Multi-Reservoir Port with Dual-Durometer Septa for High-Flow Hemodialysis

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Conventional multi-reservoir port systems face challenges in maintaining balanced intraluminal pressure during high-flow applications like hemodialysis and apheresis, leading to lumen constriction and septum leakage due to high negative pressures, which are exacerbated by the use of large needles that cause coring and reduce septum puncture life.

Innovation Solution

A multi-reservoir port and non-coring needle system with dual-durometer septa and dual-lumen catheters, featuring non-coring Huber needles and a staggered-tip design, which maintains balanced fluid flow and extends septum puncture life by minimizing coring and optimizing self-sealing capabilities.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If large-bore needles are used to maintain adequate flow rates during high-flow applications, then fluid flow rate is improved, but septum puncture life deteriorates due to coring and high negative pressures

Engineering Contradiction:

Improvefluid flow rateVSAvoidseptum puncture life

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The invention divides the single large-bore needle into multiple smaller-bore needles (e.g., three 19-gauge needles instead of one 16-gauge needle). This segmentation maintains adequate total fluid flow rate while reducing the coring effect on the septum, as each smaller needle causes less damage individually. The combined cross-sectional area of multiple smaller needles approximates that of a single larger needle, preserving flow characteristics while extending septum puncture life.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The invention changes the parameters of needle access by transitioning from a single large-bore needle to multiple smaller-bore needles. This parameter change (from one large aperture to multiple smaller apertures) maintains the necessary total flow cross-section while altering the mechanical interaction with the septum, thereby reducing coring and extending puncture life during high-flow applications.

Inventive Principle:

Principle #35Parameter changes

2Productivity

If high flow rates are required for hemodialysis procedures, then treatment effectiveness is improved, but intraluminal negative pressure increases causing lumen constriction

Engineering Contradiction:

Improveflow rateVSAvoidintraluminal negative pressure

Core Design Contradiction:

ProductivityVSStress or pressure

Solution Approach 1:

The invention segments the fluid withdrawal function across multiple smaller needles rather than using a single large needle. This distribution of flow paths reduces the localized negative pressure effect that causes lumen constriction, while maintaining the total flow rate required for effective hemodialysis treatment.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The invention aims to balance the intraluminal pressures between the aspiration and infusion reservoirs by using multiple smaller needles that create more uniform pressure distribution. This approach reduces extreme negative pressure differentials that lead to lumen constriction and catheter collapse.

Inventive Principle:

Principle #12Equipotentiality

3Ease of operation

If single-port implantation is used to minimize patient discomfort, then ease of operation is improved, but maintaining balanced pressure between reservoirs becomes more difficult

Engineering Contradiction:

Improvepatient comfortVSAvoidpressure balance

Core Design Contradiction:

Ease of operationVSStress or pressure

Solution Approach 1:

The invention uses multiple smaller needles accessing the same aspiration reservoir within a single port, rather than requiring separate ports. This segmentation approach allows the system to maintain pressure balance through optimized needle configuration while preserving the benefits of single-port implantation for patient comfort.

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

The system achieves optimal flow rates and prolonged septum integrity, reducing patient discomfort and medical costs by allowing single-site access and delaying or avoiding port replacements, while maintaining effective fluid circulation during prolonged procedures.

Implementation Method 1

The first and second septa comprise a dual-durometer elastomeric material. The dual-durometer elastomeric material may comprise a first layer with a first durometer and a second layer with a second durometer.

Methodology Applied

Scientific EffectDurometer (hardness measurement): Shore Durometer

Implementation Method 2

The self-sealing septum allows the reservoir to be accessed by puncturing both the patient's skin and the septum with a needle, for example, to infuse and/or aspirate fluid to and from the distal tip of the catheter.

Methodology Applied

Scientific EffectSelf-sealing: Elastic Recovery

Implementation Method 3

Methodology Applied

Scientific EffectFluid flow balance: Pressure Gradient

Data Source

PatentUS10166321B2High-flow port and infusion needle systems

Publication Date: 2019.01.01 ANGIODYNAMICS INC

AI summary

The present invention relates to a multi-reservoir port, catheter and non-coring needle systems that support high-flow applications such as hemodialysis and apheresis. In particular, the present invention relates to improvements to each of these systems to provide optimal flow rates and septum life with minimal intraluminal pressure; both individually and in combination.