JP4473861B2 - 弁 - Google Patents
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- JP4473861B2 JP4473861B2 JP2006506000A JP2006506000A JP4473861B2 JP 4473861 B2 JP4473861 B2 JP 4473861B2 JP 2006506000 A JP2006506000 A JP 2006506000A JP 2006506000 A JP2006506000 A JP 2006506000A JP 4473861 B2 JP4473861 B2 JP 4473861B2
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- 210000001765 aortic valve Anatomy 0.000 abstract description 3
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Classifications
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2415—Manufacturing methods
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Manufacturing & Machinery (AREA)
- Prostheses (AREA)
- Magnetically Actuated Valves (AREA)
- Electrically Driven Valve-Operating Means (AREA)
- Temperature-Responsive Valves (AREA)
Description
この枠は、使用時に血流に対してほぼ垂直に配向される環状部を備えており、この枠は第1端部と第2端部を有しており、一方の端部が、少なくとも2つの柱により分離され定められる少なくとも2つの波形縁部を定め、各小葉が波形縁部に沿って枠に取り付けられており、開位置と閉位置との間で動くことができる。
また、少なくとも2つの小葉のそれぞれは、血液流入側、血液流出側、および少なくとも1つの自由縁を有している。第1小葉の少なくとも1つの自由縁が、第2小葉またはさらに別の小葉の少なくとも1つの自由縁に向かって動かされるような形態で、少なくとも2つの小葉は、流体圧力が流出側にかかっているときに、閉位置とされる。また、第1小葉の少なくとも1つの自由縁が、第2小葉またはさらに別の小葉の少なくとも1つの自由縁から離れる方向に動かされるような形態で、少なくとも2つの小葉は、流体圧力が血液流入側にかかっているときに、開位置とされる。
更に、血流の軸線に垂直な第1平面において、柱の縦軸(Z)に沿った任意の位置における柱間の円周方向(XY)における各小葉の長さは、放物線関数により定義される。
により定義することが好ましい。
ここで、YZは、所定の座標XおよびZにおけるYオフセットであり、
Rは、放物線最大値であり、
LZは、高さZにおける枠の第1柱と第2柱との間の直線距離であり、
xは、柱の基点から別の柱までの距離である。
また、放物線の長さは次の式により決めることができる。
ここで、YZは、所定の座標XおよびZにおけるYオフセットであり、
Rは、放物線最大値であり、
LZは、高さZにおける枠の第1柱と第2柱との間の直線距離であり、
xは、柱の基点から別の柱までの距離である。
また、放物線の長さは次の式により決めることができる。
− 小葉形成面の円周方向(XY)における長さが放物線関数により定義されるような、少なくとも2つの小葉形成面を有する形成要素を提供するステップ、
− この形成要素を枠に係合させるステップ、
− この枠および係合された形成要素に被覆を施すステップであって、該被覆は枠に結合し、小葉形成面を覆う該被覆は少なくとも2つの可撓性のある小葉を形成し、少なくとも2つの可撓性のある小葉は、放物線関数により定義される円周方向(XY)における長さと、第1小葉が中立位置にあるときに、第1小葉と、血流軸に垂直な少なくとも1つの平面との交差により波が形成されるような表面輪郭とを有する、前記被覆を施すステップ、
− 形成要素から枠を外すステップ。
− 形成要素を成形用溶液に浸すステップ、
− 成形用溶液に浸された前記形成要素を反転させるステップ、
− このようにして形成要素上に形成された被覆を乾燥または硬化できるように、形成要素を成形用溶液から分離するステップ。
(i)形成要素を台に取り付けるステップ、
(ii)ハウジングを前記台に密封して、密室を形成するステップ、
(iii)形成要素が浸されるまで、前記密室に成形用溶液を充填するステップ、
(iv)前記密室を反転させるステップ、
(v)被覆された形成要素を成形用溶液から分離するステップ。
− 少なくとも1つの形成要素を保持するのに適した少なくとも1つの台と、
− 前記少なくとも1つの形成要素を収めるのに適した開口端を有する少なくとも1つのハウジングと、
− 成形用溶液を保持するのに適した密室を形成するために、前記ハウジングを前記台に可逆的に密封する密封手段と、
− 前記密室を反転させる手段と、
− 成形用溶液を密室に注入するための、閉鎖可能な注入手段と、
− 成形用溶液をハウジングから排出するための、閉鎖可能な排出手段と
を備えている。
(ii)細長い刃と、
(iii)動作時に振動子により、刃が刃の縦軸に沿った方向で振動できるように、刃を振動子に取り外し自在に取り付けることを可能にする取り付け手段と
を備える超音波切断装置を用いて小葉を切断してもよい。
(i)アームに回転可能な玉軸受を有する、切断される成形品の表面において切断装置の刃を案内する針と、
(ii)針を超音波切断装置に取り付けるための取り付け手段と
をさらに備えることが好ましい。
(i)切断される心臓弁小葉に対して刃を位置決めするステップ、
(ii)刃を振動させるステップ、
(iii)刃が心臓弁小葉を所要の形状に切断するように、切断される心臓弁小葉を振動刃に対して動かすか、あるいは切断される心臓弁小葉に対して振動刃を動かすステップ。
a)枠と少なくとも2つの可撓性のある小葉を備える心臓弁のモデルを提供するステップ、
b)使用中に少なくとも1つの心臓弁小葉が受ける負荷を生成し、これらの負荷をモデルにかけるステップ、
c)小葉の応力分布を決めるステップ、
d)Zの任意の位置に対してXYにおける小葉の円周長さを変更するステップ、
e)小葉の新たな応力分布を決めるステップ、
f)小葉における局部応力集中を最小限に抑えるためにステップdおよびステップeを繰り返すステップ。
z2+y2=2RL(x−g)−α(x−g)2
ここで、Zは血流軸における小葉の形状を定義し、ZはZ2として定義されるため、上記の式により定義される小葉の幾何形状は血流に平行な軸において球状となる。国際公開第98/32400号パンフレットにおいて、小葉の縁の表面が球状であれば、平面状または円錐状である場合よりも効果的な密封が実現されることが開示されている。国際公開第01/411679号パンフレットにおいて、負荷がステントに伝えられる交連の領域において応力が最も高いが、閉じた弁において小葉の腹状の膨らみが実用上可能な限り少なければ応力が低減することが開示されている。
ここで、YZは、所定の座標XおよびZにおけるYオフセットであり、
Rは、放物線最大値であり、
LZは、高さZにおける枠の第1柱と第2柱との間の直線距離であり、
Xは、柱の基点から別の柱までの距離である。
Claims (15)
- 枠と少なくとも2つの可撓性のある小葉とを備える人工心臓弁であって、
前記枠は、使用時に血流に対してほぼ垂直に配向される環状部を備えており、前記枠は第1端部と第2端部とを有しており、前記端部の一方は少なくとも2つの柱により分離され定められる少なくとも2つの波形縁部を定め、前記各小葉は前記波形縁部に沿って前記枠に取り付けられており開位置と閉位置との間で動くことができるようになっており、
前記少なくとも2つの小葉のそれぞれは、血液流入側、血液流出側、および少なくとも1つの自由縁を有しており、第1小葉の前記少なくとも1つの自由縁が、第2小葉またはさらに別の小葉の前記少なくとも1つの自由縁に向かって動かされるような形態で、前記少なくとも2つの小葉は、流体圧力が流出側にかかっているときに、閉位置とされ、第1小葉の前記少なくとも1つの自由縁が、第2小葉またはさらに別の小葉の前記少なくとも1つの自由縁から離れる方向に動かされるような形態で、前記少なくとも2つの小葉は、流体圧力が血液流入側にかかっているときに、開位置とされ、
血流の軸に垂直な第1平面において、前記柱の縦軸(Z)に沿った任意の位置における前記柱間の円周方向(XY)における前記各小葉の形状およびその長さが放物線関数により定義され、前記弁が閉位置にあるときに前記放物線関数により決定される前記長さが前記高さ(Z)に対してほぼ線形に変化する、人工心臓弁。 - 前記柱の前記縦軸(Z)に沿った任意の位置における前記柱間の前記円周方向(XY)における前記小葉の長さを定義する前記放物線関数は、
(YZは、所定の座標XおよびZにおけるYオフセットであり、
Rは、放物線最大値であり、
LZは、高さZにおける前記枠の第1柱と第2柱との間の直線距離であり、
xは、柱の基点から別の柱までの距離である)
上記の式により定義される前記放物線の前記長さが
- 3つの小葉を備える、請求項1または2に記載の人工心臓弁。
- 前記枠は折り畳み可能なステントである、請求項1〜3のいずれか1項に記載の人工心臓弁。
- 少なくとも1つの前記小葉は、前記小葉の前記自由縁の長さが前記XY方向における前記小葉の前記長さよりも長くなるように構成されている、請求項1〜4のいずれか1項に記載の人工心臓弁。
- 前記小葉の前記自由縁は、前記XY方向に垂直な縦方向(Z)において前記小葉の前記自由縁が放物線状であるように構成されている、請求項5に記載の人工心臓弁。
- 心臓弁において使用するための弁小葉であって、
前記弁は、枠と、開位置および閉位置の間で動くことができる可撓性のある少なくとも2つの小葉とを備え、
前記枠は、使用時に血流に対してほぼ垂直に配向される環状部を備えており、前記枠は第1端部と第2端部とを有しており、前記端部の一方は少なくとも2つの柱により分離され定められる少なくとも2つの波形縁部を定め、
前記小葉は、前記枠の対応する柱の波形縁部にそれぞれ取り付け可能な第1外側縁と第2外側縁を有しており、
前記血流に対してほぼ垂直な(XY)平面において、前記外側縁に沿って任意の高さ(Z)において測定される前記外側縁間の前記小葉の形状およびその長さは放物線関数により定義され、
前記閉位置において、前記放物線関数により決定される前記長さが前記高さ(Z)に対してほぼ線形に変化する、弁小葉。 - 前記弁小葉において、
前記放物線関数は
(YZは、所定の座標XおよびZにおけるYオフセットであり、
Rは、放物線最大値であり、
LZは、高さZにおける、対応する柱に取り付けるための第1外側縁と第2の対応する柱に取り付けるための第2外側縁との間の直線距離であり、
xは、前記第1の対応する柱の基点から前記第2の対応する柱までの距離である)
上記の式により定義される前記放物線の前記長さが
- 人工心臓弁を製造する方法であって、
(a)小葉形成面の円周方向(XY)における形状およびその長さが放物線関数により定義されるような少なくとも2つの小葉形成面であって、前記弁が閉位置にあるときに前記放物線関数により決定される前記長さが前記高さ(Z)に対してほぼ線形に変化する少なくとも2つの小葉形成面を有する形成要素を提供するステップと、
(b)前記形成要素を枠に係合させるステップと、
(c)前記枠および係合された前記形成要素に被覆を施すステップであり、該被覆は前記枠に結合するものであり、小葉形成面を覆う該被覆は少なくとも2つの可撓性のある小葉を形成するものであり、当該小葉の形状およびその長さは、前記血流に対してほぼ垂直な(XY)平面において前記外側縁に沿って任意の高さ(Z)において測定される前記外側縁間の前記小葉の形状およびその長さが放物線関数により定義され、前記弁が閉位置にあるときに前記放物線関数により決定される前記長さが前記高さ(Z)に対してほぼ線形に変化するものであり、前記小葉の表面輪郭は、使用中に前記第1小葉が中立位置にあるときに、前記第1小葉と、血流軸に垂直な少なくとも1つの平面との交差により波が形成されるようなものである、前記被覆を施すステップと、
(d)前記形成要素から前記枠を外すステップと、
を含む方法。 - 前記弁は請求項1〜6のいずれか1項に記載の弁である、請求項9に記載の方法。
- 前記形成要素は3つの小葉形成面を有している、請求項9または10に記載の方法。
- 前記小葉の自由縁を形成するステップをさらに含む、請求項9〜11のいずれか1項に記載の方法。
- 前記小葉の前記自由縁がXY方向に垂直な縦方向(Z)において放物線状に形成される、請求項12に記載の方法。
- 請求項1〜6のいずれか1項に記載の人工心臓弁を設計する方法であって、
a)枠と少なくとも2つの可撓性のある小葉を備える心臓弁のモデルを提供するステップと、
b)使用中に少なくとも1つの心臓弁小葉が受ける負荷を生成し、これらの負荷を前記モデルにかけるステップと、
c)前記小葉の応力分布を決めるステップと、
d)Zにおける任意の位置についてXYにおける前記小葉の円周長さを変更するステップと、
e)前記小葉の新たな応力分布を決めるステップと、
f)前記小葉における局部応力集中を最小限に抑えるためにステップdおよびステップeを繰り返すステップと、
を含む、方法。 - 前記心臓弁が開位置と閉位置との間を繰返し運動する際に前記小葉の前記応力分布に影響する要因を考慮するように前記モデルを調整するステップをさらに含む、請求項14に記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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GB0306472A GB0306472D0 (en) | 2003-03-20 | 2003-03-20 | Valve |
GB0319321A GB0319321D0 (en) | 2003-08-16 | 2003-08-16 | Valve |
PCT/GB2004/001244 WO2004082536A1 (en) | 2003-03-20 | 2004-03-22 | Valve |
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JP2006520633A JP2006520633A (ja) | 2006-09-14 |
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GB2407146B (en) | 2006-04-26 |
JP2006520633A (ja) | 2006-09-14 |
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