KR20220159203A - Medical precision drug injection and electroporation fusion electrode - Google Patents
Medical precision drug injection and electroporation fusion electrode Download PDFInfo
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- 239000003814 drug Substances 0.000 title abstract description 28
- 229940079593 drug Drugs 0.000 title abstract description 28
- 238000004520 electroporation Methods 0.000 title abstract description 24
- 238000002347 injection Methods 0.000 title abstract description 16
- 239000007924 injection Substances 0.000 title abstract description 16
- 230000004927 fusion Effects 0.000 title abstract description 10
- 239000010409 thin film Substances 0.000 claims abstract description 6
- 238000007639 printing Methods 0.000 claims abstract description 5
- 206010028980 Neoplasm Diseases 0.000 abstract description 17
- 238000000034 method Methods 0.000 abstract description 7
- 230000002441 reversible effect Effects 0.000 abstract description 6
- 239000000463 material Substances 0.000 abstract 1
- 230000000694 effects Effects 0.000 description 6
- 238000011282 treatment Methods 0.000 description 5
- 238000002271 resection Methods 0.000 description 4
- 206010061902 Pancreatic neoplasm Diseases 0.000 description 3
- 210000000170 cell membrane Anatomy 0.000 description 3
- 230000002427 irreversible effect Effects 0.000 description 3
- 208000015486 malignant pancreatic neoplasm Diseases 0.000 description 3
- 201000002528 pancreatic cancer Diseases 0.000 description 3
- 208000008443 pancreatic carcinoma Diseases 0.000 description 3
- 230000005684 electric field Effects 0.000 description 2
- 239000000615 nonconductor Substances 0.000 description 2
- 238000002727 particle therapy Methods 0.000 description 2
- 238000011084 recovery Methods 0.000 description 2
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- 238000002679 ablation Methods 0.000 description 1
- 230000001133 acceleration Effects 0.000 description 1
- 239000002246 antineoplastic agent Substances 0.000 description 1
- 229940041181 antineoplastic drug Drugs 0.000 description 1
- 230000001640 apoptogenic effect Effects 0.000 description 1
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- 238000002560 therapeutic procedure Methods 0.000 description 1
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- 230000000451 tissue damage Effects 0.000 description 1
- 231100000827 tissue damage Toxicity 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0408—Use-related aspects
- A61N1/0412—Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
- A61N1/0416—Anode and cathode
- A61N1/0424—Shape of the electrode
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- 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
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0408—Use-related aspects
- A61N1/0412—Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
- A61N1/0416—Anode and cathode
- A61N1/042—Material of the electrode
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/327—Applying electric currents by contact electrodes alternating or intermittent currents for enhancing the absorption properties of tissue, e.g. by electroporation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36002—Cancer treatment, e.g. tumour
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- 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
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- 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
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0023—Drug applicators using microneedles
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- 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
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0061—Methods for using microneedles
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- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/05—General characteristics of the apparatus combined with other kinds of therapy
- A61M2205/054—General characteristics of the apparatus combined with other kinds of therapy with electrotherapy
Abstract
Description
본 발명은, 비 전도체인 물체에 관을 만들고, 비 전도체 표면에 박막 전극을 프린팅하는 형태의 의료용 정밀 약물주입 및 전기천공 융합 전극에 대한 것이다. The present invention relates to a precision drug injection and electroporation fusion electrode for medical use in the form of making a tube in a non-conductive object and printing a thin film electrode on the non-conductive surface.
지금까지의 종양을 치료하는 방법은 외과적 절제술, 열적 절제술, 항암제 치료, 방사선 치료, 입자 치료술 등이 있다. Methods of treating tumors so far include surgical resection, thermal resection, chemotherapy, radiation therapy, particle therapy, and the like.
외과적 절제술의 경우 광범위한 주변 조직의 적출로 인해 장기조직의 손상이 발생하여 회복 기간이 길고 정상생활이 어려울 수 있다. 열적 절제술은 치료 방법 때문에 종양의 위치에 따라 적용이 제한될 수 있고, 상해로 인한 합병증을 유발할 수 있다. 종양을 정밀하게 사멸시킬 수 있고 부작용이 거의 없어 꿈의 치료술로 알려진 입자 치료술은 양성자, 중성자를 가속하기 위한 입자가속시설 건립에 따른 공간과 비용 문제 및 도입 가능한 국가의 한정으로 기술의 도입에 한계가 있을 수 있으며, 폐 위장 등 지속적 운동이 있는 조직에는 적용이 어렵다.In the case of surgical resection, organ tissue damage occurs due to the removal of extensive surrounding tissues, which can lead to a long recovery period and make it difficult to lead a normal life. Thermal resection may be limited in its application depending on the location of the tumor due to the treatment method, and may cause complications due to injury. Particle therapy, which is known as dream therapy because it can kill tumors precisely and has almost no side effects, has limitations in introducing the technology due to space and cost problems caused by the construction of particle acceleration facilities to accelerate protons and neutrons, and limited countries where it can be introduced. However, it is difficult to apply to tissues with continuous movement, such as the lungs and stomach.
2009년에는 Angiodynamics사의 Nanoknife가 조직사멸 용도로 허가받으며 비가역적 전기천공술(IRE; Irreversible Electroperation)을 개시하였는데, 이는 세포에 고전압의 전기충격을 주어 세포막에 나노 구멍을 만들어 자가사멸(Apoptosis)를 유도하는 것으로, 췌장암을 비롯한 다양한 암치료에 적용할 수 있다. 다양한 암에 대해 이 기기를 적용한 췌장암 1~2기 환자에 대한 임상시험 논문에서 성능과 안정성을 입증하여, 미국 식약처에서 췌장암 3기에 환자들에 대한 임상시험을 허가 받아, 임상시험이 진행 중이며, 차후 다양한 암치료에 적용하기 위한 연구가 진행되고 있다. In 2009, Angiodynamics' Nanoknife was approved for use in tissue killing and irreversible electroporation (IRE) was initiated. As such, it can be applied to the treatment of various cancers including pancreatic cancer. This device was applied to various cancers, demonstrating its performance and safety in clinical trial papers on patients with stage 1 and 2 pancreatic cancer, and was approved by the US Food and Drug Administration for clinical trials on patients with stage 3 pancreatic cancer, and the clinical trial is in progress. Research is being conducted to apply it to various cancer treatments in the future.
그러나, 상기와 같은 비가역 전기천공술만 시행하는 경우 불완전 사멸 문제와 고전압의 전기충격으로 인한 주변 조직 영향 등과 같은 부작용이 보고되고 있으며, 이는 완전사멸을 위해 무조건 충격전압을 높일 수는 없음을 의미하는 것이라 할 수 있다. 즉 기존 비가역적 전기천공술은 높은 순간 전압으로 전극 부위의 조직들에 대해 열적 소작 가능성이 높고, 전극과 거리가 먼 조직의 전기장 형성 에너지가 낮아 종양의 사멸 가능성은 낮아질 수 있다. However, in the case of performing only the irreversible electroporation as described above, side effects such as incomplete death and effects on surrounding tissue due to high voltage electric shock have been reported, which means that the shock voltage cannot be unconditionally increased for complete death. can do. That is, conventional irreversible electroporation has a high possibility of thermal cauterization of tissues in the electrode area with high instantaneous voltage, and the possibility of tumor death may be low because the electric field formation energy of tissues far from the electrode is low.
이에 반하여, 가역적 전기천공은 전기충격 전압을 낮춘 비열적 치료법으로써, 주변 조직의 영향을 최소화할 수 있고 약물주입을 통해 불완전 사멸 문제를 해결할 수 있다. 그러나 현재까지의 가역적 전기천공술은 세포사멸 약물을 종양 부위에 광범위하게 주사한 후 전기천공을 가하는 방식으로, 종양 이외의 주변조직으로 퍼진 항암약물에 의해 부작용이 발생할 수 있으며, 기존 피부 종양에 적용하는 가역적 전기천공술을 심부에 적용할 경우 약물주입을 위해 바늘을 삽입하고 전기천공을 위한 전극을 재삽입하는 과정에서 타겟팅 정밀도가 떨어질 수 있다. On the other hand, reversible electroporation is a non-thermal treatment with lowered electric shock voltage, which can minimize the effect of surrounding tissue and solve the problem of incomplete death through drug injection. However, reversible electroporation to date is a method of applying electroporation after extensively injecting apoptotic drugs into the tumor site. Side effects may occur due to anticancer drugs spreading to surrounding tissues other than the tumor. When reversible electroporation is applied to the deep region, targeting precision may deteriorate during the process of inserting a needle for drug injection and reinserting an electrode for electroporation.
본 발명은 상술한 문제점을 해결하기 위하여 창출된 것으로, 본 발명이 이루고자 하는 기술적 과제는, 심부의 종양에 가역적 전기천공과 최소량의 약물주입으로 종양 제거를 3차원 적으로 시술할 수 있는 의료용 정밀 약물주입 및 전기천공 융합 전극을 제공하는 것에 목적이 있다.The present invention was created to solve the above-mentioned problems, and the technical problem to be achieved by the present invention is a medical precision drug that can perform tumor removal three-dimensionally with reversible electroporation and minimal amount of drug injection into a deep tumor. It is an object to provide implanted and electroporated fusion electrodes.
또한, 본 발명이 이루고자 하는 다른 기술적 과제는, 심부의 종양에 전기천공과 약물주입을 연속적으로 수행하여 주변 조직의 약물 퍼짐을 최소화할 수 있는 의료용 정밀 약물주입 및 전기천공 융합 전극을 제공하는 것에 목적이 있다.In addition, another technical problem to be achieved by the present invention is to provide a medical precision drug injection and electroporation fusion electrode capable of minimizing drug spread in surrounding tissues by continuously performing electroporation and drug injection into a deep tumor. there is
나아가서, 본 발명이 이루고자 하는 또 다른 기술적 과제는, 전기천공을 위한 전기 펄스 신호의 인가 중간에 약물을 주입하여 다양한 시술방법을 제공할 수 있는 의료용 정밀 약물주입 및 전기천공 융합 전극을 제공하는 것에 목적이 있다.Furthermore, another technical problem to be achieved by the present invention is to provide a medical precision drug injection and electroporation fusion electrode that can provide various treatment methods by injecting drugs in the middle of application of an electric pulse signal for electroporation. there is
본 발명의 목적은 비 전도체인 물체에 관을 만들고, 비 전도체 표면에 박막 전극을 프린팅하는 형태의 전극에 대한 것으로, 또한 날카로운 끝단을 통해 바늘처럼 체내에 삽입할 수 있는 전극을 제공하는 것이다. An object of the present invention is to provide an electrode in the form of making a tube in a non-conductive object and printing a thin film electrode on the non-conductive surface, and also to provide an electrode that can be inserted into the body like a needle through a sharp end.
본 발명의 목적은 이상에서 언급한 목적으로 제한되지 않으며, 언급되지 않은 또 다른 목적들은 아래의 기재로부터 본 발명이 속하는 기술 분야에서 통상의 지식을 가진 자에게 명확하게 이해될 수 있을 것이다.The object of the present invention is not limited to the above-mentioned object, and other objects not mentioned will be clearly understood by those skilled in the art from the description below.
상기의 목적을 달성하기 위하여, 본 발명은 일측부가 소정의 깊이로 인체 내부에 삽입되는 투관용 시스; 및 상기 투관용 시스 내부에 위치하되, 상기 투관용 시스의 일측부로부터 돌출되어 약물을 투입하고자 하는 세포막 주변에 위치하는 팁영역을 구비하는 복수개의 니들부재를 포함하고, 상기 팁영역은, 상기 세포막에 나노천공을 형성하는 천공 전극과, 상기 천공 전극 주변에 위치하며 상기 나노천공에 약물을 투입하는 약물방출홀이 형성된 것을 특징으로 하는 의료용 정밀 약물주입 및 전기천공 융합 전극을 제공할 수 있다.In order to achieve the above object, the present invention is a trocar sheath that is inserted into the human body at one side to a predetermined depth; and a plurality of needle members located inside the trocar sheath and having a tip region protruding from one side of the trocar sheath and positioned around a cell membrane to which a drug is to be injected, wherein the tip region comprises the cell membrane It is possible to provide a medical precision drug injection and electroporation fusion electrode, characterized in that a perforated electrode for forming a nanoperforation and a drug release hole positioned around the perforated electrode and injecting a drug into the nanoperforation.
상기 의료용 정밀 약물주입 및 전기천공 융합 전극은, 인체의 정면, 측면 또는 후면 중 둘 이상의 위치에서 인체로 삽입되는 것일 수 있다.The medical precision drug injection and electroporation fusion electrode may be inserted into the human body at two or more positions among the front, side, or rear surface of the human body.
상기 니들부재는, 가요성 있는 비금속 소재로 형성된 것일 수 있다.The needle member may be formed of a flexible non-metallic material.
상기 천공 전극은 상기 팁영역의 외주면을 감싸도록 나선형으로 형성된 것일 수 있다.The perforated electrode may be formed in a spiral shape to surround an outer circumferential surface of the tip region.
상기 천공 전극은 상기 팁영역의 중심축과 평행한 방향으로 외주면에 직선형으로 형성된 것일 수 있다.The perforated electrode may be linearly formed on an outer circumferential surface in a direction parallel to a central axis of the tip region.
상기 니들부재는, 상기 약물방출홀과 연결되어 약물을 제공하는 채널이 중심축을 따라 내부를 관통하며 형성된 것일 수 있다.The needle member may be formed such that a channel connected to the drug release hole and providing the drug passes through the inside along a central axis.
상기 천공 전극은 전기 펄스 신호를 상기 세포막에 인가하여 나노천공을 형성하고, 상기 전기 펄스 신호는, 500V/cm 내지 1500V/cm 의 전계강도와 50㎲ 내지 200㎲ 진폭을 가지는 펄스의 조합인 것일 수 있다.The perforation electrode applies an electrical pulse signal to the cell membrane to form nanoperforations, and the electrical pulse signal may be a combination of pulses having an electric field strength of 500 V/cm to 1500 V/cm and an amplitude of 50 μs to 200 μs. have.
상기 전기 펄스 신호는, 상기 펄스가 8 내지 10개로 구성된 펄스 트레인을 1Hz 간격으로 3분 이내로 인가되는 것일 수 있다.The electric pulse signal may be a pulse train consisting of 8 to 10 pulses applied at intervals of 1 Hz within 3 minutes.
본 발명의 실시예에 따른 의료용 정밀 약물주입 및 전기천공 융합 전극은 심부의 종양에 가역적 전기천공과 최소량의 약물주입으로 종양 제거를 시술할 수 있으며, 심부의 종양에 전기천공과 약물주입을 연속적으로 수행하여 주변 조직의 약물 퍼짐을 최소화할 수 있는 효과가 있다. 나아가서, 전기천공을 위한 전기 펄스 신호의 인가 중간에 약물을 주입하여 다양한 시술방법을 제공할 수 있으며, 기존의 절제술보다 부작용이 적고 정상회복 가능성이 높은 장점이 있다.The medical precision drug injection and electroporation fusion electrode according to an embodiment of the present invention can perform tumor removal with reversible electroporation and minimal amount of drug injection into a deep tumor, and can continuously perform electroporation and drug injection into a deep tumor. This has the effect of minimizing the spread of the drug in the surrounding tissue. Furthermore, it is possible to provide various treatment methods by injecting drugs in the middle of application of an electric pulse signal for electroporation, and has the advantage of having fewer side effects and a higher possibility of normal recovery than conventional ablation.
도 1 및 도 2는 본 발명의 실시예에 따른 의료용 정밀 약물주입 및 전기천공 융합 전극을 나타낸 사시도,1 and 2 are perspective views showing a precision medical drug injection and electroporation fusion electrode according to an embodiment of the present invention;
이하 첨부된 도면을 참조하면서 본 발명에 따른 바람직한 실시예를 상세히 설명하기로 한다. 이에 앞서, 본 명세서 및 청구범위에 사용된 용어나 단어는 통상적이거나 사전적인 의미로 한정해서 해석되어서는 아니 되며, 발명자는 그 자신의 발명을 가장 최선의 방법으로 설명하기 위해 용어의 개념을 적절하게 정의할 수 있다는 원칙에 입각하여, 본 발명의 기술적 사상에 부합하는 의미와 개념으로 해석되어야만 한다.Hereinafter, preferred embodiments according to the present invention will be described in detail with reference to the accompanying drawings. Prior to this, the terms or words used in this specification and claims should not be construed as being limited to the usual or dictionary meaning, and the inventor appropriately uses the concept of the term in order to explain his/her invention in the best way. Based on the principle that it can be defined, it should be interpreted as meaning and concept consistent with the technical spirit of the present invention.
따라서, 본 명세서에 기재된 실시예와 도면에 도시된 구성은 본 발명의 가장 바람직한 일 실시예에 불과할 뿐이고 본 발명의 기술적 사상을 모두 대변하는 것은 아니므로, 본 출원시점에 있어서 이들을 대체할 수 있는 다양한 균등물과 변형예들이 있을 수 있음을 이해하여야 한다.Therefore, since the embodiments described in this specification and the configurations shown in the drawings are only one of the most preferred embodiments of the present invention and do not represent all of the technical ideas of the present invention, various alternatives may be used at the time of this application. It should be understood that there may be equivalents and variations.
본 발명은, 비 전도체인 물체에 관을 만들고, 비 전도체 표면에 박막 전극을 프린팅하는 형태의 전극에 대한 것으로. 또한 날카로운 끝단을 통해 바늘처럼 체내에 삽입할 수 있다.The present invention relates to an electrode in the form of making a tube in a non-conductive object and printing a thin film electrode on the surface of the non-conductor. It can also be inserted into the body like a needle through the sharp tip.
도 1 및 도 2에 도시된 바와 같이, 본 발명은, 비 전도체인 물체에 관을 만들고, 비 전도체 표면에 박막 전극을 프린팅하는 형태의 전극에 대한 것으로. 또한 날카로운 끝단을 통해 바늘처럼 체내에 삽입할 수 있다.As shown in FIGS. 1 and 2, the present invention relates to an electrode in which a tube is made of a non-conductive object and a thin film electrode is printed on the surface of the non-conductor. It can also be inserted into the body like a needle through the sharp tip.
이상과 같이, 본 발명은 비록 한정된 실시예와 도면에 의해 설명되었으나, 본 발명은 이것에 의해 한정되지 않으며 본 발명이 속하는 기술분야에서 통상의 지식을 가진 자에 의해 본 발명의 기술 사상과 아래에 기재될 청구범위의 균등 범위 내에서 다양한 수정 및 변형이 가능함은 물론이다.As described above, although the present invention has been described by the limited embodiments and drawings, the present invention is not limited thereto, and the technical spirit of the present invention and the following by those skilled in the art to which the present invention belongs Of course, various modifications and variations are possible within the scope of equivalents of the claims to be set forth.
Claims (1)
An electrode in the form of making a tube in a non-conductive object and printing a thin film electrode on the non-conductive surface. It can also be inserted into the body like a needle through the sharp tip.
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KR101872408B1 (en) | 2010-03-01 | 2018-06-28 | 이노비오 파마수티컬즈, 인크. | A tolerable and minimally invasive skin electroporation device |
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KR101097511B1 (en) | 2009-08-07 | 2011-12-22 | 고려대학교 산학협력단 | Fixing method of PDMS electrode for MEMS with Polyimide |
KR101872408B1 (en) | 2010-03-01 | 2018-06-28 | 이노비오 파마수티컬즈, 인크. | A tolerable and minimally invasive skin electroporation device |
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