EP-4735094-A1 - CARDIORENAL SYNDROME (CRS) THERAPY SYSTEMS AND METHODS

Abstract

A system and method for cardiorenal syndrome (CRS) therapy are provided. The system may utilize a therapy-delivery device configured to be disposed within a patient. The therapy-delivery device may be, e.g , a blood pump, a blood flow or pressure restrictor or enhancer. The system may include a controller operably coupled to the therapy-delivery device. The controller may be configured to adjust a therapy delivered by the therapy-delivery device based on a parameter related to renal function. The parameter may be measured by a real-time diagnostic sensor. The real-time diagnostic sensor may be integral to the therapy-delivery device, or may be located remotely from the therapy-delivery device, such as on a separate implantable device, or on a wearable medical device.

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 cardiorenal syndrome (CRS) therapy, comprising: a therapy-delivery device configured to be disposed within a patient, where the therapy- delivery device is a blood pump, a blood flow or pressure restrictor or enhancer; a controller operably coupled to the therapy -delivery’ device, where the controller is configured to adjust a therapy delivered by the therapy-delivery device based on a parameter related to renal function.
2. 2. The system of claim 1, wherein the therapy-delivery device is a blood pump disposed in a blood vessel forming part of a patient’s arterial circulation.
3. 3. The system of claim 1, wherein the therapy-delivery' device is a blood pump disposed in a blood vessel forming part of a patient's venous circulation.
4. 4. The system of claim 1. wherein the therapy-delivery device is a blood flow or pressure restrictor disposed in a blood vessel forming part of a patient’s arterial circulation.
5. 5. The system of claim 1. wherein the therapy-delivery device is a blood flow or pressure restrictor disposed in a blood vessel forming part of a patient’s venous circulation.
6. 6. The system of claim 1, wherein the therapy-delivery device is a blood flow or pressure enhancer disposed in a blood vessel forming part of a patient’s arterial circulation.
7. 7. The system of claim 1, wherein the therapy-delivery device is a blood flow or pressure enhancer disposed in a blood vessel forming part of a patient’s venous circulation.
8. 8. The system of claim 1, wherein the therapy-delivery device is a blood pump disposed in a blood vessel forming part of a patient’s arterial circulation and a valve like structure is used to separate the inlet and outlet and improve pump hydrodynamic performance.
9. 9. The system of claim 1, wherein the therapy-deli very device is a blood pump disposed in a blood vessel forming part of a patient’s venous circulation and a valve like structure is used to separate the inlet and outlet and improve pump hydrodynamic performance.
10. 10. The system of claim 1, wherein the parameter related to renal function is a hemodynamic parameter, a renal function parameter, or a combination thereof.
11. 1 1. The system of claim 8, wherein the hemodynamic parameter is renal blood flow, cardiac index, or a combination thereof.
12. 12. The system of claim 8, wherein the renal function parameter is serum creatinine concentration, urine creatinine concentration, blood urea nitrogen (BUN), urinary output, net fluid output (fluid input - urine output), serum sodium concentration, urinary sodium concentration, total urinary' sodium content, blood concentration or hematocrit, change in body weight, estimated glomerular filtration rate (eGFR), direct glomerular filtration rate (GFR). a renal injury marker, or a combination thereof.
13. 13. The system of claim 10, wherein the renal injury marker is Neutrophil gelatinase- associated lipocalin (NGAL), Cystatin C, TIMP-2, IGFBP-7, KIM 1, or a marker of renal oxygenation.
14. 14. The system of claim 1, wherein the controller is configured to receive data from a user, the data including the parameter related to renal function.
15. 15. The system of claim 1. wherein the controller is configured to receive the parameter related to renal function from a real-time diagnostic sensor.
16. 16. The system of claim 13, wherein the real-time diagnostic sensor is integrated into the therapy -delivery device.
17. 17. The system of claim 13, wherein the real-time diagnostic sensor is a separate device from the therapy -delivery device.
18. 18. The system of claim 15, wherein the separate device is an implantable device.
19. 19. The system of claim 15, wherein the separate device is a wearable device.
20. 20. The system of claim 13, wherein the real-time diagnostic sensor is configured to detect an optical change in response to a measured biomarker.

Description

CARDIORENAL SYNDROME (CRS) THERAPY SYSTEMS AND METHODS CROSS-REFERENCE TO RELATED APPLICATIONS The present application claims priority to U.S. Provisional Patent Application No. 63/523,893, filed 28 June 2023, the contents of which are incorporated by reference herein in its entirety. TECHNICAL FIELD The present disclosure is drawn to CRS therapies, such as techniques for selecting and/or modifying a therapy (<?.g. , via mechanical circulatory support devices) based at least in part on monitored parameters related to renal function. BACKGROUND Cardiorenal syndrome (CRS) describes disorders involving both the heart and kidneys, in which acute or chronic dysfunction in one organ may induce acute or chronic dysfunction in the other organ. CRS represents heart-kidney interactions which in part are described by bidirectional hemodynamic crosstalk between the heart and the kidneys, as well as neurohormonal signaling. BRIEF SUMMARY In various aspects, a system for cardiorenal syndrome (CRS) therapy may be provided. The system may include a therapy-delivery device configured to be disposed within a patient. The therapy-delivery device may be a blood pump, a blood flow or pressure restrictor or enhancer. The system may include a controller operably coupled to the therapy-delivery device. The controller may be configured to adjust a therapy delivered by the therapy-delivery device based on a parameter related to renal function. The therapy-delivery device may be a blood pump disposed in a blood vessel forming part of a patient’s arterial circulation or venous circulation. The therapy-delivery' device may be a blood flow or pressure restrictor disposed in a blood vessel forming part of a patient’s arterial circulation or venous circulation. The therapy-delivery device may be a blood flow or pressure enhancer disposed in a blood vessel forming part of a patient’s arterial circulation or venous circulation. The parameter related to renal function may be a hemodynamic parameter, a renal function parameter, or a combination thereof. The hemodynamic parameter may be renal blood flow, cardiac index, or a combination thereof. The renal function parameter may be serum creatinine concentration, urine creatinine concentration, blood urea nitrogen (BUN), urinary output, net fluid output (fluid input - urine output), serum sodium concentration, urinary’ sodium concentration, total urinary’ sodium content, blood concentration or hematocrit, change in body weight, estimated glomerular filtration rate (eGFR), direct glomerular filtration rate (GFR), a renal injury' marker, or a combination thereof. The renal injury marker may be Neutrophil gelatinase-associated lipocalin (NGAL) or Cystatin C. The controller may be configured to receive data from a user (e.g., user-entered data), the data including the parameter related to renal function. The controller may be configured to receive the parameter related to renal function from a real-time diagnostic sensor. The real- time diagnostic sensor may be integrated into the therapy -delivery device. The real-time diagnostic sensor may be a separate device from the therapy-delivery’ device. The separate device may be an implantable device. The separate device may be a wearable device. The real-time diagnostic sensor may be configured to detect an optical change in response to a measured biomarker. The real-time diagnostic sensor may be configured to detect a change in electrical properties in response to a measured biomarker. The real-time diagnostic sensor may be configured to detect a mechanical change in response to a measured biomarker. Adjusting the therapy may include increasing or decreasing therapy dose. Increasing or decreasing the therapy dose may include increasing or decreasing a rotational speed of a blood pump. Adjusting the therapy may include increasing or decreasing an intended duration of therapy. Adjusting the therapy may include increasing or decreasing a duty cycle of therapy. The controller may be configured to determine adequacy of therapy withdrawal timing and duration. In various aspects, a method for cardiorenal syndrome (CRS) therapy may be provided. The method may include disposing a therapy-delivery device within a patient. The therapy-delivery device may be a blood pump, a blood flow or pressure restrictor or enhancer. The method may include receiving information related to renal function. The method may include adjusting a therapy delivered by the therapy-deli very device based on information related to renal function. The therapy-delivery device may be a blood pump disposed in a blood vessel forming part of a patient's arterial circulation or venous circulation. The therapy-delivery device may be a blood flow or pressure restrictor disposed in a blood vessel forming part of a patient’s arterial circulation or venous circulation. The therapy-delivery device may be a blood flow or pressure enhancer disposed in a blood vessel forming part of a patient’s arterial