Method and apparatus for reducing intraocular pressure

• US 20060189915A1
• Filed: 02/23/2005
• Published: 08/24/2006
• Est. Priority Date: 02/23/2005
• Status: Active Grant

• Current Assignee: Board of Regents of the University of Nebraska
• Original Assignee: Board of Regents of the University of Nebraska
• Inventors: Camras, Carl B., Camras, Lucinda J.
• Granted Patent: US 7,641,627 B2
• Time in Patent Office: Days
• US Class Current: 604/8
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

An intraocular drainage apparatus for treatment of glaucoma, a device to be used in the insertion of the drainage apparatus, and a method of controllably regulating intraocular pressure in glaucoma patients through the use of the drainage apparatus is described herein. The drainage apparatus is comprised of a tube capable of conducting fluid disposed between an inlet assembly, where aqueous humor enters the apparatus, and an outlet assembly, where aqueous humor exits the apparatus. The inlet assembly is comprised of a beveled tip and preferably an anchor. The beveled tip allows the drainage apparatus to be more easily inserted into an eyeball and the anchor, when employed, functions to hold the beveled tip of the inlet assembly within the anterior chamber of the eyeball. An opening in the beveled tip of the inlet assembly allows aqueous humor from the anterior chamber of the eyeball to flow through the inlet assembly, through the tube to ultimately drain through the outlet assembly, situated on the external surface of the eyeball, so as to be drained out of the eyeball onto the exterior surface of the eyeball. The inserting apparatus is comprised of an insertion prong attached to a first handle. The insertion prong has a sharp, beveled insertion point. The insertion prong also defines an aperture wherein a second prong is slideably received. The drainage apparatus is seated in the inserting apparatus and is positioned at a proper point in the eyeball. The inserting apparatus is then manipulated so that the second prong drives the drainage apparatus into the proper position within the eyeball. The drainage apparatus also provides for the use of micropore filters and/or valves to prevent infection and/or to predictably regulate the flow of aqueous humor from the anterior chamber of the eyeball to the surface of the eyeball, thereby allowing for post-surgical adjustment of the intraocular pressure within the eyeball. An apparatus for removing and replacing these filters and/or valves is also disclosed, as are alternative embodiments of the drainage apparatus and inserting apparatus.

Claims

1. An apparatus to reduce intraocular pressure in an eyeball, comprising:

an inlet assembly, a tube and an outlet assembly, said tube being disposed between said inlet assembly and said outlet assembly, wherein said outlet assembly is positioned at the external surface of the eyeball;

a flange adapted for securing said inlet assembly within the anterior chamber of the eyeball; and

means for controlling the flow of aqueous humor through said tube from said anterior chamber of the eyeball to said external surface of the eyeball, whereby said aqueous humor may flow from said anterior chamber of the eyeball to the external surface of the eyeball.

2. The apparatus of claim 1 wherein said outlet assembly comprises a member shaped to correspond to the external curvature of an eyeball and covers any point of ingress into the eyeball.

3. The apparatus of claim 1 wherein said outlet assembly comprises two members shaped to correspond to the external curvature of an eyeball held in relative proximity to each other and covers any point of ingress into the eyeball.

4. The apparatus of claim 1 wherein said means for controlling the flow of aqueous humor is contained within said outlet assembly.

5. The apparatus of claim 1 wherein said means for controlling the flow of aqueous humor comprises a replaceable filter.

6. The apparatus of claim 1 wherein said means for controlling the flow of aqueous humor comprises a replaceable valve.

7. The apparatus of claim 1 wherein said means for preventing infection comprises a replaceable filter.

8. The apparatus of claim 1 wherein said means of fixation of the outlet assembly would be to coat the posterior aspect of the inner member of the outlet assembly with hydroxyapatite or similar material. If the epithelium of the conjunctival layer underlying the outlet assembly is abraded, the conjunctiva will adhere to the hydroxyapatite on the posterior aspect of the inner member of the outlet assembly.

9. The apparatus of claim 1 wherein said means of replacing the outlet assembly including the replaceable filter and/or valve comprises the use of a plunger or similar suctioning device to the external surface of the outlet assembly.

10. An apparatus to reduce intraocular pressure within an eyeball, comprising:

a tube having an inlet assembly and an outlet assembly, said outlet assembly being positioned at the external surface of the eyeball;

a flange adapted for securing said inlet assembly within the anterior chamber of the eyeball; and

means for controlling the flow of aqueous humor through said tube from said anterior chamber of the eyeball to said external surface of the eyeball, whereby said aqueous humor may flow from said anterior chamber of the eyeball to the external surface of the eyeball.

11. The apparatus of claim 10 wherein said outlet assembly comprises a member shaped to correspond to the external curvature of an eyeball and covers any point of ingress into the eyeball.

12. The apparatus of claim 10 wherein said outlet assembly comprises two members shaped to correspond to the external curvature of an eyeball held in relative proximity to each other and covers any point of ingress into the eyeball.

13. The apparatus of claim 10 wherein said means for controlling the flow of aqueous humor is contained within said outlet assembly.

14. The apparatus of claim 10 wherein said means for controlling the flow of aqueous humor comprises a replaceable filter.

15. The apparatus of claim 10 wherein said means for controlling the flow of aqueous humor comprises a replaceable valve.

16. The apparatus of claim 10 wherein said means for preventing infection comprises a replaceable filter.

17. The apparatus of claim 10 wherein said means of fixation of the outlet assembly would be to coat the posterior aspect of the inner member of the outlet assembly with hydroxyapatite or similar material. If the epithelium of the conjunctival layer underlying the outlet assembly is abraded, the conjunctiva will adhere to the hydroxyapatite on the posterior aspect of the inner member of the outlet assembly.

18. The apparatus of claim 10 wherein said means of replacing the outlet assembly including the replaceable filter and/or valve comprises the use of a plunger or similar suctioning device to the external surface of the outlet assembly.

19. A surgical method to reduce intraocular pressure within an eyeball through the use of a drainage apparatus having an inlet assembly, an outlet assembly and a tube disposed between said inlet assembly and said outlet assembly, said device having means for controlling the flow of aqueous humor through said tube, comprising the steps of:

inserting said inlet assembly of said drainage apparatus into the anterior chamber of said eyeball;

securing said inlet assembly of said drainage apparatus within said anterior chamber of said eyeball;

securing said outlet assembly at the external surface of said eyeball, and

controlling the rate of aqueous humor flowing from said anterior chamber of said eyeball to said external surface of said eyeball.

20. The method of claim 19 wherein said means for controlling the amount of aqueous humor flowing from said anterior chamber comprises removing and replacing a filter.

21. The method of claim 19 wherein said means for controlling the amount of aqueous humor flowing from said anterior chamber comprises removing and replacing a valve.

22. A device for use to surgically implant a drainage apparatus in an eyeball comprising:

a first elongated member movably attached to a first handle, said first elongated member defining an aperture, wherein said first elongated member contains a sharpened end;

a second elongated member slideably received within said aperture of said first elongated member, said second elongated member movably attached to a second handle;

said first handle and said second handle being movably attached, such that movement of said second handle forcibly moves said second elongated member within said aperture of said first elongated member, whereby said second elongated member may push said drainage apparatus through the conjunctival layer of said eyeball into the anterior chamber of said eyeball.

23. An alternative device for use to surgically implant a drainage apparatus in an eyeball comprising:

a trocar having an incision end and secured within an outer cylinder at its opposite end;

the outer cylinder has an open end beyond which the incision end of the trocar extends;

the tube and inlet assembly of the drainage device are inserted over the trocar within the outer cylinder by inserting the incision end through the second end of the tube so that the incision end passes through the tube and protrudes slightly beyond the opening of the inlet assembly;

the insertion plate is positioned against the open end of the outer cylinder;

the inlet assembly, tube, outer cylinder and trocar are guided through a conjunctival incision and pushed beneath the conjunctival layer to the limbus;

the incision end of the trocar is pierced through the limbus with the outer cylinder pressing against the insertion plate to drive the beveled tip of the inlet assembly through the limbus into the anterior chamber of said eyeball.

24. A device for removing and replacing a filter in a drainage apparatus comprising:

a first elongated member having a terminal end;

second elongated member having a terminal end and being opposably attached to said first elongated member;

grasping means formed within said terminal end of said first elongated member and said terminal end of said second elongated member, whereby said first elongated member and said second elongated member are capable of being manipulated to grasp an object.

25. An apparatus for reducing intraocular pressure in an eyeball, comprising:

a tube, said tube having a first end and a second end;

an inlet assembly, said inlet assembly having a first end and a second end, said first end of said inlet assembly adapted for insertion into the anterior chamber of an eyeball, said second end of said inlet assembly attached to and in fluid communication with said first end of said tube;

a flange extending from said inlet assembly and adapted for securing said first end of said inlet assembly within said anterior chamber;

an outlet assembly attached to and in fluid communication with said second end of said tube, said outlet assembly positioned on the external surface of said eyeball; and

means for adjustably controlling the rate of flow of aqueous humor from said anterior chamber to said external surface of said eyeball.

26. The apparatus of claim 25, said outlet assembly comprising a first member shaped to generally correspond to the external curvature of said external surface of said eyeball, said first member covering the point of insertion of said first end of said inlet assembly into the conjunctival layer of said eyeball, a second member in spaced relation with said first member, said first and second members thereby defining a void through which aqueous humor may flow to said external surface of said eyeball.

27. The apparatus of claim 25, wherein said means for adjustably controlling the rate of flow of aqueous humor is contained within said outlet assembly.

28. The apparatus of claim 25, wherein said means for adjustably controlling the rate of flow of aqueous humor comprises a replaceable filter.

29. The apparatus of claim 25, wherein said means for adjustably controlling the rate of flow of aqueous humor comprises a replaceable valve.

30. The apparatus of claim 25, wherein said means for adjustably controlling the rate of flow of aqueous humor is adapted to be replaceable without removal of said first end of said inlet assembly from said anterior chamber of said eyeball.

31. The apparatus of claim 25, wherein said tube and said inlet assembly are formed as an integral unit.

32. A device for surgically implanting a drainage apparatus in an eyeball, comprising:

a first handle;

a second handle, said second handle pivotally attached to said first handle;

a first elongated member extending from said first handle, said first elongated member defining an aperture and further defining a slot adapted for receiving a drainage apparatus therein, said first elongated member comprising a sharpened end;

a second elongated member, said second elongated member slidably received within said aperture of said first elongated member and pivotally attached to said second handle, whereby movement of said second handle and said second elongated member towards said sharpened end of said first elongated member urges said drainage apparatus into the anterior chamber of said eyeball.

33. The device of claim 32, wherein said first elongated member is adapted to be inserted beneath the conjunctival layer of said eyeball.

34. The device of claim 33, wherein said sharpened end of said first elongated member is adapted to pierce the limbus of said eyeball.

35. A device for surgically implanting a drainage apparatus in an eyeball, comprising:

a handle;

an elongated member extending from said handle, said elongated member defining an aperture;

a trocar attached within said aperture of said elongated member and extending therefrom, said trocar comprising a sharpened end, wherein said trocar is adapted to be received within said drainage apparatus;

whereby said elongated member and said trocar may be manipulated to urge the drainage apparatus into the anterior chamber of said eyeball.

36. The device of claim 35, wherein said elongated member and said trocar are adapted to be inserted beneath the conjunctival layer of said eyeball.

37. The device of claim 36, wherein said sharpened end of said trocar is adapted to pierce the limbus of said eyeball.

38. A method for treating glaucoma, comprising:

Inserting a drainage apparatus into an eyeball, said drainage apparatus comprising a tube having a first end and a second end, an inlet assembly adapted for insertion into the anterior chamber of an eyeball and attached to and in fluid communication with said first end of said tube, said inlet assembly further comprising a flange extending therefrom, an outlet assembly attached to and in fluid communication with said second end of said tube, said outlet assembly positioned on the external surface of said eyeball and comprising means to adjustably control the rate of flow of aqueous humor through said drainage apparatus;

Securing said inlet assembly within said anterior chamber of said eyeball by positioning said flange against the corneal endothelium of said anterior chamber, whereby said aqueous humor from said anterior chamber flows through said drainage apparatus to said external surface of said eyeball;

Monitoring the intraocular pressure of said eyeball; and

Adjusting said means to adjustably control the rate of flow of aqueous humor to vary the rate of flow of said aqueous humor through said drainage apparatus, thereby varying the intraocular pressure in said eyeball.

39. The method of claim 38, wherein said flange is positioned against the angle of said eyeball.

40. The method of claim 38, wherein adjusting said means to adjustably control the rate of flow of aqueous humor comprises removing and replacing a valve.

41. The method of claim 38, wherein adjusting said means to adjustably control the rate of flow of aqueous humor comprises removing and replacing a filter.