Glaucoma implant device and method for implanting same

• US 5,370,607 A
• Filed: 10/28/1992
• Issued: 12/06/1994
• Est. Priority Date: 10/28/1992
• Status: Expired due to Fees

• Current Assignee: Annuit Coeptis, Inc.
• Original Assignee: Annuit Coeptis, Inc.
• Inventors: Memmen, James E.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): JONES, MARYBETH O
• Application Number:
  US07/967,442
• Time in Patent Office: 769 Days
• Field of Search: 604/8-10, 604/294, 623/4
• 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

A pre-assembled, preferably single piece, device and related surgical procedure, to be surgically implanted in an eye for treating refractory glaucoma by draining aqueous out of the anterior chamber using a tubular shunt depended from a flexible band having a main reservoir and at least two wings extended in directions opposite one another away from said main reservoir, said wings each having a neck portion defining a depression in said band and an anchoring head each having a tip end and a lock end, with each said anchoring head gradually increasing in thickness to form a taper from each said tip end to each respective lock end to guide each said anchoring head under and past the extraocular muscles of the eye, which muscles then rest in said depressions locked against each said lock end , said device being further defined by a plurality of circumferential markings regularly placed along said tubular shunt for placement within the anterior chamber according to the size eye of each respective patient, and a ligature integrally formed on the exterior of said main reservoir above said tab to releasably pre-crimp said tubular shunt for restricting aqueous flow immediately after implantation of said device for a sufficient period to prevent hypotony, after which period said ligature can be released to allow for safe flow of aqueous.

Claims

1. A device to be surgically implanted in an eye for treating glaucoma by draining aqueous humor out of the anterior chamber of the eye, said device comprising:

a main reservoir having a base surface, a tube end, a flexible tube depended from said tube end and adapted to be shunted to the anterior chamber for draining fluid therefrom and into said main reservoir, and;

stabilization means comprised of a plurality of wings extended away from said main reservoir and adapted to cooperatively associate with the extraocular muscles of the eye, said wings each having an elongated neck portion and an anchoring head enlarged relative to said neck portion to allow for releasable locking engagement with the extraocular muscles.

2. The device recited in claim 1, wherein said stabilization means is further defined by a suture site tab formed integrally on said main reservoir at said tube end and adapted to receive a suture for securing said device to the sclera.

3. The device recited in claim 1, wherein:

said tube is further defined by size adjustment guide means comprised of a plurality of exterior circumferential markings regularly placed on said tube for assisting in modification of the size of said tube.

4. The device recited in claim 1, wherein:

said wings are further defined by a depression formed on said neck portion and said anchoring head each having a tip end and a lock end, with each said anchoring head gradually increasing in thickness to form a taper from each said tip end to each respective lock end.

5. The device recited in claim 4, wherein said stabilization means is further defined by a plurality of fenestrations formed through said base surface of said main reservoir for anchoring said band t the sclera by fibrosis.

6. The device recited in claim 4, wherein said stabilization means is further defined by a plurality of fenestrations formed through said base surface of said main reservoir for anchoring said band to the sclera by fibrosis and having a suture site tab formed integrally on said tube end of said main reservoir and adapted to receive a suture for securing said device to the sclera.

7. A device to be surgically implanted for treating refractory glaucoma by draining aqueous humor out of the anterior chamber of an eye, said device comprising:

a band formed of material biocompatible with the eye surface and ocular adnea, said band having a main reservoir with a base surface, a tube end and a tube bore formed at said tube end, said band further defined by a flexible tubular shunt depended from said main reservoir in cooperative coaxial association with said tube bore;

stabilization means integrally associated with said band for securing said device into implanatation position;

size guide means for assisting in adaption of said implant to variously sized eyes;

flow control means for controlling the flow of aqueous from the anterior chamber.

8. The device recited in claim 7, wherein said stabilization means is comprised of a plurality of wings extended away from said main reservoir, said wings each having a neck portion and an anchoring head.

9. The device recited in claim 8, wherein said stabilization means is further defined by a suture site tab formed integrally at said tube end of said main reservoir under said tube bore and adapted to receive a suture for further securing said device to the sclera.

10. The device recited in claim 7, wherein:

said stabilization mean sis comprised of a plurality of wings extended away from said main reservoir, said wings each having a neck portion and an anchoring head.

said size guide means is comprised of a plurality of exterior circumferential markings regularly placed on said tubular shunt.

11. The device recited in claim 7, wherein:

said stabilization means is comprised of a plurality of wings extended away from said main reservoir, said wings each having a neck portion defining a depression in said wing and an anchoring head each having a tip end and a lock end, with each said anchoring head gradually increasing in thickness to form a taper from each said tip end to each respective lock end, and a plurality of fenestrations formed through said base surface of said main reservoir for anchoring said band to the sclera by fibrosis;

said size guide means is comprised of a plurality of exterior circumferential markings regularly placed on said tubular shunt.

12. The device recited in claim 7, wherein:

said stabilization means is comprised of a plurality of wings extended away from said main reservoir, said wings each having a neck portion defining a depression in said wing and an anchoring head each having a tip end and a lock end, with each said anchoring head gradually increasing in thickness to form a taper from each said ti end to each respective lock end, said stabilization means further comprised of a suture site tab formed integrally at said tube end of said main reservoir under said tube bore and adapted to receive a suture for further securing said device to the sclera, said stabilization means further comprised of a plurality of fenestrations formed through said main reservoir for anchoring said band to the sclera;

said size guide means is comprised of a plurality of exterior circumferential markings regularly placed on said tubular shunt.

13. The device recited in claim 7, wherein said flow control means is comprised of a ligature formed of a gradually dissolvable material.

14. The device recited in claim 13, wherein said ligature is formed of a colored pigment to be located readily for early release by severing said ligature before natural dissolution.

15. The device recited in claim 7, wherein said flow control means is comprised of interior baffling formed within said main reservoir.

16. The device recited in claim 7, wherein said flow control means is comprised of interior baffling formed within said main reservoir to hold and distribute aqueous humor drained into said main reservoir for absorption into the subconjunctival space and surrounding tissue, said flow control means being further defined by a ligature formed of a gradually dissolvable material and a colored pigment.

17. The device recited in claim 7, wherein:

said stabilization means is comprised of a plurality of wings extended away from said main reservoir, said wings each having a neck portion defining a depression in said wing and an anchoring head each having a tip end and a lock end, with each said anchoring head gradually increasing in thickness to form a taper from each said tip end to each respective lock end, said stabilization means being further comprised of a suture site tab formed integrally at said tube end of said main reservoir and adapted to receive a suture for further securing said device to the sclera, said stabilization means being further comprised of a plurality of fenestrations formed through said base surface of said main reservoir for anchoring said band to the sclera by fibrosis;

said size guide means is comprised of a plurality of exterior circumferential markings regularly placed on said tubular shunt; and

said flow control means is comprised of interior baffling formed within said main reservoir, and a ligature formed to crimp said tubular shunt upon implantation, said ligature being comprised of a gradually dissolvable material formed of a colored pigment.

18. A pre-assembled, flexible implant device to be surgically implanted in an eye for treating refractory glaucoma by draining aqueous humor out of the anterior chamber of the eye using a shunt, said device comprising:

a band having a main reservoir with a base surface, a tube end, and a tube bore formed at said tube end, said band further defined by a tubular shunt depended from said main reservoir in cooperative coaxial association with said tube bore;

stabilization means integrally associated with said band for securing said device into implantation position;

size guide means for assisting in adaptation of said implant to variously sized eyes; and

flow control means for controlling the flow of aqueous humor from the anterior chamber.

19. The device recited in claim 18, wherein:

said band is formed of material biocompatible with the eye surface and ocular adnea;

said stabilization means is comprised of a plurality of wings extended away from said main reservoir, said wings each having a neck portion and an anchoring head.

20. The device recited in claim 18, wherein said band is formed of silicone.

21. The device recited in claim 18, wherein:

said band is formed of material biocompatible with the eye surface and ocular adnea;

said stabilization means is comprised of a plurality of wings extended away from said main reservoir, said wings each having a neck portion and an anchoring head, said stabilization means being further defined by a suture site tab formed integrally on said main reservoir at said tube end and adapted to receive a suture for further securing said device to the sclera.

22. The device recited in claim 18, wherein:

said band is formed of material biocompatible with the eye surface and ocular adnea;

said stabilization means is comprised of a plurality of wings extended away from said main reservoir, said wings each having a neck portion and an anchoring head;

said size guide means is comprised of a plurality of exterior circumferential markings regularly placed on said tubular shunt.

23. The device recited in claim 18, wherein:

said band is formed of material biocompatible with the eye surface and ocular adnea;

said stabilization means is comprised of a plurality of wings extended away from said main reservoir, said wings each having a neck portion defining a depression is said wing and an anchoring head each having a tip end and a lock end, with each said anchoring head gradually increasing in thickness to form a taper from each said tip end to each respective lock end;

said size guide means is comprised of a plurality of exterior circumferential markings regularly placed on said tubular shunt.

24. The device recited in claim 18, wherein:

said band is formed of material biocompatible with the eye surface and ocular adnea;

said stabilization means is comprised of a plurality of wings extended away from said main reservoir, said wings each having a neck portion defining a depression is said wing and an anchoring head each having a tip end and a lock end, with each said anchoring head gradually increasing in thickness to form a taper from each said tip end to each respective lock end, said stabilization means being further comprised of a plurality of fenestrations formed through said base surface of said main reservoir for anchoring said band to the sclera by fibrosis;

said size guide means is comprised of a plurality of exterior circumferential markings regularly placed on said tubular shunt.

25. The device recited in claim 18, wherein:

said band is formed of material biocompatible with the eye surface and ocular adnea;

said stabilization means is comprised of a plurality of wings extended away from said main reservoir, said wings each having a neck portion defining a depression in said wing and an anchoring head each having a tip end and a lock end, with each said anchoring head gradually increasing in thickness to form a taper from each said tip end to each respective lock end, said stabilization means being further comprised of a suture site tab formed integrally on said main reservoir at said tube end and adapted to receive a suture for securing said device to the sclera, said stabilization means being still further comprised of a plurality of fenestrations formed through said main reservoir for anchoring said band to the sclera by fibrosis;

said size guide means is comprised of a plurality of exterior circumferential markings regularly placed on said tubular shunt.

26. The device recited in claim 18, wherein said flow control means is comprised of a ligature formed of a gradually dissolvable material.

27. The device recited in claim 26, wherein said ligature is formed of a colored pigment.

28. The device recited in claim 18, wherein said flow control means is comprised of interior baffling formed within said main reservoir.

29. The device recited in claim 18, wherein said flow control means is comprised of interior baffling formed within said main reservoir and a ligature affixed to said device in position to crimp said tubular shunt near said main reservoir to prevent fluid flow at implantation, said ligature being formed of gradually dissolvable material and a colored pigment.

30. The device recited in claim 18, wherein:

said band is formed of material biocompatible with the eye surface and ocular adnea;

said stabilization means is comprised of a plurality of wings extended away from said main reservoir, said wings each having a neck portion defining a depression in said wing and an anchoring head each having a tip end and a lock end, with each said anchoring head gradually increasing in thickness to form a taper from each said tip end to each respective lock end;

said size guide means is comprised of a plurality of exterior circumferential markings regularly placed on said tubular shunt,

said flow control means is comprised of interior baffling formed within said main reservoir and a ligature affixed to said device in position to crimp said tubular shunt near said main reservoir to prevent fluid flow at implantation, said ligature being formed of a gradually dissolvable material and a colored pigment.

31. A pre-assembled, flexible implant device to be surgically implanted for treating refractory glaucoma by draining aqueous out of the anterior chamber of an eye, said device comprising:

a band having a main reservoir having a tube end, external baffling, a bottom wall, and a tube bore formed at said tube end, said band further defined by a tubular shunt depended from said main reservoir in cooperative coaxial association with said tube bore, said band further defined by at least two wings extended away from said main reservoir in opposite directions relative to one another, said wings each having a neck portion and an anchoring head, said neck portion forming a depression in said wing and each said anchoring head gradually increasing in thickness to with each said anchoring head gradually increasing in thickness to form a taper from each said tip end to each respective lock end to guide each said anchoring head under and past the extraocular muscles of the eye which then lock against each said lock end and rest in said depressions, said band being further defined by a suture site tab integrally formed on said main reservoir outside said exterior baffling and under said tube bore;

a plurality of circumferential markings regularly placed on said tubular shunt to assist in sizing said tubular shunt for placement within the anterior chamber according to the size of the eye;

a ligature integrally formed on the exterior of said main reservoir above said tab to releasably pre-crimp said tubular shunt.

32. The device recited in claim 31, wherein said wings are comprised of two in number, extended in linear alignment away from said main reservoir in opposite directions relative to one another.

33. The device recited in claim 31, wherein said circumferential markings are placed between one to three millimeters apart.

34. A method for treating glaucoma with a surgical implant device formed from a flexible band that is biocompatible with the eye surface and ocular adnea, said band having a main reservoir, a flexible tubular shunt depended from said main reservoir, and stabilization means comprised of a plurality of wings extended away from said main reservoir, said method comprising the steps of:

dissecting a conjunctival flap in the superotemporal eye quadrant;

clearing the implant field;

marking a suture site after clearing the implant field;

passing a suture through the sclera at said suture site;

forming a apracentesis to access the anterior chamber;

securing the device on the eye using said stabilization means as further comprised of a tab integrally formed on said main reservoir between said wings, said step of securing the device being comprised of placing said wings under and past the superior and lateral or medial muscles of the eye, than threading and knotting said pre-placed suture through said tab to stabilize said device in the field;

adapting said tubular shunt by trimming it at one of a plurality of circumferential markings regularly placed on said tubular shunt as eye size adjustment means for sizing said tubular shunt to the appropriate length for correct patient fit in the anterior chamber;

suturing closed the tenon'"'"'s capsule and the conjunctive.

35. The method recited in claim 34, further defined by directing antifibroblastic agents beneath the anterior and posterior lips of the conjuctival flaps after clearing the implant field but before introducing said device to the field, allowing said antifibroblastic agents to remain as placed for a short period of time, then irrigating the field with copious amounts of balanced salt solution.

36. The method recited in claim 34, further defined by injecting a viscolastic agent into the anterior chamber through the drainage tube incision site before insertion of said drainage tube into the anterior chamber.