Protective Sleeve for Biostimulator Delivery and Steering
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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 fail to translate leadless cardiac pacemakers effectively.
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, corrugated walls, or other mechanisms to facilitate this transition.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a tubular sheath is used to cover the leadless cardiac pacemaker, then the fixation element is protected during delivery, but the system becomes stiff and difficult to navigate to the septal wall
Solution Approach 1:
The protective covering is divided into multiple segments or sections that can move independently relative to each other. This segmentation allows the sheath to maintain structural integrity for protection while enabling bending and steering movements through differential motion of the segments, resolving the contradiction between protection and navigability.
Solution Approach 2:
The protective sheath transitions from a static, rigid structure to a dynamic structure with variable stiffness. Through mechanisms such as shape memory materials, phase transitions, or mechanical articulation, the sheath can adjust its rigidity along its length, providing protection where needed while remaining flexible for steering in other regions.
2Reliability
If a tubular sheath is used to cover the leadless cardiac pacemaker, then the fixation element is protected, but steering or actuation difficulties occur such as reduction in deflection angle requiring oversteering
Solution Approach 1:
Different regions of the protective sheath are assigned different mechanical properties. The distal portion or specific segments are made more flexible or articulated to allow greater deflection angles, while proximal portions maintain sufficient rigidity for protection. This local differentiation eliminates the need for oversteering corrections.
Solution Approach 2:
The protective sheath is designed with nested or telescoping sections that can slide relative to each other. This nesting allows the sheath to compress or expand radially, enabling sharp deflections and steering maneuvers without compromising the protective coverage of the fixation element.
3Reliability
If a tubular sheath is used to cover the leadless cardiac pacemaker, then the fixation element is protected, but the leadless cardiac pacemaker cannot be translated effectively
Solution Approach 1:
The protective sheath incorporates dynamic friction control mechanisms, such as controllable expansion sections or variable viscosity fluids, that allow easy longitudinal translation when needed while maintaining protection during stationary periods. The sheath can transition between a low-friction state for translation and a high-friction state for stable protection.
Solution Approach 2:
The protective covering uses flexible thin-walled construction that minimizes radial stiffness while maintaining axial strength. This allows the sheath to slide smoothly over the pacemaker during translation without creating binding forces, while still providing adequate protection when deployed.
4Reliability
If a tubular sheath is used to cover the leadless cardiac pacemaker, then the fixation element is protected, but communication through conductive fluid is interfered with
Solution Approach 1:
The protective sheath incorporates porous or permeable sections that allow conductive fluid to pass through while maintaining structural protection. These porous regions enable electrical signals and communication waves to transmit through the sheath to the pacemaker, resolving the contradiction between physical protection and electrical communication.
Solution Approach 2:
The sheath introduces conductive gel or fluid-filled channels as intermediary media between the external environment and the pacemaker. These intermediaries transmit electrical signals and communication waves through the protective barrier, allowing communication while maintaining the protective function of the sheath.
Data Source
Figure 1~2
Figure 3
Figure 4~5
AI summary
A biostimulator transport system (302) includes a catheter shaft (304) extending to a distal shaft end (306). The biostimulator transport system (302) includes a biostimulator coupling (308) mounted on the distal shaft end (306) to receive a biostimulator (100) having a fixation element (106). The biostimulator transport system (302) includes a protective sleeve (314) movable relative to the biostimulator coupling (308) between a protective state and an unprotective state. The protective sleeve (314) covers the fixation element (106) in the protective state. The protective sleeve (314) does not cover the fixation element (106) in the unprotective state. The protective sleeve (314) has a distal section (3104) including one or more folds that open when the protective sleeve (314) moves from the protective state to the unprotective state.