Atraumatic Substernal Access Tool with Flexible Shaping Member
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Solution Overview
Problem
Existing methods for accessing the substernal pathway for implantation of medical leads, such as in subcutaneous ICD systems, often result in tissue damage and prolonged healing due to the lack of suitable tools for repeatable and atraumatic access, with physicians resorting to blunt dissection methods.
Innovation Solution
A medical device featuring a flexible elongate body with a shaping member that can be manipulated from a linear to a curvilinear configuration, equipped with a tip of lower durometer hardness for atraumatic tissue traversal, allowing for controlled access and pathway creation from the xiphoid process to the sternum, facilitating the insertion of medical leads without direct attachment to the heart.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If physicians use blunt dissection with fingers or forceps to access substernal anatomy, then access can be obtained, but tissue damage occurs and healing time is prolonged
Solution Approach 1:
The patent introduces a specialized tunneling tool as an intermediary device between the physician and the substernal anatomy. This tool includes a flexible elongate body with a tip that can be advanced through subcutaneous tissue to create a tunnel to the substernal space, replacing the direct manual blunt dissection method and reducing tissue trauma
Solution Approach 2:
The patent changes the physical parameters of the access method by using a flexible elongate body with specific durometer hardness (softer than traditional forceps) that can be manipulated into curvilinear configurations. This allows the tool to navigate tissue planes more gently while maintaining the ability to create the necessary pathway
2Ease of manufacture
If traditional tools are used for substernal access, then the procedure can be performed, but the process lacks repeatability and precision
Solution Approach 1:
The patent employs a dynamic tool design where the flexible elongate body can be manipulated from a linear configuration during insertion to a curvilinear configuration during tissue traversal. This dynamic adaptability allows the tool to follow the natural contours of the tissue planes, improving both precision and repeatability of the access pathway
Solution Approach 2:
The tool is designed with segmented functionality, including a distal tip portion for tissue traversal, a mid-portion for manipulation, and a proximal portion for control. This segmentation allows each portion to be optimized for its specific function, improving overall procedural precision and repeatability
3Strength
If a rigid tool is used for tissue traversal, then structural integrity is maintained, but tissue trauma increases
Solution Approach 1:
The patent utilizes a flexible elongate body made of material with specific durometer hardness that is softer than traditional rigid tools. This flexibility allows the tool to conform to tissue planes and reduce trauma, while the controlled flexibility maintains sufficient structural integrity to perform the tunneling function
Solution Approach 2:
The tool exhibits local quality variations, with the distal tip having different hardness characteristics than the proximal portion. This allows the tip to be softer for gentle tissue interaction while the proximal portion maintains greater rigidity for controlled manipulation and structural support
Data Source
AI summary
A medical device and medical method. The medical device includes a flexible elongate body defining a proximal end and a distal end. The elongate body defines a first lumen spanning from the proximal end to a location proximal to the distal end. A shaping member insertable within the first lumen is included, the shaping member is configured to retain a manipulated shape when the flexible elongate body is manipulated from a first configuration to a second configuration. A tip is coupled to the distal end.