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Non-harmful peripheral pain stimulation

Addressing patient injury caused by frequent consciousness assessments in the Neuro-ICU.

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Background

In the realm of neurocritical care, where patients are often fighting for their lives following traumatic brain injuries, strokes, or other serious conditions, the assessment of consciousness is a crucial part of their treatment and prognosis. Neurologists, nurses, and other healthcare providers rely on frequent neurological exams to determine the level of consciousness in these patients. However, the current methods employed in these assessments, particularly those involving noxious stimuli, can cause significant harm to patients, leading to complications, extended hospital stays, and strained relationships between caregivers and patients' families.

The Typical Process

When a patient is admitted to the Neuro-ICU, a non-injurious neurologic exam is performed, in which a clinician assesses factors like eye movement, speaking patterns, and reflexes to better understand the ever-changing state of the patient's nervous system. If the patient is responsive, the clinician will develop a patient-specific treatment plan, following from the results of the exam. However, if the patient is not responsive, a more comprehensive assessment of consciousness is required.

The primary goal of this consciousness assessment is to observe how a patient reacts to external stimuli. A clinician will typically start with a mild noxious stimulus, such as a light pinch on the arm or a firm press on the nail bed, in order to trigger an involuntary motor response. If the patient is still unresponsive, the clinician will move forward with increasingly painful stimuli — potentially culminating in pinching the patient's tricep with as much force as possible, smashing the patient's fingernails, or administering an often damaging sternal rub. The patient's response (or lack thereof) to these stimuli provides insight into the state of the patient's consciousness, which is notoriously difficult to measure non-invasively.

The Problem

Unfortunately, the exams don't stop there. Neuro-ICUs have varying protocols, but for all of them, this consciousness assessment is administered by a doctor, registered nurse, or nurse practitioner frequently throughout a patient's stay. When our team shadowed at the JHMI Neuro-ICU, we discovered these exams were typically administered by nurses during their rounds once an hour. For stroke patients, they are administered once every fifteen minutes. The frequency of these exams, in combination with their physically harmful nature, can lead to an accumulation of bruises and cuts. It can be particularly distressing for families to see their loved ones sustain new injuries throughout the duration of their stay.

Core Issues

After hundreds of hours of literature review, shadowing in the Neuro-ICU, and interviews with clinicians, our team has identified the following three core issues:

Long Term Damage

Patients in the Neuro-ICU with disorders of consciousness (DOC) require assessments up to every hour to determine their level of consciousness and further treatment. Frequent and increased noxious stimuli during current consciousness-testing often leads to Local Skin Response 1 (LSR1). LSR1 refers to mild skin irritation in the form of bruising, swelling, and irritation and can often lead to increased hospital stays.

Lack of Standardization

Another issue with this consciousness assessment is the wide variation in pain stimulus application among clinicians. To investigate, our team set up a small force sensor in the Neuro-ICU and surveyed 20-30 clinicians, including neurosurgeons, neurointensivists, and nurses. We asked them to simulate the force they’d use at different exam points, revealing a nearly 500% difference between the weakest and strongest pinches. This preliminary study underscored the significant inconsistencies in the current noxious stimulus protocol, which can compromise the quality of care and impact critical treatment decisions.

Distrust in Physicians

The visible bruising and skin irritation leaves patient loved ones with a poor perception of care and loss of trust in their healthcare professionals.

Our Solution

The Thermal Grill Illusion

The thermal grill illusion is a sensory illusion that occurs when multiple warm and cool surfaces make contact with human skin in close proximity – although the surfaces are not warm or cool enough to damage your skin, your brain processes the heat gradient as an intense burning sensation, resulting in a very effective pain stimulus.

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Our Device

Our device takes advantage of the thermal grill illusion to create a sensation of pain that is physically harmless. The device consists of:

  • An on-off button
  • A light to signal the device is ready for use
  • A disposable patient interface
  • An ergonomic handle

The device itself utilizes peltier elements to produce the burning sensation, a metal interface to transfer heat, a heat sink to maximize heat dissipation, and a printed circuit board for control. By maintaining the ideal 20 degree temperature gradient, our device maximizes the burning sensation without causing the patients any physical damage.

We will be the first device on the market to provide a non-harmful, controllable, and standardized pain stimulus, eliminating patient injury and providing physicians with a consistent basis for decision-making.

Key Features

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Multiple Intensity Levels

Our final device will feature multiple stimulation intensities, allowing caregivers to perform consistent standardized consciousness assessments

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Portability

Our device is small, portable and battery powered, making it easy to use one device for multiple patients.

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Disposable Patient Interface

Disposable, sanitizable patient interfaces simplify cleaning procedures and allow for a quick setup.

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Ergonomic grip

Our easy-to-grip device makes it easy to apply pain stimuli wherever needed.

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Precise Temperature Control

Precise Temperature Control ensures stimuli are standardized and kept within a safe limit for patients. An emergency failsafe shuts off the device at dangerous temperatures.

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Simple User Interface

Our simplified user interface ensures our device is easy to learn how to use, allowing providers to immediately adopt our technology with minimal disruption to their workflow.

Timeline

A brief history of our organization's history and upcoming milestones

Spring 2023
Design Team founded in the Johns Hopkins Department of Biomedical Engineering
Summer 2023
Matched with critical mentors Dr. Adam Schiavi and Geoffrey Miller, began investigating patient harm in the Neuro-ICU
Fall 2023
Shadowed extensively in the Neuro-ICU, interviewed dozens of clinicians & developed a base of background research
Spring 2024
Built our first prototype (proof of concept) to demonstrate the viability of our solution
Summer 2024
Founded B9 Stimulus Technologies LLC, filed for IP & submitted application to IRB
Fall 2024
We have begun development of our minimum viable product –  a self-contained, battery-powered device equipped with safety measures and a user interface.
2025
We aim to initiate Clinical Trials and refine our prototype.
2026
We will seek approval by the FDA for our device and begin Design-for-Manufacture.
2027+
We hope to launch our product and expand across hospitals around the world.