Trans-septal Delivery Device for Leadless Pacemaker
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Solution Overview
Problem
Current medical devices for delivering leadless cardiac pacemakers face challenges in navigating through tortuous anatomy and efficiently deploying devices across the trans-atrial septum, often requiring multiple steps and potentially causing trauma to the patient.
Innovation Solution
A trans-septal delivery device with a tubular member, a distal holding section, and a penetrating tip member that can be actuated from a closed to an open position, allowing for single-stage delivery of the pacemaker across the septum, facilitated by a handle assembly and deflection mechanisms for precise navigation and deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional delivery devices are used to deliver leadless cardiac pacemakers, then the devices can be delivered through the vasculature, but they face challenges in navigating tortuous anatomy and require multiple steps for deployment across the trans-atrial septum, increasing procedural time and potential trauma
Solution Approach 1:
The patent combines the penetration function and delivery function into a single integrated distal tip portion that can both penetrate the trans-atrial septum and deliver the leadless pacemaker in one continuous motion. This merging of functions eliminates the need for separate penetration and deployment steps, reducing procedural time while maintaining precision through the integrated design of the distal tip portion.
Solution Approach 2:
The distal tip portion is designed with dynamic characteristics, allowing it to transition from a compressed delivery configuration to an expanded deployment configuration. This dynamic design enables the distal tip to adapt to the anatomical structures during navigation and deployment, improving ease of operation through tortuous anatomy while maintaining a single-stage delivery process that reduces procedural time.
2Ease of operation
If conventional multi-step delivery methods are used, then devices can be deployed across the trans-atrial septum, but the multiple steps increase procedural complexity and potential trauma to the patient
Solution Approach 1:
The patent merges the penetration and deployment operations into a single integrated action performed by the distal tip portion. This eliminates multiple discrete steps that would otherwise require separate instruments and maneuvers, simplifying the deployment process and reducing the cumulative trauma associated with multiple interventions in the trans-atrial septum.
Solution Approach 2:
The distal tip portion is pre-configured in a compressed state during delivery, allowing it to navigate to the target site with minimal profile. Upon deployment, it automatically transitions to an expanded configuration that facilitates single-stage penetration and delivery, reducing the need for additional traumatic maneuvers and simplifying the overall procedure.
3Productivity
If a single-stage delivery method is implemented, then procedural time is reduced, but the device complexity increases to accommodate penetration and delivery functions in one instrument
Solution Approach 1:
The delivery device is segmented into distinct functional components, with the distal tip portion being a self-contained module that houses both penetration and delivery capabilities. This segmentation allows the complex functions to be isolated in a dedicated component rather than distributed throughout the entire device, making the overall system more manageable despite the advanced functionality required for single-stage delivery.
Solution Approach 2:
The leadless pacemaker is nested within the distal tip portion during delivery, with the pacemaker positioned inside the hollow cavity of the tip. This nesting arrangement allows the delivery device to maintain a compact profile during navigation while providing the necessary complexity for single-stage penetration and deployment. The nested configuration enables efficient space utilization and simplifies the release mechanism.
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 efficient, minimally invasive delivery of leadless pacing devices across the trans-atrial septum with reduced procedural time and trauma, improving navigation and deployment precision.
Implementation Method 1
The penetrating tip member may include electrically activated polymer and the electrically activated polymer may be activated to actuate the penetrating tip member from the closed penetrating position to an opened position
Implementation Method 2
the trans-septal delivery device may further comprise a balloon in communication with the penetrating tip member. The balloon may be actuated to actuate the penetrating tip member from the closed penetrating position to the opened position
Data Source
AI summary
Delivery devices, systems, and methods for delivering implantable leadless pacing devices are disclosed. An example delivery device may include a tubular member and a distal holding section extending distally of a distal end of the tubular member and defining a cavity therein for receiving an implantable leadless pacing device. The delivery device may facilitate vascular delivery of the pacing device to a left side of a patient's heart. In one example, a distal tip portion may extend distal of the distal holding section and may be actuated between a closed and an opened position. When in the closed position, the distal tip portion may have a tip that can puncture or engage an opening in a septum between a left atrium and a right atrium of a patient's heart. Actuating the distal tip portion to an opened position may be utilized to dilate the puncture or opening in the septum.