Phlebotomy Introducer with Movable Guide Member
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Solution Overview
Problem
Current methods for phlebotomy through peripheral intravenous catheters are inefficient, with high failure rates due to issues like hemolysis, vein rupture, and debris buildup, leading to increased patient discomfort, material waste, and labor costs.
Innovation Solution
A system comprising a catheter with a proximal and distal end, an introducer with a locking mechanism, and an actuator that moves the catheter between configurations to facilitate blood extraction through a peripheral IV line, minimizing vein rupture and debris issues.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a peripheral IV catheter is used for blood extraction, then the need for repeated needle sticks is reduced, but the failure rate increases due to mechanical barriers such as catheter collapse and debris buildup
Solution Approach 1:
The device is divided into multiple functional segments: an introducer sheath that interfaces with the existing IV catheter, a movable guide member that provides structural support, and a blood collection system. This segmentation allows each component to address specific mechanical barriers while working together to improve overall reliability.
Solution Approach 2:
The guide member acts as an intermediary between the soft IV catheter and the blood collection system. It provides the necessary structural support and rigidity to prevent catheter collapse during aspiration, while allowing the IV catheter to remain in place. This intermediary structure resolves the contradiction by enabling reliable blood extraction through the existing IV access.
2Productivity
If negative pressure is applied for aspiration through the catheter, then blood extraction is achieved, but the catheter tip adheres to the vein wall creating a suction cup effect that can cause vein rupture
Solution Approach 1:
The guide member serves as a mediator between the aspiration force and the catheter tip. It distributes and controls the negative pressure application, preventing direct adhesion of the catheter tip to the vein wall. This intermediary structure allows efficient blood extraction while mitigating the harmful suction cup effect that could cause vein rupture.
Solution Approach 2:
The device modifies the pressure distribution parameters during aspiration. By using the guide member to control and distribute the negative pressure, the system changes from concentrated high-pressure application (which causes adhesion) to distributed controlled pressure application (which prevents adhesion while maintaining extraction efficiency).
3Duration of action of stationary object
If the catheter is left inserted for extended periods, then continuous IV access is maintained, but debris buildup on the catheter tip increases failure rates
Solution Approach 1:
The device extracts the blood collection function from the existing IV catheter system by using the introducer and guide member assembly. This allows the IV catheter to remain for continuous access while the separate blood collection system performs phlebotomy, preventing debris buildup on the IV catheter tip and maintaining both long-term access reliability and blood extraction success.
4Productivity
If a movable guide member is used to extend the catheter beyond the IV line, then blood extraction efficiency is improved, but the device complexity increases
Solution Approach 1:
The device uses a nested structure where the guide member is disposed within the introducer sheath, and the blood collection components are integrated within the guide member. This nesting arrangement provides the necessary complex functionality for efficient blood extraction while maintaining a compact form factor and manageable operational complexity.
Data Source
Figure 1~2
Figure 3~4
Figure 5~6A
AI summary
An apparatus includes a catheter having a proximal end portion and a distal end portion, the catheter defining a lumen extending through the proximal end portion and the distal end portion of the catheter and an introducer defining an inner volume. The introducer having a distal end portion configured to be coupled to an indwelling peripheral intravenous line. The introducer configured to transition between a first configuration, in which a catheter protector is disposed within the introducer, and a second configuration, in which at least a distal end portion of the catheter protector is distal to the introducer and within the indwelling peripheral intravenous line. An actuator coupled to the catheter and configured to transition the introducer between the first configuration and the second configuration, at least the distal end portion of the catheter being isolated within the catheter protector and moving with the catheter protector as the introducer is transitioned from the first configuration to the second configuration. The actuator configured to move the catheter relative to catheter protector when the introducer is in the second configuration such that the distal end portion of the catheter is distal to the catheter protector.