Additive Lead Construction with Alignable Markers for Implant Alignment
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Solution Overview
Problem
Existing manufacturing processes for medical devices like catheters and leads face challenges in navigating tortuous body paths due to conflicting design considerations, such as flexibility and stiffness, and lack precision in aligning features during deployment, leading to difficulties in positioning implantable devices accurately.
Innovation Solution
Additive manufacturing techniques allow for the customization of medical devices by incorporating internal components and alignable marker elements, enabling precise placement and navigation through 3D printing multiple layers and features, such as internal grooves and alignable marker elements, which enhance the device's ability to align with target sites.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional extrusion manufacturing is used, then manufacturing simplicity is maintained, but manufacturing precision and alignment of features are limited
Solution Approach 1:
The lead is divided into multiple segments including a lead body, a connector, and multiple alignable marker elements. Each segment can be manufactured separately using additive manufacturing and then assembled, allowing for precise alignment features on each component while maintaining overall manufacturing simplicity through modular construction.
Solution Approach 2:
Alignable marker elements are pre-positioned and integrated into the lead structure during the additive manufacturing process. These markers are preliminarily configured with precise spatial relationships to anatomical landmarks, eliminating the need for complex post-manufacturing alignment procedures.
2Ease of operation
If the lead is made sufficiently flexible to navigate tortuous paths, then navigability is improved, but structural stability and positioning precision deteriorate
Solution Approach 1:
The lead incorporates alignable marker elements at specific locations along its length, creating local reference points that provide precise positioning information without requiring the entire lead structure to be rigid. The markers maintain precise geometric relationships locally while the lead body remains flexible for navigation.
Solution Approach 2:
The patent replaces complex mechanical alignment systems with image-guided alignment using alignable marker elements visible during imaging procedures. This substitution allows the lead to remain mechanically simple and flexible while achieving precise positioning through visual feedback from the markers.
3Manufacturing precision
If alignable marker elements are added to the lead, then alignment precision is improved, but device complexity increases
Solution Approach 1:
The alignable marker elements are merged with the lead structure through additive manufacturing, integrating the markers directly into the lead body or connector rather than attaching them as separate components. This merging reduces overall device complexity while maintaining the alignment precision benefits of the markers.
Solution Approach 2:
The alignable marker elements serve multiple functions: they provide alignment references during implantation, serve as imaging markers for verification, and can be integrated with the structural components of the lead. This multi-functionality reduces the need for separate alignment devices, thereby reducing overall device complexity.
Data Source
AI summary
Implantable apparatus includes two or more alignable marker elements, and systems and methods for manufacturing such implantable apparatus, and methods to utilize such implantable apparatus. For example, the implantable apparatus may include a first alignable marker element and a second alignable marker element that may be used to ensure proper alignment with a target site.