WO2021098887A1 - 可穿戴柔性超声尿道瘢痕治疗仪 - Google Patents

可穿戴柔性超声尿道瘢痕治疗仪 Download PDF

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WO2021098887A1
WO2021098887A1 PCT/CN2020/134070 CN2020134070W WO2021098887A1 WO 2021098887 A1 WO2021098887 A1 WO 2021098887A1 CN 2020134070 W CN2020134070 W CN 2020134070W WO 2021098887 A1 WO2021098887 A1 WO 2021098887A1
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patch
flexible ultrasonic
urethral
treatment
ultrasound
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PCT/CN2020/134070
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English (en)
French (fr)
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陈方
傅强
贾龙洋
於明明
蔡晓军
谢雪
姚莉
诸晨琳
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上海市第六人民医院
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Priority claimed from CN201922025232.3U external-priority patent/CN211301814U/zh
Priority claimed from CN201911151378.0A external-priority patent/CN112823821A/zh
Application filed by 上海市第六人民医院 filed Critical 上海市第六人民医院
Priority to JP2022530219A priority Critical patent/JP7472283B2/ja
Publication of WO2021098887A1 publication Critical patent/WO2021098887A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N7/02—Localised ultrasound hyperthermia

Definitions

  • urethral scar The formation of urethral scar is the result of a combination of multiple factors. Fibrosis-promoting protein TGF- ⁇ is currently known to be the most closely related and representative growth factor with scar formation. Inflammation, matrix metalloproteinase MMP and other factors also play an important role in the process of scar formation. The formation of urethral scar after urethral surgery is a common complication, which often affects the postoperative recovery of urethral patients, and it has always been a very difficult problem faced by urologists.
  • the clinical treatment of upper urethral scar and urethral stricture mainly includes surgical treatment and drug treatment.
  • Traditional urethral dilation is not only painful, but also difficult to cure.
  • Open surgery includes urethral scar resection, transurethral scar resection and endoplasty, etc.
  • the treatment cost is high, the surgical trauma is large, and there are many complications, such as impotence, penile curvature, etc., and restenosis is prone to occur after the operation.
  • the drugs used to treat urethral scars mainly include triamcinolone acetonide, verapamil, hyaluronic acid, etc.
  • drug treatment has certain effects, it is often used as an adjuvant treatment after surgery, and it is difficult to exert a good effect alone.
  • the method of injecting the drug into the scar is difficult to operate, and multiple injections will increase the pain of the patient.
  • urethral scars The current common treatment for urethral scars is regular urethral dilation after surgery to prevent urethral stricture.
  • the scar tissue For severe urethral stenosis, the scar tissue must be removed by incision of the urethra.
  • Low-frequency ultrasound has anti-inflammatory effects, and early inflammation is an important cause of scar formation.
  • Low-frequency ultrasound can promote the decrease of the expression of the pro-fibrosis protein TGF- ⁇ 1 and the increase of the expression of the anti-fibrosis protein MMP2, which can significantly anti-fibrosis, so it can inhibit the formation of scars.
  • low-frequency ultrasound can stimulate the release of vascular growth factors, thereby accelerating blood vessel formation and wound healing.
  • Chinese Patent CN106390278A discloses an ultrasonic therapeutic apparatus, including an ultrasonic therapeutic patch and a treatment host, wherein the ultrasonic therapeutic patch includes a patch substrate, on which at least one medicine lumen and at least one ultrasonic transducer are arranged; an attachment unit, It is distributed around the bottom of the patch base and is used to stick to the skin surface.
  • the invention has a complex structure and is not flexible, and is mainly used to use ultrasonic waves to penetrate the skin surface. Compared with the invention, the invention has simple structure, convenient use, good flexibility, strong adhesion, and is applied to the treatment of urethral scars. Treatment and/or prevention.
  • Chinese patents CN208599011U and CN107789751A disclose a flexible ultrasound treatment probe array and a two-dimensional ultrasound array treatment belt. Both the ultrasound treatment probe and the ultrasound two-dimensional array treatment belt include a skin-friendly layer, an ultrasound crystal element and a sound-absorbing protective layer. The surface of the skin-friendly layer is provided with grooves for placing ultrasonic crystal elements, and is mainly used in the fields of ultrasonic treatment of fractures and osteoporosis treatment.
  • the ultrasonic treatment probe and the ultrasonic two-dimensional array treatment band include a multi-layer structure, the overall thickness is relatively thick, so that the flexibility is weak, the adhesion is general, and it is necessary to set a fixed bandage to fix it to the treated part, which is similar to that
  • the patch-type flexible ultrasound probe of the present invention is an integrated flexible structure, the chip is built in the flexible material, the overall thickness is thin, the flexibility is better, and the adhesion is strong, and the application field is the treatment of urethral scars and/ Or prevention.
  • Chinese patent CN109758180A discloses a flexible ultrasonic probe, which includes a flexible substrate and an ultrasonic transducer unit, and is applied to ultrasonic diagnosis.
  • the probe of the device of the present invention mainly generates low-frequency ultrasound, and uses low-frequency ultrasound. Mechanical and thermal effects are used for the treatment and/or prevention of urethral scars.
  • the purpose of the present invention is to overcome the problems of the prior art in the treatment and prevention of urethral scars after urethral surgery, and to invent a wearable flexible ultrasonic urethral scar treatment method; at the same time, it solves the problem that conventional ultrasound probes are too hard to effectively fit on the surface of the penis.
  • low-frequency ultrasound has the effects of promoting vascularization, anti-inflammatory, anti-fibrosis and anti-capsular contracture, and can be used to treat and/or prevent urethral scar disease.
  • the application of low-frequency ultrasound in the clinic of urethral scars, and regular low-frequency ultrasound treatment for patients after minimally invasive transurethral surgery, can effectively inhibit the occurrence of pathological scars.
  • the wearable flexible ultrasonic urethral scar treatment instrument of the present invention includes two parts, a patch-type flexible ultrasonic probe and a control end.
  • the patch-type flexible ultrasound probe is attached to the ventral skin surface of the patient’s penis for ultrasound treatment; the control end is connected to the patch-type flexible ultrasound probe and is used to output excitation signals to control all The patch-type flexible ultrasound probe.
  • the patch type flexible ultrasonic probe is provided with one or more sets of chips for transmitting ultrasonic waves to the surface of the patient's skin when the excitation signal output by the control terminal is received.
  • the probe and the control end can be used together through wired transmission.
  • the shape of the patch-type flexible ultrasound probe is rectangular.
  • the chip is a 4 ⁇ 2 rectangular array, and is made of piezoelectric ceramics or single crystal silicon, and has flexibility.
  • the emitting surface of the chip faces the patient's skin surface.
  • the shape of the chip is rectangular, and its thickness is smaller than that of the patch. The thickness of the flexible ultrasonic probe.
  • the center frequency of the piezoelectric ceramic or monocrystalline silicon is 0.4-4 MHz.
  • Electrodes are provided on the upper surface of the wafer, and the electrodes are used to collect signal lines of the wafer.
  • the side of the patch-type flexible ultrasonic probe is provided with a signal line interface, and the control end is connected to the signal line interface through wired transmission to control the patch-type flexible ultrasonic probe.
  • outpatient treatment can be performed several times a week and regular review of urethral healing and urination; therapeutic application is mainly used in the case where urethral scars have been found, and can be used as conservative treatment alone or in conjunction with urethral dilatation Application, for patients with severe scars that have caused obvious stenosis and need surgery, it can also be used in combination with surgery to consolidate the postoperative curative effect.
  • the ultrasound treatment parameters are set through the control terminal, the ultrasound power range is 30mW/cm 2 -1.5W/cm 2 , the ultrasound frequency range is 1MHz-3MHz, and the single treatment time is 5min-30min ,
  • the ultrasound probe needs to be moved regularly during treatment to avoid excessive damage to the tissue due to local heating.
  • the present invention has the following beneficial effects:
  • FIG. 1 Schematic diagram of the wearable flexible ultrasonic urethral scar treatment instrument of the present invention
  • Fig. 2 is a schematic cross-sectional view of a penis applied with a flexible ultrasonic patch of the present invention
  • Figure 3 is a schematic diagram of the structure of the patch-type flexible ultrasonic probe of the present invention.
  • Example 1 belongs to the preventive application of the device of the present invention in postoperative patients. 50 cases of hypospadias who were admitted to the hospital for surgical treatment were selected in the urology department, and the penile dressing was removed after the urethroplasty (usually about 3-5 days after the operation), and the preventive ultrasound treatment was started on the same day.
  • the patch-type flexible ultrasound probe is attached to the surface of the skin here; equipment parameters: power 0.2W/cm 2 , frequency 1MHz, single treatment time 20min (the ultrasound needs to be moved regularly during treatment The probe avoids excessive damage to the tissue by local heating effects).
  • Outpatient treatment is performed 3 times a week, and indicators such as scar recovery, urethral patency, and urinary function are regularly assessed by means of urethral angiography and urodynamics at 2, 4, 6, and 8 weeks after ultrasound treatment.
  • Therapeutic effect After ultrasound treatment with this instrument, it can promote the softening and absorption of existing scars to a certain extent, and can inhibit the formation of new scars, reduce the probability of reoperation, improve urination symptoms, reduce patient pain and improve their lives quality.

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Abstract

一种可穿戴柔性超声尿道瘢痕治疗仪，治疗仪包括贴片式柔性超声探头（1）和控制端（2）。贴片式柔性超声探头（1）采用硅胶材料制成，其中分布有晶片，晶片用于在接收到控制端（2）的激励信号时向皮肤表面发射超声波。治疗仪在使用时只需将贴片式柔性超声探头（1）贴合于患者阴茎腹侧皮肤表面，并通过控制端（2）设置超声的功率和频率，使用方便，无辐射，无痛感，无副作用。解决了超声贴附于阴茎的技术难题，将低频超声技术应用于尿道瘢痕的治疗，属于新领域的技术扩展，有望解决临床上尿道瘢痕的预防和治疗的难题。

Description

可穿戴柔性超声尿道瘢痕治疗仪 技术领域
本发明涉及一种可穿戴柔性超声尿道瘢痕治疗仪，属于泌尿外科术后瘢痕治疗技术领域。
背景技术
尿道瘢痕的形成是一个多因素共同作用的结果。促纤维化蛋白TGF-β是目前已知与瘢痕形成关系最密切、最有代表性的生长因子。炎症、基质金属蛋白酶MMP等因素也在瘢痕形成过程中发挥着重要的作用。尿道手术后尿道瘢痕的形成是常见的并发症，常常影响尿道患者的术后康复，并且也一直是泌尿外科医生面临的十分棘手的问题。
目前临床上尿道瘢痕及尿道狭窄的治疗方法主要包括手术治疗及药物治疗。传统的尿道扩张术不仅痛苦大，而且难以治愈。开放性手术包括尿道瘢痕段切除、经尿道瘢痕旋切内成形术等，治疗成本高，手术创伤大，并发症较多，如阳痿、阴茎下弯等，且术后易发生再狭窄的问题。
随着尿道腔内技术的发展，内镜下冷刀尿道狭窄内切开术、瘢痕汽化电切、双极等离子尿道内切开及尿道瘢痕电切除术、输尿管镜直视下钬激光切开术等多种新方法的使用使得手术效果逐步提高，但每种方法都有其局限性，例如：内镜下尿道内冷刀切开只能放射状切开，不能切除瘢痕组织和很好止血，术后远期效果差，复发率较高；单极高频电刀能切除瘢痕组织，创面整齐，但其温度高，产生较深的热辐射，对尿道周围组织会造成不同程度的热损伤，组织易发生坏死，形成新的纤维瘢痕组织；输尿管镜直视下钬激光切开术仅适用于狭窄较轻的病例，对狭窄段较长且严重病例则难以达到解除梗阻、通畅尿道的目的。目前手术治疗的成功率仍大约保持在75％左右，且容易陷入再手术-再狭窄的怪圈，而且术后常需结合多次尿道扩张术。
治疗尿道瘢痕的药物主要包括曲安奈德、维拉帕米、透明质酸等，药物治疗虽有一定的效果，但常作为手术后的辅助治疗，难以单独发挥良好的作用。药物瘢痕内注射的方法在操作上有一定的难度，而且多次注射会增加病人的痛苦。
尿道瘢痕现有的常用治疗手段为术后定期尿道扩张以防止尿道狭窄，严重狭窄则要通过切开尿道去除瘢痕组织。
近年来研究表明，超声具有促进血管化、抗炎、抗纤维化、抗包膜挛缩、抑制TGF-β表达、促进MMP表达等作用。低频超声具有抗炎作用，而早期炎症反应是瘢痕形成的重要原因。低频超声能够促进促纤维化蛋白TGF-β1的表达下降、抗纤维化蛋白MMP2的表达升高，可以显著地抗纤维化，因此可以抑制瘢痕的形成。此外低频超声可刺激血管生长因子的释放，从而加速血管的生成和伤口愈合。然而当前并没有对超声用于尿道瘢痕的防治作用的报道。
中国专利CN106390278A公开了一种超声治疗仪，包括超声治疗贴片和治疗主机，其中超声治疗贴片包括贴片基底，其上设置至少一个药物管腔和至少一个超声波换能器；贴附单元，分布在所述贴片基底的底部四周，用于贴附在皮肤表面。该发明结构复杂，不具有柔性，主要用于利用超声波将药物渗透进皮肤表面，与之相比，本发明结构简单，使用便捷，柔性较好，贴附性较强，并且应用于尿道瘢痕的治疗和/或预防。中国专利CN208599011U和CN107789751A公开了一种柔性超声治疗探头阵列和一种超声二维阵列治疗带，该超声治疗探头和超声二维阵列治疗带均包括亲肤层、超声晶元和吸声保护层，所述亲肤层表面设置有凹槽，用于放置超声晶元，并且主要应用于骨折超声治疗及骨质疏松治疗领域。该超声治疗探头和超声二维阵列治疗带包括多层结构，整体的厚度较厚，使得可弯曲性变弱，贴附性一般，并且需要设置固定绷带将其固定到被治疗部位，与之相比，本发明的贴片式柔性超声探头为一体式柔性结构，晶片内置在柔性材料中，整体厚度较薄，柔性较好，贴附性较强，并且应用的领域为尿道瘢痕的治疗和/或预防。中国专利CN109758180A公开了一种柔性超声探头，该探头包括柔性基底和超声换能单元，并且应用于超声诊断，与之相比，本发明装置的探头主要产生的是低频超声，并且利用低频超声的机械效应和热效应用于尿道瘢痕的治疗和/或预防。
发明内容
本发明的目的在于克服现有技术针对尿道术后尿道瘢痕治疗与预防的难题，发明了一种可穿戴柔性超声尿道瘢痕治疗方法；同时解决了常规超声探头太硬，无法有效贴合于阴茎表面的问题，发明了一种可穿戴柔性超声尿道瘢痕治疗仪。
研究表明低频超声具有促进血管化、抗炎、抗纤维化及抗包膜挛缩的作用，可应用于治疗和/或预防尿道瘢痕疾病。将低频超声应用于尿道瘢痕临床中，对经尿道微创手术后的患者定期进行低频超声治疗，能够有效地抑制病理性瘢痕的发生。
另外，目前的常规超声探头太硬，存在无法有效贴合于阴茎表面的问题，本发 明同时通过引入高分子复合材料，即将陶瓷阵元分布在硅胶材料中，形成柔性的超声探头。该超声探头适合贴附于阴茎表面，与控制端通过有线传输相配合使用，从而可以得到可穿戴柔性超声尿道瘢痕治疗仪。
本发明的可穿戴柔性超声尿道瘢痕治疗仪包括贴片式柔性超声探头和控制端两部分。所述贴片式柔性超声探头，贴合于患者阴茎腹侧皮肤表面，用于进行超声治疗；所述控制端，与所述贴片式柔性超声探头相连接，用于输出激励信号以控制所述贴片式柔性超声探头。其中，所述贴片式柔性超声探头上设置一组或多组晶片，用于在接收到所述控制端输出的激励信号时向患者皮肤表面发射超声波。探头和控制端可以通过有线传输进行配合使用。
所述贴片式柔性超声探头采用硅胶材料制成，所述晶片分布在所述硅胶材料中。
所述贴片式柔性超声探头的形状为圆形、椭圆形、正方形、长方形、圆角矩形或者不规则形状，其形状可以根据实际需要来进行定制，其厚度为1-5mm。
优选地，所述贴片式柔性超声探头的形状为长方形。
所述晶片为4×2的矩形阵列，并且由压电陶瓷或者单晶硅制成，具有柔性，所述晶片的发射面面向患者皮肤表面，所述晶片的形状为矩形，其厚度小于贴片式柔性超声探头的厚度。
所述压电陶瓷或者单晶硅的中心频率为0.4-4MHz。
所述晶片上表面设置有电极，所述电极用于汇集所述晶片的信号线。
所述贴片式柔性超声探头的侧边设置有信号线接口，所述控制端通过有线传输与所述信号线接口相连接来控制贴片式柔性超声探头。
所述贴片式柔性超声探头产生的超声波的功率为30mW/cm 2-1.5W/cm 2，频率为1MHz-3MHz。
在治疗和/或预防尿道瘢痕疾病时，将贴片式柔性超声探头贴合于阴茎腹侧皮肤处行低频超声治疗。预防性应用主要用于各种会并发尿道瘢痕的尿道手术(如尿道成形术、尿道端端吻合术等)后，于术后拆除阴茎皮肤处的敷料后即可开始行超声治疗，住院期间可以每日治疗一次，出院后可以每周门诊治疗数次并定期复查尿道愈合水平及排尿等情况；治疗性应用主要用于已发现尿道瘢痕的情况下，可以作为保守治疗单独应用或配合尿道扩张一起应用，对于严重瘢痕已导致明显狭窄需行手术治疗的患者也可与手术联合使用巩固术后疗效。
在超声治疗过程中，通过控制端设置超声治疗的参数，超声功率的范围为30mW/cm 2-1.5W/cm 2，超声频率的范围为1MHz-3MHz，并且单次治疗的时间为 5min-30min，治疗时需定时移动超声探头避免局部热效应过重损伤组织。
相比现有技术，本发明具有如下的有益效果：
(1)本发明的可穿戴贴附式低频超声，无辐射，无痛感，无副作用，使用方便；
(2)本发明解决了超声贴附于阴茎的技术难题，将低频超声技术应用于尿道瘢痕的治疗，属于新领域的技术扩展，有望解决临床上尿道瘢痕的预防和治疗的难题，且目前国际上并没有相关产品。
上述说明仅仅是本发明技术方案的概述，为了能够更清楚的了解本发明的技术手段，并可依照说明书的内容予以实施，以下以本发明较佳的实施例，并配合附图进行详细说明。本发明的具体实施方式由以下实施例及其附图详细给出。
附图说明
为了更清楚地说明本发明实施例中的技术方案，下面将对实施例描述中所需要使用的附图作简单地介绍。显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1本发明可穿戴柔性超声尿道瘢痕治疗仪示意图；
图2本发明柔性超声贴片贴敷阴茎横截面示意图；
图3本发明贴片式柔性超声探头结构示意图。
其中，1-贴片式柔性超声探头，2-控制端。
具体实施方式
为了使本发明的目的、技术方案和优点更加清楚，下面结合附图1-3以及具体的实施例对本发明进行清楚、完整的描述。在本发明的描述中，需要说明的是。术语“上”、“中”、“下侧”等指示的方位或者位置关系为基于附图所示的方位或者位置关系，仅仅是为了便于描述本发明和简化描述，而不是指示或者暗示所指的装置或者元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。
如图1-3所示，本实施例中的可穿戴柔性超声尿道瘢痕治疗仪包括贴片式柔性超声探头(1)和控制端(2)两部分。所述贴片式柔性超声探头(1)的形状为长 方形，厚度为2mm，其上设置有压电陶瓷制成的矩形晶片，其下侧设置有信号线接口。所述贴片式柔性超声探头(1)采用硅胶材料制成，所述晶片分布在所述硅胶材料中，两者均具有一定的柔性。所述控制端(2)通过柔性线缆与所述信号线接口相连接来控制所述贴片式柔性超声探头(1)。
实施例1
实施例1属于本发明装置在术后患者预防性方面的应用。选择泌尿外科收住入院需行手术治疗的尿道下裂的患者50例，于尿道成形术后拆除阴茎敷料(一般术后3-5天左右)当天开始预防性行超声治疗，治疗部位：成形尿道段对应的阴茎腹侧皮肤处，将贴片式柔性超声探头贴合于此处皮肤的表面；设备参数：功率0.2W/cm 2、频率1MHz、单次治疗时间20min(治疗时需定时移动超声探头避免局部热效应过重损伤组织)。住院期间每天治疗一次(一般术后住院7-14天)，出院后每周于门诊治疗1-2次，于术后4、8周后评定尿道恢复水平、排尿情况、术后并发症等，统计尿道瘢痕的发生率及瘢痕严重程度。治疗效果：尿道下裂术后，通过采用本预防性超声治疗方法，可以降低术后尿道瘢痕的发生率及严重程度，降低术后并发症发生率，减少术后尿道扩张甚至二次手术给患者带来的痛苦。
实施例2
实施例2属于本发明装置在尿道瘢痕患者临床治疗方面的应用。选择泌尿外科就诊已行各类尿道手术后出现尿道瘢痕并发症的、需要进一步治疗的患者20名，不包括已形成严重尿道狭窄、严重影响排尿而需限期行手术治疗的患者。治疗部位：尿道瘢痕段对应的阴茎腹侧皮肤处，将贴片式柔性超声探头贴合于此处皮肤的表面；超声设备参数：功率0.5W/cm 2、频率1MKHz、单次治疗时间30min(治疗时需定时移动超声探头避免局部热效应过重损伤组织)。门诊每周治疗3次，于超声治疗后2、4、6、8周通过尿道造影、尿流动力学等手段定期评定瘢痕恢复情况、尿道通畅程度及排尿功能等指标。治疗效果：通过本仪器进行超声治疗后，可以在一定程度上促进已有瘢痕的软化、吸收，并能抑制新瘢痕的形成，降低再次手术的概率，改善排尿症状，减少患者痛苦并提高其生活质量。
对所公开的实施例的上述说明，使本领域专业技术人员能够实现或使用本发明。以上所述仅是本发明的优选实施方式，应当指出，对于本领域的技术人员，在不脱离本发明原理的前提下，还可以做出若干改进和补充，这些改进和补充也应当视为本发明的保护范围。对这些实施例的多种修改对本领域的专业技术人员来说将是显 而易见的，本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下，在其它实施例中实现。因此，本发明将不会被限制于本文所示的这些实施例，而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。

Claims (9)

  1. 一种可穿戴柔性超声尿道瘢痕治疗仪，其特征在于，包括：
    贴片式柔性超声探头，贴合于患者阴茎腹侧皮肤表面，用于进行超声治疗；
    控制端，与所述贴片式柔性超声探头相连接，用于输出激励信号以控制所述贴片式柔性超声探头；
    其中，所述贴片式柔性超声探头上设置一组或多组晶片，用于在接收到所述控制端输出的激励信号时向患者皮肤表面发射超声波。
  2. 根据权利要求1所述的可穿戴柔性超声尿道瘢痕治疗仪，其特征在于，所述贴片式柔性超声探头采用硅胶材料制成，所述晶片分布在所述硅胶材料中。
  3. 根据权利要求1或2所述的可穿戴柔性超声尿道瘢痕治疗仪，其特征在于，所述贴片式柔性超声探头的形状为圆形、椭圆形、正方形、长方形、圆角矩形，其厚度为1-5mm。
  4. 根据权利要求1或2所述的可穿戴柔性超声尿道瘢痕治疗仪，其特征在于，所述晶片为4×2的矩形阵列，并且由压电陶瓷或者单晶硅制成，具有柔性，所述晶片的发射面面向患者皮肤表面，所述晶片的形状为矩形，其厚度小于贴片式柔性超声探头的厚度。
  5. 根据权利要求4所述的可穿戴柔性超声尿道瘢痕治疗仪，其特征在于，所述压电陶瓷或者单晶硅的中心频率为0.4-4MHz。
  6. 根据权利要求1或2中任一项所述的可穿戴柔性超声尿道瘢痕治疗仪，其特征在于，所述晶片上表面设置有电极，所述电极用于汇集所述晶片的信号线。
  7. 根据权利要求1所述的可穿戴柔性超声尿道瘢痕治疗仪，其特征在于，所述贴片式柔性超声探头的侧边设置有信号线接口，所述控制端通过有线传输与所述信号线接口相连接来控制贴片式柔性超声探头。
  8. 根据权利要求1、2、5或7中任一项所述的可穿戴柔性超声尿道瘢痕治疗仪，其特征在于，所述贴片式柔性超声探头产生的超声波的功率为30mW/cm 2-1.5W/cm 2，频率为1MHz-3MHz。
  9. 一种可穿戴柔性超声尿道瘢痕治疗方法，其特征在于，所述治疗方法包括以下步骤：
    (1)将贴片式柔性超声探头贴合于患者阴茎腹侧皮肤表面；
    (2)通过控制端设置超声治疗的参数，功率：30mW/cm 2-1.5W/cm 2，频率：1MHz-3MHz，单次治疗时间：5min-30min，治疗时需定时移动超声探头避免局部热效应过重损伤组织，开始超声治疗；
    (3)后续的超声治疗的频次为1次/天-1次/周，治疗的周期为3天-3月；
    (4)超声治疗后定期进行治疗效果的评定。
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