Scalability of Micro Intraocular Implants and Devices
9/29/16 Scaling devices from tens to hundreds of thousands or millions sometimes requires a tightrope balancing act of economies of scale and product and process robustness. Micro molding is a proven, scalable and economical process for thermoplastic micro-intraocular implants and devices. Recent developments and new to market intraocular devices and implants have led to the successful treatment of a number of ophthalmological conditions of varying seriousness and complexity such as:
- Glaucoma
- Cataracts
- Retinal detachment
- Diabetic retinopathy
- Age-related macular degeneration
- Uveitis
- Dry-eye syndrome
Treatment of these conditions often requires collaboration between ophthalmological surgeons, pharmacologists and micro-specific contract manufacturers. Development of these devices and implants occurs through a large number of highly focused, research-driven specialists (including micro fabrication specialists), such as:
Small, innovation-support funding programs
– Development companies that easily find a large marketing partner
– Big pharma funding the outsources of the development instead of doing it in-house
To design and build scalable intraocular implants and devices, the design and fabrication plan must include highly precise, micro sized component made from ultra-thin yet strong materials. These materials must be selected and characterized carefully to be robust enough to last for many years in a moist and warm environment.
In order to scale-up a polymer device that may have been born in an academic or laboratory setting, one must first understand the physical characteristics of the eye and how the surgeon will be installing the implant or device. The eye is a complex and sensitive organ with many structures and targets located closely together. These sometimes conflicting structures have significant defense mechanisms (tear film, cornea) that make it difficult for medication to enter. Vitreous fluid is difficult for injected medication to traverse to the posterior of the eye.
When designing and fabricating micro molded devices and implants for the human eye, the physical characteristics and material consistency of the components of the eye are critical to understand.
The anatomy and physiology of the eye is one of the most complex and unique systems in the human body. Many of these components of the eye are gelatinous, flimsy, easily punctured, and sensitive. As a result, the implants and devices that are installed must be free of sharp edges, excess material or flash, and have absolutely pristine surface finishes to help ensure both surgeon and patient compliance. The instruments, however, which cut or slice into various components of the eye to install the implants and devices must be very sharp and precisely made to create correctly sized and shaped incisions. Conversely, the instrument to hold or expand the eye open during surgery must be free from parting lines, flash or sharp edges.
Ophthalmologists are meticulously detailed surgeons with extremely good dexterity and their instruments must match their character traits, as their instruments and implants are considered an extension of meticulously planned and executed procedures. The many layers of the eye require the surgeons to switch quickly and accurately from one instrument to another because of the different surfaces they encounter in the eye.
US baseball star Yogi Berra once stated, “I’d give my right arm to ambidextrous.” But having the ability to switch hands and instruments and use both hands during eye surgery enables quick and precise positioning of instruments and safety and efficacy is maintained with instruments designed for the comfort and use in either hand. This requires a look at not only human factors, but also design-for-manufacturability, as the features and tolerances of the device and wall thickness and aspect ratios approach “design challenges” for a particular material selection.
The anatomy and physiology of the eye is one of the most complex and unique systems in the human body. Micro molding is a scalable process with particular design criteria met, including proper size, three-dimensional shape, wall thickness, material selection and surface finish.
Micro Components in Endoscopes
9/22/16 Endoscopes less than 20mm in size typically have between 10 and 20 very tiny, working (sliding, gear-meshing, and tight tolerance stack-up) components. Micro Engineering Solutions manufactures such devices in stages ensuring that the initial designs can be micro-machined until the assembly nuances are worked out. Surface and metrology data (and in-depth tolerance stack-up analysis) are established using assembly solid modeling, which is not only vital in terms of the form, fit, function of the working device, but also provides critical data used in automated assembly fixtures.
MUH component assembly with 75 micron sliding surfaces
Micro machining is a low-capital expense process that MES uses for the pilot production of endoscopes. When the design is “frozen” (i.e. testing has been completed, the part has been validated, assembled, and its functionally tested via accelerated age testing, ship testing, and sterility testing), the next level of production — when volumes increase and capital expenses can support a return on the capital investment for tooling, sintering, fixtures, and a more in-depth validation — may include micro metal injection molding.
Micro thermoplastic molding is also a viable alternative for some stainless endoscope components using strong and friction-friendly materials such as PEEK, ULTEM, and POLYCARBONATE, etc.
Micro-bubbles Allows Drug Delivery to the Brain
9/15/16 There was a recent article in Medical Physics Web that pertained to micro-bubbles being used to penetrate the difficult blood-brain barrier to get drugs delivered to a brain tumor. MES loves hearing about micro technology so we found this article very fascinating and we are excited at the technological advances that are currently taking place in the medical and pharmaceutical fields.
The blood-brain barrier (BBB), a protective layer of cells, limiting the delivery of most drugs into the brain is the reason why brain diseases are so hard to effectively treat. This new research combines pulsed ultrasound with injected microbubbles that vibrate in response to these sound waves to temporarily open the BBB.
This implantable ultrasound transducer is attached to the skull. It has no internal energy source, making it MRI-compatible, and is powered externally by a transcutaneous needle that is connected during treatment sessions.
This device has been tested in patients with recurrent glioblastoma (an aggressive and difficult to treat brain tumor). Preliminary results indicate that the device can safely disrupt the BBB and boost the amount of drug delivered to the brain.
“The blood-brain barrier is one of the last major frontiers of neuroscience,” said Carpentier, one of the researchers. “The publication of the trial results in one of the most prestigious US scientific journals is a major acknowledgment of this medical first.”
The device was implanted into patients divided into groups, each group getting a different acoustic pressure in order to determine at what pressure the BBB becomes disrupted. It was found that a starting pressure of 1.1 MPa was the most successful and detectable adverse side effects were not noticed. The trial is still ongoing to determine the maximum tolerated pressure. Preliminary findings suggest the approach is safe and well tolerated in patients with recurrent glioblastoma and has the potential to optimize chemotherapy delivery in the brain. It was also assessed that the patients that had confirmed BBB disruption had no detected tumor progression. While clinical trials continue, the thoughts of what other brain-related illnesses that can be effected by this new technology is very exciting!
Innovative Studies in Microfluidics
9/8/16 Microfluidic studies involve the study of the behavior of fluids in micro-channels and deals with the manufacturing of microfluidics devices for applications. Microfluidic device systems help to reduce side effects and improve the efficacy of medical treatments. It has many applications including inkjet printers, chemical synthesis, blood-cell-separation equipment, electro-chromatography, surface micro machining, biochemical assays, genetic analysis, drug screening, laser ablation and mechanical micro milling.
The increasing demand of microfluidic device systems from point of care testing and pharmaceutical industry are the major factors driving the microfluidic device system market. This market can be segmented into three major industries: pharmaceuticals, in-vitro diagnostics, and medical devices. Point of care testing, pharmaceutical and life science research, drug delivery, analytical devices, clinical and veterinary diagnostics, environment and industrial are the key applications involved in the microfluidic device system market.
MES has been involved in microfluidic projects, one is featured on our Micro Machining Projects page:
Microfluidic devices are designed to control extremely tiny droplets of fluid such as blood, drugs, or gel-like fluids. Tiny channels, v-grooves, holes, and valves are accurately positioned on tiny chips and surfaces to push, pull, pressurize, or atomize these fluids in order to give the microfluidic device the required functionality. Key to the efficient working of microfluidic devices are sub-micron surface finishes, extremely accurate adhesion and positioning of features in relation to other features, and an understanding of the fluid flow and interactions with external forces — such as static, temperature, pressure, and humidity.
MES creates features in the sub-micron range using several different processes including micro molding, micro machining, lithography, and direct ion etching. Some applications among many others that require this level of precision and positioning include microfluidic chips, insulin and other drug delivery valving, and drug aspirators.
Consistent Improper Use of Dry Powder Inhalers
9/1/16 A study of 54,354 inhaler user from 1975 to 2014 shows 31% of patients with asthma or COPD use their inhalers correctly, 41% had acceptable use and 31 % had poor use technique. The inability to use the inhalers correctly came from bad coordination, incorrect preparation, speed and/or depth of inspiration and post inhalation breath hold. This poor technique continues to be a major issue among both patients and health care professionals. Correcting this issue is key in combating lung related diseases. The data suggests that there remains an unmet need for simpler, easier to use inhaler devices.
That is where the DoseOne™ Single Dose Powder Inhaler comes in! This patented inhaler (US Patent #7,832,399 B2 & 8,360,057 B2) is a single use disposable dry powder inhaler that is:
– Vaccine-ready
– Easy to Carry & package for epidemic/pandemic necessity
– Fills a unique niche in the dry powder inhaler market
– Achieves new demanding regulatory requirements previously only achievable using complicated device designs such as:
• Dose counting
• Powder holdup
• Dose readiness indication
• Dose completion / user feedback
DoseOne™ is extremely easy to use and requires minimal training. The device, as currently designed, requires three steps to use:
• Removal from over-pack
• Actuation
• Inspiration
Actuation is a simple compressive snap and as a result of it’s simple operation, DoseOne™ has an excellent application in the delivery of drugs (such as vaccinations) to third-world countries.
This DPI is pilot-production ready and ripe for an active partner to bring it to market. It is already prototyped, tested, recently benchmarked, and ready for pilot production and a partner to move it forward. It can be tested in pilot production immediately because it is already designed, molded, and ready for slight modifications to fit a particular size molecule.
If you are interested in this product, please email DBibber@Dose-One.com for more details.