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RU2018142990A - Внутриглазная доставка лекарственных препаратов - Google Patents

Внутриглазная доставка лекарственных препаратов Download PDF

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RU2018142990A
RU2018142990A RU2018142990A RU2018142990A RU2018142990A RU 2018142990 A RU2018142990 A RU 2018142990A RU 2018142990 A RU2018142990 A RU 2018142990A RU 2018142990 A RU2018142990 A RU 2018142990A RU 2018142990 A RU2018142990 A RU 2018142990A
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implant
eye
needle
sclera
anterior chamber
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RU2018142990A
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RU2018142990A3 (ru
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Кристофер ХОРВАТ
Ласло О. РОМОДА
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Эквисис, Инк.
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Publication of RU2018142990A3 publication Critical patent/RU2018142990A3/ru
Publication of RU2018142990A publication Critical patent/RU2018142990A/ru

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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
    • 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
    • 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
    • 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
    • A61F9/00736—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A61K9/0051—Ocular inserts, ocular implants
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/222—Gelatin
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into 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
    • 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
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/602—Type of release, e.g. controlled, sustained, slow
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/16—Materials or treatment for tissue regeneration for reconstruction of eye parts, e.g. intraocular lens, cornea

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Surgery (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)
  • Medicinal Preparation (AREA)

Claims (35)

1. Способ размещения интраокулярного имплантата, имеющего удлиненное тело с первым концом и вторым концом, расположенным противоположно первому концу, внутри глаза с подходом снаружи, включающий этапы:
продвижения иглы, в которую помещен имплантат, в глаз путем прокалывания конъюнктивы, теноновой капсулы и склеры глаза и перемещения иглы через конъюнктиву, тенонову капсулу и склеру глаза, причем имплантат содержит лекарственный препарат, выполненный с возможностью доставки в глаз; и
высвобождения интраокулярного имплантата для закрепления имплантата внутри интрасклерального пространства глаза.
2. Способ по п. 1, в котором при высвобождении второй конец имплантата, который является проксимальным концом имплантата, расположен внутри склеры.
3. Способ по п. 1, в котором имплантат имеет первую часть вблизи первого конца и вторую часть вблизи второго конца, при этом высвобождение включает расположение первой части имплантата внутри передней камеры глаза, а второй части имплантата - внутри интрасклерального пространства.
4. Способ по п. 1, в котором имплантат имеет первую часть вблизи первого конца и вторую часть вблизи второго конца, при этом продвижение иглы дополнительно включает продвижение штока толкателя внутри иглы для расположения имплантата на дистальной концевой части иглы.
5. Способ по п. 4, включающий расположение среза иглы внутри передней камеры глаза при одновременном продвижении штока толкателя для продвижения первой части имплантата через срез иглы, позволяя при этом второй части имплантата оставаться внутри иглы.
6. Способ по п. 5, дополнительно включающий втягивание иглы относительно штока толкателя, сохраняя при этом шток толкателя неподвижным относительно глаза для удержания первой части имплантата внутри передней камеры глаза.
7. Способ по п. 1, включающий расположение среза иглы внутри передней камеры глаза.
8. Способ по п. 7, в котором имплантат имеет первую часть вблизи первого конца и вторую часть вблизи второго конца, при этом расположение включает ориентирование продольной оси иглы под углом относительно зрительной оси глаза для упрощения размещения второй части имплантата вглубь относительно поверхностного слоя склеры и размещения первой части имплантата внутри передней камеры глаза.
9. Способ по п. 8, в котором угол находится в диапазоне от приблизительно 10 градусов до приблизительно 60 градусов.
10. Способ по п. 8, в котором угол находится в диапазоне от приблизительно 20 градусов до приблизительно 50 градусов.
11. Способ по п. 8, в котором угол находится в диапазоне от приблизительно 25 градусов до приблизительно 40 градусов.
12. Способ по п. 8, в котором угол находится в диапазоне от приблизительно 30 градусов до приблизительно 35 градусов.
13. Способ по п. 8, в котором угол составляет приблизительно 30 градусов.
14. Способ по п. 1, в котором при высвобождении первый конец имплантата располагают внутри передней камеры глаза, а второй конец имплантата располагают по меньшей мере приблизительно на 0,25-0,5 мм вглубь относительно поверхностной стенки склеры.
15. Способ по п. 1, в котором при высвобождении второй конец имплантата, который является проксимальным концом имплантата, располагают по меньшей мере приблизительно на 0,25-0,5 мм вглубь относительно поверхностной стенки склеры.
16. Способ по п. 1, в котором при высвобождении первый конец имплантата располагают внутри передней камеры, а второй конец имплантата располагают по меньшей мере приблизительно на 0,5-0,75 мм вглубь относительно поверхностной стенки склеры.
17. Способ по п. 1, в котором при высвобождении второй конец имплантата, который является проксимальным концом имплантата, располагают по меньшей мере приблизительно на 0,5-0,75 мм вглубь относительно поверхностной стенки склеры.
18. Способ по п. 1, дополнительно включающий этап приведения связанной с иглой гильзы в контакт с внешней поверхностью глаза для ограничения дополнительного продольного продвижения иглы в глаз.
19. Способ по п. 1, в котором имплантат имеет первую часть вблизи первого конца и вторую часть вблизи второго конца, при этом высвобождение включает высвобождение интраокулярного имплантата для закрепления первой части имплантата вглубь относительно склеры, а второй части имплантата - внутри интрасклерального пространства глаза.
20. Способ по п. 19, в котором высвобождение включает расположение второй части имплантата между слоями склеры.
21. Способ по п. 1, в котором имплантат содержит выходную часть вблизи первого конца, при этом способ включает расположение среза иглы внутри передней камеры глаза и выходной части имплантата внутри передней камеры.
22. Способ по п. 1, в котором имплантат содержит выходную часть вблизи первого конца, при этом способ включает расположение среза иглы внутри хориоидального пространства глаза и выходной части имплантата - внутри хориоидального пространства.
23. Способ по п. 1, в котором имплантат содержит выходную часть вблизи первого конца, при этом способ включает расположение среза иглы внутри пространства стекловидного тела глаза и выходной части имплантата внутри пространства стекловидного тела.
24. Способ по п. 1, в котором имплантат имеет первую часть вблизи первого конца и вторую часть вблизи второго конца, при этом имплантат имеет суженный профиль в поперечном сечении, причем вторая часть имеет профиль большего размера в поперечном сечении по сравнению с меньшим профилем в поперечном сечении первой части, при этом высвобождение включает закрепление имплантата путем расположения второй части имплантата с профилем большего размера в поперечном сечении поверхностно внутри склеры, а первой части с профилем меньшего размера в поперечном сечении - вглубь относительно второй части.
25. Способ по п. 24, в котором имплантат имеет коническую форму, причем первая концевая часть имплантата имеет больший профиль в поперечном сечении по сравнению со второй концевой частью.
26. Способ по п. 1, в котором имплантат имеет первую часть вблизи первого конца и вторую часть вблизи второго конца, при этом имплантат имеет по меньшей мере один фиксирующий выступ, размещенный вдоль внешней области второй части имплантата, которая является проксимальной частью имплантата, причем высвобождение включает закрепление имплантата путем расположения фиксирующего выступа между слоями склеры.
27. Способ по п. 26, в котором по меньшей мере один фиксирующий выступ представляет собой крючок, ребро, шип, зубец, крылышко или выпуклость.
28. Способ по п. 1, в котором имплантат представляет собой интраокулярный шунт.
29. Способ по п. 1, в котором первый конец имплантата является дистальным концом, а второй конец имплантата – проксимальным концом, при этом способ дополнительно включает расположение проксимального конца имплантата внутри целевой области вывода текучей среды, а дистального конца имплантата - внутри передней камеры глаза.
30. Способ по п. 29, в котором имплантат представляет собой интраокулярный шунт, при этом лекарственный препарат покрывает шунт или заполняет просвет шунта.
31. Способ по п. 1, в котором имплантат содержит мягкий биосовместимый материал.
32. Способ по п. 31, в котором имплантат содержит мягкий полимерный материал.
33. Способ по п. 31, в котором имплантат содержит желатиновый материал.
RU2018142990A 2016-06-02 2017-06-02 Внутриглазная доставка лекарственных препаратов RU2018142990A (ru)

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US201662344899P 2016-06-02 2016-06-02
US62/344,899 2016-06-02
PCT/US2017/035802 WO2017210627A1 (en) 2016-06-02 2017-06-02 Intraocular drug delivery

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RU2018142990A3 RU2018142990A3 (ru) 2020-06-05
RU2018142990A true RU2018142990A (ru) 2020-06-05

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US (3) US10667947B2 (ru)
EP (1) EP3463228A4 (ru)
JP (1) JP2019517366A (ru)
KR (1) KR20190019966A (ru)
CN (1) CN109561987A (ru)
AU (1) AU2017274654A1 (ru)
BR (1) BR112018074389A2 (ru)
CA (1) CA3025526A1 (ru)
MX (1) MX2018014763A (ru)
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WO (1) WO2017210627A1 (ru)

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US11058581B2 (en) 2017-07-20 2021-07-13 Shifamed Holdings, Llc Adjustable flow glaucoma shunts and methods for making and using same
US11166849B2 (en) 2017-07-20 2021-11-09 Shifamed Holdings, Llc Adjustable flow glaucoma shunts and methods for making and using same
US11291585B2 (en) 2020-02-14 2022-04-05 Shifamed Holdings, Llc Shunting systems with rotation-based flow control assemblies, and associated systems and methods
US11517477B2 (en) 2019-10-10 2022-12-06 Shifamed Holdings, Llc Adjustable flow glaucoma shunts and associated systems and methods
US11529258B2 (en) 2020-01-23 2022-12-20 Shifamed Holdings, Llc Adjustable flow glaucoma shunts and associated systems and methods
US11596550B2 (en) 2020-04-16 2023-03-07 Shifamed Holdings, Llc Adjustable glaucoma treatment devices and associated systems and methods
US11737920B2 (en) 2020-02-18 2023-08-29 Shifamed Holdings, Llc Adjustable flow glaucoma shunts having non-linearly arranged flow control elements, and associated systems and methods
US11766355B2 (en) 2020-03-19 2023-09-26 Shifamed Holdings, Llc Intraocular shunts with low-profile actuation elements and associated systems and methods
US11865283B2 (en) 2021-01-22 2024-01-09 Shifamed Holdings, Llc Adjustable shunting systems with plate assemblies, and associated systems and methods
US12329682B2 (en) 2019-01-18 2025-06-17 Shifamed Holdings, Llc Adjustable flow glaucoma shunts and methods for making and using same

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US20120123316A1 (en) 2010-11-15 2012-05-17 Aquesys, Inc. Intraocular shunts for placement in the intra-tenon's space
US10085884B2 (en) 2006-06-30 2018-10-02 Aquesys, Inc. Intraocular devices
US8852256B2 (en) 2010-11-15 2014-10-07 Aquesys, Inc. Methods for intraocular shunt placement
US8721702B2 (en) 2010-11-15 2014-05-13 Aquesys, Inc. Intraocular shunt deployment devices
US8968396B2 (en) 2007-07-23 2015-03-03 Powervision, Inc. Intraocular lens delivery systems and methods of use
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US20170348150A1 (en) 2017-12-07
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EP3463228A1 (en) 2019-04-10
US20250009557A1 (en) 2025-01-09
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CA3025526A1 (en) 2017-12-07
WO2017210627A1 (en) 2017-12-07

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