KR101356585B1 - 상이하게 형성되는 스테이플 높이를 갖는 스테이플을형성하기 위한 스테이플 카트리지 - Google Patents
상이하게 형성되는 스테이플 높이를 갖는 스테이플을형성하기 위한 스테이플 카트리지 Download PDFInfo
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- KR101356585B1 KR101356585B1 KR1020060082756A KR20060082756A KR101356585B1 KR 101356585 B1 KR101356585 B1 KR 101356585B1 KR 1020060082756 A KR1020060082756 A KR 1020060082756A KR 20060082756 A KR20060082756 A KR 20060082756A KR 101356585 B1 KR101356585 B1 KR 101356585B1
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- Prior art keywords
- staple
- staples
- drivers
- anvil
- driver
- Prior art date
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B25—HAND TOOLS; PORTABLE POWER-DRIVEN TOOLS; MANIPULATORS
- B25C—HAND-HELD NAILING OR STAPLING TOOLS; MANUALLY OPERATED PORTABLE STAPLING TOOLS
- B25C5/00—Manually operated portable stapling tools; Hand-held power-operated stapling tools; Staple feeding devices therefor
- B25C5/02—Manually operated portable stapling tools; Hand-held power-operated stapling tools; Staple feeding devices therefor with provision for bending the ends of the staples on to the work
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
- A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/10—Surgical instruments, devices or methods, e.g. tourniquets for applying or removing wound clamps, e.g. containing only one clamp or staple; Wound clamp magazines
- A61B17/105—Wound clamp magazines
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B25—HAND TOOLS; PORTABLE POWER-DRIVEN TOOLS; MANIPULATORS
- B25C—HAND-HELD NAILING OR STAPLING TOOLS; MANUALLY OPERATED PORTABLE STAPLING TOOLS
- B25C5/00—Manually operated portable stapling tools; Hand-held power-operated stapling tools; Staple feeding devices therefor
- B25C5/02—Manually operated portable stapling tools; Hand-held power-operated stapling tools; Staple feeding devices therefor with provision for bending the ends of the staples on to the work
- B25C5/0285—Hand-held stapling tools, e.g. manually operated, i.e. not resting on a working surface during operation
- B25C5/0292—Hand-held stapling tools, e.g. manually operated, i.e. not resting on a working surface during operation with the objects to be stapled together introduced perpendicularly to the longitudinal axis of the tool in an opening formed by an anvil and a plunger
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B25—HAND TOOLS; PORTABLE POWER-DRIVEN TOOLS; MANIPULATORS
- B25C—HAND-HELD NAILING OR STAPLING TOOLS; MANUALLY OPERATED PORTABLE STAPLING TOOLS
- B25C5/00—Manually operated portable stapling tools; Hand-held power-operated stapling tools; Staple feeding devices therefor
- B25C5/02—Manually operated portable stapling tools; Hand-held power-operated stapling tools; Staple feeding devices therefor with provision for bending the ends of the staples on to the work
- B25C5/04—Manually operated portable stapling tools; Hand-held power-operated stapling tools; Staple feeding devices therefor with provision for bending the ends of the staples on to the work with means for forming the staples in the tool
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
- A61B2017/07214—Stapler heads
- A61B2017/07242—Stapler heads achieving different staple heights during the same shot, e.g. using an anvil anvil having different heights or staples of different sizes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
- A61B2017/07214—Stapler heads
- A61B2017/07257—Stapler heads characterised by its anvil
- A61B2017/07264—Stapler heads characterised by its anvil characterised by its staple forming cavities, e.g. geometry or material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
- A61B2017/07214—Stapler heads
- A61B2017/07278—Stapler heads characterised by its sled or its staple holder
Abstract
본 발명은 축방향에서 선택적으로 작동가능한 액츄에이터와, 개방 및 폐쇄 위치 사이에서 선택적으로 이동가능한 앤빌(anvil) 부분을 갖는 봉합 장치(stapling device)와 함께 사용하기 위한 스테이플 카트리지를 공개한다. 본 발명의 다양한 실시예들에는 제 1 및 제 2 스테이플 드라이버를 이동가능하게 지지하는 카트리지 본체를 포함한다. 상기 스테이플 드라이버는 그 위에 스테이플을 각각 지지하고 액츄에이터에 의한 작동시 앤빌과 접촉하여 성형하도록 스테이플들을 구동하게 작용한다. 본 발명의 다양한 실시예들은 상이한 사이즈들의 스테이플들을 사용할 필요없이 스테이플들의 높이를 최종 형성된 높이들로 변하게 할 수 있다.
스테이플, 봉합, 카트리지, 조직, 절개
Description
도 1은 개방 위치의 외과용 봉합 및 절단(stapling and severing) 장치의 부분절단된 측 입면도.
도 2는 외과용 봉합 및 절단 장치의 말단 작동기(end effector)의 도 1의 2-2선을 따른 측단면도.
도 3은 도 2의 외과용 봉합 및 절단 장치의 발사용 바(firing bar)의 확대 측 입면도.
도 4는 도 2의 외과용 봉합 및 절단 장치의 발사용 바의 확대 정면도.
도 5는 말단 작동기의 조임(pinching)을 방지하기 위해 중간 핀(middle pin)이 없는 발사용 바를 포함하는, 도 1의 외과용 봉합 및 절단 장치를 위한 다른 말단 작동기의 측 단면도.
도 6은 클램핑되지 않고 발사되지 않은("시작") 위치에서의 내부 부분들을 노출하도록 좌측면이 제거된 도 1의 외과용 봉합 및 절단 장치의 선단부의 핸들 부분의 측 입면도.
도 7은 도 1의 외과용 봉합 및 절단 장치의 선단부의 핸들 부분의 분해 사시 도.
도 8은 폐쇄("클램핑된") 위치의 내부 부분들을 노출시키도록 좌측면이 제거된 도 1의 외과용 봉합 및 절단 장치의 선단부의 핸들 부분의 측 입면도.
도 9는 봉합 및 절단된("발사된") 위치의 내부 부분들을 노출하도록 좌측면이 제거된 도 1의 외과용 봉합 및 절단 장치의 선단부의 핸들 부분의 측 입면도.
도 10은 본 발명의 일 실시예의 말단 작동기에 설치된 스테이플 카트리지의 평면도.
도 11은 본 발명의 스테이플 카트리지 실시예의 일부분의 확대 평면도.
도 12는 본 발명의 다양한 실시예들과 함께 사용될 수 있는 스테이플의 측면도.
도 13은 그 위에 2개의 스테이플을 지지하는 본 발명의 일 실시예의 내측 이중 드라이버(inside double driver)의 정면 입면도.
도 14는 도 13의 내측 이중 드라이버와 스테이플들의 평면도.
도 14a는 폐쇄 위치일 때 앤빌의 상응하는 부분들도 예시하는, 말단 작동기에 장착된 스테이플 카트리지의 일부분 내의 도 13의 내측 이중 드라이버의 입면도.
도 15는 도 13 및 도 14의 내측 이중 드라이버와 스테이플들의 우측 입면도.
도 15a는 카트리지 트레이와 앤빌의 상응하는 부분들이 그 사이의 관계를 예시하기 위해 파선들로 예시된 도 15의 내측 이중 드라이버의 다른 측 입면도.
도 16은 그 위에 스테이플을 지지하는 본 발명의 일 실시예의 외측 단일 드 라이버의 정면 입면도.
도 16a는 카트리지 트레이와 앤빌의 일부가 그 사이의 관계를 예시하도록 도시된 도 16의 외측 단일 드라이버의 다른 정면도.
도 17은 도 16의 외측 단일 드라이버 및 스테이플의 평면도.
도 18은 도 1의 외과용 봉합 및 절단 장치의 작동 부분의 등각 분해도.
도 19는 발사용 바, 기다란 채널, 웨지 슬레드(wedge sled), 스테이플 드라이버, 스테이플 및 스테이플 카트리지 간의 단면 관계를 도시하는 도 10의 선 19-19를 따라 취한 단면도.
도 20은 본 발명의 웨지 슬레드 실시예의 사시도.
도 21은 도 20에 예시된 웨지 슬레드의 내측 슬레드 캠(inside sled cam)의 측 입면도.
도 22는 도 20에 예시된 웨지 슬레드의 외측 슬레드 캠의 측 입면도.
도 23은 카트리지가 대부분 제거되어 발사용 바의 중간 핀에 대한 출발 위치의 웨지 슬레드와 예시적인 이중 슬레드 드라이버와 단일 스테이플 드라이버를 노출하며, 앤빌이 상부 또는 개방 위치인 도 1의 외과용 봉합 및 절단 장치의 말단부의 말단 작동기의 등각도.
도 24는 앤빌이 상부 또는 개방 위치에서 발사용 바의 절단 에지와 스테이플 카트리지를 노출시키는 도 1의 외과용 봉합 및 절단 장치의 말단부의 말단 작동기의 등각도.
도 25는 앤빌이 상부 또는 개방 위치이며 스테이플 카트리지가 완전히 제거 되고 기다란 채널의 일부분이 발사용 바의 최하단 핀을 노출시키도록 제거된 도 1의 외과용 봉합 및 절단 장치의 말단부의 등각도.
도 26은 웨지 슬레드를 노출하기 위해 도 24의 선 26-26을 따라 일반적으로 취해진 단면이지만 또한 길이방향 중심선을 따라 발사용 바를 예시하는, 도 1의 외과용 봉합 및 절단 장치의 폐쇄 위치의 스테이플 카트리지, 기다란 채널, 앤빌 사이의 기계적 관계를 단면으로 도시하는 측 입면도.
도 27은 웨지의 외측 캠이 외측 단일 드라이버 근처에 있는 본 발명의 스테이플 카트리지의 일 실시예의 일부분의 단면도.
도 28은 웨지 슬레드의 외측 캠이 3개의 외측 단일 드라이버와 결합하는 본 발명의 스테이플 카트리지의 일 실시예의 일부분의 단면도.
도 29는 본 발명의 일 실시예의 외과용 봉합 및 절단 장치를 사용하는 절단선의 각각의 측면에 설치된 스테이플들의 라인의 개략도.
도 30은 본 발명의 내측 드라이버 실시예에 의해 형성되는 스테이플의 예시도.
도 31은 본 발명의 외측 드라이버 실시예에 의해 형성되는 다른 스테이플의 예시도.
도 32는 본 발명의 다른 실시예의 외과용 봉합 및 절단 장치를 사용하는 절단선의 각각의 측면에 설치되는 스테이플들의 라인의 개략도.
도 33은 본 발명의 다른 실시예의 외과용 봉합 및 절단 장치를 사용하여 절단선의 각각의 측면에 설치되는 스테이플들의 라인의 개략도.
도 34는 본 발명의 다른 실시예의 외과용 봉합 및 절단 장치를 사용하여 절단선의 각각의 측면에 설치되는 스테이플들의 라인의 개략도.
도 35는 부분적으로 닫혔지만 클램핑되지 않은 위치에서 조직을 쥐는(gripping) 말단 작동기의 길이방향 중심선을 따라 취한 도 1의 외과용 봉합 및 절단 장치의 측면 입면도.
도 36은 폐쇄 또는 클램핑된 위치에서의 도 1의 외과용 봉합 및 절단 장치의 부분 절취된 측면 입면도.
도 37은 조직이 적절하게 압축된 폐쇄 또는 클램핑된 위치의 도 1의 외과용 봉합 및 절단 장치의 말단부의 중심선 단면도.
도 38은 부분적으로 발사된 위치의 도 1의 외과용 봉합 및 절단 장치의 말단부의 중심선 단면도.
도 39는 부분적으로 발사된 위치의 도 1의 외과용 봉합 및 절단 장치의 부분적으로 절취된 측면 입면도.
도 40은 완전히 발사된 위치의 도 1의 외과용 봉합 및 절단 장치의 말단부의 중심선 단면도.
도 41은 완전히 발사된 위치의 도 1의 외과용 봉합 및 절단 장치의 부분적으로 절취된 측면 입면도.
※도면의 주요부분에 대한 부호의 설명※
10: 외과용 봉합 및 절단 장치 12: 말단 작동기
14: 발사용 바 16: 기다란 채널
18: 앤빌 20: 핸들 부분
22: 작동 부분 23: 샤프트
24: 손잡이 26: 폐쇄 트리거
본 발명은, 일반적으로 몇 라인의 스테이플들을 붙일 수 있는 봉합 장치에 대한 것이고, 보다 상세하게는, 조직을 절단하는 동시에 조직에 상이하게 형성된 스테이플 높이를 갖는 몇 라인의 스테이플들을 붙일 수 있는 외과용 봉합 장치와 함께 사용하기 위한 스테이플 카트리지에 관련한 개선점들에 대한 것이다.
외과용 봉합기들은 조직에 길이방향 절개부를 만드는 동시에 절개부의 대향하는 측면들 상에 몇 라인의 스테이플들을 가하기 위해 종래 기술에서 사용되어 왔다. 이러한 장치들은 내시경 또는 복강경 응용예를 위한 것인 경우 캐뉼라(cannula) 통로를 통과할 수 있는 한 쌍의 함께 작용하는 조(jaw) 부재를 포함한다. 상기 조 부재들 중 하나는 적어도 2개의 측방향에서 이격된 열의 스테이플을 갖는 스테이플 카트리지를 수용한다. 다른 조 부재는 카트리지에서 스테이플들의 열들과 정렬된 스테이플-성형 포켓들을 갖는 앤빌을 형성한다. 장치는 말단측에서 구동되었을 때 스테이플 카트리지의 구멍들을 통과하고 앤빌을 향해 스테이플들을 발사하도록 스테이플들을 지지하는 드라이버들과 결합하는 다수의 왕복운동하는 웨지(wedge)를 포함한다.
내시경 응용예에 적합한 외과용 봉합기의 일례가 미국 특허출원 제 US2004/0232196 A1호에 설명되어 있으며, 이 내용 전체는 본원에 참고문헌으로서 포함된다. 사용시에, 임상의는 발사 전에 조직을 위치결정하기 위해 조직 상에 봉합기의 조 부재들을 닫을 수 있다. 일단 임상의가 조 부재들이 조직을 적절히 쥐고 있다고 판단하면, 임상의는 외과용 봉합기를 발사하여 조직을 절단 및 봉합할 수 있다. 동시에 절단 및 봉합하는 것은 이러한 작용이 각각 절단하거나 봉합만을 하는 상이한 외과용 도구로 순차적으로 수행될 때 발생할 수 있는 합병증을 회피한다.
조직이 조직 구성이 변하는 영역에 걸쳐 처리될 때, 절단선으로부터 가장 가까운 스테이플이 절단선으로부터 가장 먼 스테이플의 성형 높이(formed height)보다 작은 성형 높이를 갖는 것이 유익하다. 실제로는, 내측 스테이플들의 열들은 지혈 장벽(hemostatic barrier)을 제공하는 작용을 하는 반면, 보다 큰 성형 높이들을 갖는 외측 열들의 스테이플들은 조직이 단단히 압축된 지혈 부위로부터 압축되지 않은 인접 부위로 천이하는 곳에서 고정하는 효과를 제공한다. 다른 응용예들에서, 단일 라인의 스테이플들에서는 스테이플들이 상이한 성형 높이들을 갖는 것이 유용할 수 있다.
프루이트(Pruitt)의 미국 특허 제 4,941,623호 및 5,027,834호는 상이한 성형 높이들을 갖는 스테이플들의 라인들을 최종적으로 달성하기 위해 상이한 가지(prong) 길이들을 갖는 스테이플들을 사용하는 외과용 봉합기 및 카트리지 장치를 공개한다. 유사하게, WO 2003/094747A1호는 내측 2개 열 및 중간 열들의 스테이플들에 사용된 스테이플들보다 큰 스테이플들을 외측 2개 열의 스테이플이 포함하는 6개 열의 스테이플들을 갖는 외과용 봉합기 및 카트리지를 공개한다. 그러므로, 이들 모든 접근 방식은 동일한 카트리지에 상이한 사이즈의 스테이플들을 사용할 것을 필요로 한다.
결과적으로, 동일한 카트리지에 상이한 사이즈의 스테이플들을 가질 필요가 없이 상이한 성형 높이들을 갖는 스테이플들의 라인들을 형성할 수 있는 봉합 장치를 위한 개선된 카트리지에 대한 큰 필요성이 존재한다.
본 발명의 일 실시예에 따르면, 축방향에서 선택적으로 작동가능한 액츄에이터와, 개방 위치와 폐쇄 위치 사이에서 선택적으로 이동가능한 앤빌 부분을 갖는 봉합 장치와 함께 사용하기 위한 스테이플 카트리지가 제공된다. 일 실시예에서, 상기 스테이플 카트리지는 폐쇄 위치에서 앤빌 부분과 선택적으로 마주하는 관계(confronting relationship)로 봉합 장치 내에 지지가능한 카트리지 본체를 포함한다. 상기 카트리지 본체는 그 안에 액츄에이터를 축방향으로 수용하게 구성된다. 스테이플 카트리지는 액츄에이터가 카트리지 본체를 통해 축방향으로 전진할 때 제 1 스테이플 드라이버가 앤빌이 폐쇄 위치일 때 앤빌을 향하는 방향으로 구동되도록 액츄에이터에 의해 접촉되게 카트리지 본체 내에 이동가능하게 지지된 하나 이상의 제 1 스테이플 드라이버를 추가로 포함한다. 각각의 제 1 스테이플 드라이버는 그 위에 스테이플을 지지하기 위해 그 안에 제 1 스테이플 지지 크래들(cradle)을 갖는다. 제 1 스테이플 지지 크래들은 닫힌 앤빌의 상응하는 부분으로부터 제 1 스테이플 형성 거리에 위치한다. 하나 이상의 제 2 스테이플 드라이버는 액츄에이터가 카트리지 본체를 통해 축방향으로 전진할 때 제 2 스테이플 드라이버들이 닫힌 앤빌을 향하는 방향으로 구동되도록 액츄에이터에 의한 접촉을 위해 카트리지 본체 내에서 이동가능하게 지지되어 있다. 각각의 제 2 스테이플 드라이버는 지지 크래들 위에 다른 스테이플을 지지하도록 드라이버 안에 제 2 스테이플 지지 크래들을 갖는다. 제 2 스테이플 지지 크래들은 닫힌 앤빌의 다른 부분으로부터 제 2 스테이플 형성 거리에 위치한다. 제 2 스테이플 형성 거리는 제 1 스테이플 형성 거리와는 상이하다.
본 발명의 다른 실시예에 따르면, 개방 위치와 폐쇄 위치 사이에서 이동하기 위해 피벗가능하게 부착되는 앤빌 부분을 포함하는 말단 작동기(end effector)를 갖는 외과용 장치와 함께 사용하기 위해 스테이플 카트리지가 제공된다. 장치는 말단 작동기 내에서 선택적으로 축방향에서 왕복운동가능한 발사용 바(firing bar)를 추가로 포함한다. 스테이플 카트리지의 일 실시예는 말단 작동기 내에 지지되는 사이즈를 갖는 카트리지 본체를 포함한다. 카트리지 본체는 그 안에 발사용 바를 왕복운동하게 수용하도록 그 안에서 길이방향으로 연장하는 슬롯을 갖는다. 상기 카트리지는 본체 내에서 길이방향으로 연장하는 슬롯의 제 1 측면 상에서 내측 스테이플 드라이버의 제 1 열에 축방향으로 정렬된 다수의 제 1 내측 스테이플 드라이버를 추가로 포함한다. 다수의 제 2 내측 스테이플 드라이버도 길이방향으로 연장하는 슬롯의 제 2 측면 상에서 내측 스테이플 드라이버의 제 2 열에 축방향으로 정렬된다. 내측 스테이플 드라이버들은 앤빌이 폐쇄 위치일 때 앤빌을 향하는 선택적 운동을 위해 카트리지 본체 내에서 이동가능하게 지지되어 있다. 각각의 내측 스테이플 드라이버는 그 위에 스테이플을 지지하는 제 1 스테이플 지지 크래들을 갖는다. 제 1 스테이플 지지 크래들은 앤빌이 폐쇄 위치일 때 앤빌의 상응하는 부분으로부터 제 1 스테이플 형성거리만큼 각각 위치한다. 상기 카트리지는 외측 스테이플 드라이버들의 제 1 열에 축방향으로 정렬된 다수의 제 1 외측 스테이플 드라이버를 추가로 포함한다. 제 1 열의 외측 스테이플 드라이버는 길이방향으로 연장하는 슬롯의 제 1 측면 상에 위치하며 제 1 열의 내측 스테이플 드라이버에 인접한다. 상기 카트리지는 외측 스테이플 드라이버의 제 2 열(row)에 축방향으로 정렬된 다수의 제 2 외측 스테이플 드라이버를 추가로 포함한다. 외측 스테이플 드라이버의 제 2 열은 상기 기다란 슬롯의 제 2 측면 상에 위치하며 내측 스테이플 드라이버의 제 2 열에 인접한다. 각각의 외측 스테이플 드라이버는 앤빌이 폐쇄 위치일 때 앤빌을 향해 선택적으로 구동하는 운동을 위해 카트리지 본체 내에 이동가능하게 지지된다. 각각의 외측 스테이플 드라이버는 지지 크래들 위에 스테이플들 중 다른 하나를 지지하기 위한 제 2 스테이플 지지 크래들을 갖는다. 각각의 제 2 스테이플 지지 크래들은 앤빌이 폐쇄 위치일 때 앤빌의 다른 상응하는 부분으로부터 제 2 스테이플 형성 거리에 위치한다. 제 2 스테이플 형성 거리는 제 1 스테이플 형성 거리와 상이하다. 웨지 슬레드는 카트리지 본체 내에서 발사용 바와 접촉하여 구동하도록 그리고 다수의 제 1 및 제 2 내측 및 외측 스테이플 드라이버와 함께 접촉하여 작동하도록 지지되어 있어서, 발사용 바가 기다란 슬롯 내에서 제 1 축방향으로 이동함에 따라 앤빌이 폐쇄 위치일 때 웨지 슬레드가 각각의 내측 및 외측 드라이버를 앤빌을 향해 구동하하여 그 위에 지지된 스테이플들이 앤빌과 성형하는 접촉을 하게 한다.
본 발명의 다른 실시예에 따르면, 개방 위치와 폐쇄 위치 사이에서 이동하기 위해 피벗가능하게 부착된 앤빌 부분을 포함하고, 그리고 그 안에서 선택적으로 축방향으로 왕복운동가능한 발사용 바를 추가로 포함하는 말단 작동기를 갖는 외과용 장치와 함께 사용하기 위한 스테이플 카트리지가 제공된다. 상기 스테이플 카트리지의 일 실시예는 말단 작동기 내에 지지되는 사이즈를 갖는 카트리지 본체를 포함한다. 카트리지 본체는 내부에 발사용 바를 왕복운동가능하게 수용하는 길이방향 연장 슬롯을 갖는다. 다수의 제 1 내측 스테이플 드라이버는 카트리지 본체 내에서 길이방향 연장 슬롯의 제 1 측면 상에 제 1 내측 스테이플 드라이버들의 제 1 열에 축방향으로 정렬된다. 각각의 제 1 내측 스테이플 드라이버는 앤빌이 폐쇄 위치일 때 앤빌을 향해 선택적으로 이동하기 위해 카트리지 본체 내에 이동가능하게 지지되어 있다. 각각의 제 1 내측 스테이플 드라이버는 그 위에 하나 이상의 스테이플을 지지한다. 이 실시예는 제 1 내측 스테이플 드라이버들의 제 1 열에 인접한 제 1 외측 스테이플 드라이버들의 제 1 열에 축방향으로 정렬된 다수의 제 1 외측 스테이플 드라이버를 추가로 포함한다. 각각의 제 1 외측 스테이플 드라이버는 앤빌이 폐쇄 위치일 때 앤빌을 향해 선택적으로 이동하도록 카트리지 본체 내에 이동가능하게 지지되어 있다. 각각의 제 1 외측 스테이플 드라이버는 그 위에 스테이플들 중 다른 하나를 지지한다. 상기 카트리지는 발사용 바에 의해 접촉하기 위해 카트리지 본체 내에 지지된 웨지 슬레드를 추가로 포함한다. 상기 웨지 슬레드는 제 1 슬레드 캠 높이를 갖는 제 1 내측 슬레드 캠을 포함한다. 상기 제 1 내측 슬레드 캠은 제 1 내측 스테이플 드라이버들이 제 1 슬레드 캠 높이와 같은 제 1 거리만큼 앤빌을 향해 구동되도록 제 1 축방향에서 기다란 슬롯을 통해 축방향에서 발사용 바가 전진할 때 제 1 내측 스테이플 드라이버들의 제 1 열에서 제 1 내측 스테이플 드라이버들과 순차적으로 슬라이딩 작동하여 접촉하도록 배향되어 있다. 웨지 슬레드는 제 1 슬레드 캠 높이와는 상이한 제 2 슬레드 캠 높이를 갖는 제 1 외측 슬레드 캠을 추가로 포함한다. 제 1 외측 슬레드 캠은 제 1 외측 스테이플 드라이버들이 제 2 슬레드 캠 높이와 같은 제 2 거리만큼 앤빌을 향해 구동되도록 제 1 축방향에서 기다란 슬롯을 통해 축방향에서 발사용 바가 전진할 때 제 1 외측 스테이플 드라이버들의 제 1 열에서 제 1 외측 스테이플 드라이버들과 순차적으로 작동하여 접촉하도록 배향된다.
본 발명의 일 특징은 상이한 성형 (최종) 높이들을 갖는 스테이플을 형성하는 능력을 도우면서 몇 개의 열 또는 다른 다수의 동일한 사이즈의 스테이플을 사용하는 봉합 장치를 위한 스테이플 카트리지를 제공하는 것이다. 몇몇 실시예에서, 최종 높이들은 인접한 스테이플 열들에 걸쳐 변할 수 있다. 다른 실시예에서, 스테이플들의 성형 높이들은 스테이플들의 단일 열에서 스테이플들마다 변할 수 있다. 따라서, 본 발명의 다양한 실시예들은 다양한 성형 높이들을 갖는 스테이플들을 달성하기 위해 상이한 사이즈들의 스테이플들을 사용해야만 하는 다른 스테이플 카트리지들 및 봉합 장치들의 단점들에 대한 해결책을 제공한다. 그러나, 당업자는 하기의 상세한 설명이 진행됨에 따라 상술한 것 및 다른 세부사항, 특징 및 장점들이 보다 명백해짐을 쉽게 알 수 있을 것이다.
첨부한 도면들은 본 발명의 실시예들의 일부에 포함되고 이를 구성하고 예시하며 본 발명의 일반적인 설명과 후술하는 실시예들의 상세한 설명과 함께 본 발명의 원리들을 설명하는데 도움을 준다.
도면으로 돌아가서, 유사한 도면부호는 몇 개의 도면에 걸쳐 유사한 구성요소를 나타내며, 도 1 및 도 2는 본 발명의 독특한 장점들을 실시할 수 있는 외과용 봉합 및 절단 장치(10)의 일 실시예를 예시한다. 그러나, 본 발명의 상세한 설명이 진행함에 따라, 독자는 본 발명의 독특하고 신규한 특징들이 본 발명의 진의 및 범위를 벗어나지 않고 다양한 다른 봉합기 및 봉합 장치에 연계하여 유익하게 사용될 수 있음을 이해할 것이다. 따라서, 본 발명의 다양한 실시예들에 제공되는 보호 범위는 본원에서 설명하는 특정한 타입의 외과용 봉합 및 절단 장치들에의 사용에만 제한되지 않는다.
도 1 및 도 2에서 볼 수 있듯이, 외과용 봉합 및 절단 장치(10)는 말단 작동기(12)의 간격을 유리하게 제어하는 액츄에이터 또는 E-빔 발사 메커니즘(14; "발사용 바")을 갖는 말단 작동기(12)를 포함한다. 특히, 기다란 채널(16)과 피벗식으로 이동가능한 앤빌(18)은 효과적인 봉합 및 절단을 보장하는 간격으로 유지된다. 말단 작동기(12)에 잡히는 조직의 양의 변화에 관련한 문제들이 회피된다.
용어 "선단(proximal)"과 "말단(distal)"은 본원에서 장치의 핸들을 쥐는 임상의를 기준으로 사용된다. 그러므로, 말단 작동기(12)는 보다 선단측의 핸들 부분(20)에 대해 말단측에 있다. 또한, 편의 및 명확성을 위해, "수직"과 "수평"과 같은 공간적인 용어가 본원에서 도면에 관련하여 사용되었다. 그러나, 외과용 장치들은 많은 배향과 위치에서 사용되고 이들 용어는 제한적이거나 절대적이지 않다.
상기 외과용 봉합 및 절단 장치(10)는 작동 부분(22)에 연결된 핸들 부분(20)을 포함하며, 작동 부분은 말단측에서 말단 작동기(12)로 종료하는 샤프트(23)를 추가로 포함한다. 핸들 부분(20)은 손잡이(24; pistol grip)를 포함하며, 임상의가 이 손잡이를 향해 폐쇄 트리거(closure trigger)(26)를 피벗식으로 당기면 말단 작동기(12)의 기다란 채널(16)을 향해 앤빌(18)이 클램핑 또는 닫히게 된다. 발사 트리거(28; firing trigger)는 폐쇄 트리거(26) 보다 외측에 있고 임상의가 피벗식으로 당기면 말단 작동기(12)의 클램핑된 조직의 절단 및 봉합이 일어난다.
실제로, 상기 폐쇄 트리거(26)가 먼저 작동된다. 일단 임상의가 말단 작동기(12)의 위치결정에 만족하면, 임상의는 폐쇄 트리거(26)를 손잡이(24)에 가까운 완전히 닫힌 잠긴 위치로 당길 수 있다. 그 다음에, 발사 트리거(28)가 작동된다. 발사 트리거(28)는 임상의가 압력을 제거하면 스프링 작용으로 복귀한다. 핸들 부분(20)의 선단부를 누를 때 해제 버튼(30)은 모든 잠긴 폐쇄 트리거(26)를 해제한다.
폐쇄 슬리브(32)는 프레임(34)을 둘러싸며, 다음에 상기 프레임이 발사 트리거(28)에 의해 위치결정된 발사 구동 부재(36)를 둘러싼다. 프레임(34)은 핸들 부분(20)과 말단 작동기(12)를 연결한다. 폐쇄 슬리브(32)가 예시된 바와 같이 폐쇄 트리거(26)에 의해 선단쪽으로 당겨지면, 앤빌(18)은 스프링 작용으로 열리며 기다란 채널(16)로부터 멀어지게 피벗하고 폐쇄 슬리브(32)와 함께 선단쪽으로 병진운동한다. 기다란 채널(16)은 스테이플 카트리지(37)를 수용한다.
도 2 내지 도 4를 특히 참조하면, 상기 발사용 바(14)는 발사 중에 말단 작동기(12)의 간격을 제어하는 3개의 수직으로 이격된 핀을 포함한다. 특히, 상부 핀(38)은 기다란 채널(16)과 앤빌(18) 간의 피벗 근처에서 앤빌 포켓(40)에 들어가도록 다단으로 되어 있다(staged). 앤빌(18)이 폐쇄 상태에서 발사되면, 상부 핀(38)은 앤빌(18)을 통해 말단측으로 연장하는 길이방향 앤빌 슬롯(42) 내에서 말단쪽으로 전진한다. 앤빌(18)의 크지 않은 어떠한 상방향 휨은 상부 핀(38)에 의해 부여되는 하향력에 의해 극복된다. 발사용 바(14)는 기다란 채널(16)의 채널 슬롯(45)과 상방향으로 결합하는 최하단 핀 또는 발사용 바 캡(44)을 또한 포함하여, 상부 핀(38)과 함께 작용하여 그들 사이에 클램핑된 조직이 과다한 경우에 앤빌(18)과 기다란 채널(16)을 당겨 약간 더 가깝게 되도록 한다.
상기 발사용 바(14)는 유리하게는 카트리지(300)의 하부 표면 및 기다란 채널(16)의 상부 표면에 형성된 발사 구동 슬롯(47)을 통과하여 후술하는 바와 같이 그 안의 스테이플들을 구동하는 중간 핀(46)을 포함한다. 상기 중간 핀(46)은 기다란 채널(16)에 대해 슬라이딩하여 유익하게는 말단부에서 말단 작동기(12)가 낀 채로 닫히는(pinched shut) 경향에 저항한다. 중간 핀(46)의 장점을 예시하기 위해, 도 5는 발사용 바(14')에 중간 핀이 없는 다른 말단 작동기(12')를 예시한다. 이 예시에서, 상기 말단 작동기(12')는 말단부에서 낀 채로 닫히게 되며, 이는 원하는 스테이플 형성에 손상을 끼치는 경향이 있다.
도 2 내지 도 4로 돌아가서, 상기 발사용 바(14) 상의 상부 핀 및 중간 핀(38, 46) 사이의 말단에 제공된 절단 에지(48)가 클램핑된 조직을 절단하기 위해 카트리지(37)의 선단에 제공된 수직 슬롯(49)을 통해 횡단한다. 기다란 채널(16)과 앤빌(18)에 대해 발사용 바(14)를 확실하게 위치결정하면 효과적인 절단이 수행됨을 보장한다.
E-빔에 의해 제공되는 확실한 수직 간격은 내시경 장치에 유용한 제한된 사이즈에 적합하다. 또한, E-빔 발사용 바(14)는 도 5에 예시된 위치와 유사하게, 말단부에서 수직 편향을 부여하는 캠버(camber)를 갖는 앤빌(15)을 제조할 수 있게 한다. 이 캠버된 앤빌(15)은 유리하게는 앤빌(15)의 두께가 감소되어도 말단 작동기(12)에 원하는 갭을 달성하는 것을 도우며, 이는 내시경 장치의 사이즈 제한에 보다 적합할 수 있다.
도 6 내지 도 9를 참조하면, 핸들 부분(20)은 글래스-충전된 폴리카보네이트와 같은 중합체 재료로부터 성형된 제 1 및 제 2 베이스 섹션(50, 52; base section)을 포함한다. 상기 제 1 베이스 섹션(50)은 다수의 원통-형상 핀(54)을 구비한다. 상기 제 2 베이스 섹션(52)은 육각형 구멍(58)을 각각 갖는 다수의 연장 부재(56)를 포함한다. 원통-형상 핀(54)들은 육각형 구멍(58)들 내에 수용되고 조립 상태로 제 1 및 제 2 베이스 섹션(50, 52)을 유지하기 위해 그 안에서 마찰에 의해 잡혀 있다.
회전 손잡이(60; rotating knob)는 길이방향 축 둘레에서 작동 부분(22)과의 결합 및 회전을 위해 완전히 이를 관통하는 구멍(62)을 갖는다. 상기 회전 손잡이(60)는 구멍(62)의 적어도 일부분을 따라 연장하는 내측 돌출 보스(64; boss)를 포함한다. 돌출 보스(64)는 회전 손잡이(60)의 회전에 의해 폐쇄 슬리브(32)가 회전되도록 폐쇄 슬리브(32)의 선단 부분에 형성되는 길이방향 슬롯(66) 내에 수용된다. 보스(64)는 프레임(34)을 통해 더 연장하고 발사 구동 부재(36)의 일부분과 접촉하여 이들도 회전하게 한다. 그러므로, 말단 작동기(12; 도 6 내지 9에 도시되지 않음)는 회전 손잡이(60)와 함께 회전한다.
프레임(34)의 선단부(68)는 회전 손잡이(60)를 선단쪽으로 통과하고, 베이스 섹션들(50, 52)으로부터 각각 연장하는 대향하는 채널 고정 부재(72)들에 의해 결합되는 원주방향 노치(70; notch)를 구비한다. 제 2 베이스 섹션(52)의 채널 고정 부재(72)만이 도시되어 있다. 베이스 섹션들(50, 52)로부터 연장하는 채널 고정 부재(72)들은 프레임(34)이 핸들 부분(20)에 대해 길이방향으로 이동하지 않도록 프레임(34)을 핸들 부분(20)에 고정시키는 작용을 한다.
폐쇄 트리거(26)는 핸들 섹션(74), 기어 세그먼트 섹션(76), 중간 섹션(78)을 갖는다. 구멍(80)은 중간 섹션(78)을 통해 연장한다. 제 2 베이스 섹션(52)으로부터 연장하는 원통형 지지 부재(82)는 핸들 부분(20) 상에 폐쇄 트리거(26)를 피벗식으로 장착하기 위해 구멍(80)을 관통한다. 제 2 베이스 섹션(52)으로부터 연장하는 제 2 원통형 지지 부재(83)는 핸들 부분(20) 상에 피벗식으로 장착하기 위해 발사 트리거(28)의 구멍(81)을 관통한다. 육각형 구멍(84)이 제 1 베이스 섹션(50)으로부터 연장하는 고정 핀(도시않음)을 수용하기 위해 원통형 지지 부재(83)에 제공된다.
폐쇄 요크(86; yoke)가 핸들 부분(20) 내에 왕복 운동이 가능하게 수용되고 폐쇄 트리거(26)로부터 폐쇄 슬리브(32)로의 운동을 전달하는 작용을 한다. 요크(86)의 오목부(89)를 통해 연장하는 고정 부재(72)와 제 2 베이스 섹션(52)으로부터 연장하는 지지 부재(88)들은 핸들 부분(20) 내에서 요크(86)를 지지한다.
폐쇄 슬리브(32)의 선단부(90)는 요크(86)의 말단부(96)에 형성되는 수용 오목부(94: receiving recess)로 스냅-결합(snap-fit)하는 플랜지(92)를 구비한다. 요크(86)의 선단부(98)는 폐쇄 트리거(26)의 기어 세그먼트 섹션(76)에 의해 맞물리는 기어 랙(100; gear rack)을 갖는다. 폐쇄 트리거(26)가 핸들 부분(20)의 손잡이(24)를 향해 이동될 때, 요크(86) 및 폐쇄 슬리브(32)가 말단으로 이동하여, 요크(86)를 선단으로 편향시키는 스프링(102)을 압축시킨다. 폐쇄 슬리브(32)가 말단쪽으로 이동하면 앤빌(18)이 말단쪽으로 말단 작동기(12)의 기다란 채널(16)을 향해 피벗식으로 병진 이동하게 하고 선단쪽으로의 이동은 후술하는 바와 같이 닫히게 한다.
상기 폐쇄 트리거(26)는 발사 트리거(28)의 결합면(128)과 상호작용하는 정면(130)에 의해 개방 위치로 앞쪽으로 편향된다. 핀(106) 둘레에서 핸들 부분(20)에서 상부에서 후방으로 피벗하는 클램프 제 1 후크(104)는 폐쇄 트리거(26)가 폐쇄 위치에 클램핑될 때까지 손잡이(24)를 향해 발사 트리거(28)의 움직임을 억제한다. 후크(104)는 발사 트리거(28)의 잠금(lockout) 핀(107)과 결합하여 발사 트리거(28)의 움직임을 억제한다. 또한, 후크(104)는 폐쇄 트리거(26)와 접촉한다. 특히, 후크(104)의 전방 돌출부(108)는 폐쇄 트리거(26)의 중간 섹션(78) 상의 부재(110)와 결합하며, 부재(100)는 핸들 섹션(74)을 향해 구멍(80)의 외측에 있다. 후크(104)는 폐쇄 트리거(26)의 부재(110)와 접촉하도록 편향되고 해제 스프링(112)에 의해 발사 트리거(28)의 잠금 핀(107)과 결합한다. 폐쇄 트리거(26)가 눌릴 때, 후크(104)가 상부에서 후방으로 이동되며, 후크(104) 상의 후방 돌출부(114)와 해제 버튼(30) 상의 전방 돌출부(116) 사이에 잡힌 해제 스프링(112)을 누른다.
상기 요크(86)가 폐쇄 트리거(26)의 선단쪽 이동에 반응하여 말단으로 이동할 때, 해제 버튼(30)의 상부 래치 암(118)은 요크(86)의 선단측 하부 부분의 상방향으로 제공된 오목부(122)에 떨어질 때까지 요크(86)의 상부 표면(120)을 따라 이동한다. 해제 스프링(112)은 해제 버튼(30)을 외측으로 밀고, 이는 상부 래치 암(118)을 아래쪽으로 피벗하여 상방향으로 제공된 오목부(122)와 결합하여, 도 8에 예시된 바와 같이 조직 클램핑 위치에 폐쇄 트리거(26)를 잠근다.
상기 래치 암(118)은 해제 버튼(30)을 안쪽으로 눌러 앤빌(18)을 해제하기 위해 오목부(122)로부터 나올 수 있다. 상세하게는, 상부 래치 암(118)은 제 2 베이스 섹션(52)의 핀(123) 둘레에서 상방향으로 피벗한다. 그 다음에 요크(86)가 폐쇄 트리거(26)의 복귀 운동에 반응하여 선단쪽으로의 이동이 허용된다.
발사 트리거 복귀 스프링(124)은 일단부가 제 2 베이스 섹션(52)의 핀(106)에 부착되고 다른 단부가 발사 트리거(28)의 핀(126)에 부착되어 핸들 부분(20) 내에 배치된다. 발사 복귀 스프링(124)은 핸들 부분(20)의 손잡이(24)로부터 멀어지는 방향으로 발사 트리거(28)를 편향시키기 위해 핀(126)에 복귀력을 가한다. 폐쇄 트리거(26)는 발사 트리거(28)의 표면(128)과 폐쇄 트리거(26)의 편향하는 정면(130)을 결합시켜 손잡이(24)로부터 멀어지게 편향된다.
상기 폐쇄 트리거(closure trigger)(26)가 손잡이(24)를 향해 이동할 때, 정면(130)은 발사 트리거(28) 상의 결합면(128)과 결합하여 발사 트리거(28)가 그 "발사" 위치로 이동하게 한다. 그 발사 위치에서, 발사 트리거(28)는 손잡이(24)에 대해 약 45°의 각도로 위치된다. 스테이플 발사 후, 스프링(124)이 발사 트리거(28)를 그 초기 위치로 복귀시킨다. 발사 트리거(28)의 복귀 운동 중에, 그 결합면(128)은 폐쇄 트리거(26)의 정면(130)에 대해 눌려 폐쇄 트리거(26)가 그 초기 위치로 복귀하게 한다. 정지 부재(132)가 폐쇄 트리거(26)가 그 초기 위치 너머로 회전하는 것을 방지하기 위해 제 2 베이스 섹션(52)으로부터 연장한다.
상기 외과용 봉합 및 절단 장치(10)는 왕복운동 섹션(134), 배율기(136; multiplier), 구동 부재(138)를 부가적으로 포함한다. 왕복운동 섹션(134)은 작동 부분(22)에 웨지 슬레드(도 6 내지 도 9에 도시않음)와 금속제 구동 로드(140; drive rod)를 포함한다.
상기 구동 부재(138)는 제 1 기어 랙 및 제 2 기어 랙(141, 142)을 포함한다. 제 1 노치(144)가 제 1 및 제 2 기어 랙(141, 142)의 중간에서 구동 부재(138)에 제공된다. 발사 트리거(28)의 복귀 운동 중에, 발사 트리거(28)의 치형부(146)는 스테이플 발사 후에 구동 부재(138)를 초기 위치로 복귀시키기 위해 제 1 노치(144)와 결합한다. 제 2 노치(148)는 금속제 구동 로드(140)를 발사되지 않은 위치에서 해제 버튼(30)의 상부 래치 암(118)에 잠그기 위해 금속제 구동 로드(140)의 선단부에 위치한다.
상기 배율기(136)는 제 1 및 제 2 일체형 피니언 기어(150, 152)를 포함한다. 제 1 일체형 피니언 기어(150)는 금속제 구동 로드(140)에 제공된 제 1 기어 랙(154)과 맞물린다. 제 2 일체형 피니언 기어(152)는 구동 부재(138)의 제 1 기어 랙(141)과 맞물린다. 제 1 일체형 피니언 기어(150)는 제 1 직경을 갖고 제 2 일체형 피니언 기어(152)는 제 1 직경보다 작은 제 2 직경을 갖는다.
도 6, 도 8, 도 9는 핸들 부분(20)을 출발 위치(개방 및 발사되지 않음), 클램핑된 위치(닫히고 발사되지 않음) 및 발사된 위치로 각각 예시한다. 발사 트리거(28)는 기어 세그먼트 섹션(156)을 구비한다. 기어 세그먼트 섹션(156)은 발사 트리거(28)가 움직이면 구동 부재(138)가 도 8에 도시한 제 1 구동 위치와 도 9에 도시한 제 2 구동 위치 사이에서 전후로 이동하도록 구동 부재(138)의 제 2 기어 랙(142)과 맞물린다. 조직이 클램핑되기 전에 스테이플이 발사되는 것을 방지하기 위해, 해제 버튼(39) 상의 상부 래치 암(118)은 금속제 구동 로드(140)가 도 6에 예시된 바와 같이 최-선단측 위치에 잠기도록 구동 부재(138)의 제 2 노치(148)와 결합한다. 상부 래치 암(118)이 오목부(122)에 떨어질 때, 상부 래치 암(118)은 제 2 노치(148)와 해제되어 도 9에 도시된 바와 같이 금속제 구동 로드(140)가 말단으로 이동할 수 있게 한다.
상기 구동 부재(138)의 제 1 기어 랙(141)과 금속제 구동 로드(140)의 기어 랙(154)이 배율기(136)와 결합하므로, 발사 트리거(28)가 움직이면 금속제 구동 로드(140)가 도 8에 도시된 제 1 왕복운동 위치와 도 9에 도시된 제 2 왕복운동 위치 사이에서 왕복운동하게 한다. 제 1 피니언 기어(150)의 직경이 제 2 피니언 기어(152)의 직경보다 크기 때문에, 배율기(136)는 발사 트리거(28)에 의해 구동 부재(138)가 이동되는 것보다 큰 거리로 왕복운동 섹션(134)을 이동시킨다. 제 1 및 제 2 피니언 기어(150, 152)의 직경들은 발사 트리거(28)의 행정 길이 및 이를 움직이는데 필요한 힘이 변할 수 있도록 변경될 수 있다. 핸들 부분(20)은 예시적이고 다른 작동 메커니즘이 사용될 수도 있다. 예를 들어, 폐쇄 및 발사 운동이 자동화 수단에 의해 생성될 수 있다.
외과용 절단 및 봉합 장치(10)의 말단 작동기(12)의 일 실시예가 도 18, 도 19, 및 도 23 내지 도 26에 더 상세히 예시되어 있다. 상술한 바와 같이, 핸들 부분(20)은 말단 작동기(12)를 작동하는 개별적이고 명확히 구분된 폐쇄 운동 및 발사 운동을 생성한다. 말단 작동기(12)는 유익하게는 이러한 개별적이고 명확히 구분된 폐쇄 및 발사(즉 봉합 및 절단)의 임상적 융통성을 유지한다. 부가적으로, 말단 작동기(12)는 임상의가 조직을 위치결정하고 클램핑한 후 발사하는 중에 닫힌 간격을 확실하게 유지하는 상술한 능력을 도입한다. 두 특징 모두는, 이 특징들이 적용되지 않는 경우 부적절한 양의 조직이 클램핑되는 상황들에 대해 적절한 간격을 보장하여 외과용 절단 및 봉합 장치(10)의 성능을 절차적으로 및 구조적으로 개선하며, 이 특징들이 적용되지 않은 경우 과다한 양의 조직이 클램핑되었던 상황들에서 클램핑을 개선한다.
도 10은 발사되지 않은 선단 위치의 발사용 바(14)와 함께 말단 작동기(12)에 설치된 본 발명의 스테이플 카트리지 실시예(300)를 예시한다. 스테이플 카트리지(300)는 테이퍼진(tapered) 외측 팁(306: tip)을 향해 카트리지(300)의 선단부(304)로부터 연장하는 기다란 슬롯(310)에 의해 분할된 카트리지 본체(302)를 갖는다. 다수의 스테이플 수용 채널(320a 내지 320f)이 스테이플 카트리지 본체(302) 내에 형성되고 6개의 측방향으로 이격된 길이방향 열(500, 502, 504, 506, 508, 510; row)로 배열되며, 기다란 슬롯(310)의 각각의 측면에 3개의 열이 배열된다. 스테이플(222)들은 스테이플-수용 채널(320a 내지 320f) 내에 배치된다. 도 10 및 도 11 참조.
상기 카트리지(300)는 도 11에 도시된 바와 같이 4개의 측방향으로 이격된 길이방향 열의 스테이플 드라이버들(330a, 330b, 370a, 370b)을 추가로 포함한다. "제 1" 내측 스테이플 드라이버(330a)들은 각각의 드라이버(330a)가 2개의 스테이플(222), 즉 채널(320b) 내에 하나 그리고 채널(320c) 내에 하나를 지지하도록 상응하는 채널(320b, 320c)들 내에 슬라이딩가능하게 장착되어 있다. 유사하게, "제 2" 내측 스테이플 드라이버(330b)들은 각각의 드라이버(330b)가 2개의 스테이플(222), 즉 채널(320d) 내에 하나 그리고 채널(320e) 내에 하나를 지지하도록 상응하는 채널(320d, 320e)들 내에 슬라이딩가능하게 장착되어 있다. "외측" 드라이버(370a, 370b)들은 스테이플-수용 채널들(320a, 320f) 내에 각각 슬라이딩가능하게 장착되어 있다. 각각의 외측 스테이플 드라이버(370a, 370b)들은 단일 스테이플(222)을 지지한다. 드라이버(370a)들은 본원에서 "제 1" 외측 스테이플 드라이버로 언급되고, 드라이버(370b)들은 본원에서 "제 2" 외측 스테이플 드라이버로 언급된다. 본원에서 제1 스테이플 드라이버는 제1 내측 스테이플 드라이버(330a) 및 제1 외측 스테이플 드라이버(370a)를 포함하고, 제2 스테이플 드라이버는 제2 내측 스테이플 드라이버(330b) 및 제2 외측 스테이플 드라이버(370b)를 포함한다.
도 12는 본 발명의 다양한 실시예들과 관련하여 사용될 수 있는 스테이플(222)을 예시한다. 스테이플(222)은 주요 부분(223)과 2개의 가지(225; prong)를 포함한다. 가지(225)들은 각각 길이 "P"를 갖고 주요 부분은 폭 "W"를 갖는다. 독자는 다양하고 상이한 타입의 스테이플이 사용될 수 있음을 이해할 것이다. 예를 들어, 혈관(vascular) 스테이플에 대해, "P"는 약 0.102인치(2.5908mm); 통상적인 스테이플에 대해, "P"는 약 0.134인치(3.4036mm); 두꺼운 조직 스테이플에 대해, "P"는 약 0.160인치(4.064mm)일 수 있다. 이러한 모든 스테이플에 대해, "W"는 약 0.120인치(3.048mm)일 수 있다. 다른 사이즈의 스테이플(222)이 후술하는 방식으로 사용될 수 있다.
기다란 슬롯(310)의 일 측면 상에 위치하는 내측 스테이플 드라이버(330a)들은 본원에서 "제 1" 내측 스테이플 드라이버로 언급되고, 기다란 슬롯(310)의 다른 측면 상에 위치하는 내측 스테이플 드라이버(330b)들은 본원에서 "제 2" 내측 스테이플 드라이버로 언급된다. 하기에 상술하는 바와 같이, 일 실시예에서, 제 2 내측 스테이플 드라이버(330b)는 카트리지 본체(302)의 각각의 채널에서의 배향을 제외하고는 제 1 내측 스테이플 드라이버와 동일하다.
도 13 내지 도 15는 스테이플(222)들을 지지 및 구동하기 위한 " 제 1" 내측 이중 드라이버(330a)의 일 실시예를 예시한다. 이들 도면에서 볼 수 있듯이, 스테이플 드라이버(330a)는 1차 드라이버 부분(340)과, 중앙 베이스 부재(360)에 의해 1차 드라이버 부분(340)에 연결된 2차 드라이버 부분(350)을 갖는다. 1차 드라이버 부분(340)은 드라이버(330a)가 각각의 채널 내에서 이동할 때 드라이버(330a)를 안내 및 안정화시키기 위해 카트리지 본체(302) 내의 상응하는 수직 연장 설상부(tongue; 도시않음)와 정합하는 구조의 홈(343)을 내부에 갖는 1차 드라이버 베이스(342)를 갖는다. 1차 드라이버 부분(340)은 1차 드라이버 베이스(342)로부터 상방향으로 돌출하는 제 1 후방 지지 컬럼(346)과 제 1 전방 지지 컬럼(344)을 추가로 갖는다. 제 1 전방 지지 컬럼(344)은 내부에 제 1 전방 스테이플-수용 홈(345)을 갖고, 제 1 후방 지지 컬럼(346)은 내부에 제 1 후방 스테이플-수용 홈(346)을 갖는다. 도 13 내지 도 15 참조. 제 1 전방 지지 컬럼(344)과 제 1 후방 지지 컬럼(346)은 서로 이격되어 있고 그리고 전체적으로 내부에 스테이플(222)의 주요 부분(223)을 지지하기 위한 제 1 스테이플 크래들(348)을 형성한다.
유사하게, 2차 드라이버 부분(350)은 2차 드라이버 베이스(352), 2차 전방 지지 컬럼(354), 및 2차 드라이버 베이스(352)로부터 돌출하는 2차 후방 지지 컬럼(356)을 갖는다. 2차 전방 지지 컬럼(354)은 내부에 2차 전방 스테이플-수용 홈(355)을 갖고, 2차 후방 지지 컬럼(356)은 내부에 2차 후방 스테이플-수용 홈(357)을 갖는다. 2차 전방 지지 컬럼(354)과 2차 후방 지지 컬럼(356)은 서로 이격되어 있고 그리고 전체적으로 내부에 다른 스테이플(222)의 주요 부분(223)을 지지하기 위한 제 2 스테이플 크래들(358)을 형성한다.
도 13 및 도 15에서 볼 수 있듯이, 중앙 베이스 부재(360)는 하기에 상술하는 바와 같이 상응하는 슬레드 캠에 의해 결합되는 구성의 후방을 향하는 각진 에지(362)를 갖는다. 도 13 및 도 14에서 볼 수 있듯이, 이 실시예에서, 제 2 드라이버 부분의 2차 전방 지지 컬럼(354)은 제 2 스테이플 크래들(358)에 지지된 스테이플(222)이 제 1 스테이플 크래들(348)의 스테이플(222)로부터 길이방향에서 오프셋되도록 제 1 후방 지지 컬럼(346)에 대해 배향된다.
독자는 제 1 내측 드라이버(330a)가 카트리지 본체(302)의 기다란 슬롯(310)의 일 측면 상에 위치한 상응하는 쌍의 채널들(320b, 320c)로 배향되게 각각 설치됨을 이해할 것이다. [제 1 내측 스테이플 드라이버(330a)로부터 기다란 슬롯(310)의 반대쪽 측면 상에 위치한] 제 2 내측 스테이플 드라이버(330b)는 그 각각의 각진 표면(363)이 상응하는 쌍의 채널들(320d, 320e)에 설치될 수 있게 카트리지(300)의 선단부(304)와 마주하도록 180°회전된 내측 드라이버(330a)를 포함한다. 그러므로, 이 실시예에서, 단 하나의 내측 드라이버 구성이 사용됨으로써 기다란 슬롯(310)의 각각의 측면에 있는 채널들에 대해 2개의 상이한 내측 스테이플 드라이버 구성을 필요로 하지 않는다.
도 16 및 도 17은 "제 1" 외측 스테이플 드라이버(370a)의 일 실시예를 예시한다. 이들 도면에서 볼 수 있듯이, 제 1 외측 스테이플 드라이버(370a)는 후방을 향하는 각진 부분(374)을 갖는 제 2 베이스(372)를 갖는다. 내부에 제 2 전방 스테이플-수용 홈(376)을 갖는 제 2 전방 지지 컬럼(375)이 제 2 베이스(372)로부터 상방향으로 돌출한다. 제 2 후방 지지 컬럼(377)도 제 2 전방 지지 컬럼(375)에 대해 이격된 관계로 제 2 베이스(372)로부터 상방향으로 돌출한다. 제 2 후방 지지 컬럼(377)은 그 안에 제 2 후방 스테이플-수용 홈(378)을 갖는다. 지지 컬럼들(375, 377)은 전체적으로 도 16 및 도 17에 예시된 바와 같이 그 안에 스테이플(222)을 지지하게 구성된 제 2 스테이플 크래들(379)을 형성한다. 스테이플 드라이버(370a)들은 각각의 채널 내에서 이동할 때 드라이버(370a)를 안내 및 안정화시키기 위해 카트리지 본체(302)의 상응하는 홈(도시하지 않음)에 수용되는 측방향 돌출 리브(371; rib)를 또한 갖는다.
독자는 제 1 외측 드라이버(370a)가 기다란 슬롯(310)의 일 측면 상의 상응하는 채널(320a)을 향하는 배향으로 설치됨을 이해할 것이다. [제 1 외측 스테이플 드라이버(370a)로부터 기다란 슬롯(310)의 반대쪽 측면 상에 위치한] 제 2 외측 스테이플 드라이버(370b)는 그 위의 각진 표면(374')이 카트리지 본체(302)의 상응하는 쌍의 채널(320f)에 설치될 수 있게 카트리지(300)의 선단부(304)와 마주하도록 180°회전된 외측 드라이버(370a)를 포함한다. 그러므로, 이 실시예에서, 단 하나의 외측 드라이버 구성이 사용됨으로써 기다란 슬롯(310)의 각각의 측면에 있는 채널들에 대해 2개의 상이한 외측 스테이플 드라이버 구성을 필요로 하지 않는다.
도 19 및 도 19a는 한가지 타입의 말단 작동기(12) 내에 장착된 본 발명의 스테이플 카트리지의 일 실시예의 단면을 예시한다. 이 실시예의 말단 작동기(12)는 도 23 내지 도 25에 예시된 타입의 "다단(stepped)" 앤빌(18)을 사용한다. 그러나, 다른 실시예에서, 앤빌의 바닥면은 평면이고 계단이 없다. 도 19a 및 도 23 내지 도 25에서 볼 수 있듯이, 앤빌(18)은 2개의 측방향 측면 부분(21, 23)과 같은 평면이 아니거나 또는 오프셋된 중앙 부분(19)을 갖는다. 따라서, 이 실시예에서, 카트리지(300)의 상부 표면(308)은 앤빌(18)이 폐쇄 위치일 때 앤빌(18)의 상응하는 부분들(19, 21, 23) 각각과 밀접하게 정합하는 구성인 2개의 측방향 측면 부분(309)과 오목한 중앙 부분(307)을 구비한다. 도 19a 참조.
도 24에서 볼 수 있듯이, 이 실시예에서, 앤빌(18)의 하부 표면(200)들은 카트리지(300)의 채널들의 열들에 상응하는 열들로 배열될 수 있는 일련의 성형 포켓(202)들을 구비한다. 즉, 포켓(202)들의 열(205)은 채널 열(500)에 상응할 수 있다. 포켓들의 열(207)은 채널 열(502)에 상응할 수 있다. 포켓(202)들의 열(209)은 채널 열(504)에 상응할 수 있다. 포켓(202)들의 열(211)은 채널 열(506)에 상응할 수 있다. 포켓(202)들의 열(213)은 채널 열(508)에 상응할 수 있다. 포켓(202)들의 열(215)은 채널 열(510)에 상응할 수 있다. 각각의 포켓(202)은 그 안에서 구동되는 스테이플 가지(225)들의 단부들과 접촉하는 구성인 하나 이상의 성형면(203)을 내부에 가져, 가지(225)들이 서로를 향해 내측으로 구부러지게 한다. 일 실시예에서, 각각의 포켓(202)은 도 14a에 도시한 바와 같이 배향된 2개의 교차하는 궁형(arcuate) 성형면(203)을 갖는다. 각각의 궁형 성형면은 최대 포켓 깊이 "Z"를 형성하는 정점(203')을 갖는다. 그러나, 다른 성형 포켓 구성도 사용될 수 있다.
도 18 및 도 19로 돌아가면, 일 실시예에서, 카트리지 본체(302)가 카트리지 트레이(224) 내에 장착된 것을 볼 수 있다. 도 19에 예시된 바와 같이, 카트리지 본체(302)는 2개의 내측 길이방향 연장 슬롯(390)과 2개의 외측 길이방향 연장 슬롯(392)을 갖게 형성된다. 슬롯(390, 392)들은 카트리지의 선단부(304)로부터 (도 10에 도시된) 테이퍼진 외측 팁(306)으로 연장한다. 이 실시예는 카트리지 트레이(224) 상에 슬라이딩가능하게 지지된 웨지 슬레드(400)를 추가로 포함한다. 웨지 슬레드(400)의 일 실시예는 한 쌍의 내측 슬레드 캠(410)을 포함하며, 하나의 내측 슬레드 캠(410)은 내측 길이방향 연장 슬롯(390) 중 하나에 상응하고 다른 내측 슬레드 캠(410)은 다른 내측 길이방향 연장 슬롯(390)에 상응한다. 도 19 참조. 웨지 슬레드(400)는 한 쌍의 외측 슬레드 캠(420)을 추가로 포함하며, 하나의 외측 슬레드 캠(420)은 외측 길이방향 연장 슬롯(392) 중 하나에 상응하고 다른 외측 슬레드 캠(420)은 도 19에 도시된 바와 같이 다른 외측 길이방향 연장 슬롯(392)에 상응한다. 조립되었을 때, 카트리지 트레이(224)는 카트리지 본체(302) 내측에서 드라이버들(330a, 330b, 370a, 370b)과 웨지 슬레드(400)를 잡아준다.
도 18에서 볼 수 있듯이, 기다란 채널(16)은 핸들 부분(20)에 말단 작동기(12)를 부착하기 위해 프레임(34)의 말단부 상에 있는 채널 고정 부재(228)를 수용하는 선단쪽에 배치된 부착 공동(226; attachment cavity)을 갖는다. 기다란 채널(16)은 앤빌(18)의 앤빌 피벗(232)을 피벗식으로 수용하는 앤빌 캠 슬롯(230)을 또한 갖는다. 프레임(34)을 둘러싸는 폐쇄 슬리브(32)는 말단에 제공되는 탭(234)을 포함하며, 상기 탭(234)은 앤빌(18) 상의 앤빌 피벗(232)에 가깝지만 말단쪽인 앤빌 특징부(feature)(236)와 결합하여 앤빌(18)이 개폐되게 한다. 발사 구동 부재(36)는 발사용 바(14)가 핀(240)들에 의해 발사 커넥터(238)에 부착되고, 다음에 발사 커넥터가 금속제 구동 로드(140)에 회전식으로 선단쪽에 부착되어, 조립되는 것으로 도시되어 있다. 발사용 바(14)는 그 안에 삽입되는 슬롯 가공된 가이드(239)에 의해 프레임의 말단부에서 안내된다.
도 20 내지 도 23은 본 발명의 웨지 슬레드(400)의 일 실시예를 예시한다. 도 20 및 도 23에서 볼 수 있듯이, 웨지 슬레드(400)는 내측 슬레드 캠(410)들 사이에서 연장하는 중앙 스페이서 부분(402)을 포함한다. 푸셔 블록(404; pusher block)이 발사용 바(14)의 중간 핀(46)과 결합하도록 중앙 스페이서 부분(402) 상에 형성된다. 내측 슬레드 캠(410)의 일 실시예의 측면 프로파일이 도 21에 예시되어 있다. 도면에서 볼 수 있듯이, 내측 슬레드 캠(410)은 바닥면(412), 바닥면(412)과 각도 "G"를 형성하는 제 1 캠 표면(414; camming surface), 상부 표면(416)으로 연장하는 제 2 캠 표면(415)을 갖는다. 일 실시예에서, 예를 들어, 각도 "G"는 35°일 수 있고, 각도 "G' "는 20°일 수 있다. 내측 슬레드 캠(410)의 높이[바닥면(412)과 상부 표면(416) 간의 거리]는 "제 1" 슬레드 캠 높이 "H"로 표현된다. 일 실시예에서, 거리 "H"는 약 0.173인치(4.3942mm)이고 상부 표면(416)의 길이는 실시예마다 다를 수 있다. 본 발명의 상세한 설명이 진행함에 따라 보다 명백해지듯이, 제 1 슬레드 캠 높이는 내측 슬레드 캠(410)이 작동 중에 앤빌(18)을 향해 상응하는 내측 드라이버(330a, 330b)들을 구동하는 수직 거리를 표현한다.
웨지 슬레드(400)는 도 20 및 도 23에 도시된 바와 같이 내측 슬레드 캠(410)들과 외측 슬레드 캠(420)들 사이에서 연장하는 측방향 스페이서 부분(406)들을 추가로 포함한다. 외측 슬레드 캠(420)의 일 실시예의 측면 프로파일이 도 22에 예시되어 있다. 이 실시예에서, 외측 슬레드 캠(420)은 바닥면(422), 바닥면(422)과 각도 "I"를 형성하는 제 1 캠 표면(424), 상부 표면(426)과 각도 "I' "를 형성하는 제 2 캠 표면(425)을 갖는다. 일 실시예에서, 각도 "I"는 35°일 수 있고, 각도 "I' "는 20°일 수 있다. 외측 슬레드 캠(420)의 높이[바닥면(412)과 상부 표면(416) 사이의 거리]는 "제 2" 슬레드 캠 높이 "J"로 표현된다. 일 실시예에서, 거리 "J"는 약 0.163인치(4.1402mm)이다. 제 2 슬레드 캠 높이는 외측 슬레드 캠(420)들이 작동 중에 상응하는 외측 드라이버들(370a, 370b)을 앤빌(18)을 향해 구동하는 수직 거리를 표현한다. 독자는 상술한 치수들이 일 실시예를 나타내는 것이고 다른 실시예들에서 변할 수 있음을 이해할 것이다.
도 23을 특히 참조하면, 스테이플 카트리지(300)의 일부분이 발사되지 않은 위치에서 스테이플 카트리지(300)의 몇몇 구성요소를 노출시키기 위해 그리고 오목부들(212, 214)과 같은 기다란 채널(16)의 부분들을 노출시키기 위해 제거되어 있다. 특히, (도 18에 도시된) 카트리지 본체(302)가 제거되어 있다. 웨지 슬레드(400)는 푸셔 블록(404)이 발사용 바(14)의 중간 핀(46; 도 23에 도시않됨)과 접촉하는 선단쪽의 발사되지 않은 위치에서 도시되어 있다. 웨지 슬레드(400)는 카트리지 트레이(224) 상에서 길이방향 슬라이딩 접촉하며, 웨지 슬레드(400)가 말단으로 이동할 때 단일 드라이버들(370a, 370b) 및 이중 드라이버들(330a, 330b)을 상방향으로 미는 웨지 슬레드 캠들(410, 420)을 포함한다. 그러므로, 드라이버들(330a, 330b, 370a, 370b) 상에 놓이는 스테이플(222; 도 23에 도시안함)들도 상방향으로 밀려 앤빌(18)의 앤빌 성형 포켓(202)들과 접촉하여 닫힌 스테이플들을 형성한다. 스테이플 카트리지(300)의 기다란 슬롯(310)과 정렬된 기다란 채널(16)의 채널 슬롯(45)도 예시되어 있다.
도 24는 말단 작동기(12)를 예시하며, 이는 후퇴한 폐쇄 슬리브(32)에 의해 개방 위치에 있고, 스테이플 카트리지(300)가 기다란 채널(16) 내에 설치되어 있다. 발사용 바(14)는 선단쪽 위치에 있고, 상부 핀(38)이 앤빌 포켓(40)과 간섭하지 않는 방식으로 정렬되어 있다. 앤빌 포켓(40)은 앤빌(18)의 길이방향 앤빌 슬롯(42)과 서로 통하는 것으로 도시되어 있다. 발사용 바(14)의 말단에 제공된 절단 에지(48)는 스테이플 카트리지(300)의 수직 슬롯(49)과 정렬되며 이로부터 선단쪽에서 제거되어 사용한 카트리지의 제거 및 발사되지 않은 카트리지의 삽입을 허용하며, 발사되지 않은 카트리지는 기다란 채널(16)에 "스냅-결합"할 수 있다. 상세하게는, 이 실시예에서, 스테이플 카트리지(300)의 연장 특징부들(316, 318; extension feature)은 기다란 채널(16)의 오목부들(212, 214; 도 23에 도시함) 각각과 결합한다.
도 25는 도 23의 말단 작동기(12)를 예시하며 모든 스테이플 카트리지(300)가 발사용 바(14)의 중간 핀(46)을 보이기 위해 제거되고 기다란 채널(16)의 일부분이 발사용 바 캡(44)을 노출하기 위해 채널 슬롯(45) 부근에서 제거되었다. 부가적으로, 샤프트(23)의 부분들이 발사용 바(14)의 선단쪽 부분을 노출하기 위해 제거되었다. 클램핑 중에 조직이 말단 작동기(12)로 너무 위쪽에 위치되는 것을 방지하는 작용을 하는 한 쌍의 대향하는 조직 정지부(244)가 피벗 근처에서 앤빌(18)로부터 아래쪽으로 돌출한다.
도 26은 발사용 바(14)가 발사되지 않은 위치인 폐쇄 위치의 말단 작동기(12)를 예시한다. 상부 핀(38)은 앤빌 포켓(40)에 있고 발사 중에 발사용 바(14)의 길이방향 말단 이동을 위해 앤빌 슬롯(42)과 수직방향에서 정렬된다. 중간 핀(46)은 슬레드 캠들(410, 420)이 이중 드라이버들(330a, 330b)과 단일 드라이버들(370a, 370b)을 각각 접촉하여 들어올려(lift) 이들을 앤빌(18)을 향해 상방향으로 구동하도록 웨지 슬레드(400)를 말단으로 밀 수 있는 위치에 있다.
도 14a, 도 15a, 및 도 19a를 참조하여 알 수 있듯이, 본 발명의 일 실시예에서, 앤빌(18)이 폐쇄 위치이고 그리고 내측 드라이버들(330a, 330b)이 카트리지 트레이(224) 상에 지지될 때, 앤빌(18)의 상응하는 성형 포켓(202)의 성형 표면(203)의 정점(203')과 제 1 스테이플 크래들(349)을 형성하는 제 1 스테이플-수용 홈(345, 347)의 바닥 간의 거리는 본원에서 제 1 스테이플 성형 거리 "A"라고 부른다. 앤빌(18)이 폐쇄 위치이고 그리고 내측 드라이버들(330a, 330b)이 카트리지 트레이(224) 상에 지지될 때, 앤빌(18)의 상응하는 성형 포켓(202)의 성형 표면(203)의 정점(203')과 제 2 스테이플 크래들(349)을 형성하는 제 2 스테이플-수용 홈(345, 347)의 바닥 간의 거리는 본원에서 제 2 스테이플 성형 거리 "B"라고 부른다. 일 실시예에서, 제 1 스테이플 성형 거리 "A"와 제 2 스테이플 성형 거리 "B"는 실질적으로 서로 같다. 다른 실시예에서, 이들 제1 및 제2 제 1 스테이플 성형 거리 "A"와 "B"는 서로 상이하다.
도 16a와 도 19a에 예시된 바와 같이, 앤빌(18)이 폐쇄 위치이고 그리고 외측 드라이버들(370a, 370b)이 카트리지 채널(224) 상에 지지되어 있을 때, 앤빌(18)의 상응하는 성형 포켓(202)의 성형면(203)의 정점(203')과 제 2 스테이플 크래들(379)을 형성하는 제 2 스테이플-수용 홈(376, 378)의 바닥 사이의 거리는 본원에서 "제 3 스테이플 성형 거리 "C"로 불린다.
도 27 및 도 28은 제 1 외측 드라이버(370a) 중 일부 상에 지지되는 스테이플들의 성형을 예시한다. 도 27에서, 웨지 슬레드(400)의 외측 슬레드 캠(420)들 중 하나가 외측 드라이버(370a)들 중 하나와 초기에 접촉한다. 웨지 슬레드(400)가 도 28의 화살표 "K"로 표현한 구동 방향에서 계속 이동할 때, 외측 슬레드 캠(420)은 외측 드라이버(370a)들이 지지된 스테이플(222)들을 앤빌(18)의 스테이플 성형 포켓(202)들 내로 들어가게 한다. 유사하게, 웨지 슬레드(400)가 구동 방향 "K"에서 구동될 때, 내측 슬레드 캠(410)들은 내측 드라이버들(330a, 330b)에 접촉하여 이 내측 드라이버들이 지지된 스테이플(222)들을 앤빌(18)의 상응하는 스테이플 성형 포켓(202)들 내로 들어가게 한다.
상술한 바와 같이, 조직 성분이 바뀌는 영역을 포함하는 몇몇 응용예에서, 절단선으로부터 가장 먼 거리에 있는 열의 스테이플들의 성형 (최종) 높이들이 절단선에서 가장 가까운 열의 스테이플들의 성형 (최종) 높이들보다 크게 되는 스테이플들의 열들을 형성하는 것이 바람직할 수 있다. 다른 응용예들에서, 단일 열의 스테이플들의 성형 높이들이 스테이플들 간에 증가하는 (또는 감소하는) 것이 바람직할 수 있다. 다른 임상적 장점은 최외측 열들의 스테이플들의 성형 높이들이 내측 열들의 스테이플들의 성형 높이들보다 큰 것이다. 본 발명의 다양한 실시예들은 모든 열에 동일한 스테이플들을 사용하면서 이러한 결과들을 제공할 수 있다.
본 발명의 상세한 설명이 진행됨에 따라, 스테이플들[외측 스테이플 드라이버들(370a, 370b)을 사용하여 성형되는 스테이플들]의 최외측 열(520, 530)들의 스테이플(222)들은 스테이플(222')로 이후 언급하고, 스테이플들[내측 스테이플 드라이버들(330a, 330b)을 사용하여 성형되는 스테이플들]의 최내측 열(522, 524, 526, 528)들의 스테이플들은 스테이플(222")로 이후 언급한다. 그러나, 스테이플(222', 222")들은 본 발명의 다양한 실시예들에 의해 성형되기 전에는 서로 동일하다. 즉, 스테이플(222', 222")들은 각각 동일한 가지 길이 "P"와 폭 "W"를 갖는다.
도 14a 내지 도 16a, 도 21 및 도 22를 참조하면, 상기 바람직한 효과들이 서로에 대한 스테이플 성형 거리들 "A", "B", "C" 및/또는 슬레드 캠 높이 "H", "J"를 바꿔 얻어질 수 있다. 본 발명의 일 실시예에서, 예를 들어, 내측 슬레드 캠(410)들 각각의 높이 "H"는 외측 슬레드 캠(420)들 각각의 슬레드 높이 "J"와 실질적으로 같다. 도 21 및 도 22 참조. 이 실시예에서, 제1 스테이플 성형 거리 "A"와 제2 제 1 스테이플 성형 거리 "B"는 서로 실질적으로 같지만, 제1 및 제2 제 1 스테이플 성형 거리 "A"와 "B"는 제3 스테이플 성형 거리 "C"보다 작다. 제 1 드라이버 베이스(342)의 바닥면(342')과 제 1 스테이플-수용 홈들(345, 347) 간의 거리 "D"는 제 2 드라이버 베이스(352)의 바닥면(352')과 제 2 스테이플-수용 홈들(356, 357)의 바닥 간의 거리 "E"와 실질적으로 같다. 또한 이 실시예에서, 외측 드라이버들(370a, 370b; 도 16)의 제 3 베이스(372)의 바닥면(373)과 제 2 스테이플-수용 홈들(376, 378)의 바닥 간의 거리 "F"는 거리 "D" 및 "E"보다 작다(도 15). 제3 스테이플 성형 거리 "C"가 제1 및 제2 스테이플 성형 거리 "A" 및 "B"보다 크므로, 외측 드라이버들(370a, 370b)에 의해 지지 및 성형되는 스테이플(222)들은 내측 드라이버들(330a, 330b)에 의해 지지 및 성형되는 스테이플들만큼 압축되지 않는다. 내측 드라이버(330b)들과 외측 드라이버(370b)들의 동일한 배치 및 사이즈를 사용하여 조직에 형성되는 절단선(600)과 기다란 슬롯(310)의 반대쪽 측면 상에서 동일한 결과가 얻어질 수 있음이 이해될 것이다. 다른 실시예에서, 제3 스테이플 성형 거리 "C"가 제1 및 제2 스테이플 성형 거리 "A" 및 "B"보다 크도록 드라이버들(370a, 370b)에 상응하는 성형 포켓(202)들의 깊이들을 바꿔 동일한 효과가 달성될 수 있다. 즉, 외측 드라이버들(370a, 370b)에 상응하는 성형 포켓(202)들의 깊이(도 16a의 거리 "Z")가 내측 드라이버들(330a, 330b)에 상응하는 성형 포켓(202)들의 깊이(도 14a의 거리 "Z")보다 클 수 있다.
도 29는 본 발명의 이 실시예를 사용하여 절단선(600)의 각각의 측면 상에 형성되는 스테이플들의 열들을 예시하며, 여기서 제1 및 제2 스테이플 성형 거리 "A" 및 "B"는 서로 같고 제3 스테이플 성형 거리 "C"는 제1 및 제2 스테이플 성형 거리 "A" 및 "B"보다 크다. 예를 들어, 제3 스테이플 성형 거리 "C"가 제1 및 제2 스테이플 성형 거리 "A" 및 "B"보다 0.020"(0.508mm) 크다면, 열들(520, 530)의 외측 스테이플(222')들의 성형 높이(도 30에 치수 "L"로 표현)는 열들(522, 524, 526, 528)의 내측 스테이플(222")들의 성형 높이(도 31에 치수 "M"으로 표현)보다 0.020인치(0.508mm) 크다.
제1, 제2 및 제3 스테이플 성형 거리 "A", "B", "C"가 실질적으로 같은 본 발명의 다른 실시예를 사용하여 같은 결과가 얻어질 수 있다. 그러나, 이 실시예에서, 내측 슬레드 캠(410)들의 각각의 높이(도 21에서 거리 "H")는 외측 슬레드 캠(420)들 각각의 높이(도 22에서 거리 "J")보다 크다. 그러므로, 내측 슬레드 캠(410)들의 높이 "H"는 외측 슬레드 캠(420)들의 높이 "J"보다 크므로, 내측 슬레드 캠(410)들은 외측 슬레드 캠(420)들이 상응하는 외측 드라이버들(370a, 370b)을 구동하는 것보다 앤빌을 향해 상응하는 내측 드라이버들(330a, 330b)을 더 멀리 구동한다. 이러한 구동 작용은 내측 드라이버들(330a, 330b)에 의해 지지된 스테이플들이 외측 드라이버들(370a, 370b)에 의해 지지된 스테이플들보다 더 많은 양이 압축되게 한다. 예를 들어, 거리 "H"가 거리 "J"보다 0.020인치 크면, 라인들(520, 530)의 스테이플(222')들의 성형 높이는 라인들(522, 524, 526, 528)의 스테이플(222")들의 성형 높이보다 0.020인치 크다.
본 발명의 또 다른 실시예를 사용하면, 스테이플(222')의 외측 열(520, 530)과 스테이플(222")의 내측 열(522, 528)이 내측 열(524, 526)의 스테이플(222")의 성형 높이보다 큰 높이를 갖게 형성될 수 있다. 도 32 참조. 이 결과는 제3 스테이플 성형 거리 "C"가 제1 스테이플 성형 거리 "A"보다 크게 하고 제1 스테이플 성형 거리 "A"가 제 2 스테이플 성형 거리 "B"보다 크게 하여 달성된다.
본 발명의 다른 실시예는 단일 열의 스테이플들의 성형 높이들이 변하는 것이 바람직한 경우 스테이플들을 설치하는데 사용될 수 있다. 이러한 한가지 배치가 도 33에 예시되어 있다. 도 33에서 볼 수 있듯이, 외측 열들(520, 530)의 스테이플(222')들의 성형 높이들은 각각의 열(520, 530)의 선단부들(521, 531)로부터 각각의 열(520, 530)의 말단부들(523, 533)로 이동할 때 증가한다. 이 효과는 각각의 연속적인 드라이버(370a, 370b)에 대해 제3 스테이플 성형 거리 "C"를 감소시켜 달성될 수 있다. 즉, 카트리지(300)의 선단부에 가장 가까운 드라이버(370a)가 일정 조건을 달성하기 위해 인접한 드라이버(370a 등)에 의해 달성되는 성형 거리 "C"보다 큰 제3 스테이플 성형 거리 "C"를 형성하는 사이즈를 가지며, 여기서 카트리지(300)의 선단부로부터 말단부로의 방향으로 이동하는) 각각의 연속적인 스테이플(222')이 더 큰 성형 높이를 갖는다. 이 결과는 각각의 드라이버(330a, 330b)에 의해 얻어지는 스테이플 성형 거리 "A" 및/또는 "B"를 유사하게 바꿔 열들(522, 524, 526, 528)의 스테이플(222')들에서도 얻어질 수 있다. 유사하게, 외측 열들(520, 530)의 스테이플(222')들의 성형 높이들은 각각의 열(520, 530)의 선단부들(521, 531)로부터 각각의 열(520, 530)의 말단부들(523, 533)로 이동할 때 감소될 수 있다. 이 결과는 각각의 연속적인 드라이버(370a, 370b)의 성형 거리를 증가시킴으로써 달성될 수 있다. 즉, 카트리지(300)의 선단부에 가장 가까운 드라이버(370a)가 일정 조건을 달성하기 위해 인접한 드라이버(370a 등)의 제3 스테이플 성형 거리 "C"보다 작은 제3 스페이플 성형 거리 "C"를 형성하는 사이즈를 가지며, 여기서 (카트리지의 선단부로부터 말단부로의 방향으로 이동하는) 각각의 연속적인 스테이플(222')은 더 작은 성형 높이를 갖는다. 도 34 참조.
사용시에, 외과용 절단 및 봉합 장치(10)는 도 1 및 도 2, 도 35 내지 도 41에 예시된 바와 같이 사용된다. 도 1 및 도 2에서, 장치(10)는 출발 위치에 있고, 기다란 채널(16)의 말단부로 스냅-결합되는, 발사되지 않고 만재된(fully loaded) 스테이플 카트리지(300)를 갖는다. 두 트리거(26, 28) 모두 전방에 있고 말단 작동기(12)를 투관침(trocar) 또는 다른 구멍을 통해 신체 공동으로 삽입한 후의 전형적인 것과 같이 말단 작동기(12)가 열려 있다. 그 다음에 장치(10)는 절단 및 봉합될 조직(248)이 도 35에 예시된 바와 같이 스테이플 카트리지(300)와 앤빌(18) 사이에 위치하도록 임상의에 의해 조작된다.
도 36 및 도 37을 참조하면, 그 다음에 임상의가 폐쇄 트리거(26)를 손잡이(24) 바로 근처에 위치할 때까지 선단측으로 움직여, 핸들 부분(20)을 폐쇄 및 클램핑된 위치에 잠근다. 말단 작동기(12)의 후퇴한 발사용 바(14)는 말단 작동기(12)의 선택적인 개폐를 방해하지 않고, 앤빌 포켓(40) 내에 놓인다. 앤빌(18)이 닫히고 클램핑되면, E-빔 발사용 바(14)는 말단 작동기(12)를 통해 발사되게 정렬된다. 특히, 상부 핀(38)은 앤빌 슬롯(42)에 대해 정렬되고, 기다란 채널(16)은 중간 핀(46)과 발사용 바 캡(44)에 의해 채널 슬롯(45) 둘레에 단단히 결합된다.
도 38 및 도 39를 참조하면, 조직 클램핑이 이루어진 후, 임상의는 발사 트리거(28)를 선단측으로 움직여 발사용 바(14)가 말단 작동기(12)로 말단쪽으로 이동하게 한다. 특히, 중간 핀(46)은 발사용 구동 슬롯(47)을 통해 스테이플 카트리지(300)에 들어가 스테이플(222; 도 38 및 도 39에 도시않음)들이 웨지 슬레드(400)를 경유해 앤빌(18)을 향해 발사되게 한다. 최외측 핀 또는 발사용 바 캡(44)은 중간 핀(46)과 함께 작용하여 조직을 절단하기 위해 발사용 바(14)의 절단 에지(48)를 슬라이딩식으로 위치결정시킨다. 2개의 핀(44, 46)은 앤빌(18)의 길이방향 앤빌 슬롯(42) 내에 발사용 바(14)의 상부 핀(38)을 또한 위치결정하여, 그 말단쪽 발사 운동에 걸쳐 기다란 채널(16)과 앤빌(18) 사이의 간격을 확실히 유지한다.
도 40 및 도 41을 참조하면, 임상의가 발사 트리거(28)를 폐쇄 트리거(26)와 손잡이(24)로 선단측으로 갈 때까지 계속 움직인다. 이에 의해, 스테이플(222)들의 모든 단부가 앤빌(18)과의 맞물린 결과 구부러진다. 발사용 바 캡(44)은 채널 슬롯(45)의 말단부를 향해 돌출하는 발사용 바 정지부(250)에 대해 정지된다. 절단 에지(48)는 조직을 완전히 가로지른다. 그 과정은 발사 트리거(28)를 해제한 다음 해제 버튼(30)을 누르면서 말단 작동기(12)를 개방하기 위해 폐쇄 트리거를 동시에 쥐어짜서 완료된다.
본 발명은 몇 개의 실시예의 설명에 의해 예시되었고 예시적인 실시예들이 상당히 상세히 설명되었지만, 이러한 세부사항들에 의해 첨부된 청구범위를 어떠한 의미에서도 한정하거나 제한하는 것은 출원인의 의도한 바가 아니다. 부가적인 장점 및 변경이 당업자에게 쉽게 보일 것이다. 본 발명의 다양한 실시예들은 상이하게 형성되는 (최종) 높이들을 갖는 스테이플들을 얻기 위해 단일 카트리지에 상이한 사이즈의 스테이플들을 사용할 것을 요구하는 종래의 스테이플 방법들에 대해 상당한 장점을 제공한다.
따라서, 본 발명은 내시경 시술 및 장치에 대해 설명되었다. 그러나, "내시경"과 같은 용어의 본원에서의 사용은 내시경 관(즉, 투관침)에만 관련하여 사용하기 위한 외과용 절단 및 봉합 장치에 본 발명을 한정하는 것으로 해석되지 않아야 한다. 대조적으로, 본 발명은 복강경 시술 및 개복 시술을 포함하지만 이에 한정되지 않는, 작은 절개부로 접근이 제한된 임의의 시술에서 용도를 찾을 수 있다고 생각된다. 또한, 본 발명의 다양한 스테이플 카트리지 실시예들의 독특하고 신규한 특징들은 본 발명의 진의 및 범위를 벗어나지 않고 다른 형태의 봉합 장치와 연계하여 사용될 때 용도를 찾을 수 있다.
본 발명의 일 특징은 상이한 성형 (최종) 높이들을 갖는 스테이플을 형성하는 능력을 도우면서 몇 개의 열 또는 다른 다수의 동일한 사이즈의 스테이플을 사용하는 봉합 장치를 위한 스테이플 카트리지를 제공하는 것이다. 몇몇 실시예에서, 최종 높이들은 인접한 스테이플 열들에 걸쳐 변할 수 있다. 다른 실시예에서, 스테이플들의 성형 높이들은 단일 열의 스테이플에서 스테이플들마다 변할 수 있다. 따라서, 본 발명의 다양한 실시예들은 다양한 성형 높이들을 갖는 스테이플들을 달성하기 위해 상이한 사이즈들의 스테이플들을 사용해야만 하는 다른 스테이플 카트리지 및 봉합 장치의 단점들에 대한 해결책을 제공한다.
Claims (22)
- 액츄에이터 및 절단부분을 갖는 봉합 장치(stapling device)와, 다수의 유사한 치수의 스테이플을 형성하기 위해 개방 위치와 폐쇄 위치 사이에서 선택적으로 이동가능한 앤빌(anvil)과 함께 사용하기 위한 스테이플 카트리지(staple cartridge)로서,상기 앤빌이 폐쇄 위치에 있을 때 상기 앤빌과 선택적으로 마주하는 관계(confronting relationship)가 되도록 상기 봉합 장치 내에 지지될 수 있는 카트리지 본체로서, 상기 액츄에이터 및 절단부분이 상기 카트리지를 통해 선단 단부에서부터 말단 단부로 길이방향으로 전진될 수 있도록 상기 액츄에이터 및 절단부분을 내부에 작동가능하게 수용하는 구성으로 된 상기 카트리지 본체와;상기 카트리지 본체 내에 이동가능하게 지지된 복수의 제1 스테이플 드라이버로서, 상기 복수의 제1 스테이플 드라이버는 상기 액츄에이터와의 연속적 상호작용시에 비작동 위치에서부터 작동 위치로 연속적으로 이동될 수 있고, 상기 제 1 스테이플 드라이버 각각은 스테이플을 지지하기 위해 제1 스테이플 지지 크래들(support cradle)을 내부에 형성하고, 상기 제1 스테이플 지지 크래들은 폐쇄된 앤빌의 대응하는 부분으로부터 제1 스테이플 형성 거리에 위치하는, 상기 복수의 제 1 스테이플 드라이버 및;상기 카트리지 본체 내에 이동가능하게 지지되며 상기 제1 스테이플 드라이버로부터 측방향으로 이격된 복수의 제2 스테이플 드라이버로서, 적어도 하나의 상기 제2 스테이플 드라이버는 상기 액츄에이터와의 연속적 상호작용시에 다른 비작동 위치에서부터 다른 작동 위치로 연속적으로 이동될 수 있고, 상기 제2 스테이플 드라이버 각각은 다른 스테이플을 지지하기 위해 제2 스테이플 지지 크래들을 내부에 형성하고, 상기 다른 스테이플은 성형되지 않을 때 상기 제1 스테이플 지지 크래들상의 상기 스테이플과 크기가 유사하고, 상기 제2 스테이플 지지 크래들 각각은 상기 제2 스테이플 지지 크래들에 해당하는 폐쇄된 앤빌의 다른 부분으로부터 제2 스테이플 형성 거리에 위치하는, 상기 복수의 제2 스테이플 드라이버를 포함하고,상기 제 2 스테이플 성형 거리는 상기 제 1 스테이플 성형 거리와는 상이한, 스테이플 카트리지.
- 제 1 항에 있어서,각각의 상기 제 1 스테이플 드라이버는 2개 이상의 상기 스테이플을 지지하는, 스테이플 카트리지.
- 제 2 항에 있어서,상기 제 1 스테이플 지지 크래들은 상기 제 1 스테이플 드라이버의 1차 드라이버 부분 안에 있고, 각각의 상기 제 1 스테이플 드라이버는 상기 1차 드라이버 부분에 부착된 2차 드라이버 부분을 추가로 포함하고, 상기 2차 드라이버 부분은 상기 앤빌이 폐쇄 위치에 있을 때 상기 앤빌의 다른 상응하는 부분으로부터 제3 스테이플 성형 거리에 위치하는 제 2 스테이플 지지 크래들을 형성하며, 상기 제 2 스테이플 지지 크래들은 상기 스테이플들 중 다른 하나를 그 위에 지지하는, 스테이플 카트리지.
- 제 3 항에 있어서,상기 제3 스테이플 성형 거리는 상기 제 1 스테이플 성형 거리와 같은, 스테이플 카트리지.
- 제 3 항에 있어서,상기 제3 스테이플 성형 거리는 상기 제 1 스테이플 성형 거리 및 상기 제 2 스테이플 성형 거리와는 상이한, 스테이플 카트리지.
- 제 1 항에 있어서,상기 하나 이상의 제 1 스테이플 드라이버는 제 1 열의 제 1 스테이플 드라이버들에 축방향으로 정렬된 복수의 제 1 스테이플 드라이버를 포함하고, 상기 하나 이상의 제 2 스테이플 드라이버는 상기 제 2 스테이플 드라이버의 제 2 열에 정렬된 복수의 제 2 스테이플 드라이버를 포함하는, 스테이플 카트리지.
- 제 6 항에 있어서,상기 제 1 스테이플 드라이버들의 제 1 열에서 상기 제 1 스테이플 드라이버들 중 하나의 상기 제 1 스테이플 성형 거리는, 상기 제 1 스테이플 드라이버들의 상기 제 1 열에서 상기 제 1 스테이플 드라이버들 중 다른 하나의 상기 제 1 스테이플 성형 거리와는 상이한, 스테이플 카트리지.
- 제 7 항에 있어서,상기 제 2 스테이플 드라이버들의 제 2 열에서 상기 제 2 스테이플 드라이버들 중 하나의 상기 제 2 스테이플 성형 거리는, 상기 제 2 스테이플 드라이버들의 제 2 열에서 상기 제 2 스테이플 드라이버들 중 다른 하나의 상기 제 2 스테이플 성형 거리와는 상이한, 스테이플 카트리지.
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Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US11/216,562 US7669746B2 (en) | 2005-08-31 | 2005-08-31 | Staple cartridges for forming staples having differing formed staple heights |
US11/216,562 | 2005-08-31 |
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EP (3) | EP1759812B1 (ko) |
JP (1) | JP5101063B2 (ko) |
KR (1) | KR101356585B1 (ko) |
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AU (1) | AU2006203685B2 (ko) |
BR (1) | BRPI0603660B8 (ko) |
CA (1) | CA2557026C (ko) |
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