Leadless Pacemaker Retrieval Catheter With Locking Docking Cap
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Conventional cardiac pacing systems face issues such as subcutaneous bulges, erosion, infection, complex connections, difficult surgical procedures, and challenges in delivering and retrieving leadless pacemakers, which can lead to embolism and increased procedure time and cost.
Innovation Solution
A catheter system with a retriever, such as a grasper or snare, is used to engage and deliver or retrieve leadless pacemakers, facilitating single-catheter deployment and reducing the risk of spontaneous release, with features like flexible arms and sheaths for secure attachment and torque transmission.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional delivery catheter systems are used to deliver leadless pacemakers, then the pacemaker can be delivered to the implant site, but the catheter length (approximately 42 mm or longer) makes navigation difficult and increases the footprint at the implant site
Solution Approach 1:
The delivery system is divided into multiple separable components: a compression device, a delivery catheter, and a leadless pacemaker. The compression device can be detached after deployment, effectively reducing the functional length of the system remaining in the patient's body and simplifying navigation.
Solution Approach 2:
The compression device is extracted from the delivery system after the leadless pacemaker is deployed. This extraction reduces the footprint and length of the system at the implant site, making navigation easier and reducing the burden on the patient.
2Reliability
If tether-based delivery systems are used, then the leadless pacemaker can be attached to the delivery catheter, but once tether alignment is lost, the pacemaker may spontaneously release causing embolism and requiring retrieval
Solution Approach 1:
The system transitions from a static tether-based attachment to a dynamic compression-based attachment. The compression device actively compresses the pacemaker against the catheter wall, maintaining attachment through force rather than alignment, which remains reliable even when the catheter moves or flexes.
Solution Approach 2:
The compression device acts as an intermediary between the delivery catheter and the leadless pacemaker. Instead of directly attaching the pacemaker to the catheter via tether, the compression device mediates the attachment through mechanical compression, providing more reliable and controllable attachment.
3Reliability
If conventional pacemakers with separate pulse generators and leads are used, then pacing function can be provided, but multiple connection points increase opportunities for malfunction including erosion, infection, and disconnection
Solution Approach 1:
The pulse generator and leads are merged into a single integrated leadless pacemaker unit. This eliminates the separate connection points between pulse generator and leads, removing the interfaces that are prone to erosion, infection, disconnection, and other malfunctions.
Solution Approach 2:
The leadless pacemaker performs multiple functions within a single device: it generates pacing signals, delivers them directly to the heart muscle, and senses cardiac activity. This multi-functionality eliminates the need for separate leads and pulse generators, reducing the number of potential failure points.
4Ease of manufacture
If subcutaneous pulse generator placement is used, then the generator can be implanted, but it creates a skin bulge that patients find unsightly and can lead to erosion, extrusion, and infection
Solution Approach 1:
The pulse generator is extracted from the subcutaneous space and placed directly inside the heart chamber. This eliminates the skin bulge and removes the generator from the pathway of potential erosion and infection, while the delivery catheter provides a clean surgical approach.
Solution Approach 2:
The pulse generator is moved from a subcutaneous (under the skin) position to an intracardial (inside the heart) position. This dimensional change relocates the device to a space that does not create external visible bulges and is protected from skin-related complications.
5Productivity
If leadless pacemakers are delivered via conventional catheter systems, then delivery is possible, but retrieval requires a different catheter system increasing procedure time and complexity
Solution Approach 1:
The delivery catheter is designed with universal functionality to perform both delivery and retrieval operations. The same catheter system that delivers the leadless pacemaker can also retrieve it if needed, eliminating the need for separate retrieval catheters and simplifying the procedural workflow.
Data Source
AI summary
Implementations described and claimed herein provide systems and methods for delivering and retrieving a leadless pacemaker. In one implementation, a leadless pacemaker has a docking end, and the docking end having a docking projection extending from a surface. A docking cap has a body defining a chamber. The docking cap has a proximal opening into the chamber. The proximal opening is coaxial with a longitudinal axis of a lumen of a catheter. A retriever has a flexible grasper with a first arm disposed opposite a second arm. Each of the first arm and the second arm form a hinge biased radially outwards from the longitudinal axis. The docking cap locks the first arm and the second arm on the docking projection when the body is sheathed over the retriever until the flexible grasper is disposed within the chamber.