Decellularized Tissue Fistula Filler Shape Retention
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Solution Overview
Problem
Current treatments for fistulas, such as fistulotomy and the use of fibrin glue or porcine small intestine submucosa plugs, often result in recurrence, reinfection, and incontinence, highlighting the need for a more effective method to maintain the shape and structure of decellularized tissue for therapeutic applications.
Innovation Solution
The method involves decellularizing tissue or a portion of an organ, placing it in a shaping mold, and irradiating it to maintain the desired shape. This process creates a decellularized extracellular matrix with defined shapes, which can be used as surgical fillers or plugs for fistula repair, among other applications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If decellularized tissue is placed in a shaping mold and irradiated, then the shape retention and structural definition are improved, but the manufacturing complexity increases
Solution Approach 1:
The decellularized tissue is placed in a shaping mold before irradiation to pre-establish the desired shape. This preliminary positioning ensures that when irradiation occurs, the tissue maintains the predefined shape, achieving manufacturing precision through advance preparation rather than complex real-time control systems.
Solution Approach 2:
A shaping mold serves as an intermediary device between the decellularized tissue and the irradiation process. The mold provides the physical constraint that defines the shape, allowing the tissue to retain the desired form during and after irradiation without requiring complex active control mechanisms.
2Stability of the object's composition
If decellularized tissue is irradiated to maintain shape, then the structural stability is improved, but the processing time increases
Solution Approach 1:
The irradiation process changes the physical-chemical parameters of the decellularized tissue, creating cross-links that stabilize the structure. This parameter change allows the tissue to maintain its shape and structural integrity over time, achieving long-term stability through a one-time processing step rather than continuous active maintenance.
3Productivity
If conventional surgical methods are used for fistula treatment, then the procedure is simple and quick, but recurrence and reinfection occur frequently
Solution Approach 1:
The decellularized tissue is processed to have specific local qualities - it is shaped to fit the fistula tract precisely and has localized structural properties that promote healing. This local customization of the tissue quality improves treatment effectiveness by addressing the specific anatomical and functional requirements of the fistula site, rather than using generic surgical approaches.
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 irradiation process effectively maintains the shape and structure of decellularized tissue, allowing for the creation of defined shapes that can be used therapeutically, such as in fistula repair, without the side effects associated with current treatments.
Implementation Method 1
The method can include at least partially reducing malleability of an isolated at least partially hydrated at least partially decellularized organ or portion thereof in a mold. In some cases, a method can comprise exposing an at least partially hydrated at least partially decellularized organ or portion thereof to a select dose of radiation.
Data Source
AI summary
Disclosed herein are methods for retention of shape of decellularized tissue or of a portion of an organ can be accomplished through the irradiation of the decellularized tissue or the portion of the organ inside a shaping mold. The enclosure of decellularized tissue or a portion of an organ inside of a mold or other constraining material, such as stainless steel or platinum or polymers such as polytetrafluoroethylene (PTFE) or polycaprolactone (PCL), allows the tissue to take on the shape of the mold or constraint and subsequently retain that shape after it is irradiated. This can result in decellularized extracellular matrix having defined (pre-determined) shapes. The system can include a hollow device which contains the filler or plug. The system may be inserted into the fistula tract and the filler or plug may be deployed by pulling, pushing or otherwise expelling the filler or plug into the tract.