Method and catheter for dilatation of the lacrimal system

• US 5,169,386 A
• Filed: 06/25/1990
• Issued: 12/08/1992
• Est. Priority Date: 09/11/1989
• Status: Expired due to Term

• Current Assignee: Atrion (Atrion Corporation)
• Original Assignee: Bruce B Becker
• Inventors: Becker, Bruce B., Berthiaume, William A.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US07/542,598
• Time in Patent Office: 897 Days
• Field of Search: 128/658, 128/656-657, 604/96-103, 604/264-265, 604/270, 604/281-282, 604/49, 606/192, 606/194
• 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 dilation catheter having an inflatable member and an element for retaining a curved shape, 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 the inflatable member is positioned in the obstructed portion. Insertion of the catheter is facilitated by mechanically imparting a curved shape to a distal portion of the catheter. 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 including;

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;

means, carried by the catheter body near the distal end of the catheter body, for retaining a curved shape after mechanical force is applied to it, the curved shape enabling the catheter to be more readily inserted through the lacrimal system to access the obstructed portion; 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.

2. The method of claim 1 in which inserting the catheter includes applying mechanical force to the means for retaining to impart a selected curved shape to the catheter.

3. The method of claim 1 further including initially passing a probe through the lacrimal system to determine a path between the first and second openings through the obstruction.

4. The method of claim 3 further including bending a distal portion of the probe to a selected curved shape to facilitate insertion through the lacrimal system.

5. The method of claim 4 further including bending a portion of the means for retaining so that the catheter assumes a curved shape substantially similar to the selected curved shape of the probe.

6. The method of claim 1 wherein the catheter is inserted through a punctum and associated canaliculus, and then through an ostium formed between the nose and the lacrimal sac, and 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.

7. The method of claim 6 wherein the inflatable member is translucent, a second visually perceivable marker is located beneath the inflatable member at a distance of 0-6 mm distal to the proximal end of the center region, and positioning further includes aligning the second marker relative to the ostium.

8. The method of claim 1 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.

9. The method of claim 8 wherein the inflatable member is translucent, a second visually perceivable marker is located beneath the inflatable member at a distance of 0-6 mm proximal to the distal end of the center region, and positioning further includes aligning the second marker relative to the ostium.

10. The method of claim 1 wherein the catheter is inserted through a punctum and associated canaliculus, and then through the nasolacrimal duct, and the inflatable member is translucent, a first visually perceivable marker is located beneath the inflatable member at a distance of 0-6 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.

11. The method of claim 10 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.

12. The method of claim 11 wherein the second marker is located 9-11 mm proximal to 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.

13. The method of claim 12 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.

14. The method of claim 1 wherein the catheter is inserted through a punctum and associated canaliculus for dilatation of the canaliculus, and 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.

15. The method of claim 1 wherein the provided catheter includes a lubricious coating to facilitate inserting the catheter into the lacrimal system.

16. The method of claim 15 further including topically applying the coating to the catheter body and the inflatable member.

17. 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 said 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

fixed means, carried by said catheter body and located only near said distal end of said catheter body, for retaining a permanent curved shape after mechanical force is applied to it, the curved shape enabling said catheter to be more readily inserted through the lacrimal system to access the obstructed portion.

18. The catheter of claim 17 in which said catheter body defines an inflation lumen having a distal opening communicating with said inflatable member to enable inflation and deflation of said inflatable member.

19. The catheter of claim 18 in which said fixed means for retaining occupies a distal portion of said inflation lumen without occluding said lumen.

20. The catheter of claim 19 in which said fixed means for retaining includes a metal wire attached to said catheter body distal to said distal opening of said inflation lumen.

21. The catheter of claim 17 in which said fixed means for retaining retains a curved shape after sufficient mechanical force is applied to exceed its elastic limit.

22. The catheter of claim 17 in which a distal portion of said catheter has a stiffness in flexure of between 14.2 to 21.4×

10⁶ pounds per square inch as measured on an Olsen Stiffness Tester according to ASTM D747-83.

23. The catheter of claim 17 in which the curved shape exhibits an angle of between one and thirty degrees.

24. The catheter of claim 17 in which said distal end of said catheter includes a rounded distal tip formed of cured adhesive.

25. The catheter of claim 17 in which said means for retaining is a metal element.

26. The catheter of claim 25 in which said metal element is a wire formed of stainless steel and said catheter body includes a hollow metal tube.

27. The catheter of claim 17 further including 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.

28. The catheter of claim 27 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.

29. The catheter of claim 28 wherein said inflatable member is translucent and a second visually perceivable marker is located beneath said inflatable member at a distance of 0-6 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.

30. The catheter of claim 29 in which said inflatable member has a diameter of 3-6 mm when inflated.

31. The catheter of claim 30 in which said inflatable member has a length of 5-10 mm.

32. The catheter of claim 27 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.

33. The catheter of claim 32 wherein said inflatable member is translucent and a second visually perceivable marker is located beneath said inflatable member at a distance of 0-6 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.

34. The catheter of claim 27 wherein said inflatable member is translucent and a first visually perceivable marker is located beneath said inflatable member a distance of 0-6 mm proximal to said distal end of said center region for alignment relative to the opening of the nasolacrimal duct into the nose.

35. The catheter of claim 34 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.

36. The catheter of claim 35 wherein said inflatable member has a diameter when inflated of 2-5 mm.

37. The catheter of claim 36 wherein said inflatable member has a length of 15-30 mm.

38. The catheter of claim 36 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.

39. The catheter of claim 34 wherein said inflatable member has a diameter of 2-4 mm when inflated.

40. The catheter of claim 27 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.

41. The catheter of claim 17 further including a lubricious coating disposed on said catheter body to facilitate inserting said catheter into the lacrimal system.

42. 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;

said catheter body defining an inflation lumen having a proximal opening near said proximal end of said catheter body and having a distal opening communicating with said inflatable member; and

fixed means, carried by said catheter body and located only near said distal end of said catheter body, for increasing the stiffness of said catheter body to resist kinking, while enabling said catheter body to be permanently bend to curved shape to enable said catheter to be more readily inserted through the lacrimal system to access the obstructed portion.

43. The catheter of claim 42 om which said fixed means for increasing the stiffness includes a metal element carried within a distal portion of said catheter body.

44. The catheter of claim 43 in which said metal element retains a selected curved shape after sufficient mechanical force is applied to it.

45. The catheter of claim 42 further including 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.

46. The catheter of claim 45 further including 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.