BIOMEDICAL INSTRUMENTATION
1. Medical devices
- Defs:
o JAMA: “Medical devices used to diagnose, prevent or treat medical conditions
without any chemical effect.”
o FDA: “Medical devices range from simple tongue depressors and bedpans to
complex programmable pacemakers with microchip technology and laser
surgical devices.”
o EMA: “Medical devices are products or equipment intended generally for a
medical use and are regulated at Member State level.”
- European Medicines Agency (EMA): evaluates the quality, safety and efficacy of
marketing authorization applications.
- Regulatory environment: Risk to the patient determines the amount of testing
required for approval. 3 classes:
o Class I: Low-risk devices. (oxygen masks, hospital beds, wheelchairs, bandages,
tongue depressors, and handheld surgical instruments)
o Class II: Intermediate risk devices. (absorbable sutures, blood transfusion kits,
catheters, CT scanners, blood pressure cuffs, pregnancy test kits, and infusion
pumps)
o Class III: High-risk devices. (Deep brain simulators, defibrillators, cochlear
implants, breast implants, high-frequency ventilators, implanted prosthetics,
and pacemakers)
- Ten most important biomedical devices
1. X-ray machine
2. CT
3. MRI
4. Heart-lung machines: oxygenates and pumps the blood in open heart
operations
5. Artificial kidney
6. Electrosurgical unit: makes tissue cutting easier and cauterizes tissue
7. Cardiac pacemaker: simulates dysfunctional heart
8. Pulse oximeter: noninvasively measures tissue oxygen saturation of
anesthetized patients
9. Ventilator
10. Artificial hips, knees or other joints
- Image guided surgery
o We can map the pre-surgery image with the procedure in real time
o Intraoperative electron radiation therapy (IOERT): selective irradiation during
cancer surgery. In Gregorio Marañon’s Hospital
2. Biomedical Microdevices (BioMEMS)
BioMEMS: biomedical Micro Electro Mechanical Systems -> 100nm-2µm
Def: Devices or systems, constructed using techniques from micro/nano-scale fabrication, that
are used for processing, delivery, manipulation, analysis, or construction of biological and
chemical entities.
MEMS enable integration of different functionalities (electrical, mechanical, optical,
computation, communication) into a single chip with batch fabrication
Applications:
a. Diagnosis
- Genomic and proteomic microarrays: ordered collection of microspots each containing
a single defined molecular species that interacts with the analyte to test thousands of
parameters in a single experiment.
o cDNA microarray: microarray for gens detection
- PCR (Polymerase chain reaction):
o PCR (no BioMEMS): amplification of DNA sequences. Process: thermal cycling of
DNA sequence and DNA polymerase -> consumes lot of time (hours) and
expensive reagents
o PCR chips (BioMEMS): miniaturize the reaction environment.
▪ Shorter thermal cycling time (faster) and lower amount of reactants
(cheapper)
b. Biosensors
Def: consist of a biological recognition system (bioreceptor) and a transducer. Interaction of
bioreceptor with analyte causes an effect that the transducer converts into a measurement
(electrical signal).
Advantages:
- Less power consumption
- Less implantation trauma
- Less transport time for chemical analytes
- Turns into less sensor’s response time
Types:
- Micromechanical sensors
- Electrical and electrochemical
sensors
- Optical sensors
ELISA (enzyme-linked immunosorbent assay) -> example of BioMEMS sensor
- Plate-based testing technique which detects and quantifies biomolecules like peptides,
proteins, antibodies, and hormones
3. Nanoparticles
Nanotechnology: is a field of research and innovation concerned with building, materials and
devices on the scale of atoms and molecules.
At Nanoscale (1nm-150nm) materials show size-dependent properties
In this case: colour depends on size
Nanoscale:
Characteristics of a nanoparticle:
- Size
- Material
- Shape
- Surface
o Coating (revestimiento) -> PEGylation
o Functional group
o Charge
o Targeting ligand
Applications:
- Imaging -> Au NPs (MRI), CdS NPs (NM), Fe3O4 (X-ray)
- Drug Delivery