Devices with dimensions that can be reduced and increased in vivo, and methods of making and using the same
Devices are provided with an internal dimension that can be reduced and increased in vivo. In one example, an interatrial shunt for placement at an atrial septum of a patient's heart includes a body. The body includes first and second regions coupled in fluid communication by a neck region. The body includes a shape-memory material. The body defines a passageway through the neck region for blood to flow between a first atrium and a second atrium. The first and second regions are superelastic at body temperature, and the neck region is malleable at body temperature. A flow area of the passageway through the neck region may be adjusted in vivo.
1. A shunt for implantation within an atrial septum to treat a heart condition, the shunt comprising:
a single, metallic frame comprising a first end region, a second end region, and a middle region disposed therebetween, the first and second end regions each configured to self-expand upon deployment such that the middle region is positioned in an opening in the atrial septum, the single, metallic frame being heat treated such that the middle region is expandable and/or contractible in vivo; and
a biocompatible material coating the first end region, the second end region, and the middle region to define a passageway to permit blood to flow through the atrial septum via the shunt,
wherein a cross-sectional flow area in the passageway is smallest at the middle region, and
wherein the middle region is heat treated to exhibit different shape memory properties than the first and second end regions.
2. The shunt of claim 1 , wherein the middle region comprises a plastically deformable material.
3. The shunt of claim 1 , wherein the middle region is configured to be contracted in vivo via mechanical contraction.
4. The shunt of claim 1 , wherein the middle region is configured to be contracted in vivo via thermal contraction.
5. The shunt of claim 1 , wherein the middle region is configured to expanded in vivo via mechanical expansion.
6. A shunt for implantation within an atrial septum to treat a heart condition, the shunt comprising:
a single, metallic frame comprising a first end region, a second end region, and a middle region disposed therebetween, the first and second end regions each configured to self-expand upon deployment such that the middle region is positioned in an opening in the atrial septum, the single, metallic frame being heat treated such that the middle region is expandable and/or contractible in vivo;
a biocompatible material coating the first end region, the second end region, and the middle region to define a passageway to permit blood to flow through the atrial septum via the shunt; and
one or more sensors configured to measure pressure or blood flow through the passageway or both,
wherein a cross-sectional flow area in the passageway is smallest at the middle region.
7. The shunt of claim 1 , wherein the middle region is expandable in vivo such that a clinical procedure tool may pass through the passageway.
8. The shunt of claim 1 , wherein the middle region is contractible in vivo after removal of a clinical procedure tool from the passageway.
9. The shunt of claim 1 , wherein the middle region is malleable at body temperature and comprises NITINOL having an austenitic finish temperature between 45-60° C.
10. The shunt of claim 9 , wherein the middle region is mechanically expandable and thermally contractible.
11. The shunt of claim 1 , wherein the first end region and the second end region are superelastic and comprise NITINOL having an austenitic finish temperature between 5-20° C.
12. The shunt of claim 1 , wherein the first and second end regions comprise self-expanding superelastic material and the middle region comprises malleable shape-memory material.
13. A shunt for implantation within an atrial septum to treat a heart condition, the shunt comprising:
a single, metallic frame comprising a first end region, a second end region, and a middle region disposed therebetween, the first and second end regions each configured to self-expand upon deployment such that the middle region is positioned in an opening in the atrial septum, the single, metallic frame being heat treated such that the middle region is expandable and/or contractible in vivo; and
a biocompatible material coating the first end region, the second end region, and the middle region to define a passageway to permit blood to flow through the atrial septum via the shunt,
wherein a cross-sectional flow area in the passageway is smallest at the middle region,
wherein the first and second end regions comprise self-expanding superelastic material and the middle region comprises malleable shape-memory material, and
wherein the malleable shape-memory material comprises NITINOL having an austenitic finish temperature (Af) between 45-60° C.
14. The shunt of claim 11 , wherein the self-expanding superelastic material comprises NITINOL having an austenitic finish temperature (Af) between 5-20° C.
15. The shunt of claim 1 , wherein the first and second end regions are superelastic at body temperature and the middle region is malleable at body temperature.
16. The shunt of claim 13 , wherein the middle region is heat treated to exhibit different shape memory properties than the first and second end regions.
17. The shunt of claim 1 , wherein the first and second end regions and the middle region comprise a diabolo-shaped shunt.
18. The shunt of claim 17 , wherein the middle region comprises a cylindrical shunt.
19. The shunt of claim 18 , wherein the cylindrical shunt is outside of the diabolo-shaped shunt.
20. The shunt of claim 1 , wherein an inner diameter of the passageway at the middle region is 4-7 mm.
21. The shunt of claim 1 , wherein the passageway is sized and shaped to permit a sufficient amount of blood to flow through the atrial septum via the shunt to treat pulmonary artery hypertension (PAH).
22. The shunt of claim 1 , wherein the passageway is sized and shaped to permit a sufficient amount of blood to flow through the atrial septum via the shunt to treat heart failure (HF).
23. A method for treating a heart condition, the method comprising:
delivering a shunt to an opening in the atrial septum in a contracted state, the shunt comprising a frame having first and second end regions and a middle region disposed therebetween, the frame heat treated to be adjustable in vivo, the shunt further comprising a biocompatible material coating the first and second end regions and the middle region to define a passageway; and
deploying the shunt within the opening such that the shunt transitions to an expanded state wherein the first end region self-expands and is disposed in a first atrium, the second end region self-expands and is disposed in a second atrium, and the middle region is disposed at the atrial septum to permit blood to flow through the atrial septum via the passageway, wherein a cross-sectional flow area in the passageway is smallest at the middle region and the middle region is adjustable in vivo from a first diameter to a second diameter different than the first diameter,
wherein the middle region is heat treated to exhibit different shape memory properties than the first and second end regions.
24. The method of claim 23 , wherein the first end region, the second end region, and the middle region of the frame are formed from a single metallic frame.
25. The method of claim 23 , wherein the middle region comprises a plastically deformable material.
26. The method of claim 23 , further comprising expanding the middle region in vivo via mechanical expansion.
27. The method of claim 23 , further comprising contracting the middle region in vivo via thermal contraction.
28. The method of claim 23 , further comprising permitting a sufficient amount of blood to flow through the atrial septum via the passageway of the shunt to treat pulmonary artery hypertension (PAH).
29. The method of claim 23 , further comprising permitting a sufficient amount of blood to flow through the atrial septum via the passageway of the shunt to treat heart failure (HF).