ECM Pouch Structure for Implantable Medical Devices
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Solution Overview
Problem
Conventional medical devices implanted in the body often face issues such as inflammation, infection, and thrombogenesis, leading to premature failure and the need for additional surgical procedures to remove them, which can cause pain and trauma to the patient.
Innovation Solution
A method for creating a pouch structure using extracellular matrix (ECM) sheets with lock-stitched seams to securely encase medical devices like pacemakers and defibrillators, providing a biocompatible and stable environment that reduces harsh biological responses and allows for easier device retention and removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional medical devices are implanted in the body, then the device can perform its medical function, but inflammation, infection, and thrombogenesis occur leading to premature failure
Solution Approach 1:
The patent introduces an extracellular matrix (ECM) pouch as an intermediary barrier between the medical device and the body tissue. The ECM pouch is formed by joining multiple ECM sheets together to create a containment structure that houses the device, preventing direct contact between device materials and host tissue, thereby eliminating the harmful biological responses while maintaining device functionality
Solution Approach 2:
The patent uses composite construction by joining multiple ECM sheets together using lock-stitched seams to create a multi-layered pouch structure. This composite ECM material provides enhanced mechanical strength and biocompatibility compared to single-layer ECM, resolving the contradiction between device reliability and biological compatibility
2Ease of repair
If medical devices are removed through secondary surgical procedure, then the device can be extracted, but patient experiences pain, discomfort, and additional trauma
Solution Approach 1:
The ECM pouch is prepared in advance during the initial implantation procedure, creating a pre-formed containment structure that facilitates future device removal. The pouch maintains device position and integrity over time, allowing for straightforward extraction through the same incision without requiring additional surgical trauma, thus making device removal easier and less painful
3Strength
If ECM sheets are joined together to form pouch structure, then mechanical strength is provided to hold device, but manufacturing complexity increases
Solution Approach 1:
The patent divides the pouch manufacturing process into discrete, manageable steps: providing individual ECM sheets, joining them through lock-stitched seams, and assembling the final pouch structure. This segmentation of the manufacturing process into standardized operations reduces overall complexity while achieving the required mechanical strength through systematic assembly of multiple components
Data Source
AI summary
The present invention provides an implantable medical product in a pouch structure, comprising an extracellular matrix (ECM) structure in sheet form. The pouch structure has an internal region and is configured to receive an electrical medical device therein. In particular, a larger pouch structure is designed to accommodate a medical device having a larger size, such as a subcutaneous implantable cardioverter-defibrillators (S-ICDs). In particular, lock-stitched seamed ECM sheets form a larger pouch structure. It is preferable that the stitches can securely hold the ECM sheets together by providing mechanical strength and durability to withstand the weight of the electronic medical device. The stitches securely hold the pouch structure together and does not fall apart during trimming or cutting of the pouch structure.