Perineural Electrode for Sympathetic Chain Modulation

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Solution Overview

Problem

Current neural modulation techniques, such as spinal cord stimulation and dorsal root ganglia stimulation, fail to adequately address neuropathic pain as they do not effectively target slow-moving unmyelinated type C fibers, which require higher amplitude stimulation and can cause intolerable side effects when other neuronal elements are modulated.

Innovation Solution

The development of a sympathetic modulation therapy that targets the sympathetic chain in the lumbar region using electrical stimulation to modulate neural activity, employing higher amplitude and frequency ranges to effectively block pain signals and improve perfusion without side effects, utilizing novel electrode designs and surgical techniques for precise placement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If higher amplitude stimulation is delivered to target unmyelinated type C fibers, then pain signal coverage is improved, but intolerable side effects occur when other neuronal elements are modulated

Engineering Contradiction:
Improvepain signal coverageVSAvoidintolerable side effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies local quality by using a perineural electrode that wraps around the sympathetic chain to deliver stimulation locally at the target site, rather than delivering stimulation from the epidural space. This localized approach allows high amplitude stimulation to be applied specifically to the sympathetic chain and type C fibers without affecting other neuronal elements in the broader epidural space, thereby achieving reliable pain signal coverage without intolerable side effects.

Inventive Principle:
Principle #3Local quality

2Reliability

If conventional SCS or DRG stimulation is used, then other neuronal elements are modulated, but maximal coverage of type C fibers is not achieved

Engineering Contradiction:
Improvetype C fiber coverageVSAvoidmodulation of other neuronal elements
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts the stimulation target specifically to the sympathetic chain by using a perineural electrode that wraps around this structure. This extraction approach isolates the sympathetic chain as the primary target, enabling selective modulation of type C fibers associated with the sympathetic chain while minimizing or eliminating modulation of other neuronal elements such as dorsal column fibers that are targeted by conventional SCS or DRG stimulation.

Inventive Principle:
Principle #2Taking out (Extraction)

3Reliability

If sympathetic modulation therapy is used to target type C fibers, then pain relief and perfusion improvement are achieved, but precise placement and novel surgical techniques are required

Engineering Contradiction:
Improvetherapy effectivenessVSAvoidsurgical implantation complexity
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent applies preliminary action by performing a trial period with the perineural electrode implanted around the sympathetic chain before committing to permanent implantation. This trial period allows clinicians to assess therapy effectiveness and optimize stimulation parameters before final implantation, reducing the risk of unsuccessful procedures and improving overall therapeutic outcomes while managing surgical complexity.

Inventive Principle:
Principle #10Preliminary action

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 provides long-lasting pain relief and improved perfusion by effectively targeting type C fibers, reducing cardiac load and hypertension, and is reversible, unlike sympathectomy, with minimal side effects and improved patient outcomes.

Implementation Method 1

The modulation device is configured to deliver a modulation signal in the form of a train of electrical pulses to the one or more neural targets

Methodology Applied
Scientific EffectElectrical stimulation: Electrical Impedance Tomography

Data Source

PatentEP3393574B1Systems to provide sympathetic modulation therapy
Publication Date: 2022.10.12 BOSTON SCIENTIFIC SCIMED INC
  • EP3393574B1 patent drawingFigure 1~2
  • EP3393574B1 patent drawingFigure 3
  • EP3393574B1 patent drawingFigure 4

AI summary

An example of a system includes a lead including a distal electrode portion. The distal electrode portion is configured to at least partially encircle a sympathetic chain in a lumbar region or thoracic region. The distal electrode portion includes at least one electrode oriented toward the sympathetic chain when the distal electrode portion at least partially encircles the sympathetic chain. The distal portion includes at least one anchoring site configured for use to mechanically secure the distal electrode portion to tissue proximate to the sympathetic chain. The lead has a strain relief proximate to the distal electrode portion.