Heparin Binding Substrate for Rapid Hemostasis

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Solution Overview

Problem

Current methods for closing vascular wounds during minimally invasive procedures, such as angiography and angioplasty, are inefficient and pose risks due to reliance on mechanical devices, biologic substances like collagen and thrombin, or prolonged anticoagulation reversal, leading to complications like secondary bleeding and infection risks.

Innovation Solution

A method and apparatus that deheparinize blood by removing negatively charged anticoagulating agents, allowing natural clotting cascades to initiate and complete at the wound site, using a sterile containment chamber with a heparin binding agent and procoagulating agents to activate intrinsic and extrinsic clotting mechanisms.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Speed

If mechanical devices like sutures are used to close vascular wounds, then hemostasis is achieved rapidly, but device complexity increases and technical difficulty rises

Engineering Contradiction:
Improvehemostasis achievement speedVSAvoidclosure device complexity
Core Design Contradiction:
SpeedVSDevice complexity

Solution Approach 1:

The invention extracts and removes heparin (the anticoagulating agent) from the blood using a heparin-binding substrate, thereby eliminating the obstacle to natural clotting without requiring complex mechanical closure devices. This allows rapid hemostasis through biochemical rather than mechanical means.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention enables the blood to clot naturally by removing the anticoagulating agent, allowing the body's own clotting mechanisms to achieve hemostasis without external mechanical intervention. The blood essentially serves itself to clot once the heparin barrier is removed.

Inventive Principle:
Principle #25Self-service

2Reliability

If biologic substances like collagen and thrombin are used to induce clotting, then hemostasis is achieved in anticoagulated blood, but reliability decreases due to potential malfunction and entanglement

Engineering Contradiction:
Improvehemostasis reliabilityVSAvoiddelivery platform complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention converts the presence of heparin-coated blood (which normally prevents clotting) into a benefit by using the heparin-binding substrate to selectively remove heparin, thereby enabling clotting. The harmful anticoagulating agent becomes the target of removal, transforming the problem into the solution.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

Solution Approach 2:

The heparin-binding substrate acts as an intermediary that selectively binds and removes heparin from the blood, mediating between the anticoagulated blood and the natural clotting mechanism. This intermediary enables the transition from anticoagulated to clotting-capable blood without direct contact between opposing forces.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Device complexity

If manual compression is used to achieve hemostasis, then no additional devices are required, but loss of time increases due to prolonged compression requirements

Engineering Contradiction:
Improveclosure device complexityVSAvoidprocedural time
Core Design Contradiction:
Device complexityVSLoss of time

Solution Approach 1:

The invention performs preliminary action by removing heparin from the blood before the clotting process is initiated. This pre-treatment of the blood allows rapid natural clotting to occur subsequently, eliminating the need for prolonged compression time while using no complex devices.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The invention replaces the mechanical compression system with a biochemical system. Instead of applying prolonged mechanical pressure to achieve hemostasis, the heparin-binding substrate chemically removes heparin, allowing the natural biochemical clotting cascade to proceed rapidly without mechanical intervention.

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

4Reliability

If prolonged anticoagulation reversal is waited for, then natural clotting can occur, but loss of time increases and procedural efficiency decreases

Engineering Contradiction:
Improvenatural clotting reliabilityVSAvoidanticoagulation reversal time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The invention performs preliminary removal of heparin from the blood, enabling natural clotting to begin immediately rather than waiting for prolonged anticoagulation reversal. This pre-treatment accelerates the natural process while maintaining its reliability.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The invention changes the parameter of heparin concentration in the blood by selectively removing it through the heparin-binding substrate. This parameter change (from heparin-present to heparin-removed) enables the transition from anticoagulated to clotting-capable blood state rapidly, without prolonged waiting.

Inventive Principle:
Principle #35Parameter changes

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 enables rapid, safe, and reliable hemostasis by utilizing naturally clotted blood to form a solid clot of sufficient strength, reducing procedural time and complications associated with existing methods.

Implementation Method 1

a heparin binding agent, which will bind heparin and remove it from the blood fluid

Methodology Applied
Scientific EffectIon Exchange: Ion Exchange

Implementation Method 2

exposed to a material that has an immobilized substrate that removes a negatively charged anticoagulating agent

Methodology Applied
Scientific EffectAdsorption: Adsorption

Implementation Method 3

initiating the blood's natural clotting cascades and transporting the thus treated blood to the site of the wound where the clotting cascade will be completed producing a clot

Methodology Applied
Scientific EffectCoagulation: Coagulation

Data Source

PatentUS8263223B2Coated surfaces for immobilizing negatively charged anticoagulating agents from blood fluid
Publication Date: 2012.09.11 BIOINTERACTIONS LTD
  • US8263223B2 patent drawing
  • US8263223B2 patent drawing
  • US8263223B2 patent drawing

AI summary

A wound closure apparatus is provided which utilizes blood fluid by activating the clotting cascade of blood fluid outside the body within a substantially enclosed sterile container then introducing, the blood fluid to the wound site to complete clotting. An apparatus for providing ways of inhibiting anticoagulating agents, and slowing fibrin clot degradation are also disclosed. Kits for practicing the invention singularly or in combination with, and/or associated with preferred procedures are also disclosed. The invention provides a clotting cascade initiation apparatus (1) including a substantially enclosed sterile containment chamber within which an aliquot of blood fluid, either autologous or from donor sources can be received, and retained. In preferred embodiments, the sterile containment chamber further includes a heparin binding agent which will bind heparin and remove it from the blood fluid. In further embodiments, the containment chamber will also include a procoagulating agent, wherein a clotting cascade can be initiated when the blood fluid is accepted into the sterile containment chamber.