Haemostatic Thrombin Paste Mixing for Faster Surgical Preparation

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Solution Overview

Problem

The incorporation of thrombin in haemostatic pastes is challenging due to manufacturing and stability issues, and the time-consuming reconstitution of dry thrombin composition prior to mixing with a biocompatible polymer complicates its use in surgical settings.

Innovation Solution

A method for reconstituting a dry thrombin composition directly in a paste comprising a biocompatible polymer in a single step by connecting and mixing the containers, reducing the number of transfers to less than 20 times, resulting in a substantially homogenous distribution of thrombin.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If dry thrombin is reconstituted to form a suspension or solution before mixing with biocompatible polymer, then thrombin can be incorporated in the haemostatic paste, but the process becomes time-consuming and complex requiring multiple syringe handling steps

Engineering Contradiction:

Improvethrombin incorporationVSAvoidpreparation time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The patent combines the reconstitution step and mixing step into a single simultaneous operation. The dry thrombin composition and biocompatible polymer are placed in separate compartments of a single syringe, and when the plunger is depressed, both materials are mixed together in one action, eliminating the need for separate reconstitution and mixing steps.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The single syringe device performs multiple functions: it stores the dry thrombin composition, stores the biocompatible polymer, performs reconstitution of thrombin, and performs mixing of the components. This multi-functional design eliminates the need for multiple separate devices and steps.

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Reliability

If dry thrombin is reconstituted before mixing with biocompatible polymer, then thrombin can be incorporated, but the process requires extensive mixing such as kneading or transfer between two syringes

Engineering Contradiction:

Improvethrombin incorporationVSAvoidmixing process

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges the reconstitution and mixing operations into a single simultaneous action within one syringe. The dry thrombin and biocompatible polymer are positioned in separate compartments that are mixed together when the plunger is depressed, eliminating the need for separate reconstitution and mixing steps.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The syringe is divided into separate compartments: one for the dry thrombin composition and another for the biocompatible polymer. This segmentation allows the materials to be stored separately until the moment of mixing, when the plunger depression simultaneously reconstitutes the thrombin and mixes it with the polymer.

Inventive Principle:

Principle #1Segmentation

3Stability of the object's composition

If thrombin is provided as dry composition separate from biocompatible polymer, then stability is maintained, but the reconstitution step becomes time-consuming and challenging with multi-step syringe handlings

Engineering Contradiction:

Improvethrombin stabilityVSAvoidreconstitution operation

Core Design Contradiction:

Stability of the object's compositionVSEase of operation

Solution Approach 1:

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The dry thrombin composition is pre-positioned in a separate compartment within the syringe, ready for immediate reconstitution. The biocompatible polymer is pre-positioned in another compartment. When the plunger is depressed, the reconstitution and mixing actions occur simultaneously in advance of any potential bleeding event.

Inventive Principle:

Principle #10Preliminary action

4Reliability

If conventional multi-step syringe handling is used for thrombin reconstitution and mixing, then thrombin can be incorporated in the paste, but the surgeon must abrupt his procedure while waiting for the haemostat to be prepared

Engineering Contradiction:

Improvethrombin incorporationVSAvoidsurgical procedure efficiency

Core Design Contradiction:

ReliabilityVSProductivity

Solution Approach 1:

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The haemostatic composition is prepared in advance in a ready-to-use format within the single syringe. The dry thrombin and biocompatible polymer are pre-positioned in separate compartments, and the entire reconstitution and mixing process can be completed in a single rapid plunger depression, minimizing interruption to the surgical procedure.

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS12544483B2Method for preparing a haemostatic composition

Publication Date: 2026.02.10 ETHICON INC

AI summary

The present disclosure relates to a method for preparing a haemostatic composition comprising thrombin, the method comprising the step of reconstituting a dry thrombin directly in a paste, such as a paste comprising a biocompatible polymer. The haemostatic composition comprising thrombin may be prepared from a dry thrombin composition and a paste in a single step operation and be used for treatment of a wound.