Two-Piece Catheter Connector for Split Handle Reuse
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Solution Overview
Problem
Electrophysiology catheters are typically sold as single-use devices due to concerns about proper cleaning and potential damage to electronic circuitry during reprocessing, limiting their reuse.
Innovation Solution
A catheter design featuring a split-handle with a two-piece connector that separates electronic circuitry from the operator-controlled handle, allowing for easier reprocessing and reuse by facilitating the placement of components in various portions of the connector, with a keyed design and latching mechanisms for secure connection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If electrophysiology catheters are designed as single-use devices with integrated electronic circuitry in the handle, then reliability and ease of operation are improved, but device complexity increases and reuse is prevented due to concerns about cleaning and potential damage to electronic circuitry during reprocessing
Solution Approach 1:
The handle assembly is divided into two separate pieces: a reusable handle body and a disposable catheter portion with connector. This segmentation allows the electronic circuitry to remain in the reusable handle while the disposable portion can be easily reprocessed, resolving the contradiction between reliability (maintaining electronics) and ease of reprocessing (disposing of contaminated parts).
Solution Approach 2:
The electronic circuitry is extracted from the disposable catheter portion and placed solely in the reusable handle body. This extraction eliminates the risk of damage to electronic components during reprocessing of the catheter, allowing the catheter to be reused while protecting the reliability of the electronic systems.
2Ease of manufacture
If electrophysiology catheters are designed as single-use devices, then ease of reprocessing is improved, but loss of substance increases due to disposal of functional components
Solution Approach 1:
By segmenting the catheter system into reusable and disposable portions, valuable components such as electronic circuitry, batteries, and control mechanisms are preserved in the reusable handle, while only the sterile catheter shaft is disposed of. This reduces waste of functional components while maintaining ease of reprocessing for the disposable portion.
3Adaptability or versatility
If a two-piece connector is implemented to enable reuse, then adaptability and ease of reprocessing are improved, but device complexity increases due to additional connection mechanisms
Solution Approach 1:
A specialized connector serves as an intermediary component that interfaces between the reusable handle and the disposable catheter portion. This connector incorporates keyed designs and latching mechanisms to ensure secure, reliable connections while maintaining relatively simple overall device architecture. The connector enables adaptability for reuse without excessively increasing device complexity.
4Ease of manufacture
If electronic circuitry is separated from the handle in a two-piece connector design, then ease of reprocessing is improved, but reliability may worsen due to potential connection issues between separate components
Solution Approach 1:
The connector acts as a reliable intermediary that ensures stable electrical and mechanical connections between the handle and catheter portion. It incorporates keyed designs to prevent misalignment and latching mechanisms to secure the connection, thereby maintaining reliability while enabling easy reprocessing of the disposable portion.
Solution Approach 2:
The connector is pre-designed and pre-assembled with integrated electrical contacts and locking features before use. This preliminary preparation ensures that when the disposable catheter portion is connected to the reusable handle, the connection is immediately secure and reliable, eliminating potential connection issues during the procedure.
Data Source
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AI summary
A catheter and method for the treatment of a patient having atrial flutter or other arrhythmia comprises an elongated catheter body having an outer wall, proximal and distal ends, and at least one lumen extending therethrough. Further it has a distal tip section comprising a flexible tubing having a proximal end and a distal end and a plurality of lumens extending therethrough. The proximal end of the tip section is fixedly attached to the distal end of the catheter body. The tip section further comprises a nitinol tube having slots formed therein which causes the distal tip section to deflect using the same puller-wire action used to cause the deflectable catheter to deflect at a point proximal to the distal tip section.