Implantable Access Port Deformable Septum Clotting Prevention

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Solution Overview

Problem

Existing subcutaneous access ports for implantation in patients face challenges with fluid flow and clotting, leading to occlusions in attached catheters, which compromise system patency.

Innovation Solution

The access port is designed with a deformable septum and a stem configuration that includes a cylindrical extension to compensate for volume changes during needle insertion and removal, preventing blood ingress and maintaining reservoir volume, along with tapered fluid outlets to reduce pressure and improve flow.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a traditional access port is used with a rigid septum, then the structure is simple and easy to manufacture, but blood ingress occurs during needle removal causing clotting and catheter occlusion

Engineering Contradiction:
Improvecatheter patencyVSAvoidport structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies the dynamics principle by replacing the traditional rigid septum with a deformable membrane that can dynamically change shape in response to needle insertion and removal. The membrane deforms to accommodate the needle during insertion, then returns to its original shape upon removal, actively preventing blood ingress and maintaining catheter patency through its dynamic response rather than a static structure.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent implements this principle by using a flexible deformable membrane as the sealing element instead of a rigid septum. This thin film structure allows the membrane to bend and deform during needle manipulation while maintaining the seal integrity, preventing blood from entering the catheter system during the needle removal process.

Inventive Principle:
Principle #30Flexible shells and thin films

2Reliability

If the reservoir volume is allowed to change during needle manipulation, then the device is simpler, but blood ingress occurs leading to clotting

Engineering Contradiction:
Improveprevention of blood ingressVSAvoidvolume compensation mechanism
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The deformable membrane acts as a flexible shell that dynamically adjusts the reservoir volume during needle manipulation. When the needle is inserted or removed, the membrane deforms to accommodate the volume changes, preventing blood ingress while maintaining a relatively simple overall device structure without requiring additional active volume compensation mechanisms.

Inventive Principle:
Principle #30Flexible shells and thin films

3Productivity

If conventional fluid outlets are used, then the manufacturing is easier, but fluid flow is restricted and pressure builds up

Engineering Contradiction:
Improvefluid flow rateVSAvoidoutlet configuration
Core Design Contradiction:
ProductivityVSEase of manufacture

Solution Approach 1:

The patent applies segmentation by dividing the fluid outlet into multiple separate outlets instead of using a single conventional outlet. This segmentation increases the total fluid flow capacity and reduces pressure buildup during infusion, while each individual outlet remains simple in structure and easy to manufacture, maintaining ease of production.

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

This design enhances fluid handling by reducing the likelihood of clotting and occlusions, ensuring improved patency of the catheter system and efficient infusion and aspiration processes.

Implementation Method 1

a deformable element included in the reservoir. The deformable element is operably connected to a main portion of the septum and deforms in response to displacement of the septum so as to counteract a change in volume within the reservoir

Methodology Applied
Scientific EffectDeformation: Deformation

Implementation Method 2

tapered fluid outlets to reduce pressure and improve flow

Methodology Applied
Scientific EffectPressure gradient: Pressure Gradient

Data Source

PatentUS11633582B2Implantable access port including fluid handling features
Publication Date: 2023.04.25 CR BARD INC
  • US11633582B2 patent drawing
  • US11633582B2 patent drawing
  • US11633582B2 patent drawing

AI summary

An access port for subcutaneous implantation is typically connected to a catheter, a distal portion of which is disposed within a vein or other vessel of the patient. The access port described herein is configured with enhanced fluid handling features to improve fluid flow therethrough while reducing the likelihood of clotting or occlusions in the attached catheter, thus improving system patency. The access port includes a body defining a reservoir, a needle-penetrable septum covering the top opening of the reservoir, a stem including a lumen in fluid communication with the reservoir, and a volume control device positioned in the reservoir. The volume control device includes a floor designed to move from a first position below the side opening to a second position adjacent the bottom surface, and a spring element positioned between the floor and the bottom surface, the spring element biasing the floor in the first position.