KR100273015B1 - 의료용 탐침장치 및 방법 - Google Patents

의료용 탐침장치 및 방법 Download PDF

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KR100273015B1
KR100273015B1 KR1019950700585A KR19950700585A KR100273015B1 KR 100273015 B1 KR100273015 B1 KR 100273015B1 KR 1019950700585 A KR1019950700585 A KR 1019950700585A KR 19950700585 A KR19950700585 A KR 19950700585A KR 100273015 B1 KR100273015 B1 KR 100273015B1
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South Korea
Prior art keywords
high frequency
stylet
tissue
conductive electrode
catheter
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KR1019950700585A
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KR950702848A (ko
Inventor
디. 에드워즈 스튜어트
지 랙스 로날드
에이치.룬드퀴스트 잉게마르
알.샤아키 휴우
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비드아메드,인코포레이티드
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Abstract

본 발명은, 측벽에서 하나 이상의 스틸릿 구멍(140)을 갖고 목포조직에 대해 사전 선택된 조절 가능한 각으로 스틸릿 구멍을 통해 그리고 개입조직을 통해 외향으로 가요성 스틸릿(17)을 향하게 하기 위한 스틸릿 가이드(16)을 갖는 스틸릿 가이드 하우징(50)을 갖는 카테테르로 이루어진 의료용 탐침 장치에 관한 것이다. 전체 카테테르 조립체는 구멍으로부터 개입조직을 통해 목표 조직으로의 새로 운동을 위해 스틸릿 가이드 루멘내에 위치한 스틸릿 및 스틸릿 구멍과 연통하고 있는 스틸릿 가이드 루멘(61)을 포함한다. 스틸릿은 비-전도성 층(60)내서 포함된 전기 전도체일 수 있으며, 전기 전도체는 라디오주파 전극이다.

Description

[발명의 명칭]
의료용 탐침장치 및 방법
[발명의 상세한 설명]
[기술분야]
본 발명은 예를 들어 조직파괴 및 유체성분 전달과 같은 의료적 용도로 인체조직을 관통시키기 위한 독특한 장치 및 방법에 관한 것이다. 상기 장치는 조직에 에너지를 전달하고/거나 성분을 전달하기 위해 선택된 정확한 표적부까지 조직을 관통한다. 본 발명의 장치는 정확한 소정의 부위로 전달 작용을 제한하여, 정상의 주변조직에 대한 외상을 최소화시키고, 더 큰 의료 효과를 달성시킨다. 상기 장치는 카테테르내에 하나 이상의 스타일레트를 지니는 의료 치료를 위해 선태된 부위 또는 기관내에 치료 어셈블리를 정위시키는 카테테르형 장치이고, 상기 스타일레트는 카테테르의 측면내의 스타일레트로부터 주변조직을 통해 치료하고자 하는 표적조직까지 연장되도록 설치된다.
[배경기술]
세포조직의 치료는 일반적으로, 표적조직 및 주변조직 둘 모두가 실질적으로 외상을 입게되는 외과적 방법에 의해서, 표적조직과 의료기구를 직접 접촉시켜야 한다. 종종, 표적조직이 체내에 위치하거나, 표적 조직이 쉽게 손상되는 중요한 인체기관, 신경 또는 다른 부분에 근접되어 있기 때문에, 치료탐침의 정확한 위치선정이 어렵다.
예를 들어, 양성 전립선 이상비대 또는 증생(BPH)이 50세 이상의 남성이 경험하는 가장 일반적 의료 문제점 중 하나이다. 가장 초기 의학부터 전립선 증생으로 인한 요로폐색이 인지되었다. 전립선 증생의 확대는 요도의 압축을 유도하여, 요도의 폐색, 및 빈번한 방뇨, 요량의 감소, 야뇨증, 통증, 불쾌 및 적하를 포함하는 속발성 증상을 유발시킨다. BPH와노화의 연관은 50세 이상의 남성에 있어서 50%를 초과하고, 80세 이상의 남성에 있어서 75% 이상으로 발생 빈도가 증가되는 것으로 입증되었다. 65세 내지 70세의 남성군의 약 65%가 전립선 비대증이 있으며, 이러한 연령의 남성에서, 요도폐색의 증상이 가장 자주 발생한다.
현재, BPH의 효과적인 비외과적 치료법은 입증되지 않았다. 또한, 이용할 수 있는 외과적 수술은 전체적으로 만족스럽지 못한다. 현재 상기 폐색증 질환을 앓고 있는 환자는 몇가지 옵션을 갖는다. 즉, 증상에 계속 잘 대처해야 하거나(보전적 처리), 초기 단계에 약물치료를 하거나, 수술을 해야한다. 미합중국에서 연간 430,000명 이상의 환자가 전립선 조직의 제거를 위해 수술을 받는다. 이것은 임상적인 상당한 증상을 나타내는 남성의 5%미만에 불과하다.
BPH를 앓고 있는 환자는, 종종, 대부분 외과수술에 증가된 위험성을 나타내는 부가적 건강문제가 있는 노인들이다. 전립선 조직의 제거를 위한 외과수술은 마취 관련 이환율, 출혈, 응혈이상, 폐 색전증 및 전해질 불균형을 포함하는 많은 위험과 연관된다. 현재 수행되는 이러한 수술은 또한, 심장 합병증, 방광 천공, 실금, 감염, 요도 또는 방광 협착, 전립선 삭편의 저류, 역행성 사정 및 불임증을 유도할 수 있다. 폐색성 요도증에 대한 현재의 치료옵션의 광범위한 부작용 특성으로 인해서, 환자의 대부분은 이러한 질환의 결정적 치료를 미루고 있다. 이러한 상황은 중요한 결과없이, 전립선에서의 폐색성 병변(방광비대, 수신증, 신장 골반의 이완등)에 대한 2차적인 구조에 심한 손상을 유도할 수 있다. 또한, 외과적 개입을 요하는 시한 증상을 앓고 있는 상당히 많은 수의 환자가 전립선 절제에 대해서 좋지 않은 수술 위험이 있고, 지원자가 부족하다. 또한, 불임증과 같은 위험한 합병증을 원하지 않는, BPH를 앓고 있는 젊은 남성은 종종 외과적 개입을 피하려고 한다. 이와 같이, BPH를 치료하기 위한 개선된 외과적 개입을 피하려고 한다. 이와 같이, BPH를 치료하기 위한 개선된 외과적 및 비외과적 방법의 필요성, 중요성 및 가치가 확실하다.
특히, 무혈절개가 요구되는 경우나, 수술부위가 일반적인 스캘펠이 쉽게 들어갈 수 없지만, 식도, 장 또는 요도와 같은 자연적 인체 구멍을 통한 얇은 기구의 접근을 허용하는 경우에, 인체의 조직을 절제하기 위한 전기 소작법에서 고주파 전류가 사용된다. 그 예로는, 전립선 선종, 방광종양 또는 장 폴립이 포함된다. 이러한 경우에, 고주파 전류는 외과적 탐침에 의해 절단하려는 조직내로 공급된다. 발생된 소산열은 이 지점에서 세포유체의 비등 및 증발을 유발시키며 이때, 세포벽은 파열되고 조직은 분리된다.
원위치에서의 세포조직 파괴방법은, 많은 질병 및 의료적 질환의 치료에 단독으로 이용되거나, 외과적 제거수술에 대한 보조치료로 이용된다. 이러한 치료법은 종종 외과적 수술보다 외상을 더 적게하고, 다른 수술이 불안전한 경우에 유일한 대체일 수 있다. 절제치료 장치는 체액 및 다른 자연적 인체 프로세스의 전도 및 대류력에 의해 비파괴수준으로 빠르게 소산 및 감소되는 파괴 에너지를 이용하는 장점이 있다.
매우 다양한 해부학적 부위 및 기관으로부터 악성, 양성 및 다른 유형의 세포 및 조직을 파괴시키기 위해서, 마이크로파, 고주파, 소리 에너지(초음파) 및 광에너지(레이저)장치, 및 조직파괴 성분이 사용된다. 처리되는 조직에는 분리된 궤양 매스, 더욱 상세하게는, 양선 전립선 증생을 특징으로 하는 전립선, 선 및 간질소결과 같은 기관을 포함한다. 상기 장치는 전형적으로, 도관을 통해 고주파 전극 또는 마이크로파 안테나를 치료영역으로 운반하고, 도관벽을 통해 모든 방향으로 주변 조직내로 확산적으로 에너지를 가하기 위해 사용되는 카테테르 또는 캐뉼라를 포함한다. 심한 외상은 종종, 상기 세포파괴 과정동안 도관벽에 의해 지속되고, 몇몇 장치는 도관벽에 대한 외상을 감소시키기 위해 냉각수단을 마이크로파 안테나와 조합시킨다. 상기 장치의 사용으로 전립선을 치료하는데 있어서, 예를 들어, 요도를 수축시키는 조직을 제거하기 위해 열에너지가 요도의 벽을 통해 주변 전립선 세포내로 운반된다. 대표적으로 레이저로 부터의 광에너지가 요도의 벽을 통해서 “연소”시킴으로써, 전립선 조직 표적 부위에 운반된다. 상기 과정에서 도관벽의 건강한 세포 및 소결절과 도관벽 사이의 건강한 조직이 또한 무차별하게 파괴되고, 일부 전립선 기능의 불필요한 손실을 유발시킬 수 있다. 더욱 더, 몇몇 마이크로파 장치의 부가된 냉각기능은 장치를 복잡하게 하고,상기 냉각장치를 수용하도록 장치가 충분히 커야하는 것을 필요로 한다.
의료목적으로 특정조직에 액체를 적용하는 것은 중간 조직에 외상을 주지 않으면서 운반을 가능하게 하고 특정 표적조직으로 제한된 운반을 수행하는 능력에 의해 제한된다. 편재된 화학치료, 약물주입, 콜라겐 주사 또는 광, 열 또는 화학약품에 의해 활성화되는 제제의 주사는, 특정 표적조직에 유체공급 카테테르 오프닝을 편리하고 정확하게 위치시킬 수 있는 장치에 의해 매우 촉진된다.
[발명의 설명]
본 발명의 주요 목적은 중간 조직을 통해 조직파괴 및/또는 성분전달과 같은 의료 작용을 위해 선택된 정확한 표적조직까지 조직을 관통시키고, 이러한 작용을 정확한 소정의 부위로 제한하여, 외상을 최소화시키고 더큰 의료적 이점을 얻기 위한 장치 및 방법을 제공하는 데에 있다.
본 발명의 하나의 주요 목적은 표적 조직내로 치료적 에너지를 직접 전달시키면서, 주변조직에 대한 영향을 최소화시키는 인체조직의 조직파괴장치 및 방법을 제공하는데에 있다.
본 발명의 또다른 하나의 주요 목적은 인체중의 특정위치에 더 정확하고 쉽게 유체 치료제, 특히 유동성 액체를 도입시키기 위한 장치 및 방법을 제공하는 데에 있다.
본 발명의 또다른 목적은 치료하고자 하는 표적 조직 및 주변 조직들 모두에게 발생되는 온도 및 그밖의 상태에 대한 더 많은 정보를 조작자에게 제공하는 열적파괴 장치를 제공하는 데에 있다. 또한, 상기 장치는 스타일레트의 물리적 위치 및 조직파괴 과정의 변수에 대해 더 큰 제어를 제공할 것이다.
요약하면, 본 발명의 의료용 탐침장치는 제어말단 및 탐침말단을 갖는 카테테르로 이루어진다. 탐침말단은 측벽에 하나 이상의 스타일레트 출구를 갖고, 스타일레트 출구를 통해서 그리고 표적 조직에 대해 소정의 각으로 중간 조직을 통해 가요성 스타일레트를 외향으로 향하게 하는 가이드 수단을 갖는 스타일레트 가이드 하우징을 포함한다. 하우징은 일련의 이러한 출구를 포함할 수 있다. 소정의 각도는 스타일레트 가이드 하우징의 중심축에 대해 바람직하게도 20° 내지 160°이다. 전체 카테테르 조립체는 각각의 스타일레트 구멍과 연통된 하나 이상의 스타일레트 가이드 루메나(Lumena), 및 각각의 출구로부터 중간 조직을 통해 표적 조직까지 세로로 이동하도록 상기 각각의 스타일레트 가이드 루메나에 위치한 스타일레트를 포함한다.
스타일레트는 비전도층내에 싸여있는 전도체이며, 전도체는 고주파 전극이다. 바람직하게는, 비전도층은 표적 조직에서 전기 전도체 표면의 선택된 부분을 노출시키도록 전기 전도체에 대해 축방향 또는 세로방향으로 이동할 수 있는 슬리브이다.
추가의 구체예에서, 스타일레트는 캐뉼라를 통해 연장되는 세로중심 처리유체 공급 루멘을 갖는 캐뉼라이고, 카테테르는 처리유체 공급루멘과 연통된 처리유체 운반 루멘을 갖는다.
버블 또는 초음파 변환기와 같은 초음파 반사기가 탐침말단 또는 스타일레트의 일부에 끼워지거나 또는 다른식으로는 부착되어, 카테테르 및 스타일레트를 정위시키는데 이용되는 신호를 제공한다.
스타일레트가 고주파 전극을 포함하는 경우, 최적으로 더어미스터(thermistor) 또는 광섬유 케이블이 탐침말단, 스타일레트 가이드 하우징 및/또는 스타일레트에 부착될 수 있다.
하나의 바람직한 구체예에서, 스타일레트 가이드는 스타일레트 출구에서 카테테르중의 축방향 배향으로부터 굴곡된 부분을 통해 측면배향에 이르는 스타일레트 경로를 한정하며, 굴곡된 경로는, 임의적으로, 바람직한 각으로 전개되고 연장된 스타일레트를 비꺼나가게 하기에 충분한 반경으로서, 카테테르의 직경에 따라 약 0.5㎝이하의 반경을 갖는다. 스타일레트 가이드 수단은 스타일레트 출구로부터 이격된 한 방향으로 연장되는 제1굴곡된부분 및 제1굴곡된 부분으로부터 스타일레트 출구까지 연장한 제2굴곡된 부분을 형성할 수 있다.
다수의 스타일레트를 배치하기 위해서, 스타일레트 가이드 수단은 굴곡된 부분을 통해 카테테르내의 평행한 축방향 배향으로부터 스타일레트 출구의 측면배향에 이르는 2 이상의 비교차 스타이레트 경도를 형성시키며, 상기 스타일레트 출구는 180°이하의 각을 형성하는 축을 갖는다. 한 구체예로서 전립선염을 치료하기 위해서, 스타일레트 구멍축은 90°미만, 바람직하게는 50° 내지 70°의 각을 형성한다.
비전도성 슬리브는 유도 팁, 경질 근위 제어단면, 및 유도 팁으로부터 경질 근위 제어단면으로 연장한 가요성 부분으로 이루어질 수 있으며, 이에 의해 슬리브는 굴곡된 경로를 통해 축방향 배향으로부터, 스타일레트 출구를 통해 외향으로 연장한 배향으로 연장될 수 있다. 유도 팁은 이것의 말단을 향해 내향으로 점점 좁아질 수 있다. 가요성 부분은 임의적으로 나선형 코일일 수 있다. 나선형 코일이 전도성 물질로 이루어진다면, 이것은 외부 비전도성 물질내에 포함될 수 있다.
카테테르의 원위 부분은 이것의 근위 부분 보다 더 가요성이어서, 굴곡된 도관을 용이하게 통과한다.
한 구체예에서, 제어핸들이 스타일레트에 부착되고 스타일레트 가이드 수단에서의 스타일레트의 세로 이동을 위해 핸들과 맞물리는 스타일레트 이동수단 및 카테테르의 제어 말단에 부착된다. 스타일레트 운동수단은 스타일레트 가이드 수단에서의 스타일레트의 세로운동으로 수동운동을 전환시키기 위해 수동 맞물림 수단을 포함한다.
전기 전도체가 비-전도성 슬리브 중의 축방향 운동을 갖는 구현에서는, 비-전도성 슬리브 운동수단은 비-전도성 슬리브에 부착되고, 전기 전도체 운동수단은 그안에 포함된 전기 전도체에 부착된다. 비-전도성 슬리브 운동수단은 수동운동을 스타일레트 가이드 수단에서 비-전도성 슬리브의 세로운동으로 전환시킨다. 전기 전도체 운동수단은 수동운동을 비-전도성 슬리브에서 전기 전도체의 세로운동을 전환시킨다. 비-전도성 슬리브 운도우단 및 전기 전도체 운동수단은 그 위에서의 운동을 위한 핸들을 맞물린다. 비-전도성 슬리브 운동수단 및 전기 전도체 운동수단은 분리 및 그에 대한 연동 둘 모두를 위해 핸들상에 고정된 분리된 인접수동 운동수단을 포함한다. 하우징은 이것의 벽을 통한 적어도 2개의 평행한 세로슬롯을 가질 수 있으며, 수동 운동수단은 각각 하우징의 내부에서 세로슬롯중 하나를 통해 연장한 컨넥터까지 슬라이드에 연결된 표면을 맞물리게 하는 핑거를 포함하며, 컨넥터는 각각의 비-전도성 슬리브 또는 전기 전도체에 부착된다.
표적조직에 파괴 에너지를 가하기 위한 본 발명은 우선, 처리하려는 조직에 인접한 영역에 카테테르를 도입시키는 것을 포함한다. 전기 전도체는 카테테르로 부터 주변조직을 통해 파괴시키려는 표적 조직내로 이동한다. 전기 전도체는 슬리브를 둘러싸는 조직에서 전도체로 부터의 에너지의 상당한 전달을 방지하기 위해 비-전도성 슬리브에 의해 둘러싸인 전도성 표면으로 이루어진 와이어 또는 튜브일 수 있다. 전기 전도체에 의해 생성된 전류 또는 전자기장으로 부터 표적조직에서 열이 발생한다. 처리되는 조직의 부피는, 처리하려는 인체조직에서 선택된 길이의 전극을 노출시키도록 비-전도성 슬리브를 이동시킴으로써 조절되며, 전극의 나머지 부분은 개입조직을 보호하도록 슬리브에 의해 차폐되어 유지된다. 에너지 전달의 양 및 지속 기간은 또한 처리하려는 조직의 부피를 조절하도록 변할 수 있다.
전기 전도체는 장치의 위치선정을 촉진시키기 위해 위치된 카테테르 샤프트내에 혼입된 섬유광학 관찰 시스템을 사용하여 위치될 수 있다. 이러한 시스템은 또한, 루미네어션 및 관찰을 위한 분리 광학체 및 관찰영역을 플러싱시키기 위한 플러싱 유체 공급도관을 포함할 수 있다.
전기 전도체는 또한, 표적조직으로 부터 일정거리에 위치하거나 또는 전기 전도체 또는 비-전도성 슬리브에 의해 지지된 초음속 변환기로 부터의 초음속 영상화를 사용하여, 처리하려는 조직에 위치할 수 있다.
전기 전도체 또는 비-전도성 슬리브에 의해 지지된 온도 감지기를 사용하여 절제 치료동안 가열의 정도가 모니터되고 조절될 수 있다.
전립선과 같은 표적조직을 치료하기 위한 본 발명의 방법의 또다른 구현에서는, 카테테르의 측벽에서 카테테르 출구를 통해 그리고 요도벽 및 주변조직을 통해, 처리하려는 전립선 표적 조직내로 카테테르로 부터의 2개의 가요성 스타일레트가 이동하며, 카테테르 출구은 180° 미만의 각 및 일부조직에서의 치료를 위해 90° 미만의 각을 형성하는 축을 갖는다.
또다른 추가의 구현에서는, 접지판이 피부상에 위치하여, 절제하려는 표적 조직을 통한 경로에서 하나 이상의 전극으로 부터 통하는 전류를 안내한다.
[도면의 간단한 설명]
제1도는 치료를 위한 위치에 있는 본 발명의 장치의 한 구체예로서 남성의 하체를 해부학적으로 도시한 개략적 횡단면도이다.
제2도는 다수의 연장된 스타일레트를 갖는 본 발명의 카테테르의 말단 하우징 부분의 측면도이다.
제3도는 제2도에 도시한 말단 하우징 부분의 단면도이다.
제4도는 본 발명의 카테테르의 또 다른 구체예의 측단면도이다.
제5도는 본 발명에 따르는 RF 전극 스타일레트의 한 구체예의 횡단면도이다.
제6도 및 제7도는 스타일레트 가이드 각을 조절하기 위한 스타일레트 가이드 시스템을 갖는 본 발명의 카테테르의 한 구체예의 횡단면도이다.
제8도 및 제9도는 본 발명의 방법에 따른 치료로부터 중간 조직을 차폐시키면서, 파괴를 위한 표적조직을 치료하기 위해 위치한 부분적으로 수축된 슬리브를 갖는 제4도에 도시한 RF 전극 스타일레트의 상세한 개략적 횡단면도이다.
제10도는 본 발명에 따른 제어 시스템 수동 카테테르 제어유닛 및 카테테르의 조립체의 개략도이다.
제11도는 본 발명의 시스템의 수동제어 시스템의 한 구체예의 등각 투영도이다.
제12도는 본 발명의 시스템의 전력 및 제어콘솔의 한 구체예의 등각 투영도이다.
제13도는 본 발명의 장치의 또 다른 4-탐침 구체예의 평면도이다.
제14도는 제13도에 도시된 카테테르의 원위 탐침말단의 측면도이다.
제15도는 선(15-15)를 따라 자른, 제14도에 도시된 장치의 탐침말단의 횡단면도이다.
제16도는 제15도의 선(16-16)를 따라 자른, 본 발명의 장치의 탐침말단의 부분 횡단면도이다.
제17도는 중심축을 따라 자른, 제13도에 도시된 장치의 제어말단의 횡단면도이다.
제18도는 선(18-18)를 따라 자른, 제7도에 도시된 장치의 제어말단의 횡단면도이다.
제19도는 선(19-19)를 따라 자른, 제17도에 도시된 장치의 제어말단의 횡단면도이다.
제20도는 제17도 및 제18도에 도시된 구체예의 비전도성 슬리브 접속기의 측면도이다.
제21도는 선(21-21)를 따라 자른, 제20도에 도시된 비전도성 슬리브 접속기의 횡단면도이다.
제22도는 제17도 및 제19도에 도시된 구체예의 전동체 접속기의 측면도이다.
제23도는 선(23-23)를 따라 자른, 제22도에 도시된 전도체 접속기의 횡단면도이다.
제24도는 중심축을 따라 자른, 제14도 및 제15도에 도시된 비전도성 슬리브의 원위 말단의 횡단면도이다.
제25도는 본 발명의 RF 절제 카테테르의 또 다른 구체예의 2스타일레트의 정면도이다.
제26도는 본 발명의 스타일레트 팁의 한 구체예의 정며도이다.
제27도는 제26도에 도시된 단일접지 전극 팁의 측면도이다.
제28도는 제27도에 도시된 전극 팁의 단면도이다.
제29도는 또 다른 이중접지 전극팁의 측면도이다.
제30도는 제29도에 도시된 전극팁의 단면도이다.
제31도는 제25도의 절제 카테테르의 핸들부분의 정면도이다.
제32도는 바닥 커버판이 부분적으로 제거된, 선(32-32)를 따라 자른, 핸들 부분의 측면도이다.
제33도는 바닥 커버판이 제거된, 제31도에 도시된 핸들부분의 저면도이다.
제34도는 제33도에서 선(34-34)을 따라 자른 핸들부분의 횡단면도이다.
제35도는 스타일레트 및 슬리브가 수축위치에 있는, 제32도에 도시된 핸들부분의 중심부분의 횡단면도이다.
제36도는 연장된 위치에서 스타일레트 및 슬리브를 갖는, 제32도에 도시된 핸들 부분의 중심부분의 횡단면도이다.
제23도는 연장된 위치에서 스타일레트 및 이로부터 부분적으로 수축된 슬리브를 갖는, 제32도의 핸들부분의 중심부부의 횡단면도이다.
제38도는 본 발명의 중첩된 절제 영역 방법에 대한 스타일레트 배향을 나타내는 전립선내에서의 2 스타일레트의 전개 개략도이다.
[발명을 수행하기 위한 가장 우수한 방식]
본 발명의 장치는 표적 조직 근처에 위치한 카테테르로 부터의 치료, 파괴 또는 샘플링을 위해 표적 조직에서의 치료 스타일레트의 정확하게 조절된 위치선정을 제공 한다.
용어 “스타일레트”은 카테테르 출구로부터 정상조직을 통해 표적 조직으로 통과하기에 적합한 고형 및 중공탐침 둘 모두를 포함하는 것으로 정의된다. 스타일레트는 조직을 통해 용이하게 통과되도록 형상화된다. 이것은 고형 와이어, 얇은 로드 및 다른 고형형태일 수 있거나, 유체를 일정부위에 도입시키거나, 일정 부위로부터 물질을 제거하기 위한 세로 루멘을 갖는 얇은 중공튜브 또는 그밖의 중공 형상일 수 있다. 스타일레트는 또한 얇은 중공튜브 또는 그밖의 중공 형상일 수 있으며, 이것들의 중공 루멘은 보강 또는 기능 로드 또는 튜브를 함유한다. 스타일레트는 바람직하게는, 날카로운 말단을 가져서, 이것이 조직을 통해 표적 조직으로 밀어질 경우에 저항성 및 외상을 감소시킨다.
스타일레트는 선택된 조직의 다양한 의료적으로 바람직한 치료를 제공한다. 고주파 전극로서, 이것은 표적 조직을 절제 또는 파괴시키기 위해 사용될 수 있다. 중공튜브로서, 이것은 액체와 같은 치료용 유체를 표적 조직에 전달하기 위해 사용될 수 있다. 액체는, 용액 또는 액체 중의 고체, 예를 들어, 콜로이드 입자의 현탁액일 수 있다. 스타일레트는 매우 얇기 때문에, 이것은 정상 조직의 외상을 최소화하면서 카테테르로부터 중간의 정상조직을 통해 유도될 수 있다.
본 발명의 장치 및 방법은 인체기관내 및 외부 둘 모두에서, 인체전체에 걸쳐 의료적으로 표적화된 조직의 세포를 파괴시키기 위해 적합한 더욱 정확하고 조절된 치료를 제공한다. 상기 장치 및 방법은 양성 전립선 증생(BPH)를 치료하기에 특히 유용하고, 상기 장치 및 이것의 사용은 이들의 설명을 간단하게 하기 위해서, BBP에 대해 하기에서 설명된다. 상기 장치 및 방법이 경피 및 내시경 카테테르에 의해 접근될 수 있는 어떠한 인체공동 또는 조직위치에서 인체조직을 파괴시키기 위해 사용될 수 있고, 전립선으로 제한되지 않음이 당업자들에게는 자명할 것이다.
모든 상기 기관 및 조직에서 상기 장치 및 방법의 응용도 본 발명의 범위내에 포함된다.
BPH는 전립선을 팽창시키고 전립선 요도의 오프닝을 압축시키는 선 및 기질 소결절을 형성시키는 전립선 중의 세포의 양성복제 및 성장으로 부터 발생하는 질환이다. 선 소결절은 주로, 전이영역내에 집중되고, 기질 소결절은 요도근처 영역에 집중된다. 상기 질환의 통상적인 치료는 전체 전립선 샘의 외과적 제거, 선종의 디지탈 제거 뿐만 아니라, 조직을 제거하고 통로를 넓히기 위한 요도관 및 전립선의 요도교차 절제를 포함한다. 후자의 방법과 관련한 상당하고 심한 합병증은 의학적 불임증이며, 더욱 최근에는, 레이저 치료가 사용되어 조직을 제거하여, 체액의 손실 및 출혈을 제한하였다. 벌룬이 또한 열을 사용하거나 사용하지 않으면서 요도내에서 팽창되어 이것의 직경을 확장시켰지만, 상당히 제한 받는 것으로 밝혀졌다.
마이크로파 치료는, 전립선 요도내에 마이크로파 안테나를 위치시키고, 마이크로파 장으로 요도를 둘러싼 조직에서 열을 발생시킴으로써 몇가지 성공이 있는 것으로 제공되었다. 냉각제가 중공 카테테르 샤프트내에 사용되어 요도벽의 온도를 감소시킨다. 이것은 바로 인접한 조직을 냉각시키면서 더 먼 전립선 조직에서 열을 발생시키기 위해 복잡한 메카니즘을 필요로 한다. 상기 기술은 마이크로파 고열법과 유사하다. 유사하게는, 요도내에 위치한 전극에 의한 고주파 조직 파괴는 사용이 제한되는데 그 이유는 필연적으로 요도벽을 파괴온도에 노출시키기 때문이다. 이것을 피하기 위해서, 요도를 보호하기 위해 필요한 저온셋팅은, 어떤 유용한 효과를 발생시키기 위해 필요한 치료시간이 예를들어 3시간 이하의 에너지 사용까지 과다하게 연장될 정도로 낮아야 한다.
본 발명의 장치의 한 구체예는 요도를 통해 전립선에 접근하고, 파괴하려는 조직 또는 소결절내에 직접 RF 전극 스타일레트를 위치시킨다. 요도로 부터 표적 조직까지 연장한 스타일레트 전도체 부분은 슬리브에 인접한 조직이 RF 전류에 노출되는 것을 방지하는 세로로 조절할 수 있는 슬리브 차폐물내에 포함된다. 절제 파괴는 파괴를 위해 표적화된 조직, 즉, 수축을 야기시키는 조직으로 한정된다. 본 발명의 다른 면들은 본 발명의 장치 및 방법의 도면 및 이를 설명하는 상세한 설명으로 부터 명백해질 것이다. 상기 방법이 인체출구를 통한 경피접근을 위해 인체의 많은 부분에 사용될 수 있음이 당업자에게는 자명할 것이다.
제1도는 본 발명에 따른 장치 및 방법을 사용하는 남성의 하체를 해부학적으로 도시한 개략적인 단면도이다. 요도(2)는 전립선(6) 및 생식기관(8)을 통해 방광으로 부터 연장된다. BPH는 전립선내의 기질세포 및 양성 선의 증식에 의해 주로 발생되는 전립선 요도 부분을 압축시키는 것을 특징으로 하는 질환이다. 이러한 소결절은 요도직경을 한정하는 요도의 벽을 안쪽으로 가압하고, 전립선을 확장시키기도 하면서 정상조직을 바깥쪽으로 가압할 수 있다. 전립선 제거의 종래의 간단히 치료는 레이저 조직파괴 또는 절제에 의하거나, 세포 사멸을 유발시키는 온도로 요도를 둘러싼 조직을 평창 및 가열시킴으로써 요도로부터 조직을 제거하여, 그 루멘을 확장시키는 것을 포함된다. 후자의 방법은 전립선의 스웰링 또는 비대를 감소시키고, 최소한 이전의 직경으로 요로를 회복시키고자 하는 것이다.
본 발명에 따른 방법에 있어서, 스타일레트 가이드(16)가 있는 카테테르(14)가 요도를 통해 전립선으로 위쪽으로 통과된다. 가이드(16)의 위치는 예컨대, 항문(22)을 통해 전립선 근처의 직장으로 삽입되는 종래의 초음파 변환기(18)로부터 수신된 신호에서 얻어지는 초음파 영상을 사용하여 정확히 제어된다. 가이드(16)는 초음파 영상에서 정확한 위치로 스타일레트(17)을 용이하게 위치시킨다. 선택적으로 스타일레트 가이드를 위치시키는데 광섬유를 사용할 수도 있다.
카테테르(14)의 최종위치는 하나 이상의 팽창기구(30 및 32)를 가질 수 있다. 스타일레트 슬리브(36)는 보호하고자 하는 요도 및 다른 조직을 통해 연장될 수 있으며, 도면에 도시한 바와 같이, RF 전극(38)이 표적조직(28)으로 깊게 연장될 수 있다.
제2도 및 제3도는 각각 본 발명에 따른 카테테르의 한 구체예의 최종위치를 나타내는 측면도 및 단면도이다. 하나 이상의 스타일레트 출구(40)이 팽창되지 않은 환형 기구들(30 및 32) 사이에 위치한다. 초음파 변환기(42)가 전립선내의 스타일레트 가이드 하우징(16)을 정확히 위치시키는데 사용될 수 있는 신호 및 영상을 발생하는 최종단부(44)에 위치할 수 있다. 또는 스타일레트 가이드의 소노 그래프 위치를 보조하도록 말단 하우징으로 외생성 버블이 혼입될 수도 있다. 종래의 더어미스터, 열전쌍 또는 광섬유일 수 있는 하나 이상의 온도센서(46)가 카테테르를 따라 위치되어, 스타일레트 영역의 양측에 인접하여, 바람직하게는 양면에서 요도의 온도 프로파일을 제공한다. 이러한 온도 프로파일은 요도벽의 온도가 세포파괴가 일어나는 레벨에 도달하지 않게 할 수 있다. 상기 도면은 두 기구(30 및 32)와 연장된 위치에서의 6개의 스타일레트(36)을 나타낸다.
카테테르는 처치하고자 하는 조직쪽으로 하나 이상의 스타일레트를 배향시키기 위해 스타일레트 배치에 앞서 중심축을 회전할 수 있다. 카테테르 말단 하우징(16)이 전립선 요도내의 치료위치로 진행한 후, 환형기구(30 및 32)가 카테테르를 안정화시키고 요도 루멘을 팽창시키기 위해 요도내에서 팽창될 수 있다. 스타일레트는 치료의 목적이 되는 조직내에 위치할 때까지 요도벽 및 중간조직을 통해 연장된다. BPH 치료를 위한 표적 조직은 소결절, 정상조직 또는 이들 모두일 수 있다. 출구(40)로 유도하는 스타일레트 통로는 그 말단축이 평면내의 카테테르의 중심축에 의해 약 20° 내지 160°, 바람직하게는 30 내지 150°일 수 있는 각도를 형성하는 배향을 갖는다. 본 발명의 한가지 구체예와 관련하여 이하에서 보다 더 상세히 기재하는 바와 같이, 비전도성 슬리브가 표적 조직을 전류에 의해 45℃이상, 바람직하게는 55 내지 99℃ 온도로 조절된 가열에 노출되도록 이동한다.
제4도는 본 발명에 따른 하나의 구체에의 연장된 스타일레트를 갖는 카테테르의 단면도이며, 제5도는 제4도에 도시된 스타일레트 팁의 확대 단면도이다. 이 구체예에 있어서, 카테테르(48)은 돌출부(52)가 있는 스타일레트 가이드 하우징(50)에 연결된다. 스타일레트954)는 튜브(58)내에 동축으로 위치하는 고체 코어 니들(56)을 포함하여, 이는 니켈-티탄 합금, 강화 강전, 스테인레스강, 및 베릴륨-구리 합금등과 같은 고가요성 전도성 금속으로 이루어지는 것이 바람직하다. 니켈-티탄 및 유사한 고가요성 성형된 회복성 합금이 바람직하다. 니들(56)은 튜브(58)내에서 축방향 또는 세로방향으로 이동가능하다. 튜브(58)는 튜브(58)를 따라 세로방향으로 이동 가능한 비전도성 슬리브(60)내에 마련된다. 가이드 하우징(50)은 가요성 스타일레트의 세로방향 진행을 허용하도록 곡굴곡되는 가이드 채널(61)을 갖는다.
슬리브(60)는 세로방향 돌출튜브(61)와 연결된 환형 실린더(62)에 결합된다. 돌출튜브(64)의 길이방향 이동은 튜브(58)를 따라 슬리브(60)의 상응하는 길이방향 이동을 유발시킨다. 슬리브 이동은 주변조직에 노출된 튜브(58) 및 니들(56)의 길이를 변경 및 제어하고 표적조직에 전달된 에너지의 양을 조적하는데 사용된다. 슬리브(60)의 재질, 절연성, 유전특성 및 두께는 전도체로 부터 조직을 차단함으로써 전도체와 접촉하는 조직으로 가열 에너지 전달을 방지하도록 선택된다. 조직이 고주파 전류(300 내지 750 ㎑)를 사용하여 가열되는 경우, 슬리브(60)는 조직과 전류 및 정전용량이 결합하는 것을 방지하는데 필요한 충분한 두께를 가져야 한다.
제6도 및 제7도는 스타일레트 가이드 각도를 조정하기 위한 스타일레트 가이드 시스템을 가지는 본 발명에 따른 카테테르의 구체예를 부분적으로 나타내는 도면이다. 스타일레트 가이드 하우징(124)는 스타일레트 출구(126)를 지닌다. 가이드 하우징(124)내에서, 스타일레트 정위 블록(128)은 토크및 돌출 로드(130)의 작용하에서 축방향 운동을 위해 위치한다. 스타일레트 정위 블록(128)은 스타일레트(132)를 포함하는 곡선형 스타일레트 루멘을 갖는다. 선택적으로, 낮은 마찰성의 가요성 가이드 튜브(134)는 정위 블록(128)로 부터 출구(126)까지 연장되어 있다. 제6도에 나타낸 위치에서, 정위 블록(128)이 토크 및 돌출 로드(130)의 작용하에서 축방향 이동을 위해 위치된다. 정위블록(128)이 가이드 하우징의 중심축에 대하여 약 20°, 바람직하게는 30° 내지 90°의 예각(b)으로 연장되도록 스타일레트를 위치시키면서 들어간 위치에 정위블록(128)이 위치한다. 블록(128), 가이드 튜브(134) 및 출구(126)이 점선경로(136)를 따라 조직으로 스타일레트(132)를 진행되게 한다.
제7도에 도시된 바와 같이, 정위블록(128)의 진행이 가이드 튜브(134)를 통해 작은 직경을 가지는 곡선경로를 통해 출구(126)으로 스타일레트(132)을 밀어낸다. 스타일레트(132)은 가이드 하우징 축에 대하여 약 160°만큼의 큰 둔각 “b”으로 배향된다. 이러한 구조에 있어, 가이드 블록(128), 가이드 튜브(134) 및 출구(126)을 통한 스타일레트의 진행은 점선경로(138)을 따라 조직으로 스타일레트를 배향시킨다.
제6도 및 제7도에 도시된 바와 같이, 스타일레트(132)의 각도 돌출은 스타일레트 가이드 하우징의 중심축을 통한 평면내의 광범위한 각도에 걸처 배향될 수 있다. 중심축을 중심으로 토크 및 돌출 로드(130)가 회전하면 축평면의 바깥 방향으로 스타일레트의 회절 및 스타일레트 가이드 하우징의 상응하는 회전이 유발된다는 것이 명백하다. 이는 도관에서의 적정 위치로의 카테테르(124)의 축방향 이동 및 그 중심축을 중심으로 한 카테테르의 회전과 복합되어, 매우 다양한 스타일레트 배향각을 형성시킨다. 이러한 이동들을 복합하면 스타일레트가 카테테르로부터 임의의 각도에서 표적 조직으로 진행될 수 있는 스타일레트 각도의 선택의 폭이 넓어진다.
제8도 및 제9도는 제4도에 도시된 RF 전극 스타일레트의 사용시 개략적인 단면도이다. 카테테르가 요도에 위치한 후, 스타일레트(54)가 치료되는 표적 조직(73)으로 전립선 요도를 통해 스타일레트 가이드 하우징(50)으로 부터 진행된다. (점선으로 표시) 스타일레트 슬리브(60)은 표적 조직(73)에서 위치되는 RF 전극의 일부분을 드러내면서 제8도에 도시된 위치로 들어간다. RF 전류는 전극(56 및 58)으로 부터 조직(73)을 통해 종래의 접지판(도시하지 않음)으로 배향된다. 선택된 예에서, 동일한 전극으로서 하나 이상의 스타일레트 및 활성전극으로서 다른 스타일레트를 사용하여 보다 지향된 절제를 할 수 있으므로, 접지판을 사용하지 않고 쌍극자를 완성하는데 스타일레트만을 사용한다. RF 처리는 표적 조직(73)내의 세포가 파괴될 때까지 계속된다.
제9도는 상기 공정에 이은 선택적인 제2단계로 제8도에 상응하는 개략적인 단면도이다. 표적 조직(73)내의 파괴 후에, RF 전극 슬리브(60)은 전립선 요도벽(71)을 통해 표적 조직으로 부터 유도하는 일정길이의 RF 전극(74)을 노출하면서, 스타일레트 가이드 하우징(50)으로 스타일레트 전극(58)을 따라 끌려들어갈 수 있다. 충분한 RF 전류가 전극(58)의 전체 노출면과 직접 접촉하여 조직(76, 도시하지 않음)의 표면을 소작시키는데 사용된다. 예컨대, 이는 표적 조직의 세포를 파괴시키는데 사용되는 것보다 더 높은 전압 및 더 짧은 시간의 치료에 의해 얻어질 수 있다. 스타일레트는 표적 조직(73)의 영역으로부터 전립선 요도로 유도하는 회수관을 이탈하면서 하우징(50)으로 완전히 회수된다. 이러한 과정은 치료 과정중에 처리된 표적 조직(73)의 생성물을 배출시킬 수 있다.
본 발명에 따른 횡단요도 니들제거(TUNA) 방법은 BPH로 알려진 질병 또는 양성 전립선 증생을 앓고 있는 사람에서 일어나는 전립선의 증생조직에 고주파를 전달할 수 있는 과정이다. 이러한 과정은 수축성 조직치료에 한하고 정상 전립선 조직은 그대로 두는 능력을 선택적으로 제공하는 최초의 횡단 요도 과정인 것에 특징이 있다. 이러한 과정은 또한, 특히 BPH로 인한 요도방해를 완화시키는 공지된 과정에서 비교할 때, 주변 전립선 요도에 가해지는 외상을 최소화 한다. 이러한 과정은 환자가 느끼는 통증의 정도 및 에너지 전달율에 따라 국소 마취하에 수행될 수 있다. 국소마취가 적합할 때, 치료는 치료실에서 수행될 수 있다. 구부 마취는 K-Y 젤리와 혼합된 리도카인과 같은 국부 마취제를 포함하는 윤활제 형태로 전달 또는 도포될 수 있다.
실질적인 통증을 환자가 느끼고 있다면, 환자는 피부국소 마취에 부가하여 진정을 요하게 된다. 이러한 과정은 외래환자에 기초하여 제공될 수 있으며, 단기(2-6시간)관찰을 필요로 한다. 치료과정 및 환자가 더 이상의 통증제어를 필요로 하는 경우, 척수마취 또는 일반마취가 이용될 수 있다. 이는 치료과정이 수술실에서 행해지며, 회복실을 필요로 하며, 특정의 경우 입원이 필요할 수도 있다. 공지의 전립선 절제(TURP)방법은 일반적으로 일반적인 마취나 척수마취를 사용할 필요가 있으며, 치료후에 입원치료를 요한다.
본 발명에 따른 BPH 방법은 본 발명의 RF 전극 스타일레트 구체예를 사용하여 하기의 방법으로 수행될 수 있다. 남성환자에게 일반적으로 관장기 또는 하제를 필요로 하는 적합한 전처리제를 제공한다. 이는 직장 초음파 프로브를 위치시키고 검사를 더 좋게 하기 위한 수단의 직장원개를 께끗히 하기 위한 것이다. 이어서, 적합한 마취제를 투여한다. 종래의 접지판을 환자와 접촉하게 위치시킨다. 직장 프로브를 전립선 레벨에 삽입하여 전립선의 초음파 영상을 얻는다. 과정은 직장 초음파를 사용하지 않고 조작자의 임의로 적접적인 가시화 방법을 사용하여 행할 수 있다. 요도 카테테르는 폴리(Foley) 카테테르를 삽입하기 위하여 사용되는 것과 유사한 방식으로 삽입한다. 먼저 귀두 및 음경 샤프프를 베타딘 또는 다른 살균제로 소독한다. 사타구니 인접 영역의 나머지 부위는 일반적인 방식으로 살균타월로 싼다. 무균 또는 살균기술을 사용하여, 페니스의 축을 한 손에 쥐고 카테테르를 요도로 삽입하고 전립선 요도내의 바람직한 위치에 다다르게 진행 시킨다. 요도를 통과하는 동안 카테테르의 이동이 초음파 영상으로 직접 모니터된다. 광섬유로 직접 가시화하는 경우, 적합한 랜드마크를 표시하여 정구 및 방광의 목부분등을 확인한다. 이 단계에서 이것이 일찍 행해지지 않으면, 카테테르와 제어 어셈블리 사이의 다양한 전기적 및 기계적 결합이 유발된다.
RF 전극 스타일레트를 선택된 표적 조직으로 직접 보거나 초음파 영상으로 선택된 조직으로 전달한다. 치료되는 목적영역으로 스타일레트 가이드 부분을 배향기키는데 필요한 만큼 카테테르를 잡아당기거나 진행 및 회전시킨다. 스타일레트, 바람직하게는 절연 슬리브 또는 덮개에 완전히 둘러싸인 스타일레트는 표적 조직으로 전립선 조직을 통해 이동하고 바람직한 깊이로 조직을 관통하면서 전립선 요도의 상피 라이닝을 출구 뚫고 관통한다. 국부 마취제는 스타일레트가 진행하면서 스타일레트의 중심 루멘을 통해 표적 조직으로 침투될 수 있다. 절연 슬리브는 표적 조직내에 RF 전극의 정확히 선택된 길이를 노출시키는데 필요한 양을 잡아당긴다. 이 양은 바람직한 정도 및 부피의 조직 파괴가 수행되도록 선택된다. 이 부피는 표적 조직내의 전극 스타일레트의 상대적인 위치 및 제거될 표적 조직의 크기에 따라 선택된다. 슬리브가 회수되는 거리는 눈금과 같은 종래의 측정장치를 사용하여 몸체외에서 측정될 수 있다.
전극 스타일레트가 종래의 스위치를 근접시킴으로서 RF 에너지원으로부터 에너지를 공급받는다. 바람직하게는 시간 및/또는 전력레벨이 제어 유니트에 의해 설정된다. RF 에너지는 직장 초음파 영상에 의해 파괴 병변의 진행을 모니터하면서 소정 시간동안 표적 조직으로 전달된다. 임피던스도 모니터되며, 초기 설정치를 초과하는 경우, 전력공급이 감소 또는 종결된다. 요도 라이닝, 슬리브 및 노출된 전극에 인접한 카테테르 표면의 온도가 카테테르에 부착된 온도 센서에 의해 모니터되어 손상피부를 정확히 제어하고 정상조직의 과가열을 억제할 수 있다.
표적조직의 파괴가 요구된 단계에서 수행된 후에, 다음과 같은 두가지를 임의로 수행할 수 있다. 스타일레트 전극을 카테테르를 회수하여 요도구 부위를 신속하게 치유하고 밀봉할 수 있다. 또한 의사가 제거된 표적조직내에 축적되는 유체 또는 파편을 요도로 배수기키기는 임시적인 생리적 배수관을 만들 수 있다. 이러한 물리적 배수관은 표적 조직 파괴 후에, 제9도에 도시된 바와 같이 요도 카테테르로 절연 슬리브 또는 덮개를 뒤로 당김으로써 표적 조직의 파괴후에 만들어 질 수 있다. 전도성 스타일레트는 조직을 통해 작은 출구를 그을리거나 소작시키기에 충분한 수준으로 에너지를 공급받는다. 이러한 체널은 결국 반흔을 형성시키고, 섬유화되거나 밀봉 및 치유된다. 전도성 스타일레트가 전체적으로 회수되고, 카테테르가 서서히 조심스럽게 요도로부터 회수된다. 환자는 전달된 마취제의 유형 및 환자의 조건에 대해 적합하게 모니터 및 치료된다.
제10도는 전원 및 제어 시스템(150), 수동 카테테르 제어 유니트(152), 카테테르(154) 및 전력푸트 제어부(156)의 어셈블리의 개략적인 도면이다. 전력푸트 제어부 기능은 카테테르 핸들(152)상의 트리거 장치 및 제어박스(150)상의 수동 디지탈 스위치를 포함하는 무수한 다른 방법에 의해 수행될 수 있다. 카테테르 어셈블리의 수동조작이 제11도에 더 상세히 도시된 수동제어 유니트로부터 제어되며, 전력제어 및 온도 디스플레이가 제12도에 상세히 도시된 제어 시스템(150)에 공급된다.
제12도는 본 발명에 따른 시스템의 수동제어 시스템의 구체예를 나타낸 도면이다. 수동제어(152)는 제13도에 도시된 콘솔로 유도하는 튜브(160)이 있는 피스톨 그리퍼(158)을 갖는다. 튜브(160)는 RF 또는 전력공급 케이블, 온도센서, 초음파 변환기 및 신호전달 유도부, 기구팽창 유체 및 진공루멘을 하우징한다.
잠금 스위치(162 및 164)는 기구(30 및 32)의 팽창 또는 수축을 조절한다(제1도 및 제2도). 탭(166)이 앞쪽으로 이동될때 표적 조직으로 탭을 진행시키면서 그루우브(168)내에 미끄러지는 탭(166)이 스타일레트(62)에 연결된다. 회전 다이얼(170)이 카테테르(154)로 접근하고, 스타일레트 또는 스타일레트들의 배향을 위해서 카테테르를 회전시키는데 사용될 수 있다. 원도우(172)는 눈금이 있어서 기구의 팽창율을 나타낸다.
제12도는 본 발명에 따른 시스템의 전원 및 콘솔(150)의 구체예를 나타내는 도면이다. 이러한 콘솔의 하우징은 예컨대, 스타일레트에 대한 전력, 안테나 온도, 조직온도, 임피던스값 및 다른 데이타를 나타내는 디지탈 해독 디스플레이가 있는 디스플레이 패널(174)를 갖는다. 하우징은 시스템 제어버튼(179)을 가지는 밀봉된 막 스위치 패널(178)을 지지할 수 있다. 전력코드(180)이 표준전력 출력으로 유도된다. 케이블(182)이 제11도에 도시된 수동 카테테르 제어 유니트(152)을 유도한다. 케이블(184)가 선택적인 전력푸트 제어 유니트를 유도한다. 케이블(185)는 단극 시스템에 사용되기 위한 접지 패치를 유도한다.
제13도는 본 발명에 따른 장치의 다른 네 개의 프로브 구체예를 나타내는 도면이다. 장치는 핸들부분(182) 및 카테테르 부분(182)을 포함한다. 카테테르 부분(180)은 원위 카테테르 프로브 단부(186)을 가지는 기다른 카테테르(184)를 포함한다. 다수의 스타일레트(188)이 프로브 단부(186)으로 부터 바깥쪽으로 연장되어 있다. 핸들부분(180) 단부(190)가 카테테르(182)의 근위부와 카테테르상에 장착된 수동 제어탭(192 및 194)에 핸들부분의 측벽과의 미끄러지는 결합으로 결합되어 있다. 제어를 위해 핸들(180)을 사용하여, 카테테르가, 예컨대, 요도와 같은 체관, 도관구조 또는 요도관으로 도입되며, 예컨대, 전립선에 인접한 위치의 처리위치로 도관을 밀어 넣는다. 스타일레트(188)는 개별적이고 선택적으로 각각의 수동제어 탭쌍(192 및 194)의 이동에 의해 치료되는 표적 조직으로 주변조직을 통해 원위 단부(190)로 부터 바깥쪽으로 통과된다. 스타일레트는 이동 가능한 슬리브에 의해 둘러싸인 전도체일 때, 슬리브는 이해에서 보다 상세히 기재되는 바와 같이 수동 제어탭(194)의 이동에 의해 스타일레트의 단부로부터 당겨질 수 있다. 바람직하게는, 카테테르(182)의 근위 부분이 체관내에 삽입되는 동안, 제어를 용이하게 하도록 경직되는 것이 바람직하며, 원위 부분은 카테테르가 굴곡된 도관 부분을 통과하도록 가요성인 것이 바람직하다.
제14도는 제13도에 도시된 카테테르의 원위 프로브 단부와 측면 출구로부터 연장되는 스타일레트의 부분적인 단면도이고, 제15도는 선 15-15를 따라 제14도에 도시된 장치의 프로브 단부의 단면 단부도이다. 원위 카테테르 팁(186)은 첨형 팁 부분(198)과 결합되는 외측면(196)을 갖는 스타일레트 가이드 하우징이다. 스타일레트(188)은 외측면(196)으로 부터 바깥쪽으로 연장되어 있으며 전극(200) 및 주위의 이동 가능한 슬리이브(202)를 포함한다. 스타일레트 가이드(214)의 근의부(204)는 카테테르 스템(208)의 원위 단부(206)에 연결되어 있다. 스타일레트(203)가 연장되는 출구와 같은 추가의 스타일레트 출구는 출구(216) 보다 팁(198)로부터 더 먼 거리에 위치된다. 제14도 및 제15도에 도시된 구체예는 카테테르 중심축에 수직을 이루는 공통 평면중에 출구로 부터 연장된 각각의 쌍인 2세트의 스타일레트를 포함한다. 세로 배열 또는 나선 배열과 같은 다른 스타일레트 베열이 또한 사용될 수 있음을 당 기술분야에 숙련자라면 인지할 수 있을 것이며, 이러한 변형은 본 발명의 사상내에 있을 것이다.
카테테르 스템(208)은 평행관계로 배치된 대부분의 스타일레트 스템(212)을 둘러싸고 있는 외부 튜브식 하우징(210)을 포함한다. 제15도에서 볼 수 있듯이, 각각의 스타일레트는 서로간에 각도를 형성하는 축들을 갖는 경로로 바깥쪽을 향하게 되어 있다. 반대쪽으로 배치된 스타일레트는 180°까지의 각도를 형성할 수 있는 반면에, 도시된 형태에 의하면, 근접한 스타일레트의 축은 예컨대90°까지의 각도를 형성할 수 있다.
제16도는 제15도에 16-16를 따른, 본 발명 장치의 프로브 단부의 부분단면도이다. 스타일레트는 다른 스타일레트 가이드와 평행한 스타일레트 가이드(214)의 근위 단부(204)주에 경로로부터 유도된 원위 카테테르 단부(186)중의 스타일레트 가이드 수단(214)을 통해서 스타일레트 출구(216)를 통해 외측으로 유도된다. 가이트 경로를 통해 스타일레트의 세로 이동을 용이하게 하기 위해서는, 바람직하기로 가이드 경로는 출구(216)까지 연장되는 굴곡된 부분(218)을 갖게한다. 선택적으로 굽은 경로는 원하는 각도로 연장되어 배치된 스타일레트를 편향시키기에 충분한 반경, 즉, 카테테르의 직경에 따라 0.5㎝까지의 반경을 갖는다. 또한 특히 바람직하기로, 가이드 경로는 출구(216)에서부터 굽은 경로(218)의 시점까지 바깥쪽으로 떨어진 근위단부(204)중의 축방향으로 평행한 경로로 부터 연장된 역으로 굴곡된 부분(220)을 갖는다.
카테테르 원위 팁(198)은 제1도에 도시된 바와 같이 직장 프로브에 의해 생성된 초음파로 용이하게 확인될 수 있는, 초음파를 반사하는 중공공간 또는 버블(222)을 가질 수 있다. 또한, 응답기는 원위 팁(198)중에 배치 시킬 수 있다.
제17도는 중앙 축을 따라 취한 제13도에 도시된 장치의 핸들 및 제어말단의 단면도이다. 제어핸들(180)은 카테테르 스템(208)의 제어말단에 연결된다. 이 핸들(180)은 카테테르 스템(208)의 근위 말단(226)을 둘러싸고 있는 축 슬리브(224)를 형성하는 원위 말단을 갖는 하우징을 포함한다. 근위 말단(226)은 슬리브(224)를 통해서 연장된 세트스크루(228)에 의해 적절히 유지되어 있다. 수동 맞물림 수단(192 및 194)은 외측 핸들 하우징 벽들(230 및 232)와 맞물리고, 하우징 벽중에 각각의 슬롯(234 및 236)과 미끄럼 맞물림으로 설치되어 있다. 이러한 연결은 스타일레트 가이드 수단에서의 스타일레트의 수동운동을 세로운동으로 전환시킨다.
제18도는 제17도의 선 18-18을 따라 취한, 제13도에 도시돈 장치의 제어말단의 횡단면도이다. 제17도 및 제18도를 참조하면, 핑거 인게이징 슬리브 이동탭(192)은 핸들 벽(230)의 내부표면과 미끄럼 맞물림을 형성하는 안쪽부분(240) 및 각각의 세로 슬롯(234)을 통해 연장된 연결 슬라이드 부분(238)과 연결된다. 연결 슬라이드 부분중의 슬롯(242)은 슬리브 접속기(246)을 통해 연장된 핀(244)을 수용한다. 따라서, 탭(192)의 축방향 이동은 핸들중에서의 상응하는 슬리브(248)의 축 이동에 영향을 미친다. 핸들의 각각의 측면은 한쌍의 세로, 평행 슬롯을 가지며 슬리브와 전도체 둘다에 대한 수동 탭을 수용한다.
제19도는 제18도의 선 19-19를 따라 취한, 제13도에 도시된 장치의 제어 말단의 단면도이다. 제17도 및 제19도를 참조로 하면, 핑거 인게이징 전도체 이동 탭(194)은 각각의 세로 슬롯(236)을 통해서 핸들 벽(232)의 내부면과 미끄럼 맞물림을 형성하는 안쪽 부분(252)까지 연장된 연결 슬라이드 부분(250)을 통해서 연결된다. 슬롯(254)은 전도체 접속기(258)를 통해 연장된 핀(256)을 받아들인다. 따라서, 탭(194)의 축 이동은 핸들중의 상응하는 전도체(260)의 축이동에 영향을 미친다.
인접한 탭(192 및 194)은 상응하는 슬리브 및 전도체와 함께 상응하는 스타일레트 가이드를 통해서 상응하는 스타일레트 출구 밖으로 이동하고, 조직 사이를 통과해서 제거될 표적 조직까지 이동한다. 슬리브 탭(192)의 이동은 슬리브를 뒤로 끌어 당겨서, 조직중에 있는 전도체 표면을 소정의 부위에 노출시킨다.
제20도는 제17도 및 제18도에 도시된 구체예의 비전도성 슬리브 접속기의 측면도이고, 제21도는 선 21-21을 따라 취한, 제20도에 도시된 비전도성 슬리브 접속기의 단면도이다. 연결 핀(244)은 슬리브 접속기(246)중의 출구를 통해 연장된다. 슬리브 접속기(246)의 축방향 에지는 슬리브의 근위 말단 부분(248)에 연결된다.
제22도는 제17도 및 제19도에 도시된 구체예의 전도체 접속기의 측면도이고, 제24도는 선 23-23을 따라 취한, 제22도에 도시된 전도체 접속기의 단면도이다. 연결 핀(256)은 전도체 접속기(258)중의 출구를 통해 연장된다. 전도체 접속기(258)의 축방향 에지는 전도체의 근위 말단 부분(260)에 연결된다.
제24도는 제15도 내지 제17도의 중앙 축을 따라 취한, 제15도 내지 제17도에 도시된 비전도성 슬리부의 원위 말단의 단면도이다. 비전도성 슬리브(202)는 첨형 유도 팁(262) 및 경질 근위 부분(264)를 포함한다. 가요성 부분(266)은 유도 팁(262) 사이에서 경질 근위 부분(264)으로 연장된다. 이 가요성 부분(266)은 요구된 가요성 및 토오크 강도를 갖는 카테테르를 형성시키는 어떠한 가요성 구성물, 예컨대 나선형 코일, 와이어 편조, 스테인레스 강철 튜브, 또는 어떠한 다른 가요성 구조물일 수 있다, 만약 가요성 부분(266) 및 경질 근위 부분(264)이 금속과 같은 전도성 물질로 이루어진다면, 이것들은 절연성 슬리브(268)로 피복될 수 있다. 경질 근위 부분중의 환형에지(27) 및 팁중의 플랜지(272)는 슬리브(268)와 맞물려 있어서, 슬리브를 적소에 고정시킨다. 비전도성 슬리브(202)의 안쪽 루멘(274)은 전기 접속기(200)를 수용한다. 서미스터(271)와 같은 온도 감지기는 팁상에 설치되어 국부 온도 정보를 제공할 수 있다. 또한 초음파 응답기(273)가 팁상에 설치되어 제거될 조직중의 스타일레트 팁의 위치를 결정하는데 유용한 신호를 제공할 수 있다.
제25도는 본 발명의 RF 제거 카테테르의 2가지 스타일레트의 바람직한 구체예의 정면도이다. 핸들(32)에 연결된 가요성 카테테르(300)는 말단 스타일레트 가이드(304)와 2 스타일레트(306 및 308)을 갖는다. 이 핸들은 하기에서 보다 상세히 설명되는 바와 같이, 스타일레트 슬리브 탭(356)과 전극 탭(358)을 갖는다. 또한 핸들은 시각적 모니터(301) 및 RF 전력 접속기(303),응답 접속기(305) 및 열전기쌍 접속기(307)에 연결된다. 핸들(302)로부터 스타이레트 가이드 팁(304)까지 인도된 카테테르(300)의 일부분은 선택적으로 등금화된 강도를 가질 수 있다. 예를들면, 카테테르는 핸들 근처에서 좀 더 강하게 설계되고, 팁 근처에서 좀 더 유연하게 설계되거나, 어떠한 다른 강도 프로필로 설계될 수 있다. 카테테르는 미국특허 제5,322,064호에 기재된 바와 같이 외부의 가요성 슬리브와 안족에 슬롯된 스테인레스 강철 튜브로 구성될 수 있다. 본원에서는 상기 특허원을 참조로 인용한다. 또한, 카테테르는 외부 슬리브로 둘러싸인 코일형 와이어 또는 편조된 와이어로 형성될 수 있다.
제26도는 제25도에 도시된 구체예의 스타일레트 팁의 정면도이고, 제27도는 제26도에 도시된 단일 연마 전극 팁의 측면도이다. 제28도는 제27도에 도시된 전극 팁의 단부도이다. 상기 구체예에 있어서, 날카로운 팁(326) 및 유도 절단 에지(328 및 330)는 팁의 하나의 표면을 연마시킴으로써 형성되며, 이러한 절단 에지는 팁의 중앙축과 평행한 선과 15° 내지 35°의 각도, “d”를 이루고 있다. 팁의 근위 표면은 슬리브(336)의 유도 또는 원위 에지(334)가 인접하는 쇼올더(332)를 형성하여, 날카로운 팁을 넘어서 슬리브(336)가 이동하는 것을 억제한다. 또한 슬리브(336)는 더어미스터(338) 및 초음파 응답기(340)와 같은 온도 감지기를 지지할 수도 있다.
제29도는 또 다른 이중 연마 전극 팁의 측면도이고, 제30도는 제29도에 도시된 전극 팁의 단부도이다. 상기 구체예에 있어서, 날카로운 팁(342) 및 유도 절단 에지(344 및 346)는 팁의 양쪽 표면을 연마시킴으로써 형성된다. 팁의 근위부 표면은 슬리브의 유도 또는 원위 에지(도시되지 않음)가 인접하여 날카로운 팁을 넘어서 슬리브가 이동하는 것을 억제하는 쇼울더(348)를 형성한다. 상기 구체예의 근위 절단 에지는 카테테르 팁중에 스타일레트 가이드의 내부 표면과의 어떠한 접촉이 있다면 절단 에지의 무디어짐을 거의 방지하지 못한다.
제31도는 제25도의 제거 카테테르의 핸들부분의 정면도이다. 핸들(302)은 상부 하우징 플레이트(350)를 가지며, 이러한 플레이트상에 슬라이드(352)를 위치시키는 스타일레트 슬리브 및 슬라이드(354)를 위치시키는 전극과 수동의 탭들(356 및 358)이 설치되어, 하우징의 중앙축의 방향으로 미끄러짐 이동을 한다. 하우징 플레이트 표면상에 눈금표시(362)와 관련된 슬라이드의 유도 에지(360)의 위치는 슬리브의 거리를 측정하는데 이용되며, 스타일레트가 스타일레트 가이드로부터 치료되는 조직을 향해 이동한다.
제32도는 바닥 하우징 커버 플레이트가 부분적으로 제거되고 선 32-32를 따라 취한 제31도에 도시돈 핸들부분의 측면도이다. 카테테르(300)의 근위 말단은 상부 하우징 플레이트(350)와 하부 하우징 플레이트(370)의 원위 말단에서 마주보는 반원통형 표면에 의해 형성된 원통형 널리드 노브(366)와 원통형 수용체(368)내의 원통형 출구(364)을 통과한다. 널리드 노브(366)의 근위 말단은 하우징 플레이트(350 및 370)의 원위 말단에 의해 형성되는 원통형 수용체(372)를 지닌 슬라이딩 피트를 형성하는 원통형 수용체(372)를 갖는다. 세트 스크류(376)는 노브(366)를 카테테르(300)에 고정시켜, 하나의 유닛으로 회전한다. 핀(378)은 노브(366)를 통해서 환형 그루브(380)내로 연장되어, 노브(366)의 회전은 가능하게 하지만, 실린더(374)로의 축방향 이동은 억제한다. 하우징 플레이트(350)에 대한 노브(366)의 각도상의 위치는 노브의 눈금(384)에 대한 화살표(382)의 위치로 나타난다(제31도). 널리드 노브(386)은 하우징 플레이트(350)중의 출구(388)에 나사선에 의해 맞물린다. 카테테르 노브(366)가 카테테르(300)(및 카테테르 말단상의 스타일레트 가이드)를 원하는 스타일레트 배향으로 회전시키기 위해 돌려질 때, 카테테르 표면(390)에 대한 노브(386)의 진행은 이것의 각도위치를 고정한다. 이어서, 스타일레트는 눈금(362)으로 표시된 바와 같은 주위 조직을 통과해서 원하는 깊이로 진행된다.
제33도는 카테테르, 원위 노브 및 바닥 커버 플레이트를 제거한 제31도에 도시된 핸들 부분의 저면도이고, 제34도는 제33도의 선 선 34-34를 따라 취한 핸들부분의 단면도이다. 스타일레트 이동 가이드 플레이트(392 및 394)는 상부 하우징 플레이트(350)의 내부 표면중의 종말 단부 수용체(396)에 안전하게 설치된다. 각각의 가이드 플레이트(392 및 394)는 슬리브 가이드 슬롯(398) 및 전극 가이드 슬롯(400)을 내재하고 있다. 스크류(402)는 슬리브 가이드 슬롯(400)을 통해 연장되어 슬리브 가이드 블록(404)에 나사선에 의해 맞물린다. 스크류(402) 및 이에 부착된 가이드블록(404)의 축방향 이동은 슬롯(398)의 길이에 의해 제한된다. 스타일레트 슬리브(408)에 결합된 슬리브 접속기(406)는 스크루(410)에 의해 가이드 블록(404)에 고정된다. 하우징 플레이트(350) 중의 슬롯(414)내에서 미끄러움 이동을 하게 설치된 슬라이드 플레이트(352)는 가이드 블록(404)에 고정된다. 스크루(416)는 슬리브 가이드 슬롯(400)을 통해 연장되어, 전극 가이드 블록(418)에 나사선에 의해 맞물린다. 스크루(416) 및 이에 결합된 가이드 블록(418)의 축방향 이동은 슬롯(400)의 길이에 의해 제한된다. 스타일레트 전극(422)에 부착된 전극 접속기(420)은 스크루(424)에 의해 가이드 블록(418)에 고정된다. 하우징 플레이트(350)중의 슬롯(426)내에서 미끄러움 이동을 하도록 설치된 슬라이드 플레이트(354)는 가이드 블록(418)에 고정된다.
제35도는 스타일레트 및 슬리브 끌어당김 위치(제31도중의 위치에 상응)에서의 제32도에 도시된 핸들부분의 중앙부분의 단면도이다. 제36도는 연장된 위치에서의 스타일레트 및 슬리브의 단면도이고, 제37도는 연장된 위치에서의 스타일레트 및 슬리브의 단면도이다. 카테테르가 삽입되어 스타일레트 가이드가 치료되는 표적조직의 측면에 인접한 위치에 배치되고, 카테테르가 회전하여 스타일레트 가이드 출구를 표적조직 방향으로 배향된 후에, 스타일레트가 연장된다. 스타일레트는 제36도에 도시된 것처럼 수동탭(356 및 358)을 핸들의 원위 말단 쪽으로 이동시킴으로써 중간의 조직을 통과해서 표적조직으로 연장된다. 이러한 과정은 스타일레트 슬리브(408) 및 전극(422)의 동시 이동으로 수행된다. 표적조직중에 전극(422)의 팁을 배치시키는데 요구되는 곳까지 연장시킨 후에, 눈금(362)에 의해 표시되는 바와 같이 전극의 바람직한 부분을 노출시키는데 요구된 길이로 근위 방향으로 수동 탭(358)을 이동시킴으로써 제37도에 도시된 위치로 슬리브(408)을 끌어당겨진다(제31도). 이어서 원하는 만큼 제거가 이루어질 때까지 RF 전류를 전극에 흐르게 한다. 상기의 구체예에 있어서, 2 가지 스타일레트를 연장시키고, 슬리브를 끌어당겨서, 제거를 동시에 또는 연속적으로 수행시킬 수 있다.
제38도는 본 발명에 따른 방법에 의한 절제 영역을 중첩시키는 스타일레트 배향을 나타내는 전립선에서의 2 스타일레트의 개략적인 배치도이다. 본 발명을 제한하는 것이 아니라 단지 설명하기 위해서, 본 발명의 설명에 전립선을 선택했으며, 신체의 그밖의 부위에 대한 본 발명의 방법 및 어셈블리의 적용도 본 발명에 포함되는 것이다.
BPH의 처리로 치료되는 조직은 전립선의 전이영역(428)중에 위치된다. 본 발명의 카테테르(430)는 요도(432)위로 전립선에 근접한 위치에 삽입된다. 2개의 스타일레트(434 및 436)은 요도벽(432)과 주위 조직을 통과하고, 비전도성 슬리브(438 및 440)가 끌어당겨져서 스타일레트 말단에서의 각각의 전도체(442 및 444)의 일부를 노출시킨다. 본 구체예에서의 스타일레트의 축들 사이의 각도 “e”는 180°미만, 바람직하게는 110°도 미만이다. 대부분의 중첩 제거에 있어서, 15° 내지 90°, 더욱 일반적으로 20° 내지 70°의 각도가 가장 실제적이다. 접지 플레이트(도시되지 않음)는 신체 외부에 배치시킨다.
전극(442 및 444)에 RF 전류가 공급될 때, 전극으로부터 접지 플레이트까지의 회로가 접속된다. 조직을 통해 흐르는 전류밀도는 치료되는 표적조직을 통과하여, 대체적인 횡단면 형태의 중첩영역(446 및 448)를 갖는 손상부를 형성시킨다. 전류밀도는 거리의 함수로서 신속하게 감소하여, 손상부의 크기를 제한한다. 이러한 방법으로, 손상부가 중첩되어 보다 큰 손상부를 형성시켜서, 치료효과를 증가시킨다. 이러한 과정이 상기된 바와 같이 동시에 또는 연속적으로 수행될 수 있으며, 이러한 변형도 본 발명에 포함되는 것이라는 것이 용이하게 인지될 수 있을 것이다.
본 발명의 바람직한 구체예가 약간 상세히 설명되고 있지만, 이러한 설명으로부터 명백하게 알 수 있는 변형된 형태가 청구범위에 의해 정의된 바와 같은 본 발명의 사상 및 범위를 벗어나지 않으면서 가능하다는 것을 이해할 수 있을 것이다.

Claims (13)

  1. 방광의 기저부 근처에서 요도를 둘러싸고 있는 전립선 조직의 세로축을 따라 방광의 기저부로 연장되는 요도벽에 의해 형성된 요도가 있는 페니스와 기저부가 있는 방광을 지닌 남성의 전립선 조직중의 표적량을 고주파 절제 처리하는 의료장치로서, 근위 및 원위 말단을 지니며, 세로축이 있고, 요도로 유입될 수 있고, 원위 말단이 전립선의 인접부위에 위치되는 경우에 근위 말단이 요도의 외부에 위치되도록 하는 걸이로 형성되어 있으며, 근위 말단으로부터 원위 말단으로 연장되는 경로를 지니는 기다란 프로브 부재, 기다란 프로브 부재의 경로내에 미끄러지는 방식으로 우치되며 예리한 팁이 있는 고주파 전도성 전극을 포함하는 스타일레트, 기다란 프로브 부재의 근위 말단에 결합된 핸들, 핸들에 의해 결합되어 있고 기다란 프로브 부재의 경로내에서 스타일레트가 이동되도록 하는 작동수단, 및 스타일레트에 연결된 반송경로를 포함하여 스타일레트에 고주파 에너지를 공급하는 고주파 에너지 공급수단을 포함하며, 상기 스타일레트는 예리한 팁이 있는 고주파 전도성 전극과 이러한 고주파 전도성 전극상에 동축으로 설치되는 절연물질층을 포함하고, 상기 절연물질층은 고주파 전도성 전극의 원위부분이 절연되지 않고 전립선의 조직에 노출되어, 고주파 에너지가 고주파 전도성 전극에 공급될 때, 표적량의 전립선 조직을 절제하도록 하는 형태로 형성되며, 요도벽을 통해서 연장되고, 고주파 전도성 전극에 공급된 고주파 에너지로부터 요도벽을 보호하도록 형성되는 의료장치.
  2. 제1항에 있어서, 절연물질층과 고주파 전도성 전극이 서로 미끄러지는 방식으로 이돌할 수 있으며, 힌드이 고주파 전도성 전극과 절연물질층 사이에 상대적 이동을 유발시키는 고주파 js도성 전극과 절연물질층에 고정된 수단을 포함함을 특징으로 하는 의료장치.
  3. 제1항에 있어서, 고주파 저도성 전극이 그를 통해 연장되는 축방향 루멘을 지녀 액체를 전립선 조직에 전달함을 특징으로 하는 의료장치.
  4. 제1항에 있어서, 기다란 프로브 부재의 경로내에 미끄러지는 방식으로 추가의 스타일레트가 위치되고, 작동수단이 핸들에 의해 연결되고 추가의 스타일레트에 연결되어 기다란 프로브 부재의 경로내에서 추가의 스타일레트가 이동할 수 있게 하며, 상기 추가의 스타일레트는 예리한 팁을 지닌 고주파 전도성 전극과 고주파 전도성 전극상에 동축으로 위치된 절연물질층을 포함하며, 상기 절연물질층은 추가 스타일레트의 고주파 전도성 전극의 원위부분이 절연되지 않고 전립선의 조직에 노출되어, 고주파 에너지가 추가 고주파 전도성 전극에 공급될 때, 표적량의 전립선 조직을 절제하도록 하는 형태로 고주파 전도성 전극상에 동축으로 위치되고, 요도벽을 통해서 연장되며, 추가 스타일레트의 고주파 전도성 전극에 공급된 고주파 에너지로부터 요도벽을 보호함을 특징으로 하는 의료장치.
  5. 제4항에 있어서, 고주파 전도성 전극이 서로 예각으로 표적량의 전립선내로 연장됨을 특징으로 하는 의료장치.
  6. 제4항에 있어서, 반송 경로를 포함하는 수단이 전립선 조직을 통해 제2고주파 전도성 전극으로 통과하도록 고주파 에너지를 제1고주파 전도성 전극에 공급하여, 고주파 전도성 전극들 사이에 위치된 조직을 절제함을 특징으로 하는 의료장치.
  7. 제1항에 있어서, 절연물질상에 설치되어 절제가 수행되는 동안의 전립선 조직의 온도를 측정하는 온도 측정 수단을 추가로 포함함을 특징으로 하는 의료장치.
  8. 제1항에 있어서, 전립선 조직의 임피던스를 측정하는 수단을 추가로 포함함을 특징으로 하는 의료장치.
  9. 제1항에 있어서, 절연물질층이 고주파 전도성 전극의 예리한 선단을 향하여 내부로 및 원위부로 테이퍼링되는 원위말단을 지님을 특징으로 하는 의료장치.
  10. 제1항에 있어서, 고주파 전도성 전극이 전도성 물질만으로 구성됨을 특징으로 하는 의료장치.
  11. 제1항에 있어서, 고주파 전도성 전극이 니켈-티탄 합금으로 구성됨을 특징으로 하는 의료장치.
  12. 제1항에 있어서, 기다란 프로브 부재에 연결되어 있으며, 기다란 프로브 부재의 통로와 조합식으로 결합되어, 스타일레트가 세로축에 일정한 각으로 연장되도록 굴곡되는 경로를 통해 이동하게 하는 수단을 추가로 포함함을 특징으로 하는 의료장치.
  13. 제1항에 있어서, 반송 경로를 포함하는 수단이 남성의 신체와 접촉되는 접지판을 포함함을 특징으로 하는 의료장치.
KR1019950700585A 1992-08-12 1993-08-11 의료용 탐침장치 및 방법 KR100273015B1 (ko)

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US6610054B1 (en) 2003-08-26
US5599294A (en) 1997-02-04
ATE132046T1 (de) 1996-01-15
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US5964727A (en) 1999-10-12
TW234695B (ko) 1994-11-21
GB9303060D0 (en) 1993-03-31
GB2269538B (en) 1996-10-09
IN182704B (ko) 1999-06-26
CA2226484C (en) 2000-12-12
GB2269538A (en) 1994-02-16
FR2694700A1 (fr) 1994-02-18
US6852091B2 (en) 2005-02-08
US6129726A (en) 2000-10-10
DE4305663A1 (de) 1994-02-17
EP0611314A1 (en) 1994-08-24
MX9304905A (es) 1994-04-29
US5531676A (en) 1996-07-02
US20020183740A1 (en) 2002-12-05
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EP0893101B1 (en) 2004-04-07
US5800378A (en) 1998-09-01
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FI950584A (fi) 1995-04-04
AU4999893A (en) 1994-03-15
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US5536240A (en) 1996-07-16
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EP0611314A4 (en) 1994-09-14
IL104647A (en) 1995-12-31
EP0893101A2 (en) 1999-01-27
KR950702848A (ko) 1995-08-23
ES2084510T3 (es) 1996-05-01
US6419653B2 (en) 2002-07-16
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WO1994004220A1 (en) 1994-03-03
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US7387626B2 (en) 2008-06-17
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US5366490A (en) 1994-11-22
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US20010031941A1 (en) 2001-10-18
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US6814712B1 (en) 2004-11-09
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