End Cap and Electrode Integration for Tissue-Layer Resection

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Solution Overview

Problem

Existing medical procedures face challenges in efficiently and safely treating tissue layers, such as the gastrointestinal tract, due to issues like increased duration, cost, and risk associated with tissue interference during procedures like Endoscopic Mucosal Resection (EMR), Endoscopic Sub-mucosal Resection (ESR), and Endoscopic Sub-mucosal Dissection (ESD), where positioning and manipulating tissue layers can be cumbersome and require multiple tools or devices.

Innovation Solution

A medical system comprising an insertion device with a working channel, a medical device with a movable electrode, and an end cap that allows for simultaneous delivery of energy and fluid, as well as tissue manipulation, without the need to switch tools, by using an electrode that is extendable and retractable, and an end cap that lifts or urges treated tissue away from the treatment site.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If multiple tools or devices are used for positioning and manipulating tissue layers, then the procedure can be performed, but the procedure duration and complexity increase

Engineering Contradiction:
Improveprocedure safetyVSAvoidprocedure duration
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent combines multiple functions (energy delivery, fluid delivery, and tissue manipulation) into a single integrated medical device. The device includes an electrode for energy delivery, a fluid delivery system with lumens, and a manipulator arm for tissue handling, all integrated into one unit that can perform multiple operations without requiring tool exchanges or multiple separate devices.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The medical device is designed as a universal tool that can perform multiple functions: delivering electrical energy via the electrode, injecting fluids through the fluid delivery lumen, and manipulating tissue using the manipulator arm. This multi-functional design eliminates the need for multiple specialized tools, thereby reducing procedure duration and complexity while maintaining safety.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Reliability

If multiple tools or devices are used for positioning and manipulating tissue layers, then the procedure can be performed, but the device complexity increases

Engineering Contradiction:
Improveprocedure safetyVSAvoidprocedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines multiple functions (energy delivery, fluid delivery, and tissue manipulation) into a single integrated medical device. The device includes an electrode for energy delivery, a fluid delivery system with lumens, and a manipulator arm for tissue handling, all integrated into one unit that can perform multiple operations without requiring tool exchanges or multiple separate devices.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The medical device is designed as a universal tool that can perform multiple functions: delivering electrical energy via the electrode, injecting fluids through the fluid delivery lumen, and manipulating tissue using the manipulator arm. This multi-functional design eliminates the need for multiple specialized tools, thereby reducing procedure duration and complexity while maintaining safety.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Productivity

If tissue that has been cut, punctured, or perforated is left at the treatment site, then the procedure can be completed, but the tissue may interfere with additional treatments

Engineering Contradiction:
Improveprocedure efficiencyVSAvoidtissue interference
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The manipulator arm is designed to grasp and extract treated tissue from the treatment site after energy delivery. The arm can penetrate the treated area, grasp the coagulated or treated tissue, and remove it from the site, preventing it from interfering with subsequent treatments or procedures.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The manipulator arm serves as an intermediary tool between the energy delivery electrode and the treated tissue. It facilitates the removal of treated tissue without requiring direct contact with the electrode or complex manipulation mechanisms, simplifying the process while effectively preventing tissue interference.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

Facilitates efficient and safe treatment of tissue layers by allowing for simultaneous energy delivery and fluid injection, reducing procedure duration and complexity, and minimizing tissue interference, thus enhancing procedural safety and efficacy.

Implementation Method 1

applying electrical energy to or into tissue with a distal element of a first medical device

Methodology Applied
Scientific EffectElectrical energy application: Joule Heating

Implementation Method 2

an end cap that lifts or urges treated tissue away from the treatment site

Methodology Applied
Scientific EffectMechanical force application: Mechanical Force

Implementation Method 3

delivering or injecting fluid into, under, and/or around tissue with the distal element of the first medical device

Methodology Applied
Scientific EffectFluid injection: Pressure Gradient

Data Source

PatentUS20250380860A1Medical systems, devices, and related methods for applying energy, delivering fluid, and/or manipulating tissue
Publication Date: 2025.12.18 BOSTON SCI MEDICAL DEVICE LTD
  • US20250380860A1 patent drawing
  • US20250380860A1 patent drawing
  • US20250380860A1 patent drawing

AI summary

A medical system includes an insertion device, a medical device, and an end cap. The insertion device includes an insertion shaft with a working channel. The medical device includes a device shaft and a tool. The end cap includes a proximal extension and a cap tip extending distally of the proximal extension. The proximal extension forms an end cap lumen. The device shaft and the tool of the medical device are movably positioned within the working channel of the insertion shaft. The end cap is positioned within a distal portion of the working channel such that the tool and a distal portion of the device shaft are movable through the end cap lumen.