JP2006051103A - Biological tissue closing implement and biological tissue closing device - Google Patents

Biological tissue closing implement and biological tissue closing device Download PDF

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JP2006051103A
JP2006051103A JP2004233579A JP2004233579A JP2006051103A JP 2006051103 A JP2006051103 A JP 2006051103A JP 2004233579 A JP2004233579 A JP 2004233579A JP 2004233579 A JP2004233579 A JP 2004233579A JP 2006051103 A JP2006051103 A JP 2006051103A
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closure member
tissue
member
closure
closing
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Masakatsu Kawaura
Tomoji Maruyama
智司 丸山
政克 川浦
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Terumo Corp
テルモ株式会社
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<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 tissue closure and the tissue closing 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。 Traditionally, minimally invasive surgery is performed by inserting a diagnostic or therapeutic device such as a catheter into a blood vessel or other biological tissue is widely performed. 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。 For example, in the treatment of stenosis of coronary arteries of the heart, it is necessary to insert an instrument such as a catheter into a blood vessel in order to perform its therapeutic action.

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。 Inserted into a blood vessel of such catheters is usually performed through a puncture hole formed by incising the thigh. 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。 Therefore, after the therapeutic treatment is completed, it is necessary to perform hemostasis of puncture, the blood pressure at the time of bleeding from the femoral artery (bleeding blood pressure) is higher, the medical practitioner during the long, continued pressing by a finger ( harsh work of manual compression), or the like 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。 Recently, in order to perform such a hemostatic work easily and reliably, suturing device for suturing a hole is inserted from the wound hole formed in the blood vessels it has been developed. 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)。 For example, a member that can be inflated to cage the end of the device is provided, the member upon the suture is inserted into the blood vessel inflated cage, then put a needle for suturing, bulges cage catch the needle to close the are member, it has been proposed to withdraw the end of the device (for example, see 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。 However, suturing device having such a configuration, reliability of the needle catch there is less problem. 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。 Further, after the threading of the suture once, therefore there replacement work necessary to perform the yarn, labor and time is a problem that according to 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, the tissue closing device, already device described in Patent Document 2, the sealing portion and the collagen sponge rigid are connected by the yarn (e.g., refer to 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。 Operation of the apparatus described in Patent Document 2, first, by inserting the tip of the main body portion from the wound hole of the vessel, to expand the seal. 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。 Then, slowly pull the body portion, to abut the seal portion wound hole and the surrounding tissue. 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。 Further pulling the body portion while hooking wound hole with the sealing portion, collagen sponge from the distal end of the main body portion is deployed into tissue over the wound hole. 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。 Then, withdrawn main body of the body, pulling the strings coupled to the sealing portion and the collagen sponge, advances the knot being pre-installed, hemostasis attract the seal portion and the collagen sponge. 最後に、糸を切断して終了する。 Finally, the end to cut the thread.

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, as in the tissue closing device having such a configuration, since it is propelled towards the main body portion is a diameter comparable to the wound hole collagen sponge to wound hole, thus injects the collagen sponge into a 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。 In addition, there may be cases where the collagen sponge in the distal end of the body portion is not out of the inflated main body portion, also when tightening the seal portion and the collagen sponge with a thread, it may knots propulsion failure occurs, also, operations such as cutting the thread after tightening there is a problem that it is troublesome.

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。 Further, since the tightening of the thread, if it is hemostatic defect, it is impossible to removal, such as re-operation and collagen.

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)。 Moreover, the closure element yarn is attached is disposed in a blood vessel, the yarn slipped ring through, ring device for closing a wound hole in a blood vessel by locking the thread outside the blood vessel has been proposed ( 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。 Disclosed in Patent Document 3 device is ring (locking member) is intended to fix in some way to the yarn, the method of fixation is not specifically indicated, difficult to fixed working in the subcutaneous tissue a point is because the outside diameter of the ring that should be dimensioned to obtain enter the wound hole, inevitably small, the hole formed in the blood vessel into the blood vessel, such as might ring to fall there is a problem. 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。 Also, the operation point necessary to the yarn after the closing operation end cuts within the subcutaneous tissue is complicated.

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

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 able to close a wound hole formed in vivo tissue membranes easily and reliably complete hemostasis it is possible to, more secure tissue closure and the tissue closing 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。 These objects are achieved by the following aspects of the invention (1) to (11).
(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、 (1) A tissue closure for closing a wound hole penetrating an in vivo tissue membrane,
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、 A first closure member having an abutment surface abutting on the in vivo tissue membrane,
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、 And a second closure member connectable to the contact surface side of the first closure member,
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、 Said second closure member connected to the first closure member, the wound hole by sandwiching the in vivo tissue membrane of the peripheral portion of the wound hole between said second closure member and the first closure member closed,
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。 It said second closure member, tissue closure, characterized in that is configured to diameter when connected to the first closure 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、 (2) the first closure member has a main body the abutment surface is formed, and a projection projecting to the contact surface side of the main body portion,
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、 The second closing member, the protrusion has a recess fittable,
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。 The second by the recess of the closure member to the protruding portion of the first closure member is fitted, tissue closure according to the above (1) and said first closure member and said second closure member is connected.

(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 protruding portion of the first closure member, the body according to (2) having a tapered surface which increases in diameter push the said second closure member when fitted into the recess of the second closure member organization 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 second closing member, tissue closure according to (3) having a valve head protruding portion of the first closure member is opened pushed apart by the umbrella-shaped when inserted 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) to said valve head, tissue closure according to (4) in which a plurality of slits are formed extending when the umbrella 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 first closure member and the second closing member, tissue closure according to any one of (1) that consists of bioabsorbable material (5).

(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、 (7) A tissue closing device for placement into the body of the tissue closure according to any one of (1) to (6),
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、 An operation means for performing an operation for coupling the second closing member to the first closure member,
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。 Wherein said operating means comprises a linear body for pulling said first closure member, and a rod-shaped body for pressing the second closure member, while pulling said first closure member through said linear body by pressing the second closure member via a rod-like body, the tissue closing device, characterized in that for coupling the second closing member to the first closure member.

(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) has the rod-shaped body removably mounted cylindrical body the tip of the said first closure member and the second closure member to the tubular body in a state before use is maintained ( 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 tissue closing device according to (7) or (8) which is used by being inserted into the lumen of said wound hole is placed by inserting the tube.

(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 tissue closing device according to (9) having an index indicating the depth of insertion of 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) to said indicator, wherein the first closure member out from the distal end opening of the tubular body, and the said second closure member includes an index indicating the depth of insertion such as remain in the tube body (10 tissue closing device according to).

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。 According to the present invention, high safety, with respect to wound hole formed in vivo tissue membranes, it can be performed easily and reliably hemostasis work. 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。 That is, (closing) easily and reliably closing the wound hole that can can be completely hemostasis.

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 will be described in detail with reference to preferred embodiments illustrating the tissue closure and the tissue closing device of the present invention 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。 Figure 1 is an exploded perspective view showing an embodiment of a tissue closure and the tissue closing device of the present invention, FIG. 2 is a longitudinal sectional view of the tissue closure and the tissue closing device shown in FIG. 1 , 3 to 6 are sectional views for explaining the operation of the tissue closure and the tissue closing device shown in FIG. 1 (operation).

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, "tip" the lower left side in the figure, illustrating the upper right side as "proximal".

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。 Tissue closing device 1 shown in these figures, for example, a biological lumen such as a blood vessel, a living body organs, is formed in vivo tissue membrane such as a living body tissue, percutaneously through the wound hole (in vivo Close wound hole) 900 that penetrates the tissue membrane (closing) a device.

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。 As shown in FIG. 1, the tissue closing device 1, which can be coupled to the contact surface 211 side of the first closure member 2 and said first closure member 2 having a contact surface 211 that contacts the biological tissue membranes a tissue closure 11 consisting of the second closure member 3 which, an operating means 4 for performing an operation of connecting the second closing member 3 in the first closure member 2, a cylindrical inserter (cylindrical body) and a 5. 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。 Incidentally, the inside of the dashed circle in FIG. 1 is a diagram showing a state in which the first closure member 2 of tissue closure 11 and the second closure member 3 has been 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)。 In the tissue closing device 1, the first closure member 2 connecting the second closing member 3, in vivo tissue membrane of the peripheral portion of the wound hole 900 between the first closure member 2 and the second closing member 3 by sandwiching the is for closing the wound hole 900 (see FIG. 6). 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。 That is, in this tissue closing device 1, members to be placed finally wound hole 900 in a state of being closed, the first closure member 2 and the second closing member 3, i.e. a tissue closure 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 tissue closing device 1, in the lumen of the sheath (tube) 9, which is placed by inserting the wound hole 900, the first closure member 2, by inserting the second closing member 3 and the operating means 4 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。 The sheath 9 is a substantially cylindrical tubular body, and has a hub 91 at its proximal end. 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。 As the sheath 9, for example, may be used a sheath is detained after treatment treatment with a catheter (PCI) or diagnosis (CAG) (introducer sheath), also the tissue closing device 1 only it may be of.

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。 A first closure member 2 has a body portion 21 which substantially planar contact surface 211 that abuts the inner surface of the in vivo tissue membrane is formed, the protruding portion 22 protruding to the contact 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。 Body portion 21 has a substantially boat-shaped or footprint. 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。 The projection 22, chevron or the head portion 221 of the semi rugby ball-shaped, is composed of a neck portion 222 hourglass, has a substantially mushroom-shaped as a whole. 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。 It is connected by a head portion 221 and the main body portion 21 Togakubi unit 222. 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。 Further, the head portion 221, the thread insertion hole 23 for inserting the thread 42 of the operating means 4 is formed.

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。 Second closing member 3 has a substantially bullet-shaped or acorn overall shape. 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。 That is, the second closure member 3 is substantially cylindrical member, at its proximal end outside diameter is progressively reduced toward the proximal end.

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。 At the center of the second closing member 3, the recess opening to the distal end surface 31 of the second closing member 3 (the hollow portion) 32 is formed. 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。 Also, from the distal end surface 31 to the position of the middle of the axial direction of the second closing member 3, a slit (notch) 33 is formed. 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。 Slit 33 is (in the illustrated arrangement four positions at 90 ° intervals) a plurality of locations preferably substantially equal intervals along the circumferential direction are formed on. 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。 Distal end portion of the second closure member 3 which the plurality of slits 33 are formed constitutes a bevel portion (umbrella bones) 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。 As shown in the dashed circle in FIG. 1, by the second closure member 3 protruding portion 22 of the first closure member 2 in the recess 32 of fitting (mating), the first closure member 2 and the second closing and the member 3 is connected (fixed). 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。 At this time, the umbrella portion 34 is widened from the inside by the protruding portion 22 opens like an umbrella (umbrella bone shaped) spreads slit 33, the diameter is enlarged.

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。 Thus, the second closure member 3 is disposed within the lumen of the sheath 9 to reach the target site has become a small size is pushed out from the distal end of the sheath 9 at the target site, the first closure member 2 expanded diameter by concatenating is fixed by compressing the subcutaneous tissue. 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, or misaligned after deployment, never or fall into the 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。 The first closure member 2 and the second closing member 3 are each preferably constructed of bioabsorbable materials. 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。 Thus, the first closure member 2 and the second closing member 3 is absorbed in the living body after a predetermined period of time, does not remain in the final in vivo, it is possible to eliminate the influence of the human body.

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。 Bioabsorbable materials used, for example, polylactic acid, polyglycolic acid, a single such 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。 Operating means 4 includes a pusher 41 which is generally circular rod-like member is cross-sectional shape, a yarn 42, and a thread fastening cap (yarn holding 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。 At the center of the pusher 41, the thread insertion hole (hollow portion) 411 for inserting the thread 42 is formed over the entire length. 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。 Further, on the outer peripheral surface near the proximal end of the pusher 41, the index (mark) 412 indicating the depth of insertion of when inserted into the lumen of the sheath 9 is provided.

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。 Thread fastening cap 43 has a tip portion 431 of the tapered tapered. 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。 By the distal end portion 431 fitted and inserted into the proximal end opening of the thread insertion hole 411 of the pusher 41, can be kept across the yarn 42.

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。 Such tissue closing device 1, at the time of use is a state assembled as shown in FIG. 以下、この組立状態について説明する。 The following describes the assembled state.

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。 As shown in FIG. 2, in the assembled state, the inserter 5 is connected to the distal end side of the pusher 41. 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。 The outer diameter and the inner diameter of the inserter 5 of the pusher 41, substantially so are the same, by fitting the distal end portion of the pusher 41 into the proximal end opening of the inserter 5, in the front end side of the pusher 41 it can be removably secured to inserter 5.

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。 This inserter 5, the first closure member 2 and the second closing member 3 is held aligned in that order from the distal end side. 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。 At this time, the first closure member 2 is a posture with its longitudinal direction of the main body portion 21 in the axial direction of the inserter 5. 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。 The outer diameter of the second closing member 3 is smaller than or about the same as the inner diameter of the inserter 5 is substantially concentrically held 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。 The first closure member 2 may be completely accommodated in the inserter 5, a part of the first closure member 2, as shown be exposed from the distal end opening of the inserter 5 (protrusion) good. 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。 Thus, when inserting into the sheath 9 can be more easily inserted.

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。 Yarn 42 includes a thread insertion hole 411 of the pusher 41, the second closing member 3 of the thread insertion hole 35 and the recess 32, is inserted into the first closure member 2 of the thread insertion hole 23. 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。 Note that the thread insertion hole 35 is formed so as to penetrate into the recess 32 from the top of the second closing member 3 (base end).

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。 Both end portions of the thread 42 exits out of the proximal end opening of the thread insertion hole 411 of the pusher 41. 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。 That is, the yarn 42 is arranged to wrap through the first closure member 2 of the thread insertion hole 23. 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。 Near both ends of the thread 42, the thread fastening cap 43 inserted and mated to the proximal end opening of the thread insertion hole 411, is fixed.

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 assembled condition, by the tension of the yarn 42, the first closure member 2 and the second closing member 3 is prevented from being separated from the inserter within 5, it is 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, the procedure of hemostasis work carried out using the tissue closing device 1 (the action of the tissue closing device 1).

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。 After treatment of the treatment with the catheter (PCI) or diagnosis (CAG), the sheath 9 is placed in the puncture. 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。 Distal end of the sheath 9 is inserted through the wound hole 900 into the blood vessel. 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。 The inner diameter of the sheath 9 is substantially equal to or slightly larger 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。 As shown in FIG. 3, the base end of the sheath 9, a state of held against the tissue closing device 1 in an assembled state shown in FIG. 2, to advance the pusher 41 in the distal direction. 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。 Then, the first closure member 2, the second closure member 3 and the pusher 41, will be inserted into the sheath 9. 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。 At this time, the inserter 5, by contacting the proximal end of the sheath 9, remains on the base end side of the sheath 9, to guide the first closure member 2, a second closing member 3 and the pusher 41 into the sheath 9. 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。 In the present embodiment, by providing the inserter 5 it may be very smoothly and easily inserted into the first closure member 2 and the second closing member 3 to the sheath 9.

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。 Further, when advancing the pusher 41, the first closure member 2 and the second closing member 3 is pressed against the pusher 41 advances the sheath 9. 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。 Then, as shown in FIG. 4, at a position where the first closure member 2 has exited the distal opening of the sheath 9, and stops the pusher 41. 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。 Thus, the first closure member 2, since the free intravascularly, expand the position as the longitudinal direction of the main body portion 21 is substantially coincides with the longitudinal direction of the 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。 In the present embodiment, when the indicator 412 attached to the pusher 41 matches the proximal end of the inserter 5, the first closure member 2 is out of the distal opening of the sheath 9, and the second closure member 3 sheath 9 a state, such as stay within. 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。 Therefore, by adjusting the insertion depth of the pusher 41 the indicator 412 as a marker, there can be obtained a state readily shown in Fig. 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。 Incidentally, the pusher 41 may be is further provided an index indicating the depth of insertion of the non-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。 From the state shown in FIG. 4, remove the thread retaining cap 43, while applying tension to pull the yarn 42 in the proximal direction, pulling the whole including the sheath 9 in the proximal direction until tactile feedback is felt. 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。 When contact surface 211 of the first closure member 2 comes into contact with the vessel wall inner surface around the wound hole 900, because tactile feedback is felt, by stopping here pulling the sheath 9 in the proximal direction, the first closure the member 2 can be easily positioned to the position of the wound 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。 After the first closure member 2 as described above is positioned in wound hole 900, while applying tension to the yarn 42, for withdrawing the inserter 5 and the sheath 9 from the puncture site. これにより、図5に示す状態となる。 Thus, a state shown in FIG.

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。 From the state shown in FIG. 5, while applying tension to the proximal direction to the yarn 42, to press the pusher 41 in the distal direction. 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。 Then, the protruding portion 22 of the first closure member 2 is fitted (fitted) into the recess 32 of the second closing member 3, driven by the thread 42, as shown in FIG. 6, the first closure member 2 a two and closure member 3 is connected, it is 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。 Thus, the vessel wall around the wound hole 900 between the abutment surface 211 of the first closure member 2 and the second closure member distal end surface 31 of 3 is sandwiched, wound hole 900 is closed. 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。 Then, the pusher 41 and the yarn 42 withdrawn respectively, hemostatic 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。 The outer peripheral surface of the head portion 221 of the protruding portion 22 functions as a tapered surface 24 which increases in diameter push the second closing member 3 of the valve head 34. 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。 That is, when the head portion 221 is fitted into the recess 32, the tapered surface 24 slides on the inner surface of the valve head 34, is increased in diameter spread the umbrella portion 34 from the inside. 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。 By the umbrella portion 34 is the distal end surface 31 is widened diameter, it is possible to sandwich a wider area of ​​the vessel wall surrounding the wound hole 900, thereby enabling more reliable hemostasis.

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。 The umbrella portion 34, the pawl 341 engages the head portion 221 is protruded toward the inner circumferential side. 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。 When the protruding portion 22 in the recess 32 (the head portion 221) once fitted, by the pawl 341 is engaged with the head portion 221, a first closure member 2 and the second closure member 3 is positively connected, again separated do not be. 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。 Therefore, it is possible to first closure member 2 and the second closing member 3 is reliably prevented from being disengaged from the wound hole 900, high safety.

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。 As described above, according to this tissue closing device 1, high safety, with respect to wound hole 900 formed in vivo tissue membrane such as a blood vessel wall, easily and reliably be performed hemostasis work can. 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。 That is, the wound hole 900 easily and reliably closing (closing) that can, can be completely hemostasis. 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。 Further, when arranging the deep such as subcutaneous tissue, having a small diameter, insertion easy.

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。 Has been described based on the illustrated embodiments tissue closure and the tissue closing device of the present invention, the present invention is not limited to this, each section of the structure has the same function it can be replaced with any configuration. 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。 Further, the present invention may be added other arbitrary structures.

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。 Is an exploded perspective view showing an embodiment of a tissue closure and the tissue closing device of the present 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 sectional view of the tissue closure and the 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 a cross-sectional view for explaining the action (act) in tissue closure and the 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 a cross-sectional view for explaining the action (act) in tissue closure and the 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 a cross-sectional view for explaining the action (act) in tissue closure and the 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 a cross-sectional view for explaining the action (act) in tissue closure and the tissue closing device shown in FIG.

符号の説明 DESCRIPTION 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 1 tissue closing device 11 tissue closure 2 first closure member 21 supports 211 abutment surface 22 protrusions 221 head portion 222 neck 23 yarn insertion hole 24 tapered surface 3 second closing member 31 distal surface 32 recess 33 slit 34 umbrella portion 341 pawl 35 yarn insertion hole 4 operating means 41 the pusher 411 thread passing hole 412 index 42 thread 43 thread retaining cap 431 tip 5 inserter 9 sheath 91 hub 900 wound hole

Claims (11)

  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、 The wound hole penetrating an in vivo tissue membrane closing a tissue closure,
    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、 A first closure member having an abutment surface abutting on the in vivo tissue membrane,
    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、 And a second closure member connectable to the contact surface side of the first closure member,
    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、 Said second closure member connected to the first closure member, the wound hole by sandwiching the in vivo tissue membrane of the peripheral portion of the wound hole between said second closure member and the first closure member closed,
    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。 It said second closure member, tissue closure, characterized in that is configured to diameter when connected to the first closure 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、 It said first closure member has a main body the abutment surface is formed, and a projection projecting to the contact surface side of the main body portion,
    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、 The second closing member, the protrusion has a recess fittable,
    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。 Wherein by the protrusion of the first closure member is fitted in the recess of the second closing member, the tissue closing device according to claim 1, wherein the first closure member and said second closure member is connected.
  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請求項2に記載の生体内組織閉鎖具。 The projecting portion of the first closure member, tissue closure according to claim 2 having a tapered surface which increases in diameter push the said second closure member when fitted into the recess of the second closure member.
  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請求項3に記載の生体内組織閉鎖具。 It said second closure member, tissue closure according to claim 3 having a valve head protruding portion of the first closure member is opened pushed apart by the umbrella-shaped when inserted 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請求項4に記載の生体内組織閉鎖具。 Wherein the valve head, tissue closure according to claim 4 in which a plurality of slits extending when the umbrella is opened is formed.
  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。 It said first closure member and the second closing member, tissue closure according to any one of claims 1 to 5 is composed of a bioabsorbable material.
  7. 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、 The tissue closure according to any one of claims 1 to 6 a tissue closing device for placement into the body,
    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、 An operation means for performing an operation for coupling the second closing member to the first closure member,
    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。 Wherein said operating means comprises a linear body for pulling said first closure member, and a rod-shaped body for pressing the second closure member, while pulling said first closure member through said linear body by pressing the second closure member via a rod-like body, the tissue closing device, characterized in that for coupling the second closing member to the first closure member.
  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請求項7に記載の生体内組織閉鎖装置。 Has a freely-mounted cylindrical member detachably attached to the distal end of the rod-shaped body, according to claim 7, wherein said first closure member and the second closure member to the tubular body in a state before use is maintained the tissue closing device.
  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請求項7または8に記載の生体内組織閉鎖装置。 Tissue closing device according to claim 7 or 8 is used by being inserted into the lumen of been tube placed by inserting 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請求項9に記載の生体内組織閉鎖装置。 Tissue closing device according to claim 9 having the index indicating the depth of insertion of 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請求項10に記載の生体内組織閉鎖装置。 The said indicator, said the first closure member out from the distal end opening of the tubular body, and the second closure member of claim 10 including the indication of the insertion depth, such as remain in the tube body vivo tissue closure devices.
JP2004233579A 2004-08-10 2004-08-10 Biological tissue closing implement and biological tissue closing device Pending JP2006051103A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009136671A (en) * 2007-10-31 2009-06-25 Radi Medical Systems Ab Device for sealing puncture hole in bodily organ
JP2009219857A (en) * 2008-02-21 2009-10-01 Terumo Corp In-vivo tissue closing device
JP2012501754A (en) * 2008-09-04 2012-01-26 キュラシール インコーポレイテッド Expandable device for multiple intestinal fistula treatment

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009136671A (en) * 2007-10-31 2009-06-25 Radi Medical Systems Ab Device for sealing puncture hole in bodily organ
JP2013154230A (en) * 2007-10-31 2013-08-15 Radi Medical Systems Ab Device for sealing puncture hole in bodily organ
US8858591B2 (en) 2007-10-31 2014-10-14 Radi Medical Systems Ab Method and device for sealing a puncture hole in a bodily organ
JP2009219857A (en) * 2008-02-21 2009-10-01 Terumo Corp In-vivo tissue closing device
JP2012501754A (en) * 2008-09-04 2012-01-26 キュラシール インコーポレイテッド Expandable device for multiple intestinal fistula treatment

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