JP4782121B2 - 2軸配向ポリマーを用いた埋め込み型医療機器の製造方法 - Google Patents
2軸配向ポリマーを用いた埋め込み型医療機器の製造方法 Download PDFInfo
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/25—Component parts, details or accessories; Auxiliary operations
- B29C48/30—Extrusion nozzles or dies
- B29C48/32—Extrusion nozzles or dies with annular openings, e.g. for forming tubular articles
- B29C48/33—Extrusion nozzles or dies with annular openings, e.g. for forming tubular articles with parts rotatable relative 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
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- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by 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
- 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
- A61F2002/825—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having longitudinal struts
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
- B23K—SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
- B23K2103/00—Materials to be soldered, welded or cut
- B23K2103/30—Organic material
- B23K2103/42—Plastics
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
- B23K—SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
- B23K2103/00—Materials to be soldered, welded or cut
- B23K2103/50—Inorganic material, e.g. metals, not provided for in B23K2103/02 – B23K2103/26
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/001—Combinations of extrusion moulding with other shaping operations
- B29C48/0018—Combinations of extrusion moulding with other shaping operations combined with shaping by orienting, stretching or shrinking, e.g. film blowing
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
- B29C48/09—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/42—Component parts, details or accessories; Auxiliary operations
- B29C49/78—Measuring, controlling or regulating
- B29C49/786—Temperature
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
- B29L2031/7532—Artificial members, protheses
- B29L2031/7534—Cardiovascular protheses
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Vascular Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Manufacturing & Machinery (AREA)
- Mechanical Engineering (AREA)
- Surgery (AREA)
- Epidemiology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
- Extrusion Moulding Of Plastics Or The Like (AREA)
Description
Claims (36)
- 第2環状部材の内部に配置された第1環状部材を備え、生体吸収性ポリマーが環状膜としてそれらの環状部材の間の環状空胴を通って運ばれる成形装置の中に、前記生体吸収性ポリマーを送り込む工程と、
周方向の流動を引き起こす前記環状膜を放射状に拡張する工程と、
前記拡張された環状膜からチューブを形成する工程と、
生体吸収性ポリマーチューブから、相互に連結された支柱の網を有するバルーン拡張式のステント足場を製造する工程と、
を備えるステント足場の製造方法。 - 前記環状膜を前記装置から出た後に拡張する、請求項1に記載の方法。
- 前記環状膜は、選択された圧力の下、ガスによって拡張される、請求項1に記載の方法。
- 前記ガスは、第1環状部材の内側にある第2環状部材を通って運ばれる、請求項3に記載の方法。
- ステント足場の望ましい性質を得るために、前記ガスの圧力を制御する工程をさらに備える、請求項3に記載の方法。
- ステント足場の望ましい性質を得るために、前記環状膜の温度を制御する工程をさらに備える、請求項1に記載の方法。
- 前記拡張された環状膜の温度は、前記ポリマーの融解温度よりも高い、請求項1に記載の方法。
- 前記拡張された環状膜を、望ましい直径にまで引っ張る工程をさらに備える、請求項1に記載の方法。
- 前記拡張された環状膜を、周囲温度で、もしくは実質的に周囲温度で冷却する工程をさらに備える、請求項1に記載の方法。
- 前記拡張された環状膜を、周囲温度よりも低い温度で冷却する工程を備える、請求項1に記載の方法。
- 第1の直径から第2の直径まで、生体吸収性ポリマーチューブをその円筒軸の周りに放射状に拡張する工程であって、前記生体吸収性ポリマーチューブは可塑的に拡張される工程と、
前記生体吸収性ポリマーチューブから、相互に連結された支柱の網を有するバルーン拡張式のステント足場を製造する工程と、を備えるステント足場の製造方法。 - 前記チューブはポリマーから成り、前記拡張中のチューブの温度は、ポリマーのガラス転移温度以上、ポリマーの融解温度以下である、請求項11に記載の方法。
- 前記拡張されたチューブを冷却する工程をさらに備える、請求項11に記載の方法。
- 前記拡張されたチューブを冷却する工程は、周囲温度よりも低い温度で前記拡張されたチューブを冷却する工程を備える、請求項13に記載の方法。
- 前記拡張されたチューブを冷却する工程は、周囲温度、または実質的に周囲温度で、前記拡張されたチューブを冷却する工程を備える、請求項13に記載の方法。
- 前記チューブの放射状拡張がチューブ内の周方向の分子配向を引き起こす、請求項11に記載の方法。
- 第2環状部材の内部に配置された第1環状部材を備え、生体吸収性ポリマーが環状膜としてそれらの環状部材の間の環状空胴を通って運ばれる成形装置の中に、前記生体吸収性ポリマーを送り込む工程と、
前記環状膜内において周方向の流動を引き起こす工程と、
前記環状膜から生体吸収性チューブを形成する工程と、
生体吸収性ポリマーチューブから、相互に連結された支柱の網を有するバルーン拡張式のステント足場を製造する工程と、を備えるステント足場の製造方法。 - 前記送り込まれるポリマーの温度は前記ポリマーの融解温度よりも高い、請求項1又は17に記載の方法。
- 前記送り込まれるポリマーの温度は、前記ポリマーの融解温度よりも低い温度であって、前記成形装置は前記ポリマーを溶解するよう構成されている、請求項1又は17に記載の方法。
- 前記ポリマーが、前記ポリマーと溶媒との混合物の中に送り込まれる、請求項1又は17に記載の方法。
- 前記環状膜の温度は、前記ポリマーの融解温度よりも高い、請求項1又は17に記載の方法。
- 前記チューブの温度は、前記ポリマーの融解温度よりも低い、請求項17に記載の方法。
- 前記成形装置は、押出し成形機を備える、請求項17に記載の方法。
- 前記周方向の流動が、前記第1環状部材および/または前記第2環状部材を回転させることによって前記環状膜内で引き起こされる、請求項17に記載の方法。
- 前記周方向の流動が、回転する前記第1環状部材の表面の少なくとも一部分のらせん状のチャンネルにより前記環状膜内で引き起こされる、請求項24に記載の方法。
- 前記周方向の流動が、回転する前記第2環状部材の表面の少なくとも一部分のらせん状のチャンネルにより前記環状膜内で引き起こされる、請求項24に記載の方法。
- 前記周方向の流動が、前記環状膜の少なくとも一部分を回転させるよう構成されている第3環状部材を覆ってまたはその内側に配置された前記成形装置の外側にある前記環状膜の少なくとも一部分で、前記環状膜内において引き起こされる、請求項17に記載の方法。
- 前記周方向の流動が、前記チューブを回転させることにより環状膜内において引き起こされる、請求項17に記載の方法。
- 前記チューブが、前記チューブを回転させるよう構成された第3環状部材を覆ってまたはその内側に前記チューブを設置することにより回転される、請求項28に記載の方法。
- 前記周方向の流動が、前記成形装置の外側にある前記第1環状部材の少なくとも一部分で、前記成形装置の外側の前記環状膜において引き起こされる、請求項17に記載の方法。
- 前記第1環状部材の回転が、前記成形装置の外側の環状膜の少なくとも一部分への周方向の流動を引き起こす請求項30に記載の方法。
- 前記環状膜の周方向の流動が、環状膜内における周方向の分子配向を引き起こす、請求項17に記載の方法。
- 前記ステント足場における周方向の強度を得るために、引き起こされる周方向の流動を制御する工程をさらに備える、請求項17に記載の方法。
- 前記環状膜を冷却するに先立って、望ましい直径にまで前記環状膜を引き延ばす工程をさらに備える、請求項17に記載の方法。
- 周囲温度またはその付近の温度で前記環状膜を冷却する工程をさらに備える、請求項17に記載の方法。
- 周囲温度よりも低い温度で前記環状膜を冷却する工程をさらに備える、請求項17に記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/899,948 US20060020330A1 (en) | 2004-07-26 | 2004-07-26 | Method of fabricating an implantable medical device with biaxially oriented polymers |
US10/899,948 | 2004-07-26 | ||
PCT/US2005/025759 WO2006014747A1 (en) | 2004-07-26 | 2005-07-20 | Method of fabricating an implantable medical device with biaxially oriented polymers |
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Publication Number | Publication Date |
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JP2008507439A JP2008507439A (ja) | 2008-03-13 |
JP2008507439A5 JP2008507439A5 (ja) | 2008-09-04 |
JP4782121B2 true JP4782121B2 (ja) | 2011-09-28 |
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US (4) | US20060020330A1 (ja) |
EP (1) | EP1773566B1 (ja) |
JP (1) | JP4782121B2 (ja) |
WO (1) | WO2006014747A1 (ja) |
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- 2005-07-20 EP EP05773427.9A patent/EP1773566B1/en not_active Not-in-force
- 2005-07-20 WO PCT/US2005/025759 patent/WO2006014747A1/en active Application Filing
- 2005-07-20 JP JP2007523649A patent/JP4782121B2/ja not_active Expired - Fee Related
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Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
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JPS62122736A (ja) * | 1985-08-12 | 1987-06-04 | Mitsui Petrochem Ind Ltd | インフレ−シヨンフイルム、その製法と装置 |
JPS62158017A (ja) * | 1985-12-24 | 1987-07-14 | ゼロツクス コ−ポレ−シヨン | 肉薄管の製造装置及び方法 |
JP2004515581A (ja) * | 2000-11-30 | 2004-05-27 | ザ プロクター アンド ギャンブル カンパニー | 高分子量ポリオレフィン及び該ポリオレフィンの重合のための触媒及び方法 |
US20030226833A1 (en) * | 2001-02-15 | 2003-12-11 | Scimed Life Systems, Inc. | Laser cutting of stents and other medical devices |
Also Published As
Publication number | Publication date |
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EP1773566B1 (en) | 2016-08-31 |
US20120217672A1 (en) | 2012-08-30 |
US8715564B2 (en) | 2014-05-06 |
US20140228929A1 (en) | 2014-08-14 |
WO2006014747A1 (en) | 2006-02-09 |
EP1773566A1 (en) | 2007-04-18 |
US20060020330A1 (en) | 2006-01-26 |
JP2008507439A (ja) | 2008-03-13 |
US8192678B2 (en) | 2012-06-05 |
US20110079941A1 (en) | 2011-04-07 |
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