JP2010005282A - Medical drain tube - Google Patents
Medical drain tube Download PDFInfo
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- JP2010005282A JP2010005282A JP2008170730A JP2008170730A JP2010005282A JP 2010005282 A JP2010005282 A JP 2010005282A JP 2008170730 A JP2008170730 A JP 2008170730A JP 2008170730 A JP2008170730 A JP 2008170730A JP 2010005282 A JP2010005282 A JP 2010005282A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/84—Drainage tubes; Aspiration tips
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Abstract
Description
本発明は、医療用ドレーンチューブに関する。 The present invention relates to a medical drain tube.
ドレーンチューブは、外科用医療用具として体液の排出用に多用されており、様々な内外径、断面構造、形状を持った製品が市販されている。従来のドレーンチューブは、図２に示したように、体液の貯留部位に挿入した場合はドレーンチューブの先端部分から、あるいはドレーンチューブに側孔のある場合はドレーンチューブの先端及び、側孔部分から体液がドレーンチューブ内に流入し、排出される構造になっている。これらのドレーンチューブの使用に伴う問題点は、患者の創部が治癒する前に、体組織がドレーンチューブの側孔内へ向かって成長し、側孔が塞がれるだけでなく、ドレーンチューブ抜去時に体組織が引き裂かれる結果になり、患者に大きな痛みを与える点にある。 Drain tubes are widely used as surgical instruments for draining body fluids, and products having various inner and outer diameters, cross-sectional structures, and shapes are commercially available. As shown in FIG. 2, the conventional drain tube is inserted from the distal end portion of the drain tube when inserted into a body fluid storage site, or from the distal end and side hole portion of the drain tube when the drain tube has a side hole. Body fluid flows into the drain tube and is discharged. The problem with using these drain tubes is that not only does the tissue grow into the side holes of the drain tube before the wound is healed, the side holes are blocked, but also when the drain tube is removed. The result is that the body tissue is torn and it causes great pain to the patient.
これらの対策として、ドレーンチューブの外側に複数の溝を設け、その溝によって体液の排出を行うもの（例えば、特許文献１参照）が提案されている。これは、図３に示したように、留置時に体外に出る部分については円形のストレートチューブとし、体内に留置される部分については、上記のような溝を設けた構造になっている。従って、ドレーンチューブの長手方向の外面に溝が設けられている構造により、患者の傷の治癒後には痛みを伴うことなく抜去することができる。 As these measures, there has been proposed one in which a plurality of grooves are provided outside the drain tube and body fluid is discharged through the grooves (for example, see Patent Document 1). As shown in FIG. 3, the portion that goes out of the body at the time of indwelling is a circular straight tube, and the portion that is indwelled in the body is provided with a groove as described above. Therefore, the structure in which the groove is provided on the outer surface in the longitudinal direction of the drain tube allows the patient tube to be extracted without pain after healing of the patient's wound.
しかしながら、図２、３いずれのドレーンチューブも体内留置部からの排液の吸引量は、チューブ基端部から先端部にかけて一定ではなく、基端部から多く、先端部から十分な体液の吸引ができないことがあった。 However, in any of the drain tubes in FIGS. 2 and 3, the suction amount of the drainage from the indwelling portion is not constant from the tube proximal end portion to the distal end portion, and is large from the proximal end portion, and sufficient body fluid is sucked from the distal end portion. There was something I couldn't do.
本発明の目的は、体内留置部先端側からも十分な体液排出が可能であり、かつ治癒後のドレーンチューブ抜去時に患者に苦痛を与えることなく、容易に抜去できる医療用ドレーンチューブを提供することにある。 An object of the present invention is to provide a medical drain tube that can be sufficiently removed from the distal end side of the indwelling portion and can be easily removed without causing pain to the patient when the drain tube is removed after healing. It is in.
（１）後端部から先端部まで略同一の内外径を有する体外筒状部と、該体外筒状部の先端部に接着若しくは一体的に付設され複数の側孔を有する体内留置部と、で構成されたドレーンチューブであって、前記体内留置部は長軸方向に三等分してなる先端部、中央部、基端部を有し、前記体内留置部における側孔の総面積が先端部＞中央部＞基端部であることを特徴とする医療用ドレーンチューブ。
（２）前記体内留置部が先端に向かって縮径していることを特徴とする（１）に記載の医療用ドレーンチューブ。
（３）側孔が楕円形もしくは長円形をなしていることを特徴とする（１）または（２）に記載の医療用ドレーンチューブ。
(1) an extracorporeal cylindrical portion having substantially the same inner and outer diameter from the rear end portion to the distal end portion, an in-vivo indwelling portion having a plurality of side holes bonded or integrally attached to the distal end portion of the extracorporeal cylindrical portion; The indwelling portion has a distal end portion, a central portion, and a proximal end portion that are divided into three equal parts in the long axis direction, and the total area of the side holes in the indwelling portion is the distal end. Part> center part> base end part.
(2) The medical drain tube according to (1), wherein the indwelling portion is reduced in diameter toward the tip.
(3) The medical drain tube according to (1) or (2), wherein the side hole is elliptical or oval.
本発明によれば、体内留置部先端側からも十分な体液排出が可能であり、かつ治癒後のドレーンチューブ抜去時に患者に苦痛を与えることなく、容易に抜去できる医療用ドレーンチューブを提供できる。 According to the present invention, it is possible to provide a medical drain tube that can be sufficiently removed from the distal end side of the indwelling portion and can be easily removed without causing pain to the patient when the drain tube is removed after healing.
以下、本発明の実施の形態について、図面を用いて説明する。なお、すべての図面において、共通する構成要素には同一符号を付し、以下の説明において詳細な説明を適宜省略する。 Hereinafter, embodiments of the present invention will be described with reference to the drawings. In all the drawings, common constituent elements are denoted by the same reference numerals, and detailed description thereof will be appropriately omitted in the following description.
図１に示すとおり、本発明の医療用ドレーンチューブ（１）（以下、単に「ドレーンチューブ」ということがある）は、後端部から先端部まで略同一の内外径を有する体外筒状部（２）と、上記体外筒状部（２）の先端部に接着若しくは一体的に付設され複数の側孔（７）を有する体内留置部（３）とで構成されている。体内留置部（３）の接続部分の外径は、体外筒状部（２）のストレートチューブの外径に等しく、３ｍｍ以上、２０ｍｍ以下が好ましい。更に吸引性能、抜去抵抗の軽減などの実用性を考慮すると、５ｍｍ以上、１２ｍｍ以下が更に好ましい。内径は吸引性能に支障のないこと、チューブが肉薄になり、所望の留置位置にチューブが配置できるようにコシがなくならない程度であればよく、特に限定するものではないが、２ｍｍ以上、１９ｍｍ以下が好ましい。更に実用性を考慮すると、４ｍｍ以上、１１ｍｍ以下が更に好ましい。 As shown in FIG. 1, the medical drain tube (1) of the present invention (hereinafter sometimes simply referred to as “drain tube”) has an extracorporeal cylindrical portion having substantially the same inner and outer diameters from the rear end portion to the tip end portion ( 2) and an indwelling portion (3) having a plurality of side holes (7) attached or integrally attached to the distal end portion of the extracorporeal tubular portion (2). The outer diameter of the connecting portion of the in-vivo indwelling portion (3) is equal to the outer diameter of the straight tube of the extracorporeal tubular portion (2), and is preferably 3 mm or more and 20 mm or less. Further, in consideration of practicality such as reduction of suction performance and removal resistance, 5 mm or more and 12 mm or less are more preferable. The inner diameter is not particularly limited as long as there is no hindrance to the suction performance, the tube is thin, and the stiffness is not lost so that the tube can be placed at a desired indwelling position. Is preferred. Furthermore, when practicality is considered, 4 mm or more and 11 mm or less are still more preferable.
体内留置部（３）は体内に留置する先端方向に向かって縮径していることが好ましい。 体内留置部（３）の形状を上記のようにすることで、チューブ抜去時の抜去抵抗を軽減 することができる。 It is preferable that the indwelling part (3) has a reduced diameter in the direction of the distal end where it is placed in the body. By setting the shape of the indwelling portion (3) as described above, it is possible to reduce the removal resistance when the tube is removed.
本発明のドレーンチューブは、上記体内留置部（３）における側孔の総面積が先端部（４）＞中央部（５）＞基端部（６）であることを特徴とする。
ここで、図１（ａ）に示すように、側孔の大きさは全て同じとし、上記体内留置部（３）の３等分された部分の側孔（７）の数量を先端部（４）＞中央部（５）＞基端部（６）としてもいいし、図１（ｂ）に示すように、側孔（７）の数量は３等分された部分で同じとし、側孔（７）の大きさを先端部（４）＞中央部（５）＞基端部（６）としてもかまわない。又、上記２つの側孔の作成方法を併せたものでもかまわない。いずれにしても、体内留置部（３）における側孔（７）の総面積が先端部（４）＞中央部（５）＞基端部（６）の条件を満たしていれば良く、こうすることで従来のドレーンチューブと違って先端部に設けられた側孔からも十分なドレナージを行うことができる。
The drain tube of the present invention is characterized in that the total area of the side holes in the indwelling portion (3) is tip portion (4)> center portion (5)> base end portion (6).
Here, as shown in FIG. 1 (a), the sizes of the side holes are all the same, and the quantity of the side holes (7) divided into three equal parts of the indwelling part (3) is set to the tip (4 )> Center part (5)> base end part (6), and as shown in FIG. 1 (b), the number of side holes (7) is the same in the three parts, and the side holes ( The size of 7) may be set such that tip portion (4)> center portion (5)> base end portion (6). Moreover, it may be a combination of the above-mentioned two side hole forming methods. In any case, it is sufficient if the total area of the side holes (7) in the indwelling portion (3) satisfies the condition of the distal end portion (4)> the central portion (5)> the proximal end portion (6). Thus, unlike the conventional drain tube, sufficient drainage can be performed from the side hole provided at the tip.
側孔（７）の形状は円形、楕円形もしくは長円形であることが好ましい。その場合は、チューブ長手方向と長径が同一になるように設けることが好ましい。側孔（７）の直径は体内留置部（３）内に収まり、使用時に体内留置部（３）の引張強度に耐え得る強度を有し、排液を確実に吸引できる大きさであれば限定するものではないが、０．５ｍｍ以上、２ｍｍ以下が好ましい。側孔（７）の形状は、側孔（７）からの吸引量を確保するため、楕円形や長円形であっても良い。この側孔（７）は体内留置部（３）の内腔（８）に通じており、体内留置部（３）の内腔から体外筒状部（２）の内腔へ連通し、本発明のドレーンチューブ（１）全体を貫通している。本発明のドレーンチューブの長さは特に限定されないが、体内留置部（３）、体外筒状部（２）ともに１００ｍｍ以上、４００ｍｍ以下が好ましい。更に実用性を考慮すると、１００ｍｍ以上、２００ｍｍ以下が好ましい。 The shape of the side hole (7) is preferably circular, elliptical or oval. In that case, it is preferable to provide the tube so that the longitudinal direction is the same as the major axis. The diameter of the side hole (7) is limited as long as it fits in the indwelling part (3), has a strength that can withstand the tensile strength of the indwelling part (3) during use, and can suck the drainage reliably. Although it does not do, 0.5 mm or more and 2 mm or less are preferable. The shape of the side hole (7) may be oval or oval in order to secure the amount of suction from the side hole (7). The side hole (7) communicates with the lumen (8) of the indwelling portion (3) and communicates from the lumen of the indwelling portion (3) to the lumen of the external cylindrical portion (2). It penetrates the entire drain tube (1). Although the length of the drain tube of this invention is not specifically limited, 100 mm or more and 400 mm or less are preferable in both the indwelling part (3) and an external cylinder part (2). Furthermore, when practicality is considered, 100 mm or more and 200 mm or less are preferable.
本発明のドレーンチューブ（１）の材質は、軟質塩化ビニル樹脂やシリコーンゴムなど、医療用として一般に使用されているものでよく、特に限定されるものではない。ドレーンチューブの断面形状は円形のほか、チューブ強度を増すために、楕円形や長円形であっても良い。 The material of the drain tube (1) of the present invention is not particularly limited as long as it is generally used for medical purposes, such as soft vinyl chloride resin and silicone rubber. The cross-sectional shape of the drain tube may be circular or elliptical or oval to increase the tube strength.
体内留置部（３）と体外筒状部（２）を別々に形成して、接着、組立しても良いが、一体成形とする方が、内外面とも接着部における段差を無くすことができ、また、コスト的にも有利である。しかしながら、体内留置部（３）のテーパー形状について、シリコーンゴムは伸縮性に優れているため、テーパー形状の押出成形は困難となる。よって、テーパー形状とストレート形状を圧縮一体成形とするか、テーパー形状に圧縮成形したチューブと、ストレート押出成形してチューブを接着、組立してもよい。 The indwelling part (3) and the extracorporeal cylindrical part (2) may be separately formed and bonded and assembled, but the one-piece molding can eliminate the step in the bonded part on the inner and outer surfaces, Moreover, it is advantageous also in cost. However, with respect to the tapered shape of the indwelling portion (3), since silicone rubber is excellent in stretchability, it is difficult to extrude the tapered shape. Therefore, the taper shape and the straight shape may be compression-integrated, or the tube compression-molded into the taper shape and the straight extrusion may be used to bond and assemble the tube.
側孔（７）の加工方法としては、チューブの押出成形後に側孔数が少なければ、位置を確認し個々にポンチでくり抜いても良いが、側孔数が多い場合は、専用の側孔加工機で加工を施す方がコスト的に有利で工数削減となり好ましい。更に、ドレーンチューブ（１）には、使用目的に応じて、Ｘ線不透過材料による造影ラインを設けたり、体外留置部（２）の末端に吸引器などと接続するためのコネクターを設けること、あるいは体内穿刺用の尖刀針を取り外し可能に付設しても良い。 As for the processing method of the side holes (7), if the number of side holes is small after extrusion of the tube, the position may be confirmed and punched individually, but if the number of side holes is large, dedicated side hole processing Processing with a machine is preferable in terms of cost and man-hours. Furthermore, according to the purpose of use, the drain tube (1) is provided with a contrast line made of an X-ray-impermeable material, or a connector for connecting to an aspirator or the like at the end of the extracorporeal indwelling part (2). Alternatively, a pointed needle for puncture in the body may be detachably attached.
次に、本発明のドレーンチューブ（１）の使用方法について述べる。患者の体内に留置されたドレーンチューブ（１）は体外筒状部（２）の末端に接続された吸引器の吸引圧により、体内に貯留した体液などがチューブ先端と側孔（７）からチューブ内に吸引され、体外に排出される。本発明のドレーンチューブを用いれば、チューブ留置時は体内留置部（３）のチューブ先端までほぼ同等の吸引量で排液を吸引することが可能であり、チューブ抜去時はチューブがテーパー形状であることより、患者に苦痛を与えることなく、抜去を容易に行うことができる。 Next, a method for using the drain tube (1) of the present invention will be described. The drain tube (1) indwelled in the patient's body has a body fluid stored in the body through the tube tip and side hole (7) due to the suction pressure of the aspirator connected to the end of the extracorporeal cylindrical part (2). It is sucked in and discharged outside the body. When the drain tube of the present invention is used, it is possible to suck the drainage liquid with a substantially equal amount of suction up to the distal end of the tube of the indwelling portion (3) during tube placement, and the tube is tapered when the tube is removed. As a result, the extraction can be easily performed without causing pain to the patient.
次に、本発明の医療用ドレーンチューブと従来の側孔仕様のドレーンチューブとの下記項目における比較試験を実施した。結果を表１に示す。 Next, a comparative test was performed on the following items between the medical drain tube of the present invention and a conventional drain tube having a side hole specification. The results are shown in Table 1.
（実施例１〜７）
外径６．４ｍｍ、内径４．２ｍｍ、長さ４００ｍｍのドレーンチューブを用い、先端 部、中央部及び基端部における側孔面積の比が表１に示す数値になるように側孔を作成 した。１つの側孔の直径は１．２５ｍｍとした。
図４に示すように、先端部、中央部及び基端部の側孔部分が３つの各容器内に収まる ように配置し、３つの容器を貫くようにドレーンチューブを配置した。容器同士はチュ ーブで接続され、容器同士の間隔は１５０ｍｍとした。容器とチューブの隙間も接着剤 にて埋め、容器に水を入れた際に漏れのないようにした。ドレーンチューブに吸引機を 接続し、１５０ｃｍＨ２Ｏの圧力にて各容器に入れた１５０ｍＬの水を吸引した際に、 先端部、中央部及び基端部の３つの側孔部からの吸引量の違いを測定した。３つの各容 器の吸引量を相対比較するため、基端部の吸引量が５０ｍＬとなった時の他の容器の吸 引量を記録した。
(Examples 1-7)
Using a drain tube with an outer diameter of 6.4 mm, an inner diameter of 4.2 mm, and a length of 400 mm, side holes were created so that the ratio of the side hole area at the tip, center, and proximal end would be the values shown in Table 1. . The diameter of one side hole was 1.25 mm.
As shown in FIG. 4, the side hole portions at the distal end portion, the central portion, and the proximal end portion were disposed so as to be accommodated in the three containers, and the drain tube was disposed so as to penetrate the three containers. The containers were connected by a tube, and the distance between the containers was 150 mm. The gap between the container and the tube was filled with adhesive to prevent leakage when water was poured into the container. When a suction machine is connected to the drain tube and 150 mL of water in each container is aspirated at a pressure of 150 cmH2O, the difference in the amount of suction from the three side holes at the tip, center, and base end It was measured. In order to make a relative comparison of the suction volume of each of the three containers, the suction volume of the other container was recorded when the suction volume at the base end became 50 mL.
（比較例）
外径６．４ｍｍ、内径４．２ｍｍ、長さ４００ｍｍに切断した図２に示すような側孔 仕様（先端部、中央部及び基端部の側孔の形状大きさ同等）のドレーンチューブを用い 、先端部、中央部及び基端部における側孔面積の比が表１に示す数値（１：１：１）に なるように側孔を作成した。
１つの側孔の直径は１．２５ｍｍとした。３つの側孔部分が３つの各容器内に収まる ように配置した。３つの容器を貫くようにのドレーンチューブを配置した。容器同士は チューブで接続され、容器とチューブの隙間も接着剤にて埋め、容器に水を入れた際に 漏れのないようにした。ドレーンチューブに吸引機を接続し、１５０ｃｍＨ２Ｏの圧力 にて各容器に入れた１５０ｍＬの水を吸引した際に、先端部、中央部及び基端部の３つ の側孔部からの吸引量の違いを測定した。３つの各容器の吸引量を相対比較するため、 基端部の吸引量が５０ｍＬとなった時の他の容器の吸引量を記録した。
(Comparative example)
Use a drain tube with a side hole specification (equivalent to the shape and size of the side hole at the tip, center, and base end) as shown in FIG. 2 cut to an outer diameter of 6.4 mm, an inner diameter of 4.2 mm, and a length of 400 mm. The side holes were created so that the ratio of the side hole areas at the tip, center and base ends was the numerical value shown in Table 1 (1: 1: 1).
The diameter of one side hole was 1.25 mm. The three side hole portions were arranged so as to fit in the three containers. A drain tube was placed through the three containers. The containers were connected by a tube, and the gap between the container and the tube was filled with an adhesive to prevent leakage when water was poured into the container. When a suction machine is connected to the drain tube and 150 mL of water in each container is sucked at a pressure of 150 cmH2O, the difference in the amount of suction from the three side holes at the tip, center, and base end Was measured. In order to make a relative comparison of the suction amount of each of the three containers, the suction amount of the other container was recorded when the suction amount at the base end became 50 mL.
表１の結果から明らかなように、本発明のドレーンチューブを用いた実施例１〜７は、体内留置部の基端部の側孔からだけでなく、先端部、中央部の側孔からも十分な排液の排出が可能であり、先端部の側孔面積が基端部の側孔面積の１０倍となる実施例７においてほぼ均一に吸引できることを確認した。
一方、従来のドレーンチューブである比較例においては、均一な割合で側孔が設けられているため、体内留置部の先端部、中央部からの吸引量は基端部より吸引量が少なく、特に先端部からの吸引量は基端部の６０％程度であった。
上記模擬実験と実際の治療現場における使用例とは必ずしも同じ条件ではないが、治療現場では一度ドレーンチューブの先端側の側孔が詰まると従来の側孔を有するドレーンチューブでは吸引力が元々基端部側より弱いため、十分な排液ができず浸出液がそのまま残ることにより治癒が遅くなり、ひいては入院期間の延長をきたす場合がある。この点、本発明のドレーンチューブを用いれば先端側からも十分な排液が期待でき、入院期間の短縮が図れる可能性があるものといえる。
As is clear from the results in Table 1, Examples 1 to 7 using the drain tube of the present invention are not only from the side hole at the proximal end portion of the indwelling portion, but also from the side hole at the distal end portion and the central portion. It was confirmed that sufficient drainage was possible and that the side hole area of the tip end portion could be sucked almost uniformly in Example 7 where the side hole area of the base end portion was 10 times the side hole area.
On the other hand, in the comparative example which is a conventional drain tube, since the side holes are provided at a uniform rate, the suction amount from the distal end portion and the central portion of the indwelling portion is smaller than the proximal end portion, The amount of suction from the distal end was about 60% of the proximal end.
Although the above-mentioned simulation experiment and the actual use example in the treatment site are not necessarily the same conditions, once the side hole at the distal end side of the drain tube is once clogged at the treatment site, the suction force is originally the base end in the drain tube having the conventional side hole. Since it is weaker than the department side, sufficient drainage cannot be performed and the exudate remains as it is, and healing may be delayed, which may result in prolonged hospitalization. In this regard, if the drain tube of the present invention is used, it can be said that sufficient drainage can be expected from the distal end side and the hospitalization period may be shortened.
１ 医療用ドレーンチューブ
２ 体外筒状部
３ 体内留置部
４ 先端部
５ 中央部
６ 基端部
７ 側孔
８ 内腔
１１ 側孔付きドレーンチューブ
１２ 溝付きドレーンチューブ
１３ 溝
DESCRIPTION OF
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2008170730A JP2010005282A (en) | 2008-06-30 | 2008-06-30 | Medical drain tube |
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| Application Number | Priority Date | Filing Date | Title |
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| JP2008170730A JP2010005282A (en) | 2008-06-30 | 2008-06-30 | Medical drain tube |
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| JP2010005282A true JP2010005282A (en) | 2010-01-14 |
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| Application Number | Title | Priority Date | Filing Date |
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| JP2008170730A Pending JP2010005282A (en) | 2008-06-30 | 2008-06-30 | Medical drain tube |
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| CN107952124A (en) * | 2017-12-11 | 2018-04-24 | 浙江大学 | Wound surface flushing device |
| JP2020531157A (en) * | 2017-08-25 | 2020-11-05 | ストラタカ システムズ リミテッド | Ureter and bladder catheters and methods that induce negative pressure and increase renal perfusion |
| US11541205B2 (en) | 2015-07-20 | 2023-01-03 | Roivios Limited | Coated urinary catheter or ureteral stent and method |
| US11612714B2 (en) | 2015-07-20 | 2023-03-28 | Roivios Limited | Systems and methods for inducing negative pressure in a portion of a urinary tract of a patient |
| US11752300B2 (en) | 2015-07-20 | 2023-09-12 | Roivios Limited | Catheter device and method for inducing negative pressure in a patient's bladder |
| US11896785B2 (en) | 2015-07-20 | 2024-02-13 | Roivios Limited | Ureteral and bladder catheters and methods of inducing negative pressure to increase renal perfusion |
| US11904121B2 (en) | 2015-07-20 | 2024-02-20 | Roivios Limited | Negative pressure therapy system |
| US11918754B2 (en) | 2015-07-20 | 2024-03-05 | Roivios Limited | Ureteral and bladder catheters and methods of inducing negative pressure to increase renal perfusion |
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| JP2021180954A (en) * | 2017-08-25 | 2021-11-25 | ストラタカ システムズ リミテッド | Ureteral and bladder catheters and methods for inducing negative pressure to increase renal perfusion |
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