Leadless Pacemaker Delivery Catheter with Site Testing Electrodes
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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 optimal solutions for delivering self-contained, leadless cardiac pacemakers to specific locations within the heart, necessitating improved delivery systems that facilitate precise navigation and deployment.
Innovation Solution
A delivery device with a handle assembly and a shaft featuring a distal region, a device containment housing, and a deployment mechanism, equipped with electrodes for testing deployment sites, pressure sensors, and tracking sensors, allowing for precise placement and deployment of leadless cardiac pacemakers within the heart.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional pacemakers with leads are used, then cardiac pacing function is provided, but the leads become cumbersome and complicate the delivery process
Solution Approach 1:
The patent extracts and removes the leads from the conventional pacemaker system, creating a leadless cardiac pacemaker that is self-contained and delivered as a single unit. This eliminates the complexity of lead management during delivery and implantation while maintaining the essential cardiac pacing function.
Solution Approach 2:
The leadless cardiac pacemaker is nested within a delivery catheter system that guides it to the target location. The pacemaker device is contained within the catheter during delivery, then deployed from the catheter at the implantation site, simplifying the overall delivery process compared to managing separate leads.
2Measurement precision
If leadless cardiac pacemakers are delivered to specific locations, then precise placement is achieved, but advanced navigation capabilities are required
Solution Approach 1:
The delivery system incorporates sensors that provide real-time feedback about the position and orientation of the leadless pacemaker during delivery. This feedback enables the operator to make precise adjustments to achieve accurate placement at the target location within the heart chamber.
Solution Approach 2:
The delivery catheter system is designed with multiple functions including navigation, positioning, testing, and deployment capabilities in a single integrated device. This multi-functionality reduces the need for separate specialized tools while achieving precise placement.
3Manufacturing precision
If deployment mechanism is added to the delivery device, then precise deployment is enabled, but device complexity increases
Solution Approach 1:
The deployment mechanism is pre-positioned and prepared within the delivery catheter before reaching the target site. The system is configured in advance so that deployment can be executed precisely when needed, rather than requiring complex real-time adjustments during the deployment moment.
Solution Approach 2:
The delivery catheter acts as an intermediary that simplifies the deployment process. It provides a controlled environment for releasing the pacemaker and ensures accurate placement through its structural guidance, reducing the complexity of the deployment mechanism itself.
4Reliability
If electrodes are distributed on the containment housing for site testing, then potential deployment locations can be evaluated, but device complexity increases
Solution Approach 1:
The electrodes distributed on the containment housing serve multiple functions: they can be used for testing potential deployment sites, for providing pacing stimuli, and for sensing cardiac activity. This multi-functionality justifies the added complexity by eliminating the need for separate testing devices.
Solution Approach 2:
The electrodes are pre-positioned on the containment housing before delivery, allowing site testing to be performed in advance of final deployment. This preliminary testing ensures reliable site selection and reduces the need for additional components or procedures.
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 and precise delivery and deployment of leadless cardiac pacemakers, minimizing tissue trauma and ensuring accurate placement, while allowing for testing of potential sites before final fixation, thereby enhancing the effectiveness of cardiac pacing.
Implementation Method 1
a pressure sensor configured to obtain an indication of pressure in the chamber of the patient's heart
Implementation Method 2
a first electrode and a second electrode disposed on an exterior surface of the device containment housing to form a stimulation bipole
Data Source
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AI summary
A delivery and deployment device may include a handle assembly and a shaft extending distally from the handle assembly. A device containment housing may be coupled to a distal region of the shaft and may extend distally therefrom. The distal containment housing may be configured to accommodate at least a portion of the IMD therein. The IMD may, for example, be a leadless pacemaker, a lead, a neurostimulation device, a sensor or any other suitable IMD. A plurality of electrodes may be distributed about an exterior surface of the device containment housing such that at least some of the plurality of electrodes may be positioned to test a potential IMD deployment location before deploying the IMD.