Leadless Pacing Device Fixation Tine Design
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Solution Overview
Problem
Current medical devices for cardiac pacing, such as conventional pacemakers, often require leads that can be cumbersome and may not provide reliable fixation within the heart, leading to a need for alternative solutions for leadless cardiac pacing devices and delivery systems that can effectively anchor and orient within cardiac tissue.
Innovation Solution
The development of a leadless cardiac pacing device with a fixation mechanism comprising a tine that transitions between an elongated delivery configuration and a curved deployed configuration, utilizing a nitinol wire within an electrically insulating material, and an ultrasound marker for precise placement, along with a delivery catheter featuring a distal holding section with retention features to maintain the tine in the delivery configuration during advancement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional pacemakers with leads are used, then cardiac pacing function is provided, but the device becomes cumbersome and fixation reliability is reduced
Solution Approach 1:
The patent removes the lead component from the pacemaker system, extracting the problematic connection element that caused cumulative failure. The leadless pacemaker encapsulates all functional elements (electrodes, battery, circuitry) within a single implantable unit, eliminating the lead that connected external pulse generators to cardiac tissue, thereby resolving the reliability issue associated with lead-related complications.
Solution Approach 2:
The patent combines previously separate components (pulse generator, electrodes, battery, and fixation mechanisms) into a single integrated leadless pacemaker unit. This merging eliminates the need for leads and reduces the number of implantable components, directly addressing the technical contradiction by simplifying the overall system while maintaining cardiac pacing functionality.
2Reliability
If a fixation mechanism is added to the leadless pacing device, then anchoring security is improved, but device complexity increases
Solution Approach 1:
The fixation mechanism is designed to perform multiple functions: it provides anchoring security to prevent device dislodgement, serves as a deployment mechanism from the delivery catheter, and enables orientation control within the heart. By making the fixation structure multi-functional, the patent avoids adding separate components for each function, thereby improving anchoring security without proportionally increasing device complexity.
Solution Approach 2:
The fixation mechanism transitions from a compressed state during delivery to an expanded or engaged state after implantation. This dynamic transformation allows the device to maintain a compact form during delivery (reducing complexity) while providing robust anchoring once deployed (improving reliability). The fixation elements can expand, unfold, or engage with cardiac tissue automatically upon release from the delivery catheter.
3Object-affected harmful factors
If the tine is made flexible to curve away from the electrode, then tissue trauma is reduced, but fixation strength may be compromised
Solution Approach 1:
The fixation mechanism utilizes curved or spheroidal geometries in the tine structure, allowing it to conform to the contours of cardiac tissue rather than imposing rigid linear contacts. This curvature reduces stress concentration and distributes mechanical loads more evenly across the tissue-device interface, minimizing tissue trauma while maintaining adequate fixation strength through geometric adaptation to the implantation site.
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
Enables secure anchoring and precise placement of the pacing device within the heart, reducing tissue trauma and improving the reliability of cardiac pacing without the need for external leads, while allowing for easy retrieval and repositioning.
Implementation Method 1
a fixation mechanism secured relative to the housing. The fixation mechanism may comprise a tine configured to move between an elongated delivery configuration and a curved deployed configuration
Implementation Method 2
an ultrasound marker for precise placement
Data Source
Figure 1
Figure 2
Figure 3A
AI summary
An implantable leadless pacing device and delivery system may comprise an implantable leadless pacing device and a catheter configured to deliver the implantable leadless packing device to a target location. The implantable device may comprise a power source, circuitry operatively coupled to the power source, a housing at least partially enclosing the circuitry, a first electrode secured relative to and offset from a longitudinal axis of the housing and exposed exterior to the housing, and a fixation mechanism secured relative to the housing. The fixation mechanism may comprise at least one tine configured to move between an elongated delivery configuration and a curved deployed configuration and radially offset from the first electrode. The catheter may comprise a distal holding section defining a cavity configured to receive the implantable leadless pacing device.