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Seminar on MEMS in
Medicine
Synopsis
Picture of a 350 micron high microneedle, with a base of 250 microns, the flow
channel is 70 microns in its widest direction.
OBJECTIVES
INTRODUCTION
WHAT IS BioMEMS?
ADVANTAGES
Lower cost
Owing to the batch-mode manufacturing techniques borrowed from the integrated
circuit industry, small size die, and consequently large volumes and lower cost have
become possible. [2]
Reliability
Silicon is an almost perfectly elastic material. It also doesn’t erode (wear out). Micro-
machines last much longer than their macro counterparts.
Higher performance
Arrayed sensors can provide simultaneous sensing of multiple modalities (pressure,
temperature, chemical reactions ... etc.), or for increased dynamic range, or for
microscopic scale spatial discrimination of signals [2]
Real-time feedback
MEMS technology provides the real-time feedback surgeons that can improve surgical
outcomes, lower risk, and help control costs by providing the surgeon with real-time
data about instrument force, performance, tissue density, temperature, or chemistry, as
well as provide better and faster methods of tissue/fluid preparation, cutting, and
extraction. [4]
Versatility
The devices can be activated in several different ways. It can be activated by remote
control, giving control to the doctor or the patient. It can be activated on a set time
basis. Some devices are even automatically triggered by sensors built into the device
that detect when the drug needs to be administered. [3]
Tissue Sensing
The ability to distinguish between different types of tissue in the body is of vital
importance to a surgeon.
For example, if a neurosurgeon cuts into a blood vessel while extracting a tumor, severe
brain damage may occur.
Lab-on-a-chip systems
The advantages of such systems are the microvolumes of biological or biomedical
samples that can be delivered and processed for testing and analysis in an integrated
fashion, therefore dramatically reducing the required human involvement in many steps
of sample handling and processing, and improving data quality and quantitative
capabilities. This format also helps to reduce the overall cost and time of the
measurement and at the same time improves the sensitivity and specificity of the
analysis.
DISADVANTAGES [5]
1) Fabrication facilities are too expensive to be installed only for small volume
production.
(2) Because MEMS fabrication process differs from a device to another, a designer
should know many variations of processes; such high-level designers are very few.
(3) The optimization of a MEMS device requires many repetition of design modification
and trial fabrication. This makes the development phase long and costly.
(4) Those who want to utilize MEMS in various products may not have enough
knowledge of MEMS technology; thus they cannot take the full advantages of the
technology.
There is a need to reduce manual labor and human error as well as to increase reliability
and process automation. The kind of intelligence needed to achieve these objectives can
be provided with sensors. Sensors are used in equipment for surgical procedures,
intensive care units, hospital recuperative care, and home care. With medical
equipment manufacturers and sensor experts working together, state-of-the-art
technologies can be created. Selecting a sensor can be simple if the application and the
parameters that need to be controlled are clearly understood.
Implantable Sensors
Implantable sensors need to be small, lightweight and compatible with body mass as
well as require very little power. Most importantly, they cannot decay over time. The
power requirement is one of the major challenges for working with implantable sensors.
Sensors that can function with no power are perfect, but there are few in the market.
Piezoelectric polymer sensors are small, reliable, require no power and last for a long
time. Such sensors (miniature Piezo film sensor) can be used in pacemakers that
monitor activities of the patient.
There are other ways to power implanted sensors from external sources. When an RF
energy wand is brought close to the location of a specially designed sensor located
inside the body, the sensor wakes up, takes measurements, sends the data back to the
wand by RF link, and goes back to sleep. A sensor with an antenna and a transpondent
will do this job. As an example, an abdominal aortic aneurysm requires a portion of the
weak arteries to be removed and replaced with synthetic tubes. Such a sensor can be
implanted during the procedure to monitor the pressure leaks at the surgical location.
The requirements for sensors that can be inserted through an incision— typically
through a catheter—are less critical than those for implantable. Depending on the
surgical procedure, they need to function for few minutes to a couple of hours.
Ideally, these sensors do not require power to operate, but, if necessary, they can be
powered by external means.
A pair of matched thermistors can be attached to the tip of a catheter, which can be
guided to different locations of the heart to measure blood flow. These thermistors
don’t require external power. The figure shows this type of sensor.
Catheter ablation sensors are another example of sensors temporarily inserted through
incision to effect specific treatments and/or to take measurements during treatment. It
is critical that the force applied by the catheter tip to the target tissue not exceed
predetermined values to avoid any possibility of perforating the target tissue.
There are several disposable sensors where the sensor stays outside the body, but body
fluids come in contact with it. One example is disposable blood pressure sensors (DPS).
These sensors are used in surgical procedures and ICU to continuously monitor the
blood pressure of the patient. This is the ideal way to measure blood pressure when
intravenous fluids (IV) are administered to the patient. These sensors are replaced once
every 24 hours to maintain hygiene. This sensor module is plugged in to a monitor to log
all information.
A few other sensors come in contact with medication and/or body fluids. One is the
sensor used in the inflation of an angioplasty balloon. In this application, the pressure
sensor needs to withstand more than 30 bars and monitor the pressure applied to
inflate the balloon. Too much pressure can burst the balloon. Since medication and
body fluids are coming in contact, a silicone gel barrier is used to isolate the rest of the
sensor.
Medical devices use sensors for external applications in which neither medication nor
body fluids come in contact with the sensors. In most cases, these are non-disposables.
They can either be used in hospital or home care applications. Examples include:
• Load cells for infusion pumps that detect occlusion (tube blockage)
• MEMS-based flow sensors used in spirometers to measure breathing strength of
asthmatic patients
• Extremely small MEMS-based accelerometers to study tremors in Parkinson patient
• MEMS and load cell-based sensors for the conservation of oxygen and also to monitor
oxygen tank levels
• NTC temperature sensors to measure skin/body temperature
Infusion pump load cell to detect occlusion Reusable NTC thermistors used to measure
skin or body temperature
• Diagnostic
• Therapeutic
• Surgical
The objective of diagnostic system is to discover what is wrong with the people who are
ill. The rapid developments in the field of biochemical sciences, immunology, molecular
biology and semiconductor microfabrication technology has led to the concept of
microdiagnostic kits.
The principle of the microcantilever based diagnostic kit for tuberculosis is similar to
that of the diving board as the increase in the adsorbed mass of antigen 85 complex
causes the bending of the microcantilevers. But in addition to that, the specificity is
provided by the immobilization of antibodies specific for antigen 85 complex on the
upper surface of the microcantilever. When the biomolecular recognition takes place
between them, the adsorbed mass of antigen 85 complex causes the change in stress on
the surface of the microcantilever. The difference in stress at the top and the bottom of
the microcantilever beam causes the elongation of the upper surface of the
microcantilever and the shortening of its lower surface thereby causing the
nanomechanical bending of the microcantilever. The deflection of the cantilever can be
detected by optical, capacitive, interferometric or piezoresistive method.
Therapeutic System
Ocular drug delivery device [9] utilizes a passive delivery mechanism to eliminate the
need for control electronics and thus reducing the cost of the system. In order for the
device to be a viable treatment method for chronic diseases, it must be refillable to
allow repeated dosing for many years. Once implanted, the device must precisely and
repeatedly deliver accurate doses and hold enough medication for multiple doses prior
to refilling (~every 2 months). The device should be flexible and conform to the natural
curvature of the eye. An ocular drug delivery device and its placement relative to the
eye are illustrated in figure below.
The drug delivery tube diameter is set to less than 1 mm. For incisions of this size, the
eye is able to maintain its integrity without the aid of sutures. Support posts are
contained within the tube and the reservoir to prevent the top surfaces of the device
from collapsing when the drug is depleted. A normally-closed check valve prevents
backflow of fluids from the eye into the device. The valve opens above a certain cracking
pressure allowing drug to be dosed from the reservoir to the treatment site.
The intraocular drug delivery device is composed of three individual structural layers of
polymethyldisiloxane (PDMS). The top layer defines the chamber for the refillable drug
reservoir. The middle layer defines the delivery tube and check valve orifice. The bottom
layer forms the base of the device outlining the refillable chamber, delivery tube, suture
tabs, and check valve seat. This layer contains posts that serve as
(1) mechanical supports to prevent the tube or reservoir from collapsing and
(2) the valve seat for the check valve.
The reservoir is secured to the top of the eye, while the shunt is inserted into either the
anterior or posterior chamber (Figure a). A specific dose of medication is dispensed from
the device when the reservoir is manually depressed by the patient’s finger (Figure b).
The reservoir can be refilled with the same or different medication without additional
surgery (Figure c).
Surgery is the treatment of diseases or other ailments through manual and instrumental
means. New technologies and procedures have been focusing on minimizing the
invasiveness of surgical procedures. Advances in surgery have led to greatly reducing or
eliminating the invasiveness of surgical procedures.
Current robotic surgery systems have a number of benefits over conventional surgery.
Figure (a) shows an Intuitive Surgical Da Vinci robotic system. In this arrangement, the
surgeon sits comfortably at a computer console instead of having to stand throughout
the entire procedure, which can last up to 5 h. A three-armed robot takes his place over
the patient. One arm holds an endoscope while the other two hold a variety of surgical
instruments. The surgical team can also look at a video monitor to see what the surgeon
is seeing. The surgeon looks into a stereo display and manipulates joystick actuators
located below the display. This simulates the natural hand-eye alignment he is used to
in open surgery (Figure b). Since computers are used to control the robot and are
already in the operating room, they can be used to give the surgeon superhuman-like
abilities. Accuracy is improved by employing tremor cancellation algorithms to filter the
surgeon’s hand movements. This type of system can eliminate or reduce the inherent
jitter in a surgeon’s hands for operations where very fine precise control is needed.
Motion scaling also improves accuracy by translating large, natural movements into
extremely precise micromovements. These advances allow surgeons to perform more
complex procedures such as reconstructive cardiac operations like coronary bypass and
mitral valve repair.
Intuitive Surgical Da Vinci robotic system Intuitive surgical stereo display and joysticks.
PRODUCT DEVELOPMENT
When developing a MEMS-based product for the surgical market, it is important to keep
the end in mind. The greatest whiz-bang sensor design and fabrication technology will
not produce a marketable product if the right application is not chosen. The following
points should be taken care of while developing a BioMEMS device.
As when building any MEMS product, it is important to evaluate the market for the
device, and in this regard the surgical market is a good one. Targeting a disease for
which there are a large number of surgical procedures performed, such as heart, lung,
cancer, etc., will ensure that the device will receive the required attention from funding
sources, researchers, and surgeons. For example, coronary artery disease has a 120-
billion-dollar economic impact, which has fueled research and development of catheter
devices. The surgical device market has both low-volume/high value products and high-
volume/low-cost devices. The high-volume market is very price sensitive and has low
margins but high volumes, which are attractive to MEMS fabrication facilities.
While it is always important to know your target audience, this is especially important
when developing surgical tools. Partnering with surgeons and doctors early in the design
process yields a deeper understanding of the problems and issues faced in the operating
room. This can shorten the development cycle, as well as result in a tool which better
matches the surgeon’s needs. These surgeons and doctors will be the end users and
clinical champions of the surgical devices and can not only help MEMS engineers to
understand what the real problem to be solved is, but also ensure that the device is
accepted in the medical community. Interfacing early with the medical community will
help to determine if the surgical tool is really needed and if it will be used by surgeons.
Cost [4]
MEMS engineers should take an honest look to determine if MEMS really is the best
choice to solve the problem, or if competing technologies will perform better. Not only
must the surgical tool compete with other devices technically, but it must also compete
on a cost basis. This has become more important now that medical providers are under
great pressure to reduce costs. Before developing a product it is important to do the
math. The device must make a significant impact on a medical procedure to justify any
additional cost. In order to do this, MEMS engineers need to focus on disruptive
technologies which will reduce the skill needed to perform complex procedures and
allow them to be performed in more convenient and lower cost settings.
Biocompatibility [10]
MEMS devices which come into contact with the body must be biocompatible.
Biocompatibility is defined by The Williams Dictionary of Biomaterials as “the ability of a
material to perform with an appropriate host response in a specific application”. The
biocompatibility requirements vary considerably depending on the device function and
design; The ISO 10 993 standards outline minimum tests of material characterization,
toxicity, and biodegradation that may be augmented depending on actual device usage.
Biocompatibility is a surface-mediated property, and the biocompatibility of a device
depends only on those materials in contact with tissue. The biocompatibility of silicon
and other MEMS materials has become much more important with the advent of
implantable MEMS devices that interact directly with the body. Biocompatibility is a
surface-mediated property, and the biocompatibility of a device depends only on those
materials in contact with tissue. The biocompatibility of silicon and other MEMS
materials has become much more important with the advent of implantable MEMS
devices that interact directly with the body.
Packaging [5]
Packaged MEMS devices must be able to survive the sterilization procedures used in the
surgical environment. They must withstand exposure to high temperatures and
moisture in autoclaves and steam sterilizers. Alternative sterilization methods include
ethylene oxide and irradiation. Ethylene oxide is a harsh organic solvent and packages
must be made of a compatible material. For each application area the packaging
challenge is different. In addition, packaging costs are usually considerably more
expensive than the MEMS device itself.
Medical products, of which surgical tools are a subset, are subject to many regulatory
controls. The Food and Drug Administration (FDA) and European Community (EC)
determine whether a product is fit for sale in the United States and Europe,
respectively. Any MEMS devices which have biomedical applications (BioMEMS) such as
DNA chips, pumps, blood glucose detectors, catheters, cochlear implants, and blood
analyzers fall under their jurisdiction. Historically BioMEMS have had design cycles
between 5 and 15 years long. Of this time, one to two years have been used for getting
the necessary agency approvals. Agencies require that all claims be verified for
effectiveness and that the product has proven to be reliable in many sets of clinical trials
before they allow a product on the open market. The approval process for disruptive
technology can be substantially longer. These agencies also have current good
manufacturing practices (cGMP) on how medical devices must be fabricated. These
procedures establish a set of standards which aim to ensure that quality products are
produced.
Lengthy sets of clinical trials can be avoided if MEMS sensors are applied to existing
surgical tools and do not claim to alter the performance. Retrofitting existing surgical
tools is the preferred method of entry for MEMS companies because it is the fastest
path to market. Retrofitted tools have already been accepted by surgeons who are
familiar with their applications and use. Another advantage for MEMS companies is that
they themselves do not have to pay for costly clinical trials, which can be avoided by
modifying existing tools. If clinical trial cannot be avoided, MEMS companies can partner
with device manufacturers to reduce costs and use their expertise in trials.
Once a study is carried out as to the requirements of the surgeon or doctor a BioMEMS
engineer has to decide on the size, material, precision and accuracy, sensing element,
actuation element, type of link etc. In case of BioMEMS the selection of the material is
of utmost importance. Depending on the application of device either external or
internal, suitable material has to be selected. The material must not be degradable or
corrodible when it comes in contact with body fluids.
The software’s available for MEMS design are MEMCAD and CAEMEMS
Fabrication Techniques
Bulk Micromachining
Bulk micromachining is a fabrication technique which builds mechanical elements by
starting with a silicon wafer, and then etching away unwanted parts, and being left with
useful mechanical devices. The methods commonly used to remove excess material are
wet and dry etching, allowing varying degree of control on the profile of the final
structure.
Wet etching
Wet etching is obtained by immersing the material in a chemical bath that
dissolves the surfaces not covered by a protective layer. The main advantages
of the technique are that it can be quick, uniform, very selective and cheap.
Dry Etching
Dry etching is a series of methods where the solid substrate surface is etched by gaseous
species. The etching can be conducted physically by ion bombardment (ion etching or
sputtering and ion-beam milling), chemically through a chemical reaction occurring at the solid
surface (plasma etching or radical etching), or by mechanisms combining both physical and
chemical effects (reactive ion etching or RIE)
Surface Micromachining
into the bulk substrate, surface micromachining builds up structures by adding materials, layer
by layer, on the surface of the substrate. The thin film layers are typically 15 µm thick, some
acting as structural layer and others as sacrificial layer. Dry etching is usually used to define the
shape of the structure layers, and a final wet etching step releases them from the substrate by
removing the supporting sacrificial layer.
A typical surface micromachining process sequence to build a micro bridge is shown in Figure,
Phosphosilicate glass (PSG) is first deposited by LPCVD to form the sacrificial layer. After the
PSG layer has been patterned, a structural layer of low-stress polysilicon is added. Then the
polysilicon thin-film is patterned with another mask in CF4 + O2 plasma. Finally, the PSG
sacrificial layer is etched away by an HF solution and the polysilicon bridge is released.
LIGA
LIGA is a technology which creates small, but relatively high aspect ratio devices using x-
ray lithography. The process typically starts with a sheet of PMMA. The PMMA is
covered with a photomask, and then exposed to high energy x-rays. The mask allows
parts of the PMMA to be exposed to the x-rays, while protecting other parts. The
PMMA is then placed in a suitable etchant to remove the exposed areas, resulting in
extremely precise, microscopic mechanical elements.
Applications
Owing to the batch-mode manufacturing techniques borrowed from the integrated circuit industry, small size die,
and consequently large volumes and lower cost have become possible. These advantages have allowed
MEMS devices to displace old products while providing equivalent (or added) functionality. The various
applications of BioMEMS devices are shown in the figure below.
Cardiovascular Treatment
Ablation catheter – Force transducer measures precise location of catheter tip during
heart ablation to correct arrhythmia
Angioplasty Balloon Inflating Pump – Silicon MEMS pressure sensor measures inflation
of angioplasty balloon
Oxygen Conserver – Piezoelectric film or Silicon MEMS pressure sensor detects
inhalation and opens oxygen flow valve
Oxygen Tanks – Microfused™ load cells measure remaining oxygen level in tank
Patient Treatment
Ambulatory Infusion Pumps – Si MEMS pressure sensors or Microfused™ load cells used
to detect presence and/or rate of flow
Bubble and Level Detection – Ultrasonic sensors detect bubbles or medication levels
during infusion
Hospital Gas Monitoring – Si MEMS pressure sensors detect gas flow for hospital
medical gas systems
Infusion Pump – Piezoceramic diaphragm used to drive fluid at very slow rates
Kidney Dialysis – Microfused™ strain gage pressure sensor used to measure liquid flow
pressure
Surgical / Delivery
Baby Delivery System – Silicon MEMS pressure sensor used to monitor pressure on
vacuumassist baby delivery system
Body Heat Exchange – Si MEMS very low pressure sensor measures partial vacuum used
to expand the blood vessels for quick heat exchange
Disposable Digital Display – Low-cost Silicon MEMS pressure sensor with display
measures knee pressure during surgery
Kidney Transportation – Disposable blood
pressure sensors enable flow through organs during
transport to extend organ life.
CONCLUSION
REFERENCES
2. Nadim Dale Gee, Kurt E. Petersen, and Gregory T.A.Kovacs, Stanford University,
Center for Integrated Systems “Medical Applications of MEMS”
9. Ronalee Lo, Kenrick Kuwahara, Po-Ying Li, Rajat Agrawal, Mark.S.Humayun, Ellis
Meng, University of Southern California “A Passive Refillable Intraocular MEMS Drug
Delivery Device”