INSTRUMENTS AND METHODS FOR IMPLANTING CORNEAL IMPLANT VIA EXTRA-AND INTRA-CAMERAL ROUTES

• US 20090043242A1
• Filed: 08/07/2007
• Published: 02/12/2009
• Est. Priority Date: 08/07/2007
• Status: Abandoned Application

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: McGraw, Michael J., Taylor, Margaret, Lee, Ed, Bene, Eric A., Bowen, Mark
• Application Number:
  US11/835,070
• Publication Number:
  US 20090043242A1
• 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

A method of implanting a transcorneal shunt into a cornea, the shunt having a head and a foot, each having a hole therein, the method including the operations of engaging an insertion tool with a foot hole of the shunt; making an entry incision in the cornea; inserting the shunt, while still engaged with the insertion tool, through the entry incision; making an implant incision in the cornea; inserting the head of the shunt through the implant incision to position and seat the shunt; and releasing the shunt from the insertion tool.

Claims

1. An apparatus, comprising:

a transcorneal shunt with a head and a foot, each having a hole therein; and

an insertion tool to insert the transcorneal shunt into a corneal incision, the insertion tool comprising a stabilizer, and an engager protruding from the stabilizer and releasably engaging the shunt,

wherein when the stabilizer contacts one of the head and foot and surrounds the corresponding hole, the engager is inserted, at least partially, into the corresponding hole, and at least a portion of an inserted length of the engager comprises an irregularity to enhance shunt engagement.

2. The apparatus according to claim 1, wherein the stabilizer comprises hollow tubing.

3. The apparatus according to claim 2, wherein the stabilizer comprises hypodermic tubing.

4. The apparatus according to claim 2, further comprising a luer connection to accommodate a syringe to inject fluid into the tubing.

5. The apparatus according to claim 1, wherein a first end of the stabilizer, at which the engager protrudes, has an angle formed therein.

6. The apparatus according to claim 5, wherein:

the stabilizer contacts the foot;

the shunt is inserted into the corneal incision intra-camerally via an entry incision; and

the angle is acute to accommodate a positioning of the corneal incision close to the entry incision.

7. The apparatus according to claim 1, wherein:

the stabilizer contacts the foot;

the shunt is inserted into the corneal incision intra-camerally via an entry incision; and

the angle is obtuse to accommodate the corneal incision being trans-corneally positioned with respect to the entry incision.

8. The apparatus according to claim 1, wherein a first end of the stabilizer, at which the engager protrudes, has a curve formed therein.

9. The apparatus according to claim 1, wherein a distal end of the stabilizer, at which the engager protrudes, is recessed to accommodate a shape of the head.

10. The apparatus according to claim 9, wherein the distal end of the stabilizer is machined to a radius to conform to the shape of the head.

11. The apparatus according to claim 1, wherein a distal end of the stabilizer, at which the engager protrudes, is approximately perpendicular to a side of the stabilizer immediately adjacent to the distal end of the stabilizer.

12. The apparatus according to claim 1, wherein the stabilizer and the engager are integrally formed as a unitary construction.

13. The apparatus according to claim 1, wherein the at least portion of the inserted length of the engager comprises a plurality of irregularities to enhance shunt engagement.

14. The apparatus according to claim 1, wherein the irregularity comprises a raised feature to engage the shunt.

15. The apparatus according to claim 1, wherein the irregularity comprises a tapered undercut.

16. The apparatus according to claim 1, wherein the irregularity comprises a groove.

17. The apparatus according to claim 16, wherein the groove comprises one of a v-groove, a rounded groove, and a square groove.

18. The apparatus according to claim 1, wherein the irregularity comprises a helical thread.

19. The apparatus according to claim 1, wherein the irregularity comprises a ball-shape.

20. The apparatus according to claim 1, wherein the shunt comprises one of silicone rubber and polyurethane.

21. The apparatus according to claim 1, wherein the shunt comprises at least one of glass, ceramic, polycarbonate, acrylic resin, stainless steel, titanium, silver, gold, and platinum.

22. The apparatus according to claim 1, wherein the stabilizer comprises one of stainless steel, rigid plastic resin, polycarbonate, and titanium.

23. The apparatus according to claim 1, wherein the engager comprises one of stainless steel, rigid plastic resin, polycarbonate, and titanium.

24. The apparatus according to claim 1, wherein the insertion tool further comprises a handle connected to the stabilizer to aid manipulation of the insertion tool.

25. The apparatus according to claim 1, further comprising:

an incision-making device,

wherein the engager is inserted into the foot hole, and a portion of the incision-making device is inserted into the head hole, so that during an intra-cameral insertion of the transcorneal shunt, the incision making device is used to make the corneal incision into which the shunt is inserted.

26. An apparatus, comprising:

a hydrogel transcorneal shunt with a head and a foot, each having a hole therein; and

an insertion tool to insert the transcorneal shunt into a corneal incision, the insertion tool comprising a stabilizer, and an engager protruding from the stabilizer and releasably engaging the shunt,

wherein when the stabilizer contacts one of the head and foot and surrounds the corresponding hole, the engager is inserted, at least partially, into the corresponding hole, and the engager has at least a portion of an inserted portion thereof that is sized to be greater than a size, when the shunt is dehydrated, of the one of the head and foot holes the engager is inserted into, and less than the size, when the shunt is hydrated, of the one of the head and foot holes the engager is inserted into.

27. The apparatus according to claim 26, wherein a diameter of the portion of the inserted portion of the engager is greater than the diameter, when the shunt is dehydrated, of the of the one of the head and foot holes the engager is inserted into, and less than the diameter, when the shunt is hydrated, of the one of the head and foot holes the engager is inserted into.

28. An apparatus, comprising:

a transcorneal shunt with a head and a foot, each having a hole therein; and

an insertion tool to insert the transcorneal shunt into a corneal incision, the insertion tool comprising a stabilizer, and an engager protruding from the stabilizer and releasably engaging the shunt, the engager comprising a hollow tube, and a plunger movably disposed within the hollow tube,

wherein when the stabilizer contacts one of the head and foot and surrounds the corresponding hole, the engager is inserted, at least partially, into the corresponding hole.

29. The apparatus according to claim 28, wherein:

the plunger has a distal end larger than an internal diameter of the hollow tube; and

the distal end of the plunger is retracted into the hollow tube to elastically expand a distal end of the hollow tube to engage the shunt.

30. The apparatus according to claim 28, wherein:

the hollow tube has a slotted tip;

a distal end of the hollow tube has a thickness greater than a thickness of a remainder of the hollow tube; and

the plunger is pushed down into the distal end of the hollow tube to elastically expand the distal end of the hollow tube to engage the shunt.

31. An apparatus, comprising:

a hydrogel transcorneal shunt with a head and a foot, each having a hole therein; and

an insertion tool to insert the transcorneal shunt into a corneal incision, the insertion tool comprising a handle to aid in manipulating the insertion tool, a stabilizer, comprising hypodermic tubing extending from the handle, and an engager protruding from the stabilizer and releasably engaging the shunt, the engager having a diameter greater than a diameter, when the shunt is dehydrated, of the of the one of the head and foot holes the engager is inserted into, and less than the diameter, when the shunt is hydrated, of the one of the head and foot holes the engager is inserted into.

32. An apparatus, comprising:

a hydrogel transcorneal shunt with a head and a foot, each having a hole therein; and

an insertion tool to insert the transcorneal shunt into a corneal incision, the insertion tool comprising a stabilizer, and an engager protruding from the stabilizer and releasably engaging the shunt, the engager automatically releasing the shunt subsequent the shunt'"'"'s insertion into the corneal incision.

33. A method of implanting a hydrogel transcorneal shunt into a cornea, comprising:

hydrating the shunt, the shunt having a head and a foot, each having a hole therein;

inserting an engager of an insertion tool into one of the head and foot holes of the hydrated shunt;

dehydrating the shunt subsequent to insertion of the engager;

inserting the dehydrated shunt into a corneal incision; and

re-hydrating the shunt to release the shunt from the insertion tool.

34. The method according to claim 33, wherein re-hydrating the shunt to release the shunt from the insertion tool comprises hydrating the shunt with aqueous humor from the cornea'"'"'s anterior chamber to automatically release the shunt from the insertion tool.

35. The method according to claim 33, wherein re-hydrating the shunt to release the shunt from the insertion tool comprises admitting fluid to the shunt via the stabilizer.

36. The method according to claim 33, wherein the engager is inserted into the head hole and the shunt is inserted into the corneal incision from outside the eye.

37. The method according to claim 33, wherein the engager is inserted into the foot hole and the shunt is inserted into the corneal incision intra-camerally.

38. A method of implanting a transcorneal shunt into a cornea, comprising:

inserting an engager of an insertion tool into one of a head and a foot hole of the shunt, and contacting a stabilizer of the insertion tool, from which the engager protrudes, to the one of the head and foot corresponding to the one of the head and foot holes the engager is inserted into, the engager comprising a hollow tube and a plunger that is movably disposed within the hollow tube;

inserting a portion of the shunt through a corneal incision to position and seat the shunt; and

releasing the shunt from the engager,

wherein releasing the shunt from the engager comprises one of extending the distal end of the plunger to a position outside of the hollow tube and retracting the plunger from the distal end of the hollow tube.

39. The method according to claim 38, further comprising:

engaging the shunt with the engager,

wherein the plunger has a distal end larger than an internal diameter of the hollow tube, engaging the shunt with the engager comprises retracting the distal end of the shunt into the hollow tube to elastically expand a distal end of the hollow tube to engage the shunt, and releasing the shunt from the engager comprises extending the distal end of the plunger to a position outside of the hollow tube.

40. The method according to claim 38, further comprising:

engaging the shunt with the engager,

wherein the hollow tube has a slotted tip, a distal end of the hollow tube is thicker than a remainder of the hollow tube, engaging the shunt with the engager comprises pushing the plunger into the distal end of the hollow tube to elastically expand a distal end of the hollow tube to engage the shunt, and releasing the shunt from the engager comprises retracting the plunger from the distal end of the hollow tube.

41. The method according to claim 38, wherein the engager is inserted into the head hole and the shunt is inserted into the corneal incision from outside the eye.

42. The method according to claim 38, wherein the engager is inserted into the foot hole and the shunt is inserted into the corneal incision intra-camerally.

43. A method of implanting a transcorneal shunt into a cornea, the shunt having a head and a foot, each having a hole therein, the method comprising:

engaging an insertion tool with a foot hole of the shunt;

making an entry incision in the cornea;

inserting the shunt, while still engaged with the insertion tool, through the entry incision;

making an implant incision in the cornea;

inserting the head of the shunt through the implant incision to position and seat the shunt; and

releasing the shunt from the insertion tool.

44. The method according to claim 43, wherein the engaging the insertion tool with the foot hole of the shunt comprises inserting an engager of the insertion tool into the foot hole of the shunt, and contacting a stabilizer of the insertion tool, from which the engager protrudes, to the foot.

45. The method according to claim 43, wherein:

the shunt comprises a hydrogel shunt; and

the engaging the insertion tool with the foot hole of the shunt comprises hydrating the shunt, inserting an engager of an insertion tool into a foot hole of the shunt, the engager protruding from a stabilizer of the insertion tool, and dehydrating the shunt.

46. The method according to claim 45, wherein the releasing the shunt from the insertion tool comprises re-hydrating the shunt.

47. The method according to claim 46, wherein re-hydrating the shunt comprises hydrating the shunt with aqueous humor from the cornea'"'"'s anterior chamber to automatically release the shunt from the insertion tool.

48. The method according to claim 46, wherein re-hydrating the shunt comprises admitting fluid to the shunt via the stabilizer.

49. The method according to claim 43, wherein the making an entry incision in the cornea comprises making an incision approximately parallel to a corresponding iris near where the cornea meets a corresponding limbus.

50. The method according to claim 43, wherein the making an implant incision in the cornea comprises making an incision approximately perpendicular to the cornea.

51. An apparatus, comprising:

a hydrogel transcorneal shunt with a head and a foot, each having a hole therein; and

an insertion tool to insert the transcorneal shunt into a corneal incision, the insertion tool comprising a shaft portion, a stabilizing portion extending from the shaft portion, and an engaging portion extending from the stabilizing portion and releasably engaging the shunt,

wherein the engaging portion has at least a portion of an inserted portion thereof that is sized to be greater than a size of the foot hole when the shunt is dehydrated, and less than the size of the foot hole when the shunt is hydrated.

52. The apparatus according to claim 51, wherein the stabilizing portion comprises an acute bend in the insertion tool.

53. The apparatus according to claim 52, wherein prior to formation of the bend, the shaft portion, the stabilizing portion, and the engaging portion have substantially the same diameter.

54. The apparatus according to claim 51, wherein the at least portion of the inserted portion of the engaging portion comprises an irregularity to enhance shunt engagement.

55. The apparatus according to claim 51, wherein the shaft portion, the stabilizing portion, and the engaging portion comprise hollow tubing.

56. The apparatus according to claim 55, further comprising a luer connection to accommodate a syringe to inject fluid into the tubing.