US-12623011-B2 - Implantable pump for direct sodium removal therapy having on-board analyte sensor

US12623011B2US 12623011 B2US12623011 B2US 12623011B2US-12623011-B2

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.

Inventors

Ian CROSBIE
Andreas WIRTH
Oliver Goedje

Assignees

DSRCO BV

Dates

Publication Date: 20260512
Application Date: 20221006

Claims (20)

1 . A system for use with a direct sodium removal (DSR) solution for conducting direct sodium removal therapy in a patient, the system comprising: an infusate configured to be introduced into a peritoneal cavity, the infusate comprising a solution having a sodium content less than 35 meq/L and (i) from 0.5 to 50 grams dextrose per 100 ml of aqueous solution, (ii) from 0.5 to 50 grams icodextrin/dextrin per 100 ml of aqueous solution, and (iii) purified water; an analyte sensor configured to output a signal indicative of an analyte concentration associated with the infusate introduced into the peritoneal cavity; and a processor coupled to the analyte sensor and configured to receive the signal indicative of the analyte concentration.
2 . The system of claim 1 , further comprising an implantable pump, wherein the processor is configured to cause the implantable pump to move fluid from the peritoneal cavity responsive either to the output of the analyte sensor or after expiration of a predetermined dwell time.
3 . The system of claim 2 , wherein the implantable pump further comprises a transceiver, a battery, an inlet port, and an outlet port.
4 . The system of claim 3 , further comprising an external charging and communications system for periodically charging the battery and conducting bi-directional data communication via the transceiver.
5 . The system of claim 4 , wherein the external charging and communications system inductively transfers energy to the implantable pump.
6 . The system of claim 2 , further comprising: a peritoneal catheter comprising a first end configured to be disposed in the peritoneal cavity of the patient and a second end configured to be coupled to the implantable pump; and a bladder catheter comprising a first end configured to be coupled to the implantable pump and a second end configured to be disposed in a urinary bladder.
7 . The system of claim 6 , wherein the analyte sensor measures a concentration of the analyte within at least one of: the implantable pump, the peritoneal catheter, the bladder catheter, or the peritoneal cavity.
8 . The system of claim 4 , further comprising a monitoring and control system configured to transfer data to the implantable pump via the external charging and communications system.
9 . The system of claim 2 , wherein the implantable pump comprises a gear pump.
10 . The system of claim 2 , wherein the processor is configured to cause the implantable pump to transfer, or cease transfer of, fluid from the peritoneal cavity when the output of the analyte sensor equals or exceeds a predetermined value.
11 . The system of claim 2 , wherein the processor is configured to cause the implantable pump to transfer, or cease transfer of, fluid from the peritoneal cavity when the output of the analyte sensor equals or falls below a predetermined value.
12 . The system of claim 2 , wherein the processor is configured to compute an amount of analyte removed from the peritoneal cavity by operation of the implantable pump.
13 . The system of claim 2 , further comprising a sensor configured to monitor pressure in a bladder, wherein the processor configured to interrupt transfer of fluid by the implantable pump from the peritoneal cavity to the bladder if the pressure in the bladder exceeds a threshold value.
14 . The system of claim 2 , further comprising a sensor configured to monitor pressure in the peritoneal cavity, wherein the processor further is configured to cease transfer of fluid by the implantable pump from the peritoneal cavity to a bladder if the pressure in the peritoneal cavity falls below a preset limit value.
15 . The system of claim 1 , wherein the analyte sensor is configured to monitor sodium ion concentration or electrical conductivity.
16 . The system of claim 1 , wherein the analyte sensor is configured to monitor a concentration of dextrose or icodextrin/dextrin in fluid in the peritoneal cavity.
17 . The system of claim 1 , wherein the solution further comprises urea or from 0.5 to 50 grams of high molecular weight glucose polymer per 100 ml of aqueous solution or both.
18 . The system of claim 1 , wherein the processor is configured to estimate an amount of sodium transferred from the peritoneal cavity using the output of the analyte sensor.
19 . A system for use with a direct sodium removal (DSR) solution for conducting direct sodium removal therapy in a patient, the system comprising: an infusate configured to be introduced into a peritoneal cavity, the infusate being a solution with a sodium content less than 35 meq/L and consisting of 0.5 to 50 grams dextrose per 100 ml of aqueous solution, 0.5 to 50 grams icodextrin/dextrin per 100 ml of aqueous solution, and purified water; an analyte sensor configured to output a signal indicative of an analyte concentration associated with the infusate introduced into the peritoneal cavity; and a processor coupled to the analyte sensor and configured to receive the signal indicative of the analyte concentration.
20 . A method of performing direct sodium removal (DSR) therapy to remove excess sodium from a patient to reduce fluid overload, the method comprising: introducing an infusate into a peritoneal cavity, the infusate comprising a solution having a sodium content less than 35 meq/L and (i) from 0.5 to 50 grams dextrose per 100 ml of aqueous solution, (ii) from 0.5 to 50 grams icodextrin/dextrin per 100 ml of aqueous solution, and (iii) purified water; monitoring analyte concentration associated with the infusate introduced into the peritoneal cavity using an analyte sensor; and receiving an output from the analyte sensor indicative of the analyte concentration.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 17/650,183, filed Feb. 7, 2022, now U.S. Pat. No. 11,464,891, which is a continuation-in-part of U.S. patent application Ser. No. 17/174,855, filed Feb. 12, 2021, which is a continuation of U.S. patent application Ser. No. 15/985,598, filed May 21, 2018, now U.S. Pat. No. 10,918,778, which claims the benefit of priority of U.S. Provisional Application Ser. No. 62/510,652, filed May 24, 2017, the entire contents of each of which are incorporated herein by reference. FIELD OF THE INVENTION The present invention relates generally to improved systems and methods for conducting direct sodium removal via infusion and removal of a no or low sodium solution administered into a patient's peritoneal cavity to remove sodium and fluid from patients afflicted with heart failure or cardio-renal disease. BACKGROUND Patients afflicted with diverse forms of heart failure and/or cardio-renal disease are prone to the accumulation of additional sodium in body tissues and increased fluid retention. For example, in congestive heart failure, due to dysfunction of the left side or right side of the heart, or both, the body is unable to pump blood with normal efficiency, leading to the reduction of blood pressure in systemic circulation. In an attempt to increase blood pressure, the body retains sodium (and water), which leads to stasis or pooling of blood or fluid in the lungs or liver, edema and/or cardiac hypertrophy. Methods, systems and compositions for directly removing excess sodium and water using a no or low sodium infusate instilled into a patient's peritoneal cavity are described in commonly-assigned U.S. Pat. No. 10,918,778, the entirety of which is hereby incorporated by reference. That patent describes a battery-powered pump, designed to be implanted subcutaneously, that includes an inlet catheter configured to be disposed within a patient's peritoneal cavity and an output catheter configured to be coupled to the patient's bladder. The pump is programmed to periodically actuate to move fluid from the peritoneal cavity to the bladder, where the fluid may be voided during urination. As described in the above-incorporated patent, Direct Sodium Removal (“DSR”) Therapy may be conducted periodically, e.g., daily or once weekly, to remove excess sodium and fluid from a patient to reduce fluid-overload, edema, and to reduce cardiac effort in patients with heart failure, such as Heart Failure with reduced Ejection Fraction (“HFrEF”). To conduct such therapy, a quantity, e.g., 0.5 to 1 liters, of a no or low sodium DSR solution is instilled into the patient's peritoneal cavity for a specified dwell period, such as two hours. Dwell time, however may be as long as 24 h, depending on type of DSR infusate used. During the dwell period, the DSR solution creates a sodium gradient that draws excess sodium from the patient's tissues and/or bloodstream into the peritoneal cavity, along with a corresponding volume of ultrafiltrate, e.g., water. At the conclusion of the dwell period, the implantable pump is actuated to move the now sodium-rich DSR solution and ultrafiltrate from the peritoneal cavity to the bladder. As observed in the above-incorporated patent and in initial human clinical testing, DSR therapy can reduce physiologically significant amounts of sodium and fluid from the patient, thereby reducing fluid overload and improving cardiac function. One drawback of DSR therapy as described in the above patent is the use of a dwell period for the DSR solution in the patient's peritoneal cavity that is based on the physician's prior clinical experience and assessment of the patient's physiology. However, in view of the complexity and variability of human anatomy, it would be desirable to adapt the general DSR therapy to address the physiologic needs of specific patients. For example, some patients may have a high level of excess sodium stored in extravascular spaces, e.g., in interstitial spaces and tissues, whereas others may not. Consequently, using a predetermined dwell period for a DSR solution to remain in a patient's peritoneal cavity, e.g., 2 hours, may be suitable for one patient, too long for another, and too short for yet a different patient. Accordingly, it would be desirable to equip the implantable pump used for DSR therapy with a feature that can assess the progress of the therapy, and actuate the pump to move the sodium rich DSR solution and ultrafiltrate to the patient's bladder after a predetermined goal or target is attained, independent of dwell time. Further, it may be desirable to use conduct DSR therapy for a specific patient using DSR solutions having different compositions, e.g., concentrations of dextrose or dextrin, at different times. It therefore would be desirable to adapt the dwell time for DSR therapy to meet the specific physiologic needs and characteristics of a patient, as well as to account