OPHTHALMIC DRUG DELIVERY DEVICE

Abstract

An ophthalmic liquid delivery apparatus includes a bulbar conjunctiva contacting surface, a palpebral conjunctiva contacting surface which is opposite the bulbar conjunctiva contacting surface, a therapeutic storage reservoir, and at least one fluid delivery port. In addition, a fill system for a liquid filled device includes a liquid feed tube, a plug rod feed tube, a junction port for the liquid feed tube and plug rod feed tube to meet, a needle output to temporarily interface with an ophthalmic liquid delivery device during the filling and plug step, and a cutting tool to cut the plug rod once the device is filled.

Claims

1. An ophthalmic liquid delivery apparatus comprising: a bulbar conjunctiva contacting surface; a palpebral conjunctiva contacting surface which is opposite the bulbar conjunctiva contacting surface; a therapeutic storage reservoir; and at least one fluid delivery port.

2. The apparatus of claim 1, wherein the ocular surface contacting surface has the same curvature as the sclera of the human eye.

3. The apparatus of claim 1, wherein the at least one fluid delivery port comprises a modular flow resistor to control the flow rate.

4. The apparatus of claim 1, further comprising a fill port.

5. The apparatus of claim 1, further comprising a therapeutic liquid within the therapeutic storage reservoir.

6. The apparatus of claim 1, further comprising a lyophilized therapeutic within the therapeutic storage reservoir.

7. The apparatus of claim 6, wherein the bulbar conjunctiva contacting surface allows for water vapor to pass into the therapeutic storage reservoir.

8. The apparatus of claim 6, wherein the palpebral conjunctiva contacting surface allow for water vapor to pass into the therapeutic storage reservoir.

9. The apparatus of claim 3, wherein the modular flow resistor's fluid pathway consists of a flexible material.

10. The apparatus of claim 1, wherein the thickest portion is the therapeutic liquid storage reservoir with a thickness less than 1.5 mm.

11. The apparatus of claim 1, wherein the therapeutic liquid storage reservoir has a curvature to secure the device within the superior or inferior conjunctival fornix of the human eye.

12. The apparatus of claim 1, wherein the surface opposite the ocular surface contacting surface comprises one or more protrusions to help secure the device against the palpebral conjunctiva.

13. The apparatus of claim 1, further comprising an over-molded layer of silicone hydrogel.

14. The apparatus of claim 13, wherein the over-molded layer of silicone hydrogel has one or more channels to allow for water vapor diffusion.

15. The apparatus of claim 1, wherein the fluid delivery port further comprises an anti-bacterial membrane filter.

16. The apparatus of claim 1, wherein the apparatus is asymmetrical when comparing the medial nasal portion vs. the lateral portion of the apparatus.

17. The apparatus of claim 1, further comprising a one-way check valve between the therapeutic storage reservoir and the fluid delivery port.

18. The apparatus of claim 1, further comprising a variable resistance check valve between the therapeutic storage reservoir and the fluid delivery port.

19. A fill system for a liquid filled device comprising: a liquid feed tube; a plug rod feed tube; a junction port for the liquid feed tube and plug rod feed tube to meet; a needle output to temporarily interface with an ophthalmic liquid delivery device during the filling and plug step; and a cutting tool to cut the plug rod once the device is filled.

20. The fill system of claim 19, further comprising an indexed holder to serially bring subsequent ophthalmic liquid delivery devices in temporary contact with the needle of the fill system during fill and seal process of the ophthalmic liquid delivery devices.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0032] In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments of the present invention are described with reference to the following drawings, in which:

[0033] FIGS schematically illustrate components of a representative embodiment.

[0034] FIG. 1 illustrates a front view of an ophthalmic liquid delivery apparatus.

[0035] FIG. 2 illustrates a bottom view of an ophthalmic liquid delivery apparatus.

[0036] FIG. 3A illustrates a right side view of an ophthalmic liquid delivery apparatus in a non-filled state.

[0037] FIG. 3B illustrates a right side view of an ophthalmic liquid delivery apparatus in a filled state.

[0038] FIG. 4 illustrates a left side view of an ophthalmic liquid delivery apparatus.

[0039] FIG. 5 illustrates a back view of an ophthalmic liquid delivery apparatus.

[0040] FIG. 6 illustrates an isometric view of an ophthalmic liquid delivery apparatus.

[0041] FIG. 7 illustrates a front view of an ophthalmic liquid delivery apparatus with integrated foil cover.

[0042] FIG. 8A illustrates a top view modular flexible flow restrictor.

[0043] FIG. 8B illustrates a cross sectional view of a modular flexible flow restrictor.

[0044] FIG. 9A-D illustrates a fill port being accessed by a custom fill needle and the subsequent fill procedure, plugging of the fill port, and removal of the needle.

[0045] FIG. 10 illustrates an embodiment of an automated fill system.

[0046] FIG. 11 illustrates the process map of an embodiment of an automated fill system and indexed device holder.

[0047] FIG. 12A-E illustrates the cross section of the process of creating a lyophilized drug pellet and cross-linked hydrogel within the therapeutic storage reservoir.

[0048] FIG. 13A-E illustrates the top view of the process of creating a lyophilized drug pellet and cross-linked hydrogel within the therapeutic storage reservoir.

DETAILED DESCRIPTION

[0049] Generally, ophthalmic liquid delivery apparatuses are described herein. In various embodiments, the present invention relates generally to an ophthalmic drug delivery device designed to be placed primarily in the superior or inferior conjunctival fornix of the human eye.

[0050] FIG. 1 illustrates a front view of an ophthalmic liquid delivery apparatus. Ophthalmic liquid delivery apparatus 100 includes a therapeutic storage reservoir 110, a fluid delivery port 140, and a fill port 150 within the device. The device is further defined by a palpebral conjunctiva contacting surface, a bulbar conjunctiva contacting surface (not shown), an upper edge 160 of the device, and a lower edge 170 of the device. The perimeter including the edges and portions adjacent the fluid delivery port 140 and fill port 150 are tapered to improve comfort of the device and durable enough to withstand the sheer stresses.

[0051] FIG. 2 illustrates a bottom view of an ophthalmic liquid delivery apparatus.

[0052] FIG. 3A illustrates a right side view of an ophthalmic liquid delivery apparatus in a non-filled state. The walls of the therapeutic storage reservoir 310 is flexible and slowly collapses as the drug is expelled. Therefore, the approximate fill amount can be confirmed visually and by palpitation of the central portion of the device.

[0053] FIG. 3B illustrates a right side view of an ophthalmic liquid delivery apparatus in a filled state. The therapeutic storage reservoir 310 is flexible and is in the expanded state. Due to the shape and size of the fornix, the thickness of the therapeutic storage reservoir 310 walls can be adjusted to predominately favor expansion toward the palpebral conjunctiva contacting surface 330.

[0054] FIG. 4 illustrates a left side view of an ophthalmic liquid delivery apparatus.

[0055] FIG. 5 illustrates a back view of an ophthalmic liquid delivery apparatus.

[0056] FIG. 6 illustrates an isometric view of an ophthalmic liquid delivery apparatus.

[0057] FIG. 7 illustrates a front view of an ophthalmic liquid delivery apparatus with integrated foil cover.

[0058] FIG. 8A illustrates a top view modular flexible flow restrictor 700. The modular flexible flow restrictor 700 comprises the following components: fluidic connector 710 to therapeutic storage reservoir, fluidic channel 720 for flow restriction, fluid delivery port 730. Optionally, an anti-bacterial membrane filter 740 is placed on the fluid delivery port 730 to ensure there is no bacterial ingrowth from adjacent ocular tissues. The fluid delivery port 730 preferably has multiple exit ports or is in the shape of a large surface area exit port to prevent protein clogging during the duration of device use.

[0059] FIG. 8B illustrates a cross sectional view of a modular flexible flow restrictor in which the placement of the anti-bacterial membrane filter 740 can be seen.

[0060] FIG. 9A-D illustrates a fill port being accessed by a custom fill needle and the subsequent fill procedure, plugging of the fill port, and removal of the needle.

[0061] FIG. 10 illustrates an embodiment of an automated fill system.

[0062] FIG. 11 illustrates the process map of an embodiment of an automated fill system and indexed device holder.

[0063] FIG. 12A-E illustrates the cross section of the process of creating a lyophilized drug pellet and cross-linked hydrogel within the therapeutic storage reservoir. One exemplary embodiment of manufacturing the lyophilized drug within the therapeutic storage reservoir is provided below. In the first step, a single layer of silicone is spun and cured in an appropriate shape. In the second step, a hydrogel with photo-initiator is placed as a second layer on top of the silicone. In the third step, a photomask of a specific pattern is placed on the hydrogel to define the specific shape of the hydrogel to be crosslinked. The non-masked hydrogel area is crosslinked using ultraviolet or other known methodologies of crosslinking the hydrogel. The photomask is removed. The drug pellet of lyophilized drug is placed in the desired crosslinked hydrogel area. Finally, a secondary layer of silicone is deposited to create an encapsulated reservoir containing the drug pellet.

[0064] FIG. 13A-E illustrates the top view of the process of creating a lyophilized drug pellet and cross-linked hydrogel within the therapeutic storage reservoir.

[0065] The terms and expressions employed herein are used as terms and expressions of description and not of limitation, and there is no intention, in the use of such terms and expressions, of excluding any equivalents of the features shown and described or portions thereof. In addition, having described certain embodiments of the invention, it will be apparent to those of ordinary skill in the art that other embodiments incorporating the concepts disclosed herein may be used without departing from the spirit and scope of the invention. Accordingly, the described embodiments are to be considered in all respects as only illustrative and not restrictive.