Biodegradable Mesh Anchorage with API Elution for Tissue Ingrowth Reduction
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Solution Overview
Problem
Existing anchoring devices for implantable medical devices face challenges such as difficulty in removal due to tissue ingrowth, undesirable mass, and insufficient strength, leading to complications like infection and scarring.
Innovation Solution
A mesh substrate coated with a polymer and active pharmaceutical ingredients (APIs) that elutes over time, providing support, reducing tissue ingrowth, and preventing infections, while having a low areal density and adjustable mechanical properties for easy explantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If non-biodegradable anchoring devices are used to provide strong support, then the device has sufficient strength and durability, but the device becomes difficult to remove due to tissue ingrowth and has undesirable mass
Solution Approach 1:
The patent applies parameter changes by using biodegradable polymers with controlled degradation rates. The anchoring device transitions from a permanent state to a degradable state, allowing it to provide strength during the healing period and then gradually lose mass for easy removal. The degradation time and rate can be adjusted by selecting different polymer compositions and molecular weights.
Solution Approach 2:
The patent uses composite materials by combining biodegradable polymer matrices with embedded active pharmaceutical ingredients. This creates a multi-functional material that simultaneously provides mechanical support, controlled drug delivery, and eventual biodegradation. The composite structure allows the device to maintain strength while incorporating therapeutic agents that prevent infection and reduce inflammation.
2Weight of stationary object
If biodegradable anchoring devices are used to reduce mass and facilitate removal, then the device can be easily explanted, but the device has insufficient strength and does not provide desired support
Solution Approach 1:
The patent adjusts the degradation rate parameters of the biodegradable polymer to match the healing timeline. By controlling the polymer composition and molecular weight, the device maintains sufficient strength during the critical healing period and then degrades at an optimal rate for easy removal. This parameter optimization resolves the contradiction between low mass and sufficient strength.
3Duration of action of stationary object
If anchoring devices are left in place to provide continuous support, then the device maintains structural integrity, but tissue fibrotic in-growth occurs making removal difficult
Solution Approach 1:
The patent employs a disposable, biodegradable anchoring device that is designed to fulfill its support function temporarily and then degrade naturally. This eliminates the need for long-term presence in the body, preventing chronic tissue ingrowth and associated complications. The device is engineered for a specific service life aligned with the healing process.
Solution Approach 2:
The patent controls the degradation time parameter to match the healing duration. The device provides support during the critical healing period and then degrades at a controlled rate, preventing long-term tissue ingrowth while maintaining necessary structural integrity throughout the treatment period.
4Weight of stationary object
If anchoring devices have high mass to provide support, then the device has sufficient structural strength, but the device causes undesirable fibrotic in-growth and is difficult to remove
Solution Approach 1:
The patent optimizes the mass parameter by using biodegradable polymers with controlled degradation. The device starts with sufficient mass to provide support but is engineered to reduce its mass over time through biodegradation. This dynamic mass reduction prevents chronic fibrotic in-growth while maintaining necessary support during the healing period.
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 solution effectively reduces tissue ingrowth, minimizes post-surgical complications, and facilitates easy removal of the anchoring device by eluting APIs to prevent infections and adjust mechanical properties, ensuring the device's support and safety during the healing process.
Implementation Method 1
the polymer coating can include a drug to be released into the body of the patient as the polymer coating degrades during implantation
Data Source
AI summary
An anchorage device comprising a mesh substrate coupled to an implantable medical device is disclosed, where the mesh substrate has a coating comprising a polymer, and the mesh further comprises at least one active pharmaceutical ingredient. The active pharmaceutical agent is designed to elute from the mesh over time. The mesh substrate can be configured to reduce the mass of the anchorage device such that tissue in-growth and/or scar tissue formation at the treatment site is reduced. In some embodiments, the mesh substrate can be formed with a mesh having a low areal density. In some embodiments, the mesh substrate can include one or more apertures or pores to reduce the mass of the substrate.