WO2009062421A1 - Pâte de médicament ultrasonore - Google Patents

Pâte de médicament ultrasonore Download PDF

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Publication number
WO2009062421A1
WO2009062421A1 PCT/CN2008/072219 CN2008072219W WO2009062421A1 WO 2009062421 A1 WO2009062421 A1 WO 2009062421A1 CN 2008072219 W CN2008072219 W CN 2008072219W WO 2009062421 A1 WO2009062421 A1 WO 2009062421A1
Authority
WO
WIPO (PCT)
Prior art keywords
ultrasonic
layer
patch
drug
adhesive
Prior art date
Application number
PCT/CN2008/072219
Other languages
English (en)
French (fr)
Inventor
Qing Wang
Original Assignee
Chongqingshi Shengli Medical Equipment Co., Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Chongqingshi Shengli Medical Equipment Co., Ltd filed Critical Chongqingshi Shengli Medical Equipment Co., Ltd
Priority to JP2010533415A priority Critical patent/JP2011502659A/ja
Priority to AU2008323454A priority patent/AU2008323454B2/en
Priority to RU2010123372/14A priority patent/RU2478001C2/ru
Priority to ES08800731.5T priority patent/ES2562686T3/es
Priority to EP08800731.5A priority patent/EP2213326B1/en
Priority to US12/740,391 priority patent/US20100262070A1/en
Publication of WO2009062421A1 publication Critical patent/WO2009062421A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M35/00—Devices for applying media, e.g. remedies, on the human body
    • A61M35/003—Portable hand-held applicators having means for dispensing or spreading integral media
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0092—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K41/00—Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
    • A61K41/0047—Sonopheresis, i.e. ultrasonically-enhanced transdermal delivery, electroporation of a pharmacologically active agent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007—Drug-containing films, membranes or sheets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M2037/0007—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/04—Skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0004—Applications of ultrasound therapy
    • A61N2007/0013—Fracture healing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0004—Applications of ultrasound therapy
    • A61N2007/0034—Skin treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0073—Ultrasound therapy using multiple frequencies

Definitions

  • the present invention relates to an ultrasonic medical device, and more particularly to an apparatus for introducing a drug into the body through the skin using ultrasonic waves.
  • Injection of drugs requires intravenous or muscle tissue.
  • the presence of wounds is likely to cause infection, and the time during which the drug acts on the lesion through the blood circulation is short, and most of it is excreted, causing waste; and the oral drug is reduced after digestion and absorption by the digestive system.
  • Efficacy, and most drugs have bitter taste, making it difficult for patients to swallow and other shortcomings; therefore, direct penetration of drugs into the lesions through the skin has become a major development direction of drug therapy.
  • Ordinary external administration is to directly place the medicament on the affected part by means of application or wrapping, but the penetration effect of the skin and muscle tissue is poor, which results in a long treatment period and brings a lot of inconvenience to the patient.
  • ultrasonic has the advantages of non-invasive, non-radiative and more than electronic devices.
  • ultrasonic devices for drug penetration through the skin mainly include ultrasonic atomization, heat introduction and vibration introduction, such as Chinese patent application. No. 90103647.1 discloses an ultrasonic liquid permeation apparatus which applies a cloth or tissue paper with a chemical solution to an affected part, and then places an ultrasonic probe thereon and moves left and right, and uses high frequency vibration to achieve a liquid medicine. Infiltrate into the body tissue for treatment purposes. Further, as disclosed in Chinese Patent Application No.
  • an ultrasonic transdermal permeation device an ultrasonic percutaneous transdermal product, and an ultrasonic transdermal permeation method are disclosed, the device specifically introducing a drug that can safely and effectively penetrate the skin.
  • the technology disclosed in the prior patents only uses ultrasound as a tool for drug penetration, and does not consider ultrasound and drugs as a whole system, nor does it propose an integrated, miniaturized implementation.
  • the prior art ultrasonic percutaneous osmosis device has a complicated structure of instruments and equipment, and is sick.
  • the patient is inconvenient to use by himself; the drug is partially separated from the ultrasound, and it is easy to off target to cause damage to the surrounding tissue; and the use of the same probe to treat different patients is likely to cause cross-contamination.
  • the integrated ultrasonic medicine patch proposed by the invention completely solves the above problems, and has low cost and is suitable for mass production and sales.
  • the present invention overcomes the above disadvantages and proposes an ultrasonic patch.
  • the patch has a simple structure, is convenient to use, and is easy to manufacture.
  • the ultrasonic patch comprises a bonding layer as a base layer, a drug layer adjacent to the bonding layer, an ultrasonic transducer generating an ultrasonic signal, a driving unit for providing an electrical signal and driving the ultrasonic transducer to emit an ultrasonic signal, and a coating unit
  • the surface is covered with a wrapper.
  • the bonding layer is a flexible material with good permeability, such as a perforated cloth, and any one side is coated with an adhesive, which can be pasted at one time to avoid cross-contamination.
  • the opposite side of the adhesive coated surface has two surface areas, a first area and a second area.
  • the adhesive layer is further coated with a disposable anti-adhesive layer on one side of the adhesive layer, and the anti-adhesive film is removed during the treatment to adhere the drug patch to the treatment site.
  • the drug layer is prepared by spraying or infiltrating the drug on a highly adsorbable material, and is fixed on the first region of the adhesive layer by pressing and pasting, and the ultrasonic layer is ultrasonically attached to the drug layer. Launch surface.
  • the back side of the ultrasonic transducer is a driving unit, and the driving unit includes an ultrasonic driving circuit and a power source, and the power source has two modes of internal and external.
  • the ultrasonic driving circuit is disposed in a layer on the back of the ultrasonic transducer, electrically connected to the ultrasonic transducer and the ultrasonic driving circuit, and the power is disconnected by using a switching film, the switching film One end is exposed to the patch.
  • a portion of the coating layer completely covers the drug layer, the ultrasonic transducer, and the driving unit, and is fixed on the first region on the bonding layer, and the other portion of the cladding material is combined with the second region on the bonding layer to be arbitrarily bent.
  • the power supply When the power supply is external, it includes an external battery case, battery, power cord, plug, and a fixed socket set on the medicine patch.
  • the battery is placed in the battery box and the plug is connected through the power cord.
  • the fixed socket and the ultrasonic on the medicine stick are attached.
  • the driving circuit and the ultrasonic transducer are electrically connected, and a part of the coating layer is a drug layer, an ultrasonic transducer,
  • the ultra-driving circuit is coated and fixed on the first region of the bonding layer, and the other portion of the cladding material is combined with the second region on the bonding layer to form a bonding edge that can be bent at any time.
  • the plug When used, the plug is inserted into the fixed socket, and the power is plugged. Turn on the drug work.
  • a method of manufacturing the ultrasonic patch including the steps of:
  • the adhesive layer has two surface areas opposite to the surface of the adhesive coated surface, the first area and the second area; the adhesive layer is the bottom layer of the patch of the present invention, Made of a flexible material with good permeability;
  • the drug is sprayed or infiltrated on a highly adsorbable material to form a drug layer;
  • the drug layer is fixed to the first region of the adhesive layer, and the ultrasonic layer of the ultrasonic transducer is attached to the drug layer.
  • the switch film is used to disconnect the power source, and one end of the switch film is exposed to the medicine patch, so that it can be taken out when the user is in use, so that the power source is turned on;
  • a portion of the coating layer integrally covers the drug layer, the ultrasonic transducer, and the driving unit to the first region on the bonding layer, and the other portion of the cladding material is combined with the second region of the bonding layer to be arbitrarily bent. Adhesive edges make it easy to fit the patch on uneven human skin.
  • the advantages of the invention are as follows:
  • the invention combines the ultrasonic and the medicine patch in an ingenious manner, so that the effectiveness of the medicine patch is greatly improved, and at the same time, the medicine patch has the characteristics of lightness and single use, so that the medicine patch can be faster and more Good entry into clinical applications.
  • the invention has the advantages of simple structure, convenient manufacture and convenient use, and can avoid adverse consequences such as infection, pain, fear and the like due to injection medicine.
  • the structure proposed by the present invention makes it possible to use the ultrasonic drug patch like a common drug patch, and solves the key problem that the ultrasonic drug permeation technique cannot enter the clinical application in a large amount.
  • Figure 1 is a schematic view of the structure of the present invention.
  • Fig. 2 is a cross-sectional view showing the first embodiment.
  • Fig. 3 is a cross-sectional view showing the second embodiment.
  • FIG. 4 is a schematic diagram of an external power supply of Embodiment 2.
  • Figure 5 is a schematic view of the adhesive side of the adhesive.
  • Fig. 6 is a schematic view showing another appearance of the adhesive side of the medicine.
  • the superwave patch of the present invention comprises a bonding layer 1, a drug layer 2, an ultrasonic transducer 3, a driving unit 4, and a cladding layer 5.
  • the drug layer 2, the ultrasonic transducer 3, the driving unit 4 are sequentially stacked from the bottom to the top, the cladding layer 5 is coated on the outside of the three layers, and the bonding layer 1 is the base layer.
  • the adhesive layer 1 is the bottom layer of the patch of the present invention, and is made of a flexible material having good permeability.
  • the punched cloth is coated with an adhesive on either side thereof.
  • the opposite side of the adhesive coated surface has two surface areas, a first area 11 and a second area 12, the first area 11 preferably located in the intermediate area for the drug layer 2, the ultrasonic transducer 3,
  • the drive unit 4 is fixed thereto, the second region 12 is preferably an edge region, and the second region is coated with an adhesive and a composite layer.
  • the first region 11 can also be selected in a non-intermediate portion, and the second region 12 is an asymmetrical edge, which is made into a patch to facilitate treatment of a site having special needs.
  • the drug layer 2 is prepared by spraying or infiltrating the drug on a highly adsorbable material.
  • the non-woven fabric is preferably used to infiltrate the liquid drug, and the drug layer is fixed on the first region 11 of the adhesive layer 1, tightly Attached to the drug layer is the ultrasonic emitting surface of the ultrasonic transducer 3.
  • the driving unit 4 includes a power source 41 and an ultrasonic driving circuit 42.
  • the ultrasonic driving circuit 42 is located at the back of the ultrasonic transducer 3.
  • the power source 41 is electrically connected to the ultrasonic driving circuit 42 and the ultrasonic transducer 3, respectively.
  • the switch film 7 is used to turn off the power supply, and one end of the switch film 7 is exposed to the medicine patch, so that it can be taken out when the use is convenient, so that the power source is turned on;
  • a portion of the cladding layer 5 covers the drug layer 2, the ultrasonic transducer 3, and the driving unit 4 integrally fixed to the first region 11 on the bonding layer 1, and the other portion of the cladding material and the second region on the bonding layer 1. 12 is compounded into a bonding edge that can be bent at will, which is convenient for attaching the medicine patch to the surface of uneven human skin.
  • the embodiment includes an anti-adhesive film attached to the side of the adhesive layer coated with the adhesive, which can be Secondary use.
  • the anti-adhesive film is first peeled off, the patch is adhered to the skin surface of the site to be treated through the adhesive layer 1, and then the switch film 7-end exposed to the patch is pulled.
  • the power is turned on, and the ultrasonic transducer 3 is driven by the ultrasonic driving circuit 42 to emit ultrasonic waves in the direction of the drug layer 2, and the drug solution penetrates into the lesion through the adhesive layer 1, the human skin, the tissue, and the like. Release the drug for the purpose of treatment.
  • the bonding edge of the cladding layer 5 and the second region 12 on the bonding layer 1 is bent, but is not limited to the two shapes. Since the medicine patch of the invention is small and simple, it is only necessary to apply the ultrasonic medicine to the skin of the lesion part during the treatment, and the medicine stick can be ablated after the treatment.
  • the present embodiment differs from the embodiment 1 in that the power source 41 in the drive unit 4 is of an external type.
  • the external power source 41 includes a battery case 60, a battery 64, a power cord 63, a plug 62, and a fixed socket 61 disposed on the patch.
  • the battery 64 is placed in the battery case 60 and connected to the plug 62 through the power cord 63 to form an electrical path.
  • the fixed socket 61 on the patch is electrically connected to the ultrasonic driving circuit 42 and the ultrasonic transducer 3.
  • a portion of the cladding layer 5 covers the drug layer 2, the ultrasonic transducer 3, and the ultrasonic driving circuit 42 to the adhesive layer.
  • the first region 11 in the middle of the layer, the other portion of the cladding material and the second region 12 on the bonding layer are combined into a bendable edge which can be bent at any time.
  • the plug 63 is inserted into the fixed socket 64, and the power source can be guided. Pass, medicine work.
  • the ultrasonic transducer can select products with different working frequencies, and the number of ultrasonic transducers is not limited to one, and an appropriate number of ultrasonic transducers can be selected according to actual needs. So that it works at different frequencies. Ultrasonic transducers of different frequencies can work alternately or simultaneously.
  • the power supply on and off of the control transducer is not limited to the manner in which the switching film is used, and other known means may be employed without departing from the scope of the present invention.
  • the present invention also provides a method of making an ultrasonic patch comprising the steps of:
  • the adhesive layer has two surface areas opposite to the surface of the adhesive coated surface, the first area 11 and the second area 12; the adhesive layer 1 is the patch of the present invention
  • the bottom layer is made of a flexible material with good permeability. This embodiment is a perforated cloth, and an adhesive is applied on either side thereof. Secondary paste
  • the drug layer 2, the ultrasonic transducer 3, the driving unit 4 is fixed on the first region 11; the first region 11 is preferably located in the middle region;
  • the second region 12 is preferably an edge region, and the second region may be coated with a bonding agent and a cladding layer.
  • the first region 11 can also be selected at a non-intermediate portion, and the second region 12 is an asymmetrical edge, which is made into a patch to facilitate treatment of a portion with special needs.
  • the drug layer 2 is prepared by spraying or infiltrating the drug on a highly adsorbable material; it is preferable to use a non-woven fabric to infiltrate the liquid drug.
  • the drug layer is fixed on the first region 11 of the adhesive layer 1, and the ultrasonic emission surface of the ultrasonic transducer 3 is adhered to the drug layer.
  • the driving unit 4 includes a power source 41 and an ultrasonic driving circuit 42.
  • the ultrasonic driving circuit 42 is located at the back of the ultrasonic transducer 3.
  • the power source 41 is electrically connected to the ultrasonic driving circuit 42 and the ultrasonic transducer 3, respectively.
  • the switch film 7 is used to turn off the power supply, and one end of the switch film 7 is exposed to the medicine patch, so that it can be taken out when the use is convenient, so that the power source is turned on;
  • a portion of the cladding layer 5 is coated with the drug layer 2, the ultrasonic transducer 3, and the driving unit 4 integrally fixed to the first region 11 on the bonding layer 1, and the other portion of the cladding material and the bonding layer 1
  • the two regions 12 are composited into an adhesive edge which can be bent at will, so that the medicine patch can be attached to the surface of the uneven human skin.
  • the present embodiment includes a release film which adheres to the side of the adhesive layer coated with the adhesive and can be used once.
  • the anti-adhesive film is first peeled off, the patch is adhered to the skin surface of the site to be treated through the adhesive layer 1, and then the switch film 7-end exposed to the patch is pulled.
  • the power is turned on, and the ultrasonic transducer 3 is driven by the ultrasonic driving circuit 42 to emit ultrasonic waves in the direction of the drug layer 2, and the drug solution penetrates into the lesion through the adhesive layer 1, the human skin, the tissue, and the like. Release the drug for the purpose of treatment.
  • the power source 41 in the driving unit 4 can also be externally mounted.
  • the external power source 41 includes a battery case 60, a battery 64, a power cord 63, a plug 62, and a fixed socket 61 disposed on the patch.
  • the battery 64 is placed in the battery case 60 and connected to the plug 62 through the power cord 63 to form an electrical path.
  • the device 3 is electrically connected.
  • a portion of the cladding layer 5 of the embodiment covers the first layer 11 in the middle of the bonding layer, and the other part of the coating material is coated with the drug layer 2, the ultrasonic transducer 3, and the ultrasonic driving circuit 42.
  • the second region 12 on the bonding layer is composited into an adhesive edge which can be bent at any time.
  • the ultrasonic patch of the present invention depends on the treatment needs, depending on the actual condition (such as pharyngitis, bone and joint disease, muscle pain, skin disease, acupuncture treatment of Chinese medicine, etc.) or health care needs (such as beauty, whitening). , wrinkle removal and weight loss, etc.), you can choose various types of drugs to infiltrate and use ultrasound to intervene in the organism.
  • the ultrasonic medicine post disclosed in the various embodiments of the present invention has the characteristics of miniaturization and integration, wherein the size of the ultrasonic transducer and the driving unit is equivalent to the size of a round button battery, and the thickness is only 3 of the thickness of the battery.
  • the volume is only 1/(100 ⁇ 1000) of the existing ultrasonic drug penetration device, and the ultrasonic intensity and duration of the ultrasonic wave fully meet the requirements of drug penetration.

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Description

超声波药贴
本申请要求于 2007 年 11 月 13 日提交中国专利局、 申请号为 200710188165.6, 发明名称为"一种一次性超声波药贴"的中国专利申请的优先 权， 其全部内容通过引用结合在本申请中。
技术领域
本发明涉及超声波医疗设备，具体地说，是一种利用超声波经皮肤向体内 导入药物的设备。
背景技术
目前， 现有的药物治疗通常有三种方式： 注射、 口服以及经皮渗透。 注射 药物需要通过静脉或者肌肉组织，存在创口容易引起感染， 并且药物通过血液 循环作用于病变部位的时间较短， 大部分被排出体外， 造成浪费； 而口服药物 经消化系统的消化吸收后降低了疗效， 并且多数药物都存在味苦，使患者难以 下咽等缺点；因此通过皮肤向体内病变部位直接渗透药物成为药物治疗的一个 主要发展方向。 普通的外部给药是将药剂通过敷或包裹的方式直接置于患部， 但由于皮肤、肌肉组织的渗透效果很差， 使得治疗周期长， 给患者带来诸多不 便。 而随着医学的不断发展， 逐渐出现了一些通过电子、超声等手段向体内导 入药物的医疗设备，有效地提高了人体组织对药物的吸收和治疗效果。 而超声 波具有的无创、无辐射等优点比电子设备更多地为人们所利用，现有技术中通 过皮肤进行药物渗透的超声波设备主要有超声雾化、 热导入以及振动导入等， 如中国专利申请第 90103647.1 号公开了一种超声波药液渗透仪器， 该仪器通 过将沾有药液的布或绵纸敷与患部，再将超声探头置于其上并左右移动， 利用 高频振动来达到使药液渗透到机体组织进行治疗的目的。又如中国专利申请第 03802476.4号公开了一种超声波经皮透过装置，超声波经皮透过配套产品和超 声波经皮透过方法，该装置具体介绍了一种能使药物安全有效地透过皮肤、肌 肉、脂肪到达治疗部位的装置和方法。 并且利用不同频率的超声波来有效的向 不同的部位渗透药物。但是， 已有专利所公开的技术仅仅把超声波作为药物增 透的一种工具，没有把超声波和药物看作是一个整体系统，更没有提出一体化、 小型化具体实现方式。
综上所述，现有技术的超声波经皮渗透装置存在仪器设备结构较复杂， 病 患者不便于自己使用； 药物与超声部分分离， 容易脱靶造成周边组织的损伤； 以及使用同一只探头治疗不同病患的方式容易造成交叉污染等缺点。而本发明 提出的一体化超声波药帖完全解决了以上问题， 并且成本低廉，适合大量生产 和销售。
发明内容
本发明克服了上述缺点， 提出了一种超声波药贴。 该药贴结构简单、使用 方便、 便于制造。
本发明解决其技术问题所采取的技术方案是：
该超声波药贴， 包括作为基层的粘接层， 紧邻粘接层的药物层， 产生超声 波信号的超声换能器，提供电信号及驱动超声换能器发出超声波信号的驱动单 元， 以及包覆在外表面、 将药贴包覆为一体的包覆层。
粘接层是通透性能良好的柔性材料， 如打孔布， 任意一面涂有粘胶剂， 可 一次性粘贴， 避免了交叉污染。 与涂粘胶剂面相反的一面有两个表面区域， 第 一区域和第二区域。
粘接层涂有粘胶剂的一面进一步附着有一次性防粘膜，治疗时将防粘膜揭 去将药贴贴合在治疗部位即可。
药物层采用将药物经喷涂或浸润在吸附性强的材料上制成，通过压紧、粘 贴等多种方式固定在粘接层上第一区域，紧贴药物层的是超声换能器的超声波 发射面。
超声波换能器的背面是驱动单元， 所述驱动单元包括超声驱动电路和电 源， 所述电源有内置和外置两种方式。
当电源内置于药贴时， 与超声驱动电路设置在一层，位于超声换能器的背 面， 与超声换能器及超声驱动电路电连接， 采用开关膜将电源断开， 所述开关 膜的一端外露于药贴。 包覆层的一部分将药物层、超声换能器、 驱动单元完全 包覆后固定在粘接层上第一区域，另一部分包覆材料与粘接层上第二区域复合 成可任意弯折的粘接边， 使用药贴时， 将开关膜抽出， 电源导通药贴工作。
当电源外置时， 包括外置的电池盒、 电池、 电源线、 插头以及设置在药贴 上的固定插座， 电池放置于电池盒内通过电源线接上插头， 药贴上的固定插座 与超声驱动电路及超声换能器电连接，包覆层的一部分将药物层、超声换能器、 超驱动电路包覆固定在粘接层上第一区域，另一部分包覆材料与粘接层上第二 区域复合成可任意弯折的粘接边，使用时将插头插于固定插座上， 电源导通药 贴工作。
与本发明的超声药贴相适应，还提供了制造所述超声药贴的方法， 包括步 骤：
在粘接层上涂粘胶剂， 粘接层与涂粘胶剂面相反的一面有两个表面区域， 第一区域和第二区域； 粘接层是本发明药贴的最底层， 由通透性良好的柔性材 料制成；
将药物层、 超声换能器、 驱动单元固定在第一区域上；
在第二区域上涂覆粘接剂后， 与包覆层复合；
将药物经喷涂或浸润在吸附性强的材料上制成药物层；
将所述药物层固定在粘接层的第一区域上，紧贴药物层的是超声换能器的 超声波发射面。
采用开关膜使电源处于断开状态， 开关膜的一端外露于药贴，便于使用时 将其抽出， 使电源导通；
包覆层的一部分将药物层、超声换能器、驱动单元包覆为一体固定在粘接 层上第一区域，另一部分包覆材料与粘接层上第二区域复合成可任意弯折的粘 接边， 便于将药贴贴合在不平整的人体皮肤表面。
本发明的优点如下： 本发明把超声和药贴巧妙的结合在一起，使药贴的有 效性大大提高， 同时又使药贴具备轻便和一次性使用的性能， 使药贴能更快、 更好的进入临床应用。 本发明结构简单、 便于制造、 使用方便， 可以避免由于 注射用药引起的不良后果， 如感染、 疼痛、 畏惧等。 本发明提出的结构使超声 药贴象普通药贴一样使用成为可能，解决了超声药物渗透技术不能大量进入临 床应用的关键问题。
附图说明
图 1是本发明的结构示意图。
图 2是实施例 1的剖示图。
图 3是实施例 2的剖示图。
图 4是实施例 2外置电源示意图。 图 5药贴粘接边外型示意图。
图 6药贴粘接边另一种外型的示意图。
附图标记说明： 1. 粘接层； 2. 药物层； 3.超声换能器； 4. 驱动单元； 41. 电源； 42.超声驱动电路； 5. 包覆层； 7. 开关膜； 11. 第一区域； 12. 第二区 域； 60. 电池盒； 61.插座； 62. 插头； 63. 电源线； 64.电池。
具体实施方式
以下结合附图，对本发明的结构和所能起到的效果，做进一步地伴细描述。 实施例 1
如图 1所示， 本发明的超波药贴包括粘接层 1、 药物层 2、 超声换能器 3、 驱动单元 4、 包覆层 5。 药物层 2、 超声换能器 3、 驱动单元 4自下向上依次叠 合， 包覆层 5包覆在这三层外， 粘接层 1为基底层。
如图 2所示， 粘接层 1是本发明药贴的最底层， 由通透性良好的柔性材料 制成， 本实施例为打孔布， 在其任意一面上涂粘胶剂， 可一次性粘贴， 与涂粘 胶剂面相反的一面有两个表面区域， 第一区域 11和第二区域 12, 第一区域 11 优选位于中间区域， 用于将药物层 2、 超声换能器 3、 驱动单元 4固定其上， 第二区域 12优选边缘区域， 第二区域可涂覆粘接剂与包覆层复合。 第一区域 11也可以选取在非中间部位， 第二区域 12为不对称边缘， 制成药贴， 以便于 治疗有特殊需求的部位。
药物层 2是药物经喷涂或浸润在吸附性强的材料上制成的，本实施例优选 采用无纺布浸润液体药物， 所述药物层固定在粘接层 1的第一区域 11上， 紧 贴药物层的是超声换能器 3的超声波发射面。
本实施例中驱动单元 4包括电源 41和超声驱动电路 42，超声驱动电路 42 位于超声换能器 3的背面， 电源 41分别与超声驱动电路 42及超声换能器 3 电连接， 电源 41优选电池， 采用开关膜 7使电源处于断开状态， 开关膜 7的 一端外露于药贴， 便于使用时将其抽出， 使电源导通；
包覆层 5的一部分将药物层 2、 超声换能器 3、 驱动单元 4包覆为一体固 定在粘接层 1上第一区域 11 , 另一部分包覆材料与粘接层 1上第二区域 12复 合成可任意弯折的粘接边， 便于将药贴贴合在不平整的人体皮肤表面。
进一步的， 本实施例包括防粘膜， 附着在粘接层涂有粘胶剂的一面， 可一 次性使用。
使用本发明的药贴进行治疗时， 首先将防粘膜揭去， 将药贴通过粘接层 1 粘接在需治疗部位的皮肤表面，然后拉住外露于药贴的开关膜 7—端将其抽出 使电源导通， 超声换能器 3在超声驱动电路 42的驱动下向药物层 2方向发射 超声波， 药液经通透性好的粘接层 1、 人体皮肤、 组织等渗透到病变部位， 释 放药效， 达到治疗的目的。
如图 5和图 6所示， 是包覆层 5与粘接层 1上第二区域 12复合的粘接边 弯折示意图， 但不限于此二种外形。 由于本发明药贴小巧简单， 治疗时只需将 超声波药贴贴于病变部位的皮肤上即可， 治疗后将药贴撕脱即可。
实施例 2
如图 3、 图 4所示， 为了使药贴更小巧， 本实施例不同于实施例 1的地方 在于驱动单元 4中的电源 41采用了外置式。 外置电源 41包括电池盒 60、 电 池 64、 电源线 63、 插头 62以及设置在药贴上的固定插座 61 , 电池 64放置于 电池盒 60内通过电源线 63接上插头 62形成一个电通路， 药贴上的固定插座 61与超声驱动电路 42及超声换能器 3电连接， 本实施例包覆层 5的一部分将 药物层 2、超声换能器 3、超声驱动电路 42包覆固定在粘接层中间的第一区域 11 , 另一部分包覆料与粘接层上第二区域 12复合成可任意弯折的粘接边， 使 用时将插头 63插于固定插座 64上， 电源即可导通， 药贴工作。
对于所属领域的技术人员而言，可以明白，超声换能器可以选用不同工作 频率的产品，超声换能器的数量也不仅仅局限于一个，可以根据实际需要选择 合适数量的超声换能器， 以便于工作于不同的频率。 不同频率的超声换能器可 以交替工作或同时工作。
控制换能器的电源通断不限于使用开关膜的方式，还可以采用其他的公知 手段， 这都没有超出本发明的保护范围。
与前述的两个实施例相适应，本发明还提供了制造超声药贴的方法， 包括 步骤：
300、 在粘接层上涂粘胶剂， 粘接层与涂粘胶剂面相反的一面有两个表面 区域， 第一区域 11和第二区域 12; 粘接层 1是本发明药贴的最底层， 由通透 性良好的柔性材料制成， 本实施例为打孔布， 在其任意一面上涂粘胶剂， 可一 次性粘贴；
301、 将药物层 2、 超声换能器 3、 驱动单元 4固定在第一区域上 11 ; 第 一区域 11优选位于中间区域；
302、在第二区域上涂覆粘接剂后， 与包覆层复合； 第二区域 12优选边缘 区域， 第二区域可涂覆粘接剂与包覆层复合。 第一区域 11也可以选取在非中 间部位， 第二区域 12为不对称边缘， 制成药贴， 以便于治疗有特殊需求的部 位。
303、 将药物经喷涂或浸润在吸附性强的材料上制成药物层 2; 可以优选 采用无纺布浸润液体药物。
304、将所述药物层固定在粘接层 1的第一区域 11上， 紧贴药物层的是超 声换能器 3的超声波发射面。
本实施例中驱动单元 4包括电源 41和超声驱动电路 42，超声驱动电路 42 位于超声换能器 3的背面， 电源 41分别与超声驱动电路 42及超声换能器 3 电连接， 电源 41优选电池， 采用开关膜 7使电源处于断开状态， 开关膜 7的 一端外露于药贴， 便于使用时将其抽出， 使电源导通；
305、 包覆层 5的一部分将药物层 2、超声换能器 3、 驱动单元 4包覆为一 体固定在粘接层 1上第一区域 11 , 另一部分包覆材料与粘接层 1上第二区域 12复合成可任意弯折的粘接边， 便于将药贴贴合在不平整的人体皮肤表面。
进一步的， 本实施例包括防粘膜， 附着在粘接层涂有粘胶剂的一面， 可一 次性使用。
使用本发明的药贴进行治疗时， 首先将防粘膜揭去， 将药贴通过粘接层 1 粘接在需治疗部位的皮肤表面，然后拉住外露于药贴的开关膜 7—端将其抽出 使电源导通， 超声换能器 3在超声驱动电路 42的驱动下向药物层 2方向发射 超声波， 药液经通透性好的粘接层 1、 人体皮肤、 组织等渗透到病变部位， 释 放药效， 达到治疗的目的。
如图 3、 图 4所示， 为了使药贴更小巧， 还可以将驱动单元 4中的电源 41 采用外置式。 外置电源 41包括电池盒 60、 电池 64、 电源线 63、 插头 62以及 设置在药贴上的固定插座 61 , 电池 64放置于电池盒 60内通过电源线 63接上 插头 62形成一个电通路， 药贴上的固定插座 61与超声驱动电路 42及超声换 能器 3电连接， 本实施例包覆层 5的一部分将药物层 2、 超声换能器 3、 超声 驱动电路 42包覆固定在粘接层中间的第一区域 11 , 另一部分包覆料与粘接层 上第二区域 12复合成可任意弯折的粘接边， 使用时将插头 63插于固定插座 64上， 电源即可导通， 药贴工作。
所属领域的技术人员可以明白，本发明的超声药贴根据其治疗需要，视实 际的病情（如咽炎、 骨关节疾病、 肌肉疼痛、 皮肤疾病、 中医穴位治疗等）或 保健需要（如美容、 美白、 除皱和减肥等等）， 可以选择各种类型的药物进行 浸润后，使用超声波将其介入生物体。本发明各个实施例中所公开的超声波药 帖， 具有小型化、 一体化的特点， 其中超声换能器、 驱动单元的尺寸， 与一块 圆形纽扣电池的尺寸相当， 厚度也只有电池厚度的 3 - 4倍， 体积只有现有超 声波药物透入设备的 1/(100 ~ 1000)， 其发出的超声波强度和持续时间完全满 足药物渗透的要求。应用本发明的技术对部分肌肉疼痛和骨伤疼痛患者给镇痛 药治疗， 10 ~ 20分钟后， 就能够获得明显的止痛效果， 比单纯药物达到相同 的止痛效果要快 3 ~ 5倍。
以上对本发明所提供的超声波药贴进行了详细介绍，本文中应用了具体个 例对本发明的原理及实施方式进行了阐述，以上实施例的说明只是用于帮助理 解本发明的方法及其核心思想； 同时， 对于本领域的一般技术人员， 依据本发 明的思想， 在具体实施方式及应用范围上均会有改变之处， 综上所述， 本说明 书内容不应理解为对本发明的限制。

Claims

权 利 要 求
I. 一种超声波药贴， 其特征在于： 包括作为基层的粘接层， 紧邻粘接层 的药物层，产生超声波信号的超声换能器，提供电信号及驱动超声换能器发出 超声波信号的驱动单元， 以及包覆在外表面的包覆层。
2.根据权利要求 1 所述的超声波药贴， 其特征在于： 所述的粘接层是通 透性能良好的柔性材料。
3.根据权利要求 1或 2所述的超声波药贴， 其特征在于： 所述的粘接层 是打孔布。
4.根据权利要求 1或 2所述的超声波药贴， 其特征在于： 所述的粘接层 上， 涂有粘胶剂的一面附有防粘膜。
5.根据权利要求 1 所述的超声波药贴， 其特征在于： 所述的药物层是将 药物经喷涂或浸润在吸附性强的材料上制成。
6.根据权利要求 2所述的超声波药贴， 其特征在于： 所述的柔性材料的 一面涂有粘胶剂； 与涂粘胶剂面相反的一面有两个表面区域， 第一区域和第二 区域。
7.根据权利要求 1 所述的超声波药贴， 其特征在于： 所述包覆层是柔性 材料， 其一部分用于包覆药物层、 超声换能器、 驱动单元， 另一部分复合在粘 接层上第二区域， 形成可任意弯折的粘接边。
8.根据权利要求 1 所述的超声波药贴， 其特征在于： 所述的驱动单元包 括电源和超声驱动电路， 所述电源置于药贴内部或单独外置。
9.根据权利要求 8所述的超声波药贴， 其特征在于： 所述的电源置于药 贴内部， 与超声驱动电路设置为一体， 置于超声换能器的背面， 所述电源与超 声换能器及超声驱动电路电连接， 采用开关膜将电源断开， 所述开关膜的一端 外露于药贴的表面， 使用药贴时将开关膜抽出， 电源导通， 药贴工作。
10.根据权利要求 8所述的超声波药贴， 其特征在于： 所述的电源外置， 包括外置的电池盒、 电池、 电源线、 插头以及设置在药贴上的固定插座， 电池 放置于电池盒内通过电源线接上插头，药贴上的固定插座与超声驱动电路及超 声换能器电连接， 使用时将插头插于固定插座上， 电源导通， 药贴工作。
II.一种制造超声药贴的方法， 其特征在于， 包括： 在粘接层上涂粘胶剂， 粘接层与涂粘胶剂面相反的一面有两个表面区域， 第一区域和第二区域； 粘接层是本发明药贴的最底层， 由通透性良好的柔性材 料制成；
将药物层、 超声换能器、 驱动单元固定在第一区域上；
在第二区域上涂覆粘接剂后， 与包覆层复合；
将药物经喷涂或浸润在吸附性强的材料上制成药物层；
将所述药物层固定在粘接层的第一区域上，紧贴药物层的是超声换能器的 超声波发射面；
采用开关膜使电源处于断开状态， 开关膜的一端外露于药贴，便于使用时 将其抽出， 使电源导通；
包覆层的一部分将药物层、超声换能器、驱动单元包覆为一体固定在粘接 层上第一区域，另一部分包覆材料与粘接层上第二区域复合成可任意弯折的粘 接边， 便于将药贴贴合在不平整的人体皮肤表面。
12、 如权利要求 11所述的方法， 其特征在于， 所述第一区域在非中间部 位， 第二区域为不对称边缘。
PCT/CN2008/072219 2007-11-13 2008-09-01 Pâte de médicament ultrasonore WO2009062421A1 (fr)

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JP2011502659A (ja) 2011-01-27
RU2010123372A (ru) 2011-12-20
CN101143242A (zh) 2008-03-19
CN100560157C (zh) 2009-11-18
ES2562686T3 (es) 2016-03-07
AU2008323454A1 (en) 2009-05-22
RU2478001C2 (ru) 2013-03-27
EP2213326A1 (en) 2010-08-04
AU2008323454B2 (en) 2013-11-14
KR20100087369A (ko) 2010-08-04
US20100262070A1 (en) 2010-10-14
EP2213326B1 (en) 2016-01-27
EP2213326A4 (en) 2011-08-24

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