Implant delivery system and methods thereof for treating ocular disorders

• US 10,285,856 B2
• Filed: 02/06/2017
• Issued: 05/14/2019
• Est. Priority Date: 08/28/2001
• Status: Active Grant

• Current Assignee: Glaukos Corporation
• Original Assignee: Glaukos Corporation
• Inventors: Tu, Hosheng, Haffner, David Steven, Smedley, Gregory T., Niksch, Barbara A., Gharib, Morteza, Burns, Thomas W., Lindstrom, Richard
• Primary Examiner(s): Stransky, Katrina M
• Assistant Examiner(s): Mendoza, Michael
• Application Number:
  US15/425,839
• Publication Number:
  US 20170273829A1
• Time in Patent Office: 827 Days
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• 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 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 9/007 Methods or devices for eye surgery
• 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: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

Surgical methods and related medical devices for treating glaucoma are disclosed. The method comprises trabecular bypass surgery, which involves bypassing diseased trabecular meshwork with the use of a stent implant. The stent implant is inserted into an opening created in the trabecular meshwork by a piercing member that is slidably advanceable through the lumen of the stent implant for supporting the implant insertion. The stent implant is positioned through the trabecular meshwork so that an inlet end of the stent implant is exposed to the anterior chamber of the eye and an outlet end is positioned into fluid collection channels at about an exterior surface of the trabecular meshwork or up to the level of aqueous veins.

Claims

1. An applicator system for placing a trabecular stent into a trabecular meshwork of an eye, the applicator system comprising:

a generally cylindrical outer sheath comprising an opening at a distal-most end of the sheath and a sheath lumen that extends along a longitudinal axis;

a stent housed within the sheath lumen, the stent comprising a proximal end, a distal end, and a stent lumen that communicates between the proximal and distal ends;

a piercing member aligned with the longitudinal axis of the sheath and extending through the stent lumen, the piercing member comprising a piercing tip configured to extend distally beyond the opening at the distal-most end of the sheath during at least a portion of a stent delivery cycle of the applicator system that places the stent into the trabecular meshwork of the eye;

a plurality of stent-delivery elements disposed radially outward of the piercing member and being longitudinally movable relative thereto, the plurality of stent-delivery elements being spaced apart from one another and extending along a length of the longitudinal axis of the sheath, each of the plurality of stent-delivery elements comprising a distal end configured to contact the proximal end of the stent and to advance the stent along the piercing member as the stent-delivery elements move distally along the longitudinal axis of the sheath toward the opening at the distal-most end of the sheath; and

a deployment mechanism including an energy source configured to move the stent-delivery elements at least distally relative to the piercing member.

2. The applicator system of claim 1, wherein the energy source comprises a spring that stores mechanical energy.

3. The applicator system of claim 1, wherein the energy source comprises a solenoid.

4. The applicator system of claim 1, wherein the piercing tip is selected from the group consisting of a knife, a laser probe, a pointed guide member, a radiofrequency energy source, an ultrasonic energy source, a fiber optic laser, and a microwave energy source.

5. The applicator system of claim 1, wherein the piercing member is a pointed guide member.

6. An applicator system for placing a trabecular stent into a trabecular meshwork of an eye, the applicator system comprising:

an elongated tubular stent comprising a proximal inlet section, a distal outlet section, a medial section therebetween, and a lumen extending therethrough along a longitudinal axis, the stent being sized so that, when the medial section is disposed within the trabecular meshwork of the eye, at least a portion of the proximal inlet section is disposed in an anterior chamber of the eye and at least a portion of the distal outlet section is disposed in Schlemm'"'"'s canal;

an elongate sheath configured to retain the stent therein prior to the stent being implanted in the trabecular meshwork of the eye, the sheath comprising an opening at a distal-most end of the sheath;

a piercing member extending through the proximal inlet section, the lumen, and the distal outlet section of the stent at least prior to the stent being dispensed from the sheath, a distal end of the piercing member comprising a piercing tip configured to extend distally beyond the opening at the distal-most end of the sheath at least when dispensing the stent from the sheath;

a plurality of stent-delivery elements disposed radially outward of the piercing member, the stent-delivery elements being moveable distally and proximally in a reciprocating motion relative to the piercing member, the plurality of stent-delivery elements being spaced apart from one another and being generally aligned with the piercing member, each of the plurality of stent-delivery elements comprising a distal end configured to contact the proximal end of the stent and to move the stent along the piercing member as the stent-delivery elements move distally toward the opening at the distal-most end of the sheath; and

a deployment mechanism comprising an energy source adapted to move the stent-delivery elements at least in a distal direction.

7. The applicator system of claim 6, wherein an outer surface of the distal section of the stent tapers toward a distal-most end of the stent.

8. The applicator system of claim 6, wherein the distal section comprises a plurality of outlet ports in fluid communication with the lumen.

9. The applicator system of claim 6, wherein the inlet section comprises a lower surface and the distal section comprises an upper surface, the stent being sized so that the lower surface is seated within Schlemm'"'"'s canal when the lower surface is seated on an exterior surface of the trabecular meshwork.

10. The applicator of claim 6, wherein the energy source comprises a spring that stores mechanical energy.

11. The applicator of claim 6, wherein the energy source comprises a solenoid.

12. The applicator of claim 6, wherein the piercing tip is selected from the group consisting of a knife, a laser probe, a pointed guide member, a radiofrequency energy source, an ultrasonic energy source, a fiber optic laser, and a microwave energy source.

13. The applicator system of claim 6, wherein the piercing member is a pointed guide member.

14. The applicator system of claim 6, wherein the stent comprises one or more of a porous material, a hydrophilic material, a hydrophobic material, and a hydrogel.

15. The applicator system of claim 6, wherein the stent comprises a bioerodible material admixed with a drug suitable for treating glaucoma or other ophthalmology abnormalities.

16. The applicator system of claim 6, wherein the stent comprises a drug that is coated or loaded onto the stent.

17. An applicator for placing a trabecular stent into a trabecular meshwork of an eye, the applicator comprising:

a generally cylindrical outer sheath comprising an opening at a distal-most end of the sheath and further comprising a lumen that extends along a longitudinal axis;

a piercing member comprising a proximal portion and a piercing tip, the proximal portion disposed within the sheath and aligned with the longitudinal axis of the sheath, the piercing tip disposed distally beyond the opening at the distal-most end of the sheath during at least a portion of a delivery cycle of the applicator;

a plurality of stent-delivery elements disposed within the lumen, the stent-delivery elements being circumferentially spaced apart from one another and extending along a length of the longitudinal axis of the sheath, the stent-delivery elements being moveable distally and proximally in a reciprocating motion relative to the piercing member, each of the stent-delivery elements having a distal end configured to move a stent mounted on the piercing member along the piercing member as the stent-delivery element advances distally toward the opening at the distal-most end of the sheath; and

a deployment mechanism including an energy source configured to move the stent-delivery elements at least distally relative to the piercing member.

18. The applicator system of claim 17, wherein the plurality of stent-delivery elements includes at least three stent-delivery elements.

19. The applicator system of claim 17, wherein the distal end of the stent-delivery element remains within the lumen of the sheath throughout the delivery cycle of the applicator.

20. The applicator system of claim 17, wherein the energy source comprises a spring that stores mechanical energy.

21. The applicator system of claim 17, wherein the energy source comprises a solenoid.

22. The applicator system of claim 17, wherein the piercing tip is selected from the group consisting of a knife, a laser probe, a pointed guide member, a radiofrequency energy source, an ultrasonic energy source, a fiber optic laser, and a microwave energy source.

23. The applicator system of claim 17, wherein the piercing member is a pointed guide member.