Implantable Sodium-Sensing Pump for Adaptive DSR Therapy
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Solution Overview
Problem
Existing DSR therapy for patients with heart failure and cardio-renal disease lacks adaptability to individual patient physiology and DSR solution composition, leading to suboptimal dwell times and potential hyponatremia risks.
Innovation Solution
An implantable pump equipped with an analyte sensor to monitor sodium concentration in the peritoneal cavity, actuating pump operation based on target analyte levels to ensure precise removal of excess sodium and fluid, independent of predetermined dwell times, and adjusting for different DSR solution compositions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a predetermined dwell period is used for DSR solution in the peritoneal cavity, then the treatment protocol is simple to implement, but the treatment effectiveness varies across individual patients
Solution Approach 1:
The patent implements a feedback mechanism where the implantable pump continuously monitors sodium concentration in the peritoneal cavity and automatically adjusts the dwell time of DSR solution based on real-time sodium levels. This closed-loop control system replaces fixed predetermined dwell periods with dynamic, patient-specific timing that responds to actual physiological conditions, thereby improving treatment effectiveness while maintaining system simplicity through automation
Solution Approach 2:
The patent transitions from static predetermined dwell periods to dynamic dwell time adjustment based on real-time sodium concentration monitoring. The system adapts the dwell time continuously according to patient-specific physiological responses, allowing the treatment protocol to be both simple to implement (automated) and reliably effective (personalized)
2Adaptability or versatility
If real-time sodium monitoring is implemented, then treatment can be tailored to individual patient needs, but device complexity increases
Solution Approach 1:
The patent combines multiple functions into a single implantable device: the pump mechanism for DSR solution delivery, the analyte sensor for sodium concentration monitoring, and the control system for automated dwell time adjustment are integrated into one unified implantable system. This merging reduces the need for separate external monitoring equipment and simplifies the overall treatment system while enabling personalized therapy
Solution Approach 2:
The implantable pump system performs self-monitoring and self-adjustment of treatment parameters based on real-time sodium concentration feedback. The device autonomously determines optimal dwell times and adjusts its operation without requiring external intervention or complex external monitoring systems, thereby achieving personalization without proportionally increasing overall system complexity
3Loss of time
If fixed dwell time is used for sodium removal, then treatment duration is predictable, but risk of hyponatremia increases
Solution Approach 1:
The patent employs real-time sodium concentration monitoring with feedback control to prevent hyponatremia. The system continuously measures sodium levels in the peritoneal cavity and automatically terminates the dwell period when target sodium concentration is achieved, rather than adhering to a fixed predetermined time. This feedback mechanism ensures treatment duration is predictable enough for planning but flexible enough to prevent harmful over-removal of sodium
Solution Approach 2:
The patent implements safety mechanisms that preemptively prevent hyponatremia by monitoring sodium concentration trends and adjusting dwell time before dangerous levels are reached. The system includes predetermined safety thresholds and automatic termination protocols that cushion against the risk of excessive sodium removal, allowing predictable treatment planning while protecting against harmful outcomes
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enhances patient comfort and safety by tailoring therapy to individual needs, preventing hyponatremia and ensuring efficient sodium and fluid removal while maintaining stable serum sodium levels.
Implementation Method 1
an analyte sensor configured to detect a concentration of sodium in the fluid in the peritoneal cavity
Implementation Method 2
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
Data Source
AI summary
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.