Device for treating glaucoma & method of manufacture

• US 20040215126A1
• Filed: 04/22/2003
• Published: 10/28/2004
• Est. Priority Date: 04/22/2003
• Status: Active Grant

• Current Assignee: Ahmed A. Mateen
• Original Assignee: Ahmed A. Mateen
• Inventors: Ahmed, A. Mateen
• Granted Patent: US 7,025,740 B2
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

A device implanted in an eye of a patient suffering from glaucoma includes a valve seated in a pocket of a plate. The pocket includes a flexible, resilient top wall forming at least a portion of a topside surface of the plate. A channel in communication with an outlet of the valve has a open top that allows aqueous humor flowing from the outlet of the valve to flow onto the topside surface of the plate.

Claims

1. A device for treating glaucoma comprising

a one way valve that opens and closes in response to intraocular pressure within an eye of a patient suffering from glaucoma, said valve including

a valve body having a first end through which flows aqueous humor from an eye of a patient suffering from glaucoma upon implantation of the device into the eye, and

a second end opposed to the first end of the valve body to which one end of an inlet tube is attached,

said inlet tube having a free end opposed to said one end of the inlet tube, said free end being adapted to be inserted into an intraocular chamber of a patient suffering from glaucoma to enable the aqueous humor to flow from the intraocular chamber when the pressure with the intraocular chamber is at a predetermined level, and

a distribution plate made of a flexible, resilient material and having a first end, a second end opposed to the first end, a substantially concave substantially smooth underside surface, a substantially convex topside surface,

said plate including a pocket molded therein near the first end of the plate in which the valve is seated with the first end of the valve facing inward towards the second end of the plate,

said pocket including a top wall forming at least a portion of the convex topside surface of the plate, said top wall having a first opening therein near the first end of the plate that provides access to enable the valve to be inserted into the pocket by manipulation of the top wall,

a recess at the first end of the plate adjacent the first opening into which a section of the first end of the inlet tube is seated upon insertion of the valve into the pocket, and

a second opening inward of the first opening that allows aqueous humor flowing from the first end of the valve to flow through the second opening onto the topside surface.

2. The device of claim 1 where said device has a substantially ovoid configuration.

3. The device of claim 1 where said flexible, resilient material is siliconized rubber.

4. The device of claim 1 where said plate has a thickness of less than 0.07 inch.

5. The device of claim 1 where said topside surface has thereon at least two raised radial reinforcing members.

6. The device of claim 5 where said reinforcing members straddle the second opening.

7. The device of claim 5 where said topside surface is substantially smooth except for the reinforcing members.

8. The device of claim 1 including at least one drainage hole extending through the plate to allow the aqueous humor to flow over at least a portion of the topside surface through said hole to the underside surface.

9. The device of claim 1 where the valve and the pocket each have substantially the same configuration so the valve fits snug within the pocket.

10. The device of claim 1 where the device has a longitudinal axis and the first and second openings are positioned along said axis.

11. The device of claim 10 where the pocket has a channel extending therefrom inward towards the second end of the plate with the first opening overlying a central section of the pocket and the second opening overlying the channel, said first and second openings being connected to form a unitary, elongated aperture in said topside surface.

12. The device of claim 1 where the device includes at least one orifice therein that enables the device to be sutured to the eye.

13. The device of claim 1 where the valve includes within the body an elastic membrane having overlying sections that form a normally closed slit in the first end of the valve from which the aqueous humor flows upon opening the slit.

14. A device for treating glaucoma comprising

a one way valve that opens and closes in response to intraocular pressure within an eye of a patient suffering from glaucoma,

said valve including an inlet tube having a one end attached to the valve and a free end adapted to be inserted into an intraocular chamber the eye to allow aqueous humor from the intraocular chamber to flow into the free end and through the valve when the intraocular pressure exceeds a predetermined level,

a plate including a pocket with a channel extending therefrom, said pocket and valve having substantially the same configurations so the valve fits snug within the pocket,

said pocket including a flexible, resilient top wall forming at least a portion of a topside surface of the plate, said top wall having an opening therein that enables the valve to be inserted into the pocket,

said channel having a open top that allows aqueous humor flowing from the valve to flow onto the topside surface of the plate.

15. The device of claim 14 including a recess at an end of the plate into which a section of the one end of the inlet tube is seated snugly upon insertion of the valve into the pocket.

16. The device of claim 14 where the topside surface is substantially concave and substantially smooth, and the plate includes an underside surface that is substantially convex and substantially smooth.

17. The device of claim 14 where said device has a substantially ovoid configuration.

18. The device of claim 14 where said topside surface has thereon at least two raised radial reinforcing members.

19. The device of claim 18 where said reinforcing members straddle the open top of the channel.

20. The device of claim 18 including at least one drainage hole extending through the plate to allow the aqueous humor to flow over at least a portion of the topside surface through said hole to an underside surface.

21. The device of claim 14 where the opening in the top wall and the open top of the channel form a unitary, elongated aperture in said topside surface.

22. A device for treating glaucoma comprising

a one way valve including an inlet and outlet,

a body including plate and within the body a pocket in which the valve is seated,

a channel in the body in communication with the outlet of the valve,

said pocket including a flexible, resilient top wall forming at least a portion of a topside surface of the plate, said top wall having an opening therein that enables the valve to be inserted into the pocket,

said channel having an open top that allows aqueous humor flowing from the outlet of the valve to flow onto the topside surface of the plate,

said opening in the top wall and the open top of the channel forming a unitary, elongated aperture in said topside surface.

23. The device of claim 22 where the body has a longitudinal axis and is molded from a flexible, resilient material and the aperture extends lengthwise along said axis.

24. The device of claim 23 where the pocket and valve have substantially the same configurations so the valve fits snug within the pocket.

25. The device of claim 23 where said flexible, resilient material is siliconized rubber.

26. The device of claim 23 where said device has a substantially ovoid configuration.

27. The device of claim 23 where said body has a thickness less than 0.07 inch and a surface area of at least 0.25 square inches to provide an excess portion that may be trimmed off to reduce the size of the device as desired.

28. The device of claim 22 where said topside surface has thereon at least two raised radial reinforcing members that straddle the aperture.

30. The device of claim 28 including at least one drainage hole extending through the plate to allow the aqueous humor to flow over at least a portion of the topside surface through said drainage hole to the underside surface.

31. The device of claim 30 where reinforcing members each have inner ends and outer ends, said inner ends being closer to each other than the outer ends to create a reverse venturi effect to restrict flow of fluid from the outlet of the valve to thereby assist in creating a pool of fluid that trends to at least partially drain through the drainage hole.

32. A method of manufacturing a medical device that includes a valve placed in a pocket in a body of the device, said valve having a predetermined overall configuration and said body having a predetermined overall configuration of greater volume than the valve, said method comprising

providing a first mold having a cavity therein having a configuration substantially the same as the overall configuration of the body,

providing a second mold adapted to be inserted into the cavity in the first mold to thereby provide a space between the assembled first and second molds, said second mold including an upright element and a tongue attached thereto having a predetermined configuration substantially the same as the configuration of the valve,

inserting the second mold into the cavity in the first mold with the upright element projecting outward from the cavity to facilitate removal of the second mold from the first mold after formation of the body, said removal of the second mold forming an opening providing access to an interior of the pocket to enable the valve to be placed within the pocket,

injecting a molten plastic into the space between the assembled first and second molds with the tongue forming the pocket in the body and upright element forming the opening in the pocket, said molten plastic upon solidification being resilient,

after solidification of the plastic, separating the first and second molds, and

placing the valve in the pocket by inserting said valve through the opening.

33. The method of claim 32 where the pocket has a predetermined configuration that is deformed as the valve is placed therein and, due to the resiliency of the plastic, the pocket is restored to said predetermined configuration when the valve is placed therein.

34. The method of claim 32 where the tongue has a substantially trapezoidal shaped.

35. The method of claim 32 where the upright element is at a right angle to the tongue