Sterile Sheath for Surgical Instrument Positioning
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Solution Overview
Problem
Existing robot-assisted surgical procedures face challenges in maintaining sterility around the intervention site due to the risk of contamination from robots and the need for frequent and time-consuming changes of sterile covers, especially in micro-invasive procedures where the distance between robot holders and needles is minimal.
Innovation Solution
A sterile, balloon-like sheath surrounds the surgical instrument, providing a gas-tight environment with a passage for the instrument holder, allowing controlled movement and attachment with an adhesive surface, and includes features like a peelable protective film, retaining ring, and an inlet valve for sterilizing gas supply to maintain sterility and prevent contamination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If the robot is placed close to the needle for precise positioning, then positioning precision is improved, but the risk of contamination increases
Solution Approach 1:
The system is divided into a sterile zone (containing the needle and immediate surroundings) and a non-sterile zone (containing the robot). The sterile barrier physically separates these zones, allowing the robot to operate close to the needle without compromising sterility. This segmentation resolves the contradiction by enabling close positioning while preventing contamination through spatial division.
Solution Approach 2:
A sterile barrier (drape or sheath) acts as an intermediary between the non-sterile robot and the sterile needle. This intermediary component allows mechanical force and positioning control to be transmitted from the robot to the needle while maintaining the sterile boundary, thus enabling precise positioning without direct contact between sterile and non-sterile elements.
2Reliability
If sterile covers are used to protect the robot, then sterility is improved, but the complexity of changing covers increases
Solution Approach 1:
The sterile barrier is extracted as a separate, disposable component that can be independently changed without affecting the robot or other system components. This allows the sterile cover to be replaced quickly by simply removing and attaching new barriers, reducing the complexity of the change procedure while maintaining sterility reliability.
Solution Approach 2:
The sterile barrier is designed as a disposable component rather than a reusable part of the robot. This allows frequent changes of sterile covers without the need for complex sterilization procedures or robot disassembly, thereby maintaining high sterility reliability while keeping the change procedure simple and cost-effective.
3Ease of operation
If the robot structure is simplified for ease of use, then ease of operation is improved, but the ability to maintain sterile atmosphere worsens
Solution Approach 1:
The system separates the robot (non-sterile, simple structure) from the sterile field (maintained by independent barriers). This segmentation allows the robot to have a simple, easy-to-operate structure without needing integrated sterile maintenance features, while the sterile atmosphere is maintained by separate barrier components that do not complicate the robot design.
Solution Approach 2:
Sterile barriers serve as intermediaries between the simple robot structure and the sterile field requirements. These intermediaries handle the complexity of sterile maintenance, allowing the robot itself to remain structurally simple and easy to operate while still maintaining the sterile atmosphere through the barrier system.
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
The solution ensures high sterility at the intervention site, reduces the need for frequent sterile cover changes, and allows for efficient and cost-effective implementation of micro-invasive procedures, even in non-sterile environments, by maintaining a sterile atmosphere and reducing exposure to radiation during imaging techniques.
Implementation Method 1
at least one adhesive surface (7') is provided on the sheath (3) for bonding the sheath (3) in a gas-tight manner at the body part (P') of the patient
Implementation Method 2
the sheath (3) is formed from a gas-permeable or gas-impermeable material, in particular from an elastomeric material or a plastic material
Data Source
AI summary
In order to provide a simple device for positioning sterile instruments, particularly puncture needles, injection needles or surgical probes, with respect to a patient (P), where said device comprises a sheath (3) at least the inside of which is sterile and which at least partially encompasses a sterile instrument (2), as well as at least one gas-tight feedthrough provided on said sheath (3), it is suggested that the sterile instrument (2) has at least one sterile instrument holder (2′) and that, by moving the instrument holder (2′) outside of the sheath (3), said instrument may be moved in a controlled manner in at least two spatial directions.


