Implantable therapeutic device

• US 10,813,788 B2
• Filed: 06/29/2015
• Issued: 10/27/2020
• Est. Priority Date: 01/29/2009
• Status: Active Grant

• Current Assignee: Forsight Vision4, Inc. (Roche Holding AG)
• Original Assignee: Forsight Vision4, Inc. (Roche Holding AG)
• Inventors: de Juan, Jr., Eugene, Alster, Yair, Farinas, Kathleen Cogan, MacFarlane, K. Angela, Reich, Cary J., Campbell, Randolph E.
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): Ebrahim, Nabila G
• Application Number:
  US14/753,574
• Publication Number:
  US 20150297402A1
• Time in Patent Office: 1,947 Days
• Field of Search: 60428804
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 38/179 for growth factors; for growth regulators
• CPC Class Codes: A61K 39/395 Antibodies agglutinins A61K38/36 ; as drug carriers A61K47/50; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: C07K 16/22 against growth factors ; against growth regulators
• CPC Class Codes: C07K 2317/94 Stability, e.g. half-life, pH, temperature or enzyme-resistance

Abstract

A therapeutic device to release a therapeutic agent comprises a porous structure coupled to a container comprising a reservoir. The reservoir comprises a volume sized to release therapeutic amounts of the therapeutic agent for an extended time when coupled to the porous structure and implanted in the patient. The porous structure may comprise a first side coupled to the reservoir and a second side to couple to the patient to release the therapeutic agent. The length of the channels extending from the first side to the second side may comprise an effective length greater than a distance across the porous structure from the first side to the second side. The therapeutic device may comprise a penetrable barrier to inject therapeutic agent into the device when implanted in the patient.

Claims

1. An ophthalmic drug delivery device for extended release of one or more therapeutic agents into an eye, the device comprising:

an inlet port positioned within a retention structure near a proximal end region of the device;

a penetrable element coupled to and extending within at least a portion of the inlet port;

a rigid, porous drug release structure comprising sintered material and positioned within an outlet of the device and having a first surface and a second opposite surface, the rigid porous structure further comprising a plurality of interconnecting, irregularly shaped channels; and

an expandable reservoir formed of a flexible, non-permeable barrier material and having a reservoir volume configured to contain the one or more therapeutic agents, the reservoir configured to enlarge from a first narrow profile configuration to an expanded profile configuration upon filling with the one or more therapeutic agents,

wherein the porous drug release structure is positioned at a distal end of the device and distal to the reservoir volume, and the first surface of the porous drug release structure is exposed to the reservoir volume and the second surface of the porous drug release structure is exposed to the vitreous of the eye such that the reservoir is in fluid communication with the outlet through the porous drug release structure.

2. The device of claim 1, wherein the one or more therapeutics comprises a drug formulation of ranibizumab.

3. The device of claim 1, wherein the reservoir volume is within a range from about 10 uL to about 100 uL and no more than 200 uL so as to not substantially increase intraocular pressure when the reservoir is in the expanded profile configuration.

4. The device of claim 1, wherein the device is positionable away from a visual path of the eye and intraocular pressure of the eye does not substantially increase upon enlarging the reservoir to the expanded profile configuration.

5. The device of claim 1, further comprising a central hollow body coupled to the inlet port and extending through an interior of the device.

6. The device of claim 5, wherein the hollow body comprises one or more openings allowing the one or more therapeutic agents injected through the inlet port to pass from the hollow body into the reservoir volume.

7. The device of claim 1, wherein the reservoir is configured to be collapsed in cross-section when the device is implanted in the eye towards the first narrow profile configuration for removal from the eye.

8. The device of claim 1, wherein the reservoir is refillable or flushable while the device is implanted in the eye.

9. The device of claim 1, further comprising a support having a proximal annular portion supporting the penetrable element and a distal annular portion supporting the porous drug release structure within the outlet.

10. The device of claim 9, wherein the rigid, porous drug release structure is supported by the distal annular portion positioned near a distal end of the reservoir within the outlet.

11. The device of claim 10, wherein the support is bonded to at least a portion of the reservoir.

12. The device of claim 10, wherein the support is disposed inside the reservoir.

13. The device of claim 10, wherein the support further comprises struts extending axially between the proximal annular portion and the distal annular portion.

14. The device of claim 13, wherein the distal annular portion is moveable relative to the proximal annular portion along a longitudinal axis of the device.

15. The device of claim 9, further comprising a removal system having an elongate structure, wherein the removal system is configured to remove the ophthalmic drug delivery device from the eye.

16. The device of claim 15, wherein the elongate structure is configured to extend through the proximal annular portion to urge the rigid, porous drug release structure distally increasing a length of the reservoir and towards the collapsed profile dimension for removal from the eye.

17. The device of claim 1, wherein the reservoir volume is maintained at a substantially fixed volume once in the expanded profile configuration.

18. The device of claim 1, wherein the first narrow profile configuration has a cross-sectional dimension between 1 mm and 2 mm.

19. The system of claim 1, wherein the eye has neovascular age-related macular degeneration, and optionally wherein the one or more therapeutic agents is an inhibitor of complement factor D.