micro parts to market... faster

Micro Electronics in a Hydrogel Based Bandage

063016     Researchers at MIT have developed a hydrogel-based bandage embedded with micro-electronics and drug-delivering reservoirs for a wound-care solution that can monitor vitals (such as temperature), release drugs if needed, and light up if the medication is running low. The material is stretchable making it more compatible with the body’s structure than traditional dressings, and it may be useful for applications both inside and outside the body.
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Recent advances in biomedical hydrogels have increased their popularity among engineers looking to develop next-generation medical devices, such as contact lenses, drug delivery devices, and tissue engineering scaffolds. The softness, flexibility, and porosity of hydrogel’s structure is similar to organic tissue, making hydrogels uniquely biocompatible.
Most electronics are hard and dry, not compatible with the human body. This bandage has electronics in it that are soft and stretchable. This challenges in developing this were the mechanical
strength and ability to cling to porous surfaces. The researchers developed a hydrogel capable of dissipating the energy required to stretch it and chemically anchored to form covalent bonds with various surfaces.
The bandage tracks the temperature of the wound and releases drugs from reservoirs that are diffused through the hydrogel over an extended period of time. In addition, embedded LED lights are programmed to light up when the reservoirs have emptied. This technology could be applied to implanted glucose monitors and neural probes at some point.
The focus of bandage improvement is a hot topic in todays day and age. Researchers around the world are looking for ways to incorporate smart electronics into wound dressings. A German team is working on a bandage that changes colors in response to pH levels in the skin, and a team from UC Berkeley is developing a skin sensor that can detect a bedsore before it begins to form. Miniaturized technology and a better understanding of human response will lead to a more intelligent or “smart” bandage.

 

Micro Medical Swimming Devices

6/24/16     Micro components have become a staple in medical devices and pharmaceutical drug delivery. Micro Engineering Solutions has been an integral part of many micro component projects, you can see some of our projects on our parts and projects pages.
Scientists at the University of Sheffield are working on a project that is right up our alley and we wanted to share it with you. They are working on tiny spherical bead-like devices can be guided by physical structures while swimming inside fluids. The team believes its research could lead to using structures in the body to guide drug delivery and exploration.
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These micro sized devices, which are a similar size to cells and bacteria, might find applications in the delivery of drugs to a specific location inside the body or outside of the body to diagnose diseases in blood samples. This could include finding proteins that indicate cardiac problems or find circulating tumor cells that can indicate the spread of cancer.
The research conducted at Sheffield relies on a new technique, giving the devices a catalytic coating on one side, which creates a chemical reaction when fuel molecules are added, causing the device to move automatically on a pre-determined route. They are currently working on the problem of this device being bounced around by other objects in the fluid of the body, with hopes of using body material and parts to use as guiders.
Working in this field is very fascinating and rewarding. It will be interesting to see what the future holds for micro component medical devices!

Partnership in Drug Delivery Powder Inhalers

6/13/16    Dry Powder Inhaler: development of the DoseOne™ single dose powder inhaler (US Patent #7,832,399) required a multi-disciplinary team approach, as any such drug delivery device needs to combine not just design skills, but also software and mechanical engineering capabilities, and expertise in analytical science and industrialization. MES has the exclusive worldwide rights to sell DoseOne™ and is actively seeking serious and interested partners. The design of this powder inhaler is sympathetic to the requirements for mass manufacture and regulatory compliance.
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.

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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.

 

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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

MICRO is the Key Factor in the Medical and Pharma Fields

6/9/16     Medical device, electronics, and biopharmaceutical manufactures need new products that create tinier, less invasive, fluid-induced, and/or space saving micro devices.  These products require integrated, micro and automated solutions to ensure their success out of the gate.  The tiniest parts in an assembly are the ones most likely to be a challenge and are also usually the enabling component of the entire devices form, fit, and function.  Many new advances in micro technology have been developed worldwide for the creation of microscopic features and components.  More advances of micro molding technology will push the envelope of tiny components and features enabling even smaller micro devices of the future.

Micro Components are KEY in the Treatment of Eye-related Illnesses

6/2/16   There are many illnesses that plague the eye. Below are a few examples and how micro-sized components aid in the treatment of these illnesses.

Glaucoma affects many elderly, African Americans, and those with a family history.  It is considered the 2nd leading cause of blindness (after cataracts) and is principally caused by elevated intraocular pressure within the eye.  Micro surgical devices and intraocular implants are used if eye drops are not an effective treatment.  Micro components and surgical treatments include:

  • Trabeculectomy (laser surgery) is most common approach; creates a hole in sclera to allow fluid to drain into the outer cyst
  • Conventional surgery can also be used to create a drainage hole in the white part of the eye if laser surgery is unsuccessful
  • Implant surgery positions a device to aid the drainage; estimated that several thousand are performed each year in US
  • Canaloplasty places a microcatheter into Canal of Schlemm to enlarge the natural drainage channel for healthy eye

micro glaucoma drain

A glaucoma drain, commonly known as a shunt, is shown in the above image.  This shunt is injection molded, spherically shaped with a wedge-shaped radial side action in the tool that creates the drain geometry.  At the end of the side action travel is a 250 micron orifice whereby no flash can be tolerated.  Shunts are mostly tubular, however this one is 3d shaped and designed for placement in the sclera (side of the eye).  It is designed to act like a venturi system which uses the pressure of the eye to push the discharge from glaucoma to behind the eye where it can drain.  In addition to the 250 micron entry orifice, there are 4 suture holes of 250 micron diameter (2x a human hair) molded into the top of the implant.  These suture holes also must be free and clear of particulate or flash to prevent sutures from cutting during implantable or after surgery.

 

Age Related Macular Degeneration (AMD) is the leading cause of permanent impairment of reading ability and loss of fine detail for those over age 65.  The macula is the central portion of the retina used for seeing fine detail and can be destroyed in one of two ways beginning at age 60. In 2004, 1.5% of adults over age 40 experience advanced AMD and 6.1% had intermediate AMD (1.8 and 7.3 million adults, respectively). The dry form is the most common form of AMD but it can become the wet form which is more destructive. In dry AMD light sensitive cells in macula break down. Dry AMD is treated with oral ingestion with a high dose of anti-oxidants and zinc. Wet AMD is characterized by growth of abnormal blood vessels behind the retina. Laser surgery used in a small % of patients to destroy vessels but the treatment also damages the retina. Another treatment approach involves intravenous injection of a photo activated drug into the arm. When exposed to light in the eye the drug is activated and it destroys the new unwanted blood vessels. Injections into the eye to block the growth of abnormal new blood vessels is also available. Prior to 2007, medicine was not available to treat AMD; in 2007 the market was estimated to represent more than $1.2 billion in sales.

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The above image shows an AMD guidance device used in laser surgery.  The spherical radius sits on the cornea and the lens underside must be free of flash, mold parting lines, and surface imperfections.  The 300 micron laser hole shuts off on the spherical radius and blending these geometries three-dimensionally in steel to produce the polymer micro injection molded component is very challenging.

 

Dry Eye is one of the most common reasons for an appointment with an ophthalmologist.  Dry Eye condition is defined as an irritation of the eye due to an inability to produce or maintain/retain enough tears on the surface of the eye.  It can result in damage to the front surface of the eye and impair vision.  The causes vary from specific diseases (such as Sjögren’s syndrome or lacrimal and meibomian gland dysfunction) to other causes including age, gender (women are more susceptible), medications, certain medical conditions, environmental conditions such as exposure to smoke, wind, or dry climates, and other factors such as prolonged use of contact lenses or refractive eye surgeries (LASIK).

Treatment, may require micro components (approximately ¼ the size of a grain of rice) include punctal plugs (See Figure 1.4) whereby a plug is surgically placed in both the top and lower eyelid to prevent fluid in the eye from draining, thereby keeping the eye hydrated.   Additional treatments use OTC eye drops or prescription lubricants and anti-inflammatories. These medications are extremely costly and if not administered properly (balancing the dropper over the eye and making sure it all gets into the eye) defeats the purpose and wastes consumer and healthcare costs.  Much effort is put into micro pumping and micro administering of these fluids with aspirators, implantable pumps, and slow release polymers that release the drug in timed increments.

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Punctal plugs placed in drainage channels of the upper and lower eyelids. Photo credit- allaboutvision.com