Posterior segment drug delivery

Patent metadata

Field	Value
Publication number	US-10656152-B2
Application number	US-201715807396-A
Country	US
Kind code	B2
Filing date	Nov 8, 2017
Priority date	Jan 29, 2009
Publication date	May 19, 2020
Grant date	May 19, 2020

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.

First claim

What is claimed is:

1. A therapeutic device to treat an eye of a patient, the eye having a posterior segment and a sclera, the therapeutic device comprising:
a rigid-walled, refillable reservoir having a volume, the reservoir adapted to reside in the posterior segment when the device is implanted in the eye;
a rigid, porous structure located at a distal region of the reservoir comprising sintered material;
a proximal cap portion positioned proximal of the reservoir and adapted to be positioned outside the sclera when the device is implanted in the eye, the cap portion comprising a retention structure and a penetrable, non-permeable 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 positioned between the cap portion and the reservoir portion and defined by a cross-sectional shape that is smaller than a cross-sectional shape of the reservoir and a cross-sectional shape of the cap portion,
wherein the cross-sectional shape of the neck portion is non-circular and the cross-sectional shape of the reservoir is circular, and the sclera is positioned about the neck portion when the device is positioned in the eye.

2. The therapeutic device of claim 1 , wherein the porous structure and reservoir chamber are tuned to release a predetermined rate profile of a particular therapeutic agent from the reservoir into the posterior segment to treat the eye for an extended period of time.

3. The therapeutic device of claim 1 , wherein the volume of the refillable reservoir remains substantially unchanged and the rigid porous structure remains rigid when the reservoir is pressurized with injection of therapeutic agent into the reservoir.

4. The therapeutic device of claim 1 , further comprising a porous, protective barrier configured to allow the therapeutic agent to pass from the reservoir through the protective barrier while inhibiting penetration of at least one of a bacterial cell or an immune cell through the protective barrier into the reservoir.

5. The therapeutic device of claim 1 , wherein the device extends along an axis so as to extend through the sclera and a choroid into the posterior segment, and wherein the penetrable barrier of the proximal cap portion is located on a proximal end of the reservoir so as to allow refill of the reservoir with advancement of an injection needle through a conjunctiva and the penetrable barrier without the needle penetrating the sclera or choroid.

6. The therapeutic device of claim 1 , wherein the sintered material of the rigid, porous structure comprises at least one of a metal, a ceramic, and a glass.

7. The therapeutic device of claim 1 , wherein the sintered material comprises a plurality of irregularly shaped channels.

8. The therapeutic device of claim 7 , wherein at least some of the plurality of irregularly shaped channels intersect at a plurality of locations.

9. The therapeutic device of claim 7 , wherein the rigid, porous structure comprises a thickness and a surface area corresponding to a rate of release of the therapeutic agent over the extended time.

10. The therapeutic device of claim 9 , wherein the thickness extends between a first side and a second side of the structure, and wherein the plurality of irregularly shaped channels extends between the first side and the second side and wherein the plurality of irregularly shaped channels have an effective length extending from the first side of the porous structure to the second side of the porous structure, the effective length greater than the thickness of said structure.

11. The therapeutic device of claim 1 , wherein the porous structure comprises a porosity, a thickness, a channel parameter and a surface area configured to release therapeutic amounts for the extended period.

12. The therapeutic device of claim 11 , wherein the channel parameter comprises a fit parameter corresponding to an effective length of a plurality of irregularly shaped channels extending from a first side of the porous structure to a second side of the porous structure.

13. The therapeutic device of claim 12 , wherein the rate of release of the therapeutic agent through the porous structure corresponds to a ratio of the porosity to the channel parameter and wherein the ratio of the porosity to the channel parameter is less than about 0.5 such that the porous structure is capable of releasing the therapeutic agent for the extended period.

14. The therapeutic device of claim 1 , wherein when implanted, the proximal cap portion is adapted to rest against and conform to a curvature of the sclera and to reside underneath a conjunctiva of the eye.

15. The therapeutic device of claim 1 , wherein the therapeutic agent comprises a half-life within the reservoir of at least about 20 days when the device is implanted, and wherein the device is adapted to remain implanted in the eye and to treat the eye with the therapeutic agent for at least about 90 days.

16. The therapeutic device of claim 1 , wherein the therapeutic agent comprises a half-life within the reservoir of at least about 30 days when implanted, and wherein the device is adapted to remain implanted in the eye and to treat the eye with the therapeutic agent for at least about 120 days.

17. The therapeutic device of claim 1 , wherein the reservoir comprises a volume and the rigid porous structure comprises a release rate adapted to provide the therapeutic agent with a half-life within the reservoir when implanted into the eye, the half-life within the reservoir substantially greater than a corresponding half-life of the therapeutic agent when injected directly into the vitreous and the half-life within the reservoir corresponding to release of therapeutic amounts for at least about 120 days.

18. The therapeutic device of claim 1 , wherein the porous structure comprises a release rate index of no more than about 5.0 mm.

19. The therapeutic device of claim 1 , wherein the volume of the reservoir is sized to contain the quantity of the therapeutic agent for release over a predetermined extended time and wherein the rigid, porous structure comprises a thickness and a surface area corresponding to a rate of release of the therapeutic agent and wherein the volume and the rate of release correspond to a half-life of the therapeutic agent in the reservoir.

20. The device of claim 1 , wherein the rigid porous structure comprises a first side having a first area, a second side having a second area corresponding substantially to the first area, a thickness extending between the first side and the second side, a porosity, and a channel parameter corresponding to a release of the therapeutic agent from the reservoir to the posterior segment of the eye.

21. The therapeutic device of claim 1 , wherein the particular therapeutic agent comprises a molecular weight within a range from 100 Daltons to about 1,000,000 Daltons and wherein the molecular weight corresponds to the predetermined release rate profile.

22. The therapeutic device of claim 1 , wherein the particular therapeutic agent comprises one or more compounds of 2-Methoxyestradiol analogs, 3-aminothalidomide, 13-cis retinoic acid, A0003, A5b1 integrin inhibitor, Abarelix, Abatacept, Abciximab, ABT-578, Acetonide, Adalimumab, Aldesleukin, Alefacept, Alemtuzumab, Alpha-1-proteinase inhibitor, Alteplase, AMG-1470, Anakinra, Anecortave acetate, Angiostatin, Anistreplase, Anti-angiogenesis peptides, Anti-angio

Assignees

• Forsight Vision4 Inc

Inventors

• De Juan Jr Eugene
• Alster Yair
• Chamow Steven M
• Farinas Kathleen C
• Gifford Iii Hanson S
• Macfarlane K Angela
• Reich Cary J
• Barrett Michael
• Campbell Randolph E
• George Robert
• Sutton Douglas

Classifications

• Y10T29/49826

  Assembling or joining · CPC title

• A61K38/385

  Serum albumin · CPC title

• A61K31/573

  substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone · CPC title

• A61K2039/505

  comprising antibodies · CPC title

• A61P27/02

  Ophthalmic agents · CPC title