Catheter Flexible Distal Tip for Atraumatic Tissue Safety
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Solution Overview
Problem
Existing catheters for cardiac electrophysiology procedures often cause tissue damage due to their distal tips, either through perforation or mechanical injury, especially in small diameter catheters, and incorporating a tip electrode increases complexity and cost while risking detachment within the body.
Innovation Solution
A catheter design featuring a flexible distal tip segment with a pre-formed bend, allowing it to exit the introducer laterally, reducing the risk of direct tissue contact, and eliminating the need for a tip electrode by using a shape-memory wire and adhesive for securement, while incorporating sensing and energy delivery elements along the working segment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a round or spherical tip electrode is used to prevent tissue damage, then tissue safety is improved, but device complexity and manufacturing cost increase
Solution Approach 1:
The patent removes the tip electrode entirely from the catheter design. Instead of using a spherical or rounded tip electrode to prevent tissue damage, the invention extracts this component completely and relies on the natural flexible distal tip of the catheter body to provide atraumatic properties during insertion and deployment.
Solution Approach 2:
The patent applies local quality by making only the distal tip segment of the catheter flexible and compliant, while the rest of the catheter body maintains its structural integrity. This localized flexibility at the distal end provides tissue safety without requiring a complex tip electrode structure throughout the entire device.
2Object-affected harmful factors
If a tip electrode is incorporated to prevent tissue damage, then tissue safety is improved, but manufacturing expense increases
Solution Approach 1:
The patent removes the tip electrode entirely from the catheter design. Instead of using a spherical or rounded tip electrode to prevent tissue damage, the invention extracts this component completely and relies on the natural flexible distal tip of the catheter body to provide atraumatic properties during insertion and deployment.
Solution Approach 2:
The patent applies local quality by making only the distal tip segment of the catheter flexible and compliant, while the rest of the catheter body maintains its structural integrity. This localized flexibility at the distal end provides tissue safety without requiring a complex tip electrode structure throughout the entire device.
3Object-affected harmful factors
If a ball of epoxy is used at the distal end to prevent tissue damage, then tissue safety is improved, but there is a risk of detachment within the body if not properly adhered
Solution Approach 1:
The patent segments the catheter into distinct functional zones, including a flexible distal tip segment that is integral to the catheter body. This segmentation allows the distal tip to be optimized for atraumatic performance while maintaining reliable mechanical integration with the rest of the catheter, eliminating the need for separate adhesive components that could detach.
Solution Approach 2:
The patent merges the protective function with the catheter structure itself by making the flexible distal tip an integral part of the catheter body. This integration eliminates the need for separate adhesive components like epoxy balls, as the atraumatic protection is built into the catheter's own structure through its flexible material composition and geometric design.
4Object-affected harmful factors
If a safety wire is included with a tip electrode to prevent tissue damage, then tissue safety is improved, but the inner diameter of the device becomes crowded
Solution Approach 1:
The patent removes the tip electrode entirely from the catheter design. Instead of using a spherical or rounded tip electrode to prevent tissue damage, the invention extracts this component completely and relies on the natural flexible distal tip of the catheter body to provide atraumatic properties during insertion and deployment.
Solution Approach 2:
The patent applies local quality by making only the distal tip segment of the catheter flexible and compliant, while the rest of the catheter body maintains its structural integrity. This localized flexibility at the distal end provides tissue safety without requiring a complex tip electrode structure throughout the entire device.
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
The flexible distal tip segment effectively reduces the likelihood of tissue damage during insertion and simplifies manufacturing by eliminating the need for a tip electrode, enhancing the safety and efficiency of cardiac procedures.
Implementation Method 1
a shape-memory wire extending through the lumen of the catheter body from the proximal segment and terminating at the distal end of the working segment
Implementation Method 2
The distal end of the shape-memory wire may be embedded in an adhesive, such as a UV-cured adhesive
Data Source
AI summary
A kit for the diagnosis or treatment of tissue in a body cavity includes an introducer and a catheter insertable through the lumen of the introducer having a proximal segment, a working segment and a flexible distal tip segment. The flexible distal tip segment is located adjacent the distal end of the working segment and includes a proximal end, a distal end and a pre-formed bend or curve that permits the catheter to exit the introducer in a lateral direction relative to the introducer body to prevent inadvertent damage to the tissue during a medical procedure. All or part of the working segment and the flexible distal tip segment may be adhesive-filled. The catheter may also include a plurality of sensing and/or energy delivery elements on the working segment and a shape-memory wire terminating at the distal end of the working segment. Methods of use and methods of manufacturing are also described.