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KR930002271B1 - 혈관내 약품공급 확장 카테테르 - Google Patents

혈관내 약품공급 확장 카테테르 Download PDF

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KR930002271B1
KR930002271B1 KR1019900007410A KR900007410A KR930002271B1 KR 930002271 B1 KR930002271 B1 KR 930002271B1 KR 1019900007410 A KR1019900007410 A KR 1019900007410A KR 900007410 A KR900007410 A KR 900007410A KR 930002271 B1 KR930002271 B1 KR 930002271B1
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tube member
lumen
distal end
catheter
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엘. 쇽키 릭
에이. 반 타쎌 로버트
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슈나이더(유 에스 에이)인코포레이티드
앨런 제이. 스피겔
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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
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A61M16/0454—Redundant cuffs
    • A61M16/0456—Redundant cuffs one cuff within another
    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0475—Tracheal tubes having openings in the tube
    • A61M16/0477—Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids
    • A61M16/0481—Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids through the cuff wall
    • 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
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • 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
    • A61M25/10—Balloon catheters
    • A61M25/104—Balloon catheters used for angioplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22082—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
    • 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
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • A61M2025/1013—Multiple balloon catheters with concentrically mounted balloons, e.g. being independently inflatable
    • 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
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes

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  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
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Abstract

내용 없음.

Description

혈관내 약품공급 확장 카테테르
도면은 본 발명에 따른 약품 공급 확장 카테테르의 확대 단면도.
* 도면의 주요부분에 대한 부호의 설명
18 : 가이드 와이어 22 : 외부 신장 슬리브(제2슬리브)
28 : 미세 구멍 30 : 내부 신장 슬리브(제1슬리브)
본 발명은 경피적인 관상 통과성 혈관 형성술(per-cutaneous transluminal angioplasty)을 수행하기 위한 장치 및 방법에 관한 것으로, 특히 치료될 병변의 확장과 동시에 치료 부위에 적당한 약품 또는 기타 액체 물질을 투여하기 위한 개선된 카테테르(catheter)장치에 관한 것이다.
1970년대 중반 이전에, 혈관내에서 죽종 또는 협착 병변을 치료하는 주요 방법으로는 장애물을 수술로 절개하였거나, 관상 동맥의 경우, 일반적으로 환자의 다리에서 추출되는 식육편으로 막힌 동맥을 통하게 하였다. 최근에는 에이, 구루엔직 의사에 의하여 진 일보된 과정에 따르면, 벨룬 카테데르(ballon catheter)를 적당한 위치에 유입시켜 혈관계(vascular system)를 통하여 치료될 병변 부위로 보내진다. 벨룬이 장애물또는 협착부에 근접하면, 확장액이 카테테르의 관강을 통하여 주입되며 장애물을 향하여 동일하게 팽창토록 기구를 확장시켜 폐쇄된 혈관벽을 펴거나 개방시킨다. 그러한 과정은 종래의 수술 과정보다 외상이 적다.
특허문헌에는 확장 카테테르 구조를 개선시키는 몇개의 특허를 포함하고 있다. 일반적으로, 이들은 비교적 작은 혈관을 치료할 수 있도록, 사용되는 재료, 로킹 특성 및 크기 감소의 개선을 제시하고 있다. 경피적인 관상 통과성 혈관 형성(PTCA)치료에 있어 때때로 치료된 혈관이 개방되지 않는 문제점이 여전히 존재한다. 사실 이 경우 약 33%는 12개윌내에 치료를 재개해야 할 필요가 있다. 어떤 약품은 몇몇 형태의 협착 병변의 교정을 줄이는데 효과적이라는 것이 공지되어 있다. 예를들면, 부드러운 근육 세포 성장을 억제하는 경향을 보인다는 평가를 받는 약품이 있다. 이 약품의 성질 때문에, 환약으로 주입되어 단지 혈류에 의하여 병변부까지 이송시키는 것은 바람직하지 않다. 이것은 필요한 투약에 있어서, 약품이 바람직하지 않은 부작용을 일으킬 수 있기 때문이다. 그러나 본 발명에 따르면, 약품이 병변에 직접 투약되면, 중요한 소량의 투약이 사용될 수 있으며 부작용을 최소화할 수 있다.
또한, 역학적 스텐트(stent)가 재협착을 억제하도록 치료 부위에 주입되어 적정 위치에 놓이게 되는 혈관형성술 또는 에써렉토미(atherectomy)방법이 제시되어 있다. 그러나, 스텐트를 설치하는 방법이 줄곳 고안되어 왔으나 직접적인 외과 처리보다 더 효과적인 것은 지금까지 없었다. 관상 동맥 치료의 경우에 외상 수술이 필요하므로, 벨룬 혈관 형성술의 장점이 허사가 된다.
따라서, 본 발명의 주요 목적은 개선된 확장 카테테르를 제공하는 것이다.
본 발명의 다른 목적은 재협착을 억제하도록 처리될 병변까지 직접 액체 약물 또는 기타 물질을 투약할수 있는 확장 카테테르를 제공하는 것이다.
본 발명의 또 다른 목적은 치료될 협착 병변이 펴지고 확장되는 동시에 플래크(plaque)제거 약품을 살포하거나 적당한 곳에 스텐트를 형성하는 물질을 살포하는 확장 카테테르를 제공하는 것이다.
본 발명의 또다른 목적은 외부 신장기가 방출할 약품을 공급받고 내부 신장기가 확장 및 약품 투약을 수행하도록 확장액을 공급받는 한쌍의 동심 신장기(concentric expander)를 말단부에 구비하는 복수개의 관강 확장 카테테르를 제공하는 것이다.
본 발명의 혈관내 약품 공급 확장 카테테르는 서로에 대해 동심으로 위치하는 3개의 신장된 가요성 플라스틱 튜브를 포함한다. 내부 및 외부 공동 신장기 슬리브가 동심 튜브의 말단부에 위치하며, 내부신장에 슬리브의 말단부가 최내튜브의 말단부에 결합되어 있는 반면에, 내부 신장기 슬리브의 기단부가 중간 튜브의 말단부에 결합된다. 다소 유사한 형태로 외부 공동 신장기 슬리브는 기단부에서 최의 튜브에 결합되고 말단부에서 최대 튜브의 말단부에 결합된다. 이런 방식에서 최외 슬리브의 내부가 최외 튜브의 관강과 유체 연통이 되는 반면, 최내 슬리브의 내부는 중간 튜브의 관강과 유체연통이 된다. 최외 슬리브는 정밀하게 제어되는 레이저 광선으로 형성된 미세 구멍 형태를 갖추게 된다. 확장액을 중간 튜브의 관강에 주입하고 액체형태의 적절한 약품 또는 기타 물질을 외부 튜브 부재의 관강에 주입하도록 3개의 동심으로 위치하는 카테테르의 기단부에 적절한 매니폴드(manifold)가 연결된다. 이런 방식에서 최내 슬리브의 내부에 압력이 증가하여 부풀리게 되면 미세 구멍을 통하여 약물 또는 물질을 분사하여 치료될 병변을 둘러싸도록 약제가 가압된다.
본 발명의 상기 목적, 특징 및 장점은 양호한 실시예의 상세한 후술, 특히 본 발명에 따르는 전체적, 부분적 단면으로 혈관내 약품 공급 카테테르를 도시하는 첨부 도면과 연관하여 고려하면 종래의 숙련된 사람에게 본 발명이 명백하게 될 것이다.
도면을 참고하면, 본 발명의 적합한 실시예를 포함하는 혈관내 약품 공급 확장 카테테르는 참고 번호 10으로 표시되고 있다. 도면에는 각각 참고번호 12,14 및 16으로 구별되는 동심 또는 축심으로 배치된 제1, 제2, 및 제3의 연장된 가요성 플라스틱 튜브 부재가 도시되어 있다. 세개의 튜브는 치료 부위의 혈관계기부를 쉽게 통과할 수 있는 크기의 최외 튜브(12)를 가진 대략 135cm길이가 일반적이다. 이러한 정렬은 병변 및 그 이상의 부위를 통과하는 가이드 와이어의 말단부를 가진 가이드 카테테르(비도시)를 통과하여 보내진 신장된 가이드 와이어(18)를 따라 통과하도록 된 오버 더 와이어 시스템(over-the-wire-system)으로 설명된다.
얇은 피막 슬리브 형태인 제1신장기 부재(22)가 말단부(20)에서 최외 튜브(12)의 외부 표면에 적절히 결합된다. 슬리브(22)의 말단부(24)는 말단부(26)에서 최내 튜브(16)의 외부 표면에 결합된다. 참고 번호 28과 같은 미세 구멍 형태는 신장기 부재(22)의 벽을 관통하여 형성된다. 신장기 부재(22)가 폴리에틸렌 테트라탈레이드 또는 염화 폴리비닐과 같은 쌍축성 방향 열경화 플라스틱 재료를 포함하고 있으며, 미세 구멍(28)은 정밀 레이저를 사용하여 형성될 수 있다.
내부 신장기 슬리브(30)가 외부 신장기 부재 또는 슬리브(22)의 내부에 위치한다. 그것은 말단부에서 중간 튜브(14)의 외부 표면에 결합된다. 다른 말단부는 최내 튜브(16)의 외부 표면에 결합된다. 중간 튜브의 관강(34)은 최내 신장기 부재(30)의 내부와 유체 연통 상태에 있는 반면에, 최외 튜브(12)의 관강(32)은 외부 신장기 부재(22)의 내부와 유체 연통 상태에 있는 것을 부분적인 단면도로부터 알 수 있다. 최내 튜브의 관강(36)은 도시된 것처럼 가이드 와이어(18)용으로 제공되어 있다.
관강(32,34)과 각각 통하는 한쌍의 포트(40,42)를 구비하는 성형 플라스틱 허브(38)가 카테테르 조립체의 기단부에 적절히 부착된다. 포트(40,42)는 본 발명의 양수인에게 양도된 구딘등의 특허출원 제4,723,938호에 도시된 주입기 형태와 같은 확장 기구의 연결을 용이하도록 하는 루어식 연결 형태일 수 있다.
가이드 와이어(18)를 수용하는 최내 튜브의 관강(36)에 연결된 보어(44)는 허브(38)의 기단부상에 위치한다. 가이드와이어(18)가 제거되면, 최내 튜브의 관강(36)은 국소 빈혈 역류를 억제하도록 치료 부위의 말단에 혈액을 살포하거나 조영제를 주입하는데 사용된다. 또는 최대 튜브(16)의 관강이 치료 부위에서 혈압 측정 방식으로 사용될 수 있거나 치료 과정동안 이탈될 수 있는 어떤 조직 입자를 빨아내는데 사용할 수 있다.
카테테르 몸체(12,14,16)는 혈관 형성 및 혈관 조영 카테테르를 제조하는데 일반적으로 사용되는 새로운 각종 재료로 제작될 수 있다. 일반적인 재료는 PVC나이론 및 폴리우레탄이다. 또한 가이드 와이어(18)는 특허 문헌에 공지된 기술에 따라 스테인레스 스틸로 제조될 수 있다.
사용시에 가이드 와이어(18)는 가이드 카테테르(비도시)를 통하여 치료될 병변을 가로질러 통상적으로 보내질 수 있다. 그후에 최대 튜브(16)의 말단부는 가이드 와이어의 기단부위에 )기워진 다음 신장기 부재(22,30)가 치료될 병변과 나란히 놓일때까지 가이드 와이어를 따라 전진한다. 도면에서 신장기 부재(22,30)는 확장된 모습으로 도시되어 있으며, 전송 과정동안 상기 신장기 부재는 튜브 부재(16)의 외부에 단단히 들어맞게 된다는 것을 알 수 있다.
카테테르의 말단부가 방사선 불투과성(radiopaque)표시 밴브(46)에 의하여 적당히 위치하면, 선택된 약품 또는 기타 물질이 기부 포트(40)와 관강(32)을 통하여 외부 신장기부재(22)의 경계로 주입된다. 약품의 주입은 외부 신장기부재(22)를 약간 팽창시킬 수 있으나 일반적으로 약제가 주입되는 곳에서의 압력은 상당한 양의 약제가 미세 구멍(28)을 통하여 배출되는 지점보다 낮다. 물질 공급 및 확장을 동시에 수행하도록 확장액이 포트(42)를 통하여 주입되고 나서 관강(34)을 통하여 신장기 슬리브(40)의 내부에 주입된다. 압력이 증가하면, 보통 7 내지 10기압에 이르므로, 신장기 부재는 예정된 최대 직경까지 팽창하게 되어, 포트(28)를 통하여 액체 물질을 특별한 약품 또는 기타 물질로 치료될 병변에 효과적으로 살포하도록 압력을 가한다. 또한 내부 슬리브(30)의 확장은 관강에 압력이 가해지는 결과가 되며, 약품 또는 기타 물질이 공급되면 혈관벽을 향하여 관강을 가압한다. 획장 압력과 약품 방출의 조화는 치료된 혈관에 장기간 개방성을 제공하는데 효과적인 것을 발전할 수 있다.
종래 기술에 있어서 통상적인 기술을 가진 자가 도면에 도시된 것처럼 3개의 동심 튜브를 사용하는 대신에 3개의 평행한 관강을 가진 만일 신장기 튜브가 확장 및 약품 공급을 제공하는데 사용될 수 있다는 것을알 수 있다.
일반적인 약품으로는 치료부위에 혈소판 응집을 억제하는 아스피린 또는 퍼센틴, 응괴 억제용 헤프린이나 프로스타그란딤, 또는 부드러운 근육질 세포 성장을 억제하는데 효과적인 기타 약품을 포함한다. 제너럴 일렉트릭 코포레이티드, 다우 코닝 코포레이티드 및 기타 회사에 의하여 판매되는 광 경학 생체 적합용 실리콘은 본 발명의 약품 공급 카테테르를 통하여 주입되어, 광 섬유를 통해 공급된 480nm의 가시광선으로 즉각 치료되고, 적절한 장소에 고형 튜브 스텐트를 형성하게 된다.
본 발명에 특허법에 따르고 그리고 새로운 원리를 적용하고 필요에 따라 특정 부품을 조립하여 사용하는것에 필요한 정보를 당업자에 제공하기 위하여 본원에 상세히 기술되었다. 그러나, 본 발명은 특히 다른 장치에 의하여 수행될 수 있으며, 장치의 세부사항 및 작동 과정에서의 다양한 수정은 본 발명의 영역으로부터 벗어나지 않고 이루어질 수 있다는 것을 이해할 수 있다.

Claims (4)

  1. 혈관내 약품 공급 확장 카테테르(10)에 있어서, 서로에 대해 동심으로 배치되고, 기단부, 말단부, 그리고 상기 기단부와 말단부 사이로 연장하는 관강을 각각 가지는 제1, 제2 및 제3의 신장된 가요성 플라스틱 튜브부재(12,14,16)와, 한 단부에서 상기 제2튜브 부재(14)의 말단부에 결합되고 다른 단부에서 상기 제3튜브부재(16)의 말단부(26)에 결합되며, 고 내부가 상기 제2튜브 부재(l4)의 관강(34)과 유체 연통하는 제1중공 신장 슬리브(30)와, 한 단부(20)에서 상기 제1튜브 부재(12)의 말단부에 결합되고 다른 단부(24)에서 상기 제3튜브 부재(16)의 말단부에 결합되며, 그 내부가 상기 제1튜브 부재(12)의 관강과 유체연통하고, 방사상으로 연장하는 형태의 미세 구멍(28)을 갖는 제2중공 신장 슬리브(22)와, 상기 제2튜브부재(14)의 관강(32)내에 확장액을 주입하고 상기 제1튜브 부재(12)의 관강(32)에 살포액을 주입하여, 상기 제1중공슬리브(30)가 상기 확장액에 의하여 확장될때, 상기 살포액이 상기 제2슬리브(22)내의 미세구멍(28)을 통하여 살포되는, 상기 제1, 제2 및 제3튜브부재(12,14,16)의 기단부에 연결된 매니폴드(38)를 포함하는 것을 특징으로 하는 혈관내 약품 공급 확장 카테테르.
  2. 제1항에 있어서, 상기 제3튜브 부재(l6)의 관강(36)을 통하여 삽입될 수 있는 가이드 와이어를 포함하는 것을 특징으로 하는 혈관내 약품 공급 확장 카테테르.
  3. 제1항에 있어서, 상기 제1,제2슬리브(30,22)는 쌍축으로 배향된 열가소성 필름으로 구성되는 것을 특징으로 하는 혈관내 약품 공급 확장 카테테르.
  4. 제3항에 있어서, 상기 필름은 폴리에틸렌 테레프탈레이트(PET)를 포함하는 것을 특징으로 하는 혈관내 약품 공급 확장 카테테르.
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