Composite ophthalmic microcannula

• US 20050171507A1
• Filed: 01/24/2005
• Published: 08/04/2005
• Est. Priority Date: 01/23/2004
• Status: Active Grant

• Current Assignee: Nova Eye Incorporated
• Original Assignee: IScience Surgical Corp. (iScience Interventional Corporation)
• Inventors: Conston, Stanley R., Kupiecki, David J., Christian, Jeffrey J., McKenzie, John
• Granted Patent: US 7,207,980 B2
• Time in Patent Office: Days
• US Class Current: 604/524
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 3/0008 provided with illuminating means A61B3/117 takes precedence; goniolenses used for laser treatment A61F9/009; illuminating means for optical instruments G02B27/00
• CPC Class Codes: A61F 9/007 Methods or devices for eye surgery
• 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 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids

Abstract

Microcannulae are constructed with multiple components in a composite design, allowing the microcannulae to have varying mechanical and delivery properties that will enable ophthalmic treatments by minimally invasive means. The microcannula includes at least one flexible, tubular communicating element with an outer diameter of 350 microns or less, a proximal connector for introduction of materials, energy or tools. It may also include a reinforcing member attached to the communicating element, which may be designed to create variable stiffness along the length of the microcannula. The microcannula may also include other features such as a signal beacon near the distal tip.

Claims

1. A composite microcannula for access and advancement into a tissue space of the eye comprising:

at least one flexible, tubular communicating element configured to fit within the tissue space and having an outer diameter of no more than 350 microns, the communicating element having a proximal end and a distal end;

a proximal connector attached to said proximal end, said proximal connector configured for introduction of materials, energy or tools;

and a reinforcing member connected with the communicating element.

2. The microcannula of claim 1, wherein the composite microcannula has a flexural rigidity in the range of 3.09 E-11 to 2.86 E-10 kN*m².

3. The microcannula of claim 1, wherein the reinforcing member provides greater axial and flexural stiffness at the proximal end of the microcannula as compared to the distal end of the microcannula.

4. The microcannula of claim 1, wherein the reinforcing element is malleable to allow manual shaping of the microcannula.

5. The microcannula of claim 1, wherein the reinforcing element comprises a metal.

6. The microcannula of claim 1, wherein the communicating element comprises a flexible polymer and the reinforcing member comprises a metal.

7. The microcannula of claim 1, wherein the microcannula comprises a signal beacon capable of identifying a position of the distal tip.

8. The microcannula of claim 1, wherein the microcannula further comprises at least one additional communicating element.

9. The microcannula of claim 8, wherein one of the communicating elements provides a signal beacon at the microcannula distal tip.

10. The microcannula of claim 8, wherein the additional communicating element is located within the lumen of the first communicating element.

11. The microcannula of claim 10, wherein the communicating elements are in concentric alignment.

12. The microcannula of claim 8, wherein the communicating elements are in parallel alignment

13. The microcannula of claim 1, wherein the microcannula comprises two or more reinforcing elements.

14. The microcannula of claim 1, wherein the reinforcing element comprises a coil.

15. The microcannula of claim 1, wherein the reinforcing element is tapered toward the distal end of the microcannula.

16. The microcannula of claim 1, wherein the communicating element includes a segment chosen from the group consisting of a segment of tubing, a segment of optical fiber and a segment of an electrical conductor.

17. The microcannula of claim 1, wherein the microcannula is configured to fit within a tissue space selected from the group consisting of Schlemm'"'"'s Canal, an aqueous collector channel, an aqueous vein, a suprachoroidal space and a retinal blood vessel of the eye.

18. The microcannula of claim 1, wherein the distal end has a rounded distal tip.

19. The microcannula of claim 18, wherein the communicating element comprises an optical fiber capable of delivering light to the rounded tip and wherein, when light is delivered to said rounded tip, said rounded tip acts to disperse the light for improved off-axis visualization.

20. The microcannula of claim 1, wherein the communicating element and the reinforcing element are joined by an outer sheath.

21. The microcannula of claim 20, wherein the outer sheath comprises heat shrink tubing.

22. The microcannula of claim 1, wherein the communicating element and the reinforcing element are joined with an adhesive.

23. The microcannula of claim 1, additionally comprising a lubricious outer coating.

24. A composite microcannula for access and advancement into a tissue space of the eye comprising:

at least one flexible, tubular communicating element with an outer diameter of no more than 350 microns, said communicating element having a proximal end, a distal end, and a fluid communicating lumen,

a proximal connector configured for delivery of fluid,

a signal beacon,

and a second communicating element configured to deliver the signal beacon, the signal beacon being capable of identifying the microcannula distal tip.

25. The composite microcannula of claim 24, wherein the second communicating element comprises an optical fiber and the signal beacon delivers visible light.

26. The microcannula of claim 24, wherein the composite microcannula has a flexural rigidity in the range of 3.09 E-11 to 2.86 E-10 kN*m².

27. The composite microcannula of claim 24, additionally comprising a rounded distal tip.

28. The composite microcannula of claim 27, wherein the rounded distal tip acts to disperse the signal beacon for improved off-axis visualization.

29. A system for performing ophthalmic surgery, the system comprising:

a composite microcannula for access and advancement into a tissue space of an eye, the microcannula including;

at least one flexible, tubular communicating element configured to fit within the tissue space and having an outer diameter of no more than 350 microns, the communicating element having a proximal end and a distal end;

a proximal connector attached to said proximal end, said proximal connector configured for introduction of materials, energy or tools;

and a distal opening;

and a lubricating fluid,

wherein said distal opening is located to allow delivery of said lubricating fluid into the tissue space around said distal end.

30. The system of claim 29, further comprising a second communicating element.

31. The system of claim 30, wherein the second communicating element has a signal beacon capable of identifying a position of a distal tip of the microcannula.

32. The microcannula of claim 30, wherein where the second communicating element is located within the lumen of the first communicating element.

33. The microcannula of claim 30, wherein the communicating elements are in concentric alignment.

34. The microcannula of claim 30, wherein the communicating elements are in parallel alignment

35. The microcannula of claim 29, wherein the composite microcannula has a flexural rigidity in the range of 3.09 E-11 to 2.86 E-10 kN*m².

36. The microcannula of claim 29, wherein the composite microcannula provides greater axial and flexural stiffness at the proximal end of the microcannula as compared to the distal end of the microcannula.

37. The system of claim 29, wherein the microcannula includes a reinforcing member connected with the communicating element.

38. The microcannula of claim 37, where the reinforcing element is malleable to allow manual shaping of the microcannula.

39. The microcannula of claim 37, wherein the reinforcing element comprises a metal.

40. The microcannula of claim 37, wherein the reinforcing element comprises a coil.

41. The microcannula of claim 37, wherein the reinforcing element is tapered toward the distal end of the microcannula.

42. The microcannula of claim 37, wherein the communicating element and the reinforcing element are joined by an outer sheath.

43. The microcannula of claim 42, wherein the outer sheath comprises heat shrink tubing.

44. The microcannula of claim 37, wherein the communicating element and the reinforcing element are joined with an adhesive.

45. The microcannula of claim 29, wherein the communicating element comprises a flexible polymer.

46. The microcannula of claim 29, wherein the microcannula comprises two or more reinforcing elements.

47. The microcannula of claim 29, wherein the communicating element includes a segment chosen from the group consisting of a segment of tubing, a segment of optical fiber and a segment of an electrical conductor.

48. The microcannula of claim 29, wherein the microcannula is configured to fit within a tissue space is selected from the group consisting of Schlemm'"'"'s Canal, an aqueous collector channel, an aqueous vein, a suprachoroidal space and a retinal blood vessel of the eye.

49. The microcannula of claim 29, wherein the distal end has a rounded distal tip.

50. The microcannula of claim 49, wherein the communicating element comprises an optical fiber capable of delivering light to the rounded tip and wherein, when light is delivered to said rounded tip, said rounded tip acts to disperse the light for improved off-axis visualization.

51. The microcannula of claim 29 additionally comprising a lubricious outer coating.

52. The microcannula of claim 29, wherein the lubricating fluid is a viscoelastic fluid.

53. A method of performing ophthalmic surgery, the method comprising the steps of:

(a) forming an incision in an eye to access a tissue space within the eye;

(b) placing a tip of a microcannula into the tissue space;

(c) advancing to the microcannula along the tissue space;

(d) while delivering a lubricating fluid into the tissue space distal to the tip of the microcannula;

54. The method of claim 53, wherein the fluid delivered in step (d) is a viscoelastic fluid.

55. The method of claim 53, further comprising the steps of:

(e) activating a signal beacon capable of identifying a location of a distal tip of the microcannula;

(f) identifying the location of the distal tip of the microcannula by locating the source of the signal beacon.