Removable Medical Navigation Sheath with Deformable Fixation
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Solution Overview
Problem
Existing navigation systems for medical devices within the body are costly, complex, and often incompatible with the medical device's materials and functions, particularly for procedures requiring high flexibility and biocompatibility, and may compromise the device's performance.
Innovation Solution
A removable navigation system comprising a sheath with a positioning sensor and a deformable fixation element that temporarily fixes the sheath to the medical device, allowing for temporary navigation capabilities without permanent integration, using materials like shape memory alloys, pressurized ferrules, or inflatable elements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a navigation system is permanently integrated into the medical device, then positioning accuracy is improved, but device flexibility and biocompatibility are compromised
Solution Approach 1:
The navigation system is segmented into a separate sheath component that can be independently attached to or removed from the medical device. The sheath contains the positioning sensor and fixation elements, while the medical device maintains its original flexible structure and biocompatible materials. This segmentation allows the navigation capability to be added without compromising the device's flexibility or biocompatibility.
Solution Approach 2:
The sheath acts as an intermediary component between the medical device and the navigation system. It provides the positioning sensor and fixation mechanisms while allowing the medical device to maintain its original design characteristics. The sheath can be temporarily attached to enable navigation during the procedure, then removed, thus serving as a mediator that adds functionality without permanent integration.
2Measurement precision
If navigation components are permanently affixed to the medical device, then positioning tracking is improved, but device complexity and cost increase
Solution Approach 1:
The fixation elements are designed to be dynamically changeable between engaged and disengaged states. The deformable fixation elements can be temporarily deformed to attach the sheath to the medical device, providing positioning tracking when needed, then returned to their original state to release the sheath. This dynamic capability allows the system to transition between different operational states without permanent complexity.
Solution Approach 2:
The sheath with navigation components can be discarded after a single use or recovered for reuse. The deformable fixation elements are designed to be reset after use, allowing the sheath to be removed and potentially reused. This approach reduces long-term system complexity compared to permanent integration, as the navigation components can be separated and managed independently.
3Measurement precision
If a sheath with positioning sensor is used, then navigation capability is added, but relative motion between device and sensor occurs
Solution Approach 1:
The deformable fixation elements are pre-configured to engage with the medical device before the procedure begins. By preliminarily establishing the mechanical connection between the sheath and device, the system ensures stable relative positioning from the start of the procedure, eliminating drift that would occur with adhesive-only or friction-based attachments.
Solution Approach 2:
The patent replaces weak mechanical attachment methods (such as friction or adhesives) with a deformable fixation element mechanism that provides positive mechanical engagement. The fixation element deforms to engage with features on the medical device, creating a stable mechanical connection that prevents relative motion between the positioning sensor and the device during the procedure.
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 low-cost, flexible navigation of medical devices while minimizing alterations to the device's performance and ensuring biocompatibility, allowing for precise tracking and operation without long-term integration issues.
Implementation Method 1
using materials like shape memory alloys, pressurized ferrules, or inflatable elements
Implementation Method 2
a deformable fixation element disposed between the sheath and the medical device, the deformable fixation element operatively deformed to temporarily fix a position
Data Source
AI summary
A removable navigation system for a medical device configured for insertion within a lumen in a body is provided. The removable navigation system includes a sheath operatively configured to cover at least a portion of the medical device, a positioning sensor affixed to the sheath and a deformable fixation element disposed between the sheath and the medical device. The deformable fixation element is operatively deformed to temporarily fix a position of the medical device relative to the sheath and positioning sensor.