Adjustable shunts and associated systems and methods

Patent metadata

Field	Value
Publication number	US-12151071-B2
Application number	US-202017016192-A
Country	US
Kind code	B2
Filing date	Sep 9, 2020
Priority date	Sep 9, 2019
Publication date	Nov 26, 2024
Grant date	Nov 26, 2024

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 frame configured to anchor across a tissue wall dividing a first body region and a second body region of a patient;
a lumen extending through at least a portion of the frame and configured to extend between the first body region of a patient and the second body region of the patient to create an artificial flow path therebetween, wherein the lumen includes an orifice configured to be in fluid communication with the first body region and/or the second body region; and
at least one shape memory actuation element having a first end portion and a second end portion, wherein
the first end portion is coupled to the frame and the second end portion is oriented away from the frame and at least partially defines the lumen orifice,
the at least one shape memory actuation element is transitionable from a first material state to a second material state when heated above a transition temperature that is a temperature greater than body temperature, and
transitioning the at least one shape memory actuation element from the first material state to the second material state adjusts a geometry of the lumen orifice at least partially defined by the second end portion.

2. The adjustable shunt assembly of claim 1 wherein the at least one shape memory actuation element is a first actuation element, the adjustable shunt further comprising a second shape memory actuation element configured to adjust the geometry of the lumen orifice, wherein the second shape memory actuation element is transitionable from the first material state to the second material state when heated above the transition temperature.

3. The adjustable shunt assembly of claim 2 wherein the first shape memory actuation element is configured to increase a cross-sectional area of the lumen orifice when heated above its transition temperature, and wherein the second shape memory actuation element is configured to decrease a cross-sectional area of the lumen orifice when heated above its transition temperature.

4. The adjustable shunt assembly of claim 2 wherein the first shape memory actuation element has a first manufactured geometry and the second shape memory actuation element has a second manufactured geometry different than the first manufactured geometry, and wherein the first shape memory actuation element is coupled to the second shape memory actuation element such that at body temperature the first shape memory actuation element is deformed relative to the first manufactured geometry and the second shape memory actuation element is deformed relative to the second manufactured geometry.

5. The adjustable shunt assembly of claim 4 wherein the first shape memory actuation element is configured to move toward the first manufactured geometry when heated above the transition temperature, and wherein the second shape memory actuation element is configured to move toward the second manufactured geometry when heated above the transition temperature.

6. The adjustable shunt assembly of claim 2 wherein the first shape memory actuation element is thermally insulated from the second shape memory actuation element.

7. The adjustable shunt assembly of claim 2 wherein the first shape memory actuation element and the second shape memory actuation element are configured to be thermally insulated from tissue and blood adjacent the first shape memory actuation element and the second shape memory actuation element when the adjustable shunt assembly is implanted in the patient.

8. The adjustable shunt assembly of claim 7 wherein the first shape memory actuation element is electrically isolated from the second shape memory actuation element.

9. The adjustable shunt assembly of claim 8 wherein the first shape memory actuation element and the second shape memory actuation element are configured to be electrically isolated from tissue and blood adjacent the first and second shape memory actuation elements when the adjustable shunt assembly is implanted in the patient.

10. The adjustable shunt assembly of claim 1 , further comprising a membrane, wherein the membrane at least partially defines the lumen.

11. The adjustable shunt assembly of claim 10 wherein the at least one shape memory actuation element is coupled to the membrane and has a stent-like structure.

12. The adjustable shunt assembly of claim 10 wherein the membrane includes a first membrane portion coupled to the frame and a second membrane portion coupled to the shape memory actuator and configured to extend into the first body region or the second body region.

13. The adjustable shunt assembly of claim 12 wherein the at least one shape memory actuation element is disposed within the second membrane portion.

14. The adjustable shunt assembly of claim 1 wherein the at least one shape memory actuation element is disposed radially around the orifice.

15. The adjustable shunt assembly of claim 1 wherein the at least one shape memory actuation element is composed of a shape memory alloy, and wherein the first material state is a martensitic or R-phase material state, and wherein the second material state is an R-phase or austenitic material state.

16. The adjustable shunt assembly of claim 1 wherein the frame is composed of superelastic Nitinol.

17. The adjustable shunt assembly of claim 1 wherein the transition temperature is a temperature greater than 40 degrees Celsius.

18. The adjustable shunt assembly of claim 1 wherein the first body region is a left atrium of a heart and the second body region is a right atrium of the heart.

19. An adjustable shunt assembly, comprising:
a self-expanding frame configured to anchor across a tissue wall dividing a first body region and a second body region of a patient;
a membrane coupled to the frame, wherein the membrane at least partially defines a lumen configured to extend between the first body region and the second body region to create an artificial flow path therebetween; and
at least one shape memory actuation element having a frustoconical shape with a first end portion coupled to the frame and a second end portion spaced apart from the frame, wherein the at least one shape memory actuation element is transitionable from a first material state to a second material state when heated above a transition temperature that is a temperature greater than body temperature, and wherein transitioning the at least one shape memory actuation element from the first material state to the second material state modifies the geometry of the lumen.

20. The adjustable shunt assembly of claim 19 wherein the at least one shape memory actuation element is a first actuation element, the adjustable shunt further comprising a second shape memory actuation element configured to adjust the geometry of the lumen, and wherein the second shape memory actuation element is transitionable from the first material state to the second material state when heated above the transition temperature greater than body temperature.

21. The adjustable shunt assembly of claim 20 wherein the first shape memory actuation element is configured to increase a cross-sectional area of the lumen when heated above its transition temperature, and wherein the second shape memory actuation element is configured to decrease a cross-sectional area of the lumen when heated above its transition temperature.

22. The adjustable shunt assembly of claim 20 wherein the first shape memory actuation element is configured to increase

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