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EP-4735093-A1 - SYSTEMS AND METHOD FOR IMPROVING CARDIORENAL SYNDROME

EP4735093A1EP 4735093 A1EP4735093 A1EP 4735093A1EP-4735093-A1

Abstract

Systems and techniques for improving cardiorenal syndrome (CRS) may be provided. The systems may include a first flow enhancer configured to increase a renal artery' pressure. The systems may include a second flow enhancer or flow restrictor configured to reduce a renal vein pressure. Each flow enhancer or flow restrictor may be configured to increase atransrenal pressure gradient, improve filtering and renal perfusion.

Inventors

  • CUCHIARA, Michael
  • KIM, Soo, Young
  • UNUDURTHI, Sathya, Dev
  • Westenfeld, Ralf

Assignees

  • Abiomed, Inc.

Dates

Publication Date
20260506
Application Date
20240628

Claims (20)

  1. 1 . A system for improving renal function, comprising: a first flow modifier configured to increase a renal artery pressure; and/or a second flow modifier configured to reduce a renal vein pressure; wherein the system is configured to increase a transrenal pressure gradient, increase renal perfusion, spare renal injury, improve renal function, or a combination thereof.
  2. 2. The system of claim 1, wherein the first flow modifier is a microaxial pump.
  3. 3. The system of claim 2, wherein the microaxial pump has an inlet in a superior portion of an inferior vena cava (IVC) or right atrium (RA), and an outlet in a pulmonary artery.
  4. 4. The system of claim 2. wherein the microaxial pump has an inlet in an inferior vena cava (IVC) superior to a renal vein, and an outlet in the inferior vena cava (IVC) or right atrium (RA).
  5. 5. The system of claim 4. further comprising an artificial valve disposed between the inlet and the outlet.
  6. 6. The system of claim 5, wherein the artificial valve is a balloon.
  7. 7. The system of claim 5, wherein the artificial valve is a covered stent valve.
  8. 8. The system of claim 1, wherein the first flow modifier is a passive, nonpowered, wing or nozzle.
  9. 9. The system of claim 1, wherein the second flow modifier is a microaxial pump.
  10. 10. The system of claim 9, wherein the microaxial pump has an inlet in a left ventricle (LV) and an outlet in an aorta.
  11. 11. The system of claim 9, wherein the microaxial pump has an inlet in a descending aorta and an outlet superior to a renal artery.
  12. 12. The system of claim 11, further comprising an artificial valve disposed between the inlet and the outlet.
  13. 13. The system of claim 12, wherein the artificial valve is a balloon.
  14. 14. The system of claim 12, wherein the artificial valve is a covered stent valve.
  15. 15. The system of claim 1, wherein the second flow modifier is a passive, nonpowered, wing or nozzle.
  16. 16. The system of claim 1, wherein the second flow modifier is a balloon.
  17. 17. The system of claim 1, wherein the first flow modifier is operably coupled to a controller.
  18. 18. The system of claim 17, wherein the controller is configured to receive information from a sensor and, based on the information, determine when a heart is in diastole.
  19. 19. The system of claim 18, wherein the controller is configured to increase flow generated by the first flow modifier during diastole.
  20. 20. A method for improving renal function, comprising: increasing a transrenal pressure gradient by increasing a renal artery’ pressure, decreasing a renal vein pressure, or a combination thereof to increase renal perfusion, spare renal injury', and improve renal function.

Description

SYSTEMS AND METHOD FOR IMPROVING CARDIORENAL SYNDROME CROSS-REFERENCE TO RELATED APPLICATIONS The present application claims priority to U.S. Provisional Patent Application Nos. 63/523,893, filed 28 June 2023, and 63/604,024, filed 29 November 2023, the contents of which are each incorporated by reference herein in its entirety. TECHNICAL FIELD The present application is drawn to systems for treating or preventing cardiorenal syndrome, such as to systems of flow modifiers (such as flow enhancers or restrictors) configured to spare renal injury and improve renal function by, e.g., increasing a transrenal pressure gradient, and/or improving renal perfusion. BACKGROUND Cardiorenal syndrome (CRS) encompasses a spectrum of acute or chronic disorders of heart and kidney function characterized by mutual deterioration, although it can be classified by which organ initiates CRS. For example, acute or chronic disfunction in one organ can induce acute or chronic disfunction in the other organ. In one example, cardiac initiated CRS may include a condition in which acute heart failure or acute coronary syndrome leads to a decline in renal function, such as in Glomerular Filtration Rate (GFR) (i.e., Type I CRS). In another example, chronic heart failure may result in chronic kidney disease (i.e., Type II CRS). An example of renal initiated CRS could be situations acute renocardiac syndrome, where acute kidney injury leads to CRS (i.e., Type III CRS) or chronic renocardiac syndrome where chronic kidney disease leads to chronic HF (i.e., Type IV CRS). Finally, CRS can occur secondary to non-renal or non- cardiac initiators such as amyloidosis, sepsis, cirrhosis (i.e., Type V CRS). BRIEF SUMMARY In various aspects, a system for improving renal function and sparing renal injury may be provided. The system may include flow modifiers, not limited to flow enhancers or restrictors (which includes both flow reducers and blockers), where the flow modifiers may each, independently, be configured to increase a renal artery pressure, increase renal blood flow, reduce renal vein pressure, and/or increase renal blood flow, etc. The system may include a first flow modifier, which in some embodiments may be a flow enhancer configured to increase a renal artery pressure and renal blood flow. The system may include a second flow modifier, which may be a flow enhancer or restrictor configured to reduce a renal vein pressure and increase renal blood flow. Each flow modifier may be configured to increase a transrenal pressure gradient and/or improve renal perfusion, thereby sparing renal injury and improving renal function (including GFR/filtering, diuresis, natriuresis, etc.). The first flow modifier may be a passive, non-powered, wing or nozzle. The first flow modifier may be a microaxial pump. The microaxial pump may have an inlet in a superior portion of an inferior vena cava (IVC) or right atrium (RA), and an outlet in a pulmonary artery. The microaxial pump may have an inlet in an inferior vena cava (IVC) superior to a renal vein, and an outlet in the inferior vena cava (IVC) or right atrium (RA). The distance between microaxial pump inlet and outlet (e.g., cannula length) may be adjusted to (1) control where the inlet and outlet fall in the vascular and cardiac system (2) modulate recirculation between inlet and outlet, (3) modulate resistance to flow through the cannula. An artificial valve (such as a balloon or stent valve) may be disposed between the inlet and the outlet. The first flow modifier may be operably coupled to a controller. The controller may be configured to receive information from a sensor. The controller may be configured to, based on the information, determine when a heart is in diastole. The controller may be configured to increase flow generated by the first flow modifier during diastole. The second flow modifier may be a passive, non-powered, wing or nozzle. The second flow modifier may be a microaxial pump. The microaxial pump may have an inlet in a left ventricle (LV) and an outlet in an aorta. The microaxial pump may have an inlet in a descending aorta and an outlet superior to a renal artery. An artificial valve (such as a balloon or stent valve) may be disposed between the inlet and the outlet. The flow restrictor may be a balloon. In various aspects, a method for improving renal function and sparing renal injury may be provided. The method may include increasing a transrenal pressure gradient by increasing a renal artery pressure, decreasing a renal vein pressure, or a combination thereof to increase renal perfusion, spare renal injury, and improve renal function. The method may include providing a first flow modifier, as disclosed herein, configured to increase a renal artery pressure. The method may include inserting the first flow modifier such that an inlet may be disposed in a superior portion of an inferior vena cava (IVC) or right atrium (RA), and an outlet may be disposed in a pulmonary artery. Th