JP6010530B2 - 経カテーテル人工僧帽弁 - Google Patents
経カテーテル人工僧帽弁 Download PDFInfo
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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
- 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
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- 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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
-
- 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
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
-
- 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
-
- 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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
-
- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
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- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
-
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
-
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
- A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0034—D-shaped
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- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/005—Rosette-shaped, e.g. star-shaped
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- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0054—V-shaped
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
Description
本発明は、概して、医療デバイスおよび方法に関し、より具体的には、僧帽弁逆流とも呼ばれる、僧帽弁閉鎖不全症等の弁不全症の治療に関する。従来の外科的埋込方法によって、または低侵襲経皮カテーテルあるいは低侵襲経心尖的方法によって送達される、人工弁の使用が、弁不全症に対する1つの可能な治療である。
(項目1)
患者の心臓の中に人工弁を固着する方法であって、
該方法は、
該人工弁を提供することであって、該人工弁は、アンカーを備え、該アンカーは、心房スカート、環状領域、心室スカート、および複数の弁尖を有し、該アンカーは、該心臓に送達するための折畳み構成、および該心臓と固着するための拡張構成を有する、ことと、
該患者の心臓の中に該人工弁を設置することと、
該患者の自然僧帽弁の上面の上に横たわるように、半径方向外向きに該心房スカートを拡張し、該心房の一部分に対して該心房スカートを固着することと、
自然僧帽弁輪と一致するように、およびそれに係合するように、該アンカーの該環状領域を半径方向に拡張させることと、
該心室スカートを半径方向に拡張し、それにより、自然僧帽弁尖を半径方向外向きに変位させることと
を含む、方法。
(項目2)
前記人工弁の少なくとも一部分は、組織または合成材料によって覆われている、項目1に記載の方法。
(項目3)
前記人工弁を設置することは、前記心臓の右心房から左心房まで該人工弁を経中隔的に送達することを含む、項目1に記載の方法。
(項目4)
前記人工弁を設置することは、前記心臓の外側の領域から該心臓の前記左心室まで該人工弁を経心尖的に送達することを含む、項目1に記載の方法。
(項目5)
前記心房スカートを拡張させることは、該心房スカートから離れるように制約シースを摺動可能に移動させ、それにより、該心房スカートの半径方向拡張を可能にすることを含む、項目1に記載の方法。
(項目6)
前記心房スカートは、前記制約シースが該心房シースから除去されたときに自己拡張する、項目5に記載の方法。
(項目7)
前記人工弁に力を印加することをさらに含み、該力を印加することにより、前記心房スカートが前記僧帽弁の前記上面に係合することを確実にする、項目1に記載の方法。
(項目8)
前記心房スカートは、複数の鉤を備え、該心房スカートを拡張することは、前記僧帽弁の前記上面の中に該鉤を固着することを含む、項目1に記載の方法。
(項目9)
前記心房スカートを拡張することは、前記自然僧帽弁の前記上面に対して該心房スカートを密閉することを含む、項目1に記載の方法。
(項目10)
前記環状領域を半径方向に拡張することは、該環状領域から離れるように制約シースを摺動可能に移動させ、それにより、該環状領域の半径方向拡張を可能にすることを含む、項目1に記載の方法。
(項目11)
前記環状領域は、前記制約シースが該環状領域から除去されたときに自己拡張する、項目10に記載の方法。
(項目12)
前記環状領域を半径方向に拡張することは、該環状領域を非対称的に拡張することを含み、該非対称に拡張することにより、該環状領域の前方部分は実質的に平坦であり、該環状領域の後方部分は円筒形状である、項目1に記載の方法。
(項目13)
前記心室スカートは、該心室スカートの前方部分上に三角固着タブをさらに備え、該心室スカートを半径方向に拡張することは、前記自然僧帽弁の前尖の第1の側面上の第1の線維性三角に対して該三角固着タブを固着することを含み、該三角固着タブを固着することにより、該自然前尖および隣接腱索が、該三角固着タブと前記アンカーの前面との間に捕捉される、項目1に記載の方法。
(項目14)
前記心室スカートは、該心室スカートの前記前方部分上に第2の三角固着タブをさらに備え、該心室スカートを半径方向に拡張することは、前記第1の線維性三角の反対側の第2の線維性三角に対して該第2の三角固着タブを固着することを含み、該第2の三角固着タブを固着することにより、前記自然前尖および隣接腱索が、該第2の三角固着タブと前記アンカーの前面との間に捕捉される、項目13に記載の方法。
(項目15)
前記心室スカートは、該心室スカートの後方部分上に後方心室固着タブをさらに備え、該心室スカートを半径方向に拡張することは、前記自然僧帽弁の後尖を覆って該後方心室固着タブを固着することを含み、該後方心室固着タブを固着することにより、該心室スカートは、該後尖と前記心臓の心室壁との間に着座する、項目1に記載の方法。
(項目16)
前記心室スカートを半径方向に拡張することは、該心室スカートから離れるように制約シースを摺動可能に移動させ、それにより、該心室スカートの半径方向拡張を可能にすることを含む、項目1に記載の方法。
(項目17)
前記心室スカートは、前記制約シースが該心室スカートから除去されたときに自己拡張する、項目16に記載の方法。
(項目18)
前記心室スカートは、複数の鉤を備え、該心室スカートを拡張することは、心臓組織の中に該鉤を固着することを含む、項目1に記載の方法。
(項目19)
前記人工弁は、複数の人工弁尖を備え、前記心室スカートを半径方向に拡張することは、前記自然僧帽弁尖を半径方向外向きに変位させ、それにより、該人工弁尖への該自然僧帽弁尖の干渉を防止することを含む、項目1に記載の方法。
(項目20)
前記心室スカートを半径方向に拡張することは、心室壁に接触することなく、および左心室流出路を塞ぐことなく、前記自然僧帽弁尖を半径方向外向きに変位させることを含む、項目1に記載の方法。
(項目21)
前記心室スカートを半径方向に拡張することは、該心室スカートを非対称的に拡張することを含み、該非対称に拡張することにより、該心室スカートの前方部分は実質的に平坦であり、該心室スカートの後方部分は円筒形状である、項目1に記載の方法。
(項目22)
前記心房スカートは、整列要素を備え、前記方法は、前記患者の弁に対して該整列要素を整列させることをさらに含む、項目1に記載の方法。
(項目23)
前記弁は、僧帽弁を備え、前記整列させることは、前記整列要素を大動脈起始部と整列させ、該僧帽弁の前尖の2つの線維性三角の間に該整列要素を配置することを含む、項目22に記載の方法。
(項目24)
前記整列させることは、前記人工弁を回転させることを含む、項目22に記載の方法。
(項目25)
前記人工弁は、交連に連結される複数の人工弁尖を備え、前記方法は、送達カテーテルから該交連を解放することを含む、項目1に記載の方法。
(項目26)
前記人工弁は、三尖弁尖構成を備える、項目25に記載の方法。
(項目27)
前記人工弁は、開放構成および閉鎖構成を有し、該開放構成において、前記人工弁尖が相互から離れて配置され、該閉鎖構成において、該人工弁尖が相互に係合し、血液は、該開放構成における該人工弁を通って自由に流れ、該人工弁を横断する逆行血流は、該閉鎖構成において実質的に妨げられる、項目1に記載の方法。
(項目28)
僧帽弁逆流を低減または排除することをさらに含む、項目1に記載の方法。
(項目29)
前記人工弁は、治療薬を備え、前記方法は、該人工弁から隣接組織の中に該治療薬を溶出することをさらに含む、項目1に記載の方法。
(項目30)
人工心臓弁であって、
該人工心臓弁は、
心房スカート、環状領域、および心室スカートを有するアンカーであって、該アンカーは、心臓に送達するための折畳み構成、および該人工心臓弁を患者の心臓に固着するための拡張構成を有する、アンカーと、
複数の人工弁尖であって、該弁尖の各々は、第1端および自由端を有し、該第1端は、該アンカーと連結され、該自由端は、該第1端の反対側にある、人工弁尖と
を備え、
該人工心臓弁は、開放構成および閉鎖構成を有し、該開放構成において、該人工弁尖の該自由端が相互から離れて配置されることにより、順行血流がそれを通り越すことを可能にし、該閉鎖構成において、該人工弁尖の該自由端が相互に係合して、逆行血流がそれを通り越すことを実質的に防止する、人工心臓弁。
(項目31)
前記心房スカートの少なくとも一部分は、組織または合成材料によって覆われている、項目30に記載の人工心臓弁。
(項目32)
前記心房スカートは、それに連結される複数の鉤を備え、該複数の鉤は、前記患者の僧帽弁の上面の中に該心房スカートを固着するようにさらに適合される、項目30に記載の人工心臓弁。
(項目33)
前記心房スカートは、折畳み構成および拡張構成を有し、該折畳み構成は、前記患者の心臓に送達するために適合され、該拡張構成は、該折畳み構成に対して半径方向に拡張されており、該患者の自然僧帽弁の上面の上に横たわるように適合されており、それにより、心房の一部分に対して該心房スカートを固着する、項目30に記載の人工心臓弁。
(項目34)
前記心房スカートは、拘束されていないときに、前記折畳み構成から前記半径方向拡張構成まで自己拡張する、項目33に記載の人工心臓弁。
(項目35)
前記心房スカートは、1つ以上の放射線不透過性マーカーを備える、項目30に記載の人工心臓弁。
(項目36)
前記心房スカートは、複数の軸方向に配向された支柱を備え、該複数の支柱は、コネクタ要素によって一緒に接続され、該複数の相互接続された支柱は、一連の頂点および谷間を形成する、項目30に記載の人工心臓弁。
(項目37)
前記環状領域の少なくとも一部分は、組織または合成材料によって覆われている、項目30に記載の人工心臓弁。
(項目38)
前記環状領域は、折畳み構成および拡張構成を有し、該折畳み構成は、前記患者の心臓に送達するために適合され、該拡張構成は、該折畳み構成に対して半径方向に拡張されており、自然僧帽弁環に順応し、それに係合するように適合される、項目30に記載の人工心臓弁。
(項目39)
前記環状領域は、拘束されていないときに、前記折畳み構成から前記拡張構成まで自己拡張する、項目38に記載の人工心臓弁。
(項目40)
前記環状領域は、非対称的なD字形の断面を備え、該非対称的なD字形の断面は、実質的に平坦な前方部分と、円筒形状の後方部分とを有する、項目30に記載の人工心臓弁。
(項目41)
前記環状領域は、複数の軸方向に配向された支柱を備え、該複数の支柱は、コネクタ要素によって一緒に接続され、該複数の相互接続された支柱は、一連の頂点および谷間を形成する、項目30に記載の人工心臓弁。
(項目42)
前記軸方向に配向された支柱のうちの1つ以上は、それを通って延在する1つ以上の縫合糸穴を備え、該縫合糸穴は、縫合糸を受容するようにサイズ決定される、項目41に記載の人工心臓弁。
(項目43)
前記心室スカートの少なくとも一部分は、組織または合成材料によって覆われている、項目30に記載の人工心臓弁。
(項目44)
前記心室スカートは、非対称的なD字形の断面を備え、該断面は、実質的に平坦な前方部分と、円筒形状の後方部分とを有する、項目30に記載の人工心臓弁。
(項目45)
前記心室スカートは、折畳み構成および拡張構成を有し、該折畳み構成は、前記患者の心臓に送達するために適合され、該拡張構成は、該折畳み構成に対して半径方向に拡張されており、自然僧帽弁尖を半径方向外向きに変位させるように適合される、項目30に記載の人工心臓弁。
(項目46)
前記心室スカートは、拘束されていないときに、前記折畳み構成から前記拡張構成まで自己拡張する、項目45に記載の人工心臓弁。
(項目47)
前記心室スカートは、該心室スカートの前方部分上に配置された三角固着タブをさらに備え、該三角固着タブは、前記患者の僧帽弁の前尖の第1の側面上の第1の線維性三角に対して固着されるように適合され、それにより、該前尖および隣接腱索が、該三角固着タブと前記アンカーの前面との間に捕捉される、項目30に記載の人工心臓弁。
(項目48)
前記心室スカートは、該心室スカートの前記前方部分上に配置される第2の三角固着タブをさらに備え、該第2の三角固着タブは、前記第1の線維性三角の反対側の第2の線維性三角に対して固着されるように適合されることにより、前記前尖および隣接腱索が、該第2の三角固着タブと前記アンカーの前面との間に捕捉される、項目47に記載の人工心臓弁。
(項目49)
前記心室スカートは、該心室スカートの後方部分上に配置される後方心室固着タブをさらに備え、該後方心室固着タブは、前記患者の僧帽弁の後尖を覆って固着されるように適合され、それにより、該後方心室固着タブは、該後尖と該患者の心臓の心室壁との間に着座させられる、項目30に記載の人工心臓弁。
(項目50)
前記心室スカートは、それに連結される複数の鉤をさらに備え、該複数の鉤は、心臓組織の中に該心室スカートを固着するように適合される、項目30に記載の人工心臓弁。
(項目51)
前記心室スカートは、複数の支柱を備え、該複数の支柱は、コネクタ要素によって一緒に接続され、該複数の相互接続された支柱は、一連の頂点および谷間を形成する、項目30に記載の人工心臓弁。
(項目52)
前記支柱のうちの1つ以上は、それを通って延在する1つ以上の縫合糸穴を備え、該縫合糸穴は、縫合糸を受容するようにサイズ決定される、項目51に記載の人工心臓弁。
(項目53)
前記複数の人工弁尖は、三尖弁尖構成を備える、項目30に記載の人工心臓弁。
(項目54)
1つ以上の人工弁尖の少なくとも一部分は、組織または合成材料を備える、項目30に記載の人工心臓弁。
(項目55)
前記複数の人工弁尖のうちの1つ以上は、1つ以上の支柱に連結され、該1つ以上の支柱は、前記心室スカートに対して半径方向内向きに付勢される、項目30に記載の人工心臓弁。
(項目56)
前記1つ以上の支柱は、それを通って延在する1つ以上の縫合糸穴を備え、該縫合糸穴は、縫合糸を受容するようにサイズ決定される、項目55に記載の人工心臓弁。
(項目57)
前記人工弁尖のうちの1つ以上は、交連柱に連結され、該交連柱は、該交連柱を送達デバイスと解放可能に係合させるように適合される交連タブを有する、項目30に記載の人工心臓弁。
(項目58)
前記アンカーの前方部分に連結される整列要素をさらに備え、該整列要素は、前記患者の心臓の大動脈起始部と整列させられ、該患者の僧帽弁の前尖の2つの線維性三角の間に配置されるように適合される、項目30に記載の人工心臓弁。
(項目59)
前記整列要素は、前記心房スカートと連結される、項目58に記載の人工心臓弁。
(項目60)
前記人工心臓弁は、それに連結される治療薬をさらに備え、該治療薬は、そこから溶出されるように適合される、項目30に記載の人工心臓弁。
(項目61)
人工心臓弁を患者の心臓に送達するための送達システムであって、
該システムは、
管腔が自身を通って延在している内側ガイドワイヤシャフトであって、該管腔は、ガイドワイヤを摺動可能に受容するように適合されている、内側ガイドワイヤシャフトと、
該内側ガイドワイヤシャフトを覆って同心円状に配置されるハブシャフトと、
該ハブシャフトを覆って摺動可能および同心円状に配置されるベルシャフトと、
該ベルシャフト覆って摺動可能および同心円状に配置されるシースと、
該送達システムの近位端付近のハンドルであって、該ハンドルは、アクチュエータ機構を備え、該アクチュエータ機構は、該ベルシャフトおよび該シースを前進および後退させるように適合される、ハンドルと
を備える、システム。
(項目62)
前記人工心臓弁をさらに備え、該人工心臓弁は、半径方向の折畳み構成で前記シースの中に収納される、項目61に記載のシステム。
(項目63)
前記人工心臓弁は、
心房スカート、環状領域、および心室スカートを有するアンカーと、
複数の人工弁尖であって、該弁尖の各々は、第1端および自由端を有し、該第1端は、該アンカーと連結され、該自由端は、該第1端の反対側にあり、該人工心臓弁は、開放構成および閉鎖構成を有し、該開放構成において、該人工弁尖の該自由端が相互から離れて配置されることにより、順行血流がそれを通り越すことを可能にし、該閉鎖構成において、該人工弁尖の該自由端が相互に係合して、逆行血流がそれを通り越すことを実質的に防止する、人工弁尖と
を備える、項目62に記載のシステム。
(項目64)
前記ベルシャフトに対する前記シースの近位への後退は、前記人工心臓弁から拘束を除去し、それにより、該人工心臓弁が自己拡張して前記患者の自然心臓組織と係合することを可能にする、項目62に記載のシステム。
(項目65)
前記人工心臓弁は、前記ハブシャフトと解放可能に連結され、該ハブシャフトに対する前記ベルシャフトの近位への後退は、該ハブシャフトから該人工心臓弁を解放する、項目62に記載のシステム。
(項目66)
前記アクチュエータ機構は、回転ホイールを備える、項目61に記載のシステム。
(項目67)
前記ハブシャフトに連結される組織貫通遠位先端をさらに備え、該組織貫通遠位先端は、前記患者の心臓を通過し、該患者の心臓の切開を拡張するように適合される、項目61に記載のシステム。
(項目68)
ピンロック機構をさらに備え、該ピンロック機構は、前記ハンドルと解放可能に連結され、該ピンロック機構は、前記シースの近位への後退を制限する、項目61に記載のシステム。
本発明は、概して、医療デバイスおよび方法に関し、より具体的には、僧帽弁逆流を治療するために使用される人工弁に関する。本開示は、僧帽弁逆流を治療するための人工弁の使用に焦点を当てているが、これは、限定的となることを目的としない。本明細書で開示される人工弁は、また、他の心臓弁または静脈弁を含む他の身体弁を治療するために使用されてもよい。例示的な心臓弁は、大動脈弁、三尖弁、または肺動脈弁を含む。
例えば、心房スカート領域806は、一連の頂点および谷間を形成する複数の相互接続した支柱を含む。人工弁の平坦な前方領域802は、心房スカートの残りの部分の頂点および谷間から軸方向にオフセットした、その頂点および谷間を有し、この領域は、整列要素814の一部になる。放射線不透過性マーカー814aは、オフセットした頂点および谷間の両側に配置され、弁の埋込中の可視化に役立つ。軸方向に配向したコネクタは、スカート領域806の支柱を環状領域808の支柱と接合する。環状領域はまた、頂点および谷間を形成する、複数の軸方向に配向および相互接続した支柱から成る。コネクタ支柱は、環状領域の支柱を心室領域810の支柱と連結する。心室領域はまた、頂点および谷間を形成する、複数の相互接続した支柱も含む。加えて、支柱は、弁尖交連813、心室スカート828、ならびに三角および後方タブ824、830を形成する。縫合糸穴821は、心膜あるいはDacronまたはePTFE等のポリマー等のカバーの付着を可能にするように、環状領域の支柱ならびに心室領域に沿って配置される。鉤823は、人工弁を隣接組織に固着することに役立つように、心室スカート828に沿って配置される。交連タブまたはタブ812は、交連813の先端上に配置され、以下で説明されるように、人工弁を送達システムと解放可能に連結するために使用されてもよい。当業者であれば、いくつかの支柱幾何学形状が使用されてもよく、加えて、剛性、半径方向粉砕強度、交連偏向等の所望の機械的性質をアンカーに提供するために、長さ、幅、厚さ等の支柱寸法が調整されてもよいことを理解するであろう。したがって、図示した幾何学形状は、限定的となることを目的としない。
Claims (15)
- 人工心臓弁であって、
該人工心臓弁は、
心房スカート、環状領域、および心室スカートを有するアンカーであって、該アンカーは、心臓に送達するための折畳み構成、および該人工心臓弁を患者の心臓に固着するための拡張構成を有し、該心房スカートは、非対称的なD字形の断面を備え、該非対称的なD字形の断面は、円筒形状の後方部分と、左心室流出路の衝突または閉塞を防止するように構成される実質的に平坦な前方部分とを有し、該心室スカートは、該心室スカートの前方部分上に配置された三角固着タブを備え、該三角固着タブは、該アンカーから半径方向外向きに延在し、該患者の心臓の心房に面し、該三角固着タブは、該患者の僧帽弁の前尖の第1の側面上の第1の線維性三角に対して固着されるように適合され、それにより、該前尖および隣接腱索が、該三角固着タブと該アンカーの前面との間に捕捉される、アンカーと、
複数の人工弁尖であって、該弁尖の各々は、第1端および自由端を有し、該第1端は、該アンカーと連結され、該自由端は、該第1端の反対側にある、人工弁尖と
を備え、
該人工心臓弁は、開放構成および閉鎖構成を有し、該開放構成において、該人工弁尖の該自由端が相互から離れて配置されることにより、順行血流がそれを通り越すことを可能にし、該閉鎖構成において、該人工弁尖の該自由端が相互に係合して、逆行血流がそれを通り越すことを実質的に防止する、人工心臓弁。 - 前記心房スカート、前記環状領域、または前記心室スカートの少なくとも一部分は、組織または合成材料によって覆われている、請求項1に記載の人工心臓弁。
- 前記心房スカートは、拘束されていないときに、前記折畳み構成から前記半径方向拡張構成まで自己拡張する、請求項1に記載の人工心臓弁。
- 前記環状領域は、拘束されていないときに、前記折畳み構成から前記拡張構成まで自己拡張する、請求項1に記載の人工心臓弁。
- 前記環状領域は、非対称的なD字形の断面を備え、該非対称的なD字形の断面は、円筒形状の後方部分と、左心室流出路の衝突または閉塞を防止するように構成される実質的に平坦な前方部分とを有する、請求項1に記載の人工心臓弁。
- 前記心室スカートは、非対称的なD字形の断面を備え、該非対称的なD字形の断面は、円筒形状の後方部分と、左心室流出路の衝突または閉塞を防止するように構成される実質的に平坦な前方部分とを有する、請求項1に記載の人工心臓弁。
- 前記心室スカートは、拘束されていないときに、前記折畳み構成から前記拡張構成まで自己拡張する、請求項1に記載の人工心臓弁。
- 前記心室スカートは、該心室スカートの前記前方部分上に配置される第2の三角固着タブをさらに備え、該第2の三角固着タブは、前記第1の線維性三角の反対側の第2の線維性三角に対して固着されるように適合され、それにより、前記前尖および隣接腱索が、該第2の三角固着タブと前記アンカーの前面との間に捕捉される、請求項1に記載の人工心臓弁。
- 前記心室スカートは、該心室スカートの後方部分上に配置される後方心室固着タブをさらに備え、該後方心室固着タブは、前記患者の僧帽弁の後尖を覆って固着されるように適合され、それにより、該後方心室固着タブは、該後尖と該患者の心臓の心室壁との間に着座させられる、請求項1に記載の人工心臓弁。
- 1つ以上の人工弁尖の少なくとも一部分は、組織または合成材料を備える、請求項1に記載の人工心臓弁。
- 前記アンカーの前方部分に連結される整列要素をさらに備え、該整列要素は、前記患者の心臓の大動脈起始部と整列させられ、該患者の僧帽弁の前尖の2つの線維性三角の間に配置されるように適合される、請求項1に記載の人工心臓弁。
- 前記人工心臓弁は、それに連結される治療薬をさらに備え、該治療薬は、そこから溶出されるように適合される、請求項1に記載の人工心臓弁。
- 前記三角固着タブは、前記心室スカートが完全に配備される前に完全に配備される、請求項1に記載の人工心臓弁。
- 前記三角固着タブは、2つの支柱を備え、該2つの支柱は、前記心室スカートから始まり、丸みを帯びたU字形接続により接合されている、請求項1に記載の人工心臓弁。
- 前記アンカーの中心軸に向かって半径方向内向きに延在する複数の交連柱をさらに備え、該交連柱は、複数の相互接続した支柱から形成されている、請求項1に記載の人工心臓弁。
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2016185404A (ja) * | 2010-05-05 | 2016-10-27 | ニオバスク ティアラ インコーポレイテッド | 経カテーテル人工僧帽弁 |
US10449042B2 (en) | 2010-05-05 | 2019-10-22 | Neovasc Tiara Inc. | Transcatheter mitral valve prosthesis |
US11419720B2 (en) | 2010-05-05 | 2022-08-23 | Neovasc Tiara Inc. | Transcatheter mitral valve prosthesis |
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