Adjustable flow glaucoma shunts and associated systems and methods

Patent metadata

Field	Value
Publication number	US-12472097-B2
Application number	US-202217979664-A
Country	US
Kind code	B2
Filing date	Nov 2, 2022
Priority date	Jan 23, 2020
Publication date	Nov 18, 2025
Grant date	Nov 18, 2025

Abstract

The present technology is directed to adjustable shunts for treating glaucoma. In particular, some embodiments provide shunts having a plurality of individually actuatable flow control elements that can control the flow of fluid through associated ports and/or flow lumens. For example, each individually actuatable flow control element can be actuated to block and/or unblock a corresponding port and/or flow lumen. Accordingly, the shunts described herein can be manipulated into a variety of configurations that provide different drainage rates based on whether the ports and/or flow lumens are blocked or unblocked, therefore providing a titratable glaucoma therapy for draining aqueous from the anterior chamber of the eye.

First claim

We claim:

1 . An adjustable shunt, comprising:
a drainage element having a first end region positionable within a first body region of a patient and a second end region positionable within a second body region of the patient, wherein the drainage element further includes a first fluid flow path having a first port and a first channel, and a second fluid flow path having a second port and a second channel; and a flow control mechanism for controlling the flow of fluid through the drainage element, the flow control mechanism including—
a first actuator having a first gating element moveable between a first position providing a first fluid resistance at the first port of the first fluid flow path and a second position providing a second fluid resistance at the first port of the first fluid flow path that is different than the first fluid resistance while maintaining a constant dimension of the first channel, and
a second actuator having a second gating element moveable between a third position providing a third fluid resistance at the second port of the second fluid flow path and a fourth position providing a fourth fluid resistance at the second port of the second fluid flow path that is different than the third fluid resistance while maintaining a constant dimension of the second channel,
wherein the first gating element and the second gating element are independently and repeatably moveable between their respective positions.

2 . The adjustable shunt of claim 1 wherein:
the first gating element is configured to slidably interfere with the first port in at least one of the first and second positions, and
the second gating element is configured to slidably interfere with the second port in at least one of the third and fourth positions.

3 . The adjustable shunt of claim 1 wherein the first channel is sized and/or shaped to provide a different resistance than the second channel.

4 . The adjustable shunt of claim 3 wherein a ratio of the resistance provided by the first channel to the resistance provided by the second channel is about 1:2.

5 . The adjustable shunt of claim 1 wherein the first fluid flow path and the second fluid flow path are arranged in parallel.

6 . The adjustable shunt of claim 1 wherein the first fluid flow path and the second fluid flow path are arranged in series.

7 . The adjustable shunt of claim 1 wherein:
the first actuator further includes a first shape memory actuation element and a second shape memory actuation element, wherein (a) the first shape memory actuation element is configured to move the first gating element toward the first position in response to being actuated, and (b) the second shape memory actuation element is configured to move the first gating element toward the second position in response to being actuated, and
the second actuator further includes a third shape memory actuation element and a fourth shape memory actuation element, wherein (c) the third shape memory actuation element is configured to move the second gating element toward the third position in response to being actuated, and (d) the fourth shape memory actuation element is configured to move the second gating element toward the fourth position in response to being actuated.

8 . The adjustable shunt of claim 1 wherein the first actuator and the second actuator are composed at least in part of Nitinol.

9 . An adjustable shunt, comprising:
a drainage element having a first end region positionable within a first body region of a patient and a second end region positionable within a second body region of the patient, the drainage element including a first fluid flow path extending at least partially therethrough and a second fluid flow path extending at least partially therethrough, wherein the first flow path includes a first port and a first channel and the second flow path includes a second port and a second channel; a first actuator positioned to selectively control a fluid resistance along at least a first portion of the first fluid flow path, the first actuator having a first gating element slidably moveable to at least partially interface with the first port to selectively control the fluid resistance along the first portion of the first fluid flow path; and a second actuator positioned to selectively control a fluid resistance along at least a second portion of the second fluid flow path, the second actuator having a second gating element slidably moveable to at least partially interface with the first port to selectively control the fluid resistance along the second portion of the second fluid flow path, wherein the first actuator and the second actuator are independently and repeatedly actuatable to selectively control the fluid resistance along the first portion of the first fluid flow path and the second portion of the second fluid flow path, respectively.

10 . The adjustable shunt of claim 9 wherein the first channel has a first fluid resistance, and wherein the second channel has a second fluid resistance.

11 . The adjustable shunt of claim 10 wherein the first fluid resistance and the second fluid resistance are different.

12 . The adjustable shunt of claim 11 wherein a ratio between the first fluid resistance and the second fluid resistance is about 1:2.

13 . The adjustable shunt of claim 10 wherein the first fluid resistance and the second fluid resistance are the same or at least about the same.

14 . The adjustable shunt of claim 9 wherein the first fluid flow path and the second fluid flow path are arranged in parallel.

15 . The adjustable shunt of claim 9 wherein the first fluid flow path and the second fluid flow path are arranged in series.

16 . A method of adjusting a shunt implanted in a patient, the shunt having at least a first fluid flow path having a first channel, a first actuator having a first gating element for selectively changing a first fluid resistance along at least a first portion of the first fluid flow path, a second fluid flow path having a second channel, and a second actuator having a second gating element for selectively changing a second fluid resistance along at least a second portion of the second fluid flow path, the method comprising:
actuating (a) the first actuator to move the first gating element to change the first fluid resistance along the first portion of the first fluid flow path while maintaining a constant dimension of the first channel, (b) the second actuator to move the second gating element to change the second fluid resistance along the second portion of the second fluid flow path while maintaining a constant dimension of the second channel, or (c) both (a) and (b), wherein the first actuator and the second actuator are independently actuatable such that actuating the first actuator changes the first fluid resistance without changing the second fluid resistance, and actuating the second actuator changes the second fluid resistance without changing the first fluid resistance.

17 . The method of claim 16 wherein the first actuator and the second actuator are composed at least in part of a shape memory material.

18 . The method of claim 17 wherein actuating the first actuator and/or the second actuator includes heating a portion of the first actuator and/or a portion of the second actuator.

19 . The method of claim 17 wherein actuating the first actuator and/or the second actuator includes directing laser energy from an energy source external to the patient at the first actuator and/or the second actuator.

Assignees

• Shifamed Holdings Llc

Inventors

• Chang Robert
• Sapozhnikov Katherine
• Argento Claudio
• Saul Tom
• Lilly Richard

Classifications

• A61F2250/0004

  adjustable · CPC title

• A61F9/00781 Primary

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