Local Factor VII Administration for Hemorrhage Control

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Solution Overview

Problem

Current treatments for clinically significant local hemorrhage, such as postpartum hemorrhage or hemorrhage due to surgery, often fail to adequately arrest bleeding, especially when caused by a combination of local lesions and systemic deficiencies or diseases, leading to inadequate hemostasis and the need for radical surgical intervention.

Innovation Solution

The local administration of purified or concentrated human Factor VII or its biologically active derivatives to the bleeding site, either through intrauterine instillation, uterine lavage, or direct application using various forms like gels, sprays, or swabs, to promote hemostasis and reduce systemic side effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If systemic administration of blood coagulation factors is used to treat local bleeding, then hemostatic effect is achieved, but thrombotic complications and unwanted side effects occur

Engineering Contradiction:
Improvehemostatic effectVSAvoidthrombotic complications
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent divides the treatment approach into localized application at the bleeding site rather than systemic administration. Factor VIIa is applied topically or locally to the specific hemorrhage location, segmenting the therapeutic effect to only where needed, thereby achieving hemostasis without systemic thrombotic risks

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention applies hemostatic agents locally to the bleeding site with concentrated effect where needed. By using topical application, intrauterine instillation, or local injection methods, the factor VIIa achieves high local concentration at the hemorrhage site while maintaining low or absent systemic levels, resolving the contradiction between effective hemostasis and thrombotic side effects

Inventive Principle:
Principle #3Local quality

2Reliability

If systemic administration of antifibrinolytic agents is used to treat bleeding, then clot dissolution is inhibited, but the effect is inadequate when hemostatic mechanisms are deficient

Engineering Contradiction:
Improvebleeding controlVSAvoideffectiveness in deficient hemostatic mechanisms
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent applies hemostatic factors directly to the bleeding site before the clot formation process can fail. By providing exogenous factor VIIa locally at the hemorrhage site, the coagulation cascade is initiated and completed locally, ensuring adequate clot formation even when systemic hemostatic mechanisms are deficient

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The invention uses factor VIIa as a mediator to bridge the gap in deficient hemostatic mechanisms. Factor VIIa directly activates factor X and initiates the coagulation cascade locally at the bleeding site, serving as an intermediary that bypasses other potentially deficient coagulation factors and directly restores clotting function where needed

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If radical surgical intervention is performed to arrest bleeding, then hemostasis is achieved, but patient trauma and recovery time increase

Engineering Contradiction:
ImprovehemostasisVSAvoidsurgical trauma
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replicates the natural hemostatic process by applying concentrated coagulation factors locally at the bleeding site. This artificial replication of the body's own clotting mechanism achieves hemostasis without the need for radical surgical intervention, thereby reducing surgical trauma while maintaining effective bleeding control

Inventive Principle:
Principle #26Copying

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 approach effectively reduces blood loss and avoids thrombotic complications associated with systemic administration of coagulation factors, providing a rapid and effective means to arrest bleeding in acute, recurrent, or chronic hemorrhages, thereby minimizing the need for more invasive procedures.

Implementation Method 1

activated blood coagulation factors, i.e. hemostatic agents, are administered directly to the bleeding site

Methodology Applied
Scientific EffectCoagulation: Coagulation

Data Source

PatentUS8461115B2Methods for local treatment with factor VII
Publication Date: 2013.06.11 STELLARIS PHARMA

AI summary

The present invention provides methods for the local treatment of bleeding in a subject and/or reducing unwanted effects associated with the systemic administration of thrombotic agents to a subject, by local administration of FVII to the subject.