Devices and methods for glaucoma treatment

• US 10,485,701 B2
• Filed: 03/20/2017
• Issued: 11/26/2019
• Est. Priority Date: 04/08/2002
• Status: Expired due to Term

• Current Assignee: Glaukos Corporation
• Original Assignee: Glaukos Corporation
• Inventors: Haffner, David Steven, Smedley, Gregory T., Tu, Hosheng, Burns, Thomas W.
• Primary Examiner(s): Rodjom, Katherine M
• Application Number:
  US15/464,113
• Publication Number:
  US 20180036172A1
• Time in Patent Office: 981 Days
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• 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

Abstract

Intraocular stents and applicators are disclosed for treating glaucoma. The stents are configured to extend between the anterior chamber of the eye and Schlemm'"'"'s canal for enhancing outflow of aqueous from the anterior chamber so as to reduce intraocular pressure. The stents can have features for anchoring the stent into Schlemm'"'"'s canal as well as preventing the walls of Schlemm'"'"'s canal from closing the outlet of the stents. The applicators can be steerable so as to make implantation easier. Additionally, the applicators can be configured to hold a plurality of stents so that multiple stents can be implanted through one incision without removing the applicator from the incision between serial implantations.

Claims

1. An instrument for delivering ocular implants for treating an ophthalmic condition and dispensing the ocular implants through a wall of a Schlemm'"'"'s canal of an eye, the instrument comprising:

an injection sheath defining a lumen and comprising a distal stent-holding section, the distal stent-holding section sized to be introduced into the eye through an incision in the eye;

a plurality of ocular implants positioned in the lumen, each of said implants comprising a proximal head, a distal tapered base portion, and an intermediate waist portion extending an entire length between the proximal head and the distal tapered base portion, each of said implants sized to bypass a trabecular mesh with the proximal head exposed to an anterior chamber of the eye and the distal tapered base portion exposed to Schlemm'"'"'s canal, the waist portion being substantially cylindrical and having a maximum outer dimension that is smaller than an outer dimension of a distal end of the proximal head and smaller than an outer dimension of a proximal end of the distal tapered base portion, wherein the outer dimension of the distal tapered base portion tapers in a direction longitudinally away from the waist portion, and wherein the proximal end of the distal tapered base portion comprises an edge surface configured to extend perpendicularly from an outer surface of the waist portion; and

a trocar extending through each of the plurality of implants, wherein a distal tip of said trocar is sufficiently sharp to cut through said wall of said Schlemm'"'"'s canal.

2. The instrument of claim 1, further comprising:

a handle attached to the injection sheath;

a stent delivery button disposed on the handle; and

a stent discharge mechanism, wherein the stent delivery button is configured to cause the stent discharge mechanism to discharge, from the insertion sheath, one implant at a time.

3. The instrument of claim 2, wherein the stent discharge mechanism slides the implant off of the trocar.

4. The instrument of claim 2, wherein the stent discharge mechanism comprises a pusher adapted for evenly pushing each of the plurality of implants, one at a time, out of the insertion sheath.

5. The instrument of claim 4, wherein the pusher is connected with the stent delivery button, the stent discharge mechanism being configured to move the pusher a predetermined distance each time the stent delivery button is pressed.

6. The instrument of claim 2, further comprising a holding member disposed between a pair of immediately adjacent implants of the plurality of implants.

7. The instrument of claim 6, wherein the holding member is elastically deformable.

8. The instrument of claim 6, wherein the holding member is disposed on the trocar.

9. The instrument of claim 1, wherein each of said implants further comprises a central lumen and one or more side-ports, the central lumen extending from a proximal-most surface of the proximal head to a distal-most surface of the distal tapered base portion, each of the one or more side-ports extending between the central lumen and an outer surface of the distal tapered base portion.

10. The instrument of claim 9, wherein the trocar extends through the central lumen of each of said implants.

11. The instrument of claim 1, wherein the implants are arranged in series within the lumen.

12. The instrument of claim 1, wherein each of the plurality of implants is slidably mounted on the trocar.

13. An instrument for delivering ocular implants for treating an ophthalmic condition and dispensing the ocular implants through a wall of a Schlemm'"'"'s canal of an eye, the instrument comprising:

an insertion sheath defining a lumen, a distal portion of the insertion sheath sized to be introduced into the eye through an incision in the eye;

a trocar disposed in said lumen, said trocar comprising a distal tip having a cutting end sufficiently sharp to cut through said wall of said Schlemm'"'"'s canal; and

a plurality of biocompatible ocular implants positioned in the lumen and mounted on the trocar, each of said implants comprising a head, a base portion, and a waist portion extending an entire length between the head and the base portion, each of said implants sized to bypass a trabecular mesh with the head exposed to an anterior chamber of the eye and the base portion exposed to Schlemm'"'"'s canal, wherein a maximum outer dimension of the waist portion is smaller than an outer dimension of an immediately-adjacent portion of the head and smaller than an outer dimension of an immediately-adjacent portion of the base portion, and wherein a proximal end of the base portion comprises an edge surface configured to extend perpendicularly from an outer surface of the waist portion, each of the plurality of implants being mounted on the trocar such that the outer dimension of the base portion tapers toward the distal tip of the trocar.

14. The instrument of claim 13, further comprising:

a handle attached to the injection sheath;

a stent delivery button disposed on the handle; and

a stent discharge mechanism, wherein the stent delivery button is configured to cause the stent discharge mechanism to discharge, from the insertion sheath, one implant at a time.

15. The instrument of claim 14, wherein the stent discharge mechanism slides the implant off of the trocar.

16. The instrument of claim 14, wherein the stent discharge mechanism comprises a pusher adapted for evenly pushing each of the plurality of implants, one at a time, out of the insertion sheath.

17. The instrument of claim 16, wherein the pusher is connected with the stent delivery button, the stent discharge mechanism being configured to move the pusher a predetermined distance each time the stent delivery button is pressed.

18. The instrument of claim 17, further comprising a holding member disposed between a pair of immediately adjacent implants of the plurality of implants.

19. The instrument of claim 18, wherein the holding member is elastically deformable.

20. The instrument of claim 18, wherein the holding member is disposed on the trocar.

21. The instrument of claim 13, wherein each of said implants further comprises a central lumen and one or more side-ports, the central lumen extending from a proximal-most surface of the head to a distal-most surface of the base portion, each of the one or more side-ports extending between the central lumen and an outer surface of the base portion.

22. The instrument of claim 21, wherein the trocar extends through the central lumen of each of said implants.

23. The instrument of claim 13, wherein the implants are positioned in series within the lumen.

24. The instrument of claim 13, wherein each of the plurality of implants is slidably mounted on the trocar.

25. An instrument for delivering ocular implants for treating an ophthalmic condition and dispensing the ocular implants through a wall of a Schlemm'"'"'s canal of an eye, the instrument comprising:

an injection sheath defining a lumen, a distal portion of said injection sheath sized to be introduced into an anterior chamber of the eye;

a trocar disposed in said lumen, said trocar comprising a distal tip being sufficiently sharp to cut through said wall of said Schlemm'"'"'s canal; and

a plurality of ocular implants mounted on the trocar and positioned in the distal portion of the injection sheath, each of said implants comprising a single tapered base portion having an outer surface that tapers toward the distal tip of the trocar, each of said implants further comprising a waist portion that extends proximally away from a proximal end of the tapered base portion, a maximum outer dimension of the waist portion being smaller than an outer dimension of the proximal end of the tapered base portion, each of said implants further comprising a head portion that extends proximally away from a proximal end of the waist portion, the maximum outer dimension of the waist portion being smaller than an outer dimension of the distal end of the head portion, the proximal end of the tapered base portion comprising an edge surface configured to extend perpendicularly from an outer surface of the waist portion, each of said implants sized to bypass a trabecular mesh with the head portion exposed to an anterior chamber of the eye and the tapered base portion exposed to Schlemm'"'"'s canal.

26. The instrument of claim 25, wherein each of said implants further comprises a central lumen extending from a proximal-most surface of the head portion to a distal-most surface of the tapered base portion.

27. The instrument of claim 26, wherein each of said implants further comprises one or more side-ports extending from the central lumen to the outer surface of the tapered base portion.

28. The instrument of claim 25, wherein the trocar extends through the central lumen of each of said implants.

29. The instrument of claim 25, wherein the implants are positioned in series within the lumen.

30. The instrument of claim 25, wherein each of the plurality of implants is slidably mounted on the trocar.

31. The instrument of claim 25, further comprising:

a handle attached to the injection sheath;

a stent delivery button disposed on the handle; and

a stent discharge mechanism, wherein the stent delivery button is configured to cause the stent discharge mechanism to discharge, from the insertion sheath, one implant at a time.

32. The instrument of claim 31, wherein the stent discharge mechanism slides the implant off of the trocar.

33. The instrument of claim 31, wherein the stent discharge mechanism comprises a pusher adapted for evenly pushing each of the plurality of implants, one at a time, out of the insertion sheath.

34. The instrument of claim 33, wherein the pusher is connected with the stent delivery button, the stent discharge mechanism being configured to move the pusher a predetermined distance each time the stent delivery button is pressed.

35. The instrument of claim 34, further comprising a holding member disposed between a pair of immediately adjacent implants of the plurality of implants.

36. The instrument of claim 35, wherein the holding member is elastically deformable.

37. The instrument of claim 35, wherein the holding member is disposed on the trocar.