JP2025122310A - Biological suturing device - Google Patents
Biological suturing deviceInfo
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Abstract
【課題】縫合糸のリリースを容易にすること。【解決手段】縫合糸50を体内に送り込むための縫合糸挿入用穿刺針1及び縫合糸を体内から引き出すための縫合糸挿入用穿刺針2を並列に配置し、長尺線状の先端がループ状に形成されたスネアループ10を体内に挿脱するための操作ロッド20を含む操作部40とを備え、スネアループ10が鉛直下方向に対して略垂直な方向にループ形状に延び、該ループ形状の先端を交差部分が接触しないように捩った円環状の縫合糸係合部14を有し、スネアループ10の剛性に比べて高剛性な縫合糸50が、縫合糸係合部14に挿入された状態であって操作ロッド20から押し出されることによって、交差部分に押し込まれてスネアループ10の縫合糸係合部14から外れるように構成した生体用縫合装置。【選択図】図8[Problem] To facilitate the release of sutures. [Solution] A biological suturing device comprising a suture insertion puncture needle 1 for feeding a suture 50 into the body and a suture insertion puncture needle 2 for withdrawing the suture from the body, arranged in parallel, and an operating section 40 including an operating rod 20 for inserting and removing a long, linear snare loop 10 formed at its looped tip into and from the body, wherein the snare loop 10 extends in a loop shape in a direction approximately perpendicular to the downward vertical direction and has an annular suture engagement section 14 twisted at the loop tip so that the intersecting portions do not come into contact, and wherein a suture 50 having higher rigidity than the snare loop 10 is inserted into the suture engagement section 14 and pushed out of the operating rod 20, whereby the suture 50 is pushed into the intersecting portion and released from the suture engagement section 14 of the snare loop 10. [Selected Figure] Figure 8
Description
本発明は、例えば患者の胃壁を腹壁に一時的に固定するために胃壁と腹壁とを縫合するため等に用いられる生体用縫合装置に係り、特に体内に縫合糸引出用穿刺針によって送り込んでスネアループに保持した縫合糸をスネアループから容易に取り外すことができる生体用縫合装置に関する。 The present invention relates to a biological suturing device used, for example, to suture the stomach wall and abdominal wall of a patient in order to temporarily secure the stomach wall to the abdominal wall. In particular, the present invention relates to a biological suturing device that can easily remove a suture that has been fed into the body using a suture-pulling puncture needle and held in a snare loop from the snare loop.
一般に生体用縫合装置は、例えば胃に食物を流し込むための胃瘻を内視鏡的に形成する際、患者の胃壁を腹壁に一時的に固定するために胃壁と腹壁とを縫合する場合に用いられる。従来技術による生体用縫合装置は、図9(a)他に示す患者の腹壁101と胃壁102を一時的に固定するために縫合するものであって、先端が胃内に達するように体外から穿刺されて縫合糸50を胃内に導入する縫合糸挿入用穿刺針1と、該縫合糸挿入用穿刺針1により胃内に導入した縫合糸50を胃外に引き出すための縫合糸引出用穿刺針2と、該縫合糸挿入用穿刺針1及び縫合糸引出用穿刺針2とを平行に並んだ状態で配置させるための板状の連結部材3と、長尺状の先端がループ状に形成されたスネアループ10を外方から挿脱自在な円筒状の操作ロッド20に出し入れする操作部40とを備える。 Typically, a biological suturing device is used, for example, when endoscopically forming a gastrostomy to allow food to flow into the stomach, to suture the patient's stomach wall to temporarily secure it to the abdominal wall. A conventional biological suturing device, shown in Figure 9(a) and elsewhere, is used to temporarily secure a patient's abdominal wall 101 and stomach wall 102 together. It includes a suture insertion needle 1 that is inserted from outside the body so that its tip reaches the stomach and introduces a suture 50 into the stomach, a suture withdrawal needle 2 that withdraws the suture 50 introduced into the stomach by the suture insertion needle 1, a plate-shaped connecting member 3 that positions the suture insertion needle 1 and the suture withdrawal needle 2 in parallel, and an operating unit 40 that inserts and removes a snare loop 10, whose long, loop-shaped tip is inserted and removed from a cylindrical operating rod 20 that can be inserted and removed from the outside.
前記縫合糸挿入用穿刺針1は、円筒形状であって縫合糸50を体外から体内に送り込むための内部通路が軸方向に貫通して形成され、その手元側端部に入口口金4が取り付けられている。前記縫合糸引出用穿刺針2は、円筒形状であって前記胃内に導入した縫合糸50の先端を体内から体外に引き出すための内部通路が軸方向に貫通して形成され、その手元側端部に入口口金5が取り付けられている。 The suture insertion puncture needle 1 is cylindrical and has an internal passageway passing through it in the axial direction for feeding the suture 50 from outside the body into the body, with an inlet connector 4 attached to its proximal end. The suture withdrawal puncture needle 2 is cylindrical and has an internal passageway passing through it in the axial direction for withdrawing the tip of the suture 50 introduced into the stomach from inside the body to outside the body, with an inlet connector 5 attached to its proximal end.
前記操作部40は、長尺状素材の先端側がループ状に形成されたスネアループ10と、該スネアループ10を貫通させる円筒状の操作ロッド20と、前記スネアループ10の後端側に取り付けられ、操作者が手で摘まむための摘部30とを備える。このスネアループ10は、縫合糸50の先端付近に係合させて縫合糸50を牽引するために開口したループを先端に形成した長尺状ステンレス鋼線製の単線等のような弾性ワイヤであって、その先端に縫合糸50を挟んで保持係合するための縫合糸係合部を備える。例えば、スネアループ10は、図10(a)及び(b)に示す如く、長尺状ステンレス鋼線により先端に立体的なループ形(ハート形や円形)であって先端部に突出し、スネアループ10径eと略同一内径且つ深さZのU字を形成した縫合糸係合部15を設け、胃内に挿入した状態においては胃壁及び腹壁とほぼ平行な方向(鉛直下方向に対して略垂直な方向)に延びるように成形されている。また、スネアループ10は、ループ状に形成された部分を窄めた状態に弾性変形させて縫合糸引出用穿刺針2の内部通路を通過させることができる。 The operating unit 40 comprises a snare loop 10, a long material with a loop-shaped distal end, a cylindrical operating rod 20 that passes through the snare loop 10, and a gripping portion 30 attached to the rear end of the snare loop 10 for the operator to grasp with their hand. The snare loop 10 is an elastic wire, such as a long, solid stainless steel wire, with an open loop formed at its distal end for engaging near the distal end of the suture 50 and pulling the suture 50, and is provided with a suture engaging portion at its distal end for clamping and holding the suture 50. For example, as shown in Figures 10(a) and (b), the snare loop 10 is made of a long stainless steel wire and has a three-dimensional loop shape (heart or circular) at its tip, protruding from the tip and provided with a U-shaped suture engagement portion 15 with an inner diameter substantially the same as the diameter e of the snare loop 10 and a depth Z, which is shaped so that when inserted into the stomach, it extends in a direction substantially parallel to the stomach wall and abdominal wall (a direction substantially perpendicular to the downward vertical direction). Furthermore, the snare loop 10 can be elastically deformed by narrowing the loop-shaped portion so that it can pass through the internal passage of the suture withdrawal puncture needle 2.
このように構成された生体用縫合装置は、医師が次の工程を施すことによって、胃壁と腹壁とを縫合する。
(A)腹壁101及び胃壁102に対して連結部材3により連結された縫合糸挿入用穿刺針1及び縫合糸引出用穿刺針2を体外から突き通し、縫合糸挿入用穿刺針1と縫合糸引出用穿刺針2の各先端を並んで胃内に開口させる状態とし、次いで、図9(a)に示す如く、入口口金4から縫合糸50を縫合糸挿入用穿刺針1の後端位置まで挿入すると共に、入口口金5からスネアループ10を縫合糸引出用穿刺針2に挿入し、スネアループ10のループ部分を胃壁及び腹壁とほぼ平行な方向(横方向)であって縫合糸挿入用穿刺針1側に向かって延ばした状態とさせる第1工程。
(B)前記第1工程において縫合糸引出用穿刺針2の先端からスネアループ10のループ部分を胃壁及び腹壁とほぼ平行な方向に延ばした状態において、図9(b)に示す如く、縫合糸挿入用穿刺針1から縫合糸50が縫合糸引出用穿刺針2から横方向に延びたスネアループ10のループ部分内を通すように突き出させる第2工程。
(C)図9(c)に示す如く、前記操作部40を用いてスネアループ10を縫合糸引出用穿刺針2の入口口金5から引き抜くことにより、ループ部分の端部が縫合糸50を引っ掛けて体外に引き出す第3工程。
The biological suturing device configured as above allows a doctor to suture the stomach wall and abdominal wall by carrying out the following steps.
(A) A first step in which a suture insertion puncture needle 1 and a suture withdrawal puncture needle 2 connected by a connecting member 3 are pierced from outside the body through the abdominal wall 101 and the stomach wall 102, so that the tips of the suture insertion puncture needle 1 and the suture withdrawal puncture needle 2 are lined up and open into the stomach, and then, as shown in Figure 9(a), a suture 50 is inserted from the entrance connector 4 to the rear end position of the suture insertion puncture needle 1, and a snare loop 10 is inserted from the entrance connector 5 into the suture withdrawal puncture needle 2, so that the loop portion of the snare loop 10 is extended toward the suture insertion puncture needle 1 in a direction approximately parallel to the stomach wall and abdominal wall (horizontal direction).
(B) In the first step, with the loop portion of the snare loop 10 extended from the tip of the suture withdrawal puncture needle 2 in a direction approximately parallel to the stomach wall and abdominal wall, the suture 50 is protruded from the suture insertion puncture needle 1 so as to pass through the loop portion of the snare loop 10 extending laterally from the suture withdrawal puncture needle 2, as shown in Figure 9(b).
(C) As shown in Figure 9(c), the third step is to use the operating part 40 to pull out the snare loop 10 from the inlet nozzle 5 of the suture withdrawal puncture needle 2, so that the end of the loop hooks the suture 50 and pulls it out of the body.
この第3工程における詳細は、図10(a)に示す如く、縫合糸引出用穿刺針2の下方から先端にU字形の縫合糸係合部15を有するループ形状を横方向に拡げた状態のスネアループ10の開口部に対し、縫合糸挿入用穿刺針1から縫合糸50を下方向に挿入した後、スネアループ10を引き抜くことによって、図10(b)に示す如く、縫合糸50をスネアループ10先端のU字形の縫合糸係合部15に引き込み、縫合糸50の径とほぼ同寸法eにU字開口した縫合糸係合部15に保持係合することによって引っ掛け、更にスネアループ10を縫合糸引出用穿刺針2内から引き抜くことによって行われる。
(D)次いで生体用縫合装置は、医師が縫合糸挿入用穿刺針1及び縫合糸引出用穿刺針2を体外に引き出し、縫合糸を結び合わせることにより腹壁101と胃壁102を縫合することができる。
As shown in FIG. 10( a ), the details of this third step are as follows: a suture 50 is inserted downward from the suture insertion puncture needle 1 into the opening of the snare loop 10, which has a U-shaped suture engagement portion 15 at its tip and is in a loop shape that is spread out laterally, from below the suture withdrawal puncture needle 2; and then the snare loop 10 is pulled out, so that, as shown in FIG. 10( b ), the suture 50 is drawn into the U-shaped suture engagement portion 15 at the tip of the snare loop 10, and is hooked by retaining and engaging with the suture engagement portion 15, which has a U-shaped opening with a dimension e that is approximately the same as the diameter of the suture 50; and the snare loop 10 is then pulled out from within the suture withdrawal puncture needle 2.
(D) Next, the doctor pulls out the suture insertion needle 1 and the suture withdrawal needle 2 from the body and knots the suture together, thereby suturing the abdominal wall 101 and the stomach wall 102 together.
なお、前述の生体用縫合装置に関する技術が記載された文献としては、次の特許文献1及び2が挙げられる。 Note that the following patent documents 1 and 2 are examples of documents that describe technology related to the aforementioned biological suturing device.
一般に生体用縫合装置は、前述の操作によって患者の胃壁を腹壁に一時的に固定する施術を行う際に、一旦、縫合糸係合部15に縫合糸50を保持係合した後に縫合糸50を外す必要が生じる場合があるが、特許文献1に記載された従来技術による生体用縫合装置は、縫合糸50をU字形の縫合糸係合部15に挟み込んで挟持するため、縫合糸係合部15から外す(リリース)のが困難であると言う課題があった。 Generally, when performing a procedure to temporarily fix a patient's stomach wall to the abdominal wall using the above-mentioned operation, it may be necessary to first hold and engage the suture 50 in the suture engagement portion 15 and then release the suture 50. However, the conventional biosuturing device described in Patent Document 1 clamps and holds the suture 50 in the U-shaped suture engagement portion 15, which makes it difficult to release the suture 50 from the suture engagement portion 15.
また、特許文献2に記載された生体用縫合装置は、鉛直下方向に垂らした状態のスネアループに、縫合糸と結ばれて円弧状にカーブするように形状記憶された高剛性の形状記憶ワイヤを横方向から挿入することにより縫合糸挿入用穿刺針の先端と形状記憶ワイヤとを係合把持させ、この係合させた状態の縫合糸挿入用穿刺針を引き抜くことによって形状記憶ワイヤに繋がれた縫合糸を胃外へ引き抜く技術が記載されている。この特許文献2に記載された技術は、スネアループ先端の縫合糸係合部が細線を一回転させてなるガイド部(環状部)により構成される技術が記載されているが、このガイド部は段落0038に記載されている様に縫合糸挿入用穿刺針と形状記憶合金ワイヤと係合して強固に把持するものであって、その他の作用効果については記載されていないと共に、形状記憶ワイヤを係合把持した後に外す(リリース)際の課題及び技術については示唆されてもいない。 Furthermore, the biological suturing device described in Patent Document 2 describes a technique in which a highly rigid shape-memory wire, which is tied to a suture and has been curved to form an arc, is inserted laterally into a snare loop hanging vertically downward, thereby engaging and gripping the tip of a suture insertion needle with the shape-memory wire, and then the engaged suture insertion needle is pulled out, pulling the suture connected to the shape-memory wire out of the stomach. The technology described in Patent Document 2 describes a technique in which the suture engagement portion at the tip of the snare loop is configured as a guide portion (annular portion) formed by rotating a thin wire once. However, as described in paragraph 0038, this guide portion engages with the suture insertion needle and the shape-memory alloy wire to firmly grip them. Other effects are not described, nor is there any suggestion of the challenges or techniques involved in releasing the shape-memory wire after it has been engaged and gripped.
本発明は、このような課題に鑑み、縫合糸引出用穿刺針から体内に送り込んだスネアに一旦挿入した縫合糸をスネアから容易に取り外すことができる生体用縫合装置を提供することを目的とする。 In view of these issues, the present invention aims to provide a biological suturing device that allows for easy removal of a suture from a snare that has been inserted into the body through a suture withdrawal puncture needle.
前記目的を達成するため本発明は、長尺線状の先端がループ状に形成された所定剛性を有するステンレス製単線のスネアループ及び該スネアループを挿脱自在な円筒状の操作ロッドを含む操作部と、縫合糸を体内に送り込むための内部通路が軸方向に貫通された縫合糸挿入用穿刺針と、前記縫合糸の先端を体内から引き出すための内部通路が軸方向に貫通されて前記操作ロッドが挿脱自在であって前記縫合糸挿入用穿刺針と並列に配置された縫合糸引出用穿刺針と、該縫合糸挿入用穿刺針及び縫合糸引出用穿刺針とを並んだ状態で配置させるための連結部材とを備えた生体用縫合装置であって、
前記スネアループが、前記円筒状の操作ロッドから突き出たときに前記操作ロッドの先端から鉛直下方向に対して略垂直な方向にループ形状に延び、該ループ形状の先端を交差部分が接触しない範囲で30度から180度未満の角度捩った円環状の縫合糸係合部を有し、
前記縫合糸が、前記スネアループの剛性に比べて高剛性であって、前記スネアループの縫合糸係合部に挿入された状態であって前記スネアループが操作ロッドから押し出されたとき、前記交差部分に押し込まれてスネアループの縫合糸係合部から外れるように構成したことを第1の特徴とする。
In order to achieve the above object, the present invention provides a biological suturing device comprising an operating section including a snare loop made of a single stainless steel wire having a predetermined rigidity and a long, wire-like tip formed into a loop shape, and a cylindrical operating rod into which the snare loop can be inserted and removed; a suture insertion puncture needle having an internal passage passing therethrough in the axial direction for feeding a suture into a body; a suture withdrawal puncture needle arranged in parallel to the suture insertion puncture needle and having an internal passage passing therethrough in the axial direction for withdrawing the tip of the suture from the body, and into which the operating rod can be inserted and removed; and a connecting member for arranging the suture insertion puncture needle and the suture withdrawal puncture needle side by side,
the snare loop extends in a loop shape from the tip of the operating rod in a direction substantially perpendicular to the vertically downward direction when protruding from the cylindrical operating rod, and has an annular suture engaging portion in which the tip of the loop shape is twisted at an angle of 30 degrees to less than 180 degrees within a range in which the intersecting portions do not come into contact with each other;
The first feature is that the suture has higher rigidity than the snare loop, and when the snare loop is inserted into the suture engagement portion of the snare loop and pushed out from the operating rod, the suture is pushed into the intersection portion and disengaged from the suture engagement portion of the snare loop.
また本発明は、長尺線状の先端がループ状に形成されたスネアループ及び該スネアループを挿脱自在な円筒状の操作ロッドを含む操作部と、縫合糸を体内に送り込むための内部通路が軸方向に貫通された縫合糸挿入用穿刺針と、前記縫合糸の先端を体内から引き出すための内部通路が軸方向に貫通されて前記操作ロッドが挿脱自在であって前記縫合糸挿入用穿刺針と並列に配置される縫合糸引出用穿刺針と、該縫合糸挿入用穿刺針及び縫合糸引出用穿刺針とを並んだ状態で配置させるための連結部材とを備え、
前記スネアループが、所定の第1の直径に設定されたステンレス製の単線から成り、
前記円筒状の操作ロッドから突き出たときに前記操作ロッドの先端から鉛直下方向に対して略垂直な方向にループ形状に延びるように形成された生体用縫合装置であって、
前記縫合糸が、長尺状の樹脂製の単線であって、鉛直下方向に細長い形状に垂れ下がった状態において直線形状を維持しようとする直線形状維持力を有し、該直線形状維持力が、前記スネアループの第1の直径との径差が1.5倍から5倍の範囲で大きいことによって設定され、
前記スネアループが、前記ループ形状の先端から突出して前記縫合糸の直径に比べて1.5倍から5倍の範囲の内径に設定され且つ交差部が接触しない範囲で30度から180度未満の角度捩って形成された円環状の縫合糸係合部を設けたことを第2の特徴とする。
The present invention also provides a surgical instrument comprising: an operating section including a snare loop having a long, linear tip formed into a loop shape; and a cylindrical operating rod into which the snare loop can be inserted and removed; a suture insertion puncture needle having an internal passage passing therethrough in the axial direction for feeding a suture into a body; a suture withdrawal puncture needle having an internal passage passing therethrough in the axial direction for withdrawing the tip of the suture from the body, and through which the operating rod can be inserted and removed, and arranged in parallel to the suture insertion puncture needle; and a connecting member for arranging the suture insertion puncture needle and the suture withdrawal puncture needle side by side,
the snare loop is made of a stainless steel solid wire set to a predetermined first diameter;
a biological suturing device formed so as to extend in a loop shape from a tip of the operating rod in a direction substantially perpendicular to a vertically downward direction when protruding from the cylindrical operating rod,
the suture is a long, resin-made single wire, and has a straight shape maintaining force that tends to maintain the straight shape when hanging down in an elongated shape in the vertically downward direction, and the straight shape maintaining force is set by a difference in diameter between the suture and the first diameter of the snare loop being 1.5 to 5 times larger,
The second feature of the snare loop is that it has a circular suture engaging portion that protrudes from the tip of the loop, has an inner diameter that is set to a range of 1.5 to 5 times the diameter of the suture, and is twisted at an angle of 30 degrees to less than 180 degrees so that the intersections do not come into contact.
さらに本発明は、前記第1又は第2の特徴の生体用縫合装置において、前記スネアループが、80度から100度の角度捩って形成された円環状の縫合糸係合部を設けたことを第3の特徴とし、前記第1又は第2の特徴の生体用縫合装置において、前記スネアループが、170度から180度未満の角度捩って形成された円環状の縫合糸係合部を設けたことを第4の特徴とし、前記第3の特徴の生体用縫合装置において、前記スネアループの縫合糸係合部が、前記縫合糸の直径に比べて2倍から3倍の範囲の内径に設定したことを第5の特徴とし、前記第4の特徴の生体用縫合装置において、前記スネアループの縫合糸係合部が、前記縫合糸の直径に比べて2倍から3倍の範囲の内径に設定したことを第6の特徴とする。 Furthermore, the present invention has a third feature in that, in the biological suturing device of the first or second feature, the snare loop has an annular suture engagement portion formed by a twist angle of 80 to 100 degrees; a fourth feature in that, in the biological suturing device of the first or second feature, the snare loop has an annular suture engagement portion formed by a twist angle of 170 to less than 180 degrees; a fifth feature in that, in the biological suturing device of the third feature, the suture engagement portion of the snare loop has an inner diameter set to a range of two to three times the diameter of the suture; and a sixth feature in that, in the biological suturing device of the fourth feature, the suture engagement portion of the snare loop has an inner diameter set to a range of two to three times the diameter of the suture.
本発明の第1の特徴による生体用縫合装置は、前記スネアループが操作ロッドから突き出たときに先端から鉛直下方向に対して略垂直な方向にループ形状に延び、該ループ形状の先端を交差部分が接触しないように捩った円環状の縫合糸係合部を有し、スネアループの剛性に比べて高剛性な縫合糸が、縫合糸係合部に挿入された状態においてスネアループが押し出されたとき、前記交差部分に押し込まれてスネアループの縫合糸係合部から外れるように構成したことによって、スネアに一旦挿入した縫合糸をスネアから容易に取り外すことができる。 The biological suturing device according to the first aspect of the present invention has a loop-shaped suture engagement section that extends from the tip of the snare loop in a direction approximately perpendicular to the downward vertical direction when the snare loop protrudes from the operating rod, and has a circular suture engagement section in which the tip of the loop is twisted so that the intersecting portions do not come into contact. When a suture with higher rigidity than the snare loop is inserted into the suture engagement section and the snare loop is pushed out, the suture is pushed into the intersecting portion and disengaged from the suture engagement section of the snare loop. This allows a suture that has been inserted into the snare to be easily removed from the snare.
本発明の第2の特徴による生体用縫合装置は、縫合糸が鉛直下方向に細長い形状に垂れ下がった状態において直線形状を維持しようとする直線形状維持力を有し、該直線形状維持力が、前記スネアループの第1の直径との径差が1.5倍から5倍の範囲で大きいことによって設定され、スネアループが、ループ形状の先端から突出して前記縫合糸の直径に比べて1.5倍から5倍の範囲の内径に設定され且つ交差部が接触しない範囲で30度から180度未満の角度捩って形成された円環状の縫合糸係合部を設けたことによって、
スネアに一旦挿入した縫合糸をスネアから容易に取り外すことができる。
The biological suturing device according to the second aspect of the present invention has a straightness maintaining force that tends to maintain the straightness of the suture when it is hanging down in a thin, elongated shape in the vertical direction, and this straightness maintaining force is set by a difference in diameter between the snare loop and the first diameter being 1.5 to 5 times larger, and the snare loop has an annular suture engaging portion that projects from the tip of the loop and has an inner diameter that is 1.5 to 5 times larger than the diameter of the suture, and is twisted at an angle of 30 degrees to less than 180 degrees so that the intersecting portions do not come into contact with each other,
Once inserted into the snare, the suture can be easily removed from the snare.
以下、本発明の実施形態に係る生体用縫合装置を詳細に説明する。
[生体用縫合装置の基本的構成]
本実施形態による生体用縫合装置は、図1(b)に示す如く、縫合糸50を体内に送り込むための内部通路が軸方向に貫通された縫合糸挿入用穿刺針1と、前記縫合糸50の先端を体内から引き出すための内部通路が軸方向に貫通されて前記縫合糸挿入用穿刺針1と並列に配置される縫合糸引出用穿刺針2と、該縫合糸挿入用穿刺針1及び縫合糸引出用穿刺針2とを並んだ状態で配置させるための板状の連結部材3と、長尺線状の先端がループ状に形成されたスネアループ10及び前記縫合糸引出用穿刺針2の内部通路を挿脱自在であり該スネアループ10を外方から挿脱自在な円筒状の操作ロッド20を含む操作部40とを備える。
Hereinafter, a biological suturing device according to an embodiment of the present invention will be described in detail.
[Basic configuration of the biological suturing device]
As shown in FIG. 1(b), the biological suturing device of this embodiment comprises a suture insertion puncture needle 1 having an internal passage passing axially through it for feeding a suture 50 into the body, a suture withdrawal puncture needle 2 having an internal passage passing axially through it for withdrawing the tip of the suture 50 from the body and arranged in parallel to the suture insertion puncture needle 1, a plate-like connecting member 3 for arranging the suture insertion puncture needle 1 and the suture withdrawal puncture needle 2 side by side, and an operating section 40 including a snare loop 10 having a long, linear tip formed into a loop shape and a cylindrical operating rod 20 which can be inserted and removed through the internal passage of the suture withdrawal puncture needle 2 and which can insert and remove the snare loop 10 from the outside.
該操作部40は、図1(a)に示す如く、長尺状ステンレス鋼線の先端がループ状に形成されたスネアループ10と、該スネアループ10を貫通させる円筒状の操作ロッド20と、該操作ロッド20の後端側に取り付けられ、操作者が手で摘まむための摘部30とを備える。該スネアループ10は、操作ロッド20の軸方向から見ると先端にU字形の突出部を捩った縫合糸係合部14を有する。 As shown in Figure 1(a), the operating unit 40 comprises a snare loop 10, which is a long stainless steel wire with a looped tip, a cylindrical operating rod 20 through which the snare loop 10 passes, and a grip 30 attached to the rear end of the operating rod 20 for the operator to grip with their hand. When viewed axially of the operating rod 20, the snare loop 10 has a suture engagement portion 14 at its tip, which is a twisted U-shaped protrusion.
[第1実施形態のスネアループ]
この操作部40から突き出した状態のスネアループ10は、斜視図である図2(a)及び側面図である図2(b)に示す如く、斜視から見た場合は操作ロッド20の先端から見て横方向(胃壁及び腹壁とほぼ平行な方向であって鉛直下方向に対して略垂直な方向)に延びるように成形され、先端から90度捩った方向に突出し且つ交差部分が非接触で交差する円環部を構成する縫合糸係合部14を備える。
[Snare Loop of First Embodiment]
As shown in the perspective view of Figure 2(a) and the side view of Figure 2(b), the snare loop 10 protruding from the operating portion 40 is shaped so that when viewed from an oblique angle, it extends laterally (in a direction substantially parallel to the stomach wall and abdominal wall and substantially perpendicular to the downward vertical direction) from the tip of the operating rod 20, and is provided with a suture engaging portion 14 that protrudes in a direction twisted by 90 degrees from the tip and forms a circular portion whose intersecting portions intersect without contacting each other.
すなわち、本発明の第1実施形態による生体用縫合装置のスネアループ10は、図3に示す如く、鉛直下方向に対して略垂直な方向のXY平面方向(スネアループ平面方向)に延びる大きいループ状の先端に、縫合糸50の外径に比べて約1.5~約5倍程度の内径を有するU字形の突出部をY軸中心に回転する方向に交差分が接触しないように90度捩ること(半捩り形成)により前記XY平面に対して垂直なZ方向に延び且つ交差部分が(間隔をもって)非接触で環状の縫合糸係合部14を備える。なお、縫合糸係合部14の捩り角度は、90度近傍であれば良く、80度から100度の範囲であっても良く、更に広い範囲であっても良い。 That is, as shown in Figure 3, the snare loop 10 of the biological suturing device according to the first embodiment of the present invention has a large loop-shaped tip extending in the XY plane (snare loop plane direction), which is approximately perpendicular to the downward vertical direction, and a U-shaped protrusion having an inner diameter approximately 1.5 to 5 times the outer diameter of the suture 50, twisted 90 degrees (semi-twisted) in the direction of rotation about the Y axis so that the intersecting portions do not contact each other, thereby forming an annular suture engagement portion 14 that extends in the Z direction perpendicular to the XY plane and whose intersecting portions (with a gap) do not contact each other. The twist angle of the suture engagement portion 14 may be close to 90 degrees, may be in the range of 80 to 100 degrees, or may be in an even wider range.
本実施形態によるスネアループ10は、例えば、クロム(Cr)を18.00~20.00、ニッケル(Ni)を8.00~10.50、炭素量(C)を0.080以下含み、弾性係数(弾性率)が74GPa、引張強さが1700~2500N/平方mm程度のオーステナイト系のステンレス鋼製(SUS304WP-8)の単線であって、直径(本出願では第1の直径と呼ぶ)が、例えば、0.16±0.005mmである。 The snare loop 10 according to this embodiment is a solid wire made of austenitic stainless steel (SUS304WP-8) containing, for example, 18.00 to 20.00 chromium (Cr), 8.00 to 10.50 nickel (Ni), and 0.080 or less carbon (C), with an elastic modulus (modulus of elasticity) of approximately 74 GPa and a tensile strength of approximately 1700 to 2500 N/mm2, and has a diameter (referred to as the first diameter in this application) of, for example, 0.16±0.005 mm.
このスネアループ10は、例えば直線状のステンレス鋼製の任意の位置に内径を規定するための所定径の円柱体に巻き付けて捩ることよって所定角度の捩りの形状(円環部)を形成し、次いで縫合糸50を取り込むためのループ状に成形することによって、突出したU字形をY軸を中心に回転する方向に捩った形状(スネアループ平面を捩る方向)に形成することができる。 This snare loop 10 can be formed by wrapping and twisting a linear stainless steel cylinder of a specified diameter at any position to define the inner diameter, forming a twisted shape (annular portion) at a specified angle, and then forming it into a loop to capture the suture 50. This allows the protruding U-shape to be twisted in a direction rotating around the Y-axis (the direction twisting the plane of the snare loop).
本実施形態による縫合糸50は、アミド結合の繰り返しによって主鎖を構成する熱可塑性高分子材料から形成されるポリアミド樹脂であるナイロン製であって、例えば直径が0.35mmである。このため縫合糸50は、直径が約半分以下の直径0.16mmのステンレス鋼線であるスネアループ10に比較して、鉛直下方向に線状に垂れ下がった状態において直線形状を維持しようとする力(本発明では「直線形状維持力」と呼ぶ)が、素材径と剛性の差によって大きくなるように設定される。なお、縫合糸係合部14の円環部の内径は、縫合糸50の外径(直径0.35mm)に比べて充分に大きい約1.5倍から約5倍程度が好ましく、図面では約3倍の約1mmである。 The suture 50 in this embodiment is made of nylon, a type of polyamide resin formed from a thermoplastic polymeric material whose main chain is composed of repeated amide bonds, and has a diameter of, for example, 0.35 mm. Therefore, compared to the snare loop 10, which is made of stainless steel wire with a diameter of 0.16 mm, approximately half the diameter of the snare loop, the suture 50 is designed so that the force that attempts to maintain its straight shape when hanging vertically downward (referred to as the "straight shape maintaining force" in this invention) is greater due to the difference in material diameter and rigidity. The inner diameter of the annular portion of the suture engagement portion 14 is preferably sufficiently larger, approximately 1.5 to 5 times the outer diameter of the suture 50 (0.35 mm diameter), and is approximately 3 times larger, or approximately 1 mm, in the drawings.
[縫合動作]
このように構成された本実施形態による生体用縫合装置は、図6に示す次の施術工程を施すことによって、胃壁と腹壁とを縫合する。
[Suture operation]
The biological suturing device according to this embodiment configured as described above sutures the stomach wall and abdominal wall by carrying out the following surgical steps shown in FIG.
(A)医師が、腹壁101及び胃壁102に対して連結部材3により連結された縫合糸挿入用穿刺針1及び縫合糸引出用穿刺針2を体外から腹部に突き通し、縫合糸挿入用穿刺針1及び縫合糸引出用穿刺針2の各先端を並んで胃内に開口させる状態とし、入口口金4から縫合糸50を縫合糸挿入用穿刺針1の後端位置まで挿入すると共に、入口口金5からスネアループ10を縫合糸引出用穿刺針2に挿入してスネアループ10のループ部分(縫合糸を取り込む部分)を胃壁及び腹壁とほぼ平行な方向(横方向)であって縫合糸挿入用穿刺針1側に向かってに延ばした状態とする。次いで、医師が、図6(a)に示す如く、縫合糸挿入用穿刺針1から縫合糸50を更に鉛直下方向に挿入することによって、縫合糸引出用穿刺針2から横方向に延びたスネアループ10のループ部分内に、縫合糸50を通すように矢印イ方向に突き通す第1工程。 (A) The doctor inserts the suture insertion needle 1 and the suture withdrawal needle 2, which are connected to the abdominal wall 101 and the stomach wall 102 by connecting member 3, into the abdomen from outside the body, so that the tips of the suture insertion needle 1 and the suture withdrawal needle 2 are lined up and open into the stomach. He then inserts the suture 50 through the entrance nozzle 4 to the rear end of the suture insertion needle 1, and inserts the snare loop 10 into the suture withdrawal needle 2 through the entrance nozzle 5, so that the loop portion of the snare loop 10 (the portion that takes in the suture) is extended in a direction approximately parallel to the stomach wall and abdominal wall (horizontal direction) and toward the suture insertion needle 1. Next, as shown in Figure 6(a), the doctor further inserts the suture 50 vertically downward from the suture insertion puncture needle 1, thereby passing the suture 50 through the loop portion of the snare loop 10 extending laterally from the suture withdrawal puncture needle 2 in the direction of arrow (I).
(B)次いで医師が、図6(b)に示す如く、縫合糸引出用穿刺針2に挿入した操作部40の摘まみ30を矢印ロ方向に引き抜くことにより、スネアループ10の環状部分が縫合糸挿入用穿刺針1から延びる縫合糸50を操作ロッド20の出口に向けて徐々に引き抜く第2工程。
(C)更に医師が、図6(c)に示す如く、第2工程による縫合糸50を更に引き抜くことによって、縫合糸50がスネアループ10先端に設けた半捩りした円環状の縫合糸係合部14に嵌め込んで保持係合する第3工程。
(B) Next, as shown in Figure 6(b), the doctor pulls out the knob 30 of the operating part 40 inserted into the suture withdrawal puncture needle 2 in the direction of arrow B, thereby gradually pulling out the annular part of the snare loop 10, which is the suture 50 extending from the suture insertion puncture needle 1, toward the outlet of the operating rod 20.
(C) A third step in which the doctor further pulls out the suture 50 from the second step, as shown in Figure 6(c), so that the suture 50 fits into and engages with the semi-twisted, annular suture engagement portion 14 provided at the tip of the snare loop 10.
このスネアループ10先端の縫合糸係合部14に保持係合する第3工程の詳細を、縫合糸係合部14の近傍を拡大した図8を参照して説明する。
この縫合糸係合部14に縫合糸50を保持係合する第3工程は、図8(a)に示す如く、医師がスネアループ10を矢印ト方向に引き抜くに従って、スネアループ10が矢印チ方向に移動しスネアループ10の捩り部分の交差部が操作部40の操作ロッド20の円環縁に縫合糸50が突き当たり、更にスネアループ10を引くことにより、縫合糸50が縫合糸係合部14の隙間に押し込まれる(嵌め込まれる)ように動作する。この縫合糸係合部14の隙間への嵌め込みが進行すると、本実施形態による生体用縫合装置は、縫合糸50がスネアループ10と相対的に直径・硬度・剛性差による直線形状維持力が大きいため、操作ロッド20内のスネアループ10側が回動変形し、図8(b)に示すように、縫合糸50がスネアループ10の半捩りした縫合糸係合部14の円環部内に嵌め込むように挙動する。
The third step of retaining and engaging the suture thread engaging portion 14 at the tip of the snare loop 10 will be described in detail with reference to FIG. 8, which shows an enlarged view of the vicinity of the suture thread engaging portion 14.
In the third step of holding and engaging the suture 50 with the suture engaging portion 14, as shown in Figure 8(a), as the surgeon pulls out the snare loop 10 in the direction of the arrow T, the snare loop 10 moves in the direction of the arrow H, and the intersection of the twisted portion of the snare loop 10 causes the suture 50 to hit the circular edge of the operating rod 20 of the operating portion 40, and by further pulling the snare loop 10, the suture 50 is pushed (fitted) into the gap in the suture engaging portion 14. As the suture engaging portion 14 continues to be fitted into the gap, in the biological suturing device of this embodiment, the suture 50 has a greater ability to maintain its straight shape due to differences in diameter, hardness, and rigidity compared to the snare loop 10, so the snare loop 10 side within the operating rod 20 undergoes rotational deformation, and the suture 50 behaves as if it is being fitted into the circular portion of the half-twisted suture engaging portion 14 of the snare loop 10, as shown in Figure 8(b).
このように本実施形態による生体用縫合装置は、図8(b)に示すように、スネアループ10の半捩りした縫合糸係合部14の円環部内に縫合糸50を嵌め込んで保持し、この縫合糸係合部14の内径が縫合糸径より充分に大きい(約1.5倍から5倍程度、図面では3倍程度)のため、縫合糸50が縫合糸係合部14の中に緩やかに保持され、縫合糸係合部14内において動くことができる。 As shown in Figure 8(b), the biological suturing device of this embodiment holds the suture 50 by fitting it into the circular portion of the semi-twisted suture engagement portion 14 of the snare loop 10. Because the inner diameter of the suture engagement portion 14 is sufficiently larger than the diameter of the suture (approximately 1.5 to 5 times, approximately 3 times in the drawing), the suture 50 is loosely held within the suture engagement portion 14 and can move within it.
(D)さらに医師が、この第3工程により縫合糸係合部14に縫合糸50を緩く保持係合したスネアループ10を縫合糸引出用穿刺針2内から引き抜いて縫合糸挿入用穿刺針1及び縫合糸引出用穿刺針2を体外に引き出し、縫合糸を結び合わせることにより腹壁101と胃壁102を縫合することができる。 (D) Furthermore, in this third step, the doctor can pull out the snare loop 10, which has loosely held and engaged the suture 50 in the suture engagement portion 14, from the suture withdrawal needle 2, pull out the suture insertion needle 1 and the suture withdrawal needle 2 to the outside of the body, and then tie the suture together, thereby suturing the abdominal wall 101 and the stomach wall 102.
[リリース動作]
さて、一般に生体用縫合施術においては、一旦、縫合糸係合部14に縫合糸50を保持係合した後に縫合糸50を外す(リリースする)必要が生じる場合があり、この縫合糸のリリース動作について、図7を参照して説明する。
[Release action]
Generally, in biological suturing procedures, there are cases where it becomes necessary to release (release) the suture 50 after it has been held and engaged by the suture engaging portion 14. This suture release operation will be described with reference to FIG. 7.
このリリース動作は、図6(c)に示す縫合糸50がスネアループ10の円環状の縫合糸係合部14に保持係合した状態から、医師が、図7(d)に示す如く、スネアループ10を操作ロッド20から矢印ニ方向に強く押し出すように操作する。 This release operation is performed by the surgeon forcefully pushing the snare loop 10 from the operating rod 20 in the direction of arrow D, as shown in Figure 7(d), from a state in which the suture 50 is retained and engaged with the annular suture engagement portion 14 of the snare loop 10 as shown in Figure 6(c).
本実施形態による生体用縫合装置は、このスネアループ10の強い押し出し操作により、図7(d)に示す如く、スネアループ10の縫合糸係合部14が縫合糸50の位置を通り越すように矢印ホ側に向かって押し出されることにより、縫合糸50が円環状の縫合糸係合部14の交差部分に押し込まれ、更にスネアループ10を押し出す操作によって、(1)縫合糸50が直線形状維持力により下に垂れるように直線状態を維持すること(縫合糸50がスネアループ10に比べて高剛性であること)、(2)縫合糸50がスネアループ10径内に緩やかに保持されること、(3)半捩りした縫合糸係合部14の交差部に捩り部分の隙間があることによって、縫合糸50がスネアループ10の円環状の縫合糸係合部14に保持係合した状態から交差部分に押し込まれて外れる(リリースする)ように挙動する。このリリース操作は、一度のスネアループ10の押し出しによりリリースできない場合、押し出し及び引き込みを反復することによって、直線形状維持力が強い縫合糸50が縫合糸係合部14の捩り部分に強く当たるためリリースを促進することができる。 In the biological suturing device of this embodiment, as shown in Figure 7(d), by strongly pushing out the snare loop 10, the suture engagement portion 14 of the snare loop 10 is pushed toward the arrow E so that it passes over the position of the suture 50, forcing the suture 50 into the intersection of the annular suture engagement portion 14. Further pushing out the snare loop 10 results in the following: (1) the suture 50 maintains its straight state by its linear shape-maintaining force, dangling downward (the suture 50 is more rigid than the snare loop 10); (2) the suture 50 is loosely held within the diameter of the snare loop 10; and (3) there is a gap in the twisted portion at the intersection of the semi-twisted suture engagement portion 14, causing the suture 50 to be pushed into the intersection from its retained engagement with the annular suture engagement portion 14 of the snare loop 10 and released. If the snare loop 10 cannot be released by pushing it out once, repeating the pushing and pulling operation will cause the suture 50, which has a strong ability to maintain its straight shape, to come into strong contact with the twisted part of the suture engagement portion 14, thereby facilitating release.
すなわち、従来技術においては縫合糸係合部が縫合糸をU字に強く挟持しているために縫合糸係合部から縫合糸をリリースするのが困難であったが、本実施形態による生体用縫合装置は、縫合糸係合部が縫合糸を挟持しないように緩やかに保持していると共に縫合糸50の直線形状維持力(剛性)を利用し且つ縫合糸係合部14を隙間が生じるように半捩りしているため、スネアループ10を操作ロッド20から押し出す操作によって容易にリリースすることができる。換言すれば本実施形態による生体用縫合装置は、縫合糸50がスネアループ10の剛性に比べて高剛性であって、縫合糸係合部14の円環部に挿入された状態から、縫合糸係合部14が操作ロッド2から押し出すように操作されたとき、円環部の隙間に当接して隙間に入り込み、次いで縫合糸係合部14を回動させて円環部14から外れるように構成したことによって、容易にリリースすることができる。 In other words, in prior art, the suture engaging portion tightly grips the suture in a U-shape, making it difficult to release the suture from the suture engaging portion. However, in the biological suturing device of this embodiment, the suture engaging portion gently holds the suture without pinching it, utilizes the straight shape-maintaining force (rigidity) of the suture 50, and semi-twists the suture engaging portion 14 to create a gap, allowing for easy release by pushing the snare loop 10 out of the operating rod 20. In other words, in the biological suturing device of this embodiment, the suture 50 has higher rigidity than the snare loop 10, and when the suture engaging portion 14 is inserted into the annular portion of the suture engaging portion 14 and is pushed out of the operating rod 2, it abuts against and enters the gap in the annular portion, and then the suture engaging portion 14 is rotated to disengage from the annular portion 14, allowing for easy release.
[第2実施形態のスネアループ]
前述の実施形態においては、U字形部分を半捩りした縦方向の縫合糸係合部を設ける例を説明したが、本発明による縫合糸係合部の構成はこれに限られるものではなく、U字形部分をスネアループ平面方向に交差部が接触しない範囲で180度未満近く捩った形状の縫合糸係合部を採用しても良く、この180度未満近く捩ったスネアループ10を採用した生体用縫合装置の第2実施形態を図4及び図5を参照して説明する。
[Snare Loop of Second Embodiment]
In the above-described embodiment, an example was described in which a vertical suture engagement portion was provided in which the U-shaped portion was half-twisted, but the configuration of the suture engagement portion according to the present invention is not limited to this. A suture engagement portion may be employed in which the U-shaped portion is twisted nearly 180 degrees to the extent that the intersecting portions do not come into contact in the planar direction of the snare loop. A second embodiment of a biological suturing device employing a snare loop 10 twisted nearly 180 degrees will be described with reference to FIGS. 4 and 5.
この第2実施形態のスネアループ10は、斜視図である図4(a)及び側面図である図4(b)に示す如く、斜視から見た場合は操作ロッド20の先端から見て横方向(鉛直下方向に対して略垂直な方向)に延びるように成形され、先端に縫合糸径よりも広く開口して突出したU字形部分を交差部が接触しない範囲の180度未満で180度近くまで捩って形成(略全捩り形成)した横方向(鉛直下方向に対して略垂直な方向)に延びる縫合糸係合部141とを備える。 As shown in the perspective view of Figure 4(a) and the side view of Figure 4(b), the snare loop 10 of this second embodiment is formed so that when viewed from a perspective, it extends laterally (in a direction approximately perpendicular to the downward vertical direction) from the tip of the operating rod 20. It has a suture engagement portion 141 at the tip that extends laterally (in a direction approximately perpendicular to the downward vertical direction) and is formed by twisting the protruding U-shaped portion, which opens wider than the diameter of the suture, to nearly 180 degrees (approximately full twist) within a range where the intersecting portions do not come into contact with each other.
すなわち、この第2実施形態による生体用縫合装置のスネアループ10は、先端を拡大した斜視を図示した図5に示す如く、横方向のXY平面に延びる大きいループ部の先端に、縫合糸50の外径に比べて約1.5~約3倍程度の内幅(内径)を有するU字形の突出部を交差部が接触しない範囲で180度近く(180度未満)捩って形成(略全捩り形成)した環状の縫合糸係合部141を設けるように構成している。この縫合糸係合部141のステンレス単線の捩りの交差する領域(交差部分)Eは捩りが180度近く(180度未満)捩って形成され、捩り部分のステンレス単線の交差部が接触せずに微少な間隔を開けるように構成されている。また、本実施形態によるスネアループ10及び縫合糸50の材質及び径並びに弾性係数他の特性は第1実施形態と同様である。なお、本実施形態による縫合糸係合部14の捩り角度は、交差部が接触しない程度の180度近くであれば良く、例えば170度から180度未満の範囲や、180度未満の更に広い範囲であっても良い。 That is, as shown in Figure 5, which shows an enlarged perspective view of the tip, the snare loop 10 of the biological suturing device according to this second embodiment is configured to have a ring-shaped suture engagement portion 141 at the tip of a large loop portion extending in the horizontal XY plane. The U-shaped protrusion has an inner width (inner diameter) approximately 1.5 to 3 times the outer diameter of the suture 50 and is twisted nearly 180 degrees (less than 180 degrees) so that the intersections do not touch. The intersecting region (intersection portion) E of the twisted stainless steel wire of this suture engagement portion 141 is twisted nearly 180 degrees (less than 180 degrees), so that the intersections of the twisted stainless steel wires are spaced apart without touching. Furthermore, the materials, diameters, elastic moduli, and other characteristics of the snare loop 10 and suture 50 according to this embodiment are the same as those of the first embodiment. In this embodiment, the twist angle of the suture engaging portion 14 may be close to 180 degrees so that the intersections do not come into contact, and may be in the range of 170 degrees to less than 180 degrees, or in a wider range less than 180 degrees, for example.
[第2実施形態の動作]
このように構成された第2実施形態による生体用縫合装置は、第1実施形態と同様に縫合動作及びリリース動作を行うことができる。例えば、縫合施術は、医師が、スネアループ10の引き寄せにより操作部40のロッド20の円環縁を縫合糸50に突き当て、更にスネアループ10を引き抜くことによりロッド20の円環縁が縫合糸50を押して縫合糸係合部141の微少な隙間に縫合糸50を入り込ませる(嵌め込む)工程と、ロッド20の円環縁が縫合糸50を更に押すことにより縫合糸50の直線形状維持力によってスネアループ10側を変形(回転)させ、縫合糸係合部141の微少な隙間に縫合糸50を嵌め込む工程と、次いで縫合糸係合部141に縫合糸50を保持係合したスネアループ10を引き抜いて縫合糸50を体外に引き出し、縫合糸を結び合わせることにより腹壁101と胃壁102を縫合することができる。
[Operation of the second embodiment]
The biological suturing device according to the second embodiment configured as described above can perform the suturing operation and the release operation in the same manner as the first embodiment. For example, the suturing procedure involves the steps of: a) pulling the snare loop 10 in, causing the circular edge of the rod 20 of the operating unit 40 to abut against the suture 50; b) pulling out the snare loop 10, causing the circular edge of the rod 20 to push the suture 50 and force the suture 50 into (fit) the minute gap in the suture engagement portion 141; c) the circular edge of the rod 20 further pushing the suture 50, causing the straight shape of the suture 50 to maintain its shape, thereby deforming (rotating) the snare loop 10 and fitting the suture 50 into the minute gap in the suture engagement portion 141; and d) pulling out the snare loop 10, which holds and engages the suture 50 with the suture engagement portion 141, and drawing the suture 50 out of the body; and tying the suture together, thereby suturing the abdominal wall 101 and the stomach wall 102.
また、縫合糸50のリリースは、医師が、スネアループ10を操作ロッド20から強く押し出す操作により円環状の縫合糸係合部141を縫合糸50に当てた後に、更にスネアループ10を押し出すことによって、スネアループ10に対して相対的に高剛性な縫合糸50が直線形状維持力Fにより下に垂れるように直線状態を維持し、縫合糸50を内径に緩やかに保持し且つ180度未満だけ捩った縫合糸係合部14に微少な隙間があるため、スネアループ10の縫合糸係合部141が縫合糸50を緩やかに保持した状態から縫合糸係合部141の微少隙間に押し込まれて外れるように挙動し、一度のスネアループ10の押し出しによりリリースできない場合は押し出し及び引き込みを反復することによって、リリースを促進することができる。 The suture 50 is released by the surgeon by forcefully pushing the snare loop 10 off the operating rod 20, bringing the annular suture engagement portion 141 into contact with the suture 50, and then further pushing the snare loop 10. The relatively rigid suture 50 is maintained in a straight state by the linear shape retention force F, causing it to hang downward. Because the suture 50 is loosely held within the inner diameter of the suture engagement portion 14, which is twisted less than 180 degrees, the suture engagement portion 141 of the snare loop 10 moves from a state in which it is loosely holding the suture 50 to a state in which it is pushed into the small gap in the suture engagement portion 141, causing it to release. If the snare loop 10 cannot be released by pushing it out once, repeated pushing and retracting can facilitate release.
なお、本実施形態による生体用縫合装置は、縫合糸係合部141の捩り交差部分の隙間が第1実施形態に比べて微少のため、第1の実施形態による縫合糸係合部14と比較すると相対的にリリースされづらいが、逆に縫合施術時において縫合糸係合部141から縫合糸50が微少な隙間に入り込んで外れにくく、スネアループ10を縫合糸引出用穿刺針2内からの引き抜く操作を容易にすることができる。 In addition, the biological suturing device of this embodiment has a much smaller gap at the twisted intersection of the suture engaging portion 141 than the first embodiment, making it relatively difficult to release compared to the suture engaging portion 14 of the first embodiment. However, conversely, during suturing, the suture 50 does not easily slip into the small gap from the suture engaging portion 141 and become detached, making it easier to pull out the snare loop 10 from the suture withdrawal puncture needle 2.
[他の実施形態]
前述の実施形態においては、半捩り(90度捩り)した縫合糸係合部14を設ける第1実施形態及び180度近傍まで捩った縫合糸係合部141を設ける第2実施形態を説明したが、本発明による生体用縫合装置の縫合糸係合部は前述の実施形態構造に限られるものではなく、施術に使用される縫合糸及びスネアループの材質や直径を考慮し、縫合糸の縫合糸係合部に対する嵌入容易性とリリース容易性とのバランスや医師の操作性の好みによって、捩じり角度を交差部分が接触しない範囲で例えば30度以上180度未満の範囲に設定しても良い。
Other Embodiments
In the above-described embodiments, a first embodiment is provided in which a suture engaging portion 14 is provided that is half twisted (twisted by 90 degrees), and a second embodiment is provided in which a suture engaging portion 141 is provided that is twisted to nearly 180 degrees. However, the suture engaging portion of the biological suturing device according to the present invention is not limited to the structure of the above-described embodiments. Taking into consideration the material and diameter of the suture and snare loop used in the procedure, and the balance between the ease of inserting and releasing the suture into the suture engaging portion and the physician's preference for operability, the twist angle may be set within a range where the intersecting portions do not come into contact, for example, between 30 degrees and 180 degrees.
1 縫合糸挿入用穿刺針、2 縫合糸引出用穿刺針、3 連結部材、
4 入口口金、5 入口口金、10 スネアループ、
14 縫合糸係合部、15 縫合糸係合部、20 操作ロッド、30 摘部、
40 操作部、50 縫合糸、101 腹壁、102 胃壁、141 縫合糸係合部
1 Puncture needle for inserting suture thread, 2 Puncture needle for withdrawing suture thread, 3 Connecting member,
4 entrance cap, 5 entrance cap, 10 snare loop,
14 suture thread engaging portion, 15 suture thread engaging portion, 20 operating rod, 30 picking portion,
40 Operation part, 50 Suture, 101 Abdominal wall, 102 Stomach wall, 141 Suture engagement part
Claims (6)
前記スネアループが、前記円筒状の操作ロッドから突き出たときに前記操作ロッドの先端から鉛直下方向に対して略垂直な方向にループ形状に延び、該ループ形状の先端を交差部分が接触しない範囲で30度から180度未満の角度捩った円環状の縫合糸係合部を有し、
前記縫合糸が、前記スネアループの剛性に比べて高剛性であって、前記スネアループの縫合糸係合部に挿入された状態であって前記スネアループが操作ロッドから押し出されたとき、前記交差部分に押し込まれてスネアループの縫合糸係合部から外れるように構成した生体用縫合装置。 a suture insertion needle having an internal passage passing therethrough in the axial direction for feeding a suture into a body; a suture withdrawal needle arranged in parallel to the suture insertion needle, and having an internal passage passing therethrough in the axial direction for withdrawing the tip of the suture from the body, and through which the operation rod can be inserted and removed; and a connecting member for arranging the suture insertion needle and the suture withdrawal needle side by side,
the snare loop extends in a loop shape from the tip of the operating rod in a direction substantially perpendicular to the vertically downward direction when protruding from the cylindrical operating rod, and has an annular suture engaging portion in which the tip of the loop shape is twisted at an angle of 30 degrees to less than 180 degrees within a range in which the intersecting portions do not come into contact with each other;
The suture thread has a higher rigidity than the snare loop, and when the snare loop is pushed out from the operating rod while inserted into the suture thread engagement portion of the snare loop, the suture thread is pushed into the intersection portion and disengaged from the suture thread engagement portion of the snare loop.
前記スネアループが、所定の第1の直径に設定されたステンレス製の単線から成り、
前記円筒状の操作ロッドから突き出たときに前記操作ロッドの先端から鉛直下方向に対して略垂直な方向にループ形状に延びるように形成された生体用縫合装置であって、
前記縫合糸が、長尺状の樹脂製の単線であって、鉛直下方向に細長い形状に垂れ下がった状態において直線形状を維持しようとする直線形状維持力を有し、該直線形状維持力が、前記スネアループの第1の直径との径差が1.5倍から5倍の範囲で大きいことによって設定され、
前記スネアループが、前記ループ形状の先端から突出して前記縫合糸の直径に比べて1.5倍から5倍の範囲の内径に設定され且つ交差部が接触しない範囲で30度から180度未満の角度捩って形成された円環状の縫合糸係合部を設けた生体用縫合装置。 the suture insertion needle has an internal passage passing therethrough in the axial direction for feeding the suture into the body; the suture withdrawal needle has an internal passage passing therethrough in the axial direction for withdrawing the tip of the suture from the body, and the operating rod is insertable and detachable therethrough, and the suture insertion needle is disposed in parallel to the suture insertion needle; and a connecting member for arranging the suture insertion needle and the suture withdrawal needle side by side,
the snare loop is made of a stainless steel solid wire set to a predetermined first diameter;
a biological suturing device formed so as to extend in a loop shape from a tip of the operating rod in a direction substantially perpendicular to a vertically downward direction when protruding from the cylindrical operating rod,
the suture is a long, resin-made single wire, and has a straight shape maintaining force that tends to maintain the straight shape when hanging down in an elongated shape in the vertically downward direction, and the straight shape maintaining force is set by a difference in diameter between the suture and the first diameter of the snare loop being 1.5 to 5 times larger,
The snare loop protrudes from the tip of the loop shape and has an inner diameter set to a range of 1.5 to 5 times the diameter of the suture thread, and has a circular suture thread engagement portion formed by twisting at an angle of 30 degrees to less than 180 degrees so that the intersections do not come into contact.
5. The biological suturing device according to claim 4, wherein the inner diameter of the suture engaging portion of the snare loop is set to be two to three times the diameter of the suture.
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