Tissue Puncture Devices With Variable Stiffness and Distal Anchoring
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Solution Overview
Problem
Existing medical devices face challenges in efficiently accessing and puncturing tissue sites, particularly on the left side of the heart, due to limitations in curvature and stiffness of current sheaths and guidewires, leading to inefficient procedures and multiple device exchanges.
Innovation Solution
Development of a flexible dilator with varying stiffness regions, allowing it to conform to the curvature of steerable sheaths while maintaining sufficient rigidity for tissue advancement, combined with guidewires that provide reliable support and anchoring for puncturing tissue sites.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a sheath is made stiffer to provide better support for tissue advancement, then support capability is improved, but the ability to conform to curvature and access tissue sites is worsened
Solution Approach 1:
The sheath is divided into multiple sections with different stiffness characteristics. The proximal section is stiffer to provide support for tissue advancement, while the distal section is more flexible to conform to curvature and access tissue sites. This segmentation allows each section to optimize its mechanical properties for its specific function.
Solution Approach 2:
Different portions of the sheath are assigned different mechanical properties. The proximal section has higher rigidity to maintain structural support, while the distal section has lower rigidity to enable curvature conformance. This local differentiation of material or structural properties resolves the contradiction between overall support capability and local adaptability.
2Ease of operation
If a guidewire is made more flexible to improve maneuverability to tissue sites, then ease of operation is improved, but the ability to provide reliable support and anchoring is worsened
Solution Approach 1:
The guidewire is segmented into a flexible distal section for maneuverability and a stiffer proximal section for providing reliable support and anchoring. The flexible distal section can be maneuvered to access tissue sites, while the stiffer proximal section maintains structural integrity and provides anchoring capability.
Solution Approach 2:
The guidewire exhibits dynamic mechanical properties where the distal section is more flexible for maneuvering during insertion, while the proximal section provides stable support and anchoring during the procedure. This dynamic differentiation of stiffness allows the guidewire to fulfill multiple functions.
3Reliability
If multiple devices are used sequentially to access tissue sites, then each device can be optimized for its specific function, but device complexity and procedure time are worsened
Solution Approach 1:
Multiple functions previously requiring separate devices are combined into a single integrated device. The sheath and guidewire are designed to work together as a unified system, eliminating the need for multiple device exchanges and reducing procedural complexity while maintaining functional optimization.
Solution Approach 2:
The integrated device system performs multiple functions that previously required separate devices. The sheath provides both support and curvature conformance, while the guidewire provides both maneuverability and anchoring, creating a universal device that replaces multiple specialized devices.
4Productivity
If a single access point is used to reach left side tissue sites, then procedural efficiency is improved, but the ability to reach these sites from superior access points is worsened due to curvature limitations
Solution Approach 1:
The sheath and guidewire system is designed with dynamic flexibility to accommodate the curvature required for superior access to left side tissue sites. The flexible distal section allows the device to conform to the anatomical curvature, enabling access from superior approach points while maintaining procedural efficiency.
Solution Approach 2:
The mechanical parameters of the device, particularly flexibility and curvature conformance, are optimized to enable superior access. By adjusting the flexibility parameter of the distal section, the device can adapt to the anatomical curvature required for accessing left side tissue sites from superior approach points.
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 efficient and repeatable puncture of tissue sites with reduced device exchanges, enabling procedures like transseptal puncture and lead delivery through a single access point, improving procedural efficiency and reducing procedure time.
Implementation Method 1
the distal section defines a distal section curved portion configured to automatically form a distal coil in a deployed state for anchoring the distal section upon the distal section being advanced through the puncture
Implementation Method 2
The medical device includes an active tip at a distal end of the distal section and is operable to deliver energy to create a puncture through the tissue
Implementation Method 3
A further embodiment of the present invention has the elongate member comprising a reverse taper. The reverse taper increases in outer diameter from the distal end of the distal section curved portion to the distal section straight portion
Data Source
AI summary
Novel and unique medical devices and associated methods are disclosed, for a medical device for puncturing tissue at a tissue site. The medical device includes an elongate member having a distal section defining a distal section curved portion and a distal section straight portion. The distal section straight portion is distal to the distal section curved portion. An active tip is located at a distal end of the distal section. The active tip is operable to deliver energy to create a puncture through the tissue. The medical device includes a constant diameter layer. The distal section straight portion includes a minimum diameter portion located proximal to a constant diameter portion, and the constant diameter layer surrounds the minimum diameter portion.