JP2002523177A - 経心筋インプラント - Google Patents
経心筋インプラントInfo
- Publication number
- JP2002523177A JP2002523177A JP2000567153A JP2000567153A JP2002523177A JP 2002523177 A JP2002523177 A JP 2002523177A JP 2000567153 A JP2000567153 A JP 2000567153A JP 2000567153 A JP2000567153 A JP 2000567153A JP 2002523177 A JP2002523177 A JP 2002523177A
- Authority
- JP
- Japan
- Prior art keywords
- implant
- myocardial
- coronary
- crown
- myocardium
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/94—Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
-
- 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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
-
- 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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/064—Blood vessels with special features to facilitate anastomotic coupling
-
- 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
- A61F2/2493—Transmyocardial revascularisation [TMR] devices
-
- 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
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
-
- 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
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
-
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
- A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
- A61B2017/00252—Making holes in the wall of the heart, e.g. laser Myocardial revascularization for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
-
- 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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- 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
- A61F2/958—Inflatable balloons for placing stents or stent-grafts
-
- 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
- A61F2002/828—Means for connecting a plurality of stents allowing flexibility of the whole structure
-
- 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
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/91533—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
-
- 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
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
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- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/9155—Adjacent bands being connected to each other
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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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/9155—Adjacent bands being connected to each other
- A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
Landscapes
- Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Cardiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Optics & Photonics (AREA)
- Physics & Mathematics (AREA)
- Gastroenterology & Hepatology (AREA)
- Pulmonology (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
- Lubricants (AREA)
- Mechanical Coupling Of Light Guides (AREA)
- Electrotherapy Devices (AREA)
Abstract
Description
インプラントに関する。より具体的には、本発明は、前記インプラント内面で細
胞の治癒層形成を改善することを目的として設計されたそのようなインプラント
に関する。
書および、1997年6月25日に出願された同時係属中の米国特許出願第08
/882,397号明細書の名称は「冠状バイパス手術の方法および装置(Metho
d and Apparatus for Performing Coronary Bypass Surgery)」で、これらは共
通の譲受人によって所有され、発明者であるMark B. KnudsonおよびWilliam L.
Giese(PCT国際出願公開番号WO 98/06356として公開)の名前で出
願されたもので、いずれも、心室から冠状血管の管腔への直接的な血流用導管を
設けるためのインプラントを教示している。ある実施態様では、L字型のインプ
ラントを冠状動脈の管腔内に収め、心筋層を介して心臓の左心室内まで延ばす。
その導管は剛性(rigid)で開いたままなので、心収縮と心拡張のいずれの間でも
血流が導管を流れることができる。前記導管の開口部上での組織増殖および閉塞
を防止するため、前記導管は左心室内に突出している。前記‘682特許および
前記‘397出願は、前記インプラントの、心臓壁を通過する部分がポリエステ
ル(ダクロン(Dacron、登録商標)等)で裏張り(line)された開口構造部材である
という実施態様についても述べている。さらに別の実施態様では、前記インプラ
ントの、冠状血管内にある部分が、開口隔室バルーン拡大型のステント(an open
cell, balloon-expandable stent)であることも開示している。
書では、つぶれた状態で血管系を通過し、心筋層に配置されると拡大して、冠状
動脈や左心室まで延びないようになっているインプラントを教示している。前記
インプラントは、心臓の周期(例えば、図7Aおよび7Bの実施態様における心
拡張の間または、図2Aおよび2Bの実施態様における心収縮の間)毎に一回閉
鎖する。これら2種類の設計のいずれかを移植片で裏張りしてもよい。
願日は1997年10月6日で、名称は「経心筋インプラント(Transmyocardial
Implant)」であり、発明者のKatherine S. Tweden、Guy P. VanneyおよびThoma
s L. Odlandの名前で出願されたものであるが、この出願は、前記‘397出願
および‘682特許と同様のインプラントの固定構造を改善したインプラントを
教示している。その改善された固定構造においては、組織が前記インプラントの
外部表面で増殖し易いように導管の少なくとも一部に巻き付けられた布を含む。
成する突出型ステントを開示している。そのステントはワイヤーメッシュもしく
はその他の金属またはポリマー材料として記載され、自己拡大型(self-expandin
g)、または加圧拡大型(pressure expandable)であってもよい。前記出願におい
ては、前記ステントが、ポリエステル、ポリエステル織布、ポリテトラフルオロ
エチレン、膨張型(expanded)ポリテトラフルオロエチレン、ポリウレタン、シリ
コーン、ポリカーボネート、自己由来組織および異種移植組織を含む材料の、部
分的または全体的な管状カバリングで覆われていてもよいと記載されている。
および血小板活性化の発生率(incidence)が低い材料(チタンまたは熱分解炭素
等)で形成される。そのような材料は様々な製品(心臓弁の構成部分等)で使用
可能であることが証明されているが、完治を促進するものではない。「治癒(hea
ling)」とは、経時的に、患者の細胞がインプラントの材料を覆うように増殖し
、その結果前記インプラントを流れる血液が、異物ではなく患者の細胞のみに(
または少なくとも、主として患者の細胞に)露出されることを意味する。
に心筋層を介して血流路を確保する経心筋インプラントが開示されている。前記
インプラントは血管内に収まるサイズの冠部を持つ。心筋部は、心筋層を介して
心室に達するサイズになっている。切替部は前記冠部および心筋部を接続して、
前記心筋部からの血流を前記冠部に向ける。前記冠部と前記心筋部は開口構造に
なっているため、組織が前記冠部と前記心筋部の壁厚方向に増殖できる。前記心
筋部は、凝固カスケードと血小板活性化を抑制し治癒を促進する物質を含む。
記導管10は、チタンまたはその他の生体適合性材料で形成してもよい。前記導
管10の材料は、心筋の収縮力に耐えられるような半径方向に剛性である材料で
あるのが好ましい。限定しない例によれば、前記管は、外径DOを約3ミリメー
トル、内径DIを約2.5ミリメートルとし、壁厚は約0.25ミリメートルで
与えられる。
管腔80といった、冠状血管の管腔に収まるサイズの冠部12を持つ。前記導管
10は、前記冠部12の軸に対し直角に延びている心筋部14を持つ。前記心筋
部14は前記冠状動脈82から前記心筋層84を介して直接的に延びており、患
者の心臓の左心室83内に突出するサイズである。
10の内部20につながる第二開口部18を持つ。従って、血液は前記左心室8
3と前記冠状動脈82の前記管腔80の間を、前記インプラント10を介して自
由に流れることができる。血液は管腔80の軸に平行方向に開口部16から軸方
向に流れ出す。
糸24によって前記動脈82を前記冠部12に固定する。冠状動脈の近位部82
aは縫合糸85で結紮されている。
びている複数の開口隔室12b、14bを明確にする開口格子構造(open lattic
e construction)12a、14aを有する。前記冠部12と前記心筋部14は、
12、14間の、90゜に曲がった切替部13で結合されているのが好ましい。
切替部13は、部位12、14と同様に開口格子構造を有していてもよいが、そ
のような開口構造の場合、切替部13の開口面積はより小さいことが好ましく、
また、図示されているように、立体的構造であっても良い。そのような構造であ
れば、前記心筋部14から前記冠部12へ高速で流れる血液を前記切替部で方向
転換させることができる。大きな開口隔室を持つ格子構造が前記切替部にあると
、高速流が前記切替部を覆っている組織(図示せず)を損傷する恐れがある。
性ユニットとして最終サイズで形成するか、または直径を小さくして形成し後で
標準サイズまで拡大することもできる。例えば、図3に、切替部13'から直径
を小さくした開口端16'まで徐々に細くなるように形成されている冠部12'を
示す。徐々に細くなるおかげで、冠状動脈への挿入が容易になる。そのような挿
入後、前記先端が細くなった冠部12'を、図3の破線で示されている標準サイ
ズにまで拡大してもよい。ステント血管形成術で従来より行われているように、
先端にバルーンの付いたカテーテルを用いてそのような拡大を実施することも可
能である。つぶされ、、後に拡大され、そこで12、13、14のすべての部分
が拡大されたインプラント10は、経皮的に配置したインプラントとして使用可
能である。本願の図面に、外科用として現在好ましく使用されるインプラントを
示す。外科的な適用例では、前記動脈82は結紮される。前記インプラント10
は、前記動脈82の側面で心外膜および心筋層に通す。
ン100から出ているリード102は、切替部13'の開口部113'を通過する
。前記開口部113'は、前記バルーン100およびリード102を開口部11
3'から引き抜いた後、プラグ115'で閉鎖可能である。あるいは、開口隔室構
造の切替部13"では(図4)、バルーンリードを切替部113"の開口部に通す
こともできる。図6は、心筋部の開口部18から前記リード102を通すところ
である。前記リード102は、前記バルーン100を取り除くために、心臓の外
部から上向きに引張ることができる。あるいは、前記リード102を左心室の端
部18付近にあるカテーテル(図示せず)を介して引張ることもできる。
13(ステント格子構造にすれば達成可能)であれば、前記冠部を確実に前記管
腔80に対し軸方向に揃えて配置するように、前記冠部12と前記心筋部14の
間を相対的に結合できる。そのような結合を行わない場合、移植後に前記冠部1
2が前記管腔80に対し軸方向に揃って配置されるように前記心筋部14の位置
を正確に制御すれば、そのように軸方向に揃えて配置させることが達成される。
室12c、14cを通って増殖することを可能にする。前記冠部12における治
癒過程は冠状ステントの場合と同じである。血管内皮細胞が増殖して前記冠部1
2の構造材料12aを覆うのである。
る。その上、心筋層では血栓形成率が高い(highly thrombogenic)。従って、前
記心筋層82とインプラントの内部20を無制限に接触させると、インプラント
10の血栓症につながる恐れがある。さらに、心外膜(すなわち、心筋層の外層
)の方が、治癒に役立つ心筋層増殖細胞の密度が高いと信じられている。
中に与える。前記ライナー30は、組織の増殖を容認する任意の多孔性材料であ
り、好ましくはポリエステル布(ダクロン等)である。前記多孔性ライナー30
は、前記開口隔室12c、14cより小さい内側の格子間空間(interstial spac
e)を有する。前記ライナー30は前記心筋部14の内面に示しているが、同時に
、または代わりに外部を取り囲んでいてもよい。
心筋部14の上端に固定されたその上端32を有する。下端34は前記心筋部1
4の開口部上で折り曲げられ、縫合糸36で前記部位14の外部に固定されてい
る。前記心筋部14は、前記左心室83の内部に露出されたライナー材料の上で
折り曲げられている個所のみが、前記左心室83内部に突出するようなサイズと
なっている。
血栓を予防するために、前記ライナー30には凝固カスケード、血小板活性化お
よび癒着(adhesion)を抑制する物質を含浸させている。そのような物質の一例と
してヘパリンが挙げられるが、それ以外の任意の抗凝固剤または抗血小板剤であ
ってもよい。また、治癒を早める目的で、塩基性(basic)繊維芽細胞生長因子の
ような物質を使用することもできる。
ることを可能にする。血栓形成を抑制しないでおくと、インプラントの閉塞を起
こす恐れもある。開口構造により、前記心外膜の構造的治癒用細胞がライナー表
面にまで増殖可能である。その結果、内皮細胞が構造細胞表面で増殖することが
できる。
、凝固および血小板活性化を最小限に抑えることにより治癒を制御する。そうし
なければ、心筋層からの物質によって凝固および血小板活性化が刺激される恐れ
がある。第二段階では、構造細胞が、血栓で裏張りされたライナー30内および
表面で増殖し、それによって初めて治癒および血管床形成を行う。そして第三段
階では、内皮細胞が構造細胞表面で増殖する。
組織増殖が可能になる。そのような増殖は、立体構造でも起こり得る。あるいは
、前記ライナー30を前記切替部13内まで延長してもよい。加えて、前記切替
部13の開口隔室構造によって、前記冠部と前記心筋部との間の関節接合を可能
にすることができる。そのような構造を図4に示す。開口切替部13"を、前記
冠部12"と前記心筋部14"間のコイル13a"によって形成する。この構造に
より、前記切替部で曲げることが可能になる。その結果、最初に前記心筋部を正
確に位置合わせしなくても、前記冠部を動脈に軸方向に揃えて配置できる。
有する通常の当業者が変更例および均等物を作成することが可能と考えられる。
そのような変更例は当然、付随する請求項の範囲内に含まれると解釈されるべき
である。例えば、前記ライナー30は、PTFE、膨張PTFE、ポリウレタン
、ポリプロピレン、または任意の生体適合性の舗装(paving)材料または天然組織
を含む多くの構造をとることが可能である。さらに、放射線治療(例えば前記冠
部に、半減期の短いβ放射体を供給する)によって前記冠部12の再狭窄を予防
することもできる。また、前記ライナー30は、吸収性材料であっても非吸収性
材料であってもよい。遺伝子操作した細胞を形質転換させて抗凝固剤およびその
他の物質を分泌することで(例えば、組織プラスミノーゲン活性化因子および硝
酸を発するよう形質変化させた平滑筋細胞)、血流(blood fluid)を維持するこ
ともできる。
を設けた状態で示す側面図。
ントの別の実施態様図。
ルを示す、図3の別の実施態様の側断面図。
大型インプラントの側断面図。
Claims (17)
- 【請求項1】 左心室から冠状血管まで直接的に血流路を設ける(define)経心
筋インプラント(transmyocardial implant)であり、 血管内に収まるサイズの冠部(coronary portion)と、心筋層を介して左心室に達
するサイズの心筋部(myocardial portion)と、前記冠部および心筋部を接続して
前記心筋部から前記冠部へ血流を向ける切替部(transition portion)とを備え、
少なくとも前記冠部と前記心筋部が開口構造(open construction)となっている
ため、前記冠部および前記心筋部の壁厚方向に組織増殖可能であり、少なくとも
前記心筋部が、凝固カスケード(coagulation cascade)および血小板活性化(plat
elet activation)を抑制する物質(agent)を含むインプラント。 - 【請求項2】 治癒(healing)を促進する物質をさらに含む請求項1に記載の
インプラント。 - 【請求項3】 少なくとも前記心筋部に多孔性裏層(porous lining)をさらに
備え、その多孔性裏層が、前記心筋部の前記開口構造の開口部(opening)より小
さい孔(pore)を有する請求項1に記載のインプラント。 - 【請求項4】 前記多孔性裏層が前記物質を含有する請求項1に記載のインプ
ラント。 - 【請求項5】 前記物質がヘパリンである請求項1に記載のインプラント。
- 【請求項6】 前記物質が抗凝固剤である請求項1に記載のインプラント。
- 【請求項7】 前記物質が抗血小板剤(anti-platelet)である請求項1に記載
のインプラント。 - 【請求項8】 前記治癒促進物質が増殖因子である請求項2に記載のインプラ
ント。 - 【請求項9】 前記冠部を第一直径からより大きい第二直径まで拡大可能な請
求項1に記載のインプラント。 - 【請求項10】 前記心筋部を第一直径からより大きい第二直径まで拡大可能
な請求項1に記載のインプラント。 - 【請求項11】 前記切替部によって前記冠部と前記心筋部間の関節接合(art
iculation)が可能になる請求項1に記載のインプラント。 - 【請求項12】 左心室から冠状血管まで直接的に血流路を設ける経心筋イン
プラントであり、 血管内に収まるサイズの冠部と、心筋層を介して左心室に達するサイズの心筋部
と、前記冠部および心筋部を接続して前記心筋部から前記冠部へ直接血流を通す
切替部とを備え、 前記心筋部が、組織の一体化を促進する(facilitate)構造を含み、また凝固カス
ケードと血小板活性化を抑制する物質を含むインプラント。 - 【請求項13】 前記冠部が、前記冠部に沿って血管内皮細胞が増殖するのを
促進する開口構造を含む請求項12に記載のインプラント。 - 【請求項14】 前記心筋部が、前記心筋部内に向けて血管内皮細胞が増殖す
るのを促進する多孔性構造を含む請求項12に記載のインプラント。 - 【請求項15】 前記多孔性構造が布ライナー(fabric liner)を含む請求項1
4に記載のインプラント。 - 【請求項16】 前記心筋部が、構造細胞(structural cell)が前記心筋部内
部に向けて増殖するのを促進する壁構造をさらに含む請求項14に記載のインプ
ラント。 - 【請求項17】 前記壁構造が前記心筋部の開口隔室構造(open cell constru
ction)である請求項16に記載のインプラント。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/141,284 | 1998-08-27 | ||
US09/141,284 US6406488B1 (en) | 1998-08-27 | 1998-08-27 | Healing transmyocardial implant |
PCT/US1999/019208 WO2000012029A1 (en) | 1998-08-27 | 1999-08-24 | Transmyocardial implant |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2002523177A true JP2002523177A (ja) | 2002-07-30 |
JP2002523177A5 JP2002523177A5 (ja) | 2006-10-05 |
Family
ID=22495012
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2000567153A Pending JP2002523177A (ja) | 1998-08-27 | 1999-08-24 | 経心筋インプラント |
Country Status (11)
Country | Link |
---|---|
US (4) | US6406488B1 (ja) |
EP (2) | EP1516599A3 (ja) |
JP (1) | JP2002523177A (ja) |
AT (1) | ATE284182T1 (ja) |
AU (1) | AU5686999A (ja) |
CA (1) | CA2341521A1 (ja) |
DE (1) | DE69922514T2 (ja) |
DK (1) | DK1107710T3 (ja) |
ES (1) | ES2235505T3 (ja) |
PT (1) | PT1107710E (ja) |
WO (1) | WO2000012029A1 (ja) |
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- 1999-08-24 DE DE69922514T patent/DE69922514T2/de not_active Expired - Fee Related
- 1999-08-24 DK DK99943852T patent/DK1107710T3/da active
- 1999-08-24 AT AT99943852T patent/ATE284182T1/de not_active IP Right Cessation
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- 1999-08-24 PT PT99943852T patent/PT1107710E/pt unknown
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DE69922514T2 (de) | 2005-12-15 |
ATE284182T1 (de) | 2004-12-15 |
US6406488B1 (en) | 2002-06-18 |
US20040077988A1 (en) | 2004-04-22 |
EP1107710B1 (en) | 2004-12-08 |
DE69922514D1 (de) | 2005-01-13 |
US20060052736A1 (en) | 2006-03-09 |
ES2235505T3 (es) | 2005-07-01 |
AU5686999A (en) | 2000-03-21 |
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