Pivotable Biostimulator Electrode for Septal Pacing
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Solution Overview
Problem
Existing leadless pacemakers are rigid and lack angular mobility, making it difficult to insert a pacing electrode normal to the septal wall for left bundle branch pacing without interfering with heart structures, and often require multiple implant attempts to achieve optimal positioning.
Innovation Solution
A biostimulator with a pivotable pacing electrode and housing, featuring a joint such as a spherical bearing or universal joint, allowing the electrode to tilt and rotate relative to the housing, and a torque element for secure screwing into the septal wall, enabling angular flexibility and optimal placement without interfering with adjacent heart structures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a rigid leadless pacemaker is implanted at the interventricular septal wall for LBB pacing, then the pacing electrode can be positioned at the target site, but the pacemaker body extends into contact with and interferes with the tricuspid valve and ventricular free wall
Solution Approach 1:
The pacemaker incorporates a joint mechanism that allows the pacemaker body to pivot dynamically relative to the electrode shaft. This dynamic capability enables the body to move away from sensitive structures like the tricuspid valve and ventricular free wall while keeping the electrode positioned at the optimal LBB pacing site on the interventricular septal wall
Solution Approach 2:
The pacemaker is divided into distinct segments: an electrode shaft for positioning and a separate body housing the electronics. The joint connects these segments, allowing independent movement of each part. This segmentation enables the electrode to remain fixed at the pacing site while the body pivots to avoid interfering with adjacent heart structures
2Device complexity
If a rigid leadless pacemaker is used for LBB pacing, then the structure is simple, but it lacks angular flexibility to insert the pacing electrode normal to the septal wall
Solution Approach 1:
The joint mechanism introduces controlled dynamics to the otherwise rigid pacemaker structure. It provides angular flexibility allowing the electrode shaft to be inserted normal to the septal wall at various angles while maintaining a relatively simple overall device design
Solution Approach 2:
The joint acts as an intermediary element between the electrode shaft and the body. It mediates the angular flexibility needed for proper electrode insertion while maintaining structural integrity and electrical connectivity, adding minimal complexity to achieve the desired adaptability
3Manufacturing precision
If multiple implant attempts are made to achieve optimal electrode positioning normal to the septal wall, then the correct positioning can be achieved, but the procedure duration increases and fluoroscopic exposure increases
Solution Approach 1:
The pivotable joint allows the operator to adjust the angle of the electrode shaft relative to the body in real-time during the implantation procedure. This dynamic adjustment capability enables achieving the optimal insertion angle normal to the septal wall on the first attempt, reducing procedure duration and fluoroscopic exposure
Solution Approach 2:
The joint mechanism enables change in the angular parameter of the electrode shaft. By allowing angular adjustment, the system can adapt to different anatomical configurations and achieve optimal positioning without requiring multiple implant attempts
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The biostimulator effectively engages the septal wall for pacing while avoiding sensitive structures, providing long-term implant stability and reducing the need for multiple deployment attempts by allowing the housing to pivot away from sensitive areas.
Implementation Method 1
the joint includes a spherical bearing. For example, a ball may be connected to the pacing electrode, and a header assembly having a socket can be connected to the housing. The ball may be located and movable within the socket.
Implementation Method 2
The torque element can have a torsional stiffness that allows torque to be transmitted from the housing to the pacing electrode. For example, the pacing electrode can include a helical electrode, and torque can be transmitted through the housing and the torque element to the helical electrode to screw the pacing electrode into the target pacing site.
Data Source
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AI summary
A biostimulator (100) and a biostimulator system (200) for septal pacing, is described. The biostimulator (100) includes a joint (306) to allow a pacing electrode (106) to pivot relative to a housing (108). The housing (108) contains electrical circuitry that is electrically connected to the pacing electrode (106). The joint (306) allows the pacing electrode (106) to affix to target tissue of an interventricular septal wall (104) of a heart (102) when the housing (108) is pivoted toward an apex (105) of the heart (102).