System and methods for reducing intraocular pressure

• US 20030212383A1
• Filed: 12/27/2002
• Published: 11/13/2003
• Est. Priority Date: 01/05/2001
• Status: Abandoned Application

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Mulhern, Margaret, Pierce, Robert, Cote, Dana, Stoy, Vladimir, Wandel, Thaddeus
• Application Number:
  US10/182,833
• Publication Number:
  US 20030212383A1
• Time in Patent Office: Days
• US Class Current: 604/523
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61M 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202

Abstract

The present invention provides systems and methods for reducing intraocular pressure, thereby to treat glaucoma and other disorders. The systems of the present invention include a shunt insertable across the clear cornea and a delivery device for inserting the shunt in the transcorneal position. The shunt has a body with a head at one end and a foot at the opposite end, and a channel therethrough permitting the passage of aqueous humor from the anterior chamber to the external surface of the cornea. A removable filter is positioned within the channel to regulate aqueous humor outflow and to resist the incursion of microorganisms.

Claims

1. A shunt insertable through a clear cornea of an eye into an anterior chamber thereof, comprising:

a substantially cylindrical body having a channel extending from a proximal end to a distal end of the body for draining aqueous humor from the anterior chamber to an outer surface of the clear cornea;

a head positioned at the distal end of the body for engagement against the outer surface of the clear cornea, the head having an opening therethrough in fluid communication with the channel so as to permit egress of aqueous humor and to minimize ingress of microorganisms;

a foot positioned at the proximal end of the body for engagement against an inner surface of the cornea, the foot having an aperture therethrough in fluid communication with the channel so as to permit inflow of aqueous humor into the channel; and

an elongate filter retainable within the channel for regulating a flow rate of aqueous humor through the channel and for further minimizing the ingress of microorganisms.

2. The shunt of claim 1, wherein at least one of said head and said foot are formed integrally with said body.

3. The shunt of claim 1, wherein at least one of said head, said foot and said body comprise a dehydratable polymer.

4. The shunt of claim 1, wherein said shunt includes a dehydratable polymer whereby dehydration of said shunt reduces the size of said shunt for implantation through a small incision in the cornea and hydration of said shunt provides for said shunt to fit securely in said cornea.

5. The shunt of claim 1, wherein said elongate filter is removable from the channel.

6. The shunt of claim 1, wherein the body comprises a hydrogel.

7. The shunt of claim 6, wherein the hydrogel is covalently crosslinked and is based on a methacrylic acid derivative.

8. The shunt of claim 1, wherein at least one of an external surface of the head and an external surface of the foot are configured to minimize cellular adhesion.

9. The shunt of claim 1, wherein an external surface of the body is configured to encourage tissue adhesion.

10. The shunt of claim 1, wherein the foot is tapered to facilitate insertion of the corneal shunt through the cornea.

11. The shunt of claim 1, wherein the foot is dimensionally alterable from a first configuration to a second configuration to facilitate insertion of the corneal shunt through the cornea.

12. The shunt of claim 1, wherein the elongate filter is retainable within the channel by impaction.

13. The shunt of claim 1, wherein the elongate filter is retainable proximally within the channel.

14. An implant for transcorneal placement to drain an anterior chamber of an eye, comprising:

a head adapted for resting upon an external aspect of a cornea having a slit to permit egress of aqueous humor while resisting ingress of microorganisms and having an exterior surface resistant to cell adhesion;

a foot adapted for insertion across the cornea into the anterior chamber and further adapted to abut an internal aspect of the cornea atraumatically, having an aperture to permit outflow of aqueous humor therethrough;

a tubular conduit between the foot and the head having an interior channel in fluid communication with the aperture and the slit and having an external surface resistant to cell adhesion; and

an elongate filter dimensionally adapted for retention within the interior channel and provided with filtration pores to regulate rate of outflow of aqueous humor and to restrict the incursion of microorganisms.

15. A system for reducing intraocular pressure, comprising:

a transcorneal shunt to drain aqueous humor from an anterior chamber to an external surface of a cornea; and

a delivery device for implanting the shunt transcorneally, comprising

an insertion tip dimensionally adapted for releasably holding the shunt and for positioning the shunt for insertion through the external surface, and

an inserter slidable from a first position to a second position, wherein sliding said inserter from the first position to the second position dislodges the shunt from the insertion tip and urges the shunt through the external surface into a transcorneal position;

wherein the drainage of the aqueous humor from the anterior chamber to the external surface of the cornea by the shunt reduces intraocular pressure.

16. The system of claim 15, wherein the transcorneal shunt has an elongate tubular body, a head, a foot, and a filter, said body having a channel extending from one end to an opposite end for draining aqueous fluid therethrough, said head being positioned at the one end of the body for engagement against the external surface and having a slit in communication with the channel to permit egress of aqueous humor onto the external surface and to restrict ingress of microorganisms, said foot being positioned at the opposite end of the body for engagement against an internal surface of the cornea and having an aperture in communication with the channel to permit introduction of aqueous humor therein, and a filter retainable within the channel for regulating a flow rate of aqueous humor therethrough and for further restricting ingress of microorganisms.

17. The system of claim 15, wherein the inserter comprises a slidable tip piece movable from anterior to posterior, and wherein the delivery device further comprises a fixed plunger coaxial with the slidable tip piece.

18. The system of claim 15, wherein the delivery system further comprises a fixed distal tip piece, and wherein the inserter comprises a slidable plunger coaxial with the fixed distal tip piece and movable from posterior to anterior.

19. A method for decreasing anterior chamber fluid pressure, comprising:

providing a shunt to drain aqueous humor from an anterior chamber to an external surface of the cornea;

providing a delivery device having a tip dimensionally adapted for releasably retaining the shunt and for positioning the shunt for insertion through the external surface and having an inserter that displaces the shunt from the tip and urges the shunt through the external surface into a transcorneal position; and

employing the delivery device to insert the shunt across the cornea into the transcorneal position, whereby aqueous humor can flow from the anterior chamber to the external surface, thereby decreasing anterior chamber fluid pressure.

20. The method of claim 19, wherein the shunt has an elongate tubular body, a head, a foot, and a filter, said body having a channel extending from one end to an opposite end for draining aqueous fluid therethrough, said foot being positioned at the one end of the body for engagement against an internal surface of the cornea and having an aperture in communication with the channel to permit introduction of aqueous humor therein, said head being positioned at the opposite end of the body, being adapted for abutting the external surface and having a slit in communication with the channel to permit egress of aqueous humor onto the external surface, and said filter retainable within the channel for regulating a flow rate of aqueous humor therethrough and for further restricting ingress of microorganisms.

21. The method of claim 19, further comprising creating a pilot hole through the external surface to permit the insertion of the shunt therethrough.

22. The method of claim 19, further comprising removing the shunt after a preselected period of time.

23. The method of claim 22, wherein said preselected period of time is less than one month following surgery.

24. The method of claim 22, wherein said preselected period of time is at least one month.

25. The method of claim 22, wherein said preselected period of time is at least two hours following surgery.

26. A transcorneal implant spanning a cornea between a tear film on an external aspect of the cornea and an anterior chamber of an eye, comprising:

a head protruding from the cornea and having an outer surface in contact with the tear film and in contact at least intermittently with an eyelid, said outer surface being wettable with tears, highly hydrated and resistant to cell adherence;

a body comprising a hydrogel and having an external surface contacting stromal tissue of the cornea, said external surface being less hydrated than said outer surface of said head and facilitating cell adherence; and

a foot protruding into the anterior chamber.

27. The implant of claim 26, wherein the body is penetrated by an internal cavity having an internal surface.

28. The implant of claim 27, wherein the internal cavity includes a channel connecting the anterior chamber with the tear film.

29. The implant of claim 28, wherein the channel contains a filter that obstructs passage of microorganisms.

30. A method for manufacturing a corneal implant comprising casting a mixture comprising HEMA, methacrylic acid, dimethacrylate crosslinker, and a free radical initiator into a single part silicone mold with a cavity formed by imprinting with a die shaped in a preselected shape.

31. A method for manufacturing a corneal implant comprising machining a shunt and applying a tissue integration layer to an outer surface of the shunt, said tissue integration layer comprising a curable composition comprising a copolymer of HEMA with alkylmethacrylate, monomer HEMA, a dimethacrylate crosslinker, a free radical initiator and a volatile solvent.