KR101856267B1 - Ecg-기반 카테터 팁 배치의 재확인 - Google Patents

Ecg-기반 카테터 팁 배치의 재확인 Download PDF

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KR101856267B1
KR101856267B1 KR1020137006933A KR20137006933A KR101856267B1 KR 101856267 B1 KR101856267 B1 KR 101856267B1 KR 1020137006933 A KR1020137006933 A KR 1020137006933A KR 20137006933 A KR20137006933 A KR 20137006933A KR 101856267 B1 KR101856267 B1 KR 101856267B1
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catheter
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켈리 비 파워스
짐 씨 비즐리
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씨. 알. 바드, 인크.
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Abstract

환자의 ECG 신호의 도움으로 맥관 내에 위치한 카테터 위치의 재확인이 개시되며, 따라서 환자 맥관 구조 내에서 이후의 카테터 재배치의 결정을 보조한다. 일 실시예에서, 환자 신체 내부의 유치 의료 장치의 위치를 재확인하기 위한 방법은 먼저 환자의 ECG 신호를 이용하여 환자의 신체 내부에 의료 장치를 배치시키는 것을 포함한다. 의료 장치의 초기 배치 완료 후의 유치 의료 장치의 초기 위치와 관련된 제1 ECG 신호 프로파일을 저장한다. 의료 장치의 초기 배치 이후의 유치 의료 장치의 위치와 관련된 제2 ECG 신호 프로파일을 그 후 획득한다. 유치 의료 장치의 이동이 발생했는지를 판단하기 위해 제1 ECG 신호 프로파일과 제2 ECG 신호 프로파일을 비교한다.

Description

ECG-기반 카테터 팁 배치의 재확인{RECONFIRMATION OF ECG-ASSISTED CATHETER TIP PLACEMENT}
관련 출원과의 상호 참조
본 출원은 "ECG-기반 카테터 팁 배치의 재확인 시스템"이라는 명칭으로 2010년 8월 20일에 출원된 미국 임시 특허 출원 번호 61/375,442호의 이익을 향유하며, 위 미국 출원은 본 명세서에서 그 전체로서 참조된다.
간단한 요약
간단하게 요약하면, 본 발명의 실시예는 환자의 ECG 신호의 도움으로 위치된 카테터 또는 다른 유치(indwelling, 留置) 장치의 위치 재확인에 대한 것이다. 본 명세서에 기재된 시스템과 방법은 임상의가 유치 카테터의 말단팁이 카테터가 처음 위치된 때와 같은 장소에 여전히 위치하는지 확인하는 것을 가능하게 해준다. 팁이 다른 위치로 이동된 것이 발견되면, 팁을 적절한 위치로 되돌리는 단계가 수행된다.
일 실시예에서, 환자 신체 내의 유치 의료 장치 위치의 재확인 방법은 먼저 환자 신체 내에 환자의 ECG 신호를 이용하여 의료 장치를 위치시키는 것을 포함한다. 의료 장치의 초기 배치가 완료된 후의 유치 의료 장치의 초기 위치에 관련된 제1 ECG 신호 프로파일은 저장된다. 의료 장치의 초기 배치 다음의 유치 의료 장치의 위치에 관련된 제2 ECG 신호 프로파일이 그 후 획득된다. 제1 ECG 신호 프로파일과 제2 ECG 신호 프로파일을 비교하여 의료 장치의 초기 배치 이후에 유치 의료 장치의 이동이 발생했는지를 판단한다. 만약 이동이 발생했다면, 임상의는 필요에 따라 카테터를 재위치시키기 위해 필요한 단계를 수행할 수 있다.
일 실시예에서, 환자 내부의 카테터의 위치를 재확인하기 위한 시스템이 제공된다. 카테터는 환자 심장의 ECG 신호 생성 결절 근처에 배치된다. 시스템은, 제1 ECG 신호 프로파일을 획득하기 위한 하나 이상의 전극 - 제1 ECG 신호 프로파일은 최종 대상 목적지에서 카테터의 초기 배치가 완료된 후의 환자 내의 카테터의 말단팁의 초기 위치에 관한 것이며, 하나 이상의 전극은 환자 내의 카테터 말단팁의 다음 위치에 관한 제2 ECG 신호 프로파일도 획득함 - 과, 적어도 제1 ECG 신호 프로파일을 저장하기 위한 저장 부품과, 저장 부품으로부터 제1 ECG 신호 프로파일을 수신하고 제2 ECG 신호 프로파일도 수신하며, 카테터의 말단팁의 다음 위치가 최종 대상 목적지에서 카테터의 초기 배치가 완료된 후의 초기 위치와 다른지 판단할 수 있도록 제1 및 제2 ECG 신호 프로파일과 관련된 데이터를 전달하는 ECG 신호 모니터를 포함한다.
일 실시예에서, 제1 ECG 신호 프로파일을 획득하기 위한 하나 이상의 전극은 환자의 신체 내 카테터 내부에 포함되고, 하나 이상의 전극은 도전 경로에 의해 조작 가능하게 ECG 신호 모니터에 연결된다.
일 실시예에서, 하나 이상의 전극은 카테터의 루멘 내에 배치된 탐침을 포함하고, 도전 경로는 하나 이상의 전극에 조작 가능하게 연결된 테터를 포함한다.
일 실시예에서, 하나 이상의 전극과 도전 경로는 카테터의 루멘 내에 배치된 전도성 용액을 포함한다.
일 실시예에서, 전도성 용액 안에는 전도성 와이어가 부분적으로 배치되고, 전도성 와이어는 카테터로부터 연장되고 ECG 신호 모니터에 조작 가능하게 연결된다.
일 실시예에서, 저장 부품은 카테터에 포함된 RFID칩을 포함하고, ECG 신호 모니터는 RFID칩의 제1 ECG 신호 프로파일을 암호화하고 판독하기 위한 RFID 인코더/판독기를 포함한다.
일 실시예에서, RFID칩은 필드 프로그래밍 가능한 칩이다.
일 실시예에서, 저장 부품은 카테터에 대해 원격으로 배치된다.
일 실시예에서, 저장 부품은 프로그래밍 가능한 자기 스트라이프를 포함하는 카드를 포함하고, ECG 신호 모니터는 카드 인코더/판독기를 포함한다.
일 실시예에서, ECG 신호 모니터는 원격의 장소로부터 제1 ECG 신호 프로파일을 무선으로 수신한다.
일 실시예에서, 제1 및 제2 ECG 신호 프로파일 중 적어도 하나는 배치 후 환자의 신체 외부에 남은 카테터 부분의 길이와, 추가적인 정보를 얻을 수 있는 웹 포탈 중 적어도 하나와 관련된 데이터를 포함한다.
일 실시예에서, ECG 신호 모니터는 환자 내부에 배치되는 하나 이상의 전극과, 환자의 피부에 배치되기 위한 두 개 이상의 전극을 포함한다.
일 실시예에서, 제1 전극은 제1 ECG 신호 프로파일을 획득하기 위해 사용되고, 제2 전극은 제2 ECG 신호 프로파일을 획득하기 위해 사용된다.
본 발명의 실시예의 이러한 및 다른 특징은 다음 기재 및 첨부 청구항에 의해 더 충분히 명백해지거나, 아래에 제시되는 것과 같이 본 발명의 실시예의 실시에 의해 학습 될 수 있다.
본 개시의 더 특정한 기재가 첨부 도면에 도시된 구체적인 실시예를 참조하여 제공될 것이다. 이러한 도면들은 본 발명의 전형적인 실시예만을 도시하며, 따라서 그 범위를 한정하는 것으로 간주하지 않는다는 것을 알 수 있다. 본 발명의 예시적인 실시예는 첨부 도면을 이용하여 추가적인 특성과 세부 사항과 함께 기재되고 설명될 것이다.
도 1은 본 발명의 예시적인 일 실시예에 따른 카테터의 혈관 내 배치를 위한 시스템의 다양한 요소를 도시하는 블록도이다.
도 2는 환자와 도 1의 시스템의 보조로 그 안에 삽입되는 카테터의 단순화된 도면이다.
도 3은 일 실시예에 따른 도 2의 카테터 내부의 도전 경로 구조의 일부 절단도이다.
도 4는 일 실시예에 따른 사용을 위한 카드 판독기/인코더 시스템의 사시도이다.
도 5는 일 실시예에 따른 RFID 칩을 포함하는 카테터 분기의 평면도이다.
도 6은 RFID 판독기/인코더의 단순화된 평면도이다.
도 7은 일 실시예에 따른 도 2의 시스템 디스플레이의 스크린샷으로, 시스템 이용 중에 카테터의 위치 확인에 있어 복수의 ECG 파형을 보여주고 있다.
유사한 구조가 유사한 도면 부호를 갖는 도면을 참조할 것이다. 도면이 본 발명의 예시적인 실시예를 도식적이면서 개략적으로 묘사하고 있으며, 스케일에 있어 반드시 그렇지도 않고 한정되지도 않는다는 점을 알 수 있다.
명확성을 위해, 단어 "전단(proximal)"은 본 명세서에 기재된 장치를 이용하는 임상의에게 상대적으로 가까운 방향을 나타내는 반면, 단어 "말단(distal)"은 임상의에게 상대적으로 먼 방향을 나타낸다는 것을 이해해야 한다. 예컨대, 신체 외부에 남아있는 카테터 단부는 카테터의 전단부인 반면, 환자의 신체 내에 위치된 카테터의 단부는 카테터의 말단부로 간주된다. 또한, 청구항을 포함하여 본 명세서에서 사용되는 "포함하는(including)", "가지다(has)", 및 "가지는(having)"이라는 단어는 "포함한다(comprising)"와 같은 단어와 동일한 의미를 가질 것이다.
본 발명의 실시예는 일반적으로 환자의 ECG 신호의 도움으로 위치된 카테터 또는 다른 유치 장치의 위치 재확인에 관한 것이다. 본 명세서에 설명된 바와 같이, 본 명세서에 기재된 시스템과 방법은 특히 임상의가 유치 카테터의 말단팁이 카테터가 처음 위치된 때와 같은 장소에 여전히 위치하는지 확인하는 것을 가능하게 해준다. 팁이 다른 위치로 이동된 것이 발견되면, 팁을 적절한 위치로 되돌리는 단계가 수행된다.
대체로 10으로 지정된 카테터 배치 및 모니터링 시스템의 일례가 도시된 도 1과 도 2에 대해 먼저 살펴본다. 시스템(10)은 초음파 이미징을 통해 환자(70)의 피하 혈관의 시각화를 가능하게 하며, 뒤이어 환자 심장의 동방 결절(SA node)에서 방출되는 ECG 신호의 감시를 통해 환자의 맥관 구조(vasculature) 내에 카테터(72)가 삽입, 전진 및 최종 배치된다. 시스템(10)의 하드웨어 및 다른 부품의 단순화된 블록도가 도 1에 도시되어 있고, 도 2는 환자(70)에 관련된 시스템 및 카테터(72)를 도시한다. 도시한 바와 같이, 일 실시예의 시스템(10)은 디스플레이(30), 초음파 프로브(40) 및 환자(70) 가슴에 배치하기 위한 센서 유닛(50)을 수용하는 콘솔(20)을 일반적으로 포함한다.
구체적으로 상술한 바와 같이, 도 2는 피부 삽입 장소(73)를 통해 카테터(72)를 환자 맥관 구조에 위치시키는 시술 중에 시스템(10)의 부품과 환자(70)의 일반적인 관계를 도시한다. 도 2는 배치가 완료된 후에 환자 외부에 남아있는 전단부(74)와 환자 맥관 구조 내에 있는 말단부(76)를 일반적으로 포함하는 카테터(72)를 도시한다. 시스템(10)은 궁극적으로 카테터(72)의 말단팁(76A)을 환자 맥관 구조 내의 원하는 위치에 위치시키기 위해 사용된다. 일 실시예에서, 카테터 말단팁(76A)의 원하는 위치는 상대 정맥(Superior Vena Cava, "SVC")의 하단 삼분의 일 부분에서와 같이 환자의 심장에 가깝다. 물론, 시스템(10)은 카테터 말단팁을 다른 위치에 위치시키는데 사용될 수도 있다. 카테터 전단부(74)는 카테터(72)의 하나 이상의 루멘(lumens)과 허브로부터 전단으로 연장하는 하나 이상의 연장 다리(extension legs; 74B) 사이의 유체 연통(fluid communication)을 제공하는 분기(74A)를 더 포함한다. 각각의 연장 다리(74B)는 적절한 의료 장치에 부착하기 위한 루어 커넥터(luer connector; 74C)를 포함한다.
콘솔(20)은 시스템(10)의 작동에 필요한 다양한 부품을 수용한다. 예컨대, EEPROM 같은 비휘발성 메모리를 포함하는 프로세서(22)는 시스템(10)의 작동 동안 시스템 기능 제어를 위해 콘솔(20)에 포함되며, 따라서 제어 프로세서처럼 작동한다. 디지털 컨트롤러/아날로그 인터페이스(24) 또한 콘솔(20)에 포함되며, 초음파 프로브(40), 센서(50) 및 다른 시스템 부품 사이의 인터페이싱을 통제하기 위해 프로세서(22)와 다른 시스템 부품 모두와 함께 통신한다.
콘솔(20)은 프린터, 기억 매체, 키보드 등을 포함하는 선택적인 부품(54) 및 센서(50)와의 접속용 포트(52)를 더 포함한다. 일 실시예에서 포트(52)는 USB 포트이며, 다른 포트형 또는 포트형의 조합이 이것과 본 명세서에 기재된 다른 인터페이스 접속을 위해 이용될 수 있다. 콘솔(20)은 외부 전원(58)과의 조작 가능한 접속을 가능하게 하기 위해 전력 접속부(56)를 포함한다. 내부 전원(60)은 또한 외부 전원과 함께 또는 그것 없이 사용될 수 있다. 전력 관리 회로(59)는 전력 사용과 분배를 조절하기 위해 콘솔의 디지털 컨트롤러/아날로그 인터페이스(24)에 포함된다.
본 실시예에서 시스템(10)의 디스플레이(30)는 콘솔(20)에 통합되고, 카테터 배치 시술을 하는 동안, 및 아래에서 설명할 기재될 실시예에 따른 카테터 말단팁 위치를 재확인하는 동안 임상의에게 정보를 표시하는데 사용된다. 선택적으로, 디스플레이는 콘솔로부터 분리될 수 있다. 일 실시예에서, 콘솔 버튼 인터페이스(32) 및 프로브(40)에 포함된 버튼은 카테터 배치 시술 동안 시스템(10)의 기능을 제어하는데 이용될 수 있다. 그러므로 아래와 같이, 시스템 콘솔(20)의 단일 디스플레이(30)는 환자의 맥관 구조에 접근할 때 초음파 유도와, 환자의 심장 결절에 대한 카테터 말단팁 배치의 ECG-기반 확인뿐만 아니라, 카테터 말단팁 위치의 후속 확인을 위해 사용될 수 있다. 일 실시예로 디스플레이(30)는 LCD 장치이다.
상술한 바와 같이, 초음파 프로브(40)는 카테터(72)의 맥관 구조로의 삽입 준비시 정맥 같은 피하 혈관의 초음파("US") 기반 시각화와 관련하여 사용된다. 그러한 시각화는 환자의 맥관 구조에 {삽입 장소(73)를 통해} 카테터를 삽입하기 위한 실시간 초음파 유도를 제공하며, 일반적으로 그러한 도입과 관련된 문제, 예컨대 부주의에 의한 동맥 상처, 혈종, 기흉 등을 포함하는 문제의 감소를 돕는다.
소형의 프로브(40)는, 헤드가 예상 삽입 장소(73)에 근접한 환자의 피부에 대해 위치될 때 초음파 펄스를 발생시키고 환자의 신체에 의해 반사된 후에 그것의 에코(echo)를 수신하기 위한 피에조 전기 배열(piezoelectric array)을 수용하는 헤드를 포함한다. 프로브(40)는 시스템(10)의 제어를 위한 복수의 제어 버튼을 더 포함할 수 있고, 따라서 임상의는 카테터 배치 이전에 환자의 삽입 장소 이전에 설정된 살균 지역을 벗어날 필요 없이 시스템 기능을 제어할 수 있다.
이와 같이 일 실시예에서, 임상의는 적절한 삽입 장소를 결정하고 바늘 또는 유도자 등으로 그 후 카테터로 함께 맥관 접근을 하기 위해 시스템(10)의 초음파 방식을 사용한다. 그 후 임상의는 프로브(40)에 포함된 버튼의 버튼 누름을 통해 살균 지역을 벗어날 필요 없이 매끄럽게 ECG-기반 카테터 팁 유도 방식(아래에 기재)으로 전환할 수 있다. 이러한 방법으로, 시스템(10)은 임상의가 맥관 구조를 통해 목적지쪽으로 카테터(72)의 말단팁을 안내하는 것을 돕는다.
도 1은 프로브(40)가 버튼과 프로브 작동을 통제하기 위한 메모리 컨트롤러(42)와 버튼을 더 포함하는 것을 도시한다. 버튼과 메모리 컨트롤러(42)는 일 실시예에서 EEPROM같은 비휘발성 메모리를 포함할 수 있다. 버튼과 메모리 컨트롤러(42)는 프로브 피에조 전기 배열과의 인터페이싱용 피에조 입출력 부품(44A)과, 버튼 및 메모리 컨트롤러(42)와의 인터페이싱용 버튼 및 메모리 입출력 부품(44B)을 포함하는 콘솔(20)의 프로브 인터페이스(44)와 조작 가능한 통신을 한다.
언급한 바와 같이, 시스템(10)은 동방 결절("SA") 또는 환자(70) 심장의 다른 전기 임펄스 배출 결절에 대한 카테터 말단팁(76A)의 근접도 판단을 할 수 있는 기능을 포함하며, 따라서 결절에 인접한 원하는 장소에 카테터 말단팁을 정밀하게 위치시키는 강화된 능력을 제공한다. 또한, 본 명세서에서 “ECG” 또는 “ECG-기반 팁 확인"으로 불리는, 시스템(10)의 이러한 방식은 카테터 말단팁을 환자 맥관 구조 내의 원하는 장소에 위치시키기 위해 동방 결절로부터의 ECG 신호의 검출을 가능하게 한다. US와 ECG 방식은 본 시스템(10)에 매끄럽게 결합되고 카테터 배치를 보조하기 위해 함께 또는 개별적으로 사용될 수 있다. 게다가, 자기 요소 기반(magnetic element-based) 카테터 팁 장소 같은 다른 방식은 또한 시스템(10)에 포함될 수 있다. 일 실시예에서, 본 명세서에 기재된 ECG 방식은 US 또는 다른 방식의 포함 없이 독립형 시스템에 포함될 수 있음을 알 수 있다. 따라서, 본 명세서에 기재된 실시예의 배경은 예시적인 배경에 불과하다고 이해되고 본 개시를 한정하는 것으로 간주하지 않는다. 또한, 다른 ECG-기반 유도/모니터링 시스템이 아래에 더 기재될 말단팁 재확인 실시예와 관련하여 사용될 수 있음에 주목하라.
도 1과 도 2는 삽입 장소(73)를 통해 환자(70)에게 삽입되는 카테터(72)의 루멘에 제거 가능하게 미리 배치된 탐침(130)을 도시한다. 탐침(130)은 감지 부품 즉, 동방 결절에서 발생되는 ECG 신호를 감지하기 위한 말단부에 인접한 전극을 포함한다. 탐침(130)은 전단부로부터 연장되고 센서(50)에 조작 가능하게 접속되는 테더(tether; 134)를 포함한다. 간단히 말해, 탐침 테더(134)는 탐침(130)의 말단부에 포함된 ECG 전극에 의해 검출된 ECG 신호가 카테터의 전진 중에 센서(50)로 전달되는 것을 허용하는 도전 경로를 제공한다.
기준 및 접지 ECG 피부 전극(reference and ground ECG skin electrodes; 138)은 환자(70)의 피부 표면에 부착되고 센서(50)에 조작 가능하게 부착되어 시스템이 심장의 동방 결절의 전기적 활량과 관계없는 높은 레벨의 전기적 활량을 걸러 내는 것을 가능하게 하고, 이로써 ECG-기반 팁 확인 기능을 가능하게 한다. 환자 피부에 위치된 ECG 피부 전극(138)으로부터 수신된 기준 및 접지 신호와 함께 탐침 전극에 의해 감지된 ECG 신호는 환자의 가슴에 위치된 센서(50) 또는 시스템(10)의 지정된 다른 부품에 의해 수신된다. 센서(50) 및/또는 콘솔 프로세서(22)는 디스플레이(30)에 심전도 파형을 생성하기 위해 ECG 신호 데이터를 처리할 수 있다. 센서(50)가 ECG 신호 데이터를 처리하는 경우에 프로세서는 의도된 기능을 수행하기 위해 그 안에 포함된다. 콘솔(20)이 ECG 신호 데이터를 처리하면, 프로세서(22), 컨트롤러(24) 또는 다른 프로세서가 콘솔에서 데이터를 처리하기 위해 활용될 수 있다.
따라서, 카테터(72)가 환자 맥관 구조를 통해 전진함에 따라, 디스플레이(30)는 탐침(130)의 전극에 의해 검출된 환자 심장의 전기적 활량의 결과로 발생된 ECG 심전도 파형을 나타낸다. 더 상세한 사항으로, 파형의 P파 부분을 포함해서, 동방 결절의 ECG 전기적 활량은 탐침(130)의 전극에 의해 검출되고 센서(50)와 콘솔(20)로 전달된다. ECG 전기적 활량은 그 후 디스플레이(30)에 나타나도록 처리된다. 그 다음, 카테터를 위치시킨 임상의는 P파의 개형을 포함하는 ECG 데이터를 관찰한 후, 카테터(72)의 말단팁(76A)의 최적의 위치를 결정할 수 있고 예컨대 이는 일 실시예에서 동방 결절에 근접한다.
ECG 파형 및 그것의 P파는 탐침(130)의 전극이 환자 심장의 동방 결절에 대해 이동함에 따라 변할 수 있다. 예컨대, ECG 파형의 P파 진폭은 전극이 동방 결절에 접근함에 따라 일반적으로 증가하고 전극이 동방 결절로부터 멀어짐에 따라 일반적으로 감소한다. 언급한 바와 같이 일 실시예에서, 콘솔(20)은 탐침 전극에 의해 검출된 ECG 신호를 수신하고 처리하는데 필요한 프로세서(22) 같은 전자 부품을 포함한다. 다른 실시예에서, 센서(50)가 ECG 신호를 처리하기 위해 필수적인 전자 부품을 포함할 수 있다. 본 명세서에 기재된 카테터 배치 시스템 및 이것의 사용에 관한 더 자세한 사항이 "카테터의 맥관 내 배치에 관한 장치 및 디스플레이 방법"이라는 명칭으로 2009년 9월 10일 출원된 미국 특허 출원 공보 2010/0036227호에서 발견될 수 있으며, 그 전체가 참조로서 본 명세서에 통합된다. 물론, 상기의 ECG 기반 카테터 배치 시스템은 본 명세서에 개시된 실시예를 실시하기 위해 사용될 수 있는 ECG 모니터의 일례에 불과하다. 즉, 다른 ECG 기반 감시 및 배치 시스템이 또한 사용될 수 있다.
본 실시예의 탐침(130)의 전극은 ECG 신호가 검출되고 탐침 와이어를 통해 테더(134)와 센서(50)로 전송되도록 전도성 탐침 와이어의 말단부를 포함한다. 그러나 맥관 내 ECG 신호 검출을 위해 사용되는 전극은 다양한 방법으로 구성될 수 있음을 유의한다. 그와 같이, 본 명세서에 사용된 "전극"은 일반적으로 환자 심장으로부터의 ECG 신호의 검출을 위해 사용될 수 있는 어떤 구조든지 될 수 있다. 기재될 바와 같이, 다른 실시예에서의 전극은 다른 가능한 전극 구성들 중에서 카테터의 루멘에 배치된 전도성 용액의 기둥의 일 부분을 포함할 수 있다.
위에 더 기재된 바와 같이, 탐침 전극(들)이 맥관 구조 내에서 전진함에 따라 동방 결절에서 방출되어 검출되는 ECG 신호 변화를 감시하게 되면, 카테터를 위치시키는 임상의는 카테터(72)의 말단팁이 맥관 구조 내에 원하는 대로 위치되는 때를 결정할 수 있게 된다. 또한, 카테터 말단팁의 원하는 위치의 일례는 상대 정맥(SVC)의 하단 삼분의 일에서 그것의 배치를 포함한다. 카테터(72)의 배치가 완료된 후에, 탐침(130)은 카테터(72)의 루멘으로부터 제거되며 카테터는 초기 사용을 위해 준비된다. 카테터(72)의 말단팁(76A)이 환자 맥관 구조 내의 원하는 위치에 최초로 위치될 때 검출된 ECG 파형은 또한 본 명세서에서 제1 ECG 신호 프로파일로 불린다.
부주의로 말단팁의 잘못된 위치나 이동이 발생하지 않는 것을 보장하기 위해 카테터의 초기 배치 이후에 카테터 말단팁(76A)의 위치를 종종 재확인하는 것이 바람직하다. 결과적으로, 이는 카테터를 통해 환자에게 전달되는 약제나 다른 용액이 맥관 구조의 원하는 위치에 전달되는 것을 보장한다. 시스템(10) 또는 다른 적절한 ECG 모니터링 시스템이 적절한 카테터 말단팁 위치의 후기 배치 재확인에 사용될 수 있다.
일 실시예에서, 그러한 카테터 말단팁 배치의 재확인은 - 본 명세서에서 또한 제2 ECG 신호 프로파일로 불리는 - ECG 파형을 분석함으로써 달성되며, 이는 설치된 카테터의 말단팁 또는 그 근처에서, 적절히 위치된 전극을 통해 검출되며, 그 후 카테터(72)가 시스템(10)을 이용해 최초로 위치될 때 측정된 제1 ECG 프로파일과 제2 ECG 프로파일을 비교한다.
유치 카테터 말단팁에서 ECG 신호를 측정하여 제2 ECG 프로파일을 얻기 위해, 적절한 도전 경로가 카테터(72) 내에 있어서, 카테터 말단팁에 대한 ECG 신호가 검출되어 시스템(10) 또는 다른 적절한 ECG 모니터로 전달될 수 있도록 해야 한다. 일 실시예에서, 카테터 내에 임시로 배치된 전도성 와이어가 전도 매체로 사용되며, 그것의 말단부는 ECG 신호 검출용 전극으로 역할한다. 전도성 와이어는 루어 커넥터들(74C) 중 하나와 그것의 각각의 연장 다리(74B)를 통해, 그리고 말단에서는 카테터(72)의 루멘을 통해 삽입될 수 있다. 설치된 카테터(72)의 길이를 알고 있으므로, 와이어는 와이어의 말단이 카테터의 말단팁(76A)에 근접하거나 말단이 접할 때까지 전진한다.
카테터(72)의 전단부를 지나, 와이어가 이를 통해 연장되는 연장 다리(74B) 밖으로 연장되는 전도성 와이어의 전단부는 도 2의 탐침(130)과 테더(134)와 유사한 방식으로 시스템(10)에 조작 가능하게 연결된다. 이러한 구성은 동방 결절에서 방출된 ECG 신호, 즉 제2 ECG 프로파일이 전도성 와이어의 말단 또는 근처에서 검출되고 전도성 와이어를 통해 시스템(10)에 전달되는 것을 가능하게 하며, 이로써 임상의에게 현재 위치에서의 카테터(72)의 말단팁(76A)의 ECG 프로파일에 대해 알려준다.
언급한 바와 같이, 바로 위에서 설명한 대로 구성된 전도성 와이어는 도 2에 도시된 탐침(130)과 유사하다. 즉, 일 실시예에서 초기 카테터 배치에 이용된 탐침(130)은 그것을 카테터(72)의 루멘에 삽입하고, 도 2에 도시된 바와 같이 테더(134)를 통해 조작 가능하게 시스템(10)에 연결함으로써 초기 배치 이후 다시 카테터 말단팁 위치를 재확인하는데 이용될 수 있으며, 이로써 현재 위치에서의 카테터 말단팁의 제2 ECG 프로파일을 얻을 수 있도록 한다. 게다가, 다른 적절한 탐침이나 안내 와이어가 카테터 말단팁으로부터 시스템까지의 상술한 도전 경로를 제공하기 위해 사용될 수 있다.
도 3은 팁 위치 재확인을 위한 시스템(10)과, 유치 카테터 말단부(76A) 또는 그 근처의 전극 사이의 도전 경로를 제공하기 위한 다른 구성의 상세한 사항을 도시한다. 특히, 도전 경로는 그것의 말단팁(76A)으로 연장하도록 각각의 연장 다리(74B)와 카테터(72)의 루멘에 배치된 전도성 용액(200)을 포함한다. 전도성 용액(200)은 염분이나 다른 생체 적합하고 전기적으로 전도성인 용액을 포함한다. 그렇게 구성함으로써, 전도성 용액(200)은 카테터(72)의 말단팁(76A)에서 ECG 신호를 검출하기 위한 전극과 도전 경로의 일부로서 역할을 한다. 캡(202)은 각각 유체 충전식 연장 다리(74B)의 루어 커넥터(74C)에 연결된다.
전도성 용액(200) 뿐만 아니라, 도 3의 실시예의 도전 경로는 캡(202)을 지나 각각의 연장 다리(74B)를 통해 말단으로 연장하는 전도성 와이어(208)를 더 포함하며, 이로써 그 말단부(208B)는 전도성 용액에 담궈진다. 전단부(208A)에서 종결되는 전도성 와이어(208)의 전단부는 캡(202)으로부터 연장한다. 앨리게이터 클립(alligator clip; 210)이나 다른 적절한 전기 커넥터가 전도성 와이어(208)의 전단부에 부착된다. 클립(210)은, 도 2의 테더(134)의 연결 방식과 유사하게 시스템(10)의 센서(50)에 연결되는 테더(234)에 조작 가능하게 연결되며, 따라서 카테터(72)에 배치된 전도성 용액(200)의 기둥이 시스템에 조작 가능하게 연결되고 전도성 용액에 의해 검출된 ECG 신호가 시스템으로 전송될 수 있다. 이러한 방식으로, 맥관 구조 내의 카테터(72) 말단팁(76A)의 위치를 나타내는 제2 ECG 신호 프로파일이 얻어질 수 있다. 도 2와 도 3에 연관하여 기재된 것뿐만 아니라, 다른 실시예에서는 다른 도전 경로 구성이 사용될 수 있다. 따라서, 이러한 도전 경로 용액은 한정되지 않는 것으로 간주하여야 한다.
초기 카테터 말단팁 배치시 얻어진 제1 ECG 신호 프로파일과, 말단팁 위치의 재확인시 측정된 후속하는 제2 ECG 프로파일을 비교하기 위해, 초기 배치시의 제1 ECG 신호 프로파일을 저장하기 위한 저장 부품이 필수적이다. 일 실시예에서, 이는 시스템(10)이나 다른 적절한 ECG 모니터링 시스템을 카드 판독기/인코더(250)와 함께 설치함으로써 달성되며, 이 예는 도 4에서 콘솔(20)에 부착된 것으로 도시된다. 따라서, 시스템(10)을 이용하여 카테터(72)가 초기에 위치될 때, 환자 데이터 카드(254)는, 초기 배치시의 제1 ECG 신호 프로필을 포함하는 초기 카테터 배치에 관한 다양한 데이터를 데이터 카드의 자기 스트라이프(256)에 암호화시키고 저장하는 판독기/인코더(250)에 카드를 긁음으로써, 시스템(10)에 의해 암호화될 수 있다. 카드(254)는 그 후 환자에게 제공되거나 보호된다.
그 후, 이전에 위치된 카테터(72)(도 1)의 말단팁(76A)의 위치의 재확인이 요구될 때, 카테터는 카테터의 말단팁(76A)으로부터 시스템까지의 도전 경로를 제공하도록 도 2, 도 3과 관련하여 상술했던 구성 중 하나로 또는 다른 적절한 방법으로 시스템(10)에 조작 가능하게 연결된다. 그 후, 초기 카테터 배치시 암호화된 카드(254)가 판독되도록 시스템(10)의 판독기/인코더(250)에 긁는다. 이는 시스템(10)에 초기 배치시 카테터 말단팁의 제1 ECG 신호 프로파일을 제공한다. 예컨대, 초기 배치에서 카테터(72)의 말단부(76A)나 그 근처에서 전극에 의해 검출된 ECG 파형을 포함하는 제1 ECG 신호 프로파일이 시스템 콘솔(20)(도 1)의 디스플레이(30)에 나타나거나 또는 임상의에게 전달될 수 있다.
새로운 ECG 신호 측정이, 맥관 구조 내의 현재 카테터 말단팁 위치와 관련된 제2 ECG 신호 프로파일을 생성하기 위해, 카테터(72)의 말단팁(76A)이나 그 근처에 배치된 전극과, 전극을 시스템(10)과 상호 연결하는 적절한 도전 경로를 이용하여 이루어진다. 제1 ECG 신호 프로파일처럼 제2 ECG 신호 프로파일 또한 시스템 콘솔(20)의 디스플레이(30)에 나타날 수 있다. 두 개의 ECG 신호 프로파일은 카테터(72)의 말단팁(76A)이 원하지 않는 배치에 있는지 판단할 수 있도록 ECG 파형들을 서로 위에 놓음으로써 중첩될 수 있고, 몇몇의 적절한 방법(예컨대, P파 전압의 절대값의 측정)으로 비교될 수 있다. 만약 그렇다면, 카테터 말단팁(76A)을 적절하게 재위치시키기 위해 임상의가 적당한 시술을 할 수 있다. 잘못 위치되지 않은 경우에는 카테터(72)는 의도한 대로 이용될 수 있다. 다른 실시예에서 상기 과정의 구체적인 순서는 바뀔 수 있다. 예컨대 일 실시예에서, 시스템에 제1 ECG 신호 프로파일을 입력하기 전에 제2 ECG 신호 프로파일을 얻을 수 있다.
도 5는 초기 배치의 제1 신호 프로파일과 다른 데이터를 저장하고 접근할 수 있게 하는 다른 가능한 저장 부품을 도시하며, 분기(74A)같은 카테터(72)의 일부분에 RFID칩(270)이 탑재되어 있다(도 2 참조). 도 6에 도시된 바와 같이, 안테나(280)와, 관련 회로(282)를 포함하는 RFID 인코더/판독기(274)는 초기 배치에서의 카테터 말단팁(76A)의 위치와 관련된 제1 ECG 신호 프로파일을 카테터 RFID칩(270)에 암호화하고 저장할 수 있도록 시스템(10)이나 다른 적절한 ECG 모니터에 포함될 수 있다. 일 실시예에서, RFID칩(270)은 칩 자체의 고유 식별을 위한 읽기 전용 메모리와, 초기 배치에서의 제1 ECG 신호 프로파일을 저장하기 위해 RFID 인코더/판독기(274)에 의한 프로그래밍이 가능한 비휘발성 메모리를 모두 포함하는 필드 프로그래밍 가능한 칩이다.
제1 ECG 신호 프로파일뿐만 아니라, 환자 이름, 초기 배치 날짜와 장소, 절단 후의 카테터의 최종 길이, 이전의 전력 투입 기록, 크레아티닌 또는 다른 혈구 수치 등을 포함하는 다른 데이터도 RFID칩(270){또는 도 4의 카드(254)나 다른 적절한 저장 부품}에 저장될 수 있다. 일 실시예에서, 배치가 완료된 후 삽입 장소 외부에 남은 PICC 부분의 길이가 저장된다. 다른 실시예에서, 웹 포탈 정보가 유용한 정보나 다른 도움이 제공되는 웹사이트로 사용자를 안내하기 위해 저장될 수 있다. RFID칩(270)은 자동 또는 수동일 수 있다. 더 나아가, 시스템(10) 자체 내의 저장 장소와 ECG 신호 모니터가 WiFi나 다른 적절한 무선 프로토콜 등을 통해 프로파일에 무선으로 접근할 수 있는 원격의 떨어진 저장소를 포함하는 다른 저장 부품이 제1 및/또는 제2 ECG 신호 프로파일을 저장할 수 있다.
도 7은 일 실시예에서 카테터 말단팁 위치의 재확인 중에 시스템(10)의 디스플레이(30)에 나타나는 스크린샷(300)의 하나의 가능한 예를 도시한다. 도시한 바와 같이, 스크린샷(300)은 상술한 초기 카테터 배치시의 제1 ECG 신호 프로파일에 해당하는 파형(310A)과, 말단팁 배치의 재확인시의 제2 ECG 신호 프로파일에 해당하는 파형(310B)을 포함하는 ECG 파형(310)을 도시한다. 두 파형(310A, 310B)은 시스템(10)에 의해 수정될 수 있고 그들 사이의 비교가 이루어질 수 있도록 일 실시예에서 서로 중첩될 수 있다. 예컨대 일 실시예에서, 동방 결절에 대한 카테터 말단팁(76A)의 이동이 발생했는지 판단하기 위해, 초기 파형(310A)의 P파(312A)가 현재 파형(310B)의 P파(312B)와 비교될 수 있다.
스크린샷(300)의 우측에는 또한 환자, 카테터 종류, 카테터 길이 등의 부가적인 데이터(314)를 보여준다. 물론, 여기에 묘사된 ECG 신호와 다른 데이터는 하나 이상의 다양한 유형과 형식을 취할 수 있다. 즉, 데이터 내용은 당업자에 의해 요구나 필요에 따라 달라질 수 있다. 예컨대 일 실시예에서, 초기 카테터 배치 중의 P파 크기의 최고점과, 초기 배치 중의 최종 말단팁 배치를 위한 카테터 후퇴 후의 P파 크기가 팁의 재확인시 얻어진 비슷한 크기와 추후 비교하기 위해 저장된다.
따라서 일 실시예에 따르면, 환자 신체 내부의 카테터나 다른 유치 의료 장치의 위치의 재확인을 위한 방법이 개시된다. 본 방법은 환자의 ECG 신호를 이용해 환자 신체 내부에 의료 장치를 위치시키고, 이어서 의료 장치의 초기 배치 완료 후에 유치 의료 장치의 초기 위치와 관련된 제1 ECG 신호 프로파일을 저장하는 것을 포함한다. 언급한 바와 같이, 제1 ECG 신호 프로파일은 환자 카드, RFID칩, ECG 신호 데이터를 기록 및 출력하는 시스템 메모리 내부, 또는 다른 적절한 저장 부품에 저장될 수 있다. 본 방법은 의료 장치의 초기 배치 이후의 유치 의료 장치의 위치에 연관된 제2 ECG 신호 프로파일을 얻는 것과, 의료 장치의 초기 배치 이후에 유치 의료 장치의 이동이 있었는지 판단하기 위해 제1 ECG 신호 프로파일과 제2 ECG 신호 프로파일을 비교하는 것을 더 포함한다. 프로파일의 비교는 콘솔 디스플레이(30)에 나타난 파형을 임상의가 관찰하는 것으로 직접적으로 이루어지거나, 콘솔(20)의 프로세서(22)에 의해 실행 가능한 적절한 알고리즘에 의해 자동으로 시행될 수 있다.
본 발명의 실시예는 본 개시의 정신에서 벗어나지 않고 다른 구체적인 유형으로 실시될 수 있다. 기재된 실시예는 모든 경우에 도식적인 것으로만 고려되어야 하며 제한적으로 고려되어서는 안 된다. 그러므로, 본 실시예의 범위는 이전의 기재보다는 첨부된 청구항에 의해 정해진다. 청구항의 균등한 범위와 의미 내의 모든 수정은 그 범위에 포함된다.

Claims (29)

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  12. 환자 내부의 카테터의 위치를 재확인하기 위한 시스템이며,
    상기 카테터는 환자 심장의 ECG 신호 생성 결절 근처에 배치되고,
    상기 시스템은,
    제1 ECG 신호 프로파일을 획득하기 위한 하나 이상의 전극 - 제1 ECG 신호 프로파일은 최종 대상 목적지에서 카테터의 초기 배치가 완료된 후의 환자 내의 카테터의 말단팁의 초기 위치에 관한 것이며, 하나 이상의 전극은 환자 내의 카테터 말단팁의 다음 위치에 관한 제2 ECG 신호 프로파일도 획득함 - 과,
    적어도 제1 ECG 신호 프로파일을 저장하기 위한 저장 부품과,
    저장 부품으로부터 제1 ECG 신호 프로파일을 수신하고 제2 ECG 신호 프로파일도 수신하며, 카테터의 말단팁의 다음 위치가 최종 대상 목적지에서 카테터의 초기 배치가 완료된 후의 초기 위치와 다른지 판단할 수 있도록 제1 및 제2 ECG 신호 프로파일과 관련된 데이터를 전달하는 ECG 신호 모니터를 포함하는 카테터 위치 재확인 시스템.
  13. 제12항에 있어서, 제1 ECG 신호 프로파일을 획득하기 위한 하나 이상의 전극은 환자의 신체 내 카테터 내부에 포함되고, 상기 하나 이상의 전극은 도전 경로에 의해 조작 가능하게 ECG 신호 모니터에 연결되는 카테터 위치 재확인 시스템.
  14. 제13항에 있어서, 상기 하나 이상의 전극은 카테터의 루멘 내에 배치된 탐침을 포함하고, 상기 도전 경로는 하나 이상의 전극에 조작 가능하게 연결된 테터를 포함하는 카테터 위치 재확인 시스템.
  15. 제12항에 있어서, 상기 하나 이상의 전극과 도전 경로는 카테터의 루멘 내에 배치된 전도성 용액을 포함하는 카테터 위치 재확인 시스템.
  16. 제15항에 있어서, 전도성 용액 안에는 전도성 와이어가 부분적으로 배치되고, 전도성 와이어는 카테터로부터 연장되고 ECG 신호 모니터에 조작 가능하게 연결되는 카테터 위치 재확인 시스템.
  17. 제12항에 있어서, 상기 저장 부품은 카테터에 포함된 RFID칩을 포함하고, ECG 신호 모니터는 RFID칩의 제1 ECG 신호 프로파일을 암호화하고 판독하기 위한 RFID 인코더/판독기를 포함하는 카테터 위치 재확인 시스템.
  18. 제17항에 있어서, 상기 RFID칩은 필드 프로그래밍 가능한 칩인 카테터 위치 재확인 시스템.
  19. 제12항에 있어서, 상기 저장 부품은 카테터에 대해 원격으로 배치되는 카테터 위치 재확인 시스템.
  20. 제19항에 있어서, 상기 저장 부품은 프로그래밍 가능한 자기 스트라이프를 포함하는 카드를 포함하고, ECG 신호 모니터는 카드 인코더/판독기를 포함하는 카테터 위치 재확인 시스템.
  21. 제12항에 있어서, 상기 ECG 신호 모니터는 원격의 장소로부터 제1 ECG 신호 프로파일을 무선으로 수신하는 카테터 위치 재확인 시스템.
  22. 제12항에 있어서, 상기 제1 및 제2 ECG 신호 프로파일 중 적어도 하나는 배치 후 환자의 신체 외부에 남은 카테터 부분의 길이와, 추가적인 정보를 얻을 수 있는 웹 포탈 중 적어도 하나와 관련된 데이터를 포함하는 카테터 위치 재확인 시스템.
  23. 제12항에 있어서, 상기 ECG 신호 모니터는 환자 내부에 배치되는 하나 이상의 전극과, 환자의 피부에 배치되기 위한 두 개 이상의 전극을 포함하는 카테터 위치 재확인 시스템.
  24. 제12항에 있어서, 제1 전극은 제1 ECG 신호 프로파일을 획득하기 위해 사용되고, 제2 전극은 제2 ECG 신호 프로파일을 획득하기 위해 사용되는 카테터 위치 재확인 시스템.
  25. 삭제
  26. 삭제
  27. 삭제
  28. 삭제
  29. 삭제
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