JP2006051103A

JP2006051103A - Biological tissue closing implement and biological tissue closing device

Info

Publication number: JP2006051103A
Application number: JP2004233579A
Authority: JP
Inventors: Masakatsu Kawaura; 政克川浦; Tomoji Maruyama; 智司丸山
Original assignee: Terumo Corp
Current assignee: Terumo Corp
Priority date: 2004-08-10
Filing date: 2004-08-10
Publication date: 2006-02-23

Abstract

<P>PROBLEM TO BE SOLVED: To provide a biological tissue closing implement and a biological tissue closing device having high safety which are capable of closing an injury hole formed in a biological tissue membrane easily and securely and stopping bleeding completely. <P>SOLUTION: The biological tissue closing implement 11 comprises a first closing member 2 having an abutting face 211 that abuts the biological tissue membrane and a second closing member 3 connectable to the abutting face 211 side of the first closing member 2. By connecting the second closing member 3 to the first closing member 2 and clamping the biological tissue membrane around the injury hole 900 between the first clamping member 2 and the second clamping member 3, the injury hole 900 is closed. When the first closing member is inserted into a recessed section 32 of the second closing member 3, a projection 22 of the first closing member 2 pushes and opens an umbrella section 34 of the second closing member 3 to expand the diameter. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

本発明は、生体内組織閉鎖具および生体内組織閉鎖装置に関するものである。 The present invention relates to an in vivo tissue closure device and an in vivo tissue closure device.

従来、血管や他の生体内組織中にカテーテル等の診断或いは治療用装置を挿入してなされる低侵襲手術が広く行なわれている。例えば、心臓の冠状動脈の狭窄の治療においては、その治療処置を行なうために血管内へカテーテル等の器具を挿入することが必要になる。 Conventionally, minimally invasive surgery performed by inserting a diagnostic or therapeutic device such as a catheter into a blood vessel or other in vivo tissue has been widely performed. For example, in the treatment of stenosis of the coronary artery of the heart, it is necessary to insert a device such as a catheter into the blood vessel in order to perform the treatment.

このようなカテーテルの血管内への挿入は、通常、大腿部を切開して形成した穿刺孔を介して行なわれる。従って、治療処置が終了した後に、穿刺孔の止血を行なう必要があるが、大腿動脈からの出血時の血圧（出血血圧）は高いため、医療従事者が長時間の間、手指で押さえ続ける（用手圧迫）等の過酷な作業が必要となる。 Such insertion of a catheter into a blood vessel is usually performed through a puncture hole formed by incising the thigh. Therefore, it is necessary to stop hemostasis of the puncture hole after the therapeutic treatment is completed, but since the blood pressure at the time of bleeding from the femoral artery (bleeding blood pressure) is high, the medical worker keeps pressing with fingers for a long time ( Such as manual compression) is required.

近年、このような止血作業を容易かつ確実に行なうために、傷穴から挿入して血管に形成された穴を縫合する縫合装置が開発されている。例えば、装置の端部に籠状に膨らむことのできる部材を設け、縫合の際にこの部材を血管内へ挿入して籠状に膨らませ、その後に縫合用の針を刺し、籠状に膨らんでいる部材を閉じて針をキャッチし、装置の端部を引き抜くものが提案されている（例えば、特許文献１参照）。 In recent years, in order to perform such a hemostasis operation easily and reliably, a suturing device that is inserted through a wound hole and sutures a hole formed in a blood vessel has been developed. For example, a member that can swell in the shape of a hook is provided at the end of the device, and this member is inserted into the blood vessel during suturing, and then swelled in a hook shape. A device has been proposed in which a member is closed, a needle is caught, and an end of the device is pulled out (see, for example, Patent Document 1).

しかしながら、このような構成の縫合装置は、針のキャッチにおける信頼性が低い問題があった。また、縫合用の糸を一旦通した後、その糸の入れ替え作業を行なう必要があるため、縫合に手間と時間がかかるという問題もあった。 However, the suturing device having such a configuration has a problem of low reliability in catching the needle. Further, since it is necessary to perform a thread replacement operation after passing the suture thread once, there is a problem that it takes time and labor for the suture.

一方、生体内組織閉鎖装置として、すでに特許文献２に記載の装置は、硬質のシール部とコラーゲンスポンジとが糸によって連結されている（例えば、特許文献２参照）。 On the other hand, as an in vivo tissue closing device, the device already described in Patent Document 2 has a hard seal portion and a collagen sponge connected by a thread (for example, see Patent Document 2).

特許文献２に記載の装置の操作方法は、まず、本体部の先端を血管の傷穴から挿入して、シール部を展開する。次いで、本体部をゆっくり引き抜きながら、シール部を傷穴およびその周辺組織に当接させる。さらにシール部で傷穴を引っ掛けながら本体部を引くと、本体部の先端からコラーゲンスポンジが傷穴の上の組織中に展開される。そして、本体部を体外に抜去して、シール部とコラーゲンスポンジとに連結した糸を引いて、予め設置されている結び目を進め、シール部とコラーゲンスポンジとを引き寄せて止血を行う。最後に、糸を切断して終了する。 In the operation method of the device described in Patent Document 2, first, the tip of the main body is inserted through a wound hole in a blood vessel, and the seal portion is developed. Next, the seal portion is brought into contact with the wound hole and the surrounding tissue while slowly pulling out the main body portion. Further, when the main body is pulled while catching the wound hole with the seal portion, the collagen sponge is developed from the tip of the main body into the tissue above the wound hole. Then, the main body part is removed from the body, the thread connected to the seal part and the collagen sponge is pulled, the knot set in advance is advanced, and the seal part and the collagen sponge are pulled together to stop bleeding. Finally, cut the yarn and finish.

しかしながら、このような構成の生体内組織閉鎖装置では、傷穴と同程度の径である本体部からコラーゲンスポンジを傷穴へ向って推進されるので、コラーゲンスポンジを血管内へ挿入させてしまうという問題がある。 However, in the in-vivo tissue closing device having such a configuration, the collagen sponge is propelled toward the wound from the main body having the same diameter as the wound, so that the collagen sponge is inserted into the blood vessel. There's a problem.

また、本体部の先端内でコラーゲンスポンジが膨張して本体部から出ない場合があり、また、シール部とコラーゲンスポンジとを糸で締め込むとき、結び目の推進不良が生じることがあり、また、締込み後の糸の切断等の操作が煩雑であるという問題がある。 Also, the collagen sponge may swell in the tip of the main body and may not come out of the main body, and when the seal part and the collagen sponge are tightened with a thread, a knot propulsion failure may occur, There is a problem that operations such as cutting the yarn after tightening are complicated.

さらに、糸の締込みを行うので、止血不良である場合に、再操作およびコラーゲン等の抜去が不可能である。 Furthermore, since the thread is tightened, it is impossible to re-operate and remove collagen or the like when hemostasis is poor.

また、糸が取り付けられた閉鎖要素を血管内に配置し、この糸を通してリングを滑らせ、リングが血管の外側で糸をロックすることで血管の傷穴を閉鎖する装置が提案されている（例えば、特許文献３参照）。 In addition, a device has been proposed in which a closure element with a thread attached is placed in the blood vessel, the ring is slid through this thread, and the ring locks the thread outside the blood vessel to close the wound in the blood vessel ( For example, see Patent Document 3).

特許文献３に開示された装置は、リング（ロッキング部材）を糸に何らかの方法で固定するものであるが、固定の方法が具体的に示されておらず、皮下組織内での固定作業が困難である点と、リングの外径は傷穴に入り得る寸法である必要があるため、小型にならざるを得ず、血管に形成された穴から血管内にリングが落下する可能性があるなどの問題がある。また、閉鎖作業終了後に糸を皮下組織内で切断する操作が必要な点も煩雑である。 The device disclosed in Patent Document 3 is for fixing a ring (locking member) to a thread by some method. However, the fixing method is not specifically shown, and it is difficult to fix in a subcutaneous tissue. Since the outer diameter of the ring needs to be a size that can enter the wound hole, it must be reduced in size, and the ring may fall into the blood vessel from the hole formed in the blood vessel, etc. There is a problem. In addition, it is complicated that an operation of cutting the thread in the subcutaneous tissue after the closing operation is necessary.

特表平８−５０４６１８号公報Japanese National Patent Publication No. 8-504618 特許第２５６２００７号公報Japanese Patent No. 2562007 特許第３１３３０５９号公報Japanese Patent No. 3133059

本発明の目的は、生体内組織膜に形成された傷穴を容易かつ確実に閉じることができて、完全に止血することができるとともに、安全性の高い生体内組織閉鎖具および生体内組織閉鎖装置を提供することにある。 An object of the present invention is to easily and surely close a wound hole formed in a tissue membrane in a living body, to completely stop hemostasis, and to provide a highly safe in-vivo tissue closure device and in-vivo tissue closure. To provide an apparatus.

このような目的は、下記（１）〜（１１）の本発明により達成される。
（１）生体内組織膜を貫通する傷穴を閉じる生体内組織閉鎖具であって、
前記生体内組織膜に当接する当接面を有する第一閉鎖部材と、
前記第一閉鎖部材の前記当接面側に連結可能な第二閉鎖部材とを備え、
前記第一閉鎖部材に前記第二閉鎖部材を連結し、前記第一閉鎖部材と前記第二閉鎖部材との間で前記傷穴の周辺部の前記生体内組織膜を挟むことにより前記傷穴を閉鎖し、
前記第二閉鎖部材は、前記第一閉鎖部材に連結するときに拡径するように構成されていることを特徴とする生体内組織閉鎖具。 Such an object is achieved by the present inventions (1) to (11) below.
(1) An in-vivo tissue closure device for closing a wound penetrating through an in-vivo tissue membrane,
A first closing member having an abutment surface that abuts against the tissue tissue in vivo;
A second closing member connectable to the contact surface side of the first closing member;
The second closure member is connected to the first closure member, and the wound tissue is sandwiched between the first closure member and the second closure member to sandwich the in vivo tissue film around the wound hole. Closed,
The in vivo tissue closure device, wherein the second closing member is configured to expand in diameter when connected to the first closing member.

（２）前記第一閉鎖部材は、前記当接面が形成された本体部と、該本体部の当接面側に突出する突出部とを有し、
前記第二閉鎖部材は、前記突出部が嵌入可能な凹部を有し、
前記第二閉鎖部材の凹部に前記第一閉鎖部材の突出部が嵌入することにより、前記第一閉鎖部材と前記第二閉鎖部材とが連結する上記（１）に記載の生体内組織閉鎖具。 (2) The first closing member has a main body portion on which the abutting surface is formed, and a protruding portion that protrudes toward the abutting surface side of the main body portion,
The second closing member has a recess into which the protrusion can be fitted,
The in-vivo tissue closure device according to (1), wherein the first closing member and the second closing member are connected to each other by fitting the protruding portion of the first closing member into the recess of the second closing member.

（３）前記第一閉鎖部材の突出部は、前記第二閉鎖部材の凹部に嵌入するときに前記第二閉鎖部材を押し広げて拡径させるテーパ面を有する上記（２）に記載の生体内組織閉鎖具。 (3) The in-vivo body according to (2), wherein the protruding portion of the first closing member has a tapered surface that expands the second closing member to expand its diameter when fitted into the recess of the second closing member. Tissue closure.

（４）前記第二閉鎖部材は、前記第一閉鎖部材の突出部が前記凹部に嵌入したときに押し広げられて傘状に開く傘部を有する上記（３）に記載の生体内組織閉鎖具。 (4) The in-vivo tissue closure device according to (3), wherein the second closing member has an umbrella portion that is expanded and opened in an umbrella shape when the protruding portion of the first closing member is fitted into the recess. .

（５）前記傘部には、前記傘部が開いたときに広がる複数のスリットが形成されている上記（４）に記載の生体内組織閉鎖具。 (5) The in-vivo tissue closure device according to (4), wherein the umbrella part is formed with a plurality of slits that expand when the umbrella part is opened.

（６）前記第一閉鎖部材および前記第二閉鎖部材は、生体吸収性材料で構成されている上記（１）ないし（５）のいずれかに記載の生体内組織閉鎖具。 (6) The in-vivo tissue closure device according to any one of (1) to (5), wherein the first closing member and the second closing member are made of a bioabsorbable material.

（７）上記（１）ないし（６）のいずれかに記載の生体内組織閉鎖具を生体内へ配置するための生体内組織閉鎖装置であって、
前記第一閉鎖部材に前記第二閉鎖部材を連結させる操作を行う操作手段を備え、
前記操作手段は、前記第一閉鎖部材を牽引する線状体と、前記第二閉鎖部材を押圧する棒状体とを有し、前記線状体を介して前記第一閉鎖部材を牽引しつつ前記棒状体を介して前記第二閉鎖部材を押圧することにより、前記第一閉鎖部材に前記第二閉鎖部材を連結させることを特徴とする生体内組織閉鎖装置。 (7) An in vivo tissue closure device for placing the in vivo tissue closure device according to any one of (1) to (6) above in a living body,
An operation means for performing an operation of connecting the second closing member to the first closing member;
The operating means includes a linear body that pulls the first closing member, and a rod-shaped body that presses the second closing member, and pulls the first closing member via the linear body An in vivo tissue closing device, wherein the second closing member is connected to the first closing member by pressing the second closing member through a rod-like body.

（８）前記棒状体の先端部に着脱自在に装着された筒状体を有し、使用前の状態で前記筒状体内に前記第一閉鎖部材および前記第二閉鎖部材が保持される上記（７）に記載の生体内組織閉鎖装置。 (8) The above-described (1), wherein the first closure member and the second closure member are held in the tubular body in a state before use. The in-vivo tissue closing device according to 7).

（９）前記傷穴を挿通して留置された管体の内腔に挿入して使用される上記（７）または（８）に記載の生体内組織閉鎖装置。 (9) The in-vivo tissue closure device according to (7) or (8), which is used by being inserted into a lumen of a tubular body that is placed through the wound hole.

（１０）前記管体の内腔に挿入したときの挿入深さを示す指標を有する上記（９）に記載の生体内組織閉鎖装置。 (10) The in-vivo tissue closing device according to (9) above, which has an index indicating an insertion depth when inserted into the lumen of the tubular body.

（１１）前記指標には、前記第一閉鎖部材が前記管体の先端開口から出て、かつ前記第二閉鎖部材が前記管体内にとどまるような挿入深さを示す指標が含まれる上記（１０）に記載の生体内組織閉鎖装置。 (11) The index includes an index indicating an insertion depth such that the first closing member exits from a distal end opening of the tube and the second closing member stays in the tube. In vivo tissue closing device.

本発明によれば、安全性が高く、生体内組織膜に形成された傷穴に対し、止血作業を容易にかつ確実に行なうことができる。すなわち、傷穴を容易にかつ確実に閉じる（閉鎖する）ことができ、完全に止血することができる。 According to the present invention, the safety is high, and hemostasis can be easily and reliably performed on a wound formed in a tissue membrane in a living body. That is, the wound can be easily and reliably closed (closed), and hemostasis can be completely achieved.

以下、本発明の生体内組織閉鎖具および生体内組織閉鎖装置を添付図面に示す好適実施形態に基づいて詳細に説明する。 Hereinafter, the in-vivo tissue closure device and in-vivo tissue closure device of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

図１は、本発明の生体内組織閉鎖具および生体内組織閉鎖装置の実施形態を示す分解斜視図、図２は、図１に示す生体内組織閉鎖具および生体内組織閉鎖装置の縦断面図、図３〜図６は、それぞれ、図１に示す生体内組織閉鎖具および生体内組織閉鎖装置の作用（動作）を説明するための断面図である。 FIG. 1 is an exploded perspective view showing an embodiment of the in-vivo tissue closure device and in-vivo tissue closure device of the present invention, and FIG. 2 is a longitudinal sectional view of the in-vivo tissue closure device and in-vivo tissue closure device shown in FIG. 3 to 6 are cross-sectional views for explaining the operation (operation) of the in-vivo tissue closing device and in-vivo tissue closing device shown in FIG. 1, respectively.

なお、説明の都合上、図１〜図６において、図中の左下側を「先端」、右上側を「基端」として説明する。 For convenience of explanation, in FIGS. 1 to 6, the lower left side in the figure is referred to as “tip” and the upper right side is referred to as “base end”.

これらの図に示す生体内組織閉鎖装置１は、例えば、血管等の生体管腔、生体内部器官、生体内部組織等の生体内組織膜に形成され、経皮的に貫通した傷穴（生体内組織膜を貫通する傷穴）９００を閉じる（閉鎖する）装置である。 The in-vivo tissue closing device 1 shown in these drawings is formed in a living tissue membrane such as a living body lumen such as a blood vessel, a living body internal organ, or a living body internal tissue, and percutaneously penetrates a wound (in vivo A device for closing (closing) 900 a wound through the tissue membrane.

図１に示すように、生体内組織閉鎖装置１は、生体内組織膜に当接する当接面２１１を有する第一閉鎖部材２と該第一閉鎖部材２の当接面２１１側に連結可能な第二閉鎖部材３とからなる生体内組織閉鎖具１１と、第一閉鎖部材２に第二閉鎖部材３を連結させる操作を行うための操作手段４と、円筒状のインサーター（筒状体）５とを備えている。なお、図１中の破線の円の内側は、生体内組織閉鎖具１１の第一閉鎖部材２と第二閉鎖部材３とが連結した状態を示す図である。 As shown in FIG. 1, the in-vivo tissue closing device 1 is connectable to the first closing member 2 having an abutting surface 211 that abuts against the in-vivo tissue membrane and the abutting surface 211 side of the first closing member 2. An in-vivo tissue closure device 11 composed of a second closing member 3, an operating means 4 for performing an operation of connecting the second closing member 3 to the first closing member 2, and a cylindrical inserter (tubular body) And 5. In addition, the inner side of the broken-line circle in FIG. 1 is a diagram illustrating a state in which the first closing member 2 and the second closing member 3 of the in-vivo tissue closing tool 11 are connected.

この生体内組織閉鎖装置１では、第一閉鎖部材２に第二閉鎖部材３を連結し、第一閉鎖部材２と第二閉鎖部材３との間で傷穴９００の周辺部の生体内組織膜を挟むことにより、傷穴９００を閉鎖するものである（図６参照）。すなわち、この生体内組織閉鎖装置１では、最終的に傷穴９００を閉鎖した状態で留置される部材は、第一閉鎖部材２および第二閉鎖部材３、すなわち生体内組織閉鎖具１１である。 In this in-vivo tissue closing device 1, the second closing member 3 is connected to the first closing member 2, and the in-vivo tissue film around the wound 900 is between the first closing member 2 and the second closing member 3. The flaw hole 900 is closed by sandwiching (see FIG. 6). That is, in this in-vivo tissue closing device 1, the members that are indwelled with the wound hole 900 finally closed being the first closing member 2 and the second closing member 3, that is, the in-vivo tissue closing tool 11.

また、生体内組織閉鎖装置１は、傷穴９００を挿通して留置されたシース（管体）９の内腔に、第一閉鎖部材２、第二閉鎖部材３および操作手段４を挿入して使用される。 Further, the in vivo tissue closing device 1 inserts the first closing member 2, the second closing member 3, and the operating means 4 into the lumen of the sheath (tubular body) 9 inserted through the wound hole 900 and placed. used.

シース９は、略円筒状の管体であり、その基端部にハブ９１を有している。このシース９としては、例えば、カテーテルを用いた治療（ＰＣＩ）や診断（ＣＡＧ）の処置後に留置されているシース（イントロデューサシース）を用いてもよく、また、この生体内組織閉鎖装置１専用のものであってもよい。 The sheath 9 is a substantially cylindrical tube body, and has a hub 91 at the base end thereof. As this sheath 9, for example, a sheath (introducer sheath) placed after treatment using a catheter (PCI) or diagnosis (CAG) may be used. It may be.

第一閉鎖部材２は、生体内組織膜の内面に当接するほぼ平らな当接面２１１が形成された本体部２１と、この本体部２１の当接面２１１側に突出する突出部２２とで構成されている。 The first closing member 2 includes a main body portion 21 formed with a substantially flat abutting surface 211 that abuts on the inner surface of a tissue membrane in a living body, and a protruding portion 22 projecting toward the abutting surface 211 side of the main body portion 21. It is configured.

本体部２１は、ほぼ舟形あるいは足形をなしている。突出部２２は、山形ないしは半ラグビーボール形のヘッド部２２１と、細くくびれた首部２２２とで構成されており、全体としてほぼキノコ形をなしている。ヘッド部２２１と本体部２１とが首部２２２により連結されている。また、ヘッド部２２１には、操作手段４の糸４２を挿通する糸挿通孔２３が形成されている。 The main body 21 has a boat shape or a foot shape. The projecting portion 22 is composed of a mountain-shaped or semi-rugby ball-shaped head portion 221 and a narrow neck portion 222, and has a substantially mushroom shape as a whole. The head part 221 and the main body part 21 are connected by a neck part 222. The head portion 221 has a thread insertion hole 23 through which the thread 42 of the operation means 4 is inserted.

第二閉鎖部材３は、ほぼ砲弾形あるいはドングリ形の全体形状をなしている。すなわち、第二閉鎖部材３は、ほぼ円柱状の部材であり、その基端部では外径が基端方向に向かって漸減している。 The second closing member 3 has a generally bullet-shaped or acorn-shaped overall shape. That is, the second closing member 3 is a substantially columnar member, and the outer diameter of the second closing member 3 gradually decreases in the proximal direction at the proximal end portion.

第二閉鎖部材３の中心部には、第二閉鎖部材３の先端面３１に開口する凹部（中空部）３２が形成されている。また、先端面３１から第二閉鎖部材３の軸方向の途中の位置まで、スリット（切れ込み）３３が形成されている。スリット３３は、周方向に沿って好ましくはほぼ等間隔で複数個所（図示の構成では９０°間隔で４箇所）に形成されている。これら複数のスリット３３が形成された第二閉鎖部材３の先端側の部分は、傘部（傘骨部）３４を構成する。 A concave portion (hollow portion) 32 that opens to the distal end surface 31 of the second closing member 3 is formed at the center of the second closing member 3. A slit (cut) 33 is formed from the front end surface 31 to a position in the axial direction of the second closing member 3. The slits 33 are preferably formed at a plurality of locations along the circumferential direction at approximately regular intervals (four locations at 90 ° intervals in the illustrated configuration). A portion on the distal end side of the second closing member 3 in which the plurality of slits 33 are formed constitutes an umbrella portion (umbrella bone portion) 34.

図１中の破線の円内に示すように、第二閉鎖部材３の凹部３２に第一閉鎖部材２の突出部２２が嵌入（嵌合）することにより、第一閉鎖部材２と第二閉鎖部材３とが連結（固定）される。このとき、傘部３４は、突出部２２によって内側から押し広げられ、スリット３３が広がって傘状（傘骨状）に開き、径が拡大する。 As shown in a broken-line circle in FIG. 1, the first closing member 2 and the second closing member 2 are fitted by fitting the protruding portion 22 of the first closing member 2 into the recess 32 of the second closing member 3. The member 3 is connected (fixed). At this time, the umbrella part 34 is pushed and expanded from the inside by the projecting part 22, and the slit 33 widens and opens in an umbrella shape (umbrella bone shape), and the diameter increases.

したがって、第二閉鎖部材３は、シース９の内腔内に配置されて目的部位に到達するまでは小さな寸法になっており、目的部位においてシース９の先端から押し出され、第一閉鎖部材２と連結することによって径が拡大し、皮下組織を圧迫して固定される。そのため、配置後に位置ズレを起こしたり、血管内に落下したりすることはない。 Therefore, the second closing member 3 has a small size until it is disposed in the lumen of the sheath 9 and reaches the target site, and is pushed out from the distal end of the sheath 9 at the target site, By connecting, the diameter is expanded and the subcutaneous tissue is pressed and fixed. For this reason, there is no positional displacement after the placement and no fall into the blood vessel.

第一閉鎖部材２および第二閉鎖部材３は、それぞれ、生体吸収性材料で構成されるのが好ましい。これにより、第一閉鎖部材２および第二閉鎖部材３が所定期間後に生体に吸収され、最終的に生体内に残らないので、人体への影響をなくすことができる。 Each of the first closing member 2 and the second closing member 3 is preferably made of a bioabsorbable material. Thereby, since the 1st closing member 2 and the 2nd closing member 3 are absorbed by the living body after a predetermined period and finally do not remain in the living body, the influence on the human body can be eliminated.

用いられる生体吸収性材料としては、例えば、ポリ乳酸、ポリグリコール酸、ポリジオキサノン等の単体、あるいはこれらの複合体が挙げられる。 Examples of the bioabsorbable material used include simple substances such as polylactic acid, polyglycolic acid, and polydioxanone, or composites thereof.

操作手段４は、横断面形状がほぼ円形の棒状体であるプッシャー４１と、糸４２と、糸留めキャップ（糸保持部材）４３とで構成されている。 The operating means 4 includes a pusher 41 that is a rod-like body having a substantially circular cross section, a thread 42, and a thread retaining cap (thread retaining member) 43.

プッシャー４１の中心部には、糸４２を挿通する糸挿通孔（中空部）４１１が全長に渡り形成されている。また、プッシャー４１の基端付近の外周面には、シース９の内腔に挿入したときの挿入深さを示す指標（目印）４１２が設けられている。 A thread insertion hole (hollow part) 411 through which the thread 42 is inserted is formed in the central part of the pusher 41 over the entire length. Further, an index (mark) 412 indicating an insertion depth when the pusher 41 is inserted into the lumen of the sheath 9 is provided on the outer peripheral surface in the vicinity of the proximal end of the pusher 41.

糸留めキャップ４３は、先細りテーパー形状の先端部４３１を有している。この先端部４３１をプッシャー４１の糸挿通孔４１１の基端開口に挿入し嵌合させることにより、糸４２を挟んで留めることができる。 The thread cap 43 has a tapered end portion 431 that is tapered. By inserting and fitting the distal end portion 431 into the proximal end opening of the thread insertion hole 411 of the pusher 41, the thread 42 can be clamped.

このような生体内組織閉鎖装置１は、使用する際には図２のように組み立てた状態とされる。以下、この組立状態について説明する。 Such an in-vivo tissue closing device 1 is in an assembled state as shown in FIG. 2 when used. Hereinafter, this assembled state will be described.

図２に示すように、組立状態では、プッシャー４１の先端側にインサーター５が接続される。プッシャー４１の外径とインサーター５の内径とは、ほぼ同じになっているので、プッシャー４１の先端部をインサーター５の基端開口内に嵌合させることにより、プッシャー４１の先端側にインサーター５を着脱自在に固定することができる。 As shown in FIG. 2, the inserter 5 is connected to the distal end side of the pusher 41 in the assembled state. Since the outer diameter of the pusher 41 and the inner diameter of the inserter 5 are substantially the same, the distal end of the pusher 41 is fitted into the proximal end opening of the inserter 5 so that The sorter 5 can be detachably fixed.

このインサーター５内に、第一閉鎖部材２および第二閉鎖部材３が先端側からこの順に並んで保持される。このとき、第一閉鎖部材２は、本体部２１の長手方向をインサーター５の軸方向に向けた姿勢とされる。また、第二閉鎖部材３の外径は、インサーター５の内径とほぼ同じかそれより小さくなっており、インサーター５内にほぼ同心的に保持される。 In this inserter 5, the first closing member 2 and the second closing member 3 are held in this order from the tip side. At this time, the first closing member 2 is in a posture in which the longitudinal direction of the main body 21 is directed to the axial direction of the inserter 5. The outer diameter of the second closing member 3 is substantially the same as or smaller than the inner diameter of the inserter 5 and is held substantially concentrically in the inserter 5.

第一閉鎖部材２は、インサーター５内に完全に収納されていてもよいが、図示のように第一閉鎖部材２の一部がインサーター５の先端開口から露出（突出）していてもよい。これにより、シース９内に挿入するとき、より容易に挿入することができる。 The first closing member 2 may be completely stored in the inserter 5, but even if a part of the first closing member 2 is exposed (protruded) from the front end opening of the inserter 5 as shown in the figure. Good. Thereby, when inserting in the sheath 9, it can insert more easily.

糸４２は、プッシャー４１の糸挿通孔４１１と、第二閉鎖部材３の糸挿通孔３５および凹部３２と、第一閉鎖部材２の糸挿通孔２３とに挿通されている。なお、糸挿通孔３５は、第二閉鎖部材３の頂部（基端部）から凹部３２へ貫通するように形成されている。 The thread 42 is inserted into the thread insertion hole 411 of the pusher 41, the thread insertion hole 35 and the recess 32 of the second closing member 3, and the thread insertion hole 23 of the first closing member 2. The thread insertion hole 35 is formed so as to penetrate from the top (base end) of the second closing member 3 to the recess 32.

糸４２の両端部は、プッシャー４１の糸挿通孔４１１の基端開口から外へ出ている。すなわち、糸４２は、第一閉鎖部材２の糸挿通孔２３を通って折り返すように配設されている。糸４２の両端部付近は、糸挿通孔４１１の基端開口に挿入・嵌合された糸留めキャップ４３によって、固定されている。 Both end portions of the thread 42 protrude from the proximal end opening of the thread insertion hole 411 of the pusher 41. That is, the thread 42 is disposed so as to be folded back through the thread insertion hole 23 of the first closing member 2. The vicinity of both ends of the thread 42 is fixed by a thread retaining cap 43 inserted and fitted into the base end opening of the thread insertion hole 411.

このような組立状態では、糸４２の張力により、第一閉鎖部材２および第二閉鎖部材３は、インサーター５内から離脱するのが防止され、インサーター５内に保持される。 In such an assembled state, the first closing member 2 and the second closing member 3 are prevented from being detached from the inserter 5 due to the tension of the thread 42, and are held in the inserter 5.

次に、生体内組織閉鎖装置１を用いて行なう止血作業の手順（生体内組織閉鎖装置１の作用）について説明する。 Next, a procedure of hemostasis work performed using the in vivo tissue closing apparatus 1 (operation of the in vivo tissue closing apparatus 1) will be described.

カテーテルを用いた治療（ＰＣＩ）や診断（ＣＡＧ）の処置後には、穿刺部にシース９が留置されている。このシース９の先端部は、傷穴９００を通って血管内に挿入されている。このシース９の内径は、プッシャー４１の外径とほぼ同じかまたはやや大きくされている。 After treatment (PCI) or diagnosis (CAG) using a catheter, the sheath 9 is placed at the puncture site. The distal end portion of the sheath 9 is inserted into the blood vessel through the wound hole 900. The inner diameter of the sheath 9 is substantially the same as or slightly larger than the outer diameter of the pusher 41.

図３に示すように、このシース９の基端側に、図２に示す組立状態の生体内組織閉鎖装置１をあてがった状態とし、プッシャー４１を先端方向へ前進させる。すると、第一閉鎖部材２、第二閉鎖部材３およびプッシャー４１は、シース９内に挿入されていく。このとき、インサーター５は、シース９の基端に当接することにより、シース９の基端側にとどまり、第一閉鎖部材２、第二閉鎖部材３およびプッシャー４１をシース９内へ案内する。本実施形態では、インサーター５を設けたことにより、第一閉鎖部材２および第二閉鎖部材３をシース９内に極めて円滑かつ容易に挿入することができる。 As shown in FIG. 3, the in-vivo tissue closing device 1 in the assembled state shown in FIG. 2 is applied to the proximal end side of the sheath 9, and the pusher 41 is advanced in the distal direction. Then, the first closing member 2, the second closing member 3, and the pusher 41 are inserted into the sheath 9. At this time, the inserter 5 abuts on the proximal end of the sheath 9, stays on the proximal end side of the sheath 9, and guides the first closing member 2, the second closing member 3, and the pusher 41 into the sheath 9. In the present embodiment, by providing the inserter 5, the first closing member 2 and the second closing member 3 can be inserted into the sheath 9 very smoothly and easily.

さらにプッシャー４１を前進させると、第一閉鎖部材２および第二閉鎖部材３は、プッシャー４１に押圧されてシース９内を前進する。そして、図４に示すように、第一閉鎖部材２がシース９の先端開口から出た位置で、プッシャー４１を停止させる。これにより、第一閉鎖部材２は、血管内で自由になるので、本体部２１の長手方向が血管の長手方向に概ね一致するような姿勢に展開する。 When the pusher 41 is further advanced, the first closing member 2 and the second closing member 3 are pushed by the pusher 41 and advance in the sheath 9. Then, as shown in FIG. 4, the pusher 41 is stopped at the position where the first closing member 2 is out of the distal end opening of the sheath 9. Thereby, since the 1st closure member 2 becomes free within the blood vessel, it expand | deploys to the attitude | position which the longitudinal direction of the main-body part 21 corresponds in general with the longitudinal direction of the blood vessel.

本実施形態では、プッシャー４１に付された指標４１２がインサーター５の基端に一致したときに、第一閉鎖部材２がシース９の先端開口から出て、かつ第二閉鎖部材３がシース９内にとどまるような状態となる。よって、指標４１２を目印としてプッシャー４１の挿入深さを調整することにより、容易に図４に示す状態を得ることができる。なお、プッシャー４１には、図４に示す挿入深さ以外の挿入深さを示す指標がさらに設けられていてもよい。 In the present embodiment, when the index 412 attached to the pusher 41 coincides with the proximal end of the inserter 5, the first closing member 2 comes out from the distal end opening of the sheath 9, and the second closing member 3 is the sheath 9. It will be like staying inside. Therefore, the state shown in FIG. 4 can be easily obtained by adjusting the insertion depth of the pusher 41 with the index 412 as a mark. The pusher 41 may further be provided with an index indicating an insertion depth other than the insertion depth shown in FIG.

図４に示す状態から、糸留めキャップ４３を取り外し、糸４２を基端方向へ引っ張って張力を加えながら、シース９を含む全体を手応えが感じられるまで基端方向へ引っ張る。第一閉鎖部材２の当接面２１１が傷穴９００の周囲の血管壁内面に当接すると、手応えが感じられるので、ここでシース９を基端方向へ引っ張るのを止めることにより、第一閉鎖部材２を傷穴９００の位置に容易に位置決めすることができる。 From the state shown in FIG. 4, the thread retaining cap 43 is removed, and the entire thread including the sheath 9 is pulled in the proximal direction while applying tension by pulling the thread 42 in the proximal direction. When the abutment surface 211 of the first closing member 2 abuts against the inner surface of the blood vessel wall around the wound hole 900, a response is felt, so that the first closure is stopped by stopping the pulling of the sheath 9 in the proximal direction. The member 2 can be easily positioned at the position of the flaw hole 900.

上記のようにして第一閉鎖部材２を傷穴９００に位置決めしたら、糸４２に張力を加えたまま、インサーター５およびシース９を穿刺部位から抜去する。これにより、図５に示す状態となる。 When the first closing member 2 is positioned in the wound hole 900 as described above, the inserter 5 and the sheath 9 are removed from the puncture site while tension is applied to the thread 42. As a result, the state shown in FIG. 5 is obtained.

図５に示す状態から、糸４２に基端方向への張力を加えつつ、プッシャー４１を先端方向へ押圧する。すると、第一閉鎖部材２の突出部２２が糸４２に牽引されて第二閉鎖部材３の凹部３２内に嵌入（嵌合）して、図６に示すように、第一閉鎖部材２と第二閉鎖部材３とが連結、固定される。 From the state shown in FIG. 5, the pusher 41 is pressed in the distal direction while applying a tension in the proximal direction to the thread 42. Then, the protruding portion 22 of the first closing member 2 is pulled by the thread 42 and is fitted (fitted) into the recess 32 of the second closing member 3, and as shown in FIG. The two closing members 3 are connected and fixed.

これにより、第一閉鎖部材２の当接面２１１と第二閉鎖部材３の先端面３１との間に傷穴９００の周辺の血管壁が挟み込まれ、傷穴９００が閉鎖される。その後、プッシャー４１および糸４２をそれぞれ抜去し、止血作業が完了する。 As a result, the blood vessel wall around the wound hole 900 is sandwiched between the contact surface 211 of the first closing member 2 and the distal end surface 31 of the second closing member 3, and the wound hole 900 is closed. Thereafter, the pusher 41 and the thread 42 are respectively removed, and the hemostasis work is completed.

突出部２２のヘッド部２２１の外周面は、第二閉鎖部材３の傘部３４を押し広げて拡径させるテーパ面２４として機能する。すなわち、ヘッド部２２１が凹部３２に嵌入するとき、テーパ面２４が傘部３４の内面に摺動し、傘部３４を内側から押し広げて拡径させる。傘部３４が拡径して先端面３１が広がることにより、傷穴９００の周囲の血管壁をより広い面積で挟むことができるので、より確実な止血が可能となる。 The outer peripheral surface of the head portion 221 of the protruding portion 22 functions as a tapered surface 24 that expands the diameter of the umbrella portion 34 of the second closing member 3 by expanding it. That is, when the head portion 221 is fitted into the recess 32, the tapered surface 24 slides on the inner surface of the umbrella portion 34, and the umbrella portion 34 is expanded from the inside to expand its diameter. By expanding the diameter of the umbrella part 34 and the distal end surface 31, the blood vessel wall around the wound hole 900 can be sandwiched in a wider area, so that more reliable hemostasis is possible.

傘部３４には、ヘッド部２２１に係合する爪３４１が内周側に向かって突出形成されている。凹部３２内に突出部２２（ヘッド部２２１）が一旦嵌入すると、爪３４１がヘッド部２２１に係合することにより、第一閉鎖部材２と第二閉鎖部材３とは確実に連結され、再度分離することはない。よって、第一閉鎖部材２と第二閉鎖部材３が傷穴９００から離脱するのを確実に防止することができ、安全性が高い。 A claw 341 that engages with the head portion 221 is formed on the umbrella portion 34 so as to protrude toward the inner peripheral side. Once the protruding portion 22 (head portion 221) is fitted into the recess 32, the claw 341 engages with the head portion 221, so that the first closing member 2 and the second closing member 3 are securely connected and separated again. Never do. Therefore, it can prevent reliably that the 1st closing member 2 and the 2nd closing member 3 detach | leave from the flaw hole 900, and safety | security is high.

以上説明したように、この生体内組織閉鎖装置１によれば、安全性が高く、血管壁等の生体内組織膜に形成された傷穴９００に対し、止血作業を容易にかつ確実に行なうことができる。すなわち、傷穴９００を容易にかつ確実に閉じる（閉鎖する）ことができ、完全に止血することができる。また、皮下組織内などの深部に配置する際には、径が小さく、挿入し易い。 As described above, according to the in-vivo tissue closing device 1, the safety is high, and the hemostasis operation can be easily and reliably performed on the wound 900 formed in the in-vivo tissue film such as the blood vessel wall. Can do. That is, the wound 900 can be easily and reliably closed (closed), and can be completely hemostatic. Moreover, when arrange | positioning in deep parts, such as in a subcutaneous tissue, a diameter is small and it is easy to insert.

以上、本発明の生体内組織閉鎖具および生体内組織閉鎖装置を図示の実施形態に基づいて説明したが、本発明はこれに限定されるものではなく、各部の構成は、同様の機能を有する任意の構成のものに置換することができる。また、本発明に、他の任意の構成物が付加されていてもよい。 As mentioned above, although the in-vivo tissue closing tool and in-vivo tissue closing device of this invention were demonstrated based on embodiment of illustration, this invention is not limited to this, The structure of each part has the same function. Any configuration can be substituted. In addition, any other component may be added to the present invention.

本発明の生体内組織閉鎖具および生体内組織閉鎖装置の実施形態を示す分解斜視図である。It is a disassembled perspective view which shows embodiment of the in-vivo tissue closure tool and in-vivo tissue closure apparatus of this invention. 図１に示す生体内組織閉鎖具および生体内組織閉鎖装置の縦断面図である。It is a longitudinal cross-sectional view of the in-vivo tissue closing tool and in-vivo tissue closing device shown in FIG. 図１に示す生体内組織閉鎖具および生体内組織閉鎖装置の作用（動作）を説明するための断面図である。It is sectional drawing for demonstrating the effect | action (operation | movement) of the in-vivo tissue closing tool and in-vivo tissue closing device shown in FIG. 図１に示す生体内組織閉鎖具および生体内組織閉鎖装置の作用（動作）を説明するための断面図である。It is sectional drawing for demonstrating the effect | action (operation | movement) of the in-vivo tissue closing tool and in-vivo tissue closing device shown in FIG. 図１に示す生体内組織閉鎖具および生体内組織閉鎖装置の作用（動作）を説明するための断面図である。It is sectional drawing for demonstrating the effect | action (operation | movement) of the in-vivo tissue closing tool and in-vivo tissue closing device shown in FIG. 図１に示す生体内組織閉鎖具および生体内組織閉鎖装置の作用（動作）を説明するための断面図である。It is sectional drawing for demonstrating the effect | action (operation | movement) of the in-vivo tissue closing tool and in-vivo tissue closing device shown in FIG.

符号の説明Explanation of symbols

１生体内組織閉鎖装置
１１生体内組織閉鎖具
２第一閉鎖部材
２１本体部
２１１当接面
２２突出部
２２１ヘッド部
２２２首部
２３糸挿通孔
２４テーパ面
３第二閉鎖部材
３１先端面
３２凹部
３３スリット
３４傘部
３４１爪
３５糸挿通孔
４操作手段
４１プッシャー
４１１糸挿通孔
４１２指標
４２糸
４３糸留めキャップ
４３１先端部
５インサーター
９シース
９１ハブ
９００傷穴
DESCRIPTION OF SYMBOLS 1 Biological tissue closure apparatus 11 Biological tissue closure tool 2 First closing member 21 Main body part 211 Contact surface 22 Protruding part 221 Head part 222 Neck part 23 Thread insertion hole 24 Tapered surface 3 Second closing member 31 Tip surface 32 Recessed part 33 Slit 34 Umbrella 341 Claw 35 Thread insertion hole 4 Operating means 41 Pusher 411 Thread insertion hole 412 Index 42 Thread 43 Thread clamp cap 431 Tip 5 Inserter 9 Sheath 91 Hub 900 Wound hole

Claims

生体内組織膜を貫通する傷穴を閉じる生体内組織閉鎖具であって、
前記生体内組織膜に当接する当接面を有する第一閉鎖部材と、
前記第一閉鎖部材の前記当接面側に連結可能な第二閉鎖部材とを備え、
前記第一閉鎖部材に前記第二閉鎖部材を連結し、前記第一閉鎖部材と前記第二閉鎖部材との間で前記傷穴の周辺部の前記生体内組織膜を挟むことにより前記傷穴を閉鎖し、
前記第二閉鎖部材は、前記第一閉鎖部材に連結するときに拡径するように構成されていることを特徴とする生体内組織閉鎖具。 An in-vivo tissue closure device for closing a wound penetrating in-vivo tissue membrane,
A first closing member having an abutment surface that abuts against the tissue tissue in vivo;
A second closing member connectable to the contact surface side of the first closing member;
The second closure member is connected to the first closure member, and the wound tissue is sandwiched between the first closure member and the second closure member to sandwich the in vivo tissue film around the wound hole. Closed,
The in vivo tissue closure device, wherein the second closing member is configured to expand in diameter when connected to the first closing member.

前記第一閉鎖部材は、前記当接面が形成された本体部と、該本体部の当接面側に突出する突出部とを有し、
前記第二閉鎖部材は、前記突出部が嵌入可能な凹部を有し、
前記第二閉鎖部材の凹部に前記第一閉鎖部材の突出部が嵌入することにより、前記第一閉鎖部材と前記第二閉鎖部材とが連結する請求項１に記載の生体内組織閉鎖具。 The first closing member has a main body portion on which the abutting surface is formed, and a protruding portion that protrudes toward the abutting surface side of the main body portion,
The second closing member has a recess into which the protrusion can be fitted,
The in-vivo tissue closure device according to claim 1, wherein the first closing member and the second closing member are connected to each other by fitting the protruding portion of the first closing member into the recess of the second closing member.

前記第一閉鎖部材の突出部は、前記第二閉鎖部材の凹部に嵌入するときに前記第二閉鎖部材を押し広げて拡径させるテーパ面を有する請求項２に記載の生体内組織閉鎖具。 The in-vivo tissue closure device according to claim 2, wherein the protruding portion of the first closing member has a tapered surface that expands the diameter of the second closing member when the second closing member is inserted into the recess of the second closing member.

前記第二閉鎖部材は、前記第一閉鎖部材の突出部が前記凹部に嵌入したときに押し広げられて傘状に開く傘部を有する請求項３に記載の生体内組織閉鎖具。 The in-vivo tissue closure device according to claim 3, wherein the second closing member has an umbrella portion that is expanded and opened in an umbrella shape when the protruding portion of the first closing member is fitted into the recess.

前記傘部には、前記傘部が開いたときに広がる複数のスリットが形成されている請求項４に記載の生体内組織閉鎖具。 The in vivo tissue closure device according to claim 4, wherein the umbrella part is formed with a plurality of slits that expand when the umbrella part is opened.

前記第一閉鎖部材および前記第二閉鎖部材は、生体吸収性材料で構成されている請求項１ないし５のいずれかに記載の生体内組織閉鎖具。 The in-vivo tissue closure device according to any one of claims 1 to 5, wherein the first closing member and the second closing member are made of a bioabsorbable material.

請求項１ないし６のいずれかに記載の生体内組織閉鎖具を生体内へ配置するための生体内組織閉鎖装置であって、
前記第一閉鎖部材に前記第二閉鎖部材を連結させる操作を行う操作手段を備え、
前記操作手段は、前記第一閉鎖部材を牽引する線状体と、前記第二閉鎖部材を押圧する棒状体とを有し、前記線状体を介して前記第一閉鎖部材を牽引しつつ前記棒状体を介して前記第二閉鎖部材を押圧することにより、前記第一閉鎖部材に前記第二閉鎖部材を連結させることを特徴とする生体内組織閉鎖装置。 An in-vivo tissue closure device for placing the in-vivo tissue closure device according to any one of claims 1 to 6 into a living body,
An operation means for performing an operation of connecting the second closing member to the first closing member;
The operating means includes a linear body that pulls the first closing member, and a rod-shaped body that presses the second closing member, and pulls the first closing member via the linear body An in vivo tissue closing device, wherein the second closing member is connected to the first closing member by pressing the second closing member via a rod-like body.

前記棒状体の先端部に着脱自在に装着された筒状体を有し、使用前の状態で前記筒状体内に前記第一閉鎖部材および前記第二閉鎖部材が保持される請求項７に記載の生体内組織閉鎖装置。 8. The cylinder according to claim 7, further comprising a cylindrical body that is detachably attached to a distal end portion of the rod-shaped body, wherein the first closing member and the second closing member are held in the cylindrical body before use. In vivo tissue closure device.

前記傷穴を挿通して留置された管体の内腔に挿入して使用される請求項７または８に記載の生体内組織閉鎖装置。 The in-vivo tissue closing device according to claim 7 or 8, wherein the in-vivo tissue closing device is used by being inserted into a lumen of a tubular body placed through the wound hole.

前記管体の内腔に挿入したときの挿入深さを示す指標を有する請求項９に記載の生体内組織閉鎖装置。 The in-vivo tissue closure device according to claim 9, further comprising an index indicating an insertion depth when the tube is inserted into the lumen of the tubular body.

前記指標には、前記第一閉鎖部材が前記管体の先端開口から出て、かつ前記第二閉鎖部材が前記管体内にとどまるような挿入深さを示す指標が含まれる請求項１０に記載の生体内組織閉鎖装置。
11. The index according to claim 10, wherein the index includes an index indicating an insertion depth such that the first closing member exits from a distal end opening of the tube and the second closing member stays in the tube. In vivo tissue closure device.