Elastomeric Tube Seal for Needle-Free PRP Extraction

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Solution Overview

Problem

Current methods for preparing Platelet Rich Plasma (PRP) are inefficient due to the need for needles and separating gels, which lead to RBC contamination and increased costs, and often result in suboptimal PRP production as they require multiple centrifugation steps and complex fluid transfer processes.

Innovation Solution

A method involving a tube seal and barrel system that allows for needle-free transfer of fluid layers from specimen tubes to syringes, eliminating the need for separating gels and reducing contamination risks, by using a Luer-compatible connector and elastomeric tube seal to precisely extract and transfer plasma and buffy coat layers without RBC contamination.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If needles and separating gels are used for fluid transfer, then RBC contamination is reduced, but device complexity and cost increase

Engineering Contradiction:
Improvecontamination preventionVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention extracts and eliminates the need for needles and separating gels from the fluid transfer system. The connector achieves needle-free transfer by using a simple elastomeric tube seal that engages with the specimen tube to create a sealed pathway for fluid extraction, removing complex components while maintaining contamination prevention

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The elastomeric tube seal automatically creates a sealed connection when engaged with the specimen tube, and the fluid transfer is driven by the pressure differential created during centrifugation. The system self-regulates to prevent RBC contamination without requiring additional control mechanisms or complex components

Inventive Principle:
Principle #25Self-service

2Manufacturing precision

If multiple centrifugation steps are used, then PRP concentration is improved, but loss of time increases

Engineering Contradiction:
ImprovePRP concentrationVSAvoidloss of time
Core Design Contradiction:
Manufacturing precisionVSLoss of time

Solution Approach 1:

The connector is designed to facilitate rapid fluid transfer between centrifugation steps, and the two-spin protocol is optimized to perform preliminary separation of RBCs in the first spin, then quickly transfer the supernatant for final PRP concentration in the second spin, minimizing idle time between critical operations

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The connector enables continuous fluid transfer operations between centrifugation steps without requiring discontinuous manual transfer procedures. The streamlined connection system maintains momentum in the PRP production process, reducing non-productive time while preserving the necessary two-step concentration protocol

Inventive Principle:
Principle #20Continuity of useful action

3Ease of operation

If needles are used for fluid aspiration, then fluid transfer is achieved, but safety and ease of operation worsen

Engineering Contradiction:
Improvefluid transferVSAvoidsafety risks
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The invention replaces the mechanical needle-based aspiration system with a connector system that uses an elastomeric tube seal to create a sealed pathway. Fluid transfer is achieved through pressure differential rather than mechanical puncture, eliminating needle-related safety hazards while maintaining operational effectiveness

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The elastomeric tube seal acts as an intermediary between the connector and the specimen tube, creating a safe sealed connection that eliminates the need for direct needle penetration. This intermediary component enables fluid transfer while protecting operators from needlestick injuries and bloodborne pathogen exposure

Inventive Principle:
Principle #24Intermediary (Mediator)

4Reliability

If separating gel is used, then RBC contamination is prevented, but operational costs increase

Engineering Contradiction:
Improvecontamination preventionVSAvoidoperational cost
Core Design Contradiction:
ReliabilityVSLoss of substance

Solution Approach 1:

The invention extracts and eliminates the need for separating gel from the system. The elastomeric tube seal creates a physical barrier and sealed pathway that prevents RBC contamination without requiring chemical separating agents, thereby removing the cost associated with gel materials while maintaining contamination prevention

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The connector with elastomeric tube seal is designed as a simple, low-cost, potentially disposable component that replaces expensive separating gel materials. The connector achieves contamination prevention through mechanical sealing rather than chemical barriers, reducing material costs while maintaining reliability

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

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 method enables precise, cost-effective, and safer transfer of PRP components, allowing for optimal two-spin PRP production without needles or separating gels, reducing contamination risks and operational costs, and improving the efficiency of PRP preparation.

Implementation Method 1

the tube undergoes a first spin cycle (hereinafter 'first spin') in the centrifuge and the whole blood is separated into three broad fractions

Methodology Applied
Scientific EffectCentrifugal separation: Centrifugal Separation

Implementation Method 2

the elastomeric member having an outer diameter sized to sealingly engage with an inner surface of the specimen tube

Methodology Applied
Scientific EffectElastic sealing: Elasticity

Data Source

PatentUS12023425B2Connector for creating platelet rich plasma
Publication Date: 2024.07.02 KOWALEWSKI RYSZARD DR
  • US12023425B2 patent drawing
  • US12023425B2 patent drawing
  • US12023425B2 patent drawing

AI summary

Method for transferring one or more portions of fluid from a specimen tube, comprising: providing an elongate connector comprising an elongated tube having a lumen or through-hole extending between proximal and distal ends thereof, a Luer-compatible female taper provided on the proximal end of the connector, a flange provided proximate the distal end of the connector; providing a tube seal mounted on the distal end of the connector, the tube seal comprising an elastomeric member having a longitudinal axis, a proximal end, a distal end, and a through-hole extending therebetween, the distal end having a frustoconical or chamfered face forming a funnel, the elastomeric member having an outer diameter sized to sealingly engage with an inner surface of the specimen tube; advancing the distal end of the connector and the tube seal into the specimen tube, the funnel directing the first layer into the through-hole of the connector.