KR101226542B1 - 2-부품 e-빔 발사 기구를 구비하는 관절화 수술용스테이플링 도구 - Google Patents
2-부품 e-빔 발사 기구를 구비하는 관절화 수술용스테이플링 도구 Download PDFInfo
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Abstract
복강경 및 내시경 임상 시술에 적합한 수술용 절개 및 스테이플링 도구는 앤빌에 의해 피벗식으로 대향된 세장형 채널의 엔드 이펙터 내에 조직을 클램핑한다. E-빔 발사 바아가 조직을 절개하여 절개부의 양 측면에 스테이플을 구동하도록 클램핑된 엔드 이펙터를 통해 원위측으로 이동한다. E-빔 발사 바아는 특히 엔드 이펙터를 이격시키도록 부적절한 조직량이 클램핑될 때 적절하게 형성된 폐쇄 스테이플을 보장하도록 세장형 채널로부터 앤빌을 확실하게 이격시킨다. 특히, 발사 바아의 상부핀은 앤빌 슬롯을 통해 길이방향으로 이동하고, 채널 슬롯은 최소 이격을 보장하도록 발사 바아의 중간핀과 하부 캡 사이에 포획된다. 두꺼운 원위부 및 얇은 근위부로부터 E-빔을 형성하는 것은 제조성을 향상시키고 이러한 관절화 수술용 도구에서의 사용을 용이하게 한다.
복강경, 내시경, 관절화 수술용 스테이플링 도구, 절개부, 앤빌 슬롯
Description
도 1은 개방의 비관절화 상태에서 수술용 스테이플링 및 절개를 위한 내시경 수술용 스테이플링 도구의 사시도.
도 2는 스테이플 채널에 포함된 교체 가능한 스테이플 카트리지의 우측 반부를 갖는 도 1의 수술용 스테이플링 도구의 개방 스테이플 적용 조립체의 좌측 전방 사시도.
도 3은 완전한 교체 가능한 스테이플 카트리지 및 대안의 비관절화 샤프트 구조를 갖는 도 2의 스테이플 적용 조립체의 전개 사시도.
도 4는 도 2의 스테이플 적용 조립체의 2-부품 나이프 및 발사 바아("E-빔")의 사시도.
도 5는 도 1의 스테이플 적용 조립체의 스테이플 카트리지의 웨지 슬레드의 사시도.
도 6은 도 2의 스테이플 적용 조립체의 중심선 6-6을 따른 종단면에서 취한 좌측 입면도.
도 7은 교체 가능한 스테이플 카트리지가 없고, 스테이플 채널의 부분이 2- 부품 나이프 및 발사 바아의 중간 핀에 근접하며, 스테이플 채널의 원위부가 없는 도 2의 개방 스테이플 적용 조립체의 사시도.
도 8은 스테이플 카트리지의 내부 스테이플 드라이버들 및 2-부품 나이프와 발사 바아의 부분들을 도시하는 도 2의 스테이플 적용 조립체의 라인 8-8을 따른 단면을 취한 정면 입면도.
도 9는 2-부품 나이프와 웨지 슬레드 사이에 중심 접촉점을 포함하도록 도 2의 폐쇄 스테이플 적용 조립체의 라인 6-6의 길이방향 축선을 따라 일반적으로 취하고 뿐만 아니라 스테이플 카트리지 내의 스테이플 및 스테이플 드라이브를 도시하도록 측방향으로 편위된 좌측 입면도.
도 10은 2-부품 나이프가 스테이플 카트리지 교체를 위해 통상적인 바와 같이 약간 수축된 도 9의 스테이플 적용 조립체의 상세 좌측 입면도.
도 11은 도 9에 도시된 구성에 대응하는 2-부품 나이프가 발사되기 시작하는 도 10의 스테이플 적용 조립체의 상세 좌측 입면도.
도 12는 2-부품 나이프 및 발사 바아가 원위측으로 발사된 후의 도 9의 폐쇄 스테이플 적용 조립체의 좌측 단면 입면도.
도 13은 2-부품 나이프의 스테이플 카트리지의 발사 및 수축 후의 도 12의 폐쇄 스테이플 적용 조립체의 좌측 단면 입면도.
도 14는 2-부품 나이프가 로크아웃 위치로 낙하되는 도 13의 스테이플 적용 조립체의 상세 좌측 단면 입면도.
도 15는 도 1의 수술용 스테이플링 도구의 관절화 조인트(가요성 네크)의 라 인 15-15를 따라 취한 상부 단면도.
도 16은 전기활성적 중합체(EAP) 플레이트 관절화 액추에이터 및 발사 바아용 EAP 지지 플레이트를 도시하는 도 15의 관절화 조인트의 라인 16-16을 따른 수직 단면을 취한 전방 입면도.
도 17은 관절화 후의 도 16의 관절화 조인트의 라인 15-15를 따른 상면도.
도 18은 도 15의 관절화 조인트의 사시도.
*도면의 주요 부분에 대한 부호의 설명*
10 : 수술용 스테이플링 도구 12 : 스페이플 적용 조립체
14 : 핸들 16 : 세장형 샤프트
18: 스테이플 채널 20 : 스테이플 카트리지
23 : 스테이플 24 : 스테이플 구멍
26 : 스테이플 형성 리세스 28 : 앤빌 하위면
30 : 회전 손잡이 32 : 관절화 조인트
34 : 관절화 제어 스위치 36 : EAP 작동기
38 : EAP 제어기 및 전원 40 : 폐쇄 트리거
42 : 피스톨 그립 44 : 발사 트리거
46 : 수축 레버 48 : 폐쇄 해제 버튼
70 : 샤프트 프레임 72 : 피벗 단부
74 : 근위 단부 76 : 폐쇄 특징부
78 : 폐쇄 튜브 90 : 2-부품 나이프 및 발사 바아
92 : 길이방향 발사 바아 슬롯 94 : 층상 테이퍼진 발사 바아
102 : E-빔 104 : 암형 수직 부착 개구
106 : 수형 부착 부재 110 : 상부핀
112 : 중간핀 114 : 하부핀 또는 푸트
116 : 첨예한 절삭 에지 118 : 상부 가이드
120 : 중간 가이드 122 : 조직 다단화 영역
124 : 단차형 중앙 부재 126 : 웨지 슬레드
130 : 확장 구멍 132 : 하부 트랙
133 : 좁은 슬롯 134 : 확장된 슬롯
136 : 하향 돌출부 138 : 상향 돌출부
140 : 측방향 바아 142 : 정사각형 개구
144 : 클립 스프링 150 : 앤빌 포켓
152 : 하향 개방 수직 앤빌 154 : 앤빌 내부 트랙
202 : 하향 개방 웨지 슬롯 204 : 웨지
206 : 웨지 스테이플 208 : 스테이플 드라이버 리세스
210 : 스테이플 구멍 214 : 스테이플 성형면
216 : 중앙 발사 리세스 218 : 수평부
220 : 스테이플 카트리지 트레이 222 : 스테이플 카트리지 본체
관련 출원들에 대한 상호 참조
본 출원은 2004년 7월 28일자로 출원된 발명의 명칭이 "전기 작동식 관절화 기구를 구비하는 수술용 도구"인 셀턴(Shelton)의 미국 가특허출원 제 60/591,694호의 이익을 청구한다. 본 출원은 그 개시 내용이 그대로 본원에 참조로 합체되어 있는 2003년 5월 20일 출원된 발명의 명칭이 "E-빔 발사 기구를 구비하는 수술용 스테이플링 도구"인 쉘턴의 미국 특허 출원 제 10/443,617호의 일부 계속 출원이다.
본 발명은 일반적으로 길이방향 구동 발사 부재에 의해 작동되는 엔드 이펙터(end effector)를 내시경 시술로 삽입하기에 적합한 수술용 도구에 관한 것이고, 더 구체적으로는 관절화 샤프트를 갖는 수술용 스테이플링 및 절개 기구에 관한 것이다.
내시경 수술용 도구는 더 소형의 절개가 수술후 회복 시간 및 합병증을 감소시키는 경향이 있기 때문에 전통적인 개방 수술 디바이스보다 종종 바람직하다. 따라서, 투관침의 캐뉼러를 통한 소정의 수술 부위로의 원위 엔드 이펙터의 정밀한 배치에 적합한 내시경 수술용 도구의 범위에 상당한 개발이 이루어지고 있다. 이들 원위 엔드 이펙터는 진단 또는 치료 효과를 성취하기 위해 다수의 방식으로(예를 들면, 내시경 절단기, 파지기, 절단기, 스테이플러, 클립 적용기, 접근 디바이스, 약물/유전자 치료 전달 디바이스 및 초음파, RF, 레이저 등을 사용하는 에너지 디바이스 등) 조직에 결합한다.
엔드 이펙터의 위치설정은 투관침에 의해 구속된다. 일반적으로 이들 내시경 수술용 도구는 임상의에 의해 조작되는 핸들부와 엔드 이펙터 사이에 기다란 샤프트를 포함한다. 이 긴 샤프트는 소정 깊이로의 삽입 및 샤프트의 길이방향 축선 둘레로의 회전을 가능하게 하며, 이에 의해 엔드 이펙터를 소정 정도로 위치설정한다. 투관침의 적절한 배치 및 예를 들면 다른 투관침을 통한 파지기의 사용에 의해, 종종 이 위치설정량이 충분하다. 미국 특허 제 5,465,895호에 설명된 바와 같은 수술용 스테이플링 및 절개 기구가 삽입 및 회전에 의해 엔드 이펙터를 성공적으로 위치설정하는 내시경 수술용 도구의 예이다.
더 최근에는, 그대로 본원에 참조로 합체되어 있는 2003년 5월 20일 출원된 발명의 명칭이 "E-빔 발사 기구를 구비하는 수술용 스테이플링 도구"인 쉘턴 등의 미국 특허 출원 제 10/443,617호에는 조직을 절개하고 스테이플을 작동하기 위한 개선된 "E-빔" 발사 바아가 설명되어 있다. 부가의 장점 중 일부는 약간 더 많은 또는 더 적은 조직이 최적의 스테이플 형성을 위해 클램핑되더라도 엔드 이펙터의 조들(jaws), 또는 더 구체적으로는 스테이플 적용 조립체를 확실하게 이격시키는 것을 포함한다. 더욱이, E-빔 발사 바아는 합체될 다수의 적합한 로크아웃을 가능하게 하는 방식으로 엔드 이펙터 및 스테이플 카트리지를 결합한다.
수술의 특성에 따라, 내시경 수술용 도구의 엔드 이펙터의 위치설정을 더욱 조절하는 것이 바람직할 수 있다. 특히, 기구의 샤프트의 길이방향 축선을 횡단하는 축에 엔드 이펙터를 배향하는 것이 종종 바람직하다. 기구 샤프트에 대한 엔드 이펙터의 횡단 이동은 통상적으로 "관절화(articulation)"라 칭한다. 이는 일반적으로 스테이플 적용 조립체에 바로 근위측에 연장된 샤프트에 배치되는 피벗(또는 관절화) 조인트에 의해 성취된다. 이는 외과 의사가 더 양호한 스테이플 라인의 배치 및 더 용이한 조직 조작 및 배향을 위해 양 측면에서 원격으로 스테이플 적용 조립체를 관절화하는 것을 허용한다. 이 관절화 위치설정은 기관의 후방과 같은 소정의 경우에 임상의가 더 용이하게 조직을 결합하는 것을 허용한다. 게다가, 관절화 위치설정은 유리하게는 기구 샤프트에 의해 차단되지 않고 엔드 이펙터의 후방에 내시경이 위치설정될 수 있게 한다.
수술용 스테이플링 및 절개 기구의 관절화로의 접근은 내시경 기구의 작은 직경 제한 내로의 엔드 이펙터의 발사 및 조직을 클램핑하기 위한 엔드 이펙터의 폐쇄의 제어와 함께 관절화의 제어를 일체화함으로써(즉, 스테이플링 및 절개) 복잡해지는 경향이 있다. 일반적으로, 3개의 제어 운동이 모두 길이방향 병진으로서 샤프트를 통해 전달된다. 예를 들면, 미국 특허 제 5,673,840호에는 실행 샤프트를 통해 두 개의 연결 로드 중 하나를 선택적으로 후방 견인함으로써 관절화된 아코디언형 관절화 기구("가요성 네크")가 개시되어 있고, 각각의 로드는 샤프트 중심선의 대향 측면에 각각 편위된다. 연결 로드는 일련의 개별 위치를 통해 래칫 결합된다.
관절화 기구의 길이방향 제어의 다른 예는 관절화 링크의 압박 또는 견인 길이방향 병진이 각각의 측면으로의 관절화를 실행하도록 캠밍 피벗으로부터 편위된 관절화 링크를 포함하는 미국 특허 제 5,865,361호이다. 유사하게, 미국 특허 제 5,797,537호에는 관절화를 실행하도록 샤프트를 통과하는 유사한 로드가 개시되어 있다.
그 개시 내용이 그대로 본원에 참조로 합체되어 있는 발명의 명칭이 "길이방향 축선 둘레로 회전하는 관절화 기구를 구비하는 수술용 도구"인 프레데릭 이. 쉘턴 4세(Frederick E. Shelton IV)의 계류중인 공동 소유의 미국 특허 출원 제 10/615,973호에서, 회전 운동이 길이방향 운동의 대안으로서 관절 운동을 전달하는데 사용된다.
그 개시 내용이 이미 그대로 본원에 참조로 합체되어 있는 2003년 5월 20일 출원된 발명의 명칭이 "E-빔 발사 기구를 구비하는 수술용 스테이플링 도구"인 미국 특허 출원 제 10/443,617호에서, 복강경 및 내시경 임상 시술에 적합한 수술용 절개 및 스테이플링 도구가 앤빌에 의해 피벗식으로 대향된 세장형 채널의 엔드 이펙터 내에 조직을 클램핑한다. E-빔 발사 바아는 조직을 절개하고 절개부의 각각의 측면으로 스테이플을 구동하기 위해 클램핑된 엔드 이펙터를 통해 원위측으로 이동한다. E-빔 발사 바아는, 특히 엔드 이펙터를 이격하기에 부적절한 조직의 양이 클램핑될 때 폐쇄 스테이플이 적절하게 형성되는 것을 보장하도록 세장형 채널로부터 앤빌을 확실하게 이격한다. 특히, 발사 바아의 상부핀은 앤빌 슬롯을 통해 길이방향으로 이동하고, 채널 슬롯은 최소 이격을 보장하도록 발사 바아의 중간핀과 하부캡 사이에 포획된다. 이 E-빔 발사 바아는 다수의 장점을 갖지만, 부가의 특징이 제조성을 향상시키고 치수 편차를 최소화하기 위해 바람직하다.
따라서, 엔드 이펙터의 클램핑된 조들 사이의 적절한 이격을 유리하게 보장하고 그 샤프트의 관절화를 촉진하는 발사 바아를 구비한 수술용 도구에 대한 상당한 요구가 존재한다.
본 발명은 수술용 스테이플링 및 절개 기구의 엔드 이펙터를 확실하게 수직으로 이격하는 발사 기구를 제공함으로써 종래의 상술한 및 다른 결점을 극복한다. 따라서, 기구는 너무 적은 조직이 엔드 이펙터에 클램핑되는 경우에도 적절한 스테이플링을 성취하도록 적절한 이격을 구조적으로 보장한다. 절삭 에지를 포함하는 E-빔 내로의 이들 특징부의 일체 형성은 E-빔이 절개 및 스테이플링 조립체와 같은 엔드 이펙터를 통해 발사될 때 일정한 이격 및 성능을 실현한다. 또한, E-빔으로의 개별의 얇은 발사 바아의 근위측 부착은 감소된 단면적 및 관절 평면에서의 굴곡 능력이 요구되는 관절화 수술용 도구에서의 사용을 향상시킨다.
일 양태에서, 수술용 도구는 실행부를 작동시키는 발사 운동을 생성하도록 작동 가능한 핸들부를 포함한다. 이 실행부는 피벗식으로 부착된 앤빌에 의해 대향된 스테이플 카트리지를 수용하는 세장형 채널을 갖는다. 발사 디바이스는 세장형 채널과 앤빌 사이에 길이방향으로 수용되는 원위측 배치 절삭 에지, 앤빌 채널에 결합 가능한 상부 부재, 채널 슬롯과 결합하는 하부 부재 및 스테이플 카트리지에 일체인 웨지 슬레드를 작동시키도록 동작 가능한 중간 부재를 포함한다. 중간 부재는 엔드 이펙터의 압착에 유리하게 대항하며, 그렇지만 너무 작은 양의 조직이 클램핑될 때에라도 적절한 스테이플 형성을 보장한다. 이들 이격 및 절삭 특징부는 관절화를 위한 가요성이 E-빔에 부착된 얇은 발사 바아에 의해 제공되는 동안 E-빔 내에 유리하게 형성된다.
본 발명의 상기 및 다른 목적은 첨부 도면 및 그의 설명으로부터 명백해질 것이다.
본 명세서의 부분을 구성하고 명세서에 합체되며 본 발명의 실시예를 예시하는 첨부 도면과 함께 상술한 본 발명의 일반적인 설명 및 이하에 제공되는 실시예의 상세한 설명은 본 발명의 원리를 설명하는 역할을 한다.
도 1 내지 도 3에서, 수술용 스테이플링 도구(10)는 세장형 샤프트(16)에 의해 핸들(14)(도 2)로부터 이격된 스테이플 적용 조립체(12)로서 도시된 엔드 이펙터를 그 원위 단부에 갖는다. 스테이플 적용 조립체(12)는 교체 가능한 스테이플 카트리지(20)를 수용하기 위한 스테이플 채널(18)을 포함한다. 스테이플 채널(18)에 피벗식으로 부착된 앤빌은 스테이플 카트리지(20)에 조직을 클램핑하고 앤빌 하위면(28)의 스테이플 형성 리세스(26)(도 6)에 대해 스테이플 카트리지(20)의 스테이플 구멍(24)으로부터 구동된 스테이플(23)(도 3)을 폐쇄 형상으로 변형하는 기능을 한다. 스테이플 적용 조립체(12)가 폐쇄될 때, 그 단면적 뿐만 아니라 세장형 샤프트(16)는 투관침(도시 생략)의 캐뉼러를 통해서와 같이 소형 수술용 개구를 통한 삽입에 적합하다.
도 1을 특히 참조하면, 스테이플 적용 조립체(12)의 정확한 배치 및 배향이 핸들(14) 상의 제어부에 의해 촉진된다. 특히, 회전 손잡이(30)는 그 길이방향 축선 둘레로의 샤프트(16)의 회전 및 따라서 스테이플 적용 조립체(12)의 회전을 초래한다. 부가의 위치설정이 샤프트(16)의 길이방향 축선으로부터 원호형으로 스테이플 적용 조립체(12)를 피벗하는 샤프트(16) 내의 관절화 조인트(32)에서 이용 가능하고, 이에 의해 기관 후방의 배치를 허용하거나 또는 내시경(도시 생략)과 같은 다른 기구를 스테이플 적용 조립체(12) 후방에 배향시키는 것을 허용한다. 이 관절화는 핸들(14) 내에 포함된 전원(38) 및 EAP 제어기에 의해 급전되는 전기활성적 중합체(EAP)로 관절화 조인트(32)로의 전기 신호를 전송하는 핸들(14) 상의 관절화 제어 스위치(34)에 의해 유리하게 실행된다.
스테이플 적용 조립체(12) 내의 조직으로 위치설정되면, 외과 의사는 피스톨 파지부(42)를 향해 근위측으로 폐쇄 트리거(40)를 견인함으로써 앤빌(22)을 폐쇄한다. 이와 같이 클램핑되면, 외과 의사는 더 원위측에 존재하는 발사 트리거(44)를 파지하여, 소정의 적용에서는 하나의 단일 발사 스트로크에서 및 다른 적용에서는 다중 발사 스트로크에 의해 성취되는 스테이플 적용 조립체(12)의 발사를 실행하도록 후방 견인된다. 발사는 그 사이의 조직을 절개하면서 적어도 두 열의 스테이플의 동시 스테이플링을 성취한다.
발사 부품의 수축은 완전 이동시에 자동으로 초기화될 수 있다. 대안적으로, 수축 레버(46)가 수축을 실행하도록 후미로 견인될 수 있다. 발사 부품이 수축된 상태로, 피스톨 파지부(42)를 향해 후미로 폐쇄 트리거(40)를 약간 견인하고 폐쇄 해제 버튼(48)을 압박하고 이어서 폐쇄 트리거(40)를 해제하여 이에 의해 스테이플 적용 조립체(12)로부터 절개 조직의 두 개의 스테이플된 단부를 해제함으로써 외과 의사에 의해 스테이플 적용 조립체(12)가 분리되어 개방된다.
스테이플 적용 조립체
관절화 조인트(32)가 도 1에 도시되었지만, 명료화를 위해 및 대안 적용으로서 도 2 내지 도 14의 수술용 스테이플링 도구는 관절화 조인트(32)를 생략한다. 그러나, 본 발명의 양태는 도 15 내지 도 18을 참조하여 이하에 설명되는 바와 같이 관절화에 대해 특정 장점을 갖는다.
도 1 내지 도 3에서, 스테이플 적용 조립체(12)는 조직 상의 클램핑의 기능을 성취하여 샤프트 프레임(70)의 상부로 샤프트(16)를 길이방향으로 하강 전달하는 두 개의 개별 운동에 의해 스테이플을 구동하고 조직을 절개한다. 이 샤프트 프레임(70)은 핸들(14)에 근위측에서 부착되고 회전 손잡이(30)와 회전가능하게 커플링된다. 도 1의 수술용 스테이플링 및 절개 기구(10)의 예시적인 다중 스트로크 핸들(14)은 본원에 설명된 바와 같은 부가의 특징 및 변형을 가지며 그 개시 내용이 그대로 본원에 참조로 합체되어 있는 발명의 명칭이 "다중 스트로크 발사 위치 지시기 및 수축 기구를 구비하는 수술용 스테이플링 도구"인 스웨이즈(Swayze) 및 쉘턴의 계류중인 공동 소유의 미국 특허 출원 제 10/374,026호에 더욱 상세히 설명되어 있다. 다중 스트로크 핸들(14)은 긴 거리에 걸쳐 높은 발사력을 갖는 적용을 유리하게 지원하지만, 본 발명에 일치하는 적용은 그 개시 내용이 그대로 본원에 참조로 합체되어 있는 발명의 명칭이 "별도의 개별 폐쇄 및 발사 시스템을 갖는 수술용 스테이플링 도구"인 프레데릭 이. 쉘턴 4세, 마이클 이. 세처(Michael E. Setser) 및 브라이언 제이. 헤멜간(Brian J. Hemmelgarn)의 계류중인 공동 소유의 미국 특허 출원 제 10/441,632호에 설명된 바와 같은 단일 발사 스트로크를 구비할 수 있다.
도 3을 특히 참조하면, 샤프트 프레임(70)의 원위 단부가 스테이플 채널(18)에 부착된다. 앤빌(22)은 샤프트 프레임(70)으로의 그의 결합에 대한 바로 원위측에서 스테이플 채널(18)의 근위 단부(74) 내에 피벗식으로 수용된 근위 피벗 단부(72)를 갖는다. 앤빌(22)의 피벗 단부(72)는 근위측에 그러나 스테이플 채널(18)에 의한 그의 피벗식 부착에 대한 원위측에 폐쇄 특징부(76)를 포함한다. 따라서, 그의 원위 단부가 이 폐쇄 특징부(76)와 결합하는 편자형 개구(horseshoe aperture)를 포함하는 폐쇄 튜브(78)는 폐쇄 트리거(40)에 응답하여 근위측 길이방향 운동 중의 앤빌(22)에 대한 개방 운동 샤프트 프레임(70) 상에 활주하는 폐쇄 튜브(78)의 길이방향 운동 중의 앤빌(22)에 대한 폐쇄 운동을 선택적으로 부여한다.
샤프트 프레임(70)은 핸들(14)로부터 길이방향 왕복형 2-부품 나이프 및 발사 바아(90)를 통해 발사 운동을 초래하고 안내한다. 특히, 샤프트 프레임(70)은 2-부품 나이프 및 발사 바아(90), 특히 층상 테이퍼진 발사 바아(94)의 근위부를 수용하는 길이방향 발사 바아 슬롯(92)을 포함한다. 층상 테이퍼진 발사 바아(94)는 중실 발사 바아 또는 도 2 내지 도 14에 도시된 바와 같은 관절화 조인트를 통과하도록 의도되지 않는 적용에서는 다른 재료로 대체될 수 있다는 것을 이해해야 한다.
E-빔(102)은 별도의 폐쇄 및 발사 뿐만 아니라 발사 중의 세장형 스테이플 채널(18)로부터의 앤빌(22)의 이격을 촉진하는 2-부품 나이프 및 발사 바아(90)의 원위부이다. 특히 도 3 내지 도 4를 참조하면, 납땜 또는 접착과 같은 임의의 부착 처리에 부가하여, 나이프 및 발사 바아(90)는 층상 테이퍼진 발사 바아(94)에 의해 원위측에 제공된 대응 수형 부착 부재(106)를 수용하는 E-빔(102) 내에 근위측에 형성된 암형 수직 부착 개구(104)로 형성되어, 각각의 부분이 이들의 개별 기능(예를 들면, 강도, 가요성, 마찰)에 적합한 선택된 재료 및 프로세스로 형성될 수 있게 한다. E-빔(102)은 한 쌍의 상부핀(110), 한 쌍의 중간핀(112) 및 하부핀 또는 푸트부(foot)(114)를 형성하기 위한 적합한 재료 특성 뿐만 아니라 첨예한 절삭 에지(116)를 획득할 수 있는 재료로 유리하게 형성될 수 있다. 게다가, 절삭 에지(116)의 수직 단부 각각을 브래킷하는 일체로 형성된 근위측 돌출 상부 가이드(118) 및 중간 가이드(120)는 절개되기 전에 첨예한 절삭 에지(116)를 향해 조직을 안내하는 것을 도와주는 조직 다단화 영역(122)을 더 형성한다. 중간 가이드(120)는 또한 이하에 더 상세히 설명하는 바와 같이 스테이플 적용 조립체(12)에 의한 스테이플 형성을 실행하는 웨지 슬레드(wedge sled)(126)(도 5)의 단차형 중앙 부재(124)를 접함으로써 스테이플 적용 장치(12)를 결합하고 발사하는 기능을 한다.
이들 특징부[예를 들면, 상부핀(110), 중간핀(112) 및 하부 푸트부(114)]를 E-빔(102)과 일체로 형성하는 것은 복수의 부분으로부터 조립되는 것과 비교할 때 서로에 대해 더 긴밀한 공차로 제조하는 것을 촉진하여, 스테이플 적용 조립체(12)의 다양한 로크아웃 특징부와의 발사 및/또는 유효한 상호 작용 중에 소정의 작업을 보장한다.
도 6 내지 도 7에서, 수술용 스테이플링 도구(10)는 E-빔(102)이 완전히 수축된 상태로 개방되어 도시되어 있다. 조립 중에, E-빔(102)의 하부 푸트부(114)는 스테이플 채널(18) 내의 확장 구멍(130)을 통해 낙하되고 E-빔(102)은 이어서 E-빔(102)이 스테이플 채널(18) 내에 형성된 하부 트랙(132)을 따라 원위측으로 활주하도록 전진한다. 특히, 하부 트랙(132)은 좁은 슬롯(133)을 포함하며, 이 좁은 슬롯은 스테이플 채널(18)의 하부면 상의 확장된 슬롯(134)으로서 개방되며, 도 7 및 도 8에 특별히 도시된 바와 같이 확장 구멍(130)과 연통하는 측방향 단면이 반전 T-자 모양을 형성한다. 조립되면, 층상 테이퍼진 발사 바아(94)에 근위측에서 커플링된 부품은 분리를 허용하도록 하부 푸트부(114)가 확장 구멍(130)으로 재차 근위측으로 이동하는 것을 허용한다.
도 9에서, 층상 테이퍼진 발사 바아(94)는 투관침을 통한 스테이플 적용 조립체(12)의 삽입을 촉진한다. 특히, 더 원위측의 하향 돌출부(136)는 완전히 수축될 때 E-빔(102)을 상승시킨다. 이는 스테이플 채널(18)에 있는 확장 구멍(130)의 근위측 에지 상에서 하향 돌출부가 상향으로 캠밍하게 되는 소정 지점에 하향 돌출부(136)가 배치됨으로써 성취된다.
도 10에서, 층상 테이퍼진 발사 바아(94)는 또한 발사 이동의 초기 부분 동안에 샤프트 프레임(70)에 의해 하향으로 압박되는 더 근위측의 상향 돌출부(138)를 포함함으로써 스테이플 채널(18) 내로 합체될 수 있는 특정 로크아웃 특징부의 동작을 향상시킨다. 특히, 측방향 바아(140)는 샤프트 프레임(70)(도 3)의 한 쌍의 정사각형 개구(142) 사이에 형성된다. 측방향 바아(140)를 에워싸는 클립 스프링(144)이 길이방향 발사 바아 슬롯(92)의 외부로 원위측으로 돌출하는 층상 테이퍼진 발사 바아(94)의 부분을 하향으로 압박하고, 이는 적절한 때에 특정의 유리한 로크아웃 특징부가 결합되는 것을 보장한다. 이 압박은 상향 돌출부(138)가 클립 스프링(144)에 접촉할 때 발사 이동하는 그 부분에만 더 현저하게 나타나거나 한정된다.
도 6 내지 도 7에서, E-빔(102)은 앤빌(22)의 피벗 근위 단부에 인접한 앤빌 포켓(150) 내에 존재하는 그의 상부핀(110)에 의해 수축된다. 하향 개방 수직 앤빌 슬롯(152)(도 2)은 이들이 도 9 내지 도 10에 도시된 바와 같이 발사 동안에 원위측으로 전진하여 스테이플 채널(18)로부터 앤빌(22)을 확실하게 이격할 때 E-빔(102)의 상부핀(110)을 포획하는 앤빌 내부 트랙(154) 내로 앤빌(22)에서 측방향으로 확장한다. 따라서, E-빔(102)이 수축된 상태로, 외과 의사는 스테이플링 및 절개를 위해 내부에 포획된 조직의 배치 및 배향이 만족될 때까지 스테이플 적용 조립체(12)를 반복하여 개방 및 폐쇄할 수 있고, 또한 E-빔(102)은 감소된 직경 및 대응하여 감소된 강성의 스테이플 적용 조립체(12)에서도 조직의 적절한 위치설정을 지원한다.
도 2, 도 3, 도 5, 도 6 및 도 8 내지 도 14에서, 스테이플 적용 조립체(12)는 웨지 슬레드(126)를 포함하는 교체 가능한 스테이플 카트리지(20)로 도시되어 있다. 길이방향 정렬되고 평행한 복수의 하향 개방 웨지 슬롯(202)(도 8)이 웨지 슬레드(126)에 일체인 각각의 웨지(204)를 수용한다. 도 8 내지 도 10에서, 따라서 웨지 슬레드(126)는 스테이플 드라이버 리세스(208) 내에서 수직으로 활주 가능한 복수의 스테이플 드라이버(206)를 상향으로 캠밍한다. 이 예시적인 버전에서, 각각의 스테이플 드라이버(206)는 각각이 앤빌(22)의 스테이플 성형면(214)(도 10)에 대해 상부에 놓인 스테이플(23)을 변형시키고 상향으로 강제되도록 각각의 스테이플 구멍(210)으로 상향으로 병진하는 두 개의 수직 갈퀴부(prong)를 포함한다. 스테이플 채널(18)에 근위측에서 스테이플 카트리지(20) 내에 형성된 중앙 발사 리세스(216)(도 3)는 웨지 슬레드(126)의 저부의 수평부(218) 뿐만 아니라 E-빔(102)의 중간핀(112)의 통과를 허용한다. 구체적으로, 스테이플 카트리지 트레이(220)(도 3, 도 8)는 내부에 형성된 스테이플 드라이버 리세스(208), 스테이플 구멍(210) 및 중앙 발사 리세스(216)를 갖는 중합체 스테이플 카트리지 본체(222)에 부착되어 그 하부에 놓인다. 따라서 스테이플(23)이 양 측면에 형성될 때, 첨예한 절삭 에지(116)가 수직 관통 슬롯(23)으로 진입하여 그의 가장 원위 단부를 제외하고 스테이플 카트리지(20)의 길이방향 축선을 통과한다.
스테이플 적용 조립체(12)의 발사는 도 10에 도시된 바와 같이, 하향 돌출부(136)가 E-빔(102) 상에서 상향 및 후미로 중간 가이드(120)를 캠밍할 때까지 2-부품 나이프 및 발사 바아(90)가 근위측으로 견인되어, 앤빌(22)이 도 2 및 도 6에 도시된 바와 같이 개방될 때 스테이플 카트리지(20)가 스테이플 채널(18) 내에 삽입되는 것을 허용하는 것에서 시작된다.
도 11에서, 2-부품 나이프 및 발사 바아(90)가 작은 거리로 원위측으로 전진되고, 층상 테이퍼진 발사 바아(94)의 상향 돌출부(138)를 클립 스프링(144)이 압박하는 상태에서 하부 트랙(132)의 확장 구멍(130) 내로 하향 돌출부(136)가 낙하하는 것을 허용한다. 중간 가이드(120)는 웨지 슬레드(126)의 단차형 중앙 부재(124)에 놓임으로써 부가의 하향 회전을 방지하고, 따라서 E-빔의 중간핀(112)을 중앙 발사 리세스(216) 내에 유지한다.
도 12에서, 2-부품 나이프 및 발사 바아(90)가 원위측으로 발사되어, 스테이플 카트리지(20)와 앤빌(22) 사이에 클램핑된 조직(242)을 첨예한 절삭 에지(116)로 절개하면서 스테이플(23)의 형성을 초래하도록 웨지 슬레드(126)를 전진시킨다. 그 후에, 도 13에서, 2-부품 나이프 및 발사 바아(90)가 수축되어, 웨지 슬레드(126)를 원위측으로 위치시킨 채로 남겨둔다.
도 14에서, 중간핀(112)은 스테이플 채널(18)(또한 도 7, 도 10 참조) 내에 형성된 로크아웃 리세스(240) 내로 하향 병진하는 것이 허용된다. 따라서, 작업자는 웨지 슬레드(126)(도 14에는 도시 생략)가 원위측에 위치될 때[즉, 스테이플 카트리지(20)를 누락시키거나 또는 스테이플 카트리지(20)를 소비하여서] 중간핀(112)이 로크아웃 리세스(240)의 원위 에지에 부딪치는 것을 촉각으로 알게 된다.
도 1에서, 관절화 조인트(32)는 2-부품 나이프 및 발사 바아(90)의 가요성 강도로부터 유리하게 장점을 갖는 것으로 도시되었다. 도 15 내지 도 18에서, 관절화 조인트(32)는 관절화 평면에서의 관절화를 허용하는 원호형 리세스(304)들의 측방향 대칭 쌍을 갖는 척주체(302)에 의해 형성된 가요성 네크 조인트(300)로서 도시되어 있다. 일반적으로 각각의 측방향 측면(306, 308)을 길이방향으로 통과하는 제어 로드들(도시 생략)을 선택적으로 이동시킴으로써 각각의 측방향 측면(306, 308)을 동시에 압축하고 팽창하는 것이 공지되어 있다. 그러나, 도시된 EAP 플레이트 액추에이터들(310, 312)은 한편 또는 양쪽 측방향으로 강한 편향이 가능하다.
척주체(302)를 통해 길이방향으로 형성된 중앙 통로(320)(도 16)는 층상 테이퍼진 발사 바아(94)의 좌굴 및 바인딩을 방지하는 한 쌍의 지지 플레이트(322, 324)를 수용한다. 예시적인 버전에서, 각각의 지지 플레이트(322, 324)는 관절화 중에 반경방향 거리의 변화를 수용하기 위해 근위 고정 단부(326)(도 15) 및 활주 단부(328)를 갖는다. 더 얇은 두께의 발사 바아(94)의 구비가 따라서 지원된다.
본 발명을 다수의 실시예의 설명에 의해 예시하였고 예시적인 실시예가 상당히 상세하게 설명되었지만, 본 출원인의 의도는 이러한 상세로 첨부된 청구범위의 범주를 제한하거나 임의의 방식으로 한정하려는 것은 아니다. 부가의 장점 및 수정이 당 기술 분야의 숙련자들에게 즉시 명백할 것이다.
예를 들면 스테이플 카트리지에 일체인 웨지 슬레드를 갖는 것이 다수의 장점이 있지만, 본 발명의 양태와 일치하는 소정의 적용에서, 웨지 슬레드는 E-빔 대신에 일체형일 수 있다. 예로서, 스테이플 카트리지 자체보다는 오히려 전체 엔드 이펙터가 교체될 수도 있다.
Claims (20)
- 수술용 도구로서,발사 운동을 생성하도록 작동 가능한 핸들부, 및상기 핸들부로부터의 발사 운동에 응답하는 실행부를 포함하고,상기 실행부는,상기 핸들부에 커플링되고 채널 슬롯을 포함하는 세장형 채널,상기 세장형 채널에 의해 수용되고 스테이플을 지지하는 드라이버를 상향 캠밍을 위해 정렬된 근위측으로 위치설정된 웨지(wedge) 부재를 구비하는 스테이플 카트리지,상기 세장형 채널에 피벗식으로 커플링되고 앤빌 채널을 포함하는 앤빌,상기 세장형 채널과 상기 앤빌 사이에 길이방향으로 수용된 원위측 배치 절삭 에지, 상기 앤빌 채널에 결합 가능한 상부 부재, 상기 채널 슬롯과 결합하는 하부 부재, 및 상기 스테이플 카트리지의 상기 웨지 부재를 원위측으로 병진함으로써 상기 스테이플 카트리지를 작동하도록 작동 가능한 중간 부재를 포함하고, 스테이플 형성을 위한 간격을 그 사이에 제공하도록 길이방향 발사 이동 동안에 상기 세장형 채널과 상기 앤빌 양자에 형상 끼워 맞춤으로 결합하는 발사 디바이스,상기 세장형 채널에 근위측으로 커플링된 관절화 조인트, 및상기 핸들부로부터 상기 관절화 조인트를 통해 발사 운동을 전달하기 위해 상기 발사 디바이스에 근위측으로 부착된 얇은 발사 스트립을 포함하는, 수술용 도구.
- 제 1 항에 있어서, 상기 앤빌은 상기 스테이플 카트리지의 작동 동안에 상기 발사 디바이스가 상기 앤빌과 상기 세장형 채널 사이를 확실하게 이격하는 것을 지원하도록 각각의 원위 단부에서 내향으로 편의된 세장형 채널로의 피벗 부착부를 형성하는, 수술용 도구.
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US10/955,042 US7380696B2 (en) | 2003-05-20 | 2004-09-30 | Articulating surgical stapling instrument incorporating a two-piece E-beam firing mechanism |
US10/955,042 | 2004-09-30 |
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- 2005-07-27 RU RU2005123960/14A patent/RU2435532C2/ru not_active IP Right Cessation
- 2005-07-27 PL PL10177662.3T patent/PL2258280T3/pl unknown
- 2005-07-27 AT AT05254683T patent/ATE489041T1/de not_active IP Right Cessation
- 2005-07-27 DE DE602005024899T patent/DE602005024899D1/de active Active
- 2005-07-27 JP JP2005216951A patent/JP4841886B2/ja active Active
- 2005-07-27 BR BRPI0503062A patent/BRPI0503062B8/pt active IP Right Grant
- 2005-07-27 EP EP10177662.3A patent/EP2258280B1/en active Active
- 2005-07-28 MX MXPA05008049A patent/MXPA05008049A/es not_active Application Discontinuation
- 2005-07-28 KR KR1020050068944A patent/KR101226542B1/ko active IP Right Grant
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Also Published As
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US7380696B2 (en) | 2008-06-03 |
EP2258280A1 (en) | 2010-12-08 |
KR20060048865A (ko) | 2006-05-18 |
EP1621139B1 (en) | 2010-11-24 |
AU2005203191A1 (en) | 2006-02-16 |
DE602005024899D1 (de) | 2011-01-05 |
US20050263562A1 (en) | 2005-12-01 |
EP1621139A3 (en) | 2008-04-23 |
PL2258280T3 (pl) | 2016-12-30 |
EP2258280B1 (en) | 2016-07-06 |
RU2005123960A (ru) | 2007-02-10 |
ATE489041T1 (de) | 2010-12-15 |
RU2435532C2 (ru) | 2011-12-10 |
EP1621139A2 (en) | 2006-02-01 |
CA2513479A1 (en) | 2006-01-28 |
JP2006034975A (ja) | 2006-02-09 |
BRPI0503062B1 (pt) | 2016-12-06 |
CA2513479C (en) | 2013-02-26 |
BRPI0503062B8 (pt) | 2021-06-22 |
AU2005203191B2 (en) | 2011-06-09 |
JP4841886B2 (ja) | 2011-12-21 |
MXPA05008049A (es) | 2006-02-10 |
BRPI0503062A (pt) | 2006-03-14 |
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