Implants with controlled drug delivery features and methods of using same
Disclosed herein are drug delivery devices and methods for the treatment of ocular disorders requiring targeted and controlled administration of a drug to an interior portion of the eye for reduction or prevention of symptoms of the disorder. The devices are capable of controlled release of one or more drugs and may also include structures which allow for treatment of increased intraocular pressure by permitting aqueous humor to flow out of the anterior chamber of the eye through the device.
1. A drug delivery ocular implant comprising:
an outer shell having a proximal end, a distal end, said outer shell being shaped to define an interior space;
at least a first therapeutic agent disposed within said interior space;
a cap positioned on the proximal end of said outer shell,
wherein said cap comprises at least one aperture; and
a permeable or semi-permeable material positioned between said cap and said proximal end of said outer shell,
wherein said permeable or semi-permeable material is permeable to said at least a first therapeutic agent,
wherein said permeable or semi-permeable material is dimensioned based on the permeability of said permeable or semi-permeable material to said at least a first therapeutic agent, and
wherein said permeable or semi-permeable material occludes said at least one aperture, thereby allowing elution of said at least a first therapeutic agent to occur only through said permeable or semi-permeable material;
wherein said proximal end of said outer shell is configured to be positioned in an anterior chamber of an eye.
2. The implant of claim 1 , wherein said at least one first therapeutic agent comprises a prostaglandin, a prostaglandin analog, a prostaglandin inhibitor, and/or combinations thereof.
3. The implant of claim 1 , further comprising at least one fluid inlet and one fluid outlet, wherein said at least one fluid inlet and one fluid outlet are configured to deliver ocular fluid to a physiological outflow pathway.
4. The implant of claim 3 , wherein said physiological outflow pathway is Schlemm's Canal.
5. The implant of claim 3 , wherein the at least one fluid outlet is positioned in closer proximity to the distal end of said outer shell, as compared to the at least one fluid inlet.
6. The implant of claim 1 , wherein said permeable or semi-permeable material is a membrane.
7. The implant of claim 6 , further comprising a retention protrusion on the distal end of said outer shell, wherein said retention protrusion is configured to anchor the ocular implant at a target tissue site.
8. The implant of claim 6 , wherein upon positioning of the cap over the proximal end of the outer shell said cap extends towards said distal end of said outer shell and encloses only a portion of said outer shell.
9. The implant of claim 7 , wherein said retention protrusion comprises a sharpened conical element configured to at least partially penetrate tissue at said target tissue site.
10. A drug delivery ocular implant comprising:
an outer shell having a proximal end, a distal end, said outer shell being shaped to define an interior space;
at least a first therapeutic agent disposed within said interior space;
a cap positioned on the proximal end of said outer shell,
wherein said cap comprises at least one portion permeable or semi-permeable to said at least a first therapeutic agent,
wherein said at least one permeable or semi-permeable portion is dimensioned based on the permeability of said at least one permeable or semi-permeable portion to said at least a first therapeutic agent,
wherein upon placement of the cap over the proximal end of the outer shell, said cap extends towards said distal end of said outer shell and encloses a portion of said outer shell,
wherein elution of said at least a first therapeutic agent occurs only through said at least one permeable or semi-permeable portion; and
wherein said proximal end of said outer shell is configured to be positioned in an anterior chamber of an eye.
11. The implant of claim 10 , wherein said at least a first therapeutic agent comprises a prostaglandin, a prostaglandin analog, a prostaglandin inhibitor, and/or combinations thereof.
12. The implant of claim 10 , further comprising at least one fluid inlet and one fluid outlet, wherein said at least one fluid inlet and one fluid outlet are configured to deliver ocular fluid to a physiological outflow pathway.
13. The implant of claim 10 , wherein the permeable or semi-permeable portion of the cap comprises an aperture.
14. The implant of claim 13 , wherein said permeable or semi-permeable portion of the cap further comprises a material permeable or semi-permeable to said at least a first therapeutic agent.
15. The implant of claim 14 , wherein said material permeable or semi-permeable to said at least a first therapeutic agent is a membrane.
16. The implant of claim 10 , wherein said distal end of said outer shell further comprises a retention protrusion comprising a sharpened conical element configured to anchor said implant at a target tissue site.
17. A drug delivery ocular implant comprising:
an outer shell having a proximal end, a distal end, said outer shell being shaped to define an interior space;
at least a first therapeutic agent disposed within said interior space;
a cap comprising at least one aperture and dimensioned for positioning over the proximal end of the outer shell, wherein the cap extends towards said distal end of said outer shell and encloses a portion of said outer shell,
a first material through which the at least a therapeutic agent elutes positioned between said cap and said proximal end of said outer shell,
wherein said first material is permeable or semi-permeable to said at least a first therapeutic agent and occludes said at least one aperture, thereby allowing elution of said at least a first therapeutic agent to occur only through said first material; and
a retention protrusion comprising a sharpened element on the distal end of said outer shell,
wherein said proximal end of said outer shell is configured to be positioned in an anterior chamber of an eye.
18. The implant of claim 17 , wherein said first material is a membrane.
19. The implant of claim 17 , wherein said first therapeutic agent comprises a prostaglandin, a prostaglandin analog, a prostaglandin inhibitor, and/or combinations thereof.
20. The implant of claim 17 , further comprising at least one fluid inlet and one fluid outlet, wherein said at least one fluid inlet and one fluid outlet are configured to deliver ocular fluid to a physiological outflow pathway.
21. The implant of claim 17 , wherein said first material has a thickness of between about 50 and about 100 microns.
22. The implant of claim 17 , wherein said at least a first therapeutic agent elutes from said ocular implant for a period of time ranging between about 12 to about 48 months.
23. The implant of claim 17 , wherein the outer shell comprises a material selected from, polymers, metals, plastics, ceramics, and mixtures of said materials.