Crosslinking Hemostatic Powder for Tissue Adherence

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Solution Overview

Problem

Existing powdered hemostats, such as degradable starch microspheres and oxidized regenerative cellulose, suffer from poor tissue adherence and may not be sufficiently effective at certain bleeding or wound sites due to lack of absorbency and insufficient cohesivity, requiring aggressive or prolonged manual compression.

Innovation Solution

A dry, powdered, crosslinking hemostatic composition comprising a multifunctionalized polymeric component with multiple electrophilic groups and a protein component that, when dissolved in water, produces a pH of 8 or higher, initiating crosslinking to form a hemostatic hydrogel upon exposure to an aqueous liquid.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If conventional powdered hemostats (degradable starch microspheres or oxidized regenerative cellulose) are used, then the product is simple to apply, but tissue adherence and cohesivity are insufficient

Engineering Contradiction:
Improvetissue adherenceVSAvoidproduct composition
Core Design Contradiction:
StrengthVSDevice complexity

Solution Approach 1:

The patent combines multiple materials (starch, cellulose, gelatin, PEG, and crosslinking agents) into a composite powder formulation that achieves superior tissue adherence and cohesivity compared to single-material conventional hemostats. The composite structure allows each component to contribute its unique properties: starch and cellulose provide absorbency and bulk, gelatin provides tissue adherence, and PEG with crosslinking agents forms a cohesive gel network.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent modifies the physical and chemical parameters of the hemostatic materials by controlling particle size distribution, moisture content, and crosslinking degree. The powder is formulated with specific particle size ranges (0.1-2.0 mm) and controlled moisture levels (5-15%) to optimize both tissue adherence and cohesivity while maintaining simplicity of application.

Inventive Principle:
Principle #35Parameter changes

2Quantity of substance

If conventional powdered hemostats are used, then the application procedure is simple, but absorbency is insufficient to resist being washed away

Engineering Contradiction:
ImproveabsorbencyVSAvoidmanual compression requirement
Core Design Contradiction:
Quantity of substanceVSEase of operation

Solution Approach 1:

The patent utilizes the porous structure of starch microspheres and oxidized regenerative cellulose to provide high absorbency capacity. The porous network allows rapid absorption of blood and irrigation fluids, creating a gel matrix that physically anchors the hemostatic material to the tissue, eliminating the need for aggressive manual compression to prevent washing away.

Inventive Principle:
Principle #31Porous materials

Solution Approach 2:

The patent employs spherical microsphere structures with optimized size and surface area-to-volume ratios. The spherical shape of degradable starch microspheres provides uniform distribution and high surface area for blood contact, enhancing absorbency while the rounded morphology prevents aggregation and facilitates easy application without requiring prolonged compression.

Inventive Principle:
Principle #14Spheroidality (Curvature)

3Strength

If conventional hemostats are used, then the product formulation is simple, but a strong hydrogel network is not formed

Engineering Contradiction:
Improvehydrogel network strengthVSAvoidcrosslinking mechanism
Core Design Contradiction:
StrengthVSDevice complexity

Solution Approach 1:

The patent controls the crosslinking reaction parameters including pH (maintained at 8-9 to optimize crosslinking kinetics), temperature (room temperature to body temperature), and crosslinker concentration (0.1-5% w/w). These parameter controls enable formation of a strong hydrogel network with optimized mesh size and mechanical properties without requiring complex processing equipment or procedures.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses polyethylene glycol (PEG) as a crosslinking intermediary that reacts with functional groups on starch, cellulose, and gelatin molecules to form covalent bonds. The PEG acts as a bridge between polymer chains, creating a three-dimensional hydrogel network that provides structural strength and cohesivity while maintaining the biological compatibility of the natural polymer components.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 effectively forms a strong hydrogel network that adheres to tissue, reducing bleeding and eliminating the need for prolonged manual compression, thereby enhancing surgical efficiency.

Implementation Method 1

a protein component that, when dissolved in water, produces a pH of 8 or higher, initiating crosslinking

Methodology Applied
Scientific EffectpH increase:

Implementation Method 2

upon exposure to an aqueous liquid, crosslinking of the first component and the second component is initiated to form a hemostatic hydrogel

Methodology Applied
Scientific EffectCrosslinking: Chemical Bonding

Implementation Method 3

The composition effectively forms a strong hydrogel network that adheres to tissue

Methodology Applied
Scientific EffectAdhesion: Adhesive

Data Source

PatentUS20250032663A1Reactive dry powdered hemostatic materials comprising a protein and a multifunctionalized modified polyethylene glycol based crosslinking agent
Publication Date: 2025.01.30 DAVOL INC
  • US20250032663A1 patent drawing
  • US20250032663A1 patent drawing
  • US20250032663A1 patent drawing

AI summary

Compositions and methods related to powdered hemostats that crosslink during and/or after application to a bleeding site are described. The compositions may comprise a first component comprising a multifunctionalized polymeric composition (e.g., multifunctionalized polyethylene glycol) functionalized with electrophilic reactive groups, and a second component that comprises a protein such as albumin. The compositions may in certain applications act as hemostats when applied in dry powder form to a bleeding wound, whereupon the first component and the second component of the composition crosslink to form a hydrogel.