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JP7472283B2 - Wearable flexible ultrasonic urethral scar treatment device - Google Patents

Wearable flexible ultrasonic urethral scar treatment device Download PDF

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JP7472283B2
JP7472283B2 JP2022530219A JP2022530219A JP7472283B2 JP 7472283 B2 JP7472283 B2 JP 7472283B2 JP 2022530219 A JP2022530219 A JP 2022530219A JP 2022530219 A JP2022530219 A JP 2022530219A JP 7472283 B2 JP7472283 B2 JP 7472283B2
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JP2023502773A (en
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チェン,ファン
フー,チーアン
ジア,ロンヤン
ユー,ミンミン
カイ,シャオジュン
シー,シュエ
ヤオ,リー
ジュー,チェンリン
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Shanghai Sixth Peoples Hospital
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00Ultrasound therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
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    • A61N7/02Localised ultrasound hyperthermia

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Description

本発明は、着用可能なフレキシブル超音波尿道瘢痕治療装置に関し、泌尿器外科の術後瘢痕治療の技術分野に属する。
The present invention relates to a wearable, flexible ultrasonic urethral scar treatment device, which belongs to the technical field of postoperative scar treatment in urological surgery.

尿道瘢痕の形成は、複数の要素が協同作用した結果である。線維化促進タンパク質であるTGF-βは、現在既知の瘢痕形成に最も密接し、最も代表的な成長因子である。炎症、マトリックスメタロプロテアーゼMMPなどの要素も、瘢痕形成の過程において重要な作用を果たす。尿道手術後の尿道瘢痕の形成は、よく見られる合併症で、尿道の患者の術後回復に影響することが多く、そしてずっと泌尿器外科医が面する厄介な問題でもある。
現在、臨床において、尿道瘢痕および尿道狭窄の治療方法は、主に、手術治療および薬物治療を含む。従来の尿道拡張術は、苦痛が大きく、そして治癒が困難である。開放性手術は、尿道瘢痕区域切除、経尿道的回転切除内形成術などを含むが、治療コストが高く、手術創傷が大きく、陰萎、陰茎弯曲のような合併症が多く、そして術後再狭窄の問題が生じやすい。
The formation of urethral scarring is the result of the concerted action of several factors. The profibrotic protein TGF-β is the most closely related and representative growth factor currently known to be involved in scarring. Factors such as inflammation and matrix metalloproteinases (MMPs) also play important roles in the scarring process. The formation of urethral scarring after urethral surgery is a common complication that often affects the postoperative recovery of urethral patients and continues to be a vexing problem faced by urological surgeons.
At present, in clinical practice, the treatment methods for urethral scar and urethral stricture mainly include surgical treatment and drug treatment.Traditional urethral dilation is painful and difficult to cure.Open surgery includes urethral scar segment resection, transurethral rotational resection and endoplasty, but it has high treatment costs, large surgical wounds, many complications such as impotence and penile curvature, and is prone to postoperative restenosis.

尿道腔内技術の発展につれ、内視鏡下クライオプロープ尿道狭窄内切開術、瘢痕電気蒸散術、バイポーラプラズマ尿道内切開および尿道瘢痕電気切除術、尿管鏡直視下ホルミウムレーザー切開術などの多くの新たな方法の使用によって手術の効果が次第に向上してきたが、各方法にそれぞれ制限がある。たとえば、内視鏡下尿道内クライオプロープ切開では、放射線状の切開しかできず、瘢痕組織の切除および止血が困難で、術後の長期的な効果が劣り、再発率が高い。モノポーラ高周波電気メスでは、瘢痕組織の切除が可能で、創面がきれいであるが、温度が高く、深い熱放射が生じ、尿道周囲組織に異なる程度の熱損傷を与え、組織が壊死して新たな線維瘢痕組織が形成しやすい。尿管鏡直視下ホルミウムレーザー切開術では、狭窄が軽度の症例のみに適し、狭窄区域が長くて重症の症例には、閉塞を解除し、尿道の通りをよくする目的が実現しにくい。現在、手術治療は、成功率がまだ約75%程度に留まり、かつ再手術-再狭窄のループに陥りやすく、そして術後も数回の尿道拡張術が必要である場合が多い。 With the development of intraurethral techniques, the surgical effect has gradually improved through the use of many new methods such as endoscopic cryoprope incision of urethral stricture, scar electrovaporation, bipolar plasma incision and urethral scar electroresection, and ureteroscope direct holmium laser incision, but each method has its own limitations. For example, endoscopic urethral cryoprope incision can only make radial incisions, making it difficult to remove scar tissue and stop bleeding, resulting in poor long-term postoperative effects and a high recurrence rate. Monopolar high-frequency electric scalpel can remove scar tissue and produce a clean wound surface, but it has a high temperature and deep thermal radiation, which causes different degrees of thermal damage to the tissues around the urethra, making it easy for the tissue to necrotize and form new fibrous scar tissue. Holmium laser incision under ureteroscope direct vision is only suitable for cases with mild stricture, and in cases with long and severe strictures, it is difficult to achieve the purpose of releasing the blockage and improving the passage of the urethra. Currently, the success rate of surgical treatment remains at around 75%, and patients are prone to falling into a loop of reoperation and restenosis, and often require multiple urethral dilation procedures after surgery.

尿道瘢痕を治療する薬物は、主に、トリアムシノロン、ベラパミル、ヒアルロン酸などを含み、薬物治療は、ある程度の効果があるが、術後の補助治療とされることが多く、単独で好適な作用を発揮することが困難である。薬物を瘢痕内注射する方法は、操作においてある程度の難度があり、そして複数の注射が患者の苦痛を増加させる。
尿道瘢痕の既存の通常の治療手段は、尿道狭窄を防止するために、術後の定期的な尿道拡張で、重度の狭窄に尿道を切開して瘢痕組織を除去する必要がある。
The drugs used to treat urethral scar mainly include triamcinolone, verapamil, hyaluronic acid, etc. Drug therapy has some effect, but it is often used as a postoperative adjuvant treatment, and it is difficult to exert a suitable effect by itself. The method of injecting drugs into scar has some difficulty in operation, and multiple injections increase the pain of the patient.
The existing conventional treatment for urethral scarring requires incision of the urethra in severe cases to remove scar tissue, with regular postoperative urethral dilation to prevent urethral stricture.

近年の研究では、超音波は、血管新生の促進、抗炎症、抗線維化、抗被膜拘縮、TGF-β発現の抑制、MMP発現の促進などの作用がある。低周波超音波は、抗炎症作用を有し、また早期の炎症反応は瘢痕形成の要因である。低周波超音波は、線維化促進タンパク質であるTGF-βの発現低下、抗線維化タンパク質であるMMP2の発現向上を促進し、顕著に線維化に抵抗することができるため、瘢痕の形成を抑制することが可能である。また、低周波超音波は、血管成長因子の放出を刺激することで、血管の生成および創口の癒合を加速させる。しかしながら、未だに、超音波の尿道瘢痕に対する予防・治療作用に関する報告がない。 Recent studies have shown that ultrasound has the effects of promoting angiogenesis, anti-inflammatory, anti-fibrotic, anti-capsular contracture, suppressing TGF-β expression, and promoting MMP expression. Low-frequency ultrasound has an anti-inflammatory effect, and early inflammatory reactions are a factor in scar formation. Low-frequency ultrasound promotes the reduction of expression of TGF-β, a pro-fibrotic protein, and the increase of expression of MMP2, an anti-fibrotic protein, and can significantly resist fibrosis, thereby suppressing scar formation. Low-frequency ultrasound also stimulates the release of vascular growth factors, accelerating blood vessel generation and wound healing. However, there have been no reports yet on the preventive or therapeutic effects of ultrasound on urethral scarring.

中国特許CN106390278Aでは、超音波治療パッチおよび治療ホストを含む超音波治療装置であって、超音波治療パッチは、少なくとも一つの薬物チャンバーおよび少なくとも一つの超音波変換器が設けられたパッチ基材と、前記パッチ基材の底部周辺に分布し、皮膚の表面に貼り付けるための粘着ユニットとを含むものが公開された。当該発明は、構造が複雑で、柔軟性がなく、主に超音波による薬物の皮膚の表面への浸透に使用され、それと比べ、本発明は、構造が簡単で、柔軟性が良く、粘着性が強く、そして尿道瘢痕の治療および/または予防に使用される。中国特許CN208599011UおよびCN107789751Aでは、フレキシブル超音波プローブアレイおよび超音波二次元アレイ治療バンドが公開され、当該超音波治療プローブおよび超音波二次元アレイ治療バンドは、いずれも、皮膚接触層、超音波ウェハーおよび吸音保護層を含み、前記皮膚接触層に超音波ウェハーを設けるための溝が設けられ、そして主に骨折の超音波治療および骨粗鬆症治療の分野に使用される。当該超音波治療プローブおよび超音波二次元アレイ治療バンドは、複層の構造を含み、全体の厚さが大きいため、弯曲性が弱く、粘着性が普通で、そして固定包帯を設置してそれを被治療部位に固定する必要があり、それと比べ、本発明のパッチ式フレキシブル超音波プローブは一体式フレキシブル構造で、チップがフレキシブル材料に内蔵され、全体の厚さが小さく、柔軟性が良く、付着性が強く、そして使用の分野が尿道瘢痕の治療および/または予防である。中国特許CN109758180Aでは、フレキシブル超音波プローブであって、フレキシブル基材および超音波変換ユニットを含み、かつ超音波診断に使用されるプローブが公開され、それと比べ、本発明の装置のプローブは主に低周波超音波を発生し、そして低周波超音波の機械的効果および熱効果を利用して尿道瘢痕の治療および/または予防に使用されるものである。 Chinese patent CN106390278A discloses an ultrasonic therapy device including an ultrasonic therapy patch and a therapy host, the ultrasonic therapy patch including a patch substrate provided with at least one drug chamber and at least one ultrasonic transducer, and an adhesive unit distributed around the bottom of the patch substrate for attaching to the surface of the skin. The invention has a complex structure and is not flexible, and is mainly used for the penetration of drugs into the surface of the skin by ultrasound, whereas the present invention has a simple structure, good flexibility, strong adhesion, and is used for the treatment and/or prevention of urethral scars. Chinese patent CN208599011U and CN107789751A disclose a flexible ultrasonic probe array and an ultrasonic two-dimensional array therapy band, both of which include a skin contact layer, an ultrasonic wafer, and a sound-absorbing protective layer, and the skin contact layer is provided with a groove for placing the ultrasonic wafer, and are mainly used in the fields of ultrasonic treatment of fractures and osteoporosis treatment. The ultrasonic treatment probe and ultrasonic two-dimensional array treatment band have a multi-layer structure, a large overall thickness, poor curvature, normal adhesion, and require a fixed bandage to be installed to fix it to the treatment site. In comparison, the patch-type flexible ultrasonic probe of the present invention has an integrated flexible structure, a tip is embedded in a flexible material, a small overall thickness, good flexibility, strong adhesion, and is used in the treatment and/or prevention of urethral scars. Chinese patent CN109758180A discloses a flexible ultrasonic probe, which includes a flexible substrate and an ultrasonic conversion unit, and is used for ultrasonic diagnosis. In comparison, the probe of the device of the present invention mainly generates low-frequency ultrasound and utilizes the mechanical and thermal effects of low-frequency ultrasound to treat and/or prevent urethral scars.

本発明の目的は、既存技術の尿道術後の尿道瘢痕の治療と予防における難題を克服することにあり、着用可能なフレキシブル超音波尿道瘢痕治療方法を発明し、同時に、通常の超音波プローブが硬すぎ、有効に陰茎の表面に順応できないという問題を解決し、着用可能なフレキシブル超音波尿道瘢痕治療装置を発明した。
研究では、低周波超音波は、血管新生の促進、抗炎症、抗線維化および抗被膜拘縮の作用を有し、尿道瘢痕疾患の治療および/または予防に使用することができる。低周波超音波を尿道瘢痕の臨床に応用し、尿道最小侵襲手術後の患者に対して定期的に低周波超音波治療を行うと、有効に病理的瘢痕の発生を抑制することができる。
また、現在の通常の超音波プローブは硬すぎ、有効に陰茎の表面に順応できない問題があり、本発明は、同時に高分子複合材料を導入し、すなわち、セラミックアレイ素子をシリカゲル材料に分布させることで、フレキシブルな超音波プローブを形成する。当該超音波プローブは、適切に陰茎の表面に貼り付け、制御端と有線伝達を介して合わせて使用することで、着用可能なフレキシブル超音波尿道瘢痕治療装置が得られる。
The purpose of the present invention is to overcome the difficulties in the treatment and prevention of urethral scarring following urethral surgery in the existing technology, and invent a wearable flexible ultrasonic urethral scarring treatment method; at the same time, it solves the problem that the normal ultrasonic probe is too stiff and cannot effectively conform to the surface of the penis, and invents a wearable flexible ultrasonic urethral scarring treatment device.
Research has shown that low-frequency ultrasound has the effects of promoting angiogenesis, anti-inflammatory, anti-fibrotic and anti-capsular contracture, and can be used to treat and/or prevent urethral scar disease. The clinical application of low-frequency ultrasound to urethral scarring, and regular low-frequency ultrasound treatment for patients after minimally invasive urethral surgery can effectively inhibit the development of pathological scarring.
In addition, the current conventional ultrasonic probe is too hard and cannot effectively conform to the surface of the penis, so the present invention simultaneously introduces a polymer composite material, that is, ceramic array elements are distributed in a silica gel material to form a flexible ultrasonic probe, which can be appropriately attached to the surface of the penis and used in conjunction with the control end through wired transmission to obtain a wearable flexible ultrasonic urethral scar treatment device.

課題を解決する手段Means for solving the problem

本発明の着用可能なフレキシブル超音波尿道瘢痕治療装置は、パッチ式フレキシブル超音波プローブおよび制御端の2部分を含む。前記パッチ式フレキシブル超音波プローブは、患者の陰茎腹側の皮膚の表面に貼り付け、超音波治療を行うためのもので、前記制御端は、前記パッチ式フレキシブル超音波プローブと接続し、励起信号を出力して前記パッチ式フレキシブル超音波プローブを制御するためのものである。ここで、前記パッチ式フレキシブル超音波プローブには、前記制御端が出力する励起信号を受け取ると、患者の皮膚の表面に超音波を発射するように、一組または複数組のチップが設けられている。プローブと制御端は有線伝達を介して合わせて使用してもよい。 The wearable flexible ultrasonic urethral scar treatment device of the present invention includes two parts: a patch-type flexible ultrasonic probe and a control end. The patch-type flexible ultrasonic probe is attached to the surface of the skin on the ventral side of the patient's penis to perform ultrasonic treatment, and the control end is connected to the patch-type flexible ultrasonic probe and outputs an excitation signal to control the patch-type flexible ultrasonic probe. Here, the patch-type flexible ultrasonic probe is provided with one or more sets of tips so as to emit ultrasonic waves to the surface of the patient's skin when it receives the excitation signal output by the control end. The probe and the control end may be used together via wired transmission.

前記パッチ式フレキシブル超音波プローブはシリカゲル材料で製造され、前記チップは前記シリカゲル材料の中に分布する。
前記パッチ式フレキシブル超音波プローブの形状は、円形、楕円形、正方形、長方形、角丸矩形または不規則形状で、その形状は実際の必要によって決定され、その厚さが1-5 mmである。
好適に、前記パッチ式フレキシブル超音波プローブの形状は長方形である。
前記チップは、4×2の矩形アレイで、かつ圧電セラミックまたは単結晶シリコンで製造され、柔軟性を有し、前記チップの発射面が患者の皮膚の表面に面し、前記チップの形状が矩形で、その厚さがパッチ式フレキシブル超音波プローブの厚さよりも小さい。
前記圧電セラミックまたは単結晶シリコンの中心周波数は0.4-4 MHzである。
前記チップの表面には、前記チップの信号線をまとめる電極が設けられている。
前記パッチ式フレキシブル超音波プローブの横側に信号線の接続ポートが設けられ、前記制御端は有線伝達を介して前記信号線の接続ポートと接続してパッチ式フレキシブル超音波プローブを制御する。
前記パッチ式フレキシブル超音波プローブが発生する超音波は、出力が30 mW/cm2-1.5 W/cm2で、周波数が1 MHz-3 MHzである。
The patch type flexible ultrasonic probe is made of a silica gel material, and the tip is distributed in the silica gel material.
The shape of said patch type flexible ultrasonic probe is circular, elliptical, square, rectangular, rounded rectangular or irregular, the shape of which is determined according to actual needs, and the thickness of which is 1-5 mm.
Preferably, the patch type flexible ultrasonic probe has a rectangular shape.
The tips are in a 4x2 rectangular array and are made of piezoelectric ceramic or single crystal silicon, are flexible, the emitting surface of the tips faces the surface of the patient's skin, the tips are rectangular in shape, and the thickness of the tips is less than the thickness of a patch-type flexible ultrasound probe.
The center frequency of the piezoelectric ceramic or single crystal silicon is 0.4-4 MHz.
An electrode for collecting signal lines of the chip is provided on the surface of the chip.
A signal line connection port is provided on the side of the patch type flexible ultrasonic probe, and the control end is connected to the signal line connection port through wired transmission to control the patch type flexible ultrasonic probe.
The ultrasonic waves generated by the patch-type flexible ultrasonic probe have an output of 30 mW/cm 2 -1.5 W/cm 2 and a frequency of 1 MHz -3 MHz.

尿道瘢痕疾患の治療および/または予防時、パッチ式フレキシブル超音波プローブを陰茎腹側の皮膚に貼り付けて低周波超音波治療を行う。予防的使用は、主に、尿道瘢痕が併発する様々な尿道手術(たとえば尿道形成術、尿道端々吻合術など)後に使用され、術後に陰茎の皮膚にある被覆材を除くと、超音波治療を始め、入院中は毎日1回治療してもよく、退院後は毎週外来で数回治療して定期的に尿道の癒合レベルおよび排尿などの状況をチェックしてもよい。治療的使用は、主に、尿道瘢痕が既に見られた場合に使用され、保守的治療として単独で使用してもよく、尿道拡張と合わせて使用してもよく、重度の瘢痕で既に明らかな狭窄になって手術治療が必要な患者にも手術と合わせて使用して術後の治療効果を強化することができる。 In the treatment and/or prevention of urethral scar disease, a patch-type flexible ultrasound probe is attached to the ventral skin of the penis to perform low-frequency ultrasound treatment. Preventive use is mainly used after various urethral surgeries (e.g. urethroplasty, end-to-end urethral anastomosis, etc.) that are accompanied by urethral scarring. After removing the covering material on the skin of the penis after surgery, ultrasound treatment is started, and treatment may be performed once a day during hospitalization, and after discharge, treatment may be performed several times a week in the outpatient clinic to regularly check the urethral adhesion level and urination status. Therapeutic use is mainly used when urethral scarring has already been observed, and may be used alone as a conservative treatment or in combination with urethral dilation. It can also be used in combination with surgery to enhance the postoperative treatment effect in patients who have already developed obvious stricture due to severe scarring and require surgical treatment.

超音波治療の過程において、制御端で超音波治療のパラメーターを設置し、超音波の出力の範囲が30 mW/cm2-1.5 W/cm2で、超音波の周波数の範囲が1 MHz-3 Mhzで、そして一回の治療の時間が5 min-30 minで、治療時は局部の過剰な熱効果による組織損傷が避けられるように定期的に超音波プローブを移動させる必要がある。 During the ultrasonic treatment process, the ultrasonic treatment parameters are set at the control end, the ultrasonic power range is 30 mW/ cm2-1.5 W/ cm2 , the ultrasonic frequency range is 1 MHz-3 Mhz, and the treatment time is 5 min-30 min. During treatment, the ultrasonic probe needs to be moved periodically to avoid tissue damage caused by local excessive heat effect.

既存技術と比べ、本発明は以下のような有益な効果を有する。
(1)本発明の着用可能なパッチ式低周波超音波は、輻射がなく、痛感がなく、副作用がなく、使用しやすい。
(2)本発明は、超音波の陰茎への貼り付けの技術難題を解決し、低周波超音波技術を尿道瘢痕の治療に利用し、新な分野の技術的拡張になり、臨床における尿道瘢痕の予防と治療の難題を解決することが期待され、そして現在世界中に関連製品はまだない。
上記説明は本発明の技術方案の概要に過ぎず、より明瞭に本発明の技術手段を理解し、そして明細書の内容に従って実施することができるように、以下、本発明の好適な実施例で、図面を合わせて詳しく説明する。本発明の具体的な実施形態は、以下の実施例およびその図面で示される。
Compared with existing technologies, the present invention has the following beneficial effects:
(1) The wearable patch type low frequency ultrasound of the present invention has no radiation, no pain, no side effects, and is easy to use.
(2) The present invention solves the technical problem of attaching ultrasound to the penis, and uses low-frequency ultrasound technology to treat urethral scarring. It is expected to be a technological expansion in a new field and solve the difficult problem of preventing and treating urethral scarring in clinical practice, and there are currently no related products in the world.
The above description is merely a summary of the technical solution of the present invention, in order to make the technical means of the present invention more clearly understood and to be able to implement the present invention according to the content of the specification, the preferred embodiments of the present invention will be described in detail below with reference to the drawings. Specific embodiments of the present invention are shown in the following examples and their drawings.

以下、より明瞭に本発明の実施例における技術方案を説明するために、実施例の記述に必要な図面を簡単に紹介する。当然、以下の記述における図面は、本発明の一部の実施例に過ぎず、当業者には、創造的労働をすることなく、これらの図面からほかの図面を得ることができる。 In order to more clearly explain the technical solutions in the embodiments of the present invention, the drawings necessary for the description of the embodiments are briefly introduced below. Of course, the drawings in the following description are only some of the embodiments of the present invention, and those skilled in the art can derive other drawings from these drawings without creative labor.

図1は、本発明の着用可能なフレキシブル超音波尿道瘢痕治療装置の概略図である。FIG. 1 is a schematic diagram of a wearable flexible ultrasonic urethral scar treatment device of the present invention. 図2は、本発明のフレキシブル超音波パッチが陰茎に貼り付けられた場合の断面概略図である。FIG. 2 is a cross-sectional schematic diagram of the flexible ultrasound patch of the present invention when applied to the penis. 図3は、本発明のパッチ式フレキシブル超音波プローブの構造概略図である。 ここで、1はパッチ式フレキシブル超音波プローブで、2は制御端である。3 is a structural schematic diagram of the patch-type flexible ultrasonic probe of the present invention, in which 1 is the patch-type flexible ultrasonic probe and 2 is the control end.

以下、本発明の目的、技術方案および利点がより明瞭にわかるように、図面1-3および具体的な実施例を合わせ、本発明を明瞭に、完全に記述する。本発明の記述において、以下の点を説明することが必要である。用語「上」、「中」、「下側」などで示される方位または位置関係は、図面で示される方位または位置関係に基づいたもので、本発明の記述および記述の簡略化のためのものに過ぎず、示される装置または素子に特定の方位がある、特定の方位で構成および操作する必要があることを指示または示唆するものではないため、本発明に対する制限として理解されない。 In the following, the present invention will be clearly and completely described with reference to drawings 1-3 and specific examples so that the objectives, technical solutions and advantages of the present invention can be more clearly understood. In describing the present invention, it is necessary to explain the following points. The orientations or positional relationships indicated by the terms "upper", "middle", "lower", etc. are based on the orientations or positional relationships shown in the drawings, and are merely for the purpose of describing and simplifying the description of the present invention, and do not indicate or suggest that the devices or elements shown have a specific orientation or need to be configured and operated in a specific orientation, and therefore should not be understood as limitations on the present invention.

図1-3に示すように、本実施例における着用可能なフレキシブル超音波尿道瘢痕治療装置は、パッチ式フレキシブル超音波プローブ(1)および制御端(2)の2部分を含む。前記パッチ式フレキシブル超音波プローブ(1)は、形状が長方形で、厚さが2 mmで、その上に圧電セラミックで製造された矩形チップが、その下側に信号線の接続ポートが設けられている。前記パッチ式フレキシブル超音波プローブ(1)はシリカゲル材料で製造され、前記チップは前記シリカゲル材料の中に分布し、両者はいずれもある程度の柔軟性がある。前記制御端(2)はフレキシブル配線を介して前記信号線の接続ポートと接続して前記パッチ式フレキシブル超音波プローブ(1)を制御する。 As shown in Figure 1-3, the wearable flexible ultrasonic urethral scar treatment device in this embodiment includes two parts: a patch-type flexible ultrasonic probe (1) and a control end (2). The patch-type flexible ultrasonic probe (1) is rectangular in shape and 2 mm thick, with a rectangular tip made of piezoelectric ceramic on top and a signal line connection port on the bottom. The patch-type flexible ultrasonic probe (1) is made of silica gel material, and the tip is distributed in the silica gel material, and both have a certain degree of flexibility. The control end (2) is connected to the signal line connection port through a flexible wiring to control the patch-type flexible ultrasonic probe (1).

実施例1
実施例1は、本発明の装置の術後の患者の予防的使用である。泌尿器外科で入院して手術治療される尿道下裂の患者50例を選択し、尿道形成術後に陰茎の被覆材が撤去された(一般的に術後3-5日程度)当日から予防的な超音波治療を行い、治療部位は形成尿道区域に相応する陰茎腹側の皮膚で、パッチ式フレキシブル超音波プローブを当該皮膚の表面に貼り付け、装置のパラメーターは出力0.2 W/cm2、周波数1 MHz、一回治療時間20 minであった(治療時は局部の過剰な熱効果による組織損傷が避けられるように定期的に超音波プローブを移動させる必要がある)。入院中は毎日1回治療し(一般的に術後7-14日入院)、退院後は毎週外来で1-2回治療し、術後4、8週間後に尿道の回復レベル、排尿状況、術後合併症などを評価し、尿道瘢痕の発生率および瘢痕の重篤度を統計した。治療効果:尿道下裂の術後、本予防的超音波治療方法を利用することで、術後の尿道瘢痕の発生率および重篤度を低下させ、術後合併症の発生率を低下させ、術後尿道拡張ひいては二次手術による患者への苦痛を減少させることができる。
Example 1
Example 1 is the preventive use of the device of the present invention in patients after surgery. 50 hypospadias patients who were hospitalized and treated in the urological surgery department were selected, and preventive ultrasound treatment was performed from the day when the covering material of the penis was removed after urethroplasty (generally about 3-5 days after surgery). The treatment area was the skin on the ventral side of the penis corresponding to the formed urethra area, and a patch-type flexible ultrasound probe was attached to the surface of the skin. The parameters of the device were output 0.2 W/ cm2 , frequency 1 MHz, and treatment time 20 min per session (during treatment, the ultrasound probe needs to be moved periodically to avoid tissue damage caused by excessive heat effect in the local area). During hospitalization, treatment was performed once a day (generally hospitalized for 7-14 days after surgery), and after discharge, treatment was performed once or twice a week in the outpatient department. After 4 and 8 weeks after surgery, the urethra recovery level, urination situation, postoperative complications, etc. were evaluated, and the incidence rate of urethral scarring and the severity of scarring were statistically calculated. Treatment effect: After surgery for hypospadias, the use of this preventive ultrasound treatment method can reduce the incidence and severity of postoperative urethral scarring, reduce the incidence of postoperative complications, and reduce the pain suffered by patients due to postoperative urethral dilation and therefore secondary surgery.

実施例2
実施例2は、本発明の装置の尿道瘢痕患者の臨床治療における使用である。泌尿器外科で診療を受けて様々な尿道手術を行われた後に尿道瘢痕合併症が発生し、さらなる治療が必要な患者20名を選択したが、重度の尿道狭窄が生じ、排尿に大きく影響してすぐに手術治療が必要な患者が含まれなかった。治療部位は尿道瘢痕区域に相応する陰茎腹側の皮膚で、パッチ式フレキシブル超音波プローブを当該皮膚の表面に貼り付け、超音波装置のパラメーターは出力0.5 W/cm2、周波数1 MHz、一回治療時間30 minであった(治療時は局部の過剰な熱効果による組織損傷が避けられるように定期的に超音波プローブを移動させる必要がある)。外来で毎週3回治療し、超音波治療後2、4、6、8週で尿道造影、尿流動態学などの手段によって定期的に瘢痕の回復状況、尿道の通り具合および排尿機能などの指標を評価した。治療効果:本装置で超音波治療を行った後、ある程度で既存の瘢痕の軟化、吸収を促進し、そして新たな瘢痕の形成を抑制し、再手術の確率を低下させ、排尿症状を改善し、患者の苦痛を減少して生活品質を向上させることができる。
Example 2
Example 2 is the use of the device of the present invention in the clinical treatment of patients with urethral scars. 20 patients who had undergone various urethral surgeries in the urological surgery department and developed urethral scar complications and required further treatment were selected, but no patients who had severe urethral strictures that significantly affected urination and required immediate surgical treatment were included. The treatment site was the skin on the ventral side of the penis corresponding to the urethral scar area, and a patch-type flexible ultrasound probe was attached to the surface of the skin. The parameters of the ultrasound device were output 0.5 W/ cm2 , frequency 1 MHz, and treatment time 30 min per session (the ultrasound probe should be moved periodically during treatment to avoid tissue damage caused by excessive local heat effects). Treatment was performed three times a week in the outpatient clinic, and indicators such as scar recovery, urethral passage and urination function were regularly evaluated by means of urethrography, urodynamics, etc. at 2, 4, 6, and 8 weeks after ultrasound treatment. Treatment effect: After ultrasonic treatment with this device, it can soften and promote the absorption of existing scars to a certain extent, inhibit the formation of new scars, reduce the probability of reoperation, improve urinary symptoms, reduce the patient's pain and improve their quality of life.

公開された実施例の上記説明は、当業者が本発明を実現または使用できるようにするものである。上記は本発明の好適な実施形態に過ぎず、当然、当業者には、本発明の原理を逸脱しない限り、少し改良および補充ができ、これらの改良および補充も本発明の保護範囲と見なされる。これらの実施例に対する多くの変更は当業者にとって当然で、本明細書で定義された一般的な原理は、本発明の趣旨または範囲を超えなければ、他の実施例で実現することができる。そのため、本発明は本明細書で示されたこれらの実施例に限定されず、本明細書で開示された原理と新規な特徴と一致する一番広い範囲に当たる。 The above description of the disclosed embodiments is intended to enable a person skilled in the art to realize or use the present invention. The above is merely a preferred embodiment of the present invention, and of course, those skilled in the art may make minor improvements and supplements without departing from the principles of the present invention, and these improvements and supplements are also considered to be within the scope of protection of the present invention. Many modifications to these embodiments will be obvious to those skilled in the art, and the general principles defined herein may be realized in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention is not limited to these embodiments shown in the present specification, but is accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (7)

着用可能なフレキシブル超音波尿道瘢痕治療装置であって、
患者の陰茎腹側の皮膚の表面に貼り付け、超音波治療を行うためのパッチ式フレキシブル超音波プローブと、
前記パッチ式フレキシブル超音波プローブと接続し、励起信号を出力して前記パッチ式フレキシブル超音波プローブを制御するための制御端とを含み、
ここで、前記パッチ式フレキシブル超音波プローブには、前記制御端が出力する励起信号を受け取ると、患者の皮膚の表面に超音波を発射するように、一組または複数組のチップが設けられており、
前記チップは、4×2の矩形アレイで、かつ圧電セラミックまたは単結晶シリコンで製造され、柔軟性を有し、前記チップの発射面が患者の皮膚の表面に面し、前記チップの形状が矩形で、その厚さがパッチ式フレキシブル超音波プローブの厚さよりも小さいことを特徴とする、前記装置。
A wearable flexible ultrasonic urethral scar treatment device , comprising:
A patch-type flexible ultrasound probe for attaching to the surface of the skin on the ventral side of the patient's penis to perform ultrasound treatment;
a control terminal connected to the patch type flexible ultrasonic probe and configured to output an excitation signal to control the patch type flexible ultrasonic probe;
Wherein, the patch-type flexible ultrasonic probe is provided with one or more sets of tips, so as to emit ultrasonic waves to the surface of the patient's skin when receiving an excitation signal outputted by the control end ;
The device is characterized in that the tips are in a 4x2 rectangular array and are fabricated from piezoelectric ceramic or single crystal silicon, are flexible, the emitting surface of the tips faces the surface of the patient's skin, the tips are rectangular in shape, and the thickness of the tips is less than the thickness of a patch-type flexible ultrasound probe.
前記パッチ式フレキシブル超音波プローブはシリコーン材料で製造され、前記チップは前記シリコーン材料の中に分布することを特徴とする請求項1に記載の着用可能なフレキシブル超音波尿道瘢痕治療装置。 The wearable flexible ultrasonic urethral scar treatment device of claim 1 , characterized in that the patch-type flexible ultrasonic probe is made of silicone material, and the tip is distributed within the silicone material. 前記パッチ式フレキシブル超音波プローブの形状は、円形、楕円形、正方形、長方形、角丸矩形で、その厚さが1-5 mmであることを特徴とする請求項1または2に記載の着用可能なフレキシブル超音波尿道瘢痕治療装置。 The wearable flexible ultrasonic urethral scar treatment device of claim 1 or 2 , characterized in that the shape of the patch-type flexible ultrasonic probe is circular, elliptical, square, rectangular, or rounded rectangular, and its thickness is 1-5 mm. 前記圧電セラミックまたは単結晶シリコンの中心周波数は0.4-4 MHzであることを特徴とする請求項に記載の着用可能なフレキシブル超音波尿道瘢痕治療装置。 The wearable flexible ultrasonic urethral scar treatment device of claim 1 , characterized in that the center frequency of the piezoelectric ceramic or single crystal silicon is 0.4-4 MHz. 前記チップの上側表面に電極が設けられ、前記電極は前記チップの信号線をまとめるためのものであることを特徴とする請求項1または2に記載の着用可能なフレキシブル超音波尿道瘢痕治療装置。 The wearable flexible ultrasonic urethral scar treatment device of claim 1 or 2, characterized in that an electrode is provided on the upper surface of the chip, the electrode being for consolidating the signal lines of the chip . 前記パッチ式フレキシブル超音波プローブの横側に信号線の接続ポートが設けられ、前記制御端は有線伝達を介して前記信号線の接続ポートと接続してパッチ式フレキシブル超音波プローブを制御することを特徴とする請求項1に記載の着用可能なフレキシブル超音波尿道瘢痕治療装置。 The wearable flexible ultrasonic urethral scar treatment device of claim 1, characterized in that a signal line connection port is provided on the side of the patch-type flexible ultrasonic probe, and the control end is connected to the signal line connection port via wired transmission to control the patch-type flexible ultrasonic probe . 前記パッチ式フレキシブル超音波プローブが発生する超音波は、出力が30 mW/cm2-1.5 W/cm2で、周波数が1 MHz-3 MHzであることを特徴とする請求項1、2、またはに記載の着用可能なフレキシブル超音波尿道瘢痕治療装置。 The wearable flexible ultrasonic urethral scar treatment device of claim 1, 2, 4 or 6 , characterized in that the ultrasonic waves generated by the patch-type flexible ultrasonic probe have an output of 30 mW/ cm2-1.5 W/ cm2 and a frequency of 1 MHz-3 MHz.
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