JP2009225895A - Fistula catheter - Google Patents

Fistula catheter Download PDF

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JP2009225895A
JP2009225895A JP2008072587A JP2008072587A JP2009225895A JP 2009225895 A JP2009225895 A JP 2009225895A JP 2008072587 A JP2008072587 A JP 2008072587A JP 2008072587 A JP2008072587 A JP 2008072587A JP 2009225895 A JP2009225895 A JP 2009225895A
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fistula catheter
tubular member
indwelling
fistula
catheter
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Yutaka Suzuki
裕 鈴木
Yasumasa Koshiro
康雅 小城
Yukihiko Sakaguchi
幸彦 坂口
Zenetsu Suzuki
善悦 鈴木
Keiji Kamata
圭司 鎌田
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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 a fistula catheter, low invasive to a patient because the resistance when the catheter is transdermally inserted into the internal organs from outside the body or removed from the internal organs can be reduced, allowing an operator to safely and easily insert/remove the catheter, and capable of being inexpensively manufactured. <P>SOLUTION: In the fistula catheter, a tubular member 2 having a lumen 21 for feeding a liquid substance and an internal indwelling part 3 attached to the distal end portion of the tubular member 2 and for retaining and fixing the fistula catheter within the internal organs are integrally formed. The durometer hardness of the tubular member 2 is higher than that of the internal indwelling part 3. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

本発明は、瘻孔用カテーテルに関するものである。   The present invention relates to a fistula 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を実施する為に瘻孔用カテーテルが使用される。
瘻孔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、栄養剤又は薬液等の液状物質を体外から胃内へ導入するルーメンを内部に有し瘻孔の壁面に沿って伸びる管状部材と、この管状部材の先端部に付設され、管状部材の径方向外側に拡径された張り出し状の体内留置部から構成されている。 As a method of administering nutrition to patients who cannot take nutrition orally, enteral nutrition management by percutaneous endoscopic gastrostomy (hereinafter abbreviated as “PEG”) is frequently performed. A fistula catheter is used to perform this PEG.
There are various types of fistula catheters depending on the placement technique, patient condition, period of use, operability of caregivers, etc. Generally, a lumen for introducing liquid substances such as nutrients or chemicals from outside the body into the stomach is used. It has a tubular member inside and extending along the wall surface of the fistula, and an overhanging indwelling portion attached to the distal end portion of the tubular member and expanded radially outward of the tubular member.

上記瘻孔用カテーテルは、通常、留置による劣化や汚れの為、一定期間後、新しいカテーテルに交換されるが、瘻孔造設後の初期留置を含め、患者の瘻孔を介して瘻孔用カテーテルの挿入、抜去が繰り返し実施される。
特に非バルーン型のカテーテルでは、伸展具等を用いて、張り出した状態の体内留置部に外力を加え直線状態に縮径し、挿入抵抗、抜去抵抗を低減させる技術が開示されている(例えば、特許文献１参照)。
さらに、非バルーン型のカテーテルで、管状部材と体内留置部の接合部から体内留置部先端に向かって、体内留置部の肉厚を徐々に増すことで、挿入抵抗を低減させる技術が開示されている（例えば、特許文献２参照）。また、体内留置部を帯状部と切欠きの付設された膜状部で形成し、この切欠きを基点に折り畳み、挿入抵抗、抜去抵抗を低減させる技術も開示されている（例えば、特許文献３参照）。
また、チューブの潰れ（キンク）防止として、コイルスプリングを管状部材に埋め込んだ瘻孔用カテーテルの技術も開示されている（例えば、特許文献４参照）。 The fistula catheter is usually replaced with a new catheter after a certain period of time due to indwelling deterioration and contamination, including insertion of the fistula catheter through the patient's fistula, including initial placement after fistula construction, The extraction is repeated.
Particularly for non-balloon type catheters, a technique for reducing the insertion resistance and extraction resistance by applying an external force to the in-vivo indwelling portion in a stretched state and reducing the diameter to a linear state is disclosed (for example, (See Patent Document 1).
Further, a technique for reducing insertion resistance by gradually increasing the thickness of the indwelling portion from the joint portion of the tubular member and the indwelling portion toward the distal end of the indwelling portion with a non-balloon type catheter is disclosed. (For example, refer to Patent Document 2). Also disclosed is a technique in which the indwelling part is formed of a film-like part provided with a band-like part and a notch, and is folded around the notch to reduce insertion resistance and removal resistance (for example, Patent Document 3). reference).
In addition, a fistula catheter technique in which a coil spring is embedded in a tubular member is also disclosed as a tube kink prevention (see, for example, Patent Document 4).

米国特許４８６３４３８号明細書US Pat. No. 4,863,438 米国特許５３３６２０３号明細書US Pat. No. 5,336,203 特開２００６−２９６７９４号公報JP 2006-296794 A 特許第３６７５６５０号明細書Japanese Patent No. 3675650

上記のような従来の瘻孔用カテーテルは、伸展具等を用いて、張り出した状態の体内留置部に外力を加え直線状態に縮径するものの、同時に管状部材も無意味に伸ばしてしまい、最も患者に侵襲を与える体内留置部に効果的に外力を伝えることができないという問題点があった。
本発明は上記事情に鑑みてなされたものであり、体外から経皮的にカテーテルを体内臓器に挿入、抜去する際の抵抗を軽減できることで、患者に対しては低侵襲であり、且つ処置者はカテーテルを安全・容易に挿入、抜去することができると共に、安価に製造可能な瘻孔用カテーテルを提供することにある。 Although the conventional fistula catheter as described above uses an extension tool or the like to apply an external force to the protruding in-vivo indwelling portion and reduce the diameter to a linear state, at the same time, the tubular member also extends meaninglessly, and is the most patient There is a problem that external force cannot be effectively transmitted to the indwelling part that invades the body.
The present invention has been made in view of the above circumstances, and can reduce resistance when a catheter is inserted into and removed from a body organ percutaneously from the outside of the body. An object of the present invention is to provide a fistula catheter that can be inserted and removed safely and easily and can be manufactured at low cost.

このような目的は、下記（１）から（９）に記載の本発明により達成される。
（１）栄養剤又は薬剤等の液状物質を体外から体内臓器へ経皮的に補給する瘻孔用カテーテルであって、
前記液状物質を補給する管腔を有する管状部材と、
前記管状部材の先端部に付設され、体内臓器内にて前記瘻孔用カテーテルを留置固定する体内留置部とが一体的に成形されていると共に、
前記管状部材のジュロメーター硬度が前記体内留置部より高いことを特徴とする瘻孔用カテーテル。
（２）前記体内留置部のジュロメーター硬度は、Ａスケールで３０以上、６０以下である（１）に記載の瘻孔用カテーテル。
（３）前記管状部材のジュロメーター硬度は、Ａスケールで５０以上、７５以下である（１）に記載の瘻孔用カテーテル。
（４）前記体内留置部は７５０％以上の切断時伸びを示す樹脂で構成されることを特徴とする（１）または（２）に記載の瘻孔用カテーテル。
（５）前記管状部材の基端側には、体外固定部が付設されている（１）または（３）に記載の瘻孔用カテーテル。
（６）前記体内留置部の先端部には、体外と体内臓器間をガイドワイヤが挿通する為のガイドワイヤ挿通孔が付設されている（１）、（２）、（４）のいずれかに記載の瘻孔用カテーテル。
（７）前記体内留置部の先端部内面には、補強部材が付設されている（１）、（２）、（４）、（６）のいずれかに記載の瘻孔用カテーテル。
（８）前記補強部材がメッシュ状の金属である（７）に記載の瘻孔用カテーテル。
（９）更に前記管状部材の内腔には、前記液状物質が体内臓器から前記管状部材の内腔を経て体外へ逆流することを防ぐ一方弁が付設されている（１）、（３）、（５）のいずれかに記載の瘻孔用カテーテル。 Such an object is achieved by the present invention described in the following (1) to (9).
(1) A fistula catheter for transcutaneously replenishing a liquid substance such as a nutrient or drug from outside the body to a body organ,
A tubular member having a lumen for replenishing the liquid substance;
Attached to the distal end of the tubular member and integrally formed with an indwelling part for indwelling and fixing the fistula catheter in a body organ,
A fistula catheter, wherein the tubular member has a durometer hardness higher than that of the indwelling portion.
(2) The fistula catheter according to (1), wherein the durometer hardness of the indwelling portion is 30 or more and 60 or less on an A scale.
(3) The fistula catheter according to (1), wherein the durometer hardness of the tubular member is 50 or more and 75 or less on an A scale.
(4) The fistula catheter according to (1) or (2), wherein the in-vivo indwelling portion is made of a resin exhibiting elongation at the time of cutting of 750% or more.
(5) The fistula catheter according to (1) or (3), wherein an extracorporeal fixing part is attached to the proximal end side of the tubular member.
(6) A guide wire insertion hole through which the guide wire is inserted between the outside of the body and the internal organs is attached to the distal end portion of the indwelling portion in any one of (1), (2), and (4) The fistula catheter as described.
(7) The fistula catheter according to any one of (1), (2), (4), and (6), wherein a reinforcing member is attached to the inner surface of the distal end portion of the indwelling portion.
(8) The fistula catheter according to (7), wherein the reinforcing member is a mesh metal.
(9) Further, the lumen of the tubular member is provided with a one-way valve for preventing the liquid substance from flowing back from the body organ through the lumen of the tubular member to the outside of the body (1), (3), The fistula catheter according to any one of (5).

本発明によれば、体外から経皮的にカテーテルを体内臓器に挿入、抜去する際の抵抗を軽減できることで、患者に対しては低侵襲であり、且つ処置者はカテーテルを安全・容易に挿入、抜去することができると共に、安価に製造可能な瘻孔用カテーテルを提供することができる。   According to the present invention, it is possible to reduce resistance when a catheter is inserted into and removed from a body organ percutaneously from outside the body, so that it is minimally invasive to a patient, and a treatment person can insert the catheter safely and easily Thus, it is possible to provide a fistula catheter that can be removed and manufactured at low cost.

以下、各構成要件について図面を用いて詳細に説明する。
図１は本発明の瘻孔用カテーテルの第一の実施形態を示す斜視図である。瘻孔用カテーテル１は、栄養剤又は薬剤等の液状物質を体外から体内臓器へ経皮的に補給する管腔２１を有する管状部材２と、管状部材２の先端部に付設され、体内臓器内にて瘻孔用カテーテル１を留置固定する体内留置部３とが一体的に成形されていると共に、上記管状部材２のジュロメーター硬度が上記体内留置部３よりも高いジュロメーター硬度で構成されている。 Hereinafter, each component will be described in detail with reference to the drawings.
FIG. 1 is a perspective view showing a first embodiment of a fistula catheter according to the present invention. The fistula catheter 1 is attached to a tubular member 2 having a lumen 21 for transcutaneously supplying a liquid substance such as a nutrient or a drug to the internal organs from outside the body, and attached to the distal end portion of the tubular member 2. The indwelling portion 3 for indwelling and fixing the fistula catheter 1 is integrally formed, and the durometer hardness of the tubular member 2 is higher than that of the indwelling portion 3.

図２に示すように、従来の瘻孔用カテーテルは管状部材２と体内留置部３とが同一硬度で成形、若しくは接着されているため、伸展具１０を用いて、張り出した状態の体内留置部３に外力を加え直線状態に縮径した時に、管状部材２もその軸方向に大幅に伸びてしまう（Ｌ１'＞Ｌ１）という問題点がある。
これに対し、本発明は管状部材２を体内留置部３に比べて硬く伸びにくい樹脂で構成することで、高い硬度の上記管状部材２がその軸方向に伸び始める前に、低い硬度の上記体内留置部３を上記管状部材２の軸方向に押し伸ばすことができ、より効果的に伸展具１０による外力を上記体内留置部３に伝えることが可能となる。
すなわち、伸展具１０の移動距離が同じ設定の場合、従来の瘻孔用カテーテルに比較し、本発明の構成では、上記管状部材２のその軸方向への伸びを抑え（Ｌ１''＜Ｌ１'）、上記体内留置部３を上記管状部材２の軸方向により長く伸ばすことができ（Ｌ２''＞Ｌ２'）、上記体内留置部３の直径をより縮径することが可能となる（Ｒ''＜Ｒ'）。これにより、瘻孔用のカテーテルの理想型と考えられるＲ''／Ｒ＝１（伸展時）に近づくことが可能となり、患者の瘻孔を介した瘻孔用カテーテル１の挿入、抜去抵抗が著しく軽減され、また処置者もスムーズに交換操作を実施でき、安全・容易な手技を実現できる。 As shown in FIG. 2, in the conventional fistula catheter, the tubular member 2 and the in-vivo indwelling portion 3 are molded or bonded with the same hardness. When an external force is applied to reduce the diameter to a linear state, the tubular member 2 also has a problem that the axial direction of the tubular member 2 is greatly extended (L 1 ′> L 1 ).
On the other hand, in the present invention, the tubular member 2 is made of a resin that is harder and less stretchable than the indwelling portion 3, so that the higher hardness of the tubular member 2 starts to extend in the axial direction before the lower hardness of the body. The indwelling part 3 can be pushed and extended in the axial direction of the tubular member 2, and the external force by the extender 10 can be transmitted to the in-vivo indwelling part 3 more effectively.
That is, when the moving distance of the extension tool 10 is set to be the same, the axial length of the tubular member 2 is suppressed (L1 ″ <L1 ′) in the configuration of the present invention as compared with the conventional fistula catheter. The indwelling portion 3 can be extended longer in the axial direction of the tubular member 2 (L2 ″> L2 ′), and the diameter of the indwelling portion 3 can be further reduced (R ″). <R '). This makes it possible to approach R ″ / R = 1 (during extension), which is considered to be an ideal type of fistula catheter, and the insertion and removal resistance of the fistula catheter 1 through the patient's fistula is significantly reduced. In addition, the treatment person can perform the replacement operation smoothly, and a safe and easy procedure can be realized.

管状部材２は体内留置部３のジュロメーター硬度よりも高い樹脂で構成されれば特に限定しないが、上記管状部材２のジュロメーター硬度は、Ａスケールで５０以上、７５以下であることが好ましい。上記体内留置部３のジュロメーター硬度は、Ａスケールで３０以上、６０以下であることが好ましく、特に好ましくは、上記範囲内で管状部材２と体内留置部３の硬度差をより大きくとることが好ましい。
管状部材２が上記範囲以上であると、患者の体表に出てくる部分が硬く、生活に支障をきたし、患者に不快感を与えてしまう。上記範囲以下であると、管状部材２の潰れ（キンク）のリスクが上がり、栄養剤等の通過に影響を与える可能性が高くなる。
体内留置部３が上記範囲以上の硬度であると、伸展具１０の操作、すなわち体内留置部３を伸展する為に必要な力が大きくなり、処置者が片手で操作することが困難となってしまう。上記範囲以下であると、体内臓器内に瘻孔用カテーテル１を留置固定する能力（アンカー力）が低くなり、留置中の瘻孔からの不意な抜去（事故抜去）が発生するリスクが高くなる。 Although it will not specifically limit if the tubular member 2 is comprised with resin higher than the durometer hardness of the indwelling part 3, It is preferable that the durometer hardness of the said tubular member 2 is 50-75 in A scale. The durometer hardness of the indwelling portion 3 is preferably 30 or more and 60 or less on the A scale, and particularly preferably, the hardness difference between the tubular member 2 and the indwelling portion 3 is made larger within the above range. preferable.
If the tubular member 2 is in the above range or more, the portion appearing on the patient's body surface is hard, which interferes with life and gives the patient discomfort. If it is below the above range, the risk of crushing (kinking) the tubular member 2 increases, and the possibility of affecting the passage of nutrients and the like increases.
When the indwelling portion 3 has a hardness of the above range or more, the force required to operate the extension device 10, that is, to extend the indwelling portion 3, becomes large, and it becomes difficult for the operator to operate with one hand. End up. If it is less than the above range, the ability (anchor force) of indwelling and fixing the fistula catheter 1 in the internal organ becomes low, and the risk of inadvertent removal (accident extraction) from the fistula during placement increases.

管状部材２は、栄養剤又は薬剤等の液状物質を体外から体内臓器へ経皮的に補給する管腔２１を有せば、その形状は特に限定しない。患者の一般的な瘻孔のサイズに合わせて、５〜１０ｍｍの外径のラインナップを持つことが好ましい。   The shape of the tubular member 2 is not particularly limited as long as it has a lumen 21 for transcutaneously replenishing a liquid substance such as a nutrient or a drug from the outside of the body to the internal organ. It is preferable to have a lineup with an outer diameter of 5 to 10 mm in accordance with the size of a general fistula of a patient.

体内留置部３の形状は、非バルーン型で、伸展具１０で押し伸ばされて使用される瘻孔用カテーテルに一般的に用いられる形状であれば特に限定しない。マレコット型、ピラミッド型、ドーム型、Ｔ字型、お椀型のどの形状であっても、形状が同じもので比較すれば、従来の同一硬度の構成と本発明の構成ではその効果は十分確認できる為である。   The shape of the indwelling part 3 is not particularly limited as long as it is a non-balloon type and is generally used for a fistula catheter that is pushed and stretched by the extender 10. Even if it is a malecot type, pyramid type, dome type, T-shape, or bowl shape, the effect can be sufficiently confirmed in the conventional configuration of the same hardness and the configuration of the present invention when compared with the same shape. Because of that.

管状部材２と体内留置部３は一体的に成形されることが好ましい。一体的に成形されることで、一般的に行われている接着やインサート成形による接合よりも強度を確保でき、長期的な使用に優れ、また段差を無くすことができる為、留置中の患者の不快感を低減できる。その成形方法は特に限定しないが、二色成形などが実用的であり、接着等で形成されるものに比較し安価に製造することが可能となる。   The tubular member 2 and the indwelling portion 3 are preferably molded integrally. Because it is molded integrally, it can secure strength compared to bonding that is generally performed and bonding by insert molding, it is excellent for long-term use, and it can eliminate steps, so that the patient who is indwelling Discomfort can be reduced. The molding method is not particularly limited, but two-color molding or the like is practical, and can be manufactured at a lower cost than those formed by adhesion or the like.

さて、このような瘻孔用カテーテル１を構成する材料としては、例えば、ポリウレタン樹脂、シリコーンゴム等が挙げられる。体内留置部３は、伸展性がある材料であれば特に限定されないが、体内において組織反応性の少ないシリコーンゴムが好ましい。   Now, examples of the material constituting such a fistula catheter 1 include polyurethane resin and silicone rubber. The indwelling part 3 is not particularly limited as long as it is a material having extensibility, but silicone rubber having a low tissue reactivity in the body is preferable.

図３に瘻孔用カテーテル１に伸展具１０をセットした際の断面図を示す。
体内留置部３の先端部には、体外と体内臓器間を結ぶガイドワイヤを挿通する為のガイドワイヤ挿通孔４が付設されている。これにより、留置されていた瘻孔用カテーテル１に伸展具１０をセットし、伸展具１０のガイドワイヤ通路１１からガイドワイヤを挿入し、瘻孔用カテーテル１のガイドワイヤ挿通孔４を通ることで、ガイドワイヤによる体外と体内臓器間の連結が達成される。
したがって、瘻孔用カテーテル１の交換操作において、伸展具１０で伸展させた瘻孔用カテーテル１をガイドワイヤに沿って抜去し、次にガイドワイヤに沿って新しい瘻孔用カテーテル１を挿入するという一連の操作が可能となり、腹腔内への逸脱を防止し、確実に臓器内へ瘻孔用カテーテル１を挿入することができる。 FIG. 3 shows a cross-sectional view when the extension device 10 is set on the fistula catheter 1.
A guide wire insertion hole 4 is provided at the distal end of the indwelling portion 3 for inserting a guide wire connecting the outside of the body and the internal organs. Thereby, the extension tool 10 is set in the indwelling fistula catheter 1, the guide wire is inserted from the guide wire passage 11 of the extension tool 10, and the guide wire is inserted through the guide wire insertion hole 4 of the fistula catheter 1. A connection between the extracorporeal and internal organs by wires is achieved.
Therefore, in the replacement operation of the fistula catheter 1, a series of operations in which the fistula catheter 1 extended by the extension tool 10 is removed along the guide wire and then a new fistula catheter 1 is inserted along the guide wire. Therefore, the deviation into the abdominal cavity can be prevented, and the fistula catheter 1 can be reliably inserted into the organ.

ガイドワイヤ挿通孔４の直径は、使用するガイドワイヤの直径に合わせたものであれば特に限定しない。０．９〜１．５ｍｍであることが好ましく、特に０．９〜１．２ｍｍが好ましい。上記寸法範囲内であれば、特に０．０３５ｉｎｃｈ（インチ）のガイドワイヤの挿入性に優れる。   The diameter of the guide wire insertion hole 4 is not particularly limited as long as it matches the diameter of the guide wire to be used. 0.9 to 1.5 mm is preferable, and 0.9 to 1.2 mm is particularly preferable. If it is in the said dimension range, it is excellent in the insertability of a 0.035 inch (inch) guide wire especially.

体内留置部３はその先端部付近に、伸展具１０による外力が作用する当接部５を有し、当接部５は補強部材５１で補強されている。上記補強部材５１が付設されることで、上記体内留置部３に伸展具１０で外力を加えた時に、体内留置部３の先端の破損を防止でき、体内留置部３を縮径状態で患者の瘻孔から抜去、挿入する操作を安全且つ確実に実施できることとなる。   The indwelling part 3 has a contact part 5 on which an external force from the extension tool 10 acts in the vicinity of the tip part, and the contact part 5 is reinforced by a reinforcing member 51. By attaching the reinforcing member 51, when an external force is applied to the in-vivo indwelling portion 3 by the extension tool 10, the tip of the in-vivo indwelling portion 3 can be prevented from being damaged, and the in-dwelling indwelling portion 3 can be reduced in diameter. The operation of removing and inserting from the fistula can be performed safely and reliably.

補強部材５１は、ガイドワイヤ挿通孔４によるガイドワイヤの体外と臓器内の連絡に支障を与えなければ、その形状や材質等は特に限定されない。例えば金属又は熱硬化性樹脂等の材質で形成される。特に金属製のメッシュであることが好ましく、成形時にメッシュの格子内に樹脂が回りこむことで、金属製のメッシュと上記体内留置部３を構成する樹脂の接触面積を大幅に増すことができ、強度を向上させることができる。   The shape, material, etc. of the reinforcing member 51 are not particularly limited as long as the reinforcing member 51 does not hinder the connection between the guide wire outside the body and the organ through the guide wire insertion hole 4. For example, it is made of a material such as a metal or a thermosetting resin. In particular, it is preferably a metal mesh, and the resin wraps around the mesh lattice during molding, so that the contact area between the metal mesh and the resin constituting the in-vivo indwelling portion 3 can be greatly increased. Strength can be improved.

また、瘻孔用カテーテル１を形成する管状部材２と体内留置部３、体内留置部３に付設されるガイドワイヤ挿通孔４、当接部５に加え補強部材５１も、通常圧縮成形により一体成形で作製される。   In addition to the tubular member 2 that forms the fistula catheter 1, the indwelling portion 3, the guide wire insertion hole 4 attached to the indwelling portion 3, and the abutment portion 5, the reinforcing member 51 is also usually integrally formed by compression molding. Produced.

次に、第２の実施の形態における瘻孔用カテーテルを図４にて説明する。
第２の実施の形態における瘻孔用カテーテル６において、図１と同一構成要素には同一符号を付してその説明を省略し、異なる点について主に説明する。すなわち、第２の実施の形態における瘻孔用カテーテル６において、第１の実施の形態における瘻孔用カテーテル１と異なる点は、管状部材２の患者の体表部に位置する部分に体外固定部７を設けた点と、管状部材２の先端部に一方弁８を付設した点にある。 Next, a fistula catheter according to a second embodiment will be described with reference to FIG.
In the fistula catheter 6 according to the second embodiment, the same components as those in FIG. 1 are denoted by the same reference numerals, description thereof is omitted, and different points are mainly described. That is, the fistula catheter 6 according to the second embodiment is different from the fistula catheter 1 according to the first embodiment in that the extracorporeal fixing portion 7 is provided at a portion of the tubular member 2 located on the body surface of the patient. The point provided is that the one-way valve 8 is provided at the tip of the tubular member 2.

体外固定部７は、瘻孔用カテーテル６の埋設状態において、患者の体表に位置する部分に設けられ、瘻孔用カテーテル６が患者の体内（臓器内）へ埋没しないようにするものである。上記体外固定部７は上記管状部材２の後端に付設され、管状部材２の径方向外側に張り出した状態のものであればその形状は特に限定しない。例えば栄養通路の後端の開口周りに付設される扁平状物が挙げられる。上記体外固定部７は、瘻孔用カテーテル６のうち、唯一患者に見える部分であるため、扁平状物であれば、嵩張りが少なく、患者の生活に支障をきたさない点で好ましい。また、本例の体外固定部７には栄養通路の後端の開口に嵌合する栓７１が、連結部材７２を介して取付けられている。栓７１は瘻孔用カテーテル６の埋設状態において、栄養又は薬液を体外から胃内へ経皮的に補給しない時、栓７１を栄養通路の開口に嵌合させることで、胃内の気密を保つことができる。   The extracorporeal fixation unit 7 is provided in a portion located on the surface of the patient's body when the fistula catheter 6 is embedded, and prevents the fistula catheter 6 from being embedded in the patient's body (inside the organ). The shape of the extracorporeal fixing part 7 is not particularly limited as long as it is attached to the rear end of the tubular member 2 and protrudes outward in the radial direction of the tubular member 2. For example, the flat thing attached around the opening of the rear end of a nutrient channel is mentioned. Since the extracorporeal fixing part 7 is the only part of the fistula catheter 6 that can be seen by the patient, a flat object is preferable in that it is less bulky and does not hinder the patient's life. In addition, a plug 71 that fits into the opening at the rear end of the nutrient passage is attached to the extracorporeal fixing portion 7 of this example via a connecting member 72. When the plug 71 is embedded in the fistula catheter 6 and no nutrient or chemical solution is transdermally supplied from the outside of the body into the stomach, the plug 71 is fitted into the opening of the nutrition passage to keep the stomach tight. Can do.

また、本例の瘻孔用カテーテル６は、第１の実施形態の瘻孔用カテーテル１に比較し、管状部材２が患者の瘻孔の長さにフィットするように設計されている。したがって、管状部材２のうち患者の体外部に長く伸びる部分が無い為、胃内容物が患者の体外に流れてくる距離が短く、これを補う為、一般的に一方弁８が付設される。患者に対し栄養又は薬液を体外から胃内へ経皮的に補給することができると共に、胃内から液物が体外へ逆流することがない点で付設されることが好ましい。   In addition, the fistula catheter 6 of this example is designed so that the tubular member 2 fits the length of the patient's fistula as compared to the fistula catheter 1 of the first embodiment. Accordingly, since there is no portion of the tubular member 2 that extends long outside the patient's body, the distance that the stomach contents flow out of the patient's body is short. To compensate for this, a one-way valve 8 is generally provided. It is preferable that the patient can be supplemented with nutrients or a chemical solution from the outside of the body into the stomach and that the liquid does not flow backward from the inside of the stomach.

図５に本例の瘻孔用カテーテル６に伸展具１０をセットした際の断面図を示す。
一方弁８は、公知の弁が使用でき、その形状は特に限定しない。例として、ダックビル弁を示す。また、本例では一方弁８の付設位置が上記管状部材２の先端部である構成を図示しているが、瘻孔用カテーテル６の栄養通路内であれば、どの位置でも上記液物の逆流を防止することができ、付設位置についても特に限定しない。 FIG. 5 shows a cross-sectional view when the extension device 10 is set on the fistula catheter 6 of this example.
On the other hand, the valve 8 can use a well-known valve, and the shape is not specifically limited. As an example, a duckbill valve is shown. In addition, in this example, the configuration in which the one-way valve 8 is attached to the distal end of the tubular member 2 is illustrated, but the liquid can flow back at any position within the nutrient passage of the fistula catheter 6. The attachment position is not particularly limited.

瘻孔用カテーテル６も瘻孔用カテーテル１と同様に、体外固定部７を含み、通常圧縮成形により一体成形で作製される。   Similarly to the fistula catheter 1, the fistula catheter 6 includes an extracorporeal fixing part 7 and is usually produced by integral molding by compression molding.

以上、本発明の瘻孔用カテーテルを図示の実施形態の基づいて説明したが、本発明はこれに限定されるものではない。
例えば、管状部材と、体内留置部と、ガイドワイヤ挿通孔と、当接部と、体外固定部と、一方弁については同様の機能を有し得る任意の構成のものと置換することができる。 Although the fistula catheter of the present invention has been described based on the illustrated embodiment, the present invention is not limited to this.
For example, the tubular member, the indwelling portion, the guide wire insertion hole, the contact portion, the extracorporeal fixing portion, and the one-way valve can be replaced with any configuration that can have the same function.

本発明による瘻孔用カテーテルの第１の実施形態を示す斜視図である。1 is a perspective view showing a first embodiment of a fistula catheter according to the present invention. FIG. 本発明による瘻孔用カテーテルの伸展性を示す図である。It is a figure which shows the extensibility of the catheter for fistula by this invention. 本発明による第１の実施形態の瘻孔用カテーテルに伸展具をセットした際の断面図である。It is sectional drawing when an extender is set to the catheter for fistula of 1st Embodiment by this invention. 本発明による瘻孔用カテーテルの第２の実施形態を示す斜視図である。It is a perspective view which shows 2nd Embodiment of the catheter for fistula by this invention. 本発明による第２の実施形態の瘻孔用カテーテルに伸展具をセットした際の断面図である。It is sectional drawing when an extender is set to the catheter for fistula of 2nd Embodiment by this invention.

符号の説明Explanation of symbols

１ 瘻孔用カテーテル
２ 管状部材
２１ 管腔
３ 体内留置部
４ ガイドワイヤ挿通孔
５ 当接部
５１ 補強部材
６ 瘻孔用カテーテル
７ 体外固定部
７１ 栓
７２ 連結部材
８ 一方弁
１０ 伸展具
１１ ガイドワイヤ通路 DESCRIPTION OF SYMBOLS 1 Fistula catheter 2 Tubular member 21 Lumen 3 Indwelling part 4 Guide wire insertion hole 5 Contact part 51 Reinforcing member 6 Fistula catheter 7 External fixation part 71 Plug 72 Connecting member 8 One-way valve 10 Extender 11 Guide wire passage

Claims (9)

栄養剤又は薬剤等の液状物質を体外から体内臓器へ経皮的に補給する瘻孔用カテーテルであって、
前記液状物質を補給する管腔を有する管状部材と、
前記管状部材の先端部に付設され、体内臓器内にて前記瘻孔用カテーテルを留置固定する体内留置部とが一体的に成形されていると共に、
前記管状部材のジュロメーター硬度が前記体内留置部より高いことを特徴とする瘻孔用カテーテル。 A fistula catheter for percutaneously replenishing a liquid substance such as a nutrient or a drug from outside the body to a body organ,
A tubular member having a lumen for replenishing the liquid substance;
Attached to the distal end of the tubular member and integrally formed with an indwelling part for indwelling and fixing the fistula catheter in a body organ,
A fistula catheter, wherein the tubular member has a durometer hardness higher than that of the indwelling portion. 前記体内留置部のジュロメーター硬度は、Ａスケールで３０以上、６０以下である請求項１に記載の瘻孔用カテーテル。   The fistula catheter according to claim 1, wherein the durometer hardness of the indwelling part is 30 or more and 60 or less on the A scale. 前記管状部材のジュロメーター硬度は、Ａスケールで５０以上、７５以下である請求項１に記載の瘻孔用カテーテル。   The fistula catheter according to claim 1, wherein the tubular member has a durometer hardness of 50 or more and 75 or less on an A scale. 前記体内留置部は７５０％以上の切断時伸びを示す樹脂で構成されることを特徴とする請求項１または２に記載の瘻孔用カテーテル。   The fistula catheter according to claim 1 or 2, wherein the indwelling portion is made of a resin exhibiting an elongation at the time of cutting of 750% or more. 前記管状部材の基端側には、体外固定部が付設されている請求項１又は３に記載の瘻孔用カテーテル。   The fistula catheter according to claim 1 or 3, wherein an extracorporeal fixing part is attached to a proximal end side of the tubular member. 前記体内留置部の先端部には、体外と体内臓器間をガイドワイヤが挿通する為のガイドワイヤ挿通孔が付設されている請求項１、２、４のいずれかに記載の瘻孔用カテーテル。   The fistula catheter according to any one of claims 1, 2, and 4, wherein a distal end portion of the indwelling portion is provided with a guide wire insertion hole for allowing a guide wire to pass between the outside of the body and an internal organ. 前記体内留置部の先端部内面には、補強部材が付設されている請求項１、２、４、６のいずれかに記載の瘻孔用カテーテル。   The fistula catheter according to any one of claims 1, 2, 4, and 6, wherein a reinforcing member is attached to an inner surface of a distal end portion of the indwelling portion. 前記補強部材がメッシュ状の金属である請求項７に記載の瘻孔用カテーテル。   The fistula catheter according to claim 7, wherein the reinforcing member is a mesh metal. 更に前記管状部材の内腔には、前記液状物質が体内臓器から前記管状部材の内腔を経て体外へ逆流することを防ぐ一方弁が付設されている請求項１、３、５のいずれかに記載の瘻孔用カテーテル。   Further, the lumen of the tubular member is provided with a one-way valve for preventing the liquid substance from flowing back from the body organ through the lumen of the tubular member to the outside of the body. The fistula catheter as described.
JP2008072587A 2008-03-19 2008-03-19 Fistula catheter Pending JP2009225895A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013188413A (en) * 2012-03-15 2013-09-26 Sumitomo Bakelite Co Ltd Gastrostomy catheter
WO2015186626A1 (en) * 2014-06-03 2015-12-10 テルモ株式会社 Expansion device
JP2015226731A (en) * 2014-06-03 2015-12-17 テルモ株式会社 Expansion device

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004096115A1 (en) * 2003-04-28 2004-11-11 Sumitomo Bakelite Company Limited Catheter kit for burrow
JP2005312723A (en) * 2004-04-30 2005-11-10 Nippon Sherwood Medical Industries Ltd Gastrostomy tube extender
JP2006149576A (en) * 2004-11-26 2006-06-15 Hakko Co Ltd Medical connector

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004096115A1 (en) * 2003-04-28 2004-11-11 Sumitomo Bakelite Company Limited Catheter kit for burrow
JP2005312723A (en) * 2004-04-30 2005-11-10 Nippon Sherwood Medical Industries Ltd Gastrostomy tube extender
JP2006149576A (en) * 2004-11-26 2006-06-15 Hakko Co Ltd Medical connector

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013188413A (en) * 2012-03-15 2013-09-26 Sumitomo Bakelite Co Ltd Gastrostomy catheter
WO2015186626A1 (en) * 2014-06-03 2015-12-10 テルモ株式会社 Expansion device
JP2015226731A (en) * 2014-06-03 2015-12-17 テルモ株式会社 Expansion device

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