Tether Assembly Threaded Attachment for Leadless Pacemaker Delivery
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Solution Overview
Problem
Current implantable cardiac pacing devices face mechanical complications and MRI compatibility issues due to elongate lead wires, prompting the need for compact devices implanted close to the pacing site, with challenges in efficient delivery and fixation.
Innovation Solution
A tether assembly for delivery tools featuring an elongate shaft with an external thread and end wall for secure attachment and detachment of medical devices, along with a handle assembly for torque transmission, facilitating efficient deployment and retrieval of compact implantable medical devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If elongate lead wires are used in traditional pacemakers, then the device can be implanted remotely from the heart, but mechanical complications and MRI compatibility issues occur
Solution Approach 1:
The patent extracts and removes the elongate lead wires from the pacemaker system, transitioning to a leadless design where the pulse generator is implanted directly in the heart without external wire connections, thereby eliminating the source of mechanical complications and MRI incompatibility
Solution Approach 2:
The invention changes the spatial dimension of device placement by moving from a remote subcutaneous implantation with long lead wires to a direct intracardial implantation of a compact leadless device, fundamentally altering the dimensional relationship between the pulse generator and the heart
2Reliability
If compact leadless devices are implanted close to the pacing site, then mechanical complications and MRI compatibility improve, but delivery and fixation become more challenging
Solution Approach 1:
The delivery system is segmented into distinct functional components including an introducer for vascular access, a deployment tool for precise positioning, and a fixation mechanism for secure attachment, allowing each component to be optimized for its specific function in the implantation process
Solution Approach 2:
The patent introduces a tether as an intermediary element that connects the implanted device to the delivery tool, enabling operators to manipulate, position, and secure the device through the tether connection while maintaining control during the implantation procedure
3Ease of operation
If tethers are used to secure and retrieve devices, then device positioning can be adjusted, but assembly and construction of the delivery tool become more complex
Solution Approach 1:
The tether assembly is designed with multi-functionality, serving as both a securing mechanism during implantation and a retrieval tool after deployment, while the external thread and end wall configuration allows the same structure to provide both attachment and controlled detachment functions
Solution Approach 2:
The invention inverts the traditional approach by designing the tether attachment mechanism with an external thread on the tether rather than an internal thread in the device, allowing the tether to actively engage the device bore and providing a hard stop through the end wall that prevents over-rotation while enabling controlled detachment
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
Enhances the efficiency of implantable medical device delivery tools by providing secure attachment and easy detachment mechanisms, reducing mechanical complications and improving MRI compatibility, while maintaining device stability and ease of operation.
Implementation Method 1
the attachment member includes an external thread and an end wall, the end wall extending orthogonally with respect to a direction of travel within a valley of the external thread to provide a hard stop for a threaded attachment bore of a medical device
Implementation Method 2
a knob coupled to a proximal end of the shaft, wherein the aforementioned shaft translates torque, applied to the knob, from the knob to the attachment member in order to detach the tether assembly from the bore of the medical device
Data Source
Figure 1
Figure 2A~2C
Figure 3A~3B
AI summary
A tether assembly for a delivery tool that deploys an implantable medical device includes an elongate shaft and an attachment member coupled to a distal end of the shaft, wherein the attachment member includes an external thread and an end wall, the end wall extending orthogonally with respect to a direction of travel within a valley of the external thread to provide a hard stop for a threaded attachment bore of the medical device, when the bore is mated with the external thread. The tether assembly may extend within a lumen defined by an elongate tube of an inner assembly of the delivery tool, such that the attachment member thereof is located in proximity to a distal member of the inner assembly, the distal member being coupled to a distal end of the tube and forming a distal opening of the lumen.