Adjustable intraocular flow regulation

• US 10,195,078 B2
• Filed: 05/16/2016
• Issued: 02/05/2019
• Est. Priority Date: 02/19/2013
• Status: Active Grant

• Current Assignee: AqueSys, Inc. (Abbvie Incorporated)
• Original Assignee: AqueSys, Inc. (Abbvie Incorporated)
• Inventors: Horvath, Christopher, Romoda, Laszlo O., Hamstrom, Brian, Bache, Ronald D., Grabner, Guenther, Reitsamer, Herbert A.
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): Weng, Kai
• Application Number:
  US15/156,168
• Publication Number:
  US 20160256321A1
• Time in Patent Office: 995 Days
• CPC Class Codes: A61F 2009/00891 Glaucoma
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/007 Methods or devices for eye surgery
• CPC Class Codes: A61F 9/00736 Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments A61F9/008 takes precedence
• 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: A61L 31/08 Materials for coatings
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2210/0612 Eyes
• 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

Methods and devices for adjusting or configuring the flow rate of an intraocular shunt are provided whereby hypotony can be avoided by increasing the flow rate through the device. In some embodiments, the device is a shunt that can have a first flow that can be modified to a second flow by modifying the shunt, such as by cutting the shunt. Additionally, one or more dissolvable portions can be present to provide an initial flow restriction and subsequent increase in flow over time.

Claims

1. A method of deploying into an eye an intraocular shunt having a variable flow rate, the method comprising:

inserting into the eye a hollow shaft configured to hold the shunt;

deploying the shunt from the hollow shaft such that the shunt extends from an anterior chamber of the eye to a location of lower pressure of the eye, the shunt having a first restrictive dissolvable section at a first end thereof and a second, permanent restrictive section at a second end thereof, the dissolvable section comprising a pharmaceutical or biological agent deliverable to the eye, the shunt having a first nonzero flow rate therethrough, the second, permanent restrictive section being severable to adjust a flow of fluid through the shunt; and

withdrawing the hollow shaft from the eye.

2. The method of claim 1, wherein deploying the shunt comprises positioning the dissolvable section in the location of lower pressure.

3. The method of claim 1, wherein the dissolvable section comprises a dissolution rate that is different than a dissolution rate of the main section.

4. The method of claim 1, wherein the dissolvable section comprises first and second dissolvable portions.

5. The method of claim 4, wherein the first and second dissolvable portions have different dissolution rates.

6. The method of claim 4, wherein the first and second dissolvable portions each comprise the pharmaceutical or biological agent.

7. The method of claim 1, wherein the pharmaceutical or biological agent comprises a coating on an interior surface of the shunt.

8. The method of claim 1, wherein the dissolvable section is impregnated with the pharmaceutical or biological agent.

9. The method of claim 1, wherein the pharmaceutical or biological agent comprises a time-release pharmaceutical or biological agent.

10. The method of claim 1, wherein the location of lower pressure is selected from the group consisting of:

intra-Tenon'"'"'s space, the subconjunctival space, the episcleral vein, the suprachoroidal space, and Schlemm'"'"'s canal.

11. The method of claim 1, further comprising separating at least a portion of the second, permanent restrictive section from the shunt.

12. The method of claim 1, further comprising separating at least a portion of the second, permanent restrictive section from the shunt after withdrawing the hollow shaft from the eye.

13. A method of deploying into an eye an intraocular shunt having a variable flow rate, the method comprising:

inserting into the eye a hollow shaft configured to hold the shunt;

deploying the shunt from the hollow shaft such that the shunt extends from an anterior chamber of the eye to a location of lower pressure of the eye, the shunt having a first restrictive dissolvable section at a first end thereof and a second, permanent restrictive section at a second end thereof, the dissolvable section having a lumen to conduct fluid therethrough, the shunt having a first nonzero flow rate therethrough, the second, permanent restrictive section being severable to adjust a flow of fluid through the shunt; and

withdrawing the hollow shaft from the eye.

14. The method of claim 13, wherein deploying the shunt comprises positioning the dissolvable section in the location of lower pressure.

15. The method of claim 13, wherein the dissolvable section comprises a dissolution rate that is different than a dissolution rate of the main section.

16. The method of claim 13, wherein the dissolvable section comprises first and second dissolvable portions.

17. The method of claim 16, wherein the first and second dissolvable portions have different dissolution rates.

18. The method of claim 16, wherein the first and second dissolvable portions are concentrically layered within a lumen of the shunt.

19. The method of claim 13, further comprising:

determining the position of the shunt in the eye extending between (i) the anterior chamber of the eye and (ii) the location of lower pressure of the eye; and

separating a shunt fragment of the dissolvable section from the shunt such that the shunt has a second flow rate higher than the first flow rate.

20. The method of claim 13, further comprising a pharmaceutical or biological agent.

21. The method of claim 20, wherein the pharmaceutical or biological agent comprises a coating on an interior surface of the shunt.

22. The method of claim 20, wherein the dissolvable section is impregnated with the pharmaceutical or biological agent.

23. The method of claim 20, wherein the pharmaceutical or biological agent comprises a time-release pharmaceutical or biological agent.

24. The method of claim 13, wherein the location of lower pressure is selected from the group consisting of:

intra-Tenon'"'"'s space, the subconjunctival space, the episcleral vein, the suprachoroidal space, and Schlemm'"'"'s canal.