Posterior segment drug delivery

• US 9,851,351 B2
• Filed: 12/17/2015
• Issued: 12/26/2017
• 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: Reich, Cary J., Barrett, Michael, Campbell, Randolph E., Farinas, Kathleen C.
• Primary Examiner(s): Hartley, Michael G
• Assistant Examiner(s): EBRAHIM, NABILA G
• Application Number:
  US14/973,311
• Publication Number:
  US 20160101046A1
• Time in Patent Office: 740 Days
• Field of Search: 604 612, 604506, 7315225
• 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: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• 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 method of manufacturing a porous structure configured to be used with a therapeutic device implantable in the eye for prolonged treatment, the method comprising:

performing a non-destructive test on at least one porous structure, the at least one rigid porous structure configured to be coupled to a distal portion of a refillable reservoir for containing at least one therapeutic agent of a therapeutic device implantable for prolonged treatment, the non-destructive test relying on forced gas flow through the at least one porous structure, the rigid porous structure having a plurality of interconnecting channels;

obtaining from the non-destructive test at least one performance result for the at least one porous structure, the performance result comprising a gas flow rate;

measuring a diffusion rate of a drug passively diffusing through the at least one porous structure to obtain a measured diffusion rate; and

correlating the at least one performance result of the at least one porous structure to the measured diffusion rate so as to form a correlation that predicts the diffusion rate of the drug through a porous structure.

2. The method as in claim 1, further comprising:

performing the non-destructive test on at least a second porous structure;

obtaining from the non-destructive test at least one performance result for the at least a second porous structure; and

predicting, based on the correlation, a diffusion rate of the drug through the at least a second porous structure to obtain a predicted diffusion rate.

3. The method as in claim 2, further comprising identifying the at least a second porous structure as suitable for assembly with the therapeutic device.

4. The method as in claim 2, wherein the predicted diffusion rate corresponds to the diffusion rate of the drug through the at least one porous structure.

5. The method as in claim 2, further comprising measuring a diffusion rate of a drug through the at least a second porous structure to obtain a second measured diffusion rate and comparing the second measured diffusion rate to the predicted diffusion rate.

6. The method as in claim 5, wherein measuring is performed prior to manufacturing the device with the second porous structure.

7. The method as in claim 5, wherein measuring is performed after manufacturing the device with the second porous structure.

8. The method as in claim 2, further comprising manufacturing the therapeutic device with the second porous structure without measuring a diffusion rate of a drug through the at least a second porous structure and comparing to the predicted diffusion rate.

9. The method as in claim 1, wherein the non-destructive test is performed on the at least one porous structure prior to assembling the at least one porous structure with the therapeutic device.

10. The method as in claim 1, wherein the non-destructive test is performed on the at least one porous structure after at least partially assembling the at least one porous structure with the therapeutic device.

11. The method as in claim 10, wherein the at least partially assembled therapeutic device includes a therapeutic agent contained in a reservoir.

12. The method as in claim 1, wherein the non-destructive test is performed as a quality control inspection test upon receipt of the at least one porous structure from a manufacturer.

13. The method as in claim 1, wherein the non-destructive test is performed as a quality control inspection test after final assembly of the therapeutic device.

14. The method as in claim 1, wherein the non-destructive test is a test that does not involve drug release through the at least one porous structure.

15. A therapeutic device manufactured according to the method of claim 1.