Bioremodelable Stoma Graft with Sizing Pattern for Hernia Prevention
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Solution Overview
Problem
Current synthetic mesh devices for parastomal hernia repair are associated with complications such as tissue irritation, erosion, and high recurrence rates, and lack effective prophylactic solutions to prevent hernia formation around surgically created stomas.
Innovation Solution
A biocompatible tissue reinforcement device featuring a graft member made from naturally-derived or synthetic bioremodelable materials, with a stomal aperture that can be resized to fit the patient's anatomy, using a sizing pattern for precise adjustment and flaps to reinforce the stoma site, which can be implanted prophylactically or to repair existing hernias, and is designed to be resorbable to promote tissue ingrowth.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If synthetic mesh devices are used for parastomal hernia repair, then mechanical reinforcement strength is improved, but tissue irritation and erosion occur
Solution Approach 1:
The patent changes the material parameter from synthetic non-resorbable mesh to bioremodelable extracellular matrix that can be resorbed by the body. This parameter change maintains initial mechanical strength for reinforcement while eliminating long-term tissue irritation and erosion caused by permanent synthetic materials.
Solution Approach 2:
The bioremodelable ECM material is designed to be gradually resorbed and replaced by the patient's own tissue over time. The synthetic or animal-derived matrix serves as a temporary scaffold that provides mechanical support during healing, then is discarded as native tissue takes over the reinforcement function.
2Reliability
If synthetic mesh devices are used for hernia repair, then reinforcement effectiveness is improved, but prophylactic application is problematic due to field contamination risks
Solution Approach 1:
The patent changes the material origin parameter from synthetic to biologically-derived (animal or human ECM). This biological origin allows the material to be more compatible with tissue and less prone to contamination issues, enabling safe prophylactic use before stoma creation without the same field contamination concerns as synthetic materials.
Solution Approach 2:
The bioremodelable ECM acts as a temporary, disposable scaffold that serves its reinforcement purpose during the critical healing period, then is naturally resorbed. This short-lived biological material avoids the long-term contamination and complication issues associated with permanent synthetic mesh.
3Object-affected harmful factors
If resorbable bioremodelable materials are used, then tissue compatibility is improved, but long-term mechanical support may be reduced
Solution Approach 1:
The bioremodelable ECM is designed to be temporarily present during the critical healing phase, providing mechanical support when needed, then is naturally resorbed as the patient's own tissue matures and takes over the load-bearing function. The temporary scaffold is discarded once native tissue recovery is sufficient.
Solution Approach 2:
The bioremodelable material performs preliminary reinforcement action during the vulnerable early healing period, creating a stable environment for tissue regeneration. Once the native tissue has recovered sufficient strength, the temporary ECM scaffold completes its mission and is resorbed, having fulfilled its preliminary support role.
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 provides long-term reinforcement of the stoma site with reduced risk of hernia recurrence, minimizing tissue irritation and complications associated with synthetic mesh devices, while promoting natural tissue growth and integration.
Implementation Method 1
the material of the graft member is resorbable by the body during or after the generation of a new bed of reinforcing tissue around the stomal site
Data Source
AI summary
An implantable tissue reinforcement device useful for treating or preventing the formation of parastomal hernias forming about a surgically created stoma. The tissue reinforcement device can comprise a synthetic or mammalian-derived sheet-like graft member, such as a resorbable material that promotes tissue ingrowth, wherein a sizing pattern is included that comprises linear indicia radiating outward from a stomal aperture. The linear indicia facilitate creation of a resized stomal opening in the graft member sufficiently large to allow passage of the resected bowel portion. A series of cuts made along the indicia create a plurality of flaps about the resized opening that are configured to abut the bowel portion and enhance reinforcement the stomal region after implantation. In one embodiment, the linear indicia comprises a series of weakened (e.g., perforated) lines that facilitate the cutting of the material by a scalpel, scissors, etc. The clinician resizes the stomal opening to a known diameter using reference indicia, such as diameter indicia and circular guide indicia. The sizing pattern can be imprinted on or etched into the material of the graft member, or it can be at least partially located on a separate template that is either laid over the graft member, preattached as a cuttable overlay, or used as a reference guide.