Magnetic Treatment Device

A. Sleepy Driver and Insomnia

The development of this device is being done in two phases. First, develop a device to monitor a sleepy driver or equipment operator. This would be accomplished by non-invasively measuring the driver's brain waves. This could be done by measuring the brain's electrical activity through EEG electrodes. The progression from an alert to drowsy condition results in slower brain waves. The device will alert the user to the potentially unsafe condition. The device could also take corrective action when such a condition occurred. This would be accomplished by increasing the speed of the brain waves through magnet therapy using sympathetic vibration and brain entrainment to stimulate brain waves at specific frequencies. The sales would be approached as a personal and public safety issue. According to the National Sleep Foundation's 2002 Sleep in America poll, 100 million people said they had driven a vehicle while feeling drowsy last year. Thirty two million have actually fallen asleep. This has major implications for the NTSB as well as law enforcement and the insurance industry.

The technology used in the device would also have applications toward treating insomnia. The hypothesis is that by decreasing the speed of the brainwaves it will be easier for the individual to sleep. The National Sleep Foundation's 2002 Sleep in America poll shows that 58% of adults in the U.S. experience symptoms of insomnia a few nights a week or more. According to the National Institute of Health, insomnia affects more than 70 million Americans. Direct costs of insomnia, which include dollars spent on insomnia treatment, healthcare services, hospital and nursing home care, are estimated at nearly $14 billion annually. Indirect costs such as work loss, property damage from accidents and transportation to and from healthcare providers, are estimated to be $28 billion.

B. Irritable Bowl Syndrome (IBS); obesity, and gastroparesis

Irritable bowel syndrome (IBS) is a disorder that interferes with the normal functions of the large intestine (colon). It is characterized by a group of symptoms; crampy abdominal pain, bloating, constipation, and diarrhea. According to the National Institute of Health, one in five Americans has IBS, making it one of the most common disorders diagnosed by doctors. It occurs more often in women than in men, and it usually begins around age 20.

Research suggests that people with IBS seem to have a colon that is more sensitive and reactive than usual to a variety of things, including certain foods and stress. Some evidence indicates that the immune system, which fights infection, is also involved. IBS symptoms result when the normal motility of the colon may not be working properly. It can be spasmodic or can even stop temporarily. Spasms are sudden strong muscle contractions that come and go.

Colon motility (the contraction of the colon muscles and the movement of its contents) is controlled by nerves and hormones, and by electrical activity in the colon muscles. If the muscles of the colon, sphincters, and pelvis do not contract in a coordinated way, the contents do not move smoothly, resulting in abdominal pain, cramps, constipation or diarrhea, and a sense of incomplete stool movement.

The use of magnetic fields could treat the abnormal electrical activity that accompanies the disease by modulating muscle tonicity. The approach would be to focus efforts on modifying the activity of the gastric pacemaker. Residing in the mid corpus of the stomach, the pacemaker sets the pace for electrical activity produced by smooth muscles in the stomach. The electrical activity produces slow waves that spread toward the pylorus. The frequency of the gastric slow wave is about 3 cycles per minute in humans, and is responsible for determining the frequency and propagation of gastric contractions. The hypothesis is that by modulating gastric contractions, the subsequent symptoms of IBS will be treated. Modulation of the gastric pacemaker could also be effective in gastroparesis. Nearly one third of the adult population is considered obese and recent clinical trials in the US showed that a device that delivered a mild burst of electrical current every three seconds to the stomach wall was effective in treating obesity. The major difference would be that in AGC's device, the energy would be delivered magnetically.

Theory of Operation

The innovative approach would be to use pulsed magnetic fields (PEMFs) to stimulate the neurons responsible for desired effect. The beneficial effects of PEMFs have been shown since the early 1970's. The majority of the work has been done to augment bone healing in patients. As the cellular and subcellular mechanisms have been elucidated for the beneficial effects of PEMFs, specific requirements to treat a variety of disease states are emerging. These include nerve regeneration, wound healing, and graft behavior, among other illnesses (1).

Technology

Of specific interest is nerve stimulation with PEMFs. Kartush investigated stimulation of the facial nerve with both magnetic and electrical stimulation. His results demonstrated that magnetic stimulation was more comfortable, because high current levels were not required at the skin surface. He also demonstrated that magnetic and electrical stimulation of the facial nerve resulted in nearly identical muscle action potentials, indicating that the sites and mechanisms of neural depolarization are similar (2). Subsequent to this work there have been further efforts to study magnetic stimulation of neurons. Most of these efforts have focused on stimulation of neurons in the brain. More recently, a device has been developed that stimulates peripheral neurons of the pelvic floor that is used in the treatment of patients with urinary incontinence.

This device is described under patent US 6086525. As described in the abstract of this patent, the major advantages of this design over previous efforts at PEMFs can be described as follows. First, the core is constructed from a material having high field saturation, namely vanadium permendur. Other materials may be used but should have a field saturation of at least 1.5T. Also, the shape of the coil is important in order to focus the field at the desired neurons. This present device uses a C-shaped coil. Various spanning degrees from 180 to 220 degrees can be used. Another important factor is the design of the discharge circuit. For the treatments mentioned in this patent, discharge rates of 5 to 50 Hz having a decay time of about 100 microseconds are needed. The device must be efficient and reliable to fire at such a high rate. The three main target applications for this device are incontinence, muscle rehabilitation, and weight management (3).

Another patent of interest for PEMFs is described in US 6066084, Method and Apparatus for Focused Neuromagnetic Stimulation and Detection. This method of stimulating neuronal tissue uses novel coil geometry and firing circuits. By placing coils in parallel and orthogonal configurations, currents in adjacent coils are directed in opposite directions to provide cancellation near the surface of the coil and peak field focus in the target region. The depth and position of the electrical field can be adjusted (4).

Most of these devices have suffered from the problems of lack of the ability tofocus the magnetic field, a high voltage power supply, the need for a large instantaneous power output of the high voltage power supply, and a large reservoir capacitor. A design that improves on these problems is described under patent US 5766124, Magnetic Stimulator for Neuromuscular Tissue. The main advantage of this design is the use of multiple capacitors to recover energy from the stimulating coil (5).

It is clear from a review of the current state of the technology that there are multiple approaches to the use of PEMFs with no clear advantage among the various designs. No device using PEMFs has been developed for the indications proposed by our Company. The magnet treatment device will improve on the present designs by using novel coil designs, new magnetic materials, improved circuit design, firing rates of different frequencies and excitation patterns, and the use of electronically controlled and modulated constructive and destructive interference patterns to more effectively focus the PEMFs. The applicability of these new designs in the treatment of the proposed diseases will then be investigated to determine their safety and efficacy.

Current Competitive Products

The current magnetic therapy device market is predominately bone growth stimulation device manufacturers. The companies include Biomet Orthopedics, Inc., DJ Orthopedics, LLC, Orthofix International N.V., and Orthologic Corp. According to BCC, Inc., the worldwide market for 2004 was $ 480 million and is forecast to grow to $ 950 million by 2009. Other magnetic device manufacturers include Neotonus, Inc., Caldwell, and Magstim.

None of these products are currently being used in the indications proposed by our Company. Our advantage will be our technology and patent strategy specifically to circumvent the current competitors and also creating barriers to any further portfolio development by them.

References

Bassett CA. Beneficial effects of electromagnetic fields. J Cell Biochem 1993 Apr; 51(4):387-93
Kartush JM, Bouchard KR, Graham MD, Linstrom CL. Magnetic stimulation of the facial nerve. Am J Otol 1989Jan; 10(1):14-9.
Davey, KR, Epstein CM. Patent US5725471; Magnetic nerve stimulator for exciting peripheral nerves.
Edrich J, Zhang T Patent US6066084; Method and apparatus for focused neuromagnetic stimulation and detection.
Polson MJR. Patent US5766124; Magnetic stimulator for neuromuscular tissue.