Cardiac Lead Delivery Guide with Imaging Markers
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Solution Overview
Problem
Current medical procedures for implanting cardiac pacemakers face challenges in accurately positioning leads within the thoracic cavity to avoid vital structures and ensure effective therapeutic electrical pulses, due to limitations in anatomical alignment and depth determination.
Innovation Solution
A medical procedure guide with alignment markings and imaging markers is used to facilitate precise placement of cardiac therapy leads, incorporating flexible design and adhesive properties for secure positioning, and sensors for real-time tissue characterization to determine optimal insertion depth and avoid critical structures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional manual lead insertion methods are used, then the procedure is simpler and requires fewer auxiliary devices, but the accuracy of lead placement and determination of insertion depth is insufficient
Solution Approach 1:
A procedure guide is introduced as an intermediary device between the lead and the target anatomical structure. The guide includes alignment markings that correspond to anatomical landmarks and imaging markers that provide real-time visual feedback during insertion, enabling precise lead placement without requiring complex surgical navigation systems.
Solution Approach 2:
The procedure guide incorporates imaging markers with distinct radiopaque properties that create visible contrasts on imaging devices. These markers allow real-time visualization of the guide's position and depth during insertion, enabling the operator to accurately determine when the lead has reached the target depth without complex electronic feedback systems.
2Reliability
If deeper insertion is pursued to reach the heart, then therapeutic efficacy is improved, but the risk of damaging vital structures increases
Solution Approach 1:
The procedure guide incorporates imaging markers that provide real-time feedback to the operator during insertion. The markers are positioned at known depths and create visible signals on imaging devices, allowing continuous monitoring of insertion depth and automatic termination when the target depth is reached, preventing penetration into vital structures while ensuring adequate therapeutic positioning.
Solution Approach 2:
The procedure guide is pre-marked with alignment indicators that correspond to anatomical landmarks and target depths before insertion. This preliminary configuration of reference markers eliminates the need for intraoperative anatomical estimation and provides built-in depth guidance that prevents excessive insertion while ensuring adequate reach to the heart.
3Measurement precision
If rigid positioning is used to ensure accuracy, then lead placement precision is improved, but adaptability to different patient anatomies is reduced
Solution Approach 1:
The procedure guide is designed with flexible materials that allow it to conform to different patient anatomies while maintaining the relative positions of its imaging markers and alignment markings. This dynamic adaptability enables the guide to accommodate variations in rib spacing, sternum thickness, and other anatomical features across different patients, ensuring consistent accuracy without requiring patient-specific customization.
Data Source
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AI summary
Systems, methods and devices to facilitate insertion of a lead for cardiac therapy into an intercostal space associated with the cardiac notch of a patient are described including devices, methods and medical procedure templates to facilitate insertion proximate to a lateral margin of the patient's sternum.