Assisted Drug Delivery Device
Transporting drugs to specific and appropriate tissues of the body is not a trivial issue and can be more important than the benefits of the drug itself. Characteristics of the target tissue and of the drug chemistry must be considered before a treatment can be effective. Delivery issues are largely linked with the drug's stability, mechanisms for metabolism of each drug, the tolerance and reaction of the body to the drug and the permeability of the target tissue. Engineering this reaction is a critical part of drug development and demands millions of dollars in development costs.
Currently, drug delivery techniques focus on moving drugs past our body's barriers and into the blood stream where it will be disseminated to organs and tissues. This is done through ingestion, inhalation, absorption and injection. However, the challenges increase: as a drug becomes more deleterious to the body, as with cancer treatments; with the expansion of pharmaceuticals into new and complex molecules; and when the target tissue is difficult to permeate.
Peptide, protein, and DNA therapeutics are not able to endure the standard mechanisms of drug delivery. These molecules are far less robust than small molecule drugs when given orally in pill form. Peptides and proteins are quickly digested in the stomach and most never reach the blood stream. The same is true for DNA therapies.
An important yet impermeable organ, the brain, is secluded by a blood barrier which allows very few molecules to cross and enter the brain. With little exception, only small molecules soluble in fat clear the barrier. Life-saving chemicals, if they happen to be the wrong chemicals, simply won't get through. Large-molecule drugs have the potential to cure patients with neurological disorders and cancer, but can not cross.
Based on evidence published in the early 1990's on the effect of high frequency, high power electromagnetic radiation on mammalian microvasculature conducted, in part, by the APL inventor; a microwave and/or radio frequency assisted drug delivery device was conceived to overcome obstacles associated with current methods of drug delivery. This device has been shown to enhance vascular permeability which maximizes targeted drug delivery. Therapeutic substances that do not normally pass from the bloodstream into tissues have been demonstrated to permeate targeted areas.
The exact mechanisms of this event are currently under investigation; however, based on research conducted to this point, it is hypothesized that MW/RF energy increases capillary blood pressure which opens gaps in the capillary walls, thus expanding the tissue to allow the introduction of large molecules. The phenomenon is further enhanced in the presence of vasodilatory substances currently available. Medical value of this technology is further enhanced by the fact that the induced permeability changes have been shown to be reversible with no long term damage or residual effects to the treated tissue.
The application currently being studied consists of a handheld microwave transmitter with focusing components and a power source that is capable of targeting and delivering safe amounts of microwaves (50% lower than the safety guidelines required by the FDA) to specific areas of the body. With further study of tissue behavior, the device will be frequency modulated to exact optimum changes in vascular permeability to accommodate different medical treatments.
The implications of this device in oncology, neurology and pharmacology are profound. Today, cancer patients are made ill by chemotherapy drugs that affect their entire body in an effort to reach malignant areas. Targeted applications and new, formally impermeable drugs could be utilized for more effective, less deleterious treatments. The blood brain barrier could be crossed and drugs to treat neurological disorders could be non-invasively introduced, replacing or enhancing marginally effective drugs and invasive deep brain electrical stimulation used to treat Parkinson disease, obsessive compulsive disorder, anorexia and other brain disorders. Pharmacological chemistry could be expanded to include large, less robust but effective molecules with less focus on delivery issues.
*Recipient of the 2004 Invention of the Year Award.CONTACT:
Mr. E. Chalfin
Phone: (443) 778-7473