Ambulatory CSF Drainage Valve Assembly with Diaphragm Chamber

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Solution Overview

Problem

Current methods for diagnosing and treating Normal Pressure Hydrocephalus (NPH) require invasive procedures and immobilization of patients for CSF drainage tests, which are resource-intensive and limit the ability to simulate continuous shunt performance.

Innovation Solution

A portable valve assembly and pump system that allows controlled, ambulatory cerebrospinal fluid (CSF) drainage using a diaphragm chamber with actuable chambers and a motor-actuated valve plug, enabling continuous fluid communication between the inlet, outlet, and chamber cavities, and a collapsible reservoir for fluid collection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of moving object

If inpatient multi-day drainage trial with temporary catheter is performed, then substantially continuous CSF drainage can be achieved, but patient immobilization and nurse attendance are required, consuming valuable healthcare resources

Engineering Contradiction:
Improvedrainage durationVSAvoidpatient immobilization requirement
Core Design Contradiction:
Duration of action of moving objectVSDevice complexity

Solution Approach 1:

The portable drainage device enables patients to perform CSF drainage autonomously without requiring continuous nurse attendance or patient immobilization. The device includes self-contained components that allow the patient to manage their own drainage therapy in an ambulatory setting, eliminating the need for institutional resources during the drainage trial.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The device transitions from static inpatient drainage systems to a dynamic portable system that can be moved and used in various settings. The portable design with removable components allows the patient to mobility while maintaining continuous drainage capability, eliminating the need for patient immobilization.

Inventive Principle:
Principle #15Dynamics

2Ease of operation

If outpatient lumbar tap test is performed, then patient mobility is maintained, but only very short simulation of drainage is achieved

Engineering Contradiction:
Improvepatient mobilityVSAvoiddrainage simulation duration
Core Design Contradiction:
Ease of operationVSDuration of action of moving object

Solution Approach 1:

The portable device enables continuous CSF drainage over extended periods while the patient remains mobile and engaged in normal activities. The system maintains uninterrupted drainage action throughout the trial period, providing prolonged simulation of shunt performance rather than the brief drainage of outpatient lumbar taps.

Inventive Principle:
Principle #20Continuity of useful action

3Duration of action of moving object

If inpatient drainage trial is performed, then substantially continuous CSF drainage is achieved, but healthcare resources are consumed

Engineering Contradiction:
Improvecontinuous drainage capabilityVSAvoidhealthcare resource consumption
Core Design Contradiction:
Duration of action of moving objectVSQuantity of substance

Solution Approach 1:

The device eliminates the need for continuous nurse attendance and institutional infrastructure by enabling self-managed drainage therapy. Patients can perform drainage trials independently in their own homes or community settings, dramatically reducing the quantity of healthcare resources required while maintaining continuous drainage capability.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The portable device acts as an intermediary between the patient and the healthcare system, enabling drainage therapy to occur outside of institutional settings. This mediator function allows continuous drainage to be achieved without consuming valuable healthcare resources for infrastructure and personnel.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Ease of operation

If portable valve assembly with diaphragm chamber is used, then ambulatory CSF drainage is enabled, but device complexity increases

Engineering Contradiction:
Improveambulatory capabilityVSAvoidvalve assembly structure
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The valve assembly is divided into separate functional modules including a diaphragm chamber, valve body, and actuation mechanisms. This segmentation allows each component to be optimized independently and facilitates easier manufacturing, assembly, and maintenance while enabling ambulatory use. The modular design reduces overall system complexity despite the advanced functionality.

Inventive Principle:
Principle #1Segmentation

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

Enables continuous, controlled CSF drainage that simulates the effect of an implanted shunt, allowing patients to ambulate freely while reducing healthcare resource consumption and improving diagnostic accuracy.

Implementation Method 1

a diaphragm dividing the diaphragm chamber into a first chamber cavity and a second chamber cavity. The diaphragm being deflectable toward a first wall of the diaphragm chamber wherein the first chamber cavity contracts and the second chamber cavity expands

Methodology Applied
Scientific EffectPressure differential: Pressure Gradient

Data Source

PatentUS20230256227A1Ambulatory fluid drainage and collection device
Publication Date: 2023.08.17 THE CLEVELAND CLINIC FOUND
  • US20230256227A1 patent drawing
  • US20230256227A1 patent drawing
  • US20230256227A1 patent drawing

AI summary

A valve assembly for controlled drainage or delivery of a fluid from or to a patient including a first port (182), a second port (184), a diaphragm chamber and a diaphragm (132) dividing the diaphragm chamber into a first chamber cavity (158A) and a second chamber cavity (158B). The diaphragm being deflectable toward a first wall of the diaphragm chamber wherein the first chamber cavity contracts and the second chamber cavity expands, and oppositely toward a second wall of the diaphragm chamber wherein the second chamber cavity contracts and the first chamber cavity expands. A valve (212) is actuatable between a first actuation state that establishes fluid communication between the first port and the second chamber cavity and separately between the second port and the first chamber cavity. The valve also having a second actuation state that establishes fluid communication between the first port and the first chamber cavity, and separately between the second port and the second chamber cavity.