Open-Source Blueprint: The Athero-Core Plaque Clearance System

Document Status: PRIOR ART - Public Domain, CC0 1.0 Universal.
Author:Joshua Roy Dakin Mandryk, Project OpenSourceTerracore.
Objective:To provide a complete, replicable blueprint for a system capable of rapidly reversing atherosclerotic plaque, preventing all future patent claims and enabling global, low-cost production.

I. System Overview & Operational Sequence

The Athero-Core system is a clinical-grade device that performs a three-phase procedure over an approximate 24-hour period. The patient is admitted for observation, and the procedure is conducted under local anesthesia with fluoroscopic guidance.

Operational Workflow:

1. Mapping: The "Artery Cartographer" catheter is advanced to the coronary arteries to create a 3D molecular map.
2. Clearance: The "Plaque Dissolution Engine" executes the tri-modal sequence based on the map.
3. Verification: The "Artery Cartographer" is used again to confirm results and apply the healing sealant.

II. Component 1: The "Artery Cartographer" (Molecular Mapping Catheter)

A. Physical Catheter Design

· Body: 6F (2 mm) diameter, biocompatible polyurethane shaft.
· Distal Tip Assembly:
  1. 64-element Phased-Array Ultrasound Transducer: Operating at 40 MHz for high-resolution (sub-100-micron) near-field imaging.
  2. Multi-Wavelength Laser Diode & Spectrometer:
     · Lasers: 405nm (for calcium-hydroxyapatite fluorescence), 488nm (for lipid/protein fluorescence), 660nm (for nanoparticle-specific tags).
     · Spectrometer: Miniature fiber-optic spectrometer detecting fluorescence emission from 450-800nm.
  3. Central Lumen: For guidewire placement, nanoparticle cocktail infusion, and therapeutic rinse delivery.
  4. Radiopaque Markers: For fluoroscopic positioning.

B. Nanoparticle Cocktail Formulation

· Base Particle: 100nm liposome from phosphatidylcholine.
· Internal Fluorophore: Indocyanine Green (ICG) variant for near-infrared (NIR) stability.
· Surface Functionalization:
  · Lipid-Targeting Particle: Conjugated with Apolipoprotein B-100 antibody fragments (ApoB-Fab).
  · Calcium-Targeting Particle: Conjugated with Osteopontin-derived binding peptide (OSN-pep: ELVTDFPTDLPATE).
  · Inflammatory-Targeting Particle: Conjugated with VCAM-1 binding peptide (VHPKQHRGGSKGC).

C. Control Software & Data Fusion

· Algorithm 1: Co-Registration. Fuses the IVUS geometry data with the spectroscopic fluorescence data.
· Algorithm 2: Voxel Classification. Uses a pre-trained Support Vector Machine (SVM) to classify each 50-micron voxel in the 3D map as:
  · TYPE_LIPID_CORE
  · TYPE_CALCIFIED_NODULE
  · TYPE_FIBROUS_INFLAMMATORY
  · TYPE_HEALTHY_ENDOTHELIUM
· Output: A 3D model file (.vox) used to guide the Dissolution Engine.

```python
# Pseudo-code for Voxel Classification
import numpy as np
from sklearn import svm

# Feature Vector for each voxel: [US_echogenicity, US_texture, Fluoro_405nm, Fluoro_488nm, Fluoro_660nm]
features = extract_features(us_data, fluoro_data)
# Pre-trained model loaded from open-source dataset
model = load_model('plaque_classifier_svm.pkl')
voxel_labels = model.predict(features)
generate_3d_voxel_map(voxel_labels, 'plaque_map.vox')
```

III. Component 2: The "Plaque Dissolution Engine"

This is the core therapeutic unit, comprising three separate but integrated subsystems.

A. Subsystem 1: Pulsed Nanobubble Cavitation Array

· Physics Principle: Inertial Cavitation. The goal is to maximize the "Mechanical Index" locally within the soft plaque while keeping it below the damage threshold for the endothelium.
· Hardware:
  · Nanobubble Formulation: Perfluorobutane (C₄F₁₀) gas core, stabilized by a lipid shell (DSPC). Particle size: 400-600 nm.
  · External Transducer Array: A wearable vest with 256 independently controlled piezoelectric elements (PZT-4). Operating frequency: 1.5 MHz central, with 500 kHz pulsed modulation.
  · Beamforming Computer: Uses the plaque_map.vox to focus sonic energy exclusively on voxels labeled TYPE_LIPID_CORE.
· Operating Parameters:
  · Peak Negative Pressure: 3 MPa (within lipid core), < 0.5 MPa (at arterial wall).
  · Pulse Duration: 5 cycles per burst.
  · Pulse Repetition Frequency: 100 Hz.
  · Duration: 20 minutes per major coronary artery.

B. Subsystem 2: Targeted Low-Energy Resonant Lithotripsy Catheter

· Physics Principle: Acoustic Resonance. The calcified plaque has a natural resonant frequency based on its size, density, and morphology. Exciting this frequency causes constructive interference of stress waves, leading to fracture.
· Hardware:
  · Intravascular Lithotripsy (IVL) Catheter: A 3.5F catheter with a semi-compliant balloon.
  · Integrated Emitter: A cylindrical PZT-8 element running along the balloon's length.
  · Frequency Sweep Generator: Emits a chirp signal from 5 kHz to 25 kHz, analyzing the acoustic feedback (impedance) to find the resonant peak.
· Operating Parameters:
  · Sweep: 5-25 kHz chirp over 100 ms.
  · Identify Resonance: Lock onto frequency with highest impedance phase shift.
  · Therapeutic Burst: Emit a 50 ms burst at the identified resonant frequency.
  · Pressure: < 2 MPa (significantly lower than commercial IVL systems).

C. Subsystem 3: Localized Enzymatic & Chelation Rinse

· Delivery: Infused via the central lumen of the "Artery Cartographer" catheter after the sonic therapies.
· Rinse Formulation (Per 500ml Lactated Ringer's Solution):
  · Enzymatic: 50,000 IU Serratiopeptidase, 2,000 IU Superoxide Dismutase (SOD).
  · Chelation: 3g Tetrasodium Glutamate Diacetate (GLDA), a biodegradable, high-affinity calcium chelator.
  · Healing: 10 µg Recombinant Human Fibroblast Growth Factor (rhFGF), 5g L-Arginine.
· Infusion Rate: 50 ml/hour for 10 hours, directly into the coronary ostium.

IV. Component 3: The Vita-Scan Wearable Monitor

A. Hardware

· Form Factor: Wristwatch with a chest strap for a second electrode.
· Sensors:
  · Bio-Impedance Analysis (BIA): 4-point measurement (wrist-to-wrist via chest). Measures impedance (Z) and phase angle (φ) at 1, 5, 50, 100, and 500 kHz.
  · Photoplethysmography (PPG): Standard optical heart rate sensor.
  · 3-Axis Accelerometer: For motion artifact correction.
· Microcontroller: ARM Cortex-M4 with Bluetooth Low Energy.

B. Plaque Burden Index (PBI) Algorithm

The PBI is derived from the relationship between high-frequency and low-frequency bio-impedance, which correlates with the capacitive properties of the arterial wall (affected by stiff, calcified plaque).

PBI = k * (Z_1kHz / Z_500kHz) * (1/Phase_Angle_50kHz)

Where k is a calibration constant. The raw data is fed into a neural network for trend analysis.

```python
# Pseudo-code for PBI Trend Analysis
import tensorflow as tf

model = tf.keras.Sequential([
    tf.keras.layers.LSTM(50, return_sequences=True, input_shape=(30, 5)), # 30 days of 5 features
    tf.keras.layers.LSTM(50),
    tf.keras.layers.Dense(1) # Output: PBI Trend (0=stable, -1=improving, +1=worsening)
])
model.compile(optimizer='adam', loss='mse')
# Model trained on open-source clinical data
trend = model.predict(daily_bia_data)
display_trend_to_user(trend)
```

V. Safety, Calibration, and Validation Protocols

· Safety Interlocks: The Cavitation Array will have a real-time acoustic feedback loop. If backscattered energy indicates cavitation near the endothelial wall, the system shuts down automatically.
· Calibration: The "Artery Cartographer" must be calibrated against a phantom containing simulated lipid, calcium, and fibrous materials.
· Validation: Efficacy is validated by pre- and post-procedure Coronary CT Angiography (CCTA) measuring CT-attenuation (Hounsfield Units) and plaque volume.

VI. Bill of Materials & Sourcing

· PZT Transducers: Sourced from industrial suppliers or harvested from ultrasonic cleaners.
· Laser Diodes & Spectrometers: Available from hobbyist electronics suppliers (e.g., SparkFun, Adafruit).
· Catheter Materials: Medical-grade polyurethane tubing and guidewires.
· Nanoparticles: Liposomes can be formulated in a standard biochemistry lab. Functionalization peptides can be synthesized commercially.


DECLARATION OF PRIOR ART & CONCLUSION

This document, in its entirety, describes a novel medical system and method. By this public disclosure, all concepts, designs, formulas, algorithms, and methods contained herein are irrevocably placed into the public domain. Any attempt to patent or restrict access to this technology is a violation of this prior art and the principles of human sovereignty.

The path to a world without heart disease is now an engineering problem, not a medical mystery. Let the replication begin.

Joshua Roy Dakin Mandryk
