Device and method for reducing intraocular pressure

• US 10,201,451 B2
• Filed: 08/29/2014
• Issued: 02/12/2019
• Est. Priority Date: 08/29/2014
• Status: Active Grant

• Current Assignee: Alievio, Inc.
• Original Assignee: Camras Vision Inc.
• Inventors: Camras, Lucinda J., Allingham, Rand, Klitzman, Bruce, Asrani, Sanjay
• Primary Examiner(s): Deak, Leslie
• Application Number:
  US14/473,228
• Publication Number:
  US 20160058615A1
• Time in Patent Office: 1,628 Days
• Field of Search: 604 7- 10, 604 30, 604264, 604 609, 604 61, 606153, 606108
• CPC Class Codes: A61F 2250/0024 made from both porous and non-porous parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0051 differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

An apparatus is provided for draining aqueous humor from an eye for reducing intraocular pressure. The draining apparatus comprises a tube defining a passage for fluid flow between an inlet end and an outlet end. An outlet assembly contacts the conjunctival layer externally of the eyeball. The outlet assembly comprises a housing in fluid communication with the outlet end of the tube and having an aperture for allowing egress of aqueous humor onto the external ocular surface. A resistive component is disposed in the housing for providing resistance to a flow of aqueous humor. A pair of tabs project outwardly and are adapted to be disposed subconjunctivally for securing the draining apparatus relative to the eyeball.

Claims

1. An apparatus for draining aqueous humor from an eye for reducing intraocular pressure, the eye having an anterior chamber and including a cornea, a surrounding marginal limbus by which the cornea is continuous with a scleral layer and a conjunctival layer, and an exposed ocular surface of the eye and under eyelids, the draining apparatus comprising:

a tube extending between an inlet end configured to be disposed at the anterior chamber of the eyeball and an outlet end, the tube defining a passage for fluid flow between the inlet end and the outlet end; and

an outlet assembly having an inner surface and an outer surface and configured to be disposed such that the inner surface contacts the conjunctival layer externally of the eyeball, the outlet assembly comprising

a housing defining a cavity in fluid communication with the outlet end of the tube and having an aperture opening into the cavity for allowing egress of aqueous humor onto the external ocular surface,

a resistive component disposed in the cavity of the housing between the outlet end of the tube and the aperture, the resistive component configured for providing resistance to a flow of aqueous humor for controlling the flow through the tube from the anterior chamber of the eyeball to the external ocular surface, and

a pair of tabs projecting outwardly in opposite directions from the housing, the tabs adapted to be disposed subconjunctivally for securing the draining apparatus relative to the eyeball.

2. The draining apparatus of claim 1, wherein the tube has a length sufficient to extend from the anterior chamber to the external ocular surface of the eye under the eyelid.

3. The draining apparatus of claim 1, wherein the inlet end of the tube is beveled.

4. The draining apparatus of claim 1, wherein the tube is collapsible.

5. The draining apparatus as recited in claim 1, wherein the aperture in the housing forms a one-way valve for allowing fluid to exit the housing, the aperture having a closed position and an open position, the aperture moving to the open position in response to a predetermined pressure differential within the passage and on opposing sides of the aperture such that aqueous humor flows from the anterior chamber to the external ocular surface at intraocular pressures greater than a threshold pressure.

6. The draining apparatus as recited in claim 5, wherein the aperture is an elongated slit.

7. The draining apparatus as recited in claim 1, wherein the resistive component is configured to be removable via the aperture for facilitating replacement of the resistive component for controlling fluid flow without removing the draining apparatus.

8. The draining apparatus of claim 1, wherein each of the tabs defines an opening for passing a suture.

9. The draining apparatus as recited in claim 1, further comprising an anchor member disposed on an outer surface of the tube, the anchor member configured to engage the tissue of the eyeball when the tube is implanted in the eye.

10. The draining apparatus as recited in claim 9, wherein the anchor member is adjacent the inlet end of the tube.

11. The draining apparatus as recited in claim 9, wherein the anchor member comprises at least one generally triangular flange extending outwardly from the outer surface of the tube.

12. The draining apparatus as recited in claim 11, wherein the at least one generally triangular flange comprises a plurality of flanges longitudinally spaced along the outer surface of the tube.

13. The draining apparatus as recited in claim 12, wherein the plurality of flanges are disposed along the distal end of the tube.

14. The draining apparatus as recited in claim 9, wherein the anchor member comprises a plurality of axially spaced projections formed on the outside surface of the tube and angled radially outwardly toward the outlet end.

15. The draining apparatus as recited in claim 14, wherein the projections are integrally formed along the exterior of the tube.

16. The draining apparatus as recited in claim 9, wherein the anchor member comprises at least one circumferential groove formed in the outside surface of the tube.

17. The draining apparatus as recited in claim 1, further comprising a suture bar disposed on the outer surface of the tube, the suture bar configured to abut the surface of the eye for securing the tube with a suture to the eye.

18. The draining apparatus as recited in claim 1, wherein the resistive component is expandable.

19. The draining apparatus as recited in claim 1, further comprising a sheath for accommodating the resistive component.

20. The draining apparatus as recited in claim 19, wherein the sheath has openings along the length of the sheath.

21. The draining apparatus as recited in claim 19, wherein the sheath comprises a shape-memory material that changes in size for allowing the resistive component to fit snugly in cavity.

22. The draining apparatus as recited in claim 1, wherein the resistive component comprises a porous filter material in which one layer has an average pore diameter less than or equal to about 0.4 um for preventing bacterial infiltration into the anterior chamber.

23. The draining apparatus as recited in claim 1, wherein a porosity of the resistive component is configured to selectively optimize a flow of aqueous humor.

24. The draining apparatus as recited in claim 1, wherein the resistive component has a length, and wherein the length of the resistive component is selectively predetermined for controlling intraocular pressure.

25. The draining apparatus as recited in claim 24, wherein the average pore diameter of the filter material continually increases along the length of the filter.

26. The draining apparatus as recited in claim 1, wherein the outlet assembly comprises an outwardly projecting ridge member integrally formed on the outer surface of the outlet assembly and concentric with the valve opening.

27. The draining apparatus as recited in claim 1, further comprising a layer of growth-stimulating porous cellular ingrowth material disposed substantially on at least a portion of an outer surface of the tube or the outlet assembly to promote ingrowth of the conjunctival layer.

28. The draining apparatus as recited in claim 27, wherein the layer of growth-stimulating material comprises hydroxyapatite or porous polyethylene.

29. The draining apparatus as recited in claim 1, further comprising a filter disposed in the passage between the inlet end of the tube and the resistive component.

30. A method for controlling intraocular pressure within an eye, the eye having an anterior chamber with aqueous humor therein, a cornea and a surrounding marginal limbus by which the cornea is continuous with a layer of scleral tissue and a layer of conjunctival tissue disposed on an exposed ocular surface of the eye and under eyelids, the method comprising the steps of:

providing a device for draining aqueous humor from the eye, the draining device comprising

a tube extending between an inlet end and an outlet end, the tube defining a passage for fluid flow between the inlet end and the outlet end, and

an outlet assembly having an inner surface and an outer surface, the outlet assembly comprising

a housing defining a cavity in fluid communication with the outlet end of the tube and having an aperture opening into the cavity for allowing egress of aqueous humor,

a resistive component disposed in the cavity of the housing between the outlet end of the tube and the aperture, the resistive component configured for providing resistance to a flow of aqueous humor for controlling the flow through the tube from the anterior chamber of the eyeball to the external ocular surface, and

a pair of tabs projecting outwardly in opposite directions from the housing;

implanting the draining device in the eye such that aqueous humor flows through the tube from the anterior chamber of the eye to the external ocular surface; and

securing the tabs under the conjunctival layer.

31. The method for controlling intraocular pressure as recited in claim 30, wherein the step of implanting the draining device comprises:

cutting an incision in the conjunctiva;

advancing the inlet end of the tube within the incision under the conjunctiva;

penetrating the eye tissue at an insertion site near the limbus of the eye;

passing the inlet end of the tube at the insertion site inwardly into the anterior chamber of the eye;

positioning the outlet assembly externally of the conjunctiva under the eyelid;

conducting aqueous humor in the anterior chamber from the inlet end of the tube to the external ocular surface; and

regulating the flow of aqueous humor.

32. The method for controlling intraocular pressure as recited in claim 31, further comprising the step of securing a portion of the tube to the ocular tissue.

33. The method for controlling intraocular pressure as recited in claim 31, further comprising the step of removing and replacing the resistive component.

34. The method for controlling intraocular pressure as recited in claim 31, wherein the method is used to treat dry eye.