JP6661188B2

JP6661188B2 - Suture device

Info

Publication number: JP6661188B2
Application number: JP2015156825A
Authority: JP
Inventors: 喜隆森本; 伊藤　透; 透伊藤; 秀一北方
Original assignee: Kanazawa Institute of Technology (KIT); Kanazawa Medical University
Current assignee: Kanazawa Institute of Technology (KIT); Kanazawa Medical University
Priority date: 2014-08-14
Filing date: 2015-08-07
Publication date: 2020-03-11
Anticipated expiration: 2035-08-07
Also published as: JP2016041244A

Description

本発明は、腹部の切開を必要としない内視鏡的処置術に用いる小型且つ操作性が高い縫合装置に関する。
The present invention is compact and operability used endoscopic procedures surgery that does not require incision of the abdomen about the high sewing equipment.

外科手術は大きく分けて拡大手術と縮小手術の二つに分けられる。拡大手術は患者の体表を切り開いて患部を治療する従来の手術方式である。
近年では医療機器の進歩に伴い、患者の術後の生活の質（QOL：クオリティ・オブ・ライフ）を重要視し始めており、現在では縮小手術（低侵襲手術）の方が増えてきている。低侵襲手術は内視鏡を用いた手術方式であり、体表の切開面積が拡大手術よりも小さいため、侵襲が比較的小さいとされている。ただし、手術内容は従来の拡大手術とほとんど変わらない。また、医師により熟練度が異なるため、必ずしも拡大手術より低侵襲であるとはいえない。 Surgery can be broadly divided into two categories: enlargement surgery and reduction surgery. The extended operation is a conventional operation method in which a patient's body is cut open to treat an affected part.
In recent years, with the advancement of medical equipment, the quality of life (QOL) of patients after surgery has begun to be emphasized, and at present, reduction surgery (minimally invasive surgery) is increasing. Minimally invasive surgery is an operation method using an endoscope, and the invasion area of the body surface is smaller than that of the enlargement operation, so that the invasion is relatively small. However, the contents of the operation are almost the same as those of the conventional enlarged operation. In addition, since the degree of skill varies from doctor to doctor, it is not necessarily less invasive than extended surgery.

代表的な低侵襲手術として、腹腔鏡手術と内視鏡的処置術があげられる。腹腔鏡手術は拡大手術よりも切開面積が小さいため患者への負担を軽減できる。しかし、医療機器を操作して拡大手術とほぼ同じ内容の手術を行うため手術時間が長くなる。当然、手術時間が長いほど患者への負担も大きくなり、従来の手術よりも劣る場合もある。その中でも特に影響が大きいのは縫合である。小さな針を患部に通して掴み直す動作は、処置具越しでは難しい作業であるため、従来の手術と比較すると大きな時間を要する。
内視鏡的処置術では口から内視鏡を挿入して手術を行うため、体表に傷を作らず、腹腔鏡手術よりも低侵襲性に優れ、外的ストレスも少ない。しかし、小さな腫瘍しか取り除けないという短所がある。その原因は現状では縫合する方法が無いことにある。大きな腫瘍の場合、縫合を行えない内視鏡的処置術では切除できない。治療するには別の手術に移行する必要があり、その結果、手術時間の延長もしくは手術回数の増加となり、身体への負担はより大きくなる。 Representative minimally invasive surgery includes laparoscopic surgery and endoscopic surgery. Laparoscopic surgery can reduce the burden on the patient because the incision area is smaller than that of enlarged surgery. However, the operation time is long because the operation of the medical device is performed to perform the operation having almost the same contents as the enlarged operation. Naturally, the longer the operation time, the greater the burden on the patient and may be inferior to conventional surgery. Among them, suturing is particularly significant. The operation of re-gripping a small needle through the affected part is a difficult task through a treatment tool, and therefore requires a longer time than conventional surgery.
In the endoscopic procedure, since the operation is performed by inserting an endoscope from the mouth, the wound is not made on the body surface, is less invasive than laparoscopic surgery, and has less external stress. However, it has the disadvantage that only small tumors can be removed. The cause is that there is no suturing method at present. Large tumors cannot be removed by endoscopic procedures that cannot be sutured. It is necessary to transfer to another operation for treatment, and as a result, the operation time is increased or the number of operations is increased, and the burden on the body is increased.

従来の縫合装置として例えば特許文献1には、組織を穿孔する様に設定された縫合用の曲針と、縫合糸を係合する様に前記針上に配設される針スリットと、針が組織を穿孔後、縫合糸の少なくとも一部を回収するために縫合装置の遠位端側面に配設された捕捉装置と、可撓性コイルに配設され、針を操作する様に設計されたワイヤとを具備する内視鏡用縫合器が開示されている。 As a conventional suturing device, for example, Patent Document 1 discloses a curved needle for suturing set to pierce tissue, a needle slit disposed on the needle to engage a suture, and a needle. After piercing the tissue, a capture device disposed on the distal end side of the suturing device to retrieve at least a portion of the suture, and a flexible coil disposed to manipulate the needle. An endoscope suturing device including a wire is disclosed.

特開2009-178568号公報JP 2009-178568 A

ところが、上記従来技術では以下のような問題があった。
すなわち、針と縫合糸とが別体の構成になっており、2本の縫合糸の端部を把持しながらノット（結び目）を作って胃壁等の組織を縫合していくという複雑な作業を、内視鏡で監視しながら進めていく必要があるため、縫合作業が複雑且つ時間を要するという問題があった。また、装置が比較的大型になり、患者に負担が掛かるという問題もあった。 However, the conventional technique has the following problems.
In other words, the needle and the suture are separate components, and the complicated work of forming a knot (knot) and suturing tissues such as the stomach wall while grasping the ends of the two sutures is performed. However, there is a problem that the suturing operation is complicated and time-consuming because it is necessary to proceed while monitoring with an endoscope. In addition, there is a problem that the device becomes relatively large and a burden is imposed on the patient.

本発明はこのような問題に鑑み、腹部の切開を必要としない内視鏡的処置術に用いる小型且つ操作性が高い縫合装置を提供することを課題とする。
The present invention has been made in view of such problems, it is an object of the invention to provide a compact and high operability suturing equipment used in endoscopic procedures surgery that does not require incision of the abdomen.

本発明の縫合装置は、下端部が基台に連結されていて上端部から縫合糸を押し出す押出機構と、下端部が前記基台に連結されていて上端部から前記縫合糸を引き込む引込機構とを備えており、前記押出機構及び引込機構はそれぞれ少なくとも第1リンク部材、第2リンク部材及び糸保持部から構成されており、前記第1リンク部材は、前記第１リンク部材の下端の第1関節部において前記基台に対して回転可能に軸支されると共に前記第１リンク部材の上端の第2関節部において前記第2リンク部材に対して相対的に回転可能に軸支されており、前記糸保持部は前記縫合糸を保持した状態で前記第2リンク部材の長手方向に沿って移動可能に支持されていることを特徴とする。
また、前記糸保持部は、前記縫合糸が挿入される開口部を有する糸保持部本体と、U字状のパイプと、パイプ内に挿入される複数のボールと、パイプの一方の端部に挿入されて第1ロッドの下端において前記ボールと接触する前記第１ロッドと、パイプの他方の端部に挿入されて第2ロッドの下端において前記ボールと接触すると共に前記第2ロッドの上端において前記糸保持部本体に接合される前記第2ロッドと、前記第1ロッドを下方に引っ張る第1ワイヤと、前記第2ロッドを下方に引っ張る第2ワイヤとを備えており、前記第1ワイヤを下方に引っ張ることで前記第1ロッドが前記パイプ内を下方に移動し、当該第1ロッドに押された前記複数のボールが前記パイプ内を移動することで、前記第2ロッドが前記パイプ内を上方に移動し、これにより前記糸保持部本体が前記縫合糸を保持した状態で前記第2リンク部材の長手方向に沿って上方に移動することを特徴とする。
A suturing device of the present invention includes a pushing mechanism in which a lower end is connected to a base and pushes out a suture from an upper end, and a pull-in mechanism in which a lower end is connected to the base and draws the suture from an upper end. The push-out mechanism and the pull-in mechanism each include at least a first link member, a second link member, and a yarn holding section, and the first link member is a first link member at a lower end of the first link member . At the joint part, it is rotatably supported with respect to the base, and at the second joint part at the upper end of the first link member, it is rotatably supported with respect to the second link member, The yarn holding portion is supported so as to be movable along the longitudinal direction of the second link member while holding the suture.
Further, the thread holding portion has a thread holding portion main body having an opening into which the suture is inserted, a U-shaped pipe, a plurality of balls inserted into the pipe, and one end of the pipe. The first rod, which is inserted and comes into contact with the ball at the lower end of the first rod, and is inserted into the other end of the pipe and makes contact with the ball at the lower end of the second rod, and at the upper end of the second rod, The second rod joined to the yarn holding portion main body, a first wire that pulls the first rod downward, and a second wire that pulls the second rod downward. The first rod moves downward in the pipe by pulling, and the plurality of balls pushed by the first rod move in the pipe, so that the second rod moves upward in the pipe. Move to the It is characterized in that the thread holding portion main body moves upward along the longitudinal direction of the second link member while holding the suture.

また、前記縫合糸は、前記縫合糸の先端に針を備えており、前記縫合糸の中間に先端から後端に向かって拡径するコマを連続させてなる段付き部を備えており、前記縫合糸の後端に当該縫合糸自身が挿入されることで前記段付き部で締結される締結部を備えていることを特徴とする。
また、前記縫合糸が生体内で吸収される材料からなることを特徴とする。
また、前記縫合糸の針がポリ乳酸からなり、コマがポリカプロラクトンからなることを特徴とする。
また、縫合作業開始時点において、前記針は前記押出機構の第2リンク部材の上端に位置しており、前記段付き部は前記押出機構の糸保持部及び前記引込機構の糸保持部に保持されており、前記締結部は前記引込機構の第2リンク部材の上端に位置しており、前記押出機構の第2リンク部材と、前記引込機構の第2リンク部材の上端同士を対向させた状態で、押出機構から順次押し出される縫合糸を引込機構が順次引き込むことで縫合糸を環状に形成し、前記締結部において固定することを特徴とする。
Further, the suture has a needle at the tip of the suture, and has a stepped portion formed by continuously extending a piece whose diameter increases from a tip to a rear end in the middle of the suture. It is characterized by comprising a fastening portion which is fastened at the stepped portion by inserting the suture itself into the rear end of the suture .
Further, the suture is made of a material that can be absorbed in a living body.
Further, the needle of the suture is made of polylactic acid, and the coma is made of polycaprolactone.
At the start of the suturing operation, the needle is located at the upper end of the second link member of the pushing mechanism, and the stepped portion is held by the thread holding section of the pushing mechanism and the thread holding section of the pull-in mechanism. The fastening portion is located at the upper end of the second link member of the retracting mechanism, and the second link member of the pushing mechanism and the upper end of the second link member of the retracting mechanism face each other. The pull-in mechanism sequentially pulls in the sutures sequentially extruded from the push-out mechanism, so that the sutures are formed in an annular shape and fixed at the fastening portion.

本発明の縫合装置は、押出機構と引込機構がほぼ同一の構造を備えるため、装置全体を小型化することができる。
また、縫合糸の押出動作及び引込動作を、ワイヤを引っ張る動作だけで行うことができるので、縫合作業を簡略化でき、また、作業時間の短縮にも貢献できる。
また、縫合糸が針と糸の両方の機能を兼ね備えているので、縫合作業を簡略化できる。また、段付き部を備えることで縫合糸が挿入方向と反対の方向に移動し難くすることができ、作業効率を向上できる。
また、縫合糸を生体内で吸収される材料で形成することにすれば、抜糸作業が不要となり、患者の負担を軽減できる。
また、縫合糸の針をポリ乳酸、コマをポリカプロラクトンで形成する場合、針が固く、段付き部が柔らかくなる。針を固くすることで胃壁等の縫合対象物に縫合糸を貫通させ易くできると共に、縫合終了後に針部分だけを折って切断し、除去し易くなる利点がある。また、段付き部を柔らかくすることで縫合糸を環状に変形させ易くなると共にその径を容易に小さくできる利点がある。 In the suturing device of the present invention, since the pushing mechanism and the retracting mechanism have substantially the same structure, the entire device can be reduced in size.
Further, since the operation of pushing out and pulling in the suture can be performed only by the operation of pulling the wire, the suturing operation can be simplified and the operation time can be reduced.
Further, since the suture has both functions of the needle and the thread, the suturing operation can be simplified. Further, the provision of the stepped portion makes it difficult for the suture to move in the direction opposite to the insertion direction, thereby improving the working efficiency.
In addition, if the suture is formed of a material that can be absorbed in the living body, the thread removal operation becomes unnecessary, and the burden on the patient can be reduced.
When the suture needle is formed of polylactic acid and the coma is formed of polycaprolactone, the needle is hard and the stepped portion is soft. By stiffening the needle, there is an advantage that the suture can be easily penetrated into an object to be sutured such as the stomach wall, and after the suturing is completed, only the needle portion is cut off and easily removed. In addition, by making the stepped portion soft, there is an advantage that the suture can be easily deformed in a ring shape and its diameter can be easily reduced.

縫合装置の外観を示す図(a)及び（b）Figures (a) and (b) showing the appearance of a suturing device 縫合装置の内部構造を示す図Figure showing the internal structure of the suturing device 縫合糸の構造を示す図(a)〜（d）Figures (a)-(d) showing the structure of the suture 第1リンク部材の構造示す図Diagram showing the structure of the first link member 第1リンク部材の構造示す図Diagram showing the structure of the first link member 第1リンク部材の構造示す図Diagram showing the structure of the first link member 第2リンク部材の構造示す図Diagram showing the structure of the second link member 第2リンク部材の構造示す図Diagram showing the structure of the second link member 第2リンク部材の構造示す図Diagram showing the structure of the second link member 糸保持部の構造を示す断面図Sectional view showing the structure of the yarn holding section 糸保持部の構造を示す斜視図(a)及び断面図(b)A perspective view (a) and a cross-sectional view (b) showing the structure of the yarn holding section. 糸保持部の構造を示す断面図Sectional view showing the structure of the yarn holding section 糸保持部の構造を示す断面図Sectional view showing the structure of the yarn holding section 縫合装置の動作を示す模式図Schematic view showing the operation of the suturing device 縫合装置の動作を示す模式図Schematic view showing the operation of the suturing device 縫合装置の動作を示す模式図Schematic view showing the operation of the suturing device 縫合装置の動作を示す模式図Schematic view showing the operation of the suturing device 縫合装置の動作を示す模式図Schematic view showing the operation of the suturing device 縫合装置の動作を示す模式図Schematic view showing the operation of the suturing device 縫合装置の動作を示す模式図Schematic view showing the operation of the suturing device 縫合装置の動作を示す模式図Schematic view showing the operation of the suturing device 縫合装置の動作を示す模式図Schematic view showing the operation of the suturing device 縫合装置の動作を示す模式図Schematic view showing the operation of the suturing device 縫合装置の動作を示す模式図Schematic view showing the operation of the suturing device 縫合装置の動作を示す模式図Schematic view showing the operation of the suturing device 縫合装置の動作を示す模式図Schematic view showing the operation of the suturing device 実施例1において縫合糸の成形に使用した金型を示す図FIG. 3 is a diagram showing a mold used for forming a suture in Example 1. 成形時の時間と温度の関係を示すグラフGraph showing the relationship between molding time and temperature コマの寸法を示す図Diagram showing top dimensions 引張強度試験を説明するための図Diagram for explaining tensile strength test 引張強度試験の結果を示すグラフGraph showing results of tensile strength test 正送り試験を説明するための図Diagram for explaining forward feed test 正送り試験の結果を示すグラフGraph showing the results of the forward feed test 逆送り試験を説明するための図Diagram for explaining the reverse feed test 逆送り試験の結果を示すグラフGraph showing the results of the reverse feed test 試験結果をまとめた表（a）及びJISの医療用絹製縫合糸の基準を示す表(b)Table (a) summarizing the test results and Table (b) indicating the standards for medical silk sutures of JIS 実施例2の縫合糸を示す図The figure which shows the suture of Example 2. 3種類の縫合糸の引張強度試験の結果を示すグラフGraph showing results of tensile strength test of three types of sutures 縫合糸を豚の胃壁に縫合した状態を示す図Diagram showing sutures sewn to pig stomach wall

本発明の縫合装置1の実施の形態について図面を参照しながら説明する。
図1及び図2に示すように縫合装置1は縫合糸10、基台20、押出機構30及び引込機構40から概略構成される。図1（a）に示した状態において縫合装置1の寸法は例えば直径が6mm、高さが32mm程度と従来の縫合装置と比較して小型化することができる。
基台20、押出機構30及び引込機構40は金属材料又は樹脂材料で構成される。金属材料としては例えば、ステンレス、アルミニウム、チタニウム等が挙げられ、樹脂材料としては例えばPEEK、ポリカーボネイト、ポリサルフォン等が挙げられるが、これらに限定されるものではない。
図3（a）〜（d）に示すように縫合糸10はその先端に針11を備えており、その中間に先端から後端に向かって拡径するコマ12を連続的に形成した段付き部13を備えており、その後端に締結部14を備えている。
縫合糸10は生体内で吸収される材料で形成されており、例えば生分解性プラスチックとして知られるポリ乳酸等を用いるのが好ましい。
締結部14の内面はコマ12の形状に対応して前方から後方に向かって縮径するように形成されている。針11の先端を締結部14の前方から後方に挿入していくことで、縫合糸10は段付き部13において段階的に係止され、これにより縫合糸10を環状に締結する仕組みになっている。締結部14によって縫合糸10は挿入方向と反対方向には移動し難い（締結部14から抜け出し難い）構造になっている。 An embodiment of the suturing device 1 of the present invention will be described with reference to the drawings.
As shown in FIGS. 1 and 2, the suturing device 1 is schematically composed of a suture thread 10, a base 20, an extrusion mechanism 30, and a retraction mechanism 40. In the state shown in FIG. 1A, the size of the suturing device 1 is, for example, about 6 mm in diameter and about 32 mm in height, which can be reduced in size as compared with a conventional suturing apparatus.
The base 20, the pushing mechanism 30, and the retracting mechanism 40 are made of a metal material or a resin material. Examples of the metal material include stainless steel, aluminum, and titanium, and examples of the resin material include PEEK, polycarbonate, and polysulfone, but are not limited thereto.
As shown in FIGS. 3 (a) to 3 (d), the suture 10 has a needle 11 at its distal end, and a step 12 in which a top 12 whose diameter increases from the distal end to the rear end is continuously formed in the middle thereof. And a fastening portion 14 at the rear end.
The suture 10 is formed of a material that can be absorbed in a living body. For example, it is preferable to use, for example, polylactic acid known as a biodegradable plastic.
The inner surface of the fastening portion 14 is formed so as to decrease in diameter from the front to the rear corresponding to the shape of the top 12. By inserting the distal end of the needle 11 from the front to the rear of the fastening portion 14, the suture 10 is gradually locked at the stepped portion 13, so that the suture 10 is fastened in a ring shape. I have. The fastening portion 14 has a structure in which the suture 10 is difficult to move in the direction opposite to the insertion direction (hard to slip out of the fastening portion 14).

基台20はその表面に押出機構30及び引込機構40を連結するための土台となる部材である。図示は省略するが、基台20の下側にはチューブが接続されており、当該チューブ内に後述するワイヤ等が挿入されて作業者の手元に至るようになっている。
押出機構30はその下端部が基台20に連結されており、その上端部から縫合糸10を外側に押し出すために設けられる。
なお、押出機構30と引込機構40の構造はほぼ同様であり、以下、引込機構40の図を用いて説明する場合がある。
押出機構30は、具体的には第1リンク部材31、第2リンク部材32及び糸保持部33から構成されている。
第1リンク部材31は本実施の形態では2本の柱状部材で構成されており、その下端の第1関節部34において基台20に対して回転可能に軸支されている。
第1リンク部材31を第1関節部34を中心にして回転させるための機構については周知の技術を使用すればよいため詳細な説明は省略するが、例えば図4〜図6に示すように第1リンク部材31の下端に左右方向に沿った円弧状の案内環35を設ける。また、基台20に対して上下動可能に支持した第1のT字状部材36の上辺の一部に凸部37を設け、当該凸部37を案内環35の内部に位置させる。そして、第1のT字状部材36を上方に移動させることで凸部37が案内環35の内部を摺動していき、当該凸部37の外力を受けて第1リンク部材31が第1関節部34を中心にして回転する（開く）構成を採用できる。第1リンク部材31を閉じる場合には第1のT字状部材36を下方に移動させればよい。
なお、第1リンク部材31はその上端の第2関節部38において第2リンク部材32に対して相対的に回転可能に軸支されているので、第1リンク部材31の回転動作に伴って第2リンク部材32も移動することになる。 The base 20 is a member serving as a base for connecting the extrusion mechanism 30 and the retraction mechanism 40 to the surface thereof. Although illustration is omitted, a tube is connected to the lower side of the base 20, and a wire or the like to be described later is inserted into the tube to reach the operator.
The pushing mechanism 30 has a lower end connected to the base 20, and is provided to push the suture 10 outward from the upper end.
Note that the structures of the pushing mechanism 30 and the retracting mechanism 40 are substantially the same, and may be described below with reference to the drawing of the retracting mechanism 40.
The pushing mechanism 30 specifically includes a first link member 31, a second link member 32, and a yarn holding portion 33.
In the present embodiment, the first link member 31 is composed of two columnar members, and is rotatably supported on the base 20 at the first joint portion 34 at the lower end thereof.
A well-known technique may be used for a mechanism for rotating the first link member 31 about the first joint portion 34, and thus detailed description is omitted, but for example, as shown in FIGS. An arcuate guide ring 35 extending in the left-right direction is provided at the lower end of one link member 31. In addition, a convex portion 37 is provided on a part of the upper side of the first T-shaped member 36 supported to be vertically movable with respect to the base 20, and the convex portion 37 is positioned inside the guide ring 35. Then, by moving the first T-shaped member 36 upward, the convex portion 37 slides inside the guide ring 35, and the external force of the convex portion 37 causes the first link member 31 to move to the first link member 31. A configuration of rotating (opening) around the joint 34 can be adopted. When closing the first link member 31, the first T-shaped member 36 may be moved downward.
Since the first link member 31 is rotatably supported at the upper end of the second joint portion 38 relative to the second link member 32, the first link member 31 is rotated with the rotation of the first link member 31. The two link members 32 also move.

第2リンク部材32は本実施の形態では2本の円柱で構成されており、その下端は第2関節部38において軸支されると共にその上端同士は接合されている。
第2リンク部材32を第2関節部38を中心にして回転させるための機構についても周知の技術を使用すればよいため詳細な説明は省略するが、例えば図7〜図9に示すように第1リンク部材31の2本の柱状部材の内側面に溝31aを設けておき、当該溝31aの内部を摺動する第2のT字状部材39の上辺を当該溝31aに嵌め込むと共に第2のT字状部材39の下端を第2リンク部材32の下端に軸支しておく。そして、第2のT字状部材39を下方に移動させることで、第2のT字状部材39の上辺が溝31aの内部を摺動していき、第2のT字状部材39の下端に引っ張られた第2リンク部材32が第2関節部38において屈曲する構成を採用できる。第2リンク部材32を伸ばす（屈曲を解除する）場合には第2のT字状部材39を上方に移動させればよい。 In the present embodiment, the second link member 32 is formed of two cylinders, the lower end of which is pivotally supported by the second joint 38, and the upper ends of which are joined.
Although a well-known technique may be used for a mechanism for rotating the second link member 32 about the second joint portion 38, a detailed description thereof will be omitted, but for example, as shown in FIGS. A groove 31a is provided on the inner surface of the two columnar members of the one link member 31, and the upper side of the second T-shaped member 39 sliding inside the groove 31a is fitted into the groove 31a and the second The lower end of the T-shaped member 39 is pivotally supported on the lower end of the second link member 32. Then, by moving the second T-shaped member 39 downward, the upper side of the second T-shaped member 39 slides inside the groove 31a, and the lower end of the second T-shaped member 39 A configuration in which the second link member 32 pulled by the second joint portion 38 is bent at the second joint portion 38 can be adopted. When extending the second link member 32 (releasing the bending), the second T-shaped member 39 may be moved upward.

糸保持部33は縫合糸10を保持した状態で第2リンク部材32の長手方向に沿って移動可能となるように支持されている。
具体的には、図10及び図11に示すように糸保持部33は糸保持部本体33a、パイプ33b、複数のボール33c、第1ロッド33d、第2ロッド33e、第1ワイヤ33f及び第2ワイヤ33gから構成されている。第1ワイヤ33f及び第2ワイヤ33gは第2リンク部材32及び第1リンク部材31に沿って配置され、基台20からチューブ内を通って作業者の手元に至る。
糸保持部本体33aは縫合糸10が挿入される半円形の開口部33hを有する。「半円形」とは、円形の開口の側面の一部が切り取られていることを意味する。
糸保持部本体33aは第2リンク部材32の2本の円柱が挿入される開口部33iも備えており、これによって糸保持部本体33aが第2リンク部材32の長手方向に沿って移動可能な構造になっている。
半円形の開口部33hの内面は、縫合糸10が挿入方向（押出方向）へは移動容易であり且つ挿入方向と反対方向へは移動し難くなるようにコマ12の形状に対応した縮径構造を備えている。
パイプ33bはその下側が屈曲したU字状に形成されており、第2リンク部材32の2本の円柱の間に配置された状態で当該屈曲箇所において上記第2関節部38に固定されている。
ボール33cはパイプ33b内に挿入される金属製の球体であり、少なくともパイプ33bの屈曲箇所全体に及ぶ程度の数が挿入される。 The thread holding portion 33 is supported so as to be movable along the longitudinal direction of the second link member 32 while holding the suture 10.
Specifically, as shown in FIG. 10 and FIG. 11, the yarn holding portion 33 includes a yarn holding portion main body 33a, a pipe 33b, a plurality of balls 33c, a first rod 33d, a second rod 33e, a first wire 33f, and a second wire 33f. It is composed of a wire 33g. The first wire 33f and the second wire 33g are arranged along the second link member 32 and the first link member 31, and reach from the base 20 to the operator through the inside of the tube.
The thread holding portion main body 33a has a semicircular opening 33h into which the suture 10 is inserted. “Semicircular” means that a part of the side surface of the circular opening is cut off.
The thread holder main body 33a also has an opening 33i into which the two cylinders of the second link member 32 are inserted, whereby the thread holder main body 33a can move along the longitudinal direction of the second link member 32. It has a structure.
The inner surface of the semicircular opening 33h has a reduced diameter structure corresponding to the shape of the top 12 so that the suture 10 can easily move in the insertion direction (extrusion direction) and hardly move in the direction opposite to the insertion direction. It has.
The pipe 33b is formed in a U-shape whose lower side is bent, and is fixed to the second joint portion 38 at the bent portion in a state where the pipe 33b is disposed between the two cylinders of the second link member 32. .
The balls 33c are metal spheres inserted into the pipe 33b, and the number of the balls 33c is at least as large as the whole of the bent portion of the pipe 33b.

第1ロッド33dは、パイプ33bの一方の端部（本実施の形態では右側）に挿入される棒状部材である。第1ロッド33dはその下端においてボール33cと接触すると共に第1ワイヤ33fが接続され、第1ワイヤ33fを下方に引っ張ることでパイプ33bの右側の内部を下方に移動するようになっている。
第2ロッド33eは、パイプ33bの他方の端部（本実施の形態では左側）に挿入される棒状部材である。第2ロッド33eはその下端においてボール33cと接触すると共にその上端において糸保持部本体33aに接合される。第2ロッド33eの下端には第2ワイヤ33gが接続されており、第2ワイヤ33gを下方に引っ張ることでパイプ33bの左側の内部を下方に移動するようになっている。 The first rod 33d is a rod-shaped member inserted into one end (the right side in the present embodiment) of the pipe 33b. The lower end of the first rod 33d contacts the ball 33c and is connected to the first wire 33f. The first rod 33d moves downward inside the right side of the pipe 33b by pulling the first wire 33f downward.
The second rod 33e is a rod-shaped member inserted into the other end (the left side in the present embodiment) of the pipe 33b. The lower end of the second rod 33e is in contact with the ball 33c and is joined at its upper end to the main body 33a. A second wire 33g is connected to the lower end of the second rod 33e, and moves downward inside the left side of the pipe 33b by pulling the second wire 33g downward.

次に、押出機構30単体の動作について説明する。
糸保持部本体33aの半円形の開口部33hには、その下方から上方に向かって縫合糸10が挿入されており、これにより糸保持部33は縫合糸10を保持している。
この状態から図12に示すように第1ワイヤ33fを下方に引っ張ると第1ロッド33dがパイプ33bの右側の内部を下方に移動していき、当該第1ロッド33dに押された最も右側のボール33cから順に各ボール33cがパイプ33b内の屈曲箇所を左方向に移動していく。そして、図13に示すように最も左側に位置するボール33cによって第2ロッド33eは上方に押し上げられ、糸保持部本体33aは縫合糸10を保持した状態で、第2リンク部材32の2本の円柱に案内されながら長手方向に沿って上方に移動する。そして、第2リンク部材32の上端部から縫合糸10が押し出されることで一回の押出動作が完了する。 Next, the operation of the pushing mechanism 30 alone will be described.
The suture 10 is inserted upward from below into the semicircular opening 33h of the thread holding unit main body 33a, and the thread holding unit 33 holds the suture 10.
When the first wire 33f is pulled downward from this state as shown in FIG. 12, the first rod 33d moves downward inside the right side of the pipe 33b, and the rightmost ball pushed by the first rod 33d. Each ball 33c moves leftward at the bent portion in the pipe 33b in order from 33c. Then, as shown in FIG. 13, the second rod 33e is pushed upward by the ball 33c located on the leftmost side, and the thread holding portion main body 33a holds the suture 10, and the two link members 32 of the second link member 32 are held. It moves upward along the longitudinal direction while being guided by the cylinder. Then, when the suture thread 10 is pushed out from the upper end of the second link member 32, one pushing operation is completed.

引込機構40は、その下端部が基台20に連結されており、その上端部から縫合糸10を内部に引き込むために設けられる。上述の通り引込機構40の構造は上記押出機構30とほぼ同様であるため同一の符号を付してその説明は省略する。
また、図示は省略するが、引込機構40の糸保持部本体33aの半円形の開口部33hの内面は、縫合糸10が挿入方向（引込方向）へは移動容易であり且つ挿入方向と反対方向へは移動し難くなるようにコマ12の形状に対応した縮径構造を備えている。 The retraction mechanism 40 has a lower end connected to the base 20, and is provided to draw the suture 10 into the interior from the upper end. As described above, the structure of the retracting mechanism 40 is substantially the same as that of the pushing mechanism 30, and thus the same reference numerals are given and the description is omitted.
Although not shown, the inner surface of the semicircular opening 33h of the thread holding portion main body 33a of the retraction mechanism 40 is easy for the suture 10 to move in the insertion direction (retraction direction) and is opposite to the insertion direction. It has a reduced diameter structure corresponding to the shape of the top 12 so that it is difficult to move.

次に、引込機構40単体の動作について説明する。
糸保持部本体33aの半円形の開口部33hには、上記押出機構30から押し出された縫合糸10が、その上方から下方に向かって挿入されており、これにより糸保持部33は縫合糸10を保持している。この状態では縫合糸10は環状になっている。
この状態から第2ワイヤ33gを下方に引っ張ることで第2ロッド33eがパイプ33bの左側の内部を下方に移動していき、糸保持部本体33aは縫合糸10を保持した状態で、第2リンク部材32の2本の円柱に案内されながら長手方向に沿って下方に移動する。これにより一回の引込動作が完了する。
なお、第2ロッド33eに押された最も左側のボール33cから順に複数のボール33cがパイプ33b内の屈曲箇所を右方向に移動していき、最も右側に位置するボール33cによって第1ロッド33dは上方に押し上げられた状態になっている。
押出機構30による一回の押出動作と引込機構40による一回の引込動作は交互にタイミングを合わせて行うのが好ましく、これにより縫合糸10が押出機構30と引込機構40との間で過度に弛んで絡まったり、過度に引っ張られて切断されることを防止できる。 Next, the operation of the retracting mechanism 40 alone will be described.
The suture thread 10 extruded from the pushing mechanism 30 is inserted downward into the semicircular opening 33h of the thread holding part body 33a from above, whereby the suture holding part 33 Holding. In this state, the suture 10 has an annular shape.
By pulling the second wire 33g downward from this state, the second rod 33e moves downward inside the left side of the pipe 33b, and the thread holding portion main body 33a holds the suture 10 while the second link The member 32 moves downward along the longitudinal direction while being guided by the two columns of the member 32. This completes one pull-in operation.
In addition, a plurality of balls 33c move rightward in the bent portion in the pipe 33b in order from the leftmost ball 33c pressed by the second rod 33e, and the first rod 33d is moved by the ball 33c located on the rightmost side. It has been pushed up.
It is preferable that one push operation by the push mechanism 30 and one pull operation by the pull mechanism 40 are alternately performed at the same timing, so that the suture 10 is excessively moved between the push mechanism 30 and the pull mechanism 40. It can be prevented from becoming loose and entangled or being cut by being excessively pulled.

上述した通り、縫合糸10は押出機構30と引込機構40のそれぞれの糸保持部本体33aにおいて挿入方向に移動容易となるように保持されている。したがって、一回の押出動作が完了した後、押出機構30の第2ワイヤ33gを下方に引っ張ることで上方に押し上げられた状態の第2ロッド33e及び糸保持部本体33aは下方に引き下げられ、縫合糸10は半円形の開口部33h内を相対的に挿入方向（上方）に移動する。また、一回の引込動作が完了した後、引込機構40の第1ワイヤ33fを下方に引っ張ることで、下方に押し下げられていた第2ロッド33e及び糸保持部本体33aは上方に引き上げられ、縫合糸10は半円形の開口部33h内を相対的に挿入方向（下方）に移動していく。
このような押出動作及び引込動作を繰り返し行い、環状になった縫合糸10の径を次第に小さくしていくことで縫合作業を行なう。 As described above, the suture 10 is held in the respective thread holding portion main bodies 33a of the push-out mechanism 30 and the retraction mechanism 40 so as to be easily movable in the insertion direction. Therefore, after one push operation is completed, the second rod 33e and the thread holding portion main body 33a in a state of being pushed upward by pulling the second wire 33g of the push mechanism 30 downward are pulled down and stitched. The thread 10 relatively moves in the insertion direction (upward) in the semicircular opening 33h. Further, after one retraction operation is completed, by pulling down the first wire 33f of the retraction mechanism 40, the second rod 33e and the thread holding portion main body 33a, which have been pushed down, are pulled up and sewn. The thread 10 relatively moves in the insertion direction (downward) in the semicircular opening 33h.
Such a pushing operation and a retracting operation are repeated, and the diameter of the annular suture 10 is gradually reduced to perform the suturing operation.

次に、縫合装置1全体の動作について説明する。
図14は、基台20に対して押出機構30及び引込機構40を垂直方向に起立させると共に縫合糸10を保持させた状態を模式的に示している。
この状態から第1のT字状部材36を上方に移動させると、図15〜図17に示すように第1リンク部材31が第1関節部34を中心にして回転する。
第1リンク部材31が回転し終えた後、第2のT字状部材39を下方に移動させることで図18に示すように第2リンク部材32を第2関節部38を中心にして回転させていき、最終的に図19に示すように第2リンク部材32の上端同士が間隔を開けてほぼ対向する位置まで回転させる。実際の縫合作業時にはこの状態で第2リンク部材32の上端同士の間に胃壁等の縫合対象物100を位置させることになる。
なお、第1のT字状部材36と第2のT字状部材39とを同時に移動させてもよい。 Next, the operation of the entire suturing device 1 will be described.
FIG. 14 schematically shows a state in which the push-out mechanism 30 and the retraction mechanism 40 are erected in the vertical direction with respect to the base 20, and the suture 10 is held.
When the first T-shaped member 36 is moved upward from this state, the first link member 31 rotates about the first joint 34 as shown in FIGS.
After the first link member 31 has finished rotating, the second T-shaped member 39 is moved downward to rotate the second link member 32 about the second joint 38 as shown in FIG. Finally, as shown in FIG. 19, the second link member 32 is rotated to a position where the upper ends of the second link member 32 are substantially opposed to each other with an interval. During the actual suturing operation, the suturing target 100 such as the stomach wall is positioned between the upper ends of the second link members 32 in this state.
Note that the first T-shaped member 36 and the second T-shaped member 39 may be moved simultaneously.

次に、押出機構30の第1ワイヤ33fを下方に引っ張ることで、図20〜図22に示すように縫合糸10を押出機構30の第2リンク部材32の上端から外側に押し出す。
図23に示すように押し出された縫合糸10はまずその針11が自身の締結部14に挿入され、次に当該針11は引込機構40の糸保持部本体33aに保持されることで、縫合糸10が環状に形成される。
そして、上述の通り押出動作と引込動作とをタイミングを合わせながら繰り返し行うことで、図24及び図25に示すように環状になった縫合糸10の径を小さくしていき、適当なタイミングで押出動作と引込動作を終了する。
次に、第2のT字状部材39を上方に移動させることで、図26に示すように第2リンク部材32の上端同士を遠ざける方向に回転させる。
第2リンク部材32の回転に伴い、縫合糸10は各糸保持部本体33aの半円形の開口部33hの側面から抜け出し、これによって一本の縫合糸10による縫合対象物100への一箇所の縫合作業が完了する。
そして、作業者は縫合装置1を体内から一旦取り出し、新たな縫合糸10をセットした後、再び体内に挿入し、次の縫合箇所で縫合作業を行う。
なお、一連の縫合作業は作業者が縫合装置1とは別に体内に挿入している内視鏡で監視しながら行うことになる。 Next, by pulling the first wire 33f of the pushing mechanism 30 downward, the suture 10 is pushed outward from the upper end of the second link member 32 of the pushing mechanism 30 as shown in FIGS.
As shown in FIG. 23, the extruded suture 10 has its needle 11 inserted into its own fastening portion 14, and then the needle 11 is held by the thread holding portion main body 33 a of the retracting mechanism 40, so that the suture is The yarn 10 is formed in an annular shape.
Then, by repeating the pushing operation and the retracting operation at the same timing as described above, the diameter of the annular suture 10 is reduced as shown in FIGS. 24 and 25, and the pushing operation is performed at an appropriate timing. The operation and the pull-in operation are completed.
Next, by moving the second T-shaped member 39 upward, as shown in FIG. 26, the second link member 32 is rotated in a direction in which the upper ends of the second link members 32 are separated from each other.
With the rotation of the second link member 32, the suture 10 comes out of the side surface of the semicircular opening 33h of each thread holding portion main body 33a, and thereby, one suture 10 The suturing operation is completed.
Then, the operator once removes the suturing device 1 from the body, sets a new suture thread 10, inserts the suturing device 10 again into the body, and performs a suturing operation at the next sewn place.
In addition, a series of suturing operations are performed while an operator monitors with an endoscope inserted into the body separately from the suturing device 1.

次に、本発明の縫合装置に適した縫合糸の実施例1を説明する。
本実施例では縫合糸の条件である生体内で吸収される材料としてポリカプロラクトンを用いた。
図27は縫合糸の成形に使用した金型である。溶融させたポリカプロラクトンを金型に注入し、金型温度85度、90度、95度の3パターンで図28に示すとおり5分間加熱し、20 MPaで5分押圧後、冷水で急冷することで3種類の縫合糸を得た。図29に示すとおり一つのコマの長さを1.5 mm, 大径部の径を1.0 mm, 小径部の径を0.6 mmにした。 Next, Embodiment 1 of a suture suitable for the suturing device of the present invention will be described.
In this example, polycaprolactone was used as a material that is absorbed in a living body, which is a condition of a suture.
FIG. 27 shows a mold used for forming a suture. Inject the molten polycaprolactone into the mold, heat the mold at three patterns of 85 ° C, 90 ° C, and 95 ° C for 5 minutes as shown in Fig. 28, press at 20 MPa for 5 minutes, and quench with cold water. Gave three types of sutures. As shown in FIG. 29, the length of one piece was 1.5 mm, the diameter of the large diameter portion was 1.0 mm, and the diameter of the small diameter portion was 0.6 mm.

3種類の縫合糸の評価試験として、引張強度試験、正送り試験及び逆送り試験を行った。
引張強度試験として図30に示すとおり各縫合糸の段付き部の前後を把持し、前方に向かって引っ張った。
図31は引張強度試験の結果を示すグラフである。
正送り試験として図32に示すとおり各縫合糸を締結部に挿入した状態で段付き部の前方と締結部を把持し、前方に向かって引っ張った。
図33は正送り試験の結果を示すグラフである。
逆送り試験として図34に示すとおり各縫合糸を締結部に挿入した状態で段付き部の前方と締結部を把持し、後方に向かって引っ張った。
図35は正送り試験の結果を示すグラフである。
図36(a)は試験結果をまとめたものであり、図36(b)に示すJISの医療用絹製縫合糸の基準を満たしていることが分かった。 As an evaluation test of the three types of sutures, a tensile strength test, a forward feed test, and a reverse feed test were performed.
As shown in FIG. 30, as a tensile strength test, the front and rear of the stepped portion of each suture were grasped and pulled forward.
FIG. 31 is a graph showing the results of the tensile strength test.
As shown in FIG. 32, as shown in FIG. 32, the forward portion of the stepped portion and the fastening portion were grasped and pulled forward as a forward feed test with each suture inserted into the fastening portion.
FIG. 33 is a graph showing the results of the forward feed test.
As a reverse feed test, as shown in FIG. 34, in a state where each suture was inserted into the fastening portion, the front of the stepped portion and the fastening portion were gripped and pulled backward.
FIG. 35 is a graph showing the results of the forward feed test.
FIG. 36 (a) summarizes the test results, and it was found that the JIS medical silk suture standard shown in FIG. 36 (b) was satisfied.

次に、本発明の縫合装置に適した縫合糸の実施例2を説明する。
本実施例では図37に示すとおり縫合糸の条件である生体内で吸収される材料として針にポリ乳酸を用い、コマ（段付き部）にポリカプロラクトンを用いた。成形方法は実施例1と同様であるが、金型に対して最初にポリ乳酸を注入し、次にポリカプロラクトンを注入した点が異なる。
図38は3種類の縫合糸の引張強度試験の結果を示すグラフである。途中で部分的に破断しているが、針と段付き部との接合箇所では破断しなかった。
図39は手作業により縫合糸を豚の胃壁に貫通させ、環状に縫合した状態を示している。 Next, a second embodiment of the suture suitable for the suturing apparatus of the present invention will be described.
In this example, as shown in FIG. 37, polylactic acid was used for the needle and polycaprolactone was used for the coma (stepped portion) as a material to be absorbed in the living body, which is the condition of the suture. The molding method is the same as that of Example 1, except that polylactic acid is first injected into the mold, and then polycaprolactone is injected.
FIG. 38 is a graph showing the results of tensile strength tests on three types of sutures. Although it was partially broken on the way, it did not break at the joint between the needle and the stepped portion.
FIG. 39 shows a state in which a suture is manually penetrated into the stomach wall of a pig and is sutured in an annular shape.

本発明は内視鏡的処置術に用いる小型且つ操作性が高い縫合装置に関するものであり、産業上の利用可能性を有する。

The present invention relates to a compact and high operability suturing equipment used in endoscopic procedures surgery, has industrial applicability.

1 縫合装置
10 縫合糸
11 針
12 コマ
13 段付き部
14 締結部
20 基台
30 押出機構
31 第1リンク部材
31a 溝
32 第2リンク部材
33 糸保持部
33a 糸保持部本体
33b パイプ
33c 複数のボール
33d 第1ロッド
33e 第2ロッド
33f 第1ワイヤ
33g 第2ワイヤ
33h 半円形の開口部
33i 開口部
34 第1関節部
35 案内環
36 第1のT字状部材
37 凸部
38 第2関節部
39 第2のT字状部材
40 引込機構
100 縫合対象物
1 suturing device
10 suture
11 needles
12 frames
13 Stepped part
14 Fastening part
20 bases
30 Extrusion mechanism
31 1st link member
31a groove
32 Second link member
33 Thread holding section
33a Thread holding section main body
33b pipe
33c multiple balls
33d 1st rod
33e 2nd rod
33f 1st wire
33g 2nd wire
33h semi-circular opening
33i opening
34 1st joint
35 Guide ring
36 1st T-shaped member
37 convex
38 2nd joint
39 Second T-shaped member
40 Retraction mechanism
100 Objects to be sutured

Claims

An extruding mechanism having a lower end connected to the base and pushing out the suture from the upper end;
A lower end connected to the base, and a retracting mechanism for pulling in the suture from the upper end,
The push-out mechanism and the retraction mechanism each include at least a first link member, a second link member, and a yarn holding unit,
The first link member is rotatably supported on the base at a first joint at a lower end of the first link member, and the second link at a second joint at an upper end of the first link member . It is supported rotatably relative to the link member,
The suturing apparatus according to claim 1, wherein the thread holding portion is supported movably along a longitudinal direction of the second link member while holding the suture.

The thread holding section has a thread holding section main body having an opening through which the suture is inserted, a U-shaped pipe, a plurality of balls inserted into the pipe, and one end of the pipe. The first rod, which is in contact with the ball at the lower end of the first rod, and which is inserted into the other end of the pipe, makes contact with the ball at the lower end of the second rod, and holds the thread at the upper end of the second rod. The second rod, which is joined to the main body, a first wire that pulls the first rod downward, and a second wire that pulls the second rod downward,
By pulling the first wire downward, the first rod moves downward in the pipe, and the plurality of balls pushed by the first rod move in the pipe, so that the second rod moves. Move upward in the pipe, whereby the thread holding portion main body moves upward along the longitudinal direction of the second link member while holding the suture. A suturing device as described.

The suture includes a needle at a distal end of the suture, and a stepped portion formed by continuously extending a piece whose diameter increases from a distal end to a rear end in the middle of the suture. 3. The suturing device according to claim 1, further comprising a fastening portion that is fastened at the stepped portion by inserting the suture itself into a rear end of the suturing device.

The suturing device according to any one of claims 1 to 3, wherein the suture is made of a material that can be absorbed in a living body.

At the time of starting the suturing operation, the needle is located at the upper end of the second link member of the pushing mechanism, and the stepped portion is held by the thread holding section of the pushing mechanism and the thread holding section of the pull-in mechanism. The fastening portion is located at an upper end of a second link member of the retraction mechanism,
With the upper end of the second link member of the push-out mechanism and the upper end of the second link member of the pull-in mechanism facing each other, the pull-in mechanism sequentially pulls in the sutures sequentially extruded from the push-out mechanism to form a suture in an annular shape. 4. The suturing device according to claim 3, wherein the suturing device is fixed at the fastening portion.