From the May 2016 issue of HealthCare Business News magazine
By Kenneth A. Fine
Traditional infusion therapies via a needle or catheter are sometimes superseded by less common drug infusions such as intramuscular injections and epidural routes.
Until the 1980s, all these procedures were done in a hospital. But now the mounting pressure to control health care costs is leading to more in-home and outpatient infusion therapy considerations, where possible. In addition, more novel infusion techniques and devices are being developed to administer a wide range of treatments including entirely new modalities, along with new and more effective drugs.
Therapeutic agents are emerging that are more complex than soluble drugs. Crossing the blood/brain barrier is an important challenge with great potential for new treatment breakthroughs. Iontophoretics can diffuse ions into the body, leaving fluid solutions behind. Gases can be infused to nourish biological materials until they are able to vascularize and grow. Biologics, including stem cells, gene therapy and recombinant therapeutic proteins may be used to treat a variety of medical conditions for which no other treatments are available.
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Depending on the substance being administered, the degree of medical supervision required and the location inside the patient’s body that must be reached, infusion devices may be as simple as an IV pump on a pole or much more high-tech, such as wearable and implantable devices. The most advanced systems that enable complicated applications or overcome unique challenges require a highly specialized approach to design, development, validation and manufacture. Some of the drug delivery issues these specialized designs overcome are temperature sensitivity, unstable and quickly perishable drugs or biologics and the sensitivity of the drug compounds with certain materials or pressure rates. These issues lead to innovations that have changed the landscape of infusion methods.
Going where no infusion device has gone before
For some applications, an implantable device is ideal. Downsizing their design is an important consideration: the smaller the device, the easier it is for the medical provider to implant and maintain, and the easier it is for the patient to live with. Yet shrinking the size of a device with complex functions creates new challenges. Batteries can be impossibly large for a tiny, complicated piece of equipment. In that case, pressure or chemical methods may be used to power the device. Frequently in an implantable device, a combination of chemical pressure and physics may be augmented with electronics to control the state and flow of the infusible solution. Other design characteristics will be dictated by the rate, be specified and tested for efficacy. Temperature control is designed into many infusion pumps as well, providing necessary preservation of chemical properties or fluid dynamics.