Method and apparatus for reducing intraocular pressure

• US 10,524,958 B2
• Filed: 09/30/2015
• Issued: 01/07/2020
• Est. Priority Date: 09/30/2015
• Status: Active Grant

• Current Assignee: Alievio, Inc.
• Original Assignee: Alievio, Inc.
• Inventors: Camras, Lucinda, Ypma, Rolf Erik
• Primary Examiner(s): Deak, Leslie R
• Application Number:
  US14/871,095
• Publication Number:
  US 20170087016A1
• Time in Patent Office: 1,560 Days
• Field of Search: 604 7- 10, 604264, 604 30, 604 609, 604 61, 606153, 606108
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• 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 for reducing intraocular pressure is provided. A tube extends from an inlet end in fluid communication with an anterior chamber of the eye, to direct an aqueous humor flow from the anterior chamber to an outlet end in fluid communication with a cavity, defined by a housing, for receiving the aqueous humor. A proximal end of an elongate tubular member defining a longitudinally-extending channel is engaged with the housing such that the channel is in fluid communication with the cavity and such that a distal end of the tubular member is spaced apart from the housing, wherein the channel is configured to receive the aqueous humor from the cavity and to direct the aqueous humor through the distal end to a drainage site disposed distally to the anterior chamber and to the housing. An associated method is also provided.

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 external ocular surface of the eye under an eyelid, the apparatus comprising:

a first tube extending, along a first axis, between an inlet end and an outlet end, the inlet end being adapted to be in fluid communication with the anterior chamber of the eye, and the first tube being adapted to direct a flow of aqueous humor from the anterior chamber and through the inlet end to the outlet end;

a housing defining a cavity in fluid communication with the outlet end of the first tube, the cavity being configured to receive the aqueous humor;

a second tube extending along a second axis, the second axis being perpendicular to the first axis of the first tube, the second tube having opposed proximal and distal ends and defining a longitudinally-extending channel, the second tube having a proximal opening disposed at the proximal end and a distal opening disposed at the distal end, the proximal end of the second tube being disposed in the housing and the distal end being spaced from the housing, the channel being in fluid communication with the cavity and configured to receive, through the proximal opening, the aqueous humor from the cavity and to direct the aqueous humor through the distal opening to a drainage site disposed distally to the anterior chamber and to the housing; and

a flow control device operably engaged with the second tube and configured to control the flow of the aqueous humor from the cavity and through the distal opening of the second tube to the drainage site.

2. The apparatus of claim 1, wherein the flow control device defines a conduit in communication between the cavity and the drainage site, the conduit being dilatable in response to the intraocular pressure being above a preselected pressure, to increase the flow or to decrease resistance to the flow of the aqueous humor through the second tube to the drainage site and to reduce the intraocular pressure to no greater than the preselected pressure.

3. The apparatus of claim 1, comprising a filter device disposed in fluid communication between the inlet end of the first tube and the flow control device, the filter device being configured to filter contaminants from the aqueous humor prior to the flow control device.

4. The apparatus of claim 3, wherein the filter device is engaged with the housing subsequent to the outlet end of the first tube, and wherein the housing is configured such that the flow control device operably engaged therewith is removable or replaceable with respect to the housing, so as to allow the filter device to be removed or replaced.

5. The apparatus of claim 1, comprising a filter device disposed in fluid communication between the flow control device and the distal end of the second tube, the filter device being configured to filter contaminants from any backflow to the flow control device from the drainage site.

6. The apparatus of claim 5, wherein the filter device is configured to be removable or replaceable with respect to the second tube.

7. The apparatus of claim 5, wherein the filter device is engaged with the second tube.

8. The apparatus of claim 7, wherein the second tube having the filter device engaged therewith is configured to be removable or replaceable with respect to the housing, and the filter device is configured to be removable or replaceable with respect to the second tube.

9. The apparatus of claim 1, comprising an anchoring device operably engaged with the first tube or the housing, the anchoring device being configured to engage the eye subconjunctivally so as to secure at least the first tube or the housing to the eye.

10. The apparatus of claim 1, wherein the second tube is configured to be collapsible on removal of the flow control device.

11. The apparatus of claim 1, further comprising a medicinal agent applied to the flow control device for preventing occlusion or bacterial contamination thereof by inhibiting the formation of fibrotic membranes, inflammatory membranes, bacterial adhesions, or biofilms.

12. The apparatus of claim 1, wherein the channel is bifurcated along a portion of the second tube distal to the housing.

13. The apparatus of claim 12, wherein one of the bifurcated channels is configured to allow an inflow from the distal end to the cavity.

14. The apparatus of claim 1, comprising a diverter engaged with the distal end of the second tube, the diverter having at least two elongate diversion members extending from the distal end of the second tube, with each diversion member defining a diversion channel in communication with the channel defined by the second tube.

15. The apparatus of claim 14, wherein the diverter is configured to cooperate with the second tube to form a Y-arrangement or a T-arrangement.

16. The apparatus of claim 14, wherein each diversion member includes a proximal end engaged with the distal end of the second tube, and an opposing distal end, and wherein the second tube is configured to only allow flow of the aqueous humor outwardly of the distal end thereof from the cavity.

17. The apparatus of claim 16, wherein one of the diversion members is configured to allow an inflow from the distal end thereof, wherein the inflow into the one of the diversion members is used to flush out the diversion members, without the inflow entering the distal end of the channel defined by the second tube.

18. The apparatus of claim 1, wherein an external portion of the second tube is coated for increasing patient comfort.

19. The apparatus of claim 1, wherein at least a portion of the second tube is configured to extend through the conjunctival layer upon implantation of the apparatus, and the at least a portion of the second tube is coated with or is comprised of a porous cellular ingrowth material.

20. A method of manufacturing 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 external ocular surface of the eye under an eyelid, the method comprising:

engaging an outlet end of a first tube into fluid communication with a cavity defined by a housing, the first tube extending, along a first axis, between an inlet end and the outlet end, the inlet end adapted to be in fluid communication with the anterior chamber of the eye, the first tube being adapted to direct a flow of aqueous humor from the anterior chamber and through the inlet end and to the outlet end such that the aqueous humor is received by the cavity;

engaging a proximal end of a second tube with the housing, the second tube extending along a second axis, the second axis being perpendicular to the first axis of the first tube, the second tube having a distal end opposing the proximal end and defining a longitudinally-extending channel, the second tube having a proximal opening disposed at the proximal end and a distal opening disposed at the distal end, the proximal end of the second tube being disposed in the housing and the distal end being spaced from the housing, the channel being in fluid communication with the cavity and configured to receive, through the proximal opening, the aqueous humor from the cavity and to direct the aqueous humor through the distal opening to a drainage site disposed distally to the anterior chamber and to the housing; and

operably engaging a flow control device with the second tube, the flow control device being configured to control the flow of the aqueous humor from the cavity and through the distal opening to the drainage site.

21. The method of claim 20, wherein the flow control device defines a conduit in communication between the cavity and the drainage site, the conduit being dilatable in response to the intraocular pressure being above a preselected pressure, to increase the flow or to decrease resistance to the flow of the aqueous humor through the conduit to the drainage site and to reduce the intraocular pressure to no greater than the preselected pressure.

22. The method of claim 20, comprising disposing a filter device in fluid communication between the inlet end of the tube and the flow control device, the filter device being configured to filter contaminants from the aqueous humor prior to the flow control device.

23. The method of claim 22, wherein disposing a filter device in fluid communication between the inlet end of the first tube and the flow control device comprises engaging the filter device with the housing subsequent to the outlet end of the first tube, with the housing being configured such that the flow control device operably engaged therewith is removable or replaceable with respect to the housing, so as to allow the filter device to be removed or replaced.

24. The method of claim 20, comprising disposing a filter device in fluid communication between the flow control device and the distal end of the second tube, the filter device being configured to filter contaminants from any backflow to the flow control device from the drainage site.

25. The method of claim 24, wherein the filter device is configured to be removable or replaceable with respect to the second tube.

26. The method of claim 24, wherein the filter device is engaged with the second tube.

27. The method of claim 26, wherein the second tube and the filter device are configured to be removable or replaceable with respect to the housing, and such that the filter device is configured to be removable or replaceable with respect to the second tube.

28. The method of claim 20, comprising operably engaging an anchoring device with the first tube or the housing, the anchoring device being configured to engage the eye subconjunctivally so as to secure at least the first tube or the housing to the eye.

29. The method of claim 20, comprising wherein the second tube is configured to be collapsible on removal of the flow control device.

30. The method of claim 20, comprising applying a medicinal agent to the flow control device for preventing occlusion or bacterial contamination thereof by inhibiting the formation of fibrotic membranes, inflammatory membranes, bacterial adhesions, or biofilms.

31. The method of claim 20, wherein the channel defined by the second tube is bifurcated along a portion of the second tube distal to the housing.

32. The method of claim 31, wherein one of the bifurcated channels is configured to allow an inflow from the distal end to the cavity.

33. The method of claim 20, comprising engaging a diverter with the distal end of the second tube, the diverter having at least two elongate diversion members extending from the distal end of the second tube, with each diversion member defining a diversion channel in communication with the channel defined by the second tube.

34. The method of claim 33, wherein the diverter is configured to cooperate with the second tube to form a Y-arrangement or a T-arrangement.

35. The method of claim 33, wherein each diversion member includes a proximal end engaged with the distal end of the second tube, and an opposing distal end, and wherein the tubular member is configured to only allow flow of the aqueous humor outwardly of the distal end thereof from the cavity.

36. The method of claim 35, wherein one of the diversion members is configured to allow an inflow from the distal end thereof, wherein the inflow into the one of the diversion members is used to flush out the diversion members, without the inflow entering the distal end of the channel defined by the second tube.

37. The method of claim 20, comprising coating an external portion of the second tube for increasing patient comfort.

38. The method of claim 20, wherein at least a portion of the second tube is configured to extend through the conjunctival layer upon implantation of the apparatus, and the method comprises coating the at least a portion of the second tube with a porous cellular ingrowth material or forming the at least a portion of the second tube with the porous cellular ingrowth material.