Flexible Container for Minimally Invasive Protuberant Region Formation

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Solution Overview

Problem

Current medical procedures for forming protuberant regions, such as breast augmentation, are invasive due to the need for larger perforations and delivery routes as implant size increases, limiting the reduction in size of implants and thus the invasiveness for patients.

Innovation Solution

A method involving a flexible container introduced into the body in a contractive state, filled with a filling material to expand and form a protuberant region, using a catheter system to minimize the initial size of the perforation and delivery route, with the container retaining the filling material to maintain the region's stability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Volume of moving object

If a larger implant is used to form a protuberant region, then the protrusion effect is improved, but the size of the perforation and delivery route must be increased, worsening the invasiveness of the procedure

Engineering Contradiction:
Improveimplant volumeVSAvoidinvasiveness
Core Design Contradiction:
Volume of moving objectVSObject-affected harmful factors

Solution Approach 1:

The implant is divided into two separate delivery components: a collapsible container that can be compressed to a small size for delivery, and a filling material delivered separately. This segmentation allows the implant volume to be large when needed for protrusion while enabling small delivery dimensions through compression of the container and filling material separately.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The collapsible container is designed to be nested within the delivery catheter system in a compressed state. The container can be collapsed to fit within the catheter lumen, allowing the large-volume implant to be delivered through a small-access pathway. After deployment, the container expands to its full volume to provide the desired protuberant effect.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Object-affected harmful factors

If the implant size is reduced for easier delivery, then the invasiveness is reduced, but the protrusion effect and stability of the formed region deteriorate

Engineering Contradiction:
ImproveinvasivenessVSAvoidstability of protuberant region
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The container is designed with dynamic properties that allow it to transition from a compressed delivery state to an expanded functional state. The container material and structure are engineered to maintain structural integrity and stability once expanded, ensuring the protuberant region remains stable while enabling minimally invasive delivery through dynamic size change.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The physical parameters of the container (volume, shape, rigidity) are changed from a compressed state during delivery to an expanded state after implantation. This parameter transformation allows the implant to be delivered through a small catheter while maintaining the ability to form a stable, large-volume protuberant region once deployed and filled.

Inventive Principle:
Principle #35Parameter changes

3Productivity

If a pre-filled implant is used, then the protuberant region can be formed immediately, but the delivery route size must be large enough to accommodate the filled implant, increasing invasiveness

Engineering Contradiction:
Improveprocedure efficiencyVSAvoiddelivery route size
Core Design Contradiction:
ProductivityVSLength of stationary object

Solution Approach 1:

The implant system is segmented into a collapsible container and separate filling material delivery. The container is delivered in a collapsed, empty state through a small catheter, then the filling material is delivered separately through the same or a different catheter lumen. This segmentation enables efficient procedure execution while maintaining small delivery route dimensions.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The collapsible container serves as an intermediary structure that receives the filling material after both the container and filling material have been delivered through the catheter system. This intermediary approach allows efficient procedure execution while maintaining small delivery route dimensions, as the container is filled in situ after deployment.

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

This approach reduces the invasiveness of the procedure by minimizing the initial container size and ensuring the stability and longevity of the formed protuberant region, allowing for a less-invasive and more controlled augmentation.

Implementation Method 1

a second catheter having a distal portion to which a container having flexibility is detachably attached... the second catheter includes a second lumen through which to deliver a filling material to inside the container

Methodology Applied
Scientific EffectFluid delivery and pressure: Pressure Increase

Data Source

PatentUS10603160B2Medical device and method for forming a protuberant region
Publication Date: 2020.03.31 TERUMO KK
  • US10603160B2 patent drawing
  • US10603160B2 patent drawing
  • US10603160B2 patent drawing

AI summary

Procedural methods are provided that are capable of forming a protuberant region, in which the surface of a living body protrudes, in a less-invasive manner and a medical device capable of forming the protuberant region in a less-invasive manner. A procedural method for forming a protuberant region, in which a surface of a living body protrudes, includes an introduction step of introducing a container having flexibility into the living body, a protuberant region forming step of forming the protuberant region, in which the surface of the living body protrudes, by filling the container with a filling material to expand the container, and a placement step of placing the expanded container in the living body.