Powered Driver Coupler for Intraosseous Biopsy Needle Insertion
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Solution Overview
Problem
Current methods for accessing and retrieving bone marrow are difficult, traumatic, and often require substantial manual force, leading to patient discomfort, potential bone damage, and increased risks for both patients and healthcare personnel due to the need for multiple insertions and handling of sharp instruments.
Innovation Solution
A powered driver and coupler assembly system for inserting and rotating an aspiration or biopsy needle into bone, combined with a containment bag for sterile operation, reduces physical requirements and enhances control, speed, and safety by minimizing manual force and needle handling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If manual force is applied to insert the biopsy needle through the bone cortex, then the needle can penetrate the bone, but it causes pain and potential damage to the bone and device
Solution Approach 1:
The patent replaces manual mechanical insertion with a powered driver system that uses rotational motion and controlled mechanical advantage to penetrate the bone cortex. The driver assembly converts rotational movement into linear advancement of the needle, reducing the need for direct manual force application and thereby minimizing patient pain and risk of bone damage.
Solution Approach 2:
The needle assembly incorporates dynamic elements including a rotatable needle that can be spun during insertion to facilitate bone penetration. The powered driver provides dynamic control over insertion speed and force, allowing optimization of the penetration process to reduce trauma while maintaining effectiveness.
2Quantity of substance
If multiple insertion sites are used to obtain sufficient bone marrow, then adequate specimen quantity can be achieved, but the risk to healthcare personnel increases due to increased handling of contaminated instruments
Solution Approach 1:
The powered driver system is designed as a universal platform that can be used for multiple bone marrow aspiration sites without requiring setup changes. The system maintains sterile integrity throughout multiple insertions, and the standardized procedure reduces variability and potential errors that could compromise safety. The driver can accommodate different needle types and configurations for various anatomical sites.
Solution Approach 2:
The powered driver acts as an intermediary between the operator and the contaminated needle instruments. By automating the insertion and withdrawal processes, it minimizes direct hand-to-hand passing of contaminated instruments among healthcare personnel, thereby reducing needlestick risks while enabling multiple safe insertions to obtain adequate specimen quantity.
3Device complexity
If conventional manual techniques are used for bone marrow aspiration, then the procedure can be performed with simple equipment, but operator fatigue and loss of control occur
Solution Approach 1:
The powered driver system performs the physically demanding aspects of bone marrow aspiration automatically, including bone penetration and needle advancement. The operator simply needs to position the device and activate the driver, which then self-regulates the insertion process. This automation eliminates operator fatigue while maintaining precise control throughout the procedure.
4Speed
If substantial manual force is exerted to break through the bone cortex, then the needle can penetrate, but the procedure becomes traumatic and time-consuming
Solution Approach 1:
The powered driver provides dynamic control over insertion parameters, allowing the needle to rotate and advance through the bone cortex at optimized speeds. The system can adjust rotational speed and feed rate in real-time based on resistance encountered, enabling rapid penetration while minimizing traumatic effects on the bone and surrounding tissues.
Data Source
AI summary
Apparatus and methods are provided to remove biopsy specimens from a bone and/or associated bone marrow using a powered drive and an intraosseous (IO) needle set. The powered driver may rotate the IO needle set at an optimum speed to obtain a biopsy sample of bone and/or bone marrow. Apparatus and methods may also be provided for aspiration of bone marrow and/or stem cell transplant procedures. The apparatus may include a powered driver, a coupler assembly, a containment bag or sterile sleeve and various IO needles and IO needle sets with associated hubs and/or hub assemblies. Each IO needle set may include a cannula or catheter and an associated trocar stylet with respective tips operable to penetrate a bone and/or bone marrow with minimum trauma to a patient. Each hub assembly may be used to releasably dispose a respective stylet within an associated generally hollow cannula. Some coupler assemblies and/or hub assemblies may also be used with manual drivers.