Adjustable shunts and associated systems and methods

Patent metadata

Field	Value
Publication number	US-12343487-B2
Application number	US-202117506565-A
Country	US
Kind code	B2
Filing date	Oct 20, 2021
Priority date	Sep 9, 2019
Publication date	Jul 1, 2025
Grant date	Jul 1, 2025

Abstract

The present technology is directed to adjustable interatrial shunting systems that selectively control blood flow between the left atrium and the right atrium of a patient. The adjustable interatrial devices include a shunting element having an outer surface configured to engage native tissue and an inner surface defining a lumen that enables blood to flow from the left atrium to the right atrium when the system is deployed across the septal wall. The systems can include an actuation assembly for selectively adjusting a geometry of the lumen and/or a geometry of a lumen orifice to control the flow of blood through the lumen.

First claim

We claim:

1. An adjustable shunt assembly, comprising:
a self-expanding shunting element configured to extend through a tissue wall between a first body region of a patient and a second body region of the patient, wherein the shunting element comprises an artificial lumen through the tissue wall to shunt fluid between the first body region and the second body region of the patient; and
a shape memory actuation element coupled to the shunting element and configured to adjust a geometry of the artificial lumen, wherein the shape memory actuation element is mechanically adjustable at body temperature and thermally adjustable when heated above a transition temperature greater than the body temperature,
wherein the shunt assembly is configured such that mechanically adjusting the shape memory actuation element induces a first change in a dimension of the artificial lumen and thermally adjusting the shape memory actuation element induces a second change in the dimension of the artificial lumen.

2. The adjustable shunt assembly of claim 1 wherein the first change includes either an increase or a decrease in the dimension, and wherein the second change includes the other of either the increase or the decrease in the dimension, such that the first change and the second change are different.

3. The adjustable shunt assembly of claim 1 wherein the transition temperature is at least about 45 degrees Celsius.

4. The adjustable shunt assembly of claim 1 wherein, at body temperature, the shape memory actuation element is configured to be mechanically adjusted by an inflatable balloon.

5. The adjustable shunt assembly of claim 1 wherein the shape memory actuation element is configured to be heated above the transition temperature using an energy source delivered via a catheter.

6. The adjustable shunt assembly of claim 1 wherein the shape memory actuation element is configured to be resistively heated above the transition temperature.

7. The adjustable shunt assembly of claim 1 wherein the shape memory actuation element is composed, at least in part, of nitinol and/or a nitinol-based alloy.

8. The adjustable shunt assembly of claim 1 wherein the shape memory actuation element is in a martensitic material state or an R-phase material state at body temperature, and wherein the shape memory actuation element is configured to transition to an R-phase material state or an austenitic material state when heated above the transition temperature.

9. The adjustable shunt assembly of claim 1 wherein the artificial lumen is at least partially defined by the shape memory actuation element.

10. The adjustable shunt assembly of claim 1 wherein the artificial lumen includes an orifice, and wherein changing a dimension of the artificial lumen includes changing a diameter of the orifice.

11. The adjustable shunt assembly of claim 1 wherein the tissue wall is a septal wall, the first body region is a left atrium of the patient's heart, the second body region is a right atrium of the patient's heart, and the adjustable shunt assembly is configured to shunt blood from the left atrium to the right atrium.

12. An adjustable shunt assembly, comprising:
a self-expanding shunting element having an artificial lumen extending therethrough and configured to extend through a septal wall between a left atrium of a patient and a right atrium of the patient to shunt fluid therebetween; and
a shape memory actuation element carried by the shunting element, wherein the shape memory actuation element is transitionable between a first material state and a second material state by heating the shape memory actuation element above a transition temperature greater than body temperature, and wherein—
in the first material state, the shape memory actuation element is configured to be mechanically deformed relative to its manufactured geometry to alter a dimension of the lumen; and
the shape memory actuation element is configured such that heating the shape memory actuation element above the transition temperature causes the shape memory actuation element to transition to the second material state and, if the shape memory actuation element is deformed relative to the manufactured geometry, move to and/or toward the manufactured geometry.

13. The adjustable shunt assembly of claim 12 wherein the transition temperature is at least about 45 degrees Celsius.

14. The adjustable shunt assembly of claim 12 wherein the shape memory actuation element comprises nitinol and/or nitinol alloys.

15. The adjustable shunt assembly of claim 12 wherein the first material state is a martensitic material state or an R-phase material state, and wherein the second material state is an R-phase material state or an austenitic material state.

16. The adjustable shunt assembly of claim 12 wherein the shape memory actuation element at least partially defines the lumen.

17. A method of adjusting flow through a shunting assembly implanted in a septal wall of a heart of a patient, the shunting assembly having a shape memory actuation element and defining an artificial lumen through the septal wall fluidly connecting a left atrium of the patient and a right atrium of the patient, the method comprising:
inducing a first change in a cross-sectional dimension of the lumen by heating the shape memory actuation element above a transition temperature to cause the shape memory actuation element to transition from a first material state to a second material state, wherein transitioning from the first material state to the second material state induces a geometric change in the shape memory actuation element and induces the first change in the cross-sectional dimension of the lumen; and
inducing a second change in the cross-sectional dimension of the lumen by mechanically deforming the shape memory actuation element.

18. The method of claim 17 wherein inducing the first change includes adjusting the cross-sectional dimension in a first direction, and wherein inducing the second change includes adjusting the cross-sectional dimension in a second direction that is generally opposite the first direction.

19. The method of claim 17 wherein inducing the first change occurs before inducing the second change.

20. The method of claim 17 wherein inducing the second change occurs before inducing the first change.

21. The method of claim 17 wherein the transition temperature is greater than body temperature.

22. The method of claim 17 wherein the transition temperature is at least about 45 degrees Celsius.

23. The method of claim 17 wherein the first material state is a martensitic material state or an R-phase material state, and wherein the second material state is an R-phase material state or an austenitic material state.

Assignees

• Shifamed Holdings Llc

Inventors

• Fahey Brian
• Robertson Scott
• Gould William L
• Fox William Jason
• Argento Claudio
• Pantages Anthony
• Alexander Miles
• Andriola Peter

Classifications

• A61M2205/0266

  Shape memory materials · CPC title

• A61M2205/3653

  by Joule effect, i.e. electric resistance · CPC title

• A61M2210/125

  Heart · CPC title

• A61M39/22

  Valves or arrangement of valves {(A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405)} · CPC title

• A61B2017/00929

  isolating electrical current · CPC title