KR20030042441A - Sis와 진공 붕대의 복합체 및 상처 치유 방법 - Google Patents
Sis와 진공 붕대의 복합체 및 상처 치유 방법 Download PDFInfo
- Publication number
- KR20030042441A KR20030042441A KR1020027015662A KR20027015662A KR20030042441A KR 20030042441 A KR20030042441 A KR 20030042441A KR 1020027015662 A KR1020027015662 A KR 1020027015662A KR 20027015662 A KR20027015662 A KR 20027015662A KR 20030042441 A KR20030042441 A KR 20030042441A
- Authority
- KR
- South Korea
- Prior art keywords
- wound
- vacuum
- cover
- bandage
- sis
- Prior art date
Links
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Abstract
본 발명은 상처(12) 치료용 상처 치유 붕대(10)에 관한 것이다. 당해 붕대(10)는 상처 표면(16) 위에 놓이는 SIS층(14) 및 상처(12) 위에 놓이는 커버(18)를 포함한다. 당해 붕대(10)는 진공 공간(22)을 제공하기 위한 구조물(20)을 추가로 포함한다. 본 발명은 상처 치유 촉진방법을 추가로 제공한다. 당해 방법은 상기된 상처 치유 붕대(10)를 상처(12)에 적용하는 단계 및 혈액을 상처(12)로부터 SIS층(14)으로 조절 가능하게 끌어당기는 위해 진공 공간(22)내에 진공을 생성시키는 단계를 포함한다.
Description
발명의 배경
본 발명은 상처 치유에 관한 것이며, 보다 특히는 진공 붕대와의 복합체로 사용되는 SIS 상처 치유 커버의 제공에 관한 것이다. 본 발명은 장치와 장치 사용방법을 둘 다 고려한 것이다.
상처 치료시, 특히 청소되고 세정된 개방창 위에 SIS층을 직접 적용하는 경우, 소장 점막하조직(SIS)이 사용되는 것으로 알려져 있다. SIS는 미국 특허 제5,855,619호, 제5,866,414호, 제5,753,267호, 제5,762,966호, 제5,755,791호, 제4,902,508호, 제4,956,178호, 제5,275,826호, 제5,281,422호, 제4,352,463호, 제5,372,821호, 제5,445,833호, 제5,516,533호, 제5,573,784호, 제5,645,860호, 제5,641,518호, 제5,711,969호 및 제5,695,998호에 기재되어 있다. 이들 특허는 SIS의 특성을 기재하고 있다.
SIS는 광범위한 해부학적 결함 및 외상 손상을 복구, 지지 및 안정화하는 데 사용되는 천연 무세포 생물질로서 기재되어 있다[참조: Cook Online New Release at "www.cookgroup.com", 공급원: 쿡 바이오테크(Cook Biotech)]. SIS 물질은 사람 연조직에 이식시 이의 숙주의 특성을 모방하는 돼지 소장 점막하조직으로부터유도된, 조직 처리된 콜라겐 매트릭스이다. 또한, SIS 물질은 숙주 세포를 흡인하고 조직 리모델링을 지지하는 생화학적 조성을 지닌 3차원 구조의 천연 골격형 매트릭스를 제공한다. 외과용 연조직 복구 생물질 및 오아시스 상처 드레싱 생물질(Surgisis Soft Tissue Repair Biomaterial and Oasis Wound Dressing Biomaterial)[공급원: 미국 인디애나주 블루밍톤 소재의 쿡 바이오테크]은 부분적인 두께 피부 손상을 리모델링하는 데 유용하다. 오아시스 상처 드레싱은 단일 두께의 천공 쉬트로 제공된다. SIS는 상처 드레싱용으로 즉시 사용 가능한 것으로 여겨질 수 있다.
조직 리모델링에는 소장 점막하조직이 유용하나, 또 다른 점막하조직 공급원이 효과적인 것으로 알려져 있다. 이들 공급원은, 이에 제한되는 것은 아니나, 위, 방광, 소화기, 호흡기 또는 생식기의 점막하조직을 포함한다[참조: 미국 특허 제6,171,344호, 제6,099,567호 및 제5,554,389호]. 또한, 이들 다양한 점막하조직 물질은 소와 양을 포함하여, 돼지가 아닌 공급원으로부터 유도될 수 있는 것으로 알려져 있다. 또한, 기타의 콜라겐 매트릭스, 예를 들어, 고유층 및 치밀층이 공지되어 있다.
또한, 상처 치유를 가속화시키기 위한 진공 치료 붕대의 사용이 공지되어 있다. 진공 붕대는, 상처의 외부 주변에 밀봉용 커버가 있으며 그 아래에 진공이 상처 표면에 작용하도록 설정되어 있는 붕대이다. 상처 표면에 적용된 이러한 진공은 만성적인 상처의 치유를 가속화시킨다. 전형적으로, 삼출물을 상처로부터 끌어내기 위해 흡입관이 제공되며, 당해 흡입관은 커버 아래에 진공을 생성시키기 위해사용될 수 있다. 커버가 전형적으로 환자에게 보다 편안한 가요성 커버인 경우, 진공이 형성되는 공간을 제공하기 위해 다공질 포장이 커버 아래에 제공될 수 있다. 또한, 상처 치료 장치내의 가열기는 치유를 촉진시키는 것으로 알려져 있다. 미국 특허 제6,095,992호, 제6,080,189호, 제6,071,304호, 제5,645,081호, 제5,636,643호, 제5,358,494호, 제5,298,015호, 제4,969,880호, 제4,655,754호, 제4,569,674호, 제4,382,441호 및 제4,112,947호에는, 진공 및/또는 열 치료 붕대 및 장치의 특성이 입증되어 있다.
예를 들면, 미국 특허 제5,645,081호(이하, '081 특허)에 제시되어 있는 바와 같이, 조직 손상의 치료방법은 상처에 네가티브 압력을 적용함으로써 제공된다. 네가티브 압력은 조직 이동을 촉진시키기에 충분한 기간 및 정도로 제공되어 상처의 밀폐를 용이하게 한다. '081 특허에서의 도 1에는, 상처를 덮는 개방 기포 폴리에스테르 발포체 구획, 한쪽 말단의 발포체 구획으로 삽입되어 다른 쪽 말단의 진공 펌프에 부착되는 가요성 중공관, 및 발포체 구획 위에 위치하고 상처 주위 피부에 접착되도록 튜브 처리되어, 흡입 펌프 작동시, 진공을 생성시키는 밀봉부를 형성하는 접착제 쉬트가 도시되어 있다. '081 특허에는, 약 0.1 내지 0.99기압의 네가티브 압력이 사용되고, 당해 압력은 실질적으로 연속적일 수 있고, 이때 압력은 상처 드레싱을 바꿀때만 해제되는 것으로 추가로 교시되어 있다. 또한, '081 특허에는, 압력을 적용하는 기간과 적용하지 않는 기간을 교대로 하여 순환적으로 압력을 사용함이 교시되어 있다. 바람직한 양태에서, 압력은 적용 및 비적용한지 5분 이내에 적용된다.
본원이 허가된 바와 동일한 양수인에게 양도된, 계류 중인 다음 출원 또한 치유를 촉진시키기 위한 진공의 용도에 관한 것이다: 1999년 8월 5일자로 출원된 미국 특허원 제09/369,113호(발명의 명칭: 상처 치료 장치), 2000년 11월 29일자로 출원된 미국 특허원 제09/725,352호(발명의 명칭: 진공 치료법 및 상처 세정용 드레싱), 및 2000년 11월 29일자로 출원된 미국 특허원 제09/725,666호(발명의 명칭: 상처 치료 장치).
각종 선행 기술 참조물에는, 진공 붕대의 가치 또는 만성적인 상처의 표면에 대한 진공의 제공이 교시되어 있다. 몇몇 러시아어판 문헌에는, 진공 치료법의 효능이 입증되어 있다. 상처 치유를 촉진시키기 위한 진공의 적용 용도가 거론되어 있는, 이러한 선행 기술 문헌의 예는 다음과 같다:Vacuum therapy in the treatment of acute suppurative diseases of soft tissues and suppurative wound, Davydov, et al. Vestn. Khir., 1988년 9월 (이하, "1988년 9월자 문헌");Pathenogenic mechanism of the effect of vacuum therapy on the course of the wound process, Davydov, et al. Khirurigiia, 1990년 6월 (이하, "1990년 6월자 문헌"); andVacuum therapy in the treatment of suppurative lactation mastitis, Davydov, et al., Vestn. Khir., 1986년 11월 (이하, "1986년 11월자 문헌").
러시아 문헌들은 상처 배액물을 치유용 진공 치료의 사용과 구별하며, 진공 치료가 전통적인 절개 배액법보다 상처 세정을 보다 빠르게 하고 해독을 보다 신속하게 한다고 보고하고 있다. 1986년 11월자 문헌에는, 외과 수술시 0.8 내지 1.0기압에서 20분, 이어서 0.1 내지 0.15기압의 진공에서 1.5 내지 3시간으로 1일 2회의 진공 치료법 프로토콜이 기재되어 있다. 이들 러시아 문헌에는, 네가티브 압력의 사용이 치유를 촉진시킨다고 교시되어 있다. 또한, 러시아 문헌에는, 이러한 진공법을 사용하면 상처내 미생물의 수가 감소될 수 있다고 교시되어 있다. 1990년 6월자 문헌에는, 진공 치료법이 상당한 항박테리아 효과를 제공한다고 교시되어 있다. 1990년 6월자 문헌에는, 상처 주위 영역으로의 혈액 유동을 단계별로 상향시켜 염증 병변에 도달하는 백혈구의 수를 증가시킨다고 교시되어 있다. 또한, 러시아 문헌에는, 진공 치료법을 사용한 국소적 혈액 순환의 개선이 교시되어 있다. 1988년 9월자 문헌에는, 상처 영역으로의 향상된 혈액 유입량이 회복 과정을 강화시킨다고 교시되어 있다. 1990년 6월자 문헌에는, 진공 치료법이 혈장, 조직간 유체, 및 상처로의 림프의 이동을 촉진시킨다고 교시되어 있다. 1990년 6월자 문헌에는, 결합 조직의 세포성 및 비세포성 원소가 진공 치료법으로 치료된 상처에서 2배 정도 신속하게 나타난다고 교시되어 있다. 그 이후의 문헌 및 특허는 진공 치료법으로 수득된 이점을 추가로 발달시켰다. 따라서, 선행 기술은 진공 붕대의 이점 및 가치를 교시하고 있다.
발명의 요지
본 발명에 따르면, SIS와 진공 치료법의 이점을 조합하여 상처 층으로부터 SIS 물질로의 유체 흐름을 조절 및 증대시키는 상처 치유 붕대가 제공된다. 따라서, 본 발명은 유체를 주위 조직으로부터 상처 위에 놓인 SIS층으로 조절 가능하게끌어당김으로써 SIS의 치유 및 재조직 특성을 증대시키는 방법이다.
본 발명은 SIS와 상처 층 위에 공간을 제공하는 구조물을 포함하며, 이 공간에서 진공은 혈액을 상처 층으로부터 SIS로 유동시키도록 발달된다. 또한, 당해 방법은 상처 층으로부터 SIS로의 최적 혈류를 제공하기 위한 진공 수준 및 진공 적용 시간을 조절하는 것으로 사료된다.
바람직한 양태에서, 상처 치유 붕대는 상처 층과 접촉되도록 놓여지는 SIS층을 포함한다. 위에서 언급된 바와 같이, 상처 치유 붕대는 SIS층과 구조물 및 SIS층 위에 놓인 커버 사이에 진공 공간을 제공하도록 SIS층 위에 놓인 구조물을 추가로 포함한다. 당해 커버는 환자의 상처 주위 피부에 결합되어 밀봉 환경을 제공한다. 진공 공급원은 구조물에 의해 생성된 진공 공간과 상호교류하기 위한 상처 커버물에 결합된다. 진공 공급원은 밀봉 환경내에 진공을 생성시켜 혈액을 상처 층으로부터 SIS층을 통해 상향으로 끌어당겨 치유 공정을 촉진시키는 데 사용된다. 진공 흡입은 혈액을 SIS층으로 끌어당기는 데 충분한 수준, 예를 들어, 125mmHg에서 존재할 수 있다. 그러나, 진공 흡입의 변화 수준 및 진공 적용 시간 동안의 변화 프로토콜은 본 발명의 범주내에 속하는 것으로 여겨질 수 있다.
또 다른 양태에서, 공간 제공 구조물은 다공질 패드 또는 망상 패드이거나, SIS층으로부터 커버로 연장되어 있는 공기 통로를 지닌 기타의 구조물이다. 또 다른 양태에서, 공간 제공 구조물은 발포체 환일 수 있거나, 커버가 충분히 경질인 한, 커버 그 자체일 수 있다.
따라서, 본 발명의 한 가지 양상에서, 상처 위에 놓이도록 형성된 콜라겐 매트릭스, 상처 위에 놓여서 상처 주위에 밀봉 환경을 제공하도록 배치되고 진공 공급원과 상호교류하는 커버 및 콜라겐 매트릭스와 커버 사이에 놓이고 진공 공간을 제공하도록 배치된 구조물을 포함하는 상처 치유 붕대가 제공된다. 바람직한 양태에서, 콜라겐 매트릭스는 점막하조직 층이다.
본 발명의 또 다른 양상에서, 상처 위에 놓이는 SIS층 및 SIS층과 커버 내면 사이에 진공 공간을 제공하기 위해 상처와 SIS층 위에 놓이도록 배치되는 커버(이때, 진공 공간은 진공 공급원에 연결 가능하다)를 포함하는 상처 치유 붕대가 제공된다.
본 발명의 또 다른 양상은 상처 위에 놓이는 SIS층, 상처 위에 진공 공간을 제공하기 위해 상처 위에 놓이는 커버, 및 SIS층과 커버 사이의 진공 공간을 한정하는 구조물을 포함하는 상처 치유 붕대를 제공하는 단계 및 혈액을 상처로부터 상처 위에 놓인 SIS층으로 조절 가능하게 끌어당기기 위해 진공 공간내에 진공을 생성시키는 단계를 포함하는, 상처 치유 촉진방법을 포함한다.
본 발명의 또 다른 양상은 SIS층을 상처 표면에 적용시키는 단계, 지지체 구조물을 SIS층 위에 놓는 단계, 진공 공간을 한정하기 위해 커버를 상처, SIS층 및 지지체 구조물 위에 놓는 단계, 커버를 진공 공급원에 연결시키는 단계 및 진공 공간내에 진공을 생성시키는 단계를 포함하는, 상처 치유 촉진방법에 관련된다.
본 발명의 추가의 양상은 콜라겐 매트릭스를 상처 표면에 적용시키는 단계, 상처 및 콜라겐 매트릭스와 상호교류하는 진공 공간을 생성시키는 단계 및 혈액을 상처로부터 콜라겐 매트릭스로 끌어당기기에 충분한 정도 및 기간 동안 진공 공간내에 진공을 생성시키는 단계를 포함하는, 상처 치유 촉진방법에 관련된다.
본 발명의 최종 양상은 상처 접촉용 점막하조직 층, 다공질 패드 및 진공 공급원과 상호교류하도록 배치되어 있는, 상처 주위 밀봉용 커버를 포함하는 상처 치유 촉진용 키트(kit)이다.
상세한 설명은 특히 첨부된 도면을 참조로 한다:
도 1은 청소된 상처와, SIS층, 다공질 패드 또는 충전재, 및 상처 치유 붕대 커버를 나타내고 진공 공급원에 이르는 튜브와 상호교류하는 상처 치유 붕대 커버를 추가로 나타내는 상처 치유 붕대의 단면도를 나타낸 것이다.
도 2는 SIS층의 천공을 나타내는, 도 1에 도시되어 있는 SIS층의 평면도를 나타낸 것이다.
도 3은 또 다른 청소된 상처와, SIS층, 진공 공간을 제공하기 위한 벽면 구조물, 커버물, 및 커버 아래에 놓여서 한쪽 말단의 진공 공간과 다른쪽 말단의 진공 공급원과 상호교류하도록 위치된 진공 튜브를 포함하는 또 다른 상처 치유 붕대의 단면도를 나타낸 것이다.
도 4는 청소된 상처 위의 또 다른 상처 치유 붕대를 나타내고 SIS층, 진공 공급원과 상호교류하는 진공 공간을 한정하는 환형 구조물, 및 당해 구조물 위에 위치한 커버를 포함하는 붕대를 나타내는, 본 발명의 또 다른 양태의 단면도를 나타낸 것이다.
도 5는 진공 공급원과 상호교류하는 진공 공간을 한정하기 위한 반경질 벽면 구조물을 포함하는 붕대를 나타내는, 본 발명의 또 다른 양태의 단면도를 나타낸 것이다.
상처 치유 붕대(10)는, 도 1 내지 도 5에 도시되어 있는 바와 같이, 청소된 상처(12)용으로 제공된다. 도 1을 참조하면, 붕대(10)는 상처(12)의 상처 표면(16)에 인접해 있는 소장 점막하조직(SIS)층(14)을 포함한다. 붕대(10)는 상처(12) 위에 놓여지는 커버(18)와, 진공 공간(22)을 생성시키기 위해 SIS층(14)과 커버(18) 사이에 위치한 구조물(20, 120, 220 또는 320)을 추가로 포함한다. 당해 커버(18)는 환자의 상처(12) 주위 피부(24)의 일부에 결합되어 상처(12), SIS층(14) 및 구조물(20, 120, 220 또는 320)을 밀봉 환경내에서 밀폐시킨다. 붕대(10)는 진공 공간(22)이 진공 공급원(26)과 상호교류하도록 하는 수단을 추가로 포함한다. 따라서, 상처 치유 붕대(10)는 SIS층(14)의 치유성을 진공 치료법에 의해 제공된 가속화와 조합한다.
상처 표면(16)에 직접 적용되는 SIS층(14)은 천공될 수 있어서 SIS층(14) 아래에 유체 집적물을 제공한다. 이러한 천공물(28)은, 예를 들어, 도 2에 도시되어 있다. 장치는 피부 이식편을 천공시키는 데 유용하며, 이러한 장치는 또한 SIS층(14)을 천공시키는 데 사용될 수 있는 것으로 사료된다. SIS층(14) 중의 이들 천공(28)은 혈액을 상처(12)로부터 SIS층(14)으로 상향 이동시키고 세포를 부착시켜 SIS층(14)의 SIS 골격에서 조직 성장을 개시시킨다.
또한, SIS층(14)은 하나의 단일 SIS 쉬트 또는 다중 SIS 쉬트를 포함하도록 형성될 수 있다. 다중 SIS 쉬트를 포함하는 SIS층(14)의 경우, 쉬트는 서로에 대해 임의의 배향 수로 위치될 수 있다. 또한, SIS층(14)에 대한 본 명세서의 범주내에서 붕대(10)에 사용하기에 합당한 두께를 지닐 수 있다. 또한, 당해 기술분야에서는 점막하조직의 다중 단편을 융합시킴으로써 보다 큰 점막하조직 쉬트를 형성할 수 있다[참조: 미국 특허 제5,711,969호]. 바람직한 양태에서, SIS층(14)은 상처에 맞는 크기로 되고 가용성이어서 SIS층(14)이 임의의 복합적인 상처 또는 상처 표면에 합치될 수 있다. 또한, 상처를 신선, 냉동 또는 동결건조 형태로 제공된 SIS로 치료하는 것도 알려져 있다. 동결 건조된 SIS는 건조형으로 사용될 수 있거나, 사용 전에 수화될 수 있다.
일부 임의 양태에서, SIS층(14)을, 예를 들어, 도 1에 도시된 바와 같이, 상처 표면(16)에 고정시키기 위해 청소된 상처 표면(16)과 SIS층(14) 사이에 생물학적 아교(30)가 사용된다. 사용되는 생물학적 아교(30)의 한 가지 유형은, 예를 들어, 섬유소 밀봉재일 수 있다. 그러나, 본 명세서의 범주내에는, SIS층(14)을 상처 표면(16)에 고정시키기에 충분한 임의 유형의 생물학적 아교가 포함된다.
SIS는 돼지 소장 점막하조직을 동정하기 위함이다. 본원의 SIS에 대해, 소장 점막하조직은 소, 양 및 기타 온혈 포유동물을 포함한 기타 동물 공급원으로부터 수득될 수 있는 것으로 여겨질 수 있다. 또한, 각종 조직으로부터의 기타 점막하조직 공급원은 조직 리모델링에도 효과적인 것으로 알려져 있다. 이들 공급원은, 이에 제한되는 것은 아니나, 위, 방광, 소화기, 호흡기 및 생식기의 점막하조직을 포함한다. 이러한 점막하조직 유도된 매트릭스는 고도로 보존된 콜라겐, 글리코프로테인, 프로테오글리칸 및 글리코스아미노글리칸을 포함한다. 또한, 기타의 콜라겐 매트릭스가 생물학적 골격으로 작용할 수 있는 것으로 알려져 있다. 따라서, 바람직한 양태는 SIS를 사용하나, 기타의 콜라겐 매트릭스가 본 발명의 범주내에서 사용될 수 있는 것으로 이해된다.
붕대(10)의 구조는 SIS층(14)과 커버(18) 사이에 진공 공간(22)을 형성하도록 제공된다. 구조물은 상처 표면(16)과 SIS층(14)으로의 공기 통로를 제공하면서 커버(18)를 지지한다. 도 1에 도시된 바와 같이, 바람직하게는 구조물은, 기류 통로(도시되지 않음)가 패드(20) 전반에 걸쳐서 연장되어 있는 망상 또는 다공질 충전재 또는 패드(20)이다. 바람직하게는, 패드(20)는 다소 가요성이어서 임의의 복합적인 상처 또는 상처 표면에 합치되고 환자에게 편안하도록 한다. 또한, 바람직하게는, 구조물의 두께는 제공되는 상처의 모든 부분에 접근하기에 적합한 진공을 제공하도록 선택된다. 또한, 바람직하게는, 가요성 망상 패드(20)의 두께(t)는 약 1 내지 2cm이다. 망상 또는 다공질 패드(20)는 외과 의사에 의해 SIS층(14)보다 크고 상처(12)보다 더 크게 절단될 수 있다.
다공질 패드(20)가 상기되어 있으나, 본 명세서의 범주내에는, SIS층(14)과 커버(18) 사이에 공간을 생성하는 기능을 하고 공기를 상처(12)로부터 유동시켜서 네가티브 압력을 상처 표면(16)으로 전송하는 임의의 구조물이 포함된다. 도 3에 도시된 바와 같이, 구조물(120)은 거즈(gauze)형일 수 있거나, 도 4에 도시된 바와같이, 커버(18)를 SIS층(14)과 이격된 관계로 위치시키는 발포체 환(220) 또는 기타의 환일 수 있다. 당해 환(220)은 환(220)의 내벽(221)에 의해 한정된 구멍을 포함한다. 따라서, 진공 공간(22)은 SIS층(14), 커버(18), 및 환(220)의 내벽(221)에 의해 한정된다.
또한, 예를 들면, 도 5에 도시된 바와 같이, 구조물은 SIS층(14) 위의 커버(18)를 지지하는 경질 돔(dome) 또는 바람직하게는 반경질 돔(320)일 수 있다. 반경질 돔(320)은 환자의 상처(12) 주위 피부에 인접하게 놓이는 저부 부재(322), SIS층(14)으로부터 통상적으로 이격되어 있는 상부 부재(324), 및 상부 부재(324)를 SIS층(14)과 이격된 관계로 지지하기 위한 중간 부재(326)를 포함한다. 또한, 예를 들어, 반경질 돔(320)은 일반적으로 돔 형태일 수 있다. 다공질 패드(20), 발포체 환(220) 및 반경질 돔(320)과 같은 예가 구조물에 대한 예로서 제공되었으나, 붕대(10)에 대한 본 명세서의 범주내에는, 진공 공급원(26)과 상호교류하기 위해 구조물을 SIS층(14) 위와 커버(18) 아래에 제공하는 임의의 공간이 포함된다.
붕대(10)의 커버(18)는 공간 제공 구조물 위에 놓여 있어서 구조물, SIS층(14) 및 상처(12)를 충분히 밀폐시킨다. 커버(18)는 환자의 상처(12) 주위 피부(24)에 결합된다. 예를 들어, 커버(18)는 진공 덮개를 제공하기 위해 상처(12) 주위의 피부(24) 표면에 부착되는, 얇고 투명한 비다공질 접착제 쉬트일 수 있다. 커버(18)를 피부(24)에 결합시키기 위한 접착제(33)는 도 1 및 도 3 내지 도 5에 도시되어 있다. 예를 들면, 테가덤(Tegaderm)[공급원: 미국 미네소타주 세인트 폴 소재의 쓰리엠 헬쓰 케어 리미티드(3M Health Care Ltd.)] 등의 제품이커버에 적합할 수 있다. 그러나, 본 명세서의 범주내에는 임의의 적합한 불투과성 또는 반투과성 비다공질 쉬트가 포함된다. 환자의 편의를 위해서는 가요성 또는 반경질 쉬트가 바람직하나, 유리 돔 등의 경질 커버가 본 발명의 범주내에 속한다. 경질 커버가 사용될 경우, 경질 커버는 진공 공간을 제공하도록 배치될 수 있기 때문에, 개개의 공간 제공 구조물은 필요하지 않다.
상처(12) 및 상처 표면(16)으로의 혈류를 조장하기 위해, 상처 치유 붕대(10)의 진공 공간(22)은 진공 공급원(26)과 연결되어 있다. 예를 들면, 진공 공간(22)과 진공 공급원(26)과의 유체 상호교류를 위해 진공 튜브(32)가 제공될 수 있다. 도 1에 도시된 바와 같이, 진공 튜브(32)는 커버(18)에 결합되어 진공 공간(22)과 상호교류한다. 튜브(32)의 제1 말단(40)은 커버(18)의 구멍에 결합된 접관(34)을 포함한다. 도식적으로 도시된 바와 같이, 튜브(32)의 제2 말단(42)은 진공 공급원(26)에 결합된다.
또 다른 양태에서, 예를 들어, 도 3 내지 도 5에 도시되어 있는 바와 같이, 튜브(32)는 커버(18) 아래에서 진공 공간(22) 속으로 놓인다. 커버(18)는 튜브(32) 주변에 밀봉되어 있어서 진공이 적절하게 기능하도록 밀봉 환경을 생성시킨다. 진공은 공간내에 배치되고 과량의 상처 배액물을 상처로부터 끌어내도록 배치된 흡입관에 의해 제공될 수 있다. 상처 드레싱과 진공 공급원 사이의 유체 연결 시스템의 또 다른 유형은 미국 특허 제4,969,880호에 기재되어 있다. 또한, 튜브(32)의 제1 말단(40)이 도 3 및 도 4에서는 구조물(120 또는 220)내에 위치하는 것으로 도시되어 있으나, 제1 말단(32)은 SIS층(14) 위에 직접 놓일 수 있는 것으로 이해된다. 또한, 튜브(32)는, 구멍이 제1 말단(32)에 인접하여 길이 방향으로 분포되어 있는 잭슨-프랫(Jackson-Pratt)형 배수관일 수 있는 것으로 이해된다.
진공은 조절된 시간 동안 진공 공간(22)내에 제공될 수 있다. 예를 들어, 초기에 진공은 충분한 시간 동안 적용되어 혈액을, 예를 들어, 125mmHg 이하로 SIS층(14)으로 끌어당긴다. 본 발명은 진공 정도 및 적용 시간에 대한 상이한 프로토콜의 발달을 고려한 것으로 여겨질 수 있다. 또한, 진공은 과량의 상처 배액물을 운반하도록 위치되고 구성된 천공 튜브에 의해 제공될 수 있다.
상처(12) 치료시, 관리자는 먼저 상처 표면(16)을 세정하여 준비한다. 일단 상처 표면(16)이 준비되면, 붕대(10)를 상처에 적용한다. SIS층(14)을 상처(12) 위에 놓아 준비된 상처 표면(16)을 피복한다. 구조물(20, 120, 220 또는 320)을 SIS층 위에 놓아 진공 공간을 한정하고, 커버(18)를 상처(12), SIS층(14) 및 구조물(20) 위에 놓는다. 커버(18)를 진공 공급원(26)에 연결시킨다. 최종적으로, 혈액을 상처로부터 SIS층(14)으로 끌어당기기에 충분한 정도 및 기간 동안 진공 공간(22)을 흡입시킨다. 임의로, 생물학적 아교(30)가 붕대(10)를 적용하기 전에 상처 표면(16)에 놓일 수 있다.
진공은 임의의 정도 또는 기간 동안 적용되어 상처로부터 SIS층으로의 혈액 유입을 촉진시킬 수 있다. 바람직하게는, 진공은 0.1 내지 0.99기압, 보다 바람직하게는 0.1 내지 0.15기압으로 적용될 수 있다. 한 가지 양태에서, 치유하는 동안, 진공은 필수적으로 계속 적용된다. 또 다른 양태에서, 진공은 적용되는 기간과 적용되지 않는 기간이 교대로 사용되며, 구조물 및 커버는 진공이 적용되지 않는 기간 동안 제거될 수 있다. 교대 기간은 1일 1회 또는 2회로 수 일 동안 적용될 수 있다. 또 다른 양태에서, 네가티브 압력은 적용 기간과 비적용 기간의 5분 이내에 적용된다.
SIS층은 상처 속으로 통합될 수 있고 재구조화되어 주변 조직을 재조합할 수 있는 것으로 알려져 있다. 따라서, 진공 적용의 정도 및 기간이 다양할 수 있더라도, 바람직한 양태에서 SIS는 치료 기간 동안 상처 표면에 잔존한다. 임의 양태에서, SIS가 상처 속으로 통합되므로 추가의 SIS층이 첨가될 수 있다. 추가의 층은 국소화된 통합 영역 위에 놓이는 보다 작은 단편일 수 있거나, 또는 진공이 SIS층으로의 혈류를 촉진시키므로 상처 표면의 크기와 합치되는 충분한 크기의 단편일 수 있다.
따라서, 한 가지 양태에서 본 발명은 상처 표면을 준비하는 단계, 붕대를 상처에 적용하는 단계(이때, 붕대는 상처 위에 단단히 놓인 SIS층 및 상처 위의 커버를 가지며, SIS층은 상처와 SIS층 사이에 진공 공간을 한정한다), 및 진공 공간을 흡입시켜 혈액을 상처로부터 SIS층으로 끌어당기는 단계를 포함하는, 상처 치료방법이다.
본 발명은 특정한 양태를 참조로 하여 상세히 기재되었으나, 다음의 청구의 범위에 기재되어 있고 한정되어 있는 본 발명의 범주 및 취지내에서 변경 및 변형된다.
Claims (38)
- 상처 위에 놓이도록 형성된 콜라겐 매트릭스,상처 위에 놓여서 상처 주위에 밀봉 환경을 제공하도록 배치되고 진공 공급원과 상호교류하는 커버 및콜라겐 매트릭스와 커버 사이에 놓이고 진공 공간을 제공하도록 배치된 구조물을 포함하는 상처 치유 붕대.
- 제1항에 있어서, 콜라겐 매트릭스가 점막하조직 층을 포함하는 붕대.
- 제2항에 있어서, 점막하조직 층이 SIS층인 붕대.
- 제3항에 있어서, SIS층이 하나 이상의 SIS 쉬트를 포함하는 붕대.
- 제3항에 있어서, SIS층이 천공되어 있는 붕대.
- 제1항에 있어서, 콜라겐 매트릭스를 상처에 대해 고정시키기 위해 상처와 콜라겐 매트릭스 사이에 위치하는 생물학적 아교를 추가로 포함하는 붕대.
- 제6항에 있어서, 아교가 섬유소 밀봉재인 붕대.
- 제1항에 있어서, 커버가 제1 표면과 제2 표면을 포함하고, 제1 표면이 상처에 인접한 피부에 부착되기 위한 부착제를 포함하는 붕대.
- 제8항에 있어서, 커버가 진공 공급원과 상호교류하는 입구(port)를 추가로 포함하는 붕대.
- 제3항에 있어서, 구조물이 진공 공간을 한정하는 공기 통로를 커버와 SIS층 사이에 포함하는 다공질 패드인 붕대.
- 제10항에 있어서, 패드가 상처에 맞도록 절단되는 붕대.
- 제10항에 있어서, 패드가 가요성 물질을 포함하는 붕대.
- 제10항에 있어서, 패드 두께가 약 1 내지 2cm인 붕대.
- 제1항에 있어서, 구조물이 내벽에 의해 한정된 구멍을 갖는 환이며 진공 공간이 콜라겐 매트릭스, 커버, 및 환의 내벽에 의해 한정되는 붕대.
- 제1항에 있어서, 구조물이 콜라겐 매트릭스로부터 이격되어 있고 커버에 인접하도록 배치되어 있는 반경질 벽인 붕대.
- 제15항에 있어서, 반경질 벽이 환자의 상처 주위 피부에 인접하게 놓이는 저부 부재, SIS층으로부터 이격된 관계가 유지되도록 배치된 상부 부재, 및 상부 부재와 저부 부재에 완전히 결합된 중간 부재를 포함하고, 이때 중간 부재가 상부 부재를 SIS층과 이격된 관계로 지지하도록 제공되는 붕대.
- 제15항에 있어서, 반경질 벽이 돔(dome) 형태인 붕대.
- 제1항에 있어서, 커버를 진공 공급원에 연결시키기 위한 튜브를 추가로 포함하는 붕대.
- 상처 위에 놓이는 SIS층 및SIS층과 커버 내면 사이에 진공 공간을 제공하기 위해 상처와 SIS층 위에 놓이도록 배치되는 커버(이때, 진공 공간은 진공 공급원에 연결 가능하다)를 포함하는 상처 치유 붕대.
- 제19항에 있어서, 커버를 진공 공급원에 연결시키기 위한 진공 튜브를 추가로 포함하는 붕대.
- 상처 위에 놓이는 SIS층과, 상처 위에 진공 공간을 제공하기 위해 상처 위에 놓이는 커버를 포함하는 상처 치유 붕대를 제공하는 단계 및혈액을 상처로부터 상처 위에 놓인 SIS층으로 조절 가능하게 끌어당기기 위해 진공 공간내에 진공을 생성시키는 단계를 포함하는, 상처 치유 촉진방법.
- 제21항에 있어서, 유체를 상처로부터 SIS층으로 조절 가능하게 끌어당기기 위해 진공이 적용되는 기간과 적용되지 않는 기간이 교대로 제공되는 방법.
- 제21항에 있어서, 혈액을 상처로부터 SIS층으로 조절 가능하게 끌어당기기 위해 진공 공급원이 일정한 속도로 적용되는 방법.
- 제21항에 있어서, 생성 단계가 약 0.1 내지 약 0.15기압의 진공을 생성시키는 단계를 포함하는 방법.
- 제21항에 있어서, SIS층과 커버 사이의 진공 공간을 한정하기 위해 위치한 구조물을 추가로 포함하는 방법.
- SIS층을 상처 표면에 적용시키는 단계,지지체 구조물을 SIS층 위에 놓는 단계,진공 공간을 한정하기 위해 커버를 상처, SIS층 및 지지체 구조물 위에 놓는단계,커버를 진공 공급원에 연결시키는 단계 및진공 공간내에 진공을 생성시키는 단계를 포함하는, 상처 치유 촉진방법.
- 제1 콜라겐 매트릭스를 상처 표면에 적용시키는 단계,상처 및 제1 콜라겐 매트릭스와 상호교류하는 진공 공간을 생성시키는 단계 및혈액을 상처로부터 제1 콜라겐 매트릭스로 끌어당기기에 충분한 정도 및 기간 동안 진공 공간내에 진공을 생성시키는 단계를 포함하는, 상처 치유 촉진방법.
- 제27항에 있어서, 제1 콜라겐 매트릭스가 점막하조직 층을 포함하는 방법.
- 제28항에 있어서, 점막하조직 층이 SIS층인 방법.
- 제27항에 있어서, 생성 단계가 진공 공간을 제공하기 위해 제1 콜라겐 매트릭스와 커버 사이에 구조물을 위치시키는 단계를 포함하는 방법.
- 제30항에 있어서, 구조물이 진공 공간을 한정하는 공기 통로를 커버와 제1 콜라겐 매트릭스 사이에 포함하는 다공질 패드인 방법.
- 제30항에 있어서, 구조물이 내벽에 의해 한정된 구멍을 갖는 환이며 진공 공간이 제1 콜라겐 매트릭스, 커버, 및 환의 내벽에 의해 한정되는 방법.
- 제30항에 있어서, 구조물이 제1 콜라겐 매트릭스로부터 이격되어 있고 커버에 인접하도록 배치되어 있는 반경질 벽인 방법.
- 제27항에 있어서, 진공이 적용되는 기간과 적용되지 않는 기간이 교대로 제공되는 방법.
- 제27항에 있어서, 제1 콜라겐 매트릭스의 상처 표면으로의 통합을 개시하기에 충분한 기간 동안 진공이 생성되고, 제2 콜라겐 매트릭스를 제1 콜라겐 매트릭스 위치 위에 놓는 단계를 추가로 포함하는 방법.
- 상처 접촉용 점막하조직 층,다공질 패드 및진공 공급원과 상호교류하도록 배치되어 있는, 상처 주위 밀봉용 커버를 포함하는, 상처 치유 촉진용 키트(kit).
- 제36항에 있어서, 진공 튜브를 추가로 포함하는 키트.
- 제37항에 있어서, 점막하조직 층이 SIS인 키트.
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KR1020027015662A KR20030042441A (ko) | 2000-05-22 | 2001-05-15 | Sis와 진공 붕대의 복합체 및 상처 치유 방법 |
Country Status (15)
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US (8) | US7910791B2 (ko) |
EP (1) | EP1294325B1 (ko) |
JP (1) | JP2004509658A (ko) |
KR (1) | KR20030042441A (ko) |
AT (1) | ATE407647T1 (ko) |
AU (1) | AU2001261595A1 (ko) |
CA (1) | CA2409907A1 (ko) |
CZ (1) | CZ20023911A3 (ko) |
DE (1) | DE60135746D1 (ko) |
HU (1) | HUP0302301A2 (ko) |
MX (1) | MXPA02011416A (ko) |
NO (1) | NO20025608D0 (ko) |
PL (1) | PL203787B1 (ko) |
SK (1) | SK17982002A3 (ko) |
WO (1) | WO2001089431A1 (ko) |
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2001
- 2001-05-15 KR KR1020027015662A patent/KR20030042441A/ko not_active Application Discontinuation
- 2001-05-15 CA CA002409907A patent/CA2409907A1/en not_active Abandoned
- 2001-05-15 SK SK1798-2002A patent/SK17982002A3/sk unknown
- 2001-05-15 EP EP01935505A patent/EP1294325B1/en not_active Expired - Lifetime
- 2001-05-15 WO PCT/US2001/015611 patent/WO2001089431A1/en not_active Application Discontinuation
- 2001-05-15 AT AT01935505T patent/ATE407647T1/de not_active IP Right Cessation
- 2001-05-15 AU AU2001261595A patent/AU2001261595A1/en not_active Abandoned
- 2001-05-15 US US10/276,778 patent/US7910791B2/en not_active Expired - Fee Related
- 2001-05-15 MX MXPA02011416A patent/MXPA02011416A/es unknown
- 2001-05-15 JP JP2001585677A patent/JP2004509658A/ja active Pending
- 2001-05-15 DE DE60135746T patent/DE60135746D1/de not_active Expired - Lifetime
- 2001-05-15 US US09/855,287 patent/US20010043943A1/en not_active Abandoned
- 2001-05-15 CZ CZ20023911A patent/CZ20023911A3/cs unknown
- 2001-05-15 PL PL357417A patent/PL203787B1/pl not_active IP Right Cessation
- 2001-05-15 HU HU0302301A patent/HUP0302301A2/hu unknown
-
2002
- 2002-11-21 NO NO20025608A patent/NO20025608D0/no not_active Application Discontinuation
-
2005
- 2005-10-03 US US11/242,543 patent/US8747887B2/en active Active
-
2014
- 2014-05-07 US US14/272,291 patent/US9248052B2/en not_active Expired - Fee Related
-
2015
- 2015-12-30 US US14/984,932 patent/US9554945B2/en not_active Expired - Lifetime
-
2017
- 2017-01-04 US US15/398,419 patent/US9925091B2/en not_active Expired - Lifetime
-
2018
- 2018-02-08 US US15/892,211 patent/US10179072B2/en not_active Expired - Fee Related
- 2018-12-06 US US16/211,899 patent/US10966869B2/en not_active Expired - Lifetime
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US20060029650A1 (en) | 2006-02-09 |
HUP0302301A2 (hu) | 2003-10-28 |
SK17982002A3 (sk) | 2003-04-01 |
NO20025608L (no) | 2002-11-21 |
US9554945B2 (en) | 2017-01-31 |
US7910791B2 (en) | 2011-03-22 |
US9925091B2 (en) | 2018-03-27 |
PL357417A1 (en) | 2004-07-26 |
EP1294325A1 (en) | 2003-03-26 |
US20190105201A1 (en) | 2019-04-11 |
CA2409907A1 (en) | 2001-11-29 |
NO20025608D0 (no) | 2002-11-21 |
ATE407647T1 (de) | 2008-09-15 |
DE60135746D1 (de) | 2008-10-23 |
MXPA02011416A (es) | 2004-08-12 |
CZ20023911A3 (cs) | 2003-03-12 |
EP1294325B1 (en) | 2008-09-10 |
US10179072B2 (en) | 2019-01-15 |
US20160106594A1 (en) | 2016-04-21 |
US20180161210A1 (en) | 2018-06-14 |
WO2001089431A1 (en) | 2001-11-29 |
AU2001261595A1 (en) | 2001-12-03 |
US9248052B2 (en) | 2016-02-02 |
US10966869B2 (en) | 2021-04-06 |
US20140330226A1 (en) | 2014-11-06 |
PL203787B1 (pl) | 2009-11-30 |
US8747887B2 (en) | 2014-06-10 |
EP1294325A4 (en) | 2006-10-11 |
JP2004509658A (ja) | 2004-04-02 |
US20010043943A1 (en) | 2001-11-22 |
US20030208149A1 (en) | 2003-11-06 |
US20170112672A1 (en) | 2017-04-27 |
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