Techniques using heat flow management, stimulation, and signal analysis to treat medical disorders

Abstract

A device and method of use for treating a medical disorder by surgically implanting into a patient at least one sensor element capable of detecting and conveying cell signals; attaching a management unit such that a micro controller of the management unit is connected to at least one sensor element; and connecting the management unit via a lead bundle to at least one treatment device. The treatment device may be an electrical stimulation device, a magnetic stimulation device, a heat transfer device, or a medication delivery device. Responsive to signals from the one or more sensor elements, mathematical algorithms of the management unit use wavelet crosscorrelation analysis to prompt delivery of at least one treatment modality, such heat transfer, current pulses, magnetic stimulation or medication. The medical disorder may arise from the brain, central nervous system or organs and tissues outside of the central nervous system.

Description

[0001] This application claims priority to U.S. provisional patent applications Nos. 60 / 160,328, filed Oct. 19, 1999, and 60 / 201,188, filed May 2, 2000, which are hereby incorporated by reference.BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The invention pertains to a method of treating a medical disorder using heat transfer, electrical stimulation, and / or delivery of medication so as to stop or prevent abnormal cell activity, thus treating the disorder to improve function of an affected body tissue. The method improves effectiveness of stimulation for treating disorders of function of brain or elsewhere in central nervous system, or in peripheral nerve. The method may be used to treat epilepsy, for treatment of brain disorders other than epilepsy, for spinal disorders, and for disorders of other body organs and tissues. [0004] 2. Description of Related Art [0005] Epilepsy is a significant medical problem, as nearly 1% of the United States population is affect...

AI Technical Summary

Benefits of technology

[0024] In another preferred embodiment, the invention relates to a method of reducing or preventing occurrence of a seizure comprising cooling brain tissue at or near a seizure focus or a brain structure that modulates (e.g. causes or influences the occurrence of) seizures.

[0026] In another preferred embodiment, the invention relates to a method of reducing or preventing occurrence of a seizure comprising cooling brain tissue and electrically stimulating brain at or near a seizure focus or a brain structure that modulates seizures.

[0027] In yet another preferred embodiment, the invention relates to a method of reducing or preventing occurrence of a seizure comprising cooling brain tissue and infusing said medication into brain at or near a seizure focus or a brain structure that modulates seizures.

[0028] In still another preferred embodiment, the invention relates a method of reducing or preventing occurrence of a seizure comprising cooling brain tissue and electrically stimulating brain tissue and infusing a medication into brain at or near a seizure focus or a brain structure that modulates seizures. This structure might be near, part of, or remote from region or regions where seizure is originating.

[0033] In a preferred embodiment, seizures are reduced or prevented by electrically stimulating the brain at or near a seizure focus or a structure that might be near, part of, or remote from the region or regions where the seizure is originating and stimulation of which would result in inhibition, prevention, disruption or termination of the seizure.

[0037] The traditional methods of electrical stimulation for neuronal tissue always use symmetric waveforms to balance positive and negative electrical charge during stimulation. Charge balance also can be achieved with asymmetric pulses whose positive and negative phases have equal areas-under-the-curve, as is the case the Medtronic ITREL-II (Medtronic, Inc., Minneapolis, Minn., USA). Charge balance is needed to prevent damage due to gas generation and / or deposition of electrode material into the tissue. The device used according to the invention maintains charge balance by ensuring the product of current and pulse duration is the same for both positive and negative pulses, but allows for the pulses of one chosen polarity to be much larger than those of the opposite polarity. A direct consequence of this condition is that the high amplitude pulses are necessarily shorter than the opposite low amplitude pulses. This arrangement of high and low amplitude pulses is chosen so that only the high amplitude pulses have any significant effect, being above a physiological threshold. The low amplitude pulses would be below this threshold and so have no effect. The result, in theory, is a device that causes an effect with only one chosen polarity of current. This results in DC-like stimulation, without the damaging effects of DC current such as gas generation and electrode material deposition.

Problems solved by technology

Epilepsy is a significant medical problem, as nearly 1% of the United States population is affected by this disease at any given time, constituting about 2.6 million people.

Thus, the disorder is a significant health problem and a need exists for improved treatments to control the disease and alleviate its burden on society as a whole.

Information thus far indicates that it is moderately effective, but only rarely controls seizures completely.

Direct electrical stimulation has been applied to the cortex of humans for mapping purposes since the 1930s, but a complication of cortical stimulation can be the unwanted occurrence of afterdischarges.

However, if not synchronized to the repolarization wave, stimulus will induce cardiac fibrillation, since some parts of tissue are in process of recovery from previous depolarization and therefore will be susceptible to another depolarizing stimulus.

Decreased conduction velocity and increased wave duration “disperses” potentials that arrive more centrally, and this in turn result in a decrease in responsivity of spinal and cerebral neurons.

On the other hand, weakness of paramyotonia congenita increases with lower temperatures.

Therefore, although a number of detection methods have been tried, no one method has been entirely successful.

Moreover, many methods are computationally intensive, so that calculation using an implantable microchip is not feasible.

Historically, stimulation of inhibitory structures alone has not been particularly successful in seizure management.

The combination of drug infusion with brain stimulation as disclosed in Ward '923, however, would fail to be effective in many types of seizures.

Many drugs are not particularly stable at body temperature, rendering them unsuitable for long term storage in an implanted infusion device.

Certain risks exist for patients receiving combined therapy of Ward '923, including an increased risk for seizure propagation due brain stimulation as well as drug related side effects.

Thus, while suitable for controlling some seizures, a substantial population of patients have seizures which cannot be treated using the methodology of Ward '923.

U.S. Pat. No. 5,938,689 to Fischell discloses methods of electrode placement and configuration but does not disclose means of activity sensing or detection, or methods of brain stimulation.

However, predictions of seizure occurrence and the optimal timing and locality of treatment are not suitably provided for by Fischell '449.

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