Protective Sleeve Structure for Steerable Biostimulator Delivery
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Solution Overview
Problem
Existing biostimulator transport systems with tubular sheaths are stiff and difficult to navigate, causing steering difficulties and interfering with communication through conductive fluids, and often require oversteering or isolation of the leadless cardiac pacemaker.
Innovation Solution
A biostimulator transport system with a protective sleeve that transitions between protective and unprotective states, allowing the fixation element to be exposed for implantation while maintaining system steering and communication, featuring slits, caps, or collapsible designs to facilitate this transition.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a tubular sheath is used to cover the leadless cardiac pacemaker during delivery, then the pacemaker is protected during transport, but the sheath causes steering difficulties and reduces deflection angle
Solution Approach 1:
The protective sleeve is designed to dynamically change its state from a protective configuration during transport to an unprotective configuration during implantation. The sleeve includes a collapsible structure with folds that allow it to collapse when compressed by the delivery catheter, enabling the pacemaker to be exposed and implanted while maintaining protection during delivery.
Solution Approach 2:
The protective sleeve is divided into multiple folds or segments that can collapse independently. This segmentation allows the sleeve to maintain its protective function during transport while enabling easy collapse during implantation to expose the pacemaker for fixation without causing steering difficulties.
2Reliability
If a tubular sheath is used to cover the leadless cardiac pacemaker, then the pacemaker is protected during delivery, but communication through conductive fluid is interfered with
Solution Approach 1:
The protective sleeve dynamically transitions from a protective state during delivery to an unprotective state during implantation. When the sleeve collapses, it no longer interferes with conductive fluid communication, allowing the pacemaker to communicate effectively with external devices while maintaining protection during the delivery phase.
3Reliability
If the protective sleeve is made stiff to provide adequate protection, then the pacemaker is well-protected during transport, but the system becomes difficult to navigate
Solution Approach 1:
The protective sleeve is designed with a dynamic structure that can change its stiffness and configuration based on the operational phase. During delivery, the sleeve maintains a protective configuration, but when compressed by the delivery catheter, it collapses to a minimal profile, enabling easy navigation and steering without the stiffness issues of a rigid protective sheath.
Data Source
AI summary
A biostimulator transport system includes a catheter shaft extending to a distal shaft end. The biostimulator transport system includes a biostimulator coupling mounted on the distal shaft end to receive a biostimulator having a fixation element. The biostimulator transport system includes a protective sleeve movable relative to the biostimulator coupling between a protective state and an unprotective state. The protective sleeve covers the fixation element in the protective state. The protective sleeve does not cover the fixation element in the unprotective state. The protective sleeve has a distal section including one or more folds that open when the protective sleeve moves from the protective state to the unprotective state.