Reversible Cutting Device for Controlled Catheter Incisions
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Solution Overview
Problem
Existing methods for deploying intravascular catheters, such as the Seldinger technique, are difficult and time-consuming, and can lead to complications like skin bridges, improper incision sizing, and increased risk of bloodstream infections due to inadequate skin sealing around the catheter entry site.
Innovation Solution
A cutting device with a reversible coupling mechanism and a movable cutting element is used to form a controlled incision in tissue, ensuring the incision extends from the puncture site and matches the diameter of the catheter, thereby preventing skin bridges and ensuring proper skin sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the Seldinger technique is used to deploy catheters, then access to target sites can be achieved, but the procedure becomes difficult and time-consuming with increased risk of complications
Solution Approach 1:
The cutting element is deployed in advance to create the incision before the catheter is inserted. This preliminary action ensures the incision is properly formed with correct dimensions and positioning, eliminating the need for manual incision creation during the catheter deployment procedure and reducing procedural complexity
Solution Approach 2:
The deployment procedure is segmented into distinct functional components: the cutting element for incision creation, the dilator for tissue dilation, and the catheter for final placement. This segmentation allows each component to be optimized for its specific function and simplifies the overall procedure by allowing sequential deployment of each component
2Ease of operation
If manual incision creation is performed during the Seldinger technique, then access can be established, but skin bridges and improper incision sizing occur leading to complications
Solution Approach 1:
The cutting element's position, orientation, and dimensions are pre-configured with precise parameters to match the required incision specifications. The cutting element can be positioned at specific distances from the dilator tip and angled to create incisions with precise length and orientation, ensuring proper fit for the catheter without manual adjustment
Solution Approach 2:
The cutting element is designed to automatically create the incision with correct positioning and dimensions when the dilator is advanced to the target site. The incision parameters are self-determined by the device geometry and deployment mechanics, eliminating the need for manual skill and judgment in creating the incision
3Productivity
If the incision is not properly formed, then catheter insertion becomes impossible or requires additional measures, but this increases procedure time and complexity
Solution Approach 1:
The incision is created as a preliminary step before catheter insertion, ensuring the pathway is properly prepared in advance. This prevents the need for additional corrective measures during catheter insertion and ensures smooth, efficient deployment without procedural delays
Solution Approach 2:
The cutting element and dilator are combined into a single integrated assembly that is deployed together over the guidewire. This merging ensures the incision and dilation steps are coordinated and completed in a single efficient motion, reducing procedure time and complexity
4Object-affected harmful factors
If the incision is too large, then bleeding occurs and infection risk increases, but proper incision sizing is difficult to achieve manually
Solution Approach 1:
The cutting element's dimensions and position are precisely controlled to create an incision of optimal size that matches the catheter diameter. The incision length and width are determined by fixed geometric parameters of the cutting element, ensuring consistent sizing that prevents both excessive bleeding and inadequate sealing
Solution Approach 2:
The device design incorporates feedback mechanisms where the incision dimensions are automatically adjusted based on the catheter size and deployment conditions. The cutting element geometry is selected or adjusted to match the required incision size, ensuring optimal fit and minimizing harmful effects
Data Source
AI summary
Systems, apparatus, and methods are described for forming an incision in tissue for receiving a surgical instrument. A cutting device for forming the incision can be reversibly coupleable to an instrument, e.g., a dilator. The instrument may define a lumen configured to receive a wire that extends or is otherwise extendable through a puncture site. The cutting device can include a cutting element configured to be actuated to form the incision such that the incision extends form the puncture site and is sized to receive the instrument.