Navigating Introducer with Conical Tip for Brain Tissue Access

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Solution Overview

Problem

Current navigational systems for brain surgery lack the capability to provide effective minimally invasive access while maintaining navigational information during the positioning of access systems, leading to potential trauma and complications due to the complexity and delicacy of brain tissue.

Innovation Solution

A surgical access system comprising an introducer with a conical distal tip and a navigational stylet, designed to atraumatically dilate and navigate through brain tissue, minimizing damage by using a radiused tip and a locking mechanism for precise alignment, allowing for flexible diameter and length options and integration with imaging systems for real-time navigation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If traditional surgical access methods are used to reach deep brain structures, then access to the target area is achieved, but trauma to brain tissue and risk of damaging eloquent structures increases

Engineering Contradiction:
Improvetrauma to brain tissueVSAvoidaccess path length
Core Design Contradiction:
Object-affected harmful factorsVSLength of moving object

Solution Approach 1:

The surgical access system is divided into multiple components: an introducer with conical distal tip for initial penetration, a stylet for navigation and support, and an outer sheath for protection. This segmentation allows each component to be optimized for its specific function, enabling minimally invasive access to deep brain structures while reducing trauma to eloquent tissue.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The introducer features a conical distal tip with a radiused surface that transitions smoothly from the cylindrical body. This curved, conical geometry allows the introducer to atraumatically dilate tissue as it advances, reducing mechanical trauma to brain tissue while maintaining the ability to reach deep targets.

Inventive Principle:
Principle #14Spheroidality (Curvature)

2Object-affected harmful factors

If minimally invasive access techniques are used, then trauma to brain tissue is reduced, but navigational information during positioning becomes insufficient

Engineering Contradiction:
Improvetrauma to brain tissueVSAvoidnavigational information
Core Design Contradiction:
Object-affected harmful factorsVSLoss of information

Solution Approach 1:

The stylet acts as an intermediary element that bridges the introducer and the target brain structure. It provides continuous navigational information during positioning through its interaction with imaging systems, while the introducer maintains minimal trauma to surrounding eloquent tissue. The stylet's presence allows real-time tracking without requiring the larger introducer to be fully inserted.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

Traditional mechanical navigation methods are replaced by integrating the stylet and introducer with imaging systems for real-time tracking. This substitution provides continuous navigational information during the minimally invasive procedure, allowing the surgeon to maintain precise positioning without increasing trauma to brain tissue.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Measurement precision

If a rigid introducer is used for stable positioning, then navigational accuracy is improved, but trauma to delicate brain tissue increases

Engineering Contradiction:
Improvenavigational accuracyVSAvoidtrauma to brain tissue
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The introducer exhibits local quality variations: the distal tip is conical with a radiused surface for atraumatic tissue dilation, while the proximal portion is cylindrical and rigid for stable positioning and accurate navigation. This localized differentiation allows the introducer to provide navigational accuracy where needed while minimizing trauma at the tissue interface.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The introducer's geometry changes along its length, transitioning from a rigid cylindrical body to a conical distal tip with a radiused surface. This parameter change in shape allows the introducer to maintain rigidity for accurate navigation while the conical tip provides atraumatic access to deep brain structures.

Inventive Principle:
Principle #35Parameter changes

4Adaptability or versatility

If the introducer diameter is increased to accommodate larger instruments, then instrument versatility is improved, but trauma to brain tissue and difficulty of insertion increases

Engineering Contradiction:
Improveinstrument compatibilityVSAvoidtrauma to brain tissue
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The stylet is nested within the introducer, and the introducer is inserted through the outer sheath. This nested configuration allows the system to maintain a small external profile for minimally invasive insertion while accommodating various instrument sizes within the introducer lumen, providing versatility without increasing trauma to brain tissue.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The system allows for dynamic adjustment of instrument configuration. The stylet can be advanced or retracted within the introducer, and different instruments can be exchanged within the same introducer lumen. This dynamic flexibility provides instrument versatility while maintaining a consistent, minimally invasive introducer diameter.

Inventive Principle:
Principle #15Dynamics

Data Source

PatentUS20200015845A1Navigating introducer for tissue access system
Publication Date: 2020.01.16 STRYKER CORP
  • US20200015845A1 patent drawing
  • US20200015845A1 patent drawing
  • US20200015845A1 patent drawing

AI summary

A surgical access system is disclosed that includes an outer sheath, an introducer, and a navigational stylet. The outer sheath is defined by an open distal end and an open proximal end and includes a hollow body portion therebetween. The obturator is defined by a distal end and a proximal end. The distal end further comprises a tapered distal tip member that terminates in a distal tip. The navigational stylet is configured to be selectively fixed to the obturator and is configured to indicate the location of the obturator within a patient during use. The obturator is configured to be received within the outer sheath such that the tapered distal tip member protrudes from the open distal end of the outer sheath when the obturator is in an introducing configuration.