Vacuum Expanded Dry Paste for Rapid Surgical Reconstitution

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Solution Overview

Problem

Conventional methods for preparing haemostatic pastes require time-consuming and mechanically intensive mixing of powder and liquid, which can compromise sterility and consistency, and often result in inconsistent paste density and prolonged preparation times, making them unsuitable for rapid use in surgical settings.

Innovation Solution

A method involving vacuum expansion and freeze-drying of a paste composition, which reconstitutes spontaneously upon addition of an aqueous medium, eliminating the need for mechanical mixing and reducing preparation time, and a syringe design for storing and delivering the dry paste under vacuum to facilitate quick reconstitution.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If mechanical mixing of powder and liquid is performed to form haemostatic paste, then homogeneous paste can be obtained, but preparation time is prolonged and mechanical effort is increased

Engineering Contradiction:

Improvehomogeneity of pasteVSAvoidpreparation time

Core Design Contradiction:

Stability of the object's compositionVSLoss of time

Solution Approach 1:

The paste is pre-formed and freeze-dried into a porous dry composition before storage. The porous structure is created in advance through freeze-drying, so that upon contact with aqueous medium, the paste reconstitutes spontaneously without requiring mechanical mixing at the time of use. This preliminary preparation of the porous structure eliminates the need for time-consuming mixing during surgical procedures.

Inventive Principle:

Principle #10Preliminary action

2Stability of the object's composition

If intensive mechanical mixing is performed to achieve homogeneous paste, then uniform composition is obtained, but paste density becomes inconsistent and mechanical effort increases

Engineering Contradiction:

Improveuniformity of compositionVSAvoidpaste density consistency

Core Design Contradiction:

Stability of the object's compositionVSManufacturing precision

Solution Approach 1:

The mechanical mixing process is replaced by a spontaneous reconstitution process. The dry porous composition, when contacted with an aqueous medium, automatically reconstitutes into a homogeneous paste through capillary action and diffusion, eliminating the need for mechanical agitation. This substitution ensures consistent paste density without requiring intensive mixing.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Stability of the object's composition

If multiple transfer and mixing steps are performed to prepare paste, then homogeneous composition is achieved, but sterility is compromised and handling time increases

Engineering Contradiction:

Improvehomogeneity of pasteVSAvoidsterility compromise

Core Design Contradiction:

Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The storage container and delivery system are merged into a single integrated unit. The dry porous composition is stored directly in the syringe barrel in a vacuum-sealed state, and upon addition of the aqueous medium through the same syringe, the paste reconstitutes in place. This eliminates multiple transfer steps between containers, maintaining sterility and reducing handling time.

Inventive Principle:

Principle #5Merging (Combining)

4Ease of manufacture

If conventional mixing methods are used to prepare haemostatic paste, then paste can be formed, but preparation complexity and mechanical effort are increased

Engineering Contradiction:

Improvepaste formationVSAvoidoperational simplicity

Core Design Contradiction:

Ease of manufactureVSEase of operation

Solution Approach 1:

The dry porous composition is designed to reconstitute spontaneously upon contact with aqueous medium without requiring external mechanical intervention. The paste formation is a self-service process driven by capillary action and diffusion, eliminating the need for manual mixing operations and simplifying the user procedure.

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

The method allows for rapid, consistent, and sterile reconstitution of a haemostatic paste within seconds, minimizing handling and ensuring optimal consistency and safety in surgical applications.

Implementation Method 1

subjecting the paste to a reduced pressure thereby expanding the paste

Methodology Applied

Scientific EffectVacuum expansion: Vacuum

Implementation Method 2

freezing the expanded paste

Methodology Applied

Scientific EffectFreezing: Freezing

Implementation Method 3

drying the paste

Methodology Applied

Scientific EffectFreeze-drying: Freeze Drying

Data Source

PatentEP3010419B1Vacuum expanded dry composition and syringe for retaining same

Publication Date: 2020.05.20 FERROSAN MEDICAL DEVICES

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AI summary

The present disclosure relates to a method for vacuum expansion of a paste prior to freeze-drying said paste to achieve a dry paste composition which reconstitutes efficiently to form a flowable paste upon addition of an aqueous medium. The present disclosure further relates to a syringe for retaining a dry paste composition in a vacuum.