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Patent of the Month – Nerve Stimulation Method

Patent of the Month –  Nerve Stimulation Method

| On 28, Sep 2019

Darrell Mann

Our patent of the month this month takes us to the New Jersey-based enterprise, Electrocore LLC. US10,252,074 was granted to a trio of inventors at the company on 10 April. The company has been around and offering non-invasive nerve stimulation therapies for over 15 years now, but this new patent sounds like a significant step forward. Despite the fact that the application has been in the USPTO system being debated since 2012. Here’s what it has to say about their business and the problem requiring to be solved:

The field of the present invention relates to the delivery of energy impulses (and/or fields) to bodily tissues for prophylactic purposes. It relates more specifically to the use of non-invasive devices and methods for transcutaneous electrical nerve stimulation and magnetic nerve stimulation, along with methods for averting imminent medical disorders using energy that is delivered by such devices. The disorders comprise the following medical problems: asthma attacks and COPD exacerbations, epileptic seizures, migraine or other headaches having sudden onset, ventricular fibrillation/tachycardia, myocardial infarction, transient ischemic attacks or strokes, atrial fibrillation, panic attacks and attacks of depression.

The use of electrical stimulation for treatment of medical conditions has been well known in the art for nearly two thousand years. It has been recognized that electrical stimulation of the brain and/or the peripheral nervous system and/or direct stimulation of the malfunctioning tissue holds significant promise for the treatment of many ailments, because such stimulation is generally a wholly reversible and non-destructive treatment.

Many therapeutic applications of electrical stimulation involve the surgical implantation of electrodes within a patient. In contrast, devices used for the medical procedures that are disclosed here stimulate nerves by transmitting energy to nerves and tissue non-invasively. They may offer the patient an alternative that does not involve surgery. A medical procedure is defined as being non-invasive when no break in the skin (or other surface of the body, such as a wound bed) is created through use of the method, and when there is no contact with an internal body cavity beyond a body orifice (e.g., beyond the mouth or beyond the external auditory meatus of the ear). Such non-invasive procedures are distinguished from invasive procedures (including minimally invasive procedures) in that invasive procedures do involve inserting a substance or device into or through the skin or into an internal body cavity beyond a body orifice.

Potential advantages of non-invasive medical methods and devices relative to comparable invasive procedures are as follows. The patient may be more psychologically prepared to experience a procedure that is non-invasive and may therefore be more cooperative, resulting in a better outcome. Non-invasive procedures may avoid damage of biological tissues, such as that due to bleeding, infection, skin or internal organ injury, blood vessel injury, and vein or lung blood clotting. Non-invasive procedures generally present fewer problems with biocompatibility. In cases involving the attachment of electrodes, non-invasive methods have less of a tendency for breakage of leads, and the electrodes can be easily repositioned if necessary. Non-invasive methods are sometimes painless or only minimally painful and may be performed without the need for even local anesthesia. Less training may be required for use of non-invasive procedures by medical professionals. In view of the reduced risk ordinarily associated with non-invasive procedures, some such procedures may be suitable for use by the patient or family members at home or by first-responders at home or at a workplace, and the cost of non-invasive procedures may be reduced relative to comparable invasive procedures.

Despite its attractiveness, non-invasive electrical stimulation of a nerve is not always possible or practical. This is primarily because the stimulators may not be able to stimulate a deep nerve selectively or without producing excessive pain, because the stimulation may unintentionally stimulate nerves other than the nerve of interest, including nerves that cause pain. Accordingly, there remains a long-felt but unsolved need to stimulate nerves totally non-invasively, selectively, and essentially without producing pain.

So, in crude terms, what we have here is a collateral damage problem, the key word in the last sentence being ‘selectively’, i.e. we want to stimulate the right nerve and avoid stimulating all the other things around it. Here’s how we might map that problem onto the Contradiction Matrix:

And here’s the first two Claims of the patent, describing the main inventive steps:

    1. A method of averting an onset of an acute medical event in a patient, the method comprising: detecting a signal via a sensor [Principle 23] , wherein the signal is at least one of physiological or environmental, wherein the signal is at least one of within, on, or about the patient, wherein the signal includes a value; forecasting [Principle 10] the onset of the acute medical event based at least in part on the value; positioning a contact surface of a housing against an outer skin surface of a neck of the patient, wherein an electrical impulse generator [Principle 28] is positioned within the housing and wherein the contact surface is integral with the housing; generating an electrical impulse with the electrical impulse generator; and transmitting, via the electrical impulse generator, based at least in part on the forecasting, the electrical impulse non-invasively and transcutaneously through the outer skin surface of the neck of the patient to a selected nerve fiber in the patient to treat the acute medical event, wherein the electrical impulse is sufficient to avert the acute medical event, wherein the acute medical event is selected [Principle 1] from a group of events comprising an asthma attack, an epileptic seizure, an attack of migraine headache, a transient ischemic attack, an onset of atrial fibrillation, a myocardial infarction, an onset of ventricular fibrillation or tachycardia, a panic attack, and an attack of acute depression. 
    2. The method of claim 1, further comprising: generating a shaped [Principle 15] electrical impulse within the housing; and wherein the transmitting comprises transmitting the shaped electrical impulse to the patient through a conducting medium positioned within the housing.

Put in lay-person terms, the invention solves the contradiction by anticipating the onset of a medical problem such that a profiled nerve stimulation algorithm can be selected and then transmitted to the relevant (vagus) nerve to cut off full onset of that problem. Kind of like, ‘in forty minutes it looks like you’re going to have a migraine, press this against your neck and press the button now to stop it from happening’.