WO2017057504A1 - 粘弾性組成物 - Google Patents
粘弾性組成物 Download PDFInfo
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- WO2017057504A1 WO2017057504A1 PCT/JP2016/078704 JP2016078704W WO2017057504A1 WO 2017057504 A1 WO2017057504 A1 WO 2017057504A1 JP 2016078704 W JP2016078704 W JP 2016078704W WO 2017057504 A1 WO2017057504 A1 WO 2017057504A1
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- endoscope
- viscoelastic composition
- securing
- viscoelastic
- visual field
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Definitions
- the present invention relates to a viscoelastic composition suitable for use for securing an endoscope visual field and a method for securing an endoscope visual field using the viscoelastic composition. More specifically, it is suitable for the purpose of securing the endoscope's field of view by pushing away the liquid when dark liquid that cannot be seen is accumulated inside the tube and the field of view of the endoscope is blocked.
- the present invention relates to a viscoelastic composition having excellent properties and a method for securing a visual field of an endoscope using the viscoelastic composition.
- the endoscope can observe the inside of thin tubes such as the digestive tract and bile duct. However, if dark liquid such as blood, intestinal fluid, bile, etc., or semi-solid matter such as food residues or excreta accumulate in the tube, the field of view of the endoscope is blocked. It is not possible to fully observe the state of the inside. In such a case, conventionally, the endoscope visual field has been secured by supplying water or supplying air to the inside of the tube.
- the water supply is a method in which water such as tap water is injected into the pipe to wash away the liquid or semi-solid inside the pipe.
- Patent Document 1 discloses a method for treating urinary incontinence, anal incontinence, or vesicoureteral reflux by injecting a hydrogel composed of a crosslinked polymer into the urethra or rectum.
- Patent Document 2 discloses a hydrogel composition having a polysaccharide, a synthetic polymer, and a crosslinking agent. This hydrogel composition appears to be cross-linked and cured by a buffer solution into a tacky hydrogel.
- Patent Document 3 discloses a method for inflating a body cavity such as the uterus by filling a physiological fluid such as physiological saline or lactated Ringer's solution to treat the body cavity.
- the subject of the present invention is suitable for an application that secures the endoscope's visual field by pushing away the liquid when a dark color liquid that cannot be seen is accumulated inside the tube and the visual field of the endoscope is blocked,
- An object of the present invention is to provide a viscoelastic composition excellent in operability and a method for securing a visual field of an endoscope using such a viscoelastic composition.
- Another object of the present invention is to provide a viscoelastic composition capable of assisting simple hemostasis treatment.
- the inventors of the present invention are useful to use a viscoelastic composition having elasticity as well as viscosity, and in particular, by specifying physical properties of hardness, viscosity, loss tangent, It has been found that the endoscope has excellent operability and a good visual field can be secured, and the present invention described below has been completed. Furthermore, it has been found that by adjusting the electrical conductivity of the viscoelastic composition according to the present invention, a simple hemostasis treatment can be assisted while ensuring a good visual field.
- a viscoelastic composition for securing a visual field of an endoscope containing a thickening substance and water.
- the viscoelastic composition according to [1] having a hardness of 550 N / m 2 or less, a viscosity at 25 ° C. of 200 to 2000 mPa ⁇ s, and a loss tangent of 0.6 or less.
- the viscoelastic composition according to [2] further having an electric conductivity of 250 ⁇ S / cm or less.
- the viscoelastic composition of the present invention has properties of viscosity and elasticity, and the viscoelasticity can physically push away liquids such as blood, intestinal juice, bile and semi-solids such as food residues and excreta. is there.
- this viscoelasticity is difficult to mix with the previous liquid or semi-solid, it does not suspend and has a moderate unity, so it does not diffuse and a good visual field can be secured.
- the viscoelastic composition of the present invention does not contain a substance having a charge or minimizes the electric conductivity by containing it, thereby ensuring electric field while ensuring a visual field in the presence of the viscoelastic composition. Enables support for hemostasis measures by cutting or electrocoagulation.
- thermocoagulation process using the high frequency current which imitated the process with an endoscope. It is a figure which shows the result of the thermocoagulation process using the high frequency current which imitated the process with an endoscope. It is a figure which shows the result of the thermocoagulation process using the high frequency current which imitated the process with an endoscope. It is a figure which shows the result of the thermocoagulation process using the high frequency current which imitated the process with an endoscope. It is a figure which shows the result of the thermocoagulation process using the high frequency current which imitated the process with an endoscope.
- the viscoelastic composition of the present invention contains a thickening substance and water.
- the viscoelastic composition of the present invention is prepared by combining one or more thickening substances having an effect of increasing viscosity when dispersed in water.
- thickening substances include methanol, ethanol, 2-propanol, 1,4-butanediol, 1,3-butylene glycol, propylene glycol, glycerin catechin, glucose, fructose, galactose, sucrose, lactose, and maltose.
- the water used in the viscoelastic composition of the present invention is not particularly limited, but is preferably a physiological aqueous solution such as soft water, pure water, deionized water, distilled water, physiological saline, Ringer's solution, or Ringer's acetate solution.
- a physiological aqueous solution such as soft water, pure water, deionized water, distilled water, physiological saline, Ringer's solution, or Ringer's acetate solution.
- the viscoelastic composition of the present invention may contain additives such as preservatives and preservatives.
- An object of the present invention is to provide a viscoelastic composition that is excellent in operability and can ensure a good visual field, and preferably provides a viscoelastic composition that enables simple hemostasis treatment.
- the factors that obstruct the field of view of the endoscope are: 1) liquids such as blood, intestinal fluid, bile, and semi-solids such as food residues and excrement accumulate in the lumen; 2) water It is considered that 3) fluidity and diffusion due to water supply.
- these substances are injected by injecting into the lumen a transparent composition having viscoelasticity different from semisolids such as liquids such as blood, intestinal fluid, bile and excrement.
- the subject that it is excellent in operativity means that this viscoelastic composition can be passed through the forceps port of an endoscope without excessive resistance.
- the problem of enabling easy hemostasis treatment means that the bleeding site can be confirmed in the presence of the viscoelastic composition, and that hemostasis treatment using high-frequency current can be assisted. To do.
- the viscoelastic composition of the present invention has a hardness of 550 N / m 2 or less, preferably 400 N / m 2 or less, a viscosity (25 ° C.) of 200 to 2000 mPa ⁇ s, preferably 500 to 1500 mPa ⁇ s, and a loss tangent. Is preferably 0.6 or less.
- the viscoelastic composition of the present invention preferably has an electric conductivity of 250 ⁇ S / cm or less, more preferably 200 ⁇ S / cm or less. Moreover, by setting the electric conductivity within the above range, a viscoelastic composition excellent in thermocoagulation and hemostasis and particularly suitable for treatment such as electrocutting or electrocoagulation can be obtained.
- the viscoelastic composition of the present invention can be obtained by mixing a thickening substance as described above with water. Specifically, two or more kinds of the thickening substances are combined, or one kind of thickening substance is added. It can be obtained by dissolving in water or the like and applying elasticity by heat treatment.
- the viscoelastic composition of the present invention is preferably substantially free of bubbles because the visual field is blocked when bubbles are present in the composition.
- the method for securing the visual field of the endoscope of the present invention includes feeding the viscoelastic composition of the present invention from the proximal portion of the endoscope to the distal end portion of the endoscope through the channel.
- FIG. 1 is a view showing a photograph of a proximal portion of a medical endoscope as a typical example of an endoscope.
- a dial 11 for performing an angle operation a scope connector portion 12 for transmitting light from a light source device and transmitting image information to an electronic endoscope processor, and treatment tools such as forceps are inserted.
- a forceps port 15 for sending to the distal end portion 1 is provided.
- the endoscope flexible tube 17 is provided with a channel communicating from the forceps opening to the distal end, a water supply tube for cleaning the lens at the distal end, and an optical system.
- a forceps lid 16 is attached to the forceps port 15 of the medical endoscope shown in FIG.
- One end of the tube 13 is connected to the forceps lid 16, and the other end of the tube is connected to a connector 14 for mounting a syringe or the like.
- a valve body in the forceps lid 16 and one end of the tube 13 is open on the wall surface of the valve body in the forceps lid 16 on the side of the forceps port 15, and the valve body is also inserted when a treatment instrument such as a forceps is inserted. This prevents the liquid sent through the tube from flowing out (see, for example, Japanese Patent Application No. 2014-155777).
- An endoscope can be inserted into a digestive tract such as a rectum, and the inside of the digestive tract can be observed with an endoscope. If there is bleeding in the digestive tract 4, blood 3 accumulates in the digestive tract and the bleeding site 2 cannot be observed (FIG. 2A). In such a case, the syringe is filled with tap water, and with this syringe, water is sent from the opening of the endoscope distal end 1 to the digestive tract through the tube 13, the forceps port 15, and the channel, and the accumulated blood is collected. Tried to rinse with water. However, the accumulated blood and the supplied water were mixed and suspended, and became muddy water 3 ".
- Example and Comparative Example In this example or comparative example, the relationship between the viscoelastic characteristics of the viscoelastic composition used in the endoscope and the securing of the visual field and operability in the endoscope operation was examined.
- Viscosity and loss tangent Viscosity / viscosity is measured using HAAKE RS-6000 (Thermo Fisher Scientific Co., Ltd.). The viscoelastic composition was placed on a sample stage and measured using a P35 Ti L parallel plate (measurement conditions: temperature 25 degrees, gap 1.000 mm, stress 1000 mPa, frequency 0.5000 Hz), and the value 30 minutes after the start of measurement. Measured.
- the result obtained by this visual field securing evaluation corresponds to a difference in provision of the visual field as shown in FIGS. 9 and 10, for example. That is, when an endoscope was inserted into the bleeding site and water was injected, as shown in FIG. 9, the field of view obtained from the camera due to cloudy water was poor. Further, when an endoscope was inserted into the bleeding site and a viscoelastic composition exhibiting the desired viscoelastic properties was injected, the bleeding site 2 was clearly in the visual field obtained from the camera as shown in FIG. I was able to grasp.
- the viscoelastic composition used for securing the visual field is injected into the digestive tract through the forceps port (inner diameter 2.8 to 3.8 mm) of the endoscope, so that it can be injected smoothly without excessive resistance. Is desirable.
- a viscoelastic composition that can pass smoothly or has a slight resistance but is in a practically acceptable range was determined to be “suitable”.
- a viscoelastic composition that is too resistant to withstand practical use, or too resistant to pass through was determined to be “unsuitable”.
- the viscoelastic composition determined to be “suitable” for operability had a hardness of about 550 N / m 2 or less and a viscosity of about 2000 mPa ⁇ s or less, and all the above were “unsuitable” (FIG. 7). .
- the loss tangent and hardness of the viscoelastic composition satisfying both “pass” for securing the visual field and “suitable” for operability were the same values as above (FIG. 8).
- a viscoelastic composition excellent in visual field securing and operability in endoscopic treatment has a loss tangent of 0.6 or less, a hardness of 550 N / cm 2 or less, and a viscosity of 200 to 2000 mPa ⁇ s. It turned out to be preferable.
- thermocoagulation method a tissue is coagulated and stopped by heat generated by a high-frequency current flowing through the bleeding site and concentrated on the bleeding site. At this time, generally, if a solution or substance having a high electrical conductivity exists around the bleeding site, a high-frequency current leaks, and sufficient thermal coagulation cannot be performed. Based on this knowledge, processing and evaluation were performed according to the following procedure.
- a small tube (diameter: about 1.5 cm) is pressure-bonded to the liver surface of a rat, and the inside is filled with physiological saline, distilled water, or a viscoelastic composition prepared to have different electrical conductivity, and a monopolar tip (Edge)
- the coating blade electrode E1450X was lightly applied to the liver surface and energized for 2 seconds in a coagulation mode (Surgestat II, Covidien Japan Co., Ltd., set to coagulation output 20). Sufficient thermal coagulation was observed in the gas phase (Fig. 11) and tap water with low electrical conductivity (Fig. 12), but poor thermal coagulation was observed in physiological saline with high electrical conductivity (Fig. 13). It was.
- the viscoelastic composition excellent in visual field securing and operability in endoscopic treatment has an electrical conductivity of preferably 25 mS / m or less, more preferably in consideration of thermocoagulation hemostasis using a high-frequency current.
- an electrical conductivity preferably 25 mS / m or less, more preferably in consideration of thermocoagulation hemostasis using a high-frequency current.
- Table 2 shows viscoelastic compositions that are evaluated as “suitable” in operability in endoscopic treatment, and that achieve thermal coagulation using a high-frequency current, and also show the pass / fail of securing a visual field for each. .
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Abstract
Description
特許文献2は、多糖類及び合成ポリマーと架橋剤を有するヒドロゲル組成物を開示している。このヒドロゲル組成物は緩衝液によって架橋硬化して粘着性ヒドロゲルになるようである。
特許文献3は、生理塩水または乳酸塩化したリンゲル溶液のような生理的流体を充填することによって子宮などの体腔を膨らませて該体腔内を治療する方法を開示している。
〔2〕 硬さが550N/m2以下、25℃における粘度が200~2000mPa・sであり、損失正接が0.6以下である、〔1〕に記載の粘弾性組成物。
〔3〕 さらに、電気伝導率が250μS/cm以下である、〔2〕に記載の粘弾性組成物。
内視鏡の手元部から、チャンネルを通して、内視鏡の先端部に送り込み、
内視鏡の視野を確保する方法。
〔5〕 内視鏡が医療用内視鏡である、〔4〕に記載の方法。
硬さを上述の範囲とすることにより、内視鏡の鉗子を通じての注入時の操作性が良好となる。また、粘度および損失正接を上述の範囲とすることにより、視野確保の観点で改善される。なお、視野確保の観点から、粘弾性組成物は透明であってもよい。
また、電気伝導率を上述の範囲とすることにより、熱凝固止血に優れ、特に電気切断または電気凝固などの処置に好適な粘弾性組成物が得られる。
内視鏡を例えば直腸などの消化管に挿入し、内視鏡で消化管内を観察することができる。消化管4に出血があると消化管内に血液3が溜まって出血部位2を観察することができない(図2A)。このようなとき、シリンジに水道水を充填し、該シリンジで、チューブ13、鉗子口15、およびチャンネルを経て、内視鏡先端部1の開口から水を消化管に送り込み、溜まっていた血液を水で洗い流すことを試みた。ところが、溜まっていた血液と送り込んだ水とが混ぎりあって懸濁され、濁り水3”となってしまった。濁り水3”が消化管内に溜まると、内視鏡の視野が濁り水3”で遮られてしまい、出血部位2を観察することができず、手術を続行できない(図2B、図9)。
なお、本発明の粘弾性組成物によれば、図3A、図3Bに示したように、消化管4に出血部位2が生じた場合、内視鏡の先端部からこの粘弾性組成物を送り込むことにより、消化管内に溜まった血液3を押し退け(血液3’)、出血部位2を観察することを可能にする。
本実施例または比較例では、内視鏡に使用する粘弾性組成物の粘弾性特性と、内視鏡操作における視野の確保および操作性との関係について検討した。
粘度・粘弾性HAAKE RS-6000(サーモフィッシャーサイエンティフィック株式会社)を用いて測定する。粘弾性組成物を試料台にのせ、P35 Ti Lパラレルプレートを用いて測定し(測定条件:温度25度、ギャップ1.000mm、応力1000mPa、周波数0.5000Hz)、測定開始30分後の値を計測した。
クリープメータModel RE2-33005C(株式会社山電)を用いて測定する。ステンレスシャーレ(外径45mm、内径41mm、外寸18mm、内寸15mm)に粘弾性組成物を満たし、シャーレの高さに揃えて検体表面を平らにした。プランジャー(株式会社山電、形状:円板、型式:P-56、摘要:φ20×t 8)を用いて測定した(測定条件:格納ピッチ0.02sec、測定歪率66.67%、測定速度10mm/sec、戻り距離5.00mm、サンプル厚さ15.00mm、接触面直径20.00mm、接触面積0.000mm2)。
電気伝導率計CM-41X(東亜DKK株式会社)、低電気伝導率用CT-57101Cセルを用いて測定した(測定条件:温度25度)。
ディーン・スターク管に1%エバンスブルー溶液(色素液)を3mL注入し、針金を取り付けたカテーテルチューブを挿入した。この状態では、色素液によって視野が遮られチューブ先端の針金は見えない(図4A、図5A)。カテーテルチューブ(内径2.5~3mm、長さ1.000mm)を通じて損失正接、硬さ及び粘度の異なる粘性組成物を色素液中に10mL注入し、目視で視野確保の合否を判定した。ある粘性組成物Aを注入したとき、物理的な空間が確保でき、且つ色素液とも混ざり難かったことから、当該粘性組成物Aは所期の粘弾性特性を発揮したと判断され、粘弾性組成物として「合格」と判定した(図4B)。一方、粘性組成物Aとは異なるある粘性組成物Bを注入したとき、物理的な空間の確保が不明瞭であり、色素液との混ざり合いも見られたことから当該粘性組成物Bは所期の粘弾性特性を発揮していないと判断され、粘弾性組成物として「不合格」と判定した(図5B)。
視野確保に用いる粘弾性組成物は、内視鏡の鉗子口(内径2.8~3.8mm)を通じて消化管内に注入するため、過度な抵抗なくスムーズに注入できることが望ましい。損失正接、硬さ及び粘度の異なる粘弾性組成物を50mLシリンジ(株式会社ジェイ・エム・エス)に充填し、シリンジ先端に内視鏡の鉗子口内径を模擬したカテーテルチューブ(内径3mm、長さ1.000mm)を取り付け、粘弾性組成物の通過性を主観的に判定した。スムーズに通過できる、又は若干の抵抗はあるものの実用許容範囲である粘弾性組成物を「適」と判定した。一方、抵抗がありすぎて実用には耐えられない、又は抵抗がありすぎて通過不可である粘弾性組成物を「不適」と判定した。
損失正接、硬さ及び粘度の異なる粘弾性組成物を調製し、各粘弾性組成物について視野確保及び操作性を判定し、各物性値と関連性について評価した。視野確保が「合格」と判定された粘弾性組成物の損失正接は全て約0.6以下であり、それ以上になると全て「不合格」であった(図6)。操作性が「適」と判定された粘弾性組成物の硬さは約550N/m2以下、粘度は約2000mPa・s以下であり、それ以上になると全て「不適」であった(図7)。視野確保が「合格」及び操作性が「適」の両方を満たす粘弾性組成物の損失正接及び硬さは上記と同じ値であった(図8)。これらの実験例から、内視鏡治療における視野確保及び操作性に優れた粘弾性組成物は、損失正接が0.6以下、硬さが550N/cm2以下、粘度が200~2000mPa・sとするのが好ましいことがわかった。
内視鏡による止血には、高周波電流を用いた熱凝固による方法、クリップによる方法、薬剤による方法と3つの方法がある。熱凝固法は、出血部に高周波電流を流して出血部位に集中して発生する熱により組織を凝固止血する。この時、一般的に出血部位周囲に電気伝導率の高い溶液や物質が存在すると高周波電流が漏電してしまい、十分な熱凝固が行えない。
この知見に基づいて、以下の手順で処理及び評価を行った。
ラットの肝表面に小さな筒(直径約1.5cm)を圧着させ、その中を生理食塩液、蒸留水、又は電気伝導率の異なるよう調製した粘弾性組成物で満たし、モノポーラーの先端(Edgeコーティングブレード電極E1450X)を肝表面に軽く当て、凝固モード(サージスタットII、コヴィディエンジャパン株式会社、凝固出力20に設定)で2秒間通電した。気相中(図11)及び電気伝導率の低い水道水中(図12)では十分な熱凝固が見られたが、電気伝導率の高い生理食塩液中(図13)では熱凝固不良が認められた。また、電気伝導率が12.8mS/m(128μS/cm)以下の粘弾性組成物(図14、図15)では十分な熱凝固が見られ、また25mS/m(250μS/cm)以下、例えば22.4mS/m(224μS/cm)以下の粘弾性組成物(図16)では実用上問題ない程度に熱凝固が見られたものの、大きな電気伝導率、例えば60.8mS/m(608μS/cm)(図17)では熱凝固不良が認められた。これらの実験例から、内視鏡治療における視野確保及び操作性に優れた粘弾性組成物は、高周波電流を用いた熱凝固止血を考慮し、電気伝導率が好ましくは25mS/m以下、さらに好ましくは20mS/m以下であることがわかった。結果を以下の表1にも示す。
2 出血部位
3、3’ 血液
3” 濁り水
11 ダイヤル
12 スコープコネクタ部
13 チューブ
14 コネクタ
15 鉗子口
16 鉗子蓋
17 内視鏡軟性管
Claims (5)
- 増粘性物質と水とを含有する内視鏡の視野確保用の粘弾性組成物。
- 硬さが550N/m2以下、25℃における粘度が200~2000mPa・sであり、損失正接が0.6以下である、請求項1に記載の粘弾性組成物。
- さらに、電気伝導率が250μS/cm以下である請求項2に記載の粘弾性組成物。
- 請求項1~3のいずれかひとつに記載の粘弾性組成物を、
内視鏡の手元部から、チャンネルを通して、内視鏡の先端部に送り込むことを含む、
内視鏡の視野を確保する方法。 - 内視鏡が医療用内視鏡である、請求項4に記載の方法。
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TWI820257B (zh) * | 2018-11-22 | 2023-11-01 | 學校法人自治醫科大學 | 內視鏡之視野確保用之黏彈性組合物之用途 |
CN113164009B (zh) * | 2018-11-22 | 2024-05-24 | 学校法人自治医科大学 | 内窥镜的视野确保用的粘弹性组合物 |
WO2022264679A1 (ja) * | 2021-06-16 | 2022-12-22 | 富士フイルム株式会社 | 内視鏡用粘膜下注入材 |
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