JP2020166187A - Medical procedure training skin model, echo image visibility adjustment method in medical procedure training skin model, and puncture procedure training method for ultrasound guiding method - Google Patents
Medical procedure training skin model, echo image visibility adjustment method in medical procedure training skin model, and puncture procedure training method for ultrasound guiding method Download PDFInfo
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Abstract
Description
本発明は、人体の皮膚をシミュレーションして医療処置訓練を行うための医療処置の訓練用皮膚モデル、医療処置の訓練用皮膚モデルのエコー画像の視認性調整方法および超音波ガイド法の穿刺手技訓練方法に関する。 The present invention provides a skin model for medical procedure training for simulating the skin of a human body to perform medical procedure training, a method for adjusting the visibility of an echo image of a skin model for medical procedure training, and a puncture technique training for an ultrasonic guide method. Regarding the method.
超音波診断装置を用いた超音波検査は、現代医療において日常的に行われており、重要な検査となっている。人体の皮膚にプローブを当てると、超音波診断装置のモニタにエコー画像（超音波断層像）が描出される。そのエコー画像を介して体内の検査を行うことができる。
超音波検査は、穿刺の介助にも用いられている。例えば、中心静脈カテーテルの挿入法には、エコー画像を用いる超音波ガイド法（Ultrasound-guided technique）がある。また、超音波ガイド法には、エコーガイド下（超音波ガイド下）に穿刺を行うエコーガイド下による穿刺法（Real-time approach）がある。エコーガイド下による穿刺法は、中心静脈カテーテルの挿入に伴うリスク（合併症）が少ないとも言われている。
Ultrasonography using an ultrasonic diagnostic device is routinely performed in modern medicine and has become an important examination. When the probe is applied to the skin of the human body, an echo image (ultrasound tomography) is drawn on the monitor of the ultrasonic diagnostic equipment. An internal examination can be performed through the echo image.
Ultrasonography is also used to assist in puncture. For example, as a method of inserting a central venous catheter, there is an ultrasonic guided technique (Ultrasound-guided technique) using an echo image. In addition, the ultrasonic guided method includes an echo-guided puncture method (Real-time approach) in which puncture is performed under echo-guided (ultrasonic-guided). The echo-guided puncture method is also said to have less risk (complications) associated with the insertion of a central venous catheter.
しかし、エコーガイド下による穿刺には、熟練した手技が必要となる。そのため、穿刺訓練のために人体の皮膚モデル（模擬皮膚）などの教育機材が求められている。 However, echo-guided puncture requires skillful procedures. Therefore, educational equipment such as a human skin model (simulated skin) is required for puncture training.
現在、医師や技術者などの訓練のために供する人体に近似した超音波ファントムが提供されている（例えば、特許文献１）。 Currently, an ultrasonic phantom similar to the human body used for training of doctors and engineers is provided (for example, Patent Document 1).
特許文献１の超音波ファントムは、母材にポリビニルアルコールを用いて、音響定数を人体のそれに近似させるため、グラファイト、ガラスビーズ、樹脂製微小中空球などの粉体を母材であるポリビニルアルコール懸濁液に混入するものである。これにより、医用超音波の研究、関連装置、器具等の開発製造、医師や技術者などの訓練のために供する、人体に近似した音響特性に調整が容易な、経時安定性に優れた超音波ファントムを提供することができる。 The ultrasonic phantom of Patent Document 1 uses polyvinyl alcohol as the base material, and in order to make the acoustic constant similar to that of the human body, the polyvinyl alcohol suspension using powders such as graphite, glass beads, and resin micro hollow spheres as the base material. It is mixed in the turbid liquid. As a result, ultrasonic waves with excellent temporal stability that can be easily adjusted to acoustic characteristics similar to the human body, which are used for research on medical ultrasonic waves, development and manufacture of related devices and instruments, and training for doctors and engineers. Phantom can be provided.
特許文献１の超音波ファントムでは、音響定数を人体に近似させるためにグラファイトを重量濃度６〜１３％混入させている。しかし、グラファイト重量濃度６〜１３％の超音波ファントムのエコー画像（超音波検査において超音波診断装置のモニタに描出される画像）は、不明瞭なものであり、内部の対象物体を視認できない場合があった。したがって、特許文献１の超音波ファントムは、エコーガイド下による穿刺法の訓練をおこなうための皮膚モデルとして使用することができないものであった。 In the ultrasonic phantom of Patent Document 1, graphite is mixed with a weight concentration of 6 to 13% in order to approximate the acoustic constant to the human body. However, the echo image of the ultrasonic phantom having a graphite weight concentration of 6 to 13% (the image drawn on the monitor of the ultrasonic diagnostic apparatus in the ultrasonic examination) is unclear, and the object inside cannot be visually recognized. was there. Therefore, the ultrasonic phantom of Patent Document 1 cannot be used as a skin model for training the puncture method under echo guidance.
本発明は、上述の問題を解決するものであって、エコーガイド下による穿刺法の訓練をおこなうことができる医療処置の訓練用皮膚モデル、医療処置の訓練用皮膚モデルのエコー画像の視認性調整方法および超音波ガイド法の穿刺手技訓練方法を提供することを目的とする。 The present invention solves the above-mentioned problems, and adjusts the visibility of echo images of a skin model for training a medical procedure and a skin model for training a medical procedure capable of performing puncture method training under echo guidance. It is an object of the present invention to provide a method and a puncture technique training method of an ultrasonic guide method.
本発明の医療処置の訓練用皮膚モデルは、平均重合度が５００〜４０００であり、ケン化度が９５モル％以上のポリビニルアルコールの水溶液と、平均粒子径が１００μｍ以下である非水溶性の粉体又は繊維とを混合する混合液をゲル化したものである。
また、非水溶性の粉体又は繊維の濃度を０．２質量％〜４．０質量％にするようにしたものである。
また、非水溶性の粉体が、炭酸カルシウムであるようにしたものである。
The skin model for training medical treatment of the present invention is an aqueous solution of polyvinyl alcohol having an average degree of polymerization of 500 to 4000 and a degree of saponification of 95 mol% or more, and a water-insoluble powder having an average particle size of 100 μm or less. It is a gelled mixture of body or fiber.
Further, the concentration of the water-insoluble powder or fiber is adjusted to 0.2% by mass to 4.0% by mass.
Further, the water-insoluble powder is made to be calcium carbonate.
本発明の医療処置の訓練用皮膚モデルのエコー画像の視認性調整方法は、上記いずれか一の医療処置の訓練用皮膚モデルのエコー画像の視認性を非水溶性の粉体又は繊維の濃度により調整するようにしたものである。 The method for adjusting the visibility of the echo image of the training skin model of the medical procedure of the present invention determines the visibility of the echo image of the training skin model of any one of the above by the concentration of the water-insoluble powder or fiber. It is intended to be adjusted.
本発明の超音波ガイド法の穿刺手技訓練方法は、上記いずれか一の医療処置の訓練用皮膚モデルに穿刺し、針先のエコー画像を視認しつつ穿刺手技訓練を行わせるようにしたものである。 In the puncture technique training method of the ultrasonic guide method of the present invention, the puncture technique training is performed by puncturing the skin model for training of any one of the above medical procedures and visually observing the echo image of the needle tip. is there.
本発明の医療処置の訓練用皮膚モデルは、エコーガイド下による穿刺を可能とするものである。これにより、人体の皮膚への穿刺などの医療処置のシミュレーションを行うことができる。また、本発明の医療処置の訓練用皮膚モデルは、ＭＲＩ装置の撮像対象としても利用できるものである。
本発明の医療処置の訓練用皮膚モデルのエコー画像の視認性調整方法によると、穿刺する人体の皮膚のエコー画像に近似するエコー画像を用いて、穿刺手技の訓練を行うことができる。
本発明の超音波ガイド法の穿刺手技訓練方法により、人体の皮膚でも再現できるように穿刺法を訓練することができる。
The skin model for training medical procedures of the present invention enables echo-guided puncture. This makes it possible to simulate medical procedures such as puncturing the skin of the human body. In addition, the skin model for training medical procedures of the present invention can also be used as an imaging target of an MRI apparatus.
According to the method for adjusting the visibility of the echo image of the skin model for training of the medical procedure of the present invention, the puncture technique can be trained by using the echo image that approximates the echo image of the skin of the human body to be punctured.
By the puncture technique training method of the ultrasonic guide method of the present invention, the puncture method can be trained so that it can be reproduced even on the skin of a human body.
本発明は、人体の皮膚の医療処置又は皮膚を通じた医療処置のシミュレーションを実現するものである。 The present invention realizes a simulation of a medical procedure on the skin of the human body or a medical procedure through the skin.
本発明の医療処置の訓練用皮膚モデルを図１に基づいて説明する。図１は、本発明の医療処置の訓練用皮膚モデルの使用状態を表わす図である。図１（ａ）は、人体モデル（模擬人体）の動脈及び静脈に本発明の医療処置の訓練用皮膚モデルを取り付けた状態を表わす図であり、図１（ｂ）は図１（ａ）のＡ−Ａ断面図である。
本発明の医療処置の訓練用皮膚モデルは、医療処置を行う部位の模擬皮膚である。図１において、本発明の医療処置の訓練用皮膚モデル１０は、直方体に形成されているものであり、コンニャクのように弾力性のあるものであり、人体の皮膚に似た質感を有するものである。なお、図１の医療処置の訓練用皮膚モデル１０には、細長い管状の道具（たとえば、ストロー）を差し通して、人体モデルの動脈及び静脈を通すための貫通穴１２を形成している。
本発明の超音波ガイド法の穿刺手技訓練方法を図１に基づいて説明する。人体モデルの動脈と静脈を医療処置の訓練用皮膚モデル１０の貫通穴１２に差し入れ、人体モデルに医療処置の訓練用皮膚モデル１０を取り付ける（図１（ａ）（ｂ））。
医療処置の訓練用皮膚モデル１０（エコーガイド下）に穿刺し、針１４の針先１４ａのエコー画像１６を視認しつつ穿刺手技訓練を行う。エコー画像１６はプローブ１８を通じてモニタに描出される。
The skin model for training the medical procedure of the present invention will be described with reference to FIG. FIG. 1 is a diagram showing a usage state of a skin model for training a medical procedure of the present invention. FIG. 1 (a) is a diagram showing a state in which a skin model for training of the medical procedure of the present invention is attached to arteries and veins of a human body model (simulated human body), and FIG. 1 (b) is a diagram of FIG. It is a cross-sectional view of AA.
The skin model for training the medical procedure of the present invention is a simulated skin of the site where the medical procedure is performed. In FIG. 1, the skin model 10 for training the medical procedure of the present invention is formed on a rectangular parallelepiped, has elasticity like konjac, and has a texture similar to that of human skin. is there. In addition, in the skin model 10 for training of medical procedure of FIG. 1, an elongated tubular tool (for example, a straw) is inserted to form a through hole 12 for passing an artery and a vein of a human body model.
The puncture technique training method of the ultrasonic guide method of the present invention will be described with reference to FIG. The arteries and veins of the human body model are inserted into the through holes 12 of the medical procedure training skin model 10, and the medical procedure training skin model 10 is attached to the human body model (FIGS. 1A and 1B).
The skin model 10 for training of medical procedure (under echo guide) is punctured, and the puncture technique training is performed while visually recognizing the echo image 16 of the needle tip 14a of the needle 14. The echo image 16 is visualized on the monitor through the probe 18.
本発明の医療処置の訓練用皮膚モデルは、平均重合度が５００〜４０００であり、ケン化度が９５モル％以上のポリビニルアルコールの水溶液と、平均粒子径が１００μｍ以下である非水溶性の粉体又は繊維とを混合する混合液をゲル化したものである。
ポリビニルアルコールは、人体の皮膚の弾性に近づける観点から、平均重合度５００〜４０００が好ましく、１０００〜３０００がより好ましい。けん化度は、９５モル％以上が好ましく、９８モル％以上がより好ましい。また、濃度は５〜１５質量％が好ましい。
The skin model for training medical treatment of the present invention is an aqueous solution of polyvinyl alcohol having an average degree of polymerization of 500 to 4000 and a degree of saponification of 95 mol% or more, and a water-insoluble powder having an average particle size of 100 μm or less. It is a gelled mixture of body or fiber.
From the viewpoint of bringing the polyvinyl alcohol closer to the elasticity of the skin of the human body, the average degree of polymerization is preferably 500 to 4000, and more preferably 1000 to 3000. The degree of saponification is preferably 95 mol% or more, more preferably 98 mol% or more. The concentration is preferably 5 to 15% by mass.
非水溶性の粉体は、入手性・安全性・コスト面等の点から、炭酸カルシウム、酸化アルミニウム、二酸化ケイ素、グラファイトの粉体が好ましい。但し、これらの粉体に限定するものではない。 As the water-insoluble powder, powders of calcium carbonate, aluminum oxide, silicon dioxide, and graphite are preferable from the viewpoints of availability, safety, cost, and the like. However, it is not limited to these powders.
非水溶性の繊維は、例えば、綿、麻、セルロース、絹、羊毛などの天然繊維、ナイロン、ポリエステルなどの合成繊維、ガラス繊維、炭素繊維などの無機繊維などが挙げられる。但し、これらの繊維に限定するものではない。
また、繊維として、セルロースを機械処理や化学処理によって平均繊維径が２００ｎｍ以下まで解繊処理したセルロースナノファイバーや、酢酸菌等のバクテリアにより産生されるバクテリアセルロースも利用できる。
Examples of the water-insoluble fiber include natural fibers such as cotton, hemp, cellulose, silk and wool, synthetic fibers such as nylon and polyester, and inorganic fibers such as glass fiber and carbon fiber. However, it is not limited to these fibers.
Further, as fibers, cellulose nanofibers obtained by defibrating cellulose to an average fiber diameter of 200 nm or less by mechanical treatment or chemical treatment, and bacterial cellulose produced by bacteria such as acetobacter can also be used.
本発明の医療処置の訓練用皮膚モデルの良好なエコー画像の視認性を得るため、非水溶性の粉体又は繊維の平均粒子径は１００μｍ以下であることが好ましい。
平均粒子径は、レーザー回折／散乱式粒度分布測定により得られる体積基準の５０％粒子径（メジアン径）である。非水溶性の粉体又は繊維の平均粒子径は、レーザー回折式粒度分布測定装置（マルバーン社製マスターサイザー３０００）により分散媒として水を用いて測定した。
In order to obtain good visibility of the echo image of the skin model for training the medical procedure of the present invention, the average particle size of the water-insoluble powder or fiber is preferably 100 μm or less.
The average particle size is a volume-based 50% particle size (median size) obtained by laser diffraction / scattering particle size distribution measurement. The average particle size of the water-insoluble powder or fiber was measured by using a laser diffraction type particle size distribution measuring device (Mastersizer 3000 manufactured by Malvern) using water as a dispersion medium.
本発明の医療処置の訓練用皮膚モデルは、以下の工程１〜工程３により成形することができる。
（工程１）水を攪拌しながらポリビニルアルコールと非水溶性の粉体又は繊維を加えた混合液を９０〜９５℃に昇温し溶解するまで攪拌することにより、ポリビニルアルコール水溶液と非水溶性の粉体又は繊維を混合する混合液を得る。
なお、本発明の医療処置の訓練用皮膚モデルを用いた医療処置訓練が実際の医療処置の感覚に近いものになるよう、混合液に顔料や染料などの着色剤や抗菌剤や安定剤などの添加剤を加えても良い。但し、添加剤は、エコー画像の視認性を妨げない程度の量にとどめるものとする。
（工程２）混合液を所定の型（成形缶）に流し込み凍結融解することにより、ゲル化させる。人体の皮膚の弾性に近づける観点から、凍結温度は−５℃以下が好ましく、−２０℃以下がより好ましい。凍結時間は、１時間から２０時間が好ましい。融解は、例えば、室温中に静置する、もしくは乾燥機などにより加熱することにより行う。但し、これらの融解方法に限るものではない。
また、人体の部位の皮膚に近似する弾性を得るために、凍結と融解の工程を複数回繰り返して行う。
（工程３）ゲルを型から取り外すことにより、医療処置の訓練用皮膚モデルを得る。
The skin model for training the medical procedure of the present invention can be molded by the following steps 1 to 3.
(Step 1) While stirring water, a mixed solution containing polyvinyl alcohol and water-insoluble powder or fiber is heated to 90 to 95 ° C. and stirred until dissolved, so that the polyvinyl alcohol aqueous solution and the water-insoluble powder or fiber are dissolved. Obtain a mixed solution in which powder or fiber is mixed.
In order to make the medical procedure training using the skin model for medical procedure training of the present invention closer to the feeling of actual medical procedure, a colorant such as a pigment or a dye, an antibacterial agent, a stabilizer, etc. are added to the mixed solution. Additives may be added. However, the amount of the additive shall be limited to the extent that it does not interfere with the visibility of the echo image.
(Step 2) The mixed solution is poured into a predetermined mold (molding can) and freeze-thawed to gel. From the viewpoint of approaching the elasticity of the human skin, the freezing temperature is preferably −5 ° C. or lower, more preferably −20 ° C. or lower. The freezing time is preferably 1 to 20 hours. Melting is performed, for example, by allowing it to stand at room temperature or by heating it with a dryer or the like. However, it is not limited to these melting methods.
Further, in order to obtain elasticity similar to that of the skin of a human body part, the steps of freezing and thawing are repeated a plurality of times.
(Step 3) By removing the gel from the mold, a skin model for training in medical procedure is obtained.
図２は、実験例及び比較例の実験に使用する皮膚モデルへの超音波ガイド法による穿刺を示す図である。実験例１〜１６及び比較例１〜３の皮膚モデル２０に超音波ガイド法により穿刺し、プローブ１８を移動させながらエコー画像１６中の針先１４ａの視認性（見え易さ）を確認する実験を実施した。実験例及び比較例の実験に得たエコー画像１６を図３乃至図２１に示す。図３乃至図２１のエコー画像１６中に表れる輝点が針先１４ａである。また、図３乃至図２１のエコー画像１６は短軸像である。 FIG. 2 is a diagram showing puncture of a skin model used in the experiments of the experimental example and the comparative example by the ultrasonic guide method. An experiment in which the skin models 20 of Experimental Examples 1 to 16 and Comparative Examples 1 to 3 are punctured by an ultrasonic guide method, and the visibility (easiness of visibility) of the needle tip 14a in the echo image 16 is confirmed while moving the probe 18. Was carried out. The echo images 16 obtained in the experiments of the experimental example and the comparative example are shown in FIGS. 3 to 21. The bright spot appearing in the echo image 16 of FIGS. 3 to 21 is the needle tip 14a. Further, the echo images 16 of FIGS. 3 to 21 are short-axis images.
（本実験にて使用した皮膚モデル）
蒸留水に実験例及び比較例の非水溶性の粉体または繊維と、ポリビニルアルコール（日本酢ビ・ポバール株式会社製ＪＣ‐１７ＫＢ、平均重合度１７００、けん化度９９モル％）とを加え、加熱しながら攪拌することによりポリビニルアルコールを溶解し、ポリビニルアルコール１０質量％と実験例及び比較例の非水溶性の粉体または繊維を含む混合液を調製した。調整した混合液を型（成形缶）に流し込み、冷凍庫中で−２０℃にて８時間凍結した後、解凍した。さらに、同様の操作（−２０℃で８時間の凍結の後解凍）を繰り返し、混合液をゲル化した。得られたゲルを型から取り外すことにより実験に使用する皮膚モデル２０を得た。
(Skin model used in this experiment)
Water-insoluble powders or fibers of Experimental Examples and Comparative Examples and polyvinyl alcohol (JC-17KB manufactured by Japan Vam & Poval Co., Ltd., average degree of polymerization 1700, saponification degree 99 mol%) are added to distilled water and heated. Polyvinyl alcohol was dissolved by stirring while stirring, and a mixed solution containing 10% by mass of polyvinyl alcohol and water-insoluble powders or fibers of Experimental Examples and Comparative Examples was prepared. The prepared mixed solution was poured into a mold (molding can), frozen in a freezer at −20 ° C. for 8 hours, and then thawed. Further, the same operation (freezing at −20 ° C. for 8 hours and then thawing) was repeated to gel the mixed solution. The obtained gel was removed from the mold to obtain a skin model 20 to be used in the experiment.
（実験例１〜１１について）
実験例１〜１１では、非水溶性の粉体として平均粒子径１５．９μｍの炭酸カルシウム（和光純薬工業株式会社製）を用いた、粉体の濃度０．０５質量％（実験例１）、０．１質量％（実験例２）、０．２質量％（実験例３）、０．３質量％（実験例４）、０．５質量％（実験例５）、１．０質量％（実験例６）、１．５質量％（実験例７）、２．０質量％（実験例８）、３．０質量％（実験例９）、４．０質量％（実験例１０）、５．０質量％（実験例１１）の各皮膚モデル２０を使用して、穿刺手技における針先１４ａの視認性（針先１４ａの見え易さ）の確認実験を行った。
(About Experimental Examples 1 to 11)
In Experimental Examples 1 to 11, calcium carbonate (manufactured by Wako Pure Chemical Industries, Ltd.) having an average particle diameter of 15.9 μm was used as the water-insoluble powder, and the concentration of the powder was 0.05% by mass (Experimental Example 1). , 0.1% by mass (Experimental Example 2), 0.2% by mass (Experimental Example 3), 0.3% by mass (Experimental Example 4), 0.5% by mass (Experimental Example 5), 1.0% by mass (Experimental Example 6), 1.5% by mass (Experimental Example 7), 2.0% by mass (Experimental Example 8), 3.0% by mass (Experimental Example 9), 4.0% by mass (Experimental Example 10), Using each skin model 20 of 5.0% by mass (Experimental Example 11), a confirmation experiment of the visibility of the needle tip 14a (the visibility of the needle tip 14a) in the puncture procedure was performed.
（実験例１２〜１６について）
実験例１２では、非水溶性の粉体として平均粒子径４９．５μｍの酸化アルミニウム（和光純薬工業株式会社製）を用いた、粉体の濃度０．３質量％の皮膚モデル２０を使用して、穿刺手技における針先１４ａの視認性の確認実験を行った。
実験例１３では、非水溶性の粉体として平均粒子径２７．４μｍのグラファイト（和光純薬工業株式会社製）を用いた、粉体の濃度０．３質量％の皮膚モデル２０を使用して、穿刺手技における針先１４ａの視認性の確認実験を行った。
実験例１４では、非水溶性の粉体として平均粒子径９．１３μｍの二酸化ケイ素（和光純薬工業株式会社製）を用いた、粉体の濃度０．３質量％の皮膚モデル２０を使用して、穿刺手技における針先１４ａの視認性の確認実験を行った。
実験例１５では、非水溶性の繊維として平均粒子径５４．６μｍのセルロース（ＳＩＧＭＡ‐ＡＬＤＲＩＣＨ Ｃｏ．製）を用いた、繊維の濃度０．５質量％の皮膚モデル２０を使用して、穿刺手技における針先１４ａの視認性の確認実験を行った。
実験例１６では、非水溶性の繊維としてセルロースナノファイバー（株式会社スギノマシン製ＢｉＮＦｉ−ｓ（登録商標））を用いた、繊維の濃度０．３質量％の皮膚モデル２０を使用して、穿刺手技における針先１４ａの視認性の確認実験を行った。
(About Experimental Examples 12 to 16)
In Experimental Example 12, a skin model 20 having a powder concentration of 0.3% by mass using aluminum oxide (manufactured by Wako Pure Chemical Industries, Ltd.) having an average particle diameter of 49.5 μm as a water-insoluble powder was used. Then, an experiment was conducted to confirm the visibility of the needle tip 14a in the puncture procedure.
In Experimental Example 13, a skin model 20 having a powder concentration of 0.3% by mass using graphite (manufactured by Wako Pure Chemical Industries, Ltd.) having an average particle diameter of 27.4 μm as a water-insoluble powder was used. , An experiment was conducted to confirm the visibility of the needle tip 14a in the puncture procedure.
In Experimental Example 14, a skin model 20 having a powder concentration of 0.3% by mass using silicon dioxide (manufactured by Wako Pure Chemical Industries, Ltd.) having an average particle diameter of 9.13 μm as a water-insoluble powder was used. Then, an experiment was conducted to confirm the visibility of the needle tip 14a in the puncture procedure.
In Experimental Example 15, a puncture procedure was performed using a skin model 20 having a fiber concentration of 0.5% by mass using cellulose (manufactured by SIGMA-ALDRICH Co.) having an average particle diameter of 54.6 μm as a water-insoluble fiber. An experiment was conducted to confirm the visibility of the needle tip 14a in the above.
In Experimental Example 16, puncture was performed using a skin model 20 having a fiber concentration of 0.3% by mass using cellulose nanofibers (BiNFi-s (registered trademark) manufactured by Sugino Machine Limited) as water-insoluble fibers. An experiment was conducted to confirm the visibility of the needle tip 14a in the procedure.
（比較例について）
比較例１（比較実験）では、非水溶性の粉体又は繊維を混合しない、ポリビニルアルコール（日本酢ビ・ポバール株式会社製ＪＣ‐１７ＫＢ、平均重合度１７００、けん化度９９モル％）の水溶液のみをゲル化した皮膚モデル２０を使用して、穿刺手技における針先１４ａの視認性の確認実験を行った。
比較例２（比較実験）では、非水溶性の粉体として平均粒子径２７．４μｍのグラファイト（和光純薬工業株式会社製）を用いた、粉体の濃度１０質量％の皮膚モデルを使用して、穿刺手技における針先１４ａの視認性の確認実験を行った。本比較例で使用する医療処置の訓練用皮膚モデルの材質は、特許文献１に記載の超音波ファントムの材質とほぼ同じものである。
比較例３では、非水溶性の粉体として平均粒子径１１６μｍの二酸化ケイ素（和光純薬工業株式会社製）を用いた、粉体の濃度０．３質量％の皮膚モデル２０を使用して、穿刺手技における針先１４ａの視認性の確認実験を行った。
(About comparative example)
In Comparative Example 1 (comparative experiment), only an aqueous solution of polyvinyl alcohol (JC-17KB manufactured by Japan Vam & Poval Co., Ltd., average degree of polymerization 1700, saponification degree 99 mol%) without mixing water-insoluble powder or fiber An experiment was conducted to confirm the visibility of the needle tip 14a in the puncture procedure using the gelled skin model 20.
In Comparative Example 2 (comparative experiment), a skin model having a powder concentration of 10% by mass using graphite (manufactured by Wako Pure Chemical Industries, Ltd.) having an average particle diameter of 27.4 μm as a water-insoluble powder was used. Then, an experiment was conducted to confirm the visibility of the needle tip 14a in the puncture procedure. The material of the skin model for training of medical procedure used in this comparative example is almost the same as the material of the ultrasonic phantom described in Patent Document 1.
In Comparative Example 3, a skin model 20 having a powder concentration of 0.3% by mass using silicon dioxide (manufactured by Wako Pure Chemical Industries, Ltd.) having an average particle diameter of 116 μm as a water-insoluble powder was used. An experiment was conducted to confirm the visibility of the needle tip 14a in the puncture procedure.
実験の結果は、表１に示すとおりである。図３乃至図２１は、実験例１〜１６、比較例１〜３の実験により得たエコー画像を表わす図である。図３乃至図２１のエコー画像は、皮膚モデル２０の短軸像である。
穿刺手技における針先の視認性の判断は、図３乃至図２１のエコー画像に基づいて穿刺された針の針先と皮膚モデル部分とが明瞭に区別できるかどうか（針先を明確に確認できるか）で判断した。明瞭に区別できると判断した皮膚モデルには表１に「〇」を、明瞭に区別できないと判断した皮膚モデルには表１に「×」をそれぞれ表記した。
The results of the experiment are shown in Table 1. 3 to 21 are diagrams showing echo images obtained by the experiments of Experimental Examples 1 to 16 and Comparative Examples 1 to 3. The echo images of FIGS. 3 to 21 are short-axis images of the skin model 20.
In the judgment of the visibility of the needle tip in the puncture procedure, whether or not the needle tip of the punctured needle and the skin model part can be clearly distinguished based on the echo images of FIGS. 3 to 21 (the needle tip can be clearly confirmed). Was judged by). The skin model judged to be clearly distinguishable is marked with "○" in Table 1, and the skin model judged to be clearly distinguishable is marked with "x" in Table 1.
本実験によると、実験例で使用した非水溶性の粉体（炭酸カルシウム、酸化アルミニウム、グラファイト、二酸化ケイ素）が所定の濃度である皮膚モデルは、穿刺手技における針先の視認性が認められた（実験例３乃至実験例１０及び図６乃至図１３、実験例１２乃至実験例１４及び図１５乃至図１７）。また、非水溶性の繊維（セルロース、セルロースナノファイバー）についても所定の濃度である皮膚モデルにおいて針先の視認性が認められた（実験例１５、１６及び図１８、１９）。
本実験により、非水溶性の粉体又は繊維の濃度が０．２質量％以上４．０質量％以下であるとき、針先の視認性が認めることが分かった（実験例３乃至実験例１０、実験例１２乃至実験例１６）。
他方、実験例１及び実験例２（粉体の濃度０．２質量％未満の場合）では、皮膚モデル内部が不均一であったため、針先を明確に確認することができなかった（図４及び図５）。
また、実験例１１（粉体の濃度４．０質量％を超える場合）では、針先と皮膚モデル内部とのコントラストが明確ではなかったため、針先が不明瞭であった（図１４）。
According to this experiment, the skin model in which the water-insoluble powder (calcium carbonate, aluminum oxide, graphite, silicon dioxide) used in the experimental example had a predetermined concentration showed visibility of the needle tip in the puncture procedure. (Experimental Examples 3 to 10 and FIGS. 6 to 13, Experimental Examples 12 to 14 and FIGS. 15 to 17). In addition, the visibility of the needle tip was also observed in the skin model having a predetermined concentration for the water-insoluble fibers (cellulose, cellulose nanofibers) (Experimental Examples 15 and 16 and FIGS. 18 and 19).
From this experiment, it was found that the visibility of the needle tip was recognized when the concentration of the water-insoluble powder or fiber was 0.2% by mass or more and 4.0% by mass or less (Experimental Examples 3 to 10). , Experimental Example 12 to Experimental Example 16).
On the other hand, in Experimental Example 1 and Experimental Example 2 (when the powder concentration was less than 0.2% by mass), the needle tip could not be clearly confirmed because the inside of the skin model was non-uniform (FIG. 4). And FIG. 5).
Further, in Experimental Example 11 (when the concentration of the powder exceeds 4.0% by mass), the contrast between the needle tip and the inside of the skin model was not clear, so that the needle tip was unclear (FIG. 14).
比較例１では、針先の特定が困難であった（図３）。
比較例２では、針先は不明瞭であった（図２０）。なお、特許文献１には、混入グラファイトの重量濃度が６〜１３％の間で人体の脂肪、腎臓、肝臓等の超音波に対する減衰係数を近似できると記載されているが、グラファイトの濃度１０質量％の皮膚モデルでは、針先が不明瞭であった。
比較例３（粉体又は繊維が平均粒子径１００μｍを超える場合）では、皮膚モデル内部が不均一であったため、針先を明確に確認することができなかった（図２１）。
In Comparative Example 1, it was difficult to identify the needle tip (Fig. 3).
In Comparative Example 2, the needle tip was unclear (FIG. 20). It should be noted that Patent Document 1 describes that the attenuation coefficient for ultrasonic waves of human fat, kidney, liver, etc. can be approximated when the weight concentration of mixed graphite is between 6 and 13%, but the concentration of graphite is 10 mass. In% of skin models, the tip of the needle was unclear.
In Comparative Example 3 (when the powder or fiber exceeds 100 μm in average particle size), the inside of the skin model was non-uniform, so that the needle tip could not be clearly confirmed (FIG. 21).
本実験により得たエコー画像を比較すると、非水溶性の粉体又は繊維の濃度により皮膚モデルのエコー画像の視認性が変化することが分かった（図６乃至図１３、図１５乃至図１９）。これにより、穿刺する人体の皮膚のエコー画像に近似するエコー画像を用いて、穿刺手技の訓練を行うことができる。 Comparing the echo images obtained in this experiment, it was found that the visibility of the echo image of the skin model changes depending on the concentration of the water-insoluble powder or fiber (FIGS. 6 to 13, 15 to 19). .. As a result, the puncture technique can be trained using an echo image that approximates the echo image of the skin of the human body to be punctured.
本実験において、複数の観察者（実験者）による医療処置の訓練用皮膚モデルの官能評価では、コンニャクのように弾力性があり、皮膚モデルの強度、質感・触感、穿刺、切開などの感触が人体の皮膚に酷似するものであることが分かった。
なお、本実験において、医療処置の訓練用皮膚モデルの強度と濃度の関係について、セルロースナノファイバーの混合濃度によって強度を調整できることが分かった。
In this experiment, in the sensory evaluation of the skin model for training of medical treatment by multiple observers (experimenters), it was elastic like Konyaku, and the strength, texture / tactile sensation, puncture, incision, etc. of the skin model were felt. It turned out to be very similar to the skin of the human body.
In this experiment, it was found that the relationship between the strength and the concentration of the skin model for training of medical procedure can be adjusted by the mixed concentration of cellulose nanofibers.
以上のことから、本発明の医療処置の訓練用皮膚モデルに穿刺し、針先のエコー画像を視認しつつ穿刺手技訓練を行わせることが可能であることが分かった。本発明の医療処置の訓練用皮膚モデルを用いると、人体の皮膚でも再現できるように穿刺法を訓練することができる。たとえば、１）動静脈へカテーテルを挿入をするためのエコーガイドによる穿刺、２）胸腔内の液体貯留の確認及び吸引を行うためのエコーガイドによる穿刺、３）上記１）と２）に付随する穿刺部位付近の皮膚切開、４）皮膚内への液体の投与等について、その医療処置をシミュレーションすることができる。 From the above, it was found that it is possible to puncture the skin model for training of the medical procedure of the present invention and to perform puncture technique training while visually recognizing the echo image of the needle tip. Using the skin model for training medical procedures of the present invention, the puncture method can be trained so that it can be reproduced on the skin of the human body. For example, 1) Echo-guided puncture for inserting a catheter into the arteries and veins, 2) Echo-guided puncture for confirming and aspirating fluid retention in the thoracic cavity, and 3) Accompanying 1) and 2) above. It is possible to simulate the medical procedure for the skin incision near the puncture site, 4) administration of liquid into the skin, and the like.
本発明の医療処置の訓練用皮膚モデルは、人体の表面を覆っている層（血管などの器官を除く、表皮・真皮・皮下組織の構成からなる層に相当するもの）の模擬皮膚であるが、例えば、胸壁（皮膚から壁側胸膜までの部分）のように、皮膚を含む部位のモデルも含む概念である。すなわち、本発明の医療処置の訓練用皮膚モデルは、胸腔内の液体貯留の確認及び吸引を行うための、エコーガイドによる穿刺手技訓練にも利用可能なものである。 The skin model for training of medical treatment of the present invention is a simulated skin of a layer covering the surface of the human body (corresponding to a layer composed of epidermis, dermis, and subcutaneous tissue excluding organs such as blood vessels). , For example, the concept includes a model of a part including the skin, such as the chest wall (the part from the skin to the parietal pleura). That is, the skin model for training the medical procedure of the present invention can also be used for puncture procedure training by an echo guide for confirming and sucking liquid retention in the thoracic cavity.
１０ 医療処置の訓練用皮膚モデル
１４ａ 針先
１６ エコー画像
10 Skin model for training of medical procedure 14a Needle tip 16 Echo image
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| ES2958163A1 (en) * | 2022-07-05 | 2024-02-02 | Consejo Superior Investigacion | Using composite material as an artificial tissue or organ to test the performance of an ultrasound diagnostic device |
| WO2024075482A1 (en) * | 2022-10-07 | 2024-04-11 | デンカ株式会社 | Resin composition for medical simulator and molded product thereof |
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