Delivery Catheter With Expandable Atraumatic End for Leadless Pacemakers
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Solution Overview
Problem
Conventional cardiac pacemakers face issues such as bulging under the skin, erosion, extrusion, infection, and complex connections that can lead to malfunction, while leadless pacemakers require improved delivery systems.
Innovation Solution
A delivery catheter system with a tubular body and atraumatic end featuring a braided or woven construction, allowing for the secure and atraumatic implantation and retrieval of leadless biostimulators using a displacement mechanism to expand or contract around the pacemaker.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional pacemakers are implanted with leads and pulse generators, then cardiac pacing function is provided, but the pulse generator creates a skin bulge that is unsightly and can be manipulated by patients
Solution Approach 1:
The patent combines the pulse generator and electrodes into a single integrated leadless pacemaker unit, eliminating the need for separate leads and subcutaneous pulse generator. This merging resolves the technical contradiction by providing the pacing function while removing the skin bulge and manipulation issues associated with separate components.
Solution Approach 2:
The leadless pacemaker serves multiple functions within a single device: it generates pacing pulses, delivers them directly to the heart muscle through integrated electrodes, and senses cardiac activity. This multi-functionality eliminates the need for separate lead wires and external pulse generators, resolving the contradiction between simplicity and functional completeness.
2Reliability
If conventional pacemakers use connected leads and pulse generators, then cardiac pacing is achieved, but multiple connection points create opportunities for malfunction
Solution Approach 1:
The patent extracts and eliminates the complex connector and lead interface system from conventional pacemakers. By integrating the electrodes directly into the pulse generator housing, the invention removes multiple potential failure points including connector malfunctions, lead wire breaks, and insulation damage, thereby improving reliability.
3Length of moving object
If leadless pacemakers are delivered through catheters, then implantation is simplified, but the catheter must be small enough to navigate vessels yet large enough to accommodate the pacemaker
Solution Approach 1:
The catheter incorporates an expandable distal portion that can dynamically change its internal diameter. During delivery, the catheter maintains a small profile to navigate blood vessels easily. Upon deployment, the distal portion expands to provide a larger chamber for receiving and deploying the leadless pacemaker, thus resolving the contradiction between small delivery size and adequate deployment space.
4Ease of operation
If the catheter distal portion is expanded to receive the pacemaker, then delivery is facilitated, but the catheter must be able to return to a compressed state for retrieval
Solution Approach 1:
The catheter's distal portion can change its physical parameters (diameter and volume) on demand. It expands to a larger configuration during pacemaker delivery to facilitate easy insertion and deployment. The catheter can then return to a compressed, low-profile state for safe retrieval and storage, resolving the contradiction between delivery ease and storability.
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
Facilitates the secure implantation and retrieval of leadless pacemakers without causing tissue damage, reducing the risk of complications and simplifying the surgical procedure.
Implementation Method 1
the atraumatic end is formed from an elastic memory material
Data Source
AI summary
Disclosed herein is a delivery catheter for implanting a leadless biostimulator. The delivery catheter includes a shaft and a tubular body having a lumen and an atraumatic end. The atraumatic end includes at least one of a braided, woven or mesh construction configured to facilitate the atraumatic end changing diameter. When a distal portion of the shaft is coupled to a proximal region of the leadless biostimulator, at least one of distally displacing the tubular body relative to the shaft or proximally displacing the shaft relative to the tubular body causes the leadless biostimulator to be received in the volume of the atraumatic end and the atraumatic end to encompass the leadless biostimulator. Conversely, at least one of proximally displacing the tubular body relative to the shaft or distally displacing the shaft relative to the tubular body causes the leadless biostimulator to exit the volume of the atraumatic end.