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KR19990028365A - 전기외과 수술기구 - Google Patents

전기외과 수술기구 Download PDF

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KR19990028365A
KR19990028365A KR1019970709681A KR19970709681A KR19990028365A KR 19990028365 A KR19990028365 A KR 19990028365A KR 1019970709681 A KR1019970709681 A KR 1019970709681A KR 19970709681 A KR19970709681 A KR 19970709681A KR 19990028365 A KR19990028365 A KR 19990028365A
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electrode
tissue
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니겔 마크 고블
콜린 챨즈 오웬 고블
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니겔 마크 고블
자이러스 메디칼 리미티드
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
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    • A—HUMAN NECESSITIES
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
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    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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    • A61B2018/126—Generators therefor characterised by the output polarity bipolar
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
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Abstract

본 발명은 전기전도성 유체매질의 존재하에서 조직치료(예컨데, "수중 외과술")에 이용되며 기구축과 이 축의 말단에 위치하는 전극 조립체를 포함하는 전기외과적 수술기구에 관한 것이다. 전극 조립체는 조직치료전극(11)과, 절연수단(15)에 의하여 상기 조직치료전극으로부터 전기적으로 절연된 복귀전극(12)를 포함한다. 상기 조직치료전극(11)은 기구의 최외곽 말단에 노출되어 있으며, 복귀전극(12)은 절연체(15)에 의하여 상기 조직치료전극의 노출말단과 간격을 두고 배치된 유체접촉면을 갖는다. 기구는 추가로, 사용할 때 조직치료 전극과 복귀전극간의 전기회로를 완성시키는 전기전도성 유체경로를 확정할 수 있도록 전기전도성 유체를 상기 조직치료 전극의 노출된 말단부위로 주입하는 주입수단을 추가로 포함한다.

Description

전기외과 수술기구
내시경 전기 수술은 신체의 공동내 조직의 처리에 유용하며, 일반적으로 팽창 매질의 존재하에 실시된다. 팽창 매질이 액체인 경우, 이것은 일반적으로 수중 전기 수술로 언급되며, 작동 부위에서 액체중에 잠긴 처리 전극 또는 전극들을 구비한 전기 수술 기구를 이용하여 생체조직을 처리하는 전기수술을 의미한다. 액체 매질이 부적합한, 복강경 또는 위장병학적 수술의 경우와 같은, 더욱 큰 체적의 팽창가능한 체강내에서 내시경 수술이 실시되는 경우는 일반적으로 가스 매질이 사용된다.
수중 수술은 일반적으로 내시경 기술을 이용하여 실시되는데, 여기서 내시경 자체는 전극의 통로를 위한 도관(일반적으로 워킹채널(working channel)로 언급됨)을 제공한다. 선택적으로는, 내시경은 전극 설치 수단을 포함하기위해 (절제경에서와 같이) 특별히 적합하게 되거나, 일반적으로 트라이앵글레이션(triangulation)으로 언급되는, 내시경과 관련된 각도에서 개별적 접근수단을 경유하여 체강내로 전극이 도입된다. 기술내에서의 이들 변형은 수술적 특이성에 따라 하위분류될 수 있으며, 여기서 기술의 각각은 특정 체강에 대한 접근루트가 주어진 특정 장점을 갖는다. 자궁의 자궁내막강을 접근하기 위한 자궁경관, 또는 전립선 및 방광을 접근하기 위한 요도와 같은, 천연 신체개구를 통해 체강에 접근되는 경우, 내장 워킹채널을 갖춘, 또는 절제경과 같은 특징의 것인 내시경이 일반적으로 사용된다. 자궁내막강내의 사용을 위해 특별히 설계된 내시경은 자궁경으로 언급되며, 요로내의 사용을 위해 설계된 것들은 방광경, 요도경 및 절제경을 포함한다. 경요도 절제술이나 전립선의 기화의 방법은 티유알피(TURP)와 이비에이피(EVAP)로 각각 공지되어 있다. 내시경이 통과할 자연적인 신체 개구가 없는 경우는, 일반적으로 트라이앵글레이션 기술이 이용된다. 일반적으로 트라이앵글레이션은 무릎과 어깨와 같은 관절강에 대한 수중 내시경 수술시 이용된다. 본 방법에 사용된 내시경은 일반적으로 관절경이라 언급된다.
전기수술은 일반적으로 단극성 장치든지 양극성(bipolar) 장치를 이용하여 실시된다. 단극성 전기수술에 있어서, 활성(active)전극은 작동부분에서 이용되며, 전도성 복귀(return)판은 환자 피부에 고착된다. 이러한 배열로, 전류가 활성전극으로부터 환자 조직을 경유하여 외부 복귀전극으로 통과한다. 환자가 회로의 상당한 부분을 나타내므로, 환자 조직의 저항성 전류제한 및, 수중 전기수술의 경우에 있어서, 혈액이나 기타 체액의 존재에 의해 부분적으로 전도성이 되는 체액 매질에 의한 전력손실을 보충하기 위해서 입력전력이 높아야한다(전형적으로 150 내지 250 와트). 심각한 피부화상을 발생할 수 있는, 복귀전극에서 발생하는 조직가열 때문에, 단극성 배열과 고전력을 이용하는 것은 또한 위험하다. 또한 장치와 체강내로의 도입점에서의 환자 조직 사이의 정전결합의 위험도 존재한다.
체강에서의 외과수술을 수행할 때, 살아있는 구조가 대상 부위에 아주 근접하여 있는 경우가 흔히 있고, 이들 구조는 전기수술 효과의 부차적인 확산에 의하여 파괴된다. 또한, 단극성 전기수술을 사용할 경우의 문제는, 작동 전압이 환자의 조직의 저항성 전류 한계를 극복하거나, 적용 전극의 탄화를 극복하기 위하여 상승된다는 것이다. 인접하는 구조에의 직접 결합에 의하거나 또는 절연체의 틈을 통한 아크(arc)는 내시경의 좁은 시야밖에서 우발적인 조직 손상을 일으킬 수 있다. 또한, 신체 공동으로의 입구 점에서 기구와 환자의 조직간에 용량성 결합의 위험이 있어서, 전기수술 에너지가 입구 점에의 조직에 결합될 수 있다. 이 결합된 에너지는 종종 화상을 일으키기에 충분하다. 내시경 과정중의 단극성 전기 수술의 이러한 위험들은 현재 충분히 인식되어 있고, 양극성 외과수술의 채택을 유도해 왔다.
양극성 전기수술에 있어서, 한쌍의 전극(활성전극과 복귀전극)이 조직 적용부위에서 함께 사용된다. 고주파 전류가 전극간 부분에 제한되게 하는 두 전극의 상대적 근접때문에 본 배열은 안전성의 관점에서 장점을 지닌다. 그러나 효과의 정도는 두 전극간 거리에 직접적으로 관련되어 있으며; 극히 소형의 전극이 요구되는 적용에 있어서, 전극간 이격이 매우 작아지며, 그것에 의해 조직효과와 출력전력이 제한된다. 전극의 추가적 분리의 이격은 적용부위의 상을 종종 어둡게 할 것이며, 두 전극의 조직과의 직접 접촉을 강화하기 위해서, 수술적 기술에 있어서 변형을 필요로 할 것이다.
양극성 탐침의 기본 설계에 많은 변형이 있다. 예를 들면 미국특허 명세서 4706667호는 기본적인 설계의 것을 기술하며, 즉 절단목적의 경우 복귀전극과 활성전극의 접촉면적 비율이 7:1보다 크며 20:1보다 작다. 본 범위는 단지 절단 전극구성에 관한 것이다. 양극성장치가 건조나 응고를 위해 이용되는 경우는, 두 전극의 접촉면적 비율이 약 1:1로 감소되어, 조직과 전극간 접촉에서 발생하는 차동 전기적 스트레스를 피하도록 한다.
복귀 전극과 조직간의 전기적 접합은 생리 식염수와 같은 전도성 용액에 의하여 조직을 젖게 함에 의하여 유지될 수 있다. 단극성 및 양극성 탐침 장치들 모두 수술부위의 세척을 주목적으로 하는 흡입 및 급수 수단을 흔히 제공한다. 이러한 경우에, 활성 전극은, 노출된 전극에 의한 조직의 기계적 손상의 위험 없이 조직과 덮개의 직접적인 접촉을 가능하게 하도록 급수부 덮개의 내부에 들어가 있도록 설치된다. 덮개내에 들어가 있도록 설치된 전극이나, 식염수의 통과는 어떠한 외과 수술적인 효과도 발생시키지 않는다. 2차적인 장점으로서, 이 장치는, 조직의 젖음이 접촉 임피던스를 감소시키도록 한다.
설계에 있어서 명백한 제한중 하나는 바늘이 조직내에 완전히 묻혀 복귀전극이 회로를 완성할 수 있도록 해야 한다는 것이다. 또다른 것은 방향의 문제로서, 조직 표면과의 이상적 수직 접촉으로부터의 적용 각도에 있어서의 상대적으로 작은 변화일지라도 접촉 면적 비율을 변화시킬 것이며, 따라서 수술 효과가 복귀전극과의 접촉하는 조직내에서 발생할 수 있다.
기술자들은 전도성 액체나 기체성 매질을 사용하여 수중의 전기 수술에 적합한 양극성 기구를 발전시켜왔다. 유체 매질의 존재하의 조직의 치료를 위한 이 전기수술 기구는 핸드피스(handpiece)를 가진 기구 본체, 기구축, 및 상기 축의 한쪽 말단에 전극 조립체를 포함한다. 전극 조립체는, 기구의 최말단 단부에 노출된 조직 치료 전극, 및 조직 치료 전극으로부터 전기적으로 절연되고, 전극 치료 전극의 노출된 부분으로부터 중앙에 가까운 쪽으로 떨어져 설치된 유체 접촉부를 가지는 복귀 전극을 포함한다. 기구의 사용할 때, 조직 치료 전극은 치료되는 조직에 대고, 조직 치료 전극의 노출 부분으로부터 중앙에 가까운 쪽으로 떨어진 복귀 전극은 조직으로부터 보통으로 떨어지게 하여 조직과 유체 매질을 통하여 조직 치료 전극으로부터 전기수술 전류 루프를 형성하는 역할을 한다. 이 전기수술 기구는 본 출원인의 출원중인 영국 특허 출원 제9512889.8호의 명세서에 기재되어 있다.
이 기구의 전극 구조는, 전도성 팽창 매질과 결합하여 단극성 또는 양극성 전기 수술에서의 문제점을 크게 해결한다. 특히, 입력 전원 레벨은 단극성 장치에서 일반적으로 필요한 것(전형적으로 100와트)보다 훨씬 낮다. 더욱이, 그 전극들 간의 상대적으로 큰 간격 때문에, 전형적인 양극성 장치에 비교하여, 향상된 효과의 깊이가 얻어진다.
이 유형의 전기수술 기구는 식염수에서 주로 사용되도록 설계되어 있고, 그래서 공기중이나 가스 충전된 작동 환경에서는 사용될 수 없다.
본 발명은, 전기전도성 유체 매질의 존재하에 조직의 치료를 위한 전기 외과적 수술기구, 그러한 기구를 포함하는 전기외과적 수술장치, 및 그러한 기구에서 사용되는 전극에 관한 것이다.
도 1은 본 발명에 대응하여 구성된 전기외과기구를 보인 도면이고,
도 2는 도 1의 기구로 사용하기 위한 전기외과기구의 첫번째 형태의 말단부의 개략 수직단면도이고,
도 3은 도 1의 기구로 사용하기 위한 전기외과기구의 두 번째 형태의 개략 수직 단면도이다.
본발명의 목적은, 공기 중 또는 가스 충전된 환경에서, 체액중에서, 또는 기구의 말단부 주위에 전도성 유체 환경의 형성에 의한 조직내의 삽입에 의하여 사용될 수 있는, 급수가 되는 양극성 전기 수술 기구를 제공하는 것이다.
본발명은 전기 전도성 유체의 존재하에 조직의 치료를 위한 전기 수술 기구를 제공한다. 상기 기구는 기구 축 및 상기 축의 일단에 설치된 전극 조립체를 포함하며, 상기 전극 조립체는 조직 치료 전극 및 절연 부재에 의하여 조직 치료 전극으로부터 전기적으로 절연된 복귀전극을 포함한다. 상기 조직 치료 전극은 상기 기구의 최단부에 노출되어 있고, 복귀 전극은 절연 부재에 의하여 조직 치료 전극의 노출된 단부로부터 떨어져 있는 유체 접촉 표면을 구비한다. 상기 기구는, 사용할 때 조직 치료 전극 및 복귀 전극간에 전기적인 회로를 형성하는 전도성 유체 통로를 형성하도록, 조직 치료 전극의 노출된 단부의 영역에 전기적 전도성 유체를 공급하기 위한 공급(feed) 수단을 더 포함한다.
이러한 방식으로, 복귀 전극이 기구상에 또는 기구의 내부에 조직 치료 전극으로부터 멀리 이격되어 위치될 수 있도록 기구를 통하여 유체를 전달함에 의하여 전기 수술 기구의 단부 주위에 국부적인 전도성 유체 환경을 형성하는 것이 가능하다.
따라서, 이 기구의 전극 구조는 하나의 활성(조직 치료)전극 및 멀리 떨어진 복귀 전극을 구비한 단극성 전극의 구성과 유사하다. 상기 복귀전극은 단점없이 양극성 전기 수술의 안전성에 관한 모든 장점을 제공하기 위하여 기구 축상에 위치된다. 두 전극의 분리는 전도성 매질의 공급에 의하여 지지되고, 종래의 단극성 전기 수술 보다 낮은 전력 레벨에서, 종래의 양극성 전기 수술에 비하여 큰 전력이 공급되도록 한다. 상기 장치는 또한 레이저 수술과 유사한 조직의 접촉 증기부식법(vaporization)을 실행할 수 있다.
복귀 전극은, 사용중에 치료되는 조직에 접촉하지 않도록 그리고 전기적인 회로가 항상 전도성 유체에 의하여 형성되고, 단지 전극간의 아크에 의하여는 형성되지 않도록 조직 치료 전극으로부터 떨어져 있다. 실제로, 상기 장치는 전극 조립체의 인접 부분간의 아크가 방지되고, 이것에 의하여, 진공 포켓에 들어가는 조직이 전도성 유체를 경유하여 복귀 전극으로 유입하는 전류를 위한 바람직한 경로가 되도록, 조직 치료 전극이 진공 포켓에 둘러싸여 질 수 있는 것을 확실히 한다.
본 발명의 전기 수술 기구는 조직의 절개, 절제, 기화, 탈수, 및 응고와 복강경,자궁경부 확대경(질 검사경을 포함함), 및 여성의 생식관 및 자궁부속 질병에 대한 개방 외과 수술 과정에의 특별한 응용을 가진, 상기 기능들의 조합에 유용하다. 복강경 수술 과정은, 부융모막(subserosal), 육경(肉莖) 섬유(pedunculated fibroid)의 제거, 자궁외 자궁내막(ectopic endometrium)의 절개,난소 낭포 절개술(ovarian cystectomy), 난소 드릴링(drilling) 과정; 난소 절개술(oophorectomy), 난관개구술(salpingo-oophorectomy), 부분 자궁절개술(subtotal hysterectomy), 양성 또는 악성 질병을 위하여 수행될 수 있는 복강경 지원 질 절개술(LAVH : laparaoscopically assisted vaginal hysterectomy); 복강경 자궁 천골 신경 절제(LUNA : laparoscopic uterosacral nerve ablation); 자궁외 임신이나 후천적 장애에 의한 합병증의 교정으로서 나팔관 수술; 복부 흡착의 분리; 및 지혈을 포함할 수 있다.
본 발명의 전기 수술 기구는, 또한, 일반적으로 검사경 및 질확대경을 포함하는 장치를 사용하거나 직접 접근시키는, 경부, 질, 및 외음부의 치료를 포함하는 하부 여성 생식관에도 유용하다. 그러한 적용은, 질 절개술 및 질 접근을 사용하는 다른 골반 수술; LLETZ/LEEP 과정(전환 영역의 대 루프 절개:large loop excision of the transformation zone)또는 내경부의 전환 영역의 절개; 포낭 또는 패혈증 손상의 제거; 생식 또는 성병 혹의 절제; 양성 또는 악성 손상의 절개; 질 탈수(prolapse)를 포함하는 성형 및 외과적 복구; 병든 조직의 절제; 및 지혈을 포함한다.
본 발명의 전기 수술 기구는 조직의 절개, 절제, 기화, 탈수, 및 응고와 이비인후(ENT) 대한 개방 외과 수술 및 더 특정하여 구인두(oropharynx), 비인두 (nasopharynx), 및 두(sinuses)에 대해 수행되는 과정에의 특별한 응용을 가진, 상기 기능들의 조합에 유용하다. 이들 과정은 검사경 또는 개구기(gag)를 사용하거나 기능적 내시경 공동 수술(FESS : functional endoscopic sinus surgery) 과 같은 내시경 기술을 사용하여 입 이나 코를 통하여 수행된다. 기능적 내시경 공동 수술은, 두개골의 다양한 해부학적 공동(空洞)들로부터의 만성적이고, 염증이 생기고, 비대성인(hypertrophic) 점액 내층(mucus lining), 용종(polyp), 및 종양(neoplasm)의 제거; 병에 걸린 조직의 절개; 및 지혈을 포함한다. 비인두에 대한 과정은, 갑개골(turbinate) 및 비통로(nasal passage)로부터 만성적이고, 염증이 생기고, 비대성인 점액 내층, 용종, 및 종양의 제거; 비격막(nasal septum)의 부 점액(submucus) 부분적 절제; 병에 걸린 조직의 절개; 및 지혈을 포함할 수 있다. 구인두에 대한 과정은, 특히 편도선, 인두 편도(adenoid), 후두개(epi-glottis) 및 상두개(supra-glottis)의 영역, 및 타액선에 관련될 때, 만성적이고, 염증이 생기고, 비대성인 점액 내층, 용종, 및 종양의 제거; 일반적으로 레이져 보조 구개 성형술(uvulopalatoplasty)이라고 흔히 알려진 과정을 수행하는 선택적인 방법; 병에 걸린 조직의 절개; 및 지혈을 포함할 수 있다.
본 발명의 전기 수술 기구는 조직의 절개, 절제, 기화, 탈수, 및 응고와 일반적인 복벽경(lapaaroscopic), 흉곽경(thoracoscopic), 및 신경 외과 수술 과정에서의 이들 기능의 결합에 대하여 부가적인 응용이 가능하다는 것이 본 발명의 적용 범위로부터 명백하다. 특히, 양성 또는 악성의 병에 걸린 조직 및 종양성 질병의 제거에 유용하다.
본 발명의 전기 수술 기구를 사용하는 외과 수술은, 해부학적인 체강 또는 공간에 존재할 수 있는 자연적인 도관 또는 기구자체를 사용하거나 또다른 기술에 의하여 외과적으로 형성된 인공적인 도관(캐뉼러(cannula))을 통하여, 수술 부위로 전극 조립체를 도입하는 것을 포함한다. 공동이나 공간은 유체를 사용하여 수술중에 확장될 수 있고, 또는 해부학적 구조에 의하여 자연적으로 개방되어 유지될 수 있다. 수술부위는, 가스 충전 공동, 또는 신체 외부 또는 외과 수술 과정의 일부 중에 노출되는 조직 표면과 같은 곳의 전극 조립체의 말단 주위에 국부적으로 급수가 이루어지는 환경을 형성하기 위하여, 식염수와 같은 전도성 유체의 연속적인 흐름에 잠겨 있을 수 있다. 급수되는 유체는, RF 에너지의 적용에 의하여 형성되는 산물, 조직 파편, 또는 혈액을 제거하기 위하여 수술부위로부터 흡입될 수 있다. 수술과정은, 동시에 내시경을 통하여 또는 간접적인 시각화 수단을 사용하여 부위를 관찰하는 것을 포함할 수 있다.
바람직한 실시예에서, 기구는 조직 치료 전극의 노출된 단부의 영역으로부터 전기적 전도성 유체를 제거하는 제거수단을 더 포함할 수 있다. 제거수단은 전도성 유체가 식염수와 같은 액체일 경우에 더욱 중요한데, 이는 전기 수술 출력에 의하여 가열된 염수가 부차적인 조직 손상의 위험을 방지하기 위하여 제거될 필요가 있기 때문이다.
염수와 같은 전기적 전도성 유체를 조직 치료(활성) 전극의 영역에 지속적으로 공급하고, 이 영역에서 유체를 계속적으로 제거함에 의하여, 활성 전극에 국부적인 유체 필드를 형성하는 것이 가능하다. 더욱이, 이 영역에서 유체가 일정하게 보충됨에 의하여, 활성 전극의 온도가 소망하는 수준으로 유지될 수 있다.
바람직하게는, 제거수단은 기구 축 내에 형성된 유체 복귀 채널 및 유체 복귀 채널의 중앙부에 가까운 단부에서 흡입하는 수단으로 구성되고, 공급수단은 기구 축 내에 형성된 유체 공급 채널로 구성된다. 유체 공급 채널은 상기 유체 복귀 채널 주위에 위치될 수 있다.
바람직한 실시예에서, 복귀 전극은 절연재로 코팅된 관 부재이고, 상기 코팅된 복귀 전극은 기구 축을 구성한다. 바람직하게는, 관 부재의 내부 표면은 복귀전극을 구성한다. 바람직하게는 관 부재는 스테인레스 강으로 형성된다. 이 경우에, 조직 치료 전극은 상기 관 부재내에서 절연 스페이서에 의하여 중앙에 지지된다. 편리하게는, 절연 스페이서는 세라믹 물질인 실리콘 고무 또는 유리로 형성된다.
기구는 상기 스페이서에 인접하여 연장되는 튜브를 더 포함한다. 바람직하게는, 공급 채널은 복귀 전극과 튜브 간의 환형 공간에 의하여 구성되고, 복귀 채널은 튜브의 내부와 스페이서를 통하여 연장되는 개구(aperture) 수단에 의하여 구성된다.
선택적으로, 기구는, 상기에 언급된 튜브형 스테인레스 강 부재의 내부에 동심원적으로 위치된 제2 관형 스테인레스 강 부재에 의하여 구성된 제2 복귀 전극을 더 포함할 수 있다. 이 경우, 공급 채널은 두 개의 복귀전극간의 환형 공간에 의하여 구성되고, 복귀 채널은 제2 복귀전극 및 튜브간의 환형 공간에 의하여 구성된다.
본 발명은 또한 라디오 주파수 발생기 및 상기에 기술된 바와 같은 전기적 전도성 유체 매질의 존재하에 조직의 치료를 위한 전기 수술기구를 포함하는 전기 수술 장치를 제공한다.
바람직하게는, 라디오 주파수 발생기는, 전극에 공급되는 출력 전력을 변화시키는 제어수단을 포함하며, 상기 제어수단은 제1 및 제2 출력 범위에서 출력 전력을 공급하도록 한다. 이때, 상기 제1 출력 범위는 조직 건조를 위한 전기 수술 기구에 전력 공급을 하기 위한 것이고, 제2 출력 범위는 절단 이나 기화에 의한 조직 제거를 위한 전기 수술 기구에의 전력 공급을 위한 것이다. 바람직하게는, 제1 출력 범위는 약 150 볼트 내지 200 볼트이고, 제2 출력 범위는 약 250 내지 600 볼트이며, 이들 전압은 최대 전압이다.
본발명은 또한, 최소한 조직 건조 모드 및 조직 기화 모드를 구비한 전기 수술 장치를 작동하는 방법을 제공하는데, 상기 장치는 전기적 전도성 유체 매질의 존재하에 조직의 치료를 위한 전극 조립체에 결합되는 라디오 주파수 발생기를 구비한다. 상기 전극 조립체는 조직 치료 전극 및 절연 부재에 의하여 조직 치료 전극으로부터 전기적으로 절연된 복귀 전극을 포함하며, 이때, 상기 조직 치료 전극은 조립체의 최말단부에서 노출되어 있고, 복귀 전극은 절연부재에 의하여 조직 치료 전극의 노출된 말단부로부터 이격된 유체 접촉 표면을 구비한다.
상기 방법은, 전기적 전도성 유체를 상기 조직 치료 전극의 노출된 말단부의 영역에 공급하는 단계; 및
라디오 주파수 발생기의 출력 전력이 조직 건조 모드용 제1 출력 범위 내에 위치하도록, 그리고, 조직 기화 모드용 제2 출력 범위 내에 위치하도록 제어하는 단계를 포함한다. 여기에서, 제1 출력 범위는, 전극 조립체에 공급되는 전력이, 조직 치료 전극을 둘러싸는 기포를 형성하지 않으면서, 조직 치료 전극에 인접하는 전도성 유체를 실질적으로 조직 건조를 위한 비등점에 유지하도록 하는 범위이고, 제2 출력 범위는, 조직의 기화를 위해 전극 조립체에 공급되는 전력이, 조직 치료 전극을 둘러싸는 기포를 유지하도록 하는 범위이다.
바람직하게는, 상기 방법은 조직 치료 전극의 노출된 단부의 영역으로부터 전기적 전도성 유체를 제거하는 단계를 더 포함한다.
본발명은 또한 다음 단계를 포함하는 전기 수술 조직 건조 방법을 제공한다.
상기 방법은, 노출된 최단부를 구비한 조직 치료 전극 및 복귀 전극을 포함하는 전극 조립체에 결합되는 라디오 주파수 발생기를 포함하는 전기 수술 장치를 제공하는 단계;
치료되는 조직의 근처에, 조직 치료 전극을 사용하여 선택된 수술 부위내로 전극 조립체를 도입하는 단계;
조직 치료 전극의 노출된 단부의 영역에 전기적 전도성 유체를 공급하는 단계;
상기 발생기를 작동시키는 단계; 및
조직처리전극 주위의 증기 포켓 생성없이 실질적으로 끓는 점에서 조직처리전극에 인접한 전도 유체를 유지하기 위해 발생기에 의해 전극 조립체에 공급된 라디오 진동수 전원을 조절하는 단계를 포함하여 이루어진다.
이러한 경우에 복귀전극은 조직처리전극에 대해 인접하게 놓여질 수도 있고, 그 전극 조립체는 그 조직처리전극이 처리되는 조직과 접촉할 수 있을 만큼 선택 수술 지점에 유입되고, 그 복귀전극은 전기적유도 유체에 분산되며 그 전극 조립체는 조직처리전극에 인접한 요구영역에서 조직의 가열 및 건조를 유발하도록 조작된다.
바람직하게는, 그 전극조립체는 조직 처리전극을 조직의 표면을 가로지르도록 움직임으로써 병렬 페인팅 기술로 처리되도록 조작된다.
본 발명은 또한 다음의 단계를 포함하여 이루어지는 전기외과적 방법을 제공한다.
상기 방법은 조직 처리전극과 복귀 전극을 포함하여 이루어지는 전극 조립체에 결합되는 라디오 주파수 발생기와, 노출디지탈말단부를 가지는 조직처리전극을 포함하여 이루어지는 전기외과적 기구를 제공하는 단계와;
처리되는 조직에 인접한 조직 접촉전극으로 그 전극 조립체를 선택술에 도입하는 단계와;
조직 처리전극유체를 조직 처리전극의 노출말단부에 공급하는 단계와;
그 발생기를 작동시키는 단계와;
조직처리전극 주위의 증기포켓을 유지하도록 조직처리전극주위의 전기-전도 유체를 기화하기 위해 충분한 라디오 진동수 전원을 전극 조립체에 공급하는 단계를 포함하여 이루어진다.
바람직하게는, 복귀전극은 조직처리전극에 있어 근접하게 거리를 두고, 그 전극 조립체는 선택수술지점으로 도입되어 그 조직처리전극은 처리전극과 최소거리로 인접하도록 위치되어 증기 포켓이 그 조직과 접촉되고, 복귀전극은 전기적 전도 유체과 접촉하고, 전극 구조는 조직의 최소한의 기화가 일어나도록 조작된다.
본 발명은 다음 도면을 참고로하여 실시예에 의해 보다 상세히 설명될 것이다.
아래에서 설명되는 각 전기외과적 기구는 정상 식염수 또는 아르곤과 같은 전도성 매질과 함께 사용되게 된다. 각 기구는 이중 전극 구조를 가지고, 처리되는 조직과 전극 중 도체로서 작용하는 전도성 매질을 가지고, 이하 복귀전극이라고 한다.
다른 전극은 조직에 직접 또는 즉시 인접하게 공급되고, 이하 조직처리(활성)전극이라 한다. 많은 경우에, 유체매질의 사용은 대부분의 환경에서 과다한 전극 온도를 막으므로 바람직하고, 조직 응고를 크게 막는다.
도면에 있어서, 도 1은 연결 코드(4)를 통하여 핸드 피스(3) 형태의 기구를 위한 라디오(RF) 진동수 출력을 제공하는 출력 소켓(2)을 가지는 발생기(1)를 포함하는 전기외과적 기구를 보인 것이다. 발생기(1)의 활성화는 연결 코드(4) 내의 조절연결체를 통해 핸드 피스(3)로부터, 또는 풋 스위치 연결코드(6)에 의해 발생기(1)의 후방으로 분리되게 연결된 풋스위치(5)에 의해 형성될 수 있다. 도시된 실시예에서, 풋스위치(5)는 발생기(1)의 건조 모드 및 기화 모드 각각의 선택을 위한 두 개의 풋스위치(5a,5b)를 가진다. 발생기 전방패널은 표시부(8)에 나타나는 건조 및 기화 전원 레벨 각각을 설정하기 위한 푸쉬버튼(7a,7b)을 가진다.푸쉬버튼(9a)은 건조 및 기화 모드간의 선택을 위한 대안수단으로서 제공된다.
핸드 피스(3)은 아래에 기술되는 바와 같이 분리가능한 전기외과적(E)를 장착한다.
도 2는 전기외과적 기구(E1)의 첫 번째 형태의 말단부를 보인 것이다. 그 기구(E)는 그 말단부에 전극 조립체로 형성되고, 그 전극 조립체는 중앙 조직처리(활성) 전극(11)과 관형 복귀전극(12)을 포함하여 이루어진다. 활성 전극(11)은 플라티늄/이리듐 또는 플라티늄/텅스텐과 같은 혼합 귀금속으로 만들어지고, 그 복귀전극은 스테인레스 스틸 튜브이다. 복귀 전극(12)은 폴리이미드 절연 외장재(13)에 의해 완전히 덮힌다. 복귀 전극(12)은 전기외과적 기구(E1)의 전체 길이를 연장하고, 그 기구의 축을 구성한다.
전극(11,12)은 라디오 진동수(RF) 발생기(1)로부터의 전류가 제공되고,(도 2 에 미도시),복귀 전극(12)은 발생기에 활성 전극(11)은 구리전도체(14)를 통해 연결된다. 발생기(1)는 진행중인 영국 특허 출원 제9604770.9호의 명세서에서 설명될 것이다. 활성 전극(11)은 세라믹 절연체/역전류기(15)에 의해 복귀 전극(12)내 중심에 지지된다. 절연체/역전류기(15)는 일반적으로 활성 전극(11) 및 전도체(14)사이의 합류점 주위의 실린더부(15a)를 가지고, 절연체/역전류기(15)를 지지하는 복귀 전극(12)의 내주면과 접촉하는, 4개의 방사 연장 설치된 날개부(15b)를 가지며, 이로서 활성 전극(11)은 복귀전극내 중심에 있는다.
튜브(16)는 PTFE와 같은 절연물질로 만들어지고, 절연체/역전류기(15) 원통부(15a)의 말단 주위 마찰접합부이고, 기구의 전체 길이를 따라 충분히 연장된다.튜브(16)는 복귀 전극(12)와 함께 동축 식염수 공급 채널(17)을 한정하고, 튜브(16)의 내부는 식염수 복귀 채널(18)을 한정한다. 사용상, 식염수는 중력하에서 채널(17)로 공급되고 (펌핑은 요하지 않음), 식염수는 흡입에 의해 절연체/역전류기(15)의 실린더부(15a)에서 채널(18) 및 틈새(미도시)를 통하여 제거된다. 바람직하게는, 흡입은 고속 임펠러를 사용하기보다 이동 날개펌프 또는 다이아프램 펌프같은 저소음 펌프(미도시)에 의해 수행된다. 펌프로의 튜빙은 간헐적으로 소량의 식염수를 포함할 것이므로, 많은 진공(적어도 500mBar) 이 필요하다. 그러나, 제거되는 가스 및 액체의 양은 비교적 작고, 이것은 큰 부피의 연동펌프도 역시 사용될 수 있을 것이나, 이동펌프 또는 다잉프램 펌프의 사용을 허용한다.
펌프 소독의 필요성을 줄이기 위해 펌프는 10㎛의 PTFE를 결합시키는 일회용 액체 트랩을 통하여 조작한다. 이 필터는 배출 액체 및 가스 입자가 펌프에 의해 끌어 올려지거나, 주변을 오염시키는 것을 방지한다.
상기한 기구(E1)는 노출 공기 또는 가스가 채워진 환경에 있어, 주 유체에서의 사용을 위해 또는 기구의 팁 주변의 전도성 유체환경 생성에 의해 조직으로 삽입하여 사용하기 위한 것이다, 그리고, 이것은 기구의 말단에서 국부 식염수 영역을 생성하는 것이 가능하다. 이 기구(E1)는 그러므로, 복강경 검사 적용에 사용된다. 사용상, 식염수는 채널(17)을 통해 활성 전극(11)으로 공급되고, 식염수는 전도 매질이 처리조직 및 복귀 전극(12) 사이에서 전도경로로서 작용할 수 있도록 한다. 발생기(1)의 출력을 변화시킴으로써, 그 기구는 기화에 의해 조직 제거 또는 절단 또는 건조에 사용될 수 있다. 각 경우에, 식염수는 활성 전극(11)과 접할 수 있으므로, 이것은 발생기(1)의 전력 출력 및 식염수의 유속에 의존하는 평형온도에 도달한다. 평형시에는, 신선한 식염수는 채널(17)을 통해 활성 전극(11)으로 공급되므로, 축의 외부온도는 주변 식염수의 것과 같은 온도에서 유지된다. 절연 외장재(13)는 복귀 전극(12)의 외부표면을 완전히 덮으므로, 복귀저극과 조직사이의 갑작스러운 접촉이 방지된다.
저속 식염수를 사용하는 또 다른 장점은, 식염수 온도가 끓는 점에 도달할 수 있다는 것이다. 그러나, 식염수는 연속적으로 흐르므로, 복귀 전극(12)로부터 활성 전극(11)으로의 식염수내의 온도성분이 상승한다. 이러한 온도 성분의 상승은 중요한데, 이는 활성 전극(11)에 인접한 보다 고온의 식염수는 기화에 도달하기 요구되는 한계전력을 감소시키기 때문이다. 유속 요구량이 입력 전력을 기초로하여 계산될 수 있음에도 불구하고, 최대 전력밀도를 유지하는 발생기(1)의 유동성은 유속이 정밀하지 않다는 것을 의미한다. 예를 들어, 발생기가 100와트로 설정되면, 최대 유속은 이론적으로 다음과 같이 계산된다.
유속 = 전력/비열용량
= 100/4.2 X 75 cc/s
= 0.32 cc/s
= 19cc/min
이것은 25℃의 초기 식염수 온도, 4200J/kg/℃의 비열용량을 가정한 것이다.
비록 기화동안 식염수는 증기 상태로 됨에도 불구하고, 증기는 단지 활성 전극(11) 주변에서만 안정하다. 그러므로, 기화의 잠열에 의해 흡수되는 에너지는 무시될 수 있고, 이것은 이 에너지가 막 도달한 식염수에 의해 재생되기 때문이다.
또다는 중요한 요소는 식염수의 매우 짧은 순회경로에 의해 전류는 다수의 다른 경로를 따라 흐르는 것으로 간주될 수 있는데, 그러므로, 같은 전력 밀도를 가지지 않는다. 결과적으로, 기화는 식염수 환경내에서 불균둥 전력밀도에 의해 계산된 최대치 보다 높은 유속에서 발생한다. 그러나, 활성 전극(11)의 길이를 따라 발생하는 기화량은 유속에 의존할 것이다.
식염수는 활성 전극(11)에 의해 가열됨에 따라, 이것은 열적 괴사를 유발할 수 있어 잠재적으로 조직을 손상시킨다. 그러므로 모든 가열된 식염수는 적용 지점에 인접한 조직과 접촉하기 전에 환자로부터 배출되고 재생된다. 이것은 활성 전극(11)으로부터 배출저유부(미도시)로 흡입하는 이유이다. 그러나, 흡입이 과다하게 일어나도록 함으로써, 식염수 복귀 채널(18)을 통하지 않고, 활성 전극(11) 영역으로부터 식염수가 누수될 수 있다. 외부축위에 역으로 누수되는 어느 식염수도 흐름경로로부터 멀리 떨어지게 되어 가열되지 않는다. 그러므로 중요한 것은 가장 뜨거운 식염수가 제거되도록 하는 것이다. 열적 성분이 활성 전극(11)에 대해 최대로 인접할 때, 이것은 식염수에 있어 가장 적당한 배출점이다. 이것은 식염수가 절연체/역전류기(15)의 실린더부(15a)를 통하여 배출되도록 하는 이유이다.
식염수 배출점을 정하는 또다른 중요한 고려사향은 배출경로의 장애물의 잠재성이다. 이것은 쉽게 배출구를 막을 수 있는 조직 미립자를 자유롭게 하는 방식으로 조직을 절단 또는 기화할 때 발생한다. 이러한 배출점은 그러므로 활성 전극(11)의 최고에너지 밀도 점에서 선택된다. 이러한 측정은 배출점에 도달하는 어느 조직이 용액으로 순간적으로 기화되는 것을 보장하여, 장애물에 대한 포텐셜을 방지한다.
기화에 의한 조직 제거시 고도의 흡입을 보장하는 중요한 또다른 장점은 식염수에 의해 흡수되지 않는 어느 스모크 역시 배출된다는 것이다. 이것은 스모크가 생존가능한 생물학적 입자를 통할 수 있고, 이로서 감염가능성이 있게 된다.
상기한 바와 같이, 기화를 위한 한계전력은 잘 한정되지 않는다. 만일 기구(E1)가 정적 전도 매질에서 작동되고 있으면, 전극 임피던스가 활성 전극(11)주변에서 형성되는 증기포켓의 결과로서 갑자기 일어나는 임피던스 변환점에 의해 잘한정될 것이다. 이러한 한계점은 보통 식염수의 분산 메카니즘에 의존한다. 정적 환경에서, 분산 메카니즘은 주로 식염수내의 대류 흐름에 의한다. 이러한 환경에서, 기화에 대한 한계전력은 식염수로부터의 분산이 과다한 전극 활성영역으로의 입력 전력으로 정의된다. 그러나, 상기한 실시예에서, 활성 전극(11)주위의 식염수는 연속적으로 재생된다. 만일 그렇지 않으면, 유일한 분산 메카니즘은 기화의 잠열에 의하고, 식염수는 빨리 기화될 것이다. 플로우를 제공함으로써, 한계전력 레벨은 증가된다. 그러나, 한계전력 레벨은 활성 전극(11)의 주변에서, 식염수 재생 속도에 의존한다. 경계 층에서 재생 속도는 활성 전극(11)의 표면 끝을 바꿈으로써 조정될 수 있다. 예를 들면, 만일 활성 전극(11)이 부드러운 표면을 가지면, 식염수는 급속한 플로우 속도가 정해짐에 따라 급속히 재생될 것이다. 그러나, 활성 전극(11)이 불균일한 끝을 가지면, 불균일한 표면내의 포켓의 재생 속도는 감소된다. 그러므로, 불균일한 표면은 식염수를 잡고 (또는 적어도 재생을 연장시키고), 대체되기 전에 더 많은 전력을 흡수한다. 달리 말하면, 한계 전력은 불균일한 활성전극 표면에 의해 감소된다. 이것은 매우 바람직한 성질인데, 그것은 전극 전력필요량은 조직의 역형성없이 실질적으로 떨어진다. 한계 전력은 활성전극이 모세관 작용을 제공하기 위해 구성되기 때문에 더욱 감소된다. 그러므로 기화 상태에서조차, 활성 전극(11)은 간헐적으로 젖는다. 모세관 작용에 의해 이러한 적심이 전체활성 전극(11)을 적시도록 학인함으로써, 간헐적 적심을 최소화하는 증기의 연속적인 공급원이 되고 그래서 더욱 전력 요구량을 감소한다.
조직을 기화하기 위해, 식염수가 채널(17)로부터 활성 전극(11)에뿐 아니라, 조직에 접촉하는 것이 필요하다. 그 식염수는 그러므로, 활성 전극(11)을 덮는 일정한 방울을 형성해야 한다. 그러므로, 활성 전극(11)의 팁은 식염수 및 활성전극이 각도에 상관없이 조직과 동시에 접촉하도록 고안된다. 만일 채널(17)로부터 활성 전극(11)으로의 식염수의 흐름이 완전히 환형이면, 식염수는 한쪽에서 다른쪽으로 흐를 수 있으며, 이러한 경우 활성전극은 부분적으로 폐쇄될 수 있다. 이를 방지하는 것은 환형 채널(17)은 날개부(15b)에 의해 조각화되어 최상부에서의 식염수 흐름을 보장하도록 하는 것이다. 이것은 또한 모세관 작용을 증가함으로써 유입 식염수의 응집을 개선한다.
활성 전극(11)의 팁이 조직과 접촉하게 될 때, 조직과 접하는 영역은 식염수를 통하여 전력을 분산시키는 능력을 잃는다. 복귀 경로가 식염수의 흐름으로 구성되는 동안, 조직은 전력 분산을 위해 메카니즘을 가지지 않고, 그러므로 기화되는 점까지 빨리 가열된다.
조직을 기화시키는 기구의 효율성은 지지되는 방울과 활성 전극(11)의 길이사이의 비율에 의존한다. 더 긴 활성 전극(11)가 가장 요구되는데, 이는 일정한 방울을 유지하는 능력이 감소되기 때문이다. 그러나, 일단 활성 전극(11)이 조직 내에서 포켓을 기화시키면, 복귀 전극(12)은 조직표면에 더욱 가까워져서, 기화는 더욱 쉬워지는데, 이는 식염수를 가로지르는 더욱 작은 전압 강하가 있고, 단지 전기 회로의 더 작은 부분을 형성하기 때문이다.
발생기(1)의 출력을 변화시킴으로써, 기구(E1)는 건조(응고)에 또한 사용될 수 있다. 이러한 경우에, 발생기는 활성 전극(11)의 표면에서 작은 기포가 형성하도록 조절되나, 불충분한 기포가 생성되어 전극의 활성 팁 주변에 기포를 제공하도록 생성되는데, 이 기포는 기화에 의한 조직제거에 필수적이다.
발생기(1)는 조직 건조 및 기화에 의한 조직 제거를 위한 가각의 출력 범위를 가진다. 이전 영역은 150 볼트로부터 200 볼트이고, 이후 영역은 250 볼트에서 피크 전압이 600 볼트이다. 기화 모드에서 발생기(1)는 활성 전극(11)의 과열을 방지하는 방식으로 조절된다. 이것은 일단 증기 포켓이 구성되면, 발생기(1)의 출력 전압내의 감소를 요한다. 발생기(1)과 그 조절수단은 영국 특허 출원 제9604770.9호에서 더욱 상세히 기술될 것이다.
전극으로부터의 응고는 종래의 양극성 전극보다 대체로 우월하다. 그 이유는 두가지이다. 우선, 응고 메카니즘은 단지 조직 내의 전기흐름에 의한 것이 아니고, 가열 식염수에 의한 것이기도 하기 때문이다. 두 번째로, 정상 환경에서, 조직에 전력을 공급하는 가장 약한 연결부는 전극/조직 접촉면인데, 이는 이것이 가장 높은 전력 밀도점이기 때문이고, 이로서 전력의 한계를 지우기 때문이다. 만일 너무 높은 전력 레벨이 시도되면, 접촉면에서의 조직은 잔류 회로를 형성하는 보다 큰 조직의 크로스 섹션보다 빠르게 급속히 건조된다. 만일 더 낮은 전력이 선택되면, 접촉면은 기화외의 다른 마케니즘에 의한 온도 상승을 분산시킨다. 결과적으로, 접촉면은 오랫동안 그대로 남고, 이로서 더욱 큰 효과가 얻어질 수 있다. 이 실시예에서, 전기적 접촉면은 식염수에 의해 더욱 강해지고, 목적 조직을 완전히 건조하는 것이 가능하지 않다. 그러므로, 전력은 보다 긴 기간동안 높은 속도에서 전달될 수 있고, 순수 시간 및 전력이 관계되는 효과가 된다.
도 3은 전기외과 기구의 두 번째 형태의 말단을 보인 것이다. 이 기구는 도 2 에 보인 것의 응용이고, 참조 번호는 유사 부분에 사용될 것이고, 단지 수정이 상세히 기술될 것이다. 주된 변경은 도 2 의 기구는 두 개의 동축, 관형 복귀 전극(12,12')을 포함하고, 복귀 전극(12')은 복귀전극(12)보다 조금 짧고, 그 사이에 위치한다는 것이다. 두 복귀전극(12,12') 사이의 환형 틈은 식염수 공급 채널(17)을 구성하고, 식염수 복귀 채널(18)은 복귀채널(12') 과 절연체/역전류기(15) 및 튜브(16)의 실린더부(15a)에 의해 구성되는 중심부 사이의 환형 틈에 의해 구성된다. 튜브(16)는 또한 절연체/역전류기(15)의 실린더부(15a) 및 활성전극(14)의 인접 말단 주위의 마찰 접합부를 형성하도록 조절된다.
도 3의 기구가 갖는 장점은, 조직표면(예컨데, 종양내 조직)내에 증기 포켓을 생성시키기 위해 사용될 때 식염수가 식염수 회수관(18)로 되돌아가는 경로가 폐쇄될 확률이 적다는 것이다. 따라서 도 2에 의한 기구에 의하여 증기 주머니를 생성시킬 때, 활성전극(11)과 복귀전극(12) 사이에 전도 경로를 형성하는 식염수의 일부는 조직에 의하여 회수관(18)으로의 진입이 방해되어 누수될 수 있다. 이 식염수는 일부 주변 조직을 사멸(blanching)시킬 수 있을 정도로 높은 온도로 될 수 있다. 조직의 사멸은 기구의 크기에 의존하기 때문에 주변조직의 사멸양이 허용가능한 수준에서 유지되도록, 도 2에 의한 기구는 작은 규격이어야 한다.
반면에 도 3에 의한 기구에 의하면, 활성전극(11)에서 회수관(18)으로의 식염수의 회수경로는 조직에 의해서 방해받지 않는다. 더욱이 활성전극(11)과 복귀전극(12) 사이의 전도경로가 방해되는 경우, 활성전극(11)로부터 방해받는 염수의 일부는 감소된 전력분산(power distribution) 값을 갖는다. 이 전력분산의 감소는 출입하는 염수가 회수관(18)에 통하여 있기 때문이며, 따라서 대부분의 전력분산이 방해조직내에서 발생할 정도까지 임피던스가 감소한다. 예비관(예비 복귀전극 12')과 팁의 외형비(aspect ratio) 때문에 도 3의 기구는 도 2의 기구에 비교하여 소형화하기 어렵다(즉, 활성전극(11)은 수염수 배출구가 더 뒤에 위치해야 하므로 지름 이상 돌출할 수 없다).
이 배출구는 제2복귀전극(12')을 통과하므로 더 뒤에 위치해야 한다. 그렇지 아니하면 활동전극(11) 길이 전체에 걸쳐 과도한 전력분산을 초래한다.
도 3에 의한 실시예로 부터의 배출식염수에는 미세 조직입자들이 있을 수 있다. 배출경로가 반드시 증가화되는 영역을 통과하는 것은 아니므로, 배출경로의 폐쇄가능성 때문에 이 기구는 어느 정도의 크기 이하로 축소되기 어렵다.
상기에서 서술된 각 기구의 증기부식화 효율은 활성전극(11)이 식염수 유동에 대한 트랩 또는 최소한 인터럽트로 설계되었을 때 최상이 된다.
왜냐하면 식염수가 활성전극(11) 기부에 인접하여 오래 머무를수록 활성전극(11)은 전력을 많이 소모하게 되고 따라서 증기를 형성하는 성향이 증대되기 때문이다. 예를들면 활성전극의 꼬인 선형태가 코일형태의 활성전극으로 대치되는 것이 가능할 것이다. 또한 세라믹 미분자를 분무하여 불균일하게 증착시키는 방식의 차단에 의하여 활성전극/식염수 경계면을 부분적으로 방해하면 증기부식화의 개선이 가능하다.
상기에서 서술된 기구들은 다음과 같은 장점을 구비한다:
(1) 하나의 전극(활성전극(11))을 직접 조직에 접촉시킴으로써 단극과 유사한 작용을 제공한다.
(2) 레이져 기구와 유사한 방식으로 조직을 즉시 디벌킹화(증기부식화)한다.
(3) RF 전류가 처방되는 부위에 한정되므로 2차원적 또는 3차원적인 열피해를 방지하고 인접조직의 화상을 방지한다.
(4) 주변 식염수의 냉각·응축·용해 (해소) 작용에 의하여 절단 또는 증가화 과정에서의 연기발생이 최소화되며, 발생된 연기는 활성전극(11)에 인접한 흡입기에 의하여 즉기 제거된다.
(5) 전극 조립체내의 전류경로가 양방향이기 때문에 어느 전극의 입구점에서도 용량성 결합이 최소로 된다.
(6) 식염수는 오로지 전류의 세기와 적용시간에 의존하는 응결의 깊이가 조정되도록 전류를 유지하는 훌륭한 활성전극/조직 경계면을 제공한다.
(7) 기구의 전류경로가 식염수에 의하여 연결되기 때문에, 조직의 치유에 해롭고, 유착형성의 위험성이 커지는 것으로 알려진 심각한 탄화를 초래할 수 있는 고임피던스 상황을 방지한다.
(8) 우수한 저임피던스 활성전극/조직 경계면에 의하여 조속한 효과를 위한 보다 높은 전력의 사용이 가능하다.
(9) 전형적인 양극성 전기 외과적수술의 경우에 비교하여 훨씬 높은 전력 수준이 지지된다. 실제로 전형적인 양극 전기 외과적수술은 40∼50와트 이하에서만 유효하며, 그 이상의 전력수준에서는 과열과 탄화가 유발된다. 도 2와 3의 전극 구성에는 200와트가 초과되는 전력의 공급이 가능하다.
상기에 기술된 기구에 대하여 다양한 변형이 가능할 것이다. 따라서 활성전극(11)은 침형전극 또는 백금/이리듐과 같은 소재로 된 중공이며 천공된, 부분적으로 구형인 전극등과 같이 다른 적절한 형상이 될 수 있고, 절연체/공간자(15)는 실리콘고무 또는 유리로 제조될 수 있다. 또한 전도매체로서 샐린은 아르곤 가스와 같은 전도성 가스로 대치될 수 있다. 이 경우 관(17)을 통해 활성전극(11)의 부위로 주입되어야 하는데 고온의 아르곤은 주변조직에 해가 없기 때문에 회수관(18)을 통해 회수될 필요는 없을 것이다. 또한 이 경우 변형된 형태의 RF 발생기가 필요하게 될 것이다. 전체 전극 조립체는 탄성 조립체 또는 견고한 조립체로 제작될 수 있으며, 또한 활성 팁 또는 조직내로의 투입을 조정하는 수단에 결합될 수도 있다.

Claims (27)

  1. 전기 전도성 유체매체의 존재하에 조직 치료를 위한 전기 외과적 수술기구에 있어서,
    기구축과;
    조직치료 전극과, 절연수단에 의하여 상기 조직치료 전극으로부터 전기적으로 절연된 복귀전극을 포함하는 상기 기구축의 한쪽 말단에 위치하는 전극 조립체와;
    사용할 때 상기 조직치료 전극과 복귀전극간의 전기회로를 완성시키는 전기전도성 유체경로를 확정할 수 있도록 전기 전도성 유체를 상기 조직치료 전극의 노출된 말단 부위로 주입하는 주입수단;을 포함하며,
    상기 조직치료전극은 상기 기구의 최말단에 노출되어 있고, 유체 접촉면을 갖는 상기 복귀전극은 절연체에 의하여 상기 조직치료 전극의 노출 말단과 간격을 두고 배치되는 것을 특징으로 하는 전기외과적 수술기구.
  2. 제 1 항에 있어서, 상기 조직치료 전극의 노출말단부로부터 전기 전도성 유체를 제거하기 위한 제거수단이 추가로 포함되는 것을 특징으로 하는 전기외과적 수술기구.
  3. 제 2 항에 있어서, 상기 제거수단은 상기 기구축 내부에 형성된 유체회수관과 상기 유체회수관의 기부말단에 흡입력을 발생시키는 (흡입)수단으로 구성되는 것을 특징으로 하는 전기외과적 수술기구.
  4. 제 1 항 내지 제 3 항중 어느 한항에 있어서, 상기 주입수단은 상기 기구축 내부에 형성된 유체주입관으로 구성되는 것을 특징으로 하는 전기외과적 수술기구.
  5. 제 3 항을 인용하는 제 4 항에 있어서, 상기 주입수단은 상기 유체회수관 주위에 위치하는 것을 특징으로 하는 전기외과적 수술기구.
  6. 제 1 항 내지 제 5 항중 어느 한항에 있어서, 상기 복귀전극은 절연체로 피막된 관체(tubular member)로서, 피막된 복귀전극 자체가 상기 기구축을 구성하는 것을 특징으로 하는 전기외과적 수술기구.
  7. 제 6 항에 있어서, 상기 관체의 내부표면이 복귀전극을 구성하는 것을 특징으로 하는 전기외과적 수술기구.
  8. 제 6 항 또는 제 7 항에 있어서, 상기 관체는 스테인레스 재질인 것을 특징으로 하는 전기외과적 수술기구.
  9. 제 6 항 내지 제 8 항중 어느 한항에 있어서, 상기 조직치료 전극은 상기 관체의 중앙에서 절연공간에 의하여 지지되는 것을 특징으로 하는 전기외과적 수술기구.
  10. 제 9 항에 있어서, 상기 절연공간은 세라믹소재, 실리콘고무 또는 유리재질인 것을 특징으로 하는 전기외과적 수술기구.
  11. 제 9 항 또는 제 10 항에 있어서, 상기 (절연) 공간에 가까이 확장된 관(菅)을 추가로 포함하는 것을 특징으로 하는 전기외과적 수술기구.
  12. 제 5 항을 인용하는 제 11 항에 있어서, 상기 유체주입관은 상기 복귀전극과 상기 관 사이의 환상공간으로 구성되며, 상기 회수관은 상기 관의 내부와 상기 (절연) 공간을 통하여 확장된 틈새부(aperture means)로 구성되는 것을 특징으로 하는 전기외과적 수술기구.
  13. 제 1 항 내지 제 11 항중 어느 한항에 있어서, 상기 관체의 내부에 동축적으로 위치하는 제2관체로 구성되는 제2복귀전극을 추가로 포함하는 것을 특징으로 하는 전기외과적 수술기구.
  14. 제 5 항 및 제 11 항을 인용하는 제 13 항에 있어서, 상기 주입관은 상기 두 복귀전극 사이의 환상공간으로 구성되며, 상기 회수관은 상기 제2복귀전극과 상기 관 사이의 환상공간으로 구성되는 것을 특징으로 하는 전기외과적 수술기구.
  15. 라디오파 발생기와 전기전도성 유체의 존재하에서 조직치료를 위한 전기외과적 수술기구를 포함하는 전기외과적 수술장치에 있어서, 상기 전기외과적 수술기구는 제1항 내지 제14항에 의한 전기외과적 수술기구인 것을 특징으로 하는 전기외과적 수술장치.
  16. 제 15 항에 있어서, 상기 라디오파 발생기는 다양한 출력을 상기 전극에 전달하기 위한 조절수단을 포함하는 것을 특징으로 하는 전기외과적 수술장치.
  17. 제 16 항에 있어서, 상기 조절수단은 상기 전기외과적 수술기구가 조직을 건조시킬 수 있도록 하는 제1출력 범위와, 상기 전기외과적 수술기구가 조직을 절단 또는 증기부식화시켜 제거할 수 있도록 하는 제2출력 범위의 출력을 제공하게 되는 것을 특징으로 하는 전기외과적 수술장치.
  18. 제 17 항에 있어서, 상기 제1출력범위는 최고 150∼200볼트이고 상기 제2출력 범위는 최고 250∼600볼트인 것을 특징으로 하는 전기외과적 수술장치.
  19. 최소한 조직건조모드와 조직증기부식화 모드를 가지며 전기전도성 유체의 존재하에 조직치료를 위한 전극 조립체에 결합된 라디오파 발생기를 포함하는 (전기외과적 수술장치) 것으로서, 상기 전극조립체는 조직치료전극과 절연수단에 의하여 상기 조직치료 전극으로부터 전기적으로 절연된 복귀전극을 포함하며,
    상기 조직치료전극은 상기 조립체의 최말단에 노출되어 있고,
    유체접촉면을 갖는 상기 복귀전극은 절연체에 의하여 상기 조직치료전극의 노출된 말단과 간격을 두고 배치되는 전기외과적 수술장치의 다음과 같은 단계를 포함하는 것을 특징으로 하는 작동방법.
    (1) 전기전도성 유체를 상기 조직치료 전극의 노출된 말단부위로 주입하는 단계와;
    (2) 조직건조 모드인 경우 제1출력 범위내에, 조직 증기부식화 모드인 경우 제2출력 범위에 있도록 라디오파 발생기를 조직하는 단계.
    이때 제1출력범위는 조직치료전극 주위에 증기 포켓을 생성하지 아니하고 조직을 건조시키기 위해 상기 조직치료 전극에 인접한 상기 전기전도성 유체가 실질직으로 기화온도로 유지되도록 상기 전극 조립체에 전력을 공급하게 되며, 제2출력범위는 조직의 증기부식화를 위하여 상기 조직치료 전극 주위에 증기 포켓이 유지되도록 상기 전극조립체에 출력을 공급하게 된다.
  20. 제 19 항에 있어서, 상기 조직치료 전극의 노출된 말단부위에서 전기전도성 유체를 제거하는 단계를 추가로 포함하는 것을 특징으로 하는 전기외과적 수술장치의 작동방법.
  21. 제 19 항 또는 제 20 항에 있어서,
    상기 제1출력범위는 최고 150∼200볼트이고, 상기 제2출력범위는 최고 250∼600볼트인 것을 특징으로 하는 전기외과적 수술장치의 작동방법.
  22. 다음의 단계를 포함하는 것을 특징으로 하는 전기외과적 조직 건조방법.
    (1) 말단이 노출된 조직치료 전극과 복귀전극을 포함하는 전극 조립체에 결합된 라디오파 발생기를 포함하는 전기외과적 수술장치를 준비하는 단계;
    (2) 조직치료 전극이 치료받게 될 조직에 인접되도록 상기 전극조립체를 수술부위내로 도입하는 단계;
    (3) 전기전도성 유체를 상기 조직치료 전극의 노출된 말단부위로 주입하는 단계;
    (4) 상기 발생기를 작동시키는 단계와;
    (5) 치료전극 주위에 증기 포켓을 생성하지 아니하고 상기 치료전극에 인접한 전기전도성 유체가 실질적으로 기화온도로 유지되도록, 상기 발생기에서 전극조립체로 공급되는 라디오파 전력을 조절하는 단계.
  23. 제 22 항에 있어서, 상기 복귀전극은 상기 조직치료 전극에 대하여 기부쪽으로 간격을 두고 배치되며, 상기 조직치료 전극이 치료받게 될 조직과 접촉되도록 상기 전극조립체가 수술부위내로 도입되고, 상기 복귀전극은 전기전도성 유체에 잠기며, 상기 전극조립체는 상기 조직치료 전극에 인접한 부위의 조직을 가열·건조하도록 조작되는 것을 특징으로 하는 전기외과적 조직건조방법.
  24. 제 23 항에 있어서, 상기 조직치료 전극이 치료받게 되는 조직의 표면을 가로질러 사이드-투-사이드 페인팅 기법으로 이동함으로서 상기 전극조립체가 조작되는 것을 특징으로 하는 전기외과적 조직건조방법.
  25. 다음과 같은 단계를 포함하는 것을 특징으로 하는 전기외과적 조직 건조방법.
    (1) 말단이 노출된 조직치료 전극과 복귀전극을 포함하는 전극 조립체에 결합된 라디오파 발생기를 포함하는 전기외과적 수술장치를 준비하는 단계;
    (2) 조직치료 전극이 치료받게 될 조직에 인접되도록 상기 전극조립체를 수술부위내로 도입하는 단계;
    (3) 전기전도성 유체를 상기 조직치료 전극의 노출된 말단부위로 주입하는 단계;
    (4) 상기 발생기를 작동시키는 단계와;
    (5) 조직치료 전극 주변의 증기 포켓을 유지하기 위하여 조직치료전극 주변의 전기전도성 유체를 증기화하도록 상기 전극 조립체에 충분한 라디오파 전력을 공급하는 단계.
  26. 제 25 항에 있어서, 상기 조직치료전극의 과열방지를 위하여 상기 라디오파의 전력을 조절하는 단계를 추가로 포함하는 것을 특징으로 하는 전기외과적 조직 건조방법.
  27. 제 25 항 또는 제 26 항에 있어서, 상기 복귀전극은 조직치료전극에 대하여 기부쪽으로 간격을 두고 배치되며, 상기 조직치료전극이 치료받을 조직에 최대로 인접하여 위치하도록 상기 전극 조립체가 수술부위내로 도입되고, 증기주머니는 조직과, 상기 복귀전극은 전기전도성 유체와 각각 접하며, 상기 전극 조립체는 최소한 조직을 증기부식화할 수 있도록 조작되는 것을 특징으로 하는 전기외과적 조직 건조방법.
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KR100895939B1 (ko) * 2005-01-18 2009-05-07 알마 레이저스 엘티디 무선주파수 에너지를 통한 생물학적 조직 가열 방법 및개선된 시스템
KR20150126609A (ko) * 2013-03-07 2015-11-12 아서로케어 코포레이션 전기 수술 시스템 및 방법
KR20190131354A (ko) * 2018-05-16 2019-11-26 주식회사 세종메디칼 외과수술용 의료장치
KR20230135344A (ko) 2022-03-16 2023-09-25 인제대학교 산학협력단 바이폴라 에너지를 이용하여 응고 기능이 동반된 초음파 흡인 간 및 뇌절삭기

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AU703433B2 (en) 1999-03-25
EP0833593A1 (en) 1998-04-08
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DE69611912D1 (de) 2001-04-05
US6027501A (en) 2000-02-22
DE69611912T3 (de) 2005-06-09
MX9800222A (es) 1998-07-31
WO1997000646A1 (en) 1997-01-09
EP0833593B2 (en) 2004-07-28
US6174308B1 (en) 2001-01-16
JPH11507856A (ja) 1999-07-13
AU6132096A (en) 1997-01-22
EP0833593B1 (en) 2001-02-28
ES2154824T3 (es) 2001-04-16
DE69611912T2 (de) 2001-07-19
ES2154824T5 (es) 2005-04-01
AR002569A1 (es) 1998-03-25
CA2224975A1 (en) 1997-01-09

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