KR20110059645A - 의료 기기의 배치를 위한 수송 시스템 - Google Patents
의료 기기의 배치를 위한 수송 시스템 Download PDFInfo
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
- A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means
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- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
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- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09058—Basic structures of guide wires
- A61M2025/09083—Basic structures of guide wires having a coil around a core
- A61M2025/09091—Basic structures of guide wires having a coil around a core where a sheath surrounds the coil at the distal part
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09175—Guide wires having specific characteristics at the distal tip
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Abstract
본 발명에 의한 카데터는 카데터 상에 로딩된 의료 기기를 교호적으로 커버링하고 노출시키는 방식으로 대향 말단들에서 서로에 대하여 이동하는 동심 튜브로 연결된 쉬스를 포함한다. 쉬스의 일부분은 자체가 전환되도록 배열되어 다른 하나에 대한 하나의 튜브의 축 이동은 장치 위에서 또는 장치로부터 떨어져서 전환점을 동시에 이동시켜, 교호적으로 장치를 커버링하거나 노출시킨다.
Description
본 발명은 일반적으로 수송 카테터와 같은 최소 침습 수송 시스템 상에 의료 기기를 로딩하고 원위치로(in situ) 배치하기 위한 장치 및 방법에 관계한다.
경피적 대동맥판 대체(Percutaneous aortic valve replacement (PAVR)) 기술은 일반적으로 대동맥 질병, 특히 대동맥판협착증에 대한 치료의 대안으로서 굉장히 효과적이고 안정적이다. 역사적으로, 대동맥판 대체술은 수반되는 위험을 동반한 수술 및 고비용을 필요로 하여왔다. 외과수술적으로 수행된 결손된 심장 판막의 대체는 먼저 흉강의 절개하고, 환자를 체외 순환(extracorporeal circulation) 또는 말초 대동맥-정맥 심장 보조(peripheral aorto-venous heart assistance)하에 위치시키고, 일시적으로 심장을 멈추게하고, 결손된 판막을 노출시켜 잘라내고, 인공 판막을 그자리에 이식하는 것을 필요로 한다. 이러한 절차는 환자의 장기적인 입원기간 뿐 아니라 고비용 및 종종 고통스런 회복 기간이 필요하다는 단점을 갖는다. 비록 안전하고 효과적이어도, 외과수술적인 대체는 후기의 복잡성을 나타내고 비용이 현저히 높다. 그러나, 어떤 환자들에게 외과수술은 하나 또는 가능한 여러 가지 이유로 인하여 선택 사항이 아니다. 이와 같이 동맥 질병으로부터 고통받는 많은 환자들이 치료받지 못하고 있다.
개방된-심장 이식과 관련된 위험을 다루기 위해, 적게 침습적인 수단에 의한 심장 판막을 대체하는 장치 및 방법들이 개발되어왔다. 예를 들어, CoreValve, Inc. of Irvine, Californi는 중첩될 수 있고 확장가능한 지지체 프레임에 고정된 수송 카데터 내에 로딩될 수 있는 인공 판막을 개발하였다. 이러한 인공 기관은 현저하게 작은 환자의 위험 및 외상으로 맥관 구조를 통해 최소 침습적으로 배치될 수 있다. CoreValve 생체인공삽입물 및 다양한 구현예들은 미국특허 제 7,018,406호 및 7,329,278호와 미국공개특허 제 2004/0210304호 및 제 2007/0043435호에 기술되었다.
최소 침습적인 심장 판막 대체술을 사용함으로써, 환자의 회복은 외과 수술적인 기법에 비하여 대단히 촉진된다. CoreValve 장치의 경우에, 지지체 프레임은 니티놀과 같은 형상 기억 물질로부터 만들어진다. 다른 카데터-수송 판막 대체 시스템들은 스테인레스 스틸을 사용하거나 강성 프레임에 의존하지 않는다. 지금까지 성공적으로 기술된 바와 같이, 트랜스카데터(transcatheter) 절차를 사용한 경피적 대동맥 판막 대체는 벌룬을 사용하여 음성 루멘에 대한 판막 지지체를 확장하거나 제자리에 자가-확장(self-expanding) 지지체를 노출시켜 그 위치로 확장되도록하여 인공 판막을 질환이 있는 판막 부위에 대체되도록 이송시킴으로써 진행된다. 후자에서, 자가-확장 프레임은 타겟 위치에 도달할 때까지 이송되는 동안 쉬스된(sheathed)것이 유지된다. 유리하게도, 프레임은 카데터에 고정되어 쉬스가 철회될 때 미리 배치되는 것을 피한다. CoreValve 판막 인공 기관에서, 허브(hub)는 두 개의 부수적인 버튼과 함께 사용되는데, 각각의 둘레에 프레임 지그(frame zig)가 이송되는 동안 존재할 수 있다. 쉬스의 내부 방사상 힘은 프레임을 카데터에 대하여 압축되도록 하고, 측면 버튼들 둘레로 제자리에서 프레임 지그(zigs)들을 포함한다. 카데터는 일반적으로 적어도 두 개의 튜브들을 포함하고, 내부 튜브는 인공 기관을 운반하며, 외부 튜브는 쉬스를 운반하여 쉬스가 인공 기관에 대하여 이동하도록 허용한다.
전통적인 심혈관 개입 요법에 의하면, 트랜스카데터 장치 대체술은 정상 혈류 또는 선행의 혈류에 대하여 역행하여 진행될 수 있다. 대동맥 판막 대체를 위해, 대퇴부 동맥을 통한 진입은 엉덩이뼈, 하행 대동맥를 통한 포맷(format)에 역행하여, 아치(arch) 이상으로, 본래의 고리(annulus)로 진행된다.
임의의 경우에, 진입은 예를 들어, 좌측 쇄골하 동맥을 통하는 것과 같이 아치에 가깝게 만들어진다. 전방향 절차는 이송이 정맥 시스템을 통해 본래의 대동맥 고리로 교차랑으로(transeptally) 일어나도록 수행된다. 최근에, 트랜스아피컬(transapical) 절차가 수행되는데, 이에 의하면, 좌측 심실끝을 통해 카데터를 타겟 위치로 이송시킴으로써 심장 수술이 수행된다.
역행 전개에서, 일반적으로 카데터가 혈관 구조 내에서 전진되어 장치가 소정의 고리 지점에 위치되도록 하는 것이 바람직하다. 전개하의 임의의 구현예들에서, 바람직한 지점은 고리 그 자체이다. CoreValve 장치에 의해, 바람직한 지점은 고리에서 상행대동맥까지 그것의 상대적인 길이만큼 확장된다.
경대퇴동맥 접근에 있어서, CoreValve 장치가 바람직한 지점에 위치될 때, 쉬스는 장치의 유입 말단(바람직하게 본래 고리에 위치된)이 확장되는 지점으로 철회되어 본래의 판막 리플렛들(leaflets)을 결합시키고 방사상 표면 방향으로 민다. 쉬스는 인공 기관이 계속 확장되는 동안 근위 방향으로 계속 철회되고 쉬스가 허브 이어들(ears)에 고정된 인공 기관의 유출 부위을 덮을 때까지 노출된다. 절차가 수행되는 동안 전기적으로 가시적인 피드백에 기초한 이러한 과정의 진행되는 동안에 제자리에서의 장치의 축방향 위치의 임의의 재조정이 이뤄질 수 있다. 일단 위치되면 쉬스는 모두 철회되고 장치는 모두 제자리로 확장되고 카데터는 장치의 중앙을 통해 및 혈관계의 외부를 통해 철회된다. 인공 기관 장치를 사용하는 것이 가능하여 쉬스를 원위적으로 철회할 수 있는데 인공 기관 장치의 유출단(outflow end)을 최초로 배치하여, 이러한 배열은 쉬스에 원위적으로 연결된 카데터의 외부 튜브를 원위적으로 전진시키는 것을 필요로 한다.
트랜스페모럴(transfemoral) 후행 수송의 경우에, 외부 튜브가 좌심실로 돌출할 수 있는데, 이는 바람직하지 않다. 예를 들어, 트랜스아피컬(transapical) 수송과 같은 전행 접근에 있어서, 가역적인 상황이 존재한다. 쉬스를 원위 방향으로 전진시켜 본래의 최초 고리에서 인공 기관의 유입 말단을 노출시키는 것이 보다 바람직하다. 본래의 해부학적 구조는 이러한 원위 배치를 제공할 수 있는데, 이는 쉬스를 운반하는 외부 튜브가 아치를 향해 상행대동맥까지 전진하기 때문이다. 후행 접근과 같이, 일단 밸브 인공 기관이 충분히 배치되면, 카데터는 인공 기관의 중심을 통해 철회될 수 있고, 심장끝을 통해 제거된다.
쉬스내 및 외부로의 프레임의 움직임을 방해하는 마찰력들로 인하여 최소 침습적인 심장 밸브 대체에 의한, 쉬스(또는 캡슐)로의 자가-확장 밸브형 프레임의 로딩은 어려울 수 있다. 자가-확장 프레임에 수반되는 방사상 힘들은 쉬스에 대한 프레임의 축 이동이 일어나는 동안 쉬스의 내부벽에 반하여 프레임을 민다. 마찰은 원위 쉬스 내에서 이로부터 프레임을 매끄럽고 신뢰성 있게 로딩하고 배치하도록 인가될 수 있는 더 큰 축 힘으로 변환된다. 정확성이 요구될 때, 이와 같이 인가되는 더 큰 축 힘이 요구되는 마찰은 정확한 배치를 더 어렵게 만든다.
따라서, 로딩 및 배치가 일어나는 동안 마찰력의 억제 요소를 감소시키는 이송 카데터가 사용된 자가-확장 밸브형 프레임을 로딩하고 배치하는 적합한 시스템 및 방법에 대한 필요성이 여전히 존재한다.
본 발명은 환자에게 의료 기기를 최소 침습적으로 이송하기 위한 구현예들을 포함한다. 장치는 의료 기기를 교호적으로 커버링하고 노출시키는 방식으로 대향말단들에서 서로에 대하여 이동하는 동심 튜브들에 연결된 쉬스를 포함한다.
도 1A-C는 본 발명의 일 구현예에 의한 외부 튜브에 대한 내부 튜브의 일련의 축 이동을 보여주는 장치 이송 시스템의 단면도이다.
도 2A-C는 본 발명의 제 2의 구현예에 의한 외부 튜브에 대한 내부 튜브의 일련의 축 이동을 보여주는 장치 이송 시스템의 단면도이다.
도 3A 및 3B는 본 발명의 다른 구현예에 의한 외부 튜브에 대한 내부 튜브의 일련의 축 이동을 보여주는 장치 이송 시스템의 단면도이다.
도 2A-C는 본 발명의 제 2의 구현예에 의한 외부 튜브에 대한 내부 튜브의 일련의 축 이동을 보여주는 장치 이송 시스템의 단면도이다.
도 3A 및 3B는 본 발명의 다른 구현예에 의한 외부 튜브에 대한 내부 튜브의 일련의 축 이동을 보여주는 장치 이송 시스템의 단면도이다.
[발명의 요약]
본 발명은 환자에게 의료 기기를 최소 침습적으로 이송하기 위한 구현예들을 포함한다. 장치는 의료 기기를 교호적으로 커버링하고 노출시키는 방식으로 대향말단들에서 서로에 대하여 이동하는 동심 튜브들에 연결된 쉬스를 포함한다. 쉬스의 일부분은 배열되어 자체적으로 전환되어 전환점을 야기시킨다. 다른 하나에 대한 하나의 튜브의 축 이동은 전환점을 의료 기기 위로 또는 떨어져서 동시에 이동한다. 이러한 방식으로, 전환점과 장치(예를 들어, 자가-확장 프레임) 사이에 작은 마찰 맞물림(frictional engagement)이 생긴다.
고려된 바와 같이, 본원에 청구된 발명을 사용하도록 만들어진 몇몇의 서로 다른 구현예들이 있는데, 이들은 하나 이상의 전환점을 갖는 임의의 구현예들을 포함한다. 이러한 양상들 및 다른 양상들과 본 발명의 구현예들에 대한 이점은 장치 및 장치의 도면과 관련하여 하기에 보다 상세하게 기술될 것이고, 이러한 도시는 설명을 위한 것일 뿐 본 발명의 구현예들을 제한하지 않는다.
[바람직한 구현예의 상세한 설명]
도 1A-C를 참조하면, 원위단(16) 및 근위단(18)을 구비한 카데터(14)를 포함하는 의료 기기(12)에 대한 개선된 이송 시스템(10)의 일 구현예가 도시되었다. 도시된 도면에서, 예를 들어, 의료 기기(12)는 자가-확장 프레임(self-expanding frame)이다.
카데터(14)는 제 1의 내부 튜브(22) 및 외부 튜브(24)를 더 포함한다. 외부 튜브(24)의 원위단은 외부 튜브(24)에 부착된 캡(26)이다. 캡(26)은 바람직하게 그것의 원위 최극단(most-end)에서 매끄러운 원형의 표면을 갖도록 구성된다. 본원에 간략하게 기술된 바와 같이, 도 1A는 내부 튜브(22)의 원위단이 외부 튜브(24)의 원위단에 근접하게 위치되는 시스템(10)을 도시하고, 도 1B는 내부 튜브(22)가 근위 방향으로 당겨지는 것을 보여주며, 도 1C는 그것이 근위 방향으로 더 당겨지는 것을 보여준다.
카데터(14)는 쉬스(sheath)(30)를 더 포함하는데, 쉬스(30)는 바람직하게 산업적으로 이용되는 탄성인 가요성 물질로 만들어진다. 쉬스는 전체 또는 부분적으로 브레이드(braided), 직물화 또는 스티치(stitched ) 구조, 폴리머 또는 확장가능한 벌룬을 포함할 수 있다. 쉬스(30)의 제 1 말단(32)은 외부 튜브(24)의 원위단에 부착된 캡(26)의 외부 표면에 부착된다. 쉬스(30)의 제 2 말단(34)은 내부 튜브(22)의 원위단의 외부 표면에 부착된다. 도 1A에 도시된 바와 같이, 쉬스(30)는 의료 기기(12)를 타겟 위치로 이송하기 위하여 컬랩스된 위치(collapsed position)로 구속(constrain)하도록 구성된다.
쉬스(30)는 카데터(14)의 외부 표면상에서 그자체를 중첩하도록 구성되어 원위단의 근위에 전환점(36)을 형성한다. 또한, 쉬스(30)는 캡(26)의 매끄러운 원형의 원위 표면에 일치하도록 구성되어, 내부 튜브는 근위 방향으로 당겨지고, 쉬스는 캡 위로 매끄럽게 미끄러져 전환점(36)이 원위 방향으로 이동하도록 한다. 도 1A 내지 1C에 절차가 진행하는 것이 도시되었다. 쉬스(30)가 당겨지면 전환점(36)은 원위 방향으로 이동하고, 의료 기기(12)는 순차적으로 노출되어 그것을 원하는 만큼 확장시킨다.
도 1A-1C에 도시된 구현예에서, 내부 튜브(22)는 외부 튜브(24)의 원위캡(26) 이상으로 원위 방향으로 전진하는 것을 필요로 하지 않는다. 실제로, 카데터(14)는 의료 기기(12)의 타겟 위치보다 훨씬 원위 방향으로 위치될 필요가 없다. 따라서, 이러한 구현예들을 사용한 의료 기기의 배치는 다수의 가능한 방향 중 하나에서 혈관계를 통하여 트랜스루멘하게(translumenally) 만들어질 수 있다. 예를 들어, 대동맥 판막 치환술에 관하여, 의료 기기(12)는 확장가능한 밸브형 프레임이고, 카데터(14)는 트랜스페모럴(transfemorally) 하거나 트랜스아피컬(transapically)하거나 서브-클라비안 동맥을 통해 편리하게 유도된다. 장치(12)는 동맥 또는 정맥 시스템을 통해 전방으로 또는 후방으로 수송될 수 있다. 의료 기기(12)가 배치되면, 총 카데터(14)는 타겟 위치로부터 근위 방향으로 철회될 수 있다.
카데터(14)의 외부 튜브(24) 상에 의료 기기(12)를 로딩하는 것은 의료 기기를 외부 튜브(24)의 외부 표면 위로 컬랩싱(collapsing)하는 것을 수반하고, 내부 튜브(22)를 외부 튜브(24)에 대하여 원위 방향으로 이동하여 전환점(36)이 의료 기기(12) 위에서 근위 방향으로 이동하도록 한다. 전환점이 그것의 최극단 원위 지점에 이르면, 도 1A에 도시된 바와 같이, 카데터(14)는 의료 기기(12)를 이송하는데 사용될 수 있다. 자가-확장 프레임에 대하여 컬랩스(collapse)는 예를 들어, 그것의 온도를 낮춤으로써 유도될 수 있다. 벌룬 확장가능한 프레임에 대하여, 장치(12)는 다수의 알려진 방식 중의 하나에 의해 외부 튜브(24) 상에 크림프(crimped) 될 수 있다. 이러한 경우에, 외부 튜브(24)는 제자리 배치에 대하여 확장 벌룬을 포함할 수 있다.
도 1A-1C의 구현예를 변경한 것이 도 2 내지 2C에 동일한 요소들에 의해 도시되었다. 카데터(114)의 일 구현예에서, 쉬스의 제 2의 말단(34)은 내부 튜브(22)에 부착되어 내부 튜브(22)가 근위 방향이 아닌 원위 방향으로 효과적으로 전진(effective advancement)하는 것을 허용한다. 내부 튜브(22)가 원위 방향으로 유도되면서, 전환점(6) 또한 원위 방향으로 전진하고, 의료 기기(12)가 노출된다. 도 2A-2C의 구현예가 다양한 이송 방향에서 사용될 수 있고, 상술된 바와 같이 도 1A-1C의 구현예에서 이러한 카데터 구현예(14)를 사용한 의료 기기(12)에 대한 타겟 지점이 선호되어 내부 튜브(22)가 효과적으로 전진하기 위한 타겟 지점의 원위 방향에 충분한 방(room)이 존재한다.
도 3A 및 3B를 참조하면, 제 3의 구현예가 도시되었다. 의료 기기(212)는 카데터(214) 내에 쉬스되어 도시되었는데, 이는 상술된 카데터들(14, 114)에 유사한 요소들을 갖지만, 약간 다른 배열이다. 카데터(214)는 근위단(216) 및 원위단(218)을 갖고, 내부 튜브(222) 및 외부 튜브(224)를 포함하는데, 외부 튜브 및 내부 튜브는 서로에 대하여 이동가능하다. 칼라(collar)(226)가 내부 튜브(222)의 외부에 부착되었다. 의료 기기(212)를 커버링하는 쉬스(230)는 칼라(226)에 부착된 제 1 말단(232) 및 외부 튜브(224)의 외부쪽 원위단에 부착된 제 2 말단(234)을 구비한다. 쉬스(230)는 원위 위치에서 전환점(236)을 생성하도록 배열된다. 외부 튜브(224)는 근위 방향으로 수축되고, 전환점(236)은 근위 방향으로 이동하여 의료 기기(212)가 다른 구현예들에서 설명된 것과 동일한 방식으로 노출된다.
이러한 임의의 예시적인 구현예들 또는 이러한 구성들의 임의의 변경에 의해, 임상학자들은 내부 또는 외부 튜브들을 선택 조종하여 의료 기기를 노출시킬 수 있지만 , 의료 기기는 배치되는 동안 고정되지 않고, 타겟 지점을 향에 이동하는 결과를 가져온다는 것이 이해되어야 한다. 예를 들어, 제 1의 구현예에서, 내부 튜브(22)를 근위 방향으로 당기는 대신에 의료 기기(12)는 외부 튜브(24)를 원위 방향으로 전진시키는 것에 의해 노출될 수 있다. 결과는 동일하다: 전환점(36)은 원위 방향으로 전진된다. 이와 같이, 구현예 2A-2C의 외부 튜브(24)가 원위 방향으로 전진된 다른 튜브와 달리 근위 방향으로 당겨질 수 있고, 구현예 3A-3B의 내부 튜브(222)는 다른 튜브가 근위 방향으로 전진하는 것과 달리 원위 방향으로 당겨질 수 있다.
의료 기기를 로딩하고 배치하는데 전환 쉬스를 사용하는 것의 하나의 이점은 쉬스는 미끄럼 운동이 아니라 주로 롤링 운동(rolling motion)에 의해 교호적으로 의료 기기를 커버링하고 노출시킬 수 있어 의료 기기 및 쉬스 사이의 마찰을 줄일 수 있다는 것이다. 이는 쉬스를 수축시키는데 필요한 힘을 줄일 수 있어, 예를 들어, 수송 카데터의 압축 및 연장을 줄이는 것에 의해 배치 위치 이상으로 더많이 조절할 수 있게 한다. 또한, 의료 기기는 자가-확장 프레임에 봉합된 인공 기관 조직에 기초한 심장 판막을 포함하여 환자의 신체 온도는 프레임이 그것의 본래의 확장된 구성으로 복귀하도록 하는데, 이에 의해 쉬스에 반하여 외부힘이 가해진다. 배치되는 동안 쉬스와 의료 기기 사이의 마찰은 조직에 기초한 심장 판막 및 봉합자리를 손상시킬 수 있다. 따라서, 쉬스와 의료 기기 사이의 마찰을 미끄럼 운동이 아닌 롤링 운동을 사용하여 줄이는 것은 의료 기기의 손상을 줄이고, 의료 기기의 상태를 유지하는데 도움을 준다. 다른 경우에, 의료 기기는 약 또는 생물활성 물질로 코팅될 수 있고, 쉬스의 외부에 코팅된 스텐트(stent)를 미끄러뜨림에 의해 야기된 마찰은 약 또는 생물활성 물질의 일부에 의해 제거될 수 있다.
임의의 구현예들에서, 의료 기기에 접촉하는 쉬스의 표면은 점착성일 수 있어 점착성 표면이 의료 기기에 마찰에 의해 결합하도록 하여 의료 기기와 쉬스 사이의 미끄러짐을 줄일 수 있다. 표면은 예를 들어, 폴리우레탄 또는 다른 열가소성 엘라스토머와 같은 중합 물질을 표면에 적용하거나 점착성 물질로부터 표면을 제조하여 점착성으로 만들어질 수 있다.
전환시 쉬스 자체에 접촉하는 쉬스의 표면은 윤활성 코팅이 제공될 수 있거나 윤활성 물질로 만들어질 수 있다. 윤활성 코팅 또는 물질은 전환된 쉬스가 그 자체 위로 미끄러질 때 마찰을 감소시키는 예를 들어, PTFE, ePTFE, 친수성 물질 또는 임의의 다른 물질로 만들어질 수 있다. 소정의 경우에, 쉬스는 장력이 인가되면 쉬스의 연장을 최소화하도록 강화될 수 있다. 예를 들어, 모노 필라멘트 또는 섬유의 형태인 초고분자량 폴리에틸렌, 케블라(Kevlar), 탄소, 스틸, 티타늄과 같은 높은 인장 탄성 물질을 갖는 축 방향 장력 밴드들(미도시)은 쉬스 내 또는 쉬스 상에 통합될 수 있다.
작동에 있어서, 기술된 카데터들은 심장 판막의 이송에 대하여 특히 적합한데, 정확한 배치가 중요하다. 다른 중요하거나 덜-중요한 타겟 위치들 또한 고려된다. 자가-확장 동맥 판막 대체의 경우에 있어서, 카데터는 트랜스페모럴(transfemorally)하게, 교차랑(transeptally)으로, 트랜스아피컬(transapically)하거나 서브-클라비안 동맥을 통해, 다른 가능한 진입 방식으로 이송될 수 있다. 하나의 절차에 있어서, 카데터는 배치되어 밸브형 프레임은 타겟 위치와 전체적으로 정렬하여 위치된다; 예를 들어, 상행 대동맥(ascending aorta) 까지의 대동맥 고리. 프레임은 외부 튜브에 대한 내부 튜브를 전진시켜(도 2의 구현예에서) 또는 이와 반대로(도 1의 구현예에서) 또는 외부 샤프트의 수축(도 3의 구현예에서)에 의해 이송 방향에 따라 하나의 말단에서 다른 말단까지 노출될 수 있다. 프레임이 노출되면, 그것은 본래의 내막 라이닝(lining)을 결합하도록 외부로 확장되어 배치 정확도가 최고화된다. 쉬스가 충분히 제거되고 프레임은 충분히 확장되면, 카데터는 기능적인 인공 기관 밸브를 통해 철회될 수 있고, 환자로부터 제거된다.
비록 본 발명의 구현예들이 임의의 바람직한 구현예들 및 실시예들에 의해 기술되었지만, 구체적으로 기술된 구현예들과 다른 대안적인 구현예들 및/또는 본 발명 및 이들의 명백한 변경 및 동등물이 본 발명이 속하는 분야의 당업자들에 의해 사용될 수 있음이 이해되어야 한다. 특히, 본 발명에 의한 로딩 시스템 및 방법이 특히 바람직한 구현예들에 의해 기술되었지만, 숙련된 기술자들은 개시된 내용에 의해, 시스템의 임의의 이점, 특징 및 양상들이 다양하게 달리 적용될 수 있음을 알 수 있을 것이다. 또한, 본원에 기술된 본 발명의 다양한 양상들 및 특징들이 경험적으로 분리되고 서로 조합되거나 다른 하나에 대하여 치환될 수 있고 특징 및 양상들의 다양한 조합들 및 서브 조합들이 본 발명의 범주 내에서 만들어질 수 있다는 것이 고려된다. 따라서, 본원에 기술된 본 발명의 범위는 상술된 특정의 구현예들에 의해 제한되는 것이 아니고 청구항의 공정한 해석에 의해 결정되어야 한다.
Claims (19)
- 환자 내에서 타겟 위치로 의료 기기를 최소 침습적으로 수송하기 위한 장치로서, 상기 장치는
정지 위치에서 제 1 튜브(first tube) 위에 컬랩스된(collapsed) 의료 기기를 수용하기에 적합한 외부 표면을 구비한 제 1 튜브;
제 1 튜브에 대하여 이동가능하고 이와 함께 통합된(incorporated) 제 2 튜브(second tube); 및
제 1 튜브에 부착된 제 1 말단 및 제 2 튜브에 부착된 제 2 말단을 구비한 쉬딩(sheathing) 물질로서, 상기 쉬딩 물질의 일부는 장치 위에 로딩될 때 의료 기기의 적어도 일부분을 커버링할 수 있고, 제 1 및 제 2 튜브들은 동심으로 정렬되어 하나의 튜브가 다른 하나의 튜브에 대하여 이동할 때 쉬딩 물질 내에 전환점(inversion point)을 생성하는 쉬딩(sheathing) 물질;을 포함하고
상기 장치는 장치 위에 로딩될 때 하나의 튜브의 다른 하나에 대한 이동에 의해 전환점이 의료 기기에 대하여 이동하도록 구성되어 의료 기기가 타겟 위치에서 확장되는 것이 바람직할 때 의료 기기가 확장되도록 노출시키는 것을 특징으로 하는 장치.
- 제 1항에 있어서, 상기 제 1 튜브는 쉬딩 물질의 일부가 미끄러질 수 있는 매끄러운 표면을 구비한 캡(cap)을 포함하는 것을 특징으로 하는 장치.
- 제 1항에 있어서, 상기 쉬딩 물질은 장력이 물질에 인가될 때 연장을 최소화하도록 강화되는(reinforced) 것을 특징으로 하는 장치 .
- 제 1항에 있어서, 상기 쉬딩 물질은 전환될 때 그자체에 접촉하는 표면 위에 윤활성(lubricious) 코팅을 포함하는 것을 특징으로 하는 장치.
- 카데터 상에 로딩된 의료 기기를 이송하기 위한 방법으로서, 상기 방법은
제 2 동심 튜브에 대하여 제 1 튜브를 위치시켜 제 1 튜브에 부착된 제 1 말단 및 제 2 튜브에 부착된 제 2 말단을 구비한 쉬딩 물질을 적어도 하나의 전환점에 형성하는 단계;
제 1 방향으로 제 1 튜브를 제 2 튜브에 대하여 이동시켜 의료 기기가 전환점의 축 이동에 의해 쉬딩 물질의 일부로 적어도 일부분 커버링되는 단계;
카데터를 환자 내에 이송시켜 의료 기기를 소정의 치료 타겟 위치에 대하여 위치시키는 단계; 및
제 2 방향으로 제 2 튜브에 대하여 제 1 튜브를 이동시켜 기기를 확장하는 것이 바람직할 때 의료 기기를 노출시키는 방식으로 전환점을 이동시켜서 타겟 위치에서 의료 기기가 확장되도록 하는 단계를 포함하는 것을 특징으로 하는 방법.
- 제 5항에 있어서, 상기 제 1 방향에서 제 2 튜브에 대한 제 1 튜브의 이동은 제 1 튜브의 방향으로 전환점을 이동시키는 것을 특징으로 하는 방법.
- 제 5항에 있어서, 상기 제 1 방향에서 제 2 튜브에 대한 제 1 튜브의 이동은 제 1 튜브의 대향 방향으로 전환점을 이동시키는 것을 특징으로 하는 방법.
- 환자 내의 하나의 지점으로 의료 기기를 이송하기 위한 장치로서, 상기 장치는
원위 및 근위단;
제 1 및 제 2 튜브로서, 서로에 대하여 이동가능하고, 하나는 다른 하나 이내에 적어도 부분적으로 위치된 제 1 및 제 2 튜브들;
상기 튜브들 중 하나의 외부 표면 위에 의료 기기를 수용하기 위한 영역(region);
의료 기기를 고정하기 위한 가요성 쉬스(flexible sheath)로서, 상기 영역에 위치될 때, 쉬스는 자체적으로 중첩(folded)되어 외부 및 내부 위치들을 갖고, 외부 부분은 튜브들 중 하나에 직접 또는 간접적으로 부착되어 튜브의 이동에 의해 영역을 적어도 부분적으로 커버링하는 위치로부터 영역을 적어도 부분적으로 노출시키는 위치까지 쉬스의 외부 부분을 이동시키는 가요성 쉬스를 포함하는 카데터를 포함하는 것을 특징으로 하는 장치.
- 제 8항에 있어서, 상기 쉬스의 외부 부분은 상기 영역의 적어도 일부를 노출하도록 원위 방향으로 이동가능한 것을 특징으로 하는 장치.
- 제 8항에 있어서, 상기 쉬스는 내부 튜브에 직접 또는 간접적으로 부착되고 내부 튜브의 이동에 의해 상기 영역을 적어도 부분적으로 노출하도록 상기 쉬스의 외부 부분이 이동가능한 것을 특징으로 하는 장치.
- 제 10항에 있어서, 상기 내부 튜브는 근위 방향으로 이동가능하여 상기 영역을 적어도 부분적으로 노출시키도록 상기 쉬스의 외부 부분을 이동시키는 것을 특징으로 하는 장치.
- 제 10항에 있어서, 상기 내부 튜브는 원위 방향으로 이동가능하여 상기 영역의 적어도 일부를 노출시키도록 상기 쉬스의 외부 부분을 이동시키는 것을 특징으로 하는 장치.
- 제 8항에 있어서, 상기 쉬스는 상기 외부 튜브에 직접 또는 간접적으로 부착되고 상기 쉬스의 외부 부분은 외부 튜브의 이동에 의해 상기 영역을 적어도 부분적으로 노출시키도록 이동가능한 것을 특징으로 하는 장치.
- 제 1항에 의한 장치 및 의료 기기를 포함하는 키트(kit).
- 제 8항에 의한 장치 및 의료 기기를 포함하는 키트(kit).
- 제 14항에 있어서, 상기 의료 기기는 자가 확장 기기(self expanding device)인 것을 특징으로 하는 키트.
- 제 15항에 있어서, 상기 의료 기기는 자가 확장 기기인 것을 특징으로 하는 키트.
- 제 14항에 있어서, 상기 의료 기기는 심장 판막 인공 기관(heart valve prosthesis)인 것을 특징으로 하는 키트.
- 제 15항에 있어서, 상기 의료 기기는 심장 판막 인공 기관(heart valve prosthesis)인 것을 특징으로 하는 키트.
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US12/212,620 US8721714B2 (en) | 2008-09-17 | 2008-09-17 | Delivery system for deployment of medical devices |
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PCT/US2009/057315 WO2010033698A1 (en) | 2008-09-17 | 2009-09-17 | Delivery system for deployment of medical devices |
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US10321997B2 (en) | 2019-06-18 |
US9532873B2 (en) | 2017-01-03 |
KR101771428B1 (ko) | 2017-08-25 |
JP2012502751A (ja) | 2012-02-02 |
US8721714B2 (en) | 2014-05-13 |
EP2339988B1 (en) | 2016-12-21 |
JP5810333B2 (ja) | 2015-11-11 |
US20140214155A1 (en) | 2014-07-31 |
US20100069852A1 (en) | 2010-03-18 |
US20190298519A1 (en) | 2019-10-03 |
CN102159157A (zh) | 2011-08-17 |
WO2010033698A1 (en) | 2010-03-25 |
US20170071737A1 (en) | 2017-03-16 |
US11166815B2 (en) | 2021-11-09 |
CN102159157B (zh) | 2015-07-08 |
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