JP6868867B2 - Medical materials - Google Patents

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JP6868867B2
JP6868867B2 JP2017140003A JP2017140003A JP6868867B2 JP 6868867 B2 JP6868867 B2 JP 6868867B2 JP 2017140003 A JP2017140003 A JP 2017140003A JP 2017140003 A JP2017140003 A JP 2017140003A JP 6868867 B2 JP6868867 B2 JP 6868867B2
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porous layer
tubular portion
medical material
tubular
substantially central
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JP2019017795A (en
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裕嗣 黒部
裕嗣 黒部
佐藤　秀樹
秀樹 佐藤
亜矢 中江
亜矢 中江
美枝子 石川
美枝子 石川
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Gunze Ltd
University of Tokushima
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University of Tokushima
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Description

本発明は、生体組織に形成された欠損孔を治療するための医療用材料に関し、特に、カテーテルにセットされて血管内を通じて治療部位まで送り込まれて生体内に留置される医療用材料に関する。 The present invention relates to a medical material for treating a defect formed in a living tissue, and more particularly to a medical material which is set in a catheter and sent to a treatment site through a blood vessel and indwelled in the living body.

人間の心臓は中隔という組織で左右の部屋が仕切られており、左右それぞれに心房と心室とがあり、右心房、右心室、左心房、左心室の２心房２心室で構成されている。このような構成の心臓において、胎児期の発達障害により、先天的に欠損孔と呼ばれる穴が、右心房と左心房とを隔てる心房中隔に開いている心房中隔欠損症（ＡＳＤ：Ａｔｒｉａｌ Ｓｅｐｔａｌ Ｄｅｆｅｃｔ）という疾患がある。 The human heart is divided into left and right chambers by a tissue called the septum, and each has an atrium and a ventricle on the left and right, and is composed of two atriums and two ventricles, a right atrium, a right ventricle, a left atrium, and a left ventricle. Atrial septal defect (ASD), in which a hole called a defect hole is congenitally opened in the atrial septum that separates the right atrium and the left atrium due to developmental disorders during the fetal period in the heart having such a structure. There is a disease called Defect).

この心房中隔欠損症の治療としては、以下に示す２つの方法がある。ひとつは胸を切って行う外科手術、もうひとつが胸を切らずに、閉鎖栓を使ったカテーテル治療である。
外科手術（パッチ手術）は、人工心肺を使用し、開胸して、欠損孔をパッチにて閉じる。カテーテル治療は、カテーテルに閉鎖栓をセットし、カテーテルを血管内に挿入し、目的の位置（欠損孔）まで送り込んで、その後、閉鎖栓を放出し体内に留置する。このカテーテル治療では胸を切開しないで足の付け根の静脈（大腿静脈）から、細長く折り畳んだ閉鎖栓とよばれる小さな治具（デバイス）を心房中隔に開いた穴の位置まで送り込み、穴を塞ぐものである。このカテーテル治療の長所は、全身麻酔が必要な開胸手術をすることなく、足の付け根（そけい部）という目立たない場所から、ごく小さな皮膚の切開（数ミリ）で治療ができる点である。 There are the following two methods for treating this atrial septal defect. One is surgery performed by cutting the chest, and the other is catheter treatment using a closure plug without cutting the chest.
Surgery (patch surgery) uses an artificial heart-lung machine, opens the chest, and closes the defect hole with a patch. In catheter treatment, a closing plug is set in the catheter, the catheter is inserted into a blood vessel, the catheter is delivered to a target position (defective hole), and then the closing plug is released and placed in the body. In this catheter treatment, a small jig (device) called an elongated folded closure plug is sent from the vein at the base of the foot (femoral vein) to the position of the hole opened in the atrial septum without incising the chest to close the hole. It is a thing. The advantage of this catheter treatment is that it can be treated with a very small skin incision (several millimeters) from an inconspicuous place at the base of the foot (stomach) without performing thoracotomy that requires general anesthesia. ..

特表２００８−５１２１３９号公報（特許文献１）は、心房中隔欠損症のカテーテル治療に用いられるアセンブリ（閉鎖栓）を開示する。このアセンブリは、心臓の通路（欠損孔）を密閉する。このアセンブリは、通路の第一端の近位に配置するために使用される第一アンカー、通路の第二端の近位に配置するために使用される第二アンカー、および通路を通って伸び、第一および第二アンカーに結合するために使用される可撓性延長材を含む心臓の通路を密閉する閉鎖装置からなり、第二アンカーは可撓性延長材に対して移動可能で第一および第二アンカーの間の可撓性延長材の長さを変更し、閉鎖装置を心臓の通路に供給する供給システムからなり、供給装置はガイドカテーテルの内腔の中を移動するように設定され、第二アンカーの可撓性延長材に沿った運動を制御するワイヤーを含む。 Japanese Patent Application Laid-Open No. 2008-512139 (Patent Document 1) discloses an assembly (closure plug) used for catheter treatment of atrial septal defect. This assembly seals the passage (defective hole) of the heart. This assembly extends through a first anchor used to be located proximal to the first end of the aisle, a second anchor used to be located proximal to the second end of the aisle, and a passage. Consists of a closure device that seals the passage of the heart, including a flexible extension used to connect to the first and second anchors, the second anchor being movable relative to the flexible extension, first It consists of a supply system that changes the length of the flexible extension between the and second anchors and supplies the closure device to the passage of the heart, the supply device being set to move through the lumen of the guide catheter. Includes wires that control movement along the flexible extension of the second anchor.

そして、この特許文献１において、卵円孔開存（ＰＦＯ：Ｐａｔｅｎｔ Ｏｖａｌ Ｆｏｒａｍｅｎ）閉鎖装置（閉鎖栓）は、左心房アンカー、右心房アンカー、テザーおよびロックを含み、左心房アンカー、テザーを介して左心房アンカーに結合する右心房アンカーおよびロックは心臓内に残留してＰＦＯを密閉することが開示されている。 Then, in Patent Document 1, the patent foramen ovale (PFO) closing device (closing plug) includes a left atrium anchor, a right atrium anchor, a tether and a lock, and is via the left atrium anchor and the tether. It is disclosed that the right atrial anchor and lock that bind to the left atrial anchor remain in the heart and seal the PFO.

特表２００８−５１２１３９号公報Japanese Patent Application Laid-Open No. 2008-512139

パッチ手術の場合には、人工心肺を使用し、また、侵襲性が高いため入院期間が長くなるという問題がある。カテーテル治療の場合には、人工心肺は使用せず、また、侵襲性も低いため入院期間も短く好ましい。
特許文献１に開示されるように、左心房アンカーおよび右心房アンカーは心臓内に残留する。そして、左心房アンカーおよび右心房アンカーは一つまたはそれ以上のアームを含み、アームはハブから放射状に外側に向かって伸びており、このアームは好適には二成分ニッケルチタン合金の圧延シートから形成されている。そして、これらの左心房アンカーおよび右心房アンカーを生体内で拡張させて欠損孔を塞ぐことになるが、アンカーの拡張を開始させると、容易には元に戻すことはできない。特許文献１に開示されているような、複雑な構造で、かつ、生体外からの操作が難しい、専用の取出し装置を用いてアンカー
を折りたたむことになる。 In the case of patch surgery, there is a problem that an artificial heart-lung machine is used and the length of hospital stay is long due to its high invasiveness. In the case of catheter treatment, an artificial heart-lung machine is not used, and since it is less invasive, the length of hospital stay is short, which is preferable.
As disclosed in Patent Document 1, the left atrium anchor and the right atrium anchor remain in the heart. The left atrium anchor and the right atrium anchor include one or more arms, which extend radially outward from the hub, which arms are preferably formed from rolled sheets of binary nickel titanium alloy. Has been done. Then, these left atrium anchors and right atrium anchors are expanded in vivo to close the defect hole, but once the anchor expansion is started, it cannot be easily restored. The anchor is folded using a dedicated extraction device having a complicated structure and difficult to operate from outside the living body as disclosed in Patent Document 1.

しかしながら、たとえば、アンカーが心房内の生体組織に引っ掛かり傷付ける等の事態になった場合には、このような専用の取出し装置でアンカーを折りたたむだけの時間的余裕がない場合もある。このような場合には、開胸手術に即座に切り換えざるを得ない。これでは、結局、侵襲性が高い開胸手術を受けることになるという問題点がある。
さらに、金属製の欠損孔閉鎖栓が体内に一生涯残存するため、遠隔期の不具合が懸念されるという問題点がある。 However, for example, when the anchor is caught in a living tissue in the atrium and is injured, there may be no time to fold the anchor with such a dedicated extraction device. In such cases, there is no choice but to switch to open chest surgery immediately. This has the problem of eventually undergoing highly invasive thoracotomy.
Further, since the metal defect hole closure plug remains in the body for a lifetime, there is a problem that there is a concern about a problem in a remote period.

本発明は、従来技術の上記の問題点に鑑みて開発されたものであり、その目的とするところは、生体内の治療部位にて放出・留置できる低侵襲のカテーテル治療を、複雑な構造を備えず容易な操作で可能となり、体内に残存しても遠隔期の不具合の可能性がほとんどない、医療用材料を提供することを目的とする。 The present invention has been developed in view of the above-mentioned problems of the prior art, and an object of the present invention is to provide a minimally invasive catheter treatment that can be released and placed at a treatment site in a living body, and to have a complicated structure. The purpose is to provide medical materials that can be easily operated without being prepared and that have almost no possibility of malfunction in the remote period even if they remain in the body.

上記目的を達成するため、本発明に係る医療用材料は以下の技術的手段を講じている。
すなわち、本発明に係る医療用材料は、線材を用いた編み目状組織の筒体により形成された医療用材料であって、前記筒体の略中央部の筒径が他の部分の筒径よりも小さい形状を備え、前記略中央部を中心にして前記医療用材料における筒体長手方向の第１の端部側の第１の筒部と他の端部側の第２の筒部とが形成され、前記第１の端部の線材と前記第２の端部の線材とにそれぞれ両端が係合され、前記第１の端部側から前記略中央部を介して前記第２の端部側まで前記第１の筒部および前記第２の筒部の内部に通された弾性部材を備え、不織布、スポンジ、フィルムおよびこれらの複合体のいずれかから構成された多孔質層が前記筒体の内面の３箇所に前記内面に沿うようにそれぞれ配置され、前記第１の筒部の長手方向における略中央部側に第１の多孔質層が、前記第２の筒部の長手方向における略中央部の反対側に第２の多孔質層が、前記第１の筒部の長手方向における略中央部の反対側に第３の多孔質層が、それぞれ配置され、前記第３の多孔質層は、前記第１の多孔質層および第２の多孔質層よりも長手方向が短いことを特徴とする。 In order to achieve the above object, the medical material according to the present invention takes the following technical measures.
That is, the medical material according to the present invention is a medical material formed by a tubular body having a stitch-like structure using a wire rod, and the tubular diameter at a substantially central portion of the tubular body is larger than the tubular diameter of another portion. Also has a small shape, and the first tubular portion on the first end side in the longitudinal direction of the tubular body and the second tubular portion on the other end side of the medical material are formed around the substantially central portion. Both ends are engaged with the wire rod of the first end portion and the wire rod of the second end portion, respectively, and the second end portion is formed from the first end portion side via the substantially central portion. The tubular body includes an elastic member that is passed through the inside of the first tubular portion and the second tubular portion to the side, and a porous layer composed of a non-woven fabric, a sponge, a film, or a composite thereof. The first porous layer is arranged along the inner surface at three locations on the inner surface of the first tubular portion in the longitudinal direction of the first tubular portion, and the first porous layer is substantially on the central portion side in the longitudinal direction of the first tubular portion. A second porous layer is arranged on the opposite side of the central portion, and a third porous layer is arranged on the opposite side of the substantially central portion in the longitudinal direction of the first tubular portion. Is characterized in that the longitudinal direction is shorter than that of the first porous layer and the second porous layer.

好ましくは、前記形状は、砂時計型、８の字型または２連の紡錘型であって、前記３箇所に設けられる多孔質層は、前記形状に沿った傘形状を備えるように構成することができる。
さらに好ましくは、前記弾性部材が収縮状態であるときに、前記第１の端部と前記第２の端部とが前記略中央部を中心にして接近して、前記医療用材料により閉鎖される欠損孔に対応した大きさまで前記他の部分の筒径が拡張され、前記他の部分の筒径が拡張することに伴い、前記第１の多孔質層および前記第２の多孔質層が、前記医療用材料により閉鎖される欠損孔に対応した大きさまで拡張されるように構成することができる。 Preferably, the shape is an hourglass type, a figure eight shape or a double spindle type, and the porous layers provided at the three locations may be configured to have an umbrella shape along the shape. it can.
More preferably, when the elastic member is in the contracted state, the first end portion and the second end portion approach each other about the substantially central portion and are closed by the medical material. As the cylinder diameter of the other portion is expanded to a size corresponding to the defect hole and the cylinder diameter of the other portion is expanded, the first porous layer and the second porous layer are expanded. It can be configured to expand to a size corresponding to the defect hole closed by the medical material.

さらに好ましくは、前記弾性部材が伸張状態であるときに、前記第１の端部と前記第２の端部とが前記略中央部を中心にして離隔して、前記医療用材料が収納されるカテーテルに対応した大きさまで前記他の部分の筒径が縮小され、前記他の部分の筒径が縮小することに伴い、前記第１の多孔質層、前記第２の多孔質層および前記第３の多孔質層が、前記医療用材料が収納されるカテーテルに対応した大きさまで縮小されるように構成することができる。 More preferably, when the elastic member is in the stretched state, the first end portion and the second end portion are separated from each other about the substantially central portion, and the medical material is stored. The diameter of the other portion is reduced to a size corresponding to the catheter, and as the diameter of the other portion is reduced, the first porous layer, the second porous layer, and the third porous layer are reduced. The porous layer of the above can be configured to be reduced in size to accommodate the catheter in which the medical material is housed.

さらに好ましくは、前記弾性部材は、前記略中央部の筒径よりも直径が小さいコイルばねであるように構成することができる。
さらに好ましくは、前記弾性部材の端部は、前記編み目状組織の筒体の外部に設けられた小筒部であって操作ワイヤーと螺合可能な小筒部と接合されているように構成することができる。 More preferably, the elastic member can be configured to be a coil spring having a diameter smaller than the cylinder diameter at the substantially central portion.
More preferably, the end portion of the elastic member is configured so as to be a small cylinder portion provided outside the tubular body of the stitch-like structure and joined to the small cylinder portion screwable with the operation wire. be able to.

さらに好ましくは、前記線材または前記多孔質層は、生体吸収性材料であるように構成することができる。 More preferably, the wire rod or the porous layer can be configured to be a bioabsorbable material.

本発明の医療用材料によれば、生体内の治療部位にて放出・留置できる低侵襲のカテーテル治療を、複雑な構造を備えず容易な操作で可能となる。さらに、本発明の医療用材料によれば、体内に残存しても遠隔期の不具合の可能性がほとんどない。 According to the medical material of the present invention, minimally invasive catheter treatment that can be released and indwelled at a treatment site in a living body can be performed by a simple operation without having a complicated structure. Furthermore, according to the medical material of the present invention, even if it remains in the body, there is almost no possibility of a defect in a remote period.

本発明に係る医療用材料の一例である欠損孔閉鎖材１００の全体図（コイルばね１４０が収縮状態）である。It is an overall view (the coil spring 140 is contracted state) of the defect hole closing material 100 which is an example of the medical material which concerns on this invention. 本発明に係る医療用材料の一例である欠損孔閉鎖材１００の全体図（コイルばね１４０が中間状態）である。It is an overall view (the coil spring 140 is an intermediate state) of the defect hole closing material 100 which is an example of the medical material which concerns on this invention. 本発明に係る医療用材料の一例である欠損孔閉鎖材１００の全体図（コイルばね１４０が伸張状態）である。It is an overall view (coil spring 140 in an extended state) of the defect hole closing material 100 which is an example of the medical material which concerns on this invention. 本発明に係る医療用材料の一例である欠損孔閉鎖材１００の全体図（コイルばね１４０が収縮状態および伸張状態）である。It is an overall view (the coil spring 140 is in a contracted state and the extended state) of the defect hole closing material 100 which is an example of the medical material which concerns on this invention. （Ａ）は図２の欠損孔閉鎖材１００の部分的な側面図であって、（Ｂ）はそのＡ−Ａ断面図である。(A) is a partial side view of the defect hole closing material 100 of FIG. 2, and (B) is a cross-sectional view taken along the line AA. 本発明に係る医療用材料の一例である欠損孔閉鎖材１００を心房中隔欠損症のカテーテル治療に用いる場合の概念図である。It is a conceptual diagram in the case where the defect hole closing material 100 which is an example of the medical material which concerns on this invention is used for the catheter treatment of the atrial septal defect. カテーテル治療の手順を示す図６のＢ部の拡大図（その１）である。It is an enlarged view (the 1) of the part B of FIG. 6 which shows the procedure of catheter treatment. カテーテル治療の手順を示す図６のＢ部の拡大図（その２）である。It is an enlarged view (No. 2) of the part B of FIG. 6 which shows the procedure of catheter treatment. カテーテル治療の手順を示す図６のＢ部の拡大図（その３）である。It is an enlarged view (No. 3) of the part B of FIG. 6 which shows the procedure of catheter treatment. 本発明の変形例に係る医療用材料の一例である欠損孔閉鎖材４００の全体図（コイルばね１４０が収縮状態）である。It is an overall view (the coil spring 140 is in a contracted state) of the defect hole closing material 400 which is an example of the medical material which concerns on the modification of this invention. 本発明の変形例に係る医療用材料の一例である欠損孔閉鎖材４００の全体図（コイルばね１４０が中間状態）である。It is an overall view (the coil spring 140 is an intermediate state) of the defect hole closing material 400 which is an example of the medical material which concerns on the modification of this invention. 図１１の部分拡大図である。It is a partially enlarged view of FIG.

以下、本発明に係る医療用材料を、図面に基づき詳しく説明する。なお、以下においては、本発明に係る医療用材料の一例として、カテーテル治療に用いられる欠損孔閉鎖材について説明するが、その他の開口または通路、たとえば心室中隔欠損、動脈管開存等の心臓のその他の開口、および動静脈瘻等の生体のその他の部位（たとえば胃）の開口または通路の閉鎖にも適している。従って、本発明の実施の形態に係る欠損孔閉鎖材は、心房中隔欠損症の穴を閉鎖するための使用に限定されるものではない。 Hereinafter, the medical material according to the present invention will be described in detail with reference to the drawings. In the following, as an example of the medical material according to the present invention, a defect hole closing material used for catheter treatment will be described, but other openings or passages, for example, a heart such as a ventricular septal defect and patent ductus arteriosus. It is also suitable for other openings in the body, and openings or passage closures in other parts of the body (eg, stomach) such as arteriovenous fistulas. Therefore, the defect hole closing material according to the embodiment of the present invention is not limited to the use for closing the hole of the atrial septal defect.

さらに、以下の実施の形態においては、欠損孔閉鎖材（閉鎖栓）１００の編み目状組織は生体吸収性繊維（線材の一例）を編成したものとして説明するが、本発明はこれに限定されるものではない。生体に形成された欠損孔を閉鎖するカテーテル治療ができる欠損孔閉鎖材であればよく、その編み目状組織は、後述する第１の特徴〜第４の特徴を備え第１の作用〜第４の作用を発現する素材であれば生体吸収性繊維以外の線材で編成されていても構わない。このような線材としては、形態保持性（形状保持性）を備えるためにある程度の硬度を備えることが好ましい。 Further, in the following embodiments, the stitch-like structure of the defect hole closing material (closing plug) 100 will be described as knitting bioabsorbable fibers (an example of a wire rod), but the present invention is limited thereto. It's not a thing. Any material that can be used for catheter treatment to close the defect hole formed in the living body may be used, and the knitted tissue has the first feature to the fourth feature described later and has the first action to the fourth. As long as it is a material that exerts its action, it may be knitted with a wire rod other than the bioabsorbable fiber. It is preferable that such a wire rod has a certain degree of hardness in order to have shape retention (shape retention).

［構成］
図１に本実施の形態に係る欠損孔閉鎖材１００の全体図（コイルばね１４０が収縮状態）を、図２にこの欠損孔閉鎖材１００の全体図（コイルばね１４０が中間状態）を、図３にこの欠損孔閉鎖材１００の全体図（コイルばね１４０が伸張状態）を、図４にこの欠損孔閉鎖材１００の全体図（コイルばね１４０が収縮状態および伸張状態）を、それぞれ示す。なお、図３はこの欠損孔閉鎖材１００の全体がカテーテル３００に収納されている状態を、図４はこの欠損孔閉鎖材１００の半分（第１の筒部１１０側）がカテーテル３００に収納されている状態を、それぞれ示す図である。図３に示すカテーテル３００の内部（内壁３１０により形成される空間）にその全体が収納されている欠損孔閉鎖材１００を、第１の筒部１１０側から第２の筒部１２０をカテーテル３００の開口部３２０から矢示Ｙ方向に押し出すと図４の状態になって、さらに第１の筒部１１０を矢示Ｙ方向に押し出すと図１の状態になる。ここで、図２に示す欠損孔閉鎖材１００の状態は、コイルばね１４０が収縮状態と伸張状態との中間状態であって仮想的な状態である。 [Constitution]
FIG. 1 is an overall view of the defective hole closing material 100 according to the present embodiment (coil spring 140 is in a contracted state), and FIG. 2 is an overall view of the defective hole closing material 100 (coil spring 140 is in an intermediate state). 3 shows an overall view of the defective hole closing material 100 (coil spring 140 is in an extended state), and FIG. 4 shows an overall view of the defective hole closing material 100 (a coil spring 140 is in a contracted state and an extended state). Note that FIG. 3 shows a state in which the entire defect hole closing material 100 is housed in the catheter 300, and FIG. 4 shows a state in which half of the defect hole closing material 100 (on the side of the first tubular portion 110) is stored in the catheter 300. It is a figure which shows each state. The defect hole closing material 100, which is entirely housed inside the catheter 300 shown in FIG. 3 (the space formed by the inner wall 310), is attached to the catheter 300 from the first tubular portion 110 side to the second tubular portion 120. When the opening 320 is pushed out in the Y direction indicated by the arrow, the state shown in FIG. 4 is obtained, and when the first tubular portion 110 is further pushed out in the Y direction indicated by the arrow, the state shown in FIG. 1 is obtained. Here, the state of the defect hole closing material 100 shown in FIG. 2 is an intermediate state between the contracted state and the extended state of the coil spring 140, which is a virtual state.

これらの図に示すように、この欠損孔閉鎖材１００は、大略的には、線材を用いた編み目状組織の筒体により形成され、この筒体の略中央部１３０の筒径が他の部分の筒径より
も小さい形状を備え、略中央部１３０を中心にして欠損孔閉鎖材１００における筒体長手方向の第１の端部１１２側の第１の筒部１１０と他の端部（第２の端部１２２）側の第２の筒部１２０とが形成されている。そして特徴的であるのは、第１の端部１１２の線材１１４と第２の端部１２２の線材１２４とにそれぞれ両端が係合され、第１の端部１１２側から略中央部１３０を介して第２の端部１２２側まで第１の筒部１１０および第２の筒部１２０の内部に通された弾性部材の一例であるコイルばね１４０を備える点である。弾性部材は、コイルばね１４０以外であっても弾性を備えその弾性により後述する作用を発現できる部材であればよく、コイルばね１４０に限定されるものではない。 As shown in these figures, the defect hole closing material 100 is generally formed of a tubular body having a stitch-like structure using a wire rod, and the diameter of the substantially central portion 130 of the tubular body is the other portion. The first tubular portion 110 and the other end portion (the first) on the side of the first end 112 in the longitudinal direction of the tubular body in the defect hole closing member 100, which has a shape smaller than the tubular diameter of A second tubular portion 120 on the end portion 122) side of the 2 is formed. What is characteristic is that both ends are engaged with the wire 114 of the first end 112 and the wire 124 of the second end 122, respectively, from the first end 112 side via the substantially central portion 130. The point is that the coil spring 140, which is an example of the elastic member passed through the inside of the first tubular portion 110 and the second tubular portion 120 up to the second end 122 side, is provided. The elastic member may be a member other than the coil spring 140 as long as it has elasticity and can exhibit the action described later by the elasticity, and is not limited to the coil spring 140.

さらに特徴的であるのは、不織布、スポンジ、フィルムおよびこれらの複合体のいずれかから構成された多孔質層が筒体の内面の３箇所に内面に沿うようにそれぞれ配置されている点である。この多孔質層の材料は限定されるものではないが、欠損孔閉鎖材１００における略中央部１３０以外の他の部分である筒体（第１の筒部１１０および第２の筒部１２０）の筒径が拡張／縮小されることに伴い、その筒体の内面形状に沿って多孔質層の形状が変化できる柔軟性を多孔質層が備える必要がある。 Further characteristic is that porous layers composed of non-woven fabric, sponge, film and any of these complexes are arranged along the inner surface at three locations on the inner surface of the cylinder. .. The material of the porous layer is not limited, but the tubular body (first tubular portion 110 and second tubular portion 120) which is a portion other than the substantially central portion 130 of the defect hole closing material 100. As the cylinder diameter is expanded / reduced, the porous layer needs to have the flexibility to change the shape of the porous layer along the inner surface shape of the cylinder.

さらに詳しくは、第１の筒部１１０の長手方向における略中央部１３０側に第１の多孔質層１６１が、第２の筒部１２０の長手方向における略中央部１３０の反対側に第２の多孔質層１６２が、第１の筒部１１０の長手方向における略中央部１３０の反対側に第３の多孔質層１６３が、それぞれ配置されている。そして、第３の多孔質層１６３は、第１の多孔質層１６１および第２の多孔質層１６２よりも長手方向が短いことを特徴とする。なお、ここでは、第１の多孔質層１６１および第２の多孔質層１６２の長手方向の長さは同じであって、これらをまとめて多孔質層１６０と（以下の説明および図面において）記載する場合がある。 More specifically, the first porous layer 161 is on the substantially central portion 130 side in the longitudinal direction of the first tubular portion 110, and the second porous layer 161 is on the opposite side of the substantially central portion 130 in the longitudinal direction of the second tubular portion 120. The porous layer 162 is arranged, and the third porous layer 163 is arranged on the opposite side of the substantially central portion 130 in the longitudinal direction of the first tubular portion 110. The third porous layer 163 is characterized in that the longitudinal direction is shorter than that of the first porous layer 161 and the second porous layer 162. Here, the lengths of the first porous layer 161 and the second porous layer 162 in the longitudinal direction are the same, and these are collectively referred to as the porous layer 160 (in the following description and drawings). May be done.

さらに、図５（Ａ）に、この欠損孔閉鎖材１００の部分的な側面図を、図５（Ｂ）に図５（Ａ）のＡ−Ａ断面図を、それぞれ示す。なお、図５（Ｂ）は、欠損孔閉鎖材１００（より詳しくは第１の筒部１１０）の断面図であるが、コイルばね１４０の断面および生体吸収性繊維１５０の断面ならびに第１の多孔質層１６１の外観のみを図示して、矢示Ａ方向から視認できる生体吸収性繊維１５０の編み目を図示していない。また、図１〜図５において、コイルばね１４０の存在および生体吸収性繊維１５０の編み目についての理解を容易にするために紙面奥側に配置された生体吸収性繊維１５０については図示していないとともに、欠損孔閉鎖材１００の外観形状についての理解を容易にするためにこの欠損孔閉鎖材１００の外観形状を点線で示している部分がある。さらに、全ての図の中で図２のみが、この欠損孔閉鎖材１００の筒体（第１の筒部１１０および第２の筒部１２０）の内面に沿うように多孔質層（第１の多孔質層１６１、第２の多孔質層１６２および第３の多孔質層１６３）が配置されている状態（すなわち、図２（Ａ）に示すように生体吸収性繊維１５０の紙面奥側にハッチングを施した多孔質層が表されている状態）を示し、その他の図は多孔質層の位置、形状および形状の変化（すなわち、生体吸収性繊維１５０の紙面手前側にハッチングを施した多孔質層が表されている状態であって生体吸収性繊維１５０の外側に多孔質層が存在しているように見える状態）を示しているに過ぎない。 Further, FIG. 5 (A) shows a partial side view of the defect hole closing material 100, and FIG. 5 (B) shows a sectional view taken along the line AA of FIG. 5 (A). Note that FIG. 5B is a cross-sectional view of the defect hole closing material 100 (more specifically, the first tubular portion 110), but the cross section of the coil spring 140, the cross section of the bioabsorbable fiber 150, and the first porous body. Only the appearance of the layer 161 is shown, and the stitches of the bioabsorbable fiber 150 that can be visually recognized from the direction of arrow A are not shown. Further, in FIGS. 1 to 5, the bioabsorbable fiber 150 arranged on the back side of the paper surface in order to facilitate understanding of the existence of the coil spring 140 and the stitches of the bioabsorbable fiber 150 is not shown. In order to facilitate understanding of the external shape of the defective hole closing material 100, there is a portion where the external shape of the defective hole closing material 100 is shown by a dotted line. Further, of all the figures, only FIG. 2 is a porous layer (first tubular portion) along the inner surface of the tubular body (first tubular portion 110 and second tubular portion 120) of the defect hole closing material 100. A state in which the porous layer 161, the second porous layer 162, and the third porous layer 163) are arranged (that is, hatching on the back side of the paper surface of the bioabsorbable fiber 150 as shown in FIG. 2 (A)). The other figure shows the change in the position, shape and shape of the porous layer (that is, the porous layer with hatching on the front side of the paper surface of the bioabsorbable fiber 150). It merely shows a state in which the layer is represented (a state in which the porous layer appears to exist on the outside of the bioabsorbable fiber 150).

これらの図（特に図２）に示すように、この欠損孔閉鎖材１００は、生体吸収性材料を用いた編み目状組織の２つの筒体（第１の筒部１１０および第２の筒部１２０）により形成されており、その形状はこのような２つの筒体から構成される、たとえば砂時計型、８の字型、２連の紡錘型（細長い棒状の真ん中が太く両端が細い紡錘形状物が２つ連続した形状）またはピーナッツ型（２粒の実を内包するピーナッツの殻の外観形状）と呼ばれるような形状を備える。このような形状を備える欠損孔閉鎖材１００は、筒体の略中央部１３０の筒径が他の部分の筒径よりも小さくなるように略中央部１３０が絞られた形状を備える。すなわち、略中央部１３０を中心にして第１の端部１１２側の第１の筒部１１０と第２の端部１２２側の第２の筒部１２０とが形成されている。 As shown in these figures (particularly FIG. 2), the defect hole closing material 100 has two tubular bodies (first tubular portion 110 and second tubular portion 120) of a stitch-like structure using a bioabsorbable material. ), And its shape is composed of two such cylinders, for example, an hourglass type, a figure eight shape, and a double spindle type (a spindle shape with a thick center and thin ends in an elongated rod shape). It has a shape called (two consecutive shapes) or a peanut shape (the appearance shape of a peanut shell containing two fruits). The defect hole closing material 100 having such a shape has a shape in which the substantially central portion 130 is narrowed so that the diameter of the substantially central portion 130 of the tubular body is smaller than the diameter of the other portions. That is, the first tubular portion 110 on the first end 112 side and the second tubular portion 120 on the second end 122 side are formed around the substantially central portion 130.

なお、限定されるものではないが、この欠損孔閉鎖材１００は、略中央部１３０の筒径を他の部分の筒径よりも小さい形状になるように、第１の筒部１１０および第２の筒部１２０が一体的に編まれて、この欠損孔閉鎖材１００の全体形状としては２つの筒体から構
成される砂時計型、８の字型、２連の紡錘型またはピーナッツ型に形成される。
そして、図２（Ｂ）に示す多孔質層の２面図および図２（Ｃ）に示す多孔質層の斜視図から理解できるように、第１の多孔質層１６１、第２の多孔質層１６２および第３の多孔質層１６３（３箇所に設けられる多孔質層）は、このような砂時計型、８の字型、２連の紡錘型またはピーナッツ型の形状に沿った傘形状を備えるものである。ここで記載する傘形状とは、代表的には図２（Ｃ）の斜視図に示される形状を意味する。しかしながら、上述したように多孔質層は柔軟性を備え筒体の形状変化とともに多孔質層の形状も変化するために、図２に示すコイルばね１４０が中間状態の欠損孔閉鎖材１００の筒体（第１の筒部１１０および第２の筒部１２０）の形状に合致する形状が、多孔質層の代表的な形状である傘形状を意味することになる。 Although not limited, the defect hole closing material 100 has a first tubular portion 110 and a second tubular portion 110 so that the tubular diameter of the substantially central portion 130 is smaller than the tubular diameter of the other portion. The tubular portion 120 of the above is integrally knitted, and the overall shape of the defect hole closing material 100 is formed into an hourglass type, a figure eight shape, a double spindle type or a peanut shape composed of two cylinders. To.
Then, as can be understood from the two views of the porous layer shown in FIG. 2 (B) and the perspective view of the porous layer shown in FIG. 2 (C), the first porous layer 161 and the second porous layer The 162 and the third porous layer 163 (porous layers provided at three locations) have an umbrella shape that follows such an hourglass shape, a figure eight shape, a double spindle shape, or a peanut shape. Is. The umbrella shape described here typically means the shape shown in the perspective view of FIG. 2 (C). However, as described above, since the porous layer has flexibility and the shape of the porous layer changes as the shape of the tubular body changes, the tubular body of the defect hole closing material 100 in which the coil spring 140 shown in FIG. 2 is in an intermediate state. A shape that matches the shape of (the first tubular portion 110 and the second tubular portion 120) means an umbrella shape that is a typical shape of the porous layer.

この場合において、このような砂時計型、８の字型、２連の紡錘型またはピーナッツ型の型枠（３次元型紙）を用いて、その型枠に合わせて１本の生体吸収性繊維１５０を編成することによりこの欠損孔閉鎖材１００の全体形状が形成される。さらに、限定されるものではないが、この欠損孔閉鎖材１００は、第１の筒部１１０および第２の筒部１２０が一体的に編まれて略同一径の筒体を編成した後に、略中央部１３０を縛ること、または／および、熱セットすること等により、略中央部１３０の筒径を他の部分の筒径よりも小さい形状とした後に略中央部１３０の縛りを開放したり熱セットを開放したりして略中央部１３０の筒径をコイルばね１４０の直径よりも大きい略中央部１３０を形成して、この欠損孔閉鎖材１００の全体形状としては２つの筒体から構成される砂時計型、８の字型、２連の紡錘型またはピーナッツ型に形成されるようにしても構わない。そして、詳しくは後述するが、このような形状とすることにより、図３に示すカテーテル３００の内部（内壁３１０により形成される空間）にその全体が収納されている欠損孔閉鎖材１００を、第１の筒部１１０側から第２の筒部１２０をカテーテル３００の開口部３２０から矢示Ｙ方向に押し出すと第２の筒部１２０がカテーテル３００の内壁３１０により形成される空間から開放されて第２の筒部１２０のコイルばね１４０が収縮して図４の状態になって、さらに第１の筒部１１０を矢示Ｙ方向に押し出すと第１の筒部１１０がカテーテル３００の内壁３１０により形成される空間から開放されて第１の筒部１１０のコイルばね１４０が収縮して図１の状態になるという形状の変化を実現させることができる。 In this case, using such an hourglass-shaped, figure-eight-shaped, double-spindle-shaped or peanut-shaped formwork (three-dimensional paper pattern), one bioabsorbable fiber 150 is formed according to the formwork. By knitting, the entire shape of the defect hole closing material 100 is formed. Further, but not limited to, the defect hole closing material 100 is obtained after the first tubular portion 110 and the second tubular portion 120 are integrally knitted to form a tubular body having substantially the same diameter. By binding or / or heat-setting the central portion 130, the cylinder diameter of the substantially central portion 130 is made smaller than the diameter of the other portions, and then the binding of the substantially central portion 130 is released or heat is applied. By opening the set to form a substantially central portion 130 in which the diameter of the substantially central portion 130 is larger than the diameter of the coil spring 140, the overall shape of the defect hole closing material 100 is composed of two cylinders. It may be formed in an hourglass shape, a figure eight shape, a double spindle shape or a peanut shape. Then, as will be described in detail later, by forming such a shape, the defect hole closing material 100 in which the entire catheter 300 is housed inside (the space formed by the inner wall 310) shown in FIG. When the second tubular portion 120 is pushed out from the opening 320 of the catheter 300 in the direction of arrow Y from the tubular portion 110 side of 1, the second tubular portion 120 is released from the space formed by the inner wall 310 of the catheter 300. When the coil spring 140 of the second tubular portion 120 contracts to the state shown in FIG. 4 and the first tubular portion 110 is further pushed out in the Y direction indicated by the arrow, the first tubular portion 110 is formed by the inner wall 310 of the catheter 300. It is possible to realize a change in shape in which the coil spring 140 of the first tubular portion 110 contracts to be in the state shown in FIG. 1 after being released from the space to be formed.

さらに、この欠損孔閉鎖材１００は、その一端が第１の端部１１２に係合され（たとえば第１の端部１１２の線材１１４のループに引っかけられ）、他の端部が第２の端部１２２に係合され（たとえば第２の端部１２２の線材１２４のループに引っかけられ）、第１の端部１１２側から略中央部１３０を介して第２の端部１２２側まで第１の筒部１１０および第２の筒部１２０の内部に通されたコイルばね１４０を備える。なお、ループ状の線材１１４および線材１２４は、生体吸収性繊維１５０で形成されている。 Further, the defect hole closing material 100 has one end engaged with the first end 112 (for example, hooked on the loop of the wire 114 of the first end 112) and the other end with the second end. The first is engaged with the portion 122 (for example, hooked on the loop of the wire rod 124 of the second end portion 122) from the first end portion 112 side to the second end portion 122 side via the substantially central portion 130. A coil spring 140 passed through the inside of the cylinder portion 110 and the second cylinder portion 120 is provided. The loop-shaped wire 114 and the wire 124 are made of bioabsorbable fiber 150.

図１に示すように、このコイルばね１４０が収縮状態であるときに、第１の端部１１２と第２の端部とが略中央部１３０を中心にして接近して、略中央部１３０以外の他の部分である第１の筒部１１０および第２の筒部１２０の筒径が拡張される。特に好ましくは、このコイルばね１４０が収縮状態であるときに、この欠損孔閉鎖材１００により閉鎖される欠損孔に対応した大きさまで、略中央部１３０以外の他の部分である第１の筒部１１０および第２の筒部１２０の筒径が拡張される。そして、このように略中央部１３０以外の他の部分である第１の筒部１１０および第２の筒部１２０の筒径が拡張されることに伴い、第１の多孔質層１６１および第２の多孔質層１６２が、この欠損孔閉鎖材１００により閉鎖される欠損孔に対応した大きさまで拡張される。 As shown in FIG. 1, when the coil spring 140 is in the contracted state, the first end portion 112 and the second end portion approach each other with the substantially central portion 130 as the center, and other than the substantially central portion 130. The cylinder diameters of the first cylinder portion 110 and the second cylinder portion 120, which are other portions, are expanded. Particularly preferably, when the coil spring 140 is in the contracted state, the first tubular portion which is a portion other than the substantially central portion 130 up to a size corresponding to the defect hole closed by the defect hole closing material 100. The cylinder diameters of the 110 and the second cylinder 120 are expanded. Then, as the cylinder diameters of the first tubular portion 110 and the second tubular portion 120, which are other portions other than the substantially central portion 130, are expanded in this way, the first porous layer 161 and the second tubular portion 120 are expanded. The porous layer 162 of the above is expanded to a size corresponding to the defect hole closed by the defect hole closing material 100.

そして、図３に示すように、この欠損孔閉鎖材１００をカテーテル３００に収納すること等により、このコイルばね１４０が伸張状態であるときに、第１の端部１１２と第２の端部１２２とが略中央部１３０を中心にして離隔して、他の部分である第１の筒部１１０および第２の筒部１２０の筒径が縮小される。特に好ましくは、このコイルばね１４０が伸張状態であるときに、この欠損孔閉鎖材１００が収納されるカテーテル３００に対応した大きさまで他の部分である第１の筒部１１０および第２の筒部１２０の筒径が縮小される。そして、このように他の部分である第１の筒部１１０および第２の筒部１２０の筒径
が縮小されることに伴い、第１の多孔質層１６１、第２の多孔質層１６２および第３の多孔質層１６３が、この欠損孔閉鎖材１００が収納されるカテーテル３００に対応した大きさまで縮小される。 Then, as shown in FIG. 3, by accommodating the defect hole closing material 100 in the catheter 300 or the like, when the coil spring 140 is in the extended state, the first end portion 112 and the second end portion 122 are formed. The diameters of the first tubular portion 110 and the second tubular portion 120, which are other portions, are reduced so as to be separated from each other with the central portion 130 as the center. Particularly preferably, when the coil spring 140 is in the extended state, the first tubular portion 110 and the second tubular portion are other portions up to a size corresponding to the catheter 300 in which the defect hole closing material 100 is housed. The cylinder diameter of 120 is reduced. Then, as the cylinder diameters of the first tubular portion 110 and the second tubular portion 120, which are other portions, are reduced in this way, the first porous layer 161 and the second porous layer 162 and the like are formed. The third porous layer 163 is reduced to a size corresponding to the catheter 300 in which the defect hole closing material 100 is housed.

このように略中央部１３０の筒径よりも小さい直径のコイルばね１４０を用いることにより、欠損孔閉鎖材１００における筒体の長手方向の第１の端部１１２と他の端部である第２の端部１２２とを接近させたり離隔させたりすることができる。このコイルばね１４０を収縮状態とすると図１に示すように、第１の端部１１２と第２の端部１２２とが接近して、略中央部１３０の他の部分の筒径（第１の筒部１１０および第２の筒部１２０における胴部分の筒径）が拡張され、このコイルばね１４０を伸張状態とすると図３に示すように、第１の端部１１２と第２の端部１２２とが離隔して、略中央部１３０の他の部分の筒径（第１の筒部１１０および第２の筒部１２０における胴部分の筒径）が縮小される。さらに、図４に示すように、カテーテル３００から第２の筒部１２０を矢示Ｙ方向に押し出すとカテーテル３００の内壁３１０により形状が規制されていた第２の筒部１２０が自由に形状を変化でき、コイルばね１４０の中で第２の筒部１２０に内包された部分だけが収縮して第２の筒部１２０における胴部分の筒径だけが拡張される。そして、さらに、カテーテル３００から第１の筒部１１０を矢示Ｙ方向に押し出すとカテーテル３００の内壁３１０により形状が規制されていた第１の筒部１１０も自由に形状を変化でき、コイルばね１４０の中で第１の筒部１１０に内包された部分も収縮して図１に示すように第１の筒部１１０における胴部分の筒径も拡張される。 By using the coil spring 140 having a diameter smaller than the cylinder diameter of the substantially central portion 130 in this way, the first end portion 112 and the other end portion in the longitudinal direction of the cylinder body in the defect hole closing material 100 are used. Can be brought closer to or separated from the end portion 122 of the. When the coil spring 140 is in the contracted state, as shown in FIG. 1, the first end portion 112 and the second end portion 122 come close to each other, and the cylinder diameter of the other portion of the substantially central portion 130 (first). When the cylinder portion 110 and the cylinder diameter of the body portion in the second cylinder portion 120 are expanded and the coil spring 140 is in the extended state, the first end portion 112 and the second end portion 122 are shown in FIG. The cylinder diameter of the other portion of the substantially central portion 130 (the cylinder diameter of the body portion in the first cylinder portion 110 and the second cylinder portion 120) is reduced. Further, as shown in FIG. 4, when the second tubular portion 120 is pushed out from the catheter 300 in the Y direction indicated by the arrow, the shape of the second tubular portion 120 whose shape is regulated by the inner wall 310 of the catheter 300 freely changes. As a result, only the portion of the coil spring 140 contained in the second tubular portion 120 contracts, and only the tubular diameter of the body portion in the second tubular portion 120 is expanded. Further, when the first tubular portion 110 is pushed out from the catheter 300 in the Y direction indicated by the arrow, the shape of the first tubular portion 110 whose shape is regulated by the inner wall 310 of the catheter 300 can also be freely changed, and the coil spring 140 The portion included in the first tubular portion 110 is also contracted, and the tubular diameter of the body portion in the first tubular portion 110 is also expanded as shown in FIG.

そして、この欠損孔閉鎖材１００においては、不織布、スポンジ、フィルムおよびこれらの複合体のいずれかから構成された多孔質層（第１の多孔質層１６１、第２の多孔質層１６２および第３の多孔質層１６３）が、筒体の内面に配置されている。第１の筒部１１０および第２の筒部１２０は、生体吸収性繊維１５０の織物（目の粗いもの）、編み物、組み紐状織物、または、筒編み状編み物で構成されており、全体が編み目状組織とされている。ここで確認的に記載するが、この編み目状組織は編成により形成される編み物に限定されるものではなく、上述したように網戸のような目の粗い織り組織により網目状組織が形成されるものを含む。すなわち、編み目状と呼ばれる組織であっても網目状と呼ばれる組織であっても構わない。多孔質層（第１の多孔質層１６１、第２の多孔質層１６２および第３の多孔質層１６３）は、薬剤を塗布、含浸、埋め込みなどで保持させることを想定して、不織布、スポンジ、フィルム、または、これらの複合体のいずれかで構成されている。さらに、この多孔質層（第１の多孔質層１６１、第２の多孔質層１６２および第３の多孔質層１６３）は、生体吸収性材料に限定されるものではなく、生体に吸収されない材料であっても構わない。さらに、多孔質層（第１の多孔質層１６１、第２の多孔質層１６２および第３の多孔質層１６３）は、上述したように柔軟性を備えるために、略中央部１３０以外の他の部分である筒体（第１の筒部１１０および第２の筒部１２０）の筒径が拡張／縮小されること伴い、第１の筒部１１０および第２の筒部１２０の内面に配置された多孔質層（第１の多孔質層１６１、第２の多孔質層１６２および第３の多孔質層１６３）も（筒体の形状変化と同じように形状が変化することにより）拡張／縮小されることになる。 Then, in the defect hole closing material 100, the porous layer (first porous layer 161 and second porous layer 162 and third) composed of any of a non-woven fabric, a sponge, a film and a composite thereof The porous layer 163) of the above is arranged on the inner surface of the tubular body. The first tubular portion 110 and the second tubular portion 120 are composed of a woven fabric (coarse) of bioabsorbable fiber 150, a knitted fabric, a braided woven fabric, or a tubular knitted fabric, and the whole is a stitch. It is said to be a woven fabric. As confirmed here, this stitch-like structure is not limited to the knitting formed by knitting, and as described above, the mesh-like structure is formed by a coarse woven structure such as a screen door. including. That is, it may be a structure called a stitch-like structure or a structure called a mesh-like structure. The porous layer (first porous layer 161, second porous layer 162, and third porous layer 163) is a non-woven fabric or sponge, assuming that a chemical is applied, impregnated, embedded, or the like. , Film, or a complex of these. Further, the porous layer (first porous layer 161, second porous layer 162, and third porous layer 163) is not limited to a bioabsorbable material, and is a material that is not absorbed by a living body. It doesn't matter. Further, the porous layer (the first porous layer 161 and the second porous layer 162 and the third porous layer 163) has other than the substantially central portion 130 in order to have flexibility as described above. (1st cylinder 110 and 2nd cylinder 120) are arranged on the inner surface of the first cylinder 110 and the second cylinder 120 as the diameter of the cylinder (first cylinder 110 and second cylinder 120) is expanded / reduced. The resulting porous layers (first porous layer 161, second porous layer 162, and third porous layer 163) are also expanded (by changing the shape in the same manner as the shape of the cylinder). It will be reduced.

このように、基本的にはコイルばね１４０を除いて、第１の筒部１１０、第２の筒部１２０および多孔質層（第１の多孔質層１６１、第２の多孔質層１６２および第３の多孔質層１６３）は全て生体吸収性材料で構成されているために、コイルばね１４０を除く欠損孔閉鎖材１００の全体が生体吸収性を備える。さらに、欠損孔閉鎖材１００の形状が変化することにより欠損孔を閉鎖する治療が行われるわけであるが、欠損孔閉鎖材１００のこのように生体内で形状が変化しても生体内組織を損傷することがないような、素材、編み目形状、繊維組織および繊維断面で欠損孔閉鎖材１００が、多孔質層（第１の多孔質層１６１、第２の多孔質層１６２および第３の多孔質層１６３）を含めて、形成されている。 As described above, basically, except for the coil spring 140, the first tubular portion 110, the second tubular portion 120, and the porous layer (first porous layer 161, second porous layer 162, and second porous layer). Since all of the porous layer 163) of 3 is made of a bioabsorbable material, the entire defect hole closing material 100 excluding the coil spring 140 has bioabsorbability. Further, the treatment for closing the defect hole is performed by changing the shape of the defect hole closing material 100, and even if the shape of the defect hole closing material 100 changes in the living body in this way, the tissue in the living body is treated. The defect hole closing material 100 in the material, the stitch shape, the fibrous structure and the fiber cross section so as not to be damaged is the porous layer (the first porous layer 161 and the second porous layer 162 and the third porous. It is formed including the quality layer 163).

なお、通常、コイルばね１４０は、たとえばニッケル−チタン合金等が用いられ生体吸収性を備えないが、後述するマグネシウムをベースとする合金を用いて生体吸収性を備えるようにしても構わない。コイルばね１４０に、生体吸収性を備える合金を使用するとレ
ントゲン撮像に反応する点で有利であって、生体吸収性を備えない合金を使用すると金属製部材が体内に一生涯残存しないことになるため遠隔期の不具合が懸念されるという問題点を生じない点で有利である。 Normally, the coil spring 140 is made of, for example, a nickel-titanium alloy and does not have bioabsorbability, but a magnesium-based alloy described later may be used to have bioabsorbability. If an alloy having bioabsorbability is used for the coil spring 140, it is advantageous in that it reacts to X-ray imaging, and if an alloy having no bioabsorbability is used, the metal member will not remain in the body for a lifetime. It is advantageous in that it does not cause the problem of concern about problems in the remote period.

第１の筒部１１０および第２の筒部１２０を構成している生体吸収性繊維１５０は、たとえば、ポリグリコール酸、ポリラクチド（Ｄ、Ｌ、ＤＬ体）、ポリカプロラクトン、グリコール酸−ラクチド（Ｄ、Ｌ、ＤＬ体）共重合体、グリコール酸−ε−カプロラクトン共重合体、ラクチド（Ｄ、Ｌ、ＤＬ体）−ε−カプロラクトン共重合体、ポリ（ｐ−ジオキサノン）、グリコール酸−ラクチド（Ｄ、Ｌ、ＤＬ体）−ε−カプロラクトン共重合体等から選択される少なくとも１種とされ、モノフィラメント糸、マルチフィラメント糸、撚糸、組み紐などのいずれかに加工した形態で使用されるが、モノフィラメント糸の形態で使用されるのが好ましい。 The bioabsorbable fiber 150 constituting the first tubular portion 110 and the second tubular portion 120 is, for example, polyglycolic acid, polylactide (D, L, DL polymer), polycaprolactone, glycolic acid-lactide (D). , L, DL polymer), glycolic acid-ε-caprolactone copolymer, lactide (D, L, DL polymer) -ε-caprolactone copolymer, poly (p-dioxanone), glycolic acid-lactide (D) , L, DL form) -ε-caprolactone copolymer, etc. It is considered to be at least one kind, and is used in a form processed into any one of monofilament yarn, multifilament yarn, twisted yarn, braided cord, etc., but monofilament yarn It is preferably used in the form of.

さらに、この生体吸収性繊維１５０の素材は、生分解性合金であっても構わない。このような生分解性合金の一例として、原材料としてマグネシウムをベースとする合金が挙げられる。
生体吸収性繊維１５０の直径は、０．００１ｍｍ〜１．５ｍｍ程度とされ、適用するカテーテル治療に適切な繊維径および種類が選定される。また、生体吸収性繊維１５０の断面は、生体内組織を損傷しないことを条件として、円、楕円、その他の異形（たとえば星形）などのいずれであってもよい。さらに、生体吸収性繊維１５０の表面は、プラズマ放電、電子線処理、コロナ放電、紫外線照射、オゾン処理等により親水化処理してもよい。また、生体吸収性繊維１５０は、Ｘ線不透過材（たとえば、硫酸バリウム、金チップ、白金チップ等）の塗布または含浸処理や、薬剤（たとえば、心房中隔欠損症のカテーテル治療に適した薬剤）の付着処理、コラーゲン、ゼラチン等の天然高分子あるいはポリビニルアルコール、ポリエチレングリコール等の合成高分子でコーティング処理してもよい。 Further, the material of the bioabsorbable fiber 150 may be a biodegradable alloy. An example of such a biodegradable alloy is a magnesium-based alloy as a raw material.
The diameter of the bioabsorbable fiber 150 is about 0.001 mm to 1.5 mm, and the fiber diameter and type suitable for the catheter treatment to be applied are selected. Further, the cross section of the bioabsorbable fiber 150 may be any of a circle, an ellipse, and other irregular shapes (for example, a star shape), provided that the tissue in the living body is not damaged. Further, the surface of the bioabsorbable fiber 150 may be hydrophilized by plasma discharge, electron beam treatment, corona discharge, ultraviolet irradiation, ozone treatment or the like. The bioabsorbable fiber 150 is suitable for coating or impregnating an X-ray opaque material (for example, barium sulfate, gold chip, platinum chip, etc.) or for treating a drug (for example, catheter treatment for atrial septal defect). ) Adhesion treatment, or coating treatment with a natural polymer such as collagen or gelatin or a synthetic polymer such as polyvinyl alcohol or polyethylene glycol may be used.

第１の筒部１１０および第２の筒部１２０は、生体吸収性繊維１５０が、たとえば、モノフィラメント糸として所望される外径のシリコーン製ゴム管（図示省略）の回りに複数（たとえば、８口または１２口）の給糸口をもつ組紐機を用いて組み紐状織物に製作され、または、丸編機（図示省略）で、略同一径の筒体の編み目状組織に編成される。編成後、上記したように、第１の筒部１１０および第２の筒部１２０と同素材の紐により略中央部１３０において絞られて、２つの筒体から構成される砂時計型、８の字型、２連の紡錘型またはピーナッツ型に形成される。第１の筒部１１０および第２の筒部１２０の筒径は、縮径した場合にカテーテルの内径よりも小さく、拡径した場合に心房中隔欠損症のカテーテル治療に好適な大きさを備える。たとえば、拡径した場合の第１の筒部１１０および第２の筒部１２０の筒径は、５ｍｍ〜８０ｍｍ、好ましくは１５ｍｍ〜２５ｍｍ程度である。また、第１の筒部１１０および第２の筒部１２０の長さ、ならびに、欠損孔閉鎖材１００の編み目状組織の密度についても、心房中隔欠損症のカテーテル治療に好適な密度を備える。なお、第１の筒部１１０および第２の筒部１２０の筒径および長さは、同じである必要はなく、心房中隔欠損症のカテーテル治療に好適なように変更すれば良い。 The first tubular portion 110 and the second tubular portion 120 have a plurality of bioabsorbable fibers 150 (for example, eight ports) around a silicone rubber tube (not shown) having an outer diameter desired as, for example, a monofilament yarn. Alternatively, it is manufactured into a braided woven fabric using a braided machine having 12 yarn feeding ports, or is knitted into a knitted structure of a cylinder having substantially the same diameter by a circular knitting machine (not shown). After knitting, as described above, an hourglass type, figure 8 composed of two cylinders, squeezed at substantially the center 130 by a string of the same material as the first cylinder 110 and the second cylinder 120. Formed into a double spindle or peanut shape. The diameters of the first cylinder 110 and the second cylinder 120 are smaller than the inner diameter of the catheter when the diameter is reduced, and have a size suitable for catheter treatment of atrial septal defect when the diameter is expanded. .. For example, when the diameter is expanded, the cylinder diameters of the first cylinder portion 110 and the second cylinder portion 120 are about 5 mm to 80 mm, preferably about 15 mm to 25 mm. Further, the lengths of the first tubular portion 110 and the second tubular portion 120, and the density of the stitch-like tissue of the defect hole closing material 100 are also provided with a density suitable for catheter treatment of atrial septal defect. The diameter and length of the first tubular portion 110 and the second tubular portion 120 do not have to be the same, and may be changed so as to be suitable for catheter treatment of atrial septal defect.

多孔質層（第１の多孔質層１６１、第２の多孔質層１６２および第３の多孔質層１６３）を構成する生体吸収性材料としては特に限定されず、たとえば、ポリグリコール酸、ポリラクチド（Ｄ、Ｌ、ＤＬ体）、ポリカプロラクトン、グリコール酸−ラクチド（Ｄ、Ｌ、ＤＬ体）共重合体、グリコール酸−ε−カプロラクトン共重合体、ラクチド（Ｄ、Ｌ、ＤＬ体）−ε−カプロラクトン共重合体、ポリ（ｐ−ジオキサノン）、グリコール酸−ラクチド（Ｄ、Ｌ、ＤＬ体）−ε−カプロラクトン共重合体等の合成吸収性高分子が挙げられる。これらは単独で用いられてもよく、２種以上が併用されてもよい。なかでも、適度な分解挙動を示すことから、ポリグリコール酸、ラクチド（Ｄ、Ｌ、ＤＬ体）−ε−カプロラクトン共重合体、グリコール酸−ε−カプロラクトン共重合体およびグリコール酸−ラクチド（Ｄ、Ｌ、ＤＬ体）−ε−カプロラクトン共重合体からなる群より選択される少なくとも１種が好適で、不織布、スポンジ、フィルムまたはこれらの複合体のいずれかから構成される。特に、好ましい態様としては、不織布を例示できる。 The bioabsorbable material constituting the porous layer (first porous layer 161, second porous layer 162, and third porous layer 163) is not particularly limited, and for example, polyglycolic acid or polylactide (polyglycolic acid, polylactide). D, L, DL form), polycaprolactone, glycolic acid-lactide (D, L, DL form) copolymer, glycolic acid-ε-caprolactone copolymer, lactide (D, L, DL form) -ε-caprolactone Examples thereof include synthetic absorbent polymers such as copolymers, poly (p-dioxanone), glycolic acid-lactide (D, L, DL) -ε-caprolactone copolymers. These may be used alone or in combination of two or more. Among them, polyglycolic acid, lactide (D, L, DL form) -ε-caprolactone copolymer, glycolic acid-ε-caprolactone copolymer and glycolic acid-lactide (D, At least one selected from the group consisting of L, DL form) -ε-caprolactone copolymer is suitable and is composed of any of non-woven fabric, sponge, film or a composite thereof. In particular, as a preferred embodiment, a non-woven fabric can be exemplified.

さらに、この多孔質層（第１の多孔質層１６１、第２の多孔質層１６２および第３の多孔質層１６３）の素材は、生分解性合金であっても構わない。このような生分解性合金の一例として、原材料としてマグネシウムをベースとする合金が挙げられる。
この多孔質層（第１の多孔質層１６１、第２の多孔質層１６２および第３の多孔質層１６３）が不織布の場合は、親水化処理が施されていてもよい。親水化処理としては特に限定されず、たとえば、プラズマ処理、グロー放電処理、コロナ放電処理、オゾン処理、表面グラフト処理または紫外線照射処理等が挙げられる。なかでも、不織布層の外観を変化させることなく吸水率を飛躍的に向上できることからプラズマ処理が好適である。なお、多孔質層（第１の多孔質層１６１、第２の多孔質層１６２および第３の多孔質層１６３）は、スポンジ層またはフィルム層でもよく、または、不織布とスポンジ層との複合層、不織布とフィルム層との複合層、スポンジ層とフィルム層との複合層、不織布とスポンジ層とフィルム層との複合層、としてもよい。
この多孔質層（第１の多孔質層１６１、第２の多孔質層１６２および第３の多孔質層１６３）には、心房中隔欠損症のカテーテル治療に適した薬剤が保持されるようにすることも好ましい。
以上のように、本実施の形態に係る欠損孔閉鎖材１００は、以下の特徴を備える。 Further, the material of the porous layer (the first porous layer 161 and the second porous layer 162 and the third porous layer 163) may be a biodegradable alloy. An example of such a biodegradable alloy is a magnesium-based alloy as a raw material.
When the porous layer (the first porous layer 161 and the second porous layer 162 and the third porous layer 163) is a non-woven fabric, it may be hydrophilized. The hydrophilization treatment is not particularly limited, and examples thereof include plasma treatment, glow discharge treatment, corona discharge treatment, ozone treatment, surface graft treatment, and ultraviolet irradiation treatment. Among them, plasma treatment is preferable because the water absorption rate can be dramatically improved without changing the appearance of the non-woven fabric layer. The porous layer (first porous layer 161, second porous layer 162, and third porous layer 163) may be a sponge layer or a film layer, or a composite layer of a non-woven fabric and a sponge layer. , A composite layer of a non-woven fabric and a film layer, a composite layer of a sponge layer and a film layer, and a composite layer of a non-woven fabric and a sponge layer and a film layer may be used.
The porous layers (first porous layer 161, second porous layer 162, and third porous layer 163) are such that a drug suitable for catheter treatment of atrial septal defect is held. It is also preferable to do so.
As described above, the defect hole closing material 100 according to the present embodiment has the following features.

（第１の特徴）略中央部１３０において絞られた第１の筒部１１０および第２の筒部１２０から構成される砂時計型、８の字型、２連の紡錘型またはピーナッツ型に形成されている。
（第２の特徴）一端が第１の端部１１２に係合され（第１の端部１１２のループ状の線材１１４に引っかけられ）他端が第２の端部１２２に係合され（第２の端部１２２のループ状の線材１２４に引っかけられ）、第１の端部１１２側から略中央部１３０を介して第２の端部１２２側まで第１の筒部１１０および第２の筒部１２０の内部に通されたコイルばね１４０を備えている。
（第３の特徴）第１の筒部１１０、第２の筒部１２０、コイルばね１４０（ママグネシウムをベースとする合金で形成されている場合）および多孔質層（第１の多孔質層１６１、第２の多孔質層１６２および第３の多孔質層１６３）により構成され、これらの素材は全て生体吸収性材料で構成されている（コイルばね１４０は、必ずしも生体吸収性を備える必要はない）。
（第４の特徴）第１の筒部１１０の長手方向における略中央部１３０側に第１の多孔質層１６１が、第２の筒部１２０の長手方向における略中央部１３０の反対側に第２の多孔質層１６２が、第１の筒部の長手方向における略中央部１３０の反対側に第３の多孔質層１６３が、それぞれ筒体の内面の３箇所にその内面に沿うように配置されており、第３の多孔質層１６３は、第１の多孔質層１６１および第２の多孔質層１６２よりも長手方向が短い。 (First feature) It is formed into an hourglass type, a figure eight shape, a double spindle type or a peanut shape composed of a first tubular portion 110 and a second tubular portion 120 squeezed in a substantially central portion 130. ing.
(Second feature) One end is engaged with the first end 112 (hooked on the loop-shaped wire 114 of the first end 112), and the other end is engaged with the second end 122 (second feature). (Hooked on the loop-shaped wire 124 of the end 122 of 2), the first cylinder 110 and the second cylinder from the first end 112 side to the second end 122 side via the substantially central portion 130. A coil spring 140 passed through the inside of the portion 120 is provided.
(Third feature) First tubular portion 110, second tubular portion 120, coil spring 140 (when formed of an alloy based on magnesium) and a porous layer (first porous layer 161). , The second porous layer 162 and the third porous layer 163), all of which are composed of bioabsorbable materials (the coil spring 140 does not necessarily have to be bioabsorbable). ).
(Fourth Feature) The first porous layer 161 is located on the substantially central portion 130 side in the longitudinal direction of the first tubular portion 110, and the first porous layer 161 is located on the opposite side of the substantially central portion 130 in the longitudinal direction of the second tubular portion 120. The second porous layer 162 is arranged on the opposite side of the substantially central portion 130 in the longitudinal direction of the first tubular portion, and the third porous layer 163 is arranged along the inner surface at three locations on the inner surface of the tubular body. The third porous layer 163 is shorter in the longitudinal direction than the first porous layer 161 and the second porous layer 162.

そして、第１の特徴および第２の特徴により、カテーテル３００に収納されたこの欠損孔閉鎖材１００に対して、カテーテル３００から第２の筒部１２０を押し出すとカテーテル３００の内壁３１０により形状が規制されていた第２の筒部１２０が自由に形状を変化でき、コイルばね１４０の全体のうちの第２の筒部１２０に内包された部分だけが収縮して第２の筒部１２０における胴部分の筒径だけが拡張され、さらに、カテーテル３００から第１の筒部１１０を押し出すとカテーテル３００の内壁３１０により形状が規制されていた第１の筒部１１０も自由に形状を変化でき、コイルばね１４０の全体のうちの第１の筒部１１０に内包された部分も収縮して第１の筒部１１０における胴部分の筒径も拡張される。そして、このように胴部分の筒径が拡張されることに伴い、第１の多孔質層１６１および第２の多孔質層１６２が、この欠損孔閉鎖材１００により閉鎖される欠損孔に対応した大きさまで拡張される。
特に、この欠損孔閉鎖材１００は、以下の作用を発現する点で、心房中隔欠損症のカテーテル治療に適している。 Then, according to the first feature and the second feature, when the second tubular portion 120 is pushed out from the catheter 300 with respect to the defect hole closing material 100 housed in the catheter 300, the shape is restricted by the inner wall 310 of the catheter 300. The shape of the second tubular portion 120 that has been formed can be freely changed, and only the portion contained in the second tubular portion 120 of the entire coil spring 140 contracts and the body portion in the second tubular portion 120. When the first tubular portion 110 is pushed out from the catheter 300, the shape of the first tubular portion 110 whose shape is regulated by the inner wall 310 of the catheter 300 can also be freely changed, and the coil spring. The portion of the entire 140 contained in the first tubular portion 110 is also contracted, and the tubular diameter of the body portion in the first tubular portion 110 is also expanded. Then, as the cylinder diameter of the body portion is expanded in this way, the first porous layer 161 and the second porous layer 162 correspond to the defect holes closed by the defect hole closing material 100. Expanded to size.
In particular, the defect hole closing material 100 is suitable for catheter treatment of atrial septal defect in that it exhibits the following effects.

（第１の作用）コイルばね１４０の全体を伸張させることにより、多孔質層を含めて欠損孔閉鎖材１００の筒径をカテーテル３００の内径よりも細くして、カテーテル３００にセットすることができる。
（第２の作用）カテーテル３００にセットして心房中隔に開いた穴の位置まで送り込まれて、生体内で第１の端部１１２をアプリケータ等で押して第２の筒部１２０をカテーテル３００から生体内へ押し出すと第２の筒部１２０のコイルばね１４０が収縮して第２の筒部１２０における胴部分の筒径が拡張されるとともに、第２の多孔質層１６２が、この欠損孔閉鎖材１００により閉鎖される欠損孔に対応した大きさまで拡張され、さらに第１の端部１１２をアプリケータ等で押して第１の筒部１１０をカテーテル３００から生体内へ押し出すと第１の筒部１１０のコイルばね１４０も収縮して第１の筒部１１０における胴部分の筒径も拡張されるとともに、第１の多孔質層１６１が、この欠損孔閉鎖材１００により閉鎖される欠損孔に対応した大きさまで拡張されて、右心房側に配置された第１の筒部１１０と左心房側に配置された第２の筒部１２０とが略中央部１３０を中心にして接近して、心房中隔に開いた穴を塞ぐことができる。 (First action) By stretching the entire coil spring 140, the cylinder diameter of the defect hole closing material 100 including the porous layer can be made smaller than the inner diameter of the catheter 300 and set in the catheter 300. ..
(Second action) It is set in the catheter 300 and sent to the position of the hole opened in the atrial septum, and the first end 112 is pushed by an applicator or the like in the living body to push the second tubular portion 120 to the catheter 300. When pushed into the living body, the coil spring 140 of the second tubular portion 120 contracts to expand the tubular diameter of the body portion of the second tubular portion 120, and the second porous layer 162 forms the defect hole. It is expanded to a size corresponding to the defect hole closed by the closing material 100, and when the first end 112 is pushed with an applicator or the like and the first cylinder 110 is pushed out from the catheter 300 into the living body, the first cylinder The coil spring 140 of 110 also contracts to expand the cylinder diameter of the body portion in the first cylinder portion 110, and the first porous layer 161 corresponds to the defect hole closed by the defect hole closing material 100. The first tubular portion 110 arranged on the right atrium side and the second tubular portion 120 arranged on the left atrium side approach each other with the central portion 130 as the center, and are in the atrial septum. It can close the holes in the septum.

（第３の作用）この欠損孔閉鎖材１００を構成する素材（コイルばね１４０を除く場合がある）は全て生体吸収性材料であるので、最終的に生体内に吸収されるので遠隔期の不具合の可能性がほとんどなくなる。
（第４の作用）この欠損孔閉鎖材１００が備える第１の多孔質層１６１および第２の多孔質層１６２は、進行方向（矢示Ｙ方向）に向かって先細りしている傘形状を備えるために（進行方向に向かって広がっていないために）、矢示Ｙ方向へ押し出すときの抵抗が少なく、かつ、第３の多孔質層１６３は進行方向（矢示Ｙ方向）に向かって先細りしていない傘形状を備えるもののその長手方向が第１の多孔質層１６１および第２の多孔質層１６２よりも短いので矢示Ｙ方向へ押し出すときの抵抗が少ない。そして、第１の筒部１１０および第２の筒部１２０ならびに第１の多孔質層１６１および第２の多孔質層により心房中隔に開いた穴を確実に塞ぐことができる。さらに、この場合において、第３の多孔質層１６３は、コイルばね１４０を設けることにより形成される欠損孔閉鎖材１００の長手方向に対する垂直断面の略中心における空間（穴）を閉鎖することができる。
このような作用を容易に理解するために、この欠損孔閉鎖材１００を心房中隔欠損症のカテーテル治療に使用した場合について、図６〜図９を参照して説明する。 (Third action) Since all the materials (the coil spring 140 may be excluded) constituting the defect hole closing material 100 are bioabsorbable materials, they are finally absorbed into the living body, which is a problem in a remote period. There is almost no possibility of.
(Fourth Action) The first porous layer 161 and the second porous layer 162 included in the defect hole closing material 100 have an umbrella shape that tapers in the traveling direction (Y direction indicated by an arrow). Therefore (because it does not spread in the direction of travel), there is little resistance when pushing out in the direction of arrow Y, and the third porous layer 163 tapers in the direction of travel (direction of arrow Y). Although it has an unshaped umbrella shape, its longitudinal direction is shorter than that of the first porous layer 161 and the second porous layer 162, so that resistance when extruding in the arrow Y direction is small. Then, the hole opened in the atrial septum can be reliably closed by the first tubular portion 110 and the second tubular portion 120, and the first porous layer 161 and the second porous layer. Further, in this case, the third porous layer 163 can close the space (hole) at the substantially center of the cross section perpendicular to the longitudinal direction of the defect hole closing member 100 formed by providing the coil spring 140. ..
In order to easily understand such an action, a case where the defect hole closing material 100 is used for catheter treatment of atrial septal defect will be described with reference to FIGS. 6 to 9.

［使用態様］
図６にこの欠損孔閉鎖材１００を心房中隔欠損症のカテーテル治療に用いる場合の概念図を、図７〜図９にこのカテーテル治療の手順を示す図６のＢ部の拡大図を、それぞれ示す。なお、以下においては、本実施の形態に係る欠損孔閉鎖材１００の使用態様に特有の事項についてのみ説明し、一般的な事項については、公知の心房中隔欠損症のカテーテル治療と同じ説明であるのでここでの詳細な説明は繰り返さない。 [Usage]
FIG. 6 is a conceptual diagram when the defect hole closing material 100 is used for catheter treatment of atrial septal defect, and FIGS. 7 to 9 are enlarged views of part B of FIG. 6 showing the procedure of this catheter treatment. Shown. In the following, only the matters specific to the usage mode of the defect hole closing material 100 according to the present embodiment will be described, and the general matters will be described in the same manner as the known catheter treatment for atrial septal defect. Since there is, I will not repeat the detailed explanation here.

図６に示すように、人間の心臓２００は、上大静脈および下大静脈に接続され全身から静脈血を受け入れる右心房２１０、肺動脈および三尖弁２６０を介して右心房２１０に接続され肺へ静脈血を送り出す右心室２２０、肺静脈に接続され肺からの動脈血を受け入れる左心房２３０、大動脈および僧帽弁２７０を介して左心房２３０に接続され全身へ動脈血を送り出す左心室２４０の２心房２心室で構成されている。心房中隔欠損症は、右心房２１０と左心房２３０とを隔てる心房中隔２５０に欠損孔２５２が開いているという疾患である。なお、図６においては、理解しやすくするために、カテーテル３００の先端側を仮想線で示して、カテーテル３００に収納された欠損孔閉鎖材１００を実線にて示す。 As shown in FIG. 6, the human heart 200 is connected to the right atrium 210 via the upper and lower aorta and receives venous blood from the whole body, the pulmonary artery and the tricuspid valve 260 to the lung. Two atriums of the right ventricle 220 that pumps venous blood, the left atrium 230 that is connected to the pulmonary vein and receives arterial blood from the lung, and the left ventricle 240 that is connected to the left atrium 230 via the aorta and mitral valve 270 and pumps arterial blood throughout the body. It is composed of ventricles. Atrial septal defect is a disease in which a defect hole 252 is opened in the atrial septum 250 that separates the right atrium 210 and the left atrium 230. In FIG. 6, for easy understanding, the distal end side of the catheter 300 is shown by a virtual line, and the defect hole closing material 100 housed in the catheter 300 is shown by a solid line.

まず、生体外において、欠損孔２５２に対して適切な大きさまで拡張する欠損孔閉鎖材１００の第１の端部１１２と第２の端部１２２とが離隔する方向へ引っ張ってコイルばね１４０の全体を伸張させて多孔質層（第１の多孔質層１６１、第２の多孔質層１６２および第３の多孔質層１６３）を含む欠損孔閉鎖材１００の筒径がカテーテル３００の内径よりも細くして、カテーテル３００にセットする。大腿静脈より欠損孔閉鎖材１００が収納されたカテーテル３００を挿入して（図３参照）、カテーテル３００を矢示Ｘ（１）方向）へ移動させて、右心房２１０側より欠損孔２５２を通して左心房２３０側に欠損孔閉鎖材１００が収納されたカテーテル３００を近づける。 First, in vitro, the entire coil spring 140 is pulled in a direction in which the first end 112 and the second end 122 of the defect closing material 100 that expands to an appropriate size with respect to the defect hole 252 are separated from each other. The tubular diameter of the defect hole closing material 100 including the porous layer (first porous layer 161, second porous layer 162, and third porous layer 163) is smaller than the inner diameter of the catheter 300. Then, it is set in the catheter 300. A catheter 300 containing a defect hole closing material 100 is inserted from the femoral vein (see FIG. 3), the catheter 300 is moved in the direction of arrow X (1)), and the catheter 300 is moved from the right atrium 210 side through the defect hole 252 to the left. The catheter 300 containing the defect hole closing material 100 is brought closer to the atrium 230 side.

図６および図７に示すように、欠損孔閉鎖材１００の略中央部１３０が欠損孔２５２付近に対応するような位置で、欠損孔閉鎖材１００を収納したカテーテル３００を停止させ
る。生体内において、カテーテル３００から第２の筒部１２０をアプリケータ等で矢示Ｙ方向へ押し出すとカテーテル３００の内壁３１０により形状が規制されていた第２の筒部１２０が自由に形状を変化でき、コイルばね１４０の中で第２の筒部１２０に内包された部分だけが収縮して第２の筒部１２０における胴部分の筒径および第２の多孔質層１６２だけが、図８に示すように拡張される。 As shown in FIGS. 6 and 7, the catheter 300 containing the defect hole closing material 100 is stopped at a position such that the substantially central portion 130 of the defect hole closing material 100 corresponds to the vicinity of the defect hole 252. In the living body, when the second tubular portion 120 is pushed out from the catheter 300 in the Y direction indicated by an applicator or the like, the shape of the second tubular portion 120 whose shape is regulated by the inner wall 310 of the catheter 300 can be freely changed. , Only the portion of the coil spring 140 contained in the second tubular portion 120 contracts, and only the tubular diameter of the body portion in the second tubular portion 120 and the second porous layer 162 are shown in FIG. Is extended as

そして、さらに、カテーテル３００から第１の筒部１１０をアプリケータ等で矢示Ｙ方向へ押し出すとカテーテル３００の内壁３１０により形状が規制されていた第１の筒部１１０も自由に形状を変化でき、コイルばね１４０の中で第１の筒部１１０に内包された部分も収縮して第１の筒部１１０における胴部分の筒径ならびに第１の多孔質層１６１および第３の多孔質層１６３も、図９に示すように拡張される。 Further, when the first tubular portion 110 is pushed out from the catheter 300 in the Y direction indicated by an applicator or the like, the shape of the first tubular portion 110 whose shape is regulated by the inner wall 310 of the catheter 300 can also be freely changed. , The portion of the coil spring 140 contained in the first tubular portion 110 also contracts, and the tubular diameter of the body portion in the first tubular portion 110 as well as the first porous layer 161 and the third porous layer 163. Is also extended as shown in FIG.

すなわち、この欠損孔閉鎖材１００をカテーテル３００からアプリケータ等で押し出すと、左心房側に配置された第２の筒部１２０および第２の多孔質層１６２が先に拡張して、次いで右心房側に配置された第１の筒部１１０ならびに第１の多孔質層１６１および第３の多孔質層１６３が後で拡張する。その結果、右心房側に配置された第１の筒部１１０および第２の多孔質層１６２と左心房側に配置された第２の筒部１２０ならびに第１の多孔質層１６１および第３の多孔質層１６３とが略中央部１３０（欠損孔２５２）を中心にして接近するとともに、第１の筒部１１０および第２の多孔質層１６２、第２の筒部１２０ならびに第１の多孔質層１６１および第３の多孔質層１６３が拡張する。最終的には、図９に示すように、第１の筒部１１０および第２の多孔質層１６２と、第２の筒部１２０ならびに第１の多孔質層１６１および第３の多孔質層１６３とにより心房中隔２５０をその両側から挟み込み、欠損孔閉鎖材１００により、心房中隔２５０に開いた欠損孔２５２を塞ぐことができる。さらに、拡張された第３の多孔質層１６３により、コイルばね１４０を設けることにより形成される欠損孔閉鎖材１００の長手方向に対する垂直断面の略中心における空間（穴）を塞ぐことができる。 That is, when the defect hole closing material 100 is extruded from the catheter 300 with an applicator or the like, the second tubular portion 120 and the second porous layer 162 arranged on the left atrium side first expand, and then the right atrium. The first tubular portion 110 and the first porous layer 161 and the third porous layer 163 arranged on the side are expanded later. As a result, the first tubular portion 110 and the second porous layer 162 arranged on the right atrium side, the second tubular portion 120 arranged on the left atrium side, and the first porous layer 161 and the third porous layer 162. The porous layer 163 approaches the substantially central portion 130 (defective hole 252) at the center, and the first tubular portion 110 and the second porous layer 162, the second tubular portion 120, and the first porous portion are approached. Layer 161 and the third porous layer 163 expand. Finally, as shown in FIG. 9, the first tubular portion 110 and the second porous layer 162, the second tubular portion 120, the first porous layer 161 and the third porous layer 163. The atrial septum 250 is sandwiched from both sides thereof, and the defect hole closing material 100 can close the defect hole 252 opened in the atrial septum 250. Further, the expanded third porous layer 163 can close the space (hole) at the substantially center of the cross section perpendicular to the longitudinal direction of the defect hole closing member 100 formed by providing the coil spring 140.

その後、矢示Ｘ（２）方向へカテーテル３００を移動させて、カテーテル３００を生体外に取り出して治療が完了する。これにより、生体内には（正確には欠損孔２５２付近）には、全て生体吸収性材料から構成された欠損孔閉鎖材１００（コイルばね１４０を除く場合がある）が留置される。このように生体内に留置された欠損孔閉鎖材１００の素材は全て生体吸収性材料であるので（コイルばね１４０を除く場合がある）、最終的に生体内に吸収されるので遠隔期の不具合の可能性がほとんどない。 After that, the catheter 300 is moved in the direction of arrow X (2), and the catheter 300 is taken out of the living body to complete the treatment. As a result, a defect hole closing material 100 (may exclude the coil spring 140) made entirely of a bioabsorbable material is placed in the living body (to be exact, in the vicinity of the defect hole 252). Since all the materials of the defect hole closing material 100 placed in the living body in this way are bioabsorbable materials (the coil spring 140 may be excluded), they are finally absorbed in the living body, which causes a defect in a remote period. There is almost no possibility of.

なお、コイルばね１４０を備えない場合には、欠損孔閉鎖材１００を生体内に留置する前に、欠損孔閉鎖材１００の形態を図９に示す形態に固定する必要があり、たとえば、生体吸収性繊維１５０が熱融着性を備えるようにしておいて生体内で生体吸収性繊維１５０を熱セットすることが考えられていた。しかしながら、この欠損孔閉鎖材１００においてはコイルばね１４０により欠損孔閉鎖材１００の形態を図９に示す形態に固定することができるので有利である。 When the coil spring 140 is not provided, it is necessary to fix the form of the defect hole closing material 100 to the form shown in FIG. 9 before placing the defect hole closing material 100 in the living body. For example, bioabsorption It has been considered that the bioabsorbable fiber 150 is heat-set in the living body so that the sex fiber 150 has heat-sealing property. However, the defect hole closing material 100 is advantageous because the form of the defect hole closing material 100 can be fixed to the form shown in FIG. 9 by the coil spring 140.

以上のようにして、本実施の形態に係る欠損孔閉鎖材１００によると、その全てが生体吸収性材料から構成されており（コイルばね１４０を除く場合がある）最終的に体内に吸収されるため、遠隔期の不具合の可能性がほとんどない。また、コイルばね１４０を備えることにより欠損孔閉鎖材１００の筒径が多孔質層とともに容易に変化するので、欠損孔閉鎖材１００の筒径および多孔質層の大きさを細く変化させてカテーテルに容易にセットすることができる。さらに、欠損孔の位置にて、欠損孔閉鎖材１００をカテーテル３００から押し出すだけでコイルばね１４０を備えることにより、欠損孔閉鎖材１００の筒径を多孔質層とともに太くかつ２つの筒体が接近するように容易に変化させることができ、かつ、その形態を容易に固定することができて、心房中隔に開いた欠損孔を塞ぐことができる。特に、コイルばね１４０を設けることにより形成される欠損孔閉鎖材１００の長手方向に対する垂直断面の略中心における空間（穴）を第３の多孔質層１６３により閉鎖することができ、コイルばね１４０のメリット（作用効果）を十分に発現させることができ、かつ、コイルばね１４０を設けたことによるデメリット（欠損孔閉鎖材１００の長手方向に対する垂直断面の略中心における空間（穴））を解消して、心房中隔に開いた欠損孔を確実に塞ぐことができる。 As described above, according to the defect hole closing material 100 according to the present embodiment, all of the defect hole closing material 100 is composed of a bioabsorbable material (the coil spring 140 may be excluded) and is finally absorbed into the body. Therefore, there is almost no possibility of a malfunction in the remote period. Further, since the cylinder diameter of the defect hole closing material 100 easily changes together with the porous layer by providing the coil spring 140, the cylinder diameter of the defect hole closing material 100 and the size of the porous layer are finely changed to form a catheter. It can be set easily. Further, at the position of the defect hole, the coil spring 140 is provided only by pushing the defect hole closing material 100 from the catheter 300, so that the cylinder diameter of the defect hole closing material 100 is thickened together with the porous layer and the two cylinders are close to each other. It can be easily changed to the like, and its morphology can be easily fixed, and the defect hole opened in the atrial septum can be closed. In particular, the space (hole) at the substantially center of the vertical cross section of the defect hole closing material 100 formed by providing the coil spring 140 can be closed by the third porous layer 163, and the coil spring 140 can be closed. The merit (action effect) can be fully exhibited, and the demerit (space (hole) at the substantially center of the cross section perpendicular to the longitudinal direction of the defect hole closing material 100) due to the provision of the coil spring 140 is eliminated. , The defect hole opened in the atrial septum can be reliably closed.

＜変形例＞
以下において、本発明の変形例に係る医療用材料の一例である欠損孔閉鎖材（閉鎖栓）４００について、図１０〜図１２を参照して説明する。なお、本変形例に係る欠損孔閉鎖材４００は、上述した欠損孔閉鎖材１００における弾性部材（コイルばね１４０）の端部が、編み目状組織の筒体（第１の筒部１１０および第２の筒部１２０）の外部に設けられた小筒部であって、操作ワイヤー５００と螺合可能な小筒部と接合されていること以外は、上述した欠損孔閉鎖材１００と同じであるので、上述した説明と重複する部分についてはここでは繰り返さない。 <Modification example>
Hereinafter, the defect hole closing material (closing plug) 400, which is an example of the medical material according to the modified example of the present invention, will be described with reference to FIGS. 10 to 12. In the defect hole closing material 400 according to the present modification, the end portion of the elastic member (coil spring 140) in the defect hole closing material 100 described above is a tubular body having a stitch-like structure (first tubular portion 110 and second tubular portion 110 and second). It is the same as the above-mentioned defect hole closing material 100 except that it is a small cylinder portion provided outside the tubular portion 120) and is joined to the small cylinder portion that can be screwed with the operation wire 500. , The part that overlaps with the above explanation is not repeated here.

図１０に欠損孔閉鎖材４００の全体図（コイルばね１４０が収縮状態）であって図１に対応する図を、図１１に欠損孔閉鎖材４００の全体図（コイルばね１４０が中間状態）であって図２に対応する図を、図１２に図１１の部分拡大図を、それぞれ示す。
これらの図に示すように、コイルばね１４０の両端部１４２は、カテーテル３００の内部に挿入される操作ワイヤー５００の先端部５１０に設けられた雄ネジ部５１２と螺合可能な雌ネジ部４１２を備えた小筒部（より具体的には筒状の金属片４１０）と接合されている。この金属片４１０は、編み目状組織の筒体（第１の筒部１１０および第２の筒部１２０）の外部に設けられる。ここで、コイルばね１４０は、欠損孔閉鎖材１００と同じように、コイルばね１４０の一端が第１の端部１１２に係合され（たとえば第１の端部１１２の線材１１４のループに引っかけられ）、他の端部が第２の端部１２２に係合され（たとえば第２の端部１２２の線材１２４のループに引っかけられ）ている。そして、両端部１４２に金属片４１０が接合されたコイルばね１４０が、第１の端部１１２側から略中央部１３０を介して第２の端部１２２側まで第１の筒部１１０および第２の筒部１２０の内部に通されている。なお、金属以外の材質の小筒部であっても、コイルばね１４０の両端部１４２ではなく一方端のみに金属片４１０が接合されていても、金属片４１０に雄ネジ部が操作ワイヤー５００に雌ネジ部が設けられていても、構わない。 FIG. 10 shows an overall view of the defective hole closing material 400 (the coil spring 140 is in the contracted state) and corresponds to FIG. 1, and FIG. 11 shows an overall view of the defective hole closing material 400 (the coil spring 140 is in the intermediate state). A diagram corresponding to FIG. 2 is shown, and a partially enlarged view of FIG. 11 is shown in FIG. 12, respectively.
As shown in these figures, both ends 142 of the coil spring 140 have a female threaded portion 412 that can be screwed with a male threaded portion 512 provided at the tip end 510 of the operation wire 500 inserted inside the catheter 300. It is joined to the provided small cylinder portion (more specifically, a tubular metal piece 410). The metal piece 410 is provided outside the tubular body of the stitch-like structure (first tubular portion 110 and second tubular portion 120). Here, in the coil spring 140, as in the case of the defect hole closing member 100, one end of the coil spring 140 is engaged with the first end portion 112 (for example, the coil spring 140 is hooked on the loop of the wire rod 114 of the first end portion 112). ), The other end is engaged with the second end 122 (eg, hooked on the loop of the wire 124 of the second end 122). Then, the coil spring 140 in which the metal pieces 410 are joined to both end portions 142 extends from the first end portion 112 side to the second end portion 122 side via the substantially central portion 130 in the first tubular portion 110 and the second. It is passed through the inside of the tubular portion 120 of the above. Even if the small cylinder is made of a material other than metal, even if the metal piece 410 is joined to only one end of the coil spring 140 instead of 142 at both ends, the male screw part is attached to the metal piece 410 to the operation wire 500. A female screw portion may be provided.

そして、上述したように、コイルばね１４０にニッケル−チタン合金が採用され、金属片４１０にステンレスが採用されることを例示できる。このような金属の組合せの場合の接合方法としては、カシメによる接合が例示できる。
以上のような構造を備えた欠損孔閉鎖材４００は、上述した欠損孔閉鎖材１００の使用態様と同じように使用される。特に好ましくは、欠損孔閉鎖材４００においては、コイルばね１４０の両端部１４２と、カテーテル３００の内部に挿入される操作ワイヤー５００の先端部５１０に設けられた雄ネジ部５１２と螺合可能な雌ネジ部４１２を備えた金属片４１０とが接合されているために、以下のように使用することができる。 Then, as described above, it can be exemplified that a nickel-titanium alloy is adopted for the coil spring 140 and stainless steel is adopted for the metal piece 410. As a joining method in the case of such a combination of metals, joining by caulking can be exemplified.
The defect hole closing material 400 having the above structure is used in the same manner as the above-mentioned usage mode of the defect hole closing material 100. Particularly preferably, in the defect hole closing material 400, a female that can be screwed with both end portions 142 of the coil spring 140 and a male screw portion 512 provided at the tip end portion 510 of the operation wire 500 inserted inside the catheter 300. Since it is joined to the metal piece 410 provided with the screw portion 412, it can be used as follows.

図７に示すように、生体外において、欠損孔２５２に対して適切な大きさまで拡張する欠損孔閉鎖材１００の第１の端部１１２と第２の端部１２２とが離隔する方向へ引っ張ってコイルばね１４０の全体を伸張させて欠損孔閉鎖材１００の筒径がカテーテル３００の内径よりも細くして、カテーテル３００にセットする。このとき、図７には示されていないが、カテーテル３００の内部に挿入される操作ワイヤー５００の先端部５１０に設けられた雄ネジ部５１２と、コイルばね１４０の両端部１４２に接合された一方の金属片４１０の雌ネジ部４１２とを螺合させる。 As shown in FIG. 7, in vitro, the first end 112 and the second end 122 of the defect closing material 100 that expands to an appropriate size with respect to the defect hole 252 are pulled in a direction in which they are separated from each other. The entire coil spring 140 is stretched so that the cylinder diameter of the defect hole closing material 100 is smaller than the inner diameter of the catheter 300, and the coil spring 140 is set in the catheter 300. At this time, although not shown in FIG. 7, one of the male screw portions 512 provided at the tip portion 510 of the operation wire 500 inserted into the catheter 300 and both end portions 142 of the coil spring 140 are joined. The metal piece 410 is screwed with the female screw portion 412 of the above.

そして、生体内において、図７または図８に示すように、カテーテル３００から第２の筒部１２０または第１の筒部１１０を矢示Ｙ方向へ押し出す。この場合において、操作ワイヤー５００の先端に金属片４１０を介してコイルばね１４０が連結されているために（生体吸収性繊維１５０に対して柔軟性のない金属製部材が接続されているために）、操作ワイヤー５００を生体外から（押出）操作して操作性良く矢示Ｙ方向へ押し出すことができる。 Then, in the living body, as shown in FIG. 7 or 8, the second tubular portion 120 or the first tubular portion 110 is pushed out from the catheter 300 in the Y direction indicated by the arrow. In this case, because the coil spring 140 is connected to the tip of the operation wire 500 via the metal piece 410 (because the inflexible metal member is connected to the bioabsorbable fiber 150). , The operation wire 500 can be (extruded) operated from outside the living body to push it out in the Y direction indicated by the arrow with good operability.

そして、図９に示すように欠損孔閉鎖材４００の第２の筒部１２０における胴部分の筒径も第１の筒部１１０における胴部分の筒径も、拡張される。その後、図９には示されていないが、操作ワイヤー５００を生体外から（回転）操作して、雄ネジ部５１２と雌ネジ部４１２との螺合を開放させる。その後、矢示Ｘ（２）方向へカテーテル３００および操
作ワイヤー５００を移動させて、カテーテル３００および操作ワイヤー５００を生体外に取り出して治療が完了する。 Then, as shown in FIG. 9, both the cylinder diameter of the body portion of the second cylinder portion 120 of the defect hole closing member 400 and the cylinder diameter of the body portion of the first cylinder portion 110 are expanded. After that, although not shown in FIG. 9, the operation wire 500 is operated (rotated) from outside the living body to release the screw between the male screw portion 512 and the female screw portion 412. After that, the catheter 300 and the operation wire 500 are moved in the direction of arrow X (2), and the catheter 300 and the operation wire 500 are taken out of the living body to complete the treatment.

以上のようにして、本変形例に係る欠損孔閉鎖材４００によると、上述した欠損孔閉鎖材１００の操作性をさらに向上させることができる。
なお、今回開示された実施の形態はすべての点で例示であって制限的なものではないと考えられるべきである。本発明の範囲は上記した説明ではなくて特許請求の範囲によって示され、特許請求の範囲と均等の意味および範囲内でのすべての変更が含まれることが意図される。 As described above, according to the defect hole closing material 400 according to the present modification, the operability of the defect hole closing material 100 described above can be further improved.
It should be noted that the embodiments disclosed this time are exemplary in all respects and are not restrictive. The scope of the present invention is shown by the scope of claims rather than the above description, and it is intended to include all modifications within the meaning and scope equivalent to the scope of claims.

本発明は、生体組織に形成された欠損孔を治療するためにカテーテルにセットされる医療用材料に好適であり、治療部位にて放出・留置できて低侵襲の治療が可能で、医療用材料が体内に残存しても遠隔期の不具合の可能性がほとんどない点で、特に好ましい。 The present invention is suitable for a medical material set in a catheter for treating a defect hole formed in a living tissue, can be released and indwelled at a treatment site, can be treated with minimal invasiveness, and is a medical material. It is particularly preferable in that even if it remains in the body, there is almost no possibility of a malfunction in the remote period.

１００、４００ 医療用材料（閉鎖栓）
１１０ 第１の筒部
１１２ 第１の端部
１２０ 第２の筒部
１２２ 第２の端部
１３０ 略中央部
１４０ コイルばね
１５０ 生体吸収性繊維
１６０ 多孔質層（第１の多孔質層１６１、第２の多孔質層１６２）
１６３ 多孔質層（第３の多孔質層）
２００ 心臓
２５０ 心房中隔
２５２ 欠損孔
３００ カテーテル 100, 400 Medical materials (closing plugs)
110 First cylinder 112 First end 120 Second cylinder 122 Second end 130 Approximately central 140 Coil spring 150 Bioabsorbable fiber 160 Porous layer (first porous layer 161, first 2 Porous layer 162)
163 Porous layer (third porous layer)
200 Heart 250 Interatrial Septum 252 Defect Hole 300 Catheter

Claims (7)

線材を用いた編み目状組織の筒体により形成された医療用材料であって、
前記筒体の略中央部の筒径が他の部分の筒径よりも小さい形状を備え、
前記略中央部を中心にして前記医療用材料における筒体長手方向の第１の端部側の第１の筒部と他の端部側の第２の筒部とが形成され、
前記第１の端部の線材と前記第２の端部の線材とにそれぞれ両端が係合され、前記第１の端部側から前記略中央部を介して前記第２の端部側まで前記第１の筒部および前記第２の筒部の内部に通された弾性部材を備え、
不織布、スポンジ、フィルムおよびこれらの複合体のいずれかから構成された多孔質層が前記筒体の内面の３箇所に前記内面に沿うようにそれぞれ配置され、
前記第１の筒部の長手方向における略中央部側に第１の多孔質層が、
前記第２の筒部の長手方向における略中央部の反対側に第２の多孔質層が、
前記第１の筒部の長手方向における略中央部の反対側に第３の多孔質層が、それぞれ配置され、
前記第３の多孔質層は、前記第１の多孔質層および第２の多孔質層よりも長手方向が短いことを特徴とする、医療用材料。 A medical material formed by a tubular body of a mesh-like structure using a wire rod.
It has a shape in which the diameter of the substantially central portion of the cylinder is smaller than the diameter of other portions.
A first tubular portion on the first end side in the longitudinal direction of the tubular body and a second tubular portion on the other end side of the medical material are formed around the substantially central portion.
Both ends are engaged with the wire rod at the first end and the wire rod at the second end, respectively, and the wire from the first end side to the second end side via the substantially central portion. An elastic member passed through the inside of the first tubular portion and the second tubular portion is provided.
Porous layers composed of non-woven fabrics, sponges, films, and composites thereof are arranged at three locations on the inner surface of the tubular body along the inner surface.
The first porous layer is formed on the substantially central side in the longitudinal direction of the first tubular portion.
A second porous layer is formed on the opposite side of the substantially central portion in the longitudinal direction of the second tubular portion.
A third porous layer is arranged on the opposite side of the substantially central portion in the longitudinal direction of the first tubular portion.
The medical material, wherein the third porous layer is shorter in the longitudinal direction than the first porous layer and the second porous layer. 前記形状は、砂時計型、８の字型または２連の紡錘型であって、
前記３箇所に設けられる多孔質層は、前記形状に沿った傘形状を備えることを特徴とする、請求項１に記載の医療用材料。 The shape is an hourglass type, a figure eight shape or a double spindle shape.
The medical material according to claim 1, wherein the porous layers provided at the three locations have an umbrella shape that conforms to the shape. 前記弾性部材が収縮状態であるときに、前記第１の端部と前記第２の端部とが前記略中央部を中心にして接近して、前記医療用材料により閉鎖される欠損孔に対応した大きさまで前記他の部分の筒径が拡張され、
前記他の部分の筒径が拡張することに伴い、前記第１の多孔質層および前記第２の多孔質層が、前記医療用材料により閉鎖される欠損孔に対応した大きさまで拡張されることを特徴とする、請求項１または請求項２に記載の医療用材料。 When the elastic member is in a contracted state, the first end portion and the second end portion approach each other with the substantially central portion as the center, and correspond to a defect hole closed by the medical material. The cylinder diameter of the other part is expanded to the size of the above,
As the cylinder diameter of the other portion expands, the first porous layer and the second porous layer are expanded to a size corresponding to the defect hole closed by the medical material. The medical material according to claim 1 or 2, characterized in that. 前記弾性部材が伸張状態であるときに、前記第１の端部と前記第２の端部とが前記略中央部を中心にして離隔して、前記医療用材料が収納されるカテーテルに対応した大きさまで前記他の部分の筒径が縮小され、
前記他の部分の筒径が縮小することに伴い、前記第１の多孔質層、前記第２の多孔質層および前記第３の多孔質層が、前記医療用材料が収納されるカテーテルに対応した大きさまで縮小されることを特徴とする、請求項１または請求項２に記載の医療用材料。 When the elastic member is in the stretched state, the first end portion and the second end portion are separated from each other about the substantially central portion to correspond to a catheter in which the medical material is stored. The cylinder diameter of the other part is reduced to the size,
As the cylinder diameter of the other portion is reduced, the first porous layer, the second porous layer, and the third porous layer correspond to the catheter in which the medical material is housed. The medical material according to claim 1 or 2, wherein the medical material is reduced to the size of the above. 前記弾性部材は、前記略中央部の筒径よりも直径が小さいコイルばねであることを特徴とする、請求項１〜請求項４のいずれかに記載の医療用材料。 The medical material according to any one of claims 1 to 4, wherein the elastic member is a coil spring having a diameter smaller than the cylinder diameter at the substantially central portion. 前記弾性部材の端部は、前記編み目状組織の筒体の外部に設けられた小筒部であって操作ワイヤーと螺合可能な小筒部と接合されていることを特徴とする、請求項１〜請求項４のいずれかに記載の医療用材料。 A claim, wherein the end portion of the elastic member is a small cylinder portion provided outside the tubular body of the stitch-like structure and is joined to a small cylinder portion screwable with an operation wire. The medical material according to any one of 1 to 4. 前記線材または前記多孔質層は、生体吸収性材料であることを特徴とする、請求項１〜請求項４のいずれかに記載の医療用材料。 The medical material according to any one of claims 1 to 4, wherein the wire rod or the porous layer is a bioabsorbable material.
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