Catheter Transducer for Real-Time Nerve Denervation Feedback

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Solution Overview

Problem

Current renal nerve ablation procedures lack a feedback mechanism to assess the destruction of nerve activity, leading to inefficiencies due to poor probe/tissue interface and inadequate targeting of nerves, resulting in variable clinical responses and uncertainty about the success of the procedure.

Innovation Solution

A catheter system with integrated electrodes and a transducer that emits controlled amounts of energy to heat nerves, allowing for the sensing of neural responses before and after ablation, enabling real-time feedback on the extent of nerve denervation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If destructive means are delivered to renal nerves using a catheter, then nerve activity is reduced or abolished, but there is no feedback mechanism to assess whether the desired destruction has been accomplished

Engineering Contradiction:

Improvesuccess of nerve ablationVSAvoidfeedback on nerve destruction

Core Design Contradiction:

ReliabilityVSLoss of information

Solution Approach 1:

The patent applies feedback by using electrodes to detect neural activity before and after ablation. The system delivers destructive energy to renal nerves and then uses the same or separate electrodes to measure whether the nerves have been successfully ablated by detecting changes in neural activity signals, providing real-time feedback on treatment effectiveness

Inventive Principle:

Principle #23Feedback

2Ease of operation

If a probe is inserted into the body to deliver destructive means to nerves, then nerve function can be modulated, but there is poor probe/tissue interface and inadequate targeting of nerves

Engineering Contradiction:

Improveprobe/tissue interfaceVSAvoidtargeting of nerves

Core Design Contradiction:

Ease of operationVSManufacturing precision

Solution Approach 1:

The patent replaces mechanical targeting methods with electrical field-based localization. Electrodes detect neural activity signals to precisely identify nerve locations and map their distribution around the catheter, enabling accurate targeting without relying solely on mechanical probe positioning or visual inspection

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Object-affected harmful factors

If insufficient quantities of destructive means are delivered to nerve fibers, then the procedure is safe, but nervous activity is not sufficiently reduced or abolished

Engineering Contradiction:

Improvedamage to surrounding tissueVSAvoideffectiveness of nerve ablation

Core Design Contradiction:

Object-affected harmful factorsVSProductivity

Solution Approach 1:

The system uses feedback from neural activity detection to control the ablation process. By monitoring changes in neural signals during and after energy delivery, the system determines when sufficient ablation has been achieved, allowing optimization of energy delivery to ensure complete nerve destruction while minimizing damage to surrounding healthy tissue

Inventive Principle:

Principle #23Feedback

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This approach allows for precise and real-time monitoring of nerve denervation, improving the accuracy and effectiveness of renal nerve ablation procedures by ensuring sufficient energy delivery and confirming the integrity of nerve fiber destruction.

Implementation Method 1

energizing the transducer of the catheter to emit a first instance of a first amount of energy that is sufficient to heat the nerves in the tissue surrounding the biological lumen to an extent that a neural response is evoked without denervating the nerves

Methodology Applied

Scientific EffectHeating: Heating

Implementation Method 2

energizing the transducer of the catheter to emit a first instance of a second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen

Methodology Applied

Scientific EffectHeating: Heating

Data Source

PatentUS20230389852A1Methods, devices and systems that use one or more transducers to heat nerves to evoke neural response without denervating nerves, as well as to denervate nerves

Publication Date: 2023.12.07 OTSUKA MEDICAL DEVICES

AI summary

Certain methods and systems described herein use a transducer used to produce ablation energy (aka denervation energy) to also evoke a neural response before and/or after denervation energy is delivered. Rather than the neural response being invoked in response to electrical stimulus, it is invoked in response to the transducer (e.g., RF, microwave, or ultrasound transducer) being used to sufficiently heat the nerves in tissue surrounding a biological lumen to an extent that a neural response is evoked without denervating the nerves. That is, the transducer used for performing ablation (aka denervation) is also used to evoke a neural response prior to (and/or after) ablation is performed, by using the transducer to sufficiently heat the nerves in the tissue surrounding the biological lumen to an extent that a neural response is evoked without denervating the nerves. This can reduce the catheter production complexity and costs. Other embodiments are also disclosed.