Splittable Dilator Delivery System for Pacemaker Leads
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Solution Overview
Problem
Existing delivery systems for implantable medical devices face challenges in easily removing the dilator from the introducer sheath, particularly when dealing with devices having large proximal ends, such as pacemaker leads, due to the design limitations of prior art attempts like frangible distal tips.
Innovation Solution
A delivery system featuring a splittable elongated dilator with a proximal portion and a distal portion, where the distal portion is tapered and designed to split, allowing for easier removal by a handle mechanism with gripping and activator components that facilitate the splitting of the dilator relative to the introducer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a frangible distal tip is provided on the dilator, then the dilator can be peeled away from the introducer sheath upon splitting of the distal tip, but this design performs less effectively when the implantable device has a large proximal end that impedes peeling
Solution Approach 1:
The dilator is divided into multiple segments: a frangible distal tip that can split, and a proximal portion with tabs that can be manipulated by gripping mechanisms. This segmentation allows the dilator to be peeled away in controlled portions, overcoming the limitation of single-point frangibility when dealing with large proximal ends of implantable devices.
Solution Approach 2:
The frangible distal tip is pre-designed to split upon insertion or initial manipulation, creating an opening that facilitates subsequent peeling of the proximal portion. This preliminary splitting action prepares the path for easier removal of the entire dilator, especially when the implantable device has a large proximal end.
2Strength
If the dilator is made rigid to maintain strength during insertion, then it can traverse tortuous passageways effectively, but it becomes difficult to remove from the introducer sheath
Solution Approach 1:
The dilator is segmented into a rigid proximal portion that maintains strength during insertion and a frangible distal tip that can split. This allows the main body to remain strong for traversing tortuous passageways while the distal tip provides the necessary flexibility for removal through splitting and peeling actions.
Solution Approach 2:
Different portions of the dilator have different mechanical properties: the proximal portion is made rigid for strength and structural integrity during insertion, while the distal tip is made frangible for easy splitting and removal. This local differentiation of material properties resolves the contradiction between maintaining overall strength and enabling easy removal.
3Productivity
If a handle mechanism with gripping mechanisms is added to facilitate dilator removal, then removal efficiency is improved, but device complexity increases
Solution Approach 1:
The dilator incorporates tabs that extend from the proximal portion, which are designed to be engaged by simple gripping mechanisms on the handle. The tabs act as self-contained features that facilitate gripping and peeling without requiring complex mechanical systems, thus improving removal efficiency while minimizing added complexity.
Solution Approach 2:
The tabs on the dilator serve as intermediary elements between the handle mechanism and the dilator body. These tabs provide simple engagement points that translate handle activation into effective peeling motion, improving removal efficiency without requiring direct complex mechanical coupling between the handle and dilator.
Data Source
AI summary
A delivery system for an implantable member includes an elongated dilator splittable at both the proximal and distal ends. The dilator has a tapered distal end and a pair of tabs at the proximal end. An introducer for the implantable member is received in a passageway of the dilator and extends along a length of the dilator to the tapered distal end. The introducer is arranged relative to the dilator such that upon a relative proximal movement of the dilator, the tapered distal tip of the dilator splits whereby the distal end of the introducer extends therethrough. A handle has a gripping mechanism for engagement with each tab for initiating proximal movement of the dilator relative to the introducer upon rotation of the gripping mechanism. The handle is structured for splitting the dilator proximal portion upon the relative proximal movement of the dilator.