JP4996578B2 - 多孔性構造体を具備する医療用装置又は器具 - Google Patents
多孔性構造体を具備する医療用装置又は器具 Download PDFInfo
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- JP4996578B2 JP4996578B2 JP2008277114A JP2008277114A JP4996578B2 JP 4996578 B2 JP4996578 B2 JP 4996578B2 JP 2008277114 A JP2008277114 A JP 2008277114A JP 2008277114 A JP2008277114 A JP 2008277114A JP 4996578 B2 JP4996578 B2 JP 4996578B2
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- Prior art keywords
- inflow cannula
- porous structure
- blood
- porous
- support
- 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.)
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
- A61L29/146—Porous materials, e.g. foams or sponges
-
- 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
-
- 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
- A61M1/3659—Cannulae pertaining to extracorporeal circulation
-
- 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
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
- A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
-
- 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
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
- A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
-
- 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
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/247—Positive displacement blood pumps
- A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
- A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
Description
(a)線条を管状の芯材に、一方の端から他方の端まで螺旋状に巻き付ける工程、
(b)工程(a)で巻き付けた螺旋と交差させるように、同じか又は別の線条を螺旋状に巻き付ける工程、
(c)工程(a)および(b)により得られた管状構造体の焼結を行う工程、
(d)工程(c)で得られた焼結された管状構造体から、上記の芯材を抜き取る工程、必要に応じて上記(a)〜(d)に加えて下記の(e)および/又は(f):
(e) 工程(d)で得られた管状構造体の半径方向内側に、該構造体の内部に嵌め込み得るようにかつそうして該構造体を支持し得るように外径が適合された管状の非孔性支持体を嵌め込む工程、および/又は
(f) 工程(d)で得られた管状構造体又は工程(e)で得られた非孔性支持体付きの管状構造体全体に抗血栓性コーティングを施す工程、
を含む、インフローカニューレを製造する方法に関する。
(a) 台座と、その上に同心円状に配置された内型枠および外型枠とを具備する型枠内に、線条を不規則に入れてその後固定し、不織体からなる管状構造体を得る工程、必要に応じて上記(a)に加えて下記の(b)および/又は(c):
(b) 工程(a)で得られた管状構造体の半径方向内側に、該構造体の内部に嵌め込み得るようにかつそうして該構造体を支持し得るように外径が適合された管状の非孔性支持体を嵌め込む工程、および/又は
(c) 工程(a)で得られた管状構造体又は工程(b)で得られた非孔性支持体付きの管状構造体全体に抗血栓性コーティングを施す工程、
を含む、インフローカニューレを製造する方法に関する。
- MPCをエタノールで希釈して0.1〜10重量%、好ましくは0.5重量%MPCエタノール溶液を調製する、
- 該溶液に、作製された多孔性構造体を室温で1〜60分間、好ましくは5〜10分間浸漬する、
- 該構造体を溶液から取り出し室温で乾燥する。
- 上記多孔性構造体の平均的な幾何学形状(例えば、半径方向に均一な厚みを有する中空の円柱)を仮定して該幾何学形状の体積(V1)を数学的に算出する、
- 実際に線条を用いて製造した構造体又は実際の多孔性成形体の重量を測定する、
- 上記構造体の線条又は多孔性成形体部分の体積(V2)を上記の重量と上記線条又は上記成形体の比重とから求める、
- 仮定した幾何学形状の体積(V1)から線条又は成形体部分の体積(V2)を引くことにより、上記構造体における全空隙体積(V3)を求める、
- 上記構造体における全空隙体積(V3)を、仮定した幾何学形状の体積(V1)で除した値に100を乗じた値を空隙率(体積%)とする。
- 支持体の突き当て部が多孔性構造体に当たるまで、支持体を多孔性構造体の半径方向内側に嵌め込む、
- スリーブ、カフを順番に支持体に通し、最後にカフ押さえねじを支持体ねじ部と螺合することによって、多孔性構造体を支持体上に固定する。
[発明の効果]
1b 非孔性支持体付きのインフローカニューレ
1c 非孔性支持体を持たないインフローカニューレ
2 本体
3 支持体
3a 支持体胴部
3b 支持体突き当て部
3c 支持体ねじ部
4 スリーブ
5 カフ
6 カフ押さえねじ
7 人工血管
8 外クランプ
9 内クランプ
10 導管アセンブリ
11 血液ポンプ
12 ポンプケーブル
13 コントローラ
14 バッテリ
15 アウトフローグラフト
16 患者
17 胸部腔
18 コネクタ
18a 本発明の多孔性構造体
19 保持リング
Claims (8)
- 一部又は全体が多孔性構造体からなる血液循環補助装置用インフローカニューレであって、この多孔性構造体がポーラス金属からなる多孔性成形体からなる、上記インフローカニューレ。
- 上記多孔性構造体が、1.9×10−5mm2〜20mm2の開口面積を有する孔を含む、請求項1記載のインフローカニューレ。
- 多孔性成形体表面に抗血栓性コーティングが施されている、請求項1又は2のいずれか1つに記載のインフローカニューレ。
- 半径方向内側に管状の非孔性支持体をさらに具備する、請求項1〜3のいずれか1つに記載のインフローカニューレ。
- 上記非孔性支持体が、それの一方の端部に突き当て(リム)部を有する、請求項4記載のインフローカニューレ。
- 上記血液循環補助装置が補助人工心臓装置である、請求項1〜5のいずれか1つに記載のインフローカニューレ。
- 請求項1〜6のいずれか1つに記載のインフローカニューレを含む導管アセンブリ。
- 請求項7に記載の導管アセンブリを備えた補助人工心臓装置。
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2008277114A JP4996578B2 (ja) | 2008-10-28 | 2008-10-28 | 多孔性構造体を具備する医療用装置又は器具 |
EP09823230.9A EP2349380B1 (en) | 2008-10-28 | 2009-09-24 | Medical device or instrument having porous structure |
PCT/JP2009/004826 WO2010050114A1 (en) | 2008-10-28 | 2009-09-24 | Medical device or instrument having porous structure |
US13/126,451 US9387278B2 (en) | 2008-10-28 | 2009-09-24 | Medical device or instrument having porous structure |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2008277114A JP4996578B2 (ja) | 2008-10-28 | 2008-10-28 | 多孔性構造体を具備する医療用装置又は器具 |
Related Child Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2010002934A Division JP5380312B2 (ja) | 2010-01-08 | 2010-01-08 | 多孔性構造体を具備する医療用装置又は器具 |
JP2010158037A Division JP5302273B2 (ja) | 2010-07-12 | 2010-07-12 | 多孔性構造体を具備する医療用装置又は器具 |
Publications (2)
Publication Number | Publication Date |
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JP2010104428A JP2010104428A (ja) | 2010-05-13 |
JP4996578B2 true JP4996578B2 (ja) | 2012-08-08 |
Family
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JP2008277114A Active JP4996578B2 (ja) | 2008-10-28 | 2008-10-28 | 多孔性構造体を具備する医療用装置又は器具 |
Country Status (4)
Country | Link |
---|---|
US (1) | US9387278B2 (ja) |
EP (1) | EP2349380B1 (ja) |
JP (1) | JP4996578B2 (ja) |
WO (1) | WO2010050114A1 (ja) |
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2008
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2009
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- 2009-09-24 EP EP09823230.9A patent/EP2349380B1/en not_active Not-in-force
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Also Published As
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EP2349380B1 (en) | 2016-09-07 |
US9387278B2 (en) | 2016-07-12 |
JP2010104428A (ja) | 2010-05-13 |
EP2349380A4 (en) | 2013-04-03 |
EP2349380A1 (en) | 2011-08-03 |
US20110313237A1 (en) | 2011-12-22 |
WO2010050114A1 (en) | 2010-05-06 |
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