Abstract: A direct sodium removal (“DSR”) infusate regimen and methods of use are provided for removing sodium and reducing fluid overload in patients with severe renal dysfunction and/or heart failure, in which a patient has at least a first DSR session with a first DSR infusate having no or low sodium that is instilled into a patient's peritoneal cavity for a first dwell period to cause sodium and excess fluid to migrate to the patient's peritoneal cavity, and thereafter, the patient may undergo conventional dialysis to rebalance the patient's fluid and sodium levels.

Abstract: A system is provided including an implantable device configured to be implanted subcutaneously within a patient, a clinician monitoring and control device, an optional patient mobile device, a remote server and/or at least one data analyst device used by a data analyst. The implantable device may communicate with any or all of the monitoring and control device, the mobile device and/or the remote server through the charging device or by establishing a direct wireless connection with each such device. The data analyst device may establish a direct connection with the remote server and also may establish a connection with the monitoring and control device and the mobile device. By analyzing and reviewing the data generated by the implantable device, the data analyst may diagnose a medical condition or indicate a heightened risk of a condition.

Abstract: A direct sodium removal (“DSR”) infusate regimen and methods of use are provided for removing sodium and reducing fluid overload in patients with severe renal dysfunction and/or heart failure, in which a patient has at least a first DSR session with a first DSR infusate having no or low sodium that is instilled into a patient's peritoneal cavity for a first dwell period to cause sodium and excess fluid to migrate to the patient's peritoneal cavity, and thereafter, the patient may undergo conventional dialysis to rebalance the patient's fluid and sodium levels.

Abstract: A device and methods for treating renal failure are disclosed. One embodiment of the device is an implantable peritoneal dialysis device. When in use, the device can have a semi-permeable reservoir implanted in the peritoneal cavity. The reservoir can receive blood waste and drain through one or more conduits, via a pump, to the biological bladder. Solids and/or a solution benefiting dialysis can be pumped to the reservoir and/or implanted in the peritoneal cavity.

Abstract: A system includes an implantable device including a pump to pump the fluid from the peritoneum to the bladder via respective catheters, control circuitry, battery and transceiver; a charging and communication system configured to periodically charge the battery and communicate with the implantable device to retrieve data reflective of the patient's health; and monitoring and control software, suitable for use with conventional personal computers, for configuring and controlling operation of the implantable device and charging and communication system. The monitoring and control software allows a treating physician to remotely adjust the volume, time, and frequency with which fluid is pumped from the peritoneal cavity to the bladder based on the data reflective of the patient's health.

Abstract: A direct sodium removal (“DSR”) infusate regimen and methods of use are provided for removing sodium and reducing fluid overload in patients with severe renal dysfunction and/or heart failure, in which a patient has at least a first DSR session with a first DSR infusate having no or low sodium that is instilled into a patient's peritoneal cavity for a first dwell period to cause sodium and excess fluid to migrate to the patient's peritoneal cavity, and thereafter, the patient may undergo conventional dialysis to rebalance the patient's fluid and sodium levels.

Abstract: A Direct Sodium Removal method, apparatus and solution for treating patients in heart failure, and having a glomerular filtration rate greater than 15 mL/min/1.73 m2, or residual kidney function corresponding to normal to CKD Stage 4, is provided in which a no or low sodium DSR infusate is administered to the peritoneal cavity for a predetermined dwell period and then removed, thereby removing sodium from the body. The resulting elimination of fluid from the patient by i) functioning of the kidneys through urination and ii) direct removal of osmotic ultrafiltrate from the peritoneal cavity, restores serum sodium concentrations to healthy levels and thereby reduces fluid overload in the patient.

Abstract: Systems and methods for performing Direct Sodium Removal (DSR) therapy are provided in which an implantable device includes a pump coupled to an inlet catheter designed for placement in a patient's peritoneal cavity, an outlet catheter designed to be coupled to the patient's bladder, and is operably coupled to an analyte sensor, the pump programmed to transfer and/or cease transfer of fluid from the patient's peritoneal cavity to the patient's bladder for voiding responsive to a level of analyte detected by the analyte sensor. In addition, the system may include a processor that computes an amount of analyte transferred per pumping session.

Abstract: A direct sodium removal (“DSR”) infusate regimen and methods of use are provided for removing sodium and reducing fluid overload in patients with severe renal dysfunction and/or heart failure, in which a patient has at least a first DSR session with a first DSR infusate having no or low sodium that is instilled into a patient's peritoneal cavity for a first dwell period to cause sodium and excess fluid to migrate to the patient's peritoneal cavity, and thereafter, the patient may undergo conventional dialysis to rebalance the patient's fluid and sodium levels.

Abstract: Enhanced systems and methods for performing Direct Sodium Removal (DSR) therapy are provided in which an implantable device includes a variable speed motor-driven pump that may be programmed to output different flow rates at different stages of a DSR therapy session, wherein the system monitors operational parameters of the pump and is configured to generate an alarm condition indicative of a fault that may be displayed on a patient's smartphone to permit corrective action, and in which a catheter set implanted with the implantable device enables a DSR solution may be instilled into the patient's peritoneal cavity using a peritoneal catheter that is subsequently used to remove the DSR solution and sodium-rich ultrafiltrate from the peritoneal cavity to the patient's bladder.

Abstract: Systems and methods for performing Direct Sodium Removal (DSR) therapy are provided in which an implantable device includes a pump coupled to an inlet catheter designed for placement in a patient's peritoneal cavity, an outlet catheter designed to be coupled to the patient's bladder, and is operably coupled to an analyte sensor, the pump programmed to transfer and/or cease transfer of fluid from the patient's peritoneal cavity to the patient's bladder for voiding responsive to a level of analyte detected by the analyte sensor. In addition, the system may include a processor that computes an amount of analyte transferred per pumping session.

Abstract: A direct sodium removal (“DSR”) infusate regimen and methods of use are provided for removing sodium and reducing fluid overload in patients with severe renal dysfunction and/or heart failure, in which a patient has at least a first DSR session with a first DSR infusate having no or low sodium that is instilled into a patient's peritoneal cavity for a first dwell period to cause sodium and excess fluid to migrate to the patient's peritoneal cavity, and thereafter, the patient may undergo conventional dialysis to rebalance the patient's fluid and sodium levels.

Abstract: Systems and methods for performing Direct Sodium Removal (DSR) therapy are provided in which an implantable device includes a pump coupled to an inlet catheter designed for placement in a patient's peritoneal cavity, an outlet catheter designed to be coupled to the patient's bladder, and is operably coupled to an analyte sensor, the pump programmed to transfer and/or cease transfer of fluid from the patient's peritoneal cavity to the patient's bladder for voiding responsive to a level of analyte detected by the analyte sensor. In addition, the system may include a processor that computes an amount of analyte transferred per pumping session.

Abstract: A fluid management system for the treatment of ascites, pleural effusion or pericardial effusion is provided including an implantable device including a positive displacement gear pump coupled to an inflow catheter and an outflow catheter, a battery, a processor, and at least one sensor configured to detect a presence of an infection marker, and an external charging and communication system configured to wirelessly communicate transcutaneously with the implantable device. The processor is programmed to periodically activate the pump to move fluid from a first cavity to a second cavity, e.g., the patient's bladder, via the inflow and outflow catheters; receive a signal indicative of the presence of the infection marker from the at least one sensor; generate an alert upon receipt of the signal; and communicate the alert to the external charging and communication system to notify the user.

Abstract: A fluid management system for the treatment of ascites, pleural effusion or pericardial effusion is provided including an implantable device including a pump, control circuitry, battery and transceiver; a charging and communication system configured to periodically charge the battery and communicate with the implantable device to retrieve performance data; and monitoring and control software, suitable for use with conventional personal computers, for configuring and controlling operation of the implantable device and charging and communication system. The implantable device includes a number of features that provide automated movement of fluid to the bladder with reduced risk of clogging, with no patient involvement other than occasional recharging of the battery of the implantable device. The monitoring and control software is available only to the treating physician, such that the physician interacts with the implantable device via the charging and communication system.

Abstract: A Direct Sodium Removal method, apparatus and solution for treating patients in heart failure, and having a glomerular filtration rate greater than 15 mL/min/1.73 m2, or residual kidney function corresponding to normal to CKD Stage 4, is provided in which a no or low sodium DSR infusate is administered to the peritoneal cavity for a predetermined dwell period and then removed, thereby removing sodium from the body. The resulting elimination of fluid from the patient by i) functioning of the kidneys through urination and ii) direct removal of osmotic ultrafiltrate from the peritoneal cavity, restores serum sodium concentrations to healthy levels and thereby reduces fluid overload in the patient.

Abstract: A Direct Sodium Removal method, apparatus and solution for treating patients in heart failure, and having a glomerular filtration rate greater than 15 mL/min/1.73 m2, or residual kidney function corresponding to normal to CKD Stage 4, is provided in which a no or low sodium DSR infusate is administered to the peritoneal cavity for a predetermined dwell period and then removed, thereby removing sodium from the body. The resulting elimination of fluid from the patient by i) functioning of the kidneys through urination and ii) direct removal of osmotic ultrafiltrate from the peritoneal cavity, restores serum sodium concentrations to healthy levels and thereby reduces fluid overload in the patient.

Abstract: A Direct Sodium Removal method, apparatus and solution for treating patients in heart failure, and having a glomerular filtration rate greater than 15 mL/min/1.73 m2, or residual kidney function corresponding to normal to CKD Stage 4, is provided in which a no or low sodium DSR infusate is administered to the peritoneal cavity for a predetermined dwell period and then removed, thereby removing sodium from the body. The resulting elimination of fluid from the patient by i) functioning of the kidneys through urination and ii) direct removal of osmotic ultrafiltrate from the peritoneal cavity, restores serum sodium concentrations to healthy levels and thereby reduces fluid overload in the patient.

Abstract: A system is provided including an implantable device configured to be implanted subcutaneously within a patient, a clinician monitoring and control device, an optional patient mobile device, a remote server and/or at least one data analyst device used by a data analyst. The implantable device may communicate with any or all of the monitoring and control device, the mobile device and/or the remote server through the charging device or by establishing a direct wireless connection with each such device. The data analyst device may establish a direct connection with the remote server and also may establish a connection with the monitoring and control device and the mobile device. By analyzing and reviewing the data generated by the implantable device, the data analyst may diagnose a medical condition or indicate a heightened risk of a condition.

Abstract: A system is provided including an implantable device configured to be implanted subcutaneously within a patient, a clinician monitoring and control device, an optional patient mobile device, a remote server and/or at least one data analyst device used by a data analyst. The implantable device may communicate with any or all of the monitoring and control device, the mobile device and/or the remote server through the charging device or by establishing a direct wireless connection with each such device. The data analyst device may establish a direct connection with the remote server and also may establish a connection with the monitoring and control device and the mobile device. By analyzing and reviewing the data generated by the implantable device, the data analyst may diagnose a medical condition or indicate a heightened risk of a condition.