Intraosseous Needle with Shielded Cutting Tip
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Solution Overview
Problem
Existing methods for accessing the interior of bones, such as for intraosseous infusion or bone marrow procedures, face challenges with sharp-tipped trocars that spin on hard bone surfaces, requiring cutting edges for penetration and often allowing tissue debris into the needle lumen.
Innovation Solution
A specialized needle with a distal cutting tip and an obturator that does not extend beyond the needle's distal face, coupled with a shield that prevents tissue debris entry and automatically transitions between unlocked and locked states to secure the obturator, facilitating effective bone penetration and access.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a sharp-tipped trocar is used to penetrate hard bone, then initial tissue penetration is improved, but the trocar spins on the bone surface and fails to penetrate effectively
Solution Approach 1:
The device is divided into two functional segments: a sharp-tipped trocar for initial tissue penetration and a separate cutting edge on the needle for bone penetration. The trocar is inserted first to create the initial puncture, then the cutting edge engages to rotate and penetrate the hard bone surface, solving the problem of the trocar spinning without penetrating.
Solution Approach 2:
The sharp-tipped trocar performs a preliminary action by penetrating the soft tissue and skin before the needle's cutting edge engages with the bone. This preliminary tissue penetration creates a pathway that allows the subsequent cutting edge to effectively engage and rotate on the bone surface without spinning uselessly.
2Reliability
If cutting edges are added to the needle for bone penetration, then bone penetration capability is improved, but tissue debris can enter the needle lumen
Solution Approach 1:
The harmful function of the cutting edge generating debris is separated from the needle lumen by introducing a shield. The shield is positioned between the cutting edge and the needle lumen, extracting the debris-generating action from the pathway to the lumen and redirecting debris away from the infusion pathway.
Solution Approach 2:
A shield acts as an intermediary component between the cutting edge and the needle lumen. This intermediary structure allows the cutting edge to perform its bone-penetrating function while simultaneously blocking tissue debris from entering the needle lumen, thus mediating between the conflicting requirements of penetration capability and contamination prevention.
3Strength
If the obturator extends beyond the needle distal face, then insertion support is improved, but it prevents proper shielding and increases debris entry risk
Solution Approach 1:
The obturator is designed with local quality differentiation: it provides maximal support and strength within the needle lumen where needed for insertion, but terminates before the distal face to allow the shield to function properly at the critical interface with the bone surface. This localized adjustment maintains insertion support while eliminating the harmful effect of debris entry.
4Object-affected harmful factors
If a shield is added to prevent debris entry, then contamination protection is improved, but device complexity increases
Solution Approach 1:
The shield is merged with the existing needle and obturator components rather than being a completely separate assembly. It integrates into the overall device structure, combining the protection function with the existing penetration mechanism, thus reducing the increase in device complexity while maintaining contamination protection.
Data Source
AI summary
An intraosseous access system can include a needle that defines a lumen and a longitudinal axis about which the needle can be rotated during an insertion event. The needle can include a proximal end that remains at an exterior of a patient during use, a distal end that can be inserted through the skin of the patient into contact with a bone of the patient, and a distal tip at a distalmost point of the distal end of the needle that is positioned at the longitudinal axis of the needle. The system can further include an obturator sized to be received within the lumen of the needle that can inhibit material from entering the needle as the system is inserted into the bone.