Retention Mechanism for Implantable Lead Anchoring
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Solution Overview
Problem
The subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation procedure is prolonged due to suturing steps and results in multiple incisions, increasing the risk of infection and leaving visible scars, necessitating a simplification of the implant method to reduce procedure time and incisions while ensuring effective lead anchoring.
Innovation Solution
A retention device with an elongate body and securing mechanisms that can shift from a delivery configuration to a deployed configuration to anchor the lead to tissue, potentially reducing the number of incisions required and eliminating the need for suturing by using a sheath to compress the securing mechanisms during implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If suturing steps are used to secure the lead in position, then lead stability is improved, but procedure time increases and multiple incisions are required
Solution Approach 1:
The patent extracts the suturing function from the lead anchoring process by introducing a separate retention device that provides anchoring through its securing mechanisms rather than through traditional sutures, thereby eliminating the need for time-consuming suturing steps while maintaining lead stability
Solution Approach 2:
The retention device acts as an intermediary between the lead and the tissue, providing a mechanical anchoring solution through expanding securing mechanisms that eliminate the need for direct suturing of the lead to tissue, thus reducing procedure time while maintaining stability
2Adaptability or versatility
If multiple incisions are made for lead implantation, then lead positioning flexibility is improved, but infection risk increases and visible scars remain
Solution Approach 1:
The patent segments the anchoring function from the incision requirement by designing a retention device with multiple securing mechanisms that can be deployed at a single incision site, thereby maintaining positioning flexibility while reducing the number of incisions and associated infection risks
Solution Approach 2:
The retention device utilizes the radial dimension by expanding securing mechanisms outward from the lead body to engage tissue, providing anchoring flexibility without requiring multiple linear incisions along the lead path, thus reducing infection risk while maintaining positioning adaptability
3Stability of the object's composition
If traditional suture fixation is used, then lead anchoring is achieved, but device complexity increases due to multiple components and steps
Solution Approach 1:
The patent merges the retention and anchoring functions into a single integrated retention device that surrounds the lead and provides securing mechanisms, eliminating the need for separate suture materials, needles, and tying steps, thus reducing overall device complexity while maintaining anchoring stability
Solution Approach 2:
The retention device provides self-service anchoring through its expanding securing mechanisms that automatically engage the tissue when deployed from the compressed state, eliminating the need for manual suturing operations and reducing the complexity of the implantation procedure
Data Source
AI summary
Retention devices for use with an implantable medical device (IMD) are disclosed. An illustrative retention device may comprise an elongate body including a hollow lumen configured to receive a lead of the IMD and an outer surface configured to receive a suture. The retention device may also include a securing mechanism configured to push against tissue of a patient.