Laparoscopic Sizing Instrument with Magnetic Adjustable Loop

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Solution Overview

Problem

Current methods for treating anatomical lumens, such as the esophagus, often fail to provide effective sphincter augmentation, leading to inadequate regulation of food and acid reflux, as they lack a precise sizing mechanism to accommodate varying diameters of the lower esophageal sphincter, potentially resulting in improper implant length and subsequent complications like dysphagia or tissue erosion.

Innovation Solution

A laparoscopic sizing instrument with an auto-tensioning feature that includes a handle assembly, shaft assembly, and end effector, featuring a flexible member with magnetic coupling elements to form an adjustable loop, allowing for accurate measurement and engagement with the esophageal sphincter, preventing over- or under-engagement and ensuring proper implant sizing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a fixed-size implant is used for sphincter augmentation, then the device structure is simple, but it cannot accommodate varying diameters of the lower esophageal sphincter, leading to improper sizing

Engineering Contradiction:
Improveadaptability to varying sphincter diametersVSAvoiddevice structure complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The implant device incorporates a flexible member that can dynamically adjust its configuration between compressed and expanded states. The flexible member includes coupling elements that can be positioned at different locations along its length, allowing the implant to adapt to varying sphincter diameters while maintaining a relatively simple overall device structure.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The flexible member is divided into multiple segments or sections with coupling elements that can be independently positioned. This segmentation allows different portions of the implant to be adjusted to match the specific geometry of the patient's sphincter, providing adaptability without requiring a completely complex device architecture.

Inventive Principle:
Principle #1Segmentation

2Measurement precision

If manual measurement methods are used for sphincter sizing, then the device is simple, but measurement precision is insufficient, potentially resulting in improper implant length

Engineering Contradiction:
Improvesphincter diameter measurement precisionVSAvoidsizing mechanism complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces manual mechanical measurement methods with a magnetic field-based measurement system. Magnetic coupling elements are used to non-invasively measure the dimensions of the lower esophageal sphincter, providing precise measurements without requiring complex mechanical measurement devices or manual probing procedures.

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

Solution Approach 2:

Magnetic fields serve as an intermediary between the measurement device and the sphincter tissue. The magnetic coupling elements interact with the sphincter anatomy through the magnetic field, enabling indirect but precise measurement of sphincter dimensions without direct mechanical contact that could distort the measurement.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If the implant is engaged without precise sizing, then the procedure is quick and simple, but complications like dysphagia or tissue erosion may occur

Engineering Contradiction:
Improveprocedure safety and reliabilityVSAvoidsizing and engagement mechanism complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent performs preliminary measurement and sizing of the lower esophageal sphincter before implant engagement. The magnetic coupling elements are used to measure sphincter dimensions in advance, allowing the implant to be properly sized and configured before deployment, thereby preventing complications while maintaining a manageable procedural complexity.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The measurement system provides feedback on sphincter dimensions to guide the implant sizing and engagement process. This feedback mechanism ensures that the implant is appropriately sized for the patient's specific anatomy, improving procedural safety and reliability without requiring overly complex engagement mechanisms.

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

The instrument enables precise measurement and engagement with the esophageal sphincter, ensuring the correct implant size is used, thereby effectively preventing reflux and minimizing complications like dysphagia or tissue erosion, while maintaining proper sphincter function.

Implementation Method 1

The first and second coupling elements are biased toward each other such that the flexible member defines an adjustable loop

Methodology Applied
Scientific EffectMagnetic attraction: Magnetism

Data Source

PatentUS12016591B2Laparoscopic sizing instrument
Publication Date: 2024.06.25 CILAG GMBH INTERNATIONAL
  • US12016591B2 patent drawing
  • US12016591B2 patent drawing
  • US12016591B2 patent drawing

AI summary

An apparatus includes a handle assembly, a shaft assembly, an end effector, and an auto-tensioning feature. The handle assembly includes a body and a plunger. The shaft assembly includes an external sheath that is fixed to the handle body and an interior shaft that is coupled to the plunger. The interior shaft is slidable relative to the external sheath. The end effector is configured to encompass a bodily lumen and includes a flexible member extending distally from the interior shaft. A first coupling element is fixed to the distal tip of the flexible member. A second coupling element is fixed to the external sheath. The first and second coupling elements are magnetically attracted to each other and are biased toward each other such that the flexible member defines an adjustable loop. The auto-tensioning feature is configured to bias the plunger portion proximally relative to the handle body.