JP2011139746A - Sphincter device - Google Patents

Sphincter device Download PDF

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JP2011139746A
JP2011139746A JP2010001068A JP2010001068A JP2011139746A JP 2011139746 A JP2011139746 A JP 2011139746A JP 2010001068 A JP2010001068 A JP 2010001068A JP 2010001068 A JP2010001068 A JP 2010001068A JP 2011139746 A JP2011139746 A JP 2011139746A
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anus
sphincter
head
sphincter device
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JP4725868B1 (en
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Sachitaka Omachi
祥孝 大間知
Masayuki Nishitani
雅之 西谷
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Abstract

<P>PROBLEM TO BE SOLVED: To eliminate the switching operation of opening/closing a tubular region by a device including a body enclosing the tubular region such as the anus and an energizing means for blocking the tubular region with such energization force that the tubular region can be dilated when the content in the tubular region is pushed downstream with abdominal pressure, to suppress burdens on the human body by reducing the number of components, and to improve the maintainability and economical efficiency by simplifying the structure of the device. <P>SOLUTION: The body 2 formed of long-length silicone rubber for enclosing and blocking the anus K energizes the anus K in the blocking direction with such energization force F as to ream the anus K when the content N within the anus K on the upstream side of the body 2 is pushed downstream with abdominal pressure. The body 2 includes a connecting means 4 for connecting one end 2a to the other end 2b when the anus K is enclosed in such a way that the enclosing length L is adjustable. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

本発明は、肛門、尿道などの器官の管部周囲に配置された括約筋装置に関するものである。   The present invention relates to a sphincter device disposed around a tube portion of an organ such as an anus or urethra.

従来、器官の管部のために人体に埋没可能な人工括約筋装置が知られている。
この人工括約筋装置は、管部の周りに配置されるようになっており、膨張時に管部の周りに閉じ且つ管部を閉鎖し、且つ収縮時に管部を開く膨張可能な可撓性カフと、カフの周りに配置され且つカフに締着され、且つ膨張時管部から外方へ真直ぐにされ且つ開くように処置された膨張可能な可撓性リザバーリングと、カフ及びリングを相互連結する流体通路と、流体をカフからリザバーリングへ移送する装置とを備えている（特許文献１参照）。 2. Description of the Related Art Conventionally, an artificial sphincter device that can be buried in a human body for an organ tube is known.
The artificial sphincter device is adapted to be placed around a tube portion, an inflatable flexible cuff that closes and closes the tube portion when inflated and opens the tube portion when contracted. Interconnecting the cuff and the ring with an inflatable flexible reservoir ring disposed about the cuff and fastened to the cuff and straightened outwardly from the tube when inflated and treated to open A fluid passage and a device for transferring fluid from the cuff to the reservoir ring are provided (see Patent Document 1).

特公平６−３８８０８号公報Japanese Examined Patent Publication No. 6-38808

上記従来の人工括約筋装置は、管部を開閉させるためには、その都度ポンプや加熱回路を切換操作しなくてはならない構造であって、排泄時の操作性が悪い。
また、管部を開閉するカフ以外に、上述のポンプ及び加熱回路や、リザバーリング、３つの流体伝達ライン、運動制御リング及びコイルなどの多くの部材を体内の複数箇所に埋め込む必要があり、人体に大きな侵襲を負わせる。 The conventional artificial sphincter device has a structure in which the pump and the heating circuit must be switched each time to open and close the tube portion, and the operability during excretion is poor.
In addition to the cuff that opens and closes the pipe, it is necessary to embed many members such as the pump and heating circuit, the reservoir ring, the three fluid transmission lines, the motion control ring, and the coil at multiple locations in the body. Can be very invasive.

さらに、人工括約筋装置から体内に流体が漏れたり、電気回路が故障するなどの虞や、構造が複雑なためにメンテナンスの困難性やコスト高などの問題もある。
本発明は、このような問題点に鑑みて、器官の管部を取り囲む本体より上流側で且つ管部内の内容物を腹圧で下流へ押圧することによって拡開可能に管部を閉塞する付勢手段を有することで、管部を開閉する切換操作を必要とせず、部品点数の減少及び構造の簡素化を実現して、人体にかかる侵襲を低く抑え、メンテナンス性及び経済性を上げ、括約筋機能が低下した患者の生活の質を向上させる括約筋装置を提供することを目的とする。 In addition, there is a risk of fluid leaking from the artificial sphincter device into the body or failure of an electric circuit, and problems such as difficulty in maintenance and high costs due to the complicated structure.
In view of such a problem, the present invention attaches the tube portion so that the tube portion can be expanded by pressing the contents in the tube portion downstream from the main body surrounding the tube portion of the organ and the abdominal pressure. By having a biasing means, switching operation to open and close the pipe part is not required, reducing the number of parts and simplifying the structure, keeping the invasion on the human body low, improving maintenance and economy, and sphincter The object is to provide a sphincter device that improves the quality of life of patients with reduced function.

前記課題を達成するために、本発明は、以下の技術的手段を採用した。
第１に、器官の管部Ｋを取り囲んで閉塞した本体２と、この本体２より上流側且つ前記管部Ｋ内の内容物Ｎを腹圧で下流へ押圧した際に前記管部Ｋが拡開可能な付勢力Ｆで前記管部Ｋを閉塞方向に付勢した付勢手段３とを有していることを特徴とする。
第２に、前記管部Ｋは、肛門Ｋであって、
前記付勢手段３を、長尺のシリコンゴムで形成された前記本体２によって構成し、
前記本体２は、前記肛門Ｋを取り囲んだ時に一端部２ａと他端部２ｂとを連結する連結手段４を囲い長さＬ調整自在に備えていることを特徴とする。 In order to achieve the above object, the present invention employs the following technical means.
First, the main body 2 surrounding and closing the tube portion K of the organ, and the tube portion K expands when the contents N in the tube portion K upstream of the main body 2 are pressed downstream by abdominal pressure. And an urging means 3 that urges the tube portion K in the closing direction with an urging force F that can be opened.
Second, the tube K is an anus K,
The urging means 3 is constituted by the main body 2 formed of a long silicon rubber,
The main body 2 includes a connecting means 4 for connecting the one end portion 2a and the other end portion 2b when the anus K is surrounded, so that the length L is adjustable.

第３に、前記付勢力Ｆを、前記本体２で肛門Ｋを取り囲んだ時の肛門静止圧Ｓが２０ｍｍＨｇ以上１２０ｍｍＨｇ以下となるように設定していることを特徴とする。
これらの特徴により、管部Ｋを取り囲む本体２と、管部Ｋ内の内容物Ｎを腹圧で下流へ押圧した際に拡開可能な付勢力Ｆで管部Ｋを閉塞する付勢手段３とを有することで、特段の操作なしに管部Ｋの開閉が可能となり、使用者Ｐの煩雑さを低減できる。そして、必要な部品点数を減らして人体への負担を抑えるとともに、簡単な構造となるためメンテナンスの必要がほとんどなく且つコストを低く抑えることができ、使用者Ｐの生活の質を向上させる。 Thirdly, the urging force F is set so that an anal static pressure S when the body 2 surrounds the anus K is 20 mmHg or more and 120 mmHg or less.
Due to these characteristics, the main body 2 surrounding the pipe part K and the urging means 3 for closing the pipe part K with an urging force F that can be expanded when the contents N in the pipe part K are pressed downstream by abdominal pressure. The tube portion K can be opened and closed without any special operation, and the complexity of the user P can be reduced. And while reducing the number of necessary parts and reducing the burden on the human body, since it has a simple structure, there is almost no need for maintenance and the cost can be kept low, and the quality of life of the user P is improved.

また、付勢手段３を、長尺のシリコンゴムで形成された本体２で付勢手段３を構成することで、さらなる部品点数の減少及び管部Ｋである肛門Ｋ周囲への埋め込みの容易化を図り、肛門Ｋを取り囲んだ状態で本体２の一端部２ａと他端部２ｂとを連結する連結手段４を囲い長さＬ調整自在に備えることで、肛門Ｋを閉塞する付勢力Ｆを使用者Ｐに応じて調整することができる。   Further, the urging means 3 is constituted by the main body 2 formed of a long silicon rubber, thereby further reducing the number of parts and facilitating implantation around the anus K that is the tube portion K. The urging force F that closes the anus K is used by providing the connecting means 4 that connects the one end 2a and the other end 2b of the main body 2 with the length L adjustable while surrounding the anus K. Can be adjusted according to the person P.

さらに、本体２で肛門Ｋを取り囲んだ時の肛門静止圧Ｓが２０ｍｍＨｇ以上１２０ｍｍＨｇ以下となるように付勢力Ｆを設定することで、内容物Ｎの漏れを防止すると同時に、適度な腹圧で容易に肛門Ｋを拡開できるようになる。   Furthermore, by setting the urging force F so that the anal static pressure S when the anus K is surrounded by the main body 2 is 20 mmHg or more and 120 mmHg or less, leakage of the contents N is prevented and at the same time easy with moderate abdominal pressure The anus K can be expanded.

本発明に係る括約筋装置によると、管部を取り囲んだ本体と、管部内の内容物を腹圧で下流へ押圧した際に管部が拡開可能な付勢力で管部を閉塞付勢した付勢手段とを有することで、管部の開閉に伴う煩雑な切換操作をなくし、部品点数の減少によって侵襲を抑え、構造の簡素化によってメンテナンス性及び経済性の向上を図ることができる。   According to the sphincter apparatus according to the present invention, the main body that surrounds the pipe section and the biasing force that closes and biases the pipe section with a biasing force that allows the pipe section to expand when the contents in the pipe section are pressed downstream by abdominal pressure. By having the biasing means, it is possible to eliminate a complicated switching operation associated with the opening and closing of the pipe part, to suppress the invasion by reducing the number of parts, and to improve the maintainability and economy by simplifying the structure.

第１実施形態に係る括約筋装置を体内に埋め込んだ際の斜視図である。It is a perspective view at the time of embedding the sphincter apparatus which concerns on 1st Embodiment in a body. 括約筋装置の平面図である。It is a top view of a sphincter device. 括約筋装置の側面図である。It is a side view of a sphincter device. 括約筋装置の使用態様を示す概要図である。It is a schematic diagram which shows the usage condition of a sphincter device. 第２実施形態に係る括約筋装置の平面図である。It is a top view of the sphincter device concerning a 2nd embodiment. 括約筋装置の側面図である。It is a side view of a sphincter device. 括約筋装置の使用態様を示す概要図である。It is a schematic diagram which shows the usage condition of a sphincter device.

以下、本発明の実施の形態を図面を参照して説明する。
図１〜４には、本発明の第１実施形態に係る括約筋装置１が示されている。
この括約筋装置１は、略紐状でのシリコンゴムであって、使用者（患者）Ｐの肛門Ｋを取り囲むように体内に埋め込まれ、長手方向に伸縮自在に形成されている。
括約筋装置１は、長尺の本体２と、この本体２の一端部２ａ及び他端部２ｂを連結する連結手段４と、本体２の一端部２ａに設けられた頭部１１と、本体２の他端部２ｂに設けられた尾部１２とを一体として形成している。 Hereinafter, embodiments of the present invention will be described with reference to the drawings.
1-4 show a sphincter device 1 according to a first embodiment of the present invention.
This sphincter device 1 is a substantially string-like silicone rubber, is embedded in the body so as to surround an anus K of a user (patient) P, and is formed to be stretchable in the longitudinal direction.
The sphincter device 1 includes a long main body 2, connecting means 4 for connecting one end 2 a and the other end 2 b of the main body 2, a head 11 provided at one end 2 a of the main body 2, The tail part 12 provided in the other end part 2b is integrally formed.

なお、括約筋装置１の硬度は、頭部１１及び後述の連結突起１４は硬度４０°であり、これら以外の部分は硬度２０°となっている。また、本発明における硬度の単位は、「ＪＩＳ Ｋ ６２５３」や「ＩＳＯ４８」、「ＩＳＯ７６１９」に準拠している。
図２、３に示すように、本体２は、肛門Ｋを取り囲みうる所定長さ（本実施形態では約８５ｍｍ）を有した略帯状であって、所定の左右幅（約１０ｍｍ）、厚み（約２ｍｍ）とすることで、本体２の伸縮性を十分に確保できる。また、本体２は、一端部２ａ側に複数穿設された連結孔１３（本実施形態では５つ）と、他端部２ｂ側に複数突設された連結突起１４（本実施形態では２つ）とを有している。 The sphincter device 1 has a hardness of 40 ° at the head 11 and a connecting projection 14 described later, and a hardness of 20 ° at other portions. The unit of hardness in the present invention is in conformity with “JIS K 6253”, “ISO48”, and “ISO7619”.
As shown in FIGS. 2 and 3, the main body 2 has a substantially band shape having a predetermined length (about 85 mm in the present embodiment) that can surround the anus K, and has a predetermined left-right width (about 10 mm) and thickness (about about 2 mm), the stretchability of the main body 2 can be sufficiently secured. The main body 2 includes a plurality of connecting holes 13 (five in this embodiment) drilled on one end 2a side and a plurality of connecting projections 14 (two in this embodiment) projecting on the other end 2b side. ).

連結孔１３は、後述する連結突起１４の突起胴部１４ａよりも小さい直径（約１ｍｍ）であって、本体２の一端縁から所定間隔（約５ｍｍ）ごと複数箇所に穿孔されている。
連結突起１４は、本体２の上面から立設した突起胴部１４ａと、この突起胴部１４ａの上端に設けられたフランジ状の突起頭部１４ｂとを有している。突起胴部１４ａは、略円柱状であって、直径は前記連結孔１３よりも大径（約２ｍｍ）で、高さが本体２の厚みと略同じ（約２ｍｍ）である。突起頭部１４ｂは、突起胴部１４ａよりも大径（約４ｍｍ）の略円盤状であって、後述するように連結突起１４を連結孔１３に通した際、突起頭部１４ｂ自体が弾性変形して抜けないような所定の厚さ（約１ｍｍ）を有している。 The connection hole 13 has a diameter (about 1 mm) smaller than a protrusion body portion 14a of the connection protrusion 14 to be described later, and is drilled at a plurality of locations at predetermined intervals (about 5 mm) from one end edge of the main body 2.
The connection protrusion 14 has a protrusion body portion 14 a erected from the upper surface of the main body 2 and a flange-shaped protrusion head portion 14 b provided at the upper end of the protrusion body portion 14 a. The protrusion body portion 14a has a substantially cylindrical shape, and has a diameter larger than that of the connection hole 13 (about 2 mm) and a height substantially the same as the thickness of the main body 2 (about 2 mm). The protruding head 14b has a substantially disk shape with a larger diameter (about 4 mm) than the protruding body 14a. When the connecting protrusion 14 is passed through the connecting hole 13 as will be described later, the protruding head 14b itself is elastically deformed. And has a predetermined thickness (about 1 mm) so as not to come off.

連結突起１４は、シリコンゴムで本体２と一体的に形成されており、連結孔１３は径方向に、連結突起１４は径方向及び軸心方向に伸び縮み自在である。
つまり、連結突起１４は、連結孔１３を拡開して本体２の下面から入れ込み、突起頭部１４ｂを本体２上面側に出すことができ、これによって、連結突起１４の連結孔１３に対する抜け止めがなされる。 The connection protrusion 14 is formed integrally with the main body 2 with silicon rubber, and the connection hole 13 can expand and contract in the radial direction, and the connection protrusion 14 can expand and contract in the radial direction and the axial direction.
That is, the connecting projection 14 can be inserted from the lower surface of the main body 2 by expanding the connecting hole 13, and the protruding head 14 b can be brought out to the upper surface side of the main body 2, thereby preventing the connecting projection 14 from coming off from the connecting hole 13. Is made.

また、２つの連結突起１４を５つ中２つの連結孔１３に挿入することで、本体２で肛門Ｋを取り囲んだ状態で本体２の一端部２ａと他端部２ｂとがリング状に連結される。
つまり、連結孔１３と連結突起１４とで連結手段４を構成している。
また、本体２が２カ所で抜け止めされるため、両端部２ａ、２ｂ連結時の本体２の向き決め（一端部２ａにおける長手方向と、他端部２ｂにおける長手方向とを略揃えること）が可能となる。 Further, by inserting the two connecting projections 14 into the two connecting holes 13 out of the five, the one end 2a and the other end 2b of the main body 2 are connected in a ring shape with the main body 2 surrounding the anus K. The
That is, the connection means 4 is constituted by the connection hole 13 and the connection protrusion 14.
Further, since the main body 2 is prevented from coming off at two locations, the orientation of the main body 2 when the both end portions 2a and 2b are connected (the longitudinal direction at the one end portion 2a and the longitudinal direction at the other end portion 2b are substantially aligned). It becomes possible.

さらに、連結突起１４を挿入する連結孔１３を５つの内から２つ選択可能であるため、本体２は、連結手段４によって肛門Ｋの取り囲む長さ（周長さ）Ｌを調整自在に構成されている。
図２、３に示す如く、頭部１１は、本体２の一端部２ａから前方に延設していて、幅及び厚みが前記本体２と略同一（幅が約１０ｍｍ、厚みが略２ｍｍ）の略平板状である。頭部１１の長さは、後述するように、括約筋装置１が体内で進む際に頭部１１を鉗子（ペアン鉗子等）２０で掴むのに必要な所定長さ（約２０ｍｍ）を有している。 Furthermore, since two connection holes 13 for inserting the connection protrusions 14 can be selected from among the five, the main body 2 is configured such that the length (circumferential length) L surrounding the anus K can be adjusted by the connection means 4. ing.
As shown in FIGS. 2 and 3, the head 11 extends forward from one end 2 a of the main body 2, and has the same width and thickness as the main body 2 (width is about 10 mm, thickness is about 2 mm). It is substantially flat. As will be described later, the length of the head 11 has a predetermined length (about 20 mm) necessary for grasping the head 11 with forceps (Pean forceps or the like) 20 when the sphincter device 1 advances in the body. Yes.

頭部１１は、先端から上下に盛り上がった隆起部１５を有している。この隆起部１５は、頭部１１先端の左右縁にわたって形成されており、括約筋装置１を体内で鉗子２０を用いて引っ張る際に把持しやすい形状となっている。
図２、３に示されたように、前記尾部１２は、略帯状であって、本体２の他端部２ｂから後方へ延設している。尾部１２は、本体２の後方側の連結突起１４から末端までの長さが所定長さ（約５０ｍｍ）を有している。また、尾部１２は、本体２と略同一の幅、厚みを有していて、末端の角は落として丸く形成されている。 The head 11 has a raised portion 15 that rises up and down from the tip. The raised portion 15 is formed over the left and right edges of the distal end of the head 11 and has a shape that is easy to grasp when the sphincter device 1 is pulled using the forceps 20 in the body.
As shown in FIGS. 2 and 3, the tail 12 has a substantially band shape and extends rearward from the other end 2 b of the main body 2. The tail portion 12 has a predetermined length (about 50 mm) from the connecting projection 14 on the rear side of the main body 2 to the end. The tail portion 12 has substantially the same width and thickness as the main body 2 and is rounded with the corners of the ends dropped.

第１実施形態に係る括約筋装置１の使用態様について説明する。
図４（ａ）に示したように、肛門Ｋの周囲に括約筋装置１を挿入するための穴２１ａ、２１ｂを半周ずらして２カ所（肛門Ｋの大きさによっては３分の１周ずらして３カ所）開ける。
括約筋装置１を一方の穴２１ａから埋め込む際には、他方の穴２１ｂから鉗子２０を挿入して肛門Ｋの外周を２分の１周まわし、一方の穴２１ａから鉗子２０の先端を出す。 A usage mode of the sphincter device 1 according to the first embodiment will be described.
As shown in FIG. 4 (a), the holes 21a and 21b for inserting the sphincter device 1 around the anus K are shifted by half a circle at two places (depending on the size of the anus K, the holes are shifted by a third to 3). F) Open.
When the sphincter device 1 is embedded from one hole 21a, the forceps 20 is inserted from the other hole 21b, the outer circumference of the anus K is turned by half, and the tip of the forceps 20 is taken out from the one hole 21a.

出された鉗子２０の先端で頭部１１を挟みながら、括約筋装置１を体内に引き込む。そして、他方の穴２１ｂから鉗子２０を引き出すことにつれ、括約筋装置１の頭部１１が他方の穴２１ｂから露出する。このように、括約筋装置１は、鉗子２０を使って、肛門Ｋの外周を２分の１周まわすように体内に埋め込まれる。
残り２分の１周も、同様に、一方の穴２１ａから挿入した鉗子２０で頭部１１を挟んだ状態で鉗子２０を引き抜くことで、肛門Ｋの周囲を取り囲むように体内に配置される。 The sphincter device 1 is pulled into the body while the head 11 is sandwiched between the tips of the extracted forceps 20. Then, as the forceps 20 is pulled out from the other hole 21b, the head 11 of the sphincter device 1 is exposed from the other hole 21b. In this way, the sphincter device 1 is implanted in the body using the forceps 20 so that the outer circumference of the anus K is turned by half.
Similarly, the remaining half of the circumference is arranged in the body so as to surround the periphery of the anus K by pulling out the forceps 20 with the head 11 sandwiched between the forceps 20 inserted from one hole 21a.

このとき、括約筋装置１は、所定長さを有した頭部１１及び尾部１２が一方の穴２１ａから外部に露出した状態となっている（図４（ｂ）参照）。この頭部１１及び尾部１２を掴んで引き出すことで、本体２の一端部２ａと他端部２ｂとの両方が、一方の穴２１ａから外部に露出した状態となる。この露出している一端部２ａの連結孔１３に、他端部２ｂの連結突起１４を挿入して、括約筋装置１をリング状に連結して、肛門Ｋを取り囲むように配置する。   At this time, the sphincter device 1 is in a state in which the head 11 and tail 12 having a predetermined length are exposed to the outside from one hole 21a (see FIG. 4B). By grasping and pulling out the head portion 11 and the tail portion 12, both the one end portion 2a and the other end portion 2b of the main body 2 are exposed to the outside through the one hole 21a. The connecting projection 13 of the other end 2b is inserted into the exposed connecting hole 13 of the one end 2a, and the sphincter device 1 is connected in a ring shape so as to surround the anus K.

また、患者Ｐに応じて、括約筋装置１は、肛門Ｋを取り囲む周長さＬを調整して連結される。この周長さＬは、肛門内圧測定器２３の細長いセンサ部２３ａを肛門Ｋに差し込み肛門静止圧Ｓを測りながら、２つの連結突起１４を任意の２つの連結孔１３に通して抜け止めすることで決定される。
なお、肛門静止圧Ｓとは、患者Ｐの無意識下でも内容物（便）Ｎが肛門Ｋから漏れない圧であって、肛門静止圧Ｓを適切な値とすることで、排便時以外に便Ｎが漏れることがなくなる。 Moreover, according to the patient P, the sphincter apparatus 1 is connected by adjusting the circumferential length L surrounding the anus K. This circumferential length L is obtained by inserting the elongated sensor portion 23a of the intraanal pressure measuring instrument 23 into the anus K and measuring the anal resting pressure S to prevent the two connecting protrusions 14 from passing through any two connecting holes 13. Determined by
The anal resting pressure S is a pressure at which the contents (stool) N does not leak from the anus K even under the unconsciousness of the patient P. By setting the anal resting pressure S to an appropriate value, the rest N will not leak.

この肛門静止圧Ｓが２０ｍｍＨｇ以上１２０ｍｍＨｇ以下、好ましくは、３０ｍｍＨｇ以上８０ｍｍＨｇ以下、さらに好ましくは３０ｍｍＨｇ以上５０ｍｍＨｇ以下となるように、周長さＬを調整する。また、肛門静止圧Ｓは、患者Ｐの括約筋Ｍをサポート又は代用するように、肛門Ｋを取り囲んで閉塞するように連結された本体２の弾性力（付勢力）Ｆによって生じている。   The peripheral length L is adjusted so that the anal static pressure S is 20 mmHg or more and 120 mmHg or less, preferably 30 mmHg or more and 80 mmHg or less, and more preferably 30 mmHg or more and 50 mmHg or less. The anal static pressure S is generated by the elastic force (biasing force) F of the main body 2 connected so as to surround and close the anus K so as to support or substitute for the sphincter M of the patient P.

また、本体２は、硬度２０°のシリコンゴム製であり、付勢力Ｆによって適正な肛門静止圧Ｓを保つと同時に、本体２より上流側且つ肛門Ｋ内の便Ｎを患者Ｐが腹圧で下流へ押し出した際には肛門Ｋが拡開しうる伸縮性を有している。
すなわち、この伸縮する本体２によって、括約筋装置１の付勢手段３が構成されている。 Further, the main body 2 is made of silicon rubber having a hardness of 20 °, and an appropriate anal static pressure S is maintained by the urging force F, and at the same time, the patient P has the abdominal pressure on the stool N upstream of the main body 2 and in the anus K. When pushed out downstream, the anus K has a stretchability that allows it to expand.
That is, the urging means 3 of the sphincter device 1 is constituted by the expanding and contracting main body 2.

周長さＬを調整して本体２の両端部２ａ、２ｂを連結した後で、頭部１１、尾部１２を連結手段４に支障がない範囲まで切り落とし（図１参照）、２つの穴２１ａ、２１ｂを塞ぐ。
括約筋装置１が、上述したような付勢手段３を有することで、患者Ｐは、特段の操作をしなくとも肛門Ｋの開閉ができ、排便時の煩雑さを低減できる。また、体内に残る部品が１つだけであるため、患者Ｐの侵襲を低く抑えるとともに、非常に簡単な構造であるためメンテナンスの頻度を下げ且つコストを低く抑えることができ、患者Ｐの生活の質を向上させることが可能となる。 After adjusting the circumferential length L and connecting the two end portions 2a and 2b of the main body 2, the head portion 11 and the tail portion 12 are cut off to a range that does not hinder the connecting means 4 (see FIG. 1), two holes 21a, Block 21b.
Since the sphincter device 1 has the urging means 3 as described above, the patient P can open and close the anus K without performing any special operation, and the complexity during defecation can be reduced. In addition, since only one part remains in the body, the invasion of the patient P can be kept low, and the very simple structure can reduce the frequency of maintenance and the cost, thereby reducing the life of the patient P. The quality can be improved.

したがって、本発明に係る括約筋装置１は、近年の高齢化に伴い患者Ｐが増加している括約筋Ｍの機能障害に有効である。
括約筋Ｍの機能障害は、加齢によって骨盤底筋群が脆弱となることで生じ、便Ｎの失禁をきたしたり、括約筋Ｍ機能の低下によって直腸脱の症状を併発する。これらの症状をきたした患者Ｐの肛門静止圧Ｓは多くの場合、２０ｍｍＨｇより低下しているが、括約筋装置１を用いることによって２０ｍｍＨｇ以上まで肛門静止圧Ｓを上げ、便失禁や直腸脱の症状を改善又は消失させることができる。なお、高齢者のように腹圧が弱い患者Ｐの場合には、肛門静止圧Ｓを５０ｍｍＨｇ以下とする。 Therefore, the sphincter apparatus 1 according to the present invention is effective for functional disorders of the sphincter muscle M in which the number of patients P is increasing with the recent aging.
The dysfunction of the sphincter muscle M is caused by weakening of the pelvic floor muscle group with aging, resulting in incontinence of the stool N, or the symptoms of rectal prolapse due to a decrease in the function of the sphincter muscle M. Although the anal resting pressure S of the patient P having these symptoms is often lower than 20 mmHg, the anal resting pressure S is increased to 20 mmHg or more by using the sphincter device 1, and symptoms of fecal incontinence and rectal prolapse are observed. Can be improved or eliminated. In addition, in the case of the patient P whose abdominal pressure is weak like an elderly person, the anal resting pressure S shall be 50 mmHg or less.

図５〜７には、第２実施形態に係る括約筋装置１が示されている。
第２実施形態においては、頭部１１が先細り且つ牽引糸２２で引っ張るように形成されている点と、本体２の幅が第１実施形態の約２分の１となっている点とが異なっている。
図５、６に示すように、第２実施形態の本体２及び尾部１２は、左右幅が約１０ｍｍとなっており、第１実施形態の幅（約６ｍｍ）の略半分に形成している。これによって、適正な肛門静止圧Ｓを保つと同時に、本体２より上流側且つ肛門Ｋ内の便Ｎを患者Ｐが腹圧で下流へ押し出した際には肛門Ｋが拡開しうる伸縮性を確保しながら、埋め込む際の傷口を小さくし、患者Ｐに対する侵襲を可及的に小さくすることができる。なお、本体２及び尾部１２の長さ、厚みは、第１実施形態と略同一である。 The sphincter apparatus 1 which concerns on 2nd Embodiment is shown by FIGS.
In the second embodiment, the head 11 is tapered and formed so as to be pulled by the traction thread 22, and the width of the main body 2 is about half that of the first embodiment. ing.
As shown in FIGS. 5 and 6, the main body 2 and the tail portion 12 of the second embodiment have a lateral width of about 10 mm and are formed to be approximately half the width (about 6 mm) of the first embodiment. As a result, an appropriate anal static pressure S can be maintained, and at the same time, the patient K can be stretched to expand the anus K when the patient P pushes the stool N in the anus K upstream from the body 2 by abdominal pressure. While ensuring, the wound at the time of implantation can be made small, and the invasion to the patient P can be made as small as possible. In addition, the length and thickness of the main body 2 and the tail part 12 are substantially the same as in the first embodiment.

図５、６で示す如く、頭部１１は、硬度が４０°であって、本体２の一端部２ａから前方へ延設した胴体部１１ａと、この胴体部１１ａの一端側（先端側）から延設された先端部１１ｂとを有している。頭部１１は、その延設方向（軸心方向）と本体２の長手方向とが略沿うように本体２の一端側に一体形成されている。
胴体部１１ａは、略円柱状に形成され、所定の長さ（約２５ｍｍ）、直径（約６ｍｍ）とすることで、後述するように、括約筋装置１が頭部１１を先頭として体内で進むのに必要な強度を有している。また、胴体部１１ａの基端側は、本体２の上面及び下面と略面一につながるテーパ面が設けられている。 As shown in FIGS. 5 and 6, the head 11 has a hardness of 40 °, and extends from the one end 2 a of the main body 2 to the front, and from one end (tip side) of the trunk 11 a. It has the extended front-end | tip part 11b. The head 11 is integrally formed on one end side of the main body 2 so that the extending direction (axial direction) and the longitudinal direction of the main body 2 are substantially along.
The trunk portion 11a is formed in a substantially cylindrical shape and has a predetermined length (about 25 mm) and diameter (about 6 mm), so that the sphincter device 1 advances in the body with the head 11 as the head, as will be described later. Has the necessary strength. Moreover, the base end side of the trunk | drum 11a is provided with the taper surface connected with the upper surface and lower surface of the main body 2, and a substantially flush surface.

先端部１１ｂは、胴体部１１ａの先端側に一体的に設けられた先細り状の略円錐形であって、その頂角は約６０°で高さは約５ｍｍである。
前記胴体部１１ａの周面に周溝１１ｃが設けられている。この周溝１１ｃは、先端部１１ｂの基端側から所定距離（約５ｍｍ）離れた後方に胴体部１１ａの周方向に沿って形成されている。この周溝１１ｃから先端部１１ｂの途中までにわたる頭部１１の左右側部には、頭部１１の長さ方向に延びる縦溝１１ｄがそれぞれ設けられている。 The distal end portion 11b is a tapered substantially conical shape integrally provided on the distal end side of the body portion 11a. The apex angle is about 60 ° and the height is about 5 mm.
A circumferential groove 11c is provided on the circumferential surface of the body portion 11a. The circumferential groove 11c is formed along the circumferential direction of the body portion 11a on the rear side at a predetermined distance (about 5 mm) from the proximal end side of the distal end portion 11b. Longitudinal grooves 11d extending in the length direction of the head 11 are provided on the left and right sides of the head 11 extending from the circumferential groove 11c to the middle of the tip 11b.

この縦溝１１ｄは、その底面が前記周溝１１ｃの底面と略面一状に連通している。
なお、周溝１１ｃ及び縦溝１１ｄは、後述の牽引糸２２を巻き付けたり、嵌め込んだりできるような所定の深さ（約１ｍｍ）及び幅（約１ｍｍ）に設定されている。
第２実施形態に係る括約筋装置１の使用態様について説明する。
第２実施形態の使用形態において、第１実施形態で用いる鉗子２０よりも細い鉗子を用いる点とが異なっている。 The bottom surface of the vertical groove 11d communicates with the bottom surface of the circumferential groove 11c in a substantially flush manner.
In addition, the circumferential groove 11c and the vertical groove 11d are set to a predetermined depth (about 1 mm) and width (about 1 mm) so that a pulling thread 22 described later can be wound or fitted.
A usage mode of the sphincter device 1 according to the second embodiment will be described.
The use form of the second embodiment is different from the use of forceps thinner than the forceps 20 used in the first embodiment.

図７（ａ）に示したように、肛門Ｋに周囲に穴２１ａ、２１ｂを開け、一方の穴２１ａから頭部１１を挿入し、括約筋装置１が肛門Ｋの括約筋Ｍ外周をまわって他方の穴２１ｂから頭部１１を出せるように、体内で引っ張るための牽引糸２２を頭部１１に取り付ける。
頭部１１の周溝１１ｃに牽引糸２２を巻き付け、この牽引糸２２の余った両方の端部２２Ａを左右の縦溝１１ｄに沿わせながら頭部１１前方に持ってくる。この両端部２２Ａを細い鉗子（図示省略）の先端に巻き付けて、この細い鉗子を使って先に両端部２２Ａを一方の穴２１ａから他方の穴２１ｂに通す。 As shown in FIG. 7 (a), holes 21a and 21b are opened around the anus K, the head 11 is inserted through one hole 21a, and the sphincter device 1 rotates around the outer periphery of the sphincter M of the anus K. A pulling thread 22 for pulling inside the body is attached to the head 11 so that the head 11 can be taken out from the hole 21b.
The traction thread 22 is wound around the circumferential groove 11c of the head 11 and both ends 22A of the traction thread 22 are brought forward in front of the head 11 along the left and right vertical grooves 11d. The two end portions 22A are wound around the tip of a thin forceps (not shown), and the two end portions 22A are first passed from one hole 21a to the other hole 21b using the thin forceps.

他方の穴２１ｂから出した牽引糸２２の両端部２２Ａを引っ張ることによって、括約筋装置１が括約筋Ｍの周りを半周まわって肛門Ｋを周辺に配置される。
さらに、牽引糸２２の両端部２２Ａを他方の穴２１ｂから一方の穴２１ａに通した後に、括約筋Ｍの残り外周半分を巡らすことで、括約筋装置１は、頭部１１及び尾部１２が一方の穴２１ａから外部に露出する（図７（ｂ）参照）。 By pulling both ends 22A of the pulling thread 22 from the other hole 21b, the sphincter device 1 is placed around the sphincter M and placed around the anus K around the sphincter M.
Further, after passing the two end portions 22A of the pulling thread 22 from the other hole 21b to the one hole 21a, the sphincter device 1 has the head 11 and the tail portion 12 in one hole through the remaining outer half of the sphincter M. 21a is exposed to the outside (see FIG. 7B).

このように、牽引糸２２を細い鉗子で引っ張って、括約筋装置１を肛門Ｋ周辺に配置することで、埋め込み時に使用する道具の小型化が図られ、さらなる侵襲の抑制が実現できる。
その他の括約筋装置１の構成、作用効果及び使用態様は、第１実施形態と同様である。
本発明は、前述した実施形態に限定されるものではない。括約筋装置１等の各構成又は全体の構造、形状、寸法などは、本発明の趣旨に沿って適宜変更することができる。 In this way, by pulling the traction thread 22 with thin forceps and placing the sphincter device 1 around the anus K, the tool used at the time of implantation can be reduced in size, and further suppression of invasion can be realized.
Other configurations, functions and effects of the sphincter device 1 are the same as those in the first embodiment.
The present invention is not limited to the embodiment described above. Each configuration of the sphincter device 1 or the like, or the overall structure, shape, dimensions, and the like can be appropriately changed in accordance with the spirit of the present invention.

括約筋装置１は、肛門Ｋに用いるだけでなく、尿道に用いてもよく、この場合、腹圧性尿失禁等を起こした患者Ｐに対して尿道を取り囲むように体内へ挿入する。また、この場合、内容物Ｎは尿となる。
括約筋装置１は、本体２を、拒絶反応が起きにくいチタン、銅合金などの金属で形成した略円弧状に湾曲した複数の棒状部材で構成し、各棒状部材をつなぐシリコンゴム等の伸縮自在な繋ぎ部材を付勢手段３としてもよい。 The sphincter device 1 may be used not only for the anus K but also for the urethra. In this case, the sphincter device 1 is inserted into the body so as to surround the urethra for a patient P who has experienced stress urinary incontinence. In this case, the content N is urine.
The sphincter device 1 is composed of a plurality of rod-like members curved in a substantially arc shape formed of a metal such as titanium, copper alloy, etc., in which rejection reaction is unlikely to occur, and a stretchable material such as silicon rubber that connects the rod-like members. The connecting member may be the urging means 3.

また、括約筋装置１は、本体２が器官の管部Ｋを洗濯バサミ状に挟む一対の把持部材であってもよく、その把持部材を巻バネ、板バネなどの付勢手段３によって管部Ｋを挟む方向に付勢してもよい。この場合、把持部材、付勢手段３はチタン、銅合金などの金属製とする。
さらに、括約筋装置１は、シリコンゴムで形成しなくてもよく、ポリオレフィン繊維などの他の生体適合材料によって形成してもよい。 Further, the sphincter device 1 may be a pair of gripping members in which the main body 2 sandwiches the organ tube portion K in the shape of a clothespin, and the gripping member is connected to the tube portion K by a biasing means 3 such as a winding spring or a leaf spring. You may bias in the direction which pinches | interposes. In this case, the holding member and the biasing means 3 are made of metal such as titanium or copper alloy.
Furthermore, the sphincter device 1 may not be formed of silicon rubber, but may be formed of other biocompatible materials such as polyolefin fibers.

括約筋装置１をシリコンゴムで形成した場合、本体２によって、適正な肛門静止圧Ｓを保つとともに、患者Ｐが腹圧で便Ｎを下流へ押し出したときに肛門Ｋが拡開可能であるならば、その硬度は、２０°や４０°でなくてもよく、約１０°以上約６０°以下であってもよい。
括約筋装置１は、頭部１１や尾部１２を有していなくてもよい。 If the sphincter device 1 is formed of silicone rubber, the body 2 maintains an appropriate anal static pressure S, and the anus K can be expanded when the patient P pushes the stool N downstream with abdominal pressure. The hardness may not be 20 ° or 40 °, but may be about 10 ° or more and about 60 ° or less.
The sphincter device 1 may not have the head portion 11 and the tail portion 12.

括約筋装置１の硬度は、部分的に変えてもよく、本体２の長手方向における中途部分の硬度を両端部２ａ、２ｂより下げたものや、頭部１１、連結孔１３、連結突起１４等の硬度を他の部位より上げたものとしてもよい、
本体２の左右幅は、約６ｍｍや約１０ｍｍでなくともよく、約４ｍｍ以上約１８ｍｍ以下、好ましくは約６ｍｍ以上約１６ｍｍ以下、さらに好ましくは約８ｍｍ以上約１２ｍｍ以下であってもよい。 The hardness of the sphincter device 1 may be partially changed, such as the one in which the hardness of the midway portion in the longitudinal direction of the main body 2 is lowered from both end portions 2a, 2b, the head 11, the connecting hole 13, the connecting protrusion 14, etc. It is good also as what raised hardness from other parts.
The left-right width of the main body 2 may not be about 6 mm or about 10 mm, but may be about 4 mm or more and about 18 mm or less, preferably about 6 mm or more and about 16 mm or less, more preferably about 8 mm or more and about 12 mm or less.

連結手段４は、連結孔１３を連結突起１４に挿通させて抜け止めするものでなく、両端部２ａ、２ｂを接着、融解したり、チタン等で形成したハトメ、カシメ、ステープラーなどの固定具や、糸、紐によって止めるものとしてもよい。
頭部１１は、略平板状や略円錐状でなく、鉗子２０で掴みやすいように頭部１１に孔を開けたリング状であってもよい。 The connecting means 4 does not prevent the connecting hole 13 from being inserted through the connecting protrusion 14 but also attaches and melts both end portions 2a and 2b, or a fixing tool such as eyelet, caulking or stapler formed of titanium or the like. It is good also as what stops with a thread | yarn and a string.
The head 11 may not be substantially flat or conical, but may be a ring having a hole in the head 11 so that the head 11 can be easily grasped.

連結孔１３は、５つでなくともよく、最低でも連結突起１４の数よりも１以上多く、１０個以下であってもよい。連結孔１３の直径は、約１ｍｍでなくても、約０．５ｍｍ以上約２ｍｍ以下であってもよい。
連結突起１４は、連結孔１３に嵌入可能であるならば、突起胴部１４ａの直径が約２ｍｍでなくとも、約２ｍｍ以上約６ｍｍ以下であればよく、突起頭部１４ｂの直径が約４ｍｍでなくとも、約４ｍｍ以上約１２ｍｍ以下であればよい。 The number of connecting holes 13 is not limited to five, and may be at least 1 and 10 or less than the number of connecting protrusions 14 at the minimum. The diameter of the connection hole 13 may not be about 1 mm, but may be about 0.5 mm or more and about 2 mm or less.
As long as the connecting protrusion 14 can be fitted into the connecting hole 13, the diameter of the protrusion body 14 a may be about 2 mm to about 6 mm, and the diameter of the protrusion head 14 b is about 4 mm, even if the diameter is not about 2 mm. Even if it is not, it should just be about 4 mm or more and about 12 mm or less.

１ 括約筋装置
２ 本体
２ａ 本体の一端部
２ｂ 本体の他端部
３ 付勢手段
４ 連結手段
Ｋ 器官の管部（肛門）
Ｎ 内容物
Ｆ 付勢力
Ｌ 囲い長さ
Ｓ 肛門静止圧 DESCRIPTION OF SYMBOLS 1 Sphincter apparatus 2 Main body 2a One end part of a main body 2b The other end part of a main body 3 Energizing means 4 Connecting means K Organ pipe part (anus)
N Contents F Energizing force L Enclosure length S Anal static pressure

本発明は、肛門、尿道などの器官の管部周囲に配置された括約筋装置に関するものである。   The present invention relates to a sphincter device disposed around a tube portion of an organ such as an anus or urethra.

従来、器官の管部のために人体に埋没可能な人工括約筋装置が知られている。
この人工括約筋装置は、管部の周りに配置されるようになっており、膨張時に管部の周りに閉じ且つ管部を閉鎖し、且つ収縮時に管部を開く膨張可能な可撓性カフと、カフの周りに配置され且つカフに締着され、且つ膨張時管部から外方へ真直ぐにされ且つ開くように処置された膨張可能な可撓性リザバーリングと、カフ及びリングを相互連結する流体通路と、流体をカフからリザバーリングへ移送する装置とを備えている（特許文献１参照）。 2. Description of the Related Art Conventionally, an artificial sphincter device that can be buried in a human body for an organ tube is known.
The artificial sphincter device is adapted to be placed around a tube portion, an inflatable flexible cuff that closes and closes the tube portion when inflated and opens the tube portion when contracted. Interconnecting the cuff and the ring with an inflatable flexible reservoir ring disposed about the cuff and fastened to the cuff and straightened outwardly from the tube when inflated and treated to open A fluid passage and a device for transferring fluid from the cuff to the reservoir ring are provided (see Patent Document 1).

特公平６−３８８０８号公報Japanese Examined Patent Publication No. 6-38808

上記従来の人工括約筋装置は、管部を開閉させるためには、その都度ポンプや加熱回路を切換操作しなくてはならない構造であって、排泄時の操作性が悪い。
また、管部を開閉するカフ以外に、上述のポンプ及び加熱回路や、リザバーリング、３つの流体伝達ライン、運動制御リング及びコイルなどの多くの部材を体内の複数箇所に埋め込む必要があり、人体に大きな侵襲を負わせる。 The conventional artificial sphincter device has a structure in which the pump and the heating circuit must be switched each time to open and close the tube portion, and the operability during excretion is poor.
In addition to the cuff that opens and closes the pipe, it is necessary to embed many members such as the pump and heating circuit, the reservoir ring, the three fluid transmission lines, the motion control ring, and the coil at multiple locations in the body. Can be very invasive.

さらに、人工括約筋装置から体内に流体が漏れたり、電気回路が故障するなどの虞や、構造が複雑なためにメンテナンスの困難性やコスト高などの問題もある。
本発明は、このような問題点に鑑みて、器官の管部を取り囲む本体より上流側で且つ管部内の内容物を腹圧で下流へ押圧することによって拡開可能に管部を閉塞する付勢手段を有することで、管部を開閉する切換操作を必要とせず、部品点数の減少及び構造の簡素化を実現して、人体にかかる侵襲を低く抑え、メンテナンス性及び経済性を上げ、括約筋機能が低下した患者の生活の質を向上させる括約筋装置を提供することを目的とする。 In addition, there is a risk of fluid leaking from the artificial sphincter device into the body or failure of an electric circuit, and problems such as difficulty in maintenance and high costs due to the complicated structure.
In view of such a problem, the present invention attaches the tube portion so that the tube portion can be expanded by pressing the contents in the tube portion downstream from the main body surrounding the tube portion of the organ and the abdominal pressure. By having a biasing means, switching operation to open and close the pipe part is not required, reducing the number of parts and simplifying the structure, keeping the invasion on the human body low, improving maintenance and economy, and sphincter The object is to provide a sphincter device that improves the quality of life of patients with reduced function.

前記課題を達成するために、本発明は、以下の技術的手段を採用した。
器官の管部Ｋを取り囲んで閉塞した長尺のシリコンゴム製の本体２によって、この本体２より上流側且つ前記管部Ｋ内の内容物Ｎを腹圧で下流へ押圧した際に前記管部Ｋが拡開可能な付勢力Ｆで前記管部Ｋを閉塞方向に付勢させ、
前記本体２の一端部２ａに連結孔１３が穿孔され、他端部２ｂに前記連結孔１３へ挿通する連結突起１４が本体２と一体的に立設され、
前記連結突起１４は、前記連結孔１３より大径な突起胴部１４ａと、この突起胴部１４ａより大径で且つ前記本体２による付勢中に挿通した連結孔１３からの抜けを止める突起頭部１４ｂとを有している。 In order to achieve the above object, the present invention employs the following technical means.
When the long silicone rubber main body 2 surrounding and closing the tube portion K of the organ is pressed upstream of the main body 2 and the content N in the tube portion K downstream by abdominal pressure, the tube portion The tube portion K is urged in the closing direction with an urging force F that allows K to expand,
A connecting hole 13 is drilled in one end 2a of the main body 2, and a connecting protrusion 14 is inserted into the connecting hole 13 in the other end 2b.
The connection protrusion 14 has a protrusion body portion 14a having a diameter larger than that of the connection hole 13, and a protrusion head that has a diameter larger than that of the protrusion body portion 14a and prevents the connection hole 13 from being pulled out during urging by the main body 2. Part 14b.

また、前記管部Ｋは、肛門Ｋであって、The tube K is an anus K,
この肛門Ｋを取り囲んだ本体２によって肛門静止圧Ｓが２０ｍｍＨｇ以上１２０ｍｍＨｇ以下となる前記付勢力Ｆ下で前記連通孔１３へ連結突起１４を挿通すべく、前記本体２に一端縁から所定間隔ごとに複数穿孔された略円形の前記連結孔１３より少数の前記連結突起１４を、前記他端部２ｂの前記所定間隔ごとに断面略円形状に複数立設している。The main body 2 surrounding the anus K is inserted into the main body 2 at a predetermined interval from one end edge so that the connecting protrusion 14 is inserted into the communication hole 13 under the urging force F at which the anal static pressure S is 20 mmHg or more and 120 mmHg or less. A plurality of the connection protrusions 14 are erected in a substantially circular cross section at each predetermined interval of the other end 2b than the plurality of substantially circular connection holes 13 perforated.

なお、前記管部Ｋは、尿道であってもよい。
そして、本発明は、次の特徴を有する。
第１に、器官の管部Ｋを取り囲んで閉塞した本体２と、この本体２より上流側且つ前記管部Ｋ内の内容物Ｎを腹圧で下流へ押圧した際に前記管部Ｋが拡開可能な付勢力Ｆで前記管部Ｋを閉塞方向に付勢した付勢手段３とを有していることを特徴とする。 The tube portion K may be a urethra.
And this invention has the following characteristics.
First, the main body 2 surrounding and closing the tube portion K of the organ, and the tube portion K expands when the contents N in the tube portion K upstream of the main body 2 are pressed downstream by abdominal pressure. And an urging means 3 that urges the tube portion K in the closing direction with an urging force F that can be opened.

第２に、前記管部Ｋは、肛門Ｋであって、
前記付勢手段３を、長尺のシリコンゴムで形成された前記本体２によって構成し、
前記本体２は、前記肛門Ｋを取り囲んだ時に一端部２ａと他端部２ｂとを連結する連結手段４を囲い長さＬ調整自在に備えていることを特徴とする。
第３に、前記付勢力Ｆを、前記本体２で肛門Ｋを取り囲んだ時の肛門静止圧Ｓが２０ｍｍＨｇ以上１２０ｍｍＨｇ以下となるように設定していることを特徴とする。 Second, the tube K is an anus K,
The urging means 3 is constituted by the main body 2 formed of a long silicon rubber,
The main body 2 includes a connecting means 4 for connecting the one end portion 2a and the other end portion 2b when the anus K is surrounded, so that the length L is adjustable.
Thirdly, the urging force F is set so that an anal static pressure S when the body 2 surrounds the anus K is 20 mmHg or more and 120 mmHg or less.

これらの特徴により、管部Ｋを取り囲む本体２と、管部Ｋ内の内容物Ｎを腹圧で下流へ押圧した際に拡開可能な付勢力Ｆで管部Ｋを閉塞する付勢手段３とを有することで、特段の操作なしに管部Ｋの開閉が可能となり、使用者Ｐの煩雑さを低減できる。そして、必要な部品点数を減らして人体への負担を抑えるとともに、簡単な構造となるためメンテナンスの必要がほとんどなく且つコストを低く抑えることができ、使用者Ｐの生活の質を向上させる。   Due to these characteristics, the main body 2 surrounding the pipe part K and the urging means 3 for closing the pipe part K with an urging force F that can be expanded when the contents N in the pipe part K are pressed downstream by abdominal pressure. The tube portion K can be opened and closed without any special operation, and the complexity of the user P can be reduced. And while reducing the number of necessary parts and reducing the burden on the human body, since it has a simple structure, there is almost no need for maintenance and the cost can be kept low, and the quality of life of the user P is improved.

また、付勢手段３を、長尺のシリコンゴムで形成された本体２で付勢手段３を構成することで、さらなる部品点数の減少及び管部Ｋである肛門Ｋ周囲への埋め込みの容易化を図り、肛門Ｋを取り囲んだ状態で本体２の一端部２ａと他端部２ｂとを連結する連結手段４を囲い長さＬ調整自在に備えることで、肛門Ｋを閉塞する付勢力Ｆを使用者Ｐに応じて調整することができる。   Further, the urging means 3 is constituted by the main body 2 formed of a long silicon rubber, thereby further reducing the number of parts and facilitating implantation around the anus K that is the tube portion K. The urging force F that closes the anus K is used by providing the connecting means 4 that connects the one end 2a and the other end 2b of the main body 2 with the length L adjustable while surrounding the anus K. Can be adjusted according to the person P.

さらに、本体２で肛門Ｋを取り囲んだ時の肛門静止圧Ｓが２０ｍｍＨｇ以上１２０ｍｍＨｇ以下となるように付勢力Ｆを設定することで、内容物Ｎの漏れを防止すると同時に、適度な腹圧で容易に肛門Ｋを拡開できるようになる。   Furthermore, by setting the urging force F so that the anal static pressure S when the anus K is surrounded by the main body 2 is 20 mmHg or more and 120 mmHg or less, leakage of the contents N is prevented and at the same time easy with moderate abdominal pressure The anus K can be expanded.

本発明に係る括約筋装置によると、管部を取り囲んだ本体と、管部内の内容物を腹圧で下流へ押圧した際に管部が拡開可能な付勢力で管部を閉塞付勢した付勢手段とを有することで、管部の開閉に伴う煩雑な切換操作をなくし、部品点数の減少によって侵襲を抑え、構造の簡素化によってメンテナンス性及び経済性の向上を図ることができる。   According to the sphincter apparatus according to the present invention, the main body that surrounds the pipe section and the biasing force that closes and biases the pipe section with a biasing force that allows the pipe section to expand when the contents in the pipe section are pressed downstream by abdominal pressure. By having the biasing means, it is possible to eliminate a complicated switching operation associated with the opening and closing of the pipe part, to suppress the invasion by reducing the number of parts, and to improve the maintainability and economy by simplifying the structure.

第１実施形態に係る括約筋装置を体内に埋め込んだ際の斜視図である。It is a perspective view at the time of embedding the sphincter apparatus which concerns on 1st Embodiment in a body. 括約筋装置の平面図である。It is a top view of a sphincter device. 括約筋装置の側面図である。It is a side view of a sphincter device. 括約筋装置の使用態様を示す概要図である。It is a schematic diagram which shows the usage condition of a sphincter device. 第２実施形態に係る括約筋装置の平面図である。It is a top view of the sphincter device concerning a 2nd embodiment. 括約筋装置の側面図である。It is a side view of a sphincter device. 括約筋装置の使用態様を示す概要図である。It is a schematic diagram which shows the usage condition of a sphincter device.

以下、本発明の実施の形態を図面を参照して説明する。
図１〜４には、本発明の第１実施形態に係る括約筋装置１が示されている。
この括約筋装置１は、略紐状でのシリコンゴムであって、使用者（患者）Ｐの肛門Ｋを取り囲むように体内に埋め込まれ、長手方向に伸縮自在に形成されている。
括約筋装置１は、長尺の本体２と、この本体２の一端部２ａ及び他端部２ｂを連結する連結手段４と、本体２の一端部２ａに設けられた頭部１１と、本体２の他端部２ｂに設けられた尾部１２とを一体として形成している。 Hereinafter, embodiments of the present invention will be described with reference to the drawings.
1-4 show a sphincter device 1 according to a first embodiment of the present invention.
This sphincter device 1 is a substantially string-like silicone rubber, is embedded in the body so as to surround an anus K of a user (patient) P, and is formed to be stretchable in the longitudinal direction.
The sphincter device 1 includes a long main body 2, connecting means 4 for connecting one end 2 a and the other end 2 b of the main body 2, a head 11 provided at one end 2 a of the main body 2, The tail part 12 provided in the other end part 2b is integrally formed.

なお、括約筋装置１の硬度は、頭部１１及び後述の連結突起１４は硬度４０°であり、これら以外の部分は硬度２０°となっている。また、本発明における硬度の単位は、「ＪＩＳ Ｋ ６２５３」や「ＩＳＯ４８」、「ＩＳＯ７６１９」に準拠している。
図２、３に示すように、本体２は、肛門Ｋを取り囲みうる所定長さ（本実施形態では約８５ｍｍ）を有した略帯状であって、所定の左右幅（約１０ｍｍ）、厚み（約２ｍｍ）とすることで、本体２の伸縮性を十分に確保できる。また、本体２は、一端部２ａ側に複数穿設された連結孔１３（本実施形態では５つ）と、他端部２ｂ側に複数突設された連結突起１４（本実施形態では２つ）とを有している。 The sphincter device 1 has a hardness of 40 ° at the head 11 and a connecting projection 14 described later, and a hardness of 20 ° at other portions. The unit of hardness in the present invention is in conformity with “JIS K 6253”, “ISO48”, and “ISO7619”.
As shown in FIGS. 2 and 3, the main body 2 has a substantially band shape having a predetermined length (about 85 mm in the present embodiment) that can surround the anus K, and has a predetermined left-right width (about 10 mm) and thickness (about about 2 mm), the stretchability of the main body 2 can be sufficiently secured. The main body 2 includes a plurality of connecting holes 13 (five in this embodiment) drilled on one end 2a side and a plurality of connecting projections 14 (two in this embodiment) projecting on the other end 2b side. ).

連結孔１３は、後述する連結突起１４の突起胴部１４ａよりも小さい直径（約１ｍｍ）であって、本体２の一端縁から所定間隔（約５ｍｍ）ごと複数箇所に穿孔されている。
連結突起１４は、本体２の上面から立設した突起胴部１４ａと、この突起胴部１４ａの上端に設けられたフランジ状の突起頭部１４ｂとを有している。突起胴部１４ａは、略円柱状であって、直径は前記連結孔１３よりも大径（約２ｍｍ）で、高さが本体２の厚みと略同じ（約２ｍｍ）である。突起頭部１４ｂは、突起胴部１４ａよりも大径（約４ｍｍ）の略円盤状であって、後述するように連結突起１４を連結孔１３に通した際、突起頭部１４ｂ自体が弾性変形して抜けないような所定の厚さ（約１ｍｍ）を有している。 The connection hole 13 has a diameter (about 1 mm) smaller than a protrusion body portion 14a of the connection protrusion 14 to be described later, and is drilled at a plurality of locations at predetermined intervals (about 5 mm) from one end edge of the main body 2.
The connection protrusion 14 has a protrusion body portion 14 a erected from the upper surface of the main body 2 and a flange-shaped protrusion head portion 14 b provided at the upper end of the protrusion body portion 14 a. The protrusion body portion 14a has a substantially cylindrical shape, and has a diameter larger than that of the connection hole 13 (about 2 mm) and a height substantially the same as the thickness of the main body 2 (about 2 mm). The protruding head 14b has a substantially disk shape with a larger diameter (about 4 mm) than the protruding body 14a. When the connecting protrusion 14 is passed through the connecting hole 13 as will be described later, the protruding head 14b itself is elastically deformed. And has a predetermined thickness (about 1 mm) so as not to come off.

連結突起１４は、シリコンゴムで本体２と一体的に形成されており、連結孔１３は径方向に、連結突起１４は径方向及び軸心方向に伸び縮み自在である。
つまり、連結突起１４は、連結孔１３を拡開して本体２の下面から入れ込み、突起頭部１４ｂを本体２上面側に出すことができ、これによって、連結突起１４の連結孔１３に対する抜け止めがなされる。 The connection protrusion 14 is formed integrally with the main body 2 with silicon rubber, and the connection hole 13 can expand and contract in the radial direction, and the connection protrusion 14 can expand and contract in the radial direction and the axial direction.
That is, the connecting projection 14 can be inserted from the lower surface of the main body 2 by expanding the connecting hole 13, and the protruding head 14 b can be brought out to the upper surface side of the main body 2, thereby preventing the connecting projection 14 from coming off from the connecting hole 13. Is made.

また、２つの連結突起１４を５つ中２つの連結孔１３に挿入することで、本体２で肛門Ｋを取り囲んだ状態で本体２の一端部２ａと他端部２ｂとがリング状に連結される。
つまり、連結孔１３と連結突起１４とで連結手段４を構成している。
また、本体２が２カ所で抜け止めされるため、両端部２ａ、２ｂ連結時の本体２の向き決め（一端部２ａにおける長手方向と、他端部２ｂにおける長手方向とを略揃えること）が可能となる。 Further, by inserting the two connecting projections 14 into the two connecting holes 13 out of the five, the one end 2a and the other end 2b of the main body 2 are connected in a ring shape with the main body 2 surrounding the anus K. The
That is, the connection means 4 is constituted by the connection hole 13 and the connection protrusion 14.
Further, since the main body 2 is prevented from coming off at two locations, the orientation of the main body 2 when the both end portions 2a and 2b are connected (the longitudinal direction at the one end portion 2a and the longitudinal direction at the other end portion 2b are substantially aligned). It becomes possible.

さらに、連結突起１４を挿入する連結孔１３を５つの内から２つ選択可能であるため、本体２は、連結手段４によって肛門Ｋの取り囲む長さ（周長さ）Ｌを調整自在に構成されている。
図２、３に示す如く、頭部１１は、本体２の一端部２ａから前方に延設していて、幅及び厚みが前記本体２と略同一（幅が約１０ｍｍ、厚みが略２ｍｍ）の略平板状である。頭部１１の長さは、後述するように、括約筋装置１が体内で進む際に頭部１１を鉗子（ペアン鉗子等）２０で掴むのに必要な所定長さ（約２０ｍｍ）を有している。 Furthermore, since two connection holes 13 for inserting the connection protrusions 14 can be selected from among the five, the main body 2 is configured such that the length (circumferential length) L surrounding the anus K can be adjusted by the connection means 4. ing.
As shown in FIGS. 2 and 3, the head 11 extends forward from one end 2 a of the main body 2, and has the same width and thickness as the main body 2 (width is about 10 mm, thickness is about 2 mm). It is substantially flat. As will be described later, the length of the head 11 has a predetermined length (about 20 mm) necessary for grasping the head 11 with forceps (Pean forceps or the like) 20 when the sphincter device 1 advances in the body. Yes.

頭部１１は、先端から上下に盛り上がった隆起部１５を有している。この隆起部１５は、頭部１１先端の左右縁にわたって形成されており、括約筋装置１を体内で鉗子２０を用いて引っ張る際に把持しやすい形状となっている。
図２、３に示されたように、前記尾部１２は、略帯状であって、本体２の他端部２ｂから後方へ延設している。尾部１２は、本体２の後方側の連結突起１４から末端までの長さが所定長さ（約５０ｍｍ）を有している。また、尾部１２は、本体２と略同一の幅、厚みを有していて、末端の角は落として丸く形成されている。 The head 11 has a raised portion 15 that rises up and down from the tip. The raised portion 15 is formed over the left and right edges of the distal end of the head 11 and has a shape that is easy to grasp when the sphincter device 1 is pulled using the forceps 20 in the body.
As shown in FIGS. 2 and 3, the tail 12 has a substantially band shape and extends rearward from the other end 2 b of the main body 2. The tail portion 12 has a predetermined length (about 50 mm) from the connecting projection 14 on the rear side of the main body 2 to the end. The tail portion 12 has substantially the same width and thickness as the main body 2 and is rounded with the corners of the ends dropped.

第１実施形態に係る括約筋装置１の使用態様について説明する。
図４（ａ）に示したように、肛門Ｋの周囲に括約筋装置１を挿入するための穴２１ａ、２１ｂを半周ずらして２カ所（肛門Ｋの大きさによっては３分の１周ずらして３カ所）開ける。
括約筋装置１を一方の穴２１ａから埋め込む際には、他方の穴２１ｂから鉗子２０を挿入して肛門Ｋの外周を２分の１周まわし、一方の穴２１ａから鉗子２０の先端を出す。 A usage mode of the sphincter device 1 according to the first embodiment will be described.
As shown in FIG. 4 (a), the holes 21a and 21b for inserting the sphincter device 1 around the anus K are shifted by half a circle at two places (depending on the size of the anus K, the holes are shifted by a third to 3). F) Open.
When the sphincter device 1 is embedded from one hole 21a, the forceps 20 is inserted from the other hole 21b, the outer circumference of the anus K is turned by half, and the tip of the forceps 20 is taken out from the one hole 21a.

出された鉗子２０の先端で頭部１１を挟みながら、括約筋装置１を体内に引き込む。そして、他方の穴２１ｂから鉗子２０を引き出すことにつれ、括約筋装置１の頭部１１が他方の穴２１ｂから露出する。このように、括約筋装置１は、鉗子２０を使って、肛門Ｋの外周を２分の１周まわすように体内に埋め込まれる。
残り２分の１周も、同様に、一方の穴２１ａから挿入した鉗子２０で頭部１１を挟んだ状態で鉗子２０を引き抜くことで、肛門Ｋの周囲を取り囲むように体内に配置される。 The sphincter device 1 is pulled into the body while the head 11 is sandwiched between the tips of the extracted forceps 20. Then, as the forceps 20 is pulled out from the other hole 21b, the head 11 of the sphincter device 1 is exposed from the other hole 21b. In this way, the sphincter device 1 is implanted in the body using the forceps 20 so that the outer circumference of the anus K is turned by half.
Similarly, the remaining half of the circumference is arranged in the body so as to surround the periphery of the anus K by pulling out the forceps 20 with the head 11 sandwiched between the forceps 20 inserted from one hole 21a.

このとき、括約筋装置１は、所定長さを有した頭部１１及び尾部１２が一方の穴２１ａから外部に露出した状態となっている（図４（ｂ）参照）。この頭部１１及び尾部１２を掴んで引き出すことで、本体２の一端部２ａと他端部２ｂとの両方が、一方の穴２１ａから外部に露出した状態となる。この露出している一端部２ａの連結孔１３に、他端部２ｂの連結突起１４を挿入して、括約筋装置１をリング状に連結して、肛門Ｋを取り囲むように配置する。   At this time, the sphincter device 1 is in a state in which the head 11 and tail 12 having a predetermined length are exposed to the outside from one hole 21a (see FIG. 4B). By grasping and pulling out the head portion 11 and the tail portion 12, both the one end portion 2a and the other end portion 2b of the main body 2 are exposed to the outside through the one hole 21a. The connecting projection 13 of the other end 2b is inserted into the exposed connecting hole 13 of the one end 2a, and the sphincter device 1 is connected in a ring shape so as to surround the anus K.

また、患者Ｐに応じて、括約筋装置１は、肛門Ｋを取り囲む周長さＬを調整して連結される。この周長さＬは、肛門内圧測定器２３の細長いセンサ部２３ａを肛門Ｋに差し込み肛門静止圧Ｓを測りながら、２つの連結突起１４を任意の２つの連結孔１３に通して抜け止めすることで決定される。
なお、肛門静止圧Ｓとは、患者Ｐの無意識下でも内容物（便）Ｎが肛門Ｋから漏れない圧であって、肛門静止圧Ｓを適切な値とすることで、排便時以外に便Ｎが漏れることがなくなる。 Moreover, according to the patient P, the sphincter apparatus 1 is connected by adjusting the circumferential length L surrounding the anus K. This circumferential length L is obtained by inserting the elongated sensor portion 23a of the intraanal pressure measuring instrument 23 into the anus K and measuring the anal resting pressure S to prevent the two connecting protrusions 14 from passing through any two connecting holes 13. Determined by
The anal resting pressure S is a pressure at which the contents (stool) N does not leak from the anus K even under the unconsciousness of the patient P. By setting the anal resting pressure S to an appropriate value, the rest N will not leak.

この肛門静止圧Ｓが２０ｍｍＨｇ以上１２０ｍｍＨｇ以下、好ましくは、３０ｍｍＨｇ以上８０ｍｍＨｇ以下、さらに好ましくは３０ｍｍＨｇ以上５０ｍｍＨｇ以下となるように、周長さＬを調整する。また、肛門静止圧Ｓは、患者Ｐの括約筋Ｍをサポート又は代用するように、肛門Ｋを取り囲んで閉塞するように連結された本体２の弾性力（付勢力）Ｆによって生じている。   The peripheral length L is adjusted so that the anal static pressure S is 20 mmHg or more and 120 mmHg or less, preferably 30 mmHg or more and 80 mmHg or less, and more preferably 30 mmHg or more and 50 mmHg or less. The anal static pressure S is generated by the elastic force (biasing force) F of the main body 2 connected so as to surround and close the anus K so as to support or substitute for the sphincter M of the patient P.

また、本体２は、硬度２０°のシリコンゴム製であり、付勢力Ｆによって適正な肛門静止圧Ｓを保つと同時に、本体２より上流側且つ肛門Ｋ内の便Ｎを患者Ｐが腹圧で下流へ押し出した際には肛門Ｋが拡開しうる伸縮性を有している。
すなわち、この伸縮する本体２によって、括約筋装置１の付勢手段３が構成されている。 Further, the main body 2 is made of silicon rubber having a hardness of 20 °, and an appropriate anal static pressure S is maintained by the urging force F, and at the same time, the patient P has the abdominal pressure on the stool N upstream of the main body 2 and in the anus K. When pushed out downstream, the anus K has a stretchability that allows it to expand.
That is, the urging means 3 of the sphincter device 1 is constituted by the expanding and contracting main body 2.

周長さＬを調整して本体２の両端部２ａ、２ｂを連結した後で、頭部１１、尾部１２を連結手段４に支障がない範囲まで切り落とし（図１参照）、２つの穴２１ａ、２１ｂを塞ぐ。
括約筋装置１が、上述したような付勢手段３を有することで、患者Ｐは、特段の操作をしなくとも肛門Ｋの開閉ができ、排便時の煩雑さを低減できる。また、体内に残る部品が１つだけであるため、患者Ｐの侵襲を低く抑えるとともに、非常に簡単な構造であるためメンテナンスの頻度を下げ且つコストを低く抑えることができ、患者Ｐの生活の質を向上させることが可能となる。 After adjusting the circumferential length L and connecting the two end portions 2a and 2b of the main body 2, the head portion 11 and the tail portion 12 are cut off to a range that does not hinder the connecting means 4 (see FIG. 1), two holes 21a, Block 21b.
Since the sphincter device 1 has the urging means 3 as described above, the patient P can open and close the anus K without performing any special operation, and the complexity during defecation can be reduced. In addition, since only one part remains in the body, the invasion of the patient P can be kept low, and the very simple structure can reduce the frequency of maintenance and the cost, thereby reducing the life of the patient P. The quality can be improved.

したがって、本発明に係る括約筋装置１は、近年の高齢化に伴い患者Ｐが増加している括約筋Ｍの機能障害に有効である。
括約筋Ｍの機能障害は、加齢によって骨盤底筋群が脆弱となることで生じ、便Ｎの失禁をきたしたり、括約筋Ｍ機能の低下によって直腸脱の症状を併発する。これらの症状をきたした患者Ｐの肛門静止圧Ｓは多くの場合、２０ｍｍＨｇより低下しているが、括約筋装置１を用いることによって２０ｍｍＨｇ以上まで肛門静止圧Ｓを上げ、便失禁や直腸脱の症状を改善又は消失させることができる。なお、高齢者のように腹圧が弱い患者Ｐの場合には、肛門静止圧Ｓを５０ｍｍＨｇ以下とする。 Therefore, the sphincter apparatus 1 according to the present invention is effective for functional disorders of the sphincter muscle M in which the number of patients P is increasing with the recent aging.
The dysfunction of the sphincter muscle M is caused by weakening of the pelvic floor muscle group with aging, resulting in incontinence of the stool N, or the symptoms of rectal prolapse due to a decrease in the function of the sphincter muscle M. Although the anal resting pressure S of the patient P having these symptoms is often lower than 20 mmHg, the anal resting pressure S is increased to 20 mmHg or more by using the sphincter device 1, and symptoms of fecal incontinence and rectal prolapse are observed. Can be improved or eliminated. In addition, in the case of the patient P whose abdominal pressure is weak like an elderly person, the anal resting pressure S shall be 50 mmHg or less.

図５〜７には、第２実施形態に係る括約筋装置１が示されている。
第２実施形態においては、頭部１１が先細り且つ牽引糸２２で引っ張るように形成されている点と、本体２の幅が第１実施形態の約２分の１となっている点とが異なっている。
図５、６に示すように、第２実施形態の本体２及び尾部１２は、左右幅が約１０ｍｍとなっており、第１実施形態の幅（約６ｍｍ）の略半分に形成している。これによって、適正な肛門静止圧Ｓを保つと同時に、本体２より上流側且つ肛門Ｋ内の便Ｎを患者Ｐが腹圧で下流へ押し出した際には肛門Ｋが拡開しうる伸縮性を確保しながら、埋め込む際の傷口を小さくし、患者Ｐに対する侵襲を可及的に小さくすることができる。なお、本体２及び尾部１２の長さ、厚みは、第１実施形態と略同一である。 The sphincter apparatus 1 which concerns on 2nd Embodiment is shown by FIGS.
In the second embodiment, the head 11 is tapered and formed so as to be pulled by the traction thread 22, and the width of the main body 2 is about half that of the first embodiment. ing.
As shown in FIGS. 5 and 6, the main body 2 and the tail portion 12 of the second embodiment have a lateral width of about 10 mm and are formed to be approximately half the width (about 6 mm) of the first embodiment. As a result, an appropriate anal static pressure S can be maintained, and at the same time, the patient K can be stretched to expand the anus K when the patient P pushes the stool N in the anus K upstream from the body 2 by abdominal pressure. While ensuring, the wound at the time of implantation can be made small, and the invasion to the patient P can be made as small as possible. In addition, the length and thickness of the main body 2 and the tail part 12 are substantially the same as in the first embodiment.

図５、６で示す如く、頭部１１は、硬度が４０°であって、本体２の一端部２ａから前方へ延設した胴体部１１ａと、この胴体部１１ａの一端側（先端側）から延設された先端部１１ｂとを有している。頭部１１は、その延設方向（軸心方向）と本体２の長手方向とが略沿うように本体２の一端側に一体形成されている。
胴体部１１ａは、略円柱状に形成され、所定の長さ（約２５ｍｍ）、直径（約６ｍｍ）とすることで、後述するように、括約筋装置１が頭部１１を先頭として体内で進むのに必要な強度を有している。また、胴体部１１ａの基端側は、本体２の上面及び下面と略面一につながるテーパ面が設けられている。 As shown in FIGS. 5 and 6, the head 11 has a hardness of 40 °, and extends from the one end 2 a of the main body 2 to the front, and from one end (tip side) of the trunk 11 a. It has the extended front-end | tip part 11b. The head 11 is integrally formed on one end side of the main body 2 so that the extending direction (axial direction) and the longitudinal direction of the main body 2 are substantially along.
The trunk portion 11a is formed in a substantially cylindrical shape and has a predetermined length (about 25 mm) and diameter (about 6 mm), so that the sphincter device 1 advances in the body with the head 11 as the head, as will be described later. Has the necessary strength. Moreover, the base end side of the trunk | drum 11a is provided with the taper surface connected with the upper surface and lower surface of the main body 2, and a substantially flush surface.

先端部１１ｂは、胴体部１１ａの先端側に一体的に設けられた先細り状の略円錐形であって、その頂角は約６０°で高さは約５ｍｍである。
前記胴体部１１ａの周面に周溝１１ｃが設けられている。この周溝１１ｃは、先端部１１ｂの基端側から所定距離（約５ｍｍ）離れた後方に胴体部１１ａの周方向に沿って形成されている。この周溝１１ｃから先端部１１ｂの途中までにわたる頭部１１の左右側部には、頭部１１の長さ方向に延びる縦溝１１ｄがそれぞれ設けられている。 The distal end portion 11b is a tapered substantially conical shape integrally provided on the distal end side of the body portion 11a. The apex angle is about 60 ° and the height is about 5 mm.
A circumferential groove 11c is provided on the circumferential surface of the body portion 11a. The circumferential groove 11c is formed along the circumferential direction of the body portion 11a on the rear side at a predetermined distance (about 5 mm) from the proximal end side of the distal end portion 11b. Longitudinal grooves 11d extending in the length direction of the head 11 are provided on the left and right sides of the head 11 extending from the circumferential groove 11c to the middle of the tip 11b.

この縦溝１１ｄは、その底面が前記周溝１１ｃの底面と略面一状に連通している。
なお、周溝１１ｃ及び縦溝１１ｄは、後述の牽引糸２２を巻き付けたり、嵌め込んだりできるような所定の深さ（約１ｍｍ）及び幅（約１ｍｍ）に設定されている。
第２実施形態に係る括約筋装置１の使用態様について説明する。
第２実施形態の使用形態において、第１実施形態で用いる鉗子２０よりも細い鉗子を用いる点とが異なっている。 The bottom surface of the vertical groove 11d communicates with the bottom surface of the circumferential groove 11c in a substantially flush manner.
In addition, the circumferential groove 11c and the vertical groove 11d are set to a predetermined depth (about 1 mm) and width (about 1 mm) so that a pulling thread 22 described later can be wound or fitted.
A usage mode of the sphincter device 1 according to the second embodiment will be described.
The use form of the second embodiment is different from the use of forceps thinner than the forceps 20 used in the first embodiment.

図７（ａ）に示したように、肛門Ｋに周囲に穴２１ａ、２１ｂを開け、一方の穴２１ａから頭部１１を挿入し、括約筋装置１が肛門Ｋの括約筋Ｍ外周をまわって他方の穴２１ｂから頭部１１を出せるように、体内で引っ張るための牽引糸２２を頭部１１に取り付ける。
頭部１１の周溝１１ｃに牽引糸２２を巻き付け、この牽引糸２２の余った両方の端部２２Ａを左右の縦溝１１ｄに沿わせながら頭部１１前方に持ってくる。この両端部２２Ａを細い鉗子（図示省略）の先端に巻き付けて、この細い鉗子を使って先に両端部２２Ａを一方の穴２１ａから他方の穴２１ｂに通す。 As shown in FIG. 7 (a), holes 21a and 21b are opened around the anus K, the head 11 is inserted through one hole 21a, and the sphincter device 1 rotates around the outer periphery of the sphincter M of the anus K. A pulling thread 22 for pulling inside the body is attached to the head 11 so that the head 11 can be taken out from the hole 21b.
The traction thread 22 is wound around the circumferential groove 11c of the head 11 and both ends 22A of the traction thread 22 are brought forward in front of the head 11 along the left and right vertical grooves 11d. The two end portions 22A are wound around the tip of a thin forceps (not shown), and the two end portions 22A are first passed from one hole 21a to the other hole 21b using the thin forceps.

他方の穴２１ｂから出した牽引糸２２の両端部２２Ａを引っ張ることによって、括約筋装置１が括約筋Ｍの周りを半周まわって肛門Ｋを周辺に配置される。
さらに、牽引糸２２の両端部２２Ａを他方の穴２１ｂから一方の穴２１ａに通した後に、括約筋Ｍの残り外周半分を巡らすことで、括約筋装置１は、頭部１１及び尾部１２が一方の穴２１ａから外部に露出する（図７（ｂ）参照）。 By pulling both ends 22A of the pulling thread 22 from the other hole 21b, the sphincter device 1 is placed around the sphincter M and placed around the anus K around the sphincter M.
Further, after passing the two end portions 22A of the pulling thread 22 from the other hole 21b to the one hole 21a, the sphincter device 1 has the head 11 and the tail portion 12 in one hole through the remaining outer half of the sphincter M. 21a is exposed to the outside (see FIG. 7B).

このように、牽引糸２２を細い鉗子で引っ張って、括約筋装置１を肛門Ｋ周辺に配置することで、埋め込み時に使用する道具の小型化が図られ、さらなる侵襲の抑制が実現できる。
その他の括約筋装置１の構成、作用効果及び使用態様は、第１実施形態と同様である。
本発明は、前述した実施形態に限定されるものではない。括約筋装置１等の各構成又は全体の構造、形状、寸法などは、本発明の趣旨に沿って適宜変更することができる。 In this way, by pulling the traction thread 22 with thin forceps and placing the sphincter device 1 around the anus K, the tool used at the time of implantation can be reduced in size, and further suppression of invasion can be realized.
Other configurations, functions and effects of the sphincter device 1 are the same as those in the first embodiment.
The present invention is not limited to the embodiment described above. Each configuration of the sphincter device 1 or the like, or the overall structure, shape, dimensions, and the like can be appropriately changed in accordance with the spirit of the present invention.

括約筋装置１は、肛門Ｋに用いるだけでなく、尿道に用いてもよく、この場合、腹圧性尿失禁等を起こした患者Ｐに対して尿道を取り囲むように体内へ挿入する。また、この場合、内容物Ｎは尿となる。
括約筋装置１は、本体２を、拒絶反応が起きにくいチタン、銅合金などの金属で形成した略円弧状に湾曲した複数の棒状部材で構成し、各棒状部材をつなぐシリコンゴム等の伸縮自在な繋ぎ部材を付勢手段３としてもよい。 The sphincter device 1 may be used not only for the anus K but also for the urethra. In this case, the sphincter device 1 is inserted into the body so as to surround the urethra for a patient P who has experienced stress urinary incontinence. In this case, the content N is urine.
The sphincter device 1 is composed of a plurality of rod-like members curved in a substantially arc shape formed of a metal such as titanium, copper alloy, etc., in which rejection reaction is unlikely to occur, and a stretchable material such as silicon rubber that connects the rod-like members. The connecting member may be the urging means 3.

また、括約筋装置１は、本体２が器官の管部Ｋを洗濯バサミ状に挟む一対の把持部材であってもよく、その把持部材を巻バネ、板バネなどの付勢手段３によって管部Ｋを挟む方向に付勢してもよい。この場合、把持部材、付勢手段３はチタン、銅合金などの金属製とする。
さらに、括約筋装置１は、シリコンゴムで形成しなくてもよく、ポリオレフィン繊維などの他の生体適合材料によって形成してもよい。 Further, the sphincter device 1 may be a pair of gripping members in which the main body 2 sandwiches the organ tube portion K in the shape of a clothespin, and the gripping member is connected to the tube portion K by a biasing means 3 such as a winding spring or a leaf spring. You may bias in the direction which pinches | interposes. In this case, the holding member and the biasing means 3 are made of metal such as titanium or copper alloy.
Furthermore, the sphincter device 1 may not be formed of silicon rubber, but may be formed of other biocompatible materials such as polyolefin fibers.

括約筋装置１をシリコンゴムで形成した場合、本体２によって、適正な肛門静止圧Ｓを保つとともに、患者Ｐが腹圧で便Ｎを下流へ押し出したときに肛門Ｋが拡開可能であるならば、その硬度は、２０°や４０°でなくてもよく、約１０°以上約６０°以下であってもよい。
括約筋装置１は、頭部１１や尾部１２を有していなくてもよい。 If the sphincter device 1 is formed of silicone rubber, the body 2 maintains an appropriate anal static pressure S, and the anus K can be expanded when the patient P pushes the stool N downstream with abdominal pressure. The hardness may not be 20 ° or 40 °, but may be about 10 ° or more and about 60 ° or less.
The sphincter device 1 may not have the head portion 11 and the tail portion 12.

括約筋装置１の硬度は、部分的に変えてもよく、本体２の長手方向における中途部分の硬度を両端部２ａ、２ｂより下げたものや、頭部１１、連結孔１３、連結突起１４等の硬度を他の部位より上げたものとしてもよい、
本体２の左右幅は、約６ｍｍや約１０ｍｍでなくともよく、約４ｍｍ以上約１８ｍｍ以下、好ましくは約６ｍｍ以上約１６ｍｍ以下、さらに好ましくは約８ｍｍ以上約１２ｍｍ以下であってもよい。 The hardness of the sphincter device 1 may be partially changed, such as the one in which the hardness of the midway portion in the longitudinal direction of the main body 2 is lowered from both end portions 2a, 2b, the head 11, the connecting hole 13, the connecting protrusion 14, etc. It is good also as what raised hardness from other parts.
The left-right width of the main body 2 may not be about 6 mm or about 10 mm, but may be about 4 mm or more and about 18 mm or less, preferably about 6 mm or more and about 16 mm or less, more preferably about 8 mm or more and about 12 mm or less.

連結手段４は、連結孔１３を連結突起１４に挿通させて抜け止めするものでなく、両端部２ａ、２ｂを接着、融解したり、チタン等で形成したハトメ、カシメ、ステープラーなどの固定具や、糸、紐によって止めるものとしてもよい。
頭部１１は、略平板状や略円錐状でなく、鉗子２０で掴みやすいように頭部１１に孔を開けたリング状であってもよい。 The connecting means 4 does not prevent the connecting hole 13 from being inserted through the connecting protrusion 14 but also attaches and melts both end portions 2a and 2b, or a fixing tool such as eyelet, caulking or stapler formed of titanium or the like. It is good also as what stops with a thread | yarn and a string.
The head 11 may not be substantially flat or conical, but may be a ring having a hole in the head 11 so that the head 11 can be easily grasped.

連結孔１３は、５つでなくともよく、最低でも連結突起１４の数よりも１以上多く、１０個以下であってもよい。連結孔１３の直径は、約１ｍｍでなくても、約０．５ｍｍ以上約２ｍｍ以下であってもよい。
連結突起１４は、連結孔１３に嵌入可能であるならば、突起胴部１４ａの直径が約２ｍｍでなくとも、約２ｍｍ以上約６ｍｍ以下であればよく、突起頭部１４ｂの直径が約４ｍｍでなくとも、約４ｍｍ以上約１２ｍｍ以下であればよい。 The number of connecting holes 13 is not limited to five, and may be at least 1 and 10 or less than the number of connecting protrusions 14 at the minimum. The diameter of the connection hole 13 may not be about 1 mm, but may be about 0.5 mm or more and about 2 mm or less.
As long as the connecting protrusion 14 can be fitted into the connecting hole 13, the diameter of the protrusion body 14 a may be about 2 mm to about 6 mm, and the diameter of the protrusion head 14 b is about 4 mm, even if the diameter is not about 2 mm. Even if it is not, it should just be about 4 mm or more and about 12 mm or less.

１ 括約筋装置
２ 本体
２ａ 本体の一端部
２ｂ 本体の他端部
３ 付勢手段
４ 連結手段
Ｋ 器官の管部（肛門）
Ｎ 内容物
Ｆ 付勢力
Ｌ 囲い長さ
Ｓ 肛門静止圧 DESCRIPTION OF SYMBOLS 1 Sphincter apparatus 2 Main body 2a One end part of a main body 2b The other end part of a main body 3 Energizing means 4 Connecting means K Organ pipe part (anus)
N Contents F Energizing force L Enclosure length S Anal static pressure

本発明は、肛門、尿道などの器官の管部周囲に配置された括約筋装置に関するものである。   The present invention relates to a sphincter device disposed around a tube portion of an organ such as an anus or urethra.

従来、器官の管部のために人体に埋没可能な人工括約筋装置が知られている。
この人工括約筋装置は、管部の周りに配置されるようになっており、膨張時に管部の周りに閉じ且つ管部を閉鎖し、且つ収縮時に管部を開く膨張可能な可撓性カフと、カフの周りに配置され且つカフに締着され、且つ膨張時管部から外方へ真直ぐにされ且つ開くように処置された膨張可能な可撓性リザバーリングと、カフ及びリングを相互連結する流体通路と、流体をカフからリザバーリングへ移送する装置とを備えている（特許文献１参照）。 2. Description of the Related Art Conventionally, an artificial sphincter device that can be buried in a human body for an organ tube is known.
The artificial sphincter device is adapted to be placed around a tube portion, an inflatable flexible cuff that closes and closes the tube portion when inflated and opens the tube portion when contracted. Interconnecting the cuff and the ring with an inflatable flexible reservoir ring disposed about the cuff and fastened to the cuff and straightened outwardly from the tube when inflated and treated to open A fluid passage and a device for transferring fluid from the cuff to the reservoir ring are provided (see Patent Document 1).

特公平６−３８８０８号公報Japanese Examined Patent Publication No. 6-38808

上記従来の人工括約筋装置は、管部を開閉させるためには、その都度ポンプや加熱回路を切換操作しなくてはならない構造であって、排泄時の操作性が悪い。
また、管部を開閉するカフ以外に、上述のポンプ及び加熱回路や、リザバーリング、３つの流体伝達ライン、運動制御リング及びコイルなどの多くの部材を体内の複数箇所に埋め込む必要があり、人体に大きな侵襲を負わせる。 The conventional artificial sphincter device has a structure in which the pump and the heating circuit must be switched each time to open and close the tube portion, and the operability during excretion is poor.
In addition to the cuff that opens and closes the pipe, it is necessary to embed many members such as the pump and heating circuit, the reservoir ring, the three fluid transmission lines, the motion control ring, and the coil at multiple locations in the body. Can be very invasive.

さらに、人工括約筋装置から体内に流体が漏れたり、電気回路が故障するなどの虞や、構造が複雑なためにメンテナンスの困難性やコスト高などの問題もある。
本発明は、このような問題点に鑑みて、器官の管部を取り囲む本体より上流側で且つ管部内の内容物を腹圧で下流へ押圧することによって拡開可能に管部を閉塞する付勢手段を有することで、管部を開閉する切換操作を必要とせず、部品点数の減少及び構造の簡素化
を実現して、人体にかかる侵襲を低く抑え、メンテナンス性及び経済性を上げ、括約筋機能が低下した患者の生活の質を向上させる括約筋装置を提供することを目的とする。 In addition, there is a risk of fluid leaking from the artificial sphincter device into the body or failure of an electric circuit, and problems such as difficulty in maintenance and high costs due to the complicated structure.
In view of such a problem, the present invention attaches the tube portion so that the tube portion can be expanded by pressing the contents in the tube portion downstream from the main body surrounding the tube portion of the organ and the abdominal pressure. By having a biasing means, switching operation to open and close the pipe part is not required, reducing the number of parts and simplifying the structure, keeping the invasion on the human body low, improving maintenance and economy, and sphincter The object is to provide a sphincter device that improves the quality of life of patients with reduced function.

前記課題を達成するために、本発明は、以下の技術的手段を採用した。
肛門Ｋを取り囲んで閉塞した長尺で略平板状シリコンゴム製の本体２によって、この本体２より上流側且つ前記肛門Ｋ内の内容物Ｎを腹圧で下流へ押圧した際に前記肛門Ｋが拡開可能な付勢力Ｆで前記肛門Ｋを閉塞方向に付勢して便失禁を伴う括約筋不全をきたした括約筋Ｍをサポート又は代用し、
前記長尺な本体２の一端部に連結孔１３が穿孔され、他端部に前記連結孔１３へ挿通する連結突起１４が本体２と一体的に立設され、
前記連結突起１４は、前記連結孔１３より大径な突起胴部１４ａと、この突起胴部１４ａより大径で且つ前記本体２による付勢中に挿通した連結孔１３からの抜けを止める突起頭部１４ｂとを有していて、
前記略平板状シリコンゴム製の本体２に、引っ張り把持可能に端部から長手方向外方に延設した部位１１、１２を本体２と一体的に設けている。 In order to achieve the above object, the present invention employs the following technical means.
When the body 2 made of a substantially flat silicon rubber that surrounds and closes the anus K is pressed upstream of the body 2 and the contents N in the anus K downstream by abdominal pressure, the anus K Supporting or substituting the sphincter muscle M that has caused sphincter insufficiency accompanied by fecal incontinence by urging the anus K in the closing direction with an urging force F that can be expanded,
Said elongate coupling hole 13 at one end of the main body 2 are drilled, the connecting projection 14 to be inserted into the coupling hole 13 to the other end portion is integrally erected and the body 2,
The connection protrusion 14 has a protrusion body portion 14a having a diameter larger than that of the connection hole 13, and a protrusion head that has a diameter larger than that of the protrusion body portion 14a and prevents the connection hole 13 from being pulled out during urging by the main body 2. Part 14b ,
On the substantially flat silicone rubber body 2, the portions 11 and 12 extending longitudinally outward from tensile graspable to end that have provided integrally with the main body 2.

また、前記肛門Ｋを取り囲んだ本体２によって肛門静止圧Ｓが２０ｍｍＨｇ以上１２０ｍｍＨｇ以下となる前記付勢力Ｆ下で前記連通孔１３へ連結突起１４を挿通すべく、
前記本体２に一端縁から所定間隔ごとに複数穿孔された略円形の前記連結孔１３より少数の前記連結突起１４を、前記他端部に前記所定間隔ごとに断面略円形状に複数立設していて、
前記本体２は、硬度が１０°以上６０°以下で且つ幅が４ｍｍ以上１８ｍｍ以下に形成されている。 Further, in order by a pre-body 2 surrounding the Ki肛 Gate K in the force F under the anal resting pressure S is less 120mmHg above 20mmHg to inserting the connecting protrusion 14 into the communication hole 13,
Small number of the coupling projections 14 than substantially circular of the connecting hole 13 in which a plurality perforated at predetermined intervals from one edge to the main body 2, a plurality stand and set to a substantially circular cross section for each of the predetermined intervals to the other end Tei Te,
The body 2, hardness and width that are formed below 4mm or 18mm at 10 ° to 60 °.

さらに、前記本体２は、前記連結突起１４より硬度が低い部位を有している。
そして、本発明は、次の特徴を有する。
第１に、器官の管部Ｋを取り囲んで閉塞した本体２と、この本体２より上流側且つ前記管部Ｋ内の内容物Ｎを腹圧で下流へ押圧した際に前記管部Ｋが拡開可能な付勢力Ｆで前記管部Ｋを閉塞方向に付勢した付勢手段３とを有していることを特徴とする。 Further, the main body 2 has a portion whose hardness is lower than that of the connection protrusion 14 .
And this invention has the following characteristics.
First, the main body 2 surrounding and closing the tube portion K of the organ, and the tube portion K expands when the contents N in the tube portion K upstream of the main body 2 are pressed downstream by abdominal pressure. And an urging means 3 that urges the tube portion K in the closing direction with an urging force F that can be opened.

第２に、前記管部Ｋは、肛門Ｋであって、
前記付勢手段３を、長尺のシリコンゴムで形成された前記本体２によって構成し、
前記本体２は、前記肛門Ｋを取り囲んだ時に一端部２ａと他端部２ｂとを連結する連結手段４を囲い長さＬ調整自在に備えていることを特徴とする。
第３に、前記付勢力Ｆを、前記本体２で肛門Ｋを取り囲んだ時の肛門静止圧Ｓが２０ｍｍＨｇ以上１２０ｍｍＨｇ以下となるように設定していることを特徴とする。 Second, the tube K is an anus K,
The urging means 3 is constituted by the main body 2 formed of a long silicon rubber,
The main body 2 includes a connecting means 4 for connecting the one end portion 2a and the other end portion 2b when the anus K is surrounded, so that the length L is adjustable.
Thirdly, the urging force F is set so that an anal static pressure S when the body 2 surrounds the anus K is 20 mmHg or more and 120 mmHg or less.

これらの特徴により、管部Ｋを取り囲む本体２と、管部Ｋ内の内容物Ｎを腹圧で下流へ押圧した際に拡開可能な付勢力Ｆで管部Ｋを閉塞する付勢手段３とを有することで、特段の操作なしに管部Ｋの開閉が可能となり、使用者Ｐの煩雑さを低減できる。そして、必要な部品点数を減らして人体への負担を抑えるとともに、簡単な構造となるためメンテナンスの必要がほとんどなく且つコストを低く抑えることができ、使用者Ｐの生活の質を向上させる。   Due to these characteristics, the main body 2 surrounding the pipe part K and the urging means 3 for closing the pipe part K with an urging force F that can be expanded when the contents N in the pipe part K are pressed downstream by abdominal pressure. The tube portion K can be opened and closed without any special operation, and the complexity of the user P can be reduced. And while reducing the number of necessary parts and reducing the burden on the human body, since it has a simple structure, there is almost no need for maintenance and the cost can be kept low, and the quality of life of the user P is improved.

また、付勢手段３を、長尺のシリコンゴムで形成された本体２で付勢手段３を構成することで、さらなる部品点数の減少及び管部Ｋである肛門Ｋ周囲への埋め込みの容易化を図り、肛門Ｋを取り囲んだ状態で本体２の一端部２ａと他端部２ｂとを連結する連結手段４を囲い長さＬ調整自在に備えることで、肛門Ｋを閉塞する付勢力Ｆを使用者Ｐに応じて調整することができる。   Further, the urging means 3 is constituted by the main body 2 formed of a long silicon rubber, thereby further reducing the number of parts and facilitating implantation around the anus K that is the tube portion K. The urging force F that closes the anus K is used by providing the connecting means 4 that connects the one end 2a and the other end 2b of the main body 2 with the length L adjustable while surrounding the anus K. Can be adjusted according to the person P.

さらに、本体２で肛門Ｋを取り囲んだ時の肛門静止圧Ｓが２０ｍｍＨｇ以上１２０ｍｍＨｇ以下となるように付勢力Ｆを設定することで、内容物Ｎの漏れを防止すると同時に、適度な腹圧で容易に肛門Ｋを拡開できるようになる。   Furthermore, by setting the urging force F so that the anal static pressure S when the anus K is surrounded by the main body 2 is 20 mmHg or more and 120 mmHg or less, leakage of the contents N is prevented and at the same time easy with moderate abdominal pressure The anus K can be expanded.

本発明に係る括約筋装置によると、管部を取り囲んだ本体と、管部内の内容物を腹圧で下流へ押圧した際に管部が拡開可能な付勢力で管部を閉塞付勢した付勢手段とを有するこ
とで、管部の開閉に伴う煩雑な切換操作をなくし、部品点数の減少によって侵襲を抑え、構造の簡素化によってメンテナンス性及び経済性の向上を図ることができる。 According to the sphincter apparatus according to the present invention, the main body that surrounds the pipe section and the biasing force that closes and biases the pipe section with a biasing force that allows the pipe section to expand when the contents in the pipe section are pressed downstream by abdominal pressure. By having the biasing means, it is possible to eliminate a complicated switching operation associated with the opening and closing of the pipe part, to suppress the invasion by reducing the number of parts, and to improve the maintainability and economy by simplifying the structure.

第１実施形態に係る括約筋装置を体内に埋め込んだ際の斜視図である。It is a perspective view at the time of embedding the sphincter apparatus which concerns on 1st Embodiment in a body. 括約筋装置の平面図である。It is a top view of a sphincter device. 括約筋装置の側面図である。It is a side view of a sphincter device. 括約筋装置の使用態様を示す概要図である。It is a schematic diagram which shows the usage condition of a sphincter device. 第２実施形態に係る括約筋装置の平面図である。It is a top view of the sphincter device concerning a 2nd embodiment. 括約筋装置の側面図である。It is a side view of a sphincter device. 括約筋装置の使用態様を示す概要図である。It is a schematic diagram which shows the usage condition of a sphincter device.

以下、本発明の実施の形態を図面を参照して説明する。
図１〜４には、本発明の第１実施形態に係る括約筋装置１が示されている。
この括約筋装置１は、略紐状でのシリコンゴムであって、使用者（患者）Ｐの肛門Ｋを取り囲むように体内に埋め込まれ、長手方向に伸縮自在に形成されている。
括約筋装置１は、長尺の本体２と、この本体２の一端部２ａ及び他端部２ｂを連結する連結手段４と、本体２の一端部２ａに設けられた頭部１１と、本体２の他端部２ｂに設けられた尾部１２とを一体として形成している。 Hereinafter, embodiments of the present invention will be described with reference to the drawings.
1-4 show a sphincter device 1 according to a first embodiment of the present invention.
This sphincter device 1 is a substantially string-like silicone rubber, is embedded in the body so as to surround an anus K of a user (patient) P, and is formed to be stretchable in the longitudinal direction.
The sphincter device 1 includes a long main body 2, connecting means 4 for connecting one end 2 a and the other end 2 b of the main body 2, a head 11 provided at one end 2 a of the main body 2, The tail part 12 provided in the other end part 2b is integrally formed.

なお、括約筋装置１の硬度は、頭部１１及び後述の連結突起１４は硬度４０°であり、これら以外の部分は硬度２０°となっている。また、本発明における硬度の単位は、「ＪＩＳ Ｋ ６２５３」や「ＩＳＯ４８」、「ＩＳＯ７６１９」に準拠している。
図２、３に示すように、本体２は、肛門Ｋを取り囲みうる所定長さ（本実施形態では約８５ｍｍ）を有した略帯状であって、所定の左右幅（約１０ｍｍ）、厚み（約２ｍｍ）とすることで、本体２の伸縮性を十分に確保できる。また、本体２は、一端部２ａ側に複数穿設された連結孔１３（本実施形態では５つ）と、他端部２ｂ側に複数突設された連結突起１４（本実施形態では２つ）とを有している。 The sphincter device 1 has a hardness of 40 ° at the head 11 and a connecting projection 14 described later, and a hardness of 20 ° at other portions. The unit of hardness in the present invention is in conformity with “JIS K 6253”, “ISO48”, and “ISO7619”.
As shown in FIGS. 2 and 3, the main body 2 has a substantially band shape having a predetermined length (about 85 mm in the present embodiment) that can surround the anus K, and has a predetermined left-right width (about 10 mm) and thickness (about about 2 mm), the stretchability of the main body 2 can be sufficiently secured. The main body 2 includes a plurality of connecting holes 13 (five in this embodiment) drilled on one end 2a side and a plurality of connecting projections 14 (two in this embodiment) projecting on the other end 2b side. ).

連結孔１３は、後述する連結突起１４の突起胴部１４ａよりも小さい直径（約１ｍｍ）であって、本体２の一端縁から所定間隔（約５ｍｍ）ごと複数箇所に穿孔されている。
連結突起１４は、本体２の上面から立設した突起胴部１４ａと、この突起胴部１４ａの上端に設けられたフランジ状の突起頭部１４ｂとを有している。突起胴部１４ａは、略円柱状であって、直径は前記連結孔１３よりも大径（約２ｍｍ）で、高さが本体２の厚みと略同じ（約２ｍｍ）である。突起頭部１４ｂは、突起胴部１４ａよりも大径（約４ｍｍ）の略円盤状であって、後述するように連結突起１４を連結孔１３に通した際、突起頭部１４ｂ自体が弾性変形して抜けないような所定の厚さ（約１ｍｍ）を有している。 The connection hole 13 has a diameter (about 1 mm) smaller than a protrusion body portion 14a of the connection protrusion 14 to be described later, and is drilled at a plurality of locations at predetermined intervals (about 5 mm) from one end edge of the main body 2.
The connection protrusion 14 has a protrusion body portion 14 a erected from the upper surface of the main body 2 and a flange-shaped protrusion head portion 14 b provided at the upper end of the protrusion body portion 14 a. The protrusion body portion 14a has a substantially cylindrical shape, and has a diameter larger than that of the connection hole 13 (about 2 mm) and a height substantially the same as the thickness of the main body 2 (about 2 mm). The protruding head 14b has a substantially disk shape with a larger diameter (about 4 mm) than the protruding body 14a. When the connecting protrusion 14 is passed through the connecting hole 13 as will be described later, the protruding head 14b itself is elastically deformed. And has a predetermined thickness (about 1 mm) so as not to come off.

連結突起１４は、シリコンゴムで本体２と一体的に形成されており、連結孔１３は径方向に、連結突起１４は径方向及び軸心方向に伸び縮み自在である。
つまり、連結突起１４は、連結孔１３を拡開して本体２の下面から入れ込み、突起頭部１４ｂを本体２上面側に出すことができ、これによって、連結突起１４の連結孔１３に対する抜け止めがなされる。 The connection protrusion 14 is formed integrally with the main body 2 with silicon rubber, and the connection hole 13 can expand and contract in the radial direction, and the connection protrusion 14 can expand and contract in the radial direction and the axial direction.
That is, the connecting projection 14 can be inserted from the lower surface of the main body 2 by expanding the connecting hole 13, and the protruding head 14 b can be brought out to the upper surface side of the main body 2, thereby preventing the connecting projection 14 from coming off from the connecting hole 13. Is made.

また、２つの連結突起１４を５つ中２つの連結孔１３に挿入することで、本体２で肛門Ｋを取り囲んだ状態で本体２の一端部２ａと他端部２ｂとがリング状に連結される。
つまり、連結孔１３と連結突起１４とで連結手段４を構成している。
また、本体２が２カ所で抜け止めされるため、両端部２ａ、２ｂ連結時の本体２の向き決め（一端部２ａにおける長手方向と、他端部２ｂにおける長手方向とを略揃えること）が可能となる。 Further, by inserting the two connecting projections 14 into the two connecting holes 13 out of the five, the one end 2a and the other end 2b of the main body 2 are connected in a ring shape with the main body 2 surrounding the anus K. The
That is, the connection means 4 is constituted by the connection hole 13 and the connection protrusion 14.
Further, since the main body 2 is prevented from coming off at two locations, the orientation of the main body 2 when the both end portions 2a and 2b are connected (the longitudinal direction at the one end portion 2a and the longitudinal direction at the other end portion 2b are substantially aligned). It becomes possible.

さらに、連結突起１４を挿入する連結孔１３を５つの内から２つ選択可能であるため、本体２は、連結手段４によって肛門Ｋの取り囲む長さ（周長さ）Ｌを調整自在に構成されている。
図２、３に示す如く、頭部１１は、本体２の一端部２ａから前方に延設していて、幅及び厚みが前記本体２と略同一（幅が約１０ｍｍ、厚みが略２ｍｍ）の略平板状である。頭
部１１の長さは、後述するように、括約筋装置１が体内で進む際に頭部１１を鉗子（ペアン鉗子等）２０で掴むのに必要な所定長さ（約２０ｍｍ）を有している。 Furthermore, since two connection holes 13 for inserting the connection protrusions 14 can be selected from among the five, the main body 2 is configured such that the length (circumferential length) L surrounding the anus K can be adjusted by the connection means 4. ing.
As shown in FIGS. 2 and 3, the head 11 extends forward from one end 2 a of the main body 2, and has the same width and thickness as the main body 2 (width is about 10 mm, thickness is about 2 mm). It is substantially flat. As will be described later, the length of the head 11 has a predetermined length (about 20 mm) necessary for grasping the head 11 with forceps (Pean forceps or the like) 20 when the sphincter device 1 advances in the body. Yes.

頭部１１は、先端から上下に盛り上がった隆起部１５を有している。この隆起部１５は、頭部１１先端の左右縁にわたって形成されており、括約筋装置１を体内で鉗子２０を用いて引っ張る際に把持しやすい形状となっている。
図２、３に示されたように、前記尾部１２は、略帯状であって、本体２の他端部２ｂから後方へ延設している。尾部１２は、本体２の後方側の連結突起１４から末端までの長さが所定長さ（約５０ｍｍ）を有している。また、尾部１２は、本体２と略同一の幅、厚みを有していて、末端の角は落として丸く形成されている。 The head 11 has a raised portion 15 that rises up and down from the tip. The raised portion 15 is formed over the left and right edges of the distal end of the head 11 and has a shape that is easy to grasp when the sphincter device 1 is pulled using the forceps 20 in the body.
As shown in FIGS. 2 and 3, the tail 12 has a substantially band shape and extends rearward from the other end 2 b of the main body 2. The tail portion 12 has a predetermined length (about 50 mm) from the connecting projection 14 on the rear side of the main body 2 to the end. The tail portion 12 has substantially the same width and thickness as the main body 2 and is rounded with the corners of the ends dropped.

第１実施形態に係る括約筋装置１の使用態様について説明する。
図４（ａ）に示したように、肛門Ｋの周囲に括約筋装置１を挿入するための穴２１ａ、２１ｂを半周ずらして２カ所（肛門Ｋの大きさによっては３分の１周ずらして３カ所）開ける。
括約筋装置１を一方の穴２１ａから埋め込む際には、他方の穴２１ｂから鉗子２０を挿入して肛門Ｋの外周を２分の１周まわし、一方の穴２１ａから鉗子２０の先端を出す。 A usage mode of the sphincter device 1 according to the first embodiment will be described.
As shown in FIG. 4 (a), the holes 21a and 21b for inserting the sphincter device 1 around the anus K are shifted by half a circle at two places (depending on the size of the anus K, the holes are shifted by a third to 3). F) Open.
When the sphincter device 1 is embedded from one hole 21a, the forceps 20 is inserted from the other hole 21b, the outer circumference of the anus K is turned by half, and the tip of the forceps 20 is taken out from the one hole 21a.

出された鉗子２０の先端で頭部１１を挟みながら、括約筋装置１を体内に引き込む。そして、他方の穴２１ｂから鉗子２０を引き出すことにつれ、括約筋装置１の頭部１１が他方の穴２１ｂから露出する。このように、括約筋装置１は、鉗子２０を使って、肛門Ｋの外周を２分の１周まわすように体内に埋め込まれる。
残り２分の１周も、同様に、一方の穴２１ａから挿入した鉗子２０で頭部１１を挟んだ状態で鉗子２０を引き抜くことで、肛門Ｋの周囲を取り囲むように体内に配置される。 The sphincter device 1 is pulled into the body while the head 11 is sandwiched between the tips of the extracted forceps 20. Then, as the forceps 20 is pulled out from the other hole 21b, the head 11 of the sphincter device 1 is exposed from the other hole 21b. In this way, the sphincter device 1 is implanted in the body using the forceps 20 so that the outer circumference of the anus K is turned by half.
Similarly, the remaining half of the circumference is arranged in the body so as to surround the periphery of the anus K by pulling out the forceps 20 with the head 11 sandwiched between the forceps 20 inserted from one hole 21a.

このとき、括約筋装置１は、所定長さを有した頭部１１及び尾部１２が一方の穴２１ａから外部に露出した状態となっている（図４（ｂ）参照）。この頭部１１及び尾部１２を掴んで引き出すことで、本体２の一端部２ａと他端部２ｂとの両方が、一方の穴２１ａから外部に露出した状態となる。この露出している一端部２ａの連結孔１３に、他端部２ｂの連結突起１４を挿入して、括約筋装置１をリング状に連結して、肛門Ｋを取り囲むように配置する。   At this time, the sphincter device 1 is in a state in which the head 11 and tail 12 having a predetermined length are exposed to the outside from one hole 21a (see FIG. 4B). By grasping and pulling out the head portion 11 and the tail portion 12, both the one end portion 2a and the other end portion 2b of the main body 2 are exposed to the outside through the one hole 21a. The connecting projection 13 of the other end 2b is inserted into the exposed connecting hole 13 of the one end 2a, and the sphincter device 1 is connected in a ring shape so as to surround the anus K.

また、患者Ｐに応じて、括約筋装置１は、肛門Ｋを取り囲む周長さＬを調整して連結される。この周長さＬは、肛門内圧測定器２３の細長いセンサ部２３ａを肛門Ｋに差し込み肛門静止圧Ｓを測りながら、２つの連結突起１４を任意の２つの連結孔１３に通して抜け止めすることで決定される。
なお、肛門静止圧Ｓとは、患者Ｐの無意識下でも内容物（便）Ｎが肛門Ｋから漏れない圧であって、肛門静止圧Ｓを適切な値とすることで、排便時以外に便Ｎが漏れることがなくなる。 Moreover, according to the patient P, the sphincter apparatus 1 is connected by adjusting the circumferential length L surrounding the anus K. This circumferential length L is obtained by inserting the elongated sensor portion 23a of the intraanal pressure measuring instrument 23 into the anus K and measuring the anal resting pressure S to prevent the two connecting protrusions 14 from passing through any two connecting holes 13. Determined by
The anal resting pressure S is a pressure at which the contents (stool) N does not leak from the anus K even under the unconsciousness of the patient P. By setting the anal resting pressure S to an appropriate value, the rest N will not leak.

この肛門静止圧Ｓが２０ｍｍＨｇ以上１２０ｍｍＨｇ以下、好ましくは、３０ｍｍＨｇ以上８０ｍｍＨｇ以下、さらに好ましくは３０ｍｍＨｇ以上５０ｍｍＨｇ以下となるように、周長さＬを調整する。また、肛門静止圧Ｓは、患者Ｐの括約筋Ｍをサポート又は代用するように、肛門Ｋを取り囲んで閉塞するように連結された本体２の弾性力（付勢力）Ｆによって生じている。   The peripheral length L is adjusted so that the anal static pressure S is 20 mmHg or more and 120 mmHg or less, preferably 30 mmHg or more and 80 mmHg or less, and more preferably 30 mmHg or more and 50 mmHg or less. The anal static pressure S is generated by the elastic force (biasing force) F of the main body 2 connected so as to surround and close the anus K so as to support or substitute for the sphincter M of the patient P.

また、本体２は、硬度２０°のシリコンゴム製であり、付勢力Ｆによって適正な肛門静止圧Ｓを保つと同時に、本体２より上流側且つ肛門Ｋ内の便Ｎを患者Ｐが腹圧で下流へ押し出した際には肛門Ｋが拡開しうる伸縮性を有している。
すなわち、この伸縮する本体２によって、括約筋装置１の付勢手段３が構成されている。 Further, the main body 2 is made of silicon rubber having a hardness of 20 °, and an appropriate anal static pressure S is maintained by the urging force F, and at the same time, the patient P has the abdominal pressure on the stool N upstream of the main body 2 and in the anus K. When pushed out downstream, the anus K has a stretchability that allows it to expand.
That is, the urging means 3 of the sphincter device 1 is constituted by the expanding and contracting main body 2.

周長さＬを調整して本体２の両端部２ａ、２ｂを連結した後で、頭部１１、尾部１２を連結手段４に支障がない範囲まで切り落とし（図１参照）、２つの穴２１ａ、２１ｂを塞ぐ。
括約筋装置１が、上述したような付勢手段３を有することで、患者Ｐは、特段の操作をしなくとも肛門Ｋの開閉ができ、排便時の煩雑さを低減できる。また、体内に残る部品が１つだけであるため、患者Ｐの侵襲を低く抑えるとともに、非常に簡単な構造であるため
メンテナンスの頻度を下げ且つコストを低く抑えることができ、患者Ｐの生活の質を向上させることが可能となる。 After adjusting the circumferential length L and connecting the two end portions 2a and 2b of the main body 2, the head portion 11 and the tail portion 12 are cut off to a range that does not hinder the connecting means 4 (see FIG. 1), two holes 21a, Block 21b.
Since the sphincter device 1 has the urging means 3 as described above, the patient P can open and close the anus K without performing any special operation, and the complexity during defecation can be reduced. In addition, since only one part remains in the body, the invasion of the patient P can be kept low, and the very simple structure can reduce the frequency of maintenance and the cost, thereby reducing the life of the patient P. The quality can be improved.

したがって、本発明に係る括約筋装置１は、近年の高齢化に伴い患者Ｐが増加している括約筋Ｍの機能障害に有効である。
括約筋Ｍの機能障害は、加齢によって骨盤底筋群が脆弱となることで生じ、便Ｎの失禁をきたしたり、括約筋Ｍ機能の低下によって直腸脱の症状を併発する。これらの症状をきたした患者Ｐの肛門静止圧Ｓは多くの場合、２０ｍｍＨｇより低下しているが、括約筋装置１を用いることによって２０ｍｍＨｇ以上まで肛門静止圧Ｓを上げ、便失禁や直腸脱の症状を改善又は消失させることができる。なお、高齢者のように腹圧が弱い患者Ｐの場合には、肛門静止圧Ｓを５０ｍｍＨｇ以下とする。 Therefore, the sphincter apparatus 1 according to the present invention is effective for functional disorders of the sphincter muscle M in which the number of patients P is increasing with the recent aging.
The dysfunction of the sphincter muscle M is caused by weakening of the pelvic floor muscle group with aging, resulting in incontinence of the stool N, or the symptoms of rectal prolapse due to a decrease in the function of the sphincter muscle M. Although the anal resting pressure S of the patient P having these symptoms is often lower than 20 mmHg, the anal resting pressure S is increased to 20 mmHg or more by using the sphincter device 1, and symptoms of fecal incontinence and rectal prolapse are observed. Can be improved or eliminated. In addition, in the case of the patient P whose abdominal pressure is weak like an elderly person, the anal resting pressure S shall be 50 mmHg or less.

図５〜７には、第２実施形態に係る括約筋装置１が示されている。
第２実施形態においては、頭部１１が先細り且つ牽引糸２２で引っ張るように形成されている点と、本体２の幅が第１実施形態の約２分の１となっている点とが異なっている。
図５、６に示すように、第２実施形態の本体２及び尾部１２は、左右幅が約１０ｍｍとなっており、第１実施形態の幅（約６ｍｍ）の略半分に形成している。これによって、適正な肛門静止圧Ｓを保つと同時に、本体２より上流側且つ肛門Ｋ内の便Ｎを患者Ｐが腹圧で下流へ押し出した際には肛門Ｋが拡開しうる伸縮性を確保しながら、埋め込む際の傷口を小さくし、患者Ｐに対する侵襲を可及的に小さくすることができる。なお、本体２及び尾部１２の長さ、厚みは、第１実施形態と略同一である。 The sphincter apparatus 1 which concerns on 2nd Embodiment is shown by FIGS.
In the second embodiment, the head 11 is tapered and formed so as to be pulled by the traction thread 22, and the width of the main body 2 is about half that of the first embodiment. ing.
As shown in FIGS. 5 and 6, the main body 2 and the tail portion 12 of the second embodiment have a lateral width of about 10 mm and are formed to be approximately half the width (about 6 mm) of the first embodiment. As a result, an appropriate anal static pressure S can be maintained, and at the same time, the patient K can be stretched to expand the anus K when the patient P pushes the stool N in the anus K upstream from the body 2 by abdominal pressure. While ensuring, the wound at the time of implantation can be made small, and the invasion to the patient P can be made as small as possible. In addition, the length and thickness of the main body 2 and the tail part 12 are substantially the same as in the first embodiment.

図５、６で示す如く、頭部１１は、硬度が４０°であって、本体２の一端部２ａから前方へ延設した胴体部１１ａと、この胴体部１１ａの一端側（先端側）から延設された先端部１１ｂとを有している。頭部１１は、その延設方向（軸心方向）と本体２の長手方向とが略沿うように本体２の一端側に一体形成されている。
胴体部１１ａは、略円柱状に形成され、所定の長さ（約２５ｍｍ）、直径（約６ｍｍ）とすることで、後述するように、括約筋装置１が頭部１１を先頭として体内で進むのに必要な強度を有している。また、胴体部１１ａの基端側は、本体２の上面及び下面と略面一につながるテーパ面が設けられている。 As shown in FIGS. 5 and 6, the head 11 has a hardness of 40 °, and extends from the one end 2 a of the main body 2 to the front, and from one end (tip side) of the trunk 11 a. It has the extended front-end | tip part 11b. The head 11 is integrally formed on one end side of the main body 2 so that the extending direction (axial direction) and the longitudinal direction of the main body 2 are substantially along.
The trunk portion 11a is formed in a substantially cylindrical shape and has a predetermined length (about 25 mm) and diameter (about 6 mm), so that the sphincter device 1 advances in the body with the head 11 as the head, as will be described later. Has the necessary strength. Moreover, the base end side of the trunk | drum 11a is provided with the taper surface connected with the upper surface and lower surface of the main body 2, and a substantially flush surface.

先端部１１ｂは、胴体部１１ａの先端側に一体的に設けられた先細り状の略円錐形であって、その頂角は約６０°で高さは約５ｍｍである。
前記胴体部１１ａの周面に周溝１１ｃが設けられている。この周溝１１ｃは、先端部１１ｂの基端側から所定距離（約５ｍｍ）離れた後方に胴体部１１ａの周方向に沿って形成されている。この周溝１１ｃから先端部１１ｂの途中までにわたる頭部１１の左右側部には、頭部１１の長さ方向に延びる縦溝１１ｄがそれぞれ設けられている。 The distal end portion 11b is a tapered substantially conical shape integrally provided on the distal end side of the body portion 11a. The apex angle is about 60 ° and the height is about 5 mm.
A circumferential groove 11c is provided on the circumferential surface of the body portion 11a. The circumferential groove 11c is formed along the circumferential direction of the body portion 11a on the rear side at a predetermined distance (about 5 mm) from the proximal end side of the distal end portion 11b. Longitudinal grooves 11d extending in the length direction of the head 11 are provided on the left and right sides of the head 11 extending from the circumferential groove 11c to the middle of the tip 11b.

この縦溝１１ｄは、その底面が前記周溝１１ｃの底面と略面一状に連通している。
なお、周溝１１ｃ及び縦溝１１ｄは、後述の牽引糸２２を巻き付けたり、嵌め込んだりできるような所定の深さ（約１ｍｍ）及び幅（約１ｍｍ）に設定されている。
第２実施形態に係る括約筋装置１の使用態様について説明する。
第２実施形態の使用形態において、第１実施形態で用いる鉗子２０よりも細い鉗子を用いる点とが異なっている。 The bottom surface of the vertical groove 11d communicates with the bottom surface of the circumferential groove 11c in a substantially flush manner.
In addition, the circumferential groove 11c and the vertical groove 11d are set to a predetermined depth (about 1 mm) and width (about 1 mm) so that a pulling thread 22 described later can be wound or fitted.
A usage mode of the sphincter device 1 according to the second embodiment will be described.
The use form of the second embodiment is different from the use of forceps thinner than the forceps 20 used in the first embodiment.

図７（ａ）に示したように、肛門Ｋに周囲に穴２１ａ、２１ｂを開け、一方の穴２１ａから頭部１１を挿入し、括約筋装置１が肛門Ｋの括約筋Ｍ外周をまわって他方の穴２１ｂから頭部１１を出せるように、体内で引っ張るための牽引糸２２を頭部１１に取り付ける。
頭部１１の周溝１１ｃに牽引糸２２を巻き付け、この牽引糸２２の余った両方の端部２２Ａを左右の縦溝１１ｄに沿わせながら頭部１１前方に持ってくる。この両端部２２Ａを細い鉗子（図示省略）の先端に巻き付けて、この細い鉗子を使って先に両端部２２Ａを一方の穴２１ａから他方の穴２１ｂに通す。 As shown in FIG. 7 (a), holes 21a and 21b are opened around the anus K, the head 11 is inserted through one hole 21a, and the sphincter device 1 rotates around the outer periphery of the sphincter M of the anus K. A pulling thread 22 for pulling inside the body is attached to the head 11 so that the head 11 can be taken out from the hole 21b.
The traction thread 22 is wound around the circumferential groove 11c of the head 11 and both ends 22A of the traction thread 22 are brought forward in front of the head 11 along the left and right vertical grooves 11d. The two end portions 22A are wound around the tip of a thin forceps (not shown), and the two end portions 22A are first passed from one hole 21a to the other hole 21b using the thin forceps.

他方の穴２１ｂから出した牽引糸２２の両端部２２Ａを引っ張ることによって、括約筋装置１が括約筋Ｍの周りを半周まわって肛門Ｋを周辺に配置される。
さらに、牽引糸２２の両端部２２Ａを他方の穴２１ｂから一方の穴２１ａに通した後に
、括約筋Ｍの残り外周半分を巡らすことで、括約筋装置１は、頭部１１及び尾部１２が一方の穴２１ａから外部に露出する（図７（ｂ）参照）。 By pulling both ends 22A of the pulling thread 22 from the other hole 21b, the sphincter device 1 is placed around the sphincter M and placed around the anus K around the sphincter M.
Further, after passing the two end portions 22A of the pulling thread 22 from the other hole 21b to the one hole 21a, the sphincter device 1 has the head 11 and the tail portion 12 in one hole through the remaining outer half of the sphincter M. 21a is exposed to the outside (see FIG. 7B).

このように、牽引糸２２を細い鉗子で引っ張って、括約筋装置１を肛門Ｋ周辺に配置することで、埋め込み時に使用する道具の小型化が図られ、さらなる侵襲の抑制が実現できる。
その他の括約筋装置１の構成、作用効果及び使用態様は、第１実施形態と同様である。
本発明は、前述した実施形態に限定されるものではない。括約筋装置１等の各構成又は全体の構造、形状、寸法などは、本発明の趣旨に沿って適宜変更することができる。 In this way, by pulling the traction thread 22 with thin forceps and placing the sphincter device 1 around the anus K, the tool used at the time of implantation can be reduced in size, and further suppression of invasion can be realized.
Other configurations, functions and effects of the sphincter device 1 are the same as those in the first embodiment.
The present invention is not limited to the embodiment described above. Each configuration of the sphincter device 1 or the like, or the overall structure, shape, dimensions, and the like can be appropriately changed in accordance with the spirit of the present invention.

括約筋装置１は、肛門Ｋに用いるだけでなく、尿道に用いてもよく、この場合、腹圧性尿失禁等を起こした患者Ｐに対して尿道を取り囲むように体内へ挿入する。また、この場合、内容物Ｎは尿となる。
括約筋装置１は、本体２を、拒絶反応が起きにくいチタン、銅合金などの金属で形成した略円弧状に湾曲した複数の棒状部材で構成し、各棒状部材をつなぐシリコンゴム等の伸縮自在な繋ぎ部材を付勢手段３としてもよい。 The sphincter device 1 may be used not only for the anus K but also for the urethra. In this case, the sphincter device 1 is inserted into the body so as to surround the urethra for a patient P who has experienced stress urinary incontinence. In this case, the content N is urine.
The sphincter device 1 is composed of a plurality of rod-like members curved in a substantially arc shape formed of a metal such as titanium, copper alloy, etc., in which rejection reaction is unlikely to occur, and a stretchable material such as silicon rubber that connects the rod-like members. The connecting member may be the urging means 3.

また、括約筋装置１は、本体２が器官の管部Ｋを洗濯バサミ状に挟む一対の把持部材であってもよく、その把持部材を巻バネ、板バネなどの付勢手段３によって管部Ｋを挟む方向に付勢してもよい。この場合、把持部材、付勢手段３はチタン、銅合金などの金属製とする。
さらに、括約筋装置１は、シリコンゴムで形成しなくてもよく、ポリオレフィン繊維などの他の生体適合材料によって形成してもよい。 Further, the sphincter device 1 may be a pair of gripping members in which the main body 2 sandwiches the organ tube portion K in the shape of a clothespin, and the gripping member is connected to the tube portion K by a biasing means 3 such as a winding spring or a leaf spring. You may bias in the direction which pinches | interposes. In this case, the holding member and the biasing means 3 are made of metal such as titanium or copper alloy.
Furthermore, the sphincter device 1 may not be formed of silicon rubber, but may be formed of other biocompatible materials such as polyolefin fibers.

括約筋装置１をシリコンゴムで形成した場合、本体２によって、適正な肛門静止圧Ｓを保つとともに、患者Ｐが腹圧で便Ｎを下流へ押し出したときに肛門Ｋが拡開可能であるならば、その硬度は、２０°や４０°でなくてもよく、約１０°以上約６０°以下であってもよい。
括約筋装置１は、頭部１１や尾部１２を有していなくてもよい。 If the sphincter device 1 is formed of silicone rubber, the body 2 maintains an appropriate anal static pressure S, and the anus K can be expanded when the patient P pushes the stool N downstream with abdominal pressure. The hardness may not be 20 ° or 40 °, but may be about 10 ° or more and about 60 ° or less.
The sphincter device 1 may not have the head portion 11 and the tail portion 12.

括約筋装置１の硬度は、部分的に変えてもよく、本体２の長手方向における中途部分の硬度を両端部２ａ、２ｂより下げたものや、頭部１１、連結孔１３、連結突起１４等の硬度を他の部位より上げたものとしてもよい、
本体２の左右幅は、約６ｍｍや約１０ｍｍでなくともよく、約４ｍｍ以上約１８ｍｍ以下、好ましくは約６ｍｍ以上約１６ｍｍ以下、さらに好ましくは約８ｍｍ以上約１２ｍｍ以下であってもよい。 The hardness of the sphincter device 1 may be partially changed, such as the one in which the hardness of the midway portion in the longitudinal direction of the main body 2 is lowered from both end portions 2a, 2b, the head 11, the connecting hole 13, the connecting protrusion 14, etc. It is good also as what raised hardness from other parts.
The left-right width of the main body 2 may not be about 6 mm or about 10 mm, but may be about 4 mm or more and about 18 mm or less, preferably about 6 mm or more and about 16 mm or less, more preferably about 8 mm or more and about 12 mm or less.

連結手段４は、連結孔１３を連結突起１４に挿通させて抜け止めするものでなく、両端部２ａ、２ｂを接着、融解したり、チタン等で形成したハトメ、カシメ、ステープラーなどの固定具や、糸、紐によって止めるものとしてもよい。
頭部１１は、略平板状や略円錐状でなく、鉗子２０で掴みやすいように頭部１１に孔を開けたリング状であってもよい。 The connecting means 4 does not prevent the connecting hole 13 from being inserted through the connecting protrusion 14 but also attaches and melts both end portions 2a and 2b, or a fixing tool such as eyelet, caulking or stapler formed of titanium or the like. It is good also as what stops with a thread | yarn and a string.
The head 11 may not be substantially flat or conical, but may be a ring having a hole in the head 11 so that the head 11 can be easily grasped.

連結孔１３は、５つでなくともよく、最低でも連結突起１４の数よりも１以上多く、１０個以下であってもよい。連結孔１３の直径は、約１ｍｍでなくても、約０．５ｍｍ以上約２ｍｍ以下であってもよい。
連結突起１４は、連結孔１３に嵌入可能であるならば、突起胴部１４ａの直径が約２ｍｍでなくとも、約２ｍｍ以上約６ｍｍ以下であればよく、突起頭部１４ｂの直径が約４ｍｍでなくとも、約４ｍｍ以上約１２ｍｍ以下であればよい。 The number of connecting holes 13 is not limited to five, and may be at least 1 and 10 or less than the number of connecting protrusions 14 at the minimum. The diameter of the connection hole 13 may not be about 1 mm, but may be about 0.5 mm or more and about 2 mm or less.
As long as the connecting protrusion 14 can be fitted into the connecting hole 13, the diameter of the protrusion body 14 a may be about 2 mm to about 6 mm, and the diameter of the protrusion head 14 b is about 4 mm, even if the diameter is not about 2 mm. Even if it is not, it should just be about 4 mm or more and about 12 mm or less.

１ 括約筋装置
２ 本体
２ａ 本体の一端部
２ｂ 本体の他端部
３ 付勢手段
４ 連結手段
Ｋ 器官の管部（肛門）
Ｎ 内容物
Ｆ 付勢力
Ｌ 囲い長さ
Ｓ 肛門静止圧 DESCRIPTION OF SYMBOLS 1 Sphincter apparatus 2 Main body 2a One end part of a main body 2b The other end part of a main body 3 Energizing means 4 Connecting means K Organ pipe part (anus)
N Contents F Energizing force L Enclosure length S Anal static pressure

Claims (3)

器官の管部（Ｋ）を取り囲んで閉塞した本体（２）と、この本体（２）より上流側且つ前記管部（Ｋ）内の内容物（Ｎ）を腹圧で下流へ押圧した際に前記管部（Ｋ）が拡開可能な付勢力（Ｆ）で前記管部（Ｋ）を閉塞方向に付勢した付勢手段（３）とを有していることを特徴とする括約筋装置。   When the body (2) surrounding and closing the tube (K) of the organ and the content (N) in the tube (K) upstream from the body (2) are pressed downstream by abdominal pressure. A sphincter device comprising urging means (3) for urging the tube (K) in the closing direction with an urging force (F) that allows the tube (K) to expand. 前記管部（Ｋ）は、肛門（Ｋ）であって、
前記付勢手段（３）を、長尺のシリコンゴムで形成された前記本体（２）によって構成し、
前記本体（２）は、前記肛門（Ｋ）を取り囲んだ時に一端部（２ａ）と他端部（２ｂ）とを連結する連結手段（４）を囲い長さ（Ｌ）調整自在に備えていることを特徴とする請求項１に記載の括約筋装置。 The tube (K) is an anus (K),
The urging means (3) is constituted by the main body (2) formed of a long silicon rubber,
The main body (2) includes a connecting means (4) for connecting the one end (2a) and the other end (2b) when the anus (K) is surrounded so that the length (L) can be adjusted. The sphincter device according to claim 1. 前記付勢力（Ｆ）を、前記本体（２）で肛門（Ｋ）を取り囲んだ時の肛門静止圧（Ｓ）が２０ｍｍＨｇ以上１２０ｍｍＨｇ以下となるように設定していることを特徴とする請求項２に記載の括約筋装置。   The urging force (F) is set so that an anal resting pressure (S) when the body (2) surrounds the anus (K) is 20 mmHg or more and 120 mmHg or less. The sphincter device described in 1.
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JPS62164459A (en) * 1986-01-14 1987-07-21 水尾　敏之 Artificial urethra sphincter
WO2001060283A2 (en) * 2000-02-17 2001-08-23 American Medical Systems, Inc. Locking cuff sizer and method for measuring girth of a body passage
JP2006129979A (en) * 2004-11-04 2006-05-25 Yufu Itonaga Co Ltd Elastic tape for proctocele surgery
WO2006107901A1 (en) * 2005-04-04 2006-10-12 Micardia Corporation Dynamic reinforcement of the lower esophageal sphincter
JP2008510590A (en) * 2004-08-25 2008-04-10 パヴァド・メディカル・インコーポレーテッド Artificial sphincter
JP2008237786A (en) * 2007-03-29 2008-10-09 Tohoku Univ Artificial sphincter
FR2929840A1 (en) * 2008-04-14 2009-10-16 Cie Euro Etude Rech Paroscopie UNDERGROUND LOCK RING

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JPS62164459A (en) * 1986-01-14 1987-07-21 水尾　敏之 Artificial urethra sphincter
WO2001060283A2 (en) * 2000-02-17 2001-08-23 American Medical Systems, Inc. Locking cuff sizer and method for measuring girth of a body passage
JP2008510590A (en) * 2004-08-25 2008-04-10 パヴァド・メディカル・インコーポレーテッド Artificial sphincter
JP2006129979A (en) * 2004-11-04 2006-05-25 Yufu Itonaga Co Ltd Elastic tape for proctocele surgery
WO2006107901A1 (en) * 2005-04-04 2006-10-12 Micardia Corporation Dynamic reinforcement of the lower esophageal sphincter
JP2008237786A (en) * 2007-03-29 2008-10-09 Tohoku Univ Artificial sphincter
FR2929840A1 (en) * 2008-04-14 2009-10-16 Cie Euro Etude Rech Paroscopie UNDERGROUND LOCK RING

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