Method and catheter for dilatation of the lacrimal system

• US 5,021,043 A
• Filed: 09/11/1989
• Issued: 06/04/1991
• Est. Priority Date: 09/11/1989
• Status: Expired due to Term

• Current Assignee: Atrion (Atrion Corporation)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Becker, Bruce B., Berthiaume, William A.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US07/405,766
• Time in Patent Office: 631 Days
• Field of Search: 604/27-28, 604/49, 604/54, 604/96-103, 604/164, 604/264, 604/294, 128/658, 128/898, 606/192-194
• US Class Current: 606/192
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/94 Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 9/00772 Apparatus for restoration of tear ducts
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A dilatation catheter having an inflatable member and a method of using same to restore patency to an obstructed portion of the lacrimal system. The catheter is inserted into the lacrimal system and its inflatable member is positioned in the obstructed portion. The inflatable member is inflated to dilate the obstructed portion to restore patency to the lacrimal system. Preferably, the catheter includes one or more visually perceivable markers having a known spaced relationship to one of the ends of the inflatable member. Positioning of the inflatable member is assisted by aligning the marker relative to an opening into the lacrimal system.

Claims

1. A method of restoring patency to an obstructed portion of the lacrimal system of a patient, comprising:

providing a catheter having an inflatable member;

inserting the catheter into the lacrimal system;

positioning the inflatable member in the obstructed portion of the lacrimal system; and

inflating the inflatable member to dilate the obstructed portion to restore patencY to the lacrimal system.

2. The method of claim 1 wherein the provided catheter includes a visually perceivable marker having a known spaced relationship to one of the ends of the inflatable member, and positioning the inflated member includes aligning the marker relative to an opening into the lacrimal system.

3. The method of claim 2 wherein the marker is aligned relative to a punctum of the patient.

4. The method of claim 2 wherein the marker is aligned relative to the opening of the nasolacrimal duct into the nose.

5. The method of claim 2 wherein the marker is aligned relative to an ostium formed between the nose and the lacrimal sac.

6. The method of claim 1 wherein the provided catheter includes a lumen for receiving a guidewire, and inserting the catheter includes:

passing a guidewire through a first opening into the lacrimal system, through the obstruction, and out a second opening of the lacrimal system; and

advancing the catheter over the guidewire.

7. The method of claim 6 wherein advancing the catheter further includes positioning the distal end of the catheter proximate to the first opening, interlocking the proximal end of the catheter relative to the guidewire, and pulling the guidewire to draw the inflatable member into the lacrimal system.

8. The method of claim 6 further including initially passing a probe through the lacrimal system to determine a path between the first and second openings through the obstruction.

9. The method of claim 8 further including withdrawing the probe, installing a sleeve along the path, advancing the guidewire through the sleeve, and withdrawing the sleeve.

10. The method of claim 9 wherein installing the sleeve includes advancing the sleeve with a relatively rigid core along the path, and withdrawing the core while leaving the sleeve in position.

11. The method of claim 1 wherein inflating includes applying fluid under pressure to the balloon for a first period of time, deflating the balloon, and applying fluid under pressure for a second period of time.

12. The method of claim 11 wherein the first and second period of time are between 5-15 minutes each.

13. A method of restoring patency to an obstructed portion of the lacrimal system of a patient, comprising:

providing a catheter including;

a catheter body having a proximal end and a distal end;

an inflatable member formed of noncompliant material and disposed proximate to the distal end of the catheter body, the inflatable member having when inflated a center region, a distal tapered region and a proximal tapered region, the distal region attached to the distal end of the center region and the proximal tapered region attached to the proximal end of the center region; and

at least one visually perceivable marker having a known spaced relationship from one of the distal end and the proximal end of the center region for enabling alignment of the inflatable member with the obstructed portion of the lacrimal system to be dilated;

inserting the catheter into the lacrimal system;

positioning the inflatable member in the obstructed portion of the lacrimal system by aligning the marker relative to an opening into the lacrimal system; and

inflating the inflatable member to dilate the obstructed portion to restore patency to the lacrimal system.

14. The method of claim 13 wherein the provided catheter includes a lumen for receiving a guidewire, and inserting the catheter includes:

passing a guidewire through a first opening into the lacrimal system, through the obstruction, and out a second opening of the lacrimal system; and

advancing the catheter over the guidewire.

15. The method of claim 14 wherein advancing the catheter further includes positioning the distal end of the catheter proximate to the first opening, interlocking the proximal end of the catheter relative to the guidewire, and pulling the guidewire to draw the inflatable member into the lacrimal system.

16. The method of claim 15 further including initially passing a probe through the lacrimal system to determine a path between the first and second openings through the obstruction.

17. The method of claim 16 further including:

withdrawing the probe;

installing a sleeve along the path by advancing the sleeve with a relatively rigid core along the path, and withdrawing the core while leaving the sleeve in position;

advancing the guidewire through the sleeve; and

withdrawing the sleeve.

18. The method of claim 13 wherein the catheter is inserted through a punctum and associated canaliculus, and then through an ostium formed between the nose and the lacrimal sac.

19. The method of claim 18 wherein a first visually perceivable marker is spaced 9-13 mm proximal to the proximal end of the center region, and positioning the inflatable member includes aligning the first marker relative to the punctum.

20. The method of claim 19 wherein the inflatable member is translucent, a second visually perceivable marker is located beneath the inflatable member at a distance of 4-6 mm distal to the proximal end of the center region, and positioning further includes aligning the second marker relative to the ostium.

21. The method of claim 13 wherein the catheter is inserted through an ostium formed between the nose and the lacrimal sac, and then through a canaliculus and its associated punctum, and a first visually perceivable marker is spaced 9-13 mm distal to the distal end of the center region, and positioning the inflatable member includes aligning the first marker relative to the punctum.

22. The method of claim 21 wherein the inflatable member is translucent, a second visually perceivable marker is located beneath the inflatable member at a distance of 4-6 mm proximal to the distal end of the center region, and positioning further includes aligning a second marker relative to the ostium.

23. The method of claim 13 wherein the catheter is inserted through a punctum and associated canaliculus, and then through the nasolacrimal duct.

24. The method of claim 23 wherein the inflatable member is translucent, a first visually perceivable marker is located beneath the inflatable member at a distance of 4-6 mm proximal to the distal end of the center region, and positioning further includes aligning the first marker relative to the opening of the nasolacrimal duct into the nose.

25. The method of claim 24 wherein a second visually perceivable marker is spaced 9-16 mm proximal to the proximal end of the center region, and positioning the inflatable member includes aligning the second marker relative to the punctum.

26. The method of claim 25 wherein the second marker is located 9-11 mm from the proximal end of the center region, and the catheter further includes a third marker located 14-16 mm proximal to the proximal end of the center region, and positioning the inflatable member includes aligning the second and third markers relative to the punctum.

27. The method of claim 26 in which a first dilatation is performed after the first marker is aligned relative to the opening of the nasolacrimal duct, and a second dilatation is performed after aligning the second and third markers relative to the punctum.

28. The method of claim 13 wherein the catheter is inserted through a punctum and associated canaliculus for dilatation of the canaliculus.

29. The method of claim 28 wherein a first visually perceivable marker is spaced 9-16 mm proximal to the distal end of the center region, and positioning the inflatable member includes aligning the first marker relative to the punctum.

30. The method of claim 13 wherein the catheter body of the provided catheter has a distal segment and a proximal segment, the distal segment being more flexible than the proximal segment.

31. The method of claim 30 wherein the distal segment includes a slender, flexible wire.

32. The method of claim 13 wherein the provided catheter includes a lubricious coating to facilitate inserting the catheter into the lacrimal system.

33. The method of claim 32 further including topically applying the coating to the catheter body and the inflatable member.

34. A catheter for dilating an obstructed portion of the lacrimal system of a patient, comprising:

a catheter body having a proximal end and a distal end;

an inflatable member disposed proximate to the distal end of said catheter body, said inflatable member having when inflated a center region, a distal tapered region and a proximal tapered region, said distal region attached to a distal end of said center region and said proximal tapered region attached to a proximal end of said center region; and

at least one visually perceivable marker having a known spaced relationship from one of said distal end and said proximal end of said center region for enabling alignment of said inflatable member with the obstructed portion of the lacrimal system to be dilated.

35. The catheter of claim 34 wherein a first visually perceivable marker is spaced 9-13 mm proximal to said proximal end of said center region for alignment relative to a punctum of the patient.

36. The catheter of claim 35 wherein said inflatable member is translucent and a second visually perceivable marker is located beneath said inflatable member at a distance of 4-6 mm distal to said proximal end of said center region for alignment relative to an ostium formed between the nose and the lacrimal sac of the patient.

37. The catheter of claim 36 in which said inflatable member has a diameter of 3-6 mm when inflated.

38. The catheter of claim 37 in which said inflatable member has a length of 5-10 mm.

39. The catheter of claim 34 wherein a first, visually perceivable marker is spaced 9-13 mm distal to said distal end of said center region for alignment with a punctum of the patient.

40. The catheter of claim 39 wherein said inflatable member is translucent and a second visually perceivable marker is located beneath said inflatable member at a distance of 4-6 mm proximal to said distal end of said center region for alignment relative to an ostium formed between the nose and the lacrimal sac of the patient.

41. The catheter of claim 34 wherein said inflatable member is translucent and a first visually perceivable marker is located beneath said inflatable member a distance of 4-6 mm proximal to said distal end of said center region for alignment relative to the opening of the nasolacrimal duct into the nose.

42. The catheter of claim 41 wherein a second visually perceivable marker is spaced 9-16 mm proximal to said proximal end of said center region for alignment relative to a punctum of a patient.

43. The catheter of claim 41 wherein said inflatable member has a diameter when inflated of 2-5 mm.

44. The catheter of claim 43 wherein said inflatable member has a length of 15-30 mm.

45. The catheter of claim 43 wherein said second marker is located 9-11 mm from said proximal end of said center region and said catheter further includes a third visually perceivable marker located 14-16 mm proximal to said proximal end of said center region.

46. The catheter of claim 34 wherein a first visually perceivable marker is spaced 9-16 mm proximal to said distal end of said center region for alignment relative to a punctum of the patient for dilatation of a canaliculus.

47. The catheter of claim 46 wherein said inflatable member has a diameter of 2-4 mm when inflated.

48. The catheter of claim 34 wherein said catheter body defines a first lumen for inflating said inflatable member and a second lumen for receiving a guidewire.

49. The catheter of claim 34 wherein said catheter body has a distal segment and a proximal segment, the distal segment being more flexible than the proximal segment.

50. The catheter of claim 49 wherein the distal segment includes a slender, flexible wire.

51. The catheter of claim 34 further including a lubricious coating disposed on said catheter body to facilitate inserting said catheter into the lacrimal system.

52. A catheter for dilating an obstructed portion of the lacrimal system of a patient, comprising:

a catheter body having a proximal end and a distal end;

an inflatable member formed of noncompliant material and disposed proximate to the distal end of said catheter body, said inflatable member having when inflated a center region, a distal tapered region and a proximal tapered region, said distal region attached to a distal end of said center region and said proximal tapered region attached to a proximal end of said center region;

at least one visually perceivable dilatation marker disposed within said center region of said inflatable member for enabling alignment of said inflatable member with the obstructed portion of the lacrimal system to be dilated; and

at least one visually perceivable insertion marker spaced from one of said distal end and said proximal end of said center region for enabling positioning of said inflatable member relative to an opening into the lacrimal system.