Flowable Haemostatic Composition for Faster Surgical Preparation
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Solution Overview
Problem
Current haemostatic products are inefficient in controlling severe bleedings and impractical for minimally invasive surgical procedures, requiring extensive mixing and handling, which can compromise sterility and increase preparation time.
Innovation Solution
A haemostatic composition comprising biocompatible polymers, fibrinogen, and thrombin, which remains flowable for over 1.5 hours after reconstitution, allowing pre-preparation and extended use, with a simplified mixing process that minimizes handling and ensures sterility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If thrombin and fibrinogen are provided separately or in dry form to prevent premature action, then stability is improved, but device complexity and ease of operation worsen due to requiring separate application or mixing with aqueous medium
Solution Approach 1:
The patent combines thrombin and fibrinogen into a single dry mixture with biocompatible polymer particles. This merging allows all components to be stored together stably in dry form while simplifying application - the user only needs to add aqueous medium and stir, eliminating the complexity of separate application or reconstitution steps.
Solution Approach 2:
The thrombin and fibrinogen are pre-mixed in dry form with the biocompatible polymer particles before use. This preliminary mixing in stable dry form allows the components to be prepared in advance and stored, then quickly reconstituted by adding aqueous medium when needed, improving both stability and ease of operation.
2Stability of the object's composition
If extensive mixing such as kneading or transfer between syringes is performed to achieve uniformity, then homogeneity is improved, but loss of time increases due to extended preparation time
Solution Approach 1:
The patent replaces extensive mechanical mixing operations (kneading, transfer between syringes) with simple stirring after adding aqueous medium to the dry mixture. The dry pre-mixed formulation ensures uniform distribution of thrombin and fibrinogen with the polymer particles, so that minimal mechanical action is needed to achieve homogeneity, dramatically reducing preparation time.
3Ease of operation
If thrombin and fibrinogen are mixed with aqueous medium upon application, then ease of operation is improved, but reliability worsens due to risk of premature action during handling
Solution Approach 1:
The patent changes the physical state parameter from wet to dry for the mixture of thrombin, fibrinogen, and biocompatible polymer particles. In dry form, the components are stable and can be handled without premature thrombin-fibrinogen interaction. The dry mixture is reconstituted with aqueous medium immediately before application, ensuring reliability while maintaining ease of operation.
4Reliability
If haemostatic products are applied as sponges, patches, glues or sealants, then effectiveness for mild and moderate bleedings is achieved, but adaptability worsens for minimally invasive surgical procedures where these forms are impractical
Solution Approach 1:
The patent creates a universal dry mixture formulation that can be adapted to multiple application forms and surgical procedures. The mixture of biocompatible polymer particles with thrombin and fibrinogen can be reconstituted as needed and applied in various forms including sprays, gels, or direct application, making it suitable for both traditional surgeries and minimally invasive procedures where sponges, patches, glues, and sealants are impractical.
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 composition provides faster and more efficient haemostasis, reducing preparation time and minimizing errors, while being suitable for minimally invasive surgeries and maintaining consistency and adhesive properties.
Implementation Method 1
Thrombin is a well-known haemostatic adjuvant in haemostatic compositions, which acts as a serine protease that converts soluble fibrinogen into insoluble strands of fibrin
Implementation Method 2
a) one or more biocompatible polymers in particulate form
Data Source
AI summary
The present disclosure relates to haemostatic compositions comprising a biocompatible polymer, thrombin and fibrinogen and methods for the preparation of such compositions.