Apparatus and method for reducing intraocular pressure

• US 10,342,702 B2
• Filed: 08/14/2015
• Issued: 07/09/2019
• Est. Priority Date: 08/29/2014
• Status: Active Grant

• Current Assignee: Alievio, Inc.
• Original Assignee: Camras Vision Inc.
• Inventors: Camras, Lucinda, Ypma, Rolf Erik
• Primary Examiner(s): Deak, Leslie R
• Application Number:
  US14/826,866
• Publication Number:
  US 20160058616A1
• Time in Patent Office: 1,425 Days
• Field of Search: 604 7- 10, 604264, 604 30, 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 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

An apparatus for reducing/stabilizing 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 flow control device is operably engaged with the housing, and is configured to control the flow of the aqueous humor, via a conduit defined thereby and extending from the cavity, to a location away from the anterior chamber. The conduit is dilatable in response to the intraocular pressure being above a preselected pressure, to increase the flow or to decrease resistance to 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. Associated apparatuses and methods are also provided.

Claims

1. An apparatus for draining aqueous humor from an eye for reducing or stabilizing 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 tube extending 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 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 tube, the cavity being configured to receive the aqueous humor; and

a flow control device operably engaged with the housing and configured to control the flow of the aqueous humor from the cavity to a location external to the anterior chamber, the flow control device including at least one conduit extending between the cavity and the external location, the at least one conduit configured to allow the flow of the aqueous humor from the cavity to the external location, an elongate portion of the at least one conduit formed from a flexible material configured to provide varying flow resistance as the aqueous humor continues to flow through the at least one conduit from the cavity to the external location, the flexible material defining a transverse cross-sectional area for the elongate portion of the at least one conduit,

wherein in response to each of various increases in the intraocular pressure, the flexible material is configured to expand to respectively increase the transverse cross-sectional area along the elongate portion of the at least one conduit, the flow resistance decreasing as the cross-sectional area increases, and

in response to each of various decreases in the intraocular pressure, the flexible material is configured to contract to respectively decrease the transverse cross-sectional area along the elongate portion of the at least one conduit, the flow resistance increasing as the cross-sectional area decreases.

2. The apparatus of claim 1, comprising a filter device disposed 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.

3. The apparatus of claim 2, wherein the filter device is engaged with the housing subsequent to the outlet end of the 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.

4. The apparatus of claim 1, comprising a filter device disposed in fluid communication with the flow control device, opposite to the outlet end of the tube from the flow control device, the filter device being configured to filter contaminants from any backflow to the flow control device.

5. The apparatus of claim 4, wherein the filter device is engaged with the housing subsequent to the flow control device, and wherein the housing is configured such that the filter device engaged therewith is removable or replaceable with respect to the housing.

6. The apparatus of claim 1, wherein the flow control device includes at least one additional conduit extending between the cavity and the external location.

7. The apparatus of claim 6, wherein the conduits are arranged in parallel.

8. The apparatus of claim 1, wherein the at least one conduit comprises a single inlet port in fluid communication with the cavity defined by the housing, and a plurality of outlet ports each in fluid communication with the inlet port through respective channels extending from the inlet port.

9. The apparatus of claim 8, wherein the channels extend radially outward from the single inlet port such that the outlet ports are angularly spaced apart about the inlet port.

10. The apparatus of claim 1, wherein the flow control device includes a first portion defining a single inlet port in fluid communication with the cavity defined by the housing, and a second portion defining a plurality of outlet ports, the first and second portions being configured to be complementarily engaged so as to define a reservoir therebetween, with the outlet ports each being in fluid communication with the inlet port via the reservoir.

11. The apparatus of claim 10, wherein the second portion is rigid so as to resist deformation in response to a force applied thereto.

12. The apparatus of claim 1, wherein the flow control device is configured to be responsive to an output of a laser device so as to form at least one additional conduit therein.

13. The apparatus of claim 1, wherein the flow control device is configured to be responsive to an output of a laser device to seal the at least one conduit.

14. The apparatus of claim 1, wherein the housing is configured such that the flow control device operably engaged therewith is removable or replaceable with respect to the housing.

15. The apparatus of claim 1, wherein the flow control device is disposed within the cavity defined by the housing.

16. The apparatus of claim 15, wherein the housing defines an aperture opposite the flow control device from the outlet end of the tube, the aperture being in fluid communication with the cavity so as to permit egress of aqueous humor therethrough to the external location.

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

18. The apparatus of claim 1, wherein the at least one conduit is configured to be normally constricted to prevent flow of the aqueous humor therethrough.

19. The article of claim 1, wherein the flow control device is comprised of a biocompatible material.

20. The article of claim 1, wherein the flexible material forming the at least one conduit includes of polyurethane or silicone.

21. A method of manufacturing an apparatus for draining aqueous humor from an eye for reducing or stabilizing 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 tube into fluid communication with a cavity defined by a housing, the outlet end extending to an inlet end adapted to be in fluid communication with the anterior chamber of the eye, the 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; and

engaging a flow control device with the housing, the flow control device being adapted to control the flow of the aqueous humor from the cavity to a location external to the anterior chamber, and including at least one conduit extending between the cavity and the external location, the at least one conduit configured to allow the flow of the aqueous humor from the cavity to the external location, an elongate portion of the at least one conduit formed from a flexible material configured to provide varying flow resistance as the aqueous humor continues to flow through the at least one conduit from the cavity to the external location, the flexible material defining a transverse cross-sectional area for the elongate portion of the at least one conduit,

wherein in response to each of various increases in the intraocular pressure, the flexible material is configured to expand to respectively increase the transverse cross-sectional area along the elongate portion of the at least one conduit, the flow resistance decreasing as the cross-sectional area increases, and

in response to each of various decreases in the intraocular pressure, the flexible material is configured to contract to respectively decrease the transverse cross-sectional area along the elongate portion of the at least one conduit, the flow resistance increasing as the cross-sectional area decreases.

22. The method of claim 21, comprising disposing a filter device into fluid communication between the inlet end of the tube and the flow control device, for filtering contaminants from the aqueous humor prior to the flow control device.

23. The method of claim 22, comprising engaging the filter device with the housing subsequent to the outlet end of the tube, such that the flow control device 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 21, comprising engaging a filter device into fluid communication with the flow control device, opposite to the outlet end of the tube from the flow control device, for filtering contaminants from any backflow to the flow control device.

25. The method of claim 24, comprising engaging the filter device with the housing subsequent to the flow control device, such that the filter device engaged therewith is removable or replaceable with respect to the housing.

26. The method of claim 21, wherein the flow control device includes at least one additional conduit extending between the cavity and the external location.

27. The method of claim 26, wherein the conduits are arranged in parallel.

28. The method of claim 21, wherein engaging a flow control device with the housing comprises engaging a flow control device with the housing, wherein the at least one conduit comprises a single inlet port in fluid communication with the cavity defined by the housing, and a plurality of outlet ports each in fluid communication with the inlet port through respective channels extending from the inlet port.

29. The method of claim 28, wherein engaging a flow control device with the housing comprises engaging a flow control device with the housing, wherein the channels extend radially outward from the single inlet port such that the outlet ports are angularly spaced apart about the inlet port.

30. The method of claim 21, wherein the flow control device includes a first portion defining a single inlet port in fluid communication with the cavity defined by the housing, and a complementarily-configured second portion defining a plurality of outlet ports, and wherein the method comprises engaging the first and second portions to define a reservoir therebetween, and such that the outlet ports are each in fluid communication with the inlet port via the reservoir.

31. The method of claim 21, comprising engaging the flow control device with an output of a laser device so as to form at least one additional conduit in the flow control device.

32. The method of claim 21, comprising engaging the flow control device with an output of a laser device so as to seal the at least one conduit.

33. The method of claim 21, wherein engaging a flow control device with the housing comprises inserting a flow control device into the cavity defined by the housing.

34. An apparatus for draining aqueous humor from an eye for reducing or stabilizing 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 tube extending 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 tube being adapted to direct a flow of aqueous humor from the anterior chamber and through the inlet end to the outlet end;

a flow control device operably engaged with the outlet end and configured to control the flow of the aqueous humor from the tube to a location external to the anterior chamber, the flow control device including at least one conduit extending between the outlet end and the external location, the at least one conduit configured to allow the flow of the aqueous humor from the cavity to the external location, an elongate portion of the at least one conduit formed from a flexible material configured to provide varying flow resistance as the aqueous humor continues to flow through the at least one conduit from the cavity to the external location, the flexible material defining a transverse cross-sectional area for the elongate portion of the at least one conduit,

wherein in response to each of various increases in the intraocular pressure, the flexible material is configured to expand to respectively increase the transverse cross-sectional area along the elongate portion of the at least one conduit, the flow resistance decreasing as the cross-sectional area increases, and

in response to each of various decreases in the intraocular pressure, the flexible material is configured to contract to respectively decrease the transverse cross-sectional area along the elongate portion of the at least one conduit, the flow resistance increasing as the cross-sectional area decreases;

a first filter device disposed in fluid communication between the inlet end of the tube and the flow control device, the first filter device being configured to filter contaminants from the aqueous humor prior to the flow control device; and

a second filter device disposed in fluid communication with the flow control device, opposite to the outlet end of the tube from the flow control device, the second filter device being configured to filter contaminants from any backflow to the flow control device.

35. The apparatus of claim 34, wherein the first filter device is engaged with the outlet end of the tube, and wherein the flow control device is operably engaged with the first filter device such that the flow control device is removable or replaceable with respect thereto, so as to allow the first filter device to be removed or replaced.

36. The apparatus of claim 34, wherein the second filter device is engaged with the flow control device opposite to the first filter device, and wherein the flow control device is configured such that the second filter device is removable or replaceable with respect thereto, so as to allow the second filter device to be removed or replaced.

37. The apparatus of claim 34, further comprising a housing defining a cavity in fluid communication with the outlet end of the tube, the cavity being configured to receive the aqueous humor, and the housing being configured to operably engage the flow control device such that the flow control device regulates the flow of the aqueous humor from the cavity.