JP4308114B2 - In vivo tissue closure device and in vivo tissue closure device - Google Patents

In vivo tissue closure device and in vivo tissue closure device Download PDF

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JP4308114B2
JP4308114B2 JP2004285184A JP2004285184A JP4308114B2 JP 4308114 B2 JP4308114 B2 JP 4308114B2 JP 2004285184 A JP2004285184 A JP 2004285184A JP 2004285184 A JP2004285184 A JP 2004285184A JP 4308114 B2 JP4308114 B2 JP 4308114B2
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vivo tissue
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tissue closure
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政克 川浦
智司 丸山
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TRUMO KABUSHIKI KAISHA
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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。   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.

カテーテルが挿入される大腿動脈の血管壁の肉厚は、健常な血管の場合で約１ｍｍである。これに対し、心臓等へのカテーテルによる処置および検査を受ける患者においては、心臓以外の箇所においても何らかの血管疾患を患っている可能性があり、カテーテルが挿入される大腿動脈においても血管病変が存在する場合があるので、例えば、血管が肥厚して血管壁の肉厚が２ｍｍ以上あったり、石灰化して血管壁が硬くなっている場合もある。また、複数回カテーテル手技を受けた患者に関しては、血管の穿刺部周辺が繊維化して痕跡となり硬くなってしまう場合もある。また、カテーテルの挿入によって形成される傷の大きさは、血管の弾性、厚み、病変等によって各患者で異なる。このように、カテーテルが留置される患者の血管の状態は、症例によっていろいろである。   The wall thickness of the blood vessel wall of the femoral artery into which the catheter is inserted is about 1 mm in the case of a healthy blood vessel. On the other hand, in patients undergoing treatment and examinations with a catheter to the heart, etc., there may be some vascular disease in locations other than the heart, and vascular lesions also exist in the femoral artery where the catheter is inserted Therefore, for example, the blood vessel may be thickened and the wall thickness of the blood vessel wall may be 2 mm or more, or the blood vessel wall may be hardened due to calcification. In addition, for a patient who has undergone multiple catheterization procedures, the vicinity of the puncture portion of the blood vessel may become fibrotic and become a trace and become hard. In addition, the size of the wound formed by inserting the catheter differs depending on each patient depending on the elasticity, thickness, lesion, etc. of the blood vessel. Thus, the state of the blood vessel of the patient where the catheter is placed varies depending on the case.

近年、前述したような止血作業を容易かつ確実に行うことを目的とした生体内組織閉鎖具が開発されている。その一例として、下記特許文献１には、２つの柔軟な円盤状の部材が中央部で接続されるように一体化された、血管の傷穴を閉鎖する器具が開示されている。しかしながら、このものは、２つの円盤状の部材の位置関係が固定されているため、患者の血管壁の肉厚や血管周辺組織の状態によって、止血効果が左右され、十分な止血効果が得られない場合がある。   In recent years, in-vivo tissue closure devices have been developed for the purpose of easily and reliably performing the hemostasis work described above. As an example, Patent Document 1 listed below discloses an instrument for closing a wound hole in a blood vessel in which two flexible disk-shaped members are integrated so as to be connected at a central portion. However, since the positional relationship between the two disk-shaped members is fixed, the hemostatic effect is influenced by the thickness of the blood vessel wall of the patient and the state of the tissue around the blood vessel, and a sufficient hemostatic effect is obtained. There may not be.

また、下記特許文献２には、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。しかしながら、このものは、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。   Further, in Patent Document 2 below, a closing element to which a thread is attached is disposed in a blood vessel, the ring is slid through the thread, and the ring locks the thread outside the blood vessel, thereby closing the wound of the blood vessel. A device has been proposed. However, this is to fix the ring (locking member) to the thread by any method, but the fixing method is not specifically shown, and the fixing work in the subcutaneous tissue is difficult. Because the outer diameter of the ring needs to be a size that can enter the wound hole, there is a problem that the ring must drop into the blood vessel from the hole formed in the blood vessel, because it must be small. . Moreover, the point which requires the operation | movement which cut | disconnects a thread | yarn in a subcutaneous tissue after a closing operation | work is also complicated.

米国特許第５６９０６７４号明細書US Pat. No. 5,690,674 特許第３１３３０５９号公報Japanese Patent No. 3133059

本発明の目的は、生体内組織膜の肉厚や硬さ等の条件にかかわらず、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。   The object of the present invention is to be able to easily and reliably close the wound formed in the in vivo tissue membrane regardless of conditions such as the thickness and hardness of the in vivo tissue membrane, and to completely stop bleeding. An object of the present invention is to provide an in vivo tissue closing device and an in vivo tissue closing device that are capable of being highly safe.

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、
前記生体内組織膜の一方の面側から前記傷穴および前記傷穴の周辺部を覆うシール部と、
折り畳まれた第１の形態と、前記シール部との間に前記生体内組織膜を挟持可能に拡幅した第２の形態とに変形可能である枠状をなす変形部と、
一端が前記シール部に連結して設けられ、前記変形部を前記第２の形態に保持する固定部とを備え、
前記変形部は、前記固定部が貫通可能な第１の開口部と、前記固定部が貫通可能であるとともに前記第１の開口部よりも前記シール部から遠くにある第２の開口部とを有し、
前記固定部が前記第１の開口部および前記第２の開口部を貫通し、前記第２の開口部が前記固定部と係合して固定されることにより前記変形部が前記第２の形態に保持され、
前記変形部が前記第２の形態になったとき、前記第１の開口部が前記固定部を挿通しつつ前記固定部に対し変位することにより、前記シール部と前記変形部との間に形成される前記生体内組織膜の挟み代の大きさが可変であ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 seal part that covers the wound hole and the peripheral part of the wound hole from one surface side of the in vivo tissue membrane;
A deformed portion having a frame shape that is deformable into a folded first form and a second form widened so as to sandwich the in vivo tissue membrane between the seal portion,
One end is provided connected to the seal part, and includes a fixing part that holds the deformation part in the second form,
The flexible portion includes: the fixing portion is the first opening capable of penetrating, and the second opening fixing portion Ru far near from said first of said sealing portion than the opening as well as a penetrable Have
The fixing portion penetrates the first opening and the second opening, and the second opening engages with the fixing portion and is fixed, whereby the deforming portion is the second form. Held in
When the deforming portion is in the second form, the first opening is formed between the seal portion and the deforming portion by being displaced with respect to the fixing portion while being inserted through the fixing portion. The in vivo tissue closure device is characterized in that the size of the clamping margin of the in vivo tissue membrane is variable.

（２） 前記変形部が前記第１の形態になっているとき、前記固定部は、前記第１の開口部を貫通しているとともに前記第２の開口部を貫通していない上記（１）に記載の生体内組織閉鎖具。   (2) When the deforming portion is in the first form, the fixing portion passes through the first opening and does not pass through the second opening. The in-vivo tissue closure device described in 1.

（３） 前記変形部が前記第１の形態になっているとき、前記固定部は、前記第１の開口部および前記第２の開口部を貫通している上記（１）に記載の生体内組織閉鎖具。   (3) The living body according to (1), wherein when the deforming portion is in the first form, the fixing portion penetrates the first opening and the second opening. Tissue closure.

（４） 前記固定部は、帯状をなし、その厚さ方向の側には容易に倒れて前記シール部に寄り添うように変形可能であり、前記厚さ方向と直交する方向の側には倒れにくいように構成されている上記（１）ないし（３）のいずれかに記載の生体内組織閉鎖具。   (4) The fixing portion has a belt shape, and can be easily deformed so as to easily fall on the side in the thickness direction and snuggle up to the seal portion, and hardly fall on the side in the direction orthogonal to the thickness direction. The in-vivo tissue closure device according to any one of (1) to (3) configured as described above.

（５） 前記固定部の根元付近の部分は、他の部分に対し幅が広くなっている上記（４）に記載の生体内組織閉鎖具。   (5) The in-vivo tissue closure device according to (4), wherein a portion near the base of the fixing portion is wider than other portions.

（６） 前記変形部は、多角形状をなし、その角部のうちの２つに前記第１の開口部および前記第２の開口部がそれぞれ形成されている上記（１）ないし（５）のいずれかに記載の生体内組織閉鎖具。   (6) The deforming portion has a polygonal shape, and the first opening and the second opening are formed in two of the corner portions, respectively, according to (1) to (5) above. The in-vivo tissue closure device according to any one of the above.

（７） 前記変形部は、４つのリンクを一体的に形成してなる四角形をなし、該四角形の対角位置にある２つの角部同士が接近、離間するように変形するものである上記（１）ないし（６）のいずれかに記載の生体内組織閉鎖具。   (7) The deforming portion is a quadrangle formed by integrally forming four links, and is deformed so that two corners at diagonal positions of the quadrangle approach and separate from each other. The in-vivo tissue closure device according to any one of 1) to (6).

（８） 生体吸収性材料で構成されている上記（１）ないし（７）のいずれかに記載の生体内組織閉鎖具。   (8) The in-vivo tissue closure device according to any one of (1) to (7), which is made of a bioabsorbable material.

（９） 上記（１）ないし（８）のいずれかに記載の生体内組織閉鎖具を生体内に配置し、該生体内組織閉鎖具により生体内組織膜を貫通する傷穴を閉じる生体内組織閉鎖装置であって、
上記（１）ないし（８）のいずれかに記載の生体内組織閉鎖具と、
先端部において前記生体内組織閉鎖具を着脱自在に保持する長尺部材とを有することを特徴とする生体内組織閉鎖装置。 (9) An in vivo tissue in which the in vivo tissue closure device according to any one of (1) to (8) is disposed in a living body, and a wound hole penetrating the in vivo tissue membrane is closed by the in vivo tissue closure device A closure device,
The in-vivo tissue closure device according to any one of (1) to (8) above,
An in-vivo tissue closing device comprising: a long member that detachably holds the in-vivo tissue closing tool at a distal end portion.

（１０） 前記生体内組織閉鎖具の変形部を前記第１の形態から前記第２の形態へ変形させる操作を行う操作手段を有する上記（９）に記載の生体内組織閉鎖装置。   (10) The in-vivo tissue closing device according to (9), further including operation means for performing an operation of deforming the deforming portion of the in-vivo tissue closing tool from the first form to the second form.

（１１） 前記操作手段は、前記固定部を基端側へ牽引する牽引手段と、前記変形部を先端側へ押圧する押圧手段とを有する上記（９）または（１０）に記載の生体内組織閉鎖装置。   (11) The in-vivo tissue according to (9) or (10), wherein the operation unit includes a pulling unit that pulls the fixing unit toward a proximal end and a pressing unit that presses the deforming unit toward a distal end. Closure device.

本発明によれば、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。   According to the present invention, the wound formed in the in vivo tissue membrane can be easily and reliably closed, and hemostasis can be completely performed.

特に、シール部と変形部との間に形成される、生体内組織膜の挟み代の大きさが可変になっているので、生体内組織膜が厚い人、薄い人、硬い人、軟らかい人等の種々の症例に応じて挟み代の間隔が適度な大きさに自動的に調整される。よって、生体内組織膜の厚さや硬さ等の条件にかかわらず、傷穴の周辺の生体内組織膜を適度な力で挟持し、迅速かつ確実に止血することができる。また、生体内組織膜にダメージを与えることもない。   In particular, since the size of the pinching margin of the in vivo tissue membrane formed between the seal portion and the deformable portion is variable, people with thick tissue tissue, thin people, hard people, soft people, etc. The interval of the pinch allowance is automatically adjusted to an appropriate size according to various cases. Therefore, regardless of conditions such as the thickness and hardness of the in vivo tissue membrane, the in vivo tissue membrane around the wound can be clamped with an appropriate force, and hemostasis can be performed quickly and reliably. In addition, the tissue tissue in vivo is not damaged.

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な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におけるシール部および固定部を示す斜視図、図２は、本発明の生体内組織閉鎖具における変形部を示す斜視図、図３ないし図５は、それぞれ、本発明の生体内組織閉鎖具を示す斜視図である。   FIG. 1 is a perspective view showing a seal portion and a fixing portion in the in-vivo tissue closure device of the present invention, FIG. 2 is a perspective view showing a deforming portion in the in-vivo tissue closure device of the present invention, and FIGS. It is a perspective view which shows the in-vivo tissue closure tool of this invention, respectively.

本発明の生体内組織閉鎖具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９０（生体内組織膜を貫通する傷穴）を閉じる（閉鎖する）ための器具である。   The in-vivo tissue closure device 1 of the present invention is formed in a in-vivo tissue membrane such as a living body lumen such as a blood vessel, in-vivo internal organ, or in-vivo internal tissue, and percutaneously penetrates a wound 90 (in-vivo tissue). It is a device for closing (closing) a wound hole penetrating the membrane.

この生体内組織閉鎖具１は、図１に示すシール部２および固定部３と、図２に示す変形部４とで構成される。まず、シール部２および固定部３について説明する。   This in-vivo tissue closure tool 1 includes a seal portion 2 and a fixing portion 3 shown in FIG. 1 and a deforming portion 4 shown in FIG. First, the seal part 2 and the fixing part 3 will be described.

図１に示すように、シール部２は、生体内組織膜の一方の面（内面）側から傷穴９０の周辺部（生体内組織膜の傷穴９０を含む部分）に密着して傷穴９０を覆う平面部２１を有する部材であり、板状（平面視で略舟形）をなしている。ここで、生体内組織膜が、血管壁（生体管腔壁）である場合は、前記一方の面は、血管壁（生体管腔壁）の内面であり、前記他方の面は、血管壁（生体管腔壁）の外面である。   As shown in FIG. 1, the seal portion 2 is in close contact with a peripheral portion of the wound hole 90 (a portion including the wound hole 90 in the biological tissue membrane) from one surface (inner surface) side of the biological tissue membrane. 90 is a member having a flat surface portion 21 covering 90, and has a plate shape (substantially boat-shaped in a plan view). Here, when the in-vivo tissue membrane is a blood vessel wall (biological lumen wall), the one surface is an inner surface of the blood vessel wall (biological lumen wall), and the other surface is a blood vessel wall ( It is the outer surface of the biological lumen wall.

固定部３は、後述するように、変形部４を第２の形態に保持する機能を有している。この固定部３は、帯状（長方形の板状）をなしており、その一端は、シール部２の平面部２１の中央に連結されている。   The fixing | fixed part 3 has the function to hold | maintain the deformation | transformation part 4 in a 2nd form so that it may mention later. The fixing portion 3 has a strip shape (rectangular plate shape), and one end thereof is connected to the center of the flat portion 21 of the seal portion 2.

固定部３の頂部付近には、変形部４の第２の開口部４４に係合する係合部３１が設けられている。係合部３１は、固定部３の片面側に、間隔をおいて平行に形成された係合凸部（凸条）３１１、３１３を有しており、両係合凸部３１１、３１３の間に係合溝３１２が形成されている。係合凸部３１１、３１３および係合溝３１２は、固定部３の長手方向と直交する方向に沿って形成されている。   An engaging portion 31 that engages with the second opening 44 of the deformable portion 4 is provided near the top of the fixed portion 3. The engaging portion 31 has engaging convex portions (protrusions) 311 and 313 formed parallel to each other on one side of the fixed portion 3, and between the engaging convex portions 311 and 313. An engagement groove 312 is formed in the upper surface. The engaging convex portions 311 and 313 and the engaging groove 312 are formed along a direction orthogonal to the longitudinal direction of the fixed portion 3.

この固定部３は、その根元が屈曲しやすいため、その厚さ方向の側、すなわちシール部２の長手方向側には容易に倒れてシール部２に寄り添うように変形可能である。これに対し、固定部３は、その面内方向の側、すなわちシール部２の長手方向と直交する方向の側には倒れにくい。これにより、生体内組織閉鎖具１を穿刺部位に留置されたシース６内に挿入する際、この挿入をし易いように、シール部２と固定部３とが平行に近くなる姿勢に容易に変形させることができる。   Since the base of the fixing portion 3 is easily bent, the fixing portion 3 can be deformed so as to easily fall down on the side in the thickness direction, that is, the longitudinal direction side of the seal portion 2 and to approach the seal portion 2. On the other hand, the fixing portion 3 is unlikely to fall on the side in the in-plane direction, that is, the side in the direction orthogonal to the longitudinal direction of the seal portion 2. Thereby, when inserting the in-vivo tissue closure device 1 into the sheath 6 placed at the puncture site, the seal portion 2 and the fixing portion 3 are easily deformed into a posture close to parallel so that the insertion is easy. Can be made.

固定部３の、シール部２に対する根元付近の部分には、他の部分に対し幅が広くなった広幅部３２が形成されている。この広幅部３２の幅は、傷穴９０の幅にほぼ一致した寸法とされているのが好ましい。これにより、生体内組織閉鎖具１を傷穴９０に留置した後、位置ズレを起こすのをより確実に防止することができる。なお、傷穴９０の幅は、イントロデューサーシースの外径と等しいため、広幅部３２の幅は、後述するシース６の外径とほぼ等しい寸法としておけばよい。   A wide portion 32 having a width wider than the other portions is formed in a portion of the fixed portion 3 near the base with respect to the seal portion 2. The width of the wide portion 32 is preferably set to a dimension that substantially matches the width of the flaw hole 90. Thereby, after in-vivo tissue closure tool 1 is detained in wound hole 90, it can prevent more certainly that position shift occurs. In addition, since the width | variety of the wound hole 90 is equal to the outer diameter of an introducer sheath, the width | variety of the wide part 32 should just be a dimension substantially equal to the outer diameter of the sheath 6 mentioned later.

なお、図示の構成と異なり、広幅部３２がなく、固定部３がシール部２との境界部までストレートに形成されていてもよい。   Unlike the illustrated configuration, the wide portion 32 may not be provided, and the fixed portion 3 may be formed straight up to the boundary with the seal portion 2.

固定部３の頂部付近には、後述する牽引手段としての糸８が挿通する糸挿通孔３３が形成されている。   A thread insertion hole 33 is formed in the vicinity of the top of the fixed portion 3 to allow a thread 8 as a pulling means to be described later to pass therethrough.

また、固定部３の、係合部３１と広幅部３２との間の中間部３４は、凹凸のない部分とされている。   Moreover, the intermediate part 34 between the engaging part 31 and the wide part 32 of the fixed part 3 is a part without unevenness.

シール部２および固定部３は、同一の材料で一体的に形成されているのが好ましいが、複数部品を組み合わせて構成されていてもよい。   The seal portion 2 and the fixing portion 3 are preferably formed integrally with the same material, but may be configured by combining a plurality of parts.

図２に示す変形部４は、折り畳まれた第１の形態と、シール部２の平面部２１との間に生体内組織膜を挟持可能に拡幅した第２の形態とに変形可能な枠状の部材であり、シール部２および固定部３とは別部材として構成されている。   The deformable portion 4 shown in FIG. 2 has a frame shape that can be deformed into a folded first form and a second form in which the in vivo tissue membrane is widened so as to be sandwiched between the flat portion 21 of the seal portion 2. The seal portion 2 and the fixing portion 3 are configured as separate members.

ここで、本実施形態では、変形部４は、４つのリンクを一体的に形成してなり、ヒンジ状に屈曲可能な４つの角部を有する四角形（四角形の枠状）をなしている。この変形部４は、図２中上下方向の対角位置にある２つの角部４１と角部４２とが互いに接近、離間することにより、図３に示す第１の形態と、図５に示す第２の形態とに変形する。   Here, in this embodiment, the deformation | transformation part 4 has formed the four links integrally, and has comprised the square (quadrangle frame shape) which has four corner | angular parts which can be bent like a hinge. This deformable portion 4 has the first form shown in FIG. 3 and the one shown in FIG. 5 when the two corner portions 41 and the corner portions 42 at diagonal positions in the vertical direction in FIG. 2 approach and separate from each other. It changes to the 2nd form.

角部４１、４２のうちの図２中下側の角部４１には、固定部３が貫通（挿通）可能な第１の開口部４３が形成されており、図２中上側の角部４２には、固定部３が貫通（挿通）可能な第２の開口部４４が形成されている。第１の開口部４３、第２の開口部４４は、それぞれ、略Ｈ字状の孔で構成されている。   The lower corner 41 in FIG. 2 of the corners 41 and 42 is formed with a first opening 43 through which the fixing portion 3 can pass (inserted), and the upper corner 42 in FIG. 2. Is formed with a second opening 44 through which the fixing portion 3 can penetrate (insert). The first opening 43 and the second opening 44 are each configured by a substantially H-shaped hole.

変形部４の４つのリンクのうち、角部４１を挟む２つのリンク４５、４５の長さは、角部４２を挟む２つのリンク４６、４６の長さよりも短くされている。   Of the four links of the deformable portion 4, the lengths of the two links 45, 45 sandwiching the corner portion 41 are shorter than the lengths of the two links 46, 46 sandwiching the corner portion 42.

図３に示すように、本実施形態の生体内組織閉鎖具１では、変形部４が第１の形態になっているとき、固定部３は、第１の開口部４３を貫通しており、かつ第２の開口部４４を貫通していない状態とされる。この状態では、係合部３１は、第１の開口部４３を通過して、変形部４の枠の内側に入っている。すなわち、第１の開口部４３は、中間部３４を挿通している。第１の開口部４３は、中間部３４に沿って固定部３の長手方向に変位（スライド移動）可能になっている。   As shown in FIG. 3, in the in-vivo tissue closure device 1 of the present embodiment, when the deforming portion 4 is in the first form, the fixing portion 3 passes through the first opening 43, In addition, the second opening 44 is not penetrated. In this state, the engaging portion 31 passes through the first opening 43 and is inside the frame of the deformable portion 4. In other words, the first opening 43 passes through the intermediate portion 34. The first opening 43 can be displaced (slidably moved) in the longitudinal direction of the fixed portion 3 along the intermediate portion 34.

また、図３に示す状態では、糸８は、同図中上側から第２の開口部４４を挿通し、固定部３の糸挿通孔３３を挿通して、さらに同図中下側から第２の開口部４４を挿通するように配設されている。   In the state shown in FIG. 3, the yarn 8 is inserted through the second opening 44 from the upper side in the drawing, through the yarn insertion hole 33 of the fixing portion 3, and further from the lower side in the drawing. It arrange | positions so that the opening part 44 of this may be penetrated.

変形部４は、以下に説明するような操作により、図３に示す第１の形態から、図５に示す第２の形態へと変形させられる。   The deformation unit 4 is deformed from the first form shown in FIG. 3 to the second form shown in FIG. 5 by an operation as described below.

図３に示す状態から、糸８を基端方向に引いて張力をかけながら、後述するプッシャー７を先端方向に押すと、糸８が固定部３を基端方向に牽引しつつプッシャー７が変形部４の角部４２を先端方向に押圧することにより、第１の開口部４３（角部４１）が固定部３の根元側へ移動し、広幅部３２に当接し、さらに、角部４２が角部４１へ接近して、変形部４が拡幅していく（図４参照）。   From the state shown in FIG. 3, when the pusher 7 described later is pushed in the distal direction while pulling the yarn 8 in the proximal direction and applying tension, the pusher 7 is deformed while the yarn 8 pulls the fixing portion 3 in the proximal direction. By pressing the corner portion 42 of the portion 4 in the distal direction, the first opening 43 (corner portion 41) moves to the base side of the fixed portion 3, contacts the wide portion 32, and the corner portion 42 Approaching the corner portion 41, the deformable portion 4 widens (see FIG. 4).

図４に示す状態から、さらに糸８に張力をかけつつ、プッシャー７を先端方向に押すと、固定部３の頂部が第２の開口部４４を貫通する。固定部３を挿通した第２の開口部４４は、その縁部が係合部３１の係合溝３１２に挿入して係合することにより、固定部３に固定される。これにより、図５に示すように、角部４２が角部４１から離間しないように保持されて、変形部４が第２の形態に維持される状態となる。   From the state shown in FIG. 4, when the pusher 7 is pushed in the distal direction while further applying tension to the yarn 8, the top of the fixing portion 3 penetrates the second opening 44. The second opening 44 inserted through the fixing portion 3 is fixed to the fixing portion 3 by inserting and engaging the edge of the second opening 44 in the engaging groove 312 of the engaging portion 31. Thereby, as shown in FIG. 5, the corner portion 42 is held so as not to be separated from the corner portion 41, and the deformable portion 4 is maintained in the second form.

図５に示す状態では、角部４１を挟む２つのリンク４５、４５が開いて、これらリンク４５、４５の外面が、シール部２の平面部２１に対向するように位置する。これにより、リンク４５、４５の外面と、平面部２１との間に、傷穴９０の周辺の生体内組織膜を挟持することができる。   In the state shown in FIG. 5, the two links 45, 45 sandwiching the corner portion 41 are opened, and the outer surfaces of these links 45, 45 are positioned so as to face the flat portion 21 of the seal portion 2. Thereby, the in-vivo tissue film | membrane of the periphery of the wound 90 can be pinched | interposed between the outer surface of the links 45 and 45, and the plane part 21. FIG.

また、本発明の生体内組織閉鎖具では、図５に示す状態で第１の開口部４３が中間部３４に沿って固定部３の長手方向に変位（移動）可能になっており、これにより、リンク４５、４５の外面と平面部２１との間に形成される、生体内組織膜の挟み代（隙間）１０の大きさが可変になっている。よって、生体内組織膜が厚い人、薄い人、硬い人、軟らかい人等の種々の症例に応じて挟み代１０の間隔が適度な大きさに自動的に調整されるので、生体内組織膜の厚さや硬さ等の条件にかかわらず、傷穴９０の周辺の生体内組織膜を適度な力で挟持し、迅速かつ確実に止血することができるとともに、生体内組織膜にダメージを与えることもない。   In the in-vivo tissue closure device of the present invention, the first opening 43 can be displaced (moved) in the longitudinal direction of the fixed portion 3 along the intermediate portion 34 in the state shown in FIG. The size of the clamping margin (gap) 10 of the tissue tissue in the living body formed between the outer surface of the links 45 and 45 and the flat surface portion 21 is variable. Therefore, the interval of the pinching allowance 10 is automatically adjusted to an appropriate size according to various cases such as a thick person, a thin person, a hard person, a soft person, etc. Regardless of conditions such as thickness and hardness, the in vivo tissue membrane around the wound hole 90 can be clamped with an appropriate force to stop hemostasis quickly and reliably, and damage the in vivo tissue membrane. Absent.

なお、図５に示す状態では、変形部４の弾性により、挟み代１０が小さくなる方向に付勢されている。これにより、挟み代１０の大きさは、挟持された生体内組織膜に適合した大きさに自動的に変化する。   In the state shown in FIG. 5, the pinching allowance 10 is urged in a direction of decreasing by the elasticity of the deformable portion 4. Thereby, the size of the pinching allowance 10 automatically changes to a size suitable for the pinched in-vivo tissue membrane.

また、図示の構成では、広幅部３２の幅は、変形部４の第１の開口部４３の幅より大きくなっており、これにより、広幅部３２は、第１の開口部４３に挿入できない。よって、広幅部３２の高さは、挟み代１０の最小寸法を規定する機能を有する。この観点から、広幅部３２の高さは、生体内組織膜（血管壁）の厚み以下であるのが好ましく、具体的には、最も薄いと考えられる正常血管の厚み（約１ｍｍ）より小さいことが好ましい。   Further, in the illustrated configuration, the width of the wide portion 32 is larger than the width of the first opening 43 of the deformable portion 4, whereby the wide portion 32 cannot be inserted into the first opening 43. Therefore, the height of the wide portion 32 has a function of defining the minimum dimension of the pinching allowance 10. From this point of view, the width of the wide portion 32 is preferably equal to or less than the thickness of the in-vivo tissue membrane (blood vessel wall), and specifically, smaller than the thickness of the normal blood vessel considered to be the thinnest (about 1 mm). Is preferred.

生体内組織閉鎖具１は、生体吸収性材料で構成されているのが好ましい。これにより、生体内組織閉鎖具１の主要部分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。   The in-vivo tissue closure device 1 is preferably made of a bioabsorbable material. Thereby, since the main part of the in-vivo tissue closure tool 1 is absorbed by the living body after a predetermined period and does not finally 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.

なお、生体内組織閉鎖具１の構成材料としては、生体吸収性材料に限らず、例えば、樹脂や金属等の生体適合性材料を用いることができる。   In addition, as a constituent material of the in-vivo tissue closure tool 1, not only a bioabsorbable material but biocompatible materials, such as resin and a metal, can be used, for example.

また、変形部４の変形機能に求められる材料物性としては、ヒンジ特性に優れたものであることが望ましい。具体的には、引張り強さ２５０〜５００（ｋｇ／ｃｍ２）、伸び１５０〜８００％、引張弾性率８〜２０（×１０３ｋｇ／ｃｍ２）、曲げ強さ３００〜７００（ｋｇ／ｃｍ２）のものが好ましい。これらの物性値を満たすことによって、変形部４は、ヒンジ特性に優れ、変形部４が所望の変形能を有することができる。 Moreover, as a material physical property calculated | required by the deformation | transformation function of the deformation | transformation part 4, it is desirable that it is excellent in the hinge characteristic. Specifically, the tensile strength is 250 to 500 (kg / cm 2 ), the elongation is 150 to 800%, the tensile modulus is 8 to 20 (× 103 kg / cm 2 ), and the bending strength is 300 to 700 (kg / cm 2 ). Are preferred. By satisfying these physical property values, the deformable portion 4 is excellent in hinge characteristics, and the deformable portion 4 can have a desired deformability.

図７ないし図１０は、それぞれ、図３ないし図５に示す生体内組織閉鎖具を備えた本発明の生体内組織閉鎖装置の作用（動作）および構成を説明するための断面側面図である。   FIGS. 7 to 10 are cross-sectional side views for explaining the operation (operation) and configuration of the in-vivo tissue closing device of the present invention provided with the in-vivo tissue closing tool shown in FIGS. 3 to 5, respectively.

なお、説明の都合上、図７〜図１０において、図中の左下側を「先端」、右上側（手元側）を「基端」として説明する。   For convenience of explanation, in FIGS. 7 to 10, the lower left side in the figure is referred to as “tip” and the upper right side (hand side) is referred to as “base end”.

これらの図に示す生体内組織閉鎖装置５は、前述した生体内組織閉鎖具１を備え、この生体内組織閉鎖具１を生体内に挿入して傷穴９０に配置するための装置である。   The in-vivo tissue closing device 5 shown in these drawings includes the in-vivo tissue closing device 1 described above, and is a device for inserting the in-vivo tissue closing device 1 into the living body and placing it in the wound 90.

図７に示すように、生体内組織閉鎖装置５は、シース６と、シース６内に挿入可能であり、その先端部において生体内組織閉鎖具１を着脱自在に保持する細長いプッシャー（長尺部材）７と、糸８と、糸留めキャップ（糸保持部材）９とを有している。   As shown in FIG. 7, the in-vivo tissue closing device 5 includes a sheath 6 and an elongate pusher (elongate member) that can be inserted into the sheath 6 and detachably holds the in-vivo tissue closing device 1 at its distal end. ) 7, a thread 8, and a thread retaining cap (thread retaining member) 9.

シース６は、可撓性を有する円筒状のシース本体６１と、シース本体６１の基端部に設置されたハブ６２とを有している。このシース６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５専用のものであってもよい。すなわち、生体内組織閉鎖装置５の構成要素には、シース６が含まれていてもよく、また、含まれていなくてもよい。   The sheath 6 has a flexible cylindrical sheath body 61 and a hub 62 installed at the proximal end of the sheath body 61. As the sheath 6, for example, a sheath (introducer sheath) placed after treatment using a catheter (PCI) or diagnosis (CAG) may be used. It may be. That is, the sheath 6 may or may not be included in the components of the in vivo tissue closing device 5.

プッシャー７は、細長いプッシャー本体７１と、プッシャー本体７１の基端部に設けられ、シース６のハブ６２の外側に嵌合可能なハブ７２とで構成されている。   The pusher 7 includes an elongated pusher main body 71 and a hub 72 that is provided at the proximal end of the pusher main body 71 and can be fitted to the outside of the hub 62 of the sheath 6.

プッシャー本体７１の先端部には、中空部７３が形成されている。生体内組織閉鎖具１は、この中空部７３内に変形部４の一部が挿入された状態で、プッシャー本体７１の先端部に保持されている。   A hollow portion 73 is formed at the tip of the pusher body 71. The in-vivo tissue closure tool 1 is held at the distal end portion of the pusher main body 71 with a part of the deformable portion 4 being inserted into the hollow portion 73.

プッシャー７の中心部には、その全長に渡り糸挿通孔７４が形成されている。生体内組織閉鎖具１の固定部３の糸挿通孔３３に通された糸８は、この糸挿通孔７４に通されており、糸８の両端側は、糸挿通孔７４の基端開口から外部へ露出している。   A thread insertion hole 74 is formed at the center of the pusher 7 over the entire length thereof. The thread 8 passed through the thread insertion hole 33 of the fixing part 3 of the in-vivo tissue closure device 1 is passed through the thread insertion hole 74, and both ends of the thread 8 are connected to the base end opening of the thread insertion hole 74. It is exposed to the outside.

このようなプッシャー７と、糸８とにより、生体内組織閉鎖具１の変形部４を第１の形態から第２の形態へ変形させる操作を行う操作手段が構成される。そして、プッシャー７は、変形部４を先端側へ押圧する押圧手段として機能する。   The pusher 7 and the thread 8 constitute an operation means for performing an operation of deforming the deformable portion 4 of the in-vivo tissue closure device 1 from the first form to the second form. The pusher 7 functions as a pressing unit that presses the deformable portion 4 toward the distal end side.

糸挿通孔７４の基端開口には、糸留めキャップ９が嵌入されており、糸８は、この糸留めキャップ９と糸挿通孔７４の基端開口内周面との間に挟まれて、固定されている。   A thread fixing cap 9 is fitted into the proximal end opening of the thread insertion hole 74, and the thread 8 is sandwiched between the thread retaining cap 9 and the inner peripheral surface of the proximal end opening of the thread insertion hole 74. It is fixed.

このような構成により、糸留めキャップ９が装着されている状態では、糸８の張力により、生体内組織閉鎖具１がプッシャー本体７１の先端部に保持される。   With such a configuration, the in-vivo tissue closure device 1 is held at the distal end portion of the pusher body 71 by the tension of the thread 8 in a state where the thread cap 9 is attached.

次に、生体内組織閉鎖装置５を用いて行なう止血作業の手順について、図６ないし図１１を参照しつつ、順を追って説明する。   Next, the procedure of hemostasis work performed using the in-vivo tissue closing apparatus 5 will be described step by step with reference to FIGS.

図６に示すように、経皮的にカテーテルを挿入して治療（ＰＣＩ）や診断（ＣＡＧ）等の処置がなされた後には、シース６が穿刺部位に留置されており、このシース６の先端部は、血管壁に形成された傷穴９０を通ってこの血管内に挿入されている。   As shown in FIG. 6, after the catheter is inserted percutaneously and treatment (PCI), diagnosis (CAG), or the like is performed, the sheath 6 is indwelled at the puncture site. The part is inserted into this blood vessel through a wound hole 90 formed in the blood vessel wall.

図７に示すように、先端部に生体内組織閉鎖具１を保持したプッシャー７を、シース６の基端開口からシース６内に挿入してゆく。そして、図８に示すように、シース６のハブ６２にプッシャー７のハブ７２とを嵌合させると、シース６の先端開口からプッシャー本体７１の先端部が突出して、生体内組織閉鎖具１が血管内に挿入される。   As shown in FIG. 7, the pusher 7 holding the in-vivo tissue closure 1 at the distal end is inserted into the sheath 6 from the proximal end opening of the sheath 6. As shown in FIG. 8, when the hub 72 of the pusher 7 is fitted to the hub 62 of the sheath 6, the distal end portion of the pusher body 71 protrudes from the distal end opening of the sheath 6, and the in-vivo tissue closure device 1 is Inserted into blood vessels.

次に、図９に示すように、合体したシース６およびプッシャー７をゆっくり穿刺部位から引き抜く方向に移動させると、シール部２が血管壁の内面に当接し、傷穴９０および傷穴９０の周辺部がシール部２に覆われる。これにより、変形部４および固定部３は、それぞれ、血管の外側に移動する。   Next, as shown in FIG. 9, when the united sheath 6 and pusher 7 are slowly moved in the direction of pulling out from the puncture site, the seal portion 2 comes into contact with the inner surface of the blood vessel wall, and the wound hole 90 and the periphery of the wound hole 90 The part is covered with the seal part 2. Thereby, the deformation | transformation part 4 and the fixing | fixed part 3 each move outside the blood vessel.

なお、術者は、前記シール部２で傷穴９０および傷穴９０の周辺部を覆う際の作業（操作）においては、シース６およびプッシャー７を傷穴９０から引き抜く方向に移動させた際、シール部２が傷穴９０およびその周辺組織に当接したときの抵抗（面当て抵抗）を感知すると、シール部２が傷穴９０およびその周辺組織に当接し（面当てされ）、シール部２の位置決めが完了したものと判断する。   In the operation (operation) when the surgeon covers the wound hole 90 and the peripheral part of the wound hole 90 with the seal portion 2, the surgeon moves the sheath 6 and the pusher 7 in the direction of pulling out from the wound hole 90. When the resistance (surface contact resistance) is detected when the seal portion 2 comes into contact with the wound hole 90 and the surrounding tissue, the seal portion 2 makes contact (face contact) with the wound hole 90 and the surrounding tissue. Is determined to have been completed.

次に、図１０に示すように、糸留めキャップ９をプッシャー７のハブ７２から取り外す。そして、糸８を少し引いてテンションを加えつつ、プッシャー７を先端方向に押すと、、図１１（ａ）に示すように、プッシャー本体７１の先端部（中空部７３付近の部位）が変形部４を押圧することにより、変形部４が第２の形態に変形する。このとき、同図に示すように、プッシャー本体７１の中空部７３付近の部位は、弾性的に変形して拡径するので、変形部４が拡幅するのを妨げることはない。   Next, as shown in FIG. 10, the thread cap 9 is removed from the hub 72 of the pusher 7. When the pusher 7 is pushed in the distal direction while pulling the thread 8 slightly and applying tension, as shown in FIG. 11 (a), the distal end portion of the pusher body 71 (the portion near the hollow portion 73) is deformed. By pressing 4, the deforming portion 4 is deformed into the second form. At this time, as shown in the figure, the portion near the hollow portion 73 of the pusher main body 71 is elastically deformed and diameter-expanded, so that the deformation portion 4 is not prevented from widening.

変形部４が第２の形態に変形すると、リンク４５、４５の外面が血管壁の外側から傷穴９０および傷穴９０の周辺部を覆い、シール部２の平面部２１が血管壁の内側から傷穴９０および傷穴９０の周辺部を覆うことにより、両者の間に血管壁が挟み込まれ、傷穴９０が閉じる。そして、固定部３の係合部３１が変形部４の第２の開口部４４に係合して、変形部４が第２の形態に保持される。   When the deforming portion 4 is deformed to the second form, the outer surfaces of the links 45, 45 cover the wound hole 90 and the peripheral portion of the wound hole 90 from the outside of the blood vessel wall, and the flat portion 21 of the seal portion 2 from the inside of the blood vessel wall. By covering the wound hole 90 and the periphery of the wound hole 90, the blood vessel wall is sandwiched between the two and the wound hole 90 is closed. And the engaging part 31 of the fixing | fixed part 3 engages with the 2nd opening part 44 of the deformation | transformation part 4, and the deformation | transformation part 4 is hold | maintained at a 2nd form.

次に、図１１（ｂ）に示すように、シース６およびプッシャー７を穿刺部位から抜去し、さらに、図１１（ｃ）に示すように、糸８を抜去することにより、止血作業が完了する。   Next, as shown in FIG. 11 (b), the sheath 6 and the pusher 7 are removed from the puncture site, and further, as shown in FIG. 11 (c), the thread 8 is removed to complete the hemostasis operation. .

図１１（ｃ）に示す状態では、前述したように、血管壁の挟み代１０の大きさが可変になっているので、血管壁が厚い人、薄い人、硬い人、軟らかい人等の種々の症例に応じて挟み代１０の間隔が適度な大きさに自動的に調整され、血管壁の厚さや硬さ等の条件にかかわらず、傷穴９０の周辺の血管壁を適度な力で挟持し、迅速かつ確実に止血することができる。また、血管壁にダメージを与えることもない。   In the state shown in FIG. 11 (c), as described above, the size of the pinch allowance 10 of the blood vessel wall is variable, so that various kinds of people such as a person with a thick blood vessel, a thin person, a hard person, a soft person, etc. The interval of the pinch allowance 10 is automatically adjusted to an appropriate size according to the case, and the blood vessel wall around the wound hole 90 is pinched with an appropriate force regardless of conditions such as the thickness and hardness of the blood vessel wall. Can stop bleeding quickly and reliably. In addition, the blood vessel wall is not damaged.

図１２は、本発明の生体内組織閉鎖具の他の構成例を示す斜視図であり、変形部４が第１の形態のときを示す図である。以下、同図を参照して、本発明の生体内組織閉鎖具の他の構成例について説明するが、前述した実施形態との相違点を中心に説明し、同様の事項については、その説明を省略する。   FIG. 12 is a perspective view showing another configuration example of the in-vivo tissue closure device of the present invention, and is a view showing when the deforming portion 4 is in the first form. Hereinafter, other configuration examples of the in-vivo tissue closure device of the present invention will be described with reference to the same drawing, but the description will focus on differences from the above-described embodiment, and the same matters will be described. Omitted.

図１２に示す生体内組織閉鎖具１’は、前述した生体内組織閉鎖具１と比べ、固定部３が係合部３１より上側へ延長して形成されており、変形部４が第１の形態のときに、既に固定部３が第２の開口部４４を貫通した状態とされている。これにより、変形部４を第２の形態に変形させるとき、第２の開口部４４が固定部３の延長部分（ガイド部）３５を通って係合部３１へ案内されるので、変形部４のブレが防止され、変形部４をより円滑かつ確実に第２の形態に変形させることができる。   The in-vivo tissue closure device 1 ′ shown in FIG. 12 is formed by extending the fixing portion 3 to the upper side from the engagement portion 31 as compared with the in-vivo tissue closure device 1 described above, and the deformation portion 4 is the first. In the form, the fixing portion 3 has already passed through the second opening 44. Thus, when the deforming portion 4 is deformed to the second form, the second opening 44 is guided to the engaging portion 31 through the extension portion (guide portion) 35 of the fixing portion 3. Is prevented, and the deformable portion 4 can be more smoothly and reliably deformed into the second form.

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 closure tool and in-vivo tissue closure 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. It can be replaced with one having any structure. In addition, any other component may be added to the present invention.

本発明の生体内組織閉鎖具におけるシール部および固定部を示す斜視図である。It is a perspective view which shows the seal | sticker part and fixing | fixed part in the in-vivo tissue closure tool of this invention. 本発明の生体内組織閉鎖具における変形部を示す斜視図である。It is a perspective view which shows the deformation | transformation part in the in-vivo tissue closure tool of this invention. 本発明の生体内組織閉鎖具を示す斜視図である。It is a perspective view which shows the in-vivo tissue closure tool of this invention. 本発明の生体内組織閉鎖具を示す斜視図である。It is a perspective view which shows the in-vivo tissue closure tool of this invention. 本発明の生体内組織閉鎖具を示す斜視図である。It is a perspective view which shows the in-vivo tissue closure tool of this invention. 生体の穿刺部位に留置されたシースを示す断面側面図である。It is a cross-sectional side view which shows the sheath detained in the puncture site | part of the biological body. 図３ないし図５に示す生体内組織閉鎖具を備えた本発明の生体内組織閉鎖装置の作用（動作）および構成を説明するための断面側面図である。FIG. 6 is a cross-sectional side view for explaining the operation (operation) and configuration of the in-vivo tissue closing device of the present invention provided with the in-vivo tissue closing tool shown in FIGS. 3 to 5. 図３ないし図５に示す生体内組織閉鎖具を備えた本発明の生体内組織閉鎖装置の作用（動作）および構成を説明するための断面側面図である。FIG. 6 is a cross-sectional side view for explaining the operation (operation) and configuration of the in-vivo tissue closing device of the present invention provided with the in-vivo tissue closing tool shown in FIGS. 3 to 5. 図３ないし図５に示す生体内組織閉鎖具を備えた本発明の生体内組織閉鎖装置の作用（動作）および構成を説明するための断面側面図である。FIG. 6 is a cross-sectional side view for explaining the operation (operation) and configuration of the in-vivo tissue closing device of the present invention provided with the in-vivo tissue closing tool shown in FIGS. 3 to 5. 図３ないし図５に示す生体内組織閉鎖具を備えた本発明の生体内組織閉鎖装置の作用（動作）および構成を説明するための断面側面図である。FIG. 6 is a cross-sectional side view for explaining the operation (operation) and configuration of the in-vivo tissue closing device of the present invention provided with the in-vivo tissue closing tool shown in FIGS. 3 to 5. 図３ないし図５に示す生体内組織閉鎖具の作用を説明するための断面側面図である。FIG. 6 is a cross-sectional side view for explaining the operation of the in-vivo tissue closure device shown in FIGS. 3 to 5. 本発明の生体内組織閉鎖具の他の構成例を示す斜視図である。It is a perspective view which shows the other structural example of the in-vivo tissue closure tool of this invention.

符号の説明Explanation of symbols

１、１’ 生体内組織閉鎖具
１０ 挟み代
２ シール部
２１ 平面部
３ 固定部
３１ 係合部
３１１、３１３ 係合凸部
３１２ 係合溝
３２ 広幅部
３３ 糸挿通孔
３４ 中間部
３５ 延長部分
４ 変形部
４１、４２ 角部
４３ 第１の開口部
４４ 第２の開口部
４５、４６ リンク
５ 生体内組織閉鎖装置
６ シース
６１ シース本体
６２ ハブ
７ プッシャー
７１ プッシャー本体
７２ ハブ
７３ 中空部
７４ 糸挿通孔
８ 糸
９ 糸留めキャップ
９０ 傷穴 DESCRIPTION OF SYMBOLS 1, 1 'In-vivo tissue closure device 10 Clamping margin 2 Seal part 21 Plane part 3 Fixing part 31 Engagement part 311, 313 Engagement convex part 312 Engagement groove 32 Wide part 33 Thread insertion hole 34 Intermediate part 35 Extension part 4 Deformation part 41, 42 Corner part 43 1st opening part 44 2nd opening part 45, 46 Link 5 In-vivo tissue closing device 6 Sheath 61 Sheath body 62 Hub 7 Pusher 71 Pusher body 72 Hub 73 Hollow part 74 Thread insertion hole 8 Thread 9 Thread cap 90 Scratch

Claims (11)

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、
前記生体内組織膜の一方の面側から前記傷穴および前記傷穴の周辺部を覆うシール部と、
折り畳まれた第１の形態と、前記シール部との間に前記生体内組織膜を挟持可能に拡幅した第２の形態とに変形可能である枠状をなす変形部と、
一端が前記シール部に連結して設けられ、前記変形部を前記第２の形態に保持する固定部とを備え、
前記変形部は、前記固定部が貫通可能な第１の開口部と、前記固定部が貫通可能であるとともに前記第１の開口部よりも前記シール部から遠くにある第２の開口部とを有し、
前記固定部が前記第１の開口部および前記第２の開口部を貫通し、前記第２の開口部が前記固定部と係合して固定されることにより前記変形部が前記第２の形態に保持され、
前記変形部が前記第２の形態になったとき、前記第１の開口部が前記固定部を挿通しつつ前記固定部に対し変位することにより、前記シール部と前記変形部との間に形成される前記生体内組織膜の挟み代の大きさが可変であ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 seal part that covers the wound hole and the peripheral part of the wound hole from one surface side of the in vivo tissue membrane;
A deformed portion having a frame shape that is deformable into a folded first form and a second form widened so as to sandwich the in vivo tissue membrane between the seal portion,
One end is provided connected to the seal part, and includes a fixing part that holds the deformation part in the second form,
The flexible portion includes: the fixing portion is the first opening capable of penetrating, and the second opening fixing portion Ru far near from said first of said sealing portion than the opening as well as a penetrable Have
The fixing portion penetrates the first opening and the second opening, and the second opening engages with the fixing portion and is fixed, whereby the deforming portion is the second form. Held in
When the deforming portion is in the second form, the first opening is formed between the seal portion and the deforming portion by being displaced with respect to the fixing portion while being inserted through the fixing portion. The in vivo tissue closure device is characterized in that the size of the clamping margin of the in vivo tissue membrane is variable. 前記変形部が前記第１の形態になっているとき、前記固定部は、前記第１の開口部を貫通しているとともに前記第２の開口部を貫通していない請求項１に記載の生体内組織閉鎖具。   2. The raw material according to claim 1, wherein when the deforming portion is in the first form, the fixing portion passes through the first opening and does not pass through the second opening. Body tissue closure. 前記変形部が前記第１の形態になっているとき、前記固定部は、前記第１の開口部および前記第２の開口部を貫通している請求項１に記載の生体内組織閉鎖具。   The in-vivo tissue closure device according to claim 1, wherein when the deforming portion is in the first form, the fixing portion penetrates the first opening and the second opening. 前記固定部は、帯状をなし、その厚さ方向の側には容易に倒れて前記シール部に寄り添うように変形可能であり、前記厚さ方向と直交する方向の側には倒れにくいように構成されている請求項１ないし３のいずれかに記載の生体内組織閉鎖具。   The fixing portion has a belt shape and can be easily deformed so as to easily fall down on the side in the thickness direction and snuggle up to the seal portion, and is not easily tilted on the side in the direction perpendicular to the thickness direction. The in-vivo tissue closure device according to any one of claims 1 to 3. 前記固定部の根元付近の部分は、他の部分に対し幅が広くなっている請求項４に記載の生体内組織閉鎖具。   The in-vivo tissue closure tool according to claim 4, wherein the portion near the base of the fixing portion is wider than other portions. 前記変形部は、多角形状をなし、その角部のうちの２つに前記第１の開口部および前記第２の開口部がそれぞれ形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。   6. The raw material according to claim 1, wherein the deformable portion has a polygonal shape, and the first opening and the second opening are formed in two of the corner portions. Body tissue closure. 前記変形部は、４つのリンクを一体的に形成してなる四角形をなし、該四角形の対角位置にある２つの角部同士が接近、離間するように変形するものである請求項１ないし６のいずれかに記載の生体内組織閉鎖具。   7. The deformable portion is formed into a quadrangle formed by integrally forming four links, and is deformed so that two corners at diagonal positions of the quadrangle approach and separate from each other. An in vivo tissue closure device according to any one of the above. 生体吸収性材料で構成されている請求項１ないし７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 7, which is made of a bioabsorbable material. 請求項１ないし８のいずれかに記載の生体内組織閉鎖具を生体内に配置し、該生体内組織閉鎖具により生体内組織膜を貫通する傷穴を閉じる生体内組織閉鎖装置であって、
請求項１ないし８のいずれかに記載の生体内組織閉鎖具と、
先端部において前記生体内組織閉鎖具を着脱自在に保持する長尺部材とを有することを特徴とする生体内組織閉鎖装置。 An in-vivo tissue closure device, wherein the in-vivo tissue closure device according to any one of claims 1 to 8 is disposed in a living body, and a wound hole penetrating through the in-vivo tissue membrane is closed by the in-vivo tissue closure device,
An in vivo tissue closure device according to any one of claims 1 to 8,
An in-vivo tissue closing device comprising: a long member that detachably holds the in-vivo tissue closing tool at a distal end portion. 前記生体内組織閉鎖具の変形部を前記第１の形態から前記第２の形態へ変形させる操作を行う操作手段を有する請求項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 operation means for performing an operation of deforming the deforming portion of the in-vivo tissue closure tool from the first form to the second form. 前記操作手段は、前記固定部を基端側へ牽引する牽引手段と、前記変形部を先端側へ押圧する押圧手段とを有する請求項９または１０に記載の生体内組織閉鎖装置。   The in-vivo tissue closing device according to claim 9 or 10, wherein the operation means includes pulling means for pulling the fixing portion toward a proximal end, and pressing means for pressing the deformable portion toward a distal end side.
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