Medical Device Lead Integrated Pressure-Resisting Member
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Medical device leads face issues with slippage within suture sleeves, leading to dislodgment and potential damage from excessive suture force, increased manufacturing and surgical costs due to separate suture sleeves, and abrasion-related failures due to stiffness, which complicates navigation through patient anatomy.
Innovation Solution
Integration of pressure-resisting members, such as suture-anchoring and lead-strengthening members, directly formed with the lead's insulating jacket or central core, featuring grooves, rims, and fibers to resist compressive and abrasive forces, eliminating the need for separate suture sleeves and enhancing durability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If separate suture sleeves are used to protect leads, then the lead is protected from crushing force, but the lead may slip within the suture sleeve causing dislodgment
Solution Approach 1:
The suture-anchoring member is integrated directly into the lead structure, merging the lead body and anchoring function into a single unified component. This eliminates the separate suture sleeve and its associated slippage problems while maintaining protection from crushing forces through the integrated design.
Solution Approach 2:
The suture-anchoring member features a flexible structure with grooves and rims that can deform to grip the lead securely. The flexible design allows the member to conform to the lead surface and maintain secure anchoring without slippage, while still providing protection from external crushing forces.
2Reliability
If excessive force is applied to suture ties to prevent slippage, then anchoring stability is improved, but the lead body and underlying components may be damaged
Solution Approach 1:
The suture-anchoring member acts as an intermediary between the suture tie and the lead body. It distributes the anchoring forces across its integrated structure and features like grooves and rims, preventing concentration of excessive force on the lead body and protecting underlying components from damage.
3Object-affected harmful factors
If additional layers of material are added to protect against abrasion, then protection is improved, but the lead becomes stiffer and more difficult to navigate
Solution Approach 1:
The pressure-resisting member is integrated at specific locations where abrasion and crushing forces are most likely to occur, rather than adding uniform layers along the entire lead length. This localized protection maintains lead flexibility in other areas, enabling easier navigation through patient anatomy.
Solution Approach 2:
The pressure-resisting member integrates multiple materials with complementary properties - some layers provide abrasion and crush resistance while other layers maintain flexibility. This composite structure achieves both protection and navigability by combining materials with different mechanical characteristics.
4Ease of manufacture
If separate suture sleeves are used, then manufacturing and surgical procedures are standardized, but manufacturing cost and surgical time increase
Solution Approach 1:
The suture-anchoring member is merged with the lead body into a single integrated component, reducing the total number of separate parts. This simplification decreases manufacturing complexity and surgical assembly time while maintaining standardized manufacturing processes for the integrated structure.
Data Source
AI summary
A medical device configured to be secured to an individual may include a housing containing one or more electrical components, and one or more leads electrically connected to the housing. Each lead may include an insulating jacket that surrounds a central core including one or more conductors, and at least one pressure-resisting member integrally formed with one or both of the insulating jacket or the central core. The pressure-resisting member is configured to resist one or more forces exerted into the central core. For example, the pressure-resisting member may include one or more of a suture-anchoring member or a lead-strengthening member.