Flowable Hemostatic Gel for Internal Surgical Bleeding Control

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Solution Overview

Problem

Current methods for inhibiting bleeding at surgical sites, such as suturing, manual pressure, and hemostatic devices, are ineffective for internal incisions, and existing hemostatic gel compounds are difficult to deliver to internal surgical sites.

Innovation Solution

A flowable hemostatic gel composition is formed by mixing a biopolymer solution with a cross-linking agent solution, which rapidly cures in situ to form a solid hydrogel that inhibits bleeding, and can include additional active agents like thrombin to enhance clotting and healing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional hemostatic methods (suturing, manual pressure, absorbent materials) are used, then bleeding can be controlled in accessible areas, but they are ineffective for internal incisions that are not easily accessible

Engineering Contradiction:
Improvehemostatic effectivenessVSAvoidaccessibility to surgical site
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent employs a flowable gel composition that can be delivered through catheters or injection devices to internal surgical sites, utilizing fluid dynamics to transport the hemostatic agent to inaccessible locations where traditional mechanical methods cannot reach

Inventive Principle:
Principle #29Pneumatics and hydraulics

Solution Approach 2:

The gel composition undergoes a phase transition from flowable (injectable) to solid (hemostatic) state after delivery, changing its physical parameters in situ to provide effective bleeding control at the target location while maintaining ease of delivery

Inventive Principle:
Principle #35Parameter changes

2Reliability

If existing hemostatic gel compounds are applied to surgical sites, then bleeding inhibition is achieved, but delivery to internal surgical sites is limited

Engineering Contradiction:
Improvebleeding inhibitionVSAvoiddeliverability to internal site
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The gel composition is formulated to be flowable during delivery and then transitions to a solid state at the target site, dynamically changing its rheological properties to first enable easy delivery through catheters and then provide stable hemostatic function at the internal surgical site

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent uses a delivery system (catheter or injection device) as an intermediary to transport the flowable gel composition to internal surgical sites that are not directly accessible, enabling indirect delivery of the hemostatic agent to the target location

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If solid hemostatic materials are applied to surgical sites, then bleeding is controlled, but secondary removal is required

Engineering Contradiction:
Improvehemostatic controlVSAvoidremoval procedure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The gel composition is designed to biodegrade into harmless byproducts after fulfilling its hemostatic function, allowing the body to naturally metabolize and eliminate the material without requiring surgical removal or intervention, thus simplifying the post-treatment process

Inventive Principle:
Principle #34Discarding and recovering

Solution Approach 2:

The hemostatic gel provides self-limiting action by forming a stable clot that stops bleeding, then naturally degrades over time without requiring external intervention for removal, allowing the material to service itself through biological degradation pathways

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 gel composition effectively inhibits bleeding at surgical sites, including internal incisions, by forming a solid hydrogel that safely biodegrades, eliminating the need for secondary removal and providing a controlled release of active agents to facilitate healing.

Implementation Method 1

The cross-linking agent links chains of the biopolymer together to form a solid hydrogel

Methodology Applied
Scientific EffectCross-linking: Chemical Bonding

Implementation Method 2

a flowable gel solution comprising a biopolymer dissolved in a first solvent

Methodology Applied
Scientific EffectSolvation: Solvation

Data Source

PatentUS10751444B2Flowable hemostatic gel composition and its methods of use
Publication Date: 2020.08.25 PHILLIPS MEDICAL LLC
  • US10751444B2 patent drawing
  • US10751444B2 patent drawing
  • US10751444B2 patent drawing

AI summary

A method of inhibiting bleeding from an open surgical site includes mixing (i) a flowable gel solution comprising a biopolymer dissolved in a first solvent and (ii) a flowable hardener solution comprising a cross-linking agent dissolved in a second solvent to form a flowable hemostatic gel composition. The method also includes applying the flowable hemostatic gel composition to the open surgical site. The cross-linking agent links chains of the biopolymer together to form a solid hydrogel that inhibits bleeding from the surgical site.