Neuro-Kinesis’ SMART-catheter™ takes the base functionality of catheters as minimally invasive in-vivo tools for a variety of surgical procedures such as fluid delivery and drainage, interior telemetry and mapping, and targeted ablation and biopsy, and brings the widely used device into the digital age by endowing it with advanced real-time biosensing feedback with signal resolution far beyond what is typically available.
Though electrode tipped catheters and signal translation equipment, which converts readings into visual maps, have become much more efficient and reliable, the existing catheter technology still has many core underlying problems which have proved to be limiting factors in the accuracy of catheter-based mapping.
The first being the ability to accurately measure and interpret the electrical signals within the human body into reliable images and data a physician requires during a given procedure. The signals a catheter must measure only range in the zero to 200 millivolt range, or 1/10,000 of the electrical current that runs through the average U.S. electrical plug. Developing a sensing technology that is capable of accurately measuring this extremely low voltage and its related impedance or bioelectric potential consistently, accurately, and repeatedly as it traverses a target site has continued to limit the traditional catheter as being as effective as it can be.
The second problem is the ability to trust the fidelity of the information captured in the electrical signals being gathered. Data points being measured are calculated based on the difference between the voltage the electrode emits and the resistance of that signal by the cell, tissue, or organ it is measuring. Since this voltage is so small, there are many variables that can affect the results that the sensor reads. In essence, the catheter must be able to distinguish a specific electrical signal or “sound” from all the other noise around it. Because the amplitude of the energy that a catheter uses is so low and the ambient noise of the surrounding body can be constant and overpowering, the ability for the catheter to pick out the relevant signals the physician is looking for and dismissing the rest has proved an ongoing challenge.
The SMART-catheter™ seeks to solve both of these issues and provide a quantum leap forward in catheter-based EP electrode technology.
In order to eliminate the problems associated with providing clean, uninterrupted power and signal fidelity to the catheter tip, the engineering team has moved the power amplifier from the end of the catheter and miniaturized it to be embedded in the catheter electrode tip. Since the signal no longer has to travel several feet, which at the low-current used in catheter-based mapping can cause severe signal degradation, the sensing electrode now has a constant, clean power supply signal to work with.
Additionally the SMART-catheter™ incorporates a patented sensor array at its tip that is much more efficient at distinguishing relevant data from extraneous noise.
Next, the SMART-catheter™ has a digital processing system built into the tip method for interpreting the captured data at the sensor point instead of the post signal processing which is done today.
Finally, the SMART-catheter™ has a proprietary analog to digital converter at the electrode tip in order to change the data results going back to the physician from an RF analog signal to a high-quality digital signal that is able to keep its fidelity intact on the journey back to the physician’s diagnostic display equipment.
- source-point signal amplifier to eliminate signal degradation.
- advanced sensor array to provide enhanced signal/noise reduction.
- source-point data analysis.
- proprietary post-analysis analog to digital conversion provides high-resolution signal transfer back to the physician.
- multiple configurations including:
• Bipolar catheter with irrigation
• Quadrapolar catheter with
• Balloon catheters
• Spiral catheter
- Cardiac mapping and ablation.
- Vital organ mapping for renal, gastrointestinal, and cerebral visualization.
- Renal Denervation for the treatment of hypertension.
- ICD leads for the regulation of heart rhythms.
- Neuromodulation for the treatment of:
- Parkinson’s disease
- Essential tremors
- Primary dystonia
- Chronic intractable pain
- Failed Back Surgery Syndrome
- Complex Regional Pain Syndrome
- Peripheral vascular disease
- Intractable angina pectoris
- Future uses are seen for treating epilepsy, seizure disorder, and forms of dementia.