Hydrogel Implantable Device for Post-Resection Tissue Formation

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Solution Overview

Problem

Conventional markers fail to facilitate new breast tissue formation within a resection cavity post-surgery, leading to deformities and complicating site identification post-resection.

Innovation Solution

A hydrogel-based implantable device with encapsulated tissue-specific cells is inserted into the resection cavity, providing a bioreactor for cell integration and structural support, along with bioabsorbable frames and radiopaque markers for site identification.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of information

If conventional markers are used for site identification, then site visibility is achieved, but tissue formation is not facilitated leading to deformities

Engineering Contradiction:
Improvesite identificationVSAvoidtissue deformity
Core Design Contradiction:
Loss of informationVSShape

Solution Approach 1:

The patent combines two separate functions into a single implantable device: (1) site identification through radiopaque markers and (2) tissue formation facilitation through hydrogel scaffold with encapsulated cells. This merging resolves the contradiction by achieving both site visibility and preventing deformities simultaneously, rather than using conventional markers that only provide identification.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The implantable device serves multiple functions: it provides radiopaque markers for imaging/identification, offers structural support through the frame, facilitates tissue formation through the hydrogel scaffold with encapsulated cells, and maintains cavity shape. This multi-functionality allows the device to address both site identification and tissue formation needs in a single solution.

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

2Productivity

If a hydrogel scaffold with encapsulated cells is used, then tissue formation is accelerated, but device complexity increases

Engineering Contradiction:
Improvetissue formation rateVSAvoidimplantable device structure
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The encapsulated cells are prepared and encapsulated in the hydrogel scaffold before implantation. This preliminary action allows the cells to be pre-positioned and pre-conditioned, enabling them to immediately begin facilitating tissue formation upon implantation, thus accelerating the tissue formation rate while maintaining a manageable device structure.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The hydrogel scaffold acts as an intermediary structure that provides a three-dimensional matrix for cell encapsulation, protection, and controlled release. This intermediary structure simplifies the overall device design by consolidating multiple functions (cell delivery, structural support, tissue formation facilitation) into a single integrated component rather than requiring separate complex mechanisms.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Strength

If the frame is fully encapsulated in hydrogel scaffold, then structural support is provided, but manufacturing difficulty increases

Engineering Contradiction:
Improvestructural supportVSAvoiddevice assembly
Core Design Contradiction:
StrengthVSEase of manufacture

Solution Approach 1:

The implantable device is segmented into distinct components: a frame structure and a hydrogel scaffold. This segmentation allows each component to be manufactured separately using appropriate techniques (frame through molding or fabrication, hydrogel through gelation processes), and then assembled together. This approach maintains structural support while simplifying manufacturing compared to creating a fully integrated single-piece structure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The hydrogel scaffold forms a flexible, gel-like structure that can conform to and encapsulate the frame. This flexible encapsulation provides structural support and tissue formation facilitation without requiring rigid, complex assembly processes. The hydrogel's gelation process naturally conforms to the frame shape, simplifying the encapsulation step compared to rigid shell formation.

Inventive Principle:
Principle #30Flexible shells and thin films

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

Accelerates tissue formation and reduces deformities by promoting cell interaction, while ensuring site visibility for subsequent procedures.

Implementation Method 1

preparing a hydrogel scaffold with encapsulated cells... gelation of the hydrogel precursor solution initiated to form the hydrogel scaffold

Methodology Applied
Scientific EffectGelation: Gel

Implementation Method 2

the one or more markers may be comprised of a non-bioabsorbable, radiopaque material

Methodology Applied
Scientific EffectRadiopacity: Absorption (EM radiation)

Data Source

PatentEP4090284B1Hydrogel-based implantable device
Publication Date: 2025.07.16 HOLOGIC INC
  • EP4090284B1 patent drawingFigure 1
  • EP4090284B1 patent drawingFigure 2
  • EP4090284B1 patent drawingFigure 3

AI summary

Methods and devices for facilitating post-resection tissue formation to accelerate healing are provided. A hydrogel scaffold with encapsulated cells may be prepared. The encapsulated cells may be cells of the patient undergoing the resection that correspond to a type of the tissue resected. The hydrogel scaffold may be integrated with a frame to form an implantable device for insertion into a cavity created by the resection. The hydrogel scaffold and the frame may be bioabsorbable, and the frame may include non-bioabsorbable, radiopaque markers spaced along the frame. Upon insertion of the implantable device into the cavity, the encapsulated cells may interact with native cells to facilitate new tissue formation within the hydrogel scaffold and other areas of the cavity, the frame may provide temporary structural support for the cavity to reduce deformations as new tissue is being formed, and the markers may enable identification of the resection site.