Rigid Fastener for Leadless Pacemaker Catheter Coupling

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Solution Overview

Problem

Current medical implant technologies, particularly leadless pacemakers, face challenges in being delivered, implanted, repositioned, and explanted using the same catheter tooling due to the need for high flexibility and the risk of trauma, thrombogenesis, and entanglement with patient anatomy, especially when using femoral routing.

Innovation Solution

A medical implant with a rigid fastener configured for primary engagement and tether modes, allowing for recapture, featuring a divot structure and various hitch geometries to ensure torque translation and minimize misalignment, paired with a steerable catheter system for efficient implantation and explantation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a flexible catheter is used for femoral routing, then the catheter can navigate complex vasculature, but the risk of trauma, thrombogenesis, and entanglement increases

Engineering Contradiction:

Improvecatheter flexibilityVSAvoidtrauma and entanglement risk

Core Design Contradiction:

Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The catheter system employs dynamic elements including a steerable distal section that can be actively controlled to navigate vasculature, and a recapture wire that can transition between deployed and retracted states. The catheter shaft incorporates flexible segments that allow controlled articulation, enabling the system to adapt to vascular anatomy while maintaining control to minimize trauma and entanglement risks

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The implant fastener serves as an intermediary element that provides a secure attachment point between the catheter and the implant. The fastener includes engagement features such as lobes or hooks that interact with corresponding elements on the catheter, creating a reliable mechanical connection that reduces the risk of dislodgement and entanglement while allowing controlled manipulation during the procedure

Inventive Principle:

Principle #24Intermediary (Mediator)

2Productivity

If a single catheter is used for both implantation and explantation, then procedural efficiency improves, but the catheter must accommodate multiple functions

Engineering Contradiction:

Improveprocedural efficiencyVSAvoidcatheter multi-functionality

Core Design Contradiction:

ProductivityVSDevice complexity

Solution Approach 1:

The catheter system is designed with universal features that enable both implantation and explantation functions. The coupling element at the catheter tip can engage with the implant fastener for implantation, and the same catheter can recapture the implant for explantation. The steerable distal section and recapture wire provide versatile control capabilities that serve multiple procedural needs, allowing a single catheter to perform multiple functions without requiring separate devices

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The catheter is divided into functional segments including a steerable distal section for navigation and engagement, a mid-section with recapture wire deployment capability, and a proximal control section. This segmentation allows each portion to be optimized for specific tasks while working together as an integrated system, enabling multi-functionality without excessive overall complexity

Inventive Principle:

Principle #1Segmentation

3Manufacturing precision

If a rigid fastener is used for torque translation, then implant anchoring precision improves, but the fastener may cause tissue trauma

Engineering Contradiction:

Improveimplant anchoring precisionVSAvoidtissue trauma

Core Design Contradiction:

Manufacturing precisionVSObject-affected harmful factors

Solution Approach 1:

The fastener design incorporates local quality variations with rigid structural elements for torque transmission and anchoring precision in critical areas, while featuring smooth surfaces and rounded geometries at tissue-contacting portions. The fastener may include localized engagement features such as lobes or hooks that provide mechanical advantage for anchoring while minimizing stress concentration and tissue damage. The catheter coupling elements are designed with complementary geometries that distribute forces evenly, reducing localized trauma while maintaining anchoring precision

Inventive Principle:

Principle #3Local quality

Data Source

PatentEP3056157B1A medical implant with a proximal rigid fastener for interaction with a coupling element of a catheter

Publication Date: 2018.03.14 BIOTRONIK SE & CO KG

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AI summary

The application relates to a medical implant (10) with a proximal rigid fastener for interaction with a coupling element (300) of a catheter (100). The application further relates to a system comprising the medical implant and the catheter, where the catheter can be used to position the medical implant and to reposition or explant the medical implant.