JP7187530B2 - Medical two-way suturing device and its operating method - Google Patents

Medical two-way suturing device and its operating method Download PDF

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JP7187530B2
JP7187530B2 JP2020502065A JP2020502065A JP7187530B2 JP 7187530 B2 JP7187530 B2 JP 7187530B2 JP 2020502065 A JP2020502065 A JP 2020502065A JP 2020502065 A JP2020502065 A JP 2020502065A JP 7187530 B2 JP7187530 B2 JP 7187530B2
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祥平 鈴木
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    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
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Description

本発明は、近位側から遠位側および遠位側から近位側の双方向に糸による対象物の縫合が可能な医療用双方向縫合装置およびその作動方法に関する。 TECHNICAL FIELD The present invention relates to a medical two-way suturing device capable of suturing an object in both directions from the proximal side to the distal side and from the distal side to the proximal side, and a method of operating the same.

脳下垂体にできた腫瘍を摘出するために、しばしば経蝶形骨洞下垂体腫瘍摘出術(TSS;Trans-Sphenoidal Surgery)が行われる。TSSは、一般的に以下の手順で行われる。まず、術者は患者の鼻中隔に沿って鼻粘膜を剥離しながら進展し、蝶形骨を開窓し硬膜を開くことで下垂体に到達する。次いで下垂体腫瘍を摘出し、最後に硬膜を縫合して蝶形骨や鼻粘膜を再建する。硬膜を縫合するための装置では、硬膜の遠位側から近位側、および近位側から遠位側の2方向に縫合糸を通すことが提案されている(特許文献1~10)。 Trans-Sphenoidal Surgery (TSS) is often performed to remove tumors in the pituitary gland. TSS is generally performed by the following procedures. First, the operator advances along the patient's nasal septum while detaching the nasal mucosa, opens the sphenoid bone and opens the dura mater to reach the pituitary gland. Next, the pituitary tumor is removed, and finally the dura is sutured to reconstruct the sphenoid bone and nasal mucosa. In a device for suturing the dura mater, it has been proposed to pass the suture thread in two directions, from the distal side to the proximal side of the dura mater and from the proximal side to the distal side (Patent Documents 1 to 10). .

特表2012-515636号公報Japanese Patent Publication No. 2012-515636 国際公開第2010/085793号WO2010/085793 特表2014-528768号公報Japanese Patent Publication No. 2014-528768 国際公開第2013/024466号WO2013/024466 特表2011-509121号公報Japanese Patent Publication No. 2011-509121 国際公開第2009/089101号WO2009/089101 特開2011-72790号公報JP 2011-72790 A 特表2004-519299号公報Japanese Patent Publication No. 2004-519299 特開2014-236995号公報JP 2014-236995 A 国際公開第2017/163600号WO2017/163600

しかし、特許文献1、2に記載された糸通し装置において、針の切り欠きから遠位側ブームアームハウジングの溝内に縫合糸を移動させることは、物理的に難しいという課題がある。また、縫合針をブームアームハウジングに密着させながら移動させる必要があるため、移動の際に縫合糸がブームアームハウジングに擦れることで縫合糸が破断したり変形するリスクがある。 However, in the threading devices described in Patent Documents 1 and 2, there is a problem that it is physically difficult to move the suture thread from the notch of the needle into the groove of the distal boom arm housing. In addition, since the suture needle must be moved while being in close contact with the boom arm housing, there is a risk that the suture thread will rub against the boom arm housing during movement, resulting in breakage or deformation of the suture thread.

特許文献3、4および特許文献7に記載された装置では、縫合糸にノットを作製したり、フェルールに結びつけたりする必要があるため、これらの作業に時間を要する。 The devices described in US Pat.

特許文献5、6に記載された縫合糸保持器において針を双方向に往復させるためには、その都度、針を把持し直して把持位置を変更する必要があるが、針が脱落して生体組織を不用意に傷つけたり、脱落した針を探す手間が発生する可能性がある。 In order to reciprocate the needle in both directions in the suture holders described in Patent Documents 5 and 6, it is necessary to re-grip the needle and change the holding position each time. There is a possibility that the tissue may be damaged carelessly, and troublesome work may occur to search for the needle that has fallen off.

特許文献8に記載されたエンドスコープ型縫合機は、針によって形成される糸輪を往復させるためにルーパーを多次元運動軌道に沿って回転運動させている間、手で縫合対象物の送り運動を行う必要がある。また、2枚の生体組織を重ねて端辺をかがり縫いすることを目的としているため、TSSにおける硬膜縫合は行うことができない。 The endoscopic suturing machine described in US Pat. No. 5,300,001 manually feeds an object to be sutured while rotationally moving a looper along a multi-dimensional motion trajectory to reciprocate a thread loop formed by a needle. need to do In addition, since the purpose is to overlap two sheets of body tissue and overlock the edges, dura suturing in TSS cannot be performed.

特許文献9に記載された縫合デバイスは、縫合する際に縫合糸クラスプ・アームによって縫合対象物である組織部分を把持する必要があるため、当該組織部分を傷付ける可能性がある。2枚の生体組織がクラスプ・アームにて把持できる位置にないと縫合ができないため、縫合前に生体組織を適切な位置に配置する作業が必要となる。 The suturing device described in Patent Literature 9 needs to grasp the tissue portion, which is the object to be sutured, by the suture clasp arms when suturing, and thus there is a possibility of damaging the tissue portion. Since suturing cannot be performed unless the two sheets of living tissue are in a position where they can be grasped by the clasp arms, it is necessary to arrange the living tissue at appropriate positions before suturing.

特許文献10に記載された縫合装置では、針部材に糸の把持および解除機構を設けるために例えば針部材の内側に内筒部材が配置されるが、針部材の外径を小さくするには緻密な設計および製造が必要であるため、歩留まりが低くなり生産コストが上昇するおそれがある。 In the suturing device described in Patent Document 10, the inner cylinder member is arranged inside the needle member, for example, in order to provide the needle member with a thread gripping and releasing mechanism. It requires sophisticated design and manufacturing, which can lead to low yields and high production costs.

そこで、本発明は、簡便な操作で人体に対して低侵襲に縫合を行うことができ、かつ工業生産により適した医療用双方向縫合装置を提供することを目的とする。 SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide a medical two-way suturing apparatus that can perform suturing on the human body with simple operation and minimally invasiveness and that is more suitable for industrial production.

上記課題を解決し得た本発明の医療用双方向縫合装置は、遠近方向に延在している筐体と、筐体に設けられている第1針部材と第2針部材と、を有しており、第1針部材は、第2針部材よりも近位側に配置されており、第1針部材と第2針部材は、それぞれ遠近方向に延在しており、第1針部材は、先端が遠位側を向いており、第2針部材は、先端が近位側を向いている点に要旨を有する。本発明の医療用双方向縫合装置によれば、近位側から遠位側に糸を送るときには第1針部材を使用し、遠位側から近位側に糸を送るときには第2針部材を使用することで確実に双方向に縫合することができる。また、各針部材は、少なくとも糸を進行方向に送り出すことができればよいため、針部材の形状が過度に複雑化することによる生産コストの上昇を抑制できる。さらに、針部材の外径を小さくすることが可能となるため、人体に対して低侵襲に縫合を行うことができる。 The two-way medical suturing device of the present invention, which has solved the above problems, has a housing extending in the far-near direction, and a first needle member and a second needle member provided in the housing. , the first needle member is arranged more proximal than the second needle member, the first needle member and the second needle member each extend in the near-field direction, and the first needle member has a tip facing distally, and the second needle member has a tip facing proximally. According to the two-way suturing device for medical use of the present invention, the first needle member is used when feeding the thread from the proximal side to the distal side, and the second needle member is used when feeding the thread from the distal side to the proximal side. By using it, it is possible to reliably suture in both directions. Moreover, since each needle member needs only to be able to send out the yarn in the advancing direction, it is possible to suppress an increase in production cost due to excessively complicated shape of the needle member. Furthermore, since it is possible to reduce the outer diameter of the needle member, it is possible to suture the human body in a minimally invasive manner.

上記医療用双方向縫合装置において、第1針部材と第2針部材は、遠近方向に沿って移動可能であることが好ましい。 In the medical two-way suturing device, the first needle member and the second needle member are preferably movable in the distance direction.

上記医療用双方向縫合装置において、遠近方向から見て、第1針部材と第2針部材が互いに重なっていることが好ましい。 In the above two-way medical suturing device, it is preferable that the first needle member and the second needle member overlap each other when viewed from near and far.

上記医療用双方向縫合装置において、第1針部材または第2針部材の先端が、少なくとも第1端部と第2端部の二又に分かれていることが好ましい。 In the above two-way suturing device for medical use, it is preferable that the tip of the first needle member or the second needle member is bifurcated into at least a first end portion and a second end portion.

上記医療用双方向縫合装置において、筐体は、第1針部材と第2針部材との間における遠近方向と垂直な断面において、医療用双方向縫合装置の重心から第1針部材の中心軸に向かう上方向と、中心軸から重心に向かう下方向を有しており、第1端部と第2端部が上下方向に離間していることが好ましい。 In the above-described bidirectional medical suturing device, the housing extends from the center of gravity of the bidirectional medical suturing device to the central axis of the first needle member in a cross section perpendicular to the direction of distance between the first needle member and the second needle member. and a downward direction from the central axis to the center of gravity, and the first end and the second end are preferably spaced apart in the vertical direction.

上記医療用双方向縫合装置は、さらに、第1針部材よりも遠位側に配置されている第1糸保持機構と、第2針部材の先端と第1糸保持機構の遠位端の間に配置されている第2糸保持機構と、を有していることが好ましい。 The bidirectional medical suturing device further comprises a first thread holding mechanism disposed distally of the first needle member, and a thread holding mechanism between the tip of the second needle member and the distal end of the first thread holding mechanism. and a second thread holding mechanism located at the .

上記医療用双方向縫合装置は、第1針部材の遠位端よりも近位側に配置されている第1糸保持機構と、第2針部材の先端と第1糸保持機構の遠位端の間に配置されている第2糸保持機構と、第1糸保持機構に接続されており、第1保持機構の少なくとも一部を第1針部材の遠位端よりも遠位側に移動させる移動機構と、を含むことが好ましい。 The two-way suturing device for medical use includes a first thread holding mechanism arranged proximal to the distal end of the first needle member, and a tip of the second needle member and a distal end of the first thread holding mechanism. and a second thread retention mechanism positioned between the and a moving mechanism.

上記医療用双方向縫合装置において、筐体は、第1針部材と第2針部材との間における遠近方向と垂直な断面において、医療用双方向縫合装置の重心から第1針部材の中心軸に向かう上方向と、中心軸から重心に向かう下方向を有しており、第1糸保持機構または第2糸保持機構は、上下方向以外の第1方向を軸として回転することが好ましい。 In the above-described bidirectional medical suturing device, the housing extends from the center of gravity of the bidirectional medical suturing device to the central axis of the first needle member in a cross section perpendicular to the direction of distance between the first needle member and the second needle member. and a downward direction from the central axis to the center of gravity, and the first thread holding mechanism or the second thread holding mechanism preferably rotates about the first direction other than the vertical direction.

上記医療用双方向縫合装置において、第1方向が、遠近方向または、上下方向および遠近方向の両方に垂直な方向であることが好ましい。 In the above bidirectional medical suturing device, the first direction is preferably a perspective direction or a direction perpendicular to both the vertical direction and the perspective direction.

上記医療用双方向縫合装置は、近位側に操作部を有し、第1糸保持機構は、第1方向を軸とする回転軸と、回転軸を挟んだ一方側に設けられており、操作部に直接または間接的に固定されている固定部と、回転軸を挟んだ他方側に設けられており、糸が当接する糸当接部と、を有することが好ましい。 The medical two-way suturing device has an operation part on the proximal side, and the first thread holding mechanism is provided on one side of the rotating shaft centered in the first direction and on either side of the rotating shaft, It is preferable to have a fixed portion that is directly or indirectly fixed to the operation portion, and a thread abutting portion that is provided on the other side of the rotating shaft and abuts against the thread.

上記医療用双方向縫合装置において、第1糸保持機構または第2糸保持機構は、第1針部材または第2針部材の軸中心に向かって突出可能であることが好ましい。 In the above bidirectional medical suturing device, it is preferable that the first thread holding mechanism or the second thread holding mechanism can protrude toward the axial center of the first needle member or the second needle member.

上記医療用双方向縫合装置において、第1糸保持機構と第2糸保持機構の少なくともいずれか一方が、遠近方向に沿って移動可能であることが好ましい。 In the medical two-way suturing device, it is preferable that at least one of the first thread holding mechanism and the second thread holding mechanism is movable in the distance direction.

上記医療用双方向縫合装置には、さらに、第1針部材を内包する第1筒部材と、第2針部材を内包する第2筒部材が設けられており、第1筒部材と第2筒部材の少なくともいずれか一方が、遠近方向に沿って移動可能であることが好ましい。 The bidirectional suturing device for medical use is further provided with a first tubular member enclosing the first needle member and a second tubular member enclosing the second needle member. At least one of the members is preferably movable along the perspective direction.

上記医療用双方向縫合装置において、第1糸保持機構が第1筒部材に設けられている構成と、第2糸保持機構が第2筒部材に設けられている構成の少なくともいずれか一方の構成を有していることが好ましい。 In the above bidirectional medical suturing device, at least one of a configuration in which the first thread holding mechanism is provided on the first tubular member and a configuration in which the second thread holding mechanism is provided on the second tubular member. It is preferable to have

上記医療用双方向縫合装置において、第1筒部材の遠位端面と第2筒部材の近位端面が向かい合っていることが好ましい。 In the above two-way medical suturing device, it is preferable that the distal end surface of the first tubular member and the proximal end surface of the second tubular member face each other.

上記課題を解決し得た本発明の医療用双方向縫合装置の作動方法の一実施態様は、遠近方向に延在している筐体と、筐体に設けられている第1針部材と第2針部材と、を有しており、第1針部材は、第2針部材よりも近位側に配置されており、第1針部材と第2針部材は、それぞれ遠近方向に延在しており、第1針部材は、先端が遠位側を向いており、第2針部材は、先端が近位側を向いている医療用双方向縫合装置を準備するステップと、第1針部材と第2針部材との間に縫合対象物を配置するステップと、第1針部材を遠位側に移動させ、糸の一部を縫合対象物よりも遠位側に配置するステップと、第1針部材を近位側に移動させるステップと、第1針部材が遠位側へ移動した際の位置と異なる位置に、第2針部材が配置されるように装置を移動させるステップと、第2針部材を近位側に移動させ、糸の一部を縫合対象物よりも近位側に配置するステップと、第2針部材を遠位側に移動させるステップと、を含む点に要旨を有する。本発明の医療用双方向縫合装置の作動方法によれば、近位側から遠位側に糸を送るときには第1針部材を使用し、遠位側から近位側に糸を送るときには第2針部材を使用することで確実に双方向に縫合することができる。また、各針部材は、少なくとも糸を進行方向に送り出すことができればよいため、針部材の形状が過度に複雑化することによる生産コストの上昇を抑制できる。さらに、針部材の外径を小さくすることが可能となるため、人体に対して低侵襲に縫合を行うことができる。 One embodiment of the operating method of the two-way medical suturing device of the present invention, which has solved the above problems, comprises a housing extending in the far-near direction; and two needle members, the first needle member being disposed proximal to the second needle member, the first needle member and the second needle member each extending in the distal and proximal directions. providing a two-way medical suturing device in which the first needle member has a distally pointing tip and the second needle member has a proximally pointing tip; and a second needle member; moving the first needle member distally to place a portion of the thread distal to the suturing object; moving one needle member proximally; moving the device such that the second needle member is at a different position than the first needle member was at when the first needle member was moved distally; The gist of the method is that it includes the steps of: moving two needle members proximally to dispose a portion of the thread proximal to the object to be sutured; and moving the second needle member distally. have. According to the operating method of the medical two-way suturing device of the present invention, the first needle member is used when feeding the thread from the proximal side to the distal side, and the second needle member is used when feeding the thread from the distal side to the proximal side. By using a needle member, it is possible to reliably perform suturing in both directions. Moreover, since each needle member needs only to be able to send out the yarn in the advancing direction, it is possible to suppress an increase in production cost due to excessively complicated shape of the needle member. Furthermore, since it is possible to reduce the outer diameter of the needle member, it is possible to suture the human body in a minimally invasive manner.

上記作動方法は、医療用双方向縫合装置を準備するステップにおいて、医療用双方向縫合装置は、さらに第1針部材よりも遠位側に配置されている第1糸保持機構と、第2針部材の先端と第1糸保持機構の遠位端の間に配置されている第2糸保持機構とを含み、医療用双方向縫合装置を準備するステップの後、第1糸保持機構により糸を保持するステップを行い、第1針部材と第2針部材との間に縫合対象物を配置するステップの後、前記縫合装置の遠近方向から見て、第1糸保持機構が第1針部材よりも半径方向の外側に位置するように第1糸保持機構を動かすステップを行い、第1針部材を近位側に移動させるステップの後、第2糸保持機構で糸を保持するステップを行い、第1針部材が遠位側へ移動した際の位置と異なる位置に、第2針部材が配置されるように前記縫合装置を移動させるステップの後、前記縫合装置の遠近方向から見て、第2糸保持機構が第2針部材よりも半径方向の外側に位置するように第2糸保持機構を動かすステップを行うことが好ましい。 In the above operating method, in the step of preparing the two-way medical suturing device, the two-way medical suturing device further comprises a first thread holding mechanism disposed distally of the first needle member and a second needle. a second thread retaining mechanism disposed between the distal end of the member and the distal end of the first thread retaining mechanism, wherein the thread is retained by the first thread retaining mechanism after the steps of providing the bi-directional medical suturing device; After performing the step of holding and placing the object to be sutured between the first needle member and the second needle member, the first thread holding mechanism extends from the first needle member when viewed from the perspective direction of the suturing device. moving the first thread holding mechanism so that the second thread holding mechanism is radially outwardly positioned; after moving the first needle member proximally, holding the thread with the second thread holding mechanism; After the step of moving the suturing device so that the second needle member is positioned at a position different from the position when the first needle member was moved distally, the suturing device is viewed from the near and far directions, Preferably, the step of moving the second thread holding mechanism so that the second thread holding mechanism is positioned radially outwardly of the second needle member is performed.

上記作動方法は、第1針部材または第2針部材のいずれか一方を移動させて、糸の一部を縫合対象物よりも近位側または遠位側に移動させるステップの前に、第1針部材または第2針部材のいずれか他方を、縫合対象物よりも遠位側または近位側に移動させるステップと、第1針部材または第2針部材のいずれか他方を縫合対象物よりも近位側または遠位側に移動させるステップとを含むことが好ましい。 Before the step of moving either the first needle member or the second needle member to move the portion of the thread proximally or distally of the object to be sutured, the first moving the other of the needle member or the second needle member to a distal side or a proximal side relative to the object to be sutured; moving proximally or distally.

本発明の医療用双方向縫合装置およびその作動方法によれば、近位側から遠位側に糸を送るときには第1針部材を使用し、遠位側から近位側に糸を送るときには第2針部材を使用することで確実に双方向に縫合することができる。また、各針部材は、少なくとも糸を進行方向に送り出すことができればよいため、針部材の形状が過度に複雑化することによる生産コストの上昇を抑制できる。さらに、針部材の外径を小さくすることが可能となるため、人体に対して低侵襲に縫合を行うことができる。 According to the two-way suturing device for medical use and the operating method thereof of the present invention, the first needle member is used when feeding the thread from the proximal side to the distal side, and the second needle member is used when feeding the thread from the distal side to the proximal side. Bi-directional suturing can be ensured by using two-needle members. Moreover, since each needle member needs only to be able to send out the yarn in the advancing direction, it is possible to suppress an increase in production cost due to excessively complicated shape of the needle member. Furthermore, since it is possible to reduce the outer diameter of the needle member, it is possible to suture the human body in a minimally invasive manner.

本発明の医療用双方向縫合装置の側面図(一部断面図)を表す。FIG. 2 shows a side view (partially cross-sectional view) of the two-way medical suturing device of the present invention. 本発明の医療用双方向縫合装置の遠位側の内部の斜視図を表す。FIG. 3 depicts a perspective view of the interior of the distal side of the bi-directional medical suturing device of the present invention. 本発明の医療用双方向縫合装置の遠位側の断面図(一部側面図)を表す。FIG. 2 shows a cross-sectional view (partial side view) of the distal side of the bi-directional medical suturing device of the present invention. 図1~図3に示した第1針部材の遠位側を拡大した側面図を表す。FIG. 4 depicts a side view with an enlarged distal side of the first needle member shown in FIGS. 1 to 3; FIG. 図4に示した第1針部材の側面図の変形例を表す。Fig. 5 shows a modification of the side view of the first needle member shown in Fig. 4; 図4に示した第1針部材の側面図の他の変形例を表す。Fig. 5 shows another modification of the side view of the first needle member shown in Fig. 4; 回転する糸保持機構を有する医療用双方向縫合装置の説明図を表す。FIG. 2 shows an illustration of a bi-directional medical suturing device with a rotating thread holding mechanism; 回転する糸保持機構を有する医療用双方向縫合装置の説明図を表す。FIG. 2 shows an illustration of a bi-directional medical suturing device with a rotating thread holding mechanism; 針部材の軸中心に突出可能な糸保持機構を有する医療用双方向縫合装置の説明図を表す。FIG. 4 shows an explanatory view of a medical two-way suturing device having a suture holding mechanism that can protrude from the axis of a needle member; 図9に示した医療用双方向縫合装置の説明図の変形例を表す。FIG. 10 shows a modification of the explanatory diagram of the bidirectional medical suturing device shown in FIG. 9 ; FIG. 糸を挟む糸保持機構の説明図を表す。FIG. 10 is an explanatory diagram of a thread holding mechanism that pinches a thread; 図11に示した糸保持機構を有する医療用双方向縫合装置の説明図を表す。FIG. 12 shows an explanatory view of the medical two-way suturing device having the thread holding mechanism shown in FIG. 11; 本発明の医療用双方向縫合装置の作動方法のステップS2、S3の説明図を表す。FIG. 4 is an explanatory diagram of steps S2 and S3 of the operating method of the medical two-way suturing device of the present invention; 本発明の医療用双方向縫合装置の作動方法のステップS4の説明図を表す。FIG. 10 is an explanatory diagram of step S4 of the operating method of the medical two-way suturing device of the present invention; 本発明の医療用双方向縫合装置の作動方法のステップS5の説明図を表す。FIG. 10 is an explanatory diagram of step S5 of the operating method of the medical two-way suturing device of the present invention; 本発明の医療用双方向縫合装置の作動方法のステップS6の説明図を表す。FIG. 10 is an explanatory diagram of step S6 of the operating method of the medical two-way suturing device of the present invention; 本発明の医療用双方向縫合装置の作動方法のステップS7の説明図を表す。FIG. 10 is an explanatory diagram of step S7 of the operating method of the two-way medical suturing device of the present invention; 本発明の医療用双方向縫合装置の作動方法のステップS8の説明図を表す。FIG. 10 is an explanatory diagram of step S8 of the operating method of the medical two-way suturing device of the present invention; 本発明の医療用双方向縫合装置の作動方法のステップS9の説明図を表す。FIG. 10 is an explanatory diagram of step S9 of the operating method of the bidirectional medical suturing device of the present invention; 本発明の医療用双方向縫合装置の作動方法のステップS10の説明図を表す。FIG. 10 is an explanatory diagram of step S10 of the operating method of the two-way medical suturing device of the present invention; 本発明の医療用双方向縫合装置の作動方法のステップS10の後に装置を回転させたときの説明図を表す。FIG. 10 is an explanatory diagram when the device is rotated after step S10 of the operation method of the medical two-way suturing device of the present invention; 本発明の医療用双方向縫合装置の作動方法のステップS11の説明図を表す。FIG. 4 is an explanatory diagram of step S11 of the operating method of the medical two-way suturing device of the present invention; 本発明の医療用双方向縫合装置の作動方法のステップS12の説明図を表す。FIG. 10 is an explanatory diagram of step S12 of the operating method of the medical two-way suturing device of the present invention; 本発明の医療用双方向縫合装置の作動方法のステップS13の説明図を表す。FIG. 10 is an explanatory diagram of step S13 of the operating method of the medical two-way suturing device of the present invention; 本発明の医療用双方向縫合装置の作動方法のステップS14の説明図を表す。FIG. 10 is an explanatory diagram of step S14 of the operating method of the medical two-way suturing device of the present invention; 本発明の医療用双方向縫合装置の作動方法のステップS15の説明図を表す。FIG. 10 is an explanatory diagram of step S15 of the operating method of the two-way medical suturing device of the present invention; 本発明の医療用双方向縫合装置の作動方法のステップS16の説明図を表す。FIG. 10 is an explanatory diagram of step S16 of the operating method of the medical two-way suturing device of the present invention; 本発明の医療用双方向縫合装置の作動方法のステップS17の説明図を表す。FIG. 10 is an explanatory diagram of step S17 of the operating method of the medical two-way suturing device of the present invention; 本発明の医療用双方向縫合装置の作動方法を適用した縫合対象物の説明図を表す。FIG. 4 is an explanatory diagram of an object to be sutured to which the operating method of the two-way medical suturing device of the present invention is applied; 本発明の医療用双方向縫合装置の他の作動方法のステップS104の説明図を表す。FIG. 10 is an explanatory diagram of step S104 of another operating method of the two-way medical suturing device of the present invention; 本発明の医療用双方向縫合装置の他の作動方法のステップS105の説明図を表す。FIG. 10 is an explanatory diagram of step S105 of another operating method of the two-way medical suturing device of the present invention; 本発明の医療用双方向縫合装置の他の作動方法のステップS106の説明図を表す。FIG. 10 is an explanatory diagram of step S106 of another operating method of the two-way suturing device for medical use of the present invention; 本発明の医療用双方向縫合装置の他の作動方法のステップS107の説明図を表す。FIG. 10 is an explanatory diagram of step S107 of another operating method of the two-way suturing device for medical use of the present invention; 本発明の医療用双方向縫合装置の他の作動方法のステップS108の説明図を表す。FIG. 10 is an explanatory diagram of step S108 of another operating method of the two-way medical suturing device of the present invention; 本発明の医療用双方向縫合装置の他の作動方法のステップS109の説明図を表す。FIG. 10 is an explanatory diagram of step S109 of another method of operating the bidirectional suturing device for medical use of the present invention; 本発明の医療用双方向縫合装置の他の作動方法のステップS111の説明図を表す。FIG. 10 is an explanatory diagram of step S111 of another operating method of the two-way suturing device for medical use of the present invention; 本発明の医療用双方向縫合装置の他の作動方法のステップS112の説明図を表す。FIG. 10 is an explanatory diagram of step S112 of another method of operating the bidirectional suturing device for medical use of the present invention; 本発明の医療用双方向縫合装置の他の作動方法のステップS113の説明図を表す。FIG. 10 is an explanatory diagram of step S113 of another operating method of the two-way suturing device for medical use of the present invention; 本発明の医療用双方向縫合装置の他の作動方法のステップS114の説明図を表す。FIG. 10 is an explanatory diagram of step S114 of another method of operating the bidirectional suturing device for medical use of the present invention; 本発明の医療用双方向縫合装置の他の作動方法のステップS115の説明図を表す。FIG. 10 is an explanatory diagram of step S115 of another method of operating the bidirectional suturing device for medical use of the present invention; 本発明の医療用双方向縫合装置の他の作動方法のステップS116の説明図を表す。FIG. 10 is an explanatory diagram of step S116 of another method of operating the bidirectional suturing device for medical use of the present invention; FIG.

以下、下記実施の形態に基づき本発明をより具体的に説明するが、本発明はもとより下記実施の形態によって制限を受けるものではなく、前・後記の趣旨に適合し得る範囲で適当に変更を加えて実施することも勿論可能であり、それらはいずれも本発明の技術的範囲に包含される。なお、各図面において、便宜上、ハッチングや部材符号等を省略する場合もあるが、かかる場合、明細書や他の図面を参照するものとする。また、図面における種々部材の寸法は、本発明の特徴の理解に資することを優先しているため、実際の寸法とは異なる場合がある。 Hereinafter, the present invention will be described in more detail based on the following embodiments, but the present invention is not limited by the following embodiments, and can be modified appropriately within the scope of the above and later descriptions. It is of course possible to carry out in addition, and all of them are included in the technical scope of the present invention. In each drawing, for the sake of convenience, hatching, member numbers, etc. may be omitted. In such cases, the specification and other drawings shall be referred to. In addition, the dimensions of various members in the drawings may differ from the actual dimensions, since priority is given to helping to understand the features of the present invention.

1.医療用双方向縫合装置
本発明の医療用双方向縫合装置は、遠近方向に延在している筐体と、筐体に設けられている第1針部材と第2針部材と、を有しており、第1針部材は、第2針部材よりも近位側に配置されており、第1針部材と第2針部材は、それぞれ遠近方向に延在しており、第1針部材は、先端が遠位側を向いており、第2針部材は、先端が近位側を向いている。本発明の医療用双方向縫合装置によれば、近位側から遠位側に糸を送るときには第1針部材を使用し、遠位側から近位側に糸を送るときには第2針部材を使用することで確実に双方向に縫合することができる。また、各針部材は、少なくとも糸を進行方向に送り出すことができればよいため、針部材の形状が過度に複雑化することによる生産コストの上昇を抑制できる。さらに、針部材の外径を小さくすることが可能となるため、人体に対して低侵襲に縫合を行うことができる。
1. Medical two-way suturing device A two-way medical suturing device of the present invention has a housing extending in the near and far direction, and a first needle member and a second needle member provided on the housing. The first needle member is arranged proximally relative to the second needle member, the first needle member and the second needle member each extend in the near-field direction, and the first needle member , the tip points distally and the second needle member points proximally. According to the two-way suturing device for medical use of the present invention, the first needle member is used when feeding the thread from the proximal side to the distal side, and the second needle member is used when feeding the thread from the distal side to the proximal side. By using it, it is possible to reliably suture in both directions. Moreover, since each needle member needs only to be able to send out the yarn in the advancing direction, it is possible to suppress an increase in production cost due to excessively complicated shape of the needle member. Furthermore, since it is possible to reduce the outer diameter of the needle member, it is possible to suture the human body in a minimally invasive manner.

医療用双方向縫合装置は、例えば、目視下、顕微鏡下、内視鏡画像下で、生体組織等の縫合対象物に、一方側から他方側および他方側から一方側の双方向に向かって糸を通すことができる処置具である。本明細書では単に「装置」または「縫合装置」と称することがある。 A two-way suturing device for medical use, for example, applies a thread to an object to be sutured, such as a living tissue, from one side to the other side and from the other side to the other side under visual observation, a microscope, or an endoscopic image. It is a treatment tool that can pass through. It may be referred to herein simply as a "device" or "suture device."

糸は、医療用として使用される縫合糸であり、単糸、編糸であってもよく、外径は一般的に縫合糸で使用される径であれば適宜選択可能である。また、糸の材料は、分解性材料であってもよい。糸の長さは、手術の邪魔にならない程度に十分に長いことが望ましく、20cm以上200cm以下が好ましい。例えば、TSSでは、縫合糸が体外から硬膜まで往復できる長さに、医師が患者の体外で縫合糸にノットを作製するのに十分な長さを加えた長さが好まれ、TSSで好ましい糸の長さは、具体的には、40cm以上150cm以下である。 The thread is a suture used for medical purposes, and may be a single thread or a knitted thread, and the outer diameter can be appropriately selected as long as it is a diameter commonly used for sutures. Also, the thread material may be a degradable material. The length of the thread is desirably long enough not to interfere with surgery, preferably 20 cm or more and 200 cm or less. For example, in TSS, a length that allows the suture to travel back and forth from outside the body to the dura plus a length sufficient for a physician to knot the suture outside the patient's body is preferred, and preferred in TSS. Specifically, the length of the thread is 40 cm or more and 150 cm or less.

まず、図1~図3を参照して、装置の全体構成について説明する。図1は本発明の縫合装置の側面図(一部断面図)であり、図2~図3は遠位側の内部の斜視図および断面図(一部側面図)である。なお、図2では、筐体の内部構造を把握しやすくするために筐体の外形を破線で示している。以降の斜視図も同様である。本発明に係る装置1は、筐体10と、第1針部材21と、第2針部材22を有している。以下では、第1針部材21と第2針部材22をまとめて「針部材20」と称することがある。各図において、矢印xが筐体10の遠近方向、矢印yが後述する上下方向を表している。 First, the overall configuration of the apparatus will be described with reference to FIGS. 1 to 3. FIG. FIG. 1 is a side view (partial cross-sectional view) of the suturing device of the present invention, and FIGS. 2 and 3 are a perspective view and a cross-sectional view (partial side view) of the interior of the distal side. In addition, in FIG. 2, the outer shape of the housing is indicated by a dashed line in order to facilitate understanding of the internal structure of the housing. The same applies to subsequent perspective views. The device 1 according to the invention comprises a housing 10 , a first needle member 21 and a second needle member 22 . Hereinafter, the first needle member 21 and the second needle member 22 may be collectively referred to as "the needle member 20". In each figure, an arrow x indicates a far-near direction of the housing 10, and an arrow y indicates a vertical direction, which will be described later.

筐体10は、針部材20と後述する糸保持機構30と筒部材40以外の部材が生体組織と接触することを抑制する。筐体10は、遠近方向xに延在している。本発明において、筐体10の近位側とは使用者の手元側の方向を指し、遠位側とは近位側の反対方向(すなわち処置対象側の方向)を指す。 The housing 10 prevents members other than the needle member 20, the thread holding mechanism 30 described later, and the tubular member 40 from coming into contact with living tissue. The housing 10 extends in the perspective direction x. In the present invention, the proximal side of the housing 10 refers to the direction toward the hand side of the user, and the distal side refers to the direction opposite to the proximal side (that is, the direction toward the treatment target).

図1に示すように、筐体10は近位側に使用者が手で把持するハンドル50を有していることが好ましい。詳細は後述するが、ハンドル50には第1針部材21と第2針部材22を動かす操作部が設けられることがより好ましい。筐体10の遠位端からハンドル50までの長さ(すなわち、筐体10の遠近方向xに延在している部分の長さ)は、術者の手元側から縫合位置までの距離を目安に設定すればよく、例えば5cm以上80cm以下にすることができる。TSSにおいては、下垂体から鼻穴までの距離を参考にして設定すればよく、例えば20cm以上50cm以下が好ましい。術者が操作しやすくするために、ハンドル50のグリップ部は筐体10の遠近方向xに対して垂直な方向(より好ましくは後述する下方向y2)に延在していることが好ましい。 As shown in FIG. 1, the housing 10 preferably has a handle 50 on the proximal side that is manually grasped by the user. Although the details will be described later, it is more preferable that the handle 50 is provided with an operating portion for moving the first needle member 21 and the second needle member 22 . The length from the distal end of the housing 10 to the handle 50 (that is, the length of the portion of the housing 10 extending in the far-near direction x) is the distance from the operator's hand side to the suturing position as a guideline. , for example, 5 cm or more and 80 cm or less. The TSS may be set with reference to the distance from the pituitary gland to the nostrils, and is preferably 20 cm or more and 50 cm or less, for example. For ease of operation by the operator, the grip portion of the handle 50 preferably extends in a direction perpendicular to the far-near direction x of the housing 10 (more preferably downward direction y2, which will be described later).

第1針部材21と第2針部材22は、縫合対象物70である硬膜等の生体組織に糸60を通すために用いられる部材である。糸60を掛けた針部材20を縫合対象物70に刺すことによって、縫合対象物70を挟んで近位側から遠位側、または遠位側から近位側に糸60の一部を移動させることができる。 The first needle member 21 and the second needle member 22 are members used to pass the thread 60 through a biological tissue such as the dura mater, which is the object 70 to be sutured. A part of the thread 60 is moved from the proximal side to the distal side or from the distal side to the proximal side across the sutured object 70 by piercing the sutured object 70 with the needle member 20 on which the thread 60 is hung. be able to.

第1針部材21と第2針部材22は、筐体10に設けられている。針部材20は、筐体10の表面上に設けられていてもよいが、図1~図3に示すように筐体10が中空部を有しており、針部材20が筐体10の中空部に設けられていることが好ましい。具体的には、筐体10のうち遠近方向xに延在している部分に、第1針部材21および第2針部材22が配置されていることが好ましい。これにより、非縫合時に筐体10から針部材20が露出しにくくなるため、縫合対象物70以外の部分に針部材20が接触しにくくなる。筐体10の遠近方向xに延在している部分は、円筒状、楕円筒状または多角筒状に形成することができる。 The first needle member 21 and the second needle member 22 are provided on the housing 10 . The needle member 20 may be provided on the surface of the housing 10, but the housing 10 has a hollow portion as shown in FIGS. It is preferably provided in the part. Specifically, it is preferable that the first needle member 21 and the second needle member 22 are arranged in a portion of the housing 10 that extends in the distance direction x. As a result, the needle member 20 is less likely to be exposed from the housing 10 when suturing is not performed, and thus the needle member 20 is less likely to come into contact with portions other than the suture object 70 . A portion of the housing 10 extending in the perspective direction x can be formed in a cylindrical shape, an elliptical cylindrical shape, or a polygonal cylindrical shape.

図3に示すように、筐体10は、第1針部材21と第2針部材22の間における遠近方向xと垂直な断面で、装置の重心から第1針部材21の中心軸に向かう上方向y1と、上記中心軸から上記重心に向かう下方向y2を有していてもよい。その場合、後述するように、針部材20の第1端部と第2端部が上下方向yに離間していることが好ましい。第1端部、第2端部とは、針部材の先端の少なくとも第1端部と第2端部の二又に分かれているそれぞれの端部である。例えば図4において、第1針部材21は先端21Aが第1端部21Bと第2端部21Cの二又に分かれている。これにより、針部材20に掛けられている部分以外で糸60は遠近方向xに沿って延在しやすくなり、糸60が邪魔にならずに装置1の各部材をスムーズに作動することができる。 As shown in FIG. 3, the housing 10 has a cross-section perpendicular to the perspective direction x between the first needle member 21 and the second needle member 22, and the center axis of the first needle member 21 from the center of gravity of the apparatus. It may have a direction y1 and a downward direction y2 from the central axis toward the center of gravity. In that case, as will be described later, it is preferable that the first end and the second end of the needle member 20 are spaced apart in the vertical direction y. The first end and the second end are the ends of the distal end of the needle member that are divided into at least the first end and the second end, respectively. For example, in FIG. 4, the tip 21A of the first needle member 21 is bifurcated into a first end 21B and a second end 21C. As a result, the thread 60 can easily extend along the perspective direction x in areas other than the portion where the needle member 20 is hooked, and each member of the device 1 can be smoothly operated without the thread 60 becoming an obstacle. .

筐体10には、縫合対象物70を配置するための凹部11が設けられていることが好ましい。凹部11は、筐体10の周方向の一部を切り欠くように形成されていることが好ましい。第1針部材21と第2針部材22の初期位置、すなわち図1~図3に示すように第1針部材21と第2針部材22を動かさない状態での位置で、凹部11が第1針部材21と第2針部材22の間に設けられていることが好ましい。これにより、第1針部材21と第2針部材22の間に縫合対象物70を配置し、第1針部材21と第2針部材22を遠近方向に沿って平行移動させることで縫合対象物70に針部材20を穿刺しやすくなる。縫合位置を確認しやすくするために、凹部11は、ハンドル50のグリップ部と反対側に当たる上下方向yの上側に配置されていることが好ましい。 It is preferable that the housing 10 is provided with a recess 11 for arranging the object 70 to be sutured. It is preferable that the recessed portion 11 is formed by cutting out a part of the housing 10 in the circumferential direction. In the initial position of the first needle member 21 and the second needle member 22, that is, the position in which the first needle member 21 and the second needle member 22 are not moved as shown in FIGS. It is preferably provided between needle member 21 and second needle member 22 . Thus, the object to be sewn 70 is placed between the first needle member 21 and the second needle member 22, and the object to be sewn is moved by moving the first needle member 21 and the second needle member 22 in parallel along the distance direction. It becomes easier to puncture the needle member 20 into 70 . In order to make it easier to confirm the stitching position, it is preferable that the concave portion 11 is arranged on the upper side in the vertical direction y, which is the side opposite to the grip portion of the handle 50 .

図示していないが、筐体10には凹部11を被装する保護蓋が取り付けられてもよい。これにより、縫合の前後に筐体10を体内で移動させるときに凹部11から針部材20の先端が露出することを防げる。保護蓋は、遠近方向xに移動可能に取り付けられていることが好ましい。また、保護蓋の開閉は、手元側の操作部で操作できることが好ましい。これにより、縫合時には保護蓋を移動させて凹部11を露出させ、非縫合時には保護蓋によって凹部11を覆うことができる。 Although not shown, the housing 10 may be provided with a protective lid that covers the recess 11 . This prevents the tip of the needle member 20 from being exposed from the concave portion 11 when the housing 10 is moved inside the body before and after suturing. It is preferable that the protective lid is attached so as to be movable in the perspective direction x. In addition, it is preferable that opening and closing of the protective lid can be operated by an operation section on the hand side. As a result, the protective lid can be moved to expose the concave portion 11 during suturing, and the concave portion 11 can be covered with the protective lid during non-suturing.

筐体10のうち体内に挿入される部分の外径は、例えば1.5mm以上、2mm以上、または3mm以上にすることができ、あるいは20mm以下、10mm以下、または8mm以下にすることができる。 The outer diameter of the portion of the housing 10 that is inserted into the body can be, for example, 1.5 mm or more, 2 mm or more, or 3 mm or more, or can be 20 mm or less, 10 mm or less, or 8 mm or less.

図1~図3に示すように、第1針部材21は、第2針部材22よりも近位側に配置されており、第1針部材21と第2針部材22は、それぞれ遠近方向xに延在しており、第1針部材21は先端21Aが遠位側を向いており、第2針部材22は先端22Aが近位側を向いている。近位側から遠位側への縫合では第1針部材21を使用し、遠位側から近位側への縫合では第2針部材22を使用する。第1針部材21によって近位側から縫合対象物70を通過して遠位側に送られた糸60は第2針部材22に渡されて、第2針部材22によって遠位側から縫合対象物70を通過して近位側に送られた糸60は第1針部材21に渡される。これにより、糸60を遠近方向xに移動させることが可能となり、縫合対象物70を縫合することができる。なお、針部材20は、少なくとも一部が遠近方向xに延在していればよく、針部材20の全体が遠近方向xに延在していてもよい。また、第1針部材21の先端21A(遠位端)よりも遠位側に第2針部材22の先端22A(近位端)が配置されることが好ましい。 As shown in FIGS. 1 to 3, the first needle member 21 is arranged proximally relative to the second needle member 22, and the first needle member 21 and the second needle member 22 each extend in the distance direction x. The first needle member 21 has a tip 21A facing distally and the second needle member 22 has a tip 22A facing proximally. The first needle member 21 is used for suturing from the proximal side to the distal side, and the second needle member 22 is used for suturing from the distal side to the proximal side. The thread 60 passed from the proximal side through the object to be sutured 70 by the first needle member 21 and sent to the distal side is passed to the second needle member 22 and passed through the object to be sutured from the distal side by the second needle member 22 . Thread 60 passed proximally through object 70 is passed over first needle member 21 . As a result, the thread 60 can be moved in the distance direction x, and the suturing object 70 can be sutured. At least a portion of the needle member 20 needs to extend in the perspective direction x, and the needle member 20 as a whole may extend in the perspective direction x. In addition, it is preferable that the tip 22A (proximal end) of the second needle member 22 be arranged on the distal side of the tip 21A (distal end) of the first needle member 21 .

第1針部材21と第2針部材22は、遠近方向xに沿って移動可能であることが好ましく、遠近方向xに沿って平行移動が可能であることがより好ましい。具体的には、第2針部材22を最も遠位側まで移動させたときに、第1針部材21は、第2針部材22の先端よりも近位側の位置まで移動可能であり、第1針部材21を最も近位側まで移動させたときに、第2針部材22は、第1針部材21の先端よりも遠位側の位置まで移動可能であることが好ましい。第1針部材21は、第2針部材22の先端よりも近位側であって筐体10の凹部11の遠位端よりも遠位側の位置まで移動可能であり、第2針部材22は、第1針部材21の先端よりも遠位側であって筐体10の凹部11の近位端よりも近位側の位置まで移動可能である構成とすることができる。これにより、第1針部材21により近位側から遠位側に糸60を送ることができ、第2針部材22により遠位側から近位側に糸60を送ることができる。 The first needle member 21 and the second needle member 22 are preferably movable along the perspective direction x, and more preferably parallelly movable along the perspective direction x. Specifically, when the second needle member 22 is moved to the most distal side, the first needle member 21 can move to a position closer to the proximal side than the tip of the second needle member 22. It is preferable that the second needle member 22 can move to a position distal to the tip of the first needle member 21 when the first needle member 21 is moved to the most proximal side. The first needle member 21 is movable to a position proximal to the tip of the second needle member 22 and distal to the distal end of the recess 11 of the housing 10 . can be configured to be movable to a position distal to the tip of the first needle member 21 and proximal to the proximal end of the concave portion 11 of the housing 10 . Thus, the first needle member 21 can feed the thread 60 from the proximal side to the distal side, and the second needle member 22 can feed the thread 60 from the distal side to the proximal side.

遠近方向xから見て、第1針部材21と第2針部材22が互いに重なっていることが好ましく、第1針部材21の遠近方向の軸中心と第2針部材22の遠近方向の軸中心とが一致することがより好ましい。遠近方向xから見て、第1針部材21と第2針部材22が互いに重なっているとは、第1針部材21と第2針部材22とが、遠近方向xにおいて、同一直線上にあることを意味する。この場合、第1針部材21の全体と第2針部材22の全体とが同一直線上になくてもよいが、第1針部材21の先端と第2針部材22の先端とが同一直線上にあることが好ましい。これは、第1針部材21の先端と第2針部材22の先端とが向かい合っている状態であるともいえる。このように針部材20を配置することにより、第1針部材21によって遠位側に移動した糸60は、第2針部材22の先端付近に配置されやすくなり、第2針部材22によって近位側に移動した糸60は、第1針部材21の先端付近に配置されやすくなる。このため、第1針部材21と第2針部材22の間で糸60の授受を行いやすくなる。 It is preferable that the first needle member 21 and the second needle member 22 overlap each other when viewed in the perspective direction x, and the axial center of the first needle member 21 and the axial center of the second needle member 22 are aligned. more preferably match. When viewed in the perspective direction x, the first needle member 21 and the second needle member 22 overlapping each other means that the first needle member 21 and the second needle member 22 are on the same straight line in the perspective direction x. means that In this case, the entire first needle member 21 and the entire second needle member 22 do not have to be on the same straight line, but the tip of the first needle member 21 and the tip of the second needle member 22 are on the same straight line. preferably in It can also be said that this is a state in which the tip of the first needle member 21 and the tip of the second needle member 22 face each other. By arranging the needle members 20 in this way, the thread 60 moved distally by the first needle member 21 is more likely to be arranged in the vicinity of the tip of the second needle member 22 , and is moved proximally by the second needle member 22 . The thread 60 that has moved to the side is more likely to be arranged near the tip of the first needle member 21 . Therefore, it becomes easier to transfer the thread 60 between the first needle member 21 and the second needle member 22 .

針部材20は、生体適合性を有し、加えて生体組織等の対象物を穿刺可能な強度を有していることが好ましく、例えば、ステンレス等の金属材料や樹脂材料から構成されていることが好ましく、特に抗錆性や加工の容易性の観点からステンレスであることが好ましい。 The needle member 20 preferably has biocompatibility and also has strength enough to pierce an object such as a living tissue, and is made of, for example, a metal material such as stainless steel or a resin material. is preferable, and stainless steel is particularly preferable from the viewpoint of rust resistance and ease of processing.

針部材20は、直線状、曲線状またはこれらの組み合わせによる形状であってもよい。針部材20は折り曲げ部を有していてもよい。図1では、第2針部材22に折り曲げ部が設けられている例を示している。折り曲げ部を設けることにより、第2針部材22と操作部を接続することができる。図示していないが、針部材20には折り曲げ部が設けられず、第2針部材22の遠位端部に、筐体10の遠近方向xと垂直な方向に延在している接続部材が設けられて、接続部材を介して第2針部材22が操作部に接続されていてもよい。 The needle member 20 may be straight, curved, or a combination thereof. Needle member 20 may have a bent portion. FIG. 1 shows an example in which the second needle member 22 is provided with a bent portion. By providing the bent portion, the second needle member 22 and the operating portion can be connected. Although not shown, the needle member 20 is not provided with a bent portion, and a connection member extending in a direction perpendicular to the far-near direction x of the housing 10 is provided at the distal end of the second needle member 22 . provided, and the second needle member 22 may be connected to the operating portion via a connecting member.

針部材20は中空状または中実状であることが好ましく、針部材20の製造の容易性および高強度化の観点からは中実状であることがより好ましい。 The needle member 20 is preferably hollow or solid, and more preferably solid from the viewpoint of ease of manufacture of the needle member 20 and increased strength.

針部材20の長さは、例えばTSS用の装置では鼻腔から下垂体までの距離である1.5mm以上40cm以下に設定できる。針部材20の長さが、筐体10のうち体内に挿入される部分の長さより短い場合、一または複数の接続部材を介して針部材20を操作部に接続することができる。遠近方向xにおける第1針部材21と第2針部材22の長さは、同じでも異なっていてもよいが、凹部11よりも遠位側において装置1が過度に長くならないように、第2針部材22は第1針部材21よりも短いことが好ましい。 The length of the needle member 20 can be set to 1.5 mm or more and 40 cm or less, which is the distance from the nasal cavity to the pituitary gland in a TSS device, for example. If the length of the needle member 20 is shorter than the length of the portion of the housing 10 that is to be inserted into the body, the needle member 20 can be connected to the operating portion via one or more connecting members. The lengths of the first needle member 21 and the second needle member 22 in the distal direction x may be the same or different. Member 22 is preferably shorter than first needle member 21 .

針部材20の外径は、一般的な縫合針で使用される径であれば特に限定されないが、例えば、0.05mm以上1.5mm以下であることが好ましい。中空状の針部材20の肉厚は、例えば0.01mm以上0.5mm以下であることが好ましい。 The outer diameter of the needle member 20 is not particularly limited as long as it is a diameter used for a general suture needle, but is preferably 0.05 mm or more and 1.5 mm or less, for example. The thickness of the hollow needle member 20 is preferably, for example, 0.01 mm or more and 0.5 mm or less.

第1針部材21と第2針部材22の先端形状について図4~図6を用いて説明する。図4は図1~図3に示した第1針部材21の遠位側を拡大した側面図を表し、図5~図6は図4に示した第1針部材21の側面図の変形例を表す。図4~図6では、第1針部材21を用いて説明するが、第2針部材22も同様に構成することができる。 The tip shapes of the first needle member 21 and the second needle member 22 will be described with reference to FIGS. 4 to 6. FIG. 4 shows an enlarged side view of the distal side of the first needle member 21 shown in FIGS. 1 to 3, and FIGS. 5 and 6 are modifications of the side views of the first needle member 21 shown in FIG. represents 4 to 6, the first needle member 21 is used for explanation, but the second needle member 22 can be similarly constructed.

図4に示すように、針部材20の先端に穿刺部23が設けられていることが好ましい。尖った穿刺部23は、縫合対象物70を穿刺しやすい。穿刺部23は、先端側に向かって尖った1つもしくは複数の鋭利先端を備えていればよい。例えば、第1針部材21は遠位側に向かって断面積が減少するように形成し、第2針部材22は近位側に向かって断面積が減少するように形成することにより、穿刺部23とすることができる。穿刺部23を構成する傾斜面は針部材20の外表面側に配置されていてもよく、内表面側に形成されていてもよい。穿刺部23を構成する傾斜面が内表面側に配置されている場合、穿刺部23において針部材20の外径は一定であってもよい。 As shown in FIG. 4, it is preferable that a puncture section 23 is provided at the distal end of the needle member 20 . The sharp puncturing portion 23 easily punctures the object 70 to be sutured. Puncture section 23 may be provided with one or a plurality of sharp tips pointed toward the tip side. For example, the cross-sectional area of the first needle member 21 decreases toward the distal side, and the cross-sectional area of the second needle member 22 decreases toward the proximal side. 23. The inclined surface forming puncture portion 23 may be arranged on the outer surface side of needle member 20 or may be formed on the inner surface side. In the case where the inclined surface that constitutes the puncture portion 23 is arranged on the inner surface side, the outer diameter of the needle member 20 may be constant at the puncture portion 23 .

針部材20には糸60を掛ける部分が好ましく設けられる。例えば、図4に示すように針部材20には遠近方向xと垂直な方向に貫通している貫通孔24が設けられていることが好ましい。中でも、針部材20の先端を含む部分(以下、「先端部」という)に貫通孔24が設けられていることが好ましい。また、貫通孔24は、針部材20の遠近方向xに沿って延在していることがより好ましい。これにより、貫通孔24を通じて針部材20の先端部に糸60を掛けることができる。針部材20を二又にすることにより、貫通孔24を設けることができる。 The needle member 20 is preferably provided with a portion on which the thread 60 is hooked. For example, as shown in FIG. 4, it is preferable that the needle member 20 is provided with a through hole 24 penetrating in a direction perpendicular to the perspective direction x. Above all, it is preferable that the through-hole 24 is provided in a portion including the tip of the needle member 20 (hereinafter referred to as “tip portion”). Moreover, it is more preferable that the through hole 24 extends along the distance direction x of the needle member 20 . As a result, the thread 60 can be hooked to the tip of the needle member 20 through the through hole 24 . A through hole 24 can be provided by bifurcating the needle member 20 .

針部材20の先端部に貫通孔24が配置される結果、第1針部材21または第2針部材22の先端が、少なくとも第1端部と第2端部の二又に分かれていることが好ましく、第1針部材21の先端21Aが、少なくとも第1端部21Bと第2端部21Cの二又に分かれており、第2針部材22の先端22Aが、少なくとも第1端部22Bと第2端部22Cの二又に分かれていることがより好ましい。これにより、針部材20の製造容易性と糸60の移動容易性を両立することができる。図4では、第1針部材21の先端21Aが第1端部21Bと第2端部21Cの二又に分かれている例を示している。図示していないが、第1針部材21および第2針部材22の先端21A、22Aは、3つ以上または4つ以上に分かれていてもよい。この場合、貫通口24が複数存在するともいえる。これにより、針部材20の先端に糸60が引っ掛かりやすくなる。 As a result of arranging the through hole 24 at the tip of the needle member 20, the tip of the first needle member 21 or the second needle member 22 is divided into at least a first end and a second end. Preferably, the distal end 21A of the first needle member 21 is bifurcated into at least a first end portion 21B and a second end portion 21C, and the distal end portion 22A of the second needle member 22 is bifurcated into at least the first end portion 22B and the second end portion 21C. More preferably, it is divided into two ends 22C. As a result, both the ease of manufacture of the needle member 20 and the ease of movement of the thread 60 can be achieved. FIG. 4 shows an example in which the tip 21A of the first needle member 21 is bifurcated into a first end portion 21B and a second end portion 21C. Although not shown, the distal ends 21A and 22A of the first needle member 21 and the second needle member 22 may be divided into three or more or four or more. In this case, it can be said that there are a plurality of through holes 24 . This makes it easier for the thread 60 to get caught on the tip of the needle member 20 .

遠近方向xから針部材20を見たときに、第1端部と第2端部は針部材20の外周上またはその内側に設けられていることが好ましく、第1端部と第2端部は針部材20の外周上であって軸中心を挟んで対向する位置に設けられていることがより好ましい。このように第1端部と第2端部を配置することにより、針部材20の外周を横断するように糸60が掛けられるため、針部材20から糸60が外れにくくなる。 The first end and the second end are preferably provided on or inside the outer periphery of the needle member 20 when the needle member 20 is viewed from the perspective direction x. are preferably provided on the outer periphery of the needle member 20 at opposing positions across the center of the shaft. By arranging the first end portion and the second end portion in this way, the thread 60 is hung so as to cross the outer periphery of the needle member 20 , so that the thread 60 is less likely to come off the needle member 20 .

針部材20の中心軸に対して垂直な方向から見て、第1端部と第2端部の二又に分かれている部分が、V字形状(図4)であってもよく、U字形状(図5および図6)であってもよい。例えば凹凸状、波状や線対称でない形状であってもよい。二又に分かれている部分の基端部21Dにおける上下方向yの高さが糸60の外径よりも小さいことが好ましい。これにより、基端部21Dで糸60を挟むことができるため、針部材20で糸60を保持しやすくなる。他方、上記基端部21Dにおける上下方向yの高さが、糸60の外径よりも大きくてもよい。これにより、基端部21Dに挟まれることによって糸60が変形することを防げる。針部材20の第1端部と第2端部とは、遠近方向xにおいて遠位側の端部の位置が同じであってもよく、異なっていてもよい。第1端部または第2端部のいずれか一方を長くすることで、縫合対象物70を穿刺しやすくなる。 When viewed from the direction perpendicular to the central axis of the needle member 20, the bifurcated portion of the first end and the second end may be V-shaped (FIG. 4) or U-shaped. It may be in the shape (FIGS. 5 and 6). For example, it may be uneven, wavy, or non-symmetrical. It is preferable that the height in the vertical direction y at the base end portion 21</b>D of the bifurcated portion is smaller than the outer diameter of the thread 60 . As a result, the thread 60 can be pinched by the base end portion 21D, so that the needle member 20 can easily hold the thread 60. As shown in FIG. On the other hand, the height of the base end portion 21D in the vertical direction y may be larger than the outer diameter of the thread 60. As shown in FIG. This prevents the thread 60 from being deformed by being pinched by the base end portion 21D. The first end and the second end of the needle member 20 may have the same or different positions on the distal side in the far-near direction x. Lengthening either the first end or the second end makes it easier to puncture the object 70 to be sutured.

針部材20の糸60を掛ける部分の他の実施態様として、貫通孔24は、針部材20の先端よりも基端側に設けられていてもよい。その場合、貫通孔24は針部材20の半径方向に沿って延在していることが好ましい。このような位置に貫通孔24を設けることによっても針部材20に糸60を掛けることができる。貫通孔24は、針部材20の周方向に沿って形成されていてもよい。なお、本発明では、中空状の針部材20の外周面に現われていない、遠近方向xに沿って貫通している内腔は貫通孔24としては定義されない。 As another embodiment of the portion of the needle member 20 on which the thread 60 is hooked, the through hole 24 may be provided closer to the proximal end than the distal end of the needle member 20 . In that case, the through hole 24 preferably extends along the radial direction of the needle member 20 . The thread 60 can also be hung on the needle member 20 by providing the through hole 24 at such a position. The through hole 24 may be formed along the circumferential direction of the needle member 20 . In addition, in the present invention, the lumen penetrating along the perspective direction x, which does not appear on the outer peripheral surface of the hollow needle member 20, is not defined as the through hole 24.

針部材20を外周面から見たときの貫通孔24の形状は、特に限定されず、例えば直線状、曲線状、またはこれらの組み合わせにすることができる。 The shape of the through hole 24 when the needle member 20 is viewed from the outer peripheral surface is not particularly limited, and can be linear, curved, or a combination thereof, for example.

筐体10の遠近方向xに対して垂直な断面で、第1針部材21と第2針部材22は装置1の重心よりも上方向y1に配置されていることが好ましい。上下方向yに対してこのように針部材20を配置することにより、縫合位置を視認しやすくなる。また、縫合対象物70の開口部の周縁からより離れた位置に縫合糸60を通すことができるため、縫合対象物70の開口部の周縁が切れて糸が外れることを防止できる。また、筐体10内のスペースを有効活用するために、装置1の重心よりも下方向y2に第2針部材22を可動させる部材が配置されていることが好ましい。 It is preferable that the first needle member 21 and the second needle member 22 are arranged above the center of gravity of the device 1 in the direction y1 in a cross section perpendicular to the perspective direction x of the housing 10 . By arranging the needle members 20 in the vertical direction y in this way, it becomes easier to visually recognize the stitching position. In addition, since the suture thread 60 can be passed through a position farther from the periphery of the opening of the sutured object 70, it is possible to prevent the thread from coming off due to cutting of the periphery of the opening of the sutured object 70. Further, in order to effectively utilize the space in the housing 10, it is preferable that a member for moving the second needle member 22 is arranged in the downward direction y2 relative to the center of gravity of the device 1. FIG.

図示していないが、他の部材と組み合わせることによって、針部材20に糸60の保持および解除機能を付与してもよい。例えば、針部材20が貫通孔24を有しており、針部材20が内腔に挿通されている外筒部材が設けられていてもよい。また、別の態様として、中空状の針部材20が貫通孔24を有しており、針部材20の内腔に内挿部材が配置されていてもよい。外筒部材および内挿部材は、いずれも針部材20の遠近方向xに沿って延在している部材である。貫通孔24に掛けられた糸60を外筒部材または内挿部材で押さえることができるため、針部材20から糸60が脱落することを防げる。また、貫通孔24に掛けられた糸60を外筒部材または内挿部材で押し出すことで、針部材20から糸60を解除することも可能である。 Although not shown, the needle member 20 may be provided with the functions of holding and releasing the thread 60 by being combined with other members. For example, the needle member 20 may have a through hole 24, and an outer cylinder member may be provided through which the needle member 20 is inserted through the lumen. As another aspect, the hollow needle member 20 may have a through hole 24 and an insertion member may be arranged in the lumen of the needle member 20 . Both the outer cylinder member and the insertion member are members extending along the distance direction x of the needle member 20 . Since the thread 60 hooked on the through-hole 24 can be held by the outer cylindrical member or the inserting member, the thread 60 can be prevented from falling out of the needle member 20 . It is also possible to release the thread 60 from the needle member 20 by pushing out the thread 60 hooked on the through-hole 24 with an outer cylindrical member or an inserting member.

縫合装置1は、第1針部材21よりも遠位側に配置されている第1糸保持機構31と、第2針部材22の先端と第1糸保持機構31の遠位端の間に配置されている第2糸保持機構32と、を有していることが好ましく、縫合装置1は、少なくとも一部が第1針部材21よりも遠位側に移動可能に配置され、かつ第2針部材22よりも近位側に配置されている第1糸保持機構31と、少なくとも一部が第2針部材22の先端と第1糸保持機構31の遠位端の間に配置されている第2糸保持機構32と、を有していることがより好ましい。以下では、第1糸保持機構31と第2糸保持機構32をまとめて「糸保持機構30」ということがある。第1糸保持機構31は第1針部材21の少なくとも一部よりも遠位側で糸60を保持し、第2糸保持機構32は第2針部材22の少なくとも一部よりも近位側で糸60を保持するために設けられる。これにより、糸保持機構30で糸60が保持されるため、装置1を移動させたときに縫合対象物70から糸60が抜ける、または装置1から糸60が外れることを防げる。 The suturing device 1 includes a first thread holding mechanism 31 arranged distally of the first needle member 21 , and arranged between the tip of the second needle member 22 and the distal end of the first thread holding mechanism 31 . and a second thread holding mechanism 32, wherein at least a part of the suturing device 1 is arranged movably distally of the first needle member 21, and the second needle A first thread holding mechanism 31 arranged proximal to the member 22 and a first thread holding mechanism 31 arranged at least partially between the tip of the second needle member 22 and the distal end of the first thread holding mechanism 31 . It is more preferable to have two thread holding mechanisms 32 . Hereinafter, the first thread holding mechanism 31 and the second thread holding mechanism 32 may be collectively referred to as the "thread holding mechanism 30". The first thread retaining mechanism 31 retains the thread 60 distal to at least a portion of the first needle member 21 and the second thread retaining mechanism 32 proximal to at least a portion of the second needle member 22 . Provided to hold thread 60 . Accordingly, since the thread 60 is held by the thread holding mechanism 30 , the thread 60 can be prevented from slipping out of the object to be sewn 70 or detached from the device 1 when the device 1 is moved.

縫合装置1は、第1針部材21の遠位端よりも近位側に配置されている第1糸保持機構31と、第1糸保持機構31に接続されており、第1糸保持機構31の少なくとも一部を第1針部材21の遠位端よりも遠位側に移動させる移動機構(以下、「第1移動機構」という)とを含むことが好ましい。第1移動機構により、第1糸保持機構31を第1針部材21よりも遠位側に移動させることができるため、第1針部材21で糸60を把持することができる。 The suturing device 1 is connected to the first thread holding mechanism 31 arranged proximal to the distal end of the first needle member 21 and the first thread holding mechanism 31 . and a moving mechanism (hereinafter referred to as “first moving mechanism”) that moves at least part of the distal end of the first needle member 21 to the distal side. Since the first moving mechanism can move the first thread holding mechanism 31 further to the distal side than the first needle member 21 , the thread 60 can be gripped by the first needle member 21 .

縫合装置1は、第2糸保持機構32を移動させる移動機構(以下、「第2移動機構」という)を備えていてもよい。第2糸保持機構32が第2針部材22の近位端よりも近位側に配置されている場合、第2移動機構は、第2糸保持機構32に接続されており、第2糸保持機構32の少なくとも一部を第2針部材32の近位端よりも近位側であって、第1針部材31の遠位端より遠位側に移動させる機構とすることができる。その他に、第2糸保持機構32が第2針部材22の近位端よりも遠位側に配置されている場合も、第2移動機構は、第2糸保持機構32に接続されており、第2糸保持機構32の少なくとも一部を第2針部材32の近位端よりも近位側であって、第1針部材31の遠位端より遠位側に移動させる機構とすることができる。 The suturing device 1 may include a moving mechanism (hereinafter referred to as a "second moving mechanism") that moves the second thread holding mechanism 32. As shown in FIG. When the second thread holding mechanism 32 is arranged proximally of the proximal end of the second needle member 22, the second moving mechanism is connected to the second thread holding mechanism 32 and the second thread holding mechanism At least a portion of mechanism 32 may be a mechanism that moves proximal to the proximal end of second needle member 32 and distal to the distal end of first needle member 31 . In addition, even when the second thread holding mechanism 32 is arranged distally of the proximal end of the second needle member 22, the second moving mechanism is connected to the second thread holding mechanism 32, At least part of the second thread holding mechanism 32 may be moved proximally of the proximal end of the second needle member 32 and distally of the distal end of the first needle member 31 . can.

第1移動機構または第2移動機構の構成は、装置1の近位側に設けられる操作部と接続されていれば特に限定されず、一または複数の部材から構成されていてもよく、第1糸保持機構31または第2糸保持機構32と一体的に形成されていてもよい。第1移動機構または第2移動機構は、例えば、後述する接続部材36のように構成することができる。 The configuration of the first moving mechanism or the second moving mechanism is not particularly limited as long as it is connected to the operation section provided on the proximal side of the device 1, and may be composed of one or more members. It may be formed integrally with the thread holding mechanism 31 or the second thread holding mechanism 32 . The first moving mechanism or the second moving mechanism can be configured, for example, as a connecting member 36 to be described later.

糸保持機構30は、1つの部材から構成されていてもよく、複数の部材を組み合わせて構成されていてもよい。筐体10は、糸保持機構30を保持可能に構成されている。糸保持機構30は、筐体10内または筐体10外に設けられていてもよく、筐体10の凹部11に設けられていてもよい。 The thread holding mechanism 30 may be composed of one member, or may be composed of a combination of a plurality of members. The housing 10 is configured to be able to hold the thread holding mechanism 30 . The thread holding mechanism 30 may be provided inside or outside the housing 10 , or may be provided in the recess 11 of the housing 10 .

糸保持機構30の材質は、生体適合性を有していることが好ましく、例えば、ステンレス等の金属材料や樹脂材料であることがより好ましく、抗錆性や加工の容易性の観点からはステンレスであることがさらに好ましい。 The material of the thread holding mechanism 30 preferably has biocompatibility. For example, it is more preferable to use a metal material such as stainless steel or a resin material. is more preferable.

以下では、糸保持機構30の実施態様について説明する。以下の図面では第1糸保持機構31と第2糸保持機構32は同じ態様である例を示しているが、異なる態様とすることも勿論可能である。 Embodiments of the thread holding mechanism 30 will be described below. Although the following drawings show an example in which the first thread holding mechanism 31 and the second thread holding mechanism 32 have the same aspect, they can of course have different aspects.

図7~図8を参照しながら、糸保持機構30を回転させて糸60を引っ掛けたり押さえ付けたりすることによって糸60を保持する態様について説明する。図7~図8は、回転する糸保持機構30を有する装置1の説明図を表し、図7(a)および図8(a)は、装置1の遠位側の内部の斜視図を表し、図7(b)および図8(b)は装置1の遠位側の断面図(一部側面図)を表している。 A mode of holding the thread 60 by rotating the thread holding mechanism 30 to hook or hold the thread 60 will be described with reference to FIGS. 7 and 8. FIG. Figures 7-8 represent illustrations of the device 1 with a rotating thread retention mechanism 30, Figures 7(a) and 8(a) represent perspective views of the distal interior of the device 1, 7(b) and 8(b) show a cross-sectional view (partial side view) of the distal side of the device 1. FIG.

糸保持機構30の形状は特に限定されないが、例えば、図7に示すように、回転軸33と固定部34と糸当接部35を有するように構成することができる。すなわち、装置1は、近位側に操作部を有し、第1糸保持機構31は、第1方向を軸とする回転軸33と、回転軸33を挟んだ一方側に設けられており、操作部に直接または間接的に固定されている固定部34と、回転軸33を挟んだ他方側に設けられており、糸60が当接する糸当接部35と、を有することが好ましい。第1糸保持機構31を回転させることにより、縫合対象物70よりも近位側で糸60と当接して糸60を把持することができる。同様に、第2糸保持機構32は、第1方向を軸とする回転軸33と、回転軸33を挟んだ一方側に設けられており、操作部に直接または間接的に固定されている固定部34と、回転軸33を挟んだ他方側に設けられており、糸60が当接する糸当接部35と、を有することが好ましい。第2糸保持機構32を回転させることにより、縫合対象物70よりも遠位側で糸60と当接して糸60を保持することができる。なお、図7(a)では、固定部34を省略して記載している。 Although the shape of the thread holding mechanism 30 is not particularly limited, for example, as shown in FIG. That is, the device 1 has an operation portion on the proximal side, and the first thread holding mechanism 31 is provided on one side of the rotating shaft 33 having the axis in the first direction and the rotating shaft 33 interposed therebetween, It is preferable to have a fixed portion 34 directly or indirectly fixed to the operation portion, and a thread contact portion 35 provided on the other side of the rotating shaft 33 and with which the thread 60 contacts. By rotating the first thread holding mechanism 31 , the thread 60 can be held in contact with the thread 60 on the proximal side of the suture object 70 . Similarly, the second thread holding mechanism 32 is provided on one side of a rotating shaft 33 whose axis is in the first direction, and on either side of the rotating shaft 33, and is fixed directly or indirectly to the operating portion. It is preferable to have a portion 34 and a thread contact portion 35 which is provided on the other side of the rotating shaft 33 and with which the thread 60 contacts. By rotating the second thread holding mechanism 32 , the thread 60 can be held in contact with the thread 60 on the distal side of the suture object 70 . Note that the fixing portion 34 is omitted in FIG. 7(a).

第1糸保持機構31と第2糸保持機構32の少なくともいずれか一方が、遠近方向xに沿って移動可能であることが好ましく、第1糸保持機構31および第2糸保持機構32が、遠近方向xに沿って移動可能であることが好ましい。これにより、第1糸保持機構31または第2糸保持機構32が針部材20の動きに追従するため、針部材20の先端付近にある糸60を保持しやすくなる。 At least one of the first thread holding mechanism 31 and the second thread holding mechanism 32 is preferably movable along the perspective direction x. It is preferably movable along direction x. As a result, since the first thread holding mechanism 31 or the second thread holding mechanism 32 follows the movement of the needle member 20, the thread 60 near the tip of the needle member 20 can be easily held.

第1糸保持機構31と第2糸保持機構32の少なくともいずれか一方が、遠近方向xにおいて固定されていてもよい。例えば、第1糸保持機構31が遠近方向xに沿って移動可能であり、第2糸保持機構32は遠近方向xに沿って移動しない態様とすることができる。このように糸保持機構30の可動域を限定することにより、筐体10の凹部11よりも遠位側の部分が過度に長くなることを防ぐことができる。 At least one of the first thread holding mechanism 31 and the second thread holding mechanism 32 may be fixed in the perspective direction x. For example, the first thread holding mechanism 31 can move along the perspective direction x, and the second thread holding mechanism 32 can be configured not to move along the perspective direction x. By limiting the movable range of the thread holding mechanism 30 in this way, it is possible to prevent the portion of the housing 10 on the distal side from the concave portion 11 from becoming excessively long.

固定部34は、一または複数の接続部材36を介して近位側の操作部と接続されていることが好ましい。接続部材36は、筐体10内または筐体10外に配置することができるが、筐体10内に配置されていることが好ましい。固定部34と接続部材36との接続は、例えば、嵌合、ねじ、カシメ等による機械的な固定、レーザーや金属ロウ等による溶接、ポリウレタン系、エポキシ系、シアノ系、シリコーン系等の接着剤を用いた接着等の方法を用いることができる。接続部材36の形状や個数は、糸当接部35を回転することができれば特に限定されないが、接続部材36は筐体10の遠近方向xに沿って延在している部分を有していることが好ましい。これにより、操作部と接続しやすくなる。接続部材36は長板状であってもよく、ワイヤーのように線状または棒状であってもよい。縫合を行いやすくするために、接続部材36は、針部材20よりも下側に配置されていることが好ましい。 The fixed part 34 is preferably connected to the proximal side operation part via one or more connecting members 36 . The connection member 36 can be arranged inside the housing 10 or outside the housing 10 , but is preferably arranged inside the housing 10 . The connection between the fixed part 34 and the connecting member 36 is achieved by, for example, mechanical fixing such as fitting, screwing, or caulking, welding using a laser or metal brazing, or an adhesive such as polyurethane, epoxy, cyano, or silicone. A method such as adhesion using a can be used. The shape and number of the connection members 36 are not particularly limited as long as the thread abutting portion 35 can be rotated, but the connection members 36 have a portion extending along the perspective direction x of the housing 10 . is preferred. This facilitates connection with the operation unit. The connecting member 36 may be in the form of a long plate, or in the form of a wire or rod. The connecting member 36 is preferably arranged below the needle member 20 in order to facilitate suturing.

糸当接部35は、例えば、板状や塊状や棒状に形成することができるが、軽量化の観点からは板状もしくは棒状であることが好ましい。糸当接部35は、糸60と接触しやすい第1主面35Aと、その反対側の第2主面35Bと、側面35Cを有している。糸当接部35の外表面は、平坦であっても凹凸が設けられていてもよい。糸60の脱落を防ぐためには、糸当接部35の第1主面35Aと側面35Cの少なくともいずれか一方に凹凸が設けられていることが好ましい。糸当接部35には、糸60を把持しやすくするための溝や突起が設けられていてもよい。 The thread contact portion 35 can be formed in a plate shape, a block shape, or a rod shape, for example, but the plate shape or rod shape is preferable from the viewpoint of weight reduction. The thread abutting portion 35 has a first main surface 35A that easily contacts the thread 60, a second main surface 35B on the opposite side, and a side surface 35C. The outer surface of the thread abutting portion 35 may be flat or uneven. In order to prevent the thread 60 from falling off, it is preferable that at least one of the first main surface 35A and the side surface 35C of the thread contact portion 35 is provided with unevenness. The thread abutting portion 35 may be provided with grooves or protrusions for facilitating gripping of the thread 60 .

糸60を保持する際には、図7に示すように、第1糸保持機構31の糸当接部35の第1主面35Aが近位側を向いており、第2主面35Bが遠位側を向いていることが好ましい。これにより、糸保持機構30によって針部材20の先端付近にある糸60を保持することができる。同様に、糸60を保持する際には、第2糸保持機構32の糸当接部35の第1主面35Aが遠位側を向いており、第2主面35Bが近位側を向いていることが好ましい。 When holding the thread 60, as shown in FIG. 7, the first main surface 35A of the thread contact portion 35 of the first thread holding mechanism 31 faces the proximal side, and the second main surface 35B faces the far side. It is preferably facing the position side. As a result, the thread 60 near the tip of the needle member 20 can be held by the thread holding mechanism 30 . Similarly, when holding the thread 60, the first principal surface 35A of the thread contact portion 35 of the second thread holding mechanism 32 faces distally, and the second principal surface 35B faces proximally. preferably.

糸60の保持解除は次のように行うことができる。図8(b)に示すように、第2糸保持機構32の固定部34に接続されている接続部材36を遠位側に移動させると、第2糸保持機構32では、回転軸33よりも遠位側に固定部34が配置され、近位側に糸当接部35が配置される。このとき、糸当接部35の第1主面35Aは上側を向き、第2主面35Bは下側を向く。同様に、第1糸保持機構31の固定部34に接続されている接続部材36を近位側に移動させると、第1糸保持機構31では、回転軸33よりも近位側に固定部34が配置され、遠位側に糸当接部35が配置される。このとき、糸当接部35の第1主面35Aが上側を向き、第2主面35Bが下側を向く。 The thread 60 can be released as follows. As shown in FIG. 8(b), when the connecting member 36 connected to the fixing portion 34 of the second thread holding mechanism 32 is moved distally, the second thread holding mechanism 32 moves toward the rotation shaft 33. A fixing portion 34 is arranged on the distal side, and a thread contact portion 35 is arranged on the proximal side. At this time, the first principal surface 35A of the thread contact portion 35 faces upward, and the second principal surface 35B faces downward. Similarly, when the connection member 36 connected to the fixed portion 34 of the first thread holding mechanism 31 is moved proximally, the fixed portion 34 is moved proximally of the rotating shaft 33 in the first thread holding mechanism 31 . is arranged, and the thread contact part 35 is arranged on the distal side. At this time, the first principal surface 35A of the thread contact portion 35 faces upward, and the second principal surface 35B faces downward.

糸保持機構30の回転方向は特に限定されない。筐体10は、第1針部材21と第2針部材22との間における遠近方向xと垂直な断面において、装置1の重心から第1針部材21の中心軸に向かう上方向y1と、中心軸から重心に向かう下方向y2を有しており、第1糸保持機構31または第2糸保持機構32は、上下方向y以外の第1方向を軸として回転することが好ましい。このように糸保持機構30の回転軸方向を設定することにより、糸60が糸保持機構30に引っ掛かりやすくなる。 The rotation direction of the thread holding mechanism 30 is not particularly limited. In a cross section perpendicular to the perspective direction x between the first needle member 21 and the second needle member 22, the housing 10 has an upward direction y1 from the center of gravity of the device 1 toward the central axis of the first needle member 21 and a center The first thread holding mechanism 31 or the second thread holding mechanism 32 preferably rotates about the first direction other than the vertical direction y. By setting the rotation axis direction of the thread holding mechanism 30 in this manner, the thread 60 is easily caught by the thread holding mechanism 30 .

第1方向が、遠近方向x、または上下方向yおよび遠近方向xの両方に垂直な方向であることが好ましい。このように糸保持機構30の回転軸方向を上記第1方向に設定することにより糸60を把持しやすくなる。なお、図7~図8では、第1方向が上下方向yおよび遠近方向xの両方に垂直な方向である例を示している。 Preferably, the first direction is the perspective direction x, or a direction perpendicular to both the up-down direction y and the perspective direction x. By setting the rotation axis direction of the thread holding mechanism 30 in the first direction, the thread 60 can be easily gripped. 7 and 8 show examples in which the first direction is perpendicular to both the vertical direction y and the perspective direction x.

図示していないが、図7~図8の変形例として、糸保持機構30は、糸60が当接する糸当接部35と、糸当接部35を回転させる回転軸33を有し、糸当接部35が操作部に直接または間接的に接続されている固定部34を有していてもよい。この場合、糸当接部35が板状であり、糸当接部35の第2主面35Bに接続部材36の遠位端部を固定する固定部34が設けられていることが好ましい。 Although not shown, as a modification of FIGS. 7 and 8, the thread holding mechanism 30 has a thread contact portion 35 with which the thread 60 abuts, and a rotary shaft 33 for rotating the thread contact portion 35. The contact portion 35 may have a fixed portion 34 directly or indirectly connected to the operating portion. In this case, it is preferable that the thread contact portion 35 is plate-shaped, and the fixing portion 34 for fixing the distal end portion of the connecting member 36 is provided on the second main surface 35B of the thread contact portion 35 .

図示していないが、第1糸保持機構31の糸当接部35は、第1針部材21を挿通可能な貫通口を有していてもよい。同様に、第2糸保持機構32の糸当接部35は、第2針部材22を挿通可能な貫通口を有していてもよい。その場合、貫通口の深さ方向が、針部材20の遠近方向xに沿って延在していることが好ましい。このように糸保持機構30に貫通口を設けることにより、糸保持機構30が針部材20の先端と対向していても、針部材20を遠近方向に移動させることができる。 Although not shown, the thread abutting portion 35 of the first thread holding mechanism 31 may have a through hole through which the first needle member 21 can be inserted. Similarly, the thread abutment portion 35 of the second thread holding mechanism 32 may have a through hole through which the second needle member 22 can be inserted. In that case, the depth direction of the through-hole preferably extends along the perspective direction x of the needle member 20 . By providing the through hole in the thread holding mechanism 30 in this way, even if the thread holding mechanism 30 faces the tip of the needle member 20, the needle member 20 can be moved in the distance direction.

次に、図9~図10を参照しながら糸保持機構30の他の態様について説明する。図9~図10は、針部材20の軸中心に向かって突出する糸保持機構30を有する装置1の説明図を表し、図9(a)および図10(a)は、針部材20と棒状部材37が重なっている状態、図9(b)および図10(b)は針部材20と棒状部材37が重なっていない状態における装置1の遠位側の斜視図を表している。 Next, another aspect of the thread holding mechanism 30 will be described with reference to FIGS. 9 to 10. FIG. 9 to 10 are explanatory diagrams of the device 1 having the thread holding mechanism 30 projecting toward the axial center of the needle member 20. FIGS. 9(b) and 10(b) show perspective views of the distal side of the device 1 with the needle member 20 and rod member 37 not overlapping.

第1糸保持機構31または第2糸保持機構32は、第1針部材21または第2針部材22の軸中心に向かって突出可能である態様とすることもできる。このような態様であっても、第1針部材21または第2針部材22の先端にある糸60を第1糸保持機構31または第2糸保持機構32で保持することができる。 The first thread holding mechanism 31 or the second thread holding mechanism 32 can also be configured to protrude toward the axial center of the first needle member 21 or the second needle member 22 . Even in this mode, the thread 60 at the tip of the first needle member 21 or the second needle member 22 can be retained by the first thread holding mechanism 31 or the second thread holding mechanism 32 .

図9に示すように、糸保持機構30は、操作部に直接または間接的に固定されている固定部34と、糸60が当接する糸当接部35と、を有していてもよい。回転機構を設ける必要がないため、糸保持機構30の可動部での不具合の発生を抑制できる。 As shown in FIG. 9, the thread holding mechanism 30 may have a fixed portion 34 directly or indirectly fixed to the operating portion, and a thread contact portion 35 with which the thread 60 contacts. Since it is not necessary to provide a rotating mechanism, it is possible to suppress the occurrence of malfunctions in the movable portion of the thread holding mechanism 30 .

糸当接部35が、第1方向に沿って移動可能であることが好ましく、上下方向yに沿って移動可能であることがより好ましい。これにより、糸当接部35で糸60を引っ掛けやすくなる。例えば、第1針部材21が後述する第1筒部材41内に配置されており、第1筒部材41の内壁に開口が設けられており、開口から糸当接部35が露出することが好ましい。開口が設けられる位置は特に限定されないが、例えば筐体10の上下方向yの下側に設けることができる。 The thread contact portion 35 is preferably movable along the first direction, and more preferably movable along the vertical direction y. This makes it easier to hook the thread 60 on the thread contact portion 35 . For example, it is preferable that the first needle member 21 is arranged inside a first cylindrical member 41, which will be described later, that an opening is provided in the inner wall of the first cylindrical member 41, and that the thread contact portion 35 is exposed through the opening. . Although the position where the opening is provided is not particularly limited, it can be provided below the housing 10 in the vertical direction y, for example.

固定部34と糸当接部35を有する糸保持機構30の具体的構成としては、図9に示すように糸保持機構30が、筐体10の遠近方向xに沿って延在している棒状部材37である態様が挙げられる。棒状部材37は筐体10内の中空部内に保持されていることが好ましい。また、棒状部材37の遠位端部に糸60を掛ける糸当接部35が設けられていることが好ましい。筐体10の中空部は全体として遠近方向xに延在しており、各棒状部材37の遠位端部は、針部材20の遠近方向xと垂直な方向に向かって曲げられていることが好ましい。棒状部材37の遠位端部は、弾性材料から構成されていることが好ましい。これにより、操作部を操作して棒状部材37を遠位側に移動させると、糸当接部35が筐体10の中空部の形状に沿って湾曲し、糸当接部35に糸60を掛けることができる。 As a specific configuration of the thread holding mechanism 30 having the fixing portion 34 and the thread contact portion 35, the thread holding mechanism 30 is a rod-shaped member extending along the distance direction x of the housing 10 as shown in FIG. An aspect in which the member 37 is provided is included. It is preferable that the rod-shaped member 37 is held in a hollow portion inside the housing 10 . Moreover, it is preferable that a thread abutting portion 35 for hooking the thread 60 is provided at the distal end of the rod-like member 37 . The hollow portion of the housing 10 as a whole extends in the far-near direction x, and the distal end of each rod-shaped member 37 is bent in a direction perpendicular to the far-near direction x of the needle member 20 . preferable. The distal end of rod-shaped member 37 is preferably constructed of an elastic material. As a result, when the operating portion is operated to move the rod-like member 37 distally, the thread contact portion 35 curves along the shape of the hollow portion of the housing 10 , and the thread 60 is attached to the thread contact portion 35 . can be hung.

糸保持機構30の糸当接部35は弾性材料から構成されていることが好ましい。弾性材料としては、例えば、シリコーンゴム、ポリアミドエラストマーなどの有機材料や、ステンレス等の金属材料、またはこれらの組み合わせを用いることもできる。棒状部材37として、弾性ワイヤーや撚り線などを用いることもできる。 The thread contact portion 35 of the thread holding mechanism 30 is preferably made of an elastic material. As the elastic material, for example, an organic material such as silicone rubber or polyamide elastomer, a metal material such as stainless steel, or a combination thereof can be used. An elastic wire, a stranded wire, or the like can also be used as the rod-shaped member 37 .

図9に示した実施態様の変形例として、図10に示すように針部材20と棒状部材37が重なっていない状態で、棒状部材37が、筐体10の上下方向yに沿って延在している部分を有していてもよく、棒状部材37の遠位端部が、筐体10の上下方向yに沿って延在しており、かつ筐体10の上下方向yに沿って移動可能であることが好ましい。その場合、棒状部材37の遠位端部は、剛性材料もしくは弾性材料から構成されていることが好ましい。これにより、操作部を操作して棒状部材37を上方向y1に移動させると、糸当接部35が針部材20の軸中心に向かって突出し、糸当接部35に糸60を掛けることができる。 As a modification of the embodiment shown in FIG. 9, the rod-shaped member 37 extends along the vertical direction y of the housing 10 in a state in which the needle member 20 and the rod-shaped member 37 do not overlap as shown in FIG. The distal end of the rod-shaped member 37 extends along the vertical direction y of the housing 10 and is movable along the vertical direction y of the housing 10. is preferably In that case, the distal end of rod-like member 37 is preferably made of a rigid or elastic material. Accordingly, when the operating portion is operated to move the rod-shaped member 37 in the upward direction y1, the thread contact portion 35 protrudes toward the axial center of the needle member 20, and the thread 60 can be hooked on the thread contact portion 35. can.

糸保持機構30の糸当接部35は剛性材料もしくは弾性材料から構成されていることが好ましい。弾性材料としては、例えば、シリコーンゴム、ポリアミドエラストマーなどの有機材料や、ステンレス等の金属材料、またはこれらの組み合わせを用いることもできる。剛性材料としては、例えばステンレス等の金属材料、またはこれらの組み合わせを用いることもできる。棒状部材37として、弾性ワイヤーや撚り線などを用いることもできる。 The thread contact portion 35 of the thread holding mechanism 30 is preferably made of a rigid or elastic material. As the elastic material, for example, an organic material such as silicone rubber or polyamide elastomer, a metal material such as stainless steel, or a combination thereof can be used. As the rigid material, for example, a metal material such as stainless steel or a combination thereof can be used. An elastic wire, a stranded wire, or the like can also be used as the rod-shaped member 37 .

図11~図12を参照しながら、糸保持機構30のさらに他の態様について説明する。図11は、糸60を挟む糸保持機構30の説明図を表し、図12は、図11に示す糸保持機構30を有する医療用双方向縫合装置1の説明図であって、装置1の遠位側の断面図(一部側面図)を表している。図11(a)および図12(a)は2つの挟持部材38を離間させた状態、図11(b)および図12(b)は2つの挟持部材38を近接させた状態を示している。 Still another aspect of the thread holding mechanism 30 will be described with reference to FIGS. 11 and 12. FIG. 11 is an explanatory diagram of the thread holding mechanism 30 that clamps the thread 60, and FIG. 12 is an explanatory diagram of the two-way medical suturing device 1 having the thread holding mechanism 30 shown in FIG. FIG. 10 shows a cross-sectional view (partial side view) on the position side. 11(a) and 12(a) show the state in which the two holding members 38 are separated, and FIGS. 11(b) and 12(b) show the state in which the two holding members 38 are brought close to each other.

糸保持機構30は糸60を挟んで保持する態様とすることもできる。図11に示すように、第1糸保持機構31は、対向している2つの挟持部材38を有していてもよい。同様に、第2糸保持機構32も対向している2つの挟持部材38を有していてもよい。2つの挟持部材38を近接させて糸60を挟むことによって糸60を保持することができる。挟持部材38は糸60を保持できる程度の強度を有していればよく、その形状は特に限定されず板状や塊状でもよい。軽量化の観点からは挟持部材38は板状であることが好ましい。 The thread holding mechanism 30 can also be configured to sandwich and hold the thread 60 . As shown in FIG. 11, the first thread holding mechanism 31 may have two clamping members 38 facing each other. Similarly, the second thread holding mechanism 32 may also have two clamping members 38 facing each other. The thread 60 can be held by bringing the two clamping members 38 close together to sandwich the thread 60 . The holding member 38 only needs to have strength enough to hold the thread 60, and its shape is not particularly limited, and may be plate-like or block-like. From the viewpoint of weight reduction, the holding member 38 is preferably plate-shaped.

2つの挟持部材38の対向方向は、図12(a)に示すように筐体10の遠近方向xおよび上下方向yと垂直な方向zに沿っていてもよく、図12(b)に示すように筐体10の遠近方向xに沿っていてもよい。2つの挟持部材38の対向方向が、筐体10の遠近方向xに沿っている場合、2つの挟持部材38は、対向方向に貫通している挿通路38Aを有していることが好ましい。挿通路38Aの最小内径が、針部材20の外径よりも大きいことが好ましい。このように挿通路38Aを設けることにより、針部材20が挿通路38Aを通過することができるため、より一層、針部材20を遠位側または近位側に移動させることができる。2つの挟持部材38の対向方向から見たときに、挿通路38Aは円形状、楕円形状、多角形状、またはこれらを組み合わせた形状にすることができる。なお、図11では、挟持部材38の挿通路38Aを四角形状とした例を示している。挟持部材38は挿通路38Aにつながる切り欠き38Bを有していてもよい。 The opposing direction of the two holding members 38 may be along the direction z perpendicular to the perspective direction x and the vertical direction y of the housing 10 as shown in FIG. may be along the perspective direction x of the housing 10 . When the opposing direction of the two holding members 38 is along the far-near direction x of the housing 10, the two holding members 38 preferably have insertion paths 38A penetrating in the opposing direction. It is preferable that the minimum inner diameter of the insertion passage 38A is larger than the outer diameter of the needle member 20 . By providing the insertion passage 38A in this manner, the needle member 20 can pass through the insertion passage 38A, so that the needle member 20 can be moved further to the distal side or the proximal side. When viewed from the opposing direction of the two clamping members 38, the insertion passage 38A can have a circular shape, an elliptical shape, a polygonal shape, or a combination of these shapes. Note that FIG. 11 shows an example in which the insertion passage 38A of the holding member 38 has a square shape. The clamping member 38 may have a notch 38B leading to the insertion passage 38A.

図11に示すように、2つの挟持部材38には、支持部材39がそれぞれ接続されていることが好ましい。支持部材39は、他の部材と接触することにより撓み、2つの挟持部材38に接続されている2つの支持部材39が互いに近接または離間するように変位してもよい。支持部材39は、例えば断面が円形または多角形の棒状とすることができる。 As shown in FIG. 11, it is preferable that support members 39 are connected to the two holding members 38, respectively. The support member 39 may be deflected by contact with another member and displaced so that the two support members 39 connected to the two clamping members 38 are moved closer to each other or away from each other. The support member 39 can be, for example, a bar with a circular or polygonal cross section.

次に、針部材20を内包する筒部材40が設けられる態様について説明する。図2~図3に示すように、装置1は、さらに、第1針部材21を内包する第1筒部材41と、第2針部材22を内包する第2筒部材42が設けられており、第1筒部材41と第2筒部材42の少なくともいずれか一方が、遠近方向xに沿って移動可能であることが好ましい。また、第1筒部材41および第2筒部材42が、遠近方向xに沿って移動可能であることがより好ましい。以下では第1筒部材41と第2筒部材42をまとめて「筒部材40」ということがある。このように筒部材40が移動可能であることにより、第1筒部材41の遠位端と第2筒部材42の近位端を近接させて縫合対象物70を挟んで張力を付与することができる。これにより、針部材20を縫合対象物70に穿刺しても縫合対象物70が逃げにくくなり、より簡易に縫合対象70を穿刺できかつ意図しない位置に穿刺することを防止できる。筒部材40内で針部材20が移動するために、筒部材40の内径は、針部材20の外径よりも大きい。なお、図2では装置1の内部構成の理解を容易にするために、筒部材40を半円筒状にして示している。以降の斜視図も同様である。 Next, a manner in which the cylindrical member 40 containing the needle member 20 is provided will be described. As shown in FIGS. 2 and 3, the device 1 is further provided with a first tubular member 41 enclosing the first needle member 21 and a second tubular member 42 enclosing the second needle member 22, At least one of the first cylindrical member 41 and the second cylindrical member 42 is preferably movable along the perspective direction x. Moreover, it is more preferable that the first cylindrical member 41 and the second cylindrical member 42 are movable along the perspective direction x. Below, the 1st cylinder member 41 and the 2nd cylinder member 42 may be collectively called "the cylinder member 40." Since the cylinder member 40 is movable in this way, tension can be applied by bringing the distal end of the first cylinder member 41 and the proximal end of the second cylinder member 42 close to sandwich the object 70 to be sutured. can. As a result, even if the needle member 20 punctures the object 70 to be sutured, the object 70 to be sutured does not escape easily, and the object 70 to be sutured can be punctured more easily and can be prevented from being punctured in an unintended position. The inner diameter of the tubular member 40 is larger than the outer diameter of the needle member 20 because the needle member 20 moves within the tubular member 40 . In addition, in FIG. 2, in order to facilitate understanding of the internal configuration of the device 1, the cylindrical member 40 is shown as being semi-cylindrical. The same applies to subsequent perspective views.

第1筒部材41と第2筒部材42は、それぞれ一つもしくは複数の部品によって構成することができる。図7では、第1筒部材41と第2筒部材42ともに、一つの円筒状部品によって構成されている。複数の部品によって構成する例として、筐体10の内壁と一つもしくは複数の部品を組み合わせて筒形状を形成することもできる。 Each of the first cylindrical member 41 and the second cylindrical member 42 can be composed of one or a plurality of parts. In FIG. 7, both the first cylindrical member 41 and the second cylindrical member 42 are configured by one cylindrical part. As an example of configuration with a plurality of parts, the inner wall of the housing 10 and one or more parts can be combined to form a cylindrical shape.

また、筒部材40が針部材20を内包することにより、針部材20で糸60を遠近方向xに沿って移動させたときに、筒部材40の内腔形状に沿って糸60は遠近方向xに折り返される。縫合用の糸60は好ましくはハリ、すなわち適度な剛性を有するため、糸60は筒部材40の内壁に接すると半径方向の外方に広がるように延在する。これにより、糸60の折り返し部61は筒部材40の内腔に収まり、糸60が意図しない方向に移動することを防げる。 In addition, since the needle member 20 is included in the cylindrical member 40 , when the thread 60 is moved in the distance direction x by the needle member 20 , the thread 60 moves along the shape of the lumen of the cylindrical member 40 in the distance direction x. is wrapped to The thread 60 for suturing preferably has a firmness, ie, an appropriate rigidity, so that when the thread 60 comes into contact with the inner wall of the tubular member 40, the thread 60 extends outward in the radial direction. As a result, the folded portion 61 of the thread 60 is accommodated in the inner cavity of the cylindrical member 40, thereby preventing the thread 60 from moving in an unintended direction.

第1筒部材41の遠位端面と第2筒部材42の近位端面が向かい合っていることが好ましい。また、遠近方向xから見て、第1筒部材41の遠位端面と第2筒部材42の近位端面が互いに重なっていることがより好ましい。これにより、第1筒部材41と第2筒部材42で縫合対象物70を挟んで固定しやすくなる。 It is preferable that the distal end surface of the first tubular member 41 and the proximal end surface of the second tubular member 42 face each other. Moreover, it is more preferable that the distal end surface of the first cylindrical member 41 and the proximal end surface of the second cylindrical member 42 overlap each other when viewed in the far-near direction x. As a result, the object to be sewn 70 can be easily sandwiched and fixed between the first cylindrical member 41 and the second cylindrical member 42 .

ここでは第1筒部材41と第2筒部材42によって縫合対象物70を挟んで固定する例を示したが、第1糸保持機構31と第2筒部材42、第2糸保持機構32と第1筒部材41、または第1糸保持機構31と第2糸保持機構32によって縫合対象物70を挟んで固定してもよい。 Here, an example in which the object to be sewn 70 is sandwiched and fixed by the first cylindrical member 41 and the second cylindrical member 42 is shown, but the first thread holding mechanism 31 and the second cylindrical member 42, the second thread holding mechanism 32 and the second thread holding mechanism 32 are shown. The object to be sewn 70 may be sandwiched and fixed by one cylindrical member 41 or by the first thread holding mechanism 31 and the second thread holding mechanism 32 .

遠近方向xにおいて、第1針部材21に対する第1筒部材41の長さおよび第2針部材22に対する第2筒部材42の長さは特に限定されない。 The length of the first cylindrical member 41 with respect to the first needle member 21 and the length of the second cylindrical member 42 with respect to the second needle member 22 in the distance direction x are not particularly limited.

筒部材40は、円筒状、楕円筒状または多角筒状とすることができる。形状や長さは第1筒部材41と第2筒部材42で同じであっても異なっていてもよい。 The cylindrical member 40 can be cylindrical, elliptical, or polygonal. The shape and length of the first cylindrical member 41 and the second cylindrical member 42 may be the same or different.

第1筒部材41の外周面には第1開口41Aが設けられていることが好ましく、第1筒部材41の遠位端部の外周面に第1開口41Aが設けられていることがより好ましい。第1開口41Aを通じて、第1筒部材41の内腔に第1糸保持機構31を配置することができる。同様に、第2筒部材42の外周面に第2開口42Aが設けられていることが好ましく、第2筒部材42の近位端部の外周面に第2開口42Aが設けられていることがより好ましい。第2開口42Aを通じて、第2筒部材42の内腔に第2糸保持機構32を配置することができる。 A first opening 41A is preferably provided on the outer peripheral surface of the first tubular member 41, and more preferably, the first opening 41A is provided on the outer peripheral surface of the distal end portion of the first tubular member 41. . The first thread holding mechanism 31 can be arranged in the lumen of the first cylindrical member 41 through the first opening 41A. Similarly, the second opening 42A is preferably provided on the outer peripheral surface of the second tubular member 42, and the second opening 42A is preferably provided on the outer peripheral surface of the proximal end portion of the second tubular member 42. more preferred. The second thread holding mechanism 32 can be arranged in the lumen of the second tubular member 42 through the second opening 42A.

第1針部材21の先端側にある糸60を第1糸保持機構31で保持しやすくするために、第1開口41Aは、第1筒部材41の遠位端を含む部分に設けられていることが好ましい。同様に、第2針部材22の先端側にある糸60を第2糸保持機構32で保持しやすくするために、第2開口42Aは、第2筒部材42の近位端を含む部分に設けられていることが好ましい。遠近方向xにおける第1開口41Aおよび第2開口42Aの長さは、糸保持機構30の長さに応じて設定することができる。 The first opening 41A is provided in a portion including the distal end of the first cylindrical member 41 so that the first thread holding mechanism 31 can easily hold the thread 60 on the distal end side of the first needle member 21. is preferred. Similarly, the second opening 42A is provided in a portion including the proximal end of the second cylindrical member 42 so that the second thread holding mechanism 32 can easily hold the thread 60 on the distal end side of the second needle member 22. It is preferable that The lengths of the first opening 41A and the second opening 42A in the perspective direction x can be set according to the length of the thread holding mechanism 30. FIG.

糸保持機構30は、筒部材40に設けられていてもよく、筒部材40以外の部材に設けられていてもよい。第1糸保持機構31が第1筒部材41に設けられている構成と、第2糸保持機構32が第2筒部材42に設けられている構成の少なくともいずれか一方の構成を有していることが好ましい。第1糸保持機構31が第1筒部材41に設けられている構成と、第2糸保持機構32が第2筒部材42に設けられている構成の両方を有していることがより好ましい。糸保持機構30が筒部材40に設けられていれば、筒部材40が遠近方向に沿って移動したときに、これに追従して糸保持機構30も遠近方向に沿って移動することができるようになる。 The thread holding mechanism 30 may be provided on the tubular member 40 or may be provided on a member other than the tubular member 40 . At least one of a configuration in which the first thread holding mechanism 31 is provided on the first tubular member 41 and a configuration in which the second thread holding mechanism 32 is provided on the second tubular member 42 is provided. is preferred. It is more preferable to have both a configuration in which the first thread holding mechanism 31 is provided on the first tubular member 41 and a configuration in which the second thread holding mechanism 32 is provided on the second tubular member 42 . If the thread holding mechanism 30 is provided on the cylindrical member 40, when the cylindrical member 40 moves along the distance direction, the thread holding mechanism 30 can also move along the distance direction. become.

筐体10および筒部材40の材質は、糸保持機構30と同様に、ステンレス等の金属材料や樹脂材料であることがより好ましい。 As with the thread holding mechanism 30, the housing 10 and the tubular member 40 are preferably made of a metal material such as stainless steel or a resin material.

次に、ハンドル50に設けられる操作部について図1を参照しながら説明する。装置1は、第1針部材21の近位側と接続されており、第1針部材21を遠近方向xに移動させるための第1操作部51と、第2針部材22の遠位側と接続されており、第2針部材22を遠近方向xに移動させるための第2操作部52と、を有していてもよい。図1は第1操作部51および第2操作部52がレバーの例を示しており、いずれかのレバーを近位側に引くと第1針部材21は遠位側に、第2針部材22は近位側に移動し、レバーを遠位側に戻すと第1針部材21は近位側に、第2針部材22は遠位側に移動するようになっている。 Next, the operating portion provided on the handle 50 will be described with reference to FIG. The device 1 is connected to the proximal side of the first needle member 21, and includes a first operating portion 51 for moving the first needle member 21 in the distance direction x, and the distal side of the second needle member 22. and a second operating portion 52 connected thereto for moving the second needle member 22 in the perspective direction x. FIG. 1 shows an example in which the first operating portion 51 and the second operating portion 52 are levers. When one of the levers is pulled proximally, the first needle member 21 moves distally and the second needle member 22 moves proximally. moves proximally, and when the lever is returned distally, the first needle member 21 moves proximally and the second needle member 22 moves distally.

第1操作部51が第1糸保持機構31にも接続されており、第2操作部52が第2糸保持機構32にも接続されていることが好ましい。これにより、第1操作部51を操作することで第1針部材21と第1糸保持機構31の両方を操作することができる。同様に、第2操作部52を操作することで第2針部材22と第2糸保持機構32の両方を操作することができる。例えば、操作部を動かしていない初期状態では、第1糸保持機構31が第1針部材21の先端と対向しているが、第1操作部51を構成するレバーを近位側に引くと、第1糸保持機構31が回転して第1針部材21よりも径方向の外側に配置される。さらに第1操作部51のレバーを近位側に引くと第1針部材21を遠位側に移動させることができる。第1操作部51のレバーを遠位側に戻すと、まず第1針部材21が近位側に戻り、その後、第1糸保持機構31が逆回転して第1針部材21の先端と対向する。第2操作部52についても同様に構成することができる。 It is preferable that the first operating portion 51 is also connected to the first thread holding mechanism 31 and the second operating portion 52 is also connected to the second thread holding mechanism 32 . Accordingly, by operating the first operating portion 51, both the first needle member 21 and the first thread holding mechanism 31 can be operated. Similarly, by operating the second operating portion 52, both the second needle member 22 and the second thread holding mechanism 32 can be operated. For example, in the initial state in which the operating section is not moved, the first thread holding mechanism 31 faces the tip of the first needle member 21. However, when the lever constituting the first operating section 51 is pulled proximally, The first thread holding mechanism 31 rotates and is arranged radially outside the first needle member 21 . Furthermore, when the lever of the first operating portion 51 is pulled proximally, the first needle member 21 can be moved distally. When the lever of the first operating portion 51 is returned to the distal side, the first needle member 21 is first returned to the proximal side, and then the first thread holding mechanism 31 rotates in the reverse direction to face the tip of the first needle member 21. do. The second operation section 52 can also be configured in the same manner.

図示していないが、装置1は、第1筒部材41を遠近方向xに移動させるための第3操作部と、第2筒部材42を遠近方向xに移動させるための第4操作部の少なくともいずれか一方を有していてもよい。装置1が第3操作部のみを持つ場合、第3操作部が第1糸保持機構31と第2糸保持機構32に接続されることが好ましい。これにより、第1筒部材41と第1糸保持機構31と第2糸保持機構32を1つの第3操作部で操作することができる。第4操作部のみを持つ場合、第4操作部が第1糸保持機構31と第2糸保持機構32に接続されていることが好ましい。これにより、第2筒部材42と第1糸保持機構31と第2糸保持機構32を1つの第4操作部で操作することができる。第3操作部と第4操作部の両方を持つ場合、第1糸保持機構31と第2糸保持機構32は、第3操作部と第4操作部のいずれかに接続される。なお、いずれの場合においても、針部材20と筒部材40の操作は別々に行うことが望ましいため、第1操作部51に第1筒部材41は接続されておらず、第2操作部52に第2筒部材42は接続されていないことが好ましい。 Although not shown, the device 1 includes at least a third operating section for moving the first cylindrical member 41 in the perspective direction x and a fourth operating section for moving the second cylindrical member 42 in the perspective direction x. You may have either one. If the device 1 only has a third operating part, the third operating part is preferably connected to the first thread holding mechanism 31 and the second thread holding mechanism 32 . Thereby, the first cylindrical member 41, the first thread holding mechanism 31, and the second thread holding mechanism 32 can be operated by one third operating portion. If only the fourth operating section is provided, it is preferable that the fourth operating section is connected to the first thread holding mechanism 31 and the second thread holding mechanism 32 . Thereby, the second cylindrical member 42, the first thread holding mechanism 31, and the second thread holding mechanism 32 can be operated by one fourth operating portion. When both the third operating section and the fourth operating section are provided, the first thread holding mechanism 31 and the second thread holding mechanism 32 are connected to either the third operating section or the fourth operating section. In either case, it is desirable to operate the needle member 20 and the tubular member 40 separately. Preferably, the second cylindrical member 42 is not connected.

第1操作部~第4操作部としては、種々の入力手段を用いることができ、例えば、トリガー(レバー)、スライダー、ダイヤル(ギアを含む回転体)、ボタン等とすることができる。また、モータや電子部品を用いて入力のオンオフ操作や入力量の調整を行ってもよく、操作部がロボットハンドで操作されてもよい。操作部が筐体10の外に設置されていてもよい。 Various input means can be used as the first to fourth operation sections, and for example, triggers (levers), sliders, dials (rotating bodies including gears), buttons and the like can be used. Also, the input ON/OFF operation and the input amount may be adjusted using a motor or an electronic component, and the operation unit may be operated by a robot hand. The operation unit may be installed outside the housing 10 .

第1操作部~第4操作部として同種類の入力手段を用いる場合、使用者が手元の感覚でどの操作部か容易に把握できることが好ましい。例えば、第1操作部51と第2操作部52がいずれもレバーである場合、第1操作部51と第2操作部52のレバーの長さを異ならせることができる。使用者の操作感覚と実際の装置における部材配置を一致させるために、第1操作部51は、第2操作部52よりも近位側に設けられることが好ましい。 When the same type of input means is used for the first to fourth operation sections, it is preferable that the user can easily grasp which operation section it is by feeling at hand. For example, when both the first operating portion 51 and the second operating portion 52 are levers, the lengths of the levers of the first operating portion 51 and the second operating portion 52 can be made different. It is preferable that the first operation portion 51 be provided closer to the proximal side than the second operation portion 52 in order to match the operational feeling of the user with the arrangement of members in the actual device.

2.医療用双方向縫合装置の作動方法
本発明の医療用双方向縫合装置1の作動方法を手順1-1として、図13~図29を参照しながら説明する。図13~図28は、本発明の医療用双方向縫合装置1の作動方法の各ステップの説明図を表し、各図面の(a)は、装置1の遠位側の内部の斜視図を表し、各図面の(b)は装置1の遠位側の断面図(一部側面図)を表している。図29は、本発明の医療用双方向縫合装置の作動方法を適用した縫合対象物70の説明図を表す。なお、装置1を構成する各部材については、本明細書の「1.医療用双方向縫合装置」に記載したとおりである。
2. Method of Operating the Bidirectional Medical Suturing Apparatus A method of operating the bidirectional medical suturing apparatus 1 of the present invention will be described as procedure 1-1 with reference to FIGS. 13 to 29. FIG. 13 to 28 are explanatory diagrams of each step of the operation method of the two-way medical suturing device 1 of the present invention, and (a) of each drawing is a perspective view of the interior of the device 1 on the distal side. , (b) of each drawing represents a cross-sectional view (partial side view) of the distal side of the device 1 . FIG. 29 is an explanatory diagram of a suturing object 70 to which the method for operating a two-way medical suturing device of the present invention is applied. Each member constituting the device 1 is as described in "1. Medical two-way suturing device" in this specification.

(1)装置の準備
遠近方向に延在している筐体10と、筐体10に配置されている第1針部材21と第2針部材22と、第1針部材21よりも遠位側に配置されている第1糸保持機構31と、第2針部材22の先端22Aと第1糸保持機構31の遠位端の間に配置されている第2糸保持機構32と、を有しており、第1針部材21は、第2針部材22よりも近位側に配置されており、第1針部材21と第2針部材22は、それぞれ遠近方向に延在しており、第1針部材21は、先端21Aが遠位側を向いており、第2針部材22は、先端22Aが近位側を向いている医療用双方向縫合装置1と、糸60を準備する(ステップS1)。
(1) Preparation of the Apparatus The housing 10 extending in the far-near direction, the first needle member 21 and the second needle member 22 arranged in the housing 10, and the distal side of the first needle member 21 and a second thread retaining mechanism 32 disposed between the tip 22A of the second needle member 22 and the distal end of the first thread retaining mechanism 31. , the first needle member 21 is arranged on the proximal side of the second needle member 22, the first needle member 21 and the second needle member 22 each extend in the far-near direction, and the first needle member 21 extends in the near-field direction. The tip 21A of the first needle member 21 faces distally, and the tip 22A of the second needle member 22 faces the proximal side. S1).

(2)近位側から遠位側への縫合
図13に示すように、第1糸保持機構31で糸60を保持する(ステップS2)。このとき、第2糸保持機構32が第1糸保持機構31と連動してもよい。
(2) Suturing from the Proximal Side to the Distal Side As shown in FIG. 13, the thread 60 is held by the first thread holding mechanism 31 (step S2). At this time, the second thread holding mechanism 32 may be interlocked with the first thread holding mechanism 31 .

図13に示すように、第1針部材21と第2針部材22の間に縫合対象物70を配置する(ステップS3)。詳細には、第1糸保持機構31と第2糸保持機構32の間に縫合対象物70を配置することが好ましい。 As shown in FIG. 13, the object to be sutured 70 is arranged between the first needle member 21 and the second needle member 22 (step S3). Specifically, it is preferable to place the suture object 70 between the first thread holding mechanism 31 and the second thread holding mechanism 32 .

図14に示すように、遠近方向xから見て、第1糸保持機構31が第1針部材21よりも半径方向の外側に位置するように第1糸保持機構31を動かす(ステップS4)。このとき、第2糸保持機構32が第1糸保持機構31と連動してもよい。 As shown in FIG. 14, the first thread holding mechanism 31 is moved so that the first thread holding mechanism 31 is located radially outside the first needle member 21 when viewed in the perspective direction x (step S4). At this time, the second thread holding mechanism 32 may be interlocked with the first thread holding mechanism 31 .

図15に示すように、第1筒部材41を遠位側に移動させることが好ましい(ステップS5)。ステップS5に代えて、第2筒部材42を近位側に移動させてもよく、第1筒部材41を遠位側に移動させ、かつ第2筒部材42を近位側に移動させてもよい。このとき、第1筒部材41と第2筒部材42で縫合対象物70を挟んで固定することが好ましい。第1筒部材41と第2筒部材42によって縫合対象物70に張力が付与されるため、第1針部材21を穿刺しやすくなる。 As shown in FIG. 15, it is preferable to move the first tubular member 41 distally (step S5). Instead of step S5, the second cylindrical member 42 may be moved proximally, or the first cylindrical member 41 may be moved distally and the second cylindrical member 42 may be moved proximally. good. At this time, it is preferable that the object to be sewn 70 is sandwiched between the first tubular member 41 and the second tubular member 42 and fixed. Since tension is applied to the object to be sutured 70 by the first cylindrical member 41 and the second cylindrical member 42, the first needle member 21 can be easily punctured.

図16に示すように、第1針部材21を遠位側に移動させる(ステップS6)。詳細には、第1針部材21を遠位側に移動させ、糸60の一部を縫合対象物70よりも遠位側に移動させる。このとき、第1針部材21の先端21Aが縫合対象物70よりも遠位側に位置するように第1針部材21を移動させることが好ましい。これにより、第1針部材21の先端部に糸60が掛けられた後、縫合対象物70に第1針部材21が穿刺され、糸60の折り返し部61を縫合対象物70よりも遠位側に配置することができる。後の工程で第2糸保持機構32が糸60を保持しやすくするために、糸60の折り返し部61が、第2筒部材42の内腔に配置されることが好ましい。 As shown in FIG. 16, the first needle member 21 is moved distally (step S6). Specifically, the first needle member 21 is moved distally, and a portion of the thread 60 is moved distally of the sutured object 70 . At this time, it is preferable to move the first needle member 21 so that the tip 21A of the first needle member 21 is located on the distal side of the sutured object 70 . As a result, after the thread 60 is hooked on the tip of the first needle member 21 , the first needle member 21 is pierced through the sutured object 70 , and the folded portion 61 of the thread 60 is pushed to the distal side of the sutured object 70 . can be placed in Preferably, the folded portion 61 of the thread 60 is arranged in the inner cavity of the second cylindrical member 42 so that the second thread holding mechanism 32 can easily hold the thread 60 in a later step.

図17に示すように、第1針部材21を近位側に移動させる(ステップS7)。このとき、第1針部材21の先端が縫合対象物70よりも近位側に位置するように第1針部材21を移動させることが好ましい。これにより、縫合対象物70から第1針部材21を抜くことができ、糸60のみが縫合対象物70を貫通した状態になる。 As shown in FIG. 17, the first needle member 21 is moved proximally (step S7). At this time, it is preferable to move the first needle member 21 so that the tip of the first needle member 21 is located on the proximal side of the suture object 70 . As a result, the first needle member 21 can be pulled out from the object 70 to be sutured, and only the thread 60 penetrates the object 70 to be sutured.

ステップS5を行っていた場合、第1筒部材41と第2筒部材42の少なくともいずれか一方を元の位置に戻す(ステップS8)。例えば、ステップS5で第1筒部材41を遠位側に移動させていた場合には、図18に示すように第1筒部材41を近位側に移動させる。 If step S5 has been performed, at least one of the first cylindrical member 41 and the second cylindrical member 42 is returned to its original position (step S8). For example, if the first cylindrical member 41 was moved distally in step S5, the first cylindrical member 41 is moved proximally as shown in FIG.

図19に示すように、第2糸保持機構32で糸60を保持する(ステップS9)。第2糸保持機構32によって縫合対象物70よりも遠位側で糸60が保持されるため、装置1を移動させても縫合対象物70から糸60が抜けることを防ぐことができる。近位側から遠位側への縫合は以上で完了する。ここで、作業を終える場合は、図19に示すように第2糸保持機構32で糸60を保持したまま装置1を近位側に移動させることで、糸60の一方端を回収することができる。 As shown in FIG. 19, the yarn 60 is held by the second yarn holding mechanism 32 (step S9). Since the second thread holding mechanism 32 holds the thread 60 on the distal side of the sutured object 70, it is possible to prevent the thread 60 from coming off the sutured object 70 even when the apparatus 1 is moved. The suturing from the proximal side to the distal side is now complete. Here, when finishing the work, one end of the thread 60 can be recovered by moving the device 1 to the proximal side while the thread 60 is held by the second thread holding mechanism 32 as shown in FIG. can.

(3)遠位側から近位側への縫合
上記(2)項で説明した縫合位置とは別の位置に第2針部材22が配置されるように装置1を移動させる(ステップS10)。例えば、図20に示すように筐体10の凹部11を縫合位置から離し、縫合位置を図21(a)の左側から右側に移動させるために図21に示すように装置1全体を回転させる。
(3) Suturing from the Distal Side to the Proximal Side The device 1 is moved so that the second needle member 22 is arranged at a position different from the suturing position described in (2) above (step S10). For example, as shown in FIG. 20, the concave portion 11 of the housing 10 is moved away from the stitching position, and the entire device 1 is rotated as shown in FIG. 21 to move the stitching position from the left side to the right side in FIG.

装置1を回転させた後のステップは、以下の2種類に分けられる。
(a)図21に示すように、第2糸保持機構32が糸60を保持しているときには、以下のステップS11以降を実施する。
(b)第2糸保持機構32が糸60を保持していないときには、以下のステップS12以降を実施する。
The steps after rotating the device 1 are divided into the following two types.
(a) As shown in FIG. 21, when the second thread holding mechanism 32 is holding the thread 60, the following step S11 and subsequent steps are performed.
(b) When the second thread holding mechanism 32 does not hold the thread 60, the following step S12 and subsequent steps are performed.

図22に示すように、遠近方向xから見て、第2糸保持機構32が第2針部材22よりも半径方向の外側に位置するように第2糸保持機構32を動かす(ステップS11)。このとき、第1糸保持機構31が第2糸保持機構32と連動してもよい。 As shown in FIG. 22, the second thread holding mechanism 32 is moved so that the second thread holding mechanism 32 is positioned radially outside the second needle member 22 when viewed in the perspective direction x (step S11). At this time, the first thread holding mechanism 31 may be interlocked with the second thread holding mechanism 32 .

図23に示すように、第1筒部材41を遠位側に移動させることが好ましい(ステップS12)。ステップS12に代えて、第2筒部材42を近位側に移動させてもよく、第1筒部材41を遠位側に移動させ、かつ第2筒部材42を近位側に移動させてもよい。このとき、第1筒部材41と第2筒部材42で縫合対象物70を挟んで固定することが好ましい。第1筒部材41と第2筒部材42によって縫合対象物70に張力が付与されるため、第2針部材22を穿刺しやすくなる。 As shown in FIG. 23, it is preferable to move the first cylindrical member 41 distally (step S12). Instead of step S12, the second cylindrical member 42 may be moved proximally, or the first cylindrical member 41 may be moved distally and the second cylindrical member 42 may be moved proximally. good. At this time, it is preferable that the object to be sewn 70 is sandwiched between the first tubular member 41 and the second tubular member 42 and fixed. Since tension is applied to the object to be sutured 70 by the first cylindrical member 41 and the second cylindrical member 42, the second needle member 22 can be easily punctured.

図24に示すように、第2針部材22を近位側に移動させる(ステップS13)。詳細には、第2針部材22を近位側に移動させ、糸60の一部を縫合対象物70よりも近位側に配置する。このとき、第2針部材22の先端22Aが縫合対象物70よりも近位側に位置するように第2針部材22を移動させることが好ましい。これにより、第2針部材22の先端部に糸60が掛けられた後、縫合対象物70に第2針部材22が穿刺され、糸60の折り返し部61を縫合対象物70よりも近位側に配置することができる。後の工程で第2糸保持機構32が糸60を保持しやすくするために、糸60の折り返し部61が、第1筒部材41の内腔に配置されることが好ましい。 As shown in FIG. 24, the second needle member 22 is moved proximally (step S13). Specifically, the second needle member 22 is moved proximally, and a portion of the thread 60 is arranged proximally of the object 70 to be sutured. At this time, it is preferable to move the second needle member 22 so that the distal end 22A of the second needle member 22 is positioned closer to the sutured object 70 on the proximal side. As a result, after the thread 60 is hooked on the distal end of the second needle member 22 , the second needle member 22 is pierced through the sutured object 70 , and the folded portion 61 of the thread 60 is pushed closer to the proximal side than the sutured object 70 . can be placed in It is preferable that the folded portion 61 of the thread 60 is arranged in the inner cavity of the first tubular member 41 so that the second thread holding mechanism 32 can easily hold the thread 60 in a later step.

図25に示すように、第2針部材22を遠位側に移動させる(ステップS14)。このとき、第2針部材22の先端22Aが縫合対象物70よりも遠位側に位置するように第2針部材22を移動させることが好ましい。これにより、縫合対象物70から第2針部材22を抜くことができ、糸60のみが縫合対象物70を貫通した状態になる。 As shown in FIG. 25, the second needle member 22 is moved distally (step S14). At this time, it is preferable to move the second needle member 22 so that the tip 22A of the second needle member 22 is located on the distal side of the sutured object 70 . As a result, the second needle member 22 can be pulled out from the object 70 to be sutured, and only the thread 60 penetrates the object 70 to be sutured.

ステップS12を行っていた場合、第1筒部材41と第2筒部材42の少なくともいずれか一方を元の位置に戻す(ステップS15)。例えば、ステップS12で第1筒部材41を遠位側に移動させていた場合には、図26に示すように第1筒部材41を近位側に移動させる。 If step S12 has been performed, at least one of the first cylindrical member 41 and the second cylindrical member 42 is returned to its original position (step S15). For example, if the first cylindrical member 41 was moved distally in step S12, the first cylindrical member 41 is moved proximally as shown in FIG.

図27に示すように、第1糸保持機構31で糸60を保持する(ステップS16)。第1糸保持機構31によって縫合対象物70よりも近位側で糸60が保持されるため、装置1を移動させても縫合対象物70から糸60が抜けることを防ぐことができる。遠位側から近位側への縫合は以上で完了する。 As shown in FIG. 27, the thread 60 is held by the first thread holding mechanism 31 (step S16). Since the first thread holding mechanism 31 holds the thread 60 on the proximal side of the suture object 70 , it is possible to prevent the thread 60 from slipping out of the suture object 70 even when the apparatus 1 is moved. The suturing from the distal side to the proximal side is now complete.

図28に示すように、装置1を近位側に移動させて糸60の自由端を引き出す(ステップS17)。 As shown in FIG. 28, the device 1 is moved proximally to pull out the free end of the thread 60 (step S17).

次いで、縫合を続ける場合には、第1糸保持機構31が糸60を保持したまま、ステップS3から行うことができる。次に縫合する対象物は、これまでのステップで説明した縫合対象物でもよく、図示していない別の縫合対象物でもよい。縫合対象物は、縫合の目的、切創部の大きさや形などから総合的に術者によって決定される。縫合を完了する場合には、例えば図29に示すように、縫合対象物の近位側に露出している糸60の一方側と他方側を引っ張り、縫合対象物同士を引き寄せてノット(結び目)を作製する。 Next, when suturing is to be continued, the process can be performed from step S3 while the first thread holding mechanism 31 is holding the thread 60 . The object to be sewn next may be the object to be sewn described in the previous steps or another object to be sewn (not shown). The object to be sutured is comprehensively determined by the operator based on the purpose of suturing, the size and shape of the incision, and the like. When suturing is completed, for example, as shown in FIG. 29, one side and the other side of the thread 60 exposed on the proximal side of the object to be sutured are pulled, the objects to be sutured are pulled together, and a knot is tied. to make.

次に、図30~図41を参照しながら、本発明の医療用双方向縫合装置の他の作動方法を手順1-2として説明する。具体的には、第1糸保持機構31が遠近方向xに沿って移動可能な装置の作動方法について説明する。図30~図41は、装置1の他の作動方法の各ステップの説明図を表し、各図面の(a)は、装置1の遠位側の内部の斜視図を表し、各図面の(b)は装置1の遠位側の断面図(一部側面図)を表している。 Next, referring to FIGS. 30 to 41, another operation method of the medical suturing device of the present invention will be described as procedure 1-2. Specifically, a method of operating a device in which the first thread holding mechanism 31 can move along the perspective direction x will be described. 30 to 41 represent explanatory views of each step of another operation method of the device 1, (a) of each drawing represents a perspective view of the interior of the distal side of the device 1, and (b) of each drawing ) shows a cross-sectional view (partial side view) of the distal side of the device 1. FIG.

(1)装置の準備
遠近方向xに延在している筐体10と、筐体10に設けられている第1針部材21と第2針部材22と、第1針部材21よりも遠位側に配置されている第1糸保持機構31と、第2針部材22の先端22Aと第1糸保持機構31の遠位端の間に配置されている第2糸保持機構32と、を有しており、第1針部材21は、第2針部材22よりも近位側に配置されており、第1針部材21と第2針部材22は、それぞれ遠近方向に延在しており、第1針部材21は、先端21Aが遠位側を向いており、第2針部材22は、先端22Aが近位側を向いており、第1糸保持機構31と第1筒部材41が遠近方向xに移動可能であり、第2糸保持機構32と第2筒部材42が遠近方向xに移動可能である医療用双方向縫合装置1と、糸60を準備する(ステップS101)。
(1) Preparation of the Apparatus A housing 10 extending in the far-near direction x, a first needle member 21 and a second needle member 22 provided on the housing 10, and a device distal to the first needle member 21 and a second thread retaining mechanism 32 disposed between the tip 22A of the second needle member 22 and the distal end of the first thread retaining mechanism 31. , the first needle member 21 is arranged on the proximal side of the second needle member 22, the first needle member 21 and the second needle member 22 each extend in the distance direction, The tip 21A of the first needle member 21 faces the distal side, and the tip 22A of the second needle member 22 faces the proximal side. The two-way medical suturing device 1, which is movable in the direction x and the second thread holding mechanism 32 and the second cylindrical member 42 are movable in the direction x, and the thread 60 are prepared (step S101).

(2)近位側から遠位側への縫合
ステップS2と同様に、第1糸保持機構31で糸60を保持する(ステップS102)。
(2) Suturing from the Proximal Side to the Distal Side As in step S2, the thread 60 is held by the first thread holding mechanism 31 (step S102).

ステップS3と同様に、第1針部材21と第2針部材22の間に縫合対象物70を配置する(ステップS103)。 As in step S3, the object to be sutured 70 is arranged between the first needle member 21 and the second needle member 22 (step S103).

図30に示すように、第1糸保持機構31で糸60を保持した状態で、第1筒部材41と第1糸保持機構31を遠位側に移動させる(ステップS104)。このとき、第1筒部材41と第2筒部材42で縫合対象物70を挟んで固定することが好ましい。第1筒部材41と第2筒部材42によって縫合対象物70に張力が付与されるため、第1針部材21を穿刺しやすくなる。ステップS104に代えて、第1糸保持機構31で糸60を保持した状態で、第2筒部材42と第2糸保持機構32を近位側に移動させてもよく、第1筒部材41と第1糸保持機構31を遠位側に移動させ、かつ第2筒部材42と第2糸保持機構32を近位側に移動させてもよい。 As shown in FIG. 30, the first cylindrical member 41 and the first thread holding mechanism 31 are moved distally while the thread 60 is held by the first thread holding mechanism 31 (step S104). At this time, it is preferable that the object to be sewn 70 is sandwiched between the first tubular member 41 and the second tubular member 42 and fixed. Since tension is applied to the object to be sutured 70 by the first cylindrical member 41 and the second cylindrical member 42, the first needle member 21 can be easily punctured. Instead of step S104, while the thread 60 is held by the first thread holding mechanism 31, the second tubular member 42 and the second thread holding mechanism 32 may be moved proximally. The first thread holding mechanism 31 may be moved distally, and the second tubular member 42 and the second thread holding mechanism 32 may be moved proximally.

ステップS4と同様にして、図31に示すように遠近方向xから見て、第1糸保持機構31が第1針部材21よりも半径方向の外側に位置するように第1糸保持機構31を動かす(ステップS105)。 As in step S4, the first thread holding mechanism 31 is positioned radially outside the first needle member 21 when viewed in the perspective direction x as shown in FIG. Move (step S105).

ステップS6と同様にして、図32に示すように第1針部材21を遠位側に移動させる(ステップS106)。 As in step S6, the first needle member 21 is moved distally as shown in FIG. 32 (step S106).

ステップS7と同様にして、図33に示すように第1針部材21を近位側に移動させる(ステップS107)。 As in step S7, the first needle member 21 is moved proximally as shown in FIG. 33 (step S107).

ステップS9と同様にして、図34に示すように第2糸保持機構32で糸60を保持する(ステップS108)。 As in step S9, the thread 60 is held by the second thread holding mechanism 32 as shown in FIG. 34 (step S108).

図35に示すように、第1筒部材41と第1糸保持機構31を近位側に移動させる(ステップS109)。近位側から遠位側への縫合は以上で完了する。ここで作業を終える場合には、第2糸保持機構32で糸60を保持したまま装置1を近位側に移動させることで、糸60の一方端を回収することができる。 As shown in FIG. 35, the first cylindrical member 41 and the first thread holding mechanism 31 are moved proximally (step S109). The suturing from the proximal side to the distal side is now complete. When finishing the work here, one end of the thread 60 can be recovered by moving the device 1 to the proximal side while the thread 60 is held by the second thread holding mechanism 32 .

(3)遠位側から近位側への縫合
ステップS10と同様にして、上記(2)項で説明した縫合位置とは別の位置に第2針部材22が配置されるように装置1を移動させる(ステップS110)。
(3) Suturing from the Distal Side to the Proximal Side Similar to step S10, the device 1 is arranged so that the second needle member 22 is placed at a position different from the suturing position described in (2) above. Move (step S110).

図36に示すように、第2糸保持機構32で糸60を保持した状態で、第1筒部材41と第1糸保持機構31を遠位側に移動させる(ステップS111)。このとき、第2針部材22を穿刺しやすくするために、第1筒部材41と第2筒部材42で縫合対象物70を挟んで固定することが好ましい。ステップS110に代えて、第1糸保持機構31で糸60を保持した状態で、第2筒部材42と第2糸保持機構32を近位側に移動させてもよく、第1筒部材41と第1糸保持機構31を遠位側に移動させ、かつ第2筒部材42と第2糸保持機構32を近位側に移動させてもよい。 As shown in FIG. 36, while the thread 60 is held by the second thread holding mechanism 32, the first tubular member 41 and the first thread holding mechanism 31 are moved distally (step S111). At this time, it is preferable to sandwich and fix the object 70 to be sutured between the first cylindrical member 41 and the second cylindrical member 42 in order to make it easier to puncture the second needle member 22 . Instead of step S110, while the thread 60 is held by the first thread holding mechanism 31, the second tubular member 42 and the second thread holding mechanism 32 may be moved proximally. The first thread holding mechanism 31 may be moved distally, and the second tubular member 42 and the second thread holding mechanism 32 may be moved proximally.

ステップS11と同様にして、図37に示すように、遠近方向xから見て、第2糸保持機構32が第2針部材22よりも半径方向の外側に位置するように第2糸保持機構32を動かす(ステップS112)。 As in step S11, as shown in FIG. 37, the second thread holding mechanism 32 is positioned outside the second needle member 22 in the radial direction when viewed in the perspective direction x. is moved (step S112).

ステップS13と同様にして、図38に示すように第2針部材22を近位側に移動させる(ステップS113)。 As in step S13, the second needle member 22 is moved proximally as shown in FIG. 38 (step S113).

ステップS14と同様にして、図39に示すように第2針部材22を遠位側に移動させる(ステップS114)。 As in step S14, the second needle member 22 is moved distally as shown in FIG. 39 (step S114).

ステップS16と同様にして、図40に示すように、第1糸保持機構31で糸60を保持する(ステップS115)。 As in step S16, as shown in FIG. 40, the first thread holding mechanism 31 holds the thread 60 (step S115).

図41に示すように、第1糸保持機構31で糸60を保持した状態で、第1筒部材41と第1糸保持機構31を近位側に移動させる(ステップS116)。 As shown in FIG. 41, while the thread 60 is held by the first thread holding mechanism 31, the first tubular member 41 and the first thread holding mechanism 31 are moved proximally (step S116).

ステップS17と同様にして、装置1を近位側に移動させて糸60の自由端を引き出す(ステップS117)。 Similar to step S17, the device 1 is moved proximally to pull out the free end of the thread 60 (step S117).

次いで縫合を続ける場合には、ステップS103に戻る。 Then, if suturing is to be continued, the process returns to step S103.

縫合装置1の使用時に、糸60を保持している側の針部材20を動かす前に、もう一方の針部材20であらかじめ縫合対象物70に穴を開けておいてもよい。これにより、糸60をスムーズに移動させることができる。したがって、第1針部材21または第2針部材22のいずれか一方を移動させて、糸60の一部を縫合対象物70よりも近位側または遠位側に移動させるステップの前に、第1針部材21または第2針部材22のいずれか他方を、縫合対象物70よりも遠位側または近位側に移動させるステップと、第1針部材21と第2針部材22のいずれか他方を、縫合対象物70よりも近位側または遠位側に移動させるステップとを含むことが好ましい。 When using the suturing device 1 , before moving the needle member 20 holding the thread 60 , the other needle member 20 may be used to pierce the suture object 70 in advance. Thereby, the thread 60 can be moved smoothly. Therefore, before the step of moving either the first needle member 21 or the second needle member 22 to move a portion of the thread 60 to the proximal side or the distal side of the suture object 70, the second needle member 21 or the second needle member 22 is moved. a step of moving the other of the first needle member 21 and the second needle member 22 to the distal side or the proximal side of the suture target 70; is moved proximally or distally relative to the suture object 70 .

詳細には、手順1-1、手順1-2の「(2)近位側から遠位側への縫合」において、第1針部材21を遠位側に移動させて、糸60の一部を縫合対象物70よりも遠位側に移動させるステップS6またはステップS106の前に、第2針部材22を縫合対象物70よりも遠位側に移動させて(ステップS120)、第2針部材22を縫合対象物70よりも近位側に移動させてもよい(ステップS121)。あるいは、手順1-1、手順1-2の「(3)遠位側から近位側への縫合」において、第2針部材22を近位側に移動させて、糸60の一部を縫合対象物70よりも近位側に移動させるステップS13またはステップS113の前に、第1針部材21を縫合対象物70よりも近位側に移動させて(ステップS122)、第1針部材21を縫合対象物70よりも遠位側に移動させてもよい(ステップS123)。 Specifically, in “(2) Suturing from the proximal side to the distal side” of Procedures 1-1 and 1-2, the first needle member 21 is moved distally, and part of the thread 60 is to the distal side of the suture object 70, the second needle member 22 is moved to the distal side of the suture object 70 (step S120), and the second needle member 22 may be moved to the proximal side relative to the suture object 70 (step S121). Alternatively, in "(3) Suturing from the distal side to the proximal side" of Procedures 1-1 and 1-2, the second needle member 22 is moved proximally to suture part of the thread 60. Before step S13 or step S113 of moving the object 70 to the proximal side, the first needle member 21 is moved to the proximal side of the suture object 70 (step S122), and the first needle member 21 is moved to the proximal side. It may be moved to the distal side from the suture object 70 (step S123).

上記ではTSSでの硬膜の縫合を例に挙げて説明したが、これに限定されず、手術の種類や縫合対象物(すなわち、生体組織の種類)は適宜選択できる。本発明の縫合装置1は、開頭手術・開腹手術・開胸手術といったあらゆる手術において、内視鏡や顕微鏡の使用の有無に限定されずに使用できる。さらに、本発明は、操作部を医師等が直接操作する例を用いて説明したが、これに限定されずマニピュレータを有するロボットを用いて操作できる。上記生体組織としては、例えば、硬膜・くも膜・胸膜・心膜・腹膜等の膜組織のみに限定されず、皮膚・血管・肺・心臓・消化管・骨・筋等のあらゆる生体組織を含むことができる。 Although suturing the dura mater in TSS has been described above as an example, the present invention is not limited to this, and the type of surgery and the sutured object (that is, the type of living tissue) can be selected as appropriate. The suturing device 1 of the present invention can be used in all surgeries such as craniotomy, laparotomy, and thoracotomy, regardless of whether or not an endoscope or microscope is used. Furthermore, although the present invention has been described using an example in which a doctor or the like directly operates the operating section, the present invention is not limited to this and can be operated using a robot having a manipulator. The biological tissue is not limited to membranous tissue such as dura mater, arachnoid membrane, pleura, pericardium, peritoneum, etc., but includes all biological tissues such as skin, blood vessels, lungs, heart, gastrointestinal tract, bone, muscle, etc. be able to.

本願は、2018年2月20日に出願された日本国特許出願第2018-28154号に基づく優先権の利益を主張するものである。2018年2月20日に出願された日本国特許出願第2018-28154号の明細書の全内容が、本願に参考のため援用される。 This application claims the benefit of priority based on Japanese Patent Application No. 2018-28154 filed on February 20, 2018. The entire contents of the specification of Japanese Patent Application No. 2018-28154 filed on February 20, 2018 are incorporated herein by reference.

1:医療用双方向縫合装置
10:筐体
11:凹部
20:針部材
21:第1針部材
21A:先端
21B:第1端部
21C:第2端部
22:第2針部材
22A:先端
22B:第1端部
22C:第2端部
23:穿刺部
24:貫通孔
30:糸保持機構
31:第1糸保持機構
32:第2糸保持機構
33:回転軸
34:固定部
35:糸当接部
36:接続部材
37:棒状部材
38:挟持部材
38A:挿通路
38B:切り欠き
39:支持部材
40:筒部材
41:第1筒部材
41A:第1開口
42:第2筒部材
42A:第2開口
50:ハンドル
51:第1操作部
52:第2操作部
60:糸
61:糸の折り返し部
70:縫合対象物
1: Medical two-way suture device 10: Housing 11: Recess 20: Needle member 21: First needle member 21A: Tip 21B: First end 21C: Second end 22: Second needle member 22A: Tip 22B : First end portion 22C: Second end portion 23: Puncture portion 24: Through hole 30: Thread holding mechanism 31: First thread holding mechanism 32: Second thread holding mechanism 33: Rotating shaft 34: Fixed portion 35: Thread abutment Contact portion 36: Connecting member 37: Rod member 38: Clamping member 38A: Insertion path 38B: Notch 39: Supporting member 40: Cylinder member 41: First cylindrical member 41A: First opening 42: Second cylindrical member 42A: Third 2 opening 50: handle 51: first operation part 52: second operation part 60: thread 61: thread folding part 70: object to be sutured

Claims (17)

縫合対象物を糸で縫合可能な医療用双方向縫合装置であって、
遠近方向に延在している筐体と、
前記筐体に設けられている第1針部材と第2針部材と、を有しており、
前記第1針部材は、前記第2針部材よりも近位側に配置されており、
前記第1針部材と前記第2針部材は、それぞれ遠近方向に延在しており、
前記第1針部材の先端が遠位側を向き、前記第2針部材の先端が近位側を向いた状態で、前記第1針部材の先端よりも遠位側に前記第2針部材の先端が配されており、
前記第1針部材と前記第2針部材の間に前記縫合対象物が配置され、
前記第1針部材が遠位側に移動することで前記糸の一部が前記縫合対象物よりも遠位側に移動し、
前記第2針部材が近位側に移動することで前記糸の一部が前記縫合対象物よりも近位側に移動する医療用双方向縫合装置。
A two-way medical suturing device capable of suturing an object to be sutured with thread,
a housing extending in the near and far directions;
a first needle member and a second needle member provided on the housing;
the first needle member is arranged on the proximal side of the second needle member,
the first needle member and the second needle member each extend in a distance direction,
With the tip of the first needle member facing distally and the tip of the second needle member facing proximally, the tip of the second needle member is positioned distally of the tip of the first needle member. The tip is arranged,
the object to be sutured is arranged between the first needle member and the second needle member;
movement of the first needle member distally causes a portion of the thread to move distally from the object to be sutured;
A two-way suturing device for medical use, wherein movement of the second needle member to the proximal side moves a portion of the thread to the proximal side relative to the object to be sutured.
前記第1針部材と前記第2針部材は、前記遠近方向に沿って移動可能である請求項1に記載の装置。 2. The device of claim 1, wherein the first needle member and the second needle member are movable along the distance direction. 遠近方向から見て、前記第1針部材と前記第2針部材が互いに重なっている請求項1または2に記載の装置。 3. A device according to claim 1 or 2, wherein said first needle member and said second needle member overlap each other when viewed in perspective. 前記第1針部材または前記第2針部材の先端が、少なくとも第1端部と第2端部の二又に分かれている請求項1~3のいずれか一項に記載の装置。 A device according to any one of claims 1 to 3, wherein the tip of said first needle member or said second needle member is bifurcated into at least a first end and a second end. 前記筐体は、前記第1針部材と前記第2針部材との間における前記遠近方向と垂直な断面において、前記医療用双方向縫合装置の重心から前記第1針部材の中心軸に向かう上方向と、前記中心軸から前記重心に向かう下方向を有しており、
前記第1端部と前記第2端部が上下方向に離間している請求項4に記載の装置。
In a cross section perpendicular to the perspective direction between the first needle member and the second needle member, the housing extends upward from the center of gravity of the two-way medical suturing device toward the central axis of the first needle member. and a downward direction from the central axis toward the center of gravity;
5. The device of claim 4, wherein said first end and said second end are vertically spaced apart.
さらに、前記第1針部材よりも遠位側に配置されている第1糸保持機構と、
前記第2針部材の先端と前記第1糸保持機構の遠位端の間に配置されている第2糸保持機構と、を有しており、
前記第1糸保持機構と前記第2糸保持機構は糸の保持および糸の保持解除を行うものである請求項1~5のいずれか一項に記載の装置。
a first thread holding mechanism disposed distally of the first needle member;
a second thread retention mechanism positioned between the tip of the second needle member and the distal end of the first thread retention mechanism;
The device according to any one of claims 1 to 5, wherein the first thread holding mechanism and the second thread holding mechanism are for holding and releasing the thread.
前記第1針部材の遠位端よりも近位側に配置されている第1糸保持機構と、前記第2針部材の先端と前記第1糸保持機構の遠位端の間に配置されている第2糸保持機構と、前記第1糸保持機構に接続されており、前記第1糸保持機構の少なくとも一部を前記第1針部材の遠位端よりも遠位側に移動させる移動機構とを含み、前記第1糸保持機構と前記第2糸保持機構は糸の保持および糸の保持解除を行うものである請求項1~5のいずれか一項に記載の装置。 a first thread holding mechanism located proximal to the distal end of the first needle member; and a thread holding mechanism located between the tip of the second needle member and the distal end of the first thread holding mechanism. and a moving mechanism connected to the first thread holding mechanism and configured to move at least a portion of the first thread holding mechanism distally of the distal end of the first needle member. 6. The apparatus according to any one of claims 1 to 5, wherein said first thread holding mechanism and said second thread holding mechanism are for holding and releasing a thread. 前記筐体は、前記第1針部材と前記第2針部材との間における前記遠近方向と垂直な断面において、前記医療用双方向縫合装置の重心から前記第1針部材の中心軸に向かう上方向と、前記中心軸から前記重心に向かう下方向を有しており、
前記第1糸保持機構または前記第2糸保持機構は、上下方向以外の第1方向を軸として回転する請求項6または7に記載の装置。
In a cross section perpendicular to the perspective direction between the first needle member and the second needle member, the housing extends upward from the center of gravity of the two-way medical suturing device toward the central axis of the first needle member. and a downward direction from the central axis toward the center of gravity;
The device according to claim 6 or 7, wherein the first thread holding mechanism or the second thread holding mechanism rotates about a first direction other than the vertical direction.
前記第1方向が、前記遠近方向または、前記上下方向および前記遠近方向の両方に垂直な方向である請求項8に記載の装置。 9. The apparatus of claim 8, wherein the first direction is the perspective direction or a direction perpendicular to both the up-down direction and the perspective direction. 前記医療用双方向縫合装置は、近位側に操作部を有し、
前記第1糸保持機構は、前記第1方向を軸とする回転軸と、
前記回転軸を挟んだ一方側に設けられており、前記操作部に直接または間接的に固定されている固定部と、
前記回転軸を挟んだ他方側に設けられており、糸が当接する糸当接部と、を有する請求項8または9に記載の装置。
The bidirectional suturing device for medical use has an operation part on the proximal side,
The first thread holding mechanism includes a rotating shaft having the first direction as an axis;
a fixed portion provided on one side of the rotating shaft and directly or indirectly fixed to the operation portion;
10. The device according to claim 8 or 9, further comprising: a thread abutting portion provided on the other side of the rotating shaft and against which the thread abuts.
前記第1糸保持機構または前記第2糸保持機構は、前記第1針部材または前記第2針部材の軸中心に向かって突出可能である請求項6または7に記載の装置。 8. A device according to claim 6 or 7, wherein said first thread holding mechanism or said second thread holding mechanism is protrusible towards the axial center of said first needle member or said second needle member. 前記第1糸保持機構と前記第2糸保持機構の少なくともいずれか一方が、前記遠近方向に沿って移動可能である請求項6または7に記載の装置。 8. A device according to claim 6 or 7, wherein at least one of the first thread holding mechanism and the second thread holding mechanism is movable along the perspective direction. さらに、前記第1針部材を内包する第1筒部材と、前記第2針部材を内包する第2筒部材が設けられており、前記第1筒部材と前記第2筒部材の少なくともいずれか一方が、前記遠近方向に沿って、前記筐体に対して移動可能である請求項1~12のいずれか一項に記載の装置。 Further, a first tubular member enclosing the first needle member and a second tubular member enclosing the second needle member are provided, and at least one of the first tubular member and the second tubular member is provided. is movable relative to the housing along the perspective direction. さらに、前記第1針部材を内包する第1筒部材と、前記第2針部材を内包する第2筒部材が設けられており、前記第1糸保持機構が前記第1筒部材に設けられている構成と、前記第2糸保持機構が前記第2筒部材に設けられている構成の少なくともいずれか一方の構成を有している請求項6~12のいずれか一項に記載の装置。 Further, a first tubular member enclosing the first needle member and a second tubular member enclosing the second needle member are provided, and the first thread holding mechanism is provided in the first tubular member. 13. The device according to any one of claims 6 to 12, having at least one of a configuration in which the second thread holding mechanism is provided in the second tubular member. 前記第1筒部材の遠位端面と前記第2筒部材の近位端面が向かい合っている請求項13または14に記載の装置。 15. Apparatus according to claim 13 or 14, wherein the distal end face of said first tubular member and the proximal end face of said second tubular member face each other. 遠近方向に延在している筐体と、前記筐体に設けられている第1針部材と第2針部材と、前記第1針部材を内包し前記遠近方向に沿って移動可能な第1筒部材と、前記第2針部材を内包し前記遠近方向に沿って移動可能な第2筒部材と、を有しており、前記第1針部材は、前記第2針部材よりも近位側に配置されており、前記第1針部材と前記第2針部材は、それぞれ遠近方向に延在しており、前記第1針部材は、先端が遠位側を向いており、前記第2針部材は、先端が近位側を向いている医療用双方向縫合装置の作動方法であって
前記第1筒部材遠位側に移動るステップおよび前記第2筒部材近位側に移動るステップの少なくともいずれか一方を行うステップと、
前記第1針部材遠位側に移動、糸の一部を前記第2筒部材の近位端よりも遠位側に配置するステップと、
前記第1針部材近位側に移動るステップと、
前記第1針部材が遠位側へ移動した際の位置と異なる位置に、前記第2針部材が配置されるように前記医療用双方向縫合装置移動るステップと、
前記第2針部材近位側に移動、糸の一部を前記第1筒部材の遠位端よりも近位側に配置するステップと、
前記第2針部材遠位側に移動るステップと、
を含む医療用双方向縫合装置の作動方法。
a housing extending in the distance direction; a first needle member and a second needle member provided in the housing; and a first needle member enclosing the first needle member and movable along the distance direction. and a second tubular member that encloses the second needle member and is movable along the distance direction, wherein the first needle member is closer to the proximal side than the second needle member. , wherein the first needle member and the second needle member extend in the distal and near directions, the tip of the first needle member faces distally, and the second needle A method of operating a bi-directional medical suturing device in which the member points proximally, comprising:
performing at least one of moving the first tubular member distally and moving the second tubular member proximally;
moving the first needle member distally to position a portion of the thread distal to the proximal end of the second tubular member;
moving the first needle member proximally;
moving the bidirectional medical suturing device such that the second needle member is positioned at a position different from the position when the first needle member is moved distally;
moving the second needle member proximally to position a portion of the thread proximal to the distal end of the first tubular member;
moving the second needle member distally;
A method of operating a medical bi-directional suturing device comprising:
記医療用双方向縫合装置は、さらに前記第1針部材よりも遠位側に配置されている第1糸保持機構と、前記第2針部材の先端と前記第1糸保持機構の遠位端の間に配置されている第2糸保持機構とを含み、前記第1糸保持機構と前記第2糸保持機構は糸の保持と糸の保持解除を行うものであって、
前記第1針部材が遠位側に移動し、糸の一部を前記第2筒部材の近位端よりも遠位側に配置するステップの前に前記第1糸保持機構糸を保持するステップと、
前記医療用双方向縫合装置の遠近方向から見て、前記第1糸保持機構が前記第1針部材よりも半径方向の外側に位置するように前記第1糸保持機構ステップと、
前記第1筒部材遠位側に移動るステップおよび前記第2筒部材近位側に移動るステップの少なくともいずれか一方を行うステップを行い、
前記第1針部材近位側に移動るステップの後、前記第2糸保持機構糸を保持するステップを行い、
前記第1針部材が遠位側へ移動した際の位置と異なる位置に、前記第2針部材が配置されるように前記医療用双方向縫合装置移動るステップの後、前記医療用双方向縫合装置の遠近方向から見て、前記第2糸保持機構が前記第2針部材よりも半径方向の外側に位置するように前記第2糸保持機構ステップを行う請求項16に記載の方法。
The two -way suturing device for medical use further comprises a first thread holding mechanism disposed further distally than the first needle member, and a tip of the second needle member and a distal end of the first thread holding mechanism. a second thread retaining mechanism disposed between the ends, the first thread retaining mechanism and the second thread retaining mechanism for retaining and releasing the thread;
The first thread retention mechanism retains the thread prior to the first needle member moving distally and placing a portion of the thread distal to the proximal end of the second tubular member . a step;
moving the first thread holding mechanism so that the first thread holding mechanism is positioned radially outside of the first needle member when viewed from the perspective direction of the two-way medical suturing device;
performing at least one of moving the first tubular member distally and moving the second tubular member proximally;
after the step of moving the first needle member proximally, the step of holding the thread by the second thread holding mechanism;
After the step of moving the bidirectional medical suturing device so that the second needle member is positioned at a position different from the position when the first needle member was moved distally, the medical bilateral suturing device 17. The step of claim 16, wherein said second thread retaining mechanism is moved such that said second thread retaining mechanism is positioned radially outwardly of said second needle member when viewed in a perspective direction of the directional suturing device. the method of.
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WO2017163600A1 (en) 2016-03-25 2017-09-28 株式会社カネカ Bi-directional medical suturing device and operation method thereof

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012515636A (en) 2009-01-26 2012-07-12 ジンテス ゲゼルシャフト ミット ベシュレンクテル ハフツング Bi-directional suture threader
JP2012525224A (en) 2009-04-28 2012-10-22 ジンテス ゲゼルシャフト ミット ベシュレンクテル ハフツング Bidirectional suture insertion device
WO2017163600A1 (en) 2016-03-25 2017-09-28 株式会社カネカ Bi-directional medical suturing device and operation method thereof

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