Adjustable flow glaucoma shunts and associated systems and methods

Patent metadata

Field	Value
Publication number	US-12453657-B2
Application number	US-202217979631-A
Country	US
Kind code	B2
Filing date	Nov 2, 2022
Priority date	Oct 10, 2019
Publication date	Oct 28, 2025
Grant date	Oct 28, 2025

Abstract

The present technology is directed to adjustable flow glaucoma shunts and methods for making and using such devices. In many of the embodiments described herein, the shunts include a generally flat frame. The frame can include an elongated portion having a lumen extending therethrough and a bladder portion defining an interior chamber that is in fluid communication with the lumen. When implanted in a patient's eye, aqueous can drain from the anterior chamber to a target outflow location via the lumen and interior chamber. In some embodiments, the shunts include a flow control assembly positioned within the interior chamber of the bladder portion to control the flow of aqueous through the lumen.

First claim

We claim:

1. A method of manufacturing a flow control assembly for use with an implantable medical device, the method comprising: fabricating a unitary structure corresponding to the flow control assembly, wherein the unitary structure includes a first actuation element, a second actuation element, a gating element, a first portion having an unrestrained end portion, and a second portion; and coupling the unrestrained end portion of the first portion to the second portion to form the flow control assembly, wherein: coupling the unrestrained end portion to the second portion induces strain in first actuation element and the second actuation element, and after the unrestrained end portion has been coupled to the second portion, (a) the first actuation element is configured to selectively move the gating element in a first direction in response to a reduction in the strain induced in the first actuation element, and (b) the second actuation element is configured to selectively move the gating element in a second direction, different than the first direction, in response to a reduction in the strain induced in the second actuation element.

2. The method of claim 1 wherein coupling the unrestrained end portion to the second portion mechanically deforms the first actuation element and the second actuation element to induce the strain therein.

3. The method of claim 2 wherein coupling the unrestrained end portion to the second portion compresses the first actuation element and the second actuation element to induce the strain therein.

4. The method of claim 2 wherein coupling the unrestrained end portion to the second portion comprises stretching the first actuation element and the second actuation element to induce the strain therein.

5. The method of claim 1 wherein the unitary structure is composed of a shape memory material.

6. The method of claim 1 wherein the unitary structure is composed of Nitinol.

7. The method of claim 1 wherein the second portion of the flow control assembly includes an anchor portion.

8. A method of manufacturing a flow control assembly from a unitary structure for use with an implantable medical device, wherein the unitary structure has an actuation element, a gating element, a first portion with an unrestrained end portion, and a second portion, and wherein the method comprises: coupling the unrestrained end portion of the first portion to the second portion to form the flow control assembly, wherein coupling the unrestrained end portion to the second portion induces strain in the actuation elements and, wherein once the flow control assembly is formed, the actuation element is configured to selectively move the gating element in a first direction in response to a reduction in the strain induced in the actuation element.

9. The method of claim 8 wherein coupling the unrestrained end portion to the second portion changes a shape of the actuation elements to induce the strain therein.

10. The method of claim 9 wherein coupling the unrestrained end portion to the second portion compresses the actuation elements to induce the strain therein.

11. The method of claim 9 wherein coupling the unrestrained end portion to the second portion comprises stretching the actuation elements to induce the strain therein.

12. The method of claim 8 wherein the flow control assembly is configured to be coupled to an implantable shunt such that the flow control assembly is operable to selectively control the flow of fluid through the shunt after the shunt has been implanted in a patient.

13. The method of claim 8 wherein the actuation element is a first actuation, and wherein the unitary structure further includes a second actuation element, and wherein, once the flow control assembly is formed, the second actuation element is configured to selectively move the gating element in a second direction, different than the first direction, in response to a reduction in the strain induced in the second actuation element.

14. A method of manufacturing an actuation assembly for use with an implantable medical device, the method comprising: receiving a unitary structure corresponding to the actuation assembly, wherein the unitary structure includes an actuation element, a gating element, a first portion having an unrestrained end portion, and a second portion, and wherein the actuation element has a first geometry; and coupling the unrestrained end portion of the first portion to the second portion to form the actuation assembly, wherein coupling the unrestrained end portion to the second portion deforms the actuation element such that it has a second geometry different than the first geometry, and wherein once the actuation assembly is formed, the actuation element is configured to selectively move the gating element in a first direction in response to the actuation element transitioning from the second geometry back towards the first geometry.

15. The method of claim 14 wherein the first geometry has a greater length than the second geometry.

16. The method of claim 14 wherein the first geometry has a shorter length than the second geometry.

17. The method of claim 14 wherein the unitary structure is composed of a shape memory material.

18. The method of claim 14 wherein: the actuation element is a first actuation element, the actuation assembly further includes a second actuation element, and coupling the unrestrained end portion of the first portion to the second portion deforms both the first actuation element and the second actuation element.

Assignees

• Shifamed Holdings Llc

Inventors

• Lilly Richard
• Argento Claudio
• Sapozhnikov Katherine
• Engelman Christopher J
• Orth Jean

Classifications

• A61F2250/0013

  for adjusting fluid pressure · CPC title

• A61F2240/001

  Designing or manufacturing processes · CPC title

• A61F2210/0014

  using shape memory or superelastic materials, e.g. nitinol · CPC title

• A61F9/00781 Primary

  Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment (drainage implants in general A61M27/002) · CPC title

• A61L27/06

  Titanium or titanium alloys · CPC title