Posterior segment drug delivery

• US 8,795,712 B2
• Filed: 05/07/2013
• Issued: 08/05/2014
• 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, Eugene Jr., Alster, Yair, Gifford, Hanson S. III, Barrett, Michael, Campbell, Randolph E., Sutton, Douglas
• Primary Examiner(s): Hartley, Michael G
• Assistant Examiner(s): EBRAHIM, NABILA G
• Application Number:
  US13/889,339
• Publication Number:
  US 20130245573A1
• Time in Patent Office: 455 Days
• Field of Search: None
• US Class Current: 424/427
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 38/385 Serum albumin
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 47/38 Cellulose; Derivatives thereof
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: C07K 16/22 against growth factors ; against growth regulators
• CPC Class Codes: C07K 2317/24 containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
• CPC Class Codes: C07K 2317/55 Fab or Fab'
• CPC Class Codes: Y10T 29/49826 Assembling or joining

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. A plurality of interconnecting channels can extend from the first side to the second side so as to connect a first a plurality of openings on the first side with a second plurality of openings on the second side.

Claims

1. A therapeutic device to treat an eye of a patient, the eye having a sclera, the therapeutic device comprising:

a rigid-walled, refillable reservoir having a volume and a distal portion, at least a distal portion of the reservoir adapted to reside inside the eye when the device is implanted in the eye, the reservoir having a cross-sectional shape defined along a plane perpendicular to a longitudinal axis of the device;

a cap portion positioned near the reservoir and adapted to be positioned against an external surface of the sclera when the device is implanted in the eye, the cap portion including at least a portion of a penetrable barrier to introduce the therapeutic agent into the device without any need to explant the device during introduction of the therapeutic agent into the device; and

a neck portion near the cap portion, the neck having a cross-sectional shape defined along a plane perpendicular to a longitudinal axis of the device, wherein the cross-sectional shape of the neck portion is different than the cross-sectional shape of the reservoir.

2. The therapeutic device of claim 1, wherein the neck has a cross-sectional shape which complements the shape of an elongated incision.

3. The therapeutic device of claim 2, wherein the neck conforms to the shape of the incision.

4. The therapeutic device of claim 2, wherein the cross-sectional shape of the neck portion is elongated.

5. The therapeutic device of claim 1, wherein the neck portion is narrowed relative to the cap portion.

6. The therapeutic device of claim 1, wherein the neck portion comprises a cross-sectional shape having a first cross-sectional dimension and a second cross-sectional dimension, such that the first cross-sectional dimension is greater than the second cross-sectional dimension so as to form an elongated profile.

7. The therapeutic device of claim 1, wherein the cross-sectional shape of the neck portion comprises a first transverse dimension and a second transverse dimension longer than the first transverse dimension.

8. The therapeutic device of claim 1, wherein the cross-sectional shape of the neck portion comprises one of a slot, lentoid, oval and ellipse.

9. The therapeutic device of claim 1, wherein the cross-sectional shape of the neck portion corresponds to a shape the scleral incision assumes when the sclera is cut and dilated.

10. The therapeutic device of claim 1, wherein the cross-sectional shape of the neck portion comprises a first curve along a first axis and a second curve along a second axis different than the first curve.

11. The therapeutic device of claim 1, further comprising a rigid, porous structure having a plurality of interconnecting, irregularly shaped channels, the distal portion of the reservoir comprising the porous structure, the porous structure tuned to release a predetermined rate profile of a particular therapeutic agent from the reservoir through the plurality of channels and into the interior of the eye to treat the eye for an extended period of time.

12. A therapeutic device to treat an eye of a patient, the eye having a sclera, the therapeutic device comprising:

a rigid-walled, refillable reservoir having a volume and a distal portion, at least a distal portion of the reservoir adapted to reside inside the eye when the device is implanted in the eye, the reservoir having a cross-sectional shape defined along a plane perpendicular to a longitudinal axis of the device;

a cap portion positioned near the reservoir and adapted to be positioned against an external surface of the sclera when the device is implanted in the eye, the cap portion including at least a portion of a a penetrable barrier to introduce the therapeutic agent into the device without any need to explant the device during introduction of the therapeutic agent into the device; and

a neck portion near the cap portion, the neck portion having a cross-sectional shape defined along a plane perpendicular to a longitudinal axis of the device, wherein the cross-sectional shape of the neck portion complements the shape of an incision in the eye through which the device is introduced into the eye such that eye tissue seals around the neck portion when the device is implanted in the eye, and wherein the cross-sectional shape of the neck portion is different than the cross-sectional shape of the reservoir.

13. The therapeutic device of claim 12, wherein the neck has a cross-sectional shape which complements the shape of an elongated incision.

14. The therapeutic device of claim 12, wherein the neck conforms to the shape of the incision.

15. The therapeutic device of claim 12, wherein the cross-sectional shape of the neck portion is elongated.

16. The therapeutic device of claim 12, wherein the neck portion is narrowed relative to the cap portion.

17. The therapeutic device of claim 12, wherein the neck portion comprises a cross-sectional shape having a first cross-sectional dimension and a second cross-sectional dimension, such that the first cross-sectional dimension is greater than the second cross-sectional dimension so as to form an elongated profile.

18. The therapeutic device of claim 12, wherein the cross-sectional shape of the neck portion comprises a first transverse dimension and a second transverse dimension longer than the first transverse dimension.

19. The therapeutic device of claim 12, wherein the cross-sectional shape of the neck portion comprises one of a slot, lentoid, oval and ellipse.

20. The therapeutic device of claim 12, wherein the cross-sectional shape of the neck portion corresponds to a shape the scleral incision assumes when the sclera is cut and dilated.

21. The therapeutic device of claim 12, wherein the cross-sectional shape of the neck portion comprises a first curve along a first and a second curve along a second axis different than the first curve.

22. The therapeutic device of claim 12, further comprising a rigid, porous structure having a plurality of interconnecting, irregularly shaped channels, a portion of the reservoir comprising the porous structure, the porous structure tuned to release a predetermined rate profile of a particular therapeutic agent from the reservoir through the plurality of channels and into the interior of the eye to treat the eye for an extended period of time.