JP2012165861A - Indwelling aid implement used for fistula catheter, and fistula catheter - Google Patents

Indwelling aid implement used for fistula catheter, and fistula catheter Download PDF

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JP2012165861A
JP2012165861A JP2011028483A JP2011028483A JP2012165861A JP 2012165861 A JP2012165861 A JP 2012165861A JP 2011028483 A JP2011028483 A JP 2011028483A JP 2011028483 A JP2011028483 A JP 2011028483A JP 2012165861 A JP2012165861 A JP 2012165861A
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end side
indwelling
diameter
auxiliary tool
tube
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JP5769438B2 (en
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Shigeaki Funamura
重彰 船村
Natsuko Yamoto
奈津子 矢元
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Nippon Covidien Ltd
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Nippon Covidien Ltd
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Priority to JP2011028483A priority Critical patent/JP5769438B2/en
Priority to PCT/US2012/025020 priority patent/WO2012112526A2/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00Feeding-tubes for therapeutic purposes
    • A61J15/0026Parts, details or accessories for feeding-tubes
    • A61J15/003Means for fixing the tube inside the body, e.g. balloons, retaining means
    • A61J15/0034Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters
    • A61J15/0038Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters expandable, e.g. umbrella type
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00Feeding-tubes for therapeutic purposes
    • A61J15/0015Gastrostomy feeding-tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • A61M2025/0293Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Surgical Instruments (AREA)

Abstract

PROBLEM TO BE SOLVED: To provide an indwelling aid implement used for a fistula catheter to stabilize holding of a member for forming a bumper-shaped intracorporeal fixed part.SOLUTION: The indwelling aid implement 60 is formed with a cylindrical body part 60A on the distal end side. The cylindrical body part 60A includes a distal end side holding part 63 holding one axial end side of the intracorporeal fixed part B with the cylindrical body part 60A inserted therein, and a proximal end side holding part 64 formed on the proximal end side rather than the distal end side holding part 63 to hold the other axial end side of the intracorporeal fixed part B with the cylindrical body part 60A inserted therein, so as to be axially movable on the outer peripheral surface.

Description

本発明は、患者の消化管内に流動食や栄養剤等の流体物を供給するために用いられる瘻孔カテーテルに用いられる留置補助具及び瘻孔カテーテルに関する。   The present invention relates to an indwelling aid and a fistula catheter used for a fistula catheter used to supply fluids such as liquid foods and nutrients into the digestive tract of a patient.

従来、高齢や疾病により自力で口から食べ物を摂取する機能が低下した人(以下、患者と記す。)に対して、瘻孔カテーテルを用いて流動食や栄養剤等を供給する経腸栄養投与が行われている。経腸栄養投与においては、患者の腹部に瘻孔(胃瘻)を造設し、この瘻孔に瘻孔カテーテルを装着し、瘻孔カテーテルを通じて患者に流動食等を供給する。   Conventionally, enteral nutritional administration that supplies liquid foods, nutrients, etc. using a fistula catheter to people who have the ability to ingest food by mouth due to aging or illness (hereinafter referred to as patients) has been Has been done. In enteral nutrition administration, a fistula (gastric fistula) is constructed in the patient's abdomen, a fistula catheter is attached to the fistula, and liquid food or the like is supplied to the patient through the fistula catheter.

このような経腸栄養投与に用いられる瘻孔カテーテルは、体内側に設置される体内固定部の形状によって、いわゆるバルーン型とバンパー型とに大別できる。
バンパー型の体内固定部として、チューブの外周に形成された複数のスリットにより翼部を形成し、この翼部が伸長/圧潰されることにより体内固定部が形成されるものが提案されている(例えば、特許文献1参照)。
Such a fistula catheter used for enteral nutrition administration can be roughly classified into a so-called balloon type and a bumper type depending on the shape of the in-vivo fixing portion installed inside the body.
As a bumper-type in-vivo fixing portion, a wing portion is formed by a plurality of slits formed on the outer periphery of the tube, and the in-vivo fixing portion is formed by extending / collapsing the wing portion ( For example, see Patent Document 1).

特開2008−541842号公報(第6頁、図4)JP 2008-541842 A (page 6, FIG. 4)

上記特許文献1に記載の体内固定部は、圧潰されたときに翼部が折れ曲がって放射状に花弁のように広がることで、チューブの直径よりも大きい直径を有する部分(バンパー)を形成している。そして、このバンパーにより、瘻孔カテーテルを胃壁などの消化管壁内に固定するよう構成されている。特許文献1に記載のバンパーは、先端がフック形状に変化するキャッチという部材を用いて形成される。   The in-vivo fixed part described in Patent Document 1 forms a part (bumper) having a diameter larger than the diameter of the tube by bending the wing part and expanding radially like a petal when crushed. . And it is comprised by this bumper so that a fistula catheter may be fixed in digestive tract walls, such as a stomach wall. The bumper described in Patent Document 1 is formed using a member called a catch whose tip changes to a hook shape.

バンパーをたとえば胃内に留置する場合、キャッチという部材も一緒に胃内に留置されることになる。キャッチという部材が胃内に留置されると、その全体が胃液や栄養剤等に晒されることになる。そうすると、キャッチを形成している材料が劣化して、強度が低下することになる。キャッチの強度が低下すると、バンパーを形成しているカラー部の弾性に負け、バンパー形状が維持できなくなってしまう。そのような場合に、患者が瘻孔カテーテルを引き抜こうとすると、簡単に瘻孔カテーテルが抜けてしまうことがあった。   For example, when the bumper is placed in the stomach, a member called a catch is also placed in the stomach together. When a member called a catch is left in the stomach, the whole is exposed to gastric juice, nutrients, and the like. If it does so, the material which forms catch will deteriorate and strength will fall. If the strength of the catch is reduced, it loses the elasticity of the collar part forming the bumper and the bumper shape cannot be maintained. In such a case, when the patient tried to pull out the fistula catheter, the fistula catheter could easily be removed.

本発明は、上記のような課題を解決するためになされたものであり、瘻孔カテーテルに用いられ、体内固定部を形成する部材の保持の安定化を図るようにした留置補助具、及び、その留置補助具を備えた瘻孔カテーテルを提供するものである。   The present invention has been made in order to solve the above-described problems, and is used for a fistula catheter, and an indwelling assisting device for stabilizing the holding of a member forming a body fixing portion, and its A fistula catheter provided with an indwelling aid is provided.

本発明に係る留置補助具は、瘻孔カテーテルに形成される体内固定部の留置補助具であって、体内固定部に少なくとも一部が挿入される筒状本体部を有し、筒状本体部は、先端側に形成され、筒状本体部が挿入された体内固定部の軸方向の一端側を保持する先端側保持部と、先端側保持部よりも基端側に形成され、筒状本体部が挿入された体内固定部の軸方向の他端側を外周面で軸方向に移動可能に保持する基端側保持部と、を備えたものである。   An indwelling assisting device according to the present invention is an indwelling assisting device for an in-vivo fixing portion formed on a fistula catheter, and has a cylindrical main body portion at least partially inserted into the in-vivo fixing portion, A distal end side holding portion that holds one end side in the axial direction of the in-vivo fixed portion that is formed on the distal end side and in which the cylindrical main body portion is inserted, and is formed closer to the proximal end side than the distal end side holding portion. And a proximal end side holding portion that holds the other end side in the axial direction of the in-vivo fixed portion inserted therein so as to be movable in the axial direction on the outer peripheral surface.

本発明に係る留置補助具は、先端側保持部が、径方向外側に向かって突出させた部分を少なくとも一つ備えているものである。   The indwelling auxiliary tool according to the present invention is provided with at least one portion in which the tip side holding portion protrudes radially outward.

本発明に係る留置補助具は、先端側保持部が、径方向外側に向かって拡径したつば状の第1拡径部と、第1拡径部の基端側に形成され、径方向内側に向かって第1拡径部よりも縮径した縮径部と、縮径部の基端側に形成され、径方向外側に向かって拡径した第2拡径部と、を有しているものである。   The indwelling auxiliary tool according to the present invention has a distal-end-side holding portion formed on a flange-shaped first diameter-expanded portion whose diameter increases toward the outer side in the radial direction, and a proximal end side of the first diameter-expanded portion. A diameter-reduced portion that is smaller than the first diameter-increased portion, and a second diameter-increased portion that is formed on the proximal end side of the diameter-reduced portion and that is diameter-expanded radially outward. Is.

本発明に係る留置補助具は、縮径部が、先端側保持部の外壁の少なくとも一部を径方向に突出させて形成した突起部を備えているものである。   In the indwelling auxiliary tool according to the present invention, the reduced diameter portion includes a protruding portion formed by protruding at least a part of the outer wall of the distal end side holding portion in the radial direction.

本発明に係る留置補助具は、第2拡径部は、第2拡径部の外周の少なくとも一部を先端方向に立設させて形成した突起部を備えているものである。   In the indwelling auxiliary tool according to the present invention, the second enlarged diameter portion includes a protrusion formed by standing at least a part of the outer periphery of the second enlarged diameter portion in the distal direction.

本発明に係る留置補助具は、先端側保持部に対して、体内固定部の軸方向の一端側を外周側から締結する締結部を設けたものである。   The indwelling auxiliary tool according to the present invention is provided with a fastening portion that fastens one end side in the axial direction of the in-vivo fixing portion from the outer peripheral side with respect to the distal end side holding portion.

本発明に係る留置補助具は、基端側保持部の外周面の少なくとも一部を、先端側から基端側に向けてテーパー形状にしているものである。   In the indwelling auxiliary tool according to the present invention, at least a part of the outer peripheral surface of the proximal end side holding portion is tapered from the distal end side toward the proximal end side.

本発明に係る留置補助具は、基端側保持部の外周面の少なくとも一部に径方向外側に向かって拡径した拡径部を設け、その拡径部から基端側に向けてテーパー形状にしているものである。   The indwelling auxiliary tool according to the present invention is provided with a diameter-enlarged portion that expands radially outward in at least a part of the outer peripheral surface of the proximal-side holding portion, and is tapered from the expanded-diameter portion toward the proximal side. It is what you are doing.

本発明に係る留置補助具は、先端側保持部と基端側保持部との間における流体が流通可能な貫通穴を壁面の少なくとも一部に形成したものである。   The indwelling auxiliary tool according to the present invention has a through hole formed in at least a part of a wall surface through which a fluid can flow between a distal end side holding portion and a proximal end side holding portion.

本発明に係る留置補助具は、筒状本体部の内腔の径を、筒状本体部の内腔に挿入される伸展具の係合部の径に基づいて決定しているものである。   In the indwelling auxiliary tool according to the present invention, the diameter of the lumen of the cylindrical main body is determined based on the diameter of the engaging portion of the extender inserted into the lumen of the cylindrical main body.

本発明に係る留置補助具は、筒状本体部の内腔に内部突起を形成し、この内部突起によって、筒状本体部の内腔に挿入される伸展具の係合部が係止されるものである。   The indwelling auxiliary tool according to the present invention forms an internal projection in the lumen of the cylindrical main body, and the internal projection locks the engaging portion of the extender inserted into the lumen of the cylindrical main body. Is.

本発明に係る瘻孔カテーテルは、上記の留置補助具と、チューブを備えたカテーテル部と、カテーテル部の遠位端側に形成され、消化管壁内に留置される体内固定部と、を有する瘻孔カテーテルにおいて、体内固定部は、チューブの先端部が留置補助具の先端側保持部に固定された状態で、チューブの先端側と基端側とを近づけることにより、チューブの一部が径方向外側に向かって延び、さらにこれと反対側に屈曲して径方向内側に向かって延びる形状に変形させ、チューブの変形位置から基端側でチューブを基端側保持部で保持することで形成しているものである。   A fistula catheter according to the present invention includes the above-mentioned indwelling auxiliary tool, a catheter part provided with a tube, and a body fixing part formed on the distal end side of the catheter part and placed in the digestive tract wall. In the catheter, the in-vivo fixing part is configured such that a part of the tube is radially outside by bringing the distal end side and the proximal end side of the tube close to each other in a state where the distal end part of the tube is fixed to the distal side holding part of the indwelling auxiliary tool. It is formed by holding the tube on the proximal side from the deformed position of the tube and holding it with the proximal side holding part. It is what.

本発明に係る留置補助具は、先端側に形成され、筒状本体部が挿入された体内固定部の軸方向の一端側を保持する先端側保持部と、先端側保持部よりも基端側に形成され、筒状本体部が挿入された体内固定部の軸方向の他端側を外周面で軸方向に移動可能に保持する基端側保持部と、を備えた筒状本体部を有しているので、形成された体内固定部の軸方向の他端側を基端側保持部で保持した状態において先端側保持部及び基端側保持部の外周面、つまり体内固定部の保持部分が胃液や栄養剤等に晒されることなく、体内固定部の一端側及び他端側の保持を安定的に維持することができる。このため、体内固定部を形成している材料の弾性等に依存することなく、体内固定部の形状を安定して維持することが可能になる。   The indwelling assisting device according to the present invention is formed on the distal end side, a distal end side holding portion that holds one axial end side of the in-vivo fixing portion into which the cylindrical main body portion is inserted, and a proximal end side relative to the distal end side holding portion And a proximal end side holding portion that holds the other end side in the axial direction of the in-vivo fixed portion into which the cylindrical body portion is inserted so as to be movable in the axial direction on the outer peripheral surface. Therefore, in the state where the other end side in the axial direction of the formed body fixing part is held by the base side holding part, the outer peripheral surface of the distal end side holding part and the base end side holding part, that is, the holding part of the body fixing part Can be stably maintained without being exposed to gastric juice, nutrients, or the like. For this reason, it becomes possible to stably maintain the shape of the in-vivo fixing part without depending on the elasticity of the material forming the in-vivo fixing part.

本発明に係る留置補助具は、先端側保持部が、径方向外側に向かって突出させた部分を少なくとも一つ備えているので、比較的簡易な構造で体内固定部の一端側を保持できる。   In the indwelling auxiliary tool according to the present invention, since the distal end side holding portion includes at least one portion protruding radially outward, the one end side of the in-vivo fixing portion can be held with a relatively simple structure.

本発明に係る留置補助具は、先端側保持部が、径方向外側に向かって拡径したつば状の第1拡径部と、第1拡径部の基端側に形成され、径方向内側に向かって第1拡径部よりも縮径した縮径部と、縮径部の基端側に形成され、径方向外側に向かって拡径した第2拡径部と、を有しているので、比較的簡易な構造で体内固定部の一端側を保持できる。   The indwelling auxiliary tool according to the present invention has a distal-end-side holding portion formed on a flange-shaped first diameter-expanded portion whose diameter increases toward the outer side in the radial direction, and a proximal end side of the first diameter-expanded portion. A diameter-reduced portion that is smaller than the first diameter-increased portion, and a second diameter-increased portion that is formed on the proximal end side of the diameter-reduced portion and that is diameter-expanded radially outward. Therefore, the one end side of the in-vivo fixing part can be held with a relatively simple structure.

本発明に係る留置補助具は、縮径部が、先端側保持部の外壁の少なくとも一部を径方向に突出させて形成した突起部を備えているので、比較的簡易な構造で体内固定部の一端側を保持できる。   In the indwelling assisting device according to the present invention, the reduced diameter portion includes a protruding portion formed by protruding at least a part of the outer wall of the distal end side holding portion in the radial direction. Can be held at one end.

本発明に係る留置補助具は、第2拡径部は、第2拡径部の外周の少なくとも一部を先端方向に立設させて形成した突起部を備えているので、比較的簡易な構造で体内固定部の一端側を引っかけ保持することができる。   The indwelling auxiliary tool according to the present invention has a relatively simple structure because the second enlarged diameter portion includes a protrusion formed by standing at least a part of the outer periphery of the second enlarged diameter portion in the distal direction. Thus, one end side of the body fixing part can be hooked and held.

本発明に係る留置補助具は、先端側保持部に対して、体内固定部の軸方向の一端側を外周側から締結する締結部を設けたので、更に強固に体内固定部の一端側を保持することが可能になる。   In the indwelling auxiliary tool according to the present invention, since the fastening portion that fastens one end side in the axial direction of the in-vivo fixing portion from the outer peripheral side is provided with respect to the tip-side holding portion, the one end side of the in-vivo fixing portion is more firmly held. It becomes possible to do.

本発明に係る留置補助具は、基端側保持部の外周面の少なくとも一部を、先端側から基端側に向けてテーパー形状にしているので、比較的簡易な構造で体内固定部の他端側を保持することができる。   In the indwelling auxiliary tool according to the present invention, at least a part of the outer peripheral surface of the proximal end side holding portion is tapered from the distal end side toward the proximal end side. The end side can be held.

本発明に係る留置補助具は、基端側保持部の外周面の少なくとも一部に径方向外側に向かって拡径した拡径部を設け、その拡径部から基端側に向けてテーパー形状にしているので、更に強固に体内固定部の他端側を保持することができる。   The indwelling auxiliary tool according to the present invention is provided with a diameter-enlarged portion that expands radially outward in at least a part of the outer peripheral surface of the proximal-side holding portion, and is tapered from the expanded-diameter portion toward the proximal side. Therefore, the other end side of the in-vivo fixed part can be held more firmly.

本発明に係る留置補助具は、先端側保持部と基端側保持部との間における流体が流通可能な貫通穴を壁面の少なくとも一部に形成したので、流体を安定的に、また多方向に供給することが可能になる。   In the indwelling auxiliary tool according to the present invention, the through hole through which the fluid between the distal end side holding portion and the proximal end side holding portion can flow is formed in at least a part of the wall surface. It becomes possible to supply to.

本発明に係る留置補助具は、筒状本体部の内腔の径を、筒状本体部の内腔に挿入される伸展具の係合部の径に基づいて決定しているので、留置補助具の内腔の構成を伸展具の構成に応じて簡素化することができる。また、簡素な構成でありながら、伸展具との係止をより強固なものとすることが可能になる。   In the indwelling aid according to the present invention, the diameter of the lumen of the cylindrical main body is determined based on the diameter of the engaging portion of the extender inserted into the lumen of the cylindrical main body. The configuration of the lumen of the device can be simplified according to the configuration of the extension device. Moreover, although it is a simple structure, it becomes possible to make latching with an extension tool stronger.

本発明に係る留置補助具は、筒状本体部の内腔に内部突起を形成し、この内部突起によって、筒状本体部の内腔に挿入される伸展具の係合部が係止されるので、留置補助具の内腔の構成を簡素化することができる。また、簡素な構成でありながら、伸展具との係止をより強固なものとすることが可能になる。   The indwelling auxiliary tool according to the present invention forms an internal projection in the lumen of the cylindrical main body, and the internal projection locks the engaging portion of the extender inserted into the lumen of the cylindrical main body. Therefore, the configuration of the lumen of the indwelling aid can be simplified. Moreover, although it is a simple structure, it becomes possible to make latching with an extension tool stronger.

本発明に係る瘻孔カテーテルは、上記の留置補助具と、チューブを備えたカテーテル部と、カテーテル部の遠位端側に形成され、消化管壁内に留置される体内固定部と、を有する瘻孔カテーテルにおいて、体内固定部は、チューブの先端部が留置補助具の先端側保持部に固定された状態で、チューブの先端側と基端側とを近づけることにより、チューブの一部が径方向外側に向かって延び、さらにこれと反対側に屈曲して径方向内側に向かって延びる形状に変形させ、チューブの変形位置から基端側でチューブを基端側保持部で保持することで形成しているので、体内固定部の形状を安定して維持することができる。したがって、体表側から瘻孔カテーテルが引っ張られた場合でも、体内固定部の形状が維持されるので、瘻孔から瘻孔カテーテルが抜けにくい。   A fistula catheter according to the present invention includes the above-mentioned indwelling auxiliary tool, a catheter part provided with a tube, and a body fixing part formed on the distal end side of the catheter part and placed in the digestive tract wall. In the catheter, the in-vivo fixing part is configured such that a part of the tube is radially outside by bringing the distal end side and the proximal end side of the tube close to each other in a state where the distal end part of the tube is fixed to the distal side holding part of the indwelling auxiliary tool. It is formed by holding the tube on the proximal side from the deformed position of the tube and holding it with the proximal side holding part. Therefore, the shape of the in-vivo fixed part can be stably maintained. Therefore, even when the fistula catheter is pulled from the body surface side, the shape of the in-vivo fixing part is maintained, so that the fistula catheter is not easily removed from the fistula.

実施の形態に係る留置補助具の構成例の一つを示す概略図である。It is the schematic which shows one of the structural examples of the indwelling assistance tool which concerns on embodiment. 実施の形態に係る留置補助具を用いた瘻孔カテーテルの要部模式図である。It is a principal part schematic diagram of the fistula catheter using the indwelling auxiliary tool which concerns on embodiment. 実施の形態に係る瘻孔カテーテルの体内固定部を伸展させる動作を断面で示す模式図である。It is a schematic diagram which shows the operation | movement which extends the body fixing | fixed part of the fistula catheter which concerns on embodiment in a cross section. 実施の形態に係る瘻孔カテーテルの斜視図である。It is a perspective view of a fistula catheter concerning an embodiment. 実施の形態に係る瘻孔カテーテルの側面図である。It is a side view of a fistula catheter concerning an embodiment. 実施の形態に係る瘻孔カテーテルの平面図である。It is a top view of a fistula catheter concerning an embodiment. 実施の形態に係る瘻孔カテーテルの底面図である。It is a bottom view of a fistula catheter concerning an embodiment. 実施の形態に係る瘻孔カテーテルの伸展状態を示す側面模式図である。It is a side surface schematic diagram which shows the extension state of the fistula catheter which concerns on embodiment. 図8のA−A矢視断面模式図である。It is an AA arrow cross-sectional schematic diagram of FIG. 実施の形態1に係る瘻孔カテーテルの挿入/抜去動作を説明する図である。FIG. 10 is a diagram for explaining the insertion / extraction operation of the fistula catheter according to the first embodiment. 実施の形態に係る瘻孔カテーテルの留置状態を説明する図である。It is a figure explaining the indwelling state of the fistula catheter concerning an embodiment. 実施の形態に係る留置補助具の別の構成例を示す概略断面図である。It is a schematic sectional drawing which shows another structural example of the indwelling assistance tool which concerns on embodiment. 実施の形態に係る留置補助具の更に別の構成例を示す概略図である。It is the schematic which shows another structural example of the indwelling assistance tool which concerns on embodiment. 実施の形態に係る留置補助具の更に別の構成例を示す概略図である。It is the schematic which shows another structural example of the indwelling assistance tool which concerns on embodiment. 実施の形態に係る留置補助具の更に別の構成例を示す概略断面図である。It is a schematic sectional drawing which shows another structural example of the indwelling assistance tool which concerns on embodiment. 実施の形態に係る留置補助具の更に別の構成例を示す概略断面図である。It is a schematic sectional drawing which shows another structural example of the indwelling assistance tool which concerns on embodiment. 実施の形態に係る留置補助具の先端側保持部の一例を示す説明図である。It is explanatory drawing which shows an example of the front end side holding part of the indwelling assistance tool which concerns on embodiment. 実施の形態に係る留置補助具の先端側保持部の別の一例を示す説明図である。It is explanatory drawing which shows another example of the front end side holding part of the indwelling assistance tool which concerns on embodiment.

以下、本発明の実施の形態を図面に基づいて説明する。
図1は、実施の形態に係る留置補助具60の構成例の一つを示す概略図である。図17は、先端側保持部63の一例を示す説明図である。図18は、先端側保持部63の別の一例を示す説明図である。図1、図17、図18に基づいて、留置補助具60の構成について説明する。図1(a)が留置補助具60の側面図を、図1(b)が留置補助具60の断面図を、それぞれ示している。留置補助具60は、瘻孔カテーテルの先端側に形成されるいわゆるバンパー形状の体内固定部の形状を維持するのに寄与する機能を有するものである。なお、図1を含め、以下の図面では各構成部材の大きさの関係が実際のものとは異なる場合がある。
Hereinafter, embodiments of the present invention will be described with reference to the drawings.
FIG. 1 is a schematic diagram showing one configuration example of an indwelling auxiliary tool 60 according to the embodiment. FIG. 17 is an explanatory diagram illustrating an example of the distal end side holding portion 63. FIG. 18 is an explanatory view showing another example of the distal end side holding portion 63. Based on FIG.1, FIG.17, FIG.18, the structure of the indwelling auxiliary tool 60 is demonstrated. FIG. 1A shows a side view of the indwelling auxiliary tool 60, and FIG. 1B shows a cross-sectional view of the indwelling auxiliary tool 60. The indwelling auxiliary tool 60 has a function that contributes to maintaining the shape of a so-called bumper-shaped in-vivo fixing part formed on the distal end side of the fistula catheter. In addition, in the following drawings including FIG. 1, the relationship of the size of each component may be different from the actual one.

留置補助具60は、ステンレス、チタン等の金属、又は、ポリウレタン等の樹脂で構成され、内部に流体物を通過させるための内腔を有している。なお、留置補助具60の構成材料を特に限定するものではないが、胃内等に留置されるため、胃液や栄養剤等によって劣化しにくい生体適合性材料で構成するとよい。   The indwelling auxiliary tool 60 is made of a metal such as stainless steel or titanium, or a resin such as polyurethane, and has a lumen for allowing a fluid to pass therethrough. In addition, although the constituent material of the indwelling auxiliary tool 60 is not specifically limited, since it is indwelled in the stomach etc., it is good to comprise with the biocompatible material which cannot be easily deteriorated by gastric juice, a nutrient, etc.

図1(a)に示すように、留置補助具60は、体内固定部が形成される部材(たとえば、瘻孔カテーテルを形成するチューブやそのチューブの先端に取り付けられ、変形可能な樹脂材料で少なくとも一部が筒状に形成された部材等、以下体内固定部形成部材と称する)の内径よりも大きな外径を有し、体内固定部の形成側に少なくとも一部が挿入される筒状本体部60Aを有している。この筒状本体部60Aは、先端側保持部63と、基端側保持部64と、中間部66と、で構成されている。なお、「先端」とは、体内への挿入側をいい、図1における図面下側を示す。「基端」とは先端の反対側をいい、図1における図面上側を示す。   As shown in FIG. 1 (a), the indwelling auxiliary tool 60 is a member (for example, a tube forming a fistula catheter or a distal end of the tube, and is formed of a deformable resin material. A cylindrical main body portion 60A having an outer diameter larger than the inner diameter of a member in which the portion is formed in a cylindrical shape (hereinafter referred to as an in-vivo fixing portion forming member), and at least a part of which is inserted on the forming side of the in-body fixing portion. have. The cylindrical main body portion 60 </ b> A includes a distal end side holding portion 63, a proximal end side holding portion 64, and an intermediate portion 66. The “tip” refers to the insertion side into the body, and indicates the lower side in FIG. The “proximal end” refers to the opposite side of the front end and indicates the upper side in FIG.

先端側保持部63は、筒状本体部60Aの先端側に形成され、接着や係止によって体内固定部形成部材の先端部を保持する機能を有している。基端側保持部64は、筒状本体部60Aの先端側保持部63よりも基端側に形成され、外周面で体内固定部形成部材を軸方向に移動可能に保持する機能を有している。中間部66は、先端側保持部63と基端側保持部64とを接続する位置に形成されている。   The distal end side holding portion 63 is formed on the distal end side of the cylindrical main body portion 60A, and has a function of holding the distal end portion of the in-vivo fixing portion forming member by adhesion or locking. The proximal end side holding portion 64 is formed on the proximal end side with respect to the distal end side holding portion 63 of the cylindrical main body portion 60A, and has a function of holding the body fixing portion forming member so as to be movable in the axial direction on the outer peripheral surface. Yes. The intermediate portion 66 is formed at a position where the distal end side holding portion 63 and the proximal end side holding portion 64 are connected.

先端側保持部63は、径方向外側に向かって拡径し、体内固定部形成部材の先端部が当接するつば状の第1拡径部63aと、第1拡径部63aの基端側に形成され、径方向内側に向かって第1拡径部63aよりも縮径した縮径部63bと、縮径部63bの基端側に形成され、径方向外側に向かって拡径した第2拡径部63cと、を有している。このようにすれば、留置補助具60を複雑な形状にすることなく、体内固定部形成部材の先端部を容易に保持することが可能になる。   The distal-side holding portion 63 is increased in diameter toward the radially outer side, and is provided on the proximal side of the first diameter-increased portion 63a and a collar-shaped first diameter-increased portion 63a with which the distal end portion of the in-vivo fixing portion forming member abuts. A diameter-reduced portion 63b formed smaller in diameter than the first diameter-expanded portion 63a toward the radially inner side, and a second diameter-expanded portion formed on the proximal end side of the diameter-reduced portion 63b and diameter-expanded toward the radially outer side. And a diameter portion 63c. If it does in this way, it will become possible to hold easily the tip part of a body fixing part formation member, without making indwelling auxiliary tool 60 complicated.

第1拡径部63aは、先端に向かって緩やかに縮径する形状を有し、挿入/抜去時や留置時に第1拡径部63aによって瘻孔や消化管壁を傷つけにくいように構成されている。この第1拡径部63aは、体内固定部形成部材の先端部から突出した位置に配置される。なお、先端側保持部63と体内固定部形成部材とは摩擦力により係止されているが両者をより強固に保持するように、たとえば接着剤を用いて接着するとよい。   The first enlarged diameter portion 63a has a shape that gradually decreases in diameter toward the tip, and is configured so that the fistula and digestive tract wall are not easily damaged by the first enlarged diameter portion 63a during insertion / removal or indwelling. . The first enlarged diameter portion 63a is disposed at a position protruding from the distal end portion of the body fixing portion forming member. In addition, although the front end side holding | maintenance part 63 and the body fixing | fixed part formation member are latched by the frictional force, it is good to adhere | attach using an adhesive agent, for example so that both may be hold | maintained more firmly.

縮径部63bは、少なくとも一部が体内固定部形成部材の先端部の内壁と当接し、その先端部を保持固定するのに寄与している。縮径部63bは、たとえば先端側保持部63の外周に周状に形成した溝等で形成することができる。   The reduced diameter portion 63b is in contact with at least a part of the inner wall of the distal end portion of the body fixing portion forming member, and contributes to holding and fixing the distal end portion. The reduced diameter portion 63b can be formed by, for example, a groove or the like formed in a circumferential shape on the outer periphery of the distal end side holding portion 63.

第2拡径部63cは、基端に向かって緩やかに縮径する形状を有し、形成された体内固定部の形状安定化を補助する機能を有している。この第2拡径部63cは、体内固定部形成部材の内腔内における体内固定部の先端側形成部に配置される。   The second enlarged diameter portion 63c has a shape that gradually decreases in diameter toward the proximal end, and has a function of assisting the stabilization of the shape of the formed in-vivo fixed portion. The second enlarged diameter portion 63c is disposed at the distal end side forming portion of the in-vivo fixing portion within the lumen of the in-vivo fixing portion forming member.

なお、先端側保持部63の形状を図1に示すものに限定するものではない。すなわち、先端側保持部63は、体内固定部形成部材の先端部を保持する機能を有していればどのような形状でも採用することができる。たとえば、図17(a)に示すように、突出部63fを先端側保持部63の少なくとも一部に形成してもよい。この突出部63fは、チューブ10の先端部10Aの少なくとも一部を引っかけることができるようにしたものである。突出部63fは、先端側保持部63の外壁の少なくとも一部を径方向に突出させて形成するとよい。また、突出部63fを、図17(b)に示すような先端側保持部63の全周に亘って形成してもよく、図17(c)に示すような先端側保持部63の一部に形成してもよい。   In addition, the shape of the front end side holding | maintenance part 63 is not limited to what is shown in FIG. In other words, the distal-side holding portion 63 can have any shape as long as it has a function of holding the distal end portion of the body fixing portion forming member. For example, as shown in FIG. 17A, the protruding portion 63 f may be formed on at least a part of the distal end side holding portion 63. The protruding portion 63f is configured to be able to hook at least a part of the distal end portion 10A of the tube 10. The protruding portion 63f may be formed by protruding at least a part of the outer wall of the distal end side holding portion 63 in the radial direction. Further, the protruding portion 63f may be formed over the entire circumference of the tip side holding portion 63 as shown in FIG. 17B, and a part of the tip side holding portion 63 as shown in FIG. You may form in.

さらに例を挙げれば、先端側保持部63を、図18(a)に示すように径の異なる複数の段部を重ね、先端から基端に向かって段階的に拡径するような形状にしてもよい。あるいは、先端側保持部63を、図18(b)に示すように径の異なる複数の段部を重ね、先端から基端に向かって段階的に縮径するような形状にしてもよい。図18に示すような形状で先端側保持部63を形成する場合であっても、段部の少なくとも一部を径方向外側に向かって突出したものとしておき、図17に示した突出部63fと同様に機能させるようにする。   Further, as an example, the distal end side holding portion 63 is formed in a shape such that a plurality of stepped portions having different diameters are stacked as shown in FIG. 18A and the diameter gradually increases from the distal end toward the proximal end. Also good. Or you may make the front end side holding | maintenance part 63 into the shape which overlaps a some step part from which a diameter differs, as shown to FIG. Even when the tip side holding portion 63 is formed in a shape as shown in FIG. 18, it is assumed that at least a part of the stepped portion protrudes radially outward, and the protruding portion 63f shown in FIG. Make it work in the same way.

基端側保持部64は、体内固定部形成部材が軸方向に移動可能に、体内固定部形成部材の内周面を保持する。ここで、軸方向に移動可能に保持されるとは、基端側保持部64が、体内固定部形成部材の状態、すなわち伸展状態か伸展状態が解除された状態かによって、体内固定部形成部材の内周面の異なる位置と保持されることを意味する。ただし、基端側保持部64は、体内固定部形成部材が伸展された状態、つまり体内固定部が形成されていない状態においては、体内固定部形成部材の内面を保持していてもよいが、必ずしも体内固定部形成部材の内面を必ずしも保持していなくてもよい。一方、基端側保持部64は、体内固定部形成部材が圧縮された状態、つまり体内固定部が形成された状態においては、体内固定部形成部材の内面を保持していなければならない。本実施の形態では、基端側保持部64の外径は体内固定部形成部材の内径よりも大きく構成されている状態を示しており、基端側保持部64と体内固定部形成部材の内周面との間に生じる摩擦力により、体内固定部形成部材の内周面が基端側保持部64に保持されている。   The proximal end side holding portion 64 holds the inner peripheral surface of the body fixing portion forming member so that the body fixing portion forming member can move in the axial direction. Here, being held so as to be movable in the axial direction means that the proximal-side holding part 64 is in the state of the body fixing part forming member, that is, depending on whether the extended state or the extended state is released. It means that it is held at a different position on the inner peripheral surface. However, the proximal-side holding portion 64 may hold the inner surface of the body fixing portion forming member in a state where the body fixing portion forming member is extended, that is, in a state where the body fixing portion is not formed, It is not always necessary to hold the inner surface of the body fixing portion forming member. On the other hand, the proximal-side holding portion 64 must hold the inner surface of the body fixing portion forming member in a state where the body fixing portion forming member is compressed, that is, in a state where the body fixing portion is formed. In the present embodiment, the outer diameter of the proximal end holding portion 64 is configured to be larger than the inner diameter of the in-vivo fixed portion forming member, and the inner end of the proximal end holding portion 64 and the in-vivo fixed portion forming member is shown. The inner peripheral surface of the body fixing portion forming member is held by the proximal end holding portion 64 by the frictional force generated between the peripheral surface and the peripheral surface.

中間部66は、留置補助具60における先端側保持部63と基端側保持部64とを接続している部分であり、体内固定部が形成された際に、体内固定部形成部材が接触しない位置に相当している。そこで、中間部66に流体が流通可能な貫通穴67を留置補助具60の壁面の一部に貫通するように形成しておけば、栄養剤等の流通性が向上することになる。この貫通穴67は、図1に示すように、全周に亘って複数形成しておくとよい。   The intermediate portion 66 is a portion that connects the distal end side holding portion 63 and the proximal end side holding portion 64 in the indwelling auxiliary tool 60, and the in-vivo fixing portion forming member does not contact when the in-vivo fixing portion is formed. Corresponds to the position. Therefore, if the through hole 67 through which the fluid can flow in the intermediate portion 66 is formed so as to penetrate a part of the wall surface of the indwelling auxiliary tool 60, the flowability of nutrients and the like is improved. As shown in FIG. 1, a plurality of through holes 67 may be formed over the entire circumference.

図1(b)に示すように、留置補助具60の内周面には、径方向内側に向かって突出する内部突起65を設けるとよい。内部突起65は、後述する伸展具の先端部と係合する機能を有する。なお、ここでは、内部突起65が形成されている状態を例に示しているが、留置補助具60に挿入される伸展具の先端部によって係止できるのであれば必ずしも設けなくてもよい。   As shown in FIG. 1B, an inner protrusion 65 that protrudes radially inward may be provided on the inner peripheral surface of the indwelling auxiliary tool 60. The internal protrusion 65 has a function of engaging with a distal end portion of an extender described later. Here, the state in which the internal protrusion 65 is formed is shown as an example, but it is not necessarily provided as long as it can be locked by the distal end portion of the extender inserted into the indwelling auxiliary tool 60.

以上のように構成された留置補助具60を用いれば、体内固定部形成部材は、先端部が先端側保持部63で、体内固定部の形成位置よりも基端側が基端側保持部64で、それぞれ保持されることになる。したがって、留置補助具60は、動きが激しく、内容物(流動食や栄養剤等を含む)や体液に晒される消化管壁内においても、形成された体内固定部の軸方向の他端側を基端側保持部64で保持した状態において先端側保持部63及び基端側保持部64の外周面が内容物や体液に晒されることがない。そのため、体内固定部の形状がより保たれやすくなり、瘻孔カテーテルの留置状態を良好に保つことができ、自己抜去等の意図しない抜去を抑制することができる。   By using the indwelling auxiliary tool 60 configured as described above, the distal end portion of the in-vivo fixing portion forming member is the distal end side holding portion 63 and the proximal end side from the formation position of the in vivo fixing portion is the proximal end side holding portion 64. , Each will be held. Therefore, the indwelling auxiliary tool 60 moves rapidly, and the other end side in the axial direction of the formed in-vivo fixed part is also formed in the digestive tract wall exposed to contents (including liquid foods, nutrients, etc.) and body fluids. The outer peripheral surfaces of the distal end side holding portion 63 and the proximal end side holding portion 64 are not exposed to the contents or body fluid in a state where they are held by the proximal end side holding portion 64. Therefore, the shape of the in-vivo fixing part can be more easily maintained, the indwelling state of the fistula catheter can be maintained well, and unintentional removal such as self-extraction can be suppressed.

また、留置補助具60が体内固定部形成部材に挿入されると、留置補助具60の外周面が体内固定部形成部材の内腔に密着することになる。このため、留置補助具60と体内固定部形成部材との間に胃液や栄養液が入りにくくなり、留置補助具60と体内固定部形成部材との接触面の劣化を抑制することができる。また、留置補助具60が栄養剤等によって滑って外れてしまう等のトラブルが起きにくくなる。その結果、留置補助具60と体内固定部形成部材との密着状態が安定的に保たれ、体内固定部の形状が維持されることになる。   Further, when the indwelling auxiliary tool 60 is inserted into the in-vivo fixing part forming member, the outer peripheral surface of the indwelling auxiliary tool 60 comes into close contact with the lumen of the in-vivo fixing part forming member. For this reason, it becomes difficult for gastric juice and nutrient solution to enter between the indwelling auxiliary tool 60 and the in-vivo fixing part forming member, and the deterioration of the contact surface between the indwelling auxiliary tool 60 and the in-vivo fixing part forming member can be suppressed. In addition, troubles such as the indwelling aid 60 slipping off due to a nutrient or the like are less likely to occur. As a result, the intimate contact between the indwelling auxiliary tool 60 and the in-vivo fixing portion forming member is stably maintained, and the shape of the in-vivo fixing portion is maintained.

図2は、実施の形態に係る留置補助具60を用いた瘻孔カテーテル1の要部模式図である。図3は、実施の形態に係る瘻孔カテーテル1の体内固定部Bを伸展させる動作を断面で示す模式図である。図4は、瘻孔カテーテル1の斜視図である。図5は、瘻孔カテーテル1の側面図である。図6は、瘻孔カテーテル1の平面図である。図7は、瘻孔カテーテル1の底面図である。図8は、瘻孔カテーテル1の伸展状態を示す側面模式図である。図9は、図8のA−A矢視断面模式図である。図10は、瘻孔カテーテル1の挿入/抜去動作を説明する図である。図11は、瘻孔カテーテル1の留置状態を説明する図である。図2〜図11に基づいて、留置補助具60を用いた瘻孔カテーテル1について詳しく説明する。   FIG. 2 is a schematic diagram of a main part of the fistula catheter 1 using the indwelling auxiliary tool 60 according to the embodiment. FIG. 3 is a schematic diagram showing in cross section the operation of extending the in-vivo fixation part B of the fistula catheter 1 according to the embodiment. FIG. 4 is a perspective view of the fistula catheter 1. FIG. 5 is a side view of the fistula catheter 1. FIG. 6 is a plan view of the fistula catheter 1. FIG. 7 is a bottom view of the fistula catheter 1. FIG. 8 is a schematic side view showing a stretched state of the fistula catheter 1. 9 is a schematic cross-sectional view taken along the line AA in FIG. FIG. 10 is a diagram for explaining the insertion / extraction operation of the fistula catheter 1. FIG. 11 is a diagram for explaining the indwelling state of the fistula catheter 1. The fistula catheter 1 using the indwelling auxiliary tool 60 will be described in detail based on FIGS.

図10に示すように、瘻孔カテーテル1は、患者の腹壁71と消化管壁72とを貫通するように形成された瘻孔73に装着されるものである。この瘻孔カテーテル1は、図2に示すように、カテーテル部Aと体内固定部Bとを備えている。カテーテル部Aは、瘻孔73に挿入され、栄養剤等の流体を通過させる機能を有する。体内固定部Bは、瘻孔カテーテル1が患者の瘻孔73に留置されたときに胃壁等の消化管壁72内に位置し、瘻孔カテーテル1が患者の瘻孔73から抜けるのを抑制する機能を有する。そして、瘻孔カテーテル1は、上述した留置補助具60を備えている。なお、ここでは、体内固定部形成部材としてチューブを用いた場合を例に挙げて説明する。   As shown in FIG. 10, the fistula catheter 1 is attached to a fistula 73 formed so as to penetrate the patient's abdominal wall 71 and digestive tract wall 72. As shown in FIG. 2, the fistula catheter 1 includes a catheter part A and a body fixing part B. The catheter part A is inserted into the fistula 73 and has a function of allowing fluid such as nutrients to pass through. The internal fixation part B is located in the digestive tract wall 72 such as the stomach wall when the fistula catheter 1 is placed in the patient's fistula 73, and has a function of suppressing the fistula catheter 1 from coming out of the patient's fistula 73. The fistula catheter 1 includes the indwelling auxiliary tool 60 described above. Here, a case where a tube is used as the in-vivo fixing portion forming member will be described as an example.

なお、以降の説明において、「近位」とは、瘻孔73に設置された状態における瘻孔カテーテル1のカテーテル部Aの端部側をいい、図2における図面上側を示す。また、「遠位」とは近位の反対側をいい、図2における図面下側を示す。   In the following description, “proximal” means the end side of the catheter part A of the fistula catheter 1 in a state where it is installed in the fistula 73, and indicates the upper side of the drawing in FIG. Further, "distal" refers to the opposite side of the proximal side, and shows the lower side of the drawing in FIG.

瘻孔カテーテル1は、チューブ10を備えている。チューブ10は、例えばポリウレタン樹脂、ポリ塩化ビニル樹脂、シリコーン樹脂等の樹脂材料で構成され、内部に栄養剤等の流体物を通過させるための内腔を有している。チューブ10の材料を上記材料に限定するものではないが、熱賦形が可能であり、熱賦形後においても可撓性を有する材料を用いる。   The fistula catheter 1 includes a tube 10. The tube 10 is made of, for example, a resin material such as polyurethane resin, polyvinyl chloride resin, or silicone resin, and has a lumen for allowing fluids such as nutrients to pass therethrough. Although the material of the tube 10 is not limited to the above-mentioned material, heat shaping is possible, and a material having flexibility even after heat shaping is used.

図8及び図9に示すように、チューブ10には、チューブ内外を連通する複数のスリット11が軸方向に沿って設けられている。本実施の形態では、スリット11の本数が3本である場合を例に示している。スリット11の長さは、特に限定するものではなく、体内固定部Bの形状や大きさ等に応じて決定すればよい。スリット11は、チューブの軸方向に平行に設けることができるが、軸方向に対して斜めに設けてもよい。また、本実施の形態では、3本の各スリット11は、チューブ10の周壁をほぼ三等分する位置に設けられている。   As shown in FIGS. 8 and 9, the tube 10 is provided with a plurality of slits 11 communicating with the inside and outside of the tube along the axial direction. In the present embodiment, a case where the number of slits 11 is three is shown as an example. The length of the slit 11 is not particularly limited, and may be determined according to the shape and size of the in-vivo fixed part B. The slit 11 can be provided parallel to the axial direction of the tube, but may be provided obliquely with respect to the axial direction. In the present embodiment, each of the three slits 11 is provided at a position that divides the peripheral wall of the tube 10 into approximately three equal parts.

このスリット11によりチューブ10の周壁が複数に分割され、分割されたことによりそれぞれ3つのベルト12が形成されている。各ベルト12はその上端部及び下端部においてチューブの周壁として一つにつながった状態である。そして、ベルト12の遠位端側と近位端側とを軸方向に近づけるようにして、チューブ10の遠位端が近位端側に向かって押されると、ベルト12がその弾性により曲がり、図2、図3に示すような翼部13が形成される。   The slit 11 divides the peripheral wall of the tube 10 into a plurality of parts, and three belts 12 are formed by the division. Each belt 12 is in a state of being connected together as a peripheral wall of the tube at its upper end and lower end. When the distal end of the tube 10 is pushed toward the proximal end side so that the distal end side and the proximal end side of the belt 12 are close to each other in the axial direction, the belt 12 bends due to its elasticity, The wing part 13 as shown in FIGS. 2 and 3 is formed.

図2に示すように、チューブ10は、3つの翼部13を備えている。翼部13は、チューブ10の近位端側から径方向外側に向かって延び、さらにこれと反対方向に屈曲する屈曲部16を有し、この屈曲部16に連続して径方向内側に向かって延びる形状を有している。なお、翼部13の形状を特に限定するものではなく、チューブ等の体内固定部形成部材の有する弾性によって変形可能な形状であればよい。なお、屈曲部16は、断面が略U字形状となるような弧を描くように屈曲しているが、これに限定するものではなく、鋭角に屈曲してもよい。   As shown in FIG. 2, the tube 10 includes three wing parts 13. The wing portion 13 has a bent portion 16 that extends radially outward from the proximal end side of the tube 10 and bends in the opposite direction, and continues to the bent portion 16 toward the radially inner side. It has an extending shape. In addition, the shape of the wing | blade part 13 is not specifically limited, What is necessary is just a shape which can be deform | transformed with the elasticity which the body fixing | fixed part formation member, such as a tube, has. The bent portion 16 is bent so as to draw an arc having a substantially U-shaped cross section, but is not limited to this and may be bent at an acute angle.

図8に示す状態のチューブ10の遠位端を、近位端側に近づけるようにして押し、ベルト12を径方向外側に向かって屈曲させることで、翼部13を形成する。そうすると、図2〜図7に示すような形状の体内固定部Bが形成されるので、この状態で熱賦形することにより、瘻孔カテーテル1が作製されている。ここでは、チューブ10の熱賦形によって体内固定部Bの形状が決定されている場合を例に説明するが、これに限定するものではない。すなわち、留置補助具60を用いれば、留置補助具60によって体内固定部Bの形状を保持することが可能になるので、体内固定部Bの形状を熱賦形によって予め決定しておく必要はない。   The wing portion 13 is formed by pushing the distal end of the tube 10 in the state shown in FIG. 8 so as to approach the proximal end side and bending the belt 12 radially outward. Then, since the in-vivo fixing part B having a shape as shown in FIGS. 2 to 7 is formed, the fistula catheter 1 is manufactured by heat-shaping in this state. Here, although the case where the shape of the in-vivo fixed part B is determined by the heat shaping of the tube 10 is described as an example, it is not limited to this. That is, if the indwelling auxiliary tool 60 is used, the indwelling auxiliary tool 60 can hold the shape of the in-vivo fixed part B, and therefore the shape of the in-vivo fixed part B need not be determined in advance by heat shaping. .

チューブ10は、熱賦形後においても可撓性を有する材料で構成されている。したがって、チューブ10の遠位端15を、近位端14側から軸方向に離すことで、チューブ10は、ほぼまっすぐに伸びた伸展状態となる(図8参照)。そして、この伸展状態を解除すると、再び図2に示すよう翼部13が形成された状態となる。なお、上記したように、熱賦形していないチューブ10を使用していれば、伸展状態を解除しても、翼部13が形成された状態には戻らない。この場合は、後述する伸展具50を用いて留置補助具60を手前側に引き寄せて翼部13を形成し、基端側保持部64で体内固定部Bの軸方向の他端側を保持することで、体内固定部Bが形成されることになる。   The tube 10 is made of a material having flexibility even after heat forming. Therefore, by separating the distal end 15 of the tube 10 from the proximal end 14 side in the axial direction, the tube 10 is in an extended state extending substantially straight (see FIG. 8). Then, when the extended state is released, the wing part 13 is formed again as shown in FIG. As described above, if the tube 10 that is not heat-shaped is used, even if the extended state is canceled, the wing portion 13 is not returned to the formed state. In this case, the indwelling auxiliary tool 60 is pulled toward the front side by using the extension tool 50 described later to form the wing part 13, and the proximal end side holding part 64 holds the other end side in the axial direction of the body fixing part B. As a result, the in-vivo fixing part B is formed.

留置補助具60は、上述したように、チューブ10の一部が弾性変形することで形成される体内固定部Bの形状の安定化に寄与するものである。すなわち、留置補助具60の先端側保持部63が接着や係止によってチューブ10の先端部10A(先端面10a及び先端部内周面10b)を保持し、留置補助具60の基端側保持部64が外周面で翼部13の開始端P(図3参照)よりも近位端側の内周面を保持する。これにより、先端側保持部63と基端側保持部64とが、チューブ10の近位端と遠位端とが近づくことにより形成される翼部13の状態を維持させるようになっている。   As described above, the indwelling auxiliary tool 60 contributes to stabilization of the shape of the in-vivo fixing part B formed by elastic deformation of a part of the tube 10. That is, the distal end side holding portion 63 of the placement assisting tool 60 holds the distal end portion 10A (the distal end surface 10a and the distal end portion inner peripheral surface 10b) of the tube 10 by adhesion or locking, and the proximal end side retaining portion 64 of the placement assisting tool 60. However, the outer peripheral surface holds the inner peripheral surface closer to the proximal end side than the start end P (see FIG. 3) of the wing part 13. Thereby, the front end side holding | maintenance part 63 and the base end side holding | maintenance part 64 maintain the state of the wing | blade part 13 formed when the proximal end and distal end of the tube 10 approach.

したがって、チューブ10は、先端部10Aが先端側保持部63で、体内固定部Bの形成位置よりも基端側が基端側保持部64で、それぞれ保持されるようになっている。したがって、動きが激しく内容物や体液に晒される消化管壁72内においても、体内固定部Bの形状がより保たれやすくなる。このため、瘻孔カテーテル1の留置状態を良好に保つことができ、自己抜去等の意図しない抜去を抑制することができる。   Accordingly, the tube 10 is held at the distal end side holding portion 63 at the distal end portion 10A and at the proximal end holding portion 64 at the proximal end side relative to the position where the in-vivo fixing portion B is formed. Therefore, the shape of the in-vivo fixed part B can be more easily maintained even in the digestive tract wall 72 exposed to contents and body fluids that are intensely moved. For this reason, the indwelling state of the fistula catheter 1 can be maintained well, and unintentional removal such as self-extraction can be suppressed.

また、留置補助具60がチューブ10に挿入されると、留置補助具60の外周面がチューブ10の内腔に密着することになる。このため、留置補助具60とチューブ10との間に胃液や栄養液が入りにくくなり、留置補助具60とチューブ10との接触面の劣化を抑制することができる。また、留置補助具60が栄養剤等によって滑って外れてしまう等のトラブルが起きにくくなる。その結果、留置補助具60とチューブ10との密着状態が安定的に保たれ、体内固定部Bの形状が維持されることになる。   Further, when the indwelling auxiliary tool 60 is inserted into the tube 10, the outer peripheral surface of the indwelling auxiliary tool 60 comes into close contact with the lumen of the tube 10. For this reason, it becomes difficult for gastric juice and nutrient solution to enter between the indwelling aid 60 and the tube 10, and deterioration of the contact surface between the indwelling aid 60 and the tube 10 can be suppressed. In addition, troubles such as the indwelling aid 60 slipping off due to a nutrient or the like are less likely to occur. As a result, the close contact state between the indwelling auxiliary tool 60 and the tube 10 is stably maintained, and the shape of the in-vivo fixing part B is maintained.

次に、このように構成された瘻孔カテーテル1の瘻孔73への留置動作について説明する。まず、瘻孔カテーテル1の体内固定部Bを伸展させ、この体内固定部Bを胃壁や腸壁等の消化管壁72内に挿入するために用いる伸展具50について説明する。   Next, an indwelling operation of the thus configured fistula catheter 1 in the fistula 73 will be described. First, the extension device 50 used for extending the body fixing part B of the fistula catheter 1 and inserting the body fixing part B into the digestive tract wall 72 such as the stomach wall or the intestinal wall will be described.

図10に示すように、伸展具50は、先端側に設けられた係合部51と、係合部51とは反対側の端部に設けられた操作部52と、操作部52と係合部51との間に設けられた軸部53とを有する。係合部51及び軸部53は、チューブ10の内腔に挿入可能に構成されている。特に、係合部51は、留置補助具60の内腔に挿入可能になっている。操作部52は、例えば合成樹脂や金属で構成されており、術者が指をかけることができるような形状を有している。   As shown in FIG. 10, the extender 50 includes an engagement portion 51 provided on the distal end side, an operation portion 52 provided on the end opposite to the engagement portion 51, and an engagement with the operation portion 52. And a shaft portion 53 provided between the portion 51. The engaging portion 51 and the shaft portion 53 are configured to be insertable into the lumen of the tube 10. In particular, the engaging portion 51 can be inserted into the lumen of the indwelling auxiliary tool 60. The operation unit 52 is made of, for example, synthetic resin or metal, and has a shape that allows the operator to place a finger.

係合部51は、留置補助具60の内腔に形成されている内部突起65の内径と同じか、それよりも大きな径となるよう構成されている。また係合部51の軸方向の長さは、留置補助具60の内腔に形成されている内部突起65の長さに応じて決定すればよい。なお、内部突起65が形成されていない留置補助具60を用いる場合、留置補助具60の内腔自体で係合部51と係止するようにしてもよい。この場合、係合部51は、留置補助具60の内径よりも大きな径となるように構成するとよい。    The engaging portion 51 is configured to have a diameter that is the same as or larger than the inner diameter of the internal protrusion 65 formed in the inner cavity of the indwelling auxiliary tool 60. The axial length of the engaging portion 51 may be determined according to the length of the internal protrusion 65 formed in the lumen of the indwelling auxiliary tool 60. In addition, when using the indwelling auxiliary tool 60 in which the internal protrusion 65 is not formed, you may make it latch with the engaging part 51 by the lumen | bore itself of the indwelling auxiliary tool 60. FIG. In this case, the engaging portion 51 may be configured to have a diameter larger than the inner diameter of the indwelling auxiliary tool 60.

このように構成された係合部51を、伸展させた状態のチューブ10の内腔内に位置させる。留置補助具60の内腔には内部突起65が設けられているので、伸展具50の係合部51は内部突起65に係止される。このようにすると、係合部51の外面と内部突起65の内周面とが密着し、係合部51の外面とチューブ10の内周面とに生じる摩擦力により、チューブ10の伸展状態が保持される。なお、ここで説明した伸展具50の構成は伸展具としての一例であり、その形状や瘻孔カテーテル1を伸展させるための構造を限定するものではない。   The engaging portion 51 configured as described above is positioned in the lumen of the tube 10 in the extended state. Since the inner protrusion 65 is provided in the lumen of the indwelling auxiliary tool 60, the engaging portion 51 of the extension tool 50 is locked to the inner protrusion 65. In this way, the outer surface of the engaging portion 51 and the inner peripheral surface of the inner protrusion 65 are in close contact with each other, and the extension state of the tube 10 is caused by the frictional force generated between the outer surface of the engaging portion 51 and the inner peripheral surface of the tube 10. Retained. In addition, the structure of the extension tool 50 demonstrated here is an example as an extension tool, and the structure for extending the fistula catheter 1 is not limited.

次に、図3(a)〜図3(c)を参照して、瘻孔カテーテル1の伸展動作を説明する。なお、図3では、先端側保持部63とチューブ10との保持部分、及び、基端側保持部64とチューブ10との保持部分を太線で強調して図示している。なお、図3では、チューブ10の伸展状態において基端側保持部64がチューブ10の内周面に当接されている状態を例に示しているが、これに限定するものではなく、スリット11の設置部分における長さによっては、チューブ10の伸展状態において基端側保持部64がチューブ10の内周面に当接されている必要はない。つまり、基端側保持部64は体内固定部Bが形成された際にチューブ10の内周面を保持できればよいのである。   Next, the extension operation of the fistula catheter 1 will be described with reference to FIGS. 3 (a) to 3 (c). In FIG. 3, the holding portion between the distal end side holding portion 63 and the tube 10 and the holding portion between the proximal end side holding portion 64 and the tube 10 are illustrated with bold lines. 3 shows an example in which the proximal end side holding portion 64 is in contact with the inner peripheral surface of the tube 10 in the extended state of the tube 10, but the present invention is not limited to this, and the slit 11 Depending on the length of the installed portion of the tube 10, the proximal end holding portion 64 does not need to be in contact with the inner peripheral surface of the tube 10 in the extended state of the tube 10. That is, the proximal end side holding portion 64 only needs to hold the inner peripheral surface of the tube 10 when the in-vivo fixing portion B is formed.

図3(a)に示すように、瘻孔カテーテル1のチューブ10には翼部13が形成された状態であるものとする。このような状態で、伸展具50をチューブ10及び留置補助具60の内腔に挿入する。伸展具50は、留置補助具60の内周面と着脱可能に固定される係合部51を有している。ここでは、留置補助具60に設けられた内部突起65の内周面と、係合部51の外周面との間に生じる摩擦力により、両者が固定される構成となっている。すなわち、伸展具50を留置補助具60内の適当な位置まで挿入すると、係合部51と留置補助具60の内部突起65との間に摩擦力が働き、留置補助具60内における伸展具50の進行が停止される。   As shown in FIG. 3A, it is assumed that the wing portion 13 is formed on the tube 10 of the fistula catheter 1. In this state, the extender 50 is inserted into the lumens of the tube 10 and the placement aid 60. The extension tool 50 has an engaging portion 51 that is detachably fixed to the inner peripheral surface of the indwelling auxiliary tool 60. Here, both are fixed by the frictional force generated between the inner peripheral surface of the internal protrusion 65 provided in the indwelling auxiliary tool 60 and the outer peripheral surface of the engaging portion 51. That is, when the extender 50 is inserted to an appropriate position in the indwelling auxiliary tool 60, a frictional force acts between the engaging portion 51 and the internal protrusion 65 of the indwelling auxiliary tool 60, and the extender 50 in the indwelling auxiliary tool 60. Progress is stopped.

この状態で伸展具50がさらに押し込まれることにより、基端側保持部64におけるチューブ10内周面との摩擦力を超える力が加えられると、両者の固定はいったん解除される。そうすると、図3(b)に示すように、伸展具50の係合部51と係合された留置補助具60は、伸展具50に伴って遠位端側に進む。そして、この留置補助具60と先端側保持部63により固定されたチューブ10の先端部10Aもまた遠位端側に進むこととなる。このようにして、伸展具50を押し込むことで、チューブ10の翼部13が伸び、図3(c)のような状態となる。このような動作を実現するため、係合部51と留置補助具60の内部突起65との間に生じる摩擦力は、基端側保持部64とチューブ10内周面との間に生じる摩擦力よりも大きくなるよう構成されている。このようにすることで、瘻孔カテーテル1は伸展状態となり、瘻孔73への挿入/抜去が可能となる。   When the extension tool 50 is further pushed in this state and a force exceeding the frictional force with the inner peripheral surface of the tube 10 at the proximal end side holding portion 64 is applied, the fixation of both is once released. Then, as shown in FIG. 3 (b), the indwelling auxiliary tool 60 engaged with the engaging portion 51 of the extension tool 50 advances to the distal end side along with the extension tool 50. Then, the distal end portion 10A of the tube 10 fixed by the indwelling auxiliary tool 60 and the distal end side holding portion 63 also advances to the distal end side. Thus, by pushing in the extension tool 50, the wing | blade part 13 of the tube 10 is extended, and it will be in a state like FIG.3 (c). In order to realize such an operation, the frictional force generated between the engaging portion 51 and the internal protrusion 65 of the indwelling auxiliary tool 60 is the frictional force generated between the proximal end holding portion 64 and the inner peripheral surface of the tube 10. It is comprised so that it may become larger. By doing so, the fistula catheter 1 is in an extended state, and can be inserted / removed into / from the fistula 73.

このように、本実施の形態によれば、チューブ10内に挿入される留置補助具60を備えた。この留置補助具60は、チューブ10のスリット11の近位端側端部よりも近位端側におけるチューブ10の内周面に軸方向に移動可能にチューブ10を保持する基端側保持部64を備え、チューブ10のスリット11の遠位端側端部よりも遠位端側におけるチューブ10を保持する先端側保持部63を備えている。翼部13が形成された状態で、基端側保持部64と先端側保持部63がチューブ10と保持されることで、翼部13の形状を維持することができる。このため、動きが激しく内容物や体液に晒される消化管壁72内においても、体内固定部Bの形状がより保たれやすくなる。したがって、瘻孔カテーテル1の留置状態を良好に保つことができ、自己抜去等の意図しない抜去を抑制することができる。   Thus, according to this Embodiment, the indwelling auxiliary tool 60 inserted in the tube 10 was provided. This indwelling auxiliary tool 60 has a proximal end side holding portion 64 that holds the tube 10 so as to be movable in the axial direction on the inner peripheral surface of the tube 10 on the proximal end side of the proximal end side of the slit 11 of the tube 10. And a distal end side holding portion 63 that holds the tube 10 on the distal end side with respect to the distal end side end portion of the slit 11 of the tube 10. The base end side holding portion 64 and the distal end side holding portion 63 are held with the tube 10 in a state where the wing portion 13 is formed, so that the shape of the wing portion 13 can be maintained. For this reason, the shape of the in-vivo fixed part B can be more easily maintained even in the digestive tract wall 72 exposed to contents and body fluids that are intensely moved. Therefore, the indwelling state of the fistula catheter 1 can be kept good, and unintentional removal such as self-extraction can be suppressed.

なお、留置補助具60と伸展具50との着脱可能な固定構造は、上記した係合部51と内部突起65による摩擦力を利用したものに限定されず、瘻孔カテーテル1の翼部13を伸展させるべく伸展具50を押し込んだときに伸展具50と留置補助具60とを固定可能であって、留置補助具60によって体内固定部Bとして機能する形状を形成した後に、両者が離れる構成であればよい。例えば、留置補助具60の内周面と伸展具50の先端近傍の外周面に互いに螺合するネジを設けてもよい。   Note that the detachable fixing structure between the indwelling auxiliary tool 60 and the extension tool 50 is not limited to the structure using the frictional force generated by the engaging part 51 and the internal protrusion 65, and the wing part 13 of the fistula catheter 1 is extended. The extension tool 50 and the indwelling auxiliary tool 60 can be fixed when the extension tool 50 is pushed in, and after the shape that functions as the in-body fixing part B is formed by the indwelling auxiliary tool 60, both are separated. That's fine. For example, you may provide the screw screwed together by the inner peripheral surface of the indwelling auxiliary tool 60, and the outer peripheral surface of the extension tool 50 near the front-end | tip.

次に、このように構成された瘻孔カテーテル1の瘻孔73への留置動作について説明する。図10に示すように、伸展具50により伸展された状態の瘻孔カテーテル1を、腹壁71と消化管壁72とに形成された瘻孔73に挿入する。瘻孔カテーテル1の径は、最大でも留置補助具60が挿入されている状態のチューブ10の径と同じであり、瘻孔73を通過する際の抵抗が低い。このため、瘻孔73を傷つけるリスクが少ない。   Next, an indwelling operation of the thus configured fistula catheter 1 in the fistula 73 will be described. As shown in FIG. 10, the fistula catheter 1 that has been extended by the extension tool 50 is inserted into a fistula 73 formed in the abdominal wall 71 and the digestive tract wall 72. The diameter of the fistula catheter 1 is the same as the diameter of the tube 10 in a state where the indwelling auxiliary tool 60 is inserted at the maximum, and the resistance when passing through the fistula 73 is low. For this reason, there is little risk of damaging the fistula 73.

そして、適度な挿入深度となったところで、カテーテル部Aが抜けないように腹壁71側に押さえつつ、術者が伸展具50を手前側に引っ張る。係合部51と内部突起65との摩擦力を超える力で引っ張ることで、係合部51と留置補助具60との密着状態が解除され、伸展具50がチューブ10内から引き抜かれる。瘻孔カテーテル1は、熱賦形されているため、伸展具50が引き抜かれて伸展状態が解除されると、図11に示すように体内固定部Bが形成された状態になる。伸展具50を引き抜くだけで、伸展状態の瘻孔カテーテル1を体内固定部Bが形成された状態にすることができ、手技が簡便である。   When the insertion depth is appropriate, the surgeon pulls the extension device 50 toward the front side while pressing the abdominal wall 71 so that the catheter part A does not come out. By pulling with a force exceeding the frictional force between the engaging portion 51 and the internal protrusion 65, the close contact state between the engaging portion 51 and the indwelling auxiliary tool 60 is released, and the extender 50 is pulled out from the tube 10. Since the fistula catheter 1 is heat-shaped, when the extender 50 is pulled out and the extended state is released, the in-vivo fixed part B is formed as shown in FIG. By simply pulling out the extender 50, the stretched fistula catheter 1 can be brought into a state where the in-vivo fixing part B is formed, and the procedure is simple.

なお、上述したように、熱賦形されていないチューブ10を用いた場合には、留置補助具60が係合されている状態の伸展具50を手前側に引っ張り、留置補助具60の基端側保持部64の外周面で体内固定部Bの軸方向の他端側を保持させ、留置補助具60によって体内固定部Bとして機能する形状にした後、伸展具50と留置補助具60との密着状態を解除して伸展具50を引き抜けばよい。この場合でも、操作としては伸展具50を引き抜くだけであるので、簡便な手技で体内固定部Bが形成された状態にすることができる。   As described above, when the tube 10 that is not heat-shaped is used, the extension device 50 in a state in which the indwelling auxiliary tool 60 is engaged is pulled to the near side, and the proximal end of the indwelling auxiliary device 60 After the other end side in the axial direction of the in-vivo fixing part B is held on the outer peripheral surface of the side holding part 64 and formed into a shape that functions as the in-vivo fixing part B by the indwelling auxiliary tool 60, the extension tool 50 and the indwelling auxiliary tool 60 It is only necessary to release the contact state and pull out the extender 50. Even in this case, since only the extension tool 50 is pulled out as an operation, the body fixing part B can be formed with a simple technique.

瘻孔73に留置されたカテーテルのカテーテル部Aの近位端は、体外に露出した状態である。この露出したカテーテル部の近位端に、任意の体外固定部を接続する。体外固定部としては、ボタン型のカテーテルのようにチューブの端部に固定されたタイプ、あるいはチューブ型のカテーテルのようにチューブに体外固定部を脱着可能に取り付けるタイプがあるがいずれであってもよい。また、体外固定部との接続構造も任意のものを用いることができる。   The proximal end of the catheter part A of the catheter placed in the fistula 73 is exposed outside the body. An optional extracorporeal fixation portion is connected to the exposed proximal end of the catheter portion. As the extracorporeal fixing part, there is a type that is fixed to the end of the tube like a button type catheter, or a type that attaches the extracorporeal fixing part to the tube so as to be detachable like a tube type catheter. Good. Also, any connection structure with the extracorporeal fixing part can be used.

図11に示すように、体内固定部Bが形成された状態となり消化管壁内に留置された瘻孔カテーテル1は、翼部13の上面(近位端側の面)が消化管壁に接触する。図6に示すように、翼部13の中心部(すなわち、チューブ10の外周面近傍)には、チューブ10の翼部13でほぼ円形の面Sが形成される。この面Sが、消化管壁72の瘻孔73の周囲に当接する。面Sで消化管壁72に接触するので、消化管壁72に対する侵襲が少ない。また、翼部13を、消化管壁72に対して丸みを帯びた形状としておけば、消化管壁72に対する当たりがやわらかく、消化管壁72への侵襲を更に低減できる。   As shown in FIG. 11, the fistula catheter 1 placed in the digestive tract wall with the in-vivo fixation part B formed is in contact with the digestive tract wall on the upper surface (proximal end side surface) of the wing part 13. . As shown in FIG. 6, a substantially circular surface S is formed by the wing portion 13 of the tube 10 at the center portion of the wing portion 13 (that is, near the outer peripheral surface of the tube 10). This surface S abuts around the fistula 73 of the digestive tract wall 72. Since the surface S contacts the digestive tract wall 72, there is little invasion to the digestive tract wall 72. Further, if the wing part 13 is formed in a rounded shape with respect to the digestive tract wall 72, the contact with the digestive tract wall 72 is soft, and the invasion to the digestive tract wall 72 can be further reduced.

また、例えば腹壁71側から瘻孔カテーテル1が引っ張られた場合、翼部13の上面が消化管壁72に押し当てられ、放射状に広がった状態のチューブ10の翼部13には、閉じようとする方向に力が働く。すなわち、チューブ10の翼部13は、屈曲部16が径方向内側に移動して翼部13の外径が小さくなろうとする。しかし、留置補助具60により体内固定部Bの形状が維持され、自己抜去等の意図しない瘻孔カテーテル1の抜去を抑制することができる。   Further, for example, when the fistula catheter 1 is pulled from the abdominal wall 71 side, the upper surface of the wing part 13 is pressed against the digestive tract wall 72 and tries to close the wing part 13 of the tube 10 in a radially expanded state. Power works in the direction. That is, in the wing part 13 of the tube 10, the bent part 16 moves inward in the radial direction and the outer diameter of the wing part 13 tends to be reduced. However, the shape of the in-vivo fixed part B is maintained by the indwelling auxiliary tool 60, and unintentional removal of the fistula catheter 1 such as self-extraction can be suppressed.

なお、留置状態の瘻孔カテーテル1を瘻孔73から抜去する際には、挿入時と同様の手技により瘻孔カテーテル1の体内固定部を伸展させた状態にして引き抜けばよい。   When the fistula catheter 1 in the indwelling state is removed from the fistula 73, the in-vivo fixed part of the fistula catheter 1 may be extended by the same procedure as that for insertion.

このように、本実施の形態によれば、劣化しにくい材料で構成された留置補助具60を用いて、消化管壁72内におけるチューブ等の体内固定部形成部材との保持状態が解除されにくく、その結果、体内固定部Bの形状を長期間、安定的に維持することが可能になる。そのため、体内固定部Bが変形してしまうことによる消化管壁への侵襲をより低減できる。したがって、体内固定部Bの形状を長期間、安定的に維持することができ、自己抜去等の意図しない抜去を抑制することもできる。   Thus, according to the present embodiment, using the indwelling auxiliary tool 60 made of a material that does not easily deteriorate, the holding state with the body fixing portion forming member such as a tube in the digestive tract wall 72 is difficult to be released. As a result, the shape of the in-vivo fixed part B can be stably maintained for a long period of time. Therefore, the invasion to the digestive tract wall due to the deformation of the in-vivo fixed part B can be further reduced. Therefore, the shape of the in-vivo fixed part B can be stably maintained for a long period of time, and unintentional extraction such as self-extraction can be suppressed.

また、瘻孔カテーテル1は、伸展状態においてその外径はチューブ10の外径(第1拡径部63aで若干大きくなっている外径)である。このため、一般的な合成樹脂製の消化管壁内において拡径するよう構成されたバンパーと比較して、伸展時における外径が小さい。したがって、挿入/抜去時における瘻孔に対する抵抗が少なく、瘻孔73を傷つけるリスクを低減できる。また、瘻孔カテーテル1は、チューブ10と留置補助具60という2つの部材で構成されており、部品点数が少ない。このため、製造コストの増加を抑制できる。さらに、瘻孔カテーテル1は、遠位端側と近位端側とを引き離すことで容易に伸展状態となるので、挿入/抜去時の手技が容易であり、術者の負担を軽減できる。   In addition, the fistula catheter 1 has an outer diameter that is the outer diameter of the tube 10 (the outer diameter that is slightly larger at the first expanded portion 63a) in the extended state. For this reason, the outer diameter at the time of extension is small compared with the bumper comprised so that it may expand in the digestive tract wall made from a general synthetic resin. Therefore, there is little resistance to the fistula at the time of insertion / extraction, and the risk of damaging the fistula 73 can be reduced. Further, the fistula catheter 1 is composed of two members, the tube 10 and the indwelling auxiliary tool 60, and has a small number of parts. For this reason, the increase in manufacturing cost can be suppressed. Furthermore, since the fistula catheter 1 is easily extended by separating the distal end side and the proximal end side from each other, the procedure at the time of insertion / extraction is easy, and the burden on the operator can be reduced.

なお、上記実施の形態で述べた構成のほか、以下のような応用も可能である。スリット11の数は、上記説明ではチューブ10に3本としたが、2本以上の任意の数とすることができる。また、スリット11は、それぞれ、チューブ10の周壁を径方向に三等分する位置に設けた例を示したが、三等分ではない位置に設けてもよい。上記説明では、チューブ10にベルト12を形成するためにスリット11を設けた例を示した。このスリットは、チューブ10に細い隙間を形成するものであるが、このようなスリットではなく、切れ目を設けてもよい。   In addition to the configuration described in the above embodiment, the following applications are also possible. The number of the slits 11 is three in the tube 10 in the above description, but can be any number of two or more. Moreover, although the slit 11 was shown in the example which provided each in the position which divides the surrounding wall of the tube 10 into three equally in radial direction, you may provide it in the position which is not divided into three. In the above description, an example in which the slit 11 is provided in order to form the belt 12 in the tube 10 has been shown. This slit forms a narrow gap in the tube 10, but may be provided with a slit instead of such a slit.

ここで、留置補助具60の別の構成例について説明する。
図12は、留置補助具60の別の構成例を示す概略断面図である。図13は、留置補助具60の更に別の構成例を示す概略図である。図14は、留置補助具60の更に別の構成例を示す概略図である。図15は、留置補助具60の更に別の構成例を示す概略断面図である。図16は、留置補助具60の更に別の構成例を示す概略断面図である。なお、図13(a)が留置補助具60の概略断面図を、図13(b)がチューブ10の先端部10Aの構成例を示す概略図を、それぞれ示している。また、図14(a)が留置補助具60の概略断面図を、図14(b)がチューブ10の先端部10Aの構成例を示す概略図を、図14(c)が留置補助具60の平面図を、それぞれ示している。
Here, another configuration example of the indwelling auxiliary tool 60 will be described.
FIG. 12 is a schematic sectional view showing another configuration example of the indwelling auxiliary tool 60. FIG. 13 is a schematic view showing still another configuration example of the indwelling auxiliary tool 60. FIG. 14 is a schematic view showing still another configuration example of the indwelling auxiliary tool 60. FIG. 15 is a schematic cross-sectional view showing still another configuration example of the indwelling auxiliary tool 60. FIG. 16 is a schematic cross-sectional view showing still another configuration example of the indwelling auxiliary tool 60. 13A shows a schematic cross-sectional view of the indwelling auxiliary tool 60, and FIG. 13B shows a schematic view showing a configuration example of the distal end portion 10A of the tube 10. 14A is a schematic cross-sectional view of the indwelling auxiliary tool 60, FIG. 14B is a schematic diagram illustrating a configuration example of the distal end portion 10A of the tube 10, and FIG. Each plan view is shown.

留置補助具60は、上述したように、チューブ10の翼部13の形状、つまり体内固定部Bの形状を維持するのに寄与する機能を有するものである。留置補助具60の一つの構成例について図1に基づいて説明したが、留置補助具60の構成をそれだけに限定するものではない。そこで、留置補助具60の別の構成例について説明する。図12〜図14では、留置補助具60の先端側保持部63の構成例を示している。図15及び図16では、留置補助具60の基端側保持部64の構成例を示している。   As described above, the indwelling auxiliary tool 60 has a function that contributes to maintaining the shape of the wing portion 13 of the tube 10, that is, the shape of the in-vivo fixing portion B. Although one configuration example of the indwelling auxiliary tool 60 has been described with reference to FIG. 1, the configuration of the indwelling auxiliary tool 60 is not limited thereto. Therefore, another configuration example of the indwelling auxiliary tool 60 will be described. 12-14, the structural example of the front end side holding | maintenance part 63 of the indwelling auxiliary tool 60 is shown. 15 and 16 show a configuration example of the proximal end side holding portion 64 of the indwelling auxiliary tool 60. FIG.

図12に示す留置補助具60は、図1で示した構成に加え、更に別部材の締結部61を備えている。この締結部61は、チューブ10の先端部10Aの保持をより強固にするために、先端側保持部63に対してチューブ10を外周側から締結するように設けられるようになっている。この締結部61は、たとえばO−リングなどで構成するとよい。   In addition to the structure shown in FIG. 1, the indwelling auxiliary tool 60 shown in FIG. The fastening portion 61 is provided so as to fasten the tube 10 from the outer peripheral side with respect to the distal end side holding portion 63 in order to more firmly hold the distal end portion 10A of the tube 10. The fastening portion 61 may be constituted by an O-ring, for example.

図13に示す留置補助具60は、図1で示した構成に加え、更に縮径部63bに形成された第1突起部63dを備えている。この第1突起部63dは、チューブ10の先端部10Aの少なくとも一部を引っかけることができるようにしたものである。第1突起部63dは、先端側保持部63の外壁、つまり縮径部63bの外壁の一部を径方向に突出させて形成するとよい。すなわち、第1突起部63dは、図17に示す突出部63fと同様の機能を有している。ただし、第1突起部63dを突出部63fと併用してもよい。このような第1突起部63dを形成する場合、チューブ10の先端部10Aにスリット11とは別の穴部(図13(b)に示す穴部10B)を形成し、穴部10Bに第1突起部63dを引っかけるようにするとよい。なお、スリット11を第1突起部63dに引っかけるようにしてもよい。   In addition to the configuration shown in FIG. 1, the indwelling auxiliary tool 60 shown in FIG. 13 further includes a first protrusion 63d formed on the reduced diameter portion 63b. The first protrusion 63d is configured to be able to hook at least a part of the distal end portion 10A of the tube 10. The first protrusion 63d may be formed by projecting a part of the outer wall of the distal end holding part 63, that is, the outer wall of the reduced diameter part 63b in the radial direction. That is, the first protrusion 63d has the same function as the protrusion 63f shown in FIG. However, the first protrusion 63d may be used in combination with the protrusion 63f. When such a first protrusion 63d is formed, a hole (a hole 10B shown in FIG. 13B) different from the slit 11 is formed in the distal end 10A of the tube 10, and the first in the hole 10B. The protrusion 63d may be hooked. The slit 11 may be hooked on the first protrusion 63d.

図14に示す留置補助具60は、図1で示した構成に加え、更に第2拡径部63cに形成された第2突起部63eを備えている。この第2突起部63eは、チューブ10の先端部10Aの少なくとも一部を引っかけることができるようにしたものである。第2突起部63eは、第2拡径部63cの外周の少なくとも一部をチューブ10の先端方向に立設させて形成されている。このような第2突起部63eを形成する場合、チューブ10に形成されているスリット11を第2突起部63eに引っかけるようにするとよい(図14(c)参照)。なお、図13(b)に示したような穴部10Bに第2突起部63eを引っかけるようにしてもよい。   In addition to the structure shown in FIG. 1, the indwelling auxiliary tool 60 shown in FIG. 14 further includes a second protrusion 63e formed on the second enlarged diameter portion 63c. The second protrusion 63e is configured to be able to hook at least a part of the distal end portion 10A of the tube 10. The second protrusion 63e is formed by standing at least a part of the outer periphery of the second enlarged diameter portion 63c in the distal direction of the tube 10. When forming such a 2nd projection part 63e, it is good to make the slit 11 currently formed in the tube 10 hook on the 2nd projection part 63e (refer FIG.14 (c)). Note that the second protrusion 63e may be hooked in the hole 10B as shown in FIG.

なお、第1突起部63d、第2突起部63eの形成個数を特に限定するものではなく、チューブ10に形成されているスリット11や穴部10Bの形成個数に対応させた個数で形成するとよい。また、第1突起部63dを第2突起部63eのような形状にしたり、第2突起部63eを第1突起部63dのような形状にしたりしてもよい。   Note that the numbers of the first protrusions 63d and the second protrusions 63e are not particularly limited, and the first protrusions 63d and the second protrusions 63e may be formed in numbers corresponding to the numbers of slits 11 and holes 10B formed in the tube 10. Alternatively, the first protrusion 63d may be shaped like the second protrusion 63e, or the second protrusion 63e may be shaped like the first protrusion 63d.

図15に示す留置補助具60は、図1で示した構成に加え、更に基端側保持部64が先端側から基端側に向けて徐々に縮径させたテーパー形状に形成されている。基端側保持部64をテーパー形状にすることで、チューブ10への挿入性を向上できるとともに、チューブ10の内周面を嵌め込み摩擦で保持できることになる。   In addition to the configuration shown in FIG. 1, the indwelling auxiliary tool 60 shown in FIG. 15 is further formed in a tapered shape in which the proximal end side holding portion 64 is gradually reduced in diameter from the distal end side toward the proximal end side. By making the proximal end holding portion 64 tapered, it is possible to improve the insertability into the tube 10 and to hold the inner peripheral surface of the tube 10 by friction by fitting.

図16に示す留置補助具60は、図1で示した構成に加え、更に基端側保持部64の外周面の少なくとも一部に拡径部64aを設け、その拡径部64aから基端側に向けて徐々に縮径させたテーパー形状を備えている。このようにすることで、図15に示した基端側保持部64のテーパー形状のテーパー角度よりも大きなテーパー角度を有するテーパー形状を形成することができ、チューブ10の内周面を嵌め込み摩擦で更に強固に保持できることになる。拡径部64aの径を特に限定するものではないが、たとえば先端側保持部63の第1拡径部63aと同程度にするとよい。   In addition to the configuration shown in FIG. 1, the indwelling auxiliary tool 60 shown in FIG. 16 is further provided with an enlarged diameter portion 64 a on at least a part of the outer peripheral surface of the proximal end side holding portion 64, and the proximal end side from the enlarged diameter portion 64 a. It has a tapered shape that is gradually reduced in diameter. By doing so, it is possible to form a taper shape having a taper angle larger than the taper angle of the taper shape of the proximal end side holding portion 64 shown in FIG. 15, and fitting the inner peripheral surface of the tube 10 with friction. It can be held more firmly. Although the diameter of the enlarged diameter part 64a is not specifically limited, For example, it is good to make it the same grade as the 1st enlarged diameter part 63a of the front end side holding part 63.

以上のように、留置補助具60の先端側保持部63がチューブ10の先端部10Aを保持し、基端側保持部64の外周面が翼部13の開始端Pよりも基端側の内周面と当接し、保持する。これにより、先端側保持部63と基端側保持部64とが、チューブ10の近位端(先端側)と遠位端(基端側)とが近づくことにより形成される翼部13の状態を維持させるようになっている。   As described above, the distal end side holding portion 63 of the indwelling auxiliary tool 60 holds the distal end portion 10 </ b> A of the tube 10, and the outer peripheral surface of the proximal end side holding portion 64 is on the inner side closer to the proximal end than the start end P of the wing portion 13. Abuts and holds the peripheral surface. Thereby, the state of the wing | blade part 13 formed by the front end side holding | maintenance part 63 and the base end side holding | maintenance part 64 approaching the proximal end (front end side) and distal end (base end side) of the tube 10 approaches. Is supposed to be maintained.

よって、図1、図12〜図16に示したような構成の留置補助具60を用いれば、たとえばチューブ10は、先端部10Aが先端側保持部63で、体内固定部Bの形成位置よりも基端側が基端側保持部64で、それぞれ保持されることになる。したがって、留置補助具60は、動きが激しく、内容物や体液に晒される消化管壁72内においても、形成された体内固定部の軸方向の他端側を基端側保持部64で保持した状態において先端側保持部63及び基端側保持部64の外周面が内容物や体液に晒されることがない。そのため、体内固定部Bの形状がより保たれやすくなり、瘻孔カテーテル1の留置状態を良好に保つことができ、自己抜去等の意図しない抜去を抑制することができる。   Therefore, if the indwelling auxiliary tool 60 having the configuration shown in FIGS. 1 and 12 to 16 is used, the tube 10 has, for example, the distal end portion 10A at the distal end side holding portion 63 and the position where the in-vivo fixing portion B is formed. The proximal end side is respectively held by the proximal end side holding portion 64. Therefore, the indwelling auxiliary tool 60 holds the other end side in the axial direction of the formed in-vivo fixed part by the proximal end holding part 64 even in the digestive tract wall 72 exposed to the contents and body fluids, which is intensely moved. In this state, the outer peripheral surfaces of the distal end side holding portion 63 and the proximal end side holding portion 64 are not exposed to the contents or body fluid. Therefore, the shape of the in-vivo fixing part B can be more easily maintained, the indwelling state of the fistula catheter 1 can be maintained well, and unintentional extraction such as self-extraction can be suppressed.

また、留置補助具60がチューブ10に挿入されると、留置補助具60の外周面がチューブ10の内腔に密着することになる。このため、留置補助具60とチューブ10との間に胃液や栄養液が入りにくくなり、留置補助具60とチューブ10との接触面の劣化を抑制することができる。また、留置補助具60が栄養剤等によって滑って外れてしまう等のトラブルが起きにくくなる。その結果、留置補助具60とチューブ10との密着状態が安定的に保たれ、体内固定部Bの形状が維持されることになる。   Further, when the indwelling auxiliary tool 60 is inserted into the tube 10, the outer peripheral surface of the indwelling auxiliary tool 60 comes into close contact with the lumen of the tube 10. For this reason, it becomes difficult for gastric juice and nutrient solution to enter between the indwelling aid 60 and the tube 10, and deterioration of the contact surface between the indwelling aid 60 and the tube 10 can be suppressed. In addition, troubles such as the indwelling aid 60 slipping off due to a nutrient or the like are less likely to occur. As a result, the close contact state between the indwelling auxiliary tool 60 and the tube 10 is stably maintained, and the shape of the in-vivo fixing part B is maintained.

1 瘻孔カテーテル、10 チューブ、10A 先端部、10B 穴部、10a 先端面、10b 先端部内周面、11 スリット、12 ベルト、13 翼部、14 近位端、15 遠位端、16 屈曲部、50 伸展具、51 係合部、52 操作部、53 軸部、60 留置補助具、60A 筒状本体部、61 締結部、63 先端側保持部、63a 第1拡径部、63b 縮径部、63c 第2拡径部、63d 第1突起部、63e 第2突起部、63f 突出部、64 基端側保持部、64a 拡径部、65 内部突起、66 中間部、67 貫通穴、71 腹壁、72 消化管壁、73 瘻孔、A カテーテル部、B 体内固定部。   DESCRIPTION OF SYMBOLS 1 1 fistula catheter, 10 tube, 10A tip part, 10B hole part, 10a tip surface, 10b tip part inner peripheral surface, 11 slit, 12 belt, 13 wing | blade part, 14 proximal end, 15 distal end, 16 bending part, 50 Extender, 51 engaging part, 52 operation part, 53 shaft part, 60 indwelling auxiliary tool, 60A cylindrical main body part, 61 fastening part, 63 distal end side holding part, 63a first enlarged diameter part, 63b reduced diameter part, 63c 2nd enlarged diameter part, 63d 1st projection part, 63e 2nd projection part, 63f protrusion part, 64 proximal end holding part, 64a enlarged diameter part, 65 internal projection, 66 middle part, 67 through hole, 71 abdominal wall, 72 Gastrointestinal wall, 73 fistula, A catheter part, B internal fixation part.

Claims (12)

瘻孔カテーテルに形成される体内固定部の留置補助具であって、
前記体内固定部に少なくとも一部が挿入される筒状本体部を有し、
前記筒状本体部は、
先端側に形成され、前記筒状本体部が挿入された前記体内固定部の軸方向の一端側を保持する先端側保持部と、
前記先端側保持部よりも基端側に形成され、前記筒状本体部が挿入された前記体内固定部の軸方向の他端側を外周面で軸方向に移動可能に保持する基端側保持部と、を備えた
ことを特徴とする留置補助具。
An indwelling aid for an internal fixation part formed on a fistula catheter,
It has a cylindrical main body part into which at least a part is inserted into the body fixing part,
The cylindrical main body is
A tip-side holding portion that is formed on the tip side and holds one end side in the axial direction of the in-vivo fixing portion into which the cylindrical main body portion is inserted;
Proximal-side holding that is formed on the proximal side of the distal-side holding portion and holds the other end side in the axial direction of the in-vivo fixing portion into which the cylindrical main body portion is inserted so as to be movable in the axial direction on the outer peripheral surface. And a detention aid.
前記先端側保持部は、
径方向外側に向かって突出させた部分を少なくとも一つ備えている
ことを特徴とする請求項1に記載の留置補助具。
The tip side holding part is
The indwelling auxiliary tool according to claim 1, comprising at least one portion projecting radially outward.
前記先端側保持部は、
径方向外側に向かって拡径したつば状の第1拡径部と、
前記第1拡径部の基端側に形成され、径方向内側に向かって前記第1拡径部よりも縮径した縮径部と、
前記縮径部の基端側に形成され、径方向外側に向かって拡径した第2拡径部と、を有している
ことを特徴とする請求項1又は2に記載の留置補助具。
The tip side holding part is
A collar-shaped first diameter-expanded portion that is expanded toward the outside in the radial direction;
A diameter-reduced portion formed on the proximal end side of the first diameter-expanded portion and having a diameter smaller than the first diameter-expanded portion toward the radially inner side;
The indwelling assisting tool according to claim 1, further comprising a second diameter-expanding portion that is formed on a proximal end side of the diameter-decreasing portion and has a diameter that increases toward the radially outer side.
前記縮径部は、
前記先端側保持部の外壁の少なくとも一部を径方向に突出させて形成した突起部を備えている
ことを特徴とする請求項3に記載の留置補助具。
The reduced diameter portion is
The indwelling auxiliary tool according to claim 3, further comprising a protrusion formed by projecting at least a part of the outer wall of the tip side holding portion in the radial direction.
前記第2拡径部は、
前記第2拡径部の外周の少なくとも一部を先端方向に立設させて形成した突起部を備えている
ことを特徴とする請求項3に記載の留置補助具。
The second enlarged diameter portion is
The indwelling auxiliary tool according to claim 3, further comprising a protrusion formed by standing at least a part of the outer periphery of the second enlarged diameter portion in the distal direction.
前記先端側保持部に対して、前記体内固定部の軸方向の一端側を外周側から締結する締結部を設けた
ことを特徴とする請求項1〜5のいずれか一項に記載の留置補助具。
The indwelling assistance according to any one of claims 1 to 5, wherein a fastening portion for fastening one end side in the axial direction of the in-vivo fixing portion from the outer peripheral side is provided for the distal end side holding portion. Ingredients.
前記基端側保持部の外周面の少なくとも一部を、先端側から基端側に向けてテーパー形状にしている
ことを特徴とする請求項1〜6のいずれか一項に記載の留置補助具。
The indwelling auxiliary tool according to any one of claims 1 to 6, wherein at least a part of the outer peripheral surface of the proximal end side holding portion is tapered from the distal end side toward the proximal end side. .
前記基端側保持部の外周面の少なくとも一部に径方向外側に向かって拡径した拡径部を設け、
その拡径部から基端側に向けてテーパー形状にしている
ことを特徴とする請求項1〜6のいずれか一項に記載の留置補助具。
A diameter-enlarged portion that is enlarged toward the radially outer side is provided on at least a part of the outer peripheral surface of the base-end holding portion,
The indwelling auxiliary tool according to any one of claims 1 to 6, wherein a tapered shape is formed from the enlarged diameter portion toward the base end side.
前記先端側保持部と前記基端側保持部との間における流体が流通可能な貫通穴を壁面の少なくとも一部に形成した
ことを特徴とする請求項1〜8のいずれか一項に記載の留置補助具。
The through-hole through which the fluid between the said front end side holding | maintenance part and the said base end side holding | maintenance part can distribute | circulate was formed in at least one part of the wall surface. Detention aid.
前記筒状本体部は、
その内周面が前記筒状本体部の内腔に挿入される伸展具の係合部の外面と密着するように内腔の径が決定されている
ことを特徴とする請求項1〜9のいずれか一項に記載の留置補助具。
The cylindrical main body is
The diameter of the lumen is determined so that the inner peripheral surface thereof is in close contact with the outer surface of the engaging portion of the extender inserted into the lumen of the cylindrical main body. The indwelling assistance tool as described in any one.
前記筒状本体部の内腔に内部突起を形成し、
この内部突起によって、前記筒状本体部の内腔に挿入される伸展具の係合部が係止される
ことを特徴とする請求項1〜9のいずれか一項に記載の留置補助具。
Forming an internal projection in the lumen of the cylindrical body,
The indwelling auxiliary tool according to any one of claims 1 to 9, wherein the engaging portion of the extender inserted into the lumen of the cylindrical main body portion is locked by the internal protrusion.
請求項1〜11のいずれか一項に記載の留置補助具と、
チューブを備えたカテーテル部と、
前記カテーテル部の遠位端側に形成され、消化管壁内に留置される体内固定部と、を有する瘻孔カテーテルにおいて、
前記体内固定部は、
前記チューブの先端部が前記留置補助具の先端側保持部に固定された状態で、
前記チューブの先端側と基端側とを近づけることにより、前記チューブの一部が径方向外側に向かって延び、さらにこれと反対側に屈曲して径方向内側に向かって延びる形状に変形させ、
前記チューブの変形位置から基端側で前記チューブを前記基端側保持部で保持することで形成している
ことを特徴とする瘻孔カテーテル。
The indwelling auxiliary tool according to any one of claims 1 to 11,
A catheter section with a tube;
A fistula catheter formed on the distal end side of the catheter part and having a body fixing part to be placed in the digestive tract wall;
The body fixing part is
With the tip of the tube fixed to the tip side holding part of the indwelling auxiliary tool,
By bringing the distal end side and the proximal end side of the tube close to each other, a part of the tube extends radially outward, further bent to the opposite side and deformed into a shape extending radially inward,
The fistula catheter is formed by holding the tube by the proximal-side holding portion on the proximal side from the deformed position of the tube.
JP2011028483A 2011-02-14 2011-02-14 Indwelling aid for fistula catheter and fistula catheter Active JP5769438B2 (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012176118A (en) * 2011-02-25 2012-09-13 Nihon Covidien Kk Fistula catheter

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