Nested Tubular Delivery Device for Leadless Pacemaker
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Solution Overview
Problem
Current medical devices for delivering leadless cardiac pacemakers face challenges in navigating tortuous anatomy and ensuring effective delivery and deployment without causing tissue trauma, and there is a need for improved methods and devices to facilitate the advancement and placement of these devices within the heart.
Innovation Solution
A delivery device comprising an outer tubular member, an intermediate tubular member, and an inner tubular member, with a distal holding section and a deployment funnel that allows for fluid flow and includes features such as apertures, grooves, and porous materials to enable smooth navigation and deployment of the pacemaker, reducing tissue trauma and facilitating fluid flushing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a delivery device is designed to navigate tortuous anatomy, then the ability to reach implant sites is improved, but the device complexity increases
Solution Approach 1:
The delivery device employs a nested tubular structure with an outer tubular member, an intermediate tubular member disposed within the outer member, and an inner tubular member disposed within the intermediate member. This nesting arrangement allows the device to navigate tortuous anatomy while maintaining a relatively simple overall structure, as each tubular member can independently flex and conform to vascular pathways.
Solution Approach 2:
The delivery device is divided into multiple segmented components including the outer tubular member, intermediate tubular member, inner tubular member, distal holding section, and deployment funnel. Each segment serves a specific function and can move independently, allowing the device to adapt to complex anatomical pathways while keeping individual components simple and manageable.
2Ease of operation
If a delivery device includes multiple tubular members and moving parts, then the deployment control is improved, but the ease of operation deteriorates
Solution Approach 1:
The delivery device incorporates dynamic elements including the intermediate tubular member that can slide within the outer tubular member, and the inner tubular member that can slide within the intermediate member. The deployment funnel is also moveable between advanced and retracted positions. These dynamic components allow for precise control of the implantable device deployment while maintaining ease of operation through smooth sliding motions rather than complex mechanical systems.
3Ease of operation
If the deployment funnel is advanced into the distal holding section, then the device engagement is improved, but the fluid flow capability deteriorates
Solution Approach 1:
The deployment funnel is designed as a moveable component that can be advanced into the distal holding section to engage the implantable device, and then retracted to restore fluid flow pathways. This dynamic positioning allows the system to switch between device engagement mode and fluid flow mode, ensuring both functions are performed effectively without permanent compromise to either capability.
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 solution enhances the ability to navigate and deploy leadless cardiac pacemakers through tortuous anatomy, reduces tissue trauma, and ensures effective fluid flow for safe and efficient delivery, improving the placement of the devices within the heart.
Implementation Method 1
at least a portion of the deployment funnel may include a porous material that enables fluid flow through pores thereof
Data Source
AI summary
Delivery devices, systems, and methods for delivering implantable leadless pacing devices are disclosed. An example delivery device may include an intermediate tubular member and an inner tubular member slidably disposed within a lumen of the intermediate tubular member. A distal holding section may extend distally of a distal end of the intermediate tubular member and define a cavity therein for receiving an implantable leadless pacing device. The device may be configured to enable fluid flushing of the delivery device prior to use, to remove any air from within the device as well as providing the option of fluid flow during use of the delivery device.