Integrated Aspiration Needle Assembly for Intraosseous Access Confirmation
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Solution Overview
Problem
Existing intraosseous access systems face challenges in confirming access to the medullary cavity, requiring disassembly and reassembly of the needle assembly to aspirate bone marrow, which can lead to loss of patency and increased risk of needle stick injuries.
Innovation Solution
An intraosseous access system with an integrated aspiration system that includes a syringe or vacutainer, allowing for aspiration without disengaging the needle assembly, using a drive train to rotate the needle and create a vacuum for fluid communication, and featuring a transparent housing for visual confirmation of bone marrow access.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If the needle assembly is disengaged from the drill and the obturator is withdrawn from the needle lumen to aspirate bone marrow, then confirmation of medullary cavity access is achieved, but the needle cannot be reused and the clinician must withdraw the needle and couple a new needle assembly to the drill
Solution Approach 1:
The aspiration system is integrated into the needle assembly, combining the aspiration function with the needle structure. The syringe barrel is coupled to the needle assembly, allowing aspiration to be performed while the needle remains engaged with the drill, eliminating the need to disengage and reuse the needle.
Solution Approach 2:
The needle assembly is designed to serve multiple functions: drilling through the bone cortex and aspirating bone marrow. The integrated syringe barrel allows the same needle assembly to perform both drilling and aspiration, making it a multi-functional device that eliminates the need for needle exchange.
2Measurement precision
If the needle assembly is disengaged from the drill to aspirate bone marrow, then confirmation of medullary cavity access is achieved, but patency of the original access site may be lost during needle exchange
Solution Approach 1:
The aspiration system is integrated into the needle assembly, combining the aspiration function with the needle structure. The syringe barrel is coupled to the needle assembly, allowing aspiration to be performed while the needle remains engaged with the drill, eliminating the need to disengage and reuse the needle.
Solution Approach 2:
The needle assembly remains continuously engaged with the drill throughout the procedure. The integrated aspiration system allows bone marrow aspiration to be performed without withdrawing the needle, maintaining continuous patency of the access site and eliminating interruptions in the drilling action.
3Ease of operation
If the obturator is withdrawn from the needle lumen to provide fluid communication for aspiration, then bone marrow can be aspirated, but the needle assembly must be disassembled and reassembled
Solution Approach 1:
The aspiration system is integrated into the needle assembly, combining the aspiration function with the needle structure. The syringe barrel is coupled to the needle assembly, allowing aspiration to be performed while the needle remains engaged with the drill, eliminating the need to disengage and reuse the needle.
Solution Approach 2:
The syringe barrel is pre-coupled to the needle assembly in a ready-to-aspirate configuration. The obturator can be withdrawn and the aspiration system activated without requiring disassembly or reassembly of the needle assembly, as all components are already positioned and connected.
4Productivity
If a powered drill is used to rotate the needle assembly at high rotational speeds to drill through the bone cortex, then efficient access to medullary cavity is achieved, but detecting when the needle has accessed the medullary cavity becomes challenging
Solution Approach 1:
The integrated aspiration system provides real-time feedback about medullary cavity access. When the needle tip enters the medullary cavity, bone marrow can be aspirated and observed in the syringe barrel, providing immediate visual confirmation of successful access while the needle remains engaged with the drill.
Solution Approach 2:
The syringe barrel acts as an intermediary system that facilitates detection of medullary cavity access. By providing a controlled fluid communication pathway, the syringe allows bone marrow to be drawn into the barrel for visual observation, serving as a mediator between the drilling action and the detection of successful access.
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
Enables confirmation of medullary cavity access without disassembly, maintaining needle patency, and reducing the risk of needle stick injuries by allowing continuous aspiration through a transparent observation of fluid flow.
Implementation Method 1
a drive train disposed within the housing and configured to rotate the needle assembly and one of a syringe barrel or a vacutainer canister about the longitudinal axis
Implementation Method 2
the aspiration system configured to slide the obturator relative to the needle and selectively provide a vacuum in fluid communication with the needle lumen
Data Source
AI summary
Embodiments disclosed herein are directed to an intraosseous access system configured to confirm access to a medullary cavity. The system includes a driver housing, an access system including a drive train, a needle assembly rotatably coupled to the access system, and an aspiration system. The needle assembly can include a needle defining a lumen and an obturator disposed therein. The aspiration system can include a syringe or a vacutainer, coupled to the obturator. Sliding one of a plunger or a vacutainer proximally can withdraw the obturator from the needle lumen and place a vacuum in fluid communication with the needle lumen to draw a fluid flow therethrough. A portion of the aspiration system can rotate along with the needle assembly. Withdrawing the obturator can place the obturator within the syringe or the vacutainer mitigating needle stick injuries. If the medullary cavity has not been accessed, the obturator can be replaced.