JP5856569B2 - 眼内圧を低減するためのデバイスと、それを含むキット - Google Patents
眼内圧を低減するためのデバイスと、それを含むキット Download PDFInfo
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- JP5856569B2 JP5856569B2 JP2012552089A JP2012552089A JP5856569B2 JP 5856569 B2 JP5856569 B2 JP 5856569B2 JP 2012552089 A JP2012552089 A JP 2012552089A JP 2012552089 A JP2012552089 A JP 2012552089A JP 5856569 B2 JP5856569 B2 JP 5856569B2
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- 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
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/15—Implant having one or more holes, e.g. for nutrient transport, for facilitating handling
-
- 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
- A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
-
- 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
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
- A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
-
- 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
- A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
-
- 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
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
-
- 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
- A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
- A61F2002/0081—Special surfaces of prostheses, e.g. for improving ingrowth directly machined on the prosthetic surface, e.g. holes, grooves
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
-
- 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
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
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- Health & Medical Sciences (AREA)
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- Engineering & Computer Science (AREA)
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- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Prostheses (AREA)
Description
本願は、2010年2月5日に出願された、米国仮特許出願第61/301,874号の利益を主張し、その開示は、その全体が本明細書中で参考として援用される。
本明細書中に記載されるデバイス、キット、および方法は、一般に、眼内圧低減に関する。より具体的には、上記デバイス、キット、および方法は、シュレム管を横切る流体の流れ、またはシュレム管内での流体の流れ(例えば、経管の(transluminal)流体の流れ、経壁の(transmural)流体の流れ、および長手方向の(longitudinal)流体の流れ)を実質的に妨げることなく、眼内圧を低減し得る、シュレム管に移植可能な眼内移植物に関する。
緑内障は、世界中で何百万という人に影響を及ぼす潜在的な失明病である。代表的に、緑内障は、眼内圧の上昇によって特徴付けられる。眼圧の増加は、未処置のままにした場合、永久的な視力喪失をもたらし得る、視神経への損傷を引き起こし得る。眼内圧の一貫した低減は、緑内障に関連する視力の進行性の喪失を遅らせるか、または停止し得る。さらに、患者が、緑内障をもたらしそうな症状(例えば、多少上がった眼内圧)を示すが、まだ視神経損傷の兆候を示していないとき、彼らは、しばしば前緑内障および高眼圧症と診断される。緑内障、前緑内障、および高眼圧症のための処置は、主として眼内圧の低減に努めるものである。
眼内圧を低減するためのデバイス、キット、および方法が、ここで開示される。眼内の圧力を低減するための上記デバイスは、シュレム管内の少なくともある部分において、円周方向に移植可能である支持体を含み、ここで上記支持体は、上記管の少なくともある部分の少なくとも部分的な開通性を修復または維持するために配置される。上記支持体は、上記管の内側表面との最小限の表面領域の接触を有し得る。これは、例えば、上記支持体が、上記管を横切る、経壁の、または経管の流れを実質的に妨げることなく、上記管の少なくとも部分的な開通性を修復または維持することを可能にし得る。上記支持体は、線維柱帯を横切って、シュレム管を横切って、集合管に入る良好な房水の流れを可能にし得る。上記支持体は、シュレム管の管腔の内側(inner lumen)との接触またはその閉塞を最小限にすることによって房水の流れを実質的に妨げることを避け得、それにより、房水の最大限の経壁流出を可能にする。上記支持体は、それにより、眼の天然の排液経路を利用および修復し得る。
例えば、本発明は、以下の項目を提供する:
(項目1)
眼内圧を低減するためのデバイスであって、該デバイスは:
シュレム管内の少なくともある部分において円周方向に移植可能であって、シュレム管の少なくともある部分の少なくとも部分的な開通性を修復または維持するように配置される支持体を含み、
ここで該支持体は、リボン部材を含む、
デバイス。
(項目2)
上記リボン部材が少なくとも1つの穴を含む、項目1に記載のデバイス。
(項目3)
上記リボン部材がねじられる、項目2に記載のデバイス。
(項目4)
上記リボン部材がねじられる、項目1に記載のデバイス。
(項目5)
項目1に記載のデバイスであって、ここで上記リボン部材が第一の細長いエッジおよび第二の細長いエッジを含み、該第一および第二の細長いエッジは、該デバイスがシュレム管に移植されるときにシュレム管の内側表面と接触するように配置される、デバイス。
(項目6)
項目5に記載のデバイスであって、ここで上記第一および第二の細長いエッジは、該デバイスがシュレム管に移植されるときにシュレム管の上記内側表面と連続して接触するように配置される、デバイス。
(項目7)
項目1に記載のデバイスであって、ここで該デバイスがシュレム管に移植されるときに、該デバイスは、シュレム管を横切る経壁の流れを実質的に妨げない、デバイス。
(項目8)
上記リボン部材が平らである、項目1に記載のデバイス。
(項目9)
上記支持体が形状記憶合金を含む、項目1に記載のデバイス。
(項目10)
上記形状記憶合金がニッケル−チタン合金を含む、項目9に記載のデバイス。
(項目11)
上記支持体が金属合金を含む、項目1に記載のデバイス。
(項目12)
上記金属合金がステンレス鋼を含む、項目11に記載のデバイス。
(項目13)
上記支持体が金属を含む、項目1に記載のデバイス。
(項目14)
上記金属がチタンを含む、項目13に記載のデバイス。
(項目15)
眼内圧を低減するための方法であって、該方法は:
リボン部材を含む第一の支持体をシュレム管内で円周方向に挿入する工程を含み、
ここで該第一の支持体は、シュレム管の少なくともある部分の開通性を維持し、シュレム管を横切る経壁の流れを実質的に妨げない、
方法。
(項目16)
上記方法が、上記第一の支持体がシュレム管内に完全に含まれるように、該第一の支持体を挿入する工程を含む、項目15に記載の方法。
(項目17)
上記第一の支持体がシュレム管の中心コアの少なくともある部分を通る、項目15に記載の方法。
(項目18)
上記第一の支持体がシュレム管の上記中心コアを完全に通る、項目17に記載の方法。
(項目19)
項目15に記載の方法であって、ここで上記第一の支持体が、シュレム管の第一および第二の内側壁部と接触し、該第一の内側壁部は、線維柱帯の外部周辺境界と一致し、該第二の内側壁部は、そこから広がる集合管を有する、方法。
(項目20)
上記第一の支持体が、シュレム管の内側表面に順応する、項目15に記載の方法。
(項目21)
項目15に記載の方法であって、ここで上記第一の支持体が、シュレム管内に挿入される前に第一の形状、およびシュレム管内に挿入された後に第二の形状を有し、該第一の形状が、該第二の形状と異なる、方法。
(項目22)
上記第一の支持体が形状記憶合金を含む、項目21に記載の方法。
(項目23)
上記第一の支持体がニッケル−チタン合金を含む、項目22に記載の方法。
(項目24)
上記第一の支持体が、切り出しのアプローチを用いてシュレム管内に挿入される、項目15に記載の方法。
(項目25)
上記第一の支持体が、切り込みのアプローチを用いてシュレム管内に挿入される、項目15に記載の方法。
(項目26)
上記第一の支持体をシュレム管内に挿入するためにカニューレを使用する工程を含む、項目15に記載の方法。
(項目27)
上記第一の支持体がシュレム管内に配置されるときに、該第一の支持体は、シュレム管の内側表面と接線でのみ接触する、項目15に記載の方法。
(項目28)
上記第一の支持体がシュレム管内に配置されるときに、該第一の支持体は、シュレム管の内側表面と点でのみ接触する、項目15に記載の方法。
(項目29)
上記第一の支持体が、内壁表面領域Cを有するシュレム管の円柱状セクション内に配置されるときに、該第一の支持体はCの30%未満と接触する、項目15に記載の方法。
(項目30)
上記第一の支持体がCの10%未満と接触する、項目29に記載の方法。
(項目31)
上記第一の支持体がCの1%未満と接触する、項目29に記載の方法。
(項目32)
上記第一の支持体の挿入前にシュレム管を拡張する工程さらに含む、項目15に記載の方法。
(項目33)
第二の支持体をシュレム管内の円周方向に挿入する工程をさらに含む、項目15に記載の方法。
(項目34)
上記第一の支持体が、シュレム管の範囲の約1/8と約1/2との間を占める、項目15に記載の方法。
(項目35)
上記第一の支持体が、シュレム管の範囲の約1/4と約1/3との間を占める、項目15に記載の方法。
(項目36)
眼内圧を低減するためのキットであって、該キットは第一のデバイスおよび導入器を含み、
該第一のデバイスは、第一の支持体を含み、
該第一の支持体は、シュレム管内の少なくともある部分において円周方向に移植可能であって、シュレム管の少なくともある部分の少なくとも部分的な開通性を修復または維持するように配置され、リボン部材を含み、
該導入器は、該第一のデバイスをシュレム管内に送達するように配置される、
キット。
(項目37)
上記導入器がカニューレを含む、項目36に記載のキット。
(項目38)
上記導入器が、押し出し部材をさらに含む、項目37に記載のキット。
(項目39)
シュレム管内の少なくともある部分において円周方向に移植可能であって、シュレム管の少なくともある部分の少なくとも部分的な開通性を修復または維持するように配置される第二の支持体、を含む第二のデバイスをさらに含む、項目36に記載のキット。
(項目40)
上記第一のおよび第二の支持体が、異なるサイズを有する、項目39に記載のキット。
(項目41)
上記第一のおよび第二の支持体が、異なる形を有する、項目39に記載のキット。
シュレム管の少なくとも部分的な開通性(例えば、全開通性)を修復または維持し、その結果、上記管の少なくともある部分が開いているか、またはさえぎられていないことによって、眼内圧を低減するためのデバイス、キット、および方法が、ここで記載される。上記デバイス、キット、および方法は、シュレム管が崩壊しないように働くが、房水のための眼の天然の排液メカニズムを実質的に妨げない。ここでシュレム管に入る、シュレム管を横切る、シュレム管をまわる、およびシュレム管から出る、経壁の、経管の、および円周方向の、すなわち長手方向の流体の流れが起こる。いくつかのバリエーションにおいて、上記デバイスは、そのデバイスが、シュレム管内の少なくともある部分に移植されるとき、上記管の内側表面との最小限の表面領域の接触を有し得る。上記支持体は、上記管の開通性を最大限にし、他方、上記管の有孔の内壁および上記管の集合管ベースの外壁との接触を最小限にすることが可能であり得る。上記支持体は、経壁の流れ(シュレム管の内壁および外壁を横切る−すなわち、シュレム管に入る、およびシュレム管から出る)、経管の流れ(シュレム管を横切る)、および/または円周方向の、すなわち長手方向の流れ(シュレム管に沿った)を最小限に妨げるか、または一切妨げないことを示し得る。いくつかの場合において、上記デバイスは、眼への最小限の外傷で、シュレム管に移植可能であり得る。
眼内圧を低減するためのデバイスがここで記載され、ここで上記デバイスは、シュレム管の少なくともある部分の少なくとも部分的な開通性を修復または維持するように、上記管の円周方向に移植され得る支持体を含む。上記支持体は、シュレム管の中心コアの少なくともある部分を占めていても占めていなくてもよい。いくつかのバリエーションにおいて、上記支持体は、上記管を横切る、経壁の、および/もしくは経管の流れ、ならびに/またはシュレム管内での、長手方向の流れを実質的に妨げ得ない。
場合において、支持体(例えば、支持体1400)は、支持体の長さの0.5ミリメートル〜2ミリメートル毎について(例えば、1ミリメートル〜1.5ミリメートル毎に)、全360°の回転を完了し得る。例えば、支持体(例えば、支持体1400)は、支持体
の長さの約1ミリメートル毎に全360°の回転を完了し得る。支持体は、一様なねじれ
を有し得るか、または支持体のねじれの度合いは、支持体の長さに沿って変わり得る。
眼内圧を低減するためのキットが提供され、ここで上記キットは、シュレム管内に円周方向に移植することが可能であって、シュレム管の少なくともある部分の少なくとも部分的な開通性を修復または維持するように配置され得る、少なくとも1つの支持体を含む。上記支持体は、シュレム管の中心コアの少なくともある部分を占め得、そして/あるいは上記管を横切る、経壁の、もしくは経管の流れ、ならびに/または上記管内での長手方向の流れを実質的に妨げ得ない。上記キットはまた、上記管に上記支持体を移植するための導入器または送達デバイスを提供し得る。上記支持体および導入器は、上記キットにおいて包装された組み合わせで提供され得る。上記キットはまた、使用のための指示を含み得る(例えば、上記支持体を移植および検査するための)。
眼内圧を低減するための方法がまた提供される。一般に、上記方法は、支持体をシュレム管内の少なくともある部分に円周方向に挿入する工程を含み得、その結果、上記支持体は、上記管の少なくともある部分の少なくとも部分的な開通性を修復または維持する。上記支持体は、シュレム管の中心コアの少なくともある部分を占めていても占めていなくてもよい。いくつかのバリエーションにおいて、上記支持体は、シュレム管を横切る、経壁の、もしくは経管の流れ、および/または上記管に沿った長手方向の流れを実質的に妨げ得ない。
任意の適切な方法が、本明細書中に記載されるデバイスを作製するために使用され得る。例えば、いくつかのバリエーションにおいて、支持体は、基材をねじることによって形成され得る(例えば、リボン部材)。上記基材は、例えば、マンドレルを取り巻いてねじられ得る。いくつかの場合において、上記基材の一方の末端は、道具(例えば、万力)によって保持され得るが、上記基材の他方の末端は、上記基材をねじるために回転する別の道具(例えば、同様の万力)によって保持されるか、またはつかまれる。本明細書中に記載されるデバイスを形成するために使用され得る方法の他の非限定的な例としては、レーザーエッチング、リソグラフィー、および射出成形が挙げられる。例として、いくつかのバリエーションにおいて、支持体は、リソグラフィー金属析出プロセス(lithography metal deposition process)を用いて作り出され得る。別の例として、特定のバリエーションにおいて、支持体は、ポリマーを前もって造られた型に射出することによって形成され得る。
Claims (13)
- 眼内圧を低減するためのデバイスであって、該デバイスは:
シュレム管内の少なくともある部分において円周方向に移植可能であって、シュレム管の少なくともある部分の少なくとも部分的な開通性を修復または維持するように配置される、ねじられたリボン部材を含み、
ここで該ねじられたリボン部材は、二重螺旋として配列された第一の細長いエッジおよび第二の細長いエッジを含み、そして、該第一の細長いエッジと該第二の細長いエッジとの間に複数の支柱を含み、該複数の支柱ならびに該第一および該第二の細長いエッジは、複数の穴を画定し、該複数の支柱は、長手方向の中央軸に対して実質的に垂直な方向で伸長しており、該中央軸は、少なくとも、所定の長さのセクション内に画定可能であり、
ここで該第一および第二の細長いエッジは、該デバイスがシュレム管に移植されるときにシュレム管の内側表面と連続して接触するように配置される、デバイス。 - 請求項1に記載のデバイスであって、ここで該デバイスがシュレム管に移植されるときに、該デバイスは、シュレム管を横切る経壁の流れを実質的に妨げない、デバイス。
- 前記ねじられたリボン部材が形状記憶合金を含む、請求項1に記載のデバイス。
- 前記形状記憶合金がニッケル−チタン合金を含む、請求項3に記載のデバイス。
- 前記ねじられたリボン部材が金属合金を含む、請求項1に記載のデバイス。
- 前記金属合金がステンレス鋼を含む、請求項5に記載のデバイス。
- 前記ねじられたリボン部材が金属を含む、請求項1に記載のデバイス。
- 前記金属がチタンを含む、請求項7に記載のデバイス。
- 眼内圧を低減するためのキットであって、該キットは、以下:
請求項1〜8に記載のデバイスのいずれか一つ;および
該デバイスをシュレム管内に送達するように構成される導入器
を含む、キット。 - 前記導入器がカニューレを含む、請求項9に記載のキット。
- 前記導入器が、押し出し部材をさらに含む、請求項10に記載のキット。
- 前記ねじられたリボン部材が、該ねじられたリボン部材の長さの0.5ミリメートルから2ミリメートル毎について全360°の回転を完了する、請求項1に記載のデバイス。
- 前記複数の穴の各々は、幅および長さを有し、分離距離で隣の穴から分離されており、該幅は1ミクロン〜600ミクロンの間であり、該長さは1ミクロン〜5000ミクロンの間であり、該分離距離は1ミクロン〜5000ミクロンの間である、請求項1に記載のデバイス。
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US20120059461A1 (en) | 2012-03-08 |
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WO2011097408A1 (en) | 2011-08-11 |
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US8529622B2 (en) | 2013-09-10 |
EP2531138B1 (en) | 2016-11-30 |
JP2015091431A (ja) | 2015-05-14 |
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