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EP-4168096-B1 - RECONFIGURABLE FLUID DISPLACEMENT APPARATUSES AND METHODS OF USE

EP4168096B1EP 4168096 B1EP4168096 B1EP 4168096B1EP-4168096-B1

Inventors

  • NAJMABADI, KAMRAN
  • BEYGUI, Ramin
  • SHAMIMI, Ali

Dates

Publication Date
20260506
Application Date
20210617

Claims (15)

  1. A ventricular assist device (1000) configured to be placed in a ventricle of a heart, the ventricular assist device (1000) comprising: a pumping pouch (1100) having an opening (1110) and defining an internal volume (1100v) configured to fill with blood in through the opening (1110); a contraction element (1200) coupled to the pumping pouch (1100), the contraction element (1200) being actuatable upon receipt of an actuation signal between first and second states in which force is exerted or not exerted inward on the pumping pouch (1100) such that when force is exerted inward on the pumping pouch (1100), at least a portion of the pumping pouch (1100) is squeezed to force at least a portion of the blood out through the opening (1110); a frame (1300) including an upper ring (1310) coupled to the pumping pouch (1100) along an edge of the opening (1110), the frame (1300) configured to be coupled to a wall of the heart; and a controller (1500) electrically coupled to the contraction element (1200), the controller (1500) comprising a processor (1510) configured to receive, in use, a signal from a sensor (1520) configured to sense beating of the heart and to provide the actuation signal to the contraction element (1200) to synchronize actuation of the contraction element (1200) between the first and second states with the beating of the heart.
  2. The ventricular assist device of claim 1, wherein the contraction element includes an electroactive polymer
  3. The ventricular assist device of claim 1, wherein the contraction element includes one or more of: a shape memory alloy; shape memory ceramic; and a twisted coil alloy.
  4. The ventricular assist device of claim 1, wherein the contraction element is actuated by electricity.
  5. The ventricular assist device of claim 1, wherein the contraction element includes a circumferential band coupled to a side wall of the pumping pouch, the circumferential band encircling the internal volume.
  6. The ventricular assist device of claim 1, wherein the contraction element includes a helix coupled to a side wall of the pumping pouch, the helix winding around the internal volume.
  7. The ventricular assist device of claim 1, wherein the contraction element includes a partial band coupled to a side wall of the pumping pouch, the partial band at least partially encircling the internal volume.
  8. The ventricular assist device of claim 1, wherein the contraction element includes a flap coupled to a side wall of the pumping pouch, the flap having a first end portion coupled to the pumping pouch, the flap having a second end portion that is free.
  9. The ventricular assist device of claim 1, wherein the contraction element includes a side strip coupled to a side wall of the pumping pouch, the side strip extending from an upper portion of the pumping pouch to a lower portion of the pumping pouch or wherein the contraction element includes a bottom strip coupled to a bottom wall of the pumping pouch.
  10. The ventricular assist device of claim 1, wherein the contraction element includes a spring coupled to a bottom wall of the pumping pouch.
  11. The ventricular assist device of claim 1, wherein the frame includes an upper ring coupled to an upper portion of the pumping pouch, a lower ring coupled to a lower portion of the pumping pouch, and one or more struts coupling the upper ring to the lower ring.
  12. The ventricular assist device of claim 1, wherein the frame includes one or more tissue anchors configured to be coupled to the wall of the heart.
  13. The ventricular assist device of claim 1, wherein the pumping pouch is impermeable to blood.
  14. The ventricular assist device of claim 1, wherein the pumping pouch is made of an inelastic material.
  15. The ventricular assist device of claim 1, further comprising: a stem coupled to the pumping pouch, the stem configured to be coupled to the wall of the heart.

Description

CROSS-REFERENCE TO RELATED APPLICATION This application claims the benefit of U.S. provisional patent application serial no. 63/040,430, filed June 17, 2020. BACKGROUND Heart failure occurs when the heart cannot pump enough blood for the needs of the body. Heart failure may be caused by a variety of conditions, including coronary artery disease, previous heart attacks, high blood pressure, damaged heart valves, and damaged heart muscle. Ventricular assist devices may be used to supplement heart function. Some ventricular assist devices deliver continuous flow, which may introduce undesirable effects as the blood flow deviates from a normal, pulsatile flow. Other ventricular assist devices use pumps with high-speed rotating elements, which may damage red blood cells. What is needed is a ventricular assist device that provides pulsatile flow. What is needed is a ventricular assist device that reduces damage to red blood cells. US 2014/179993 discloses a foldable and expandable frame having at least one anchoring formation attached to an elongate manipulator and placed in a catheter tube while folded. The tube is inserted into a left ventricle of a heart where the frame is ejected from the tube and expands in the left ventricle. Movements of the elongate manipulator cause the anchor to penetrate the heart muscle and the elongate manipulator to release the frame. The installed frame minimizes the effects of an akinetic portion of the heart forming an aneurysmic bulge. WO 2108/068341 discloses an intraventricular pulsatile blood pump that can be fixedly arranged at the cardiac apex inside a ventricle so as to generate an open-type pulsatile effect. The pulsatile blood pump is generally of a jellyfish shape, comprising a bell-shaped body and a driving source, with an opening of the bell-shaped body being opposite to an outlet of the ventricle, the driving source driving the bell-shaped body to perform systolic or diastolic movements. The systolic or diastolic movements of the bell-shaped body drive the blood inside the ventricle to be ejected directionally to an artery and to form a swirl type blood flow field between an inner wall of the bell-shaped body and an inner wall of the ventricle. SUMMARY The invention is defined in the independent claim, with optional features being defined in the dependent claims. Ventricular assist devices configured to be placed in a ventricle of a heart are described. In one embodiment, a ventricular assist device comprises a pumping pouch having an opening and defining an internal volume configured to fill with blood in through the opening. The ventricular assist device further comprises a contraction element coupled to the contraction pouch and actuatable upon receipt of an actuation signal between first and second states in which force is exerted or not exerted inward on the pumping pouch such that when force is exerted inward on the pumping pouch, at least a portion of the pumping pouch is squeezed to force at least a portion of the blood out through the opening. The ventricular assist device further also comprises a frame including an upper ring coupled to the pumping pouch along an edge of the opening, the frame being configured to be coupled to a wall of the heart. The ventricular assist device further also comprises a controller electrically coupled to the contraction element, the controller comprising a processor configured to receive, in use, a signal from a sensor configured to sense beating of the heart and to synchronize actuation of the contraction element between the first and second states with the beating of the heart. BRIEF DESCRIPTION OF THE DRAWINGS FIGURE 1 shows a ventricular assist device 1000 in place in a left ventricle of the heart.FIGURE 2A shows one embodiment of ventricular assist device 1000 including a band 1210.FIGURE 2B shows one embodiment of ventricular assist device 1000 including a helix 1220.FIGURES 2C-2D show top and side views of one embodiment of ventricular assist device 1000 including a partial band 1230. FIGURE 2E shows partial band 1230 squeezing pumping pouch 1100.FIGURES 2F-2G show top view and side views of one embodiment of ventricular assist device 1000 including a flap 1240. FIGURE 2G shows flap 1240 squeezing pumping pouch 1100.FIGURE 3 shows one embodiment of ventricular assist device 1000 including a side strip 1250.FIGURE 4 shows one embodiment of ventricular assist device 1000 including a bottom strip 1260.FIGURE 5 shows one embodiment of ventricular assist device 1000 including a spring 1270.FIGURE 6 shows a vertical cross-sectional view of ventricular assist device 1000.FIGURES 7-8 show ventricular assist device 1000 in place in a left ventricle of a heart, with the heart in diastole and systole, respectively.FIGURE 9 shows one embodiment of a delivery device 1600. FIGURE 10 shows a cross-sectional view of delivery device 1600, with ventricular assist device 1000 collapsed into a delivery configuration.FIGURES 11-14 show one