Hemostatic Sheet with Reactive Groups for Severe Bleeding

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Solution Overview

Problem

Current hemostatic products are limited in their ability to effectively control severe bleeding, particularly in irregular tissue surfaces and cavities, due to lack of flexibility and homogeneity, leading to prolonged bleeding and increased resource utilization during surgical procedures.

Innovation Solution

A biocompatible, flexible hemostatic sheet with a carrier structure and reactive polymer particles that react with amine groups in tissue and blood, providing rapid hemostasis by forming covalent bonds and sealing the wound site.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If patches are used for severe bleeding, then hemostasis can be achieved, but they lack flexibility and homogeneity to conform to irregular tissue surfaces and cavities

Engineering Contradiction:
Improvehemostasis effectivenessVSAvoidflexibility to conform to irregular surfaces
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The hemostatic composition is provided in a flowable state during application, allowing it to dynamically adapt and conform to irregular tissue surfaces and cavities. After application, the composition transitions from flowable to a solidified state, providing structural stability while maintaining the adapted shape. This dynamic state change resolves the contradiction between initial flexibility for adaptation and final stability for hemostasis.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The invention changes the physical parameters of the hemostatic composition from flowable (low viscosity) to solidified (high viscosity) through controlled transformation. This parameter change allows the material to first flow and conform to irregular surfaces, then solidify to provide stable hemostatic action, simultaneously achieving adaptability and reliability.

Inventive Principle:
Principle #35Parameter changes

2Adaptability or versatility

If flowable hemostatic agents are used for cavity bleeding, then they can be applied, but additional dosages are required that reduce efficacy and increase time to control bleeding

Engineering Contradiction:
Improveapplicability to cavity bleedingVSAvoidtime to control active bleeding
Core Design Contradiction:
Adaptability or versatilityVSLoss of time

Solution Approach 1:

The hemostatic composition undergoes a phase transition from flowable to solidified state after application. This phase transition allows a single application to achieve both cavity filling (requiring flowability) and effective hemostasis (requiring structural integrity). The solidification prevents the need for additional dosages, reducing both time and resource consumption while maintaining efficacy.

Inventive Principle:
Principle #36Phase transitions

3Ease of operation

If standard hemostatic methods are used, then temporary control can be achieved, but they fail to provide rapid and efficient hemostasis in severe bleeding cases

Engineering Contradiction:
Improvesimplicity of hemostatic techniqueVSAvoidspeed of hemostasis achievement
Core Design Contradiction:
Ease of operationVSProductivity

Solution Approach 1:

The invention replaces complex mechanical hemostatic methods (such as suturing, clamping, or layered packing) with a single application of the hemostatic composition. The composition's ability to flow into irregular spaces and then solidify provides mechanical hemostatic effect without requiring complex mechanical manipulation, simultaneously improving ease of operation and speed of hemostasis.

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

4Reliability

If multiple dosages of flowable agents are applied, then complete hemostasis can be achieved, but efficacy is reduced and costs increase

Engineering Contradiction:
Improvecomplete hemostasisVSAvoidamount of hemostatic agent required
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The phase transition from flowable to solidified state enables a single dosage to achieve complete hemostasis. The solidified matrix provides structural stability and sustained hemostatic action, eliminating the need for multiple dosages. This reduces both the quantity of substance required and the associated costs while maintaining complete hemostatic effectiveness.

Inventive Principle:
Principle #36Phase transitions

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 hemostatic sheet achieves hemostasis within minutes, significantly reducing bleeding time and resource use, and is effective in both open and minimally invasive surgical procedures, outperforming comparative devices in clinical and preclinical studies.

Implementation Method 1

reactive electrophilic groups capable of reacting with amine groups in tissue and blood

Methodology Applied
Scientific EffectCovalent bonding: Chemical Bonding

Implementation Method 2

nucleophilic polymer carrying reactive nucleophilic groups, and an electrophilic polymer carrying at least three reactive electrophilic groups capable of reacting with the nucleophilic polymer

Methodology Applied
Scientific EffectChemical reaction between nucleophilic and electrophilic groups: Chemical Bonding

Data Source

PatentUS20240261462A1System and methods for using tissue-adhesive porous hemostatic products with severe surface and cavity bleeding
Publication Date: 2024.08.08 CILAG GMBH INTERNATIONAL
  • US20240261462A1 patent drawing
  • US20240261462A1 patent drawing
  • US20240261462A1 patent drawing

AI summary

Methods and systems for using a biocompatible and flexible hemostatic sheet comprising a fibrous carrier structure, and reactive electrophilic groups capable of reacting with amine groups in tissue and blood, the hemostatic sheet delivered to the tissue at the bleeding site of an organ to restore hemostasis during an open surgery procedure.