Device and method for manual retinal vein catheterization

• US 7,217,263 B2
• Filed: 01/03/2001
• Issued: 05/15/2007
• Est. Priority Date: 01/03/2000
• Status: Expired due to Term

• Current Assignee: Johns Hopkins University
• Original Assignee: Johns Hopkins University
• Inventors: Humayun, Mark S., Jensen, Patrick S., Hamza, Hany S., Fujii, Gildo Y., Shelley, Terry H., deJuan, Eugene Jr., Barnes, Aaron C.
• Primary Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US09/754,094
• Publication Number:
  US 20020002362A1
• Time in Patent Office: 2,323 Days
• Field of Search: 604/264, 604/521, 604/272, 604/500, 604/93.01, 604/161, 604/523, 604/524, 604/525, 604/530, 606/4, 606/15, 606/44
• US Class Current: 604/523
• CPC Class Codes: A61B 2017/00345 Micromachines, nanomachines, microsystems
• CPC Class Codes: A61B 34/76 Manipulators having means for providing feel, e.g. force or tactile feedback
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/007 Methods or devices for eye surgery
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00

Abstract

A microcatheter system that allows for vascular infusion into retinal veins for extended periods of time. The microcatheter system includes a flexible cannula that is inserted into the retinal vein lumen and that remains stably within the retinal vein lumen without being held by a robot, micromanipulator or similar holding devices. The microcatheter system is particularly suitable for the treatment of retinal venous occlusive disease.

Claims

1. A microcatheter system for infusion of a solution into a retinal vein, wherein the microcatheter system remains within the retinal vein during the infusion without an external holding device for at least a period of time required for a bolus injection, comprising:

a flexible cannula mounted in a second cannula, at least a portion of the second cannula, configured to be disposed within the eve when the microcatheter system is placed within the eye for infusion into a retinal vein, at least a portion of the flexible cannula, configured to be disposed within the retinal vein when the microcatheter system is placed within the eye for infusion into a retinal vein, wherein the flexible cannula and the second cannula form an infusion fluid path and wherein the flexible cannula has an outer diameter less than about 100 μ

m.

4. The microcatheter system of any one of claims 1 through 3, wherein solution is infused at a flow rate of at least about 0.2 cc/mm.

5. The microcatheter system of any one of claims 1 through 3, wherein the microcatheter system comprises a flexible cannula for insertion into a retinal vein lumen, the flexible cannula having a proximal end and a distal end and the distal end is sharp and rigid for puncturing the retinal vein lumen.

6. The microcatheter system of claim 5, wherein the distal end has a beveled ramp-like shape.

7. The microcatheter system of claim 6, wherein the ramp-like distal end forms an angle of about 30°

.

8. The microcatheter system of any one of claims 1 through 3, wherein the flexible cannula is fabricated of polyimide.

9. The microcatheter system of any one of claims 1 through 3, wherein the flexible cannula has an outer diameter of from about 50 μ

m to about 80 μ

m.

10. The microcatheter system of claim 9, wherein the flexible cannula has an outer diameter of about 66 μ

m.

11. The microcatheter system of any one of claims 1 through 3, further comprising a second cannula having a larger diameter than the flexible cannula.

12. The microcatheter system of claim 11, wherein the second cannula is less flexible than the flexible cannula.

13. The microcatheter system of claim 11, wherein second cannula has a proximal end and a distal end, and a portion of the flexible cannula is housed within the distal end of the second cannula.

14. The microcatheter system of claim 13, wherein the second cannula forms a fluid-tight seal about the flexible cannula.

15. The microcatheter system of claim 11, wherein the proximal end of the second cannula is sized for attachment to the tip of a syringe through which solution is infused.

16. The microcatheter system of claim 11, wherein the second cannula has an outer diameter that ranges from about 400 μ

m to about 800 μ

m.

17. The microcatheter system of claim 16, wherein the second cannula has an outer diameter of about 556 μ

m.

18. The microcatheter system of claim 11, further comprising a modified microcannula system in which the flexible cannula and second cannula are mounted.

19. The microcatheter system of any one of claims 1 through 3, wherein the microcannula system further includes an inner plug mounted on the modified microcannula system and the inner plug is fabricated of silicone.

20. The microcatheter system of any one of claims 1 through 3, wherein the microcannula system further includes an inner plug mounted on the modified microcannula system and the inner plug has an aperture through which the second cannula and flexible cannula are inserted.

21. The microcatheter system of any one of claims 1 through 3, wherein the microcannula system further includes an inner plug mounted on the modified microcannula system and the inner plug forms a fluid-tight seal about the second cannula.

22. The microcatheter system of any one of claims 1 through 3, wherein the flexible cannula is illuminated for enhanced visibility.

23. The microcatheter system of any one of claims 1 through 3 wherein the microcatheter system or flexible cannula remains within the retinal vein during the infusion without an external holding device for a period of time of at least 5 minutes.

24. The microcatheter system of claim 23, wherein the period of time is at least 10 minutes.

25. The microcatheter system of claim 24, wherein the period of time is at least 20 minutes.

26. The microcatheter system of claim 25, wherein the period of time is at least 30 minutes.

27. The microcatheter system of claim 26, wherein the period of time is at least 40 minutes.

28. The microcatheter system of claim 27, wherein the period of time is at least 50 minutes.

29. The microcatheter system of claim 28, wherein the period of time is at least one hour.

30. The microcatheter system of claim 29, wherein the period of time is at least one and a half hours.

31. The microcatheter system of claim 30, wherein the period of time is at least two hours.

32. A medical device kit, comprising one or more of the microcatheter systems of any one of claims 1 through 3.

33. The kit of claim 32 wherein the one or more microcatheter systems are packaged in sterile condition.

34. The microcatheter system of any one of claims 1 through 3, wherein the flexible cannula comprises a flexible body and a rigid tip for puncturing the retinal vein lumen.

35. The microcatheter system of claim 34, wherein at least a portion of the rigid tip is disposed within the retinal vein when the second cannula is disposed within the eye.

2. A microcatheter system comprising:

a flexible cannula configured for insertion into a retinal vein lumen, the flexible cannula having an outer diameter less than about 100 μ

m, whereby a solution is infused into the retinal vein lumen through the flexible cannula and the flexible cannula remains within the retinal vein lumen during the infusion without an external holding device for at least a period of time required for a bolus injection; and

a second cannula configured to be disposed within the eye when the flexible cannula is inserted into a retinal vein, wherein the microcatheter system comprises the flexible cannula at least partially encased in the second cannula, wherein the flexible cannula and the second cannula form an infusion fluid path.

3. A microcatheter system comprising:

a flexible cannula for insertion into a retinal vein lumen, the flexible configured cannula having an outer diameter less than about 100 μ

m, whereby a solution is infused into the retinal vein lumen through the flexible cannula and the flexible cannula remains within the retinal vein lumen during the infusion without an external holding device; and

a second cannula configured to be disposed within the eve when the flexible cannula is inserted into a retinal vein, wherein the microcatheter system comprises the flexible cannula mounted in the second cannula, wherein the flexible cannula and the second cannula form an infusion fluid path.

36. A method for manual retinal vein catheterization comprising inserting a microcatheter system within a retinal vein and infusing solution into the retinal vein, whereby the microcatheter system remains within the retinal vein without an external holding device, wherein the microcatheter system comprises a flexible cannula mounted in a second cannula, wherein the flexible cannula and the second cannula form an infusion fluid path.

37. The method of claim 36, wherein solution is infused at a flow rate of at least about 0.2 cc/mm.

38. The method of claim 36, further comprising inserting a metal cannula into an incision in the eye prior to inserting the microcatheter system into the eye, whereby the microcatheter system is inserted into the eye through the metal cannula.

39. The method of claim 38, further comprising insertion of a microcannula through the metal cannula, wherein the microcatheter system is inserted into the eye through the metal cannula.

40. The method of claim 36, further comprising the step of making four sclerotomies in the eye, whereby two microforceps are inserted in two of the sclerotomies and the microcatheter system is inserted into the eye through the fourth sclerotomy.

41. The method of claim 40, wherein the fourth sclerotomy site is made such that the microcatheter system is inserted into the eye with the flexible cannula approximately parallel to the retinal vein.

42. The method of claims 40 or 41, further comprising the step of using the microforceps to direct the flexible cannula towards the optic disc of the eye.

43. The method of claim 40, further comprising the steps of passing the microcatheter system back and forth between the microforceps to position the microcatheter system so that the distal end of the flexible cannula is approximately parallel to the retinal vein.

44. The method of claim 36, wherein the microcatheter system further comprises a second cannula having a larger diameter than the flexible cannula, the second cannula having a proximal end and a distal end, whereby a portion of the flexible cannula is housed within the distal end of the second cannula.

45. The method of claim 44, wherein the proximal end of the second cannula is attached to the tip of a syringe through which solution is infused, and the second cannula forms a fluid-tight seal about the flexible cannula.

46. The method of claim 36, wherein the microcatheter system or flexible cannula remains within the retinal vein during the infusion without an external holding device for a period of time of at least 5 minutes.

47. The method of claim 46, wherein the period of time is at least 10 minutes.

48. The method of claim 47, wherein the period of time is at least 20 minutes.

49. The method of claim 48, wherein the period of time is at least 30 minutes.

50. The method of claim 49, wherein the period of time is at least 40 minutes.

51. The method of claim 50, wherein the period of time is at least 50 minutes.

52. The method of claim 51, wherein the period of time is at least one hour.

53. The method of claim 52, wherein the period of time is at least one and a half hours.

54. The method of claim 53, wherein the period of time is at least two hours.