KR20110104504A - 조직 토폴로지의 지식 여하에 따른 에너지의 선택적 축적 - Google Patents

조직 토폴로지의 지식 여하에 따른 에너지의 선택적 축적 Download PDF

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KR20110104504A
KR20110104504A KR1020117014112A KR20117014112A KR20110104504A KR 20110104504 A KR20110104504 A KR 20110104504A KR 1020117014112 A KR1020117014112 A KR 1020117014112A KR 20117014112 A KR20117014112 A KR 20117014112A KR 20110104504 A KR20110104504 A KR 20110104504A
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tissue
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energy
pulsed
heat
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롤프 타이슨 거스터스
리나스 쿤스트마나스
아써 지. 블랑크
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미노우 메디컬, 인코포레이티드
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Abstract

조직 토폴로지의 지식 여하에 따른 동맥 조직 내에서의 에너지의 선택적 축적을 사용하여, 병든 부분과 건강한 부분을 포함하는 신체 내강에 인접한 신체 조직 영역을 가열하는 방법 및 시스템이 제공된다. 상기 방법은, 가열되어야 할 신체 조직 영역에 인접한 내강 내에 카테터 본체의 에너지 전달부를 위치시키는 단계, 상기 제1 조직 타입의 열 속성에 따라 펄스 특성을 결정하는 단계, 및 상기 제1 조직 타입에 대한 현저한 열 손상을 방지하는 속도로 상기 제2 조직 타입에서 열을 증가시키면서 상기 제1 조직 타입으로부터 열이 방출되게 함으로써, 상기 신체 조직 영역 내의 상기 제2 조직 타입을 치료적으로 처치하도록 상기 에너지 전달부로부터 상기 펄스 특성을 갖는 펄스형 에너지를 인가하는 단계를 포함한다.

Description

조직 토폴로지의 지식 여하에 따른 에너지의 선택적 축적{SELECTIVE ACCUMULATION OF ENERGY WITH OR WITHOUT KNOWLEDGE OF TISSUE TOPOGRAPHY}
관련 출원에 대한 상호 참조
본 특허 출원은, 미국 특허법 35USC 119(e)에 의거, 2008.11.17. 출원된 미국 임시 출원 제61/115,344호의 개시 내용 전체를 상호 참조에 의하여 본 발명의 일부로 한다.
본 특허 출원은, 2007.10.18. 출원된 미국 특허 출원 제11/975,474호(Inducing Desirable Temperature Effects on Body Tissue), 2007.10.18. 출원된 미국 특허 출원 제11/975,383호(System for Inducing Desirable Temperature Effects on Body Tissues), 2005.5.3. 출원된 미국 특허 출원 제11/122,263호(Imaging and Eccentric Atherosclerotic Material Laser remodeling and/or Ablation Catheter) 및 2008.9.22. 출원된 미국 임시 출원 제61/099,155호(Inducing Desirable Temperature Effects On Body Tissue Using Alternate Energy Sources)에 관한 것으로서, 이들 모두의 개시 내용 전체를 상호 참조에 의하여 본 발명의 일부로 한다.
연방 정부의 지원에 의한 연구 및 개발 과제로부터
창출된 발명에 관한 권리의 주장
해당 사항 없음.
본 발명은 신체 조직을 가열하기 위한 의료 장치, 시스템 및 방법에 관한 것이다. 예시적인 실시예에 있어서, 본 발명은, 조직 토폴로지(tissue topology)에 관한 연역적 지식의 유무 여하에 따라, 바람직한 타입의 조직, 특히 병든 조직(diseased tissue)에 선택적으로 축적되는 에너지로 신체 조직을 가열하는 카테터 기반 처치(catheter-based treatment)를 제공한다.
풍선 혈관 성형술(balloon angioplasty) 및 기타 카테터들은 종종 동맥경화증에 의해 좁아진 동맥을 개방하는데 사용된다. 풍선의 확장에 수반되는 손상(trauma)은 심각한 부상을 입힐 수 있으며, 그로 인해 때때로 풍선 확장의 장점이 제한되기도 한다. 스텐트(stent)도 혈관의 개방으로 인한 이점을 더욱 확대하기 위하여 널리 사용되고 있다. 스텐트 처치 이후에 신체 내강(body lumen)의 재협착(restenosis)이나 후속적인 좁아짐 등이 상당수 발생하고 있다.
최근에, 약물로 코팅된 스텐트(drug coated stent)(예를 들어, 존슨앤존슨사의 싸이퍼(Cypher; 등록상표) 스텐트와 서로리무스(Sirolimus; 등록 상표)를 함유한 부속 약물)가 현저히 감소된 재협착율을 보여주었으며, 다른 대안 약물 용출성 스텐트(drug-eluting stent)도 개발 중이거나 상용화중에 있다. 또한, 절차적인 혈관 성형술의 성공률을 향상시킬 수 있는 체계적 약물 전달(정맥 주사 또는 구강 투여)을 위한 연구도 개시되었다.
다수의 환자에 있어서 약물 용출성 스텐트가 동맥 경화증의 처치에 상당한 희망을 가져다준 것으로 보이긴 하지만, 스텐트가 채용될 수 없거나 현저한 부작용을 가져오는 사례도 여전히 많이 남아있다. 일반적으로, 스텐트 삽입술은 신체내에 삽입물(implant)을 남긴다. 이러한 삽입물은 기계적인 피로(fatigue), 부식(corrosion) 등과 함께 특히 삽입물을 제거하기가 어렵고 이를 제거하기 위하여는 외과적 수술이 필요하다는 점 등을 포함하는 위험이 상존함을 의미한다. 스텐팅 삽입술은 확산성(미만성) 동맥 질환(diffuse artery disease)의 처치, 분지(bifurcation) 처치, 압궤(壓潰 crush) 손상을 입기 쉬운 신체 영역의 처치, 비틀림, 늘어남, 줄어듬 등에 취약한 동맥의 처치 등에 있어서 추가적인 단점을 갖고 있다.
종종 풍선 혈관 성형술 및/또는 스텐트 삽입술과 조합되는 혈관내 방사선 처치, 저온(cryogenic) 처치, 초음파 에너지 처치 등과 같은 다양한 수정된 재협착 처치 또는 재협착 억제 처치 등의 요법들이 제안되어 있다. 이러한 다양한 접근법들은 혈관 성형술과 스텐트 삽입술 이후의 후속적인 혈류의 퇴행을 저하시키는 다양한 수준의 가능성을 보여주지만, 혈관 성형술에 의하여 애초에 조직에 입힌 손상은 여전히 문제로 남는다.
스텐트 삽입술 및 풍선 혈관 성형술에 대하여, 협착된 동맥을 개방하기 위한 다수의 대안이 또한 제안되어 있다. 예를 들어, 상당히 다양한 아테렉토미(atherectomy;절제술) 장비들과 기법들이 제안되었고 시도되었다. 혈관 성형술과 스텐트 삽입술의 단점이나 한계에도 불구하고, 아테렉토미는 확장 기반 접근법만큼 널리 활용되거나 그에 필적하는 성공률을 얻지 못하고 있다. 최근에는 확장술의 추가적인 단점들이 밝혀졌다. 이들은, 장기를 파열시키거나, 심근 경색 또는 심장 마비를 일으킬 수 있는 물질을 분비할 수 있는 취약한 플라크(plaque)의 존재를 포함한다.
상기한 바에 비추어, 동맥 조직에서 혈관의 확장을 유도하며 신체의 내강을 재형성하기 위한 방법 및 시스템을 제공하는 것이 바람직하다. 또한, 극도의 확장으로 인한 손상을 야기하지 않으면서 신체의 내강을 재형성할 수 있는 구조를 제공하면서도 상당한 비용과 복잡함을 피할 수 있는 것, 그리고 스텐트 삽입술이 적합하지 않은 혈관이나 다른 신체 내강을 개방할 수 있도록 하는 것이 바람직하다.
제1 국면에서, 본 발명의 실시예들은 신체 내강에 인접한 신체 조직 영역을 가열하는 방법을 제공하고, 상기 영역은 제1 조직 타입과 제2 조직 타입을 포함한다. 상기 방법은 가열되어야 할 신체 조직 영역에 인접한 내강 내에 카테터의 에너지 전달부를 위치시키는 단계, 상기 제1 조직 타입의 열 속성에 따라 펄스 특성을 결정하는 단계, 및 상기 제1 조직 타입에 대한 현저한 열 손상을 방지하는 속도로 상기 제2 조직 타입에서 열을 증가시키면서 상기 제1 조직 타입으로부터 열이 방출되게 함으로써, 상기 신체 조직 영역 내의 상기 제2 조직 타입을 치료적으로 처치하기 위하여, 상기 에너지 전달부로부터 상기 펄스 특성을 갖는 펄스형 에너지를 인가하는 단계를 포함한다.
또 다른 국면에서, 본 발명의 실시예들은 신체 내강에 인접한 신체 조직 영역을 가열하는 카테터 시스템을 제공하고, 상기 영역은 제1 조직 타입과 제2 조직 타입을 포함한다. 상기 시스템은, 근위단 및 원위단과 이들 사이의 축을 포함하는 긴 가요성 카테터 본체, 상기 원위단에 근접한 에너지 전달부, 상기 에너지 전달부에 연결된 에너지원, 및 상기 에너지원에 연결된 프로세서를 포함하고, 상기 프로세서는 상기 제1 조직 타입에 대한 현저한 열 손상을 방지하는 속도로 상기 제2 조직 타입에서 열을 증가시키면서 상기 제1 조직 타입으로부터 열이 방충되도록 함으로써 상기 신체 조직 영역 내의 상기 제2 조직 타입을 치료적으로 처치하도록, 상기 에너지원으로부터 상기 에너지 전달부로 전송되는 펄스형 에너지의 펄스 특성을 제어한다.
다수의 실시예에서, 상기 펄스형 에너지는 상기 제1 조직 타입보다 상기 제2 조직 타입을 선택적으로 가열하고, 상기 선택적인 가열은 적어도 부분적으로, 상기 제1 조직 타입의 열 전도보다 더 낮은 열 전도, 상기 제1 조직 타입의 비열용량보다 더 낮은 비열용량, 상기 제1 조직 타입의 선천적 혈액 관류(blood perfusion)보다 더 적은 선천적 혈액 관류, 관류가 양호한 영역들로부터의 거리가 관류가 양호한 영역들과 상기 제1 조직 타입 사이의 거리보다 더 먼 것 중 일부 또는 전부를 포함하는, 상기 제2 조직 타입의 특성 그룹 중 하나 또는 그 이상에 의해 유도된다.
다수의 실시예에서, 상기 그룹의 특성들의 대부분은, 상기 제2 조직 타입에서 열이 증가하도록 하면서 상기 제1 조직 타입에 대한 현저한 열 손상을 방지하는 속도로 상기 제1 조직 타입으로부터 열이 방출되게 한다.
다수의 실시예에서, 상기 펄스형 에너지는 상기 신체 조직 영역에 0.25 내지 5와트(watt)의 평균 속도로 전달된다.
다수의 실시예에서, 상기 펄스형 에너지의 각각의 펄스는 상기 신체 조직 영역에 4 내지 45줄(Joule)을 제공한다.
다수의 실시예에서, 상기 신체 조직 영역에 전달되는 펄스형 에너지의 평균 속도는 상기 제1 조직 타입에 의한 에너지 소실 속도의 실질적으로 0.1배 내지 10.0배이다.
다수의 실시예에서, 펄스들 사이의 기간은 상기 펄스형 에너지에 의한 상기 제1 조직 타입에 대한 열 손상을 방지하기에 적절하도록 상기 제1 조직 타입이 그 열을 소실하게 한다.
다수의 실시예에서, 에너지의 펄스들 사이의 기간은 0.1 내지 180초이다.
다수의 실시예에서, 상기 제1 조직 타입에 대한 열적 시상수(thermal time constant)는 특정 조직의 독립된(discrete) 체적이 지수형 감소를 겪으면서 그 열의 대략 63%를 잃는데 걸리는 시간이다.
다수의 실시예에서, 펄스형 에너지는 제1 조직 타입 시상수의 적어도 몇 배인 지속 시간에 걸쳐 상기 신체 조직 영역으로 전달되고, 상기 제1 조직 타입의 열적 시상수는 상기 제1 조직 타입의 열 전도율에 비례한다.
다수의 실시예에서, 상기 제2 조직 타입의 열 전도율은 상기 제1 조직 타입의 열 전도율의 두 배이다.
다수의 실시예에서, 에너지원은 무선 주파수(RF) 에너지원을 포함한다.
다수의 실시예에서, 상기 에너지 전달부는, 신체 내강에 대향하여 복수의 전극 표면과 결합하는 방사상으로 확장가능한 구조를 포함하고, 상기 신체 내강에 대향하는 상기 복수의 전극 표면은 상기 제1 조직 타입과 상기 제2 조직 타입을 포함하는 복수의 회로를 완성하고, 상기 펄스형 에너지는 상기 복수의 회로로 전달된다.
다수의 실시예에서, 에너지원은 레이저 에너지원을 포함한다.
다수의 실시예에서, 상기 에너지 전달부는, 적어도 하나의 광 도관(optical conduit)에 연결된 적어도 하나의 방사상으로 배열된 윈도우(window)를 포함하고, 상기 광 도관은 신체 조직 영역으로의 펄스형 에너지의 전송을 위해 카테터 본체의 근위단과 적어도 하나의 윈도우 사이에서 연장된다.
다수의 실시예에서, 에너지원은 신체 조직 영역으로 펄스형 초음파 에너지를 전달하기 위한 초음파 전송기를 포함한다.
다수의 실시예에서, 에너지원은 마이크로파 에너지원을 포함하고, 상기 마이크로파 에너지원은 신체 조직 영역으로 펄스형 마이크로파 에너지를 전달하기 위한 적어도 하나의 마이크로파 안테나를 포함한다.
본 발명에 의하면, 동맥 조직에서 혈관의 확장을 유도하며 신체의 내강을 재형성할 수 있다. 또한, 극도의 확장으로 인한 손상을 야기하지 않으면서 신체의 내강을 재형성할 수 있는 구조를 제공하면서도 상당한 비용과 복잡함을 피할 수 있다. 또한, 스텐트 삽입술이 적합하지 않은 혈관이나 다른 신체 내강을 개방할 수 있다.
도 1은 동맥 조직을 가열하기 위한 카테터 시스템의 일 실시예를 개념적으로 도시한 도면이다.
도 2는 도 1에 도시된 카테터 시스템에 사용되는 풍선의 일 실시예를 도시한 도면이다.
도 3은 일정한 열 또는 에너지 펄스 속도로 건강한 조직과 병든 조직을 가열하는 경우의 온도 대 시간 곡선을 도시한 도면이다.
도 4는 다른 속도로 열 또는 에너지를 인가한 경우 건강한 조직과 병든 조직을 모두 갖는 조직의 온도 대 시간 곡선을 도시한 도면이다.
도 5는 온도에 대한 열 소실의 효과를 도시한 도면이다.
도 6은 다리 조직의 쌍극 처치를 위해 사용되는 풍선 카테터 시스템의 일 실시예를 개념적으로 도시한 도면이다.
도 7은 다리 조직의 단극 처치를 위해 사용되는 풍선 카테터 시스템의 일 실시예를 개념적으로 도시한 도면이다.
도 8a 내지 도 8c는 동맥 조직을 처치하는 풍선 카테터 시스템을 사용하는 방법을 도시한 도면이다.
전형적인 풍선 혈관 성형술 및 스텐트 삽입술을 대체하거나 개선하기 위하여 다양한 요법들이 개발되어 왔다. 배경 기술에서 상기한 많은 장치들은 동맥의 병든 조직을 절단하거나, 제거하거나, 기화시킨다. 예를 들어, 레이저 장치들은 플라크를 기화시켜 하류로 배출시킨다. 아테렉토미 장치들은 플라크를 잘라내어 신체 밖으로 빨아낸다. 동맥 내벽의 풍선을 절단하는 경우 조직을 손상시킬 수 있다.
절단하거나, 제거하거나, 기화시키지 않는 시스템과 장치를 제공하는 것이 바람직하다. 이러한 단점을 제거하는 세 가지 치료 양식은 다음과 같다: 조직의 냉각; 비제거적(non-ablative) 형식의 직접적인 분자의 변성(direct molecular denaturing); 및 비제거적 가열. 냉각은 보스턴 사이언티픽(Boston Scientific)의 크리오 캐스(Cryo-cath)와 같은 장치로 시행되어 왔다. 직접적인 분자의 변성은 예를 들어 감마선과 같은 방사선으로 실현될 수 있다. 본 발명은 나머지 치료 양식, 즉 비제거적 가열에 관한 것이다.
본 발명의 일부 실시예들은 일반적으로 조직 토폴로지의 지식 여부에 따라 동맥에서의 선택적인 에너지의 축적을 사용하여 병든 부위를 포함하는 동맥 조직을 가열하는 장치, 시스템 및 방법을 제공하는바, 이하에서 더욱 상세히 설명될 것이다.
본 발명은 동맥 내강을 개방하고 혈류를 증가시키기 위하여 부분적으로 폐쇄된 동맥을 따라 물질을 재형성하는 데에 특히 유용하다. 본 발명에서 개시하는 장치, 시스템 및 방법은, 예를 들어 대퇴동맥, 슬와동맥, 심장동맥, 및/또는 경동맥 등의 임의의 동맥에서 사용될 수 있다. 동맥 조직을 가열하는 장치들은 현재 출원중인 미국 특허 출원 제11/975,474호, 제11/975,383호, 제11/122,263호 및 미국 임시 출원 제61/099,155호에도 기재된 바 있으며, 이들의 기재 내용은 상호 참조에 의하여 본 출원의 일부로 한다.
기재 내용은 혈관계통의 기술에 사용될 것에 초점이 맞추어져 있으나, 이 기술은 임의의 내강의 폐쇄에도 역시 유용하다. 본 발명이 유용하게 사용될 수 있는 다른 해부학적 조직으로는, 식도, 구강, 비인두강, 이관 및 고실, 뇌의 부비강, 동맥계통, 정맥계통, 심장, 후두, 기관, 기관지, 위, 십이지장, 회장, 결장, 직장, 방광, 요관, 사정관, 정관, 요도, 자궁강, 질관, 자궁경관 등이 있다.
시스템의 일부 실시예들은 동맥의 확장과 함께 알맞은 가열(gentle heating)로 조직을 치료할 수 있다. 표준형 비가열식 혈관 형성술의 확장 압력과 대등하거나 그보다 현저히 낮은 확장 압력으로 풍선을 확장하기 전이나 확장한 후 또는 그 도중에 혈관벽의 가열이 수행될 수 있다. 예를 들어, 특정 병소에 있어서 표준형 혈관 형성술의 확장에는 10 내지 16 기압의 풍선 팽창 압력이 적합할 수 있음에 대하여, 본 명세서에 기재된 알맞은 가열과 결합된 수정된 확장 처치는 10 내지 16 기압으로부터 6 기압 또는 그 이하에서도 효과를 발휘하며, 특히 1 내지 2 기압의 저압에서도 가능하다. 동맥 플라크의 석회화가 일어난 경우, 병든 동맥을 재형성하고 개방하는 것은 더욱 어렵고, 따라서 카테터에는 칼슘을 부수고 내강을 재형성하여 개방하기 위해 초음파 에너지와 결합된 표준형 혈관 형성술의 풍선이 사용될 수도 있다.
혈관의 확장 전, 후 또는 도중에 추가되는 상기 알맞은 가열은 복잡함을 덜어주면서도 확장의 효과는 증대시킬 수 있다. 풍선 확장과 함께 수행되는 통제된 가열과 같은 실시예에 의하면, 삽입물에 의한 단점 없이 스텐트와 같은 확장의 혜택 중 최소한 일부를 제공하면서도 되꼬임은 감소시킬 수 있다. 알맞은 가열의 혜택(및/또는 복잡성의 제거)은 유해 반응 문턱값(deleterious response threshold) 아래로 외막층의 가열을 제한함으로써 향상될 수 있다. 다양한 사례에서, 내막 및/또는 중막(media)의 이러한 가열은 약 10초 이하 또는 종종 3초 (또는 심지어 2초) 보다 더 짧은 시간 동안의 가열을 사용함으로써 제공될 수 있다. 다른 사례에서는 더 긴 시간 동안 더 낮은 동력이 사용될 수도 있다.
신체 조직의 가열은, 전형적으로 라디오 주파수(RF) 에너지, 마이크로파(microwave) 에너지 및/또는 초음파 에너지와 같은 형식의 에너지의 인가를 수반한다. 이러한 에너지는 신체 조직의 온도를 한정하도록 제어된다. 일부 실시예에 있어서, 신체 조직의 온도 범위는, 인가된 에너지와 조직의 타입(tissue type)에 따라 약 50℃ 내지 약 90℃이다.
본 명세서에 기재된 방법들과 장치들은 혈관의 조직 처치에 있어 선택적이지 않으며, 동심성 및 편심성 동맥 경화증 모두를 위한 처치에 사용될 수 있다. 동맥 경화증은 50% 이상 또는 75% 이상의 경우에 혈관축에 대하여 편심성이기 때문에 이러한 비선택적 처치는 특별한 이점을 갖는다.
본 발명은 스텐트 삽입술과 결합되어 사용될 수도 있지만, 스텐트 삽입술이 선택되기 어려운 혈관의 개방 직경을 증가시키는데에 특히 적합하다. 가능한 응용으로서, 동맥 경화증이 특정 영역에서 국지적이기 보다는 동맥의 상당한 길이를 따라 확산되는 확산성(미만성) 질환의 처치가 포함된다. 본 발명은 또한, 많은 혈관이 예리하게 굴곡진 곳에서는 스텐트의 진입이나 확장이 필요하지 않기 때문에, 사행(蛇行)성의 예리하게 굴곡진 혈관의 처치에도 유용하다. 추가적인 유용한 응용으로서는, (곁가지의 폐색이 문제가 되는) 분지를 따라가는 처치와, (압궤 및/또는 스텐트의 파열 상실이 문제가 될 수 있는) 다리, 발 및 팔들과 같은 주변 사지의 처치가 포함될 수 있다.
본 명세서에 개시된 시스템은 적어도 에너지원(energy source) 및 신체 내강에 근접한 신체 조직 영역을 가열하도록 구성된 에너지 전달부(energy delivery portion)을 포함하는 카테터를 포함하되, 상기 영역은 건강한 조직과 같은 제1 조직 타입과, 병든 조직과 같은 제2 조직 타입의 모두를 포함한다. 상기 카테터는 현재 동맥 질환의 처치에 널리 사용되는 풍선 카테터와 유사한 것일 수 있으나, 가열을 위한 전극이 추가되었다는 점에서 다르다. 다른 실시예에서는, 혈관벽에 초음파 가열을 인가하기 위하여 풍선에 배치된 변환기(transducer), 또는 혈관벽에 마이크로파 가열을 인가하기 위하여 풍선에 배치된 마이크로파 안테나가 사용될 수도 있다. 상기 에너지원은, 장기적인 폐쇄 반응을 유발할만한 열적 손상을 신체 처치 영역에 야기하지 않으면서도 상기 신체 처치 영역 내의 조직을 치료적으로 처치하도록, 상기 에너지원으로부터 상기 에너지 전달부로 전송된 펄스형 에너지(pulsed energy)의 펄스 특성을 제어하기 위한 프로세서(processor)에 결합될 수 있다.
사용중에, 카테터 본체(cathether body)의 에너지 전달부는 가열될 신체 조직 영역에 근접한 내강 내에 위치한다. 펄스 특성(pulse characteristic)은 제1 조직 타입의 열 속성(thermal property)에 따라 결정되며, 펄스형 에너지는 상기 신체 조직 영역을 치료적으로 처치하도록 에너지 전달부로부터 펄스 특성에 따라 인가된다.
도 1은 동맥 조직을 가열하기 위한 카테터 시스템 10의 일 실시예를 도시한 도면이다. 상기 카테터 시스템 10은 풍선 카테터 12를 포함하되, 상기 카테터 12는 근위단(proximal end) 16 및 원위단(distal end) 18을 구비한 카테터 본체 14를 포함한다. 카테터 본체 14는 유연하며, 카테터 축 15를 정의하고, 가이드와이어 내강(guidewire lumen) 22 및 팽창 내강(inflation lumen) 24 (도 2 참조)과 같은 하나 또는 그 이상의 내강을 포함할 수 있다. 관류(perfusion), 유체의 전달(fluid delivery), 이미징(imaging) 등과 같은 다른 처치 또는 응용이 바람직한 경우에는 추가적인 내강이 제공될 수도 있다. 카테터 12는, 원위단 18에 인접한 팽창 가능한 풍선 20과, 근위단 16에 인접한 하우징 29를 포함한다. 하우징 29는, 가이드와이어 내강 22와 소통하는 제1 코넥터 26과, 팽창 내강 24와 유체 소통(fluid communication)하는 제2 코넥터를 포함한다. 팽창 내강 24는 풍선 20과 제2 코넥터 28 사이에서 연장된다. 제1 및 제2 코넥터 26 및 28은 선택적으로 루어-록(Luer-Loc, 등록상표) 코넥터와 같은 표준형 코넥터를 포함할 수 있다. 먼 쪽 끝(distal tip)은 가이드와이어 등과 같은 것이 통과될 수 있도록 하기 위한 집체형 팁 밸브(integral tip valve)를 포함할 수 있다.
하우징 29는 또한 전기 코넥터 38을 포함한다. 코넥터 38은, 각각 도체 36을 통해 전극 34에 전기적으로 결합된 복수의 전기 코넥터를 포함한다. 이로 인해, 전극 34는 용이하게 에너지를 공급받을 수 있는바, 전극 34는 종종 제어기 40 및 에너지원 42에 의해 에너지를 공급받으며, 상기 에너지원은 쌍극 또는 단극 RF 에너지, 마이크로파 에너지, 초음파 에너지 또는 기타 적합한 에너지원을 포함한다. 본 발명의 일 실시예에 의하면, 전기 코넥터 38은 제어기 40을 거쳐 RF 발전기에 결합되며, 상기 제어기 40은 에너지가 전극 34로 선택적으로 향하도록 한다. 단극 RF 에너지가 인가될 때, 환자측 접지는 (예를 들면) 외부 전극 또는 카테터 본체 14의 전극에 의하여 제공된다.
본 발명의 일부 실시예에 의하면, 제어기 40은 처치를 제어 또는 기록하기 위한 프로세서를 포함하거나 그러한 프로세서에 결합된다. 상기 프로세서는 전형적으로 컴퓨터 하드웨어 및/또는 소프트웨어를 구성하며, 종종 이하에 기재된 방법의 하나 또는 그 이상의 일부 또는 전부를 수행하기 위한 기계 가독성 프로그램 명령 또는 코드를 실행하는 하나 또는 그 이상의 프로그램 가능한 프로세서 유닛(processor unit)을 포함한다. 상기 코드는 종종 메모리(선택적으로 리드 온리 메모리, 랜덤 억세스 메모리, 비휘발성 메모리 등) 및/또는 기록 매체(플로피 디스크, 하드 드라이브, CD, DVD, 비휘발성 고체 상태 메모리 카드(Solid-state memory card) 등과 같은 것)와 같은 유형적 매체에 수록된다. 상기 코드 및/또는 관련 데이터와 신호는 또한 네트워크 접속(무선 네트워크, 이더넷, 인터넷, 인트라넷 등과 같은 것)을 통해 프로세서로 또는 프로세서로부터 전송될 수 있으며, 상기 코드의 일부 또는 전체는 하나 또는 그 이상의 버스를 통해 카테터 시스템 10과 프로세서 내의 사이에서 또한 전송될 수 있으며, 적합한 표준형 또는 전용 통신 카드, 코넥터, 케이블 등은 종종 상기 프로세서에 포함될 수 있다. 종종 소프트웨어 코드로 상기 프로세서를 프로그램함으로써 여기에 기재된 연산 및 신호 전송 단계의 적어도 일부분을 수행하도록 프로세서를 구성할 수 있으며, 상기 소프트웨어 코드는 단일 프로그램, 일련의 개별 서브루틴이나 관련 프로그램 등으로서 기록될 수 있다. 상기 프로세서는 표준형 또는 전용 디지털 및/또는 아날로그 신호 처리 하드웨어, 소프트웨어 및/또는 펌웨어를 구성할 수 있으며, 전형적으로 환자를 처치하는 동안 여기에 기재된 연산을 수행하기에 충분한 처리 성능을 갖는다. 또한 상기 프로세서는 선택적으로 개인용 컴퓨터(PC), 노트북 컴퓨터, 태블릿 컴퓨터, 전용 프로세싱 유닛, 또는 이들의 결합을 구성할 수 있다. 현대 컴퓨터 시스템과 연관된 표준형 또는 전용 입력 장치(마우스, 키보드, 터치 스크린, 조이스틱 등과 같은 것)와 출력 장치(프린터, 스피커, 디스플레이 등과 같은 것)가 또한 포함될 수 있으며, 복수의 프로세싱 유닛(또는 별개의 컴퓨터)를 구비한 프로세서도 넓은 범위의 집중형 또는 분산형 데이터 처리 구조에 채용될 수 있다.
도 2를 참조하면, 풍선 20이 더욱 상세하게 도시되어 있다. 풍선 20은 일반적으로 팽창 내강 24에 결합된 근위부(proximal portion) 30과, 가이드와이어 내강 22에 결합된 원위부(distal portion) 32를 포함한다. 풍선 20은 유체 또는 가스로 팽창될 때 방사상으로 확장된다. 본 발명의 일부 실시예에 의하면, 상기 유체 또는 가스는 비전도성일 수 있으며 그리고/또는 냉각될 수 있다. 본 발명의 일부 실시예에 의하면, 풍선 20은 동맥 조직에 접촉하도록 압력이 가해진 저압 풍선일 수 있다. 본 발명의 다른 실시예에 의하면, 풍선 20은 동맥 조직의 가열과 동맥 내강의 확장 모두를 할 수 있는 고압의 혈관 형성술 풍선이다. 풍선 20은, 특히 사용후 제거를 위하여 방사상으로 확장, 팽창된 구성으로부터 수축된 구성으로 풍선을 재구성할 수 있는 나선형 주름(helical fold)을 구비한 순응식(compliant) 또는 비순응식(non-compliant) 풍선을 구성할 수도 있다.
전극 34는, 전극으로부터 근위측으로 연장된 연관 도체 36과 함께 풍선 20의 표면에 장착된다. 전극 34는 풍선 20상에서 다양한 서로다른 패턴 또는 배열로 배치될 수 있다. 상기 시스템은 단극 또는 쌍극 에너지 응용에 사용될 수 있다. 단극 에너지의 전달을 위해, 접지 전극 패드와 같은 접지 전극이 카테터의 축 또는 환자의 피부 등에 사용된다. 쌍극 에너지의 전달을 위해서는 인접한 전극들이 축방향으로 오프셋되는데, 이는 인접한 원주상의 (축방향으로 오프셋된) 전극 사이로 쌍극 에너지가 향할 수 있도록 하기 위한 것이다. 본 발명의 다른 실시예에 의하면, 전극은, 쌍극 에너지가 인접한 원위성 및 근위성 전극들 사이로 향할 수 있도록 하기 위하여 풍선 주위에 밴드(band)형으로 배열될 수도 있다. 본 발명의 일부 실시예에 의하면, 전극 34는 풍선 20 내에 위치할 수도 있다. 전극 34는 풍선 20에서 다양한 서로 다른 패턴 또는 배열로 배치될 수 있다. 상기한 바와 같이, 다른 실시예는 풍선 20의 표면에 장착된 초음파 변환기 또는 마이크로파 안테나를 포함한다.
여기에서 논의되는 실시예는, 조직 토폴로지의 지식 여하에 따른 동맥 조직에서의 에너지의 선택적 축적이라는 개념을 중심으로 삼는다. 이것은 건강한 조직과 병든 조직 사이의 조직 속성의 차이를 이용함으로써 성취될 수 있다. 서로 다른 속성을 갖는 조직의 선택적인 가열은 서로 다른 조직의 위치나 타입을 알지 못하여도 성취될 수 있다. 만약 제1 조직 타입이 제2 조직 타입보다 더 큰 열전도율(thermal conductivity)(k)을 갖는다면, 그것은 열을 더 빨리 방출할 것이다. 만약 제2 조직 타입이 제1 조직 타입보다 더 낮은 비열용량(specific heat capacity)(cp)를 갖는다면, 같은 질량 (및 부피: 유사한 조직 밀도를 가정하는 경우)에 같은 양의 에너지가 인가된 경우 온도가 더 빨리 상승할 것이다. 만약 제1 조직 타입이 더 밀집된 혈관 구조를 갖고 있거나 또는 믿을만하게 관류가 양호한 영역에 인접한 경우, 제2 조직 타입보다 더 빠르게 열을 방출할 것이다.
본 발명은 다음과 같은 특성을 하나 또는 그 이상 갖는 타입의 조직을 선택적으로 가열할 수 있게 한다. 즉:
- 상대적으로 열악한(낮은) 열 전도성,
- 낮은 비열용량,
- 덜한 선천적 혈액 관류, 및/또는
- 상대적으로 관류가 양호한 영역으로부터 더 먼 거리.
병든 조직의 경우, 상기한 모든 특성이 적용된다. 이러한 질병은 지질 지방성 질병 조직 및/또는 섬유질 콜라겐성 조직으로 이루어진다. 이러한 조직들은 모두 건강한 혈관 조직 특히 중막(media)보다 낮은 비열용량과 낮은 열전도율을 갖는다. 건강한 혈관 조직은 또한 더 많은 미세 혈관 조직 구조를 가지며 관류가 양호한 조직에 더 가까이 위치하므로, 건강한 조직은 교통 체증과 같은 열 플럭스(heat flux)의 "역류(backing up)" 없이 더 효율적으로 열을 방출시킨다.
조직 속성의 이러한 차이를 이용하는 열쇠는 다음과 같다. 즉, 열은, 예컨대 펄스폭 변조(PWM) 방식을 사용하여, 관련된 조직의 열적 시상수(thermal time constant)에 적합한 속도로 조직내에 인가되거나 생성된다. 각 "펄스" 동안에, 조직 타입에 무관하게 동일한 양의 에너지가 전달되거나 생성된다. 조직의 토포그래피(topography)는 알 수 없을 수도 있으므로, 같은 "처치"가 모든 곳에 적용된다. 그러나, 병든 조직에서는 더 낮은 열용량을 가지므로 모든 곳에서 더 높은 온도 프로파일(temperature profile)을 가질 것이다. 상기 병든 조직은 더 낮은 열전도율을 가지므로 더 긴 열적 시상수를 가지게 되고 따라서 더 오랜 시간 동안 열을 보유할 것이다. 그러므로, 건강한 조직은 천천히 가열되고 빠르게 식을 것이며, 이것이 바로 본 특허 출원이 바라는 것이다. 병든 조직은 가열하고 건강한 조직은 가열하지 않는 것이 본 발명의 목표이다. 다음으로, 건강한 조직이 열적 손상을 입지 않도록 하는 특정 시간을 넘지 않게, 건강한 조직은 식으며 적절히 열을 방출할 수 있도록 펄스간 시간의 크기를 조정한다.
도 3은 일정한 열 또는 에너지 펄스 속도로 건강한 조직 110과 병든 조직 120을 가열하는 경우의 온도 대 시간 곡선을 도시한 도면이다. 병든 조직의 온도는 건강한 조직보다 더 빠르게 상승하고 느리게 냉각되며, 따라서 열이 축적되고 건강한 조직보다 현저히 강한 처치를 받게 된다.
도 4는 다른 속도로 열 또는 에너지를 인가한 경우 건강한 조직과 병든 조직을 모두 갖는 조직의 또 다른 온도 대 시간 곡선을 도시한 도면이다. 도시된 바와 같이, 조직 온도를 더욱 빨리 상승시키기 위해서 초기에 (처치를 시작하면서) 빠르게 열을 인가하거나 생성할 수 있음을 볼 수 있다. 이것은 동력 변조 또는 가변 펄스폭을 갖는 PWM을 사용하여 실현할 수 있다. 이것의 목적은 조직을 빠르게 가열하고 건강한 조직이 펄스 사이에 열을 소실할 수 있게 하는 것으로서, 특정 온도를 달성하는데 (그리고 필요하다면 머무르는데) 소요되는 전체 처치 시간을 감소시킨다.
* 시상수:
Figure pct00001
여기서 건강한 조직의 t
Figure pct00002
7s이며, 병든 조직의 t
Figure pct00003
14s이다.
* 열용량
중막 cp
Figure pct00004
3.9
외막 cp
Figure pct00005
3.1
지방 cp
Figure pct00006
2.4
* 열전도율
중막 k
Figure pct00007
0.59
외막 k
Figure pct00008
0.49
지방 k
Figure pct00009
0.20
상기한 "시상수"는 열적 시상수이다. 이것은 독립된 체적의 특정 조직이 그 열(그리하여 온도)의 대략 63%를 소실하는 데에 소요되는 시간으로서, 지수함수적으로 감소한다. 상기 열적 시상수는 열전도율과 직접적으로 비례한다. 그러므로, 지방성 질병 조직과 건강한 중막 조직의 열전도율에는 대략 2:1의 비율이 존재하므로, 그들의 시상수에도 역시 2:1의 비율이 존재한다.
건강한 조직의 열적 시상수는, 32mm3의 처치 체적, 0.5W/m/K의 열전도율, 32mm2의 열적 전면 단면적, 및 3.6J/g/K의 비열용량에 기초하여 7초로 예측되었다. 이 경우, 예를 들어 35초, 70초, 등과 같은 시상수의 몇 배의 기간 동안에 걸쳐 적절한 치료적 투여량(therapeutic dose)의 에너지를 전달할 수 있다.
도 5는 온도에 대한 열 소실의 효과를 시간에 대하여 도시한다. 열 소실은 지수형 감소에 따라 일어날 것이기 때문에, 냉각 속도는 시간에 따라 비선형적으로 변화할 것이다. 그래서, 주기는 동력 및 듀티 사이클(duty cycle)과 함께 적합하게 선택되어야 한다. 열 소실을 무시한 동력과 열용량은 가열 중의 온도 증가 속도를 결정할 것이다. 동력, 듀티 사이클, 열용량, 및 연속적 열 소실 속도의 조합은 평균 온도 변화 속도를 결정할 것이다. 열 소실이 없는 병든 조직 210과 건강한 조직 220은 모두 열을 소실하는 병든 조직 215과 건강한 조직 225보다 높은 평균 온도를 갖는다.
도 5에 대해서 주의해야 할 중요한 점은, 비교했을 때 열 소실의 속도가 상당할 정도로, 평균 동력(시간당 평균 에너지)이 충분히 낮아야 한다는 것이다. 다시 말해, 일정한 형태의 건강한 혈관 조직이 초당 2줄(2와트)의 속도로 효과적으로 에너지를 소실할 수 있다고 가정한다면, 그 영향이 현저해 질 수 있도록 에너지 인가의 평균 속도 또한 이 정도의 크기일 필요가 있다.
이것이 본 발명의 가장 중요한 점으로서, 조직의 속성에 있어서의 현저한 차이가 본 발명의 이점을 크게 상승시킬 수 있도록 에너지를 인가하는 평균 속도는 열적 시상수(thermal time constant)에 상응한다.
도 6은 시스템 10에 의한 쌍극 처치를 개략적으로 도시한다. 전극쌍 34A와 34B를 포함하는 풍선 20은 지방성 질병/괴사 중심 48, 섬유성의 질병/괴사 캡(cap) 44, 건강한 조직 45를 포함하는 동맥 내강 내에 위치된다. 처치는 전극쌍 34A 및 34B 간의 펄스형 에너지에 의해 건강한 조직 45와 지방성 질병/괴사 중심 48, 섬유성의 질병/괴사 캡 44에 대하여 행해진다. 상기 전극쌍들은 상기 풍선 상에 있는 임의의 전극쌍일 수도 있고, 예컨대, 일부 실시예에서는, 상기 전극쌍들은 34A와 34C, 34A와 34D, 또는 34A 내지 34D의 임의의 조합일 수도 있다. 이 배열은 조직을 통해 전극쌍 사이의 동맥 조직("재형성 구역")으로 에너지 또는 열("조직 재형성 에너지")을 전달하는 에너지 경로 50을 생성한다. 전극쌍의 다른 조합을 사용하면 중첩하는 쌍들을 사용함으로써 재형성 구역들 사이의 간격을 줄이거나 제거할 수 있다. 쌍극 에너지를 갖는 전극쌍들을 사용하면 단극 방식의 일부 잠재적인 문제점들을 피할 수 있다. 병든 동맥 조직 48은 건강한 동맥 조직 45보다 더 높은 전기 저항을 갖는다. 쌍극 시스템의 전극쌍 34A, 34B를 사용함으로써, 에너지 경로 50은, 상기 전극쌍 사이의 건강한 조직, 병든 조직, 또는 건강한 조직과 병든 조직 모두의 조합을 아우를 것이다. 임의의 수의 전극쌍들이 다른 패턴 또는 배열로 사용될 수 있다.
도 7은 시스템 10에 의한 단극 처치를 개략적으로 도시한다. 전극쌍 34A와 34B를 포함하는 풍선 20은 지방성 질병/괴사 중심 48, 섬유성 질병/괴사 캡 44, 건강한 조직 45을 포함하는 동맥 내강 내에 위치되고, 환자의 피부에 위치되는 것과 같은 하나 또는 그 이상의 전기적 접지(도시되지 않음)가 사용된다. 동력이 동맥 내강의 주변부 둘레에 배열된 다수의 단극 전극 34에 인가될 때, 에너지 54는 동맥 벽을 통해 방사상으로 외측을 향하고 병든 조직과 건강한 동맥 조직 모두를 처치한다.
펄스형 에너지에 의해 조직을 처치하는 카테터 시스템 10의 사용은 도 8a 내지 8c를 참조로 이해될 수 있다. 도 8a에 도시된 바와 같이, 처치 부위로의 접근은 병든 조직 48의 목표 영역에서 혈관 58 내에서 가이드와이어 56을 진행시키는 것을 포함한다. 풍선 20의 위치는, 방사선 불투과성 마커(radiopaque marker)에 의해 또는 방사선 불투과성 구조(또는 대응하는 방사선 불투과성 마커가 그 위에 또는 가까이에 위치된) 풍선 20, 그리고 방사선 불투과성 전극 34의 사용 중 어느 하나 또는 모두에 의해 용이하게 파악될 수 있다. 가이드와이어 56은 형광 투시(또는 다른) 이미징(imaging) 하에 위치될 수 있다.
카테터 12는 원위측(몸으로부터 먼 쪽)으로부터 가이드와이어 56 위로 진행되고 동맥 경화 물질 48에 인접하여 위치된다. 풍선 20은 혈관의 내강 내에서 방사상으로 확장되어 전극 34, 또는 전극 34A 및 34B가 방사상으로 동맥 조직과 결합된다. 병든 조직 48이 카테터 12에 대해서 비대칭적으로 분산되어 있을 수 있기 때문에, 전극 34는 병든 조직 48, 건강한 조직 60, 또는 이들 조직의 결합과 결합될 수 있다.
상기와 같이, 전극들 34는 풍선 둘레 주변에 배치된다. 펄스형 에너지는 전극 34 또는 인접한 전극쌍 34A와 34B를 향하고, 병든 조직 48과 건강한 조직 60을 모두 처치한다. 제어기 40은 0.1 내지 180초 동안 실질적으로 0.25 내지 5와트의 평균 동력으로, 또는 실질적으로 4 내지 45줄(J)의 에너지를 전극에 공급하기 위해 펄스형 에너지를 제공할 수 있다. 상기 동력 및 지속 시간은 심각한 손상을 일으킬 수 있을 정도의 양보다 작도록, 특히, 혈관 내의 조직을 제거할 수 있을 정도의 양보다 작도록 조정된다.
이제 도 8c를 참조하면, 상기한 바와 같이, 풍선 20은 동맥 내강의 개방과 가열을 결합하는 혈관 형성술(angioplasty) 풍선일 수 있고, 이로써 예컨대, 캡 구조를 적절히 가열하거나(캡의 비후화를 유도하고 플라크가 파열에 덜 취약하도록 하기 위함), 취약한 플라크의 지질이 풍부한 저류(pool)를 가열하도록(지질이 풍부한 저류를 재형성, 변성, 용융, 수축과 재분배 중 어느 하나 또는 모두를 할 수 있도록 하기 위함), 또는 상기 두 가지 모두가 수행되도록, 열이 선택적으로 병든 조직 48에 전달되고, 이때 건강한 조직 60은 손상 없이 열을 소실한다.
일부 실시예에서, 반복적으로 풍선 20이 수축되고 풍선 20을 재배치하기 위해 카테터 12의 축 방향 이동이 이용될 수 있으며, 이어서 병든 조직을 따라 복수의 처치 위치의 각각에서 풍선 20이 확장될 수 있다.
본 명세서에서는 일반적으로 혈관 구조와 관련하여 설명하였지만, 본 명세서에 개시된 카테터 장치, 시스템 및 방법들은 또한 앞서 논의된 바와 같이 서로 다른 조직 속성을 갖는 조직 타입들을 포함하는 인간의 해부학적 구조의 다른 관의 내강에서 응용 분야를 찾을 수 있다. 카테터가 위치되는 해부학적 구조는, 동맥 계통, 정맥 계통과 심장뿐 아니라, 예컨대, 식도, 구강, 비인두강(nasopharyngeal cavity), 이관(auditory tube)과 고실(tympanic cavity), 뇌의 부비강(sinus), 후두(larynx), 기관(trachea), 기관지(bronchus), 위, 십이지장, 회장(ileum), 결장(colon), 직장(rectum), 방광(bladder), 요관(ureter), 사정관(ejaculatory duct), 정관(vas deferens), 요도, 자궁강, 질관(vaginal canal), 및 자궁경관(cervical canal)일 수 있다.
예시로서 그리고 이해의 명확성을 위해 예시적인 실시예들이 상세히 설명되었지만, 당업자는 다양한 수정, 응용, 및 변경이 채용될 수 있음을 인식할 수 있을 것이다. 따라서, 본 발명의 영역은 단지 청구범위에 의해서만 한정될 수 있다.
110: 병든 조직
120: 건강한 조직
210: 열 소실이 없는 병든 조직
215: 열 소실이 있는 병든 조직
220: 열 소실이 없는 건강한 조직
225: 열 소실이 있는 건강한 조직

Claims (35)

  1. 신체 내강에 인접한 신체 조직 영역을 가열하는 방법에 있어서,
    상기 영역은 제1 조직 타입과 제2 조직 타입을 포함하고,
    상기 방법은,
    가열되어야 할 신체 조직 영역에 인접한 내강 내에 카테터의 에너지 전달부를 위치시키는 단계;
    상기 제1 조직 타입의 열 속성에 따라 펄스 특성을 결정하는 단계; 및
    상기 제1 조직 타입에 대한 현저한 열 손상을 방지하는 속도로 상기 제2 조직 타입에서 열을 증가시키면서 상기 제1 조직 타입으로부터 열이 방출되게 함으로써, 상기 신체 조직 영역 내의 상기 제2 조직 타입을 치료적으로 처치하도록 상기 에너지 전달부로부터 상기 펄스 특성을 갖는 펄스형 에너지를 인가하는 단계
    를 포함하는 신체 조직 영역 가열 방법.
  2. 제1항에 있어서,
    상기 펄스형 에너지는 상기 제1 조직 타입보다 상기 제2 조직 타입을 선택적으로 가열하고,
    상기 선택적인 가열은 적어도 부분적으로, 상기 제1 조직 타입의 열 전도보다 더 낮은 열 전도, 상기 제1 조직 타입의 비열용량보다 더 낮은 비열용량, 상기 제1 조직 타입의 선천적 혈액 관류(blood perfusion)보다 더 적은 선천적 혈액 관류, 관류가 양호한 영역들로부터의 거리가 관류가 양호한 영역들과 상기 제1 조직 타입 사이의 거리보다 더 먼 것 중 일부 또는 전부를 포함하는, 상기 제2 조직 타입의 특성 그룹 중 하나 또는 그 이상에 의해 유도되는 신체 조직 영역 가열 방법.
  3. 제2항에 있어서,
    상기 그룹의 특성들의 대부분은, 상기 제2 조직 타입에서 열이 증가하도록 하면서 상기 제1 조직 타입에 대한 현저한 열 손상을 방지하는 속도로 상기 제1 조직 타입으로부터 열이 방출되게 하는 신체 조직 영역 가열 방법.
  4. 제1항에 있어서,
    상기 펄스형 에너지는 상기 신체 조직 영역에 0.25 내지 5와트(watt)의 평균 속도로 전달되는 신체 조직 영역 가열 방법.
  5. 제1항에 있어서,
    상기 펄스형 에너지의 각각의 펄스는 상기 신체 조직 영역에 4 내지 45줄(Joule)을 제공하는 신체 조직 영역 가열 방법.
  6. 제1항에 있어서,
    상기 신체 조직 영역에 전달되는 펄스형 에너지의 평균 속도는 상기 제1 조직 타입에 의한 에너지 소실 속도의 실질적으로 0.1배 내지 10.0배인 신체 조직 영역 가열 방법.
  7. 제1항에 있어서,
    펄스들 사이의 기간은 상기 펄스형 에너지에 의한 상기 제1 조직 타입에 대한 열 손상을 방지하기에 적절하도록 상기 제1 조직 타입이 그 열을 소실하게 하는 신체 조직 영역 가열 방법.
  8. 제1항에 있어서,
    에너지의 펄스들 사이의 기간은 0.1 내지 180초인 신체 조직 영역 가열 방법.
  9. 제1항에 있어서,
    상기 제1 조직 타입에 대한 열적 시상수(thermal time constant)는 특정 조직의 독립된 체적이 지수형 감소를 겪으면서 그 열의 대략 63%를 잃는데 걸리는 시간인 신체 조직 영역 가열 방법.
  10. 제1항에 있어서,
    상기 펄스형 에너지는 제1 조직 타입 시상수의 적어도 몇 배인 지속 시간에 걸쳐 상기 신체 조직 영역으로 전달되고, 상기 제1 조직 타입의 열적 시상수는 상기 제1 조직 타입의 열 전도율에 비례하는 신체 조직 영역 가열 방법.
  11. 제10항에 있어서,
    상기 열적 시상수는 상기 제1 조직 타입의 열전도율에 비례하는 신체 조직 영역 가열 방법.
  12. 제11항에 있어서,
    상기 제2 조직 타입의 열전도율은 상기 제1 조직 타입의 열전도율의 두 배인 신체 조직 영역 가열 방법.
  13. 제1항에 있어서,
    에너지원은 무선 주파수(RF) 에너지원을 포함하는 신체 조직 영역 가열 방법.
  14. 제13항에 있어서,
    상기 에너지 전달부는, 신체 내강에 대향하여 복수의 전극 표면과 결합하는 방사상으로 확장가능한 구조를 포함하고,
    상기 신체 내강에 대향하는 상기 복수의 전극 표면은 상기 제1 조직 타입과 상기 제2 조직 타입을 포함하는 복수의 회로를 완성하고,
    상기 펄스형 에너지는 상기 복수의 회로로 전달되는 신체 조직 영역 가열 방법.
  15. 제1항에 있어서,
    에너지원은 레이저 에너지원을 포함하는 신체 조직 영역 가열 방법.
  16. 제15항에 있어서,
    상기 에너지 전달부는, 적어도 하나의 광 도관에 연결된 적어도 하나의 방사상으로 배열된 윈도우를 포함하고, 상기 광 도관은 신체 조직 영역으로의 펄스형 에너지의 전송을 위해 카테터 본체의 근위단과 적어도 하나의 윈도우 사이에서 연장되는 신체 조직 영역 가열 방법.
  17. 제1항에 있어서,
    에너지원은 신체 조직 영역으로 펄스형 초음파 에너지를 전달하기 위한 초음파 전송기를 포함하는 신체 조직 영역 가열 방법.
  18. 제1항에 있어서,
    에너지원은 마이크로파 에너지원을 포함하고, 상기 마이크로파 에너지원은 신체 조직 영역으로 펄스형 마이크로파 에너지를 전달하기 위한 적어도 하나의 마이크로파 안테나를 포함하는 신체 조직 영역 가열 방법.
  19. 신체 내강에 인접한 신체 조직 영역을 가열하는 카테터 시스템에 있어서,
    상기 영역은 제1 조직 타입과 제2 조직 타입을 포함하고,
    상기 카테터 시스템은,
    근위단 및 원위단과 이들 사이의 축을 포함하는 긴 가요성 카테터 본체;
    상기 원위단에 근접한 에너지 전달부;
    상기 에너지 전달부에 연결된 에너지원; 및
    상기 에너지원에 연결된 프로세서를 포함하되,
    상기 프로세서는, 상기 제1 조직 타입에 대한 현저한 열 손상을 방지하는 속도로 상기 제2 조직 타입에서 열을 증가시키면서 상기 제1 조직 타입으로부터 열이 방출되게 함으로써, 상기 신체 조직 영역 내의 상기 제2 조직 타입을 치료적으로 처치하도록 상기 에너지원으로부터 상기 에너지 전달부로 전송되는 펄스형 에너지의 펄스 특성을 제어하는 카테터 시스템.
  20. 제19항에 있어서,
    상기 펄스형 에너지는 상기 제1 조직 타입보다 상기 제2 조직 타입을 선택적으로 가열하고,
    상기 선택적인 가열은 적어도 부분적으로, 상기 제1 조직 타입의 열 전도보다 더 낮은 열 전도, 상기 제1 조직 타입의 비열용량보다 더 낮은 비열용량, 상기 제1 조직 타입의 선천적 혈액 관류(blood perfusion)보다 더 적은 선천적 혈액 관류, 관류가 양호한 영역들로부터의 거리가 관류가 양호한 영역들과 상기 제1 조직 타입 사이의 거리보다 더 먼 것 중 일부 또는 전부를 포함하는, 상기 제2 조직 타입의 특성 그룹 중 하나 또는 그 이상에 의해 유도되는 카테터 시스템.
  21. 제20항에 있어서,
    상기 그룹의 특성들의 대부분은, 상기 제2 조직 타입에서 열이 증가하도록 하면서 상기 제1 조직 타입에 대한 현저한 열 손상을 방지하는 속도로 상기 제1 조직 타입으로부터 열이 방출되게 하는 카테터 시스템.
  22. 제19항에 있어서,
    상기 펄스형 에너지는 상기 신체 조직 영역에 0.25 내지 5와트(watt)의 평균 속도로 전달되는 카테터 시스템.
  23. 제19항에 있어서,
    상기 펄스형 에너지의 각각의 펄스는 상기 신체 조직 영역에 4 내지 45줄(Joule)을 제공하는 카테터 시스템.
  24. 제19항에 있어서,
    상기 신체 조직 영역에 전달되는 펄스형 에너지의 평균 속도는 상기 제1 조직 타입에 의한 에너지 소실 속도의 실질적으로 0.1배 내지 10.0배인 카테터 시스템.
  25. 제19항에 있어서,
    펄스들 사이의 기간은 상기 펄스형 에너지에 의한 상기 제1 조직 타입에 대한 열 손상을 방지하기에 적절하도록 상기 제1 조직 타입이 그 열을 소실하게 하는 카테터 시스템.
  26. 제19항에 있어서,
    펄스형 에너지의 펄스들 사이의 기간은 0.1 내지 180초인 카테터 시스템.
  27. 제19항에 있어서,
    상기 제1 조직 타입에 대한 열적 시상수(thermal time constant)는 특정 조직의 독립된 체적이 지수형 감소를 겪으면서 그 열의 대략 63%를 잃는데 걸리는 시간인 카테터 시스템.
  28. 제19항에 있어서,
    상기 펄스형 에너지는 제1 조직 타입 시상수의 적어도 몇 배인 지속 시간에 걸쳐 상기 신체 조직 영역으로 전달되고, 상기 제1 조직 타입의 열적 시상수는 상기 제1 조직 타입의 열 전도율에 비례하는 카테터 시스템.
  29. 제28항에 있어서,
    상기 제2 조직 타입의 열 전도율은 상기 제1 조직 타입의 열 전도율의 두 배인 카테터 시스템.
  30. 제25항에 있어서,
    에너지원은 무선 주파수(RF) 에너지원을 포함하는 카테터 시스템.
  31. 제30항에 있어서,
    상기 에너지 전달부는, 신체 내강에 대향하여 복수의 전극 표면과 결합하는 방사상으로 확장가능한 구조를 포함하고,
    상기 신체 내강에 대향하는 상기 복수의 전극 표면은 상기 제1 조직 타입과 상기 제2 조직 타입을 포함하는 복수의 회로를 완성하고,
    상기 펄스형 에너지는 상기 복수의 회로로 전달되는 카테터 시스템.
  32. 제19항에 있어서,
    에너지원은 레이저 에너지원을 포함하는 카테터 시스템.
  33. 제32항에 있어서,
    상기 에너지 전달부는, 적어도 하나의 광 도관에 연결된 적어도 하나의 방사상으로 배열된 윈도우를 포함하고, 상기 광 도관은 신체 조직 영역으로의 펄스형 에너지의 전송을 위해 카테터 본체의 근위단과 적어도 하나의 윈도우 사이에서 연장되는 카테터 시스템.
  34. 제19항에 있어서,
    에너지원은 신체 조직 영역으로 펄스형 초음파 에너지를 전달하기 위한 초음파 전송기를 포함하는 카테터 시스템.
  35. 제19항에 있어서,
    에너지원은 마이크로파 에너지원을 포함하고, 상기 마이크로파 에너지원은 신체 조직 영역으로 펄스형 마이크로파 에너지를 전달하기 위한 적어도 하나의 마이크로파 안테나를 포함하는 카테터 시스템.
KR1020117014112A 2008-11-17 2009-11-11 조직 토폴로지의 지식 여하에 따른 에너지의 선택적 축적 KR20110104504A (ko)

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