LACRIMAL IMPLANTS AND RELATED METHODS

• US 20100274204A1
• Filed: 02/23/2010
• Published: 10/28/2010
• Est. Priority Date: 02/23/2009
• Status: Active Grant

• Current Assignee: Mati Therapeutics, Inc
• Original Assignee: QLT Plug Delivery, Inc.
• Inventors: Rubinchik, Valery, RAPACKI, Alan R., Kjellbotn, Charles Richard
• Granted Patent: US 10,238,535 B2
• Time in Patent Office: Days
• US Class Current: 604/285
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 9/00772 Apparatus for restoration of tear ducts
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants

Abstract

Lacrimal implants and related methods providing secure, wedgable retention within a lacrimal punctum and associated canaliculus of an eye are disclosed. The lacrimal implants can comprise an implant body configured for at least partial insertion through the lacrimal punctum and into the canaliculus. The implant body can include first and second portions, and can extend from a proximal end of the first portion defining a longitudinal proximal axis to a distal end of the second portion defining a longitudinal distal axis. The implant body can be configured such that, when implanted using an integral dilator, an angled intersection exists between the proximal and distal axes. In this way, at least a portion of the implant body can be biased against at least a portion of the lacrimal canaliculus located at or more distal to a canalicular curvature, thereby retaining an implanted position of the lacrimal implant using anatomical structures.

Claims

1. A lacrimal implant insertable into a lacrimal canaliculus, comprising:

an implant body, including first and second portions, the implant body extending from a proximal end of the first portion to a distal end of the second portion;

the proximal end of the first portion defining a longitudinal proximal axis and including a retainment projection laterally protruding non-equidistantly around its circumference;

the distal end of the second portion defining a longitudinal distal axis; and

the implant body configured such that, when implanted in the lacrimal canaliculus, an angled intersection exists between the proximal axis and the distal axis for biasing at least a portion of the implant body against at least a portion of the lacrimal canaliculus located at or more distal to a canalicular curvature.

2. The lacrimal implant of claim 1, wherein a proximal end of the retainment projection of the first portion laterally protrudes outward in a non-equal lateral distance about its circumference and tapers down to an outer diameter of a distal end of the first portion.

3. The lacrimal implant of claim 2, comprising a graspable projection extending at least partially from the proximal end of the first portion, the graspable projection configured to seat against or near a lacrimal punctum when the implant body is implanted;

and

wherein the proximal end of the retainment projection of the first portion includes a perimeter numerically about equal to a perimeter of the graspable projection.

4. The lacrimal implant of claim 2, wherein the proximal end of the retainment projection of the first portion protrudes outward in opposite directions on opposing first and second sides without protruding outwardly from the outer diameter on opposing third and fourth sides.

5. The lacrimal implant of claim 1, further comprising one or more therapeutic agents.

6. The lacrimal implant of claim 5, wherein the one or more therapeutic agents are provided in a drug insert at least partially positioned in the first portion, the drug insert configured to deliver a sustained release of the one or more therapeutic agents.

7. (canceled)

8. A lacrimal implant insertable into a lacrimal canaliculus, comprising:

an implant body, including first and second portions, the implant body extending from a proximal end of the first portion to a distal end of the second portion;

the proximal end of the first portion defining a longitudinal proximal axis;

the distal end of the second portion defining a longitudinal distal axis and including a retainment projection laterally protruding around its circumference, the retainment projection including an outward lateral step at one of a proximal end of the retainment projection or a distal end of the retainment projection; and

the implant body configured such that, when implanted in the lacrimal canaliculus, an angled intersection exists between the proximal axis and the distal axis for biasing at least a portion of the implant body against at least a portion of the lacrimal canaliculus located at or more distal to a canalicular curvature.

9. The lacrimal implant of claim 8, wherein the lateral step extends laterally outward in a direction perpendicular from a direction in which the second portion extends, the lateral step being greater than or equal to about 0.14 mm.

10. The lacrimal implant of claim 8, wherein the lateral step is positioned at the proximal end of the retainment projection and tapers toward an outer diameter of the second portion at the distal end of the retainment projection.

11. The lacrimal implant of claim 10, wherein the distal end of the retainment projection includes an integral dilator to facilitate implantation of the implant body into the lacrimal canaliculus.

12. The lacrimal implant of claim 8, further comprising one or more therapeutic agents.

13. The lacrimal implant of claim 12, wherein the one or more therapeutic agents are provided in a drug insert at least partially positioned in the first portion, the drug insert configured to deliver a sustained release of the one or more therapeutic agents.

15. The lacrimal implant of claim 13, wherein the drug insert comprises at least about 81 micrograms of the one or more therapeutic agents.

14. (canceled)

16. (canceled)

17. A lacrimal implant for insertion into a lacrimal canaliculus, comprising:

an implant body non-linearly extending from a proximal end portion positionable within a vertical section of the lacrimal canaliculus to a distal end portion positionable within a horizontal section of the lacrimal canaliculus and having an intermediate portion therebetween;

the intermediate portion partially extending in a first direction toward the proximal end portion and partially extending in a second direction toward the distal end portion; and

wherein the intermediate portion includes a recess storing an expandable material, the expandable material configured for partially expanding in a third direction, substantially opposite the second direction, toward a lacrimal canaliculus ampulla when the implant body is implanted in the lacrimal canaliculus.

18. The lacrimal implant of claim 17, wherein the expandable material includes hydrogel.

19. The lacrimal implant of claim 17, wherein the expandable material partially expands laterally, relative to the second direction, when the implant body is implanted, the lateral expansion urging one or more surrounding portions of the implant body outward against a wall of the lacrimal canaliculus.

20. The lacrimal implant of claim 17, wherein at least one of the proximal end portion or the distal end portion comprises at least one intermediately-disposed retainment projection having a cross-sectional size greater than an adjacent implant body portion.

21. The lacrimal implant of claim 17, further comprising one or more therapeutic agents.

22. The lacrimal implant of claim 21, wherein the one or more therapeutic agents are provided in a drug insert at least partially positioned in the proximal end portion, the drug insert including at least one exposed surface configured to deliver a sustained release of the one or more therapeutic agents.

23. (canceled)

24. A lacrimal implant insertable into a lacrimal canaliculus, comprising:

an implant body, including first and second portions, the implant body extending from a proximal end of the first portion to a distal end of the second portion;

the proximal end of the first portion defining a longitudinal proximal axis and including a retainment projection laterally protruding around its circumference;

the distal end of the second portion defining a longitudinal distal axis;

the retainment projection including an outward lateral step at a proximal end thereof and tapering directly into the second portion; and

the implant body configured such that, when implanted in the lacrimal canaliculus, an angled intersection exists between the proximal axis and the distal axis for biasing at least a portion of the implant body against at least a portion of the lacrimal canaliculus located at or more distal to a canalicular curvature.

25. The lacrimal implant of claim 24, wherein a length of the retainment projection is about 0.96 mm or more.

26. The lacrimal implant of claim 24, wherein a distal end of the retainment projection includes an integral dilator to facilitate implantation of the implant body into the lacrimal canaliculus.

27. The lacrimal implant of claim 24, further comprising one or more therapeutic agents.

28. The lacrimal implant of claim 27, wherein the one or more therapeutic agents are provided in a drug insert at least partially positioned in the first portion, the drug insert configured to deliver a sustained release of the one or more therapeutic agents.

29. The lacrimal implant of claim 28, wherein the drug insert is positioned within a first cavity of the first portion, the first cavity having a diameter at least about 0.56 mm.

30. The lacrimal implant of claim 29, wherein the drug insert comprises at least about 81 micrograms of the one or more therapeutic agents.

31-51. -51. (canceled)