JP6465490B2 - インプラント送達装置 - Google Patents
インプラント送達装置 Download PDFInfo
- Publication number
- JP6465490B2 JP6465490B2 JP2015503312A JP2015503312A JP6465490B2 JP 6465490 B2 JP6465490 B2 JP 6465490B2 JP 2015503312 A JP2015503312 A JP 2015503312A JP 2015503312 A JP2015503312 A JP 2015503312A JP 6465490 B2 JP6465490 B2 JP 6465490B2
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- Prior art keywords
- implant
- delivery device
- implant delivery
- cam
- collet
- 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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- VBEQCZHXXJYVRD-GACYYNSASA-N uroanthelone Chemical compound C([C@@H](C(=O)N[C@H](C(=O)N[C@@H](CS)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CS)C(=O)N[C@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)NCC(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CS)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(O)=O)C(C)C)[C@@H](C)O)NC(=O)[C@H](CO)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@@H](NC(=O)[C@H](CC=1NC=NC=1)NC(=O)[C@H](CCSC)NC(=O)[C@H](CS)NC(=O)[C@@H](NC(=O)CNC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CS)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)CNC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@H]1N(CCC1)C(=O)[C@H](CS)NC(=O)CNC(=O)[C@H]1N(CCC1)C(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@@H](N)CC(N)=O)C(C)C)[C@@H](C)CC)C1=CC=C(O)C=C1 VBEQCZHXXJYVRD-GACYYNSASA-N 0.000 description 1
- 229960005356 urokinase Drugs 0.000 description 1
- 229960005486 vaccine Drugs 0.000 description 1
- 229940093257 valacyclovir Drugs 0.000 description 1
- 229960002004 valdecoxib Drugs 0.000 description 1
- LNPDTQAFDNKSHK-UHFFFAOYSA-N valdecoxib Chemical compound CC=1ON=C(C=2C=CC=CC=2)C=1C1=CC=C(S(N)(=O)=O)C=C1 LNPDTQAFDNKSHK-UHFFFAOYSA-N 0.000 description 1
- 229960002149 valganciclovir Drugs 0.000 description 1
- 229960003165 vancomycin Drugs 0.000 description 1
- MYPYJXKWCTUITO-LYRMYLQWSA-N vancomycin Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1OC1=C2C=C3C=C1OC1=CC=C(C=C1Cl)[C@@H](O)[C@H](C(N[C@@H](CC(N)=O)C(=O)N[C@H]3C(=O)N[C@H]1C(=O)N[C@H](C(N[C@@H](C3=CC(O)=CC(O)=C3C=3C(O)=CC=C1C=3)C(O)=O)=O)[C@H](O)C1=CC=C(C(=C1)Cl)O2)=O)NC(=O)[C@@H](CC(C)C)NC)[C@H]1C[C@](C)(N)[C@H](O)[C@H](C)O1 MYPYJXKWCTUITO-LYRMYLQWSA-N 0.000 description 1
- MYPYJXKWCTUITO-UHFFFAOYSA-N vancomycin Natural products O1C(C(=C2)Cl)=CC=C2C(O)C(C(NC(C2=CC(O)=CC(O)=C2C=2C(O)=CC=C3C=2)C(O)=O)=O)NC(=O)C3NC(=O)C2NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(CC(C)C)NC)C(O)C(C=C3Cl)=CC=C3OC3=CC2=CC1=C3OC1OC(CO)C(O)C(O)C1OC1CC(C)(N)C(O)C(C)O1 MYPYJXKWCTUITO-UHFFFAOYSA-N 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
- 229960003726 vasopressin Drugs 0.000 description 1
- 229960001722 verapamil Drugs 0.000 description 1
- 229960003895 verteporfin Drugs 0.000 description 1
- ZQFGRJWRSLZCSQ-ZSFNYQMMSA-N verteporfin Chemical compound C=1C([C@@]2([C@H](C(=O)OC)C(=CC=C22)C(=O)OC)C)=NC2=CC(C(=C2C=C)C)=NC2=CC(C(=C2CCC(O)=O)C)=NC2=CC2=NC=1C(C)=C2CCC(=O)OC ZQFGRJWRSLZCSQ-ZSFNYQMMSA-N 0.000 description 1
- 229960003636 vidarabine Drugs 0.000 description 1
- 229960003048 vinblastine Drugs 0.000 description 1
- JXLYSJRDGCGARV-XQKSVPLYSA-N vincaleukoblastine Chemical compound C([C@@H](C[C@]1(C(=O)OC)C=2C(=CC3=C([C@]45[C@H]([C@@]([C@H](OC(C)=O)[C@]6(CC)C=CCN([C@H]56)CC4)(O)C(=O)OC)N3C)C=2)OC)C[C@@](C2)(O)CC)N2CCC2=C1NC1=CC=CC=C21 JXLYSJRDGCGARV-XQKSVPLYSA-N 0.000 description 1
- OGWKCGZFUXNPDA-XQKSVPLYSA-N vincristine Chemical compound C([N@]1C[C@@H](C[C@]2(C(=O)OC)C=3C(=CC4=C([C@]56[C@H]([C@@]([C@H](OC(C)=O)[C@]7(CC)C=CCN([C@H]67)CC5)(O)C(=O)OC)N4C=O)C=3)OC)C[C@@](C1)(O)CC)CC1=C2NC2=CC=CC=C12 OGWKCGZFUXNPDA-XQKSVPLYSA-N 0.000 description 1
- 229960004528 vincristine Drugs 0.000 description 1
- OGWKCGZFUXNPDA-UHFFFAOYSA-N vincristine Natural products C1C(CC)(O)CC(CC2(C(=O)OC)C=3C(=CC4=C(C56C(C(C(OC(C)=O)C7(CC)C=CCN(C67)CC5)(O)C(=O)OC)N4C=O)C=3)OC)CN1CCC1=C2NC2=CC=CC=C12 OGWKCGZFUXNPDA-UHFFFAOYSA-N 0.000 description 1
- 238000012800 visualization Methods 0.000 description 1
- 235000019165 vitamin E Nutrition 0.000 description 1
- 229940046009 vitamin E Drugs 0.000 description 1
- 239000011709 vitamin E Substances 0.000 description 1
- 229960004740 voriconazole Drugs 0.000 description 1
- BCEHBSKCWLPMDN-MGPLVRAMSA-N voriconazole Chemical compound C1([C@H](C)[C@](O)(CN2N=CN=C2)C=2C(=CC(F)=CC=2)F)=NC=NC=C1F BCEHBSKCWLPMDN-MGPLVRAMSA-N 0.000 description 1
- 229960005080 warfarin Drugs 0.000 description 1
- PJVWKTKQMONHTI-UHFFFAOYSA-N warfarin Chemical compound OC=1C2=CC=CC=C2OC(=O)C=1C(CC(=O)C)C1=CC=CC=C1 PJVWKTKQMONHTI-UHFFFAOYSA-N 0.000 description 1
- 238000004804 winding Methods 0.000 description 1
- 229960001522 ximelagatran Drugs 0.000 description 1
- ZXIBCJHYVWYIKI-PZJWPPBQSA-N ximelagatran Chemical compound C1([C@@H](NCC(=O)OCC)C(=O)N2[C@@H](CC2)C(=O)NCC=2C=CC(=CC=2)C(\N)=N\O)CCCCC1 ZXIBCJHYVWYIKI-PZJWPPBQSA-N 0.000 description 1
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
- 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
- A61F9/007—Methods or devices for eye surgery
- A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment
-
- 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
-
- 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
- A61F2/148—Implantation instruments specially adapted therefor
-
- 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
- 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
- A61F2250/009—Additional features; Implant or prostheses properties not otherwise provided for for single use, e.g. having means for preventing re-use
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04C—ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS
- F04C2270/00—Control; Monitoring or safety arrangements
- F04C2270/04—Force
- F04C2270/042—Force radial
- F04C2270/0421—Controlled or regulated
Landscapes
- Health & Medical Sciences (AREA)
- Ophthalmology & Optometry (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Cardiology (AREA)
- Transplantation (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Surgery (AREA)
- Prostheses (AREA)
Description
されたエネルギ源であって、コレットの遠位端がインプラントのうちの対応する1つをトロカールに沿って眼組織内へ前進させるようにエネルギを放出するように構成されたエネルギ源を含む。このとき、トロカールの遠位端と、コレットの遠位端との間の距離は、インプラント送達サイクル間で増加することができる。一部の実施形態では、トロカールの遠位端と、コレットの遠位端との間の距離は、インプラント送達サイクル間で同じままである。
125まで達する。
トの右側及び左側への言及を含む。「遠位」及び「近位」という用語は、当業者にとって普通の習慣的意味を与えられる(特殊な又は特別な意味に限定されない)とされ、特定の構造の、相対する両領域又は両端を制限なしに意味する。一部の実施形態では、「遠位」という用語は、本明細書で説明されるシステム及び装置を使用している又は本明細書で説明される方法を実施している人物から遠く離れたほうの領域又は端を意味するために使用され、「近位」という用語は、本明細書で説明されるシステム及び装置を使用している又は本明細書で説明される方法を実施している人物に近いほうの領域又は端を言うために使用される。ただし、これらの用語の意味は、入れ替え可能である。
図3は、複数インプラント送達装置200の分解斜視図である。複数インプラント送達装置200の外部コンポーネントは、左側ケース302と、右側ケース304と、左側締め具305Aと、右側締め具305Bと、ラベル板210とを含む。図に示されるように、外側ケース202は、2つの個別の片側部分品(左側ケース302及び右側ケース304)で形成される。組み立てられたときに、左側ケース302の近位端及び右側ケース304の近位端は、左側締め具305A及び右側締め具305Bによって留め合わされる。図に描かれた実施形態では、左側締め具305Aは、六角形ナットであり、右側締め具305Bは、六角穴付きネジである。しかしながら、所望及び/又は所要に応じてその他の形状及びタイプの締め具が使用可能である。左側ケース302及び右側ケース304の中間及び遠位端は、一実施形態では、左側ケース302及び右側ケース304のそれぞれに配されたスナップ式部材308A、308Bによってスナップ式に嵌め合わされるように構成することができる。図に描かれた実施形態は、締め具305A、305B及びスナップ式部材308A、308Bを示しているが、例えば、糊付け、溶接、融着、Velcro、及び接着剤による接合などの、2つの片側部分品を留め合わせるその他の方法も考えられる。また、代替の実施形態では、外側ケース202は、右側及び左側の片側部分品の代わりに、上側及び底側の片側部分品に分けられることがある。更に別の代替の実施形態では、外側ケース202は、合体させて連続した一体品を形成するように構成された3つ以上の部分品で形成される。
ンアセンブリ(トリガユニット351、トリガバネ352、及びトリガ合わせピン353を含む)と、を含む。
グは、針208の内表面ではなく(切開用の特徴を含む)外表面に塗布される。一部の実施形態では、針208は、外側の眼組織に切開を形成するように構成された、カニューレや外科用メスなどの、任意の適切な穿孔部材で置き換えられる。
a(登録商標)LCPを成形して形成されるが、しかしながら、所望に応じてその他のポリマ材料(例えば、ネオプレン、ナイロン、ポリ塩化ビニル(PCV)、ポリスチレン、ポリエチレン、ポリプロピレン、ポリアクリロニトリル、シリコーン、ポリビニル・ブチラール(PVB)、ポリアクリロニトリル・ブタジエン・スチレン(ABS))を使用することも可能である。
及び補助チューブ816は、その他の金属、プラスチック、又はポリマなどの、その他の適切な材料で構成することができる。
ピンスロット356と、トリガボタン延長部357と、トリガ開口358とを含む。トリガボタン216は、ユーザの指で押せるようにサイズ及び形状を決定される。特定の実施形態では、トリガボタン216は、ユーザが更にしっかり把持する又は感触を得ることができるように、触知可能な隆起又は溝を含む。
を実現する。カム341の操作、及びコレット322の横移動に対するその作用は、図16A〜16E及び図17との関連のもとで後ほど論じられる。幾つかの実施形態にしたがうと、インプラントは、眼組織内における、複数インプラント送達装置200の遠位端から特定の距離において実質的に同じ深さにインプラントされるように構成され、この深さは、本明細書で説明されるカム341の構造的特徴、又はその他の特徴若しくは機構によって制御されてよい。
図14A及び図14Bは、複数インプラント送達装置200の組み立てを示しており、組み立ての際に右側ケース304内に配されるときに、全ての内部コンポーネントが互い
にどのように相互作用するかを示している。なお、複数インプラント送達装置200の組み立てには、多くの組立方法が使用可能であることが、認識されるべきである。組み立て方法の一実施形態は、以下のとおりである。
複数インプラント送達装置の操作
達装置200の挿入を示している。インプラント送達の一実施形態では、患者は、前準備を経てドレープをかけられ、麻酔を投入されて仰臥位の状態にある。一実施形態では、眼の角膜輪部若しくはその他の外表面領域に、又はその近くに、自ら閉じる小さな(例えば1mm未満の)切開又は開口が形成される。特定の実施形態では、針208は、所望のインプラント部位から眼球を挟んで反対側の部位から挿入される。針208は、次いで、隅角鏡(レンズ)又は内視鏡による誘導のもとで、角膜切開に通されて小柱網121内の所望のインプラント部位に向かって前眼房120を突っ切るように前進される。図15は、ab interno挿入方法を示しているが、ab externo挿入方法も考えられることが認識されるべきである。
へ前進されている。例示の実施形態では、インプラント901は、トロカール814の長手方向軸に沿って縦一列に配置されている。各インプラント901は、トロカール814の少なくとも一部分が通る内腔を含む。コレット322の遠位端の最初の開始地点は、第1のインプラント901Aの前端部に対応しており、トロカール814の遠位端から離れていることが可能である。
じ眼内の、第2のインプラント901Bの送達のための第2の所望のインプラント部位へ移動させることができる。したがって、複数インプラント送達装置200は、別のインプラントを再装填するために眼から針208又はトロカール814を取り出す必要なく眼内の複数の場所に複数の眼インプラントを有利に送達することができる。
することを防ぐのにも役立つことができる。漏出を防ぐための適切なシールは、例えば、Oリング、コーティング、親水性物質、疎水性物質、及びそれらの組み合わせを含む。コーティングは、例えば、MDC(商標)シリコーン流体などの、シリコーンコーティングであってよい。一部の実施形態では、複数インプラント送達装置200は、コーティングと、親水性又は疎水性の物質とでコーティングされる。一部の実施形態では、装置の一領域が、コーティングに親水性物質を加えたものでコーティングされ、装置の別の領域が、コーティングに疎水性物質を加えたものでコーティングされる。シールは、装置の部材の滑り嵌め表面間に疎水性コーティング又は親水性コーティングを含むことができる。シールは、複数インプラント送達装置200によって運ばれるときのインプラントのごく近くに配することができる。幾つかの実施形態にしたがうと、シールは、互いにぴったり合うように機械加工された2つの機器のそれぞれの少なくとも一区域上にあることが有利である。様々な実施形態では、シールは、少なくとも、挿入チューブ1902の内表面上、コレット322の外表面上、又はそれらの両表面上にある。
インプラント
て、インプラントの寸法、特徴、先端の構成、材料の可塑性、コーティング、弁の設計などの様々な例が、以下で詳細に論じられる。本明細書では、眼インプラントが説明されるが、本明細書で説明されるシステム及び方法の実施形態によって、その他の体内組織又は体腔にインプラントするためのその他のタイプのインプラントも使用可能であることが、理解されるべきである。「インプラント」という用語は、様々な実施形態では、「ステント」又は「シャント」という用語で置き換え可能である。
がる平坦な環状表面を含むことができる。遠位部分907の近位端における断面測定値は、約0.05mmから約0.5mmまで(例えば約0.2mm)であってよい。遠位部分907の側面は、遠位部分907の近位端から円錐と同様に先細る構成で遠位側へ伸びている。遠位部分907の側面は、インプラント901を貫通している内腔と交わる遠位端に到達して終結するまで先細り、したがって、平坦な遠位端を有する円錐台形を形成している。遠位部分907の側面は、円錐台形状の遠位部分907に沿って円周方向に位置決めされた開口又は孔(例えば、排出ポート906)を含むことができ、該開口又は孔は、遠位部分907の外側と、インプラント901を貫通している内腔908との間で流体を連通させる。遠位部分907の遠位端の表面は、遠位部分907の内腔と軸方向に揃えられた出口又は孔(不図示)を含むことができる。インプラント901の遠位部分907を貫通する内腔は、近位部分及び中間部分の両方を貫通する内腔と軸方向に揃えられていることが好ましい。
ようにサイズ決定及び構成されてよい。一部の実施形態では、流出部分は、シュレム管内にあるようにサイズ決定及び構成されてよい。その他の実施形態では、流出部分は、少なくとも部分的に、ブドウ膜強膜流出経路の上毛様体領域内に又は上脈絡膜空間内にあるようにサイズ決定及び構成されてよい。
の周囲に戻ることができる。もし、環の幅が十分に小さく場合は、遠位部分は、眼組織を広げるのではなく押圧する可能性があるだろう。
にするために、側面上に1つの出口開口を有する。一部の実施形態では、キャップは、流体の流れを可能にするために、側面上に複数の出口開口を有する。その他の実施形態では、キャップの円錐状表面上に、複数の出口開口がある。キャップ上の開口は、インプラントを通る流体の流れを促すことができる。開口は、流体が流れるための代替ルートを提供しえて、これは、インプラントの主要な流出部分が遮断された場合に有益である。
なる群より選択することができる。薬剤溶出コーティングに使用されえる材料には、パリレンC、ポリ(ブチルメタクリラート)、ポリ(メチルメタクリラート)、ポリエチレン−co−ビニルアセテート、及びその他の材料がある。
する。拡張された流路は、インプラントの長さを長くしなくても、インプラントを流れる流体に対し、より大きな潜在的流動抵抗を提供する。芯は、1本のらせん流路を有していることがある、又はインプラント内を流体が流れえる複数の流路を提供するために複数のらせん流路を有していることがある。例えば、芯は、交差することができる2本以上のらせん流路を有することができる。
く、成長を促すために、インプラントの近位端に成長促進剤が塗布されていてよい。
テリシンB及びミコナゾールなどの、抗真菌薬と、イドクスウリジン・トリフルオロチミジン、アシクロビル、ガンシクロビル、インターフェロンなどの、抗ウィルス薬と、抗有糸分裂薬と、例えばクロモグリク酸ナトリウム、アンタゾリン、メタピリリン、クロルフェニラミン、セトリジン、ピリラミン、プロフェンピリダミンを含む、抗アレルギ薬などの、免疫調整薬と、アゼラスチン、エメダスチン、及びレボカバスチンなどの、抗ヒスタミン剤と、(ワクチン及び免疫刺激薬などの、)免疫薬と、クロモリン酸ナトリウム、ケトチフェン、ロドキサミド、ネドクリミル、及びオロパタジンなどの、肥満細胞安定剤、並びにゲンチミシン、及びシドフォビルなどの、ペリモラスト毛様体切除剤と、ベルテポルフィン、プロパラカイン、テトラカイン、シクロスポリン、及びポリカルピンなどの、その他の眼科用剤と、細胞表面糖タンパク質受容体の阻害物質と、フェニレフリン、ナファゾリン、テトラヒドラゾリンなどの、うっ血除去薬と、脂質又は降圧脂質と、キンピロール、フェノルドパム、イボパミンなどの、ドパーミン受容体刺激薬及び/又は拮抗薬と、血管れん縮阻害物質と、血管拡張薬と、抗高血圧薬と、アンジオテンシン変換酵素(ACE)阻害物質と、オルメサルタンなどの、アンジオテンシン−1受容体拮抗薬と、微小管阻害物質と、分子モータ(ダイニン及び/又はキネシン)阻害物質と、サイトカラシン、ラトランキュリン、スウィンホリドA、エタクリン酸、H−7、及びRhoキナーゼ(ROCK)阻害物質などの、アクチン細胞骨格制御剤と、リモデリング阻害物質と、tert−ブチルヒドロキノロン、及びAL−3037Aなどの、細胞外基質の調節物質と、N−6−シクロヘキシルアデノシン、及び(R)−フェニルイソプロピルアデノシンなどの、アデノシン受容体作動薬及び/又は拮抗薬と、セロトニン作動薬と、エストロゲン、エストラジオール、月経前期ホルモン、黄体ホルモン、インシュリン、カルシトニン、副甲状腺ホルモン、ペプチド及びバソプレシン視床下部放出因子などの、ホルモン剤と、例えば上皮増殖因子、繊維芽細胞増殖因子、血小板由来性増殖因子又はその拮抗薬(それぞれ参照によってその全体を本明細書に組み込まれた米国特許第7,759,472号、又は米国特許出願第12/465,051号、第12/564,863号、若しくは第12/641,270号に開示されるものなど)、形質転換増殖因子ベータ、成長ホルモン、フィブロネクチン、結合組織増殖因子、骨形成タンパク質(BMP)を含む、増殖因子拮抗薬又は増殖因子と、インターロイキン、CD44、cochlin、血清アミロイドAなどの血清アミロイドなどの、サイトカインと、も挙げられる。
、キナーゼ阻害物質又は修飾物質と、ベータ1−インテグリン活性化抗体HUT−21などの、インテグリン機能に作用を及ぼす化合物又は因子と、N−アクリル−エタノールアミン及びそれらの前駆体、N−アクリル−エタノールアミンリン脂質と、グルカゴン様ペプチド−1受容体の刺激物質(例えばグルカゴン様ペプチド−1)と、レスベラトロールなどの、ポリフェノール含有化合物と、キレート化化合物と、アポトーシス関連プロテアーゼ阻害物質と、新しいタンパク質の合成を抑制する化合物と、放射線治療薬と、光線力学治療薬と、遺伝子治療薬と、遺伝子修飾物質と、グラチマーなどの、神経又は神経の部分に対する損傷(例えば脱髄)を阻止する自己免疫調節物質と、抗NgR遮断タンパク質、NgR(310)ecto−Fcなどの、ミエリン阻害物質と、FK506結合タンパク質(例えばFKBP51)などの、その他の免疫調節物質と、シクロスポリンA、粘滑薬、及びヒアルロン酸ナトリウムなどの、ドライアイ用薬物と、が挙げられる。
ド類と、アモキシシリン、アンピシリン、ピバンピシリン、ジクロキサシリン、ナフシリン、オキサシリン、ピペラシリン、及びチカルシリンを含む、(クラブラン酸を伴う及び伴わない)ペニシリン類と、ドキシサイクリン、ミノサイクリン、及びテトラサイクリンなどの、テトラサイクリン類と、アズトレオナム、クロラムフェニコール、クリンダマイシン、リネゾリド、ニトロフラントイン、及びバンコマイシンなどの、その他の抗菌性物質と、ドキサゾシン、プラゾシン、及びテラゾシンなどの、α遮断剤と、アムロジン、ベプリジル、ジルチアゼム、フェロジピン、イスラジピン、ニカルジピン、ニフェジピン、ニソルジピン、及びベラパミルなどの、カルシウムチャネル遮断物質と、クロニジン、ジアゾキシド、フェルノドパム、ヒドララジン、ミノキシジル、ニトロプルシド、フェノキシベンゼンアミン、エポプロステノール、トラゾリン、トレプロスチニル、及び硝酸塩ベースの剤などの、その他の抗高血圧剤と、ヘパリン、ダルテパリン、エノキサパリン、チンザパリン、フォンダパリヌクスなどの、ヘパリン類及びヘパリン類似物質を含む、抗凝血剤と、ヒルジン、アプロチニン、アルガトロバン、ビバリルジン、デシルジン、レピルジン、ワルファリン、及びキシメラガトランなどの、その他の抗凝血剤と、アブシキシマブ、クロピドグレル、ジピリダモール、エプチフィバチド、チクロピジン、及びチロフィバンなどの、抗血小板剤と、アルプロスタジル、カルボプロスト、シルデナフィル、タダラフィル、ファルデナフィルなどの、プロスタグランジンPDE−5阻害物質及びその他のプロスタグランジン剤と、トロンビン阻害物質と、抗血栓性剤と、血小板凝集抑制剤と、アルテプラーゼ、アニストレプラーゼ、レテプラーゼ、ストレプトキナーゼ、テネクテプラーゼ、ウロキナーゼなどの、血栓溶解剤及び/又は繊維素溶解剤と、シロリムス、タクロリムス、エベロリムス、ゾタロリムス、パクリタキセル、ミコフェノール酸などの、抗増殖剤と、レボチロキシン、フルオキシメストロン、メチルテストステロン、ナンドロロン、オキサンドロロン、テストステロン、エストラジオール、エストロン、エストロピペート、クロミフェン、ゴナドトロピン、ヒドロキシプロゲステロン、レボノルゲストレル、メドロキシプロゲステロン、メゲストロール、ミフェプリストン、ノルエチンドロン、オキシトシン、プロゲステロン、ラロキシフェン、及びタモキシフェンを含む、ホルモン関連剤と、カルムスチン、ロムスチン、メルファラン、シスプラチン、フルオロウラシル3などの、アルキル化剤、及びブレオマイシン、ダウノルビシン、ドキソルビシン、イダルビシン、ミトマイシン、プリカマイシンなどの、プロカルバジン抗生物質様剤を含む、抗悪性腫瘍剤と、(1,3−cis−レチノイン酸、5−フルオロウラシル、タキソール、ラパマイシン、ミトマイシンC、及びシスプラチンなどの、)抗増殖剤と、シタラビン、フルダラビン、ヒドロキシ尿素、メルカプトプリン、及び5−フルオロウラシル(5−FU)などの、代謝拮抗剤と、アルデスロイキン、イマチニブ、リツキシマブ、及びトシツモマブなどの、免疫調節剤と、ドセタキセル、エトポシド、ビンブラスチン、ビンクリスチンなどの、有糸分裂阻害物質と、ストロンチウムー89などの、放射性薬剤と、イリノテカン、トポテカン、及びミトタンなどの、その他の抗悪性腫瘍剤と、が挙げられる。
の一部とされている。また、インプラントは、白内障手術などの、その他の外科的処置と組み合わせて実施されてよい。血栓症の形成又は組織の再狭窄を抑制するために、インプラントは、その全部又は一部分が、好ましくは流路内において例えばヘパリンなどでコーティングされていてよい。
一部の実施形態にしたがって、眼疾患に対処するためのキット(例えば、共通の目的を持つ複数のアイテムからなるシステム又は集合)が提供される。本明細書で使用されるこの「キット」という用語は、その通常の意味を与えられることが望ましく、共通の目標のために提供された複数の機器、システム、コンポーネント、特徴、材料などからなる、任意のシステム、グループ分け、及び/又は集合を含むことが望ましい。一実施形態では、キットは、送達装置(本明細書で説明される複数インプラント送達装置200など)、複数の排出用インプラント(本明細書で説明される排出用インプラントなど)、切開部材、及びセンサ(圧力センサ、眼圧センサ、被分析物センサ、グルコースセンサ、又は眼内への配置のために構成されたその他の任意のセンサ)のうちの、1つ以上を含む。一部の実施形態では、排出用インプラントは、出荷に先立つ製造及び組み立ての際に、送達装置内に又は送達装置上に事前に装填される。その他の実施形態では、排出用インプラントは、事前に装填されない。キットは、更に、特定の処置又は治療プロトコルのためにキットの様々な機器、コンポーネント、及び/又はその他の特徴を使用するための説明書も含むことができる。このような使用説明書は、機器、システム、又はその他のコンポーネントが使用される順番や使用期間などに関する詳細を含むことができる。
よい」という条件用語は、別途明記されない限り、又は使用される文脈のなかで別の意味に理解されない限り、総じて、特定の実施形態が、その他の実施形態には含まれない特定の特徴、要素、及び/又は段階を含むことを伝えていることを意図される。したがって、このような条件用語は、総じて、特徴、要素、及び/若しくは段階が、1つ以上の実施形態において必ず必要であること、又は1つ以上の実施形態が、ユーザによる入力若しくは指示を伴って若しくは伴わずに、これらの特徴、要素、及び/若しくは段階が任意の特定の実施形態に含まれるかどうかを若しくは任意の特定の実施形態で実施されるかどうかを決断するためのロジックを必然的に含むことを示唆することを意図していない。
Claims (14)
- 眼疾患を治療するためのインプラント送達装置であって、
前記インプラント送達装置内に装填された少なくとも2つのインプラントと、
前記少なくとも2つのインプラントのそれぞれを眼組織内へ送達する際にエネルギを選択的に放出するためのエネルギ源と、
前記エネルギ源に可動作式に結合され、インプラント送達サイクル中に各インプラントに送達されるエネルギの量を変動させるように構成された外形密着輪郭を有するカムと、を備え、
前記少なくとも2つのインプラントは、第1のインプラントと、該第1のインプラントの後に眼組織内へ送達される第2のインプラントと、を含み、
前記外形密着輪郭は、前記第1のインプラントに対して、該インプラントの送達サイクル中に第1距離を移動させることで、該インプラントを眼組織内へ送達させる第一部分と、前記第2のインプラントに対して、該インプラントの送達サイクル中に第2距離を移動させることで、該インプラントを眼組織内へ送達させる第二部分とを備え、前記第2距離が前記第1距離よりも長くなるように前記第一部分及び前記第二部分が構成されることで、インプラント送達サイクル中に各インプラントに送達されるエネルギの量が変動する、
インプラント送達装置。 - 請求項1に記載のインプラント送達装置であって、
前記エネルギ源は、貯蔵エネルギ源を含む、インプラント送達装置。 - 請求項1又は請求項2に記載のインプラント送達装置であって、更に、
外側の眼組織に切開を形成するように構成された撤退可能式の穿孔部材を備えるインプラント送達装置。 - 請求項3に記載のインプラント送達装置であって、更に、
前記穿孔部材が撤退されたときに前記インプラントのうちの対応する1つをそれぞれに受け入れるための、少なくとも2つの開口を内側の眼組織に形成するように構成されたトロカールを備えるインプラント送達装置。 - 請求項1ないし4のいずれか一項に記載のインプラント送達装置であって、
前記少なくとも2つのインプラントのそれぞれは、眼の前眼房内に位置決めされるように構成された入口部分と、前記眼の生理的流出経路内に位置決めされるように構成された出口部分とを含む、インプラント送達装置。 - 請求項1ないし5のいずれか一項に記載のインプラント送達装置であって、
使い捨てであるインプラント送達装置。 - 請求項1ないし6のいずれか一項に記載のインプラント送達装置であって、
該インプラント送達装置の再利用を防ぐ安全機構を備えるインプラント送達装置。 - 請求項7に記載のインプラント送達装置であって、
前記安全機構は、前記インプラント送達装置をもし消毒しなおされたら動作不能にする内部コンポーネントを含む、インプラント送達装置。 - 請求項1ないし8のいずれか一項に記載のインプラント送達装置であって、更に、
前記インプラントを前進させるコレットであって、前記カムに可動作式に結合されるコレットを備えるインプラント送達装置。 - 請求項9に記載のインプラント送達装置であって、
前記コレットは、前記カムの前記外形密着輪郭に係合するためのカムフォロアを含むコレットホルダに接続される、インプラント送達装置。 - 請求項10に記載のインプラント送達装置であって、
バネが、前記コレットホルダを前記カムに向かって付勢する、インプラント送達装置。 - 請求項5に記載のインプラント送達装置であって、
前記少なくとも2つのインプラントのそれぞれは、眼の前眼房から小柱網を経てシュレム管内へ房水を排出するための流体流路を提供するようにサイズ及び形状が決定された排出用眼インプラントである、インプラント送達装置。 - 請求項5に記載のインプラント送達装置であって、
前記少なくとも2つのインプラントのそれぞれは、前記入口部分を含む該インプラントの近位端から前記出口部分を含む該インプラントの遠位端まで延在する内腔を含む、インプラント送達装置。 - 請求項13に記載のインプラント送達装置であって、
前記少なくとも2つのインプラントのそれぞれの前記出口部分は、前記内腔と流体連通している複数の出口ポートを含む、インプラント送達装置。
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EP3342380A2 (en) | 2018-07-04 |
US9554940B2 (en) | 2017-01-31 |
CA3098762C (en) | 2023-01-17 |
HK1257538A1 (zh) | 2019-10-25 |
EP2830553A2 (en) | 2015-02-04 |
WO2013148275A2 (en) | 2013-10-03 |
US20160151204A1 (en) | 2016-06-02 |
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WO2013148275A9 (en) | 2014-09-25 |
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