Bronchial thermoplasty is a new bronchoscopic procedure from the team at PulmoGeniX intended for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists.

EXISTING PROCEDURE

Requires three outpatient visits

Expensive- requires a new probe for each visit

Time consuming- per visit treatment time is 1-2 hrs to treat 30-40 sites

Technically challenging- involves learning new bronchoscopic techniquesProbe must directly contact the treatment site to be effective, which limits the number and location of airways that can be treated

The drawbacks of Bronchial Thermoplasty are that the therapy requires at least three operative proceduresover 3 months. In addition to being a belabored, time consuming therapy the procedure is expensive, technically challenging for physicians and burdensome to the patient.

 
 

SOLUTION APPROACH

The PulmoGenix approach to Bronchial Smooth Muscle Modification is intended to be an objective, evidence based approach that affords the clinician the ability to identify a baseline measurement of the relative levels of spasticity of bronchial smooth muscle, diagnostically, prior to treatment. This proprietary device, known as the pulmotonometer™, enables the clinician to best discern the locations and degrees of spasmodic activity. The region is then chambered. This is accomplished by deploying two occlusion balloons at the distal and proximal ends of the airway segment. The chamber is then filled with an electrically conductive fluid.

Once the chamber is filled an RF and/or DC current, of specific frequency, is then applied to the region; creating an electrophoresis intended to modify the bronchial smooth muscle, uniformly and circumferentially, along the entire segment.

NOVEL ABLATION APPROACH

Bronchoscopic approach

Diagnostic intelligence before and after treatment with Pulmotonometer™

Therapeutic efficacy determined in real time

Device designs:

o   Utilize DC and or RF energy

o   Conductive fluid carries energy, extending treatment area

Allows treatment of larger areas in less time

Allows targeting of smaller, more distal airways

Non-thermal ablation may minimize mucosal damage

Therapy can be delivered safely, expeditiously and cost effectively in one procedure.

•        Used for severe asthma that doesn't improve with inhaled corticosteroids or other long-term asthma medications

•        Treatment performed through the working channel of a standard flexible bronchoscope

•        Involves heating the airways with an electrode, reducing the smooth muscle inside the airways

•        Limits the ability of the airways to tighten

Bronchial thermoplasty is performed through the working channel of a standard flexible bronchoscope that is introduced through a patient’s nose or mouth, and into their lungs. Under sedation, a catheter inside a bronchoscope—a thin, flexible tube-like instrument introduced through the patient’s nose or mouth, and into their lungs. The tip of the small diameter catheter is expanded to contact the walls of targeted airways. Controlled thermal energy is then delivered to the airway walls to reduce the presence of excess airway smooth muscle that narrows the airways in patients with asthma.

The catheter delivers a series of 10-second temperature controlled bursts of radio frequency energy, which heat the lining of the lungs to 65 degrees Celsius.  This heat destroys some of the muscle tissue that constricts during an asthma attack, reducing the number and severity of incidents. The patient is monitored after the procedure and usually returns home that day or early the next day.

In the period immediately following bronchial thermoplasty, the most common side effect is an expected transient increase in the frequency and worsening of respiratory-related symptoms, which are of the type expected following bronchoscopy in patients with asthma. These events typically occur within a day of the procedure and resolve on average within seven days with standard care.

THE NEW PULMOGENIX SOLUTION: SMOOTH MUSCLE MODIFICATION

PulmoGeniX™, in coordination with Mayo Clinic, is developing a comprehensive device based treatment intended to diagnose and treat asthma. The technology was invented to reduce bronchial smooth muscle to eliminate its ability to constrict and, thus, dramatically decrease asthma attacks. It is designed to treat a greater number of airways simultaneously, to be less technically challenging for the physician, to be performed within one procedural visit and to be less expensive for the patient.

After therapy is delivered, the electrically conductive fluid is withdrawn. The chamber is then filled with methyl choline. The methyl Choline is intended to incite an asthmatic spasm of the bronchial smooth muscle. The Pulmotonometer is then used to, once again, measure the relative levels of spasticity of the smooth muscle. This post therapy measurement is then compared to the pre-therapy diagnostic measurement to evaluate treatment efficacy.