Reference Array Clamp With Drape Shift Compensation
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Solution Overview
Problem
Existing connectors for reference arrays in image-guided surgery systems compromise sterility and accuracy due to the need to cut drapes for mounting, causing positional shifts that render registration results obsolete or inaccurate when drapes are applied.
Innovation Solution
A drape-clamping connector with a support below the drape and a clamping element above, using multiple clamps distributed along parallel flat surfaces to compensate for positional shifts, ensuring the reference array remains in a fixed position whether draped or undraped, thereby maintaining sterility and accuracy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the drape is cut to allow the connector to protrude for mounting the reference array, then the reference array can be mounted above the drape, but sterility is compromised
Solution Approach 1:
The drape is introduced as an intermediary element between the connector and the reference array. The connector clamps the drape to hold the reference array, allowing the drape to serve as a sterile barrier while still enabling secure mounting. This resolves the contradiction by using the drape itself as the mounting medium rather than cutting through it.
Solution Approach 2:
The solution utilizes the flexible nature of the drape (a thin film) by clamping it between the connector components. The drape's flexibility allows it to be compressed and held in place without breaking sterility, enabling the reference array to be mounted while maintaining the intact sterile barrier.
2Reliability
If the drape is clamped between the connector interface and the reference array interface, then sterility is maintained, but the positional relationship between the array and connector shifts
Solution Approach 1:
The connector design incorporates compliance or flexibility parameters that allow it to accommodate the drape thickness without creating positional shifts. The connector may include compliant elements or adjustable mechanisms that adapt to the presence of the drape, maintaining the positional relationship between the reference array and the connector despite the added layer.
3Ease of operation
If a threaded interface connector is used to clamp the drape, then the reference array can be held above the drape, but the threading mechanism creates positional instability
Solution Approach 1:
The solution replaces the traditional threaded mechanical interface with a clamp-based mechanical system. Instead of using threads that can shift or loosen, the connector uses a clamp mechanism that applies uniform pressure to hold the drape and reference array in a stable, fixed position without the rotational movement inherent in threaded connections.
Data Source
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AI summary
The invention relates to a connector (1) for attaching a reference array (72) in a fixed positional relationship with respect to a patient, wherein the patient is to be covered by a sterile drape in the attachment area, the connector (1) comprising: a support (12) which is to be situated below the drape (30); and a clamping element (14) which is to be situated above the drape and can directly or indirectly hold the reference array (72) or a reference array adaptor, wherein the clamping element (14) clamps the support (12), with the drape (30) caught between the two, by means of at least two distinct clamps (16) which clamp the support (12) from at least partly opposing directions in such a way that the positional shift in the clamping element (14) as a result of clamping the drape (30) at the clamping position is compensated for, such that its overall positional shift is substantially zero. The invention also relates to a connector arrangement (2) comprising such a connector (1) and to a method for attaching a reference array (72) in a fixed positional relationship with respect to a patient.