Reference Array Connector With Opposing Clamps for Sterile Accuracy
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Solution Overview
Problem
Existing connector arrangements for reference arrays in image-guided surgery systems compromise sterility and accuracy due to the need to cut sterile drapes for visibility, leading to positional shifts that render registration results obsolete or inaccurate.
Innovation Solution
A drape-clamping connector arrangement with a support below the drape and a clamping element above, using multiple clamps to compensate for positional shifts, ensuring the reference array remains in a fixed position regardless of draping, thereby maintaining sterility and accuracy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If the drape is cut to allow the reference array to protrude for visibility, then the reference array becomes visible to the detector, but sterility is compromised
Solution Approach 1:
The connector is divided into two distinct parts: a lower connector portion that remains below the drape and an upper connector portion that extends above the drape. This segmentation allows the reference array to be visible while maintaining the integrity of the drape and sterility.
Solution Approach 2:
The connector acts as an intermediary element that bridges the space below and above the drape. It transmits the reference array position while allowing the drape to remain intact, thus maintaining sterility without compromising visibility.
2Reliability
If the drape is clamped between the connector interface and the array interface, then sterility is maintained, but positional shift occurs rendering registration results inaccurate
Solution Approach 1:
By separating the connector into lower and upper portions that connect to each other above the drape, the system eliminates the need to clamp the drape between interfaces. This segmentation allows the drape to be clamped by a separate clamping element without affecting the positional relationship between the reference array and the connector.
Solution Approach 2:
The clamping element serves as an intermediary that secures the drape without interfering with the precise positional relationship between the reference array and the connector. It allows the drape to be held in place while maintaining measurement accuracy.
3Measurement precision
If the reference array is attached close to the treatment location for high accuracy, then navigational accuracy is improved, but maintaining sterility becomes more difficult
Solution Approach 1:
The connector's segmented design allows the reference array to be positioned close to the treatment location while the upper connector portion extends above the drape. This enables high navigational accuracy without compromising sterility, as the drape remains intact around the treatment area.
Data Source
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AI summary
A connector arrangement (2) 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 arrangement (2) comprising: - a first connector (1) having a first clamping unit (13) which includes 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, and - a second clamping unit (23) which is clamped onto the first clamping unit (13).