Stent Selection via Platelet Coagulability Thresholds

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Solution Overview

Problem

Current methods lack a reliable way to predict which patients are at greatest risk for developing restenosis after stent implantation, leading to unnecessary use of costly drug-eluting stents and prolonged antiplatelet therapy, with no validated markers to guide the intensity of antiproliferative therapy.

Innovation Solution

Assessing the risk of restenosis by measuring the maximum tensile strength of blood clots using thrombelastography, which correlates with the speed and intensity of thrombin generation, allowing for personalized stent selection and drug delivery based on individual risk profiles.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If drug-eluting stents are implanted in the majority of patients, then restenosis rates are reduced, but costs increase and thrombosis risk increases

Engineering Contradiction:
Improverestenosis preventionVSAvoidthrombosis risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies parameter changes by measuring platelet reactivity parameters (aggregation response, P-selectin expression, thromboxane B2 levels) to identify patients with abnormal platelet function. Based on these parameter assessments, the intensity of antiproliferative therapy is tailored - high-risk patients receive drug-eluting stents with aggressive therapy, while low-risk patients receive bare metal stents with standard therapy, optimizing the balance between restenosis prevention and thrombosis risk

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent implements local quality by differentiating treatment approaches based on individual patient characteristics. Rather than uniform application of drug-eluting stents to all patients, the treatment intensity is localized to match each patient's specific restenosis risk profile determined by platelet reactivity assessment, ensuring appropriate therapy delivery to those who need it most

Inventive Principle:
Principle #3Local quality

2Reliability

If drug-eluting stents are used in all patients, then restenosis is reduced, but treatment costs increase

Engineering Contradiction:
Improverestenosis preventionVSAvoidtreatment cost
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The patent applies partial action by providing antiproliferative therapy at varying intensities based on patient risk stratification. High-risk patients receive full-intensity drug-eluting stent therapy, while low-risk patients receive standard bare metal stent therapy with less aggressive medication, avoiding excessive treatment in patients who would not benefit from it

Inventive Principle:
Principle #16Partial or excessive action

Solution Approach 2:

The patent uses parameter-based risk assessment (platelet aggregation, P-selectin, thromboxane B2 levels) to determine treatment intensity. This parameter-driven approach enables cost-effective allocation of expensive drug-eluting stents to patients with abnormal platelet reactivity parameters while using cost-effective bare metal stents for patients with normal parameters

Inventive Principle:
Principle #35Parameter changes

3Adaptability or versatility

If platelet reactivity is measured to identify high-risk patients, then treatment can be personalized, but measurement complexity increases

Engineering Contradiction:
Improvepersonalized treatmentVSAvoidmeasurement complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent segments the complex assessment into distinct, measurable components: platelet aggregation response to ADP, P-selectin expression levels, and thromboxane B2 concentrations. Each component can be measured separately using established laboratory techniques, making the overall assessment manageable and clinically feasible

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent uses measurable biomarkers (P-selectin, thromboxane B2, aggregation response) as intermediaries to assess platelet reactivity. These intermediary measurements provide objective, quantifiable data that reflect underlying platelet function without requiring direct observation of complex biological processes, simplifying the assessment

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

This approach enables accurate risk stratification for restenosis, reducing the use of costly drug-eluting stents in low-risk patients and tailoring antiproliferative therapy, thereby minimizing complications and costs while optimizing treatment efficacy.

Implementation Method 1

measuring the maximum tensile strength of blood clots using thrombelastography, which correlates with the speed and intensity of thrombin generation

Methodology Applied
Scientific EffectThrombin generation:

Implementation Method 2

measuring the maximum tensile strength of blood clots using thrombelastography

Methodology Applied
Scientific EffectCoagulation: Coagulation

Data Source

PatentUS10139421B2Detection of restensosis risk in patients receiving a stent
Publication Date: 2018.11.27 GURBEL PAUL A
  • US10139421B2 patent drawing
  • US10139421B2 patent drawing
  • US10139421B2 patent drawing

AI summary

Provided is a method of selecting a stent for implantation in the circulatory system of a human being. The method comprises obtaining a blood sample from a patient who requires implantation of a stent and testing said blood sample to determine a platelet coagulability level. The determined platelet coagulability level of said blood sample is compared with a threshold level of blood platelet coagulability. A determined platelet coagulability level above said threshold level indicates that a risk of restenosis is relatively high. If the determined platelet coagulability level is below said threshold level, a bare metal stent is selected. If the determined platelet coagulability level is at or above said threshold level, a drug-eluting stent is selected.