Drape-Clamping Reference Array Connector With Shift Compensation
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Solution Overview
Problem
In image-guided surgery systems, attaching a reference array while maintaining sterility and accuracy is challenging due to the need for the array to be visible to detectors, which often requires cutting sterile drapes, compromising sterility and causing positional shifts that render registration results obsolete.
Innovation Solution
A drape-clamping connector with a support below the drape and a clamping element above, using distinct clamps to compensate for positional shifts, ensuring the reference array remains in a fixed position whether draped or undraped, thus preserving sterility and accuracy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the drape is cut to allow the connector to protrude through, then the reference array can be mounted above the drape for visibility, but the sterility of the drape is compromised
Solution Approach 1:
The connector is designed with a nested structure where the reference array holder is inserted into the connector body, which itself is inserted through the drape. The connector comprises an outer shell that passes through the drape and an inner holder that receives the reference array, creating a nested configuration that maintains sterility while enabling visibility.
Solution Approach 2:
The connector acts as an intermediary element between the sterile field (below the drape) and the non-sterile field (above the drape). It provides a sealed interface that allows the reference array to be positioned above the drape for detector visibility while maintaining the sterility barrier of the drape itself.
2Reliability
If the reference array is attached below the drape, then sterility is maintained, but the array is not visible to the detector for accurate tracking
Solution Approach 1:
The reference array is nested within a holder that is itself nested within the connector structure. This nested arrangement allows the array to be physically positioned above the drape (for detection) while the connector maintains the sterile barrier, thus resolving the contradiction between sterility and detectability.
3Reliability
If the drape is clamped between the connector interface and the array interface, then sterility is maintained, but the positional relationship between the array and connector shifts
Solution Approach 1:
The connector is designed with pre-calculated compensation features that anticipate and counteract the positional shift caused by drape clamping. The holder includes adjustment mechanisms or positioning features that are configured to offset the expected displacement, thereby maintaining accurate positional relationship despite the presence of the clamped drape.
Solution Approach 2:
The connector design incorporates adjustable parameters such as clamp position, holder orientation, or array positioning that can be modified to compensate for drape thickness variations and clamping-induced shifts. This allows the system to maintain precise positional relationships despite the intermediate drape layer.
Data Source
AI summary
A connector for attaching a reference array in a fixed positional relationship with respect to a patient to be covered by a sterile drape in an attachment area, includes a support to be situated below the drape and a clamping element which is to be situated above the drape and can directly or indirectly hold the reference array or a reference array adaptor, wherein the clamping element clamps the support, with the drape caught between the two, by at least two distinct clamps which clamp the support from at least partly opposing directions in such a way that the positional shift in the clamping element as a result of clamping the drape at the clamping position is compensated for, such that its overall positional shift is substantially zero. A method attaching a reference array in a fixed positional relationship relative to a patient above a sterile drape is also provided.