System and method for delivering multiple ocular implants

• US 9,554,940 B2
• Filed: 03/14/2013
• Issued: 01/31/2017
• Est. Priority Date: 03/26/2012
• Status: Active Grant

• Current Assignee: Glaukos Corporation
• Original Assignee: Glaukos Corporation
• Inventors: Haffner, David Steven, Cogger, John Joseph, Kalina, Charles Raymond Jr., Crimaldi, Douglas Daniel
• Primary Examiner(s): NGUYEN, TUAN VAN
• Application Number:
  US13/830,100
• Publication Number:
  US 20130253528A1
• Time in Patent Office: 1,419 Days
• Field of Search: 606/107, 604/7, 604/8, 604/9, 604/10
• US Class Current: 1/1
• CPC Class Codes: A61F 2/14 Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
• CPC Class Codes: A61F 2/148 Implantation instruments specially adapted therefor
• CPC Class Codes: A61F 2250/009 for single use, e.g. having means for preventing re-use
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: F04C 2270/0421 Controlled or regulated

Abstract

Systems and methods for delivering multiple ocular implants to reduce intraocular pressure are disclosed. The ocular implants can be implanted at multiple sites within a single human eye without requiring removal of the delivery apparatus from the eye. A system for delivering multiple ocular implants can include at least two implants preloaded within a delivery device and configured to be implanted within the eye, a metering device configured to transfer energy to the implants for delivery at selected locations within the eye, wherein the metering device is configured to meter a variable amount of energy for each implant delivery event in the eye. The system can further include an injector mechanism configured to serially engage and drive each of the implants.

Claims

1. A method of treating an ocular disorder, comprising:

advancing an insertion tube assembly of an injector instrument loaded with a plurality of implants through an incision in an eye;

wherein said insertion tube assembly comprises a trocar, an insertion tube, and a slot on a distal end of said insertion tube;

piercing eye tissue with said insertion tube assembly of said injector instrument;

propelling a first implant, loaded within said injector instrument, into eye tissue;

viewing an implantation depth of said first implant within eye tissue through said slot; and

adjusting said insertion tube assembly of the injector instrument based on said implantation depth of said first implant.

2. The method of claim 1, the method further comprising determining an amount of under-implantation based on said implantation depth.

3. The method of claim 2, wherein adjusting said insertion tube assembly comprises increasing pressure on said eye tissue based on said amount of under-implantation.

4. The method of claim 3, wherein said second implant is propelled at substantially the same velocity as said first implant.

5. The method of claim 3, wherein the method can be performed without removing the insertion tube assembly from the eye.

6. The method of claim 5, wherein adjusting said insertion tube assembly comprises decreasing pressure on said eye tissue based on said amount of over-implantation.

7. The method of claim 6, wherein said second implant is propelled at substantially the same velocity as said first implant.

8. The method of claim 6, wherein the method can be performed without removing the insertion tube assembly from the eye.

9. The method of claim 2, the method further comprising propelling a second implant, loaded within said injector instrument, after increasing said pressure on said eye tissue.

10. The method of claim 1, the method further comprising determining an amount of over-implantation based on said implantation depth.

11. The method of claim 10, the method further comprising propelling a second implant, loaded within said injector instrument, after decreasing said pressure on said eye tissue.

12. The method of claim 1, wherein the method further comprises penetrating external eye tissue to create said incision.

13. The method of claim 12, wherein penetrating external eye tissue comprises penetrating external eye tissue with a retractable needle on said injector instrument.

14. The method of claim 13 wherein at least a portion of said needle comprises a low friction coating.

15. The method of claim 14, wherein at least a portion of said needle comprises a hydrophobic coating.

16. The method of claim 14, wherein at least a portion of said needle comprises a hydrophilic coating.

17. The method of claim 1, wherein when said first implant is implanted into eye tissue, an inlet of said first implant is positioned in an anterior chamber of the eye and an outlet of said first implant is positioned in a physiologic outflow pathway of said eye to allow fluid flow from said anterior chamber through said first implant to the physiologic outflow pathway.

18. The method of claim 1, wherein when said second implant is implanted into eye tissue, an inlet of said second implant is positioned in an anterior chamber of the eye and an outlet of said second implant is positioned in a physiologic outflow pathway of said eye to allow fluid flow from said anterior chamber through said second implant to the physiologic outflow pathway.

19. The method of claim 1, wherein the insertion tube assembly further comprises a driving member.

20. The method of claim 19, wherein the driving member comprises a collet.

21. An implant delivery apparatus for treating an ocular disorder, comprising:

a housing;

an insertion tube extending from the housing, the insertion tube comprising a hollow tubular body, an axial opening at a distal end of the hollow tubular body and a slot on a side of the hollow tubular body,

wherein said slot extends to the distal end of said hollow tubular body;

a trocar at least partially housed within said insertion tube, wherein said trocar is attached to the housing so as to not move relative to the housing;

a slot on a distal end of said insertion tube;

at least two implants loaded within said insertion tube assembly on said trocar of said implant delivery apparatus; and

an implant advancement member at least partially housed within said insertion tube,

wherein said slot is located on a side of said hollow tubular body and extends to the distal end of said insertion tube;

wherein said slot allows a user to view at least one implant of the at least two implants loaded on said trocar; and

wherein said insertion tube assembly is configured to pierce eye tissue.

22. The implant delivery apparatus of claim 21, wherein said slot has a width ranging from about 0.002 inches to about 0.045 inches.

23. The implant delivery apparatus of claim 21, wherein said slot has a length ranging from about 0.002 inches to about 1.5 inches.

24. The implant delivery apparatus of claim 21, wherein the implant delivery apparatus further comprises a seal configured to reduce passage of aqueous humor through the implant delivery apparatus.

25. The implant delivery apparatus of claim 24, wherein the seal is placed on at least an inner surface of the insertion tube or an outer surface of the implant advancement member.

26. The implant delivery apparatus of claim 25, wherein at least a portion of said retractable piercing member comprises a hydrophobic coating.

27. The implant delivery apparatus of claim 25, wherein at least a portion of said retractable piercing member comprises a hydrophilic coating.

28. The implant delivery apparatus of claim 21, wherein the implant delivery apparatus additionally comprises a retractable piercing member configured to create an incision in external eye tissue.

29. The implant delivery apparatus of claim 21, wherein each of said at least two implants comprises an inlet portion configured to be positioned in an anterior chamber of an eye and an outlet portion configured to be positioned in a physiologic outflow pathway of said eye.

30. The implant delivery apparatus of claim 21, wherein a width of said slot tapers from a distal-most end of the slot to a proximal-most end of the slot.

31. The implant delivery apparatus of claim 21, wherein said slot is located on a single side of said hollow tubular body.

32. The implant delivery apparatus of claim 21, wherein said trocar is configured to form an opening in ocular tissue.

33. The implant delivery apparatus of claim 21, wherein said trocar is fixed relative to the implant advancement member.

34. An implant delivery apparatus for treating an ocular disorder, comprising:

an insertion tube assembly, comprising;

an insertion tube comprising a hollow tubular body, an axial opening at a distal end of the hollow tubular body and a slot on a side of the hollow tubular body,

a trocar at least partially housed within said insertion tube;

a slot on a distal end of said insertion tube;

at least two ocular drainage implants loaded on said trocar within an insertion tube assembly of said implant delivery apparatus, each of the at least two ocular drainage implants comprising an inlet, a plurality of outlets positioned at a distal portion of the ocular drainage implant, and a lumen extending between the inlet and the plurality of outlets; and

a retractable piercing member configured to create an incision in external eye tissue,

wherein said slot is located on a single side of said hollow tubular body and wherein a width of said slot tapers from a distal-most end of the slot to the proximal-most end of the slot, and

wherein said slot allows a user to view at least one of the ocular drainage implants loaded on said trocar.

35. The implant delivery apparatus of claim 34, wherein at least a portion of said retractable piercing member comprises a hydrophobic coating.

36. The implant delivery apparatus of claim 34, wherein at least a portion of said retractable piercing member comprises a hydrophilic coating.