Surgically implantable device for glaucoma relief

• US 5,300,020 A
• Filed: 09/30/1992
• Issued: 04/05/1994
• Est. Priority Date: 05/31/1991
• Status: Expired due to Term

• Current Assignee: L'Esperance Medical Technologies Incorporated
• Original Assignee: MedFlex LLC
• Inventors: L'Esperance, Francis A. Jr.
• Primary Examiner(s): KRUTER, JEROME
• Application Number:
  US07/954,653
• Time in Patent Office: 552 Days
• Field of Search: 604/8, 604/9, 604/175, 604/264, 623/4
• 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

The invention contemplates a surgically implantable device for controlled drainage flow of aqueous fluid from the anterior chamber of the eye into nearby subconjunctival space, all in relief of a glaucomatous condition of excessive pressure within the eye. The device includes provision for so controlling the rate of aqueous flow as to assure against anterior-chamber collapse, thus avoiding irreparable damage which might otherwise result to the corneal endothelium, to the iris, or to the lens of the eye.

Claims

1. An aqueous-drainage device for surgical implantation for the relief of aqueous fluid and intraocular pressure in a glaucomatous eye, comprising tubular means with longitudinally spaced retaining formations for retaining engagement to inner and outer limits of a local surgical bore to the anterior chamber of the eye and through a scleral part of the eye, and flow-restricting means associated with said tubular means and operative for at least a predetermined initial period of fluid exposure to substantially reduce the capacity of said tubular means to accommodate fluid flow, said flow-restricting means including a plug of liquid-absorbing material that is porous to the extent of permitting a substantially lesser flow than would be permitted by the tubular bore of said device in the absence of said plug, and a flexible filamentary element connected at one end to said plug, said filamentary element extending through said tubular means and beyond the open outer-limit end thereof.

2. An aqueous-drainage device for surgical implantation for the relief of aqueous fluid and intraocular pressure in a glaucomatous eye, comprising tubular means with longitudinally spaced retaining formations for retaining engagement to inner and outer limits of a local surgical bore to the anterior chamber of the eye and through a scleral part of the eye, and flow-restricting means associated with said tubular means and operative for at least a predetermined initial period of fluid exposure to substantially reduce the capacity of said tubular means to accommodate fluid flow, at least the outer-limit end of said tubular means being flexible, and said flow-restricting means being a clamp squeezing said flexible end and establishing a substantially reduced initial aqueous-flow capacity of said device, said clamp including a deformable element in squeezing confinement of said flexible end.

3. The device of claim 2, in which said deformable element is of shrinkable material that is shrinkable in response to an applied irradiation, whereby upon shrinkage of said material, the aqueous-flow capacity of said tubular means will increase.

4. An aqueous-drainage device for surgical implantation for the relief of aqueous fluid and intraocular pressure in a glaucomatous eye, comprising tubular means with longitudinally spaced retaining formations for retaining engagement to inner and outer limits of a local surgical bore to the anterior chamber of the eye and through a scleral part of the eye, the outer end of said tubular means being flexible, and flow-restricting means including a clamp squeezing and flexible end and establishing a substantially reduced initial aqueous-flow capacity of said device, said clamp including a deformable element in squeezing confinement of said flexible end, said deformable element being of a biologically inert material that is soluble in response to body-fluid exposure, whereby upon implantation and resultant exposure to body fluid, the aqueous flow capacity of said tubular means will increase.

5. The method of establishing controlled drainage of aqueous-humor fluid and relief of intraocular pressure in a glaucomatous eye, comprising the steps of surgically preparing a drainage hole through tissues of the cornea and adjacent sclera with the hole extending on a generally radially inward alignment between subconjunctival space and a corner of the anterior chamber;

and thereafter transiently and compliantly dilating tissues around the hole, in the course of insertionally implanting in the hole a cylindrical tube selected for spaced radially outward retaining-flange formations one of which is at the inserted end of the tube, wherein the cylindrical outer diameter is sized to fit the drilled-hole diameter and wherein the spacing between the inner and outer flange formations accords substantially with the axial extent of the drilled hole and wherein the bore of the cylindrical tube has a temporary flow restriction that is operative for at least a predeterminable initial period of fluid exposure to substantially restrict what would otherwise by the capacity of the tube to accommodate fluid flow.

6. The method of claim 5, wherein the material of the flow restriction is selected for its properties of being biologically inert and soluble in response to the body-fluid exposure.

7. The method of claim 5, wherein the flow restriction is selected for its property of dimensional response to incident radiation, and the further step of selectively exposing the flow restriction to such radiation whereby to selectively control the drainage-flow rate through the fitted tube.

8. An aqueous-drainage device for surgical implantation for the relief of aqueous-humor fluid and intraocular pressure in a glaucomatous eye, comprising tubular means with two longitudinally spaced radially outward retaining formations for retaining engagement to inner and outer limits of a local surgical bore to the anterior chamber of the eye and through a scleral part of the eye, one of said retaining formations being at the inner end of said tubular means and the other end of said tubular means extending outwardly beyond the other of said retaining formations, and flow-restricting means associated with said other end and operative for at least a predetermined initial period of fluid exposure to substantially reduce the capacity of said tubular means to accommodate fluid flow.

9. The device of claim 8, in which said flow-restricting means is a soluble plug of bio-compatible material.

10. The device of claim 8, wherein said tubular means is cylindrically annular, and said retaining means comprises axially spaced radially outward flange formations.

11. The device of claim 10, in which at least the inner-limit flange has a frusto-conical outer surface which tapers radially inwardly in the axial direction away from the outer-limit flange.

12. The device of claim 10, in which said flow-restricting means is a clamp squeezing said flexible end and establishing a substantially reduced initial aqueous-flow capacity of said device, said clamp including a deformable element in squeezing confinement of said flexible end.

13. The device of claim 12, in which said deformable element is of shrinkable material that is shrinkable in response to an applied irradiation, whereby upon shrinkage of said material, the aqueous-flow capacity of said tubular means will increase.

14. The device of claim 12, in which said deformable element is of a biologically inert material that is soluble in response to body-fluid exposure, whereby upon implantation and resultant exposure to body fluid, the aqueous-flow capacity of said tubular means will increase.

15. The device of claim 12, in which said deformable element comprises a first member that is shrinkable in response to an applied irradiation of a first wavelength, and a second member that is expandable in response to an applied irradiation of a second and different wavelength, whereby the aqueous-flow capacity of said tubular means may be selectively controlled via selective irradiation of one or the other of said wavelengths.

16. The device of claim 8, wherein the material of said tubular means is a silicone elastomer.

17. An aqueous-drainage device for surgical implantation for the relief of aqueous-humor fluid and intraocular pressure in a glaucomatous eye, comprising tubular means with two longitudinally spaced radially outward retaining formations for retaining engagement to inner and outer limits of a local surgical bore to the anterior chamber of the eye and through a scleral part of the eye, one of said retaining formations being at the inner end of said tubular means and the other end of said tubular means extending outwardly beyond the other of said retaining formations, and flow-restricting means associated with said other end, said flow-restricting means being selectively controllable to vary the capacity of said tubular means to accommodate fluid flow.