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JP2021049191A - Concrescence acceleration device - Google Patents

Concrescence acceleration device Download PDF

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JP2021049191A
JP2021049191A JP2019174452A JP2019174452A JP2021049191A JP 2021049191 A JP2021049191 A JP 2021049191A JP 2019174452 A JP2019174452 A JP 2019174452A JP 2019174452 A JP2019174452 A JP 2019174452A JP 2021049191 A JP2021049191 A JP 2021049191A
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main body
close contact
support
fusion promoting
fusion
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美利亜 鈴木
Miria Suzuki
美利亜 鈴木
直希 荒巻
Naoki Aramaki
直希 荒巻
美穂 甲斐
Miho Kai
美穂 甲斐
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Terumo Corp
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Terumo Corp
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Abstract

To provide a concrescence acceleration device capable of reducing a risk of anastomotic leaks after a surgical operation or the like.SOLUTION: A concrescence acceleration device 100 comprises: a body 10 which is disposed between biological organs to be joined and accelerates concrescence of biological tissues; an elastic part 20 which is provided inside the body and has higher elasticity than the body; and an adhesion part 30 which is configured such that an engaged part 711 of a first engaging tool 710 used for a procedure of joining the biological organs is insertable, and causes the elastic part to adhere to the engaged part of the first engaging tool, in a state where the first engaging tool is inserted.SELECTED DRAWING: Figure 1

Description

本発明は、癒合促進デバイスに関する。 The present invention relates to a fusion promoting device.

医療の分野において、生体器官を外科的手術により接合する手技(例えば、消化管の吻合術)が知られている。上記のような手技が行われた場合、生体器官同士が接合された接合部における癒合の遅延が生じないことが術後の予後決定因子として重要であることも知られている。 In the medical field, a technique of surgically joining living organs (for example, gastrointestinal anastomosis) is known. It is also known that when the above procedure is performed, it is important as a postoperative prognosis determinant that there is no delay in fusion at the joint where the biological organs are joined.

生体器官を接合する手技では種々の方法や医療器具が用いられるが、例えば、生分解性の縫合糸により生体器官を縫合する方法や、ステープラーによる吻合を行う機械式の接合装置(特許文献1を参照)を利用する方法が提案されている。特に、機械式の接合装置を利用して吻合術を行う場合、縫合糸を用いた方法と比較して接合部における生体器官同士の接合力を高めることができるため、縫合不全のリスクを低減させることが可能になる。 Various methods and medical instruments are used in the technique of joining living organs. For example, a method of suturing a living organ with a biodegradable suture and a mechanical joining device for anastomosis with a stapler (Patent Document 1). A method using (see) has been proposed. In particular, when anastomosis is performed using a mechanical joining device, the bonding force between biological organs at the joint can be increased as compared with the method using sutures, which reduces the risk of suture failure. Will be possible.

特表2007−505708号公報Japanese Patent Application Laid-Open No. 2007-505708

しかしながら、接合部における癒合の進行の程度は、患者の接合対象部位(被接合部位)における生体組織の状態等にも依存する。そのため、例えば、特許文献1に記載されているような接合装置を使用した場合においても、患者の生体組織の状態如何によっては、縫合不全のリスクを十分に低減させることができない可能性もある。 However, the degree of progression of fusion at the junction also depends on the condition of the living tissue at the junction target site (joint site) of the patient. Therefore, for example, even when a joining device as described in Patent Document 1 is used, the risk of suture failure may not be sufficiently reduced depending on the condition of the patient's living tissue.

そこで本発明は、外科手術等の術後における縫合不全のリスクを低減させることができる癒合促進デバイスを提供することを目的とする。 Therefore, an object of the present invention is to provide a fusion promoting device capable of reducing the risk of suture failure after surgery or the like.

本発明の一実施形態に係る癒合促進デバイスは、接合対象となる生体器官の間に配置され、生体組織の癒合を促進する本体部と、前記本体部の内方に設けられ、前記本体部よりも伸縮性の高い伸縮部と、前記生体器官を接合する手技に用いる医療器具の少なくとも一部が挿通可能に構成され、前記医療器具が挿通された状態において、前記医療器具の外周部の少なくとも一部に対して前記伸縮部を密着させる密着部と、を有する。 The fusion promoting device according to the embodiment of the present invention is arranged between the biological organs to be joined, and is provided in the main body portion for promoting the fusion of the biological tissue and the inside of the main body portion, and is provided from the main body portion. Also, a highly elastic stretchable portion and at least a part of the medical device used for the procedure for joining the biological organ are configured to be insertable, and in a state where the medical device is inserted, at least one of the outer peripheral portions of the medical device is inserted. It has a close contact portion for bringing the stretchable portion into close contact with the portion.

本発明に係る癒合促進デバイスによれば、接合対象となる生体器官の間に本体部を挟み込ませることにより、生体器官の生体組織の癒合を促進することができる。また、密着部が医療器具の外周部の少なくとも一部に対して伸縮部を密着させるため、癒合促進デバイスが生体器官から脱落することを抑制することができる。以上から術者は、生体器官の縫合不全のリスクを効果的に低減させることができる。 According to the fusion promoting device according to the present invention, the fusion of the biological tissues of the biological organs can be promoted by sandwiching the main body portion between the biological organs to be joined. Further, since the close contact portion brings the elastic portion into close contact with at least a part of the outer peripheral portion of the medical device, it is possible to prevent the fusion promoting device from falling off from the living organ. From the above, the operator can effectively reduce the risk of anastomotic insufficiency of the living organ.

本発明の実施形態に係る癒合促進デバイスを示す概略斜視図である。It is a schematic perspective view which shows the fusion promotion device which concerns on embodiment of this invention. 本体部の貫通孔の構成を説明するための概略断面図である。It is the schematic sectional drawing for demonstrating the structure of the through hole of the main body part. 癒合促進デバイスを用いた処置方法の各手順を示すフローチャートである。It is a flowchart which shows each procedure of the treatment method using a fusion promotion device. 処置方法の実施形態(大腸吻合術)の手順を示すフローチャートである。It is a flowchart which shows the procedure of embodiment (colon anastomosis) of a treatment method. 大腸吻合術を説明するための模式的な断面図である。It is a schematic cross-sectional view for demonstrating colorectal anastomosis. 大腸吻合術を説明するための模式的な断面図である。It is a schematic cross-sectional view for demonstrating colorectal anastomosis. 大腸吻合術を説明するための模式的な断面図である。It is a schematic cross-sectional view for demonstrating colorectal anastomosis. 変形例1に係る癒合促進デバイスを示す概略斜視図であって、支持部が密着部を支持している状態を示す図である。It is a schematic perspective view which shows the fusion promotion device which concerns on modification 1, and is the figure which shows the state which the support part supports the close contact part. 図8の状態における変形例1に係る癒合促進デバイスを示す正面断面図である。It is a front sectional view which shows the fusion promotion device which concerns on the modification 1 in the state of FIG. 変形例1に係る癒合促進デバイスを示す概略斜視図であって、支持部および密着部が離間した状態を示す図である。It is a schematic perspective view which shows the fusion promotion device which concerns on modification 1, and is the figure which shows the state which the support part and the contact part are separated. 図10の状態における変形例1に係る癒合促進デバイスを示す正面断面図である。It is a front sectional view which shows the fusion promotion device which concerns on the modification 1 in the state of FIG. 変形例2に係る癒合促進デバイスを示す正面断面図であって、支持部が密着部を支持している状態を示す図である。It is a front sectional view which shows the fusion promotion device which concerns on modification 2, and is the figure which shows the state which the support part supports the close contact part. 変形例2に係る癒合促進デバイスを示す正面断面図であって、支持部および密着部が離間した状態を示す図である。It is a front sectional view which shows the fusion promotion device which concerns on modification 2, and is the figure which shows the state which the support part and the contact part are separated.

以下、添付した図面を参照して、本発明の実施形態を説明する。なお、図面の説明において同一の要素には同一の符号を付し、重複する説明を省略する。また、図面の寸法比率は、説明の都合上誇張され、実際の比率とは異なる場合がある。 Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. In the description of the drawings, the same elements are designated by the same reference numerals, and duplicate description will be omitted. In addition, the dimensional ratios in the drawings are exaggerated for convenience of explanation and may differ from the actual ratios.

図1〜図2は、本発明の実施形態に係る癒合促進デバイス100の構成の説明に供する図である。 1 and 2 are diagrams for explaining the configuration of the fusion promoting device 100 according to the embodiment of the present invention.

<癒合促進デバイス100>
癒合促進デバイス100は、図5〜図7に示すように、所定の生体器官同士を接合する手技(例えば、消化管の吻合術)に適用することができる。後述するように、本明細書の説明では、癒合促進デバイス100を使用した手技例として大腸吻合術を説明する。
<Union promotion device 100>
As shown in FIGS. 5 to 7, the fusion promoting device 100 can be applied to a procedure for joining predetermined biological organs (for example, gastrointestinal anastomosis). As will be described later, in the description of the present specification, colon anastomosis will be described as an example of a procedure using the fusion promoting device 100.

癒合促進デバイス100は、図1に示すように、接合対象となる生体器官の間に配置される本体部10と、本体部10の内方に設けられる伸縮部20と、接合装置700の第1係合器具710に対して伸縮部20を密着する密着部30と、を有する。以下、癒合促進デバイス100の各構成について説明する。 As shown in FIG. 1, the fusion promoting device 100 includes a main body portion 10 arranged between biological organs to be joined, an expansion / contraction portion 20 provided inside the main body portion 10, and a first joining device 700. It has a close contact portion 30 that brings the telescopic portion 20 into close contact with the engaging device 710. Hereinafter, each configuration of the fusion promoting device 100 will be described.

<本体部10>
本体部10は、生体組織の癒合を促進するシート形状によって構成されている。本体部10は、例えば、生分解性のシート部材(薄膜状の部材)で形成することができる。
<Main body 10>
The main body 10 is formed of a sheet shape that promotes fusion of living tissues. The main body 10 can be formed of, for example, a biodegradable sheet member (thin film-like member).

本体部10には、複数の貫通孔15が形成されている。複数の貫通孔15は、図1に示すように、本体部10の面方向において規則的かつ周期的に設けられている。ただし、複数の貫通孔15は、本体部10の面方向においてランダムに設けられていてもよい。 A plurality of through holes 15 are formed in the main body 10. As shown in FIG. 1, the plurality of through holes 15 are regularly and periodically provided in the surface direction of the main body 10. However, the plurality of through holes 15 may be randomly provided in the surface direction of the main body 10.

貫通孔15は、図2に示すように、本体部10の厚み方向(図2の上下方向)に沿って表面11と裏面12との間で略垂直に延びている。なお、貫通孔15は、本体部10の厚み方向に沿う断面において、表面11と裏面12との間でジグザグ状に屈曲していたり、湾曲していたりしてもよい。 As shown in FIG. 2, the through hole 15 extends substantially vertically between the front surface 11 and the back surface 12 along the thickness direction of the main body 10 (vertical direction in FIG. 2). The through hole 15 may be bent or curved in a zigzag shape between the front surface 11 and the back surface 12 in a cross section along the thickness direction of the main body 10.

貫通孔15は、略円形の平面形状(本体部10の表面11または裏面12を平面視した際の形状)を有する。ただし、貫通孔15の平面形状は、特に限定されず、例えば、楕円形や多角形(矩形や三角形等)であってもよい。また、貫通孔15ごとに平面形状や断面形状が異なっていてもよい。 The through hole 15 has a substantially circular planar shape (shape when the front surface 11 or the back surface 12 of the main body 10 is viewed in a plan view). However, the planar shape of the through hole 15 is not particularly limited, and may be, for example, an ellipse or a polygon (rectangle, triangle, etc.). Further, the planar shape and the cross-sectional shape may be different for each through hole 15.

本体部10は、略円形の形状を有する。ただし、本体部10の形状は、特に限定されず、例えば、楕円形や多角形(矩形や三角形等)であってもよい。 The main body 10 has a substantially circular shape. However, the shape of the main body 10 is not particularly limited, and may be, for example, an ellipse or a polygon (rectangle, triangle, etc.).

本体部10の厚みT(図2参照)は、特に制限されないが、好ましくは0.05〜0.3mmであり、より好ましくは0.1〜0.2mmである。本体部10の厚みが0.05mm以上である場合(特に0.1mm以上である場合)、癒合促進デバイス100の取り扱い時に本体部10が破損しない程度の強度を備えさせることができる。一方、本体部10の厚みが0.3mm以下である場合(特に0.2mm以下である場合)、本体部10が適用される生体組織に本体部10が密着して生体組織に追随するのに十分な柔軟性を備えさせることができる。 The thickness T (see FIG. 2) of the main body 10 is not particularly limited, but is preferably 0.05 to 0.3 mm, more preferably 0.1 to 0.2 mm. When the thickness of the main body 10 is 0.05 mm or more (particularly 0.1 mm or more), the strength is such that the main body 10 is not damaged when the fusion promoting device 100 is handled. On the other hand, when the thickness of the main body 10 is 0.3 mm or less (particularly 0.2 mm or less), the main body 10 adheres to the biological tissue to which the main body 10 is applied and follows the biological tissue. It can be provided with sufficient flexibility.

本体部10は、貫通孔15のピッチP(図2に示す距離Pであり、隣り合う貫通孔15の間の距離)に対する貫通孔15の孔径D(図2に示す距離D)の比の値が、0.25以上40未満であることが好ましい。なお、貫通孔15の平面形状が真円である場合、貫通孔15の孔径Dは真円の直径に等しくなる。一方、貫通孔15の平面形状が真円ではない場合には、貫通孔15の開口部(貫通孔15において表面11または裏面12に面した部分)の面積と同じ面積を有する真円の直径(円相当径)を当該貫通孔15の孔径Dとすることができる。 The main body 10 is a value of the ratio of the hole diameter D (distance D shown in FIG. 2) of the through hole 15 to the pitch P of the through hole 15 (distance P shown in FIG. 2 and the distance between adjacent through holes 15). However, it is preferably 0.25 or more and less than 40. When the planar shape of the through hole 15 is a perfect circle, the hole diameter D of the through hole 15 is equal to the diameter of the perfect circle. On the other hand, when the planar shape of the through hole 15 is not a perfect circle, the diameter of a perfect circle having the same area as the area of the opening of the through hole 15 (the portion of the through hole 15 facing the front surface 11 or the back surface 12) ( The equivalent circle diameter) can be the hole diameter D of the through hole 15.

本体部10は、複数の貫通孔15を有するため、各貫通孔15に対応する孔径Dの値が複数存在する。そこで、本実施形態では、上述した比の値を算出するにあたっては、複数の貫通孔15にそれぞれ対応する孔径Dの値の2点以上の算術平均値を孔径Dの代表値として用いるものとする。一方、複数の貫通孔15のピッチPは、2つの貫通孔15の開口部同士の最短距離で定義する。ただし、ピッチPの値についても隣り合う貫通孔15の組み合わせに対応するピッチPの値が複数存在する。したがって、本実施形態では、上述した比の値を算出するにあたっては、隣り合う貫通孔15の組み合わせにそれぞれ対応するピッチPの値の2点以上の算術平均値をピッチPの代表値として用いるものとする。 Since the main body 10 has a plurality of through holes 15, there are a plurality of values of the hole diameter D corresponding to each through hole 15. Therefore, in the present embodiment, in calculating the above-mentioned ratio value, the arithmetic mean value of two or more points of the hole diameter D values corresponding to the plurality of through holes 15 is used as the representative value of the hole diameter D. .. On the other hand, the pitch P of the plurality of through holes 15 is defined by the shortest distance between the openings of the two through holes 15. However, as for the value of the pitch P, there are a plurality of values of the pitch P corresponding to the combination of the adjacent through holes 15. Therefore, in the present embodiment, in calculating the above-mentioned ratio value, the arithmetic mean value of two or more points of the pitch P values corresponding to the combinations of the adjacent through holes 15 is used as the representative value of the pitch P. And.

なお、上記の貫通孔15のピッチP、孔径D、ピッチPに対する孔径Dの比等は、一例であり、これに限定されることはない。 The pitch P, the hole diameter D, the ratio of the hole diameter D to the pitch P, and the like of the through hole 15 are examples, and are not limited thereto.

本体部10は、生分解性の材料で構成することができる。本体部10の構成材料について特に制限はなく、例えば、生分解性樹脂が挙げられる。生分解性樹脂としては、例えば、特表2011−528275号公報、特表2008−514719号公報、国際公報第2008−1952号、特表2004−509205号公報等に記載されるものなどの公知の生分解性(共)重合体が使用できる。具体的には、(1)脂肪族ポリエステル、ポリエステル、ポリ酸無水物、ポリオルソエステル、ポリカーボネート、ポリホスファゼン、ポリリン酸エステル、ポリビニルアルコール、ポリペプチド、多糖、タンパク質、セルロースからなる群から選択される重合体;(2)上記(1)を構成する一以上の単量体から構成される共重合体などが挙げられる。すなわち、生分解性シートは、脂肪族ポリエステル、ポリエステル、ポリ酸無水物、ポリオルソエステル、ポリカーボネート、ポリホスファゼン、ポリリン酸エステル、ポリビニルアルコール、ポリペプチド、多糖、タンパク質、セルロースからなる群から選択される重合体、ならびに前記重合体を構成する一以上の単量体から構成される共重合体からなる群より選択される少なくとも一種の生分解性樹脂を含むことが好ましい。 The main body 10 can be made of a biodegradable material. The constituent material of the main body 10 is not particularly limited, and examples thereof include biodegradable resins. Known biodegradable resins include those described in, for example, Japanese Patent Publication No. 2011-528275, Japanese Patent Publication No. 2008-514719, International Publication No. 2008-1952, and Japanese Patent Publication No. 2004-509205. Biodegradable (co) polymers can be used. Specifically, it is selected from the group consisting of (1) aliphatic polyester, polyester, polyacid anhydride, polyorthoester, polycarbonate, polyphosphazene, polyphosphate ester, polyvinyl alcohol, polypeptide, polysaccharide, protein, and cellulose. Polymer; (2) A copolymer composed of one or more monomers constituting the above (1) and the like can be mentioned. That is, the biodegradable sheet is selected from the group consisting of aliphatic polyesters, polyesters, polyacid anhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphates, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and celluloses. It preferably contains at least one biodegradable resin selected from the group consisting of a polymer and a copolymer composed of one or more monomers constituting the polymer.

本体部10の製造方法は特に限定されないが、例えば、上述した生分解性樹脂からなる繊維を作製し、当該繊維を用いてメッシュ形状のシートを製造する方法が挙げられる。生分解性樹脂からなる繊維を作製する方法としては、特に限定されないが、例えば、エレクトロスピニング法(電界紡糸法・静電紡糸法)や、メルトブロー法等が挙げられる。本体部10は、上記の方法のうち1種のみを選択して用いてもよいし、2種以上を選択し適宜組み合わせてもよい。なお、本体部10の製造方法の別の例として、上述した生分解性樹脂からなる繊維を常法に従って紡糸し、得られた繊維をメッシュ状に編むことによって本発明に係る生分解性シートを製造してもよい。 The method for producing the main body 10 is not particularly limited, and examples thereof include a method for producing a fiber made of the biodegradable resin described above and using the fiber to produce a mesh-shaped sheet. The method for producing the fiber made of a biodegradable resin is not particularly limited, and examples thereof include an electrospinning method (electrospinning method / electrostatic spinning method) and a melt blow method. As the main body 10, only one of the above methods may be selected and used, or two or more of the above methods may be selected and appropriately combined. As another example of the method for manufacturing the main body 10, the biodegradable sheet according to the present invention is obtained by spinning the fibers made of the biodegradable resin described above according to a conventional method and knitting the obtained fibers into a mesh shape. It may be manufactured.

本体部10は、本体部10を構成する生分解性樹脂等の構成材料によって生体反応を惹起させる。本体部10は、この作用により、フィブリン等の生体成分の発現を誘導する。このようにして誘導された生体成分は、本体部10の貫通孔15を貫通するようにして集積することで、癒合を促進することができる。したがって、接合対象となる生体器官同士の間に、本体部10を配置することにより、上記のメカニズムによる癒合の促進が生じる。 The main body 10 induces a biological reaction by a constituent material such as a biodegradable resin constituting the main body 10. The main body 10 induces the expression of biological components such as fibrin by this action. The biological components induced in this way can promote fusion by accumulating so as to penetrate through the through hole 15 of the main body 10. Therefore, by arranging the main body portion 10 between the biological organs to be joined, the fusion is promoted by the above mechanism.

なお、本体部10の材質は、生体器官の癒合を促進させることが可能であれば、生分解性でなくてもよい。また、本体部10は、生体器官の癒合を促進させることが可能であれば、材質に関わらず、貫通孔15が形成されていなくてもよい。 The material of the main body 10 does not have to be biodegradable as long as it can promote the fusion of biological organs. Further, the main body portion 10 may not have a through hole 15 formed regardless of the material as long as it can promote the fusion of living organs.

本体部10は、図1に示すように、本体部10の内縁に沿って配置される内縁補強部13と、本体部10の外縁に沿って配置される外縁補強部14と、を有する。 As shown in FIG. 1, the main body portion 10 has an inner edge reinforcing portion 13 arranged along the inner edge of the main body portion 10 and an outer edge reinforcing portion 14 arranged along the outer edge of the main body portion 10.

内縁補強部13は、本体部10の他の部分よりも剛性が高くなるように構成されている。内縁補強部13は、本体部10の周方向に沿って全範囲に亘って形成している。このように本体部10は内縁補強部13を有するため、本体部10の内縁がよれて変形することを抑制することができる。なお、内縁補強部13は、内周縁の一部のみに形成してもよい。 The inner edge reinforcing portion 13 is configured to have a higher rigidity than the other portions of the main body portion 10. The inner edge reinforcing portion 13 is formed over the entire range along the circumferential direction of the main body portion 10. Since the main body portion 10 has the inner edge reinforcing portion 13 in this way, it is possible to prevent the inner edge of the main body portion 10 from being twisted and deformed. The inner edge reinforcing portion 13 may be formed only on a part of the inner peripheral edge.

外縁補強部14は、本体部10の他の部分よりも剛性が高くなるように構成されている。外縁補強部14は、本体部10の周方向に沿って全範囲に亘って形成している。このように本体部10は外縁補強部14を有するため、本体部10の外縁がよれて変形することを抑制することができる。なお、外縁補強部14は、外周縁の一部のみに形成してもよい。 The outer edge reinforcing portion 14 is configured to have higher rigidity than the other portions of the main body portion 10. The outer edge reinforcing portion 14 is formed over the entire range along the circumferential direction of the main body portion 10. Since the main body portion 10 has the outer edge reinforcing portion 14 in this way, it is possible to prevent the outer edge of the main body portion 10 from being twisted and deformed. The outer edge reinforcing portion 14 may be formed only on a part of the outer peripheral edge.

内縁補強部13および外縁補強部14を形成する方法は、特に限定されない。内縁補強部13および外縁補強部14は、本体部10の外表面の一部に一体に形成されていてもよく、本体部10と別体であり本体部10の外表面の一部に接続されていてもよい。例えば、本体部10と別体で形成された補強部材を、本体部10の外周縁または内周縁に固定させることによって設けられてもよい。補強部材としては、例えば、孔部が形成されていない生分解性シートや、本体部10よりも高い剛性を備える樹脂製のシート等で構成することができる。 The method for forming the inner edge reinforcing portion 13 and the outer edge reinforcing portion 14 is not particularly limited. The inner edge reinforcing portion 13 and the outer edge reinforcing portion 14 may be integrally formed on a part of the outer surface of the main body portion 10, are separate from the main body portion 10, and are connected to a part of the outer surface of the main body portion 10. You may be. For example, a reinforcing member formed separately from the main body portion 10 may be provided by fixing it to the outer peripheral edge or the inner peripheral edge of the main body portion 10. The reinforcing member may be, for example, a biodegradable sheet having no holes formed therein, a resin sheet having a higher rigidity than the main body portion 10, or the like.

また、本体部10の構成材料となる生分解性シートの外周縁および内周縁に貫通孔15を形成させないことにより、本体部10に内縁補強部13および外縁補強部14を設けることも可能である。 Further, it is also possible to provide the inner edge reinforcing portion 13 and the outer edge reinforcing portion 14 in the main body portion 10 by not forming the through holes 15 in the outer peripheral edge and the inner peripheral edge of the biodegradable sheet which is the constituent material of the main body portion 10. ..

また、本体部10の構成材料となる生分解性シートの外周縁および内周縁に貫通孔15を形成した後、外周縁および内周縁のみを厚み方向に圧縮したり加熱したりして、貫通孔15を押し潰すことにより、生分解性シートの構成材料が密に集合した部分を形成し、当該部分を内縁補強部13および外縁補強部14としてもよい。 Further, after forming through holes 15 in the outer peripheral edge and the inner peripheral edge of the biodegradable sheet which is a constituent material of the main body 10, only the outer peripheral edge and the inner peripheral edge are compressed or heated in the thickness direction to form the through holes. By crushing 15, a portion where the constituent materials of the biodegradable sheet are densely assembled may be formed, and the portions may be used as the inner edge reinforcing portion 13 and the outer edge reinforcing portion 14.

<伸縮部20>
伸縮部20は、図1に示すように、本体部10の内縁補強部13の内方に設けられる。伸縮部20は、本体部10の貫通孔15が設けられる箇所よりも伸縮性が高くなるように構成されている。伸縮部20は、例えば接着剤によって本体部10に固定されている。
<Expandable part 20>
As shown in FIG. 1, the telescopic portion 20 is provided inside the inner edge reinforcing portion 13 of the main body portion 10. The stretchable portion 20 is configured to have higher elasticity than the portion where the through hole 15 of the main body portion 10 is provided. The stretchable portion 20 is fixed to the main body portion 10 with, for example, an adhesive.

伸縮部20を構成する材料としては特に限定されないが、例えば、弾性部材であるシリコーンゴム、ラテックスゴム、ブチルゴム、イソプレンゴム等が挙げられる。 The material constituting the elastic portion 20 is not particularly limited, and examples thereof include silicone rubber, latex rubber, butyl rubber, and isoprene rubber, which are elastic members.

伸縮部20は、図5に示す接合装置700の第1係合器具710および第2係合器具720が、本体部10を間に挟んで対向して重なる領域E1(図7参照)よりも内方側に位置することが好ましい。 The telescopic portion 20 is inside the region E1 (see FIG. 7) in which the first engaging instrument 710 and the second engaging instrument 720 of the joining device 700 shown in FIG. 5 are opposed to each other with the main body portion 10 sandwiched between them. It is preferably located on the side.

このように伸縮部20が構成されることによって、接合装置700によって、癒合促進デバイス100を打ち抜いた際に、伸縮部20を打ち抜くことができ、本体部10のみが、一対の生体器官の間に配置されるため、一対の生体器官を好適に接合することができる。 By configuring the telescopic portion 20 in this way, when the fusion promoting device 100 is punched out by the joining device 700, the telescopic portion 20 can be punched out, and only the main body portion 10 is between the pair of biological organs. Because of the arrangement, a pair of biological organs can be suitably joined.

<密着部30>
密着部30は、図5〜図7に示すように、後述する第1係合器具710の被係合部711(シャフトに相当)が挿通可能に構成され、被係合部711が挿通された状態において、被係合部711に対して伸縮部20を密着させる。
<Adhesion part 30>
As shown in FIGS. 5 to 7, the close contact portion 30 is configured so that the engaged portion 711 (corresponding to the shaft) of the first engaging device 710 described later can be inserted, and the engaged portion 711 is inserted. In the state, the expansion / contraction portion 20 is brought into close contact with the engaged portion 711.

密着部30は、図1に示すように、伸縮部20のうち内方に位置する内方部31と、伸縮部20の内方に位置する孔部32と、を有する。内方部31は、伸縮部20の一部を構成する。孔部32の孔径は、第1係合器具710の被係合部711の外径よりも小さい。このように構成された密着部30によれば、孔部32に被係合部711が挿通された状態において、被係合部711に対して内方部31を密着させる。このため、手技の最中において、癒合促進デバイス100が生体器官から脱落することを抑制することができる。 As shown in FIG. 1, the close contact portion 30 has an inner portion 31 located inward of the telescopic portion 20 and a hole portion 32 located inward of the telescopic portion 20. The inner portion 31 constitutes a part of the telescopic portion 20. The hole diameter of the hole portion 32 is smaller than the outer diameter of the engaged portion 711 of the first engaging instrument 710. According to the close contact portion 30 configured in this way, the inner portion 31 is brought into close contact with the engaged portion 711 in a state where the engaged portion 711 is inserted through the hole portion 32. Therefore, it is possible to prevent the fusion promoting device 100 from falling out of the living organ during the procedure.

<処置方法の実施形態(生体器官吻合術)>
次に、本実施形態に係る癒合促進デバイス100を用いた処置方法を説明する。
<Example of treatment method (living organ anastomosis)>
Next, a treatment method using the fusion promoting device 100 according to the present embodiment will be described.

図3は、本実施形態に係る癒合促進デバイス100を用いた処置方法の各手順を示すフローチャートである。 FIG. 3 is a flowchart showing each procedure of the treatment method using the fusion promoting device 100 according to the present embodiment.

処置方法は、生体器官の接合対象となる一方の被接合部位と他方の被接合部位との間に生体組織の癒合を促進するシート状の本体部10を備える癒合促進デバイス100を配置すること(S11)、一方の被接合部位と他方の被接合部位との間に癒合促進デバイス100の本体部10の少なくとも一部を配置した状態で一方の被接合部位と他方の被接合部位とを接合すること(S12)、を含む。 The treatment method is to dispose a fusion promoting device 100 having a sheet-shaped main body portion 10 that promotes fusion of living tissues between one bonded site to be joined and the other bonded site of the living organ ( S11), one joined portion and the other joined portion are joined in a state where at least a part of the main body 10 of the fusion promoting device 100 is arranged between one joined portion and the other joined portion. That (S12), including.

処置方法により接合される生体器官および生体器官における被接合部位は特に限定されず、任意に選択することができる。ただし、以下の説明では、大腸吻合術を例に挙げて説明する。また、以下に説明する各手技において、公知の手技手順や公知の接合装置については詳細な説明を適宜省略する。 The living organ to be joined by the treatment method and the site to be joined in the living organ are not particularly limited and can be arbitrarily selected. However, in the following description, colon anastomosis will be described as an example. Further, in each of the procedures described below, detailed description of known procedure procedures and known joining devices will be omitted as appropriate.

以下、本明細書の説明において「生体器官の間に癒合促進デバイス100を配置する」とは、生体器官に癒合促進デバイス100が直接的にまたは間接的に接触した状態で配置されること、生体器官との間に空間的な隙間が形成された状態で癒合促進デバイス100が配置されること、またはその両方の状態で癒合促進デバイス100が配置されること(例えば、一方の生体器官に癒合促進デバイス100が接触し、他方の生体器官には癒合促進デバイス100が接触していない状態で配置されること)の少なくとも一つを意味する。また、本明細書の説明において「周辺」とは、厳密な範囲(領域)を規定するものではなく、処置の目的(生体器官同士の接合)を達成し得る限りにおいて、所定の範囲(領域)を意味する。また、各処置方法において説明する手技手順は、処置の目的を達成し得る限りにおいて、順番を適宜入れ替えることが可能である。また、本明細書の説明において「相対的に接近させる」とは、接近させる対象となる2つ以上のものを、互いに接近させること、一方のみを他方のみに接近させることの両方を意味する。 Hereinafter, in the description of the present specification, "arranging the fusion promoting device 100 between the biological organs" means that the fusion promoting device 100 is arranged in a state of direct or indirect contact with the biological organ, that is, the living body. The fusion promoting device 100 is arranged in a state where a spatial gap is formed between the organ and the fusion promoting device 100, or the fusion promoting device 100 is arranged in both states (for example, fusion promoting in one biological organ). It means at least one of (the device 100 is in contact with the other biological organ and the fusion promoting device 100 is placed in a non-contact state). Further, in the description of the present specification, the term "periphery" does not define a strict range (region), but a predetermined range (region) as long as the purpose of treatment (bonding between biological organs) can be achieved. Means. In addition, the order of the procedure procedures described in each treatment method can be changed as appropriate as long as the purpose of the treatment can be achieved. Further, in the description of the present specification, "relatively approaching" means both bringing two or more objects to be approached close to each other and bringing only one close to the other.

<処置方法の実施形態(大腸吻合術)>
図4は、処置方法の実施形態(大腸吻合術)の手順を示すフローチャートであり、図5〜図7は、大腸吻合術の説明に供する図である。
<Example of treatment method (colon anastomosis)>
FIG. 4 is a flowchart showing the procedure of the embodiment of the treatment method (colon anastomosis), and FIGS. 5 to 7 are diagrams used for explaining the colon anastomosis.

本実施形態に係る癒合促進デバイス100の処置方法において、接合対象となる生体器官は、癌腫瘍の切除に伴い切断された大腸である。具体的には、接合対象となる生体器官は、切断した大腸の口側A1と、切断した大腸の肛門側A2である。以下の説明では、切断した大腸の口側A1の口部周辺(一方の被接合部位)と、切断した大腸の肛門側A2の腸壁の一部(他方の被接合部位)を接合する手順を説明する。 In the treatment method of the fusion promoting device 100 according to the present embodiment, the biological organ to be joined is the large intestine that has been cut due to the excision of the cancer tumor. Specifically, the biological organs to be joined are the oral side A1 of the cut large intestine and the anal side A2 of the cut large intestine. In the following description, the procedure for joining the area around the mouth of the cut colon on the oral side A1 (one joined site) and a part of the intestinal wall on the anal side A2 of the cut large intestine (the other joined site) will be described. explain.

図4に示すように、本実施形態に係る処置方法は、大腸の口部周辺と大腸の腸壁の間に癒合促進デバイス100を配置すること(S101)、大腸の口部周辺と大腸の腸壁を相対的に接近させること(S102)、大腸の口部周辺と大腸の腸壁との間で癒合促進デバイス100の本体部10を挟み込むこと(S103)、大腸の口部周辺と大腸の腸壁との間に癒合促進デバイス100に本体部10を挟み込んだ状態で接合すること(S104)、大腸の口部周辺と大腸の腸壁との間に癒合促進デバイス100の本体部10を留置すること(S105)、を含む。 As shown in FIG. 4, the treatment method according to the present embodiment is to dispose the fusion promoting device 100 between the area around the mouth of the large intestine and the intestinal wall of the large intestine (S101), the area around the mouth of the large intestine and the intestine of the large intestine. The walls are relatively close to each other (S102), the main body 10 of the fusion promoting device 100 is sandwiched between the area around the mouth of the large intestine and the intestinal wall of the large intestine (S103), the area around the mouth of the large intestine and the intestine of the large intestine. The main body 10 is sandwiched between the fusion promoting device 100 and the wall (S104), and the main body 10 of the large intestine is placed between the vicinity of the mouth of the large intestine and the intestinal wall of the large intestine. (S105), including.

次に、図5〜図7を参照して、本実施形態に係る処置方法を具体的に説明する。 Next, the treatment method according to the present embodiment will be specifically described with reference to FIGS. 5 to 7.

図5に示すように、術者は、大腸の口側A1に、接合装置700の第1係合器具710を挿入する。また、術者は、大腸の肛門側A2に、接合装置700の第2係合器具720を配置する。第2係合器具720を大腸の肛門側A2に配置(挿入)するのに伴って、大腸の肛門側A2に貫通孔A21が形成される。なお、貫通孔A21を形成するタイミングは、第2係合器具720を配置する前であれば、特に限定されない。 As shown in FIG. 5, the operator inserts the first engaging instrument 710 of the joining device 700 into the oral side A1 of the large intestine. In addition, the operator places the second engaging device 720 of the joining device 700 on the anal side A2 of the large intestine. As the second engaging device 720 is placed (inserted) on the anal side A2 of the large intestine, a through hole A21 is formed in the anal side A2 of the large intestine. The timing of forming the through hole A21 is not particularly limited as long as it is before the second engaging device 720 is arranged.

接合装置700としては、例えば、大腸吻合術に使用される公知の装置を用いることができる。接合装置700を構成する第1係合器具710および第2係合器具720としては、例えば、アンビルとトロッカーを挙げることができる。接合装置700は、第1係合器具710と第2係合器具720の係合に伴い、第1係合器具710と第2係合器具720との間に配置された生体組織の切除とともに、切除した生体組織の周囲をステープルにより円周状に縫合する。第1係合器具710は、例えば、筒状の被係合部711(シャフトに相当)を備える器具であり、第2係合器具720は、例えば、第1係合器具710の被係合部711に挿入および係合される係合ピン721を備える器具である。 As the joining device 700, for example, a known device used for colorectal anastomosis can be used. Examples of the first engaging instrument 710 and the second engaging instrument 720 constituting the joining device 700 include an anvil and a trocar. With the engagement of the first engaging instrument 710 and the second engaging instrument 720, the joining device 700 together with excision of the biological tissue arranged between the first engaging instrument 710 and the second engaging instrument 720. The circumference of the excised living tissue is sewn in a circumferential shape with a staple. The first engaging instrument 710 is, for example, an instrument provided with a tubular engaged portion 711 (corresponding to a shaft), and the second engaging instrument 720 is, for example, an engaged portion of the first engaging instrument 710. An instrument comprising an engagement pin 721 that is inserted and engaged with the 711.

術者は、図5に示すように、第1係合器具710の被係合部711を大腸の口側A1に挿入し、被係合部711を突出した状態で巾着縫合し、縫合部A11を形成する。縫合部A11の外表面は、縫合に伴い凸側に部分的に突出した形状となる。 As shown in FIG. 5, the operator inserts the engaged portion 711 of the first engaging device 710 into the oral side A1 of the large intestine, purse-sews the engaged portion 711 in a protruding state, and sutures the sutured portion A11. To form. The outer surface of the sewn portion A11 has a shape that partially protrudes to the convex side with sewn.

次に、術者は、図5に示すように、大腸の口側A1と大腸の肛門側A2との間に癒合促進デバイス100を配置する。そして、術者は、第1係合器具710が備える被係合部711を密着部30の孔部32に通す。このとき、密着部30の孔部32に第1係合器具710の被係合部711が挿通された状態において、被係合部711に対して密着部30の内方部31を密着させる。このため、術者が手技を行っている間に、癒合促進デバイス100が大腸の口側A1から脱落することを防止することができる。 Next, as shown in FIG. 5, the operator places the fusion promoting device 100 between the oral side A1 of the large intestine and the anal side A2 of the large intestine. Then, the operator passes the engaged portion 711 included in the first engaging instrument 710 through the hole portion 32 of the close contact portion 30. At this time, in a state where the engaged portion 711 of the first engaging device 710 is inserted into the hole 32 of the close contact portion 30, the inner portion 31 of the close contact portion 30 is brought into close contact with the engaged portion 711. Therefore, it is possible to prevent the fusion promoting device 100 from falling off from the oral side A1 of the large intestine while the operator is performing the procedure.

次に、術者は、図6に示すように、第1係合器具710と第2係合器具720を相対的に接近させて係合させる。術者は、第1係合器具710と第2係合器具720との間に、大腸の口側A1の口部周辺、癒合促進デバイス100、大腸の肛門側A2の腸壁に形成した貫通孔A21周辺を挟み込む。術者は、第1係合器具710と第2係合器具720との間に挟み込まれた大腸の口側A1の一部と、癒合促進デバイス100の伸縮部20と、癒合促進デバイス100の密着部30と、大腸の肛門側A2の一部と、を接合装置700によって切除する。また、同時に、術者は、接合装置700を操作することにより、切除した部位の周囲をステープル(図示省略)により接合する。 Next, as shown in FIG. 6, the operator brings the first engaging instrument 710 and the second engaging instrument 720 relatively close to each other and engages with each other. The surgeon formed a through hole formed between the first engaging device 710 and the second engaging device 720 around the mouth of the oral side A1 of the large intestine, the fusion promoting device 100, and the intestinal wall of the anal side A2 of the large intestine. The area around A21 is sandwiched. The surgeon puts a part of the oral side A1 of the large intestine sandwiched between the first engaging instrument 710 and the second engaging instrument 720, the telescopic portion 20 of the fusion promoting device 100, and the fusion promoting device 100 into close contact with each other. The portion 30 and a part of the anal side A2 of the large intestine are excised by the joining device 700. At the same time, the operator operates the joining device 700 to join the periphery of the excised portion with staples (not shown).

次に、術者は、図7に示すように、接合装置700を、例えば、大腸の肛門側A2から肛門を介して生体外へ取り出す。ここで、上記手技において、接合装置700は、第1係合器具710または第2係合器具720に内蔵された打ち抜き刃(図示省略)によって、接合装置700に挟み込まれた各構成部材を打ち抜く。したがって、接合装置700が接合した生体器官を打ち抜く領域E2は、第1係合器具710と第2係合器具720とが癒合促進デバイス100を間に挟んで対向して重なる領域E1よりも内方側に位置する。 Next, as shown in FIG. 7, the operator takes out the joining device 700 from, for example, the anal side A2 of the large intestine to the outside of the living body via the anus. Here, in the above procedure, the joining device 700 punches each component sandwiched between the joining device 700 by a punching blade (not shown) built in the first engaging tool 710 or the second engaging tool 720. Therefore, the region E2 for punching the living organ to which the joining device 700 is joined is inward of the region E1 in which the first engaging device 710 and the second engaging device 720 are opposed to each other with the fusion promoting device 100 in between. Located on the side.

このような処置方法によれば、癒合促進デバイス100が備えるシート状の本体部10を一方の被接合部位と他方の被接合部位との間に挟み込ませるという簡便な方法により、接合手技(例えば、消化管の吻合術)後の縫合不全のリスクを低減させることができる。 According to such a treatment method, a joining technique (for example, a joining technique (for example,) is performed by a simple method in which the sheet-shaped main body portion 10 included in the fusion promoting device 100 is sandwiched between one joined portion and the other joined portion. The risk of suture failure after gastrointestinal anastomosis) can be reduced.

以上説明したように、本実施形態に係る癒合促進デバイス100は、接合対象となる生体器官の間に配置され、生体組織の癒合を促進する本体部10と、本体部10の内方に設けられ、本体部10よりも伸縮性の高い伸縮部20と、生体器官を接合する手技に用いる接合装置700の少なくとも一部が挿通可能に構成され、接合装置700が挿通された状態において、接合装置700の外周部の少なくとも一部に対して伸縮部20を密着させる密着部30と、を有する。このように構成された癒合促進デバイス100によれば、接合対象となる生体器官の間に本体部10を挟み込ませることにより、生体器官の生体組織の癒合を促進することができる。また、密着部30が接合装置700の外周部の少なくとも一部に対して伸縮部20を密着させるため、癒合促進デバイス100が生体器官から脱落することを抑制することができる。以上から術者は、生体器官の縫合不全のリスクを効果的に低減させることができる。 As described above, the fusion promoting device 100 according to the present embodiment is arranged between the biological organs to be joined, and is provided inside the main body portion 10 and the main body portion 10 for promoting the fusion of living tissues. The joining device 700 is configured so that at least a part of the stretching portion 20 having higher elasticity than the main body portion 10 and the joining device 700 used for the procedure for joining the living organs can be inserted, and the joining device 700 is inserted. It has a close contact portion 30 that brings the stretchable portion 20 into close contact with at least a part of the outer peripheral portion of the above. According to the fusion promoting device 100 configured in this way, the fusion of the biological tissues of the biological organs can be promoted by sandwiching the main body portion 10 between the biological organs to be joined. Further, since the close contact portion 30 brings the elastic portion 20 into close contact with at least a part of the outer peripheral portion of the joining device 700, it is possible to prevent the fusion promoting device 100 from falling off from the living organ. From the above, the operator can effectively reduce the risk of anastomotic insufficiency of the living organ.

また、接合装置700は、生体器官の一方の被接合部位に配置される第1係合器具710と、生体器官の他方の被接合部位に配置され、第1係合器具710と対向する第2係合器具720とを備えた接合装置700である。密着部30は、第1係合器具710の被係合部711が挿通可能に構成され、被係合部711が挿通された状態において、被係合部711に対して伸縮部20を密着させる。このように構成された癒合促進デバイス100によれば、密着部30が接合装置700の第1係合器具710の被係合部711に対して伸縮部20を密着させるため、癒合促進デバイス100が生体器官から脱落することを抑制することができる。 Further, the joining device 700 has a first engaging device 710 arranged at one of the joined parts of the living organ and a second engaging device 710 arranged at the other joined part of the living organ and facing the first engaging device 710. A joining device 700 including an engaging device 720. The close contact portion 30 is configured so that the engaged portion 711 of the first engaging device 710 can be inserted, and the telescopic portion 20 is brought into close contact with the engaged portion 711 in a state where the engaged portion 711 is inserted. .. According to the fusion promoting device 100 configured in this way, the adhesion promoting device 100 causes the fusion promoting device 100 to be brought into close contact with the engaged portion 711 of the first engaging device 710 of the joining device 700 because the contact portion 30 is brought into close contact with the engaged portion 711. It is possible to prevent it from falling out of a living organ.

また、密着部30は、伸縮部20のうち内方に位置する内方部31と、伸縮部20の内方に位置する孔部32と、を有する。このように構成された癒合促進デバイス100によれば、伸縮部20の一部が密着部30の構成要素となるため、簡易な構成で、生体器官から脱落することを抑制することができる。 Further, the close contact portion 30 has an inner portion 31 located inward of the telescopic portion 20 and a hole portion 32 located inward of the telescopic portion 20. According to the fusion promoting device 100 configured in this way, since a part of the expansion / contraction portion 20 becomes a component of the close contact portion 30, it is possible to suppress the detachment from the living organ with a simple configuration.

また、伸縮部20および密着部30は、第1係合器具710と第2係合器具720によって本体部10を生体組織に接合する際に、第1係合器具710と第2係合器具720とが、本体部10を間に挟んで対向して重なる領域よりも内方側に位置する。このように構成された癒合促進デバイス100によれば、接合装置700によって、癒合促進デバイス100を打ち抜いた際に、伸縮部20および密着部30を確実に打ち抜くことができ、本体部10のみが、一対の生体器官の間に配置されるため、一対の生体器官を好適に接合することができる。 Further, the telescopic portion 20 and the close contact portion 30 are the first engaging instrument 710 and the second engaging instrument 720 when the main body portion 10 is joined to the living tissue by the first engaging instrument 710 and the second engaging instrument 720. Is located on the inner side of the region where the main body 10 is sandwiched between them and they face each other and overlap each other. According to the fusion promoting device 100 configured in this way, when the fusion promoting device 100 is punched out by the joining device 700, the expansion / contraction portion 20 and the close contact portion 30 can be reliably punched out, and only the main body portion 10 can be punched out. Since it is arranged between a pair of biological organs, the pair of biological organs can be suitably joined.

また、本体部10は、本体部10の内縁に沿って配置され本体部10を補強する内縁補強部13を有する。このように構成された癒合促進デバイス100によれば、本体部10の内縁がよれて変形することを抑制することができる。 Further, the main body portion 10 has an inner edge reinforcing portion 13 that is arranged along the inner edge of the main body portion 10 and reinforces the main body portion 10. According to the fusion promoting device 100 configured in this way, it is possible to prevent the inner edge of the main body 10 from being twisted and deformed.

また、本体部10は、本体部10の外縁に沿って配置され本体部10を補強する外縁補強部14を有する。このように構成された癒合促進デバイス100によれば、本体部10の外縁がよれて変形することを抑制することができる。 Further, the main body portion 10 has an outer edge reinforcing portion 14 that is arranged along the outer edge of the main body portion 10 and reinforces the main body portion 10. According to the fusion promoting device 100 configured in this way, it is possible to prevent the outer edge of the main body 10 from being twisted and deformed.

以上、実施形態を通じて癒合促進デバイス100について説明したが、上記実施形態の記載に限定されるものではなく、その要旨を逸脱しない範囲において種々の変形が可能である。以下、癒合促進デバイスの変形例について説明する。変形例の説明において、上述の実施形態に係る癒合促進デバイス100で説明した構成や内容については、その説明を適宜省略する。 Although the fusion promoting device 100 has been described above through the embodiments, the device 100 is not limited to the description of the above embodiment, and various modifications can be made without departing from the gist thereof. Hereinafter, a modified example of the fusion promoting device will be described. In the description of the modified example, the description of the configuration and contents described in the fusion promoting device 100 according to the above-described embodiment will be omitted as appropriate.

<変形例1>
図8〜図11を参照して、変形例1に係る癒合促進デバイス200の構成について説明する。図8は、変形例1に係る癒合促進デバイス200を示す概略斜視図であって、支持部40が密着部30を支持している状態を示す図である。図9は、図8の状態における変形例1に係る癒合促進デバイス200を示す正面断面図である。図10は、変形例1に係る癒合促進デバイス200を示す概略斜視図であって、支持部40および密着部30が離間した状態を示す図である。図11は、図10の状態における変形例1に係る癒合促進デバイス200を示す正面断面図である。
<Modification example 1>
The configuration of the fusion promoting device 200 according to the first modification will be described with reference to FIGS. 8 to 11. FIG. 8 is a schematic perspective view showing the fusion promoting device 200 according to the first modification, showing a state in which the support portion 40 supports the close contact portion 30. FIG. 9 is a front sectional view showing the fusion promoting device 200 according to the modified example 1 in the state of FIG. FIG. 10 is a schematic perspective view showing the fusion promoting device 200 according to the first modification, showing a state in which the support portion 40 and the close contact portion 30 are separated from each other. FIG. 11 is a front sectional view showing the fusion promoting device 200 according to the modified example 1 in the state of FIG.

変形例1に係る癒合促進デバイス200は、図8〜図11に示すように、接合対象となる生体器官の間に配置される本体部10と、本体部10の内方に設けられる伸縮部20と、接合装置700の第1係合器具710に対して伸縮部20を密着する密着部30と、密着部30の内方部31を支持可能な支持部40と、支持部40および内方部31を接続する接続部50と、を有する。なお、本体部10、伸縮部20、密着部30の構成は、上述した実施形態に係る癒合促進デバイス100と同一の構成であるため、説明は省略する。 As shown in FIGS. 8 to 11, the fusion promoting device 200 according to the first modification has a main body portion 10 arranged between biological organs to be joined and an elastic portion 20 provided inside the main body portion 10. A close contact portion 30 that brings the telescopic portion 20 into close contact with the first engaging device 710 of the joining device 700, a support portion 40 that can support the inner portion 31 of the close contact portion 30, and the support portion 40 and the inner portion. It has a connecting portion 50 for connecting 31 and a connecting portion 50. Since the configuration of the main body portion 10, the telescopic portion 20, and the close contact portion 30 is the same as that of the fusion promoting device 100 according to the above-described embodiment, the description thereof will be omitted.

図9、図11では、内縁補強部13および外縁補強部14の図示は省略する。また、図9では、接続部50の図示は省略する。 In FIGS. 9 and 11, the inner edge reinforcing portion 13 and the outer edge reinforcing portion 14 are not shown. Further, in FIG. 9, the connection portion 50 is not shown.

支持部40は、密着部30の内方部31を拡張状態で、支持可能に構成されている。支持部40は、図8〜図11に示すように、密着部30の内方部31が保持される溝部41と、支持部40の内側に設けられる貫通孔42と、を有する。支持部40の外径は、拡張しない通常状態の密着部30の内方部31の内径(孔部32の外径)よりも小さくなるように構成されている。 The support portion 40 is configured to be able to support the inner portion 31 of the close contact portion 30 in an expanded state. As shown in FIGS. 8 to 11, the support portion 40 has a groove portion 41 in which the inner portion 31 of the close contact portion 30 is held, and a through hole 42 provided inside the support portion 40. The outer diameter of the support portion 40 is configured to be smaller than the inner diameter of the inner portion 31 of the close contact portion 30 in the normal state where it does not expand (the outer diameter of the hole portion 32).

溝部41は、径方向の内方に沿って凹状に設けられる。溝部41は、密着部30の内方部31が好適に嵌まる形状を備えている。 The groove 41 is provided in a concave shape along the inner side in the radial direction. The groove portion 41 has a shape in which the inner portion 31 of the close contact portion 30 is suitably fitted.

貫通孔42の径は、第1係合器具710の被係合部711の外径よりも大きくなるように構成されている。 The diameter of the through hole 42 is configured to be larger than the outer diameter of the engaged portion 711 of the first engaging device 710.

支持部40としては、伸縮部20よりも変形しにくい材料が用いられる。このような材料としては、例えば、プラスチックや金属等を用いることができる。 As the support portion 40, a material that is less likely to be deformed than the telescopic portion 20 is used. As such a material, for example, plastic, metal, or the like can be used.

接続部50は、支持部40および内方部31を接続する。接続部50および支持部40は、例えば接着剤によって固定されている。接続部50および内方部31は、例えば接着剤によって固定されている。 The connecting portion 50 connects the supporting portion 40 and the inner portion 31. The connecting portion 50 and the supporting portion 40 are fixed by, for example, an adhesive. The connecting portion 50 and the inner portion 31 are fixed by, for example, an adhesive.

接続部50は、折り畳み可能に構成されている。接続部50は、図8、図9の状態では、折り畳まれている。また、接続部50は、図10、図11の状態では、折り畳み状態が解除されて、支持部40および内方部31が離間するように構成される。 The connecting portion 50 is configured to be foldable. The connection portion 50 is folded in the state of FIGS. 8 and 9. Further, in the states of FIGS. 10 and 11, the connecting portion 50 is configured such that the folded state is released and the support portion 40 and the inner portion 31 are separated from each other.

接続部50は、周方向に沿って連続するように袋状に構成されている。このように接続部50が袋状に構成されることによって、後述するように、袋状の接続部50によって縫合部A11を包むことができる。このため、癒合促進デバイス200が生体器官から脱落することをより好適に抑制することができる。なお、接続部は、折り畳み可能である構成であれば特に限定されず、例えば紐によって支持部40および内方部31を接続してもよい。 The connecting portion 50 is configured in a bag shape so as to be continuous along the circumferential direction. By forming the connecting portion 50 in a bag shape in this way, the suture portion A11 can be wrapped by the bag-shaped connecting portion 50 as described later. Therefore, it is possible to more preferably suppress the fusion promoting device 200 from falling off from the living organ. The connecting portion is not particularly limited as long as it has a foldable configuration, and the support portion 40 and the inner portion 31 may be connected by, for example, a string.

<変形例1に係る癒合促進デバイスの処置方法>
次に変形例1に係る癒合促進デバイス200の処置方法について説明する。変形例1に係る癒合促進デバイス200の処置方法は、上述した実施形態に係る癒合促進デバイス100の処置方法に対して、大腸の口部周辺と大腸の腸壁の間に癒合促進デバイス200を配置した後の工程において異なるため、大腸の口部周辺と大腸の腸壁の間に癒合促進デバイス200を配置した後の工程について説明する。
<Treatment method of fusion promoting device according to Modification 1>
Next, a treatment method for the fusion promoting device 200 according to the first modification will be described. In the treatment method of the fusion promoting device 200 according to the first modification, the fusion promoting device 200 is arranged between the mouth of the large intestine and the intestinal wall of the large intestine with respect to the treatment method of the fusion promoting device 100 according to the above-described embodiment. Since the steps after the above are different, the steps after arranging the fusion promoting device 200 between the mouth of the large intestine and the intestinal wall of the large intestine will be described.

大腸の口側A1と大腸の肛門側A2との間に癒合促進デバイス200を配置した後、癒合促進デバイス200に第1係合器具710の被係合部711を挿通したとき、縫合部A11が支持部40に接触する。これによって、内方部31を拡張状態で支持している(図9参照)支持部40は、本体部10の面方向と交差する交差方向(図9、図11の上方向)に移動して(図11参照)、支持部40の内方部31に対する支持状態が解除されて、支持部40および密着部30が交差方向に沿って離間する。このとき、密着部30は支持部40において支持されていたときよりも少ない拡張状態で、第1係合器具710の被係合部711に支持される。 After arranging the fusion promoting device 200 between the oral side A1 of the large intestine and the anal side A2 of the large intestine, when the engaged portion 711 of the first engaging device 710 is inserted into the fusion promoting device 200, the sutured portion A11 is inserted. Contact the support portion 40. As a result, the support portion 40 that supports the inner portion 31 in the expanded state (see FIG. 9) moves in the intersecting direction (upward in FIGS. 9 and 11) that intersects the surface direction of the main body portion 10. (See FIG. 11), the support state of the support portion 40 with respect to the inner portion 31 is released, and the support portion 40 and the close contact portion 30 are separated from each other along the intersecting direction. At this time, the close contact portion 30 is supported by the engaged portion 711 of the first engaging device 710 in a less expanded state than when it was supported by the support portion 40.

このとき、支持部40および内方部31が接続部50によって接続されるため、支持部40が意図せず内方部31から離れてしまうことを好適に防止することができる。また、袋状の接続部50によって縫合部A11を包むことができる。このため、癒合促進デバイス200が生体器官から脱落することをより好適に抑制することができる。 At this time, since the support portion 40 and the inner portion 31 are connected by the connecting portion 50, it is possible to preferably prevent the support portion 40 from being unintentionally separated from the inner portion 31. Further, the sutured portion A11 can be wrapped by the bag-shaped connecting portion 50. Therefore, it is possible to more preferably suppress the fusion promoting device 200 from falling off from the living organ.

以上説明したように、変形例1に係る癒合促進デバイス200は、第1係合器具710の被係合部711が挿通可能に構成されるとともに、内方部31を拡張状態で支持可能な支持部40と、支持部40および内方部31を接続するとともに、折り畳み可能に構成された接続部50と、をさらに有する。内方部31を拡張状態で支持している支持部40が、本体部10の面方向と交差する交差方向に移動した際、支持部40の内方部31に対する支持状態が解除され、支持部40および密着部30が、交差方向に沿って離間する。このように構成された癒合促進デバイス200によれば、癒合促進デバイス200が生体器官から脱落することをより好適に抑制することができる。 As described above, in the fusion promoting device 200 according to the first modification, the engaged portion 711 of the first engaging device 710 is configured to be insertable, and the inner portion 31 can be supported in an expanded state. The portion 40 is connected to the support portion 40 and the inner portion 31, and further includes a foldable connecting portion 50. When the support portion 40 supporting the inner portion 31 in the expanded state moves in the intersecting direction intersecting the surface direction of the main body portion 10, the support state of the support portion 40 with respect to the inner portion 31 is released, and the support portion is released. The 40 and the close contact portion 30 are separated from each other along the intersecting direction. According to the fusion promoting device 200 configured in this way, it is possible to more preferably suppress the fusion promoting device 200 from falling off from the living organ.

<変形例2>
次に、図12、図13を参照して、変形例2に係る癒合促進デバイス300の構成について説明する。図12は、変形例2に係る癒合促進デバイス300を示す正面断面図であって、支持部40が密着部330を支持している状態を示す図である。図13は、変形例2に係る癒合促進デバイス300を示す正面断面図であって、支持部40および密着部330が離間した状態を示す図である。
<Modification 2>
Next, the configuration of the fusion promoting device 300 according to the second modification will be described with reference to FIGS. 12 and 13. FIG. 12 is a front sectional view showing the fusion promoting device 300 according to the second modification, showing a state in which the supporting portion 40 supports the close contact portion 330. FIG. 13 is a front sectional view showing the fusion promoting device 300 according to the second modification, showing a state in which the support portion 40 and the close contact portion 330 are separated from each other.

変形例2に係る癒合促進デバイス300は、図12、図13に示すように、接合対象となる生体器官の間に配置される本体部10と、本体部10の内方に設けられる伸縮部320と、接合装置700の第1係合器具710に対して伸縮部320を密着する密着部330と、密着部330を支持可能な支持部40と、を有する。なお、本体部10、支持部40の構成は、上述した実施形態に係る癒合促進デバイス100または変形例1に係る癒合促進デバイス200と同一の構成であるため、説明は省略する。 As shown in FIGS. 12 and 13, the fusion promoting device 300 according to the second modification has a main body portion 10 arranged between the biological organs to be joined and an elastic portion 320 provided inside the main body portion 10. A close contact portion 330 that brings the telescopic portion 320 into close contact with the first engaging device 710 of the joining device 700, and a support portion 40 that can support the close contact portion 330. Since the configuration of the main body portion 10 and the support portion 40 is the same as that of the fusion promoting device 100 according to the above-described embodiment or the fusion promoting device 200 according to the first modification, the description thereof will be omitted.

伸縮部320は、図12、図13に示すように、本体部10の内方に位置する基部321と、基部321から交差方向(図12、図13の上下方向)に延在する延在部322と、を有する。伸縮部320の延在部322は、上述した変形例1に係る癒合促進デバイス200の接続部50の機能を果たしている。 As shown in FIGS. 12 and 13, the telescopic portion 320 has a base portion 321 located inward of the main body portion 10 and an extending portion extending in an intersecting direction (vertical direction in FIGS. 12 and 13) from the base portion 321. 322 and. The extending portion 322 of the telescopic portion 320 fulfills the function of the connecting portion 50 of the fusion promoting device 200 according to the above-mentioned modification 1.

密着部330は、図12、図13に示すように、リング状に構成されている。密着部330は、図12、図13に示すように、基部321および延在部322の境界に位置する境界部323の外方に配置される。 As shown in FIGS. 12 and 13, the close contact portion 330 is formed in a ring shape. As shown in FIGS. 12 and 13, the close contact portion 330 is arranged outside the boundary portion 323 located at the boundary between the base portion 321 and the extending portion 322.

<変形例2に係る癒合促進デバイスの処置方法>
次に変形例2に係る癒合促進デバイス300の処置方法について説明する。変形例2に係る癒合促進デバイス300の処置方法は、上述した実施形態に係る癒合促進デバイス100の処置方法に対して、大腸の口部周辺と大腸の腸壁の間に癒合促進デバイス300を配置した後の工程において異なるため、大腸の口部周辺と大腸の腸壁の間に癒合促進デバイス300を配置した後の工程について説明する。
<Treatment method of fusion promoting device according to Modification 2>
Next, a treatment method for the fusion promoting device 300 according to the second modification will be described. In the treatment method of the fusion promoting device 300 according to the second modification, the fusion promoting device 300 is arranged between the mouth of the large intestine and the intestinal wall of the large intestine with respect to the treatment method of the fusion promoting device 100 according to the above-described embodiment. Since the steps after the process are different, the process after arranging the fusion promoting device 300 between the mouth of the large intestine and the intestinal wall of the large intestine will be described.

大腸の口側A1と大腸の肛門側A2との間に癒合促進デバイス300を配置した後、癒合促進デバイス300に第1係合器具710の被係合部711を挿通したとき、縫合部A11が支持部40に接触する。これによって、密着部330を拡張状態で支持している支持部40が、交差方向に移動した際、支持部40の密着部330に対する支持状態が解除され、支持部40および密着部330が、交差方向に沿って離間する。 After arranging the fusion promoting device 300 between the oral side A1 of the large intestine and the anal side A2 of the large intestine, when the engaged portion 711 of the first engaging device 710 is inserted into the fusion promoting device 300, the sutured portion A11 becomes Contact the support portion 40. As a result, when the support portion 40 supporting the close contact portion 330 in the expanded state moves in the crossing direction, the support state of the support portion 40 with respect to the close contact portion 330 is released, and the support portion 40 and the close contact portion 330 intersect. Separate along the direction.

以上説明したように、変形例2に係る癒合促進デバイス300は、第1係合器具710の被係合部711が挿通可能に構成されるとともに、リング状に構成される密着部330を拡張状態で支持可能な支持部40をさらに有する。また、伸縮部320は、本体部10の内方に位置する基部321と、基部321から本体部10の面方向と交差する交差方向に延在する延在部322と、を有する。また、密着部330は、基部321および延在部322の境界部323の外方に配置される。また、密着部330を拡張状態で支持している支持部40が、交差方向に移動した際、支持部40の密着部330に対する支持状態が解除され、支持部40および密着部330が、交差方向に沿って離間する。 As described above, in the fusion promoting device 300 according to the second modification, the engaged portion 711 of the first engaging device 710 is configured to be insertable, and the contact portion 330 formed in a ring shape is expanded. It further has a support portion 40 that can be supported by. Further, the telescopic portion 320 has a base portion 321 located inside the main body portion 10 and an extending portion 322 extending from the base portion 321 in the intersecting direction intersecting the surface direction of the main body portion 10. Further, the close contact portion 330 is arranged outside the boundary portion 323 of the base portion 321 and the extending portion 322. Further, when the support portion 40 supporting the close contact portion 330 in the expanded state moves in the crossing direction, the support state of the support portion 40 with respect to the close contact portion 330 is released, and the support portion 40 and the close contact portion 330 are in the crossing direction. Separate along.

このように構成された癒合促進デバイス300によれば、癒合促進デバイス300が生体器官から脱落することをより好適に抑制することができる。また、伸縮部320が変形例1に係る癒合促進デバイス200の接続部50の機能も果たすため、変形例1に係る癒合促進デバイス200よりも少ない構成要素で、癒合促進デバイス300が生体器官から脱落することを抑制することができる。 According to the fusion promoting device 300 configured in this way, it is possible to more preferably suppress the fusion promoting device 300 from falling off from the living organ. Further, since the expansion / contraction portion 320 also functions as the connection portion 50 of the fusion promoting device 200 according to the modification 1, the fusion promotion device 300 is detached from the biological organ with fewer components than the fusion promotion device 200 according to the modification 1. Can be suppressed.

10 本体部、
13 内縁補強部、
14 外縁補強部、
20、320 伸縮部、
30、330 密着部、
31 内方部、
32 孔部、
40 支持部、
50 接続部、
321 基部、
322 延在部、
323 境界部、
700 接合装置、
710 第1係合器具、
711 被係合部(シャフト)、
720 第2係合器具、
A1 口側、
A11 縫合部、
A2 肛門側、
A21 貫通孔。
10 Main body,
13 Inner edge reinforcement,
14 Outer edge reinforcement,
20, 320 telescopic part,
30, 330 Adhesion,
31 Inner part,
32 holes,
40 Support,
50 connections,
321 base,
322 Extension,
323 Boundary,
700 joining equipment,
710 First Engagement Device,
711 Engaged part (shaft),
720 Second Engagement Device,
A1 mouth side,
A11 sutured part,
A2 anal side,
A21 through hole.

Claims (8)

接合対象となる生体器官の間に配置され、生体組織の癒合を促進する本体部と、
前記本体部の内方に設けられ、前記本体部よりも伸縮性の高い伸縮部と、
前記生体器官を接合する手技に用いる医療器具の少なくとも一部が挿通可能に構成され、前記医療器具が挿通された状態において、前記医療器具の外周部の少なくとも一部に対して前記伸縮部を密着させる密着部と、を有する癒合促進デバイス。
The main body, which is placed between the biological organs to be joined and promotes the fusion of biological tissues,
An elastic portion provided inside the main body portion and having higher elasticity than the main body portion,
At least a part of the medical device used for the procedure of joining the biological organs is configured to be insertable, and in the state where the medical device is inserted, the telescopic part is brought into close contact with at least a part of the outer peripheral portion of the medical device. A fusion-promoting device that has a close contact, and
前記医療器具は、前記生体器官の一方の被接合部位に配置される第1係合器具と、前記生体器官の他方の被接合部位に配置され、前記第1係合器具と対向する第2係合器具とを備えた接合装置であって、
前記密着部は、前記第1係合器具のシャフトが挿通可能に構成され、前記シャフトが挿通された状態において、前記シャフトに対して前記伸縮部を密着させる、請求項1に記載の癒合促進デバイス。
The medical device has a first engaging device arranged at one of the joined parts of the living organ and a second engaging device placed at the other joined part of the living organ and facing the first engaging device. It is a joining device equipped with a combination tool,
The fusion promoting device according to claim 1, wherein the close contact portion is configured so that the shaft of the first engaging device can be inserted, and the telescopic portion is brought into close contact with the shaft in a state where the shaft is inserted. ..
前記密着部は、
前記伸縮部のうち内方に位置する内方部と、
前記伸縮部の内方に位置する孔部と、を有する、請求項1または2に記載の癒合促進デバイス。
The close contact portion is
The inner part of the telescopic part located inward and
The fusion promoting device according to claim 1 or 2, further comprising a hole located inside the telescopic portion.
前記医療器具が挿通可能に構成されるとともに、前記内方部を拡張状態で支持可能な支持部と、
前記支持部および前記内方部を接続するとともに、折り畳み可能に構成された接続部と、をさらに有し、
前記内方部を拡張状態で支持している前記支持部が、前記本体部の面方向と交差する交差方向に移動した際、前記支持部の前記内方部に対する支持状態が解除され、前記支持部および前記密着部が、前記交差方向に沿って離間する、請求項3に記載の癒合促進デバイス。
A support portion that is configured to allow the medical device to be inserted and that can support the inner portion in an expanded state, and a support portion that can support the inner portion in an expanded state.
In addition to connecting the support portion and the inner portion, the support portion and the foldable connection portion are further provided.
When the support portion supporting the inner portion in the expanded state moves in an intersecting direction intersecting the surface direction of the main body portion, the support state of the support portion with respect to the inner portion is released, and the support The fusion promoting device according to claim 3, wherein the portion and the close contact portion are separated from each other along the crossing direction.
前記医療器具が挿通可能に構成されるとともに、リング状に構成される前記密着部を拡張状態で支持可能な支持部をさらに有し、
前記伸縮部は、前記本体部の内方に位置する基部と、前記基部から前記本体部の面方向と交差する交差方向に延在する延在部と、を有し、
前記密着部は、前記基部および前記延在部の境界部の外方に配置され、
前記密着部を拡張状態で支持している前記支持部が、前記交差方向に移動した際、前記支持部の前記密着部に対する支持状態が解除され、前記支持部および前記密着部が、前記交差方向に沿って離間する、請求項1または2に記載の癒合促進デバイス。
The medical device is configured to be insertable, and further has a support portion capable of supporting the close contact portion formed in a ring shape in an expanded state.
The telescopic portion has a base portion located inward of the main body portion and an extending portion extending from the base portion in an intersecting direction intersecting the surface direction of the main body portion.
The close contact portion is arranged outside the boundary portion between the base portion and the extending portion.
When the support portion supporting the close contact portion in the expanded state moves in the crossing direction, the support state of the support portion with respect to the close contact portion is released, and the support portion and the close contact portion are in the crossing direction. The fusion promoting device according to claim 1 or 2, which is separated from the device.
前記伸縮部および前記密着部は、第1係合器具と第2係合器具によって前記本体部を前記生体組織に接合する際に、前記第1係合器具と前記第2係合器具とが、前記本体部を間に挟んで対向して重なる領域よりも内方側に位置する、請求項2〜5のいずれか1項に記載の癒合促進デバイス。 When the main body portion is joined to the living tissue by the first engaging device and the second engaging device, the telescopic portion and the close contact portion are formed by the first engaging device and the second engaging device. The fusion promoting device according to any one of claims 2 to 5, which is located on the inner side of an area where the main body portion is sandwiched between them and overlaps with each other. 前記本体部は、前記本体部の内縁に沿って配置され前記本体部を補強する内縁補強部を有する、請求項1〜6のいずれか1項に記載の癒合促進デバイス。 The fusion promoting device according to any one of claims 1 to 6, wherein the main body portion has an inner edge reinforcing portion that is arranged along the inner edge of the main body portion and reinforces the main body portion. 前記本体部は、前記本体部の外縁に沿って配置され前記本体部を補強する外縁補強部を有する、請求項1〜7のいずれか1項に記載の癒合促進デバイス。 The fusion promoting device according to any one of claims 1 to 7, wherein the main body portion has an outer edge reinforcing portion that is arranged along the outer edge of the main body portion and reinforces the main body portion.
JP2019174452A 2019-09-25 2019-09-25 Concrescence acceleration device Pending JP2021049191A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023032693A1 (en) * 2021-09-03 2023-03-09 テルモ株式会社 Medical member
WO2023047966A1 (en) * 2021-09-27 2023-03-30 テルモ株式会社 Medical device
WO2025070084A1 (en) * 2023-09-27 2025-04-03 テルモ株式会社 Medical sheet and method for producing medical sheet

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023032693A1 (en) * 2021-09-03 2023-03-09 テルモ株式会社 Medical member
WO2023047966A1 (en) * 2021-09-27 2023-03-30 テルモ株式会社 Medical device
EP4393414A4 (en) * 2021-09-27 2024-11-06 TERUMO Kabushiki Kaisha MEDICAL DEVICE
WO2025070084A1 (en) * 2023-09-27 2025-04-03 テルモ株式会社 Medical sheet and method for producing medical sheet

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