Steerable Introducer Device for Biopsy Precision

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Solution Overview

Problem

Existing biopsy devices lack maneuverability and precision, especially in accessing soft tissue lesions within complex anatomical locations, due to their rigid design, which complicates accurate insertion and sampling during biopsy procedures.

Innovation Solution

A steerable introducer device with a handle, first and second conduits, and an actuating mechanism that allows for articulation and precision control, enabling the device to navigate through the body and accurately target lesions by translating and rotating components to achieve a semi-rigid distal end for precise insertion and biopsy sampling.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If a rigid design is used for biopsy devices, then structural stability is maintained, but maneuverability and precision in accessing complex anatomical locations deteriorates

Engineering Contradiction:
Improvestructural stabilityVSAvoidmaneuverability
Core Design Contradiction:
Stability of the object's compositionVSEase of operation

Solution Approach 1:

The introducer device is divided into multiple segments including a proximal segment, a distal segment, and a translating portion that can move relative to each other. This segmentation allows the device to maintain structural stability in each segment while enabling maneuverability through relative movement between segments, resolving the contradiction between rigidity and flexibility.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device incorporates a translating portion that can dynamically change its position and orientation relative to the conduits through actuation. This dynamic capability allows the device to adapt its configuration during insertion to access complex anatomical locations while maintaining overall structural integrity, thus improving maneuverability without sacrificing structural stability.

Inventive Principle:
Principle #15Dynamics

2Ease of manufacture

If a rigid design is used for biopsy devices, then manufacturing simplicity is maintained, but precision in targeting lesions deteriorates

Engineering Contradiction:
Improvemanufacturing simplicityVSAvoidtargeting precision
Core Design Contradiction:
Ease of manufactureVSManufacturing precision

Solution Approach 1:

By dividing the device into separate manageable segments (proximal conduit, distal conduit, translating portion), each component can be manufactured using standard techniques with controlled precision. The modular nature simplifies manufacturing while the precise assembly and actuation mechanisms enable accurate lesion targeting, resolving the contradiction between manufacturing simplicity and targeting precision.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device replaces complex rigid mechanical positioning systems with a more manufacturable actuation system that uses controlled translation and rotation of the distal segment. This substitution maintains manufacturing feasibility while achieving superior targeting precision through controlled articulation and positioning mechanisms.

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

3Ease of operation

If articulation mechanisms are added to improve maneuverability, then ease of operation improves, but device complexity increases

Engineering Contradiction:
ImprovemaneuverabilityVSAvoiddevice complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The articulation mechanism is segmented into discrete controllable portions, with the distal segment able to translate and rotate relative to the proximal segment. This segmentation allows for controlled maneuverability improvements while keeping each component relatively simple, thus improving ease of operation without proportionally increasing overall device complexity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device incorporates dynamic articulation capabilities that allow the distal segment to move relative to the proximal segment during insertion. This dynamic feature improves maneuverability and ease of operation in accessing complex anatomical locations while the movement is controlled through relatively simple actuation mechanisms, thus not excessively increasing device complexity.

Inventive Principle:
Principle #15Dynamics

Data Source

PatentUS20240293149A1Steerable introducer devices, systems, and methods
Publication Date: 2024.09.05 MERIT MEDICAL SYSTEMS INC
  • US20240293149A1 patent drawing
  • US20240293149A1 patent drawing
  • US20240293149A1 patent drawing

AI summary

Embodiments of a steerable device, and methods for using said device, for introducing medical devices into a patient's body is disclosed. The device may be inserted into a patient's body in a linear configuration, transitioned into an articulated configuration and then used to traverse to a precise location. The device may be articulated into a variety of configurations via an actuation portion of the handle.