Directional Dilation System with Neural Mapping

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Solution Overview

Problem

Current sequential dilation systems often cause tissue damage and trauma during surgical procedures, particularly when accessing the spine, as they do not effectively avoid neural elements or nerves, leading to potential damage during the dilation process.

Innovation Solution

A directional dilation system that uses a stimulating probe to map neural elements or nerves, allowing for safe zone identification and directional dilators to dilate tissue away from these elements, minimizing tissue separation and damage, while maintaining the psoas muscle intact on one side of the probe.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional sequential dilation systems are used to gradually increase incision size, then patient recovery time is reduced and tissue trauma is minimized, but neural elements or nerves cannot be effectively avoided leading to potential nerve damage

Engineering Contradiction:
Improvesafety of neural elementsVSAvoiddilation system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines the stimulation probe and directional dilator into a single integrated device. The stimulation probe is inserted through the dilator, allowing simultaneous neural mapping and directional tissue dilation. This merging eliminates the need for separate procedures to map nerves and then dilate, providing real-time feedback during dilation to avoid neural elements while maintaining procedural efficiency.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The stimulation probe acts as an intermediary between the surgeon and the neural elements. By providing real-time electrical stimulation feedback, it mediates the interaction between the dilation process and sensitive neural structures, allowing the surgeon to identify safe zones and adjust the dilation direction to avoid nerve damage.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If directional dilators are used to separate tissue on one side of the stimulating probe, then neural elements are protected from damage, but the device complexity and procedural steps increase

Engineering Contradiction:
Improvetissue damageVSAvoidprocedural simplicity
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The stimulation probe is inserted first to map the neural elements and identify safe zones before dilation begins. This preliminary action of neural mapping allows the surgeon to plan the dilation path in advance, knowing where neural structures are located. The directional dilator is then oriented based on this pre-established safety information, separating tissue away from identified nerves.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The directional dilator is designed to separate tissue selectively on one side of the stimulation probe while leaving the other side intact. This local quality approach allows targeted tissue separation in the direction away from neural elements, preserving healthy tissue on the opposite side where nerves may be located, rather than separating tissue uniformly in all directions.

Inventive Principle:
Principle #3Local quality

3Reliability

If the stimulation probe is used to map neural elements and define safe zones, then nerve damage is prevented, but the time required for neural mapping increases the overall procedure time

Engineering Contradiction:
Improveneural element protectionVSAvoidprocedure time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The stimulation probe remains in place throughout the entire dilation process, providing continuous neural mapping and real-time feedback. Rather than completing neural mapping as a separate preliminary step and then removing the probe, the probe stays positioned to continuously monitor and guide the dilation process, ensuring neural protection is maintained throughout without requiring additional time for separate mapping procedures.

Inventive Principle:
Principle #20Continuity of useful action

Data Source

PatentUS11737743B2Dilation system and method of using the same
Publication Date: 2023.08.29 DEPUY SYNTHES PROD INC
  • US11737743B2 patent drawing
  • US11737743B2 patent drawing
  • US11737743B2 patent drawing

AI summary

A method of forming an access opening through a psoas muscle to a patient's spine includes laterally inserting a stimulating dilator into the psoas muscle. The stimulating dilator has a stimulation channel formed in an outer surface thereof. An electrical pulse is transmitted into the stimulating dilator to locate a position of a nerve in the patient's psoas muscle. The stimulating dilator is laterally inserted through the psoas muscle and toward the patient's spine in a way that avoids the nerve. A stimulating probe is inserted into the stimulation channel along the outer surface of the stimulating dilator while transmitting an electrical pulse into the stimulating probe to verify the position of the nerve.