dmt medical sensors presentation

PARYLENE forMedical Sensors

January 2015

www.paryleneconformalcoating.com

© 2014 Diamond-MT. Company website: www.paryleneconformalcoating.com

PRESENTATION OUTLINE

• Introduction

• Parylene for Medical Sensors Overview

• Parylene Applications for Medical Sensors

• Summary

• Company Overview

• Contact Information

Introduction

What is Conformal Coating?

• Conformal coating is a protective nonconductive dielectric layer that protects electronic devices from damage due to contamination, salt spray, moisture, fungus, dust and corrosion caused by harsh or extreme environments.

• Conformal coating prevents damage from rough handling, installation, reduces mechanical and thermal stresses, thereby prolonging product life

• Conformal coating is clearly visible as a clear and shiny material, with some coatings being hard while others have a slightly rubbery texture

• Global market for conformal coating materials was valued at $7.9B in 2011, and is projected to $8.9B in 2017, a 5-year compound annual growth rate (CAGR) of 1%¹

• Demand for conformal coating is increasing due to more smaller form factor and more complex electronic assemblies for automotive applications, traffic control, outdoor surveillance, and military applications

• Traditionally a high cost process used for military and life/medical products, advancements in materials and processing have lowered the cost of and is now becoming increasingly common for consumer electronics


¹ BCC Research, 2011

What is Parylene Conformal Coating?

• Parylene is considered to be the ultimate conformal coating for the protection of devices, components and surfaces of all varieties

• Parylene is the generic name for a series of organic polymers• Polycrystalline and linear in nature, optically clear, and colorless

• Have excellent dielectric and barrier properties and are chemically inert.

• Contain no fillers, stabilizers, solvents, catalysts, or plasticizers

• Not subject to any outgassing or extraction issues

• Parylene provides dry film lubricity with coefficients of friction similar to Teflon with dielectric strengths up to 7,000 V at a mil (25 microns) of coating thickness. No other material can be applied as thinly as Parylene and provide the same levels of protection

• Parylene coatings are compatible and stable in the presence of bodily fluids and tissues, which are critical factors in the medical device industry


Parylene Deposition

• Parylene coatings are applied using vapor- deposition polymerization (VDP) in a vacuum chamber at room temperature. VDP processing is a clean, self-contained process that uses no additional chemicals.

• Parylene is deposited as a vapor, so it surrounds the target and penetrates and coat small cracks, crevices, and openings, and protect even hidden surfaces in areas where other coating methods such as sprays and brushes cannot reach

• Parylene coatings are ultrathin and pinhole-free with a uniform thickness even on irregular surfaces.

• Process Steps1. Raw material or dimer is placed into the vaporizing chamber at one end of the coating

machine

2. Dimer is heated, sublimating it directly to a vapor, and then heated again until the dimer

cracks into a monomeric vapor

3. Vapor flows into an ambient-temperature deposition chamber kept at a medium vacuum

(0.1 torr) where it spontaneously polymerizes onto all surfaces, forming an ultrathin, uniform

film. (No curing or additional steps are required)

4. Cold trap (-90º to -120ºC) to remove all residual parylene materials pulled through the

coating chamber


Parylene Conformal Coating Properties


Property Advantage

High Reliability Suitable for medical, military and commercial

applications

Moisture Barrier Low permeability to moisture and gases

Resistance Solvent, acid, base, radiation, fungus and bacteria

resistant

Bio-Compatibility Inert for medical applications

Conformity Excellent thickness uniformity

Electrical Breakdown Very high dielectric strength

Transparency Optical quality thin film

Mechanical High tensile and yield strength

Stress-Free None or very little effect on electronics and sensors

Low Friction Dry film lubricant

Light Weight Compared to other coatings

Out-Gassing Virtually none

Operating Temperature Wide range; ±200ºC

Parylene for Medical Sensors Overview

Medical Applications Challenge

• Sensitive medical device components, such as sensors, require absolute protection both inside and outside the body to be effective

• Bio-medical surfaces typically require conformal coating to protect from moisture, chemicals, and other potentially harmful substances. For example, implantable devices need long term protection against body fluids, enzymes, proteins, and lipids

• Moisture, electrical charges, bodily fluids and contamination can render a life-saving medical device useless

• Failing medical devices can put patients at significant risk

Parylene conformal coatings for medical device are up to the task!


Traditional vs. Parylene Conformal Coating

TRADITIONAL CONFORMAL COATING

•Traditional medical device coatings, such as wet chemistry and liquid coatings (i.e. silicones, acrylics, epoxy, or urethanes) are:

• Solvent-based• Imprecise, can not be applied with adequate control• Do not meet biocompatibility and toxicity requirements

•In short, other conformal coatings are unsuitable for use within the human body

PARYLENE CONFORMAL COATING

•Parylene is unaffected by moisture (water, blood or perspiration), chemicals, solvents and gases, and resistant against bacteria, fungus and corrosion, making it ideal for medical applications such as surgical tools, needles and device components such as sensors

•Parylene does not out-gas and is very effective against transferring contaminants from the body to substrate and vice versa

Parylene is the conformal coating of choice for the medical and biomedical industry


Parylene Advantages for Medical Sensors

BIOCOMPATIBILITY

• Biostable and biocompatible coating (FDA approved)

BARRIER PROPERTIES

• Excellent moisture, chemical, and dielectric barrier properties

• Uniform protection of the sensitive electronics from medical applications in environments ranging from inside the body to the lab

LIGHWEIGHT & NO STRESS

• Negligible weight and thickness added to medical devices employing sensor technology

• Very low stress enables the application of Parylene directly on some sensor devices with little or no effect on the sensor performance



MATERIALS

• Parylene is compatible with most types of substrates, including glass, metals, elastomers, ceramics, plastics, paper, fabrics, silicone rubber and even granular materials

CONFORMITY & THICKNESS

• Parylene conforms to any shape, even sharp edges or points, have made it the only choice for biomedical manufacturers requiring conformal coatings for medical devices

• Parylene can be applied in various thicknesses; from a couple of mils to a few hundred angstroms

• Parylene is pin hole free and contains no additives



STERILIZATION

• Implantable devices and substrates using Parylene coating for protection may be required to be sterilized once or repeatedly

• Sterilization is intended to destroy all microbial contaminants on the surface of a medical device without degrading the function or useful life of either the sterilized item or its coating

• Parylene withstands all common sterilization methods; steam, ethylene oxide, electron beam, hydrogen peroxide plasma, and gamma radiation

• Repeated electron beam and gamma radiation sterilization tests proved no impact on tensile strength, tensile modulus, coefficient of friction, moisture vapor transmission, and dielectric strength¹


¹ MDDI Online, 2002

Medical Device Compliance

FDA APPROVED

• Parylene is an FDA approved material based on testing performed under USP Class VI bio-compatibility rating; safe for use within and outside the body

• Conforms to material ISO-10993 Biological Evaluations for Medical Applications

• Parylene is transparent, flexible and can be applied as a film in layers as thin as 0.1 mil to provide pinhole-free and conformal coating, even on complex surfaces common in medical applications.


Parylene for Medical Sensor Applications

Medical Sensors | Overview

• A major market trend for medical applications is the growth of disposable devices, home healthcare, diagnostics and health monitoring enabled by handheld electronics and sensors

• 2 of 10 sensor market trends at CES 2014 are directly related to health monitoring: wearables and chemical / bio sensors

• Sensor technology developments promise to enhance patient care and outcomes. For example, microfluidics, advanced bio-sensing, capsule endoscopy and personalized medicine


Source: Wiki-Health

Health Sensor Data Gathering Devices

Medical Sensors | Overview

PARYLENE MARKET TRENDS

• Emerging trends such as minimally invasive surgery, micro and nano medical devices require new and different packaging solutions

• Many devices used for diagnoses or analyses are in intimate contact with body tissue or fluids, and can not harm the human body

• Implantable devices often incorporate microelectronic components such as sensors and require isolation from moisture, chemicals, electric potentials and other substances

PARYLENE APPLICATION EXAMPLES

• Stents• Cardiac assist devices• Electrosurgical tools• Cochlear and ocular implants• Mandrels and molds• Catheters• Elastomeric seals• Needles and epidural probes• Medical electronics


Medical Instruments | Ultrasound

INTRAVASCULAR ULTRASOUND (IVUS)

• IVUS is a medical imaging method that uses a catheter with a miniaturized ultrasound probe

• Parylene provides the ultimate moisture and dielectric barrier protection

• Parylene helps minimize failures in the integrated electronics while providing biocompatibility and excellent lubricity to the catheter and its ultrasound sensor elements


Source: St. Jude

Parylene covered probe uses ultrasound technology to see from inside blood vessels,

enabling the doctor to see the vessel’s inner wall

Medical Instruments | Catheters

MEDICAL CATHETERS WITH SENSORS

• Catheters are medical devices that are inserted in the body to treat disease or perform surgical procedures

• Advanced catheters use temperature sensors to perform function such as monitoring core body temperature or pressure sensors for blood pressures, spinal pressures, tumor pressures or airway pressures

• Parylene coating is ideal as a dry-film lubricant, which is an absolute requirement for devices like catheters


Source: AliMed Innovative Solutions

Catheters with temperature sensor for pre, intra and post

surgery temperature monitoring

Medical Implants | Cardiac

Implantable Cardioverter Defibrillator (ICD)

• ICDs are implanted in patients at risk for recurrent cardiac events and require highly precise and reliable internal circuitry with life literally depending on them

• Parylene coatings provide moisture barrier, dielectric barrier, and biocompatibility properties that are critical to these devices.

• Short circuits are prevented, yet Parylene does not add weight or compromise the electronic circuitry in any way.

• Parylene provides a protective sealing for people who are allergic to the metal casing of a cardiac implant


Source: St. Jude

Parylene is used to cover the ICD casing as well as the leads that are connected to

a patient’s heart

Medical Implants | Hearing

HEARING IMPLANTS

• Hearing implants can be as small as a grain of rice. At this size, the device can not be properly coated with any material that adds significant weight or thickness or is not biocompatible

• Micron-thick film, vapor-deposited Parylene can protect this type of device and adhere to long-term performance requirements

• Some analog devices require manual settings or replaceable batteries. Parylene has very little effect if a case must opened or a through-the-enclosure dial must be turned

• Parylene is also known in sensor manufacturing, for example, creating Parylene suspended diaphragms for MEMS speakers in hearing aid applications


Source: Medgadget

Fully implantable hearing aid with PZT sensor that serves as a

microphone

Medical Implants | Eye

RETINAL IMPLANTS

• Degeneration of retinal cells are leading causes of blindness affecting an estimated 25-30 million people worldwide

• Retinal implants under development can be deformed, allowing the implant to conform to the natural curve of the eye

• Entire implants can be coated with Parylene and the active surface of the stimulation electrodes is opened by plasma etching


Source: MEMS Journal

Artificial lens implant, coated with Parylene

Other Medical Devices | Smart Pills

ENDOSCOPY

• Capsule endoscopy is a MEMS enabled innovation as an alternative to colonoscopies and esophagogastroduodenoscopy (EGD)

• A pill-sized camera featuring MEMS technology allows for imaging of the gastrointestinal tract without the need for invasive procedures

• Smart pills must withstand harsh conditions inside the human body, including corrosive digestive acids that can potentially destroy microelectronics


Source: MayoClinic.com

Parylene remains clear after it has been cured, which is ideal for pills that house

micro-cameras or high-precision imaging sensors

Other Medical Devices | Smart Pills

DRUG DELIVERY

•MEMS-based ‘smart pills’ can assist in targeted drug delivery

•Smart pills must be safe for human consumption and not cause any adverse effects to the patient’s body

•Medical device companies routinely use protective Parylene coatings to ensure that the MEMS is not damaged


Source: Medical Design

Parylene is an ideal solution for smart pill protection, being chemically inert, with low coefficient of friction, and

featuring USP Class VI biocompatibility

Other Medical Devices | Diagnostics

PORTABLE DEVICES

• Portable diagnostic devices can be used by patients at home, first responders in the field, battlefield medicine, and clinicians in remote areas of developing nations

• Diagnostic and monitoring devices, such as ECGs, blood pressure devices, and even pathogen sensors that test both water and air for viral agents, employ advanced sensor and MEMS technology for portability

• Portable medical devices are exposed to rugged conditions and potentially harsh environments. It is imperative that the sensitive electronics are well protected by conformal coatings such as Parylene


Source: Omron

Portable Blood Pressure Monitor

Many portable medical devices need to be able to withstand moisture, chemicals, abrasion, and even harsh sterilization

processes

CONCLUSION

CONCLUSION

• Parylene coating has been used to protect components in the medical industry for over 35 years

• With the growth of new minimally invasive surgical procedures and implant technologies, the greatest benefit of Parylene coating is bio compatibilty

• Parylenes is FDA approved and does not affect the body in any negative way

PARYLENE OFFERS THE FOLLOWING ADVANTAGES

• Superior electrical propertiesas compared to other conformalcoatings

• Exceptional moisture protectionbarrier properties

• High tensile strength

• Thermal stability

• Stress free

• Chemical and solvent resistance

• Dry lubricant film

• Can withstand sterilization

• High degree of adhesion

• Biocompatible and biostable

• Particle immobilization

• FDA approved


COMPANY OVERVIEW

• Founded in 2001

• HQ in Johnstown (PA) with global partners in Shenzen (China) and Manchester (UK)

• Specializes in conformal coatings for electronics and sensors

• Provides complete range of conformal coating services

• Develops and formulates custom chemistries

• Manufactures and sells automated equipment

• Consults with advanced coating projects

ABOUT Diamond-MT


CONTACT DETAILS

CONTACT DETAILS

Diamond-MT213 Chestnut StreetJohnstown, PA 15906

Email

[email protected]

Phone

814.535.3505

Fax

814.535.2080

Website

www.paryleneconformalcoating.com


dmt medical sensors presentation

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