Inflatable Surgical Device with External Fixation for Stable Access

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Solution Overview

Problem

Current minimal invasive cardiothoracic surgical devices lack a reliable means to fix the device in the body, leading to challenges in maintaining access to surgical sites and increasing procedural risks and discomfort for patients.

Innovation Solution

A surgical device with at least one elongated flexible member that can be fixed outside the body, combined with inflatable chambers forming a contiguous wall, allowing for stable positioning and expansion to exert force on tissues, and optionally paired with a stylet for navigation and positioning.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional open-thoracic surgery is used to provide access to surgical sites, then high quality repair is achieved, but considerable procedural related health risks and major discomfort are encountered by patients

Engineering Contradiction:
Improvequality of surgical repairVSAvoidprocedural health risks and patient discomfort
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent employs an inflatable chamber with flexible walls that can be inserted in a collapsed state and expanded in situ to create a stable working space. This flexible shell approach allows minimal invasive access while maintaining the structural integrity needed for high-quality surgical repair, thereby reducing patient trauma and discomfort compared to traditional open surgery.

Inventive Principle:
Principle #30Flexible shells and thin films

2Object-affected harmful factors

If minimal invasive surgery with small incisions is used, then operative stress is reduced and fewer scars are left, but the space between ribs limits instrument passage and access to surgical sites

Engineering Contradiction:
Improveoperative stress and scarringVSAvoidinstrument passage and access to surgical site
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The inflatable device is divided into multiple chambers that can be independently or collectively inflated to create and maintain a working space. This segmented structure allows the device to adapt to the limited intercostal space while providing sufficient room for instrument passage and surgical manipulation, resolving the contradiction between minimal invasion and operational ease.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device transitions from a collapsed one-dimensional state during insertion to a three-dimensional expanded state at the surgical site. This dimensional transformation allows the device to pass through small incisions and then create a volumetric working space that facilitates instrument passage and surgical access without requiring large initial openings.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

3Ease of operation

If high pressure gas insufflation is used to expose the heart, then minimal invasive access is achieved, but the lungs are crushed

Engineering Contradiction:
Improveminimal invasive access to heartVSAvoidlung crushing
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The inflatable chamber acts as an intermediary physical barrier between the surgical field and the surrounding lung tissue. By providing a structured, contained expansion space, the device allows for heart exposure without requiring direct high-pressure gas insufflation that would crush the lungs, thus mediating between access requirements and lung protection.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Ease of operation

If known inflatable devices are used for minimal invasive surgery, then access to surgical sites is provided, but the devices lack means of fixing in the body leading to challenges in maintaining access

Engineering Contradiction:
Improveaccess to surgical siteVSAvoidmaintainment of access and device positioning
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The device incorporates fixation elements that are prepared and positioned in advance during the insertion phase. These elements engage with anatomical structures or external fixation devices before inflation occurs, ensuring that once the chamber is expanded to create the working space, the device remains securely positioned without migration, thereby maintaining reliable access throughout the procedure.

Inventive Principle:
Principle #10Preliminary action

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 device enables reliable creation and maintenance of space at surgical sites, reducing procedural risks and discomfort by providing stable access for minimally invasive cardiothoracic surgery without lung separation or high-pressure insufflation, facilitating successful surgical methods.

Implementation Method 1

at least one inflatable chamber which can be inflated (for example using gas or a liquid such as buffered saline solution) from a collapsed state to an expanded state

Methodology Applied
Scientific EffectInflation:

Data Source

PatentUS10070855B2Surgical device for providing access to a surgical site
Publication Date: 2018.09.11 UMC UTRECHT HLDG BV
  • US10070855B2 patent drawing
  • US10070855B2 patent drawing
  • US10070855B2 patent drawing

AI summary

A surgical device (5) for application in a treatment performed on the human or animal body (1) with the aim of providing access to a surgical site in the body, includes at least one inflatable chamber (70, 71, 72) which can be inflated from a collapsed state to an expanded state, in which expanded state the device is suitable for exerting a force on an organ or tissue at the surgical site, at least one elongated flexible member (8, 80), which member at its proximal end (801) is operatively connected to the device, and which member has a length to allow the distal end (800) of the member to be fixed to a fixation site (100, 101) outside of the body, and methods of using this device.