Device for use in the eye

• US 6,186,974 B1
• Filed: 08/16/1999
• Issued: 02/13/2001
• Est. Priority Date: 01/10/1997
• Status: Expired due to Fees

• Current Assignee: Moorfields Eye Hospital NHS Foundation Trust, University College London Institute Of Ophthalmology
• Original Assignee: University College London and Moorfields Eye Hospital NHS Trust
• Inventors: Jones, Stephen Alister, Muir, Andrew Victor Graham, Allan, Bruce Duncan Samuel
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US09/341,442
• Time in Patent Office: 547 Days
• Field of Search: 604/8, 604/9, 604/264, 604/265, 604/294, 604/30, 604/31, 606/166, 606/108, 606/184, 606/185
• US Class Current: 604/30
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

A glaucoma filtration implant is constituted by a generally tubular body section having an oblong external diameter formed of a continuous convex curve. The device preferably has flow resistance structure provided by a portion of the internal lumen having a reduced diameter. The flow resistance structure may have a length of up to 5000 μm and a diameter in the range 15 to 50 μm, the diameter being selected so as to achieve a pressure drop along the flow resistance structure in the range 5 to 15 mm Hg. The internal conduit for liquid flow also may include a removable flow inhibitor, which can be removed after implantation by a laser, such as an ophthalmic YAG laser. The device is made of biocompatible materials.

Claims

1. A device for positioning in a slit aperture in the eye of a human or animal patient for relieving glaucoma, said device comprising:

an elongate body section having interior and exterior end sections at respective interior and exterior ends thereof;

at least one lumen extending through the body between the interior and exterior ends thereof;

wherein the exterior end section has a channel, one end of which has a mouth which opens to the outside of the eye and the other end of which is in fluid communication with at least one of said at least one lumen, and

wherein the interior end section has a passageway, one end of which has a mouth opening into an internal chamber of the eye and the other end of which is in fluid communication with at least one of said at least one lumen,

whereby the device has a conduit for fluid flowing from an internal chamber of the eye, which conduit extends through the passageway, the lumen and the channel and out to the outside of the eye, the body section being adapted for positioning in the slit aperture in the wall of the eye, the interior end section being adapted for being located so that it extends into an internal chamber of the eye and the exterior section being adapted for being located so that the mouth opens to the outside of the eye,

wherein the conduit includes a removable flow inhibitor which inhibits flow in the conduit,

wherein the body section has a cross section perpendicular to its axis which is the shape of an axial section through a bi-convex lens.

2. The device according to claim 1 in which said conduit includes a flow resistance element having a length λ

in μ

m, and a substantially circular cross section having diameter δ

μ

m meeting the following requirements;

3. A device according to claim 1 in which the flow inhibitor is ablatable by an ophthalmic laser.

4. A device according to claim 3 wherein the material of the flow inhibitor is semi-permeable such that the rate of flow of intraocular fluid through the flow inhibitor at a pressure difference of 15 mmHg is in the range 1.4 to 3 mμ

l/minute.

5. The device according to claim 1 in which the ratio of the greatest diameter to that of the smallest diameter of the external periphery of the body section is in range (3 to 1.2):

1.

6. A device according to claim 5, wherein said ratio is in the range (2.5 to 1.5):

1.

7. The device according to claim 1 in which the shape and dimensions of the external periphery are constant along the length of the body section.

8. A device according to claim 1 in which the body section, along at least a part of its length, is formed of an external layer at the external surface and at least one internal layer, in which the external layer is resilient and has relatively low hardness, whilst the internal layer is formed of a material having a higher hardness.

9. The device of claim 1 in which all the tissue contacting surfaces of the device are formed of a biocompatible material, preferably a polymeric material in which the polymer includes pendant zwitterionic groups.

10. A device according to claim 9, wherein said polymer includes quaternary ammonium/phosphate ester zwitterionic groups.

11. A device according to claim 1 which further including a flange at the interior and/or exterior end thereof.

12. A device according to claim 11 in which the body section is tapered inwards towards end having the said flange.

16. The device according to claim 1 in which said conduit includes a flow resistance element having a length λ

in μ

m, and a substantially circular cross section having diameter δ

μ

m meeting the following requirements;

17. The device according to claim 1 wherein the flow inhibitor is ablatable by an ophthalmic laser.

13. A method for regulating the flow of fluid from an internal chamber of the eye of a human or animal patient, said method comprising:

forming a fluid escape channel from the internal chamber as a slit,

inserting a device into the fluid escape channel such that a greatest diameter of the device is aligned with the slit, said device being for positioning in the slit for relieving glaucoma, said device comprising;

an elongate body section having interior and exterior end sections at respective interior and exterior ends thereof; and

at least one lumen extending through the body section between the interior and exterior ends thereof,

wherein the exterior end section has a further channel, one end of which has a mouth which opens to an outside of the device and the other end of which is in fluid communication with at least one of said at least one lumen, and

wherein the interior end section has a passageway one end of which has a mouth opening into an internal chamber of the device and the other end of which is in fluid communication with at least one of said at least one lumen,

whereby the device has a conduit for fluid flowing from an internal chamber of the eye, which conduit extends through the passageway, the lumen and the further channel, the body section being adapted for positioning in another channel in the wall of the eye, the interior end section being adapted for being located so that it extends into an internal chamber of the eye and the exterior end section being adapted for being located in use in a cavity,

wherein the body section has a cross section perpendicular to its axis the perimeter of which is oblong having a longer diameter and a shortest diameter and forms a continuous convex curve;

said method further comprising;

allowing fluid to flow from the internal chamber of the eye through a conduit of said device and out through an exterior end of the device into another cavity.

14. A method according to claim 13 in which the internal chamber of the eye is the anterior chamber and in which the device relieves raised intraocular pressure.

15. A method according to 13 in which the device includes an ablatable flow inhibitor means within a passageway and in which the method includes the step of ablating the flow inhibitor after implantation of the device.

18. A device for positioning in a slit aperture in the eye of a human or animal patient for relieving glaucoma, said device comprising:

an elongate body section having interior and exterior end sections at respective interior and exterior ends thereof;

at least one lumen extending through the body between the interior and exterior ends thereof;

wherein the exterior end section has a channel, one end of which has a mouth which opens to the outside of the eye and the other end of which is in fluid communication with at least one of said at least one lumen, and

wherein the interior end section has a passageway, one end of which has a mouth opening into an internal chamber of the eye and the other end of which is in fluid communication with at least one of said at least one lumen,

whereby the device has a conduit for fluid flowing from an internal chamber of the eye, which conduit extends through the passageway, the lumen and the channel and out to the outside of the eye, the body section being adapted for positioning in the slit aperture in the wall of the eye, the interior end section being adapted for being located so that it extends into an internal chamber of the eye and the exterior section being adapted for being located so that the mouth opens to the outside of the eye,

wherein the conduit includes a removable flow inhibitor which inhibits flow in the conduit,

wherein the body section has a cross section perpendicular to its axis the perimeter of which is oblong, having a longest diameter along a longitudinal axis thereof and a shortest diameter along a lateral axis thereof, the ratio of the longest diameter to the shortest diameter being in the range (1.5 to 2.5);

1, the cross section being symmetrical about both longitudinal and lateral axes, and having a perimeter formed, on each side of said longitudinal axis of an arc of a circle, the end points of the arcs being joined at rounded intersection points, having a radius of curvature less than 0.25 times the radius of curvature of said arcs.

19. The device according to claim 18 in which said conduit includes a flow resistance element having a length λ

in μ

m, and a substantially circular cross section having diameter δ

μ

m meeting the following requirements;

20. The device according to claim 18 wherein the flow inhibitor is ablatable by an ophthalmic laser.

21. A device for positioning in a slit aperture in the eye of a human or animal patient for relieving glaucoma, said device comprising:

an elongate body section having interior and exterior end sections at respective interior and exterior ends thereof;

at least one lumen extending through the body between the interior and exterior ends thereof;

wherein the exterior end section has a channel, one end of which has a mouth which opens to the outside of the eye and the other end of which is in fluid communication with at least one of said at least one lumen, and

wherein the interior end section has a passageway, one end of which has a mouth opening into an internal chamber of the eye and the other end of which is in fluid communication with at least one of said at least one lumen,

whereby the device has a conduit for fluid flowing from an internal chamber of the eye, which conduit extends through the passageway, the lumen and the channel and out to the outside of the eye, the body section being adapted for positioning in the slit aperture in the wall of the eye, the interior end section being adapted for being located so that it extends into an internal chamber of the eye and the exterior section being adapted for being located so that the mouth opens to the outside of the eye,

wherein the conduit includes a removable flow inhibitor which inhibits flow in the conduit,

wherein the body section has a cross section perpendicular to its axis the perimeter of which is oblong, having a longest diameter along a longitudinal axis thereof

inserting a device into the fluid escape channel such that the longitudinal axis of the body section cross section is aligned with the slit, said device being for positioning in the slit for relieving glaucoma, said device comprising;

an elongate body section having interior and exterior end sections at respective interior and exterior ends thereof;

at least one lumen extending through the body between the interior and exterior ends thereof;

wherein the exterior end section has a channel, one end of which has a mouth which opens to the outside of the eye and the other end of which is in fluid communication with at least one of said at least one lumen, and

wherein the interior end section has a passageway, one end of which has a mouth opening into an internal chamber of the eye and the other end of which is in fluid communication with at least one of said at least one lumen,

whereby the device has a conduit for fluid flowing from an internal chamber of the eye, which conduit extends through the passageway, the lumen and the further channel and out to the outside of the eye, the body section being adapted for positioning in the slit aperture in the wall of the eye, the interior end section being adapted for being located so that it extends into an internal chamber of the eye and the exterior section being adapted for being located so that the mouth opens to the outside of the eye,

wherein the conduit includes a removable flow inhibitor which inhibits flow in the conduit, and a shortest diameter along a lateral axis thereof, the ratio of the longest diameter to the shortest diameter being in the range (1.5 to 2.5);

1, the perimeter of the cross section being formed of convex curves on each side of said longitudinal axis, and extending from said lateral axis towards the end, and further comprising straight sections extending from the convex curve towards each end forming an angle to said longitudinal axis of less than 30°

.

22. The device according to claim 21 in which said conduit includes a flow resistance element having a length λ

in μ

m, and a substantially circular cross section having diameter δ

μ

m meeting the following requirements;

23. The device according to claim 21 wherein the flow inhibitor is ablatable by an ophthalmic laser.

24. A device according to claim 23 wherein the body section has one or more straight sections each forming an angle in the range of 15°

to 30°

to the longitudinal axis.

25. A device according to claim 21 in which the straight sections extend to and join together at the longitudinal axis.

26. A device according to claim 21 in which the convex curves each form the arc of a circle having a radius, and in which said straight sections are connected via rounded intersections having radii of curvature less than 0.25 times the radius of said arc.

27. A method for regulating the flow of fluid from an internal chamber of the eye of a human or animal patient, said method comprising:

forming a fluid escape channel from the internal chamber as a slit,

wherein the body section has a cross section perpendicular to its axis which is the shape of an axial section through a bi-convex lens;

said method further comprising;

allowing fluid to flow from the internal chamber of the eye through a conduit of said device and out through a conduit of said device and out through an exterior end of the device to the outside of the eye.

28. A method according to claim 27 wherein the internal chamber of the eye is the anterior chamber and wherein the device relieves raised intraocular pressure.

29. A method according to claim 27 wherein said flow inhibitor means is ablatable and wherein said method includes ablating the ablatable flow inhibitor after implantation of the device.

30. A method for regulating the flow of fluid from an internal chamber of the eye of a human or animal patient, said method comprising:

forming a fluid escape channel from the internal chamber as a slit,

inserting a device into the channel such that the longitudinal axis of the body section cross section is aligned with the slit, said device being for positioning in the slit for relieving glaucoma, said device comprising;

an elongate body section having interior and exterior end sections at respective interior and exterior ends thereof;

at least one lumen extending through the body between the interior and exterior ends thereof;

wherein the exterior end section has a further channel, one end of which has a mouth which opens to the outside of the eye and the other end of which is in fluid communication with at least one of said at least one lumen, and

wherein the interior end section has a passageway, one end of which has a mouth opening into an internal chamber of the eye and the other end of which is in fluid communication with at least one of said at least one lumen,

whereby the device has a conduit for fluid flowing from an internal chamber of the eye, which conduit extends through the passageway, the lumen and the further channel and out to the outside of the eye, the body section being adapted for positioning in the slit aperture in the wall of the eye, the interior end section being adapted for being located so that it extends into an internal chamber of the eye and the exterior section being adapted for being located so that the mouth opens to the outside of the eye,

wherein the conduit includes a removable flow inhibitor which inhibits flow in the conduit,

wherein the body section has a cross section perpendicular to its axis the perimeter of which is oblong, having a longest diameter along a longitudinal axis thereof and a shortest diameter along a lateral axis thereof, the ratio of the longest diameter to the shortest diameter being in the range (1.5 to 2.5);

1, the cross section being symmetrical about both longitudinal and lateral axes, and having a perimeter formed, on each side of said longitudinal axis of an arc of a circle, the end points of the arcs being joined at rounded intersection points, having a radius of curvature less than 0.25 times the radius of curvature of said arcs;

said method further comprising;

allowing fluid to flow from the internal chamber of the eye through a conduit of said device and out through a conduit of said device and out through an exterior end of the device to the outside of the eye.

31. A method according to claim 30 wherein the internal chamber of the eye is the anterior chamber and wherein the device relieves raised intraocular pressure.

32. A method according to claim 30 wherein said flow inhibitor means is ablatable and wherein said method includes ablating the ablatable flow inhibitor after implantation of the device.

33. A method for regulating the flow of fluid from an internal chamber of the eye of a human or animal patient, said method comprising:

forming a fluid escape channel from the internal chamber as a slit,

inserting a device into the channel such that the longitudinal axis of the body section cross section is aligned with the slit, said device being for positioning in the slit for relieving glaucoma, said device comprising;

an elongate body section having interior and exterior end sections at respective interior and exterior ends thereof;

at least one lumen extending through the body between the interior and exterior ends thereof;

wherein the exterior end section has a further channel, one end of which has a mouth which opens to the outside of the eye and the other end of which is in fluid communication with at least one of said at least one lumen, and

wherein the interior end section has a passageway, one end of which has a mouth opening into an internal chamber of the eye and the other end of which is in fluid communication with at least one of said at least one lumen,

whereby the device has a conduit for fluid flowing from an internal chamber of the eye, which conduit extends through the passageway, the lumen and the further channel and out to the outside of the eye, the body section being adapted for positioning in the slit aperture in the wall of the eye, the interior end section being adapted for being located so that it extends into an internal chamber of the eye and the exterior section being adapted for being located so that the mouth opens to the outside of the eye,

wherein the conduit includes a removable flow inhibitor which inhibits flow in the conduit,

wherein the body section has a cross section perpendicular to its axis the perimeter of which is oblong, having a longest diameter along a longitudinal axis thereof and a shortest diameter along a lateral axis thereof, the ratio of the longest diameter to the shortest diameter being in the range (1.5 to 2.5);

1, the perimeter of the cross section being formed of convex curves on each side of said longitudinal axis, and extending from said lateral axis towards the end, and further comprising straight sections extending from the convex curve towards each end forming an angle to said longitudinal axis of less than 30°

;

said method further comprising;

allowing fluid to flow from the internal chamber of the eye through a conduit of said device and out through a conduit of said device and out through an exterior end of the device to the outside of the eye.

34. A method according to claim 33 wherein the internal chamber of the eye is the anterior chamber and wherein the device relieves raised intraocular pressure.

35. A method according to claim 33 wherein said flow inhibitor means is ablatable and wherein said method includes ablating the ablatable flow inhibitor after implantation of the device.