JP2014121451A - Gastric fistula catheter - Google Patents
Gastric fistula catheter Download PDFInfo
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- JP2014121451A JP2014121451A JP2012279461A JP2012279461A JP2014121451A JP 2014121451 A JP2014121451 A JP 2014121451A JP 2012279461 A JP2012279461 A JP 2012279461A JP 2012279461 A JP2012279461 A JP 2012279461A JP 2014121451 A JP2014121451 A JP 2014121451A
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- 206010065713 Gastric Fistula Diseases 0.000 title abstract description 6
- 238000004804 winding Methods 0.000 claims description 26
- 239000000725 suspension Substances 0.000 claims description 17
- 238000003780 insertion Methods 0.000 abstract description 34
- 230000037431 insertion Effects 0.000 abstract description 34
- 238000000605 extraction Methods 0.000 abstract description 6
- 238000004891 communication Methods 0.000 abstract description 3
- 206010016717 Fistula Diseases 0.000 description 22
- 230000003890 fistula Effects 0.000 description 22
- 238000000034 method Methods 0.000 description 16
- 210000002784 stomach Anatomy 0.000 description 12
- 239000000463 material Substances 0.000 description 6
- 239000007788 liquid Substances 0.000 description 4
- 235000015097 nutrients Nutrition 0.000 description 4
- 210000003815 abdominal wall Anatomy 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 235000016709 nutrition Nutrition 0.000 description 3
- 230000035764 nutrition Effects 0.000 description 3
- 229920003225 polyurethane elastomer Polymers 0.000 description 3
- 229920005989 resin Polymers 0.000 description 3
- 239000011347 resin Substances 0.000 description 3
- 229920002379 silicone rubber Polymers 0.000 description 3
- 239000004677 Nylon Substances 0.000 description 2
- 229920000122 acrylonitrile butadiene styrene Polymers 0.000 description 2
- 229920001778 nylon Polymers 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 241000272525 Anas platyrhynchos Species 0.000 description 1
- 239000004606 Fillers/Extenders Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 230000000994 depressogenic effect Effects 0.000 description 1
- 238000005553 drilling Methods 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 229910001000 nickel titanium Inorganic materials 0.000 description 1
- 229920005594 polymer fiber Polymers 0.000 description 1
- 229920005749 polyurethane resin Polymers 0.000 description 1
- 229920000915 polyvinyl chloride Polymers 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 229920002803 thermoplastic polyurethane Polymers 0.000 description 1
- WFKWXMTUELFFGS-UHFFFAOYSA-N tungsten Chemical compound [W] WFKWXMTUELFFGS-UHFFFAOYSA-N 0.000 description 1
- 229910052721 tungsten Inorganic materials 0.000 description 1
- 239000010937 tungsten Substances 0.000 description 1
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- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
Description
本発明は、胃瘻用カテーテルに関する。 The present invention relates to a gastrostomy catheter.
経口的に栄養を摂取できない患者に対する栄養の投与方法として、経皮内視鏡的胃瘻造設術（以下、「ＰＥＧ」と略す。）による経腸栄養管理が頻繁に行われるようになっている。このＰＥＧを実施するために胃瘻用カテーテルが使用される。 Enteral nutrition management by percutaneous endoscopic gastrostomy (hereinafter abbreviated as “PEG”) is frequently performed as a method for administering nutrition to patients who cannot take nutrition orally. A gastrostomy catheter is used to perform this PEG.
胃瘻用カテーテルはその留置手技、患者の容態、使用期間、介護者の操作性などから様々な種類が存在するが、一般に、栄養剤または薬液等の液状物質を体外から胃内へ導入する内腔を有し瘻孔の壁面に沿って伸びる可撓性チューブと、この可撓性チューブの先端部に付設され、可撓性チューブの径方向外側に拡径された張り出し状の体内留置部（バルーン等）から構成されている。 There are various types of catheters for gastrostomy, depending on the indwelling technique, patient condition, period of use, operability of caregivers, etc., but in general, liquid substances such as nutrients or chemicals are introduced into the stomach from outside the body. A flexible tube extending along the wall of the fistula, and a protruding indwelling portion (balloon) attached to the distal end of the flexible tube and expanded radially outward of the flexible tube Etc.).
この胃瘻用カテーテルは患者の腹壁から胃壁へと貫通する瘻孔に挿入されて留置される。胃瘻用カテーテルの瘻孔への挿入又は瘻孔からの抜去に際しては、瘻孔に体内留置部を通過させるために、体内留置部を伸長させる等によりできるだけ可撓性チューブと同程度まで外径を小さくして挿入抵抗及び抜去抵抗を低減することが望ましい。 This gastrostomy catheter is inserted and placed in a fistula that penetrates from the abdominal wall of the patient to the stomach wall. When inserting or removing the gastrostomy catheter from the fistula, in order to pass the indwelling part through the fistula, the outer diameter is reduced to the same extent as that of the flexible tube by extending the indwelling part. It is desirable to reduce insertion resistance and removal resistance.
このため胃瘻用カテーテルの瘻孔への挿入又は瘻孔からの抜去の際に体内留置部を可能な限り細径とできるよう伸展具を用いた手法（特許文献１）や体内留置部の形状の工夫（特許文献２）などが開示されている。 For this reason, when inserting or removing the gastrostomy catheter from the fistula, a technique using an extender (Patent Document 1) or a device for the shape of the indwelling part so that the indwelling part can be made as small as possible. (Patent Document 2) and the like are disclosed.
しかしながら、これらの方法によっても体内留置部を可撓性チューブと同等の外形まで細径化することは難しい。このため胃瘻用カテーテルの瘻孔への挿入又は瘻孔からの抜去の際に体内留置部は可撓性チューブから幾分張り出した形状となり、挿入抵抗や抜去抵抗が依然として存在する。 However, it is difficult to reduce the diameter of the indwelling portion to the same outer shape as the flexible tube by these methods. For this reason, when the gastrostomy catheter is inserted into the fistula or removed from the fistula, the indwelling portion has a shape protruding somewhat from the flexible tube, and insertion resistance and extraction resistance still exist.
本発明は上記の課題に鑑みてなされたものであり、胃瘻用カテーテルの瘻孔への挿入又は瘻孔からの抜去の際に体内留置部を可撓性チューブと同等程度の外径とすることにより挿入抵抗や抜去抵抗を低減し、患者への苦痛を軽減させることができる胃瘻用カテーテルを提供するものである。 The present invention has been made in view of the above problems, and by setting the indwelling portion to an outer diameter equivalent to that of a flexible tube when the gastrostomy catheter is inserted into or removed from the fistula. It is an object of the present invention to provide a gastrostomy catheter that can reduce insertion resistance and withdrawal resistance and reduce pain to a patient.
このような目的は、下記（１）〜（４）に記載の本発明により達成される。
（１）内腔を有する可撓性チューブ本体と、
第１の孔を有し、前記第１の孔と前記内腔とが連通するように前記可撓性チューブ本体の先端部に着脱自在に設けられた体内留置部と、
第２の孔を有し、前記第２の孔と前記内腔とが連通するように前記可撓性チューブ本体の基端部に着脱自在に設けられた体表固定部と、
一端が前記体内留置部に固定され、他端が前記体表固定部に着脱自在に連結された少なくとも１つの吊り具と、を備えることを特徴とする胃瘻用カテーテル。
（２）前記可撓性チューブ本体は、前記吊り具を摺動自在に保持するガイド溝を長手方向に有する（１）に記載の胃瘻用カテーテル。
（３）一端が前記体内留置部に固定され、他端が前記可撓性チューブ本体に着脱自在に連結された牽引具を更に有する（１）又は（２）に記載の胃瘻用カテーテル。
（４）前記吊り具の前記他端が固定された巻取り部材を更に備え、前記巻取り部材は前記吊り具を巻取り可能であり、かつ、前記体表固定部に着脱自在に連結されるよう構成されている（１）乃至（３）のいずれか一項に記載の胃瘻用カテーテル。
Such an object is achieved by the present invention described in the following (1) to (4).
(1) a flexible tube body having a lumen;
An indwelling portion having a first hole and detachably provided at a distal end portion of the flexible tube main body so that the first hole and the lumen communicate with each other;
A body surface fixing portion having a second hole and detachably provided at a base end portion of the flexible tube main body so that the second hole and the lumen communicate with each other;
A gastrostomy catheter comprising: one end fixed to the indwelling part, and the other end detachably connected to the body surface fixing part.
(2) The gastrostomy catheter according to (1), wherein the flexible tube body has a guide groove in a longitudinal direction for slidably holding the suspension.
(3) The gastrostomy catheter according to (1) or (2), further including a traction tool having one end fixed to the indwelling portion and the other end detachably connected to the flexible tube body.
(4) The winding device further includes a winding member to which the other end of the lifting tool is fixed. The winding member can wind the lifting device and is detachably connected to the body surface fixing portion. The gastrostomy catheter according to any one of (1) to (3), configured as described above.
本発明によれば、胃瘻用カテーテルの瘻孔への挿入又は瘻孔からの抜去の際に体内留置部を可撓性チューブと同等程度の外径とすることにより挿入抵抗や抜去抵抗を低減し、患者への苦痛を軽減させることができる。 According to the present invention, when the gastrostomy catheter is inserted into the fistula or removed from the fistula, the indwelling portion has an outer diameter comparable to that of the flexible tube, thereby reducing insertion resistance and removal resistance. Pain for the patient can be reduced.
以下、本発明の胃瘻用カテーテル１の実施形態について、図面を参照しつつ詳細に説明する。
図１は、本発明の実施形態に係る胃瘻用カテーテル１を表した側面図である。図２は、本実施形態に係る可撓性チューブ本体２を表した（ａ）上面図、（ｂ）側面図である。図３は、本実施形態に係る胃瘻用カテーテル１を表した上面図である。
Hereinafter, embodiments of the gastrostomy catheter 1 of the present invention will be described in detail with reference to the drawings.
FIG. 1 is a side view showing a gastrostomy catheter 1 according to an embodiment of the present invention. FIG. 2A is a top view and FIG. 2B is a side view showing the flexible tube main body 2 according to this embodiment. FIG. 3 is a top view showing the gastrostomy catheter 1 according to the present embodiment.
本実施形態の胃瘻用カテーテル１は、胃瘻へ留置され、体外から胃内への栄養剤や薬剤等の投与に用いられる。 The gastrostomy catheter 1 of this embodiment is placed in the gastrostoma and used for administration of nutrients, drugs, etc. from outside the body to the stomach.
図１に示すように、本実施形態の胃瘻用カテーテル１は、可撓性チューブ本体２と体内留置部３と体表固定部４とを備える組立体である。体内留置部３は可撓性チューブ本体２の先端部に着脱自在に設けられている。また、体表固定部４は可撓性チューブ本体２の基端部に着脱自在に設けられている。さらに、一端が体内留置部に固定され、他端が体表固定部に着脱自在に連結された少なくとも１つの吊り具５を有する。 As shown in FIG. 1, the gastrostomy catheter 1 of this embodiment is an assembly including a flexible tube body 2, an indwelling part 3, and a body surface fixing part 4. The indwelling portion 3 is detachably provided at the distal end portion of the flexible tube main body 2. The body surface fixing portion 4 is detachably provided at the proximal end portion of the flexible tube main body 2. Furthermore, it has at least one hanging tool 5 having one end fixed to the indwelling portion and the other end detachably connected to the body surface fixing portion.
可撓性チューブ本体２は胃瘻用カテーテル１の本体部分であり、瘻孔に留置され体外と胃内とを連通させる。図２に示すように、可撓性チューブ本体２は内腔２１を有し、この内腔２１を通して栄養剤や薬剤等が胃内へと投与される。 The flexible tube main body 2 is a main body portion of the gastrostomy catheter 1 and is placed in the fistula to allow communication between the outside of the body and the stomach. As shown in FIG. 2, the flexible tube body 2 has a lumen 21 through which nutrients, drugs, and the like are administered into the stomach.
内腔２１は上述のように栄養剤や薬剤等を胃内へと投与するのに用いられる。内腔２１は可撓性チューブ本体２の全長にわたって設けられており、基端側開口２２及び先端側開口２３で外部と連通している。 The lumen 21 is used to administer nutrients, drugs, etc. into the stomach as described above. The lumen 21 is provided over the entire length of the flexible tube main body 2 and communicates with the outside through the proximal end side opening 22 and the distal end side opening 23.
可撓性チューブ本体２には長手方向に沿ってガイド溝２４が設けられている。ガイド溝２４は後に説明するように可撓性チューブ本体２を瘻孔に挿入する際に吊り具５を保持する。本実施形態ではガイド溝２４は可撓性チューブ本体２の基端から先端まで連続する溝である。また、本実施形態ではガイド溝２４は可撓性チューブ本体２の外周に対向して一対形成されている。なお、ガイド溝２４の数は一対に限られず吊り具５の数に応じて適宜設定することができる。 The flexible tube main body 2 is provided with a guide groove 24 along the longitudinal direction. The guide groove 24 holds the hanger 5 when the flexible tube body 2 is inserted into the fistula as will be described later. In the present embodiment, the guide groove 24 is a groove that continues from the proximal end to the distal end of the flexible tube body 2. In the present embodiment, a pair of guide grooves 24 are formed to face the outer periphery of the flexible tube body 2. In addition, the number of the guide grooves 24 is not limited to a pair, and can be appropriately set according to the number of the hanging tools 5.
内腔２１の先端側開口２３近傍には、ダックビル弁２５が設けられている。ダックビル弁２５は、可撓性チューブ本体２の基端側から先端側への液体等の流入は許容するが、先端側から基端側への液体等の流出は阻止するように形成されている。このため、胃瘻用カテーテル１を介しての胃内容物の体外への漏出が良好に防止される。 A duck bill valve 25 is provided in the vicinity of the distal end side opening 23 of the lumen 21. The duckbill valve 25 is formed so as to allow inflow of liquid or the like from the proximal end side to the distal end side of the flexible tube body 2 but prevent outflow of liquid or the like from the distal end side to the proximal end side. . For this reason, the leakage of the gastric contents to the outside of the body through the gastrostomy catheter 1 is satisfactorily prevented.
なお、本実施形態ではダックビル弁２５を内腔２１の先端側開口２３から突出するように設けたが、設置位置はこれに限られず、基端側開口２２の近傍や内腔２１の中央部等どこに設けてもよい。また、弁の形状もダックビル弁に限られず、一方向への液体流入のみを許容する機能を有するものであればいかなる形態のものを使用してもよい。 In this embodiment, the duckbill valve 25 is provided so as to protrude from the distal end side opening 23 of the lumen 21, but the installation position is not limited to this, and the vicinity of the proximal end opening 22, the central portion of the lumen 21, etc. It can be installed anywhere. Further, the shape of the valve is not limited to the duckbill valve, and any shape may be used as long as it has a function of allowing only liquid inflow in one direction.
可撓性チューブ本体２としては、可撓性を有する材料であればいかなる材料を用いることもできる。特に可撓性チューブ本体２として生体適合性の高いシリコーンやポリウレタンエラストマーを用いることにより、胃瘻用カテーテル１を安全に長期間留置することができるため好ましい。 As the flexible tube body 2, any material can be used as long as it is flexible. Particularly, it is preferable to use a highly biocompatible silicone or polyurethane elastomer as the flexible tube body 2 because the gastrostomy catheter 1 can be safely placed for a long period of time.
ここで、可撓性チューブ本体２の代表的な寸法例について説明する。まず、本実施形態の可撓性チューブ本体２は、全長１５〜６０ｍｍ程度、外径４〜１０ｍｍ程度、内径２〜８ｍｍ程度である。また、ガイド溝２４は、幅０．３〜１．５ｍｍ程度、深さ０．３〜１．５ｍｍ程度である。 Here, typical dimensions of the flexible tube body 2 will be described. First, the flexible tube main body 2 of the present embodiment has a total length of about 15 to 60 mm, an outer diameter of about 4 to 10 mm, and an inner diameter of about 2 to 8 mm. The guide groove 24 has a width of about 0.3 to 1.5 mm and a depth of about 0.3 to 1.5 mm.
体内留置部３は胃壁の内側に係止して胃瘻用カテーテル１が体外へと抜け落ちるのを防止する。図１に示すように、本実施形態の体内留置部３は略円筒状をなしている。体内留置部３の長手方向の中央部近傍には第１の孔３１が形成されている。胃瘻用カテーテル１では、第１の孔３１には可撓性チューブ本体２の弁２５が挿入される。したがって、第１の孔３１と内腔２１とは連通するように組み合わされる。 The indwelling part 3 is locked inside the stomach wall to prevent the gastrostomy catheter 1 from falling out of the body. As shown in FIG. 1, the indwelling part 3 of the present embodiment has a substantially cylindrical shape. A first hole 31 is formed in the vicinity of the central portion in the longitudinal direction of the indwelling portion 3. In the gastrostomy catheter 1, the valve 25 of the flexible tube body 2 is inserted into the first hole 31. Therefore, the first hole 31 and the lumen 21 are combined so as to communicate with each other.
体内留置部３の一端には挿入補助具係合部３４が設けられている。挿入補助具係合部３４は胃瘻用カテーテル１の瘻孔への挿入の際に、後に説明する挿入補助具８の体内留置部固定部８２と係合する部分である。本実施形態では挿入補助具係合部３４は体内留置部３の一端に設けられた穴である。具体的には挿入補助具係合部３４は、体内留置部３の一端から長手方向に陥没して形成されている。穴の深さは第１の孔３１と連通しなければいかなる深さとしてもよいが、体内留置部３の強度の観点から体内留置部３の全長の４分の１程度であることが好ましい。 An insertion aid engaging portion 34 is provided at one end of the indwelling portion 3. The insertion assisting tool engaging portion 34 is a portion that engages with an indwelling portion fixing portion 82 of the insertion assisting device 8 described later when the gastrostomy catheter 1 is inserted into the fistula. In the present embodiment, the insertion assisting tool engaging portion 34 is a hole provided at one end of the indwelling portion 3. Specifically, the insertion assisting tool engaging portion 34 is formed to be depressed in the longitudinal direction from one end of the indwelling portion 3. The depth of the hole may be any depth as long as it does not communicate with the first hole 31, but is preferably about a quarter of the total length of the indwelling portion 3 from the viewpoint of the strength of the indwelling portion 3.
また、第１の孔３１の基端側開口３２の近傍には後に説明する吊り具５の一端が固定されている。本実施形態では吊り具５は２つであり、吊り具５は基端側開口３２近傍の対向する２箇所でそれぞれ固定される。吊り具５の固定はいかなる方法を用いてもよいが、本実施形態では体表固定部４に付設した吊り具連結部４４に係止し、固定カバー７で覆うことにより固定されている。 In addition, one end of a hanger 5 described later is fixed in the vicinity of the proximal end side opening 32 of the first hole 31. In the present embodiment, there are two suspension tools 5, and the suspension tools 5 are respectively fixed at two opposing positions in the vicinity of the proximal end side opening 32. Any method may be used to fix the hanger 5, but in this embodiment, the hanger 5 is fixed by being locked to a hanger connecting portion 44 attached to the body surface fixing portion 4 and covering with a fixing cover 7.
さらに体内留置部３の挿入補助具係合部３４を設けた端部と逆の端部（他端）には後に説明する牽引具６の一端が固定されている。固定部は体内留置部３の軸線上に設けると後に説明する体内留置部３の回収操作がスムーズになり好ましい。牽引具６の固定はいかなる方法を用いてもよいが、本実施形態では体内留置部３の他端にワイヤを結ぶことにより固定されている。 Furthermore, one end of the traction tool 6 to be described later is fixed to the end (other end) opposite to the end provided with the insertion assisting tool engaging portion 34 of the indwelling portion 3. It is preferable that the fixing portion is provided on the axis of the indwelling portion 3 because the recovery operation of the indwelling portion 3 described later becomes smooth. The traction tool 6 may be fixed by any method, but in the present embodiment, the traction tool 6 is fixed by connecting a wire to the other end of the indwelling portion 3.
体内留置部３としては、可撓性を有する材料であればいかなる材料を用いることもできる。特に体内留置部３として生体適合性の高いシリコーンやポリウレタンエラストマーを用いることにより、胃瘻用カテーテル１を安全に長期間留置することができるため好ましい。 As the indwelling part 3, any material can be used as long as it is flexible. In particular, it is preferable to use silicone or polyurethane elastomer having high biocompatibility as the indwelling portion 3 because the gastrostomy catheter 1 can be safely placed for a long period of time.
ここで、体内留置部３の代表的な寸法例について説明する。まず、本実施形態の体内留置部３は、全長１０〜４０ｍｍ程度、外径５〜１０ｍｍ程度である。また、第１の孔３１の径は２〜８ｍｍ程度である。挿入補助具係合部３４は、径が３〜８ｍｍ程度、深さが３〜１０ｍｍ程度である。 Here, the typical example of a dimension of the indwelling part 3 is demonstrated. First, the indwelling part 3 of the present embodiment has a total length of about 10 to 40 mm and an outer diameter of about 5 to 10 mm. The diameter of the first hole 31 is about 2 to 8 mm. The insertion assisting tool engaging portion 34 has a diameter of about 3 to 8 mm and a depth of about 3 to 10 mm.
体表固定部４は体表面に係止して胃瘻用カテーテル１が体内へと脱落するのを防止する。図１に示すように、本実施形態の体表固定部４は略平板状をなしている。体表固定部４の長手方向の中央部近傍には第２の孔４１が形成されている。胃瘻用カテーテル１では、第２の孔４１には可撓性チューブ本体２の基端部が挿入される。したがって、第２の孔４１と内腔２１とは連通するように組み合わされる。 The body surface fixing part 4 is locked to the body surface to prevent the gastrostomy catheter 1 from falling into the body. As shown in FIG. 1, the body surface fixing part 4 of the present embodiment has a substantially flat plate shape. A second hole 41 is formed near the center of the body surface fixing portion 4 in the longitudinal direction. In the gastrostomy catheter 1, the proximal end portion of the flexible tube body 2 is inserted into the second hole 41. Therefore, the second hole 41 and the lumen 21 are combined so as to communicate with each other.
図３に示すように、体表固定部４の上面には吊り具連結部４４が設けられている。吊り具連結部４４は後に説明する吊り具５の基端部又は基端部に設けられた巻取り部材５２を着脱自在に連結する部分である。本実施形態では吊り具連結部４４は体表固定部４の上面に設けられた凹部である。具体的には吊り具連結部４４は、体表固定部４の第２の孔４１の基端側開口４２を挟んで一対形成されている。それぞれの吊り具連結部４４は巻取り部材５２を収容可能な大きさの凹部であり、巻取り部材５２を係止する凸部４５が内部に設けられている。 As shown in FIG. 3, a hanger connecting portion 44 is provided on the upper surface of the body surface fixing portion 4. The hanger connecting portion 44 is a portion that removably connects the winding member 52 provided at the base end portion or the base end portion of the hanger 5 described later. In the present embodiment, the hanging tool connecting portion 44 is a recess provided on the upper surface of the body surface fixing portion 4. Specifically, a pair of lifting tool connecting portions 44 are formed across the proximal end side opening 42 of the second hole 41 of the body surface fixing portion 4. Each of the hanger connecting portions 44 is a recess having a size that can accommodate the take-up member 52, and a protrusion 45 that locks the take-up member 52 is provided inside.
更に体表固定部４はキャップ部４６を有する。キャップ部４６は第２の孔４１及び内腔２１の基端側開口２２を封止する。図１に示すようにキャップ部４６は一端が体表固定部４６の一端に固定され、他端に突部が形成されている。この突部を第２の孔４１及び内腔２１の基端側開口２２に挿入して封止する。なお、本実施形態の胃瘻用カテーテル１では、使用時には固定カバー７により体表固定部４の上面を覆っている。 Furthermore, the body surface fixing part 4 has a cap part 46. The cap part 46 seals the second hole 41 and the proximal end side opening 22 of the lumen 21. As shown in FIG. 1, one end of the cap portion 46 is fixed to one end of the body surface fixing portion 46, and a protrusion is formed at the other end. This protrusion is inserted into the second hole 41 and the proximal opening 22 of the lumen 21 and sealed. In the gastrostomy catheter 1 of the present embodiment, the upper surface of the body surface fixing portion 4 is covered with the fixing cover 7 during use.
体表固定部４としては、可撓性を有する材料であればいかなる材料を用いることもできる。特に体表固定部４として生体適合性の高いシリコーンやポリウレタンエラストマーを用いることにより、胃瘻用カテーテル１を安全に長期間留置することができるため好ましい。 Any material can be used as the body surface fixing portion 4 as long as it is a flexible material. In particular, it is preferable to use a highly biocompatible silicone or polyurethane elastomer as the body surface fixing portion 4 because the gastrostomy catheter 1 can be safely placed for a long period of time.
ここで、体表固定部４の代表的な寸法例について説明する。まず、本実施形態の体表固定部４は、縦１０〜４０ｍｍ程度、横４〜１０ｍｍ程度、厚さ１〜１０ｍｍ程度である。また、第２の孔４１の径は２〜８ｍｍ程度である。 Here, a typical dimension example of the body surface fixing part 4 will be described. First, the body surface fixing | fixed part 4 of this embodiment is about 10-40 mm in length, about 4-10 mm in width, and about 1-10 mm in thickness. The diameter of the second hole 41 is about 2 to 8 mm.
吊り具５は体内留置部３に固定され、体内留置部３を胃壁の内側に接触した状態で保持する。図１に示すように、本実施形態の吊り具５はワイヤからなる吊り具本体５１と吊り具本体５１の基端に設けられた巻取り部材５２とを備える。吊り具本体５１の先端は前述のように体内留置部３の第１の孔３１の基端側開口３２近傍に固定されている。本実施形態の胃瘻用カテーテル１は吊り具５を一対有している。 The hanger 5 is fixed to the indwelling part 3 and holds the indwelling part 3 in contact with the inside of the stomach wall. As shown in FIG. 1, the hanger 5 of the present embodiment includes a hanger body 51 made of a wire and a winding member 52 provided at the proximal end of the hanger body 51. The distal end of the lifting device main body 51 is fixed in the vicinity of the proximal end side opening 32 of the first hole 31 of the indwelling portion 3 as described above. The gastrostomy catheter 1 of the present embodiment has a pair of suspension tools 5.
巻取り部材５２は吊り具本体５１の基端に固定される。巻取り部材５２により吊り具本体５１を巻き取ることで吊り具５の長さを調節することができる。本実施形態では巻取り部材５２は孔５３を有する略円筒状をなしている。さらに、巻取り部材５２は厚さ方向の中央部に周回する溝が形成されている。吊り具本体５１はこの溝に沿って巻き取られる。 The winding member 52 is fixed to the base end of the hanger body 51. The length of the hanger 5 can be adjusted by winding the hanger body 51 with the winding member 52. In the present embodiment, the winding member 52 has a substantially cylindrical shape having a hole 53. Further, the winding member 52 is formed with a groove that circulates in the central portion in the thickness direction. The hanger body 51 is wound along this groove.
吊り具本体５１としては、適度な引張り強度を有するものであればいかなる材料を用いることもできる。このような材料として、例えば、ステンレス鋼やタングステン、ニッケル−チタン合金などの金属、ナイロン樹脂、ＡＢＳ樹脂、ウレタン樹脂、ＰＶＣ樹脂などの高分子ファイバーを用いることができる。また、巻取り部材５２としては例えば、ナイロン樹脂、ＡＢＳ樹脂、ポリウレタン樹脂などを用いることができる。 Any material can be used as the hanger body 51 as long as it has an appropriate tensile strength. As such a material, for example, a metal such as stainless steel, tungsten, or a nickel-titanium alloy, or a polymer fiber such as nylon resin, ABS resin, urethane resin, or PVC resin can be used. Further, as the winding member 52, for example, nylon resin, ABS resin, polyurethane resin, or the like can be used.
ここで、吊り具５の代表的な寸法例について説明する。まず、本実施形態の吊り具本体５１は、全長１５〜８０ｍｍ程度、外径４〜１０ｍｍ程度である。また、巻取り部材５２の径は２〜８ｍｍ程度、厚さは１〜５ｍｍ程度である。 Here, the typical dimension example of the hanger 5 is demonstrated. First, the hanger body 51 of the present embodiment has a total length of about 15 to 80 mm and an outer diameter of about 4 to 10 mm. Moreover, the diameter of the winding member 52 is about 2-8 mm, and thickness is about 1-5 mm.
図１に示すように、本実施形態の胃瘻用カテーテル１は更に牽引具６を備える。牽引具６は胃瘻用カテーテル１を抜去する際に体内留置部３を体内から取り除くのに用いられる。牽引具６はワイヤ状をなしており、一端が体内留置部３に固定されている。また、牽引具６の他端はリング状の把持部６１となっている。 As shown in FIG. 1, the gastrostomy catheter 1 of this embodiment further includes a traction tool 6. The traction tool 6 is used to remove the indwelling portion 3 from the body when the gastrostomy catheter 1 is removed. The traction tool 6 has a wire shape, and one end is fixed to the indwelling portion 3. Further, the other end of the traction tool 6 is a ring-shaped gripping portion 61.
次に、胃瘻用カテーテル１の使用方法について説明する。図５から図９は本発明の実施形態に係る胃瘻用カテーテル１の使用方法を説明した図である。 Next, a method for using the gastrostomy catheter 1 will be described. FIG. 5 to FIG. 9 are views for explaining how to use the gastrostomy catheter 1 according to the embodiment of the present invention.
初めに胃瘻用カテーテル１の挿入に使用する挿入補助具８について図４を用いて説明する。挿入補助具８は本体部８１と、本体部８１の先端部に設けられた体内留置部固定部８２と、本体部８１の基端部に設けられた把持部８３とを備える。挿入補助具８は瘻孔に体内留置部３及び吊り具５を挿入するのを補助する。 First, an insertion assisting tool 8 used for inserting the gastrostomy catheter 1 will be described with reference to FIG. The insertion assisting tool 8 includes a main body portion 81, an in-vivo indwelling portion fixing portion 82 provided at the distal end portion of the main body portion 81, and a gripping portion 83 provided at the proximal end portion of the main body portion 81. The insertion assisting tool 8 assists the insertion of the indwelling part 3 and the lifting tool 5 into the fistula.
本体部８１は瘻孔を通過して体内留置部３を胃内に導入する役割を果たす。本実施形態では本体部８１は断面円形の棒状をなしている。なお、断面の形状は円形に限られず多角形状や楕円状等でも板状でもよい。本体部８１の外径は瘻孔を通過できる大きさであれば特に限定されないが、瘻孔の拡張に用いたダイレータと同じ程度の外径であると過剰な瘻孔の拡張を抑止できるため好ましい。 The main body part 81 plays a role of introducing the indwelling part 3 into the stomach through the fistula. In the present embodiment, the main body 81 has a rod shape with a circular cross section. The shape of the cross section is not limited to a circle, and may be a polygonal shape, an elliptical shape, or a plate shape. The outer diameter of the main body 81 is not particularly limited as long as it is large enough to pass through the fistula, but it is preferable that the outer diameter is the same as that of the dilator used for fistula expansion because excessive expansion of the fistula can be suppressed.
体内留置部固定部８２は後に説明する吊り具固定部８４とともに体内留置部３を挿入補助具８に固定する役割を担う。本実施形態では体内留置部固定部８２は本体部８１の先端に設けられた棒状の部材である。体内留置部固定部８２は体内留置部３の挿入補助具係合部３４に挿入される。 The indwelling part fixing part 82 plays a role of fixing the indwelling part 3 to the insertion assisting tool 8 together with a suspension fixing part 84 described later. In this embodiment, the indwelling portion fixing portion 82 is a rod-like member provided at the tip of the main body portion 81. The indwelling part fixing part 82 is inserted into the insertion assisting tool engaging part 34 of the indwelling part 3.
把持部８３は挿入補助具８を用いた体内留置部３の挿入時に把持される部分である。本実施形態では把持部８３は本体部８１の基端に設けられた棒状体である。 The grip portion 83 is a portion that is gripped when the indwelling portion 3 is inserted using the insertion assisting tool 8. In the present embodiment, the grip portion 83 is a rod-like body provided at the base end of the main body portion 81.
吊り具固定部８４は体内留置部固定部８２とともに体内留置部３を挿入補助具８に固定する。本実施形態では吊り具固定部８４は本体部８１の基端側にこれと直交して一対設けられている。そして、２つの巻取り部材５２の孔５３がそれぞれ吊り具固定部８４に挿入されることにより、体内留置部３は挿入補助具８に３点固定される。 The suspension fixture fixing portion 84 fixes the indwelling portion 3 together with the indwelling portion fixing portion 82 to the insertion assisting tool 8. In the present embodiment, a pair of suspension fixture fixing portions 84 is provided on the base end side of the main body portion 81 so as to be orthogonal thereto. Then, the indwelling portion 3 is fixed to the insertion assisting tool 8 at three points by inserting the holes 53 of the two winding members 52 into the suspension fixing portions 84 respectively.
次に胃瘻用カテーテル１の挿入手順について説明する。本実施形態の胃瘻用カテーテル１は既に形成された瘻孔に挿入される。すなわち、造設時においては公知の方法で形成された瘻孔に挿入され、交換時には既存の瘻孔に挿入される。瘻孔の形成については胃壁及び腹壁を固定した後にダイレータにより穿孔する方法が一般的である。 Next, a procedure for inserting the gastrostomy catheter 1 will be described. The gastrostomy catheter 1 of this embodiment is inserted into a previously formed fistula. That is, it is inserted into a well formed by a known method at the time of construction, and is inserted into an existing well at the time of replacement. For the formation of a fistula, a method of drilling with a dilator after fixing the stomach wall and abdominal wall is common.
図５に示すように、本実施形態の胃瘻用カテーテル１の挿入にはまず、挿入補助具８に体内留置部３、吊り具５及び牽引具６の組立体を固定する。すなわち、前述のように体内留置部３の挿入補助具係合部３４に体内留置部固定部８２を挿入する。さらに２つの巻取り部材５２を吊り具固定部８４に係合させる。そして巻取り部材５２により吊り具本体５１を巻き取り、吊り具本体５１を弛みのない状態とする。また、把持部６１に体内留置部３及び本体部８１を通して牽引具６を本体部８１の基端側に固定する。これにより体内留置部３は軸方向が本体部８１の軸と一致するようにして挿入補助具８に固定される。この状態で図５に示すように体内留置部３を瘻孔に挿入する。 As shown in FIG. 5, to insert the gastrostomy catheter 1 of the present embodiment, first, an assembly of the indwelling portion 3, the suspension device 5, and the traction device 6 is fixed to the insertion assisting device 8. That is, as described above, the indwelling portion fixing portion 82 is inserted into the insertion assisting tool engaging portion 34 of the indwelling portion 3. Further, the two winding members 52 are engaged with the suspension fixture fixing portion 84. Then, the hoisting body 51 is wound up by the winding member 52 so that the hoisting body 51 is not slackened. Further, the traction tool 6 is fixed to the proximal end side of the main body part 81 through the indwelling part 3 and the main body part 81 in the grasping part 61. Accordingly, the indwelling portion 3 is fixed to the insertion assisting tool 8 so that the axial direction thereof coincides with the axis of the main body portion 81. In this state, the indwelling part 3 is inserted into the fistula as shown in FIG.
次いで巻取り部材５２を吊り具固定部８４から取り外す。そして挿入補助具８を瘻孔から抜去する。この状態で吊り具本体５１の巻き取り量を調整し、図６に示すように体内留置部３が胃壁の内面に接するようにする。 Next, the winding member 52 is removed from the suspension fixture fixing portion 84. Then, the insertion aid 8 is removed from the fistula. In this state, the winding amount of the hanger body 51 is adjusted so that the indwelling portion 3 comes into contact with the inner surface of the stomach wall as shown in FIG.
次いで図７に示すように体表固定部４を前記の組立体に固定する。具体的には、体表固定部４の第２の孔４１の先端側開口４３から基端側開口４２の方へと巻取り部材５２及び吊り具本体５１を通す。そして巻取り部材５２を吊り具連結部４４に装着する。吊り具連結部４４は内部に凸部４５が形成されており、これと巻取り部材５２の孔５３を係合させる。係合させた状態で巻取り部材５２で吊り具本体５１を巻き取り、体内留置部３と体表固定部４とで腹壁及び胃壁を挟み込むように長さを調節する。 Next, as shown in FIG. 7, the body surface fixing portion 4 is fixed to the assembly. Specifically, the winding member 52 and the suspension main body 51 are passed from the distal end side opening 43 of the second hole 41 of the body surface fixing portion 4 toward the proximal end side opening 42. Then, the take-up member 52 is attached to the suspension connecting portion 44. The hanger connecting portion 44 has a convex portion 45 formed therein, and engages with the hole 53 of the winding member 52. The suspension body 51 is wound up by the winding member 52 in the engaged state, and the length is adjusted so that the abdominal wall and stomach wall are sandwiched between the indwelling portion 3 and the body surface fixing portion 4.
さらに図８に示すように組立体に可撓性チューブ本体２を装着する。具体的には、体表固定部４の第２の孔４１の基端側から可撓性チューブ２を挿入する。このとき一対のガイド溝２４のそれぞれに吊り具本体５１が収容されるようにして挿入することにより可撓性チューブ本体２は逸脱することなく真っ直ぐに挿入される。最終的に可撓性チューブ本体２の内腔２１が体内留置部３の第１の孔３１と連通するまで挿入すると図９に示す状態となる。 Further, the flexible tube main body 2 is attached to the assembly as shown in FIG. Specifically, the flexible tube 2 is inserted from the base end side of the second hole 41 of the body surface fixing portion 4. At this time, the flexible tube main body 2 is inserted straight without deviating by inserting the suspension tool main body 51 so as to be accommodated in each of the pair of guide grooves 24. When the lumen 21 of the flexible tube body 2 is finally inserted until it communicates with the first hole 31 of the indwelling portion 3, the state shown in FIG. 9 is obtained.
最後に体表固定部４に固定カバー７を装着して巻取り部材５２が体表固定部４から外れないように覆うことにより図１に示す胃瘻用カテーテル１の留置が完了する。 Finally, the fixing cover 7 is attached to the body surface fixing portion 4 to cover the winding member 52 so as not to be detached from the body surface fixing portion 4, thereby completing the indwelling of the gastrostomy catheter 1 shown in FIG.
胃瘻用カテーテル１の抜去は上述の挿入と逆の手順で行うことができる。ただし、図６に示す状態となったら吊り具本体５１を切断し巻取り部材５２を取り除く。そして牽引具６の把持具６１を把持して体内留置部３を吊り下げた状態で引き抜く。 The removal of the gastrostomy catheter 1 can be performed by a procedure reverse to the above-described insertion. However, when the state shown in FIG. 6 is reached, the hanger body 51 is cut and the winding member 52 is removed. Then, the grasping tool 61 of the traction tool 6 is grasped and pulled out in a state where the indwelling portion 3 is suspended.
以上のように本発明の胃瘻用カテーテル１を用いると、体内留置部３を可撓性チューブ本体２と同等程度の外径とすることにより、挿入抵抗や抜去抵抗を低減し、患者への苦痛を低減させることができる。 As described above, when the gastrostomy catheter 1 of the present invention is used, the indwelling portion 3 has an outer diameter comparable to that of the flexible tube body 2, thereby reducing insertion resistance and removal resistance, Pain can be reduced.
１ 胃瘻用カテーテル
２ 可撓性チューブ本体
２１ 内腔
２２ 基端側開口
２３ 先端側開口
２４ ガイド溝
２５ 弁
３ 体内留置部
３１ 第１の孔
３２ 基端側開口
３３ 先端側開口
３４ 挿入補助具係合部
４ 体表固定部
４１ 第２の孔
４２ 基端側開口
４３ 先端側開口
４４ 吊り具連結部
４５ 凸部
４６ キャップ部
５ 吊り具
５１ 吊り具本体
５２ 巻取り部材
５３ 孔
６ 牽引具
６１ 把持部
７ 固定カバー
８ 挿入補助具
８１ 本体部
８２ 体内留置部固定部
８３ 把持部
８４ 吊り具固定部
DESCRIPTION OF SYMBOLS 1 Gastric fistula catheter 2 Flexible tube main body 21 Lumen 22 Base end side opening 23 Front end side opening 24 Guide groove 25 Valve 3 Body indwelling part 31 1st hole 32 Base end side opening 33 Front end side opening 34 Insertion aid Engagement part 4 Body surface fixing part 41 Second hole 42 Base end side opening 43 Front end side opening 44 Lifting tool connecting part 45 Protruding part 46 Cap part 5 Lifting tool 51 Lifting tool body 52 Winding member 53 Hole 6 Traction tool 61 Grip part 7 Fixed cover 8 Insertion aid 81 Main body part 82 Indwelling part fixing part 83 Gripping part 84 Suspension tool fixing part
Claims (4)
第１の孔を有し、前記第１の孔と前記内腔とが連通するように前記可撓性チューブ本体の先端部に着脱自在に設けられた体内留置部と、
第２の孔を有し、前記第２の孔と前記内腔とが連通するように前記可撓性チューブ本体の基端部に着脱自在に設けられた体表固定部と、
一端が前記体内留置部に固定され、他端が前記体表固定部に着脱自在に連結された少なくとも１つの吊り具と、を備えることを特徴とする胃瘻用カテーテル。 A flexible tube body having a lumen;
An indwelling portion having a first hole and detachably provided at a distal end portion of the flexible tube main body so that the first hole and the lumen communicate with each other;
A body surface fixing portion having a second hole and detachably provided at a base end portion of the flexible tube main body so that the second hole and the lumen communicate with each other;
A gastrostomy catheter comprising: one end fixed to the indwelling part, and the other end detachably connected to the body surface fixing part.
Priority Applications (1)
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| JP2012279461A JP6094207B2 (en) | 2012-12-21 | 2012-12-21 | Gastrostomy catheter |
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| JP2012279461A JP6094207B2 (en) | 2012-12-21 | 2012-12-21 | Gastrostomy catheter |
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| JP2014121451A true JP2014121451A (en) | 2014-07-03 |
| JP6094207B2 JP6094207B2 (en) | 2017-03-15 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2018161286A (en) * | 2017-03-27 | 2018-10-18 | テルモ株式会社 | Gastric fistula tube device |
| WO2019111847A1 (en) * | 2017-12-04 | 2019-06-13 | 住友ベークライト株式会社 | Gastrostomy catheter, insertion jig set, insertion jig, and gastrostomy catheter set |
| JP2019098146A (en) * | 2017-12-04 | 2019-06-24 | 住友ベークライト株式会社 | Gastric fistula catheter |
| JP2020018680A (en) * | 2018-08-02 | 2020-02-06 | 住友ベークライト株式会社 | Insertion jig set, insertion jig and gastrostoma catheter set |
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| US6315789B1 (en) * | 1999-02-08 | 2001-11-13 | Andrew H. Cragg | Medical device anchoring system and method |
| US6402722B1 (en) * | 1997-10-01 | 2002-06-11 | Scimed Life Systems, Inc. | Apparatus and method for percutaneously placing gastrostomy tubes |
| JP2003290321A (en) * | 2002-04-01 | 2003-10-14 | Top:Kk | Gastro-tube |
| JP2005511206A (en) * | 2001-12-10 | 2005-04-28 | アプライド メデイカル リサーチ | Gastrostomy instrument package and assembly method |
| JP2005168979A (en) * | 2003-12-15 | 2005-06-30 | Olympus Corp | Gastric fistula catheter |
| JP2006296794A (en) * | 2005-04-21 | 2006-11-02 | Nippon Sherwood Medical Industries Ltd | Indwelling device |
| US20090259189A1 (en) * | 2006-08-03 | 2009-10-15 | Delegge Rebecca | Catheter assembly including foldable internal bolster |
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| US6402722B1 (en) * | 1997-10-01 | 2002-06-11 | Scimed Life Systems, Inc. | Apparatus and method for percutaneously placing gastrostomy tubes |
| US6315789B1 (en) * | 1999-02-08 | 2001-11-13 | Andrew H. Cragg | Medical device anchoring system and method |
| JP2005511206A (en) * | 2001-12-10 | 2005-04-28 | アプライド メデイカル リサーチ | Gastrostomy instrument package and assembly method |
| JP2003290321A (en) * | 2002-04-01 | 2003-10-14 | Top:Kk | Gastro-tube |
| JP2005168979A (en) * | 2003-12-15 | 2005-06-30 | Olympus Corp | Gastric fistula catheter |
| JP2006296794A (en) * | 2005-04-21 | 2006-11-02 | Nippon Sherwood Medical Industries Ltd | Indwelling device |
| US20090259189A1 (en) * | 2006-08-03 | 2009-10-15 | Delegge Rebecca | Catheter assembly including foldable internal bolster |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2018161286A (en) * | 2017-03-27 | 2018-10-18 | テルモ株式会社 | Gastric fistula tube device |
| WO2019111847A1 (en) * | 2017-12-04 | 2019-06-13 | 住友ベークライト株式会社 | Gastrostomy catheter, insertion jig set, insertion jig, and gastrostomy catheter set |
| JP2019098146A (en) * | 2017-12-04 | 2019-06-24 | 住友ベークライト株式会社 | Gastric fistula catheter |
| JP7114402B2 (en) | 2017-12-04 | 2022-08-08 | 住友ベークライト株式会社 | gastrostomy catheter |
| JP2020018680A (en) * | 2018-08-02 | 2020-02-06 | 住友ベークライト株式会社 | Insertion jig set, insertion jig and gastrostoma catheter set |
| JP7316029B2 (en) | 2018-08-02 | 2023-07-27 | 住友ベークライト株式会社 | Insertion jig set, insertion jig and gastrostomy catheter set |
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|---|---|
| JP6094207B2 (en) | 2017-03-15 |
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