to protect the absorption expansion layer 42 and the adhesive layer 43. The release liner 44 is peeled off when it is attached to the tube 20.

The constituent material of the release liner 44 is not particularly limited, but as a material that can be satisfactorily separated from the absorption expansion layer 42 and the adhesive layer 43, a plastic film (for example, polyethylene, polypropylene, polyester, polyethylene terephthalate, or a laminated composite thereof) is used. ), Paper (for example, high-quality paper, glassin paper, kraft paper, etc.) can be preferably used. Further, in order to facilitate the peeling of the release liner 44, for example, a silicone-based resin treatment or a fluorine-based resin treatment may be applied to the adhesive surface side as a surface treatment.

Further, the absorption / expansion portion 40 is provided with a take-out member 45 for taking out from the inside of the fistula H. The take-out member 45 is a member for taking out the sheet-shaped absorption / expansion portion 40 from the inside of the fistula H, and includes a base portion 45a and a tension portion 45b in which a portion exposed to the outside of the body is gripped and pulled. Both the base portion 45a and the tension portion 45b are elongated strings or bands.

The base portion 45a extends along the edge of the absorption expansion portion 40 on the side of the internal locking portion 10. As shown in FIG. 3, specifically, the base portion 45a is an edge portion of the support layer 41 on the internal locking portion 10 side in a direction orthogonal to the axial direction of the tube 20 (longitudinal direction Y of the absorption expansion portion 40). It will be extended along. Therefore, when the absorption expansion portion 40 is attached to the tube 20, it is provided along the outer diameter direction of the tube 20. The base portion 45a is preferably provided over the entire length of the absorption expansion portion 40 in the longitudinal direction Y in order to reliably remove the absorption expansion portion 40 from the fistula H, but even if the base portion 45a is provided in a part of the support layer 41. good.

The tension portion 45b is provided so that one end is connected to the support layer 41 and the other end is exposed to the outside of the body. As shown in FIG. 3, specifically, the tension portion 45b is connected to the base portion 45a provided on the support layer 41 at one end, and the tube 20 is connected to the support layer 41 so that the other end is exposed to the outside of the body. Is provided along the axial direction of (X in the lateral direction X of the absorption expansion portion 40). The tension portion 45b is provided perpendicular to the extending direction of the base portion 45a.

The tension portion 45b may be provided on either the upper surface or the lower surface of the support layer 41, but the adhesive layer 43 is provided in order to efficiently peel the adhesive layer 43 from the surface of the tube 20 when the absorption expansion portion 40 is taken out. It is preferably provided on the provided side surface. As a result, the tensile force with respect to the support layer 41 is more easily transmitted and the adhesive layer 43 adhering to the tube 20 is more easily peeled off than when the tension portion 45b is provided on the surface of the support layer 41 on the side where the absorption expansion layer 42 is provided. Become. Further, by providing the tension portion 45b on the adhesive layer 43 side, the absorption expansion portion 40 is easily taken out by being wound upward so that the adhesive layer 43 is on the outside.

Further, the tension portion 45b is preferably provided so as to be located substantially in the center of the support layer 41 as shown in FIG. 3 in consideration of the ease of taking out the absorption expansion portion 40 from the fistula H. At this time, the intersection of the base portion 45a and the tension portion 45b is located substantially at the center of the support layer 41 in the longitudinal direction Y as shown in FIG. With such an arrangement, when the tension portion 45b is pulled, the tensile force is gradually transmitted from the central position to the left and right directions with respect to the base portion 45a, so that the absorption expansion portion 40 is not cut in the middle. Can be taken out.

Further, the tension portion 45b in the present embodiment has one base portion 45a and one tension portion 45b, but the number thereof is not particularly limited.

[motion]
Next, an example of using the transfistula tube device 100 according to the present embodiment will be described with reference to FIGS. 5 to 9. FIGS. 5 to 9 show the state of the transfistula tube device 100 until the gastrostomy constructed in the patient undergoes the acute phase and the absorption and expansion portion 40 is removed.

As shown in FIG. 5, the transfistula tube device 100 is attached to the constructed fistula H. The tube 20 of the transfistula tube device 100 is attached by winding the absorption expansion layer 42 around the tube 20 so as to face outward along the outer peripheral surface.

Further, in the transfistula tube device 100, the internal locking portion 10 is expanded and locked in a state of being in contact with the inner surface of the tube wall (stomach wall) Dw of the digestive tract (stomach) D, and the external locking portion 30 is the body. Locked to the table.

As shown in FIG. 6, the absorption-expanding portion 40 gradually expands when it absorbs the leaked liquid leaked from the fistula H in the acute phase. As a result, the gap between the fistula H and the absorption / expansion portion 40 is filled, and the fistula H is compressed to prevent the leaked liquid from leaking out of the body and suppress the irritation caused by the contact with the tube 20. Will be done.

As shown in FIG. 7, at the timing when the fistula H shifts from the acute phase to the chronic phase, the medical worker pulls the extraction member 45 exposed on the body surface while grasping it to take out the absorption / expansion portion 40. , The state shown in FIG. In the chronic phase, the transfistula tube device 100 is used with the absorption swelling portion 40 removed.

Further, as shown in FIG. 9, when the supply of the fluid F to the patient by the tube feeding method is completed, the connector 210 of the extracorporeal tube 200 is removed, and the lid portion 35 is fitted to the supply port 32 and closed. Cover. This prevents foreign matter from entering the digestive tract from the supply port 32.

[Action effect]
As described above, the transfistula tube device 100 according to the present embodiment includes a lumen 21 that communicates from the distal end side to the proximal end side, and includes the patient's abdominal wall Aw and the gastrointestinal tract D, which is the gastric tube wall Dw ( It has a tube 20 that is inserted into a fistula H constructed through the stomach wall), and the tube 20 is provided with at least a part thereof so as to be located in the fistula H and leaks from the fistula H. An absorption expansion unit 40 that absorbs and expands is provided.

With such a configuration, the absorption expansion unit 40 absorbs the leaked liquid leaking from the constructed fistula H, so that an effect of suppressing skin troubles caused by the leaked liquid can be obtained. Further, since the absorption expansion portion 40 absorbs the leaked liquid and expands in the fistula H, the leakage of the leaked liquid from the fistula H is prevented, and the surface of the fistula H serving as a wound portion comes into contact with the tube 20. Stimulation by. Therefore, the transfistula tube device 100 can simplify the management in the acute phase from the construction of the fistula H, which needs to be managed according to the pathological condition of the patient and the condition of the wound, to the completion.

Further, the transfistula tube device 100 according to the present embodiment is provided with a body inner flow path 11 communicating with the tip side of the lumen 21, is provided on the tip side of the tube 20, and is locked inside the tube wall Dw. A configuration may be configured in which a stop portion 10 and an extracorporeal locking portion 30 having a body outer flow path 33 communicating with the base end side of the lumen 21 and provided on the base end side of the tube 20 and locked to the body surface are provided.

With such a configuration, the transfistula tube device 100 is connected to the abdominal wall Aw and the tube by the internal locking portion 10 provided on the distal end side of the tube 20 and the external locking portion 30 provided on the proximal end side of the tube 20. Since it can be fixed to the patient with the wall Dw sandwiched between them, the effect of preventing accidental removal is achieved.

Further, in the transfistula tube device 100 according to the present embodiment, the absorption expansion portion 40 is provided on one surface of the support layer 41 serving as a substrate and the support layer 41 to absorb the leaked liquid leaking from the fistula H. A sheet having an expanding absorption expansion layer 42 and an adhesive layer 43 provided on the other surface of the support layer 41 and adhering to the tube 20, and placed in the fistula H in a state of being detachably attached to the tube 20. It may be a body structure.

With such a configuration, since the absorption / expansion portion 40 can be detached from the tube 20, the absorption / expansion portion 40 can be removed from the fistula H at an arbitrary timing. Therefore, for example, if the absorption / expansion portion 40 is removed at the timing when the fistula H is constructed and completed after the acute phase, it is possible to prevent a problem caused by the absorption expansion portion 40 being placed in the fistula H.

Further, in the transfistula tube device 100 according to the present embodiment, the absorption expansion portion 40 may be configured to include a take-out member 45 for taking out from the fistula H. Further, the take-out member 45 has a base portion 45a provided along the edge portion of the absorption expansion portion 40 on the internal locking portion 10 side, and one end thereof is connected to the base portion 45a so that the other end is exposed to the body surface. A configuration may be provided in which a tension portion 45b is provided in the absorption expansion portion 40 along the axial direction of the tube 20 and the exposed portion is pulled when the absorption expansion portion 40 is taken out.

With such a configuration, it is only necessary to pull the tension portion 45b when taking out the absorption / expansion portion 40, so that the taking-out work becomes easy.

Further, in the transfistula tube device 100 according to the present embodiment, the tension portion 45b may be provided so as to be located substantially in the center of the absorption expansion portion 40.

When the absorption expansion portion 40 is taken out, the tension portion 45b is pulled, and the tensile force during this pulling operation is applied to substantially the center of the absorption expansion portion 40. Therefore, it is prevented that the tensile force with respect to the absorption / expansion portion 40 is unbalancedly transmitted, and the force can be smoothly taken out from the fistula H.

Further, in the transfistula tube device 100 according to the present embodiment, the tension portion 45b may be provided on the surface side of the support layer 41 where the adhesive layer 43 is provided.

With such a configuration, the tensile force with respect to the support layer 41 is more easily transmitted than that provided on the surface of the support layer 41 on the side where the absorption expansion layer 42 is provided, so that the adhesive layer 43 can be easily peeled off from the tube 20.

[Other Embodiments]
The present invention is not limited to the above embodiment, and can be appropriately modified and implemented according to the usage environment and the like as shown below, for example. Further, the following modifications can be carried out in any combination within a range that does not deviate from the gist of the present invention.

In the above-described embodiment, the absorption / expansion portion 40 has been described as being a sheet body and taken out of the body after a predetermined period of time has elapsed, but the present invention is not limited to this. The absorption expansion portion 40 has, for example, a configuration in which a material having the same function as the absorption expansion portion 40 is applied to the surface of the tube 20, and a configuration in which a material having the same function as the absorption expansion portion 40 is used on the outer peripheral surface of the tube 20. The transfistula tube device 100 may be indwelled in the fistula H from the time when the transfistula tube device 100 is attached to the fistula H until it is removed at the time of replacement without being separated from the tube 20.

FIG. 10 shows a configuration in which a material having the function of the absorption / expansion portion 40 is applied to the surface of the tube 20. With such a configuration, it is not necessary to remove the absorption / expansion portion 40 at the timing of transition from the acute phase to the chronic phase, and the management of the fistula H becomes simpler.

When such a configuration is adopted, it is necessary to prevent a problem with the fistula H in which the absorption / expansion portion 40 is to be indwelled from the acute phase in which the fistula H is completed to the replacement phase through the chronic phase. There is. As a countermeasure against this, additives such as antibacterial agents, bactericides, and anti-inflammatory agents that can prevent or alleviate problems that may occur in the fistula H are added for a predetermined period (for example, between the time when the fistula H is constructed and the time when the fistula H is replaced). The configuration may be such that it can be released slowly.

10 Internal locking part 11 Body inner flow path 20 Tube 21 Lumen 30 External locking part 31 Main body 32 Supply port 33 Body outer flow path 34 Hinge 35 Lid (35a top plate, 35b side wall, 35c engaging recess)
40 Absorption expansion part 41 Support layer 42 Absorption expansion layer 43 Adhesive layer (43a adhesive part, 43b support part)
44 Release liner 45 Extraction member (45a base, 45b tension)
100 Transfistula tube device 200 Extracorporeal tube 210 Connector 300 Container 310 Outlet Aw Abdominal wall D Digestive tract Dw Tube wall F Leakage H Fistula

Claims (9)

It has a lumen that communicates from the distal end to the proximal side and has a tube that is inserted into a fistula constructed through the patient's abdominal wall and gastrointestinal tract wall.
A transfistula tube device, wherein the tube is provided with an absorption-expanding portion that is provided so that at least a part thereof is located in the fistula and absorbs and expands a leaked liquid leaking from the fistula. The body inner flow path communicating with the tip side of the lumen, the body locking portion provided on the tip side of the tube and locked inside the tube wall, and the absorption expansion portion The transfistula tube device according to claim 1, which is provided above the proximal end side of the internal locking portion. According to claim 1 or 2, a body outer flow path communicating with the base end side of the lumen is provided, and an extracorporeal locking portion provided on the base end side of the tube and locked to the body surface is provided. The transfistula tube device described. The absorption expansion part
The support layer that serves as the substrate and
An absorbent expansion layer provided on one surface of the support layer and expanding by absorbing the leaked liquid,
It has an adhesive layer provided on the other surface of the support layer and adheres to the tube.
The transfistula tube device according to any one of claims 1 to 3, which is a sheet body that is placed in the fistula in a state of being detachably attached to the tube. The transfistula tube device according to any one of claims 1 to 4, wherein the absorption and expansion portion includes a take-out member for taking out from the fistula. The take-out member is
A base provided along the edge of the absorption expansion portion on the side of the internal locking portion, and
A tension portion provided on the absorption expansion portion along the axial direction of the tube and pulled when the absorption expansion portion is taken out so that one end is connected to the base portion and the other end is exposed to the body surface. The transfistula tube device according to claim 5. The transfistula tube device according to claim 6, wherein the tension portion is provided so as to be located substantially at the center of the absorption expansion portion. The transfistula tube device according to claim 6 or 7, wherein the tension portion is provided on the surface of the support layer on the side where the adhesive layer is provided. The transfistula tube device according to any one of claims 1 to 8, wherein the fistula is a gastrostomy and the gastrointestinal tract is a stomach.

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