Manual Intraosseous Device With Tactile Depth Limiting
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Solution Overview
Problem
Existing intraosseous (IO) devices lack a mechanism to reliably limit penetration depth into bone cortex, leading to potential overpenetration and injury to surrounding tissues or organs, especially in infants and adults with varying bone thickness and subcutaneous tissue, and fail to provide clear feedback on achieving the correct depth.
Innovation Solution
A manual intraosseous device with a penetration depth limiting mechanism using separate elements that secure at the predetermined depth, providing tactile feedback and preventing further displacement, along with a stabilizer for precise site alignment and a flexible transfusion tube for secure connection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a manual intraosseous device is used to penetrate bone cortex, then bone marrow access is achieved, but overpenetration may occur causing injury to surrounding tissues or organs
Solution Approach 1:
The device incorporates a penetration depth limiting mechanism with a stopper element that is positioned in advance at the predetermined depth within the inner sleeve. This preliminary positioning of the stopper prevents overpenetration by mechanically blocking further distal displacement of the bone portal before harmful injury can occur to surrounding tissues or organs.
Solution Approach 2:
The device provides tactile feedback through the engagement between the bone portal and the stopper element at the predetermined depth. When the bone portal reaches the correct depth, the stopper engages with the bone portal, providing a distinct tactile sensation to the operator that penetration depth has been achieved, thereby preventing excessive penetration and associated injuries.
2Measurement precision
If penetration force is continuously applied to ensure adequate penetration, then bone portal is introduced to sufficient depth, but surrounding tissues may be injured due to excessive force
Solution Approach 1:
The stopper element is pre-positioned within the inner sleeve at the predetermined penetration depth before the procedure begins. This preliminary placement ensures that when the bone portal is advanced, it will automatically engage with the stopper at the correct depth, providing precise depth control and preventing excessive force application that could injure surrounding tissues.
Solution Approach 2:
The engagement between the bone portal and the stopper provides immediate tactile feedback to the operator when the predetermined depth is reached. This feedback mechanism allows the operator to recognize that sufficient penetration has been achieved and to cease applying force, thereby preventing tissue injury from excessive penetration force.
3Ease of operation
If the bone portal is allowed to move freely during penetration, then the operator can adjust depth, but consistent predetermined depth cannot be maintained
Solution Approach 1:
The stopper element is pre-positioned at the predetermined depth within the inner sleeve, establishing a fixed reference point before penetration begins. This preliminary positioning ensures that regardless of operator manipulation during the procedure, the bone portal will consistently engage with the stopper at the correct depth, maintaining depth consistency while still allowing operational flexibility.
Solution Approach 2:
The tactile feedback from the stopper engagement provides a reliable indicator to the operator when the predetermined depth has been reached. This feedback mechanism allows the operator to maintain consistent depth by recognizing the engagement sensation, while still permitting flexible adjustment during the penetration process.
4Reliability
If a depth limiting mechanism is added to the device, then overpenetration is prevented, but device complexity increases
Solution Approach 1:
The depth limiting mechanism is segmented into separate functional elements: a stopper element positioned within the inner sleeve, and a corresponding engagement feature on the bone portal. This segmentation allows the mechanism to be implemented using simple, discrete components rather than a complex integrated system, maintaining reliability while minimizing structural complexity.
Solution Approach 2:
The depth limiting function is extracted as a separate stopper element that can be independently positioned within the inner sleeve, rather than being integrated into the entire device structure. This extraction allows the mechanism to be added with minimal impact on overall device complexity, as the stopper is a simple component that interfaces only with the bone portal during penetration.
Data Source
AI summary
A manual intraosseous (IO) device for introducing a bone portal to a predetermined depth relative to a surface of a target bone, and methods for using same. The device is manually actuated and configured to limit the depth of penetration of a bone portal into a bone cortex independently of an applied driving force and independently of subcutaneous tissue thickness surrounding the bone cortex, while providing terminal feedback that the bone portal has been penetrated to the predetermined depth. The device has transfusion facilitating components that remain fixed at the penetration site following penetration of the bone portal to the predetermined depth and releasable components that are separated from the transfusion facilitating components prior to a transfusion operation. The device may also include a stabilizer, or base, that allows a health practitioner to easily locate the insertion site and allows low profile fixation of the IO transfusion component (IOcatheter).