Micro biomedical device size plays a role in effectiveness
7/29/15 Micro sized biomedical devices that are implanted into the body for drug delivery, tissue engineering, or sensing helps improve treatment for many diseases. But these devices are susceptible to being attacked by the immune system.
MIT researchers have developed a way to reduce this immune-system rejection. In a study that appeared in the May 18, 2015, issue of Nature Materials, they found that the geometry of these implantable devices has a significant impact on how the body tolerates them.
It was found that larger spherical devices are actually better able to maintain their function and avoid scar-tissue buildup, than smaller ones. All are still micro in size, but the smaller ones couldn’t withstand the immune system attacks as well.
The material it is made out of is still important, but you need to pick the right size and shape to decrease the scar tissue.
The researchers hope to use this insight to further develop an implantable device that could mimic the function of the pancreas, potentially offering a long-term treatment for diabetes patients. It could also be applicable to devices used to treat many other diseases.
In their studies they tested spheres in two sizes – 0.5mm and 1.5mm in diameter. In tests of diabetic mice, the spheres were implanted within the abdominal cavity and the researchers tracked their ability to accurately respond to changes in glucose levels. The devices prepared with the smaller spheres were completely surrounded by scar tissue and failed after about a month, while the larger ones were not rejected and continued to function for more than six months.
The larger spheres also evaded the immune response in tests in nonhuman primates. Smaller spheres implanted under the skin were engulfed by scar tissue after only two weeks, while the larger ones remained clear for up to four weeks.
This effect was seen not only with alginate, but also with spheres made of stainless steel, glass, polystyrene, and polycaprolactone, a type of polyester.
The researchers believe this finding could be applicable to any other type of implantable device, including drug-delivery vehicles and sensors for glucose and insulin, which could also help improve diabetes treatment. Optimizing particle size and shape could also help guide scientists in developing other types of implantable cells for treating diseases other than diabetes.
Single Dose Powder Inhaler Seeking Partner
7/21/15 A single dose powder inhaler is pilot-production and ripe for an active partner to bring it to market. Introducing DoseOne™, a single dose powder inhaler that is already prototyped, tested, recently benchmarked, and ready for pilot production and a partner to move it forward. The design is SO simple it’s something that makes you say, “Darn, I wish I thought of that, it’s so simple!”
Simple means inexpensive (~$0.30 USD in Full Volume) and fast to market and can be tested in pilot production immediately because it is already designed, molded, and ready for slight modifications to fit a particular size molecule.
DoseOne™ 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
– 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.
DoseOne™ is currently a three component inhaler with:
• All three components are highly manufacturable.
• Long term material selection which can be determined by the customer as a function of drug chemistry as the device design requires very few material constraints.
• Current performance data which utilized pharmaceutical grade/USP Class VI resins
Regulatory Advantages:
• DoseOne™ is a single dose device, minimizing dose-to-dose consistency risk.
• No device priming. Many inhalation systems require a prime of the device of a number of shot before use.
• DoseOne™ uses a new device for each dose and thus eliminates the issue of powder “caking and flaking” (deposition during inspiration adding to dose volumes of later doses).
• No dose counting! The FDA and other world health organization strongly recommend the use of dose counters or indicators to increase patient compliance. DoseOne™ is one device, one use, and disposable.
• The current device design contains a very simple dose readiness indicator as well as dose delivery indicator. This comes in the form of a viewing window to allow the user confirmation that the dose is ready, and that the dose has been delivered.
Development Status
• DoseOne has constructed tools for the current DoseOne™ designs (Size #2 and Size #4)
• Size #0 and Size #1 design embodiments are tooling kick-off ready. Feasibility, optimization, and DFM details are complete.
• Current single cavity tools are Phase I clinical ready
• Devices are currently in a molded and fully functional state
• US Patents are granted
– US PAT #7,832,399
• WWW.DOSE-ONE.COM
Partnering Expectations/Goals for DoseOne, LLC:
Micro Engineering Solutions has the exclusive rights to sell DoseOne™. Call us today to discuss your options
– Partner with successful formulations development/OEM companies interested in providing patients with effective treatment
– Develop mutually beneficial milestone based license arrangements which results in an expeditious time to market
– Continuously adjust and improve device performance as new formulations become available
– Supply the marketplace with a unique device partnered with an effective drug
Focus groups / Market Studies / Manufacturing Partners
Is This The End Of Insulin Injections?
7/15/15 A recently developed smart patch covered with mico needles can detect sugar levels in the blood and secrete insulin as needed. An article published in the Proceedings of the National Academy of Science talks in depth about this research.
The smart patch is smaller than a penny and is covered with one hundred micro needles. Each needle has a micro sized storage unit filled with insulin and glucose sensing enzymes that release insulin when blood sugar levels get too high.
This patch works fast, is easy to use and is made from non-toxic, biocompatible materials. The patch can be personalized to fit an individual persons needs (weight, sensitivity to insulin, etc).
Currently diabetics have to prick their skin multiple times a day and administer their own insulin. Besides the constant painful pricking of the skin, the dose of insulin is often administered incorrectly. This patch would solve all of these problems. More clinical studies need to be done before this patch can go on the market, but just imagine the potential!
MES has worked on similar patches, making hundreds of micro sized needles on 1 single tiny patch. It’s cutting edge technology and we are excited to be a part of it.
MICRO’s Future in the Medical Device and Pharmaceutical Sectors
7/8/15 In yesterdays world the procedure we followed was “diagnose, then treat” the problem with medical devices that were administered by a medical professional. Patients could self administer some medications in a pill form but other medications were administered as injectables by medical professionals.
In todays world we still practice “diagnose, then treat” but we have added a little preventative maintenance in the mix. Some medical devices are now patient friendly and an increasing number of medications are able to be taken by patients in the form of a pill or patch.
The future world is calling for “prediction and prevention”. Technology advances have been soaring and we have been developing ways to predict what ailments may be in a persons future. As these developments are progressing, the tools that enable the medical field to predict future ailments have encompassed micro sized components in both the medical devices and the drug delivery sectors.
In addition to this cutting edge technology is the rise of biological drugs that have a dual function. For instance, in the case of cardiovascular disease, the drugs both lower bad cholesterol and raise good cholesterol at the same time.
Imagine a world where chronic illnesses can be prevented! These are the types of projects we are currently working on and are proud to be a part of this advancement.