Variable Stiffness Guide Element for Medical Implant Delivery
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Solution Overview
Problem
Current guide elements, such as guidewires and sutures, face challenges in delivering and anchoring medical instruments and implants, particularly in longer, tortuous paths, due to insufficient stiffness and excessive flexibility, which can lead to displacement and require excessive tensioning.
Innovation Solution
The development of guide elements with variable stiffness, comprising a flexible distal portion and a stiff proximal portion, where the flexible portion can be used as a tensioning element and left in the body while the stiff portion is withdrawn, allowing for secure anchoring and manipulation of implants through a tether-anchor assembly with detachable components and various attachment mechanisms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If guide elements are configured with sufficient column strength to resist axial elongation or buckling, then insertion and withdrawal is facilitated, but flexibility is reduced making it difficult to navigate tortuous paths
Solution Approach 1:
The guide element is divided into multiple segments with different stiffness characteristics - a stiff proximal portion for structural support and a flexible distal portion for navigation. This segmentation allows each portion to perform its specialized function independently, resolving the contradiction between overall strength and localized flexibility.
Solution Approach 2:
Different portions of the guide element are given different mechanical properties - the proximal portion has high column strength while the distal portion has high flexibility. This local differentiation of quality allows the guide element to simultaneously provide structural support where needed and adaptability where needed, eliminating the need to choose between strength and flexibility.
2Ease of operation
If a flexible portion is left in the body as part of the implant, then tissue manipulation and anchoring is enabled, but device complexity increases due to detachable components
Solution Approach 1:
The guide element is pre-configured with a detachable attachment mechanism that allows the flexible portion to be separated from the stiff portion at a predetermined location. This preliminary preparation of the detachment capability simplifies the implantation process, as the separation can be achieved through simple mechanical action rather than complex procedures.
Solution Approach 2:
A detachable attachment mechanism serves as an intermediary between the stiff proximal portion and the flexible distal portion. This intermediary component enables controlled separation of the two portions while maintaining their individual functions, allowing tissue manipulation by the flexible portion without requiring the entire guide element to remain in place.
Data Source
AI summary
Described herein are devices and methods for guide elements configured with variable stiffness, with one or more flexible portions and one or more stiff portions. The flexible portion is be used as a tensioning element of a cinchable implant to tighten or compress tissues while the stiff portion is used to facilitate the insertion or withdrawal of portions of the implant or instruments acting on the implant. The guide element is further configured to be separated or severed between the flexible and stiff portions so that a flexible portion is left within the body as part of the implant, while the stiff portion is withdrawn from the body after implantation is completed.