Apparatus for treating excess intraocular fluid
View Patent ↗Apparatus and methods are provided for treating diseases that produce elevated intraocular pressures, such as glaucoma, wherein the device operates on the principles of a Starling resistor, and includes a housing, a deformable structure and a spring mounted within a housing, such that the spring applies a substantially constant spring force over a predetermined working range on the deformable structure to thereby self-regulate flow of fluid through the deformable structure.
1. A device for the treatment of excess fluid pressure within an eye, the device comprising:
a housing configured to be implanted beneath a conjunctiva;
a deformable tube disposed within the housing, the deformable tube having an exterior surface and a continuous lumen extending between a first end configured for fluid communication with an anterior chamber of the eye and a second end configured to be disposed beneath the conjunctiva, the deformable tube having a variable flow area; and
a spring having a substantially constant spring force within a predetermined working range, the spring mounted within the housing to apply a force on a portion of the exterior surface of the deformable tube sufficient to self-regulate the flow of fluid through the deformable tube.
2. The device of claim 1 , wherein the implantable housing has an inlet port and an outlet port, and the deformable tube extends between the inlet port and outlet port.
3. The device of claim 2 , further comprising a nozzle coupled to the inlet port and configured to pass through a wall of the eye to communicate with the anterior chamber of the eye.
4. The device of claim 1 , wherein the implantable housing is configured to be implanted under a scleral flap.
5. The device of claim 1 , wherein the implantable housing is configured to be implanted above a sclera, the device further comprising a protective patch configured to protect a conjunctival layer from device-induced erosion, wherein the protective patch is positioned above the implantable housing.
6. The device of claim 1 , further comprising a Seton tube configured to be coupled to the second end of the deformable tube.
7. The device of claim 1 , further comprising a drainage tube having a proximal end configured to be coupled to the second end of the deformable tube, a distal region comprising one or more drainage holes configured to be disposed within a space of the eye, and a lumen extending between the proximal end and the one or more drainage holes.
8. The device of claim 7 , wherein the one or more drainage holes are configured to be disposed within an orbital fat space such that the one or more drainage holes permit drainage into the orbital fat space.
9. The device of claim 7 , further comprising a diffuser plate having a groove configured to receive a portion of the drainage tube between the proximal end and the one or more holes of the drainage tube, the diffuser plate further configured to be implanted beneath the conjunctiva and above a sclera.
10. The device of claim 1 , further comprising a diffuser plate configured to be implanted beneath the conjunctiva and above a sclera, wherein the implantable housing is disposed within the diffuser plate.
11. The device of claim 1 , wherein the implantable housing further comprises eyelets configured for suturing the implantable housing in a fixed position.
12. The device of claim 1 , wherein the implantable housing has a radius of curvature selected to accommodate a radius of curvature of the eye.
13. The device of claim 1 , wherein the deformable tube comprises a thermosetting polymer.
14. The device of claim 1 , wherein the spring applies the force on a central portion of the exterior surface of the deformable tube, and wherein the force applied to the deformable tube by the spring is selected to establish a balance between an external pressure at the second end and an internal pressure of the eye at the first end.
15. The device of claim 1 , wherein the deformable tube comprises two deformable sheets welded together along opposing edges of the deformable sheets, or a single flexible sheet configured to be coupled to a rigid chamber to form a cavity.
16. The device of claim 1 , wherein the spring comprises a spiral spring, a coil spring, or a cantilever structure.
17. The device of claim 1 , further comprising a set screw disposed on the housing, the set screw configured to be periodically moved post-implantation to adjust the spring.
18. The device of claim 17 , where the set screw comprises a magnetic head configured to non-invasively adjust the working range of the spring.
19. A device for the treatment of excess fluid pressure within an eye, the device comprising:
a housing configured to be implanted beneath a conjunctiva;
a deformable tube disposed within the housing, the deformable tube having an exterior surface and a continuous lumen extending between an inlet end configured for fluid communication at an inlet pressure with an anterior chamber of the eye and an outlet end configured for fluid communication at an outlet pressure with a space beneath the conjunctiva, the deformable tube having a variable flow area; and
a spring disposed within the housing to apply a force to a portion of the exterior surface of the deformable tube, the spring configured to cooperate with the deformable tube, inlet pressure and outlet pressure over a working range to form a Starling resistor that self-regulates a flow of fluid through the deformable tube.
20. The device of claim 19 , further comprising a pressing element interposed between the spring and the deformable tube.