Hemodialysis Control Architecture for Secure Remote Software Updates

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Solution Overview

Problem

Hemodialysis is inefficient, difficult, and expensive due to its complexity, safety concerns, and the large amount of dialysate required, necessitating improvements in ease and efficiency to impact treatment costs and patient outcomes.

Innovation Solution

A hemodialysis system with a processor configured to communicate with a remote server for protection against unauthorized software, integrated with a water purification system to ensure purified water quality, and fluid circuits that include balancing, mixing, and directing circuits to optimize dialysate preparation and blood flow management.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If hemodialysis systems use complex control software and remote communication capabilities, then functionality and connectivity are improved, but vulnerability to unauthorized or malicious software increases

Engineering Contradiction:
Improveremote communication capabilityVSAvoidmalicious software exposure
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The patent segments the memory system into multiple distinct memory spaces (first memory space and second memory space) with different access permissions. The control software operates in one memory space while the agent module accesses another, isolating potential malicious software impacts and preventing unauthorized propagation across the entire system memory.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces an agent module as an intermediary component that acts as a buffer between the control software and the memory system. This agent module validates and manages access to downloaded files, preventing direct execution of potentially malicious code by the control software while enabling necessary remote communication functions.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If hemodialysis requires large amounts of dialysate solution, then dialysis treatment can be performed, but resource consumption and treatment cost increase

Engineering Contradiction:
Improvedialysis treatment capabilityVSAvoiddialysate volume
Core Design Contradiction:
ProductivityVSQuantity of substance

Solution Approach 1:

The patent implements a balancing circuit that recycles and reuses dialysate solution. Instead of discarding all used dialysate, the system recovers and reprocesses a portion of it, reducing the total volume of fresh dialysate required while maintaining adequate dialysis treatment capability.

Inventive Principle:
Principle #34Discarding and recovering

3Reliability

If hemodialysis systems are operated in dialysis centers with skilled technicians, then safety and treatment quality are improved, but operational complexity and accessibility decrease

Engineering Contradiction:
Improvetreatment safetyVSAvoidoperational simplicity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent implements automated control software that manages dialysis treatment parameters, monitoring, and adjustments without requiring constant technician intervention. The system performs self-diagnosis, automatic parameter optimization, and safety monitoring, enabling safer operation with reduced professional oversight while maintaining treatment quality.

Inventive Principle:
Principle #25Self-service

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 the efficiency and safety of hemodialysis by protecting against malicious software, ensuring purified water quality, and optimizing dialysate preparation and blood flow, thereby reducing treatment costs and improving patient outcomes.

Implementation Method 1

the dialyzer is a type of filter having a semi-permeable membrane, and is constructed such that the blood from the blood flow circuit flows through tiny tubes and the dialysate solution circulates around the outside of the tubes. Therapy is achieved by the passing of waste molecules (e.g., urea, creatinine, etc.) and water from the blood through the walls of the tubes and into the dialysate solution.

Methodology Applied
Scientific EffectDiffusion: Diffusion

Implementation Method 2

Therapy is achieved by the passing of waste molecules (e.g., urea, creatinine, etc.) and water from the blood through the walls of the tubes and into the dialysate solution.

Methodology Applied
Scientific EffectOsmosis: Osmosis

Data Source

PatentUS12026271B2Control systems and methods for blood or fluid handling medical devices
Publication Date: 2024.07.02 DEKA PRODUCTS LP
  • US12026271B2 patent drawing
  • US12026271B2 patent drawing
  • US12026271B2 patent drawing

AI summary

A processor of a medical device configured to communicate with a remote server can be programmed to protect the medical device from exposure to unauthorized or malicious software. A system or method to implement this form of protection can include, for example, at least one processor on the medical device, a control software module that controls the operation of the medical device and is executable on the processor, a data management module that manages data flow to and from the control software module from sources external to the medical device, and an agent module that has access to a limited number of designated memory locations in the medical device. In addition, a hemodialysis apparatus can be configured to operate in conjunction with an apparatus for providing purified water from a source such as a municipal water supply or a well. A system for controlling delivery of purified water to the hemodialysis apparatus can comprise a therapy controller of the hemodialysis apparatus configured to communicate with a controller of a water purification device, and a user interface controller of the hemodialysis apparatus configured to communicate with the therapy controller, and to send data to and receive data from a user interface.