Adjustable flow glaucoma shunts and methods for making and using same

Patent metadata

Field	Value
Publication number	US-12329682-B2
Application number	US-202017422613-A
Country	US
Kind code	B2
Filing date	Jan 17, 2020
Priority date	Jan 18, 2019
Publication date	Jun 17, 2025
Grant date	Jun 17, 2025

Abstract

Adjustable flow glaucoma shunts are disclosed herein. In one embodiment, for example, a variable flow shunt for treatment of glaucoma in a human patient includes an elongated outflow tube having (a) a proximal inflow portion configured for placement within an anterior chamber in a region outside of an optical field of view of an eye of the patient, and (b) a distal outflow portion at a different location of the eye. The variable flow shunt further includes a flow control mechanism positioned along the outflow tube between the inflow portion and the outflow portion. The flow control mechanism comprises one or more control elements transformable between an open position that allows fluid to flow through the outflow tube and resistance positions that partially obstruct or attenuate fluid flow through the outflow tube. During operation, the control element(s) are movable between positions in response to non-invasive energy.

First claim

We claim:

1. A variable flow shunt for treatment of glaucoma in a human patient, the variable flow shunt comprising:
an elongated outflow tube having (a) a proximal inflow portion configured for placement within an anterior chamber in a region outside of an optical field of view of an eye of the patient, and (b) a distal outflow portion at a different location of the eye; and
a flow control mechanism positioned along the outflow tube between the inflow portion and the outflow portion, wherein the flow control mechanism comprises two actuation elements in contact with and partially overlapping each other, wherein the two actuation elements are selectively actuatable to pivotably move the flow control mechanism between an open position that allows fluid to flow through the outflow tube and at least one resistance position that reduces fluid flow through the outflow tube, and wherein the actuation elements include—
a first actuation element selectively actuatable to move the flow control mechanism from the open position to the at least one resistance position, and
a second actuation element selectively actuatable to move the flow control mechanism from the resistance position back toward the open position, and

wherein, during operation, the flow control mechanism is pivotably movable between the open position and the at least one resistance position in response to non-invasive laser energy.

2. The variable flow shunt of claim 1 wherein the flow control mechanism is pivotably movable between a first resistance position that provides a first level of reduction of fluid flow, and a second resistance position that provides a second level of reduction of fluid flow greater than the first level of reduction.

3. The variable flow shunt of claim 1 wherein the flow control mechanism is pivotably movable between a first resistance position that provides a first level of flow reduction and a plurality of second resistance positions that provide increasing levels of flow reduction.

4. The variable flow shunt of claim 1 wherein the flow control mechanism is configured to partially obstruct fluid flow through the outflow tube in the at least one resistance position by changing a cross-sectional shape of a flow path through the outflow tube.

5. The variable flow shunt of claim 1 wherein the actuation elements are configured to hold the flow control mechanism in the open position or the at least one resistance position without power.

6. The variable flow shunt of claim 1 wherein:
the first actuation element comprises a first finger pivotably movable between a first, open position in which the first finger is out of a flow path through the outflow tube and one or more second resistance positions in which the first finger impedes fluid flow along the flow path; and
the second actuation element comprises a second finger c, wherein the second finger is engaged with the first finger and configured to pivotably move the first finger from the one or more one or more second resistance positions toward the first open position,
wherein the first and second fingers are pivotably movable in response to the non-invasive laser energy.

7. A shunt for treatment of glaucoma in a human patient, the shunt comprising:
an elongated outflow drainage tube having an inflow region and an outflow region; and
a transition region along the outflow tube between the inflow region and the outflow region, wherein the transition region comprises a first actuation element and a second actuation element in contact with and partially overlapping the first actuation element, and
wherein, during operation—
the first actuation element of the transition region is actuatable to change the transition region from a first cross-sectional shape to a second cross-sectional shape different than the first cross-sectional shape to inhibit and/or attenuate fluid flow through the outflow tube, and
the second actuation element of the transition region is actuatable to change the transition region from the second cross-sectional shape back toward the first cross-sectional shape to increase fluid flow through the outflow tube, and

wherein the transition region is configured to transform between the first cross-sectional shape and the second cross-sectional shape upon application of non-invasive laser energy to one or more selected areas of the transition region.

8. A method for treating glaucoma in a human patient, the method comprising:
positioning a variable flow shunt within an eye of the patient, wherein the shunt comprises—
an elongated outflow drainage tube having a proximal inflow region at a first portion of the eye and a distal outflow region at a second, different portion of the eye; and
a flow control assembly carried by the elongated outflow drainage tube, wherein the flow control assembly includes a first actuation element and a second actuation element in contact with and partially overlapping each other,
wherein the first actuation element is selectively actuatable to move the flow control assembly from a first configuration in which flow of aqueous along a flow path of the drainage tube is not impeded to a second, different configuration in which the flow of aqueous is attenuated, and
wherein the second actuation element is selectively actuatable to move the flow control mechanism from the second configuration back toward the first configuration; and

transforming the flow control assembly carried by the elongated outflow drainage tube, via laser energy from an energy source external to the patient, to pivotably move the first actuation element of the flow control assembly from the first configuration to the second configuration to selectively reduce the flow of aqueous along the flow path.

9. The method of claim 8 , further comprising transforming the flow control assembly, via the laser energy, to pivotably move the second actuation element of the flow control assembly from the second configuration back toward the first configuration such that the first and second actuation elements are moved out of the flow path of the drainage tube and flow along the flow path is returned to a non-attenuated state.

10. The variable flow shunt of claim 1 wherein the actuation elements are composed of a shape memory material.

11. The shunt of claim 7 wherein the transition region is composed, at least in part, of a shape memory material.

12. The method of claim 8 , further comprising pivotably moving the first actuation element, via the laser energy, to a plurality of additional second configurations that provide increasing levels of flow attenuation along the flow path through the drainage tube.

13. The method of claim 8 wherein transforming the flow control assembly from the first configuration to the second configuration comprises changing a cross-sectional shape of the flow path through the drainage tube.

14. The method of claim 8 wherein the first and second actuation elements are composed, at least in part, of a shape memory material.

15. The variable flow shunt of claim 1 wherein the two actuation elements are positioned to move together during operation.

Assignees

• Shifamed Holdings Llc

Inventors

• Argento Claudio
• Mixter Colin
• Backus Andrew

Classifications

• A61F9/0017

  implantable in, or in contact with, the eye, e.g. ocular inserts · CPC title

• A61M2210/0612

  Eyes · CPC title

• F16K2099/0088

  Implanted devices · CPC title

• A61M2205/3341

  stabilising pressure or flow to avoid excessive variation · CPC title

• A61F2250/0097

  Visible markings, e.g. indicia · CPC title