Micro Implants for the Ophthalmic and Intraocular Sectors
5/25/16 Micro manufacturing has played and continues to plan a significant role in the worldwide growth of ophthalmic devices. The enabling component is usually the smallest component in a medical or pharmaceutical implant or device. This is due to the discomfort of something large being put into the eye. When it comes to our eyes, the smaller the device the better.
Age related eye diseases such as cataracts, diabetic retinopathy, glaucoma and macular continue to cause loss of vision either significantly or completely. Ophthalmic and intraocular implants are largely made up of many micro sized and highly precise components and assemblies.
CONDITIONS AND TREATMENT: The eye is a complex and sensitive organ. There are many structures and targets, located closely together and sometimes, in terms of target for treatment, these structures are conflicting one another in their proximity. Existing in the eye are significant defense mechanisms, such as the tear film and the cornea, that present challenges for medication to enter. Specifically, the vitreous fluid is difficult for injected medication to traverse to reach the posterior of eye.
Anatomy of Human Eye, Photo credit- MasterEyeAssociates.com
A number of CONDITIONS of varying seriousness and interest
1. Glaucoma
2. Cataracts
3. Diabetic retinopathy
4. Age-related macular degeneration
5. Dry eye syndrome
6. Uveitis
7. Retinal detachment
8. Advanced Age & Lifestyle Diseases; still an extremely high level of unmet need
9. Other (Of lesser importance can be treated / managed with eye glasses, OTC medication, antibiotics, and specific hygiene protocols and, in limited instances, with surgery)
TREATMENT often requires contributions from two or more parts of an inseparable therapeutic triad
• Ophthalmic pharmacology
• Surgery of the visual tract
• Implantable ophthalmic medical devices
Highly innovative specialty companies define and epitomize the requirement for treatments of these conditions with micro sized and ultra-precision components and assemblies. Anyone who has ever worn corrective contacts and/or been on the bad end of a windy day near an outdoor fire pit, you have probably noticed that the smallest speck in your eye can cause you severe pain. The reasons for intraocular implants being micro-sized then are to provide the eye an extreme level of comfort with the least invasive, yet compliant implants in the human body. The thin and delicate structures of the eye require paper thin and flexible components that are nonetheless strong enough to withstand extreme fluid pressures in and behind the eye. The successful creation of a device that is both paper thin and strong is an engineering challenge that requires the skill and expertise that only micro molding and nano surface specialty companies can understand and implement.
Micro Engineering has been on the forefront of this developing technology and continues to be a leader in this field. For examples of our projects please refer to our parts pages.
Micro Sized Needle-free Drug Delivery Devices
5/19/16 Micro Engineering Solutions has been in the forefront with intraocular devices at the micro level, you can see some of our work on our Micro Molding Parts page. Why is the ophthalmic world going micro sized? It is due to the rising demand for painless drug delivery options, which has fueled the demand for needle free drug delivery devices significantly across the world. Transparency Market Research (TMR) released a report regarding the market global needle free drug delivery devices market, which stood at $5.4 billion in 2014, is projected to rise to $13 billion by 2023.
Transdermal patch
Jet injectors and other competing needle-free technologies, such as inhaler, novel needle, and transdermal patch, are the major technologies utilized in needle-free drug delivery devices. Needle-free technologies is likely to rise exponentially in the nearing future, due to the growing prevalence of needlestick injuries and the consistent advancement in jet injector technology.
Vaccine delivery, pain management, insulin delivery and pediatric injections are the main application areas of needle-free drug delivery devices. Latin America, North America, Europe, Asia Pacific, and the Middle East and Africa are the key regional markets for needle-free drug delivery devices. In 2014, North America and Europe ranked first and second, respectively, in the global needle-fee drug delivery devices market. Analysts anticipate North America to maintain its dominance in the near future. The advancement in drug delivery systems and the increasing investments in needle-free drug delivery devices to stimulate research and development activities are likely to boost this market significantly over the next few years. But who is anticipated to have the fastest growth rate? Asia Pacific, due to the increasing incidence of chronic health disorders, the infrastructural development in the healthcare industry, and the rising focus of major participants in this region.
Doctors, surgeons and patients are all screaming for non-invasive, minimal pain, easy administering drugs and procedures. Because of this the micro industry has grown exponentially and we are proud to be directly involved in this cutting edge technology. Please refer to our Micro Molded Projects to learn more.
Challenges in Bio-Resorbable Micro Molding
05/11/2016 The first challenge encountered by processors of bio-resorbables is material handling, which is the single largest area for error. Today we will be discussing micro molding in bio-resorbable PLA and PGA materials. There are many different compounds of PLA/PGA. Most common is the 82/18 version (82% lactide, 18% glycolide). A very high concentration of glycolide creates material handling and feeding difficulties due to the “gooey” nature of the glycolide. An abundance of information can be found using several of the bio-resorbable polymer suppliers (Purac, Boehringer Ingelheim, Lakeshore, DSM to name a few). When it comes to micro molding, however little information is available on the market due to proprietary processing techniques and lack of industry-specific testing for custom compounds.
Bio-resorbable scaffold
PLA/PGA materials are highly susceptible to moisture and heat. They must be stored properly (usually in a freezer) at a specified temperature in nitrogen-sealed foil pouches. They must then be used according to the processing run quantities needed and material drying cycle. The material usage must be matched with the injection screw and shot size in an injection molding machine so that the material is not sitting in an improperly sized machine where over-drying and over-heating can occur due to the prolonged temperature and drying exposure. This makes micro molding machines another key component to processing bio-resorbable polymers. Because they are highly shear and heat sensitive, proper fit of the shot size for a micro molded part to the screw and barrel is critical. The residence time (time the polymer sits in the barrel) can affect the IV (Intrinsic Viscosity) of the material. Small shot sized machines are typical in the design of micro molding machines. Some machines use reciprocating screws and some use screw over plunger technology. Some other machines are being developed by processors of bio-resorbable materials because even the smallest shot sizes available on the market are too large to properly process small amounts of bio-resorbable polymers. These machines are typically proprietary and primarily usesdinternally or through licensing agreements.
Many challenges exist in micro molding but there are ways to minimize these challenges and corresponding risk of failure to component manufacturers. In future blogs we will discuss other challenges in micro molding.