JP7054570B1

JP7054570B1 - Painless catheter for organs communicated with an opening on the body surface

Info

Publication number: JP7054570B1
Application number: JP2021186158A
Authority: JP
Inventors: 義弘岸上
Original assignee: 義弘岸上
Priority date: 2021-11-16
Filing date: 2021-11-16
Publication date: 2022-04-14
Anticipated expiration: 2041-11-16
Also published as: JP2023073605A

Abstract

【課題】カテーテルを開口部から体内に挿入するとき、及び体内ら抜去するときの、カテーテル先端が開口部と連通された臓器の開口部を押し広げるために加える力、及びカテーテルと臓器内面の粘膜との摩擦を軽減し、カテーテルを挿入するとき、及び抜去するときの患者の苦痛を軽減することを目的とする。【解決手段】開口部と連通された臓器の開口部から内部に遠位端部が挿入されるカテーテル管と、二重円筒形であって、カテーテル管を一枚で包み、カテーテル管の長軸方向に沿って回転可能に設けられた端部のない薄膜と、を有し、薄膜の内面とカテーテル管との静摩擦抵抗が、臓器内面の粘膜と薄膜の外面との静摩擦抵抗より小さいことを特徴とする開口部と連通された臓器用無痛カテーテルを提供する。【選択図】図１PROBLEM TO BE SOLVED: To apply a force applied by a catheter tip to expand an opening of an organ communicated with an opening when inserting the catheter into the body through the opening and when removing the catheter from the body, and a mucous membrane of the catheter and the inner surface of the organ. The purpose is to reduce the friction with the catheter and to reduce the patient's pain when inserting and removing the catheter. SOLUTION: A catheter tube in which a distal end is inserted inside from an opening of an organ communicated with the opening, and a double cylindrical shape in which the catheter tube is wrapped in one piece and a long axis of the catheter tube. It has an endless thin film that is rotatably provided along the direction, and is characterized in that the static friction resistance between the inner surface of the thin film and the catheter tube is smaller than the static friction resistance between the mucous membrane on the inner surface of the organ and the outer surface of the thin film. Provided is a painless catheter for an organ communicated with the opening. [Selection diagram] Fig. 1

Description

本発明は、体表の開口部と連通された臓器（以下単に「臓器」と記すことがある）の体表の開口部から体内に挿入される無痛カテーテルに係り、より詳しくは、カテーテルの挿入時にカテーテルの先端が臓器の体表の開口部及び内面を押し広げるために加える力を軽減する、体表の開口部と連通された臓器用無痛カテーテルに関する。 The present invention relates to a painless catheter inserted into the body through an opening on the body surface of an organ communicated with an opening on the body surface (hereinafter, may be simply referred to as "organ"), and more particularly, insertion of the catheter. It relates to a painless catheter for an organ communicated with an opening of the body surface, sometimes reducing the force exerted by the tip of the catheter to expand the opening and inner surface of the body surface of the organ.

カテーテル（ｋａｔｈｅｔｅｒ：オランダ）は、体内に挿入される管状の医療器具である。当初は検査用として用いられたが、近年は、代用血管、排尿、電極、インプラントの挿入等のような生体材料品の身体内、及び身体上への適用を、外科手術をしなくても、カテーテルを用いる治療によって容易に行うことが可能になった。カテーテル治療は、患者の負担を軽減することができる小侵襲治療として発展中の医学分野の一つである。
また、体表の開口部と連通された臓器としては、例えば消化器、呼吸器、腎臓、女性性器等が挙げられるが、これらに限られるものではない。カテーテル治療の発展に伴って更に多くの臓器や器官に応用することが可能であると考えらえる。更に、挿入するカテーテルの先端の位置は、体表の開口部と臓器との中間部、臓器の入り口、及び臓器の内部のいずれであってもよい。 A catheter (the Netherlands) is a tubular medical device that is inserted into the body. Initially used for testing, in recent years biomaterials such as substitute blood vessels, urination, electrodes, implant insertion, etc. can be applied intrabody and onto the body without surgery. Treatment with a catheter has made it easier to do. Catheter treatment is one of the developing medical fields as a small invasive treatment that can reduce the burden on patients.
The organs communicated with the opening on the body surface include, but are not limited to, digestive organs, respiratory organs, kidneys, female genital organs, and the like. With the development of catheter treatment, it can be applied to more organs and organs. Further, the position of the tip of the catheter to be inserted may be any of the intermediate portion between the opening of the body surface and the organ, the entrance of the organ, and the inside of the organ.

ところで、カテーテルを患者の体内に挿入する場合は、全身麻酔して行われることが多い。しかし、全身麻酔をかけることは、患者に一時的に意識乃至感覚を失うという恐怖感を与え、また部分麻酔であっても、麻酔から完全に覚醒するまでには長時間を要するために、簡単な検査だけでも入院が必要とされることも多く、麻酔は、患者に多大な負担を強いるものである。このため、例えば胃、大腸、肺、膀胱、女性器などの、体表に開口部を有する臓器にカテーテルを挿入する場合は、できる限り麻酔をかけずにカテーテルを挿入することが望まれている。 By the way, when a catheter is inserted into a patient's body, it is often performed under general anesthesia. However, general anesthesia is easy because it gives the patient a fear of temporary loss of consciousness or sensation, and even partial anesthesia takes a long time to fully awaken from anesthesia. In many cases, hospitalization is required even for a simple examination, and anesthesia imposes a heavy burden on the patient. Therefore, when inserting a catheter into an organ having an opening on the body surface , such as the stomach, large intestine, lungs, bladder, and female genitalia, it is desired to insert the catheter without anesthesia as much as possible. ..

本発明は、体表の開口部と連通された臓器に挿入するカテーテルに関する。ここで、カテーテルが挿入される臓器の、体表の開口部は、神経が鋭敏な部位が多く、またカテーテルの直径は臓器の、体表の開口部の直径より大きい場合が多いので、麻酔をかけずにカテーテルを挿入する場合は、カテーテルの先端が体表臓器の、体表の開口部を押し広げるために加えられる力、及びカテーテルと臓器内面の粘膜との摩擦によって、たとえ局所麻酔をかけたとしても、患者に大きな苦痛を与えることが多い。
また、臓器の内部に長時間留置されたカテーテルは、カテーテル管の外面と臓器内面の粘膜とが癒着することがあり、抜去時に癒着を剥がす際に、患者に大きな苦痛を与えることがある。 The present invention relates to a catheter inserted into an organ communicated with an opening on the body surface. Here, the opening of the body surface of the organ into which the catheter is inserted is often a site where nerves are sensitive, and the diameter of the catheter is often larger than the diameter of the opening of the body surface of the organ, so anesthesia should be performed. When inserting the catheter without applying it, local anesthesia is applied even by the force applied by the tip of the catheter to expand the opening of the body surface of the body surface organ and the friction between the catheter and the mucous membrane on the inner surface of the organ. Even so, it often causes great pain to the patient.
In addition, a catheter that has been indwelled inside an organ for a long time may cause adhesion between the outer surface of the catheter tube and the mucous membrane on the inner surface of the organ, which may cause great pain to the patient when the adhesion is removed at the time of removal.

ここで、体表の開口部と連通された臓器内面の、粘膜との摩擦抵抗を軽減するカテーテル管の挿入方法として、図７（Ａ）に示すように、固定されていない筒状の薄膜３をカテーテル管２の近位端部１３の内側から供給し、先端の遠位端部１４で外側に反転させて図７（Ｂ）に示すように臓器の粘膜の内面とカテーテル管との間に薄膜３を挿入する方法がある。しかしこの方法は、図７（Ａ）に示すように、カテーテル管２の２倍の長さの薄膜３が必要になって未挿入の薄膜３が操作の妨げになるか、又は薄膜３を固定するためには２倍の長さのカテーテル管２が必要になって（図示しない）薄膜３又はカテーテル管２を支持するために手術の際は更に助手が必要となり、更に、カテーテル管２の交換は患者一人で行うことができず介護者が必要となるなどという問題があった。更にまた、この方法は、カテーテル管２の内部で薄膜３がしわになって、摩擦抵抗があまり減らないなどのために、実用的ではなかった。 Here, as a method of inserting a catheter tube for reducing the frictional resistance with the mucous membrane on the inner surface of the organ communicated with the opening on the body surface , as shown in FIG. 7A, an unfixed tubular thin film 3 Is supplied from the inside of the proximal end 13 of the catheter tube 2, inverted outward at the distal end 14 of the tip, and between the inner surface of the mucosa of the organ and the catheter tube as shown in FIG. 7 (B). There is a method of inserting the thin film 3. However, as shown in FIG. 7A, this method requires a thin film 3 that is twice as long as the catheter tube 2, and the uninserted thin film 3 interferes with the operation, or the thin film 3 is fixed. In order to do so, a catheter tube 2 of twice the length is required, and an additional assistant is required during surgery to support the thin film 3 or the catheter tube 2 (not shown), and the catheter tube 2 is replaced. There was a problem that the patient could not do it alone and a caregiver was needed. Furthermore, this method is not practical because the thin film 3 is wrinkled inside the catheter tube 2 and the frictional resistance is not significantly reduced.

また、カテーテル管を挿入する力を軽減する方法として、スライド管及び筒状のバルーン膜に囲まれて液体が挿入された定容積のルーメン（内腔）がカテーテル管内に挿入されたスライデイングカテーテルが公知である（例えば特許文献１を参照）。しかしこのスライデイングカテーテルは、カテーテル管とスライド管との二重管であり、体外から臓器内部への通路空間は内側のスライド管の内部に形成されるために、カテーテル全体の管径が更に太くなるという問題があり、カテーテルを挿入する場合の苦痛の軽減効果が十分ではなかった。
このために、体表に開口部を有する臓器へカテーテルを容易に挿入することができ、カテーテル挿入時の患者の苦痛が軽減されたカテーテルの開発が望まれていた。 In addition, as a method of reducing the force for inserting a catheter tube, a sliding catheter in which a fixed volume lumen (lumen) surrounded by a slide tube and a tubular balloon membrane and a liquid is inserted is inserted into the catheter tube is used. It is known (see, for example, Patent Document 1). However, this sliding catheter is a double tube consisting of a catheter tube and a slide tube, and the passage space from outside the body to the inside of the organ is formed inside the slide tube inside, so the diameter of the entire catheter is even larger. There was a problem that the catheter was not sufficiently effective in reducing the pain when inserting the catheter.
For this reason, it has been desired to develop a catheter in which a catheter can be easily inserted into an organ having an opening on the body surface and the patient's pain at the time of inserting the catheter is reduced.

特開平８－１９６６４０号公報Japanese Unexamined Patent Publication No. 8-196640

静止摩擦係数が生じる要因ｈｔｔｐｓ：／／ｗｗｗ．ｊｓｔ．ｇｏ．ｊｐ／ｃｐｓｅ／ｊｉｓｓｅｎ／ｐｄｆ／ｈｏｕｋｏｋｕ／ＳＧ１５０１２１＿００７．ｐｄｆ２０２１年７月１５日検索Factors that cause the coefficient of static friction https: // www. jst. go. jp / cpse / jissen / pdf / houkoku / SG150121_007. pdf Search on July 15, 2021 机でできる！静止摩擦係数の測定方法ｈｔｔｐｓ：／／ｒｉｖｉ－ｍａｎｕｆａｃｔｕｒｉｎｇ．ｃｏｍ／机でできる！％Ｅ３％８０％８０最大静止摩擦係数の測定方法２０２１年７月１５日検索You can do it at your desk! Method for measuring the coefficient of static friction https: // rivi-manufacturing. com / You can do it at your desk! % E3% 80% 80 Measurement method of maximum static friction coefficient July 15, 2021 Search

本発明は、体表の開口部と連通された臓器の内部にカテーテルを挿入する場合に、カテーテルの先端が臓器の、体表の開口部を押し広げるために加える力、及びカテーテルの挿入時に、カテーテルと臓器内面の粘膜との摩擦によって生じる患者の苦痛を軽減することができるカテーテルを提供することを目的とする。 INDUSTRIAL APPLICABILITY When inserting a catheter into an organ communicated with an opening on the body surface , the present invention applies a force applied by the tip of the catheter to expand the opening on the body surface of the organ, and when the catheter is inserted. It is an object of the present invention to provide a catheter capable of reducing the patient's pain caused by the friction between the catheter and the mucous membrane on the inner surface of the organ.

かかる課題を解決するための本発明の、体表の開口部と連通された臓器用無痛カテーテルは、体表の開口部と連通された臓器の、体表の開口部から臓器の内部に挿入されるカテーテル管と、カテーテル管の外周面を覆っている円筒形の一端をカテーテル管の近位端部で外周面側から内周面側に反転させて内周面側に繰り込み、内周面側を通して遠位端部に供給し、遠位端部で外側に反転させ、外周面に導出し、導出された一端を外周面を覆っている他端と連結させた端部のない二重円筒形であって、前記カテーテル管の長軸方向に沿って回転可能に設けられた薄膜と、を有し、薄膜の内面とカテーテル管との間の静摩擦抵抗が、薄膜の外面と臓器内面の粘膜との間の静摩擦抵抗より小さいことを特徴とする。 The painless catheter for an organ communicated with the opening of the body surface of the present invention for solving such a problem is inserted into the inside of the organ through the opening of the body surface of the organ communicated with the opening of the body surface. The catheter tube and one end of the cylindrical shape covering the outer peripheral surface of the catheter tube are inverted from the outer peripheral surface side to the inner peripheral surface side at the proximal end of the catheter tube and fed into the inner peripheral surface side. A double cylindrical shape with no end, which is supplied to the distal end through, inverted outward at the distal end, led to the outer peripheral surface, and the derived end is connected to the other end covering the outer peripheral surface. The thin film is rotatably provided along the longitudinal direction of the catheter tube, and the static frictional resistance between the inner surface of the thin film and the catheter tube is the mucous membrane of the outer surface of the thin film and the inner surface of the organ. It is characterized by being smaller than the static friction resistance between.

また、前記薄膜が、柔軟性及び伸縮性を有し、軽く引き延ばされた状態でカテーテル管を包んでいることが好ましい。
また、前記薄膜の内面とカテーテル管との間の静摩擦係数が０．４以下であることを特徴とする。
また、前記薄膜は、合成高分子樹脂製の薄膜であることが好ましい。 Further, it is preferable that the thin film has flexibility and elasticity and encloses the catheter tube in a lightly stretched state.
Further, the static friction coefficient between the inner surface of the thin film and the catheter tube is 0.4 or less.
Further, the thin film is preferably a thin film made of a synthetic polymer resin.

また、前記薄膜は、合成高分子樹脂繊維、又は天然高分子の繊維で紡織された布製の薄膜であることができる。
また、前記薄膜は、厚さが０．５ｍｍ以下であることを特徴とする。
また、前記薄膜は、外面と臓器内面の粘膜との間に相互の滑り移動を阻止するストッパーを更に備えることができる。 Further, the thin film can be a thin film made of cloth woven from synthetic polymer resin fibers or natural polymer fibers.
Further, the thin film is characterized in that the thickness is 0.5 mm or less.
In addition, the thin film may further be provided with a stopper that prevents mutual sliding movement between the outer surface and the mucous membrane on the inner surface of the organ.

また、本発明の体表の開口部と連通された臓器用無痛カテーテルの挿入方法は、請求項１～６のいずれか１項に記載の体表の開口部と連通された臓器用無痛カテーテルを、患者の臓器の、体表の開口部から臓器の、内部に挿入する方法であって、カテーテル管の遠位端部を開口部に押し当てて挿入方向に押圧することにより、カテーテル管が臓器に小さな押圧力で挿入されると共に、薄膜がカテーテル管の外周面と臓器内面の粘膜との間に挿入されて摩擦抵抗を軽減することにより患者の苦痛を軽減することを特徴とする。 Further, the method of inserting the painless organ for organs communicated with the opening of the body surface of the present invention is the painless catheter for organs communicated with the opening of the body surface according to any one of claims 1 to 6 . , A method of inserting the patient's organ from the opening of the body surface into the inside of the organ. By pressing the distal end of the catheter tube against the opening and pressing it in the insertion direction, the catheter tube becomes the organ. It is characterized in that the thin film is inserted between the outer peripheral surface of the catheter tube and the mucous membrane on the inner surface of the organ to reduce the frictional resistance, thereby reducing the patient's pain.

また、本発明の体表の開口部と連通された臓器用無痛カテーテルの抜去方法は、請求項１～６のいずれか１項に記載の体表の開口部と連通された臓器用無痛カテーテルを、患者の臓器の内部から抜去する方法であって、臓器の内部に挿入されたカテーテル管の内周面に接触する薄膜を、カテーテル管の抜去方向と平行な移動方向に引っ張って移動させながらカテーテル管を抜去することを特徴とする。 Further, as a method for removing the painless catheter for organs communicated with the opening of the body surface of the present invention, the painless catheter for organs communicated with the opening of the body surface according to any one of claims 1 to 6 is used. , A method of removing from the inside of a patient's organ, in which a thin film in contact with the inner peripheral surface of a catheter tube inserted inside the organ is pulled and moved in a movement direction parallel to the removal direction of the catheter tube. It is characterized by removing the tube.

本発明の、体表の開口部と連通された臓器用無痛カテーテルは、カテーテル管の遠位端部を、体表の開口部に押し当てて挿入方向に押圧することにより、遠位端部において、薄膜がカテーテル管の内周面から外周面に反転され、臓器内面の粘膜を押し広げながら外周面に繰り出されるのに伴って、臓器内面の粘膜が摩擦により外周面側に移動され体表の開口部が拡大されてカテーテルを挿入する力が軽減されると共に、薄膜がカテーテル管の外周面と臓器内面の粘膜との間に挿入されて摩擦抵抗をなくすことによって、患者の苦痛を軽減するという優れた効果を有する。
また本発明は、体表の開口部と連通された臓器内面の粘膜に接触する薄膜を、抜去する方向に移動させると、薄膜を抜去する力が薄膜を引き剥がす方向に転向され、例え薄膜が臓器の内表面と癒着していても、癒着を摩擦なくゆっくりと引き剥がしながら抜去することができ、カテーテル管を抜去する際の苦痛を軽減できるという優れた効果を有する。 The painless catheter for organs communicated with the opening of the body surface of the present invention is formed at the distal end by pressing the distal end of the catheter tube against the opening of the body surface and pressing it in the insertion direction. As the thin film is inverted from the inner peripheral surface of the catheter tube to the outer peripheral surface and is drawn out to the outer peripheral surface while expanding the mucous membrane on the inner surface of the organ, the mucous membrane on the inner surface of the organ is moved to the outer peripheral surface side by friction and the body surface. The opening is enlarged to reduce the force to insert the catheter, and a thin film is inserted between the outer peripheral surface of the catheter tube and the mucous membrane on the inner surface of the organ to eliminate frictional resistance, thereby reducing the patient's pain. Has an excellent effect.
Further, in the present invention, when the thin film in contact with the mucous membrane on the inner surface of the organ communicated with the opening on the body surface is moved in the direction of removal, the force for removing the thin film is converted in the direction of peeling the thin film, for example, the thin film is formed. Even if it adheres to the inner surface of the organ, it can be removed while slowly peeling it off without friction, and it has an excellent effect of reducing the pain when removing the catheter tube.

また本発明は、カテーテル管の外周面を覆っている円筒形の薄膜の一端を、カテーテル管の近位端部で外周面側から内周面側に反転させて内周面に繰り込み、内周面側を通して遠位端部に供給し、遠位端部で反転させ外周面に繰り出し、繰り出された薄膜の一端を、外周面を覆っている薄膜の他端と連結させて端部がない二重円筒形にして、カテーテル管の軸方向に回転自在にカテーテル管を包むことによって、カテーテル管の２倍の長さを有し浮動して邪魔になっていた薄膜（図７を参照）を、カテーテル管を包み、全体を僅かに伸張させて配置することによって、作業性が向上すると共に、薄膜とカテーテル管との間のしわが取り除かれ、またカテーテル管の遠位端部から薄膜が滑らかに繰り出されて、カテーテル管と薄膜との間の摩擦抵抗が減るという優れた効果を有する。 Further, in the present invention, one end of the cylindrical thin film covering the outer peripheral surface of the catheter tube is inverted from the outer peripheral surface side to the inner peripheral surface side at the proximal end of the catheter tube and carried into the inner peripheral surface. It is supplied to the distal end through the surface side, inverted at the distal end and fed out to the outer peripheral surface, and one end of the drawn thin film is connected to the other end of the thin film covering the outer peripheral surface and has no end. By forming a heavy cylinder and wrapping the catheter tube so that it can rotate in the axial direction of the catheter tube, the thin film (see FIG. 7), which has twice the length of the catheter tube and floats and is an obstacle, is formed. By wrapping the catheter tube and placing it in a slightly stretched position, workability is improved, wrinkles between the thin film and the catheter tube are removed, and the thin film is smoothed from the distal end of the catheter tube. It has the excellent effect of being unwound to reduce the frictional resistance between the catheter tube and the thin film.

更に本発明のカテーテルは、挿入する際、及び抜去する際の苦痛を軽減することができるので、カテーテル挿入時及び抜去時に麻酔する必要がなくなり、あるいは医師や看護婦の介護なしに患者自身でカテーテルの挿入、交換ができるケースが増えるなど、医療提供者及び患者の負担を軽減する効果がある。
また本発明のカテーテルはカテーテル管を容易に挿入できるので、カテーテル管のルーメン（内腔）を通じて内視鏡や手術用具などの用具を挿入し、それらを用いて検査、治療等を行うことができる。
とりわけ、気管支にカテーテルを挿通して内視鏡検査を行う場合に、気管支が敏感であって、たとえ麻酔中であっても患者が咳をすることがあり、これによって内視鏡を破損したり、患者に損傷を与えたりすることがあるが、本発明のカテーテルは、咳を誘発しにくいので、これを防ぐことができるという特徴を有する。
また、麻酔時に気管を確保するために気管に挿入するカテーテル（気管チューブ）は、挿入時に気管粘膜を傷つけ、麻酔覚醒後に咳が長く続き味覚に異常を生じるという問題があった。しかし、本発明のカテーテルは、挿入する際に気管粘膜を傷つけないので、咳も味覚異常も残らないという特徴を有する。 Further, the catheter of the present invention can reduce the pain when inserting and removing the catheter, so that it is not necessary to anesthetize when inserting and removing the catheter, or the patient himself / herself does not need the care of a doctor or a nurse. It has the effect of reducing the burden on medical providers and patients, such as increasing the number of cases in which catheters can be inserted and replaced.
Further, since the catheter of the present invention can easily insert a catheter tube, tools such as an endoscope and a surgical tool can be inserted through the lumen (lumen) of the catheter tube, and examination, treatment, etc. can be performed using them. ..
Especially when a catheter is inserted into the bronchus for endoscopy, the bronchus is sensitive and the patient may cough even during anesthesia, which may damage the endoscope. However, the catheter of the present invention is characterized in that it is difficult to induce cough, and thus it can be prevented.
Further, a catheter (tracheal tube) inserted into the trachea to secure the trachea at the time of anesthesia has a problem that the tracheal mucosa is damaged at the time of insertion, the cough continues for a long time after awakening of anesthesia, and the taste becomes abnormal. However, since the catheter of the present invention does not damage the tracheal mucosa when inserted, it has a feature that neither cough nor taste abnormality remains.

本発明の１実施例に係るカテーテルの模式断面図である。It is a schematic cross-sectional view of the catheter which concerns on one Example of this invention. 図１の遠位端部（点線で囲んだ楕円内）の部分拡大模式図である。It is a partially enlarged schematic diagram of the distal end portion (inside an ellipse surrounded by a dotted line) of FIG. 図１をＡ方向から見た部分内面図である。FIG. 1 is a partial internal view of FIG. 1 as viewed from the A direction. 本発明のカテーテルの抜去方法を説明する図である。It is a figure explaining the method of removing a catheter of this invention. 本発明の静摩擦抵抗係数の測定方法を説明する図である。It is a figure explaining the measuring method of the static friction resistance coefficient of this invention. Ａ～Ｃは、本発明の１実施形態に係る、カテーテルを体表の開口部と連通された臓器へ挿入する方法を説明する図である。FIGS. A to C are diagrams illustrating a method of inserting a catheter into an organ communicated with an opening of a body surface according to an embodiment of the present invention. 先行技術を示す図面であって、（Ａ）は、カテーテル管の遠位端部を体表の開口部と連通された臓器の、体表の開口部に押し当てた状態の図であり、（Ｂ）は、カテーテルが臓器に挿入された状態を示す図である。In the drawing showing the prior art, (A) is a view of the state where the distal end of the catheter tube is pressed against the opening of the body surface of the organ communicated with the opening of the body surface. B) is a diagram showing a state in which a catheter is inserted into an organ.

以下に添付図面を参照しつつ本発明を詳細に説明する。
図１は、本発明の１実施例に係るカテーテルの模式断面図である。
図１に示すように、本発明のカテーテル１は、両端が解放された円筒状のカテーテル管２と、カテーテル管２の内周面１２及び外周面１１を１枚で包んだ端部のない二重円筒形の薄膜３と、からなり、患者の体表５の開口部６から体内７の開口部と連通された臓器４に挿入される。符号２１は、体表の開口部と連通された臓器４の内面の粘膜である。 The present invention will be described in detail below with reference to the accompanying drawings.
FIG. 1 is a schematic cross-sectional view of a catheter according to an embodiment of the present invention.
As shown in FIG. 1, the catheter 1 of the present invention has a cylindrical catheter tube 2 having both ends open, and an endless two that wraps the inner peripheral surface 12 and the outer peripheral surface 11 of the catheter tube 2 with one sheet. It is composed of a heavy cylindrical thin film 3 and is inserted into an organ 4 which is communicated from an opening 6 of a patient's body surface 5 to an opening of a body 7. Reference numeral 21 is the mucous membrane on the inner surface of the organ 4 that communicates with the opening on the body surface .

［カテーテル管］
カテーテル管２は、通常に使用し得るカテーテル管であれば特に制限されない。両端が解放され、滑らかな近位端部１３と遠位端部１４とを有し、体表５の開口部６から体内７の開口部と連通された臓器４に挿入され得る。
また、カテーテル管２の寸法は、挿入する臓器及び使用目的に対応して決定することができる。更に、カテーテル管２の先端部の口径は、中間部の口径と同等か、又は小さいことが好ましい。 [Catheter tube]
The catheter tube 2 is not particularly limited as long as it is a catheter tube that can be normally used. Both ends are open and have a smooth proximal end 13 and a distal end 14, and can be inserted into an organ 4 communicating from the opening 6 of the body surface 5 to the opening of the body 7.
In addition, the dimensions of the catheter tube 2 can be determined according to the organ to be inserted and the purpose of use. Further, it is preferable that the diameter of the tip portion of the catheter tube 2 is equal to or smaller than the diameter of the intermediate portion.

また、カテーテル管２は、軽量であって適当な剛性及び柔軟性を兼備することが好ましく、材料は合成高分子樹脂を使用し得る。
ここで、合成高分子樹脂としては、通常にカテーテル管に使用され得るものであれば特に制限されず、具体的には、ポリエチレン、超高分子量ポリエチレン、ポリプロピレン、ポリスチレン、ポリ塩化ビニル、ポリ酢酸ビニル、ポリアクリロニトリル、ポリアセタール、ポリエチレンテレフタレート、ポリカーボネート、ポリエステル樹脂、ポリメタクリル樹脂、ポリアミド樹脂、ポリイミド樹脂、フッ素樹脂、フェノール樹脂、尿素樹脂、メラミン樹脂、ポリウレタン樹脂、シリコーン樹脂、アルキッド樹脂、エポキシ樹脂などを挙げ得るが、これらに限定されるものではない。なお、上記ポリマーは、単独で使用されても、２種以上の共重合体、混合物、複合体等の形態で使用されてもよい。 Further, the catheter tube 2 is preferably lightweight and has appropriate rigidity and flexibility, and a synthetic polymer resin can be used as the material.
Here, the synthetic polymer resin is not particularly limited as long as it can be normally used for a catheter tube, and specifically, polyethylene, ultrahigh molecular weight polyethylene, polypropylene, polystyrene, polyvinyl chloride, and polyvinyl acetate. , Polyacrylonitrile, polyacetal, polyethylene terephthalate, polycarbonate, polyester resin, polymethacrylic resin, polyamide resin, polyimide resin, fluororesin, phenol resin, urea resin, melamine resin, polyurethane resin, silicone resin, alkyd resin, epoxy resin, etc. Obtain, but are not limited to these. The polymer may be used alone or in the form of two or more copolymers, mixtures, complexes and the like.

［薄膜］
次に、薄膜３は、端部のない二重円筒形であって、柔軟性及び伸縮性を有し、カテーテル管２の外周面１１と内周面１２とを１枚で包んでカテーテル管２の軸に沿って回転自在になっていることが好ましい。
すなわち、薄膜３は、近位端部１３で外周面１１から内周面１２に反転して繰り込まれ、遠位端部１４で内周面１２から外周面１１に反転して繰り出されてカテーテル管２の長軸方向に沿って回転可能に設けられ、薄膜３の内面とカテーテル管２との静摩擦抵抗が、薄膜３の外面と臓器内面の粘膜２１との静摩擦抵抗より小さいことを特徴とする。
更に、薄膜３は、しわがないように軽く引き延ばされた状態でカテーテル管２を包んでいることが好ましい。 [Thin film]
Next, the thin film 3 has a double cylindrical shape without an end, has flexibility and elasticity, and wraps the outer peripheral surface 11 and the inner peripheral surface 12 of the catheter tube 2 with one sheet. It is preferable that it is rotatable along the axis of.
That is, the thin film 3 is inverted and fed from the outer peripheral surface 11 to the inner peripheral surface 12 at the proximal end portion 13, and inverted and drawn out from the inner peripheral surface 12 to the outer peripheral surface 11 at the distal end portion 14 to be a catheter. It is rotatably provided along the long axis direction of the tube 2, and is characterized in that the static friction resistance between the inner surface of the thin film 3 and the catheter tube 2 is smaller than the static friction resistance between the outer surface of the thin film 3 and the mucous membrane 21 on the inner surface of the organ. ..
Further, it is preferable that the thin film 3 wraps the catheter tube 2 in a state of being lightly stretched so as not to wrinkle.

また、薄膜３は、合成高分子樹脂製の薄膜であることができる。更に、薄膜３は、合成高分子樹脂繊維又は天然高分子繊維で紡織された布製の薄膜であることができる。
薄膜３の厚さは、特に限定されるものではないが、本発明の薄膜３は、より薄い方が好ましいので、０．５ｍｍ以下であることが望ましい。しかし、薄膜３は薄すぎると強度の問題が生じることがあるので０．０１ｍｍ以上であることが好ましい。 Further, the thin film 3 can be a thin film made of a synthetic polymer resin. Further, the thin film 3 can be a cloth thin film woven from synthetic polymer resin fibers or natural polymer fibers.
The thickness of the thin film 3 is not particularly limited, but the thin film 3 of the present invention is preferably thinner, and therefore preferably 0.5 mm or less. However, if the thin film 3 is too thin, a problem of strength may occur, so that the thin film 3 is preferably 0.01 mm or more.

ここで、薄膜に使用される材料は、合成高分子樹脂の薄膜であることが好ましい。また、合成高分子樹脂又は天然高分子の繊維で紡織された布製の薄膜であることができる。具体的には、合成高分子樹脂としては、ポリエチレン、高分子ポリエチレン、超高分子量ポリエチレン、ポリプロピレン、ポリスチレン、ポリ塩化ビニル、ポリ酢酸ビニル、ポリアクリロニトリル、ポリアセタール、ポリエチレンテレフタレート、ポリカーボネート、ポリエステル樹脂、ポリメタクリル樹脂、ポリアミド樹脂、ポリイミド樹脂、フッ素樹脂、フェノール樹脂、尿素樹脂、メラミン樹脂、ポリウレタン樹脂、シリコーン樹脂、アルキッド樹脂、エポキシ樹脂などを含む１以上を挙げることができ、また天然高分子の繊維としては、絹を挙げることができるが、これらに限られるものではない。上記ポリマーは、単独で使用されても、２種以上の共重合体、混合物、複合膜等の形態で使用されてもよい。 Here, the material used for the thin film is preferably a thin film of synthetic polymer resin. Further, it can be a thin film made of cloth woven from synthetic polymer resin or natural polymer fiber. Specifically, the synthetic polymer resin includes polyethylene, polymer polyethylene, ultrahigh molecular weight polyethylene, polypropylene, polystyrene, polyvinyl chloride, vinyl acetate, polyacrylonitrile, polyacetal, polyethylene terephthalate, polycarbonate, polyester resin, and polymethacrylic. One or more including resin, polyamide resin, polyimide resin, fluororesin, phenol resin, urea resin, melamine resin, polyurethane resin, silicone resin, alkyd resin, epoxy resin, etc. can be mentioned, and natural polymer fibers include one or more. , Silk, but is not limited to these. The polymer may be used alone or in the form of two or more copolymers, mixtures, composite films and the like.

［静摩擦抵抗］
本発明の開口を有する臓器用無痛カテーテルは、薄膜３の内面とカテーテル管２との静摩擦抵抗が、開口を有する臓器内面の粘膜２１と薄膜３の外面との静摩擦抵抗より小さいことを特徴とする。
図２は、図１の遠位端部（点線で囲んだ楕円内）の部分拡大図であり、図３は、図１をＡ方向から見た部分内面図である。
図２に示すように、カテーテル管２を、体表に開口を有する臓器４に挿入する方向１５に押圧すると、カテーテル管２と薄膜の３との間の静摩擦抵抗が、臓器内面の粘膜２１と、薄膜３の外面１６との間の静摩擦抵抗より小さいため、カテーテル管２の内周面１２と薄膜３の内面１７との間が滑って薄膜３が移動方向１９に移動される。 [Stiction resistance]
The painless catheter for an organ having an opening of the present invention is characterized in that the static friction resistance between the inner surface of the thin film 3 and the catheter tube 2 is smaller than the static friction resistance between the mucous membrane 21 on the inner surface of the organ having an opening and the outer surface of the thin film 3. ..
FIG. 2 is a partially enlarged view of the distal end portion (inside the ellipse surrounded by the dotted line) of FIG. 1, and FIG. 3 is a partial internal view of FIG. 1 as viewed from the A direction.
As shown in FIG. 2, when the catheter tube 2 is pressed in the direction 15 to be inserted into the organ 4 having an opening on the body surface, the static friction resistance between the catheter tube 2 and the thin film 3 is increased with the mucous membrane 21 on the inner surface of the organ. Since it is smaller than the static friction resistance between the outer surface 16 of the thin film 3, the thin film 3 slides between the inner peripheral surface 12 of the catheter tube 2 and the inner surface 17 of the thin film 3 and is moved in the moving direction 19.

また、図２、３に示すように、本発明の体表の開口部と連通された臓器用無痛カテーテル１は、カテーテル管２の下面に接触する薄膜１８が、静摩擦抵抗の大きい臓器内面の粘膜２１と接触しながら移動されるので、体表の開口部を拡げる方向（移動方向１９）の力が生じる。これによって、カテーテル１が押圧されると、カテーテル管２は、臓器内面の粘膜２１をかき分けるようにして挿入され、カテーテル挿入時の患者の苦痛を軽減できるという特徴を有する。 Further, as shown in FIGS. Since it is moved while in contact with 21, a force is generated in the direction of expanding the opening on the body surface (movement direction 19). As a result, when the catheter 1 is pressed, the catheter tube 2 is inserted so as to squeeze the mucous membrane 21 on the inner surface of the organ, and has a feature that the patient's pain at the time of inserting the catheter can be reduced.

また、本発明の体表の開口部と連通された臓器用無痛カテーテル１は、近位端部１３において、薄膜３が、カテーテル管２の外周面１１側から内周面１２側に反転され拡張されながら繰り出されてカテーテル管２と臓器４との間に挿入され、カテーテル管２と臓器４との間の摩擦抵抗を軽減し、患者の苦痛を軽減することができるという特徴を有する。 Further, in the painless catheter 1 for organs communicated with the opening of the body surface of the present invention, the thin film 3 is inverted and expanded from the outer peripheral surface 11 side to the inner peripheral surface 12 side of the catheter tube 2 at the proximal end portion 13. It has a feature that it is drawn out while being extended and inserted between the catheter tube 2 and the organ 4, the frictional resistance between the catheter tube 2 and the organ 4 can be reduced, and the pain of the patient can be alleviated.

また、従来は、カテーテルを長期間留置した後に、カテーテル管２の外周面１１と臓器４の内面の粘膜２１とが癒着することがあって、カテーテルを抜去するときに患者に大きな苦痛を与えることがあった。
図４は、本発明のカテーテルの抜去方法を説明する図である。
図４に示すように、本発明は、カテーテル１を抜去する時に、カテーテル管２の内周面１２に接触する薄膜３を、カテーテル管の抜去方向２３に引っ張ってカテーテル管２を引き抜くことを特徴とする。
すなわち、薄膜３をカテーテル管の抜去方向２３に引っ張ると、カテーテル管２と薄膜３との間の静摩擦抵抗が、臓器内面の粘膜２１と薄膜の外面１６との間の静摩擦抵抗より小さいため、薄膜の内面１７とカテーテル管の内周面１２との間が滑って、カテーテル管２が抜去方向２４に移動される。この時、薄膜３の移動方向１９が、薄膜３を臓器内面の粘膜２１から引き剥がす方向に転向されて、たとえ薄膜３が臓器表面２１と癒着していても、薄膜３が移動方向１９に移動されながら薄膜３を癒着箇所からゆっくりと引きはがすことができ、カテーテル管２を抜去するときの苦痛を軽減できる。この時、カテーテル管２の移動速度と薄膜１６の移動速度との比は１：２である。また、カテーテル管２を先に引き抜き、後から薄膜１６を引き抜くこともできる。 Further, conventionally, after the catheter is indwelled for a long period of time, the outer peripheral surface 11 of the catheter tube 2 and the mucous membrane 21 on the inner surface of the organ 4 may adhere to each other, which causes great pain to the patient when the catheter is removed. was there.
FIG. 4 is a diagram illustrating a method for removing a catheter according to the present invention.
As shown in FIG. 4, the present invention is characterized in that when the catheter 1 is removed, the thin film 3 in contact with the inner peripheral surface 12 of the catheter tube 2 is pulled in the removal direction 23 of the catheter tube to pull out the catheter tube 2. And.
That is, when the thin film 3 is pulled in the removal direction 23 of the catheter tube, the static friction resistance between the catheter tube 2 and the thin film 3 is smaller than the static friction resistance between the mucous membrane 21 on the inner surface of the organ and the outer surface 16 of the thin film. The catheter tube 2 is moved in the removal direction 24 by sliding between the inner surface 17 of the catheter tube and the inner peripheral surface 12 of the catheter tube. At this time, the moving direction 19 of the thin film 3 is turned in the direction of peeling the thin film 3 from the mucous membrane 21 on the inner surface of the organ, and even if the thin film 3 is adhered to the organ surface 21, the thin film 3 moves in the moving direction 19. While doing so, the thin film 3 can be slowly peeled off from the adhesion portion, and the pain when removing the catheter tube 2 can be reduced. At this time, the ratio of the moving speed of the catheter tube 2 to the moving speed of the thin film 16 is 1: 2. Further, the catheter tube 2 can be pulled out first, and the thin film 16 can be pulled out later.

図１～４を参照しながら説明したように、本発明の体表の開口部と連通された臓器用無痛カテーテル１は、薄膜３とカテーテル管２との間の静摩擦抵抗が、臓器４の内面の粘膜２１と薄膜３の外面１６との間の静摩擦抵抗より小さいことが好ましい。
通常は、臓器４の内面の粘膜２１と薄膜３の外面１６との間の静摩擦抵抗は充分に大きく、また必要であれば薄膜３と粘膜２１との間の移動を禁止するストッパー１０を設けることができ、臓器４の内面の粘膜２１と薄膜２の外面とが実質的に固定されるように設定できる。
ここで、ストッパー１０は、カテーテル管２の外周面に接触する薄膜１６がカテーテルを体表の開口部と連通された臓器に挿入する方向１５に移動するのを阻止する構造であればよく、例えば図１に示すように、薄膜３の開口部６に接触する部分に固定して設けられたリング状のストッパー１０であることができる。 As described with reference to FIGS. 1 to 4, in the painless catheter 1 for an organ communicated with the opening of the body surface of the present invention, the static friction resistance between the thin film 3 and the catheter tube 2 causes the inner surface of the organ 4. It is preferably smaller than the static friction resistance between the mucous membrane 21 and the outer surface 16 of the thin film 3.
Normally, the static friction resistance between the inner surface mucosa 21 of the organ 4 and the outer surface 16 of the thin film 3 is sufficiently large, and if necessary, a stopper 10 for prohibiting movement between the thin film 3 and the mucous membrane 21 is provided. The mucous membrane 21 on the inner surface of the organ 4 and the outer surface of the thin film 2 can be set to be substantially fixed.
Here, the stopper 10 may have a structure that prevents the thin film 16 in contact with the outer peripheral surface of the catheter tube 2 from moving in the direction 15 for inserting the catheter into the organ communicated with the opening of the body surface , for example. As shown in FIG. 1, it can be a ring-shaped stopper 10 fixedly provided at a portion of the thin film 3 in contact with the opening 6.

一方、薄膜３の内面とカテーテル管２の外周面１１との間の静摩擦抵抗係数は、０．４以下であることが好ましく、０．３以下であることがより好ましく０．２５以下であることが更に好ましい。薄膜３の内面とカテーテル管２の外周面１１との間の静摩擦抵抗係数が０．４を超えると、カテーテル管２を臓器４に挿入する力が少ししか軽減されず、患者の苦痛を十分に軽減することができないことがある。 On the other hand, the static drag coefficient between the inner surface of the thin film 3 and the outer peripheral surface 11 of the catheter tube 2 is preferably 0.4 or less, more preferably 0.3 or less, and 0.25 or less. Is more preferable. When the drag coefficient of static friction between the inner surface of the thin film 3 and the outer peripheral surface 11 of the catheter tube 2 exceeds 0.4, the force for inserting the catheter tube 2 into the organ 4 is slightly reduced, and the patient's pain is sufficiently reduced. It may not be possible to mitigate.

ところで、静摩擦抵抗係数は、２物質の組み合わせの性質に関する値であり、更に両物質の表面の状態、両物質の履歴等の影響を受ける。各物質間の静摩擦抵抗係数の標準値は、文献的に求めることはできないので、本発明は、非特許文献１、２に記載の方法で測定した測定値を静摩擦抵抗係数として用いることにする。 By the way, the static friction coefficient is a value relating to the properties of the combination of the two substances, and is further affected by the surface condition of both substances, the history of both substances, and the like. Since the standard value of the static friction resistance coefficient between each substance cannot be obtained in the literature, the present invention uses the measured value measured by the methods described in Non-Patent Documents 1 and 2 as the static friction resistance coefficient.

［静摩擦抵抗係数の測定］
図５は、本発明の静摩擦抵抗係数の測定方法を説明する図である。
図５に示すように、本発明の静摩擦抵抗係数の測定法は、水平に設けられた基台１３０の上面に破線で示す平らな基板１４０を載置し、該基板１４０の上面に破線で示す薄膜の素材１２０をしわにならないように固定し、薄膜の素材１２０の上面に破線で示すカテーテルの素材１１０を載置し、カテーテルの素材１１０の下面中央付近に高さ測定点１０１を設ける。
次いで、基板１４０の一端１４１を振動させないようにゆっくりと持ち上げて、カテーテルの素材１１０が滑り始めた時点（図５の実線部分）における高さ測定点１０１の鉛直線と基台１３０の上面との交点を距離測定点１０２とし、薄膜の素材１２０上面の仮想延長面１２２と基台１３０上面（又はその仮想延長面）とが交差する直線を１００、１００とする。
高さ測定点１０１と距離測定点１０２との距離をＡとし、距離測定点１０２と直線１００、１００との距離をＢとし、μ＝Ａ／Ｂを計算すると、μがカテーテルの素材１１０と薄膜の素材１２０との静摩擦抵抗係数となる。本発明では、測定を１０回行い、測定値を幾何平均して静摩擦抵抗係数とした。 [Measurement of static friction resistance coefficient]
FIG. 5 is a diagram illustrating a method for measuring the static friction resistance coefficient of the present invention.
As shown in FIG. 5, in the method for measuring the static friction resistance coefficient of the present invention, a flat substrate 140 shown by a broken line is placed on the upper surface of a horizontally provided base 130, and the flat substrate 140 shown by a broken line is shown on the upper surface of the substrate 140 by a broken line. The thin film material 120 is fixed so as not to wrinkle, the catheter material 110 shown by the broken line is placed on the upper surface of the thin film material 120, and the height measurement point 101 is provided near the center of the lower surface of the catheter material 110.
Next, the one end 141 of the substrate 140 is slowly lifted so as not to vibrate, and the vertical line of the height measurement point 101 at the time when the material 110 of the catheter starts to slide (the solid line portion in FIG. 5) and the upper surface of the base 130 The intersection is the distance measurement point 102, and the straight lines where the virtual extension surface 122 on the upper surface of the thin film material 120 and the upper surface of the base 130 (or the virtual extension surface thereof) intersect are 100 and 100.
When the distance between the height measurement point 101 and the distance measurement point 102 is A, the distance between the distance measurement point 102 and the straight lines 100 and 100 is B, and μ = A / B is calculated, μ is the material 110 of the catheter and the thin film. It becomes the static friction resistance coefficient with the material 120 of. In the present invention, the measurement was performed 10 times, and the measured values were geometrically averaged to obtain the static friction resistance coefficient.

更に、前記薄膜３は、カテーテル管２と対向する面との静摩擦抵抗が小さくなる形状に形成することができる。薄膜３とカテーテル管２との静摩擦抵抗が小さくなるような形状の例として、薄膜３の表面にカテーテル管２の軸方向と平行な線状突起又は溝を設けることができる。また、薄膜３とカテーテル管２との間に潤滑剤を添加することができる。 Further, the thin film 3 can be formed into a shape in which the static friction resistance between the catheter tube 2 and the surface facing the catheter tube 2 is reduced. As an example of a shape in which the static friction resistance between the thin film 3 and the catheter tube 2 is small, a linear protrusion or groove parallel to the axial direction of the catheter tube 2 can be provided on the surface of the thin film 3. Further, a lubricant can be added between the thin film 3 and the catheter tube 2.

図６は、本発明の１実施形態に係る、カテーテルを体表の開口部と連通された臓器へ挿入する方法を説明する図である。
図６Ａに示すように、カテーテル管２の遠位端部１４を体表の開口部６に押し当てて挿入する方向１５に押圧することにより、図６Ｂ、Ｃに示すように、カテーテル１を小さな押圧力で前記臓器に挿入し得る。このとき、図２、３で示したように、カテーテル管２の遠位端部１４において薄膜３が、カテーテル管２の内周面１２から外周面１１に反転され拡張されながら繰り出されて臓器４の体表の開口部６を拡張すると共に、カテーテル管２と臓器４との間に挿入され、カテーテル管２と臓器内面の粘膜２１との間に挿入されて患者の苦痛を軽減することができる。 FIG. 6 is a diagram illustrating a method of inserting a catheter into an organ communicated with an opening on the body surface according to one embodiment of the present invention.
As shown in FIGS. 6A, the distal end 14 of the catheter tube 2 is pressed against the opening 6 on the body surface and pressed in the insertion direction 15 to reduce the size of the catheter 1 as shown in FIGS. 6B and 6C. It can be inserted into the organ by pressing force. At this time, as shown in FIGS. The opening 6 on the body surface of the body can be expanded and inserted between the catheter tube 2 and the organ 4 and inserted between the catheter tube 2 and the mucous membrane 21 on the inner surface of the organ to alleviate the patient's pain. ..

＜実施例１＞
［静摩擦係数の測定］
１）図５に示すように、水平な基台１３０の上に、薄膜２の素材であるポリエチレン薄膜１２０（長さ２５０ｍｍ×幅１００ｍｍ×厚さ０．５ｍｍ）を固定した基板１４０（長さ３００ｍｍ×幅１００ｍｍ）を載せ、ポリエチレン薄膜１２０にカテーテル管２の素材である下面が平らなシリコーン樹脂１１０（縦５０ｍｍ×横５０ｍｍ×高さ２０ｍｍ）を載置し、シリコーン樹脂１１０の下面中央付近に高さ測定点１０１を設定した。
２）基板１４０の一端１４１を、振動しないよう静かに５～３０ｃｍ／分の速度で持ち上げた。
シリコーン樹脂１１０が滑り始めた時点の、ポリエチレン薄膜１２０上面の他端方向への仮想延長面１２２と基台１３０上面とが交差して形成する直線を１００、１００とし、高さ測定点１０１の垂直下方の基台１３０の点を距離測定点１０２とした。
３）高さ測定点１０１と距離測定点１０２との距離（Ａ）と距離測定点１０２と直線１００、１００と距離（Ｂ）とを測定し、カテーテルの素材１１０と薄膜の素材１２０との静摩擦抵抗係数μ＝Ａ／Ｂを１０回計測し測定値の幾何平均を計算したところ、シリコーン樹脂とポリエチレン薄膜との静摩擦抵抗係数μ＝Ａ／Ｂは、０．２１であった。 <Example 1>
[Measurement of static friction coefficient]
1) As shown in FIG. 5, a substrate 140 (length 300 mm) in which a polyethylene thin film 120 (length 250 mm × width 100 mm × thickness 0.5 mm) which is a material of the thin film 2 is fixed on a horizontal base 130. × width 100 mm) is placed, and a silicone resin 110 (length 50 mm × width 50 mm × height 20 mm) having a flat lower surface, which is the material of the catheter tube 2, is placed on the polyethylene thin film 120, and the height is near the center of the lower surface of the silicone resin 110. The measurement point 101 was set.
2) One end 141 of the substrate 140 was gently lifted at a speed of 5 to 30 cm / min so as not to vibrate.
The straight lines formed by the intersection of the virtual extension surface 122 toward the other end of the upper surface of the polyethylene thin film 120 and the upper surface of the base 130 at the time when the silicone resin 110 starts to slide are set to 100 and 100, and are perpendicular to the height measurement point 101. The point of the lower base 130 was designated as the distance measurement point 102.
3) Measure the distance (A) between the height measurement point 101 and the distance measurement point 102, the distance measurement point 102 and the straight line 100, 100 and the distance (B), and static friction between the catheter material 110 and the thin film material 120. When the resistance coefficient μ = A / B was measured 10 times and the geometric average of the measured values was calculated, the static friction resistance coefficient μ = A / B between the silicone resin and the polyethylene thin film was 0.21.

＜比較例１＞
実施例１と同様に、但しカテーテルの素材としてポリウレタン樹脂を用い、薄膜の素材としてポリアミド樹脂を用いてポリウレタン樹脂とポリアミド樹脂との静摩擦抵抗係数を測定したところ、静摩擦抵抗係数μ＝Ａ／Ｂは、０．４３であった。 <Comparative Example 1>
Similar to Example 1, however, when a polyurethane resin was used as the material of the catheter and a polyamide resin was used as the material of the thin film, the static friction resistance coefficient between the polyurethane resin and the polyamide resin was measured, and the static friction resistance coefficient μ = A / B was obtained. , 0.43.

［カテーテル］
＜実施例２＞
カテーテル管の素材として実施例１と同じシリコーン樹脂を用い、薄膜３の素材としてポリエチレン樹脂を用いて図１と同じ形状の、外径が５．３ｍｍであって、管の長さが３５０ｍｍであり、薄膜として用いたポリエチレン樹脂の厚さが０．２ｍｍである尿排出を目的とした男性用尿道カテーテルを製造した。
実施例２で製造した尿道カテーテルを、尿道カテーテル使用経験のある男性患者の尿道に自分で挿入させて使用感を聞いたところ、実施例２のカテーテルは、通常よりやや太いため見た目の違和感と粘膜の圧迫感はあるものの、挿入が容易であり痛みもほとんどないから、自力で挿入可能であるとの評価を得た。
実施例２のカテーテルは、近位端部において、薄膜の上から操作部が接続可能であり、操作部を介して排出尿の貯留、バルーン膜の操作、消毒液の供給、カテーテルを通しての投薬等の機能を追加することが可能である。 [catheter]
<Example 2>
Using the same silicone resin as in Example 1 as the material of the catheter tube and polyethylene resin as the material of the thin film 3, the same shape as in FIG. 1, the outer diameter is 5.3 mm, and the length of the tube is 350 mm. , A men's urinary tract catheter for urine discharge having a thickness of 0.2 mm of polyethylene resin used as a thin film was manufactured.
When the urethral catheter manufactured in Example 2 was inserted into the urethra of a male patient who had used the urinary catheter by himself and asked about the feeling of use, the catheter of Example 2 was slightly thicker than usual, so that it looked strange and mucous membrane. Although there is a feeling of oppression, it is easy to insert and there is almost no pain, so it was evaluated that it can be inserted by itself.
In the catheter of Example 2, the operation unit can be connected from above the thin film at the proximal end, and the accumulated urine is accumulated through the operation unit, the balloon membrane is operated, the disinfectant is supplied, the medication is administered through the catheter, and the like. It is possible to add the function of.

＜比較例２＞
カテーテル管の素材として、比較例２と同様に、カテーテル管用の素材としてポリウレタン樹脂を用い、薄膜用の素材として圧さ０．１ｍｍのポリアミド樹脂を用いて実施例２と同様の男性用尿道カテーテルを製造し、実施例２と同じ患者の尿道に自分で挿入させて感想を聞いたところ、比較例２のカテーテルは、痛くて自力では挿入できないとのことであった。 <Comparative Example 2>
As the material of the catheter tube, polyurethane resin was used as the material for the catheter tube as in Comparative Example 2, and the polyamide resin having a pressure of 0.1 mm was used as the material for the thin film, and the same male urinary catheter as in Example 2 was used. When the catheter was manufactured and inserted into the urethra of the same patient as in Example 2 by itself and the impression was heard, it was found that the catheter of Comparative Example 2 was painful and could not be inserted by itself.

以上、本発明に関する好ましい実施形態を説明したが、本発明は前記実施形態に限定されず、本発明の属する技術範囲を逸脱しない範囲での全ての変更が含まれる。 Although the preferred embodiment of the present invention has been described above, the present invention is not limited to the above embodiment and includes all modifications within the range not departing from the technical scope to which the present invention belongs.

１カテーテル
２カテーテル管
３薄膜
４（体表の開口部と連通された）臓器
５体表
６体表の開口部
７体内
１０ストッパー
１１外周面
１２内周面
１３近位端部
１４遠位端部
１５カテーテル管を（体表の開口部と連通された）臓器に挿入する方向
１６薄膜の外面
１７薄膜の内面
１８カテーテル管の下面に接触する薄膜
１９薄膜の移動方向
２１（体表の開口部と連通された）臓器内面の粘膜
２３薄膜の移動方向
２４カテーテル管の抜去方向
１００直線
１０１高さ測定点
１０２距離測定点
１１０カテーテルの素材
１２０薄膜の素材
１３０基台
１４０基板 1 Cauterus 2 Cauterus tube 3 Thin film 4 ( Communicated with the opening on the body surface) Organ 5 Body surface 6 Opening on the body surface 7 Inside the body 10 Stopper 11 Outer peripheral surface 12 Inner peripheral surface 13 Proximal end 14 Distal end 15 Direction of inserting the catheter tube into the organ (communication with the opening of the body surface ) 16 Outer surface of the thin film 17 Inner surface of the thin film 18 Thin film in contact with the lower surface of the catheter tube 19 Direction of movement of the thin film 21 ( with the opening of the body surface) Mucosa on the inner surface of the organ (communicated) 23 Direction of movement of the thin film 24 Direction of removal of the catheter tube 100 Straight 101 Height measurement point 102 Distance measurement point 110 Cauterine material 120 Thin film material 130 Base 140 Substrate

Claims

体表の開口部と連通された臓器の前記開口部から前記臓器の内部に挿入されるカテーテル管と、
前記カテーテル管の外周面を覆っている円筒形の一端を前記カテーテル管の近位端部で前記外周面側から内周面側に反転させて前記内周面側に繰り込み、前記内周面側を通して遠位端部に供給し、前記遠位端部で外側に反転させ、前記外周面に導出し、導出された前記一端を前記外周面を覆っている他端部に連結させた端部のない二重円筒形であって前記カテーテル管の長軸方向に沿って回転可能に設けられた薄膜と、
を有し、
前記薄膜の内面と前記カテーテル管との間の静摩擦抵抗が、前記薄膜の外面と前記臓器内面の粘膜との間の静摩擦抵抗より小さく、０．４以下であることを特徴とする体表の開口部と連通された臓器用無痛カテーテル。 A catheter tube inserted into the inside of the organ through the opening of the organ communicated with the opening of the body surface ,
One end of the cylinder covering the outer peripheral surface of the catheter tube is inverted from the outer peripheral surface side to the inner peripheral surface side at the proximal end of the catheter tube and fed into the inner peripheral surface side, and the inner peripheral surface side is provided. It is supplied to the distal end portion through , inverted outward at the distal end portion, led out to the outer peripheral surface, and the derived end is connected to the other end portion covering the outer peripheral surface. A thin film that is a double cylinder without a portion and is rotatably provided along the long axis direction of the catheter tube.
Have,
The static friction resistance between the inner surface of the thin film and the catheter tube is smaller than the static friction resistance between the outer surface of the thin film and the mucous membrane of the inner surface of the organ , and is 0.4 or less . Painless catheter for organs communicated with the opening.

前記薄膜が、柔軟性及び伸縮性を有し、軽く引き延ばされた状態で前記カテーテル管を包んでいることを特徴とする請求項１に記載の体表の開口部と連通された臓器用無痛カテーテル。 The thin film has flexibility and elasticity, and wraps the catheter tube in a lightly stretched state. For an organ communicated with an opening of a body surface according to claim 1. Painless catheter.

前記薄膜は、合成高分子樹脂製の薄膜であることを特徴とする請求項１又は２に記載の体表の開口部と連通された臓器用無痛カテーテル。 The painless catheter for an organ communicated with the opening of the body surface according to claim 1 or 2, wherein the thin film is a thin film made of a synthetic polymer resin.

前記薄膜は、合成高分子樹脂繊維、又は天然高分子繊維で紡織された布製の薄膜であることを特徴とする請求項１乃至３のいずれか１項に記載の体表の開口部と連通された臓器用無痛カテーテル。 The thin film is communicated with the opening of the body surface according to any one of claims 1 to 3, wherein the thin film is a thin film made of cloth woven from synthetic polymer resin fibers or natural polymer fibers. Painless catheter for organs.

前記薄膜は、厚さが０．５ｍｍ以下であることを特徴とする請求項１乃至４のいずれか１項に記載の体表の開口部と連通された臓器用無痛カテーテル。 The painless catheter for an organ communicated with the opening of the body surface according to any one of claims 1 to 4, wherein the thin film has a thickness of 0.5 mm or less.

前記薄膜は、外面と前記臓器内面の粘膜との間に、相互の滑り移動を阻止するストッパーを更に備えることを特徴とする請求項５に記載の体表の開口部と連通された臓器用無痛カテーテル。
The painless organ communication with the opening of the body surface according to claim 5, wherein the thin film further comprises a stopper between the outer surface and the mucous membrane on the inner surface of the organ to prevent mutual sliding movement. catheter.