Lacrimal filler

• US 20110066138A1
• Filed: 04/14/2009
• Published: 03/17/2011
• Est. Priority Date: 04/14/2009
• Status: Active Grant

• Current Assignee: Fezza Family Properties, LLC
• Original Assignee: Fezza Family Properties, LLC
• Inventors: Fezza, John
• Granted Patent: US 8,979,821 B2
• Time in Patent Office: Days
• US Class Current: 604/521
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 9/00772 Apparatus for restoration of tear ducts
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61L 24/0015 Medicaments; Biocides
• CPC Class Codes: A61L 24/08 Polysaccharides A61L24/043 takes precedence
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions

Abstract

A biomaterial mass is inserted through a punctum into a canaliculus in the lacrimal outflow system with a syringe. The mass has an outer cross section that is less than the inner cross section of the canaliculus. The mass absorbs liquid to swell to form a lacrimal filler or sealing mechanism. The lacrimal filler has an external cross section that conforms to the internal cross section of the canaliculus and a soft outer surface relative to the surrounding tissues to prevent erosion of the canaliculus lining. The lacrimal filler forms an occlusion that prevents the outflow of liquid through the lacrimal outflow system to retain tears within the eye to maintain eye lubrication and wetness. The mass and syringe are provided in kit with a rubber stopper and, optionally, a punctal dilator, an injecting catheter, and an enzyme for dissolving or degrading the lacrimal filler at a later time.

Claims

1. An apparatus for treating dry eyes comprising:

a biomaterial mass for inserting into a canaliculus in the lacrimal outflow system, said biomaterial mass having an outer cross section less than the inner cross section of the canaliculus,

said biomaterial mass absorbing liquid within the canaliculus to swell to form a lacrimal filler to partially seal the canaliculus,

said lacrimal filler having an external cross section conforming to the internal cross section of the canaliculus and a soft outer surface relative to the surrounding tissues to prevent erosion of the canaliculus lining, and

said lacrimal filler forming an occlusion to prevent the outflow of liquid through the lacrimal outflow system to retain tears within the eye to maintain eye lubrication and wetness.

2. An apparatus as set forth in claim 1 in which:

said biomaterial mass include polysaccharides.

3. An apparatus as set forth in claim 2 in which:

said polysaccharides include glycosaminoglycans.

4. An apparatus as set forth in claim 3 in which:

said glycosaminoglycans include hyaluronic acid.

5. An apparatus as set forth in claim 4 in which:

said biomaterial mass includes hyaluronic acid in a form selected from the group consisting of hyaluronic acid crystals, hyaluronic acid crystals suspended in hyaluronic acid liquid, hyaluronic acid gel, hyaluronic acid gel particles with hyaluronic acid solid particles, and hyaluronic acid solid particles.

6. An apparatus as set forth in claim 4 which includes:

said biomaterial mass being suspended in a solution having a hyaluronic acid concentration of between 1 mg/ml and 100 mg/ml prior to insertion into the canaliculus.

7. An apparatus as set forth in claim 6 which includes:

said biomaterial mass being suspended in a solution having a hyaluronic acid concentration of between 15 mg/ml and 25 mg/ml prior to insertion into the canaliculus.

8. An apparatus as set forth in claim 7 which includes:

said biomaterial mass being suspended in a solution having a hyaluronic acid concentration of about 22 mg/ml prior to insertion into the canaliculus.

9. An apparatus as set forth in claim 4 which includes:

said hyaluronic acid having a degree of crosslinking ranging from 0% to 100% crosslinking.

10. An apparatus as set forth in claim 9 which includes:

said hyaluronic acid having a degree of crosslinking ranging from 10% to 100% crosslinking.

11. An apparatus as set forth in claim 10 which includes:

said hyaluronic acid having a degree of crosslinking ranging from 60% to 95% crosslinking.

12. An apparatus as set forth in claim 1 which includes:

said lacrimal filler being removable from the canaliculus with an enzyme.

13. An apparatus as set forth in claim 4 which includes:

said lacrimal filler being removeable from the canaliculus with hyaluronidase enzyme.

14. An apparatus as set forth in claim 1 in which:

said lacrimal filler includes a drug for treating a condition.

15. An apparatus as set forth in claim 14 which includes:

said lacrimal filler dissolves at a predetermined rate to deliver said drug to the eye.

16. An apparatus as set forth in claim 15 which includes:

said drug includes a drug selected from the group consisting of a drug for treating glaucoma, a drug for treating allergies, steroids, and antibiotics.

17. A kit for treating dry eyes comprising:

a syringe,

a biomaterial mass,

said syringe injecting said biomaterial mass into a canaliculus in the lacrimal outflow system to absorb liquid within the canaliculus and swell to conform the outer surface of the mass to the inner surface of the canaliculus to form a sealing mechanism for sealing the canaliculus at least partially,

said sealing mechanism outer surface being sufficiently soft relative to the inner surface of the canaliculus to prevent the sealing mechanism outer surface from eroding the canaliculus lining, and

said sealing mechanism forming an occlusion to prevent the outflow of liquid through the lacrimal outflow system to retain tears within the eye to maintain eye lubrication and wetness.

18. A kit as set forth in claim 17 in which:

said biomaterial mass includes polysaccharides.

19. A kit as set forth in claim 18 in which:

said polysaccharides include glycosaminoglycans.

20. A kit as set forth in claim 19 in which:

said glycosaminoglycans include hyaluronic acid.

21. A kit as set forth in claim 20 which includes:

said biomaterial mass having hyaluronic acid in a form selected from the group consisting of hyaluronic acid crystals, hyaluronic acid crystals suspended in hyaluronic acid liquid, hyaluronic acid gel, hyaluronic acid gel particles with hyaluronic acid solid particles, and hyaluronic acid solid particles.

22. A kit as set forth in claim 20 which includes:

said biomaterial mass being suspended in a solution having a hyaluronic acid concentration of between 1 mg/ml and 100 mg/ml.

23. A kit as set forth in claim 22 which includes:

said biomaterial mass being suspended in a solution having a hyaluronic acid concentration of between 15 mg/ml and 25 mg/ml.

24. A kit as set forth in claim 23 which includes:

said biomaterial mass being suspended in a solution having a hyaluronic acid concentration of about 22 mg/ml.

25. A kit as set forth in claim 20 which includes:

said hyaluronic acid having a degree of crosslinking ranging from 0% to 100% crosslinking.

26. A kit as set forth in claim 25 which includes:

said hyaluronic acid having a degree of crosslinking ranging from 10% to 100% crosslinking.

27. A kit as set forth in claim 26 which includes:

said hyaluronic acid having a degree of crosslinking ranging from 60% to 95% crosslinking.

28. A kit as set forth in claim 17 in which:

said syringe includes a lacrimal injector.

29. A kit as set forth in claim 17 which includes:

a punctal dilator for dilating the puncta to facilitate insertion of said syringe therein.

30. A kit as set forth in claim 17 which includes:

an enzyme for dissolving said sealing mechanism.

31. A kit as set forth in claim 30 which includes:

said enzyme being hyaluronidase.

32. A kit as set forth in claim 17 in which:

said sealing mechanism includes a drug for treating a condition.

33. A kit as set forth in claim 32 in which:

said sealing mechanism has an outer surface that dissolves at a predetermined rate to deliver said drug.

34. A kit as set forth in claim 33 in which:

said drug includes a drug selected from the group consisting of a drug for treating glaucoma, a drug for treating allergies, steroids, and antibiotics.

35. A method for treating dry eyes comprising the steps of:

inserting a biomaterial mass into a canaliculus in the lacrimal outflow system,

absorbing liquid with the biomaterial mass in the canaliculus to swell to form a soft seal within the canaliculus that does not erode the inner lining of the canaliculus, sealing the canaliculus with the soft seal at least partially, and

preventing the outflow of liquid through the lacrimal outflow system with the soft seal to retain tears within the eye to maintain eye lubrication and wetness.

36. A method as set forth in claim 35 which includes:

inserting a biomaterial mass having polysaccharides into a canaliculus in the lacrimal outflow system.

37. A method as set forth in claim 36 which includes:

inserting a biomaterial mass having glycosaminoglycans into the canaliculus in the lacrimal outflow system.

38. A method as set forth in claim 37 which includes:

inserting a biomaterial mass having hyaluronic acid into the canaliculus in the lacrimal outflow system.

39. A method as set forth in claim 38 which includes:

inserting a biomaterial mass having hyaluronic acid in a form selected from the group consisting of hyaluronic acid crystals, hyaluronic acid crystals suspended in hyaluronic acid liquid, hyaluronic acid gel, hyaluronic acid gel particles with hyaluronic acid solid particles, or hyaluronic acid solid particles into the canaliculus in the lacrimal outflow system.

40. A method as set forth in claim 38 which includes:

inserting a biomaterial mass having hyaluronic acid suspended in a solution having a hyaluronic acid concentration of between the 1 mg/ml and 100 mg/ml into the canaliculus in the lacrimal outflow system.

41. A method as set forth in claim 40 which includes:

inserting a biomaterial mass having hyaluronic acid suspended in a solution having a hyaluronic acid concentration of between the 15 mg/ml and 25 mg/ml into the canaliculus in the lacrimal outflow system.

42. A method as set forth in claim 41 which includes:

inserting a biomaterial mass having hyaluronic acid suspended in a solution having a hyaluronic acid concentration of about 22 mg/ml into the canaliculus in the lacrimal outflow system.

43. A method as set forth in claim 38 which includes:

inserting a biomaterial mass having hyaluronic acid having a degree of crosslinking ranging from 0% to 100% crosslinking into the canaliculus in the lacrimal outflow system.

44. A method as set forth in claim 43 which includes:

inserting a biomaterial mass having hyaluronic acid having a degree of crosslinking ranging from 10% to 100% crosslinking into the canaliculus in the lacrimal outflow system.

45. A method as set forth in claim 44 which includes:

inserting a biomaterial mass having hyaluronic acid having a degree of crosslinking ranging from 60% to 95% crosslinking into the canaliculus in the lacrimal outflow system.

46. A method as set forth in claim 35 which includes:

injecting the biomaterial mass into the canaliculus with a syringe to insert the biomaterial mass into the lacrimal outflow system.

47. A method as set forth in claim 46 which includes:

injecting the biomaterial mass into the canaliculus with a lacrimal injector to insert the biomaterial mass into the lacrimal outflow system.

48. A method as set forth in claim 46 which includes:

inserting a puncta dilator into a puncta, and

dilating the puncta to facilitate insertion of the syringe and a catheter into the canaliculus.

49. A method as set forth in claim 35 which includes:

unsealing the canaliculus with an enzyme.

50. A method as set forth in claim 39 which includes:

unsealing the canaliculus with hyaluronidase.

51. A method as set forth in claim 35 which includes:

dissolving the outer surface of the seal at a predetermined rate to deliver a drug.

52. A method as set forth in claim 51 which includes:

delivering a drug selected from the group consisting of a drug for treating glaucoma, a drug for treating allergies, steroids, and antibiotics from the seal into the canaliculus.