JP2011045738A - Dilator for fistulization - Google Patents

Dilator for fistulization Download PDF

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JP2011045738A
JP2011045738A JP2010239398A JP2010239398A JP2011045738A JP 2011045738 A JP2011045738 A JP 2011045738A JP 2010239398 A JP2010239398 A JP 2010239398A JP 2010239398 A JP2010239398 A JP 2010239398A JP 2011045738 A JP2011045738 A JP 2011045738A
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diameter member
fistula
diameter
small
dilator
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JP5036858B2 (en
JP2011045738A5 (en
Inventor
Yutaka Suzuki
裕 鈴木
Hideaki Matsunami
秀明 松波
Yukihiko Sakaguchi
幸彦 坂口
Yasumasa Koshiro
康雅 小城
Zenetsu Suzuki
善悦 鈴木
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Sumitomo Bakelite Co Ltd
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Sumitomo Bakelite Co Ltd
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Abstract

<P>PROBLEM TO BE SOLVED: To provide an instrument for measuring length of a fistula which can shorten an operation time and reduce the number of parts for a treatment tool. <P>SOLUTION: The dilator for fistulization has a scale mark on its body part. The scale mark is printed by a laser marker. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

本発明は、胃瘻の造設術に用いられる瘻孔造設術用拡張器に関する。   The present invention relates to a dilator for fistula construction used for gastrostomy construction.

近年、栄養又は薬液等を経口的に摂取できない患者に対して、患者の腹部に経皮的内視鏡下胃瘻造設術(Percutaneous Endoscopic Gastrost
omy、以下、PEGと略す。)により胃瘻を造設し、該胃瘻から栄養又は薬液等を投与
する経腸栄養管理が頻繁に行われるようになってきた。
In recent years, percutaneous endoscopic gastrostomy in the patient's abdomen for patients who cannot take nutrients or chemicals orally.
omy, hereinafter abbreviated as PEG. ), And enteral nutrition management has been frequently performed in which a gastrostomy is constructed and nutrition or a chemical solution is administered from the gastrostomy.

該PEGは、腹壁及び胃壁に瘻孔を開け、該瘻孔に、体内留置部材、チューブ部材及び体外留置部材からなるカテーテルを挿入し、該カテーテルを腹部に留置することにより、胃瘻を造設する手術方法であり、胃内に内視鏡を挿入しながら、(1)腹壁と胃壁とを固定する工程、(2)腹壁及び胃壁に穿刺針を刺し、貫通孔を形成する工程、(3)貫通孔にガイドワイヤを挿入する工程、(4)ガイドワイヤに沿って、瘻孔造設術用拡張器を貫通孔に挿入し、貫通孔の径を拡張して瘻孔を形成する工程、(5)瘻孔長を測定する工程、(6)ガイドワイヤに沿って、カテーテルを瘻孔に挿入する工程、(7)ガイドワイヤを抜去する工程からなる。なお、本発明において、貫通孔とは、瘻孔造設術用拡張器で、拡張される前又は拡張中の孔を指し、一方、瘻孔とは、瘻孔造設術用拡張器で拡張された後の孔を指す。   The PEG is an operation for creating a gastrostoma by opening a fistula in the abdominal wall and stomach wall, inserting a catheter comprising an indwelling member, a tube member and an extracorporeal indwelling member into the fistula, and placing the catheter in the abdomen. (1) fixing the abdominal wall and stomach wall while inserting an endoscope into the stomach, (2) piercing the abdominal wall and stomach wall with a puncture needle to form a through hole, and (3) penetration A step of inserting a guide wire into the hole; (4) a step of inserting a fistula construction dilator along the guide wire into the through hole to expand the diameter of the through hole to form a fistula; and (5) a fistula length. (6) a step of inserting a catheter into the fistula along the guide wire, and (7) a step of removing the guide wire. In the present invention, the through-hole refers to a hole before or during expansion with a fistula construction dilator, while the fistula refers to a hole after being expanded with a fistula dilator. Point to.

該(5)瘻孔長を測定する工程は、造設された瘻孔の長さに合ったカテーテルを選択するために、瘻孔長、すなわち、腹壁及び胃壁の厚みの合計を測定する工程である。該PEGにおいて、胃壁と腹壁とが密着するような適切な長さのチューブ部材を有するカテーテルを選択する必要がある。チューブ部材の長さが、胃壁および腹壁の厚さよりも短いカテーテルを装着した場合、カテーテルに付属された栄養剤通路が胃内へ挿通されていないため、その後に実施される栄養剤、薬剤が胃内へ正確に注入されず、腹膜炎を引き起こす場合がある。一方、チューブ部材の長さが、胃壁および腹壁の厚さよりも長いカテーテルを装着した場合、体外に出ているチューブ部材に、割りガーゼ等を挟み込んで、カテーテルを固定することができるが、極めて長いカテーテルを装着してしまった場合には、体外に突出する部分が多くなり、患者の生活に支障を与えてしまう場合がある。従って、瘻孔長を予め測定し、チューブ部材の長さが適切なカテーテルを選択する必要がある。   The step (5) of measuring the fistula length is a step of measuring the fistula length, that is, the total thickness of the abdominal wall and stomach wall, in order to select a catheter that matches the length of the fistula constructed. In the PEG, it is necessary to select a catheter having a tube member having an appropriate length so that the stomach wall and the abdominal wall are in close contact with each other. When a catheter with a tube member whose length is shorter than the thickness of the stomach wall and abdominal wall is attached, the nutrient channel attached to the catheter is not inserted into the stomach. It may not be accurately injected into the body and may cause peritonitis. On the other hand, when a catheter whose length is longer than the thickness of the stomach wall and abdominal wall is attached, the catheter can be fixed by sandwiching a split gauze or the like in the tube member that is outside the body, but it is extremely long When a catheter is attached, there are many portions that protrude outside the body, which may hinder the patient's life. Therefore, it is necessary to measure the fistula length in advance and select a catheter having an appropriate tube member length.

従来より用いられていた瘻孔長測定器を、図4及び図5を用いて示す。図4は、自由状態の従来の瘻孔長測定器を示し、図5は、瘻孔長の測定時の従来の瘻孔長測定器を示す。図4中、瘻孔長測定器30は、目盛31が印字されているアウターチューブ32、該アウターチューブ内を自由に摺動するインナーシャフト33、一端が該アウターチューブ32の体外側末端34と、他端が該インナーシャフト33の体外側末端35と接合しており、自由状態では屈曲した形状を有するアーム部材36、及び一端のみが該インナーシャフト33の体内側末端37と接合しており、自由状態では該インナーシャフト33に沿って閉じている突出部38からなる。   A conventionally used fistula length measuring instrument will be described with reference to FIGS. 4 and 5. FIG. FIG. 4 shows a conventional fistula length measuring instrument in a free state, and FIG. 5 shows a conventional fistula length measuring instrument when measuring the fistula length. In FIG. 4, the fistula length measuring device 30 includes an outer tube 32 on which a scale 31 is printed, an inner shaft 33 that freely slides in the outer tube, one end of the outer tube 32 outside the body 34, and the like. The end is joined to the body outer end 35 of the inner shaft 33, and the arm member 36 having a bent shape in the free state, and only one end is joined to the body inner end 37 of the inner shaft 33, the free state Then, it consists of a protruding portion 38 that is closed along the inner shaft 33.

従来、瘻孔長の測定は、以下のようにして行われていた。先ず、瘻孔造設術用拡張器で貫通孔を拡張して形成された瘻孔に、該瘻孔長測定器30を、該突出部38が閉じた状態で挿入する。次いで、図5に示すように、該アーム部材36に外力39を加えて、該アーム部材36を、略直線形状に変形させる。この時、該インナーシャフト33が、該アウターチューブ32内を体外側に向かって移動することにより、該突出部38が開く。次いで、該突出部38が開かれた状態で、該瘻孔長測定器30を体外側に引張り、該突出部38を胃壁の内側40に接触させ、該目盛31で、瘻孔長を測定する。つまり、従来の瘻孔長測定器30は、該突出部38を胃内壁に接触させることにより、目盛の基点(ゼロ点)を、胃壁の内側に合わせ、瘻孔長の測定を行う器具である。   Conventionally, the measurement of the fistula length has been performed as follows. First, the fistula length measuring device 30 is inserted into the fistula formed by expanding the through hole with the fistula construction dilator with the protruding portion 38 closed. Next, as shown in FIG. 5, an external force 39 is applied to the arm member 36 to deform the arm member 36 into a substantially linear shape. At this time, when the inner shaft 33 moves in the outer tube 32 toward the outside of the body, the protruding portion 38 opens. Next, with the protrusion 38 opened, the fistula length measuring device 30 is pulled outward, the protrusion 38 is brought into contact with the inner side 40 of the stomach wall, and the fistula length is measured with the scale 31. That is, the conventional fistula length measuring instrument 30 is a device that measures the fistula length by bringing the protruding portion 38 into contact with the stomach inner wall so that the base point (zero point) of the scale is aligned with the inside of the stomach wall.

例えば、特許文献1の米国特許第6,764,453号公報に開示されている瘻孔長測定器、及び特許文献2の米国5,356,382号公報に開示されている瘻孔長測定器のいずれも、上述したように、自由状態では閉じている突出部を、胃内に挿入後、胃内で開き、開いた突出部と胃壁の内側を接触させることにより、目盛の基点を胃壁の内側に合わせるものである。   For example, any of the fistula length measuring device disclosed in US Pat. No. 6,764,453 of Patent Document 1 and the fistula length measuring device disclosed in US Pat. No. 5,356,382 of Patent Document 2 However, as described above, the protrusion that is closed in the free state is inserted into the stomach and then opened in the stomach, and the open protrusion and the inside of the stomach wall are brought into contact with each other, so that the base point of the scale is placed inside the stomach wall. It is to match.

米国特許第6,764,453号公報US Pat. No. 6,764,453 米国特許第5,356,382号公報US Pat. No. 5,356,382

ところが、上記の瘻孔長測定器は、複数の部品で構成されるため、成形、組立の工程が煩雑であり、高価なものであった。そして、瘻孔造設術用拡張器で貫通孔を拡張して瘻孔を形成させた後、該瘻孔造設術用拡張器を引き抜き、別の器具である瘻孔長測定器を挿入して、該(5)瘻孔長を測定する工程を行う必要があるため、手術時間が長くなること及び処置具の部品点数が多くなるという問題があった。   However, since the above-mentioned hole length measuring device is composed of a plurality of parts, the molding and assembling steps are complicated and expensive. And after expanding a through-hole with a dilator for fistula construction and forming a fistula, this dilator for fistula construction is pulled out, and a fistula length measuring device which is another instrument is inserted, (5) Since it is necessary to perform the process of measuring the fistula length, there are problems that the operation time becomes long and the number of parts of the treatment tool increases.

従って、本発明の課題は、手術時間の短縮ができ且つ処理具の部品点数を削減できる瘻孔長測定器を提供することにある。   Therefore, the subject of this invention is providing the fistula length measuring device which can shorten the operation time and can reduce the number of parts of a processing tool.

本発明者らは、上記従来技術における課題を解決すべく、鋭意研究を重ねた結果、瘻孔造設術用拡張器の胴体部に目盛を付することにより、該瘻孔造設術用拡張器が、瘻孔長測定器を兼ねることができるので、手術時間の短縮及び処理具の部品点数の削減が可能となることを見出し、本発明を完成させるに至った。   As a result of intensive studies to solve the above-described problems in the prior art, the present inventors attach a scale to the trunk portion of the dilator for fistula construction so that the fistula dilator is a fistula. Since it can also serve as a length measuring device, it has been found that the operation time can be reduced and the number of parts of the processing tool can be reduced, and the present invention has been completed.

すなわち、本発明は、胴体部に目盛を有する瘻孔造設術用拡張器を提供するものである。   That is, this invention provides the dilator for fistula construction which has a scale in a trunk | drum.

本発明の瘻孔造設術用拡張器によれば、瘻孔造設術の手術時間の短縮且つ処理具の部品点数の削減が可能となる。   According to the expander for fistula construction of the present invention, it is possible to shorten the operation time of fistula construction and reduce the number of parts of the processing tool.

本発明の実施の形態例の瘻孔造設術用拡張器の模式図を示す。The schematic diagram of the dilator for fistula construction of the example of embodiment of this invention is shown. 大径部材先端部5の先端12(小径部材先端部9の先端16)の端面拡大図である。It is an end surface enlarged view of the front-end | tip 12 of the large diameter member front-end | tip part 5 (tip 16 of the small diameter member front-end | tip part 9). 瘻孔長測定工程を説明する模式図である。It is a schematic diagram explaining a fistula length measurement process. 自由状態の従来の瘻孔長測定器を示す。1 shows a conventional fistula length measuring instrument in a free state. 瘻孔長の測定時の従来の瘻孔長測定器を示す。The conventional fistula length measuring device at the time of fistula length measurement is shown.

本発明の実施の形態例の瘻孔造設術用拡張器を、図1を参照して説明する。図1は、本発明の実施の形態例の瘻孔造設術用拡張器の模式図を示し、図1中(I−1)は、挿通前の小径部材及び大径部材を示す模式図であり、図1中(I−2)は、大径部材に小径部材が挿通された状態の瘻孔造設術用拡張器を示す模式図であり、図1中(I−3)は、(I−2)の模式的な断面図である。図1中、瘻孔造設術用拡張器1は、大径部材3及び小径部材7から構成されている。図1中(I−1)に示すように、該大径部材3は、円筒形状の大径部材胴体部4、先端に向かって径が小さくなっている大径部材先端部5及び該大径部材胴体部4の末端に付設されている大径部材側コネクタ6からなり、該大径部材胴体部4には、目盛2が付されている。また、該小径部材7は、円筒形状の小径部材胴体部8、先端に向かって径が小さくなっている小径部材先端部9、及び該小径部材胴体部8の末端に付設されている小径部材側コネクタ10からなる。そして、図1中(I−2)に示すように、該大径部材3の内部に該小径部材7が挿通され、該大径部材側コネクタ6及び該小径部材側コネクタ10により、該大径部材3に該小径部材7が固定されて、該瘻孔造設術用拡張器1となる。   An expander for fistula construction according to an embodiment of the present invention will be described with reference to FIG. FIG. 1 shows a schematic diagram of a dilator for fistula construction according to an embodiment of the present invention, and (I-1) in FIG. 1 is a schematic diagram showing a small-diameter member and a large-diameter member before insertion, (I-2) in FIG. 1 is a schematic view showing a dilator for fistula construction in a state where a small-diameter member is inserted into a large-diameter member, and (I-3) in FIG. 1 is (I-2) FIG. In FIG. 1, the fistula construction dilator 1 is composed of a large-diameter member 3 and a small-diameter member 7. As shown in (I-1) in FIG. 1, the large-diameter member 3 includes a cylindrical large-diameter member body portion 4, a large-diameter member distal end portion 5 whose diameter decreases toward the distal end, and the large-diameter member. The large-diameter member-side connector 6 is provided at the end of the member body 4, and the scale 2 is attached to the large-diameter member body 4. The small-diameter member 7 includes a cylindrical small-diameter member body portion 8, a small-diameter member tip portion 9 whose diameter decreases toward the tip, and a small-diameter member side attached to the end of the small-diameter member body portion 8. It consists of a connector 10. Then, as shown in FIG. 1 (I-2), the small diameter member 7 is inserted into the large diameter member 3, and the large diameter member side connector 6 and the small diameter member side connector 10 cause the large diameter member The small-diameter member 7 is fixed to the member 3 to form the fistula dilator 1.

該大径部材3は、中空であり、内部に該小径部材7を挿通できる構造である。   The large diameter member 3 is hollow and has a structure in which the small diameter member 7 can be inserted.

該大径部材胴体部4の外径は、造設される瘻孔の内径と同じ大きさなので、留置するカテーテルのチューブ部材の外径により、適宜選択される。つまり、該大径部材胴体部4の外径は、該チューブ部材の外径と略同一か、又は該チューブ部材の外径より0.5〜3.0mm大きく、好ましくは1.0〜2.0mm大きい。そして、患者への負担を軽減するために、該大径部材胴体部4の外径は、カテーテルのチューブ部材の外径より若干大きいことが好ましく、該カテーテルのチューブ部材の外径は、通常、6〜12mm、好ましくは7〜9mmなので、該大径部材胴体部4の外径は、通常、7〜13mm、好ましくは8〜10mmである。   Since the outer diameter of the large-diameter member body 4 is the same as the inner diameter of the fistula to be constructed, it is appropriately selected depending on the outer diameter of the tube member of the catheter to be placed. That is, the outer diameter of the large-diameter member body 4 is substantially the same as the outer diameter of the tube member or 0.5 to 3.0 mm larger than the outer diameter of the tube member, preferably 1.0 to 2. 0 mm larger. And in order to reduce the burden on the patient, the outer diameter of the large-diameter member body 4 is preferably slightly larger than the outer diameter of the tube member of the catheter, and the outer diameter of the tube member of the catheter is usually Since it is 6-12 mm, preferably 7-9 mm, the outer diameter of the large-diameter member body 4 is usually 7-13 mm, preferably 8-10 mm.

該大径部材胴体部4の内径は、該小径部材7が挿通され得る大きさであれば、特に制限されないが、好ましくは4〜10mm、特に好ましくは5〜7mmである。   The inner diameter of the large-diameter member body portion 4 is not particularly limited as long as the small-diameter member 7 can be inserted, but is preferably 4 to 10 mm, particularly preferably 5 to 7 mm.

該大径部材先端部5は、先端に向かって外径が小さくなっている円錐形状である。該大径部材先端部5の先端の内径及び外径について、図2を参照して説明する。図2は、該大径部材先端部5の先端12の端面拡大図である。図2(II−1)中、該大径部材先端部5の先端12の内径13は、該小径部材胴体部8の外径と略同一であり、該小径部材胴体部8の大きさにより、適宜選択される。また、該大径部材先端部5の先端12の外径14は、該大径部材先端部5の先端12の内径13の値に近い程、該瘻孔造設術用拡張器で貫通孔を拡張させる際に、該先端12での抵抗が少なくなる点で好ましく、図2(II−2)に示すように、該大径部材先端部5の先端12の内径13と同じであることが最も好ましい。   The large-diameter member distal end portion 5 has a conical shape whose outer diameter decreases toward the distal end. The inner diameter and outer diameter of the distal end of the large-diameter member distal end portion 5 will be described with reference to FIG. FIG. 2 is an enlarged view of the end surface of the tip 12 of the large-diameter member tip 5. In FIG. 2 (II-1), the inner diameter 13 of the tip 12 of the large-diameter member tip 5 is substantially the same as the outer diameter of the small-diameter member body 8, and the size of the small-diameter member body 8 It is selected appropriately. Further, as the outer diameter 14 of the distal end 12 of the large diameter member distal end portion 5 is closer to the value of the inner diameter 13 of the distal end 12 of the large diameter member distal end portion 5, the through hole is expanded by the fistula construction dilator. At this time, it is preferable in that the resistance at the tip 12 is reduced, and most preferably the same as the inner diameter 13 of the tip 12 of the large-diameter member tip 5 as shown in FIG. 2 (II-2).

該大径部材3の全長15は、少なくとも、術者が手で握る部分、腹壁の厚み及び胃壁の厚みの合計の長さ以上の長さであり、好ましくは50〜300mm、特に好ましくは180〜230mmである。   The total length 15 of the large-diameter member 3 is at least the total length of the part grasped by the operator, the thickness of the abdominal wall and the thickness of the stomach wall, preferably 50 to 300 mm, particularly preferably 180 to 230 mm.

該目盛2は、該大径部材胴体部4に付されている。つまり、該目盛2の付される部分は、該大径部材3の該大径部材先端部5を除く部分である。該目盛2の基点11、すなわち、ゼロ点11は、該大径部材胴体部4の任意の位置であり、該目盛2は、該基点11から、該大径部材3の末端に向かって付されている。該目盛2としては、特に制限されないが、該基点11から末端に向かって一定の間隔で付される横棒及び数字であることが好ましい。該目盛2の目盛間隔は、特に制限されないが、5mm間隔であることが望ましく、また、特に強調したい箇所に数値が付されていることが望ましい。また、存在するカテーテルの長さに対応する位置にのみに目盛が付されていてもよい。該基点11は、瘻孔長の測定時に、胃内で、内視鏡により確認されなければならないので、内視鏡下で確認し易いこと、すなわち、目盛の基点を示す横棒が、他の横棒より太いか、又は0の数字が他の数字より大きいことが好ましい。また、該目盛2は、目盛が見易くなるように、該目盛2と該目盛2以外の大径部材3との区別が明確になるようなインクの色又は印字方法で印字された目盛であることが、好ましく、シリコーンインクで印字された目盛であることが、十分な剥離強度が得られ且つ該目盛2と該目盛2以外の大径部材3との区別が明確になる点で、特に好ましい。また、胃内に該瘻孔造設術用拡張器1が挿入された時に、該目盛2がどの方向に向いていても、内視鏡下で該基点11を確認し易いように、該基点11の横棒が、該大径部材胴体部4の全周に亘って付されていることが好ましい。該目盛2の範囲は、特に制限されないが、通常、瘻孔の長さが5〜50mmであるため、実用的には0〜100mmの範囲で目盛が付されていればよい。   The scale 2 is attached to the large-diameter member body 4. That is, the portion to which the scale 2 is attached is a portion excluding the large-diameter member tip 5 of the large-diameter member 3. The base point 11 of the scale 2, that is, the zero point 11 is an arbitrary position of the large-diameter member body portion 4, and the scale 2 is attached from the base point 11 toward the end of the large-diameter member 3. ing. The scale 2 is not particularly limited, but is preferably a horizontal bar and a number attached at regular intervals from the base point 11 toward the end. The scale interval of the scale 2 is not particularly limited, but is preferably 5 mm interval, and it is desirable that a numerical value is given to a portion to be particularly emphasized. Moreover, the scale may be attached | subjected only to the position corresponding to the length of the existing catheter. The base point 11 must be confirmed by an endoscope in the stomach at the time of measuring the fistula length, so that it is easy to confirm under the endoscope, that is, the horizontal bar indicating the base point of the scale is the other side. Preferably it is thicker than the bar or the number 0 is larger than the other numbers. The scale 2 is a scale printed with an ink color or a printing method so that the distinction between the scale 2 and the large-diameter member 3 other than the scale 2 is clear so that the scale is easy to see. However, the scale printed with silicone ink is particularly preferable because sufficient peel strength is obtained and the distinction between the scale 2 and the large-diameter member 3 other than the scale 2 becomes clear. In addition, when the fistula dilator 1 is inserted into the stomach, no matter which direction the scale 2 is oriented, the base point 11 can be easily confirmed under an endoscope. It is preferable that a horizontal bar is attached over the entire circumference of the large-diameter member body 4. The range of the scale 2 is not particularly limited. However, since the length of the fistula is usually 5 to 50 mm, the scale may be practically provided in the range of 0 to 100 mm.

該目盛2を該大径部材胴体部4に付す方法としては、特に制限されず、例えば、ホットスタンプ(熱転写)により印字する方法、シリコーンインクにより印字する方法、UV硬化型インクにより印字する方法、COレーザーマーカー、LDレーザーマーカー、YAGレーザーマーカー等のレーザーマーカーにより印字する方法等が挙げられるが、該大径部材胴体部4への印字が可能であれば、特に制限されない。これらのうち、シリコーンインクにより印字する方法が、インクの硬化時間が短いので、製造時間を短縮できる点、及び膜厚印刷が可能なので、他の印字方法に比べ、該目盛2が視覚的に見易く、該目盛2と該目盛2以外の大径部材3との区別が明確になる点で、好ましい。また、これらのうち、レーザーマーカーにより印字する方法が、短時間で印字でき且つインク等を必要としない点で好ましく、YAGレーザーマーカーにより印字する方法が、該目盛2が鮮明になる点で特に好ましい。また、UV硬化型インクにより印字する方法は、樹脂に印字する方法として一般的に広く用いられているため、既存の設備を使用でき、新たな設備投資が必要でないので、安価に印字ができる点で好ましい。また、フッ素樹脂は、自己潤滑性、耐化学薬品性、優れた機械特性を有しているので、該大径部材3の該大径部材胴体部4及び大径部材先端部5並びに該小径部材7の該小径部材胴体部8及び該小径部材先端部9の材質としては、該フッ素樹脂がしばしば使用される。しかし、該フッ素樹脂には、印字が困難な場合があり、その場合には、該フッ素樹脂に印字するための工夫が必要である。例えば、シリコーンインク又はUV硬化型インクにより印字をする場合、該大径部材胴体部4の材質が、該フッ素樹脂であると、インクがはじかれたり、あるいは、十分な剥離強度が得られないことがあるので、この場合は、予めプラズマ処理等の表面処理を行なえばよい。なお、該大径部材胴体部4の材質が、ポリビニリデンジフルオライド樹脂(PVDF樹脂)である場合は、表面処理等を予め施さなくても、UV硬化型インクによる印字が可能である。また、シリコーンインクにより印字する方法では、スクリーン印刷で印字することが、UV硬化型インクにより印字する方法では、回転印刷で印字することが、円形の部材に対して、一度の作業で全周に亘って印字が可能である点で好ましい。 The method for attaching the scale 2 to the large-diameter member body portion 4 is not particularly limited. For example, a method of printing by hot stamp (thermal transfer), a method of printing by silicone ink, a method of printing by UV curable ink, Examples of the method include printing with a laser marker such as a CO 2 laser marker, an LD laser marker, and a YAG laser marker. However, there is no particular limitation as long as printing on the large-diameter member body 4 is possible. Among these, the method of printing with silicone ink has a short ink curing time, and thus can reduce the manufacturing time, and the film thickness printing is possible. Therefore, the scale 2 is visually easy to see compared to other printing methods. The scale 2 and the large-diameter member 3 other than the scale 2 are preferable in that the distinction is clear. Of these, the method of printing with a laser marker is preferable in that printing can be performed in a short time and no ink is required, and the method of printing with a YAG laser marker is particularly preferable in that the scale 2 becomes clear. . Also, the method of printing with UV curable ink is generally widely used as a method of printing on resin, so existing equipment can be used and no new capital investment is required, so printing can be performed at low cost. Is preferable. Also, since the fluororesin has self-lubricating properties, chemical resistance, and excellent mechanical properties, the large-diameter member body 4 and the large-diameter member tip 5 of the large-diameter member 3 and the small-diameter member As the material of the small-diameter member body portion 8 and the small-diameter member front end portion 7, the fluororesin is often used. However, the fluororesin may be difficult to print, and in that case, a device for printing on the fluororesin is required. For example, when printing is performed with silicone ink or UV curable ink, if the material of the large-diameter member body 4 is the fluororesin, the ink may be repelled or sufficient peel strength may not be obtained. In this case, surface treatment such as plasma treatment may be performed in advance. If the material of the large-diameter member body 4 is polyvinylidene difluoride resin (PVDF resin), printing with UV curable ink is possible without performing surface treatment or the like in advance. In addition, in the method of printing with silicone ink, printing by screen printing is possible, and in the method of printing by UV curable ink, printing by rotary printing is performed on the entire circumference of a circular member in one operation. It is preferable in that printing can be performed over the entire area.

該小径部材7は、中空であり、内部にガイドワイヤを挿通することができる構造である。   The small diameter member 7 is hollow and has a structure in which a guide wire can be inserted.

該小径部材胴体部8の外径は、特に制限されないが、該小径部材7は、通常、1.0〜1.3mmの内径及び1.4〜1.7mmの外径を有する穿刺針を、腹壁及び胃壁に貫通させて形成させた貫通孔の拡張を、最初に行う部材なので、該穿刺針の外径に比べ大きくし過ぎることは、患者への負担が大きくなる。そのため、該小径部材胴体部8の外径は、好ましくは2〜8mm、特に好ましくは2.5〜4.5mmである。   Although the outer diameter of the small-diameter member body portion 8 is not particularly limited, the small-diameter member 7 is usually a puncture needle having an inner diameter of 1.0 to 1.3 mm and an outer diameter of 1.4 to 1.7 mm. Since the through-hole formed by penetrating the abdominal wall and stomach wall is the first member to be expanded, making it too large compared to the outer diameter of the puncture needle increases the burden on the patient. Therefore, the outer diameter of the small-diameter member body portion 8 is preferably 2 to 8 mm, particularly preferably 2.5 to 4.5 mm.

該小径部材胴体部8の内径は、該小径部材7の内部にガイドワイヤが挿通され得る大きさであれば、特に制限されないが、好ましくは1.3〜6mm、特に好ましくは1.4〜1.8mmである。   The inner diameter of the small-diameter member body 8 is not particularly limited as long as the guide wire can be inserted into the small-diameter member 7, but is preferably 1.3 to 6 mm, particularly preferably 1.4 to 1. .8 mm.

該小径部材先端部9は、先端に向かって外径が小さくなっている円錐形状である。該小径部材先端部9の先端16の内径17は、ガイドワイヤに沿って、該小径部材7(又は該瘻孔造設術用拡張器1)が摺動可能な大きさであれば、特に制限されず、ガイドワイヤの外径により、適宜選択される。そして、該小径部材先端部9の先端16とガイドワイヤとの間のクリアランス、すなわち、該先端16の外径17とガイドワイヤの外径の差は、0〜0.2mm、好ましくは0.02〜0.09mmである。通常、該ガイドワイヤとしては、外径が0.89mmの0.035”ガイドワイヤが用いられるため、該0.035”ガイドワイヤを用いる場合は、該小径部材先端部9の先端16の内径17は、好ましくは0.9〜1.1mm、特に好ましくは0.92〜0.98mmである。また、該小径部材先端部9の先端16の外径18は、該小径部材先端部9の先端16の内径17の値に近い程、該瘻孔造設術用拡張器で貫通孔を拡張させる際に、該先端16での抵抗が少なくなる点で好ましく、該小径部材先端部9の先端16の内径17と同じであることが最も好ましい。なお、該小径部材先端部9の先端16の内径及び外径は、図2に示す該大径部材先端部5の先端12と同様なので、図2を参照する。   The small-diameter member distal end portion 9 has a conical shape whose outer diameter decreases toward the distal end. The inner diameter 17 of the tip 16 of the small-diameter member tip 9 is not particularly limited as long as the small-diameter member 7 (or the fistula construction expander 1) can slide along the guide wire. It is appropriately selected depending on the outer diameter of the guide wire. The clearance between the tip 16 of the small-diameter member tip 9 and the guide wire, that is, the difference between the outer diameter 17 of the tip 16 and the outer diameter of the guide wire is 0 to 0.2 mm, preferably 0.02. ~ 0.09 mm. Usually, a 0.035 "guide wire having an outer diameter of 0.89 mm is used as the guide wire. Therefore, when the 0.035" guide wire is used, the inner diameter 17 of the tip 16 of the small diameter member tip 9 is used. Is preferably 0.9 to 1.1 mm, particularly preferably 0.92 to 0.98 mm. Further, when the outer diameter 18 of the distal end 16 of the small diameter member distal end portion 9 is closer to the value of the inner diameter 17 of the distal end 16 of the small diameter member distal end portion 9, when the through hole is expanded by the fistula construction dilator. It is preferable in that resistance at the tip 16 is reduced, and most preferably the same as the inner diameter 17 of the tip 16 of the small diameter member tip 9. The inner diameter and outer diameter of the tip 16 of the small diameter member tip 9 are the same as the tip 12 of the large diameter member tip 5 shown in FIG.

該大径部材3の該大径部材胴体部4及び大径部材先端部5並びに該小径部材7の該小径部材胴体部8及び該小径部材先端部9の材質は、特に制限されないが、生体適合性に優れており、拡張時に潰れたり、座屈したりすることがなく、且つ滑り易い材質であることが好ましく、例えば、ポリテトラフルオロエチレン樹脂(PTFE樹脂)、ポリビニリデンジフルオライド樹脂(PVDF樹脂)、テトラフルオロエチレン・ヘキサフルオロプロピレン共重合体樹脂(FEP樹脂)等のフッ素樹脂が好ましい。また、塩化ビニル樹脂、ポリエチレン樹脂、ナイロン樹脂等は、該PTFE樹脂や該フッ素樹脂に比べ、強度が低い樹脂ではあるが、該大径部材3の該大径部材胴体部4及び大径部材先端部5並びに該小径部材7の該小径部材胴体部8及び該小径部材先端部9の厚みを選択することにより、使用されることが可能となる。なお、塩化ビニル樹脂、ポリエチレン樹脂、ナイロン樹脂等の樹脂が滑り難い場合には、塩化ビニル樹脂、ポリエチレン樹脂、ナイロン樹脂等の樹脂は、表面に親水性処理が施されることにより、使用されることが可能となる。また、該目盛2が、UV硬化型インクで印字された目盛である場合、該目盛2が印字される該大径部材胴体部4の材質が、ポリビニリデンジフルオライド樹脂であることが、予め表面処理を行わなくても印字できる点で好ましい。また、該大径部材3及び該小径部材7は、金属化合物を含有することができ、レーザーマーカーで印字する場合に、印字が鮮明になる点で、金属化合物を1〜20質量含有することが好ましく、金属化合物を3〜10質量%含有することが特に好ましい。また、該金属化合物としては、酸化ビスマスが好ましい。また、該金属化合物の種類を選択することにより、該目盛2の色を変化させることができるので、該金属化合物の種類を適宜選択することにより、該目盛2と該目盛2以外の大径部材3との区別を明確にすることができる。なお、該大径部材胴体部4と該大径部材先端部5は、一体成形されたものであっても、あるいは、円筒形状の部品と円錐形状の部品を接着させたものであってもよく、同様に、該小径部材胴体部8と該小径部材先端部9は、一体成形されたものであっても、あるいは、円筒形状の部品と円錐形状の部品を接着させたものであってもよい。   The materials of the large-diameter member body 4 and the large-diameter member tip 5 of the large-diameter member 3 and the small-diameter member body 8 and the small-diameter member tip 9 of the small-diameter member 7 are not particularly limited, but are biocompatible. It is preferable that the material is excellent in properties, does not crush or buckle when expanded, and is slippery. For example, polytetrafluoroethylene resin (PTFE resin), polyvinylidene difluoride resin (PVDF resin) ), A fluororesin such as tetrafluoroethylene / hexafluoropropylene copolymer resin (FEP resin) is preferable. Further, vinyl chloride resin, polyethylene resin, nylon resin, etc. are resins having lower strength than the PTFE resin and the fluororesin, but the large-diameter member body 4 of the large-diameter member 3 and the tip of the large-diameter member By selecting the thickness of the portion 5 and the small diameter member body portion 8 and the small diameter member distal end portion 9 of the small diameter member 7, it can be used. In addition, when resins such as vinyl chloride resin, polyethylene resin, and nylon resin are difficult to slide, resins such as vinyl chloride resin, polyethylene resin, and nylon resin are used by applying hydrophilic treatment to the surface. It becomes possible. When the scale 2 is a scale printed with UV curable ink, the material of the large-diameter member body portion 4 on which the scale 2 is printed is a polyvinylidene difluoride resin. This is preferable because printing can be performed without surface treatment. The large-diameter member 3 and the small-diameter member 7 can contain a metal compound. When printing with a laser marker, the large-diameter member 3 and the small-diameter member 7 contain 1 to 20 mass of the metal compound in that the printing becomes clear. It is particularly preferable that the metal compound is contained in an amount of 3 to 10% by mass. The metal compound is preferably bismuth oxide. Moreover, since the color of the scale 2 can be changed by selecting the type of the metal compound, the large diameter member other than the scale 2 and the scale 2 can be selected by appropriately selecting the type of the metal compound. The distinction from 3 can be made clear. The large-diameter member body portion 4 and the large-diameter member tip portion 5 may be integrally formed or may be formed by bonding a cylindrical part and a conical part. Similarly, the small-diameter member body portion 8 and the small-diameter member distal end portion 9 may be integrally formed, or a cylindrical part and a conical part may be bonded together. .

該大径部材3の末端には、該大径部材側コネクタ6が、該小径部材7の末端には、該小径部材側コネクタ10が付設されている。該大径部材側コネクタ6及び該小径部材側コネクタ10は、該貫通孔の拡張を行う際に、該小径部材側コネクタ10を該大径部材側コネクタ6に嵌合させることにより、該大径部材の内部に挿通された該小径部材7を、該大径部材3に固定するための部材である。該大径部材側コネクタ6及び該小径部材側コネクタ10の付設は任意であるが、該貫通孔の拡張を行う際に、該大径部材3及び該小径部材7が一体となるので、穿刺針の外径から該小径部材胴体部8の外径までの大きさへの貫通孔の拡張と、該小径部材胴体部8の外径から該大径部材胴体部4の外径までの大きさへの貫通孔の拡張とを、連続して行えるので、手術時間が短縮できる点で、該大径部材側コネクタ6及び該小径部材側コネクタ10が付設されていることが好ましい。また、その場合、該大径部材側コネクタ6及び該小径部材側コネクタ10には、ロック機構が付いていることが特に好ましい。   The large diameter member side connector 6 is attached to the end of the large diameter member 3, and the small diameter member side connector 10 is attached to the end of the small diameter member 7. The large-diameter member-side connector 6 and the small-diameter member-side connector 10 are configured so that the large-diameter member-side connector 10 is fitted into the large-diameter member-side connector 6 when the through-hole is expanded. This is a member for fixing the small diameter member 7 inserted into the member to the large diameter member 3. The large-diameter member-side connector 6 and the small-diameter member-side connector 10 can be arbitrarily attached. However, when the through-hole is expanded, the large-diameter member 3 and the small-diameter member 7 are integrated. Expansion of the through hole from the outer diameter of the small-diameter member body portion 8 to the outer diameter of the small-diameter member body portion 8, and the size from the outer diameter of the small-diameter member body portion 8 to the outer diameter of the large-diameter member body portion 4 It is preferable that the large-diameter member-side connector 6 and the small-diameter member-side connector 10 are attached in that the operation time can be shortened. In this case, the large-diameter member side connector 6 and the small-diameter member side connector 10 are particularly preferably provided with a lock mechanism.

また、症例の違い、あるいは、術者の好みにより、先ず、穿刺針で形成された直後の貫通孔に、該小径部材7のみを挿入し、該穿刺針の外径から該小径部材胴体部8の外径までの大きさへの貫通孔の拡張を行い、次いで、該小径部材7の位置を固定して、該大径部材3を該貫通孔へ挿入し、該小径部材胴体部8の外径から該大径部材胴体部4の外径までの大きさへの拡張を行うことができ、この場合は、該大径部材側コネクタ6及び該小径部材側コネクタ10は必要ない。   Further, depending on the case or the preference of the operator, first, only the small diameter member 7 is inserted into the through-hole immediately after being formed with the puncture needle, and the small diameter member body portion 8 is inserted from the outer diameter of the puncture needle. The through-hole is expanded to a size up to the outer diameter of the small-diameter member, then the position of the small-diameter member 7 is fixed, the large-diameter member 3 is inserted into the through-hole, and the small-diameter member body portion 8 is Expansion from the diameter to the outer diameter of the large-diameter member body portion 4 can be performed. In this case, the large-diameter member-side connector 6 and the small-diameter member-side connector 10 are not necessary.

また、該大径部材3及び該小径部材7は、あらかじめ接着されているものであってもよい。   The large diameter member 3 and the small diameter member 7 may be bonded in advance.

該大径部材側コネクタ6及び該小径部材側コネクタ10は、圧入固定や接着固定等により付設されるため、加工性が良く且つ硬化剤等が接触してもクラックが発生しない程度の耐薬品性が必要である。該大径部材側コネクタ6及び該小径部材側コネクタ10の材質としては、特に制限されないが、硬質塩化ビニル樹脂等の硬質プラスチックが好ましい。   The large-diameter member-side connector 6 and the small-diameter member-side connector 10 are provided by press-fit fixing, adhesive fixing, or the like, so that the workability is good and the chemical resistance is such that cracks do not occur even when contacting with a curing agent or the like. is required. The material of the large diameter member side connector 6 and the small diameter member side connector 10 is not particularly limited, but is preferably a hard plastic such as a hard vinyl chloride resin.

該小径部材7を該大径部材3に挿通させ、該大径部材側コネクタ6及び該小径部材側コネクタ10で、該小径部材7を該大径部材3に固定した状態では、該小径部材7の一部が、該大径部材先端部5の先端12から突出している。該大径部材先端部5の先端12から突出している該小径部材7の長さ19は、特に制限されないが、好ましくは5〜200mm、特に好ましくは10〜60mmである。該長さ19が、上記範囲未満だと、ガイドワイヤーに誘導されて湾曲するだけの柔軟性が乏しくなり易く、胃壁を突き刺してしまう可能性がある。なお、柔軟な材質を選択することによって、該長さ19が、上記範囲未満であっても、胃壁を損傷することを防ぐことができ、このような柔軟な材質としては、エチレン−テトラフルオロエチレン共重合体(ETFE)、フルオロエチレン−フルオロプロピレン共重合体(FEP)、ポリテトラフルオロエチレン(PTFE)等が挙げられる。また、該長さ19が上記範囲を超えると、作業性が悪くなり易い。   In a state where the small diameter member 7 is inserted into the large diameter member 3 and the small diameter member 7 is fixed to the large diameter member 3 with the large diameter member side connector 6 and the small diameter member side connector 10, the small diameter member 7 Part of the large-diameter member protrudes from the tip 12 of the large-diameter member tip 5. The length 19 of the small-diameter member 7 protruding from the tip 12 of the large-diameter member tip 5 is not particularly limited, but is preferably 5 to 200 mm, particularly preferably 10 to 60 mm. If the length 19 is less than the above range, the flexibility to bend by being guided by the guide wire tends to be poor, and the stomach wall may be pierced. By selecting a flexible material, it is possible to prevent the stomach wall from being damaged even if the length 19 is less than the above range. As such a flexible material, ethylene-tetrafluoroethylene can be used. Examples thereof include a copolymer (ETFE), a fluoroethylene-fluoropropylene copolymer (FEP), and polytetrafluoroethylene (PTFE). On the other hand, when the length 19 exceeds the above range, workability tends to deteriorate.

図1中の該瘻孔造設術用拡張器1は、該大径部材3及び該小径部材7、すなわち、胴体部の外径が異なる2つの部材により構成されるので、該瘻孔造設術用拡張器1を用いる場合は、2段階で該貫通孔の拡張が行われるが、胴体部の外径が異なる部材の数は、特に制限はない。   1 is composed of the large-diameter member 3 and the small-diameter member 7, that is, two members having different outer diameters of the body portion. When 1 is used, the through hole is expanded in two stages, but the number of members having different outer diameters of the body portion is not particularly limited.

例えば、胴体部の外径が、該大径部材3の胴体部の外径と該小径部材7の胴体部の外径との間の大きさとなる中径部材を用意し、該大径部材3に該中径部材を挿通し、該中径部材に該該小径部材7を部材を挿通して、瘻孔造設術用拡張器を構成することができ、該瘻孔造設術用拡張器によれば、3段階で該貫通孔の拡張が行われる。この場合、該瘻孔造設術用拡張器は、大径部材、中径部材及び小径部材からなる瘻孔造設術用拡張器であって、該大径部材は、目盛が付されている円筒形状の大径部材胴体部、先端に向かって径が小さくなっている大径部材先端部及び該大径部材胴体部の末端に付設されている大径部材側コネクタからなり、該中径部材は、円筒形状の中径部材胴体部、先端に向かって径が小さくなっている中径部材先端部、及び該中径部材胴体部の末端に付設されている中径部材側コネクタからなり、該小径部材は、円筒形状の小径部材胴体部、先端に向かって径が小さくなっている小径部材先端部、及び該小径部材胴体部の末端に付設されている小径部材側コネクタからなる。   For example, an intermediate diameter member is prepared in which the outer diameter of the body portion is between the outer diameter of the body portion of the large diameter member 3 and the outer diameter of the body portion of the small diameter member 7. The medium diameter member is inserted into the medium diameter member, and the small diameter member 7 is inserted into the medium diameter member to form a fistula construction dilator. According to the fistula construction dilator, The through hole is expanded in three stages. In this case, the fistula dilator is a fistula dilator composed of a large-diameter member, a medium-diameter member, and a small-diameter member, and the large-diameter member has a large cylindrical shape with a scale. It consists of a diameter member body part, a large diameter member tip part whose diameter decreases toward the tip, and a large diameter member side connector attached to the end of the large diameter member body part. Medium-diameter member body, a medium-diameter member tip portion whose diameter decreases toward the tip, and a medium-diameter member-side connector attached to the end of the medium-diameter member body portion, the small-diameter member, A cylindrical small-diameter member body portion, a small-diameter member tip portion whose diameter decreases toward the tip portion, and a small-diameter member-side connector attached to the end of the small-diameter member body portion.

なお、部材の数が複数の場合、目盛が付される部材は、どの部材であってもよいが、該目盛が、胴体部の外径が最も大きい部材の胴体部に付されていることが、手術における作業性が高くなる点及びカテーテルを留置する直前に瘻孔長の測定を行うので、カテーテルを留置する際の状態に最も近い状態で瘻孔長の測定が行える点で好ましい。   In addition, when there are a plurality of members, the member to which the scale is attached may be any member, but the scale is attached to the body portion of the member having the largest outer diameter of the body portion. Since the fistula length is measured immediately before the catheter is placed, the fistula length can be measured in a state closest to the state when the catheter is placed.

また、例えば、該大径部材3の該大径部材先端部4の先端12の内径を、該ガイドワイヤの外径と同一又は若干大きくすることにより、1つの部材で瘻孔造設術用拡張器を構成することもでき、該瘻孔造設術用拡張器によれば、1段階で該貫通孔の拡張が行われる。この場合、該瘻孔造設術用拡張器は、目盛が付されている円筒形状の胴体部及び先端に向かって径が小さくなっている先端部からなる。   Further, for example, by making the inner diameter of the distal end 12 of the large-diameter member distal end portion 4 of the large-diameter member 3 the same as or slightly larger than the outer diameter of the guide wire, the dilator for fistula construction operation can be formed with one member. According to the fistula construction dilator, the through-hole is expanded in one step. In this case, the expander for fistula construction includes a cylindrical body portion with a scale and a tip portion whose diameter decreases toward the tip.

すなわち、本発明の瘻孔造設術用拡張器は、胴体部に目盛を有する瘻孔造設術用拡張器である。   That is, the fistula expansion device for fistula construction of the present invention is a fistula expansion device having a scale on the body part.

次に、本発明の瘻孔造設術用拡張器を用いる経皮的内視鏡胃瘻造設術(PEG)について説明する。本発明の経皮的内視鏡胃瘻造設術は、胃内に内視鏡を挿入しながら、(1)腹壁と胃壁とを固定する工程(以下、第1工程とも記載する。)、(2)腹壁及び胃壁に穿刺針を刺し、貫通孔を形成する工程(以下、第2工程とも記載する。)、(3)貫通孔にガイドワイヤを挿入する工程(以下、第3工程とも記載する。)、(4)ガイドワイヤに沿って、拡張器を貫通孔に挿入し、貫通孔の径を拡張して瘻孔を形成する工程(以下、拡張工程とも記載する。)、(5)瘻孔長を測定する工程(以下、瘻孔長測定工程とも記載する。)、(6)ガイドワイヤに沿って、カテーテルを瘻孔に挿入する工程(以下、第6工程とも記載する。)、(7)ガイドワイヤを抜去(以下、第7工程とも記載する。)する工程からなる。   Next, a percutaneous endoscopic gastrostomy (PEG) using the dilator for fistula construction according to the present invention will be described. In the percutaneous endoscopic gastrostomy of the present invention, (1) a step of fixing the abdominal wall and the stomach wall while inserting the endoscope into the stomach (hereinafter also referred to as the first step), (2). ) A step of piercing the abdominal wall and stomach wall to form a through hole (hereinafter also referred to as a second step), (3) a step of inserting a guide wire into the through hole (hereinafter also referred to as a third step). ), (4) A step of inserting a dilator into the through hole along the guide wire and expanding the diameter of the through hole to form a fistula (hereinafter also referred to as an expansion step), (5) A fistula length. A step of measuring (hereinafter also referred to as a fistula length measuring step), (6) a step of inserting a catheter into the fistula along the guide wire (hereinafter also referred to as a sixth step), and (7) a guide wire. It consists of a process of removing (hereinafter also referred to as a seventh process).

該第1工程では、患者の胃内に内視鏡を挿入し送気を十分行い、腹壁と胃壁とを密着させる。次に、内視鏡からの透過光により胃の位置を確認し、腹部皮膚を消毒、局所麻酔を行う。続いて、その部位において、腹壁と胃壁の相対位置のずれを防止するため、胃壁腹壁固定を行う。この胃壁腹壁固定の近傍に、メスで小切開を加えておく。この部位が、カテーテルの挿入予定部位となる。また、更に、メスで小切開した部位では、金属鉗子を用いて筋層剥離することもできる。金属鉗子を用いて筋層剥離することにより、後の工程で、瘻孔造設術用拡張器及びカテーテルを挿入し易くなる。   In the first step, an endoscope is inserted into the patient's stomach and air is supplied sufficiently to bring the abdominal wall and stomach wall into close contact. Next, the position of the stomach is confirmed by transmitted light from the endoscope, the abdominal skin is disinfected, and local anesthesia is performed. Subsequently, in order to prevent the relative position between the abdominal wall and the stomach wall from shifting at that site, gastric wall abdominal wall fixation is performed. A small incision is made with a scalpel in the vicinity of the stomach wall and abdominal wall fixation. This site is a catheter insertion planned site. Furthermore, at the site where a small incision is made with a scalpel, the muscle layer can be peeled off using metal forceps. By peeling the muscle layer using the metal forceps, it becomes easy to insert the fistula construction dilator and the catheter in a later step.

該第2工程では、小切開部位に中空針又はシース付き針等を腹壁、胃壁の順に貫通させ、貫通孔を形成させる。   In the second step, a hollow needle or a sheathed needle or the like is passed through the small incision site in the order of the abdominal wall and the stomach wall to form a through hole.

該第3工程では、該貫通孔に、中空針又はシースの内腔を経て、ガイドワイヤを胃内まで挿入する。挿入終了後、ガイドワイヤを残したまま、中空針又はシース付き針を患者から抜去しておく。以降の操作中にガイドワイヤが意に反して引き抜かれることが無いように、ガイドワイヤのうち、十分に長い長さが胃内に挿入される。また、体外に出ているガイドワイヤを鉗子やテープ等で、体表又はドレープに固定することによって、ガイドワイヤが意に反して引き抜かれることを防ぐこともできる。   In the third step, the guide wire is inserted into the stomach through the hollow needle or the lumen of the sheath. After the insertion is completed, the hollow needle or the sheathed needle is removed from the patient with the guide wire remaining. A sufficiently long length of the guide wire is inserted into the stomach so that the guide wire is not pulled out unexpectedly during the subsequent operation. Moreover, it is possible to prevent the guide wire from being pulled out unintentionally by fixing the guide wire that has come out of the body to the body surface or drape with forceps, tape, or the like.

該拡張工程では、本発明の瘻孔造設術用拡張器を用いて、該貫通孔を拡張する。該拡張工程の形態例として、図1に示す該瘻孔造設術用拡張器1を用いる場合について説明する。先ず、該大径部材3に該小径部材7を挿通し、該大径部材3と該小径部材7をコネクタで固定する。次いで、該ガイドワイヤを、該瘻孔造設術用拡張器1の該小径部材7に、該小径部材7の先端側から挿通する。次いで、該ガイドワイヤに沿って、該瘻孔造設術用拡張器1を、該貫通孔に挿入し、該貫通孔の拡張を行う。   In the expansion step, the through-hole is expanded using the fistula construction expander of the present invention. As an example of the expansion process, the case where the fistula construction expander 1 shown in FIG. 1 is used will be described. First, the small diameter member 7 is inserted into the large diameter member 3, and the large diameter member 3 and the small diameter member 7 are fixed by a connector. Next, the guide wire is inserted into the small diameter member 7 of the fistula construction dilator 1 from the distal end side of the small diameter member 7. Next, the fistula construction dilator 1 is inserted into the through hole along the guide wire to expand the through hole.

該瘻孔長測定工程について、図3を参照して説明する。図3は、本発明の瘻孔造設術用拡張器を用いる瘻孔長測定工程を説明する模式図であり、該瘻孔造設術用拡張器の挿入方向に対して平行な面で切ったときの図である。図3中(III−1)は、該拡張工程が終わった直後の様子を示す模式図であり、図3中(III−2)は、瘻孔長測定時の様子を示す模式図である。なお、説明の都合上、該瘻孔造設術用拡張器については、断面図ではなく、側面図で示した。   The hole length measuring step will be described with reference to FIG. FIG. 3 is a schematic diagram for explaining a fistula length measuring step using the fistula construction dilator according to the present invention, and is a view when cut along a plane parallel to the insertion direction of the fistula dilator. is there. (III-1) in FIG. 3 is a schematic diagram showing a state immediately after the expansion step is finished, and (III-2) in FIG. 3 is a schematic diagram showing a state at the time of measuring the fistula length. For convenience of description, the fistula construction dilator is shown in a side view, not a cross-sectional view.

該瘻孔造設術用拡張器20を貫通孔28に挿入して、該拡張工程を行った直後は、該腹壁及び胃壁23は、該瘻孔造設術用拡張器20の胴体部の任意の部分に存在する。この時、基点(ゼロ点)22の位置と胃壁の内側25の位置は合っていない(III−1)。そこで、胃内26に挿入された内視鏡21で観察しながら、該瘻孔造設術用拡張器20を更に押し込んで又は引き抜いて、該基点22の位置と該胃壁の内側25の位置を合わせる(ゼロ点調節)(III−2)。そして、体外側27から目盛24を目視し、瘻孔長を測定する。このようにして、該瘻孔長測定工程を行う。そして、瘻孔長の測定後、該瘻孔造設術用拡張器を抜去する。なお、本発明において、胃壁の内側とは、胃内部側の胃壁の表面を指す。   Immediately after inserting the dilator 20 for fistula construction into the through-hole 28 and performing the dilation step, the abdominal wall and stomach wall 23 are present in any part of the trunk of the dilator 20 for fistula construction. To do. At this time, the position of the base point (zero point) 22 and the position of the inner side 25 of the stomach wall do not match (III-1). Therefore, while observing with the endoscope 21 inserted into the stomach 26, the fistula construction dilator 20 is further pushed or pulled out to align the position of the base point 22 with the position of the inner side 25 of the stomach wall ( Zero point adjustment) (III-2). And the scale 24 is visually observed from the body outer side 27, and the fistula length is measured. In this way, the hole length measuring step is performed. Then, after measuring the fistula length, the fistula construction dilator is removed. In the present invention, the inner side of the stomach wall refers to the surface of the stomach wall on the stomach inner side.

該第6工程では、該ガイドワイヤに沿って、造設された瘻孔に、カテーテルを挿入して、該造設された瘻孔に、該カテーテルを留置する。   In the sixth step, a catheter is inserted into the constructed fistula along the guide wire, and the catheter is placed in the constructed fistula.

該第7工程では、該ガイドワイヤを体外側に引張り、胃内から抜去する。   In the seventh step, the guide wire is pulled outside the body and removed from the stomach.

なお、該第1工程、該第2工程、該第3工程、該第6工程及び該第7工程は、特に制限されず、従来の経皮的内視鏡胃瘻造設術で行われている方法と同様の方法で各工程を行うことができる。また、該拡張工程は、瘻孔造設術用拡張器として、本発明の瘻孔造設術用拡張器を用いる以外は、従来の経皮的内視鏡胃瘻造設術で行われている方法と同様の方法で、該拡張工程を行うことができる。   The first step, the second step, the third step, the sixth step and the seventh step are not particularly limited, and are performed by a conventional percutaneous endoscopic gastrostomy. Each step can be performed in the same manner as described above. In addition, the dilation step is a method similar to the method performed in the conventional percutaneous endoscopic gastrostomy, except that the dilator for fistula construction according to the present invention is used as the dilator for fistula construction. The expansion step can be performed.

すなわち、本発明の経皮的内視鏡胃瘻造設術は、本発明の瘻孔造設術用拡張器を用いて、貫通孔の拡張を行う拡張工程、及び胃内に挿入されている内視鏡で観察しながら、本発明の瘻孔造設術用拡張器に付されている基点と胃壁の内側を合わせ、次いで、体外の目盛を目視して瘻孔長を測定する瘻孔長測定工程を有する経皮的内視鏡胃瘻造設術である。   That is, the percutaneous endoscopic gastrostomy according to the present invention includes an expansion process for expanding a through-hole using the fistula expansion device according to the present invention, and an endoscope inserted into the stomach. While observing, the base point attached to the dilator for fistula construction of the present invention and the inner side of the stomach wall are aligned, and then the percutaneous internal process has a fistula length measurement step of measuring the fistula length by visually observing the scale outside the body Endoscopic gastrostomy.

このように、本発明の瘻孔造設術用拡張器によれば、経皮的内視鏡胃瘻造設術において、前段の拡張工程で用いた瘻孔造設術用拡張器を抜去せず、そのまま用い、且つ既に胃内に挿入されている内視鏡で、該瘻孔造設術用拡張器の基点と胃壁の内側を合わせるという簡便な操作で、瘻孔長の測定を行うことができるので、手術時間の短縮ができる。また、本発明の瘻孔造設術用拡張器によれば、瘻孔長測定用の専用器具を用いることなく、瘻孔長の測定を行えるので、処理具の部品点数を削減できる。   Thus, according to the fistula expander of the present invention, in the percutaneous endoscopic gastrostomy, the fistula expander used in the previous expansion step is not removed, and is used as it is. With the endoscope already inserted in the stomach, the fistula length can be measured by a simple operation of aligning the base point of the dilator for fistula construction and the inside of the stomach wall. it can. In addition, according to the expander for fistula construction according to the present invention, the fistula length can be measured without using a dedicated instrument for fistula length measurement, so that the number of parts of the processing tool can be reduced.

本発明によれば、患者の負担、術者のストレスが少なく且つコストが低い瘻孔長測定器(瘻孔造設術用拡張器兼瘻孔長測定器)を提供できる。   According to the present invention, it is possible to provide a fistula length measuring instrument (expansion and fistula length measuring instrument for fistula construction) with less burden on the patient, less stress on the operator, and lower cost.

1、20 瘻孔造設術用拡張器
2、24 目盛
3 大径部材
4 大径部材胴体部
5 大径部材先端部
6 大径部材側コネクタ
7 小径部材
8 小径部材胴体部
9 小径部材先端部
10 小径部材側コネクタ
11、22 基点(ゼロ点)
12 大径部材先端部の先端
13 大径部材先端部の先端の内径
14 大径部材先端部の先端の外径
15 大径部材の全長
16 小径部材先端部の先端
17 小径部材先端部の先端の内径
18 小径部材先端部の先端の外径
19 突出している小径部材の長さ
21 内視鏡
23 腹壁及び胃壁
25 胃壁の内側
26 胃内
27 体外側
28 貫通孔
DESCRIPTION OF SYMBOLS 1,20 Fistula expansion device 2 and 24 Scale 3 Large diameter member 4 Large diameter member body part 5 Large diameter member tip part 6 Large diameter member side connector 7 Small diameter member 8 Small diameter member body part 9 Small diameter member tip part 10 Small diameter Member side connector 11, 22 Base point (zero point)
12 Tip of large diameter member tip 13 Inner diameter of tip of large diameter member tip 14 Outer diameter of tip of large diameter member tip 15 Overall length of large diameter member 16 Tip of tip of small diameter member 17 Tip of tip of small diameter member Inner diameter 18 Outer diameter 19 at the tip of the small diameter member The length of the protruding small diameter member
21 Endoscope 23 Abdominal wall and stomach wall 25 Inside the stomach wall 26 Inside the stomach 27 Outside the body 28 Through-hole

Claims (6)

胴体部に目盛を有することを特徴とする瘻孔造設術用拡張器。   An expander for fistula construction, characterized by having a scale on the body. 前記目盛が、レーザーマーカーで印字された目盛であることを特徴とする請求項1記載の瘻孔造設術用拡張器。   The dilator for fistula construction according to claim 1, wherein the scale is a scale printed with a laser marker. 前記目盛が、UV硬化型インクで印字された目盛であることを特徴とする請求項1記載の瘻孔造設術用拡張器。   The dilator for fistula construction according to claim 1, wherein the scale is a scale printed with UV curable ink. 前記目盛が、シリコーンインクで印字された目盛であることを特徴とする請求項1記載の瘻孔造設術用拡張器。   The dilator for fistula construction according to claim 1, wherein the scale is a scale printed with silicone ink. 前記瘻孔造設術用拡張器の材質が、ポリビニリデンジフルオライドであることを特徴とする請求項3又は4いずれか1項記載の瘻孔造設術用拡張器。   5. The fistula construction dilator according to claim 3, wherein a material of the fistula construction dilator is polyvinylidene difluoride. 前記瘻孔造設術用拡張器の材質が、プラズマ処理されたポリビニリデンジフルオライドであることを特徴とする請求項3又は4いずれか1項記載の瘻孔造設術用拡張器。   5. The fistula construction dilator according to claim 3, wherein the fistula dilator is made of plasma-treated polyvinylidene difluoride.
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