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WO2015182737A1 - Living body pressing clip - Google Patents

Living body pressing clip Download PDF

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Publication number
WO2015182737A1
WO2015182737A1 PCT/JP2015/065513 JP2015065513W WO2015182737A1 WO 2015182737 A1 WO2015182737 A1 WO 2015182737A1 JP 2015065513 W JP2015065513 W JP 2015065513W WO 2015182737 A1 WO2015182737 A1 WO 2015182737A1
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Prior art keywords
clip
cylindrical member
living body
compression clip
compression
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PCT/JP2015/065513
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French (fr)
Japanese (ja)
Inventor
佐藤　隆幸
宮坂　進
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国立大学法人 高知大学
日本コヴィディエン株式会社
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Priority to JP2016523570A priority Critical patent/JP6161096B2/en
Publication of WO2015182737A1 publication Critical patent/WO2015182737A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges

Definitions

  • a surgical marker comprising a clip that locks on a mucous membrane in the body and a light emitting body formed of an LED or a fluorescent material that emits near infrared light, which is placed in the vicinity of the clip, is proposed.
  • Patent Document 1 a surgical marker comprising a clip that locks on a mucous membrane in the body and a light emitting body formed of an LED or a fluorescent material that emits near infrared light, which is placed in the vicinity of the clip.
  • FIG. 1 is a perspective view of a clip body and a cylindrical member that constitute a living body compression clip 1A of an embodiment.
  • FIG. 2A is a perspective view of the living body compression clip 1A of the embodiment.
  • FIG. 2B is a perspective view of the living body compression clip 1A of the embodiment.
  • FIG. 2C is a perspective view of the living body compression clip 1A of the embodiment.
  • FIG. 3A is an explanatory diagram of a method of using the living body compression clip 1A.
  • FIG. 3B is an explanatory diagram of a method of using the living body compression clip 1A.
  • FIG. 3C is an explanatory diagram of a method of using the living body compression clip 1A.
  • FIG. 3D is an explanatory diagram of a method of using the living body compression clip 1A.
  • FIG. 3E is an explanatory diagram of the action by the compression of the mucous membrane 40, and is an enlarged view of the compressed portion and the region P in the vicinity thereof.
  • the living body compression clip of the present invention can take various forms.
  • a living body compression clip 1B shown in FIG. 4A is obtained by attaching a metal ring 29 made of stainless steel or the like to the tubular member 20 in the above-described living body compression clip 1A.
  • a metal ring 29 made of stainless steel or the like is attached to the tubular member 20 in the above-described living body compression clip 1A.
  • the durability of the cylindrical member 20 that tightens the clip body 10 can be improved, and a reduction in the force with which the clip body 10 holds the mucous membrane 40 can be prevented.
  • FIG. 8 is a perspective view of the clip body 10 and the cylindrical member 20 constituting the living body compression clip 1E of another embodiment of the present invention.
  • the living body compression clip 1E has a bottomed cylindrical shape in which the tubular member 20 has a bottom 24 at one end, and the bottom 24 acts as a pressing portion.
  • the peripheral wall of the cylindrical member 20 has a pair of slits 25 that extend to the bottom 24 in the axial direction of the cylindrical member 20, and the bottom 24 is also partially cut away.
  • the width L5 of the slit 25 is a length that allows the arm portion 11 to pass through the holding portion 12 side.
  • the living body compression clip 1E is configured in the same manner as the living body compression clip 1A described above except for the shape of the cylindrical member 20.
  • the clip body 10 obtained by removing the fastening ring from a commercially available clip device having a clip body having the same shape as the clip body 10 of the biological compression clip shown in FIG. 1 is used as the above-described cylindrical member. 20 was attached, and the living body compression clip of Example 1 was obtained.
  • a fiber light source capable of irradiating both white illumination light having a wavelength of 400 nm to 650 nm and excitation light having a wavelength of 680 nm to 780 nm, or only white illumination light is connected to the light guide connection portion of the rapaloscope.
  • the serosal surface was irradiated with white illumination light and excitation light, and when only the white illumination light was irradiated, the serosal surface was observed with a laparoscope.
  • the intensity of the white illumination light was 1000 lux for the subject illumination
  • the intensity of the excitation light was 30 mW / cm 2 .
  • the near-infrared fluorescence emitted from the fluorescent dye blended in the resin tube was assigned green as the video display color.
  • FIGS. 17A, 17B, 18A, and 18B The results are shown in FIGS. 17A, 17B, 18A, and 18B.
  • 17A is an image obtained by irradiating only the serosal surface of the site where the living body compression clip of Example 1 was anchored with white illumination light and photographing the serosal surface
  • FIG. 17B shows the same serosal surface with white illumination. It is the image which imaged the serosal surface by irradiating light and excitation light simultaneously. Note that when this image is displayed in gray scale, the green light assigned to the fluorescence emitted from the fluorescent dye and the surface reflected light cannot be distinguished on the image, so in FIG. 17B, the brightness of the green light is displayed as zero. did.
  • FIG. 17A is an image obtained by irradiating only the serosal surface of the site where the living body compression clip of Example 1 was anchored with white illumination light and photographing the serosal surface
  • FIG. 17B shows the same serosal surface with white illumination. It is the
  • FIG. 18A is an image obtained by irradiating only the serosal surface of the site where the clip of Comparative Example 1 is anchored with white illumination light and photographing the serosal surface
  • FIG. 18B is an image of white illumination light and excitation on the same serosal surface. It is the image which imaged the serosal surface by irradiating light simultaneously.
  • the black circle represents the position of the mucosal surface where the clip of Comparative Example 1 was anchored.
  • fluorescence emitted from the fluorescent dye cannot be recognized.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pathology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Reproductive Health (AREA)
  • Vascular Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

A living body pressing clip (1A) comprises a clip body (10) and a cylindrical member (20) that is slidably attached to the clip body (10) and fastens the clip body (10). The clip body (10) is provided with arm parts (11) that hold a mucosal tissue in a luminal organ when fastened by the cylindrical member (20). The cylindrical member (20) is provided with a pressing part (22) that presses the mucosa in a direction of thinning the thickness (D) of the mucosa in the state where the cylindrical member (20) fastens the clip body (10) so that the clip body (10) holds the mucosal tissue in the luminal organ. The pressing part (22) contains a fluorescent dye capable of emitting a red or near-infrared light when irradiated with an exciting light. By using this living body pressing clip (1A), a light-emitting site of a light-emitting marker attached to a mucosal tissue in a luminal organ can be confirmed with a good visibility, even in the case of observing from outside the luminal organ.

Description

生体圧迫クリップBiological compression clip
　本発明は、管腔臓器の内部のマーカーとして有用なクリップに関する。 The present invention relates to a clip useful as a marker inside a luminal organ.
　一般に、食道、胃、大腸等の消化管の癌等の疾患は、主として消化管の粘膜から発生し進行する。同様に、肺癌は、主として気管粘膜から発生し、膀胱癌は、主として膀胱粘膜から発生し進行する。そのため、消化管、気管、膀胱等の管腔臓器の疾患の診断を確定させるには、内視鏡を管腔臓器内に挿入して粘膜を観察し、患部組織を生検することが必須となっている。そして、その確定診断に基づき、患部組織は必要に応じて外科的に切除される。 In general, diseases such as cancer of the digestive tract such as the esophagus, stomach, and large intestine mainly occur from the mucous membrane of the digestive tract and progress. Similarly, lung cancer arises primarily from the tracheal mucosa, and bladder cancer arises and progresses primarily from the bladder mucosa. Therefore, in order to confirm the diagnosis of diseases of luminal organs such as the digestive tract, trachea, and bladder, it is essential to insert an endoscope into the luminal organ, observe the mucosa, and biopsy the affected tissue. It has become. Based on the confirmed diagnosis, the affected tissue is surgically removed as necessary.
　しかしながら、外科的切除術において、外科医は管腔臓器の外側からアプローチするため、患部を直接的に視認することはできない。即ち、開胸又は開腹を行い、肉眼で消化管、肺又は膀胱を観察した場合、見えるのは、消化管漿膜面、気管漿膜面、膀胱腹膜面であり、粘膜面ではない。そのため、管腔臓器の外側から観察した場合でも切除域を確定できるように、管腔臓器の内部にマーカーを取り付けることが有用となる。 However, in the surgical resection, the surgeon approaches from the outside of the luminal organ, so the affected part cannot be directly seen. That is, when thoracotomy or laparotomy is performed and the digestive tract, lungs or bladder are observed with the naked eye, the gastrointestinal serosal surface, tracheal serosal surface, and bladder peritoneal surface are visible, not the mucosal surface. Therefore, it is useful to attach a marker inside the luminal organ so that the excision area can be determined even when observed from outside the luminal organ.
　このようなマーカーとして、体内の粘膜に係止するクリップと、クリップに近接して留置される、近赤外光を発するＬＥＤ又は蛍光発光物質で形成された発光体からなる外科手術用マーカーが提案されている（特許文献１）。 As such a marker, a surgical marker comprising a clip that locks on a mucous membrane in the body and a light emitting body formed of an LED or a fluorescent material that emits near infrared light, which is placed in the vicinity of the clip, is proposed. (Patent Document 1).
特開２００５－２１８６８０JP 2005-218680 A
　しかしながら、上述の外科手術用マーカーにおいて、発光体としてＬＥＤを使用したマーカーは電源の供給を必要とするので装置構成が複雑となる。また、内視鏡用生検口に通すことができるように、マーカーをコンパクトに形成することが困難である。 However, in the above-described surgical marker, a marker using an LED as a light emitter requires a power supply, and thus the apparatus configuration is complicated. In addition, it is difficult to form the marker in a compact manner so that the marker can be passed through the endoscope biopsy port.
　一方、上述の外科手術用マーカーにおいて、蛍光発光物質で形成された発光体を使用するものは、管腔臓器の外側から励起光を照射することにより蛍光を発光するとされており、蛍光を発光させるための電源の供給が不要となっているが、管腔臓器の外側（漿膜側）に出射する蛍光の強度が弱く、実際上、管腔臓器の外側から発光部位を視認することはできない。 On the other hand, in the above-mentioned surgical markers, those using a luminescent material formed of a fluorescent luminescent substance are said to emit fluorescence by irradiating excitation light from the outside of the luminal organ, and emit fluorescence. However, the intensity of the fluorescence emitted to the outside (serosa side) of the luminal organ is weak, and the luminescent site cannot actually be visually recognized from the outside of the luminal organ.
　これに対し、本発明が解決しようとする課題は、蛍光発光物質を用いて形成されたマーカーに関し、管腔臓器の粘膜に取り付けたマーカーの発光を、管腔臓器の外側から観察した場合でも、発光部位を良好に視認できるようにすることにある。 On the other hand, the problem to be solved by the present invention relates to a marker formed using a fluorescent substance, even when the luminescence of the marker attached to the mucosa of the luminal organ is observed from the outside of the luminal organ, The object is to make it possible to visually recognize the light emitting part.
　本発明者は、蛍光発光物質を用いて形成されたマーカーに関して、次の知見を得た。
　蛍光発光物質を用いて形成された従来のマーカーを管腔臓器の粘膜に取り付け、それを管腔臓器の外側（漿膜側）から観察した場合に、マーカーの発光部位を視認することができないのは、粘膜下層にある血管網の血液に含まれる酸化型及び還元型のヘモグロビンの存在に起因すること、
即ち、(i)管腔臓器の粘膜下層では動脈及び静脈の血管網が発達しており、血管網の血液に含まれるヘモグロビンが赤色乃至近赤外光を吸収しやすいこと、
(ii)赤色乃至近赤外光領域に吸収ピークを有する蛍光発光物質に蛍光を発せさせる励起光の波長は、蛍光よりも短波長の赤色乃至近赤外光となるが、そのような励起光を管腔臓器の外側（漿膜側）から内側（粘膜側）に向けて照射しても、その多くは粘膜下層の血管網の血液に含まれるヘモグロビンに吸収されてしまうので、管腔臓器の粘膜に設けた蛍光発光物質には励起光が到達しにくいこと、
(iii)蛍光発光物質が励起光を吸収できたとしても、それにより発せられる蛍光も粘膜下層の血管網の血液に含まれるヘモグロビンに吸収されるため、管腔臓器の外側に出射する蛍光の強度は極めて低くなること、
を見出した。 The inventor of the present invention has obtained the following knowledge regarding a marker formed using a fluorescent substance.
When a conventional marker formed using a fluorescent material is attached to the mucous membrane of a luminal organ and observed from the outside (serosa side) of the luminal organ, the luminescent site of the marker cannot be visually recognized. Due to the presence of oxidized and reduced hemoglobin in the blood of the vascular network in the submucosa,
That is, (i) the vascular network of arteries and veins has developed in the submucosal layer of the luminal organ, and hemoglobin contained in the blood of the vascular network is easy to absorb red to near infrared light,
(ii) The wavelength of the excitation light that causes the fluorescent light-emitting substance having an absorption peak in the red to near-infrared light region to emit fluorescence is red to near-infrared light having a shorter wavelength than the fluorescence. Is irradiated from the outer side (serosa side) to the inner side (mucosal side) of the luminal organ, most of which is absorbed by hemoglobin contained in the blood of the vascular network in the submucosal layer. The excitation light is difficult to reach the fluorescent material
(iii) Even if the fluorescent light-emitting substance can absorb the excitation light, the fluorescence emitted by the fluorescent light-emitting substance is also absorbed by hemoglobin contained in the blood of the submucosal vascular network, so that the intensity of the fluorescence emitted outside the luminal organ Is extremely low,
I found.
　そして、このようなヘモグロビンによる励起光及び蛍光の吸収を抑制するには、蛍光を発光する発光体を粘膜に、該粘膜の厚さが薄くなる方向に押し付けて粘膜を圧迫し、粘膜下層の血管網を圧縮することにより血管から血液を排除し、それにより酸化型及び還元型のヘモグロビンを排除することが有効であることを見出し、本発明を想到した。 In order to suppress the absorption of excitation light and fluorescence by such hemoglobin, a fluorescent substance that emits fluorescence is pressed against the mucous membrane to press the mucous membrane in a direction in which the thickness of the mucous membrane becomes thinner, thereby compressing the blood vessels in the submucosa. The inventors have found that it is effective to eliminate blood from blood vessels by compressing the net, thereby eliminating oxidized and reduced hemoglobin.
　即ち、本発明は、クリップ本体、及びクリップ本体に摺動可能に取り付けられ、クリップ本体に締着する筒状部材を備えた生体圧迫クリップであって、
クリップ本体は筒状部材の締着により管腔臓器の粘膜組織を挟持するアーム部を有し、筒状部材は、該筒状部材のクリップ本体への締着によりクリップ本体が管腔臓器の粘膜組織を挟持している状態で、粘膜の厚さを薄くする方向に粘膜を圧迫する押圧部を有し、該押圧部が、励起光の照射により赤色乃至近赤外光を発光する蛍光色素を有する生体圧迫クリップを提供する。 That is, the present invention is a biological compression clip comprising a clip body and a cylindrical member that is slidably attached to the clip body and fastened to the clip body,
The clip main body has an arm portion that clamps the mucosal tissue of the luminal organ by fastening the cylindrical member, and the cylindrical member is attached to the clip main body of the tubular member by the clip main body. A pressing part that presses the mucous membrane in the direction of decreasing the thickness of the mucous membrane while sandwiching the tissue, and the pressing part emits a fluorescent dye that emits red to near-infrared light when irradiated with excitation light. A living body compression clip is provided.
　本発明の生体圧迫クリップによれば、クリップ本体が管腔臓器の粘膜組織を挟持した状態で、押圧部が粘膜を、該粘膜の厚さを薄くする方向に圧迫するので、圧迫された部分では粘膜下層の動脈及び静脈の血管網の血管が圧縮し、血管から血液が排除され、それによりヘモグロビンも排除される。
　この押圧部は、励起光の照射により赤色乃至近赤外光を発光する蛍光色素を有している。 According to the living body compression clip of the present invention, in the state where the clip body sandwiches the mucosal tissue of the luminal organ, the pressing part compresses the mucous membrane in the direction of reducing the thickness of the mucosa. The blood vessels in the submucosal arterial and venous vascular networks are compressed, removing blood from the blood vessels, and thereby hemoglobin.
The pressing portion has a fluorescent dye that emits red to near-infrared light when irradiated with excitation light.
　したがって、管腔臓器の外側から照射された励起光は、ヘモグロビンでほとんど吸収されることなく、押圧部の蛍光色素に効率よく吸収され、それにより押圧部の蛍光色素から発せられる蛍光も、ヘモグロビンでほとんど吸収されることなく管腔臓器の外側に出射する。よって、管腔臓器の粘膜に取り付けた生体圧迫クリップの発光を、管腔臓器の外側から良好に視認することが可能となる。 Therefore, the excitation light emitted from the outside of the luminal organ is hardly absorbed by hemoglobin, but is efficiently absorbed by the fluorescent dye in the pressing part, and the fluorescence emitted from the fluorescent dye in the pressing part is also absorbed by hemoglobin. It is emitted outside the luminal organ with little absorption. Therefore, the light emitted from the living body compression clip attached to the mucosa of the luminal organ can be visually recognized from the outside of the luminal organ.
図１は、実施例の生体圧迫クリップ１Ａを構成するクリップ本体と筒状部材の斜視図である。FIG. 1 is a perspective view of a clip body and a cylindrical member that constitute a living body compression clip 1A of an embodiment. 図２Ａは、実施例の生体圧迫クリップ１Ａの斜視図である。FIG. 2A is a perspective view of the living body compression clip 1A of the embodiment. 図２Ｂは、実施例の生体圧迫クリップ１Ａの斜視図である。FIG. 2B is a perspective view of the living body compression clip 1A of the embodiment. 図２Ｃは、実施例の生体圧迫クリップ１Ａの斜視図である。FIG. 2C is a perspective view of the living body compression clip 1A of the embodiment. 図３Ａは、生体圧迫クリップ１Ａの使用方法の説明図である。FIG. 3A is an explanatory diagram of a method of using the living body compression clip 1A. 図３Ｂは、生体圧迫クリップ１Ａの使用方法の説明図である。FIG. 3B is an explanatory diagram of a method of using the living body compression clip 1A. 図３Ｃは、生体圧迫クリップ１Ａの使用方法の説明図である。FIG. 3C is an explanatory diagram of a method of using the living body compression clip 1A. 図３Ｄは、生体圧迫クリップ１Ａの使用方法の説明図である。FIG. 3D is an explanatory diagram of a method of using the living body compression clip 1A. 図３Ｅは、生体圧迫クリップ１Ａの作用の説明図である。FIG. 3E is an explanatory diagram of the action of the living body compression clip 1A. 図４Ａは、生体圧迫クリップ１Ａ’の斜視図である。FIG. 4A is a perspective view of the living body compression clip 1A ′. 図４Ｂは、生体圧迫クリップ１Ａ’を粘膜に取り付けた状態の斜視図及び断面図である。FIG. 4B is a perspective view and a cross-sectional view of a state in which the living body compression clip 1A ′ is attached to the mucous membrane. 図５Ａは、生体圧迫クリップ１Ｂの斜視図である。FIG. 5A is a perspective view of the living body compression clip 1B. 図５Ｂは、生体圧迫クリップ１Ｂを粘膜に取り付けた状態の斜視図及び断面図である。FIG. 5B is a perspective view and a cross-sectional view of a state in which the living body compression clip 1B is attached to the mucous membrane. 図６Ａは、生体圧迫クリップ１Ｃの斜視図である。FIG. 6A is a perspective view of the living body compression clip 1C. 図６Ｂは、生体圧迫クリップ１Ｃを粘膜に取り付けた状態の斜視図及び断面図である。FIG. 6B is a perspective view and a cross-sectional view of a state in which the biological compression clip 1C is attached to the mucous membrane. 図７Ａは、生体圧迫クリップ１Ｄの斜視図である。FIG. 7A is a perspective view of the living body compression clip 1D. 図７Ｂは、生体圧迫クリップ１Ｄを粘膜に取り付けた状態の斜視図及び断面図である。FIG. 7B is a perspective view and a cross-sectional view of a state in which the living body compression clip 1D is attached to the mucous membrane. 図８は、生体圧迫クリップ１Ｅを構成するクリップ本体と筒状部材の斜視図である。FIG. 8 is a perspective view of a clip main body and a cylindrical member constituting the living body compression clip 1E. 図９Ａは、生体圧迫クリップ１Ｅの斜視図である。FIG. 9A is a perspective view of the living body compression clip 1E. 図９Ｂは、生体圧迫クリップ１Ｅの斜視図である。FIG. 9B is a perspective view of the living body compression clip 1E. 図９Ｃは、生体圧迫クリップ１Ｅの斜視図である。FIG. 9C is a perspective view of the living body compression clip 1E. 図１０Ａは、生体圧迫クリップ１Ｅの使用方法の説明図である。FIG. 10A is an explanatory diagram of a method of using the biological compression clip 1E. 図１０Ｂは、生体圧迫クリップ１Ｅの使用方法の説明図である。FIG. 10B is an explanatory diagram of a method of using the biological compression clip 1E. 図１０Ｃは、生体圧迫クリップ１Ｅの使用方法の説明図である。FIG. 10C is an explanatory diagram of a method of using the biological compression clip 1E. 図１１は、生体圧迫クリップ１Ｆを構成するクリップ本体と筒状部材の斜視図である。FIG. 11 is a perspective view of a clip body and a cylindrical member constituting the living body compression clip 1F. 図１２は、生体圧迫クリップ１Ｆの使用方法の説明図である。FIG. 12 is an explanatory diagram of a method for using the living body compression clip 1F. 図１３は、生体圧迫クリップ１Ｇを構成するクリップ本体と筒状部材の斜視図である。FIG. 13 is a perspective view of a clip body and a cylindrical member constituting the living body compression clip 1G. 図１４Ａは、生体圧迫クリップ１Ｇの使用方法の説明図である。FIG. 14A is an explanatory diagram of a method of using the biological compression clip 1G. 図１４Ｂは、生体圧迫クリップ１Ｇの使用方法の説明図である。FIG. 14B is an explanatory diagram of a method of using the biological compression clip 1G. 図１４Ｃは、生体圧迫クリップ１Ｇの使用方法の説明図である。FIG. 14C is an explanatory diagram of a method of using the biological compression clip 1G. 図１５は、生体圧迫クリップ１Ｈを構成するクリップ本体と筒状部材の斜視図である。FIG. 15 is a perspective view of a clip body and a cylindrical member constituting the living body compression clip 1H. 図１６Ａは、生体圧迫クリップ１Ｈの使用方法の説明図である。FIG. 16A is an explanatory diagram of a method of using the biological compression clip 1H. 図１６Ｂは、生体圧迫クリップ１Ｈの使用方法の説明図である。FIG. 16B is an explanatory diagram of a method of using the biological compression clip 1H. 図１６Ｃは、生体圧迫クリップ１Ｈの使用方法の説明図である。FIG. 16C is an explanatory diagram of a method of using the biological compression clip 1H. 図１７Ａは、実施例１の生体圧迫クリップを粘膜面に取り付けたブタ胃の漿膜面に照明光を照射した場合の漿膜面の観察画像である。FIG. 17A is an observation image of the serosal surface when illumination light is irradiated to the serosal surface of the porcine stomach in which the biological compression clip of Example 1 is attached to the mucosal surface. 図１７Ｂは、実施例１の生体圧迫クリップを粘膜面に取り付けたブタ胃の漿膜面に照明光及び励起光を照射した場合の漿膜面の観察画像である。FIG. 17B is an observation image of the serosal surface when illumination light and excitation light are irradiated to the serosal surface of the porcine stomach in which the biological compression clip of Example 1 is attached to the mucosal surface. 図１８Ａは、比較例１の生体圧迫クリップを粘膜面に取り付けたブタ胃の漿膜面に照明光を照射した場合の漿膜面の観察画像である。FIG. 18A is an observation image of the serosal surface when illumination light is irradiated to the serosal surface of the porcine stomach in which the biological compression clip of Comparative Example 1 is attached to the mucosal surface. 図１８Ｂは、比較例１の生体圧迫クリップを粘膜面に取り付けたブタ胃の漿膜面に照明光及び励起光を照射した場合の漿膜面の観察画像である。FIG. 18B is an observation image of the serosal surface when illumination light and excitation light are irradiated on the serosal surface of the porcine stomach where the biological compression clip of Comparative Example 1 is attached to the mucosal surface.
　以下、図面を参照しつつ本発明を詳細に説明する。なお、各図中、同一符号は同一又は同等の構成要素を表している。
＜生体圧迫クリップ１Ａの全体構成＞
　図１は本発明の一実施例の生体圧迫クリップ１Ａを構成するクリップ本体１０と筒状部材２０の斜視図であり、図２Ａはクリップ本体１０の屈曲部１３側に筒状部材２０を取り付けた状態の生体圧迫クリップ１Ａの斜視図であり、図２Ｂは、クリップ本体１０に取り付けた筒状部材２０をクリップ本体１０の挟持部１２側に摺動させた状態の生体圧迫クリップ１Ａの斜視図であり、図２Ｃは、クリップ本体１０に筒状部材２０が締着している状態の生体圧迫クリップ１Ａの斜視図である。 Hereinafter, the present invention will be described in detail with reference to the drawings. In each figure, the same numerals indicate the same or equivalent components.
<Overall structure of living body compression clip 1A>
FIG. 1 is a perspective view of a clip main body 10 and a cylindrical member 20 constituting a living body compression clip 1A according to an embodiment of the present invention. FIG. 2A is a perspective view of a cylindrical member 20 attached to the bent portion 13 side of the clip main body 10. 2B is a perspective view of the biological compression clip 1A in a state, and FIG. 2B is a perspective view of the biological compression clip 1A in a state in which the cylindrical member 20 attached to the clip main body 10 is slid to the clamping portion 12 side of the clip main body 10. FIG. 2C is a perspective view of the biological compression clip 1A in a state where the tubular member 20 is fastened to the clip body 10.
　この生体圧迫クリップ１Ａのクリップ本体１０は、帯状の金属板の中央部を屈曲させた板バネで形成されており、対向する一対のアーム部１１を有している。一対のアーム部１１の先端部は、対向するようにＬ字型に折れ曲がった一対の挟持部１２となっており、アーム部１１は挟持部１２側で幅広に形成されている。この挟持部１２が形成されているクリップ本体１０の端部が、生体圧迫クリップ１Ａが粘膜を挟持している状態におけるクリップ本体１０の粘膜側端部となる。
　なお、本発明において、クリップ本体１０は一対のアーム部を有するのに限られず、３本以上のアーム部を有していてもよい。 The clip main body 10 of the living body compression clip 1A is formed by a leaf spring in which a central portion of a belt-like metal plate is bent, and has a pair of opposing arm portions 11. The distal ends of the pair of arm portions 11 are a pair of sandwiching portions 12 bent in an L shape so as to face each other, and the arm portions 11 are formed wide on the sandwiching portion 12 side. The end portion of the clip main body 10 where the holding portion 12 is formed becomes the mucosa-side end portion of the clip main body 10 in a state where the biological compression clip 1A holds the mucosa.
In the present invention, the clip body 10 is not limited to having a pair of arm portions, and may have three or more arm portions.
　一方、筒状部材２０は、励起光の照射により赤色乃至近赤外光を発光する可撓性の蛍光樹脂で筒型に成形されており、その周壁には、筒状部材２０の軸方向に伸びて筒状部材２０の一端に到る２本のスリット２１が形成されている。この２本のスリット２１は、クリップ本体１０に筒状部材２０を取り付けた状態でクリップ本体１０のアーム部１１上に位置するように、対向する位置に形成されている。また、筒状部材２０の周壁が２本のスリット２１によって分割されることにより形成された短冊状部分２２が、後述するように、この生体圧迫クリップ１Ａにおける押圧部となる。筒状部材２０で粘膜を押圧する際に、短冊状部分２２の粘膜側の端部が外径方向に広がるように、短冊状部分２２を予め形づけておくことが好ましい。 On the other hand, the cylindrical member 20 is formed into a cylindrical shape with a flexible fluorescent resin that emits red or near-infrared light when irradiated with excitation light, and the peripheral wall thereof is formed in the axial direction of the cylindrical member 20. Two slits 21 extending to one end of the cylindrical member 20 are formed. The two slits 21 are formed at opposing positions so as to be positioned on the arm portion 11 of the clip body 10 with the cylindrical member 20 attached to the clip body 10. Further, a strip-shaped portion 22 formed by dividing the peripheral wall of the cylindrical member 20 by the two slits 21 becomes a pressing portion in the living body compression clip 1A as will be described later. When pressing the mucous membrane with the tubular member 20, it is preferable to shape the strip-shaped portion 22 in advance so that the end of the strip-shaped portion 22 on the mucosal side spreads in the outer diameter direction.
　筒状部材２０をクリップ本体１０上で挟持部１２側に摺動させた場合に、短冊状部分（押圧部）２２がクリップ本体１０の端部よりも所定の長さ突出した状態で、筒状部材２０がクリップ本体１０に締着し、固定されるように、スリット２１が形成されていない領域の筒状部材２０の内径は、クリップ本体１０のアーム部１１の挟持部１２側を通すことができない大きさとなっている。 When the cylindrical member 20 is slid to the clamping part 12 side on the clip main body 10, the strip-shaped part (pressing part) 22 protrudes a predetermined length from the end of the clip main body 10, and is cylindrical. The inner diameter of the cylindrical member 20 in the region where the slit 21 is not formed can be passed through the holding part 12 side of the arm part 11 of the clip body 10 so that the member 20 is fastened and fixed to the clip body 10. The size is not possible.
　また、筒状部材２０の大きさに関し、生体圧迫クリップ１Ａを、内視鏡用のシースを通して粘膜に取り付けすることができるように、外径Ｌ1を１．５～２．５ｍｍ、肉厚Ｌ2を０．１～０．３ｍｍとすることが好ましい。一方、筒状部材２０の挟持部１２側端部を、後述するように押圧部として使用する点から、全長Ｌ3を４～６ｍｍ、スリット２１の長さＬ4を２～３ｍｍとすることが好ましい。 Further, regarding the size of the cylindrical member 20, the outer diameter L1 is set to 1.5 to 2.5 mm and the wall thickness L2 is set so that the living body compression clip 1A can be attached to the mucous membrane through the sheath for the endoscope. The thickness is preferably 0.1 to 0.3 mm. On the other hand, it is preferable that the total length L3 is 4 to 6 mm and the length L4 of the slit 21 is 2 to 3 mm from the viewpoint that the end of the cylindrical member 20 on the side of the sandwiching portion 12 is used as a pressing portion as will be described later.
　クリップ本体１０に筒状部材２０を取り付ける方法としては、クリップ本体１０を、一対のアーム部１１が連続する屈曲部１３側を筒状部材２０の短冊状部分２２側から挿入する。その際、筒状部材２０のスリット２１がアーム部１１上にくるようにする。これにより、図２Ａに示すように、クリップ本体１０は、板バネの弾性力でその一対のアーム部１１の挟持部１２側が開いた＞字形形状となる。この場合、短冊状部分２２の少なくとも挟持部１２側は、スリット２１を上面とした場合の側面視において、それぞれ一対のアーム部１１の間に位置する。 As a method of attaching the cylindrical member 20 to the clip main body 10, the clip main body 10 is inserted into the bent portion 13 side where the pair of arm portions 11 are continuous from the strip-shaped portion 22 side of the cylindrical member 20. At that time, the slit 21 of the cylindrical member 20 is arranged on the arm portion 11. As a result, as shown in FIG. 2A, the clip body 10 has a> -letter shape in which the holding portion 12 side of the pair of arm portions 11 is opened by the elastic force of the leaf spring. In this case, at least the sandwiching portion 12 side of the strip-shaped portion 22 is positioned between the pair of arm portions 11 in a side view when the slit 21 is the top surface.
　図２Ｂに示すように、クリップ本体１０に取り付けた筒状部材２０をクリップ本体１０の屈曲部１３側から挟持部１２側へ摺動させると、＞字形に開いていたクリップ本体１０の一対のアーム部１１は閉じる。図２Ｃに示すように、筒状部材２０をさらに挟持部１２側に摺動させると、筒状部材２０はクリップ本体１０に締着し、一対のアーム部１１が閉じた状態で筒状部材２０はクリップ本体１０に固定される。このとき、筒状部材２０の短冊状部分（押圧部）２２は、アーム部１１の先端部よりも筒状部材２０の軸方向に突出している。 As shown in FIG. 2B, when the cylindrical member 20 attached to the clip body 10 is slid from the bent portion 13 side to the clamping portion 12 side of the clip body 10, a pair of arms of the clip body 10 opened in a letter shape Part 11 is closed. As shown in FIG. 2C, when the tubular member 20 is further slid toward the holding portion 12, the tubular member 20 is fastened to the clip body 10 and the pair of arm portions 11 are closed, and the tubular member 20 is closed. Is fixed to the clip body 10. At this time, the strip-shaped portion (pressing portion) 22 of the cylindrical member 20 protrudes in the axial direction of the cylindrical member 20 from the distal end portion of the arm portion 11.
＜蛍光色素＞
　筒状部材２０は、蛍光色素を可撓性樹脂に混練した蛍光樹脂により形成されている。蛍光色素としては、６００～１４００ｎｍの赤色乃至近赤外の波長域の蛍光を発するものが好ましい。このような波長域の光は、皮膚、脂肪、筋肉等の人体組織に対して透過性が高く、生体の組織表面下５ｍｍ～２０ｍｍ程度まで良好に到達することができる。 <Fluorescent dye>
The cylindrical member 20 is formed of a fluorescent resin in which a fluorescent dye is kneaded with a flexible resin. As the fluorescent dye, those that emit fluorescence in the red to near-infrared wavelength region of 600 to 1400 nm are preferable. Light in such a wavelength range is highly permeable to human tissues such as skin, fat and muscle, and can reach well to about 5 mm to 20 mm below the tissue surface of the living body.
　上述の波長域の蛍光を発する蛍光色素としては、リボフラビン、チアミン、ＮＡＤＨ(nicotinamide adenine dinucleotide)、インドシアニングリーン（ＩＣＧ）等の水溶性色素や、特開２０１１－１６２４４５号公報に記載のアゾ－ホウ素錯体化合物等の油溶性色素をあげることができる。中でも、生体内で溶出することなく安定に樹脂に保持される点から樹脂に相溶性の高い色素が好ましく、特に、特開２０１１－１６２４４５号公報に記載のアゾ－ホウ素錯体化合物等が蛍光の発光強度に優れ、ポリウレタン等の樹脂に対する相溶性、耐光性、耐熱性にも優れる点で好ましい。 Examples of fluorescent dyes that emit fluorescence in the above-described wavelength range include water-soluble dyes such as riboflavin, thiamine, NADH (nicotinamide adenine dinucleotide), indocyanine green (ICG), and azo-boron described in JP2011-162445A. Oil-soluble dyes such as complex compounds can be mentioned. Of these, dyes that are highly compatible with the resin are preferred because they are stably retained in the resin without being eluted in the living body. In particular, the azo-boron complex compounds described in JP2011-162445A emit fluorescent light. It is preferable in terms of excellent strength and compatibility with resins such as polyurethane, light resistance, and heat resistance.
　蛍光樹脂における蛍光色素の好ましい濃度は、当該蛍光色素やバインダーとする樹脂の種類にもよるが、通常、０．１～０．００１質量％とすることが好ましい。 The preferred concentration of the fluorescent dye in the fluorescent resin is usually 0.1 to 0.001% by mass, although it depends on the type of the fluorescent dye and the resin used as the binder.
　一方、蛍光色素を含有させる可撓性樹脂としては、ポリウレタン、ポリプロピレン、ポリエチレン、ポリ塩化ビニル、ポリアミド、ポリアミドエラストマー等に、必要に応じて硬化剤を配合したものを使用することができ、硬化後のショア硬度が６０Ｄ～７０Ｄとなるものが好ましい。このような硬度の樹脂を使用することにより、クリップ本体１０で粘膜組織を挟持している状態で、筒状部材２０の押圧部２２によって粘膜を圧迫し、その圧迫部位の毛細血管網の血管を虚脱させ易くなる。 On the other hand, as a flexible resin containing a fluorescent dye, polyurethane, polypropylene, polyethylene, polyvinyl chloride, polyamide, polyamide elastomer, etc., which can be blended with a curing agent as necessary, can be used. Those having a Shore hardness of 60D to 70D are preferred. By using the resin having such hardness, the mucous membrane is pressed by the pressing portion 22 of the cylindrical member 20 in a state where the clip body 10 holds the mucosal tissue, and the blood vessels of the capillary network at the compression site are compressed. It becomes easy to collapse.
　可撓性樹脂に蛍光色素を含有させる方法としては、例えば、二軸混練機を使用して樹脂に蛍光色素を混練する。その後、押出成形または射出成形にて所定の筒型形状に成形し、スリット形成、定尺カット、角取り等の加工を施すことで、筒状部材２０を得ることができる。 As a method of incorporating the fluorescent dye into the flexible resin, for example, the fluorescent dye is kneaded into the resin using a biaxial kneader. Thereafter, the cylindrical member 20 can be obtained by forming into a predetermined cylindrical shape by extrusion molding or injection molding, and performing processing such as slit formation, fixed cut, and chamfering.
　蛍光樹脂には、必要に応じて硫酸バリウム等の造影剤を添加してもよい。これにより、生体内で粘膜を挟持していた生体圧迫クリップ１Ａが粘膜から外れても、生体内の生体圧迫クリップ１Ａを、Ｘ線を用いて撮影することにより追跡することが可能となる。 If necessary, a contrast agent such as barium sulfate may be added to the fluorescent resin. Thereby, even if the living body compression clip 1A holding the mucous membrane in the living body is detached from the mucous membrane, the living body pressing clip 1A in the living body can be tracked by photographing using X-rays.
　なお、本実施例の生体圧迫クリップ１Ａの筒状部材２０は、蛍光色素を含有する樹脂で筒形に成形したものであるが、本発明において、筒状部材２０としては、少なくとも押圧部２２となる部分が蛍光色素を有しているものを使用することができる。したがって、筒状部材２０は、蛍光色素を含有する樹脂塗料で表面をコートしたものであってもよい。また、筒状部材２０は、蛍光色素を内部に含有する樹脂で筒形に成形したものに、蛍光色素を内部に含有しない透明樹脂で外表面をコートしたり二層化したりしたものであってもよい。蛍光色素を含有しない筒状部材の内表面に蛍光色素をゼラチン等で固定したものでもよい。
　また、クリップ本体１０を、蛍光色素を含有するプラスチックバネで形成してもよく、クリップ本体１０の表面を蛍光色素を含有する樹脂塗料でコートしてもよい。
　蛍光色素の安定性の点からは、樹脂に相溶性の高い蛍光色素を使用し、蛍光色素を混練りした樹脂で筒状部材２０を形成することが好ましい。 In addition, although the cylindrical member 20 of the living body compression clip 1A of the present embodiment is formed into a cylindrical shape with a resin containing a fluorescent dye, in the present invention, as the cylindrical member 20, at least the pressing portion 22 and The part which has a fluorescent dye can be used. Therefore, the cylindrical member 20 may have a surface coated with a resin paint containing a fluorescent dye. In addition, the cylindrical member 20 is formed by forming a cylindrical shape with a resin containing a fluorescent dye inside, and coating the outer surface with a transparent resin not containing the fluorescent dye inside or making it into two layers. Also good. It is also possible to fix the fluorescent dye with gelatin or the like on the inner surface of the cylindrical member not containing the fluorescent dye.
The clip body 10 may be formed of a plastic spring containing a fluorescent dye, and the surface of the clip body 10 may be coated with a resin paint containing a fluorescent dye.
From the viewpoint of the stability of the fluorescent dye, it is preferable to use a fluorescent dye highly compatible with the resin and to form the cylindrical member 20 with a resin in which the fluorescent dye is kneaded.
＜生体圧迫クリップ１Ａの使用方法＞
　生体圧迫クリップ１Ａの使用方法としては、まず、図２Ａに示すように、クリップ本体１０に筒状部材２０を取り付け、図３Ａに示すように、内視鏡と共に使用するクリップ用シース３０内に入れる。クリップ用シース３０としては、例えば、特許４３８８３２４号公報、特許５０４５４８４号公報等に記載されているインナーシース３１とアウターシース３２と操作ワイヤー３３を有するものを使用することができ、市販のものを使用することができる。 <Usage method of living body compression clip 1A>
As a method of using the biological compression clip 1A, first, as shown in FIG. 2A, the cylindrical member 20 is attached to the clip body 10, and as shown in FIG. 3A, the clip is inserted into the clip sheath 30 used with the endoscope. . As the sheath 30 for a clip, what has the inner sheath 31, the outer sheath 32, and the operation wire 33 described in patent 4388324 gazette, patent 5045484 gazette etc. can be used, for example, it uses a commercially available thing. can do.
　クリップ用シース３０を管腔臓器の内部に挿入し、アウターシース３２から生体圧迫クリップ１Ａを突出させると、図３Ｂに示すように、クリップ本体１０のアーム部１１の挟持部１２側が開く。次に、図３Ｃに示すように、インナーシース３１で筒状部材２０を挟持部１２側に摺動させることにより、クリップ本体１０の挟持部１２で、管腔臓器内部の疾患部４１近傍の粘膜組織４０を挟持する。さらに、インナーシース３１で筒状部材２０を挟持部１２側に摺動させ、図３Ｄに示すように筒状部材２０をクリップ本体１０に締着させ、筒状部材２０をクリップ本体１０に固定する。これにより、粘膜組織４０がクリップ本体１０で挟持され、クリップ本体１０の粘膜４０側端部より粘膜４０側に突出した筒状部材２０の押圧部２２が、粘膜４０の厚さを薄くする方向に粘膜４０を圧迫する。図３Ｅは、この粘膜４０の圧迫による作用の説明図であって、圧迫部分及びその近傍の領域Ｐの拡大図である。押圧部２２が粘膜４０を圧迫することにより、粘膜下層の血管網４２が圧縮され、血管から血液が排除され、ヘモグロビンも排除される。 When the clip sheath 30 is inserted into the luminal organ and the living body compression clip 1A is protruded from the outer sheath 32, the holding part 12 side of the arm part 11 of the clip body 10 is opened as shown in FIG. 3B. Next, as shown in FIG. 3C, the tubular member 20 is slid toward the clamping part 12 by the inner sheath 31, so that the mucous membrane in the vicinity of the diseased part 41 inside the luminal organ at the clamping part 12 of the clip body 10. The tissue 40 is sandwiched. Furthermore, the cylindrical member 20 is slid to the clamping part 12 side by the inner sheath 31, the cylindrical member 20 is fastened to the clip main body 10 as shown in FIG. 3D, and the cylindrical member 20 is fixed to the clip main body 10. . Thus, the mucosal tissue 40 is sandwiched between the clip main body 10, and the pressing portion 22 of the tubular member 20 protruding from the end of the clip main body 10 toward the mucosa 40 side reduces the thickness of the mucosa 40. The mucous membrane 40 is compressed. FIG. 3E is an explanatory diagram of the action by the compression of the mucous membrane 40, and is an enlarged view of the compressed portion and the region P in the vicinity thereof. When the pressing portion 22 compresses the mucous membrane 40, the vascular network 42 in the submucosal layer is compressed, blood is excluded from the blood vessel, and hemoglobin is also excluded.
　したがって、管腔臓器の外側（漿膜側）に赤色乃至近赤外の波長域の励起光ＬAを照射すると、その励起光ＬAは、押圧部２２を形成する蛍光樹脂に、ヘモグロビンで殆ど吸収阻害されることなく吸収され、蛍光樹脂が赤色乃至近赤外の波長域の蛍光ＬBを発する。この蛍光ＬBは、ヘモグロビンで殆ど吸収阻害されることなく管腔臓器の外側に出射する。したがって、蛍光樹脂が発する蛍光を管腔臓器の外側から良好に視認することができ、管腔臓器の内部に挟持させた生体圧迫クリップ１Ａの位置がわかり、疾患部４１の位置を特定することができる。 Therefore, when the excitation light LA in the red to near-infrared wavelength region is irradiated to the outside (serosa side) of the luminal organ, the excitation light LA is hardly absorbed by hemoglobin in the fluorescent resin forming the pressing portion 22. Without being absorbed, and the fluorescent resin emits fluorescence LB in the red to near-infrared wavelength region. The fluorescence LB is emitted to the outside of the luminal organ with almost no absorption inhibition by hemoglobin. Therefore, the fluorescence emitted from the fluorescent resin can be viewed well from the outside of the luminal organ, the position of the biological compression clip 1A held inside the luminal organ can be known, and the position of the diseased part 41 can be specified. it can.
　ここで、管腔臓器の漿膜側に励起光ＬAを照射する方法としては、開胸又は開腹により管腔臓器の漿膜を露出させ、そこに励起光ＬAを照射してもよく、また、ラパロスコープ（手術用内視鏡）を胸壁又は腹壁に開けた孔より挿入し、管腔臓器の漿膜面あるいは腹膜面を観察しながら、赤色乃至近赤外の波長域の励起光ＬAを管腔臓器の漿膜面あるいは腹膜面に照射してもよい。 Here, as a method of irradiating the serosa side of the luminal organ with the excitation light LA, the serosa of the luminal organ may be exposed by thoracotomy or laparotomy, and the excitation light LA may be irradiated therewith. (Surgery endoscope) is inserted through a hole in the chest wall or abdominal wall, and while observing the serosal surface or peritoneal surface of the luminal organ, the excitation light LA in the red to near-infrared wavelength region is emitted from the luminal organ. The serosal surface or peritoneal surface may be irradiated.
　なお、管腔臓器の外側から観察する蛍光が可視光でない場合には、公知の赤外可視変換ガラスを通して観察することにより、あるいは、管腔臓器を外側から撮影し、画像処理で蛍光を可視化することにより、容易に発光部位を特定することができる。 If the fluorescence observed from the outside of the luminal organ is not visible light, the fluorescence is visualized by observing through a known infrared-visible conversion glass or by photographing the luminal organ from the outside and performing image processing. Thus, the light emitting site can be easily specified.
　この生体圧迫クリップ１Ａは、食道、胃、大腸等の消化管粘膜、気管粘膜、膀胱粘膜、子宮粘膜等に取り付け可能であり、これらの管腔臓器の疾患部位をマークすることが可能となる。 This biological compression clip 1A can be attached to digestive tract mucosa such as esophagus, stomach, large intestine, tracheal mucosa, urinary bladder mucosa, uterine mucosa and the like, and it becomes possible to mark a diseased site of these luminal organs.
＜生体圧迫クリップ１Ｂ～１Ｄ＞
　本発明の生体圧迫クリップは、種々の態様をとることができる。例えば、図４Ａに示す生体圧迫クリップ１Ｂは、上述の生体圧迫クリップ１Ａにおいて、筒状部材２０にステンレス等で形成された金属リング２９を取り付けたものである。これにより図４Ｂに示すように、クリップ本体１０を締め付ける筒状部材２０の耐久性を向上させ、クリップ本体１０が粘膜４０を挟持する力の低下を防止することができる。 <Biological compression clips 1B-1D>
The living body compression clip of the present invention can take various forms. For example, a living body compression clip 1B shown in FIG. 4A is obtained by attaching a metal ring 29 made of stainless steel or the like to the tubular member 20 in the above-described living body compression clip 1A. As a result, as shown in FIG. 4B, the durability of the cylindrical member 20 that tightens the clip body 10 can be improved, and a reduction in the force with which the clip body 10 holds the mucous membrane 40 can be prevented.
　図５Ａに示す生体圧迫クリップ１Ｂは、上述の生体圧迫クリップ１Ａにおいて、筒状部材２０に形成する、筒状部材２０の軸方向に伸びたスリット２１の数を３以上としたものである。 A biological compression clip 1B shown in FIG. 5A has three or more slits 21 extending in the axial direction of the cylindrical member 20 formed in the cylindrical member 20 in the biological compression clip 1A described above.
　この生体圧迫クリップ１Ｂによれば、図５Ｂに示すように、筒状部材２０をクリップ本体１０に締着させ、クリップ本体１０のアーム部１１で粘膜組織４０を挟持した状態で、３以上の短冊状部分からなる押圧部２２で粘膜４０が圧迫される。したがって、前述の生体圧迫クリップ１Ａに対して製造工程は複雑になるものの、粘膜を押圧している部分の押圧部２２の形状が円形により近づき、漿膜側からの視認時に生体圧迫クリップ１Ｂの位置をより正確に認識可能となる。 According to this biological compression clip 1B, as shown in FIG. 5B, three or more strips are formed in a state in which the tubular member 20 is fastened to the clip body 10 and the mucosal tissue 40 is sandwiched between the arm portions 11 of the clip body 10. The mucous membrane 40 is pressed by the pressing portion 22 formed of a dent portion. Therefore, although the manufacturing process is complicated with respect to the above-described living body compression clip 1A, the shape of the pressing portion 22 of the portion pressing the mucous membrane becomes closer to a circle, and the position of the living body compression clip 1B is visible when viewed from the serosa side. It becomes possible to recognize more accurately.
　図６Ａに示す生体圧迫クリップ１Ｃは、上述の生体圧迫クリップ１Ａにおいて、筒状部材２０の一端に、スリット２１に代えて、多数のハーフカット２３を形成したものである。この生体圧迫クリップ１Ｃによれば、図６Ｂに示すように、クリップ本体１０が粘膜組織４０を挟持した状態で、筒状部材２０の一端が粘膜４０を押圧した場合に、その筒状部材２０の一端が拡径するので、粘膜４０をリング状に圧迫することができる。 A living body compression clip 1C shown in FIG. 6A is obtained by forming a large number of half-cuts 23 in place of the slits 21 at one end of the tubular member 20 in the above-described living body compression clip 1A. According to this biological compression clip 1C, as shown in FIG. 6B, when one end of the tubular member 20 presses the mucous membrane 40 with the clip body 10 sandwiching the mucosal tissue 40, the tubular member 20 Since one end is expanded in diameter, the mucous membrane 40 can be compressed in a ring shape.
　図７Ａに示す生体圧迫クリップ１Ｄは、上述の生体圧迫クリップ１Ａにおいて、筒状部材２０にスリット２１を形成することなく、筒状部材２０を厚肉に形成したものである。また、クリップ本体１０上で筒状部材２０を摺動させ、筒状部材２０をクリップ本体１０に締着させた状態で、押圧部２２がクリップ本体１０の挟持部１２よりも粘膜側に突出するように、筒状部材２０の押圧部２２を拡径させている。筒状部材２０の押圧部２２を拡径させることで、クリップ本体１０のアーム部１１との摺動抵抗が弱まり、筒状部材２０が粘膜側に突出しやすくなる。 A biological compression clip 1D shown in FIG. 7A is obtained by forming the cylindrical member 20 thick without forming the slit 21 in the cylindrical member 20 in the biological compression clip 1A described above. Further, in a state where the tubular member 20 is slid on the clip body 10 and the tubular member 20 is fastened to the clip body 10, the pressing portion 22 protrudes to the mucous membrane side from the sandwiching portion 12 of the clip body 10. In this way, the diameter of the pressing portion 22 of the cylindrical member 20 is increased. By increasing the diameter of the pressing portion 22 of the cylindrical member 20, the sliding resistance with the arm portion 11 of the clip body 10 is weakened, and the cylindrical member 20 is likely to protrude to the mucosa side.
　この生体圧迫クリップ１Ｄによれば、図７Ｂに示すように、クリップ本体１０が粘膜４０を挟持し、筒状部材２０の一端が粘膜４０を押圧した場合に、粘膜４０をリング状に圧迫することができる。 According to this biological compression clip 1D, as shown in FIG. 7B, when the clip body 10 holds the mucous membrane 40 and one end of the tubular member 20 presses the mucous membrane 40, the mucous membrane 40 is compressed in a ring shape. Can do.
＜生体圧迫クリップ１Ｅ＞
　図８は、さらに異なる本発明の実施例の生体圧迫クリップ１Ｅを構成するクリップ本体１０と筒状部材２０の斜視図である。
　この生体圧迫クリップ１Ｅは、筒状部材２０が一端に底部２４を有する有底筒型形状をしており、この底部２４が押圧部として作用する。筒状部材２０の周壁は、筒状部材２０の軸方向に底部２４に延び、底部２４も部分的に切り欠いた一対のスリット２５を有してる。ここで、スリット２５の幅Ｌ5は、アーム部１１の挟持部１２側を通すことのできる長さとなっている。
　この生体圧迫クリップ１Ｅは、筒状部材２０の形状の他は、前述の生体圧迫クリップ１Ａと同様に構成されている。 <Biological compression clip 1E>
FIG. 8 is a perspective view of the clip body 10 and the cylindrical member 20 constituting the living body compression clip 1E of another embodiment of the present invention.
The living body compression clip 1E has a bottomed cylindrical shape in which the tubular member 20 has a bottom 24 at one end, and the bottom 24 acts as a pressing portion. The peripheral wall of the cylindrical member 20 has a pair of slits 25 that extend to the bottom 24 in the axial direction of the cylindrical member 20, and the bottom 24 is also partially cut away. Here, the width L5 of the slit 25 is a length that allows the arm portion 11 to pass through the holding portion 12 side.
The living body compression clip 1E is configured in the same manner as the living body compression clip 1A described above except for the shape of the cylindrical member 20.
　図９Ａは、生体圧迫クリップ１Ｅのクリップ本体１０に筒状部材２０を取り付けた状態の斜視図である。筒状部材２０のスリット２５にクリップ本体１０のアーム部１１が挿入されることにより、クリップ本体１０はアーム部１１の挟持部１２側が開いた＞字形形状となっている。 FIG. 9A is a perspective view of a state in which the cylindrical member 20 is attached to the clip body 10 of the biological compression clip 1E. By inserting the arm portion 11 of the clip main body 10 into the slit 25 of the cylindrical member 20, the clip main body 10 has a> -letter shape in which the clamping portion 12 side of the arm portion 11 is opened.
　図９Ｂに示すように、この生体圧迫クリップ１Ｅでは、筒状部材２０を、クリップ本体１０の屈曲部１３側から挟持部１２側へ摺動させると、筒状部材２０においてスリット２５が形成されていない領域が、アーム部１１の広幅部分に達することにより、開いていた一対のアーム部１１が閉じる。図９Ｃに示すように、さらに筒状部材２０を挟持部１２側で摺動させると、筒状部材２０はクリップ本体１０に締着するが、このとき筒状部材２０の底部２４は、アーム部１１の挟持部１２よりも屈曲部１３側にある。
　また、筒状部材２０がクリップ本体１０に締着した状態で、一対の挟持部１２は、間隔をあけて対向している。 As shown in FIG. 9B, in this living body compression clip 1E, when the cylindrical member 20 is slid from the bent portion 13 side of the clip body 10 to the clamping portion 12 side, a slit 25 is formed in the cylindrical member 20. When the non-region reaches the wide portion of the arm portion 11, the pair of open arm portions 11 are closed. As shown in FIG. 9C, when the tubular member 20 is further slid on the holding portion 12 side, the tubular member 20 is fastened to the clip body 10. At this time, the bottom portion 24 of the tubular member 20 is an arm portion. 11 is closer to the bent portion 13 than the sandwiching portion 12.
In addition, in a state where the cylindrical member 20 is fastened to the clip main body 10, the pair of sandwiching portions 12 are opposed to each other with a gap therebetween.
＜生体圧迫クリップ１Ｅの使用方法＞
　生体圧迫クリップ１Ｅの使用時には、前述の生体圧迫クリップ１Ａと同様にインナーシース３１とアウターシース３２を有するクリップ用シース３０を使用する（図３Ａ～図３Ｄ）。図１０Ａは、シースを管腔臓器の内部に挿入し、アウターシース３２から生体圧迫クリップ１Ａを突出させることにより、クリップ本体１０のアーム部１１の挟持部１２側を開かせた状態を示している。 <Usage of biological compression clip 1E>
When the biological compression clip 1E is used, the clip sheath 30 having the inner sheath 31 and the outer sheath 32 is used as in the aforementioned biological compression clip 1A (FIGS. 3A to 3D). FIG. 10A shows a state where the sandwiching portion 12 side of the arm portion 11 of the clip body 10 is opened by inserting the sheath into the hollow organ and causing the living body compression clip 1A to protrude from the outer sheath 32. .
　インナーシースで筒状部材２０を挟持部１２側に摺動させることにより、開いていたアーム部１１が閉じるので、図１０Ｂに示すように、アーム部１１の挟持部１２で粘膜４０を挟持することができる。 By sliding the cylindrical member 20 to the clamping part 12 side with the inner sheath, the opened arm part 11 is closed, so that the mucous membrane 40 is clamped by the clamping part 12 of the arm part 11 as shown in FIG. 10B. Can do.
　さらにインナーシースで筒状部材２０をアーム部１１の挟持部１２側に摺動させ、図１０Ｃに示すように、筒状部材２０をクリップ本体１０に締着させ、固定する。これにより、挟持部１２で挟持された粘膜４０が、底部（押圧部）２４によって、粘膜４０の厚さが薄くなる方向に圧迫される。したがって、図３Ｅに示した場合と同様に、この部分の粘膜下層の血管網から血液が排除され、ヘモグロビンも排除される。よって、底部２４には管腔臓器の外側から照射された励起光が十分に到達し、励起光の照射により底部２４から発せられた蛍光が管腔臓器の外側に出射し、管腔臓器の外側から蛍光の発光部位を特定することが可能となる。 Further, the cylindrical member 20 is slid to the clamping portion 12 side of the arm portion 11 with the inner sheath, and the cylindrical member 20 is fastened to the clip body 10 and fixed as shown in FIG. 10C. Thereby, the mucous membrane 40 clamped by the clamping part 12 is pressed by the bottom part (pressing part) 24 in the direction where the thickness of the mucous membrane 40 becomes thin. Therefore, as in the case shown in FIG. 3E, blood is excluded from the vascular network of the submucosa in this portion, and hemoglobin is also excluded. Accordingly, the excitation light emitted from the outside of the hollow organ reaches the bottom 24 sufficiently, and the fluorescence emitted from the bottom 24 due to the irradiation of the excitation light is emitted to the outside of the hollow organ, and the outside of the lumen organ. From this, it becomes possible to specify the fluorescence emission site.
＜生体圧迫クリップ１Ｆ＞
　図８～図１０Ｃに示した生体圧迫クリップ１Ｅのように、筒状部材２０を有底筒状に形成する場合に、図１１に示す生体圧迫クリップ１Ｆのように、底部２４に凸部２６を形成してもよい。
　この生体圧迫クリップ１Ｆによれば、図１２に示すように、クリップ本体１０に筒状部材２０を締着させ、挟持部１２で粘膜４０を挟持した場合に、挟持部１２で挟持されている粘膜４０を凸部２６によって圧迫することができる。したがって、粘膜４０をより強く圧迫することができ、圧迫部分での血管網からの血液の排除をより徹底させることができる。 <Biological compression clip 1F>
When the cylindrical member 20 is formed in a bottomed cylindrical shape like the biological compression clip 1E shown in FIGS. 8 to 10C, the convex portion 26 is formed on the bottom portion 24 like the biological compression clip 1F shown in FIG. It may be formed.
According to this biological compression clip 1F, as shown in FIG. 12, when the tubular member 20 is fastened to the clip body 10 and the mucous membrane 40 is clamped by the clamping unit 12, the mucous membrane clamped by the clamping unit 12 40 can be pressed by the convex portion 26. Therefore, the mucous membrane 40 can be more strongly compressed, and blood can be more thoroughly excluded from the vascular network at the compressed portion.
＜生体圧迫クリップ１Ｇ＞
　図１３に示すクリップ本体１０と筒状部材２０からなる生体圧迫クリップ１Ｇは、図８に示した生体圧迫クリップ１Ｅにおいて、筒状部材２０の底部２４の切欠部を、アーム部１１の挟持部１２側端部の出し入れが可能となるように広げることにより底部２４を帯状に形成し、かつ底部２４近傍の周壁を、帯状の底部２４が延設されたように形成し、これにより、スリット２５を上面にした場合の上面視で、筒状部材２０の底部２４とその近傍がコ字形となるように形成したものである。 <Biological compression clip 1G>
A biological compression clip 1G including the clip main body 10 and the cylindrical member 20 shown in FIG. 13 is the same as the biological compression clip 1E shown in FIG. The bottom portion 24 is formed in a band shape by spreading it so that the side end portion can be taken in and out, and the peripheral wall in the vicinity of the bottom portion 24 is formed so that the band-like bottom portion 24 is extended, whereby the slit 25 is formed. The bottom portion 24 of the cylindrical member 20 and the vicinity thereof are formed in a U-shape when viewed from the top.
　この生体圧迫クリップ１Ｇによれば、図１４Ａに示すように、クリップ本体１０に筒状部材２０を取り付け、クリップ本体１０が粘膜４０を挟持する前の状態では、スリット２５から一対のアーム部１１が突出し、クリップ本体１０は、一対のアーム部１１の挟持部１２側が開いた＞字形形状となっている。図１４Ｂに示すように、クリップ本体１０の挟持部１２を粘膜４０に押し当て、筒状部材２０をクリップ本体１０の挟持部１２側に摺動させると、クリップ本体１０の挟持部１２側が閉じ始め、さらに、筒状部材２０を挟持部１２側に摺動させると、図１４Ｃに示すように、筒状部材２０はクリップ本体１０に締着し、挟持部１２が粘膜組織４０を挟持する。このとき、筒状部材２０の底部２４は、クリップ本体１０の挟持部１２よりも粘膜４０の内部に押し込まれている。そのため、挟持部１２が、筒状部材２０の底部２４の屈曲部１３側に粘膜組織４０を被せ、底部２４が粘膜組織４０の内部に係留される。 According to the living body compression clip 1G, as shown in FIG. 14A, the pair of arm portions 11 is formed from the slit 25 in a state before the tubular member 20 is attached to the clip body 10 and the clip body 10 holds the mucous membrane 40. The clip body 10 protrudes and has a> -shaped shape in which the sandwiching portion 12 side of the pair of arm portions 11 is opened. As shown in FIG. 14B, when the clamping part 12 of the clip body 10 is pressed against the mucous membrane 40 and the cylindrical member 20 is slid toward the clamping part 12 of the clip body 10, the clamping part 12 side of the clip body 10 begins to close. When the tubular member 20 is further slid toward the sandwiching portion 12, the tubular member 20 is fastened to the clip body 10 as shown in FIG. 14C, and the sandwiching portion 12 sandwiches the mucosal tissue 40. At this time, the bottom portion 24 of the cylindrical member 20 is pushed into the mucous membrane 40 rather than the clamping portion 12 of the clip body 10. Therefore, the sandwiching portion 12 covers the mucosal tissue 40 on the bent portion 13 side of the bottom 24 of the cylindrical member 20, and the bottom 24 is anchored inside the mucosal tissue 40.
　この状態で漿膜側から励起光を照射すると、励起光は、クリップ本体１０の挟持部１２で遮られることなく、筒状部材２０の底部２４に達し、また、底部２４から発せられる蛍光が挟持部１２で遮られることなく漿膜側に出射する。したがって、底部２４から発せられる蛍光を漿膜側からより確実に観察することが可能となる。 When excitation light is irradiated from the serosa side in this state, the excitation light reaches the bottom portion 24 of the cylindrical member 20 without being blocked by the sandwiching portion 12 of the clip body 10, and fluorescence emitted from the bottom portion 24 is sandwiched by the sandwiching portion. 12 is emitted to the serosa side without being blocked. Therefore, the fluorescence emitted from the bottom 24 can be more reliably observed from the serosa side.
＜生体圧迫クリップ１Ｈ＞
　図１５に示すクリップ本体１０と筒状部材２０からなる生体圧迫クリップ１Ｈは、図１３に示した生体圧迫クリップ１Ｇにおいて、筒状部材２０の内部を長手方向に延びた２室に区切る平板状の中板２７を設け、その中板２７の一端面で筒状部材２０の底部２４が形成されるようにし、中板２７が筒状部材２０の片側で突出するようにしたものである。この中板２７の底部２４側端部には、穴２８が貫通している。また、筒状部材２０では、図１３の生体圧迫クリップ１Ｇにおける長手方向のスリット２５が省略されている。 <Biological compression clip 1H>
A biological compression clip 1H composed of the clip body 10 and the cylindrical member 20 shown in FIG. 15 is a flat plate-like partition that divides the inside of the cylindrical member 20 into two chambers extending in the longitudinal direction in the biological compression clip 1G shown in FIG. An intermediate plate 27 is provided, and the bottom 24 of the cylindrical member 20 is formed on one end surface of the intermediate plate 27, and the intermediate plate 27 protrudes on one side of the cylindrical member 20. A hole 28 passes through an end of the intermediate plate 27 on the bottom 24 side. Moreover, in the cylindrical member 20, the slit 25 of the longitudinal direction in the biological compression clip 1G of FIG. 13 is abbreviate | omitted.
　図１６Ａは、この生体圧迫クリップ１Ｈのクリップ本体１０に筒状部材２０を取り付け、クリップ本体１０で粘膜４０を挟持する前の状態を示している。この生体圧迫クリップ１Ｈにおいても、図１６Ｂに示すように、クリップ本体１０の挟持部１２を粘膜４０に押し当て、筒状部材２０をクリップ本体１０の挟持部１２側に摺動させると、クリップ本体１０の挟持部１２側が閉じ始め、さらに、筒状部材２０を挟持部１２側に摺動させると、図１６Ｃに示すように、筒状部材２０はクリップ本体１０に締着し、挟持部１２が、中板２７の穴２８の中に入り込み、粘膜組織４０を挟持する。このとき、筒状部材２０の底部２４は、クリップ本体１０の挟持部１２よりも粘膜４０の内部に押し込まれている。そのため、筒状部材２０の底部２４の屈曲部１３側に粘膜組織４０が被さり、底部２４が粘膜組織４０の内部に係留される。 FIG. 16A shows a state before the cylindrical member 20 is attached to the clip main body 10 of the living body compression clip 1H and the mucous membrane 40 is clamped by the clip main body 10. Also in this living body compression clip 1H, as shown in FIG. 16B, when the clamping part 12 of the clip body 10 is pressed against the mucous membrane 40 and the cylindrical member 20 is slid toward the clamping part 12 of the clip body 10, the clip body When the holding member 12 side of 10 starts to close and the cylindrical member 20 is further slid to the holding portion 12 side, the cylindrical member 20 is fastened to the clip body 10 as shown in FIG. Then, it enters into the hole 28 of the intermediate plate 27 and sandwiches the mucosal tissue 40. At this time, the bottom portion 24 of the cylindrical member 20 is pushed into the mucous membrane 40 rather than the clamping portion 12 of the clip body 10. Therefore, the mucosal tissue 40 covers the bent portion 13 side of the bottom 24 of the cylindrical member 20, and the bottom 24 is anchored inside the mucosal tissue 40.
　よって、この生体圧迫クリップ１Ｈによっても、漿膜側から照射された励起光が、クリップ本体１０の挟持部１２で遮られず、また、筒状部材２０の底部２４から発せられた蛍光がクリップ本体１０の挟持部１２で遮られることもない。 Therefore, even with this living body compression clip 1H, the excitation light irradiated from the serosa side is not blocked by the clamping part 12 of the clip body 10, and the fluorescence emitted from the bottom 24 of the cylindrical member 20 is not clipped. It is not obstructed by the sandwiching part 12.
　以下、実施例に基づき、本発明を具体的に説明する。
　実施例１、比較例１
（１）生体圧迫クリップの作製
　本発明者により特開２０１１－１６２４４５号公報に開示されたアゾ－ホウ素錯体化合物のうち公開公報における表１の実施例１（２）の化合物をショア硬度６５Ｄの医療用ポリウレタンに、濃度０．０５質量％となるように添加し、溶融混練し、押し出し成形し、蛍光色素配合の樹脂チューブ（内径１．６ｍｍ、外径２．０ｍｍ、肉厚０．２ｍｍ）を作成した。 Hereinafter, based on an Example, this invention is demonstrated concretely.
Example 1 and Comparative Example 1
(1) Production of living body compression clip Among the azo-boron complex compounds disclosed in Japanese Patent Application Laid-Open No. 2011-162445 by the present inventor, the compound of Example 1 (2) in Table 1 of the public gazette is a medical with a Shore hardness of 65D. Add to polyurethane for concentration to 0.05% by mass, melt knead, extrude, and add resin tube with fluorescent dye (inner diameter 1.6mm, outer diameter 2.0mm, wall thickness 0.2mm) Created.
　このチューブに一対のスリットを入れ、図１に示す形状の生体圧迫クリップ１Ａの筒状部材２０を作製した。 A pair of slits were put into this tube to produce a cylindrical member 20 of the biological compression clip 1A having the shape shown in FIG.
　また、図１に示す生体圧迫クリップのクリップ本体１０と同形状のクリップ本体を備える市販のクリップ装置から締めリングを外したものをクリップ本体１０として使用し、このクリップ本体１０に上述の筒状部材２０を取り付け、実施例１の生体圧迫クリップを得た。 Further, the clip body 10 obtained by removing the fastening ring from a commercially available clip device having a clip body having the same shape as the clip body 10 of the biological compression clip shown in FIG. 1 is used as the above-described cylindrical member. 20 was attached, and the living body compression clip of Example 1 was obtained.
　一方、比較例１として、特開２００５－２１８６８０号公報の図２０に開示されている形状のクリップを作製した。この場合、当該図２０の符号２１４にあたる部材を上述の蛍光色素配合の樹脂チューブで作製した。 On the other hand, as Comparative Example 1, a clip having a shape disclosed in FIG. 20 of JP-A-2005-218680 was produced. In this case, the member corresponding to reference numeral 214 in FIG. 20 was made of the above-described resin tube containing the fluorescent dye.
（２）評価
　クリップ装置の先端に実施例１の生体圧迫クリップ又は比較例１のクリップを把持させ
た状態で、クリップ装置先端を医療用軟性内視鏡の生検口に挿入し、ブタの胃粘膜に係留した。 (2) Evaluation With the clip of Example 1 or the clip of Comparative Example 1 held at the tip of the clip device, the tip of the clip device is inserted into the biopsy port of the medical flexible endoscope, and the stomach of the pig Moored in mucosa.
　また、そのブタの胃に、近赤外蛍光観察用ラパロスコープ（Ｋａｒｌ　Ｓｔｏｒｚ社、テレスコープ２６００３ＢＧＡ）を経腹壁的に挿入した。該ラパロスコープには、６８０～７８０ｎｍの波長域の近赤外光を遮断する光学フィルターが内蔵されている。
　該ラパロスコープの接眼部と近赤外蛍光カラーカメラ（ミズホ株式会社、ＭＮＩＲＣ－１００）を接続した。この場合、近赤外蛍光カラーカメラのレンズに代えて、ラパロスコープに付属のアダプターレンズを装着した。 A laparoscope for near-infrared fluorescence observation (Karl Storz, Telescope 26003BGA) was inserted into the stomach of the pig transperitoneally. The rapaloscope has a built-in optical filter that blocks near-infrared light in the wavelength range of 680 to 780 nm.
The eyepiece of the Rapaloscope was connected to a near-infrared fluorescent color camera (Mizuho Co., Ltd., MNIRC-100). In this case, instead of the lens of the near-infrared fluorescent color camera, an adapter lens attached to the laparoscope was attached.
　ラパロスコープのライトガイド接続部に、４００ｎｍ～６５０ｎｍの波長の白色照明光と、６８０ｎｍ～７８０ｎｍの励起光の両方、もしくは、白色照明光のみを照射することのできるファイバー光源を接続し、実施例１及び比較例１のクリップを係留したブタの胃の夫々について、漿膜面に白色照明光及び励起光を照射した場合と白色照明光のみを照射した場合の該漿膜面をラパロスコープで観察した。この場合、白色照明光の強度は、被写体照度１０００ルクスとし、励起光の強度は３０ｍＷ／ｃｍ２とした。樹脂チューブに配合した蛍光色素から発せられる近赤外蛍光は、映像表示色として緑色が割り当てられた。 A fiber light source capable of irradiating both white illumination light having a wavelength of 400 nm to 650 nm and excitation light having a wavelength of 680 nm to 780 nm, or only white illumination light is connected to the light guide connection portion of the rapaloscope. And about each of the stomach of the pig which tethered the clip of the comparative example 1, when the serosal surface was irradiated with white illumination light and excitation light, and when only the white illumination light was irradiated, the serosal surface was observed with a laparoscope. In this case, the intensity of the white illumination light was 1000 lux for the subject illumination, and the intensity of the excitation light was 30 mW / cm 2 . The near-infrared fluorescence emitted from the fluorescent dye blended in the resin tube was assigned green as the video display color.
　この結果を図１７Ａ、図１７Ｂ、図１８Ａ、図１８Ｂに示す。このうち、図１７Ａは、実施例１の生体圧迫クリップを係留した部位の漿膜面に白色照明光のみを照射し、その漿膜面を撮影した画像であり、図１７Ｂは同じ漿膜面に、白色照明光および励起光を同時照射し、その漿膜面を撮影した画像である。なお、この画像をグレースケールで表示した場合に、蛍光色素から発せられる蛍光に割り当てられた緑色光と表面反射光とを画像上で区別できないため、図１７Ｂでは、緑色光の明度をゼロに表示した。また、図１８Ａは、比較例１のクリップを係留した部位の漿膜面に白色照明光のみを照射し、その漿膜面を撮影した画像であり、図１８Ｂは同じ漿膜面に、白色照明光および励起光を同時照射し、その漿膜面を撮影した画像である。図１８Ｂにおいて、黒線の円は比較例１のクリップを係留した粘膜面の位置を表している。図１８Ｂには、蛍光色素から発せられた蛍光を認めることができない。 The results are shown in FIGS. 17A, 17B, 18A, and 18B. 17A is an image obtained by irradiating only the serosal surface of the site where the living body compression clip of Example 1 was anchored with white illumination light and photographing the serosal surface, and FIG. 17B shows the same serosal surface with white illumination. It is the image which imaged the serosal surface by irradiating light and excitation light simultaneously. Note that when this image is displayed in gray scale, the green light assigned to the fluorescence emitted from the fluorescent dye and the surface reflected light cannot be distinguished on the image, so in FIG. 17B, the brightness of the green light is displayed as zero. did. FIG. 18A is an image obtained by irradiating only the serosal surface of the site where the clip of Comparative Example 1 is anchored with white illumination light and photographing the serosal surface, and FIG. 18B is an image of white illumination light and excitation on the same serosal surface. It is the image which imaged the serosal surface by irradiating light simultaneously. In FIG. 18B, the black circle represents the position of the mucosal surface where the clip of Comparative Example 1 was anchored. In FIG. 18B, fluorescence emitted from the fluorescent dye cannot be recognized.
　漿膜面の撮影後、ブタの胃を摘出し、胃壁の厚さを測ったところ、６～７ｍｍであった。 After photographing the serosal surface, the stomach of the pig was removed and the thickness of the stomach wall was measured to be 6-7 mm.
　以上の結果から、実施例１の生体圧迫クリップを胃粘膜面に係留すると、その位置を胃漿膜面からの観察により可視化することができるが、比較例１のクリップでは、同様の可視化を行うことができないことがわかる。これは、実施例１の生体圧迫クリップによれば、胃粘膜が圧迫され、粘膜下層の血管網の血管が虚脱されるが、比較例１のクリップでは、蛍光色素を配合した樹脂チューブによって胃粘膜が圧迫されず、粘膜下層の血管網の血管の虚脱も生じないためと考えられる。 From the above results, when the living body compression clip of Example 1 is anchored on the gastric mucosa surface, the position can be visualized by observation from the gastric serosa surface, but the clip of Comparative Example 1 performs the same visualization. I can't understand. According to the living body compression clip of Example 1, the gastric mucosa is compressed, and the blood vessels of the vascular network in the submucosa are collapsed. In the clip of Comparative Example 1, the gastric mucosa is formed by a resin tube containing a fluorescent dye. This is thought to be because the blood vessels in the submucosal vascular network do not collapse.
　１Ａ’、１Ａ、１Ｂ、１Ｃ、１Ｄ、１Ｅ、１Ｆ、１Ｇ、１Ｈ　生体圧迫クリップ
１０　　クリップ本体
１１　　アーム部
１２　　挟持部
１３　　屈曲部
２０　　筒状部材
２１　　スリット
２２　　短冊状部分（押圧部）
２３　　ハーフカット
２４　　底部
２５　　スリット
２６　　凸部
２７　　中板
２８　　穴
２９　　金属リング
３０　　シース
３１　　インナーシース
３２　　アウターシース
３３　　操作ワイヤー
４０　　粘膜、粘膜組織
４１　　疾患部
４２　　粘膜下層の血管網
　Ｄ　　粘膜の厚さ 1A ′, 1A, 1B, 1C, 1D, 1E, 1F, 1G, 1H Biological compression clip 10 Clip body 11 Arm portion 12 Clamping portion 13 Bending portion 20 Tubular member 21 Slit 22 Strip portion (pressing portion)
23 Half-cut 24 Bottom 25 Slit 26 Protrusion 27 Middle plate 28 Hole 29 Metal ring 30 Sheath 31 Inner sheath 32 Outer sheath 33 Operating wire 40 Mucosa, mucosal tissue 41 Diseased part 42 Submucosal vascular network D Mucosal thickness

Claims (7)

  1. 　クリップ本体、及びクリップ本体に摺動可能に取り付けられ、クリップ本体に締着する筒状部材を備えた生体圧迫クリップであって、
    クリップ本体は筒状部材の締着により管腔臓器の粘膜組織を挟持するアーム部を有し、筒状部材は、該筒状部材のクリップ本体への締着によりクリップ本体が管腔臓器の粘膜組織を挟持している状態で、粘膜の厚さを薄くする方向に粘膜を圧迫する押圧部を有し、該押圧部が、励起光の照射により赤色乃至近赤外光を発光する蛍光色素を有する生体圧迫クリップ。     A clip body, and a biological compression clip that is slidably attached to the clip body and includes a cylindrical member that fastens to the clip body,
    The clip main body has an arm portion that clamps the mucosal tissue of the luminal organ by fastening the cylindrical member, and the cylindrical member is attached to the clip main body of the tubular member by the clip main body. A pressing part that presses the mucous membrane in the direction of decreasing the thickness of the mucous membrane while sandwiching the tissue, and the pressing part emits a fluorescent dye that emits red to near-infrared light when irradiated with excitation light. A living body compression clip.
  2. 　筒状部材が、蛍光色素を含有する樹脂を用いて形成されている請求項１記載の生体圧迫クリップ。 The living body compression clip according to claim 1, wherein the cylindrical member is formed using a resin containing a fluorescent dye.
  3. 　クリップ本体が管腔臓器の粘膜組織を挟持している状態で、筒状部材の押圧部が、クリップ本体の粘膜側端部よりも粘膜側に突出している請求項１又は２記載の生体圧迫クリップ。 The living body compression clip according to claim 1 or 2, wherein the pressing portion of the tubular member protrudes more toward the mucosa side than the end portion of the clip body on the mucosa side while the clip body holds the mucosal tissue of the luminal organ. .
  4. 　筒状部材が、筒状部材の軸方向に伸びた２本以上のスリットを有する請求項１～３のいずれかに記載の生体圧迫クリップ。 The living body compression clip according to any one of claims 1 to 3, wherein the cylindrical member has two or more slits extending in an axial direction of the cylindrical member.
  5. 　筒状部材が、押圧部として、スリットで分割することにより形成された短冊状部分を有する請求項１～４のいずれかに記載の生体圧迫クリップ。 The living body compression clip according to any one of claims 1 to 4, wherein the cylindrical member has a strip-like portion formed by dividing with a slit as a pressing portion.
  6. 　筒状部材が、押圧部として、筒状部材の一端に底部を有する請求項１～４のいずれかに記載の生体圧迫クリップ。 The biological compression clip according to any one of claims 1 to 4, wherein the cylindrical member has a bottom portion at one end of the cylindrical member as a pressing portion.
  7. 　筒状部材がその一端に底部を有し、該底部に、押圧部として、クリップ本体が粘膜組織を挟持している状態で粘膜側に突出する凸部を有する請求項１～４のいずれかに記載の生体圧迫クリップ。 The cylindrical member has a bottom portion at one end thereof, and the bottom portion has, as a pressing portion, a convex portion protruding toward the mucosa side in a state where the clip body holds the mucosal tissue. Biological compression clip as described.
PCT/JP2015/065513 2014-05-29 2015-05-29 Living body pressing clip WO2015182737A1 (en)

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019189864A1 (en) 2018-03-30 2019-10-03 日本ゼオン株式会社 Indwelling clip
WO2019189863A1 (en) 2018-03-30 2019-10-03 日本ゼオン株式会社 Indwelling clip
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