RU2017120291A - Расширяемые устройства доставки лекарственных средств и способы использования - Google Patents
Расширяемые устройства доставки лекарственных средств и способы использования Download PDFInfo
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- RU2017120291A RU2017120291A RU2017120291A RU2017120291A RU2017120291A RU 2017120291 A RU2017120291 A RU 2017120291A RU 2017120291 A RU2017120291 A RU 2017120291A RU 2017120291 A RU2017120291 A RU 2017120291A RU 2017120291 A RU2017120291 A RU 2017120291A
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- 239000003814 drug Substances 0.000 title claims 14
- 238000009434 installation Methods 0.000 claims 8
- 229940079593 drug Drugs 0.000 claims 7
- 239000012530 fluid Substances 0.000 claims 6
- 239000000463 material Substances 0.000 claims 6
- 229940124597 therapeutic agent Drugs 0.000 claims 6
- 238000012377 drug delivery Methods 0.000 claims 3
- 239000007943 implant Substances 0.000 claims 3
- 230000035515 penetration Effects 0.000 claims 3
- 210000003786 sclera Anatomy 0.000 claims 3
- 230000000007 visual effect Effects 0.000 claims 3
- 230000004888 barrier function Effects 0.000 claims 2
- 230000006641 stabilisation Effects 0.000 claims 2
- 238000011105 stabilization Methods 0.000 claims 2
- 238000002513 implantation Methods 0.000 claims 1
Classifications
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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
- A61F9/0008—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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- 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
- 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
- A61F2210/0061—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof swellable
-
- 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
- A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
- A61F2250/001—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a diameter
-
- 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
- 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
- A61F2250/0069—Sealing means
Landscapes
- Health & Medical Sciences (AREA)
- Ophthalmology & Optometry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Prostheses (AREA)
- Medicinal Preparation (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Claims (46)
1. Устройство доставки лекарственного средства, выполненное с возможностью по меньшей мере частичной имплантации в глаз, содержащее:
удерживающую структуру, расположенную около области проксимального конца устройства;
проницаемый элемент, соединенный с по меньшей мере частью удерживающей структуры и проходящий внутри нее;
пористый механизм высвобождения лекарственного средства, расположенный в сообщении по текучей среде с выпуском устройства; и
резервуар, имеющий объем, выполненный с возможностью вмещать одно или более терапевтических средств и находиться в сообщении по текучей среде с выпуском через пористый механизм высвобождения лекарственного средства,
при этом устройство выполнено с возможностью по меньшей мере частичной установки внутрь глаза вдоль оси установки,
причем резервуар выполнен с возможностью увеличения от установочной конфигурации, которая имеет первую трехмерную геометрическую форму, до расширенной конфигурации, которая имеет вторую трехмерную геометрическую форму, при этом вторая трехмерная геометрическая форма расположена эксцентрически относительно оси установки.
2. Устройство по п. 1, в котором первая часть объема резервуара в расширенной конфигурации увеличивается от хрусталика глаза и является большей, чем остальная часть объема.
3. Устройство по п. 2, в котором каждая из первой части и остальной части остается за пределами зрительной оси глаза.
4. Устройство по любому из пп. 1–3, в котором резервуар формируют из неподатливого материала.
5. Устройство по п. 4, в котором неподатливый материал резервуара расширяется от первой трехмерной геометрической формы до второй трехмерной геометрической формы, но не проходит за пределы второй трехмерной геометрической формы.
6. Устройство по любому из предшествующих пунктов, в котором определенное расстояние отделяет проксимальный конец резервуара от одной или более внутренних тканевых поверхностей, окружающих место проникновения в глаз, при нахождении в расширенной конфигурации.
7. Устройство по любому из предшествующих пунктов, при этом устройство остается за пределами зрительной оси в расширенной конфигурации.
8. Устройство по любому из предшествующих пунктов, дополнительно содержащее элемент центрального ядра, проходящий от области проксимального конца устройства до области дистального конца устройства.
9. Устройство по п. 8, в котором механизм высвобождения лекарственного средства сопряжен с элементом центрального ядра около области дистального конца устройства, а удерживающая структура сопряжена с элементом центрального ядра около области проксимального конца устройства.
10. Устройство по п. 8 или 9, в котором элемент центрального ядра содержит внутренний просвет и одно или более отверстий, проходящих через стенку элемента центрального ядра.
11. Устройство по п. 10, в котором внутренний просвет элемента центрального ядра находится в сообщении по текучей среде с объемом резервуара через одно или более отверстий.
12. Устройство по пп. 10 или 11, в котором одно или более отверстий направляют поток материала, инъецированного в устройство, в объем резервуара.
13. Устройство по любому из пп. 10-12, в котором элемент центрального ядра имеет цилиндрическую геометрию и дополнительно содержит направитель потока для того, чтобы направлять поток через еще одни отверстия.
14. Устройство по п. 13, в котором направитель потока содержит первую цилиндрическую область, соединенную со второй цилиндрической областью посредством воронкообразной области, при этом первая цилиндрическая область имеет больший диаметр в сечении, чем вторая цилиндрическая область.
15. Устройство по пп. 13 или 14, в котором направитель потока содержит проницаемый барьер, расположенный внутри внутреннего просвета элемента центрального ядра, при этом проницаемый барьер закупоривает внутренний просвет.
16. Устройство по любому из пп. 8-15, в котором удерживающая структура содержит проксимальный фланцевый элемент, выполненный с возможностью проходить за пределы склеры глаза, и шейку, причем шейка имеет проксимальную область, выполненную с возможностью проходить через место проникновения в склере глаза, и дистальное расширение, которое проходит внутрь склеры глаза.
17. Устройство по п. 16, в котором дистальное расширение шейки окружает часть элемента центрального ядра около проксимального конца устройства, обеспечивая стабилизацию шейки для того, чтобы поддерживать положение резервуара.
18. Устройство по п. 16 или 17, в котором дистальное расширение шейки предотвращает контакт между резервуаром и внутренними поверхностями глаза смежно с местом проникновения.
19. Устройство по любому одному из пп. 16-18, в котором верхняя поверхность проксимального фланцевого элемента указывает на ориентацию резервуара в расширенной конфигурации.
20. Устройство по п. 19, в котором верхняя поверхность фланцевого элемента содержит индикатор ориентации, видимый пользователю снаружи глаза.
21. Устройство по п. 20, в котором индикатор ориентации представляет собой геометрическую форму фланцевого элемента или метку на верхней поверхности фланцевого элемента.
22. Устройство по п. 20 или 21, в котором дистальное расширение шейки обеспечивает стабилизацию шейки для того, чтобы поддерживать положение резервуара, как указано индикатором ориентации.
23. Устройство доставки лекарственного средства, содержащее:
область проксимального конца устройства, которая содержит удерживающую структуру и проницаемый элемент, соединенный с по меньшей мере частью удерживающей структуры и проходящий внутри нее; и
область дистального конца устройства, выполненную с возможностью по меньшей мере частичной имплантации в глаз, при этом область дистального конца содержит:
пористый механизм высвобождения лекарственного средства, расположенный в сообщении по текучей среде с выпуском устройства; и
резервуар, имеющий объем, выполненный с возможностью вмещать одно или более терапевтических средств и находиться в сообщении по текучей среде с выпуском через пористый механизм высвобождения лекарственного средства, при этом резервуар выполнен с возможностью увеличения от установочной конфигурации до расширенной конфигурации,
причем после по меньшей мере частичной имплантации в глаз вдоль оси установки, устройство выполнено с возможностью сменять первую геометрическую форму, в которой область дистального конца устройства выравнивают с осью установки, на вторую геометрическую форму, в которой область дистального конца устройства не выравнивают с осью установки.
24. Устройство по п. 23, в котором вторая геометрическая форма представляет собой криволинейную геометрическую форму, которая остается за пределами зрительной оси глаза и избегает контакта с внутренними поверхностями глаза смежно с местом проникновения.
25. Устройство по п. 23 или 24, в котором расширенная конфигурация резервуара содержит симметричное расширение.
26. Устройство по п. 23 или 24, в котором расширенная конфигурация резервуара содержит асимметричное расширение.
27. Устройство доставки лекарственного средства, выполненное с возможностью по меньшей мере частичной имплантации в глаз, содержащее:
резервуар, сформированный из неподатливого материала, формирующего объем, выполненный с возможностью вмещать одно или более терапевтических средств;
элемент центрального ядра, проходящий через объем между областью проксимального конца резервуара и областью дистального конца резервуара, при этом элемент центрального ядра имеет стенку, которая окружает просвет, впуск в просвет, выпуск из просвета, и одно или более отверстий, проходящих через стенку элемента центрального ядра между впуском и выпуском, причем просвет находится в сообщении по текучей среде с объемом резервуара через одно или более отверстий; и
пористый механизм высвобождения лекарственного средства, расположенный внутри выпуска и выполненный с возможностью высвобождать одно или более терапевтических средств из объема через пористый механизм высвобождения лекарственного средства,
при этом неподатливый материал резервуара сворачивают вокруг элемента центрального ядра, формируя первую трехмерную геометрическую форму перед заполнением объема одним или более терапевтическими средствами, когда устройство находится в установочной конфигурации,
причем неподатливый материал резервуара увеличивают в стороны от элемента центрального ядра, формируя вторую трехмерную геометрическую форму при заполнении объема одним или более терапевтическими средствами, когда устройство находится в расширенной конфигурации.
28. Устройство по п. 27, дополнительно содержащее удерживающую структуру, расположенную около области проксимального конца устройства, и проницаемый элемент, соединенный с по меньшей мере частью удерживающей структуры и проходящий внутрь нее.
29. Устройство по п. 27 или 28, дополнительно содержащее направитель потока, расположенный внутри просвета элемента центрального ядра, при этом направитель потока выполнен с возможностью содействовать заполнению объема резервуара.
30. Устройство по п. 29, в котором направитель потока содержит первую цилиндрическую область, соединенную со второй цилиндрической областью посредством воронкообразной области для того, чтобы направлять поток через одно или более отверстий в элементе центрального ядра, причем первая цилиндрическая область имеет больший диаметр в сечении, чем вторая цилиндрическая область.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462077829P | 2014-11-10 | 2014-11-10 | |
| US62/077,829 | 2014-11-10 | ||
| PCT/US2015/059990 WO2016077371A1 (en) | 2014-11-10 | 2015-11-10 | Expandable drug delivery devices and method of use |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| RU2017120291A true RU2017120291A (ru) | 2018-12-13 |
| RU2017120291A3 RU2017120291A3 (ru) | 2019-05-29 |
| RU2708958C2 RU2708958C2 (ru) | 2019-12-12 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2017120291A RU2708958C2 (ru) | 2014-11-10 | 2015-11-10 | Расширяемые устройства доставки лекарственных средств и способы использования |
Country Status (13)
| Country | Link |
|---|---|
| US (3) | US10500091B2 (ru) |
| EP (1) | EP3217924B1 (ru) |
| JP (3) | JP7037360B2 (ru) |
| KR (1) | KR20170106298A (ru) |
| CN (3) | CN110478119B (ru) |
| AU (1) | AU2015346450B2 (ru) |
| BR (1) | BR112017009660A2 (ru) |
| CA (1) | CA2967330A1 (ru) |
| IL (1) | IL252172B (ru) |
| MX (1) | MX383085B (ru) |
| RU (1) | RU2708958C2 (ru) |
| SG (1) | SG11201703726XA (ru) |
| WO (1) | WO2016077371A1 (ru) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2014241163B2 (en) | 2013-03-28 | 2018-09-27 | Forsight Vision4, Inc. | Ophthalmic implant for delivering therapeutic substances |
| ES2992100T3 (es) | 2014-07-15 | 2024-12-09 | Forsight Vision4 Inc | Dispositivo de administración de implante ocular |
| CA2957548A1 (en) | 2014-08-08 | 2016-02-11 | Forsight Vision4, Inc. | Stable and soluble formulations of receptor tyrosine kinase inhibitors, and methods of preparation thereof |
| SG11201703726XA (en) | 2014-11-10 | 2017-06-29 | Forsight Vision4 Inc | Expandable drug delivery devices and method of use |
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2015
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- 2015-11-10 CN CN201910880243.1A patent/CN110478119B/zh active Active
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